May 2015

Page 1

CONVENTION ISSUE:

American Society of Colon and Rectal Surgeons

GENERALSURGERYNEWS.COM

May 2015 • Volume 42 • Number 5

The Independent Monthly Newspaper for the General Surgeon

Opinion

New Studies Reveal Shift in Understanding of Sepsis

You Are as Smart As Your Patients

Return to Hospital After Sepsis ‘Cure’ Likely; New Approach Needed

B Y I BRAHIM E ID , MD

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s surgeons, we have always lived in the selfcontained medical community bubble where our image depends predominantly on our personal and social relationships with our peers and referring physicians, and where our hospital status emanates from the volume of procedures we command, assuming a reasonable safety profile. Patients have always been handed down our recommendations as the only path to better health. This physician-centric world belongs to the past, and the future one being charted in front of our eyes is governed by new rules that use words like “patient experience,” “engagement,” “patient-centered” and “value-based.” This new world, outlined by the language of health care reform, was born out of the exorbitant cost of the status quo, a cost that was not matched with the quality that other less expensive systems provided. The 2009 white paper by Thomson Reuters’s Robert Kelley, outlining where

see page 16

B Y M ONICA J. S MITH

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year ago, a study published in the Journal of the American Medical Association ((JAMA A) reported that more patients than ever are surviving after treatment for severe sepsis (2014;311:1295-1297). But now, research shows that the finding only tells one part of the story. A spate of recent studies shows the immense burden of sepsis survivorship in the United States. Four studies and two editorials revealed that people who are treated for and survive severe sepsis and septic shock are frequently rehospitalized within a few months, often for potentially preventable conditions,

and credited it with helping prepare him for a broad surgical practice. “I saw TTP as a great opportunity for a number of reasons. The first, and perhaps most important for me in my residency, was to plan for a gradual increase in autonomy from resident to completely independent practice,” Dr. Kellogg said.

CHATTANOOGA, TENN.—Routine torso computed tomography (CT) imaging is a significant g source of patient radiation, cost and delays to treatment. New research suggests that a thorough history and physical exam in the trauma bay can allow the physician to order CT imaging selectively in patients with lowimpact blunt trauma. “Our aim was to demonstrate if it was safe and feasible to limit torso imaging of these patients, especially those who fall from standing, toileting or sleeping,” said Kedar Lavingia, MD, a postgraduate year 3 resident at Eastern Virginia Medical School in Norfolk. To do so, Dr. Lavingia and his colleagues conducted a retrospective chart review of 156 patients admitted to the trauma bay between January 2013 and April 2014, eliminating nine who met the exclusion criteria of undergoing intubation or having a Glasgow Coma Score (GCS) less than 13. Dr. Lavingia reported the group’s findings at the Southeastern Surgical Congress. The investigators defined significant thoracic injury as hemothorax (HTX), pneumothorax (PTX) or more than three rib fractures. Significant abdominal injuries were defined as solid organ

see SURGICAL TRAINING page 23

see CT SCANNING page 27

see SEPSIS page 26

Lacking Confidence in Training? Program Provides Bridge to Practice B Y M ONICA J. S MITH CHATTANOOGA, TENN.—As one of the first participants in the American College of Surgeons (ACS) Transition to Practice (TTP) Program, Benjamin E. Kellogg, MD, said the program eased his transition from resident to a practicing general surgeon,

INSIDE In the News

In the News

Opinion

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Doing the Math: Can Robotic Surgery Be Cost-Effective for General Surgery? Part 1 of 2

Unnecessary CTs Avoided With Thorough History, Exam

B Y C HRISTINA F RANGOU

see PATIENT-CENTERED page 28

Perioperative Goal-Directed Therapy: Optimizing Fluid Management and Reducing Postoperative Complications

Selective Scanning Warranted for LowImpact Trauma

Nearly 500,000 Americans Suffered From C. Difficile e Infections In a Single Year

Oncologist argues that breast ultrasound-guided biopsies should be done the same day as imaging whenever possible

Question the norm. Do the tools you need exist today?

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GSN Editorial

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / MAY 2015

Autonomy and Beneficence as Quality Outcomes Frederick L. Greene, MD, FACS Clinical Professor of Surgery UNC School of Medicine Chapel Hill, North Carolina

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ost of you who are loyal readers of General Surgery News, no matter what your vintage, have become aware of the magical significance of the “30-day rule” that has been used in reporting surgical outcomes for postoperative morbidity and mortality. This “iconic” timeframe has assumed additional meanings in reference to benchmarks for postoperative hospital readmission; outlier timeframes to expect a history and physical examination documented in the hospital record (not more than 30 days preoperatively); the public reporting of complications and deaths after surgical procedures; the reporting of outcomes in surgical peer-reviewed literature; and, most importantly, the long-used timing rule for presenting cases at our morbidity and mortality conferences. In the modern era of surgical care, in which a patient can be supported for longer periods of time and whose complications may not manifest until many weeks after major surgery, the 30-day rule may have little meaning and may actually give

a false sense of outcomes in surgical treatment. If this benchmark continues to be perpetuated, patients who expire more than 30 days postoperatively or remain more than 30 days in the ICU on ventilators or treated with other forms of supportive care will be underreported. Many of you will agree that this is the case! This discussion is not new, but seems to have garnered little traction. Even robust programs, such as the National Surgical Quality Improvement Program (NSQIP) under the auspices of the American College of Surgeons, continues to use the 30-day postoperative risk-adjusted data as benchmarks for collection and reporting hospital comparisons using NSQIP collected outcomes. I believe the overall NSQIP strategy is extremely important, and I pushed hard to introduce it in my own institution, but we continue to be imbued with the notion that 30 days is the ultimate benchmark when, in fact, 60- and 90-day outcomes may give a better picture of the modern surgical landscape. There may be other, more important reasons to eschew our traditional 30-day criterion. Outcome measures are important for benchmarking care and improving quality, but public reporting of 30-day mortality statistics may lead to unintended

harmful consequences, especially for the most vulnerable patients. The biggest challenges are deciding to operate on high-risk patients and honoring patient preferences about the use of postoperative life-supporting treatments. If we continue to embrace a 30-day benchmark for reporting postoperative outcomes, the unintended consequence may be to encourage more surgeons not to operate on patients who have a significantly higher likelihood of not surviving past 30 days. This is especially significant when individual surgeon outcomes are used in decisions regarding continuation of hospital credentialing and privileging. In addition, with our continued reverence for 30-day benchmarking, the challenge is to do everything possible to ensure that patients survive past this milestone. Our decisions regarding continuation of patient care should always be based on beneficence and patient autonomy and not driven by a desire to have a patient survive beyond a meaningless yardstick. This subject served as an important discussion for a panel at the 2014 Clinical Congress of the American College of Surgeons (“Ethical Issues Associated with Publicly Reporting 30-day Mortality Statistics”) and has been the focus

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of recent essays (Beyond 30-day Mortality: Aligning Surgical Quality with Outcomes that Patients Value; JAMA Surgery 2014;149:631-632). The authors state that “use of this single metric (30-day reporting) unintentionally fails to accommodate patients who might benefit from palliative surgery, or patients who would prefer death to prolonged postoperative treatment in the intensive care unit or long-term chronic care after a major complication.” What we need is to institute quality metrics that highlight “beneficence” and “autonomy,” but are not merely based on indicators of time, which has little relevance in the benchmarking of modern surgical care. Implementation of alternative quality metrics would protect both patient decision making and the surgeons who must always be advocates for their patients’ quality of life. This dialogue must be initiated and perpetuated by our leading surgical organizations. Perhaps most importantly, the leadership of our local academic and community surgical services could be the driving forces in discussing the arcane role of the 30-day metric and work to create indicators that will satisfy the current roles of patients and surgeons alike.

Paul Bufano Associate Editor pbufano@mcmahonmed.com James Prudden Group Editorial Director Robin B. Weisberg Manager, Editorial Services Elizabeth Zhong Associate Copy Chief

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Mission Statement It is the mission of General Surgery Newss to be an independent and reliable source of news and analysis about the current state of surgery. It strives to provide a venue for discussion and opinions, from all viewpoints, on the issues most important to surgeons.

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Change of Address Procedure All U.S. general surgeons, colorectal surgeons, vascular surgeons, surgical oncologists and trauma/critical care surgeons should receive General Surgery News free of charge. If you are changing your address or name, you must notify the AMA at (800) 262-3211 or the AOA (if appropriate) at (800) 621-1773 to continue receiving GSN. You need not be a member; however, they maintain the ultimate source of our mailing addresses. If you are not a general surgeon or other specialist listed above and would like to subscribe, please send a check payable to General Surgery News. Please allow 8-12 weeks for the first issue. Subscription: $70 per year (outside U.S.A., $90). Single copies, $7 (outside U.S.A., $10). Send checks and queries to: Circulation Coordinator, General Surgery News, 545 West 45th Street, 8th Floor, New York, NY 10036. Fax: (212) 664-1242.

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GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / MAY 2015

Part 1 off 2

Doing the Math: Can the Robot Be Cost-Effective for General Surgery? Seeking Real Numbers To Find in What Scenarios the Robot Can Make Sense Financially B Y V ICTORIA S TERN

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ebate over the value of robotic surgery is far from resolved. General surgeons tend to agree that the current robotic platform delivers what it promises—enhanced visualization, dexterity and control on the part of surgeon—but that these perks come at a high financial investment. Given the costs, it is unclear whether robotic surgery can become costefficient and thus whether the surgical community can justify its use. “There are a lot of strong opinions when it comes to robotic surgery,” said Julio Garcia Aguilar, MD, PhD, chief of colorectal service and Benno C. Schmidt Chair in Surgical Oncology at Memorial Sloan-Kettering Cancer Center in New York City, and a leader in robotic colorectal surgery. “Some surgeons are strongly in favor of robotics, and others are completely against it because there is insufficient evidence to recommend it. I can see both sides of the argument.” This article will attempt to uncover whether robotic surgery can become costeffective. A cost-effectiveness analysis of robotic surgery would incorporate direct expenses, such as capital, maintenance and instrument costs as well as indirect costs, such as complications, hospital length of stay (LOS) and readmissions. Regarding direct costs, a da Vinci Surgical System, developed and sold by Intuitive Surgical, starts at about $600,000 but can increase to as much as $2.5 million, depending on the model and addons. Institutions are then faced with yearly maintenance fees that range from $100,000 to $170,000, as well as robotspecific instruments and accessories, which can add $700 to $3,200 to a procedure. Instruments alone tend to cost $2,300 for a 10-use device. The lifetime of a da Vinci robot is a maximum of seven years. Studies attempting to estimate the short-term costs associated with robotic procedures have largely shown that hospitals spend between $1,000 and $4,000 more per robotic case compared with laparoscopic or open procedures, in addition to the cost to purchase and maintain the robot. A 2010 New England Journal of Medicinee report estimated that if robotassisted operations replaced conventional procedures, an additional $2.5 billion would be spent in annual health care costs (2010;363:701-704).

Even with these cost estimates, the use of the da Vinci Surgical System has skyrocketed in the 15 years since the FDA approved its use. In 2000, about 1,000 robotic operations were performed worldwide, but by the end of 2014, that number had increased to 570,000, according to Intuitive Surgical’s 2015 10-K report. The majority of procedures performed in 2014 were robot-assisted hysterectomies (approximately 203,000 procedures) and prostatectomies (125,000 procedures). As of Dec. 31, 2014, 3,266 systems were being used worldwide, 2,223 of which were in the United States. The report also disclosed that total revenue for Intuitive Surgical in 2014 was $2.1 billioon, 70% of which ($1.47 billion) was frrom purchases in the United States. “Robotic surgery seems likee a losing financial proposition,” said d Patricia Sylla, MD, FACS, FASC CRS S, S,

lot of costs and interest going into robotics but it wasn’t clear whether there was value to it,” recalled Dr. Loftus, a general surgeon who specialized in laparoscopic surgery, not robotics, before taking his position at Banner Health. “I was a skeptic about robotic surgery, but over time, as I’ve looked at the numbers as an administrator, I’ve started to change my tune. I’m becoming more of a believer, a reserved believer.” Dr. Loftus has spent the past two years studying costs and outcomes associated with robotic surgery in the Banner Health network, which has 28 hospitals and 20 robots.

‘I was a skeptic about robotic surgery, but over time, as I’ve looked at the numbers as an administrator, I’ve started to change my tune. I’m becoming more of a believer, a reserved believer.’ —Terry Loftus, MD a colorectal surgeon at Mou unt Sinai Hospital in New York City. “T Theere’s never been a frank talk about the costs of robotic surgery from an adminisstrattive standpoint, and as surgeons, it’ss haard to tell how we can generate money foor the hospital given that laparoscopiic an nd robotic procedures are reimbursed equaally.” For the majority of cases, Peeter Dunn, MD, director of perioperatiive services at Massachusetts General Hosspitaal, Boston, has found that robotic surrgeryy is costly without significant benefit. “T There is no scientific data to show robootic surgery is better for patients,” said Dr. r Dunn Dunn. “The bulk of the evidence in favor of robotic surgery remains anecdotal, and I have found that other minimally invasive techniques are less expensive and have similar or superior clinical outcomes compared to robotic surgery.” Some hospital administrators, however, have uncovered ways to minimize costs associated with robotic surgery and, in some instances, make it cost-effective. When Terry Loftus, MD, chief medical director of Surgical Services and Clinical Resources for Banner Health, Phoenix, started his role, the chief financial officer (CFO) asked him to gain a better understanding of robotic surgery. “The CFO said that we were seeing a

“I can’t ignore costs in my role, particularly as they apply to new purchases,” Dr. Loftus said. “Every time we decide about the capital purchase of a robot, we have to give a lot of attention to whether it will be good value for the institution or not.” What Dr. Loftus has come to realize is that a hospital can improve patient care and generate a decent margin from robotic surgery if it considers the robotic system as a program, not a piece of technology. “You have to create a sense of organization around robotic surgery to understand the circumstances under which it works best and avoid unnecessary costs and wasteful use,” Dr. Loftus said. “That is probably a major distinguishing factor between hospitals that find the robot a cost-effective investment and those that don’t.”

Minimizing Costs of Robotic Systems The following sections will describe several scenarios in which hospitals and surgeons can reduce costs associated with robotic surgery, assuming an institution

has decided to invest in a robot.

Judicious Use of Instruments One key to making robotic surgery more cost-efficient is simply minimizing the number of tools surgeons use. “When I started analyzing robotic surgery, one of the first things I noticed was the range of supply costs,” Dr. Loftus said. “We found that the costs of instruments for robotic cases varied threefold. The supply costs were three times greater for the highest-cost case compared with the lowest-cost case, but there was no difference in quality. In other words, there was no correlation between supply

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costs and surgical quality.” Dr. Loftus recalled that Randy Fagin, MD, chief administrative officer at Texas Institute for Robotic Surgery in Austin, observed an identical pattern across the HCA Healthcare network, which has 152 robots. “The information looked the same in two completely different health systems,” Dr. Loftus said. Although minimizing the number of instruments used in robotic surgery is a sound way of keeping costs down, this argument is not exclusive to robotic surgery. Surgeons and administrators can apply this logic to laparoscopic and open see ROBOT COSTS page 6

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GENERALSURGERYNEWS.COM G SU G S CO / GENERAL G SURGERY SU G NEWS S / MAY 2015 0 5

ROBOT COSTS jcontinued from page 4

surgery, also making these approoaches less costly. Several years earlier, Dr. Loftu us had noticed the same variations in thee costs of laparoscopic instruments. “Essentially, we’ve allowed bad habits from the laparoscopic days to roll over into robotics,” Dr. Loftus said. “W We may have been able to get away with these costs in laparoscopic surgery, but roobotic equipment tends to be more expeensive. When you carry over the same habits into robotics, you’re increasing thaat cost problem by a higher magnitude.”

Surgeon Experience Just as the key to real estate is “location, location, location,” the key to robotic surgery is “exposure, exposure, exposure,” Dr. Loftus said. Exposure can refer to how much experience a surgeon has with a specific type of operation. “We found that more experience with a robotic approach leads to better outcomes,” Dr. Loftus said. Between October 2013 and September 2014, Dr. Loftus and his colleagues compared the outcomes of robotic surgeons in 10 hospitals based on their volume of cases. Dr. Loftus observed significant differences in complications, LOS, readmissions and total costs between the most experienced robotic surgeons who averaged about 80 cases per year and least experienced robotic surgeons who averaged closer to five cases per year. Low-volume surgeons had a 36.2% greater likelihood of complications, 11.1% greater LOS and 65.6% greater readmission rate, and incurred 20.4% more in costs compared with high-volume surgeons. Conor P. Delaney, MD, PhD, chief of colorectal surgery and vice-chair of surgery at the University Hospitals Case Medical Center in Cleveland, and his colleagues found similar trends when comparing outcomes of robotic colorectal surgery from low- and high-volume providers ((J Am Coll Surgg 2013;217:10639.e1). After evaluating 1,428 robotic colorectal cases across 123 hospitals and 411 surgeons, Dr. Delaney and his colleagues found that lower-volume surgeons, who performed about 95% of procedures, had significantly more complications, longer LOS and higher costs of care. “If a surgeon just dabbles on the robot, he or she is probably getting worse outcomes at much higher costs,” Dr. Loftus said. “That is one direct reason why costs are so elevated with robotic surgery. When evaluating a robotic program, surgeon experience is a key factor driving costs.” Dr. Aguilar agreed that surgeon

experience is critically important for improving outcomes in minimally invasive and open procedures. “It’s been shown in many studies that the surgeon is a significant factor,” he said. “Surgeons do not have the same level of skill across the board in robotics and that will impact outcomes.”

‘Best-case scenario is that laparoscopic and robotic colon surgery is the same in terms of outcomes, but [the robotic] comes at higher costs.’ —Conor P. Delaney, MD, PhD

Industry Competition Currently, Intuitive Surgical is the only robotics game in town. Without competition in the robotic market, the prices for the technology have largely stayed stagnant. “In the absence of competition, the capital, maintenance and operational costs will remain high and will be an appropriate barrier to its adoption,” said David Jaques, MD, vice president of surgical services at Barnes-Jewish Hospital and professor of surgery at Washington University, both in St. Louis. Until there is competition to lower the initial costs of the system, perhaps the easiest way to save on the da Vinci system is to purchase an older model or the new Si, which is about half the capital investment of the newest Xi model that can cost more than $2 million. “Now that the new Xi model is out, the costs of the older Si model have gone down considerably,” Dr. Loftus said. “The Xi is advantageous for the more technically demanding cases, but most cases can be done on a lower-cost robot. Hospitals can reserve the Xi for the complex inpatient cases.”

Defining Appropriate Use Being selective about which cases are performed robotically is also important for keeping costs down. “When I made a list of all cases done robotically in the Banner network, I saw some things I couldn’t believe,” Dr. Loftus said. “Some physicians were doing a range of procedures, such as biopsies and diagnostic laparoscopies, using the robot, which is clearly an inappropriate use of the technology. Certain cases should not be done robotically because there is no evidence to support it and it’s not

In one study from 10 hospitals, low-volume robotic surgeons had ... $ $ • 36.2% greater likelihood of complications $ greater length of stay in the hospital • 11.1% • 65.6% greater readmission rate $• 20.4% more in costs ... than high-volume robotic surgeons using the robot.

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cost-effective.” After making this observation, Dr. Loftus helped set up a tiered system at one hospital, which spread across the Banner network. The tiered system provides a graded evaluation of robotic cases where tier 1 cases show evidence of strong clinical and financial effectiveness and tier 4 cases have no evidence. As an example, in gynecology, tier 4 procedures include diagnostic laparoscopy, simple biopsy, ectopic pregnancy, ovarian cystectomy and tubal ligation, whereas tier 1 cases include robotic hysterectomy for endometrial or cervical carcinoma. The system, implemented in January 2014, required surgeons to request institutional approval before performing tier 4 cases robotically. In 2012, 12.6% of the general surgery cases scheduled throughout Banner Health hospitals would have been considered tier 4, but by the end of 2014, only 0.6% of cases were tier 4. In other words, before implementing the tiered system, about 126 of every 1,000 cases would be tier 4, but after, only six cases were tier 4. According to Dr. Loftus, each tier 4 case costs an additional $1,400 to $2,200 compared with its laparoscopic counterpart. Thus, the clinical practice eliminated 120 tier 4 cases for a potential cost savings between $168,000 and $264,000. Because last year, Banner Health performed about 3,700 robotic cases, it saved between $621,600 and $976,800. “Once we started to reduce those tier 4 cases, we eliminated so much waste and excess costs in the system,” Dr. Loftus said. “It’s great that some surgeons are enthusiastic about the technology, but the robot is not designed for everything.” For instance, with hysterectomies, robotic surgery may only be worthwhile in very specific cases. In 2013, James T. Breeden, MD, president of the American College of Obstetricians and Gynecologists issued a cautionary statement asserting that “while there may be some advantages to the use of robotics in complex hysterectomies, especially for cancer operations that require extensive surgery and removal of lymph nodes, studies

have shown that adding this expensive technology for routine surgical care does not improve patient outcomes.” Similarly, according to Dr. Delaney, robotic colorectal surgery would fall in the low to no evidence category. When comparing laparoscopic and robotassisted colorectal surgery in a large national inpatient database analysis, Dr. Delaney and his colleagues found that LOS and complications were no different, but that robotic cases took longer (39 minutes) and were more costly ($5,272 more considering variable costs and $4,432 more considering fixed costs; Surg Endoscc 2014;28:212-221). “Best-case scenario is that laparoscopic and robotic colon surgery is the same in terms of outcomes, but [the robotic] comes at higher costs,” said Dr. Delaney, also the Jeffrey Ponsky Professor of Surgical Education at Case Western Reserve University, in Cleveland. “There is continued discussion about possible benefits of the robot in rectal surgery, but we need more data to show whether this benefit is worth the costs associated with the technology.” According to Akash Bijlani, director of Healthcare Economics and Market Access at Intuitive Surgical, the potential for robotic colorectal surgery may play out when moving from open to minimally invasive colorectal procedures, considering that about 50% to 70% of colectomies in the United States are performed open. But this story continues to evolve. Still, Dr. Jaques pointed out, “The failure to spend unwisely should not be thought of as a savings. Rather, it is a value-driven decision that avoids cost.” In other words, for hospitals that have already invested in a robot, effectively managing how the robot is used becomes critical for minimizing extra costs and ensuring the best patient care. Drs. Aguilar, Delaney, Dunn, Jaques, Loftus and Sylla reported no conflicts of interest. Part 2 of this series will be published next month and will deal with specific ways that the robot could lead to cost savings and how the robot affects a hospital’s bottom line.

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GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / MAY 2015

Experts Discuss Managing Hereditary Colorectal Cancer Syndromes Thorough History, Genetic Testing And Enhanced Screening Can Forestall Advance of Disease B Y C HASE D OYLE SAN FRANCISCO—Close screening and follow-up of patients with genetic predispositions to colorectal cancer syndromes have major implications for the prevention and treatment of these syndromes, according to findings presented at the 2015 Gastrointestinal Cancers Symposium. “Careful follow-up of family members when hereditary colorectal cancer syndromes are found makes the diagnosis cost-effective and can dramatically alter the natural history of the disease,” said C. Richard Boland, MD, chief of gastroenterology at Baylor University Medical Center, in Dallas. “With colonoscopies and some occasional extra surgery, [clinicians] can turn Lynch syndrome into a fairly ‘boring’ disease— without the big surprise of cancer.” Dr. Boland reported that the first step in evaluating familial clusters is determining whether it is a colonic or intestinal polyposis syndrome or one of the nonpolyposis syndromes. However,

2,843 codons, Dr. Boland said, “Such a big target is an invitation for genetic trouble.” FAP is a systemic disease, with an associated likelihood of periampullary cancer somewhere between 5% and 8%. Patients can develop duodenal adenomas, which are true neoplasms and lead to cancer; fundic gland polyps, which are not neoplasms although they look like they are to many pathologists; desmoid tumors; as well as other forms of cancer. MAP is caused by mutations in MutYH, H a base-excision repair gene (Figure). “Mutations are usually missense,” Dr. Boland elaborated, “and the mutations are dominated by founder mutations.” According to Dr. Boland, the two most common mutations in the MutYH H gene for whites are a very inactive allele and a hypomorphic allele. The interaction between the two accounts for the heterogeneity of the syndrome. “A typical diagnostic strategy [for Europeans] is to look for these two mutations first,” he explained, “and if one of them is found, then … sequence the whole gene looking for the other. However, if it’s not a European, then you probably have to ask for the whole gene to be sequenced,” he added, noting that “with next-[generation] techniques,

the colon out as early as possible.” After the colectomy, it is important to assess “the duodenum for adenomas and cancer and [follow] the germline mutation through the family,” he explained. Even with a colectomy, however, patients are still at risk for pancreatic and gastric cancers. A prophylactic colectomy also is an option for patients with MAP, but in milder cases of the syndrome, an annu-

Interpretation Lags Behind Gene Sequencing Despite the obvious advantages of screening, Dr. Boland concluded his presentation by discussing some of the issues concerning diagnostic testing panels. Testing of multiple genes, for example, may uncover sequence variations that suggest a functional change in the gene, but it may not be causing the cancer—or cancer risk—in that patient or family. “We can

‘With colonoscopies and some occasional extra surgery, [clinicians] can turn Lynch syndrome into a fairly “boring” disease—without the big surprise of cancer.’ —C. Richard Boland, MD Familial adenomatous polyposis

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MutYH-associated polyposis

MutYH gene 1p34

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‘Taking the family history first is critically important. … Because there are many “pseudo types” that are not actually Lynch syndrome, you must talk to the patient to help determine this. ... Nothing makes sense until you have family history.’ —Thomas Seufferlein, MD such classification is rarely as straightforward as it might sound. “There’s not a simple black line between polyposis and nonpolyposis,” Dr. Boland said. Focusing his presentation on two polyposis syndromes—familial adenomatous polyposis (FAP) and MutYHH associated polyposis (MAP)—as well as on the nonpolyposis Lynch syndrome, Dr. Boland explained that “classic polyposis is more than 100 polyps, and in the case of [FAP] and [MAP], they’re all adenomatous polyps.” But, he added, “attenuated forms of FAP and a lot of MAP [cases] have fewer than 100.” With Lynch syndrome, he said, generally patients have “about three polyps by age 30 and about six polyps by age 50, but there are often patients who have more than this.” FAP is caused by inactivating germline mutations in the APC C gene (Figure). Noting that APC C is a large gene, with

that is probably going to [become] the standard.” Lynch syndrome is autosomal dominant and caused by a germline mutation in one of four DNA mismatch repair genes. “Almost all the tumors have microsatellite instability (MSI),” he said, “and the tumors show absence of the expression of the mutating gene, so these are always inactivating mutations.” More than two-thirds of the cancers caused by Lynch syndrome occur in the proximal colon, but there’s an increased risk for other tumors, too, including endometrial, gastric and urinary tract tumors.

Treatment Approaches “We treat FAP with a prophylactic colectomy in the late teens or early 20s,” Dr. Boland said. “It’s important for the child to be fully grown to be able to tolerate the surgery … but you want to get

APC gene 5q21 q

Figure. Adenomatous polyposis colii and MutYH H genes. Source: http://www.genetics4medics.com/familial-adenomatous-polyposis.html.

al colonoscopy can suffice, according to Dr. Boland. “Treatment has to be individualized based on the patient’s willingness and availability to get follow-up and tolerate some degree of uncertainty in exchange for keeping the colon in place,” he said. “For Lynch syndrome, we don’t usually go to a prophylactic colectomy; an annual colonoscopy will do,” Dr. Boland noted. “For women with this disease,” he said, “removal of the uterus and ovaries after childbirth is recommended, especially in Lynch syndrome MSH6 type.” If colon cancer is found in conjunction with Lynch syndrome, however, Dr. Boland suggested a colectomy preserving the rectum, and an ileorectal or ileosigmoid anastomosis. He also noted that patients with Lynch syndrome, and possibly others with MSI, may not respond to 5-fluorouracil–based chemotherapy.

now sequence many genes that we cannot interpret,” Dr. Boland cautioned. Asked to comment on the presentation, Thomas Seufferlein, MD, from Ulm University Hospital, in Ulm, Germany, strongly agreed that screening should be performed routinely. “The trouble is,” he said, “it starts with taking proper history of patients, which is not often done or done correctly. … The simple things are those that are usually forgotten. We are prone to say, ‘let’s get this to pathology,’ but taking the family history first is critically important. ... You have to know what you actually want. Because there are many ‘pseudo types’ that are not actually Lynch syndrome, you must talk to the patient to help determine this. ... Nothing makes sense until you have family history.” Drs. Boland and Seufferlein reported no relevant financial relationships.

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GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / MAY 2015

Gastrointestinal Cancers

Are We Ready for Molecular Profiling: A Debate B Y C HASE D OYLE SAN FRANCISCO—In a debate at the 2015 Gastrointestinal Cancers Symposium, Peter J. O’Dwyer, MD, the program leader in developmental therapeutics at the University of Pennsylvania’s Abramson Cancer Center, in Philadelphia, advocated the merits of ordering molecular profiling for patients, whereas Neal J. Meropol, MD, associate director of clinical programs at University Hospital’s Seidman Cancer Center, in Cleveland, argued that such testing is unnecessary and costly. The following is a summary of the debate. Highlighting the decreasing costs and increasing availability of molecular profiling, Dr. O’Dwyer said that next-generation sequencing panels have been made available at many academic and commercial institutions due to a dramatic reduction in sequencing costs. “We’re currently around the area of $5,000 to $6,000 per test for comprehensive genomic sequencing,” he said. “We’re well within the range of feasibility already, and we expect them to become less expensive.”

trials,” he said, “and we determined 42% of patients could have a therapy that was directed by the assay.” According to Dr. O’Dwyer, the distribution found at the University of Pennsylvania was similar to databases with much larger numbers of colorectal cancer, and there also is applicability outside colon cancer, across other malignancies.

Whom To Test? Acknowledging that clinicians can’t at this point recommend “who should get tested,” Dr. O’Dwyer said, “Genetic analysis is not really standard of care and hasn’t been validated yet to contribute to the overall benefit of patients.” However, he did recommend who shouldn’t get tested. “Patients who don’t need treatment or those too sick to avail [themselves] of a treatment are not good candidates because testing can’t do them any good,” he said. “I think it’s also important to recognize that positive findings are not equally likely across all [gastrointestinal] malignancies.” He concluded that given that response to therapy based on genomic profiling cur-

‘Sensitivity for base substitution is in excess of 99.9% positive predictive value for these assays, which is very high ....’ —Peter J. O’Dwyer, MD

He emphasized the flexible nature of the technology, which allows for broad coverage of the whole expressed panel or highly targeted areas of sequence. “Is it valid?” he rhetorically asked the audience. “Sensitivity for base substitution is in excess of 99.9% positive predictive value for these assays, which is very high indeed. … So, yes, I think the technology is robust and reliable.”

Finding Actionable Mutations Dr. O’Dwyer described his center’s experience with personalized diagnostics for colorectal cancer to support the idea that such testing provides information that can be clinically useful. Of the 101 patients sequenced using Illumina MiSeq platform, 95% had at least one mutation, with a median of two and a mean of 2.46 mutations. “We conservatively used about seven abnormalities that we defined as actionable, either through standard therapies or clinical

rently is anecdotal, the key benefit to a patient is the potential eligibility for a research trial.

Limitations and Risks In opposition to Dr. O’Dwyer’s position, Dr. Meropol outlined reasons why clinicians should hesitate before succumbing to pressure to routinely test all tumors. One item on his list of concerns was assay platform limitations. He noted potential variability in the sensitivity and specificity of numerous platforms being promoted. “How are the genes selected for these panels?” he asked. “Does the platform look at the transcriptome or just the genome? Are we looking at epigenomic changes? What’s the turnaround time for results? Who is interpreting? Who is annotating? And what is the cost?” Dr. Meropol also cited the complexity and heterogeneity of tumors as a concern. Depending on where one

biopsies the tumor, the mutations identified may differ among sites. “Not all of these tumors are the same,” he said. “Although they may look the same under a microscope, colon cancers and gastric cancers are extremely complex and extremely heterogenous in terms of their molecular profile.” According to Dr. Meropol, definitions used for identifying drivers in a clinical trial are not yet good enough for routine clinical care. Nor does finding a single driver mutation guarantee a single, effective drug intervention because of “crosstalk” between pathways that occurs downstream of a key mutation. “These are costly interventions,” he said. “They may not work, and they have side effects. This should not be our routine approach with patients.” ients. For Dr. Meropol, the llimited availability of investigatiional drugs and clinical triial sites provided further evidence of the drawbackss to genetic profiling. “Not everybody lives in closse proximity to a research ceenter,” he said, “and getting ccompassionate access to a new w drug in development is a logisticallly complicated process.”

‘These are costly interventions. They may not work and they have side effects. This should not be our routine approach with patients.’ —Neal J. Meropol, MD

Costly Interventions, Unintended Consequences Payment also is a problem, Dr. Meropol argued. Increasingly, payors are scrutinizing off-label use of expensive targeted agents, resulting in costs falling on patients. “Recommending cancer drugs with high copays may not be ethical without strong evidence that they are going to help that individual patient,” he said. Given the potential for confusion over interpretation, Dr. Meropol stressed the importance of knowing who is interpreting the data and making recommendations. He concluded his talk with a focus on the patients. “We don’t want to give our patients false hope,” he said. “We don’t want to subject them to the risks of needless biopsies, and we don’t want to subject them to the financial

burden of therapies and procedures that are not destined to help.” After both speakers completed their presentations, the audience response shifted somewhat. After the presentations, fewer participants stated that they would routinely order genomic tests than had indicated they would in a baseline survey before the debate. Nevertheless, 60% of the audience polled still said they would recommend an assay for a patient with metastatic colon cancer refractory to treatment if the gene-sequencing panel was covered by insurance.

Dr. Meropol reported that he has consulted for BioMotiv. Dr. O’Dwyer reported no relevant financial relationships.

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In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / MAY 2015

Liposomal-Encased Bupivacaine Offers Advantages in Breast Surgery B Y C AROLINE H ELWICK

MIAMI—Liposomal-encased bupivacaine (LEB) is a good, cost-effective medical choice for pain control after breast surgery. Valerie Lemaine, MD, MPH, an assistant professor of plastic surgery and the vice chair for research at Mayo Clinic College of Medicine, Rochester, Minn., reviewed her experience at the 32nd

Annual Miami Breast Cancer Conference. She noted that the drug has proved safe, decreased opioid requirements and reduced costs for patients having breast surgery at Mayo Clinic. LEB is a recently approved formulation of bupivacaine loaded in multivesicular liposomes, which allows slow release from the liposome and increases the duration of local anesthetic action (Figure). LEB is FDA-approved for

postoperative analgesia when given as a single-dose surgical site injection. In breast surgery, LEB has been used in patients after mastectomy, lumpectomy, and autologous and implant-based reconstruction. As background, Dr. Lemaine emphasized the frequency at which postsurgical pain and chronic pain are inadequately managed. Among almost 500,000 breast surgical procedures

performed annually in the United States, as many as half may result in chronic postoperative pain of the scar, breast, chest wall, shoulder or arm as a result of nerve injury, inflammation or inadequate management of acute pain, she said. “In my opinion, this is a significant problem for these women, especially with breast cancer treatments available today that positively impact survival. Now that women live longer after diagnosis, quality of life becomes more important and living pain-free is a key component,” she said.

Among almost 500,000 breast surgical procedures performed annually in the United States, as many as half may result in chronic postoperative pain of the scar, breast, chest wall, shoulder or arm as a result of nerve injury, inflammation or inadequate management of acute pain. Pharmacokinetics

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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.

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Plasma levels of LEB can persist up to 96 hours, although in Dr. Lemaine’s experience, 72 hours is more likely. The pain relief provided by LEB has best been observed in patients who undergo microsurgical breast reconstruction and are typically hospitalized for three to four days. “You can really see a difference around day 3, when patients start taking more oral medications for pain control because the liposomal bupivacaine is starting to wear off,” she said. Dr. Lemaine said she dilutes the drug with preservative-free normal saline, up to a total of 260 cc, but also occasionally injects it undiluted, depending on the situation. LEB must be injected within four hours of preparation, a characteristic she makes sure to communicate to the surgical team. Showing a video of how she uses LEB in tissue expander breast reconstruction, she noted, “I perform a field block and inject the entire surgical site following the mastectomy. The injection is intramuscular and sometimes also subcutaneous. I adjust the dilution and, for example, in very large-breasted women, I may increase my dilution. I

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GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / MAY 2015

Liposomal encased bupivacaine (LEB) Outer lipid membrane

Chambers w/drug

Inner lipid membranes Released drug 15-50 μm

Figure. The bupivacaine is located within multivesicular liposomes, akin to the structure of a pomegranite, which increases the duration of anesthetic action. make these decisions intraoperatively, on a case-by-case basis, based on body habitus and size of the surgical site.” When mastectomy skin flaps are sufficiently thick, she may inject subcutaneously, addressing the subclavicular area and lateral subcutaneous tissue before inserting tissue expanders. Although reports suggest that other anesthetic agents can be used safely in conjunction with liposomal bupivacaine, Dr. Lemaine has not personally done so.

LEB versus Paravertebral Block Dr. Lemaine and her colleagues recently compared patients who had LEB or paravertebral block in conjunction with mastectomy and immediate breast reconstruction using tissue expanders. “Regional block is our standard of care postmastectomy but, having a good experience with LEB in microsurgical breast reconstruction, we thought LEB could be useful when we used tissue expanders.” In this retrospective (and unpublished) evaluation, LEB offered a number of advantages, she said. Patients receiving LEB required less opioids in the recovery room, had a longer time-tofirst opioid use, required fewer postoperative antiemetics on day 1 and had lower mean pain scores on postoperative day 0. LEB was also less time consuming, she added. “Paravertebral blocks take time— adding about 45 minutes to a procedure at my institution—and this has been a source of frustration for our plastic surgeons.” Paravertebral blocks also carry a small risk for pneumothorax, she added. “In my two years of experience with LEB,” Dr. Lemaine concluded, “I have found this to be safe, to make a difference to my patients and to be cost saving. I do think there’s a learning curve, so surgeons should not get discouraged. Good communication with anesthesiology and with postoperative nursing is key to providing the best analgesia, and

10 cm

to improving outcomes overall.” Basavana Goudra, MD, of the University of Pennsylvania, Philadelphia, commented on the presentation in an interview. He noted that LEB is used in various other procedures, such as hemorrhoidectomy, bunionectomy, colectomy and total knee arthroplasty. It has proved beneficial in placebo-controlled studies; however, a statistically significant advantage has not been shown when compared with bupivacaine with epinephrine, he said. “The nature of release and later metabolism might give LEB a safety

advantage. A reduction in the total dose of bupivacaine needed to achieve a clinical benefit is another reported benefit,” Dr. Goudra said. In research settings, LEB is used both as epidural and perineural injections, which can produce prolonged sensory blockade, an important feature. Currently, however, it is not approved by the FDA for routes other than wound infiltration, he added. There were no relevant financial disclosures.

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In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / MAY 2015

Surgeons Want Robotics Training During General Surgery Residency B Y P AUL B UFANO CHATTANOOGA, TENN.—The vast majority of residents and attendings believe that robotics should be included in general surgery training and that it should start in the first year, according to the results of a single-center study presented at the 2015 Southeastern Surgical Congress Annual Meeting. Despite this finding, there is not yet

enough literature to begin formulating how standardized robotics education should be achieved, said investigator Heather R. Nolan, MD, a general surgery resident at Mercer University School of Medicine/The Medical Center-Navicent Health, in Macon, Ga. “There are no defined national guidelines for robotic surgery and as such, the resident and attending surgeon must work in partnership to define robotic education,� she said. “I wanted to

uncover what skills attendings desired of residents before giving them the opportunity to work on the console, and conversely, how residents felt about these requirements and the ability to achieve these prerequisites.� In the study, which included 25 respondents, investigators gave a 15to 17-question, multiple-choice survey to private and academic attending surgeons and postgraduate residents years 1 to 5. For attendings, questions covered

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the physician’s work in robotics, experience as an attending and type of practice. For residents, questions included year in training, laparoscopic experience and robotics experience. The resident survey was longer because it involved additional questions about the training received as part of general surgery education.

100% of attendings believed there should be robotics training in surgical residency, and 60% said training should start in year 1. Similarly, 93% of residents wanted robotics training in surgery residency, and 67% said training should start in the first year. The results showed that 100% of attendings believed there should be robotics training in surgical residency, and 60% said training should start in year 1. Similarly, 93% of residents said there should be robotics training in surgery residency, and 67% said training should start in the first year. Furthermore, 40% said they definitely anticipated using robotics in the future, while 40% were uncertain and 20% said they did not expect so. Dr. Nolan said the next step is to create a curriculum that is comprehensive and reproducible. This could have major clinical implications by improving treatment and patient survival, she continued. “The more we see, the more we do, and the better we are, which is why as residents we go to the operating room as much as we can,� she said. “Robotic surgery is not appropriate in all settings, but for the right patient and operation, it can be the best method. When we graduate, the more exposure we have to robotic surgery, the better we will be as robotic attendings. This cascades into better decision making, more refined skill sets, and in turn, improved patient outcomes.� Dr. Nolan reported no conflicts of interest.

Š 2014 Vector Surgical, LLC ZÄžĨÄžĆŒÄžĹśÄ?ÄžĆ?Í— ŚĂŜĚ͕ E͖͘ ÄžĆŒĆšĆ?Ć?ĞŜ͕ ͖͘ ĂŜĚ ZŽLJůĞ͕ '͘ Íž džĹ?ĹŻĹŻÄ‚ĆŒÇ‡ Íš džÄ?ĹŻĆľĆ?Ĺ?ŽŜÍ› Íś ^ĆľÄ?Ä?ÄžĆ?Ć?Ĩƾů dÄžÄ?ŚŜĹ?ƋƾĞ ĨŽĆŒ ZĞĚƾÄ?Ĺ?ĹśĹ? ^ÄžĆŒŽžÄ‚ &Ĺ˝ĆŒĹľÄ‚Ć&#x; ŽŜ ĹŒ ÄžĆŒ DÄ‚Ć?ƚĞÄ?ĆšŽžÇ‡ ĂŜĚ džĹ?ĹŻĹŻÄ‚ĆŒÇ‡ Ĺ?Ć?Ć?ÄžÄ?Ć&#x; ŽŜ͘Í&#x; Advances in Breast Cancer Research 2 ͞ώϏϭϯͿÍ— ϭͲϲÍ– ĹšÄ‚ĆŒĹľÄ‚Ç Ä‚ĹśÍ• Z͖͘ EÄ‚Ĺ?Ä‚ĹŻĹ?ĹśĹ?Ăž͕ ^͖͘ dĂLJ͕ >͖͘͘ tŽŜĹ?Í• ͖͘ ĂŜĚ dĂŜ͕ ͘ ÍždŚĞ hĆ?Äž ŽĨ ŽžĆ‰ĆŒÄžĆ?Ć?Ĺ?ŽŜ Ğůƚ Ĺ?Ĺś ƚŚĞ WĆŒÄžÇ€ÄžĹśĆ&#x; ŽŜ ŽĨ ^ÄžĆŒŽžÄ‚ &Ĺ˝ĆŒĹľÄ‚Ć&#x; ŽŜ WĹ˝Ć?ĆšͲ ĆŒÄžÄ‚Ć?Ćš Ä‚ĹśÄ?ÄžĆŒ ^ĆľĆŒĹ?ÄžĆŒÇ‡Í— ZĂŜĚŽžĹ?njĞĚ dĆŒĹ?Ä‚ĹŻÍ˜Í&#x; WĹ˝Ć?ĆšÄžĆŒ Ć?ÄžĆ?Ć?Ĺ?ŽŜ Ć‰ĆŒÄžĆ?ĞŜƚĞĚ Ăƚ͗ DĹ?ĹŻÄ‚Ĺś ĆŒÄžÄ‚Ć?Ćš Ä‚ĹśÄ?ÄžĆŒ ŽŜĨÄžĆŒÄžĹśÄ?Ğ͖ ĎŽĎŹĎ­ĎŻ :ƾŜÄž ώϏͲώϭÍ– DĹ?ůĂŜ͕ /ƚĂůLJ͖ <ŽŜƚŽĆ?Í• D͖͘ WÄžĆšĆŒŽƾÍ• ͖͘ WĆŒÄ‚Ć?Ć?Ä‚Ć?Í• ͖͘ dĆ?Ĺ?Ĺ?ĆŒĹ?Ć?Í• ͖͘ ZŽLJ͕ W͖͘ dĆŒÄ‚ĨÄ‚ĹŻĹ?Ć?Í• ͖͘ Ä‚Ć?ĆšŽƾŜĹ?Ć?Í• ͖͘ ĂŜĚ <Ä‚ĆŒÄ‚ĹľÄ‚ĹśÄ‚ĹŹĹ˝Ć?Í• W͘ ÍžWĆŒÄžĆ?Ć?ĆľĆŒÄž ĆŒÄžĆ?Ć?Ĺ?ĹśĹ? Ĺ?Ĺś ĆŒÄžÄ‚Ć?Ćš ^ĆľĆŒĹ?ÄžĆŒÇ‡Í— /Ć? dĹšĹ?Ć? ƚŚĞ ^ŽůƾĆ&#x; ŽŜ ĨŽĆŒ ^ÄžĆŒŽžÄ‚ &Ĺ˝ĆŒĹľÄ‚Ć&#x; ŽŜÍ?Í&#x; Journal of B.U.ON. 13.1 (2008): 65-67.

khorty@mcmahonmed.com.

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GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / MAY 2015

13

Robert Bárány: Nobel Surgeon’s Study of Ear Remains Relevant Unlocks Function of Vestibular Apparatus, Which Affects Eyes, Balance and Coordination B Y V ICTORIA S TERN

A

lthough the inner ear may not come to mind when considering an essential part of the body, this structure wields incredible control over us. In the early 1900s, Robert Bárány, a surgeon from Vienna, investigated the functions of the vestibular apparatus, the sensory system that provides the greatest influence on movement and balance. He developed caloric, rotational and pointing tests to examine each ear individually; described nystagmus, a condition defined by involuntary eye movement; and unraveled the relationship between the inner ear and the brain. Dr. Bárány’s pioneering work on the physiology and pathology of the vestibular apparatus was recognized by the Nobel Committee, and in 1914, he was awarded the Nobel Prize in Physiology or Medicine, becoming the fourth surgeon to ever receive this honor. Today, more than a century after his discoveries, Dr. Bárány’s insights and tests remain relevant to otolaryngology. “Dr. Bárány’s contribution to our understanding of the vestibular system remains a great accomplishment,” said Ann Tucker Gleason, PhD, associate professor of clinical otolaryngology and director of the Vestibular and Balance Center, Department of Otolaryngology– Head and Neck Surgery at the University of Virginia School of Medicine, Charlottesville. “There are very few other things in medicine that we are still using 100 years later in almost the exact same way.” Robert Bárány was born on April 22, 1876, near Vienna. His father, Ignaz Bárány, managed a farm estate and his mother, Marie Hock Bárány, was the daughter of a well-known Prague scientist, whose intellectual ideas deeply influenced her family, especially her son. As a child, Dr. Bárány came down with tuberculosis of the bone, which caused permanent stiffness in his legs. He managed, however, to overcome his troubles by playing tennis throughout his life. “In fact, this illness may have helped fuel his interest in science and medicine,” Dr. Tucker Gleason said. Dr. Bárány was an excellent student, and in 1890, he received his medical degree from the University of Vienna. After his medical studies, Dr. Bárány lived in Germany for two years where his interest in neurology emerged and blossomed. He studied internal medicine in Frankfurt with pathologist and internist Carl von

Noorden as well as neurology and psychiatry in Heidelberg under Emil Kraepelin, who is considered the founder of modern scientific psychiatry. On his return to Vienna, Dr. Bárány received hospital surgical training. In 1903, Dr. Bárány began working in the otology clinic at the University of Vienna, directed by Adam Politzer, who had established the specialty in Austria. As a young scientist caring for patient after patient in the clinic, Dr. Bárány

began to see interesting patterns emerge. Most notably, after syringing patients’ ears, Dr. Bárány noticed that many complained of vertigo. He also observed that these patients experienced nystagmus. Although Dr. Bárány knew something important was happening, he only unlocked the mystery after a particularly serendipitous encounter with a patient. One day in the clinic, while syringing a patient’s ear, Dr. Bárány recalled the patient saying: “Doctor, I only get giddy

when the water is not warm enough. When I do my own ears at home and use warm enough water, I never get giddy.” Dr. Bárány subsequently asked a nurse to give him warmer water for the syringe, and upon irrigation of the ear canal with warm water the patient exclaimed: “But Doctor, this water is much too hot and now I am giddy again.” Dr. Bárány immediately observed the patient’s eyes and saw the direction of Nobel

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Ξ ϮϬϭϰ sĞĐƚŽƌ ^ƵƌŐŝĐĂů͕ >> ZĞĨĞƌĞŶĐĞƐ͗ ;ϭͿ ŽŽůĞLJ͕ t͘ ͘ ĂŶĚ WĂƌŬĞƌ͕ :͘ ͞hŶĚĞƌƐƚĂŶĚŝŶŐ ƚŚĞ DĞĐŚĂŶŝƐŵƐ ƌĞĂƟ ŶŐ &ĂůƐĞ WŽƐŝƟ ǀĞ >ƵŵƉĞĐƚŽŵLJ DĂƌŐŝŶƐ͘͟ American Journal of Surgery ϭϵϬ ;ϮϬϬϱͿ͗ ϲϬϲͲϲϬϴ͘ ;ϮͿ ƌŝƩ ŽŶ͕ W͘ ͖͘ ^ŽŶŽĚĂ͕ >͘/͖͘ zĂŵĂŵŽƚŽ͕ ͘<͖͘ <ŽŽ͕ ͖͘ ^ŽŚ͕ ͖͘ ĂŶĚ 'ŽƵĚ͕ ͘ ͞ ƌĞĂƐƚ ^ƵƌŐŝĐĂů ^ƉĞĐŝŵĞŶ ZĂĚŝŽŐƌĂƉŚƐ͗ ,Žǁ ZĞůŝĂďůĞ ƌĞ dŚĞLJ͍͟ European Journal of Radiology ϳϵ ;ϮϬϭϭͿ͗ ϮϰϱͲϮϰϵ͘ ;ϯͿ DŽůŝŶĂ͕ D͘ ͖͘ ^ŶĞůů͕ ^͖͘ &ƌĂŶĐĞƐĐŚŝ͕ ͖͘ :ŽƌĚĂ͕ D͖͘ 'ŽŵĞnj͕ ͖͘ DŽī Ăƚ͕ &͘>͖͘ WŽǁĞůů͕ :͖͘ ĂŶĚ ǀŝƐĂƌ͕ ͘ ͞ ƌĞĂƐƚ ^ƉĞĐŝŵĞŶ KƌŝĞŶƚĂƟ ŽŶ͘͟ Annals of Surgical Oncology ϭϲ ;ϮϬϬϵͿ͗ ϮϴϱͲϮϴϴ͘ ;ϰͿ DĐ ĂŚŝůů͕ >͘ ͖͘ ^ŝŶŐůĞ͕ Z͘D͖͘ ŝĞůůŽ ŽǁůĞƐ͕ ͘:͖͘ &ĞŝŐĞůƐŽŶ͕ ,͘^͖͘ :ĂŵĞƐ͕ d͘ ͖͘ ĂƌŶĞLJ͕ d͖͘ ŶŐĞů͕ :͘D͖͘ ĂŶĚ KŶŝƟ ůŽ͕ ͘ ͘ ͞sĂƌŝĂďŝůŝƚLJ ŝŶ ZĞĞdžĐŝƐŝŽŶ &ŽůůŽǁŝŶŐ ƌĞĂƐƚ ŽŶƐĞƌǀĂƟ ŽŶ ^ƵƌŐĞƌLJ͘͟ :ŽƵƌŶĂů ŽĨ ƚŚĞ ŵĞƌŝĐĂŶ DĞĚŝĐĂů ƐƐŽĐŝĂƟ ŽŶ ϯϬϳ͘ϱ ;ϮϬϭϮͿ͗ ϰϲϳͲϰϳϱ͘

14

Stitches NOBEL

jcontinued from page 13 the nystagmus had changed after he had switched from cold to hot water. In that moment, Dr. Bárány understood what was causing nystagmus: “It came to me then in a flash that obviously the temperature of the water was responsible for the nystagmus. From this, I immediately drew certain conclusions. If the temperature of the water was really responsible, then water at exactly body temperature should cause neither nystagmus nor vertigo. An experiment

confirmed this conclusion. Furthermore, I said to myself, if it is the temperature of the water, nystagmus must be caused in normal cases also and not only in cases of suppurating ears. This I was also able to prove.” By 1906, Dr. Bárány had developed a simple test, called the Bárány caloric test, which he used to diagnose problems with the semicircular canals of the inner ear by syringing the ear with either hot or cold water. The test could discern the degree of responsiveness of the vestibular system and how symmetric the responses were between left and right ears.

“Dr. Bárány’s keen clinical observation led him to this critical discovery,” Dr. Tucker Gleason said. “For the first time, physicians could induce a sense of rotation without actually rotating the patient, but by irrigating the ear canal with water that was above or below body temperature. Importantly, he had also devised a way to test each ear individually without destroying either.” Dr. Bárány soon found that the endolymph—the body temperature fluid contained in the labyrinth of the inner ear—displaced itself, sinking in the presence of hotter water and rising in the

Proven Performance

The Bárány rotating chair revealed the function of both inner ears together and made surgical treatment of vestibular organ diseases possible. Development of the chair led to Bárány receiving the Nobel Prize in 1914. Source: The National Institutes of Health

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presence of colder water. He realized that the motion of fluid affected the nerves in the semicircular canal, which are in direct contact with those that control the central eye muscles. “We can understand, therefore, why stimulation of the semicircular canal causes nystagmus of the eyes,” Dr. Bárány explained in his Nobel speech. “The importance of this reaction in the diagnosis of diseases of the inner ear was obvious.” Notably, the semicircular canal nerve also branches into the cerebellum, which controls motor function throughout the body. Thus, he found that disturbances of the semicircular canal not only caused nystagmus, but could also explain the resulting problems with balance and coordination. If patients did not respond to such disturbances, he knew that the semicircular canals had been severely damaged or destroyed. Dr. Bárány’s work led him to develop the Bárány rotating chair, which revealed the function of both inner ears together, and made surgical treatment of vestibular organ diseases possible. The scientific establishment immediately recognized Dr. Bárány’s pivotal work and awarded him the Nobel Prize in 1914. At the time, however, Dr. Bárány was serving as a civilian surgeon in the Austrian Army in World War I. During these years, Dr. Bárány observed the effect of head injuries on coordination and continued to study the connection between the vestibular apparatus and nervous system. He also developed a technique for suturing head wounds and caring for bullet wounds to the brain. In April 1915, Dr. Bárány was captured by Russian troops and held prisoner in a Russian war camp. In 1916, Prince Carl of Sweden intervened on his behalf and negotiated his release. That year, Dr. Bárány attended the Nobel Prize awards

Stitches ‘For the first time, physicians could induce a sense of rotation without actually rotating the patient, but by irrigating the ear canal with water that was above or below body temperature.’ —Ann Tucker Gleason, PhD of [a] scientist, carefully observing his patients, creating hypotheses and testing them,” said Dr. Tucker Gleason.

ceremony and officially received his prize. Despite his accomplishment and harrowing wartime experiences, Dr. Bárány was welcomed home to Vienna with controversy, not open arms. Some of his colleagues felt he had taken credit for others’ ideas, such as the caloric reaction, and presented them as his own. Although such controversy over intellectual ownership is quite common for Nobel Prize winners, the accusations in this case seemed exaggerated. Dr. Bárány had made no secret of the strong influence his predecessors had imparted on him. In fact, Dr. Bárány spent about half his Nobel speech giving credit to his peers for their important contributions. In his lecture, Dr. Bárány referenced the work of Prosper Ménière who observed vertigo and tinnitus in inner ear disease in 1861; he discussed the efforts of Friedrich Goltz who, in 1870, deduced that the semicircular canal apparatus must maintain balance; and he referenced the theories of Josef Breuer, Ernst Mach and Alexander Crum-Brown, who all independently uncovered that the semicircular canal was a sensory organ necessary for the perception of rotary motion and responsible for vertigo. He also spoke highly of the experiments of Dutch anatomist Louis Balk and physiologist W. Trendelenburg, who elucidated key functions of the cerebellum in mammals. The Nobel Prize committee investigated these accusations and concluded they were foundationless, but the controversy was strong enough to push Dr. Bárány out of Vienna. In 1917, he moved to Sweden and became director of the otorhinolaryngology clinic at the University of Uppsala. There, he focused on the function of the cerebellum and the causes of muscular rheumatism, and developed a surgical technique for treating chronic sinusitis, for which he received the Jubilee Medal of the Swedish Society of Medicine in 1925. Although little is known of his personal life, Dr. Bárány was reportedly a quiet man who was devoted to his work. “From his Nobel speech, one can glean that he was good-natured and had the keen mind

Dr. Bárány married Ida Felicitas Berger in 1909 and had three children, all of whom entered the sciences—one son became a professor of internal medicine, another son became a professor of pharmacology and his daughter became a psychiatrist. In the last years of his life, Dr. Bárány had several strokes, which left him partially paralyzed, and he died in Uppsala on April 8, 1936, just short of his 60th birthday. Reflecting on Dr. Bárány’s legacy, Dr. Tucker Gleason said, “Dr. Bárány provided us with a test that can be

15

easily applied in the clinic with very basic equipment to determine whether a person’s inner balance sensors are functioning as they should.” Not only is Dr. Bárány’s work still used in the clinic today, but also, with the growing aging population, his work on balance has become increasingly important. “Falls are a leading cause of accidental death and injury in people over [age] 65,” said Dr. Tucker Gleason. “Alongside dementia, balance issues in the elderly are becoming a public health crisis, which makes Dr. Bárány’s work more relevant than ever before.”

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THE SCIENCE BEHIND POSITIVE PATIENT OUTCOMES

Perioperative Goal-Directed Therapy: Optimizing Fluid Management and Reducing Postoperative Complications Faculty Timothy E. Miller, MB, ChB, FRCA

Michael (Monty) G. Mythen, MBBS, MD, FRCA, FFICM

Associate Professor of Anesthesiology Department of Anesthesiology Duke University Medical Center Durham, North Carolina

Smiths Medical Professor of Anaesthesia and Critical Care Director Centre for Anaesthesia University College London Hospitals London, United Kingdom

Introduction Perioperative goal-directed therapy (PGDT) is a cliniciandirected protocol that uses measurements of advanced hemodynamic parameters during surgery to guide fluid management.1 The accurate assessment of hemodynamic parameters—stroke volume (SV), stroke volume variation (SVV), and cardiac output (CO)—allows for individualized volume management and decreases variability among clinicians because fluids are given only when there is demonstrable fluid responsiveness.1 Implementation of PGDT has been shown to improve patient outcomes and can be applied alone or as part of larger protocol initiatives, such as enhanced recovery after surgery (ERAS) and perioperative surgical home programs.1,2 The goal of ERAS is for patients to achieve earlier recovery after surgery. Minimally invasive surgery with appropriate fluid and pain management are central elements of ERAS.1,2 Noninvasive and minimally-invasive monitoring systems, which provide these continuous measurements of CO, SV, and SVV, expand the benefits of PGDT and ERAS to more patients.1

Fluid Management Optimal fluid management is a multidisciplinary process that requires a continuum of care through the preoperative, intraoperative, and postoperative phases.2 In the preoperative phase, routine mechanical bowel preparation should be avoided, and overnight fasting is no longer recommended.2,3 Patients may consume a clear carbohydrate beverage 2 to 3 hours before surgery.3,4 The goals of these methods are to have a euvolemic patient who feels fed before surgery.2 Intraoperative fluid management involves maintaining central euvolemia while minimizing excess salt and water.2 Achieving these goals requires maintaining background fluid therapy and using volume therapy to restore fluid as necessary.2 Maintenance fluid replacement replenishes fluid lost by urinary output as well as perspiration.2 Despite these clear physiologic goals, intraoperative fluid management remains challenging.2,5 Blood loss and fluid

16

GENERAL SURGERY NEWS • MAY 2015

Anthony Senagore, MD General and Colon & Rectal Surgeon University Hospitals Parma Medical Center Parma, Ohio

shifts during surgery may lead to hypovolemia, hypoperfusion, and adverse events (Figure).1,2 Conversely, the administration of excess fluid may result in tissue edema.2 Administering excess fluid causes increased intravascular pressure and possible damage to the endothelial glycocalyx.2 Excess fluid may be administered under conditions that are incorrectly interpreted as fluid deficit, and until recently, belief in a “third space” (ie, a concept by which fluid was stored within an extravascular, extracellular space) often resulted in liberal administration of fluid during surgery.1 The existence of the “third space” is not supported by current evidence.6

Determining Fluid Needs During surgery, patients with fluid deficits benefit from fluid administration. The decision to provide fluid to a patient is based on a fluid challenge that identifies fluid responsiveness.2 When there is evidence of intravascular hypovolemia, a fluid challenge is administered rapidly over 5 to 10 minutes.2,7 Measurement of hemodynamic parameters will indicate when patients are replete and fluid administration should halt.2,5 However, traditional methods used to guide fluid management, such as heart rate, urine output, mean arterial pressure, and central venous pressure, are unreliable measures of intravascular volume status.2 PGDT uses a non- or minimally invasive measurement of SV or SVV to monitor the response to a fluid challenge.2 Patients who respond to a fluid challenge with an increase in SV of more than 10% are considered fluidresponsive and may benefit from additional fluid challenges. Euvolemic patients will not exhibit a change in SV greater than 10% and are not likely to benefit.2 SVV is an assessment of the expiratory and inspiratory decreases of the arterial pulse pressures caused by intrathoracic pressure as compared with negative pressure ventilation.8 Therefore, accurate hemodynamic monitoring of CO, SV, and SVV allows physicians to provide fluid as needed, in appropriate amounts, and with optimal timing.2,5 Modern monitoring systems reliably measure

hemodynamic variables that are the best predictors of fluid responsiveness, such as SV, SVV, pulse pressure variation (PPV), and systolic pressure variation.2 These advanced hemodynamic parameters may indicate hypovolemia before a change in heart rate or blood pressure.9,10 In the postsurgical period, many patients are in positive sodium and fluid balance and also have altered excretion of sodium and chloride. The focus of postoperative fluid management should therefore be to administer lowsodium volume fluids to enable patients to return to fluid and electrolyte homeostasis postoperatively.2 Continued PGDT management in the immediate postoperative period may be useful for maintaining patients in the optimal volume range and/or resuscitating as needed.

Benefit of Perioperative Goal-Directed Therapy Recent research has demonstrated the clinical benefit of PGDT on patient recovery, including reduced postsurgical complications and reduced hospital length of stay (LOS).11-13 A stratified meta-analysis of 5,021 patients from 34 randomized controlled trials compared a restrictive fluid therapy approach with either a liberal fluid therapy without hemodynamic goals (11 studies, 1,160 patients) or PGDT (23 studies, 3,861 patients).11 The outcomes for patients receiving liberal use of fluid without hemodynamic goals was not equivalent to those for patients receiving PGDT, although patients in the PGDT and liberal therapy groups received more fluid than patients in the restrictive groups, but with very different effects. Patients in the liberal fluid group had a higher risk for pneumonia and an increased time to first bowel movement.11 Patients in the PGDT group had a lower risk for pneumonia, fewer renal complications, and shorter LOS. Liberal use of fluids during surgery produced inferior patient outcomes relative to PGDT.11 Other studies of PGDT demonstrated reduced gastrointestinal complications12 and reduced infections relative to control conditions.13 The recently completed OPTIMISE trial evaluated 734 high-risk patients who underwent major gastrointestinal surgery with or without PGDT.14 After adjusting for risk factors, compliance with the protocol, and excluding the 10 patients per center who discontinued the trial, the decrease in postsurgical complications was significant.14 The primary outcome, a composite measure of complications at 30 days postsurgery, trended toward lower values in the PGDT group relative to usual care (36.6% vs 43.4%; P=0.07).14 Similarly, 180-day mortality was reduced in patients in the PGDT group (7.7% vs 11.6%, respectively; P=0.08).14 These results suggest that PGDT could positively

Current Practices Assessment of current practices in high-risk surgery demonstrated low adoption of hemodynamic monitoring practices in the United States and Europe.22 Although written guidelines concerning hemodynamic management were more common in Europe, only 34% of anesthesiologists in Europe and the United States monitored CO in patients undergoing high-risk surgery.22 Of American Society of Anesthesiologists members surveyed, nearly 87% believed that their hemodynamic management could be improved.22 Furthermore, respondents revealed that they associated CO monitoring with the use of a pulmonary artery catheter, indicating that the availability of less invasive monitors is widely known or used in the United States.22 Additionally, the study found that many clinicians monitor central venous pressure despite consistent evidence that filling pressures are unreliable predictors of fluid responsiveness.22,23 Variability among institutions and clinicians may be affected by implementation of clinical guidelines in the United States or application of standardized protocols at individual institutions.

The Economic Opportunity of Reducing Postsurgical Complications ERAS and PGDT have the potential to reduce hospital LOS and medical costs.17,18 Indeed, reductions in hospital

LOS is a consistent finding in studies that used PGDT.11 Consequently, the reduction of LOS may result in considerable cost savings.24 Analysis of data from 75,140 patients who had major non-cardiac surgery in 2011 revealed that 8,421 developed at least one postsurgical complication (morbidity rate, 11.2%).24 The in-hospital mortality of patients with complications was 12.4% compared with 1.4% in patients with no complications (P<0.001).24 Patients with complications had a mean LOS of 20.5 days, whereas the mean LOS for patients without complications was 8.1 days, a difference of 12.4 days (P<0.001).24 The cost of treating postsurgical complications in the study population equaled $252 million in 2011.24 Investigators estimated decreased morbidity as result of implementing PGDT by applying risk ratios from a recent meta-analysis and projected gross savings of $569 to $970 per patient or $43 million to $73 million for the entire study population.24 Postsurgical complications increased costs by 172%.24

Overcoming Barriers to Implementation Implementation of a PGDT protocol involves up-front investment in hemodynamic monitoring systems and thus requires a recognition of value by clinicians and hospital administration.2 However, unfamiliarity with the evidence supporting PGDT is likely to preclude investment of time and resources for systems and training. Furthermore, a lack of understanding of PGDT methods and benefits and related monitoring systems remains a barrier to clinicians, who may have a “good enough” view of existing methods.22 In some cases, clinical practice may be strongly influenced by local conditions rather than published evidence.22 Survey and audit of consultant surgeons found that the least experienced member of a team was often made responsible for postoperative fluid prescription and that fewer than one-half of these clinicians knew the sodium content of normal saline.19,25,26 Leadership efforts may serve to effect change within the multidisciplinary surgical team and involve hospital management.2 A leader in the anesthesia department can draw attention to gaps in knowledge and training and provide education regarding the evidence base for PGDT. In this manner, it may be possible to align clinical and financial objectives and overcome a tendency to silo budgeting. Experience in existing quality programs has demonstrated that data collection and continuing feedback to clinicians are important in maintaining program standards, sustained compliance, and therefore effectiveness.22

Edema Organ dysfunction Adverse outcome

Hypoperfusion Organ dysfunction Adverse outcome

OPTIMAL Bowel ischemia

Bowel wall edema

Hypovolemic

Overloaded

Volume Load

Figure. Fluid volume load versus clinical complications. Based on reference 1.

support the individualization of fluid therapy through PGDT. Maintaining fluid balance has profound effects on patient physiology and may prevent adverse events that occur under conditions of either hypo- or hypervolemia. Accordingly, evidence and clinical care guidelines support optimal fluid management through all 3 phases of surgery.

References 1.

Miller TE, et al. Best Pract Res Clin Anaesthesiol. 2014;28(3): 261-273.

2.

Miller TE, et al. Can J Anaesth. 2014 Nov 13. [Epub ahead of print]

3.

Mythen MG, et al. Periop Med d (Lond). 2012;1:2-4.

4.

American Society of Anesthesiologists Committee On Standards. Anesthesiology. 2011;114(3):495-511.

5.

Edwards ME, et al. Extrem Physiol Med. 2014;3:16-24.

6.

Jacob M, et al. Best Pract Res Clin Anaesthesiol. 2009;23: 145-157.

7.

Cecconi M, et al. Curr Opin Crit Care. 2011;17:290-295.

8.

Michard F. Anesthesiology. 2005;130(2):419-428.

9.

Kungys G, et al. Anesth Analg. 2009;109(6):1823-1830.

10.

Grocott MP, et al. Anesth Analg. 2005;100(4):1093-1106.

11.

Corcoran T, et al. Anesth Analg. 2012;114(3):640-651.

12.

Giglio MT, et al. Br J Anaesth. 2009;103(5):637-646.

13.

Dalfino L, et al. Crit Care. 2011;15(3):R154.

14.

Pearse RM, et al. JAMA. 2014;311(21):2181-2190.

15.

Rhodes A, et al. Intensive Care Med. 2010;36(8):1327-1332.

16.

Grocott MPW, et al. Br J Anaesth. 2013;111(4):535-548.

17.

Miller TE, et al. Anesth Analg. 2014;118(5):1052-1061.

18.

Enhanced Recovery Partnership, National Health Service. http://www.enhancedrecovery.uk. Accessed March 11, 2015.

19.

Powell-Tuck J, et al. http://www.bapen.org.uk/pdfs/bapen_ pubs/giftasup.pdf. Accessed March 11, 2015.

20.

Vallet B, et al. Ann Fr Anesth Reanim. 2013;32(10):e151-e158.

Conclusion

21.

European Society of Cardiology (ESC)/European Society of Anaesthesiology (ESA). Eur Heart J. 2014;35:2383-2431.

PGDT alone or embedded in a larger protocol such as an ERAS or perioperative surgical home has the potential to improve patient outcomes and reduce hospital costs. Modern non- and minimally invasive systems allow for accurate monitoring of fluid needs during surgery and

22.

Cannesson M, et al. Crit Care. 2011;15(4):R197.

23.

Marik PE, et al. Chest. 2008;134(1):172-178.

Disclosures: Dr. Miller reported that he has received honoraria from Edwards Lifesciences and research support from Covidien. Dr. Mythen reported that he has received grant/research support from Deltex Medical and Smiths Medical and honoraria from Baxter Pharmaceuticals, Fresenius Kabi, and BevMD. He also is a consultant for Deltex Medical and Edwards Lifesciences, and is on the speaker’s bureau for BevMD, Deltex Medical, and Edwards Lifesciences. Dr. Senagore reported that he is a consultant for Cubist Pharmaceuticals, Edwards Lifesciences, and Ethicon Endo-Surgery.

24.

Manecke GR, et al. Crit Care. 2014;18(5):556-574.

25.

Walsh SR, et al. Ann R Coll Surg Engl. 2005;87(2):126-130.

26.

Lobo DN, et al. Clin Nutr. 2001;20(2):125-130.

GENERAL SURGERY NEWS • MAY 2015

BB152

affect recovery and long-term survival after surgery. Other studies also have indicated PGDT benefits long-term outcomes. Data from a 15-year follow-up evaluation of PGDT in high-risk surgical patients revealed that randomization to PGDT was an independent factor in long-term survival.15 In clinical studies, PGDT alone11,16 or in the context of an ERAS program17 has demonstrated decreased LOS of 1 to 2 days.11 One study comparing traditional care with an ERAS protocol in patients undergoing colorectal surgery revealed positive effects of ERAS on several parameters, including LOS.17 A significant difference was observed in LOS between the 2 groups; the median LOS in the ERAS and traditional groups was 5 and 7 days, respectively (P<0.001).17 Hospital LOS reductions were similarly observed during the implementation of the Enhanced Recovery Care Pathway in Britain between 2009 and 2013 and saved an estimated 170,000 bed-days annually.18 Based on the growing evidence supporting PGDT and the need for professional guidance and education, clinical societies have published guidelines for operative fluid management in the United Kingdom,19 France,20 and Europe.21 The European Society of Cardiology/ European Society of Anaesthesiology enhanced recovery guideline cites the utility of specific hemodynamic variables (eg, SVV, PPV, and CO) and the importance of PGDT in reducing postoperative mortality.21

Complications

Supported by Edwards Lifesciences

17

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In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / MAY 2015

Five Factors Seen To Help Guide Treatment Plan for C. Difficile Identifying Patients Who Would Benefit From Surgery B Y M ONICA J. S MITH CHATTANOOGA, TENN.—Clostridium difficilee infection (CDI) has become one of the most common nosocomial infections encountered by the clinician, but the development of treatment guidelines has been hindered by a lack of reliable and widely

accepted severity prediction models. Researchers at the University of Tennessee College of Medicine in Chattanooga, however, have identified five variables that may help develop a clinical prediction tool for guiding treatment decisions in severe cases. “The surgical literature has shown early surgical intervention to lower mortality, but typically the operations in the most severe cases include a total abdominal colectomy, which is a very morbid procedure,”

said Matthew Figh, MD, chief surgery resident at that institution, who presented the group’s results at the Southeastern Surgical Congress. “We would like to identify and isolate the patients who would benefit from this. The ultimate question now is when is a case likely futile? A clinical prediction tool would be very useful in helping to identify those patients.” There are clinical prediction models currently available, but Dr. Figh and his

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‘This will ultimately allow better classification of severity and help surgeons identify patients who would benefit from early surgical intervention.’ —Matthew Figh, MD

colleagues believe they are of little help. “The main issue with them is that they use the ICU admission and surgical intervention as their end points. Since a clinical prediction tool is used to make treatment decisions based on an algorithm, it seems a circular argument to base your end points of that treatment,” he said. “These models are typically better at predicting who will do well, not who will do poorly.” The primary objective of their study was to determine a combination of risk factors that would identify patients most likely to die with surgical intervention. The researchers examined data on 876 patients with CDI between 2003 and 2010, of whom 82 (9.3%) died. They conducted a complete chart review of 274 of those patients, including all deaths. “We looked at 32 variables taken at the time of admission, the time of diagnosis of CDI and 48 hours after CDI diagnosis,” Dr. Figh said. Of those 32 variables, five emerged as being statistically significant and, in combination, predictive of mortality: age greater than 60 years, use of vasopressor agents at time of diagnosis, acute or chronic renal disease at time of diagnosis and albumin less than 3.0 g/dL. “Most of these are actually comorbidities, but our aim was to find risk factors associated with morbidity and mortality,” Dr. Figh said. The five variables “represent an overall deterioration of normal physiology, and they do not exist in a vacuum. We believe it is a combination of these factors [that determines] the overall severity.” Dr. Figh concluded that defining the five variables, easy to identify at bedside, is the first step in his institution’s goal of creating a clinical prediction tool. “This will ultimately allow better classification of severity and help surgeons identify patients who would benefit from early surgical intervention. It will also help us identify patients who would benefit better from medical treatment and avoid the morbidity associated with aggressive treatments like total abdominal colectomy,” he said. Denis W. Ashley, MD, FACS, Milford B. Hatcher Professor and chair of the Department of Surgery at Mercer University School of Medicine in Macon,

Opinion

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / MAY 2015

On Being a Surgeon B Y M ARC N EFF , MD

I

have had the privilege to train many residents in my career so far. Training residents is quite an honor. Recently, I’ve become quite aware of a growing sense of negativity among my residents. Dissatisfaction about their training. About their work hours. About their life sacrifices. About their exposure to critical care, breast care, major pancreatic operations, and the list goes on. Maybe they are feeding off of disgruntlement from their attendings. Maybe they are feeding off of current events and market changes in medicine. Maybe it is partly the expectations of this next generation. Whatever the reason, the sense that the glass is half empty is palpable. Recently, I had a discussion with one such unhappy surgeon in training. He was upset over an unsatisfactory interaction with a nurse. I tried to help him shrug it

Ga., reviewed the study ahead of time. He challenged several points of the statistical analysis, all of which Dr. Figh answered to his satisfaction (e.g., the variables were not taken into groups, each variable was considered independently for its predictive ability; the researchers used a multivariate, not a multivariable logistic regression). However, Dr. Ashley also had a practical, clinical question. “What do we take home from this paper, and how can we use it to manage our patients?” he asked. “If we have a patient over 60, on vasopressors and steroids at the time of diagnosis, what do we do?” Most surgeons, he posited, would classify this type of patient as critically ill and consider surgical intervention expecting a high likelihood of death. “Does this tell us something we don’t already know? Should we continue to look for variables that so far have been elusive that would help us identify patients with a high risk for mortality before they get so sick?” he asked. “Dr. Figh alluded in his presentation that this is a first step, and I would agree with that.” In response, Dr. Figh pointed out that the availability of a prediction tool may help physicians explain treatment options to patients and their families. “In a situation where you have all five of these variables present, being able to give them statistical information as far as expected mortality can help the family come to a better understanding of your treatment suggestions,” he said.

off by changing the subject; it didn’t work. I tried to help reduce the sting by intellectualizing it; didn’t work. I even tried to make a joke, but he still simmered like a pot waiting to boil over. I then went into the following exercise with the resident that I would like to share. You, the surgical resident, will perform operations on roughly 1,000 patients during your training. Maybe another 300 to 500 during a fellowship, if you pursue it. You will then embark on

a surgical career that will last, on average, about 30 years. Each year, conservatively, you will take 400 patients to the operating room. In some parts of the country, more; in some specialties, less; but it’s a good first approximation. Multiply that out, and it’s more than 12,000 major operations performed. Add to that the random abscess, debridements, inoffice procedures, endoscopies and line placements over a 30-year career, and it’s easily 15,000 patients on whom you, the

surgeon, will leave your mark before your career is over. People will have scars on their bodies only because of you, as if you left your fingerprints that you were there. There are few professions that have that type of impact. If the goal, as you said in your medical school interview, was to help people, that’s a heck of a lot of people you will have helped. But, that number is only the beginning. If you continue the math, and add to see BEING A SURGEON page 20

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Opinion

GENERAL SURGERY NEWS / MAY 2015

BEING A SURGEON jContinued from page 19

it the 100 or so residents that you, the average general surgeon, will train in your career if at a teaching institution, you suddenly jump to 1.5 million lives touched (15,000 × 100). Those 15,000 patients per resident taught, as they pursue their 30-year careers, are carrying on your lessons that you passed on. Those teachings will live on long past when you are gone. It is, in a sense, a living message you are sending to a time you will never see. The ripple effect of one becoming a surgeon is far reaching indeed. In a sense, in some small way, you are becoming immortal. I had the resident’s complete attention. But I chose to continue, and press the point further. I went on to explain to the resident that he would make roughly $250,000 a year once he became an attending. In some markets and surgical specialties, more than that; in some, less; but it’s a good estimate. Doing the math again, for a 30-year career, that’s $250,000 × 30 = $8.5 million. In other words, you, the surgical resident, are basically a sports star. You get a contract worth millions of dollars, but instead of your career lasting five years like the average NFL superstar, it lasts 30.

The ripple effect of one becoming a surgeon is far reaching indeed. In a sense, in some small way, you are becoming immortal. In addition, as a surgeon, you are able to find a good-paying job, wherever in the country you might want to live. And you, the surgeon, will always be able to provide for your family. Provided, of course, that you learn to be a good surgeon, and keep your nose clean of malpractice cases, your finances are set for life. So, in summary, a general surgeon can earn millions of dollars, impact millions of

lives, have a bit of immortality, find a job in any part of the country, and always be able to provide for his or her family. The resident had now completely forgotten about the nurse, and was looking a little pale as I acted the fortune teller showing a glimpse of the future. He remarked that no one had ever explained all that to him. I responded by reminding him what other professionals are doing

right now. Training to work as an NFL football player is extremely difficult. The exercises start early in the morning and end late at night. The muscles and mind ache. The training of an Olympic athlete is similarly grueling. To become the best takes work upon work, and then even more work. No one reaches the top of Mount Everest without getting bruises and scrapes, sometimes finding it hard to breathe, and even encountering a Yeti or two. But that’s the price, and the rewards, of reaching the top, of becoming a successful surgeon. So to you, young resident in training, feeling bitter, tired, drained, emotionally, physically and mentally, I say, to become a master craftsman, to have the impact on the world as a master craftsman, embrace what it takes to become the master. Revel in it. Rejoice in it. Recognize the blessing you have been given to have the opportunity to become a master. Let go of the negativity. Let go of whether the glass is half full or half empty, and be happy that you have been given an opportunity to have a glass. —Dr. Nefff is Director of the Bariat— ric Surgery Program, Minimally Invasive and Bariatric Surgeon, Kennedy University Hospital, Cherry Hill, N.J.

In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / MAY 2015

Put Patients’ Families at Ease With EASE, the Communication Smapp B Y P AUL A LAN W ETTER , MD

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lot is happening in the world of scientific and medical apps (smapps). For example, a procedure is delayed or going a little longer than anticipated, and you are concerned about the family in the waiting room and wish you could keep them informed. Familiar scenario? If so, this may be a smapp for you. EASE (Electronic Access to Surgical Events) is an app that allows physicians to communicate with families and loved ones in real time during a surgical procedure, providing reassurance about the patient’s progress. The goal of EASE is to create a secure connection with a patient’s designated recipients and facilitate one-way transmission of medical updates. By sharing the status of patients undergoing medical procedures via texts, photos and videos, concern is reduced and patient satisfaction is increased. EASE is composed of two apps. The first is EASE Sender, which is the app that clinicians use to send the updates to families and friends. The other is EASE Receiver, which is what families use to receive the updates. Both are available for download in the Apple iOS and Android app stores. During a medical procedure, updates are sent via the EASE Sender application. This is usually done by the circulating nurse under the guidance of an attending surgeon or anesthesiologist. The EASE app also allows for the collection of customizable surveys and testimonials. According to EASE Applications, compliance with HIPAA privacy requirements is accomplished by all communications in transmission and in storage using encrypted 256 bit

algorithms. Similar security is provided in servers storing information. The standard setup is to have the message disappear after 45 seconds of viewing. An interesting feature is the capability for the “covered entity,” as EASE calls it, to choose to store secure information for up to six years as an alternative. The “covered entity”— the customer of EASE—is often a hospital, surgery center or surgical practice. During registration, up to 10 family members or friends can be added to the

network of people who will receive EASE updates. Only those people designated by the patient can receive updates. After each EASE session, recipients are sent a survey for hospitals or centers to collect data pertaining to satisfaction and quality improvement. According to EASE Applications, pediatric orthopedic surgeon Jonathan Phillips, MD, at Arnold Palmer Hospital for Children, in Orlando, Fla., reports a significant impact on the waiting process,

including decreases in family anxiety and increased trust: “It can be taken for granted by doctors that the explanation you give families before and after surgery is enough and almost always it is not. This makes my job easier after the surgery is complete.” More smapps next month. —Dr. Wetterr is chairman, Society of — Laparoendoscopic Surgeons. He can be reached at Paul@SLS.org.

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In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / MAY 2015

Chiefs, With Tougher Cases, See More Complications Than Interns B Y P AUL B UFANO

C

hief residents have a higher rate of surgical complications, longer operative times and longer hospital lengths of stay than new residents, according to the results of a study presented at the 2015 Southeastern Surgical Congress. This can be explained by patient acuity and autonomy differences because interns are more likely observing cases

and chief residents are given more autonomy in the operating room, said lead investigator Vedra Augenstein, MD, a general surgeon at Carolinas Medical Center, in Charlotte, N.C. “More senior residents are appropriately participating in surgeries on patients who have increasing numbers of comorbidities, are obese, have preoperative sepsis or require emergent operations,” she said. “The sickest patients receive care by not only an attending

surgeon but also the most senior surgical resident. Although there is no such thing as an ‘intern case,’ this study shows that there is a predilection toward participation in the more difficult operations at the end of one’s training versus at the beginning.” Researchers examined a group of patients who underwent the five most common operations performed by residents during a general surgical residency (according to the Accreditation Council

‘Resident participation in surgery is essential to their training as there is no simulator that can compare to or replace the traditional operative experience as a conduit to mastery of surgery.’ —Vedra Augenstein, MD

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Jan Paul Mulier, MD, PhD Bariatric Anesthesiologist St. Jan’s Hospital Bruges, Belgium

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for Graduate Medical Education): laparoscopic appendectomy, laparoscopic cholecystectomy, open inguinal hernia repair, ventral hernia repair (open and laparoscopic combined) and open partial colectomy. To remove potential variation in the resident population, the investigators compared the same cohort of residents during their intern year (cases they participated in during 2006-2007) and during their chief year (cases they participated in during 2010-2011). They found 15,645 cases (11,144 chief and 4,501 intern). When compared with new residents, chief residents had a higher rate of wound complications (6.0% vs. 2.5%), general complications (16.9% vs. 4.1%), major complications (6.7% vs. 1.9%) and readmission (8.7% vs. 0%), respectively. Furthermore, their cases were 11.5 minutes longer and their patients stayed in the hospital 0.4 days longer. However, chief resident cases had higher rates of sepsis, emergency surgery and multiple comorbidities. Patients in the chief residents’ group were older, had higher body mass index and were more likely to be inpatient (70% vs. 35%) or emergent (23.8% vs. 12.9%). The researchers hypothesized correctly that patients undergoing most common general surgery procedures would have improved outcomes if their surgeries were performed primarily by chiefs rather than interns, said Dr. Augenstein. “This is typical in surgical training given the graduated responsibilities as a resident matures as a surgeon,” she said. “Resident participation in surgery is essential to their training as there is no simulator that can compare to or replace the traditional operative experience as a conduit to mastery of surgery. As far as the next step in this area of research, we would like to compare the surgical outcomes of more traditionally trained residents to those who receive more simulator training during their residency.”

In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / MAY 2015

SURGICAL TRAINING jcontinued from page 1

The other main benefit Dr. Kellogg described before the 2015 Southeastern Surgical Congress was the opportunity to explore the various types of surgical practices—academic, private, hospital employee, group—as well as different practice settings: metropolitan, suburban or rural. “Often if you’re trained in a big academic center, you don’t get exposure to these other settings. I did not receive any rural surgery exposure in my training, but thought I might want to make my career in a rural setting,” he said. “In addition, I saw this year as an opportunity to hone skills in which I lacked expertise.” Dr. Kellogg learned of TTP through R. Philip Burns, MD, FACS, with whom he had consulted about potential career opportunities in the Chattanooga, Tenn., area. Serendipitously, the two encountered each other just on the heels of the meeting of the ACS Board of Regents that approved the program. “Ben asked me if I knew of anyone who needed a practice associate and I said, ‘have I got a deal for you,’” Dr. Burns said.

Justification for the TTP The question of whether residency prepares surgeons for practice is a matter of some debate, but there is widespread concern that the implementation of resident work-hour restrictions in 2003, among other things, had a deleterious effect on the training of general surgeons. “Many of us felt this would ruin general surgery training by not allowing for continuity of care, by not allowing young surgeons to be in the operating room [OR] and take care of their patients,” said Frederick Greene, MD, former chair of surgery and general surgery program director at Carolinas Medical Center School in Charlotte, N.C. “Many of them do pursue fellowships because they don’t feel confident in general surgery.” Multiple sources support this observation. A 10-year summation of a questionnaire about problems in surgery addressed by the ACS Board of Governors showed graduate medical education as being No. 4 on the list and moving to the third spot in the past two years. “It’s been a concern reflected by the governors and fellows for a long time and continues to be so,” said Dr. Burns, chair of the Department of Surgery at the University of Tennessee (UT) College of Medicine in Chattanooga and director of the TTP program at that institution. A survey of surgical educators and fellowship program directors also showed dissatisfaction with graduate medical education. “It indicated that residents are not ready at this point to

operate independently, make decisions, suture and tie laparoscopically, recognize early signs of complications, or function independently in an OR or on call,” Dr. Burns said. “This is very disturbing information.” A 2009 survey of 4,402 general surgery residents reflects this discomfort, showing that about 27% were not comfortable with performing procedures alone, and about 64% felt they needed specialty training to be competitive ( (JAMA 2009;302:1301-1308). “Basically, this showed that a significant percentage of categorical residents in programs did

”I think most of us stand in awe at times of the intellectual ability, background and life experiences many of our residents have. We feel the system is to blame.“ —R. Philip Burns, MD

not think they would be able to function independently and confidently by the time they finished,” Dr. Burns said. So if there is a problem, who is to blame? “I think most of us stand in awe at times of the intellectual ability, background and life experiences many of our residents have. We feel the system is to blame,” Dr. Burns said.

How TTP Came About The TTP is an attempt on behalf of the ACS to address the perceived problem that surgeons are not ready to see SURGICAL TRAINING page 24

WE TAKE PAIN PERSONALLY REASON #1

THE NEED FOR NON-NARCOTIC PAIN MANAGEMENT THERAPY HAS NEVER BEEN GREATER. Hospitals are looking to reduce adverse events and opioid consumption. 1-3 Patients receiving an opioid prescription within 7 days of surgery were 44% more likely to become long-term opioid users within 1 year when compared with those who received no such prescription.4 ON-Q* is proven to reduce the amount of narcotics patients receive after surgery. 5 For more than 16 years, we have been focused on improving patient outcomes. By continuously working together with clinicians to improve catheter placements and block techniques, the ON-Q* Pain Relief System has been able to reduce the amount of narcotics needed to effectively manage post surgical pain—for each patient and procedure.

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PAIN MANAGEMENT YOU CAN DEPEND ON.

1. The Joint Commission. Sentinel Event Alert. A complimentary publication of The Joint Commission. Issue 49, August 2012. 2. Attarian, David E. What is a preventable adverse event? AAOS Now. 2008, May. 3. unknown. (12, December). Lifespan adopts emergency department guidelines created to curb opioid misuse and abuse. Retrieved from http://www.acphospitalist.org/archives/2014/02/coverstoryy.htm. 4. Alam et al. Long-term analgesic use after low-risk surgery: a retrospective study. Arch Intern Med. 2012 Mar 12;172(5):425-30. doi: 10.1001/aarchinternmed.2011.1827. 5. Data on file. ON-Q* Pain Relief System. *Registered Trademark or Trademark of Halyard Health, Inc. or its affiliates. © 2015 HYH. All rights reserved. RX Only. MK-00754 03/2015.

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GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / MAY 2015

SURGICAL TRAINING jcontinued from page 23

practice general surgery after residency, and also to encourage doctors to pursue general surgery rather than a subspecialty. The idea and concepts for the program brewed over several months in 2012, and the program was given the green light from the ACS Board of Regents at its September 2012 meeting. A pilot for the program launched in 2013 at UT College of Medicine and the Mercer School of Medicine in Macon, Ga., and 14 other sites throughout the

country were given preliminary approval by March 2014 to initiate their own TTP programs. Essentially, the TTP program is like a fellowship in general surgery except that it does not adhere to strict fellowship criteria as established by the Accreditation Council for Graduate Medical Education; participants are associates rather than fellows. Stressing that TTP is not a remedial program, Dr. Burns described it as a flexible opportunity for education and the development of autonomy, directed by surgeons through the ACS to encourage residents to pursue a career in

general surgery. Before establishing Dr. Kellogg in the TTP program, Dr. Burns needed to consult with faculty to be sure that the program would not compete with other programs, including a number of fellowships. “A TTP program cannot conflict with your existing general surgery program; you can’t bring in a new graduate and have [him or her] compete for cases,” Dr. Greene said. “That’s not the concept.” He also needed to bear budget in mind. “We had to look at where we were going to get the research and development

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dollars for this,” Dr. Burns said. The curriculum is flexible, but mainly follows its original design of five to six months of monitored practice, in which residents work closely with a faculty member in the OR, outpatient area or on call, followed by six or seven months when the associate works in independent practice, becoming completely autonomous with assistance from those faculty members. A resident’s participation begins with an intake assessment and discussion of the goals of the program, the resident’s professional and personal goals for the year and how the program can help the resident attain those goals. “At my initial intake assessment, we reviewed my case logs from residency to see where I might benefit from some additional training, and also considered where I felt I would benefit from additional training,” Dr. Kellogg said. From this assessment, all parties determined that a significant component of Dr. Kellogg’s program should be based in a rural setting and that he could benefit from additional experience in breast and anorectal surgery, endoscopy and advanced laparoscopic surgery. Additionally, the program took advantage of certain ACS resources to address practice management issues that are crucial to running a practice but tend to receive little attention during residency. For instance, Dr. Kellogg attended a two-week coding and billing workshop at the beginning of his program. “I also attended a practice management seminar conducted by the University of Tennessee, and underwent a curriculum run by the chief executive

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / MAY 2015

“I was well trained in a very good residency program, but when I finished I lacked confidence in my abilities.“ —Benjamin E. Kellogg, MD

officer of the University Surgical Associates’ group to cover business administration over several sessions.” Dr. Kellogg was board-eligible and became board-certified three months into the program, which allowed him to obtain unrestricted privileges at the hospitals where he worked, allowing him to gradually increase his patient care responsibilities and eventually have his own clinic, with back-up supervision when needed. He spent his first few months in the program working in more of an apprenticeship model with general surgeons in clinics, OR and on call, gradually gaining more independence. Dr. Kellogg later had the opportunity to work with Craig Sawfford, MD, at a practice in rural Dayton, Tenn., that is affiliated with the faculty of the UT College of Medicine, Chattanooga. Dr. Kellogg joined the Dayton practice in 2014. Both Drs. Sawfford and Kellogg are assistant professors with the UT College of Medicine. “I was well trained in a very good residency program, but when I finished I lacked confidence in my abilities,” Dr. Kellogg said. “Now that I’ve completed the program and have some perspective, I think the program benefited me best by increasing my autonomy as a surgeon from resident to independent practitioner,” Dr. Kellogg said.

Where the Program Stands Today At this point, more than two years since it started, there are 18 TTP programs across the country and six more pending approval, with 11 associates confirmed for participation this year and possibly as many as 15 starting in July.

Budget, however, is a problem, and some institutions that have initiated a TTP program, including the University of Tennessee in Chattanooga, have opted out or chosen not to run the program consecutive years. “We’ve run two TTP programs now. But we have an adequate number of surgeons, and we don’t have enough of an excess caseload to support the $125,000 to $150,000 it costs to run the program,” Dr. Burns said. The costs include the associate’s salary, plus health insurance, malpractice insurance and incidentals such as travel

to meetings and workshops. Dr. Kellogg was able to generate about $100,000 in revenue through his caseload, but that still left the program $50,000 in the red. “Our faculty is very supportive of the program, but they don’t necessarily want to pay for it out of their own pockets,” Dr. Burns said. “I see this long term as an opportunity for hospitals that want to partner with a general surgeon who wants to do the program in lieu of starting immediately. If we can get half of it paid for, I think we can get enough compensation back in the flex in the system to pay for part of it. But I don’t

In the News want our faculty to have to eat a $50K loss every year.” Of course, no one is suggesting that all surgeons finishing residency need further training. “I have seen, even in recent years, some very good surgical trainees who finish their chief resident year with all the confidence and skill to go into a practice without something like this program,” Dr. Greene said. “What needs to happen is for program directors to identify individuals who they feel are not ready and recommend that they do something like this,” he added.

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GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / MAY 2015

SEPSIS

jcontinued from page 1 and they remain at higher risk for death. The national burden of readmissions among sepsis survivors may approach $3 billion in the United States, based on estimates that approximately 91,300 survivors of sepsis will be readmitted to hospital within 30 days of discharge. “These studies argue convincingly that any construct of severe sepsis as an acute illness that, if survived, has few ongoing issues for patients is incorrect,” James O’Brien, MD, MSc, medical director of quality and patient safety at Riverside Methodist Hospital, Columbus, Ohio, wrote in an editorial in the April edition of the journal Critical Care Medicine (2015;43:906-907). “Instead, hospitalization for severe sepsis should be a trigger for clinicians to identify patients as an at-risk population for new limitations of functional capacity and significant morbidities, such as cognitive dysfunction and ongoing health care utilization.” The studies consistently demonstrate that sepsis patients treated in this country are likely to return to hospital within months. In a research letter published in the March 10 issue of JAMA, investigators reported that 42.6% of people who were treated in the hospital for severe sepsis and then discharged were rehospitalized within 90 days (2015;313:1055-1057). The investigators analyzed data from the U.S. Health and Retirement Study, a sample of households including adults aged at least 50 years that is linked to Medicare claims from 1998 to 2010. They matched almost 2,600 hospitalizations for severe sepsis to hospitalizations for other acute medical conditions. In both groups, 42% of patients were readmitted to hospital within three months. When researchers looked at the reasons for the readmissions, patients who survived sepsis were significantly more likely to be readmitted for a condition that could have been prevented or treated early. In all, nearly 42% of readmissions among sepsis survivors were due to preventable conditions, according to an expanded definition that the team used. Those conditions included a second bout of sepsis, kidney failure, heart failure and other infections. Hallie Prescott, MD, MSc, the lead author of the paper and a critical care physician at the University of Michigan Health System, in Ann Arbor, said these conditions could be managed if patients could see a doctor at the start of their illness. “We need to assess their vulnerability and design a better landing pad for patients when they leave the hospital, and avoid the second hit that derails a

‘For now, vigilance is going to be what we can add to these ICU patients’ care until we have more information.’ —Jose L. Pascual, MD, PhD recovery,” she said. Two recent studies in Critical Care Medicinee also emphasize the need for better discharge care for sepsis patients. One study from investigators at the Medical University of South Carolina used administrative data from California, Florida and New York over a six-month period in 2011, and another study from researchers at the University of Pennsylvania, Philadelphia, described the experience of septic shock survivors at a tertiary, academic hospital (43:729-737; 43:738746). In both reports, a significant percentage of index admissions resulted in death during hospitalization, at 23% and 32%, respectively. Around one-fourth of survivors were readmitted within 30 days of discharge, 23% and 26%. Both studies found that readmissions were often related to the index admission for sepsis instead of a new diagnosis, although there was a significant gap between the two, at 78% and 22%. A fourth study, published in Annals of the American Thoracic Society, found the readmission risk to be 1.51 times greater (95% confidence interval, 1.38-1.66) than non-sepsis hospitalizations, in a comparison of post-acute care use at discharge and hospital readmission after 3,620 sepsis hospitalizations and 108,958 non-sepsis hospitalizations (Ann ( Am Thorac Soc 2015 March 9 [Epub ahead of print]). After controlling for pre-sepsis characteristics, readmissions after sepsis were more likely to result in death or transition to hospice care (6.1% vs. 13.3% after sepsis; P<0.001). Independent risk factors associated with 30-day readmissions after sepsis hospitalizations included age, cancer diagnosis, hospitalizations in the year before the index hospitalization, non-elective index admission type, one or more procedures during the index

hospitalization, and low hemoglobin and high red-cell distribution width at discharge. Jose L. Pascual, MD, PhD, surgical ICU co-medical director at the Hospital of Pennsylvania, Philadelphia, said the past five years mark a significant shift in thinking about sepsis and critical care, with a growing awareness of the difficulties these patients face after they leave the ICU. “We’re just starting to understand that patients are significantly different in terms of post-ICU needs if they are septic patients,” he said. Unfortunately, he noted, there is still little understanding of how to improve ICU and post-ICU care in ways that will reduce the difficulties that survivors face in the months after discharge. “For now, vigilance is going to be what we can add to these ICU patients’ care until we have more information. We may need to really cross the t’s and dot the i’s on the patient who was septic in the ICU to make sure that before discharge, we’ve got the antibiotics, the follow-up cultures and follow-up visits teed up much more vigilantly.” Lewis J. Kaplan, MD, interim chief of surgery and section chief for surgical critical care at the Philadelphia VA Medical Center and associate professor of surgery at the Perelman School of Medicine, University of Pennsylvania, said post-ICU care for septic patients should be considered a national health issue. “This is a national problem rather than one exclusively for individual centers. Severe sepsis and septic shock are labor-intensive, financially costly, and they consume resources. You would expect to have as good an outcome as possible after directing all that toward the patient and their underlying disease

processes. But you see rates of rehospitalization of 26% to 27% after sepsis,” he said. The problem, he pointed out, is that the studies do not answer the question of why patients are readmitted at such high rates. The studies relied on administrative databases, which lack details on discharge regimens, patient compliance with follow-up care and specifics on antibiotic use. Dr. Kaplan called for prospective studies that examine patient care in the outpatient sector. Innovative programs, such as a post-discharge ICU clinic, may be helpful, he said. “Its impact on readmission after ICU care for severe sepsis or septic shock has never been studied, but it would seem, based upon these ICU readmission rates, that there’s a real opportunity and a need for an outpatient intervention like that,” he noted. As the critical care medicine field waits for further research, Dr. O’Brien said surgeons, who often maintain a longer-term relationship with their patients than most intensivists, are more likely to care for sepsis survivors after discharge. “They could help to connect the dots for patients that the post-sepsis symptoms they suffer are real and due to the sepsis, more than the trauma or surgery,” he said. He emphasized the need for robust hand hygiene and judicious use of antibiotics for infections or prophylaxis, rather than noninfectious systemic inflammatory response syndrome. “Sepsis is a major cause of death after surgery and after trauma. Surgical mortality and morbidity would be reduced with rapid identification and treatment of sepsis in postsurgical patients. Preoperative counseling of patients and their families to be partners in avoiding infections in the hospital by ensuring that anyone that touches the patient washes his or her hands first [is recommended],” he said. Editor-in-chief of Critical Care Medicine, Timothy G. Buchman, MD, PhD, wrote an elegant and emotional foreword to the April 2015 issue, describing the immense toll that sepsis takes on patients, their families and friends. He recounts the way his English teacher, who later went on to become executive editor-in-chief at Random House, was pulled out of class to go to his brother who was dying of severe staphylococcal sepsis. “The phone call came, his teacher left, and his life changed. Science and medicine replaced journalism as the goal,” he wrote, speaking about himself. “Half a century later, he’s rescuing septic patients. Writing forewords for Critical Care Medicine. Was he touched by the one case of fatal staphylococcal sepsis? Does he belong on the map?” “You tell me.”

In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / MAY 2015

CT SCANNING jcontinued from page 1

injury, intraabdominal hematoma, hollow viscus injury or any urologic injury. Of the 147 patients evaluated, the mean age was 69 years, and 88% had fallen from standing. A chest CT was obtained in 111 patients (76%), and eight (7%) had significant thoracic injury: four patients had more than three rib fractures, two had PTX and two had HTX. Abdominal CT was obtained in 86 patients (59%), five (6%) of whom had significant abdominal injury: three with solid organ injuries and two with intraabdominal hematomas. “Looking at our thoracic imaging data, we had no patients with thoracic injury on chest CT who did not have complaints of history or pertinent physical exam findings. This was also true with our abdominal imaging data,” Dr. Lavingia said. “In both cases, the history and physical had a negative predictive value of 100%.” All patients without significant injury were discharged to home or to the next level of care with no delay or subsequent complications. No patients were readmitted to the hospital, and there was no notification that any of these patients had returned to an outside hospital with any complications or missed injuries. “On conclusion, a thorough history and physical exam in the trauma bay allows the clinician to obtain selective CT imaging. Routine torso CT imaging warrants re-evaluation in low-impact injury mechanisms as there appears to be little benefit compared with the resource utilization and expense that comes with it,” Dr. Lavingia said, noting that his institution has since implemented a protocol of selective imaging in the trauma bay. Patrick Greiffenstein, MD, a trauma surgeon and assistant professor of clinical surgery at Louisiana State University in New Orleans, commended Dr. Lavingia and his colleagues on their research. “It’s an important study that points out what many of us believe to be the obvious. It is also heartening to know that someone is advocating for reliance on the physical exam and thorough history taking in this era of increasing automation and disengagement from patients.” He did, however, have a couple of questions. “First, if the patients you described were adults with a GCS greater than 13 experiencing groundlevel falls who did not appear to meet any physiologic or anatomic criteria for activation, why were they classified as trauma patients? Also, would you advocate the same treatment in community hospitals? In most [community] emergency departments, the leading physician

‘Routine torso CT imaging warrants re-evaluation in low-impact injury mechanisms as there appears to be little benefit compared with the resource utilization and expense that comes with it.’ —Kedar Lavingia, MD has little or no trauma experience and is often unable to perform the fast examination that, in your study, seemed essential for picking up occult thoracic or abdominal pathology.”

Dr. Lavingia responded, “We routinely get these patients transferred as trauma patients from outside hospitals because many community hospitals are not comfortable

taking care of, for example, an 80-year-old patient with a rib fracture.” He went on to say that he did not advocate applying the same diagnostic criteria in community settings. “I think we do a good job using the ultrasound to pick up thoracic and abdominal pathology, but I don’t think the same level of training is used in our outside areas.”

IMPORTANT CORRECTION OF DRUG INFORMATION ABOUT EXPAREL® (BUPIVACAINE LIPOSOME INJECTABLE SUSPENSION)

from the US Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) on September 22, 2014 concerning an advertisement for EXPAREL, which you may have seen published in several professional journals. This publication provides important corrective information about the false and misleading claim. The FDA stated that the advertisement was false or misleading because it overstates the efficacy of EXPAREL. The FDA objected to the claims that EXPAREL provides pain control that lasts for up to 72 hours because the claims suggest that EXPAREL has been shown to provide pain control beyond 24 hours. According to the Prescribing Information, “The primary outcome measure was the AUC [area under the curve] of the NRS [numeric rating scale] pain score (cumulative pain scores) collected over the first 72 hour period.…In this clinical study, EXPAREL demonstrated a significant reduction in pain intensity compared to placebo for up to 24 hours. The difference in mean pain intensity between treatment groups occurred only during the first 24 hours following study drug administration. Between 24 and 72 hours after study drug administration, there was minimal to no difference between EXPAREL and placebo treatments on mean pain intensity.” Excerpts from the applicable sections of the FDAapproved package insert for EXPAREL follow. The FDA has reviewed and approved this communication. Indication for EXPAREL EXPAREL is a liposome injection of bupivacaine, an amide-type local anesthetic, indicated for administration into the surgical site to produce postsurgical analgesia. EXPAREL has not been studied for use in patients younger than 18 years of age. Clinical Studies Hemorrhoidectomy The primary outcome measure was the AUC of the NRS pain intensity scores (cumulative pain scores) collected over the first 72 hour period. There was a significant treatment effect for EXPAREL compared to placebo. ©2015 Pacira Pharmaceuticals, Inc. Parsippany, NJ 07054 PP-EX-US-0623

2/15

In this clinical study, EXPAREL demonstrated a significant reduction in pain intensity compared to placebo for up to 24 hours. The difference in mean pain intensity between treatment groups occurred only during the first 24 hours following study drug administration. Between 24 and 72 hours after study drug administration, there was minimal to no difference between EXPAREL and placebo treatments on mean pain intensity; however, there was an attendant decrease in opioid consumption, the clinical benefit of which was not demonstrated. Important Safety Information EXPAREL is contraindicated in obstetrical paracervical block anesthesia. EXPAREL has not been studied for use in patients younger than 18 years of age. Non-bupivacaine-based local anesthetics, including lidocaine, may cause an immediate release of bupivacaine from EXPAREL if administered together locally. The administration of EXPAREL may follow the administration of lidocaine after a delay of 20 minutes or more. Other formulations of bupivacaine should not be administered within 96 hours following administration of EXPAREL. Monitoring of cardiovascular and neurological status, as well as vital signs should be performed during and after injection of EXPAREL as with other local anesthetic products. Because amide-type local anesthetics, such as bupivacaine, are metabolized by the liver, EXPAREL should be used cautiously in patients with hepatic disease. Patients with severe hepatic disease, because of their inability to metabolize local anesthetics normally, are at greater risk of developing toxic plasma concentrations. In clinical trials, the most common adverse reactions (incidence ≥10%) following EXPAREL administration were nausea, constipation, and vomiting. Reporting Adverse Events Heath care providers and patients are encouraged to report adverse events in patients taking EXPAREL to Pacira at 1-855-793-9727. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. Please see accompanying brief summary of Prescribing Information.

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Opinion PATIENT-CENTERED jcontinued from page 1

the $700 billion yearly waste in the U.S. health care system is spent, was a pivotal document for the lawmakers writing the Accountable Care Act (ACA). It is a must-read document for every physician who feels that we are subjected to an outside intrusion into the sacred physician–patient relationship (http://www. ncrponline.org/PDFs/2009/Thomson_ Reuters_White_Paper_on_Healthcare_ Waste.pdf ). When it comes to surgery, it is all about

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / MAY 2015

the 30% unnecessary procedures and how to improve on that ominous number; and yes, it is 30%! The first response by the system trying to reduce the excess and cost was to reduce reimbursement, but that led to more operative procedures and unnecessary care, since we all have heard and used the statement, “you now have to see more patients and work harder to make the same money!” Every single dollar spent in health care follows an “encounter,” which ends with a physician “order” and the cost related to the treatment prescribed, and this is where the 30% excess cost is generated.

That certainly does not mean that 30% of physicians’ recommendations are selfserving, and a deeper look into how we physicians handle decision making and how we communicate it to patients explains how the problem is caused, and proposes a natural solution. This solution is embodied by the new buzzword, “patient-centric medicine.” As the old saying goes: “In the eyes of the carpenter whose only tool is a hammer, the whole world looks like a nail.” For many medical conditions for which there is more than one medically accepted treatment option, the medical

literature is inconclusive or physicians disagree about which option is better. These conditions are referred to as “preference-sensitive” and include the care of nonemergent heart conditions, spine and joint surgery, many cancer treatments, cesarean delivery and many vascular surgical conditions. In a physician-centric model, we physicians are trained to decide for the patient. That decision is filtered by the bias and experience of the doctor, his medical community allegiances and, obviously, financial interests. The hallmarks of preference-sensitive care are geographic variation and a trend that favors the expensive treatments. As an example, a patient with a heart condition could be twice more likely to get open-heart surgery in one city or four times more likely to get a coronary stent in another, while he is unlikely to be informed that medical therapy could be as effective as both for his condition. What is obvious is that the physician making the decision is more likely to pick an option that works for him or her rather than one that fits with the personal choice and values of the patient, as long as both are defensible and within the “standard of care.” As a matter of fact, the Cochrane review of decision aid support suggests that providing the patient with decision support tools, such as pamphlets or videos, leads to significantly less elective operations with higher patient satisfaction with the decisionmaking process and care, and no worsening of outcomes (Cochrane Database Syst Rev v 2014 Jan 28;1:CD001431. doi: 10.1002/14651858.CD001431.pub4.). The conclusion is that educating the patient will lead to a happier, more satisfied one, a patient who will also cost us less to attend to. The ACA thus mandates that we implement “shared EXP-AP-0020-201301

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / MAY 2015

The carrot is the fact that if you engage in patient education that leads to fewer operations, you will get paid more for the operations that you do.

decision-making,” which translates into the process of informing the patient about the existence of a choice, and rather than choosing for him, providing him with the tools to make that choice. Unfortunately, the acceptance of this change in paradigm has been slow in the medical community and more needs to be done (N Engl J Medd 2013;368:6-8). Although the ACA tells us where we need to be, it is not clear about how we should go there. Why would a surgeon want to engage in shared decision making, a process that costs time and resources and can lead to fewer operations? Where is the carrot? The carrot is the fact that if you engage in patient education that leads to fewer operations, you will get paid more for the operations that you do, and this is how it works: Your patient is now given surveys that measure his experience in his visits with you. The most commonly used family of surveys, the Consumer Assessment of Health Providers and Systems (CAHPS), asks patients questions about whether you provided them with educational material, gave them time to ask questions, listened to them, made them feel you were in a hurry, and other questions about your practice such as waiting time, staff professionalism and others. The responses to these surveys, now used routinely by payors, will place you in a tier according to your patients’ aggregate experience. These tiers are the main tool that your organization or you have to negotiate payments, and the higher your patient experience score is, the more you get paid to do what you do. A close look at the CAHPS survey should make every surgeon aware of what questions his patients will answer about him in the week or two following the visit, and should help him position his

approach and that of his staff to improve patient experience, and thus the revenue of the practice (https://cahps.ahrq.gov/ surveys-guidance/survey4.0-docs/surgical_eng.pdf ). While the implementation of shared decision making could potentially be seen as a factor that may slow down the flow of patients in a certain day, providing patients with educational material that they can go over at home could actually shorten the visits and make these visits more productive for both the physician and his now informed patient. In conclusion, you now are as good as

Opinion

your patient’s health education is, and if you can figure out how to do it right in the new world of patient-centric medicine, you could actually make more money by working less! —Dr. Eid, a vascular surgeon from — Fall River, Mass., is founder and chief of the Center for Vascular Diseases in PrimaCare, a large multispecialty group in Massachusetts and Rhode Island, and founder and chief medical officer of Expert Medical Navigation, a software company that supports shared decision making and patient engagement.

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Opinion

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / MAY 2015

Revise Conventions of Breast Imaging To Put Patients First! B Y S TEVEN V OGL , MD

I

was appalled to learn at the 2014 San Antonio Breast Cancer Symposium that some breast imagers routinely defer diagnostic biopsies for women with positive ultrasounds for days or even weeks. There usually is no good medical reason for this, and it undoubtedly produces days of unnecessary anxiety and fear, since only about one in 10 to 20 women referred for biopsy based on ultrasound findings will have a biopsy that is positive for cancer, at least among those with negative mammograms. Deferring biopsies by weeks when the true-positive rate is so low is an unacceptable burden on these women! The subject came up in a presentation by Jean Weigert, MD, a diagnostic radiologist at the Hospital of Central Connecticut, in New Britain, who reported the local experience with ultrasounds mandated by state law for women with dense breasts, who as a group are at increased risk for breast cancer, but for whom mammograms are often difficult to interpret. The quickest and easiest way to biopsy a breast lesion is to locate it under ultrasound and to use ultrasound to guide positioning of the biopsy needle. The process takes just a few minutes, and the tissue generally is available for interpretation the next day. Indeed, for lesions first visualized by mammography or magnetic resonance imaging (MRI), most radiologists will try to find them on ultrasound to allow application of this simple, quick, inexpensive and efficient technique. An informal survey of breast imaging centers in the New York metropolitan area indicates that some centers routinely offer same-day biopsies when they can, whereas others routinely make patients wait two weeks. Some patients prefer to defer the biopsy, and I see no reason to coerce them into a rushed biopsy they do not want as long as diagnosis of obviously malignant lesions is not deferred by more than two weeks. However, for those who do want prompt biopsy, it should be made routinely available. American College of Radiology Imaging Network studies, as cited by Dr. Weigert, show that adding ultrasound to negative mammograms detects another 4.2 cases of breast cancer per 1,000 women per year, 90% of which are in situ or stage 1. Ultrasound always has seemed attractive to me—why not use a technique that makes immediate biopsy easier for any detected, suspicious lesion. Some biopsy procedures, such as

stereotactic biopsy of lesions visualized only on mammography, needle localization of mammographically identified lesions, and MRI-guided biopsies, are sufficiently complex to justify some delay in their scheduling—ultrasound-guided biopsy is not!

Requires Standby Capacity That Will Not Always Be Used It seems, however, that the economics of the imaging industry have intervened and led to a process by which the woman is told a suspicious lesion exists, but that she will have to return days later to have it sampled. The excuse given is that breast imaging centers are too busy, and have insufficient staff, space and funds to maintain a capacity to perform immediate or same-day biopsies. Although these statements undoubtedly have a seed of truth, these same imaging centers have not been too short of funds to first buy digital mammogram equipment, then spend millions of dollars on MRI machines and the magnetically shielded buildings needed to house them, then localization equipment for MRI-guided biopsies, then tomosynthesis equipment.

Breast Imagers Should Compete on Service, not Hardware Our problem is that breast imaging facilities have been allowed, even encouraged, to compete based on ever more complex and expensive imaging hardware, rather than on patient service. I predict that if we can induce one major imaging center in a given marketing area to advertise that it routinely offers same-day biopsies for positive ultrasound exams, all the other centers in the area will feel obligated to offer this service to avoid losing business. They should have offered this service from the first. The data underpinning breast imaging for cancer detection are considered shaky by many and largely refer to film mammography preventing deaths attributed to breast cancer ((JAMA Intern Med 2014;174:448-454). It is fairly clear that newer imaging techniques find more cancers. Although finding the extra cancers gratifies the radiologist and offers business to the surgeon, radiotherapist and medical oncologist, there is no evidence from prospective comparative trials that newer techniques prevent more breast cancer deaths (the end point used in the past for mammography studies). Indeed, the appropriate end point would be a reduction in all-cause mortality among women randomized to screening. The necessary studies to search for reduction in all-cause mortality would be very large, very expensive and very long,

so such studies have not been undertaken. The point of this article is not that the United States does a lot of breast imaging based on “shaky science” and inappropriate end points, but that the least we can do for the woman who chooses to have this imaging is to get her through it in the minimum time possible with the least anxiety and disruption to her life that we can manage.

How Much Is Needed For Same-Day Biopsies? What resources would be required to do same-day biopsies? A local center in Westchester, N.Y., with two radiologists interpreting breast imaging studies, averages six biopsies per day, with a lot of variation between busy and quiet periods. Between cleaning the room and sterile preparations and a “time out” to make sure the correct breast is undergoing biopsy in the correct patient, the chief radiologist estimates it takes 45 minutes to perform a single ultrasound-guided biopsy. To make this center able to offer same-day biopsies, probably 90 minutes of room time and staffing would have to be set aside, although this would not always guarantee that a biopsy could be offered the same day as it is recommended. Of course, on some quiet days, the time set aside would be wasted. Another center in New York City routinely does four to seven biopsies per day, but can do up to nine if needed. Delay of more than one day is rare at this center, unless the patient prefers to defer the biopsy.

Insurance Issues: A Snag That Can Be Overcome Some insurance companies want to review and examine the ultrasound report before approving an ultrasound-guided biopsy. This seems silly—all such reports will state that the patient has a suspicious lesion that warrants biopsy. One solution would be for the initial ultrasound request to state “ultrasound with biopsy if indicated” and to have insurance companies routinely accept this order. It is absurd to think a company would approve of a cancer screening test and then refuse to allow a simple needle biopsy to establish the presence or likely absence of a cancer. Some payors will not pay for a mammogram if a biopsy is done on the same day! Such policies are a disservice to patients and should be forbidden by state insurance regulators. Advocates should publicize these policies—I doubt they would stand the light of day. They are part of an insurance trick: “Make the provider inconvenience the patient if he wants to be paid in full for his services.” These are the tricks that make patients and providers hate insurance companies.

Source: Indian J Radiol Imaging. 2009;19(3):242-247.

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Some centers believe the radiologist must obtain a prescription from the ordering physician to proceed with the biopsy, fearing citation for “self-referral,” and that insurance will not pay unless an outside ordering physician is requesting the biopsy. Because ordering physicians often fail to quickly return phone calls, this can result in days of delay. Some radiologists will not perform elective biopsies if the patient has taken aspirin, nonsteroidal anti-inflammatory drugs or antiplatelet drugs in the recent past. On the other hand, it is a rare referring physician who would deny a request for an ultrasound-guided biopsy if the radiologist (who, after all, is the expert) recommends it, and especially if it can be done within a few hours. There is no current difficulty regarding self-referral when the radiology department calls the patient back for an annual screening. This issue should be easily addressed with minor regulatory changes. The decision to recommend immediate needle biopsy obviously should be with the radiologist who discovers the suspicious lesion. The insurance coverage and regulatory issues should be resolved easily with suitable public, advocate, press, state insurance department, and legislative pressure.

Same-Day Biopsies May Decrease Prophylactic Mastectomies The anxiety and difficulty associated with breast imaging and biopsy procedures has contributed to the current epidemic of prophylactic mastectomies among relatively low-risk women in the United States. While making ultrasound-guided biopsies and their results more quickly available is not likely to prevent any deaths from breast cancer, it may well decrease the number of needless mastectomies of breasts without serious disease by streamlining the process of breast lesion evaluation. Compared with the capital and labor costs of prophylactic mastectomy and reconstruction, the facility and staffing costs for same-day ultrasound-guided biopsies are a real bargain for society! Same-day biopsies also are a compassionate and moral imperative. —Dr. Vogl is an oncologist from the Bronx, NY.

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / MAY 2015

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