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40th Anniversary 1972-2012
Fully Robotic Nerve Blocks on the Horizon
Fujii Inquiry Finds Fraud In at Least 172 Studies
I
Only three of 212 papers with real data; rest uncertain
t sounds like a snarky joke some surgeons might tell, but administering regional anesthesia may no longer require a brain—or even hands. Canadian inventors have created a robotic, ultrasound-guided system for delivering nerve blocks. In a recent study, they said, the robot, called Magellan, scored a 100% success rate for blocks when clinicians assisted with the procedure. But the researchers are developing a computer algorithm that can eliminate the need for human interaction. “This study and this device are world firsts,” Thomas Hemmerling, MD, lead developer of the robotic system, told
J
apanese investigators have concluded that Yoshitaka Fujii, MD, an expert in postoperative nauseea and vomiting whose findings ddrew scrutiny in 2000 but who coontinued to publish prolifically for a decade after, fabricated his results in n at least 172 published studies. An inquiry by the Japanese Society oof A Anesthesiologists ( JSA) has determin ned that Dr. Fujii, who in February was firred from his post at Toho University, fallsified data in 172 of 212 papers publiisheed between 1993 and 2011.
see magellan page 12
see fujii page 16
OB Anesthesia Gains Pedigree With Fellowships
INSIDE
A
46 | PAIN MEDICINE
subspecialty is being born. As of April, 11 of the nation’s three dozen obstetric anesthesiology fellowships have received official recognition from the Accreditation Council for Graduate Medical Education. The fellowships received initial accreditation at a meeting of the council’s Residency Review Committee in anesthesiology, making obstetric anesthesia the fifth subspecialty. Obstetric anesthesiology training has been available without accreditation for decades. The program at Brigham and Women’s Hospital, in Boston, for instance, which is applying for 2013 accreditation, has been in place for more than 25 years. But over the past 10 years the push for accreditation has
09 | CLINICAL ANESTHESIOLOGY Leaky valves linked to post-op success.
taken place, said McCallum Hoyt, MD, MBA, assistant professor of anesthesiology at the Brigham and president of the Society for Obstetric Anesthesia and Perinatology (SOAP), which led the effort. “Choosing to become accredited was based on the recognition that we did have a unique body of knowledge,” she said. “Now we can standardize what it is we’re offering when we say ‘OB fellowship.’” Michael G. Richardson, MD, who directs the obstetric anesthesiology fellowship at Vanderbilt see ob fellow page 14
During spinal surgery, monitor the cord for signs of trouble.
56 | COMMENTARY Inside the OIG’s fee-sharing dictate.
58 | AD LIB Sweet kisses and hammer blows—a history of self-experimentation in anesthesia (Part 2).
CME: PREANESTHETIC ASSESSMENT Lesson 299: PreAnesthetic Assessment of the Patient With Acute Ischemic Stroke, see page 50.
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1. Report: Japanese Anesthesiologist Fabricated Data in 172 Studies 2. Residual Paralysis: The Problem That Won’t Go Away 3. Tissue-Engineering Anesthesiologist Redefines Stem Cells 4. Femoral Blocks a Boon for Hip, Knee Surgery 5. Years in the Making, FDA Approves REMS for Long-acting, Extended-Release Opioids
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AnesthesiologyNews.com I 7
AUGUST 2012
COR R E SPON D E N CE
Expert Witness Committee—a Response To the Editor,
W
ith regard to our article “‘Aliens Among Us’: The Perils of Expert Witness Testimony” ((Anesthesiology News March 2012, pages 24-26), we completely agree with Dr. Eckmann that “the process that the ASA [American Society of Anesthesiologists] has undertaken to address the matter [of expert witness testimony] was broken from the outset. The current program should be dismantled” (Anesthesiology ( News May 2012, page 7). We completely disagree with Drs. Unruh and Cohen’s letter on this matter ((Anesthesiology News June 2012, page 6), for several reasons. First, Drs. Unruh and Cohen—despite their intimate familiarity with the ASA Committee on Expert Witness Testimony Review (CEWTR), the entire ASA Expert Witness Testimony Review Program and the ASA’s mandatory rules of strict confidentiality to protect accused experts—chose to respond to suggestions of bad faith and bias by mischaracterizing specific facts (the purported “tag-teaming”) about a completely separate, distinct and confidential CEWTR matter that was not the subject of our original article. This egregious breach of confidentiality not only results in a defamatory de facto sanction against Dr.
[ J.L.] Benumof, which clearly violates Dr. Benumof ’s due process rights, among others, and raises questions, given that Drs. Unruh and Cohen are fully aware that all allegations and complaints against Dr. Benumoff were ultimately dismissed. Second, while Drs. Unruh and Cohen make a vague and ambiguous reference to purported permissible “dialogue with the hearing panel [i.e., the CEWTR]”, they fail to reference even a single bylaw or written procedural rule that governs or allows cross-examination of the CEWTR, which presides r judge and jury over the review process as fact-finder, (up until the Judicial Council and Board of Director levels of review). What’s more, it is fundamentally impossible for the CEWTR to fairly preside over questioning of an investigator, who is merely a subservient arm of the CEWTR, because by the time the CEWTR hearings take place, the CEWTR has already determined, by ASA rules and regulations, that “there is a substantial question” that the accused expert “failed to abide by the [ASA] Guidelines” [on expert witness testimony] (ASA Administrative Procedures 2011 11.8.3.2). Ultimately, an exchange of letters-to-the-editor cannot settle the differences in opinion between Drs. Unruh and Cohen and ourselves regarding
built-in bias by the ASA CEWTR; however, we strongly believe that review of transcripts by a state or federal court would prove us correct. Third, Drs. Unruh and Cohen state that our article “contains a host of inaccuracies and biased interpretations of case law” as well as “patent falsehoods.” However, since Drs. Unruh and Cohen fail to support their capricious accusations with any analysis of why our description of the case law is “inaccurate” or “biased,” choosing instead to only mischaracterize strictly confidential proceedings, almost all of their criticism is simply innuendo and insinuation. Indeed, our article plainly and transparently cites case law on both sides of the “immunity” issue and accurately summarizes the very few written procedural rules that actually govern the CEWTR program. Finally, we look forward to continuing debate in forums with a level playing field on how to best ensure expert witness testimony is honest, unbiased and responsible. —Jonathan L. Benumof, MD, and Benjamin T. Benumof, PhD, Esq Jonathan L. Benumof, MD, is professor of anesthesiology at the University of California, San Diego. Benjamin T. Benumof, PhD, Esq, is an attorney in San Clemente, Calif.
State of the Nation: Methadone Overdoses Surged Since 1999
T
he rate of deadly methadone overdoses spiked dramatically over the past decade, according to new data from the U.S. Centers
3.0
for Disease Control and Prevention. Fatalities linked to excessive use of the drug rose more than fivefold between 1999 and 2010 (Figure 1).
Methadone now accounts for nearly 10% of opioid precriptions for pain, the agency found (Figure 2).
Methadone use for pain (kg/100,000 persons) Methadone-related overdose deaths per 100,000 persons Methadone prescriptions for pain per 100 persons
2.5
Rate
2.0
1.5
1.0
0.5
0
11.5-18.5 8.6-11.4 6.7-8.5 4.4-6.6
1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010
Year Figure 1. Overdose deaths involving methadone in the United States rose more than fivefold between 1999 and 2010 but appear to be coming down.
Figure 2. Methadone accounted for approximately 9% of all morphineequivalent prescriptions for pain in 2010, according to the Centers for Disease Control and Prevention. The proportion ranged from 4.5% in New Jersey to 18.5% in Washington.
8 I AnesthesiologyNews.com
AUGUST 2012
C LIN I C A L A N ES THES IO LO G Y
Ultrasound Proves Good Means of ID-ing Pneumothorax
U
ltrasound can detect signs of intrapleural air that reliably indicate the presence of a pneumothorax, according to a recent study that suggests anesthesiologists might want to consider using the scanning technology more frequently to find the potentially life-threatening complication. “I believe many anesthesiologists
are a bit afraid of using ultrasound because we’re not quite sure where to start with the probe,” said Sean Kiley, MD, anesthesiology fellow at the University of Florida, in Gainesville. “I thought maybe we can define a single landmark where the probe can be placed and know with a fair degree of certainty that either there is or isn’t a pneumothorax.”
Dr. Kileyy and his colleagues identified all patients with a diagnosed pneumothorax at their institution between December 2006 and January 2010. Of those, 94 had undergone helical chest computed tomography scans that were available for examination. “Once we got to our sample of 94 patients, we asked our radiology colleagues to help us. They created
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some 3D [threedimensional] reconfor structions ultrasound.” Computer software calculated the cephalic, caudal, medial and lateral borders of each pneumothorax. Sean Kiley, MD “I was fairly surprised to find that almost every pneumothorax that we looked at extended and connected to the sternum,” Dr. Kileyy said. “Once we figured that out, it was pretty easy to determine which rib interspaces are the most likely to show pneumothoraces.” The analysis found that lateral border of each pneumothorax averaged 11.35 cm (±3.32 cm) from midline; the cephalic and caudal borders ranged from apex to diaphragm. Rib interspace 4 to 5 had the highest frequency of intrapleural air present (Figure). Intrapleural air was present in various rib interspaces. “The pneumothoraces that we did not see along rib interspaces 3 to 6 on the parasternal border were tiny; the volumes were less than 20 ccs,” Dr. Kileyy explained. “So those pneumothoraces were largely clinically insignificant.” The position of the heart creates a difference in the contour of the left and right sides, he noted. “In any case, we mapped out the location of the pneumothoraces and found they existed in about the same spot on either side of the chest,” he said. These results should help anesthesiologists better locate pneumothoraces quickly and efficiently, Dr. Kileyy said. “There is a nice screening exam called the eFAST. It’s a good start. However, we found we have a higher diagnostic sensitivity along the parasternal border at interspaces 3 through 6,” he said. The investigators are currently validating their results. Dr. Kileyy recognized that anesthesiologists who use ultrasound are already adept at diagnosing pneumothorax; as a result, they might not be the ones who benefit most from this research. His goal, he said, is to convince other anesthesiologists to use the technology. “I don’t think people understand that you can place an ultrasound probe between interspaces 3 and 6 and can be very effective in diagnosing pneumothorax,” he said. “So by offering these data, my hope is that people see pneumothorax page 10
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AnesthesiologyNews.com I 9
AUGUST 2012
CL IN ICA L A N E STH E SIOL OG Y
Tricuspid Leaks After Mitral Valve Repair Worsen Outcomes
U
ncorrected tricuspid regurgitation is independently associated with adverse long-term outcomes after mitral valve surgery, resulting in markedly lower survival rates more than one year after the procedure, researchers have found. In light of these findings, the investigators suggested that surgical correction of significant tricuspid regurgitation seriously be considered in mitral valve surgery patients. “We know that tricuspid regurgitation is an independent predictor of adverse outcomes in several surgical settings, and that patients with significant tricuspid regurgitation can develop complications of increased systemic venous pressure and subsequent organ dysfunction,” said Madhav Swaminathan, MD, associate professor of anesthesiology at Duke University School of Medicine, in Durham, N.C. “However, tricuspid regurgitation is rarely surgically corrected during mitral valve surgery, unless it is actually severe. And the prognostic impact of uncorrected tricuspid regurgitation in this setting is not clear.” The investigators gathered data on 871 adults undergoing isolated mitral valve surgery (with or without coronary artery bypass graft) or aortic valve replacement at Duke, between 2001 and 2010. The severity of tricuspid
regurgitation—none, mild, moderate or severe—was graded by an attending anesthesiologist using intraoperative echocardiography (Figure). An independent observer later verified the score. Patients were then classified as having either insignificant (no or mild) tricuspid regurgitation or significant (moderate or severe) tricuspid regurgitation.
Adverse outcomes were defined as a composite event comprising at least one of the following postoperative complications: myocardial infarction, repeat cardiac surgery or all-cause mortality. The researchers identified 400 adverse events over a median followup period of 747 days. They observed strong associations between significant tricuspid regurgitation and adverse
events (hazard ratio [HR],1.97; 95% confidence interval [CI], 1.4-2.7; P<0.0001), as well as cardiopulmonary bypass time and such episodes (HR, 1.0; 95% CI, 1.0-1.0; P=0.002). Patients with significant tricuspid regurgitation also had significantly worse event-free survival than those with insignificant regurgitation (Table). see correct page 10
P Value
95% Confidence Interval
Hazard Ratio
Variable
Table. Cox Proportional Hazards Model
Significant 1.970 1.436 2.704 <0.0001 tricuspid regurgitation Coronary Bypass
1.158 0.933 1.437 0.1829
Aortic valve 1.046 0.933 1.173 0.4380 replacement Bypass Time 1.003 1.001 1.004 0.0018
NAROPIN® was associated with more spontaneous vaginal deliveries and fewer instrumented deliveries than bupivacaine.1-3 A Block Well Done. An 18% higher proportion of spontaneous vaginal deliveries and a 32% lower proportion of instrumented deliveries were observed in patients who received 2 NAROPIN vs bupivacaine (P<0.05; P P P<0.01). To learn more about the clinical benefits of NAROPIN in labor and delivery, visit www.naropin-us.com.
Using NAROPIN beyond recommended doses to increase motor block or duration of sensory block may negate its favorable cardiovascular advantages, in the event that an inadvertent intravascular injection occurs. Like all amide-type local anesthetics, NAROPIN may be associated with adverse reactions. In clinical trials, side effects were mild and transient and may reflect the procedures, patient health status, and/or other medications used. Adverse events reported at a rate of ≥5%: hypotension, nausea, vomiting, bradycardia, fever, pain, postoperative complications, anemia, paresthesia, headache, pruritus, and back pain. Important Safety Information There have been adverse event reports of chondrolysis in patients receiving intra-articular infusions of local anesthetics following arthroscopic and other surgical procedures. NAROPIN is not approved for this use. Please see dosage and administration details in Prescribing Information at www.naropin-us.com. Please see accompanying brief summary of Prescribing Information. www.naropin-us.com
Figure. Color flow Doppler scan of the tricuspid valve imaged at 90 degrees. Image courtesy of Wanda Popescu, MD.
NAROPIN is indicated for the production of regional or local anesthesia for surgery and for acute pain management. 1. NAROPIN Prescribing Information. Data on file. 2. Writer WDR, Stienstra R, Eddleston JM, et al. Neonatal outcome and mode of delivery after epidural analgesia for labour with ropivacaine and bupivacaine: a prospective meta-analysis. Br J Anaesth. 1998;81:713717. 3. Asik I, Göktug A, Gülay I, Alkis N, Uysalel A. Comparison of bupivacaine 0.2% and ropivacaine 0.2% combined with fentanyl for epidural analgesia during labour. Eur J Anaesthesiol.l 2002;19:263-270. Naropin® and logo are registered trademarks of APP Pharmaceuticals, LLC. and APP ® are registered trademarks of APP Pharmaceuticals, LLC. ©2011, APP Pharmaceuticals, LLC. All Rights Reserved. 0173-NAR-05-4/11
WHY COMPROMISE?
10 I AnesthesiologyNews.com
AUGUST 2012
C LIN I C A L A N ES THES IO LO G Y PNEUMOTHORAX
CONTINUED FROM PAGE 8
will be more progressive in utilizing ultrasound.” D. John Doyle, MD, PhD, professor of anesthesiology at the Cleveland Clinic Lerner College of Medicine of Case Western Reserve University in Ohio, called the study “very interesting” and “potentially very important.” “As ultrasound continues to make a special place for itself in routine anesthesia practice, I expect that we will see
Figure. Axial, coronal and sagittal images, accompanied by a three dimensional reconstruction, used to accurately map the location of intrapleural air.
Naropin
®
(ropivacaine HCl) Injection BRIEF SUMMARY INDICATIONS AND USAGE Naropin is indicated for the production of local or regional anesthesia for surgery and for acute pain management. Surgical Anesthesia: epidural block for surgery including cesarean section; major nerve block; local infiltration. Acute Pain Management: epidural continuous infusion or intermittent bolus, e.g., postoperative or labor; local infiltration. CONTRAINDICATIONS Naropin is contraindicated in patients with a known hypersensitivity to ropivacaine or to any local anesthetic agent of the amide type. WARNINGS In performing Naropin blocks, unintended intravenous injection is possible and may result in cardiac arrhythmia or cardiac arrest. The potential for successful resuscitation has not been studied in humans. There have been rare reports of cardiac arrest during the use of Naropin for epidural anesthesia or peripheral nerve blockade, the majority of which occurred after unintentional accidental intravascular administration in elderly patients and in patients with concomitant heart disease. In some instances, resuscitation has been difficult. Should cardiac arrest occur, prolonged resuscitative efforts may be required to improve the probability of a successful outcome. Naropin should be administered in incremental doses. It is not recommended for emergency situations, where a fast onset of surgical anesthesia is necessary. Historically, pregnant patients were reported to have a high risk for cardiac arrhythmias, cardiac/ circulatory arrest and death when 0.75% bupivacaine (another member of the amino amide class of local anesthetics) was inadvertently rapidly injected intravenously. Prior to receiving major blocks the general condition of the patient should be optimized and the patient should have an i.v. line inserted. All necessary precautions should be taken to avoid intravascular injection. Local anesthetics should only be administered by clinicians who are well versed in the diagnosis and management of dose-related toxicity and other acute emergencies that may arise from the block to be employed, and then only after ensuring the immediate (without delay) availability of oxygen, other resuscitative drugs, cardiopulmonary resuscitative equipment, and the personnel resources needed for proper management of toxic reactions and related emergencies (See also ADVERSE REACTIONS, PRECAUTIONS, and MANAGEMENT OF LOCAL ANESTHETIC EMERGENCIES). Delay in proper management of dose-related toxicity, underventilation from any cause, and/or altered sensitivity may lead to the development of acidosis, cardiac arrest and, possibly, death. Solutions of Naropin should not be used for the production of obstetrical paracervical block anesthesia, retrobulbar block, or spinal anesthesia (subarachnoid block) due to insufficient data to support such use. Intravenous regional anesthesia (bier block) should not be performed due to a lack of clinical experience and the risk of attaining toxic blood levels of ropivacaine. Intra-articular infusions of local anesthetics followingg arthroscopic p and other surgical g procedures p is an unapproved pp use,, and there have been post-marketing p g reports p of chondrolysis y in patients p receivingg such infusions. The majority j y of reported p cases of chondrolysis y have involved the shoulder jjoint;; cases of ggleno-humeral chondrolysis y have been described in ppediatric and adult ppatients followingg intra-articular infusions of local anesthetics with and without eppinephrine p for pperiods of 48 to 72 hours. There is insufficient information to determine whether shorter infusion periods p are not associated with these findings. g The time of onset of symptoms, y p , g y Currently,y, there is no effective treatment such as jjoint ppain,, stiffness and loss of motion can be variable,, but mayy begin g as earlyy as the 2nd month after surgery. for chondrolysis; y ; ppatients who experienced p chondrolysis y have required q additional diagnostic g and therapeutic p pprocedures and some required q arthroplasty p y or shoulder replacement. p It is essential that aspiration for blood, or cerebrospinal fluid (where applicable), be done prior to injecting any local anesthetic, both the original dose and all subsequent doses, to avoid intravascular or subarachnoid injection. However, a negative aspiration does nott ensure against an intravascular or subarachnoid injection. A well-known risk of epidural anesthesia may be an unintentional subarachnoid injection of local anesthetic. Two clinical studies have been performed to verify the safety of Naropin at a volume of 3 mL injected into the subarachnoid space since this dose represents an incremental epidural volume that could be unintentionally injected. The 15 and 22.5 mg doses injected resulted in sensory levels as high as T5 and T4, respectively. Anesthesia to pinprick started in the sacral dermatomes in 2-3 minutes, extended to the T10 level in 10-13 minutes and lasted for approximately 2 hours. The results of these two clinical studies showed that a 3 mL dose did not produce any serious adverse events when spinal anesthesia blockade was achieved. Naropin should be used with caution in patients receiving other local anesthetics or agents structurally related to amide-type local anesthetics, since the toxic effects of these drugs are additive. Patients treated with class III antiarrhythmic drugs (e.g., amiodarone) should be under close surveillance and ECG monitoring considered, since cardiac effects may be additive. PRECAUTIONS: General: The safe and effective use of local anesthetics depends on proper dosage, correct technique, adequate precautions and readiness for emergencies. Resuscitative equipment, oxygen and other resuscitative drugs should be available for immediate use. (See WARNINGS and ADVERSE REACTIONS.) The lowest dosage that results in effective anesthesia should be used to avoid high plasma levels and serious adverse events. Injections should be made slowly and incrementally, with frequent aspirations before and during the injection to avoid intravascular injection. When a continuous catheter technique is used, syringe aspirations should also be performed before and during each supplemental injection. During the administration of epidural anesthesia, it is recommended that a test dose of a local anesthetic with a fast onset be administered initially and that the patient be monitored for central nervous system and cardiovascular toxicity, as well as for signs of unintended intrathecal administration before proceeding. When clinical conditions permit, consideration should be given to employing local anesthetic solutions, which contain epinephrine for the test dose because circulatory changes compatible with epinephrine may also serve as a warning sign of unintended intravascular injection. An intravascular injection is still possible even if aspirations for blood are negative. Administration of higher than recommended doses of Naropin to achieve greater motor blockade or increased duration of sensory blockade may result in cardiovascular depression, particularly in the event of inadvertent intravascular injection. Tolerance to elevated blood levels varies with the physical condition of the patient. Debilitated, elderly patients and acutely ill patients should be given reduced doses commensurate with their age and physical condition. Local anesthetics should also be used with caution in patients with hypotension, hypovolemia or heart block. Careful and constant monitoring of cardiovascular and respiratory vital signs (adequacy of ventilation) and the patient’s state of consciousness should be performed after each local anesthetic injection. It should be kept in mind at such times that restlessness, anxiety, incoherent speech, light-headedness, numbness and tingling of the mouth and lips, metallic taste, tinnitus, dizziness, blurred vision, tremors, twitching, depression, or drowsiness may be early warning signs of central nervous system toxicity. Because amide-type local anesthetics such as ropivacaine are metabolized by the liver, these drugs, especially repeat doses, should be used cautiously in patients with hepatic disease. Patients with severe hepatic disease, because of their inability to metabolize local anesthetics normally, are at a greater risk of developing toxic plasma concentrations. Local anesthetics should also be used with caution in patients with impaired cardiovascular function because they may be less able to compensate for functional changes associated with the prolongation of A-V conduction produced by these drugs. Many drugs used during the conduct of anesthesia are considered potential triggering agents for malignant hyperthermia (MH). Amide-type local anesthetics are not known to trigger this reaction. However, since the need for supplemental general anesthesia cannot be predicted in advance, it is suggested that a standard protocol for MH management should be available. Epidural Anesthesia: During epidural administration, Naropin should be administered in incremental doses of 3 to 5 mL with sufficient time between doses to detect toxic manifestations of unintentional intravascular or intrathecal injection. Syringe aspirations should also be performed before and during each supplemental injection in continuous (intermittent) catheter techniques. An intravascular injection is still possible even if aspirations for blood are negative. During the administration of epidural anesthesia, it is recommended that a test dose be administered initially and the effects monitored before the full dose is given. When clinical conditions permit, the test dose should contain an appropriate dose of epinephrine to serve as a warning of unintentional intravascular injection. If injected into a blood vessel, this amount of epinephrine is likely to produce a transient “epinephrine response” within 45 seconds, consisting of an increase in heart rate and systolic blood pressure, circumoral pallor, palpitations and nervousness in the unsedated patient. The sedated patient may exhibit only a pulse rate increase of 20 or more beats per minute for 15 or more seconds. Therefore, following the test dose, the heart should be continuously monitored for a heart rate increase. Patients on beta-blockers may not manifest changes in heart rate, but blood pressure monitoring can detect a rise in systolic blood pressure. A test dose of a shortacting amide anesthetic such as lidocaine is recommended to detect an unintentional intrathecal administration. This will be manifested within a few minutes by signs of spinal block (e.g., decreased sensation of the buttocks, paresis of the legs, or, in the sedated patient, absent knee jerk). An intravascular or subarachnoid injection is still possible even if results of the test dose are negative. The test dose itself may produce a systemic toxic reaction, high spinal or epinephrine-induced cardiovascular effects. Use in Brachial Plexus Block: Ropivacine plasma concentrations may approach the threshold for central nervous system toxicity after the administration of 300 mg of ropivacaine for brachial plexus block. Caution should be exercised when using the 300 mg dose. (See OVERDOSAGE.) The dose for a major nerve block must be adjusted according to the site of administration and patient status. Supraclavicular brachial plexus blocks may be associated with a higher frequency of serious adverse reactions, regardless of the local anesthetic used. Use in Peripheral Nerve Block: Major peripheral nerve blocks may result in the administration of a large volume of local anesthetic in highly vascularized areas, often close to large vessels where there is an increased risk of intravascular injection and/or rapid systemic absorption, which can lead to high plasma concentrations. Use in Head and Neck Area: Small doses of local anesthetics injected into the head and neck area may produce adverse reactions similar to systemic toxicity seen with unintentional intravascular injections of larger doses. The injection procedures require the utmost care. Confusion, convulsions, respiratory depression, and/or respiratory arrest, and cardiovascular stimulation or depression have been reported. These reactions may be due to intra-arterial injection of the local anesthetic with retrograde flow to the cerebral circulation. Patients receiving these blocks should have their circulation and respiration monitored and be constantly observed. Resuscitative equipment and personnel for treating adverse reactions should be immediately available. Dosage recommendations should not be exceeded. (See DOSAGE AND ADMINISTRATION.) Use in Ophthalmic Surgery: The use of Naropin in retrobulbar blocks for ophthalmic surgery has not been studied. Until appropriate experience is gained, the use of Naropin for such surgery is not recommended. Drug Interactions: Specific trials studying the interaction between ropivacaine and class III antiarrhythmic drugs (e.g., amiodarone) have not been performed, but caution is advised (see WARNINGS). Naropin should be used with caution in patients receiving other local anesthetics or agents structurally related to amide-type local anesthetics, since the toxic effects of these drugs are additive. Cytochrome P4501A2 is involved in the formation of 3-hydroxy ropivacaine, the major metabolite. In vivo, the plasma clearance of ropivacaine was reduced by 70% during coadministration of fluvoxamine (25 mg bid for 2 days), a selective and potent CYP1A2 inhibitor. Thus strong inhibitors of cytochrome P4501A2, such as fluvoxamine, given concomitantly during administration of Naropin, can interact with Naropin leading to increased ropivacaine plasma levels. Caution should be exercised when CYP1A2 inhibitors are coadministered. Possible interactions with drugs known to be metabolized by CYP1A2 via competitive inhibition such as theophylline and imipramine may also occur. Coadministration of a selective and potent inhibitor of CYP3A4, ketoconazole (100 mg bid for 2 days with ropivacaine infusion administered 1 hour after ketoconazole) caused a 15% reduction in in-vivoo plasma clearance of ropivacaine. Pregnancy Category B: There are no adequate or well-controlled studies in pregnant women of the effects of Naropin on the developing fetus. Naropin should only be used during pregnancy if the benefits outweigh the risk. Labor and Delivery: Local anesthetics, including ropivacaine, rapidly cross the placenta, and when used for epidural block can cause varying degrees of maternal, fetal and neonatal toxicity (see CLINICAL PHARMACOLOGY and PHARMACOKINETICS). The incidence and degree of toxicity depend upon the procedure performed, the type and amount of drug used, and the technique of drug administration. Adverse reactions in the parturient, fetus and neonate involve alterations of the central nervous system, peripheral vascular tone and cardiac function. Maternal hypotension has resulted from regional anesthesia with Naropin for obstetrical pain relief. Local anesthetics produce vasodilation by blocking sympathetic nerves. Elevating the patient’s legs and positioning her on her left side will help prevent decreases in blood pressure. The fetal heart rate also should be monitored continuously, and electronic fetal monitoring is highly advisable. Epidural anesthesia has been reported to prolong the second stage of labor by removing the patient’s reflex urge to bear down or by interfering with motor function. Spontaneous vertex delivery occurred more frequently in patients receiving Naropin than in those receiving
more and more use of ultrasound techDr. Kileyy reported his group’s findnology for novel applications such as ings at the 2011 annual meeting of the this,” said Dr. Doyle, a member of the American Society of Anesthesiologists editorial board of Anesthesiology News. (abstract A791). —Michael Vlessides
bupivacaine. Nursing Mothers: Some local anesthetic drugs are excreted in human milk and caution should be exercised when they are administered to a nursing woman. The excretion of ropivacaine or its metabolites in human milk has not been studied. Based on the milk/plasma concentration ratio in rats, the estimated daily dose to a pup will be about 4% of the dose given to the mother. Assuming that the milk/plasma concentration in humans is of the same order, the total Naropin dose to which the baby is exposed by breast-feeding is far lower than by exposure in utero in pregnant women at term (see Precautions). Pediatric Use: The safety and efficacy of Naropin in pediatric patients have not been established. Geriatric Use: Of the 2,978 subjects that were administered Naropin Injection in 71 controlled and uncontrolled clinical studies, 803 patients (27%) were 65 years of age or older, which includes 127 patients (4%) 75 years of age and over. Naropin Injection was found to be safe and effective in the patients in these studies. Clinical data in one published article indicate that differences in various pharmacodynamic measures were observed with increasing age. In one study, the upper level of analgesia increased with age, the maximum decrease of mean arterial pressure (MAP) declined with age during the first hour after epidural administration, and the intensity of motor blockade increased with age. This drug and its metabolites are known to be excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Elderly patients are more likely to have decreased hepatic, renal, or cardiac function, as well as concomitant disease. Therefore, care should be taken in dose selection, starting at the low end of the dosage range, and it may be useful to monitor renal function. (See PHARMACOKINETICS, Elimination.) ADVERSE REACTIONS Reactions to ropivacaine are characteristic of those associated with other amidetype local anesthetics. A major cause of adverse reactions to this group of drugs may be associated with excessive plasma levels, which may be due to overdosage, unintentional intravascular injection or slow metabolic degradation. The reported adverse events are derived from clinical studies conducted in the U.S. and other countries. The reference drug was usually bupivacaine. The studies used a variety of premedications, sedatives, and surgical procedures of varying length. A total of 3,988 patients have been exposed to Naropin at concentrations up to 1.0% in clinical trials. Each patient was counted once for each type of adverse event. Incidence ≥5%: For the indications of epidural administration in surgery, cesarean section, postoperative pain management, peripheral nerve block, and local infiltration, the following treatment-emergent adverse events were reported with an incidence of ≥5% in all clinical studies (N=3988): hypotension (37.0%), nausea (24.8%), vomiting (11.6%), bradycardia (9.3%), fever (9.2%), pain (8.0%), postoperative complications (7.1%), anemia (6.1%), paresthesia (5.6%), headache (5.1%), pruritus (5.1%), and back pain (5.0%). Incidence 1-5%: Urinary retention, dizziness, rigors, hypertension, tachycardia, anxiety, oliguria, hypoesthesia, chest pain, hypokalemia, dyspnea, cramps, and urinary tract infection. Incidence in Controlled Clinical Trials: The reported adverse events are derived from controlled clinical studies with Naropin (concentrations ranged from 0.125% to 1.0% for Naropin and 0.25% to 0.75% for bupivacaine) in the U.S. and other countries involving 3,094 patients. Tables 3A and 3B list adverse events (number and percentage) that occurred in at least 1% of Naropin-treated patients in these studies. The majority of patients receiving concentrations higher than 5.0 mg/mL (0.5%) were treated with Naropin. Table 3A Adverse Events Reported in ≥1% of Adult Patients Receiving Regional or Local Anesthesia (Surgery, Labor, Cesarean Section, Post-Operative Pain Management, Peripheral Nerve Block and Local Infiltration)
Adverse Reaction Hypotension Nausea Vomiting Bradycardia Headache Paresthesia Back pain Pain Pruritus Fever Dizziness Rigors (Chills) Postoperative complications Hypoesthesia Urinary retention Progression of labor poor/failed Anxiety Breast disorder, breast-feeding Rhinitis
N 536 283 117 96 84 82 73 71 63 61 42 42 41 27 23 23 21 21 18
Naropin total N=1661 N 1661
(%) (32.3) (17.0) (7.0) (5.8) (5.1) (4.9) (4.4) (4.3) (3.8) (3.7) (2.5) (2.5) (2.5) (1.6) (1.4) (1.4) (1.3) (1.3) (1.1)
N 408 207 88 73 68 57 75 71 40 37 23 24 44 24 20 22 11 12 13
Bupivacaine total N=1433 N 1433
(%) (28.5) (14.4) (6.1) (5.1) (4.7) (4.0) (5.2) (5.0) (2.8) (2.6) (1.6) (1.7) (3.1) (1.7) (1.4) (1.5) (0.8) (0.8) (0.9)
Table 3B Adverse Events Reported in ≥1% of Fetuses or Neonates of Mothers Who Received Regional Anesthesia (Cesarean Section and Labor Studies)
Adverse Reaction Fetal bradycardia Neonatal jaundice Neonatal complication-NOS Apgar score low Neonatal respiratory disorder Neonatal tachypnea Neonatal fever Fetal tachycardia Fetal distress Neonatal infection Neonatal hypoglycemia
N 77 49 42 18 17 14 13 13 11 10 8
Naropin total N=1661 N 1661
(%) (12.1) (7.7) (6.6) (2.8) (2.7) (2.2) (2.0) (2.0) (1.7) (1.6) (1.3)
N 68 47 38 14 18 15 14 12 10 8 16
Bupivacaine total N=1433 N 1433
(%) (11.9) (8.2) (6.6) (2.4) (3.1) (2.6) (2.4) (2.1) (1.7) (1.4) (2.8)
OVERDOSAGE Acute emergencies from local anesthetics are generally related to high plasma levels encountered, or large doses administered, during therapeutic use of local anesthetics or to unintended subarachnoid or intravascular injection of local anesthetic solution. (See ADVERSE REACTIONS, WARNINGS, and PRECAUTIONS.) MANAGEMENT OF LOCAL ANESTHETIC EMERGENCIES: Therapy with Naropin should be discontinued at the first sign of toxicity. No specific information is available for the treatment of toxicity with Naropin; therefore, treatment should be symptomatic and supportive. The first consideration is prevention, best accomplished by incremental injection of Naropin, careful and constant monitoring of cardiovascular and respiratory vital signs and the patient’s state of consciousness after each local anesthetic and during continuous infusion. At the first sign of change in mental status, oxygen should be administered. The first step in the management of systemic toxic reactions, as well as underventilation or apnea due to unintentional subarachnoid injection of drug solution, consists of immediate attention to the establishment and maintenance of a patent airway and effective assisted or controlled ventilation with 100% oxygen with a delivery system capable of permitting immediate positive airway pressure by mask. Circulation should be assisted as necessary. This may prevent convulsions if they have not already occurred. If necessary, use drugs to control convulsions. Intravenous barbiturates, anticonvulsant agents, or muscle relaxants should only be administered by those familiar with their use. Immediately after the institution of these ventilatory measures, the adequacy of the circulation should be evaluated. Supportive treatment of circulatory depression may require administration of intravenous fluids, and, when appropriate, a vasopressor dictated by the clinical situation (such as ephedrine or epinephrine to enhance myocardial contractile force). Should cardiac arrest occur, prolonged resuscitative efforts may be required to improve the probability of a successful outcome. The mean dosages of ropivacaine producing seizures, after intravenous infusion in dogs, nonpregnant and pregnant sheep were 4.9, 6.1 and 5.9 mg/kg, respectively. These doses were associated with peak arterial total plasma concentrations of 11.4, 4.3 and 5.0 μg/mL, respectively. In human volunteers given intravenous Naropin, the mean (min-max) maximum tolerated total and free arterial plasma concentrations were 4.3 (3.4-5.3) and 0.6 (0.3-0.9) μg/mL respectively, at which time moderate CNS symptoms (muscle twitching) were noted. Clinical data from patients experiencing local anesthetic induced convulsions demonstrated rapid development of hypoxia, hypercarbia and acidosis within a minute of the onset of convulsions. These observations suggest that oxygen consumption and carbon dioxide production are greatly increased during local anesthetic convulsions and emphasize the importance of immediate and effective ventilation with oxygen, which may avoid cardiac arrest. If difficulty is encountered in the maintenance of a patent airway or if prolonged ventilatory support (assisted or controlled) is indicated, endotracheal intubation, employing drugs and techniques familiar to the clinician, may be indicated after initial administration of oxygen by mask. The supine position is dangerous in pregnant women at term because of aortocaval compression by the gravid uterus. Therefore, during treatment of systemic toxicity, maternal hypotension or fetal bradycardia following regional block, the parturient should be maintained in the left lateral decubitus position if possible, or manual displacement of the uterus off the great vessels should be accomplished. Resuscitation of obstetrical patients may take longer than resuscitation of nonpregnant patients and closed-chest cardiac compression may be ineffective. Rapid delivery of the fetus may improve the response to resuscitative efforts.
APP Pharmaceuticals, LLC
0173-NAR-05-4/11
Rev. 11/08
CORRECT
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“These findings suggest that correction of significant tricuspid regurgitation should be seriously considered in the setting of mitral valve surgery,” Dr. Swaminathan said. “However, it remains unknown whether the addition of a concurrent tricuspid valve procedure—thereby prolonging the bypass time—would decrease the long-term risk associated with that significant tricuspid regurgitation.” Dr. Swaminathan added that his group planned to look at patients with significant tricuspid regurgitation who underwent valve repair. “We’re going to see if there’s any modification of survival” in this group, he said. Roman M. Sniecinski, MD, associate professor of anesthesiology at Emory University School of Medicine in Atlanta, noted that previous studies demonstrated the association between the severity of tricuspid regurgitation and poor outcomes. “Dr. Heidenreich and colleagues from the San Francisco VA Medical Center published a study including more than 5,000 patients, which showed that moderate or severe tricuspid regurgitation was associated with increased mortality, independent of pulmonary arterial hypertension [[J Am Coll Cardioll 2004;43:405-409],” he told Anesthesiology News. “However, as Dr. Swaminathan points out, there are risks associated with an additional cardiac procedure, and it is unknown whether the benefits of correcting the tricuspid regurgitation outweigh them,” he said. “The benefits of tricuspid valve repair may be limited, since the right ventricle does not appear to be able to remodel itself as well as the left ventricle.” The researchers presented their findings at the 2011 annual meeting of the American Society of Anesthesiologists (abstract A786). —Michael Vlessides
AnesthesiologyNews.com I 11
AUGUST 2012
CL IN ICA L A N E STH E SIOL OG Y
Study Links Method of Anesthesia to In Vitro Success
A
dministering general anesthesia during in vitro fertilization may be associated with better outcomes for the procedure than conscious sedation, new research shows. Argentinean investigators retrospectively compared fertilization rates among nearly 450 patients who had undergone either general anesthesia or conscious sedation during oocyte retrieval and found significantly higher rates of fertilization and embryo development among those who received general anesthesia. But Robert Gaiser, MD, an expert in obstetric anesthesia who was not involved in the study, noted that there were no differences in pregnancy rates between general anesthesia and conscious sedation. “If, as I believe, there really are no differences between general anesthesia and conscious sedation in terms of pregnancy outcomes, then considerations such as cost, provider type and anesthesia availability may be the deciding factors that patients weigh in determining which form of anesthesia to opt for,” r professor of anesthesaid Dr. Gaiser, siology and critical care at the University of Pennsylvania Health Center, in Philadelphia. Gustavo Martinez, PhD, director of the Reproductive Biology Laboratory at the San Isidro Fertility Clinic, in Buenos Aires, who led the work, said there is uncertainty surrounding the potential effects of anesthesia on the success of in vitro fertilization. “There is research showing anesthetic drugs reach the ovary within minutes and can pass through the plasma membrane of the oocyte and accumulate inside,” explained Dr. Martinez, who presented the findings at the 2012 World Congress of Anesthesia (abstract 971). Dr. Martinez and colleagues retrospectively analyzed data from 438 women undergoing egg retrieval procedures. Of those, 105 received general anesthesia with midazolam and propofol and 333 received conscious sedation with midazolam and dextropropoxyphene along with either dipyrone or ibuprofen. Dr. Martinez said his team successfully fertilized 85% of oocytes retrieved among those who received general anesthesia, but were only able to fertilize 81% of oocytes retrieved in the conscious sedation group (P<0.05). Moreover, the researchers identified significant differences in embryo
Approximately 50% of development five days following fertilization. patients in both groups Specifically, 49% of sucachieved pregnancy and cessfully fertilized oocytes 44% in the two groups from women who received had successful deliveries. general anesthesia developed Dr. Martinez said the into embryos five days following results should be validated in fertilization, compared with 45% of fer- prospective studies. However, he said tilized oocytes taken from women who the study suggests “drugs used in conreceived conscious sedation (P<0.05). scious sedation may cause an adverse
effect that general anesthetics do not. Our hypothesis is that conscious sedation agents impair the accumulation of substances in the oocyte’s cytoplasm and therefore affect subsequent embryonic development. This effect seems not to exist, or to be lower, in the case of drugs used in general anesthesia.” —David Wild
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12 I AnesthesiologyNews.com
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T E C H NO L O G Y MAGELLAN
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Anesthesiology News. “Manually operated robotic nerve blocks are feasible and we are working on fully automating the Magellan system.” Dr. Hemmerling, associate professor of anesthesia at McGill University in Montreal, presented data on the Magellan at the 2012 annual meeting of the Society for Technology in Anesthesia (abstract 43). “This is absolutely fascinating,” said Keith Ruskin, MD, professor of anesthesiology and neurosurgery and director of the Division of Neuroanesthesia at Yale School of Medicine in New Haven, Conn., who was not involved in the research. “Ultimately, I think robotics will allow us to become systems managers, to pay attention to the big picture while mechanical tasks are done by machines.” The prototype Magellan, named for the 16thcenturyy Portuguese naval explorer, allows physicians to perform nerve blocks using a “joystick” that simulates the user’s arm and wrist movements and manipulates a robotic limb. The device also has a control panel that includes an Internet camera and ultrasound display. In a small prospective study, Dr. Hemmerling and colleagues used the Magellan to deliver nerve blocks following knee surgery in seven men and eight women. Three of the patients received bilateral blocks. The procedures were conducted in two phases, with clinicians first manually identifying the sciatic nerve and subsequently using the robotic arm to remotely insert the needle and inject bupivacaine. Dr. Hemmerlingg said the blocks were performed successfully with no complications. All of the patients experienced the same degree of pain control as would be expected with manual blocks, he added. Advertisement
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Figure. Robotic operation of the nerve block needle from the Magellan’s anesthesia cockpit. Inset: Overlapping areas between manual and automatic nerve detection.
The procedures required a median of three minutes (range, 90-305 seconds) to perform, with the robotic portion accounting for a median of 164 seconds (range, 73-271 seconds). Dr. Hemmerlingg said the procedures shortened over time as operators became familiar with the machine. As a step toward realizing their goal of fully automated nerve blocks, the investigators have developed an ultrasound-guided sciatic nerve-detection algorithm, which Dr. Hemmerlingg also presented at the meeting (abstract 44). The algorithm includes three steps: First, a computer examines an ultrasound image and reduces image noise; then it homes to the sciatic nerve by splitting the image into three clusters and isolating the third of the image with the brightest pixels; and finally, it eliminates imaged muscle fascia by excluding objects that are twice as wide as they are long. The largest remaining object, the algorithm assumes, is the sciatic nerve center. Dr. Hemmerlingg said a study that his team conducted showed the algorithm accurately identified the sciatic nerve in 95% of cases. In the trial, the algorithm was applied in 100 separate ultrasound images. Two anesthesiologists also were asked to identify the nerve centers on the same images. To optimize the algorithm’s accuracy, the researchers drew circles of various diameters around the algorithm-identified nerve center and calculated the percentage overlap of these circles with the physicianidentified nerve areas. The algorithm- and physicianidentified nerve centers overlapped 92% of the time when a 1-mm diameter circle was used, but only 63% of the time with a 1-cm diameter circle. Ultimately, Dr. Hemmerling’s team determined that the ideal diameter for at least a 98% overlap rate was 0.4 cm. “The automatic ultrasound nerve detection system proved to be reliable in detecting the sciatic nerve, and this system will pave the way for development of a completely automated robotic nerve block system,” Dr. Hemmerlingg emphasized in an interview with Anesthesiology News. “A larger study comparing the Magellan with manual nerve blocks is on its way.
‘Ultimately, I think robotics will allow us to become systems managers, to pay attention to the big picture while mechanical tasks are done by machines.’ —Keith Ruskin, MD “The goal is to allow physicians to conduct nerve blocks simply by placing an ultrasound probe onto the area of interest, identifying the nerve using the system’s-built in algorithm, and having the robot insert the needle automatically and injecting the local anesthetic,” he said. The researcher said that surgeons have benefited from the increased accuracy of robotically assisted endoscopic surgery compared with direct laparoscopic surgery, and that remote-controlled USguided robotics similarly may improve the accuracy of nerve blocks. “Nerve block needle insertion requires using one hand while the other hand operates the ultrasound probe for guidance,” Dr. Hemmerlingg said. “This can be challenging in terms of bimanual coordination and, consequently, movements of the needle can be abrupt or imprecise.” Dr. Ruskin said the main value of automating a nerve block—and of automation in anesthesia in general—would be to allow the anesthesiologist to manage unexpected problems. “Automation in the operation room frees up an anesthesiologist’s brain to perform tasks requiring higher-level functioning,” Dr. Ruskin said. “For example, one future application might be to automate pump infusion reprogramming so that in case a surgeon hits a blood vessel on the other side of the field, the anesthesiologist can assist with that while the infusion pump reprograms itself.” Dr. Hemmerlingg speculated that the Magellan may be available by 2017 and might cost approximately $100,000. His group also has developed the McSleepy robotic system for administering propofol and an automated intubation device called Kepler. —David Wild
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Continuous release keeps working Extended release delivers a near constant dose over 24 hours2 66% of Transderm Scop® patch patients vs. 46% for placebo reported no retching/vomiting within the 24-hour period postadministration
1. Ko otelko DM, Rottman RL, Wright WC, et al. Transdermal scopolamine decreases nausea and vomiting following cesarean section in patients receiving epidural morphine. Anesthesiology. 1989 9;71:675-678. 2. Transderm Scop® [package insert]. New Providence, NJ: Baxter Healthcare Corporation; 2006. Corp
Indications and Important Risk Information for the Transderm Scop® patch (scopolamine 1.5 mg) Transdermal Therapeutic System
Indications The Transderm Scop® patch is indicated in adults for prevention of nausea and vomiting associated with recovery from anesthesia and surgery. The patch should be applied only to skin in the postauricular area. Important Risk Information The Transderm Scop® patch is contraindicated in: Persons who are hypersensitive to the drug scopolamine or to other belladonna alkaloids or to any ingredient or component in the formulation or delivery system. Patients with angle-closure (narrow-angle) glaucoma. The Transderm Scop® patch should not be used in children. The Transderm Scop® patch should be used with caution in the elderly or in individuals with impaired liver or kidney function; patients with pyloric obstruction, urinary bladder neck obstruction, or in patients suspected of having intestinal obstruction. Also use with caution in patients with a history of seizures or psychosis.
Since drowsiness, disorientation and confusion may occur, patients should not drive, operate dangerous machinery, or participate in activities that require alertness. Patients should not use alcohol. Use with caution in patients taking other drugs that can cause CNS effects, such as sedatives or tranquilizers. Rarely, idiosyncratic reactions have occurred. The most serious that have been reported include acute toxic psychosis, confusion, agitation, rambling speech, hallucinations, paranoid behavior and delusions. Since scopolamine can cause dilation of pupils and blurred vision upon direct eye contact, patients should be strongly advised to wash hands thoroughly with soap and water immediately after handling the patch. Because of an aluminized layer in the delivery system, it is recommended to remove The Transderm Scop® patch prior to undergoing an MRI. Skin burns have been reported at the patch site during an MRI.
Monitor glaucoma therapy in patients with chronic open-angle (wide-angle) glaucoma.
In five postoperative nausea and vomiting clinical studies, the most commonly reported adverse events were dry mouth (29%) and dizziness (12%).
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PRN OB FELLOW
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University in Nashville, Tenn., called obstetrics a legitimate subspecialty of anesthesia with a wealth of skills. “A lot of people think it’s about time,” he said. “We’ve been due for this.” Some Pushing Required Not everyone agreed on the subspecialization. Some SOAP members were reluctant to push for accreditation, recalled John Sullivan, MD, MBA, who
directs the anesthesiology residency at Northwestern University, in Evanston, Ill., and who served as a member of SOAP’s Ad Hoc Committee on Accreditation. (Northwestern’s obstetric fellowship was among the ones to receive accreditation this spring.) “That school of thought believed that the additional administrative work, costs and lost flexibility would make seeking fellowship accreditation not worthwhile,” Dr. Sullivan told Anesthesiology News. Some existing
obstetric fellowships, for instance, are structured as a hybrid fellow/faculty position, which allows for higher pay and may be a recruitment advantage. That would not be allowed in an accredited fellowship. Maintaining accreditation also carries costs, and programs are already under financial pressure. These factors compound the fact that subspecialization within anesthesiology practices can, in itself, complicate call schedules and staffing as well
as rob generalists of valuable experience. “We watched the pediatric anesthesia community also wrestle with this,” Dr. Sullivan said. Prospective fellows, however, seem to value accredited fellowships, he added. “Would you like an oversight agency to ensure that the quality of your training is good? Of course. It’s a great thing for a resident. It creates a lot of work, though, for all of us.” Indeed, just applying for accredited status was a challenge. Having received the program requirements near the end of 2011, fellowship directors faced a tight Feb. 29, 2012, application deadline. Some directors said that they had to do far more description than overhaul. “I don’t think we are drastically changing the way we train our fellows” upon accreditation, Dr. Richardson said. However, he added, the new program—at least at Vanderbilt—will carry more rigorous provisions for assessment and feedback. New to some programs are two interdisciplinary requirements. Fellows must spend two weeks in a neonatal intensive care unit and two weeks with specialists in maternal and fetal medicine. Each one-year program also will include three months of protected research time. Number 5 Obstetric anesthesiology is the fifth subspecialty of anesthesiology to receive accreditation from the graduate education group, after cardiothoracic anesthesia, critical care anesthesia, pain medicine and pediatric anesthesia. The subspecialty has come into its own in part because of increased morbidity
AUGUST 2012
AnesthesiologyNews.com I 15
PR N anesthesia includes the management of chronic pain after cesarean surgery, the use of drugs like suboxone to aid in the management of opiatedependent mothers and any number of approaches to labor analgesia. In the long run, the next step for obstetric anesthesiology could be certification. Physicians training in three of the four accredited anesthesia subspecialties, as well as in hospice and palliative care, can seek certification from the American Board of Anesthesiology.
‘A lot of people think it’s about time. We’ve been due for this.’ —Michael G. Richardson, MD in pregnant patients compared with 20 years ago, said Michaela K. Farber, MD, fellowship director at the Brigham. “Women who wouldn’t have been well enough to reproduce, are now able to—and they still have a lot of risk,” Dr. Farber said. “So to have centers with people trained with the expertise required to have them safely deliver is increasingly important.” Advanced maternal age is one culprit: Older mothers have more comorbidities and are at higher risk for complications during delivery. Obesity and diabetes place many pregnant women in the high-riskk category; obesity as well as repeat cesarean deliveries also may be contributing to rising rates of postpartum hemorrhage. Many women also owe their chance at motherhood to advances in neonatal cardiac surgery. “Now most children born with congenital heart disease make it to adulthood and want to have children,” Dr. Hoyt said. “That’s a whole new body of medicine we weren’t even looking at 20 years ago.” Multiple pregnancies resulting from in vitro fertilization mean higher physiologic stress on the mother, which can unmask underlying comorbidities, said Mark Zakowski, MD, director of the fellowship at CedarsSinai Medical Center in Los Angeles, which received accreditation. Other knowledge central to obstetric
®
But no such option exists yet for obstetric anesthesiologists. “Whether we want to go down that pathway of an actual exam comes with a whole different set of questions and issues,” Dr. Hoyt noted. In the meantime, standardizing the curriculum will help both patients and obstetric anesthesiologists, she said. “Around the country, whether you’re on the East Coast or the West Coast or the center part of the country, you can be assured that people coming out of
accredited programs will have roughly the same body of knowledge,” she said. “I’m very excited about the whole thing.” Dr. Richardson, too, is enthusiastic about the development. “I think any profession that selff regulates needs to do it rigorously, and that’s what accreditation helps us to achieve,” he said. “It can only be good for our profession. It can only be good for patient care.” —Jenny Blair
16 I AnesthesiologyNews.com
AUGUST 2012
PRN FUJII
Twelve Years Later, a Hunch Proves Right
CONTINUED FROM PAGE 1
Investigators said they found no evidence of fraud in three of the papers, but could not determine whether the results reported in the remaining 37 were reliable. Of the 172 bogus studies, 126 involved randomized controlled trials. Investigators believe this was not a coincidence. “In order to be easily accepted by journals, he fabricated in most [of ] his papers that he studied large numbers of cases in a randomized controlled trial in double-blind manner,” the report stated. A consortium of 23 journals led by Steve Yentis, MD, editor-in-chieff of Anaesthesia, and Steven Shafer, MD, editor of Anesthesia & Analgesia ( (A&A ), earlier this year announced that it would retract any article of Dr. Fujii based on falsified data. Already, several journals have retracted articles by the researcher. The investigation concluded that Dr. Fujii’s co-authors, with at least one exception, were unaware of his misconduct. Indeed, it appears he forged their signatures in many, if not most instances. According to the investigation, “Both the number of animals and patients are totally different from the institutional records [for Dr. Fujii’s studies], although some of his early studies might have been done properly. As he stated in his interviewing that he enjoyed the communication with [journal editors] when submitting papers, he seemed to have justified all fabrications if papers were accepted.” Dr. Fujii employed deliberate ambiguity in his manuscripts to avoid detection, the report said. “The name of the institution and the period of the study have not been specified in his papers so that he could [use the] excuse that ‘the data were obtained at a previously worked hospital or in a place where he took a part-time job.’ The institutions of the research ethical committees also have not been specified. Additionally, he made papers [seem] as if they Advertisement
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eter Kranke, MD, has every right to feel smug, even if what he really feels is a sense of relief. After all, Dr. Kranke, of University Hospital of Würzburg, in Germany, was the leader of a group of researchers who in 2000 publicly questioned the statistical plausibility of the results that Yoshitaka Fujii, MD, had been reporting in his studies of the antiemetic granisetron. At the time, that warning went virtually unheeded—at least outside a small group of journal editors in the anesthesia community who shared the suspicions but were powerless to stop Dr. Fujii from publishing in other journals. A dozen years later, Dr. Kranke and his colleagues have been proven right. “The interesting thing for me is that it is now in every mouth, but at that stage nobody seemed to be interested in this story,” Dr. Kranke told Anesthesiology News. Part of that undoubtedly reflects the astonishing scope of the deception: If the consortium of journals keeps its promise to retract all of Dr. Fujii’s tainted studies, at least 172 papers, and possibly more, will
P
were multihospital studies, by placing the names of other institutions as his co-authors. He has used these methods effectively to escape from doubts of fabrications.” And he took steps to minimize the involvement of his co-authors with the journals, including forging their names on attestations of authorship: “Although journals recently require signatures of all authors, Dr. Fujii stated that he submitted his papers without co-authors’ signatures, because he had not been required [to do] so by [editors]. The JSA Investigation Committee has obtained a cover letter signed by two authors other than Dr. Fujii. These two signatures have been proven to be fabricated.” The investigators do identify one co-author, r Hidenori Toyooka, who appears to have known about the fabrication and yet still co-authored “dozens” of papers with Dr. Fujii. According to the report, Dr. Toyookaa “recognized the suspicion” raised against his colleague in 2000, but “did not take any action.” The report also suggests that Dr. Fujii’s co-authors were largely oblivious to their association with the discredited researcher: “Some used these papers as their achievements and others did not even know the papers were published with their names. Actually, many of Dr. Fujii’s papers were submitted without co-authors’ approval and they did not receive reprints of accepted papers. Accordingly, they did not notice that the papers existed.” The news, first reported by the Japanese press, comes more than 12 years after researchers first publicly questioned the validity of Dr. Fujii’s research. In 2000, a trio A challenged the Japof anesthesiologists writing in A&A anese scientist’s data as being “incredibly nice”—not a compliment. In particular, the authors noted troubling statistical anomalies in the rates of side effects Dr. Fujii reported in his studies of antiemetics. Although Dr. Fujii responded with his own letter, according to Dr. Shafer the scientist began submitting most of his papers to journals outside the anesthesiology literature—titles in head and neck surgery, ophthalmology and other specialties.
fall—the most by any single researcher to date. But Dr. Kranke said the mindset of academic medicine, and anesthesiology in particularly, has shifted since the early 2000s, thanks in large part to the revelations about two other notorious colleagues, Scott Reuben, MD, and Joachim Boldt, MD, PhD. Back then, he said, the notion of data fabrication, studies without ethics approval and other deception “was far, far away in the anesthesia community. We did not have any experience with fraud, and if you raised suspicions then—or if you just mentioned some suspicion—everybody looked at you as if you came from another star. Now it’s thinkable that fabrication occurs in anesthesia.” While Dr. Kranke is glad that the research and clinical communities now know that they cannot trust Dr. Fujii’s results, that’s not because he wants to see the scientist disgraced. “For me it is not an issue that somebody gets punishment,” he said. “But we should try to prevent people from making a wrong decision based on wrong data.” —A.M.
About two years ago, the wheels began to turn more vigorously. Dr. Yentis, who had been concerned about the impact in the field of Dr. Fujii’s flawed research, convened a group of editors to discuss how to handle the papers. In 2010, he asked a British anesthesiologist, John Carlisle, to conduct a thorough statistical analysis of Dr. Fujii’s studies. Then, in 2011, Dr. Fujii made a misstep. He submitted a manuscript to the Canadian Journal of Anesthesia, edited by Donald Miller, MD, on an aspect of canine physiology. In the course of reviewing the paper, Dr. Miller realized that the article contained plagiarism. He confronted Dr. Fujii, who asked to withdraw the manuscript. Dr. Miller demurred, and with the help of Drs. Yentis and Shafer—whose journal published 24 of Dr. Fujii’s papers—brought the matter to the attention of officials at Toho University. What followed was at times a frustrating backk andforth between the editors—who saw an opportunity finally to expose Dr. Fujii and clean the literature— and the university, whose officials appeared to want to limit the public damage. When Toho University and other institutions at which Dr. Fujii had worked finally released their report earlier this year, they acknowledged that Dr. Fujii had failed to obtain proper ethics committee approvals to conduct at least eight studies. But, to the chagrin of the editors, they remained silent on the question of whether his results could be believed. Meanwhile, the journal Anaesthesia, took matters into its own hands. In March, the journal published Dr. Carlisle’s analysis of 169 of Dr. Fujii’s papers. The study found that the odds of the data being generated experimentally—as opposed to by fraud—were implausibly small, on the order of 1 in 10(30). Deadline Ignored In April, the consortium of editors issued an ultimatum to Dr. Fujii’s former institutions: vet his findings by June 30, the date when the journals would act to retract the articles they believed to be rooted in fraud. see Fujii page 45
Available online @ AnesthesiologyNews.com
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abeo . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18 Anesthesia Business Consultants. . . . . . . . . . . . . . . . 20 Arizant Healthcare Inc., a 3M Company . . . . . . . 22 B. Braun . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23 Edwards Lifesciences . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24 GE Healthcare . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26 McMahon Publishing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27 KARL STORZ Endoscopy-America, Inc. . . . . . . . . 28
LMA North America . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30 MAQUET Medical Systems USA . . . . . . . . . . . . . . . . . . . 32 Masimo. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34 Nonin Medical, Inc. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36 Sheridan Healthcare, Inc. . . . . . . . . . . . . . . . . . . . . . . . . . . 38 Spacelabs Healthcare . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40 Verathon Medical . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
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ABEO
a
beo has made a name for itself in the anesthesia industry as the leading provider of anesthesia billing and practice management services. Since its formation in 2007, abeo has worked diligently to establish a reputation for outstanding service and high-performance results. abeo differs from its discount-driven competitors that focus on price as the determing factor in selecting a billing and practice management company. abeo’s approach consists of three key philosophies: • We do more. abeo’s culture and operational structure is client-centric. The company looks for opportunities in all areas to provide better service and results to its clients. Going above and beyond expectations is what abeo strives for daily. • We get the job done right. Patients are not left in the operating room because you “didn’t finish before it was time to go home” or “it was just too difficult to finish.” It simply isn’t an option for your team to not finish a job. You can expect the same from abeo. abeo finishes the job and gets it done right. • You get what you pay for. As much as we hate to sound cliché, there really is no better way to say it. Billing is not a commodity; quality, service and expertise matter when it concerns your bottom line. abeo stands by its approach because it yields better results for clients. abeo’s staff understands their clients work hard and have high expectations: In today’s market, bottom-line performance alone is not sufficient. One must be prepared for the future and an ever-changing health care industry. abeo recently expanded its service offerings in hospital integration and ambulatory surgery center billing. Expanding on its knowledge base and structure in these areas positions abeo to continue serving the needs of anesthesia providers today and moving into the future.
Revenue Cycle Management Billing today takes on a whole new meaning. abeo’s team keeps pace with the rapidly transforming industry so its clients have less to worry about. abeo’s core business is the management of the entire revenue cycle. In addition to the standard billing and reimbursement services one would expect with any company, abeo differentiates itself in the following areas: • Compliance oversight. In addition to its basic compliance program, abeo conducts internal audits and annual coding documentation training. • Managed care contract enforcement. abeo does more than negotiate and administer contracts. It goes the extra mile to ensure that payers adhere to the elements of the contract.
• Credentialing. As credentialing becomes more complex, abeo has put more resources into ensuring that trained professionals are handling the physician and facility credentials. • Collections/Follow-up. Each account is touched at least once a month. This approach helps increase cash flow and greatly reduces the amount of bad debt. • Outstanding balances. Most billing companies do not have dedicated resources or expertise to pursue outstanding balances. abeo’s self-pay follow up policy includes live phone calls to work on a payment plan with your patient. We understand this process reflects on the client’s practice. We conduct calls respectively and during patient’s most convenient and local time zone hours.
Anesthesia Business Support Real knowledge, like everything else of value, is not obtained easily. abeo has assembled a business services team that has the wherewithal to collaboratively develop solutions for clients. They provide a full spectrum of proficient business services to meet the needs of anesthesia providers from beginning to end of the revenue cycle. Some of the most sought-after services include the following: • Contracting negotiation and services. abeo’s contracting managers have strong relationships with all major payers. Their effective strategies to maximize contracted rates of reimbursement make a big impression with clients. Their expertise also assists with progressing clients’ relationships with various facilities to maximize compensation contracts. • Strategic management and planning. abeo can improve overall practice procedures by evaluating potential merger and acquisition expansion opportunities and analyzing billing and scheduling data. • Anesthesia data analytics. Clients can enhance their decision making with abeo’s custom reporting packages that illustrate operational performance by site/case/volume and so on. abeo produces quality data that leads to solutions for its clients’ practices. • Compensation and financial management. abeo develops and designs compensation models to distribute income across physician groups. abeo also manages clients’ financial accounts, including all client group expenses, payroll compensation reports, budget development and execution. • Benefit procurement. abeo designs and implements practice benefits such as health and liability insurance, retirement, disability insurance and flexible spending and cafeteria plans.
AT A GLANCE ABEO MANAGEMENT CORPORATION A privately held company providing the most comprehensive billing and business services available to anesthesia providers and ambulatory surgery centers nationwide.
PRODUCTS MedSuite Billing & Management Software, abeoCoder App, abeoChart App, abeoDirect App, abeoLink
SERVICES Billing, coding, follow-up/collections, compliance, compensation models, revenue cycle management, transcription, business assessments, contracting services, consulting, financial management, practice management, business intelligence, advanced reporting and more.
EMPLOYEES 1,000+
CONTACT INFORMATION Phone: (888) 281-6187 Email: info@abeo.com Web site: abeo.com LinkedIn: company/abeo Facebook: /abeoManagement Twitter: @abeoManagement
Look No Further Whether a client’s practice needs a comprehensive solution to the complete revenue cycle process or requires services provided a la carte, abeo will structure its services to meet those needs. Contact abeo for an anesthesia business assessment to understand how well your practice is performing. abeo leverages its data, knowledge and expertise that comes from working millions of transactions annually to create an objective billing and documentation assessment. A clear understanding of how your anesthesia practice performs in comparison to others nationwide is essential to making informed business decisions that affect your current and future success.
18 Anesthesiology News • August 2012
This corporate profile was reviewed and approved by abeo.
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ANESTHESIA BUSINESS CONSULTANTS
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AT A GLANCE
nesthesia Business Consultants, LLC (ABC) is the largest billing and practice management company dedicated to the complex and intricate specialty of anesthesia and pain management. It is both an American Society of Anesthesiologists Practice Management Supporter and an Anesthesia Quality Institute Preferred Vendor. Tony Mira, ABC’s founder, president and CEO, has maintained a concentration on providing services exclusively to anesthesia and pain management professionals since the company’s inception more than 30 years ago. ABC distinguishes itself by providing optimal business tools to strengthen business processes and enhance cash flow—all while keeping pace with constant changes in the health care environment. ABC prides itself on the longevity of its client relationships and its ability to customize services to the unique requirements of each practice. ABC offers its clients innovative billing and reimbursement services, as well as valuable practice management tools and solutions that allow them to realize their own particular strategic visions and business plans.
• • • •
Payment Processing Collection Reporting Compliance
The ABC Management Advantage
The ABC Technology Advantage
ABC distinguishes itself through its focus, operational approach and management structure: • Unlike many competitors who continually redefine their market focus, ABC has remained true to its core market of anesthesiologists, certified registered nurse anesthetists and pain management specialists, enhancing the credibility of its insight and advice. • ABC believes its relationship with its clients is a true partnership, not just a client–vendor relationship. A partnership in which ABC not only helps improve the billing process, but also helps the group operate more efficiently in the operating room, and more proactively in its relationship with the hospital. • ABC’s centralized approach allows effective management and oversight, ensuring consistent results. • Managing a business based on the input and expectations of shareholders does not always result in the most appropriate business decision making. Because ABC is privately held, it has much greater flexibility in setting its agenda, managing the business and being responsive to its clients’ needs.
In order to ensure flexibility with its clients and their varying level of needs, ABC has carefully crafted a portfolio of products to meet its clients’ needs during the entire perioperative process.
ADDRESS
Management Support Services No one company is more qualified to furnish critical management information and proactively advise practice decision makers. Although many management companies have isolated areas of strength and specific competence, ABC stands alone in its ability to provide a full range of management support services: • Strategic Management • Practice Management - Practice Consulting - Financial Services - Quality Management (PQRS) - Human Resources Consulting - Contracting Services - Compliance and HIPAA - Education and Training
Leading-Edge Technologies
ABC has created and maintains the most advanced, secure and reliable software designed especially for anesthesia billing and practice management, F1RSTAnesthesia™. This powerful tool converts clinical information into claims for reimbursement. It supports electronic claims editing to ensure consistently high billing acceptance rates and minimizes manual intervention in payment posting through direct remittance processing. Providers also are able to receive real-time or historical information through F1RSTAnesthesia T ’s Web-based technology or advanced data warehousing/data-mining technology. ABC is committed to continually updating the F1RSTAnesthesia T ™ software to adapt to meet the changing needs of its clients. Its accomplished in-house technology staff continually works to improve this powerful The ABC Service Advantage software. Updates to this family of products include: ABC offers a full range of services designed to meet • F1RSTAccess T , a mobile Web application that allows its clients’ needs, from a specific area of service to an clients to view the reports on their Apple iPhone all-encompassing solution partner. 3G/4G or iPad device. • F1RSTTouch tracks and Billing and Reimbursement Services reports charge informaBecause all processing is performed in a central tion and provides cuslocation, ABC maintains a high standard for quality tomers with the ability to control and efficiency, resulting in faster claims resoquickly collect and report lution and higher levels of reimbursement. Extensive clinical workflow or metric management reporting options allow both manageinformation. ment and client to monitor subtle changes in payer • F1RSTPay allows patients to mix and reimbursement patterns. Services include: make payments directly to • Patient Charge Collection ABC through devices such Tony Mira, President and • Charge Coding, Entry and Claims Scrubbing as the Apple iPhone or iPad. Chief Executive Officer
Anesthesiology News • August 2012
255 West Michigan Ave. Jackson, MI 49201 Phone: (800) 242-1131 Fax: (517) 787-0529 Web sites: www.anesthesiallc.com www.communiquenews.com http://twitter.com/AnesthesiaLLC https://www.facebook.com/anesthesiallc
SERVICES Full-service billing and practice management firm dedicated exclusively to anesthesiologists and pain management physicians.
EMPLOYEES 850+
Clinical Technologies ABC recognizes that in order for its clients to remain essential partners with the facilities they serve, they must be proactive in their approach to the ever-increasing need and requirement to adopt clinical technologies. Keeping abreast of the latest technological advancements can be a difficult task for a practice to undertake. ABC’s strategic partnerships with key software providers have enabled it to produce the OneSourceAnesthesia platform. OneSourceAnesthesia offers an à la carte approach to the complete perioperative process—clients choose the features they need now, and have the peace of mind that comes from knowing OneSourceAnesthesia e is adaptable and that they can add increasing functionality as their needs grow and change. ABC customers can leverage the full feature set of OneSourceAnesthesia e including: • Patient Portal • Preadmission tracking (PAT) • Preoperative Lab Recommendations and Medical Clearances • Preoperative Holding Documentation • Electronic Charge Capture • Anesthesia Information Management System • Postoperative Quality Collection • Full integration to ABC’s F1RSTAnesthesia T • Automatic upload to Anesthesia Quality Institute (AQI) • Anesthesia Call Scheduling and Management The primary hardware tool required for ABC’s solution is an Apple iPad. The OneSourceAnesthesia solution also requires no interaction with the hospital or surgery center’s servers to host the software in any way. These elements, when combined with the intuitive user experience of OneSourceAnesthesia, offer an unparalleled platform to streamline and automatically incorporate best practices and clinical protocols to any practice.
This corporate profile was reviewed and approved by Anesthesia Business Consultants.
Tie Value with Technology Bringing a New Value Proposition to Your Practice Anesthesia Business Consultants is proud to announce the latest update to our fully-integrated perioperative solution, OneSourceAnesthesia. ABC’s OneSourceAnesthesia is now integrated with iMDsoft’s iMV Mobile EMR Solution. OneSourceAnesthesia offers the a la carte approach to the complete perioperative process—choose the features you need now, and have the peace-of-mind that comes from knowing OneSourceAnesthesia is adaptable and that you can add increasing functionality as your needs grow and change.
No Servers, No Additional Integrating with Hospital or Surgery IT Departments, No Problem! The iMV Mobile EMR product is a co-development effort between ABC and iMDsoft focusing on the mobile needs and documentation requirements of our anesthesia providers. It is critical to have a technology that is easy to use, but also robust, without impacting the facility. Our solution is the only one to provide: t Complete offline capabilities t No hardware or software requirements from the hospital or surgery center t Dynamic and specialized rules to meet anesthesia documentation requirements t Automatic interfacing to ABC The primary hardware tool required for our solution is an Apple iPad. Additionally, the OneSourceAnesthesia solution requires no interaction with the hospital or surgery center’s servers to host the software in any way. These elements, when combined with the intuitive user experience of
unparalleled platform to streamline and automatically incorporate best practices and clinical protocols to any practice. OneSourceAnesthesia, offer an
800.242.1131 info@anesthesiallc.com www.anesthesiallc.com
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ARIZANT HEALTHCARE INC., A 3M COMPANY 25 Years: Amazing Every Day
T
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AT A GLANCE
he term “amazing” gets tossed around quite a bit these days, and is too often used to describe products that ultimately deliver far less than advertised. But when 3M™ Bair Hugger™ therapy was introduced in 1987, it truly was (and continues to be) an amazing advancement in health care. It changed the way surgery was done. This ingeniously simple product makes it easier for clinicians to do their jobs. It helps improve the quality of care by safely, effectively maintaining normothermia and reducing the complications associated with inadvertent perioperative hypothermia. And that’s something we can all feel good about. This year marks Bair Hugger therapy’s 25th anniversary, and we couldn’t be more proud to offer a full range of patient warming solutions that set the standard for innovation and quality: 3M Bair Hugger therapy, 3M™ Bair Paws™ patient adjustable warming gowns and 3M™ Ranger™ fluid warming systems. Arizant Healthcare’s surgical warming products are used to maintain normothermia for more than 20 million patients each year. We look forward to partnering with you on the mission to improve patient outcomes through effective patient warming.
clinicians full patient access. The full-access underbody blanket is showing rapid acceptance by the trauma community with its ability to be pre-set in the trauma bay and then warm the patient from admission and assessment to computed tomography and into the OR or ICU. The underbody series was developed by working directly with clinicians to ensure the designs meet a wide range of warming demands including cardiothoracic, cosmetic, gynecologic, urologic, orthopedic, pediatric, reconstructive, transplant, trauma, vascular and other major surgical procedures.
3M™ Bair Hugger™ Therapy (www.bairhugger.com)
Bair Paws flex gown
Bair Hugger therapy was the first forced-air warming product line, and today it remains the market leader. Forced-air warming therapy is a simple, safe and cost-effective method to prevent unintended hypothermia and its Bair Hugger therapy fullaccess underbody blanket associated complications, which include an increased rate of wound infection,1 increased hospital length of stay2 and higher mortality rates.3 Maintaining perioperative normothermia has been cited by quality improvement initiatives around the world as a key factor in reducing the rate of surgical site infections. Many of these same initiatives, including the Centers for Medicare & Medicaid Services’ new normothermia quality measure, include forced-air warming in their definition of active warming. Bair Hugger warming units are used in more than 80% of U.S. hospitals, and more than 160 million patients have experienced the benefits of Bair Hugger therapy. Our ongoing commitment to innovation and patient warming has resulted in a product lineup of 25 single-use Bair Hugger warming blanket models, including five adult and two pediatric underbody series blankets. The Bair Hugger therapy underbody series warms from underneath the patient, addressing a clinical need to prevent unintended hypothermia while providing
The Bair Paws flex gown combines the best of both worlds: the comfort and convenience of the Bair Paws gown with the powerful, proven warming of Bair Hugger upper- and lower-body blankets. With the Bair Paws flex gown, patients arrive in the OR already warm when prewarmed before surgery. The same gown enables upper- or lower-body warming in the OR thanks to effective warming tools built right into the gown. Separate upper and lower inserts allow you to activate warming where you want it, with the upper warming insert including all the features of a Bair Hugger upper body blanket. When the patient is ready for the PACU, simply perforate off the upper body warming “sleeves,” head drape and adhesive strip to provide maximum postoperative comfort while maintaining comfort and clinical warming capabilities. The tools that helped the patient in the OR are now conveniently out of the way. The gown’s flexibility eliminates the costs and hassles of buying, storing and using multiple items like cotton gowns and blankets, and various OR warming products while improving patient satisfaction by keeping patients warm, cozy and covered. This all-in-one warming capability makes the Bair Paws flex gown a great option for achieving normothermia-related quality measures.
Anesthesiology News • August 2012
3M™ Bair Paws™ Flex Gown (www.bairpaws.com)
ADDRESS 10393 West 70th St. Eden Prairie, MN 55344 Phone: (800) 733-7775 Web site: www.arizanthealthcare.com
PRODUCTS 3M™ Bair Hugger™ therapy; 3M™ Bair Paws™ patient adjustable warming system; 3M™ Ranger™ blood and fluid warming systems.
WORLDWIDE EMPLOYEES 314
VICE PRESIDENT, PATIENT WARMING Bob Buehler
3M™ Ranger™ Blood and Fluid Warming Systems (www.rangerfluidwarming.com) A complete protocol for perioperative temperature management should include both forced-air warming and the warming of infused blood and fluids to help maintain a patient’s core body temperature.
Ranger blood and fluid warming systems feature highly conductive heating plates that disperse heat immediately, handling sudden changes in flow with Ranger irrigation warming unit ease. Dry heat technology disperses heat evenly, eliminating dangerous hot spots and overheating of fluids by monitoring the temperature four times every second, automatically adjusting to maintain a consistent set point. And because the system utilizes dry heat technology rather than the water-based method, concerns regarding water in the operating room—and its potential ties to nosocomial pathogens—are eliminated. The latest introduction to the Ranger product lineup, the Ranger irrigation fluid warming system is an intuitive, easy-to-use solution for high-volume surgical irrigation. The Ranger irrigation system quickly adapts to flow rates of zero to 865 mL per minute. The system’s disposable sets feature a patient line contained within its own sterile packaging, and each latex-free, disposable set is designed for use during surgical procedures and/or postoperative irrigation. 3M is a trademark of 3M Company, used under license in Canada. BAIR HUGGER, BAIR PAWS and RANGER and the BAIR HUGGER, BAIR PAWS and RANGER logos are trademarks of Arizant Healthcare Inc., used under license in Canada. 1. Barie PS. Surgical site infections: epidemiology and prevention. Surg Infect (Larchmt). 2002;3[supp]:S9-S21. 2. Jeran L. American Society of PeriAnesthesia Nurses Development Panel. Clinical guideline for the prevention of unplanned perioperative hypothermia. J Perianesth. Nurs. 2001;16:305-314. 3. Tryba M, Leban J. Does active warming of severely injured trauma patients influence perioperative morbidity? Anesthesiology. 1996;85:A283.
This corporate profile was reviewed and approved by Arizant Healthcare Inc., a 3M Company.
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B. BRAUN
B.
Braun, a trusted leader in regional anesthesia and ambulatory infusion systems, uses cutting-edge technology to help anesthesiologists and nurses improve patient outcomes, both in surgery and during recovery. Founded in 1839, B. Braun is committed to advancing the safety and efficacy of medical technology across markets from infusion therapy to pharmacy admixture and drug delivery to regional anesthesia. An organization with more than 43,000 professionals worldwide, B. Braun meets customer needs by providing products with unmatched quality, cost-effectiveness, environmental responsibility, superior technology and safety. Using its Sharing Expertise® initiative as a driving philosophy, B. Braun collaborates with customers, partners and employees to develop innovative products, services and education programs—and continues to lead the way in anesthesia.
Innovative Peripheral Nerve Block Products for Ultrasound-Only and Dual Guidance Whether using only ultrasound, nerve stimulation or both ultrasound and nerve stimulation (dual guidance) to guide peripheral nerve block (PNB) placement, B. Braun Medical Inc. (B. Braun) has products designed with your technique in mind. Answering the need for simple, cost-effective ultrasound-guided continuous PNB, B. Braun has created the Contiplex® FX system. The latest generation of B. Braun PNB products is intended specifically to support providers who no longer use a dual guidance or stimulation approach, as well as blocks that can be performed without the aid of stimulation. Among the key features of the B. Braun Contiplex FX system is the unique echogenic springwound catheter designed to help easily confirm catheter placement with ultrasound. Designed with functionality in mind, Contiplex FX combines a rigid catheter body for easy handling and a softer-than-standard tip that helps to maintain the catheter tip in the optimal fascial plane during ultrasound-guided placement. Like other B. Braun continuous PNB products, Contiplex FX is designed with a patented sideport valve that saves steps by allowing the catheter to be preloaded into the needle hub while still allowing aspiration, injection and hydro-dissection through the needle. Contiplex FX is available in both open and closed tip configurations.
Staying ahead of the innovation curve in regional anesthesia, B. Braun will continue its leadership with the launch of Ultraline. With ultrasound practitioners in mind, this complete line of PNB products is specially designed for PNBs at steep angles where needle visualization may be more challenging. Its ease of use may also bring value in helping those just beginning to master ultrasound-guided procedures. Ultraline features markings on the needle designed to enhance ultrasound visualization and will be offered in three configurations: Stimuplex® Ultra, a stimulating single-shot needle; Ultraplex, a non-stimulating singleshot needle; and Contiplex Tuohy Ultra, a stimulating needle for placing catheters under ultrasound. For more information on Ultraline needle markings and applications, please visit www.stimuplexultra.com.
AT A GLANCE ADDRESS 824 Twelfth Ave. Bethlehem, PA 18018 Phone: (800) 227-2862 Web site: www.bbraunusa.com
PRODUCTS Pain control products; disposable post-op pain pumps; IV solutions in latex-, PVC- and DEHP-free bags; needle-free systems; electronic pump delivery systems
CEO, CHAIRMAN OF THE BOARD Caroll H. Neubauer
Epidural, Spinal and CSE Portfolio B. Braun’s market-leading Perifix® epidural line is enhanced by the Perifix® FX Springwound Epidural Catheter. Designed to reduce paresthesia and vessel puncture rates, the FX is available in open-tip uniport and closed-tip multiport versions. For more information on the Perifix FX, please visit www.perifixfx.bbraunusa. com/AN. B. Braun’s Pencan® Pencil Point spinal needle is designed for high flow rates for rapid detection of cerebrospinal fluid.
B. Braun’s complete Regional Anesthesia portfolio also features a patented CSE (Combined Spinal Epidural) product line. The Espocan® Docking System enables anesthesia providers to lock the position of the spinal needle during combined-technique procedures. The small, unobtrusive docking system sleeve helps inhibit forward and backward movements of the spinal needle while still permitting needle rotation.
Disposable Post-Op Pain Pumps B. Braun is the exclusive US distributor of the new Symbios® GOBlock® post-op pain pumps for continuous PNB. The GOBlock portfolio features both fixed and selectable flow rate pumps. GOBlock components do not contain natural rubber latex or DEHP. B. Braun’s outsourcing pharmacy affiliate, CAPS®, can pre-fill GOBlock with Ropivacaine and Bupivacaine in all 24 CAPS
This corporate profile was reviewed and approved by B. Braun.
locations nationwide. CAPS can label pre-filled GOBlock pumps with extended beyond-use dating, and ensure the stability and sterility of pre-filled GOBlocks through enhanced process and quality controls. Visit www.painpumpadvantage.com and www.capspharmacy. com for more product and service details.
Syringe Pump Infusion System B. Braun’s Perfusor® Space Syringe Pump uses advanced delivery features to offer safety and accuracy for syringe pumps. Easy to learn and use, the system includes built-in error reduction software and an onboard medication library accommodating both hard and soft limits. Navigation is made simple with large navigational arrows and a screen that remains legible in any light condition. Measuring just nine by six inches and weighing only three pounds, the compact and lightweight design of the Perfusor Space Syringe Pump allows easy transport and flexibility in crowded care settings. The system is perfect for operating rooms, adult care units and pediatric settings, where ease of use and precise medication administration are of critical importance.
Anesthesiology News • August 2012
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2012-2013
Corporate Profiles
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EDWARDS LIFESCIENCES
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dwards Lifesciences’ hemodynamic monitoring and management systems provide tailored hemodynamic optimization and clarity for patient status, enabling clinicians to make even more informed and rapid decisions when a patient’s hemodynamic balance becomes disrupted. Edwards’ extensive line of hemodynamic monitoring catheters, sensors and bedside patient monitoring tools support your monitoring needs in the OR and ICU. The goal of these systems is to provide the clarity clinicians need, in those unknown moments, when caring for and treating patients in high-risk surgery. Edwards’ extensive line of tools includes: • EV1000 clinical platform presents the physiologic status of the patient in an entirely new, intuitive and meaningful way. Designed to work with the FloTrac sensor and PreSep oximetry catheter, the platform offers the scalability and adaptability for both the OR and ICU. • The FloTrac sensor is the first minimally invasive hemodynamic monitoring device that connects to any existing arterial line and continuously calculates key flow parameters such as cardiac output, stroke volume and stroke volume variation. One million patients worldwide have been monitored using the FloTrac sensor.
• Edwards also offers the PreSep oximetry catheter, which continuously measures a patient’s central venous oxygen saturation, providing an earlier and more global view of tissue oxygenation. • Advanced technology versions of the Swan-Ganz catheter provide a single, continuous monitoring solution for the most complex patients. • Edwards is a global leader in the broader field of pressure-monitoring devices with the TruWave pressure transducer. This can be combined with the VAMP (Venous Arterial blood Management Protection) closed-loop blood sampling system to protect both patients and clinicians from the risk for infection. • Edwards offers an extensive line of education and support tools to facilitate the integration of advanced hemodynamic monitoring and management in highrisk surgery. www.Edwards.com/CCeducation features perioperative patient simulations, simulated case studies, product animations and more. Edwards recognizes that assessing a patient’s hemodynamic and oxygenation status and minimizing the risk for infection are fundamental requirements for high-risk surgery and treating critically ill patients. Edwards will continue to leverage its experience and leadership in this area to help clinicians advance patient care.
AT A GLANCE ADDRESS One Edwards Way Irvine, CA 92614 Phone: (800) 424-3278 (949) 250-2500 Email: CriticalCare@Edwards.com Web site: www.Edwards.com/ CriticalCare
PRODUCTS Hemodynamic monitoring systems including the FloTrac sensor; PreSep oximetry catheter; Swan-Ganz pulmonary artery catheter; TruWave pressure transducer; VAMP (Venous Arterial blood Management Protection) system; and EV1000 clinical platform.
CAUTION: Federal (United States) law restricts this device to sale by or on the order of a physician. See instructions for use for full prescribing information, including indications, contraindications, warnings, precautions and adverse events.
The EV1000 clinical platform provides a variety of informative screens from which to choose to provide immediate insight and guide your therapeutic interventions. The platform also allows you to select the parameters most significant for your monitoring requirements, enabling you to make more informed decisions and determine the best course of action.
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Edwards Lifesciences, the stylized E logo, EV1000, FloTrac, PreSep, Swan-Ganz, TruWave and VAMP are trademarks of Edwards Lifesciences Corporation.
Anesthesiology News • August 2012
This corporate profile was reviewed and approved by Edwards Lifesciences.
Optimize your high-risk surgical patients’ fluid balance. The FloTrac system enables an individualized approach for delivering and tailoring fluid therapy the for perioperative pe hemodynamic optimization. The FloTrac sensor has been used on over 1 million patients nts worldwide – more than any other fluid management solution. Visit Edwards.com/FloTrac to experience advanced therapy navigation.
CAUTION: Federal (United States) law restricts this device to sale by or on the order of a physician. See instructions ti for use for full prescribing information, including indications, contraindications, warnings, precautions, and adverse events. e Edwards, Edwards Lifesciences, the stylized E logo, and FloTrac are trademarks of Edwards Lifesciences Corporation. © 2012 Edwards Lifesciences Corporation. All rights reserved. AR07967
Edwards Lifesciences Irvine, USA I Nyon, Switzerland I Tokyo, Japan I Singapore, Singapore I São Paulo, Brazil edwards.com
2012-2013
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GE HEALTHCARE
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E Healthcare’s broad expertise across the perioperative care area is the byproduct of a century of anesthesia innovation. The creative ideas of a small Ohio company in 1910, the predecessor to the Anesthesia division of GE Healthcare, have evolved into ideas that continue to open new frontiers in anesthesia. From the operating room to the surgery center, GE’s broad anesthesia portfolio is ready to meet today’s clinical demands.
Uncompromised Ventilation … GE’s Carestation Today’s innovative vision for anesthesia delivery extends across three digital dimensions. Branded as Carestation,* the digital platform integrates therapy, patient monitoring and information management into an intelligent, connected system. Clinicians can appreciate their Carestation for what it delivers in the operating room, and CFOs enjoy the added peace of mind knowing that their investment can prepare them for future technology advancements when available. Recent software enhancements to the Aisys and Avance Carestations arm clinicians with tools they can use to automate lung procedures, helping to increase positive pressure in the airways. The lung ventilation procedures of Vital Capacity and Cycling may be useful for clinicians helping with patients experiencing lung complications during anesthesia. Neonatal ventilation capabilities are also a new feature available in Aisys and Avance. A neonatal patient’s physiology and small physical size make effective mechanical ventilation much more challenging. With the Aisys and Avance Carestations—designed and specified for neonatal patients—anesthesiologists can confidently deliver volumes as low as 5mL† to the patient. Fast and accurate; what you set is what you get. Contact your GE Healthcare representative to learn more about our entire portfolio of anesthesia delivery solutions and determine the best fit for your facility.
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Patient Monitoring, Clinical Support And More GE’s robust line-up of perioperative monitoring solutions target a broad range of patient acuity. GE’s CARESCAPE* Monitor B850 and B650 offer flexible and scalable solutions that provide access to the right clinical information, when and where it is needed. Navigator Applications Suite* is a digital clinical decision support tool available with Carestation that puts relevant, reliable and predictive information at your fingertips. The Navigator Applications Suite analyzes drug therapy information to help model and predict the effect of supported anesthesia-related drugs and drug synergies. Navigator helps provide valuable information to support you in optimizing patient management based on your clinical judgment.
With You From Start to Finish: Accessories, Service, Financing and More Turn to GE for your perioperative needs. From anesthesia delivery and patient monitors to ultrasound and clinical consumables, having us as your single-source solution saves time and helps reduce the hassle of coping with multiple vendors. GE Healthcare also offers a variety of service support options and a comprehensive technical support department committed to keeping your facility running smoothly—with minimal downtime.
Healthymagination Healthymagination is GE Healthcare’s $6 billion commitment to global health. Through this effort, GE is touching more lives through innovation and strategic partnerships developed in response to two simple questions: What are the biggest challenges facing health care consumers and providers, and how can we help? Headquartered in the United Kingdom, GE Healthcare is a $17 billion unit of General Electric Company
AT A GLANCE ADDRESS 3000 North Grandview Blvd. Waukesha, WI 53188 Phone: (262) 544-3011 Fax: (262) 548-2244 Web site: www.gehealthcare.com
PRODUCTS Anesthesia Carestations and ventilators; decision support tools; patient monitors; monitoring systems for the entire perioperative environment; information management systems and remote viewing; networking solutions; and related services, supplies and accessories; ultrasound; surgical equipment.
PRESIDENT AND CEO, GE HEALTHCARE John Dineen
PRESIDENT AND CEO, GE HEALTHCARE SYSTEMS Tom Gentile
(NYSE: GE). Worldwide, GE Healthcare employs more than 53,000 people committed to serving health care professionals and their patients in more than 100 countries. For more information about GE Healthcare, visit the Web site at www.gehealthcare.com. * GE, GE Monogram, Aespire, Aestiva, Aisys, Carestation, CARESCAPE, Centricity and Navigator Application Suite are trademarks of General Electric Company. † In Pressure Mode Ventilation
There is a lot of ability in a Carestation! GE Aisys Carestation with CARESCAPE Monitor B850
Anesthesiology News • August 2012
This corporate profile was reviewed and approved by GE Healthcare.
2012-2013
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MCMAHON PUBLISHING
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cMahon Publishing was founded in 1972 by Raymond E. McMahon and has grown to become one of the nationâ&#x20AC;&#x2122;s largest familyowned medical publishers. McMahon publishes a broad array of medical newsmagazines in various specialties, including anesthesiology, gastroenterology, general surgery, hospital pharmacy, infectious diseases, pain medicine, rheumatology and oncology. The combined circulation of McMahon Publishing publications is approximately 250,000 doctors and pharmacists. McMahon newsmagazines are accompanied by a full line of digital media, including Web sites, e-Newsletters, digital editions, podcasts, Twitter feeds and other digital communication to readers. Foremost among McMahon publications is Anesthesiology News. Now in its 38th year, Anesthesiology News has been the best-read publication in the field for the past 15 years (according to Kantar Media). Nearly 95% of the 45,425 U.S.-based anesthesiologists read this publication each month.
AT A GLANCE ADDRESS 545 W. 45th St., 8th Fl. New York, NY 10036 Phone: (212) 957-5300 Fax: (212) 957-7230 Web sites: www.mcmahonmed.com www.anesthesiologynews.com www.twitter.com/anesthesianews
PRODUCTS Medical newsmagazines, custom medical publications, educational reviews, educational and instructional pocket guides, special editions.
EMPLOYEES 70
PUBLISHER, CEO AND MANAGING PARTNER Raymond E. McMahon
GENERAL MANAGER, PARTNER Matthew McMahon
ANESTHESIOLOGY NEWS Senior Group Publication Director Richard Tuorto Manager, Publication Sales Angela Labrozzi Account Manager David Nathanson Junior Sales Associate, Classifieds Alina Dasgupta Managing Editor Adam Marcus Production Manager Martin Barbieri Art Director Blake Dennis
27 This corporate profile was reviewed and approved by McMahon Publishing.
Anesthesiology News â&#x20AC;˘ August 2012
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KARL STORZ ENDOSCOPY-AMERICA, INC.
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n 1945, in the small town of Tuttlingen, Germany, Dr. Karl Storz founded a company that has grown into a global corporation and international leader in the field of endoscopy. Today, the KARL STORZ organization, although still a family-held company, has offices and distribution agents in more than 38 countries worldwide. Now celebrating more than 65 years in business, a significant milestone for a family-owned enterprise, the KARL STORZ company has what is probably the industry’s most complete line of endoscopic equipment, with an extensive range of products encompassing more than 15 specialty areas, allowing true standardization with one company. KARL STORZ Endoscopy-America offers an array of products to simplify tracheal intubation and other airway management applications—including emergency and unexpectedly difficult intubations. Fiber-optic video intubation scopes, optical intubation stylets and video laryngoscopes create a comprehensive video intubation system. Fiberscopes specially designed for intubations have sandblasted shafts for easy insertion of endotracheal tubes, with no need for lubricants. Other products include ergonomically optimized airway carts and standard laryngoscope blades with brilliant LED light sources. A critical facet of the company’s latest airway management products is its focus on offering systems-based solutions, rather than standalone devices. The result is product offerings that combine exceptional portability, affordability and flexibility.
A History of Milestones The KARL STORZ company’s history of innovation includes the extracorporeal electronic flash (1956), cold light source (1960), Hopkins® rod lens system (1965), ultrasound lithotriptor (1970), direct-coupled interface endoscopes (1999) and OR1® Integrated Surgical Suites (2000). In 2001, the company launched the first fully digital imaging system, Image 1®, and its 1080p60 Image 1® high-definition video platform was released just six years later. And, KARL STORZ introduced its first video laryngoscope to the market in 2002.
shaped blade also facilitates training, while its video output feature allows simultaneous viewing that enhances difficult airway management and teaching. The C-MAC® system has benefited from the addition of Miller blades in sizes 0 and 1 for pediatric and neonatal intubations. And, a specialized blade, the dBLADE®, which has a very acute angle, facilitates intubation of patients with very anterior airways. In the first clinical evaluation of the C-MAC® dBLADE®, it was found that the highly angulated blade afforded a good view of the glottis, resulting in successful intubation of patients with difficult airways.2 KARL STORZ is the only company now offering eight different reusable and highly durable video laryngoscope blades. KARL STORZ Brite Blade™ laryngoscopes, with patented LED technology, continue to provide the brightest illumination of the airway among “green standard” intubating laryngoscopes. A “stubby handle” Brite Blade also is available, with a shorter handle that facilitates techniques used for pediatric and neonatal intubations. The stubby handle also allows easier positioning of the laryngoscope in obese patients whose greater chest wall mass can impede proper placement of standard laryngoscopes. Expanding on the successful C-MAC® video laryngoscope, the new C-CAM™ and C-HUB® platform represents an innovative system-based approach to airway management. The C-CAM™ camera head used on the portable C-MAC® video screen incorporates the latest CMOS technology to provide a superior solution for applications with flexible intubation fiberscopes and optical stylets. The ultra-small, ultra-light device is easy to hold and control, and provides plug-and-play ease of use. With it, the C-MAC® becomes a system for airway management combining video laryngoscopy with flexible fiberscopes and optical stylets. The C-HUB® platform allows direct connection with C-CAM™, flexible CMOS intubation scopes and C-MAC® laryngoscope blades, or to any size of external display, as well as directly to any computer interface.
Recent Notable Advancements
AT A GLANCE ADDRESS 2151 E. Grand Ave. El Segundo, CA 90245-5017 Phone: (424) 218-8100; (800) 421-0837 Web site: www.karlstorz.com
PRODUCTS Intubation fiberscopes, video laryngoscopes (CMOS and fiber-optic), standard laryngoscopes (LED and xenon light), optical intubation stylets, complete airway management cart solutions, OR integration and telemedicine.
EMPLOYEES More than 4,200 worldwide
PARENT COMPANY KARL STORZ GmbH & Co. KG
PRESIDENT AND COO Charlie Wilhelm
The C-HUB® can also be used in integrated operating rooms to route the signal to any mounted monitor without interfering with the surgical video equipment. The new C-MAC® Pocket Monitor is as handy as a direct laryngoscope but offers all the advantages of video laryngoscopy, incorporating a small LCD monitor right on the laryngoscope handle. Small enough to fit in your pocket, it can be used with all existing stainless-steel C-MAC® blades. The revolutionary design of the C-MAC® Flexible Intubation Video Endoscope (FIVE) pairs a digital video chip with an LED light source in the tip of the scope for a crisp, full-size image. It is compatible with the C-MAC® platform, plugging into either the C-MAC® monitor for a highly portable solution or the C-HUB® module which works within any integrated OR setting.
KARL STORZ video laryngoscope blades have been shown to be beneficial in performing tracheal intubation in difficult airways.1 The portable C-MAC® Video Intubation System has been designed for both expected and unexpected difficult airway situations, as well as standard intubations. Standard Macintosh blades are used to promote ease of use, with a reduced learning curve. The standard
References 1. Jungbauer A, Schumann M, Brunkhorst V, Börgers A, Groeben H. Expected difficult tracheal intubation: a prospective comparison of direct laryngoscopy and video laryngoscopy in 200 patients. Br J Anaesth 2009;102:546-550. 2. Cavus E, Neumann T, Doerges V, et al. First clinical evaluation of the C-MAC® dBlade® videolaryngoscope during routine and difficult intubation. Anesth Analg 2011;112:382-385.
KARL STORZ offers an array of airway management solutions on one video platform.
28 Anesthesiology News • August 2012
C-MAC® Pocket Monitor can be used with all existing stainless-steel C-MAC® blades.
This corporate profile was reviewed and approved by KARL STORZ Endoscopy-America, Inc.
C-MAC® – Make your Video Laryngoscope a SYSTEM! A Single Instrument is not Airway Management
KARL STORZ Endoscopy-America, Inc., 2151 E. Grand Ave, El Segundo, CA 90245, USA, Phone: (424) 218-8100, Fax: (800) 321-1304, E-Mail: info@karlstorz.com KARL STORZ GmbH & Co. KG, Mittelstraße 8, D-78532 Tuttlingen/Germany, Phone: + 49 7461 / 70 80, Fax: 07461 / 70 81 05, E-Mail: karlstorz-marketing@karlstorz.de KARL STORZ Endoscopy Canada, Ltd., 2345 Argentia Road, Suite 100, Mississauga, Ontario, Canada L5N 8K4, Phone: (800) 268-4880, Fax: (905) 858-0933 KARL STORZ Endoscopia, Latino-America, 815 NW 57 Ave, Suite #480, Miami, Florida 33126-2042, USA, Telefono: (305) 262-8980, Telefax: (305) 262-8986 A-0112002
www.karlstorz.com
© 2012 KARL STORZ Endoscopy-America, Inc.
2012-2013
Corporate Profiles
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LMA NORTH AMERICA
L
MA North America is dedicated to improving patient care through the sale of high-quality and innovative products for anesthesia and airway management. The LMA™ products are recognized for their proven superior clinical efficacy and the quality assured by the LMA brand. These competitive strengths, together with solid customer relationships, have positioned LMA as the leader in the global arena of advanced anesthesia airway devices. LMA products are sold in more than 100 countries through direct sales teams and independent distributors in other markets. Operations are backed by an experienced R&D team and a scientific advisory board that includes Archie Brain, MD, and several other prominent clinical consultants. LMA is committed to the development of new products and research that aim to extend the boundaries of traditional anesthesia and deliver devices that enable clinicians to consistently raise the standards of patient care.
LMA North America Family Of Products
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The LMA airways have a proven track record of safety and efficacy. LMA airways have been used more than 300 million times, building on a 20-year history of innovation and trust. The subject of more than 3,000 clinical references, each LMA airway has been carefully designed and tested to meet exacting standards. Today, they are used in approximately one-third of all general anesthesia cases in the United States. LMA airways are included in the American Heart Association Guidelines for Resuscitation and the American Society of Anesthesiologists Difficult Airway Algorithm. The LMA Supreme™ is the first single-use LMA with a built-in drain tube designed to channel fluid and gas safely away from the airway. The carefully tested design provides an effective Second Seal™ that can be easily established and verified. This significantly elevates the safety and efficacy of the laryngeal mask in routine cases and makes it possible to extend LMA use to more challenging cases. LMA Pain Management™ introduces the LMA Autofuser™ products by Ace Medical to provide postoperative pain relief for patients undergoing surgical procedures. The portfolio includes products for site-specific infusion of analgesic agents as well as devices designed for continuous peripheral nerve blocks (CPNBs). The products are compact, lightweight and easy to use and have been shown to significantly mitigate postoperative pain for up to three days. CPNB is an increasingly popular and costeffective therapy that offers benefits over systemic analgesics and single-shot injections. LMA also is proud to introduce the addition of the Boussignac CPAP and a line of one-lung ventilation products by Fuji Systems Corporation to the LMA Airway Management™ portfolio. The Boussignac CPAP is the first completely open system that offers patients ventilatory support, reducing intubation rates and relieving symptoms. The design of the Boussignac has allowed CPAP to become simple, lightweight and cost-effective, while still performing as effectively as much larger
Anesthesiology News • August 2012
and more expensive equipment. The Uniblocker™ by LMA is designed for endobronchial blockade of the left or right lung in procedures requiring one-lung ventilation. Ideal for difficult airways, the Uniblocker is easy to direct and allows for smooth placement of the blocker into the target mainstem bronchus. The LMA Atomization™ family of products provides a simple-to-use, needle-free solution for drug delivery. The LMA MAD Nasal™ Intranasal Mucosal Atomization Device is the safe and painless way to deliver medication directly into your patient’s bloodstream without an intravenous line. The LMA MADgic Airway™ Intubating Airway with Mucosal Atomization and Oxygen Delivery is the most innovative choice to create a temporary airway to facilitate fiber-optic intubation combining atomized topical anesthetic and oxygen delivery in an innovative and elegantly designed oral airway. The LMA MADgic™ Laryngo-Tracheal Mucosal Atomization Device is the most versatile choice to administer medication across the entire upper airway and beyond the vocal cords. LMA Visualization™ McGRATH® Series 5 and HLDi video laryngoscopes are fully portable and designed to provide a clear view of the vocal cords during intubation. A small camera with a powerful light source is located at the distal end of the blade. Once a clear image
AT A GLANCE ADDRESS 4660 La Jolla Village Dr., Ste. 900 San Diego, CA 92122 Phone: (800) 788-7999 Web site: www.LMANA.com
PRODUCTS LMA Airway Management™, LMA Atomization™, LMA EMS™, LMA Visualization™, LMA Pain Management™
EMPLOYEES 95
CHIEF EXECUTIVE OFFICER Steven R. Block
of the vocal cords and surrounding anatomy is obtained, a standard endotracheal tube is then guided by the clinician through the vocal cords and into the larynx while viewed in real time on the color video display. LMA EMS™ offers four different rescue airway options plus a needle-free solution for drug delivery, because in an emergency time means everything. A few minutes can be the difference between life and death. LMA understands that with precious few seconds available to choose a rescue airway device, the decision is a critical one.
Services and Education
LMA Supreme™
LMA MAD Nasal™ Intranasal Mucosal Atomization Device
LMA AutoFuser™
LMA North America is committed to clinical education and invests significant resources to educate clinicians through airway seminars, visiting lecturer programs and hands-on workshops. The company supports anesthesia research through organizations such as the Society for Airway Management, the American Society of Anesthesiologists and the Anesthesia Patient Safety Foundation. There are Centers of Excellence in Padova, Italy, and Singapore, and an exclusive training agreement with the Brazilian Anesthesiology Society. LMA North America provides grants and other support to teaching hospitals. The company supplements these activities with an extensive library of clinical articles and instructional materials on its Web site and in multimedia formats. Most recently, LMA attended the opening ceremony of the Archie Brain Difficult Airway Simulation Center, which aims to provide airway management training for health care professionals of all levels. LMA and the Cleveland Clinic have collaborated to create the simulation suite within the new Cleveland Clinic Multidisciplinary Simulation Center. The cutting-edge simulation center has been designed to support airway management training for physicians, residents, nurses and emergency service responders throughout the Cleveland Clinic Health System.
This corporate profile was reviewed and approved by LMA North America.
Breathe easier.
Introducing the LMA MADgic Airway™ – the most versatile choice for all of your difficult and awake intubations requiring a fiberoptic scope. The LMA MADgic Airway™ will have you breathing a sigh of relief with innovative features that combine targeted topical anesthetic atomization and oxygen delivery directly to the glottic opening, all while providing maximum protection of the fiberoptic scope. LMA MADgic Airway™ provides the features you need for your difficult intubations combined into a single, elegantly designed fiberoptic oral airway.
For more information contact your LMA™ representative or visit LMANA.com. LMA FAMILY OF PRODUCTS LMA Atomization™
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LMA Airway Management™
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LMA EMS™
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LMA Visualization™
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LMA Pain Management™
LMA North America, Inc., 4660 La Jolla Village Dr., Suite 900 San Diego, CA 92122 P: 800-788-7999 F: 858-622-4130 Copyright © 2012, The Laryngeal Mask Company Limited LMA. LMA, LMA Better by Design, LMA Atomization, LMA MADgic Airway, and MAD are trademarks of the LMA Group of companies. LMA 617-07/12
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MAQUET MEDICAL SYSTEMS USA The Gold Standard
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AQUET Medical Systems USA is a market-leading medical company in the United States whose mission is to improve patient outcomes and quality of life through advanced technology. MAQUET designs, develops and distributes innovative products and therapeutic solutions, and provides infrastructure capabilities for the hybrid operating room (OR), general OR, intensive care unit (ICU) and patient transport within acute care hospitals. MAQUET has a long history of innovation in anesthesia, beginning with the introduction of its first anesthesia machine in 1981. Since then, the company has delivered more than 6,500 units to hospitals worldwide. It also has set market standards with its high-performance SERVO ventilation platform for more than 40 years. The company has a deep understanding of mechanical ventilation and the challenges facing anesthesiologists today. Not only are patient demographics constantly shifting, but surgical procedures are becoming more complex on a daily basis, necessitating advanced technology to ensure optimal patient care. MAQUET invests significantly in research and development to meet the changing needs of hospitals and anesthesiologists and ensure that it can provide anesthesia products that offer high-performance ventilation and support capabilities. MAQUET’s flagship anesthesia product, the FLOW-i Anesthesia Delivery System with high-performance SERVO ventilation, offers true ICU ventilator performance and effective anesthesia delivery from the same unit.
FLOW-i Anesthesia Delivery System With High-Performance SERVO Ventilation MAQUET’s FLOW-i Anesthesia Delivery System seamlessly combines high-performance SERVO ventilation with precise anesthesia delivery to help meet the needs of all patients. These include the most challenging
AT A GLANCE cases, such as obese patients with high abdominal and thoracic pressures, older patients suffering from multiple medical conditions, the critically ill and the smallest neonates. FLOW-i reacts quickly to changing parameters as the low internal system volume enables rapid changes in gas concentration when needed, and facilitates fast wash-in and wash-out of the anesthetic agent. This process helps to minimize waste and unnecessary use of the agent through precise delivery technology.
High-Performance Ventilation Features • Set tidal volume is accurately delivered even under high abdominal and thoracic pressure, helping to avoid hypoventilation • Fast rise time and high flow rates adapt to varying inspiratory demand in the presence of increasing airway pressure • Sensitive triggering improves synchrony in pediatric patients and those with decreased respiratory drive • Consistent and accurate PEEP levels are maintained • Controlled pressure drop during expiration decreases expiratory resistance and work of breathing, in addition to minimizing auto-PEEP at higher respiratory rates
Advanced Design and Technology The FLOW-i system’s ergonomically designed, fully electronic platform and touch-screen interface are easy to use and upgrade for enhanced workflow today and in the future. The open architecture allows hospitals to add the patient monitor and data management system of their choice and easily integrate future software and hardware advances into the system—increasing cost efficiency by avoiding the need for costly equipment replacement or upgrades. In addition, clinician ease of use and comfort are engineered into every FLOW-i
U.S. HEADQUARTERS MAQUET Medical Systems USA 45 Barbour Pond Dr. Wayne, NJ 07470 (888) 627-8383 www.maquetusa.com
PRODUCTS Intensive care ventilators and anesthesia machines, suite of cardiovascular products (for intra-aortic balloon counterpulsation, cardiac assist, coronary artery bypass surgery, aortic and peripheral vascular surgery, and extracorporeal circulation), flexible room design for OR and ICU, OR tables, lights and ceiling supply units and OR integration
EMPLOYEES 6,000 MAQUET employees in 50 international sales and service organizations, as well as a network of more than 280 sales representatives
PRESIDENT AND CEO Raoul Quintero
machine with its height adjustability, movable arms and integrated table light.
Innovative Volume Reflector™ Re-Breathing Technology The FLOW-i system features the innovative Volume Reflector technology to ensure that the breathing circuit will never be empty and ventilation will remain uninterrupted regardless of surgical constraints, changing conditions or patient position. The re-breathing technology consists of a rigid reservoir to minimize internal system volume for high ventilation performance. It replaces both the traditional bag-in-bottle (bellows) and the piston, allowing the partial re-administration of rebreathed gas to the patient via the circle system. Oxygen-driven by design, the Volume Reflector helps to minimize the risk for delivering a potentially dangerous hypoxic mixture in the presence of leaks during lowflow anesthesia. FLOW-i also contains anesthetic agent injection vaporizers that are fully electronic, are lightweight and can be refilled while slotted in the machine, even when one is still in use.
Learn More To learn more about the MAQUET FLOW-i Anesthesia Delivery System, please visit www.maquetusa.com.
32 Anesthesiology News • August 2012
This corporate profile was reviewed and approved by MAQUET Medical Systems USA.
EVERY CHALLENGE. EVERY PATIENT. EVERY BREATH.
Introducing FLOW-i ® Anesthesia Delivery System Safe and versatile anesthesia delivery for routine and challenging patients. Innovative Volume Reflector™ re-breathing technology ensures that the breathing circuit will never be empty and ventilation remains uninterrupted at all times Electronic injector vaporizers and small system volume for quick and efficient wash-in and wash-out of anesthetic agent High performance SERVO ventilation combined with precise anesthesia delivery helps meet the needs of all patients—including the most difficult cases Ergonomically designed, fully electronic platform is easy to use and upgradeable for enhanced workflow today and in the future FLOW-i Anesthesia Delivery System Making the exceptional routine www.maquet.com
® MAQUET Is a Registered Trademark of MAQUET GmbH & Co. KG. 2011 Copyright MAQUET Cardiovascular LLC or its affiliates. All rights reserved. Caution: U.S. Federal Law restricts this device to sale by or on the order of a physician. Refer to Instructions for Use for current indications, warnings, contraindications, and precautions.
2012-2013
Corporate Profiles
ANNUAL
MASIMO Taking Noninvasive Monitoring to New Sites and Applications
F
or more than 20 years, Masimo has focused on a singular mission—to help clinicians improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications.
Oxygenation Monitoring During Challenging Conditions Masimo Signal Extraction Technology (Masimo SET®) pulse oximetry is the proven leader in pulse oximetry, shown by both clinical research and the real-world success of customers and partners. More than 100 independent and objective studies have shown that Masimo SET outperforms all other pulse oximetry technologies, providing clinicians with unmatched sensitivity and specificity to make critical patient care decisions even under the challenging conditions of motion and low perfusion.1
Transfusion Management And Bleeding Detection With Noninvasive and Continuous Hemoglobin Monitoring Masimo’s upgradable rainbow® SET platform also allows clinicians to measure noninvasive and continuous total hemoglobin (SpHb®), pleth variability index (PVI®), acoustic respiration rate (RRa™), oxygen content (SpOC™), carboxyhemoglobin (SpCO®) and methemoglobin (SpMet®), in addition to oxygen saturation (SpO2), pulse rate (PR) and perfusion index (PI). With rainbow® Pulse CO-Oximetry®, Masimo SpHb helps clinicians trend hemoglobin between invasive blood sampling to enable real-time patient management decisions. In a randomized controlled trial in orthopedic surgery at Massachusetts General Hospital, clinicians using SpHb reduced blood transfused by 90%.2 During and after surgery, clinicians indicate that with SpHb, real-time hemoglobin assessment has helped to more quickly identify blood loss. In these situations, earlier identification allows clinicians to act sooner to treat the patient, which can make an enormous difference in recovery, the ICU and labor and delivery wards.2
Helping Clinicians Assess Fluid Responsiveness With Pleth Variability Index Although it is critical to improving patient status and enabling end-organ preservation, unnecessary fluid administration is associated with increased morbidity and mortality.3 Traditional invasive measurements
34
The 2012 Radical-7, with intuitive touch screen, standard integrated wireless connectivity and fullscreen trending
Anesthesiology News • August 2012
AT A GLANCE
do not reliably predict fluid responsiveness and newer dynamic indices are invasive, complex and/or costly.4 Masimo pleth variability index (PVI) measures the dynamic change in the plethysmograph waveform over the respiratory cycle and has been shown to help clinicians assess fluid responsiveness in adult surgical and intensive care patients under mechanical ventilation.5,6 Studies have shown PVI performs similarly to more invasive and costly dynamic fluid assessment technologies.7 Masimo PVI also has been shown to help clinicians improve fluid management to decrease patient risk in a randomized controlled trial.8
ADDRESS 40 Parker Irvine, CA 92618 Phone: (949) 297-7000 Web site: www.masimo.com
PRODUCTS Masimo SET pulse oximetry; rainbow® Pulse CO-Oximetry and sensors; rainbow® Acoustic Monitoring; SEDLine brain function monitoring; and Patient SafetyNet general floor monitoring.
Ventilation Monitoring With Acoustic Respiration Rate
MISSION STATEMENT
Continuous monitoring of respiration rate is especially important for post-surgical patients receiving patient-controlled analgesia for pain management due to the serious risks of respiratory depression. Masimo’s rainbow® Acoustic Monitoring provides noninvasive and continuous respiration rate (RRa) through an adhesive acoustic sensor easily and comfortably placed on the patient’s neck. RRa has shown similar respiration rate accuracy to capnography9 and higher sensitivity to detect breathing cessation compared with capnography,10 and its use results in enhanced patient compliance.11 RRa may facilitate earlier detection of respiratory compromise and patient distress—and offer a breakthrough in patient safety for post-surgical patients on the general floor and for procedures requiring conscious sedation.
Improving patient outcomes and reducing cost of care by taking noninvasive monitoring to new sites and applications.
EMPLOYEES 2,500
FOUNDER AND CEO Joe Kiani
or severe brain damage due to opioid depression on the original orthopedic unit.14
References 1.
Anesthesia Monitoring With SEDLine SEDLine® brain function monitoring provides advanced electroencephalogram (EEG) data to improve the care of patients under anesthesia or sedation, while offering reliable monitoring during challenging conditions such as electrocautery. Use of SEDLine and its Patient State Index (PSI™) enables individualized titration and has been shown to help clinicians manage patients to significantly faster emergence from anesthesia and faster recovery.12
2.
3.
4.
5.
6.
Post-Surgical Monitoring With Masimo Patient SafetyNet The Masimo Patient SafetyNetTM system combines Masimo SET pulse oximetry, breakthrough rainbow® measurements and remote patient monitoring with wireless clinician alerts for patient safety on general care floors. After implementing Masimo SET and Patient SafetyNet in a post-surgical orthopedic floor where only intermittent spot checking had been used before, Dartmouth-Hitchcock Medical Center reduced rescue events by 65%, ICU transfers by 48% and annualized ICU bed usage by 135 days.13 This led to an opportunity-cost savings of $1.48 million on one floor alone based on a reduced ICU transfer rate.14 A follow up report indicated similar reductions on two additional post-surgical floors and that after four years there have been no deaths
7.
8.
9.
10. 11. 12.
13.
14.
Shah N, Ragaswamy HB, Govindugari K, Estanol L. Performance of three new-generation pulse oximeters during motion and low perfusion in volunteers. J Clin Anesth. 2012 May 22 (Epub ahead of print). Colquhoun DA, Forkin KT, Durieux ME, Thiele RH. Ability of the Masimo pulse CO-Oximeter to detect changes in hemoglobin. J Clin Monit Comput. 2012;26:69-73. Bundgaard-Nielsen M, Holte K, Secher NH, Kehlet H. Monitoring of perioperative fluid administration by individualized goal-directed therapy. Acta Anaesthesiol Scand. 2007;51:331-340. Manoach S, Weingart SD, Charchaflieh J. The evolution and current use of invasive hemodynamic monitoring for predicting volume responsiveness during resuscitation, perioperative, and critical care. J Clin Anesth. 2012;24:242-250. Cannesson M, Desebbe O, Rosamel P, et al. Pleth variability index to monitor the respiratory variations in the pulse oximeter plethysmographic waveform amplitude and predict fluid responsiveness in the operating theatre. Br J Anaesth. 2008;101:200-206. Loupec T, Nanadoumgar H, Frasca D, et al. Pleth variability index predicts fluid responsiveness in critically ill patients. Crit Care Med. 2011;39:294-299. Zimmermann M, Feibicke T, Keyl C, et al. Accuracy of stroke volume variation compared with pleth variability index to predict fluid responsiveness in mechanically ventilated patients undergoing major surgery. Eur J Anaesthesiol. 2010;27:555-561. Forget P, Lois F, de Kock M. Goal-directed fluid management based on the pulse oximeter-derived pleth variability index reduces lactate levels and improves fluid management. Anesth Analg. 2010;111:910-914. Mimoz O, Benard T, Gaucher A, Frasca D, Debaene B. Accuracy of respiratory rate monitoring using a non-invasive acoustic method after general anaesthesia. Br J Anaesth. 2012;108:872-875. Ramsay M, et al. PostGraduate Assembly in Anesthesiology 2011. P-1937. Macknet MR, et al. American Society of Anesthesiologists Annual Meeting 2007; A84. Drover DR, Lemmens HJ, Pierce ET, et al. Patient State Index: titration of delivery and recovery from propofol, alfentanil, and nitrous oxide anesthesia. Anesthesiology. 2002;97:82-89. Taenzer AH, Pyke JB, McGrath SP, Blike GT. Impact of pulse oximetry surveillance on rescue events and intensive care unit transfers: a before-andafter concurrence study. Anesthesiology. 2010;112:282-287. Taenzer AH, Blike GT. Postoperative monitoring—the Dartmouth experience. APSF Newsletter. 2012;27:1.
This corporate profile was reviewed and approved by Masimo.
Breakthrough Measurements. Breakthrough Monitor.
Introducing the 2012
™
Radical-7
Once again raising the technologic bar, the new Radical-7 is designed to automate the process of care and enable clinicians to instantly adapt to changing monitoring needs in individual patients and care areas. > Breakthrough noninvasive measurements: · Total Hemoglobin (SpHb )
· Pleth Variability Index (PVI )
· Oxygen Content (SpOC™)
· Acoustic Respiration Rate (RRa™)
· Methemoglobin (SpMet )
· Carboxyhemglobin (SpCO )
®
®
®
> Instantly adaptable functionality
> Intuitive touch screen operation
> Integrated wireless connectivity
> Easy customization
For more information, visit www.masimo.com/2012Radical-7 800-257-3810 © 2012 Masimo Corporation. All rights reserved.
®
2012-2013
Corporate Profiles
ANNUAL
NONIN MEDICAL, INC. The Inventor of Fingertip Pulse Oximetry and a Leader In NIRS-based Medical Monitoring Innovations
N
onin Medical, Inc., is a global leader in designing and manufacturing noninvasive physiological monitoring solutions. Nonin invented near infrared spectroscopy (NIRS)-based fingertip pulse oximetry with the Onyx® Model 9500, so extending its product offerings to include accurate, durable, portable, NIRS-based tissue oximeters and capnograph/pulse oximeters was a natural one. Nonin’s product franchise includes pulse oximeters, regional oximeters, capnographs, sensors, software and accessories. Headquartered in Minneapolis, Minnesota, with an additional sales, distribution and service center in Hudiksvall, Sweden, Nonin Medical sells its products to clinicians and consumers in more than 125 countries and has more than 100 OEM partners worldwide. Today, Nonin’s clinically proven EQUANOX™ rSO2, MedAir™ EtCO2 and PureSAT® SpO2 technologies— known for their stability, signal processing speed and ability to uniquely filter out artifact interference—provide confidence to millions of clinicians that the numerical values they see reflect their patients’ true physiology, even in the presence of low perfusion, motion and other challenging conditions.
AT A GLANCE
Accurate, Portable Cerebral/Somatic Tissue Oximeters (rSO2) The EQUANOX™ Model 7600 Cerebral/Somatic Tissue Oximetry System is a NIRS-based monitoring device that noninvasively and continuously detects oxygen saturation status in brain and other tissues. The device allows clinicians to quickly react to reverse harmful tissue ischemia events before those events become critical.
Key Nonin Medical advantages include: • Cerebral and Somatic Monitoring – Up to four channels displayed on one screen for monitoring oxygen saturation in the brain and somatic sites on the body, including kidney and liver sites • Sensors Optimized for the Patient – Unique optical spacing to isolate and target key tissues for the intended population, from neonates to adults • Absolute or Trending Accuracy – Assures accurate measure of tissue saturation at a point in time or over a period of time • Consistency and Reliability – Rapid, reliable response to change without signal instability and interruptions from ambient electrical and light interferences • Portability and Connectivity – Lightweight, durable monitor with long battery life and pole-mounting capability for continually monitoring patients during intra-hospital transport. Data output available via Bluetooth® wireless technology or RS232 connection. Interfaces with Philips® VueLink (through Philips IntelliVue® Monitor), Philips CompuRecord Anesthesia Information System, Spectrum Medical VIPER Independent Data Management System and Sorin Perfusion Data Management System.
36
*Validation data on file, Nonin Medical. Accuracy for EQUANOX™ Advance 8004CA sensor only.
Anesthesiology News • August 2012
13700 1st Ave. North Plymouth, MN 55441-5443 Phone: (763) 553-9969 Fax: (763) 553-7807 Customer Service: (800) 356-8874 Email: info@nonin.com Web site: www.nonin.com
OVERVIEW: Nonin Medical is a U.S.-based, technology-driven company that designs, manufactures and sells noninvasive medical monitoring devices for clinicians, consumers and OEM customers worldwide. Products include pulse oximeters, cerebral/ somatic tissue oximeters, capnographs, sensors, software and accessories. Nonin Medical is known for its innovative, accurate, easy-to-use products and exceptional customer service.
MedAir™ EtCO2 technology delivers the earliest indicator of an adverse event in the breathing function of a patient.
Key Nonin Medical advantages include:
Ideal for end-tidal carbon dioxide (EtCO2) monitoring anywhere anesthetic sedation is administered, Nonin’s
• Fast, first breath detection of respiratory rate and EtCO2 • Highly visible, widescreen display • Easy to use • Can be easily mounted on a pole or a bed rail • Unique moisture management • Cost-effective to purchase and operate with standard tubing
Nonin’s new EQUANOX Advance 8004CB Series Sensor is the first and only sensor to automatically adjust for neonatal/pediatric brain myelination changes for a single-sensor solution that provides oxygen saturation readings based on the child’s true physiology. www.noninequanox.com
Highly portable with a widescreen touch-panel display, the LifeSense® (with EtCO2 and SpO2 monitoring), and RespSense™ (with EtCO2 monitoring) monitors are accurate, easy-to-use capnographs for infants through adults. www.nonin.com/capnography
Portable, Easy-to-Read Capnographs (EtCO2)
Nonin’s EQUANOX 7600 system is the first and only cerebral/somatic tissue oximeter to use a dual light emitting and detecting sensor architecture for industry-leading accuracy.* www.noninequanox.com
CORPORATE HEADQUARTERS:
This corporate profile was reviewed and approved by Nonin Medical, Inc.
2012-2013
Corporate Profiles
ANNUAL
SHERIDAN HEALTHCARE, INC.
T
he question is not whether our health care industry is changing. The most pressing question is how and whether the health care industry is prepared to adapt to the changes. With a 59-year tradition, Sheridan Healthcare, Inc. has successfully expanded and continuously adapted within a changing health care industry, focusing first and foremost on the patient’s well-being and satisfaction and investing in people and infrastructure to support its mission. As one of the nation’s largest providers of anesthesia services, Sheridan’s goal is to deliver quality clinical services to its client facilities through the dedication of its accomplished clinical professionals. From this strong foundation and professional culture, Sheridan has maintained one of the highest retention rates in the industry, both among providers and clients. Physician led and managed, Sheridan understands the needs of providers and strives to improve their lives through consummate leadership, management support, effective training and positive work environments. These attributes enable providers to focus on what they do best: practice medicine. As Sheridan strives to embody performance, quality and innovation, the company finds that these three goals often overlap, intermingle and inform one another. Taken as a progression, these goals also can be viewed as stages in a process of defeating the denial, fear and instability that characterize how many leaders feel about health care in the United States. For health care leaders, passivity is the enemy and, following the old paradigm, promises the same inertia. If health care leaders can begin to think of quality, performance and innovation as one, if they can obliterate the old distinctions of “good enough” health care, then perhaps they can begin to look at the health care industry as something that can be composed.
Advantages to the Individual “There are many advantages to the individual anesthesia provider at Sheridan,” said Gilbert Drozdow, MD, MBA, president of Sheridan’s Anesthesia Division. “We offer extensive experience in anesthesia services, a robust business infrastructure and we are sensitive to the professional needs of our providers.” Lifestyle and the quality of life are important to providers. Sheridan offers extensive benefits to enhance and maintain job satisfaction—from income security to flexible scheduling and travel opportunities. Sheridan encourages its providers to grow professionally and embrace clinical leadership, both in client facilities and at the corporate level. The Sheridan Leadership Academy is the driving force of professional development at Sheridan, teaching clinical leaders to hone their skills to optimize service, improve clinical care and lead quality initiatives. Sheridan’s quality management team includes staff physicians and nurses who also lead
quality initiatives and provide a professional outlet for personal development.
Providing Business Benefits Sheridan is a metric-driven organization with systems to collect, evaluate and report data effectively. Continuous and timely feedback allows for improvements in efficiency and quality care. When a client facility outsources its medical and regulatory processes to Sheridan, clinicians are better able to focus clinically. Client facilities benefit from Sheridan’s vast experience in developing health care protocols, improving revenue cycle management, streamlining operating room management, ensuring successful accreditation, expediting credentialing and focusing on customer service. In addition to helping providers and clients meet and exceed their professional and strategic goals, clinical data allow Sheridan to prepare for and adapt to changes within the health care industry.
Industry Innovations Sheridan’s focus on adapting to change includes technological innovations, such as Inspire Health Solutions.™ This Sheridan subsidiary is committed to improving provider efficiency and effectiveness. Inspire supports Sheridan’s client facilities and physicians with Web-based features including electronic health records, clinical integration, decision support, revenue cycle management and productivity management solutions. Sheridan providers can rely on a supportive leadership and leverage our content specialists and operations managers to assist them in adapting to new technologies and clinical systems. “There is always a resource within our Anesthesia Services Division that can apply themselves to any project, regardless of its complexity,” said Dr. Drozdow. “And many times, solutions are readily available because they have already been addressed.”
AT A GLANCE ADDRESS Sheridan Healthcare, Inc. 1613 North Harrison Pkwy. Sunrise, FL 33323 Web site: www.sheridanhealthcare.com
SERVICES Multistate practice management company providing services in anesthesiology, emergency medicine, radiology and neonatology with pediatric subspecialties
VISION To deliver industry-leading health care solutions that demonstrate measurable excellence and value and make us indispensable to our customers
EMPLOYEES Medical providers: 1,836 Support: 600
CHAIRMAN AND CEO Mitchell Eisenberg, MD
PRESIDENT, ANESTHESIA SERVICES Gilbert Drozdow, MD, MBA
Growing Anesthesia Services With a new generation of anesthesia professionals entering a rapidly evolving health care environment, Sheridan remains confident in our ability to be both sensitive and flexible regarding the individual needs of providers. Sheridan extends an open invitation to individual anesthesia providers and group practices to visit our corporate site, learn more about our history and examine our supportive and value-enhancing infrastructure. “Our success has depended on a dedicated team of physician leaders willing to make a professional and personal investment in Sheridan’s progress,” Dr. Drozdow said. “We will continue to invest in our health care providers to build a successful company in our continually evolving industry.” * “Sheridan” includes Sheridan Healthcare, Inc., and its subsidiaries and affiliates.
38 Anesthesiology News • August 2012
This corporate profile was reviewed and approved by Sheridan Healthcare, Inc.
Precise performance. For hospitals, it begins with measurement. From the moment you partner with Sheridan, we meticulously seek out ways to help you achieve tangible results. We draw on our deep expertise to positively impact your patient care, productivity and efďŹ ciency. Every step of the way, we use our performance-driven metrics to connect clinical excellence and accountability to patient satisfaction.
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855-225-4089 s www.sheridanhealthcare.com
2012-2013
Corporate Profiles
ANNUAL
SPACELABS HEALTHCARE
S
pacelabs Healthcare is a comprehensive, perioperative solutions provider developing, manufacturing and distributing medical equipment and services throughout the world. We provide solutions for patient monitoring and connectivity, anesthesia delivery and ventilation, diagnostic cardiology and supplies and accessories, selling to hospitals, clinics and physician offices. Spacelabs’ world headquarters, in Issaquah, Wash., is where we develop and manufacture anesthesia, patient monitoring and cardiology products. Spacelabs provides various perioperative solutions from low to high acuity, covering simple to complex cases and pediatric to geriatric patients—offering you the choices you need in anesthesia delivery, patient monitoring and supplies and accessories. What’s more, you can configure solutions to satisfy your individual practices and preferences. Our product line is continually developing and expanding with some exciting new additions coming in the near future. Spacelabs Healthcare has more than 50 years of innovation and service and began as the innovator of life support systems for the Gemini and Apollo space missions. Always endeavoring to meet our customers’ unmet needs, the result is the complete rethinking of the anesthesia delivery system experience.
Welcome to ARKON Until today, anesthesia delivery systems were designed with functionality and reliability as the priority. While important, we saw these as our starting point. ARKON™ is our “evolutionary” new anesthesia delivery system that pushes the boundaries to provide advanced flexibility and ergonomics for you, the people who use these machines. ARKON puts your patient front and center—offering anesthesiologists the maximum in functionality, comfort and control. Through a combination of an expandable clinical console, which extends out to enable a wide-angle view of your clinical setting, and enhancements not previously available in the perioperative environment, we focused ARKON on you, so you can focus on your patient. While other machines concentrate on the technology of anesthesia delivery, we believe you will find ARKON unique in its attention to the details of how you work. Providing you with an improved workplace is our priority, with flexibility our focus. Designed to improve the user experience, ARKON is part of our mission to inspire the world to bring the best care to patients as well as their families.
Spacelabs Healthcare is dedicated to developing and supporting those tools.
Spacelabs Healthcare Collaborates With Clinicians To Provide Clinically Relevant Products Spacelabs Healthcare values the strong clinical partnerships that we have developed and maintained over the past half-century. Through continuous and effective communication with clinical user groups, we gather a deep understanding of needs and requirements in order to develop solutions to help clinicians achieve their goals. Always a leader in innovation with accessibility, continuity and partnership, Spacelabs Healthcare delivers on our promises to: • Help improve patient care. • Help clinicians achieve their goals. • Demonstrate honesty, reliability and integrity. • Deliver quality products and service, service, service.
AT A GLANCE SPACELABS HEALTHCARE 5150 220th Ave. SE Issaquah, WA 98029 Phone: (425) 657-7200 Web site: www.spacelabshealthcare.com
PRESIDENT AND CEO Nicholas Ong
When selecting a perioperative solutions company, consider Spacelabs’ experience and heritage of innovative and intuitive products developed in partnership with our customers to address real-life clinical needs. Our customer-first philosophy reflects our commitment to superior care for you and your patients as well as product support by our award-winning service team.
Excellence in Customer Service and Support At Spacelabs Healthcare, excellence in customer service and support are not just words; they are values, embraced by all our employees, that shape the way that we do business. As a result, IMV ServiceTrak™, one of the most respected surveys in the health care industry, ranked Spacelabs “Best for Overall Service Performance among Industry Peers” in 2011 for the second consecutive year, and three of the last five years. We work cooperatively to develop long-term relationships with our suppliers, our distribution partners and our customers to provide the products, tools and services you need. Spacelabs is a focused, agile organization that is here to serve health care professionals worldwide. Our goal is to provide our customers more time to care. Customer loyalty is our reward.
“The Spacelabs Advantage”
40
For more than 50 years, health care professionals have experienced the company’s proven commitment to connecting innovation with care; stability for a strong future; collaboration with clinical and technological partners; effective implementation of real-world solutions; and service wherever, whenever and however it’s needed. The most important factor in patient care is a knowledgeable medical professional with the right tools.
Anesthesiology News • August 2012
This corporate profile was reviewed and approved by Spacelabs Healthcare.
2012-2013
Corporate Profiles
ANNUAL
VERATHON MEDICAL A consistently clear airway view defines GlideScope video laryngoscopes
A
irways come in many shapes and sizes. Which is why GlideScope® video laryngoscopes are designed for a full spectrum of patients. From the digital AVL to the portable Ranger, reusable and single-use GlideScope configurations are available for the variety of cases you see every day. As your go-to device, the GlideScope video laryngoscope offers a wide field of view and a broad range of blade sizes for greater maneuverability. That makes it ideal for difficult airways and demanding settings, but also convenient for routine airways.
New Options for Preterm and Pediatric Patients
ADDRESS
The GlideScope AVL offers another big advancement for little airways with the addition of two single-use configurations: the “0” Stat for patients 1.5 kg and smaller, and the “2.5” Stat for patients 10 to 28 kg. There also is a newly designed, reusable GVL 2 for patients from 4 to 20 kg.
20001 North Creek Pkwy. Bothell, WA 98011 Phone: (800) 331-2313 (U.S. & Canada only); (425) 867-1348 Fax: (425) 883-2896 Web site: www.verathon.com
PRODUCTS Verathon designs, manufactures and distributes reliable, state-of-the-art medical devices and services that offer a meaningful improvement in patient care to the health care community.
The AVL Single Use The GlideScope AVL Single Use defines advanced video laryngoscopy—with airway views in DVD clarity, and real-time recording to capture the details of difficult airway cases. With six single-use Stat options for patients from preterm to morbidly obese, the AVL Single Use has been enhanced with technological improvements designed to help users get the view they need to place a tube quickly. For example, the AVL Single Use 3-4 has a new Reveal™ anti-fog feature, with a rapid heating profile to resist lens fogging. The AVL also offers a digital color monitor, featuring a unique onboard 4-Step Technique video tutorial that describes and illustrates tips for successful GlideScope intubation. Another advanced element of the AVL Single Use is its integrated, real-time recording capability. These high-quality digital files of intubations are downloadable and viewable on a personal computer. The recordings can be valuable for teaching and helping to confirm tube placement. As part of the AVL family, the reusable GlideScope Direct intubation trainer combines the characteristics of a standard Macintosh blade with AVL video technology to facilitate instruction of classic direct laryngoscopy (DL).
AT A GLANCE
GlideScope AVL Single Use GlideScope AVL Reusable BladderScan BVI 9400
FOUNDER AND CEO Gerald McMorrow
The GlideScope AVL Reusable
BladderScan Bladder Volume Instruments From the makers of GlideScope instruments, BladderScan® bladder volume instruments are portable, three-dimensional ultrasound devices that quickly, accurately and noninvasively measure urinary bladder and post-void residual volume. BladderScan instruments help diagnose and monitor postoperative urinary retention—POUR—and improve patient outcomes by reducing the duration of urinary catheterization, or avoiding it altogether.1 Designed to be used by physicians or nurses, the instruments are easy to use, learn and teach. No sonographer required.
Used in acute care, primary care, urology and extended care settings, the BladderScan BVI 9000 series instruments, with NeuralHarmonics® technology, feature accelerated speed and sharpened accuracy in bladder volume measurement. Each BVI 9000 series instrument, in addition to providing distinct modes for measuring bladder volume in adults, offers a unique capability tailored to the needs of specific patient groups. The BladderScan BVI 9400 offers a Small Child mode for patients weighing as little as 6.8 kg. The BladderScan BVI 9600, tailored for emergency departments, offers both bladder volume measurement and AortaScan® mode to noninvasively measure the diameter of the abdominal aorta. This may help physicians identify the presence of abdominal aortic aneurysms (AAA). The AortaScan AMI 9700 instrument also is available to help physicians assess for AAA.
Verathon Products Support Improved Patient Care Across a spectrum of patients—from newborns to the elderly—health care providers need medical devices that are proven, practical and reliable. Verathon instruments can support an evidence-based approach to care, to help evaluate, diagnose and manage an array of patients. GlideScope, BladderScan and AortaScan instruments are designed to help manage cases in a wide range of clinical settings—from prehospital to acute care to extended care and more.
GlideScope AVL Single Use
The AVL Reusable
42
The GlideScope AVL Reusable delivers the digital video technology and optimized functionality physicians expect from advanced video laryngoscopy—now in four reusable blade sizes for patients from infant to the morbidly obese. When users need to get a tube placed quickly, the AVL Reusable provides a consistently clear view, with Reveal anti-fog technology, enabling fast intubation.
Anesthesiology News • August 2012
BladderScan BVI 9400
1. Moore DA, Edwards K. Using a portable bladder scan to reduce the incidence of nosocomial urinary tract infections. Medsurg Nursing 1997;6:39-43. GlideScope, the GlideScope symbol, GVL, Reveal, Verathon and the Verathon Torch symbol are trademarks of Verathon Inc.
This corporate profile was reviewed and approved by Verathon Medical.
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AnesthesiologyNews.com I 45
PR N FUJII
CONTINUED FROM PAGE 16
That deadline has passed without word from the schools. The Fujii scandal marks the biggest and most recent, but hardly the first, major misconduct probe involving anesthesiologists. In 2009, Scott Reuben, MD, then of Baystate Medical Center in Massachusetts, was found to have fabricated data and misused grant money—fraud for which he spent six months in federal prison. That was followed by news that Joachim Boldt, MD, PhD, a leading German critical care specialist, had failed to obtain ethics approval in scores of studies, nearly 90 of which have been retracted. Dr. Boldt also appears to have fabricated findings in at least one paper, which A&A retracted in 2010. In fact, of the 2,200 papers that journals have retracted since 1970, Drs. Reuben, Boldt and Fujii—assuming the 172 articles found to be
fraudulent are pulled—account for roughly 285, or nearly 13%. Anesthesiologists “have an absolutely horrifying track record in terms of retractions,” said R. Grant Steen, PhD, a researcher who studies publishing ethics. “I really wonder whether anesthesiologists aren’t feeling like the ground is shifting underneath them.” Dr. Steen has been considering a formal study of whether anesthesiology is more vulnerable to fraudulent research, but has not yet launched such an analysis. One possibility, he said, is that anesthesiologists who conduct randomized controlled trials may have less oversight than other specialists, such as cardiologists or neurologists. If so, those who want to fabricate their results would have an easier time doing so, he said. But Daniel Sessler, MD, chair of the Department of Outcomes Research at Cleveland Clinic, in Ohio, said he doubted that anesthesiology was more
prone to fraud than other medical specialties. “What this reminds me of is cancer clusters,” Dr. Sessler said. “If you look around, it’s very easy to find clusters of rare cancers, but it’s always just a statistical fluke. I would assume that this is the same. It’s just a period of bad luck for anesthesia.” That’s not to say that research fraud is not a problem, added Dr. Sessler, who with a colleague has written a paper for A&A on ways to prevent misconduct in clinical studies. These steps include using Web-based systems for randomizing patients into trials, ensuring that a research committee reviews any manuscript from faculty prior to submission and other measures to avoid concentrating too much authority in one scientist. Although cases like those of Drs. Fujii, Boldt and Reuben are dramatic and concerning, Dr. Sessler said they are dwarfed by a more insidious
problem with clinical research. “I’m more concerned in a broad sense with what you might call minor misconduct rather than wholesale fabrication,” Dr. Sessler said. “For example, I suspect that there are many studies where blinding is not absolutely maintained, where results are informally evaluated between formal interim analyses, there is a degree of data selection, or the primary outcome and hypotheses are not specified in advance. While less serious than outright fabrication, these compromises nonetheless degrade the integrity of research. Furthermore, they are almost surely more common than fabrication and probably contribute more to scientific error.” Efforts to prevent such abuses are particularly important as research becomes more international and collaborative, Dr. Sessler said. —Adam Marcus
Opioid-Related Problems Up Costs, Prolong Hospital Stays
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urgical patients who experience side effects from opioids stay in the hospital longer and cost more to treat than those who do not experience such events, a new study has found. The study is the first to quantify the costs of complications from opioids, according to the researchers. The retrospective analysis of 45,342 patients found that opioid-related adverse events increased costs from an average of $17,281 to $18,309, or more than $1,000 per patient. Patients who experienced side effects stayed in the hospital for an average of 5.2 days, roughly a full day longer than the 4.1 days for those who did not have adverse events (P<0.0001), the researchers found. The researchers presented their findings at the 2012 annual meeting of the International Anesthesia Research Society (abstract S-366). “Opioid-related adverse events are common,” said Gan, MD, MHS, vice chair of study leader Tong-Joo anesthesiology at Duke University School of Medicine, in Durham, N.C. “We often underestimate the incidence, severity and added health care costs from these adverse events.” Dr. Gan and his colleagues queried the Premier database for selected inpatient surgeries: open colectomy, laparoscopic colectomy and cholecystectomy, total abdominal hysterectomy and hip replacement. The study included inpatients over the age of 18 years for the period between 2008 and 2010. Adverse events were defined using ICD-9 diagnosis codes. The incidence of opioid-related adverse events was 19.4%. Length of stay and cost outliers were defined as being at least one standard deviation above mean values. The 45,342 patients who had experienced adverse events were matched to 135,941 patients without
complications for age, severity of illness and sex. If the study is yet another call for finding an alterDescriptive statistics and regression analysis were native to opioids, “nobody would argue with that,” he used to assess the outcomes of length of stay and said. “How do you do that? That’s the challenge.” total cost. In addition to the differences in costs, patients who —Tinker Ready experienced side effects accounted for a larger share of the outliers for prolonged length of stay (8.3% vs. Advertisement 5.3%) and total cost (13.0% vs. 5.3%). “Ample evidence suggests that using non-opioid NEW PRODUCT adjuncts not only improves pain management but reduces opioid side effects and potentially reduces health care costs,” Dr. Gan said. Dr. Gan has received research funding and speaking fees from Pacira, which is developing non-opioid analgesics for postsurgical pain. Anesthesiologists are aware of the costs of opioidrelated adverse events, said Frank J. Overdyk, MD, professor of anesthesiology at Hofstra University School of Medicine, in Hempstead, N.Y., and director of research for North American Partners in Anesthesia. This preliminary study suggests hidden costs, he said. ULTRAPORT™ zer0 The researchers’ methods may impact the validThe first closed system stopcock with zero dead ity of this report, because billing codes may not be space. specific enough to identify cases of opioid toxicity, ULTRAPORT zer0 is a unique stopcock designed to Dr. Overdykk said. reduce the chance of CRBSIs and to simplify IV adminThis study comes at a time when physicians and istrations by automatically priming & flushing. Also, nurses are under pressure to be more aggressive with the swabbable closed system eliminates caps and pain therapy, he said. Value-based purchasing includes avoids leaks if the handle is inadvertently left open. patient satisfaction, and pain control is a part of qualVisit our Web site to download a brochure and video ity of care. The result may be more opioid-related at www.AnesthesiaIV.com, or to schedule a demo adverse events as patients are older and more meditoday to learn more, call (800) 227-2862. cally complex, and there are few pharmacologic alter824 Twelfth Ave. Bethlehem, PA 18018 natives to opiates for postoperative pain, Dr. Overdyk Phone: (800) 227-2862 www.bbraunusa.com said. Opioid-sparingg techniques such as regional anesthesia play a role but are time-consuming.
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P A IN M E D I C I NE
Spinal Cord Monitoring During Surgery May Prevent Paralysis
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he American Academy of Neurology has issued an updated guideline that recommends monitoring the spinal cord during spinal surgery to help prevent paralysis or loss of muscle function. The guideline also applies to chest surgeries, such as procedures to repair narrowing of the walls of the aorta. The update was published jointly in
Neurology (2012;78:585-589) and the Journal of Clinical Neurophysiology (2012;29:101-108). “These guidelines will encourage surgeons and hospitals to monitor when they may not have done so in the past,” said lead author Marc R. Nuwer, MD, PhD, chief of clinical neurophysiology at the University of California, Los Angeles. “It’s time to get on board.
Monitoring is cost effective and provides a better outcome to patients.” Multiple studies have shown that such intraoperative monitoring, which detects small changes in nerve signal transmission, can alert the surgeon in time to be able to find and address problems before damage occurs. To determine whether monitoring the spinal cord with somatosensory
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and transcranial electrical motorevoked potentials predicted poor surgical outcomes, a panel of experts reviewed the results of a comprehensive literature search of relevant published studies on intraoperative monitoring. The researchers found that the 12 studies that met the inclusion criteria consistently showed no paraparesis, paraplegia and quadriplegia in patients who had no changes in evoked potential when monitored during spinal cord surgery. The studies did show paraparesis, paraplegia and quadriplegia in patients with such changes. “If, by monitoring, the surgeon knows there are nerve signal transmission changes, they can look for bleeding nearby the spinal cord, release the amount of traction on the spinal cord, change the patient’s position or raise their blood pressure as needed,” said Dr. Nuwer. “There are a dozen things you can easily do if you know the spinal cord is at risk for being injured.” Monitoring also may benefit patients by reassuring physicians that surgery is going well, allowing them to perform a more complete procedure. “During surgery, you’re always thinking in the back of your head: ‘I hope the spinal cord is OK.’ If there’s no monitoring, out of an abundance of caution you may only take the procedure to a certain point,” said Dr. Nuwer. “But if you know everything is going fine, you can perform a more complete surgery.” Monitoring, already commonplace at many institutions, is expected to become more widely available as a result of the guideline update. “This guideline will make a big difference,” said Mario De Pinto, MD, assistant professor of anesthesiology and pain medicine at the University of Washington, and director of Pain Relief Service at Harborview Medical Center, in Seattle. “These days, you need to have this type of monitoring for more than just complex surgical procedures. Spinal cord damage is a possibility even with simple surgeries.” Dr. Nuwer agreed: “Now that monitoring is a guideline, it means that you better have a good excuse not to do it,” he said. “Either it wasn’t necessary, wasn’t available, or the patient was a bad candidate. Not every case needs monitoring. But if you can reasonably do it, you should.” —Dana Hawkins-Simons
AUGUST 2012
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PA IN M E D ICIN E
RF Ablation Provides Durable Relief of Sacroiliac Joint Pain
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of Anesthesiology at Advocate Illinois Masonic Medical Center in Chicago, added, “It would be helpful to stratify the patients’ level off pain from mild to extreme, ratheer than using a 50% cutoff point.” In response, Dr. Chengg said that he used the 50% pain relief cutoff point because it’s a criterion commonly
used in published data and in clinical practice by physicians to select patients foor RFA. Dr. Chengg said the resuults could affect the daily practice of pain management. “This is an important study for patients suffering
from SIJ pain,” he said. “When RFA is denied because of a less than 50% pain reduction after SIJ steroid injection, there are no other good options for pain control. Many patients end up taking opioid medications, and as we know, that can create a whole new set of problems.” —Dana Hawkins-Simons
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adiofrequency ablation (RFA) of the lateral branches reduced pain in patients with sacroiliac joint (SIJ) pain, regardless of the extent of relief achieved after intraarticular steroid injections, according to a new study presented at the 2012 American Academy of Pain Medicine’s annual meeting in Palm Springs, Calif. (poster 136). “The pain relief many patients get from an intra-articular steroid injection is short-lived,” said lead researcher, Jianguo Cheng, MD, PhD, professor of anesthesiology and program director of the Pain Medicine Fellowship Program at the Cleveland Clinic. “The degree of pain relief [from intraarticular steroid injections]—usually at least a 50% reduction—is often used to select patients for RFA of the lateral branches. However, the validity of this criterion had not been tested.” To determine whether the degree of pain relief after SIJ steroid injection was predictive of the duration of pain relief after RFA of the lateral branches, the investigators retrospectively looked at 80 patients who had RFA after SIJ steroid injection, which consisted of 2 mL 1% lidocaine and 40 mg of triamcinolone. Researchers split the patients into two groups: 60 patients who had more than 50% pain relief from the injection and 20 patients who reported 25% to 49% pain relief. Both groups responded to RFA with nearly identical outcomes: About half of the patients in each group experienced greater than 50% pain reduction for three to six months. After adjusting for variables such as age, modes of pain onset and multiple pain complaints, researchers found no significant difference in the duration of post-RFA pain relief between the two groups (hazard ratio, 0.96; 95% confidence interval, 0.49-1.90; P=0.91). “Our study shows that many patients who don’t report greater than 50% pain reduction with SIJ steroid injection can get that relief after RFA treatment,” said Dr. Cheng. “Their reaction to the injection doesn’t predict their reaction to RFA.” Kenneth D. Candido, MD, who was not involved in the study, noted, “While the information appears compelling, further refinement of the statistical methodology would be extremely useful to enhance its clinical applicability.” Dr. Candido, chairman and professor of the Department
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Methylnaltrexone Relieves Opioid-induced Constipation
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irtually all the data on methylnaltrexone (Relistor, Progenics Pharmaceuticals Inc.) seem to confirm the drug can bring fast, effective and relatively side effect–free relief to patients suffering from opioidinduced constipation. The potential significant adverse events are gastrointestinal (GI) perforation and abdominal pain, but these do not appear to be
a large concern. The subcutaneous form of methylnaltrexone, an opioid antagonist, was approved by the FDA in April 2008 for add-on therapy for patients receiving palliative care for advanced illnesses and those who have opioidinduced constipation but have not responded sufficiently to laxatives. Salix Pharmaceuticals is now seeking
an indication for patients with nonmalignant pain based on data from 2011, and is conducting Phase III trials of oral methylnaltrexone. The 2008 approval was based largely on two randomized, placebo-controlled studies funded by Progenics Pharmaceuticals, one of which was later published in The New England Journal of M 2008;358:2332-2343). Medicinee (NEJM
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The results demonstrated that 48% and 52% of patients, respectively, treated with one or two to four daily injections of methylnaltrexone had a rescuefree bowel movement (RFBM) within four hours. The rates for patients receiving placebo were 15% and 8%, respectively (P<0.001, for both comparisons). Moreover, the median time to laxation was significantly shorter in patients receiving methylnaltrexone compared with placebo. Results of a recent randomized controlled trial indicate that approximately 30% of injections of subcutaneous methylnaltrexone in patients with chronic, noncancer pain and opioidinducedd constipation treated once a day or once every other day had an RFBM within four hours of treatment (J ( Pain 2011;12:554-562). The four-weekk trial involved 150 patients randomized to 12 mg of subcutaneous methylnaltrexone daily, another 148 randomized to 12 mg of subcutaneous methylnaltrexone every other day and 162 given daily placebo injections. The results indicate the medication is effective and also safe, although the patients in the methylnaltrexone groups had more abdominal pain, nausea, diarrhea and hyperhidrosis than did the placebo subjects. A post hoc analysis of the trial published three months later showed that 42.3% of patients responded to at least two of the first four daily treatments, and those patients averaged 4.8 RFBMs—that is, laxation without the use of a rescue laxative—per week compared with two RFBMs per week among the other 57.7% of subjects (Pain Medd 2011;12:1223-1230). Both analyses were funded by Progenics. Edward Michna, MD, director of the Pain Trials Center at Harvard Medical School, in Boston, led both studies. He said his group uses methylnaltrexone primarily in cancer patients who have been admitted to the hospital for severe constipation, and one or two doses are often all that’s required to “get them moving.” “Progenics asked for the post hoc analysis because they wanted to find out which patients have the highest chance of success, since it’s an expensive medication,” Dr. Michnaa said “Our results show that if a patient responds early on, it’s a good sign that they’re going to continue responding.” Another Progenics-supported study, published in February 2011 (Expert Opin Drug Metab Toxicoll 2011; 7:
AUGUST 2012
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PA IN M E D ICIN E 227-235), confirmed that when methylnaltrexone is administered subcutaneously it has a high bioavailability at therapeutic dose levels. It also has a terf life of eight to nine hours, is minal halfmetabolized only to a limited extent before being excreted and has a limited number of drug–drug interactions. “The onset of activity is fairly quick, f life is short—in and the practical halffact, the clinically relevant halff life is only two to three hours because the concentration drops so quickly after that,” confirmed Robert Israel, MD, senior vice president of medical affairs, Progenics, in Tarrytown, N.Y., and senior author of the NEJM paper. “That means that you don’t get accumulation if you give it according to the instructions on the label, and you can give it as often as daily.” Methylnaltrexone, however, is contraindicated in patients with known or suspected mechanical GI obstruction. In 2010, the FDA issued a warning on methylnaltrexone because cases of GI perforation were reported in patients with complex confounding factors who received methylnaltrexone—such as cancer, GI malignancy, GI ulcer, and Ogilvie’s syndrome—and medications such as bevacizumab (Avastin, Genentech), nonsteroidal anti-inflammatory drugs and steroids. The FDA stated that physicians should use methylnaltrexone with caution in patients with known or suspected lesions of the GI tract, and that patients who develop severe, persistent and/or worsening abdominal symptoms should be advised to discontinue therapy and immediately notify their physicians. In a letter to the editor of the Journal of Opioid Management, Xiulu Ruan, MD, director of clinical research at Physicians’ Pain Specialists of Alabama, PC, in Mobile, cited a study that showed another peripherally restricted opioid antagonist, naloxone methiodide, “when administered subcutaneously, blocked the antinociception of systemically and centrally administered methadone” (J ( Pain 2009;10:369-379). Methadone is dependent on peripheral opioid receptors, and Dr. Ruan contends that these data strongly support the argument that peripheral opioid receptors also may play an important role in antinociception. “From an evolutionary standpoint, it seems more conceivable that the plethora of opioid receptor types expressed in the gut serve not only to modulate motility of the smooth muscles of the bowel, but also to participate in antinociception,” Dr. Ruan said. “I wonder what the outcome would be when
patients on methadone for analgesia were given methylnaltrexone and alvimopan.” Douglas Drossman, MD, co-director of the Center for Functional GI & Mobility Disorders at the University of North Carolina Health Care System, in Chapel Hill, said Dr. Ruan’s explanation is plausible, especially based on related research he is conducting on narcotic bowel syndrome (Clin Gastroenterol Hepatol 2007;5:1126-1139). This condition leads to abdominal
pain from narcotics, which activates glial cells and upregulates pain. However, Dr. Drossman noted, he has not seen abdominal pain develop de novo in any patients he has treated with methylnaltrexone, and that he has found it to be quite effective, “although I am cautious when using it in patients who have predominant abdominal pain with their constipation. “For opioid-induced constipation, methylnaltrexone’s almost like a diagnostic test, because if patients present
with constipation as their gastrointestinal disorder and also are put on narcotics for something else, I may not know if the constipation is related to the narcotics or not. But if they respond to methylnaltrexone, then it’s likely narcotic-related,” Dr. Drossman said. The FDA is expected to make a decision by July 27 on the application for chronic nonmalignant pain, Dr. Israel said. —Rosemary Frei, MSc
50
CONTINUING MEDICAL EDUCATION
This lesson is available online at www.mssm.procampus.net
AUGUST 2012
Lesson 299: PreAnesthetic Assessment of the Patient With Acute Ischemic Stroke WRITTEN BY:
LEARNING OBJECTIVES
Alan D. Kaye, MD, PhD Professor and Chairman, Department of Anesthesiology, Louisiana State University Health Science Center, New Orleans, Louisiana
At the end of this activity, the participant should be able to: 1. Summarize anesthetic problems presented by patients with acute ischemic stroke. 2. Describe the clinical presentation of a patient with acute ischemic stroke. 3. Apply appropriate preoperative testing and evaluation. 4. List proper monitoring of the patient. 5. Plan methods to maintain hemodynamic control perioperatively. 6. Outline the different treatment modalities available for stroke. 7. Present an anesthetic and analgesic plan for a patient undergoing a carotid endarterectomy (CEA). 8. List associated complications of acute ischemic stroke. 9. Anticipate, recognize, and manage likely postoperative complications following CEA. 10. Understand standard anesthetic techniques for CEA.
M. Florencia Lasala, MD Resident, University of Texas Southwestern School of Medicine, Department of Anesthesiology, Dallas, Texas Amir Baluch, MD Attending Staff Physician, Metropolitan Anesthesia Consultants, Dallas, Texas
REVIEWED BY: Lionel Branch, MD Department of Neurology, Louisiana State University School of Medicine, New Orleans, Louisiana
DISCLOSURES The authors have no relationships with pharmaceutical companies or products to disclose, nor do they discuss off-label or investigative products in this lesson.
PROFESSIONAL GAPS Evidence-based medicine has changed the management of acute stroke in recent years. Several major trials have been completed. Knowledge of the findings and recommendations is important to providing appropriate anesthetic care.
TARGET AUDIENCE Anesthesiologists
CALL FOR WRITERS If you would like to write a CME lesson for Anesthesiology News, please send an email to Elizabeth A.M. Frost, MD, at ElzFrost@aol.com.
CASE HISTORY A 68-year-old man presented to the emergency room complaining of sudden onset of right face and arm weakness and dysphasia for the past 3 hours. Three months previously, he experienced temporary weakness in the right arm that resolved spontaneously after about 30 minutes. The patient called his physician at that time and was told to make an appointment for medical evaluation. Family events prevented him from following through and, moreover, he felt well. The patient denied any loss of consciousness, headache, falls, or trauma to the head. Further questioning revealed a 30-pack per year history of smoking and long-standing hypertension for which he took amlodipine and diltiazem, although he admitted to occasionally forgetting to take the medications. Physical examination revealed a normal cephalic head; a brisk bruit was heard over the left carotid artery and a systolic crescendo-decrescendo murmur identified best at the right sternal border. Atrial fibrillation with a ventricular response rate of 90 was identified. Strength against resistance was decreased in the right arm and leg compared with the left along with hyperreflexia. The patient was admitted and neurologic consultation sought. Orders were placed for bilateral ultrasound examination of the carotid arteries and non-contrast computed tomography (CT) scan of the head. Significant plaque occluding more than 90% of the left internal carotid artery was demonstrated. Vital signs included blood pressure (BP) of 165/90 mm Hg. Blood sugar was 167 mg/dL. The patient was started on an aspirin regimen and oral antihyperglycemic agents. His BP medications were reviewed and metoprolol and simvastatin were added. The deficit improved significantly over the next 7 days. After options and risks were discussed, the patient was scheduled for a carotid endarterectomy (CEA) 2 weeks after the stroke.
Preanesthetic Considerations for Stroke
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erebrovascular disorders may be classified as either ischemic (80%) or hemorrhagic (20%) and are typically characterized by a sudden loss of neurologic function. Ischemic stroke can be due to thrombosis, embolism, or either systemic hypo- or hypertension, whereas hemorrhagic stroke is due to subarachnoid or intracerebral hemorrhage. A transient ischemic attack (TIA) is a brief neurologic dysfunction that persists for less than 24 hours.
PREANESTHETIC ASSESSMENT Dr. Elizabeth A.M. Frost, who is the editor of this continuing medical education series, is clinical professor of anesthesiology at the Mount Sinai School of Medicine in New York City. She is the author off Clinical Anesthesia in Neurosurgery (Butterworth-Heinemann, Boston) and numerous articles. Dr. Frost is past president of the Anesthesia History Association and former editor of the journal of the New York State Society of Anesthesiologists, Sphere. She is also editor of the book series based on this CME program, Preanesthetic Assessment, Volumes 1 through 3 (Birkhäuser, Boston) and 4 through 6 (McMahon Publishing, New York City).
A COURSE OF STUDY FOR AMA/PRA CATEGORY 1 CREDIT Read this article, reflect on the information presented, then go online (www.mssm.procampus.net) and complete the lesson posttest and course evaluation before August 31, 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: August 1, 2012 TERMINATION DATE: July 31, 2013 ACCREDITATION STATEMENT The Mount Sinai School of Medicine is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.
CREDIT DESIGNATION STATEMENT The Mount Sinai School of Medicine designates this enduring material for a maximum of 2.0 AMA PRA Category 1 Credits.â&#x201E;˘ Physicians should claim only the 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, transparency, and scientific rigor in all CME-sponsored educational activities. All faculty participating in the planning or implementation of a sponsored activity are expected to disclose to the audience any relevant financial relationships and to assist in resolving any conflict of interest that may arise from the relationship. Presenters must also make a meaningful disclosure to the audience of their discussions of unlabeled or unapproved drugs or devices. This information will be available as part of the course material.
CONTINUING MEDICAL EDUCATION
AUGUST 2012
Stroke is the leading cause of disability and the third leading cause of death in the United States behind heart disease and cancer.1 Approximately 795,000 people suffer a stroke annually; 600,000 of these are first attacks. Approximately 75% of all strokes occur in people over the age of 65 years. The incidence of stroke in men is greater than in women until age 85. The maleâ&#x20AC;&#x201C;female incidence ratio is 1.25 at ages 55 to 64; 1.50 for ages 65 to 74; 1.07 at 75 to 84; and 0.76 at 85 and older.1 The data may reflect smoking incidence, hormonal changes, and/or sex-associated life span. Strokes in the elderly are more severe and debilitating, necessitating long-term care and institutionalization. Because most victims survive, the number disabled secondary to a cerebrovascular accident is expected to increase substantially as people live longer.
Causes Acute ischemic stroke can result from thrombosis, embolism, or systemic hypoperfusion. Thrombosis generally refers to local in situ obstruction of an artery. Thrombosis can be further divided into small and large vessel disease. Large vessel disease commonly refers to disease of the common and internal carotids, vertebral arteries, the circle of Willis, and proximal branches. The obstruction may be caused by disease in the arterial wall, such as arteriosclerosis, dissection, or fibromuscular dysplasia. In smaller vessels, obstruction usually is the result of lipohyalinosis, which is characterized by vessel wall thickening and reduction in luminar diameter. A stroke resulting from an occlusion of a branch arising from large arteries of the circle of Willis, middle cerebral, or basilar artery is referred to as a lacunar stroke. Embolism refers to particles, usually blood clots originating elsewhere that block arterial access to a particular brain region. Cardioembolism sources include atrial fibrillation, ventricular akinesis following myocardial infarction (MI), valvular heart disease, and dilated cardiomyopathy. Total body or systemic hypoperfusion refers to globally reduced blood flow that can be the result of cardiac pump failure, reduced cardiac output, pulmonary embolism, pericardial effusion, decreased perfusion from lactic acidosis, or bleeding. Local injury can occur from cerebral vasodilation during reperfusion.
Risk Factors Identification of risk factors for ischemic stroke should facilitate stroke prevention and guide treatment. The prime risk factor, hypertension, which affects 72 million North Americans, increases stroke incidence, correlating directly with higher BP.2 Most patients with ischemic stroke or TIA have a history of hypertension and are treated for BP reduction.2 Although the exact relationship between blood lipids and stroke is evolving, elevated total cholesterol or low-density lipoprotein (LDL) cholesterol levels link directly with an increased risk for ischemic stroke and large artery atherosclerotic stroke.2 Autopsy examinations have revealed that atherosclerosis of carotid arteries and other arteries of the circle of Willis relates directly to blood levels of LDL. When LDL levels are elevated, lipoprotein traverses the vascular endothelium through mainly receptor-independent mechanisms and accumulates within the intima. Arteries with enlarging intimal plaques compensate initially by increasing
Table 1. The Ischemic Cascade Blood flow ceases
for ischemic stroke, 0.80.6 The meta-regression analysis revealed a significant nonlinear relationship between alcohol consumption and total and ischemic stroke.
Cellular production of excessive glutamate
Prevention
Anerobic respiration produces lactic acid
Based on data from numerous clinical trials, stroke can be prevented by modifying risk factors.7 These alterations include controlling hypertension, smoking cessation, anticoagulation in atrial fibrillation, increasing physical activity, weight reduction, controlling blood lipid levels, lowering elevated plasma homocysteine levels, and regulating blood sugar levels in diabetics. Surgical treatment of carotid artery stenosis via CEA reduces the risk for stroke. Three studies, the ECST (European Carotid Surgery Trial), the NASCET (North American Symptomatic Carotid Endarterectomy Trial), and the Veterans Affairs CSP (Cooperative Study Program) all showed outcomes supporting CEA with moderate-term follow-up. Symptomatic patients included those with greater than 70% ipsilateral carotid stenosis and TIAs, transient monocular blindness, or nondisabling stroke.2 As a result of these landmark studies, most surgeons perform endarterectomy in a symptomatic patient with carotid stenosis of 70% or greater and an asymptomatic patient with 80% or greater stenosis. Duplex ultrasound and transcranial Doppler studies have shown evidence that carotid artery stenosis of 70% to 75% represents the point at which a pressure drop across the stenosis is likely to occur. Other techniques, including carotid artery angioplasty and stenting, may be therapeutic options for certain patients. However, the SAMMPRIS (Stenting and Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis) trial was halted in April 2011 when a higher rate of adverse events in the angioplasty/stenting arm was identified.8
Damaging free radicals formed Cellular filling with electrolytes and swelling Cellular death
the lumen diameter. However, the plaque may enlarge enough to cause obstruction. Many acute stroke patients have recognized that disorders of glucose metabolism and diabetes worsen the outcome after an acute incident. An oral glucose tolerance test is recommended in all stroke patients with no prior history of diabetes. Diabetes is a proven risk factor for stroke with a 2- to 3-fold increased risk for patients with diabetes compared with those without the disease. Recently, a prospective cohort study showed an increased risk for ischemic stroke or TIA in patients with metabolic syndrome, defined as obesity and any two of the following: elevated triglycerides, reduced high-density lipoproteins (HDL), elevated BP, and/or elevated fasting plasma glucose.3 Another study showed insulin resistance to be independently associated with the risk for stroke even if adjusted for glycemic control.4 Early recognition of glucose metabolism disorders in stroke patients is crucial because hyperglycemia during the acute phase worsens outcome by reducing the salvage of penumbral tissue mediated by high lactate levels in brain tissue.5 Cardiac disease is an important precursor to stroke. Coronary artery disease (CAD) can be the cause of ischemic stroke by a number of mechanisms: 1. It provides a source of embolism from the heart. 2. It is commonly associated with other risk factors. 3. Medical and surgical treatments of CAD may create a predisposition. 4. Pump failure may increase the risk. Patients with intermittent atrial fibrillation are at the greatest risk for embolism. Hypertension causes left ventricular hypertrophy and predisposes to stroke. Other factors associated with a higher incidence of CAD and stroke include elevated plasma levels of homocysteine and fibrinogen. Obesity predisposes individuals to stroke by virtue of hypertension, hyperglycemia, and hyperlipidemia. Cigarette smoking and secondhand smoke are further risk factors. Nicotine, carbon monoxide, free radicals, and cytokines cause the buildup of atherosclerotic plaque, in part due to recurrent episodes of hypoxia, leading to decreased blood flow and ischemia.2 By altering clotting factors that favor thrombogenesis, oral contraceptives increase susceptibility to thrombotic disease. Chronic alcoholism and heavy drinking are risk factors for all subtypes of stroke.2 However, minimal alcohol consumption of 2 or fewer drinks per day may be protective. According to Reynolds, binge drinking, defined as 60 g alcohol (men) and 40 g alcohol (women) in a period of 2 hours, was associated with an increased relative risk for ischemic stroke of 1.69, whereas consumption of less than 12 g per day was associated with a reduced relative risk
Pathophysiology of Cerebral Ischemia Cerebral blood flow (CBF) averages 40 mL/100 g of brain tissue per minute. When CBF falls to approximately 20 mL/100 g of brain tissue per minute, electroencephalogram (EEG) evidence of ischemia begins to appear. At a CBF level of approximately 15 mL/100 g of brain tissue per minute, cortical EEG becomes isoelectric and when it is reduced to 6 mL/100 g of brain tissue per minute, irreversible damage occurs. The core of the ischemic area receives insufficient blood flow to maintain energy metabolism and, consequently, dies within minutes without intervention. Between the area of core ischemia and region of normal perfusion, an area receiving intermediate blood flow, the ischemic penumbra, exists. Blood supply is reduced to a level that interrupts neuronal function; however, adenosine triphosphate levels are maintained around typical levels. Nevertheless, if blood supply is not restored, an ischemic cascade results in additional, delayed damage to brain cells (Table 1).
Diagnosis and Examination If stroke is suspected, prompt, accurate diagnosis and treatment are essential to minimize brain tissue damage. Diagnosis includes a medical history and a physical examination to evaluate the level of consciousness, sensation, and motor function, and to determine the cause, location, and extent of the stroke.
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This lesson is available online at www.mssm.procampus.net
Table 2. Signs and Symptoms of Stroke Difficulty speaking or understanding speech (aphasia)
AUGUST 2012
Table 3. Modalities of Cerebral Protection Physiologic
Recommendation
Hypothermia
Routine hypothermia is not recommended due to the possibility of increased myocardial oxygen consumption if patient shivers.
Dizziness or lightheadedness (vertigo)
Hyperglycemia
Treat by eliminating glucose-containing IV solutions and giving small doses of insulin.
Numbness, paralysis, or weakness, usually on one side of the body
Hypertension
Maintain normal to high arterial pressure in most situations.
Hemodilution
Optimal hematcrit during cerebral ischemia is approximately 30%.
Carbon dioxide
Normocarbia
Difficulty walking
Seizure (relatively rare) Severe headache with no known cause Sudden confusion Sudden difficulty walking, dizziness, loss of balance or coordination Vomiting
Symptoms of stroke depend on the type and location. Signs of hemorrhagic stroke occur gradually, whereas signs of ischemic stroke usually have a more sudden onset (Table 2).9 The medical history should be directed at identifying risk factors. Time of onset needs to be established from family, friends, or witnesses to determine whether or not thrombolytic therapy is an option. Documentation of vital signs is followed by basic laboratory blood testing and imaging studies (non-contrast CT scan, magnetic resonance imaging, ultrasound).
Medical Management Medical management of the acute ischemic stroke patient begins with controlling respiratory function, which entails managing airway, oxygenation, and ventilation.9 Although in most patients oxygen supplementation is adequate, tracheal intubation may be needed if the patient is unable to protect his or her lungs from aspiration. It should be noted that vomiting is very common as intracranial pressure (ICP) increases. Furthermore, the physician must maintain the patient’s baseline body temperature (37°C-38°C), hemodynamic stability, and blood glucose, and when appropriate, consider anticoagulant therapy (Table 3).9 Based on animal data, hypothermia decreases both basal and electrical metabolic requirements throughout the brain. However, because there are few human studies evaluating the effectiveness of hypothermia in an acute stroke, it continues to be controversial. Systemic hypertension is common at initial stroke presentation. Rapid lowering of BP can decrease CBF and worsen the ischemic injury. Following stroke, patients may become very sensitive to hypotensive medication. Monitoring with direct arterial cannulation or very frequent noninvasive means is necessary. Even small doses of labetalol, for example, can cause an almost catastrophic fall in BP. If possible, BP should be lowered slowly over a 24-hour period (15%) at which point it often will stabilize spontaneously. Hyperglycemia appears to be associated with a poor outcome in ischemic stroke patients because glucose is metabolized to lactic acid resulting in acidosis and increased neuronal injury. Prophylaxis against deep vein thrombosis is most commonly
attained by giving 5,000 units of heparin subcutaneously every 12 hours. Signs of increased ICP (vomiting, cardiac irregularities, neurologic, and papillary) as cerebral edema worsen the clinical course.15 Aspirin is recommended for both initial therapy of acute stroke and for prevention of recurrent strokes. IV recombinant tissue plasminogen activator may be used if treatment can be started within 4.5 hours of symptom onset.10 Direct infusion of thrombolytic agents (prourokinase) through micro catheters directly at the site of occlusion offers several benefits. First, there is less risk for systemic bleeding because the use of intra-arterial thrombolysis allows physicians to deliver the thrombolytic directly to the affected vessel in a lower dose than with IV therapy. Furthermore, this approach allows a large dose of concentrated agent to be directly delivered to the thrombus. Finally, intra-arterial thrombolysis can be combined with methods of mechanical disruption.10 Clinical trials have demonstrated that the time window may be longer than previously thought for intra-arterial thrombolysis.11 Many patients, unfortunately, have lingering neurologic deficiencies despite these treatments. The initial amount of neurologic dysfunction and early evidence of recovery in acute stroke are 2 powerful predictors of outcome. Thrombolytic agents are contraindicated in patients with severe sustained hypertension.12 Other therapies include early evacuation of the clot, decompressive craniectomy, neuroprotective agents such as calcium channel blockers, citicoline, γ-aminobutyric γ acid agonists, glycine antagonists, lubeluzole, and N-methyl-D-aspartate antagonists.13 Systemic anticoagulation includes heparinoids, specific thrombin inhibitors, low-molecular-weight heparin, oral anticoagulants, unfractionated heparin, as well as thrombolysis mentioned above.13 Magnesium has been studied as a neuroprotective agent in many settings.14 Although magnesium has been shown to be protective in animal studies, results of the IMAGES (Intravenous Magnesium Efficacy in Stroke) trial in humans following acute ischemic stroke were largely disappointing, perhaps because the therapy was not combined with post-ischemic hypothermia.15
Preoperative Anesthesia Evaluation The preoperative anesthesia evaluation should involve assessment of neurologic function and baseline vital signs. Decline of neurologic function after an acute ischemic stroke may indicate advancing neuronal injuries, thrombus propagation, early recurrent embolism,
or collateral vessel failure. Hemorrhagic transformation, hydrocephalus, intracranial edema, and herniation also can be responsible for decreasing neuronal function and in these instances, decompressive hemicraniectomy becomes an emergency. The anesthesiologist also should be concerned with common comorbid conditions, many of which are risk factors for the ischemic event. Current medications should be assessed with focus directed toward cardiovascular medications, anticoagulants, and antiplatelet medications. Evolving literature suggests a role for statin therapy in reducing postoperative morbidity and mortality. In the DECREASE III (Dutch Echocardiographic Cardiac Risk Evaluation Applying Stress Echocardiography) trial, patients started on fluvastatin at 80 mg demonstrated a 47% reduction in MI.16 The effect of modifications in head position on neurologic function has to be identified preoperatively as patients with vertebral artery disease are susceptible to angulation and compression of this artery with even minimal rotation, flexion, or extension of the head. Direct laryngoscopy for intubation predisposes the patient to unsafe head positions that can result in neurologic deficits. Carotid artery palpation should be avoided as this could induce fragmenting of the occlusion and embolism to the brain.
Intraoperative Monitoring Central nervous system monitoring devices include EEG, stump pressure measurement, transcranial Doppler, and cerebral oximetry. EEG remains a sensitive indicator of inadequate cerebral perfusion. Intraoperative neurologic complications have been shown to correlate well with EEG changes indicative of ischemia. Stump pressure measurement, which measures perfusion pressure, can be an important determinant of CBF. Although neither sensitive nor specific, it involves direct measurement of the retrograde internal carotid artery pressure following occlusion of the more proximal common and external carotid arteries. Only extreme values (<25 mm Hg) are useful indicators of the state of cerebral circulation. Transcranial Doppler has been used to measure blood flow velocity in the middle cerebral artery during CEA. Ischemia is severe if the mean velocity after clamping is 0 to 15% of preclamped value, mild if 16% to 40%, and absent if greater than 40%. Cerebral oximetry, or near-infrared spectroscopy, is a technique that relates neurologic outcome to cerebrovascular hemoglobin oxygen saturation. However, results suggest that there is no significant difference
CONTINUING MEDICAL EDUCATION
AUGUST 2012
between cerebrovascular hemoglobin oxygen saturation during preclamp or postclamp periods.17 In this regard, in vivo spectroscopy is used in many places as standard monitoring. Cerebral steal is defined as the decrease in blood flow to an ischemic area secondary to blood vessel dilation in non-ischemic areas. Given that the blood vessels in the ischemic areas have a fixed resistance, the reduction in pressure caused by vasodilation of adjacent vasculature diverts blood flow away from the ischemic area. However, vasoconstriction in non-ischemic areas of the brain may increase blood flow to the ischemic areas. This condition is known as either Robin Hood phenomenon or inverse steal. The clinical significance of both of these phenomena is not well understood.
Anesthetic Management The patient, the anesthesiologist, and the surgeon should agree as to whether regional or general anesthesia is preferred for the procedure. Surgeons vary in how they approach the procedure; therefore, the surgeon should be consulted prior to the surgery so that the anesthetic can be tailored to the surgeon and the patient. Finally, the anesthesiologist should proceed with the proposed anesthetic technique only if the anesthetic provider is comfortable with the technique and assesses that the technique is an acceptable one for the patient.18,19 General Anesthesia Currently, no anesthetic regimen has been proven to provide better cerebral perfusion and homeostasis, whether for carotid endarterectomy or stenting, although medications with rapid onset and short duration should be agents of first choice because they tend to decrease the postoperative influence on mental status and level of consciousness. Many anesthesiologists prefer general to regional anesthesia because not only are they more comfortable with this technique, but there also are some advantages associated with general anesthesia. General anesthesia is preferred in patients with anatomy/pathology that may make surgical conditions difficult. General anesthesia decreases cerebral metabolic demand and hence oxygen consumption, which is particularly important in a procedure where there are periods of decreased cerebral perfusion even if a shunt is placed. Another advantage is the ability to increase cerebral perfusion and oxygenation through manipulation of BP along with the ability to control levels of oxygen and carbon dioxide. Many also argue that general anesthesia enhances the patientâ&#x20AC;&#x2122;s comfort during the procedure. General anesthesia has been reported to be associated with increased use of vasoactive medications postoperatively along with extended anesthesia recovery time and recovery room stay.20 Several theories have been proposed to explain the efficacy of barbiturates to prevent or treat cerebral ischemia, yet conclusive studies are lacking. Etomidate has been used in neurovascular procedures because of its short duration of action, cardiac stability, and metabolic properties, but there is evidence in animals that etomidate worsens ischemic injury and therefore is not recommended for use as a cerebral protectant. Each of the volatile anesthetic agents produces a decrease in the cerebral metabolic rate of oxygen consumption and an increase in CBF. Desflurane affords the quickest recovery profile, which may offer an advantage for neurocognitive
assessment postoperatively. When appropriate, esmolol, labetalol, hydralazine, phenylephrine, ephedrine, nitroglycerin, and in rare circumstances, sodium nitroprusside can be employed to modulate BP and heart rate. When choosing fluids, less is probably better, especially if the patient is awake and no urinary catheter is placed. Regional Anesthesia The most common form of regional anesthesia used for CEA is a combination of a superficial and deep cervical plexus block with blocking of nerves originating from C2 to C4. It was previously thought that regional anesthesia was associated with a decrease in deaths and/or stroke, MIs, local hemorrhage, and pulmonary complications.18 However, Lewis et al published the results of the GALA (General Anaesthesia versus Local Anaesthesia for carotid endarterectomy) trial in which 3,526 randomized patients underwent general or regional anesthesia for CEA and there were no observed differences in the incidence of stroke, MI, or death.18 Other reports suggest that a regional anesthetic technique is associated with more selective shunt usage and may produce better anesthetic outcomes because the physicians are able to monitor cognitive function in a conscious patient providing confirmation of adequate cerebral perfusion during arterial clamping.20 Relative contraindications to the use of regional anesthesia include patient refusal, clotting abnormalities, airway compromise, prolonged surgery, local infection where the block is to be performed, chronic coughing, and an anxious patient.
monitor were placed and a total of midazolam 3 mg and propofol 240 mg were administered throughout the case. Postoperatively, the patient was given a total of labetalol 15 mg for elevated BP. He was discharged from the hospital the next day.
Summary Acute ischemic stroke is a neurologic emergency where the risks and the mechanisms of complications are yet to be completely understood. Patients requiring CEA secondary to carotid plaques can be managed effectively by both regional and general anesthetic techniques. Due to the complexity of cerebrovascular disease, anesthesiologists must recognize the pathophysiology of acute ischemic stroke and the challenges in managing these types of patients. Effective perioperative management of these complex patients can minimize postoperative morbidity and mortality.
Acknowledgment The authors wish to acknowledge Clinton Steffey, MD, for his contributions in an earlier version of this manuscript.
References 1.
http://www.strokecenter.org/patients/stats.htm
2.
Furie KL, Kasner SE, Adams RJ, et al. Guidelines for the prevention of stroke in patients with stroke or transient ischemic attack. A guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2011;42(1):227-276.
3.
Bravata DM, Wells CK, Kernan WN, Concato J, Brass LM, Gulanski BI. Association between impaired insulin sensitivity and stroke. Neuroepidemiology. 2005;25(2):69-74.
4.
Matz K, Keresztes K, Tatschi C, et al. Disorders of glucose metabolism in acute stroke patients: an underrecognized problem. Diabetes Care. 2006;29(4):792-797.
5.
Rodriguez BL, Lau N, Burchfiel CM, et al. Glucose intolerance and 23-year risk of coronary heart disease and total mortality: the Honolulu Heart Program. Diabetes Care. 1999;22(8):1262-1265.
6.
Reynolds K, Lewis B, Nolen JD, Kinney GL, Sathya B, He J. Alcohol consumption and risk of stroke: a meta-analysis. JAMA. 2003;289(5):579-588.
7.
Gordon NF, Gulanick M, Costa F, et al. Physical activity and exercise recommendations for stroke survivors: an American Heart Association Scientific Statement from the Council on Clinical Cardiology, Subcommittee on Exercise, Cardiac Rehabilitation, and Prevention; the Council on Cardiovascular Nursing; the Council on Nutrition, Physical Activity, and Metabolism; and the Stroke Council. Circulation. 2004;109(16):2031-2041.
8.
http://www.medpagetoday.com/Cardiology/Strokes?25852
9.
Adams HP Jr, del Zoppo G, Alberts MJ, et al. Guidelines for the early management of adults with ischemic stroke: a guideline from the American Heart Association/American Stroke Association Stroke Council, Clinical Cardiology Council, Cardiovascular Radiology and Intervention Council, and the Atherosclerotic Peripheral Vascular Disease and Quality of Care Outcomes in Research Interdisciplinary Working Groups: the American Academy of Neurology affirms the value of this guideline as an educational tool for neurologists. Stroke. 2007;38(5):1655.
Postoperative Period Patients should be monitored for BP changes, as hypertension peaks in the first 2 to 3 hours up to 24 hours postoperatively especially in patients who have predisposed risk factors such as essential hypertension. Systemic BP should be maintained at preoperative baseline to prevent myocardial ischemia and cerebral edema. If BP is not controlled, the complications that may arise include excessive bleeding at the operative site, intracerebral hemorrhage, increased ICP, and also myocardial ischemia and MI. Potent agents such as nitroprusside may be needed to treat refractory elevated BP. In case of hypotension, prompt evaluation and treatment are required. The exact mechanism for hemodynamic changes remains unknown; it may involve dysrhythmias, dehydration, decreased circulation secondary to medications, or renewed blood flow to the carotid sinus stimulating afferent nerve activity following surgery. Hypotension often is treated by ensuring first that there is no ongoing bleeding, IV crystalloid solutions, vasopressors, and/or injection of local anesthetics to the areas surrounding the carotid sinus. Finally, following CEA, patients need close observation to monitor for any type of respiratory distress. Airway obstruction secondary to overdose of anesthetics, hematoma, obesity, or obstructive sleep apnea syndrome commonly produces respiratory distress.
Case Management After options were discussed, the patient was treated with a regional technique. A total of 18 mL of ropivacaine 0.5% was administered in divided doses for combined deep and superficial cervical plexus blocks. Standard ASA monitors along with a V5 lead and brain awareness
10. Furlan A, Higashida RT, Wechsler L, et al. Intra-arterial prourokinase for acute ischemic stroke. The PROACT II study: a randomized controlled trial. Prolyse in acute cerebral thromboembolism. JAMA. 1999;282(21):2003-2011.
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11. Inouye M, Kishi K, Ikeda Y, et al. Prediction of functional outcome after stroke rehabilitation. Am J Phys Med Rehabil. 2000;79(6):513-518.
15. Meloni BP, Zhu H, Knickey NW. Is magnesium neuroprotective following global and focal cerebral ischaemia? A review of published studies. Magnes Res. 2006;19(2):123-137.
12. Adams RE, Powers WJ. Management of hypertension in acute intracerebral hemorrhage. Crit Care Clin. 1997;13(1):131-161.
16. Kalarickal PL, Fox CJ, Tsai JY, Liu H, Kaye AD. Perioperative statin use: an update. Anesthesiology Clin. 2010;28(4):739-751.
13. Warburton E, Alawneh JA, Clatworthy PL, Morris RS. Stroke management. Clin Evid (Online). 2011; pii: 0201.
17. Samra SK, Dorje P, Zelenock GB, Stanley JC. Cerebral oximetry in patients undergoing carotid endarterectomy under regional anesthesia. Stroke. 1996;27(1);49-55.
14. Herroeder S, Schönherr ME, De Hert SG, Hollmann MW. Magnesium—essentials for anesthesiologists. Anesthesiology. 2011;114(4):971-993.
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a multicentre, randomized controlled trial. Lancet. 2008;372(9656):2123-2142. 19. Erickson KM, Cole DJ. Carotid artery disease: stenting vs endarterectomy. Br J Anaesth. 2010;105(suppl 1):i34-i49. 20. Takolander R, Bergqvist D, Hulthén UL, Johansson A, Katzman PL. Carotid artery surgery: local versus general anesthesia as related to sympathetic activity and cardiovascular effects. Eur J Vas Surg. 1990;4(3):265-270.
18. Lewis SC, Warlow CP, Bodenham AR, et al. General anaesthesia versus local anaesthesia for carotid surgery (GALA):
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 email to Customer.Support@ProCEO.com.
For inquiries about course content only, send an email to ram.roth@mssm.edu. Ram Roth, MD, is director of PreAnesthetic Assessment Online and assistant professor of anesthesiology at The Mount Sinai School of Medicine, New York, NY.
Questions 1.
Over the next few years the number of stroke victims is expected to_____. a. increase b. decrease c. stay the same d. increase slightly, then decrease
6.
Medications of first choice should have which of the following qualities? a. Rapid onset and short duration b. Rapid onset and long duration c. Late onset and short duration d. Late onset and long duration
2.
A primary risk factor for acute ischemic stroke is_____. a. alcohol abuse b. diabetes c. intermittent atrial fibrillation d. obesity
7.
The anesthetic of choice for the patient undergoing carotid endarterectomy is____. a. regional technique b. general anesthesia c. neither as local infiltration suffices d. neither has been proven superior
3.
The ischemic penumbra is defined as the _____. a. region receiving insufficient blood flow b. region receiving intermediate blood flow c. region receiving normal blood flow d. region receiving no blood flow
8.
What is hyperperfusion syndrome? a. A synonym for hemorrhagic stroke. b. Inability of the brain to autoregulate secondary to prolonged decreased cerebral blood flow. c. Increased blood flow to one region of the brain resulting in another region becoming ischemic. d. Increased blood flow to the extremities.
9.
In the acute ischemic stroke patient, the anesthesiologist must____. a. maintain cerebral perfusion pressure b. maintain systemic hemodynamic stability c. understand the pathophysiology of acute ischemic stroke d. All of the above
4.
5.
Within what time period can recombinant tissue plasminogen activator be used in patients from the onset of symptoms? a. 20 minutes b. 1 hour c. 4-5 hours d. Should not be used Vasoconstriction in non-ischemic areas of the brain that may increase blood flow to the ischemic area is known as____. a. cerebral steal b. Robin Hood phenomenon c. hemorrhagic transformation d. deep vein thrombosis
Note: Lesson 297 Part 2 of the PreAnesthetic Assessment should have been listed as Lesson 298.
10. Preferred cerebral monitoring during carotid endarterectomy includes____. a. cerebral oximetry b. arterial pressure c. temperature d. All of the above
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Admir Hadzic December 7, 2011 The second edition places an emphasis on clarity, standardization and safety of peripheral nerve block techniques. Featuring sections that progress from the foundations of regional anesthesia to the clinical applications of nerve blocks, this book includes tips and a unique atlas of ultrasound anatomy for regional anesthesia and pain medicine.
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Robert L. Lennon, Terese T. Horlocker June 1, 2006 This DVD is a visual tutorial on approaches to perioperative regional anesthesia and analgesia, offering structured video primers and vivid presentations of regional techniques to guide users through the selection of equipment, strategies in pain management and the management of inpatient and ambulatory peripheral nerve catheters.
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Jeffrey Kirsch July 12, 2012 This issue of Anesthesiology Clinics s provides essential updates in neurosurgical anesthesia. Topics include anesthesia for endovascular neurosurgery, interventional neuroradiology, neuroimaging, anesthetic management of patients with acute stroke, perioperative management of pediatric patients and airway management in neuroanesthesiology.
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56 I AnesthesiologyNews.com
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C OMM E NT A R Y
Inspector General Weighs In on Fee Sharing
I
n a much-awaited pronouncement, the U.S. Department of Health and Human Services’ Office of Inspector General (OIG) in June issued Advisory Opinion 12-06 addressing the propriety of two popular schemes to extract money from anesthesiologists, the so-called “company model” and the “management fee.” The advisory opinion could not be more welcome, as in the approximately 1.5 years since my article, “The Company Model: Is Taking Less Money To Work at a Surgicenter Worth Jail Time?” ((Anesthesiology News, January 2011), was published, the pace at which surgeons and ambulatory surgery centers (ASCs) are exploiting the company model appears to be accelerating. To draw once again on the analogy used in that earlier article, just as Willie Sutton, the bank robber, targeted banks “because that’s where the money is,” owners of ASCs continue to seek a share of anesthesia fees.
The Company Model Business Model In its most direct form, the company model involves the formation, by the surgeon-owners of an ASC, of an anesthesia services company to provide all of the anesthesia services for the center. Before the formation of the company, all anesthesia services were provided by anesthesiologists either for their separate accounts or for the account of their anesthesia group. After the formation of the company, anesthesiologists are employed or subcontracted, with a significant share of the anesthesia fee being redirected to the company model’s owners, the surgeons. Management Fee Model In the management fee model, the ASC charges the anesthesiologists a fee for use of portions of its facility, or for services and other overhead required in the context of serving the facility’s patients.
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Key Compliance Issues The federal anti-kickback statute (AKS) prohibits the transfer of anything of value for referrals. State laws differ, but generally contain similar provisions barring remuneration for referrals. This article focuses on the federal concepts applicable to patients covered under Medicare and Medicaid. Courts have interpreted the AKS to apply even when an arrangement may have many legitimate purposes; the fact that one of the purposes is to obtain money for the referral of services or to induce further referrals is sufficient to trigger a violation of the law. Certain exceptions, known as “safe harbors,” define permissible practices not subject to the AKS because regulators believe they are unlikely to result in fraud or abuse. The failure to fit within a safe harbor does not mean that an arrangement violates the law; there’s just no free pass. The question for the company model or for management fee deals, then, is whether the arrangement runs afoul of federal anti-kickbackk law. Each deal must be analyzed carefully. Prior OIG Guidance The OIG previously issued two fraud alerts applicable to the analysis of company model deals: its 1989 Special Fraud Alert on Joint Venture Arrangements, which was republished in 1994, and a 2003 Special Advisory Bulletin on Contractual Joint Ventures. The OIG considers a “joint venture” to mean any arrangement, whether contractual or involving a new legal entity, between parties in a position to refer business and those providing items or services for which Medicare or Medicaid pays. The OIG has made clear that compliance with both the form and the substance of a safe harbor is required in order for it to provide protection. The OIG demands that if one underlying intent is to obtain a benefit for the referral of patients, the safe harbor would be unavailable and the AKS would be violated.
service to the owner’s existing patient population. Note that the term “existing provider” is not limited to situations in which anesthesiologists have an existing relationship with the ASC at the time the company model joint venture is formed. The bulletin lists some of the common elements of these problematic structures: • The owner expands into a related line of business that is dependent on direct or indirect referrals from, or on other business generated by, the owner’s existing business. • The owner does not operate the new business—the manager/supplier does—and does not commit substantial funds or human resources to it. • Absent participation in the joint venture, the manager/supplier would be a competitor in the new line of business, providing services, billing and collecting in its own name. • The owner and the manager/supplier share in the economic benefit of the owner’s new business. • The aggregate payments to the owner vary based on the owner’s referrals to the new business. Those elements hint at a company model structure in which an ASC, or some or all of its surgeon-owners, forms an anesthesia company for the purpose of providing anesthesia services to itself. Little capital is required. The anesthesiologists, not the owners, provide the services. But for their engagement by the company, they would be providing anesthesia services for their own account. The owners of the company capture a share of the anesthesia revenue. And importantly, the more cases the ASC or its surgeons refer to the company, the more money those owners make. The 2003 bulletin states that despite attempting to fit the contracts creating these joint venture relationships into safe harbors, such protection might not be available, as they would protect only the payments from the owner to the manager/supplier for services rendered. They would not shield the “payment” from the manager/supplier back to the owner in the form of its agreement to provide services to the joint venture for less than the available reimbursement—that is, the “discount” given within the joint venture.
2003 Special Advisory Bulletin The 2003 Special Advisory Bulletin sheds light on company model structures. It focuses on arrangements in which a health care provider in an initial line of business, the “owner,” expands into a related business by contracting with an existing provider 2012 Advisory Opinion 12-06 of the item or service, the “manager/ The OIG’s June 1, 2012, Advisory supplier,” to provide the new item or Opinion 12-06 was that agency’s first
AnesthesiologyNews.com I 57
AUGUST 2012
COMME N TA R Y pronouncement directly on the propriety of the company model. And importantly, that opinion also addresses the management fee arrangement. In Advisory Opinion 12-06, the requestor, an anesthesia group, set out two alternative proposed scenarios in regard to its relationship with a group of ASCs owned by surgeons. Alternative A—The Management Fee The anesthesia group would continue to serve as the ASCs’ exclusive anesthesia provider and bill and collect for its own account. However, it would pay the ASCs for “management services,” including preoperative nursing assessments, space for all the group’s physicians’ material and their personal effects, and for assistance with transferring billing documentation to the group’s billing office. Although both Medicare and private payers set their reimbursement to ASCs taking into account the expenses of the type included within the management fee, the ASCs would continue to bill Medicare and private payers in the same amount as currently billed. The management fee would be at fair market value and determined on a per-patient basis. No management fee would be charged in connection with federal health care program patients. Consistent with its longstanding viewpoint, the OIG found that carving out federally funded patients was ineffective to remove the proposed arrangement from within the purview of the AKS, because the payment of the fee in connection with private payers would influence the decision to refer all cases, thereby not reducing the risk that their payment is made to induce the referral of the federally funded ones. The OIG stated that the AKS seeks to ensure that referrals will be based on sound medical judgment, and competition for business based on quality and convenience, instead of paying for referrals. But under the management fee proposal, the ASCs would be paid twice for the same services, by Medicare or by the private payer via the facility fee, and then also by the anesthesiologists via the management fee. That double payment could unduly influence the ASCs to select the requestor as the ASCs’ exclusive provider of anesthesia services. Alternative B—The Company Model The surgeon-owners of the ASCs would set up a series of entities to provide anesthesia services, on an exclusive
basis, at each of the ASCs. Those entities would be wholly owned either directly by the surgeon’s entities or by the ASCs. Those anesthesia companies, in turn, would engage the requestor anesthesia group on an exclusive basis as an independent contractor to provide the actual anesthesia care and certain related services, described in the Opinion as including: • recruiting, credentialing and scheduling anesthesia personnel; • ordering and maintaining supplies and equipment; • assisting the anesthesia companies in selecting and working with a reputable anesthesia billing company; • monitoring and overseeing regulatory compliance; • providing financial reports; • implementing quality assurance programs; and • providing logistics (including, if necessary, assisting the anesthesia companies in structuring independent contractor or employment relationships with anesthesia personnel and assisting in establishing a separate anesthesia corporation). In turn, the anesthesia companies would pay the requestor a negotiated rate for the services. The fees for the services would be paid out of the anesthesia-related collections, with the anesthesia companies retaining any profits. In analyzing the company model alternative, the OIG stated that even if one assumed that the surgeoninvestors qualified for the ASC safe harbor in respect of their investment in the surgery center, there was no safe harbor available in respect of the distributions that they would receive from their anesthesia company. The ASC safe harbor protects returns on investments only in circumstances where the investment entity itself is a Medicarecertified ASC, which is an entity that operates exclusively for the purpose of providing surgical service, and anesthesia services are not surgical services. Even if the safe harbor for payment to employees applied or if the safe harbor for personal services contracts applied, and therefore the payments to the anesthesiologists were protected by a safe harbor (note that this means that the payments were at fair market value, which is what many experts think is the magic bullet in terms of all compliance—it is not), neither of those safe harbors would apply to the company model profits that would be distributed to the ASCs’ physician-owners, and such remuneration would be prohibited
under the AKS if one purpose of the remuneration is to generate or reward referrals for anesthesia services. After stating that the failure to qualify for a safe harbor does not automatically render an arrangement a violation of the AKS, the OIG then turned to an analysis pursuant to the 2003 Special Advisory Bulletin (discussed above) and found that the physician-owners of the proposed company model entity would be in almost the exact same position as the suspect joint venture described in the Bulletin: that is, in a position to receive indirectly what they cannot legally receive directly—a share of the anesthesiologists’ fees in return for referrals. Therefore, the OIG stated that the proposed company model venture would pose more than a minimal risk for fraud and abuse. In sum, the OIG concluded that either of the proposed arrangements, the management fee arrangement or the company model arrangement, could potentially generate prohibited remuneration under the AKS, and the OIG potentially could impose administrative sanctions on the requestor.
The Bottom Line The bottom line is that both company model ventures and management fee arrangements are fraught with kickback danger for all parties involved. Note that there is no requirement that there be a third entity, the so-called anesthesia company, involved for the analysis applied by the OIG to apply: Similar arrangements directly between an ASC and anesthesiologists trigger the same concerns. Each situation must be analyzed carefully, because there is a high chance of an AKS violation leading to criminal fines, civil penalties, exclusion as a provider and even imprisonment. —Mark F. Weiss, JD Mark F. Weiss, JD, is an attorney who specializes in the business and legal issues affecting physicians and physician groups on a national basis. He holds an appointment as clinical assistant professor of anesthesiology at USC Keck School of Medicine and practices with Advisory Law Group, a firm with offices in Los Angeles and Santa Barbara, California, representing clients across the country. He can be reached by email at markweiss@advisorylawgroup.com.
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‘A Few Sweet Kisses’: A History of Self-Experimentation In Anesthesia (Part 2)
T
he introduction of curare into clinical pracf tice in 1942 prompted some fascinating selfexperiments. In January of that year, two Montreal physicians, Harold R. Griffith and Enid Johnson, used curare along with artificial respiration in a surgical patient and found much less anesthetic gas was needed. Griffith had previously selff experimented with cyclopropane, but is not known to have done so with curare. A physician in London and one in Salt Lake City would independently use themselves in curare experiments. Frederick Prescott, a doctor and a doctorate in chemistry, was clinical research director at Burroughs Wellcome where a pure form of d-tubocurarine known as Tubarine had been successfully tested in animals in 1944. Prescott felt that other drugs given to patients might interfere with a study of Tubarine in humans and also was reluctant to ask fellow researchers or students to be guinea pigs. Prescott had already used himself in a study to determine the effect of a morphine-methamphetamine combination on blood pressure, so he volunteered. The experiment was conducted in an operating room in London’s Westminster Hospital and a respected anesthesiologist, Geoffrey Organe, administered the Tubarine. Over the next several weeks, Prescott submitted to administrations of everincreasingg levels of the drug so that dosing concentrations could be determined. A hand-compressed air bag attached to his mouth th bby a ttube b
provided artificial respiration. Although Prescott survived these experiments, he remembered a vivid sense of suffocation in interviews many years later. At about the same time, Scott M. Smith and other anesthesiologists at the University of Utah School of Medicine had begun using Secostrin, the commercial version of curare in North America, in some patients. Curare’s effects on the brain were unknown and much debated in the medical literature. There also were questions about curare’s ability alone to block pain. Smith developed a protocol with himself as the study subject for administration of a large dose of curare during which he would be able to communicate as long as possible—something Prescott and the others had not considered. He secured the assistance of a fellow faculty member, pharmacologist Louis S. Goodman (of “Goodman & Gilman” fame). The Utah researchers were unaware of what Prescott had done in London, since that work would not be published for several more months. The experiment took place on the afternoon of Jan. 10, 1946. The results were published in the January 1947 issue of Anesthesiology as “The lack of cerebral effects of d-tubocurarine.” Smith was the first of four authors. The “Experimental Procedure” section began with a rather bland description: “The subject was a healthy male adult, 34 years of age, weighing 80 Kg.” The “Results” section contained a detailed timeline between 2 and 6 p.m. The “Subject Report” noted “The subject remained acutely conscious i throughout th h t th the experiment i t andd memory was
unimpaired” and continued with a detailed report by Smith of his experience. Through procedures conducted on him during those hours, Smith learned that curare did not deaden pain and did not change consciousness. That night he told his wife for the f experiment; she indicated he first time about his selfhad better not attempt something that crazy again. f experiments with curarizing agents The selfdid not end with the work of Prescott and Smith. Between 1949 and 1952, various others used their own bodies to study the drugs: Max Sadove and others at the University of Illinois College of Medicine in Chicago, as well as Otto Mayrhofer in Austria and Richard Bodman at the University of Bristol in England. Such selff experiments with muscle relaxants are known to have taken place as recently as 1988. Today’s research oversight atmosphere may prevent selff experimentation, but the history of the specialty is filled with examples. William Halsted and Richard Hall of New York City became addicted to cocaine f experiments in the as a result of their extensive selfearly days of that drug’s use as a local anesthetic in 1884 and 1885. In those same years, physicians in New York, Massachusetts, New Jersey, Pennsylvania and Ireland are known to have selff experimented with cocaine. Many others who did not record their experiences in the medical literature probably did so as well. The great German surgeon Heinrich Braun, who in 1905 introduced procaine into clinical practice, and an assis assistant injected themselves with encain, aneson, stovain ne, alypin and adrenaline in their search for local aanesthesia substitutes for cocaine. From the 1930s into i the 1950s, researchers Thomas Lewis, James D. H Hardy, Harold G. Wolff, Helen Goodell and otherrs subjected themselves to needle scratches, hammeer blows, freezing, molten wax and ultraviolet ligght in their studies of pain sensation. In March 1923, two researchers in Chicago, Arno B. Luckhardt and J.B. Carter, anesthetized each other with ethylene. Days later, theyy introduced the gas into clinical practice at P Presbyterian Hospital. An even faster track from m research to operating room also took placee in Chicago in April 1952. Max Sadove becaame the first human to receive a fluroxene an nesthetic; within an hour after he revived hee was administering it to a middle-aged woman for a rectal operation. w Many individuals have used a mix of bbravery and recklessness to produce many advances in medicine, and anesthesiology has certainly had its share. We may not see their kind again. —A.J. Wright, MLS Mr. Wrigght is an historian in the anesthesiology department at the University of Alabama School of Medicine, at Birminghham. The first installment of this series appeared in the July 2012 issue (page 38).
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REPORT Reducing the Risk for Microaspiration and Postintubation Pulmonary Complications In the Surgical and Critical Care Settings: Innovations in Endotracheal Tube Cuff Design stay (LOS) by 89%.5 It accounts for $8.98 billion in hosespite significant advances in endotracheal tube (ETT) design and management of intubated pital costs,6 $3.42 billion of which is incremental resource patients, infectious and noninuse added by PPCs to elective fectious postintubation pulmosurgery costs.7 nary complications—ranging Among the most comFaculty from bronchospasm to respiramon PPCs, ventilator-associattory failure—remain costly and ed pneumonia (VAP) —defined Sabrina Bent, MD, MS significant causes of morbidity as pneumonia occurring in a Clinical Associate Professor of and mortality.1,2 In the surgical mechanically ventilated patient Anesthesiology and Pediatrics after 48 hours of endotracheal setting, postoperative pulmoDirector of Research intubation—affects up to 40% of nary complications (PPCs) affect Department of Anesthesiology patients in surgical intensive care 1 in 8 patients,3 are a leadTulane University School of Medicine units (ICUs), which have high ing cause of hospital readmisNew Orleans, Louisiana rates of mechanical ventilation, sions,4 and are associated with and accounts for 25% of infec70% of all postoperative hospiEric Toschlog, MD tions in medical ICUs.8 Aspiratal deaths among patients withAssociate Professor of Surgery out known respiratory problems tion is a leading cause of VAP, Director of Surgical Critical Care before surgery.3 Among nonand both are targets for clinical The Brody School of Medicine at intervention.9-11 cardiac surgery patients, postEast Carolina University operative pneumonia has been Artificial airway use is assoGreenville, North Carolina shown to increase hospital costs ciated with 80% of cases of by 55% and hospital length of hospital-acquired pneumonia,
D
Supported by
REPORT
Figure 1. TaperGuard cuff. Image used by permission from Nellcor Puritan Bennett, LLC, Boulder, Colorado, doing business as Covidien.
which is concentrated in the first few days of intubation.12 ETTs—which are indicated and widely used for airway management in surgical and critical care settings—are first-line defenses in limiting or preventing postintubation complications. With evidence implicating microaspiration (ie, “silent” aspiration) of contaminated endotracheal secretions and gastric contents passing the cuff of the airway device (eg, ETT) as a contributor to incidence and severity of VAP, 2,12-16 clinicians should consider reducing pathogenic factors (eg, colonization, biofilm formation) and limiting aspiration as favorable approaches for minimizing risk for PPCs.13,17 Improved cuff-sealing properties that reduce the rate of secretion leakage, coupled with deployment of technology that removes secretions above the cuff, may aid clinicians in reducing downstream pulmonary complications. Recent advances in ETT material and cuff designs, including a tapered polyvinylchloride (PVC) cuff (TaperGuard™, Covidien) have allowed for evaluation in bench studies and clinical settings to further address the challenges associated with microaspiration and improve clinical outcomes (Figure 1). With ETTs available in different materials and shapes, as well as innovations including an independent dorsal suction lumen that permits continuous aspiration of subglottic secretions, clinicians are in a position to reduce microaspiration and improve patient outcomes.
The Role of Microaspiration In Pulmonary Infection The pathogenesis of pulmonary infection is multifactorial and requires several key processes. Microaspiration of fluids from the subglottic space and bacterial colonization of the lower respiratory tract can lead to pulmonary infection including VAP.11,18 Colonization of the lower respiratory tract is associated with ventilator-associated tracheobronchitis—an intermediate condition in the continuum between colonization and pneumonia.19
2
Certain characteristics of intubation favor aspiration of bacteria from the oropharynx into the lower respiratory tract 20 ; thus, the ETT may function as a direct portal for the organisms entering the lungs.19,21,22 The tube breaches anatomic barriers formed by the glottis and larynx,12,19 thus impeding normal mechanical host defenses. Impairment of the cough reflex during intubation further impedes natural reflexes that normally would prevent aspiration. An ETT forms a favorable surface for biofilm formation and acts as a reservoir for infective microorganisms, which subsequently may be dislodged into the lung by ventilator gas flow. 2,15,16 Infection results from the microbial invasion into the normally sterile lower respiratory tract and lungs, overwhelming host defenses and increasing the risk for infection.15,16,21 Dual mechanical and pathogenic factors contribute to risks for microaspiration, which is a formidable but modifiable complication (Table 1).15 The earliest ETT cuffs required high pressures (>60 cm/H2O) to achieve a seal and were associated with frequent tracheal injury23; high-volume, low-pressure (HVLP) cuffs introduced in the 1970s have demonstrated inadequate sealing.21,24,25 The diameter of the inflated conventional cuff is up to twice as large as the diameter of the trachea9,23,24; thus, even with properly sized tubes and appropriate inflation, leakage occurs down a gravitational gradient, often as a result of folding in the cuff wall.23-26 Differential sealing properties can have clinical consequences. A prospective study found gastric pathogens— evidence of microaspiration—in the sputum found in the lungs of 28% of postoperative patients; this group had a 40% incidence for pneumonia compared with 12% in patients without microaspiration.27 An earlier bench study confirmed evidence of frequent microaspiration with conventional low-pressure cuffs: Nearly 80% of tubes leaked all 20 mL of fluid placed above the cuff.28
Diagnosis of Microaspiration Despite its prevalence in critical care and surgical settings, microaspiration remains challenging to diagnose. Few available markers—including methylene blue—can provide accurate quantitative diagnosis in intubated patients.15 Methylene blue is reliable but relatively complex to use in the clinical setting because it requires fiber-optic bronchoscopy for detecting its presence under the tracheal cuff.15 Limitations also are apparent with other available aspiration markers. Among these are nonabsorbable radioisotopes (eg, technetium 99m sulfur colloid)—the use of which is restricted to nuclear medicine departments—and pepsin, which occurs naturally in gastric contents but not in tracheal secretions; its use diagnostically can be problematic because it may be degraded in the alkaline environment of the lung.15
Strategies for Preventing Postintubation Complications Various strategies may aid clinicians in reducing or preventing postintubation complications in surgical and critical care settings. These include reducing patient time on mechanical ventilation, limiting bacterial colonization, and reducing microaspiration.15,29
REPORT Specific measures are known to reduce VAP incidence in critical care settings and include elevating the head of the bed, prophylaxis of stress gastritis, and limiting sedation.30-32
Reducing Microaspiration Cuff pressure is highly variable over time. A prospective observational cohort study of patients in the ICU intubated with high-volume, low-pressure cuffs found that only 18% of patients spent 100% of recorded time with normal cuff pressure (ie, 20-30 cm H2O), and cuff underinflation was a risk factor for microaspiration and VAP.33 Pneumonia prevention and management guidelines issued jointly by the American Thoracic Society/Infectious Diseases Society of America (ATS/IDSA) recommend maintaining a cuff pressure greater than 20 cm H2O16 for the prevention of VAP, and the Society for Healthcare Epidemiology of America 34 (SHEA) recommends maintaining a cuff pressure of at least 20 cm H2O.35-37 Although evidence to support semi-recumbent positioning for the prevention of microaspiration is incomplete, a role for it has been established.29,38 Semi-recumbent positioning is recommended in a number of practice guidelines, including those issued jointly by the ATS/IDSA and a guideline issued by SHEA.29,35
as a marker for gastric-content aspiration in critically ill tubefed patients, 88.9% had evidence of at least 1 aspiration event; high sedation, aspiration, and use of paralytic agents were significant independent risk factors for pneumonia.46 Paired sedation-and-weaning protocols can result in shorter duration of ventilation and reductions in hospital and ICU LOS.34
Considerations in Selecting an ETT The contribution of the ETT cuff to microaspiration and pulmonary complications is substantial. Two main functions of ETT cuffs are to produce a protective, airtight seal between the tube and the tracheal mucosa to facilitate positive pressure ventilation and to protect the lower airway.45 However, decades of clinical experience with conventional cuffs (cylindrical shape; HVLP; <30 cm H 2O) have confirmed that pooling and leaking across the cuff leads to aspirationâ&#x20AC;&#x201D;the main route of bacteria to invade the lower airways. 21,22,25 This is confirmed by the finding that persistent cuff underinflation (<20 cm H 2O) is independently associated with pneumonia. 33 Also, the presence of pepsin in tracheal aspirates is an independent predictor of pneumonia in intubated patients.46 Recently introduced cuff designs were developed to alleviate problems with conventional HVLP ETTs and to provide
Limiting Bacterial Colonization Evidence suggests that subglottic secretion drainage can reduce the risk for early- and late-onset VAP.11,35,39,40 In a randomized prospective study, continuous aspiration of subglottic secretions (CASS) in ventilated patients after major heart surgery significantly reduced antibiotic use in the whole cohort, as well as VAP incidence in high-risk patients (ie, those who required mechanical ventilation for >48 hours) compared with intermittent aspiration.11 Recently, a study that assessed intermittent aspiration with routine care in patients requiring mechanical ventilation for at least 48 hours found significantly lower incidence of early- and late-onset VAP compared with the control group.40 A recent meta-analysis confirmed a highly significant reduction in VAP of approximately 50% in mechanically ventilated patients who, at the time of original intubation, received an ETT with subglottic secretion drainage capability.41 Continuous suctioning has been found to be cost-effective compared with intermittent ventilation, despite challenging scenarios of VAP incidence and associated costs42; costs attributed to a single VAP episode range from $5,365 to $57,000.43,44 Varying levels of evidence also support general VAP prophylactic measures (eg, infection control, oral decontamination, stress ulcer prophylaxis, and avoidance of gastric distension).31,35,45
Reducing Time on Mechanical Ventilation Mechanical ventilation is accompanied almost universally by administration of large doses of sedatives. However, this combination is associated with significant morbidity.32 Duration of mechanical ventilation can be associated with adverse patient outcomes, and evidence supports reducing duration of mechanical ventilation in intensive care populations.29 In a prospective study that used pepsin-positive tracheal secretions
Table 1. Risk Factors for Microaspiration in Intubated Critically Ill Patients Tracheal tube Longitudinal folds in HVLP tracheal cuff Underinflation of tracheal cuff
Mechanical ventilation Zero PEEP Low peak inspiratory pressure Tracheal suctioning
Nasogastric tube and enteral nutrition Gastric distension Gastroesophageal reflux
Patient-related factor Pressure above cuff Tracheal diameter Viscosity of secretions above the cuff Supine position Sedation HVLP, high-volume, low-pressure; PEEP, positive end expiratory pressure Adapted from reference 15.
3
REPORT
Table 2. Comparison of Different Cuff Materials in Reducing Fluid Leakage Endotracheal Tube
Material
Shape
Diameter, cm
Length, cm
Double-layer prototype
Guayule latex
Cylindrical
3.6
3.4
Hi-Lo (Covidien)
PVC
Cylindrical
3.6
3.4
Hi-Contour (Covidien)
PVC
Cylindrical
3.2
3.2
Microcuff (Kimberly-Clark)
PU
Cylindrical
4.7
2.3
Ivory (Smiths Medical)
PVC
Cylindrical
3.3
3
SealGuard (Covidien)
PU
Tapered
4.7
1.6-2.4
TaperGuard (Covidien)
PVC
Tapered
3.8
1.4-2.5
PVC, polyvinylchloride; PU, polyurethane Based on reference 9.
improved sealing properties across a range of tracheal diameters. Available cuff materials include PVC, polyurethane (PU), and guayule latex, whereas the cuff shapes may be cylindrical or tapered. PU-cuffed tubes are characterized by a thinner wall (7 vs the more typical 50 microns) that creates a stronger seal at safe cuff-inflation pressures.47,48 Cuff material and positive pressure have been shown to be major determinants in reducing leakage past the cuff.9 Certain tapered cuff designs ensure a “sealing zone” that aligns the outer cuff diameter with the internal tracheal diameter15; a smaller force transmitted to the trachea may reduce the risk for tracheal injury. Both PVC- and PU-tapered shape tubes have demonstrated, in bench and clinical studies, high sealing properties that aid in preventing fluid leakage.9,47 The influence of cuff shape on fluid leakage is particularly evident among PVC cuffs.9 Both the TaperGuard ETT and the TaperGuard™ Evac tube—which has an independent suction lumen with a dorsal opening above the cuff—have been shown to reduce microaspiration by an average of 90% compared with the Hi-Lo (Covidien) cylindrical cuff.49
Cuff Sealing and Microaspiration: Recent Evidence Sealing properties of 6 HVLP cuffs made of different materials and shapes were evaluated in a well-designed 24-hour bench study by Zanella et al.9 At incremental
4
positive end-expiratory pressure (PEEP) levels, water leakage (10 cm) was compared across a double-layer guayule latex cuff prototype, 3 cylindrical PVC cuffs (Hi-Lo, Hi-Contour; Ivory, Smiths Medical), a tapered PVC cuff (TaperGuard), and 2 PU cuffs: one tapered (SealGuard™, Covidien) and one cylindrical (Microcuff, Kimberly-Clark) (Table 2).9 The guayule cuff prevented leakage at all PEEP levels. Both shapes of PU cuffs showed limited leakage (2.1±1.8 cm H2O) only for PEEP 0.9 Reduced leakage was observed with the PVC cuffs at increasing PEEP levels (8.4±1.5, 7.8±2.2, 2.2±1.0, and 0 cm H2O at 0, 5, 10, and 15 cm H2O, respectively).9 Among all the PVC cuffs, the tapered shape ensured higher sealing properties—which is consistent with previously published findings. 25 Zanella et al demonstrated that both the PU and PVC cuffs required incremental levels of PEEP to prevent fluid leakage.9 The finding of PEEP as a protective factor is important because PEEP loss occurs frequently in clinical practice. Another recent randomized study evaluated tracheal cuff leakage in morbidly obese gastric bypass patients (N=63), a population at high risk for microaspiration.50 Preliminary findings showed that the TaperGuard ETT provided 100% protection against microaspiration detected by bronchoscopy, compared with a microaspiration rate of 41% (13 of 32) among patients intubated with a cylindrical PVC tube (Hi-Lo) (Figure 2).50 The relationship between VAP and microaspiration from inadequately sealing cuffs is a topic of clinical and scientific
interest. A retrospective analysis of intubated patients following the introduction of ETTs with PU cuffs showed a significant reduction in VAP to 2.8 per 1,000 ventilator-days, compared with no less than 5.3 with the use of conventional ETTs.51 Under specific clinical circumstances (ie, patients expected to receive mechanical ventilation for >3 days), the TaperGuard Evac tube has been associated with significantly lower clinically diagnosed VAP incidence rates.49 VAP incidence can remain high even with adherence to prevention protocols including oral care and patient positioning, and switching from a cylindrical to a tapered cuff may be a reasonable approach to mitigating this risk. In preliminary data reported in 2011, reduction in days to successful extubation and VAP rate was achieved after conversion from the Hi-Lo cylindrical tube to an ETT with a tapered cuff and subglottic secretion suction (SealGuard Evac). 52 Although there is insufficient evidence to support the selection of one ETT over another on the basis of VAP prevention, adequate sealing is a key element in reducing downstream complications. Modifications in design and material of ETTs represent an important advance in VAP prevention.9,15
Conclusion Unexpected intraoperative complications (eg, bleeding, hypotension, or long duration of surgery or mechanical ventilation) can increase the risk for VAP. Thus, determining effective interventions (eg, initial selection of an ETT in the operating room) that may reduce microaspiration risks and subsequent VAP require clinical judgment. Institutional costâ&#x20AC;&#x201C;benefit analysis may be prudent for understanding incremental costs of preventive measures compared with costs of managing PPCs. Although the clinical importance of ETT selection may not be fully appreciated, initial placement of the most appropriate tube may have clinical consequences both intra- and postoperatively, in the ICU; failure to do so may represent a lost opportunity for prevention.
Patients Protected from Microaspiration, %
REPORT
100
75
50
25
0
TaperGuard
Hi-Lo
Figure 2. A comparison of patients being intubated with TaperGuard or Hi-Lo cuffed endotracheal tubes to assess aspiration. Based on reference 50.
Case Study 1 A 67-year-old man undergoing an open right hemicolectomy. Sabrina Bent, MD
T
he patient had been diagnosed with adenocarcinoma of the right colon by colonoscopy 2 weeks earlier. The patient had a significant smoking history (ie, 1 pack/day for 33 years), obstructive sleep apnea, hypertension, type 2 diabetes mellitus, and gastroesophageal reflux disease. Four years earlier, he had undergone an open radical prostatectomy, and an open cholecystectomy 27 years earlier. A history of pneumonia was reported following his prostatectomy, which resulted in a readmission to the hospital less than 1 week after being discharged. His chest x-ray showed no acute disease, but was noted to have mild hyperinflation. His labs, including
complete blood count and complete metabolic panel, were within normal limits with the exception of the glucose level, which was 206 mg/dL. The anesthetic management consisted only of general anesthesia with ETT placement without regional anesthesia due to patient refusal of all neuraxial anesthetics. The patient was intubated with the TaperGuard Evac ETT to allow subglottic suctioning of his secretions during the operation and to decrease his risk for VAP if postoperative ventilation was necessary. A nasogastric (NG) tube was placed for gastric decompression during surgery and for the postoperative period.
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REPORT Intraoperatively, the NG tube was placed on full suction to empty the stomach upon insertion, but was left open to gravity for the remainder of the surgical procedure. Approximately 100 mL of clear, yellow gastric secretions were initially aspirated from the NG tube. The suction port of the TaperGuard Evac ETT was set to low intermittent suction at 150 mm Hg. The suction regulator had a preset cycle of intermittent suctioning for 15 seconds followed by an 8-second pause. The operation lasted approximately 5 hours. During this time, approximately 18 mL of viscous straw-colored fluid was suctioned from the subglottic opening of the ETT. A portion of the secretions was sterilely collected in a Lukens trap for culture. The surgery was uneventful and the patient was extubated at the end of the procedure. He was subsequently taken to the postanesthesia care unit on 10 L per minute of oxygen via nonrebreather face mask. He was weaned to 2 L per minute of nasal
cannula oxygen prior to transport to the telemetry floor of the hospital for continuous pulse oximetry monitoring. The patient was placed on a hydromorphone patient-controlled analgesia pump for postoperative pain management. The oxygen was discontinued on postoperative day (POD) 2. The cultures from the subglottic secretions collected intraoperatively grew Escherichia coli (respiratory pathogen), Streptococcus pneumonia (respiratory pathogen), and Stomatococcus mucilaginosus. The remainder of the postoperative course was unremarkable and the patient was discharged home on POD 6. He was seen by his internist more than 4 weeks postoperatively and had no symptoms or signs of pneumonia. His pulmonary status was unchanged compared with his preoperative baseline. The patient was very pleased with his outcome and lack of postoperative pulmonary complications.
Note: The case study presented is a composite and not intended to identify a specific patient.
Case Study 2 A 24-year-old man undergoing emergency splenectomy following a motorcycle accident. Eric Toschlog, MD
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he patient had been involved in a motorcycle accident and was taken to the trauma resuscitation area. He was observed to be apneic and unresponsive in the field, and was intubated by the aeromedical crew. His intubation was challenging in the austere environment of the crash scene, and he was noted to aspirate. On arrival to the resuscitation bay, his airway was intact; he had bilateral decreased breath sounds and faint femoral pulses. He had bilateral chest wall subcutaneous emphysema and paradoxical chest wall movement from a clinical left flail chest. Bilateral chest tubes were placed urgently with release of pleural air and hemothorax. His hemodynamics improved sufficiently for him to be taken to get a computed tomographic scan. His injury constellation included subarachnoid and intraparenchymal shear hemorrhages; an unstable cervical spine fracture; numerous bilateral rib fractures, including a left hemopneumothorax; and a splenic laceration with contrast extravasation suggestive of active arterial hemorrhage. He became hypotensive during imaging, and was taken urgently to the operating room for splenectomy. After a rapid splenectomy and large-volume blood product resuscitation, he stabilized. At this time, the anesthesiologist performed a video laryngoscopy to assess the safety of an ETT change. This decision was based on the knowledge that the patient would likely undergo a prolonged ICU stay with high risk for acute lung injury and VAP. Additionally, his spine and
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brain injuries would preclude a number of components of the VAP prevention bundle. It appeared that a subglottic secretion drainage ETT would be his best preventative strategy for VAP. General practice has been to avoid changing an ETT unless this is done in a controlled environment and under optimal conditions. But this was a special case. Using video laryngoscopy, the anesthesiologist had clear visualization of the initial ETT traversing the vocal cords, and felt that it would be safe to change to a subglottic secretion drainage ETT. The tube change to the TaperGuard Evac ETT proceeded uneventfully. The patient progressed through a 6-week ICU stay, complicated by acute lung and kidney injury, abdominal compartment syndrome, and inanition. With regard to VAP prevention measures, he was not amenable to sedation hold, was too edematous to implement oral care, and chemical deep venous thrombosis prophylaxis was contraindicated for the early portion of his ICU stay. Secondary to severe acute respiratory distress syndrome, he underwent a prolonged period of pharmacologic paralysis and rotation therapy. This precluded elevation of the head of the bed for multiple weeks. But at the time of his tracheostomy 3 weeks after injury, minimal secretions had accumulated above the ETT balloon and, most importantly, he did not contract VAP. Although the decision to change the ETT during the initial laparotomy was difficult, the subglottic secretion drainage may have contributed to the lack of pneumonia in this highrisk patient.
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50. Van den Brande F, Mulier J, Dillemans B. Tracheal cuff leak in morbid obese patients intubated with a taperguard or a hi-lo cuffed endotracheal tube evaluated by bronchoscopy [19AP2-9]. Eur J Anaesthesiol. 2010;27(47):250. 51. Miller MA, Arndt JL, Konkle MA, et al. A polyurethane cuffed endotracheal tube is associated with decreased rates of ventilatorassociated pneumonia. J Crit Care. 2011;26(3):280-286. 52. Flores T, Borg U. Effect of endotracheal tube with taper shaped cuff and subglottic secretion (SGS) suction port intubation days in an urban ICU. Presented at the 2011 Critical Care Congress of the Society of Critical Care Medicine; January 16, 2011; San Diego, CA. Abstract 343.
Disclaimer: This monograph is designed to be a summary of information. While it is detailed, it is not an exhaustive clinical review. McMahon Publishing, Covidien, and the authors neither affirm nor deny the accuracy of the information contained herein. No liability will be assumed for the use of this monograph, and the absence of typographical errors is not guaranteed. Readers are strongly urged to consult any relevant primary literature. Copyright © 2012, McMahon Publishing, 545 West 45th Street, New York, NY 10036. Printed in the USA. All rights reserved, including the right of reproduction, in whole or in part, in any form.
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Disclosures: Dr. Bent reported that she has received research funding as a principal investigator from Covidien. Dr. Toschlog reported that he is on the speakers’ bureau for Covidien.