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Penalties for Poor Medicare Quality Reporting Start Now

tarting in 2015, the small financial incentives associated with voluntary reporting of pay-forperformance measures under Medicare will turn into potentially significant financial penalties for anesthesiologists who do not meet the new mandatory quality reporting requirements. Since 2007, the Centers for Medicare & Medicaid Services (CMS) offered physicians and other “eligible professionals”

Perioperative Surgical Home Lowers Costs, Optimizes Care New Orleans—Judging by the experience of two large hospitals, the perioperative surgical home (PSH) model of care can create substantial cost savings, an important benefit as the idea seeks to be widely adopted. The PSH model is a patient-focused multidisciplinary approach whose goal is to optimize health care value, with anesthesiologists at the head of a multidisciplinary, comprehensive care team. At the American Society of Anesthesiology’s annual meeting in New Orleans, physicians from Kaiser Permanente in California and Ochsner Health System in

see performance page 20

see home page 14

Physicians Versus CRNAs:

Redefining Roles in the Changing Landscape of Health Care Michael DeCicca, MD

labor- and cost-savingg machine that made quality clothing widely available to the public. Heathcote’s machine Anesthesiology Resident, CA-2 deftly wove threads into lace that mimicked the artistry State University of New York Upstate Medical Center of experienced lace-makers; lace-makers who, when Syracuse, New York presented with this new invention, immediately recogn 1816, textile activists attacked and destroyed 55 nized its threat to render their jobs obsolete. In response, the lace-makers and other textile artilace-makingg power looms at the Heathcote factory in Loughborough, England.1 The loom, one sans organized themselves into “Luddites,” a name of many innovative new technologies of the Indus- that has come to describe a group unwilling to adopt trial Revolution, had been introduced recently as a see Luddites? page 22

CLINICAL ANESTHESIOLOGY

Thoracic ultrasound for checking DLET positioning before one-lung ventilation.

PAIN MEDICINE

Chronic pain a widespread reality among U.S. military veterans.

CME: PREANESTHETIC ASSESSMENT

Lesson 313: Preanesthetic Assessment of the Patient With Hyperthyroidism

POLICY & MANAGEMENT

ASA past-president John Neeld Jr., issues CRNA challenge, gets results.

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Important Safety Information: 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 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 be performed 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 of developing toxic plasma concentrations. In clinical trials, the most common adverse reactions (incidence ≥10%) following EXPAREL administration were nausea, constipation, and vomiting. References: 1. Gorfine SR et al. Dis Colon Rectum. 2011;54(12):1552-1592. 2. Golf M et al. Adv Ther. r 2011;28(9):776-788.

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PRN

Pilot Study Finds Preprinted Labeling Saves Time, Ups Safety Montreal—If the experience of residents holds true for their more senior colleagues, then a pilot project at the State University of New York at Stony Brook has the potential to improve syringe labeling in more than one institution. A preprinted label system developed by residents Brian Cho, MD, and Kevin Lee, MD, received an overwhelmingly positive response from study

participants, largely due to its convenience and positive effects on efficiency. “This pilot project started during our first year in anesthesia when we realized that we had to label all our syringes in the OR [operating room],” said Dr. Cho. “We quickly found out that syringe labeling is very important. We do a lot of handoffs in a workday, and having accurate information on

our labels is important. and Lee comprised a standardized tem“Nevertheless, it seems we often miss plate of preprinted syringe labels with the writing down all the information that we following information: drug name/conneed. We will sometimes slap on a sticker centration, user initials and date/time. for whatever drug is in the syringe and The labels were created on Microsoft then go do the case. And when we take Excel; a macro allowed for quick printover a case we often see labels that are ing of customized labels for each particiinaccurate. So we thought maybe there’s pating resident. Labels were printed one a way to make things better.” day before their intended use and were The system developed by Drs. Cho available for pickk up at the OR pharmacy window on the morning of use. Surveys were distributed before and after the four-weekk pilot to gauge user feedback. “We wanted to keep the system simple and be able to distribute the labels from a centralized location,” Dr. Lee said. “We ended up using a bin at the central OR pharmacy to distribute the labels when residents went to pick up their meds.” As reported at the 2014 annual meeting of the International Anesthesia Research Society (abstract S-219), 22 and 15 residents completed the pre- and post-project surveys, respectively. Interestingly, although all respondents indicated the importance of medication syringe labeling for patient safety, only 32% said they alwayss labeled them. The overwhelming majority of residents (85%) preferred the preprinted labels to the existing ones; 78% said the preprinted labels decreased turnover time compared with the existing ones. Given these results, it is not surprising to learn that all of the residents who participated in the program thought the preprinted labels should be permanent fixtures at the institution. Dr. Lee added that the system is not limited to use in the OR. “These labels are applicable to other areas where anesthesia is practiced, such as labor and delivery, the electrophysiology lab or even in cardiology.” Yet as Benedikt Preckel, MD, pointed out, there are bigger concerns with syringe labeling if the system is to become widely adopted. “Since there is an international standard for the labeling of drugs [ISO 26825], I think you should try to follow it in these very early moments,” said the professor of anesthesiology at the Academic Medical Center of Amsterdam, the Netherlands. “Because then you have standardization that can be applied to other hospitals. “The Netherlands is a very small country, but I recently performed an audit on how we label drugs and found that everybody uses different labels for the same substances,” he added. “I think we could just as easily stick to the ISO standard, which is readily available.” —Michael Vlessides EXP-AP-0020-201301

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CLINICAL ANESTHESIOLOGY

Techniques Can Push Regional Anesthesia Risks Still Lower Toronto—The risk for neurologic injury associated with regional anesthesia is very low, but there are steps that anesthesiologists can take to further reduce that risk, according to anesthesiologists who spoke at the International Symposium of Ultrasound for Regional Anesthesia, Pain Medicine & Perioperative Applications.

“What we do is very safe, but this allows us to spend a lot of time talking about the optimal way to make things even safer,” Kyle Kirkham, MD, FRCPC, staff anesthesiologist at Toronto Western Hospital, University Health Network, and assistant professor, Department of Anesthesia, University of Toronto, Ontario, Canada, said in an interview with Anesthesiology News.

The issue of increasing proximity to the nerve without causing injury has been considered the backbone of much research into anesthesia and neurologic injury, but alternative approaches, such as maintaining distance from the nerve but still ensuring sufficient diffusion of anesthetic, should be explored. “Can we step back and find an approach that doesn’t require the needle

to be in contact with the nerve at all?” Dr. Kirkham asked. “The accuracy of ultrasound is such that it can only show you so much. We don’t know the boundaries of the nerve in many cases.” Some practices relating to current flow and twitch provide clues to avoiding nerve injury, but these guidelines are certainly not foolproof, said Paul McHardy, MD, FRCPC, an anesthesiologist at Sunnybrook Health Sciences Centre, in Toronto. “We have discovered that a lot of studies have shown you can be touching the nerve and have high current and not get a twitch,” Dr. McHardyy said. “At the same time, you can be outside the nerve, have low current and have a twitch. The architectural structure of the nerves behaves differently in terms of risk.” Using pressure as a measurement is a reliable way to minimize the risk for neurologic injury. “If there are pressures of more than 20 psi [pounds per square inch], then you know you are in a danger zone, and there is a high risk for nerve injury,” Dr. McHardyy stated. “If pressure measures less than 15 psi, then you are in a safer zone.” One animal study (Reg Anesth Pain Medd 2004;29:417-423) demonstrated that high injection pressures may suggest intraneural needle placement and result in persistent neurologic deficits, leading the authors to recommend against excessive injection pressure. Xavier Sala-Blanch, MD, an anesthesiologist and director of the Orthopedic Anesthesia Section, University of Barcelona, in Spain, pointed to retrospective research (Reg Anesth Pain Med 2013;38:289-297) that concluded ultrasound guidance can decrease the risk for local anesthetic systemic toxicity, which can be life-threatening, after peripheral nerve blockade. “It is important that we try to reduce the percentage of injury,” Dr. Sala-Blanch said. “Ultrasound helps us to do this.” Thomas Grau, MD, PhD, MA, professor and chair of the Department of Anesthesiology, Intensive Care Emergency Medicine and Pain Medicine, Klinikum Gutersloh GmbH, in Gutersloh, Germany, said communication with patients preoperatively should take place to ensure that they have consented to the type of anesthesia that is administered and they understand associated risks. “The patient has the right to discuss different modes of anesthesia,” Dr. Grau stated in an interview. —Louise Gagnon

DECEMBER 2014

AnesthesiologyNews.com I 7

CLINICAL ANESTHESIOLOGY

Low-Pressure Epidural Gravity Saline Technique May Reduce Cesarean Complications Baltimore—In patients undergoing cesarean delivery who are receiving a combined spinal epidural (CSE), a study has found that delivering epidural saline using a low-pressure gravity technique leads to fewer complications than relying solely on an epidural catheter.

The investigators Shaul Cohen, MD, Antonio Chiricolo, MD, and their colleagues from the Rutgers-Robert Wood Johnson University Hospital, in New Brunswick, N.J., tested whether giving cesarean delivery patients 10 mL of epidural saline via a low-pressure method, after the spinal and before the epidural is given, would result in fewer epidural blood vessel punctures and paresthesias and better-quality sedation than traditional CSE. For this prospective, randomized, double-blind study, 229 women having elective cesarean delivery were placed in one of two groups: those receiving epidural saline by gravity and CSE and those receiving only CSE. The study was presented at the 2014 annual meeting of the Society for Ambulatory Anesthesia (abstract 30). In CSE, the physician injects spinal solution through the spinal needle, which is traced through a larger epidural needle. The spinal needle is withdrawn while the epidural needle remains in place, although there is a risk for epidural blood vessel punctures and paresthesias. In rare cases, catheters can enter the subarachnoid space and lead to a total spinal, with loss of consciousness and respiratory arrest. “We think the saline helps by lubricating the structures in the epidural space,” said Dr. Chiricolo, thus creating a pathway that allows the catheter to advance.

Patients were randomly assigned to two groups. In the first group of 115 patients, a catheter was inserted immediately after the spinal solution, which was delivered with a Pencan needle (B. Braun Medical) through the epidural needle. In the second group of

114 patients, each patient was given 10 mL of saline by gravity after the spinal solution was injected and before a closed-end catheter (B. Braun Medical) was inserted epidurally. The investigators used a CSE kit, which contained an Espocan epidural

needle (B. Braun Medical) along with a Pencan spinal needle. The Tuohy needle in these kits has a hole at the tip that allows the spinal needle to slide through to pierce the dura. While lying on their sides, all see pressure page 8

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CLINICAL ANESTHESIOLOGY PRESSURE

After the procedure, the investigators collected patient data, asked the patients were given injections of 10 mg anesthesiologists how many attempts ropivacaine, a local anesthetic, along were required to pass the catheter, and with 100 mcg of epinephrine and 25 observed whether there was frank blood mcg of fentanyl at roughly the same in the cerebrospinal fluid or catheter. location in the spine. Additional doses The data collectors tested patients’ of local anesthesia (5-20 mL of 0.75% motor abilities using a 5-point Bromropivacaine—an isobaric solution— age test, with 1 meaning the patient with 5 mcg/mL epinephrine and 5 mcg lacked foot movement and 5 meanfentanyl) were injected into the epi- ing the patient could achieve total hip dural catheter if spinal anesthesia was and knee flexion. The highest level deemed unsatisfactory. of motor block from either leg was CONTINUED FROM PAGE 7

recorded and used in later analyses. Epidural catheters caused blood vessel punctures in 19 patients in the first group, those who received CSE alone, and in six patients in the second group, those given epidural saline and CSE. In the first group, 74 patients had paresthesia, compared with 46 patients in the second group. After their procedures, the patients were given lidocaine with epinephrine via the epidural catheter, which was connected to a portable Abbott

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

Pain Management Provider to relieve postsurgical pain. Seventeen patients in the first group required additional nitrous oxide or fentanyl for pain relief, whereas three patients in the second group needed medication for additional pain relief. Physicians were unable to pierce the dura with a spinal needle and failed to achieve spinal blocks in 17 patients in the first group and 23 patients in the second group—a failure rate of 14.8% and 20.2%, respectively. Art Saus, MD, assistant professor of anesthesiology at Louisiana State University Health Center, in Shreveport, commented that he found the failure rate to be “awfully high” for physicians using a CSE kit. “Failure to put the needle into the dura would be very uncommon.” Dr. Saus felt that although the authors reduced complications in patients undergoing cesarean delivery using the gravity technique, their methodology raised too many questions to be able to determine the study’s value. A disproportionate number of patients may have been heavy—setting a spinal block in an obese patient is typically more difficult—or perhaps less experienced residents may have been handling the epidurals, Dr. Saus said. Knowing the body weight of each patient, and whether there were equal numbers of heavy and light women in each group, would have made the data stronger, he said. Whatever the causes, the study authors lost 15% to 20% of their subjects in each group because of this high failure rate, a fact that Dr. Saus felt left the study underpowered. The patient groups showed no differences in levels of itching, sedation, hypotension, time to pain or overall satisfaction. The time to incision was nearly equal, at 32.7 minutes for the first group and 32.6 minutes for the second group. In a later phone survey, the investigators found that all of the epidurals were successful for postoperative pain management for two to three days. They found no differences in shortness of breath or muscle weakness between the groups. The authors believed their results could be easily replicated. Dr. Chiricolo said future studies might evaluate the same patient population using a hyperbaric solution for the spinal block instead of an isobaric solution, to see how results might differ. —Shannon Firth

DECEMBER 2014

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CLINICAL ANESTHESIOLOGY

Thoracic Ultrasound Alternative to Bronchoscopy For Checking Double-Lumen Endotracheal Tube Positioning Toronto—Thoracic ultrasound is a viable alternative to fiber-optic bronchoscopy for verifying the correct position of a double-lumen endotracheal tube (DLET) before one-lungg ventilation, a study has found. Andrea Saporito, MD, a consultant anesthetist at Bellinzona Regional Hospital, in Bellinzona, Switzerland, and the study’s principal investigator, noted that thoracic ultrasound is noninvasive and cheaper than fiberoptic bronchoscopy. “Fiber-optic bronchoscopy is the gold standard, but it is expensive and has to be performed by an anesthetist,” he said in an interview with Anesthesiology News. “The ultrasound does not have to be performed by an anesthetist with special skills; it can be performed by a nurse.”

The researchers concluded that both approaches were equally sensitive and specific for confirming correct left DLET positioning, with only one discordant case. The investigators conducted a case– control, crossover, blinded study in which 51 patients, with American Society of Anesthesiologists physical status 1 to 3 and a mean age of 62.6 years, were undergoing thoracic surgery using onelungg ventilation. After patient intubation with a DLET, the researchers evaluated correct lung isolation with bronchoscopy followed by thoracic ultrasound. Dr. Saporito and his colleagues presented a poster on the study at the International Symposium of Ultrasound for Regional Anesthesia, Pain Medicine & Perioperative Applications. The results were published in the Journal of Ultrasound (2013;16:195-199). The researchers concluded that both approaches were equally sensitive and specific for confirming correct left DLET positioning, with only one discordant case. They also found a significant difference in execution time between the two procedures, with ultrasound being faster than bronchoscopy (2.08 vs. 7.70 min; P<0.05). The time reduction, and the fact that a nurse could perform thoracic ultrasound,

produced a net savings of 5.2 euros per patient treated, about $7 US. The results should be confirmed with a larger sample size of patients, Dr. Saporito noted. “It’s a pilot study, and thoracic ultrasound needs to be further evaluated,” he said.

Methodology Limitations Jerome M. Klafta, MD, professor and vice-chair for education and academic affairs, Department of Anesthesia and Critical Care, University of Chicago, felt the data were not robust enough to present thoracic ultrasound

as a management option. “It’s a bit of a stretch to think that [thoracic ultrasound] would play an important role in the modern management of double-lumen tubes,” Dr. Klaftaa said in an interview. see thoracic page 16

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CLINICAL ANESTHESIOLOGY

Turbine-Driven Ventilator Offers Theoretical Option for CPR Montreal—Although most health care professionals meet advanced cardiovascular life support (ACLS) guidelines when ventilating through a selff inflatingg bag, they do so with wide ranges in various ventilatory end points, which may in turn affect systolic blood pressure. However, a new study has shown that a novel, turbinedriven ventilator meets the same

guidelines while providing greater consistency, making it an attractive option in CPR situations. “For those of us who have done CPR with a bag-valve mask, we sometimes get a bit overzealous,” said Scott Allen, MD, a resident at the University of Utah, Salt Lake City. “We have one job and we want to do it well, so we squeeze like crazy. The

‘For those of us who have done CPR with a bag-valve mask, we sometimes get a bit overzealous.’ —Scott Allen, MD

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Department of Bioengineering at the University of Utah has been developing a portable, battery-powered ventilator that runs off a turbine and doesn’t need a compressed gas source.” To test the portable ventilator’s relative adherence to ACLS guidelines, Dr. Allen and his colleagues paired 24 ACLS-certified health care practitioners into groups of two. Each team performed four randomized rounds of two-minute cycles of CPR on an intubated manikin, with individuals alternating between compressions and breaths. Two rounds of CPR were performed with a bag-valve selff inflatingg mask, and two were performed with the new portable ventilator. The ventilator was set to deliver eight breaths per minute, with a pressure limit of 22 cm H2O. The researchers measured respiratory rate, tidal volume, peak airway pressure and compression interruptions (i.e., hands-offf time). Teams also attempted to mask ventilate the extubated manikin with the ventilator and the selff inflatingg bag. As reported at the 2014 annual meeting of the International Anesthesia Research Society (abstract S-83), the mean respiratory rate with the ventilator was 8±0.1, compared with 10.1±2.2 for the selff inflatingg bag. “Although the mean respiratory rate with the selff inflatingg bag was within the guidelines, the variation was pretty wide. Some people were at 20 per minute while others were at five per minute,” Dr. Allen said. Mean tidal volume was found to be 0.482±0.022 L with the ventilator and 0.626±0.084 L with the selff inflating bag, respectively, whereas mean peak inspiratory pressure was 22.15±0.314 cm H2O and 31.88±4.47 cm H 2O, respectively (Figure). “Some people were close to 50 cm H2O and others were about 20 cm H2O.” Mean hands-offf time was greater with the selff inflatingg bag (6.41±1.45 seconds) than the ventilator (5.25±2.10 seconds). The investigators also examined the amount of air that leaked from the respective masks during nonintubated ventilation. The turbine-driven ventilator delivered 2.7 L tidal volume, of

DECEMBER 2014

AnesthesiologyNews.com I 11

CLINICAL ANESTHESIOLOGY Hopkins Hospital, in Baltimore, said he was not particularly surprised that the turbine-driven ventilator delivered near-perfect respiratory rates and tidal volumes. “The notion of a turbine mechanism to generate the volume to ventilate may be especially interesting in places where there is no—or inconsistent—compressed gases … as in austere environments,” he told Anesthesiology News.

Peak Inspiratory Pressure, cm H20

—Michael Vlessides 10

Ventilator

Self-Inflating Bag

Ventilator

Self-Inflating Bag

Lung Tidal Volume, L

0.8

0.6

0.4

0.2

Figure. Peak inspiratory pressures and tidal volumes for a turbinedriven ventilator and self-inflating bag. which 0.43 L entered the lungs. The selff inflatingg bag, on the other hand, delivered 0.45 L, of which 0.26 L entered the lungs. “So even though there was much less percentage of a mask leak with the selff inflatingg bag, the overall volume of air that got into the lungs was higher with the ventilator.” Although still being developed at the institution, this type of device may ultimately prove its utility in a number of clinical situations, Dr. Allen explained. “In a CPR situation, it will allow people—maybe in an ambulance or an emergency situation—to use this ventilator without having to squeeze the bag, thus freeing up their hands for other things.” Robert S. Greenberg, MD, associate professor of acute and critical care medicine and pediatrics at the Johns

interviews podcasts procedural videos Watch and listen at

anesthesiologynews.com/multimedia.aspx

12 I AnesthesiologyNews.com

DECEMBER 2014

CLINICAL ANESTHESIOLOGY

Vial Size of Injectable Drugs Affecting Patient Safety and Medication Shortages

he FDA drafted new recommendations regarding the fill size for vials of injectable drugs and biologic products this summer, which prompted a response from the American Society of Anesthesiologists. In a letter to FDA Commissioner

Margaret Hamburg, ASA President Jane Fitch, MD, said the anesthesiology group “strongly supports the FDA’s recommendation that a drug product’s vial fill size be appropriate for the labeled use and dosing of the product,” and proposed working with the FDA and

sponsors in implementing guidance on the issue. “Critical anesthesia drugs are still in shortage, and the availability of appropriately sized vials will help limit waste.” The FDA drafted the new recommendations out of concerns that

‘Working together, we can take significant steps to help mitigate drug shortages and protect patient safety.’ —ASA letter to the FDA

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potentially unsafe handling of injectable drugs has led to an increase in vial contamination and an increased risk for the transmission of bloodborne illnesses among patients, according to a notice in the Federal Register. ASA was one of 15 groups or individuals to comment on the guidance during an open period this spring, said FDA spokesperson Jeff Ventura. “ASA would appreciate the opportunity to work with the FDA and sponsors to implement guidance on labeled vial fill size, and in particular to identify the usual or maximum dose for a drug product,” the ASA letter said. “Physician anesthesiologists have unique knowledge of the typical doses of drug products and how they are used every day in operating room settings and pain clinics. Working together, we can take significant steps to help mitigate drug shortages and protect patient safety.” The draft guidance, intended for new drug applications, biologics license applications and new packaging supplements, said that manufacturers must follow United States Pharmacopeia standards to fill each injectable product container with a volume that slightly exceeds the label, to permit withdrawal and administration of the drugs. Deviations from the recommendations should be justified with content-testing data. Sponsors also should determine the appropriate packaging sizes during product development, considering how

DECEMBER 2014

AnesthesiologyNews.com I 13

CLINICAL ANESTHESIOLOGY vials are likely to be used. In deciding vial fill size, the FDA said manufacturers should consider the following: • Single-dose vials should not contain a significant volume beyond what would be considered a usual or maximum dose. • Health care providers should not be routinely required to use more than one vial to administer a typical single dose of the drug. • Multiple-dose vials should contain no more than 30 mL of drug. As of press time, the ASA had not received a response, said Beverly Philip, MD, the ASA’s vice president for scientific affairs and a professor of anesthesia at Harvard University, Boston. She was not concerned. “I think the FDA deserves credit for working hard to try to solve these drug shortages and the drug safety issues,” Dr. Philip said. “Within their regulatory limits, they are working with the medical professional organizations and the pharmacy organizations to make progress on these.” Two categories of anesthetic drugs have been problematic regarding vial size, Dr. Philip told Anesthesiology News. One is propofol, generally packaged in vials of at least 20 mL. Physician anesthesiologists may need just a small 5- or 10-mL dose to provide brief anesthesia to insert a block, she said. Additionally, if there are only a few minutes left on a longer procedure and one vial of propofol has been used up, the physician anesthesiologist may need to open a second vial just to use a small percentage of it. At larger hospitals like hers, leftovers can be repackaged by the pharmacy under a sterile hood in a sterile room. But “that may not be an option for smaller facilities,” she said, who might have to waste the remainder. “Having small-viall flexibility will help make sure that anyone who uses propofol will use it as cleanly as possible.” The other category is pain medicine: Physician-anesthesiologists may need just a few milliliters of contrast material to inject local anesthetic under xx ray guidance, but vials contain much more. Mr. Ventura said the FDA could not discuss the guidance as it is being reviewed and edited, “nor can we estimate when said review will be completed.” Dr. Philip said that’s a fair comment: “I have every expectation that the ongoing positive dialogue between ASA and the FDA is going to continue. We are really both on the same side of this issue, and they’ve been very interested in making it work.” —Karen Blum

NSAIDs May Increase Risk for Venous Thromboembolism

eople who use nonsteroidal antiinflammatory drugs (NSAIDs) have a statistically significantly increased risk for venous thromboembolism (VTE), according to a new study. A team of researchers conducted a systematic review and meta-analysis of one cohort study and five case–control studies to examine the association between NSAID use and VTE. They found a 1.8fold increase for VTE among NSAID users

(95% confidence interval, 1.28-2.52). The “Physicians should be aware of this assostudy included 21,401 VTE events. ciation and NSAIDs should be prescribed “Our results show a statistically signifwith caution, especially in patients already icant increased VTE risk among NSAID at a higher risk of VTE.” users. Why NSAIDs may increase the risk The researchers noted limitations to of VTE is unclear. It is possibly related to this study, including evaluating all NSAIDs COX-2 [cyclooxygenase-2] inhibition leadas a group and the finding that not all ing to thromboxane–prostacyclin imbalNSAIDs may increase the risk for VTE. ance,” lead author Patompong Ungprasert, The findings were published online MD, at Bassett Medical Center, in CooSept. 24 in Rheumatology. y perstown, N.Y., said in a press release. —Martin Leung

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DECEMBER 2014

CLINICAL ANESTHESIOLOGY HOME

CONTINUED FROM PAGE 1

Louisiana, reported that PSHs have reduced hospital lengths of stay (LOS), kept patients out of skilled nursing facilities (SNFs) and reduced the costs associated with care. The transition from a system of volume-based reimbursement to one that is value-based has created both uncertainty as well as new opportunities for the specialty of anesthesiology, according to Chunyuan Qiu, MD,

of Kaiser Permanente’s Baldwin Park Medical Center. “As a result, reengineering the perioperative processes is not only an imperative for the present, but also a necessity for the future of anesthesiology,” he said. The PSH provides “broader, deeper care” to patients and conveys “tremendous financial and professional rewards,” Dr. Qiu said. He calculated his hospital saved more than $1 million by caring for 516 patients in the PSH model compared with a traditional model.

“In our view, anesthesia practice Table. Outcomes for PSH vs. Fast-Track needs to go beyond the operating Outcome PSH (N=518) room. The PSH allows us to practice Spinal anesthesia, % 74.3 the 2.0 version of anesthesia,” he said in his presentation, which earned a Nerve block rate, % 99.9 Best Clinical Abstract distinction. 1.9 Dr. Qiu’s co-investigator, Naren- Mean hospital LOS, d dra S. Trivedi, MD, who described the All pain scores <4, % 64 Kaiser Permanente model at another POD 0 physical therapy, % 78.7 session, said that although the PSH involves slightly more work for anes- POD 1 home discharge, % 43.1 thesiologists and less for surgeons, the 30-d readmission, % 1.2 gain to anesthesiology is clear. “We SNF bypass rate, %

LOS, length of stay; NS, not significant; POD, postoperative day; PSH, S , pe p ope perioperative p at e su surgical g ca home; o e; SNF, S , sskilled ed nursing u s g facility ac tyy

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are getting out of our small silo of the OR [operating room] to become entire perioperative physicians. The hospital is happy—it is getting results, saving money. Patients are happy. We have enlarged our scope of practice and this makes us happy. Surgeons work less, so they are happy. There’s no losing here.” The aims of the PSH include medical optimization of the patient before surgery, intraoperative anesthetic management and postoperative facilitation of functional recovery after discharge— all coordinated by anesthesiologists. “Traditional patient care is sequential, decentralized and has a lot of gaps. PSH is patient-centered, multidisciplinary and anesthesia-linked, with functional recovery as a part of it,” Dr. Qiu explained. “It means we are not just looking at nausea and vomiting, or morbidity. We are providing a blueprint for our patients to be healthier as a result of better overall functioning.”

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Kaiser Permanente Model: Total Knee Arthroplasty At Baldwin Park Medical Center, medical optimization begins at the first appointment with the anesthesiologist, three to 14 days before the scheduled total knee arthroplasty. High-risk patients have a joint consultation with an anesthesiologist and internist in a single appointment. The specialists then formulate a coordinated plan for perioperative care. Dr. Qiu and his colleagues compared outcomes between 518 patients treated over eight months using the PSH care model and 546 patients cared for under the hospital’s traditional fast-trackk model during the previous year. They found the PSH group had shorter LOS, fewer SNF admissions and lower costs of care, with no compromise in patient satisfaction or quality of care (Table).

DECEMBER 2014

AnesthesiologyNews.com I 15

CLINICAL ANESTHESIOLOGY

Fast-Track (N=546)

P Value

43.7

<0.05

50.1

<0.05

3.2

<0.05

0.9

<0.05

The improvements above and beyond “what were already very good outcomes,” according to Dr. Qiu, resulted in substantial cost savings. There were 72 fewer SNF admissions (279 fewer than the national average). Hospital LOS was reduced by 673 days (by 1,088 days vs. the national average). The hospital’s potential cost savings (by 2014 fee schedules) for these 518 patients was $1,1912,538. “Any company looking at this number would support the concept of having anesthesiologists manage perioperative care,” Dr. Trivedi said. Based on these results, Kaiser Permanente will consider implementing the PSH in other hospitals, he said. Ochsner Health System Model: Total Hip Replacement For its pilot PSH program, Ochsner Hospital chose patients having primary total hip arthroplasty (THA), an area with room for improvement, said David Broussard, MD, vice chair of anesthesiology. In 2013, a patient’s average LOS for a THA was 3.5 days, but with the PSH, instituted in March 2014, this dropped to 2.1 days. “This is more than a full day less, which creates more capacity in the hospital, decreases the patient’s risks related to hospitalization and reduces cost of care,” Dr. Broussard said in an interview. With an anesthesiologist coordinating care, the patient is assessed preoperatively for frailty and risk for complications using a comprehensive triage process. An anesthesiologist coordinates the preoperative workup and ensures the patient is medically optimized, focusing on identifying and remediating risk, educating patients and decreasing unnecessary testing. “Prehabilitation,” nutritional counseling, correction of anemia and other interventions are employed as needed,

according to Matthew E. Patterson, MD, who presented the study at the late-breakingg abstract session. The intraoperative and postoperative processes were standardized, and included the following: • For surgery, combined spinal epidural is the anesthetic of choice unless contraindicated. IV fluid is standardized to minimize risk for postoperative acute renal injury. • Postoperatively, the anesthesiologist makes rounds daily to medically

patients transitioned to a SNF and manage and coordinate postoperative care; the goal is “rapid deonly 5% were capable of home selff escalation of care.” care. Today, only 17% go to SNF and • Epidural analgesia is discontinued 14% manage home selff care. The averthe morning of postoperative day 1. age Harris Hip Score, a measure of • Physical therapy is initiated on the outcome, was 94%. The decrease in day of surgery in the recovery room, hospital LOS resulted in increased hosthen twice daily. pital bed capacity, which accrued an • Low-frailtyy patients who perform additional $201,931 income per year, well in physical therapy are eligible Dr. Patterson reported. Furthermore, Ochsner is the first for discharge on postoperative day 1. The pilot met its milestones. Before hospital to have the Anesthesia Quality the PSH was implemented, 27% of see home page 16

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

How to get started: To learn more about the areas of interest for anesthesia and requirements for submission visit http://engagezone.merck.com/anesthesia.html. There are two review cycles for anesthesia submissions:

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16 I AnesthesiologyNews.com

DECEMBER 2014

CLINICAL ANESTHESIOLOGY THORACIC

CONTINUED FROM PAGE 9

Dr. Klafta noted that the investigators failed to mention the method used for placing the double-lumen tubes. “If you want to talk about how effective your method is for confirming placement [of tubes], you also have to mention what your method of placement is,” he pointed out. The results section of the study did not mention the percentage of tubes that were successfully placed, he noted.

HOME

“If, in fact, there were a significant number that were malpositioned, then it would necessarily require the bronchoscope to achieve successful placement,” said Dr. Klafta, adding that the medical literature supports up to 30% of tubes that are placed without a bronchoscope being suboptimally positioned when placement is verified with a bronchoscope. Although the authors of the study regard fiber-optic bronchoscopy as a rescue technique, Dr. Klafta said the

data supported a limited clinical utility of thoracic ultrasound. “If you still need to use the bronchoscope in a significant number of patients, the utility of thoracic ultrasound is less impressive,” Dr. Klaftaa said. The weight or body mass index of patients is also information that was absent in the study, Dr. Klafta noted. “Ultrasonographic examinations are more difficult in patients who are obese. Like with cardiac ultrasound, heavier patients make it a more

technically difficult examination.” The investigators also did not consider the use of bronchial blockers for lung separation, Dr. Klaftaa said. Several studies in the literature have described how double-lumen tubes and bronchial blockers move intraoperatively, he said. “There is a need, intraoperatively, to re-establish or reassess their position in the patient, which can only be done with a bronchoscope.” —Louise Gagnon

CONTINUED FROM PAGE 15

Contact

The Cosmopolitan of Las Vegas Topics Featured at the 2015 Advanced Institute for Anesthesia Practice Management As a busy professional you realize it’s imperative to keep informed on the latest topics of interest to Anesthesiologists, Practice Administrators, CRNAs and others in the anesthesia marketplace.

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the editor of Anesthesiology News

jprudden@ mcmahonmed.com

April 17-19, 2015

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Need for More Evaluation Michael J. Avram, PhD, who moderated the Best Clinical Abstracts session, commented on the studies for Anesthesiology News. Dr. Avram, of Northwestern University Feinberg School of Medicine, in Chicago, is executive editor of Anesthesiology. “There is a need and a movement to redefine the specialty of anesthesiology in terms of the PSH. In creating this movement, I think there is also a need for top-drawer research evaluating this model and comparing it with our present models of care,” he said. “We need this so that we can say whether or not PSH really has a positive impact on patient care as well as economics, and therefore is an advantage, not just to anesthesiology—in terms of a new practice paradigm—but also in terms of outcomes for the patient.” —Caroline Helwick

Institute’s survey on Patient Satisfaction and Experience with Anesthesia incorporated into its electronic medical records. In that survey, 95% of PSH patients gave their experience the highest satisfaction rating. “Our PSH model achieved the triple aim of providing high-quality patient care and high patient satisfaction while reducing overall cost of care,” Dr. Patterson reported.

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The Advanced Institute for Anesthesia Practice Management, to be held April 17-19, 2015 at The Cosmopolitan of Las Vegas, offers a chance to experience the following topics, led by industry-renown experts. The Value of Leadership During Change Is Your Anesthesia Group a Business or Club? Coding and Billing for Postoperative Pain Doesn’t Have to Hurt The Rapidly Changing Anesthesia Landscape Getting Anesthesia Providers On Board With Compliance Impact of the 2015 CPT/ICD-10 Protecting Your Patient Data Staying On the Right Side of Compliance The Anesthesiologist’s Role in the Perioperative Surgical Home 2015 PQRS for Pain Management The AIAPM conference also includes numerous talks on anesthesia and pain billing and coding, charge capture and compliance. Please join us for an informative meeting and exceptional educational experience.

DECEMBER 2014

AnesthesiologyNews.com I 17

CORRESPONDENCE In response to â&#x20AC;&#x153;Games of the Clothes-Minded,â&#x20AC;? October 2014 issue, page 1:

Letter to the Editor

s health care providers, we have an ethical responsibility to minimize potential risks to patients and provide care that keeps them safe. Health care providers cannot practice with the premise of â&#x20AC;&#x153;that is how I have always done it.â&#x20AC;? Practice must be based on evidence. The Association of periOperative

Registered Nurses (AORN) has just completed a systematic review of the literature on the topic of surgical attire and head coverings, and collectively the evidence supports the recommendation to completely cover the hair, minimize patient exposure to health care workersâ&#x20AC;&#x2122; (HCWs) skin and wear a mask in the perioperative setting. Patient harm has occurred and surgical site infections continue on a regular basis. There is no way to determine if a surgical site infection was caused by an exposure to the

health care workerâ&#x20AC;&#x2122;s skin or hair, but we know that it can potentially cause an infection. In a classic quasi-experimental study conducted by Summers et al, the researchers cultured the hair of HCWs, inpatients and outpatients, and found bacteria in the hair of all test participants.1 Staphylococcus aureus was the most common pathogen isolated. The researchers concluded that the exposed hair of HCWs was a potential source of patient infection. They recommended that HCWs cover all hair during even

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minor surgical procedures. Dineen and Drusin investigated two outbreaks of postoperative wound infections and found that the infections were directly related to personnel carrying S. aureus in their hair.2 Wright et al reported three cases of postoperative Gordonia bronchialis sternal infections after coronary artery bypass graft surgery.3 G. bronchialis was isolated from the scrub attire, axilla, hands and a purse of a nurse anesthetist, and was implicated as the cause of the surgical site infections. Cultures taken from her roommate, who was a nurse, showed the same microorganism. After being informed of the culture results, the nurse anesthetist discarded her frontloadingg washing machine. The authors had concluded that the home washing machine was the likely bacterial reservoir. Home laundering may not reliably kill all pathogens, and the pathogens may survive in the form of biofilms in the washing machine. Therefore, it is up to us as health care providers to be diligent at minimizing patient risk. The AORN â&#x20AC;&#x153;Recommended Practices for Surgical Attireâ&#x20AC;? is based on the evidence that is available. Researchers have not conducted randomized controlled trials on attire or head coverings because it would be unethical to do so, potentially putting patients at risk. Thus, practice must be based on the evidence that we have and not personal opinion, choices or tradition. AORNâ&#x20AC;&#x2122;s recommended practices are reviewed and accepted by the National Guideline Clearinghouse and follow the standards of guideline development set forth by the Institute of Medicine. AORNâ&#x20AC;&#x2122;s recommended practices are used by the Centers for Medicare & Medicaid Services and other accrediting bodies. Facilities may be cited if the practices are not followed. As health care reform continues to evolve, quality and value will be expected at every facility, and it is imperative that we practice based on the evidence and not how we have always done it. Lisa Spruce, RN, DNP, ACNS, ACNP, ANP, CNOR, CNS-CP Director of Evidence-Based Perioperative Practice Association of periOperative Registered Nurses

References 1. Summers MM, Lynch PF, Black T. Hair as a reservoir of staphylococci. J Clin Path. 1965;18:13-15. 2. Dineen P, Drusin L. Epidemics of postoperative wound infections associated with hair carriers. Lancet.t 1973;2:1157-1159. 3. Wright SN, Gerry JS, Busowski MT, et al. Gordonia bronchialis sternal wound infection in 3 patients following open heart surgery: intraoperative transmission from a healthcare worker. Infect Control Hosp Epidemiol. 2012;33:1238-1241.

18 I AnesthesiologyNews.com

DECEMBER 2014

PAIN MEDICINE

Widespread Chronic Pain Seen in Study of U.S. Military

ith the country at war on two fronts for most of the 21st century, it should come as no surprise that chronic pain, and the treatment of it, is a significant concern within the U.S. military. A study published in JAMA Internal Medicine (2014;174:1400-1401) sought to gain unprecedented understanding of the scope of the chronic pain problem, and the consequences of its management, within the armed services by surveying more than 2,500 combat personnel who had served in either Iraq or Afghanistan in 2011. The goal was to discover the prevalence of chronic pain in this population, and to get a sense of the use of opioids (both appropriate and inappropriate). According to lead author Robin L. Toblin, PhD, clinical research psychologist at the Walter Reed Army Institute, Bethesda, Md., the potential for abuse and misuse associated with opioids was a primary consideration in the design of the study. The use of opioids in the treatment of chronic pain within the civilian population was a focus of Dr. Toblin’s work during her time at the Centers for Disease Control and Prevention (CDC), where she served as an Epidemic Intelligence Service officer before joining Walter Reed. She acknowledged that given the combination of physical injuries and Advertisement General Anesthesia Products from Cardinal Health

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psychiatric issues (e.g., post-traumatic stress disorder) many of these soldiers face as a result of their service, proper use of opioid therapy is particularly crucial. “I had conducted a similar study at [the] CDC because we felt that it was important to understand [the] use of opioids to get a greater context for misuse and abuse,” she said in an interview. “When I began my current position, we sought to look at the same constructs within a military population, who seemed to be that much more likely to be in pain due to the combat deployments over the last decade.” Of the 2,597 soldiers surveyed by Dr. Toblin and her colleagues, 45.4% reported suffering from combat injuries, and 44% reported experiencing chronic pain. Of this latter group, 48.3% reported pain lasting at least a year and 55.6% stated that they suffered from “constant” pain; 51.2% reported that their pain was moderate to severe. Although these numbers are hardly surprising for a population of soldiers serving on the front lines, the findings regarding the use of opioids within the sample are, at least on the surface, somewhat alarming. Overall, 15.1% of the soldiers surveyed said they received opioid-based therapy to manage their chronic pain; among these respondents, 23.2% said they had used opioids in the month before being surveyed, an indication that many of them were using these drugs long term. (Long-term opioid use is not recommended under the current U.S. military guidelines for pain management.) “[Based on these findings], we hope that the military services will be more aware of the unmet needs for the assessment, management and treatment of pain and will broaden the services and availability of those services for servicemembers,” Dr. Toblin said. As compelling as this data is, however, pain specialist Lynn Webster, MD, cautioned that opioid use among military personnel is not necessarily generalizable to the civilian population. “The culture in the military is much different,” said Dr. Webster, vice president of scientific affairs, PRA International in Raleigh, N.C., and immediate past president of the American Academy

‘I think it does suggest that opioids may be used in the military as a first-line therapy; alternatively, the soldiers could be using opioids to medicate other comorbid conditions. If true, it would be disturbing and could explain why the military is experiencing a crisis with prescription drug abuse.’ —Lynn Webster, MD

of Pain Medicine. Dr. Webster was not involved in Dr. Toblin’s research. “But, I think it does suggest that opioids may be used in the military as a first-line therapy; alternatively, the soldiers could be using opioids to medicate other comorbid conditions. If true, it would be disturbing and could explain why the military is experiencing a crisis with prescription drug abuse.” In a commentary published with Dr. Toblin’s research, Wayne B. Jonas, MD, Lt. Col. (Ret.) of the Samueli Institute, Alexandria, Va., and Eric B. Schoomaker, MD, PhD, Lt. Gen. (Ret.) of the Uniformed Services University of the Health Sciences, Bethesda, wrote that “the nation’s defense rests on the comprehensive fitness of its service members—mind, body and spirit. Chronic pain and use of opioids carry the risk of functional impairment of America’s fighting force” ((JAMA Intern Med 2014;174:1402-1403). For those concerned about the overall issue of opioid abuse and misuse, those may indeed be fighting words. —Brian Dunleavy

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20 I AnesthesiologyNews.com

DECEMBER 2014

POLICY & MANAGEMENT PERFORMANCE 1 CONTINUED FROM PAGE

(including nurse anesthetists) annual bonuses of up to 2% of their total estimated allowable charges for their Medicare Part B billings if they voluntarily reported on at least three quality measures, such as prevention of catheter-related infections or timely administration of prophylactic parenteral antibiotics. The intention was to help transform Medicare from “a passive player to an active purchaser of

higher quality, more efficient health care,” according to CMS. These bonuses declined from a high of 2% for program years 2009 and 2010 to 0.5% for 2012 to 2014. Now called the Physician Quality Reporting System (PQRS), the program will impose a 1.5% “payment adjustment” or penalty on Medicare charges on physicians and others who did not report on at least three quality measures during the 2013 program year. The penalty will increase to 2% in 2016 for program year 2014,

which is also the last year for PQRS bonuses. (CMS pays bonuses in the calendar year immediately following each program year but will assess penalties two years afterward.) “We are already in this even though most physicians don’t recognize it,” said Richard P. Dutton, MD, MBA, chief quality officer of the American Society of Anesthesiologists (ASA) and executive director of the Anesthesia Quality Institute (AQI). “About 61% of anesthesiologists reported

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ASA’s Anesthesia Quality Institute Increases Patient Safety

he AQI was established by the ASA in 2008, as a separate but affiliated nonprofit organization to “facilitate practice-based quality management through education and quality data feedback.” Since becoming operational in 2009, AQI has established nine clinical data registries, with more in the works. “The goals of all these initiatives are to increase patient safety,” Dr. Dutton said. “Our vision is to become the primary source for quality improvement in the clinical practice of anesthesiology.” Existing registries include the Anesthesia Incident Reporting System, which has data on more than 1,200 serious adverse events, unsafe conditions and near misses; the National Pain Registry, which includes clinical information taken directly from billing systems and electronic health records; the Anesthesia Closed Claims Project; the Perioperative Visual Loss Registry; the Anesthesia Awareness Registry; the Neurologic Injury after Non-Supine

PQRS measures in 2013, and that means 39% have to figure this out or start getting their pay docked by Medicare. Everybody needs to be prepared for the pay-for-performance universe. It’s not sufficient to provide care and bill for it; anesthesiologists have to demonstrate that they are providing good quality care.”

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your patients. Seeking a solution to replace the Hospira® LTA™ 360 Kit? Consider using the LMA® MADgic® Device for your anesthesia needs. A versatile choice to administer medica ation n across the e entire up ppe per ai airw r ay rw y and d bey eyon o d on the vocal cords, the LMA® MADgic® De evice fr f om Telefl flex is ideal fo for alll of o you ourr di d ffi fficu ficu ult and n awake intubations, bronchoscopies, tra ranseso opha h geal ecchoccardiog gra rams ms and end n os osco c pi co p es es. ation and d ex exac a t With the LMA® MADgic® Device you can selecct the type of medica dosing desired. And with its malleab ble stylet, you can atttain n precisse deliive ery tha h t’s specific to your patient’s anatomy. y to help you to deliver The LMA® MADgic® Device is ready LMA

targeted, thorough topical anesthe etic for your difffi ficcult intub batio on and extubation cases. For more in nformation contact ct your Teleflex representative or visit LM MAMADgic.com.

*For use with drugs approved for oropharyngeal delivery. Hospira and LTA are trademarks or registered trademarks off Hospira, Inc. Teleflex, LMA, MAD and MADgic are trademarks or registerred trademarks of Teleflex In ncorporated or its affiliates. © 2014 Teleflex Incorporated. All rights reserved. MC-0007 742

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Some Carrots and Some Sticks Medicare payments typically constitute about one-third of anesthesiology billings. As a result, the 0.5% annual PQRS incentive represented only a few thousand dollars for most anesthesiologists seeing Medicare patients. But these small carrots will begin turning into big sticks thanks to the Value Modifier (VM) system, a newer program that overlaps with and expands on PQRS. “If you combine these two programs together over the next five years, by 2020 the amount of money at risk through performance reporting will be about 10% of your billing, or tens of thousands of dollars,” Dr. Dutton said. The VM program is part of CMS’s value-basedd purchasing initiative, which is intended to help Medicare transition from fee-for-service to paying for quality-based care. In order to receive bonuses and/or avoid penalties, PQRS requires reporting on at least three out of about 300 measures endorsed by the National Quality Forum, which is a not-for-profit organization that “leads national collaboration to improve health and health care quality through measurement.” However, the VM program will require reporting on nine

DECEMBER 2014

AnesthesiologyNews.com I 21

POLICY & MANAGEMENT Shoulder Surgery Registry; and the recently opened Obstructive Sleep Apnea Death and Near Miss Registry. Perhaps the most notable of AQI’s registries is NACOR. Launched in 2010 with only six participating practices, NACOR now contains more than 20 million cases from more than 15,000 anesthesiologists at 2,000 facilities in 44 states—with about 2.5 million cases added quarterly. “With the current changes in regulatory requirements and the demands of non-federal payors, registry participation is becoming less of an option and more of a need,” Dr. Dutton noted. AQI is working on a Maternal Quality Improvement Project and a Global Outcomes Registry, and is collaborating with the American Congress of Obstetricians and Gynecologists to build a new registry. “It’s exciting because it’s two different specialties plus hospitals working together,” Dr. Dutton said. “We are building the clinical documentation so it will be easy for doctors and nurses to roll data into the registry at the back end, so we get very precise data at very low cost.”

(QCDR), through which individual and physician groups can submit performance reports to avoid penalties and be eligible for bonuses. An important QCDR for anesthesiologists is the National Anesthesia Clinical Outcomes Registry (NACOR), which was certified by CMS in April 2014. It gives anesthesiologists and nurse anesthetists 19 measures to report for their PQRS and VM requirements: eight existing PQRS measures (such as documentation of current medications

and pain brought under control within 48 hours) and 11 new, non-PQRS measures (such as using a checklist for postanesthesiaa transfer of care, perioperative cardiac arrest rate and other outcome measurements). See www.aqihq.org/ PQRSOverview.aspx for information. ASA members can submit their data to NACOR free of charge, but nurse anesthetists and non-ASA members must pay a fee of about $500 to participate. At the end of each year, the registry will report performance data to

Medicare in a single file. AQI piloted the service with a few practices in 2014 in order to work out coding and other technical issues. “It will be as painful a process as any government exercise is, so groups will have to put some effort into collecting the right data and getting it reported to their billing company for submission to NACOR,” Dr. Dutton said. “Hopefully, it becomes straightforward, but we’re all still learning.” —Ted Agres

—T. A.

measures, at least one of which must be an outcomes measure. Starting in 2016, CMS will evaluate 2014 performance and impose penalties on physicians in groups of 10 or more who did not report their performance. Those who report on three measures will be neither penalized nor rewarded, while those who report on nine measures will be eligible for bonuses under a complex formula that extracts money from those who do not report successfully. “The short message is if you can’t figure out pay-for-performance, you will be paying for other people’s performance,” Dr. Dutton said. Various Ways To Report Because other public and private payors often adopt Medicare’s policies, it may be only a matter of time before Medicaid and private insurance companies begin requiring anesthesiologists and other clinicians to report quality metrics. However, most anesthesiologists and clinicians may find it extremely hard to report on nine measures. “Three hundred sounds like a lot, but there are lots of medical specialties and lots of things that doctors do, so for anesthesiology we really had only three or four measures that applied to most providers,” Dr. Dutton said. Recognizing that medical specialties have unique procedures and measures— and to push reporting and record keeping down to the provider level—CMS has allowed specialty organizations to formulate additional quality measures in exchange for establishing their own Qualified Clinical Data Registry

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REFERENCE 1 Kus, et al. A Comparison of the EZ-Blocker with a Cohen Flex-Tip Blocker for One-Lung Ventilation. Journal of Cardiothoracic and Vascular Anesthesia. 2013; August 19: ISSN 1532-8422.

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22 I AnesthesiologyNews.com

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COMMENTARY LUDDITES?

CONTINUED FROM PAGE 1

new innovations or technologies.2 The less-skilled laborers who were hired to work the power looms and spinning frames could never replace the expertise and craftsmanship of a true weaver, they argued. But despite the Luddite resistance, these cost-effective alternatives proliferated. Today, every one of us owns and regularly wears clothing produced by power looms. Nevertheless, the Luddite’s selff substantiatingg claim—that, although it may do essentially the same job for cheaper, a power loom isn’t capable of producing goods of the same quality as an expert, practiced artisan—is as valid today as it was in 1816. Unfortunately, this claim doesn’t make a closet full of carefully handcrafted garments any more financially realistic for the average American. By now, you may have suspected an allegorical lesson in the above story. One might loosely draw comparisons between the skilled artisan and the board-certified anesthesiologist, while likening the loom operator to the certified registered nurse anesthetist (CRNA). The main take-away, y however, is the inevitability of change. The more practical, cost-savingg measure was ultimately adopted and eventually found widespread acceptance. Unlike the textile protestors, physicians are not made obsolete; however, their historical monopoly on primary health care is economically at odds with recent legislation. Buzzwords publicizing “up to 10 million newly insured Americans” sound impressive in a vague statistical sense, but the practical aspects of these new demands on our health care system will manifest in many costsavingg ways, including increased use of physician extenders such as nurse practitioners, physician assistants, and of course, CRNAs.3 While the hope is that future community health programs and comprehensive preventative care will decrease the need for all types of surgeries, logically the number of ambulatory, diagnostic and less-invasive cases for the newly insured will increase at a greater rate over time than the complex, open, marathon cases reserved for the very ill. These simpler cases fall well within the ability of CRNAs, who currently outnumber anesthesiologists by 17%, according to May 2013 figures from the U.S. Bureau of Labor Statistics.4,5 Currently, the majority of states require CRNAs to be directly supervised by an anesthesiologist. As of 2012, 17 states—including California,

Washington and Wisconsin—allow CRNAs to work autonomously.6 Whether CRNAs will ultimately achieve their goal of working independently of doctors on a national level remains to be seen. It’s a highly contentious debate in anesthesia: There are countless op-eds, interviews and online forums discussing the question of whether anesthesiologists or CRNAs are the better provider choice. The problem is that measuring “better” is highly susceptible to bias. When

looking at indisputable facts, training is what makes phyunsupervised CRNAs opersicians more qualified to ate at a lower up-front cost manage the care of complex disease states and special to the health care system. So, how do we anesthesipopulations, such as cardiac, ologists remain competitive pediatric or chronic pain in a market where a cheaper patients. Similar to interalternative is available? The Michael DeCicca, MD nists, anesthesiologists will answer is obvious: We must find that specializing, be it highlight the value of our unique exper- with a fellowship or research, provides tise. Any anesthesiologist will attest to a more secure career path. In light of the rigor and intensity of his or her res- dwindling reimbursements and aggresidency program. This comprehensive sive cost cutting, anesthesiologists will

Experience the power of predictable control 1- 4

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

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

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

ULT-2014-0052

DECEMBER 2014

AnesthesiologyNews.com I 23

COMMENTARY no longer remain solvent with average achievement. We need to set ourselves apart as the authority in anesthesia medicine, through specialized knowledge and strong leadership. Residency is the perfect time to cultivate our role as authorities. During these short years, we view established standards of care and health care models from an outsider’s perspective. Take advantage of this. Collaborate with friends in technology and engineering to work toward that time- or energyy saving

idea you had. Keep up with journals. The next time you ask a question and nobody has the answer, investigate it with a research project. Involve yourself in your state’s political organization to strengthen your legislative voice. If adding extra responsibilities on top of long work days and study sessions seems overwhelming, seek out faculty and fellow residents for support—before the convenience of achieving “just enough” makes it difficult to compete in increasingly demanding job markets.

Historically, the typical career trajectory for a newly graduated anesthesiologist involved bedside care of patients undergoing surgery. However, with the spread of CRNAs as independent bedside anesthetists, our role is now expanding into new career possibilities. Now we may consider research, health technology, business and administrative positions as potential alternatives to intraoperative patient management. These secondary positions will never replace the anesthesiologist’s primary

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

Rapid response†1

Early post-op neurological assessment‡3,4

Rapid recovery‡1

No accumulation1

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

October 2014

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

function as the dispenser of anesthetics, but they do offer viable alternatives to the traditional clinical function. Roles such as medical director of an ambulatory surgery center, perioperative care coordinator in a surgical care home, or clinical researcher for a pharmaceutical company or the FDA are options that, if appealing, residents should seek to gain experience in as early as possible. Making value judgments—good or bad—about CRNAs as a group is as see Luddites? page 24

24 I AnesthesiologyNews.com

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COMMENTARY LUDDITES?

CONTINUED FROM PAGE 23

useful as a Luddite throwing rocks at a loom. Instead, consider the reasons you went into anesthesia in the first place, the facets of the specialty that piqued your interest, and develop them. By harnessing our collective ingenuity, we can continue to validate our role as the authority in anesthesia. The passivity of past practitioners is no longer an option; anesthesiologists will need to actively contribute so that, as the field evolves, we evolve

ULTIVA® for Injection

with it—in a way that protects the integrity of anesthesia medicine. References 1. John Heathcoat. Encyclopædia Britannica Online. www.britannica.com/EBchecked/topic/258811/JohnHeathcoat. Accessed June 10, 2014. 2. Conniff R. What the Luddites really fought against. The Smithsonian. www.smithsonianmag.com/history/what-the-luddites-really-fought-against-264412/. March 2011. Accessed June 18, 2014. 3. Fox M. Obamacare helped up to 10 million get insurance, Gallup finds. NBC. C April 16, 2004. www.nbcnews.com/health/health-care/

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

obamacare-helped-10-million-get-insurance-gallupfinds-n78446. Accessed June 10, 2014. 4. Occupational Employment and Wages, May 2013: 29-1151 Nurse Anesthetists. U.S. Bureau of Labor Statistics. www.bls.gov/oes/current/oes291151.htm. Accessed June 9, 2014. 5. Occupational Employment and Wages, May 2013: 29-1061 Anesthesiologists. U.S. Bureau of Labor Statistics. www.bls.gov/oes/current/oes291061.htm. Accessed June 9, 2014. 6. Waknine Y. California nurse anesthetists allowed to work solo. Medscape. June 29, 2012. www.medscape.com/viewarticle/766667#1. Accessed June 10, 2014.

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

ULTIVA (n=921)

Alfentanil/ Fentanyl (n=466)

Postoperative Analgesia ULTIVA (n=281)

Morphine (n=98)

After Discontinuation ULTIVA (n=929)

Alfentanil/ Fentanyl (n=466)

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

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

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

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

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

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

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

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

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

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

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

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

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

Pain-Caused Sleep Disruption May Slow Patient Recovery

oor sleep caused by pain after surgery can prolong a patient’s hospital length of stay, a new study has found. Not exactly earth-shattering news, but now there are data to prove it. Researchers at Henry Ford Hospital, in Detroit, wanted to identify the amount of sleep disruption that occurs in the postoperative inpatient hospital setting, as well as examine sleep disruption caused by pain. They found that patients who reported poor sleep while recovering in the hospital had higher pain scores. “Our results show that increased pain scores result in decreased sleep duration,” said lead author Anya Miller, MD, with the Department of Otolaryngology-Head & Neck Surgery, in a press release. “So, better pain control could potentially improve sleep duration for these patients.” The study included 50 patients who had undergone total hip or knee replacement surgery. The researchers chose these surgeries for their standardized pain protocol before and after surgery. To decrease the number of commonly reported variables for sleep disruption—i.e., noise, lights and hospital staff—the researchers situated the patients for the study on a floor that observed quiet time from 10 p.m. to 6 a.m., when the doors are closed and lights are dimmed. The patients were evaluated for total sleep time, sleep efficiency, pain score and use of narcotics for pain. They found that patients in greater pain had significantly decreased sleep efficacy and woke up more frequently. The researchers suggested that better pain management could improve sleep and recovery time. The findings will be presented at the American Academy of Otolaryngology-Head and Neck Surgery’s annual meeting. —Martin Leung

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Continuing Medical Education

CME WRITTEN BY:

LESSON 313

Mark R. Jones, BA, MD* Senior Medical Student, Tulane School of Medicine, New Orleans, LA; and Research Associate, LSU School of Medicine, Department of Anesthesiology, New Orleans, LA (*anticipated) “Hyperthyroidism (1-3)”. Licensed under Creative Commons

Preanesthetic Assessment of the Patient With Hyperthyroidism

The Thyroid Gland

yperthyroidism affects about 1.3% of the population and the female-to-male ratio is 5:1. The incidence of Graves’ disease, the most common form of hyperthyroidism, is 4.6 per 1,000 in women.1 The thyroid gland is found in the anterior neck below the thyroid cartilage and around the trachea. It consists of 2 lateral lobes connected by a thin isthmus. In normal physiology, the thyroid gland manufactures the hormones triiodothyronine (T3) and thyroxine (T4) from a thyroglobulin precursor in the thyroid follicular cells. Both hormones are reversibly bound to circulating plasma proteins for transport to peripheral tissues. T3 binds to receptors in target cells with 10-fold greater affinity than T4, and is proportionately more active. Both hormones function to increase carbohydrate and fat metabolism; increase metabolic rate, minute ventilation, heart rate, and contractility; affect water and electrolyte balance; and potentiate normal activity of the central nervous system (CNS).2,3

Pathophysiology Many different disorders can cause hyperthyroidism. Risk factors include female sex, smoking, advanced age, and radiation.1,4 Genetic factors also play a role. The general clinical manifestations of hyperthyroidism do not specify the underlying cause, but unique problems unrelated to high levels of hormone can be seen in some diseases. The prevalent causes of hyperthyroidism with key clinical features are listed in Table 1. Other major signs and symptoms of hyperthyroidism/thyrotoxicosis that are found in different organ systems are discussed below.

Skin The skin tends to be soft, warm, and flushed due to increased blood flow. Excessive sweating is common due to increased calorigenesis, and is associated with heat intolerance. Thinning of the hair and skin is also common, occasionally with pruritus and hives. Thyroid dermopathy occurs in less than 5%, most frequently over the anterior and lateral aspects of the lower leg; hence the term pretibial myxedema. Typical lesions are raised, hyperpigmented papules on the skin overlying the shins and are seen only in Graves’ disease.5

Eyes Sympathetic overstimulation, mediated by increased α-adrenergic receptors in some tissues, results in a wide, staring gaze and lid lag in patients with hyperthyroidism.6 Only Graves’ disease results in ophthalmopathy and exophthalmos, which is the result of the accumulation of hydrophilic glycosaminoglycans and inflammation of the extraocular muscles, orbital fat, and connective tissue.7

Cardiovascular The cardiovascular effects of hyperthyroidism often are profound and clinically relevant to anesthesiologists. Over time, thyroid hormone increases cardiac output, contractility, blood pressure, systemic vascular resistance, and myocardial oxygen consumption and causes rhythm disturbances. Initially, resistance in peripheral arterioles is decreased through interaction of thyroid hormone with vascular smooth muscle, resulting in decreased mean arterial pressure. As a result, with mean arterial blood pressure lowered, the renin–angiotensin–aldosterone system is activated and renal sodium absorption increases. Ultimately, blood volume and preload increases. These changes can increase cardiac output 50% to 300%. Increased cardiac output, heart rate, and contractility contribute to systolic hypertension. Sinus tachycardia, supraventricular tachycardia, and atrial fibrillation are common rhythm disturbances. Atrial fibrillation occurs in 10% to 20% of patients and is most frequent in patients older than 50 years. Tachycardia may unmask previously asymptomatic coronary artery disease by increasing oxygen demand.8,9

Mark W. Motejunas, BA, MD* Senior Medical Student, Tulane School of Medicine, New Orleans, LA; and Research Associate, Department of Anesthesiology, Louisiana State University School of Medicine, New Orleans, LA (*anticipated)

Alan David Kaye, MD, PhD Professor and Chairman, Department of Anesthesiology, Louisiana State University School of Medicine, New Orleans, LA; and Professor, Department of Anesthesiology, Tulane School of Medicine, New Orleans, LA

REVIEWED BY: Charles Fox, MD Professor and Chairman, Department of Anesthesiology, Louisiana State University School of Medicine, Shreveport, LA

DISCLOSURES There are no relevant financial disclosures.

PROFESSIONAL GAPS Although hyperthyroidism is not uncommon, patients who come to the operating room often are medicated and euthyroid. Thus, the anesthetic care provider may not be aware of potential complications that can be caused by the disease.

TARGET AUDIENCE Anesthesiologists.

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

LEARNING OBJECTIVES At the completion of this activity, the reader will be able to: 1. Define hyperthyroidism and Graves’ disease. 2. Describe the special circumstances associated with the administration of anesthesia to hyperthyroid patients. 3. List the manifestations of hyperthyroidism and Graves’ disease. 4. Explain the pathophysiology of hyperthyroidism and Graves’ disease. 5. Determine appropriate preoperative assessment for a patient with hyperthyroidism and Graves’ disease. 6. Interpret the results of laboratory tests. 7. Formulate a plan for anesthesia and postoperative analgesia in a patient with hyperthyroidism and Graves’ disease. 8. Review treatment options for the hyperthyroid patient. 9. State the incidence and prevalence of hyperthyroidism and Graves’ disease. 10. Predict, recognize, and respond to common perioperative complications of hyperthyroid patients.

CLINICAL CASE A 36-year-old woman (height 157 cm, weight 55 kg), 4 weeks into treatment for hyperthyroidism, presented to the emergency room with acute appendicitis. She had a history of claustrophobia and a fear of needles. Her vital signs were within the normal range except her temperature was 99.1°F. On physical examination, she had exophthalmos but there was no evidence of enlarged goiter and her airway appeared normal (Mallampati I). White blood cell count was 12.1 billion/L and hemoglobin was 10.2 g/dL.

PREANESTHETIC ASSESSMENT Dr. Elizabeth A.M. Frost, who is the editor of this continuing medical education series, is clinical professor of anesthesiology at the Icahn School of Medicine at Mount Sinai in New York City. She is the author of Clinical Anesthesia in Neurosurgeryy (Butterworth-Heinemann, Boston) and numerous articles. Dr. Frost is past president of the Anesthesia History Association and former editor of the journal of the New York State Society of Anesthesiologists, Sphere. She is also editor of the book series based on this CME program, Preanesthetic Assessment, Volumes 1 through 3 (Birkhäuser, Boston) and 4 through 6 (McMahon Publishing, New York City). A Course of Study for AMA/PRA Category 1 Credit Read this article, reflect on the information presented, then go online (www.mssm.procampus.net) and complete the lesson post-test and course evaluation before November 30, 2015. (CME credit is not valid past this date.) You must achieve a score of 80% or better to earn CME credit. Time to Complete Activity: 2 hours

Release Date: December 1, 2014

Termination Date: November 30, 2015

Accreditation Statement The Icahn School of Medicine at Mount Sinai is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. Credit Designation Statement The Icahn School of Medicine at Mount Sinai designates this enduring material for a maximum of 2.0 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity. It is the policy of the Icahn School of Medicine at Mount Sinai to ensure objectivity, balance, independence, transparency, and scientific rigor in all CME-sponsored educational activities. All faculty participating in the planning or implementation of a sponsored activity are expected to disclose to the audience any relevant financial relationships and to assist in resolving any conflict of interest that may arise from the relationship. Presenters must also make a meaningful disclosure to the audience of their discussions of unlabeled or unapproved drugs or devices. This information will be available as part of the course material. Visit www.mssm.procampus.net today for instant online processing of your CME post-test and evaluation form. There is a registration fee of $15 for this non–industry-supported activity. For assistance with technical problems, including questions about navigating the website, call toll-free customer service at (888) 345-6788 or send an email to Customer.Support@ProCEO.com. For inquiries about course content only, send an email to ram.roth@mssm.edu. Ram Roth, MD, is director of PreAnesthetic Assessment Online and assistant professor of anesthesiology at The Icahn School of Medicine at Mount Sinai, New York, NY.

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Continuing Medical Education Metabolic/Endocrine

Bone

Patients with hyperthyroidism often have low serum total high-density lipoprotein and low-density lipoprotein, as well as lower total serum cortisol concentrations.10,11 This does not affect monitored anesthesia care requirements. Thyroid hormone also can interfere with glucose metabolism by acting as an insulin antagonist in the periphery, resulting in hyperglycemia.12

Bone density is decreased by stimulating bone resorption. Elevated alkaline phosphatase and osteocalcin concentrations suggest increased bone turnover. Patients with chronic hyperthyroidism thus experience osteoporosis with an increased risk for fracture.20

Neurologic Respiratory From the mass effect of a large goiter obstructing the trachea to increased oxygen consumption, hyperthyroidism can inflict many problems on respiratory function. Dyspnea and dyspnea on exertion are common, with the underlying cause ranging from those listed above as well as increased pulmonary arterial pressure, respiratory muscle weakness and decreased lung volume, and exacerbation of asthma, among others.13,14

Gastrointestinal Gut stimulation can result in hypermotility, malabsorption, diarrhea, and subsequent weight loss despite an increased appetite. Other problems that may be seen later include dysphagia due to goiter, vomiting, and abdominal pain.15

Hematologic Plasma volume is increased with an associated, but not equal, increase in red blood cell mass that culminates in a normochromic, normocytic anemia.16

Genitourinary Urinary frequency and nocturia are common complaints related to hyperthyroidism-mediated voiding dysfunction.17 Women experience low serum free estradiol as a consequence of high sex hormone–binding globulin (SHBG) concentrations, as well as high luteinizing hormone. These changes can produce oligomenorrhea, anovulatory infertility, and amenorrhea.18 Increased SHBG results in low serum free testosterone in men, but increased conversion of testosterone to estradiol. As a result, men may experience gynecomastia, erectile dysfunction, and reduced libido.19

Behavioral and personality changes such as nervousness, agitation, insomnia, and depression are frequently experienced. Cognitive impairments such as deficits in concentration, confusion, and amnesia are frequently reported. Tremor and proximal muscle weakness (thyroid myopathy) develop in nearly 50% of patients.21

Diagnosis Combinations of the symptoms cited here may indicate hyperthyroid disease on physical examination. Hyperactivity, rapid speech, and staring gaze combined with tachycardia and tremor, for example, are highly suggestive of hyperthyroidism.22 Findings specific to Graves’ disease include exophthalmos, periorbital and conjunctival edema, limitation of eye movement, and infiltrative dermopathy (pretibial myxedema).5,7 Thyroid enlargement (goiter) may or may not be readily apparent, depending on the cause of disease. Patients with Graves’ disease or toxic multinodular goiter experience thyroid enlargement ranging in size from minimal to massive. However, patients with painless thyroiditis may experience no thyroid enlargement whatsoever, which should alert the physician to the possibility of exogenous hyperthyroidism or struma ovarii.23 A solitary nodule is characteristic of a toxic thyroid adenoma. Lastly, the thyroid is painful and tender to palpation in subacute thyroiditis.24 The next step in the diagnosis of hyperthyroidism is to obtain thyroid function tests (TFTs). All patients with primary hyperthyroidism display a low thyroid-stimulating hormone (TSH), and a TSH assay remains the best method of detecting thyroid dysfunction at the cellular level. Minute changes in thyroid function status can induce drastic changes in TSH levels. Normal TSH levels range from 0.4 to 5.0 mU/L; a TSH level of 0.1 to 0.4 mU/L

Table 1. Prevalent Causes of Hyperthyroidism With Key Clinical Features Cause

Pathophysiology

Gland Sizea Tenderness

Toxic adenoma

Autonomous hormone production

Nontender

Toxic multinodular goiter

Autonomous hormone production

Tender

Subacute thyroiditis

Thyroid hormone leakage

Tender

Lymphocytic thyroiditis, postpartum thyroiditis, medication-induced thyroiditis

Thyroid hormone leakage

Nontender

Graves’ disease

Autoimmune thyroid-stimulating immunoglobulin

Nontender

Iodine-induced hyperfunctioning of thyroid gland (iodide ingestion, radiographic contrast, amiodarone [Cordarone])

Increased thyroid stimulation

Nontender

Functioning pituitary adenoma (TSH); trophoblastic tumors Increased thyroid stimulation (human chorionic gonadotropin)

Nontender

Factitial hyperthyroidism

Exogenous hormone intake

Nontender

Struma ovarii; metastatic thyroid cancer

Extraglandular production

Nontender

TSH, thyroid-stimulating hormone a In most cases. Table modified from Reid JR, Wheeler SF. Hyperthyroidism: diagnosis and treatment. Am Fam Physician. 2005;72:623-630.

with normal free T3 (FT3) and free T4 (FT4) signifies subclinical hyperthyroidism, and a TSH level less than 0.03 mU/L is defined as overt hyperthyroidism. Furthermore, patients with overt hyperthyroidism usually demonstrate high FT4 and T3 concentrations. It is not uncommon, however, for a patient to present with only T3 or FT4 elevated. Subclinical hyperthyroidism is notable for a below-normal TSH accompanied by normal serum FT4, T3, and FT3.25,26 Based on a physical examination positive for conspicuous symptoms as well as abnormal TFTs, a differential diagnosis can be established. Primary hyperthyroidism is suspected in all patients with low serum TSH and high FT4 and T3.27 Graves’ disease and nodular goiter patients typically have increases in T3 greater than T4 due to increased peripheral conversion of T4 to T3. Conversely, patients with amiodarone-induced thyroiditis present with high serum T4 and normal T3 as this drug inhibits the peripheral conversion of T4 to T3. A patient with a TSHsecreting pituitary adenoma, a very rare cause of hyperthyroidism, has normal to high serum TSH despite high FT4 and T3.27,28 Table 2 summarizes the presumptive diagnoses based on TSH and TFT status. Pregnant women also may experience hyperthyroidism. The diagnosis of hyperthyroidism in pregnancy parallels that of other hyperthyroid cases. Complications to the pregnancy itself are of concern, and may include the potential for spontaneous abortion, low birthweight, stillbirth, pre-eclampsia, and, in rare cases, heart failure. (The most common causes of hyperthyroidism in pregnancy are human chorionic gonadotropin [hCG]-mediated hyperthyroidism [1%-3% of pregnancies] and Graves’ disease [0.1%-1% of pregnancies]). The levels of serum hCG in a normal pregnancy rise soon after fertilization. TSH and hCG share significant homology, as the α-subunit of the former is almost identical to hCG. Prolonged high concentrations of hCG can cause a (usually) transient gestational hyperthyroidism. It is estimated that up to 20% of pregnant women develop subclinical hyperthyroidism not requiring therapy.29,30 After diagnosis of hyperthyroidism has been made, the next step is to determine the underlying cause. The etiology of the disease can be distinguished using 24-hour radioiodine uptake31 and divided into 2 mechanisms: hyperthyroidism with normal to increased radioiodine uptake suggests overproduction of hormone, whereas a near-absent radioiodine uptake indicates either inflammation and destruction of the thyroid with subsequent release of hormone systemically or an extrathyroidal source of thyroid hormone.32 The causes of hyperthyroidism are listed in Table 3 by radioiodine uptake status.

Treatment The treatment of primary hyperthyroidism involves symptomatic relief (β-blockers are the mainstay) and therapy to decrease the synthesis of new thyroid hormone,6,33 which requires thionamide therapy (methimazole or propylthiouracil [PTU]), radioiodine ablation, or surgery.34 The following scenarios are indications for surgery: • Very large goiters that cause upper airway obstruction or dysphagia, or that would require radioiodine therapy. • Nonfunctional thyroid nodule suspected as malignant. • Patients with hyperparathyroidism in addition to hyperthyroidism. • Pregnant women with allergies to antithyroid drugs and severe hyperthyroidism. • When other modalities have failed. The most feared complication associated with thyroid surgery is a rare, life-threatening condition called thyroid storm. Other potential complications include bleeding, nerve damage, and airway obstruction. Although thyroid storm can develop in patients

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Continuing Medical Education with chronic hyperthyroid, it is most often precipitated by an acute event such as thyroid or nonthyroidal surgery, trauma, or infection. The incidence has been shown to be 0.20 per 100,000 in hospitalized patients per year. Mortality is substantial, ranging from 10% to 30%. Findings, although rarely identified under general anesthesia, classically involve an exaggeration of the typical symptoms of hyperthyroidism, including tachycardia, hyperpyrexia, CNS dysfunction, and gastrointestinal distress, as well as tremor, warm and diaphoretic skin, and lid lag. Treatment of thyroid storm involves high-dose β-blockers, thionamides, iodine solution to block the thyroid hormone release, and glucocorticoids to reduce peripheral conversion of T4 to T3 and maintain vasomotor stability.35-37

Anesthetic Considerations Preoperative testing relevant to anesthetic care depends in part on the presentation but should include a complete blood count (looking for anemia), blood sugar levels, and radiologic studies of the neck. If there is a large goiter and bleeding may be an issue, a type and screen is indicated. With the advent of effective drugs such as methimazole and PTU, patients with hyperthyroidism undergoing elective surgery are nearly always euthyroid before the procedure.36 A 6- to 8-week course of either PTU or methimazole, if dosed correctly, will stabilize and normalize the T4 levels sufficiently.37 The surgeon should allow enough time preoperatively for these drugs to become effective. Both medications stall the synthesis of T4 and T3 within the thyroid gland itself. PTU has the added benefit of inhibiting the conversion of T4 to T3 in peripheral tissues by specifically inhibiting deiodinases within various cells. PTU is able to decrease the levels of the inactive metabolite, T4, as well as the active hormone, T3.36 If the patient is unable to undergo the full preoperative regimen of PTU or methimazole, protocols are designed to stabilize them more rapidly in emergent cases. An IV β-blocker, most commonly esmolol, in a bolus dose of 10 to 50 mg (250-500 mcg/kg undiluted) or in an infusion dose of 50 to 300 mcg/kg/ min (2.5 g in 250 mL 0.9% NaCl or 10 mg/mL), is administered

along with ipodate, glucocorticoids and oral or rectal PTU. To date, PTU does not have a form compatible with IV delivery. Esmolol will not affect the underlying pathology of hyperthyroidism but rather will act to normalize the heart rate and relieve many symptoms such as sweating and general anxiety. The β-blocker propranolol has tertiary effects similar to those of PTU and is able to obstruct the deiodinases converting T4 to T3. Dexamethasone, administered at a dose of 2 mg every 6 hours, is generally the glucocorticoid of choice, both inhibiting the peripheral conversion of T4 to T3 as well as decreasing thyroid hormone release directly. Lastly, ipodate acts to bind thyroid hormone receptors and can block these receptors from activation by free circulating thyroid hormones. This antagonistic effect can be substantial in an emergency setting; long-term use is associated with increased thyroid hormone stores and acts to possibly exacerbate the hyperthyroid state. Commonly, patients with hyperthyroidism present with a substantial goiter that compresses and/or deviates the underlying trachea. Any patient demonstrating substantial goiter should receive a computed tomography scan as part of the preoperative exam to determine the tracheal significance. Flow volume loops are rarely helpful in a routine setting; however, they may help with identifying airway compromise in patients with tracheal compression. Once the extent of the compression is evaluated, the intubation should proceed analogous to any other patient with a compromised airway, including the use of advanced airway devices. A reinforced endotracheal tube should be passed beyond the point of compression, and preoperative sedation should be minimized. Awake intubation may be the preferred technique.38 It should be noted that a surgical airway may be extremely challenging in these patients. Induction of anesthesia was typically accomplished with the use of thiopental, which, owing to its thioureylene nucleus, decreases the peripheral conversion of T4 to T3 as an added benefit. Because thiopental is currently not available, propofol is the induction agent of choice. Likewise, drugs that have properties that stimulate the sympathetic nervous system should be avoided. These include but are not limited to ketamine, pancuronium, atropine

and epinephrine.37 Because these patients have a general increase in sympathetic activity as well as sympathetic sensitivity, it is best to avoid any medication that could trigger these receptors. In this regard, dexmedetomidine may be useful. As of now, virtually all anesthesia maintenance drugs and techniques have demonstrated safety and efficacy in the patient with hyperthyroidism. As stated earlier, some investigators propose to avoid anticholinergic drugs and their sympathomimetic effects (tachycardia, interfering with sweating). In fact, despite increased metabolic demands, studies on hyperthyroid animals did not validate a need for an increased anesthetic dose.37 By the same token, the medically induced euthyroid patient has no change in monitored anesthesia care requirement. Studies have shown a significant increase in the hepatotoxic side effects of isoflurane when used on hyperthyroid rats, arguably due to increased metabolic abilities.37 However, the dearth of data concerning these outcomes on human patients has left these claims unsubstantiated. At present, there are no studies

Table 3. Hyperthyroidism Classified by Iodine Uptake Status Hyperthyroidism with normal or high radioiodine uptake Autoimmune thyroid disease Graves’ disease Hashitoxicosis Autonomous thyroid tissue (iodine-induced hyperthyroidism may appear as low uptake) Toxic adenoma Toxic multinodular goiter TSH-mediated hyperthyroidism TSH-producing pituitary adenoma Non-neoplastic TSH-mediated hyperthyroidism hCG-mediated hyperthyroidism Hyperemesis gravidarum Trophoblastic disease

Table 2. Thyroid Assessment Based on Functional Status Tests

Hyperthyroidism with a near-absent radioiodine uptake

Serum TSH

Serum Free T4

Serum T3

Assessment

Unremarkable hypothalamic–pituitary function

Thyroiditis Subacute granulomatous (de Quervain’s) thyroiditis Painless thyroiditis (silent thyroiditis, lymphocytic thyroiditis)

Normal

Euthyroid

Normal

Normal or high

Euthyroid hyperthyroxinemia

Normal

Normal or low

Euthyroid hypothyroxinema

Normal

Low

Normal or high

Euthyroid: T3 therapy

Amiodarone (also may cause iodine-induced hyperthyroidism)

Normal

Low normal or low

Normal or high

Euthyroid: thyroid extract therapy

Radiation thyroiditis

High

Low

Normal or low

Primary hypothyroidism

Palpation thyroiditis

High

Normal

Subclinical hypothyroidism

Low

High or normal

High

Hyperthyroidism

Excessive replacement therapy

Low

Normal

Subclinical hyperthyroidism

Intentional suppressive therapy

Postpartum thyroiditis

Exogenous thyroid hormone intake

Factitial hyperthyroidism

Abnormal hypothalamic–pituitary function Normal or high

High

TSH-mediated hyperthyroidism

Normal or lowa

Low or low-normal

Low or normal

Central hypothyroidism

T3, triiodothyronine; TSH, thyroid-stimulating hormone a In central hypothyroidism, serum TSH may be low, normal, or slightly high. Table modified from reference 40.

Ectopic hyperthyroidism Struma ovarii Metastatic follicular thyroid cancer hCG, human chorionic gonadotropin; TSH, thyroid-stimulating hormone Table modified from reference 40.

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Continuing Medical Education that demonstrate any adverse effects from desflurane or sevoflurane. It should be noted, however, that all inhalational agents can cause sympathetic hyperactivity. As noted here, the complication most feared during surgery on a patient with hyperthyroidism is thyroid storm. Currently, the mortality rate of patients experiencing thyroid storm is estimated to be as high as 20%.37 What makes the diagnosis and treatment so difficult is that the syndrome manifests much like malignant hyperthermia. Clinicians may test the T4 levels in hopes of differentiating the 2 syndromes without realizing that patients with thyroid storm may actually not have significantly elevated levels of thyroid hormones compared with their usual hyperthyroid state. In fact, there is no laboratory test currently available capable of definitively diagnosing thyroid storm. Treatment is similar to a patient with hyperthyroidism in the emergent setting.39 The most common drug regimen is the use of IV β-blockers to ideally decrease the heart rate to 90 bpm, IV dexamethasone at 2 mg every 6 hours, and oral PTU of 200 to 400 mg every 8 hours.37 Additionally, cooling blankets and ice packs may be used to combat hyperthermia, and IV fluids should be used as needed to combat inevitable dehydration and electrolyte imbalances.39

Bahn RS. Graves’ ophthalmopathy. N Engl J Med. 2010;362:726-738.

Klein I, Ojamaa K. Thyroid hormone and the cardiovascular system: from theory to practice. J Clin Endocrinol Metab. 1994;78:1026-1027.

25. Spencer CA, LoPresti JS, Patel A, et al. Applications of a new chemiluminometric thyrotropin assay to subnormal measurement. J Clin Endocrinol Metab. 1990;70:453-460.

Frost L, Vestergaard P, Mosekilde L. Hyperthyroidism and risk of atrial fibrillation or flutter: a population-based study. Arch Intern Med. 2004;164:1675-1678.

26. Baloch Z, Carayon P, Conte-Devolx B, et al. Laboratory medicine practice guidelines. Laboratory support for the diagnosis and monitoring of thyroid disease. Thyroid. 2003;13:3-126.

10.

O’Brien T, Katz K, Hodge D, et al. The effect of the treatment of hypothyroidism and hyperthyroidism on plasma lipids and apolipoproteins AI, AII and E. Clin Endocrinol. 1997;46:17-20.

27.

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Mishra SK, Gupta N, Goswami R. Plasma adrenocorticotropin (ACTH) values and cortisol response to 250 and 1 microg ACTH stimulation in patients with hyperthyroidism before and after carbimazole therapy: case-control comparative study. J Clin Endocrinol Metab. 2007;92:1693-1696.

28. Beck-Peccoz P, Persani L, Mannavola D, Campi I. Pituitary tumours: TSHsecreting adenomas. Best Pract Res Clin Endocrinol Metab. 2009;23:597-606.

Management of Case Presentation

20. Ross DS. Hyperthyroidism, thyroid hormone therapy, and bone. Thyroid. 1994;4:319-326.

The patient’s endocrinologist was in the emergency room when the anesthesia team arrived. After discussion of anesthetic options, the patient agreed to general anesthesia. PTU 400 mg was given immediately and continued every 8 hours throughout her hospital stay. EMLA cream (lidocaine 2.5% and prilocaine 2.5%) was used before venous cannulation. In the operating room, routine monitors were placed. Rapid sequence induction included propofol, lidocaine, fentanyl, and succinylcholine. Particular attention was paid to ensure that lubrication was placed in her eyes and the lids were closed with paper tape. Her heart rate was 96 bpm and esmolol, in 10 mg doses, was titrated to maintain a rate under 90 bpm. Dexamethasone, 2 mg IV, was given before induction and every 6 hours postprocedure. Cooling blankets were placed intraoperatively. She remained afebrile. Laparoscopic surgery was uneventful. The patient was discharged home on day 3 without issues.

Andersen OO, Friis T, Ottesen B. Glucose tolerance and insulin secretion in hyperthyroidism. Acta Endocrinol. 1977;84:576-587.

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Ayres J, Rees J, Clark TJ, Maisey MN. Thyrotoxicosis and dyspnoea. Clin Endocrinol. 1982;16:65-71.

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Kahaly G, Hellermann J, Mohr-Kahaly S, Treese N. Impaired cardiopulmonary exercise capacity in patients with hyperthyroidism. Chest. 1996;109:57-61.

15.

Rosenthal FD, Jones C, Lewis SI. Thyrotoxic vomiting. Br Med J. 1976;2:209-211.

16.

Nightingale S, Vitek PJ, Himsworth RL. The haematology of hyperthyroidism. Q J Med. 1978;47:35-47.

17.

Evered DC, Hayter CJ, Surveyor I. Primary polydipsia in thyrotoxicosis. Metabolism. 1972;21:393-404.

18.

Koutras DA. Disturbances of menstruation in thyroid disease. Ann N Y Acad Sci. 1997;816:280-284.

34. Singer PA, Cooper DS, Levy EG, et al. Treatment guidelines for patients with hyperthyroidism and hypothyroidism. Standards of Care Committee, American Thyroid Association. JAMA. 1995;273:808-812.

19.

Abalovich M, Levalle O, Hermes R, et al. Hypothalamic-pituitary-testicular axis and seminal parameters in hyperthyroid males. Thyroid. 1999;9:857-863.

35. Sarlis NJ, Gourgiotis L. Thyroid emergencies. Rev Endocr Metab Disord. 2003;4:129-136.

21.

Hollowell JG, Staehling NW, Flanders WD, et al. Serum TSH, T(4), and thyroid antibodies in the United States population (1988 to 1994): National Health and Nutrition Examination Survey (NHANES III). J Clin Endocrinol Metab. 2002;87:489-499.

Brent GA. Mechanisms of thyroid hormone action. J Clin Invest. 2012;122:3035-3043.

Oetting A, Yen PM. New insights into thyroid hormone action. Best Pract Res Clin Endocrinol Metab. 2007;21:193-208.

Holm IA, Manson JE, Michels KB, et al. Smoking and other lifestyle factors and the risk of Graves’ hyperthyroidism. Arch Intern Med. 2005;165:1606-1611.

Heymann WR. Cutaneous manifestations of thyroid disease. J Am Acad Dermatol. 1992;26:885-902.

Bilezekian JP, Loeb JN. The influence of hyperthyroidism and hypothyroidism on alpha- and beta-adrenergic receptor systems and adrenergic responsiveness. Endocrinol Rev. 1983;4:378-388.

Stern RA, Robinson B, Thorner AR, et al. A survey study of neuropsychiatric complaints in patients with Graves’ disease. J Neuropsychiatry Clin Neurosci. 1996;8:181-185.

22. Trzepacz PT, Klein I, Roberts M, et al. Graves’ disease: an analysis of thyroid hormone levels and hyperthyroid signs and symptoms. Am J Med. 1989;87:558-561. 23. Yoo SC, Chang KH, Lyu MO, et al. Clinical characteristics of struma ovarii. J Gynecol Oncol. 2008;19:135-138. 24. Fatourechi V, Aniszewski JP, Fatourechi GZ, et al. Clinical features and outcome of subacute thyroiditis in an incidence cohort: Olmsted County, Minnesota, study. J Clin Endocrinol Metab. 2003;88:2100-2105.

30. Ballabio M, Poshychinda M, Ekins RP. Pregnancy-induced changes in thyroid function: role of human chorionic gonadotropin as putative regulator of maternal thyroid. J Clin Endocrinol Metab. 1991;73:824-831. 31.

Shambaugh GE 3rd, Quinn JL, Oyasu R, Freinkel N. Disparate thyroid imaging. Combined studies with sodium pertechnetate Tc 99m and radioactive iodine. JAMA. 1974;228:866-869.

32. Izumi Y, Hidaka Y, Tada H, et al. Simple and practical parameters for differentiation between destruction-induced thyrotoxicosis and Graves’ thyrotoxicosis. Clin Endocrinol. 2002;57:51-58. 33. Geffner DL, Hershman JM. Beta-adrenergic blockade for the treatment of hyperthyroidism. Am J Med. 1992;93:61-68.

36. Bahn Chair RS, Burch HB, Cooper DS, et al. Hyperthyroidism and other causes of thyrotoxicosis: management guidelines of the American Thyroid Association and American Association of Clinical Endocrinologists. Thyroid. 2011;21:593-646. 37.

Stoelting R. Stoelting’s Anesthesia and Co-existing Disease (Rev./Expand. ed.). Philadelphia,PA: Churchill Livingstone/Elsevier; 2008.

38. Miller R. Miller’s anesthesia (Rev./Expand. ed.). New York, NY: Elsevier/ Churchill Livingstone; 2005. 39. Baeza A, Aguayo J, Barria M, Pineda G. Rapid preoperative preparation in hyperthyroidism. Clin Endocrinol. 1991;35:439-442. 40. Ross DS. Laboratory assessment of thyroid function. UpToDate.com. Accessed August 24, 2014.

Post-Test 1.

All of the following are manifestations of Graves’ disease, except _____. a. pretibial myxedema b. exopthalmos c. goiter d. anorexia

The euthyroid state can be achieved in hyperthyroid patients by 6 to 8 weeks of therapy with _____. a. propylthiouracil b. methimazole c. glucocorticoids d. A or B

_____ is the least appropriate agent for induction of anesthesia in the hyperthyroid patient. a. Dexmedetomidine b. Ketamine c. Etomidate d. Propofol

The most feared perioperative complication with hyperthyroid patients is _____. a. renal failure b. hepatotoxicity c. thyroid storm d. aneurysm

What is the most common age and sex associated with hyperthyroidism? a. Elderly man b. Adult woman c. Adolescent boy d. Adolescent girl

Which agent(s) should be avoided with respect to the hyperthyroid patient? a. Iodine b. Atropine c. Epinephrine d. B and C

Overt hyperthyroidism can be diagnosed with a thyroidstimulating hormone level of _____. a. >5.0 mU/L b. 0.4-5.0 mU/L c. 0.1-0.4 mU/L d. <0.03 mU/L

Treatment of thyroid storm should begin with _____. a. glucocorticoids b. propylthiouracil c. high-dose IV β-blockers d. opioids

The incidence of hyperthyroidism in women is _____. a. 53/100 b. 4.6/100 c. 1.8/10,000 d. 10.3/5,000

References 1.

29. Davis LE, Lucas MJ, Hankins GD, et al. Thyrotoxicosis complicating pregnancy. Am J Obstet Gynecol. 1989;160:63-70.

12.

Conclusion Hyperthyroidism and Graves’ disease are disorders that anesthesiologists may encounter. Knowledge of the challenges—such as thyroid storm and cardiovascular or respiratory dysfunction— and how to manage them are crucial for proper care. If at all possible, patients with hyperthyroidism should be made euthyroid preoperatively via PTU or methimazole. Perioperatively, anticholinergic and sympathomimetic drugs such as atropine and epinephrine should be avoided. Induction of anesthesia may be implemented via propofol, and maintenance can be achieved with any of the potent inhalational agents.

Surks MI, Chopra IJ, Mariash CN, et al. American Thyroid Association guidelines for use of laboratory tests in thyroid disorders. JAMA. 1990;263:1529-1532.

10. Hyperthyroid patients commonly experience _____. a. osteoporosis b. constipation c. autosplenectomy d. cold intolerance

DECEMBER 2014

AnesthesiologyNews.com I 29

CLASSIFIEDS Premier Anesthesia, a naƟonal anesthesia group with over 34 locaƟons naƟonwide, is seeking tŽ Įnd excepƟonal providers to join our winning team:

General Anesthesiologist Needed

Chief of Anesthesia Needed

St. Francis Hospital – Wilmington, DE

A chief posiƟon is available at our pracƟce in Wilmington, located only a short drive from Philadelphia, PA. This is a W-2 posiƟon with full beneĮts. The stĂĸng model is 5 MD / 10.5 CRNA. Call is 1 in 4 from home. DE license preferred.

Mount Carmel West – Columbus, OH

We are seeking a full Ɵme anesthesiologist with general experience for our rapidly expanding pracƟce in Columbus, OH. This is a 1099 posiƟon with 8 weeks of vacaƟon. Our stĂĸng model is 8 MD / 18 CRNA. Call is 1 in 7 from home. OH license preferred.

CV Anesthesiologist Needed

Mount Carmel West – Columbus, OH

We are seeking a full Ɵme anesthesiologist with CV experience for our rapidly expanding pracƟce in Columbus, OH. This is a 1099 posiƟon with 8 weeks of vacaƟon. Our stĂĸng model is 8 MD / 18 CRNA. OH license preferred.

If you are interested in any of these pŽƐŝƟons, or simply wish to inquire about other current and future permanent opportunŝƟĞs within the Premier Anesthesia organizaƟŽn, please contact Charles PaǇĞƩe in conĮdence at 770-643-5694 or email paǇĞƩe@premieranesthesia.com. For locums needs naƟonwide, contact Sarah Allen at 770-643-5781 or email sallen@premieranesthesia.com.

ANESTHESIOLOGIST OPPORTUNITY Physician only group in Davenport, IA, seeking full Ɵme BC/BE anesthesiologist. Cardiac and/or regional skills preferred. One year to partnership. 100% doing your own cases. CompeƟƟve salary. Home call. Variety of cases. Located in the Quad CiƟes, a family-friendly community on the Mississippi River with year-round acƟviƟes. Located 3 hours from downtown Chicago. Contact IowaAnes@gmail.com.

Department of Anesthesiology & Perioperative Care Various HS Clinical Professor Series, Open Ranks Clinical X Series, Open Ranks General Information: University of California Irvine Health System is seeking an interventional pain specialist to join the leading academic pain program in the region. Clinicians interested in pursuing an academic medicine career in the anesthesia subspecialty of Pain Medicine will be given the opportunity to grow in a dynamic department. Ample opportunities exist for scholarly effort and teaching through an ACGME approved Pain Medicine Fellowship. We are seeking candidates for Pain Medicine Faculty in the Health Sciences Clinical Professor series (Assistant, Associate, and/or Full Professor Levels) as well as in the Clinician Researcher (Clinical X) series. Candidates must be board certified in Anesthesiology, fellowship trained in Pain Medicine, certified by the ABA in pain management, and licensed to practice in California. Faculty rank and compensation will be commensurate with experience and qualifications. UC Irvine offers an excellent salary and benefit program.

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UC Irvine Health is located in Orange County with easy access from coastal communities including Newport Beach, Huntington Beach and Laguna Beach. Orange County has an ideal year round climate, averaging 280 sunny days and temperatures of 70-80°. Application Procedure: To apply for the HS Clinical Professor Series, please log onto UC Irvine’s recruitment site located at https://recruit.ap.uci.edu/apply/JPF02597 To apply for the Clinical X Series, please log onto UC Irvine’s recruitment site located at https://recruit.ap.uci.edu/apply/JPF02598 Applicants should complete an online application proﬁle and upload the following application materials electronically to be considered for this position: 1. Cover Letter 2. Curriculum Vitae 3. Names of at least three references and their contact information A separate statement that addresses past and/or potential contributions to diversity, equity and inclusion should also be included in the application materials. For more information, please visit the Department of Anesthesiology and Perioperative Care website at http://www.anesthesiology.uci.edu. The University of California, Irvine is an Equal Opportunity/Affirmative Action Employer advancing inclusive excellence. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, age, protected veteran status, or other protected categories covered by the UC nondiscrimination policy.

For classiﬁed advertising, contact Craig Wilson 212-957-5300 x235 cwilson@mcmahonmed.com

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30 I AnesthesiologyNews.com

DECEMBER 2014

POLICY & MANAGEMENT

Neeld Challenge Answered With CRNA Study Grant New Orleans—Last fall, John Neeld Jr., MD, past president of the American Society of Anesthesiologists (ASA) and chair emeritus of the Department of Anesthesiology at Northside Anesthesiology Consultants in Atlanta, challenged the ASA to allocate $1 million to study the differences in outcomes among patients who receive care from physician-anesthesiologists or certified registered nurse anesthetists (CRNAs). (The challenge was the lead article in the December 2013 edition of Anesthesiology News.) The ASA then offered a counterproposal—it would spend $470,000 between 2015 and 2017 to internally research the association between practice models and clinical and economic outcomes. The research will be conducted through the ASA’s Anesthesia Quality Institute (AQI) and the National Anesthesia Clinical Outcomes Registry (NACOR) it oversees. NACOR has data from more than 20 million anesthetic procedures, reported by individual anesthesia practices and

providers from a variety of settings. The research will be directed by Richard Dutton, MD, MBA, ASA’s chief quality officer and executive director of the AQI, and Thomas Miller, PhD, MBA, ASA’s director of health policy research. This recommendation, Dr. Neeld said, was “better than my original proposal” because it uses a research mechanism that already is in place and works. The proposal was approved at the ASA’s House of Delegates meeting in New Orleans. The AQI research will examine how care is delivered in particular hospital environments and for certain patients, as well as measure outcomes such as hospital lengths of stay, cost of care, clinical outcomes, readmission rates, side effects like nausea and vomiting and patient satisfaction, Dr. Dutton told Anesthesiology News. Investigators also will review data from the Centers for Medicare & Medicaid Services; the National Inpatient Sample (the country’s largest all-payorr care database); and registries such as the American College

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of Surgeons’ National Surgical Quality Improvement Program, an ongoing program that monitors and improves surgical care quality in private-sector hospitals. Although data reporting to NACOR is voluntary, Dr. Dutton said, the registry has 27,000 active participants, including 12,000 anesthesiologists, 10,000 CRNAs, and residents and fellows in a variety of settings. “What I suspect we’ll find is that anesthesia is really safe, and we deliver it safely under a variety of models,” Dr. Dutton said. The bigger question going forward, he said, is how best to keep that care safe, including trying to tease out which anesthesia delivery models lead to the best outcomes for particular types of patients and procedures. Delivering the Emery A. Rovenstine Memorial Lecture at last year’s ASA annual meeting, Dr. Neeldd argued that the research was necessary because CRNAs have been waging an effective political battle against anesthesiologists to supplant physicians wherever possible. One of their strongest weapons has been the paucity of evidence that physician-directedd care is better, or that nurse-directedd care is worse. “Policymakers don’t want to get down to the weeds on this,” he told Anesthesiology News. “They would like to have cheaper anesthetists to provide care.” But medical education is necessary, he said: “Anesthesiologists like myself … see every day where we step in and prevent little problems from becoming big problems.” Now, Dr. Neeldd said, “we finally will have the numbers to find out if we make a difference to patient care. We hope it tells our story, but if it doesn’t, it will nevertheless be the data” that determine the answers. A study published online in the Cochrane Database of Systematic Reviews (2014;7:CD010357) assessing the safety and effectiveness of different anesthetic providers found that “no definitive statement” could be made “about the possible superiority of one type of anaesthesia care over another.” Investigators searched four large databases including the Cochrane Central Register of Controlled Trials and MEDLINE, culling six nonrandomized studies of more than 1.5 million patients. Five were large retrospective cohort studies of routinely collected hospital and administrative data from the United States; the sixth was a smaller cohort study of emergency medical care in Haiti.

The results were a mixed bag: Most studies reported there was no difference in the number of people who died when given anesthetic by either a physician or CRNA. Much data came from large databases that may have contained inaccuracies in reporting, the authors said, and it may be that patients who were more ill were cared for by anesthesiologists or that nurse anesthetists worked in hospitals with fewer resources. Because of these inconsistencies, the authors “concluded that it was not possible to say whether there were any differences in care between medically qualified anesthetists and nurse anesthetists from the available evidence.” “Both professions would like research to demonstrate that they are better, or at the very least, no worse,” study coauthor Andrew Smith, FRCA, a consultant anesthesiologist and director of the Lancaster Patient Safety Research Unit at the Royal Lancaster Infirmary in England, said in an interview. “This question will probably never be answered,” in part because there would be “ethical and practical difficulties” in conducting a randomized controlled trial. “It is not the professional group from which you come, but a matter of experience and matching the skills needed for the anesthetic management to the needs of the particular case,” Dr. Smith said. Dr. Neeld doesn’t disagree with the Cochrane report’s conclusions. “They obviously think more work is needed.” It’s time to move past debates over who is best, said Lorraine Jordan, CRNA, PhD, executive director of the American Association of Nurse Anesthetists (AANA) Foundation. “There is really no definitive statement of which professional is better,” she said. The AANA would like to work with the ASA in focusing research efforts that meet the six priorities outlined by the Agency for Healthcare Research and Quality’s National Quality Strategy, such as making quality care more affordable and promoting coordination of care. “That would be the best statement to position ourselves moving forward. How much more time do we want to waste defending positions when we could do so much better improving patient safety and care?” Dr. Jordan asked. Dr. Neeld added, “What this is ultimately about is getting patients through inherently dangerous procedures safely.” —Karen Blum

Protect your hard-earned reputation by managing risk. Since 1987, Preferred Physicians Medical (PPM M) has exclusively insured anesthesiologists and their practices. Our pollicyholders also own PPM, so helping our physician owners manage theiir risk is a cornerstone of what makes us unique. PPM maintains a substantial database of morre than 11,000 adverse anesthesia events and uses this information to identify areas of risk, monitor developing loss trends, and provide cutting-edge, timely and practical anesthesia-specific risk managemen nt advice and strategies like: On-site risk management seminars fo or our policyholders and their staff presented by PPM in-house claim ms attorneys. Exclusive online access to best practicce protocols and documentation; white papers; curren nt and archived issues of Anesthesia & Law, our risk managemeent newsletter; and other useful information. Immediate email notification via Aneesthesia Alerts of issues such as widespread drug contaminatiion, drug shortages and significant changes to ASA standaards. 24/7/365 telephone access to our expeerienced attorneys and claims specialists for th he expert risk management advice you need, wh henever you need it. Call PPM today to learn more about how our extensive risk management program can help p you protect your reputation.

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