Dec 2014 by McMahon Group

GENERALSURGERYNEWS.COM

December 2014 • Volume 41 • Number 12

The Independent Monthly Newspaper for the General Surgeon

Opinion

Promise of EMR Systems Yet To Be Fulfilled for Many

Medicine and the Internet

Main Gripes: Divided Attention, More Work, Cost B Y C LAIRE C RONIN , MD, MBA

New Tool Estimates Risks For Patients Having Sleeve Gastrectomy

B Y V ICTORIA S TERN

y son received his first phone for his 13th birthday in February. By the end of March, the phone had spent more time in a locked drawer due to inappropriate online use than it had in my son’s company. We tried to explain to him that everything he posts is out there for everyone to see forever, especially because he has a unique name. When he got it back in April, his Instagram account was cancelled along with some other “insta” apps. Summer came and my husband and I eased up on monitoring my son’s phone partly out of laziness and partly because we were afraid of what we would find.

I am starting to suspect that those ‘best doctor‘ ads in the airline magazines may not be real either.

B Y K ATE O’R OURKE

or more than a decad de, electronic medical record ds (EMRs) have been calleed a critical step forward in modern medicine. Th he idea was that transition ning from paper to electron nic records would increasse efficiency, safety and savvings in health care. Th he potential for EMRs to make patient records more accessible, reduce medical errors, allow medical institutions to communicate more seamlessly and save the health care industry billions of dollars each year was too tempting to pass up. Despite this, the reality of EMRs

s it time for me to retire? I am going to think it through and make my decision right here, right now, on these pages, while you watch. This is better than reality television; this is reality writing and reading. At the end, I will make my decision.

see INTERNET page 20

INSIDE In the News

Surgeons’ Lounge

In the News

Report from IFSO: Endoluminal Devices Seek Place at Table for Weight Loss Therapy

Physically, I am sitting at the Los Angeles farmer’s market with my wife Marcelle. Mentally, I am at the intersection of “am I still relevant? and “should I retire?” I think that there are more than a few of you stuck at a similar intersection. I am young (insert your own age see RETIRE page 16

see SLEEVE RISK page 14

seems not to have lived up to the hype. EMR systems have been costly to implement and are often laborious and see EMR page 8

Why Don’t I ‘Just Retire’? B Y G ARY H. H OFFMAN , MD

The bliss of ignorance was shattered when my 11-year-old daughter, who does not own a phone, informed us that our son had posted a love note to his girlfriend through a new Instagram account that had no privacy settings. This was a bit of a surprise because in addition to not being allowed to post on Instagram, he isn’t allowed to have a girlfriend. When

BOSTON—Investigators have developed a calculator for estimating early postoperative morbidity and mortality in patients undergoing laparoscopic sleeve gastrectomy (LSG). The use of LSG for the treatment of obesity is rapidly growing in popularity. A recent systematic review demonstrated that LSG resulted in a loss of more than 50% of excess weight in the long term (five or more years postoperatively), and a considerable improvement or even remission of comorbidities (Surg Obes Relat Diss 2014;10:177-183). Current models for estimating the risk for patients undergoing LSG are inadequate, according to Ali Aminian, MD, a bariatric surgeon from the Cleveland Clinic, Ohio, who presented the data at Obesity Week. For example, the well-known Obesity Surgery Mortality Risk Score is limited because it is based on old data, considers only 12 baseline variables, combines open an nd laparoscopic procedures and d is only applicable to gastric bypass. Dr. Aminian and his colleagues extracted data on morbidly obese patients undergoing LSG in 2012 from the American College of Surgeons National Surgical Quality Improvement

A case of papillary thyroid carcinoma

Be Prepared for Electronic Record Breaches, Experts Warn

Is It All in My Head or Real?

Healthier Outcomes All Around

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GSN Editorial

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / DECEMBER 2014

The Power of Observation Frederick L. Greene, MD, FACS Clinical Professor of Surgery UNC School of Medicine Chapel Hill, North Carolina

s we became involved in the clinical side of medicine, even as neophytes beginning our medical school core rotations, we were introduced to the concept of “rounding.” This ritual not only gave us a perspective on patient issues, but also served as a tremendous learning tool as we collected pearls of wisdom strewn before us by our seniors. Daily rounds also created a team mentality and forged a cohesive approach that served as a template for planning diagnostic and management strategies and, more importantly, gave our patients the benefit of realizing that a whole team was interested in getting them well. During my academic surgical career, one of my greatest pleasures was to round with medical students and surgical residents. It was always a pleasure to have the floor nurses join us, but the changes that have occurred in nurse–physician interactions have unfortunately altered

this opportunity for team building. While participating on rounds, I always tried to emulate some of the best teaching techniques learned from my professors and the surgical residents senior to me. Although a great deal of learning occurred in the hallway, the real essence of making rounds for me was to enter our patients’ rooms and to have some meaningful dialogue. An additional challenge relating to these patient encounters was to interact with the patient, family members and friends. I had the privilege and good fortune, early in my surgical career, to see these episodes handled both beautifully and clumsily. From my early experience, I began to appreciate how important it was just to observe the surroundings in a patient’s room. How did the patient look? Did he or she have a pained or unhappy expression, or did our patient smile and want to engage with the team? Were family members or friends present? Could we engage them in some way or just ignore their presence as I had seen done many times before? Were cards or flowers in the room? Commenting on these expressions of love and hope always made our

The most important part of rounding was the opportunity to listen to our patient. patients feel better and gave them a sense that we cared. The most important part of rounding was the opportunity to listen to our patient. Observing emotions relating to an already performed or upcoming surgical procedure gave a valuable opportunity to assuage fear, if not during rounds, perhaps later in a less congested environment. The team could ask, “How are you doing today?” or “What can we do to make you more comfortable today?” Holding a patient’s hand is one of the most meaningful expressions of caring. In our desire to avoid transmission of organisms, the avoidance of patient contact has unfortunately become paramount. Remember, this is the reason we have hand foam and disinfectant at every patient’s door! My concern is that the positive aspects of hospital rounds have been supplanted

by the exigencies of the 80-hour workweek, over-attentiveness to the electronic health record, the proliferation of midlevel providers, fractionation of the physician–nurse collaboration, administrative workload and other challenges that surgeons face in community and academic practices. For me, rounding provides so many positive benefits, the most important of which are to observe and interact with patients and to use these encounters to bond with patients and caregivers while instructing our juniors in the art of surgery. In 1927, Dr. Francis W. Peabody opined: “One of the essential qualities of the clinician is interest in humanity, for the secret of the care of the patient is caring for the patient.” By making effective, interactive and meaningful rounds, we show our hospitalized patients that we care and that we are listening.

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In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / DECEMBER 2014

HER2+ Metastatic Breast Cancer

‘Dramatic’ Data Establish Pertuzumab as Part of Standard Regimen B Y T ED B OSWORTH MADRID—In patients with HER2-positive metastatic breast cancer (HER2+ mBC), the new standard of care is chemotherapy and trastuzumab plus pertuzumab, according to a substantial overall survival (OS) benefit found in a multinational Phase III trial. After a median follow-up of 50 months, median survival increased by more than one year compared with chemotherapy and trastuzumab alone. When pertuzumab was added to treatment, “the median survival was 56.5 months, which is unprecedented and confirms this regimen as first-line therapy,” reported Sandra M. Swain, MD, medical director of the Washington Cancer Institute at MedStar Washington Hospital Center, in Washington, D.C. Dr. Swain presented the final OS analysis of this trial, called CLEOPATRA, at the 2014 Congress of the European Society for Medical Oncology (ESMO; abstract 350O PR). In this study, which included participants from 204 centers in 25 countries, 808 patients with HER2+ mBC were randomized to receive pertuzumab (Perjeta, Genentech) in an 840-mg loading dose followed by a 420mg maintenance dose, or placebo. All patients received trastuzumab (Herceptin, Genentech), in an 8-mg/kg loading dose followed by a 6-mg/kg maintenance dose, plus at least six cycles of docetaxel (75 mg/m2 titrated to

100 mg/m2 if tolerated). The advantage of pertuzumab over placebo for progression-free survival (PFS) was reported previously (N Engl J Medd 2012;366:109-119). In the survival curves presented at ESMO, the benefit of pertuzumab emerged within the first year. After a median follow-up of 50 months, the median survival was 56.5 months in the arm that received pertuzumab versus 40.8 months in the placebo arm. The median 15.7-month increase in survival generated a hazard ratio of 0.68, or a 32% reduction in the risk for death (P=0.0002). P The extended safety analysis is consistent with safety data reported earlier. The rates of diarrhea (68% vs. 48%), rash (37.5% vs. 24%), mucositis (27% vs. 19%) and headache (25% vs. 19%) were higher with the addition of pertuzumab, but most adverse events were grade 2 or lower. There was no sign of increased cardiovascular risk with the two HER2 dimerization inhibitors combined. The trial was characterized as “an unquestionable

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therapeutic success” by Luca Gianni, MD, director of medical oncology at the San Raffaele Scientific Institute, in Milan. Invited by ESMO to put these results in perspective, Dr. Gianni called the more than oneyear improvement in OS “dramatic,” and suggested that this provides a new paradigm for treating HER2+ mBC. The trial data confirm that “dual HER2 blockade is feasible and safe,” Dr. Gianni said, noting that HER2positive disease represents about 20% of breast cancers. He said he believes that the next step in HER2+ mBC will be to individualize therapy by targeting mediators of resistance, such as mutations in the PIK3CA A gene. However, he said he considers the CLEOPATRA data to be definitive. “The combination of pertuzumab, trastuzumab and docetaxel is not just an option for the first-line treatment of HER2+ metastatic breast cancer,” Dr. Gianni said. “It is the new standard.” Dr. Swain is an uncompensated consultant for Genentech/Roche. Dr. Gianni has financial relationships with AstraZeneca, BioScience, Boehringer Ingelheim, Celgene, Genentech, GlaxoSmithKline, Pfizer, Roche and Tahio.

Procedure Paired With Sleeve Gastrectomy Offers Bridge to Heart Transplants B Y L OUISE G AGNON MONTREAL—A novel procedure dubbed the “sleeve of life” has patients undergo the placement of a left ventricular assist device (LVAD) in conjunction with a laparoscopic sleeve gastrectomy as a transition to a heart transplant. Developed by researchers at the University of Texas, Houston, the procedure has been performed in four men ranging in age from 27 to 57, all of whom were morbidly obese with heart failure and other comorbidities, such as hypertension, diabetes and obstructive sleep apnea. The physicians presented data on the cases in an oral session at the International Federation of Surgery for Obesity and Metabolic Disorders. “These are patients who have no other [treatment] options,” said Kulvinder S. Bajwa, MD, FACS, assistant professor, Department of Surgery, Minimally Invasive Surgeons of Texas, University of Texas Health, Academic Center in Houston. “They are not considered for [heart] transplantation because they are morbidly obese. This is a bridge to transplantation.”

The procedure aims to achieve significant weight loss, a major drop in body mass index and resolution of comorbidities, such as diabetes, in patients. To date, the youngest patient who underwent LVAD followed by sleeve gastrectomy has been placed on a list for a heart transplant. Because of its lack of malabsorption, the procedure is preferable over gastric bypass, according to Dr. Bajwa. Its absence would produce the least risk for affecting absorption of antirejection medications that would be required after transplant, he continued. Another advantage of performing a sleeve gastrectomy as a bariatric procedure in conjunction with placement of the LVAD is that patients can continue to be on anticoagulant therapies if they are warranted. It is more technically challenging to perform a laparoscopic sleeve gastrectomy after LVAD than as a single procedure, so the combined procedure should be reserved for more experienced hands, said Shinil K. Shah, DO, assistant professor, Department of Surgery, Division of Elective General Surgery, University of Texas Medical School in Houston, and a gastrointestinal surgeon.

In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / DECEMBER 2014

Endoluminal Devices Seek Place at Table for Weight Loss Therapy B Y L OUISE G AGNON MONTREAL—Somewhere between medical therapy and established bariatric surgical options, patients are looking for alternative interventions for weight loss, and endoluminal or endoscopic approaches appear to represent those alternatives. At the 2014 meeting of the International Federation of Surgery for Obesity and Metabolic Disorders (IFSO), Erik Wilson, MD, medical director of bariatric surgery at Memorial Hermann Texas Medical Center and chief of elective general surgery at the University of Texas Health Science Center at Houston, discussed the design of and preliminary findings from the Primary Obesity Multicenter Incisionless Suturing Evaluation, or the PROMISE trial. The trial involves endoscopic sleeve plication and the OverStitch Endoscopic Suturing System (Apollo Endosurgery Inc.), a device approved for endoscopic placement of sutures and stitching together of soft tissue, said Dr. Wilson, one of the trial investigators. The procedure aimed at gastric restriction involves no surgical incisions, with the procedure done through the mouth. The trial involved 20 patients at each of four U.S. centers, including Massachusetts, Florida, Texas and New Jersey. Patients recruited for the study had a body mass index (BMI) between 30 and 35 kg/ m2, and were followed in regular clinical visits every three months up to one year after the procedure, with an endoscopic evaluation at 12 months. “The primary end point is to see if it is safe and if it’s doable, to determine the efficacy, and to see the potential durability as well,” Dr. Wilson said. “There is some space between medical therapy and some of the surgical therapies as far as invasiveness and risk profile,” Dr. Wilson said at a symposium sponsored by Apollo Endosurgery Inc., about options for weight loss treatments in patients with lower BMIs. “Some of the endoscopic procedures fit in this area. Our goal is to try to plicate the stomach with an endoluminal approach.” Patients may be challenged to lose weight through medical therapy, that is through dietary restrictions and lifestyle modifications, and they may want to avoid more invasive approaches, such as a gastric bypass, laparoscopic adjustable gastric banding or sleeve gastrectomy, according to Dr. Wilson. The durability, however, of the endoluminal procedure remains to be seen. “We can’t say that it will last for years and years,” Dr. Wilson said. “If you can do something endoluminally that will last one to two years, be revisable, keep options open for other therapies, and you select your patients appropriately, it is probably something worth considering.” To date, the PROMISE trial investigators have not observed any major morbidity or mortality and no major bleeding events that required a transfusion, and there has been no need for operations after the procedure, Dr. Wilson said. Two patients were excluded during the trial because of pregnancy. “We are seeing about a 43% excess weight loss,” he said. “The average BMI of the patients in the trial is 33 [kg/m2].” Although Dr. Wilson did not say the procedure is contraindicated in patients who have a BMI of 40 kg/m2 or greater, he said the outcomes would likely be

The OverStitch Endoscopic Suture System for gastric sleeve plication was studied in the PROMISE trial.

The EndoBarrier is a duodenal–jejunal bypass liner designed to imitate the duodenal–jejunal exclusion of the Roux-en-Y gastric bypass.

“disappointing” in patients with higher BMIs when comparing outcomes in weight loss with established surgical options. “We should keep it for lower BMI ranges,” he said. The National Institutes of Health had originally set out guidelines for bariatric surgery that excluded patients with BMIs below 35 kg/m2, with the exception

outpatient setting. One option is an intragastric balloon, such as the ReShape Duo, a dual intragastric balloon intervention, or the Orbera intragastric balloon (Apollo Endosurgery Inc.). Both systems are currently under review with the FDA. Although the balloon avoids possible complications linked to established surgical techniques, it has not been demonstrated to have long-term benefit after removal of the device, according to Dr. de la Cruz-Munoz. “Because it is an endoscopic procedure, it’s lower risk,” Dr. de la Cruz-Munoz said in an interview. “That makes it an advantage, but it has to be removed after several months, so there is a concern about what is the long-term efficacy.” The EndoBarrier (GI Dynamics), a duodenal– jejunal bypass liner (DJBL), is approved for oneyear treatments, is designed to imitate the duodenal– jejunal exclusion of the RYGB, and has been used in many countries such as the United Kingdom, France, Italy, Denmark and Chile. One of the key benefits associated with the procedure is a significant decline in HbA1c (glycosylated hemoglobin) measures and glycemic control, according to Jan Willem Greve, MD, in the Department of Surgery, University Hospital Maastricht, the Netherlands. “It’s placed and removed endoscopically quite easily,” Dr. Greve said, but added that perforation of the esophagus has occurred with the device in two cases. “The most significant complication reported has been bleeding, in 1.6% of cases, followed by migration of the device, in 1.3% of cases.” The device can be re-implanted, so that if patients gain weight after explantation, they can be offered the therapy again and return to their initial post-treatment weight, Dr. Greve said. In terms of the pool of patients, Dr. Greve described good candidates for the DJBL device as patients with a BMI of 30 to 40 kg/m2 who also have diabetes. The American Society for Gastrointestinal Endoscopy and the American Society for Metabolic and Bariatric Surgery created a task force to examine endoscopic treatments for obesity and released a white paper on the topic, entitled “A Pathway to Endoscopic Bariatric Therapies,” in 2011.

‘If you can do something endoluminally that will last one to two years, be revisable, keep options open for other therapies, and you select your patients appropriately, it is probably something worth considering.’ —Erik Wilson, MD

of patients who had severe diabetes, or hemoglobin A1c higher than 9%. Patients with lower BMIs are suitable candidates for endoluminal bariatric therapies, with more established surgical options like the Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy being reserved for patients with low BMIs who present with a comorbidity, according to Nestor de la Cruz-Munoz, MD, FACS, associate professor of clinical surgery, University of Miami Miller School of Medicine, in Florida. “If [patients] have low BMIs, but they are sicker patients, then it is worth it to perform stapling procedures in them because it produces better results,” said Dr. de la Cruz-Munoz. “They [RYGB and sleeve gastrectomy] are more effective in the resolution of comorbidities and weight loss [than gastric banding or endoluminal approaches].” Endoluminal bariatric options are attractive for patients because they can be performed in the

In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / DECEMBER 2014

Quality-of-Care Measures in Acute GI Bleeding Cuts Hospital Stay B Y T ED B OSWORTH

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CHICAGO—In patients with acute gastrointestinal bleeding, meeting qualityof-care indicators reduces length of stay in the hospital, a study has found. The retrospective study, involving 700 patients, is consistent with a series of other initiatives suggesting that adhering to and documenting quality indicators improves outcomes in practice.

The quality indicators most associated with a reduced length of stay (LOS) were performance of orthostatics in patients with normal vitals, placement of large-bore IV lines and appropriate deployment or non-deployment of hemostasis, said Carl Nordstrom, MD, chief GI fellow in the University of California, Los Angeles’ integrated gastroenterology training program. Of the 26 quality indicators that were considered, adherence to eight

was evaluated, according to Dr. Nordstrom, who presented the findings at Digestive Disease Week 2014 (abstract 330). In addition to the four indicators most closely associated with LOS, these included appropriate documentation of nasogastric lavage findings, admission of hypovolemic patients to an ICU, endoscopy within 24 hours and use of a large-bore therapeutic endoscope. The patients were treated over a 10-year period (1996-2007) at a single Veterans

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Affairs medical center. In general, the greater the number of quality indicators met, the shorter the hospital stay, the researchers found. This included a significant difference in the average stay between those in whom a single quality indicator was met and those without any documented quality indicators (6.5 vs. 10 days; P=0.003). P Although the difference for those in whom four to six quality indicators were achieved was only marginally better than for those with one to three, the average stay for those in whom all eight quality indicators were met was only four days. The researchers found no association between quality indicators and a patient’s risk for death, but incremental increases in the number of quality indicators performed were linked to a substantial reduction in the need for a second endoscopy in addition to the reduction in LOS. “There is a large variation in the process of care among institutions for acute gastrointestinal bleeds,” Dr. Nordstrom said. He suggested that these data provide evidence that the quality indicators could reduce hospital stays, if not improve overall outcomes in gastrointestinal (GI) bleeds, but cautioned that these findings “should be confirmed in a prospective study.” Using quality indicators to guide care is a growing phenomenon. In colonoscopy, for example, some third-party payors are considering documentation of quality indicators, such as an endoscope withdrawal time of at least six minutes, for reimbursement. In managing GI bleeds, however, Dr. Nordstrom said prospective evidence is needed to show that adhering to such indicators affects outcomes. James Scheiman, MD, professor of gastroenterology at the University of Michigan, in Ann Arbor, said it is critical to demonstrate that establishing these kinds of processes of care actually changes physician behavior. “Is it that quality indicators matter or do better doctors do better with quality indicators?” he asked. He expressed concern about “pop up” reminders in electronic medical record systems calling for physicians to perform quality measures not yet proven to affect outcome. Improving processes of care must be aligned with incentives in an integrated health care system that both encourages and facilitates physicians to adhere, Dr. Scheiman said. Quality indicators are useful and have the potential to improve outcomes while reducing cost, he added, but their real value emerges “if we can get people who are not very good at this to do it better.” Dr. Nordstrom reported no relevant financial conflicts of interest. Dr. Scheiman has financial relationships with AstraZeneca, Pfizer, Pozen and Stryker.

In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / DECEMBER 2014

Random Biopsies Help Detect Recurrent Esophageal Metaplasia B Y T ED B OSWORTH CHICAGO—In patients who have undergone ablative removal of esophageal lesions, random biopsies detect more recurrent metaplasia than targeted surveillance based on endoscopic signs, new research shows. Suspicious mucosal changes leading to a targeted biopsy also were an important predictor of recurrence in the study—increasing the odds ratio by 17.7fold (P<0.001) relative to the absence of a suspicious lesion—but random biopsies led to identification of a greater number of recurrences even if most were of lower grade, the researchers found. “In addition to taking biopsies of suspicious lesions, these data support the value of random biopsies to increase detection of recurrent metaplasia,” said Sarina Pasricha, MD, a fellow in the Division of Gastroenterology and Hepatology at the University of North Carolina (UNC) at Chapel Hill. Dr. Pasricha presented the data on behalf of an investigative team led by Nicholas J. Shaheen, MD, director of the UNC Center for Esophageal Diseases and Swallowing. The relative value of random biopsies was not trivial. According to data presented at Digestive Disease Week 2014 (abstract 106), 74% of the recurrences were detected during random biopsies, leaving only 26% detected when endoscopic signs, such as nodules or suspicious changes in surface appearance, prompted a targeted biopsy. For the single-center study, the researchers reviewed the medical records of all patients who underwent radiofrequency ablation for Barrett’s esophagus (BE) at the institution’s hospitals between 2006 and 2013. The analysis was restricted to the 168 patients who achieved complete eradication of BE and had undergone at least two surveillance endoscopies. In addition to targeted biopsies during routine endoscopic surveillance, random biopsies were performed every 1 cm in a standard fourquadrant protocol. The researchers identified 19 (11%) histologic recurrences of intestinal metaplasia in the tubular esophagus. Patients who experienced a recurrence underwent a mean of 3.8 surveillance endoscopies. The 14 patients with a randomly detected recurrence were somewhat older and had fewer endoscopies than the five patients with a recurrence found on a targeted biopsy. But the major difference was the type of recurrence. “In those [recurrences] detected with a random biopsy, 70% of the recurrences involved intestinal metaplasia or

low-grade dysplasia,” Dr. Pasricha said. “In those detected with a targeted biopsy, 80% had high-grade dysplasia or adenocarcinoma [P=0.016].” The researchers pointed out that 80% of the recurrences were identified within 1 cm from the top of the gastric folds (Z line). This included all of the targeted biopsies. Of recurrences found with random biopsies, two were seen in areas of esophagitis, which may

have concealed irregularities in the tissue, but the majority of the others were located in normal-appearing tissue. One of the random biopsies did identify adenocarcinoma, according to the researchers. No subsquamous recurrences were found. In a discussion that followed presentation of the data, several members of the audience commented about the high rate of recurrences located close to

the Z line. This pattern of recurrence led to speculation that ablation did not extend far enough toward the gastroesophageal junction. Although this did not challenge the basic study conclusion regarding the value of random biopsies, which did identify recurrences more than 1 cm away from the distal fold, it did raise questions about how far to extend radiofrequency ablation in standard ablative procedures.

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

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• First cycle deadline is in early February 2015. • Second cycle deadline is in early April 2015.

In the News EMR

jcontinued from page 1 confusing to learn. There is no universal system that all physicians can use; instead, medical professionals are faced with more than 100 systems, all competing for users and many of which cannot communicate with one another. But perhaps most notably, these systems do not appear to improve patient care, as promised, and in some cases may make care worse. Nevertheless, the use of EMRs has ballooned in the past 10 years. In 2005, fewer than 25% of physicians’ offices and

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / DECEMBER 2014

hospitals had adopted an EMR system, but today more than 80% use one. Despite the rapid spread, the central concerns about EMR systems remain the same: high cost, lack of standardization and interoperability, privacy issues and inferior patient care (Health Afff 2005;24:1103-1117). But even before this spike in usage, many medical professionals were already well aware of the issues. In a 2004 report, researchers who had conducted 90 interviews with EMR managers and physicians found that “most physicians using EMRs spent more time per patient for a period of months or even years after EMR

Of physicians who opted not to purchase an EHR system, the top reason was that the technology would interfere with the doctor–patient relationship. implementation. The increase resulted in longer workdays or fewer patients seen, or both, during that initial period …. Most respondents or their colleagues considered even highly regarded,

industry-leading EMRs to be challenging to use because of the multiplicity of screens, options and navigational aids” (Health Afff 2004;23:116-126). In a 2013 survey conducted by RAND Health, and sponsored by the American Medical Association, physicians echoed many of the same sentiments. In fact, physicians rated EMRs as a main reason for their job dissatisfaction. Summing up the results of the report, the RAND researchers wrote: “Despite recognizing the value of EHRs [electronic health records] in concept, many physicians are struggling to use their EHRs, which they describe as negatively impacting patient care in several important ways and undermining their professional satisfaction.” In the study, the authors interviewed 24 practices about EHRs, 22 of whom were currently using a system. On the plus side, about one-third of the physicians reported that the EHR improved their job satisfaction and 61% said it improved quality of care. These physicians noted that their EHR system enhanced their abilities to access patient data at work and at home, provided guideline-based care and tracked patients’ disease. In contrast, many physicians also expressed concerns over their EHRs, with about 20% saying they would prefer to return to paper charts. The central issues boiled down to inferior patient interactions, an inability to exchange information between different systems and a laborintensive and time-consuming learning curve and data entry. “Just because something is more expensive doesn’t mean it’s better,” said Peter Kim, MD, associate professor of surgery, Albert Einstein College of Medicine of Yeshiva University, New York City, who was not involved in the study. “For instance, the EMR giant Epic received $302 million from New York City, in 2013, for use in about 11 New York City public hospitals. But even within the same system, not all Epic EMRs are alike. An EMR’s functionality depends on who is programming it as well as the local needs of the institution. The same system may end up working well in one hospital, but poorly in another.” Although people often assume that technology will reduce errors, that also is not the case. “In our hospital, administrators try to make our EMR sound perfect, but in reality, we have encountered huge errors and have had no audits of the system,” said Guy Voeller, MD, FACS, professor of surgery at the University of Tennessee Health Science Center, Memphis. Along these lines, Dr. Kim recalled an incident when a toxic drug dose was written for the wrong patient, which missed all of the EMR system’s checks and balances. “Although that error could have happened with the old system, it wasn’t prevented by

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GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / DECEMBER 2014

the EMR as it should have been,” Dr. Kim said. “We still need that human element in care, where a person is checking and verifying orders.” Regarding patient interactions, physicians in the RAND study who complained that EHRs interfered with in-person patient care found that they were forced either to divide their attention between the patient and the computer or to give patients their attention but then spend hours inputting data afterward. “With EHRs, physicians and nurses are looking at a computer screen and have their backs to the patient,” said Dr. Voeller. “Physicians and nurses are forced to devote time to their computer, not their patient.” Another report revealed similar results. A team at Medscape surveyed 18,575 physicians in 25 different specialties from April 9, 2014, to June 3, 2014, about their EMR use. Of those, 4%, or 743 participants, were general surgeons. The report found that about one-third of respondents felt their EHR systems worsened clinical operations and patient services, although about the same percentage reported the opposite. In terms of patient interactions, 70% of respondents said their system decreased their face-toface time with patients and 57% said it lessened their ability to see patients, while about one-third felt their system enhanced their ability to respond to patients and effectively manage treatment plans. Patient privacy was another major worry for physicians, approximately half of whom expressed concern about losing patient information because of a technological malfunction or about their lack of control over who can access patient data. About 40% of participants were also concerned about HIPAA compliance and hackers getting to data. Similarly, of physicians who opted not to purchase an EHR system, the top reason was that the technology would interfere with the doctor–patient relationship (40% of responses). The other most frequent complaints were that EHR systems are too expensive (37%), and that the incentives and penalties from the Centers for Medicare & Medicaid Services are not worth the hassle of adopting a system (32%). Other reasons were that EHRs hurt patient privacy (22%) and were too complicated to learn (16%). The financial burden of EMRs appeared to be increasing as well. According to the Medscape survey, in 2014, 23% of respondents said their EHR system cost $50,000 or more per physician to purchase and install, whereas in 2012, only 7% of respondents said their EHR system cost that much. Another report that evaluated the cost of EHRs, using survey data from 49 community practices in a large EHR pilot project, found that “the average physician would lose $43,743 over five years; just 27% of practices would have achieved

a positive return on investment; and only an additional 14% of practices would have come out ahead had they received the $44,000 federal meaningful-use incentive” (Health Afff 2013;32:562-570). Currently, Dr. Kim said, the federal government is forcing institutions to have an EMR system, which is driving many physicians out of business and into a hospital on a salary or into retirement. “Besides the cost of implementation, evidence already is accumulating that doctors order more—not fewer—imaging studies when [an] EMR is used,” wrote David Cossman, MD, a vascular surgeon

in Los Angeles, in a 2012 piece in General Surgery News (May 2012, page 1). As for billing, Dr. Voeller noted, “the way we bill through EMRs lends itself to fraud because physicians can document more complex visits that come with a higher price tag and reimbursement.” Amid the confusion and ambivalence, some surgeons are holding out hope that as companies iron out the kinks in the current systems, EMRs may eventually live up to the early hype. Others remain skeptical that there is a magic bullet that will vastly simplify and improve EMRs. Reflecting on the current state of the

technology, Dr. Cossman wrote: “The big problem is that HAL [the sinister computer in Stanley Kubrick’s film “2001: A Space Odyssey”] is once again stalking us with the sweet siren song of untold efficiencies, cost containment and protection from human fallibility if we only move over to the passenger seat and let it drive. Don’t believe a word of it. Medicine cannot be practiced on autopilot. We will crash and burn without the human touch at the controls.”

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GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / DECEMBER 2014

Two Studies Support Value of Bariatric Accreditation Failure To Rescue Is Key Finding B Y C HRISTINA F RANGOU as the Centers of Excellence proJust gram in bariatric surgery enters its second decade, two large studies report that accreditation has led to safer outcomes, lower mortality, shorter hospital length of stay and lower total charges after bariatric surgery.

“These two studies show that accreditation saves lives, reduces readmission, lowers cost. Across the board, we’ve seen that,” said John M. Morton, MD, MPH, chief of bariatric and minimally invasive surgery, Stanford School of Medicine, Stanford, Calif., and president-elect of the American Society for Metabolic and Bariatric Surgery (ASMBS). Dr. Morton, who authored one of the studies, is the national co-chair of the Metabolic and Bariatric Surgery

Accreditation and Quality Improvement Program (MBSAQIP), the accreditation program created by the American College of Surgeons and the ASMBS. In Dr. Morton’s study, investigators studied nearly 120,000 bariatric patient discharges from 235 unique hospitals in the Nationwide Inpatient Sample for 2010. They found that, compared with accredited centers, unaccredited institutions had a higher mean length of stay

(LOS; 2.25 vs. 1.99 days; P<0.0001) and greater total charges ($51,189 vs. $42,212; P<0.0001). Complications occurred more often at unaccredited centers (12.3% vs. 11.3%; P P=0.001). In a multivariable logistic regression analysis, unaccredited status was identified as a significant predictor of complications (odds ratio [OR], 1.08; P<0.0001) and mortality (OR, 2.13; P=0.013). P At least eight other studies have shown that patients benefit from surgery at accredited centers, although two studies have called into question the value of the accreditation program. What sets this most recent study apart from earlier research is that it is the first to look at accreditation and failure-torescue rates in bariatric surgery. The investigators found that failure-to-rescue rates nearly doubled at unaccredited centers, reaching 0.97% compared with 0.55% at accredited centers. The investigators attributed the difference to the “enhanced ability of accredited centers to recognize and rescue patients with complications.” Dr. Morton added that he believed accreditation aids all obese patients, not just bariatric patients.

‘The accrediting body already did the homework for the patient. The patient essentially needs to ask only one question: Is this an MBSAQIPaccredited center?’ —Ninh T. Nguyen, MD The study was published this fall in Annals of Surgeryy and presented at this year’s 134th annual meeting of the American Surgical Association ((Ann Surg 2014;260:504-508; discussion 508-509). A second study, published in the September edition of the Journal of the American College of Surgeons, reported that outcomes of bariatric surgery in Medicare beneficiaries improved substantially after 2006, when the Centers for Medicare & Medicaid Services (CMS) issued a National Coverage Determination requiring bariatric procedures to be performed only at accredited centers ((J Am Coll Surg g 2014;219:480-488). Analysis showed that the percentage of Medicare patients who had serious complications decreased from nearly 10% between 2001 and 2005 to less than 7% between 2006 and 2010. On average, hospital LOS decreased from four days to three days during those periods, the study data showed.

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GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / DECEMBER 2014

In a key finding, Medicare patients had a 59% reduced chance of dying from bariatric surgical complications after the 2006 implementation of the CMS policy compared with the preceding period (0.23% mortality in 2006-2010 vs. 0.56% previously). Serious morbidity also dropped significantly, from 9.92% to 6.98%, after the CMS accreditation requirement. Non-Medicare patients experienced improved outcomes over the same period, with a reduction in in-hospital mortality from 0.18% to 0.08% (P<0.01) and serious morbidity, which fell from 6.84% to 5.08% (P<0.01). However, the improvement in patient outcomes was most pronounced at accredited centers, the investigators noted. Compared with patients who underwent stapling bariatric procedures at accredited centers, patients treated at unaccredited centers had a significantly higher risk-adjusted in-hospital mortality (OR, 3.53; 95% CI, 1.01-6.52) and serious morbidity (OR, 1.18; 95% CI, 1.07-1.30). “I suggest that patients considering a bariatric operation look for, and go to, an accredited bariatric center,” said study co-investigator Ninh T. Nguyen, MD, professor of surgery and chief of the Gastrointestinal Surgery Division, UC Irvine Health, in Orange, Calif. “The accrediting body already did the homework for the patient. The patient essentially needs to ask only one question [to learn the facility’s capabilities]: Is this an MBSAQIP-accredited center?” Although the Centers of Excellence program has been criticized in the past as restrictive, expensive and bureaucratic, it is also widely credited with raising the bar for bariatric surgery in the United States. Even hospitals that do not have centers of excellence status improved patient outcomes and data collection since 2004, studies have shown. Today, patient outcomes at both accredited and unaccredited centers are quite good, with greatly reduced mortality and complication rates compared with a decade ago. Any differences in patient outcomes at accredited and unaccredited centers, although statistically significant, are “tiny” clinically, several surgeons pointed out. “The differences that we see are pretty minimal. The mortality rate [at unaccredited centers] is still very low, lower than colon resections for diverticulitis, yet nobody questions the validity of that particular operation,” said Timothy J. Pitchford, MD, a bariatric surgeon at the Marshfield Clinic, Eau Claire Center, in Eau Claire, Wisc. His center is not accredited, although Dr. Pitchford performs 80 to 100 bariatric operations annually. As the only bariatric surgeon at his hospital, the center’s

‘The whole idea that you can’t do surgery unless you’re accredited is frustrating because we have good volumes for one surgeon with low mortality and low morbidity. We have no deaths, going on nine years.’ —Timothy J. Pitchford, MD volume had been too low to qualify for accreditation under the old ASMBS criteria. “The whole idea that you can’t do surgery unless you’re accredited is frustrating because we have good volumes for one surgeon with low mortality and low

morbidity. We have no deaths, going on nine years,” he said. Despite his frustration with the discrepancy, Dr. Pitchford supported the Center of Excellence concept. “It’s good in that it forces people to

submit their data and has helped bariatric surgery achieve the status where we can now go to companies and say, ‘this is what we can do with bariatric surgery now.’” Today, his practice is constrained by tight restrictions on coverage and misperceptions about bariatric surgery other than accreditation status, he said. “There’s still this idea that people can just diet their way to a healthier lifestyle, and that’s not the case.” Currently, more than 700 bariatric surgery centers throughout the United States are accredited or seeking accreditation through the MBSAQIP.

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Indications: Intended for implantation to reinforce soft tissue where weakness exists and for surgical repair of damaged or ruptured soft tissue, including: abdominal plastic and reconstructive surgery; muscle ﬂap reinforcement; hernia repair including abdominal, inguinal, femoral, diaphragmatic, scrotal, umbilical, and incisional hernias. The Rifampin and Minocycline coating has been shown in preclinical in vitro and in vivo testing to reduce or inhibit microbial colonization in the device. The claim of reduction of bacterial colonization of the device has not been established with human clinical data, nor has a clinical impact associated with this claim been demonstrated. Contraindications: 1. XENMATRIX™ AB Surgical Graft should not be used on patients with known sensitivity to porcine products. 2. Do not use in patients with allergy, history of allergy or hypersensitivity to tetracyclines or rifamycins or other components in the device. 3. Do not use in pregnant or nursing women. 4. The contraindications, warnings and precautions regarding the use of the antimicrobial agents Rifampin (a derivative of rifamycinB) and Minocycline (a derivative of tetracycline) apply and should be considered when using this device. See FDA’s drug labeling database for Rifampin and Minocycline labeling.

The use of this product in patients with compromised hepatic function should be carefully considered since rifampin can cause additional stress to hepatic metabolism. Implantation of this device would not result in detectable systemic concentrations of Rifampin or Minocycline. Warnings: 1. This device is not indicated for the treatment of infection. If an infection develops, treat the infection aggressively. 2. To minimize recurrences when repairing hernias, the graft should be large enough to provide sufficient overlap beyond the margins of the defect on all sides. 3. An allergic reaction that is unrelated to other therapy is an indication to consider removal of XENMATRIX™ AB Surgical Graft. Precautions: 1. Do not alter practice of pre-, peri-, or postoperative administration of local or systemic antibiotics. Adverse Reactions: Potential complications with the use of any prosthesis may include, but are not limited to, allergic reaction or hypersensitivity to device materials or antimicrobial coating, seroma, infection, inflammation, adhesion, fistula formation, erosion, hematoma, and recurrence of tissue defect.

Surgeons’ Lounge

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / DECEMBER 2014

Welcome to the December issue of The Surgeons’ Lounge. In this last issue of the year, we welcome our guest expert Anna Kundel, MD, assistant professor of surgery, Division of Endocrine Surgery, NYU Langone Medical Center, New York City. Dr. Kundel discusses a case of papillary thyroid carcinoma. Also, take the Surgeon’s Challenge: How would you manage this patient? Look for the answer in the January 2015 issue. Be our next expert!! We look forward to receiving your responses to the case presented in the October 2014 issue, and you could be featured as our next “Guest Expert” in the January 2015 issue. Dr. Szomstein n is associate director, Bariatric Institute, Section of Minimally Invasive Surgery, Department of General and Vascular Surgery, Cleveland Clinic Florida, Weston.

Question for Anna Kundel, MD Ariel Shuchleib Postgraduate Year 3 surgery resident, New York Hospital Medical Center of Queens, Weill Cornell Medical College, New York City

73-year-old man had a papillary thyroid carcinoma initially identified two years ago on physical examination. This was confirmed on biopsy, but he was subsequently lost to followup until now. He had never taken thyroid medication but does not have any symptoms of hyper- or hypothyroidism. He denies having difficulty swallowing, breathing, or having pain in the lower neck. He does, however, report a change in his voice that was noticed recently. On physical examination, there is a visible large left neck mass extending laterally with overlying skin changes concerning for dermal invasion. The trachea is deviated to the right (Figure 1). There is no evidence of palpable cervical lymphadenopathy on the right. The patient is euthyroid. Imaging studies that included non-contrast (creatinine 2 mg/dL) computed tomography (CT) scan of the neck, chest and positron emission tomography (PET) scan showed an 8-cm left lobe mass extending to left lateral neck (Figure 2). There were no other suspicious findings or evidence of metastatic disease. A repeat ultrasound (US)-guided fine needle aspiration (FNA) was performed and was

W ishing all our readers happy and safe holidays, and look forward to another year of your questions and comments. Sincerely, Samuel Szomstein, MD, FACS Editor, The Surgeons’ Lounge Szomsts@ccf.org

consistent with the initial diagnosis of papillary thyroid carcinoma (Figure 3). Preoperative laryngoscopy revealed normal functioning vocal cords. The patient underwent en bloc resection of the thyroid, overlying skin and left modified radical neck dissection that included resection of the encased internal jugular vein and sternocleidomastoid muscle. The recurrent laryngeal, vagus and accessory nerves were preserved, with their function confirmed by intraoperative nerve monitor. The defect was closed with a pectoralis muscle flap. Pathology revealed an 8.5-cm papillary thyroid carcinoma with tall cell variant with angioinvasion, extraglandular, subcutaneous and perithyroidal soft tissue extension associated with desmoplastic response (Figure 4). Three of the six lymph nodes were positive for metastasis, making the tumor stage IVA (T4a N1bM0). Postoperative testing showed Ca/PTH (calcium/parathyroid hormone) 9.5/19 and thyroglobulin (Tg) of 30, and diagnostic whole-body scan revealed a small focus in the thyroid bed with no evidence of distant metastatic disease. The patient is scheduled to receive a therapeutic dose of radioactive iodine. Questions: What is the initial workup for a patient with such a presentation? What is the role of preoperative laryngoscopy? What are the surgical options for this patient? What is the appropriate postoperative surveillance for this patient?

Figure 1. The trachea is deviated to the right.

Figure 2. PET scan showed an 8-cm left lobe mass extending to left lateral neck.

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search for metastatic disease. With a large thyroid tumor and a notable voice change, the patient should certainly undergo preoperative laryngoscopic evaluation of his vocal cords. Answer to Question 2 A history and a physical examination are the best initial screening tools to assess the voice. Either the surgeon Answer to Question 1 identifies hoarseness or there is usually a history of voice Patients with this presentation, who had a workup sev- change that is noted by the patient or a family member. eral years before, should be reevaluated from the begin- In general, laryngoscopic evaluation should be done on a ning. This includes functional, anatomic as well as tissue case-by-case basis. I do not advocate routine preoperaassessment. At minimum, thyroid function tests and a tive screening. Preoperative laryngoscopy should be perneck US should be done to evaluate the thyroid mass and formed in patients with: bilateral central and lateral lymph node basins. The main • Prior neck surgery where an injury to the recurrent concern in a patient with such an extensive tumor burlaryngeal or vagus nerve could have occurred, as in den is a change in biology from papillary to poorly difprevious thyroid, parathyroid, cervical esophageal, ferentiated carcinoma. Therefore, a repeat FNA or core cervical spine or vascular surgery; biopsy is essential in planning the next step in manage• A history or presence of hoarseness on physical ment. Although core biopsy is not routinely performed exam or a report of recent voice change; for diagnosis, in this case a tissue sample can identify • A thyroid gland with extensive anatomic distortion, anaplastic cancer and spare the patient surgery. such as tracheal deviation where the nerve could Similarly, it is important to obtain current imaging to have been stretched; assess anatomy. Intravenous contrast may delay admin• Aggressive tumors with evidence of local invasion. istration of radioactive iodine postoperatively. However, This patient would definitely require evaluation of when the tumor is thought to be aggressive, as in this case, his vocal cords given the large size, voice change and my preference is to obtain a CT scan with IV contrast to evidence of invasion on imaging. Of note, I also do not look for evidence of vascular extrathyroidal invasion and routinely perform postoperative laryngoscopy. Most help determine the extent of resectability. If creatinine is postoperative hoarseness is transient. Permanent vocal elevated, then a non-contrast CT scan can still provide cord paralysis occurs in less than 1% of patients when ample information. I would also obtain a PET scan to the operation is performed by an experienced surgeon. Patients who are persistently hoarse after a month, or who have decreased quality of life as a result of their hoarseness, may benefit from early cord medialization. This treatment can relieve symptoms and restore phonation, even if this is a transient occurrence. Answer to Question 3 At this time, the current American Thyroid Association guidelines recommend total thyroidectomy for tumors larger than 1 cm. Prophylactic central neck dissection (level VI) is still controversial, but should be performed in large tumors with evidence of aggressive behavior. Prophylactic lateral neck dissecFigure 3. Ultrasound-guided fine needle aspiration biopsy was pertion without evidence of nodal involveformed and results were consistent with the initial diagnosis of ment is not recommended. Patients with papillary thyroid carcinoma. preoperatively identified positive lymph nodes on imaging and fine needle biopsy or during surgery should undergo therapeutic systematic lymph node clearance. There is no role for cherry picking. Modified radical neck dissection refers to dissection of lateral lymph node basin levels II through V, where the spinal accessory nerve, internal jugular and/ or sternocleidomastoid muscle are preserved whenever possible to decrease morbidity. Patients with advanced tumors, such as the one presented here, require expert surgical skills. An en bloc resection of the thyroid with tumor and invaded extrathyroidal tissues with thorough bilateral central and left modified radical neck dissection gives this patient Figure 4. Pathology revealed an 8.5-cm papillary thyroid carcinothe best chance at clearing the disease. ma with tall cell variant, with angioinvasion and extraglandular, Answer to Question 4 subcutaneous and perithyroidal soft tissue extension associated For such large aggressive tumors, with desmoplastic response. patients are managed postoperatively

Dr. Kundel’s

with radioactive iodine and thyroxin suppression therapy. Postoperative surveillance is multifactorial. Thyroglobulin levels are used to evaluate presence of persistent disease or to identify recurrence. Initial measurements are typically done at six to eight weeks after surgery to establish a baseline. At this time, if patients are receiving radioactive iodine (RAI), their thyroid-stimulating hormone (TSH) levels are elevated (via withdrawal of thyroxin or recombinant TSH injections), providing the result of stimulated Tg levels. After RAI therapy or ablation, ideally there would be undetectable suppressed serum Tg levels. It is important to check levels of anti-Tg antibodies (TgAb), as their presence falsely lowers serum Tg. If the antibodies are present, I trend the levels and use them as surrogate markers of disease. Poorly differentiated cancers, however, may not give an elevated level of either stimulated or suppressed Tg. This may lead to a false sense of tumor clearance. Therefore, it is imperative that a US of the neck is done to evaluate residual or recurrent disease in the thyroid bed and central and lateral compartment lymph nodes. Patients with positive TgAb should be followed with cervical US, and strong consideration should be given to obtaining a whole-body scan at one year. Once the disease is stable or undetectable, Tg and TgAb levels should be checked six months and one year after surgery in combination with cervical US. I continue to trend levels every six months for five years. I perform cervical US yearly in high-risk patients if Tg levels are stable. When serum Tg is elevated, a US should be performed and suspicious nodes or tissue biopsied. If there are increasing Tg levels and a negative US, a whole-body scan may be useful for radioiodine-avid tumors. When a whole-body scan is negative, a fluorodeoxyglucose–PET scan can be used for localization.

References 1. Cox A, LeBeau SO. Diagnosis and treatment of differentiated thyroid carcinoma. Radiol Clin N Am. 2011;49:453-462. 2. Schlosser K, Zeuner M, Wagner M, et al. Laryngoscopy in thyroid surgery—essential standard or unnecessary routine? Surgery. 2007;142:858-864. 3. Hayward NJ, Grodski S, Yeung M, et al. Recurrent laryngeal nerve injury in thyroid surgery: a review. ANZ J Surg. 2013;83:15-21. 4. American Thyroid Association Surgery Working Group. Consensus statement on the terminology and classification of central neck dissection for thyroid cancer. Thyroid. 2009;19:1153-1158. 5. Bilimoria KY, Bentrem DJ, Ko CY, et al. Extent of surgery affects survival for papillary thyroid cancer. Ann Surg. 2007;246:375-381. 6. Gemsenjäger E, Perren A, Seifert B, et al. Lymph node surgery in papillary thyroid carcinoma. J Am Coll Surg. 2003;197:182-190. 7. Spencer CA. Challenges of serum thyroglobulin (Tg) measurement in the presence of Tg autoantibodies. J Clin Endocrinol Metab. 2004;89:3702-3704. 8. Chiovato L, Latrofa F, Braverman LE, et al. Disappearance of humoral thyroid autoimmunity after complete removal of thyroid antigens. Ann Intern Med. 2003;139:346-351. 9. Bannas P, Derlin T, Groth M, et al. Can (18)F-FDGPET/CT be generally recommended in patients with differentiated thyroid carcinoma and elevated thyroglobulin levels but negative I-131 whole body scan. Ann Nucl Med. d 2012;26:77-85. 10. Kresnik E, Gallowitsch HJ, Mikosch P, et al. Fluorine18fluorodeoxyglucose positron emission tomography in the preoperative assessment of thyroid nodules in an endemic goiter area. Surgery. 2003;133:294-299.

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SLEEVE RISK

The Surgeonâ&#x20AC;&#x2122;s Challenge Case prepared in collaboration with Jacqueline Wilneff, MD candidate, Class of 2016, Charles E. Schmidt College of Medicine, Florida Atlantic University, Boca A 66-year-old woman with a past medical history significant for a 40 pack-year smoking habit with chronic obstructive pulmonary disease, hypertension and diabetes mellitus, presented to our clinic with a recurrent ventral hernia and non-healing midline wound. Her past surgical history includes cholecystectomy, exploratory laparotomy for perforated diverticulitis with colostomy that required a prolonged ICU stay, tracheostomy and posterior reversal of colostomy. The patient had undergone three previous ventral hernia repairs, with the last repair for recurrence six months before presenting to our clinic. She reported fatigue and significant weight gain, but denied nausea or vomiting, abdominal pain or change in bowel habit. Her vital signs were within normal limits, and she had a body mass index of 29.28 kg/m2. Abdominal examination revealed multiple

scars, midline exposed mesh and active secretion of purulent material without erythema. Multiple hernia defects were noted (Figure). Laboratory test results were within normal limits. How would you manage this patient?

Figure. Multiple hernia defects were noted.

jContinued from page 1 Program database to develop the calculator, which is available online. This database prospectively collects information on more than 150 variables, including demographics, comorbidities, laboratory values and 30-day postoperative mortality and morbidity outcomes for patients undergoing major surgical procedures in the United States. The investigators included patients who underwent concurrent endoscopy, liver biopsy, abdominal wall hernia repair, hiatal hernia repair, cholecystectomy and procedures to manage intraoperative complications. They excluded patients who underwent revisional bariatric procedures and cases with unrelated concurrent procedures, such as appendectomy and hysterectomy. Cases of LSG in 2011 were used to examine the validity of the risk model. The investigators conducted univariate and multivariate analyses on 52 baseline variables to explore risk factors associated with mortality and a 30-day postoperative composite adverse event (AE), including mortality. The composite AE was defined as the presence of any of 14 serious AEs, such as deep vein thrombosis, pulmonary embolism and myocardial infarction (Table). For the 5,871 patients who underwent LSG in 2012, the composite AE rate was 2.4% and mortality rate was 0.05%. â&#x20AC;&#x153;The data point to the overall safety of LSG as a treatment for severe

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GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / DECEMBER 2014

Table. 30-Day Postoperative Composite Adverse se Event 1. Organ/space surgical site infection 2. Stroke 3. Coma 4. Myocardial infarction 5. Cardiac arrest 6. Deep vein thrombosis 7. Pulmonary embolism

obes ob esit es itty, y,”” Dr Dr. Am Amin inian in nia i said. “Incidence o alll of th of t e in iindividual d complications, exxce cept pt pos o to toperative op bleeding, was no grea gr eate ea terr than te tha 0.5% in this series.” th The Th he researchers identified seven major riiisk skk factors for post-LSG serious AEs: history of congestive heart failure, steh roid use for chronic conditions, male sex, diabetes, preoperative serum total bilirubin level, body mass index (BMI) and low preoperative hematocrit level. The risk factors were used to develop a model of estimated risk. Tests showed the model had a good calibration on the Hosmer-Lemeshow goodness-of-fit test with a χ2 of 16.02 (P=0.591) P and a moderate discrimination (C-statistic 0.682). The model was then validated on a dataset of patients who underwent LSG in 2011 and showed a relatively similar performance (C-statistic 0.63). Dr. Aminian cited several patient examples. The estimated risk in a healthy woman with a BMI of 38 kg/m2 and hematocrit of 42% would be 1%. The estimated risk in a woman with a BMI of 60 kg/m2, with diabetes, history of chronic steroid use (e.g., for asthma or rheumatoid arthritis) and hematocrit of 44% would be 12.6%. “Estimating the risk for postoperative adverse events can improve surgical decision making and informed patient consent,” he said. Additionally, considerable benefit can be gained by identifying potentially modifiable preoperative factors that are associated with increased risk for postsurgical adverse events. “Preoperative optimization of patients with symptomatic heart failure may reduce the risk for elective surgery,” Dr. Aminian said. “Chronic steroid use can impair the healing process and increase infectious complications. Conservative perioperative and intraoperative measures in such patients with immunosuppression may diminish surgical risk.” A user-friendly online version of the risk calculator is available at http://rcalc. ccf.org. When the required patient values are entered into the calculator, the percent estimate of serious AEs after LSG is calculated.

8. Reintubation n 9. Mechanica cal ventilation >48 h 10. Sepsis sis 11. Sept eptic shock 12.. N Need for transfusion 13. Acute renal failure 13 14. Death

Wayne English, MD, a bariatric surgeon at Vanderbilt nd der erb b University Medicall Ce ca Cent Center, ntter er,, in i N Nashville, Tenn., who serv se rved rv ed as a di d scussant of the study affte terr it i wass p presented, said he was a “f “fir irm ir m be beli liiever” in using surgical risk ri skk-p sk-p -pre redi re diction models and was di im mpr pres esse es seed with the new calcula cu lato la torrr. “This will improve to th he informed consent proc sss, help to identice fy high-risk patients fy aand it certainly can

help optimize patients prior to surgery. [However], it is unfortunate that [the researchers] didn’t have data to identify what are already well-known risk factors for surgery, such as prior history of VTE [venous thromboembolism] and the breakdown of pulmonary disease, obstructive sleep apnea and procedure time. In addition, surgeon skill factor needs to be taken into consideration as we move forward.” Drs. Aminian and English reported no relevant financial relationships.

Opinion RETIRE

jcontinued from page 1 here). I still see many patients each day. I teach. I operate. I invent. I wake up early just to get my preliminary professional and personal work done, and I go to bed long after the fourth rerun of the cable news. Then, I wake up and do it again. And I am content. I am happy. There is no burning need to retire. My hands are solid and my mind, except for occasionally not remembering why I just walked into a room, is fast and sharp. Why am I even thinking about retirement? Why

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / DECEMBER 2014

now? Is it my age and the natural desire to plan for the future, or is it the tumultuous state of American health care delivery? The inner drumbeats calling for me to retire from this cacophony grow louder and stronger. I want out! Here are the issues that will frame my decision. Some are good but most are not so good.

The ‘Old Man’ and His Young Son I am fortunate to be involved in my private practice with a group of fine surgeons and terrific physicians. I watch them work, grow and evolve. I learn from

them and they learn from me. They push me and they challenge me. Each day, one or all of them playfully refer to me as “the old man” (insert your own age here). They mean it lovingly, or so they tell me. I also teach the colorectal fellows in our fellowship. A certain energy and vigor permeate this work as it is more fun than work. I am sure that the fellows also make reference to my seniority. Thankfully, however, this is done behind my back. Finally, I am lucky to be able to watch my son Jordan, as he progresses through his surgical training and learns new skills and ideas on a daily basis.

Setting New Standards Through Innovation

Should I become a yearly pencil pusher and remain certified or retire and escape from the nonsense? Retirement is beginning to feel pretty good. Put a check in the retirement column. He is in a fabulous surgical residency at Emory University and is light-years ahead of where I was at the same stage of training. He also pushes me, challenges me and weighs me against his professors and mentors to see if I measure up (so far I seem to be holding my own). I challenged my father, a beloved community colorectal surgeon, in the same way. This is the nature of the game, but prodding me toward the end game is this future generation of young surgeons, challenging my abilities and relevance. As long as I remain vital I can put a check mark in the ‘do not retire’ column.

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To continue in the “good” column, the surgical robot teases me (and mind you, the robot represents just one of many interesting challenges that force all surgeons to question themselves in the light of ever-expanding technology). Will it amount to anything or will it be an expensive boondoggle? I don’t know, but the desire to try new things, to remain relevant and on the forefront of surgical care still burns strong within me. Can an old dog climb the learning curve of new tricks? The robot represents another challenge to my personal relevance in our rapidly evolving surgical armamentarium, and a step further down the retirement road if I turn away from new technologies. Will I rise to the challenges or will I retire? I seem to like technical challenges and the constant learning necessary to master new procedures. Another check in the ‘do not retire’ column.

Maintenance of Certification I am board-certified until 2017, at which time I must start Maintenance of Certification, beginning with the recertification exam. I am not too worried about the test. I am, however, bothered about all of the subsequent paperwork and waste of time, which proves nothing and guarantees little. However, if I turn away from board certification, I would be an “uncertified” surgeon, and society loves certification. Should I become a yearly pencil pusher and remain certified or retire and escape from the nonsense? Retirement is beginning to feel pretty good. Put a check in the retirement column.

Opinion

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / DECEMBER 2014

A Well-Meaning Friend and Abraham Flexner How does my old pal Richard fit in here? Richard, who is often the devil’s advocate in our heated conversations, has been harping on me for 30 years about the ills that befall society when medicine and money collide. It isn’t a pretty sight (or so he says). And yes, I can see some of the damage that can be done. I can see how the decision-making process can be corrupted and skewed. Richard doesn’t like what he sees in modern American health care delivery. He, like everyone else with an opinion, constantly screams (or at least speaks forcefully) about the collective ills and ailments of monetized American medicine. “But,” I always respond, “we have to pay the rent for our offices. We have to pay our bills. Rents are going up. Reimbursements are going down. What kind of business model is this anyway?” Add in the plaintiff ’s malpractice attorneys portraying physicians and hospitals as one of the seven deadly sins (or sinners), and I add another check in the retirement column. At this point, and seemingly from out of the blue, the 1910 Flexner report popped into my mind. I hopped on the Internet and found the report. The report examined the decline of medical education, and attributed some of the decline to the normal, yet destructive effects money might have on the medical decision-making process. Patients. Money. Well-meaning friends. Bills. Flexner. Why don’t I just retire? Escape. Get Richard off my back and Flexner out of my head. Ah, Rio de Janeiro (insert your own nirvana location here). Add another check for retirement. I am so out of here!

Learn. Work. Retire. Playing Center Field for the Dodgers While sitting in the farmer’s market, I ran into a former patient whom I had not seen in many years. A nice and mellow guy. We talked about the kids, life and about his retirement. He loves retirement and he casually suggested that I “just retire.” “You will love it,” he said. “You won’t have to work anymore,” he concluded. He told me that he, like many people, had disliked work from the beginning. I smiled and walked back to talk with Marcelle and asked her whether I should “just retire.” I would periodically look up at my patient as I began my rambling, vaguely directed toward my wife, about retirement, about how physicians, both young and old, are the hardest-working people I know. About how they adhere to rigorous standards of self-examination and self-criticism while pursuing the elusive goal of perfection. About how I have trained my entire life to practice the art

and craft of surgery. About how surgery is more than just a job and about how money never entered into my thoughts about my future career when I was a young, brash medical student on a trajectory to becoming a surgeon. For me, the operating room and all that leads up to it, is like playing center field for the Dodgers. Pure joy. What must it be like, I wondered, to train for a job solely to make money, and then simply quit when the bank account allowed for it? Boring and uninspired. “Born to retire” has never been my motto or my goal. I love what I do. Here is my personal mathematical

formula: OR = (Heaven)∞. What I do is not work. It is pure. It is heaven. Most people work. I get to play center field in the Cedars-Sinai operating rooms. So, if all of this noise and the nonsense cause me to leave that which I love, if I quit, if I bench myself, I will be leaving my dream. A difficult decision, for sure.

Surgery and medicine are all that I know and all that I have lived. My father lived it, I live and my son is living it. For me, surgery is the perfect calm.

Peace and Quiet By the time I had finished pondering all of this, I could feel my diastolic pressure intersecting my systolic pressure and then climbing above it. A remarkable physiologic event for sure. And

then sudden calm. Why don’t I just retire? How easy would that be? Peace, quiet, tranquility. Why not? Why don’t see RETIRE page 18

Opinion RETIRE

jcontinued from page 17 I just retire? Retirement feels to be the best option. “Serenity now,” to reference Frank Costanza.

Surgery: The Perfect Calm Pausing, staring out to nowhere and looking inward while sitting next to my wife, I make up my mind. I quit. I have made the decision to “just retire.” Too many check marks in the retirement column. DONE. PEACE. CHECK. And then I hear my father’s voice,

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / DECEMBER 2014

Memories of Guatemala

telling me to tune out the nonsense and to take control of the game. Decide based on my wishes, based on my desires and on my concerns. If I am to retire, do so on my terms, at a time of my choosing and in the manner that I wish to retire. Has my personal expiration date truly arrived? I refocus, tune out the outside noise and try it again. A typical surgeon and Norman Hoffman’s son. Don’t quit until you are sure that it is right. Do it again. Try to remember why I became a surgeon in the first place. Rethink it until it looks right and is right. Do it again.

And then, I remember. What about the work that my son and I do together in Guatemala? What about having improved lives so immediately and visibly for those people who have next to nothing? When in Guatemala, Jordan and I (and the entire team) are able to change the world, one person at a time. I could see it and feel it, with a view unobstructed by bureaucrats, paperwork, computers, office rent or any other nonsense. Surgery and medicine are all that I know and all that I have lived. My father lived it, I live it and my son is living

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Pausing, staring out to nowhere and looking inward while sitting next to my wife, I make up my mind. I quit. I have made the decision to ’just retire.’ Too many check marks in the retirement column. DONE. PEACE. CHECK.

it. For me, surgery is the perfect calm. It exists separate from the disharmony and dysfunction that represent “modern” American health care delivery. Surgery is what I do. Surgery is what I think about. Surgery is what I still love. A surgeon is who I am. Guatemala on my mind. Surgery in my heart. I am a surgeon. I am.

Ayn Rand and the Monkeys

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My memory kicks in and the feel of surgery ignites, unfettered by mental clutter. The memory, the feel and the love. The privilege and honor that I have been given. The work that I have done, and still do. All of it. And just like that, I know that retirement now is not even a question. I still love it. To leave now, to walk away from this heaven feels ludicrous. What I feel is at odds with what seems to be going on around me, and around all physicians. I am fine, but the inmates are running the asylum. The monkeys have gained control of the zoo. That thought is not original with me. Ask Ayn Rand. For now, there is no amount of anything that can be dumped on my head to force me to retire. I will think about

Opinion

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / DECEMBER 2014

If you are a surgeon, you will know it. You will not have to think about it. You will have no choice. You will feel it. are a surgeon, or you are not a surgeon. Absolutely, unequivocally and wholeheartedly love the art, the craft and the science of surgery. Love everything about surgery. If you are a true surgeon, you will not care about working long hours. You

will strive for perfection and accept nothing short of perfection. And, when you fail, you will examine yourself first to find the cause of the failure. You will ignore the current lunacy that passes for public discourse and discussion about health care and medicine. You know right from wrong. And, if you do not agree with me here, then do something elseâ&#x20AC;&#x201D;anything else. A forced life as a surgeon will crush you. Run in the opposite direction from the operating room. However, if you choose to follow the dream of becoming a surgeon, the joy, the fun and the love of all things surgical will

sustain you when everything else screams â&#x20AC;&#x153;just retire!â&#x20AC;? I am done writing this piece. I am going to the operating room. I am. Check. â&#x20AC;&#x201D;Dr. Hoffman is attending surgeon in â&#x20AC;&#x201D; the division of colorectal surgery at CedarsSinai Medical Center, and attending surgeon in the division of general surgery and associate clinical professor of surgery at the David Geffen School of Medicine, University of California, Los Angeles. He is a senior member of Los Angeles Colon and Rectal Surgical Associates.

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)NVITED 3PEAKERS )NVITED 3PEAKERS retirement. I will plan for it. I will brace myself for it. But, barring unforeseen circumstances, I will not be forced out by a dysfunctional system, or by well-meaning friends and patients, or by any concerns other than my natural abilities and my desire to continue to practice that which I loveâ&#x20AC;&#x201D;surgery. For me, surgery is the perfect calm. I will retire when I am ready to retire. In the meantime, I will continue to read and write about surgery, dream about it, and I will operate. I am not retiring today, this year, or anytime soon. I love surgery. I love what I do. I get to play center field for Los Angeles Colon and Rectal Surgical Associates. Am I a surgeon? I am. And, I am still young (insert your own age here).

Unsolicited Advice My unsolicited suggestion to young physicians who are pondering a life in surgery is this: If you are a surgeon, you will know it. You will not have to think about it. You will have no choice. You will feel it. The choice cannot be forced by looking at a list of all of the medical specialties and simply picking surgery from the list. You

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Opinion INTERNET

jcontinued from page 1 confronted with the evidence, he admitted that he thought no on ne would be able to trace it back to him because he had cleverly changed d his account name from “JohnDoe” to “NotJohnDoe” (his real name is changed to protect the innocent). I just need to take a moment here to point out that raising a son answers eveerything anyone ever wanted to know about men. If only I knew back in college what I know now! I would have skipped over my fascinatioon with the strong silent types where I waited breathlessly for them to say something deep bu ut they never did because they had nothing to say. I would also like to suggest that my 11-year-old d daughter be the next director of the Secret Serviice. This whole episode made me thin nk twice about what I was doing to manage my own online presence as a surgeon. I have a new office websitee with a half-decent picture and an up-to-date curriculum vitae. Aside from some high school pictures used for a reunion, I don’t post on Facebook. I tried Twitter a few times but I don’t have the heart for it or, for that matter, any followers. I had the benefit of growing up before the Internet so there are no embarrassing frat party pictures or declarations of love. There is a really awkward big hair 1980s rock video on YouTube but I am referred to only as “the bar babe” in the comments. Occasionally I have the urge to write back, “that’s Dr. Bar Babe to you, buddy,” but then I risk discovery. One of the good things about working in the Boston area is that nothing ever changes here. For example, it is still perfectly OK to throw the occasional stapler at a resident or ask a vascular fellow to stand in the corner for the duration of a fem-pop in some of the major teaching hospitals. A significant number of surgeons have yet to adopt laparoscopic surgery and jokingly refer to their open cases as single-port surgery that guarantees six weeks off work. There are a few robots in hospitals around town, but only a handful of urologists know how to use them, so they are mostly used to hang dry-cleaning on. In Boston, we are not the innovators or even the early adopters of new technology and this includes the Internet. I don’t advertise because, well, we don’t do that here. When I travel to Florida, I am equally awed and disgusted by the ads for physicians. It seems like a lot of effort and money goes into maintaining that kind of public presence. That’s another thing about Boston— we are Puritan cheap and the idea of spending money on ads is incomprehensible. As I was writing this, I saw an 89-year-old patient of mine in follow-up. She is still active and has a slightly older boyfriend who she likes to travel with, as well as a much older husband in a nursing home, but that is another story. She started the visit off with how upset she was with her PCP [primary care physician] for referring her to a certain specialist. I told her that I knew him and thought highly of his operative skills and asked her what the issue was. She said in disgust, “He advertises!” I could have kissed her but I held off the impulse to inquire further into her distress. “Well, it’s just not done,” she said. “It’s unprofessional. He should go by his reputation.” I hugged her when she left, clearly getting more out of the visit than she did. I am just starting to understand that those top Boston

A physician’s reputation will soon be directly proportional to the skill of his or her public relations directors and not to his or her actual ability or caring attitude.

physician lists are not based on any quality data, which explains how certain nonpracticing physicians make the list every year. They are voted in by their friends. The last time I was in my husband’s dental practice, he had a new plaque on the wall declaring him the No. 1 dentist in the area. I congratulated him on his award and he told me he bought it from a company for a few hundred dollars. He proudly told me that his patients love it. I am starting to suspect that those “best doctor” ads in the airline magazines may not be real either. A few years ago, I went on one of those rate-my-physician websites, and after 12 years of practice I had five or six anonymous ratings. A few of the posts were just plain nasty and my feelings were hurt, so I have avoided looking at them to this day. When I Google another doctor’s office, I now have to wade through three pages of these websites before I can find their contact information. Most of these sites are devoid of any valuable information. Unlike my ostrich-like behavior, one of my partners was energized by a post by an unhappy patient on one of these sites that said he “treated her like a barnyard animal.” He now asks his grateful patients to go on certain sites and rate him. Other practices are handing out cards to patients that give detailed instructions on how to access their preferred rating company along with an encouragement to rate them highly. I understand that areas outside of Boston are probably adept at managing their Internet reputations, but we are just coming to terms with this now. Patients are becoming savvier and doing their research before they come into the office. Many of them know of my interests, writings, and on one occasion my golfing handicap before meeting me. My problem is that it feels forced. Sort of like when patients ask us to read affirmations in the operating room, which come out a tad sarcastic, saying that their operation will be a success and afterward they will pee freely while enjoying a delicious pear, instead of the genuine words of encouragement that come from the heart. I have a whole stack of letters, art, pictures and, most recently, a textbook on electromagnetic theory that would not have been written without my

intervention. They mean more to me than an ersatz online post. Every Valentine’s Day, I receive a bottle of champagne to commemorate the day I operated on a special patient. What do I do with these? Cheapen them by sending them out on Snapchat? Or is that the one that disappears? I know I will eventually need to manage my online presence, not only for my business but to set a good example for my son. He is no longer buying the whole do-as-I-say-not-as-I-do line with my swearing. I must do better with the Internet. I just find the whole thing a little smarmy (sorry, Florida). A physician’s reputation will soon be directly proportional to the skill of his or her public relations directors and not to actual ability or caring attitude. Personally, when I want to find a new physician for a family member, I don’t turn to the Internet; I call the operating room nurses or the anesthesiologist to find out who does the best hip, for example. The primary care doctors can tell me who is the nicest surgeon to their patients and who sends the most detailed letters back to them, but I want the person who does the best job. The real information on quality is not always measurable or available to the public. Perception is reality and the Internet offers doctors many opportunities to improve their reputation and increase their patient load. It is a new world, and eventually Boston will be plastered with billboards of physicians trolling for business with a medical malpractice firm’s billboard right behind each one. Rating websites will be populated by favorable reviews, whether real or not. I’m going to start by buying a “best doctor" plaque for my office. Maybe I can get a deal if I backorder a dozen. For those of you who have managed the Internet successfully, or who read those affirmations, don’t bother writing back to tell me to stop whining and get with the times because you won’t find me. I am changing my contact information to NotClaireCronin.com. —Dr. Cronin is a general and vascular surgeon in — Newton, Mass.

GSN Bulletin Board

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Be Prepared for Electronic Record Breaches, Experts Warn B Y D AVID W ILD

f you have not yet endured an electronic patient data theft, you most likely will experience one before too long, experts warn. They say the transition to electronic health records (EHRs) has not been accompanied by adequate safeguards, and they are calling on physicians to do more to protect patient data. â&#x20AC;&#x153;Health care systems will be seeing

large-scale hacks of the type weâ&#x20AC;&#x2122;ve seen with retailers like Target,â&#x20AC;? said Katherine Downing, MA, director of Health Information Management Practice Excellence at the American Health Information Management Association, in Chicago. Ms. Downing noted that the FBI recently warned health care providers about the likelihood of such cyberattacks (http://reut.rs/1w9sZSL). Health data are much more valuable than data from other industries because

EHRs typically contain far more information, said Ms. Downing. Indeed, a single complete EHR profile can include information on health insurance, prescription drugs, financial details and Social Security numbers. That wellspring of information means a record can sell for $50 on the black market, while a Social Security number fetches only $1 (http://bit. ly/1pS2nzz). Thieves use that information to do everything from accessing medical care,

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Part 2: Ongoing Challenges and Opportunities Case Study Dennis is a 68-year-old man undergoing open abdominal surgery (colectomy). Current Symptoms Â&#x2021; Dyspnea Vital Signs Â&#x2021; Height: 175 cm Â&#x2021; Weight: 85 kg 6LJQLÂżFDQW 0HGLFDO +LVWRU\ Â&#x2021; Hypertension Â&#x2021; Congestive heart failure Â&#x2021; Obstructive sleep apnea &XUUHQW 0HGLFDWLRQV Â&#x2021; Metoprolol 100 mg PO Â&#x2021; Ramipril 2.5 mg PO Laboratory Results Â&#x2021; Apnea hypopnea index: 26/h Â&#x2021; Left ventricular ejection fraction: 30%-35% Anesthesia is induced with sufentanil, propofol, and 0.6 mg/ kg rocuronium based on total body weight and maintained ZLWK GHVĂ&#x20AC;XUDQH LQ DLU R[\JHQ DQG VXIHQWDQLO 6XUJLFDO FRQGLWLRQV DUH GLIÂżFXOW ZLWK D ODFN RI DEGRPLQDO ZDOO PXVFOH relaxation and poor paralysis. An extra dose of rocuronium is administered for deeper neuromuscular block (NMB), and fewer than 2 train-of-four (TOF) responses are noted.

Global Education Group and Applied Clinical Education are pleased to introduce part 2 of a 3-part interactive CME series featuring challenging cases in NMB. Each activity presents a clinical scenario that you face in your daily practice. After reading the introduction to the case, consider the challenge questions, and then visit ZZZ &0(=RQH FRP QPE WR ÂżQG out how your answers stack up against those of our multidisciplinary faculty panel. Access the activities on your desktop, laptop, or tablet to explore the issues surrounding safe, effective, NMB reversal via a unique multimedia learning experience and earn 1.0 AMA PRA Category 1 Credit.â&#x201E;˘ Complete the whole series and earn a total of 3.0 AMA PRA Category 1 Credits.â&#x201E;˘ 7KLV DFWLYLW\ÂśV GLVWLQJXLVKHG IDFXOW\

6RULQ - %UXOO 0' Professor of Anesthesiology Mayo Clinic College of Medicine Jacksonville, Florida

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Challenge Questions 1. What would you do if, at the end of the case, the TOF count is zero? 2. What would you do if, at the end of the case, the TOF count is 2?

Medical Director, Manager New Medical Center Nancy, France

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obtaining prescription drugs and, according to a recent report, filing false income tax returns that, in one case, resulted in more than $175,000 in tax refunds being issued to the thief (http://bit. ly/1zeGD9E). The list of breaches is long and continues to grow: According to the Identity Theft Resource Center, there were 247 reported breaches of health care data as of September 2014, and more than 7 million patient records were compromised as a result (http://bit.ly/10xhSr4). The largest health care breach in 2014 resulted in 4.5 million patient EHRs being compromised. That breach occurred at Community Health Systems, which is the second-largest for-profit hospital chain in the United States. Although large breaches like this make the news, the Identity Theft Resource Centerâ&#x20AC;&#x2122;s website indicates that many breaches occur at smaller health care settings.

Despite Ongoing Breaches, Feds Tout Regulatory Measures As the incidence of EHR breaches continues relatively unabated (the number dropped slightly in 2014 compared with 2013), the Department of Health and Human Services (HHS) claims federal measures addressing the problem have had positive effects. In its most recent breach notification report, the HHS pointed to the effect of Section 13402 of the Health Information Technology for Economic and Clinical Health (HITECH) Act, which requires entities covered under the HIPAA to notify affected individuals, the HHS, and in some cases, the media, of health care data breaches. HITECH also requires business associates such as data analysis companies to report breaches of their systems to covered entities. â&#x20AC;&#x153;The breach notification requirements are achieving their twin objectives of increasing public transparency in cases of breach and increasing accountability of covered entities and business associates,â&#x20AC;? the report concluded. â&#x20AC;&#x153;At the same time, more entities are taking remedial action to provide relief and mitigation to individuals and to secure their data and prevent breaches from occurring in the future.â&#x20AC;? In an email to General Surgery News, a representative from the Office of Civil Rights (OCR) said no additional regulatory steps were currently being taken by the HHS to reduce the risk for health care data breaches. Matthew Hollingsworth, the founder and president of Dayton, Ohio-based ChangeMed, a company that provides services, support and advice related to health care information technology (IT), said that an HHS requirement that

In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / DECEMBER 2014

â&#x20AC;&#x2DC;The potential for fines when you do have a data breach is significantly lower when you can show youâ&#x20AC;&#x2122;ve done all you can to prevent a breach.â&#x20AC;&#x2122; â&#x20AC;&#x201D;Matthew Hollingsworth HIPAA-covered entities conduct security risk assessments of their EHR systems provides a big incentive for providers to tighten EHR security. Failure to perform such an assessment proved costly for NewYork-Presbyterian (NYP) Hospital and Columbia University, both of which paid the OCR $4.8 million after electronic patient health information (ePHI) about 6,800 individuals, including data about patient status, vital signs, medications and lab results, was exposed in 2010 (http://1.usa.gov/1wDVMgf ). An OCR investigation concluded that neither organization had conducted â&#x20AC;&#x153;an accurate and thorough risk analysis that identified all systems that access NYP ePHI.â&#x20AC;?20 This case underscores the importance of taking steps to institute preventive measures. â&#x20AC;&#x153;The potential for fines when you do have a data breach is significantly lower when you can show youâ&#x20AC;&#x2122;ve done all you can to prevent a breach,â&#x20AC;? emphasized Mr. Hollingsworth.

Things You Can Do Right Now Smaller practices that do not have staff with specialized IT security knowledge might find it daunting to consider the challenge of securing data, given that large organizations like NYP and Columbia University have fallen victim to breaches. â&#x20AC;&#x153;However, there are steps even small practices can take to tighten the security of their EHRs,â&#x20AC;? Mr. Hollingsworth said. For example, the HHS has an online risk assessment tool that any office staff can use (http://bit.ly/1wDW6f5). Changing passwords often, ensuring there are sufficient firewall protections, using highly encrypted data and installing up-to-date antivirus software can help as well, Mr. Hollingsworth said. â&#x20AC;&#x153;Although a determined hacker can break into almost any system, these steps might encourage them to move on to a less secure system,â&#x20AC;? he said.

Many Still Email Patient Information Emailing unencrypted patient data also places that information at risk for falling into the wrong hands, said health IT expert Cary Presant, MD, a professor of clinical medicine at the University of Southern California Keck School of Medicine and a staff oncologist at City of Hope Hospital, both in Los Angeles.

â&#x20AC;&#x153;HIPAA rules prohibiting the use of non-encrypted digital communications that contain patient health information are not being widely implemented,â&#x20AC;? Dr. Presant said. For patients, email is an

easy mode of communication; physicians may succumb to patient pressure. However, Dr. Presant urged physicians to educate patients about the associated risk for identity theft. Dr. Presant also urged both clinicians and office staff to take advantage of educational opportunities offered by organizations such as the American Society of Clinical Oncology. Ms. Downing echoed that recommendation. â&#x20AC;&#x153;Make sure you and your staff are educated and trained as to how EHRs can be used in the most secure way,â&#x20AC;? she said. â&#x20AC;&#x153;Human error is one way

for breaches to occur.â&#x20AC;? Ms. Downing also said that granting EHR access only to staff members who truly need such access is a preventive measure practices can take. â&#x20AC;&#x153;And when youâ&#x20AC;&#x2122;re auditing access [to EHRs], make sure you document the process, and do the same with any other security-related policies,â&#x20AC;? Ms. Downing said. â&#x20AC;&#x153;That documentation will reduce your liability in case there is a breach.â&#x20AC;? For additional tips on how to protect your patientsâ&#x20AC;&#x2122; records, visit www.hhs. gov/ocr/privacy/hipaa/understanding/ training.

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Part 1: Framing the Issues Case Study Harold is a 74-year-old man undergoing a video-assisted right upper lobectomy for stage I non-small cell lung cancer. Current Symptoms Â&#x2021; Dyspnea Â&#x2021; Coughing with hemoptysis Â&#x2021; Chest pain Vital Signs Â&#x2021; Height: 177.8 cm (70â&#x20AC;?) Â&#x2021; Weight: 65 kg (143 lb) 6LJQLÂżFDQW 0HGLFDO +LVWRU\ Â&#x2021; Hypertension Â&#x2021; Chronic obstructive pulmonary disease (moderate) &XUUHQW 0HGLFDWLRQV Â&#x2021; Metoprolol succinate ER 50 mg/d Â&#x2021; Tiotropium bromide inhalation powder Laboratory Results Â&#x2021; 2-cm lesion in right upper lobe revealed on chest computed tomography (CT) scan; PDOLJQDQF\ FRQÂżUPHG ZLWK QHHGOH ELRSV\ Â&#x2021; No abnormal bronchopulmonary or mediastinal lymph nodes; brain CT, isotopic bone scan, abdominal ultrasonography negative for distant metastases Â&#x2021; )RUFHG H[SLUDWRU\ YROXPH LQ WKH ÂżUVW second: 43.6% of predicted value (1.44 L) Â&#x2021; Carbon monoxide diffusing capacity: 71.7% of predicted values (20.19 mL/min/mmHg) Â&#x2021; Cardiac ultrasonography: normal pulmonary artery pressure (22 mm Hg) At induction, Harold receives propofol 1.5 mg/kg and rocuronium 0.6 mg/kg. During the procedure, movement of the diaphragm interferes with surgery. This activity is jointly provided by Global Education Group and Applied Clinical Education. Supported by an educational grant from Merck.

Applied Clinical Education is pleased to introduce a new interactive 3-part CME series featuring challenging cases in neuromuscular blockade. Each activity will present a clinical scenario that you face in your daily practice. After reading the introduction to the case, consider the challenge questions, and then visit ZZZ &0(=RQH FRP QPE WR ÂżQG RXW KRZ \RXU DQVZHUV stack up against those of our multidisciplinary faculty panel. Access the activities on your desktop, laptop, or tablet to explore the issues surrounding safe, effective, neuromuscular blockade and reversal via a unique multimedia learning experience and earn 1.0 AMA PRA Category 1 Credit.â&#x201E;˘ Participate in the coming months as well to complete the whole series and earn a total of 3.0 AMA PRA Category 1 Credits.â&#x201E;˘ 7KLV DFWLYLW\ÂśV GLVWLQJXLVKHG IDFXOW\ -RQ *RXOG 0' *OHQQ 6 0XUSK\ 0' Chief, Division of General Surgery Alonzo P. Walker Chair in Surgery Associate Professor of Surgery Medical College of Wisconsin Senior Medical Director of Clinical Affairs Froedtert Hospital Milwaukee, Wisconsin

Clinical Professor, Anesthesiology University of Chicago Pritzker School of Medicine Director Cardiac Anesthesia and Clinical Research NorthShore University HealthSystem Evanston, Illinois

Challenge Questions 1. What would you do next? 2. What potential postoperative risks does this patient face?

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*SurgiMend does not trigger a detrimental foreign-body inﬂammatory response that would lead to rapid degradation or encapsulation. Photograph displays cellular repopulation and revascularization of 3 mm thick SurgiMend in a small animal intra-abdominal implant model. References: 1. Clemens MW, Selber JC, Liu J, et al. Bovine versus porcine acellular dermal matrix for complex abdominal wall reconstruction. Plast. Reconstr. Surg. 2013;131(1):71–9. 2. Adelman DM, Selber JC, Butler CE. Bovine versus porcine acellular dermal matrix: a comparison of mechanical properties. Plast. Reconstr. Surg. Glob. Open. 2014. 3. Deeken CR, Eliason BJ, Pichert MD, et al. Differentiation of biologic scaffold materials through physicomechanical, thermal, and enzymatic degradation techniques. Ann. Surg. 2012. 4. Adelman DM. Radiographic evaluation of biologic mesh repair in ventral abdominal herniorrhaphy. In: Proceedings of the American College of Surgeons. Washington DC; 2013. 5. Booth JH, Garvey PB, Baumann DP, et al. Primary fascial closure with mesh reinforcement is superior to bridged mesh repair for abdominal wall reconstruction. J. Am. Coll. Surg. 2013. 6. Cornwell KG, Greenburg AG, James KS. A generative tissue fabricated with SurgiMend has a mesothelial lining limiting adhesion formation in a model of large ventral hernia repair. In: American Hernia Society; 2010. © 2014 TEI Biosciences Inc. All rights reserved. SurgiMend is a registered trademark of TEI Biosciences Inc.