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THE INDEPENDENT MONTHLY NEWSPAPER FOR ANESTHESIOLOGISTS AnesthesiologyNews.com • A u g u s t 2 0 1 3 • Volume 39 Number 8
Misplaced Nerve Blocks Frustrate Efforts at Prevention
A
Momentum Builds For Permanent SGR Fix
lthough not as sensational or disastrous as wrong-site surgeries, wrong-site peripheral nerve blocks are potentially dangerous, and according to a 10-year analysis by Pittsburgh researchers, 10 times more common than their surgical counterparts. Yet the problem can be largely— if not entirely—avoided with better planning, vigilance and engagement by the various members of the care team.
Anesthesiologists applaud reform efforts, but want long-standing payment disparity fixed, too
O
n a Thursday in early June, Andy Harris, MD, an anesthesiologist and a Republican congressman from Maryland, convened a meeting for some of his colleagues in the House. The sole topic on the agenda was a bugbear familiar to physicians and lawmakers alike: the Sustainable Growth Rate (SGR) system of physician payment under Medicare. In attendance was Jane Fitch, MD, chair of anesthesiology at the University of Oklahoma Health Sciences Center, in
see wrong page 42
A
“Biological death is not an event, but a process. Anesthesiologists participate in the decision making and the establishment of these criteria and we should establish clear and unequivocal criteria for the diagnosis of death, knowing the emerging ethical implications,” said Ricard Valero, MD, PhD, senior consultant anesthesiologist at the Hospital Clinic de Barcelona, during a presentation in June at the 2013 annual Euroanaesthesia meeting, in Barcelona, Spain. “There needs to be consensus around a practical and concrete definition of death … based on measurable see consensus page 44
E-NEWSLETTER 2013-2014
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Europeans Call for Anesthesiologists To Take Lead in ICU Death Declarations nesthesiologists should play a greater role in the determination of death in the ICU and emergency department to help facilitate organ transplantation and resolve ongoing ethical and medical practice issues, according to a group of European physicians. And because different countries, cultures and religions embrace varying standards, an international consensus is needed to determine when and under what circumstances death has occurred, experts advised. However, they added, such agreement is unlikely given the depth of those differences.
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08 | PRN Inside deadly malpractice.
41 | TECHNOLOGY Saving the livers! New device prolongs viability of transplant organs.
46 | CLINICAL ANESTHESIOLOGY Streamlining surgery for patients on dialysis.
CME: PREANESTHETIC ASSESSMENT Lesson 305: PreAnesthetic Assessment of the Child Requiring Multiple Organ Transplantation, see page 47.
10 | Collaboration Between the Anesthesia and Surgical Teams in the Perioperative Setting
Si
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4 I AnesthesiologyNews.com
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Heard Here First:
August 2013
The five most-viewed articles last month on AnesthesiologyNews.com 1. Disclosing Medical Errors and Adverse Events (blog post) 2. Study Questions Current Hypothermia Quality Measure 3. Online Camera Hookup Links Hospitals to War-Zone Clinicians 4. Into the Mystic: Anesthesia and the Search For Psychological Experience 5. Liver Transplant Anesthesia Guidelines A ‘Landmark’
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The risk for cognitive decline at one month was not lower in the dexamethasone group but it was higher, 14% versus 7% in the placebo group. However, the difference between the groups was
not statistically significant, which is the story of my life.
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AUGUST 2013
AnesthesiologyNews.com I 5
COMME N TA R Y
CMS Directives: Hat or Miss
I
n response to deficiencies reported by the Centers for Medicare & Medicaid Services (CMS) following a recent survey of my hospital, the operating room administration mandated that the traditional surgeon’s cap (referred to in that correspondence as a “skullcap”) could be worn no longer. Only disposable bouffant caps provided by the hospital would be acceptable attire, and all surgeons’ caps were removed from hospital procedural areas. Surgeons (male and female alike) were dumbfounded. The rollout of the new hat policy offered no scientific evidence to justify the decree. This rule affected more than physicians, but nonetheless was received as just one more of the rapidly proliferating, apparently capricious rules governing physician performance, reinforcing the perception that we are being policed by administrators and nurses to prevent us from harming our patients. This new mandate struck a nerve in wiping out a surgical icon—the long white coat and scrubs signify “doctor,” but the skullcap signifies “surgeon.” Not only that, the comfort of the familiar was jettisoned without warning. Somehow this chafes, because despite earning a decent income and reveling in the technical performance of an operation, we have all made, and will continue to make, generous sacrifices of our time and personal comfort in the service of our patients. Many of us have shared the view that CMS surveys result in more particular and yet arbitrary citations than those generally issued by the Joint Commission ( JC)—formerly the Joint Commission on Accreditation of Healthcare Organizations ( JCAHO)— which has tended to emphasize selff improvement, establishing guidelines rather than specific approaches to satisfy established standards. This theme is expressed in the JC’s mission “to continuously improve health care for the public, in collaboration with other stakeholders, by evaluating health care organizations and inspiring them to excel in providing safe and effective care of the highest quality and value.” Historically, the JC accreditation paved the way for CMS accreditation. Although our hospital received exemplary ratings from the JC approximately two years ago, subsequent CMS survey citations seemed contradictory to our favorable JC rating. The CMS survey of our surgery center preceded that of the main hospital and
led to citations for double-glovingg during operations and for using any sort of extension cord even with hospital standard mobile plug towers. This led to the disappearance of all extension cords despite the fact that there were no substitute long cord options for frequently used OR equipment. We wondered if we were required to move the OR table over to the wall outlet in
order to use a lighted, rigid proctosigmoidoscope, one of the more ancient instruments in the hospital and never associated, to my knowledge, with setting patients, drapes or staff on fire or electrocuting anyone! The doubleglovingg citation was unintelligible until the main hospital survey clarified that the under-glove could not be regarded as sterile once the outer glove
was removed. Of course, anyone who has double-gloved for an operation and changed the outer glove when a hole developed in it knows that a major reason for double-glovingg is the risk for single-glove failure. Regarding the surgeon’s cap, deeper investigation into the recommendations by the Association of Operating see CMS page 6
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6 I AnesthesiologyNews.com
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C OMM E NT A R Y CMS
CONTINUED FROM PAGE 5
Room Nurses (AORN) on head coverings in the OR (that formed the basis of the CMS directive), revealed no convincing evidence that hair or scalp exposure in the OR constitutes an infection risk for patients (2010 Perioperative Standards and Recommended Practices. Aseptic Practice. Recommended Practices for Surgical Attire, Recommendation II: “Personnel should cover head and facial hair, including sideburns and necklines, when in the semi-restricted and restricted areas of the surgical suite (page 69).� Whether data support the necessity of a hat at all, common sense would dictate that keeping hair out of the operative field—and out of the operator’s eyes—is reasonable. Even a shortorder cook knows that. The question is “how?� No systematic comparison was made among cap styles to ascertain whether the sanctioned bouffant style more effectively decreases patient exposure to a surgeon’s hair, dandruff or scurf (flakes of exfoliated epidermis) than other hat styles. Nor has the “one hat fits all� standard been evaluated. Long hair slips out of bouffants. I can attest to this personally since during my training, a scrub nurse once instructed the circulator to pull out a few hairs that strayed from my cap! On that occasion (and many others), loose strands have been gently tucked back under the cap during a long case by kinder OR staff. Conversely, what holds the bouffant in place on the near-bald male surgeon? The question of whether we wear a traditional surgeon’s cap or a bouffant bonnet is not just about cap style. Will we choose to step up to the plate and wear the hat of the leader or don the hat of the subordinate? Will we— through our thoughtful dedication to patient care—set the example in the OR, or resign ourselves to being recalcitrant employees who bitterly swallow whatever pill we are administered for fear of diminishing our earnings? Greed; loss of autonomy; preferring to circumvent policies rather than authoring and being the custodians of them; longstanding indulgence of a “boys will be boys� perception of surgeons’ demeanors; failure to reckon with our human limitations so that we become resentful of our demanding work; and loss of connection with the sacred intention that inspired us to pursue our calling to be doctors: These are the ways we undermine ourselves
personally and professionally and diminish our financial value when we withdraw from the system. We sacrifice our integrity and our credibility when we disengage and sidestep meaningless policies rather than challenging and reshaping them to reflect our expertise and values. We fuel the characterization of surgeons as disruptive, childish and disagreeable, and justify the ever-intensifying micromanagement of our performance and policing by administrators,
INDICATIONS ULTIVAÂŽ (remifentanil HCl) for Injection is indicated for intravenous administration: t "T BO BOBMHFTJD BHFOU GPS VTF EVSJOH UIF JOEVDUJPO BOE NBJOUFOBODF PG HFOFSBM BOFTUIFTJB GPS JOQBUJFOU BOE PVUQBUJFOU QSPDFEVSFT t 'PS DPOUJOVBUJPO BT BO BOBMHFTJD JOUP UIF JNNFEJBUF QPTUPQFSBUJWF QFSJPE JO BEVMU QBUJFOUT VOEFS UIF EJSFDU TVQFSWJTJPO PG BO BOFTUIFTJB QSBDUJUJPOFS JO B QPTUPQFSBUJWF BOFTUIFTJB DBSF VOJU PS JOUFOTJWF DBSF TFUUJOH t "T BO BOBMHFTJD DPNQPOFOU PG NPOJUPSFE BOFTUIFTJB DBSF JO BEVMU QBUJFOUT 6-5*7" JT B SFHJTUFSFE USBEFNBSL PG (MBYP (SPVQ -JNJUFE 5IF .ZMBO MPHP JT B SFHJTUFSFE USBEFNBSL PG .ZMBO *OD
IMPORTANT RISK INFORMATION $POUJOVPVT JOGVTJPOT PG 6-5*7" TIPVME CF BENJOJTUFSFE POMZ CZ BO JOGVTJPO EFWJDF *7 CPMVT BENJOJTUSBUJPO PG 6-5*7" TIPVME CF VTFE POMZ EVSJOH UIF NBJOUFOBODF PG HFOFSBM BOFTUIFTJB *O OPOJOUVCBUFE QBUJFOUT TJOHMF EPTFT PG 6-5*7" TIPVME CF BENJOJTUFSFE PWFS UP TFDPOET *OUFSSVQUJPO PG BO JOGVTJPO PG 6-5*7" XJMM SFTVMU JO SBQJE PGGTFU PG FGGFDU 3BQJE DMFBSBODF BOE MBDL PG ESVH BDDVNVMBUJPO SFTVMU JO SBQJE EJTTJQBUJPO PG SFTQJSBUPSZ EFQSFTTBOU BOE BOBMHFTJD FGGFDUT XJUIJO UP NJO VQPO EJTDPOUJOVBUJPO PG 6-5*7" BU SFDPNNFOEFE EPTFT %JTDPOUJOVBUJPO PG BO JOGVTJPO PG 6-5*7" TIPVME CF QSFDFEFE CZ UIF FTUBCMJTINFOU PG BEFRVBUF QPTUPQFSBUJWF BOBMHFTJB QBSUJDVMBSMZ XIFSF QPTUPQFSBUJWF QBJO JT BOUJDJQBUFE 7JUBM TJHOT BOE PYZHFOBUJPO NVTU CF DPOUJOVPVTMZ NPOJUPSFE EVSJOH 6-5*7" BENJOJTUSBUJPO 6-5*7" QSPEVDFT BEWFSTF FWFOUT UIBU BSF DIBSBDUFSJTUJD PG ç PQJPJET
ÂŞ .ZMBO *OTUJUVUJPOBM
6-5 +"
AUGUST 2013
AnesthesiologyNews.com I 7
COMME N TA R Y nurses, and nearly anyone else inside or outside the hospital. We must find the character and conviction to creatively reinvigorate the culture of surgery, our guild, and find meaningful connections with the other professionals whose scope of work overlaps our own. We must understand that our ability, not only to respond to pointless legislation but also to assume our appropriate place in the determination of sound surgical practices, will serve us well. It will enhance our
On Off
gratification by deepening our connection to our calling and make us value our work and ourselves, so that we stop agreeing to do more and more with less and less. Although the CMS hat initiative at our hospital apparently has not affected many others yet, it will. The cap is a fitting emblem of our specialty and our identity. At the end of the day, whether we figure out that one cap does or does not fit all, I intend to think critically about my value as
when you want it. when you don’t.
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Visit www.aboutULTIVA.com to see where Remi could work for you. Please see Indications and Important Risk Information below and accompanying brief summary of Prescribing Information on next page for all precautions, warnings, contraindications, and adverse events.
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Ăľ NDH LH NJO 'BJMVSF UP BEFRVBUFMZ DMFBS UIF *7 UVCJOH UP SFNPWF SFTJEVBM 6-5*7" IBT CFFO BTTPDJBUFE XJUI UIF BQQFBSBODF PG SFTQJSBUPSZ EFQSFTTJPO BQOFB BOE NVTDMF SJHJEJUZ VQPO UIF BENJOJTUSBUJPO PG BEEJUJPOBM n VJET PS NFEJDBUJPOT UISPVHI UIF TBNF *7 UVCJOH
%VF UP UIF QSFTFODF PG HMZDJOF JO UIF GPSNVMBUJPO ULTIVA is contraindicated for FQJEVSBM PS JOUSBUIFDBM BENJOJTUSBUJPO 6-5*7" JT BMTP DPOUSBJOEJDBUFE JO QBUJFOUT XJUI LOPXO IZQFSTFOTJUJWJUZ UP GFOUBOZM BOBMPHT 6-5*7" 4)06-% #& 64&% */ 5)& $"3&'6--: .0/*503&% 4&55*/( #: 41&$*'*$"--: 53"*/&% 1&340/4 /05 */70-7&% */ 5)& 463(*$"- 03 %*"(/045*$ 130$&%63& 09:(&/ 4"563"5*0/ *4 50 #& $0/5*/6064-: .0/*503&% 3&464$*5"5*7& "/% */56#"5*0/ &26*1.&/5 09:(&/ "/% "/ 01*0*% "/5"(0/*45 .645 #& 3&"%*-: "7"*-"#-& 3FNJGFOUBOJM JT DPNNPOMZ SFGFSSFE UP BT 3FNJ CZ BOFTUIFTJB QSPWJEFST References: 1. Data on ďŹ le. Canonsburg, PA: Mylan Institutional; 2012. 2. ULTIVA [package insert]. Rockford, IL: Mylan Institutional LLC; 2011.
a surgeon and an educator and to encourage my associates to do the same, and to remember our original, sacred intention that led each of us down this arduous but amazing path. Let’s think carefully every day about what hat we choose to wear. —Lauren A. Kosinski, MD, MS Dr. Kosinski is assistant professor of surgery at the Medical College of Wisconsin, in Milwaukee. This essay first appeared in General Surgery News.
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AUGUST 2013
PRN
Inside a Clinician’s Worst-Case Scenario: Deadly Malpractice
the Medical Board of California. “But when physicians are bad, they tend to be very bad.” In California, as in many states, medical board investigations can take many forms, including gross negligence or Washington—Disciplinary action of state medical board action, the that, unlike most he has seen, it had incompetence, sexual misconduct, unlimay be an anesthesiologist’s worst process can be extraordinarily stress- a happy ending. censed practice of medicine, prescripnightmare, but for most clinicians ful. In a presentation at the 2012 “Most physicians try to do the right tion drug violations and fraud. Such it remains just that—a prospect annual meeting of the American thing when it comes to their profession,” investigations begin when a complaint unhitched from reality. Society of Anesthesiologists, Ron- said Dr. Wender, r co-chair of anesthesi- is received by the board’s central comYet for the few physicians who ald H. Wender, MD, dissected one ology at Cedars-Sinai Medical Center, plaints unit, which first determines if stand to lose their license as a result such case, but was glad to report in Los Angeles, and past president of the issue falls under its jurisdiction. Most states make a distinction between cases that are referred to the medical board and those that become and rats demonstrated significant placental transfer to fetal tissue. There are no adequate and well-controlled studies in pregnant ULTIVA® for Injection civil or criminal lawsuits. Medical women. ULTIVA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. (remifentanil hydrochloride) board investigations do not have depoAdministration of remifentanil to rats throughout late gestation and lactation at IV doses up to 400 times the MRHD in terms of For IV Use Only Rx only 2 mg/m of body surface area, had no significant effect on the survival, development, or reproductive performance of the F generation. sitions; discovery often occurs through 1 Brief Summary: The following is a brief summary only. Before prescribing, see complete ULTIVA prescribing information. Animal Toxicology: Intrathecal administration of the glycine formulation without remifentanil to dogs caused agitation, pain, hind CONTRAINDICATIONS record reviews and interviews with the Due to the presence of glycine in the formulation, ULTIVA is contraindicated for epidural or intrathecal administration. ULTIVAA is also 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. affected physician. And while criminal contraindicated in patients with known hypersensitivity to fentanyl analogs. Labor and Delivery: Respiratory depression and other opioid effects may occur in newborns whose mothers are given ULTIVA WARNINGS AND PRECAUTIONS and civil cases can go to trial, medical Continuous infusions of ULTIVA should be administered only by an infusion device. IV bolus administration of ULTIVA should be shortly before delivery. The safety of ULTIVA during labor or delivery has not been demonstrated. Placental transfer studies in rats board cases that are not settled between used only during the maintenance of general anesthesia. In nonintubated patients, single doses of ULTIVA should be administered 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 over 30 to 60 seconds. the parties—as most in fact are—wind similar to those in the mother. The umbilical arteriovenous ratio of remifentanil concentrations was approximately 30% suggesting Interruption of an infusion of ULTIVA will result in rapid offset of effect. Rapid clearance and lack of drug accumulation result in rapid up before an administrative law judge. metabolism of remifentanil in the neonate. dissipation of respiratory depressant and analgesic effects upon discontinuation of ULTIVA at recommended doses. Discontinuation Nursing Mothers: It is not known whether remifentanil is excreted in human milk. After receiving radioactive-labeled remifentanil, Mark F. Weiss, JD, an attorney at the of an infusion of ULTIVA should be preceded by the establishment of adequate postoperative analgesia. the radioactivity was present in the milk of lactating rats. Because fentanyl analogs are excreted in human milk, caution should be Injections of ULTIVA should be made into IV tubing at or close to the venous cannula. Upon discontinuation of ULTIVA, the IV tubing exercised when ULTIVA is administered to a nursing woman. Advisory Law Group, in Los Angeles, should be cleared to prevent the inadvertent administration of ULTIVA at a later point in time. Failure to adequately clear the IV ADVERSE EVENTS who specializes in anesthesia practices, tubing to remove residual ULTIVA has been associated with the appearance of respiratory depression, apnea, and muscle rigidity In controlled clinical trials in approximately 2770 adult patients, ULTIVA produced adverse events characteristic of μ-opioids, such upon the administration of additional fluids or medications through the same IV tubing. explained the procedural differences as respiratory depression, bradycardia, hypotension, and skeletal muscle rigidity. These adverse events dissipated within minutes USE OF ULTIVA IS ASSOCIATED WITH APNEA AND RESPIRATORY DEPRESSION. ULTIVA SHOULD BE ADMINISTERED ONLY BY of discontinuing or decreasing the infusion rate of ULTIVA. between medical board cases and civil PERSONS SPECIFICALLY TRAINED IN THE USE OF ANESTHETIC DRUGS AND THE MANAGEMENT OF THE RESPIRATORY EFFECTS † or criminal cases. “The administrative OF POTENT OPIOIDS, INCLUDING RESPIRATORY AND CARDIAC RESUSCITATION OF PATIENTS IN THE AGE GROUP BEING TREATED. Table 1: Adverse Events Reported in ≥ 1% of Adult Patients in General Anesthesia Studies* at the Recommended Doses of ULTIVA SUCH TRAINING MUST INCLUDE THE ESTABLISHMENT AND MAINTENANCE OF A PATENT AIRWAY AND ASSISTED VENTILATION. After law judge hears the case, then writes his Induction/Maintenance Postoperative Analgesia ULTIVA SHOULD NOT BE USED IN DIAGNOSTIC OR THERAPEUTIC PROCEDURES OUTSIDE THE MONITORED ANESTHESIA CARE Discontinuation or her opinion,” said Mr. Weiss, who 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 Alfentanil/ Alfentanil/ also holds an appointment as clinical ULTIVA ULTIVA Morphine ULTIVA A CONTINUOUS BASIS. RESUSCITATIVE AND INTUBATION EQUIPMENT, OXYGEN, AND AN OPIOID ANTAGONIST MUST BE READILY Adverse Event Fentanyl Fentanyl (n=921) (n=281) (n=98) (n=929) assistant professor of anesthesiology AVAILABLE. (n=466) (n=466) Respiratory depression in spontaneously breathing patients is generally managed by decreasing the rate of the infusion of ULTIVA V at the University of Southern Califor0 61 (22%) 15 (15%) 339 (36%) 202 (43%) Nausea 8 (<1%) by 50% or by temporarily discontinuing the infusion. 0 0 16 (2%) 9 (2%) Hypotension 178 (19%) 30 (6%) nia’s Keck School of Medicine, in Los Skeletal muscle rigidity can be caused by ULTIVA and is related to the dose and speed of administration. ULTIVA may cause chest 22 (8%) 5 (5%) 150 (16%) 91 (20%) Vomiting 4 (<1 % ) 1 (<1%) wall rigidity (inability to ventilate) after single doses of >1 mcg/kg administered over 30 to 60 seconds, or after infusion rates Angeles. “This is a suggested course of ‡ 37 (8%) 7 (2%) 0 2 (<1%) 1 (<1%) Muscle rigidity 98 (11%) >0.1 mcg/kg/min. Single doses <1 mcg/kg may cause chest wall rigidity when given concurrently with a continuous infusion 62 (7%) 24 (5%) 3 (1%) 3 (3%) 11 (1%) 6 (1%) Bradycardia action that then goes to the medical of ULTIVA. Muscle rigidity induced by ULTIVA should be managed in the context of the patient’s clinical condition. Muscle rigidity 3 (<1%) 0 15 (5%) 9 (9%) 49 (5%) 10 (2%) Shivering occurring during the induction of anesthesia should be treated by the administration of a neuromuscular blocking agent and board. In California, the medical board 1 (<1%) 0 2 (<1%) 0 44 (5%) 9 (2%) Fever the concurrent induction medications. Muscle rigidity seen during the use of ULTIVA in spontaneously breathing patients may 0 0 1 (<1%) 0 27 (3%) 9 (2%) Dizziness can either adopt the administrative law be treated by stopping or decreasing the rate of administration of ULTIVA. Resolution of muscle rigidity after discontinuing the 0 0 0 0 24 (3%) 14 (3%) Visual disturbance infusion of ULTIVA occurs within minutes. In the case of life-threatening muscle rigidity, a rapid onset neuromuscular blocker or judge’s ruling or toss it out.” 0 0 1 (<1%) 1 (1%) 21 (2%) 8 (2%) Headache naloxone may be administered. ULTIVA should not be administered into the same IV tubing with blood due to potential inactivation Respiratory Physicians who disagree with the by nonspecific esterases in blood products. 1 (<1%) 0 19 (7%) 4 (4%) 17 (2%) 20 (4%) depression decision of the administrative law judge PRECAUTIONS 0 1 (<1%) 9 (3%) 2 (2%) 2 (<1%) 1 (<1%) Apnea Vital signs and oxygenation must be continually monitored during the administration of ULTIVA. 2 (<1%) 0 7 (2%) 1 (1%) 22 (2%) 7 (2%) Pruritus can request a hearing directly in front General: Bradycardia has been reported with ULTIVA and is responsive to ephedrine or anticholinergic drugs, such as atropine 6 (<1%) 7 (2%) 0 0 10 (1%) 8 (2%) Tachycardia of the medical board. “And if you don’t and glycopyrrolate. Hypotension has been reported with ULTIVA and is responsive to decreases in the administration of ULTIVA 0 0 7 (2%) 0 4 (<1%) 5 (1%) Postoperative pain or to IV fluids or catecholamine (ephedrine, epinephrine, norepinephrine, etc.) administration. Intraoperative awareness has been 10 (1%) 7 (2%) 5 (2%) 3 (3%) 12 (1%) 8 (2%) Hypertension like that decision either, you can appeal reported in patients under 55 years of age when ULTIVA has been administered with propofol infusion rates of ≤ 75 mcg/kg/min. 2 (<1%) 0 3 (1%) 1 (1%) 6 (<1%) 1 (<1%) Agitation to the Superior Court,” Dr. Wenderr said. 0 0 1 (<1%) 0 10 (1%) 7 (2%) Hypoxia 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
*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
First Liposuction Case Turns Deadly To help illustrate the process, Dr. Wender described a case that went through both the Medical Board of California and the state’s court system. The physician involved was an anesthesiologist who had been a top student in medical school. After graduation, he joined a group of anesthesiologists performing outpatient procedures. “His very first case was his first liposuction case,” Dr. Wender said. The patient was a 50-year-old woman undergoing multiple cosmetic procedures, including total body liposuction. The surgeon was not a board-certified plastic surgeon. Although the patient
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PR N children in elementary school. After undergoing an extensive rehabilitation program, his license was reinstated with five years’ probation. “He went back to university, did a 12-month pediatric anesthesia fellowship, then six more months of additional OR training.” At first his license was restricted to the hospital setting only, but eventually all restrictions were lifted. “Today,” Dr. Wender said, “he’s working as an attending in a university program.”
Happy endings aside, Mr. Weiss urged physicians to recognize the overlap that can occur between medical board cases and criminal or civil suits. “There are obligations pursuant to your license to cooperate with the medical board,” he told Anesthesiology News. “But physicians need to understand that when they’re making statements to investigators and giving testimony in connection with medical board disciplinary proceedings, they may be impacting their own civil and
criminal liability, since these statements could be admissible against you in court or otherwise compromise your defense. “So, physicians accused of unprofessional conduct have to make sure their defense counsel isn’t simply familiar with medical board procedures, but has an awareness of defending the client against potential criminal and civil liability as well.” —Michael Vlessides
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was otherwise healthy—American Society of Anesthesiologists physical status 1—she failed to inform the team that she had a previous history of arrhythmias. The case was predicted to last eight hours; it dragged on for 12. The patient received a total of nearly 14 L of tumescent solution with lidocaine and epinephrine, plus 19 L of IV fluid. Not long after the case started, the patient’s oxygen saturation and blood pressure both decreased, while her heart rate increased. By 2 p.m., roughly six hours into the procedure, her urine output had decreased. At this point, the patient had received 11 L of IV fluid and 13 L of tumescent anesthetic. The surgeon then began the facelift and brow lift. Shortly after 6 p.m., the patient was described as “swollen,” and had begun leaking serosanguineous fluid from her face. “Soon they were putting on the dressing, and even though the patient was not really awake, she was extubated. Unfortunately, she wasn’t waking up,” Dr. Wender said. The medical team administered naloxone, furosemide and ephedrine. Still hypotensive at 7 p.m., the patient was placed in the Trendelenburg position. The surgeon recommended more fluid, so hydroxyethyl starch was administered. By 10 p.m., emergency services had been called. When the paramedics arrived, they immediately performed CPR—the first time it had been performed on the patient—and reintubated her. Less than 30 minutes later, she was dead. The complaint was filed against both the anesthesiologist and the surgeon, and a judge issued a temporary restraining order, preventing either from practicing until the case was decided. In this case, the prosecution sought revocation of both physicians’ licenses. “You can seek various forms of discipline,” Dr. Wender explained, “but this case was considered heinous enough that they went for revocation of the license, the ultimate discipline.” The administrative law judge recommended revocation. The anesthesiologist, whom Dr. Wender did not identify to preserve his privacy, requested a hearing in front of the medical board, which subsequently upheld the revocation: He lost his license. “Unlike many cases, though, this one has a happy ending,” Dr. Wender said. The anesthesiologist worked for four years as a research assistant at a university anesthesia program and tutored
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Collaboration Between the Anesthesia and Surgical Teams In the Perioperative Setting Merck Consultants Roy G. Soto, MD Professor Oakland University William Beaumont School of Medicine Residency Program Director Department of Anesthesiology Royal Oak, Michigan
David E. Stein, MD Associate Professor and Chief Division of Colorectal Surgery Drexel University College of Medicine Philadelphia, Pennsylvania
Medical Writer Oren Traub, MD, PhD This article was written with significant input, direction, and editorial review by Merck.
(35.7%), unresolved issues (24%), and communication events when key individuals were excluded (20.9%).1 Dr. Soto, who has practiced for more than 10 years, noted that the size of certain medical centers may contribute to communication problems. “At my center alone, there are 87 different locations where anesthesia might be administered,” Dr. Soto said. “That means that you’re working with people every day who you’ve never met before and haven’t yet established a common language for good communication.”
Perspectives of the Anesthesia Provider And the Surgeon A recent survey conducted with surgeons, anesthesiologists, and certified registered nurse anesthetists (CRNAs) from one institution suggests that the level and quality of communication often is perceived differently by team members.2 Awad et al used a validated Likert-scale survey with questions aimed at communication in the operating room (OR) to establish the baseline of communication among surgeons, anesthesiologists, and CRNAs prior to participating in
medical team training. A study objective was to determine if OR communication could be improved through training.2 The study found that anesthesiologists perceived overall communication to be “poor”; nurses viewed communication as “adequate”; and surgeons found communication among OR staff was “good.” The study found that medical team training could improve communication in the OR.2 Similarly, Sexton et al sought to survey operating theatre and intensive care unit staff about attitudes concerning stress, error, and teamwork.3 Using 4 questionnaires that contained a core set of questions whose responses could match across disciplines and countries, researchers evaluated responses from 1,033 doctors, residents, fellows, and nurses from 12 urban hospitals in Italy, Germany, Switzerland, Israel, and the United States.3 Results showed that 62% of surgical staff reported high levels of teamwork with anesthesia staff. Among anesthesia staff, 41% (106 out of 250) reported high levels of teamwork with surgical staff.3 Also, less than 30% of anesthesia residents, anesthesia nurses, and surgical nurses (10%, 26%, and 28%, respectively), and
Introduction Active coordination by different members of the health care team (eg, surgeons, anesthesiologists, and nurse anesthetists) is important during the perioperative period; investigational and anecdotal observations suggest that poor communication among anesthesia professionals, surgeons, and other surgical staff may exist during this period. Lingard et al observed 48 selected surgical procedures at a Canadian hospital center over 3 months in 2003 in order to describe the content and effects of communication events as well as identify common communication failures.1 The authors identified 421 communication events—defined as a verbal or non-verbal exchange between 2 or more surgical team members—and categorized 129 of these events as communication failures in that content of the communication was directed at the wrong team member, had the incorrect goal or intent for the current situation, or was miscommunicated or not communicated due to the physical or temporal situation at the time (eg, a request was inaudible because of an alarm) (Table 1).1 In separate interviews conducted for this article, David E. Stein, MD, associate professor and chief of the Division of Colorectal Surgery at Drexel University College of Medicine in Philadelphia, Pennsylvania, and Roy G. Soto, MD, professor of anesthesiology and director of the residency program at Oakland University William Beaumont School of Medicine in Royal Oak, Michigan, discussed their experience regarding communication among the health care team. “In my experience, one of the things that gets pushed aside during the perioperative period is communication,” said Dr. Stein, who has practiced since 2003. “It’s important to take a step back and communicate with your team members.” In the aforementioned study by Lingard et al, incidents of communication failure (30.6% of the 421 total number of events) were divided into several categories: poor timing (45.7%), missing or inaccurate information communicated
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ANESTHESIOLOGY NEWS • AUGUST 2013
Table 1. Definitions of Types of Communication Failure With Illustrative Examples and Notes Occasion Failures
Definition
Illustrative Example and Analytical Note (In Italics)
Content failures
Problems in the situation The staff surgeon asks the anesthesiologist whether the antibiotics or context of the comhave been administered. At the point of this question, the procedure munication event has been under way for >1 h. As antibiotics are optimally given within 30 min of incision, the timing of this inquiry is ineffective both as a prompt and as a safety redundancy measure.
Audience failures
Insufficiency or inaccuracy apparent in the information being transferred
As the case is set up, the anesthesia fellow asks the staff surgeon if the patient has an ICU bed. The staff surgeon replies that the “bed is probably not needed, and there isn’t likely one available anyway, so we’ll just go ahead.” Relevant information is missing and questions are left unresolved: Has an ICU bed been requested, and what will be the plan if the patient does need critical care and an ICU bed is not available? [Note: classified as a content and purpose failure.]
Purpose failures
Gaps in the composition The nurses and the anesthesiologist discuss how the patient should of the group engaged in be positioned for surgery without the participation of a surgical the communication representative. Surgeons have particular positioning needs so they should be participants in this discussion. Decisions made in their absence occasionally lead to renewed discussions and repositioning upon their arrival.
Failure
Communication events in which the purpose is unclear, not achieved, or inappropriate
During a living donor liver resection, the nurses discuss whether ice is needed in the basin they are preparing for the liver. Neither knows. No further discussion ensues. The purpose of this communication—to find out if ice is required—is not achieved. No plan to achieve it is articulated.
Reprinted with permission from Lingard L, Espin S, Whyte S, et al. Communication failures in the operating room: an observational classification of recurrent types and effects. Qual Saf Health Care. 2004;13(5):330-334.
Article paid for and sponsored by
39% of anesthesia consultants reported high levels of teamwork with consultant surgeons overall.3 In another study, 16 Canadian clinicians (11 anesthesiologists and 5 surgeons) were interviewed in order for researchers to identify beliefs about preoperative testing practices.4 The content of the physicians’ statements was analyzed and separated into relevant conceptual domains. Results found that surgeons and anesthesiologists differed as to who was responsible for ordering tests and how many and which tests should be ordered.4 Also, results showed that surgeons may order tests based on what they perceive relevant for the anesthesiologist, as opposed to directly communicating with the anesthesiologist about which tests would be most relevant.4 This problem can be compounded by the absence of a formalized communications system or an integrated electronic medical records system across different groups. “If I see the patient in my clinic and ordered all the preoperative tests, the results may be sitting on my desk. I have to remember to transmit those results to the anesthesiologist so that they are available when that practitioner evaluates the patient,” Dr. Stein said. “Having those results might prompt the anesthesiologist to order other tests that I didn’t even consider. It doesn’t do any good if we’re not sharing the information we know.”
Improving Communication in the Perioperative Setting In an effort to improve the level and quality of communication, one model often employed by experts is crew resource management or the use of aviation techniques. Principles of this strategy as applied to the perioperative setting include using a preoperative briefing with all surgical staff. In the past 10 years, following the adoption of crew resource management techniques, the aviation industry has experienced a marked decrease in communication-related mistakes.5 Dr. Soto explained that the recent integration of aviation crew resource management techniques into surgical workflow at his institution is helping communication: “In addition to empowering each member of the surgical and anesthesia staff to speak up when they see something during the case, these aviation management techniques also involve immediate review of cases. This enables us to evaluate the case and use that knowledge for our future cases,” he said. “More and more centers are using a formalized preoperative huddle where they explicitly discuss the case, the positioning, and the procedural details and time,” Dr. Stein said. “Knowledge is power: Having this information can help both surgeons and anesthesiologists navigate their intraoperative approach to the patient.” Dr. Soto also described the usefulness of preoperative meetings. “The anesthesiologist may want to obtain more information to prepare an appropriate anesthetic management plan,” he said. “There’s where the ‘preoperative huddle’ may help.”
Physicians also have indicated that documentation and/ or notes derived from a template sometimes can provide further aid in assuring that all the vital information has been obtained and documented.6,7 Finally, several groups of investigators have studied the effect of formalized processes that incorporate these system improvements. For example, Awad et al instituted a dedicated training session (eg, didactic instruction, interactive participation, role-play sessions, training films, and clinical vignettes) for the entire surgical service using crew resource management principles and principles of change management. Additionally, researchers established formal preoperative briefings (Table 2) conducted among the surgeon, the anesthesiologist, and the surgical nurse.2 Four months after conducting the training session and initiation of the preoperative briefing protocol, investigators found briefings occurred preoperatively for all patients, and there was a significant increase in the perceived communication score among anesthesiologists and surgeons (score increase among OR nursing staff was not statistically significant).2 Lingard et al performed a 13-month prospective study of a short team briefing structured by a checklist in order to assess whether these briefings could improve OR communication. Participants included 11 general surgeons, 24 surgical trainees, 41 OR nurses, 28 anesthesiologists, and 24 anesthesia trainees from a Canadian academic tertiary care hospital.8 The primary outcome measure was the total number of communication failures per surgical procedure. During the structured briefings, led by the surgeon, team members were to share their knowledge of the case and resolve knowledge gaps as to how the procedure would proceed.8 Study researchers reported that the mean number of communication failures per procedure declined from 3.95 before the briefing intervention was introduced to 1.31 failures per procedure following the intervention period (P<0.001).8
Conclusion Overall, Dr. Stein noted that the success of these types of interventions begins with the staff members themselves. “Everybody has to check their egos at the door. The days of having a central person saying ‘I know best’ and ‘you should do what I say’ are well past,” he said. “It’s best to have a team that is communicating well with one another.”
References 1. Lingard L, Espin S, Whyte S, et al. Communication failures in the operating room: an observational classification of recurrent types and effects. Qual Saf Health Care. 2004;13(5):330-334. 2. Awad SS, Fagan SP, Bellows C, et al. Bridging the communication gap in the operating room with medical team training. Am J Surg. 2005;190(5): 770-774. 3. Sexton JB, Thomas EJ, Helmreich RL. Error, stress, and teamwork in medicine and aviation: cross sectional surveys. BMJ. 2000;320(7237):745-749. 4. Patey AM, Islam R, Francis JJ, et al. Anesthesiologists’ and surgeons’ perceptions about routine pre-operative testing in low-risk patients:
Table 2. Preoperative Briefing Guide Category
Components
Time out
Patient name Procedure Site verification Laterality
Roll call
Staff surgeon Anesthesiologist Nurse
Anticipated problems Documentation
Consent History and physical within 30 d Staff preoperative note
Case discussion
Anesthesia plans/concerns Allergies IV antibiotics Position Sequential compression device Required instrumentation Special equipment Blood Length of procedure Postoperative disposition Precautions Consensus on plan and site
Reprinted with permission from Awad SS, Fagan SP, Bellows C, et al. Bridging the communication gap in the operating room with medical team training. Am J Surg. 2005;190(5):770-774.
application of the Theoretical Domains Framework (TDF) to identify factors that influence physicians’ decisions to order pre-operative tests. Implement Sci. 2012;7:52. 5. Rivers RM, Swain D, Nixon WR. Using aviation safety measures to enhance patient outcomes. AORN J. 2003;77(1):158-162. 6. Lubarsky D, Candiotti K. Giving anesthesiologists what they want: how to write a useful preoperative consult. Cleve Clin J Med. 2009; 76(suppl 4):S32-S36. 7. Bader AM, Sweitzer B, Kumar A. Nuts and bolts of preoperative clinics: the view from three institutions. Cleve Clin J Med. 2009; 76(suppl 4):S104-S111. 8. Lingard L, Regehr G, Orser B, et al. Evaluation of a preoperative checklist and team briefing among surgeons, nurses, and anesthesiologists to reduce failures in communication. Arch Surg. 2008;143(1):12-17; discussion 18.
Disclosures Both Drs. Soto and Stein were paid by Merck for their contributions to this article. Dr. Soto reported receiving grant/ research support from Merck. Dr. Stein reported receiving speaker fees from Cubist, Ethicon Endo-Surgery, and Merck.
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Disclaimer: This monograph is designed to be a summary of information. While it is detailed, it is not an exhaustive clinical review. McMahon Publishing, Merck, and the authors neither affirm nor deny the accuracy of the information contained herein. No liability will be assumed for the use of this monograph, and the absence of typographical errors is not guaranteed. Readers are strongly urged to consult any relevant primary literature. Copyright © 2013, McMahon Publishing, 545 West 45th Street, New York, NY 10036. Printed in the USA. All rights reserved, including the right of reproduction, in whole or in part, in any form. ANES-1081276-0001 06/13
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What’s Inside Patent Medicines?
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ld apothecary jars, from as far back as the 1880s, fill a back room at the Henry Ford Museum in Dearborn, Mich. Although the museum has an inventory of these patent medicines and old newspaper ads showing the costs of the various items, no one knew what the jars actually contained. Concerned that they might be preserving dangerous substances, museum staff approached Mark Benvenuto, PhD, a chemist at nearby University of Detroit Mercy, to perform the pharmacologic equivalent of a crime scene investigation. Dr. Benvenuto, a professor and the chair of the university’s Chemistry and Biochemistry Department, was curious enough to recruit a team of undergraduates to provide chemical analysis of the ingredients in the old patent medicines. For the unfunded research project, he asked the Henry Ford Museum to choose 25 items it would most want analyzed. Dr. Benvenuto suspects product names were major criteria: Selections included Dr. J.J. Gallop’s Vegetable Family Pills, Parson’s Purgative Pills and Dr. F. G. Johnson’s French Female Pills.
‘If you crank the clock back 120 years, mercury was often used to treat diseases, including syphilis. It would almost kill you, but it actually did kill the spirochete bacteria.’ —Mark Benvenuto, PhD
All photos p otos uunless ess ot otherwise e se noted oted cou courtesy tesy oof tthee U University e s ty oof Kansas a sas Sc School oo oof Pharmacy, a acy, Lawrence. a e ce
What’s in a Patent Medicine? The contents of the museum’s jars “were often unlisted so competitors wouldn’t steal them,” Dr. Benvenuto learned. Some of the ingredients his team found, including an assortment of minerals, are considered helpful today. Diamond Dinner Pills, for instance, were a benign combination of iron, potassium, copper, zinc and calcium. Small amounts of silver often were included, perhaps because colloidal silver was believed to help digestion. “If you crank the clock back 120 years, mercury was often used to treat diseases, including syphilis. It would almost kill you, but it actually did kill the spirochete bacteria,” Dr. Benvenuto said. “If you took a controlled mercury dose, it would probably make you vomit, which may have been the way Parson’s Purgative Pills worked.” He attributes the significant amounts of iron in Dr. F. G. Johnson’s French Female Pills to “an old wives’ tale that said you need more iron when you’re pregnant.” The high mercury and lead content surprised fourth-year mechanical engineering student Andrew Diefenbach, who presented the results of the investigation at the recent annual meeting of the American Chemical Society, in New Orleans. “I knew lots of these [elements] had been in medicine, but didn’t realize how much had been used,” he said. “Lead compounds made things taste sweet— the Romans used it to sweeten food and wine.” Despite often having names that evoked the medical profession—such as Dr. Sawen’s Magic Nervine Pills, Dr. Comfort’s Candy-Covered Cathartic Compills and Dr. Tutt’s Liver Pills—patent medicines were not necessarily created by doctors. They sometimes made outlandish claims (like Rhodes’ Fever & Photo courtesy of Mark Benvenuto, PhD
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PR N Ague Cure or Antidote to Malaria) and misled people about their contents. Whoever produced them, physicians or not, had at least the elementary equipment to make a capsule, Dr. Benvenuto discovered. “They look professional, with gaudy labels we wouldn’t use anymore. But they don’t look like, say, homemade rock candy, either.” Modern-Day Detective Techniques To figure out the amount of each toxic compound in the patent medicines, “we took each sample and bombarded it with x-rays. Different ingredients give off a different radiation, and then you can try to figure out the approximate percentage of each,” Dr. Benvenuto explained. “We ran [tests looking for] 1,000 parts per million of lead, and checked peak intensity. Mercury, arsenic and lead content all seemed to be in that range. Intriguingly, we found the same percentages of calcium and iron.” The next phase of their research will look at inactive or inert ingredients. “We now think of what these people were doing as primitive,” Dr. Benvenuto said. “The inactive ingredients were probably inert, like talc or sugar—things that are not harmful. The
cellulose fillings are still used today, and so is titanium dioxide, the whitener in gum. You don’t need that in your body, though.” Because the inert materials made a pill manageable for holding in one’s fingers, he suspects that “even 120 years ago, people didn’t want a giant capsule.” Phase 2 of the research project will use nuclear magnetic resonance imaging. “We’ll dissolve a [product] sample in a solvent, then spin it at 24 times per minute. It’s kind of a CSI effect,” said Dr. Benvenuto, referring to the popular TV series that uses forensic science to solve crimes. Organic ingredients such as cocaine don’t show up on x-rays, but may be detectable in phase 2. However, “after 100 years, codeine, laudanum, cocaine and opium would break down, so we may not find them,” Dr. Benvenuto conceded.
analysis. Some ingredients we now consider poisons were commonly used. But most drugs are poisonous at some dose.” The University of Kansas has a small pharmacy museum. Its contents, including several hundred bottles, come mainly from local pharmacies that were going out of business and donated long-stored, very old products. Many were sold well into the 20th century. Dr. Audus’ favorites include Blosser’s Cigarettes for Bronchial Asthma, DeWitt’s Toilet Cream (possibly for diaper rash) and Cocaine Drops for Toothaches. The museum has acquired print advertisements for several of the products. In one ad, for a mineral/vitamin combination, a woman laments, “He didn’t even kiss me goodnight last night!” Dr. Audus suspects Vitasafe was a probable Viagra (sildenafil) precursor. A Viagra Precursor? Patent medicines required a prescription; some Kenneth L. Audus, PhD, dean of the University of were made by legitimate drug companies. The Kansas School of Pharmacy, in Lawrence, said these majority of items at the Kansas museum were masspatent medicines existed in a sort of regulatory time produced, according to labels on old bottles. For warp. “These ingredients were accepted at the time, example, Harrower Lab in California produced although today’s laws would block them,” he said. Thyro-Pancreas with Ovaries (dose: one sani-tablet “Products were put together based on experience, not before meals), which may have been a hormone replacement therapy–like preparation. The Merrill Company in Cincinnati, which later became MerrillDow, w made red sugar-coated strychnine sulfate tablets (dose: one tablet). Some of the museum’s mercury tablets are coffinshaped. Years ago, “for poisons, the coffin shape was a warning that it’s dangerous,” Dr. Audus said. Although some products listed their active ingredients, he believes the lists often were incomplete. Strychnine, a popular additive, was used as a stimulant or tonic, “like a high caffeine dose, but more dangerous,” he noted. A hundred years ago, sophisticated controlled clinical trials did not exist. The common practice was to simply combine into a patent medicine all the ingredients currently considered to be the safest and best cure for a particular ailment. Dr. Benvenuto said he is convinced that their prevalence contributed to medical progress. “Nowadays, we start by seeing if a drug can kill certain kinds of cells, then we try it in mice, then dogs, then humans,” he said. “Obviously, we have a better system now, but I think [patent] medicine [put us] on the road to where we are now. Compared to folk cures, it was a first step at being logical.” However, one famous “ingredient” probably did little to advance the science. Although neither museum acquired any snake oil products, they’re not a myth: During his popular performances at Chicago’s 1893 Columbian Exposition, Clark Stanley killed rattlesnakes, allegedly for use in his patent medicine. Stanley had production facilities in Massachusetts and Rhode Island for the product he marketed as Clark Stanley Snake Oil Liniment, “a wonderful pain-destroyingg compound,” product claims stated. In 1917, tests by the U.S. government determined that his product contained mineral oil, red pepper, turpentine and camphor (none extracted from snakes). The Rhode Island Supreme Court fined him $20 for “misbranding.” —Carol Milano
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AUGUST 2013
PRN
Steroids Little Succor for Post-CABG Cognitive Decline Miami Beach, Fla.—Steroids following coronary artery bypass graft do not appear to prevent cognitive (CABG) surgery, a definitive answer decline after cardiac surgery, Dutch to the question remains elusive. researchers have found. The latest study was a secondary Experts said the results, although analysis of the DECS (Dexamethaperhaps disappointing, should not sone for Cardiac Surgery) trial (see come as much surprise given that Anesthesiology News, July 2012, page although researchers have devoted 1). Diederik van Dijk, MD, PhD, a substantial energy on why some cardiac anesthesiologist and intenpatients experience cognitive decline sivist at University Medical Center
Utrecht, in The Netherlands, who headed the work, and his colleagues had theorized that a postoperative inflammatory response might be the culprit. So they randomized 291 patients to determine whether prophylactic administration of 1 mg/kg of dexamethasone could blunt cognitive loss compared with placebo. The answer was no.
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group. However, the difference between the groups was not statistically
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Significant Insignificance It might indeed seem that way for Dr. van Dijk, who was a co-author of the primary trial, “Intraoperative High-Dose Dexamethasone for Cardiac Surgery: A Randomized Controlled Trial,” which yielded a nonsignificant finding ((JAMA 2012;308:1761-1767). That study found that although the 30-day adverse event rate favored dexamethasone over placebo, he said, “the difference was not statistically significant, so it’s a negative trial.”
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“[The] risk for cognitive decline at one month was not lower in the dexamethasone group but it was higher, 14% versus 7% in the placebo group. However, the difference between the groups was not statistically significant, which is the story of my life,” said Dr. van Dijk, who presented the findings at a session of the 2013 annual meeting of the Society of Cardiovascular Anesthesiologists (SCA).
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In the cognitive substudy, the difference in cognitive decline approached significance when Dr. van Dijk’s team controlled for two demographic differences between the groups. Despite the random assignment of 145 patients to steroid treatment and another 146 to placebo, mean age in the treatment group was almost two years younger (63.8 vs. 65.5 years); 17 participants also had diabetes compared with 30 participants in the placebo group. “So one could argue patients in the placebo
AUGUST 2013
AnesthesiologyNews.com I 15
PR N group were at higher risk for postoperative cognitive decline at one month follow-up,” Dr. van Dijk said. The mean standardized cognitive test performance was lower in the dexamethasone group, –0.38 versus –0.13 for placebo, not a statistically significant difference, Dr. van Dijk said. All participants underwent a battery of neuropsychological cognitive testing at baseline, one month after cardiac surgery and 12 months after the procedure. Tests included the Corsi Blocks Task, Grooved Pegboard Task, Trail Making Test, Digit Span Task and the Rey Auditory Verbal Learning Task. The 12-month findings are “more reassuring because most patients have recovered and there is a low risk for cognitive decline in both groups that is not different anymore between the two groups,” said Dr. van Dijk, whose study was supported by a mid-career grant from the SCA. “This is an interesting trial, for which the primary outcomes were first presented at the 2012 Society of Cardiovascular Anesthesiologists annual meeting,” said session moderator Hilary P. Grocott, MD, professor of anesthesiology at the University of Manitoba in Winnipeg, Canada. “This important secondary analysis of cognitive outcome is further interesting as it sheds additional doubt on any significant benefit to steroids on even the softer outcomes such as postoperative cognition. It seems that any way we look at it, steroids appear to have no significant beneficial neurologic effect.” The failure of steroids to alleviate the problem is far from an anomaly. Why some patients experience cognitive decline following CABG surgery has been a mystery for decades. “The heyday of postoperative cognitive dysfunction research was about 10 to 12 years ago, with publications in major journals, showing a high incidence of cognitive decline in the first year and in first five-year follow-up studies,” Dr. van Dijk said. However, results of research in the past decade taught clinical investigators two things, he observed. “We may have overestimated the incidence of the problem. Studies in volunteers show there is considerable variation in cognitive test performance. When you choose the wrong cutoff level for what is normal, you can end up with a high level of false-positive cases. “The other thing we’ve learned is avoiding cardiopulmonary bypass doesn’t really help,” Dr. van Dijk
added ((JAMA 2007;297:701-708; N Engl J Medd 2013;368:1179-1188). “This has been a great disappointment to many of us because it’s so natural to assume that cardiopulmonary bypass is responsible.” Further research is needed. “We need alternate explanations for how cardiac surgery can cause postoperative cognitive decline,” Dr. van Dijk said.
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amarcus@mcmahonmed.com
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P OLI C Y & M A NAGEMENT SGR
20 other providers. “But anesthesiologists can definitely have a say in the part of SGR repeal and payment reform that centers on the quality and delivery of care. We can be the gatekeepers of the perioperative home.”
CONTINUED FROM PAGE 1
Oklahoma City, and president-elect of the American Society of Anesthesiologists (ASA). Dr. Fitch came to speak about the importance to her specialty of both reforming the SGR and in the process, leveling what anesthesiologists feel is a long-standing, federally sanctioned underpayment of their services relative to private insurance. “Picking that base rate is very important, and for our specialty particularly, because of our 33% differential: Other specialties are going to get 80% of commercial payment when they bill Medicare, when anesthesiologists get roughly 31%,” Dr. Fitch told Anesthesiology News. “So we’re telling legislators that we need to be on par with every other specialty before they start making any drastic changes to Medicare.” In effect since 1997, foes of the SGR, and they are many, have been looking for ways to get rid of the system. This year they may well succeed. On May 28, the Energy & Commerce Committee’s Subcommittee on Health released draft legislation that would shift away from both the SGR and fee-for-service reimbursement under Medicare. About one week later, the subcommittee held a hearing on SGR reform and repeal. That recent action follows the February release of a framework for reforming the SGR. The document, which was developed by the Subcommittee on Health of the Ways and Means and Energy and Commerce committees, outlines a three-phase process that would start with freezing Medicare payments to physicians at their current levels for 10 years. This step, the lawmakers wrote, “would increase spending by approximately $138 billion. Such an investment in funds needs to be accompanied by fiscally responsible fundamental reform of the Medicare fee-for-service (FFS) payment system.” How the process will unfold—and indeed whether reformers will succeed—remains to be seen. Some anesthesiologists appear optimistic that the specialty, and patients, will benefit from the effort. “We could raise the bar. If physicians are in the middle of the drive for quality and collecting good data, we could save the health care system a tremendous amount of money and save lives by reducing prreventable morbidity andd mortality,” said Michael Ramsay, MD, chair of thee Department of Anesthesiollogy and Pain Managementt, at Baylor University Mediical Center, in Dallas. Others agree, but see the process as being driven largely by bottom-line eco-nomics. “The real gate-keepers are the payors; they set policy,” said Stanford Plavin, MD, founding member of Ambulatory Anesthesia of Atlanta, a group practice with 20 board-certified anesthesiologists and more than
The Road to Reform The draft bill calls for a repeal of the SGR and a 10-year period of “predictable, statutorily defined payment rates.” It also would reform the Medicare FFS system to move to physician fee-schedule payment updates based on “performance on meaningful, physician-endorsed measures of care quality and participation in clinical improvement activities.” At the same time, “medical specialty societies will develop meaningful quality measures and clinical improvement activities using a standard process” and “performance will be based on both riskk adjusted relative rankings amongst physician specialty peer groups and improvement on quality over time.” Additional payments then would be given to physicians who perform well on quality measures, based on the efficiency of care. Dr. Fitch and other anesthesiologists interviewed for this article expressed concern, however, that the process begins on the right footing, with members of their profession being adequately paid at the outset. “You’ve got to first level the playing field,” said Joseph Answine, MD, a partner with Riverside Anesthesia Associates, in Harrisburg, Pa., and associate professor of anesthesiology at Penn State University Hospital, in Hershey. “Doing this would likely mean a cut in reimbursement for other specialties because the framework says the process has to be budgetneutral, and they’re not going to like that,” added Dr. Answine, a board member of the Pennsylvania Society of Anesthesiologists and an ASA delegate. Dr. Harris agreed that dealing with the payment disparity should be part of SGR reform. “If they’re going to do a lot of reform but anesthesiologists are not able to be paid a higher amount or an amount that has reasonable annual updates, I’m not sure we’re we re improving the situation—it si may be just substituting one bureaaucratic scheme for another,” Dr. Harris told An nesthesiology News. The messagge that emerged from the June 5 heearing was clear: The pressure is n now on physicians to focus increasin ngly on providing more value forr the health care dollars they receivve. For example, Bill Kramer, eexecutive director for national health policy at n th he Pacific Business Group oon Health—which comprises 60 member companies that provide health care coverage to 10 million Americans and their dependents—endorsed the push for reform of physician payment. Dr. Andy Harris (R-Md.)
“Businesses have a big stake in how Medicare works,” Mr. Kramer said. “Large employers want to see physician payment directly tied to the value of the services that are provided. [And] we need new and better performance measures to support a new physician payment system.” Jeffrey B. Rich, MD, immediate past-president of the Society of Thoracic Surgeons (STS) and a former director of the Center for Medicare Management at the Centers for Medicare & Medicaid Services (CMS), also testified. “We recommend that policymakers consider ways to reward providers for incremental steps toward these quality assessment and improvement goals, while allowing these medical professionals whose specialties already have the requisite infrastructure in place [such as participants on the STS National Database] to engage in this new system as soon as possible,” said Dr. Rich. Dr. Ramsayy said he believes the field of anesthesiology must emulate these efforts. “Members of the STS have collaborated to collect their data for many years. They look at their outcomes and come up with best practices. And that’s what we’ve got to do in anesthesia,” he told Anesthesiology News. “We need good data, and we need to reward people who have the best practices.” Cheryl Damberg, PhD, of RAND Corporation’s Office of External Affairs, who also testified, suggested that “Medicare should pay providers using a continuous payment incentive approach so as to incentivize improvement along the continuum of performance.” This is already done by Blue Cross Blue Shield of Massachusetts in its Alternative Quality Contract, in which physicians receive bonuses of 2% to 10% of per-member per-month payments depending on where they are on the performance curve, and also payments for each increment of improvement. “CMS should identify and focus development efforts on 10 to 12 clinical subspecialty areas that contribute to a significant portion of Medicare spending and utilization,” Dr. Damberg said, and work with them “to identify performance gap areas and work to develop those as measures.” She pointed out, in addition, that some alternative payment models, such as accountable care organizations (ACOs), are already in place. ACOs, as well as the ASA’s proposal for projects that fit the “perioperative home” model of anesthesiologists’ services, can pave the way for the process to unfold, Drs. Plavin and Answine said. “Since the expectations are different for different specialties, it’s really hard to have across-the-board performance measures for different specialties and subspecialties, so we’re going to have to try different pilot programs rather than broad-stroke ones, and then come up with a handful of options,” Dr. Plavin said. Dr. Answine agreed. “The bottom line is we all agree the SGR is a broken process,” he said. “The legislators don’t know the best way to fix it—and I’m not saying physicians do, but since we live and breathe it we have a better chance of coming up with something that will work for our patients, us and the health care system in general.” —Rosemary Frei, MSc
Available online @ AnesthesiologyNews.com
Corporate Profiles 18
Anesthesia Business Consultants
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Arizant Healthcare Inc., a 3M Company
21
Cadence Pharmaceuticals
22
Dräger
24
Edwards Lifesciences
26
MAQUET Medical Systems USA
28
Masimo
30
MCMahon Publishing
31
Pacira Pharmaceuticals, Inc.
32
Plexus Information Systems, Inc.
34
Spacelabs Healthcare
36
TeamHealth Anesthesia
38
Teleflex
2013-2014
Corporate Profiles
ANNUAL
ANESTHESIA S S BUSINESS US SS CONSULTANTS CO SU S
A
nesthesia Business Consultants, LLC (ABC) is the largest billing and practice management company dedicated to the complex and intricate specialty of anesthesia and pain management. It is both an Anesthesia Quality Institute Preferred Vendor and a Gold Affiliate with the Medical Group Management Association. Tony Mira, ABC’s founder, president and CEO, has maintained a concentration on providing services exclusively to anesthesia and pain management professionals since the company’s inception more than 30 years ago. ABC distinguishes itself by providing optimal business tools to strengthen business processes and enhance cash flow—all while keeping pace with constant changes in the health care environment. ABC prides itself on the longevity of its client relationships and its ability to customize services to the unique requirements of each practice. ABC offers its clients innovative billing and reimbursement services, as well as valuable practice management tools and solutions that allow them to realize their own particular strategic visions and business plans.
The ABC Management Advantage ABC distinguishes itself through its focus, operational approach and management structure: • Unlike many competitors who continually redefine their market focus, ABC has remained true to its core market of anesthesiologists, certified registered nurse anesthetists and pain management specialists, enhancing the credibility of its insight and advice. • ABC believes its relationship with its clients is a true partnership—a partnership in which ABC not only helps improve the billing process, but also helps the group operate more efficiently in the operating room, and more proactively in its relationship with the hospital. • ABC’s centralized approach allows effective management and oversight, ensuring consistent results. • Managing a business based on the input and expectations of shareholders does not always result in the most appropriate business decision making. Because ABC is privately held, it has much greater flexibility in setting its agenda, managing the business and being responsive to its clients’ needs.
The ABC Service Advantage ABC offers a full range of services designed to meet its clients’ needs, from a specific area of service to an all-encompassing solution partner.
Billing and Reimbursement Services Because all processing is centralized, ABC maintains its high standards for quality control and efficiency, resulting in faster claims resolution and
higher levels of reimbursement. Extensive management reporting options allow both management and client to monitor subtle changes in payer mix and reimbursement patterns. Services include: • Front-end edit and claim-scrubber technology • Patient deductible strategies and solutions • Claim underpayment monitoring and reporting
Management Support Services No one company is more qualified to furnish critical management information and proactively advise practice decision makers. ABC stands alone in its ability to provide a full range of management support services: • Strategic management • Practice management - Practice consulting - Financial services - Quality management (PQRS) - Human resources consulting - Contracting services - Compliance and HIPAA - Education and training
AT A GLANCE ADDRESS 255 West Michigan Ave. Jackson, MI 49201 Phone: (800) 242-1131 Fax: (517) 787-0529
WEBSITES www.anesthesiallc.com www.communiquenews.com
SOCIAL MEDIA http://www.anesthesiallc.com/ easyblog/latest http://twitter.com/AnesthesiaLLC https://www.facebook.com/ anesthesiallc http://www.linkedin.com/company/ anesthesia-business-consultants https://plus.google.com/10046113 4039781832016#100461134039 781832016/posts
The ABC Technology Advantage In order to ensure flexibility with its clients and their varying level of needs, ABC has carefully crafted a portfolio of products to meet its clients’ needs during the entire perioperative process. The most advanced, secure and reliable software designed especially for anesthesia billing and practice management, F1RSTAnesthesia T ™ converts clinical information into claims for reimbursement. This powerful tool supports electronic claims editing to ensure consistently high billing acceptance rates and minimizes manual intervention in payment posting through direct remittance processing. Providers also are able to receive real-time or historical information through F1RSTAnesthesia T ’s web-based technology or advanced data warehousing/data-mining technology. OneSourceAnesthesia is a powerhouse platform that offers an à la carte approach to the complete perioperative process—clients choose the features they need now, and have the peace of mind that comes from knowing OneSourceAnesthesia e is adaptable and that they can add increasing functionality as their needs grow and change. The OneSourceAnesthesia e platform offers: - Patient portal - Electronic medical records (EMR) - Postoperative quality - Call scheduling - Patient satisfaction - Patient monitoring - Meaningful use The primary hardware tool required for ABC’s solution is an Apple iPad. The OneSourceAnesthesia e solution also requires no interaction with the hospital or surgery center’s servers to host the software in any way. These elements, when combined with the intuitive user experience of OneSourceAnesthesia, offer an unparalleled
SERVICES Full-service billing and practice management firm dedicated exclusively to anesthesiologists and pain management physicians.
EMPLOYEES 850+
platform to streamline and automatically incorporate best practices and clinical protocols to any practice. • F1RSTUse is the first full-service electronic health records (EHR) management platform built exclusively for anesthesiologists and pain management specialists to satisfy stage 1 of meaningful use as required to earn the Medicare or Medicaid EHR incentive payment. • The Provider Portal provides information you need to stay competitive and informed. The Provider Portal is now available to clients of ABC and takes advantage of the OneSourceAnesthesia e infrastructure to bring together systems such as: - Meaningful use EHR - Presurgical testing management - iPad EMR - Anesthesia call scheduling - Patient satisfaction surveys - Intraoperative patient monitoring - Anesthesia quality outcomes - OR utilization - Patient portal - Live chat
Tony Mira, President and CEO
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Anesthesiology News • August 2013
This corporate profile was reviewed and approved by Anesthesia Business Consultants.
800.242.1131 info@anesthesiallc.com www.anesthesiallc.com
Make An Educated Decision Information You Need To Be Informed and Stay Competitive Anesthesia Business Consultants (ABC) believes the more you know, the better the decisions you can make. ABC places the highest value on continuing education. As the health care world continues to evolve, offering new technological advances and business models, along with changing laws and regulations, it’s imperative to keep informed. We provide our clients and associates regular updates on what is happening in the world of anesthesiology through our weekly eAlerts. These Alerts highlight the very latest in developments, changing requirements and opportunities and are a complimentary service. If you are interested in receiving these Alerts just send your name, e-mail address, the name of your practice or company, city and state to info@anesthesiallc.com. ABC is also pleased to offer the Communiqué, our quarterly newsletter, to interested individuals. It is available electronically as well as in print. The Communiqué features articles written by industry leaders focusing on the latest hot topics in group management, compliance and future business models for anesthesiologists, nurse anesthetists, pain management specialists and anesthesia practice administrators. We look forward to providing you with many more years of practice management news through the Communiqué and our weekly Alerts. Please log on to ABC’s web site at www.anesthesiallc.com and click on the “Publications” link to view the electronic version of the Communiqué online or to see copies of our previous Alerts.
ABC does not share this list with any third parties nor use it for purposes other than distributing the Alerts, the quarterly Communiqués and the very occasional special announcement. If you have any questions or would like additional information please call 517-787-6440 x 4113, send an email to info@anesthesiallc.com, or visit our website at www.anesthesiallc.com. This communication is for educational informational purposes only and is not intended or offered as legal advice.
2013-2014
Corporate Profiles
ANNUAL
ARIZANT HEALTHCARE C INC., C , A 33M COMPANY CO
S
ince the introduction of 3M™ Bair Hugger™ therapy in 1987, Arizant Healthcare Inc., a 3M company, has continuously developed patient warming solutions that set the standard for innovation and quality. The introductions of the 3M™ Bair Paws™ patient adjustable warming gowns and 3M™ Ranger™ fluid warming systems highlight our commitment to develop ingeniously simple products that make it easier for clinicians to do their jobs while helping to improve patient care. This year we proudly introduce our latest gamechanging technology—the 3M™ SpotOn™ temperature monitoring system—which offers clinicians a non-invasive method to measure patients’ core body temperature accurately throughout the perioperative journey using a single disposable sensor. 3M surgical warming products are safely and effectively used to maintain normothermia for more than 20 million patients each year. We look forward to continuing our partnership with you on the mission to improve patient outcomes through effective patient warming.
3M™ SpotOn™ System (www.SpotOnTemperature.com) The SpotOn temperature monitoring system represents a new standard in core temperature monitoring, simplifying the existing temperature measurement process while delivering accurate temperature measurement typically associated with more invasive methods, such as esophageal, bladder, rectal or PA catheters. The SpotOn system utilizes a single-use sensor placed on the patient’s forehead in the pre-op setting. Temperature is continuously displayed on the system’s control unit, ensuring optimization of warming modalities through real-time temperature data. In addition, a memory chip within the sensor provides a two-hour continuous visual representation of the patient temperature trend on the SpotOn control unit. The sensor stays on the patient—disconnected from the sensor cable and reconnected to another SpotOn control unit at each point of care—to eliminate variability.
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Anesthesiology News • August 2013
The SpotOn system also helps standardize temperature monitoring by eliminating the need for multiple products. The SpotOn system also helps standardize temperature monitoring, eliminating the hassle and costs associated with purchasing, stocking and managing multiple products for the same use.
3M™ Bair Hugger™ Therapy (www.bairhugger.com) Bair Hugger therapy was the first forced-air warming product line, and today it remains the market leader. Forced-air warming therapy is a simple, safe and cost-effective method to prevent unintended hypothermia and its associated complications, which include an increased rate of wound infection,1 increased hospital length of stay2 and higher mortality rates.3 Maintaining perioperative normothermia has been cited by quality improvement initiatives around the world as a key factor in reducing the rate of surgical site infections. Many of these same initiatives include forcedair warming in their definition of active warming. Bair Hugger warming units are used in more than 80% of U.S. hospitals, and more than 165 million patients have experienced the benefits of Bair Hugger therapy. Our ongoing commitment to innovation and patient warming has resulted in a product lineup of 25 single-use Bair Hugger warming blanket models, including five adult and two pediatric underbody series blankets. The Bair Hugger therapy underbody series warms from underneath the patient, addressing a clinical need to prevent unintended hypothermia while providing clinicians full patient access. The full-access underbody blanket is showing rapid acceptance by the trauma community with its ability to be pre-set in the trauma bay and then warm the patient from admission and assessment to computed tomography and into the OR or ICU.
3M™ Bair Paws™ Flex Gown (www.bairpaws.com) The Bair Paws flex gown combines the best of both worlds: the comfort and convenience of the Bair Paws gown with the powerful, proven warming of Bair Hugger upper- and lower-body blankets. With the Bair Paws flex gown, patients arrive in the OR already warm when prewarmed before surgery. The same gown enables upper- or lower-body warming in the OR thanks to effective warming tools built right into the gown. Separate upper and lower inserts allow you to activate warming where you want it, with the upper warming insert including all the features of a Bair Hugger upper body blanket. When the patient is ready for the PACU, simply perforate off the upper body warming “sleeves,” head drape and adhesive strip to provide maximum postoperative comfort while maintaining comfort and clinical warming capabilities. The tools that helped the patient in the OR are now conveniently out of the way.
AT A GLANCE ADDRESS 3M Center, Building 275-4E-01 St. Paul, MN 55144 Phone: (800) 228-3957 Website: www.3M.com/ infectionprevention
PRODUCTS 3M™ Bair Hugger™ therapy; 3M™ Bair Paws™ patient adjustable warming system; 3M™ Ranger™ blood and fluid warming systems; 3M™ SpotOn™ temperature monitoring system
GLOBAL BUSINESS DIRECTOR, PATIENT WARMING Jay Issa
The gown’s flexibility eliminates the costs and hassles of buying, storing and using multiple items like cotton gowns and blankets, and various OR warming products while improving patient satisfaction by keeping patients warm, cozy and covered. This all-in-one warming capability makes the Bair Paws flex gown a great option for achieving normothermia-related quality measures.
3M™ Ranger™ Blood and Fluid Warming Systems (www.rangerfluidwarming.com) A complete protocol for perioperative temperature management should include both forced-air warming and the warming of infused blood and fluids to help maintain a patient’s core body temperature. Ranger blood and fluid warming systems feature highly conductive heating plates that disperse heat immediately, handling sudden changes in flow with ease. Dry heat technology disperses heat evenly, eliminating dangerous hot spots and overheating of fluids by monitoring the temperature four times every second, automatically adjusting to maintain a consistent set point. And, because the system utilizes dry heat technology rather than a water-based method, concerns regarding water in the operating room—and its potential ties to nosocomial pathogens—are eliminated. 3M is a trademark of 3M Company, used under license in Canada. SPOTON, BAIR HUGGER, BAIR PAWS and RANGER and the BAIR HUGGER, BAIR PAWS and RANGER logos are trademarks of Arizant Healthcare Inc., used under license in Canada. 1. Barie PS. Surgical site infections: epidemiology and prevention. Surg Infect (Larchmt). 2002;3[supp]:S9-S21. 2. Jeran L. American Society of PeriAnesthesia Nurses Development Panel. Clinical guideline for the prevention of unplanned perioperative hypothermia. J Perianesth. Nurs. 2001;16:305-314. 3. Tryba M, Leban J. Does active warming of severely injured trauma patients influence perioperative morbidity? Anesthesiology. 1996;85:A283.
This corporate profile was reviewed and approved by Arizant Healthcare Inc., a 3M Company.
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CADENCE PHARMACEUTICALS AT A GLANCE
C
adence Pharmaceuticals, Inc., is a biopharmaceutical company focused on acquiring, in-licensing, developing and commercializing proprietary products principally for use in the hospital setting. Cadence is committed to improving the lives of hospitalized patients while building the premier hospitalfocused pharmaceutical company in North America—a vision that has remain unchanged since the company’s inception in 2004. “Our goal is to become a leading biopharmaceutical company focused on the development and commercialization of proprietary pharmaceuticals principally for use in the hospital setting.” —Ted Schroeder, president and CEO of Cadence
Improving the Lives of Hospitalized Patients Cadence is focused on addressing significant unmet needs in the hospital setting and the potential products that can help fill those needs to the benefit of institutions and the patients they serve. In 2006, Cadence in-licensed the exclusive U.S. and Canadian rights to OFIRMEV® (acetaminophen) injection, an intravenous formulation of acetaminophen. OFIRMEV is approved for the management of mild to moderate pain, the management of moderate to severe pain with adjunctive opioid analgesics, and the reduction of fever. The FDA granted marketing approval for OFIRMEV in November 2010, and Cadence launched the product commercially in January 2011. Prior to the commercial launch of OFIRMEV in January 2011, the U.S. IV analgesic therapy market consisted of opioids (such as morphine, meperidine, hydromorphone and fentanyl) and two nonsteroidal anti-inflammatory drugs (NSAIDs). OFIRMEV is the first in the class of IV nonopioid, non-NSAID analgesics approved in the United States. When used as part of a multimodal approach to pain management in placebo-controlled clinical studies, OFIRMEV demonstrated significant pain relief, reduced the consumption of opioids and improved patient satisfaction. OFIRMEV also is the first and only IV medication indicated for the treatment of pain and fever in children aged 2 years and older. Cadence’s Hospital Sales Specialists are a team of highly experienced professionals. These field personnel have extensive hospital experience and are dedicated to educating doctors, pharmacists, nurses and other health
ADDRESS 12481 High Bluff Dr., Ste. 200 San Diego, CA 92130 Phone: (858) 436-1400 Website: www.cadencepharm.com
PRODUCT OFIRMEV® (acetaminophen) injection care professionals on effective approaches to multimodal analgesia and the appropriate use of OFIRMEV. As of March 31, 2013, an estimated 3.2-4.0 million patients have been treated with OFIRMEV, and the product was successfully placed on formulary at approximately 2,200 institutions in the United States. By bringing to market differentiated products like OFIRMEV, and establishing strong partnerships with hospitals across the nation, Cadence is striving to deliver on its mission to improve the lives of hospitalized patients.
About OFIRMEV (acetaminophen) injection OFIRMEV® (acetaminophen) injection (1000 mg/100 mL, 10 mg/mL; for intravenous use only), Cadence Pharmaceuticals’ proprietary intravenous formulation of acetaminophen, is indicated for the management of mild to moderate pain, the management of moderate to severe pain with adjunctive opioid analgesics and the reduction of fever.1 The FDA approval of OFIRMEV was based on data from clinical trials in approximately 1,020 adult and 355 pediatric patients.1 These trials included two studies evaluating the safety and effectiveness of OFIRMEV in the treatment of pain and one study evaluating OFIRMEV in the treatment of fever.1-4 The effectiveness of OFIRMEV for the treatment of acute pain and fever has not been studied in pediatric patients less than 2 years of age.
This corporate profile was reviewed and approved by Cadence Pharmaceuticals.
Important Safety Information OFIRMEV is contraindicated in patients with severe hepatic impairment, severe active liver disease, or with known hypersensitivity to acetaminophen or to any of the excipients in the formulation. Acetaminophen should be used with caution in patients with the following conditions: hepatic impairment or active hepatic disease, alcoholism, chronic malnutrition, severe hypovolemia or severe renal impairment. Do not
EMPLOYEES 210
PRESIDENT AND CEO Ted Schroeder
exceed the maximum recommended daily dose of acetaminophen. Administration of acetaminophen by any route in doses higher than recommended may result in hepatic injury, including the risk of severe hepatotoxicity and death. OFIRMEV should be administered only as a 15-minute infusion. Discontinue OFIRMEV immediately if symptoms associated with allergy or hypersensitivity occur. Do not use in patients with acetaminophen allergy. The most common adverse reactions in patients treated with OFIRMEV were nausea, vomiting, headache and insomnia in adult patients and nausea, vomiting, constipation, pruritus, agitation and atelectasis in pediatric patients. OFIRMEV is approved for use in patients ≥2 years of age. The antipyretic effects of OFIRMEV may mask fever in patients with postsurgical pain. For more information, please see the complete OFIRMEV prescribing information, available at www.OFIRMEV.com or www.cadencepharm.com.
References 1. OFIRMEV® (acetaminophen) injection prescribing information. San Diego, CA: Cadence Pharmaceuticals, Inc. 2. Sinatra RS, Jahr JS, Reynolds LW, Viscusi ER, Groudine SB, Payen-Champenois C. Efficacy and safety of single and repeated administration of 1 gram intravenous acetaminophen injection (paracetamol) for pain management after major orthopedic surgery. Anesthesiology. 2005;102:822-831. 3. Wininger SJ, Miller H, Minkowitz HS, et al. A randomized, double-blind, placebo-controlled, multicenter, repeat-dose study of two intravenous acetaminophen dosing regimens for the treatment of pain after abdominal laparoscopic surgery. Clin Ther. 2010; 32:2348-2369. 4. Kett DH, Breitmeyer JB, Royal MA. A randomized study of the efficacy and safety of intravenous acetaminophen vs. intravenous placebo for the treatment of fever. Clin Pharmacol Ther. 2011;90:32-39.
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DRÄGER G Technology for Life®
AT A GLANCE
D
räger develops innovative equipment and solutions trusted by people the world over when lives are on the line. In clinical settings, industry, mining and emergency services, Dräger products protect, support and save lives. “Technology for Life” means more than merely guaranteeing technical excellence. It means assuming responsibility for the lives of those who use our products and depend on them. Technology for Life is both our guiding principle and the central challenge that we draw on for inspiration and motivation. “We do everything we do with passion—and we do it for life.” —Stefan Dräger, Executive Board chairman
Global Leader in Medical Technology For more than 100 years, Dräger has been creating solutions that protect life, from innovative anesthesia delivery systems to professional diving technology and gas detection equipment. As a leader in medical and safety technology, Dräger employs more than 10,000 people worldwide. The company is present in more than 190 countries to effectively serve customers around the globe. The expertise of our management and employees is crucial to the growing globalization of our company. Our employees are characterized by their customer focus, entrepreneurial attitude, flexibility and global orientation. The company is headed by Stefan Dräger, the fifth generation of Dräger family members to lead the organization. Having your name on the equipment that your customers rely on makes it personal.
seamless integration of patient monitoring information enables the automated data capture that helps users focus on patients, not paperwork.
An integrated monitoring solution that makes it easier to get all the information you want It starts with an open architecture design and an ability to host multiple applications simultaneously. The widescreen format of the Infinity® Omega solution puts more of that data at your fingertips at one time. As an electronic version of the traditional patient folder, it saves you time, facilitates decision making and helps reduce the potential for medical errors. Plus, uninterrupted patient monitoring from pre-op to the postanesthesia care unit ensures the most complete patient picture possible.
Platform consistency that protects your investment and your patients Dräger’s consistency of platforms makes training more transparent, helping to minimize training costs and reduce errors. In fact, the use of a consistent user interface across Dräger anesthesia product lines can significantly reduce the time needed to learn all the platforms required to support various care settings, ranging from the operating room to magnetic resonance imaging
An integrated anesthesia solution that simplifies operation so you can focus on your patients
GLOBAL HEADQUARTERS Drägerwerk AG & Co. KGaA Moislinger Allee 53-55 23558 Lübeck, Germany Phone: +49-451-882-0 Fax: +49-451-882-2080 Email: info@draeger.com
NORTH AMERICAN HEADQUARTERS Draeger Medical, Inc. 3135 Quarry Rd. Telford, PA 18969 Phone: (800) 4-DRAGER (437-2437) Fax: (215) 723-5935 Email: info.usa@draeger.com Website: www.draeger.com
PRODUCTS Anesthesia workstations, monitoring systems, enterprise solutions, information technologies, ventilation therapy, home mechanical ventilation, warming therapy, architectural systems, accessories, surgical lighting and video systems, DrägerService®, education and training
EMPLOYEES Approximately 10,000 worldwide
PRESIDENT AND CEO Stefan Dräger
and mobile environments. More importantly, it enables a familiarity that allows you to react intuitively, confidently and efficiently. To learn more about Dräger anesthesia workstation solutions, contact your local anesthesia sales representative or visit us on the web at www.draeger.com, or at one of the many trade shows we attend during the year.
By incorporating a single, intuitive user interface across workstations, Dräger enables anesthesia professionals to efficiently transition from one care area and case type to the next. Truly digital anesthesia delivery and
Infinity Omega-S brings together patient data from diverse sources—such as vital signs, lab data, DICOM images (x-ray, MRI, CT, US) and access to the patient’s electronic patient record (EPR). The Infinity Omega-S Solution is part of Dräger’s comprehensive anesthesia workplace.
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Anesthesiology News • August 2013
This corporate profile was reviewed and approved by Dräger.
Dräger Anesthesia.
Rated #1 for system performance and system reliability.*
Providing clinicians the performance and reliability to meet today’s OR challenges For more than a century, Dräger has been providing anesthesia technology clinicians can count on. Our experience has led to innovations such as piston ventilation technology, which allows clinicians to deliver highly accurate therapies for improved patient outcomes. From anesthesia machines to anesthesia monitors to anesthesia information management systems, no other company is more focused on anesthesia care than Dräger.
VISIT WWW.DRAEGER.COM/PERFORM TO LEARN ABOUT OUR ANESTHESIA WORKSTATIONS *MD Buyline User Ratings, Q1 2013
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EDWARDS W S LIFESCIENCES SC C S AT A GLANCE
A choice of hemodynamic monitoring options to meet the most challenging clinical needs.
E
dwards Lifesciences’ hemodynamic monitoring and management systems enable tailored hemodynamic optimization. The systems provide clarity into patient status, helping clinicians to make more informed and rapid decisions to achieve hemodynamic balance. Edwards’ extensive line of hemodynamic management sensors, catheters and monitoring tools support clinicians’ needs in the operating room (OR) and intensive care unit (ICU). Hemodynamic instability may increase with more complicated or invasive procedures and with the presence of various comorbidities. As a result, clinicians’ hemodynamic monitoring needs and preferences may vary with the complexity of each procedure and patient. Edwards provides a range of monitoring options that can be used in Perioperative Goal-Directed Therapy (PGDT) protocols to optimize fluids in moderate to high-risk surgery patients. Edwards’ objective is to provide the clarity for more informed decisions with a variety of monitoring tools that match a patient’s needs. The ccNexfin sensor is a noninvasive finger cuff monitoring method that provides real-time hemodynamic information, including blood pressure and certain flowbased parameters such cardiac output, stroke volume and stroke volume variation. The FloTrac sensor is the first minimally invasive hemodynamic monitoring device that connects to any existing arterial line. The FloTrac sensor continuously calculates key flow parameters such as cardiac output, stroke volume and stroke volume variation. The
ADDRESS
PreSep oximetry catheter continuously measures a patient’s central venous oxygen saturation, providing an earlier and more global view of tissue oxygenation and consumption. The Swan-Ganz pulmonary artery catheter with advanced monitoring capability provides a single, continuous monitoring solution for the most complex patients. The Edwards Swan-Ganz catheter remains the leading pulmonary artery catheter for surgical, critical care and trauma patients worldwide. The EV1000 clinical platform presents the physiologic and hemodynamic status of the patient in an intuitive and meaningful way. Designed to work with the FloTrac sensor and PreSep oximetry catheter, the platform offers the scalability and adaptability for both the OR and ICU. Edwards TruWave pressure transducer can be combined with the VAMP (Venous Arterial blood Management Protection) closed-loop blood sampling system to protect both patients and clinicians from the risk for infection. Edwards offers an extensive line of education and support tools to facilitate the integration of advanced hemodynamic monitoring in all acute care settings. www.Edwards.com/CCeducation features perioperative patient simulations, simulated case studies, product animations and more. Or visit youtube.com/ECCE4you for OR- and ICU-specific playlists. Edwards recognizes that assessing a patient’s hemodynamic and oxygenation status and minimizing the
One Edwards Way Irvine, CA 92614 Phone: (800) 424-3278; (949) 250-2500 Email: CriticalCare@Edwards.com Website: www.Edwards.com/CriticalCare Or www.Edwards.com/CCeducation
PRODUCTS Hemodynamic monitoring systems including the ccNexfin sensor; FloTrac sensor; PreSep oximetry catheter; Swan-Ganz pulmonary artery catheter; TruWave pressure transducer; VAMP (Venous Arterial blood Management Protection) system; and EV1000 clinical platform
risk for infection are fundamental requirements for moderate and high-risk surgery and for treating critically ill patients. Edwards will continue to leverage its more than 40 years of experience and leadership in this area to help clinicians advance patient care. 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, Edwards Lifesciences, the stylized E logo, ccNexfin, EV1000, FloTrac, Nexfin, PreSep, Swan-Ganz, TruWave and VAMP are trademarks of Edwards Lifesciences Corporation.
The EV1000 clinical platform provides a variety of informative screens from which to choose to provide immediate insight and guide your therapeutic interventions. The platform also allows you to select the parameters most significant for your monitoring requirements, enabling you to make more informed decisions and determine the best course of action.
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Anesthesiology News • August 2013
This corporate profile was reviewed and approved by Edwards Lifesciences.
Clarity through advanced hemodynamic monitoring for your moderate to high-risk surgery ccNexďŹ n System
FloTrac Sensor
Swan-Ganz Advanced Tech
(Noninvasive)
(Minimally-Invasive)
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Visit edwards.com/PGDT to learn more about our valuable hemodynamic optimization tools and resources.
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. %DWARDS ,IFESCIENCES DEVICES PLACED ON THE %UROPEAN MARKET MEETING THE ESSENTIAL REQUIREMENTS REFERRED TO IN !RTICLE OF THE -EDICAL $EVICE $IRECTIVE %%# BEAR THE #% MARKING OF CONFORMITY %DWARDS %DWARDS ,IFESCIENCES THE STYLIZED % LOGO CC.EXlN &LO4RAC .EXlN AND 3WAN 'ANZ ARE TRADEMARKS OF %DWARDS ,IFESCIENCES #ORPORATION ÂĽ %DWARDS ,IFESCIENCES #ORPORATION !LL RIGHTS RESERVED !2
Edwards Lifesciences 53! | 3WITZERLAND | Japan | China | "RAZIL | Australia | )NDIA EDWARDS COM
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MAQUET QU MEDICAL C SSYSTEMS S S US USA The Gold Standard
M
AQUET Medical Systems USA is a market-leading medical company in the United States whose mission is to improve patient outcomes and quality of life through advanced technology. MAQUET designs, develops and distributes innovative products and therapeutic solutions, and provides infrastructure capabilities for the hybrid operating room (OR), general OR, intensive care unit (ICU) and patient transport within acute care hospitals. MAQUET has a long history of innovation in anesthesia, beginning with the introduction of its first anesthesia machine in 1981. Since then, the company has delivered more than 6,500 units to hospitals worldwide. It also has set market standards with its high-performance SERVO ventilation platform for more than 40 years. The company has a deep understanding of mechanical ventilation and the challenges facing anesthesiologists today. Not only are patient demographics constantly shifting, but surgical procedures are becoming more complex on a daily basis, necessitating advanced technology to ensure optimal patient care. MAQUET invests significantly in research and development to meet the changing needs of hospitals and anesthesiologists and ensure that it can provide anesthesia products that offer high-performance ventilation and support capabilities. MAQUET’s flagship anesthesia product, the FLOW-i Anesthesia Delivery System with high-performance SERVO ventilation, offers true ICU ventilator performance and effective anesthesia delivery from the same unit.
FLOW-i Anesthesia Delivery System With High-Performance SERVO Ventilation MAQUET’s FLOW-i Anesthesia Delivery System seamlessly combines high-performance SERVO ventilation with precise anesthesia delivery to help meet the needs of all patients. These include the most challenging cases, such as obese patients with high abdominal and
AT A GLANCE thoracic pressures, older patients suffering from multiple medical conditions, the critically ill and the smallest neonates. FLOW-i reacts quickly to changing parameters as the low internal system volume enables rapid changes in gas concentration when needed, and facilitates fast wash-in and wash-out of the anesthetic agent. This process helps to minimize waste and unnecessary use of the agent through precise delivery technology.
High-Performance Ventilation Features • Set tidal volume is accurately delivered even under high abdominal and thoracic pressures, helping to avoid hypoventilation. • Fast rise time and high flow rates adapt to varying inspiratory demand in the presence of increasing airway pressure. • Sensitive triggering improves synchrony in pediatric patients and those with decreased respiratory drive. • Consistent and accurate PEEP levels are maintained. • Controlled pressure drop during expiration decreases expiratory resistance and work of breathing, in addition to minimizing auto-PEEP at higher respiratory rates.
Advanced Design and Technology The FLOW-i system’s ergonomically designed, fully electronic platform and touch-screen interface are easy to use and upgrade for enhanced workflow today and in the future. The open architecture allows hospitals to add the patient monitor and data management system of their choice and easily integrate future software and hardware advances into the system—increasing cost efficiency by avoiding the need for costly equipment replacement or upgrades. In addition, clinician ease of use and comfort are engineered into every FLOW-i machine with its height adjustability, movable arms and integrated table light.
U.S. HEADQUARTERS MAQUET Medical Systems USA 45 Barbour Pond Dr. Wayne, NJ 07470 Phone: (888) 627-8383 Website: www.maquetusa.com
PRODUCTS Intensive care ventilators and anesthesia machines, suite of cardiovascular products (for intra-aortic balloon counterpulsation, cardiac assist, coronary artery bypass surgery, aortic and peripheral vascular surgery, and extracorporeal circulation), flexible room design for OR and ICU, OR tables, lights and ceiling supply units and OR integration
EMPLOYEES 6,000 MAQUET employees in 50 international sales and service organizations, as well as a network of more than 280 sales representatives
PRESIDENT AND CEO Raoul Quintero
Innovative Volume Reflector™ Re-Breathing Technology The FLOW-i system features the innovative Volume Reflector technology to ensure that the breathing circuit will never be empty and ventilation will remain uninterrupted regardless of surgical constraints, changing conditions or patient position. The re-breathing technology consists of a rigid reservoir to minimize internal system volume for high ventilation performance. It replaces both the traditional bag-in-bottle (bellows) and the piston, allowing the partial re-administration of rebreathed gas to the patient via the circle system. Oxygen-driven by design, the Volume Reflector helps to minimize the risk for delivering a potentially dangerous hypoxic mixture in the presence of leaks during lowflow anesthesia. FLOW-i also contains anesthetic agent injection vaporizers that are fully electronic, are lightweight and can be refilled while slotted in the machine, even when one is still in use.
Learn More To learn more about the MAQUET FLOW-i Anesthesia Delivery System, please visit www.maquetusa.com.
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Anesthesiology News • August 2013
This corporate profile was reviewed and approved by MAQUET Medical Systems USA.
-!1 #OPYRIGHT¬-!15%4¬-E EDICAL¬3YSTEMS¬53!¬OR¬ITS¬AFFILIATES ¬s¬ #!54)/. ¬&EDERAL 53 ¬LAW¬RESTRICTS¬THIS¬DEVICE¬TO¬SALE¬BY¬OR¬O E¬ N¬THE¬ORDER¬OF¬A PHYSICIAN ¬2EFER¬TO¬ )NSTRUCTIONS¬FOR¬5SE¬FOR¬CURRENT¬INDICATIONS ¬WARNINGS ¬CONTRAI TRA NDICATIONS ¬AND¬PRE ECAUTIONS
FLOW-i A REVOLUTION IN ANESTHESIA DELIVERY TECHNOLOGY
Anesthesia Delivery And The True Cost Of Ownership )N¬TODAY S¬EVER CHANGING¬HEALTHCARE¬REIMBURSEMENT¬ENVIRONMENT ¬HOSPITALS¬AND¬OUTPATIENT¬ SURGERY¬CENTERS¬DEMAND¬SUPERIOR¬TECHNOLOGY¬WITH¬LONG TERM¬COST¬CONTAINMENT ¬0ARTNER¬WITH¬ -!15%4¬AND¬DISCOVER¬THE¬TRUE¬COST¬OF¬YOUR¬CURRENT¬ANESTHESIA¬PLATFORM ¬COMPARED¬TO¬THE¬ REVOLUTIONARY¬&,/7 I¬SYSTEM ¬AND¬MAKE¬THE¬RIGHT¬CHOICE¬FOR¬YOUR¬PATIENTS¬AND¬YOUR¬BUSINESS Call us at 888-627-8383 or email marketing@maquet.com to trial the revolution in anesthesia delivery technology — FLOW-i.
Learn More maquetflowi.com
www.maquetusa.com
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MASIMO AT A GLANCE
Taking Noninvasive Monitoring to New Sites and Applications
F
or more than 20 years, Masimo has focused on a singular mission—helping clinicians improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications.
Continuing to SET the Benchmark for Oxygenation Monitoring During Challenging Conditions Masimo SET® (Signal Extraction Technology®) is the proven leader in pulse oximetry, demonstrated by both clinical research and the real-world success of customers and OEM partners. More than 100 independent and objective studies have shown that Masimo SET® outperforms all other pulse oximetry technologies, providing clinicians with unmatched sensitivity and specificity to make critical patient care decisions—even under the challenging conditions of motion and low perfusion.1 Most importantly, only Masimo SET® pulse oximetry has been shown to improve patient outcomes by helping clinicians reduce retinopathy of prematurity2; screen newborns for critical congenital heart disease (CCHD)3,4; reduce ventilator weaning time5; and save lives while reducing rapid response activations and ICU transfers on the general floor.6
rainbow® Technology Helps Clinicians Protect Patients From Hidden Dangers Throughout the Hospital rainbow® technology comprises a suite of continuous, noninvasive measurements designed to help clinicians with some of the most common, costly and critical decisions made in health care today. The rainbow® suite includes: • Total hemoglobin (SpHb®) • Methemoglobin (SpMet®) • Carboxyhemoglobin (SpCO®) • Oxygen content (SpOC™) • Acoustic respiration rate (RRa™) • All Masimo SET® measurements
Helping Clinicians Reduce Blood Transfusions and Detect Internal Bleeding
hospitals,7 a growing body of clinical evidence suggests that overuse of RBC transfusion increases both patient risk and the cost of care.8-11 Masimo’s continuous, noninvasive SpHb monitoring helps clinicians reduce RBC transfusions in low blood loss surgery12 and high blood loss surgery.13 In addition, by measuring continuously, SpHb helps clinicians detect real-time drops in hemoglobin that may be indicative of bleeding. Identification of low or falling hemoglobin levels could allow interventions that may prevent unnecessary disability or death.
Protecting More Patients by Monitoring Every Breath The Anesthesia Patient Safety Foundation and the Joint Commission recommend continuous oxygenation and ventilation monitoring in all patients receiving opioid-based pain medications.14 However, current methods for respiration rate monitoring are limited by patient tolerance. While we offer the best-in-class capnography solution, we believe rainbow Acoustic Monitoring™ with Acoustic Respiration Rate (RRa) is better suited for postsurgical monitoring and conscious sedation due to its demonstrated ability to detect respiratory pause.15
References 1. Shah N, Ragaswamy HB, Govindugari K, Estanol L. J Clin Anesth. 2012:24:385-391. 2. Castillo A, Deulofeut R, Critz A, Sola A. Prevention of retinopathy of prematurity in preterm infants through changes in clinical practice and SpO2 technology. Acta Paediatr. 2011;100:188-192. 3. de-Wahl Granelli A, Wennergren M, Sandberg K, et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009;338: a3037. ®
features complete rainbow® measurements, intuitive touchscreen display, standard wireless radio, and full-screen trending.
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Anesthesiology News • August 2013
4. Ewer AK, Lancet. 2011;378:785-794.
PRODUCTS Masimo SET® pulse oximetry and sensors; rainbow® Pulse CO-Oximetry and sensors; rainbow Acoustic Monitoring™; SedLine® brain function monitoring; Phasein™ capnography and gas monitoring; Patient SafetyNet™ general floor monitoring
MISSION STATEMENT Improving patient outcomes and reducing cost of care by taking noninvasive monitoring to new sites and applications
EMPLOYEES 3,000
Joe Kiani
In August 2012, the Joint Commission Sentinel Event Alert on the safe use of opioids in hospitals recommended implementation of better dosing along with continuous oxygenation and ventilation monitoring (instead of spot checks) in postsurgical patients.16 Our Patient SafetyNet system combines Masimo SET® pulse oximetry, breakthrough rainbow® measurements and remote patient monitoring with wireless clinician alerts. After implementing Masimo SET® and Patient SafetyNet in a postsurgical floor where only intermittent spot checking was used before, Dartmouth-Hitchcock Medical Center reduced rapid response activations by 65% and ICU transfers by 48%6 and saved $1.48 million annually. In addition, no patients suffered irreversible, severe brain damage or died as a result of respiratory depression from opioids over a five-year period.17
*The use of the trademarks PATIENT SAFETYNET and PSN is under license from University Health System Consortium.
40 Parker Irvine, CA 92618 Phone: (949) 297-7000 Website: www.masimo.com
FOUNDER AND CEO
Helping Improve Outcomes on the General Floor With Patient SafetyNet™*
Although red blood cell (RBC) transfusion is one of the most frequent procedures performed in U.S.
ADDRESS
5. Durbin CG Jr, Rostow SK. More reliable oximetry reduces the frequency of arterial blood gas analyses and hastens oxygen weaning after cardiac surgery: a prospective, randomized trial of the clinical impact of a new technology. Crit Care Med. 2002;30:1735-1740. 6. Taenzer AH, Pyke JB, McGrath SP, Blike GT. Impact of pulse oximetry surveillance on rescue events and intensive care unit transfers: a before-and-after concurrence study. Anesthesiology. 2010;112:282-287. 7. AHRQ. Inpatient Sample. 1997-2007. 8. Marik PE, Corwin HL. Efficacy of red blood cell transfusion in the critically ill: a systematic review of the literature. Crit Care Med. 2008;36:2667-2674. 9. Carson JL, Carless PA, Hebert PC. Transfusion thresholds and other strategies for guiding allogeneic red blood cell transfusion. Cochrane Database Syst Rev. 2012;4:CD002042. 10. Shander A, Hofmann A, Ozawa S, Theusinger OM, Gombotz H, Spahn DR. Activity-based costs of blood transfusions in surgical patients at four hospitals. Transfusion. 2010;50:753-765. 11. Murphy GJ, Reeves BC, Rogers CA, Rizvi SI, et al. Increased mortality, postoperative morbidity, and cost after red blood cell transfusion in patients having cardiac surgery. Circulation. 2007;116:2544-2552. 12. Ehrenfeld JM et al. ASA. 2010. LB05 (abstract). 13. Awada WFN, Maher F. Proceeding of the Society for Technology in Anesthesia Annual Meeting, 2013: p 51. 14. Stoelting RK et al. APSF Newsletter. 2011. www.apsf.org. 15. Ramsay MA, Usman M, Lagow E, et al. The accuracy, precision and reliability of measuring ventilatory rate and detecting ventilatory pause by Rainbow Acoustic Monitoring and Capnometry. Anesth Analg. 2013 April 30. [Epub ahead of print] 16. The Joint Commission. Sentinel Event Alert. 2012:49. 17. Taenzer AH, et al. APSF Newsletter. 2012;27:1.
This corporate profile was reviewed and approved by Masimo.
Breakthrough Measurements. Radical Monitor.
Radical-7
®
Once again raising the technology bar, the Radical-7 leverages Masimo’s breakthrough noninvasive measurements with a radical departure from traditional monitoring for breakthrough functionality designed to automate the process of care and enable clinicians to instantly adapt to changing monitoring needs in individual patients and care areas. > Breakthrough noninvasive measurements: · Total Hemoglobin (SpHb®) · Pleth Variability Index (PVI®) · Oxygen Content (SpOC™) · Acoustic Respiration Rate (RRa™) ® · Methemoglobin (SpMet ) · Carboxyhemoglobin (SpCO®) > Instantly adaptable functionality > Intuitive touchscreen operation > Integrated wireless connectivity > Easy customization
For more information, visit www.masimo.com/rainbow/radical7.htm 800-257-3810 © 2013 Masimo Corporation. All rights reserved.
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MCMAHON PUBLISHING
M
cMahon Publishing was founded in 1972 by Raymond E. McMahon and has grown to become one of the nationâ&#x20AC;&#x2122;s largest family-owned medical publishers. McMahon publishes a broad array of medical newsmagazines in various specialties, including anesthesiology, gastroenterology, general surgery, hospital and specialty pharmacy, infectious diseases, pain medicine, rheumatology and oncology. The combined circulation of McMahon publications is approximately 300,000 doctors and pharmacists. McMahon newsmagazines are accompanied by a full line of digital media, including websites, e-newsletters, digital editions, podcasts, Twitter feeds, Facebook pages and other digital communication to readers. Foremost among McMahon publications is Anesthesiology News. Now in its 39th year, Anesthesiology News has been the best-read publication in the field for the past 16 years (according to Kantar Media). Nearly 93% of the 46,546 U.S.-based anesthesiologists read this publication each month.
AT A GLANCE ADDRESS 545 W. 45th St., 8th Fl. New York, NY 10036 Phone: (212) 957-5300 Fax: (212) 957-7230 Websites: www.mcmahonmed.com www.anesthesiologynews.com @anesthesianews anesthesiologynews
PRODUCTS Medical newsmagazines, custom medical publications, educational reviews, special editions, podcasts, pocket guides and more.
EMPLOYEES 60
PUBLISHER, CEO AND MANAGING PARTNER Raymond E. McMahon
GENERAL MANAGER, PARTNER Matthew McMahon
ANESTHESIOLOGY NEWS Managing Editor Adam Marcus Senior Group Publication Director Richard Tuorto Manager, Publication Sales Angela Labrozzi Junior Sales Associate, Classifieds Alina Dasgupta Production Manager Martin Barbieri Art Director Blake Dennis
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This corporate profile was reviewed and approved by McMahon Publishing.
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Corporate Profiles
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PACIRA C PHARMACEUTICALS, C U C S, INC. C
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acira Pharmaceuticals, Inc. is an emerging specialty pharmaceutical company focused on the clinical and commercial development of new products to address the needs of acute care practitioners and their patients. Pacira is driven by a dynamic workforce committed to optimizing patient care and satisfaction in the acute care setting, with a special focus on improving outcomes in postsurgical pain management.
A Proprietary Drug Delivery Platform The cornerstone of the Pacira product portfolio is DepoFoam®, a proprietary drug delivery platform designed to extend a medication’s duration of action without altering its molecular structure. The DepoFoam carrier matrix is made up of multivesicular liposomes that encapsulate a drug. Each chamber is separated by lipid membranes that naturally erode to release the drug over a desired period of time.
EXPAREL as the foundation of an opioid-sparing multimodal postsurgical pain management regimen. Recently published national and regional retrospective analyses2,3 of more than 400,000 postsurgical patients receiving opioids concluded that patients who experienced opioid-related adverse events had both longer lengths of hospital stay and higher hospitalization costs. The company’s efforts are buoyed by a groundswell movement led by governmental and independent health care organizations to mitigate potentially fatal side effects related to the use of opioids by recommending a shift toward opioid-sparing pain regimens, especially in high-risk postsurgical patients.
Clinical Utility Across a Broad Range of Potential Applications EXPAREL has broad applications across multiple surgical specialties, as well as in the anesthesiology arena. Pacira recently presented data supporting the administration of EXPAREL via infiltration into the transversus abdominis plane to produce up to 72 hours of postsurgical analgesia. The company is also advancing its Phase 3 nerve block program studying the safety and efficacy of EXPAREL administered as a femoral or intercostal nerve block.
The Pacira Advantage
A First of Its Kind Single-Dose Local Analgesic In 2012, Pacira successfully launched EXPAREL® (bupivacaine liposome injectable suspension), the first and only DepoFoam-based local analgesic. Indicated for administration into the surgical site to produce postsurgical analgesia, a single dose of EXPAREL provides nonopioid pain control with reduced opioid requirements for up to 72 hours* without the need for catheters or pumps.1
Shifting the Postsurgical Pain Management Paradigm The launch of EXPAREL is bolstered by a robust Phase 4 clinical program, which builds a compelling case for
Discovery, innovation and proprietary expertise are the hallmarks of the Pacira competitive advantage. The company not only holds the exclusive rights and expertise to DepoFoam, but owns the unique distinction of being the only company in the world with the ability to manufacture DepoFoam-based products, such as EXPAREL, on a large commercial scale. With steadily increasing demand and a growing list of potential clinical applications, Pacira and EXPAREL are poised to become vital fixtures in the postsurgical pain management arena. For more information about Pacira Pharmaceuticals Inc., visit www.pacira.com.
Important Safety Information for EXPAREL EXPAREL is contraindicated in obstetrical paracervical block anesthesia. EXPAREL has not been studied for use in patients younger than 18 years of age. Non-bupivacaine-based local anesthetics, including lidocaine, may cause an immediate release of bupivacaine from EXPAREL if
This corporate profile was reviewed and approved by Pacira Pharmaceuticals, Inc.
AT A GLANCE ADDRESS 5 Sylvan Way Parsippany, NJ 07054 Phone: (973) 254-3560 Fax: (973) 267-0060 Website: www.Pacira.com For more information on EXPAREL, visit www.EXPAREL.com For medical inquiries related to EXPAREL, contact Medical Information at medinfo@pacira.com or 1-855-RX-EXPAREL (1-855-793-9727)
administered together locally. The administration of EXPAREL may follow the administration of lidocaine after a delay of 20 minutes or more. Other formulations of bupivacaine should not be administered within 96 hours following administration of EXPAREL. Monitoring of cardiovascular and neurological status, as well as vital signs, should occur during and after injection of EXPAREL as with other local anesthetic products. Because amide-type local anesthetics, such as bupivacaine, are metabolized by the liver, EXPAREL should be used cautiously in patients with hepatic disease. Patients with severe hepatic disease, because of their inability to metabolize local anesthetics normally, are at a greater risk for developing toxic plasma concentrations. In clinical trials, the most common adverse reactions (incidence ≥10%) following the administration of EXPAREL were nausea, constipation and vomiting. *Pivotal studies have demonstrated the safety and efficacy of EXPAREL in patients undergoing bunionectomy and hemorrhoidectomy procedures. 1. Gorfine SR, Onel E, Patou G, Krivokapic ZV. Dis Colon Rectum. 2011;54:1552-1559. 2. Oderda GM, Gan TJ, Johnson BH, Robinson SB. J Pain Palliat Care Pharmacother. 2013;27:62-70. 3. Kessler ER, Shah M, Gruschkus SK, Raju A. Pharmacotherapy. 2013;33:383-391.
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2013-2014
Corporate Profiles
ANNUAL
PLEXUS INFORMATION SYSTEMS, INC. AT A GLANCE
A Plexus Management Group Subsidiary
P
lexus Management Group, Inc. (“Plexus”) is a practice management organization dedicated to serving anesthesia and pain management providers. Plexus provides effective solutions to maximize practice operations and return for each of its clients. Among the services Plexus offers are: • Payer contract negotiation • Strategic planning and budgeting • Hospital/Ambulatory Surgery Center negotiations • Billing and collections • Anesthesia department consulting • Human resources and benefits management • Credentialing • Quality assurance/risk management services • Compliance support • Information technology assessment • Captive insurance development • Joint Commission preparation • Certified coding • OR management In 2009, after researching anesthesia information management systems (AIMS) for their clients, the executive team at Plexus agreed the best solution was to develop their own AIMS. Albert Woo, MD, president and founder of Plexus Information Systems, Inc. (“Plexus IS”) designed the first AIMS for the Apple iPad iOS platform. Dr. Woo is a board-certified anesthesiologist with vast experience in health care information technologies (IT). He began studying IT during his undergraduate studies in molecular cell biology at the University of California, Berkeley, and worked for several software companies before and during his medical studies at New York Medical College. Dr. Woo’s clinical and software development background is unique in the industry and proved the ideal combination to design one of the most innovative AIMS on the market today.
Anesthesia Touch™—The Ultimate AIMS The Plexus IS intraoperative anesthesia record, Anesthesia Touch™, offers the most functionality and adaptability of any AIMS and uses a cloud-based solution for capturing, managing and storing patient information. Anesthesia Touch is a full-featured AIMS that operates natively on the iPad iOS platform, as well as traditional desktop workstations. Anesthesia Touch gives anesthesia providers the power to manage information electronically from single providers to the largest integrated delivery networks on one simple interface from multiple platforms and locations. Plexus IS makes use of patient registration, operating room scheduling, lab and pharmacy systems integration to achieve unparalleled clinical decision support and reporting. Plexus IS offers complete client support and maintenance, which can significantly decrease costs for health care facilities.
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Plexus IS understands that each individual anesthesia provider has preferences in his or her own practice. Anesthesia Touch provides custom templates that adapt to the complexity of medical procedures and offer the users efficient means for record keeping. In addition to using automated documentation of physiologic and machine data, Anesthesia Touch provides intelligent clinical decision support such as allergy alerts, antibiotic re-dosing and best-practice compliance reminders. Anesthesia Touch attained a “Completed EHR [electronic health record] Certification for Complete EHR Ambulatory” by the Drummond Group in 2012; it therefore will qualify anesthesia groups under Meaningful Use.
PLEXUS INFORMATION SYSTEMS CORPORATION A privately held company providing the most comprehensive AIMS on the market today that operates on the Apple iPad iOS platform. PRODUCT Anesthesia Touch™ gives anesthesia providers the power to manage information electronically in the perioperative environment on one simple interface from multiple locations. FOUNDER AND PRESIDENT Albert Woo, MD
Quality Reporting The Plexus IS reporting engine also allows departments and facilities to harvest valuable information for analysis. Anesthesia Touch has extensive quality data-capture features built into the system. Plexus IS can help practices design their own data-capture systems in addition to helping them participate in national quality databases such as the Anesthesia Quality Institute and the Society for Ambulatory Anesthesia’s Clinical Outcome Registry. This type of quality reporting can be used to help improve clinical practice as well as benchmarking performance.
Meaningful Use Plexus IS has incorporated all the criteria defined by CMS and fit them into an AIMS. Anesthesia providers can now take advantage of the interoperability encouraged by Meaningful Use in helping improve patient care and decreasing health care costs.
Plexus IS Innovations • 1st AIMS on the iPad iOS Platform • 1st AIMS to obtain ONC-ATCB Complete Ambulatory EHR Certification • 1st AIMS to obtain Vital Signs from the iPad Platform • 1st AIMS to feature Simultaneous Charting Access
CONTACT INFORMATION Phone: (800) 247-5013 Email: info@plexusis.com Website: www.plexusis.com LinkedIn: company/ plexus-information-systems PARENT COMPANY Plexus Management Group, Inc. Bob McIvor, President Dan Reale, Executive Vice President Phone: (781) 407-7771 Email: info@plexusmg.com Website: www.plexusmg.com
Health care is about providing quality care. Yet, for many health care professionals, the responsibilities of running a profitable business get in the way of this allimportant mission. At Plexus, the goal is to become your business partner, providing effective, lasting solutions to your most complex business issues. Plexus offers consulting and management services to physician practices, hospitals and medical groups. Plexus’ experienced business and clinical management teams ensure that business-related functions run at maximum efficiency.
Solutions for Busy Anesthesiologists We Don’t Practice Management. We Manage PracticesSM Plexus is one of the largest private managers of anesthesia services (more than 600 anesthesia professionals under management) with anesthesia clients throughout the United States. Plexus top management has more than 175 years combined health care expertise with more than 100 years of direct anesthesia management.
Every challenge is different. Naturally, so are the solutions. Plexus will work with you to find those that meet your specific financial, strategic and/or operational needs. In everything Plexus does, risk management and patient safety are of the utmost importance—evidenced in groundbreaking offerings like the captive insurance programs developed for a large client. Similarly, the development of Plexus Information Systems sets Plexus apart as a leader in anesthesia practice management.
This corporate profile was reviewed and approved by Plexus Information Systems, Inc.
THE ULTIMATE ANESTHESIA INFORMATION MANAGEMENT SYSTEM Discover the Power of Anesthesia TouchTM Plexus Information Systems, Inc. (Plexus IS), a subsidiary of Plexus Management Group, Inc., presents Anesthesia Touch™, a functionally rich AIMS that offers the most adaptability and scalability in the industry. Anesthesia Touch is the only AIMS solution to offer direct integration with all EMRs in the U.S.A. Anesthesia Touch gives anesthesia providers the power to manage information electronically from single providers to the largest IDNs on one simple interface from multiple platforms and locations.
Apple iOS and Windows Touchscreen
Real-time Decision Support
Comprehensive Medication Safety System with Integrated Single Login
800.247.5013
Disease Comorbidity Capture
Operates Natively on iPad
Cloud-based Solution
Full Discrete Data Interface
AQI and SCOR Preferred Vendor
OR Efficiency and Utilization
Automated Data Capture
Pharmacy Cost and Usage
Full EHR Meaningful Use Certified
Simultaneous Record Access
info@plexusis.com
www.plexusis.com
2013-2014
Corporate Profiles
ANNUAL
SSPACELABS C S HEALTHCARE C
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pacelabs 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, in Snoqualmie, Wash., is where we develop and manufacture 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 some exciting new additions coming in the near future. 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 customers’ 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. ARKON™ is our “evolutionary” new 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 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 is 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.
Spacelabs Healthcare is dedicated to developing and supporting those tools.
Spacelabs Healthcare Collaborates With Clinicians To Provide Clinically Relevant Products 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 service, service, service.
Excellence in Customer Service and Support
AT A GLANCE ADDRESS 35301 SE Center St. Snoqualmie, WA 98065 Phone: (425) 396-3300 Website: www.spacelabshealthcare.com Email: marketing@spacelabs.com
PRESIDENT AND CEO Nicholas Ong
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.
At Spacelabs Healthcare, excellence in customer service and support are not just words; they are values, embraced by all our employees, that 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 “Best for Overall Service Performance among Industry Peers” in 2011 for the second consecutive year, and three of the last six years. We work cooperatively to develop long-term relationships with our suppliers, our distribution partners and our customers to provide the products, tools and services you need. Spacelabs is a focused, agile organization that is here to serve health care professionals worldwide. Our goal is to provide our customers more time to care. Customer loyalty is our reward.
“The Spacelabs Advantage” For more than 50 years, health care professionals have experienced the company’s proven commitment to connecting innovation with care; stability for a strong future; collaboration with clinical and technological partners; effective implementation of real-world solutions; and service wherever, whenever and however it’s needed. The most important factor in patient care is a knowledgeable medical professional with the right tools.
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This corporate profile was reviewed and approved by Spacelabs Healthcare.
ASA Booth #1326
2013-2014
Corporate Profiles
ANNUAL
TEAMHEALTH ANESTHESIA S S
T
eamHealth Anesthesia is a nationally recognized provider of comprehensive anesthesia, pain management and administrative services for hospitals, surgery centers and pain management clinics. Our proven anesthesia service platform has been specifically designed to maximize operating room (OR) performance while increasing patient and surgeon satisfaction. With extensive experience as anesthesia providers, business managers and hospital/medical staff leaders, our leadership team is unsurpassed. After more than a decade of experience in dozens of hospitals nationwide, we have helped a broad range of health care facilities improve the performance of their anesthesia departments. Whether it’s augmenting an existing anesthesia group or forming a new one, TeamHealth Anesthesia provides customized solutions and first-rate specialists. In fact, we are anesthesia industry leaders in: • • • • • • • •
Surgeon satisfaction Quality metrics measurement and reporting Patient safety Recruitment and retention of anesthesiologists and certified registered nurse anesthetists (CRNAs) OR efficiency High-throughput surgery environments Group management and leadership Billing, collections, credentialing
Your Career Will Thrive With TeamHealth Anesthesia Founded by anesthesiologists, TeamHealth Anesthesia uniquely understands the needs and expectations of anesthesiologists and CRNAs. Our solid reputation in the provider community allows us to partner with the best anesthesia clinicians in the market, creating stable, top-notch groups for our hospital and surgeon partners. To continue our success, we need leading clinicians like you to be part of our team.
medical centers and teaching facilities in urban areas. With a wide variety of practice environments and case mixes, as well as varying anesthesia delivery models— from direct anesthesia care to anesthesia care teams— you’ll find opportunities to: • Nurture your professional interests while advancing your career • Receive a highly competitive salary along with benefits and performance incentives • Choose from coast-to-coast nationwide practice opportunities • Practice medicine without the daily burdens of managing a practice • Focus on what matters most to you: patient care Best of all, when you’re part of the “team,” we provide unparalleled resources that will help you be one of the best anesthesia professionals in the nation. Through timely risk management and our leadership skills education programs like LEAD™, the TeamHealth Leadership Development Institute™ and others, you will discover that we care as much about your career and quality of life as you do.
Anesthesia Care Team Anesthesia programs nationwide are moving from the physician-only anesthesia service delivery models to mixed care team models that are comprised of physicians and CRNAs. TeamHealth Anesthesia has extensive experience in the anesthesia care team (ACT) model and has performed multiple successful transitions from physician-only models to ACT models. Our experience has shown us that the benefits of the ACT model include improved practice efficiencies, increased revenue and profits, standardization of care, flexibility, and increased patient and surgeon satisfaction. Always sensitive to the needs of surgeons and the hospitals we serve, TeamHealth Anesthesia implements the following transition activities with minimal disruption to the existing anesthesia program:
Coast-to-Coast Opportunities Your perfect practice is waiting for you at TeamHealth Anesthesia. We have practices throughout the United States, so whether you’re looking for cities, suburbs, mountains or beaches, we have the practice you want, where you want, just waiting for you to make it your own. Our partner hospitals range from community hospitals in comfortable bedroom townships to major
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• Recruit anesthesia medical directors who possess a strong customer service mindset, support their respective hospital’s vision and goals, communicate with surgeons to ensure mutual understanding of the ACT model to be implemented, have experience working with CRNAs and create positive group cultures.
AT A GLANCE ADDRESS 7111 Fairway Dr. Ste. 450 Palm Beach Gardens, FL 33418 Phone: (877) 799-3552 Email: anesthesiajobs@teamhealth.com Website: www.teamhealth.com
SERVICES TeamHealth Anesthesia is one of the nation’s leading outsourced anesthesia and pain management service organizations. Specializing in delivering high-quality, cost-effective and servicefocused patient care.
• Recruit and retain a core group of physicians and CRNAs. • Provide team-building workshops with anesthesia providers, surgical leadership and the hospital executive team. • Appoint an internal chief CRNA to help physicians and CRNAs work as a team. • Leverage TeamHealth’s national customer service training programs to improve satisfaction scores. • Implement daily anesthesia “team huddles” to ensure all processes are properly in place for surgeries and patients scheduled for the next day. By implementing the ACT model, our client hospitals are seeing faster room turnovers as well as drastically improved efficiency and reduced costs.
The right job. The right place. The right partner. TeamHealth Anesthesia is one of the nation’s leading outsourced anesthesia and pain management service organizations. Specializing in delivering high-quality, cost-effective and service-focused patient care, our services are designed to maximize OR performance while increasing patient and surgeon satisfaction. For more information, visit us online at www. teamhealth.com, call (877) 799-3552 or email anesthesiajobs@teamhealth.com.
This corporate profile was reviewed and approved by TeamHealth Anesthesia.
Advance Your Anesthesia Career TeamHealth Anesthesia has ideal practices for anesthesiologists and CRNAs all across the country.
Our team-oriented approach stresses service and quality patient outcomes in professional practice environments. If youâ&#x20AC;&#x2122;re looking for an attractive income and beneďŹ ts package, performance incentives, a variety of practice choices and career advancement, then visit teamhealth.com today.
The right job. The right place. The right partner.
www.teamhealth.com 877.799.3552 | anesthesiajobs@teamhealth.com
2013-2014
Corporate Profiles
ANNUAL
TELEFLEX
T
eleflex, through its Arrow®, Hudson RCI®, LMA® and Rusch® branded products, is dedicated to reducing complications and cost, protecting patients and caregivers, and improving patient outcomes with products that span the continuum of anesthesia—from the operating room to the recovery room, to critical care and beyond. We consult with clinicians and design our products to address modern clinical challenges, striving to help providers adapt to an ever-changing global health care environment.
LMA Airway Management™— LMA Better by Design® Teleflex is proud to welcome the LMA® brand into our portfolio of airway management solutions. LMA airways have a proven track record of safety and efficacy, building on a 20-year history of innovation and trust. The subject of more than 3,000 clinical references, each LMA airway has been carefully designed and tested to meet exacting standards. LMA airways are included in the American Heart Association Guidelines for Resuscitation and the American Society of Anesthesiologists Difficult Airway Algorithm. The LMA Supreme® single-use airway combines the best features of all previous LMA airways and is designed for safety and ease of use. Whether for a routine procedure or to manage a higher-risk patient, it is designed to channel fluids away from the airway in the unlikely event of active or passive regurgitation and allows for diagnostic testing and verifiable positioning.
The Next Generation in One-Lung Ventilation
The Rusch® EZ-Blocker™ endobronchial blocker is the next generation in one-lung ventilation, designed to enhance patient outcomes during selective procedures. Developed by an anesthesiologist for use by anesthesiologists to provide an improved device for lung isolation, the EZ-Blocker endobronchial device has a unique Y-shaped distal end that mirrors the bifurcation of the trachea. This unique end allows for the intuitive placement of the cuffs in the right or left bronchus. Once the EZ-Blocker endobronchial device is advanced through the distal end of a single-lumen endotracheal tube, the bifurcated cuffs separate and are naturally directed into the left and right main stem bronchi.
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The EZ-Blocker endobronchial device can be securely placed at the carina without the need for navigation of the cuff into either of the bronchi.1 With the EZ-Blocker endobronchial device, cuff inflation can be performed just before lung isolation, which minimizes the need to manipulate the catheter after placement and reduces the potential for the cuffs to become dislodged.
Needle-Free Solutions for Drug Delivery The LMA Atomization ® family of products provides a simple-to-use, needle-free solution for use with drugs approved for intranasal and oropharyngeal delivery. The LMA® MAD Nasal™ intranasal nucosal atomization device is the safe and painless way to deliver medication with rapid adsorption/transport across mucosal membranes to the bloodstream. The LMA® MADgic Airway™ intubating airway with mucosal atomization and oxygen delivery is the most innovative choice to create a temporary airway to facilitate fiber-optic intubation, combining atomized topical anesthetic and oxygen delivery in an innovative and elegantly designed oral airway. The LMA® MADgic® laryngo-tracheal mucosal atomization device is the most versatile choice to administer medication across the entire upper airway and beyond the vocal cords.
Post-Op Pain Management Solutions The Arrow® FlexBlock® echogenic continuous peripheral nerve block (cPNB) catheter and the AutoFuser® disposable pain pump can together provide clinicians with faster, more accurate catheter placement with a reliable, unimpeded infusion of medication. The Arrow® FlexBlock® cPNB catheter’s coil-reinforced, polyurethane body is designed to help improve cPNB success by providing clinicians with an echogenic catheter—visible under ultrasound—which also resists kinking. The result: a cPNB catheter designed to help better control your patient’s pain and improve overall block success. The AutoFuser disposable pain pump offers a combination of a continuous hands-free medication infusion with an optional on-demand patient-controlled bolus to immediately address breakthrough pain.
AT A GLANCE ADDRESS 155 South Limerick Road Limerick, PA 19468
PRODUCTS LMA® Airways, Rusch® EZ-Blocker™ Endobronchial Blocker, Rusch® ET Tubes and Laryngoscopes, ISO-Gard® Mask with ClearAir™ Technology, Arrow® Pain Management
EMPLOYEES 11,700
CHIEF EXECUTIVE OFFICER Benson Smith
Green Rusch Lite™ and Rusch® EquipLite™ disposable metal laryngoscope blades are single-use blades that offer users the performance and feel of a reusable metal blade. These blades eliminate the hassles associated with reusable blades, including the time and cost of reprocessing, without sacrificing strength or light quality.
Limiting Waste Anesthetic Gas Exposure In the PACU An invisible risk exists in the postanesthesia care unit (PACU). Patients are exhaling waste anesthetic gas into the breathing zone of their attending nurses,3 and although it cannot be detected by sight or odor, PACU clinicians can take action to protect themselves from the potential health effects. The first of its kind, the ISO-Gard® mask with ClearAir™ technology was developed by Teleflex in partnership with clinicians who identified the issue and wanted to take action. As the only solution available for “source control” of waste gases, the specialized ClearAir™ technology of the ISO-Gard® mask simultaneously delivers oxygen to patients and scavenges their exhalation to help limit exposure faced by clinicians.
References Reducing Cross-Contamination, Reducing Cost The risk for cross-contamination during intubation of the trachea exists because no perfect procedure for decontamination exists. 2 Single-use devices offer the opportunity to reduce potential for infection associated with reusable devices.
1. Mungroop H, Wai PTJ, Morei NM, Loef BG, Epema AH. Lung isolation with a new Y shaped bronchial blocker, the EZ-Blocker. Br J Anaesth. 2009;104:119-120. 2. Disposable laryngoscope blades do not interfere with ease of intubation in scheduled general anesthesia patients. Eur J Anaesthesiol. 2003;20:731-735. 3. Occupational Safety and Health Administration, U.S. Department of Labor. Anesthetic gases: guidelines for workplace exposures. Revised 18 May 2000. http://www.osha.gov/dts/osta/anestheticgases/. EquipLite is a trademark of Truphatek International Ltd. AutoFuser is a registered trademark of Ace Medical Co., Ltd. Teleflex, Arrow, ClearAir, EZ-Blocker, FlexBlock, Green Rusch Lite, Hudson RCI, ISO-Gard, LMA, LMA Airway Management, LMA Atomization, LMA Better by Design, LMA Supreme, MAD Nasal, MADgic, MADgic Airway and Rusch are trademarks or registered trademarks of Teleflex Incorporated or its affiliates.
This corporate profile was reviewed and approved by Teleflex.
THE INNOVATIVE WAY TO MAKE LUNG ISOLATION EASIER. ®
RUSCH EZ-BLOCKER
TM
The next generation in one-lung ventilation. The EZ-Blo ocker™ Endobron nchial Blocker B r is the next generation n of one-lung ventii lation produccts designed tto enhance pa atient outcomes during selectivve procedures. For more in nformation visit EZ-Bloc cker.co om.
INNOVAT IV E
IN T UIT IV E
SECUR E
The EZ-Blocker Endobronchial Blocker was developed by an anesthesiologist for use by anesthesiologists to provide an improved device for lung isolation. The EZ-Blocker Endobronchial Blocker has an innovative Y-shaped distal end that mirrors the bifurcation of the trachea which allows for intuitive, secure placement for lung isolation procedures.
Teleflex, EZ-Blocker and Rusch are trademarks or registered trademarks of Teleflex Incorporated or its affiliates. © 2013 Teleflex Incorporated. All rights reserved. 2013-1981
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TE CH N OL OG Y
Investigational Device Prolongs Survival Of Livers for Transplantation May increase availability of donor livers
P
atients who need a new liver to survive must hope that they are one of the approximately 13,000 liver transplant recipients in the United States and Europe each year. But with 30,000 people on waiting lists, and with only ice keeping livers for transplantation viable for up to 14 hours, the odds are not always in the patients’ favor. Each year, more than 2,000 livers don’t survive the journey to their new home. “Preserving organs by cooling them down is far from perfect,” said Peter J. Friend, MD, director of transplantation surgery in the Nuffield Department of Surgical Sciences at Oxford Transplant Centre, in the U.K. “Although cooling the organ on ice slows its metabolism by a factor of 10, the liver continues to metabolize slowly and deteriorates as a result. It’s hard to tell which organs will work and which ones won’t.” Now, however, Dr. Friend and his colleague Constantin Coussios, PhD, professor of biomedical engineering at the University of Oxford, have devised a novel technology that allows the liver to function for up to 24 hours, as though it were still inside a human body. On March 15, the team of engineers and physicians announced the preliminary success of this machine, which has safely transported livers to two transplant recipients at King’s College Hospital in London. “The first two cases went very well,” said Dr. Friend. “They weren’t exceptionally high risk, but the machine did what it was supposed to do.”
Long Time in the Making In 1994, Drs. Friend and Coussios devised the idea for the technology, but faced several engineering challenges while developing it. The co-inventors needed to create an artificial environment that could simulate the key functions of the human body, including pumping blood and providing nutrition to the organ. These functions not only had to be automated to make it possible for transplant surgeons around the globe to use the technology, but also small enough for easy transportability. After 15 years of developing and tweaking the design, Drs. Friend and Coussios have created a technology that appears to meet these requirements. The liver’s main blood vessels are connected to tubes on the machine, which automatically regulate the environment around the liver. The device maintains the liver at body temperature and infuses it with oxygenated red blood cells, nutrition such as glucose and amino acids, and other chemicals to create a physiologic environment that mimics the human body. The liver is not only kept alive, but it continues to produce bile as well. And, the machine is compact. “It’s about the size of a supermarket trolley [shopping cart], which means it can go in back of ambulance, small plane or helicopter,” Dr. Friend said. “Size was very important because we knew there was
A liver 30 seconds after connection to the OrganOx Metra device. Parts of the organ are still cold, while other parts are warm and perfused with red cell solution.
The liver 5 minutes after connection to the OrganOx Metra, now fully perfused and at physiologic temperature.
The King’s College Hospital, Oxford University and OrganOx team successfully connects the first human liver for transplantation to the OrganOx Metra device.
no point in making a machine if it couldn’t fit in the back of a vehicle.” Notably, the machine also may allow the liver to recover from injuries it sustained during or before removal, Dr. Friend pointed out. This function of the device is particularly important because it could expand the number of viable livers for transplantation. In recent years, the demand for livers has grown, as liver disease has become more common, whereas the quality of donor livers has diminished. “More and more, donors tend to be older, and have a high body mass index or coexisting major health problems,” Dr. Friend noted. “Because of the increasing demand for livers, we are having to use organs we would have once said no to.” Now with the machine, transplant surgeons can test how well the liver is working during preservation. “If the liver works on the pump, then we can assume it will work in the recipient,” said Maria B. Majella Doyle, MD, MBA, associate professor of surgery at Washington University School of Medicine, in St. Louis, who specializes in liver transplantation. Dr. Doyle was not involved in developing this pump, but she is performing research to develop a different liver pump system, one that also keeps the liver at physiologic temperature. In April 2008, Drs. Friend and Coussios cofounded a company called OrganOx Ltd., to continue their University of Oxford research. With financial support from the Royal Society and several venture capital funds in the United Kingdom, the company has been working to bring the technology to patients. Although promising, the device still needs more testing. The U.K. team has begun a pilot trial at King’s College Hospital to test the ability of the machine to transport livers to 20 transplant patients. If the trial is successful, OrganOx then could apply for marketing authority, which would make the device commercially available in Europe. “If the machine is as good as we believe, we would expect a significant increase in patients who get liver transplants,” Dr. Friend said. According to Dr. Doyle, the group is “ahead of the game.” To her knowledge, two other teams are developing physiologic-temperature liver pump systems— Dr. Doyle and her colleagues William Chapman, MD, and Vijay Subramanian, MD, at Washington University, and Constantino Fondevila, MD, PhD, at the University of Barcelona—but both are at more preliminary stages. “The U.K. team is the first to produce human data with the pump and show it’s safe and viable as a liver transplantation device. Now, it’s important to make sure the technology is foolproof and cost-effective,” Dr. Doyle said. “The U.K. team needs to be highly commended. The pump is a great achievement.” —Victoria Stern
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CONTINUED FROM PAGE 1
“Our department instituted a standardized policy with mandatory training and process audits regarding wrong-site blocks in June 2010,” said Mark Hudson, MD, MBA, associate professor of anesthesiology and vice chair for clinical operations at the University of Pittsburgh Medical Center (UPMC). “And it’s interesting that they continued to occur even after we tried to implement stops to prevent
them. So just having a policy in place, no matter how robust it may be, doesn’t completely eliminate wrongsite blocks, because it relies on people following the policy.” Dr. Hudson and his colleagues used quality improvement and billing data to determine the number of wrong-site blocks between July 2002 and June 2012 within the UPMC system. Between 2002 and 2010, each hospital was responsible for verification processes concerning nerve blocks.
The Wrong Side of Wrong-Site Claims
K
aren Domino, MD, MPH, who oversees the Closed Claims database, said there are 13 wrong-site block claims among the roughly 9,800 total in the pool. Of those, seven involve blocks of the lower extremities, two of the shoulder or upper extremities and four for eye procedures.
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“In all cases, the wrong-side block was noted prior to start of surgery, so there were no wrongside surgeries associated with these wrong-side blocks,” said Dr. Domino, professor of anesthesiology and pain medicine at the University of Washington, in Seattle. “In all cases, the consent and other documentation were clear regarding the surgical plan.” Injuries ranged from none to permanent but minor, she said; four claims involved temporary or nondisabling nerve injuries. At least two patients were admitted to the hospital as a result of the errant block. In at least six of the 13 cases, a payment was made on behalf of the anesthesiologists who performed the procedure, Dr. Domino said. The payout in 2012 dollars ranged from $3,750 to $19,500, she said. The most recent claim occurred in 2008, while only two were filed since 2003, the year before the Joint Commission issued its Universal Protocol on wrong-site surgery. The Closed Claims database does shed some light on why wrong-site blocks occur. According to Dr. Domino, reasons include verification—or a failure thereof—with patients who are sedated or who have dementia; lapses in confirming the correct site listed on the consent form; and, in one instance, sterile drapes covering the correct site and exposing the wrong one. “In another case, a timeout occurred, including checking with the patient regarding which side to block. However, the patient was then turned prone, and the wrong side was blocked,” she said. The lessons for clinicians from these cases are clear, Dr. Domino said: Triple-check the patient’s consent documentation; do not rely on patients’ answers—or those of the nurses—particularly when patients are sedated or have dementia; and watch out for incorrectly placed drapes when patients are turned or prone. —AN Staff
AUGUST 2013
AnesthesiologyNews.com I 43
CL IN ICA L A N E STH E SIOL OG Y Following a wrong-site block in June 2010, a mandatory time-out policy was developed. This evolved in March 2011 to a system-wide policy, which was approved and introduced across all system hospitals. All but one hospital performed blocks in a preoperative holding area. UPMC clinicians performed 169,508 blocks on 85,915 patients across the system during the study period. Nine wrong-site blocks occurred, for an incidence of 1.05 per 10,000 patients. The incidence of wrong-site blocks varied from none to three per year and none to three per location. As the investigators reported at the 2013 annual meeting of the American Society of Regional Anesthesia and Pain Medicine (abstract A20), five of the nine wrong-site blocks were femoral, two were lumbar plexus, one interscalene and one cervical.
‘So just having a policy in place, no matter how robust it may be, doesn’t completely eliminate wrong-site blocks, because it relies on people following the policy.’
surgeries (for which data were available for the past four years): Wrong-site blocks outnumbered wrong-site surgeries by a factor of 10. “I think there has been so much attention paid to wrong-site surgeries that now there are clearly defined policies and roles within that policy for the surgical team,” he explained. “That’s not necessarily the case for the block team.” And although the consequences may not be as serious for wrong-site blocks as they are for wrong-site surgery, that
does not mean they should be taken lightly. “I think any time a procedure is done on the wrong side, there’s a risk associated with it,” Dr. Hudson said. “Either way, this should be a zero event. It should never happen.” Stephen M. Rupp, MD, medical director of perioperative services at Virginia Mason Medical Center, in Seattle, noted that preventing wrongsite blocks goes well beyond simply creating new policies. “This is more about training and culture,” Dr. Rupp
said. “So you need the key opinion leaders in the department to speak up and say, ‘We’re going to do this.’ Once you’ve made that commitment, you need a poster visible in the room where the block is performed, to remind people of steps in the process,” Dr. Rupp continued. “Patients love when you create that environment; they love to hear you going through those steps. It’s reassuring to them.”
Some people just look at the surface. We go right to the core.
—Mark Hudson, MD, MBA “In looking at facilities, we examined sites with and without dedicated acute interventional pain programs,” Dr. Hudson told Anesthesiology News. When a member of the anesthesiology team rather than the dedicated interventional pain team performed the procedure, the frequency of wrong-site blocks nearly doubled. Although wrong-site blocks were recorded after the development of various policies, the incidence fell to about half its previous rate. Furthermore, review of these post-policyy cases revealed that in each instance, the care team did not follow approved policy. In one case, the team that performed the block differed from the team that performed the time-out. In the second case, the time-out was performed before the patient was positioned and marked. And in the most recent case, the patient’s marking was not visible when the block was performed. Yet for Dr. Hudson, perhaps the study’s most disturbing finding came when he compared the incidence of wrong-site blocks with wrong-site
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CONTINUED FROM PAGE 1
and observable biomedical standards,” added Alex Manara, a consultant in anesthesia and intensive care medicine at Frenchay Hospital, in Bristol, England. “A research agenda [is needed] to address outstanding knowledge gaps in this complex field,” Dr. Manara told the conference. Several trends magnify the need for consensus. These include the growing demand for multiple organs for transplantation, the need to harvest these organs from dead patients as quickly as possible and the development of new medical technologies that can prolong organ viability even in so-called brain-dead patients (see article, page 41). The widely accepted ethical “dead donor rule” prohibits the harvesting of vital organs for transplantation until after the donor has been declared dead. But this standard has become controversial following media reports of patients who had been declared dead from cardiac arrest but who revived several minutes later when their circulation spontaneously resumed. Such occurrences contribute to “the suspicion that arbitrary criteria of death have been implemented to enhance organ donation,” said Francesco Procaccio, MD, with the Italian National Transplant Center, in Rome. “In spite of widely accepted core criteria, procedures for declaring neurological death are different in various countries and the ‘no-touch’ period to determine circulatory death varies from two to five to 20 minutes,” Dr. Procaccio told Anesthesiology News. “These unfavorable factors contribute to uncertainty and public distrust.”
No Global Standards In the United States, the Uniform Determination of Death Act is the basis for each state’s legal definition of death. The act defines a dead person as one who has sustained either irreversible cessation of circulatory and respiratory functions, or irreversible cessation of all functions of the entire brain, including the brainstem. In the United Kingdom, death is defined as the irreversible cessation of brainstem function. And although guidelines of the American Academy of Neurology (AAN) generally are accepted as official ((Ann Neurol 2012;71:573-585), a survey of braindeath protocols in leading U.S. neurology departments “disclosed a shocking lack of standardization, despite availability of the accepted AAN guidelines for over a decade,” wrote James L. Bernat, MD, professor of neurology and medicine at Dartmouth-Hitchcock Medical Center, in Lebanon, N.H. (Nat Rev Neurol 2013;9:164-173). To complicate matters further, “each hospital can have their own specific lists of tests and criteria, and if the hospital does not have an official policy, it is up to the individual physician to make a determination of death as they see fit,” said Noam Y. Stadlan, MD, a neurosurgeon and pain specialist at NorthShore University HealthSystem, in Skokie, Ill. “Having an international discussion and attempt at consensus would be helpful as a means to clarify opinions and positions, as well as to try to bring the law into alignment with practice.” Current controversies center on two main issues, according to Dr. Bernat: Are “brain dead” patients truly dead, and in the circulatory determination of
Turning to Technology
A
lthough tools and technologies used to diagnose and confirm brain death are highly reliable, considerable uncertainty remains over such areas as the length of time needed for observation and the accuracy of newer tests to confirm cessation of whole brain function. In June 2010, the American Academy of Neurology (AAN) published an update to its 1995 guideline to determining brain death in adults (Neurologyy 2010;74;19111918). After reviewing the clinical evidence, the AAN’s Quality Standards Subcommittee found no published reports of recovery of neurologic function after a diagnosis of brain death had been made using 1995 criteria. However, the panel concluded there was “insufficient evidence to determine the minimally acceptable observation period to ensure that neurologic functions have ceased irreversibly. Apneic oxygenation diffusion to determine apnea is safe, but there is insufficient evidence to determine the comparative safety of techniques used for apnea testing. There is insufficient evidence
to determine if newer ancillary tests accurately confirm the cessation of function of the entire brain.” Determination of brain death involves examination to show irreversibility of the patient’s condition and to rule out alternative causes; neurologic examination to establish absence of all brain clinical functions; and in some cases, ancillary tests. For the latter, the preferred method is neuroimaging to document absence of intracranial blood flow using either single-photon emission computed tomography (CT), transcranial Doppler ultrasound or contrast angiography. Other techniques, which have not been validated, include radionuclide angiography, magnetic resonance angiography and CT angiography. A secondary option involves brain electrical potential recording by electroencephalography (EEG), plus brainstem auditory evoked and somatosensory evoked responses (Nat Rev Neuroll 2013;9:164-173). In 2009, a group of European anesthesiologists reported that the bispectral index (BIS) monitor might be a “useful adjunctive tool” to
providing an early indication of brain death in pediatric patients and allowing physicians to more efficiently employ resources in the hospital. The BIS monitor (Covidien) quantifies activity in the frontal cortex using an algorithm derived from EEG measures. Originally designed to track the depth of anesthesia in patients undergoing surgery, new uses for the monitor are emerging, said Antonio Pérez-Ferrer, MD, PhD, an anesthesiologist at La Paz Children’s Hospital in Madrid, Spain, and leader of the study. Future applications may include “neurological assessment of brain injury, cerebral ischemia or hypoxia, detection of brain-death onset and ICU sedation monitoring and management,” said Dr. Pérez-Ferrer, whose group presented its findings at the 2008 PostGraduate Assembly in Anesthesiology (abstract P-9116). Covidien declined to comment for this story because the company “does not have specific product claims for this topic,” said Caitlin McBrair Mayer, a Covidien spokesperson. —T.A.
death, how long must a physician wait after asystole before declaring death? Because criteria vary widely, “agreement on the exact moment of death remains surprisingly controversial,” he said. In the early 1990s, a pioneering protocol at the University of Pittsburgh allowed donor patients to be declared dead after two minutes of asystole and apnea. But critics then and since have argued that because patients often can be resuscitated at that point, the protocol violates the legal definition of death as irreversible cessation of circulation. Many groups have come to recommend waiting at least two minutes but no more than five minutes before declaring death. For example, the Society of Critical Care Medicine (Crit Care Medd 2001;29:1826-1831) and the National Conference on Donation After Cardiac Death ((Am J Transplantt 2006;6:281-291) require two to five minutes, whereas the U.S. Institute of Medicine and the Canadian Council for Donation and Transplantation (CMAJJ 2006;175:S1-S24) each recommends five minutes. Some European countries stipulate 10 minutes; Germany has no guidelines and Italy is proposing physicians wait 20 minutes before declaring death. Global Consensus Needed … but Unlikely An “international consensus on the definition of death would be desirable but is unlikely to occur in the near future because of cultural and religious differences among countries,” Dr. Bernat told Anesthesiology News. For example, most Catholic and Protestant denominations accept brain death as human death, as do Reform and Conservative Judaism. However, ultra-Orthodox rabbis and some Islamic denominations and countries do not. And as a country, neither does China. “The criteria for declaring death must be equal and simply understandable: Countries should have a simple and clear law for death determination independent from possible organ donation,” Dr. Procaccio said. ”The scientific community and particularly the anesthesiologic and intensive care societies should achieve consensus on universal criteria for determining death.” In consultation with an expert forum organized by Canadian Blood Services, the World Health Organization is developing international guidelines for death determination. Group members have produced a discussion framework and plan to grade evidence to confirm clinical standards. Dr. Manaraa argued that patients should be observed for at least five minutes to confirm absence of circulation before declaring death. “This should become the minimum standard” for circulatory death determination, Dr. Manara said. Doing so “will maintain professional and public confidence in the diagnosis of death.” Regardless of how guidelines may be revised, anesthesiologists should play a major role in the determination process, Dr. Procaccio said. “In most countries, anesthesiologists take care of patients with acute cerebral lesions or cardio-circulatoryy failure in the ICU and emergency department. Thus, they can properly identify patients who fulfill circulatory or neurologic criteria of death and manage the clinical situation to achieve death declaration and organ donation.” —Ted Agres
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C LIN I C A L A N ES THES IO LO G Y
Protocol Speeds Elective Surgery for Patients Starting Dialysis arrhythmias, and hypervolemia, which can ultimately cause acute congestive heart failure. The American Society of Anesthesiologists (ASA) does not have specific guidelines regarding the timing of elective surgeries for patients undergoing intermittent hemodialysis (IHD). However, according to researchers at Mayo Clinic, in Jacksonville, Fla.,
several published studies support the scheduling of elective surgeries within 24 hours of IHD. The researchers formalized this approach as a protocol within their hospital center after having observed several cases in which surgeries were delayed for emergent dialysis to correct electrolyte abnormalities and volume overload. Patients with ESRD who
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receive intermittent dialysis are identified through the preoperative interviewing process and medical record; they are scheduled to undergo elective surgeries less than 24 hours following dialysis; and preoperative laboratory tests are performed to check serum potassium level on the day of surgery to ensure proper management of potassium if the reading is greater than 5.0 mEq/L. “We started this scheduling protocol at Mayo Clinic Florida because we believed it was a simple way to avoid these complications and improve patient safety,” said anesthesiologist Sher-Lu Pai, MD, a co-author of the new study, which the researchers presented at the 2012 PostGraduate Assembly in Anesthesiology (abstract P-9101). “Hyperkalemia and hypervolemia are the well-known complications caused by missing routine hemodialysis,” Dr. Pai said. “Most of literature recommends that the serum potassium concentration be below 5.5 mEq/L for elective surgeries to avoid cardiac arrhythmias. Hyperkalemia and hypervolemia in this patient population make it more challenging for intraoperative blood transfusion and fluid resuscitation.” Dr. Pai and her team performed a retrospective chart review of all patients with ESRD who were on IHD and who underwent surgery during the period beginning five months before their proposed protocol was implemented through five months after implementation. They documented see dialysis page 53
CONTINUING MEDICAL EDUCATION
AUGUST 2013
Lesson 305: PreAnesthetic Assessment of the Child Requiring Multiple Organ Transplantation WRITTEN BY:
TARGET AUDIENCE
Herodotos Ellinas, MD Assistant Professor, Department of Anesthesiology, Medical College of Wisconsin, Milwaukee, WI
Anesthesiologists
LEARNING OBJECTIVES
REVIEWED BY: William Clarke, MD Associate Professor, Department of Anesthesiology, Medical College of Wisconsin, Milwaukee, WI
DISCLOSURES The authors, editor, and reviewer have declared no conflict of interest related to financial disclosures, research, and written presentation of this manuscript.
At the end of this activity, the reader will be able to: 1. Briefly summarize mitochondrial physiology. 2. Review the pathophysiology of MitoD. 3. Document the clinical presentation of MitoD. 4. Distinguish between different myopathies and their symptoms. 5. Evaluate and order basic tests in patients suspected of MitoD. 6. Identify any association of MitoD with malignant hyperthermia (MH). 7. Design an anesthetic plan for a patient with MitoD. 8. Describe the interaction of propofol in patients with MitoD. 9. Recognize implications about the use of various anesthetic agents in MitoD. 10. List perioperative considerations/complications for patients with MitoD.
PROFESSIONAL GAPS
CASE HISTORY
Mitochondrial disorders (MitoD) are a group of rare heterogeneous diseases involving genetic defects in mitochondrial proteins and function. Most anesthesiologists are unaware of the multisystem involvement that can complicate anesthetic management.
A 7-year-old girl (body weight, 26 kg) presented for multivisceral (liver, pancreas, and small bowel) transplantation for intestinal and liver failure. She had a long-standing history of intestinal pseudo-obstruction with multiple episodes of abdominal sepsis, and eventually was diagnosed with complex I mitochondrial disorder. She had received previous inhalational anesthetics, one followed by a hyperpyrexic course and dark urine and one unremarkable anesthetic with a total intravenous anesthetic technique (TIVA). Because of chronic abdominal pain, she was maintained on hydromorphone and was opioid-tolerant. Her preoperative evaluation revealed mild cardiomyopathy, mild coagulopathy, and normal intellect.
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.
Background MitoD are a heterogeneou us group of disorders with variable presentations deffined by a defect in one of the mitochondrial functtions such as Krebs cycle, fatty acid oxidation,, or oxidative phosphorylation (OXP PHOS). OXPHOS is the main sou urce for the formation of adenosine triphosphate (ATP), the main energy molecule for human cells, and a subclass of MitoD, the mitochondrial myopathies, is caused by OXPHOS defects. A pioneer in muscle disease research, Shy described mitochondrial prod life eration in myopathic patients as ea early as 1962.1 Since then,
PREANESTHETIC ASSESSMENT Dr. Elizabeth A.M. Frost, who is the editor of this continuing medical education series, is clinical professor of anesthesiology at the Mount Sinai School of Medicine in New York City. She is the author off Clinical Anesthesia in Neurosurgery (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 posttest and course evaluation before July 31, 2014. (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: August 1, 2013 TERMINATION DATE: July 31, 2014 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.
many other researchers have contributed work in this field, with significant publications appearing in 1995. Over the past 20 to 30 years, an increasing number of diseases have been identified as MitoD. These disorders are rare, with an estimated incidence of about 1:4,000, but the variable symptomatology makes this number most likely an underestimate.1 To date, more than 500 mutations (updated frequently) to the mitochondrial genome have been reported in the MITOMAP database (www.mitomap.org).
Mitochondrial Physiology Mitochondria are intracellular organelles consisting of an outer membrane and a folded inner membrane. Embedded in the inner mitochondrial membrane are 5 multimeric proteins involved in OXPHOS known as mitochondrial complexes I to V.2,3 Mutations in any of these proteins can produce a range of clinical diseases.3 These organelles also contain the rate-limiting enzymes for
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 Creditsâ&#x201E;˘. Physicians should claim only the credit commensurate with the extent of their participation in the activity. 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.
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CONTINUING MEDICAL EDUCATION
This lesson is available online at www.mssm.procampus.net
pyrimidine biosynthesis (dihydroorotate dehydrogenase) and heme synthesis (D-aminolevulinic acid synthase) required to make hemoglobin. In the liver, mitochondria are specialized to detoxify ammonia in the urea cycle. Mitochondria also are required for cholesterol metabolism, synthesis of estrogen and testosterone, neurotransmitter metabolism, and the production and detoxification of free radicals. The first step of the respiratory chain/OXPHOS process is the conversion of NADH to NAD; it also is the most common site of mitochondrial aberrations. The 3 major anomalies that involve this step are the often fatal infantile multisystem disorder, myopathy, and mitochondrial encephalopathy. The latter 2 forms have a variable course and prognosis, and other than metabolic supplements and dietary modifications to slow down the disease, multivisceral organ transplantation may be the only available definitive treatment. Mitochondrial inheritance behaves differently from autosomal and sex-linked inheritance. Nuclear DNA has 2 copies per cell (except for sperm and egg cells), one copy being inherited from the father and the other from the mother. On the other hand, mitochondrial DNA (mtDNA) is strictly inherited from the mother and each mitochondrial organelle typically ends up containing multiple mtDNA copies. During cell division, these copies segregate randomly between the mitochondria of the resulting 2 daughter cells, and then those mitochondria replicate more copies of their mtDNA. Although a process called mitophagy allows for selective removal of defective mitochondria, when imbalance of mutated mtDNAs to wild-type mtDNAs within the mitochondrial network reaches a critical point, the threshold, mitochondrial diseases may become clinically apparent.
Classification Although muscle biopsies can be nonspecific, tissue staining with modified GĂśmĂśri trichrome allows for a general division of these disorders into those with the presence of ragged-red fibers and those without. Subsarcolemmal accumulation of abnormal mitochondria with this stain gives rise to an intense red appearance over a blue myofibril background. Two additional histologic stains (cytochrome oxidase and succinate dehydrogenase) have allowed for a better delineation of these disorders (Table 1).4 Other diseases associated with mitochondrial dysfunction include diabetes mellitus and deafness (the combination at an early age can result from mitochondrial disease); Wolff-Parkinson-White syndrome; and mitochondrial neurogastrointestinal encephalopathy (MNGIE, a gastrointestinal pseudo-obstruction with neuropathy). Another classification of these disorders uses the clinical manifestations attributed to OXPHOS complex deficiencies. Although most have an acronym label, most people affected by these diseases do not have a syndrome but instead have a single isolated mutation. Deficiencies of each of the respiratory chain complexes can result in separate conditions such as complex I (NADHCoQ reductase) deficiency. Deficiencies of these complexes both individually and in combination have been associated with ragged-red and nonâ&#x20AC;&#x201C;ragged-red fiber disorders.
AUGUST 2013
Table 1. Mitochondrial Disorders MitoD
Age of Diagnosis
Manifestations
Kearns-Sayre syndrome
>5 y <15 y
Progressive external ophthalmoplegia, retinitis pigmentosa, cardiac conduction defect, dilated cardiomyopathy
MELAS
Late childhood/young adulthood
Central nervous system symptoms: strokes, seizures, headaches; lactic acidosis, cardiac conduction defect; cardiomyopathy
MERRF
Childhood/young adulthood
Seizures, progressive mental retardation
PEO
Adulthood
Similar to Kearns-Sayre syndrome
Pearson syndrome
Infancy to childhood, usually fatal
Refractory sideroblastic anemia, insulindependent diabetes mellitus, exocrine pancreatic dysfunction
Leigh encephalopathy
Infancy to childhood
Diffuse encephalopathy, dysphagia, hypotonia, central respiratory insufficiency
NARP
Young adulthood
Weakness, ataxia, retinopathy, learning disability
LHON
Young adulthood (25 y-35 y)
Painless loss of central vision
Clinical Presentation Table 2. Thor-Byrne-ier Criteria The presence of mitochondria in all tissues except red blood cells makes possible involvement of all body systems.1,4 The multitude of mutations seen makes the presentation unpredictable even among relatives. For example, Leigh syndrome can present differently within the same family and can be inherited both in a maternallike or Mendelian pattern.4 Progressive muscle weakness and exercise intolerance usually are the main symptoms.5 Although weakness of the muscles controlling the eyes and eyelids can be a prominent feature in some patients, in others, weakness of the muscles of the face and neck with subsequent difficulty in speech and swallowing may be the principal clinical manifestation. The degree of exercise intolerance varies with each individual; in some, problems with walking are the issue, in others jogging or more vigorous activities exacerbate symptoms. Muscle pain and muscle injury can result in rhabdomyolysis and myoglobinuria, with the end result of renal insufficiency and failure. Because deficiency in the production of ATP is the end result of these disorders, organs with high energy demands such as the brain, heart, and kidneys also may be affected. Headaches, hearing deficit, visual impairment, seizures, and learning disability with mental retardation can be the brain manifestations of ATP insufficiency (eg, mitochondrial encephalopathy with lactic acidosis and stroke-like episodes [MELAS; Figure]). Peripheral nervous system involvement with either sensory or autonomic dysfunction provides additional clues toward a more specific diagnosis, such as MNGIE, during neurologic examination. Cardiac conduction abnormalities requiring placement of a pacemaker and cardiac muscle damage with cardiomyopathies of both dilated and hypertrophic varieties are common concerns. Nonspecific nephropathy and renal tubular acidosis are additional red flags for these disorders. Other affected systems include respiratory, with shortness of breath and insufficiency requiring ventilator support; the gastrointestinal tract, with symptoms ranging from unexplained vomiting and dysphagia to intestinal
Major Clinical mitochondrial disorder or unexplained infant death >2% ragged red fibers Depressed enzymatic activity mtDNA mutation Minor Clinical symptoms without formal diagnosis Electron microscopy changes mtDNA unidentified mutation Abnormal laboratory data (lactate, pyruvate) Impaired positron emission tomography Impaired proton magnetic resonance spectroscopy
pseudo-obstruction and liver failure; and endocrine organs with diabetes, exocrine pancreatic insufficiency, hypoparathyroidism, hypothyroidism, and hypogonadism. All manifestations may lead to failure to thrive and an overall developmental regression.4
Diagnostic Considerations Evaluation for MitoD is especially important if energyintense organs such as the brain, heart, and eyes are involved and progressive worsening is noted.1,6 Clinicians should pay particular attention to symptoms such as myo-clonus and ataxia, unexplained heart block in a child, cardiomyopathy with lactic acidosis, and neonatal failure to thrive, as well as to lactic acidosis and hypotonia.1,5,7 Unfortunately, most symptoms are still nonspecific and may differ upon age of presentation,
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Table 3. Laboratory Evaluation Complete blood count Electrolytes and glucose Creatinine Liver tests and ammonia Coagulation parameters Creatinine phosphokinase Plasma lactate and pyruvate levels Plasma amino acids Urine organic acids
complicating diagnosis. Diagnostic criteria referred to as the Thor-Byrne-ier criteria for diagnosis of mitochondrial cytopathy (Table 2) can be helpful but are not 100% inclusive.8-10 Although abnormal test results may support the diagnosis of MitoD, a single normal test cannot rule it out (Table 3). Vasta et al11 recently found that using the redox status of coenzyme Q10 (CoQ10) in a nematode can be a diagnostic tool not only to identify respiratory chain complex disorders but also to monitor treatment. Magnetic resonance imaging (MRI) of the brain, audiology testing, ophthalmologic exam, and electroencephalogram may identify involvement of the central nervous system, whereas electrocardiogram and echocardiogram may detect cardiac disease. Skin biopsy can provide information on both lactate and pyruvate and electron transport chain enzymes and therefore allow for detection of a mitochondrial anomaly. Skeletal muscle biopsy can define morphologic anomalies and offer a biochemical analysis.12 Both can provide invaluable information but, again, without 100% sensitivity. Fresh muscle biopsy, which allows for specific biochemical testing, may provide better results but can be expensive (up to $10,000 for a complete analysis), and is performed only in a few centers in North America. Karyotyping and genetics consultation may allow allocation of resources and support of patients with developmental and learning disabilities.
Management of Mitochondrial Disorders No cure for MitoD is currently available. Management is directed at ameliorating symptoms of each disorder, organ manifestation, and complications. Although many neurologists recommend nutritional supplements, including vitamins and antioxidants, there is little data of their effectiveness other than CoQ10 supplementation.13 Ubiquinone (CoQ10) gel, approved by the FDA in 1999 as an orphan drug, is present in the mitochondria of eukaryotic cells and is an active element of the electron transport chain and a free-radical scavenger. Because of its antioxidant properties, it is listed among supplements and medications useful for various disease processes. Because of its participation in oxidative phosphorylation and its minimal side effects, it is listed as a possible therapeutic agent in MitoD.13,14
Carnitine infusion is a common additive used in MitoD. Although primary carnitine deficiency is not a common characteristic of these disorders, free carnitine levels are lower than normal in OXPHOS disorders. The possibility of restoring carnitine levels and improving β-oxidation has placed L-carnitine on the list of supplements used for many patients with or without carnitine deficiency, although the benefit may be evident in the former with improvement in muscle strength, cardiomyopathy, or gastrointestinal motility.13,14 Other additives include L-arginine, L-creatine, total parenteral nutrition (TPN), or simply high-dextrose infusions, all of which should be continued intraoperatively to avoid a metabolic crisis.
Malignant Hyperthermia and Mitochondrial Disease The presentation of malignant hyperthermia (MH) first was documented by Denborough in 1960 after a 21-year-old student in Melbourne, Australia, with a family history of multiple deaths during or after anesthesia nearly died after a halothane anesthetic. At a later conference in Toronto in 1966, additional cases were identified and the disorder was labeled as MH.15 Although there are concerns regarding anesthesia and MH, the only known myopathy disorders with true association with MH and the need for nontriggering anesthesia are central core disease, King-Denborough syndrome, and Evans myopathy. For the undiagnosed myopathic patient, a nontriggering technique should be employed, but the estimated risk for MH or rhabdomyolysis based on record review in a population of children with suspected neuromuscular dystrophy is less than 1%.16 Two earlier reports of MH in association with MitoD have been recorded.17,18 Another review discusses normal general anesthetic administration in a 60-year-old man with a subsequent positive in vitro contracture test.19 Most recent anesthesia reviews have suggested that nontriggering anesthetics are not required for the management of these disorders. A wide range of anesthetic techniques has been used including volatile anesthetic agents and TIVA20,21 or regional with local anesthetics.22,23 MitoD, especially MELAS, are now considered to have separate pathologies from MH.
Anesthetic Considerations Surgery for Patients With MitoD Apart from all surgeries typically required in children, patients with MitoD often present for procedures to diagnose their disease or for procedures to manage the course of the disease or its complications. For example, patients with low muscle tone may present for muscle biopsy or brain imaging studies; patients with seizures may require computed tomography or MRI; patients who fail to thrive may need gastric or jejunal tubes or central access placement; patients with a history of gastroesophageal reflux, aspiration, or pneumonia may require bronchoscopies, gastroscopies, or fundoplication surgery. In extreme cases, anesthesia is indicated for laparotomy or intestinal transplantation. As patients with MitoD present with a wide range of symptoms and disease severity, the anesthetic plan must be individualized. Patients with minimal symptoms for
minor procedures may be safely managed as outpatients with standard anesthetics, while patients with severe symptoms may need postoperative admission to the ICU, perhaps even preoperative admission for evaluation and management. Preoperative Evaluation and Workup Patients with MitoD should be interviewed by the anesthesiologist early so that history, physical examination, and available diagnostic testing can be reviewed and additional tests and interventions pursued. Communication with the primary physician and specialty physicians (neurology, cardiology, pulmonary, endocrinology, and metabolism) is mandatory to assure stable current status and course of the disease and form a perioperative plan. An ICU bed should be available for postoperative care. Neurologic evaluation includes assessment of mental status and disabilities. Seizure control should be optimized, medications adjusted accordingly, and drug levels documented. Depending on the surgery, a change of enteral to intravenous anticonvulsants should be planned and initiated. Cardiac evaluation may include a 12-lead electrocardiogram, chest x-ray, or echocardiogram to evaluate dysrhythmias, cardiomyopathy, and overall cardiac function. Pulmonary tests are needed to evaluate any respiratory insufficiency associated with muscle weakness. Chest x-ray, pulmonary function tests, and analysis of arterial blood gas may be indicated depending on the severity of the disease. Metabolic and laboratory testing is directed at evaluation of metabolic control and other organ dysfunction; liver function tests, renal function parameters, electrolytes, creatinine phosphokinase, lactate, and glucose levels are the minimum requirements; complete blood count and coagulation profile may be indicated depending on the surgical procedure.23 Preoperative Management Patients with MitoD may require preoperative admission even for minor surgery, for additional preoperative testing (Table 3), for initiation of IV anticonvulsant therapy for seizure control, or for IV dextrose-containing solution to reduce the risk for metabolic crisis related to fasting with fluid deficit and hypoglycemia.6,23,24 Patients on TPN are maintained on their infusion; otherwise, an infusion of 5% to 10% dextrose with 0.45% NaCl at maintenance rate is recommended preoperatively.22,25 Patients should be scheduled early in the day to allow for standard fasting guidelines with a minimum of 6 to 8 hours of solid meal avoidance and 2 hours for clear liquids. In the case of brittle patients or infants, initiation of IV fluids with glucose is warranted to avoid a crisis. However, patients remain at higher risk for aspiration because of bulbar muscle weakness and gut dysmotility. Intraoperative Management Monitoring. In addition to standard American Society of Anesthesiologists monitoring, arterial cannulation may be indicated for continuous hemodynamic monitoring as well as for frequent blood gas analyses for acidâ&#x20AC;&#x201C;base, electrolytes, blood glucose, and lactate levels. Perioperative venous access, either peripheral or central, is essential for the maintenance of dextrose infusion, and for major
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surgeries and laparotomies placement of a central line may be prudent to avoid interruption of dextrose infusion. Insulin infusion may be required to balance the dextrose infusion and maintain homeostasis. Normothermia should be the goal to prevent added stress and increase in metabolic demands. Induction. Full stomach precautions with rapid sequence induction and cricoid pressure may be indicated. Safe induction agents in patients with MitoD appear to be etomidate, ketamine, and methohexital. An induction dose of propofol likely is safe. Although there is a paucity of data regarding succinylcholine and MitoD, its association with MH in one case report and possible rhabdomyolysis and hyperkalemic response make it prudent to consider avoiding this agent.17 Although all muscle relaxants can have an effect on the hypotonic child, rocuronium has been reported in more than one case to be safe but should be administered in a reduced dose in the presence of muscle weakness or hepatorenal insufficiency. Fluid management. TPN should be continued intraoperatively or transitioned to 10% dextrose with electrolytes at maintenance rate. Patients on IV carnitine should receive the scheduled doses intraoperatively. Additional fluid requirements are replaced with lactate-free electrolyte infusions. Normal saline (0.9% NaCl) in large quantities may result in additional hyperchloremic metabolic acidosis and a lactate-free balanced solution may be beneficial. Blood loss should be replaced with synthetic colloids, albumin, or blood products as indicated based on hemodynamic measurements or poor end-organ perfusion, as indicated by ST-T changes or low urinary output. Choice of anesthetic agents: Although adequate stress protection of patients with mitochondrial disease is desirable, the choice of safe anesthetic agents for maintenance of anesthesia remains controversial. Volatile anesthetics have been used in MitoD without complications, although they have been shown to impair OXPHOS by inhibition of complex I.22 This effect in turn can impair central nervous system metabolism and cause cardiac dysfunction, leading to a potential increase in sensitivity to these agents. TIVA has been advocated by many as a generally safer, nontriggering anesthetic technique. However, propofol in a continuous infusion as part of a TIVA technique may be contraindicated. Evidence suggests that propofol’s lipid component may affect oxidation of fatty acids; in addition, the agent has a direct effect on the mitochondrial respiratory chain. Both of these effects may predispose patients to changes seen also in propofol infusion syndrome,27,28 a syndrome characterized by lactic acidosis, bradycardia, rhabdomyolysis, and cardiac and renal failure. It is associated mainly with longer duration infusions (>48 hours), but in susceptible patients even short-term infusions can cause symptoms. Ketamine has not been implicated as a deleterious agent in MitoD, and its analgesic properties can be a welcome adjunct to overall anesthetic management.22 Benzodiazepines and opioids generally are considered safe, and a 2011 case report by Schwartz et al reported on the successful use of dexmedetomidine and remifentanil in a child with mitochondrial myopathy.
AUGUST 2013
returned to baseline neurologic, cardiorespiratory, metabolic, and gastrointestinal status. Hospital admission for patients undergoing procedures normally performed in the outpatient setting may be indicated.
Management of the Case Presented
Figure. Modified Gomori trichrome stain in MELAS showing ragged red fibers (arrows) MELAS, mitochondrial encephalopathy with lactic acidosis and stroke-like episodes From: J Med Case Rep. 2009;3:77
Regional anesthesia may be an attractive alternative or addition, but local anesthetics have been shown to impair OXPHOS as well and may lead to inefficient synthesis of ATP.6 Clinically, however, regional anesthesia has been used successfully, and supporters indicate that it may allow a decrease in the dosage of opioids and thus lower the risk for respiratory depression with worsening acidosis. In addition, if a regional technique is used alone, both volatile anesthetics and propofol with their respective concerns can be avoided. Postoperative Management Minimizing metabolic stress and avoidance of increases in metabolic demands are important goals in postoperative management.24 Smooth emergence and extubation, normocarbia, cardiorespiratory stability, and effective analgesia are important. Depending on the baseline degree of muscle weakness, respiratory compromise, operative course, and the potential for postoperative respiratory depression, patients with MitoD may require postoperative ventilation. Even following early extubation, initial postoperative management in an ICU may be justified to monitor and manage cardiopulmonary and metabolic status, pain, and seizures. Multidisciplinary follow-up is advisable. Postoperative pain management is particularly important and a multimodal approach should be pursued incorporating local, peripheral, and neuraxial regional anesthesia as well as opioids intermittently or by patientcontrolled analgesia; nonsteroidal anti-inflammatory drugs and other opioid-sparing analgesics such as acetaminophen, either enterally or intravenously; and α-agonists and ketamine. Shivering should be treated aggressively with active standard techniques of warming blankets and meperidine to reduce the associated increase in oxygen consumption. Glucose and electrolyte levels should be normalized. Preoperative patient management is reinstituted, and patients should not be discharged until they have
The child received a diagnosis of MitoD, complex I deficiency, after a muscle biopsy was performed because of worsening motor skills and presence of urine organic acids. She experienced several episodes of sepsis requiring colectomy and ileostomy, leading to chronic abdominal pain. After developing high fever with the use of inhalational anesthetics, she was declared MH-susceptible and underwent further uneventful anesthetics using a trigger-free technique. Despite her multiple hospitalizations, she had normal cognitive, cardiac, and renal function. Her recurrent septic episodes resulting from her bowel dysmotility and the combination of intestinal failure and liver dysfunction made her a good candidate for multiorgan transplant, specifically liver, pancreas, and small bowel. The patient underwent an uneventful anesthetic course with TIVA, which included infusions of fentanyl (4 mcg/kg per hour) and ketamine (100 mcg/kg per minute) with intermittent doses of midazolam. Invasive blood pressure and central venous pressure were monitored. Infusion of L-carnitine and lactate-free crystalloid were provided to avoid metabolic derangements. A 20% dextrose solution and an insulin drip were infused to maintain blood glucose levels between 100 and 150 mg/ dL. The total fluid infusion included 2,700 mL of crystalloid and colloid, 6 units of blood (packed red blood cells and fresh frozen plasma), with an estimated blood loss of approximately 500 mL. Her urinary output was maintained with a total of 1,700 mL (>5 mL/kg per hour). The last arterial blood gas in the operating room showed a normal pH (7.39), hematocrit of 30, glucose of 142, and base excess of –2.4. After approximately 11 hours in the operating room, the patient was taken to the ICU. She remained hemodynamically stable, was extubated on postoperative day 1 and remained hospitalized for 3 weeks, whereupon she was discharged home off TPN and opioids. More than 6 months later, she remains in good condition with mild rejection of her transplant organs but adequately controlled with immunosuppressants.
Conclusion Although uncommon, MitoD can pose many challenges for the practicing anesthesiologist. No one “safest” anesthetic exists for these cases; the choice of anesthetic should be individualized to the needs of the particular patient. Consultation with experts in the field and the subspecialists in a multidisciplinary approach can provide excellent assistance with comorbid issues and allow for good prognosis even in patients with multiorgan disease. Multivisceral organ transplantation is associated with long anesthesia times, large blood loss, massive fluid shifts, and profound disturbances in metabolism, electrolytes, and acid–base status. Diligence and careful perioperative planning can allow safe anesthesia with good results.
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References 1.
United Mitochondrial Disease Foundation. www.umdf.org. Accessed June 2013.
2.
Schapira AH. Mitochondrial disease. Lancet. 2006;368(9529):70-82.
3.
DiMauro S, Schon EA. Mechanisms of disease: mitochondrial respiratory-chain diseases. N Engl J Med. 2003;348(26):2656-2668.
4.
Daroff RB, Bradley WG. Bradley’s Neurology in Clinical Practice. 6th ed. Chap 6:1473-1487. Philadelphia, PA: Elsevier/Saunders; 2012.
5.
van Adel BA, Tarnopolsky MA. Metabolic myopathies: update 2009. J Clin Neuromuscul Dis. 2009;10(3):97-121.
6.
Muravchick S, Levy RJ. Clinical implications of mitochondrial dysfunction. Anesthesiology. 2006;105(4):819-837.
7.
Haas RH, Parikh S, Falk MJ, et al. Mitochondrial disease: a practical approach for primary care physicians. Pediatrics. 2007;120(6): 1326-1333.
8.
Cohen BH, Gold DR. Mitochondrial cytopathy in adults: what we know so far. Cleve Clin J Med. 2001;68(7):625-626.
9.
Walker UA, Collins S, Byrne E. Respiratory chain encephalomyopathies: a diagnostic classification. Eur Neurol. 1996;36(5):260-267.
10. Bernier FP, Boneh A, Dennett X, et al. Diagnostic criteria for respiratory chain disorders in adults and children. Neurology. 2002; 59(9):1406-1411. 11. Vasta V, Sedensky M, Morgan P, Hahn SH. Altered redox status of coenzyme Q9 reflects mitochondrial electron transport chain deficiencies in Caenorhabditis elegans. Mitochondrion. 2011; 11(1):136-138.
12. Mitochondrial Medicine Society’s Committee on Diagnosis, Haas RH, Parikh S, Falk MJ, et al. The in-depth evaluation of suspected mitochondrial disease. Mol Genet Metab. 2008;94(1):16-37. 13. Hart PE, Lodi R, Rajagopalan B, et al. Antioxidant treatment of patients with Friedreich ataxia: four-year follow-up. Arch Neurol. 2005;62(4):621-626. 14. Parikh S, Saneto R, Falk MJ, Anselm I, Cohen BH, Haas R, Medicine Society TM. A modern approach to the treatment of mitochondrial disease. Curr Treat Options Neurol. 2009;11(6):414-430. 15. Denborough M. Malignant hyperthermia. Lancet. 1998; 352(9134):1131-1136. 16. Flick RP, Gleich SJ, Herr MMH, Wedel DJ. The risk of malignant hyperthermia in children undergoing muscle biopsy for suspected neuromuscular disorder. Paediatr Anaesth. 2007;17:22-27. 17. Ohtani Y, Miike T, Ishitu T. A case of malignant hyperthermia with mitochondrial dysfunction (letter). Brain Dev. 1985;7:249. 18. Fricker RM, Raffelsberger T, Rauch-Shorny S, et al. Positive malignant hyperthermia susceptibility in vitro test in a patient with mitochondrial myopathy and myoadenylate deaminase deficiency. Anesthesiology. 2002;97(6):1635-1637. 19. Finsterer J, Michalek-Sauberer A, Höftberger R. Malignant hyperthermia susceptibility in a patient with mitochondrial disorder. Metab Brain Dis. 2009;24(3):501-506. 20. Schnabel RM, Marcus MA, Theunissen HM, Janssens MM. Anesthetic management for a child with mitochondrial complex II deficiency. Paediatr Anaesth. 2008;18(8):802-803.
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.
21. Footitt EJ, Sinha MD, Raiman JA, Dhawan A, Moganasundram S, Champion MP. Mitochondrial disorders and general anaesthesia: a case series and review. Br J Anaesth. 2008;100(4):436-441. 22. Allison KR. Muscular dystrophy versus mitochondrial myopathy: the dilemma of the undiagnosed hypotonic child. Paediatr Anaesth. 2007;17(1):1-6. 23. Shipton EA, Prosser DO. Mitochondrial myopathies and anaesthesia. Eur J Anaesthesiol. 2004;21(3):173-178. 24. Gurrieri C, Kivela JE, Bojanić K, et al. Anesthetic considerations in mitochondrial encephalomyopathy, lactic acidosis, and strokelike episodes syndrome: a case series. Can J Anesth. 2011;58(8): 751-763. 25. Driessen JJ. Neuromuscular and mitochondrial disorders: what is relevant to the anaesthesiologist? Curr Opin Anaesthesiol. 2008; 21(3):350-355. 26. Kam PC, Cardone D. Propofol infusion syndrome. Anaesthesia. 2007;62(7):690-701. 27. Vasile B, Rasulo F, Candiani A, Latronico N. The pathophysiology of propofol infusion syndrome: a simple name for a complex syndrome. Intensive Care Med. 2003;29(9):1417-1425. 28. Lerman J. Perioperative management of the paediatric patient with coexisting neuromuscular disease. Br J Anaesth. 2011; 107(suppl 1): i79-i89.
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 Mount Sinai School of Medicine, New York, NY.
Post-Test 1.
The most common site of mitochondrial aberrations is ______________. a. inner mitochondrial membrane b. complex I deficiency (conversion of NADH to NAD) c. complex V deficiency (final pathway) d. outer mitochondrial membrane
2.
The most common presentation of mitochondrial disorders (MitoD) is ______________. a. renal failure b. congestive heart failure and conduction abnormalities c. progressive muscle weakness and exercise intolerance d. seizures and learning disability
3.
4.
5.
In patients with MitoD, which of the following should be obtained in all patients? a. Cerebrospinal fluid studies b. Karyotyping c. Basic chemistries, glucose, and serum lactate d. Renal ultrasound Which of the following myopathies is known for its association with malignant hyperthermia? a. Kearns-Sayre syndrome b. Central core disease c. Mitochondrial encephalopathy with lactic acidosis and stroke-like episodes d. Pearson syndrome In patients with MitoD, meeting metabolic demands is accomplished by _______________. a. hypothermia b. fluid replacement with lactated Ringer’s solution only c. continuous muscle relaxation intraoperatively d. seizure control
6.
Preoperative evaluation for the patient with MitoD includes all of the following except: a. 12-lead electrocardiogram b. Electroencephalogram c. Arterial blood gas d. Pulmonary function tests
7.
Recommended intraoperative monitoring for MitoD patients may include all of the following except: a. Swan-Ganz catheter b. invasive blood pressure c. temperature d. central venous pressure
8.
Which of the following medications does not interact with the respiratory chain and oxidative phosphorylation? a. Propofol b. Sevoflurane c. Ketamine d. Bupivacaine
9.
Propofol infusion syndrome is characterized by all of the following except: a. lactic acidosis b. tachycardia c. rhabdomyolysis d. renal failure
10. Possible complications for MitoD patients during anesthesia are least likely to include which of the following? a. Lactic acidosis b. Hypoglycemia c. Metabolic derangements d. Metabolic alkalosis
51
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A Practical Approach to Transesophageal Echocardiography: Third Edition
Albert C. Perrino Jr.; Scott T. Reeves August 26, 2013 This book offers a concise illustrated guide to the current practice of perioperative transesophageal echocardiography (TEE). Anesthesiology and cardiology practitioners will find this an indispensible resource to the physics, examination protocols, and practice pitfalls of TEE.
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Comprehensive Treatment of Chronic Pain by Medical, Interventional, and Integrative Approaches: The American Academy of Pain Medicine Textbook on Patient Management
Timothy R. Deer; Michael S. Leong; Asokumar Buvanendran; Vitaly Gordin; Philip S. Kim October 24, 2012 This textbook covers medical, interventional and integrative approaches to the treatment and management of pain. It is designed as a practical and comprehensive primary reference for physicians and is also a resource for preparing for certification examinations in pain medicine.
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Handbook of Clinical Anesthesia
Paul Barash; Bruce F. Cullen; Robert K. Stoelting; Michael Cahalan; M. Christine Stock; Rafael Ortega April 18, 2013 This handbook presents the essential information found in Clinical Anesthesia in a concise, portable format. Chapters have been completely updated, and a new chapter covering anesthesia for laparoscopic and robotic obot c surgeries su ge es has as been bee added. added
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Smith and Aitkenhead’s Textbook of Anaesthesia: Sixth Edition
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AnesthesiologyNews.com I 53
CL IN ICA L A N E STH E SIOL OG Y
preoperative lab values, whether the patient received IHD within 24 hours of surgery and whether surgery was emergent or elective. Dr. Pai’s group identified 163 cases (86 elective and 77 emergent) of ESRD patients on IHD; 84 surgeries were performed on these cases (41 preprotocol and 43 post-protocol). The protocol reduced the number of elective surgeries in ESRD patients scheduled more than 24 hours after IHD from 36.6% to 11.6%. “We have found that when ESRD patients on hemodialysis were identified, the team—surgeons, anesthesiologists and nursing staff—worked together to create a better result,” Dr. Pai said. “This was done through timely scheduling of elective surgery, as well as proper attention to preoperative lab results and patient-specific intraoperative management.” “We think it is a simple protocol,” Dr. Pai said. Because all the end-stage renal disease patients at Mayo Clinic Florida receive preoperative workk ups,
hemodialysis patients can be identified prior to scheduling OR time. Once the patients are identified, the elective procedures are usually scheduled the day after their hemodialysis session. For example, if a patient is on Monday, Wednesday, Friday hemodialysis sessions, the surgery will be scheduled on Tuesday or Thursday. For such a system to succeed, Dr. Pai noted, surgical schedulers must communicate closely with the preoperative evaluation clinic. “Since the beginning of the protocol, we also observed that the surgeons had been identifying the hemodialysis patients at their surgical clinics and conveying the information directly to the schedulers. It is not too difficult to implement the protocol,” Dr. Pai added, “as patient safety and cost-effectiveness are the common goals for both the anesthesia and surgery teams.” D. John Doyle, MD, PhD, professor of anesthesiology at the Cleveland Clinic Lerner College of Medicine of Case Western Reserve University, in Ohio, said the Mayo Clinic researchers may have come up with a “really good
The Section on Anesthesiology of The New York Academy of Medicine (NYAM) will hold its
Annual Anesthesiology Residents’ Night on Wednesday, Sept. 26, from 6:30 pm–8:00 pm, at the NYAM, 1216 Fifth Ave. at E103rd St., New York, NY (www.nyam.org). Only one submission from each training program will be considered. The paper must be original, with the resident playing a major role in the research. Papers that have been submitted to other conferences in the 2012-2013 academic year are eligible for submission. Six to eight papers will be selected to be presented at the NYAM Residents’ Night. Presenters will be expected to give an oral presentation (up to seven minutes) followed by a brief question and answer period. All selected presenters will receive a certificate recognizing their participation and a one year complimentary Associate Membership with NYAM. The resident whose presentation is judged to be the best, based on content and presentation, will be acknowledged. The resident should submit an abstract along with a completed submission form (available from dfingerhut@nyam.org) signed by the program director no later than August 26. Abstracts and admission forms may be emailed or faxed to: Donna Fingerhut Deputy Director, Office of Trustee and Fellowship Affairs The New York Academy of Medicine dfingerhut@nyam.org Fax: (212) 419-3615; Phone (212) 419-3645
Elizabeth A. M. Frost, MD Professor of Anesthesiology Mount Sinai Medical Center, New York Chair, NYAM Section on Anesthesiology
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Figure 2. Adjusted prevalence of end-stage renal disease. Source: National Institutes of Health.
idea” for the management of anesthesia in dialysis patients—an issue at most hospital centers across the country— although he stressed he would need to see their protocol and results in a full, published peer-reviewed journal article. Dr. Doyle, a member of the Anesthesiology News editorial board, noted that the work could serve as a starting point for future national guidelines
for sedation in this patient population. The guidelines are needed due to the increasing prevalence of ESRD in the United States. “It would be interesting to see their protocol in detail and have it tested at other centers to show what kind of advantages it may offer,” he said. —Brian Dunleavy
54 I AnesthesiologyNews.com
AUGUST 2013
P A IN M E D I C I NE
Patients Over 70 Do Well After Minimally Invasive Spine Surgery
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ge should not be a barrier to minimally invasive surgery for spinal stenosis, results of a new study suggest. Canadian esearchers showed that patients aged 70 and over do not have more postoperative adverse events (AEs) than, and have similar outcomes and levels of satisfaction as, younger patients, whether they have minimally invasive decompression or minimally invasive decompression plus fusion. “The decision to go ahead with the surgery depends on whether the condition is amenable to surgery and whether there is a reasonable risk from the surgery— and the ultimate decision is up to the patient,” said study leader Raja Rampersaud, MD, associate professor of orthopaedics and neurosurgery at Toronto Western Hospital and the University of Toronto, in Canada. “There should not be ageism.” Standiford Helm, MD, head of The Helm Center for Pain Management, in Laguna Hills, Calif., agreed that patients over the age of 70 are candidates for minimally invasive surgery. “It is important to apply minimally invasive surgery to the elderly, which now means the [baby] boomers because you can get so much return of function so quickly,” Dr. Helm said. Co-investigator Ilyas Aleem, MD, a senior orthopedic resident at the University of Toronto, presented a talk on the study at the Canadian Spine Society’s 2013 annual meeting. It was a post hoc analysis of data from 2008 to 2011 from the ongoing ProSTOS (Prospective Spine Treatment Outcomes Study), in
which dozens of centers across North America collect information on different spine surgeries. In the subanalysis, the investigators compared patients aged 40 to 69 with those aged 70 and over with clinically significantly degenerative lumbar spinal stenosis. The two groups had a similar percentage of women (44% and 43%, respectively) and a similar mean body mass index (28.8 and 27.8 kg/m2, respectively). However, the mean number of comorbidities was higher in the older group, at 2.5 compared with 2.1 in the younger set, and the average American Society of Anesthesiologists score was also higher (mean, 2.5 and 3 vs. 2.1 and 2, respectively).
The two groups had similar Oswestry Disability Index (ODI) scores at baseline and at one-year postsurgery, whether they underwent decompression or decompression plus fusion: At baseline, the average was just over 42 in both groups, and at 12 months it was 20.2 in the younger group and 23.9 in the older patients (P=0.30). The decompression-onlyy patients had their lowest average ODI scores at six weeks postsurgery, whereas this occurred one year after decompression plus fusion. There were seven major AEs in the under-70 group, including one case of neuropathic pain. There were five AEs in the older group, including two cases of urinary tract infection and one patient with urinary retention (P=0.67). “The most interesting data is that patients with decompression were at maximum improvement by the first data measurement period, six weeks, whereas it took the fusion patients a year to reach maximal improvement. This suggests that we should strive to decompress without destabilizing,” Dr. Helm said. Dr. Rampersaud responded, “Decompression without destabilization is always the goal in my practice. But patients with significant deformity and/or instability will typically require fusion; and when fusion is indicated, the patient needs to be appropriately educated regarding the longer recovery, regardless of age.” —Rosemary Frei, MSc Dr. Rampersaud is a consultant for Medtronic. Dr. Helm reported no relevant conflicts of interest.
Seeking Prognostic Cues During Lumbar Injections Washington—Interlaminar lumbar epidural steroid injections (LESI) are a proven method for providing shortterm relief of low back and unilateral radicular pain. But predicting how patients will respond to such treatments has not been so straightforward. But a study by a Chicago research team has found that ipsilateral pressure paresthesias occurring during LESI correlates with pain relief, and can be used as a prognostic factor when a parasagittal approach to the epidural space is used. “Lumbar epidural steroid injections are among the most commonly performed interventional pain procedures in the country,” said Nebojsa Nick Knezevic, MD, PhD, director of anesthesiology research at Advocate Illinois Masonic Medical Center. “In this study we tested ... the parasagittal approach— which means we’re going 1 cm laterally from the midline, depending on the side where the pain is.” The investigators hypothesized that a pressure paresthesia occurring in the
same distribution of the radicular pain would give prognostic information regarding the efficacy of the LESI. The investigators enrolled 100 adult patients, all of whom received LESI by either the midline (n=50) or parasagittal approach (n=50), both under fluoroscopic guidance. Patients confirmed whether or not they experienced a pressure paresthesia, and if so, whether it was in the distribution of “usual and customary pain.” Patients also graded pressure paresthesias (0 = no paresthesia; 1 = mild; 2 = moderate; 3 = severe), both ipsilaterally and contralaterally. As Dr. Knezevic reported at the 2012 annual meeting of the American Society of Anesthesiologists (abstract 202), most parasagittal patients felt pressure paresthesias as “usual and customary pain” (39 of 50). In contrast, 23 patients undergoing the midline approach gave the same response (P=0.002). With respect to severity, 32 parasagittal patients felt moderate or severe paresthesia on the ipsilateral side as
their radicular pain compared with 19 midline patients. By comparison, only five patients in the parasagittal group felt pressure paresthesia on the contralateral side and 18 in the midline group. Average pain score before injection was 5.1±2.4 at rest and 7.2±2.2 during movement in the midline group, and 4.9±2.5 at rest and 7.6±1.9 during movement in the parasagittal group. Both LESI approaches clinically and statistically significantly reduced unilateral lumbosacral radiculopathic pain compared with the basal level (both at rest and during movement), according to the researchers. The investigators found a statistically significant negative correlation between ipsilateral pressure paresthesia and both types of pain score in parasagittal patients, and with only pain at rest in midline patients. “The correlation between pain relief and pressure paresthesia was indirect when the paresthesia was on the ipsilateral side and direct when identified
on the contralateral side,” Dr. Knezevic explained. “This means that a more severe pressure paresthesia ipsilaterally and a less severe paresthesia contralaterally is related to better pain relief.” As a result, he added, the findings “could be utilized to optimize our therapeutic success in patients who get these injections for radiculopathic pain.” The association between pressure paresthesia and pain relief did not surprise David Provenzano, MD. “To me it indicates that directing the medicine toward the area of nerve compromise is important,” said Dr. Provenzano, executive director of the Institute for Pain Diagnostics and Care at Ohio Valley General Hospital, in Pittsburgh. “That’s one of the reasons why some practitioners advocate for the use of transforaminal steroid injections. The downside of the midline interlaminar approach is the medicine may never get where you want it to go.” —Michael Vlessides
AUGUST 2013
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PA IN M E D ICIN E
Loop Approach Halts Lead Migration in Spinal Cord Stim Trials
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n interventional pain physician has come up with a technique to minimize migration of leads used for spinal cord stimulation (SCS). Dubbed “Lilly’s Loop,” it involves placing an extra coil of the lead wire just under the skin. Ezra B. Riber, MD, has conducted a trial in 22 consecutive SCS trial patients, all of whom were given a Lilly’s Loop in one lead and no Lilly’s Loop in the other. After a three-day trial, 73% of the nonlooped leads had migrated compared with 22% of those with loops. Dr. Riber named his approach after his daughter. Lilly was born in 1987, the year Dr. Riber was introduced to SCS during a pain fellowship. He invented the technique in 2010 after one too many patients failed a trial of SCS because of lead migration—in this case, right after the patient walked out of the procedure room. “Most patients have traveled such a long and painful road to get to a spinal cord stimulation trial that you want to give it every chance to work,” said Dr. Riber, director of Palmetto Pain Management, Columbia, S.C. “It’s devastating for the patients and their family when a trial fails because of lead migration, because that’s the end of the road and they have to go on with their pain.” At the 2013 annual meeting of the Pain Society of the Carolinas, he described how this spurred him to try to solve this problem, which has existed since SCS was invented in the 1960s and came into widespread use in the 1980s. Others have tried to correct the problem by affixing the leads to the outside of the body, but even suturing the leads to the skin results in lead migration (see, e.g., Pain Med 2011;12:204-208). “One day I got so frustrated that I became determined to find a way to put some slack into the lead, so if the patient moves in such a way that the tissues where the leads are implanted are stretched or pulled the leads won’t move very much,” Dr. Riber recalled. “I just started playing with the leads and the wires until I hit upon a solution.” Creating Lilly’s Loop involves feeding in an additional length of lead wire under the skin once the lead is in the appropriate position. The goal is to create one or two loops without moving the lead. Then, if during the few days of the SCS trial the patient moves in such a way that the lead wire is tugged or pulled, the loops uncoil
while the lead does not move. “The advantage of a longer length of lead under the skin is the creation not only of a cushion to prevent migration, but also an extended ‘sweet spot’ for low-backk and lower-extremityy coverage,” said Dr. Riber.r This is not a perfect technique, he conceded. Some leads migrate in a cephalad or upward position, which is
rare when the Lilly’s Loop is not used. Giancarlo Barolat, MD, director of Barolat Neuroscience, in Denver, praised Dr. Riber’s approach as “simple, elegant and effective,” and not requiring any additional equipment. “The initial results seem to be very promising. Of course, a larger number of patients will be needed before final statements can be made on its true impact on leads
migration. I strongly encourage a wider utilization of this approach as well as further prospective studies.” —Rosemary Frei, MSc Dr. Riber has worked with Boston Scientific and other device companies on Lilly’s Loop. Dr. Barlolat is a consultant to Medtronic and St. Jude Medical, and a consultant to and equity owner of QiG.
Less pain. Less opioids. From the start. OFIRMEV® provides significant pain relief*1 • OFIRMEV 1 g (Q6h) + patient-controlled analgesia (PCA) morphine demonstrated significant pain relief vs placebo + PCA morphine (P<0.05 over 6 h)1 • OFIRMEV 1 g (Q6h) + PCA morphine showed greater reduction in pain intensity over 24 h (SPID24)† compared to placebo + PCA morphine (P<0.001)2
OFIRMEV reduces opioid consumption*1 • OFIRMEV 1 g (Q6h) + PCA morphine significantly reduced morphine consumption vs placebo + PCA morphine (–46% over 6 h, P<0.01; –33% over 24 h, P<0.01)1 • The clinical benefit of reduced opioid consumption was not demonstrated
OFIRMEV from the start • Consider administering the first dose of OFIRMEV PreOp or post-induction • Schedule OFIRMEV Q6h for first 24 h and continue as clinically warranted
Indication ndication OFIRMEV is indicated for the management of mild to moderate pain; the management of moderate to severe pain with adjunctive opioid analgesics; and the reduction of fever. Important Safety Information OFIRMEV is contraindicated in patients with severe hepatic impairment, severe active liver disease or with known hypersensitivity to acetaminophen or to any of the excipients in the formulation. Acetaminophen should be used with caution in patients with the following conditions: hepatic impairment or active hepatic disease, alcoholism, chronic malnutrition, severe hypovolemia, or severe renal impairment. Do not exceed the maximum recommended daily dose of acetaminophen. Administration of acetaminophen by any route in doses higher than recommended may result in hepatic injury, including the risk of severe hepatotoxicity and death.
OFIRMEV should be administered only as a 15-minute 15 minute intravenous infusion. infusion Discontinue OFIRMEV immediately if symptoms associated with allergy or hypersensitivity occur. Do not use in patients with acetaminophen allergy. The most common adverse reactions in patients treated with OFIRMEV were nausea, vomiting, headache, and insomnia in adult patients and nausea, vomiting, constipation, pruritus, agitation, and atelectasis in pediatric patients. OFIRMEV is approved for use in patients ≥2 years of age. The antipyretic effects of OFIRMEV may mask fever in patients treated for postsurgical pain. To report SUSPECTED ADVERSE REACTIONS, contact Cadence Pharmaceuticals Inc. at 1-877-647-2239 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.com. Please see Brief Summary of Prescribing Information on adjacent page or full Prescribing Information at OFIRMEV.com.
*Randomized, double-blind, placebo-controlled, single- and repeated-dose 24-h study (n=101). Patients received OFIRMEV 1 g + PCA morphine or placebo + PCA morphine the morning following total hip or knee replacement surgery. Primary endpoint: pain relief measured on a 5-point verbal scale over 6 h. Morphine rescue was administered as needed. †SPID24=sum of pain intensity differences, based on VAS score, from baseline, at 0 to 24 h.
References: 1. Sinatra RS, Jahr JS, Reynolds LW, Viscusi ER, Groudine SB, Payen-Champenois C. Efficacy and safety of single and repeated administration of 1 gram intravenous acetaminophen injection (paracetamol) for pain management after major orthopedic surgery. Anesthesiology. y 2005;102:822-831. 2. Data on file. Cadence Pharmaceuticals, Inc.
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