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Letter to the Editor:
Closed Claims Study
J.P. Abenstein, MSEE, MD President American Society of Anesthesiologists
Respiratory Depression Injuries Overwhelmingly Preventable
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read with interest the article by Robert E. Johnstone, MD, concerning membership in the American Society of Anesthesiologists (ASA) (“ASA Membership: Some Say No,” April 2015, page 1). There is no question that all medical societies, including the ASA, struggle to grow membership. In my view, the issue boils down to the value of membership. Put another way, what do our physician members get in return for their hard-earned dollars for ASA membership each year? Every one of our members
espiratory depression (RD) often strikes patients within 24 hours of surgery and causes death or brain damage in the most serious of these cases, yet these injuries are often preventable, a new study from the Anesthesia Closed Claims Project and Anesthesia Quality Institute found. More than 88% of the RD events that led to malpractice cases occurred within 24 hours of surgery, with 77% resulting in severe brain damage or death, according to a report in Anesthesiology
see ASA page 14
see RD page 7
‘Put the Phone Away, You Are Having an Operation’ 6 Peter J. Papadakos, MD, FCCM, FAARC
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ny visitor to a modern hospital or health facility will quickly observe that patients, families and visitors are looking into the glow of the box in their right hand. They exercise their thumb with rapid motion on the screen, texting and shuttling between social media posts. The press is full of how this nowknown addiction has affected the human condition. There are thousands of deaths and injuries attributed to distracted driving and walking, and horrible reports
of individuals jumping in front of subways to “rescue the phone.” It is common knowledge that many teens believe theirr life is on the phone and they could not live without it. As one who has observed how such uncontrolled technology use affects health care providers and helped coin the term “distracted doctoring,” I have begun to study how this dependency on what I term “personal see hang up page 13
CLINICAL ANESTHESIOLOGY
Failure to reverse neuromuscular blockade increases reintubation risk sixfold.
22
CLINICAL ANESTHESIOLOGY
Identifying, communicating and managing patients designated as “difficult to intubate.”
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COMMENTARY
Is the U.S. health care system really the best?
15
COMMENTARY
Follow-up: Welcome change comes to MOCA
16
CME: PREANESTHETIC ASSESSMENT
Lesson 316: Management of the Patient With Amniotic Fluid Embolism
EDUCATIONAL REVIEW Current and Emerging Technology In Anesthesia, see insert at page 12.
ffor iPad see page 4
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Preoperative Fasting in Children Unnecessarily Prolonged
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The Storm Abroad: Anesthesiology During Wartime
FDA Approves IONSYS Fentanyl Delivery System for Acute Post-op Pain
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Tweets of Interest #anesthesianews (From the annual ASRA Regional Anesthesiology and Acute Pain Medicine Meeting) Anesthesiology News @anesthesianews In intraplexus approach, there is a 11.5% chance that the needle tip position may be sub-epineurial. Abs. 282 #ASRASpring15 #anesthesianews
AHC Media @SameDaySurgery In response to ‘global crisis,’ Global Alliance for Surgical, Obstetric, Trauma & Anaesthesia Care (G4) launched http://bit.ly/1FmlYlb
Anesthesiology News @anesthesianews Preop, rather than periop, air warming in THA significantly lowered post op shivering, periop blood loss #anesthesianews #ASRASpring15
Mark Ryan @RichmondDoc “Every surgeon carries within himself a small cemetery, where from time to time he goes to pray.” — René Leriche http://nyr.kr/1IwjFht
Anesthesiology News @anesthesianews Unplanned readmission post outpatient ortho surgery using peripheral nerve blocks has high rate. Abs. 304 #ASRASpring15 #anesthesianews
Government Health IT @GovHIT Medical device security vulnerabilities prompt FDA alert http://ow.ly/N8FYV
ROBERT S. LAGASSE, MD, New Haven, CT
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JUNE 2015
AnesthesiologyNews.com I 5
CLINICAL ANESTHESIOLOGY
Lorazepam Not Linked to Higher Postoperative Satisfaction
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atients given a common antianxiety drug before general anesthesia scored no better after surgery in terms of overall satisfaction than those who received no premedication, a French study concluded. Patients dosed with lorazepam also took longer to fully recover cognitive function and required more time for extubation, according to the PremedX study, which was published in the Journal of the American Medical Association (2015;313:916-925). Even highly anxious patients who were sedated before general anesthesia fared no better after surgery on a validated patient satisfaction survey than others with the same profile who received no premedication, according to the study, which was led by Axel Maurice-Szamburski, MD, of the Hopital de la Timone Adulte, in Marseille. The French National Hospital Program of Clinical Research funded the study. “The findings suggest a lack of benefit with routine use of lorazepam as sedative premedication in patients undergoing general anesthesia,” the researchers concluded. In an interview with Anesthesiology News, Dr. Maurice-Szamburski said the study is a significant advance because there is a dearth of research on sedative premedication, despite its wide use by anesthesiologists. “There are few studies about sedative premedication,” he said. “This is one of the first to explore sedative premedication with a validated satisfaction scale.” The PremedX study consisted of 1,062 randomly assigned adults, in five French teaching hospitals, who had elective surgery between January 2013 and June 2014. Patients undergoing neurosurgery or obstetric, cardiac or outpatient surgeries were excluded. Approximately one-third of the patients were given lorazepam (n=330), another one-third received a placebo (n=322), and the rest received no premedication (n=319). To accurately gauge patient satisfaction after surgery, Dr. MauriceSzamburski and his team developed and validated two new tests. The Evaluation du Vecu de l’Anesthesie Generale (EVAN-G) measures the patient experience based on expectations for general anesthesia, and the Evaluation du Vecu de l’Anesthesie LocoRegionale scores the patient experience based on expectations for regional anesthesia.
The EVAN-G rates patient satisfaction on a scale of 0 (worst) to 100 (best). In terms of overall patient satisfaction, the no-premedication group scored 73, followed by the lorazepam group with 72 and the placebo group with 71 (P=0.38). Similar results were found for the most anxious patients, all of whom scored 11 or greater on the Amsterdam
55 50 45 40 35
60
30
Preoperative Anxiety and Information Scale. Among patients with heightened preoperative anxiety, the lorazepam group scored slightly lower (68) on the EVAN-G scale than the nopremedication group (73) or the placebo group (70), the study found, although the differences were not significant (P=0.18).
5
Lorazepam was associated with some negative secondary effects, the study concluded. More than 71% of patients who received no premedication fully recovered cognitively 40 minutes after the conclusion of anesthesia, whereas 64% of those who received placebo recovered within that period. By comparison, 51% of the see lorazepam page 6
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CLINICAL ANESTHESIOLOGY
Failure To Use Reversal Agent Ups Reintubation Risk Sixfold Honolulu—Although man ny anesthesiologists do not routinelyy reverse neuromuscular blockade at the t end of surgery, a study has found that patients who are left to spoontaneously recover from such blockade are six times as likely to need reintubation within 48 hours of surgery as their counterparts who receivved a reversal agent. Of the modiifiable risk factors evaluated in the moodel, the failure to use a reversal agent appeared a to have the strongest influence on early risk for reintubation. “Every institution experiences unplanned tracheal intubations in the early postoperative period, which are rare but potentially catastrophic events. At the time of tracheal extubation, full recovery of muscle strength should be present, and the residual effects of intraoperative anesthetic agents resolved,” said Glenn S. Murphy, MD, clinical professor of anesthesiology at the NorthShore University Health System, in Chicago, and the University of Chicago’s Pritzker School of Medicine. “Obviously, there are patient factors that come into play, but how we manage patients in the operating room may also contribute to the risk of a patient being reintubated.” The risks associated with unplanned reintubation have been well documented, and include increased postoperative morbidity and mortality. A 2012 analysis (BMJJ 2012;345:e6329)
LORAZEPAM
‘I think tthese data support the idea that neuro neuromuscular blockade should be ro routinely reversed in patients who receive nondepolarizing muscle relaxants.’ —Glenn S. Murphy, MD
found th hat reinrequirtubation ing admission to the ICU was associated with a 90-fold higher risk for in-hospital mortality. “Those findings suggest [that] strategies to optimize respiratory muscle strength prior to extubation may reduce mortality,” Dr. Murphyy said. To determine the factors associated with the need for reintubation after surgery, the investigators reviewed the Premier hospital database, which contains information on all hospital visits to any Premier system hospital, to identify patients who underwent general or vascular surgery and were discharged between Jan. 1, 2012 and Dec. 31, 2013. Reintubations occurring at any time during the hospital stay were identified, and potentially related risk factors were examined. Multivariate models were then developed to assess adjusted risks for reintubation based on those factors. As reported at the 2015 annual meeting of the International Anesthesia
Research Society (abstract S-304), the study found that 7,152 of 557,592 patients analyzed were reintubated (1.3%). Of these, 2,343 (0.42%) occurred within 48 hours of surgery. “It’s possible that anesthetic management factors may have played a contributing role in reintubations that occur within 48 hours of surgery,” Dr. Murphyy said in an interview with Anesthesiology News. The multivariate analysis found that the strongest associations with reintubation at any time after surgery were trauma versus elective surgery (relative risk [RR], 6.04; 95% confidence interval [CI], 4.22-8.66), a diagnosis of sepsis (RR, 7.70; 95% CI, 7.23-8.20), pneumonia (RR, 3.78; 95% CI, 3.54-4.05), hemiplegia (RR, 3.25; 95% CI, 2.80-3.78) and the use of a neuromuscular blocking agent without a reversal agent (RR, 3.96; 95% CI, 3.68-4.25). —Michael Vlessides When the researchers focused their analysis on the first 48 hours after sur- Dr. Murphy disclosed that he is on the advisory gery, they found that the RR for rein- board for Merck, and also acts as a speaker for tubation was greatest among patients the company.
reporting lower levels of satisfaction in terms of waiting time for visits from the anesthesiologist and lorazepam group recovered cognitively within 40 surgeon. The sedative also affected pain scores after surgery, minutes (P<0.001). Additionally, an average of 17 minutes was but only compared with the placebo group. Patients required to extubate the lorazepam patients, com- who received the drug scored about the same as the pared with 12 minutes for the no-premedication no-premedication group, but both did better than group and 13 minutes for the placebo group the placebo group, raising the possibility of a nocebo (P<0.001). The lorazepam group was also more effect in the placebo group. likely to experience sleep problems after surgery, “One interpretation of these results is that a according to the study. patient’s amnesia for pain is beneficial, whereas not The lorazepam group was significantly more likely remembering the attention provided by caregivers to report amnesia (24%) than no-premedication and adversely affects the overall perioperative experience,” placebo patients (6% for both; P<0.001). Patients the researchers concluded. who received lorazepam were also less satisfied with While only lorazepam was tested, the findings are the attention they received from caregivers, scoring likely to have relevance for a whole class of benzodi74, compared with 77 in the no-premedication group azepines, Dr. Maurice-Szamburski said. and 75 in the placebo group. But the lorazepam Dr. Maurice-Szamburski said his team found, in group likely did not receive less care, they just didn’t a subgroup analysis, that patients who experienced remember it later, Dr. Maurice-Szamburski noted. anxiety the day before surgery, as opposed to the Patients who received the anti-anxietyy drug also day of surgery, had lower overall satisfaction scores exhibited higher levels of impatience after surgery, after their operations. While calling the finding CONTINUED FROM PAGE 5
undergoing trauma surgery (10.51; 95% CI, 6.61-16.73), followed by those who received a neuromuscular blocking agent without reversal (RR, 6.02; 95% CI, 5.35-6.78). The RR for reintubation on postoperative day 3 was greatest among patients with sepsis (12.32; 95% CI, 11.26-13.48) and pneumonia (4.26; 95% CI, 3.88-4.68). “I think these data support the idea that neuromuscular blockade should be routinely reversed in patients who receive nondepolarizing muscle relaxants,” Dr. Murphyy said. “I think that’s been the opinion of many experts in the field for a long time. Even so, a large percentage of anesthesiologists do not routinely reverse. “Recovery times from most nondepolarizing neuromuscular blocking agents can be extremely variable and affected by a number of factors,” he added, “so we can’t really identify who the outliers are going to be. Because of that—unless you have quantitative monitoring —I think that we’re obligated to reverse patients. In fact, I think the only time you shouldn’t reverse neuromuscular blockade is if you have a quantitative monitor, like a TOF [train of four]-Watch , that tells you that muscle function has fully recovered.”
“exploratory,” he said it pointed to the potential benefit of identifying and treating anxiety earlier in the process. Previous studies “have established a link between preoperative anxiety and the development of posttraumatic stress disorder, reinforcing the notion that patients prone to preoperative anxiety should receive specific attention,” the researchers noted. Further research is also needed to examine alternative ways to increase overall patient satisfaction given the issues raised by premedication sedation, Dr. Maurice-Szamburski said. The study’s findings highlight the importance and potential of patient-centered care in improving the overall patient experience, he said. “We have to discuss what could improve the patient experience,” he said. “When you analyze this, the most important determination of the patient experience is the attention you give to patients.” —Scott Van Voorhis The researchers reported no relevant financial disclosures.
JUNE 2015
AnesthesiologyNews.com I 7
CLINICAL ANESTHESIOLOGY RD
This study’s proposed interventions are based on an in-depth analysis of (2015;122:659-665). Top causes were cases identified as RD, as well as the multiple physicians prescribing pain factors that too often resulted in serimedications for the same patient, the ous brain injury or death, the researchlayering on of sedatives atop opioid- ers noted. “Careful review of rare based medications and inadequate sentinel events is one method to idenresponses or assessments by clinical tify causal factors that, if modified or staff. eliminated, could prevent undesirable outcomes,” the researchers said. In one of its key recommendations, ‘It becomes confusing the study urged hospitals to coorif the surgeon or other dinate clinicians prescribing pain CONTINUED FROM PAGE 1
medications during the postoperative period. In at least one-third of the malpractice claims analyzed, more than one physician prescribed opioidbased pain medication for the same patient. Issues related to the administration of opioid-based pain medications have previously been flagged in recent studies as a major driver behind RD. Ideally, all prescriptions for opioidbased pain medications should go through one physician, Dr. Lee said.
physician writes for an opioid medication postoperatively, but the doctor in charge of the pain service is not aware of it.’
Multiple Opioid Scripts The study examined 357 acute pain cases from the Anesthesia Closed Claims Project, which includes records on 9,799 malpractice claims from hospitals across the country. The study found that RD was possible, probable or definite in 92 of the claims. The issue of RD has drawn increasing attention over the past few years, with recommendations for improving patient safety emanating from the Joint Commission, the Institute for Safe Medication Practices and the Anesthesia Patient Safety Foundation.
see RD page 8
WHEN PERFORMANCE MATTERS MOST,
—Lorri A. Lee, MD
However, the overwhelming majority of cases—97%—were judged to have been preventable if there had been better monitoring of the patients or a more adequate response once RD was identified, according to a team of researchers affiliated with the Anesthesia Closed Claims Project. The researchers recommended tighter controls over the prescription of sedatives and opioid-based pain medication, better training of clinical staff in assessing the signs of RD and more effective postoperative monitoring of patients who are prescribed opioids. “It becomes confusing if the surgeon or other physician writes for an opioid medication postoperatively, but the doctor in charge of the pain service is not aware of it,” said Lorri A. Lee, MD, the lead author and professor of anesthesiology and neuroanesthesiology at Vanderbilt University Medical Center, Nashville, Tenn.
“If they feel the patient needs additional pain medication, they should contact the pain service or other physician in charge of prescribing opioids for the patient,” she said. Hospitals also need to coordinate the use of “nonopioid sedative medications in patients who are receiving opioids in a similar fashion,” the study noted. In one-third of the cases, patients receiving opioid-based pain medications were also prescribed sedatives.
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One of the “definitive” signs of RD includes the combination of oversedation, respiratory arrest and the need for resuscitation. Hospitals and medical centers across the country need to consider “institutional policies that discourage, limit or prevent more than one opioid-prescribingg physician,” the researchers noted. Monitoring Faulted Meanwhile, more also needs to be done to monitor at-riskk patients more closely and to train clinical staff to identify the signs of RD early on. In 31% of the closed claims examined, nursing checks were found lacking. The nurses in these cases did not recognize that clinical signs, such as “somnolence and/or oxygen desaturation,” are signs of RD. Also, nurses sometimes did not check their patients frequently enough, thereby missing the opportunity to intervene. An example is given of an obese man in his 40s who was described after surgery as snoring loudly, slow to rouse and sleepy. After his oximeter read 49%, oxygen was replaced and his reading improved to 93%. Without speaking to a doctor, the nurse then left to do her rounds, noting the patient was “without complaints.” The patient was apneic within 28 minutes and died a few days later of anoxic brain injury. “These findings suggest a need for repeated careful assessments postoperatively and increased education regarding signs of opioid toxicity, including the correlation between ventilatory depression and excessive sedation,” the study noted. Yet although closer monitoring of patients at risk for RD is needed, how to accomplish this is another question, given the sometimes extremely rapid onset of the potentially fatal condition. In a dozen of the malpractice cases analyzed in the study, RD occurred within 15 minutes of a nursing check. “It is not possible for nurses to be able to
be in the room that much given the way we currently staff nurse-to-patient ratios,” Dr. Lee said. Given the realities of staffing in modern health care, a growing number of hospitals are turning to electronic monitoring of all patients, not just those at risk, to prevent RD. Yet the effectiveness of some of the monitoring systems is highly questionable, the study noted. Basic pulse oximetry monitoring was being used in at least one-third of the malpractice claims involving RD, Dr. Lee and her fellow researchers wrote. The missing link, the researchers noted, was the lack of centralized or telemetric alarms, which could have altered outcomes by providing effective alerts to nurses and physicians. “If you have an electronic monitoring system, it needs to have an alarm that is sent to a care provider,” Dr. Lee said. Even so, there are a number of barriers to the wider rollout of this combination of continuous electronic monitoring with a centralized alarm system. It can be difficult to get nurses and doctors to adopt the new technology; alarm fatigue may make the alarms less effective; and concerns about interrupting the sleep of patients are potential obstacles. Simply finding the money to acquire and install an expensive monitoring alarm system can be difficult as well. Even so, the potential gains outweigh the costs, the study concluded. “These and other data support a more comprehensive monitoring and response approach to prevent what are considered to be avoidable devastating events,” the researchers concluded. —Scott Van Voorhis One of the study’s authors, Karen L. Posner, PhD, a research professor in the Department of Anesthesiology & Pain Medicine at the University of Washington School of Medicine, received a two-year, $10,000 grant from the Society of Anesthesia and Sleep Medicine. There were no other conflicts of interest reported by the study’s research team.
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JUNE 2015
AnesthesiologyNews.com I 9
CLINICAL ANESTHESIOLOGY
Low Rates of Unplanned Admissions After Ambulatory Surgery Demonstrate Good Planning and Cooperation Honolulu—A quality control audit at an orthopedic ambulatory surgery center in New York City revealed low rates of unplanned admissions after surgery. That success, investigators concluded, is the product of an anesthesiology-led screening clinic and friendly collaboration between anesthesiologists and surgeons. “We’re always interested in patient outcomes and need to improve our care,” said Germaine Cuff, PhD, director of quality assurance and outcomes analysis in New York University Langone Medical Center’s Department of Anesthesiology. “As part of that, we always have to do quality control. We have a freestanding orthopedic ambulatory surgery center that’s about four blocks away from our primary hospital, and we wanted to get an idea of how things are going there.” Such analyses are important given that the surgical center is not physically attached to the tertiary care hospital. While this structural model may allow for streamlined surgical care of ambulatory patients, outpatient centers are typically ill equipped to handle many postoperative complications, which ultimately necessitates emergency transfer to the hospital and greatly increases the cost of surgical care. “Before the advent of our orthopedic ambulatory surgery center, all outpatient surgery was performed in the hospital,” Dr. Cufff said. “Yes, most patients were discharged on the same day, but we had the luxury of a critical care team available if something went wrong. We don’t have that luxury at the outpatient center. If we’re not benefitting patients by having the center removed from the hospital, then why have it?” To help answer that query, Dr. Cuff and her colleagues reviewed the medical records of patients undergoing orthopedic surgery at the center between March 2010 and February 2014. Data from patients requiring unplanned admission to the inpatient hospital were recorded, and each case was analyzed to determine the reason for admission as well as actions taken by ambulatory surgery and hospital staffs. As Dr. Cufff reported at the 2015 annual meeting of the International Anesthesia Research Society (abstract S-22), only 37 of 15,471 patients were
admitted to the hospital from the ambulatory surgery center (incidence, 2.4/1,000). “I think we’re doing a fantastic job,” she told Anesthesiology News. “Then again, in three more years we’ll have to reassess because our patient population changes every year. It used
to be that hypertension and diabetes were serious diagnoses. Now, those are considered healthy patients.” Among patients admitted to the hospital, the average body mass index was 27.1. Seventy-three percent of cases involved general anesthesia, with
N W
or without a regional block. Asthma and diabetes were the most common comorbidities, each of which was present in three patients. Twenty-three percent of admitted patients were classified as physical status ASA I, while see readmits page 10
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10 I AnesthesiologyNews.com
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CLINICAL ANESTHESIOLOGY READMITS
anesthesiologist-run preadmission clinic and exerthe remainder were ASA II; none was cise tight controls on where ASA III or greater. The most common our patients go once they reasons for transfer were pulmonary go through preadmission problems (24%), cardiac issues (24%) testing,” she explained. “So, and postoperative pain (13.5%). None if we have any reason to of the medical issues causing admission believe that a patient needs extra monitoring, then we were preexisting conditions. As Dr. Cufff discussed, achieving don’t recommend they be such a low rate of unplanned admis- seen in the outpatient cen- Germaine Cuff, PhD sions is largely the product of success- ter. We have the luxury ful patient screening. “We have an of picking the healthiest CONTINUED FROM PAGE 9
patients for the outpatient center.” However, this did not help clinicians predict which outpatients might end up being transferred down the road. “The patients we admitted were not those that we would have necessarily predicted to be admitted,” she noted. “That was the conundrum: The patients who were
Now protect your hard-earned reputation from cyber-attack. Since 1987, Preferred Physicians Medical (PPM) has exclusivelly insured anesthesiologists and their practices. Our policyholders also own PPM, so helping our physician owners manage their risk is a cornerstone of wh hat makes us unique.
admitted weren’t those that we otherwise would have predicted. They were ASA class I and II individuals with no prediagnosed disease. But they did, nevertheless, have respiratory and cardiac issues.” Either way, a collegial relationship and open communication between anesthesiologists and their surgical colleagues went a long way toward optimizing patient outcomes. “I think a lot of our success has to do with the surgeons and the anesthesia staff having such a great relationship,” Dr. Cufff suggested. “Collaboration is what makes us successful. “I think that the lesson learned here is that nothing in health care is a breeze,” she concluded. “We always have to pay attention and be diligent with our assessments.” —Michael Vlessides The researchers reported no relevant financial relationships.
Letter to the Editor: read with initial interest the article about the perioperativists (“The ‘Perioperativists’ Are Coming”; March 2015 issue, page 14). The article by Dr. Frederickk L. Greene was interesting and mostly accurate, until the last line where it states that the surgeon must always be “captain of the ship!” I was shocked to read this in a paper geared towards anesthesiologists. First of all, surgeons have not been “captains” of the ship for years. They gave that up when willingly or unwillingly we anesthesiologists had to step up. As initiatives from the ASA, such as the perioperative surgical home and the ERAS protocols, begin to take hold in the US it will once again be the anesthesiologists who take charge. The days of the quiet unsung heroes of the operating room are over. We anesthesiologists are once again stepping up to do what must be done to better care for our patients, while our surgical colleagues do what they do best—perform surgery. And together, through teamwork and mutual respect, we will improve outcomes for our patients.
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One emerging risk for anesthesiologists is the rise in unauth horized disclosure of personal health information (PHI) from high tech data breaches and security lapses in dealing with patient records, both electronic and paper. As of 1/1/2015, all PPM policyholders receive standard Cyber Liability Covverage at no additional charge, with no underwriting required or deducctibles applied.* Additional coverage tailored to your practice is also availab ble. PPM also maintains a substantial database of more than 122,500 adverse anesthesia events and uses this information to identify areas of risk, monitor developing loss trends, and provide cutting-edge, timely an nd practical anesthesiaspecific risk management advice and strategies like: On-site risk management seminars for policyholderrs and staff presented by PPM in-house in house claims attorneys attorneys. Immediate email notification via Anesthesia Alertss of important, time-sensitive issues such as widespread drug contamination and significant changes to ASA Standards. 24/7/365 telephone access to our experienced attorn neys and claims specialists for the expert risk management advice you need. Exclusive access to anesthesia specific practice and risk management resources. Examples include white papers, sample in nformed consent documents, current and archived issues of Anesthesiia & the Law, w and other useful information for your practice.
Michael J. Peck, MD Rockville, Maryland *In partnership with NAS Insurance, the leading provider of Cyber Liability Coverage to health care professionals in the United States.
Add your good name to our growing list of ASA “standard of care” clinicians. Call us toll free today at 800.562.5589 and join other select anesthesiologists who have already secured ownership in their professional reputations. 9000 West 67th Street
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Editor’s note: The comments by Dr. Greene were what they were, and we would never edit comments if for some reason we do not agree with them. We endeavor to be impartial.
JUNE 2015
AnesthesiologyNews.com I 11
COMMENTARY
The U.S. Health Care System: Really the Best? Samuel Metz, MD
I
n his opinion piece (Anesthesiol( ogy News 2015;41[February]:44), Dr. S.J. Slavin takes the proverbial ax to the tree of American health care reform. And he wields it with gusto. Two assumptions animate his swing and both deserve careful attention: 1) Despite its flaws, our U.S. health care system is better than any other, and 2) foreign nations have nothing to teach us. Such patriotic vigor is understandable. After all, America gave the world Elvis Presley, footprints on the moon and the oil depletion allowance. With such achievements, why shouldn’t we think of ourselves as world leaders in health care? Unhappily, our success in rock ’n’ roll, technology and finance does not translate to health care. Americans pay twice as much as citizens in the average industrialized nation—our health
care is the most expensive on earth. Yet our public health is a disgrace. There are 60 other countries where a pregnant woman and her baby have better chances of surviving the pregnancy.1 American diabetics are more likely to suffer a foot amputation from an untreated ulcer than are diabetics living anywhere else where you can drink the tap water.2 Our infant mortality rates are the highest in the civilized world, as Dr. Slavin noted, even when comm pared only with other nationss that tha th that, hat h at a ass Dr. Slavin wrote, do not throw out premature babies and label them “miscarriages.” Our life expectancy ranks 30 to 35 in the world, even after correcting for trauma, traffic accidents, racial disparity and smoking.3 And each year, 44,000 Americans die of treatable diseases because they lack money for treatment.4 Patients in other countries might wait for elective treatment, but
Americans might very well die before they get essential treatment. There’s no wait time longer than the rest of your life. Adding insult to the injury of expensive care and dismal outcomes iss th tthat h t medical med me m ediccal al deb de debt eb is the hee leading l ading addingg cause ca c use se of of personal ba k up ba bankruptcy uptc p c in ptc n tthe th he Un United Uni United States. Most M oost os st ooff th st tthose h e ba ho bbankrupt ban ank an ank n rup rupt ru uupt ptt fami fa families owned an n iinsurance in anc an nce nc n ce policy ppoll when the medical crisi cr cri crisis risis isis iiss bbe began began— ega gan ga ggan— an so much for insurance nc policies nce pol pol olicies icie ies protecting access to health llth h care ca care. ccar aare re. e.5 A further insult is that “medical dica dical di dic cal all bankruptcy” is an exclusively Amermerrican disease. In no other country will you lose your home, your foot or your life if you can’t pay for health care. Our results look bad even when
compared only with foreign nations that don’t impose government control on health care (most of them don’t). Socialized medicine or not, every other industrialized nation provides better care to more people for less money than we do. In spite of Dr. Slavin’s caution to turn our backs on these alien, socialist, non-American solutions, we should still pay attention. Universal Health Care? The common characteristic of nations with better results at less cost is a universal health care plan. Regardless of how it’s implemented, the administrative efficiency of universal care more than compensates for the added costs of more benefits to more people. see best? page 12
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COMMENTARY BEST?
CONTINUED FROM PAGE 11
Example: UnitedHealthcare provides private insurance to 24 million Americans, most of them healthy enough to hold steady jobs and wealthy enough to afford high-end policies. The company spends almost 20%6 of its premium dollars paying for 37,000 administrators.7 In contrast, Taiwan’s national health care service, which also cares for 24 million people (employed and unemployed, sick and
healthy, rich and poor), spends 1% of its premium dollars paying for 2,900 administrators8—a 90% reduction in administration, enabling the health service to provide comprehensive coverage to 100% of the population. In fact, no nation on earth spends more money than we do on health care administration, nor requires as many administrators, nor loses as much money filtering its premium dollars through insurance companies as we do. This administrative loss doesn’t
include the administrative losses of we physicians who spend $82,000 a year— each—desperately attempting to collect our payment from an insurance industry that denies 30% of all first claims.9 Parenthetically, Dr. Slavin mentions Danny Williams, the wealthy premier of Labrador, who flew to Miami for his mitral valve repair rather than stay in Canada. This story is instructive. Mr. Williams’ first option included Canadian hospitals in Ottawa and
Toronto that specialize in the operation. He could then have his operation performed at public expense immediately by surgeons who enjoy international reputations. However, Mr. Williams consulted a college friend in New Jersey who recommended a surgeon in Miami. Miami had the advantage of being close to Mr. Williams’ vacation condominium in Sarasota. Mr. Williams opted to have his operation performed by a less experienced surgeon in another country at his own expense. The operation took twice as long as expected, but Mr. Williams did just fine. He recovered uneventfully at his nearby condo. This story may or may not reflect quality of health care in the two countries. But it certainly illustrates, as Dr. Slavin might agree, that wealthy people sometimes make medical decisions based on convenience, word-off mouth and other nonmedical factors, just like the rest of us. We all share Dr. Slavin’s frustration at the hideous complexity and injustice of our country’s health care system. Yet our despair should not blind us to the single most important lesson that other industrialized nations with better systems (i.e., all of them) can teach us: Start with a universal care plan, and build on that. Health care reform does not need to be the terrifying specter that Dr. Slavin warns against. It can be the first step toward better care to more people for less money. A tree bearing that kind of fruit deserves nurturing, not the ax. References 1. Kassebaum NJ, Bertozzi-Villa A, Coggeshall MS, et al. Global, regional, and national levels and causes of maternal mortality during 1990-2013: a systematic analysis for the Global Burden of Disease Study 2013. Lancet.t 2014;384(9947):980-1004. 2. Health Care at a Glance 2009: OECD Indicators. http://www.oecd-ilibrary.org/sites/ health_glance-2009-en/05/02/02/index. html?contentType=&itemId=/content/chapter/ health_glance-2009-49-en&containerItemId=/content/serial/19991312&accessItemIds=/content/ book/health_glance-2009-en&mimeType=text/html. Accessed May 11, 2015. 3. Muenning PA, Glied SA. What changes in survival rates tell us about US health care. Health Aff. 2010;29(11):1-9. http://content.healthaffairs.org/ cgi/content/abstract/hlthaff.2010.0073v1. Accessed May 11, 2015. 4. Wilper AP, Woolhandler S, Lasser KE, et al. Health insurance and mortality in US adults. Am J Public Healthh 2009;99(12):2289-2295. http://www.ncbi. nlm.nih.gov/pmc/articles/PMC2775760. Accessed May 11, 2015. 5. Himmelstein DU, Thorne D, Warren E, et al. Medical bankruptcy in the United States, 2007: results of a national study. Am J Med. 2009;122:741-746. 6. Committee on Commerce, Science, and Transportation. Office of Oversight and Investigations,
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COMMENTARY HANG UP
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technology” affects the professional– patient relationship. We all know the complaints that patients have that their provider is too fixated on the electronic health record and is not interacting with the living patient, but with the socalled i-patient that is in the computer. Medical schools and medical societies are addressing so-called technology– human interactions and professional etiquette, but a new problem looms: the patient who does not interact with the provider. Patients can thus affect their care based on their distraction. As an illustration, I will give several patient scenarios that I have observed. A young teen struck by a car and awaiting surgery is too busy taking selfies in her hospital bed. Both parents are on their own personal electronic devices, one texting, the other posting on Facebook. When the anesthesiologist tries to get a preoperative history and share his anesthesia plan with them, he is cut off with the statement, “Do you not see I am texting? Do not interrupt.” This scenario is becoming more and more common in our society and illustrates a fact, that has been identified by neuroscientists, that the individual is so engaged with the technology that the actual event eludes them. This electronic escapism has been identified many times by texting drivers who have no recall of the accident after the fact. This psychological response can truly endanger the professional relationship because patients may not remember all-important information transmitted to them by the bedside staff—this information is just not processed. This lack of engagement may also decrease the amount of medical history or data that the patient or their families volunteer. They are too
Majority Staff. Implementing health insurance reform: New medical loss ratio information for policymakers and consumers. Staff Report for Chairman Rockefeller, April 15, 2010, Table 1, page 4. 7. http://careers.unitedhealthgroup.com/why-workhere/our-businesses/unitedhealthcare-employerand-individual. Accessed May 11, 2015. 8. Cheng TM. Reflections on the 20th anniversary of Taiwan’s single-payer national health insurance system. Health Aff.f 2015;34(3):502-510. 9. Furhmans V. Fights over health claims spawn a new arms race. Wall Street Journal. February 14, 2007: A1. https://www.ppocheck.com/fightsOverHealthClaims.htm. Accessed May 11, 2015.
Dr. Metz is a private practice anesthesiologist in Portland, Ore. He is a member of Physicians for a National Health Program (http://www.pnhp.org) and a founding member of Mad As Hell Doctors, both of which advocate for universal health care.
engaged in hypersocial interactions with distant virtual worlds to think about the importance of the here and now. Repeatedly, we also see a new phenomenon in which the patient has become the i-patient and depends on technology to know their own information. Such interactions can be as simple as the answer to the question, “What medications are you on?” with the now common answer, “I do not know, it’s on the computer.” This would be all fine and good if there
were a uniform electronic medical record shared by all that is always complete, but we all know that is not the case. There are other factors, such as spurious information being present in electronic records and incorrect information about medical history and current medications, all of which may greatly affect the care of the patient. As an active clinician, I can tell you I am confronted daily with false information in these records that might have affected patient care if I had not
verbally reviewed the information with the patient and corrected it. How can we, as health professionals, begin the battle to regain the sacred bond between the patient and the practitioner, which has been at the core of medical practice since the ancient Greeks? I believe we need to educate the public about how this dependency on technology has affected them. Physicians should take the lead on how texting and social media addiction affects health. see hang up page 23
IMPORTANT CORRECTION OF DRUG INFORMATION ABOUT EXPAREL® (BUPIVACAINE LIPOSOME INJECTABLE SUSPENSION) Pacira Pharmaceuticals, Inc., received a warning letter from the US Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) on September 22, 2014 concerning an advertisement for EXPAREL, which you may have seen published in several professional journals. This publication provides important corrective information about the false and misleading claim. The FDA stated that the advertisement was false or misleading because it overstates the efficacy of EXPAREL. The FDA objected to the claims that EXPAREL provides pain control that lasts for up to 72 hours because the claims suggest that EXPAREL has been shown to provide pain control beyond 24 hours. According to the Prescribing Information, “The primary outcome measure was the AUC [area under the curve] of the NRS [numeric rating scale] pain score (cumulative pain scores) collected over the first 72 hour period.…In this clinical study, EXPAREL demonstrated a significant reduction in pain intensity compared to placebo for up to 24 hours. The difference in mean pain intensity between treatment groups occurred only during the first 24 hours following study drug administration. Between 24 and 72 hours after study drug administration, there was minimal to no difference between EXPAREL and placebo treatments on mean pain intensity.” Excerpts from the applicable sections of the FDAapproved package insert for EXPAREL follow. The FDA has reviewed and approved this communication. Indication for EXPAREL EXPAREL is a liposome injection of bupivacaine, an amide-type local anesthetic, indicated for administration into the surgical site to produce postsurgical analgesia. EXPAREL has not been studied for use in patients younger than 18 years of age. Clinical Studies Hemorrhoidectomy The primary outcome measure was the AUC of the NRS pain intensity scores (cumulative pain scores) collected over the first 72 hour period. There was a significant treatment effect for EXPAREL compared to placebo. ©2015 Pacira Pharmaceuticals, Inc. Parsippany, NJ 07054 PP-EX-US-0623
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In this clinical study, EXPAREL demonstrated a significant reduction in pain intensity compared to placebo for up to 24 hours. The difference in mean pain intensity between treatment groups occurred only during the first 24 hours following study drug administration. Between 24 and 72 hours after study drug administration, there was minimal to no difference between EXPAREL and placebo treatments on mean pain intensity; however, there was an attendant decrease in opioid consumption, the clinical benefit of which was not demonstrated. Important Safety Information EXPAREL is contraindicated in obstetrical paracervical block anesthesia. EXPAREL has not been studied for use in patients younger than 18 years of age. Non-bupivacaine-based local anesthetics, including lidocaine, may cause an immediate release of bupivacaine from EXPAREL if administered together locally. The administration of EXPAREL may follow the administration of lidocaine after a delay of 20 minutes or more. Other formulations of bupivacaine should not be administered within 96 hours following administration of EXPAREL. Monitoring of cardiovascular and neurological status, as well as vital signs should be performed during and after injection of EXPAREL as with other local anesthetic products. Because amide-type local anesthetics, such as bupivacaine, are metabolized by the liver, EXPAREL should be used cautiously in patients with hepatic disease. Patients with severe hepatic disease, because of their inability to metabolize local anesthetics normally, are at greater risk of developing toxic plasma concentrations. In clinical trials, the most common adverse reactions (incidence ≥10%) following EXPAREL administration were nausea, constipation, and vomiting. Reporting Adverse Events Heath care providers and patients are encouraged to report adverse events in patients taking EXPAREL to Pacira at 1-855-793-9727. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. Please see accompanying brief summary of Prescribing Information.
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COMMENTARY ASA
CONTINUED FROM PAGE 1
voluntarily joins ASA. The Society clearly recognizes this dynamic and has focused resources to substantially increase its value. And this finer focus on value is working. As of today, 90 percent of ASA’s active members have renewed and active membership has grown 5 percent in 2015. While Dr. Johnstone noted that the issue of nonmembership began about 20 years ago, ASA has worked diligently
to prove its value, and membership growth demonstrates that physician anesthesiologists see the importance of ASA membership. ASA’s five-year growth rate is 18 percent and its 10-year growth rate is 26 percent. A major area of focus for the Society has been ASA’s educational offerings. While we have many continuing medical education opportunities, how a physician wishes to participate in CME is changing. Additionally, the requirements to successfully navigate
the American Board of Anesthesiology’s (ABA) Maintenance of Certification in Anesthesiology (MOCA) requirements are substantial. Many of ASA’s CME activities that provide MOCA credit, including meetings and online education, are automatically sent to ABA. Our online Learning Center offers a number of products that fulfill ABA requirements. ASA has substantially expanded these offerings with the addition of modules focused on patient safety, pediatric
EXP-AP-0020-201301
anesthesia, critical care and so on. Importantly, these education modules are very cost-effective. For example, the ASA Anesthesiology Continuing Education (ACE) program is a selff studyy CME program that can earn up to 60 CME credits per year. It is available as a booklet, an iPad app or online, and costs members less than $400. Now that the ABA has updated their requirements for MOCA 2.0, ASA will update our education offerings accordingly. ASA intends to remain the preferred provider of MOCAcompliant education products. With the current advances in technology that ASA is implementing, our members will be well equipped to meet any new requirements to the current MOCA program. Our goal is to make navigating the MOCA process as easy as possible, while providing the most up-to-date medical content that will allow our members to provide the highest quality and safest medical care to their patients. Five years ago, ASA launched the Anesthesia Quality Institute (AQI) and established the National Anesthesia Clinical Outcomes Registry (NACOR). Participating practices report their practice data to NACOR, and this information can be used for quality improvement, benchmarking and research. Reporting from NACOR and access to its analytic tools is a benefit of membership for all ASA members. Last year, NACOR was designated by the Centers for Medicare & Medicaid Services (CMS) as a Qualified Clinical Data Registry (QCDR). This designation means that practices reporting the appropriate clinical outcome data will fulfill their quality reporting requirements and thereby avoid cuts in their Medicare payments. Reporting through the ASA QCDR, which will be passed on to CMS, is included with membership. These services represent a $1,295 value. ASA is also advancing the Perioperative Surgical Home (PSH) model of care. This integrated model focuses on coordination and management of patients throughout the procedural episode. The goals of PSH are to reduce complications, improve quality of care and patient safety, and reduce costs. The PSH also will position the specialty to deliver care in our changing health care environment, particularly alternate payment models. ASA’s PSH Learning Collaborative supports more than 40 PSH pilot programs throughout the United States. ASA also has made a priority of aggressively reaching out to the
JUNE 2015
AnesthesiologyNews.com I 15
COMMENTARY
Welcome Change Comes to MOCA Thomas Gallen, MD, MPH, and Oren Bernstein, MD
We are very pleased that the ABA has heard the many concerned voices regarding MOCA and has taken sigast month in Anesthesiology nificant steps to improve the program. News, we described a vision for It is a relief to know that MOCA will a reformed MOCA program, no longer intrude into our lives to the in which the examination, manda- degree that the exam and simulator tory simulator session and practice (along with their necessary prep, travel improvement modules were to be and opportunity costs) previously eliminated and replaced by a nonintrusive online module that exposes diplomates to recent important literature (May, ”MOCA Must Change,” page 1). As that piece went to print, the American Board of Anesthesiology (ABA) announced previously unavailable specifics regarding Maintenance of Certification in Anesthesiology (MOCA) 2.0—both the simulator and examination were indeed eliminated, to be effective as of January 2016. The online MOCA Minute application will replace these components.
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public and policymakers. Through research completed recently, we have determined that more than half of Americans do not know that anesthesiologists are physicians. Our “When Seconds Count” campaign aims to resolve this knowledge gap by regularly informing the public and policymakers of the critical role that physician anesthesiologists provide before, during and after an operation or procedure through the delivery of physician-led, high-qualityy and safe medical care. Finally, ASA continues to lead in medical advocacy in Washington, D.C., and at the state and local levels. The portfolio of advocacy is much too long to fit in a letter to the editor, but clearly the ASA responds to challenges to the profession and is determined to represent the interests of our patients and our member physicians. I believe we provide high value to our members and the Society will continue to increase the value of membership. We are one of the few medical specialty societies that have seen a steady growth in membership. In 2008, we had just over 43,000 members; in 2014, we grew to more than 52,000 members. Our goal is to increase the member value so those physician anesthesiologists who are not ASA members will recognize that not joining is a bad business decision.
did. We applaud the ABA for listening to its membership in enacting these reforms. Clearly, this was a giant step in the right direction. Some major concerns we have are not completely addressed by these changes, however. First, the Practice Performance Assessment and Improvement (PPAI) component remains, and
we firmly believe that it too should be completely removed. The American Board of Internal Medicine (ABIM) has imposed a moratorium on its own PPAI MOC component, so there is a clear precedent by another American Board of Medical Specialties (ABMS) member to not mandate proprietary
Securing Airways with a Gentle Touch TaperGuard™ Cuff Technology When it comes to intubation, tools matter. oid tracheal High-volume, low-pressure (HVLP) cuffs were introduced to help avoid damage.1 But do they go far enough? Compared to traditionall HVLP cuffs, ents and reduce newer, taper-shaped cuffs can both enhance fit* across patients pressure impact on the trachea.2 In other words, these new cuffs help you secure airways with a gentle touch. Learn more at Covidien.com/TaperGuard2
* Compared with traditional HVLP cuffs, taper- shaped cuffs can accommodate more trachea sizes and shapes. 1. Seegobin RD, van Hasselt GL. Endotracheal cuff pressure and tracheal mucosal blood flow: endoscopic study of effects of four large volume cuffs. Br Med J (Clin Res Ed). 1984;288(6422):965–968. 2. Li Bassi G, Ranzani OT, Marti JD, et al.. An in vitro study to assess determinant features associated with fluid sealing in the design of endotracheal tube cuffs and exerted tracheal pressures. Crit Care Med. 2013;41: 518–526. COVIDIEN, COVIDIEN with logo, Covidien logo and positive results for life are U.S. and internationally registered trademarks of Covidien AG. Other brands are trademarks of a Covidien company. ©2015 Covidien. 14-AW-0121
see MOCA page 23
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Continuing Medical Education
CME
WRITTEN BY: Andrey F. Bilko, BS, MD Senior Medical Student Penn State College of Medicine Hershey, Pennsylvania
James J. Lamberg, DO Resident, Department of Anesthesiology Penn State Hershey Medical Center Hershey, Pennsylvania
REVIEWED BY: Sonia J. Vaida, MD Professor of Anesthesiology and Obstetrics and Gynecology Department of Anesthesiology Penn State Hershey Medical Center Hershey, Pennsylvania
LESSON 316
Management of the Patient With Amniotic Fluid Embolism
DISCLOSURES The authors have no relationships with pharmaceutical companies or manufacturers of products to disclose. “Amniotic fluid embolism” by Yale Rosen
PROFESSIONAL GAPS Amniotic fluid embolism is one of the leading causes of maternal mortality (≤10%) in the United States and the Western world. It occurs rarely but is an unpredictable obstetrical emergency. Only with prompt perioperative recognition and management by an anesthesiologist can morbidity and mortality be reduced. Many anesthesiologists may not be aware of the essential steps to be taken for appropriate care.
TARGET AUDIENCE Anesthesiologists
CALL FOR WRITERS If you would like to write a CME lesson for Anesthesiology News, please send and email to Elizabeth A.M. Frost, MD, at elzfrost@aol.com.
LEARNING OBJECTIVES After the completion of this activity, the reader should be able to: 1. Define amniotic fluid embolism 2. State the incidence and prevalence of amniotic fluid embolism 3. Describe the major clinical features of amniotic fluid embolism, including cardiogenic shock 4. List the differential diagnosis for suspected amniotic fluid embolism 5. Describe how to establish a diagnosis of amniotic fluid embolism 6. Describe the cardiovascular, pulmonary, neurologic, and hematologic consequences 7. Determine appropriate initial treatment for life-threatening symptoms 8. Review management options for the first phase of the syndrome 9. Review management options for the second phase of the syndrome 10. Formulate a plan for postoperative management
CASE A 33-year-old, gravida 3, para 2 woman at 36 weeks’ gestation was admitted to the labor and delivery floor for management of painless vaginal bleeding. Her antepartum obstetric history was significant for an anterior placenta previa and a prior cesarean delivery (CD). On admission, the patient was afebrile and normotensive with stable vital signs and her laboratory results were within normal limits. A nonemergent CD was planned. Following the delivery of a viable infant, there was significant difficulty with placental delivery. A classical incision was required for removal of the tissue. During initial closure of the uterine incision, the patient became unresponsive with pulseless electrical activity.
PREANESTHETIC ASSESSMENT Dr. Elizabeth A.M. Frost, who is the editor of this continuing medical education series, is clinical professor of anesthesiology at the Icahn School of Medicine at Mount Sinai in New York City. She is the author of Clinical Anesthesia in Neurosurgeryy (Butterworth-Heinemann, Boston) and numerous articles. Dr. Frost is past president of the Anesthesia History Association and former editor of the journal of the New York State Society of Anesthesiologists, Sphere. She is also editor of the book series based on this CME program, Preanesthetic Assessment, Volumes 1 through 3 (Birkhäuser, Boston) and 4 through 6 (McMahon Publishing, New York City). A Course of Study for AMA/PRA Category 1 Credit Read this article, reflect on the information presented, then go online (www.mssm.procampus.net) and complete the lesson post-test and course evaluation before May 31, 2016. (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: June 1, 2015
Termination Date: May 31, 2016
Accreditation Statement The Icahn School of Medicine at Mount Sinai is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. Credit Designation Statement The Icahn School of Medicine at Mount Sinai designates this enduring material for a maximum of 2.0 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity. It is the policy of the Icahn School of Medicine at Mount Sinai to ensure objectivity, balance, independence, transparency, and scientific rigor in all CME-sponsored educational activities. All faculty participating in the planning or implementation of a sponsored activity are expected to disclose to the audience any relevant financial relationships and to assist in resolving any conflict of interest that may arise from the relationship. Presenters must also make a meaningful disclosure to the audience of their discussions of unlabeled or unapproved drugs or devices. This information will be available as part of the course material. Visit www.mssm.procampus.net today for instant online processing of your CME post-test and evaluation form. There is a registration fee of $15 for this non–industry-supported activity. For assistance with technical problems, including questions about navigating the website, call toll-free customer service at (888) 345-6788 or send an email to Customer.Support@ProCEO.com. For inquiries about course content only, send an email to ram.roth@mssm.edu. Ram Roth, MD, is director of PreAnesthetic Assessment Online and assistant professor of anesthesiology at The Icahn School of Medicine at Mount Sinai, New York, NY.
A
mniotic fluid embolism (AFE) is a rare, apparently unpreventable, and often catastrophic complication unique to pregnancy. It is caused by the introduction of fetal amniotic fluid into maternal circulation. First described in the literature almost 100 years ago, and recognized as a syndrome shortly thereafter, limited progress has been made in understanding the pathogenesis and pathophysiology of AFE due to its rarity and unclear definition. Additionally, most animal studies have shown a wide spectrum of physiologic changes, with the most reasonable conclusion being that the injection of amniotic fluid into the circulation may sometimes result in pathologic effects.1 Current thinking suggests a mechanism of a maternal immune response to fetal material.1-6 In an effort at a more systematic and standardized data collection, Clark et al7 and Tuffnell8 in the United States and the United Kingdom, respectively, established national registries for suspected AFE with entry criteria that included the following: 1. acute hypotension or cardiac arrest; 2. acute hypoxia (dyspnea, cyanosis, or respiratory arrest); 3. coagulopathy or severe hemorrhage; with 4. onset during labor, CD, or within 30 minutes postpartum, with no other explanation for the findings. These criteria have become the basis for recognition of AFE in clinical practice. AFE has a variable presentation, ranging from subtle clinical changes to sudden and fatal cardiopulmonary collapse.1-6 The incidence of AFE varies widely, from 1 in 8,000 to 1 in 80,000 deliveries.9 The latest data suggest an incidence of 1 in 40,000.1 Given that AFE remains a diagnosis of exclusion, with potential underreporting of nonfatal cases and overdiagnosis of fatal cases in obstetrics, the true incidence remains elusive.3 Most cases of AFE occur during labor and delivery or immediately postpartum.1-6 Rare cases occur in the late postpartum period following CD, amniocentesis, placenta removal, or therapeutic dilatation and evacuation, as well as following blunt abdominal trauma, cervical cerclage removal, and ruptured uterus.1-6 Many risk factors have been identified, including maternal age over 35 years, multiple pregnancies, CD, assisted delivery, placenta previa, placental abruption, eclampsia, fetal distress, polyhydramnios, uterine rupture, and ethnic minority status.1-3 Associations have also been made with male sex of the fetus, placement of intrauterine monitoring devices, and artificial rupture of membranes. However, the literature reveals conflicting conclusions, with none of the risk factors proven to have a direct causative link.1 These risk factors are also mostly nonmodifiable and random, making their identification of limited use in reducing or predicting AFE incidence.
Pathogenesis and Pathophysiology The pathogenesis and pathophysiology of AFE are complex and poorly understood, with several proposed hypotheses. It is well accepted that the transfer of amniotic fluid into maternal circulation is the trigger leading to clinical manifestations. Some of the entry routes include endocervical veins, uterine trauma, and placental attachment sites.10 The notion of a pressure gradient favoring transfer into the maternal circulation also has been entertained by some but refuted by others.9
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Continuing Medical Education Once present in the maternal circulation, amniotic fluid precipitates a reaction, the specifics of which remain unclear.1 Classically, it was thought that amniotic fluid emboli physically obstructed maternal pulmonary capillaries causing cardiovascular collapse.1 The lack of physical evidence showing pulmonary vessel obstruction and an inability to reproduce the syndrome in animal models, even with direct intravascular injection of amniotic fluid, suggests a different mechanism.1-6 The clinical events characterized by AFE, such as coagulopathy, acute respiratory distress syndrome (ARDS), and neurologic symptoms, are not typically seen with pulmonary embolism. More recent studies agree on a maternal immune reaction due to a multitude of vasoactive and procoagulant mediators contained within amniotic fluid.1-6 Platelet-activating factor, cytokines, histamine, bradykinin, thromboxane, endothelin, leukotrienes, arachidonic acid, and arachidonic acid metabolites can all be found in amniotic fluid and may cause immunologic and proinflammatory responses leading to symptoms associated with AFE.2,3 Clark compared the manifestations of AFE to systemic inflammatory response syndrome and proposed renaming the syndrome “anaphylactoid syndrome of pregnancy.”1 Two specific hypotheses for the immune reaction responsible for AFE include anaphylaxis and complement activation.11 To support the anaphylaxis mechanism, several studies looked at serum tryptase levels.11 During anaphylaxis, mast cells degranulate in response to immunoglobulin E binding to an antigen, and release inflammatory mediators such as tryptase and histamine, both used as markers for anaphylaxis. Tryptase has a half-life of several hours, making it easier to measure; histamine has a half-life of minutes.11 Results showed either no detectable or slightly elevated tryptase levels in patients with AFE, suggesting that anaphylaxis may not explain the primary mechanism.11 The evidence did support mast cell degranulation taking place only in the lungs of fatal AFE cases, with a possibility of pulmonary mast cell involvement as a secondary process.11 Another theory involves complement activation, which can also result in mast cell degranulation.2,3,11 Several studies showed decreased C3 and C4 levels in women with
Table 1. Differential Diagnosis of Amniotic Fluid Embolism1-5
AFE, suggesting complement activation as a primary immune response followed by mast cell degranulation as a secondary response.11 It is important to note that some extent of complement activation has been shown to be a part of normal labor, with peaks during delivery.11 Complement activation plays an important role in the pathogenesis of ARDS, which is a frequent sequela of AFE, further suggesting the involvement of complement activation.12 Overall, involvement of the complement pathway appears to be a more promising theory, but still only a hypothesis requiring more substantial data. AFE can present with any combination of cardiovascular, pulmonary, neurologic, and hemorrhagic symptoms, with hypotension and nonreassuring fetal status being the most common. These signs and symptoms are followed by pulmonary edema or ARDS, cardiac arrest, and coagulopathy . The hemodynamic changes associated with AFE are complex and not fully understood. Findings from experimental animal studies show AFE is associated with severe pulmonary artery hypertension and right ventricular (RV) failure, caused by either occlusion or vasospasm of the maternal pulmonary vasculature. Acute cor pulmonale and systemic hypotension result.1 Human data do not support sustained periods of pulmonary hypertension, but suggest left ventricular (LV) failure as a precursor to hypotension.1 A biphasic model of cardiogenic shock has been proposed, with acute pulmonary hypertension and RV failure, followed by LV failure to reconcile animal and clinical findings. During cardiogenic shock, systemic vascular resistance (SVR) increases as a compensatory mechanism, although initially SVR may be decreased due to the normal physiologic change in pregnancy and systemic vasodilation during the first stages of AFE.4,12 Transesophageal echocardiography has shown LV failure due
Table 2. Comparison of Signs and Symptoms Of Pulmonary, Venous Air, and Amniotic Fluid Embolisms13 Pulmonary Embolism
Table 3. Laboratory and Diagnostic Tests With Findings Supportive of AFE Diagnosis3,14
Accentuated second heart sound
Laboratory Test
Possible Findings
Apprehension
Arterial blood gases
↓ pH; ↓ PO2; ↑ PCO2
CBC including platelets
↑ WBC; ↓ Hb; ↓ Hct; ↓ platelets (rare)
Hemoptysis Nonproductive cough
Nonobstetric
to impaired LV filling secondary to a dilated right ventricle, with deviation of the interventricular septum into the left atrium and ventricle.2,3 Additional mechanisms for LV failure include myocardial ischemic injury and a direct depressant effect of amniotic fluid on the myocardium. Hypoxia is the most common manifestation of respiratory failure, explained by severe hypoventilation and perfusion mismatch caused by acute pulmonary hypertension and pulmonary edema. Noncardiogenic pulmonary edema occurs in patients in whom LV function improves, suggesting the development of a pulmonary capillary leak syndrome. This theory is supported by the presence of high protein concentrations and amniotic fluid debris in the exudative edema fluid.3,5,10 Although noncardiogenic pulmonary edema seems to result from widespread damage to the alveolar-capillary membrane, similar to the mechanism of ARDS, lung function recovers much quicker than the typically prolonged course of ARDS. The mechanism behind coagulopathy in AFE is unclear and likely multifactorial. It is thought to result from both procoagulant and anticoagulant factors present in amniotic fluid. The current hypothesis suggests that tissue factor contained in amniotic fluid activates the extrinsic coagulation pathway by binding with factor VII, which in turn activates factor X, leading to a consumptive coagulopathy.3,5 Once the clotting cascade is activated in the pulmonary vasculature, local thrombin generation leads to vasoconstriction and microvascular thrombosis. Amniotic fluid also contains activated clotting factors II, VII, and X, but the concentrations are much lower than that found in maternal serum at term.5 Several studies used thromboelastography and showed that addition of amniotic fluid to blood from pregnant women accelerated clot formation with no evidence of fibrinolysis, further suggesting consumptive coagulopathy as the primary cause for hemorrhage.3,5,6
Pleuritic chest pain
Pulmonary embolism
Myocardial infarction
Sudden onset of tachypnea
Venous air embolism
Cardiomyopathy
Coagulation profile
↑ prothrombin; ↑ thromboplastin; ↓ fibrinogen
Venous Air Embolism
Septic shock
Aspiration
Diagnostic Test
Possible Findings
Chest pain
Chest radiograph
Bilateral interstitial and alveolar infiltrates
Anaphylactic shock
Electrocardiogram changes
Obstetric
Gasping
Placental abruption
Uterine atony
Mill-wheel murmur
Eclampsia
Acute hemorrhage
Reduced ETCO2 (without arrest)
Uterine rupture
Peripartum cardiomyopathy
Amniotic Fluid Embolism
Uterine laceration
Consumptive coagulopathy
Anesthetic
Profuse hemorrhage
High neuraxial blockade Medication error
Seizures
Local anesthetic toxicity
Transfusion reaction
ETCO2, end-tidal carbon dioxide
Electrocardiogram Tachycardia, ST and T-wave abnormalities, arrhythmias Echocardiography Acute right ventricular failure with leftward deviation of intra-atrial and intraventricular septum, acute left heart failure with diminished left ventricular contractility, severe pulmonary hypertension CBC, complete blood count; Hb, hemoglobin; Hct, hematocrit; PCO2, carbon dioxide partial pressure; PO2, oxygen partial pressure; WBC, white blood cell
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Continuing Medical Education Differential Diagnosis The clinical presentation of AFE is variable, with all of the characteristic symptoms not evident on the initial patient presentation, making the differential diagnosis broad (Table 1). It is useful to recognize the sometimes subtle differences in the presentation of pulmonary, venous air, and amniotic fluid embolism. Several signs are shared between these three disorders, including hypotension, dyspnea, cyanosis, and cardiovascular collapse. Table 2 lists other signs for each of the disorders that are not typically shared.
Diagnosis AFE is a clinical diagnosis of a woman in labor or immediately postpartum who acutely experiences a cardiopulmonary collapse with concomitant neurologic and/or hematologic symptoms. Sudden onset of hypoxia, hypotension, and coagulopathy has been described as a classic triad of AFE, recognizing that many cases do not exhibit all of these symptoms.7 More subtle cases depend on exclusion of other alternative diagnoses. Signs of fetal distress can be presenting or accompanying signs of AFE due to hypoxia and fetal hypoperfusion.1 Many laboratory findings have been proposed as diagnostic of AFE, including levels of tryptase, arachidonic acid metabolites, and other inflammatory or immunologic markers.1,11 Measurement of serum sialyl Tn antigen levels and concentrations of zinc coproporphyrin are other experimental tests.1-6 Specific postmortem findings such as immunohistologic staining for evidence of pulmonary mast cell degranulation are inconclusive, whereas the presence of fetal material in the pulmonary circulation is accepted by some as indicative of AFE, although it has been shown to be also present in healthy women.1,11 Several laboratory and diagnostic tests may support the diagnosis of AFE but are nonspecific (Table 3). The diagnosis of AFE does not have to be immediate because the treatment is supportive based on observed symptoms.
Table 4. Management of Amniotic Fluid Embolism1,12,14
However, it is extremely important to react promptly to any such symptoms, and be prepared for rapid deterioration.
Treatment The overall management of AFE is symptomatic and based on maintaining oxygenation, cardiac output, blood pressure, and correcting coagulopathy (Table 4). The treatment of these life-threatening symptoms can be divided into 2 phases. The first phase focuses on cardiopulmonary collapse and the second addresses coagulopathy and hemorrhage. Rapid maternal cardiopulmonary stabilization is the key to preventing mortality and morbidity. If the fetus has not been delivered at the time of cardiac arrest and is of viable gestational age, an immediate CD should be considered.15 If fetal viability is unknown or questionable, the decision to perform emergency CD depends on whether or not the gravid uterus is thought to interfere with maternal hemodynamics. Fundal measurements are inconsistent in estimating gestational age and should not be used for evaluation of fetal viability.15 Delivery of the fetus reduces the weight of the uterus onto the inferior vena cava, increases blood return to the heart thus increasing systemic blood pressure, and reduces fetal exposure to hypoxia in utero. Left uterine displacement may improve venous return and cardiac output at 30 rather than 15 degrees.16 Although it may make chest compressions more difficult, left uterine displacement should be attempted. With the onset of hypoxia, delivery of 100% oxygen should not be delayed in order to prevent irreversible neurologic injury and should be initiated by any available means including face mask, bag-valve mask, or preferably endotracheal intubation with mechanical ventilation. Oxygen saturation should be maintained at 90% or higher.3 The advanced cardiovascular life support (ACLS) algorithm should be followed with certain modifications for pregnant patients in the case of asystole or pulseless electrical activity (Table 5). Hypotension management is aimed to optimize preload by rapid volume infusion using isotonic crystalloid solutions.
Goal
Treatment
Maintenance of oxygenation
Supplemental 100% oxygen Intubation and mechanical ventilation
Cardiovascular support
Chest compression and fetal delivery Lateral (left) displacement of uterus Volume resuscitation with crystalloids Vasopressors (direct acting and other inotropes) Invasive blood pressure monitoring
Activation of maternal code blue, resulting in a multidisciplinary team approach
Massive transfusion protocol activation Blood component therapy, including cryoprecipitate Repeated laboratory assessment of patient’s blood Normothermia maintenance
Anticipation of a difficult airway
Coagulopathy and hemostatic support
Fetal well-being Emergency cesarean delivery (if mature and undelivered)
Table 5. Specific Considerations for Cardiopulmonary Resuscitation During Pregnancy12,15,17,18
Left uterine displacement Chest compression modification with more cephalad hand placement Removal of both internal and external fetal monitors (if present) Stopping magnesium (if receiving prearrest) and giving calcium chloride 10 mL in 10% solution, or calcium gluconate 30 mL in 10% solution Perimortem cesarean delivery at 4 min after cardiac arrest onset Complete delivery of fetus within 5 min after cardiac arrest onset Evaluation for need of cardiopulmonary bypass
Table 6. Experimental Treatment Modalities For Amniotic Fluid Embolism3,6,14,19 Cardiopulmonary bypass Extracorporeal membrane oxygenation Intra-aortic balloon counterpulsation Inhaled nitric oxide Inhaled aerosolized prostacyclin High-dose corticosteroids Serine protease inhibitor Continuous hemofiltration (hemodiafiltration) Plasma exchange transfusion Uterine artery embolization
In cases of refractory hypotension with suspicion of low SVR, direct-acting vasopressors such as phenylephrine or norepinephrine should be used temporarily to restore aortic perfusion pressure.3-5 Inotropes such as dopamine, dobutamine, and/or milrinone may be used to improve myocardial contractility secondary to ventricular dysfunction due to their additional β-adrenergic agonist activity.3,4,19 Vasopressin spares the pulmonary vasculature from vasoconstriction, especially at low doses, and can be used as a primary or adjunct agent.4 Systolic blood pressure should be maintained at ≥90 mm Hg, with an arterial PaO2 of ≥60 mm Hg, and urine output of ≥0.5 mL/kg/h.3,9 The use of diuretics may be necessary to mobilize pulmonary edema fluid.6,19 Treatment of coagulopathy and hemorrhage associated with AFE requires blood component therapy, most often with activation of a massive transfusion protocol.12 Massive hemorrhage requires replacement with packed red blood cells and platelets, if thrombocytopenia is present.14,18 Specific coagulation laboratory abnormalities should guide administration of fresh frozen plasma, cryoprecipitate, and/or factor replacement.3,5,14 Cryoprecipitate is especially useful when fibrinogen is low or when volume overload is a concern.3,19 Cryoprecipitate also contains fibronectin, an opsonic α2 surface-binding glycoprotein that facilitates filtering of cellular and toxic particulate matter, such as amniotic fluid debris, through the reticuloendothelial system.3,6,18 The use of recombinant activated factor VIIa may be considered as a last resort in patients refractory to massive blood component therapy. However, it should be avoided for routine use because it can combine with circulating tissue factor, thus enhancing intravascular clot and worsening outcomes.1,2,4,19 Disseminated intravascular coagulation is often associated with uterine atony, which may require treatment with uterotonic medications, such as oxytocin, and even necessitating a hysterectomy if hemorrhage cannot be controlled with aggressive blood product transfusion.3,14 There are a number of newer treatment strategies that remain anecdotal and experimental (Table 6).
Anesthetic Management Standard monitoring, as defined by the American Society of Anesthesiologists (ASA), applies throughout the perioperative period. Monitoring of the patient should include continuous
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Continuing Medical Education cardiac telemetry and respiratory monitoring with a pulse oximeter and capnography.3,14 Establishing IV access is vital during resuscitation. Largebore peripheral IV catheters, 18-gauge or larger, are preferred due to a high flow rate and their ease of placement. Placement of catheters above the diaphragm may be advantageous as aortocaval compression can prevent venous return to the heart. Most peripheral IV catheters have greater flow rates when compared with central venous catheters. A central venous catheter may be used for vasopressor infusion, but placement should not delay resuscitation efforts.4,14 Intraosseous cannulation is an option if IV access cannot be obtained. Intra-arterial catheterization is especially useful for continuous and accurate arterial blood pressure monitoring and direct access to blood samples for arterial gas evaluation.3,4,14 With the progression of AFE, right-sided ventricular failure leads to left-sided failure, making a pulmonary artery catheter a consideration during fluid management.9 Transesophageal or transthoracic echocardiography is useful in guiding volume therapy and assessing cardiac function by evaluating LV filling.3,5,12,14 Current literature has not reviewed the use of stroke volume variation, pulse pressure variation, or esophageal Doppler in patients with AFE. These newer therapies have many theoretical advantages over pulmonary artery catheterization, but more studies are needed in this patient population. Most patients with AFE require transfer to the ICU. Mechanical ventilation, vasopressor support, and inotropic support are often continued. Maternal mortality varies greatly, between 20% and 90%, with worst outcomes following cardiac arrests despite appropriate treatment.1 Recently, mortality seems to be declining, which is mostly attributed to early diagnosis and better intensive care. Morbidity, however, remains high, with frequent devastating sequelae such as neurologic impairment.14
Management of the Case Presented Following endotracheal intubation and 2 rounds of ACLS resuscitation, spontaneous circulation returned. With 2 large-bore IV lines available, an epinephrine infusion at 0.3 mcg/kg/min was started. Central venous and intra-arterial catheters were placed. Significant bleeding suggested coagulopathy following closure of the abdominal fascia. A massive transfusion protocol was initiated. Hemostasis and surgical site closure were achieved after transfusion of 10 units of packed red blood cells, 7 units of fresh frozen plasma, and 1 dose pack of platelets. The initial arterial blood gas results showed metabolic and respiratory acidosis with pH 7.11, PCO2 53 mm Hg, and base deficit 11. The coagulation panel revealed elevated prothrombin and thromboplastin with low fibrinogen. Once transferred to the ICU, the patient continued to display worsening oxygenation despite increased positive end expiratory pressure. Cardiac arrest requiring ACLS resuscitation and cardioversion again occurred. With diffuse intrauterine hemorrhage she was taken back to the operating room for an emergent hysterectomy during which a third cardiac arrest took place. Resuscitation was successful following ACLS protocol and massive transfusion of 29 units of packed red blood cells, 32 units of fresh frozen plasma, 9 units of cryoprecipitate, and 8 dose packs of platelets. Angiographic uterine artery embolization was considered but the patient was not
hemodynamically stable to allow safe transport to the interventional radiology suite. Following hysterectomy, the patient was transferred back to the ICU intubated, on vasopressor and ionotropic support with epinephrine, norepinephrine, milrinone, and furosemide. She improved, was extubated on the third postoperative day and discharged on postoperative day 10 without any neurologic deficits.
4.
Gist RS, et al. Anesth Analg. 2009;108:1599-1602.
5.
Oâ&#x20AC;&#x2122;Shea A, et al. Int Anesthesiol Clin. 2007;45:17-28.
6.
Davies S. Can J Anaesth. 2001;48:88-98.
7.
Clark SL, et al. Am J Obstet Gynecol. 1995;172:1158-1167.
8.
Tuffnell DJ. BJOG. 2005;112:1625-1629.
9.
Aurangzeb I, et al. Crit Care Clin. 2004;40:643-650.
Conclusion
11.
Benson MD. Clin Dev Immunol. 2012;2012:946576.
Despite the rarity of the syndrome, recognition and management of AFE are essential and require vigilance and immediate action. Prompt response to maternal cardiopulmonary collapse and anticipation of consumptive coagulopathy reduces the chances of maternal and fetal mortality and morbidity. The current understanding of AFE is still limited requiring a need for further research with a higher level of evidence.
12.
Chestnut, DH. Chestnutâ&#x20AC;&#x2122;s Obstetric Anesthesia: Principles and Practice. 5th ed. Philadelphia, PA: Elsevier Saunders; 2014:915-920.
13.
Atlee JL. Complications in Anesthesia. 2nd ed. Philadelphia, PA: Elsevier Saunders; 2007:786-788.
Abbreviated References
17.
1.
Clark SL. Obstet Gynecol. 2014;123:337-348.
18. Einav S, et al. Resuscitation. 2012;83(10):1191-1200.
2.
McDonnell NJ, et al. Int J Obstet Anesth. 2013;22:329-336.
3.
Conde-Agudelo A, et al. Am J Obstet Gynecol. 2009;201:445.e1-e13.
19. Fleisher LA. Anesthesia and uncommon diseases. 6th ed. Philadelphia, PA: Elsevier Saunders; 2012:547-550.
10. Baldisseri MR. UpToDate.com. Accessed January 6, 2015.
14. Moore J, et al. Crit Care Med. 2005;33:S279-S285. 15. Vanden Hoek TL, et al. Circulation. 2010;122 (suppl 3):S829-S861. 16. Higuchi H, et al. Anesthesiology. 2015:122(2): 286-293. Lipman S, et al. Anesth Analg. 2014;118(5):1003-1016.
Post-Test 1. The shock state seen with amniotic fluid embolism (AFE) most resembles which of the following? a. Cardiogenic shock b. Distributive shock c. Hypovolemic shock d. Obstructive shock 2. The least appropriate product in the management of coagulopathy secondary to AFE is _____. a. cryoprecipitate b. fresh frozen plasma c. recombinant factor VIIa d. tranexamic acid 3. Of the following, the most likely risk factor for AFE is _____. a. fetal growth restriction b. nulliparity c. oligohydramnios d. placenta previa 4. Which of the following signs or symptoms is commonly seen with AFE but not typically seen with either venous air embolism or pulmonary embolism? a. Consumptive coagulopathy b. Cyanosis c. Dyspnea d. Systemic hypotension 5. Which of the following best describes the current understanding of the pathophysiology of AFE? a. Embolism of fetal material within the maternal pulmonary circulation b. Extensive mast cell degranulation with massive histamine release c. Maternal immune response to fetal material in the circulation d. Widespread activation of the clotting cascade with fibrinolysis
6. The classical triad of AFE is most likely to include_____. a. coagulopathy, hypotension, hypoxia b. cyanosis, coagulopathy, hemoptysis c. gasping, mill-wheel murmur, hypotension d. hypotension, dyspnea, cyanosis 7. Which of the following is most appropriate for the management of maternal cardiac arrest during pregnancy? a. Avoidance of epinephrine due to high risk for fetal acidosis from uteroplacental insufficiency b. Maintenance of supine position to direct cardiac output toward the brain c. Measurement of fundal size to determine fetal viability and need for emergent cesarean delivery d. Removal of internal and external fetal monitors 8. AFE occurs _____. a. intrapartum b. prepartum c. postpartum d. potentially during any of the above periods 9. Which of the following would be the most appropriate for management during the first phase of AFE? a. Cryoprecipitate b. Norepinephrine c. Supine positioning d. Uterine artery embolization 10. Intraoperative transesophageal echocardiography for a patient with AFE would most likely show which of the following? a. Diminished left ventricular contractility with significant pulmonary hypertension b. Hyperdynamic function, low afterload, and inadequate preload c. Obliteration of left ventricle at end systole and collapse of the vena cava with respirations d. Right ventricular collapse with marked respiratory variation of pulse pressure
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CLINICAL ANESTHESIOLOGY
Communicating and Managing the Difficult Airway Joseph Loskove, MD
P
atients designated as “difficult to intubate” (DTI) are more at risk for losing their lives during both emergency and routine surgeries. Surprisingly, it is not the difficult airway itself that is most life-threatening; modern medical technology allows physicians to intubate even the most difficult of cases. Deadly mistakes often occur in the process of identifying, communicating and managing the existence of the difficult airway, especially among numerous providers.
Challenges to Proper DTI Management The first and greatest challenge that health care providers face when dealing with a difficult airway is effective communication. In today’s landscape, a provider is likely to be part of a much larger health care system made up of multiple facilities that provide care to tens of thousands of patients every year. Traditionally, notification of a patient’s difficult airway includes informing only the anesthesia team; there is a lack of an organized method to communicate the information to other providers. In this traditional model, a patient’s DTI status is not likely to be communicated in scenarios where the patient is moved to a different department, perhaps being treated by a different anesthesia team—not uncommon in the operating rooms (ORs) and emergency rooms (ERs) of large hospital systems. The second challenge facing providers is that the primary responsibility to intubate a patient outside of the OR rests with non-anesthesiaa providers, such as emergency department physicians, intensivists and trauma surgeons. This poses a challenge because these providers may not know the patient has a difficult airway, may not be experienced with difficult intubations and may not have the proper DTI equipment on hand. The availability of advanced airway equipment (e.g., video laryngoscopes, bronchoscopes, surgical airway equipment and laryngeal mask airways) is a third challenge, because such equipment is not always atthe-readyy in ICUs and ERs. The fourth challenge is that most health care systems use a combination of electronic and paper documentation. Thorough and consistent documentation is critical for DTI patients, especially for any future admissions to any facility in the system. Fortunately, there are effective solutions that address each one of these challenges.
DTI patient” as a patient for whom a conventionally trained laryngoscopist experiences difficulty with mask ventilation, difficulty with tracheal intubation, or both. Using this definition, any physician from the departments of anesthesia, emergency medicine, otolaryngology, intensive care and trauma may deem a patient a DTI and can indicate it on the patient’s chart. Once the patient is identified as DTI using a consistent definition, the next step is communicating his or her DTI status to any provider that will be in contact with that patient. Traditionally, the DTI status is communicated by placing a sign over the bed or on the whiteboard in each room. However, because patients may travel throughout a facility for tests and procedures, that method is not sufficient. One solution with which Memorial Healthcare has found success is to place a bracelet on the wrist of the patient with “DIFFICULT TO INTUBATE,” which will stay on the patient for the duration of hospitalization. In addition, a notation—“DIFFICULT TO INTUBATE”—is placed in the allergy section of the electronic health record, ensuring this information is available for subsequent visits to any facility within the system. Thus, a DTI designation is treated like an allergy—just as a patient is banded with an allergy bracelet on admission to the emergency department or hospital, so too, a DTI patient is banded on entrance into the health care system. To better communicate with patients and their families or caregivers, Memorial Healthcare sends a letter Proven Solutions From to provide education on their DTI designation. This Memorial Healthcare System should coincide with educational efforts throughA comprehensive difficult airway management pro- out the hospital system to train or retrain all staff and gram, like the one instituted at Memorial Healthcare physicians on the DTI protocol so that any provider System in Hollywood, Fla., streamlines the identi- can answer patients’ questions. fication, communication and management of difOnce a system is in place to correctly identify a ficult airways and thereby reduces life-threatening patient as DTI and band him or her to ensure the designation is communicated, steps must be taken to complications. The first step is to define what a DTI patient is obtain the necessary equipment. This can be done by in terms that a physician from any department can introducing standardized DTI carts throughout all understand and use. Memorial Healthcare defined “a facilities in the system, including the ORs, ERs and
ICUs.. The new w standardized DTI carts are similar to a “code” cart—the carts at all facilities are stocked identically, and when opened are returned to a centralized location to be cleaned or sterilized, restocked and resealed. Process and Outcome Improvements The new DTI protocol described in this article was introduced at Memorial Healthcare in February 2012. Shortly after, a patient was admitted to the ER of one of the Memorial Healthcare hospitals with an acute myocardial infarction and required intubation. The ER physician encountered difficulty and the anesthesia team was asked to assist. Subsequent intubation was successful and the ER physician then wrote an order in the chart deeming the patient to be DTI. When the patient was transferred to another Memorial Healthcare hospital for urgent cardiac catheterization, a nurse noted the DTI designation in the allergy section of the patient’s electronic record and placed the DTI wristband on the patient. Although this step should have been completed in the first institution where the patient was initially designated as DTI, the extensive educational efforts that took place raised the level of awareness of nursing staff across the hospital and helped the nurse in the second facility recognize the DTI risk. After undergoing a successful cardiac catheterization and stabilization, the patient was transferred to a third Memorial Healthcare hospital for coronary artery bypass graft surgery. In the preoperative holding area, the anesthesiologist noted the DTI wristband and brought the new DTI cart into the OR. Upon induction of anesthesia, the patient’s airway was found to be challenging, but the anesthesiologist was able to use the equipment available on the DTI cart to successfully and atraumatically intubate the patient. The patient underwent surgery and was discharged home in good condition. Implementing this protocol can address the many challenges that a difficult airway presents to hospitals and healthcare systems. As large networks of hospitals become more common, it will be crucial for physicians, nurses and technicians to be educated in effective DTI communication methods such as the one instituted at Memorial Healthcare System. Joseph Loskove, MD, is the chief of anesthesia for Memorial Healthcare System and is a regional medical director of the anesthesia division of Sheridan Healthcare, a provider of outsourced physician services. Dr. Loskove has no relevant financial disclosures.
JUNE 2015
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PRN MOCA
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PPAI modules. Furthermore, we also seek removal of the secure examinations from all MOCA-SUBS recertifications since by subspecializing, they are, if anything, already at a greater depth of knowledge regarding their core patients. Also, we believe that the cost of $2,100 per decade remains overpriced. The National Board of Physicians and Surgeons (NBPAS) leadership has pledged to keep their costs of certification (60% cheaper than the ABA) directly related to the costs of administering it. It is unlikely that the MOCA Minute will cost the ABA $210 per diplomate per year to administer. It amounts to a “practice tax” imposed by the ABA on those not grandfathered, and would be better spent elsewhere. The program should cost us what it costs the ABA to administer. Finally, we believe that the entire MOCA process should be voluntary—this is a change that the ABMS should make with all its member boards. Why should those who certified before a certain date be treated any differently than more recently certified diplomates? We think MOCA should be an optional program. Now that the program is much less intrusive, many if not most would probably choose to participate. Nevertheless, this should be a freely made choice rather than a compulsory requirement, as noncompliance yields revocation of certification and the probable loss of hospital privileges. We believe that this optional participation in MOCA should serve only as “proof ” that the diplomate has been exposed to relevant recent literature, but that this should not affect the actual certification status. As such, it would ideally be renamed “Maintenance of Currency in Anesthesiology.” So, although there is much cause for celebration with this announcement, we ask the ABA to take these steps to complete reforming MOCA into an acceptable program. Meanwhile, we will stand ready alongside the nearly 1,400 signatories (at press time) at http://www. petitionbuzz.com/petitions/change moca to voice any future concerns we have if the ABA again moves to make MOCA a more costly, burdensome program.
HANG UP
about the necessity of knowing their medical history and medications. PhyTrauma and emergency med- sicians should support the concept icine providers should be at the of keeping a hard copy of this data forefront of educating parent and at hand in case of technology failure. school groups about the dan- Patients should be encouraged and gers of texting and driving and have the ability to go into their record the many other aspects of elec- and review and correct any errors on a tronic addiction. Hospitals should regular basis. clearly post signs noting that I believe technology has been a patients must put their devices great boon to our society, but in many away during exams. Physicians respects it has been introduced so rapshould also educate their patients idly that we have not been able to CONTINUED FROM PAGE 13
adapt to it and control its many pitfalls. The human brain needs to be trained to become adept with this technology and integrate it to provide humanistic effective care. We must truly understand how to rewire our brains to cope with this technological, hypersocial world. Dr. Papadakos, a member of the Anesthesiology News advisory board, is director of Critical Care Medicine at the University of Rochester Medical Center, in Rochester, N.Y. He writes and lectures on the impact of technology on medical care.
The authors reiterate that they have no conflicts of interest other than being diplomates of both the NBPAS and the ABA.
EXP-AP-0020-201301
Used in more than 1 MILLION PATIENTS since 2012
EXPAREL is a real leap forward in how we treat patients and deal with postsurgical pain. — Richard A. Baxter, MD Plastic Surgeon; Seattle, Washington
Experience the impact: Reduce the need for opioids while providing long-lasting postsurgical pain control—all from a single dose. EXPAREL is indicated for single dose ad administration dministration into the surgical site to produce postsurgical po analgesia. Important Safety Information EXPAREL is contraindicated in obstetrical paracervical block anesthesia. EXPAREL has not been studied for use in patients p younger y g than 18 years y of age. g Non-bupivacaine-based p local anesthetics,, includingg lidocaine,, mayy cause an immediate release of bupivacaine from EXPAREL if administered together locally. The administration of EXPAREL may follow the administration of lidocaine after a delay of 20 minutes or more. Other formulations of bupivacaine should not be administered within 96 hours following administration of EXPAREL. Monitoring of cardiovascular and neurological status, as well as vital signs should be performed during and after injection of EXPAREL as with other local anesthetic products. Because amide-type local anesthetics, such as bupivacaine, are metabolized by the liver, EXPAREL should be used cautiously in patients with hepatic disease. Patients with severe hepatic disease, because of their inability to metabolize local anesthetics normally, are at a greater risk of developing toxic plasma concentrations. In clinical trials, the most common adverse reactions (incidence ≥10%) following EXPAREL administration were nausea, constipation, and vomiting. Please see brief summary of Prescribing Information on reverse side. For more information, please visit www.EXPAREL.com or call 1-855-RX-EXPAREL (793-9727). Data on file. Parsippany, NJ: Pacira Pharmaceuticals, Inc.; February 2015.
©2015 Pacira Pharmaceuticals, Inc., Parsippany, NJ 07054 PP-EX-US-0664 04/15
PRINTER-FRIENDLY VERSION AVAILABLE AT ANESTHESIOLOGYNEWS.COM
Current and Emerging Technology In Anesthesia
ALLAN F. SIMPAO, MD 2015 Annual Meeting Program Chair, Society for Technology in Anesthesia Assistant Professor of Anesthesiology and Critical Care Perelman School of Medicine at the University of Pennsylvania and The Children’s Hospital of Philadelphia Philadelphia, Pennsylvania
JORGE A. GALVEZ, MD Assistant Professor of Anesthesiology and Critical Care Hospital of the University of Pennsylvania Perelman School of Medicine at the University of Pennsylvania and The Children’s Hospital of Philadelphia Philadelphia, Pennsylvania The authors report no relevant financial conflicts of interest.
T
echnology has been integrated into almost every facet of anesthesia practice, from
patient monitors and anesthesia machines to documentation and drug delivery. In the course of a typical day, anesthesia practitioners care for patients using an array of technologies whose sophistication and utility are continually increasing.
Meanwhile, researchers and innovators are constantly working on leveraging new technologies (and new uses for old technology) for myriad benefits: improved patient care, enhanced financial oversight and responsibility, outcomes research, and many others. This review will focus on recent technological developments in anesthesia and prognosticate on developments that will likely be coming in the near future. Software-related solutions will be discussed first, followed by descriptions of novel devices and hardware.
Anesthesia Information Management and Clinical Decision Support Systems Anesthesia information management systems (AIMS) began as simple automated intraoperative record keepers, the core function of which remains the generation of an automated, continuous electronic anesthesia record
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that captures and documents the patient’s physiologic data (eg, vital signs) and allows for the manual notation of intraoperative events (eg, drug administration).1 Since then, AIMS have evolved into sophisticated hardware and software systems that are currently available as either stand-alone products or part of a hospital’s electronic health record (EHR) system; both types offer features to expand their capabilities beyond intraoperative record keeping to enhance other aspects of the perioperative experience. For example, most AIMS allow their users to view patients’ previous anesthetic records and preoperative assessment forms. AIMS that are part of a hospital’s EHR can retrieve relevant patient information (eg, age, weight, allergies, medication lists) from the EHR and then load that information automatically into the preoperative assessment and intraoperative record.2 AIMS have been shown to improve the quality and safety of patient care, and clinical decision support systems (CDSS) are one of the factors that have contributed to these benefits.3,4 CDSS have become increasingly integrated into AIMS, and can be grouped into 3 categories: process of care (eg, improving adherence to clinical protocols and guidelines, such as perioperative antibiotic administration5), practice management (eg, billing, maximizing operating room efficiency and throughput6), and outcome-based decision support (eg, facilitating care that leads to better patient outcomes7). CDSS are currently an active area of anesthesia research and development, largely due to their potential to improve patient care and outcomes. Nair et al demonstrated numerous benefits with the use of their Smart Anesthesia Manager (SAM),8 a near–real time AIMSbased CDSS module, including beta-blocker medication administration,9 reduced wastage of inhalation anesthetics,10 and improved management of intraoperative
Figure 1. Smart Anesthesia Manager (SAM). The SAM is a clinical decision support system module that works with anesthesia information management systems.
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hypertension and hypotension11 (Figure 1). Anesthesiologists at Colorado Children’s Hospital use iCare (iCare Finland), an emergency AIMS-based CDSS module that provides real-time guidance and calculates drug doses automatically during common anesthesia emergencies.12 AlertWatch (AlertWatch Inc.), another recently developed CDSS, is a secondary monitoring system with FDA 510(k) clearance that integrates aggregated data from physiologic monitors, the AIMS, and the EHR (eg, patient history and physical and lab values), and presents quality and safety alerts to clinicians13 (Figures 2 and 3). Although AIMS with CDSS have been shown to provide numerous benefits, much room remains for future advancement of the technology. As AIMS evolve, their user interfaces can be optimized to facilitate perioperative workflow. In the case of stand-alone AIMS, interoperability with hospital EHR and other AIMS systems should be the goal. The ongoing integration and validation of CDSS within AIMS offers many avenues for enhancing patient safety and outcomes.
Registries and ‘Big Data’ The proliferation of AIMS across anesthesia departments and practices has enabled the establishment and growth of large national data sets (“Big Data”14) describing anesthesia patients, procedures, and outcomes.15 Even though reporting outcomes data is a sensitive topic, participation in a national registry allows anesthesia practices to benchmark their performance against other providers and practices, and enables researchers to explore data from rare anesthesia-related events.16 The Anesthesia Quality Institute’s National Anesthesia Clinical Outcomes Registry and the Multicenter Perioperative Outcomes Group are two examples of large, anesthesiology-specific databases that have been used recently for quality improvement and data-driven outcomes studies.17,18 Over time, national anesthesia registries will continue to recruit contributors and increase in size, thereby offering a greater pool of data for research and data mining. In the United States, federal initiatives such as the Meaningful Use program will continue to foster aggregation of data at a national level through health information exchanges and national repositories designed to track population health. There will continue to be ongoing development of passive transfer of outcomes data from the AIMS and EHR rather than the manual, self-reported method that requires the active participation of the clinician.16 Efforts by the federal government should also increase the interoperability and data-sharing capabilities across various EHRs, further fueling the contribution of data to these anesthesia “Big Data” initiatives. As reporting and data pooling improve, so should the ability for queries of the registries’ entries and logs to obtain earlier identification of adverse drug or equipment event patterns, as others have reported with Web search data.19
Figure 2. AlertWatch: OR Patient View. The screenshot shows the patient view within AlertWatch:OR. This view shows a summary view of the case, with organ-based icons, colors and alerts for potential issues.
Figure 3. AlertWatch: Census View. The screenshot shows the census view within AlertWatch:OR. Each rectangle shows the status of a specific case. The icons indicate specific alerts and patient risk factors. The bar chart shows the progress of the case, and the remaining text summarizes provider and operating room information.
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Barcode Labeling and Readers Software-based technological solutions such as AIMS and CDSS provide one layer of protection against patient harm, while anesthesia Big Data registries can be used to report and warn others of adverse events. Anesthesia researchers and innovators are also constantly endeavoring to design and create physical devices and systems that can reduce the likelihood of patient harm and supply another layer of protection against patient harm. For instance, medication error in the operating room is a leading cause of adverse events in patients undergoing anesthesia due to misidentification of medication vials and syringes.20 There are various modalities that
have been implemented to prevent this error, including a barcode reader linked to a computer, customized drug trays, prefilled syringes, color-coded drug labels, and integrated AIMS warnings.21 Of these modalities, the barcode reader has been the focus of multiple recent research efforts as well as commercially developed medical devices that are subject to FDA approval. The Codonics Safe Label System is an FDA-approved medication syringe barcode labeling and reader system, which one group found improved compliance with labeling requirements from 63.8% to 98.6% using conventional labeling22 (Figure 4). Jelacic et al experienced greater than 75% compliance with their medication syringe labels after combining the Codonics system with their SAM software.23 The BD Intelliport Medication Management System is a new FDA-approved medical device that not only incorporates automated barcode scanning and labeling of medication syringes, but also automatically identifies, measures, and documents IV bolus injections in the AIMS and EHR24 (Figure 5). Barcode technology has also been applied as a safety check for blood transfusions. A study reported 100% accuracy in matching patients with their blood component transfusions using barcode scanners,25 while another study found that barcoding significantly increased the identification of near-miss events.26
Smart Pumps and Computer-Controlled Drug Infusion Delivery Optimizing medication dosage and delivery can also lead to improved patient safety. IV infusion is one of the common routes by which medications are delivered to patients in the operating room, and safe
Figure 4. The Codonics Safe Label System. The Safe Label System is a medication syringe barcode labeling and reading system that addresses common drug errors made in the operating room. The system prints full-color labels that comply with The Joint Commissionâ&#x20AC;&#x2122;s requirements.
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Figure 5. The BD Intelliport Medication Management System. This system incorporates barcode scanning and labeling of syringes and automatically documents IV bolus injections in an anesthesia information management system and electronic health record.
and effective clinical use of these infusions depends on understanding critical parameters, such as fluid flows and dead volume that influence performance and safety.27 Smart infusion pumps incorporate drug libraries and dose error reduction systems that intercept errors, such as the wrong rate, wrong dose, and pump setting errors, and have been shown to reduce (albeit not eliminate) programming errors.28 Although smart pumps are helpful in decreasing the risk for drug errors, substantial delays in achieving steady state may still occur when anesthesia providers set very low flow infusion rates; such delays can be potentially hazardous, especially for pediatric patients.29 Parker et al recently reported novel algorithm-based computer control to reduce the temporal lags in carrier and drug flows, thereby improving the match between the user’s intent and the reality of pump-driven infusion of medications.30
Integrated Information Displays Novel approaches in patient monitors and monitoring systems are also aimed at reducing errors and enhancing patient safety. Traditional device displays include those on the patient monitor, infusion pumps, EHR, and ventilator control panel. This array of information sources can affect nurses’ situational awareness of the patient in the ICU.31 In response, integrated information displays have been developed to display in close proximity the information that is used for comparable tasks; this has been shown to increase nurses’ situational awareness and decrease the time needed to complete tasks.32 The potential for integrated informational displays to decrease errors and improve reaction time to a patient’s clinical needs has been shown mainly in the ICU,33 but such displays could be employed throughout the perioperative period to enhance anesthesia providers’ situational awareness.
Noninvasive Patient Monitoring Systems Numerous recent advances in noninvasive monitoring of patients’ vital signs and lab values have been reported in the literature. One new device uses a cloth sensor that is applied to a patient’s neck and employs acoustic signal processing to monitor the patient’s respiratory rate.34 The novel acoustic sensor method has been shown to be more precise than thoracic impedance and better tolerated than capnometry with a face mask in obese patients recovering from anesthesia.35 The acoustic sensor technology has also demonstrated rapid detection of changes in respiratory rate under conditions of general anesthesia with a laryngeal mask airway.36 Thus, noninvasive acoustic monitoring is a promising adjunctive modality for measuring and verifying respiratory rates in patients. Noninvasive monitoring technology has also been developed to trend blood hemoglobin levels continuously via CO oximetry (SpHb, Masimo). A recent study in volunteers demonstrated high precision of
SpHb during hemodilution and fluid bolus, yet suboptimal accuracy found during comparisons between SpHb and arterial blood sampling suggested that the device is likely not sufficient to be the sole factor for making transfusion decisions.37 The portable, noninvasive, instant SpHb was also studied as a preoperative assessment tool for low hemoglobin levels, and was found to have high sensitivity for detecting anemia in males (93%) and lower sensitivity in females (75%).38 Ongoing advancement of this technology should be aimed at improving precision in order to achieve the significant benefit of accurate, timely hemoglobin measurements without the need for blood draws. Research continues on functional noninvasive hemodynamic monitoring, with the goal of determining whether patients will be volume-responsive without the use of an invasive catheter or an esophageal Doppler probe.39 The ccNexfin (Edwards Lifesciences) is a noninvasive hemodynamic monitoring system about which there are numerous reports in the peer-reviewed literature, such as in goal-directed fluid therapy during moderate- to high-risk surgery40 and for hemodynamic management during electroconvulsive therapy in a patient with an unrepaired abdominal aortic aneurysm41 (Figure 6). The device also demonstrated promising results in a study of hemodynamic stability to improve perioperative outcomes during spinal anesthesia for cesarean delivery.42
Smartphones and Mobile Devices The ubiquity of the smartphone has driven the steady development of monitoring devices that interface with smartphones. A device that integrates a pulse oximeter with a smartphone has been shown to provide a portable, at-home screening tool for intermittent hypoxia in children with sleep-disordered breathing.43 A low-cost version of this device has been proposed as a solution for monitoring children with diseases such as pneumonia in low- and middle-income countries.44 A novel method for noninvasive measurement of blood glucose concentration using a smartphone has also been described in the literature.45 Smartphone electrocardiogram single-lead devices accurately detect baseline intervals as well as atrial rate and rhythm, enabling screening in diverse populations.46 Some of these applications of smartphone monitoring technology are considered medical devices and thus are subject to FDA approval. A smartphone can be useful to the anesthesia provider even without attached patient monitoring devices. A study showed that pediatric patients who were distracted with a smartphone app had anxiety scores that were lower than similar patients who were randomized to receive midazolam instead.47 Smartphone apps designed for pediatric anesthesia48 are available for download, but a recent review of painrelated apps found multiple areas for improvement.49 Perioperative crisis event management and education apps are also available for free download.50,51
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Future Directions This review is not an exhaustive description of the ongoing convergence of technology and anesthesiology, and many important topics not discussed here (eg, robotic anesthesia, teleanesthesia) have been the subjects of lengthy review articles.52,53 In the future, these technological advances will be increasingly complementary and interoperable, so that anesthesia providers will use EHRAIMS to document an anesthetic in a patient whose preoperative vital signs and lab values were assessed with his smartphone and a wearable noninvasive monitoring bracelet. A preoperative airway exam will have been performed using smartphone-based telemedicine. Smart pumps, computer-controlled infusions, and barcode technology have made medication errors almost-never events; on the rare occasions when such errors occur, sophisticated monitoring systems alert the clinician while also providing patient- and medication-specific decision support.
The rapid pace of development of consumer technology has great potential to merge commercial products into anesthesia practice and education. Will wearable health monitors be used as gauges of cardiovascular tolerance? Will virtual reality headsets enhance anesthesia education and simulation exercises, and might they be used routinely for preoperative anxiolysis in patients? Discovering the answers to these questions will be an exciting endeavor indeed.
ACKNOWLEDGMENTS The authors thank their colleagues and fellow members of the Society for Technology in Anesthesia, many of whom have published works that are cited as references in this manuscript, and Mohamed A. Rehman, MD, for his mentorship and guidance during the writing of this article.
Figure 6. The ccNexfin Hemodynamic Monitoring System. The ccNexfin is a noninvasive answer to functional monitoring.
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2. Ehrenfeld JM, Rehman MA. Anesthesia information management systems: a review of functionality and installation considerations. J Clin Monit Comput. 2011;25(1):71-79. 3. Stabile M, Cooper L. Review article: the evolving role of information technology in perioperative patient safety. Can J Anaesth. 2013;60(2):119-126. 4. Kadry B, Feaster WW, Macario A, et al. Anesthesia information management systems: past, present, and future of anesthesia records. Mt Sinai J Med. 2012;79(1):154-165. 5. Wax DB, Beilin Y, Levin M, et al. The effect of an interactive visual reminder in an anesthesia information management system on timeliness of prophylactic antibiotic administration. Anesth Analg. 2007;104(6):1462-1466. 6. Spring SF, Sandberg WS, Anupama S, et al. Automated documentation error detection and notification improves anesthesia billing performance. Anesthesiology. 2007;106(1):157-163. 7. Chau A, Ehrenfeld JM. Using real-time clinical decision support to improve performance on perioperative quality and process measures. Anesthesiol Clin. 2011;29(1):57-69. 8. Nair BG. Development and use of the Smart Anesthesia Manager (SAM) - An AIMS based real-time decision support module. The Society for Technology in Anesthesia 2015 Annual Meeting. http://www.stahq.org/index.php/download_file/view/541/75/. Accessed February 24, 2015. 9. Nair BG, Peterson GN, Newman SF, et al. Improving documentation of a beta-blocker quality measure through an anesthesia information management system and real-time notification of documentation errors. Jt Comm J Qual Patient Saf. 2012;38(6):283-288. 10. Nair BG, Peterson GN, Neradilek MB, et al. Reducing wastage of inhalation anesthetics using real-time decision support to notify of excessive fresh gas flow. Anesthesiology. 2013;118(4):874-884. 11. Nair BG, Horibe M, Newman SF, et al. Anesthesia information management system-based near real-time decision support to manage intraoperative hypotension and hypertension. Anesth Analg. 2014;118(1):206-214. 12. Guffey P. Driving reporting and quality improvement. The Society for Technology in Anesthesia 2015 Annual Meeting. http://www. stahq.org/index.php/download_file/view/545/75/. Accessed February 24, 2015.
19. White RW, Tatonetti NP, Shah NH, et al. Web-scale pharmacovigilance: listening to signals from the crowd. J Am Med Inform Assoc. 2013;20(3):404-408. 20. Orser BA, Hyland S, U D, Sheppard I, Wilson CR. Review article: improving drug safety for patients undergoing anesthesia and surgery. Can J Anaesth. 2013;60(2):127-135. 21. Merry AF, Webster CS, Hannam J, et al. Multimodal system designed to reduce errors in recording and administration of drugs in anaesthesia: prospective randomised clinical evaluation. BMJ. 2011;343:d5543. 22. Ang SB, Hing WC, Tung SY, et al. Experience with the use of the Codonics Safe Label System(™) to improve labelling compliance of anaesthesia drugs. Anaesth Intensive Care. 2014;42(4):500-506. 23. Jelacic S, Bowdle A, Nair BG, et al. A system for anesthesia drug administration using barcode technology: the Codonics Safe Label System and Smart Anesthesia Manager™. Anesth Analg. 2014. [Epub ahead of print] 24. BD Intelliport Medication Management System. http://www. bd.com/intelliport/products/. Accessed February 24, 2015. 25. Sandler SG, Langeberg A, Dohnalek L. Bar code technology improves positive patient identification and transfusion safety. Dev Biol (Basel). 2005;120:19-24. 26. Nuttall GA, Abenstein JP, Stubbs JR, et al. Computerized bar code-based blood identification systems and near-miss transfusion episodes and transfusion errors. Mayo Clin Proc. 2013;88(4):354-359. 27. Peterfreund RA, Philip JH. Critical parameters in drug delivery by intravenous infusion. Expert Opin Drug Deliv. 2013;10(8):1095-1108. 28. Ohashi K, Dalleur O, Dykes PC, et al. Benefits and risks of using smart pumps to reduce medication error rates: a systematic review. Drug Saf. 2014;37(12):1011-1020. 29. Bartels K, Moss DR, Peterfreund RA. An analysis of drug delivery dynamics via a pediatric central venous infusion system: quantification of delays in achieving intended doses. Anesth Analg. 2009;109(4):1156-1161. 30. Parker MJ, Lovich MA, Tsao AC, et al. Computer control of drug delivery by continuous intravenous infusion: bridging the gap between intended and actual drug delivery. Anesthesiology. 2015;122(3):647-658.
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14. Laney D. 3D data management: controlling data volume, velocity, and variety. http://blogs.gartner.com/doug-laney/files/2012/01/ ad949-3D-Data-Management-Controlling-Data-Volume-Velocityand-Variety.pdf. Accessed February 24, 2015.
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33. Görges M, Westenskow DR, Markewitz BA. Evaluation of an integrated intensive care unit monitoring display by critical care fellow physicians. J Clin Monit Comput. 2012;26(6):429-436.
16. Dutton RP. Quality management and registries. Anesthesiol Clin. 2014;32(2):577–586. 17. Shapiro FE, Jani SR, Liu X, et al. Initial results from the National Anesthesia Clinical Outcomes Registry and overview of officebased anesthesia. Anesthesiol Clin. 2014;32(2):431-444. 18. Kheterpal S, Healy D, Aziz MF, et al. Multicenter Perioperative Outcomes Group (MPOG) Perioperative Clinical Research Committee. Incidence, predictors, and outcome of difficult mask ventilation combined with difficult laryngoscopy: a report from the Multicenter Perioperative Outcomes Group. Anesthesiology. 2013;119(6):1360-1369.
34. Masimo Acoustic Respiration Rate (RRaTM). http://www.masimo. com/rra/. Accessed February 24, 2015. 35. Frasca D, Geraud L, Charriere JM, et al. Comparison of acoustic and impedance methods with mask capnometry to assess respiration rate in obese patients recovering from general anaesthesia. Anaesthesia. 2015;70(1):26-31. 36. Atkins JH, Mandel JE. Performance of Masimo rainbow acoustic monitoring for tracking changing respiratory rates under laryngeal mask airway general anesthesia for surgical procedures in the operating room: a prospective observational study. Anesth Analg. 2014;119(6):1307-1314. 37. Marques NR, Kramer GC, Voigt RB, et al. Trending, accuracy, and precision of noninvasive hemoglobin monitoring during human hemorrhage and fixed crystalloid bolus. Shock. 2014. [Epub ahead of print]
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