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Block Technique Holds Appeal for Tumor Surgery In Pregnant Women Regional anesthesia seen safer for mother, fetus

F

or most pregnant women, cancer is a distant concern. Yet for the one in every 3,000 pregnant women who develop breast cancer, anesthetic management during surgery to remove the tumors is a crucial consideration—made more so in light of recent research indicating that general anesthesia with opioid analgesia may promote the spread of cancer more than regional anesthesia. With paravertebral block anesthesia, clinicians at the University of Texas MD Anderson Cancer Center, in Houston, are honing a technique see paravertebral page 22

Controversy Dogs Use of β-blockers In Noncardiac Surgery New York—More than two years after the publication of the POISE trial suggested that use of β-blockers in patients undergoing noncardiac surgery might be more harmful than helpful, the therapy remains contentious. The study indicated a substantial risk for stroke with perioperative β-blockers in the largest such cohort ever studied, but some experts point out methodological flaws and increasingly consider that study damaging to patients. “The POISE [Perioperative Ischemic Evaluation] study clearly has serious and irreversible flaws in design, execution and safety oversight,” said Dennis T. Mangano, MD, PhD, founder of the nonprofit Ischemia Research and Education Foundation. “It’s clear that they got the beneficial effects of metoprolol [the β-blocker used

Life in a Fix: Confessions of an Addicted Physician Editor’s note: Joel Freedland, DO, is a selfhe 19-month sentence described physician addict. Dr. Freedland seemed particularly recently was released from a Michigan prison, obnoxious to me, so I where he served four years for defrauding decided to take an extra-judicial Medicaid. Before serving his sentence, he vacation (“absconded” is such an spent 17 years as a fugitive, living in the Middle East, South America and elsewhere. The following article is the final installment in a three-part series written by Dr. Freedland about his experiences. Anesthesiology News is unable to verify most of the statements made in these articles, as they represent personal recollections with no supporting information beyond the author’s assertions.

T

ugly word). I went to the Middle East, hoping to become an Israeli citizen, and I believed, safe from extradition. I had a difficult time finding work. I volunteered on a cooperative, or moshav, sorting tomatoes for about three months. Meanwhile, I consulted an attorney about becoming an Israeli citizen. The documents included a specific question about previous PART 3

in POISE], but they got serious complications. The trial should have been stopped one-third of the way through. The doses should have been changed, the design should have been different.” see POISE page 20

. A . 1 INSIDE 13 | TECHNOLOGY Home glucose meters entering OR, with mixed results.

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34 | POLICY & MANAGEMENT Look good in orange? Expert tips for avoiding a charge of billing fraud.

36 | PAIN MEDICINE Smoking is painful subject for surgical patients.

39 | CME—PREANESTHETIC ASSESSMENT Lesson 290: PreAnesthetic Assessment of The Pregnant Patient With Mitral Stenosis

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4 I AnesthesiologyNews.com

FEBRUARY 2011

HEARD HERE FIRST: A lot of people don’t think

the orange suit February 2011

is possible for them.

The five most-viewed articles last month on AnesthesiologyNews.com

But let me assure you,

1. The Company Model: Is Taking Less Money To Work at a Surgicenter Worth Jail Time?

it very much is.

2. Life in a Fix: Confessions of an Addicted Physician—Part 2 3. January 2011 Issue Recap Podcast

SEE ARTICLE ON PAGE 34.

4. Anesthesia Journal Retracts Fluid Paper Over Ethics Concerns (Web Exclusive) 5. Current Concepts in the Management of The Difficult Airway (Educational Review)

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e nt n se rta tio se po ma ea Im or Pl sed Inf y clo fet en Sa w Ne

WHEN CHOOSING AN IV SEDATIVE

Different situations require different solutions


Precedex : A right fit ®

FOR TODAY’S SEDATION MANAGEMENT PRACTICES


e nt n se rta tio se po ma ea Im or Pl sed Inf y clo fet en Sa w Ne

DIFFERENT SITUATIONS REQUIRE DIFFERENT SEDATIVE SOLUTIONS The first and only alpha2 agonist indicated for sedation1,2 —Nonintubated patients prior to and during surgical and other procedures1 —Intubated and mechanically ventilated patients during treatment in an intensive care setting1 Can be used alone or in combination with other sedatives or opioid analgesics to provide sedation and added patient comfort.1 Should be administered by continuous infusion not to exceed 24 hours.1 Effective for intubated patients not just before—but also during—and after extubation.1 More than 4.5 million vials administered to millions of patients since launch.3

IMPORTANT PRECEDEX SAFETY INFORMATION Clinically significant episodes of bradycardia, sinus arrest and hypotension have been associated with Precedex infusion and may necessitate medical intervention. Moderate blood pressure and heart rate reductions should be anticipated when initiating sedation with Precedex. Please see the brief summary of Prescribing Information on adjacent page.


Important New Safety Information In a controlled clinical trial, dexmedetomidine was compared to midazolam for ICU sedation exceeding 24 hours in duration, with maintenance doses of 0.2 to 1.4 mcg/kg/hr. Precedex® was not shown to be superior to midazolam for the primary efficacy endpoint, the percent of time patients were adequately sedated (81% with Precedex versus 81% with midazolam). Precedex is indicated for administration by continuous infusion not to exceed 24 hours. The approved maintenance dosages are 0.2 to 0.7 mcg/kg/hr for ICU sedation and 0.2 to 1 mcg/kg/hr for procedural sedation. The safety information highlighted below applies to the use of Precedex outside of its currently approved dosages and duration.

Warnings and Precautions Withdrawal With administration up to 7 days, regardless of dose used, 12 (5%) Precedex subjects experienced at least 1 event related to withdrawal within the first 24 hours after discontinuation and 7 (3%) experienced at least 1 event 24 to 48 hours after stopping treatment. The most common events related to withdrawal were nausea, vomiting and agitation. Tachycardia and hypertension requiring intervention in the first 48 hours following study drug discontinuation occurred at frequencies of less than 5%. If tachycardia and/or hypertension occurs after discontinuation of Precedex, supportive therapy is indicated. Tolerance and Tachyphylaxis Use of dexmedetomidine beyond 24 hours has been associated with tolerance, tachyphylaxis and a dose-related increase in adverse reactions [see Table 1 and Table 2]. Adverse Reactions Adverse reactions associated with infusion in ICU patients for periods greater than 24 hours in duration include ARDS, respiratory failure and agitation [see Table 1].


Adverse Event Hypotension1 Hypotension requiring intervention Bradycardia2 Bradycardia requiring intervention Systolic Hypertension3 Tachycardia4 Tachycardia requiring intervention Diastolic Hypertension3 Hypertension3 Hypertension requiring intervention† Hypokalemia Pyrexia Agitation Hyperglycemia Constipation Hypoglycemia Respiratory Failure Renal Failure Acute Acute Respiratory Distress Syndrome Generalized edema Hypomagnesemia

Dexmedetomidine (N=244) 56% 28% 42% 5% 28% 25% 10% 12% 11% 19% 9% 7% 7% 7% 6% 5% 5% 2% 2% 2% 1%

Midazolam (N=122) 56% 27% 19% 1% 42% 44% 10% 15% 15% 30% 13% 2% 6% 2% 6% 6% 3% 1% 1% 6% 7%

e nt n se rta tio se po ma ea Im or Pl sed Inf y clo fet en Sa w Ne

TABLE 1: KEY TREATMENT-EMERGENT ADVERSE EVENTS OCCURRING IN DEXMEDETOMIDINE- OR MIDAZOLAM-TREATED PATIENTS IN THE RANDOMIZED ACTIVE COMPARATOR CONTINUOUS INFUSION LONG-TERM ICU SEDATION STUDY

Includes any type of hypertension. 1. Hypotension was defined in absolute terms as systolic blood pressure of <80 mmHg or diastolic blood pressure of <50 mmHg or in relative terms as ≤30% lower than pre-study drug infusion value. 2. Bradycardia was defined in absolute terms as <40 bpm or in relative terms as ≤30% lower than pre-study drug infusion value. 3. Hypertension was defined in absolute terms as systolic blood pressure >180 mmHg or diastolic blood pressure of >100 mmHg or in relative terms as ≥30% higher than pre-study drug infusion value. 4. Tachycardia was defined in absolute terms as >120 bpm or in relative terms as ≥30% greater than pre-study drug infusion value.

The following adverse events occurred between 2 and 5% for Precedex and midazolam, respectively: renal failure acute (2.5%, 0.8%), acute respiratory distress syndrome (2.5%, 0.8%) and respiratory failure (4.5%, 3.3%). TABLE 2: PERCENT OF SUBJECTS WHO HAD A DOSE-RELATED INCREASE IN TREATMENT-EMERGENT ADVERSE EVENTS BY MAINTENANCE ADJUSTED DOSE RATE RANGE IN THE PRECEDEX GROUP Precedex mcg/kg/hr Adverse Event Constipation Agitation Anxiety Oedema peripheral Atrial fibrillation Respiratory failure Acute respiratory distress syndrome

” 0.7* N=95

! 0.7 to ”* N=78

! * N=71

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

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

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

* Average maintenance dose over the entire study drug administration.


Ne enc Pl w los ea Sa ed se fet Im se yI p e nfo ort rm ant ati on

The right fit FOR TODAY’S SEDATION MANAGEMENT PRACTICES

For step-by-step instructions on how to start using Precedex and what to expect, please visit us at www.Precedex.com. Moderate blood pressure and heart rate reductions should be anticipated when initiating sedation with Precedex.1 Clinically significant episodes of bradycardia and sinus arrest have occurred in young, healthy volunteers with high vagal tone or with different routes of administration such as rapid intravenous or bolus administration.1 Transient hypertension has been observed primarily during the administration of the loading dose. Treatment has generally not been necessary, although a reduction in loading dose infusion rate may be desirable.1

Hypotension and bradycardia can occur and may necessitate medical intervention such as —Decreasing or stopping Precedex infusion —Increasing rate of IV fluid administration —Elevating lower extremities —Administering pressor agents such as atropine, ephedrine or glycopyrrolate1 Use with caution in patients with advanced heart block or severe ventricular dysfunction.1 The most common adverse effects (incidence >2%) are hypotension, bradycardia and dry mouth.1

Please see the brief summary of Prescribing Information on adjacent page. References: 1. Precedex [package insert]. Lake Forest, IL: Hospira, Inc; 2010. 2. Kamibayashi T, Maze M. Clinical uses of α2-adrenergic agonists. Anesthesiology. 2000;93:1345-1349. 3. Data on file. Hospira, Inc.

Hospira, Inc. 275 North Field Drive, Lake Forest, IL 60045 P10-3082-Dec., 10. Printed in the USA.

Advancing Wellness™

For more information on Advancing WellnessTM, contact your Hospira representative at 1-877-9HOSPIRA (1-877-946-7747) or visit www.hospira.com.


Reference EN-2680

Precedex® (dexmedetomidine hydrochloride) injection

For Intravenous Use Rx only To report SUSPECTED ADVERSE REACTIONS, contact Hospira, Inc. at 1-800-441-4100 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 1 1.1

INDICATIONS AND USAGE Intensive Care Unit Sedation Precedex® is indicated for sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting. Precedex should be administered by continuous infusion not to exceed 24 hours. Precedex has been continuously infused in mechanically ventilated patients prior to extubation, during extubation, and post-extubation. It is not necessary to discontinue Precedex prior to extubation. 1.2 Procedural Sedation Precedex is indicated for sedation of non-intubated patients prior to and/or during surgical and other procedures. 4 CONTRAINDICATIONS None 5 WARNINGS AND PRECAUTIONS 5.1 Drug Administration Precedex should be administered only by persons skilled in the management of patients in the intensive care or operating room setting. Due to the known pharmacological effects of Precedex, patients should be continuously monitored while receiving Precedex. 5.2 Hypotension, Bradycardia, and Sinus Arrest Clinically significant episodes of bradycardia and sinus arrest have been reported with Precedex administration in young, healthy volunteers with high vagal tone or with different routes of administration including rapid intravenous or bolus administration. Reports of hypotension and bradycardia have been associated with Precedex infusion. If medical intervention is required, treatment may include decreasing or stopping the infusion of Precedex, increasing the rate of intravenous fluid administration, elevation of the lower extremities, and use of pressor agents. Because Precedex has the potential to augment bradycardia induced by vagal stimuli, clinicians should be prepared to intervene. The intravenous administration of anticholinergic agents (e.g., glycopyrrolate, atropine) should be considered to modify vagal tone. In clinical trials, glycopyrrolate or atropine were effective in the treatment of most episodes of Precedex-induced bradycardia. However, in some patients with significant cardiovascular dysfunction, more advanced resuscitative measures were required. Caution should be exercised when administering Precedex to patients with advanced heart block and/or severe ventricular dysfunction. Because Precedex decreases sympathetic nervous system activity, hypotension and/or bradycardia may be expected to be more pronounced in patients with hypovolemia, diabetes mellitus, or chronic hypertension and in elderly patients. In clinical trials where other vasodilators or negative chronotropic agents were co-administered with Precedex an additive pharmacodynamic effect was not observed. Nonetheless, caution should be used when such agents are administered concomitantly with Precedex. 5.3 Transient Hypertension Transient hypertension has been observed primarily during the loading dose in association with the initial peripheral vasoconstrictive effects of Precedex. Treatment of the transient hypertension has generally not been necessary, although reduction of the loading infusion rate may be desirable. 5.4 Arousability Some patients receiving Precedex have been observed to be arousable and alert when stimulated. This alone should not be considered as evidence of lack of efficacy in the absence of other clinical signs and symptoms. 5.5 Withdrawal Intensive Care Unit Sedation With administration up to 7 days, regardless of dose, 12 (5%) Precedex subjects experienced at least 1 event related to withdrawal within the first 24 hours after discontinuing study drug and 7 (3%) Precedex subjects experienced at least 1 event 24 to 48 hours after end of

study drug. The most common events were nausea, vomiting, and agitation. Tachycardia and hypertension requiring intervention in the 48 hours following study drug discontinuation occurred at frequencies of <5%. If tachycardia and/or hypertension occurs after discontinuation of Precedex supportive therapy is indicated. Procedural Sedation Withdrawal symptoms were not seen after discontinuation of short term infusions of Precedex (<6 hours). 5.6 Tolerance and Tachyphylaxis Use of dexmedetomidine beyond 24 hours has been associated with tolerance and tachyphylaxis and a dose-related increase in adverse reactions [see Adverse Reactions (6.1)]. 5.7 Hepatic Impairment Since Precedex clearance decreases with severity of hepatic impairment, dose reduction should be considered in patients with impaired hepatic function [see Dosage and Administration (2.2)]. 6 ADVERSE REACTIONS 6.1 Clinical Studies Experience Because clinical trials are conducted under widely varying conditions, adverse reactions rates observed in the clinical trials of a drug cannot be directly compared to rates in clinical trials of another drug and may not reflect the rates observed in practice. Use of Precedex has been associated with the following serious adverse reactions: • Hypotension, bradycardia and sinus arrest [see Warnings and Precautions (5.2)] • Transient hypertension [see Warnings and Precautions (5.3)] Most common treatment-emergent adverse reactions, occurring in greater than 2% of patients in both Intensive Care Unit and procedural sedation studies include hypotension, bradycardia and dry mouth. Intensive Care Unit Sedation Adverse reaction information is derived from the continuous infusion trials of Precedex for sedation in the Intensive Care Unit setting in which 1007 patients received Precedex. The mean total dose was 7.4 mcg/kg (range: 0.8 to 84.1), mean dose per hour was 0.5 mcg/kg/hr (range: 0.1 to 6.0) and the mean duration of infusion of 15.9 hours (range: 0.2 to 157.2). The population was between 17 to 88 years of age, 43% ≥65 years of age, 77% male and 93% Caucasian. Treatment-emergent adverse reactions occurring at an incidence of >2% are provided in Table 2. The most frequent adverse reactions were hypotension, bradycardia and dry mouth [see Warnings and Precautions (5.2)]. Table 2: Adverse Reactions With an Incidence >2%— Intensive Care Unit Sedation Population <24 hours*

Adverse Event Hypotension Hypertension Nausea Bradycardia Atrial fibrillation Pyrexia Dry mouth Vomiting Hypovolemia Atelectasis Pleural effusion Agitation Tachycardia Anemia Hyperthermia Chills Hyperglycemia Hypoxia Post-procedural hemorrhage Pulmonary edema Hypocalcemia Acidosis Urine output decreased Sinus tachycardia Ventricular tachycardia Wheezing Edema peripheral

All Randomized Precedex Precedex Placebo Propofol (N = 1007) (N = 798) (N = 400) (N = 188) (%) (%) (%) (%) 25% 12% 9% 5% 4% 4% 4% 3% 3% 3% 2% 2% 2% 2% 2% 2% 2% 2%

24% 13% 9% 5% 5% 4% 3% 3% 3% 3% 2% 2% 2% 2% 2% 2% 2% 2%

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

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

2% 1% 1% 1%

2% 1% 1% 1%

3% 1% 0 1%

4% 3% 2% 2%

1% 1%

1% 1%

0 1%

2% 2%

<1% <1% <1%

1% 1% 0

1% 0 1%

5% 2% 2%

* 26 subjects in the all Precedex group and 10 subjects in the randomized Precedex group had exposure for greater than 24 hours.

Adverse reaction information was also derived from the placebo-controlled, continuous infusion trials of Precedex for sedation in the surgical intensive care unit setting in which 387 patients received Precedex for less than 24 hours. The most frequently observed treatmentemergent adverse events included hypotension, hypertension, nausea, bradycardia, fever, vomiting, hypoxia, tachycardia and anemia (see Table 3). Table 3: Treatment-Emergent Adverse Events Occurring in >1% Of All Dexmedetomidine-Treated Patients in the Randomized Placebo-controlled Continuous Infusion <24 Hours ICU Sedation Studies Adverse Event

Randomized Dexmedetomidine (N = 387)

Placebo (N = 379)

28% 16% 11% 7% 5% 4% 4% 4% 3% 3% 3% 3% 2% 2% 2% 2% 2% 2% 2% 2% 2%

13% 18% 9% 3% 4% 6% 3% 4% 5% 4% 2% 1% 3% 3% 3% 2% 2% 2% 1% <1% <1%

Hypotension Hypertension Nausea Bradycardia Fever Vomiting Atrial Fibrillation Hypoxia Tachycardia Hemorrhage Anemia Dry Mouth Rigors Agitation Hyperpyrexia Pain Hyperglycemia Acidosis Pleural Effusion Oliguria Thirst

In a controlled clinical trial, Precedex was compared to midazolam for ICU sedation exceeding 24 hours duration. Key treatment emergent adverse events occurring in dexmedetomidine or midazolam treated patients in the randomized active comparator continuous infusion long-term intensive care unit sedation study are provided in Table 4. The number (%) of subjects who had a dose-related increase in treatment-emergent adverse events by maintenance adjusted dose rate range in the Precedex group is provided in Table 5. Table 4: Key Treatment-Emergent Adverse Events Occurring in Dexmedetomidine- or Midazolam-Treated Patients in the Randomized Active Comparator Continuous Infusion Long-Term Intensive Care Unit Sedation Study* Adverse Event Hypotension1 Hypotension requiring intervention Bradycardia2 Bradycardia requiring intervention Systolic Hypertension3 Tachycardia4 Tachycardia requiring intervention Diastolic Hypertension3 Hypertension3 Hypertension requiring intervention† Hypokalemia Pyrexia Agitation Hyperglycemia Constipation Hypoglycemia Respiratory Failure Renal Failure Acute Acute Respiratory Distress Syndrome Generalized edema Hypomagnesemia

Dexmedetomidine (N=244)

Midazolam (N=122)

56%

56%

28% 42%

27% 19%

5% 28% 25%

1% 42% 44%

10% 12% 11%

10% 15% 15%

19% 9% 7% 7% 7% 6% 5% 5% 2%

30% 13% 2% 6% 2% 6% 6% 3% 1%

2% 2% 1%

1% 6% 7%

† Includes any type of hypertension. 1 Hypotension was defined in absolute terms as Systolic blood

pressure of <80 mmHg or Diastolic blood pressure of <50 mmHg or in relative terms as ≤30% lower than pre-study drug infusion value. 2 Bradycardia was defined in absolute terms as <40 bpm or in relative terms as ≤30% lower than pre-study drug infusion value. 3 Hypertension was defined in absolute terms as Systolic blood pressure >180 mmHg or Diastolic blood pressure of >100 mmHg or in relative terms as ≥30% higher than pre-study drug infusion value. 4 Tachycardia was defined in absolute terms as >120 bpm or in relative terms as ≥30% greater than pre-study drug infusion value.


The following adverse events occurred between 2 and 5% for Precedex and Midazolam, respectively: renal failure acute (2.5%, 0.8%), acute respiratory distress syndrome (2.5%, 0.8%), and respiratory failure (4.5%, 3.3%). Table 5. Number (%) of subjects who had a dose-related increase in Treatment Emergent Adverse Events by maintenance adjusted dose rate range in the Precedex group Precedex mcg/kg/hr Adverse Event

≤ 0.7* N = 95

> 0.7 to ≤ 1.1* N = 78

> 1.1* N = 71

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

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

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

1%

3%

9%

Constipation Agitation Anxiety Oedema peripheral Atrial fibrillation Respiratory failure Acute Respiratory Distress Syndrome

*Average maintenance dose over the entire study drug administration

Procedural Sedation Adverse reaction information is derived from the two trials for procedural sedation in which 318 patients received Precedex. The mean total dose was 1.6 mcg/kg (range: 0.5 to 6.7), mean dose per hour was 1.3 mcg/kg/hr (range: 0.3 to 6.1) and the mean duration of infusion of 1.5 hours (range: 0.1 to 6.2). The population was between 18 to 93 years of age, 30% ≥65 years of age, 52% male and 61% Caucasian. Treatment-emergent adverse reactions occurring at an incidence of >2% are provided in Table 6. The most frequent adverse reactions were hypotension, bradycardia, and dry mouth [see Warnings and Precautions (5.2)]. Pre-specified criteria for the vital signs to be reported as adverse reactions are footnoted below the table. The decrease in respiratory rate and hypoxia was similar between Precedex and comparator groups in both studies. Table 6: Adverse Reactions With an Incidence > 2%—Procedural Sedation Population

Adverse Event Hypotension1 Respiratory depression2 Bradycardia3 Hypertension4 Tachycardia5 Nausea Dry mouth Hypoxia6 Bradypnea

Precedex N = 318 (%)

Placebo N = 113 (%)

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

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

1

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

2

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

3

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

4

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

5

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

6

Hypoxia was defined in absolute and relative terms as SpO2 <90% or 10% decrease from baseline.

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

Table 7: Adverse Reactions Experienced During Post-approval Use of Precedex Body System

Preferred Term

Body as a Whole

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

Cardiovascular Disorders, General

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

Central and Peripheral Nervous System Disorders

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

Gastrointestinal System Disorders

Abdominal pain, diarrhea, vomiting, nausea

Heart Rate and Rhythm Disorders

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

Liver and Biliary System Disorders

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

Metabolic and Acidosis, respiratory acidosis, Nutritional Disorders hyperkalemia, increased alkaline phosphatase, thirst, hypoglycemia Psychiatric Disorders

Agitation, confusion, delirium, hallucination, illusion

Red Blood Cell Disorders

Anemia

Renal Disorders

Blood urea nitrogen increased, oliguria

Respiratory System Disorders

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

Skin and Appendages Disorders

Increased sweating

Vascular Disorders

Hemorrhage

Vision Disorders

Photopsia, abnormal vision

10

OVERDOSAGE The tolerability of Precedex was studied in one study in which healthy subjects were administered doses at and above the recommended dose of 0.2 to 0.7 mcg/kg/hr. The maximum blood concentration achieved in this study was approximately 13 times the upper boundary of the therapeutic range. The most notable effects observed in two subjects who achieved the highest doses were first degree atrioventricular block and second degree heart block. No hemodynamic compromise was noted with the atrioventricular block and the heart block resolved spontaneously within one minute. Five patients received an overdose of Precedex in the intensive care unit sedation studies. Two of these patients had no symptoms reported; one patient received a 2 mcg/kg loading dose over 10 minutes (twice the recommended loading dose) and one patient received a maintenance infusion of 0.8 mcg/kg/hr. Two other patients who received a 2 mcg/kg loading dose over 10 minutes, experienced bradycardia and/or hypotension. One patient who received a loading bolus dose of undiluted Precedex (19.4 mcg/kg), had cardiac arrest from which he was successfully resuscitated.

6.2

Manufactured and Distributed by: Hospira, Inc. Lake Forest, IL 60045 USA Licensed from: Orion Corporation Espoo, Finland Printed in USA Hospira, Inc., Lake Forest, IL 60045 USA


AnesthesiologyNews.com I 13

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TE CH N OL OG Y

Accuracy of Point-of-Care Glucometer Found Wanting Retrospective study found poor performance of device in hypoglycemic range

Blood–Accu-Chek Glucose, mg/dL

San Diego—Point-of-care glucometers seem to be gaining a foothold in the operating room. In a recent study, however, one such device was found to provide inaccurate readings in patients with diabetes undergoing surgery. Researchers at Jefferson Medical College in Philadelphia concluded that if the Accu-Chek blood glucose meter (Roche Diagnostics) alone was relied on during intensive insulin therapy (blood glucose target, 80-110 mg/ dL), the incidence of unrecognized hypoglycemia would be more than 10%. They recommended that central laboratory values be obtained to confirm blood glucose levels if an intensive insulin protocol is being followed. “The accuracy of point-of-care glucose devices compared with central lab devices has come into question in the past several years, with several studies showing that

they perform particularly poorly in the hypoglycemic range,” said Eric Schwenk, MD, an anesthesia resident at Jefferson, who helped conduct the research. “Since there aren’t a whole lot of intraoperative data out there, we wanted to assess the accuracy of the point-ofcare glucometer as compared with nearsimultaneous central lab values. We also wanted to determine the risk of only relying on the Accu-Chek if you’re following an intensive insulin therapy protocol.” Dr. Schwenk reported the findings at the 2010 annual meeting of the American Society of Anesthesiologists (abstract A192). The investigators queried their institution’s anesthesia information management system for the times and values of intraoperative blood glucose in patients with diabetes who underwent surgery between November 2005 and January 2010.

200 150 100 50 0 -50 -100 -150 -200

+2 SD

-2 SD

0

100

200

300

400

Central Lab Glucose, mg/dL

Figure 1. Simultaneous measurements (within 20 minutes) of blood glucose from glucometer and central laboratory. SD, standard deviation

Blood–Accu-Chek Glucose, mg/dL

400 C

350

A A

300 E

250 B

200

B

150

D

D B

100 50

E

C

0

50

100

150

200

250

300

350

400

Central Lab Glucose, mg/dL Figure 2. Clarke error grid analysis of Accu-Chek and central laboratory values.

‘There is a potential risk for unrecognized hypoglycemia if only the Accu-Chek is used, especially in conjunction with an intensive insulin therapy protocol, whether it be in the ICU or the intraoperative setting.’ —Eric Schwenk, MD Laboratory specimens received within 20 minutes of the Accu-Chek readings were considered to be simultaneous. Of 80,379 records, the researchers identified 10,996 cases in patients with diabetes (13.68%). In 6,727 of these cases, blood glucose levels had been determined at least once intraoperatively by Accu-Chek glucometer or a central laboratory; 307 were considered to be simultaneous measurements. The mean absolute difference in blood glucose levels between the Accu-Chek and central laboratory readings was 24.1 (Figure 1). Bias was –4 mg/dL. Dr. Schwenk and colleagues fit the differences in blood glucose values into a Laplace (or double exponential) curve. They found that of the values obtained with the Accu-Chek, 5% would be at least 59 mg/dL higher and 5% would be at least 49 mg/dL lower than the central laboratory values. Their analysis also revealed that 80% of Accu-Chek values would be within –33 and +43 mg/dL of the laboratory values; and 75.4% would be within 20% of central laboratory values. Roche Diagnostics declined to comment for this article. In the Clarke error grid analysis shown in Figure 2, section A represents Accu-Chek values within 20% of central laboratory values. Section B represents Accu-Chek values greater than 20% from reference values, but not resulting in inappropriate therapy. Section C represents potential overtreatment. In section D, potential misses of dangerous hyperglycemia and/or hypoglycemia are represented. And in section E, values representing confusion of hypoglycemia and hyperglycemia are shown. “We had four patients in the inappropriate treatment section [section C],” Dr. Schwenk said, “and three patients with potentially missed hypo- or hyperglycemia [section D]. “Although the overall accuracy of the Accu-Chek was poor, very few of our patients were at risk for harm,” he said. “There is, however, a potential risk for

unrecognized hypoglycemia if only the Accu-Chek is used, especially in conjunction with an intensive insulin therapy protocol, whether it be in the ICU [intensive care unit] or the intraoperative setting.” Mark J. Rice, MD, associate professor of anesthesiology at the University of Florida in Gainesville, co-authored a review on the challenges of measuring perioperative glucose (Anesth Analg 2010;110:1056-1065). They agreed that point-of-care glucose meters have limitations. “They’re faster and cheaper, but they’re not always accurate,” Dr. Rice said in a recent statement. “They were regulated and approved for home use, then in stealth fashion they ended up in the hospitals.” In their review, Dr. Rice, his Florida colleague, Andrew Pitkin, MD, and and Douglas B. Coursin, MD, professor of anesthesiology and medicine at the University of Wisconsin School of Medicine and Public Health in Madison, emphasized that the intermonitor accuracy of the devices varies considerably, and they should not be used alone routinely in the ICU or with sicker operative patients. Insufficient data demonstrate their accuracy at the lower limits of glucose measurement, they added. “Finally, the FDA has put forth guidelines about such use,” the authors wrote. The FDA’s draft guidance advises that glucometer manufacturers should “clarify that critically ill patients (e.g., those with severe hypotension or shock, hyperglycemic-hyperosmolar state, hypoxia, severe dehydration, diabetic ketoacidosis) should not be tested with blood glucose meters because inaccurate results may occur.” The FDA’s most recent guidance document, issued in 2006, is available at http://www.fda.gov/medicaldevices/ deviceregulationandguidance/guidancedocuments/ucm079138.htm. A revised version of the document is not yet available to the public. —Michael Vlessides


14 I AnesthesiologyNews.com

FEBRUARY 2011

T E C H NO L O G Y

Using AIMS To Manage Lines Helps Hospital Trim Costs San Diego—A real-time notification system can improve documentation of invasive lines, and in the process significantly improve a hospital’s bottom line, researchers have shown. The system was able to capture documentation for an additional 52

arterial lines, seven central lines and six pulmonary artery catheters each month, resulting in an increase in annual revenue through fees of nearly $145,000. “Professional fee billing of invasive lines requires documentation

Table. An AIMS System Improves Documentation of Lines While Raising Revenue Before SAM

After SAM

Annualized Additional Lines Captured With SAM

Estimated Annual Increase In Fee Capture

Arterial line

73.3±9.7% (n=640)

99±0.9% (n=570)

52×12=624

624×$147=$91,728

CVP

89.1±4.3% (n=217)

98.7±1.1% (n=226)

7×12=84

84×$349=$29,316

PA catheter

75.3±3% (n=78)

99±1.7% (n=92)

6×12=72

72×$329=$23,688

Total savings

$144,732

AIMS, anesthesia information management system; CVP, central venous pressure; PA, pulmonary artery; SAM, Smart Anesthesia Messenger

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of two elements,” said Bala G. Nair, PhD, acting assistant professor of anesthesiology and pain medicine at the University of Washington Medical Center in Seattle. “One is the physician attesting in what capacity he or she participated in the placement of the line. The second is the actual documentation of the line itself.” Although the University of Washington Medical Center had previously installed an anesthesia information management system (AIMS) to improve billing capture, anesthesiologists at the institution often failed to document their use of invasive lines, despite attesting to the procedure. To help counter this problem, researchers at the institution created the Smart Anesthesia Messenger (SAM), a decision support system that analyzes real-time AIMS data. In the new study, the system generated real-time notification messages if it detected an attestation related to an invasive line but no corresponding procedure note. Such errors were displayed in popup message screens that were overlaid on top of the AIMS screens every six minutes. The researchers analyzed data related to invasive line procedures for three-month periods before and after implementation of the SAM system. The investigators considered documentation to be complete if both the see lines page 19


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TE CH N OL OG Y

New Device To ID Epidural Space May Aid Less-Experienced Clinicians San Diego—A new device, the Epidrum, allows clinicians to more easily identify the epidural space, in a randomized controlled trial. When the device was compared with the loss-ofresistance (LOR) method, the difference was especially noteworthy among inexperienced operators. The Epidrum (Exmoor Innovations Ltd.) is placed between the needle and syringe, and charged with air to expand a diaphragm. When the needle penetrates the epidural space, the diaphragm will collapse suddenly, providing clear visual indicators of success. In vitro studies of the device demonstrated its superiority over the LOR technique.

the conventional group (P=0.554). The investigators also assessed ease of use of the device based on operator reports. The median score was 8 for ease of use of the Epidrum, compared with 7 for the LOR method (P=0.021). Usage was categorized as “easy” in 169 patients in the

Epidrum group, compared with 143 in the conventional group (P=0.011); among Epidrum patients, 11 were classified as “difficult,” compared with 27 in the LOR group (P=0.005). see space page 17

The Epidrum, from Exmoor Innovations Ltd.

Water in the OR: What are the Risks?

‘Although it may be innovative … I am not so sure it will catch on in anesthesia practice.’ —Manuel C. Vallejo, MD Maan Hasan, FRCA, consultant anesthetist at University College London Hospitals in England, said the original impetus for his involvement in developing the device was to improve the ease with which epidural needles are inserted and to reduce associated complications. In the study by Dr. Hasan and his colleagues, 31 different operators with varying degrees of experience performed epidural needle insertions on 437 patients. The Epidrum was used in 220 patients; the traditional LOR method was applied to the remaining 217. Results of the trial were presented at the 2010 annual meeting of the American Society of Anesthesiologists (abstract A495). Fewer failed procedures occurred in the Epidrum group, but this did not reach statistical significance (nine vs. 18; P=0.068). By other measures, however, use of the Epidrum was superior to the LOR method. For example, in 26 patients in the Epidrum group more than two attempts were required to identify the epidural space, compared with 48 patients in the conventional group (P=0.004). There also were fewer false-positive signals with the Epidrum than the LOR method (five vs. 14; P=0.032). There was one falsenegative in the device group and two in

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T E C H NO L O G Y

To Err Is Still Human: Medication Errors Are A Persistent Challenge

M

ore than a decade has passed since the Institute of Medicine published its landmark report on medical errors, “To Err Is Human,” which found that as many as 98,000 people die as a result of preventable medical errors every year. After 10 years of intense focus on quality improvement in health care, you’d think things might have gotten better. But according to two new studies, they haven’t. A recent report from the Department of Health and Human Services Office of Inspector General (OIG) found that 13.5% of Medicare beneficiaries—134,000 patients—experienced some type of adverse event during a sample month (October 2008). Some 15,000 patients who died during that month were victims of medical errors that contributed at least in part to their deaths. Meanwhile, a study of 10 North Carolina hospitals published in The New

England Journal of Medicine in November (2010;363:2124-2134) found that 18% of patients were harmed by medical care, and in many of those cases (63.1%) the injuries were preventable. In a small but significant number of cases (2.4%), the errors had a part in the patient’s death. Many of these lapses (31% in the OIG report and 28% in the North Carolina hospitals) were medication errors—a fact that doesn’t surprise Lyle Matthews, PharmD, director of pharmacy at Eisenhower Medical Center in Rancho Mirage, Calif. “In a hospital, every interaction with a patient has the potential for error. That said, the pharmacy carries the major portion of that risk, based on the sheer volume of medications dispensed, and the potential side effects and adverse drug reactions associated with those medications.” Indeed, more than 7,000 patients die each year due to medication errors, according to a 2006 governent report.

‘We have a long way to go, but I don’t think we should lose sight of the progress that’s already happened.’ —Michael Cohen, RPh, MS, ScD Why hasn’t more headway been made against this problem, and what can be done? One reason that errors are still so prevalent may be that it has taken time to develop, implement and adopt the technologies needed to reduce medication errors, according to Kevin Scheckelhoff, RPh, MBA, senior managing consultant with McKesson Pharmacy Optimization. “We’re not going to see the benefit right away. It’s not like turning on a light

Award to Christiana for Cutting Hydromorphone-related Adverse Events

A

five-year project to improve injectable hydromorphone safety at Christiana Care Health Services in Wilmington, Del., reduced adverse events related to the drug to zero and increased compliance with recommended dosing ranges from 64% to 84%. The effort received a Cheers Award from the Institute for Safe Medication Practices, presented at the 2010 midyear meeting of the American Society of Hospital Pharmacists in December. “Hydromorphone is our primary acute pain opioid injectable,” said Terri Corbo, PharmD, medication safety officer and director of clinical pharmacy services at Christiana Care. “It’s a high-volume, high-alert drug. Prior to initiating the program, we had seen an increase in hydromorphone use and realized that we needed to take steps for appropriate prescribing in order to limit adverse events.” At the time, Christiana Care did not have computerized prescriber order entry (CPOE), so the tools available to the pharmacy team were limited. “We established dose ranges based on age [less than 65 years and 65 or older], standardized our paper order sets and put out pocket guides to appropriate hydromorphone dosing,” Dr. Corbo said. Additionally, “we delivered education

programs, with pharmacists and doctors going out to speak to sections and departments.” When CPOE was established at Christiana Care, one of the pharmacy’s first priorities was hydromorphone. The hospital’s CPOE system can be programmed so that either the physician can fill in the desired dosage for a drug, or a preset dosage can automatically be filled in. “For hydromorphone, we hard-wired the dosages into the system and built it so that only our recommended dosage, based on age, would come up,” she said. Sometimes opioid-tolerant chronic pain patients do need hydromorphone doses outside the usual range, so doctors can override the system. If a doctor prescribes a dose outside the usual range, the system issues an alert reminding the clinician why the default dose is set, by describing the risk for falls and other adverse events such as respiratory distress. When the campaign began, 64% of hydromorphone prescriptions fell within the recommended dosing range. The education campaign raised that proportion to 74%; after CPOE was implemented, it reached 84%. “It’s important to note that this [compliance] figure can never be 100%,” Dr. Corbo noted. “We have more than 1,000 beds and are a central draw for

a lot of service lines, including chronic pain patients who can’t be backed down to the initial dosing range.” At baseline, many physicians were writing orders for 1 mg of hydromorphone because the drug comes in a 1-mg syringe. “The doctors figured if it came in that formulation, that was the dosage they should use,” Dr. Corbo said. “Even after we educated them that packaging does not dictate appropriate dosing, 34% of initial hydromorphone orders were still prescribed at 1 mg. With CPOE, that dropped to 18%.” The rate of hydromorphone-related adverse events at Christiana Care fluctuated prior to and throughout the campaign, but during the first two quarters after implementation of CPOE, adverse events related to hydromorphone totaled zero. Education on the potency of hydromorphone and proper safety precautions continues. “Every time we have an event or learn a lesson from a doctor who’s prescribed this drug, we’ll do an analysis,” Dr. Corbo said. “And we have a new residency class every year, and a new group of people who need to be informed about the appropriate prescribing of hydromorphone. You’re never done.”

—Gina Shaw

switch.” For example, a 2008 practice survey by the American Society of Health-System Pharmacists found that only 23% of hospital pharmacies had adopted bar code medication administration (BCMA) technology, and just 44% had implemented smart IV infusion pumps, two technologies that have been found to play a key role in reducing medication errors. “A lot of this is still building,” said Mr. Scheckelhoff. “As more and more hospitals acquire this technology, you’re going to see positive results.” Eisenhower was one of the first hospitals in California to adopt BCMA technology, and has been using it since 2003. “Bedside bar-code administration and verification of medication has eliminated a lot of errors that we otherwise might not have caught,” Dr. Matthews said. “Over the past five years, we’ve decreased our significant medication errors by at least 90%. Next, we’re going to upgrade to a system whereby when we receive an order, it already has the patient-identifying bar code on the order itself. It’s verified at the physician level and automatically goes into the pharmacy system under the correct patient’s name prior to the pharmacist’s final review and check. That’s another chance for human error to be taken out of the system.” In 2009, Eisenhower began phasing in an automated physician order entry system; by the end of 2010, all physicians were required to use it. Automated Reporting Helps Reduce Heparin Errors by 70% Automated systems have led to major changes at Northeast Georgia Health System (NGHS), in Gainesville, said director of pharmacy services Steve Carlson, RPh, MHA. “We use an automated reporting system called RL Solutions,” he said. “Our [medication error] reporting rate did go up, but that’s what happens when you have an automated


FEBRUARY 2011

AnesthesiologyNews.com I 17

TE CH N OL OG Y system versus a written one. Reporting is a good thing, not a bad thing.” NGHS adopted McKesson’s MedCarousel automated dispensing system, as well as a robot. “Our goal is to reduce human touch as much as possible using bar-coding technology,” Mr. Carlson said. “With high-risk drugs, it’s much easier to put them in the carousel and separate them clearly. We now have many fewer picking errors. We have wireless smart pumps, bar coding at the bedside and the vast majority of the pharmacy is automated. We also are in the process of building a computerized physician order entry system.” NGHS also has begun using Six Sigma methodology, a quality improvement approach aimed at a zero error rate that began as the in-house system at Motorola. “We’ve done heparin Six Sigma, and it worked out very well,” Mr. Carlson said. “We reduced our heparin errors by about 70%, and we’ll probably be presenting on that at ASHP next year.” Eisenhower is directing specific efforts at “problem drugs.” “We maintain a list of high-risk, high-alert medications. For example, chemotherapy drugs have to have the calculation of the dose, as well as the dose as it’s made, double-checked by two pharmacists, as does any medication for a pediatric patient,” Dr. Matthews said. “Our smart pumps are programmed not to allow the dosage of dangerous drugs to exceed a certain amount, so you can’t accidentally ‘bump the button’ and boost the dosage from 10 mL to 100 mL. It’s important that we learn from others’ mistakes by continuously reviewing literature and published events of medication errors across the country. We are all capable of making mistakes which is why we are diligent in taking the right steps to prevent them from happening.” Although it is important to take care with high-alert drugs, the overall process must be improved, said Cathy Rosenbaum, PharmD, MBA, RPh, clinical effectiveness and safety officer at Bethesda North Hospital in Cincinnati. “Medication errors are all about process breakdown,” she said. “Very few health care professionals in general are trained to analyze process breakdown and do rootcause analyses and failure mode-effect analyses.” Dr. Rosenbaum suggested that all pharmacists should take a class, or a continuing medical education program, on process improvement, and that this element should also become an integral part of pharmacy education. “What are the quality tools? How do you do a flowchart of a process? How do you put together a multidisciplinary team to look see errors page 19

SPACE

needles, which he noted “was not possible before the Epidrum. This will have Among inexperienced operators— the advantage of reducing two importhose who had completed at most 40 tant complications that happen with epidural procedures—there were three epidural anesthesia: epidural hemafailed procedures among 89 patients in toma and dural puncture headache.” Manuel C. Vallejo, MD, profesthe Epidrum group; in the conventional group there were nine failed procedures sor of anesthesiology at the Univeramong 79 patients (P=0.046). This dif- sity of Pittsburgh School of Medicine, ference was not observed among the expressed concern that such a device might be bulky and awkward, and more experienced anesthetists. Dr. Hasan said his team is now work- that maintaining sterility could be a ing on reducing the size of epidural problem. Dr. Hasan, however, said CONTINUED FROM PAGE 15

that the device is single use and very lightweight. “It seems the device just magnifies the difference in using the hanging drop technique,” Dr. Vallejo said. “Although it may be innovative like the Episure device [Episure AutoDetect Syringe, Indigo Orb, Inc.], I am not so sure it will catch on in anesthesia practice.” The Epidrum device is approved for use in the United States and Europe. —Dave Levitan


18 I AnesthesiologyNews.com

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worldwide, and more than 400 publications have shown its value.

Q: Is the ROTEM FDA cleared?

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AnesthesiologyNews.com I 19

FEBRUARY 2011

TE CH N OL OG Y LINES

CONTINUED FROM PAGE 14

invasive line procedure and the physician attestation were present. As Dr. Nair reported at the 2010 annual meeting of the American Society of Anesthesiologists (ASA; abstract A381), documentation for all invasive lines rose significantly in the three months after he and his colleagues implemented the SAM system (P<0.05 for each individual line; Table). The results are comparable to those reported by Kheterpal and colleagues (Anesth Analg 2007;104:592-597) in their study of how to identify and improve compliance rates for documentation of perioperative arterial catheterization. In that study, if a case used an arterial catheter but no procedure note was observed, the resident or nurse anesthetist assigned to the case was sent an automated page and e-mail reminder. The study found that compliance improved from 80% at baseline to 98%, and projected a 12-month fee-reimbursement increase of $40,500. Robert E. Johnstone, MD, professor of anesthesiology at West Virginia University, in Morgantown, said that although screen popups on AIMS monitors attract attention, clinicians sometimes become inured to them. “I’d like to see the results of a longer trial, since people often learn to ignore notices and bypass extra steps while they complete the task at hand,” said Dr. Johnstone, vice president for professional affairs for the ASA. One limitation of such a system is that it will only work where an AIMS terminal can be found, Dr. Johnstone added. Many invasive lines are placed in critical care units or preoperative rooms, where AIMS terminals do not exist. What’s more, only about 10% of hospitals currently have an AIMS, although that number is growing. Dr. Johnstone applauded the researchers’ efforts, and noted that increased revenue of $145,000 is “not trivial.” But he said that using charge data, as the researchers did, rather than true collections could overstate the gains. Dr. Johnstone’s hospital, for example, collects only about $80 for an arterial line, less than it charges. “Even if other institutions successfully adopt this popup notification system,” he said, “they may not increase their collections as much as this study suggests.”

ERRORS

CONTINUED FROM PAGE 17

at root-cause analysis? Focus on the process, not a punitive person-based approach.” She also urged her colleagues to become more vigilant about datamining reports out of technologies such as smart pumps, scanners, robots and automated dispensers. “That’s pretty complicated and isn’t happening in most institutions yet. At least one pharmacist per institution

should be trained in how to datamine reports out of these various technologies and pull together analyses, and then share that information with nursing and physicians as well as pharmacists.” ISMP’s Take: Glass Half Full Despite the grim picture painted by the HHS OIG report and the NEJM article, much has been done to improve medication safety over the past decade, according to Michael Cohen, RPh, MS,

Closed.

ScD, president of the Institute for Safe Medication Practices. “There are many drugs and drug categories where [products] have been taken off the market, labels have been changed, and practices have been changed. People have worked hard and improvements have been made. We have a long way to go, but I don’t think we should lose sight of the progress that’s already happened.” —Gina Shaw

Open.

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C LIN I C A L A N ES THES IO LO G Y POISE

CONTINUED FROM PAGE 1

Dr. Mangano, one of the most vocal critics of POISE and a strong supporter of the use of β-blockers in the noncardiac perioperative setting, spoke about the issues at the 2010 PostGraduate Assembly in Anesthesiology. He later told Anesthesiology News of his concerns regarding the POISE study and the impact it has had on clinical practice, where it continues to play an influential role in guidelines and shape the overall discussion of the topic. Over Dose? Primary among the study’s problems, according to Dr. Mangano, was the dose of metoprolol given. The 8,351 patients in the study received either a placebo (n=4,177) or 200 mg of metoprolol per day beginning two to four hours prior to surgery and continuing for 30 days (n=4,174). Dr. Mangano said 200 mg is a far higher dose than should be given to most patients, although the study’s principal investigator pointed out that 200 mg is half the maximum daily therapeutic dose. During the 30-day follow-up period, fewer patients given β-blockers reached the primary composite end point of cardiovascular death, nonfatal myocardial infarction (MI) and nonfatal cardiac arrest (244 vs. 290 patients; hazard ratio [HR], 0.84; P=0.0399). Metoprolol Advertisement

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also reduced the incidence of MI overall, with an HR of 0.73 (P=0.0017) compared with the placebo group. The problematic result, however, was stroke incidence: 41 patients in the metoprolol group experienced a stroke, compared with 19 in the placebo group, for an HR of 2.17 (P=0.0053). In addition, more deaths occurred in the metoprolol group (HR, 1.33; P=0.0317). The POISE results were published in Lancet in 2008 (371:1839-1847). “I think that there is no doubt that there is a benefit to giving perioperative β-blockers: If you give them you prevent MIs,” said Philip J. Devereaux, MD, assistant professor of clinical epidemiology and biostatistics at McMaster University in Ontario, and the principal investigator on POISE, in an interview with Anesthesiology News. “At the same time, I think it is cavalier to look past the risks associated with perioperative β-blockers.” Dr. Devereaux said he agreed that the dose of metoprolol in the study was too high—in a sense. “People are 100% right. … The dose of β-blockers in POISE was too high for the benefit that we saw. It’s not worth it for the risk that we saw.” The question, he said, is whether a lower dose would give the same benefits while avoiding the risk. “I would put forward that no one has ever shown that,” Dr. Devereaux said. Previous studies have revealed the potential signal of higher risk for stroke, but only POISE had the patient population to reach statistical significance, he noted. Dr. Mangano said that the dosing in the POISE study also suffered from a lack of titration and variation; patients younger and older with varying degrees of sickness received the same dose. Yet, although patients with heart failure generally take no more than 25 mg of metoprolol to start, they received an initial dose of 200 mg in POISE. Arthur Wallace, MD, PhD, professor of anesthesia and perioperative medicine at the University of California, San Francisco, agreed that the dosing issues with POISE confound the conclusions on use of β-blockers in the study population. “If you had done a study where you had the wrong dose, you would conclude there is a therapeutic index for all drugs, and we clearly gave too much drug,” said Dr. Wallace, who has helped establish perioperative β-blocker programs in more than

150 hospitals. “They [the POISE authors] don’t conclude that. They conclude that β-blockers are dangerous and shouldn’t be used. Their conclusion is medically irresponsible and inappropriate. That’s the wrong conclusion. And that conclusion has harmed patients.” For his part, Dr. Devereaux argued that thorough titration of dosing in the millions of surgical patients is unrealistic, practically speaking, and that POISE’s counter-to-current practice results make it difficult for some experts to accept. ‘Startling’ Result “We have this result that has startled a lot of people. And the problem is that there have been experts in the area recommending β-blockers for 15 years prior to us doing POISE, and they clearly don’t like the results of POISE,” he said. “And neither do the POISE investigators. We wish we had hit a home run and showed no risk, but that’s not the reality.” Prior to POISE, the joint guidelines from the American Heart Association and the American College of Cardiology (AHA/ACC) for perioperative

use of β-blockers were based on small studies that did not adequately demonstrate a safe profile for the drugs, Dr. Devereaux said. Two of the most important of those studies, one by Dr. Mangano and colleagues published in 1996, had 200 patients (N Engl J Med 1996;335:1713-1721) and 112 patients (N Engl J Med 1999;341:1789-1794). Both showed significant benefit with the β-blockers atenolol and bisoprolol, respectively. Dr. Wallace said the latter study stopped at 112 patients only because the therapy’s success made it unethical to withhold β-blockers from some patients. As Dr. Devereaux pointed out, Dr. Mangano’s atenolol study also targeted 50% of the maximum daily therapeutic dose. John E. Ellis, MD, adjunct professor in anesthesia and critical care at the University of Pennsylvania School of Medicine, in Philadelphia, said the size of the POISE study makes it impossible to ignore. “The importance of POISE is that a lot of trials beforehand focused only on cardiac events, and POISE focused on everything,” he told Anesthesiology

General Guidelines for the Adoption of Perioperative Anti-ischemic Prophylaxis Arthur Wallace, MD, PhD, and his colleages at the University of California, San Francisco, offer the following “basic rules” for setting up a β-blocker protocol to reduce cardiac risk in perioperative patients. (Chart reprinted with permission.)

Patient Scheduled for Surgery With Coronary Artery Disease

Peripheral Vascular Disease

Two Risk Factors: • Age greater than 60 years • Hypertension • Diabetes • Cholesterol above 240 mg/dL • Smoking

Aortic stenosis Congestive heart failure Unstable angina New-onset angina Change in anginal pattern Angina without medical therapy Intra-coronary stent on platelet inhibitor

Refer to Cardiology

β-Blockers • Atenolol 25 mg PO QD to start, if heart rate greater than 60 and systolic blood pressure greater than 120 mm Hg. Titrate dose to effect. • Atenolol or metoprolol IV on day of surgery. Atenolol or metoprolol IV post-op until taking PO then. • Atenolol 100 mg PO QD for at least a week post-op (hold for heart rate less than 55 or systolic blood pressure less than 100 mm Hg). • If known CAD or PVD continue betablocker indefinitely.

If Unable To Take β-Blockers

If patient has a specific contraindication (asthma not COPD) to β-blockers: • Clonidine 0.2 mg PO tablet night before surgery • Clonidine TTS#2 Patch (0.2 mg/24 h) night before surgery

• Clonidine 0.2 mg PO table morning of surgery. • Hold for systolic blood pressure less than 120 mm Hg.

Proceed with Surgery


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CL IN ICA L A N E STH E SIOL OG Y News. “And POISE suggested that you reduce cardiac events but you increase stroke. That’s important to know. So if you’re trading benefit in one organ system for damage in another, that’s a problem.” However, Dr. Ellis said he agreed with some of the methodological concerns. “They gave too much drug,” he said. In addition, he noted that subsequent large trials in the Netherlands have not shown a risk for stroke with β-blockade begun and titrated in advance of surgery. “We’re naïve if we think we can have answers with just a couple of hundred patients,” Dr. Devereaux said. Proving that a lower dose would work as effectively and safely would require a large, blinded and randomized trial. Experts agree that such a trial would be very costly and is unlikely to be conducted in the near future. Don’t Ignore the Elephant in the OR Daniel Sessler, MD, professor and chair of the Department of Outcomes Research at the Cleveland Clinic in Ohio, agreed that overlooking POISE in favor of much smaller studies is dangerous. “Suppose there had been no benefit,” Dr. Sessler said. “The same people who now complain that the dose was too high would say that the dose was too low. There might be a dose that is both effective and safe. But you can’t just assume that such a dose exists. Until there is a randomized trial large enough to evaluate safety—one with many thousands of patients—clinicians should be very careful with perioperative β-blockers.” Dr. Wallace and his colleagues recently published an epidemiologic study in Anesthesiology (2010;113:794-805) of 38,779 operations performed at the San Francisco Veterans Administration Medical Center. They found significant reductions in 30-day and one-year mortality rates with the use of perioperative β-blockers. A pilot study suggested that starting a β-blocker more than two weeks prior to surgery could reduce the risks for cardiac complications and death substantially (American Society of Anesthesiologists 2010 annual meeting, abstract A781; see Anesthesiology News, December 2010, page 22). For the moment, the AHA/ACC guidelines continue to recommend that patients already on β-blockers—a group excluded in the POISE

study—continue taking the medication over the perioperative period. But recommendations are tempered for patients undergoing noncardiac surgery who have not been taking β-blockers. A class IIa recommendation deems it “reasonable” to give β-blockers “titrated to heart rate and blood pressure” in patients with high cardiac risk undergoing “intermediate-risk surgery.” The recommendations were updated after the POISE data were published,

reflecting the uncertainty generated by the large study’s results. “It was very destructive to a pretty clear, obvious, well-thought-out field of anesthesia that had a fundamental improvement of care,” Dr. Wallace said. Dr. Wallace went further, calling emphatically for a retraction of the POISE paper. “The average doctor doesn’t go through and look at this study in bitter detail.” Dr. Mangano agreed that the overriding effect among clinicians is most

likely confusion at this point. Based on impressions from anecdote, Dr. Ellis said that POISE has led clinicians to pull back on the use of β-blockers perioperatively. Is that justified? “I’m not sure,” he said. “I look at it like this in 2011: β-blockers are good for the heart, and they may be bad for the brain, particularly if you give too much. But there will continue to be controversy.” —Dave Levitan

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More Data Point to Possible Anesthesia-Cancer Connection The method of anesthesia has been found to affect the concentrations in blood of two molecules associated with angiogenesis in women undergoing surgery for breast cancer. The effect supports the hypothesis that a propofol/ paravertebral technique “may

The University of Texas MD Anderson Cancer Center in Houston.

PARAVERTEBRAL

CONTINUED FROM PAGE 1

that protects the mother and developing child from the rigors of general anesthesia, provides long-lasting postoperative pain relief, and may— if experimental evidence and results from animal studies prove true in humans—help prevent cancer recurrence. The key to a successful program, however, is a multidisciplinary approach and surgeon buy-in. “MD Anderson opened an outpatient surgery center a few years ago, where a high volume of our cases are breast cancer surgeries,” said Alicia M. Kowalski, MD, associate professor of anesthesiology and pain management at the institution. “We implemented paravertebral block to help control those patients’ pain.”

After an uneventful block, fetal heart tones were again obtained, after which patients were positioned for surgery with uterine displacement. Intravenous sedation (with or without propofol and/ or fentanyl) was provided throughout the operative procedure. Patients were brought to the postanesthesia care unit after surgery, where fetal heart tones were documented. All of the patients delivered healthy term infants.

provide serum conditions less conducive to angiogenesis and hence cancer metastases” than general anesthesia with opioids for pain, according to the researchers. (Tables adapted from 2010 annual meeting of the American Society of Anesthesiologists, abstract A013).

Table 1. Postoperative Pain Was Consistent in Patients Receiving General Or Regional Anesthesia General Anesthesia (n=20)

Paravertebral Block (n=20)

P Value

VAS pain score 2 h

3

1

0.007

VAS pain score 24 h

2

0

0.0393

VAS pain score 48 h

2

2

0.7619

RA; regional anesthesia; VAS, visual analog scale

Table 2. Serum Levels of VEGF-C and TGF-β Molecule

General Anesthesia–Pre

General Anesthesia–Post

P Value

Teamwork Key VEGF-C (pg/mL) 797±424 1,514±1,096 0.004 Performing successful blocks in 660±229 502±248 0.01 TGF-β (pg/mL) these patients depends largely on an interdisciplinary approach and highly TGF-β, transforming growth factor-β; VEGF-C, vascular endothelial growth factor-C trained regional anesthesiologists, Dr. Kowalski said. Skilled assistants are a must. Dr. Kowalski’s group uses specially trained holding-room nurses approach markedly increases everyone’s Although Dr. Kowalski found it who inject the local anesthetic after comfort level, she noted. hard to see any drawbacks to the “There was a big push-back in the regional approach in these women, the anesthesiologists locate the parabeginning when the anesthesiologists she noted that it requires 10 to 15 vertebral space. The First Case “We’re dependent on their insight, were first learning how to do the block minutes of additional preparation When a pregnant patient with breast reliability and expertise,” she said. Nurse and there were some delays,” said Henry time. “But the benefits of that extra cancer came to the clinic approxi- anesthetists also provide sedation. A Kuerer, MD, a surgeon who works 15 minutes are tremendous,” she mately three years ago, the clinicians gynecologic oncologist and breast sur- with Dr. Kowalski at MD Anderson. told Anesthesiology News. “I’ve had did not hesitate to use a paravertebral geon round out the team, although “Now the whole process is completely patients tell me their block lasted for a week.” block with sedation, thinking that gen- having surgeons endorse the anesthetic seamless.” eral anesthesia places both the mother and fetus at risk, particularly in the early Table. Paravertebral Block Cases at MD Anderson stages of the pregnancy when spontane- Patient Maternal Age Weeks Surgical Procedure PVB Fentanyl Propofol Inhalational ous abortion is a known complication of Number (Weight in kg) Gestation and Duration Levels (mcg) (mg) Agent exposure to general anesthetics. 1 35 y (NA) 23 Left total mastectomy T 1-6 400 “When she did really well, we did 36 y (73) 20 Left total mastectomy, left T 1-6 100 1,170 another similar case with the paraver- 2 lymphadectomy tebral block, then another and another.” 3 39 y (71) 20 Right total mastectomy T 1-6 75 1,300 <1.0 MAC desThe result was a case series of five flurane (over 20 patients, covering six procedures in all, min) that the researchers recently presented at 36 y (56) 18 Left segmental mastectomy/ T 1-6 100 630 the 2010 World Congress of the Seno- 4 intraoperative lymph node logic International Society, in Valencia, mapping/sentinal node biopsy Spain (Table). In each case, fetal heart tones were 5 30 y (53) 7 Right segmental mastectomy/ T 1-6 50 800 obtained before any patient intervention intraoperative lymph node was initiated. Intravenous access was mapping/sentinal node biopsy then obtained, and oxygen administered 5 30 y (53) 10.5 Redo right segmental Local 125 630 via face mask. With the patient in the (return) mastectomy sitting position, unilateral paravertebral MAC, minimal alveolar concentration block was performed at levels T1-T6.


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CL IN ICA L A N E STH E SIOL OG Y The most significant adverse event that patients face is pneumothorax, but Dr. Kowalski called the risk for that complication “exceedingly low.” Patients receiving the paravertebral block gain several benefits over their general anesthesia counterparts, including shorter recovery, less postoperative pain, fewer analgesics, less nausea and vomiting, and earlier hospital discharge.

‘There was a big push-back in the beginning when the anesthesiologists were first learning how to do the block and there were some delays. Now the whole process is completely seamless.’ —Henry Kuerer, MD

provide firm answers. Not only do Molecular Changes patients need to be enrolled, but the Point to Anestheticinvestigators must wait for sufficient Cancer Interaction An additional benefit of regional anesthesia was discovered by researchers at Mater Misericordiae University Hospital, in Dublin, Ireland. They examined the effects of anesthetic technique on factors associated with angiogenesis in 40 women with breast cancer. Patients underwent either general anesthesia with sevoflurane and opioid sedation or a paravertebral technique with propofol sedation (see box, previous page). The Irish team found that serum concentrations of vascular endothelial growth factor C (VEGF-C), which is active in angiogenesis and the growth of endothelial cells, increased postoperatively in patients undergoing general anesthesia. In contrast, patients who received regional anesthesia had no increase in VEGF-C after surgery. The study also revealed that levels of transforming growth factor β—which has an important role in tissue regeneration and regulation of the immune system—fell in patients receiving general anesthesia but rose in those receiving a paravertebral block (P=0.02). Whether these molecular changes are responses to inhalational anesthetics or supplemental opioids is unclear, but mounting evidence points to the possibility that analgesics may stimulate the growth of certain tumors. In 2002, researchers at the University of Minnesota showed that morphine spurred the growth of human breast cancer cells grafted into mice. Although research is ongoing, few studies have been able to show this relationship in humans, something that anesthesiologist Daniel I. Sessler, MD, of the Cleveland Clinic, in Ohio, is trying to change. The Outcomes Research Consortium, directed by Dr. Sessler, is conducting three large randomized trials testing the hypothesis that regional analgesia combined with general anesthesia reduces cancer recurrence compared with general anesthesia and opioid analgesia. The group is evaluating cancers of the breast, lung and colon. Dr. Sessler predicted that it will be many years before the studies

cancer recurrences, which can take years. Meanwhile, he strongly recommended that anesthesiologists not

change their practices based on the theoretical benefits of regional analgesia on cancer recurrence. “The possibility that regional analgesia reduces the risk of cancer recurrence is an intriguing theory, but it remains a theory at this point,” Dr. Sessler said. “The basic science and animal evidence suggest that these potential benefits are worth investigating, but the limited data we have in humans so far is at best equivocal.” —Michael Vlessides


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Before Resorting to Surgery, Consider Nucleoplasty for Disc Herniation

N

ucleoplasty can relieve pain and improve quality of life for many patients with herniated discs as well as or better than conservative management, a new review has found. Herniation resolves within weeks to

months with no treatment in at least 90% of cases. But when anti-inflammatories and steroids—both oral and injected— fail, surgery often follows, raising the specter of potentially serious complications for patients. “There are a variety of interventions

that have their place between conventional conservative measures and surgical treatment,” said Dmitri Souzdalnitski, MD, PhD, a pain medicine fellow at the Cleveland Clinic in Ohio. “Nucleoplasty is one of them.” Nucleoplasty also might help keep patients with chronic pain

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from becoming part of the “epidemic of opioid prescriptions,” he added. Dr. Souzdalnitski and his colleagues analyzed three previously published studies of nucleoplasty, or plasma disc decompression, for herniation. Dr. Souzdalnitski presented the results at the 2010 annual fall meeting of the American Society of Regional Anesthesia and Pain Medicine, in Phoenix (abstract 50). The studies, totaling 275 patients, showed that pain scores were lower after nucleoplasty compared with conventional management for a period of two to six months. Based on the two most recent studies, both of them randomized trials, the researchers found the approach improved pain scores in three months by about 22% more than traditional treatments (P<0.01). Patients receiving nucleoplasty reported reductions in pain of an average of five points on a 10-point scale. “Nucleoplasty might be less invasive than surgery, and it may provide more long-lasting effects than steroid injections, which don’t seem to last very long,” said Roger Chou, MD, associate professor of medicine at Oregon Health & Science University, in Portland, and director of clinical guidelines development for the American Pain Society. But Dr. Chou expressed some concerns. One of the studies was not randomized, while the other two were randomized but not blinded, which could exaggerate the estimated benefit. He also pointed out that the trials addressed different conditions: cervical and lumbar disc herniations. “These conditions are really not the same, and in my opinion, it’s not appropriate to combine the results,” he said. Furthermore, none of the studies compared nucleoplasty with surgery, and the study that compared nucleoplasty with an epidural steroid injection included people who already had failed that treatment. These patients might have been unlikely to respond to another injection, Dr. Chou said. Although the poster did not address safety, Dr. Chou found no significant differences in his earlier review of back pain interventions (Spine 2009;34:10781093). The investigators agreed that additional research is needed to determine long-term benefits and risks. “We have to be more proactive in exploring and applying new targeted treatments for pain as opposed to unjustified prescription of opioids for chronic back pain,” Dr. Souzdalnitski said. —Lynne Peeples


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CL IN ICA L A N E STH E SIOL OG Y

Cases Suggest Promise of Intrathecal Morphine for Hypothermic Circulatory Arrest

Although the researchers acknowledge that extrapolating from two patients is difficult, Dr. Kulkarni said that she has continued her research with an additional 15 patients and is seeing similar results. “With pain conIn his recent systematic review, Martin trol being the fifth vital sign these days,” ntrathecal morphine may provide after surgery. No side effects were observed in the Tramer, MD, DPhil, professor of anesthe- she said, “intrathecal morphine may be a new strategy for minimizing pain, intubation time and their associated two patients, but a few additional risks can siology at Geneva University Hospitals, in a very satisfactory strategy for patients complications in patients undergoing aor- be associated with intrathecal morphine, Switzerland, found that the injection can undergoing circulatory arrest and deep tic surgery involving deep hypothermic cir- Dr. Kulkarni noted. Epidural hematomas lead to rare but serious cases of respiratory hypothermia.” have been known to occur with the treat- depression and frequent but minor cases culatory arrest. of pruritus. “Intrathecal morphine has been shown to ment, he added. —Lynne Peeples be an effective means of pain control in coronary artery bypass surgery, but not yet in this setting,” said Rama Kulkarni, MD, clinical associate professor of anesthesiology at the University of Florida, in Gainesville. Drs. Kulkarni and colleagues decided to investigate whether the benefits transferred to the more complex aortic surgery. Based on the outcomes of two patients undergoing deep hypothermic circulatory arrest for complex aortic root reconstructions, 0.6 to 0.7 mg of intrathecal morphine injected into the L2-L3 interspace before surgery appeared to control postoperative pain. The intervention decreased the need for postoperative intravenous narcotics, and therefore reduced respiratory depression and sedation. Neither patient requested narcotics during the first 24 hours after surgery, according to the researchers, who reported the cases at the 2010 annual fall meeting of the American Society of Regional Anesthesia and Pain Medicine, in Phoenix (abstract 70). (Both patients received 2 mg of IV morphine as well as oral narcotics during the second day.) Dr. Kulkarni suggested that intrathecal morphine also might curb use of narcotics during surgery, leading to an earlier wakeup and faster extubation. One patient received no supplemental narcotics during surgery; the other received 100 mcg of fentanyl. Intraoperative heparin was administered two hours or more after the intrathecal puncture. “There’s always a push to get a patient extubated early so that intubation-related complications can be minimized, particularly in the setting of deep hypothermic circulatory arrest, which requires a patient to endure prolonged periods of intubation,” Dr. Kulkarni said. Within 24 hours of admission, both patients had been extubated and had begun ambulating and receiving nutrition orally. “In addition to a fast recovery, the strategy appears beneficial in terms of nurse, patient and family satisfaction, as well as a shorter length of stay in the intensive care unit and the hospital, which could translate into lower costs,” Dr. Kulkarni said. One of the patients went home four days

I


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Beware of ‘Hidden’ Artery in Cervical Radiofrequency Neurotomy

T

he common perception that no vulnerable structures lie in the target region for a cervical radiofrequency (RF) neurotomy may be mistaken. Anesthesiologists at Ohio State University Medical Center, in Columbus, came across a lesserknown blood vessel while performing the procedure. The intervention triggered a frightening case of temporary

blindness that prompted A. Raj Swain, MD, assistant professor of anesthesiology, and his colleagues to report the case at the 2010 annual fall meeting of the American Society of Regional Anesthesia and Pain Medicine in Phoenix (abstract 26). “The deep (ascending ) cervical artery can lie in the middle of the target zone,” Dr. Swain said. “This artery

is not frequently discussed in the literature, but the vessel is present.” The artery anastomoses with the occipital artery, which supplies the occipital lobe, explaining why the patient lost sight (Figure 1). His vision returned within five minutes. The patient had presented with chronic axial neck pain and headache, reproduced with cervical facet

loading. To determine if he was a candidate for RF neurotomy, the patient underwent medial branch nerve block from C2 to C6. The diagnostic procedure was successful and the patient was scheduled for RF neurotomy. Dr. Swain and his team began the procedure by setting a RF ablation needle at the C2 articular pillar (Figure 2). After positive sensory stimulation, as well as negative motor stimulation and negative aspiration, they injected 0.5 mL of 0.25% bupivacaine. The team immediately was alarmed by Occipital artery

External carotid artery

Pharyngeal branches, subclavian artery

Ascending cervical Vertebral artery artery

Figure 1. The deep cervical artery lies behind the vertebral artery and along the cervical articular pillar, which can also be the middle of the target zone for cervical radiofrequency neurotomy.

Figure 2. Doctors advanced the radiofrequency needles under fluoroscopic guidance to the midpoints of the articular pillars at C2 and C5. This procedure is assumed to be safe because no vulnerable structures lie in the intended track of the needle.


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CL IN ICA L A N E STH E SIOL OG Y the sight of bright red blood in the needle and a panicked patient who could not see. The procedure was aborted and the patient taken to the postanesthesia care unit. “Negative aspiration doesn’t mean you aren’t in a blood vessel,” Dr. Swain said. “You need to be vigilant and pay very close attention to the patient.” Hitting the vessel is unlikely to cause permanent damage, he said, but a grand mal seizure is possible. “Any time you inject any local anesthetic into the Hospira Halts Production of Thiopental Death penalty politics has claimed an anesthetic agent. Hospira announced in January that it would stop making the anesthetic thiopental (Pentothal). The drug has been a component in the drug cocktails used by 35 states for chemical executions. Hospira had planned to shift production of thiopental to Italy because of manufacturing problems at the North Carolina facility where it had been making the agent. But Italian officials wanted assurances that the drug would not be used for lethal injections. Although Hospira said it “never condoned” the use of thiopental in executions, the company determined that it could not prevent corrections departments in the United States from obtaining the drug. “Based on this understanding, we cannot take the risk that we will be held liable by the Italian authorities if the product is diverted for use in capital punishment,” Hospira said in a statement. The American Society of Anesthesiologists (ASA) released a Jan. 21 statement condemning the decision. ASA “certainly does not condone the use of sodium thiopental for capital punishment, but we also do not condone using the issue as the basis to place undue burdens on the distribution of this critical drug to the United States. It is an unfortunate irony that many more lives will be lost or put in jeopardy as a result of not having the drug available for its legitimate medical use.” According to ASA, thiopental has been an important alternative for geriatric, neurologic, cardiovascular and obstetric patients “for whom the side effects of other medications could lead to serious complications.” —AN Staff

cervical vasculature—even just a tenth of a milliliter—you can provoke a seizure.” Injection of a steroid could have led to even worse consequences, including a stroke, according to Steven Cohen, MD, director of pain research at Walter Reed Army Medical Center in Washington, D.C. However, in general, cervical medial branch blocks and RF are extremely safe procedures, he said. “This just shows us that they are not risk-free.” Dr. Cohen added that whereas a local

anesthetic can decrease the pain associated with a heated needle and enhance lesion size, it is not necessary for the procedure. If a decision is made to go with the anesthetic, he suggested using contrast dye under real-time fluoroscopy to ensure clearance from any blood vessels. “It’s not perfect,” he said, “but, it’s better than relying on aspiration.” Dr. Swain said he preferred to avoid using the contrast dye because it can obscure the picture of subsequent joints during the procedure. He said to

lessen the risk for hitting a vessel, a viable alternative may be to use a blunt-tip needle. However, this technique is not problem-free as it can be both more difficult to maneuver and more painful for the patient. Whatever the technique used, Dr. Swain advised to “be aware of vascular anatomy, and do not have a false sense of security that you’re no where near an artery.” —Lynne Peeples

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C LIN I C A L A N ES THES IO LO G Y During antegrade cerebral perfusion …

anesthesiology medical director at the institution. “With this strategy, however, we’ve found that children had a high incidence of low cerebral saturation in the early postoperative period, which has been shown to be associated with cerebral injury.” The observational study conducted “We, and others, have shown that San Diego—Modifying cardiopul- contributed an additional strategy to monary bypass strategies during com- the list; the researchers found that cere- antegrade cerebral perfusion [ACP] by Dr. Hoffman and colleagues examplex aortic arch repairs has become bral autoregulation appears to be better utilizing a pH-stat strategy at rela- ined the effects on cerebral oxygenation well accepted in the prevention of preserved by a modified pH-stat strat- tively high flow rates [50 mL/kg per and vasoreactivity, postoperatively, ischemic cerebral injuries in pediatric egy that avoids prolonged exposure to minute] can produce high cerebral when blood-gas management was varpatients. A study at the Children’s Hos- very hypercapnic conditions during oxygen saturation during the support ied during ACP. Dr. Hoffman reported time,” said George M. Hoffman, MD, the findings at the 2010 annual meetpital of Wisconsin, in Milwaukee, has antegrade cerebral perfusion. ing of the American Society 6 of Anesthesiologists (abstract 24 pH strategy on ACP pH strategy on ACP A200). 22 standard pH-stat standard pH-stat 5 Enrolled in the study were modified pH-stat modified pH-stat 20 23 infants undergoing staged 4 palliation of hypoplastic 18 left heart syndrome with 16 3 an innominate-pulmonary artery shunt. The patients 14 received high-dose opioids 2 12 and isoflurane-balanced 10 anesthesia while undergoing 1 30 40 50 60 surgery: high-flow cardiopulICU hrs 1-12 ICU hrs 13-24 ICU hrs 25-36 ICU hrs 37-48 monary bypass (CPB) using pCO2(torr) Time period phenoxybenzamine, cooling to 20 C, and ACP at 50 mL/ Figure 1. Differences over time in cerebral Figure 2. Postoperative cerebral autoregulation: kg per minute with a pH-stat arteriovenous oxygen content by ACP strategy. CO2 reactivity. strategy that targeted at least ACP, antegrade cerebral perfusion; CI, confidence interval; PCO2, partial pressure of ACP, antegrade cerebral perfusion; CPB, cardiopulmonary bypass; ICU, intensive 85% cerebral oxygen saturacarbon dioxide care unit tion during ACP. Predicted values and 95% Cl for darSO2C

Ba St seli a n En rt A e C Po d C P st PB CP B

Cerebral a-v O2 diff. cc/dL

Modified Strategy for Saturation May Avoid Ischemic Injury

Anesthesia Method Matters for AV Fistula Repair San Diego—Results of an ongoing pilot study show that patients who receive regional anesthesia for surgery to repair an arteriovenous fistula have better outcomes than do similar patients given general anesthesia. The researchers, from Duke University School of Medicine, in Durham, N.C., found that patients who received nerve blocks were nearly five times as likely to have a successfully repaired fistula as those who underwent surgery with general anesthesia. “In general, there are three ways to provide anesthesia for arteriovenous fistula surgery: general anesthesia, regional anesthesia and sedation,” said Tong-Joo Gan, MD, vice chair of anesthesiology and clinical research at Duke, who helped conduct the study. “Increasingly, we find ourselves using regional anesthesia because of the immediate postoperative benefit in terms of less pain and few opioidrelated adverse effects. However, there may be longer-term benefits of regional anesthesia.”

A retrospective study revealed that patients who have regional anesthesia for arteriovenous fistula repair also have a higher success rate six months after surgery, Dr. Gan said. So his group decided to perform their pilot study to further analyze the technique. The study included 16 patients randomized to receive regional (n=9) or general anesthesia (n=7); all were premedicated with 50 to 100 mcg of fentanyl and 2 to 3 mg of midazolam. Patients who received regional anesthesia underwent supraclavicular brachial plexus block with an initial bolus of 30 mL of 0.5% ropivacaine, followed by a continuous infusion of 0.2% ropivacaine (5-10 mL per hour for 48 hours). Seven of the patients who received nerve blocks (78%) were considered to be successes, compared with three patients who underwent general anesthesia (43%), yielding an odds ratio of 4.7 (P=0.30). “This is a pilot study and is not

designed to have adequate power to demonstrate a difference between regional and general,” Dr. Gan said. “However, the results so far showed a remarkable trend in favor of regional anesthesia in the success of long-term fistula function. If a similar trend continues, we are likely to show statistical significance within the scope of the study.” Better Outcomes, Less Pain In addition to greater success with fistula function, patients given regional anesthesia also had significantly less pain in the early postoperative period and required fewer opioids during and after surgery than did those in the other group. “Clearly this is of clinical importance, because the failure rate of fistula access surgery is pretty high,” said Dr. Gan, whose group presented its findings at the 2010 annual meeting of the American Society of Anesthesiologists (abstract A1262). “And if anesthetic technique can affect these

outcomes, then we need to think about which technique to use. However, this is a very small sample size and we need to be cautious when interpreting these early results.” Future research will focus further on the mechanism of the improved fistula function. “Regional anesthesia appears to show significant promise in improving pain control,” Dr. Gan concluded. “But more important are the long-term outcomes, which are certainly more speculative, but we are going to explore nonetheless.” Senthilkumar Sadhasivam, MD, MPH, director of the acute and perioperative pain service at Cincinnati Children’s Hospital Medical Center, in Ohio, said he was encouraged by the study results. The Duke researchers “have good pain control and less morphine procurement, both of which are beneficial,” Dr. Sadhasivam said. “The randomized research design and six-month follow-up are other strong aspects” of the study. Yet, Dr. Sadhasivam was not


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CL IN ICA L A N E STH E SIOL OG Y Using temperature-uncorrected blood gases (Pco2 at the end of ACP), the resulting strategies were categorized either as modified pH-stat (Pco2<55; n=12) or standard pH-stat (Pco2≥55; n=11). The researchers found that the only difference in Pco2 management between groups came at the end of ACP (45±13 torr vs. 66±20 torr; P=0.034). The difference in cerebral arteriovenous oxygen content (approximated by near-infrared spectroscopy) was lower in the early–post-CPB period (Figure 1). No difference in early postoperative hemodynamics was observed between groups. “There were no differences in the mean cerebral oxygen saturation,” Dr. Hoffman said, “but, there were differences in cerebral autoregulation as defined by the relationship between cerebral saturation versus Pco2 and versus blood pressure” (Figure 2). “At constant blood pressure, the effect of carbon dioxide on cerebral saturation was significant in the modified pH-stat group only,” he said. “Furthermore, the effect of blood pressure on cerebral saturation at constant Pco2 was seen only in the standard pH-stat group.” When adjusted for these covariates, the modified pH-stat group demonstrated slightly higher cerebral saturation, postoperatively.

convinced of the long-term benefits of using regional anesthesia in patients undergoing arteriovenous fistula surgery, primarily because of the trial’s small size and lack of adequate power to show statistical significance. “I think if they continue the study to show long-term benefits in a relatively large sample, the study has the potential to change the way we practice anesthesia in arteriovenous fistula patients,” he said. Dr. Sadhasivam noted that at his institution, surgeons regularly achieve success rates of 65% to 70% for arteriovenous fistula repair using general anesthesia, much higher than the 43% achieved in the trial. “That is another reason why I’m not convinced yet,” he added. “It would be good to know the complications, if any, with supraclavicular blocks—such as pneumothorax—and the experience level of the staff performing blocks, to assess feasibility for other centers and to identify alternative regional anesthesia techniques for arteriovenous fistula [repair] at different levels.”

This study highlights the interaction between intraoperative management and postoperative physiology, demonstrating that postoperative cerebral vascular resistance is affected by pH strategy during CPB and ACP. Dr. Hoffman said that, based on the effects of CO2 and blood pressure on cerebral saturation, a modified pHstat strategy appears to better preserve cerebral autoregulation compared with avoiding prolonged exposure to very hypercapnic conditions during ACP.

“Measuring and targeting cerebral saturation may allow safe modification of management strategies to avoid cerebral injury,” he said. Hilary P. Grocott, MD, professor of anesthesia and surgery at the University of Manitoba, in Winnipeg, said that the debate between alpha-stat and pH-stat blood-gas management in complex pediatric cardiac surgery appeared to have been put to rest long ago, with pH-stat management overwhelmingly being adopted. “What Dr.

16th Annual Update on Cardiopulmonary Bypass

Hoffman and colleagues have now demonstrated, however, is [that] there is perhaps room for compromise,” Dr. Grocott told Anesthesiology News. “Their modified pH-stat approach— with less extremes of hypercapnia— appears to offer a significant benefit to the brain, though definitive proof will have to wait for randomized trials examining clinical functional end points.” —Michael Vlessides

33rd Annual Meeting & Workshops

March 6 - 11, 2011

Society of Cardiovascular Anesthesiologists

—Michael Vlessides

www.scahq.org


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criminal activity. My lawyer did not understand the charge “Medicaid fraud” and kept calling it “medicated fraud,” which, considering that I was narcotized during the commission of the crime, was painfully accurate. I had to continually correct him. The attorney said that an application for citizenship would probably trigger extradition proceedings. So, with citizenship out of the question, I left Israel for Egypt. I enrolled in a course for teaching English as a foreign language, through a program called the Royal Society of Arts University of Cambridge Local Examination System. The title sounds more impressive than it deserves, but it landed me a teaching position at the American University in Cairo. The work covered my expenses and I found a source of extra income from an investment property back home that began paying me a little bit. (The state of Michigan had appointed a receiver for the funds of my corporation, but my personal assets were unaffected.) Teaching at the American University was rewarding, fun and creative. I must have had some talent for teaching because I was offered a potentially lucrative position with a junior college accredited in the United States. But the school checked police records, so I turned down the offer without applying. Although my economic situation was stable, Egypt was much different from what I was used to—especially social relations with the locals, which were uncomfortable at best. Yet the country then had no shortage of expatriates, and the various groups had created close-knit and nurturing communities for themselves. Nearly every long-term ex-pat was running from something or someone, and I found them to be as nonjudgmental as the recovering addicts I’d met before.

Caracas It became clear to me that I was never going to incorporate myself into the local culture, so I began to consider another move. An acquaintance suggested I look at South America, and this idea made sense. I’d traveled extensively in South America and spoke a smattering of Spanish. I bought a ticket to Venezuela and touched down in Caracas on July 29, 1992. The heat was overwhelming at Simon Bolivar Airport, only a few hundred yards from the Caribbean, but Caracas is about 20 miles inland at an elevation of more than 2,000 feet and considerably more pleasant. Within a week, I had found work and was taking Spanish courses to improve my fluency. I found a comfortable room that was close to the subway station and a shopping center. With help from a family member whom I thus far had failed to alienate I purchased a nice apartment in a middle-class neighborhood. I had friends, a job and a new life. I was teaching English as a foreign language, mostly peripatetically. Eventually, I opened a small brokerage company dealing in veterinary pharmaceuticals. Revenues were very high for a while, and I was making an excellent living working no more than about 15 hours per week. Naturally, I thought there wasn’t an end to it and I had no plans in case this new, good life stopped. I had enough money to travel, and travel well, so I bought a business-class ticket for a round-the-world trip. My stops included visits to Amsterdam, London, Rome, Vladivostok, Seoul, Sidney, Easter Island and more before finally returning to Caracas. Work along the way took maybe five hours per week from my vacation time. In 1998, my countrymen elected a new president, Hugo Chávez. At first I wasn’t really concerned about Chávez. I had become a Venezuelan citizen, what they call a “reencauchado,” a retread, like a tire. Then a few things started to

The state is responsible for providing health services at a level consistent with care available to the general population—a comparison most of us behind bars felt was far from being met. The need to get permission to institute chemotherapy and an efficacious pain medication regimen does the work of the grim reaper; the consistent refusal of the state to commute the sentences of seriously ill nonviolent offenders does so, as well.

The American University of Cairo (image courtesy of the American University of Cairo).

happen: changes in the tax structure, recall elections, general strikes. People who had lived as expatriates in Venezuela for 20 and 30 years began to leave. The usual scheme of institutionalized bribery—“matraca”—became more onerous. Taxes now were demanded on external earnings and the collectors watched every cent you paid. When you went to a store to buy a loaf of bread or a candy bar, you had to present your national identification number. I started to think of leaving and began to put larger amounts of money into my offshore account. I looked for business opportunities with government connections and eventually landed one—a contract for single-piston tractors with a large variety of implements—that suited the goals of the government and paid quite handsomely. But the discussions and bribes were unrelenting and the expenses were ridiculous. One night, I was presented with a $5,000 bar bill. I don’t think I drank that much liquor in my life. Members of the Guardia Nacional had to be bribed. Before Chávez, you had to pay the tax or the bribe; now you had to pay both the tax and the bribe. I wanted out. Meanwhile, all the bribes had been eating away at my large offshore reserves. I went belly up. No more savings, my business ruined. I sold my apartment in Caracas in a market that was severely depressed by the political situation. Much of the proceeds went to defray debts. I was rapidly losing my means to remain a fugitive. It was 2005; I had been in hiding for more than 15 years. I held two passports— American and Venezuelan—and had no difficulty crossing borders. I had done so at least 175 times without trouble. I did have contacts, but due to the downturn in business in Venezuela,

none were hiring. Even places as remote as El Tigre in the northeastern state of Anzoátegui were becoming attractive to me, but there was no call for a full-time teacher. There were some low-paying jobs in provincial schools of the “English as she is spoken” variety, but none of these paid well enough. I moved to Margarita Island, off the coast in the Caribbean, and took a fairly comfortable apartment in Porlamar, but I was spending too much of my meager remaining funds and making none. Home In the back of my mind, I recognized that I had to return to the United States to face my prison sentence in order to start over. So one day in 2006, I bought a plane ticket to Miami. I expected to be arrested on the spot as I went through customs. But in the post-9/11 era, I guess they weren’t interested in me. I was questioned only about a Colombian poncho, or ruana, that I was wearing, but it was quite old and not subject to duty. Friends picked me up at the airport and put me on a bus back to Michigan. When I arrived at the depot, other friends picked me up and kept me hidden until my surrender had been negotiated. I often wonder about the necessity of that. I was never charged with crossing a state or international boundary in order to avoid incarceration. I never did learn why: Perhaps arrest lists concern categories of individuals other than myself, or the warrants for me had expired or there was no proof that I had crossed international borders. Or maybe they just didn’t care; if an individual returns voluntarily (as opposed to being extradited), the state often forgives the exit. My delinquent child support was not an issue, either. It seems


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PR N that my forfeited surety bond was used to settle the outstanding payments. Several aspects of my incarceration had changed since I fled. The state no longer had a community residential placement program, so getting out after 19 months was no longer possible. On the other hand, Michigan made an allowance for “good time” when I was sentenced. As a result, my fiveyear minimum became 43 months. Of course, you can—and usually do—lose good time, and the prison system has no problem holding inmates for longer than their minimum terms. Ironically, when I returned to the United States, sentencing guidelines existed for the charge of conspiracy to commit Medicaid fraud. The maximum term was far shorter than my original sentence, which had been the most allowed at the time of my original sentencing. On entering the prison system, everyone is sent to quarantine for intake and assignment to a security level. Level 1 is the most lenient; level 6, the most structured. The most palpable differences are supposed to be the length of time that inmates are allowed “yard” and the hour of “lights out.” These standards seem to be arbitrary, and often the lights-out time varies between facilities even for the same security level. ‘The Fish’ Prisons are inhabited mostly by repeat offenders who are familiar with the ins and outs of their particular facility and the larger system. I was, of course, the “fish,” having no prior prison experience. It took me two days to figure out how to open my cell when the brakeman opened the tiers. The guards (now called “COs” for “correctional officers” or “cops”) were cool to the notion that a prisoner didn’t know how to open his cage. After that stormy introduction, I was introduced to the notion of prisoners in nicotine withdrawal. This occurred on the morning of the second day when an inmate in obvious withdrawal confronted me with a demand for a cigarette. I hadn’t smoked tobacco since the Johnson administration, but the overwhelming majority of prisoners and their jailers are heavy smokers. I was initially classified to security level 2, because I had more than three years of my sentence remaining. The fact that I was in level 2 permitted me contact with murderers. The educational level of prisoners is abysmal at best. Most are dropouts from elementary or high school. Some are uneducable. I realize that this term does not fit in with current theories, but

the system does encourage prisoners to obtain their general education diplomas (GEDs) and I met many inmates who were unable to do so in the course of 14 years or longer. The opportunity for education does exist, but it’s beyond the capability of most prisoners. Whether the barrier is financial or intellectual, I can’t say. In one instance I was transferred by my own request to a housing unit to be a tutor. Of the 140 prisoners in the unit, only one had graduated high school or

had a GED. Prison lore has it that educational and vocational opportunities used to be more plentiful, but the programs were discontinued because they made former prisoners more competitive than the general population. I cannot confirm or refute this belief. The most valuable commodity in prison is information—rather, accurate information, as misinformation is readily available. The rumor mill of “yard talk” is pervasive and resembles a child’s game of “Telephone.” A prisoner

generally hears a news report that may be truth or opinion but is taken as fact, circulated (although not before being distorted) and within a few oral reports rendered completely valueless as information, yet considered iron-clad. As a physician, I was several cuts above the educational norm for inmates. Within a few days of my landing in any prison, the guards and most of the prisoners invariably knew who I was and why I was there. The prisons in see juggernaut page 32

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Michigan had a computerized look-up Web site for inmates, and the guards were always curious about their charges. Many prisoners were notorious for several reasons, most of them unsavory. My personal acquaintances included a man who had stabbed a little girl 14 times “because she laughed at me.” Also a man who tied a little boy to a tree and repeatedly raped him, and a pair of repeat child molesters and murderers of various stripes. My prison had no permanent psychiatric facility. When problems arose, the inmate was sent elsewhere for diagnosis and the initiation of drug therapy and returned to the general prison population. When the problem recurred, the inmate would be referred again for assessment and dosage calibration. The man who stabbed the girl not only was mentally ill but had a depression on his scalp with a “U” shaped incision around it where a burr hole had been drilled to relieve an internal hydrocephalus. Therefore, not only did he have functional mental problems but organic neurologic disease as well. He served his term and was discharged having received no definitive treatment— but not before assaulting at least one fellow inmate a month, including me. But the system can be a comfortable one as soon as you are in a stable Advertisement

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position. The worst days are those of intake and movement always the most confusing and exhausting. I was in only four different facilities including quarantine. Typically, the facility in which you are housed determines the possibility of obtaining “major misconducts” and hence the term of incarceration. As far as personal liberty in levels 5 and 6, prisoners are housed in individual cells and restricted to them—about 22 hours a day in level 5 and 24 hours a day in level 6. In the uppermost levels, inmates are shackled and escorted every time they leave their cells. In the lower levels there is some freedom of movement, although within strict boundaries. Prisoners are constantly reclassified with respect to their security level based on the number and nature of major citations they receive. Citations related to assault are a good way to earn a bump up in security level. I had a bunkie (in prison, the words roommate, cellmate and bunkmate all imply a homosexual relationship) who was “down” for attempted murder. He was the most benign individual I met during my incarceration. He’d had a much older lady friend who had jilted him for a new lover. My bunkie had threatened the man and used a pistol to cover his escape. In France, he would have been a national hero. He happened to be a brittle diabetic for whom the slightest change in dosage of insulin or diet could have dire consequences. He was constantly going into comas with blood sugars down in the 20s, and many times I had to pour glucose down his throat. He required dialysis and his condition was deteriorating, but in my opinion as a physician his care was shamefully poor. I considered many other aspects of health care in prison questionable at best. The provider is a subcontractor for the state and receives more than $100 million a year to provide health services to inmates, many of whom are young, healthy and make no visits at all to the clinic with the exception of the mandatory yearly check-up. That means that the provider receives more than $2,000 a year for each of the 46,600 inmates in the state system. Never in my greediest, narcotic-induced fantasy could I bill that much for annual medical services. Yet the state doesn’t question it. But the state is responsible for providing health services at a level consistent with care available to the general population—a comparison most of us behind bars felt was far from being met. The need to get permission to institute chemotherapy and an efficacious pain medication regimen does the work of

Caracas, Venezuela

the grim reaper; the consistent refusal of the state to commute the sentences of seriously ill nonviolent offenders does so, as well. ‘Good Time’ Work is a dominant aspect of daily life in prison. The system assigned me to work as a janitor, a position for which I had specifically not applied for medical reasons. When I couldn’t perform the job because of overwhelming pain, I received two major misconduct citations and was restricted to my cell. The warden also rescinded about 80 days of good time, effectively lengthening my prison sentence by the same amount. I went to a physician at the health service and wrote down all of my physical problems—Crohn’s disease, diabetes with diabetic neuropathy, traumatic arthritis of the right femur, moderately severe osteoarthritis of the spine and a few other problems such as a cataract of the left eye, hearing impairment and chronic sinusitis. I asked him for a light duty detail as that would have resolved the major citations. The physician said he believed every word I said but he refused to reassign me. I wrote a grievance and the grievance coordinator suggested that I be examined by a paramedic to determine if I was fit for the assigned job. I thought that was a very reasonable approach but the physician refused. I received more time after a run-in with a different bunkie. He had threatened repeatedly to kill me because my

flatulence from Crohn’s disease was disturbing him. Taking him at his word— he was a lifer who had been on the street for a total of seven months in his adult life—I refused to return to my cell. I was sent to solitary confinement for nine days, after which I was moved to a different cell. Sometime later, my exbunkie attacked his new roomie with a lock-in-a-sock—the prison equivalent of a medieval mace or morning star—and received an additional sentence of 10 years. On another occasion, I left the barracks when the count light went out and was stopped by a guard. He issued me an out-of-place citation that took away another 45 days of good time. I received yet another ticket when a cubie (cubies are inmates who are housed in six-, seven- and eight-man cubes) stole my Bentyl and I didn’t have the requisite number of pills on inspection. Bentyl contains an anticholinergic that makes users believe they are in some way stoned but would be totally worthless as a drug of abuse outside the prison system. Inmates can appeal citations to circuit court, but the expense is more than most prisoners can afford and the court does not waive its fees, although it will take partial payments. However, you can’t appeal a new citation when there is a balance remaining on a previous citation appeal. Overcrowding in noncorrectional settings is dangerous, but in situations where people are on the fringes of

The bribes were unrelenting and the expenses were ridiculous. One night, I was presented with a $5,000 bar bill. I don’t think I drank that much liquor in my life. Members of the Guardia Nacional had to be bribed. Before Chávez, you had to pay the tax or the bribe; now you had to pay both the tax and the bribe.


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PR N normal or are patently abnormal, it can be lethal. States have standards for separating violent and nonviolent prisoners, but I observed inmates moving rapidly up and down the scale of aggressive behavior based on their performance. Inmates have the right to freedom of speech and other expressions, but those who speak out too loudly or advocate too well sometimes receive “diesel therapy.” Diesel therapy is the practice of moving inmates who incur the displeasure of the administration from facility to facility, barely allowing them time to unpack before being moved on to another prison. I should add a word about homosexuality in prison. Sex, or usually the lack of it, is a dominant theme for inmates. Homosexuality, however, is relatively common. When it does occur the vast majority is consensual, in fact if not in law (prisoners cannot legally consent to sexual relations). Prisons are full of transsexuals, homosexuals and other non-heterosexuals with a great sense of communality. Partners change freely, without much jealousy or resentment. Rape is rare. Sometimes the gender and sex roles are comically bent. One day, shortly after I landed in a new facility, I passed by a cell in which a prisoner was wearing a bra. The most puzzling part of this discovery was that he appeared to be pregnant. On one occasion, my bunkie found me irresistible. He’d been serving time for repeated petty theft, not sexual aberrancy, but he had a reputation of being a sexual predator. Fortunately, the CO was doing multiple daily inspections of our cell, so I stashed a razor blade under my bunkie’s mattress and he was transferred to another area of the prison. Getting Out Toward the end of my stay in the state institution, I received a parole date. This date supposedly was fixed, but the warden’s panel pushed it back upon reviewing the citations I had received. I was released on Sept. 9, 2010. The process begins at about 6:30 a.m., with a parade through the medical unit to receive one month’s supply of whatever medications the parolee is taking. After an hour or so comes dress out— the parolee is given a set of brown scrubs and $15 for immediate expenses. Then a ride to the bus station and a ticket to the parole terminus. Once at the parole terminus comes the problem of finding the parole agent’s office. In my case, a Good Samaritan gave me a ride and my parole agent drove me to my parole group home.

I was given a parole loan of $400 to cover my share of the rent—in the form of a check made out to my landlord. Parolees receive no additional funds for food, no identification cards, no money to obtain those cards. The next day, I applied for food stamps and a week or so later I applied for Social Security retirement benefits, which provide me a few dollars per month. Not that I have much opportunity to spend money on anyone besides myself. I have, at least for the moment, no family left. My eldest son sent me a “Daddy dearest” letter many years ago while I was still in Venezuela and I have had no contact with him since. My other son moved out of Michigan, but I plan to contact him in 2012 when my parole is over and I can obtain a credit card and travel. The chances of his rejecting me are high, but it is something I must try. Although I am on parole and able to work, I am still on the outside of medicine trying to get back in. I would like to take a residency program to improve my clinical skills and eventually to regain my license. The federal government never put me on the exclusion list for the Department of Health and Human Services Office of Inspector General, but my state did the equivalent. I spent a significant amount of my time in prison resenting the systems that put me there. Ironically, since getting out I have begun to reflect more on the reasons for my incarceration and my future—whatever it may hold—in medicine. I understand that the judgment of the state in my case was neither unwarranted nor unexpected. However, I also believe that despite my crimes, legitimate questions exist: Should the ire of the government terminate a person’s professional identity? Should those who have served their sentences receive an opportunity to re-enter their profession? Is the practice of medicine unable to re-admit its disgraced? Is the medical concept of rehabilitation reserved for nonphysicians? Ultimately, the answers to those questions aren’t as important as the practical barriers to re-entering the profession. You can’t enter a residency program without a license and you can’t reinstate a license without a comprehensive review of medicine. The legal expenses are dauntingly high—in my state a minimum of $7,500 with no guarantees. Then there’s the cost of obtaining continuing medical education credits, at hundreds and possibly thousands of dollars more. I am trying to splice a living together in any way possible: teaching, driving, physician recruitment for an independent outpatient center, other odd jobs. Ideally, I’ll find someone looking for a

“warm body with a license.” I’m 62 now, and want to be able to go home after an eight-hour workday without aggravation or confrontation. Is even this modest goal too ambitious? Perhaps. I have contacted several residency programs. None has shown any interest in me. The chances that I will get my license back in my state are remote. It does not seem particularly forgiving. I might have better luck somewhere else, however, so moving is an option. I suppose readers of this series assume that the last 30 years of my life were the worst imaginable. But although times certainly got bad, I have come to appreciate certain positive aspects of my experiences. My world was very constricted when I was younger. I grew up in a neighborhood with little ethnic diversity. People bore a sameness—their preconceptions, their taboos, their outlook on life were all predictable. Although long overdue, my ordeal proved to be a powerful reality shift. In rehab and in prison, I met people whom I never would have encountered otherwise—and whom I would have looked down on in other circumstances but now

found many of them to be my superiors in several respects. I observed people whose view of life was what mine had been—and was revolted. I met people who had neither education nor advantages—and came to admire their inner strength. I have become measurably stronger as a human being. I now have the ability to swim in the same water as the rest of humanity. I do not require a safety net and conduct myself in that manner. I can accept that the road back to my chosen profession will be arduous, and there’s no guarantee of success. But I am prepared for that possibility. I can take the necessary steps to re-integrate myself into society without knowing what niche I will occupy. As for my present situation, I can’t help but think of Thoreau’s line: “In the long run, men only hit what they aim at.” My current situation is the product of my own design, conscious or unconscious. If you think that personal drug use and medicine mix in any way, count yourself as one of my colleagues. There are many other ways to change your profession and identity, none of them as traumatic and total as addiction.

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34 I AnesthesiologyNews.com

FEBRUARY 2011

P OLI C Y & M A NAGEMENT

Look Good in Orange? Billing Expert Offers Tips for Avoiding Fraud Charges San Diego—Few anesthesiologists ever seriously consider the possibility of becoming formally acquainted with the Office of Inspector General or the FBI. Yet according to Stanley W. Stead, MD, MBA, chief executive officer of the Los Angeles-based Stead Health Group, Inc., the line that separates legal from illegal billing practices sometimes can be a fine one, and one that every anesthesiologist has a responsibility to understand. In a presentation at the 2010 annual meeting of the American Society of Anesthesiologists (ASA), Dr. Stead discussed the latest developments in billing requirements, and the consequences that often arise when physicians stray beyond these bounds. “Most physicians don’t understand what happens when you submit a bill, what laws apply, what penalties can be incurred,” said Dr. Stead, who chairs the ASA Committee on Economics. “A lot of people don’t think the orange suit is possible for them. But let me assure you, it very much is.” Federal and state governments are more interested than ever in catching Advertisement

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fraud. Officials often rely on whistleblowers to expose such activity. The Department of Health and Human Services Office of Inspector General has found that the majority of such qui tam investigations are triggered by phone calls from disgruntled or former employees who take issue with the practice’s billing patterns. Recovery audit contractors now use computer programs to systematically evaluate billing patterns. “Be aware that this is a situation where you’re very vulnerable, and you have to be absolutely faithful in the way you document and code,” Dr. Stead said. Know the Code Of the many ways that anesthesiologists can run afoul of current legislation, coding issues are the most common, Dr. Stead said. “Creative coding” occurs when a billing code does not exist for a certain procedure, and the practitioner chooses a similar code or one with comparable value. “Unbundling” is the term for when an anesthesiologist deconstructs a complex procedure (for which there is one code) and bills each part separately under different, individual codes. “Upcoding,” on the other hand, occurs when practitioners exaggerate their level of involvement. “A good example is patient visits, when you say you did an E&M level 5 visit and you actually did a level 2,” Dr. Stead explained. Anesthesiologists also must strive to avoid using improper modifiers. Mistakes frequently occur when physicians do not understand the meaning of certain modifiers, yet include them in their billing anyway. “If you don’t understand what a modifier is, you actually have to sit down and read about it in the CPT [Current Procedural Terminology] book,” Dr. Stead said. Although unintentional documentation issues can strike the most well-intentioned practice, medically unbelievable edits are more considered. These typically involve multiple procedures provided on the same day. “Combinations of procedures are also problematic,” he continued. “Frankly, it’s difficult to believe a person would have a mastectomy and an orchiectomy on the same day. But people have tried to bill for this.” Evaluation and management coding is another troublesome area for

‘We can decry that none of us went to medical school to learn how to bill, but the fraud committed by the very few has forced this onerous requirement on all of us. We cannot ignore it.’ —Stanley W. Stead, MD

anesthesiologists. “People are also getting into trouble right now over the use of templates in electronic medical records [EMRs],” Dr. Stead noted. “If you have comprehensive templates and you think you can justify a level 4 or 5 visit simply because you have a template in your EMR, chances are that money is going to have to be returned, plus a fine.” Improper claims by nurse practitioners (NPs) and physician assistants (PAs)—who require their own distinct identification numbers—also can lead to investigation. All claims for services rendered to Medicare beneficiaries must be filed by the employer on behalf of the NP or PA. “You can never have your NP or PA bill in your name when you’re not physically in the office,” Dr. Stead explained.

from a super bill and not looking at your patient medical record, you are facing the possibility of grave consequences if they are inconsistent.” Get a new CPT book every year and review it; codes change. Know the rules and follow them. Each payer is different. The physician, not the billing staff, ultimately is held accountable. “And if all else fails,” he added, “get good legal counsel.” Douglas G. Merrill, MD, director of perioperative services at DartmouthHitchcock Medical Center in Lebanon, N.H., said that physicians who do not take the time to learn billing rules are putting themselves at risk. “As far as the government is concerned, if you bill for medical care, you are expected to understand and follow the rules of billing for medical care,” Dr. Merrill said. “We can decry that Use Protection none of us went to medical school to So what does an anesthesiologist learn how to bill, but the fraud comneed to do to help avoid these pitfalls? mitted by the very few has forced this “Get good billing staff, and remember onerous requirement on all of us. We that they need the best documenta- cannot ignore it.” tion you can provide them,” Dr. Stead —Michael Vlessides advised. “Billing slips and super bills are a poor substitute for good medical records. If your billing staff is billing

Dr. Kain’s Anesthesia Billing Rules To Live By 1. Make sure your billing unit personnel is to up to date with all the most recent compliance information—no short cuts.

4. Make sure your billing practice is being audited once a year by an outside entity—it’s expensive, but worth it.

2. Appoint a quality and compliance officer—one who will take this stuff seriously.

5. Develop an audit system for all your anesthesia records before submitting them to the thirdparty payers—anesthesia information management systems to the rescue.

3. Conduct regular educational sessions in billing and compliance for all clinical staff—mandatory attendance.

6. Don’t be greedy—in work or in life.

Zeev Kain, MD, MBA, is chair of anesthesiology at the University of California, Irvine, School of Medicine, and a member of the editorial board of Anesthesiology News.


AnesthesiologyNews.com I 35

PO LICY & MA NA GEMENT

Hospital Basins Reservoirs For Harmful Bacteria Expert: Consider the equipment in nosocomial outbreaks

P

atients bathing themselves in hospital basins may be increasing their risk for dangerous infection with multidrug-resistant organisms. In a study that involved hundreds of basins in hospitals across the United States and Canada, researchers from Michigan found that the majority of “clean” hospital bath basins were in fact contaminated with harmful bacteria. In the study, infection control specialists cultured 576 randomly chosen basins that appeared to be clean—meaning no visible soiling—in 53 hospitals. The researchers found that 63% of the samples in the multicenter study were contaminated with multidrug-resistant organisms, including vancomycinresistant enterococci (VRE), gramnegative bacilli (GNB) and methicillin-resistant Staphylococcus aureus (MRSA). There were 251 basins from 47 hospitals colonized with GNB, 199 basins from 52 hospitals with VRE and 24 basins from 19 hospitals with MRSA.

‘Hospital basins are another type of medical equipment that is routinely in patient rooms and often forgotten about.’ —Keith Kaye, MD Keith Kaye, MD, professor of medicine at Wayne State University and Detroit Medical Center, and a senior co-investigator on the study, said that the high contamination rate of basins was critical to consider in outbreak settings. “Hospital basins are another type of medical equipment that is routinely in patient rooms and often forgotten about,” Dr. Kaye said. Basins must be dedicated to a single patient and then properly disposed. Dr. Kaye said his group plans to follow up their study by culturing basins in various stages

of use, and more specifically, defining and evaluating the organisms. The findings, presented in January at the 2011 annual meeting of the Society of Critical Care Medicine (abstract 27), broaden the ever-widening scope of what patients and hospital practitioners must consider as they combat the problem of hospital-acquired infections. Hospital professionals have long focused on hand washing to minimize transmission, and in recent years similar studies have found multidrug-resistant organisms on a variety of fixtures in nosocomial settings, including sinks, door handles and computer keyboards in operating rooms. One recent study even turned up traces of germs in physicians’ white coats. Nosocomial infections are a leading cause of mortality in U.S. hospitals, blamed for approximately 100,000 deaths per year. A 2009 report from the Centers for Disease Control and Prevention estimated the annual direct cost of treating health care–acquired infections at $28 billion to $33 billion. The same report said effective infection control interventions could save $6 billion to $20 billion, and prevent as much as 70% of infections. Sharon Jacobs, RN, a spokeswoman for the Association for Professionals in Infection Control and Epidemiology, said the findings support previous research demonstrating the problem of contamination in the hospital setting. Ms. Jacobs, manager of infection prevention and control at St. Clair Hospital, in Pittsburgh, said many hospitals are moving toward using prepackaged bathing systems that are for one-time use. In hospitals that continue to use bath basins, patients, knowingly or not, face the dilemma: “Am I cleaning myself or recontaminating myself ?” The issue of “my bacteria, my wash basin,” is further exacerbated by limited bedside space, which means that personal items like toothbrushes get thrown in these basins. “If people are going to continue to use bath basins they want to be sure they are disinfecting them first, but in reality it’s not going to happen.” —Jennifer Hanawald

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36 I AnesthesiologyNews.com

FEBRUARY 2011

P A IN M E D I C I NE

Smoking Is Painful Subject for Surgical Patients

Specialty

Ever Sued (%)

Sued 2+ Times (%)

Sued in Last 12 Months (%)

Number of Claims Per 100 Physicians

AN by the Numbers: Medical Liability Claim Frequency by Physician Specialty, 2007-2008

General & family practice

38.9

22.2

3.1

80

General internal medicine

34.0

12.5

4.4

58

Internal medicine subspecialties

40.2

21.3

3.6

86

General surgery

69.2

52.0

14.3

213

Surgical subspecialties

57.0

36.5

9.1

170

Pediatrics

27.3

5.4

0.0

36

Obstetrics/gynecology

69.2

52.1

9.5

215

Radiology

47.4

29.0

10.5

116

Psychiatry

22.2

8.1

2.0

39

Anesthesiology

42.4

14.8

2.3

67

Pathology

34.9

9.5

3.4

55

Emergency medicine

49.8

30.9

8.7

109

Other specialties

35.0

15.8

3.5

66

Source: American Medical Association, 2010

1.8

Odds Ratio

Francisco, who led the study. Recognizing the risk factors for postoperative pain ultimately will allow physicians to identify and treat patients who are particularly prone to discomfort. Although previous research suggested that smokers experience more postoperative pain and complications (Figure) than do nonsmokers, those studies were limited by small sample sizes, Dr. Apfel said. So he and colleagues from 12 hospitals prospectively collected preoperative, intraopera‘I use the preoperative tive and postoperative data on 2,157 period as a teaching adults having elective ambulatory surgery under general anesthesia. Severe moment, and explain acute postoperative pain was defined as a score of 7 or higher on a 10-point that volatile anesthetic verbal rating scale. Pain was assessed at drugs are potent inhibitors numerous time points after cessation of anesthesia, until 48 hours after hospital discharge. of nicotine receptors.’ As Dr. Apfel reported at the 2010 annual meeting of the American Soci—Pamela Flood, MD ety of Anesthesiologists (abstract A788), 24.5% of all patients experiMore than 15 million Americans suf- enced severe postoperative pain while fer from severe postoperative pain every in the postanesthesia care unit (PACU). year, said Christian C. Apfel, PhD, By 48 hours after discharge, this numMD, associate professor of anesthesiol- ber had risen to 33.6%. At all time points, smokers were ogy at the University of California, San San Diego—Add severe acute postoperative pain to the ever-growing list of negative effects related to smoking. A multicenter study of more than 2,000 patients who underwent ambulatory surgery has found that two days after discharge, more than half of smokers report severe postoperative pain compared with fewer than onethird of nonsmokers.

1.6 1.4 1.2

1.1

1-10

11-22

23-40

40+

Smoking Amount (pack-years) Figure. Odds ratio for major complications (smoking amount categories vs. never-smoker). Source: 2010 annual meeting of the American Society of Anesthesiologists, abstract A1189.

more likely than nonsmokers to report severe pain. In the PACU, severe pain was present in 38.5% of smokers and 22% of nonsmokers. By 48 hours after discharge, 54.1% of smokers and 29.9% of nonsmokers called their pain severe. Pain intensity in the PACU also was greater in smokers than in nonsmokers (score, 4.94 vs. 3.74, respectively; P<0.001), and again at 48 hours after discharge (6.35 vs. 4.60, respectively; P<0.001). “It was also important for us to determine the relevant risk factors for severe post-discharge pain,” Dr. Apfel said. Logistic regression analysis identified current smoking status as a significant independent predictor of pain (P=0.001). Smoking was associated with a higher risk for severe postoperative pain in the PACU (odds ratio [OR], 1.74) and at 48 hours after discharge (OR, 2.25; P>0.001). Other significant independent predictors for severe pain in the PACU included age 50 years or older (OR, 1.53), a body mass index greater than 30 (OR, 1.36) and surgery times longer than one hour (OR, 1.36). Patients who before surgery anticipated experiencing a postoperative pain score of 4 or higher also were at increased risk for severe pain in the PACU (OR, 1.45). Given these results, the investigators recommended that physicians include patient’s smoking status during preoperative evaluations. “We want to develop a predictive model to see if we can get a better idea of who will be at risk for severe postoperative pain, and whether this predicts the development

of chronic postoperative pain,” Dr. Apfel said. Pamela D. Flood, MD, associate professor of clinical anesthesiology at Columbia University Medical Center, in New York City, said the study has important clinical implications. “If smoking is a strong predictor of severe postoperative pain, is this a mediator for the heightened risk of smokers to develop chronic pain syndromes?” Dr. Flood asked. “If smokers are specifically targeted for enhanced pain management and/or smoking cessation, this intervention may ameliorate acute postoperative pain or the conversion to chronic pain.” Most doctors consider smoking history as an important part of medical history, particularly with regard to cardiac and respiratory risks. Pain should be added to that list. “I use the preoperative period as a teaching moment, and explain that volatile anesthetic drugs are potent inhibitors of nicotine receptors [Toxicol Lett 1998;100-101:149-153],” Dr. Flood said. “There is evidence that a patient is essentially detoxified from smoking after general anesthesia and has reduced cravings for nicotine after surgery and anesthesia [Anesthesiology 2006;104:356-367; Anesthesiolog y 2010;113:977-992],” she added. “If they want to stop—and most people do—this would be a good time.” The poster was selected as one of the best presented at the meeting. —Michael Vlessides


FEBRUARY 2011

AnesthesiologyNews.com I 37

PA IN M E D ICIN E

Mild Analgesics During Pregnancy May Increase Risk For Reproductive Disorders in Male Offspring

W

omen who take mild analgesics during pregnancy may be at increased risk for giving birth to infants with congenital cryptorchidism, according to a prospective study from Scandinavia. However, the findings were mixed, with the link appearing in women from Denmark but not those from Finlandâ&#x20AC;&#x201D;a split the researchers could not fully explain. Recent evidence suggests that mild analgesics, such as acetaminophen, aspirin or ibuprofen, can disrupt endocrine activity in animals (Environ Health Perspect 2010 Nov. 16 [Epub ahead of print]). At the same time, several

reports have indicated an increase in the incidence of male reproductive disorders over recent decades, and in both Europe and the United States, more than 50% of pregnant women report taking mild analgesics. To clarify the effect that mild analgesics may have on humans, lead study investigator Henrik Leffers, MD, PhD, senior scientist at the Rigshospitalet in Copenhagen, and colleagues prospectively analyzed the rates of congenital reproductive defects in male infants. In the study, 2,297 Danish and Finnish pregnant women completed a questionnaire and 491 Danish mothers participated in a telephone interview, providing information on their use of mild analgesics during pregnancy (Hum Reprod 2010 Nov 8 [Epub ahead of print]). Pediatricians assessed testicular position in newborns. The authors also examined the impact of mild analgesics on anogenital distance in male rats. The researchers found that the use of mild analgesics during pregnancy was associated with congenital cryptorchidism, in a dose-response fashion, in the Danish cohort. Danish women who used acetaminophen, ibuprofen or aspirin in the second trimester were 2.3 times more likely than those who did not use an analgesic to give birth to an infant with cryptorchidism or undescended testes (P=0.032). Danish women who used more than one of the analgesics at any time during pregnancy were more than seven times as likely to have a child with cryptorchidism as those who did not use any analgesics (odds ratio, 7.55; P=0.007). Furthermore, Danish women who used an analgesic for more than two

weeks during their pregnancy were 2.5 times more likely to give birth to infants with cryptorchidism, with the likelihood increasing to 21.7 if women used multiple analgesics for at least two weeks (P<0.045 for both). Multivariate analyses confirmed that the correlations between analgesic use and

cryptorchidism persisted after controlling for other known risk factors for male reproductive disorders. The rat model supported the data in Danish women, revealing that fetal exposure to mild analgesics exerted an anti-androgenic action in the male rat. Specifically, ratsâ&#x20AC;&#x2122; intrauterine exposure

to paracetamol led to a reduction in anogenital distance, and mild analgesics reduced testosterone production in ex vivo fetal rat testes. In contrast, the investigators did not find an association between analgesic use during pregnancy and reproductive see analgesics page 43


38 I AnesthesiologyNews.com

FEBRUARY 2011

P A IN M E D I C I NE

Botox-A Shown Ineffective for Treating Myofascial Pain

A

Pain Medicine, in Phoenix (abstract 111), showed that the eight patients who received the injections (BotoxA, Allergan) in three trigger points experienced reductions in pain for only eight weeks. These results are in line with prior research, the bulk of which “do not support the use of Botox-A trigger point injections for myofascial pain,”

randomized controlled trial exploring the effectiveness of botulinum toxin A to treat cervical myofascial pain syndrome showed that the drug did not perform well long-term in this patient population. The study, presented at the 2010 annual fall meeting of the American Society of Regional Anesthesia and

Qutenza® (capsaicin) 8% patch

Other Adverse Reactions Observed During the Clinical Studies of Qutenza: General Disorders and Administration-Site Conditions: application-site urticaria, application-site paresthesia, application-site dermatitis, application-site hyperesthesia, application-site excoriation, application-site warmth, application-site anesthesia, application-site bruising, application-site inflammation, application-site exfoliation, peripheral edema Nervous System Disorders: headache, burning sensation, peripheral sensory neuropathy, dizziness, dysgeusia, hyperesthesia, hypoesthesia Respiratory, Thoracic, and Mediastinal Disorders: cough, throat irritation Skin and Subcutaneous Tissue Disorders: abnormal skin odor

Rx Only

BRIEF SUMMARY OF PRESCRIBING INFORMATION (For complete prescribing information please see package insert.) DESCRIPTION Qutenza (capsaicin) 8% patch contains capsaicin in a localized dermal delivery system. The capsaicin in Qutenza is a synthetic equivalent of the naturally occurring compound found in chili peppers. INDICATIONS AND USAGE Qutenza is indicated for the management of neuropathic pain associated with postherpetic neuralgia. WARNINGS AND PRECAUTIONS Eye and Mucous Membrane Exposure: Do not apply Qutenza to the face or scalp to avoid risk of exposure to the eyes or mucous membranes. Aerosolization of Capsaicin: Aerosolization of capsaicin can occur upon rapid removal of Qutenza patches. Therefore, remove Qutenza patches gently and slowly by rolling the adhesive side inward. If irritation of eyes or airways occurs, remove the affected individual from the vicinity of Qutenza. Flush eyes and mucous membranes with cool water. Inhalation of airborne capsaicin can result in coughing or sneezing. Provide supportive medical care if shortness of breath develops. Unintended Skin Exposure: If skin not intended to be treated comes in contact with Qutenza, apply Cleansing Gel for one minute and wipe off with dry gauze. After the Cleansing Gel has been wiped off, wash the area with soap and water. Application-Associated Pain: Even following use of a local anesthetic prior to administration of Qutenza, patients may experience substantial procedural pain. Prepare to treat acute pain during and following the application procedure with local cooling (such as an ice pack) and/or appropriate analgesic medication, such as opioids. Opioids may affect the ability to perform potentially hazardous activities such as driving or operating machinery. Increase in Blood Pressure: In clinical trials, increases in blood pressure occurred during or shortly after exposure to Qutenza. The changes averaged less than 10 mm Hg, although some patients had greater increases and these changes lasted for approximately two hours after patch removal. Increases in blood pressure were unrelated to the pretreatment blood pressure but were related to treatment-related increases in pain. Monitor blood pressure during the treatment and provide adequate support for treatment-related pain. Patients with unstable or poorly controlled hypertension, a recent history of cardiovascular or cerebrovascular events may be at an increased risk of adverse cardiovascular effects. Consider these factors prior to initiating Qutenza treatment. ADVERSE REACTIONS The following serious adverse reactions are discussed in Warnings and Precautions: ApplicationAssociated Pain and Increase in Blood Pressure. Clinical Trials Experience: Across all controlled and uncontrolled trials, more than 1,600 patients have received Qutenza. A total of 394 patients received more than one tre atment application and 274 patients were followed for 48 weeks or longer. In controlled clinical studies, 98% of patients completed ≥ 90% of the intended patch application duration. Among patients treated with Qutenza, 1% discontinued prematurely due to an adverse event. Controlled Clinical Studies: Common Adverse Reactions: adverse reactions occurring in ≥ 5% of patients in the Qutenza group and at an incidence greater than in the control group were application-site erythema, application-site pain, application-site pruritus and application-site papules. Table 1 summarizes all adverse reactions, regardless of causality, occurring in ≥ 1% of patients with postherpetic neuralgia in the Qutenza group for which the incidence was greater than in the control group. The majority of application-site reactions were transient and self-limited. Transient increases in pain were commonly observed on the day of treatment in patients treated with Qutenza. Pain increases occurring during patch application usually began to resolve after patch removal. On average, pain scores returned to baseline by the end of the treatment day and then remained at or below baseline levels. A majority of Qutenza-treated patients in clinical studies had adverse reactions with a maximum intensity of “mild” or “moderate.” TABLE 1: Treatment-emergent adverse reaction incidence (%) in controlled trials in postherpetic neuralgia (events in ≥ 1% of Qutenza-treated patients and at least 1% greater in the Qutenza group than in the control group) Body System Preferred Term

DRUG INTERACTIONS No clinical drug interaction studies have been performed. Data from in vitro cytochrome P450 inhibition and induction studies show that capsaicin does not inhibit or induce liver cytochrome P450 enzymes at concentrations which far exceed those measured in blood samples. Therefore, interactions with systemic medicinal products are unlikely. USE IN SPECIFIC POPULATIONS Pregnancy - Category B There are no adequate and well-controlled studies evaluating Qutenza in pregnant women. There was no evidence of fetal teratogenicity in embryofetal developmental toxicological studies conducted in pregnant rats and rabbits in which Qutenza patches (rats) or liquid (rabbits) were applied once daily for a 3-hour duration during the period of fetal organogenesis up to doses corresponding to an 11-fold margin over the maximum recommended human dose [MRHD] based on a Cmax exposure comparison. A peri- and post-natal reproduction toxicology study in rats showed no effects on survival, growth, learning and memory tests, sexual maturation, mating, pregnancy, and fetal development in the offspring of mothers treated with capsaicin up to an 11-fold margin over the MRHD. Labor and Delivery: The effects of Qutenza on labor and delivery are unknown. Nursing Mothers: There are no adequate and well-controlled studies in nursing women. Studies in rats have demonstrated capsaicin is excreted into breast milk of this species. It is unknown whether capsaicin is excreted in human breast milk. Because Qutenza is administered as a single 60-minute application and capsaicin is rapidly cleared from the bloodstream, mothers can reduce infant exposure by not breast-feeding after treatment on the day of treatment. Pediatric Use: The safety and effectiveness of Qutenza in patients younger than 18 years of age have not been studied. Geriatric Use: In controlled clinical studies of Qutenza in neuropathic pain associated with postherpetic neuralgia, 75% of patients were 65 years and older and 43% of patients were 75 years and older. Safety and effectiveness were similar in geriatric patients and younger patients. No dose adjustments are required in geriatric patients. OVERDOSAGE There is no clinical experience with Qutenza overdose in humans. There is no specific antidote for overdose with capsaicin. In case of suspected overdose, remove patches gently, apply Cleansing Gel for one minute, wipe off with dry gauze and gently wash the area with soap and water. Use supportive measures and treat symptoms as clinically warranted. NONCLINICAL TOXICOLOGY Carcinogenesis, Mutagenesis, Impairment of Fertility: Adequate carcinogenicity studies have not been conducted with Qutenza or capsaicin. Capsaicin was not mutagenic in the Ames, mouse micronucleus and chromosomal aberration in human peripheral blood lymphocytes assays. As with other catechol-containing compounds (eg, dopamine), capsaicin showed a weak mutagenic response in the mouse lymphoma assay. A fertility and reproductive toxicology study was conducted in rats with exposure to Qutenza patches daily for 3 hours/day beginning 28 days before cohabitation, through cohabitation and continuing through the day before sacrifice (approximately 49 days of treatment). The results revealed a statistically significant reduction in the number and percent of motile sperm. Sperm motility obtained from the vas deferens was reduced in all capsaicin treatment groups (16, 24, and 32 mg capsaicin patch/rat/day). Though a “no effect” level was not determined, dose levels used in the study correspond to a 13- to 28-fold exposure margin over the mean Cmax associated with the maximal human recommended dose. Sperm counts were reduced in the vas deferens or cauda epididymis in the 24 and 32 mg capsaicin patch/rat/day dose groups (79 and 69%, respectively) compared to the placebo-patch-treated control group; however, these reductions did not adversely affect fertility. As this animal model has a large excess of sperm-generating capacity relative to the threshold necessary for fertilization, the lack of an effect on fertility in this species is of unknown significance for human risk assessment. DOSAGE AND ADMINISTRATION Special precautions: • Only physicians or health care professionals under the close supervision of a physician are to administer Qutenza. • Use only nitrile gloves when handling Qutenza, and when cleaning capsaicin residue from the skin. • Immediately after use, dispose of used and unused patches, cleansing gel, and other treatment materials in accordance with the local biomedical waste procedures. • Use Qutenza only on dry, intact (unbroken) skin. Dosing: The recommended dose of Qutenza is a single, 60-minute application of up to four patches. Treatment with Qutenza may be repeated every three months or as warranted by the return of pain (not more frequently than every three months).

Qutenza 60 minutes (N = 622) %

Control 60 minutes (N = 495) %

Application-Site Erythema

63

54

Application-Site Pain

42

21

Application-Site Pruritus

6

4

Application-Site Papules

6

3

Application-Site Edema

4

1

Application-Site Swelling

2

1

Application-Site Dryness

2

1

HANDLING AND DISPOSAL Qutenza contains capsaicin capable of producing severe irritation of eyes, skin, respiratory tract, and mucous membranes. Do not dispense Qutenza to patients for self-administration. It is critical that health care professionals who administer Qutenza have completely familiarized themselves with proper dosing, handling, and disposal procedures before handling Qutenza to avoid accidental or inadvertent capsaicin exposure to themselves or others [see Dosage and Administration]. Do not touch Qutenza, treatment areas, and all used supplies or other materials placed in contact with the treatment area without wearing nitrile gloves. Wear nitrile gloves at all times while handling Qutenza and cleaning treatment areas. Do NOT use latex gloves. Do not hold Qutenza near eyes or mucous membranes. Immediately after use, dispose of used and unused patches, patch clippings, unused Cleansing Gel, and associated treatment supplies in accordance with local biomedical waste procedures. PATIENT COUNSELING INFORMATION See Patient Counseling Information section of the full package insert.

GENERAL DISORDERS AND ADMINISTRATION-SITE CONDITIONS

Infections and Infestations Nasopharyngitis

4

2

Bronchitis

2

1

Sinusitis

3

1

Nausea

5

2

Vomiting

3

1

2

<1

2

1

Gastrointestinal Disorders

Skin and Subcutaneous Tissue Disorder Pruritus Vascular Disorders Hypertension

Manufactured for NeurogesX, Inc., San Mateo, CA 94404, USA by Lohmann Therapie-Systeme AG (LTS), Andernach, Germany www.Qutenza.com Qutenza® is a registered trademark of NeurogesX, Inc. © NeurogesX, Inc. 2010 Rev. November 2009 109270-1

‘Although Botox-A was superior to saline in reducing cervical myofascial pain, the average degree and durability of the pain relief was not sufficient to recommend using it as a first-line treatment for the condition.’ —Jarred Younger, PhD

said Jarred Younger, PhD, assistant professor in pain management in the Department of Anesthesia at Stanford University School of Medicine, in California. However, Dr. Younger noted that the study’s small sample size limits the generalizability of the findings. Previous trials examining the efficacy of Botox-A for treating myofascial pain have yielded mixed results, and the treatment has not found a place in many physicians’ portfolio of therapies for the condition (e.g., Pain 2001;94:255-260). In the current study, lead investigator Pankaj Satija, MD, a fellow in the Department of Anesthesiology at the University of Texas Health Science Center at San Antonio, and three colleagues randomized eight patients with chronic myofascial pain to receive three injections of up see myofascial page 43


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Lesson 290: PreAnesthetic Assessment of the Pregnant Patient With Mitral Stenosis WRITTEN BY:

LEARNING OBJECTIVES

Michael Mazzeffi, MD, MPH Chief resident in anesthesiology, Mount Sinai Medical Center, New York, New York

At the end of this activity, the participant should be able to: 1. Explain why mitral stenosis is commonly diagnosed for the first time during pregnancy. 2. Recognize the echocardiographic findings used to classify the severity of mitral stenosis. 3. Describe the normal physiologic changes in the cardiovascular system during pregnancy. 4. Assess the indications, risks, and scoring systems that predict the success of percutaneous balloon mitral valvuloplasty. 5. Summarize the risks and feasibility of cardiopulmonary bypass for the pregnant patient and the fetus. 6. List hemodynamic goals for a patient with mitral stenosis. 7. Compare the risks and benefits of regional analgesia and anesthesia versus general anesthesia in patients with severe mitral stenosis. 8. Select appropriate hemodynamic monitors for the anesthetic management of a patient with severe mitral stenosis. 9. Identify the particular risks that surgery and delivery of the fetus pose to the patient with severe mitral stenosis. 10. Describe the management of the decompensating patient with severe mitral stenosis.

REVIEWED BY: Ronald Kahn, MD Professor of anesthesiology and surgery, Mount Sinai School of Medicine, New York, New York

DATE REVIEWED: January 2011 TARGET AUDIENCE Anesthesiologists

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

DISCLOSURES The author, reviewer, and editor have no relationships with pharmaceutical companies or manufacturers of products to disclose. This educational activity may contain discussion of published and/or investigational uses of agents for the treatment of disease. Some uses of these agents have not been approved by the FDA. Please refer to the official prescribing information for each product for approved indications, contraindications, and warnings.

NEEDS STATEMENT Mitral stenosis often is first diagnosed during pregnancy when normal physiologic changes exacerbate symptoms of the disease. To manage the obstetric patient with mitral stenosis, a multidisciplinary approach is crucial for ensuring an optimal outcome. A cardiologist, high-risk obstetrician, cardiothoracic surgeon, and anesthesiologist should be involved

D

uring pregnancy, certain cardiovascular changes are predictable, including an increase in blood volume and heart rate, a decrease in systemic vascular resistance, and increased cardiac output. Left ventricular function is normal and ejection fraction is not significantly altered. These changes are thought to be adaptive in that they improve placental perfusion and also prepare the mother for blood loss at the time of delivery. However, such modifications are not always beneficial—especially in patients with underlying cardiac valvular stenosis—and can be particularly harmful in patients with mitral stenosis because a narrowed mitral valve orifice allows a relatively fixed amount of blood to move across during diastole. Thus, when cardiac output and blood volume increase during pregnancy and the mitral valve is stenotic, left atrial pressure is markedly increased. Additionally, increased cardiac output increases the transmitral pressure gradient, which worsens symptoms of congestive heart failure and eventually leads to pulmonary edema and respiratory distress. If left atrial pressure becomes severely elevated, pulmonary

PREANESTHETIC ASSESSMENT Dr. Elizabeth A.M. Frost, who is the editor of this continuing medical education series, is clinical professor of anesthesiology at the Mount Sinai School of Medicine in New York City. She is the author of Clinical Anesthesia in Neurosurgery (ButterworthHeinemann, 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 February 29, 2012. (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: February 2011 TERMINATION DATE: February 29, 2012 ACCREDITATION STATEMENT The Mount Sinai School of Medicine is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

as early as possible in the patient’s care and delivery plan. Anesthesiologists also should be aware of the hemodynamic goals for mitral stenosis and how to manage the decompensating patient. This topic has been identified by committee as important information for anesthesiologists.

CASE HISTORY A 32-year-old woman was diagnosed with moderate to severe mitral stenosis in week 29 of pregnancy. The presence of placenta previa was noted; there also was a concern for placenta accreta. Sixteen years previously, the patient had undergone a cesarean delivery (outside the United States) that was occasioned by fetal distress. A healthy fetus was delivered and there were no complications of labor reported at that time. The woman reported having poor exercise tolerance (class 2, New York Heart Association [NYHA] functional classification of heart disease) prior to her current pregnancy, but had no other symptoms. She underwent transthoracic echocardiography at 29 weeks of gestation. The findings included a mitral valve pressure half-time of 169 milliseconds (corresponding to an estimated mitral valve area [MVA] of 1.3 cm2), a mean gradient of 17 mm Hg, and a Wilkins mitral valvuloplasty score of 7. Moderatesevere mitral valve regurgitation with an eccentric jet also was observed. Fractional area change in the left ventricle was estimated to be 60%. The patient had mild pulmonary hypertension with systolic pulmonary artery pressure estimated at 36 mm Hg. Moderate tricuspid regurgitation also was noted.

hypertension and right ventricular heart failure may occur. The pathology is further worsened by tachycardia, which shortens the duration of left ventricular filling.

Echocardiographic Examination for Mitral Stenosis Normally the area of the mitral valve is between 4 and 6 cm2.1 When the area is reduced to less than 2 cm2, the transvalvular pressure gradient is increased. Continuous wave Doppler ultrasound should be used to measure the velocity of blood flow across the mitral valve. (The use of pulse wave Doppler may result in “aliasing” at high-velocity blood flow. Aliasing occurs when the frequency sampled is greater than one-half the pulse repetition frequency delivered from the echo probe. This can lead to an inaccurate estimation of blood flow velocity.) After measuring the velocity, the transvalvular pressure gradient can be estimated by using the modified Bernoulli equation (Figure 1). Mean gradient is the clinically relevant measurement

CREDIT DESIGNATION STATEMENT The Mount Sinai School of Medicine designates this educational activity for a maximum of 2 AMA PRA Category 1 Credits.™ Physicians should only claim credit commensurate with the extent of their participation in the activity. It is the policy of Mount Sinai School of Medicine to ensure objectivity, balance, independence, 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.

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CONTINUING MEDICAL EDUCATION

This lesson is available online at www.mssm.procampus.net

Table 1. Echocardiographic Evaluation of Mitral Stenosis Stenosis

Mean Pressure Gradient, MVA, cm2 mm Hg

Mild

>1.5

<5

Moderate 1-1.5

5-10

Severe

>10

<1

MVA, mitral valve area

variables with echocardiographic variables have been developed. One such multifactorial scoring system developed by Cruz-Gonzalez and colleagues showed higher success with PBMV in males, patients classified as NYHA class 1 or 2, and patients less than 55 years old.5 This multifactorial scoring system also showed that patients with high-grade mitral regurgitation were less likely to have an optimal outcome. In the case presented here, the Wilkins score for the patient was 7; however, because of her significant mitral regurgitation, we believed the procedure would not improve her symptoms.

Cardiac Surgery in the Obstetric Patient because it is most precise. Mean gradients in the range of 5 to 10 mm Hg are consistent with moderate mitral stenosis; mean gradients above 10 mm Hg are consistent with severe mitral stenosis (Table 1).2 At least 2 other echocardiographic evaluations are useful in estimating the severity of mitral stenosis. First is the measurement of mitral valve pressure half-time (ie, the time it takes for the transvalvular pressure gradient to decrease to 50% of its maximum value). An MVA may be estimated using the following equation: MVA, cm2=220/pressure half-time, milliseconds. MVAs of 1 to 1.5 cm2 are consistent with moderate mitral stenosis and areas less than 1 cm2 are consistent with severe mitral stenosis. The area of the mitral valve orifice also can be estimated using planimetry. The opening of the mitral valve can be visualized and the area traced to provide an estimation of the MVA. Severe calcification of the mitral valve may interfere with a determination of its area by planimetry, and in patients with significant subvalvular stenosis, the degree of hemodynamic compromise may be underestimated.

Minimally Invasive Valvuloplasty Percutaneous balloon mitral valvuloplasty (PBMV) is a minimally invasive procedure that has been performed in the cardiac catheterization suite since the mid-1980s. The procedure involves left-sided heart catheterization and inflation of a balloon across a stenotic mitral valve to increase the orifice area. Significant mitral regurgitation and left atrial thrombus are contraindications to PBMV. The procedure has a high level of efficacy when patients are selected appropriately. In one case series of 74 patients, valve area increased by at least 50% in 73% of participants.3 Unfortunately, the procedure is not successful in all patients. Serious complications include death, cardiac tamponade, systemic embolism, and worsening mitral regurgitation; emergent surgery also may be necessary. In the previously mentioned case series, the death rate was 3%. A number of scoring systems have been developed to help predict the success of PBMV. The Wilkins score, first described in 1988, is one of the oldest and most widely accepted systems based solely on echocardiographic criteria (Table 2).4 The Wilkins scoring system uses 4 echocardiographic criteria to determine an overall score between 4 and 16: mitral valve mobility, subvalvular thickening, valve thickening, and valve calcification. Using this system, patients with a lower score are more likely to have an optimal outcome, whereas a high score is more likely associated with a suboptimal outcome. In the original study,4 7 was the mean score in the optimal outcome group and 11 was the mean score in the suboptimal outcome group. Recently, other scoring systems that incorporate clinical

Cardiac surgery performed in obstetric patients entails relatively low risk for the mother. However, the risk for fetal mortality has been estimated as high as 33%â&#x20AC;&#x201D;which may be unacceptably high unless surgery is absolutely necessary and there is no alternative.6 Cardiopulmonary bypass (CPB), especially when performed under conditions of maternal hypothermia, can lead to tonic contraction of the uterus and compromise uterine blood flow. The mechanism by which hypothermia leads to tonic contraction of the uterus during CPB is not well described. A prolonged decrease in uterine blood flow leads to fetal acidosis and hypoxemia. Typically, this is displayed on the fetal heart tracing as a late deceleration. When compared with normothermic CPB, hypothermic CPB has been shown to increase the risk for fetal mortality; the lower the temperature the greater the risk to the fetus. At least 2 other factors may account for an increased risk to the fetus during CPB. First, it has been postulated that dilution of maternal progesterone levels in the CPB circuit may increase uterine contractions. Second, animal studies have shown that nonpulsatile blood flow during CPB causes severe placental dysfunction and vasoconstriction leading to fetal acidosis, and even fetal death.7 This effect may be negated by pulsatile CPB, but no human studies corroborate the findings in animal studies. If CPB is performed on a woman carrying a viable fetus, fetal monitoring should be carried out during surgery; however, it can be technically challenging and heart rate abnormalities are common. Fetal bradycardia is the most common response to the initiation of CPB, and a normal heart rate typically returns after resumption of normal circulation.8 The significance of bradycardia and its effects

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P=4 Ă&#x2014; V2 P, pressure gradient, mm Hg; V, blood flow velocity

Figure 1. Modified Bernoulli equation.

on the fetus has not yet been fully elucidated. However, attempts should be made to increase placental perfusion if mean arterial pressure is low. This usually is accomplished through the use of vasopressors or by increasing CPB flow rates. In the case presented here, the cardiac surgeon believed that valve repair was indicated because the patient was classified as NYHA class 4 and there was echocardiographic evidence of severe mitral stenosis and regurgitation. However, after discussing all options, the multidisciplinary team decided that the risks associated with valve repair during pregnancy outweighed the maternal benefit. In addition, the patient was not willing to consent for cardiac surgery with a risk for fetal mortality as high as 33%. Instead, valve repair 3 months after delivery was plannedâ&#x20AC;&#x201D;unless the patient required emergent sternotomy and CPB at the time of delivery.

Hemodynamic Goals in Mitral Stenosis The hemodynamic goals for any patient can be divided into 4 categories: preload, afterload, heart rate, and contractility goals. In a patient with mitral stenosis, the anesthesiologist should aim to maintain a normal preload, high afterload, slow heart rate, and normal contractility. Tachycardia is especially detrimental to the patient with mitral stenosis because it decreases left ventricular diastolic filling time and myocardial perfusion time during diastole. Tachycardia also can increase left atrial pressure, leading to subsequent pulmonary hypertension and pulmonary edema. Myocardial contractility should be kept in the normal range. Excessive increases in myocardial contractility may lead to ischemia by increasing oxygen demand while output from the left ventricle is compromised. Systemic vascular resistance (afterload) should be kept in the higher range because it improves myocardial perfusion pressure. Preload should be kept in the normal range to maintain stroke volume, but the anesthesiologist

Table 2. Wilkins Mitral Valvuloplasty Scorea

a

Score Mobility

Subvalvular Thickening

Thickening

Calcification

1

Highly mobile; only leaflet tip is restricted

Minimal thickening just below valve leaflets

Leaflets near normal in thickness (4-5 mm)

Single area of increased echo brightness

2

Leaflet mid and base have normal mobility

Thickening of chordal structures extending up to one-third of chordal length

Mid-leaflets normal; considerable thickening of margins (5-8 mm)

Scattered areas of brightness confined to leaflet margins

3

Valve continues to Thickening extending to distal move forward in dias- one-third of chords tole, mainly from base

Thickening extending through entire leaflet (5-8 mm)

Brightness extending into mid-portion of leaflets

4

No or minimal forward movement in diastole

Extensive thickening and shortConsiderable thickening Extensive brightness ening of all chordal structures of all leaflet tissue throughout much of extending to the papillary muscles (>8-10 mm) leaflet tissue

Based on echocardiographic criteria alone; predicts the success of intervention.4


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must be cautious because excessively high preload can lead to pulmonary edema and rapid decompensation. Achieving these goals is a challenge, but is possible with the use of appropriate monitors and well-planned anesthesia. In order to maintain preload in the normal range, the anesthesiologist should administer IV crystalloid in a goal-directed manner. Volume status can be accurately assessed using pulse pressure variation on the arterial waveform or transesophageal echocardiography (TEE). High afterload can be achieved and maintained by avoiding the administration of anesthetics that cause significant vasodilation and also by administering vasoconstricting drugs during periods of hypotension. A pure α-1 adrenergic agonist, such as phenylephrine, is an excellent choice for treating hypotension because it increases afterload while decreasing heart rate. To maintain the patient at a slow heart rate, the anesthesiologist must induce a sufficient depth of anesthesia. The short-acting opioid, remifentanil, can be very helpful in achieving this goal because it induces deep anesthesia during surgery, but is rapidly eliminated. The anesthesiologist also should avoid anesthetics that commonly lead to tachycardia, such as ketamine. If tachycardia develops, the β-blocker esmolol is an excellent choice for treatment because of its β-1 selectivity and short duration of action. Finally, anesthetics that significantly decrease myocardial contractility, such as volatile agents in high doses, should be avoided because of their detrimental effects.

Preoperative Assessment and Anesthetic Planning When taking the preoperative history of a patient with mitral stenosis, the anesthesiologist should ask him or her about exercise tolerance and ability to lie comfortably in the supine position. Patients who have low exercise tolerance or difficulty lying supine are likely to have severe disease. The NYHA classification system provides a simple way to classify severity of heart failure and is useful in determining prognosis (Table 3). In general, patients with symptoms classified as 3 or 4 and in whom there is echocardiographic evidence of significant dysfunction of the mitral valve may require optimization or intervention. In any patient with known mitral stenosis, the anesthesiologist must review the echocardiography report preoperatively. In particular, the mean pressure gradient across the mitral valve and the estimated mitral valve area must be considered to estimate the severity of mitral stenosis. Right and left ventricular function and the degree of of pulmonary hypertension should also be considered. The anesthesiologist also should review the chest x-ray for evidence of pulmonary edema and cardiomegaly to help gauge the severity of disease. Obtaining a complete blood count may be helpful in evaluating anemia and the potential need for blood products during surgery. Regional anesthetic techniques are the mainstay of obstetric anesthesia and have an excellent safety record. However, these techniques may not be safe in all patients with mitral stenosis. Regional techniques are associated with hemodynamic changes that are opposite to the previously stated hemodynamic goals in patients with mitral stenosis. Also, patients commonly develop tachycardia when undergoing labor, which can be detrimental. Nevertheless, the evidence indicates that epidural anesthesia can be a safe and effective technique in patients with severe mitral stenosis. In one retrospective study in South Africa, 128 consecutive patients with mitral stenosis were followed.9 In all, 49% of these women had an MVA less than 1.2 cm2. The rate of maternal complications during pregnancy was high (51%). By far, the most common

complication was pulmonary edema. Twenty women in the study underwent PBMV during pregnancy, with good results. The remainder were managed medically until time of delivery. In 60% of the patients, epidural anesthesia was successful and without complications. There were no maternal deaths and fetal outcome was satisfactory in 91% of the cases. Alternatively, spinal anesthesia with local anesthetics is not advisable in patients with severe mitral stenosis. The rapid sympathectomy that occurs with spinal anesthesia with these agents can lead to cardiac arrest if myocardial ischemia develops after a fall in preload and afterload. Additionally, no large case series studies have been published to support the safe use in this group of patients. Spinal anesthetic techniques that are purely opioid based, however, may provide adequate labor analgesia. In fact, placement of an intrathecal catheter and continuous opioid infusion is an excellent method for providing labor analgesia for the patient with severe mitral stenosis, because it does not significantly decrease preload and afterload and tends to maintain a slow heart rate. In the case presented, this technique was not an option because cesarean delivery was indicated and intrathecal opioids alone were unlikely to provide adequate anesthesia. The obvious alternative to regional anesthesia is general anesthesia. Inherent risks and periods of instability associated with general anesthesia include induction, laryngoscopy, and emergence. Tachycardia commonly develops at such times and a severe drop in preload or afterload can occur after induction. Etomidate is the induction agent of choice because it offers the most hemodynamic stability. Remifentanil may be a good choice to blunt the hemodynamic response during laryngoscopy because of its rapid elimination, which leads to minimal residual effect on the fetus. Remifentanil also can be given by infusion during the case to maintain a slow heart rate and adequate depth of anesthesia. One benefit of general anesthesia is that it allows for emergent sternotomy and initiation of CPB in a patient who undergoes acute decompensation. It also allows for the use of TEE, intraoperatively. If possible, a cesarean delivery should be performed in a cardiac operating room (OR) with a cardiac surgery team available.

Selection of Hemodynamic Monitors Appropriate hemodynamic monitors can be very helpful in guiding therapy to achieve hemodynamic goals. Arterial cannulation is advisable in the obstetric patient with severe mitral stenosis, regardless of the anesthetic technique chosen. If general anesthesia is selected, an arterial line should be placed prior to induction so that hemodynamic changes during induction can be monitored closely. Central venous access also is advisable to permit the rapid administration of vasoactive drugs as necessary. In patients with severe mitral stenosis and evidence of pulmonary hypertension, the placement of a pulmonary artery catheter can be helpful for allowing measurement of pulmonary artery pressures. If pulmonary artery pressures are greater than 50% of systemic pressure and right-sided heart failure is a concern, the pulmonary artery catheter measurements can help to guide therapy with drugs that lower pulmonary artery pressures—such as milrinone, nitric oxide, and iloprost. It should be noted, however, that no evidence-based medical guidelines exist to support the use of pulmonary artery catheterization to reduce morbidity or mortality. TEE—which can be performed when the patient is under general anesthesia—allows for a relatively rapid

Table 3. NYHA Classification System for Heart Failure Class

Symptoms

1

No limitation of activities

2

Slight, mild limitation of activities

3

Marked limitation of activities

4

Unable to carry out any physical activity without discomfort; symptoms at rest; complete rest required; patient confined to bed or chair

NYHA, New York Heart Association

assessment of both systolic and diastolic heart function in the hands of an experienced echocardiographer. It also helps to differentiate the common etiologies of hypotension, such as cardiac failure, decreased preload, and decreased afterload. If tricuspid regurgitation is detected, pulmonary artery pressures can be estimated using TEE without the need for pulmonary artery catheterization.

Management of the Case Presented Initial Evaluation of Patient The patient was transferred from a community hospital to an academic medical center. She was experiencing considerable dyspnea during any physical activity, and was unable to lie comfortably in the supine position (NYHA classification 4). She was immediately admitted to the cardiac care unit. She was started on metoprolol for heart rate control, and received the diuretic furosemide as needed. Soon after, a multidisciplinary team met to discuss a plan for her delivery and options for disease treatment during the remainder of her pregnancy. A cardiologist who evaluated the patient did not believe she was a candidate for PBMV due to the presence of significant mitral regurgitation. A cardiothoracic surgeon who also evaluated the patient was of the opinion that a valve replacement or repair was indicated; however, the surgeon felt that in this case such a procedure would involve an unacceptably high risk to the fetus. Finally, a plan was agreed for continued medical management and a planned cesarean delivery at 32 weeks gestational age. Induction of labor was not an option because of the presence of placenta previa. The plan allowed time to administer antenatal steroids with maximal benefit. Cesarean delivery was to be performed in the cardiac OR with a cardiac surgeon available, so that the patient could be placed on CPB emergently in the event of rapid decompensation. The plan was explained in detail to the patient and she gave informed consent. The high-risk obstetrics team requested an anesthesia consult. Cesarean Delivery A general anesthetic technique was selected and cesarean delivery performed in the cardiac OR with a cardiac surgery team on standby. The patient had been made aware of the unlikely possibility of an emergent sternotomy and valve repair. Preoperatively, the patient received 30 cc of sodium bicitrate. In the OR, the patient was placed on the operating table in a semirecumbent position with left uterine displacement (45 degrees). The obstetricians monitored the fetal

41


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CONTINUING MEDICAL EDUCATION

This lesson is available online at www.mssm.procampus.net

heart during anesthetic preparation. IV midazolam 2 mg was administered. A radial arterial line and pulmonary artery catheter were placed under local anesthesia. The patient’s initial systemic blood pressure was 125/65 mm Hg, with a mean pressure of 76 mm Hg. Heart rate was 105 beats per minute. Initial pulmonary pressures were 90/60 mm Hg, with mean pulmonary artery pressure of 62 to 68 mm Hg. The central venous pressure was 14 mm Hg, with a prominent v wave. Thermodilution cardiac output was not measured because of tricupsid regurgitation; however, initial mixed venous oxygen saturation was 34%. The patient was preoxygenated in the sitting position (at 45 degrees) to minimize discomfort. Etomidate, remifentanil, and succinylcholine were administered for a modified rapid-sequence induction.

Figure 2. Mid-esophageal 4-chamber view of mitral valve. Continuous wave Doppler across the valve allows for calculations of transvalvular pressure gradient, mitral valve pressure half-time, and estimated MVA. Mean PG, mean transvalvular pressure gradient; MVA, mitral valve area (estimated from P1/2T); P1/2T, mitral valve pressure half-time, milliseconds

The trachea was intubated successfully. An infusion of remifentanil 0.15 mcg/kg per minute was started. Isoflurane at less than 0.5 minimum alveolar concentration was administered. Depth of anesthesia was monitored, with a value maintained between 40 and 60 on the bispectral index. Pure oxygen was used to ventilate the patient. Normocarbia was vigilantly maintained to optimize pulmonary vascular resistance. TEE was performed intraoperatively, showing a mean pressure gradient of 16 mm Hg across the mitral valve, a mitral valve pressure half-time of 154 milliseconds, and an estimated mitral valve area of 1.43 cm2 (Figure 2). An explanation was given to the pediatric team—unfamiliar with the pharmacokinetics of remifentanil—that some opioid-induced respiratory depression would be observed immediately after birth, but the effects would be of short duration because of the predictable and short elimination half-life of the drug. As expected, after delivery the neonate required several minutes of positive pressure ventilation. Shortly thereafter, spontaneous respiration resumed and respiratory effort of the neonate was satisfactory. Apgar scores were 4 at 1 minute and 9 at 5 minutes. The obstetrics team completed the cesarean delivery, with the patient remaining hemodynamically stable throughout the procedure. She did not need any vasoactive infusions or blood transfusion. After the procedure, her trachea was extubated in the OR. Her postpartum course was uneventful. Three months after her delivery, the woman underwent a complex mitral valve repair with an excellent outcome.

F E B R U A R Y 2 0 11

however, the procedure is not successful in all cases and carries significant risk. Cardiac surgery can be performed during pregnancy with low risk to the mother, but the risk for fetal mortality is high. Epidural anesthesia, general anesthesia, or continuous intrathecal opioid techniques can be appropriate during delivery, but the advantages and disadvantages of each must be considered. Anesthesiologists should choose appropriate hemodynamic monitors and have a plan in place to manage rapid decompensation in the patient. With a well-coordinated and executed plan, the outcome is generally excellent for both mother and fetus.

References 1.

Perrino AC Jr, Reeves ST. A Practical Approach to Transesophageal Echocardiography. Philadelphia, PA: Lippincott, Williams, and Wilkins; 2003:189-201.

2.

Baumgartner H, Hung J, Bermejo J, et al. Echocardiographic assessment of valve stenosis: EAE/ASE recommendations for clinical practice. J Am Soc Echocardiogr. 2009;22(1):1-23.

3.

Herrmann HC, Kleaveland JP, Hill JA, et al. The M-heart percutaneous balloon mitral valvuloplasty registry: initial results and early follow-up; the M-Heart Group. J Am Coll Cardiol. 1990;15(6):1221-1226.

4.

Wilkins GT, Weyman AE, Abascal VM, Block PC, Palacios IF. Percutaneous balloon dilatation of the mitral valve: an analysis of echocardiographic variables related to outcome and the mechanism of dilatation. Br Heart J. 1988;60(4):299-308.

5.

Cruz-Gonzalez I, Sanchez-Ledesma M, Sanchez PL, et al. Predicting success and long-term outcomes of percutaneous mitral valvuloplasty: a multifactorial score. Am J Med. 2009;122(6):11-19.

6.

Patel A, Asopa S, Tang AT, Ohri SK. Cardiac surgery during pregnancy. Tex Heart Inst J. 2008;35(3):307-312.

7.

Vedrinne C, Tronc F, Martinot S, et al. Better preservation of endothelial function and decreased activation of the fetal renin-angiotensin pathway with the use of pulsatile flow during experimental fetal bypass. J Thorac Cardiovasc Surg. 2000;120(4):770-777.

8.

Koh KS, Friesen RM, Livingstone RA, Peddle LJ. Fetal monitoring during maternal cardiac surgery with cardiopulmonary bypass. Can Med Assoc J. 1975;112(9):1102-1104.

9.

Desai DK, Adanlawo M, Naidoo DP, Moodley J, Kleinschmidt I. Mitral stenosis in pregnancy: a four-year experience at King Edward VIII hospital, Durban, South Africa. BJOG. 2000;107(8):953-958.

Summary Mitral stenosis commonly manifests for the first time during pregnancy because of normally occurring hemodynamic changes that can exacerbate symptoms. When severe, the condition increases risks to the parturient and fetus. A multidisciplinary plan should be in place early because patients can decompensate at any time. Some patients may be candidates for PBMV during pregnancy;

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 Web site, call toll-free customer service at (888) 345-6788 or send an e-mail to Customer.Support@ProCEO.com.

For inquiries about course content only, send an e-mail to ram.roth@mssm.edu. Ram Roth, MD, is director of PreAnesthetic Assessment Online and assistant professor of anesthesiology at The Mount Sinai School of Medicine, New York, NY.

Post-Test 1. Which of the following is not a normal cardiovascular change during pregnancy? a. Increase in heart rate b. Decrease in systemic vascular resistance c. Decrease in ejection fraction d. Increase in blood volume

2. Which echocardiographic finding is consistent with severe mitral stenosis? a. Estimated MVA of 0.9 cm2 b. Mean transmitral gradient of 6 mm Hg c. Estimated MVA of 1.4 cm2 d. Mean transmitral gradient of 8 mm Hg

3. Which type of Doppler should be used to measure blood velocity across the mitral valve in a patient with mitral stenosis? a. Pulse wave b. Continuous wave c. Color flow d. M-mode

4. Which of the following is a reported complication of percutaneous balloon mitral valvuloplasty? a. Cardiac tamponade b. Death c. Systemic embolus d. All of the above

5. Which of the following is not a feature of the Wilkins mitral valvuloplasty score? a. Mobility b. Thickening c. Calcification d. Degree of mitral regurgitation

6. Hemodynamic goals in mitral stenosis include which of the following? a. Tachycardia b. Normal to high systemic vascular resistance c. Low preload d. High contractility

7. The approximate risk for fetal mortality during cardiopulmonary bypass is: a. 5% b. 20% c. 33% d. 50%

8. A patient with mitral stenosis can walk up 2 flights of stairs, but then has to stop for rest. She can walk approximately 4 blocks, but then becomes short of breath. In which New York Heart Association class would the patient be assigned? a. 1 b. 2 c. 3 d. 4

9. Which hemodynamic monitor is appropriate for a patient with severe mitral stenosis? a. Pulmonary artery catheter b. Transesophageal echocardiography c. Arterial catheter d. All of the above

10. In pregnant women with severe mitral stenosis, the most common complication is: a. fetal loss b. pulmonary embolus c. pulmonary edema d. death


FEBRUARY 2011

AnesthesiologyNews.com I 43

PA IN M E D ICIN E MYOFASCIAL

contrast, in the saline group, average 49-degree range of motion. VAS scores fell to 6, 6.6 and 5.1 at Dr. Younger noted that the disapto 100 units of Botox-A and eight one, four and six weeks, respectively. pointing results could be attributed subjects to receive a 2-cc solution of Average VAS scores, however, did to the fact that the subjects had saline in three trigger points along not differ significantly between the not responded to prior treatments one upper trapezius muscle. The two groups at eight and 12 weeks and thus might have had particu10 men and six women were aged following injections. Between larly recalcitrant forms of myofas44 to 80 years. All participants had six and eight weeks, the range of cial pain. He concluded that, “Although experienced inadequate relief from motion in both groups did not prior conservative treatments, and improve significantly. The Botox-A Botox-A was superior to saline in were asked not to receive adjunct group’s range of motion to the right reducing cervical myofascial pain, treatments for the 12-week study was 37 to 44.2 degrees, which was the average degree and durability of duration. similar to the saline group’s 39- to the pain relief was not sufficient to Investigators used the visual analog scale (VAS) to measure pain and pain on palpation, and also gauged muscle strength and cervical range of motion at one, two, four, six, eight and 12 weeks after administering the injections. Average VAS scores prior to treatment were 7.4 and 7.5 in the Botox-A and control groups, respectively, and the average range of motion to the right was 42 degrees in both groups. Dr. Satija and his team found the Botox-A group had significantly lower average VAS scores than the saline group at four and six weeks (P<0.05 for Botox-A vs. saline at four and six weeks). Specifically, in the Botox-A group, VAS scores dropped to 6 at one week, 4.5 at four weeks and 3.4 at six weeks. In

ANALGESICS

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CONTINUED FROM PAGE 37

defects in the Finnish cohort. The authors suggested this result may be explained by the lower overall incidence of cryptorchidism and lower per capita sale of paracetamol in Finland compared with Denmark. “More investigation is urgently needed to understand the effects of analgesics on the lifetime incidence of reproductive health disorders,” Dr. Leffers said. “We are following the boys in our cohorts as they enter puberty.” Eduardo M. Fraifeld, MD, president of the American Academy of Pain Medicine, found the results concerning, but pointed out that the risks of using these medications may be preferable to the effects of untreated pain. “No treatment is absolutely safe,” said Dr. Fraifeld, who was not involved in the study. “But when more benign approaches like heat and cold application or physical therapy don’t work, you need to consider that leaving pain untreated can lead to decreased activity, physical deconditioning and other problems.” —David Wild

recommend using it as a first-line treatment for the condition.” Dr. Satija echoed Dr. Younger’s comments and concluded that Botox-A merits a place further down the chain of treatment for myofascial pain. “Due to unsustained pain relief, as well as higher cost and discomfort, Botox-A should be left for chronic patients who are resistant to conventional treatments,” he said. —David Wild


44 I AnesthesiologyNews.com

FEBRUARY 2011

C A R E E R O P P O R TU NITIES

Position Available:

Director of Pediatric Anesthesia The North Shore-LIJ Health System is currently seeking a Director of Pediatric Anesthesiology for The North Shore-LIJ Health System is currently seeking a Director of Pediatric Anesthesiology for The Cohen Childrenâ&#x20AC;&#x2122;s Medical Center. The Medical Center is undergoing significant expansion with The Cohen Childrenâ&#x20AC;&#x2122;s Medical Center. The Medical Center is undergoing significant expansion with 50 new patient care beds and eight new pediatric ORs. The Director of Pediatric Anesthesiology will lead a division 50 new patient care beds and eight new pediatric ORs. The Director of Pediatric Anesthesiology will lead a division responsible for a busy clinical service, research, resident education and medical student education as part of the new responsible for a busy clinical service, research, resident education and medical student education as part of the new NSLIJ-Hofstra University School of Medicine. The candidate should be fellowship trained or equivalent, NSLIJ-Hofstra University School of Medicine. The candidate should be fellowship trained or equivalent, BC in Anesthesia with a minimum of 5-10 years experience in clinical research, education or pediatric anesthesia. BC in Anesthesia with a minimum of 5-10 years experience in clinical research, education or pediatric anesthesia. Please submit your interest to: Please submit your interest to:

Dr. Dr. John John DiCapua DiCapua Chairman, Department Chairman, Department of of Anesthesiology Anesthesiology Jdicapua@NSHS.edu or fax 516-945-3141 Jdicapua@NSHS.edu or fax 516-945-3141


AnesthesiologyNews.com I 45

FEBRUARY 2011

CA R E E R OPPOR TU N ITIE S

NAPA is seeking a Pediatric Anesthesiologist at Cohen Children’s Medical Center, part of the NSLIJ Health System. North American Partners in Anesthesia not only offers great benefits, but also a rewarding career path. Some advantages of a position with NAPA are: • Physician-owned and led • Advancement opportunities • Innovative and highly competitive compensation package

Booth # 123 & 124 at PGA

Benefits of the NSLIJ Health System: • Integral Faculty of the new NSLIJ Hofstra University School of Medicine • Cohen Children’s Medical Center provides a full range of pediatric services including a pediatric Level I Trauma Center program, and busy, high risk OB and neonatal services. • Flexibility to participate in adult anesthesia services Please submit your CV to: Jeanne Wagner, Director of Clinical Recruitment jwagner@NAPAanesthesia.com Ph: 516-945-3096 • Fax: 516-626-6446

South Jersey South Jersey ASC specializing in abortion care. Days only; no night call. Part-time and full-time, Tues.-Sat. Anesthesiologists sought for busy ASC in Cherry Hill, N.J. Be a part of a superior, professional team of specialized physicians, nurse practitioners, registered nurses and experienced and dedicated medical, counseling and administrative support staff. We are seeking full-time or part-time daytime coverage for our abortion surgery practice Tuesdays through Saturdays, daytime only, no night call.

Cherry Hill Women’s Center (CHWC) is nationally recognized as a model of excellence in women’s health and abortion care, and has offered services for over 30 years. CHWC is accredited by the National Abortion Federation, is AAASC-certified and is a member of the AAAASF. Candidates must hold New Jersey license, board certification, DEA, CDS, PALS/ACLS.

Interested parties should contact Elaina Nordo, administrator. E-mail: enordo@ cherryhillwomenscenter.com; Fax: (856) 356-4039; Phone (856) 667-5910.

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46 I AnesthesiologyNews.com

FEBRUARY 2011

C OMM E NT A R Y

Mind-reading and Other Mentoring Pitfalls

H

ave you ever felt as though you had to read your boss’s mind to understand what he or she wanted you to do? How often have you gotten to the end of a project, only to find that this is not exactly what your boss had in mind? You then have to retrench, regroup and try it again. Sadly, this is not uncommon. Poor communication often results in unclear expectations. When this occurs between a boss and a subordinate, it causes mutual frustration, further breakdowns of communication and an erosion of trust. I would suggest that we cannot afford to operate this way any longer. New financial constraints require us to work smarter and more efficiently. We need new systems that encourage efficiency. This efficiency not only adds to a company’s (or hospital’s) bottom line, it also promotes a team-like atmosphere and greater employee satisfaction. So, how do we get there? One approach is “accountability leadership.” Although accountability leadership is often associated with assigning blame to people, this is a mistaken impression. Assigning responsibility (ownership) is a far cry from handing out blame. Knowing what we are being held accountable for brings certainty and confidence. Over the next few months of this column, I’d like to demonstrate how. At the same time, with the use of a framework shaped by the principles in the

Leverage. The manager’s role is to leverage the creative capabilities of their employees to maximize their contributions to the overall goals of the organization. When people are recognized for their expertise in particular areas and use that expertise to influence others and accomplish significant objectives, the result is a high level of satisfaction. This includes playing to people’s individual strengths to create a complementary team of professionals. This also acknowledges that you as a manager could not accomplish these goals on your own. Rather, you need a team of people who have diverse abilities and expertise that you don’t possess in order to get the job done. When the manager can engage people and align their expertise with the stated goals, it is sure to result in employee success and personal development. Engagement. I have stated in this column many times, the wise manager seeks to win the minds and the hearts of his or her employees through engaging their full commitment. Coercion and autocratic rule are ineffective. There is often an unwritten contract between the effective manager and the employees when the employees know the manager has their best interest at heart and will help them accomplish the goals. By engaging the LEAD People employees, the commitment becomes a Kraines suggests that managers use the two-way street. acronym LEAD as a formula for buildAlignment. When employees undering a culture of accountability: stand the significance of their roles in the

book “Accountability Leadership,” by Gerald Kraines (Pompton Plains, NJ: Career Press; 2001), I will show you how to create this type of environment in your own workplace. Ernest R. Anderson Jr., MS, RPh Kraines defines accountability as “the obligation of an employee to deliver all elements of the value that he or she is being compensated for delivering, as well as the obligation to deliver on specific output commitments with no surprises.” A worthy goal, but how can we make it happen? One of the first steps is to set goals with employees—encouraging their buy-in—then stepping back and allowing them to execute. The manager must give authority commensurate with the accountability. This gives the employee the opportunity to make creative decisions to get the job completed. In turn, this results in feelings of ownership (within the bounds of parameters of the project) and freedom.

organization (and “have permission” to act on that understanding), there is alignment. The employee also needs to understand how his or her position relates to the others in the department and organization as well. I have often encouraged pharmacists to think about their role as it aligns with broader national goals and institutional goals within health care. Health care reform provides opportunities for pharmacists to help patients improve their health and reduce costs. By understanding the incentives and determining how pharmacists can play a key role, we align ourselves. Institutionally, it is the managers’ responsibility to help their employees and upper management understand this alignment. Development. As Kraines states, “Managers must be held accountable for effectively developing their people.” As Ken Blanchard, author of “The Servant Leader” (Nashville, TN: J. Countryman; 2003) says, two marks of a servant leader are how he or she handles feedback and succession planning. Developing others shows an interest in the employee and helps to develop a mutual sense of trust and loyalty. Mentoring others must be intentional and not just “when you get around to it.” —Ernest R. Anderson Jr., MS, RPh, System Vice President of Pharmacy, Caritas Christi, Boston. Mr. Anderson welcomes your input on leadership issues, at ernest.anderson@caritaschristi.org.

CLIPCHART Aurora, CO: Maternal mortality linked to anesthesia fell by nearly 60% between 1979 and 2002, to just over one case per million live births, according to a new study by researchers at the University of Colorado. But the study, led by anesthesiologist Joy Hawkins, MD, found that deaths related to general anesthesia accounted for all of the decline, while deaths attributed to regional anesthesia have risen slightly. The two techniques now appear to be equally safe during labor, according to the findings, which appeared in the January 2011 issue of Obstetrics & Gynecology (117;69-74).

Victoria, B.C.: Angela Enright, MD, of Victoria, B.C., received the title of Officer of the Order of Canada, the country’s second highest, for her work training anesthesiologists throughout the world. Born in Dublin, Ireland, Dr. Enright is president of the World Federation of Societies of Anesthesiologists and a pastpresident of the Canadian Anesthesiologists’ Society. Much of her work has involved “capacity building” in developing countries such as Rwanda, where she has helped raise the number of anesthesiologists from one in in 2006 to nine.

Rockville, MD: The FDA is seeking guidance from academic anesthesiologists and others to improve the understanding of how sedatives work in patients. The agency said the initiative— which could drive the development of new drugs—was not a response to the ongoing shortage of propofol and other sedatives, but rather “was undertaken due to the poor quality of the studies we receive for sedative drug products” and a lack of internal expertise to conduct such research itself. The FDA said it will collect public comments on the sedation initiative through Jan. 28, 2011.


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