October 2014 by McMahon Group

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Citing Past Successes, New Focus Is Entire Perioperative Period Stockholm—Professor Francois Clergue, director of anesthesia of the University Hospitals of Geneva, challenged attendees of the European Society of Anaesthesiology (ESA) annual meeting here to extend their demonstrated success in improving anesthesia safety to address the entire perioperative period. The goal: Reduce postoperative mortality by 20%. Dr. Clergue, delivering the Sir Robert Macintosh Lecture, discussed the

IV Induction Doses in Elderly Reduced, But Still Trend High New Orleans—Anesthesiologists are adjusting induction doses of fentanyl, propofol and midazolam in older patients to account for age, but the reduced doses nonetheless have a tendency to hover at the upper end of recommended limits for these oftenfragile patients, leaving the door ajar to a host of potential complications. “It is well known that elderly patients require 25% to 50% less IV induction dose than younger patients,” said Shamsuddin Akhtar, MD, associate professor of anesthesiology and director of medical studies at Yale University School of

see perioperative page 32

see geriatric page 62

Games of the Clothes-Minded Robert E. Johnstone, MD

he Association of Operating Room Nurses (AORN) recently published updated recommendations for operating room (OR) attire,1 causing managers to promulgate new rules, nurses to complain, doctors to rebel and everyone to play a new round of the clothing games. Because rules for attire are based on expert beliefs, not scientific studies, anyone who Robert E. Johnstone, MD wears scrubs can declare their expertise

and play in order to demonstrate their sartorial savvy, supervisor scorn or suckk up subservience. One current battle involves disposable bouffant hats, a favorite of rule makers. A puffed-out bouffant worn over the ears covers hair better than a paper surgical cap tied behind the head, but does it make any difference in patient outcomes or worker safety? Who knows? There are no good studies. Rule makers claim the need to see clothes-minded page 8

see page 82

10th annual Anesthesiology News Special Edition Accompanies this issue

COMMENTARY

Selected reader comments from AnesthesiologyNews.com.

TECHNOLOGY

Reports on safe tubing procedures and needleless IV connectors.

PRN

The history of the search for pain relief.

CLINICAL ANESTHESIOLOGY

Hydroxyethyl starch linked to acute kidney injury in liver transplantations.

CME: PREANESTHETIC ASSESSMENT

Lesson 312: Assessment and Management of the Patient With Atrial Fibrillation for Ablation

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POLICY & MANAGEMENT

A pharmacy audit finds a discrepancy in anesthesia drug use.

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OCTOBER 2014

DIGITAL

Web Tracker Read the five most-viewed articles last month on AnesthesiologyNews.com 1.

Eye Color a Potential Cue to Pain Tolerance

Anesthesiologists Continue to Cope With Shortages of Needed Medications

Peri-op Protocols Enhancing Recovery After Colorectal Surgery

Case of Large-Scale Opioid Diversion Puts Hospitals on Alert

Surgical Management of the Failed Airway: A Guide to Percutaneous Cricothyrotomy (Educational Review)

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Click on Thiss

The American Chronic Pain Association’s Public Service Announcement The T ACPA has created a video promoting the safe use of opioid therapy: “Drugs can help control your pain, but it’s up to you to control your drugs. Because isn’t there enough pain already?” Video is here: http://www.theacpa.org/Opioid-Safety-Public-Service-Announcement

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Is IV Ibuprofen the Missing Piece to Your Surgical Pain Management Puzzle?

BRIEF SUMMARY OF PRESCRIBING INFORMATION CALDOLOR ® (ibuprofen) Injection WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS Cardiovascular Risk • Non-steroidal anti-inflammatory drugs (NSAIDs) may increase the risk of serious cardiovascular (CV) thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk [see Warnings and Precautions (5.1)]. • Caldolor is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery [see Contraindications (4.3) and Warnings and Precautions (5.1)]. Gastrointestinal Risk • NSAIDs increase the risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events [see Warnings and Precautions (5.2)]. 1 INDICATIONS AND USAGE: 1.1 Analgesia (Pain): Caldolor is indicated in adults for the management of mild to moderate pain and the management of moderate to severe pain as an adjunct to opioid analgesics. 1.2 Antipyretic (Fever): Caldolor is indicated for the reduction of fever in adults. 4 CONTRAINDICATIONS 4.1 HYPERSENSITIVITY: Caldolor is contraindicated in patients with known hypersensitivity (e.g., anaphylactoid reactions and serious skin reactions) to ibuprofen [see Warnings and Precautions (5.7, 5.8)]. 4.2 ASTHMA AND ALLERGIC REACTIONS: Caldolor is contraindicated in patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal anaphylactic-like reactions to NSAIDs have been reported in such patients [see Warnings and Precautions (5.7, 5.12)]. 4.3 CORONARY ARTERY BYPASS GRAFT (CABG): Caldolor is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery [see Warnings and Precautions (5.1)]. 5 WARNINGS AND PRECAUTIONS: 5.1 Cardiovascular Thrombotic Events: Clinical trials of several COX-2 selective and nonselective NSAIDs of up to three years duration have shown an increased risk of serious cardiovascular (CV) thrombotic events, myocardial infarction and stroke, which can be fatal. All NSAIDs, both COX-2 selective and nonselective, may have a similar risk. Patients with known CV disease or risk factors for CV disease may be at greater risk. To minimize the potential risk for an adverse CV event in patients treated with an NSAID, use the lowest effective dose for the shortest duration possible. Physicians and patients should remain alert for the development of such events, even in the absence of previous CV symptoms. Patients should be informed about the signs and/or symptoms of serious CV events and the steps to take if they occur. Two large, controlled clinical trials of a COX-2 selective NSAID for the treatment of pain in the first 10-14 days following CABG surgery found an increased incidence of myocardial infarction and stroke [see Contraindications (4.3)]. There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID use. The concurrent use of aspirin and an NSAID does increase the risk of serious gastrointestinal (GI) events [see Warnings and Precautions (5.2)]. 5.2 Gastrointestinal Effects: Risk of Ulceration, Bleeding, and Perforation: NSAIDs, including ibuprofen, can cause serious GI adverse events including inflammation, bleeding, ulceration, and perforation of the stomach, small intestine, or large intestine, which can be fatal. These serious adverse events can occur at any time, with or without warning symptoms, in patients treated with NSAIDs. Only one in five patients who develop a serious upper GI adverse event on NSAID therapy is symptomatic. Upper GI ulcers, gross bleeding, or perforation caused by NSAIDs occur in approximately

1% of patients treated for 3-6 months and in about 2-4% of patients treated for one year. These trends continue ysis (TEN), which can be fatal. These serious events may occur without warning. Inform patients about the signs with longer duration of use, increasing the likelihood of developing a serious GI event at some time during the and symptoms of serious skin manifestations, and to discontinue Caldolor at the first appearance of skin rash course of therapy. However, even short-term therapy is not without risk. Prescribe NSAIDs, including Caldolor, or any other sign of hypersensitivity. 5.9 Pregnancy: Starting at 30 weeks gestation, Caldolor, and other NSAIDs, with extreme caution in those with a prior history of ulcer disease or GI bleeding. Patients with a prior history should be avoided by pregnant women as premature closure of the ductus arteriosus in the fetus may occur [see of peptic ulcer disease and/or GI bleeding who use NSAIDs have a greater than 10-fold increased risk for devel- Use in Specific Populations (8.1)]. 5.10 Masking Inflammation and Fever: The pharmacological activity of oping a GI bleed compared to treated patients with neither of these risk factors. Other factors that increase the ibuprofen in reducing fever and inflammation may diminish the utility of these diagnostic signs in detecting risk of GI bleeding in patients treated with NSAIDs include concomitant use of oral corticosteroids or anticoag- complications of presumed noninfectious, painful conditions. 5.11 Hematological Effects: Caldolor must be ulants, longer duration of NSAID therapy, smoking, use of alcohol, older age, and poor general health status. Most diluted prior to use. Infusion of the drug product without dilution can cause hemolysis [see Dosage and reports of spontaneous fatal GI events are in elderly or debilitated patients, and therefore special care should be Administration (2.3)]. Anemia may occur in patients receiving NSAIDs, including ibuprofen. This may be due to taken in treating this population. To minimize the potential risk for an adverse GI event in patients treated with fluid retention, occult or gross GI blood loss, or an incompletely described effect on erythropoiesis. In patients an NSAID, use the lowest effective dose for the shortest possible duration. Patients and physicians should remain on long-term treatment with NSAIDs, including ibuprofen, check hemoglobin or hematocrit if they exhibit any alert for signs and symptoms of GI ulcerations and bleeding during NSAID therapy and promptly initiate addi- signs or symptoms of anemia or blood loss. NSAIDs inhibit platelet aggregation and have been shown to protional evaluation and treatment if a serious GI event is suspected. This should include discontinuation of the long bleeding time in some patients. Unlike aspirin, their effects on platelet function are less severe quantitatively, NSAID until a serious GI adverse event is ruled out. For high-risk patients, alternate therapies that do not involve of shorter duration, and reversible. Carefully monitor patients who may be adversely affected by alterations in NSAIDs should be considered. 5.3 Hepatic Effects: Borderline elevations of one or more liver tests may occur platelet function, such as those with coagulation disorders or patients receiving anticoagulants. 5.12 Pre-existing in up to 15% of patients taking NSAIDs, including ibuprofen. These laboratory abnormalities may progress, may Asthma: Patients with asthma may have aspirin-sensitive asthma. The use of aspirin in patients with aspirinremain unchanged, or may be transient with continuing therapy. Notable elevations of ALT or AST (approxi- sensitive asthma has been associated with severe bronchospasm, which can be fatal. Since cross-reactivity mately three or more times the upper limit of normal) have been reported in approximately 1% of patients in clin- between aspirin and NSAIDs has been reported in such aspirin-sensitive patients, including bronchospasm, ical trials with NSAIDs. In addition, rare cases of severe hepatic reactions have been reported, including jaundice, Caldolor is contraindicated in patients with this form of aspirin sensitivity and should be used with caution in all fulminant hepatitis, liver necrosis and hepatic failure, some with fatal outcomes. A patient with symptoms and/or patients with pre-existing asthma. 5.13 Ophthalmological Effects: Blurred or diminished vision, scotomata, and signs suggesting liver dysfunction, or with abnormal liver test values, should be evaluated for evidence of the changes in color vision have been reported with oral ibuprofen. Discontinue ibuprofen if a patient develops such development of a more severe hepatic reaction while on therapy with ibuprofen. If clinical signs and symptoms con- complaints, and refer the patient for an ophthalmologic examination that includes central visual fields and color sistent with liver disease develop, or if systemic manifestations occur (e.g., eosinophilia, rash, etc.), ibuprofen vision testing. 5.14 Aseptic Meningitis: Aseptic meningitis with fever and coma has been observed in patients should be discontinued. 5.4 Hypertension: NSAIDs, including ibuprofen, can lead to onset of new hyper- on oral ibuprofen therapy. Although it is probably more likely to occur in patients with systemic lupus erythetension or worsening of pre-existing hypertension, either of which may contribute to the increased incidence of matosus and related connective tissue diseases, it has been reported in patients who do not have underlying CV events. Use NSAIDs, including ibuprofen, with caution in patients with hypertension. Monitor blood pressure chronic disease. If signs or symptoms of meningitis develop in a patient on ibuprofen, give consideration to closely during the initiation of NSAID treatment and throughout the course of therapy. Patients taking ACE whether or not the signs or symptoms are related to ibuprofen therapy. 5.15 Monitoring: Because serious GI tract inhibitors, thiazides, or loop diuretics may have impaired response to these therapies when taking NSAIDs. ulcerations and bleeding can occur without warning symptoms, physicians should monitor for signs or symptoms 5.5 Congestive Heart Failure and Edema: Fluid retention and edema have been observed in some patients tak- of GI bleeding. Patients on long-term treatment with NSAIDs should have CBC and chemistry profiles checked ing NSAIDs. Use Caldolor with caution in patients with fluid retention or heart failure. 5.6 Renal Effects: Use cau- periodically. If clinical signs and symptoms consistent with liver or renal disease develop, systemic manifestation when initiating treatment with Caldolor in patients with considerable dehydration. Long-term administration tions occur (e.g., eosinophilia, rash), or abnormal liver tests persist or worsen, discontinue Caldolor. of NSAIDs has resulted in renal papillary necrosis and other renal injury. Renal toxicity has also been seen in 6 ADVERSE REACTIONS: The following serious adverse reactions are discussed elsewhere in the labeling: patients in whom renal prostaglandins have a compensatory role in the maintenance of renal perfusion. In these • Cardiovascular thrombotic events [see Boxed Warning and Warnings and Precautions (5.1)] patients, administration of an NSAID may cause a dose dependent reduction in prostaglandin formation and, sec- • Gastrointestinal effects [see Boxed Warning and Warnings and Precautions (5.2)] ondarily, in renal blood flow, which may precipitate overt renal decompensation. Patients at greatest risk of this • Hepatic effects [see Warnings and Precautions (5.3)] reaction are those with impaired renal function, heart failure, liver dysfunction, those taking diuretics or ACE • Hypertension [see Warnings and Precautions (5.4)] inhibitors, and the elderly. Discontinuation of NSAID therapy is usually followed by recovery to the pretreatment • Congestive heart failure and edema [see Warnings and Precautions (5.5)] state. No information is available from controlled clinical studies regarding the use of Caldolor in patients with • Renal effects [see Warnings and Precautions (5.6)] advanced renal disease. If Caldolor therapy must be initiated in patients with advanced renal disease, closely mon- • Anaphylactoid reactions [see Warnings and Precautions (5.7)] itor the patient’s renal function. 5.7 Anaphylactoid Reactions: As with other NSAIDs, anaphylactoid reactions • Serious skin reactions [see Warnings and Precautions (5.8)] may occur in patients without known prior exposure to ibuprofen. Caldolor is contraindicated in patients with The most common adverse reactions reported in clinical studies are nausea, flatulence, vomiting, and headache. the aspirin triad. This symptom complex typically occurs in asthmatic patients who experience rhinitis with or The most common reason for discontinuation due to adverse events in controlled trials of Caldolor is pruritus (<1%). without nasal polyps, or who exhibit severe, potentially fatal bronchospasm after taking aspirin or other NSAIDs 6.1 Clinical Studies Experience: Because clinical trials are conducted under widely varying conditions, adverse [see Contraindications (4.2)]. 5.8 Serious Skin Reactions: NSAIDs, including ibuprofen, can cause serious skin reaction rates observed in the clinical trials of a drug cannot be compared directly to rates in the clinical trials of adverse reactions such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrol- another drug and may not reflect the rates observed in practice. During clinical development, 560 patients were

• Caldolor reduces surgical pain1,2,3 • Caldolor can be used prior to surgery1 • Caldolor reduces narcotic consumption1 • Caldolor offers an Anti-Inﬂammatory action3

> Caldolor offers New Price Assurance Program For more information, please contact Caldolor@CumberlandPharma.com

Caldolor is indicated in adults for the management of:3 • Mild to moderate pain • Moderate to severe pain as an adjunct to opioid analgesics • Reduction of fever • Caldolor must be diluted prior to use. Infusion of the drug product without dilution can cause hemolysis.3 • The most common adverse reactions are nausea, ﬂatulence, vomiting, headache, hemorrhage, and dizziness (>5%).3 1. Singla N, Rock A, Pavliv L. Pain Med. 2010; 11: 1284-93. 2. Data on ﬁle, Cumberland Pharmaceuticals Inc. Nashville, TN. 3. Prescribing Information for Caldolor, 2014. Cumberland Pharmaceuticals Inc. Nashville, TN.

See full Prescribing Information including Boxed Warning at www.Caldolor.com exposed to Caldolor, 438 in pain and 122 with fever. In the pain studies, Caldolor was started intra-operatively and administered at a dose of 400 mg or 800 mg every six hours for up to three days. In the fever studies, Caldolor was administered at doses of 100 mg, 200 mg, or 400 mg every four or six hours for up to 3 days. The most frequent type of adverse reaction occurring with oral ibuprofen is gastrointestinal. Pain Studies: The incidence rates of adverse reactions listed in the following table were derived from multi-center, controlled clinical studies in post-operative patients comparing Caldolor to placebo in patients also receiving morphine as needed for post-operative pain. Table 1: Post-operative Patients with Adverse Reactions Observed in ≥ 3% of Patients in any Caldolor Treatment Group in Pain Studies* Caldolor 400 mg 800 mg Placebo Event (N=134) (N=304) (N=287) Any Reaction 118 (88%) 260 (86%) 258 (90%) Nausea 77 (57%) 161 (53%) 179 (62%) Vomiting 30 (22%) 46 (15%) 50 (17%) Flatulence 10 (7%) 49 (16%) 44 (15%) Headache 12 (9%) 35 (12%) 31 (11%) Hemorrhage 13 (10%) 13 (4%) 16 (6%) Dizziness 8 (6%) 13 (4%) 5 (2%) Edema peripheral 1 (<1%) 9 (3%) 4 (1%) Urinary retention 7 (5%) 10 (3%) 10 (3%) Anemia 5 (4%) 7 (2%) 6 (2%) Decreased hemoglobin 4 (3%) 6 (2%) 3 (1%) Dyspepsia 6 (4%) 4 (1%) 2 (<1%) 4 (3%) 4 (1%) 4 (1%) Wound hemorrhage Abdominal discomfort 4 (3%) 2 (<1%) 0 Cough 4 (3%) 2 (<1%) 1 (<1%) Hypokalemia 5 (4%) 3 (<1%) 8 (3%) * All patients received concomitant morphine during these studies. Fever Studies: Fever studies were conducted in febrile hospitalized patients with malaria and febrile hospitalized patients with varying causes of fever. In hospitalized febrile patients with malaria, the adverse reactions observed in at least two Caldolor-treated patients included abdominal pain and nasal congestion. In hospitalized febrile patients (all causes), adverse reactions observed in more than two patients in any given treatment group are presented in the table below.

Table 2: Patients with Adverse Reactions Observed in ≥ 3% of Patients in any Caldolor Treatment Group in All-Cause Fever Study Caldolor 100 mg 200 mg 400 mg Placebo Event N=30 N=30 N=31 N=28 Any Reaction 27 (87%) 25 (83%) 23 (74%) 25 (89%) Anemia 5 (17%) 6 (20%) 11 (36%) 4 (14%) Eosinophilia 7 (23%) 7 (23%) 8 (26%) 7 (25%) Hypokalemia 4 (13%) 4 (13%) 6 (19%) 5 (18%) Hypoproteinemia 3 (10%) 0 4 (13%) 2 (7%) Neutropenia 2 (7%) 2 (7%) 4 (13%) 2 (7%) Blood urea increased 0 0 3 (10%) 0 Hypernatremia 2 (7%) 0 3 (10%) 0 Hypertension 0 0 3 (10%) 0 Hypoalbuminemi 3 (10%) 1 (3%) 3 (10%) 1 (4%) Hypotension 0 2 (7%) 3 (10%) 1 (4%) Diarrhea 3 (10%) 3 (10%) 2 (7%) 2 (7%) Pneumonia bacterial 3 (10%) 1 (3%) 2 (7%) 0 Blood LDH increased 3 (10%) 2 (7%) 1 (3%) 1 (4%) Thrombocythemia 3 (10%) 2 (7%) 1 (3%) 0 Bacteremia 4 (13%) 0 0 0 7 DRUG INTERACTIONS: 7.1 Aspirin: When ibuprofen is administered with aspirin, ibuprofen’s protein binding is reduced, although the clearance of free ibuprofen is not altered. The clinical significance of this interaction is not known; however, as with other NSAIDs, concomitant administration of Caldolor and aspirin is not generally recommended because of the potential for increased adverse effects. 7.2 Anticoagulants: The effects of warfarin and NSAIDs on GI bleeding are synergistic, such that the users of both drugs together have a higher risk of serious GI bleeding than users of either drug alone [see Warnings and Precautions (5.2)]. 7.3 ACE Inhibitors: NSAIDs may diminish the antihypertensive effect of ACE inhibitors. This interaction should be given consideration in patients taking NSAIDs concomitantly with ACE inhibitors. 7.4 Diuretics: Clinical studies and postmarketing observations have shown that ibuprofen can reduce the natriuretic effects of furosemide and thiazides in some patients. This response has been attributed to inhibition of renal prostaglandin synthesis. During concomitant therapy with NSAIDs, observe patients closely for signs of renal failure, as well as to assure diuretic efficacy [see Warnings and Precautions (5.6)]. 7.5 Lithium: NSAIDs have produced elevations of plasma lithium levels and a reduction in renal lithium clearance. The mean minimum lithium concentration increased 15%, and the renal clearance of lithium decreased by 20%. This effect has been attributed to inhibition of renal prostaglandin synthesis by the NSAID. Thus, when NSAIDs and lithium are administered concurrently, observe patients carefully for signs of lithium toxicity. 7.6 Methotrexate: NSAIDs have been reported to competitively inhibit methotrexate accumulation in rabbit kidney slices. This indicates that NSAIDs may enhance the toxicity of methotrexate. Use caution when NSAIDs are administered concomitantly with methotrexate. 7.7 H-2 Antagonists: In studies of human volunteers, co-administration of cimetidine or ranitidine with ibuprofen had no substantive effect on ibuprofen serum concentrations. 8 USE IN SPECIFIC POPULATIONS: 8.1 Pregnancy: Teratogenic effects - Pregnancy Category C prior to 30 weeks gestation; Category D starting at 30 weeks gestation. Starting at 30 weeks gestation, Caldolor, and other NSAIDs, should be avoided by pregnant women as premature closure of the ductus arteriosus in the fetus may

occur. Caldolor can cause fetal harm when administered to a pregnant woman starting at 30 weeks gestation. There are no adequate, well-controlled studies in pregnant women. Prior to 30 weeks gestation, Caldolor should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Reproductive studies conducted in rats and rabbits have not demonstrated evidence of developmental abnormalities. 8.2 Labor and Delivery: The effects of Caldolor on labor and delivery in pregnant women are unknown. In rat studies, maternal exposure to NSAIDs, as with other drugs known to inhibit prostaglandin synthesis, increased the incidence of dystocia and delayed parturition, and decreased pup survival. 8.3 Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Caldolor, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother. 8.4 Pediatric Use: Safety and effectiveness of Caldolor for management of pain and reduction of fever has not been established in pediatric patients below the age of 17 years. 8.5 Geriatric Use: Clinical studies of Caldolor did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Elderly patients are at increased risk for serious GI adverse events. 10 OVERDOSAGE: The following signs and symptoms have occurred in individuals following an overdose of oral ibuprofen: abdominal pain, nausea, vomiting, drowsiness, and dizziness. There are no specific measures to treat acute overdosage with Caldolor. There is no known antidote to ibuprofen. In case of an overdosage, discontinue Caldolor therapy and consider contacting a regional poison control center at 1-800-222-1222. Manufactured for: Cumberland Pharmaceuticals Inc., Nashville, TN 37203 US Patent Number 6,727,286

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Rule makers claim the need to prevent infections empowers them to try different things and make everyone in the OR look like identical dweebs.

prevent infections empowers them to try different things and make everyone in the OR look like identical dweebs. Many anesthesiologists like the tighter fit and feel of surgical caps and feel awkward in the puffy pate pullovers, so they rebel, actively or passively, and play the clothes game. Some anesthesiologists like to wear surgical caps made from cloth with college, sports or military logos on them, personal statements of their past affiliations or present interests, building camaraderie among OR teams. Rule pooh-bahs disdain such individual behavior, and demand daily disposal or washing of these hats. Then, in a deft Catch-22 move, they ruled out home laundering, citing the new AORN recommendations. In a recent online comment and response on cloth surgical caps, one nurse complained, “AORN can supply NO evidence-based research/studies that prove wearing home-laundered scrubs increases the incidence of surgical site infections.” An administrator responded, “(You are) falling into the trap of evidencebased practice. Because evidence-based practice does not exist on a behavior is not justification to engage in the practice.”2 I translate this as “wear it because I said so.” Players might note that the evidence that does exist generally shows no difference in microbial populations among facility-laundered, third-party–laundered or single-use scrubs.3 So why are there no OR clothing outcome studies? Actually there are a few, but they generally show no improvements with surgical outfits, not even facemasks. Tunevall, in a study of 3,088 patients undergoing general surgery, found a reduced rate of wound infections when surgeons operated without masks.4 In a recent “Expert Guidance,” the Society for Healthcare Epidemiology of America stated, “Healthcare personnel attire is an aspect of the medical profession steeped in culture and tradition. The

role of attire in cross-transmission remains poorly established, and until more definitive information exists priority should be placed on evidence-based measures to prevent healthcare-associated infections.” Good luck with citing evidence to clothes-minded OR managers. Many sit in suite offices hoping for quarterly performance and expense reports that qualify them for bonuses. Issuing clothing rules proves they are managing. Buying patient gowns without arm snaps or scrub shirts without pockets can save five cents apiece, enough in aggregate to fund bonuses. If doctors and nurses do not like OR manager rules, at least the scrub-maskk and-bootie salespeople do. Stamping out personal styles, comfort and fun among workers and patients is just collateral damage. OR clothing games started decades ago. When institutions developed surgical suites in the 1950s and 1960s, managers asked everyone to wear institutional scrub clothes. Surgeons then demanded their own lounges and lockers to change into these scrubs. Tit-for-tat demands continued until someone warned that static electricity in the OR could ignite flammable anesthetics and he would have to inspect nurses for silk underwear, a known cause of sparks. This titfor-tat response caused managers to ban all flammable agents, and end that round of clothing games. Eventually, the public associated scrub clothes with surgeons and anesthesiologists, so young men started wearing scrubs outside hospitals, around campuses, to parties, hoping to attract young women. “I am wearing scrub clothes because I am studying brain surgery—would you like to have a drink with me?” became a successful pickk up line. The enormous loss of scrub clothes from hospital inventories led administrators to lock them up, dispense them like narcotics, color them ugly or ban their wear outside the OR. The commanding general at one U.S. Army hospital who saw his expenses for scrubs approach that

for pills, ordered the military police to arrest anyone wearing scrubs outside the hospital, one of the few clothing rules that has worked. Another current clothing battle pits the thinblooded who wear surgical jackets in cold ORs against the bare-arms people who think jacket sleeves transport germs to patients. Each justifies his or her preference on preventing infections, without any real data. Similarly, the need to wear hospital name badges pits retractable-cord zealots against lanyard devotees. Cord people claim lanyards are unsafe because they can hang into a wound. One lanyard player inspected the retractable cord of an adversary and let it snap back into the face of the wearer, demonstrating its unsafeness, playing that game to a draw. Footwear is another favorite area for rules. Some suites mandate shoe covers, whereas others don’t stock them, expecting everyone to provide suitable OR shoes. And the rules about which shoes are suitable are lengthy and diverse. Anesthesiologists who work in multiple institutions often observe different rules, without apparent differences in infection rates, personal safety or any other outcome. So workers rebel and mock whimsical rule makers. Some wear one of each style hat on their heads, some find individuality with rigid compliance. After one rule maker harangued and annoyed staff to minimize waste and save money, signs appeared in the surgical lounge to conserve toilet paper by using both sides. Players should understand the why’s and who’s of clothing rules and makers, and understand everything is ultimately about teams delivering good patient care. A pain doctor recently lost his medical license for not wearing a facemask when performing an epidural injection. He had to get a court order to overturn the suspension. The Centers for Disease Control and Prevention estimated there are 157,500 surgical site infections per year in the United States, a huge burden for patients and health care costs. Perhaps anything that could reduce these infections is worth trying. But most infections relate to preexisting patient conditions, such as peripheral vascular disease and diabetes, or missed evidence-based medical practices, such as chlorhexidine skin preps and timely antibiotic prophylaxis, not to the color, texture or style of surgical attire. Managers trying to remove comfort and individuality from OR attire without supporting evidence are likely to find themselves the subject of gamesmanship. Maybe as an alternative, we could all demand well-done clothing studies? Dr. Johnstone is professor of anesthesiology at West Virginia University in Morgantown, and a frequent contributor to Anesthesiology News. This commentary represents his personal opinion.

References 1. Recommended practices for surgical attire. In: Perioperative Standards and Recommended Practices. Denver, CO: AORN; 2014. 2. www.outpatientsurgery.net/discussions/85/Cloth-surgical-caps. Accessed September 3, 2014. 3. Twomey CL, Beitz H, Johnson HB. Bacterial contamination of surgical scrubs and laundering mechanisms: Infection control implications. Infection Control Today, y October 19, 2009. www.infectioncontroltoday.com. Accessed September 3, 2014. 4. Tunevall TG. Postoperative wound infections and surgical face masks: a controlled study. World J Surg. 1991;15:383-387.

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Reader Comments and Feedback on AnesthesiologyNews.com

e are always interested in what our readers are thinking, and we actively encourage them to get in touch with us to offer opinions, story ideas and leads to potential stories. We also avidly read the comments that our viewers put on our website at AnesthesiologyNews.com. Your comments mean a lot to us, and we’re always happy to hear from

you. Here’s a snapshot of some website comments that got our attention over this past year (plus one from 2013). You can also join in the conversation via Twitter @anesthesianews and Facebook at facebook. com/ anesthesiologynews. No Laughing Matter The American Board of Pediatrics

(ABP) sent animated cartoon messages during the summer to remind physicians to complete their maintenance of certification (MOC).1 The ABP wrote the following on its Facebook page: “We’ve created three MOC videos explaining requirements. The content in these videos may not pertain to every diplomate (so be sure to check your ABP Portfolio for YOUR specific

requirement needs), but we hope you get a giggle to lighten your day.” However, many physicians did not find the cartoons amusing, and criticized the ABP for forcing the adoption of MOC requirements. From Jona5, who wrote: “MOC is increasingly being exposed as mainly a play for power and money by the various specialty boards. The actual procedures and exams have become less and less connected to real clinical practice. Why should a subspecialist continue to be tested in general areas on practice they do not engage in? In this era of evidence-based medicine, where is the independent evidence that MOC actually improves patient outcomes?” Long Wait Times Hamper SCS Success A study suggested that current wait times from pain onset to implantation reduces the long-term success of spinal cord stimulation (SCS) therapy.2 Educating patients and physicians on the benefits of SCS might streamline the process. Researchers found that the average wait period was 5.12 years, with the first physician contact taking place a mean of 3.4 months after pain onset. They also found that the nonimplanting anesthesiologist took the longest to refer patients to implantations, whereas neurosurgeons were the quickest. From dcheu, who wrote: “We need to be careful in assuming that increased use of SCS treatment is a desired result. This article seems to imply this notion. As in any treatment modality, it has a role but can be overused. A great study would be to see if increased use of SCS results in better overall outcomes. Unfortunately, this study only seems to reinforce the universal notion that you can just follow the money.” General Anesthesia Linked to Mortality in Stroke Patients Researchers found significantly greater mortality rates among patients with acute ischemic stroke who received general anesthesia versus conscious sedation (40% vs. 22%; P<0.05).3 The mortality rate for ischemic stroke in patients presenting for first-time stroke is 16%, according to the researchers. They analyzed the records of 109 patients who underwent endovascular intervention therapy between December 2006 and October 2012; 35 received general anesthesia, 74 received conscious sedation. A regression

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COMMENTARY analysis demonstrated that two of the significant predictors for mortality in the model were anesthesia type (odds ratio [OR], 2.692; 95% confidence interval [CI], 1.036-6.996; P=0.042) and post-procedure glucose level (OR, 1.104; 95% CI, 1.003-1.024; P=0.011). The method of anesthesia did not have a significant effect on patients’ functional independence level at discharge. From mharp, who wrote: “I wonder how many stroke patients will be able to lie still and be cooperative with conscious sedation. And, since conscious sedation doesn’t require an anesthesiologist or CRNA, perhaps the surgeries could be managed by an RN or technician. Can you see surgeons liking this?” Inadequate Sedation And Analgesia Patients who underwent rapidsequence intubation (RSI) at the University of California, San Francisco’s emergency department (ED) between 2008 and 2012 did not receive the appropriate sedation and analgesia, according to an analysis of 499 patient records.4 The investigators found that 55.7% (278 of 499) did not receive post-RSI analgesia and 25.7% (128 of 499) were not given sedatives during their stay in the ED. From joana, who wrote: “Hard to believe that MDs in ED don’t know that muscle relaxants are not sedatives! I have also heard that some ICUs use muscle relaxants without sedatives. There is no excuse for this and the survey is extremely worrying with regard to quality of care!” Keeping the ‘MD-Led Care’ in ‘Team’ Robert E. Johnstone, MD, examined the need for team leaders in anesthesiology.5 Dr. Johnstone, professor of anesthesiology at West Virginia University in Morgantown, said “studies of teams and their qualities all seem to assume someone is leading them.” He also looks at how the word “team” has been defined in the anesthesiology world, and how it can affect health care workers and patient care. An excerpt from richa, who wrote: “All teams need leaders and leadership needs to be found at different levels. MDs are at the top of that leadership but RNs and CRNAs [certified registered nurse anesthetists] also have leadership roles to play in their own way. It is important that everyone knows and appreciates their role in creating safe and effective health care. Hierarchy isn’t a bad thing as long as there is respect in both directions and

hierarchy doesn’t preclude teamwork but rather fosters it.” Skullcap Ban Lauren A. Kosinski, MD, MS, assistant professor of surgery at the Medical College of Wisconsin, in Milwaukee, examined the ban on surgeon’s caps or skullcaps following a survey from the Centers for Medicare & Medicaid Services.6 Under the new mandate, surgeons would have to use disposable bouffant caps issued by the hospital.

Some surgeons were outraged because References they believe skullcaps help to distinguish 1. Med board uses humor—lamely, critics say—to pitch certification maintenance. Anesthesiology them and they did not agree with the News. 2014;40(9). reasoning for the mandate. From port, who wrote: “Does it 2. Researchers suggest ways to reduce SCS wait times. Anesthesiology News. 2014;40(6). make a real difference? No, but it 3. General anesthesia linked to mortality in stroke would burn me too. When are these patients. Anesthesiology News. 2014;40(7). unfounded random decisions going to 4. Improved rapid-sequence intubation. Anestheaffect patients?” siology News. 2014;40(3). From wmerr, who wrote: “Not to 5. Brave new word. Anesthesiology News. 2014;40(1). mention the issue of a T-shirt under 6. CMS directives: hat or miss. Anesthesiology News. scrubs—where is the data on that edict?” 2013;38(8). —Compiled by Martin Leung

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Are Peripheral Nerve Blocks Better for Post-TKA Pain? Toronto—Peripheral nerve blocks (PNBs) following discharge after total knee arthroplasty (TKA) surgery reduce reliance on medications like opioids. Arguing against the contention that PNBs are no longer indicated for total joint replacement surgery, Colin McCartney, MBChB, associate scientist, Sunnybrook Research Institute,

Toronto, Ontario, Canada, argued that PNBs provide “profound analgesia for our patients.” Dr. McCartney, y speaking at the International Symposium of Ultrasound for Regional Anesthesia, Pain Medicine & Perioperative Applications, maintained that the impact of local infiltration anesthesia is transient and the evidence for its use is

lacking. “It has generally been compared to placebo,” said Dr. McCartney, y who is a professor in the Department of Anesthesia at the University of Toronto. A key advantage of PNBs is that they produce postoperative opioid-sparing, said Dr. McCartney, y citing a metaanalysis of randomized trials ((Anesth Analgg 2005;101:1634-1642).

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Nellcor™ Respiration Rate Technology | Microstream™ Capnography Vital Sync™ Virtual Patient Monitoring Platform Learn more about respiratory compromise, which includes respiratory insufficiency, arrest and failure, at Covidien.com/respiratorycompromise 1. Linde-Zwirble WL, Bloom JD, Mecca RS, Hansell DM. Postoperative pulmonary complications in adult elective surgery patients in the US: severity, outcomes and resources use. Crit Care Med. 2010;14: P210. 2. Agarwal SJ, Erslon MG, Bloom JD. Projected incidence and cost of respiratory failure, insufficiency and arrest in Medicare population, 2009. Abstract presented at Academy Health Congress, June 2011. 3. Wier LM, Henke R, Friedman B. Diagnostic Groups with Rapidly Increasing Costs, by Payer, 2001 -2007. Healthcare Cost and Utilization Project. Agency for Healthcare Research and Quality. Statistical Brief #91. June 2010. Available at: http://ww.hcup-us.ahrq.gov/reports/statbriefs/sb91.pdf 4. Kelley SD, Agarwal S, Parikh N, Erslon M, Morris P. Respiratory insufficiency, arrest and failure among medical patients on the general care floor. Crit Care Med. 2012;40(12):764. COVIDIEN, COVIDIEN with logo, Covidien logo and positive results for life are U.S. and internationally registered trademarks of Covidien AG. Other brands are trademarks of a Covidien company. ©2014 Covidien. 14-PM-0100a

The root problem of why PNBs are perceived as being ineffective lies in inadequate training of anesthesiologists, said Dr. McCartney. y “Our training of anesthetists to do PNBs is poor,” he said. “Doing 40 or 50 blocks in training is not sufficient.” Dr. McCartney challenged the notion that PNBs are a risk factor for postprocedure falls. He cited research published earlier this year ((Anesthesiology 2014;120:551-563) that failed to find a relationship between the use of continuous PNBs and the risk for falls after TKA. The study found TKA patients who experienced falls while in hospital were older and had more major complications, including 30-day mortality. “The bottom line is that PNBs don’t cause patients to fall,” said Dr. McCartney. y “It’s other factors, like age.” Local infiltration anesthesia is generally thought to improve postoperative rehabilitation and accelerate recovery, whereas PNBs are regarded as slowing functional recovery. But Dr. McCartneyy said continuous nerve blocks do not necessarily mean a slower functional recovery for patients. Pointing to a randomized study of patients who underwent TKA (Br J Anaesth 2010;105:185-189) that compared postoperative analgesia with either periarticular infiltration of local anesthetic or continuous femoral nerve block, Dr. McCartney said patients who received the femoral nerve block experienced better recovery than those who received periarticular infiltration. Local Infiltration Anesthesia? Effective nerve blocks should meet several criteria, said Sanjay Sinha, MD, director of regional anesthesia at St. Francis Hospital and Medical Center in Hartford, Conn., and assistant clinical professor of anesthesiology at the University of Connecticut School of Medicine, Farmington. “The ideal nerve block should be simple to perform, so simple that even surgeons can do it,” said Dr. Sinha. “It should not produce motor weakness, so ambulation can be started sooner and physiotherapy can be started sooner. The cost of doing the block should be minimal. It sounds to me like local infiltration anesthesia meets all these criteria.” One of the disadvantages of the PNB is that it demands “a higher skill see PNB page 16

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PAIN MEDICINE

Pain Specialists Show Increasing Rates of Burnout Prevention, mitigation programs needed Montreal—The high rate of burnout among pain specialists found in a recent study may be a wake-up call to the specialty, as it places these physicians at risk for substance abuse, interpersonal difficulties and suicidal tendencies, and also increases the risk for medical errors. The investigators called for preemptive measures to help pain specialists before burnout sets in. According to investigator Henry Kroll, MD, vice chairman of anesthesiology at Henry Ford Hospital, in Detroit, burnout can have wide-ranging effects in the hospital environment, influencing quality of care, job turnover and relationships with other health care professionals. In addition to determining the incidence of burnout, the study aimed to nail down the relationship, if any, between demographic and psychosocial characteristics of the job that predict burnout. To that end, Dr. Kroll and his colleagues surveyed the membership of the American Society of Interventional Pain Physicians. The survey included demographics questions, the Maslach Burnout Inventory-Human Services Survey and the Job Content Questionnaire. The Maslach assesses burnout in helping professions through three subscales: emotional exhaustion, depersonalization and personal accomplishment. The Job Content Questionnaire measures the social and psychological characteristics of jobs. “There are three major scales: decisional latitude, psychological demands at work and social support,” Dr. Kroll explained. “Most of the adverse reactions of psychological strain occur when the psychological demands are high, the workers’ decisional latitude is low and they have low social support.” As Dr. Kroll reported at the 2014 annual meeting of the International Anesthesia Research Society (abstract S-114), 266 surveys were completed between June and November 2013. It was found that on the Maslach Inventory, 61.3% (n=141) of respondents scored high in emotional exhaustion, 35.6% (n=82) scored high in depersonalization and 42.6% (n=98) had low scores for personal accomplishments—the three essential indicators of burnout. “Almost 43% of pain physicians had low personal accomplishment scores,” he said, “compared with 12% in a national sample of physicians.” The researchers also performed a

covariate analysis of possible predictors for each of these three elements. “We found that in terms of seven different covariates, job insecurity was the one across the board that significantly predicted burnout in the pain medicine physician population,” Dr. Kroll said. “There was some tendency toward

predictability, with lack of decisional authority predicting burnout. But the key area was job insecurity.” Indeed, higher levels of job insecurity predicted more emotional exhaustion, more depersonalization and less personal accomplishment. Specifically, for each one-point increase in

job insecurity, there was a 1.74-point increase in emotional exhaustion, a 1.09-point increase in depersonalization and a 1.03-point decrease in personal accomplishment. Identifying burnout and its predictors among pain medicine physicians is see burnout page 21

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Analgesics Drive Medication-Overuse Headaches

fter conducting a systematic literature review and analysis, researchers found that analgesics were associated with a significantly higher risk for medication-overuse headache (MOH) than triptans, ergotamines or opioids. Analgesic-use rates in patients with episodic migraine ranged from 22% to 54% across seven European countries,

whereas rates for triptans varied from 7.9% to 29.1% and rates for ergotamines from 3.8% to 20%. The overall prevalence of opioid use was 4.1%. The researchers, from several academic centers in the United States and Europe, as well as from Pfizer, presented their results as a poster at the American Headache Society’s 2014 annual meeting in Los Angeles (poster 1965115).

However, Elizabeth Seng, PhD, assistant professor of psychology and research assistant professor of neurology, Yeshiva University, New York City, questioned a vital set of determinations the researchers made: the rate that each of the four medications were used for episodic migraine in the seven countries where the studies were conducted. Along with “adjustment factors,” the

Interested in conducting your own research? Consider the Merck Investigator Studies Program. What is MISP? The mission statement of the Merck Investigator Studies Program (MISP) is to advance science and improve patient care by supporting, through the provision of drug/vaccine and total/partial funding, high-quality research that is initiated, designed, implemented and sponsored by external investigators. Who Can Participate? The Merck Investigator Studies Program is open to all academic and community-based physicians, anesthesiologists, surgeons, and researchers worldwide who are interested in conducting their own research. How Does the Program Work? This program consists of committees of medical and scientiﬁc staff from different therapeutic areas who meet regularly to review Merck investigator study proposals. Support and funding are provided based on the scientiﬁc merit of the proposal as well as whether it is in alignment with the published areas of interest.

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rates served as the denominator in the calculations of relative risks for MOH in the Pfizer-fundedd study. The investigators reviewed the literature to arrive at the medication-use rates, but did not cite any of the studies used to do so, nor did they indicate how they arrived at the adjustment factors. Dr. Seng, an expert in the field, said she felt the researchers appeared to “lack confidence” in their prevalence estimates. In the results section of the poster, they stated: “When we considered an 8% prevalence of opioid use (rather than 4.1%), the fixed-effect weighted average relative risk was 2.51, suggesting an average 151% increased risk for MOH with analgesics compared with opioids.”

Researchers found that analgesics were associated with a significantly higher risk for medication-overuse headache than triptans, ergotamines or opioids. “Where did they get the 4.1% prevalence of opioid use from, and why did they rerun the results with a higher prevalence of opioid use?” Dr. Seng asked. “It’s true, they did have to try to estimate prevalence due to the nature of this analysis, I just think they didn’t do the best job communicating how they estimated prevalence and how confident they were in their prevalence estimates.” In response, lead study investigator Kristian Thorlund, PhD, visiting associate professor, Stanford Prevention Research Center, Stanford University School of Medicine, Stanford, Calif., said, “Because we know opioid use is much higher in the U.S., and the included data were predominantly European, we chose an approximate doubling in medication use, of 8%, as a sensitivity analysis.” The combined estimate of the relative risk for MOH between triptans and analgesics was 0.25 (95% confidence interval, 0.22-0.28). For ergotamines versus analgesics it was 0.38 and for analgesics versus opioids it was 1.29. However, in all three comparisons there was very high heterogeneity between the studies, rendering the relative risk estimates inconclusive. —Rosemary Frei, MSc Drs. Seng and Thorlund did not report any financial conflicts of interest.

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PAIN MEDICINE

DEA Ends Investigation of Pain Doctor

n 2013, it came to light that three years earlier the Drug Enforcement Administration (DEA) had opened an investigation of thenpresident-elect of the American Academy of Pain Medicine (AAPM) Lynn Webster, MD, related to overdose deaths at Dr. Webster’s Lifetree Pain Clinic in Salt Lake City. [Editor’s note: Pain Medicine News, sister publication of Anesthesiology News, was one of the news publications that reported the story.] Recently, the U.S. Attorney for the District of Utah declined to pursue charges, effectively ending the investigation. Pain Medicine News spoke with Dr. Webster, now immediate past-president of the AAPM, about his four-year ordeal. Pain Medicine News: Dr. Webster, r thank you for speaking with us. Let’s start by asking what ran through your mind when you first found out the DEA investigation was over? Lynn Webster, MD: Relief. Not for me alone, but for my family and friends, who were supportive throughout this, and for my dedicated professional colleagues of more than 15 years, who treated a majority of the patients at the clinic during the period leading up to the DEA visit. This dark shadow hung over us for four years, and we had no way of knowing when—or even if— it would end. My attorney told me that there is usually no notice of an end to such an investigation. It can linger for the rest of your life, leaving suspicion of possible wrongdoing. I was always confident that our clinic had complied with the law and did the right thing. But, these days, that doesn’t protect anyone from an allegation of wrongdoing. So, we are thankful that a period was placed at the end of our story, allowing all of us from the clinic to move forward. PMN: You recently wrote an opinion piece on the prosecution of pain doctor Daniel Baldi, MD (Pain Medicine News, August 2014, page 1). Can you discuss how your personal situation over the past several years has shaped your interest and stance on physician prosecution? Dr. Webster: My personal experience alone doesn’t necessarily shape my view. My views are formulated by what is happening in our field to my colleagues and our patients. The pressure

to reverse the prescription drug problem has resulted in calls for stricter policies and more law enforcement. We should all be aware that there are unsavory physicians who dispense pills for profit without a legitimate medical need. Crossing the line in this manner has disrupted the ability of real doctors to treat patients with real pain when opioids are involved.

Physicians practicing in good faith who use opioids to treat some types of chronic pain face negative judgments, literally and figuratively, if a death occurs in their practice. This is unlike any other area of medicine. In some cases, the line between civil liability and criminal behavior has been blurred, in which clinical judgments retrospectively can be viewed as reckless and

with willful intent to cause harm. Even a bad outcome without evidence of error can be investigated or prosecuted criminally. Ultimately, injustices such as these pose serious threats to people with chronic pain. Today, many physicians refuse to risk treating people in pain with opioids, even in cases where other therapies have failed or would see DEA page 16

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be ineffective. A vocal contingent opposes prescribing opioids to patients with chronic pain, inexplicably unless the patients have cancer. I wish they would first listen to the stories of people who are crying for help and who have no clinically viable alternatives. It is too infrequent that policymakers, regulators, members of the press and government officials ever express concern for these people. That saddens me. PMN: Critics have called this discussion of physician prosecution a “false narrative.” What is your response to that? Dr. Webster: If you mean that it is false that there may be overreach by some regulators and prosecutors, I would say the facts state otherwise. Look at the case of Daniel Baldi, a doctor of osteopathic medicine and a pain physician in Des Moines, Iowa. He was recently charged with nine counts of involuntary manslaughter in patients who died of overdoses, complicated by multiple factors that included worsening medical conditions, medications prescribed by others and the co-ingestion of illicit drugs. In one case, Dr. Baldi had not seen the patient for months leading up to the death; in another, Dr. Baldi had only seen the patient once. However, the common denominator was that each patient had been prescribed opioids. The deaths were tragic, but the charges were unconscionable. The judge dismissed two counts, and the jury acquitted him of the rest. Regardless, Dr. Baldi’s career and finances are ruined, although it was clear in court he had practiced in good faith and did all he could to help his patients. Other physicians throughout the country are being forced into plea bargains because they can’t afford a defense. Aside from prosecution, regulators target “high prescribers” for investigation without sufficient context to evaluate the type of practice they run or the patients they treat. Actions like these clearly create a chilling effect. There is no false narrative.

the implication is that there is something fishy and the perception of wrongdoing takes root. As a physician who has treated people in pain all my professional life, I always grieved for patients we treated but died. The fact is that some Lynn Webster, MD patients at our clinic died in spite of their treatment, but not because of it. This underscores the complexity and, sadly, inability of society to address the crisis of chronic pain. As for CNN, I do not take issue with them producing a story for national consumption, but how they did it. The processes by which they collect, analyze, verify and double-checkk the facts call into question the network’s professionalism and journalistic integrity. I’ve made some of the inaccuracies in their story known to them and they’ve acknowledged this in correspondence with me. I did not participate in an interview with CNN, and I had no obligation to participate. However, that does not relieve CNN of its obligation as journalists to ensure their stories are free of error, bias and guesswork. This they did not do. PMN: You have long said opioids need to be replaced as viable treatments for pain. Where should we go from here as a society to make that happen?

Dr. Webster: This is true. It would be morally reprehensible to abandon our societal obligation to treat mankind’s primal enemy: pain. There is controversy now about how many people in America actually suffer from chronic pain. Regardless, pain is the No. 1 reason people visit a physician. It will take time, but it is imperative to find safer and more effective alternatives to opioids. Not only because of the politics surrounding opioids but because, as medications, opioids are not effective enough and cause too much harm and grief. As a country, we should invest heavily in better therapies because of the prevalence and financial cost to society of untreated pain and addicPMN: You were the subject of a CNN story by tions. We need a short-term strategy and a long-term Dr. Sanjay Gupta last year. The story centered strategy. In the near term, we must increase access around the deaths of two former patients from your to effective alternative therapies, which exist but are clinic. Do you feel vindicated given that the U.S. too seldom covered by insurers. Every time a reguAttorney declined the case? lator complains about the harm from opioids, he or she should also offer to support making available Dr. Webster: Vindication implies that I was effective alternatives. We need guaranteed minimum accused of wrongdoing. I was never accused of any insurance coverage for pain therapies. We also need wrongdoing, but when the DEA makes an inquiry, better education about the risks and benefits of all

PNB

CONTINUED FROM PAGE 12

set and is technically challenging,” said Dr. Sinha, who added that risk for infection is also a consideration with PNBs and their associated use of catheters, and that use of PNBs demands greater manpower resources. The use of local infiltration anesthesia can produce sufficient pain control for patients undergoing TKA. Dr. Sinha referred

to one study ((Acta Anaesthesiol Scand 2008;52:1331-1335) involving 12 patients who underwent bilateral TKA. Ropivacaine was administered in one knee and saline in the other, so patients served as their own controls, and patients received multimodal medications postoperatively. “They [researchers] found pain control was superior in the knee that had local anesthesia as opposed to placebo,” said Dr. Sinha.

Colleagues Comment on End Of Webster Investigation

“R

egarding the investigation into the Lifetree Pain Clinic, Dr. Webster was forthcoming in discussions with the American Academy of Pain Medicine board of directors. And although this investigation undoubtedly caused him real concern and embarrassment, he upheld his responsibilities as the Academy’s president with great conviction and professionalism. I was proud to have worked closely with him during that time, and I am very glad that the matter has been put to rest.” —Phillip A. Saigh Jr., executive director, American Academy of Pain Medicine

“W

ith this behind him, I am pleased that Dr. Webster can fully focus on his contributions to advancing research and care for people with pain. Given the significant challenges today to effectively address the challenges of these complex patients, his efforts and attention are needed without distraction.” —Steven D. Passik, PhD, pain psychologist

treatment options, not just opioids. In the long term, we need Congress to create incentives for industry to develop safer and more effective therapies. We can do better if we have the will. PMN: What do you look forward to accomplishing going forward? Dr. Webster: My mission during the four years of the investigation was the same as it has always been: to help people living with pain and to prevent opioid abuse and overdose deaths. Going forward, I plan to adhere to that core mission. I agree with the Institute of Medicine that we need a cultural transformation. Access to appropriate and safe pain treatment should be viewed as a human right—a civil liberty. I am working on a television documentary profiling the lives of people in pain, which, tentatively, is planned for national broadcast in fall 2015. I am also working on a book. It is not a book about how to treat pain or the politics of pain. It is an experiential journey with some of the people I have treated. Their stories, the documentary and efforts to promote the National Pain Strategy through the National Institutes of Health is where I will invest much of my energy for the next couple of years. Then I will see where we are. I hope it’s a better place. ■

Dr. Sinha also pointed to a metaanalysis that looked at local infiltration anesthesia directly into the knee ((J Bone Joint Surg Br 2012;94:1154-1159). The authors concluded that local infiltration produced a reduction in postoperative pain. The emergence of agents like liposomal bupivacaine may assist in prolonging postoperative analgesia and potentially decreasing use of opioids post-discharge, according to Dr. Sinha.

One of the potential risks associated with PNB is nerve damage, said Dr. Sinha. “Anytime you do a nerve block, there is a risk for nerve injury.” However, a review of 32 studies (Anesth Analgg 2007;104:965-974) found the rate of neuropathy after PNB to be 3%, but investigators found the occurrence of permanent postPNB neuropathy to be very rare. —Louise Gagnon

18 I AnesthesiologyNews.com

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PAIN MEDICINE

The following advertorial has been provided by Spacelabs Healthcare and is designed to support the advertisement presented to the right.

Side Effects From Ziconotide, Concomitant Meds Tracked

post hoc analysis indicates that concomitant use of the conotoxin ziconotide (Prialt, Jazz Pharmaceuticals) with both antidepressants and anticonvulsants increases the incidence of adverse effects such as depression, aphasia and somnolence compared with ziconotide treatment alone. However, it appears that the combination of ziconotide and antidepressants or ziconotide and anticonvulsants is associated only with a lower rate of some other side effects, such as anxiety and hallucination compared with ziconotide monotherapy. The highest mean intrathecal ziconotide daily dose was 10.8 mcg among the 57 patients taking the nonopioid analgesic and antidepressants, whereas the lowest was 5.7 mcg in the 37 individuals receiving ziconotide monotherapy. “Caution should be exercised when administering any CNS [central nervous system] depressant/active drug with a potent [intrathecal] agent like ziconotide,” said Lawrence Kamhi, MD, an interventional pain physician in private practice in Warwick, N.Y., who was not involved in the study. “But the results showed that ziconotide with antidepressant or anticonvulsant therapies is relatively safe in the doses administered in the study. It [also] was reassuring that hallucination wasn’t one of the most frequently reported side effects, since reports of these and other undesirable psychiatric side effects in some patients have made pain doctors a bit reluctant to prescribe ziconotide.” Mark Wallace, MD, one of the extension study investigators and lead author of the poster presented at the American Pain Society’s 2014 annual meeting (poster 393), said much of the reluctance to use ziconotide stems from early studies that involved much higher doses of the medication than are used today. “There also has been a suspicion that concomitant meds increase side effects, which was confirmed in this study,” said Dr. Wallace, chair, Division of Pain Medicine at the University of California, San Diego Medical Center. “This underlines the need to consider adjusting the concomitant medication doses before abandoning ziconotide if side effects occur.” The study was an analysis of patients who had completed a randomized, placebo-controlled trial or one of two open-label studies, all involving intrathecal ziconotide in the active treatment

arm. The patients had implanted SynchroMed Infusion Systems, had not experienced any infections or pump complications, and were not pregnant or lactating. Patients who had used any investigational drug except ziconotide in the 30 days leading up to the extension study were excluded. The dose of ziconotide was titrated up as needed in patients who had been on either placebo or ziconotide. Patients taking antidepressants and anticonvulsants together with ziconotide had a 42.6% rate of somnolence compared with an 18.9% rate among those on ziconotide alone. Other side effects that ziconotide patients experienced at significantly higher rates when taking both antidepressants and anticonvulsants compared with ziconotide alone were depression (23.4% vs. 8.1%), aphasia (22.3% vs. 8.1%), sweating (20.2% vs. 8.1%), hypertonia (19.1% vs. 8.1%), accidental injury (18.1% vs. 2.7%), fever (14.9% vs. 2.7%), urinary tract infection (13.8% vs. 0%) and sinusitis (10.6% vs. 0%). The combination of ziconotide and antidepressants was associated with higher rates of nausea, depression, sweating, chest pain, sinusitis and urinary retention than ziconotide monotherapy. Conversely, compared with ziconotide alone, the combination of ziconotide and antidepressants led to lower rates of hallucination, taste perversion, confusion and abdominal pain. According to the extension study results in the poster, ziconotide taken with anticonvulsants was marked by increased rates of urinary tract infection, urinary retention, accidental injury and peripheral edema compared with ziconotide monotherapy, whereas ziconotide plus anticonvulsants reduced rates of rhinitis, hallucination, anxiety, back pain and asthenia compared with ziconotide monotherapy. “I would have liked to know the doses of antidepressants and/or anticonvulsants administered, on average, in each group of patients because we sometimes titrate anticonvulsant agents to effect/ side effects seen,” Dr. Kamhii said. Jazz Pharmaceuticals officials said the company has not analyzed the dosing information. —Rosemary Frei, MSc Dr. Wallace is a consultant and on the speakers’ bureau for Jazz Pharmaceuticals. Dr. Kamhi did not report any relevant conflicts of interest. The study was funded by Jazz Pharmaceuticals.

Q. Who is Spacelabs Healthcare? A. Spacelabs Healthcare is a comprehensive perioperative solutions provider developing, manufacturing and distributing medical equipment and services throughout the world. We provide solutions for patient monitoring and connectivity, anesthesia delivery and ventilation, diagnostic cardiology, and supplies and accessories, selling to hospitals, clinics and physician offices. Spacelabs’ world headquarters is in Snoqualmie, Washington, where we develop and assemble anesthesia, patient monitoring and cardiology products. Spacelabs provides various perioperative solutions from low to high acuity, covering simple to complex cases and pediatric to geriatric patients—offering you the choices you need in anesthesia delivery, patient monitoring, and supplies and accessories. What’s more, you can configure solutions to satisfy your individual practices and preferences. Our product line is continually developing and expanding with new platforms and technologies. Spacelabs Healthcare has more than 50 years of innovation and service and began as the innovator of life support systems for the Gemini and Apollo space missions. Always endeavoring to meet our customer’s unmet needs, the result is the complete rethinking of the anesthesia delivery system experience.

Welcome to ARKON. Until today, anesthesia delivery systems were designed with functionality and reliability as the priority. While important, we saw these as our starting point. ARKONTM is our “evolutionary” anesthesia delivery system that pushes the boundaries to provide advanced flexibility and ergonomics for you, the people who use these machines. ARKON puts your patient front and center – offering anesthesiologists the maximum in functionality, comfort and control. Through a combination of an expandable clinical console, which extends out to enable a wide-angle view of your clinical setting, and enhancements not previously available in the perioperative environment, we focused ARKON on you so you can focus on your patient. While other machines concentrate only on the technology of anesthesia delivery, we believe you will find ARKON unique in its attention to the details of how you work. Providing you with an improved workplace was our priority, with flexibility our focus. Designed to improve the user experience, ARKON is part of our mission to inspire the world to bring the best care to patients as well as their families.

Q. Does Spacelabs Healthcare collaborate with clinicians to provide clinically relevant products? A. Spacelabs Healthcare values the strong clinical partnerships that we have developed and maintained over the past half-century. Through continuous and effective communication with clinical user groups, we gather a deep understanding of needs and requirements in order to develop solutions to help clinicians achieve their goals. Always a leader in innovation with Accessibility, Continuity and Partnership, Spacelabs Healthcare delivers on our promises to: • Help improve patient care. • Help clinicians achieve their goals. • Demonstrate honesty, reliability and integrity. • Deliver quality products and services.

Q. Is Spacelabs Healthcare known for excellence in customer service? A. At Spacelabs Healthcare, excellence in customer service and support are not just words but they are values embraced by all our employees, which shape the way that we do business. As a result, IMV ServiceTrak™, one of the most respected surveys in the health care industry, ranked Spacelabs as a Top Rated Manufacturer for Overall Manufacturer Performance, Competence of Install Team, Overall OEM Training Program, Overall Phone Support and Overall Service Engineer Performance in the past year. When selecting a perioperative solutions company, consider Spacelabs’ experience and heritage of innovative and intuitive products developed in partnership with our customers to address real-life clinical needs. Our Customer-first philosophy reflects our commitment to superior care for you and your patients as well as product support by our award-winning service team.

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20 I AnesthesiologyNews.com

OCTOBER 2014

PAIN MEDICINE

Wait Times for Spinal Cord Stimulation: Current Outlook Sanjay Sastry, MD

Kristen H. Berger, MD

Neil S. Patel, BS

Director of Pain Management Coastal Pain Center South Daytona, Florida

Lake Mary Family Practice Lake Mary, Florida

University of Florida Gainesville, Florida

atients with chronic pain often must wait a prolonged period before they can be authorized for treatment with spinal cord stimulation (SCS); months or even years can elapse before a suitable candidate is identified, informed about the benefits and authorized by health insurance providers for SCS. [Editor’s note: Researchers presenting at the 2014

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© 2014 Cardinal Health. All rights reserved. CARDINAL HEALTH, the Cardinal Health LOGO and ESSENTIAL TO CARE are trademarks or registered trademarks of Cardinal Health. All other marks are the property of their respective owners. Lit. No. 2PERI14-20909 (09/2014)

American Academy of Pain Medicine annual scientific meeting found that the average time from symptom onset to implantation was 5.12 years.] Part of the problem is that many physicians are not sufficiently knowledgeable about SCS. These physicians often believe that every possible method of conservative, interventional and surgical management should be exhausted before SCS is considered. Several intrinsic factors further increase the overall wait times after a patient is consulted; for example, authorization by insurance companies is required for reimbursement, which results in longer wait times. Another factor that loses the patient more time is the scheduling of a permanent implant after a successful trial of SCS. Early recognition of the need for spinal cord stimulators in pain patients will minimize future use of narcotic pain medication. Teaching primary care physicians how to recognize appropriate candidates for SCS is essential to reduce the amount of time that many patients wait before treatment starts. However, a much bigger problem that increases the wait times for patients seeking SCS is the decline in insurance reimbursement (a decrease of 70%-75%). Because of this, the likelihood that doctors will perform a trial of SCS is diminishing. Before the recent reductions in reimbursement, there were some financially motivated physicians who performed trial SCS placement without using proper patient selection criteria, educating the patient, proper lead placement, or proper postoperative care and follow-up. Some physicians placed more than 50 to 100 trial spinal cord stimulators annually without performing a permanent implant, and would consult another physician to implement the latter. There were patients who experienced good pain relief with an SCS trial, yet never received permanent implants. Insurance companies have altered their requirements for SCS authorization in ways that have made it increasingly difficult for patients to receive treatment. Current policy requires patients to attend a face-to-face psychological evaluation with a psychiatrist/psychologist, instead of simply taking a multiple-choice psychological questionnaire as in the past. The current authorization process will see another unnecessary increase soon in wait times for SCS implantation.

OCTOBER 2014

AnesthesiologyNews.com I 2 1

PAIN MEDICINE The changes to autthorization procedures usually are writtten by nonmedical insuurance underwriters or physicians not trained in pain medicine, whicch can lead to mistaken assuumptions. (We have heard off instances in which SCS was assumed to be the same as a trranscutaneous electrical nerve stimulation unit.) We fear that wait times for SC CS will grow even longer because of this frus-trating combination of stricter criteria from insurers, long wait times for authorization and drastic cuts in reimbursement. In contrast, the average wait time for SCS is one to two years in European countries with nationalized health care. Physicians are to blame in part for the changes in authorization. It is also the insurance companies’ shortsightedness and/or reluctance to realize that SCS is an advanced clinical tool that potentially can save money in the long term by reducing a patient’s need

for ppain medication, and allowing for his or her return to work sooner than with more conservative meth hods. We can start to reduce w wait times for SCS by educating prractitioners about its benefits, buut authorization from health insurrance companies will continue to be tthe limiting factor in its use. The current situation in the U United States is not favorable for patients who require immediate SCS to relieve chronic pain. We believe that the severe reductions in reimbursement and longer authorization wait times imposed by the insurance companies will worsen the situation, as many interventional pain management physicians who perform SCS may stop administering this treatment. This problem will have real-life consequences for patients with chronic pain syndromes if it is not remedied. The authors have nothing to disclose.

YOU can reduce post-surgical complications by

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A large body of evidence demonstrates that hemodynamic optimization through Perioperative Goal-Directed Therapy (PGDT), utilizing dynamic parameters which are informative in determining fluid responsiveness, has been shown to reduce post-surgical complications.1–4 randomized controlled trials and

BURNOUT

CONTINUED FROM PAGE 13

a worthwhile undertaking, given how difficult the condition is to treat once it occurs, Dr. Kroll said. “It’s much harder to recover and try to figure out a way to take care of people who are burned out. Studies have shown that it’s much more effective to create employee engagement, and that has to happen at the organizational level.” When asked why there seems to be such a high rate of burnout among pain specialists recently, Dr. Kroll did not hesitate. “Because of recent FDA regulations, primary care physicians refuse to prescribe narcotics,” he said. “So these patients are all coming to pain physicians, and they can be challenging and demanding. It really does create a tremendous psychological demand on the pain physicians. I think we need to create programs to mitigate and prevent burnout in our field.” Charles Argoff, MD, professor of neurology and director of the Comprehensive Pain Center at Albany Medical College, in Albany, N.Y., commented that physician burnout appears to be a growing experience in many fields. “It would not surprise me if it continues to affect a greater number of pain specialists for a variety of reasons, including increasing obstacles to patient

care created by the insurance industry; increasing reluctance by non–pain specialists to manage people in their practice with chronic pain; greater regulation by state and federal authorities of pharmacologic approaches to pain management; and increasing difficulties in receiving appropriate reimbursement for the complex care that pain specialists provide to their patients.” Preventing burnout is a complex undertaking, although Dr. Argofff recommended an old-school approach. “This may appear corny or trite, but focusing on the interpersonal relationships that develop between the provider and the person in pain—as well as the rewards of helping a person in pain suffer less—holds great value in reducing burnout,” he said. “Focusing on being your patient’s advocate and helping your patient to be his or her own advocate also help to actively combat certain obstacles standing in the way of best practices in pain management. There is no clear solution to this, and as long as non-practitioners continue to have the upper hand in how and what care will be allowed, burnout will continue to occur.” —Michael Vlessides

meta-analyses confirmed reduction of risk for AKI, anastomotic leaks, pneumonia, SSI and UTI.1–4 When evidence inspires action, Edwards Enhanced Surgical Recovery program is here to help you implement PGDT. Your vision for reducing post-surgical complications can be realized in a single procedure, or as part of a larger initiative like ERAS, Perioperative Surgical Home or a Quality Improvement Program.

Edwards.com/ESR1 References: 1. Grocott et al. Perioperative increase in global blood flow to explicit defined goals and outcomes after surgery: a Cochrane systematic review. Br J Anaesth 2013 2. Giglio MT, Marucci M, Testini M, Brienza N. Goal-directed haemodynamic therapy and gastrointestinal complications in major surgery: a meta-analysis of randomized controlled trials. Br J Anaesth 2009; 103: 637–46 3. Dalfino L, Giglio MT, Puntillo F, Marucci M, Brienza N. Haemodynamic goal-directed therapy and postoperative infections: earlier is better. A systematic review and meta-analysis. Crit Care 2011; 15: R154 4. Corcoran T et al. Perioperative Fluid Management Strategies in Major Surgery: A Stratified Meta-Analysis. Anesthesia – Analgesia 2012 Edwards, Edwards Lifesciences, the stylized E logo, and Enhanced Surgical Recovery are trademarks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners. © 2014 Edwards Lifesciences Corporation. All rights reserved. AR11710

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22 I AnesthesiologyNews.com

OCTOBER 2014

TECHNOLOGY

Ultrasound-Guided Device Aims To Reduce Central Line Complications San Francisco—A new ultrasoundguided vascular access device could help reduce complications associated with central venous line (CVL) placement, researchers said. The device, which uses ultrasound to map the path of the access device’s needle tip, was

tested by a small group of clinicians and residents who successfully placed 97% of CVLs and did so in 87% of cases on first pass. Lead investigator Robinson Ferre, MD, director of emergency ultrasound in the Department of

Emergency Medicine at Vanderbilt University Medical Center in Nashville, Tenn., explained that the device (AxoTrack system, Soma Access Systems) includes a specialized ultrasound probe and needle guide that allows the needle tip to be tracked

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and a virtual path to be displayed on the monitor as it is inserted through the skin and into the blood vessel. The virtual path is first aligned with the target vessel, and then the needle is inserted through the device’s needle guide and advanced along the virtual path. “Normally, the needle tip can be difficult to visualize throughout the procedure,” said Dr. Ferre, who presented the study results at the Society of Critical Care Medicine’s 43rd Annual Critical Care Congress (poster 228). “But this device essentially turns the procedure into a point-and-shoot process.” Dr. Ferre and his colleagues enrolled two emergency medicine attendings, two emergency general surgery/critical care fellows, one nurse practitioner and four emergency medicine residents to perform 30 CVLs using the device. Before the procedure, Dr. Ferre, who received financial support from Soma Access Systems for this study, trained each participant how to use the device employing a phantom patient, and they subsequently performed at least one live CVL placement under his supervision and before the study. The researcher said nine CVLs were placed through the internal jugular, 17 were inserted using a supraclavicular approach to the subclavian vein and four were inserted using an infraclavicular approach. According to the findings, 97% of CVLs (29 of 30) were inserted successfully, which is comparable to success rates using other techniques. More notable, he said, was the 93% (27 of 29) success rate on first attempt—meaning only one skin puncture was required—and the 87% first-pass success rate. “The best first-pass success rate using a free-handed ultrasoundguided approach is reported to be 50%, but in previous research we conducted, we found a 37% first-pass success rate,” said Dr. Ferre ((Ann Emerg Med 2010;56:S74). He believes fewer attempts and passes lower the risks for complications, such as hematoma, hemothorax and pneumothorax (Table). Alan Kaye, MD, PhD, who is professor and chair of the Department of Anesthesiology and director of pain

OCTOBER 2014

AnesthesiologyNews.com I 23

PAIN MEDICINE Table. Frequency of Mechanical Complications With Central Line Placement Internal Jugular, %

Subclavian, %

Arterial puncture

6.3-9.4

3.1-4.9

Hematoma

<0.1-2.2

1.2-2.1

Hemothorax

Not applicable

0.4-0.6

Pneumothorax

<0.1-0.2

1.5-3.1

Total

6.3-11.8

6.2-10.7

Adapted p from McGee DC, Gould MK. N Engl g J Med. 2003;348:1127.

services at Louisiana State University School of Medicine in New Orleans, and was not involved in the research, said, “Although this was a small study, the results are extremely promising in terms of the high percentage of successful placements on first pass, and the absence of complications.” Dr. Kaye noted that clinicians can be slow to integrate new technologies into practice even when the technologies carry safety benefits. “When ultrasound guidance emerged about a decade ago, many clinicians who had been trained to place lines blind were resistant to learning how to employ

the new technology,” said Dr. Kaye. Widespread adoption is more likely if new technologies are incorporated into the teaching process and if the price tag is manageable, he added. The $11,000 (as quoted by the manufacturer) cost of the new device is “a reasonable price,” Dr. Kaye said. Although the device has received FDA approval only for vascular line placements, Dr. Ferre said he has conducted arthrocenteses, cyst aspirations, fine-needle aspirations, nerve blocks and paracenteses with it and has had no complications. —David Wild

DEA Bumps Hydrocodone-Combination Products to Schedule II Drugs

he U.S. Drug Enforcement Administration (DEA) has reclassified hydrocodone-combination products as the more restrictive Schedule II drugs in an attempt to curb drug abuse. The DEA published the Final Rule in the Federal Register on Aug. 22. The Final Rule will take effect in 45 days and will apply to “all pharmaceuticals containing hydrocodone currently on the market in the United States.” “Almost 7 million Americans abuse controlled-substance prescription medications, including opioid painkillers, resulting in more deaths from prescription drug overdoses than auto accidents,” said Michele Leonhart, DEA administrator, in a press release. “Today’s action recognizes that these products are some of the most addictive and potentially dangerous prescription medications available.”

Schedule II drugs are substances with accepted medical uses that have a high potential for harm and abuse, according the Controlled Substances Act. Hydrocodonecombination products contain both hydrocodone (a Schedule II drug) and other ingredients like acetaminophen, and were originally classified as Schedule III drugs. The move to reschedule hydrocodone-combination products was initiated by petition from a physician in 1999, according the DEA. The DEA then submitted a request to the U.S. Department of Health and Human Services for a medical and scientific evaluation of hydrocodone-combination products and for a scheduling recommendation. They found that the addition of other drugs did not diminish the potential for abuse of hydrocodone-combination products. Based on a press release from the DEA.

Valuable insight to help you guide volume administration. Clarity gives you the control to make more informed decisions. Edwards Lifesciences’ range of hemodynamic monitoring solutions provides key flow parameters shown to be more informative in determining fluid responsiveness than pressure-based parameters.1

Each may be used in Perioperative Goal-Directed Therapy (PGDT) to help ensure patients are consistently maintained in the optimal volume range. The Edwards Enhanced Surgical Recovery Program can help you implement PGDT today.

Know more. Know now. To see how you can individualize therapy under more conditions visit Edwards.com/ESRsolutions 1. Michard F, Biais M. Rational fluid management: dissecting facts from fiction. Br J Anaesth 2012 For professional use. CAUTION: Federal (United States) law restricts this device to sale by or on the order of a physician. See instructions for use for full prescribing information, including indications, contraindications, warnings, precautions and adverse events. Edwards Lifesciences devices placed on the European market, meet the essential requirements referred to in Article 3 of the Medical Device Directive 93/42/EEC, and bear the CE marking of conformity. Edwards, Edwards Lifesciences, the stylized E logo, ClearSight, Enhanced Surgical Recovery Program, FloTrac, and Swan-Ganz are trademarks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners. © 2014 Edwards Lifesciences Corporation. All rights reserved. AR11991

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24 I AnesthesiologyNews.com

OCTOBER 2014

PRN

Bundled Billing or Bungled Billing? • The bundler uses the discounted anesthesia fee to enable it to collect its full, or less-discounted, facilundled billing: the combination of multiple ity fee, professional fee or both. entities’ fees into a single price. What could Either way, the bundler has now achieved an ecobe wrong with that? A lot, depending on who nomic advantage at your expense. is doing the bundling. And, in some cases, depending For example, a plastic surgeon providing purely cosmetic procedures at her solely owned surgery cenon why they’re doing it. ter demands that you “bundle” your fees, at a subHistory stantially reduced rate, with her fees and her facility’s The concept of bundled billing came out of the fees for purposes of providing all-inclusive pricing to hospital world: In order to market for a discrete ser- patients. The plastic surgeon will collect the bundled, vice, for example, a certain surgical procedure, the all-inclusive fee from her patients and pass along your hospital sought to have all, or at least some, of the discounted portion upon collection. physician providers involved in that procedure agree with the hospital on a fixed price for their services. Depending on the nature of the Those prices were then added, together with the hospital’s fixed price for its fee, into the bundle. services provided, it is possible The idea was to present a coordinated, discounted, competitive price for the bundled procedure or that the arrangement violates service. the Stark law, the federal “selfAs the hospital-based providers most certainly involved in all surgical procedures, the anesthereferral” prohibition that applies sia group’s fees were, and are, a key component in hospital-centered bundled billing. to any physician who makes Mark F. Weiss, JD

Metastatic Change Although that hospital-centered business practice has continued, and although even in the hospital context bundling poses significant compliance questions, the original notion of bundled billing, a competitive edge passed through to the customer, has metastasized into a tool used by surgeons and other referring physicians outside of the hospital setting to extract kickbacks from anesthesia providers. This type of metastasized bundling appears to be on the rise as an alternative to the “company model” set up that has attracted regulatory notoriety. (See, e.g., “The Company Model: Is Taking Less Money To Work at a Surgicenter Worth Jail Time?” Anesthesiology News, February 2014, and “OIG Opinion Adds Clarity to Illegality of Company Model,” Anesthesiology News, January 2011.) As a quick refresher, in the company model arrangement, either the ambulatory surgery center controlled by referring physicians or the referring physicians themselves set up a separate anesthesia company to employ the anesthesiologists and nurse anesthetists working at the facility. The owners extract a portion of the profits from the anesthesia service. In the bundled billing scenario, instead of forcing the anesthesia providers into an employment or subcontract relationship via a company model entity, those with control of the referrals demand that the anesthesia providers enter into what they will call a “bundled billing” arrangement with the referral source. This sort of bundling can be misused to shift a portion of the anesthesia fee into the pocket of the bundler: • The bundler collects a larger anesthesia fee from the payor or patient and retains the difference after paying you your agreed-to discounted amount; or

referrals to those with whom the physician has a direct or indirect ownership or investment interest.

The states have AKScounterpart statutes, some of which approach the issue from the same angle as the AKS but may not make any distinction between the source of the patient’s funding, and Mark F. Weiss, JD others that approach the issue from the angle of “fee-splitting,” the sharing of a physician’s fee with certain third parties under certain circumstances. A bundling arrangement that results in the transfer of the referral receiving physician’s fee to the referral source may implicate the AKS and similar state statutes. Additionally, even arrangements that involve no transfer of wealth from the receiving physician to the person or entity coordinating the bundling may trigger a state’s fee-splittingg prohibitions and its corporate practice of medicine prohibitions. Depending on the nature of the services provided, it is possible that the arrangement violates the Stark law, the federal “selff referral” prohibition that applies to any physician who makes referrals to those with whom the physician has a direct or indirect ownership or investment interest, or a compensation arrangement. Stark is a “strict liability” statute that imposes civil not criminal penalties, although the severity of the penalties makes it a distinction without much difference. The states, too, have counterpart selff referral statutes that, depending again on the nature of the services involved, might be triggered. And last, but by no means least, violations of Stark and of the AKS lead to federal False Claims Act liability (commonly spoken of as “whistleblower actions”), in which violators stand liable to regurgitate reimbursement, plus treble damages, and up to $11,000 per claim. Conclusion In terms of intent, all may be above board in connection with a bundling relationship. Or, it could be a poorly designed substitute for a direct kickback, or an alternative to a kickbackk infested company model scheme. No matter which—innocent or deceitful, intent or no intent—bundling arrangements implicate a number of federal and state compliance laws. Tread carefully before entering into one of these questionable relationships. On the other hand, if you have already become involved in one without considering the risks, it’s essential that you engage in a thorough evaluation immediately. In the out-off hospital context, bundled billing is often bungled billing.

Compliance Quagmire The federal Anti-Kickback Statute (the “AKS”) is designed to prohibit payments to physicians and other providers that are made in order to induce the referral of patients whose care is paid for by federally Mark F. Weiss is an attorney who specializes in the business funded health care programs. and legal issues affecting physicians and physician groups on The AKS is a criminal statute and intent is a national basis. He served as a clinical assistant professor of required, but that intent can be inferred from the anesthesiology at USC Keck School of Medicine and practices circumstances and many seemingly appropriate with The Mark F. Weiss Law Firm, a firm with offices in Dallas, arrangements are, upon examination, viewed by the Texas and Los Angeles and Santa Barbara, California, representenforcers, the Office of Inspector General (OIG), as ing clients across the country. He can be reached by email at markweiss@advisorylawgroup.com. highly suspect.

Precedex Premix is the ďŹ rst and only cGMP manufacturer-prepared, premixed dexmedetomidine on the market. Itâ&#x20AC;&#x2122;s available from Hospira, the innovator with the most extensive selection of Precedex products. Only Hospira can offer you Precedex in 4 mcg/mL premix formulations.

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BRIEF SUMMARY OF PRESCRIBING INFORMATION PLEASE SEE PACKAGE INSERT FOR FULL PRESCRIBING INFORMATION.

Precedex™ (dexmedetomidine hydrochloride) Injection For intravenous use.

Precedex

™

(dexmedetomidine hydrochloride) in 0.9% Sodium Chloride Injection

Rx Only

6 ADVERSE REACTIONS 6.1 Clinical Studies Experience Because clinical trials are conducted under widely varying conditions, adverse reactions rates observed in the clinical trials of a drug cannot be directly compared to rates in clinical trials of another drug and may not reﬂect the rates observed in practice. Use of Precedex has been associated with the following serious adverse reactions: • Hypotension, bradycardia and sinus arrest [see Warnings and Precautions (5.2)] • Transient hypertension [see Warnings and Precautions (5.3)] Most common treatment-emergent adverse reactions, occurring in greater than 2% of patients in both Intensive Care Unit and procedural sedation studies include hypotension, bradycardia and dry mouth. Intensive Care Unit Sedation Adverse reaction information is derived from the continuous infusion trials of Precedex for sedation in the Intensive Care Unit setting in which 1007 adult patients received Precedex. The mean total dose was 7.4 mcg/kg (range: 0.8 to 84.1), mean dose per hour was 0.5 mcg/kg/hr (range: 0.1 to 6.0) and the mean duration of infusion of 15.9 hours (range: 0.2 to 157.2). The population was between 17 to 88 years of age, 43% ≥65 years of age, 77% male and 93% Caucasian. Treatment-emergent adverse reactions occurring at an incidence of >2% are provided in Table 1. The most frequent adverse reactions were hypotension, bradycardia and dry mouth [see Warnings and Precautions (5.2)]. Table 1: Adverse Reactions with an Incidence >2%—Adult Intensive Care Unit Sedation Population <24 hours*

1 INDICATIONS AND USAGE 1.1 Intensive Care Unit Sedation Precedex™ is indicated for sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting. Precedex should be administered by continuous infusion not to exceed 24 hours. Precedex has been continuously infused in mechanically ventilated patients prior to extubation, during extubation, and post-extubation. It is not necessary to discontinue Precedex prior to extubation.

1.2 Procedural Sedation Precedex is indicated for sedation of non-intubated patients prior to and/or during surgical and other procedures.

CONTRAINDICATIONS

None

5 WARNINGS AND PRECAUTIONS 5.1 Drug Administration Precedex should be administered only by persons skilled in the management of patients in the intensive care or operating room setting. Due to the known pharmacological eﬀects of Precedex, patients should be continuously monitored while receiving Precedex.

5.2 Hypotension, Bradycardia, and Sinus Arrest Clinically significant episodes of bradycardia and sinus arrest have been reported with Precedex administration in young, healthy adult volunteers with high vagal tone or with different routes of administration including rapid intravenous or bolus administration. Reports of hypotension and bradycardia have been associated with Precedex infusion. If medical intervention is required, treatment may include decreasing or stopping the infusion of Precedex, increasing the rate of intravenous fluid administration, elevation of the lower extremities, and use of pressor agents. Because Precedex has the potential to augment bradycardia induced by vagal stimuli, clinicians should be prepared to intervene. The intravenous administration of anticholinergic agents (e.g., glycopyrrolate, atropine) should be considered to modify vagal tone. In clinical trials, glycopyrrolate or atropine were effective in the treatment of most episodes of Precedex-induced bradycardia. However, in some patients with significant cardiovascular dysfunction, more advanced resuscitative measures were required. Caution should be exercised when administering Precedex to patients with advanced heart block and/or severe ventricular dysfunction. Because Precedex decreases sympathetic nervous system activity, hypotension and/or bradycardia may be expected to be more pronounced in patients with hypovolemia, diabetes mellitus, or chronic hypertension and in elderly patients. In clinical trials where other vasodilators or negative chronotropic agents were co-administered with Precedex an additive pharmacodynamic effect was not observed. Nonetheless, caution should be used when such agents are administered concomitantly with Precedex.

5.3 Transient Hypertension Transient hypertension has been observed primarily during the loading dose in association with the initial peripheral vasoconstrictive eﬀects of Precedex. Treatment of the transient hypertension has generally not been necessary, although reduction of the loading infusion rate may be desirable.

5.4 Arousability Some patients receiving Precedex have been observed to be arousable and alert when stimulated. This alone should not be considered as evidence of lack of eﬃcacy in the absence of other clinical signs and symptoms.

5.5 Withdrawal Intensive Care Unit Sedation With administration up to 7 days, regardless of dose, 12 (5%) Precedex adult subjects experienced at least 1 event related to withdrawal within the ﬁrst 24 hours after discontinuing study drug and 7 (3%) Precedex adult subjects experienced at least 1 event 24 to 48 hours after end of study drug. The most common events were nausea, vomiting, and agitation. In adult subjects, tachycardia and hypertension requiring intervention in the 48 hours following study drug discontinuation occurred at frequencies of <5%. If tachycardia and/or hypertension occurs after discontinuation of Precedex supportive therapy is indicated. Procedural Sedation In adult subjects, withdrawal symptoms were not seen after discontinuation of short term infusions of Precedex (<6 hours).

5.6 Tolerance and Tachyphylaxis Use of dexmedetomidine beyond 24 hours has been associated with tolerance and tachyphylaxis and a dose-related increase in adverse reactions [see Adverse Reactions (6.1)].

5.7 Hepatic Impairment Since Precedex clearance decreases with severity of hepatic impairment, dose reduction should be considered in patients with impaired hepatic function [see Dosage and Administration (2.2) in full prescribing information].

All Precedex Adverse Event

(N = 1007) (%)

Hypotension Hypertension Nausea Bradycardia Atrial Fibrillation Pyrexia Dry Mouth Vomiting Hypovolemia Atelectasis Pleural Eﬀusion Agitation Tachycardia Anemia Hyperthermia Chills Hyperglycemia Hypoxia Post-procedural Hemorrhage Pulmonary Edema Hypocalcemia Acidosis Urine Output Decreased Sinus Tachycardia Ventricular Tachycardia Wheezing Edema Peripheral

25% 12% 9% 5% 4% 4% 4% 3% 3% 3% 2% 2% 2% 2% 2% 2% 2% 2% 2% 1% 1% 1% 1% 1% <1% <1% <1%

Randomized Precedex (N = 798) (%) 24% 13% 9% 5% 5% 4% 3% 3% 3% 3% 2% 2% 2% 2% 2% 2% 2% 2% 2% 1% 1% 1% 1% 1% 1% 1% 0

Placebo

Propofol

(N = 400)

(N = 188)

(%)

12% 19% 9% 3% 3% 4% 1% 5% 2% 3% 1% 3% 4% 2% 3% 3% 2% 2% 3% 1% 0 1% 0 1% 1% 0 1%

13% 4% 11% 0 7% 4% 1% 3% 5% 6% 6% 1% 1% 2% 0 2% 3% 3% 4% 3% 2% 2% 2% 2% 5% 2% 2%

* 26 subjects in the all Precedex group and 10 subjects in the randomized Precedex group had exposure for greater than 24 hours. Adverse reaction information was also derived from the placebo-controlled, continuous infusion trials of Precedex for sedation in the surgical intensive care unit setting in which 387 adult patients received Precedex for less than 24 hours. The most frequently observed treatment-emergent adverse events included hypotension, hypertension, nausea, bradycardia, fever, vomiting, hypoxia, tachycardia and anemia (see Table 2). Table 2: Treatment-Emergent Adverse Events Occurring in >1% Of All Dexmedetomidine-Treated Adult Patients in the Randomized Placebo-Controlled Continuous Infusion <24 Hours ICU Sedation Studies Adverse Event Hypotension Hypertension Nausea Bradycardia Fever Vomiting Atrial Fibrillation Hypoxia Tachycardia Hemorrhage Anemia Dry Mouth Rigors Agitation Hyperpyrexia Pain

Randomized Dexmedetomidine

Placebo

(N = 387) 28% 16% 11% 7% 5% 4% 4% 4% 3% 3% 3% 3% 2% 2% 2% 2%

(N = 379) 13% 18% 9% 3% 4% 6% 3% 4% 5% 4% 2% 1% 3% 3% 3% 2%

Table 2: Treatment-Emergent Adverse Events Occurring in >1% Of All Dexmedetomidine-Treated Adult Patients in the Randomized Placebo-Controlled Continuous Infusion <24 Hours ICU Sedation Studies (continued) Adverse Event Hyperglycemia Acidosis Pleural Eﬀusion Oliguria Thirst

Randomized Dexmedetomidine

Placebo

(N = 387) 2% 2% 2% 2% 2%

(N = 379) 2% 2% 1% <1% <1%

The mean total dose was 1.6 mcg/kg (range: 0.5 to 6.7), mean dose per hour was 1.3 mcg/kg/hr (range: 0.3 to 6.1) and the mean duration of infusion of 1.5 hours (range: 0.1 to 6.2). The population was between 18 to 93 years of age, 30% ≥65 years of age, 52% male and 61% Caucasian. Treatment-emergent adverse reactions occurring at an incidence of >2% are provided in Table 5. The most frequent adverse reactions were hypotension, bradycardia, and dry mouth [see Warnings and Precautions (5.2)]. Pre-speciﬁed criteria for the vital signs to be reported as adverse reactions are footnoted below the table. The decrease in respiratory rate and hypoxia was similar between Precedex and comparator groups in both studies. Table 5: Adverse Reactions With an Incidence > 2%—Procedural Sedation Population

Adverse Event In a controlled clinical trial, Precedex was compared to midazolam for ICU sedation exceeding 24 hours duration in adult patients. Key treatment emergent adverse events occurring in dexmedetomidine or midazolam treated patients in the randomized active comparator continuous infusion long-term intensive care unit sedation study are provided in Table 3. The number (%) of subjects who had a dose-related increase in treatment-emergent adverse events by maintenance adjusted dose rate range in the Precedex group is provided in Table 4.

Hypotension1 Respiratory Depression2 Bradycardia3 Hypertension4 Tachycardia5 Nausea Dry Mouth Hypoxia6 Bradypnea

Table 3: Key Treatment-Emergent Adverse Events Occurring in Dexmedetomidine- or Midazolam-Treated Adult Patients in the Randomized Active Comparator Continuous Infusion Long-Term Intensive Care Unit Sedation Study Adverse Event

Dexmedetomidine

Midazolam

(N = 244)

(N = 122)

56%

28%

27%

42%

19%

28%

42%

Hypotension1 Hypotension Requiring Intervention Bradycardia2 Bradycardia Requiring Intervention Systolic Hypertension3 4

Precedex

Placebo

(N = 318)

(N = 113)

(%)

54% 37% 14% 13% 5% 3% 3% 2% 2%

30% 32% 4% 24% 17% 2% 1% 3% 4%

Hypotension was deﬁned in absolute and relative terms as Systolic blood pressure of <80 mmHg or ≤30% lower than prestudy drug infusion value, or Diastolic blood pressure of <50 mmHg.

Respiratory depression was deﬁned in absolute and relative terms as respiratory rate (RR) <8 beats per minute or > 25% decrease from baseline.

Bradycardia was deﬁned in absolute and relative terms as <40 beats per minute or ≤30% lower than pre-study drug infusion value.

Hypertension was deﬁned in absolute and relative terms as Systolic blood pressure >180 mmHg or ≥30% higher than pre-study drug infusion value or Diastolic blood pressure of >100 mmHg.

Tachycardia was deﬁned in absolute and relative terms as >120 beats per minute or ≥30% greater than pre-study drug infusion value. Hypoxia was deﬁned in absolute and relative terms as SpO2 <90% or 10% decrease from baseline.

25%

44%

10%

12%

15%

11%

15%

19%

30%

Hypokalemia

13%

6.2 Postmarketing Experience

Pyrexia

Agitation

Hyperglycemia

Constipation

The following adverse reactions have been identiﬁed during post approval use of Precedex. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Hypotension and bradycardia were the most common adverse reactions associated with the use of Precedex during post approval use of the drug.

Hypoglycemia

Respiratory Failure

Renal Failure Acute

Acute Respiratory Distress Syndrome

Generalized Edema

Hypomagnesemia

Tachycardia

Tachycardia Requiring Intervention Diastolic Hypertension3 Hypertension

Hypertension Requiring Intervention†

Table 6: Adverse Reactions Experienced During Post-approval Use of Precedex Body System

Preferred Term

Body as a Whole

Fever, hyperpyrexia, hypovolemia, light anesthesia, pain, rigors

Cardiovascular Disorders, General

Blood pressure ﬂuctuation, heart disorder, hypertension, hypotension, myocardial infarction

Central and Peripheral Nervous System Disorders

Dizziness, headache, neuralgia, neuritis, speech disorder, convulsion

Gastrointestinal System Disorders

Abdominal pain, diarrhea, vomiting, nausea

Heart Rate and Rhythm Disorders

Arrhythmia, ventricular arrhythmia, bradycardia, hypoxia, atrioventricular block, cardiac arrest, extrasystoles, atrial ﬁbrillation, heart block, t wave inversion, tachycardia, supraventricular tachycardia, ventricular tachycardia

Liver and Biliary System Disorders

Increased gamma-glutamyl transpepsidase, hepatic function abnormal, hyperbilirubinemia, alanine transaminase, aspartate aminotransferase

The following adverse events occurred between 2 and 5% for Precedex and Midazolam, respectively: renal failure acute (2.5%, 0.8%), acute respiratory distress syndrome (2.5%, 0.8%), and respiratory failure (4.5%, 3.3%).

Metabolic and Nutritional Disorders

Acidosis, respiratory acidosis, hyperkalemia, increased alkaline phosphatase, thirst, hypoglycemia

Table 4. Number (%) of Adult Subjects Who Had a Dose-Related Increase in Treatment Emergent Adverse Events by Maintenance Adjusted Dose Rate Range in the Precedex Group

Psychiatric Disorders

Agitation, confusion, delirium, hallucination, illusion

Red Blood Cell Disorders

Anemia

Renal Disorders

Blood urea nitrogen increased, oliguria

Respiratory System Disorders

Apnea, bronchospasm, dyspnea, hypercapnia, hypoventilation, hypoxia, pulmonary congestion

Skin and Appendages Disorders

Increased sweating

Vascular Disorders

Hemorrhage

Vision Disorders

Photopsia, abnormal vision

†

Includes any type of hypertension.

Hypotension was deﬁned in absolute terms as Systolic blood pressure of <80 mmHg or Diastolic blood pressure of <50 mmHg or in relative terms as ≤30% lower than pre-study drug infusion value.

Bradycardia was deﬁned in absolute terms as <40 bpm or in relative terms as ≤30% lower than pre-study drug infusion value.

Hypertension was deﬁned in absolute terms as Systolic blood pressure >180 mmHg or Diastolic blood pressure of >100 mmHg or in relative terms as ≥30% higher than pre-study drug infusion value.

Tachycardia was deﬁned in absolute terms as >120 bpm or in relative terms as ≥30% greater than pre-study drug infusion value.

Precedex mcg/kg/hr Adverse Event Constipation Agitation Anxiety Edema Peripheral Atrial Fibrillation Respiratory Failure Acute Respiratory Distress Syndrome

≤0.7*

>0.7 to ≤1.1*

>1.1*

(N = 95)

(N = 78)

(N = 71)

6% 5% 5% 3% 2% 2% 1%

5% 8% 5% 5% 4% 6% 3%

14% 14% 9% 7% 9% 10% 9%

* Average maintenance dose over the entire study drug administration Procedural Sedation Adverse reaction information is derived from the two trials for procedural sedation in which 318 adult patients received Precedex.

Adapted from: EN-3411; Revised 12/2013 Manufactured and Distributed by: Hospira, Inc., Lake Forest, IL 60045 USA Licensed from: Orion Corporation, Espoo, Finland P14-0164-5-10.5x13-Feb.,14 Printed in USA Hospira, Inc., Lake Forest, IL 60045 USA

28 I AnesthesiologyNews.com

OCTOBER 2014

TECHNOLOGY

Tubing Misconnections Avoidable, Safe Tubing Procedures Urged

nita Gupta, DO, PharmD, described tubing misconnections as “a reality” of the practice of anesthesiology and the delivery of treatment in hospitals, long-term care centers and hospital facilities. However, Dr. Gupta, vice-chair of the Division of Pain Medicine and Regional Anesthesiology and associate professor, Department of Anesthesiology and Perioperative Medicine, Drexel University College of Medicine, in Philadelphia, also noted that these misconnections can be prevented by the implementation of safety checks and quality-control protocols. And that is the essence of the Joint Commission’s Sentinel Event Alert, entitled “Managing Risk During Transition to New ISO Tubing Connector Standards,” which was published on Aug. 20 to coincide with the beginning of the phased implementation of the new International Organization for Standardization (ISO) tubing connector standards. The alert offers several strategies for assessing and managing risk for injury associated with tubing connection as well as processes and procedures designed to prevent misconnections.

In a statement released with the alert, Mark R. Chassin, MD, FACP, MPP, MPH, president and CEO of the Joint Commission, noted, “Tubing misconnections are the root cause of too many episodes of patient harm. Organizational leadership… must assume the responsibility for ensuring the safe adoption of the new standards and they must empower their employees to not be afraid to speak up if they discover a problem.” According to the alert, accidental tubing misconnections occur because medical tubes with different functions can easily be connected with luer-style

connectors that are used to make leakk free connections between medical tubing. The tubing connections also can be rigged as “workarounds” using adapters, tubing or catheters, and these often can lead to misconnections. For example, the alert highlights more than 100 reported instances of misconnections directing enteral feeding solutions into IV lines. The new ISO standards were developed through collaboration between the ISO and the Association for the Advancement of Medical Instrumentation as well as clinicians, manufacturers and regulators, including the FDA. The standards include engineering specifications for small-bore connectors with an inner diameter of less than 8.5 mm. The authors of the guidelines hope that new connectors designed according to the standards—which are expected to enter the marketplace in October, according to the Joint Commission—will reduce the risk for connecting tubing delivery systems that serve different functions. To prepare for the full implementation of the new ISO standards, the Sentinel Alert recommends that health care facilities form interdisciplinary task forces—including nurses, pharmacists, risk management personnel, health care technology management personnel, biomedical engineering experts and purchasing staff—to identify potential misconnection see tubing page 90

Needleless IV Connectors Significantly Reduce Catheter Fluid Flow Montreal—Needleless connectors for IV tubing have many benefits but also a few drawbacks, including substantially reducing the flow of both red blood cells (RBCs) and crystalloid solutions through large-bore IV catheters, a tendency that may be especially important during emergency situations. “Back in the late 1990s, I noticed that when I hooked a needleless catheter onto a line and tried to run a rapid infusion, it ran at a much slower rate,” said Joseph McIsaac, MD, chief of trauma anesthesia at Hartford Hospital in Hartford, Conn. “So I ran a small study looking at crystalloid flow through the Clave connector, and was able to demonstrate a significant difference in flow. Fast forward to today, where we’ve decided to do a more robust study comparing several devices.” Dr. McIsaac and clinicians at the University of Connecticut undertook the current trial, comparing five models of needleless connectors. In each case, a Level 1 H-1200 Fast Flow Fluid Warmer (Smiths Medical) was used, either to deliver crystalloid or RBCs

under pressure during simulated massive transfusion. Trials compared flow rates for each of the devices and one control (i.e., no connector) with a variety of IV catheter sizes: 9-Fr introducer, 7-Fr rapid infusion catheter, as well as 14-, 16-, 18-, 20- and 22-gauge IV catheters. Each series of trials comprised one control and a different needleless connector used with the array of catheters and an identical transfusion fluid. Flow rates were measured by timed delivery of 10 to 100 mL volumes in a graduated cylinder. “We wanted to use enough devices to cover most of what’s out there so we could have a study that’s more applicable and generalizable,” commented co-investigator Andrew Lehn, MD, a resident at Hartford Hospital. “We ended up getting five devices, which is a fair representation of what’s out there.” As reported at the International Anesthesia Research Society 2014 annual meeting (abstract S-92), all five needleless connectors substantially reduced flow of crystalloid and RBCs. Indeed, RBC flow rates were reduced

by 56%±7% for the 9-Fr introducer; 57%±7% for the 7-Fr rapid infusion catheter; 53%±7% for the 14-gauge IV; 45%±8% for the 16-gauge IV; 31%±6% for the 18-gauge IV; 23%±5% for the 20-gauge IV; and 11%±4% for the 22-gauge IV. Average crystalloid flow reductions were 67%±6% (9-Fr introducer), 69%±5% (7-Fr rapid infusion catheter), 60%±6% (14-gauge IV), 51%±7% (16-gauge IV), 33%±7% (18-gauge IV), 21%±6% (20-gauge IV), and 17%±5% (22-gauge IV). “So we recommend that if you place a large catheter and you need to give fluids quickly, don’t use a needleless connector,” Dr. Lehn said. “Because as we noticed, if you put in a 9-Fr or a 14-gauge and then add the needleless connector, you’re essentially putting in an 18- or 20-gauge, so why risk a large catheter if you’re not getting the flow rates you’re after? If it’s a small case and you’re only infusing a nominal amount of fluid, go ahead and put one on.” As Dr. McIsaac explained, this phenomenon has the potential to affect

clinical care, particularly in cases of trauma and massive transfusion. “Not only do you have to give the proper combination of blood products to stop coagulopathy and reconstitute the volumes that the patient perfuses, but you need to give it fast enough that it makes a difference,” he said. “And to have a two-thirds reduction in your ability to give that blood rapidly means your patient may not survive to get out of the hospital. “If you’re bleeding to death, this really matters.” Hilary P. Grocott, MD, professor of anesthesia and surgery at the University of Manitoba in Winnipeg, Manitoba, Canada, noted that although needleless systems offer many advantages—including the potential reduction of needlestickk injuries—they appear to come at a cost in terms of high-pressure flow rate functionality. “Just as considerable engineering efforts went into designing these systems to reduce the requirement for needle use, similar efforts will now be needed to minimize a problem that seems to have arisen as a result,” Dr. Grocott told Anesthesiology News. “In addition, flow-rate system differences may well be another comparator for purchasers to consider when choosing between vendors.” —Michael Vlessides

30 I AnesthesiologyNews.com

OCTOBER 2014

POLICY & MANAGEMENT

Intervention Reduces Inappropriate Pre-Op Chest X-Rays in Low-Risk Patients New Orleans—Chest x-rays often are included in routine preoperative testing for patients undergoing low-risk elective surgery but are infrequently indicated. An educational intervention successfully lowered the frequency with which this “inappropriate” test

is ordered, and in so doing helped decrease the utilization rates of several other types of preoperative testing as well. “Like most institutions, we were looking at costs and recognized we might not be operating as efficiently

as possible,” said Jonathan P. Wanderer, MD, assistant professor of anesthesiology at Vanderbilt University, Nashville, Tenn. “As part of that, we’ve been implementing changes when medical practice suggests we should be doing things differently than we currently are.

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And one area where that’s clear is chest x rays, which used to be part and parcel xof the preoperative workup, but from a screening standpoint don’t have that much value.” An electronic learning module was created that specified indications for preoperative chest x-rays; all surgical providers were required to complete the module during August 2012. The researchers then identified and analyzed preoperative testing orders between February 2009 and March 2014, including chest x-ray, y electrocardiogram (EKG), basic metabolic panel (BMP), packed cell volume (PVC), platelets, comprehensive metabolic panel, complete blood count (CBC), partial thromboplastin time/prothrombin time (PTT/PT), type and screen, urinalysis and “other labs.” The procedures were then stratified according to American Society of Anesthesiologists (ASA) physical status and surgical risk classifications. In all, 43,320 anesthetic records were identified before the intervention date, compared with 24,013 after. The rate of requested chest x-rays fell from 33% to 20% (P<0.001). More telling was the fact that during the last six months of data, chest x-rays were requested in only 16% of surgical cases. In the subpopulation of low-risk patients (ASA physical status 1) undergoing low-risk surgery, chest x-ray rates fell from 8% to 2% (P<0.001). “Subsequent analysis revealed that there were a handful of clinicians who were responsible for almost all the remaining orders,” Dr. Wanderer told Anesthesiology News. “So we’ve been working with them directly, and have effectively dropped the rate even further. So I think we’re now down to the point where we’re ordering them when there’s an acute disease process or surgical procedure where imaging will be helpful.” Perhaps not surprisingly, EKG, PCV, BMP, PTT/PT, comprehensive metabolic panel, CBC, urinalysis and platelets all showed statistically significant see x-ray page 34

LT-077 Rev. 0

OCTOBER 2014

AnesthesiologyNews.com I 31

POLICY & MANAGEMENT

Clean Workstation Initiative Alters Perceptions, Lowers Infection Risk New Orleans—Although previous research has shown that anesthesia workstations and equipment often are sources of hospital-acquired infections, cleaning up their proverbial act may come from something as simple as a standardized system to increase workstation turnover. Indeed, a Massachusetts General Hospital study has found that implementing such a system improves providers’ perception of workstation cleanliness and their use of alcohol-basedd hand sanitizer. “Despite diligent cleaning of anesthesia workstations between cases, it is intuitive that minimizing the amount of workspace contamination would potentially reduce cross-contamination and make our operating rooms [ORs] safer for patients,” said T. Anthony Anderson, MD, PhD, instructor in anesthesia at Harvard Medical School, Boston. The investigators began the undertaking by surveying the institution’s

providers and technicians, an exercise aimed at gauging both their perception of workstation cleanliness and interest in adopting a standardized turnover; positive feedback led to the design of the turnover system, dubbed the Clean Workstation Initiative. “We spent a lot of time gauging openness through surveys,” Dr. Anderson explained. “We also viewed it as a way to get people ready to accept the idea of change. A fair percentage of the department staff didn’t think the cleanliness was optimized and there could be things done to change it. “Initially we identified some areas of potential cross-contamination,” Dr. Anderson said in an interview with Anesthesiology News. “As part of that, we labeled them as either ‘dirty’—surfaces that come in contact with patients or used supplies—or ‘clean’, meaning they have no contact with the patient or used supplies.” The anesthesia machine tray

and OR bed were both labeled dirty, whereas the anesthesia cart and top of the anesthesia machine were dubbed clean. As part of the protocol, an anesthesia technician discarded all items left on the tray after the case. The tray was then wiped down, a clean towel placed on its surface, and a card left on the tray with the technician’s name and pager number to signify turnover completion. In addition to this turnover process, alcoholbased hand sanitizer dispensers were installed on, or immediately adjacent to, the anesthesia carts within the anesthesia workstations. Brackets for premoistened disinfectant wipes and “emergency drug” syringes also were designed, built and tested in a subset of 10 ORs. “We actually spoke with the OR engineering unit and had them build prototypes of a clamp that connected the hand sanitizer to the anesthesia carts,” said Dr. Anderson, who is presenting

his findings here at the 2014 annual meeting of the American Society of Anesthesiologists (abstract A2182). “We also spoke with departmental leadership on numerous occasions to gather financial and conceptual support.” Gaining this support was critical to the program’s success, he added. see workstation page 33

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32 I AnesthesiologyNews.com

OCTOBER 2014

POLICY & MANAGEMENT PERIOPERATIVE

accidents were not rare. “It suggested that with better equipment, we would prevent some of these catastrophes,” recent improvements in anesthesia said Dr. Clergue, who is also head of care, which started in the 1980s when Intensive Care Medicine. “Remember, a series of surveys on safety were pub- at that time instrumental monitoring lished. These surveys found intraop- was applied to less than 50% of aneserative mortality rates of 2 per 10,000 thetized patients.” cases in Finland and 1 to 4 instances Epidemiological studies have of death or coma per 10,000 cases in since found that mortality has plumFrance. Research found similar results meted more than 10-fold from 1980 across Europe. Analyses showed that to the end of the 1990s, with curequipment failures and disconnection rent anesthesia-related mortality rates CONTINUED FROM PAGE 1

in both Europe and the United States between 4 and 8 deaths per million cases. How did that happen? “We first had to change the mental model in which we had been educated,” Dr. Clergue said. “We had to admit that these errors are not so rare.” From that admission came a series of improvements that focused on three overall areas: the standardization of training, better medical equipment and drugs, and improved facilities (e.g., the

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postanesthesia care unit). Training was improved to reflect the new understanding of how errors occurred, and errors in selection, dilution and labeling of drugs were addressed by colorcodingg the drugs and making labeling easier to read. With the resultant diminution of accidents came reduced insurance premiums for anesthetists and a reduction in their malpractice claims, even in the United States. “I think we can be very proud,” Dr. Clergue said. Positive Changes Mean Increased Demand However, since anesthesia has become safer, the demand for anesthesia has increased dramatically. “About 7% of the European population was anesthetized in 1980, which increased to 13.5% in 1996.” The largest percentage increases in anesthetization have occurred in elderly patients, and the number of surgeries per population in many cases has doubled. The challenge is to manage the explosion in demand for anesthesia. “The population growth over the last 30 years in Europe was about 16%, but during the same time the growth of anesthesia cases was 322%,” Dr. Clergue noted. This represents a staffing challenge. The density of anesthesiologists in Western Europe was 5.1 per 100,000 population in 1980; today, it is 16.2 per 100,000. That sounds good, but baby-boomer anesthesiologists are retiring: “Between 2012 and 2016, 2,000 French anesthesiologists will retire. The growth of the number of anesthesiologists was greater than the growth of the activity between 1980 and 1996, but during the next period, between 1996 and 2010, this was reversed.” Countries will deal with this problem in different ways. Some European countries now allow nurse anesthetists to work unsupervised by anesthesiologists in the operating room, and this practice will increase as the decade progresses. Dr. Clergue emphasized the connection between staffing and safety. “An important challenge that we have for the next few years will consist of maintaining the present level of safety, but this can be done only if staffing is still growing and adapting to the increasing demand for anesthetics. If this is not the case, in 10 years, our staffing should increase by 50%, and in 20 years our staffing should double. Is that realistic?” The Perioperative Challenge For Dr. Clergue, the challenge for anesthesiologists over the next decade

OCTOBER 2014

AnesthesiologyNews.com I 33

POLICY & MANAGEMENT will be to tackle the problems of safety within the perioperative period with the same deliberation and success as the problems that were confronted back in the 1980s in intraoperative anesthesia safety. “With the improvement in anesthesia safety, we have come to the present situation in which the indications for surgery have been extended to more severe patients. The result is that if anesthesia [remains] safer, postoperative mortality will remain unchanged, around 1.5%,” Dr. Clergue said “For the next decade, the major safety challenge of the surgical patient is to reduce postoperative complications. It is known that the first complications to appear postoperatively greatly increase the risk for death. Yet not many complications that begin in the postoperative period are directly related to anesthesia, so anesthesiologists might be wading into an area outside their direct control—perhaps, but not necessarily outside anesthesiologists’ direct influence.” Anesthesiologists, together with surgeons, can embrace procedures that

heighten safety. One such procedure is the implementation of the SURPASS (SURgical Patient Safety System) checklist (de Vries EN, et al. Qual Saf Health Care 2009;18:121-126) which averts preventable adverse events through the implementation of multidisciplinary checklists. In one study (de Vries EN, et al. N Engl J Medd 2010;363:1928-1937), infection rates were reduced from 4.8% to 3.3% (P=0.006) and death rates from 1.5% to 0.8% (P=0.003) in hospitals that implemented the SURPASS program. Dr. Clergue challenged his audience to reduce postoperative mortality by one-fifth by maintaining and improving levels of patient safety, ensuring adequate staffing, controlling demand for anesthetic agents, and embracing the additional oversight of the perioperative period. Anesthesiologists have proved that they are capable of analyzing safety procedures and implementing corrections, he said. The next decade should see those capabilities used to improve the full spectrum of perioperative care. —James Prudden

WORKSTATION

CONTINUED FROM PAGE 31

Equally important was promoting departmental awareness among all providers and technicians, an undertaking addressed through a variety of communication methods, including information sessions, emails and reminders viewed on hallway LCD screens. To assess provider attitude toward the initiative, a second survey was administered six months after the rollout. Results from 99 surveys revealed that 89.9% of respondents were willing to adopt a new standardized turnover procedure. Using a scale ranging from 1 (“poor”) to 5 (“excellent”), 78.2% of respondents rated workstation cleanliness at 4 or 5 after the initiative’s rollout compared with only 39.1% before, and 21.7% of respondents rated cleanliness at 5 after rollout compared with only 10.0% before. Finally, although 24.6% of respondents rated cleanliness at 1 or 2 before the initiative, none did so after.

Respondents’ reported use of hand sanitizer during every case showed a similar boost, increasing from 59.4% before the initiative to 72.5% after. And although 5.8% of respondents reported never using hand sanitizer before the initiative, this fell to 1.4% after the initiative was implemented. Although the turnover process improved perception of workstation cleanliness and increased the use of alcohol-based hand sanitizer, Dr. Anderson recognized that further research is necessary to investigate any possible connection between the initiative and rates of hospital-acquired infections. “For all our success, it’s important to note that the initiative requires constant upkeep, energy and attention in order to prevent backsliding of the process,” he said. “I’m hoping it’s going to become routine in our practice and everyone will be used to it. I still think we are a couple of years away from that.” —Michael Vlessides

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34 I AnesthesiologyNews.com

OCTOBER 2014

POLICY & MANAGEMENT

Link Between Anesthetic Agents, Technique And Cancer Outcomes Needs Research

consensus statement on the possible link of anesthetic technique and anesthetic agents to risk for cancer and cancer recurrence underscores lack of definitive evidence and the need for further research. The statement was recently published online in the British Journal of Anaesthesia (BJA 2014 Aug 7. [Epub ahead of print]). The experts conclu ded that, although there are conflicting ing views on whether anesthetic techn nique might affect cancer outcome, “th here is currently insufficient eviddence to support any change in clinical practice.” The stattement also noted that ran ndomized clinical trials are needed to evaluate the effect of drugs on cancer recurrence and metastasis.. According to the expertss, current data on opioids sugggest either a protective or no effect for cancer. The statem ment said that there is no evidence that hat morphine analgesia causes cancer, but whether opioids affect the risk for recurrence after cancer surgery remains unclear. “Although it is by no means unanimous, the balance of available evidence from laboratory cancer cell cultures, live animal models, clinical retrospective analyses and translational studies from patients randomized to a prospective trial suggests that certain anesthetic and analgesic techniques may be more beneficial than others in cancer,”

X-RAY

saidd Donal J. Buggyy, MD, professor of anesthesiology aat University College Duublin, Ireland, in an email to Anesthe Anesthesiology News. Dr. Buggyy ran the two-day BJA workshop at the College of Anaesthetists of Ireland, in Dublin. Daniel I. Sessler, MD, who attended the meeting and signed the consensus statement, told Anesthesiology News that in addition to regional analgesia, there are two drug classes of particular interest: lidocaine, delivered intravenously, and the nonsteroidal analgesic class of cyclooxygenase (COX)-2 inhibitors.

“Both have been shown in mechanistic and animal studies to either inhibit cancer or enhance immune function in ways that should reduce the risk for cancer recurrence. The primary defense against new cancers and cancer recurrence is natural killer cells. The problem is that natural killer cell function is impaired by the surgical stress response by volatile anesthetics and by opioids,” explained Dr. Sessler, r who is Michael Cudahy Professor and Chair, Department of Outcomes Research at the Cleveland Clinic in Ohio. “Regional analgesia reduces the surgical stress response and decreases the need for volatile anesthetics and opioids. Intravenous lidocaine is anti-inflammatory

and appeears to enhance natural killer cell fun nction, and the same is true for COX-22 inhibitors. In theory, then, eitheer or both might be helpful.” Dr. Sessler emphasized that D th his is still just theory, and tthe most important takeaway from the consensus panel is that there is good reason for ddoing research, but there isn’t en nough data to suggest changes in ppractice. Jon nathan Moss, MD, PhD, professor of anesthesiology and critical care at a The University of Chicago, agreed that th this is the best course of action until there is strong evidence supporting a need for change. “A lot of times these retrospective studies have confounding variables that we don’t understand,” said Dr. Moss. “I think, as a clinician, opioids are extremely useful. And we don’t want to scare our patients.” Dr. Moss was also present at the BJA meeting but did not sign the consensus because he and others have done cellular, molecular and animal work suggesting that opiate antagonism may influence cancer progression in these model systems. He noted that he is a developer of the peripheral opiate antagonist methylnaltrexone and receives royalties from its sale as well as consulting fees from Salix Pharmaceuticals. —Martin Leung

CONTINUED FROM PAGE 30

reductions in relative frequencies after the intervention date. Interestingly, type and screens and “other labs” showed statistically significant increases in relative frequencies after the intervention date. Dr. Wanderer, who is reporting his findings here at the ASA’s 2014 annual meeting (abstract A1140), had only good things to report about the program’s success, which he said demonstrates that changing physician behavior may not be as difficult as some believe. “Some of our practices get backed into our routine procedures and aren’t really second-guessed,” he said. “We learned that some of the check boxes that were being selected during the preoperative workup weren’t an intentional decision by the surgeon, but were almost filled out by default.” And because these practice patterns are certainly not limited to Vanderbilt, employing similar steps

may help other institutions achieve the same benefits. “We’re now taking a closer look at our rationale for ordering EKGs, another area where we found that we could change our practice,” he added. “We’ve again ended up having conversations with our colleagues and convinced them that we needed a reason to order the test rather than just doing it routinely. And that has resulted in practice changes by merely asking the question: If we do this test, what value are we likely to get from it?” Charles B. Watson, MD, emeritus chair of anesthesia and deputy surgeon-in-chieff at Bridgeport Hospital in Bridgeport, Conn., explained that because of the low incidence of positive findings from age-related or routine chest x-rays, his institution does not perform routine chest x-rays unless the patient has known active disease or new findings

suggestive of pulmonary pathology. “The ASA has published guidelines on preoperative testing since the early 2000s and not identified routine testing of healthy individuals as useful [Anesthesiology [ 2012;116:522-538],” he said. As Dr. Watson explained, educating medical practitioners on the benefits of avoiding routine chest x rays can sometimes take years, as it did at his instixtution. “Information was circulated by email, policy documents to offices and physicians, and in meetings/surgical conferences over the years,” he said. “Now, our staff rarely order chest films, and only with positive clinical findings. The surgical motivation for screening patients for active symptoms of pulmonary disease is the understanding that last-minute chest films will likely delay their procedures.” —Michael Vlessides

OCTOBER ER 2014 014 14

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Fiv Fiive yea a ars late ter, err, you er, y uw yo wer ere re rea re eadin ng analgesia.” Dr. ana sia and septic ible Patients Norris is Pro workups in neo lgefess of Anesthesiol S is institutional nates ogy, Obstetrics or —As free-stan Gynecology, trig and ding ambulatory Wa surgery centers suggested a sess gers for workups, ry “Th School of Med shington Uniiversity Th pro ion moderator, e lifer question is, whi ate and office abo bou bout the he ee effect cts cts—or orr lack k tthereo o of—off w weath he er an and nd nd ast as astro rol olog gy on n icine, based anesthe study presenters two ch patients sia expands, The American St. Louis, Mo. velop co and members complications locatio of care is taki the audience Academy of io of that will ng her iatrics (AAP) Pedadmission or doe tance. Who sho on primary imp meeting of the e at the 1999 annual po o direct uld be treated policy on neo s not have a firm whe natal septic wor Anesthesia and Society for Obstetric he post osto stopera erat rative e n nause se ea and nd vom m miting g and w whethe e r non nonon-a onn-an an a nes est sthe eTo Wee have tto prevent for isolated feve Per kup patients on an having to tran n “Most studies inatology (SOAP). a woman who r in the mother. In emergent bas the hospital, is analgesia is an show that epidural anesthesiologis sii tomatic—no uter completely asympindependent pre tss identify patients tor of maternal siolo olo ologist sts wor wo orking ng g alon on ne co ou uld sa a afely ca a are for ped pe edi diMcM mal urine—with ine tenderness, norrtemperature greadicwith unstab ab high-risk med than 38 C,” said aho delivery, epid isolated fever after ical condition n Pu moderator Dr. ter n ura make sure the Mark C. 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36 I AnesthesiologyNews.com

OCTOBER 2014

PRN

Are Hospitals Still Striking Out on Key Med Safety Standards?

ospitals appear to be in a two-year slump when it comes to complying with potentially lifesaving medication safety standards. And much like baseball managers who often take the fall for their players’ failure to perform at peak levels, pharmacy directors are at risk for termination if they can’t get their staffers to toe the line when it comes to following safe medication practices. That was the message espoused during a recent Institute for Safe Medication Practices (ISMP) webinar, where the lagging statistics on medication safety were front and center. Indeed, as many as 35% of hospitals surveyed by the Joint Commission in 2013 did not comply with medication-related standards in 2013, according to data provided by webinar presenters. The rates of noncompliance remained nearly unchanged between 2012 and 2013, and the most frequent issues were related to drug storage, ordering, pharmacist order reviews, improper labeling and medication reconciliations (Table). The findings prompted Darryl Rich, PharmD, MBA, a medication safety specialist at the ISMP in Horsham, Pa., to urge pharmacy directors to work with other departments to avoid potential consequences of noncompliance. “In my experience, hospitals that are accredited by the Joint Commission and receive a report showing noncompliance with a lot of medication management standards typically hold the pharmacy director responsible, even when the issues involve other departments,” said Dr. Rich, who moderated the ISMP webinar. “Unfortunately, I have known of pharmacy directors who were fired because of a poor report.” Pat Adamski, RN, MS, MBA, the director of projects in the Division of Healthcare Improvement at the Joint Commission, and who shared these findings on compliance during the ISMP webinar, said that a common struggle emerged during field reviews. “Many of the issues we observed were related to poor communication between pharmacists, nurses and Table. Noncompliance With Top Medication Standards Scores in 2013 Standard Number

Description

2012a 2013b

Medication storage

35%

MM.04.01.01

Medication orders

26%

22%

MM.05.01.01

Pharmacist review

15%

16%

NPSG.03.04.01

Labeling in procedures

14%

13%

NPSG.03.06.01

Medication reconciliation

MM.01.01.03

High alert medications

MM.05.01.09

Medication labeling

MM.05.01.07

Medication preparation

1,483 full surveys in 2012.

1,413 , 3 full u surveys su eys y in 2013. 0 3

physicians,” she said. “Organizations can have defined policies and protocols in place, but if they’re not doing a good job of communicating these [steps] to everyone, they’ll get into trouble.” Storage ge Wars Gaps in communicatioon may have been partly responsible for rattes of noncompliance with the Joint Commission’s medication storaage standard (Medication n Management [MM] standard 03.01.01), Ms. Adamski said. She reported that Joint Commission surveyors found medication carts left unattended in n unlocked rooms, and discovscovered instances of unauthorized personnel and former employees having access to locked medication areas and automated dispensing devices. “If staff are using bio-identification for automated dispensers, they need to be reminded to log out when they’re done,” Ms. Adamski said. “That’s a gap in communications that can be easily fixed.” Other issues of noncompliance with the medication storage standard included storage of drugs that were not clearly labeled as to their contents, expiration dates and applicable warnings. “We primarily saw this with sterile, injectable multidose vials, which need to be relabeled with a revised date after the multidose vial is accessed the first time,” she explained. These instances of noncompliance also may be partly a function of some confusion regarding the definition of a “revised date,” Ms. Adamski said. For those seeking clarity on the matter, she pointed to the Joint Commission’s FAQ section on the topic (http://bit.ly/XBnGhr), which states that “multidose vials are to be discarded 28 days after first use unless the manufacturer specifies otherwise.” Another storage issue that Joint Commission surveyors found, and that potentially could compromise the safety and efficacy of drugs, is storage at temperatures outside the range specified by manufacturers. “Although we’ve been seeing greater diligence in recording and monitoring temperatures, the problem we’re finding now is that there is sometimes no evidence that steps were taken in light of documented temperature fluctuations,” Ms. Adamski said. Pharmacists can help mitigate the risk for administering compromised medications by developing and communicating clear protocols that outline what personnel need to do and who they need to notify if they notice temperature fluctuations, she suggested. Within the medication storage standard, Ms. Adamski said Joint Commission surveyors found expired drugs were sometimes in storage areas. “One step that can reduce the likelihood of stocking expired medications is to ask staff to inspect the medication areas in units or departments they don’t work in, to see it with fresh eyes,” she said. “You get so used to your own area that you can miss things.”

Outside of the pharmacy storage area, Joint Commission surveyors found drugs that had not been delivered to patient care areas in the most ready-toadminister form, as one of the elements of the medication storage standard specifies. Following this dictum limits the nu number of times an agent is manipulated an nd handled before administration, an nd therefore reduces the likelihoodd of contamination or dosiing errors, Ms. Adamski eexplained. Ordering Issues Nearly one-fourth of surveyed hospitals failed to comply with the medication ordering standard (MM.04.01.01), according to Ms. Adamski. acco The most frequent type of noncompliance with this standard was improper implementation of medication order policies. “It’s always a challenge to have people follow written policies, especially when they’re in a time crunch,” she observed. Time crunches may have led some staff to place orders without complete instructions as to the route of administration, frequency of use and titration measures, as Joint Commission surveyors found was sometimes the case. Ms. Adamski reiterated the importance of clear communication, urging pharmacy nursing and medical directors “to work with front-line staff to understand why they’re not following policies.” Other instances of noncompliance with this standard that surveyors found included standing orders without the required approvals, orders that were not patient-specific and orders that were not based on the most up-to-date evidence, Ms. Adamski said. Medication Reviews Can Be Tricky In 16% of surveyed hospitals, Joint Commission surveyors found medication orders that had not been appropriately reviewed by a pharmacist. Ms. Adamski said there are exceptions that allow orders to be filled without pharmacist review (MM.05.01.01; see sidebar), but hospitals need to clearly define and document what those exceptions are, based on the requirements detailed in the elements of performance (EPs). “We don’t want to delay care, but we need hospitals to develop clear policies and guidelines regarding which scenarios do not require pharmacist order reviews,” she explained. Improper Labeling Joint Commission surveyors also found improperly labeled agents in procedural areas in 10% of surveyed hospitals (National Patient Safety Goal 03.04.01). Appropriate labeling in these settings is particularly crucial if agents are not being “immediately administered,” Ms. Adamski said. “The definition of ‘immediately administered’ is that an authorized staff see Joint Commission page 38

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38 I AnesthesiologyNews.com

OCTOBER 2014

PRN JOINT COMMISSION

CONTINUED FROM PAGE 36

and procedures, Ms. Adamski said. She noted that individual hospitals may decide on the type of information to collect during medication reconciliations, and that this can even vary across Medication Reconciliation departments and scenarios, but surveySix percent of hospitals failed to fully ors require clear documentation of these comply with the Commission’s medi- policies and evidence that staff is implecation reconciliation standard (NPSG menting them. 03.06.01), although some of these were Notably, surveyors found instances related to the absence of written policies in which staff had obtained medication member prepares or obtains the medication, takes it directly to the patient, and administers it to the patient without a break in the process.”

Are you treating more obese surgical patients at risk of OSA?

information from patients but failed to complete the most crucial element of the reconciliation process. “In some cases, they were not comparing the information they received from medication histories to the inhospital orders,” she noted. “Collecting the information isn’t good enough— you need to make sure you’re doing something with it by identifying and resolving any discrepancies.”

curaplex

more conscious the patient "...the is on arrival at the recovery room, the lower the incidence of respiratory complications.*

Exceptions to the Standard Medication Order Review

M.05.01.01 EP [Element of Performance] 1 specifies that before dispensing or removing medications from floor stock or from an automated dispensing machine, a pharmacist needs to review all medication orders unless: • A Licensed Independent Practitioner (LIP) controls the ordering, preparation and administration of the medication, including remaining at the patient’s bedside during administration. In an emergency department, an LIP is not required to remain at the bedside when the medication is administered. However, an LIP must be available to provide immediate intervention should a patient experience an adverse drug event. • A delay would harm the patient in an urgent situation. Organizations are expected to determine what qualifies as urgent. • In radiology areas, a pharmacist does not need to review contrast agent orders but the hospital is expected to define, through protocol or policy, the role of the LIP in the direct supervision of a patient during and after intravenous contrast media is administered. —D.W.

Patients are more alert on PACU arrival and ready for discharge up to 25% sooner. As obesity rates rise and the population ages, surgical patients are frequently at risk for respiratory complications such as OSA. ANEclear keeps these patients awake, alert and more in control of their airway in the OR and PACU.

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Ms. Adamski concluded by singling out a standard with relatively low rates of noncompliance but potentially profound implications if not properly followed. “If you do nothing else, please get your organization to talk about what process you have in place to perform medication management systems evaluations [MM 08.01.01],” she urged. The standard calls for organizations to collect data on the performance of their medication management systems, to identify points that carry safety risks and to address weaknesses using best practices and published evidence. “Rip apart your processes and evaluate or assess everything,” Ms. Adamski said. “If you do a good job of evaluating your medication management system, the rest of the standards will fall into place.” —David Wild

For more information, please contact your Account Manager or call Customer Service at 800-TRI-ANIM (874-2646). 800-874-2646

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*T. Asai, K. Koga, R.S. Vaughan, “Respiratory complications associated with tracheal intubation and extubation,” British Journal of Anaesthesia, 1998; 80: 767-775

Ms. Adamski and Dr. Rich reported no relevant financial conflicts of interest.

OCTOBER 2014

AnesthesiologyNews.com I 39

PRN

Smaller Is Better for Cutting Costs of Fluid Overload Las Vegas—Not only can fluid overload increase a patient’s risk for death, but it can add several days to their hospital length of stay (LOS) and more than $15,000 to the total health care cost, according to a study presented at the American Society of Health-System Pharmacists Summer Meeting (poster 18-T). Fluid overload is a serious condition that can affect many organs and systems in a person’s body, including the heart, lungs and kidneys (Hemodial Int 2010;14:348-354). It also is associated with cardiac and renal dysfunction that can lead to a continuous treatment cycle to properly manage patient needs (Pediatr Crit Care Medd 2014;15:131-138). Researchers at Smiths Medical, a global provider of medical devices, conducted a study to determine the potential burden of illness of fluid overload and the resulting effect on U.S. health care and pharmacy dispensing. The retrospective cohort study was designed to improve understanding of the potential benefits of conservative fluid management, such as small-volume, maximally concentrated IV solutions delivered via a syringe pump, in contrast to current medication modes of delivery. The study was carried out using information from the Premier Healthcare Solutions (a large group purchasing organization) research database. Subjects consisted of adult patients with a hospitalization that included time in an ICU, central line placement, the administration of an IV loop diuretic and at least two medications from a list of commonly used continuous infusions for at least 50% of ICU days. The database generated 63,974 directly matched patients in each of the fluid overload and comparison cohorts. The fluid overload cohort had an average of 56.7% higher overall hospital costs per visit ($42,368 vs. $27,042), 92.7% higher ICU costs ($10,902 vs. $5,659), and correspondingly longer hospital (11.5 vs. eight days) and ICU LOS (6.2 vs. 3.6 days). These patients also had higher rates of mortality (20% vs. 16.8%) and 30-dayy readmission (21.82% vs. 21.28%) than the comparison group. The researchers also reviewed a subset of common continuous vasopressor medications used in the study, and compared the daily fluid savings from the maximal concentration as opposed to a commonly used standard concentration for patients of average weight and dosage. Fluid savings varied from 460

mL (nitroprusside) to as much as 8,294 mL (epinephrine) per day for the medications reviewed, and patients were required to have at least two of the study medications during their ICU stay.

fluid intake, according to primary study author Debbi Child, PharmD, BCPS, a clinical resource specialist at Smiths Medical. Dr. Child also pointed to practice patterns that may contribute to fluid overload. “While mediContributing Factors cation delivery models vary between The results underscore the fact that institutions, it’s common that conmedication administration can continuous medications for U.S. adult tribute significantly to a patient’s daily ICUs are provided in premixed dilute

formulations,” she said. “Physicians typically order the drug and dosage, but cannot specify the concentration ... that is predetermined by the pharmacy. While the drug fluid volume is documented in the patient’s chart by nursing, this intake is not easily controlled by physicians and can add to a patient’s daily fluid intake.” see fluid overload page 42

40 I AnesthesiologyNews.com

OCTOBER 2014

The following advertorial has been provided by Innovative Medical Products and is designed to support the advertisement presented below.

Q&A With Frank F. Humbles, MD, Conway Anesthesiology Associates, Conway, South Carolina Q. Dr. Humbles, you invented a device that is a great help to anesthesiologists. Please describe it and why you developed it. A. I conceived the Humbles LapWrap® Positioning Pad in a team effort with Innovative Medical Products, the leading manufacturer of patient positioning products.

Impetus for the device was born in part from the frustrations I heard from anesthesiologists, not to mention my own experience, that the conventional way of keeping patients’ arms by their sides during laparoscopic surgery—tucking bed sheets around and underneath the patient’s arms and torso—had several drawbacks. When sheets are used, visual access to the patient’s arms where leads and IV tubes

Enhanced Humbles LapWrap p Positioning Pad

are inserted is severely reduced if not entirely obscured. Pulling or cutting away some of the sheet material doesn’t work as it only increases the potential of patients’ arms falling off the OR table. The LapWrap, on the other hand, firmly secures patients’ arms by their sides during surgery with full visual access to the surgical team, and it’s also simple and easy to use. These are

Now even more secure with two-way performance! Anesthesiologist Frank Humbles, M.D. knows the importance of patient positioning. The Enhanced Humbles LapWrap®. • Positions patients arms while allowing easy access for leads and IV’s • Secures patient to OR table • Is dual sided for increased flexibility • Optional extensions can be attached for the extremely obese

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Q. How does the LapWrap provide visual access while still firmly securing the patient? A. The LapWrap is designed with a soft, comfortable, foam base pad with straps coming off the pad that capture the patient’s arms with hook and loop material that will not loosen or come apart as often happens with tucked sheets. These straps cover only part of the patient’s arm, therefore allowing full access to the exposed sections of the arm. The positioning pad has additional hook fasteners on the center cutout strap, providing more flexibility for securing the patient. This allows the positioner’s latex-free, foam straps, for example, to be placed between the operating table and the side rail, wrapped around the side rail and then back onto themselves for extra security. This added safety feature secures the patient directly to the OR table. The LapWrap thus ensures proper positioning and complete patient stability during the entire surgery, which is critical for the anesthesiologist who is ultimately responsible for this very important part of the surgical process.

Q. Are there other benefits from using the LapWrap? A. The LapWrap protects the patient’s neurological structures by preventing hyperextension of the elbow or other potential injuries to the shoulder or arm. In fact, the LapWrap was designed to meet AORN recommendations for positioning the patient in the perioperative setting and prevent tissue injury and ischemia that might be caused by tucking a patient’s arms at his or her side. Because the LapWrap firmly secures the patient throughout the entire surgical procedure, there is no cause for concern that a patient coming out of anesthesia will be able to violently flail about, as happens in some cases, or fall off the table. The LapWrap provides added security for the patient’s postoperative phase. The universal design of the LapWrap easily accommodates all size patients with an optional extension-fastening strap to secure even extremely obese patients. This universal design cuts down on hospital inventory costs.

Q. Besides the patient and surgical team, are there other stakeholders who benefit from the LapWrap?

Keep arms securely positioned. Designed to prevent tissue injury. Arms stay where you put them during the procedure.

Adaptable to all size patients. Use the optional extensions to secure the extremely obese.

The LapWrap® was designed to meet AORN recommendations in “Recommended practices for positioning the patient in the perioperative practice setting” to prevent tissue injury and ischemia that may be caused by tucking a patient’s arms at his or her side.

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A. The hospital or surgical center itself benefits. Because the LapWrap works so well in safely positioning and securing patients, it is solid insurance against accidents or mishaps reducing these risks. With the LapWrap, not only are there positive outcomes for the patient, surgeon and anesthesiologist, but also for the health care institution itself.

OCTOBER 2014

AnesthesiologyNews.com I 41

PRN

Immune Response to Major GI Surgery, Blood Transfusions Mapped Stockholm—Major gastrointestinal (GI) surgery promotes a specific gene expression pattern that upregulates the anti-inflammatoryy cytokine interleukin (IL)-10 while depressing proinflammatory immune pathways. Blood transfusions likely exacerbate this immune response, which also is associated with an increase in infectious complications. The finding raises the possibility that risk stratification for postoperative

Age, y

P Value

No Infection (n=75; 63%)

Infection (n=44; 37%)

Table. Patient Demographics

66 64 (range, (5659-75) 71)

0.19

Male, %

1.0

Diabetes, %

0.80

Current smokers, %

0.64

Smoking history, %

0.34

Cancer diagnosis, %

0.10

Preoperative 14 immunosuppression, %

1.0

Duration of operation, min

243 195 (range, (142176295) 313)

0.06

Endoscopic surgery, %

0.13

Planned post-op 77 ICU admission, %

0.22

ASA grade 3 or 4, %

1.0

–

Upper GI

–

Colorectal

–

HPB

–

HPB + colorectal

–

General + colorectal

0.84

Intraoperative 14 blood transfusion

0.17

Blood transfusion 23 in the last 24 h, %

0.02

In-hospital death, 1 %

1.0

By Surgical Specialty, n General

HPB, hepatopancreatobiliary

complications might use immunologic factors for prediction. Immune response to a major physiologic insult includes an early proinflammatory phase, known as the systemic inflammatory response syndrome, which is then followed by an

anti-inflammatory phase, known as the compensatory anti-inflammatory response syndrome (N Engl J Med 2003;348:138-150). Noting that the evidence supporting these two phases is scant and that more recent data have questioned its accuracy—especially

in patients with severe sepsis or blunt trauma (Nat Rev Immunol 2013;13:862-874)—a group of investigators from Barts and The London School of Medicine and Dentistry as well as Bloomsbury Institute of Intensive Care Medicine at University College, London, undertook an analysis of gene expression in patients having major GI surgery. All patients were aged over 45 years and were examined daily for the see immune page 42

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FLUID OVERLOAD

CONTINUED FROM PAGE 41

presence of infection (Table). Packed red blood cell (PRBC) transfusions were used because, unlike the effect of whole blood transfusions on postoperative infections, the immunologic consequence of leukocyte-depleted, PRBC transfusions is not well defined. The investigators, whose principal author was Paraskevi Fragkou, MBBS, hypothesized that major GI surgery will provoke an early postoperative immunosuppressive pattern of gene expression that will increase susceptibility to infectious complications. They also surmised that the transfusions themselves might contribute to immunosuppression in these surgical patients. Blood was collected preoperatively and at 24 and 48 hours postoperatively. Messenger RNA (mRNA) was extracted and mediators descriptive of specified T-cell pathways were quantified by polymerase chain reaction. The analysis of blood transfusion and immune pathways revealed a distinctive gene expression pattern. Foxp3, IL-12, IL-23, GATA3, RORgτ and tumor necrosis factor (TNF)α/IL-10

mRNA levels were lower in those receiving blood transfusions in the first 24 hours postoperatively. Foxp3, IL-23, RORgτ and TNFα/IL-10 mRNA levels were also lower at 48 hours postoperatively. IL-27 mRNA levels were unaffected by blood transfusion. The authors, who presented their results at Euroanaesthesia 2014 (abstracts 1AP4-2 and 6AP2-1), found that mortality was associated with higher IL-10 mRNA levels at 48 hours, lower levels of IL-23 mRNA at 24 and 48 hours, and lower levels of RORgτ mRNA at 48 hours. They concluded that patients receiving blood transfusions were more likely to develop infectious complications and pneumonia, and were more likely to die in hospital. They found that blood transfusions during and after major GI surgery were “associated with a distinctive gene expression pattern that includes a dramatic upregulation of the anti-inflammatoryy cytokine IL-10.” —James Prudden

CONTINUED FROM PAGE 39

When thinking about measures to prevent fluid overload, it’s important to remember that fluid is a drug with a therapeutic window, and that dosing rates should be individualized to the goals of therapy, the clinical scenario and the severity of illness, noted David Askenazi, MD, the director of the Pediatric and Infant Center for Acute Nephrology, Children’s of Alabama/University of Alabama at Birmingham. “It’s generally recognized that fluid resuscitation improves outcomes early in [patients with] shock,” said Dr. Askenazi, who was not involved in the Smiths Medical study. However, once the patient moves beyond that acute phase, caregivers need to keep in mind that “how we prescribe fluid can have a direct impact on excess fluid accumulation.” One way to keep that accumulation in check, he noted, is to concentrate medications and minimize IV fluids based on nutrition goals. It’s also important for physicians to “trend the patient’s cumulative

percent fluid balance,” Dr. Askenazi said. “This critical vital sign can quantitate the degree of fluid overload at one time point, and perhaps more importantly, provide insights to where the patient is heading.” Increasing Awareness The knowledge gained from the current study has helped define the burden of illness and the patient population most at risk (cardiac) from fluid overload, Dr. Child pointed out. Although further research is needed, she noted, the study could yield an immediate benefit—that is, increased awareness of the syndrome. If physicians become more proactive about fluid overload as a result, that change “holds promise to decrease length of stay and costs, and improve patient outcomes.” —Paul Bufano Dr. Child is a full-time employee of Smiths Medical, which manufactures the Medfusion syringe pump. Her co-authors are employees of Premier Healthcare Solutions and received funding from Smiths Medical for this study. Dr. Askenazi is on the speaker’s bureau of Baxter/Gambro Renal.

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PRN

Studying Neuropathic Pain, at a Snail’s Pace Research Could Pave Way for New Therapies

an a better understanding of the paralyzing venom of the marine cone snail lead to new synthetic versions of the substance that will treat certain forms of neuropathic pain? Although it is too soon to know, new research adding to what is already understood about conotoxins—peptides that give the venom its immobilizing properties and have been shown to have painkilling effects—may lead to development of neuropathic pain therapies in the future. A previous murine study by David Adams and other researchers at RMIT University, Melbourne, Victoria, Australia, showed that a specific conotoxin, Vc1.1, attacked neuropathic pain not by blocking voltage-gatedd calcium channels (VGCCs) as previously thought, but instead by directly blocking the channels through the use of γγ aminobutyric acid (GABA) receptors. The result is the inhibition of N-type CaV2.2 channels. The new research, published in the Journal of General Physiology by Dr. Adams and his colleagues (doi.1085/jgp.201411190) shows that Vc1.1 also inhibits RR type CaV2.3 channels. It has been suggested that these neuronal gated calcium channels play a role in pain signaling, but how this potentially happens has not been fully elucidated. Given that neuropathic pain is connected to changes in the way neurons transmit signals to one another, this may prove important, although the authors were quick to caution that “given the importance of these VGCCs in mediating normal neurotransmission, using them as a pharmacologic target

Schematic showing the proposed mechanism by which the cone snail venom Vc1.1 reduces pain sensation through indirect inhibition of R-type (CaV2.3) neuronal voltage-gated calcium channels. Source: Ann R. Rittenhouse, 2014

against neuropathic pain could potentially lead to undesirable side effects.” In an accompanying editorial, Ann R. Rittenhouse, PhD, University of Massachusetts Medical School, Worcester, expounded on the history of neuropathic pain therapy, and praised the new research.

2014;10.1085/jg.20141190). Dr. Rittenhouse stressed in her editorial that there is no way of knowing if Vc1.1 “will find its way into the pharmacological toolbox of treatments for “The insightful study by Berecki clinical neuropathic pain,” adding that et al demonstrates how the elabo- much research remains to be done. Still, rate details of signaling individual G she said, “who knew that such a simple protein-coupled receptors, in this case question of whether GABA modulates GABAB receptors, can give rise to a CaV2.3 currents would yield a new tarremarkable level of control over spe- get, ligand, and potential mechanism for cific members of the aCaV2 family,” treating neuropathic pain?” —Donald M. Pizzi wrote Dr. Rittenhouse (J ( Gen Physiol

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Overview of the Manageme Of Clostridium difficilee Infec Julia Garcia-Diaz, MD, MSc, FIDSA

costs nationwidd e, which indirectly Program Director, Infectious Disease Fellowship Program affect patient carre. Ochsner Clinic Scott demonstrate ed Associate Professor an average attrib b utUniversity of Queensland/Ochsner School able per-patient c ost Clinical Associate Professor of Medicine of $9,124 for CDI, Tulane University higher than cath heterNew Orleans, Louisiana associated urin n ary tract infections, which Arnab Ray, MD occurred at a higheer rate at the time of the study.9 Gastroenterologist This translates to approxOchsner Clinic imately $1 billion in extra New Orleans, Louisiana health care costs an nnually. Yet, others have estimaated the cost for Karla Rivera Rivera, MD CDI treatment to be as high as $4.9 billion in the acute care setting.10 Infectious Disease Fellow Although once thought to be strictly an Ochsner Clinic HAI, there is an increasing number of communityNew Orleans, Louisiana acquired C. difficile infections (CaCDI). Some lostridium difficile infection (CDI), a com- reports estimate that 30% to 40% of all CDI cases mon cause of infectious diarrhea, has become are CaCDI.11,12 Of note, Khanna et al demonstrated increasingly prevalent in the acute care set- that 22% of patients had no antibiotic exposure in ting.1 CDI is associated with increased morbidity the 90 days before the onset of CaCDI.12 and more recently with increased mortality,2,3 and Pathogenesis of Hypervirulent Strains it has surpassed methicillin-resistant StaphylococAs the rates of CDI increased in 2000, the North cus aureus (MRSA) as the leading cause of hospitalacquired infections (HAIs).2,4 American Pulsed Field type 1 strain (NAP1), or PCR CDI also increases hospital length of stay (LOS) ribotype 027 emerged; this strain was responsible and care costs. A well-known cause of antibiotic- for the Pittsburgh, Atlanta, and Montreal CDI outassociated diarrhea, it is estimated to account for breaks.2 This strain has increased production of the 15% to 25% of all diarrheal episodes.2 No longer only classic A (enterotoxin; 16-fold) and B (cytotoxin; associated with health care facilities, C. difficilee infec- 23-fold) toxins, and also an additional binary toxin currently under study; the latter is associated with tions are now an emerging threat in the community. a more severe diarrheal illness. It is also inherently Epidemiology resistant to fluoroquinolone (FQ) antibiotics, likely C. difficile is responsible for 12% of all HAIs in 10 secondary to their increasing and widespread use. Although FQs are not recommended for the treatgeographically diverse states. This translated to an estimated 80,400 cases of hospital-onset infections.5,6 ment of CDI, their use is an important epidemioThe Centers for Disease Control and Prevention logic risk factor for the spread within health care (CDC) national and state HAI progress report esti- facilities. Metronidazole (various) is the current recmated that there were 107,700 hospital-onset CDIs ommended choice for mild to moderate disease and nationwide in 2011 (the most recently reported data those with NAP1 infections see high failure rates,13 from 2012 showed a 2% decline in reported cases).4 thought to be secondary to the severity of the disease, Once thought to have a low attributable mortality low concentration levels in the fecal material, and rate, recent data has estimated CDI mortality to be poor tolerance. The NAP1 or ribotype 027 strains 6.9% at 30 days after diagnosis and 16.7% at 1 year.6 were associated with an increase in recurrences and The infection accounts for approximately 14,000 a more complicated clinical course, therefore higher deaths annually, and there was a 400% increase in morbidity and mortality rates.14 CDI-related deaths from 2000 to 2007, with most Another strain sharing hypervirulence is C. diffideaths occurring in older individuals.7,8 cilee PCR ribotype 078. Keel et al demonstrated that It is estimated that half of all CDIs occur in peo- this was the most commonly isolated strain in swine ple younger than age 65 years. However, 90% of and calves.15 Also frequently found in meat products, CDI-related deaths occur in those who are 65 and ribotype 078 is a possible risk factor for animal-toolder. Furthermore, about 25% show initial symp- human transmission, as well as a source for CaCDI.15 toms in the hospital versus 75% in nursing homes, In the United States, ribotype 078 is reported to doctors’ offices, and clinics; hence, 94% of all CDIs be the third most commonly isolated strain in are linked to medical care.8 Not only is this a concern CaCDI.16 It shares toxin A and B production as well for patient safety, it is also a concern for health care as a binary toxin.

In general, CaCDI may present with a more severe infection; patients are less likely to receive antibiotics and more likely to be younger and have a greater proportion of PCR ribotype 078 than those with CDI acquired in a hospital setting.17 More vigilance is required to detect these cases in the community which may not present with the traditional predisposing factors. Risk Factors As the leading cause of HAIs, there is a need for understanding risk factors associated with CDI. The CDC has confirmed advanced age (≥65) and antibiotic exposure as risk factors for CDI and CaCDI primary and recurrent infections.8 Multiple metaanalyses have confirmed older age, continued antibiotic exposure, and concomitant use of H2 blockers and proton pump inhibitors (PPIs) as risk factors for recurrent CDI as well as comorbid conditions, previous CDI recurrence, CDI acquired in the hospital setting, and prolonged hospital LOS.18 Although it is generally agreed that exposure to certain antibiotics (particularly FQs) increases the risk for CDIs, there has been some conflicting data as to what classes of drugs yield the greatest risk. Goorhuis et al, for example, found FQ treatment to be an independent risk factor for CDI due to ribotype 078. Ribotype 027 also had higher rates of infection in patients age 65 years and older who had been admitted to an inpatient hospital setting, had any underlying disorder, and had a history of exposure to antibiotic therapy.14 However, although Brown et al found use of tetracyclines and penicillins related to lower risk for CDI,18 Keessen et al found that clindamycin (various) exposure was also a major risk factor, in addition to exposure to cephalosporins and FQs, specifically for CDI due to ribotype 078.19 Yet another study showed that in addition to the aforementioned risk factors, hospital LOS was a risk factor see C. diff page 46

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PRN Treatment Approaches In general, strategies for treatment for colonization with C. difficile lead- should be tailored according to the ing to CDI.20 Additional studies have patient’s age and underlying comorbidhighlighted treatment with PPIs as a ities (Table 1). novel risk factor for CaCDI in miliFDA-Approved Options tary active duty personnel (this study Metronidazole and Vancomycin also revealed higher morbidity and mortality rates among older individuMetronidazole is a nitroimidazole als plus those once considered low-risk with broad activity against anaerogroups for CaCDI, including commu- bic bacteria, including C. difficile. It is nity dwellers, pregnant women, and currently recommended as the drug of children).21 choice for mild to moderate CDI.22

C. DIFF

CONTINUED FROM PAGE 44

Vancomycin is a glycopeptide that is not absorbed when given orally. Vancomycin is currently recommended for the first episode of moderate to severe CDI or in cases of metronidazole therapy failure or potentially lifethreateningg CDI.22 Although early studies demonstrated similar efficacy between the 2 agents,23 studies since 2004 have shown an increased rate of treatment failures associated with metronidazole (16%-38%), whereas vancomycin

failures remained the same (1%-6%).24 Zar et al was the first study to compare the drugs directly, in a prospective manner, in the treatment of C. difficileassociated diarrhea (CDAD). Among the patients with mild CDAD, treatment with metronidazole or vancomycin resulted in clinical cure in 90% and 98% of the patients, respectively (P=0.36). The critical results from this study were that among the patients with severe CDAD, clinical cure was 76% for metronidazole and 97% for vancomycin (P=0.02). Recurrence rates were similar (15% and 14%) between the 2 groups.24 Oral metronidazole is completely absorbed in the gastrointestinal tract but fecal penetration is poor, leading to low luminal concentrations (range 0.8-24 mcg/g; the susceptible range is 0.2-2.0 mcg/mL). Additionally, IV metronidazole has been shown inferior (P<0.001) to both oral metronidazole and oral vancomycin.25 Fidaxomicin

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Fidaxomicin (FDX; Dificid, Cubist) is the most recent CDI treatment to receive FDA approval. It is a macrocyclic antibiotic that is highly active against C. difficile (MIC90, 0.25 mcg/ mL), including the epidemic strain. Results from 8 in vitro studies comprising 1,323 C. difficile isolates showed the minimum inhibitory concentration (MIC) range of FDX to be greater than 0.001 to 1 mcg/mL, with a MIC90 of 0.5 mcg/mL. No resistant isolate has been reported, although a single strain was recovered from a cured patient who had an elevated MIC of 16 mcg/mL at the time of recurrence.26 In the pivotal trial of FDX versus vancomycin, clinical cure rates were similar and FDX was noninferior to vancomycin (92.1% and 89.8%, respectively). However, patients treated with FDX had lower recurrence (13.3% vs 24%; P=0.004).27 Additionally, data from the 2 Phase III trials showed that FDX, when administered concomitantly with other antibiotics, has a higher cure rate (46 of 51 [90.2%]) than vancomycin (33 of 45 [73.3%]; P=0.031) and that overall treatment with FDX compared with vancomycin was associated with lower recurrence rates (16.9% vs 29.2%; P=0.048).28 The lower recurrence rates associated with FDX may be due to the drug’s ability to preserve the normal gut microbiome and completely resolve the underlying CDI pathogen, or both. A randomized clinical trial assessed the microflora-sparingg properties of FDX

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AnesthesiologyNews.com I 47

PRN by examining fecal samples for quantitative cultures for C. difficilee and cytotoxin B fecal filtrate concentrations against normal microbiota. FDX and vancomycin rapidly killed C. difficile and neutralized toxin; however, FDX preserved the microbiome during and after CDI treatment.27

including 167 of 205 (81.5%) with epidemic clone (BI/NAP1) isolates (P<0.001). Of 8 patients who were exposed to rifamycin, 7 had rifampinresistant C. difficilee compared with 166 of 462 unexposed patients (relative risk, 2.4).30 In an open-label trial, 8 of 13 enrolled patients received rifaximin; all patients reported symptom resoOther Options lution; 7 had no relapse at follow-up Because results with currently avail- (median 162 days).31 able treatments have been suboptimal— Overall, more attention has been with high rates of recurrence—new given to use of rifaximin as a “chaser” modalities and treatments have been pursued.

rather than as first-line therapy. In one study, for example, patients were given rifaximin versus placebo immediately after finishing standard antiCDI antibiotics. CDI recurrence was lower in the rifaximin arm versus placebo (15% vs 31%; P=0.11).32 A randomized placebo-controlled trial testing the hypothesis that rifaximin given in a decreasing dose over 4 weeks after successful CDI treatment will reduce relapse is currently ongoing.

Nitazoxanide

Nitazoxanide (NTZ) is a synthetic nitrothiazole benzamide approved for the treatment of Cryptosporidium and Giardia species. It has excellent in vitro activity against C. difficile with an MIC90 of 0.125 mcg/mL. A prospective, randomized, double-blind study compared NTZ (7 and 10 days) with metronidazole (10 days) in hospitalized patients with C. difficile colitis. Response rate at 1 month for see C. diff page 48

Rifaximin

Rifaximin (Xifaxan, Salix) is a semisynthetic derivative of rifamycin approved for the treatment of traveler’s diarrhea; it is also used off label for irritable bowel syndrome and hepatic encephalopathy. It has in vitro activity against aerobic and anaerobic grampositive and gram-negative bacteria. After 3 days of therapy, the fecal level of the drug reaches 8,000 mcg/g.29 C. difficile resistance to rifampin (a surrogate for rifaximin) has been observed in several studies. The prevalence of rifampin resistance among 470 C. difficile isolates from a large teaching hospital was analyzed and was observed in 173 patients (36.8%), Table 1. Treatment Options for Clostridium difficile e Infection FDA-Approved Metronidazole Vancomycin Fidaxomicin (Dificid, Cubist)

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LMASUPREME.COM REFERENCES FERENCES 1. Belena J.M. et al. Journal of Clinical Anesthesia 2011; 23:456-460. | 2. Roiss M. et al. Poster presented at The American Association of Anesthesiologists Annual Meeting 15th -19th, Oct. 2011, Chicago. | 3. Sharma V. et al. BJA 2010; 105(2): 228-232. | 4. Whitacre W. et al. AANA Journal 2014; 82 (2): 101-107. | 5. Abdi W. et al. Acta Anaethesiol Scand. 2010; 54 (2): 141-146. | 6. Bernardini A. et al. Anesthesia 2009; 64: 1289-1294. | 7. Verghese C. et al. Anesthesia and Analgesia 1996; 82: 129-133. | 8. Tretiak S. Anethesiology News 2009. | 9. Viernes D. et al. Anesthesiology News 2010; 9-13. | 10. Verghese C. et al. BJA 2008; 101 (3): 405-410. | 11. Jagannathan N. et al. Pediatric Anesthesia 2012; 22:759-764. | 12. Jagannathan N. et al Anesthesia 2012; 67(2): 139-144. | 13. Ferson D. et al. Anesthesiology 2007; 107:A592.

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in this difficult-to-treat patient popu- for severe, refractory CDI in critically lation.34 No clinical trials are currently ill patients have reported some success. A prospective clinical trial assessing the metronidazole was 57.6% compared ongoing. safety of tigecycline added to standard with 65.8% (7 days) and 74.3% (10 Tigecycline oral therapy (vancomycin or metrodays; P=0.34) for NTZ.33 In another study, patients who had Tigecycline (Tygacil, Pfizer) has nidazole) was completed recently and failed metronidazole treatment were activity against a broad spectrum of results are pending. given NTZ; 74% responded, although gram-positive and gram-negative aerNew Drugs in Development 7 later had recurrent disease (54% obes and anaerobes, including C. difLFF571 cure rate). Three who initially failed ficile (MIC90 of 0.06-0.25 mcg/mL).35 and 1 who had recurrent disease were Multiple case reports and small case LFF571 (Novartis) is a novel semiretreated with NTZ and responded, series using IV tigecycline as adjunc- synthetic thiopeptide antibiotic with yielding an aggregate cure rate of 66% tive therapy to other treatment options potent activity against a variety of CONTINUED FROM PAGE 47

gram-positive pathogens, including C. difficile. In a hamster model, LFF571 was more efficacious and had fewer recurrences than vancomycin.36 A study investigating the safety and pharmacokinetics of single- and multipleascending oral doses in healthy individuals reported that the drug was generally safe and well tolerated.37 A Phase II study of the safety and efficacy of multiple daily dosing of oral LFF571 in patients with moderate CDIs was completed recently and data is pending. Surotomycin

Surotomycin (CB-183,315, Cubist) is an orally available lipopeptide antibiotic that is structurally related to daptomycin.38 Surotomycin has shown good potency against C. difficilee isolates (including 027/NAP1/BI isolates) as well as those with high MICs to metronidazole, moxifloxacin, and vancomycin. It lacks activity against Enterobacteriaceae and species of the Bacteroidess group (MIC90 >8,192 mcg/mL); this suggests that this compound will minimize disruption and lead to rapid recovery of the normal gut flora.39,40 Surotomycin has successfully completed a Phase II trial in patients with CDI. It also showed better sustained cure rates than vancomycin as well as reduction and delay in recurrence (17% for surotomycin vs 36% vancomycin) of CDAD episodes.38 Phase III trials are ongoing. SMT 19969

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SMT 19969 (Summit) is a bisbenzimidazole tetrahydrate compound that has demonstrated potent activity against C. difficilee isolates with MIC90 values 2-, 8-, and 16-fold lower than FDX, metronidazole, and vancomycin, respectively. SMT 19969 has shown limited activity against gram-positive and gram-negative anaerobes, including Bacteroides species, Bifidobacterium species, and others (with the exception of Clostridia). This suggests that SMT 19969 would have minimal disruption in the gut flora and preservation of the normal gut microbiome.41,42 SMT 19969 was safe and well tolerated at all dosages in the recent Phase I trial.41 A Phase II trial is ongoing. Cadazolid

Cadazolid (CDZ; ACT-179811, Actelion) is a new quinolonyl-oxazolidinone with structural elements of the oxazolidinone as well as the quinolone class. It is a strong inhibitor of C. difficile protein synthesis that leads to the suppression of toxin and spore formation.

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AnesthesiologyNews.com I 49

PRN A recent study showed CDZ was active against all (including linezolidand moxifloxacin-resistant) C. difficile strains (MIC90 0.125, range 0.03-0.25 mg/L). The CDZ geometric mean MIC was 152-, 16-, 9-, and 7-fold lower than those of moxifloxacin, linezolid, metronidazole, and vancomycin, respectively. CDZ levels persisted at 50- to 100-fold supra MIC for 14 days after dosing. Inhibition of gut microflora was limited with the exception of bifidobacteria; Bacteroides fragilis group and Lactobacillus species counts were not affected.43 In Phase I trials, CDZ was well tolerated and systemic exposure was low. Most of the compound was recovered unchanged in the feces, resulting in high concentrations in the colon.44 A Phase II study evaluated the efficacy, safety, and tolerability of CDZ in patients with CDAD. The results of this study indicate that the cure rates for all twice-dailyy doses of CDZ (76.5% [250 mg]; 80% [500 mg]; 68.4% [1,000 mg]) were similar to or better than those for vancomycin (68.2%). Recurrence rates were lower for all twice-dailyy doses of CDZ (18.2% [250 mg]; 25% [500 mg]; 22.2% [1,000 mg]) compared with vancomycin (50%).45 Phase III clinical trials are underway.

CamSA

Cholate meta-benzene sulfonic derivative (CamSA) is a bile salt analog that inhibits C. difficile spore germination in vitro. Howerton et al infected mice with massive inocula of C. difficile spores and treated them with different concentrations of CamSA. A single 50-mg/kg dose of CamSA prevented CDI without any toxicity. This is a novel approach and would add to the treatment of CDI without compromising the microbiota in these

patients.50 CamSA’s in vitro stability, or vancomycin. This clinical trial distribution, and cytotoxicity are cur- showed significant reduction in the rently being characterized. rate of recurrence of C. difficile among patients treated with the mAbs (7% vs Monoclonal Antibodies 25%; P<0.001). The recurrence rates MK-3415A (Merck) is a combina- among patients with the epidemic BI/ tion of monoclonal antibodies (mAbs) NAP1/027 strain were 8% for the to C. difficile toxin A (MKK 3415) and antibody group and 32% for the platoxin B (MKK 6072). A Phase II study cebo group (P=0.06); among patients showed favorable results when C. dif- with more than one previous episode ficile human mAbs were administered of C. difficile infection, recurrence to patients with C. difficile infection rates were 7% and 38%, respectively after being treated with metronidazole see C. diff page 50

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Oritavancin (ORI; LY333328, The Medicines Company) is a lipoglycopeptide with activity against C. difficile. In vitro, it was found to be at least 4-fold more potent than vancomycin against C. difficile strains tested.46 When tested for the treatment of PCR ribotype 027 in a human gut model, it was found that both ORI and vancomycin were effective in treating CDI, but only ORI appeared active against spore forms of C. difficile. Overall, ORI therapy may be more effective in treating CDI than vancomycin because it may prevent recrudescence of C. difficilee spores.47 In a simulated CDI human gut model, Chilton et al demonstrated that ORI short-course therapy (4-day) might be an effective CDI treatment.48 More recently this same group showed that ORI might adhere to spores, potentially causing early inhibition of germinated cells and preventing subsequent vegetative outgrowth and spore recovery. Again, this may prevent some recurrences of CDI that are due to germination of residual spores after antibiotic therapy.49 Despite all the information thus far available, no clinical trials are ongoing.

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The landmark study published by van Nood et al randomized patients (P=0.006).51 Phase III trials are with recurrent CDI to FMT via nasoongoing. duodenal infusion, vancomycin, and vancomycin with bowel lavage. The study was halted at interim analysis Biotherapeutics Fecal Microbiota Transplantation because the FMT arm showed a supeThere has been a lot of attention sur- rior success rate (81%) compared with rounding the success of fecal microbiota the vancomycin (31%) and vancomytransplantation (FMT) in the treatment cin with bowel lavage arms (23%). Two of recurrent CDI. To date, numerous of the 3 treatment failures in the FMT studies have shown superior efficacy of arm resolved with a second infusion FMT over traditional antibiotics. from a different donor, bringing the CONTINUED FROM PAGE 49

overall success rate to 93.75%.52 This is consistent with meta-analyses of the success rate of FMT for CDI worldwide, which is 91%, regardless of the route of administration.53 Additionally, after the donor-feces infusion, patients showed an increased fecal bacterial diversity very much similar to the donors (Figure 2). In 8 patients from whom samples were available, the diversity of fecal microbiota could not be distinguished from that of the donors during the follow-up period.52

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319.248.6757 | 800.445.6741 | WWW.CIVCO.COM Accurate Guidance. Confident Outcomes.

1. Gupta R, Lane J, Allen B, Shi Y, Schildcrout J. “Improving Needle Visualization by Novice Residents During an In-Plane Ultrasound Nerve Block Simulation Using an In-Plane Multi-Angle Needle Guide.” Pain Medicine. 14.10 (2013): 1600-1607. 2. Whittaker S, Lethbridge G, Kim C, Keon Z, Ng I. “An Ultrasound Needle Insertion Guide in a Porcine Phantom Model.” Journal of the Association of Anaesthetlists of Great Britian and Ireland – Anaesthesia. 68. 8 (2013): 826-829. 3. Ball R, Scouras N, Orebaugh S, Wilde J, Sakai T. “Randomized Prospective Observational Simulation Study Comparing Residents Needle-Guided vs. Free-hand Ultrasound Techniques for Central Veneous Catheter Access.” British Journal of Anaesthesia. 108.1 (2011): 72-79.

Although concerns have been raised regarding the safety of FMT, numerous literature reviews have reported no serious adverse events (AEs) or infectious transmissions directly attributable to FMT.54 There are, however, legitimate concerns regarding the safety of FMT in patients with compromised immune systems. Immunocompromised patients seem to be at increased risk for developing recurrent CDI due to repeated antibiotic treatment, prolonged hospital LOS, and decreased ability to eradicate the infection. A multicenter retrospective study of FMT in 75 immunocompromised adults found similar efficacy (89%) to other studies and no infectious complications directly attributable to FMT, with follow-up to 11 months. Patients included were solid organ transplants, HIV/AIDS, patients undergoing chemotherapy, and those receiving immunosuppressive treatment for inflammatory bowel disease.55 Cost is also an issue with FMT. An analysis of FMT versus vancomycin for recurrent CDI found that FMT had an incremental cost-effectiveness ratio of $17,016 relative to vancomycin. More specifically, FMT via colonoscopy was felt to be the most cost-effective route of administration compared with duodenal infusion or enema.56 FMT has proven to be safe and efficacious, but it remains a timeconsumingg and nonstandard process. Although the major gastrointestinal societies and the Infectious Diseases Society of America released a joint statement on donor screening guidelines in July 2013, the recommendations are not evidence-based.57 Finding and screening a donor can be a time-consuming, expensive, and embarrassing process for the patient. In the inpatient setting with a critically ill patient, there is not always time to properly identify and screen a donor. Multiple techniques have been developed to try to work around these inherent difficulties in an attempt to standardize and speed up treatment, including frozen stool protocols and open-access stool banks. In frozen stool protocols, donor stool is blended, filtered, and then processed with glycerol before freezing at –80°C for later usage. Before use in FMT, the frozen slurry is thawed in an ice bath. A series of 43 patients treated with the frozen protocol showed an 86% treatment success rate, but it should be noted that 30% of the patients had underlying inflammatory bowel disease.58 More recently, Youngster et al conducted an open-label,

OCTOBER 2014

AnesthesiologyNews.com I 51

PRN Table 2. Clostridium difficilee Vaccines and Immunologics Product

Antigen

Formulation

Clinically trials

ACAM-CDIFF Vaccine (Sanofi Pasteur)

Formalin inactivated toxins A and B from VPI 10463

± alum-adjuvant IM injections 0, 7, and 28-30

Phase I volunteer safety and immune response Phase II for CDI Phase II for CDI prevention (ongoing)

Intercell IC84 Vaccine

Recombinant fusion protein of toxin A and B binding regions

± aluminum salt adjuvant IM injection days 0, 7, and 21

Phase I volunteer safety and immune response

Clostridium difficile e vaccine (Pfizer)

Molecularly and chemically inactivated toxins A and B

Vaccine with or without unnamed adjuvant, 3 ascending doses

Phase I volunteer safety and immune response

Monoclonal antibodies: MK-6072 & MK-3415A (Merck)

Monoclonals targeting toxin binding epitopes

Human monoclonal antibody IV

Two Phase III clinical trials

randomized, controlled pilot study using frozen inoculum from unrelated donors.59 Overall cure rate was 90% at 8 weeks. North York General Hospital in Toronto, Canada, has begun offering patients the option to bank their own stool before hospital admission in the event they become infected with hospital-acquired CDI. This approach offers the advantages of not requiring a donor or screening testing. This program is a pilot study and no efficacy data is available yet.60 Open Biome, meanwhile, is a nonprofit “stool bank” developed at Massachusetts Institute of Technology in Cambridge. A selected few “healthy donors” have undergone extensive screening for common infectious diseases beyond the consensus screening guidelines, and serially collected and frozen the stool, making it commercially available for hospitals. Anecdotal reports thus far have been positive, and data collection is currently underway to publish safety and efficacy data. There is concern from the FDA regarding oversight and regulation of “stool banks,” although Open Biome operates under an institutional review board. The ultimate goal is to remove the “fecal” from FMT, and this may be accomplished via stool substitute transplant therapy. Queen’s University in Canada has successfully reproduced 33 purified intestinal bacterial cultures under anaerobic conditions into a synthetic mixture, which was then instilled into the colons of 2 patients with recurrent CDI due to a hypervirulent ribotype 078 strain. Both patients had resumption of normal bowel habits within 3 days with durability of cure at 6 months.61 The “holy grail” of FMT is to develop a pill that would reconstitute the colonic microbiome and eradicate C. difficile. Louie presented a pilot series of 31 patients treated with 24 to 34 pills of fecally derived bacteria

Why Risk VTE From Low Antithrombin (AT) Levels? AT Level

61-75 IU/dL

45-60 IU/dL

Unprovoked* VTE Risk

6x Risk

23x Risk

*Data reflect events that occurred in the absence of transient risk factors (ie, surgery, trauma, prolonged bed rest [>1 week], pregnancy/ ncy/ puerperium, and combined oral contraceptive use). Risk assessed in comparison to patients with normal AT levels (or levels >100 IU/dL).2

Do You Test for Hereditary AT Deficiency? ncy?

FOR PATIENTS IENTS WITH HER HEREDITARY ANTITHROMBIN OMBIN DEFICIENCY1 • Provides predictable amounts of antithrombin • Replaces antithrombin normally present in the body • In clinical use for over 20 years Important Safety Information Thrombate III® (antithrombin III [human]) is indicated for the treatment of patients with hereditary antithrombin deficiency in connection with surgical or obstetrical procedures or when they suffer from thromboembolism. In clinical studies, the most common adverse events were dizziness, chest discomfort, nausea, and dysgeusia. The anticoagulant effect of heparin is enhanced by concurrent treatment with Thrombate III in patients with hereditary AT-III deficiency. Thus, in order to avoid bleeding, reduced dosage of heparin is recommended during treatment with Thrombate III. Thrombate III is made from human plasma. Plasma products carry a risk of transmitting infectious agents, such as viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent, despite steps designed to reduce this risk. No cases of transmission of viral disease or CJD have ever been identified for Thrombate III. Please see brief summary of Thrombate III complete Prescribing Information on adjacent page. References: 1 THROMBATE III® (antithrombin III [human]) Prescribing Information. Grifols. 2 Bucciarelli P, Passamonti SM. Biguzzi E, et al. Low borderline plasma levels of antithrombin, protein C and protein S are risk factors for venous thromboembolism. J Thromb Haemost. 2012;10:1783-1791. © 2014 Grifols Inc.

August 2014

TH60-0814

see C. diff page 52 Grifols Therapeutics Inc. 8368 US Hwy 70 West, Clayton, North Carolina 27520 - USA Tel. 00 1 919 553 5011 www.grifols.com

52 I AnesthesiologyNews.com

OCTOBER 2014

PRN CONTINUED FROM PAGE 51

covered in gelatin to survive gastric acid and deliver the contents to the colon; 30 of 31 patients enrolled were cured with no significant AEs noted.62 VP20621

VP20621 (ViroPharma), spores of nontoxigenic C. difficile (NTCD) strain M3, have been shown to be protective against challenge with toxigenic strains in hamsters.63 Human

administration and colonization by VP20621 may prevent primary CDI or recurrent CDI. Phase I clinical safety testing was completed in 2010. Healthy adults received single or multiple doses of an oral suspension of VP20621 or placebo. All doses were well tolerated, and no serious AEs were reported and no discontinuation due to AEs occurred. Participants did not experience diarrhea or change in bowel habits. Persistent colonization with VP20621 was

BRIEF SUMMARY CONSULT PACKAGE INSERT FOR FULL PRESCRIBING INFORMATION FOR INTRAVENOUS USE ONLY DESCRIPTION Antithrombin III (Human), THROMBATE III® is a sterile, nonpyrogenic, stable, lyophilized preparation of purified human antithrombin III (ATIII). THROMBATE III is prepared from pooled units of human plasma from normal donors by modifications and refinements of the cold ethanol method of Cohn. When reconstituted with Sterile Water for Injection, USP, THROMBATE III has a pH of 6.0–7.5, a sodium content of 110–210 mEq/L, a chloride content of 110–210 mEq/L, an alanine content of 0.075–0.125 M, and a heparin content of not more than 0.1 IU heparin/IU ATIII. THROMBATE III contains no preservative and must be administered by the intravenous route. Each vial of THROMBATE III contains the labeled amount of antithrombin III in international units (IU) per vial. The potency assignment has been determined with a standard calibrated against a World Health Organization (WHO) antithrombin III reference preparation. The capacity of the THROMBATE III manufacturing process to remove and/or inactivate enveloped and non-enveloped viruses has been validated by laboratory spiking studies on a scaled down process model using a wide range of viruses with diverse physicochemical properties. There are two dedicated virus inactivation/removal steps included in the THROMBATE III manufacturing process: a heat treatment step at 60°C ± 0.5°C for not less than 10 hours for virus inactivation and a nanofiltration step for effective removal of viruses as small as 18 nm. The manufacturing process was also investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered as a model for the vCJD and CJD agents. An individual production step in the THROMBATE III manufacturing process has been shown to decrease TSE infectivity of that experimental model agent. The TSE reduction step is the Effluent I to Effluent II + III fractionation step (6.0 log10). These studies provide reasonable assurance that low levels of CJD/vCJD agent infectivity, if present in the starting material, would be removed.

CLINICAL PHARMACOLOGY Antithrombin III, an alpha2-glycoprotein of molecular weight 58,000, is normally present in human plasma at a concentration of approximately 12.5 mg/dL and is the major plasma inhibitor of thrombin. Inactivation of thrombin by ATIII occurs by formation of a covalent bond resulting in an inactive 1:1 stoichiometric complex between the two, involving an interaction of the active serine of thrombin and an arginine reactive site on ATIII. ATIII is also capable of inactivating other components of the coagulation cascade including factors IXa, Xa, XIa, and XIIa, as well as plasmin. The neutralization rate of serine proteases by ATIII proceeds slowly in the absence of heparin, but is greatly accelerated in the presence of heparin. As the therapeutic antithrombotic effect in vivo of heparin is mediated by ATIII, heparin is ineffective in the absence or near absence of ATIII. The prevalence of the hereditary deficiency of ATIII is estimated to be one per 500 to 5000 in the general population. The pattern of inheritance is autosomal dominant. In affected individuals, spontaneous episodes of thrombosis and pulmonary embolism may be associated with ATIII levels of 40%–60% of normal. These episodes usually appear after the age of 20, the risk increasing with age and in association with surgery, pregnancy and delivery. The frequency of thromboembolic events in hereditary ATIII deficiency during pregnancy has been reported to be 70%, and several studies of the beneficial use of Antithrombin III (Human) concentrates during pregnancy in women with hereditary deficiency have been reported. In many cases, however, no precipitating factor can be identified for venous thrombosis or pulmonary embolism. Greater than 85% of individuals with hereditary ATIII deficiency have had at least one thrombotic episode by the age of 50 years. In about 60% of patients thrombosis is recurrent. Clinical signs of pulmonary embolism occur in 40% of affected individuals. In some individuals, treatment with oral anticoagulants leads to an increase of the endogenous levels of ATIII, and treatment with oral anticoagulants may be effective in the prevention of thrombosis in such individuals. In clinical studies of THROMBATE III conducted in 10 asymptomatic subjects with hereditary deficiency of ATIII, the mean in vivo recovery of ATIII was 1.6% per unit per kg administered based on immunologic ATIII assays, and 1.4% per unit per kg administered based on functional ATIII assays. The mean 50% disappearance time (the time to fall to 50% of the peak plasma level following an initial administration) was approximately 22 hours and the biologic half-life was 2.5 days based on immunologic assays and 3.8 days based on functional assays of ATIII. These values are similar to the half-life for radiolabeled Antithrombin III (Human) reported in the literature of 2.8–4.8 days.

detected in stools on days 21 to 28 in 44% of participants. VP20621 was able to colonize the gastrointestinal tracts of those pretreated with vancomycin.64 A Phase II clinical trial in recurrent CDI is underway. Probiotics

Vaccines A Cochrane meta-analysis of 31 randomized studies and 4,492 parThe only currently available antiticipants concluded that taking probi- body treatment for CDI is pooled otics with antibiotics reduced the risk intravenous immunoglobulin (IVIG); for developing CDAD by 64%. The IVIG preparations contain neutralizing levels of IgG antibody to toxin A and B. To date, no studies have provided conclusive evidence for any clinical by immuno assays. The latter does not detect all hereditary ATIII deficiencies. benefit of IVIG. Active immunization The ATIII level in neonates of parents with hereditary ATIII deficiency should be measured immediately after birth. (Fatal neonatal thromboembolism, such as aortic thrombi in children of women with hereditary antithrombin III rather than passive is appealing, as deficiency, has been reported.) this would confer durable protection Plasma levels of ATIII are lower in neonates than adults, averaging approximately 60% in normal term infants. ATIII levels in premature infants may be much lower. Low plasma ATIII levels, especially in a premature infant, therefore, do against CDI. Vaccines for CDI have not necessarily indicate hereditary deficiency. It is recommended that testing and treatment with THROMBATE III of been in development for more than neonates be discussed with an expert on coagulation. CONTRAINDICATIONS 2 decades. Torres et al showed that a None known. formalin-inactivated C. difficile culture WARNINGS filtrate protected hamsters when given Because THROMBATE III is made from human plasma, it may carry a risk of transmitting infectious agents, by nasal, intraperitoneal, and subcutae.g. viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent. No cases of transmission of viral diseases or CJD have ever been identified for THROMBATE III. Inform patients that THROMBATE III is made neous routes.66 from human plasma and may contain infectious agents that can cause disease. While the risk that THROMBATE III can transmit an infectious agent has been reduced by screening plasma donors for prior Currently there are 3 vaccines exposure, testing donated plasma, and by inactivating or removing pathogens during manufacturing, in clinical development. ACAMpatients should report any symptoms that concern them. ALL infections thought by a physician possibly to have been transmitted by this product should be reported by the physician or other healthcare provider to CDIFF (Sanofi-Pasteur) is a mixture Grifols Therapeutics Inc. [1-800-520-2807]. of formalin-inactivated toxin A and B The anticoagulant effect of heparin is enhanced by concurrent treatment with THROMBATE III in patients with hereditary ATIII deficiency. Thus, in order to avoid bleeding, reduced dosage of heparin is recommended during that is given 3 times IM. The vaccine treatment with THROMBATE III. has been shown to be safe, well tolPRECAUTIONS erated, and immunogenic in healthy General 1. Administer within 3 hours after reconstitution. Do not refrigerate after reconstitution. adults. Phase II trials have been com2. Administer only by the intravenous route. pleted in the therapeutic setting and 3. THROMBATE III, once reconstituted, should be given alone, without mixing with other agents or diluting solutions. additional trials in the prophylactic set4. Product administration and handling of the needles must be done with caution. Percutaneous ting are ongoing. Due to the fact that puncture with a needle contaminated with blood can transmit infectious virus including HIV (AIDS) and hepatitis. Obtain immediate medical attention if injury occurs. the vaccine addresses an important Place needles in sharps container after single use. Discard all equipment including any reconstituted unmet medical need, ACAM-CDIFF THROMBATE III product in accordance with biohazard procedures. has been fast-tracked by the FDA.67 The diagnosis of hereditary ATIII deficiency should be based on a clear family history of venous thrombosis as well as decreased plasma ATIII levels, and the exclusion of acquired deficiency. A second injectable vaccine, IC84, Laboratory Tests is a subunit recombinant protein vacIt is recommended that ATIII plasma levels be monitored during the treatment period. Functional levels of ATIII in plasma may be measured by amidolytic assays using chromogenic substrates or by clotting assays. cine consisting of 2 truncated toxDrug Interactions ins A and B from C. difficile. IC84 has The anticoagulant effect of heparin is enhanced by concurrent treatment with THROMBATE III in patients with undergone Phase I safety and immunohereditary ATIII deficiency. Thus, in order to avoid bleeding, reduced dosage of heparin is recommended during treatment with THROMBATE III. genicity testing in volunteer subjects Pregnancy Category B

Reproduction studies have been performed in rats and rabbits at doses up to four times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to THROMBATE III. It is not known whether THROMBATE III can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Pediatric Use Safety and effectiveness in the pediatric population have not been established. The ATIII level in neonates of parents with hereditary ATIII deficiency should be measured immediately after birth. (Fatal neonatal thromboembolism, such as aortic thrombi in children of women with hereditary antithrombin III deficiency, has been reported.) Plasma levels of ATIII are lower in neonates than adults, averaging approximately 60% in normal term infants. ATIII levels in premature infants may be much lower. Low plasma ATIII levels, especially in a premature infant, therefore, do not necessarily indicate hereditary deficiency. It is recommended that testing and treatment with THROMBATE III of neonates be discussed with an expert on coagulation.

ADVERSE REACTIONS

In clinical studies of THROMBATE III, none of the 13 patients with hereditary ATIII deficiency and histories of thromboembolism treated prophylactically on 16 separate occasions with THROMBATE III for high thrombotic risk situations (11 surgical procedures, 5 deliveries) developed a thrombotic complication. Heparin was also administered in 3 of the 11 surgical procedures. Eight patients with hereditary ATIII deficiency were treated therapeutically with THROMBATE III as well as heparin for major thrombotic or thromboembolic complications, with seven patients recovering. Treatment with THROMBATE III reversed heparin resistance in two patients with hereditary ATIII deficiency being treated for thrombosis or thrombo embolism.

In clinical studies involving THROMBATE III, adverse reactions were reported in association with 17 of the 340 infusions during the clinical studies. Included were dizziness (8), chest discomfort (3), nausea (3), dysgeusia (3), chills (2), pain (cramps) (2), dyspnoea (1), chest pain (1), vision blurred (1), intestinal dilatation (1), urticaria (1), pyrexia (1), and wound secretion and hematoma (1). If adverse reactions are experienced, the infusion rate should be decreased, or if indicated, the infusion should be interrupted until symptoms abate.

During clinical investigation of THROMBATE III, none of 12 subjects monitored for a median of 8 months (range 2–19 months) after receiving THROMBATE III became antibody positive to human immunodeficiency virus (HIV-1). None of 14 subjects monitored for ≥ 3 months demonstrated any evidence of hepatitis, either non-A, non-B hepatitis or hepatitis B.

Rx only U.S. federal law prohibits dispensing without prescription.

THROMBATE III is indicated for the treatment of patients with hereditary antithrombin III deficiency in connection with surgical or obstetrical procedures or when they suffer from thromboembolism. Subjects with ATIII deficiency should be informed about the risk of thrombosis in connection with pregnancy and surgery and about the inheritance of the disease.

ATIII in plasma may be measured by amidolytic assays using synthetic chromogenic substrates, by clotting assays, or

250

200

150

100

Donors

CAUTION

INDICATIONS AND USAGE

The diagnosis of hereditary antithrombin III (ATIII) deficiency should be based on a clear family history of venous thrombosis as well as decreased plasma ATIII levels, and the exclusion of acquired deficiency.

use of probiotics appeared to be safe and effective in patients who were not immunocompromised.65 There are a number of clinical trials currently ongoing to determine the role of probiotics in the prevention of CDI and/ or CDI recurrence.

Simpson’s Reciprocal Index

C. DIFF

Patients after infusion

Figure 2. Microbial diversity in patients before and after infusion of donor feces compared with diversity in healthy donors. Adapted from reference 52.

Grifols Therapeutics Inc. Research Triangle Park, NC 27709 USA U.S. License No. 1871

Patients before infusion

OCTOBER 2014

AnesthesiologyNews.com I 53

PRN and also has been shown to be highly immunogenic in elderly subjects.68 In addition, a vaccine derived from molecularly and chemically inactivated toxins A and B is currently undergoing Phase I clinical trials. Conclusion The incidence of CDI has increased dramatically over the past 2 decades and we have seen the emergence of epidemic strains with new resistance patterns, which have resulted in high morbidity and mortality. Despite the treatment advances in recent years, several challenges are still present: appropriate treatment of severe complicated/fulminant CDI; the management of CDI recurrence; proper management of repeat episodes and the BI/NAP1/027 strain; and, lastly, the role of vaccines, immunologics, and other biotherapeutics. The use of biotherapeutics to restore normal flora seems a novel and successful approach. There is a great need to continue to explore and develop new agents in the antimicrobial arena that spare the normal flora and perhaps most of all, avoid using antimicrobials altogether, whenever possible.

19. Keessen E, et al. Antimicrob Resist Infect Control. 2013;2:14.

28. Mullane KM, et al. Clin Infect Dis. 2011;53(5): 440-447.

36. Trzasko A, et al. Antimicrob Agents Chemother.r 2012; 56(8):4459-4462.

20. Eyre DW, et al. Clin Infect Dis. 2012;55(suppl 2): S77-S87.

29. Adachi JA, DuPont HL. Clin Infect Dis. 2006;42(4): 541-547.

37. Ting LS, et al. Antimicrob Agents Chemother.r 2012; 56(11):5946-5951.

21. Gutiérrez R, et al. BMC Infect Dis. 2013;13:609.

30. Curry SR, et al. Clin Infect Dis. 2009;48(4):425-429.

22. Cohen SH, et al. Infect Control Hosp Epidemiol. 2010; 31(5):431-455.

31. Rubin DT, et al. Gastroenterol Res Pract.t 2011;2011: 106978.

38. Mascio CT, et al. Antimicrob Agents Chemother.r 2014;58(7):3976-3982.

23. Teasley DG, et al. Lancet.t 1983;2(8358):1043-1046. 24. Zar FA, et al. Clin Infect Dis. 2007;45(3):302-307.

32. Garey KW, et al. J Antimicrob Chemother.r 2011; 66(12):2850-2855.

25. Wenisch C, et al. Clin Infect Dis. 1996;22(5):813-818.

33. Musher DM, et al. Clin Infect Dis. 2009;48(4):e41-e46.

26. Goldstein EJ, et al. Antimicrob Agents Chemother.r 2013;57(10):4872-4876.

34. Musher DM, et al. J Antimicrob Chemother.r 2007; 59(4):705-710.

27. Louie TJ, et al. N Engl J Med. d 2011;364(5):422-431.

35. Hecht DW, et al. Antimicrob Agents Chemother.r 2007;51(8):2716-2719.

39. Citron DM, et al. Antimicrob Agents Chemother.r 2012;56(3):1613-1615. 40. Chilton CH, et al. J Antimicrob Chemother.r 2014 May 9. [Epub ahead of print]. 41. Vickers R, et al. Presented at the 53rd Interscience Conference Antimicrobial Agents and Chemotherapy. Denver, CO: September 10-13, 2013. Abstract F-626. see C. diff page 68

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THE F IGHT

ask us

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non-narcotic pain relief means

References 1. CDC. 2011;60(34):1153-1185. 2. Centers for Disease Control and Prevention. http:// www.cdc.gov/HAI/organisms/cdiff/Cdiff_faqs_HCP. html. Accessed July 1, 2014. 3. Virginia Department of Health. http://www.vdh. virginia.gov/epidemiology/surveillance/hai/cdiff. htm#Citation2. 4. Arnold K, et al. Centers for Disease Control and Prevention. http://www.cdc.gov/HAI/pdfs/progressreport/hai-progress-report.pdf. 5. Magill SS, et al. N Engl J Med. 2014:370(13): 1198-1208. 6. Dubberke ER. Infect Control Hosp Epidemiol. 2014; 35(6):628-645. 7. Centers for Disease Control and Prevention. http:// www.cdc.gov/hai/eip/pdf/Cdiff-factsheet.pdf. 8. Centers for Disease Control and Prevention. http:// www.cdc.gov/vitalsigns/pdf/2012-03-vitalsigns.pdf. 9. Scott RD. http://www.cdc.gov/hai/pdfs/hai/scott_ costpaper.pdf. 10. Dubberke ER, Olsen MA. Clin Infect Dis. 2012;55 (suppl 2):S88-S92. 11. Leffler DA, Lamont JT. Am J Gastroenterol. 2012; 107(1):96-98.

VISIT BOOTH #1507 AT THE ANESTHESIOLOGY™ 2014 ANNUAL MEETING OCTOBER 11-13 | NEW ORLEANS, LA

In-Booth Presentations and Product & Technology Experience Saturday, October 11th SPEAKER

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Midwest Orthopedic Specialty Hospital Franklin, WI

Orthopedic Blocks

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Product & Tech Pod Booth #2101

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Do we need >24 hrs. of analgesia after major surgery?

5:30pm to 6:30pm

I-Flow Booth #1507

SUBJECT

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Mark Zimmerman, M.D.

The Christ Hospital, Cincinnati, OH

Sunday, October 12th SPEAKER

12. Khanna S, et al. Am J Gastroenterol. 2012;107(1): 89-95.

Stephen Spanos, M.D.

13. Kuijper EJ, Wilcox MH. Clin Infect Dis. 2008;47(1): 63-65.

Pediatric Anesthesiologists Inc Salt Lake City, UT

14. See I, et al. Clin Infect Dis. 2014;58(10):1394-1400. 15. Keel K, et al. J Clin Microbiol.l 2007;45(6):1963-1964. 16. Goorhuis A, et al. J Clin Microbiol. 2008;46(3):1157. 17. Rupnik M, et al. J Clin Microbiol. 2008;46(6):2146. 18. Brown KA, et al. Antimicrob Agents Chemother. 2013; 57(5):2326-2332.

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There are inherent risks in all medical devices. Please refer to the product labeling for Indications, Cautions, Warnings, and Contraindications. Failure to follow the product labeling could directly impact patient safety. Physician is responsible for prescribing and administering medications per instructions provided by the drug manufacturer. Refer to www.iﬂo.com for product safety Technical Bulletins. Rx only. *Registered trademark or trademark of Kimberly-Clark Worldwide, Inc. ©2014 KCWW All rights reserved. MK-00696 09/14 COMING SOON…

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PRN It’s Not Just the Bundle, It’s the Buy-In

Duke Protocol Reduces Colorectal SSIs by 75%

bundle of preventive measures can significantly reduce surgical site infections (SSIs) after colorectal surgery, but the strategy probably requires a “village” to be successful, a new study suggested. “You cannot do this alone,” said co-investigator Christopher R. Mantyh, MD, a colorectal surgeon and surgical oncologist in the Department of Surgery, Duke University Medical Center in Durham, N.C. “I had a lot of buy-in from people, and there was not much pushback at all.” In the study, a group of preventive measures was bundled and implemented pre-, during and postcolorectal surgery, which resulted in an almost 75% reduction in both superficial SSIs (5.7% after the intervention vs. 19.3% before; P<0.001) and postoperative sepsis (2.4% vs. 8.5%; P=0.009) ((JAMA Surg 2014 Aug. 27. [Epub ahead of print]). Bundles, which combine specific interventions, have become popular in infection control, according to Joseph Kuti, PharmD, associate director of clinical and economic studies at the Center for AntiInfective Research and Development at Hartford Hospital in Hartford, Conn., whose area of research is the use of bundles to improve outcomes in patients with infection. “By putting the bundle through as a package, the intent is that every single piece of the bundle will be followed,” said Dr. Kuti, who is also president of the Society of Infectious Diseases Pharmacists. “We think the sum is greater than the whole,” Dr. Mantyh explained. “If you did one [intervention], you might see a small improvement. If you add together five or 12 of these actions, there is an even greater improvement. I do not think any one action would move the needle significantly.” The colon and rectum are full of bacteria, so anytime a surgical procedure is performed in those areas, there is a high risk for infection; the risk for SSI from such surgical contamination ranges from 15% to 30%, according to the paper. The first step was recognizing this as a problem and not the norm. “It was an acceptable fact of life that when you operated on the colon or the rectum, you would see a surgical site infection in about onefourth of your patients,” Dr. Mantyh said. After Duke began participating in the American College of Surgeons National Surgical Quality Improvement Program, which provides prospective 30-dayy postsurgical outcomes data, the physicians became aware that their 20% rate of infection was a little higher than some other institutions. “When I initially tried to start this in 2010, I was kind of doing this on my own, and I met a lot of failure,” Dr. Mantyh admitted. “My realization was that I had to involve other folks, such as nursing and anesthesia, and once I did that, it became a lot easier.”

wound protectors with reports in the literature both supporting and not endorsing their use. “We felt that Pre-Op (5 measures) if we began to use them especially for our open cases, it could decrease the bacterial count in the subcutaEducate patients about SSI preventive measures and neous space,” Dr. Mantyh said. (For a positive study objectives. on the protectors, see Surg Infectt 2010;11:501-503.) Have patient shower with chlorhexidine. The input surrounding the antibiotic choice demPerform mechanical bowel prep with oral antibiotics. onstrates the type of interaction that was used Administer ertapenem within 1 h of incision. throughout the process. As a teaching hospital, resiStandardize preparation of surgical field with dents are frequently the ones providing postoperachlorhexidine alcohol. tive care at Duke. “We found that our residents were During surgery (6 measures) redosing antibiotics inappropriately,” he said. A discussion with the infectious disease physicians Use fascial wound protector. led to the idea of using ertapenem (Invanz, Merck) Change gown and gloves before fascial closure. because it is only dosed once before surgery. When Have a dedicated wound-closure tray. they talked with the pharmacist, however, there was Limit OR traffic. some concern about super selection of bacteria with Maintain euglycemia. this drug. Maintain normothermia during surgery. But a review found that this was not an issue at Post-Op (5 measures) Duke, so the idea was brought before the team and added to the bundle. Remove sterile dressing within 48 h. “The great thing about ertapenem is you give one Wash incision daily with chlorhexidine. dose preoperatively and that’s it. With that single act, Maintain euglycemia. we got in compliance with perioperative antibiotics,” Maintain normothermia in the early preoperative period. Dr. Mantyh said. Reinforce patient education about SSI preventive They began implementing the bundle on July measures and objectives. 1, 2011 and the adherence to the protocol was very high. In addition to the staff buy-in, the bundle had Sou ce JJAMA Su Source: Surgery ge g y 2014 0 Aug. ugg 27. [Epub [ pub p ahead a ead of o print]. p t] a champion in Dr. Mantyh, who met regularly with various departments to review recent SSI results and providers were involved in either putting together address any implementation problems. the bundle or its implementation. The team looked The use of the team approach to determine and at the entire colorectal surgery process from pre- implement the bundle and the champion were probop to post-op before deciding which measures to ably instrumental in the program’s success, according include in the bundle (Table). Some of the measures to Dr. Kuti. were evidence-based and others were commonsense “This is about culture change,” Dr. Kuti said. “You ideas that presented little patient risk, but had the need lots of education, and the support from key potential to reduce infections, said Dr. Mantyh in an opinion leaders, well-respected individuals and the administration. Then you need to collect data and interview. “We chose these [actions] for our bundle because analyze that data after implementation to demonthey were easy to do, low cost and everyone was on strate the intervention worked and can therefore board with them,” he said. (The largest cost was a be expanded—in this case, expanded to the other $10,000 outlay for 10 fascial closure tray packages.) colorectal surgeons.” There were a few areas that saw some heavy dis‘Phenomenal’ Results cussion among the team members. One was the use of mechanical bowel preparation and prophylactic To determine whether the bundle helped reduce antibiotics. “This is a controversial area,” Dr. Mantyh SSIs, the Duke researchers conducted a retrospective said. “There are some studies that show it does not study and looked at surgeries performed between Jan. improve SSI rates, maybe even makes them worse, 1, 2008 and Dec. 31, 2012. They reviewed the mediand some that show it does [improve rates]. But the cal records of 559 patients—346 underwent colorecmost recent data that have come out in the last few tal surgery before implementation of the bundle and years [Dis Colon Rectum 2012;55:1160-1166] indi- 213 underwent surgery after implementation—and cate that it is beneficial to decrease the SSI rates if found that the bundle was associated with a substanyou provide the bowel prep with antibiotics.” tial reduction in SSIs. After a discussion with the infectious disease staff, Indeed, the nearly 75% reduction in SSIs docuthe team also decided to limit OR traffic. “Anesthe- mented in the JAMA Surgery study was “a phenomesia and surgery had to get together and make sure we nal” result, said Ira L. Leeds, MD, MBA, who wrote an did not have extraneous people coming and going accompanying editorial in the journal. But he stressed The (Medical) Village through the OR because the ID [infectious disease] that “one needs to interpret them in the right context. A multidisciplinary team, including surgeons, anes- people said that was a great way to introduce air- Their SSI rate going into the [research] was something they made an intentional effort to reduce.” thesiologists, clinic nurses, operating room (OR) borne bacteria into your room,” he said. staff, unit nurses, house staff and hospital midlevel Another controversial area was the use of fascial see SSI page 57 Table. Perioperative Actions for Bundling

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ICD-10 Implementation Delay Gives Clinicians Time To Reduce Potential Headaches Chicago—The mandatory implementation deadline for the International Classification of Diseases, 10th Revision (ICD-10) coding system has been moved back from Oct. 1, 2014, to Oct. 1, 2015, easing pressure on clinicians who have not yet started

the change. But this may be the only opportunity to catch up. For clinicians who continue to delay, there is strong potential for chaos and perhaps lost income from a poorly planned transition. “It is fairly simple: If you are not

billing with ICD-10 codes for services provided on or after October 1, 2015, you will not be paid,” said David Harano, MBA, executive director of Gastro One, a large gastroenterology practice in Germantown, Tenn. Speaking at 2014 Digestive Disease Week

(DDW), Mr. Harano warned that implementation of ICD-10 codes “will cost you” in more staff hours for billing and perhaps less time with patients. All the potential problems are likely to be magnified with a head-in-the-sand approach, he added. “The problem is putting it on the back burner,” agreed Rhonda Buckholtz, CPC, CPMA, vice president for ICD-10 education and training at the American Academy of Professional Coders (AAPC), in Salt Lake City. According to Ms. Buckholtz, the codes are largely limited to process adjustments. Training is required, but productivity loss can be minimized with adequate planning and testing. “Studies suggest that practices can be up to speed in six weeks,” Ms. Buckholtz said. ICD-9 has been in use for approximately 30 years; it employs five-digit codes to record clinical tasks. With up to seven digits, ICD-10 codes have more room to capture meaningful use and quality metrics. The ICD-10 system has roughly five times the number of codes as its predecessor. For example, the handful of ICD-9 codes for the diagnosis and treatment of Crohn’s disease has been expanded to 25 codes, with capability to capture clinical information, Mr. Harano said. Single codes for diagnosis and treatment of conditions such as hemorrhoids have been expanded to capture such characteristics as grades of severity. When the ICD-10 codes were first released, news stories mocked examples of the most obscure descriptions, such as V91.07xD, which describes burns acquired from water skis on fire. The transition is more evolutionary than revolutionary because the codes, although more complex, largely perform the same function. It is a matter of adjusting to the new nomenclature. According to Ms. Buckholtz, “consultants are not essential” for a successful upgrade. One advantage of ICD-10 over ICD-9 is that is a better way to capture data on value-based health care. “If you are already focused on quality health care, the ICD-10 is going to be a more natural progression,” Ms. Buckholtz said, referring to the growing number of electronic medical record (EMR) systems that capture quality metrics. One example has been the widespread

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CONTINUED FROM PAGE 54

Results like this require changing behavior and that can be difficult, especially in medicine, added Dr. Leeds, the Halsted Surgical Resident at Johns Hopkins University School of Medicine, in Baltimore. “Even within a single health care institution, there are awfully high fences between departments, and these firm and sharp divisions really make it difficult to implement something system-wide. “This bundle was built from the ground up. There was a physician champion, but he got buyy in from the nursing staff, the techs. On top of that, they invited comment from all the people who are involved in the procedure,” he said, adding that the future of quality improvement in health care will require grassroots interventions like this. For Duke, Dr. Mantyh said, the bundle has become the standard of care for colorectal surgery, and surgeons in other areas with a high SSI rate, such as hepatobiliary surgery, are reviewing the results. “We are beginning to look at these other areas, but each is a little different,” he said, so the bundle would have to be tweaked by the staff in that department. Dr. Leeds said that is the way infection prevention should be done. These interventions are less about duplication and mandates and more about a process and buy-in, he explained. “When the people who are ultimately responsible for the performance measure are

efforts to amend EMR for colonoscopy in order to capture performance benchmarks independent of steps relevant to billing. This is consistent with the premise of the new ICD-10 codes. From the practical perspective, however, preparing for the change may be the biggest burden. The training alone for physicians and staff may be expensive, and it would be wise for every individual practice to conduct extensive testing before launching the full transition. Ironing out problems well before Oct. 1, 2015, is essential to prevent revenue flow disruptions, Mr. Harano said. “A line of credit may be important to avoid any cash flow issues if there are hiccups in the process,” said Mr. Harano, who added that he believes the new deadline will be enforced. —Ted Bosworth

the people designing the program, it becomes infused with a sense of ownership you cannot mandate.” He said people lampoon “committee think,” but a deliberative process can help improve quality. “Everyone in the operating room plays a very specific role, and they see things from very different perspectives. Unless you engage each of those individuals, you are going to end up with a solution that is not optimized for each individual’s role.” —Marie Rosenthal

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Eat Some Lettuce and See Me in the Morning: The Endless Search for Pain Relief A.J. Wright

the nostrils prior to surgery. Inhala- century. This collection of medical rection of the fumes allowed painless sur- ipes contains a very specific one for the Librarian, Anesthesiology Department, gery while the patient was unconscious. sponge. Ingredients included an ounce University of Alabama at Birmingham Herbs used included poppy, hemp, of opium, eight ounces of mandrake leaf juice, three ounces of henbane ne constant throughout henbane and mandragora. human history, unlimited by Recipes for this method from the juice, and green juice from hemlock. time or place, has been the Arab world date back to the 11th cen- Mixed with an appropriate amount search for pain relief. We have reached tury; others appeared in Italy, Germany of water, this concoction soaked into a point in the modern world where and Spain into the 16th century. The a sponge that was allowed to dry. anesthetics, narcotics, over-the-counter earliest known example is from the When needed, the sponge could be repain relievers, etc., can give some Bamburg Antidotarium of the ninth soaked in warm water for an hour, and measure of comfort in many painful situations. Yet, the search for improvement continues in neuroscience and pharmacology. The discovery, in the 1840s, that ether and chloroform vapors could offer significant pain relief during surgery enabled development of the idea in the West that pain did not always have to be endured. Yet, a vast literature created over the centuries and around the world documents earlier, less successful efforts at pain relief. Contemporary research in ancient and medieval manuscripts continues to uncover medical practices from cultures around the world, including recipes for treatments of many types of pain. Although published in 1946, Edgar S. Ellis’ book “Ancient Anodynes: Primitive Anaesthesia and Allied Conditions” is an excellent overview of the field. He covers pain relief by physical, psychological, inhalation and local methods. He cites many examples from the past: biological materials such as the poppy, belladonna, cannabis, hellebore, hemlock, garlic, curare and mandrake; various uses of alcohol; inhalation of different substances and mixtures; and snow or cold water. One interesting effort that Ellis notes is the “sleeping apple,” a ball made of a mix of substances and described by authors ranging from the Roman physician Dioscorides in the first century a.d. to Italian scholar Giambattista della Porta in the 17th century. As he catalogs this enormous number of pain relief methods, Ellis often expresses his skepticism about their efficacy. Perhaps many had placebo value. A method similar to the sleeping apple was the “soporific sponge,” or spongia somnifera. The sponge contained a mixture of herbals and was Two works by George Cruikshank, “The Headache” and “The Cholic,” ca. 1835. placed over the patient’s face or under Source: National Library of Medicine

was then ready to be placed under a patient’s nostrils for pain relief. Sleeping potions of various kinds found their way into medieval and Renaissance literature, as well. Boccaccio’s “The Decameron,” Shakespeare’s “Othello” and “Antony and Cleopatra,” Marlowe’s “The Jew of Malta” and “The Arabian Nights,” among others, feature such plot devices. How widely they were actually used in medicine remains unknown. For instance, the great 16th-century French surgeon Ambroise Paré did not use any such pain-relievingg methods. One would imagine that the spread of the recipe books throughout Europe during these centuries would have alerted physicians to the sponge and other pain relievers, if they had been truly effective. In 1847, the Lancet published an abstract of an article by a French physician named Dauriol, who claimed to have used a sponge recipe to achieve surgical anesthesia. In 1888, British physician Benjamin W. Richardson used a mandrake–alcohol mix for experiments on pigeons, rabbits and his own lips, noting a gentle sleep in the animals—unless too high a dose produced death. Scopolamine and other alkaloids in the plant no doubt helped produce the effects that he noted. Medical historian Plinio Prioreschi is a modern-dayy researcher who expressed skepticism about the sponge’s effectiveness in producing anesthesia for surgery, in a 2003 article in Medical Hypotheses. In their research in Old and Middle English scientific and medical manuscripts, Linda Voigts and Patricia Kurtz found some 40 anesthetic recipes. Thirteen of them apparently had limited circulation due to what must have been recognized as their dangerous ingredients. However, they found 27 examples of a brief recipe for “a drynke that men callen dwale to make a man to slepe whyle men kerven him.” In their book chapter, Voigts and Robert P. Hudson note that the word “dwale” could mean several things in Middle English: deception or delusion; a dazed or unconscious condition; a fool; the nightshade plant; or a soporific drink. The last meaning is used by Chaucer in “The Reeve’s Tale.”

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AnesthesiologyNews.com I 59

PRN ‘Pounded with vinegar, and employed as a gargle in the morning twice a month, the [stalk and leaves of “goat-lettuce”] act as a preventive of tooth-ache.’ —Pliny the Elder

dose. Hanaoka left records of dozens pain, and they could easily appreciate of surgeries, including many for breast our continuing efforts to find even betcancer. His illustrated “Surgical Case- ter methods than we have now. book” is available on the U.S. National Library of Medicine’s website (www. Additional Reading nlm.nih.gov). As with so many things, we tend to Bergman NA. Anesthetics of the ancients. In: Bergman look at past efforts at pain relief with NA. The Genesis of Surgical Anesthesia. Schaumburg, IL: Wood Library-Museum of Anesthesiology; 1998:1-28. amusement. Yet, many of these recipes contained active ingredients rec- Voigts LE, Hudson RP. A surgical anesthetic from late ognized much later. Visitors from medieval England. In: Campbell SD, et al. Health, the past would no doubt be amazed Disease, and Healing in Medieval Culture. New York, at what we moderns can do to relieve NY: St. Martin’s Press; 1992:34-56.

Contact the editor of Anesthesiology News

jprudden@ mcmahonmed.com

“The Natural History” [Book 20, Chapter 24; 1855 Bostock translation]

The drink recipes are fairly consistent across the examples that the researchers found. Ingredients included swine gall, hemlock juice, wild nept, lettuce, poppy, henbane and vinegar. After boiling, the mixture could be stored until needed, after which three spoonfuls were to be mixed with a gallon of wine. The authors’ discussion of these ingredients, and the relationship of this recipe to others, is fascinating. An example of a surgical anesthetic used in Japan well before 1846 has become well known in the West in recent decades. Seishu Hanaoka was a surgeon born, appropriately enough, in October 1760; he died in 1835. Hanaoka improved herbal recipes for pain relief that came from China to the point where he was able to use the oral anesthetic in major surgeries. His formula is known as Tsusensan: two main ingredients were mandarage of the Datura genus and Aconitum japonicum. The patient drank the hot liquid, and in two to four hours was ready for surgery. The effects lasted six hours or longer depending on the

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Pre-Op Atrial Fibrillation Likely To Recur Post-Op Montreal—A new screening tool, the aFlame score, may help identify cardiac surgery patients at risk for developing postoperative atrial fibrillation. But this tool is not necessary for patients with the condition before surgery, as the overwhelming majority of them will still develop it after the conclusion of surgery, according to a study from the University of Ottawa Heart Institute.

“Atrial fibrillation has been found to affect 20% to 45% of patients after cardiac surgery,” said Emily Conrad, MS, a medical student at the University of Ottawa, in Ontario, Canada. “We care about it because if you’re able to predict patients at risk for developing postoperative atrial fibrillation, then we can use targeted intervention that’s been shown to be effective.”

Diem Tran, MD, assistant professor in the Department of Anesthesiology at the University of Ottawa, who created the atrial fibrillation score, said its purpose was to help limit amiodarone use to the patients who need it most. “We can’t give everyone amiodarone, in Canada; we don’t have the budget for that. Plus, there’s a risk with anything that you give, so we wanted something to help us

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stratify who gets the drug,” she said. The aFlame score is composed of three variables: age 65 years or older, any mitral valve disease and left atrial dilatation. The researchers aimed to test the predictive value of the scale in patients who already have atrial fibrillation. The study included 362 patients (mean age 69 years; 67% males) with a history of atrial fibrillation, who underwent non-emergent coronary artery bypass graft surgery and/or valve surgery at the institution, in 2010 through 2011. Using prospectively collected data from a perioperative database supplemented with detailed chart review, the patients were assessed for development of postoperative atrial fibrillation and clinical outcomes in the hospital. Ms. Conrad reported the findings at the 2014 annual meeting of the International Anesthesia Research Society (abstract S-85). The researchers found that 293 of the 362 patients (81%) developed postoperative atrial fibrillation. Based on the aFlame score, 44%±14% of patients were predicted to have the condition. All observed rates of postoperative atrial fibrillation were significantly higher than predicted at each level of the score (P<0.0034). “When we looked at postoperative outcomes, we found that patients who had preoperative atrial fibrillation stayed, on average, in the hospital about a week longer than their counterparts [18.1 vs. 11.5 days; P=0.001],” Ms. Conradd said. “They also had significantly more complications, including pulmonary edema and acute-onset renal failure, which are known to be associated with atrial fibrillation. “So, our final conclusion was that, as anticipated, patients with preoperative atrial fibrillation do not need a clinical score, and the aFlame score we developed is not necessary in this test group. The majority of patients who have preoperative atrial fibrillation will go on to develop it postoperatively.” The researchers recommended clinical prophylaxis when appropriate. Prophylaxis can take several forms, although many attendees suggested amiodarone as the best option. “There are all kinds of different amiodarone prophylactic regimens that have been published and studied,” said session moderator Michael H. Wall, MD, professor of anesthesiology at the University of Minnesota Twin Cities Medical School, in Minneapolis. “And it doesn’t really matter which one you use; they all seem to work.” —Michael Vlessides

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SCIP Data Find Improvements in Heart Surgery Safety Measures Montreal—Adherence rates on six core Surgical Care Improvement Project (SCIP) measures improved annually between 2008 and 2012 by hospitals performing heart valve surgery. The research was performed at the University of Chicago. “SCIP is a national initiative to help improve surgical care by reducing surgical complications,” said Lisa Sun, MD, an investigator who is now a resident at the University of California, San Francisco. “There is a set of SCIP measures that hospitals try to comply with. How hospitals perform on these metrics is related to Medicare and Medicaid reimbursement and is also publicly recorded.” Using data from Medicare’s Hospital Compare website (data.medicare.gov/data/hospital-compare), the researchers examined performance on the following six core measures, whose domains involved infection (INF) and venous thromboembolism (VTE): • INF-1: received prophylactic antibiotics within one hour of surgical incision; • INF-2: received appropriate prophylactic antibiotics; • INF-3: prophylactic antibiotics were discontinued within 24 hours of surgery end time; • INF-4: cardiac surgery patients with controlled 6 a.m. blood glucose levels; • VTE-1: treatment ordered to prevent VTE; and • VTE-2: treatment recorded to prevent VTE within 24 hours before or after surgery. These six measures were selected because they were reported every year during the study period. As Dr. Sun explained at the 2014 annual meeting of the International Anesthesia Research Society (abstract S-221), only hospitals performing heart valve surgery were included. The average performances for individual measures and the aggregate of all six measures were calculated for each year. It was found that over the past five years, the average nationwide performances for each of the individual SCIP measures and the aggregate of all six measures improved annually between 2008 and 2012. Indeed, the aggregate adherence rate increased from 91.02% in 2008 to 97.97% in 2012. Interestingly, it was also found that the number of hospitals performing valve surgeries that also recorded SCIP performance fell from 768 in 2008 to

568 in 2012. “A theory we have is there might be a kind of survivor bias here in which the low performers are dropping off each year or are being culled from the herd,” Dr. Sun reported. “This information is helpful because SCIP measure performance is used for both public reporting of hospital performance as well as for Medicare and Medicaid reimbursement,” she added.

“So for an individual hospital, it’s not enough to have a high adherence rate to SCIP measures, it’s important to continually improve compliance rates because other hospitals around the country are also improving their performance.” Session moderator George M. Hall, MB, BS, PhD, professor of anesthesia at St. George’s University of

London, United Kingdom, wondered how increased adherence might affect patient outcomes. “How do these findings correlate to decreased morbidity and decreased length of stay?” he asked. “Because if it doesn’t, is it just sort of a selff fulfillingg exercise for bureaucrats?” —Michael Vlessides

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CONTINUED FROM PAGE 1

Midazolam (mg/kg)

1.6

Propofol (mg/kg)

0.04

Fentanyl (mcg/kg)

Medicine, New Haven, Conn. “In addition, there’s some older literature showing that elderly patients with lower intraoperative BIS [bispectral index] levels have worse outcomes than their counterparts. This suggests that deeper anesthesia may have some longer-term morbidity and mortality. “So we decided to investigate the current practice in the field,” Dr. Akhtar said. “Are practitioners generally following recommendations by reducing IV induction doses for the elderly?” To that end, Dr. Akhtar and his colleagues reviewed the intraoperative electronic anesthetic records of 1,868 adults (≥18 years) receiving general anesthesia for gastrointestinal surgeries between February 2013 and January 2014. Patients undergoing

multiple procedures, those requiring temporary abdominal closure, and/ or those undergoing rapid sequence induction were excluded from the analysis. Post-induction mean arterial pressure (MAP) was measured within the first 10 minutes of induction. There was a significant decrease in the dosing of fentanyl, propofol and midazolam with increasing age (Table). Despite this age-based dosing reduction, the researchers still found a significantly larger drop in MAP following induction in patients older than 70 years. Indeed, those younger than 70 had a mean MAP decrease of 17 mm Hg, whereas those older than 70 had a 23 mm Hg MAP decrease. The investigators also found a significant decrease in fentanyl and propofol dosing with increasing American Society of Anesthesiologists (ASA)

Table. Anesthesia Dosing by Age 18-70 y

>70 y

P Value

Midazolam, mg/kg

0.018

0.006

<0.01

Fentanyl, mcg/kg

1.30

1.18

<0.01

ASA I/II

1.36

1.17

0.06

ASA III/IV

1.27

1.17

0.15

2.20

1.70

<0.01

ASA I/II

2.34

1.88

<0.01

ASA III/IV

1.96

1.65

<0.01

Propofol, mg/kg

ASA, American Societyy of Anesthesiologists g

classification (P<0.01). There was no significant difference in midazolam dosing based on ASA classification, however (P=0.47). Additionally,

0.03 0.02 0.01 0

1.4 1.2 1

3 2 1 0

MAP Change (mm Hg)

0 -5 -10 -15 -20 -25 30

Age Group 18-30 (n=290)

31-40 (n=253)

41-50 (n=362)

51-60 (n=399)

61-70 (n=324)

71-80 (n=179)

>80 (n=61)

Figure. Average weight-based doses of different induction anesthetics and post-induction changes in mean arterial pressure are shown for different age groups. Standard error bars are included.

patients classified as ASA III and IV (n=792) did not exhibit a significant fentanyl dose change with increasing age. Although he was encouraged by the age-based decrease in dosing revealed by the study, Dr. Akhtar was still concerned that older patients are receiving more induction agent than necessary (Figure). “For example, one article gave a propofol range of 1 to 2 mg/kg in elderly patients,” he said. “In our study, patients received doses at the upper end of that range. The same article gave a fentanyl range between 0.5 and 1 mcg/kg in elderly patients, and in our study patients received greater than 1 mcg/kg. “So we are potentially overdosing these patients, and we could be using much less. So the question is what kind of impact might that have? If the blood pressure drops, then you might need to give other medications in response,” he continued. “But you’re not always able to do that quite as easily in elderly patients as in younger patients.” Dr. Akhtar, who is presenting his findings at the ASA’s 2014 annual meeting (abstract A1243), recognized that some clinicians might be hesitant to administer lower doses than they are otherwise comfortable with. “I think people might be afraid they’re not anesthetizing the patient completely and afraid of possible recall at the lower dose, especially if they’re not using a depth-off anesthesia monitor. I think that’s what makes people give more drug rather than less. Remember we can always start with less and give more if necessary. “My recommendation is that we should aim more for the lower end of the recommended dose rather than the higher end,” he concluded. —Michael Vlessides

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Electrical Median Nerve Stimulation Eases Nausea, Vomiting During Cesarean Delivery Montreal—Electrical median nerve stimulation effectively reduced nausea and vomiting in women undergoing cesarean delivery with combined spinal–epidural (CSE). Investigators also found that patient satisfaction was significantly greater in the nerve stimulation group than in controls. Electrical median nerve stimulation already has been shown to reduce nausea and vomiting in general anesthesia. “This study compared two groups of patients: one group with electrical median nerve stimulation and the other group without,” said Jacques Lorthe, MD, a resident at the Robert Wood Johnson Medical School, in New Brunswick, N.J. The researchers enrolled 153 parturient women into the retrospective trial; each was undergoing cesarean delivery with CSE. Seventy-six patients received no therapy; the remaining 77 received median nerve stimulation

from the onset of the procedure until Table. Nausea/Vomiting Satisfaction: Control Group vs. Nerve Stimulation arrival in the postanesthesia care unit Controls Nerve Stimulation (PACU). A host of perioperative data n=76 (%) n=77 (%) P Value was recorded, including nausea and 30/63* (47.6) 20/68* (29.4) 0.032 vomiting during and after the pro- Vomiting during procedure cedure, satisfaction with treatment Nausea during procedure 50/72 (69.4) 32/71 (45.1) 0.003 for nausea and vomiting, and overall Phase 1: Nausea after application 39/75 (52.0) 21/76 (27.6) 0.002 patient satisfaction. of CSE “We used a twitch monitor on conPhase 2: Nausea after eversion of 11/71 (15.5) 13/75 (17.3) 0.764 tinuous setting that was placed at the uterus distal crease, medial to the flexor carpi radialis tendon,” Dr. Lorthe explained. Phase 3: Nausea after replace13/71 (18.3) 12/74 (16.2) 0.739 “We started it as soon as the patient ment of uterus was comfortable.” Phase 4: Nausea upon arrival to 4/71 (5.6) 1/71 (1.4) 0.366 As reported at the 2014 annual PACU meeting of the International AnestheNausea/vomiting satisfaction, 27/74 (36.5) 47/76 (61.8) 0.0019 sia Research Society (abstract S-190), 8-10 on 10-point scale, with 10 the groups were similar with respect being fully satisfied to demographics and perioperative benchmarks, including hypotension. CSE, combined spinal–epidural; PACU, postanesthesia care unit Signifying number reporting/total patients with data for this item. Not all patients in this retrospective review had all itemized The groups generated comparable find- *information o at o oon file. e ings with respect to nausea after eversion of uterus, nausea after replacement of the uterus, nausea upon arrival to

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the PACU and overall patient satisfaction. As the Table illustrates, however, there were significant differences between groups with respect to nausea and vomiting during the procedure and satisfaction with control of nausea/ vomiting. “The bottom line is that we noticed a decreased incidence of nausea and vomiting in patients who received the electrical nerve stimulation, both during and after the procedure,” Dr. Lorthe said. “However, it did not show much difference in terms of preventing nausea and vomiting during the most stimulating part of the cesarean delivery.” “So does this technique show any promise?” asked session moderator Cynthia A. Wong, MD. “Where are you going with this?”

“A few of us in our institution believe in electrical median stimulation,” Dr. Lorthe replied. “So we continue to use it, and it shows promise. Whether or not we’re going take it to another setting, I don’t know.” “This study provides preliminary evidence that the technique works prophylactically,” said Dr. Wong, professor in anesthesiology at Northwestern University’s Feinberg School of Medicine in Chicago. “Further study using a randomized controlled trial design is indicated. Additionally, it would be interesting to see if there’s any indication in which you could use it therapeutically.” The poster was honored at the meeting as a “best of category” in obstetric anesthesia. —Michael Vlessides

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Hydroxyethyl Starch Linked to AKI in Liver Transplant Patients at our institution is largely protocoldriven,” he explained. “We use arterial waveform analysis to determine fluid responsiveness to hypotension. We all keep central venous pressure at around 10. We try to keep hematocrit levels between 24 and 30. So we are all pretty uniform how we treat these patients.” James Findlay, MBChB, director of liver transplant anesthesia at

Mayo Clinic, in Rochester, Minn., was not surprised by these findings given recently published trials and metaanalyses that demonstrate an association between the use of HES for resuscitation in ICU patients and renal injury. “The ICU studies also suggest an increased mortality with the use of hydroxyethyl starch; although this was not a finding in Dr. Whiteley’s

study, I would be concerned that the renal injury reported could translate into worse outcomes in larger series of patients,” he said. “With the available evidence, I don’t think the continued use of hydroxyethyl starch is justified in liver transplantation. If colloids are required, I’d favor using 5% albumin.” —Michael Vlessides

RELENTLESS

Montreal—Patients undergoing orthotopic liver transplant who receive 6% hydroxyethyl starch (HES) have an increased risk for acute kidney injury (AKI) compared with those who receive 5% albumin. Researchers recommended that the starch derivative not be used in this patient population. “Back in 2010, our Pharmacy and Therapeutics Committee recommended that we transition from albumin to hydroxyethyl starch for all surgical procedures,” said Joseph Whiteley, DO, assistant professor of anesthesiology at the Medical University of South Carolina in Charleston. “However, a recent study [N Engl J Medd 2012;367:1901-1911] found an association between the colloid and acute kidney injury. Given that kidney injury following liver transplantation is a very common complication, this retrospective study was our attempt to gauge whether hydroxyethyl starch does, indeed, lead to increased postoperative acute kidney injury in this patient population.” Dr. Whiteleyy and his colleagues performed a retrospective, cross-sectional analysis of the institution’s electronic anesthesia records, surgical dictations and perioperative laboratory records. Postoperative AKI was determined by the RIFLE criteria (i.e., risk, injury, failure, loss and end-stage renal disease). AKI was classified one of three ways—risk, injury or failure—based on change in serum creatinine from preoperative baseline to peak level by postoperative day 7. As Dr. Whiteley reported at the 2014 annual meeting of the International Anesthesia Research Society (abstract S-132), the records of 174 orthotopic liver transplant patients were reviewed. Of these, 50 received only 5% albumin, 25 received both albumin and HES, and 99 received only HES. There was a statistically significant association between the type of colloid administered and AKI. Indeed, patients who received HES were three times more likely to develop AKI within seven days of surgery than their counterparts who received albumin (adjusted odds ratio, 2.94; 95% confidence interval, 1.13-7.7; P=0.027). The linear association between any colloid use and the development of AKI was statistically significant (P=0.048). No difference was found in 30-day mortality between the three groups. “The way we administer colloids

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New York State Pain Center Views Chronic Pain Through a Distinctive Lens

wo lumbar laminectomies left retired college professor Lewis Neisner with nerve damage and severe pain in his left leg. After seeing a number of physicians who were unable to help him, Mr. Neisner took the advice of friends and made an appointment at the Neuromedicine Pain Management Center (NPMC) at the University of Rochester Medical Center, in Rochester, N.Y. “I was hoping the center could relieve my pain or at least make it more manageable,” he said. At NPMC, Mr. Neisner was surprised that he did not have to undergo the same battery of tests administered by other physicians—including yet another magnetic resonance imaging (MRI) scan—but instead got a complete neurologic exam. Investigating the neurosensory aspects and functional consequences of chronic pain defines NPMC’s pain management approach. “We have a distinctive lens,” said John Markman, MD, NPMC’s director. “The preface to an Institute of Medicine report in 2011 stated, ‘chronic pain arises from the nervous system.’ We focus on pain as it relates to nerve injury in the setting of a neurobehavioral syndrome.” NPMC has been delivering coordinated pain management since 2008, tailoring treatment plans that stress diverse approaches and continuity of care. It is uniquely situated within the University of Rochester Medical Center’s Department of Neurosurgery, where it collaborates with surgical colleagues in managing the long-term, often painful consequences of craniotomy, laminectomy, brachial plexus avulsion and tumor resections. It also performs novel functional risk assessment up-front and postintervention for elective surgeries, such as lumbar stenosis decompression. In 2013, the American Pain Society honored NPMC with its Clinical Center of Excellence Award for outcomes, multidisciplinary care and research. It was the only academic medical center to earn the award in 2013.

whether painful peripheral neuropathy or postherpetic neuralgia, results in a chronic problem that cannot be resolved with a single pill, injection or surgery. “In most patients, different levels of the nervous system are involved, so our challenge is to figure out what parts are contributing to a patient’s pain experience at a given moment,” Dr. Markman said. “We focus on understanding that experience—that is, all of the qualityoff life aspects regarding a patient’s pain. We want to help patients understand this experience and not have pain as the axis around which their lives revolve.” To treat the “experience of pain” effectively, NPMC harnesses the strengths of multiple, innovative therapies—medical management, as well as rehabilitative, psychological, integrative and complex procedural interventions. This approach emphasizes improved coping and selff efficacy. y Clinician–patient conversations, medications, diagnostic queries and interventions seek to minimize fearavoidant behaviors and de-emphasize pain intensity in favor of functional improvement. To this end, NPMC has created programs of excellence for specific pain conditions, such as its trigeminal neuralgia (TN) program, which incorporates quantitative sensory testing and evaluation of conditioned pain modulation into treatment decisions. TN can cause intense stabbing or electrical shock–like facial pain, originating from the trigeminal nerve. When patients with TN come to NPMC, a neurologist examines them; a neuroradiologist interprets imaging findings; a dentist excludes oral pathology; and a neurosurgeon explores the gamut and timing of procedural treatment options. “Our team of medical and surgical experts work together to fully assess a TN patient’s pain and provide all options—medical, surgical or a combination—in a comprehensive treatment paradigm,” Dr. Markman said. NPMC’s TN program is the only one of its kind in upstate New York.

No Single Remedy State-of-the-Art Center NPMC operates under the belief that chronic pain is both a symptom NPMC is a 10,000-square-foot faciland an underlying neurologic disor- ity linked to the University of Rochesder. Its care is grounded in the notion ter Medical Center, where world-class that the most complex nerve injury, diagnostic technologies—such as

John Markman, MD, director of the Neuromedicine Pain Management Center, and Babak S. Jahromi, MD, PhD, surgical director of the Stroke and Cerebrovascular Center, confer on the best approach and landmarks for a trigeminal rhizotomy.

computer-assisted imaging guidance, functional MRI and awake brain mapping—are standard. It is conveniently located near the medical center’s main facility, Strong Memorial Hospital, and other resources such as the university’s Investigational Drug Service Pharmacy. The center’s team is multidisciplinary, with neurologists, neurosurgeons, pain medicine specialists, radiologists, anesthesiologists, psychologists, physical therapists, and nurse practitioners and technicians of all types working in concert to help pain patients overcome their pain and get their lives back. “Our team collaborates on all levels to provide quality care,” said Shirley Rast, NP, one of NPMC’s advanced practice providers. “We review imaging, treatment and responses to surgery and medications to plan together the next step in a patient’s care. We confer with referring providers, psychologists, psychiatrists, counselors and physical therapists to optimize care.” The advanced practice providers’ function at NPMC adds a depth to the collaborative nature of its team not often seen at other pain centers. “We are nationally certified and state licensed,” Ms. Rast explained. “Our role involves evaluating and diagnosing new patients, including imaging and diagnostic testing; setting up treatment plans and interventions;

and medical management, such as recommending and/or prescribing controlled and noncontrolled medications. We follow up with patients to evaluate their responses to treatment—interventional, surgical, pharmacologic and nonpharmacologic. Our practice incorporates individual counseling as an integral component of pain management. In the end, we try to get patients to understand their pain, motivations and drivers to customize their care.” “We also are committed to treating patients over the lifetime of the problem,” Dr. Markman added. “We just don’t treat symptoms. This is especially important with chronic conditions, which often are long term.” More than 8,000 patients from western New York state, the Finger Lakes region, as well as Pennsylvania and Canada, seek NPMC’s help each year. Recently, the center has made efforts to reach more patients in underserved rural areas by opening an outreach clinic in Auburn, N.Y., some 70 miles away, and it hopes to establish additional satellite locations over the next year. Discovering Tomorrow’s Treatments NPMC is actively involved in research and clinical trials in an effort to discover new chronic pain treatments. Research is conducted at its see NYS pain page 68

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Translational Pain Research Unit, a separate 3,000-square-foot research facility that includes five patient examination rooms; a procedure suite, with fluoroscopic guidance for cerebrospinal fluid sampling and conscious sedation capabilities; four recovery rooms; and a dedicated trial monitor room, with high-speed broadband for remote data entry. The principal focus of the research program has long been low back pain, the most common chronic pain syndrome. Recent clinical studies include a placebo-controlled, randomized, double-blind crossover clinical trial on postlaminectomy pain and randomized controlled trials on the most common treatments for lumbar stenosis. The center also initiates and participates in clinical trials on urine drug testing methods, protein therapies and devices such as spinal cord stimulators. Dr. Markman and Babak S. Jahromi, MD, PhD, surgical director of the Stroke and Cerebrovascular Center, are leading a team that is investigating new treatments for neuropathic craniofacial pain involving the nucleus caudalis. Since its founding, NPMC has made outcome assessment a critical component of care. It has conducted the Neurosurgical Outcomes Project to collect and store health care information on the large number of patients it has treated for lumbar spinal stenosis and other index conditions. More recently, the center has used the Patient Global Impression of Change index, which rates the response of a condition to therapy with pain scores and other required electronic medical record components, capturing this feedback with every patient encounter. Educating pain specialists, medical students and the public about chronic pain is another key role that NPMC

plays in advocacy efforts for patients with chronic pain. Its continuing medical education (CME) program, Advances in Pain Management, and monthly Translational Pain Research Forum CME series, launched in 2009, bring together basic and clinical scientists with pain practitioners of all types throughout the region.

“We also offer educational activities geared toward clinicians of varied backgrounds including physicians, physician assistants, nurse practitioners, pharmacists, therapists and nurses, as well as all other allied health care professionals, who on a daily basis confront the challenge of treating acute and chronic pain conditions,” said Dr. Markman.

C. DIFF

48. Chilton CH, et al. J Antimicrob Chemother.r 2012; 67(10):2434-2437.

56. Konijeti GG, et al. Clin Infect Dis. 2014;58(11):1507-1514.

62. Louie T, et al. Presented at IDWeek; San Francisco, CA: October 2-6, 2013. Abstract 89.

49. Chilton CH, et al. J Antimicrob Chemother.r 2013; 68(9):2078-2082.

57. ACG, AGA, ASGE, IDSA, NASPGHAN. Current consensus guidance on donor screening and stool testing for FMT. http://www.gastro.org/research/Joint_Society_FMT_Guidance.pdf.

63. Merrigan MM, et al. Int J Antimicrob Agents. 2009; 33(suppl 1):S46-S50.

CONTINUED FROM PAGE 53

42. Vickers R, et al. Presented at the 51st Interscience Conference Antimicrobial Agents and Chemotherapy. Chicago, IL: September 17-20, 2011. Abstract B-1194. 43. Chilton CH, et al. J Antimicrob Chemother.r 2014; 69(3):697-705.

The Neuromedicine Pain Management Center’s multidisciplinary team provides coordinated pain management services and tailors treatment plans for each patient.

John Markman, MD, director of the Neuromedicine Pain Management Center, visits a patient to discuss her treatment plan.

50. Howerton A, et al. J Infect Dis. 2013;207(10): 1498-1504. 51. Lowy I, et al. N Engl J Med. d 2010;362(3):197-205.

As for Mr. Neisner, selecting NPMC proved the right decision. His treatment plan included a switch from oral hydrocodone to a buprenorphine transdermal patch for more convenient and durable pain relief. He also participated in a clinical trial investigating a new medication for neuropathic pain in people who have had lumbar surgery. “It has been a very positive experience,” he said. “The center has helped me manage my pain more effectively. It has educated me about my pain, and that has given me peace of mind. And I have confidence that if I need something more, it can provide it.” —Tom McDonough

58. Hamilton MJ, et al. Gut Microbes. 2013;4(2):125-135.

64. Villano SA, et al. Antimicrob Agents Chemother.r 2012;56(10):5224-5229.

59. Youngster I, et al. Clin Infect Dis. 2014;58(11):1515-1522.

65. Goldenberg JZ, et al. Cochrane Database Syst Rev. v 2013;5:CD006095.

44. Baldoni D, et al. J Antimicrob Chemother.r 2014;69(3): 706-714.

52. van Nood E, et al. N Engl J Med. d 2013;368(5):407-415.

45. Locher HH, et al. Antimicrob Agents Chemother.r 2014;58(2):892-900.

53. Brandt LJ, et al. Am J Gastroenterol.l 2012;107(7): 1079-1087.

46. O’Connor R, et al. J Antimicrob Chemother.r 2008; 62(4):762-765.

54. Kassam Z, et al. Am J Gastroenterol.l 2013;108(4): 500-508.

60. North York General Hospital. Spotlight on research: Sumit Raybardhan, infectious diseases pharmacy practitioner. http://www.nygh.on.ca/Default. aspx?cid=2492&lang=1. Accessed July 1, 2014.

47. Baines SD, et al. J Antimicrob Chemother.r 2008; 62(5):1078-1085.

55. Kelly CR, et al. Am J Gastroenterol.l 2014 Jun 3. [Epub ahead of print].

61. Petrof EO, Khoruts A. Gastroenterology. y 2014;146(6): 1573-1582.

66. Torres JF, et al. Infect Immun. 1995;63(12):4619-4627. 67. Leuzzi R, et al. Hum Vaccin Immunother. 2014;10(6). 68. Valneva website. http://www.valneva.com/?page=85. Accessed June 28, 2014.

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Combined Propofol and Fentanyl Improves Anesthesia Quality in EGD Montreal—When used together, propofol and fentanyl are more effective than propofol alone in patients having upper gastrointestinal endoscopies, according to a pilot study. Medhat Hannallah, MD, and his colleagues at Georgetown University Hospital, Department of Anesthesia, in Washington, D.C., conducted a doubleblind, placebo-controlled study that compared propofol with combined propofol and fentanyl in 100 patients undergoing esophagogastroduodenoscopy

(EGD). They presented their findings at the 2014 annual meeting of the International Anesthesia Research Society (poster S-28). Physicians favor using propofol because it takes effect quickly and has the advantage of being short-acting, which equates to faster recovery times. The drug, however, lacks analgesic properties; consequently, larger doses are needed to adequately anesthetize patients before beginning a procedure. Gagging is common.

Some anesthesiologists use fentanyl, a powerful opiate, along with a lesser amount of propofol to curb the risk for airway irritability. However, using the two drugs in combination can increase the risk for respiratory depression and hypotension. Dr. Hannallah and his colleagues found in their study that propofol and fentanyl, when carefully managed, could be used effectively for EGD patients. “If you give the propofol and the fentanyl in this slow, controlled way, you

are likely to get better sedation conditions without increased risk of respiratory depression,” Dr. Hannallah said. For this study, anesthesiologists used a 10-point scale to rate the quality of anesthesia in patients receiving one or the other treatment during EGD. Patients were evenly divided and randomly assigned to one of two groups: a propofol group and a combined propofol and fentanyl group. The 50 patients in the combination group received initial doses of fentanyl 1 mcg/kg followed by propofol 0.75 mg/kg bolus. Those in the propofolonly group received initial doses of propofol 1.5 mg/kg bolus. Most patients needed additional propofol see EGD page 72

Chicago—Although nonsteroidal antiinflammatoryy drugs (NSAIDs) have long proved helpful in the battle against acute pain relief for surgical patients, their side-effect profile has prompted the FDA to urge clinicians to use the lowest dose possible. That goal has moved one step closer to reality with the results of a Phase III trial of low-dose diclofenac capsules, which proved efficacious in bunionectomy patients. “Diclofenac is a nonsteroidal that’s been available for many years, but now we have a delivery system that allows for lower dosing,” said Tong-Joo Gan, MD, professor of anesthesiology and vice chair of clinical research and faculty development at Duke University Medical Center in Durham, N.C. “There is typically quite a bit of pain following bunionectomy, and it also causes significant tissue inflammation, and what better than an NSAID to manage the pain?” Dr. Gan asked. “It would be nice to have a drug formulation that allows for lower dosing, which could potentially reduce the risk for developing some dose-related side effects, including gastrointestinal—i.e., ulcers and bleeding—cardiovascular, and renal adverse effects, yet still provide good efficacy.” The study included 428 patients who were randomized to one of four treatment groups: 35-mg diclofenac capsules three times daily (n=107); 18-mgg diclofenac capsules three times daily (n=109); 400-mgg celecoxib tablet as a loading dose followed by 200 mg twice daily (n=106); or placebo (n=106). Hydrocodone/acetaminophen (10 mg/325 mg) was used as rescue medication. Patients selff assessed their pain on a 100-mm visual analog scale at a variety of time points throughout the study period; clinically meaningful pain relief was defined as a reduction in pain intensity of at least 30%. As reported at the 39th annual meeting of the American Society of Regional Anesthesia and Pain Medicine, 86.7% of patients in the study were women. Significantly more patients receiving the

Proportion of Patients Achieving a ≥30% Reduction in Pain Intensity (%)

Low-Dose Diclofenac Effective in Bunionectomy Patients 120 100 80

■ SoluMatrix Diclofenac 35 mg TID (n=107) ■ SoluMatrix Diclofenac 18 mg TID (n=109) ■ Celecoxib 400 mg loading dose, 200 mg BID (n=106) ■ Placebo (n=106)

72.9 P<0.0001

68.8 P<0.0001

91.6 P<0.0001

91.7 P<0.0001

100 P=0.0006 84.9 P=0.0086

97.2 P=0.0235

92.5 P=0.4707

89.6

69.8

62.3 P=0.0025

60 41.5

40 20 0 12 h

24 h

48 h

Treatment Groups Over Time

Figure. Pain relief in three treatment groups and placebo over 48 hours. 35-mgg diclofenac dose achieved clinically meaningful pain relief than those taking placebo at 12 (P<0.0001), 24 (P<0.0001) and 48 hours (P=0.0006) after the initial dose (Figure). By comparison, significantly more patients taking celecoxib had clinically meaningful pain reduction versus placebo at 12 and 24 hours (P=0.0025 and 0.0086, respectively), but not at 48 hours (P=0.4707). Not surprisingly, the three treatment groups also achieved clinically meaningful pain relief more rapidly than those receiving placebo (Figure). “Although the study wasn’t powered specifically to compare side-effect profiles, the low-dose diclofenac was generally well tolerated,” Dr. Gan told Anesthesiology News. The most frequent adverse events in the diclofenac groups were postprocedural edema (32.9%), nausea (27.3%), headache (13.0%) and dizziness (10.2%). One episode of deep vein thrombosis was reported in a patient in the celecoxib arm, although it was determined to be unrelated to the drug. “Diclofenac has been around for a long time, and is a very interesting nonsteroidal in that it also seems to

have some other mechanisms of action,” Dr. Gan said. “This study demonstrates that the drug is effective against pain after bunionectomy, and has the potential to reduce some of the nonsteroidal-related side effects. But I think future studies should focus more closely on the side-effect profile.” Girish P. Joshi, MD, professor and director of perioperative medicine and ambulatory anesthesiology at the University of Texas Southwestern Medical School in Dallas, lauded the researchers’ efforts, but questioned the portrayal of the diclofenac administration as “low dose.” “The total daily dose of diclofenac in this study is similar to what is currently used,” he said. “In addition, concerns regarding cardiac and gastrointestinal adverse effects are more realistic for chronic use, not short-term acute use,” Dr. Joshi said. “The technology that allows rapid absorption of drugs appears to be sound, but how it will fit in the perioperative setting remains to be seen. My guess is its greatest benefit will be in chronic/long-term use.” —Michael Vlessides

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boluses before they reached an adequate depth of anesthesia. Although physicians often use fentanyl and propofol together, the combination can be dangerous. “In a dark room, having any narcotic present is increasing the patient’s risk a bit, unless there is someone dedicated to monitoring the patient,” said Art Saus, MD, assistant professor of anesthesiology at Louisiana State University Health Center, in Shreveport, who was not involved with this study. EGD often is conducted in dimly lit rooms, which makes it difficult to see when a patient’s breathing has slowed, he said. For this study, a nurse anesthetist or an anesthesiologist monitored the cardiovascular and respiratory parameters, and remained in the room for the duration of the procedure, Dr. Hannallah said. Patients in both groups were given additional boluses of propofol 20 mg in 1- to 2-minute intervals until an adequate depth of anesthesia was achieved. The final propofol induction dose was 1.6 mg/kg for the combined propofol and fentanyl group and 2.5 mg/kg for the propofol-only group. Doctors judged the depth of anesthesia using a soft rubber nasal airway, which was inserted deep into the oropharynx to test the patient’s response. Then an infusion of propofol 150 mcg/kg/min was initiated. The infusion rate was regulated to maintain the proper depth of anesthesia for the procedure. To blind the study to the researchers, pharmacists packaged the drugs. “Everybody received an injection that the pharmacist made for us that had either saline [control] or fentanyl. If the first syringe had fentanyl in it, the pharmacy diluted the propofol,” Dr. Hannallah said. The two drugs look different. Propofol is milky white, whereas fentanyl resembles water. Both fentanyl and saline are clear. Distinguishing between propofol and diluted propofol would probably be difficult. “I doubt that the dilution would be so much that an observer would be able to see the difference,” Dr. Saus said. The endoscopists evaluated the patients using a 10-point scale (10 = no response at all, 1 = patient’s airway needed to be rescued). Out of 50 patients, 44 in the combined propofol and fentanyl group had a score of 9

or 10; 31 in the propofol-only group had these scores. The mean score was 9.6 for the combination patients, and was 8.3 for the propofol-onlyy patients. The lowest-scoringg cases, those rated 4 or less, belonged to three patients in the propofol-only group. None of the patients in the combined propofol and fentanyl group scored below 5. One patient was excluded in each group because of inadequate data. Dr. Saus was concerned by the description of an infusion rate that

was adjusted as needed to maintain “adequate depth,” as it was not clear who determined that depth or how it was defined. Some anesthesiologists use a Richmond Agitation Sedation Scale (RASS) score to measure sedation. The type of scale used was not stated in the abstract. In addition to the endoscopists’ evaluations, all of the patients were phoned within a week of the procedure and asked whether they experienced drowsiness or nausea and

vomiting after the procedure. The patients’ overall evaluation scores showed no significant difference on a 10-point scale (average 9.3 for fentanyl with propofol, 9.5 for propofol alone). Similarly, differences in hypoxia and hypotension between groups were not significant. Dr. Hannallah said he is now “much less antagonistic toward fentanyl” after completing this study. —Shannon Firth

Experience the power of predictable control 1- 4

See how Remi could work for you. Visit booth #1602 at ASA. *Remifentanil is commonly referred to as Remi by anesthesia providers. †Continuous infusions of Remi should be administered only by an infusion device and continuous monitoring is necessary. Interruption of infusion will result in rapid offset of effect. ‡Within 5 to 10 minutes after discontinuation of Remi, no residual analgesic activity will be present. However, respiratory depression may occur in some patients up to 30 minutes after termination of infusion due to residual effects of concomitant anesthetics. Other analgesics should be administered prior to discontinuation of Remi where postoperative pain is anticipated. INDICATIONS ULTIVA® (remifentanil HCl) for Injection is indicated for intravenous administration: • As an analgesic agent for use during the induction and maintenance of general anesthesia for inpatient and outpatient procedures • For continuation as an analgesic into the immediate postoperative period in adult patients under the direct supervision of an anesthesia practitioner in a postoperative anesthesia care unit or intensive care setting • As an analgesic component of monitored anesthesia care in adult patients

ULTIVA is a registered trademark of Glaxo Group Limited. The Mylan logo is a registered trademark of Mylan Inc.

IMPORTANT RISK INFORMATION Continuous infusions of ULTIVA should be administered only by an infusion device. IV bolus administration of ULTIVA should be used only during the maintenance of general anesthesia. In nonintubated patients, single doses of ULTIVA should be administered over 30 to 60 seconds. Interruption of an infusion of ULTIVA will result in rapid offset of effect. Rapid clearance and lack of drug accumulation result in rapid dissipation of respiratory depressant and analgesic effects (within 5 to 10 min) upon discontinuation of ULTIVA at recommended doses. Discontinuation of an infusion of ULTIVA should be preceded by the establishment of adequate postoperative analgesia particularly where postoperative pain is anticipated. Vital signs and oxygenation must be continuously monitored during ULTIVA administration. ULTIVA produces adverse events that are characteristic of μ-opioids, such as respiratory depression, apnea, tachycardia, bradycardia, hypotension,

ULT-2014-0026

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CLINICAL ANESTHESIOLOGY

Risk for Falls Higher in THA and TKA Patients With Nerve Blocks San Francisco—Continuous peripheral nerve blocks (CPNBs) have made tremendous inroads in controlling pain after total hip and knee arthroplasty, but they carry a significant caveat: Patients who receive the blocks may be at increased risk for falling. That risk has been quantified in a trial by researchers at the University of California, San Diego (UCSD), which

found that nearly 3% of patients given CPNBs fell during their hospitalization, despite a nationwide emphasis on fall prevention. “We all wrote about the benefits of continuous femoral nerve blocks after total knee arthroplasty, but as with everything there were unintended consequences,” said Brian M. Ilfeld, MD, MS, professor of anesthesiology at

UCSD, who led the study. “In this case, we observed the occasional fall during randomized controlled trials. But randomized controlled trials often don’t give us real-world answers, so we wanted to see how fall numbers were at our institution before and after we implemented a fall prevention program.” Physicians at UCSD used oral, IV and epidural analgesics to help control

Remi* is a potent μ-opioid agonist with rapid analgesic onset and peak effect, and short duration of action.†1

Rapid response†1

Early post-op neurological assessment‡3,4

Rapid recovery‡1

No accumulation1

Established hemodynamic proﬁle1,2 Remi produces adverse events that are characteristic of μ-opioids, such as respiratory depression, apnea, tachycardia, bradycardia, hypotension, hypertension, and skeletal muscle (including chest wall) rigidity. Please see Indications and Important Risk Information below, and accompanying brief summary of Prescribing Information on adjacent page for all precautions, warnings, contraindications, and adverse events. hypertension, and skeletal muscle (including chest wall) rigidity. Because these effects are dose-dependent and can occur rapidly, continuous monitoring is necessary. ULTIVA should not be used as a sole agent because loss of consciousness cannot be assured and because of a high incidence of apnea, muscle rigidity, and tachycardia. ULTIVA should be used with caution in pediatric, geriatric, and morbidly obese patients due to high variability in pharmacodynamics and dose/response. Intraoperative awareness has been reported with concomitant administration with propofol infusion ≤75 mcg/kg/min. Failure to adequately clear the IV tubing to remove residual ULTIVA has been associated with the appearance of respiratory depression, apnea, and muscle rigidity upon the administration of additional ﬂuids or medications through the same IV tubing.

September 2014

Due to the presence of glycine in the formulation, ULTIVA is contraindicated for epidural or intrathecal administration. ULTIVA is also contraindicated in patients with known hypersensitivity to fentanyl analogs. ULTIVA SHOULD BE USED IN A CAREFULLY MONITORED SETTING BY SPECIFICALLY TRAINED PERSONS NOT INVOLVED IN THE SURGICAL OR DIAGNOSTIC PROCEDURE. OXYGEN SATURATION IS TO BE CONTINUOUSLY MONITORED. RESUSCITATIVE AND INTUBATION EQUIPMENT, OXYGEN, AND AN OPIOID ANTAGONIST MUST BE READILY AVAILABLE. References: 1. ULTIVA [package insert]. Rockford, IL: Mylan Institutional LLC; 2011. 2. Twersky RS, et al. J Clin Anesth. 2001;13(6):407-416. 3. Wilhelm W, et al. Br J Anaesth. 2001;86(1):44-49. 4. Bilotta F, et al. Eur J Anaesth. 2007;24(2):122-127.

pain after arthroplasty between 2003 and 2005. This changed in 2006, when continuous femoral and psoas compartment blocks were instituted. To quantify the incidence of falls, the researchers extracted data from quality-control records and an orthopedics database. Data were compared from three years before (2003-2005) see nerve blocks page 84

74 I AnesthesiologyNews.com

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Deep Sedation Outside the OR Safely Performed by Non-MDs Montreal—Serious injuries following propofol seda tion outside the operating room (OR) by non-anesthesiologist health care practitioners are very rare, a Dutch study has concluded. The investigators also found that non-serious adverse events (AEs) were fairly commonplace, however, suggesting room for improvement during sedation procedures.

ULTIVA® for Injection

Benedikt Preckel, MD, professor of anesthesiology at the Academic Medical Center of Amsterdam, Netherlands, noted that propofol is frequently used for deep sedation outside the OR. In the Netherlands, qualified sedation practitioners akin to nurse anesthetists perform moderate to deep sedation using propofol and opioids. To help determine the safety and quality

(remifentanil hydrochloride) For IV Use Only Rx only Brief Summary: The following is a brief summary only. Before prescribing, see complete ULTIVA prescribing information. CONTRAINDICATIONS Due to the presence of glycine in the formulation, ULTIVA is contraindicated for epidural or intrathecal administration. ULTIVAA is also contraindicated in patients with known hypersensitivity to fentanyl analogs. WARNINGS AND PRECAUTIONS Continuous infusions of ULTIVA should be administered only by an infusion device. IV bolus administration of ULTIVA should be used only during the maintenance of general anesthesia. In nonintubated patients, single doses of ULTIVA should be administered over 30 to 60 seconds. Interruption of an infusion of ULTIVA will result in rapid offset of effect. Rapid clearance and lack of drug accumulation result in rapid dissipation of respiratory depressant and analgesic effects upon discontinuation of ULTIVA at recommended doses. Discontinuation of an infusion of ULTIVA should be preceded by the establishment of adequate postoperative analgesia. Injections of ULTIVA should be made into IV tubing at or close to the venous cannula. Upon discontinuation of ULTIVA, the IV tubing should be cleared to prevent the inadvertent administration of ULTIVA at a later point in time. Failure to adequately clear the IV tubing to remove residual ULTIVA has been associated with the appearance of respiratory depression, apnea, and muscle rigidity upon the administration of additional fluids or medications through the same IV tubing. USE OF ULTIVA IS ASSOCIATED WITH APNEA AND RESPIRATORY DEPRESSION. ULTIVA SHOULD BE ADMINISTERED ONLY BY PERSONS SPECIFICALLY TRAINED IN THE USE OF ANESTHETIC DRUGS AND THE MANAGEMENT OF THE RESPIRATORY EFFECTS OF POTENT OPIOIDS, INCLUDING RESPIRATORY AND CARDIAC RESUSCITATION OF PATIENTS IN THE AGE GROUP BEING TREATED. SUCH TRAINING MUST INCLUDE THE ESTABLISHMENT AND MAINTENANCE OF A PATENT AIRWAY AND ASSISTED VENTILATION. ULTIVA SHOULD NOT BE USED IN DIAGNOSTIC OR THERAPEUTIC PROCEDURES OUTSIDE THE MONITORED ANESTHESIA CARE SETTING. PATIENTS RECEIVING MONITORED ANESTHESIA CARE SHOULD BE CONTINUOUSLY MONITORED BY PERSONS NOT INVOLVED IN THE CONDUCT OF THE SURGICAL OR DIAGNOSTIC PROCEDURE. OXYGEN SATURATION SHOULD BE MONITORED ON A CONTINUOUS BASIS. RESUSCITATIVE AND INTUBATION EQUIPMENT, OXYGEN, AND AN OPIOID ANTAGONIST MUST BE READILY AVAILABLE. Respiratory depression in spontaneously breathing patients is generally managed by decreasing the rate of the infusion of ULTIVA V by 50% or by temporarily discontinuing the infusion. Skeletal muscle rigidity can be caused by ULTIVA and is related to the dose and speed of administration. ULTIVA may cause chest wall rigidity (inability to ventilate) after single doses of >1 mcg/kg administered over 30 to 60 seconds, or after infusion rates >0.1 mcg/kg/min. Single doses <1 mcg/kg may cause chest wall rigidity when given concurrently with a continuous infusion of ULTIVA. Muscle rigidity induced by ULTIVA should be managed in the context of the patient’s clinical condition. Muscle rigidity occurring during the induction of anesthesia should be treated by the administration of a neuromuscular blocking agent and the concurrent induction medications. Muscle rigidity seen during the use of ULTIVA in spontaneously breathing patients may be treated by stopping or decreasing the rate of administration of ULTIVA. Resolution of muscle rigidity after discontinuing the infusion of ULTIVA occurs within minutes. In the case of life-threatening muscle rigidity, a rapid onset neuromuscular blocker or naloxone may be administered. ULTIVA should not be administered into the same IV tubing with blood due to potential inactivation by nonspecific esterases in blood products. PRECAUTIONS Vital signs and oxygenation must be continually monitored during the administration of ULTIVA. General: Bradycardia has been reported with ULTIVA and is responsive to ephedrine or anticholinergic drugs, such as atropine and glycopyrrolate. Hypotension has been reported with ULTIVA and is responsive to decreases in the administration of ULTIVA or to IV fluids or catecholamine (ephedrine, epinephrine, norepinephrine, etc.) administration. Intraoperative awareness has been reported in patients under 55 years of age when ULTIVA has been administered with propofol infusion rates of ≤ 75 mcg/kg/min. Rapid Offset of Action: WITHIN 5 TO 10 MINUTES AFTER THE DISCONTINUATION OF ULTIVA, NO RESIDUAL ANALGESIC ACTIVITY WILL BE PRESENT. However, respiratory depression may occur in some patients up to 30 minutes after termination of infusion due to residual effects of concomitant anesthetics. Standard monitoring should be maintained in the postoperative period to ensure adequate recovery without stimulation. For patients undergoing surgical procedures where postoperative pain is generally anticipated, other analgesics should be administered prior to the discontinuation of ULTIVA. ULTIVA should not be used as a sole agent for induction of anesthesia because loss of consciousness cannot be assured and because of a high incidence of apnea, muscle rigidity, and tachycardia. Pediatric Use: The efficacy and safety of ULTIVA as an analgesic agent for use in the maintenance of general anesthesia in outpatient and inpatient pediatric surgery have been established in controlled clinical trials in pediatric patients from birth to 12 years. In clinical trials, the clearance rate observed in neonates was highly variable and on average was two times higher than in the young healthy adult population. While a starting infusion rate of 0.4 mcg/kg/min may be appropriate for some neonates, an increased infusion rate may be necessary to maintain adequate surgical anesthesia, and additional bolus doses may be required. The individual dose for each patient should be carefully titrated (see ULTIVA Prescribing Information [PI], DOSAGE AND ADMINISTRATION, Table 11). ULTIVA has not been studied in pediatric patients for use as a postoperative analgesic or as an analgesic component of monitored anesthesia care. Geriatric Use: Of the total number of subjects in clinical studies of ULTIVA, 486 were in the age range 66 to 90 years. While the effective biological half-life of remifentanil is unchanged, elderly patients have been shown to be twice as sensitive as the younger population to the pharmacodynamic effects of remifentanil. The recommended starting dose of ULTIVA should be decreased by 50% in patients over 65 years of age. Use in Morbidly Obese Patients: As for all potent opioids, caution is required with use in morbidly obese patients because of alterations in cardiovascular and respiratory physiology. Long-term Use in the ICU: No data are available on the long-term (> 16 hours) use of ULTIVA as an analgesic in ICU patients. Carcinogenesis, Mutagenesis, Impairment of Fertility: Animal carcinogenicity studies have not been performed with remifentanil. Remifentanil did not induce gene mutation in prokaryotic cells in vitroo and was not genotoxic in an in vivoo rat assay. No clastogenic effect was seen in hamster or mouse studies. In the in vitroo mouse lymphoma assay, mutagenicity was seen only with metabolic activation. Remifentanil has been shown to reduce fertility in male rats when tested after approximately 40 times the maximum recommended human dose (MRHD). The fertility of female rats was not affected at IV doses as high as 1 mg/kg when administered for at least 15 days before mating. Pregnancy Category C: Teratogenic effects were not observed in either rats or rabbits following administration of remifentanil at doses up to 400 times and 125 times the MRHD, respectively. Administration of radiolabeled remifentanil to pregnant rabbits

of sedation administered by these practitioners, the investigators used an AE reporting tool designed by the World Society of Intravenous Anaesthesia Sedation Task Force. As part of the trial, the sedation practitioners were asked to complete one form for each deep sedation performed. Data from 1,615 cases were collected during the first eight months

and rats demonstrated significant placental transfer to fetal tissue. There are no adequate and well-controlled studies in pregnant women. ULTIVA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Administration of remifentanil to rats throughout late gestation and lactation at IV doses up to 400 times the MRHD in terms of mg/m2 of body surface area, had no significant effect on the survival, development, or reproductive performance of the F1 generation. Animal Toxicology: Intrathecal administration of the glycine formulation without remifentanil to dogs caused agitation, pain, hind limb dysfunction, and incoordination. These effects are believed to be caused by the glycine. Glycine is a commonly used excipient in IV products and this finding has no relevance for IV administration of ULTIVA. Labor and Delivery: Respiratory depression and other opioid effects may occur in newborns whose mothers are given ULTIVA shortly before delivery. The safety of ULTIVA during labor or delivery has not been demonstrated. Placental transfer studies in rats and rabbits showed that pups are exposed to remifentanil and its metabolites. In a human clinical trial, the average maternal remifentanil concentrations were approximately twice those seen in the fetus. In some cases, however, fetal concentrations were similar to those in the mother. The umbilical arteriovenous ratio of remifentanil concentrations was approximately 30% suggesting metabolism of remifentanil in the neonate. Nursing Mothers: It is not known whether remifentanil is excreted in human milk. After receiving radioactive-labeled remifentanil, the radioactivity was present in the milk of lactating rats. Because fentanyl analogs are excreted in human milk, caution should be exercised when ULTIVA is administered to a nursing woman. ADVERSE EVENTS In controlled clinical trials in approximately 2770 adult patients, ULTIVA produced adverse events characteristic of μ-opioids, such as respiratory depression, bradycardia, hypotension, and skeletal muscle rigidity. These adverse events dissipated within minutes of discontinuing or decreasing the infusion rate of ULTIVA. Table 1: Adverse Events Reported in ≥ 1% of Adult Patients in General Anesthesia Studies* at the Recommended Doses† of ULTIVA Induction/Maintenance Adverse Event Nausea Hypotension Vomiting Muscle rigidity Bradycardia Shivering Fever Dizziness Visual disturbance Headache Respiratory depression Apnea Pruritus Tachycardia Postoperative pain Hypertension Agitation Hypoxia

ULTIVA (n=921)

Alfentanil/ Fentanyl (n=466)

Postoperative Analgesia ULTIVA (n=281)

Morphine (n=98)

After Discontinuation ULTIVA (n=929)

Alfentanil/ Fentanyl (n=466)

8 (<1%) 178 (19%) 4 (<1 % ) 98 (11%)‡ 62 (7%) 3 (<1%) 1 (<1%) 0 0 0

0 30 (6%) 1 (<1%) 37 (8%) 24 (5%) 0 0 0 0 0

61 (22%) 0 22 (8%) 7 (2%) 3 (1%) 15 (5%) 2 (<1%) 1 (<1%) 0 1 (<1%)

15 (15%) 0 5 (5%) 0 3 (3%) 9 (9%) 0 0 0 1 (1%)

339 (36%) 16 (2%) 150 (16%) 2 (<1%) 11 (1%) 49 (5%) 44 (5%) 27 (3%) 24 (3%) 21 (2%)

202 (43%) 9 (2%) 91 (20%) 1 (<1%) 6 (1%) 10 (2%) 9 (2%) 9 (2%) 14 (3%) 8 (2%)

1 (<1%) 0 2 (<1%) 6 (<1%) 0 10 (1%) 2 (<1%) 0

0 1 (<1%) 0 7 (2%) 0 7 (2%) 0 0

19 (7%) 9 (3%) 7 (2%) 0 7 (2%) 5 (2%) 3 (1%) 1 (<1%)

4 (4%) 2 (2%) 1 (1%) 0 0 3 (3%) 1 (1%) 0

17 (2%) 2 (<1%) 22 (2%) 10 (1%) 4 (<1%) 12 (1%) 6 (<1%) 10 (1%)

20 (4%) 1 (<1%) 7 (2%) 8 (2%) 5 (1%) 8 (2%) 1 (<1%) 7 (2%)

*Does not include adverse events from cardiac studies or the neonatal study. See ULTIVA PI, Tables 6, 7, and 8 for cardiac information. † See ULTIVA PI, Table 10 for recommended doses. Not all doses of ULTIVA were equipotent to the comparator opioid. Administration of ULTIVA in excess of the recommended dose (i.e., doses >1 and up to 20 mcg/kg) resulted in a higher incidence of some adverse events: muscle rigidity (37%), bradycardia (12%), hypertension (4%), and tachycardia (4%). ‡ Included in the muscle rigidity incidence is chest wall rigidity (5%). The overall muscle rigidity incidence is <1% when remifentanil is administered concurrently or after a hypnotic induction agent. In the elderly population (> 65 years), the incidence of hypotension is higher, whereas the incidence of nausea and vomiting is lower. DRUG ABUSE AND DEPENDENCE ULTIVA is a Schedule II controlled drug substance that can produce drug dependence of the morphine type and has the potential for being abused. OVERDOSAGE As with all potent opioid analgesics, overdosage would be manifested by an extension of the pharmacological actions of ULTIVA. Expected signs and symptoms of overdosage include: apnea, chest-wall rigidity, seizures, hypoxemia, hypotension, and bradycardia. In case of overdosage or suspected overdosage, discontinue administration of ULTIVA, maintain a patent airway, initiate assisted or controlled ventilation with oxygen, and maintain adequate cardiovascular function. If depressed respiration is associated with muscle rigidity, a neuromuscular blocking agent or a μ-opioid antagonist may be required to facilitate assisted or controlled respiration. Intravenous ﬂuids and vasopressors for the treatment of hypotension and other supportive measures may be employed. Glycopyrrolate or atropine may be useful for the treatment of bradycardia and/or hypotension. Intravenous administration of an opioid antagonist such as naloxone may be employed as a speciﬁc antidote to manage severe respiratory depression or muscle rigidity. Respiratory depression from overdosage with ULTIVA is not expected to last longer than the opioid antagonist, naloxone. Reversal of the opioid effects may lead to acute pain and sympathetic hyperactivity. ULTIVA is a registered trademark of Glaxo Group Limited. US Patent Nos. 5,019,583; and 5,866,591 Version C, 07/2011 Manufactured for Mylan Institutional LLC, Rockford, IL 61103 Manufactured by Hospira, Inc. Lake Forest, IL 60045

of registration, from October 2012 to May 2013. Of these, 811 cases in which an anesthesiologist was not at the scene were analyzed for the incidence of sedation-related AEs. “These are mostly nurse anesthetists,” Dr. Preckel said. “They primarily perform anesthesia on their own. And that’s the key here: to use people who are familiar with airway management and acute hemodynamic changes in case something happens.” Reporting at the 2014 annual meeting of the International Anesthesia Research Society (IARS; abstract S-218), Dr. Preckel said that one or more AEs occurred in 26.6% of all sedations, the most frequent of which were oxygen desaturations. Not surprisingly, AEs occurred more frequently in patients with higher American Society of Anesthesiologists classes, although not to a significant degree. Dr. Preckel also reported that although the reporting tool was used in 92.4% of all sedations, only 48.1% were filled in completely, and AEs were found to be reported correctly in only 60.4% of all completed reports. The assumption at the IARS meeting was that the Dutch findings generally would be mirrored in the United States. As Mark Phillips, MD, said, these results suggest that nonanesthesiologists may be more adept at performing sedation than anesthesiologists give them credit for. “Certainly as anesthesiologists, we think that we’re better at doing sedation than anybody else,” said Dr. Phillips, assistant professor of anesthesiology at the University of Alabama at Birmingham. “But I think this study shows that nurse anesthetists can do it safely, too. There’s actually one study in the gastroenterology literature that shows anesthesiologists had more aspiration during sedation than did gastroenterologists, and that’s probably because a lot of times we’re more used to doing general anesthesia. So we go into an area and we sometimes give too much sedation. “I always say that this type of sedation is the art of anesthesia as opposed to the science of anesthesia,” Dr. Phillips added. “In the Netherlands, not even the gastroenterologists are allowed to perform deep sedations anymore,” Dr. Preckel said. “Now we have an extra, dedicated person for the sedations, and I think that’s the key to minimizing adverse events.” —Michael Vlessides

OCTOBER 2014

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Pre-Hospital Intubation: Initial Success Depends on Model Montreal—Success rates for prehospital emergency intubations using portable video laryngoscopes vary based on the model, a study has found. The German researchers looked at three new portable video laryngoscopes that provide comparable glottis visualization: A.P. Advance (Venner Medical), C-MAC PM (Karl Storz) and King Vision (King Systems). They matched 45 patients (15 for each device), all of whom needed pre-hospital emergency intubation, by gender and body mass index. The average age of patients was 65 years (range, 18-87); 24 were women. All participating physicians were experienced in use of the devices. The most frequent indication for intubation was trauma in 20 cases, including maxillofacial trauma in four cases, and cardiopulmonary resuscitation in nine cases. “We have recently shown that video laryngoscopy for pre-hospitall intubation may be a valuable technique [Emerg [ Med J 2011;28:650-653],” said Erol Cavus, MD, associate professor of anesthesiology at the University Hospital SchleswigHolstein, in Kiel, Germany. “That study used only one device, however. ” Dr. Cavus, reporting at the 2014 annual meeting of the International Anesthesia Research Society, found that glottic visualization was comparable, based on the Cormackk Lehane classification system (abstract S-1; Table).

King Vision (patients, n)

C-MAC PM (patients, n)

A.P. Advance (patients, n)

CormackLehane Class

Table. Glottic Visualization

III

—

The median time to successful intubation, in contrast, showed a marked advantage for both the A.P. Advance (30 seconds; range 10-135) and the C-MAC PM (45 seconds; range 20-90) over the King Vision (70 seconds; range 20-140). “However, I don’t think these differences have a significant clinical impact,” Dr. Cavus said. Most importantly, successful intubation on the first attempt was greatest for both the A.P. Advance, 73%, and the C-MAC PM, 67%, compared with 47% for the King Vision. Overall success

rates for the three devices were 100%, 100% and 60%, respectively. Video laryngoscopy failed in two A.P. Advance patients and one C-MAC PM patient, both of whom were successfully intubated via direct laryngoscopy. Video laryngoscopy failed in six King Vision patients, who were subsequently intubated with a conventional Macintosh laryngoscope.

“We conclude that glottic visualization in video laryngoscopes is comparable with the three different devices,” Dr. Cavus added. “However, especially in this pre-hospital setting, where there are non-standardized conditions, there may be a difference in intubation success rates with different types of video laryngoscopes.” D. John Doyle, MD, PhD, professor

of anesthesiology at the Cleveland Clinic Lerner College of Medicine of Case Western Reserve University, in Ohio, called the study a useful contribution to the literature. “It would be interesting to see how the GlideScope [Verathon]—which has perhaps the largest market share of all the video laryngoscopes—would have compared.” —Michael Vlessides

Protect your hard-earned reputation by managing risk. Since 1987, Preferred Physicians Medical (PPM) has exclusively insured anesthesiologists and their practices. Our policyhold ders also own PPM, so helping our physician owners manage their risk is a cornerstone of what makes us unique. PPM maintains a substantial database of more than 11,000 adverse anesthesia events and uses this information to identify areas of risk, monitor developing loss trends, and provide cutting-edge, timely and praactical anesthesia-specific risk management advice and strategies like: On-site risk management seminars for our po olicyholders and their staff presented by PPM in-house claims attorneys.. Exclusive online access to best practice proto ocols and documentation; white papers; current and archived issues of Anesthesia & Law, our risk management newsletter; and other useful infformation. Immediate email notification via Anesthesia Alerts of issues such as widespread drug contamination, dru ug shortages and significant changes to ASA standards. 24/7/365 telephone access to our experienced d attorneys and claims specialists for the expert risk man nagement advice you need, whenever you need it. Call PPM today to learn more about how our extensivve risk management program can help you protect your reputation.

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p p m r rg . c o m

OCTOBER 2014

Continuing Medical Education

CME WRITTEN BY:

LESSON 312

trial fibrillation is the most commonly encountered and clinically significant cardiac dysrhythmia today. Incidence increases significantly with age, and nearly 1 in 25 individuals over the age of 60 and 1 in 10 over the age of 80 are affected. The number of people with AF in the United States alone is estimated to be more than 2 million and projected to increase 3- to 5-fold by 2050, perhaps exceeding 10 million.1,2 Furthermore, AF is a significant contributor to morbidity and mortality in the elderly. It is associated with an increased incidence of cardiomyopathies, dementia, and cognitive dysfunction, and stroke.3,4 One classification system used to define AF is based on the duration of the dysrhythmia and response to medical and electrical treatments. The system categorizes AF as paroxysmal, recurrent, persistent, or permanent and defines overall treatment strategy (Table 1).3,5 The pathophysiology of AF is multifactorial; a greater understanding of the mechanism of disease and its treatment has evolved over the past decade. Medical therapy involves the use of pharmacologic agents that enable rhythm or rate control. Multiple studies have examined the effectiveness of rate versus rhythm control in the treatment of AF and have indicated similar outcomes.6,7 Traditionally, treatment consists of rate or rhythm control in addition to anticoagulation therapy. The CHAD2 (Congestive heart failure, Hypertension, Age ≥75 years, Diabetes mellitus, Stroke) score is a new stroke-risk stratification system that has been shown to have significant predictive value in facilitating the selection of anticoagulation and antiplatelet therapy (Table 2). A high score indicates a greater risk for stroke.8 However, despite numerous options, treatment of AF is difficult and controversial because of lack of efficacy, risk for side effects, and/or other limitations. A newer theory centers on the idea of a single or few foci located in the proximity of the pulmonary veins that generate the abnormal rhythm. This theory provides the basis for catheter ablation therapy being an effective treatment.9,10

Ablative Therapy Ablative therapy has received significant attention as an alternative therapy for restoration of sinus rhythm. Several studies have shown ablative therapy to be more effective than medical treatment, with a significant decrease in overall morbidity and mortality.11 The 2010 European Society of Cardiology Atrial Fibrillation Guidelines even recommend considering ablation as an initial therapy for paroxysmal AF in selected uncomplicated patients with minimal or no heart disease.12 The recommendation was recently adopted in the 2014 American Heart Association/American College of Cardiology/Heart Rhythm Society (HRS) Guidelines for the Management of Patients with Atrial Fibrillation.13 The foundation for ablative therapy is the belief that AF is the result of a single or few electric foci rapidly discharging through the atria leading to fibrillatory activity. Identifying and ablating these foci, namely the pulmonary veins, enables restoration of sinus rhythm.9 The pulmonary veins are thought to play a key role in the generation of AF. The cardiomyocytes found in the pulmonary veins have pacemaker-type activity; through the mechanism of automaticity and triggering potential they result in spontaneous electrical activity. Typically, 2 catheters, a mapping/ablation and multielectrode, are placed trans-septally in the left atrium via a femoral puncture, which allows the electrophysiologist to record multiple electrical signals from the left atrium and deliver radiofrequency ablation (RFA) lesions. Systemic anticoagulation is accomplished with heparin to prevent clot formation on the catheters, as per the 2012 HRS/European Heart Rhythm Association/European Cardiac Arrhythmia Society guidelines.

Himani V. Bhatt, DO, MPA Assistant Professor of Anesthesiology Icahn School of Medicine at Mount Sinai New York, NY

REVIEWED BY: Michael Greco, DNP, CRNA Assistant Professor of Nursing Columbia University Graduate Program in Nurse Anesthesia New York, NY

Gregory W. Fischer, MD Professor of Anesthesiology Icahn School of Medicine at Mount Sinai New York, NY

DISCLOSURES The authors have no relationships with pharmaceutical companies or manufacturers of products to disclose.

PROFESSIONAL GAPS

James Heilman, MD. Licensed under Creative Commons Attribution

Assessment and Management of the Patient With Atrial Fibrillation for Ablation

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Most anesthesiologists are conversant with the pharmacologic therapy of atrial fibrillation. New theories attempt to identify the cause of this dysrhythmia and indicate that only a few foci are responsible for generating the fibrillatory activity, and, if precisely localized, they can be ablated, resulting in a cure. As medical management has many, sometimes prohibitive side effects, new developments have centered on ablation techniques performed at off-site locations, areas which may not be familiar to the anesthesiologist.

TARGET AUDIENCE Anesthesiologists

CALL FOR WRITERS If you would like to write a CME lesson for Anesthesiology News, please send an email to Elizabeth A.M. Frost, MD, at elzfrost@aol.com.

LEARNING OBJECTIVES At the completion of the activity, the reader will be able to: 1. Differentiate between paroxysmal, persistent, and permanent atrial fibrillation (AF). 2. State the pathophysiology of AF. 3. List risk factors that contribute to morbidity and mortality in patients with AF. 4. List appropriate tests for a patient about to undergo an ablation procedure. 5. Identify the complications/caveats that may accompany procedures for AF. 6. Recognize the signs of cardiac tamponade under general anesthesia. 7. Outline the anesthetic management for an ablation procedure. 8. List the problems encountered in provision of off-site anesthetic care. 9. Name the two electroanatomical technologies used for ablation. 10. Prescribe a plan for postanesthetic care of the patient who has had an ablation procedure.

CASE A 72-year-old man presented to the emergency department complaining of dizziness, shortness of breath, and palpitations that began approximately 24 hours previously while he was playing with his grandson. He had noticed these symptoms on and off for more than 2 months. He had hoped that his usual dose of dronedarone would resolve the palpitations. He had a history of hypertension, diabetes, and AF, for which he was therapeutically anticoagulated with warfarin. During a previous hospitalization for his irregular heartbeat he was treated with “electricity.” He was anxious, dyspneic, and complained of fluttering in his chest. Vital signs included blood pressure, 158/82 mm Hg; pulse, 135 beats per minute and irregular; respiratory rate, 28 breaths per minute; and SpO2 on room air, 95%. Oxygen via nasal cannula was administered at 3 L per minute and a 12-lead electrocardiogram revealed narrow complex tachycardia with an irregular rhythm and no discernible P waves. A cardiac monitor displayed AF. Laboratory tests included a complete blood count, comprehensive metabolic panel, thyroidstimulating hormone, troponin, and coagulation studies. Chest radiography showed cardiomegaly with bilateral pleural effusions consistent with congestive heart failure (CHF). A transthoracic echocardiography showed an ejection fraction of 35%, decreased from 55% 1 year previously, with mild left atrial remodeling but no evidence of left atrial thrombus. After cardiac and electrophysiology consultation, the decision was made to proceed with radiofrequency catheter ablation under general anesthesia.

PREANESTHETIC ASSESSMENT Dr. Elizabeth A.M. Frost, who is the editor of this continuing medical education series, is clinical professor of anesthesiology at the Icahn School of Medicine at Mount Sinai in New York City. She is the author of Clinical Anesthesia in Neurosurgeryy (Butterworth-Heinemann, Boston) and numerous articles. Dr. Frost is past president of the Anesthesia History Association and former editor of the journal of the New York State Society of Anesthesiologists, Sphere. She is also editor of the book series based on this CME program, Preanesthetic Assessment, Volumes 1 through 3 (Birkhäuser, Boston) and 4 through 6 (McMahon Publishing, New York City). A Course of Study for AMA/PRA Category 1 Credit Read this article, reflect on the information presented, then go online (www.mssm.procampus.net) and complete the lesson post-test and course evaluation before September 30, 2015. (CME credit is not valid past this date.) You must achieve a score of 80% or better to earn CME credit. Time to Complete Activity: 2 hours Release Date: October 1, 2014 Termination Date: September 30, 2015 Accreditation Statement The Icahn School of Medicine at Mount Sinai is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. Credit Designation Statement The Icahn School of Medicine at Mount Sinai designates this enduring material for a maximum of 2.0 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity. Faculty Disclosure Statement It is the policy of the Icahn School of Medicine at Mount Sinai to ensure objectivity, balance, independence, transparency, and scientific rigor in all CME-sponsored educational activities. All faculty participating in the planning or implementation of a sponsored activity are expected to disclose to the audience any relevant financial relationships and to assist in resolving any conflict of interest that may arise from the relationship. Presenters must also make a meaningful disclosure to the audience of their discussions of unlabeled or unapproved drugs or devices. This information will be available as part of the course material. Visit www.mssm.procampus.net today for instant online processing of your CME post-test and evaluation form. There is a registration fee of $15 for this non–industry-supported activity. For assistance with technical problems, including questions about navigating the website, call toll-free customer service at (888) 345-6788 or send an email to Customer.Support@ProCEO.com. For inquiries about course content only, send an email to ram.roth@mssm.edu. Ram Roth, MD, is director of PreAnesthetic Assessment Online and assistant professor of anesthesiology at The Icahn School of Medicine at Mount Sinai, New York, NY.

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Continuing Medical Education Carto (Biosense-Webster) and NavX (St. Jude) are the 2 dominant technologies used for electroanatomical mapping. The Carto mapping system uses a magnetic field emitter, which is placed below the patient, and a positional sensor; whereas the NavX system manages electrical signals transmitted between electrode patches on the body’s surface to detect the locations of the catheters. Catheter stability is important to create accurate mapping and ablation. This requires the patient to lie motionless for several hours and the administration of anesthesia is often necessary.

Anesthetic Management The perioperative management of the patient about to undergo an ablation procedure is divided into 3 stages: preanesthetic assessment, anesthetic/sedation management during the procedure, and post-procedural surveillance.

Table 1. Definitions of Atrial Fibrillation Type of Atrial Fibrillation Characteristics Acute

Onset within the previous 48 h.

Paroxysmal

Spontaneous termination within 7 d and most often within 48 h. Paroxysmal AF may degenerate into a sustained form of AF.

Recurrent

≥2 episodes, which may be defined as paroxysmal if they terminate spontaneously or persistent if the arrhythmia requires electrical or pharmacologic cardioversion for termination.

Persistent

Not self-terminating; lasting longer than 7 d, or prior cardioversion. Persistent AF may degenerate into permanent AF.

Permanent

Long-standing AF (defined as >1 y) that is not successfully terminated by cardioversion, when cardioversion is not pursued or has relapsed following termination.

AF, atrial fibrillation

Table 2. CHADS2 Classification Systema C

Congestive heart failure

Recent cardiac failure

Hypertension: blood pressure consistently >140/90 mm Hg (or treated hypertension on medication)

Age ≥75 y

Diabetes mellitus

Prior stroke or TIA or thromboembolism

CHADS, Congestive heart failure, Hypertension, Age ≥75 years, Diabetes mellitus, Stroke; TIA, transient ischemic attack a

The higher the score, the greater the risk.

Preoperative Assessment A complete anesthesia consultation includes engaging the patient, the family, and the electrophysiology (EP) team in a systematic discussion of the anesthetic plan, patient management, and possible complications. Information concerning medical conditions, comorbidities, medications, and previous anesthetic exposures should be elicited from the patient. The type of anesthesia and appropriate monitoring must be discussed with the patient and the EP team. A major goal of any preoperative anesthesia evaluation includes assessment of the medical conditions that may affect the peri-procedural period, identification and management of comorbidities, and prediction of risk–benefit ratios. Once all data have been reviewed, the patient and the family should be educated regarding the anesthetic plan and the possibility of anesthesia-related complications. Patients in AF usually have comorbidities that need to be considered before the procedure, especially underlying cardiac conditions such as hypertension, CHF, angina, and valvular disease. Additionally, the anesthesia team should investigate any pulmonary, renal, and hematologic conditions that may directly affect peri-procedural management. Pulmonary complications can be common after anesthesia and the lengthy procedure can worsen any existing condition. Also, patients who have underlying renal dysfunction may be vulnerable to fluid overload in the EP suite secondary to fluid administration by the anesthesia team, as well as irrigation used by the interventional team over several hours. Finally, patients are often on some form of anticoagulation therapy, which should be identified and coagulation status verified. If the patient is not anticoagulated or treatment is subtherapeutic, transesophageal echocardiography (TEE) before the procedure may be indicated to verify the absence of clot in the atrium. On the other hand, supratherapeutic levels can contribute to bleeding and tamponade. Appropriate tests should be ordered depending on the risk–benefit ratio and identified pathology. Patients with diabetes should have a blood sugar level determined and a potassium value should be known in patients with end-stage renal disease. A thorough preoperative assessment is especially important in remote locations such as the EP suite. Several factors can contribute to a challenging environment for the anesthetic care provider. The fluoroscopy table is difficult to position and the bed controls are at the end of the table under sterile drapes. The fluoroscopy bed is also narrow, and patient positioning and padding is important to areas vulnerable to pressure injury such as the arms, heels, and head, especially in patients who have preexisting neurologic conditions. Special vigilance should be taken when padding the ulna nerve as bulky leads from the multielectrode mapping systems may be stowed under the patient’s elbows. All peripheral IV sites should be assessed for functionality after padding and positioning. Arms that are positioned above the head for lateral imaging should not be extended beyond 90 degrees to prevent brachial plexus injury. Bulky equipment, such as the C-arm x-ray machine and the extensive application of the mapping system patches, further limit access to the patient. The remote location of the EP suite, difficult access to the patient, and EP personnel who are not trained in airway management can make emergency situations more difficult to manage than in the accustomed operating room setting.

Intraoperative Management Atrial fibrillation RFA is a complex procedure and requires a combination of anesthetic management techniques. The North

American Society of Pacing and Electrophysiology has recommended various sedation strategies to safely complete procedures while accounting for the complexities of specific patients and/or procedures.14 The decision to provide conscious sedation, monitored anesthesia care, or general anesthesia is predominantly determined by the anesthesiologist after detailed discussion with the electrophysiologist and the patient. Typically, conscious sedation is used for less complex procedures and involves the administration of benzodiazepines and narcotics; however, patients may not tolerate lengthier procedures with conscious sedation so deeper levels of sedation may be required. In these cases, patient comfort and procedural ease can be enabled by deeper sedation with propofol or dexmedetomidine, a selective a2 adrenergic agonist with centrally mediated sedative effects. However, the longer duration of procedures, discomfort associated with RF energy application and need for patient immobility to provide for catheter stability often require general anesthesia. Evidence suggests that general anesthesia provides for smaller respiratory variations and greater patient immobility enabling better catheter stability, increasing the effectiveness of pulmonary vein isolation and allowing reduced procedure time and lesser procedure difficulty, which together result in greater cure rates.15,16 Standard American Society of Anesthesiologists (ASA) monitors are required, and other invasive monitors—such as direct arterial blood pressure, central venous line, or pulmonary artery catheter placement monitoring—depend on patient comorbidities. Furthermore, AF or the induction of AF during the mapping phase can significantly decrease cardiac output, resulting in hypotension, increased central venous pressure, diminished or absent peripheral pulses, and decreased urinary output. Rapid active IV agents, such as propofol and etomidate, are generally used and titrated for induction based on ventricular function. Etomidate has been a mainstay for induction due to limited inhibition of the sympathetic nervous system and minimal hemodynamic effects. Although no individual anesthetic regimen consistently eliminates pharmacologic complications, the rational use of familiar anesthetic agents that are tailored to the patient’s preoperative status and intraprocedural response is an important factor for ensuring optimal patient outcomes. Following induction and intubation, controlled mechanical ventilation is initiated. Maintenance of anesthesia can be accomplished by IV and/or inhaled agents to maintain an adequate anesthetic depth, amnesia, paralysis, and analgesia. Cardiac motion produced by ventilation can be limited by using highfrequency jet ventilation (HFJV).17 HFJV limits pulmonary excursion, allowing for increased precision with electroanatomical mapping and the ablated lesion. HFJV requires the use of a balanced total IV technique. Additionally, varying degrees of neuromuscular relaxation are required, depending on the procedure. The electrophysiologist may monitor the phrenic nerve during right superior pulmonary vein ablation or cryotherapy to prevent injury requiring the reversal of muscle relaxation.18 Because AF ablation procedures can last from 3 to 6 hours, perioperative hypothermia may become an issue. Hypothermia is linked to a variety of physiologic complications including coagulation disorders, vasoconstriction, myocardial infarction, increased infection, and prolonged recovery. Normothermia should be maintained using both active and passive warming, including heat moisture exchangers; posterior forced-air warming blankets; increased ambient room temperature; and the

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Continuing Medical Education application of warm blankets, socks, and a head cover. As a standard ASA practice, core body temperature should be measured in all patients undergoing general anesthesia.19 Fluid management is important; the choice of fluid and rate of administration must be titrated based on patient need and response. The electrophysiologist can use more than 3 L of 0.9% sodium chloride for injection solution as irrigation during ablation. This irrigation, coupled with fluid given by the anesthesia team, can lead to fluid overload, heart failure, ischemia, and pulmonary edema in patients with underlying cardiac conditions. Administration of fluids should be monitored and diuretics administered as needed. To minimize the risk for stroke from clot formation on the catheters, systemic anticoagulation is initiated with IV heparin and maintained with a heparin infusion. Recommendations note that heparin should be given before trans-septal puncture and infused to maintain an activating clotting time (ACT) of 300 to 400.20 The ACT is usually monitored every 60 minutes and heparin infusion is adjusted accordingly. Protamine is typically given at the end to reverse the effects of heparin based on the final ACT. Complications related to catheter ablative therapy have been reported at 6% and overall mortality has been shown to be as high as 1 in 1000.21 As with most technologies, complications decrease as operator experience grows. Catheter ablation complications can be categorized based on the different stages of the procedure (Table 3). Members of the anesthesia team should be aware of the most frequently encountered complications because many of them can become life threatening. To successfully treat these complications, anticipation, knowledge of when they typically occur, and overall vigilance are essential. Rapid and correct response by the anesthesia team can be lifesaving. Perhaps the most feared complication is the development of pericardial tamponade resulting from iatrogenic injury of cardiac structures during catheter manipulation and ablation. Pericardial tamponade is considered one of the leading causes of procedure-related mortality, with an incidence up to 2.9%. Rapid, unexplained increases in heart rate, refractory hypotension, elevated central venous pressure, and reverse pulsus paradoxus in mechanically ventilated patients (ie, abnormal increase in systolic blood pressure during inspiration compared with expiration) are all nonspecific signs that should alert the clinician to the possibility of tamponade. Diagnostic for tamponade is the presence of a large pericardial effusion with compression of right-sided cardiac structures on echocardiography. Airway management, reversal of anticoagulation with protamine, and the placement of a pigtail catheter into the pericardial space by the EP team are initial steps in management. Vasopressors and/or inotropes, transfusion of blood products and need for surgical intervention may be necessary.

Table 3. Complications of Catheter Ablation Depending on Phase of Procedure Phase

Complications

Anesthesia-related

Suppression of arrhythmias Airway complications Hypoxia Aspiration Hemodynamic abnormalities (hypotension) Positioning complications (nerve injury, myalgias)

Vascular access (femoral/ subclavian/jugular)

Hematoma Retroperitoneal bleeding Pseudoaneurysm Pneumothorax Hemothorax

Arrhythmia induction

Atrial and ventricular arrhythmias Hemodynamic abnormalities (hypotension) Increased central venous pressure Decreased urinary output Diminished peripheral perfusion

Mapping Trans-septal puncture

Atrial perforation (effusion/tamponade) Aortic puncture/dissection Air embolism Thromboembolism Transient ischemic attack Stroke

Catheter manipulation

Atrial tear/perforation Pericardial effusion/tamponade Mitral valve injury

Ablating

Cardiac Mitral valve injury Pulmonary vein stenosis Sinus node injury Atrioventricular block Coronary artery occlusion Myocardial injury (tamponade) Atrial stunning Loss of atrial contractility Fluid retention Pulmonary edema Extracardiac Esophageal injury Atrioesophageal fistula Phrenic nerve injury Vagus nerve injury (pyloric spasm, gastroparesis) Left recurrent laryngeal nerve injury Superior vena cava occlusion

Testing (isoproterenol, adenosine)

Ischemia Atrioventricular block Hypotension/hypertension Bronchospasm Ventricular arrhythmias Tachyarrhythmias Seizure activity Allergic reactions

Removal of access (sheaths, lines, catheters)

Hematoma Retroperitoneal bleeding Pseudoaneurysm

General

Bleeding (tamponade) Embolic events Endocarditis Skin injury/burns

Another rare but feared complication is atrioesophageal fistula resulting from an esophageal thermal injury, which manifests 3 to 6 weeks after the ablative procedure.22 The use of proton-pump inhibitors, continuous monitoring of core body temperature using a 12-sensor probe (ie, S-Cath esophagus probe), and avoidance of delivering high energy close to the esophagus are some preventative measures.23

Postoperative Management Postoperative management does not differ much from that for any other patient recovering from anesthesia, especially if the intraoperative course was uncomplicated. However, due to the fact that most EP labs are not in the main operating room tract, anesthesia recovery areas (postanesthesia care unit) often are insufficient. Proper equipment must be available to monitor vital signs and ensure adequate ventilations and oxygenation. As opposed to classical surgical patients, patients after interventional procedures often are given diuretics because they have received large amounts of irrigation fluid intraoperatively. The administration of diuretics can lead to hypotension in the postoperative period, which responds to fluid boluses and rarely requires pharmacologic intervention. Another hurdle for appropriate postoperative management is the absence of trained personnel. Many EP suites share a recovery unit with the catheterization lab. Most catheterizations are done as outpatient procedures with mild sedation administered by a nursing team and requiring minimal postoperative care. Patients undergoing AF ablation often are under anesthesia for longer periods of time and require greater care and monitoring postoperatively. Staff that is well trained to not only monitor these patients but also to promptly evaluate for complications and initiate a treatment strategy are required. Pain should be controlled in a multimodal fashion. Local anesthetic infiltration at the puncture sites and intraoperative IV narcotics represent the foundation for postoperative pain management. Additional IV narcotics, non-narcotics, and oral analgesics may be used as necessary. Nonnarcotic agents such as IV acetaminophen are useful adjuncts for patients with obstructive sleep apnea (OSA) or chronic obstructive respiratory diseases. Patients with OSA have a higher sensitivity to opiate use, leading to an increased risk for airway compromise in the postoperative period.24 Anesthetic complications can be predictable and often are treated successfully with routine measures. Nonetheless, recovery personnel and the anesthesia team must be vigilant for the serious complications that can occur in the postoperative period, especially those attributable to the ablative treatment itself. Many of these complications occur rapidly and often are diagnosed and treated intraoperatively. But some complications may be delayed and manifest during the postoperative period,

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Continuing Medical Education including femoral pseudoaneurysm with hematoma formation at the site of access, retroperitoneal bleeding, pulmonary vein stenosis, heart block, and even stroke. Pericardial effusion leading to cardiac tamponade is another catastrophic complication that has been shown to occur at least 1 hour after the procedure and may require immediate intervention including pericardiocentesis, pericardial window, or even a sternotomy to evacuate bleeding.25

Hohnloser SH, Kuck K, Lilienthal J. Rhythm or rate control in atrial fibrillation—Pharmacological Intervention in Atrial Fibrillation (PIAF): a randomised trial. Lancet. 2000:356:1789-1794.

16. Firme EBP, Cavalcanti IL, Barrucand L, et al. Curative ablation of atrial fibrillation: comparison between deep sedation and general anesthesia. Revista do Colégio Brasileiro de Cirurgiões. 2012;39:462-468.

Gage BF, Waterman AD, Shannon W, et al. Validation of clinical classification schemes for predicting stroke: results from the National Registry of Atrial Fibrillation. JAMA. 2001;285:2864-2870.

17.

Haïssaguerre M, Jaïs P, Shah DC, et al. Spontaneous initiation of atrial fibrillation by ectopic beats originating in the pulmonary veins. N Engl J Med. 1998;339:659-666.

Management of the Case

10. Chard M, Tabrizchi R. The role of pulmonary veins in atrial fibrillation: a complex yet simple story. Pharmacol Ther. 2009;124:207-218.

In the precatheterization area, benefits and risks from the procedure and anesthesia were discussed with the patient and family and consent was received. A 20-gauge IV cannula was placed. Electrode patches and standard ASA monitors were secured; general anesthesia was induced with midazolam, fentanyl, and propofol; and endotracheal intubation was performed. Mechanical ventilation was initiated with an inspiratory to expiratory time ratio of 1:4; general anesthesia was maintained with desflurane and intermittent boluses of fentanyl. A multisensor temperature probe, the S-cath esophageal probe, was placed in the esophagus for continuous monitoring of core body temperature. Precautions were taken to properly position and pad pressure points on the patient. Heparin was administered and an infusion started with a goal ACT greater than 300. Mapping and ablation of the dysrhythmia was performed for approximately 6 hours. At the end of the procedure, the patient was extubated without any complications and taken to the recovery area, where he was further monitored by the recovery room nurses and transferred to the floor.

11.

Pappone C, Augello G, Sala S, et al. A randomized trial of circumferential pulmonary vein ablation versus antiarrhythmic drug therapy in paroxysmal atrial fibrillation. J Am Coll Cardiol. 2006;48:2340-2347.

12. Camm AJ, Kirchhof P, Lip GYH, et al. Guidelines for the management of atrial fibrillation: the Task Force for the Management of Atrial Fibrillation of the European Society of Cardiology (ESC). Europace. 2010;12:1360-1420. 13. January CT, Wann LS, Alpert JS, et al. 2014 AHA/ACC/HRS Guideline for the Management of Patients With Atrial Fibrillation: a Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the Heart Rhythm Society. J Am Col Cardiol. 2014 Mar 28. [Epub ahead of print] 14. Gaitan BD, Trentman TL, Fassett SL, et al. Sedation and analgesia in the cardiac electrophysiology laboratory: a national survey of electrophysiologists investigating the who, how, and why? J Cardiothorac Vasc Anesth. 2011;25:647-659. 15. Di Biase LD, Conti S, Mohanty P, et al. General anesthesia reduces the prevalence of pulmonary vein reconnection during repeat ablation when compared with conscious sedation: results from a randomized study. Heart Rhythm. 2011;8:368-372.

Raiten J, Elkassabany N, Gao W, et al. Novel uses of high frequency ventilation outside the operating room. Anesth Analg. 2011;112:1110-1113.

18. Bunch TJ, Bruce GK, Mahapatra S, et al. Mechanisms of phrenic nerve injury during radiofrequency ablation at the pulmonary vein orifice. J Cardiovasc Electrophysiol. 2005;16:1318-1325. 19. Nakagawa H, Seres KA, Jackman WM. Limitations of esophageal temperature-monitoring to prevent esophageal injury during atrial fibrillation ablation. Circ Arrhythm Electrophysiol. 2008;1:150-152. 20. 2012 HRS/EHRA/ECAS Expert Consensus Statement on Catheter and Surgical Ablation of Atrial Fibrillation: Recommendations for Patient Selection, Procedural Techniques, Patient Management and Follow-up, Definitions, Endpoints, and Research Trial Design. Europace. 2012;14:528-606. 21. Ashley EM. Anaesthesia for electrophysiology procedures in the cardiac catheter laboratory. Continuing Education in Anaesthesia. Crit Care Pain. 2012;12:230-236. 22. Singh SK, d’Avila A, Stelzer P, et al. Clinical outcomes after repair of left atrial esophageal fistulas occurring after atrial fibrillation ablation procedures. Heart Rhythm. 2013;10:1591-1597. 23. Nair GM, Nery PB, Redpath CJ, et al. Atrioesophageal fistula in the era of atrial fibrillation ablation: a review. Can J Cardiol. 2014;30:388-395. 24. Doufas AG, Tian L, Padrez KA, et al. Experimental pain and opioid analgesia in volunteers at high risk for obstructive sleep apnea. PloS One. 2013;8:e54807. 25. Cappato R, Cappato R, Calkins H, et al. Delayed cardiac tamponade after radiofrequency catheter ablation of atrial fibrillation. J Am Coll Cardiol. 2011;58:2696-2697.

Conclusion Atrial fibrillation is one of the most common dysrhythmias, with nearly 1 in 25 individuals over the age of 60 years and 1 in 10 over the age of 80 affected. The incidence is increasing. Treatment options continue to evolve, including medical, surgical, and interventional treatment modalities. Anesthetic management often is required and involves off-site care in what may be a challenging situation for prolonged periods.

References

Post-Test 1.

Two or more episodes of atrial fibrillation (AF) that terminate spontaneously indicate _____. a. newly diagnosed AF b. recurrent paroxysmal AF c. persistent AF d. permanent AF

What structure plays a central role in AF through the mechanism of automaticity and triggering potential? a. Pulmonary artery b. Pulmonary veins c. Right atrium d. Left atrium

All of the following are common treatment strategies for AF except_____. a. rate control b. glucose control c. rhythm control d. ablative therapy

Complications related to ablation _____. a. occur in up to 6% of cases b. are never fatal c. occur due to inattention by the anesthesiologist d. result in death in 1 in 100 patients

Which statement best describes the treatment of AF? a. Rate control is critical only in newly discovered AF. b. The treatment plan is multifactorial, including consideration of the duration of the current episode of AF. c. Maintaining sinus rhythm is impossible in patients with persistent AF. d. Rhythm control is critical in treating all types of AF.

Atrial fibrillation contributes to morbidity and mortality by increasing the incidence of which of the following? a. Dementia b. Pulmonary embolus c. Diabetes d. Hyperthyroidism

One of the most feared long-term complications in ablative procedures is _____. a. pericardial effusion b. atrioesophageal fistula c. femoral hematoma d. pulmonary edema

Go AS, Hylek EM, Phillips KA, et al. Prevalence of diagnosed atrial fibrillation in adults: national implications for rhythm management and stroke prevention: the AnTicoagulation and Risk Factors in Atrial Fibrillation (ATRIA) Study. JAMA. 2001;285:2370-2375.

Miyasaka Y, Barnes ME, Gersh BJ, et al. Secular trends in incidence of atrial fibrillation in Olmsted County, Minnesota, 1980 to 2000, and implications on the projections for future prevalence. Circulation. 2006;114:119-125.

Calkins H, Brugada J, Packer DL, et al. HRS/EHRA/ECAS expert consensus statement on catheter and surgical ablation of atrial fibrillation: recommendations for personnel, policy, procedures and follow-up. Heart Rhythm. 2007;4:816-861.

Clark DM, Plumb VJ, Epstein AE, et al. Hemodynamic effects of an irregular sequence of ventricular cycle lengths during atrial fibrillation. J Am Coll Cardiol. 1997;30:1039-1045.

Fuster V, Ryden LE, Cannom DS, et al. ACC/AHA/ESC 2006 guidelines for the management of patients with atrial fibrillation executive summary: a report of the American College of Cardiology/American Heart Association Task Force on practice guidelines and the European Society of Cardiology Committee for Practice Guidelines (Writing Committee to Revise the 2001 Guidelines for the Management of Patients with Atrial Fibrillation) developed in collaboration with the European Heart Rhythm Association and the Heart Rhythm Society. Eur Heart J. 2006;27:1979-2030.

When using a CHADS2 score _____. a. a low score indicates increased risk b. the higher the score the greater the risk c. the risk depends entirely on pharmacologic management d. the score does not evaluate for risk

A leading cause of procedure-related mortality in AF ablations is_____. a. pulmonary effusion b. pericardial tamponade c. pulmonary edema d. infection

van Gelder IC, Hagens VE, Bosker HA, et al. A comparison of rate control and rhythm control in patients with recurrent persistent atrial fibrillation. N Engl J Med. 2002;347:1834-1840.

10. What is a nonspecific sign pointing to the possibility of cardiac tamponade? a. Pulsus paradoxus in mechanical ventilated patients b. Decreased central venous pressure c. Hypertension d. Tachycardia

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CLINICAL ANESTHESIOLOGY

Transfusion-Related Acute Lung Injury a Perioperative Hazard (abstract 2228). Thoracic (3%), vascular (2.7%) and transplant (2.2%) surgeries carried the highest rates of TRALI, while obstetric and gynecologic surgical patients had no TRALI episodes during either study year. The rate of TRALI or possible TRALI increased with age (P=0.041) and volume of blood transfused (P<0.001; Table). The incidence of the condition was comparable in men

and women (1.3% vs. 1.1% in 2004; 1.5% vs. 1.4% in 2011; P=0.764). “The increase in incidence with increased transfusion volume is a phenomenon that has been previously described, essentially a dose-related phenomenon,” Dr. Clifford said. “The more blood products you receive, the more likely you are to receive a product that will precipitate a TRALI reaction.”

A University of Toronto research team also investigated the rate of perioperative TRALI, based on data from the Canadian Blood Services (abstract A2226). The investigators reviewed all suspected TRALI cases reported to the organization between 2001 and 2012. A second arm categorized suspected cases as occurring within 72 hours of see TRALI page 82

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San Francisco—Acute lung damage related to blood transfusions continues to affect about one in every 100 surgery patients, despite efforts to reduce the incidence of the life-threatening condition. Anesthesiologists at Mayo Clinic found that the rate of transfusion-related acute lung injury (TRALI) decreased between 2004 and 2011 against a backdrop of various novel mitigation strategies. Another study, in Canada, concluded that almost 40% of reported TRALI cases in that country occurred during the perioperative period. “TRALI is the leading cause of transfusion-related fatalities in the United States,” said Leanne Clifford, BM, MSc, an anesthesia resident at Mayo Clinic, in Rochester, Minn. “We know that approximately 50% of blood products are given in the operating room, and a recent study has suggested that 40% of TRALI episodes occur in the perioperative setting. Despite these facts, nobody has to date specifically studied the patient characteristics and risk factors for TRALI in a surgical population.” To shed light on this area, Dr. Clifford and her colleagues evaluated the records of all patients older than age 18 years undergoing noncardiac surgery and who received transfusions during the procedure (N=3,380). The researchers identified cases by screening patient medical records using a highly sensitive electronic algorithm for the detection of TRALI or possible TRALI (sensitivity, 92.5%; specificity, 93.6%). Two independent physicians then reviewed each positive record. “Where discrepancies arose, a panel of three senior critical care physicians adjudicated the final outcome,” Dr. Clifford said. The cumulative incidence of TRALI and possible TRALI, in 2004 and 2011, was 1.3%. “We found a significantly higher rate of TRALI compared to what has been previously described in the literature,” Dr. Clifford noted. “Interestingly, we did not actually observe a significant decline in the rate of TRALI between 2004 and 2011, before and after the introduction of various mitigation strategies which have been previously well demonstrated to reduce TRALI,” she added. The rate of TRALI varied with the type of surgery, according to the researchers, who first reported their findings at the 2013 annual meeting of the American Society of Anesthesiologists

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82 I AnesthesiologyNews.com

OCTOBER 2014

CLINICAL ANESTHESIOLOGY

Automated Closed-Loop Fluid-Management System Passes Test San Francisco—Having successfully completed simulation, engineering and animal studies, an automated, closed-loop, fluid-management system has been successfully tested in a pilot study in patients undergoing abdominal surgery. The system, developed at the University of California Irvine’s Department of Anesthesiology & Perioperative Care and jointly tested by

American and French researchers, can be both practical and effective, resulting in hemodynamic end points that are, at a minimum, comparable to goaldirected fluid therapy. “Dynamic parameters like pulse pressure variation have been shown to be accurate predictors of fluid responsiveness,” said researcher Marc Lilot, MD, assistant professor of anesthesiology

and intensive care at the Louis Pradel Hospital of the Hospices Civiles de Lyon, in Lyon, France. “In addition, hemodynamic optimization based on fluid management and stroke volume optimization have been shown to improve patient outcomes, especially for moderate- and high-risk abdominal surgical patients.” The closed-loop system—the Learning Intravenous

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Resuscitator (Sironis)—is based on multiparameter hemodynamic monitoring and was tested on 13 patients undergoing elective abdominal surgery between January and March 2013. The 13 patients were compared with 14 case-matched controls with similar baseline body and hemodynamic values. For patients in the closed-loop group, anesthesia providers were asked to give restrictive baseline crystalloid infusions of 3 mL/kg per hour (colloids were administered to closed-loop group patients for intravascular volume expansion). By comparison, patients from the control group were subject to standard goal-directed fluid therapy protocols. In both groups, drugs

TRALI

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CONTINUED FROM PAGE 81

surgery (perioperative) or outside of that period (non-perioperative). The study found that between 2001 and 2012, 303 suspected cases of TRALI were reported to Canadian Blood Services. Of those, 112 (38%) were identified as occurring during the perioperative period. Cardiac surgery requiring cardiopulmonary bypass (25%), general surgery (18%) and orthopedic procedures (12.5%) represented the three largest surgical groups. Patients developing TRALI perioperatively were, on average, transfused more products than non-perioperative patients. Perioperative TRALI patients were also transfused more frozen and fresh frozen plasma and cryoprecipitate than non-TRALI patients. Perioperative TRALI cases were also found to consist of more men (53.6 vs. 41.4; P=0.0395) than non-perioperative Table. Characteristics of TRALI Cases 2004 Age, y

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n (%)

318

3 (0.9)

277

50-59

296

1 (0.3)

288

60-69

415

4 (1.0)

421

70-79

486

8 (1.6)

370

80+

303

6 (2.0)

206

Transfusion volume, mL

@anesthesianews anesthesiology ynews

≤350

606

2 (0.3)

512

351-700

635

2 (0.3)

485

701-1,050

201

3 (1.5)

187

1,051-1,400

130

2 (1.5)

101

≥1,401

246

13 (5.3)

277

OCTOBER 2014

AnesthesiologyNews.com I 83

CLINICAL ANESTHESIOLOGY and transfusions were given at the provider’s discretion. A variety of hemodynamic variables were analyzed, including stroke volume index, cardiac index, heart rate, stroke volume variation and mean arterial pressure. “Because this was a nonrandomized, case-matched study, we didn’t perform any statistical test, which means there are no P values for our data,” said Dr. Lilot, who initially reported these findings at the annual meeting of the American Society of Anesthesiologists (abstract 2034) in 2013. As Dr. Lilot noted, there were no significant differences in demographic and baseline hemodynamic data between groups. And despite the longer duration of anesthesia in the closed-loop group (474 vs. 367 minutes), the closed-loop system was able

TRALI patients. Furthermore, a greater proportion of perioperative TRALI patients required supplemental oxygen (14.3% vs. 3.1%; P=0.0003), required mechanical ventilation (18.8% vs. 3.1%) or were from the ICU (14.3% vs. 3.7%; P=0.0043), than non-perioperative patients before their operations. “Perioperative TRALI is probably something that we need to be more aware of,” Dr. Clifford concluded. “If we can identify TRALI cases in real time, then we may be able to find and investigate the donors, and potentially consider whether they need to be excluded from the donor pool to prevent them precipitating further TRALI reactions in future patients. “It will also enable us to conduct better studies into TRALI’s potential mechanisms, and therefore treat patients in a more timely and appropriate manner.” —Michael Vlessides

011

Overall n (%)

n (%)

3 (1.1)

595

6 (1.0)

3 (1.0)

584

4 (0.7)

6 (1.4)

836

10 (1.2)

5 (1.4)

856

13 (1.5)

5 (2.4)

509

11 (2.2)

4 (0.8)

1118

6 (0.5)

5 (1.0)

1120

7 (0.6)

2 (1.1)

388

5 (1.3)

2 (2.0)

231

4 (1.7)

9 (3.2)

523

22 (4.2)

to maintain a similar stroke volume index (47 vs. 44), with both lower heart rate (68 vs. 80 bpm) and lower stroke volume variation (6% vs. 9%). Overall arterial pressure was lower in this group of patients as well (77 vs. 86 mm Hg). “Total urine output seemed to be higher in the closed-loop group than in the control group,” he added. Hospital length of stay was shorter in the patients in the closed-loop group. As Dr. Lilot explained, the system affords anesthesiologists a sense of

freedom in the operating room. “The goal of the system is that it’s going to be working even if the anesthesiologist is not looking at it constantly and adjusting fluid administration,” he said. “The goal of this system is to assist the anesthesiologist. “So we can say that these results demonstrate the feasibility of the first automated fluid management in abdominal surgery,” Dr. Lilot said. “And it seems that it can be both practical and effective. We now need some other

New in 2014

information to complete the study to assess if there is any difference in outcome, length of stay or hemodynamic parameters.” Girish P. Joshi, MBBS, MD, told Anesthesiology News that, although closed-loop fluid administration may have some benefits, fluid administration is complex and therefore requires assessment of multiple factors other than dynamic variables, such as respiratory variation in stroke volume, systolic blood see fluid page 87

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