July 2014

GENERALSURGERYNEWS.COM

July/August 2014 • Volume 41 • Number 7

The Independent Monthly Newspaper for the General Surgeon

Opinion

VTE May Be Misleading Quality Measure

Love: Its Real Effect On Patient Care

Hospitals Can Be Penalized Unfairly for Greater Vigilance

B Y B RUCE R AMSHAW , MD ‘Vulnerability is not weakness.

Vulnerability is the most accurate measure of courage.

Vulnerability is the birthplace of innovation, creativity and change.’

—Brene Brown, PhD, LMSW, The Gifts of Imperfection

M

rs. George (not her real name) was not unlike many patients we see for complex abdominal wall problems.

Several years earlier, she had an open abdominal vascular procedure and developed an enlarging incisional hernia. She recounts that when she complained to her primary r care physician and her surgeon, she was told she was getting fat and there was nothing wrong with her abdominal wall.

Eventually, she became angry because her physicians simply were not listening to her. After a while, she sought a second opinion, and that surgeon told her she had an incisional hernia. Due to its size,

B Y C HRISTINA F RANGOU Trainees perform simulated case at the Israel Center for Medical Simulation.

environment may contribute strongly to a patient’s surgical decisions.

Andrea Covelli, MD, a general surgery resident at the University of

key measure used by the Centers for Medicare & Medicaid Services (CMS) to assess a hospital’s quality performance may not reflect quality at all, according to a new report.

Instead, a hospital’s rate of venous thromboembolism (VTE) events directly reflects how frequently the hospital conducts imaging tests to diagnose VTEs. In other words, the more a hospital looks, the more it finds.

“Hospitals may be unfairly deemed a poor performer for the outcome VTE measure if they have increased vigilance for VTE by performing more VTE imaging studies,” said study author Mila H. Ju, MD, MS, a clinical scholar with the American College of Surgeons (ACS) and a vascular surgery resident at Northwestern University, Chicago, after presenting the study at the 134th Annual Meeting of the American Surgical Association.

VTE is a controversial quality-ofcare measure included in many quality improvement programs and public reporting initiatives. The CMS deemed VTE a “never event” that will not be additionally reimbursed after certain operations. Beginning in 2015, VTE occurrence will be tied to financial

see MASTECTOMY page 11

see VENOUS THROMBOEMBOLISM page 13

Physician Stresses Simulation To Avert Harm to Real Patients Physicians Should Be Selected on Skills Outside of Cognition B Y C HRISTINA F RANGOU SALT LAKE CITYY—As a young combat pilot in the Israeli Air Force, Amitai Ziv practiced on a simulator for every nightmare scenario his trainers could come up with: ejecting from

airplanes, landing planes overcome with flames, managing all sorts of equipment malfunctions.

When he started medical school see SIMULATORS page 14

Practice Environment Affects Patient Decisions on Mastectomy Study Shows Contrasts Between United States and Canada

see LOVE page 16

B Y M ONICA J. S MITH

New Product RF Assure Detection System see pages p g 6 and 9

LAS VEGAS—The rapid growth of prophylactic mastectomy has been quite a puzzler in an era that favors increasingly minimal operations. Recent research suggests a surgeon’s practice

INSIDE Opinion

3

Reflections on the VA scandal, by Frederick Greene, MD

Web Exclusive

The Visit generalsurgerynews.com (top right of homepage) to read A blog by Victoria Stern a blog that tackles such issues as: Nature vs Nuture: What Makes an Expert Surgeon?

Work Hour Restrictions: Are New Surgeons Ready for Practice?

Scope

A

GSN Editorial

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / JULY/AUGUST 2014

Reflections on the VA

As a former chief of surgical servic-

Frederick L. Greene, MD, FACS es in the VA system, I weathered the Clinical Professor of Surgery UNC School of Medicine Chapel Hill, North Carolina

W

ith many mixed emotions, I have followed the trials and tribulations of the Veterans Administration health system over the past year.

Following the scandal uncovered at the Veterans Administration Medical Center (VAMC) in Phoenix and the Office of Inspector General’s report condemning approximately 40 other VAMCs for scheduling issues, the story recently reached a fever pitch, highlighted by the resignation of the Cabinet official responsible for VAMC activities.

This is a particularly sad story for me.

As a Navy veteran, I am angry over the way fellow veterans have been treated as clinic wait times were manipulated, fudged and misrepresented by VA underlings and administrators who apparently benefited economically by reporting erroneous wait times for patients. We have yet to hear the full and devastating fallout from this heinous activity.

heated discussion in the late 1980s and early 1990s regarding lack of quality in the VA’s surgical services. This critique did have a positive outcome and led to a full discussion of the importance of risk adjustment of surgical patients and the launch of the VA National Surgical Quality Improvement Program (NSQIP), now called VASQIP in the VA system. This quality initiative, which began in VA hospitals, currently permeates many hundreds of non-VA facilities under the leadership of the American College of Surgeons. Unfortunately, this important positive program launched in VA facilities by surgeons is now overshadowed by all the negative discussion regarding falsification of wait times and the unfortunate outcomes that have have resulted.

Probably the greatest emotion and visceral response for me emanates from the most important aspect of my VA involvement. A significant part of my surgical training took place in a VAMC. My very first rotation as a surgical intern was at the West Haven VA hospital, in Connecticut. Throughout my years as

a surgical trainee, the VA provided me with predominantly positive experiences.

Attendings assigned to the VA were some of the best in my academic medical center and were dedicated to giving optimal care to every veteran.

In all of the discussion regarding the fallout of the recent scandal in the VA system, I have seen nothing regarding the effect on the many medical students, residents and fellows who receive training annually in VA medical centers. I wonder what these young men and women are thinking; I wonder what their program directors and designated institution officials are thinking. One of the positive outcomes that might derive from the current VA illness is to encourage teaching institutions that are involved in collaborative education programs with VA medical centers to take a more handson role. Training programs cannot allow their trainees to work in institutions and be exposed to practices that are antithetical to good patient care. Young physicians rotating through VA hospitals—or any health care institution, for that matter—should be educated in system-related core competencies enabling them to recognize and report inappropriate care when they see it.

I am hopeful that good things will

come from the latest VA debacle, just as NSQIP (VASQIP) was born out of the surgical quality concerns of the 1980s and 1990s. Whatever dialogue ensues regarding issues of poor care, let us not forget an important fallout of these unfortunate events—the effect on our trainees in the VA system. The VA system is desperate for more physicians to work at its hospitals. The 150 VA hospitals and more than 800 outpatient VA clinics are struggling to care for the approximately 9 million veterans enrolled in VA health care (N Engl J Medd 2014 June 14. [Epub ahead of print]). The system must clean up its problems so that young physicians will seek employment in VA facilities and find real satisfaction in taking care of our ever-growing veteran population.

There is no better time to reflect on the role of teaching a new generation of physicians than this month when many residents will begin their training in parent institutions closely associated with VA medical centers. There is no better time than now for the VA health care system to commit itself to excellence for both the veterans it cares for and the physicians it trains. Our VA hospitals must be examples of excellence in every respect; the training needs of young physicians demand it.

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Senior Medical Adviser

Michael Goldfarb, MD

J. Barry McKernan, MD

Frederick L. Greene, MD

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Marietta, GA

Charlotte, NC

Leo A. Gordon, MD

Joseph B. Petelin, MD

Los Angeles, CA

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Gary Hoffman, MD

Richard Peterson, MD

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Namir Katkhouda, MD

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Editorial Advisory Board Maurice E. Arregui, MD Indianapolis, IN

Kay Ball, RN, CNOR, FAAN Lewis Center, OH

Philip S. Barie, MD, MBA New York, NY

L.D. Britt, MD, MPH Norfolk, VA

David Earle, MD Springfield, MA

James Forrest Calland, MD Philadelphia, PA

Edward Felix, MD Fresno, CA

Robert J. Fitzgibbons Jr., MD Omaha, NE

David R. Flum, MD, MPH Seattle, WA

Lauren A. Kosinski, MD Milwaukee, WI

Editorial Staff

Raymond J. Lanzafame, MD, MBA

Kevin Horty Group Publication Editor khorty@mcmahonmed.com

Rochester, NY

Timothy Lepore, MD Nantucket, MA

John Maa, MD San Francisco, CA

Gerald Marks, MD Wynnewood, PA

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Opinion

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / JULY/AUGUST 2014

Specimen Extraction After Lap Sleeve Gastrectomy: Simple Is Better How We Do It B Y M ARIUS L. C ALIN , MD, J OHN C. K OLLAR , DO V ADIM G RITSUS , MD

AND

O

besity surgery is one of the most popular subjects in the current surgical era. Laparoscopic gastric sleeve (LGS) resection has become one of the main procedures in the bariatric surgery armamentarium. The minimally invasive approach is a must in this field, and attention has been focused on using the smallest trocars possible. Efforts are being made to decrease the number and size of the trocars, but there are some technical limitations of the size of the stapler devices that still require a 12-mm trocar. The other concern is that the specimen extraction can be challenging and time consuming when done through a smaller trocar site.

In this article, we present our approach for stomach extraction during LSG. This involves using scissors to cut the specimen in the peritoneal cavity and extracting it in one piece through one of the 12-mm trocars.

We used this approach in 49 of 182 LSG patients without any postoperative intraabdominal abscess, wound infection, staple-line hematoma or leak, or trocar site hernia. There were no reoperations and no mortalities.

The discomfort at the 12-mm trocar extraction site was well tolerated by the patients. Our approach for specimen extraction after LSG resection is safe, feasible and inexpensive and can be done quickly. Our technique has produced good cosmetic outcomes and is easily reproducible.

To date, multiple techniques have been described for removal of the gastric specimen: use of a retrieval bag with or without trocar site enlargement, simple extraction through 15-mm trocar,1-3 use of the morcellator4 or transgastric transoral extraction.5 One study included 25 patients in whom extraction of the specimen was performed through a 12-mm trocar. However, the study authors did not provide technical details about how this was accomplished.6 We present a simple and cost-effective method of extraction of the resected part of the stomach via a 12-mm trocar.

Figure 1. Cutting the specimen along the staple line through both walls.

Figure 2. Specimen is cut along the staple line to create a narrow strip.

Our Approach As part of an observational study, we used the following approach in our group of 49 LSG patients.

After the LSG is completed, the stomach remnant is oriented in the cranial-caudal position in the peritoneal cavity. The stomach is then opened with endoshears at one end and the contents are suctioned.

Usually there are minimal gastric contents present as the stomach normally is suctioned before a gastrectomy is performed. The process continues by cutting longitudinally along the staple line first through both walls (anterior and posterior) of the stomach with endoshears as this is the thickest component of the specimen. In this step, both the staple line and buttress material are cut off from the rest of the specimen and this initial “strip” of stomach tissue is extracted through a 12-mm trocar without having to remove the trocar from the abdominal wall. Then, the stomach wall is cut longitudinally through one wall, but in a zigzag fashion using the endoscissors with the aim to create “strips” no more than 2 cm in width, until the entire stomach becomes a long narrow strip. These steps all take place inside the peritoneal cavity at the end of the procedure, and ultimately the specimen is

Figure 3. Cutting the specimen along gastric wall in zigzag.

Figure 4. Extraction starting with the staple line first.

removed through the 12-mm trocar, not the trocar site, in one piece (Figures 1-7).

The trocar stays in place the entire time so there is no contact between the stomach and the subcutaneous fat. We do not close the fascia for the 12-mm trocar fascia defect made with a bladeless trocar. After removal of the specimen, the area of omentum and small bowel exposed to the gastric mucosa is irrigated with saline and suctioned.

This is a retrospective observational study of 182 LSG patients operated between January 2012 and February 2014. The new approach described in this article for extracting the specimen was used in 49

patients (26.92%). In 133 patients (73.07%), the specimen was extracted intact through a 15-mm trocar site with subsequent closure of the fascia. All the procedures were performed by the same surgeon.

Our Results Neither group of patients reported postoperative intra-abscess formation, wound infection, staple-line hematoma or leak, trocar site hernia, or reoperations.

There were no mortalities. One patient received a blood transfusion due to trocar site bleeding, which was not see SLEEVE GASTRECTOMY page 6

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Opinion

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / JULY/AUGUST 2014

SLEEVE GASTRECTOMY jcontinued from page 4

the site used for extraction of the specimen. All patients were discharged home on postoperative day 1 or 2 and gradually returned to their baseline activities. The patients were followed in a clinic according to the guidelines from the American Society of Metabolic and Bariatric Surgery Center of Excellence.

Although pain level was not quantified and no statistical analysis was performed, we observed that patients who had surgery with the new extraction

technique generally had less postoperative discomfort than those who underwent surgery with the older approach.

In the new technique group, none of the patients complained of more postoperative pain or discomfort at the 12-mm extraction trocar sites compared with the rest of the trocar sites, including the 5- and 12-mm trocars. In the second group, all of the patients complained of various degrees of pain at the 15-mm trocar site, with some patients reporting the pain as incapacitating. All of the patients in the 15-mm trocar group said the pain at extraction site was Figure 5. Extraction of the specimen through the trocar outside view. significantly worse, lasted longer and was more bothersome than the discomfort they had at the other trocar sites.

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We believe there are a several advantages to the new extraction technique in addition to it being easily reproducible and less expensive. Parietal wall trauma and excessive stretching of the trocar sites can be avoided, reducing the risks related to trocar-site trauma complications such as hernia, pain or infection.

Removal of the specimen through the 12-mm trocar that stays in place during the procedure avoids direct contact of the stomach mucosa with the subcutaneous tissue, reducing the risk for surgical site infection. There is also no need for additional equipment such as morcellator or endobag.

In our experience, the average duration of the extraction process was about three minutes, which we believe is acceptable compared with the additional time needed to close an extended incision or with a difficult extraction by stretching a 15-mm trocar site.

We also must mention that one of the reasons we began performing specimen extraction using this procedure was patient dissatisfaction due to pain at the trocar site when the enlarged 15-mm trocar site with subsequent fascia closure was used. In our experience, simple extraction through a 15-mm trocar site can be difficult when the resected stomach specimen has a larger volume.

Conclusion Our approach for specimen extraction after LSG has proven to be safe, feasible and inexpensive, and can be done quickly; it has shown good cosmetic outcomes and is easily reproducible. The most important aspect is patient satisfaction and acceptance related to less postoperative pain and discomfort at the extraction site. Although we do not have a comparative group to statistically

Opinion p

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / JULY/AUGUST 2014

Figure 7. Drawing of the cutting directions of the specimen.

Figure 6. Specimen after extraction. prove the efficiency, the outcomes of the patients on whom we have operated so far have given us the confidence to use it routinely in our practice.

References 1. 1. Casella G, Soricelli E, Fantini A, et al. A time-saving technique for specimen extraction in sleeve gastrectomy. World J Surg. 2010;34(4):765-767.

2. 2. Csendes A. A time-saving technique for specimen extraction in sleeve gastrectomy. World J Surg. 2011;35(4):924; author reply 925.

3. 3. Alley JB, Fenton SJ, Peterson RM. The “tip-stitch:” a time-saving technique for specimen extraction in sleeve gastrectomy. Obes Surg. 2009;19(7):926-927.

4. 4. Mahmood A, Silbergleit A. The utilization of a morcellator during laparoscopic sleeve gastrectomy. Technol Health Care. 2006;14(6):537-539.

5. 5. Dotai T, Coker AM, Antozzi L, et al.

Transgastric large-organ extraction: the initial human experience. Surg Endosc.

2013;27(2):394-399.

6. 6. Arru L, Azagra JS, Goergen M, et al.

Three-port laparoscopic sleeve gastrectomy: feasibility and short outcomes in 25 consecutives super-obese patients. Cir Esp. 2013;91(5):294-300.

Disclosure The authors declared that they have no relevant financial conflicts of interest.

—Dr. Calin is from the General Sur— gery Department, Bronx Lebanon Hospital, Bronx, New York; Drs. Kollar and Gritsus are from the General Surgery Department, Valley Hospital, Ridgewood, New Jersey.

See page 8 for expert commentary on this article.

Do you have a clinical pearl to share?

Send your article to khorty@mcmahonmed.com to have it considered for publication.

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Opinion

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / JULY/AUGUST 2014

Expert Commentary Edward Felix, MD Medical Director, Clovis Community Bariatric Program, Clovis, Calif.

I will start by complementing the authors on trying such a bold approach to specimen retrieval. The objective was to safely remove an oversized specimen and reduce the morbidity of the extraction. The technique they described was to fillet the stomach into a spiral strip so that it could easily be extracted through the 12-mm trocar used for stapling. They demonstrated it was safe to cut open the excluded stomach in the abdomen without the use of an extraction bag and not cause infections. They successfully outlined the steps required to achieve this end, but was this elaborate process really necessary to reduce postoperative pain (the goal of the study)?

The increased pain of a 15-mm trocar compared with a 12-mm is caused by closure of the fascial defect. Although it is convention to close defects larger than 10 mm, it has been well demonstrated in bariatric patients that not closing the defects of 12-mm bladeless trocars does not result in trocar hernias. The surgeons, however, did feel it was necessary to close the 15-mm trocar incision to prevent a trocar hernia.

This was appropriate because of the placement of the 15-mm trocar.

A simpler way to resolve the problem is one that we

have used in our sleeve resections. When the 15-mm trocar is placed left subcostal after the abdomen is insufflated, the fascial defect will be at or above the costal margin when the trocar is removed. We have been using this approach for several years and have not seen any significant incidence of trocar hernias.

The specimen tip is brought up into the 15-mm trocar using a claw grasper. The specimen tip and trocar are removed as a unit to prevent the specimen from being stuck in the wound. If the stomach remnant cannot be shimmied out of the defect without opening it, the specimen tip is opened outside the abdomen.

The stomach contents are aspirated to prevent rupture of the specimen and spillage. The stomach remnant is gradually extracted. Only rarely does the fascia need to be stretched or cut. When the abdominal gas is removed, the 15-mm defect collapses and retracts above the rib margin preventing the formation of a hernia. Because the defect is not closed, pain and morbidity of the larger trocar is identical to smaller ones.

It is true that the skin incision is 2 mm larger, but this does not seem to make a cosmetic difference. The key to this quick and simpler approach is the placement of the trocar. If it is placed too far from the rib margin, it will need to be closed. This indeed leads to increased postoperative pain as described by the authors.

In conclusion, there are many ways to solve the problem of specimen extraction and decrease postoperative morbidity. The authors have demonstrated that the specimen can be opened intraabdominally if necessary without contaminating the field, but this timeconsuming approach may not be required if care is taken when placing the 15-mm extraction trocar.

Richard Peterson, MD, MPH Chief, Bariatric and Metabolic Surgery; Director, UT Medical Center for Bariatric and Metabolic Surgery; Director, Christus Weight Loss Institute, Westover Hills; Associate Professor of Surgery, University of Texas Health Science Center, San Antonio I would like to thank the authors for developing innovations that work toward improving the overall quality of patient care. Since the more widespread use of the laparoscopic sleeve gastrectomy (LSG) as a primary weight loss operation in 2008, many techniques have been adopted for various aspects of the operation. There is little question that many patients’ primary complaint after an otherwise uncomplicated LSG is specimen extraction site pain. This is related to the placement of a fascial suture to prevent hernia formation, either because of a larger trocar (15 mm), trocar site dilation, or both. The authors here look at a novel way of removing the specimen without the need for trocar site dilation.

The removal of the stomach through the 12-mm trocar is original. My concerns relate to the overall reproducibility of the technique (meaning the ability to spiral cut the specimen in one piece), the increased time that is required to do the actual spiral cutting of the specimen and the potential for intraabdominal infection either from spillage of the gastric contents or even left- behind remnants of gastric tissue.

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Opinion

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / JULY/AUGUST 2014

From ‘Innovative’ to Simple: Views Through the Retrospectoscope In our practice we began with using 15-mm trocar for two reasons. Initially, our choice of stapler required a 15-mm trocar for delivery and we continued to use that site for specimen extraction. We also began by using a laparoscopic bag retrieval system. With some difficulty in specimen extraction, we developed our technique of placement of a specimen-orienting stitch (the referenced “Tip-Stitch”). This helped, but by happenstance, when the bag ruptured in one of our cases we found that the stomach was more easily extracted without the hindrance of the plastic bag.

We then evolved our technique to a blunt dilation of the trocar site to facilitate the specimen extraction without a bag. This further evolved into a change and downsizing of the 15-mm trocar to a 12-mm when we switched to our newer stapling system. By this point, we became more comfortable with grasping the specimen by the most distal aspect with either laparoscopic graspers or a Kelly clamp through the abdominal wall and more quickly removed the specimen. We abandoned the Tip-Stitch altogether as it only added time and we found its usefulness waning as our experience improved.

Collectively, in more than 500 sleeve gastrectomies, we have had three gastric specimens open in the wound and have only seen one postoperative wound infection at that site secondary to spillage of gastric contents (the fascia was not dilated adequately, leading to difficult specimen extraction and tearing of the staple line on the specimen). Since that third gastric specimen spillage more than a year ago, we have used the Kelly

It is important that we continue to strive to improve our techniques for the betterment of our patients but also understand that a simpler solution may have been in front of us the whole time, a lesson we learned the hard way. clamp to spread the fascia of the 12-mm trocar site, which has facilitated the rapid and easy removal of the stomach. Additionally, although some patients complain about pain at the extraction site, in all but two patients it was self-limiting. These two patients were treated with an oral muscle relaxant for rectus muscle spasm with rapid relief of pain.

In essence, we ultimately tried to find an intricate solution to a problem that had a more simplified answer. Adequate dilation of the trocar site with specimen extraction can be completed in nearly all cases with very low infection rates. Placement of the fascial stitch using a transfascial suture-passing device adds very little time, and, with less than 0.4% morbidity related to trocar extraction site pain, it seems like a reasonable option in hindsight.

I think that it is important that we continue to strive to improve our techniques for the betterment of our patients but also understand that a simpler solution may have been in front of us the whole time, a lesson we learned the hard way.

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New App Predicts Complications, Costs of Ventral Hernia Repair Tool for Preoperative Discussions With Patients B Y C HRISTINA F RANGOU LAS VEGAS—It’s one of the oldest rituals between a surgeon and his or her patient: a preoperative discussion about a patient’s upcoming surgery. Now, there’s an app for that.

Hernia surgeons at Carolinas Medical

Center have created an app that calculates a patient’s risk for postoperative wound complications and the associated costs from a ventral hernia repair.

“We can use this app to talk to our patients directly. We can show them how they are impacting their own outcomes,” said B. Todd Heniford, MD, director of the Carolinas Hernia Center, Charlotte, N.C., after announcing the app at the 2014 Annual Hernia Repair meeting.

The CeDAR app, short for the

Carolinas Equation for Determining Associated Risks, predicts a patient’s risk for wound-related problems following ventral hernia repair.

The free app is intended for use by surgeons, patients or family members.

Users answer eight questions about the patient, such as his or her height and weight, body mass index, smoking status and previous hernia repairs. Using the answers, the app calculates a percentage chance that the patient will develop

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postoperative complications requiring treatment.

The mathematical formula used to calculate the risk percentage is based on data from thousands of hernia patients around the world who are registered with the International Hernia Mesh Registry.

More than 1 million data points were used to create the formula, Dr. Heniford said. Statisticians then confirmed the app’s accuracy and reliability.

CeDAR also provides an estimation of the corresponding cost of treatment.

Previous research from Carolinas Hernia Center has shown that the cost of a mesh infection after ventral hernia repair can reach six figures for a single patient’s care in the year after surgery. A patient who develops a mesh infection after surgery will incur inpatient hospital charges of $44,000 plus an additional $63,400 in follow-up costs over the next year, according to the analysis. Total expenses associated with a mesh infection can run as high as $107,000.

CeDAR is the second hernia-related app from the hernia team at Carolinas Medical Center. In 2012, the researchers released an app that predicts a patient’s risk for chronic discomfort one year after inguinal hernia repair.

William W. Hope, MD, assistant professor of surgery at the University of North Carolina, Wilmington, uses the inguinal hernia app frequently in his discussions with patients.

“It really opened my eyes.

Before, I would tell a patient that you may have some chronic groin pain, but was quite surprised when I’d put their numbers in the app and it would say a 15% to 20% risk for chronic pain. When you use the data, you really can have an honest conversation with your patient.

“It’s an exciting use of technology and an exciting way to try to predict outcomes,” he said.

Dr. Hope said he expects the ventral hernia app will encourage patients take a bigger role in their health care. “We can show them the difference it will make if they lose 20 pounds or if they quit smoking. They’ll see a difference in infection and the massive amount of money that can be saved.”

Surgeons also can use the app in discussions with health insurance companies, Dr. Heniford said.

In North Carolina, insurance companies are putting pressure on surgeons to prove that they offer high-quality care without additional costs.

Two private health insurance

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MASTECTOMY jcontinued from page 1

Toronto, Ontario, Canada, designed a qualitative study to evaluate the influence of surgeons on the growing mastectomy rate, and to ascertain differences between surgeons in Canada and the United States. She presented her findings at the 2014 annual meeting of the American Society of Breast Surgeons.

Dr. Covelli identified 45 surgeons—23 from Ontario and 22 from the United States—to participate in the study, which consisted of telephone interviews ranging from 29 to 93 minutes. The participants averaged 15 years in practice, represented both academic and nonacademic institutions, and included both fellowship- and non–fellowship-trained breast surgeons.

After a line-by-line comparative analysis of the interviews, Dr. Covelli was able to identify repeating ideas,

companies, representing 95% of privately insured patients in the state, now tier surgeons based on their clinical quality outcomes, cost efficiency and accessibility. Patients must pay extra to receive treatment from a specialist not listed in the best tier.

But it’s not always clear to patients or insurance companies that some surgeons accrue higher outcomes and costs because they treat a higher-risk population, Dr. Heniford noted.

“We can use this app to speak to insurance companies. If an insurance company says, ‘Doctor, you’re a bad surgeon,’ you can demonstrate to them the kind of patients you are operating on.”

Dr. Heniford announced the app during a presentation on “big data” and its growing role in health care. Big data is a valuable health care tool that can be used to identify trends and correlations, to improve outcomes and to track surgeons’ performance, he said.

Surgeons need to take the lead on collecting their data to accurately reflect their patient population and their outcomes, Dr. Heniford said.

“If you as a surgeon have no data, [then] you have no fight against insurance companies.”

Surgeon-driven registries are taking off in hernia repair, he said. The International Hernia Mesh Registry started in 2007, and now includes data from more than 1,265 patients over a five-year period. More recently, American surgeons launched the Americas Hernia Society Quality Collaborative, which provides real-time outcomes data for surgeons.

overall concepts and themes exploring how various factors might contribute to overall mastectomy rates.

Surgeons from both countries described an increasing rate of mastectomies over the past 10 years, Dr. Covelli said. “More notably, they shared that patients frequently came in requesting a contralateral prophylactic mastectomy, and they’ve experienced an increase in patients undergoing both unilateral and contralateral prophylactic mastectomy as treatment for early-stage breast cancer in average-risk, nongenetic-carrier patients.”

Recommendations and Consultation Dr. Covelli identified similarities and differences in how the surgeons handle consultation and recommendations. Both groups of surgeons inform patients that breast-conserving therapy (BCT) with radiation is equivalent to unilateral mastectomy for early-stage, average-risk patients. Canadian surgeons frequently recommend BCT, citing Canadian surgical guidelines as a basis for that recommendation. In contrast, U.S. surgeons usually do not offer a recommendation.

“Some U.S. surgeons would do so if

directly asked by the patients, whereas others would leave it entirely up to the patient’s choice,” Dr. Covelli said. “This may in part be reflective of legislative requirements; some states have alternative therapy laws, which mandate the discussion of all surgical treatment options.”

She also found that Ontario surgeons strongly advise against the use of contralateral prophylactic mastectomy (CPM) and advocate for treating only the diseased breast. Although U.S. surgeons neither endorse nor encourage CPM, they frequently leave the decision see MASTECTOMY page 12

Experience the ENTEREG EFFECT Accelerate your patients’ upper and lower GI recovery in surgeries that

include bowel resection

› In clinical trials, ENTEREG reduced mean time to GI recovery by 11-31.5 hours vs. placebo.1

FIRST & ONLY agent of its kind ENTEREG is indicated to accelerate the time to upper and lower gastrointestinal (GI) recovery following surgeries that include partial bowel resection with primary anastomosis.

Important Safety Information for ENTEREG

› ›

WARNING: POTENTIAL RISK OF MYOCARDIAL INFARCTION WITH LONG-TERM USE: FOR SHORT-TERM HOSPITAL USE ONLY Increased incidence of myocardial infarction was seen in a clinical trial of patients taking alvimopan for long-term use.

No increased risk was observed in short-term trials.

Because of the potential risk of Myocardial Infarction, ENTEREG is available only through a restricted program for short-term use (15 doses) called the ENTEREG Access Support and Education (E.A.S.E.®) ENTEREG REMS Program.

Contraindications

› ENTEREG Capsules are contraindicated in patients who have

taken therapeutic doses of opioids for more than 7 consecutive days immediately prior to taking ENTEREG.

Warnings and Precautions

› There were more reports of myocardial infarctions in patients

treated with alvimopan 0.5 mg twice daily compared with placebo-treated patients in a 12-month study of patients treated with opioids for chronic pain. In this study, the majority of myocardial infarctions occurred between 1 and 4 months after initiation of treatment. This imbalance has not been observed in other studies of alvimopan, including studies of patients undergoing bowel resection surgery who received alvimopan 12 mg twice daily for up to 7 days. A causal relationship with alvimopan has not been established.

› ENTEREG should be administered with caution to patients receiving more than 3 doses of an opioid within the week

›

prior to surgery. These patients may be more sensitive to ENTEREG and may experience GI side effects (e.g., abdominal pain, nausea and vomiting, diarrhea).

ENTEREG is not recommended for use in patients with severe hepatic impairment, end-stage renal disease, complete gastrointestinal obstruction, or pancreatic or gastric anastomosis, or in patients who have had surgery for correction of complete bowel obstruction.

Adverse Reactions

› The most common adverse reaction (incidence ≥1.5%) occurring with a higher frequency than placebo among ENTEREG treated patients undergoing surgeries that included a bowel resection was dyspepsia (ENTEREG, 1.5%; placebo, 0.8%).

E.A.S.E.® Program for ENTEREG

› ENTEREG is available only to hospitals that enroll in the E.A.S.E. ENTEREG REMS Program. To enroll in the E.A.S.E. Program, the hospital must acknowledge that:

– Hospital staff who prescribe, dispense, or administer

ENTEREG have been provided the educational materials on the need to limit use of ENTEREG to short-term, inpatient use

– Patients will not receive more than 15 doses of ENTEREG – ENTEREG will not be dispensed to patients after they have been discharged from the hospital

Please see following brief summary of Prescribing Information.

Reference: 1. ENTEREG (Prescribing Information). Cubist Pharmaceuticals, Inc.; Lexington, MA.

www.cubist.com ©2012 Cubist Pharmaceuticals 5628121613 January 2014. ENTEREG and E.A.S.E.® are registered trademarks of Cubist Pharmaceuticals, Inc.

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In the News MASTECTOMY jcontinued from page 11

up to the patient.

The two groups of surgeons also differ in their discussions regarding reconstruction, with Canadian surgeons broaching the topic only if patients are considering a unilateral mastectomy. “In the U.S., the discussion around reconstruction was introduced to every patient, very early in their initial consultation,” Dr. Covelli said.

Again, this is in part reflective of legislative mandates, but it is also reflective

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / JULY/AUGUST 2014

of access, she said, noting that although reconstruction in Canada is mainly limited to patients at academic or high-volume centers, the U.S.-based surgeons all had good access to immediate reconstruction.

In both countries, patients who choose unilateral mastectomy are sent for consultation with a reconstructive surgeon.

“Many of the surgeons at high-volume centers in both Canada and the United States shared that not infrequently patients would return requesting bilateral surgery with reconstruction as they had been informed they would achieve better symmetry and balance,” Dr. Covelli said.

The Role of Magnetic Resonance Imaging Use of magnetic resonance imaging (MRI) is thought to influence a preference for mastectomy due its high rate of false positives, which may provoke patient fears and sway them toward the more extensive procedure. Dr. Covelli found that the Canada-based surgeons were always the physician who ordered the preoperative MRI, which allowed them to selectively use the MRI if so indicated, and to counsel patients on the benefits and limitations of MRI. “In contrast, the U.S. surgeons showed

BRIEF SUMMARY

ENTEREG® (alvimopan) Capsules The following is a brief summary only; see full prescribing information for complete product information.

WARNING: POTENTIAL RISK OF MYOCARDIAL INFARCTION WITH LONG-TERM USE: FOR SHORT-TERM HOSPITAL USE ONLY There was a greater incidence of myocardial infarction in alvimopan-treated patients compared to placebo-treated patients in a 12-month clinical trial, although a causal relationship has not been established. In short-term trials with ENTEREG®, no increased risk of myocardial infarction was observed [see Warnings and Precautions (5.1)]. ] Because of the potential risk of myocardial infarction with long-term use, ENTEREG is available only through a restricted program for short-term use (15 doses) under a Risk Evaluation and Mitigation Strategy (REMS) called the ENTEREG Access Support and Education (E.A.S.E.®) Program [see Warnings and Precautions (5.1) and (5.2)]. ] 1

INDICATIONS AND USAGE ENTEREG is indicated to accelerate the time to upper and lower gastrointestinal recovery following surgeries that include partial bowel resection with primary anastomosis.

4 CONTRAINDICATIONS ENTEREG is contraindicated in patients who have taken therapeutic doses of opioids for more than 7 consecutive days immediately prior to taking ENTEREG [see Warnings and Precautions (5.3)].]

5 WARNINGS AND PRECAUTIONS 5.1 Potential Risk of Myocardial Infarction with Long-term Use There were more reports of myocardial infarctions in patients treated with alvimopan 0.5 mg twice daily compared with placebo-treated patients in a 12-month study of patients treated with opioids for chronic non-cancer pain (alvimopan 0.5 mg, n = 538; placebo, n = 267). In this study, the majority of myocardial infarctions occurred between 1 and 4 months after initiation of treatment. This imbalance has not been observed in other studies of ENTEREG in patients treated with opioids for chronic pain, nor in patients treated within the surgical setting, including patients undergoing surgeries that included bowel resection who received ENTEREG 12 mg twice daily for up to 7 days (the indicated dose and patient population; ENTEREG 12 mg, n = 1,142; placebo, n = 1,120). A causal relationship with alvimopan with long-term use has not been established.

ENTEREG is available only through a program under a REMS that restricts use to enrolled hospitals [see Warnings and Precautions (5.2)].

5.2 E.A.S.E. ENTEREG REMS Program ENTEREG is available only through a program called the ENTEREG Access Support and Education (E.A.S.E.) ENTEREG REMS Program that restricts use to enrolled hospitals because of the potential risk of myocardial infarction with long-term use of ENTEREG [see Warnings and Precautions (5.1)].

Notable requirements of the E.A.S.E. Program include the following: ENTEREG is available only for short-term (15 doses) use in hospitalized patients. Only hospitals that have enrolled in and met all of the requirements for the E.A.S.E. program may use ENTEREG. To enroll in the E.A.S.E. Program, an authorized hospital representative must acknowledge that: hospital staff who prescribe, dispense, or administer ENTEREG have been provided the educational materials on the need to limit use of ENTEREG to short-term, inpatient use; patients will not receive more than 15 doses of ENTEREG; and ENTEREG will not be dispensed to patients after they have been discharged from the hospital.

Further information is available at www.ENTEREGREMS.com or 1-877-282-4786.

5.3 Gastrointestinal-Related Adverse Reactions in Opioid-Tolerant Patients Patients recently exposed to opioids are expected to be more sensitive to the effects of μ-opioid receptor antagonists, such as ENTEREG. Since ENTEREG acts peripherally, clinical signs and symptoms of increased sensitivity would be related to the gastrointestinal tract (e.g., abdominal pain, nausea and vomiting, diarrhea).

Patients receiving more than 3 doses of an opioid within the week prior to surgery were not studied in the postoperative ileus clinical trials. Therefore, if ENTEREG is administered to these patients, they should be monitored for gastrointestinal adverse reactions. ENTEREG is contraindicated in patients who have taken therapeutic doses of opioids for more than 7 consecutive days immediately prior to taking ENTEREG. 5.4 Risk of Serious Adverse Reactions in Patients with Severe Hepatic Impairment Patients with severe hepatic impairment may be at higher risk of serious adverse reactions (including dose-related serious adverse reactions) because up to 10-fold higher plasma levels of drug have been observed in such patients compared with patients with normal hepatic function. Therefore, the use of ENTEREG is not recommended in this population.

5.5 End-Stage Renal Disease No studies have been conducted in patients with end-stage renal disease. ENTEREG is not recommended for use in these patients.

5.6 Risk of Serious Adverse Reactions in Patients with Complete Gastrointestinal Obstruction No studies have been conducted in patients with complete gastrointestinal obstruction or in patients who have surgery for correction of complete bowel obstruction. ENTEREG is not recommended for use in these patients.

5.7 Risk of Serious Adverse Reactions in Pancreatic and Gastric Anastomoses ENTEREG has not been studied in patients having pancreatic or gastric anastomosis. Therefore, ENTEREG is not recommended for use in these patients.

6 ADVERSE REACTIONS 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be compared directly with rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The adverse event information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates.

The data described below reflect exposure to ENTEREG 12 mg in 1,793 patients in 10 placebo-controlled studies. The population was 19 to 97 years old, 64% were female, and 84% were Caucasian; 64% were undergoing a surgery that included bowel resection. The first dose of ENTEREG was administered 30 minutes to 5 hours before the scheduled start of surgery and then twice daily until hospital discharge (or for a maximum of 7 days of postoperative treatment).

Among ENTEREG-treated patients undergoing surgeries that included a bowel resection, the most common adverse reaction (incidence ≥1.5%) occurring with a higher frequency than placebo was dyspepsia (ENTEREG, 1.5%; placebo, 0.8%). Adverse reactions are events that occurred after the first dose of study medication treatment and within 7 days of the last dose of study medication or events present at baseline that increased in severity after the start of study medication treatment.

7 DRUG INTERACTIONS 7.1 Potential for Drugs to Affect Alvimopan Pharmacokinetics An in vitroo study indicates that alvimopan is not a substrate of CYP enzymes. Therefore, concomitant administration of ENTEREG with inducers or inhibitors of CYP enzymes is unlikely to alter the metabolism of alvimopan.

7.2 Potential for Alvimopan to Affect the Pharmacokinetics of Other Drugs Based on in vitroo data, ENTEREG is unlikely to alter the pharmacokinetics of coadministered drugs through inhibition of CYP isoforms such as 1A2, 2C9, 2C19, 3A4, 2D6, and 2E1 or induction of CYP isoforms such as 1A2, 2B6, 2C9, 2C19, and 3A4.

In vitro, ENTEREG did not inhibit p-glycoprotein.

7.3

Effects of Alvimopan on Intravenous Morphine Coadministration of alvimopan does not appear to alter the pharmacokinetics of morphine and its metabolite, morphine-6-glucuronide, to a clinically significant degree when morphine is administered intravenously. Dosage adjustment for intravenously administered morphine is not necessary when it is coadministered with alvimopan.

7.4 Effects of Concomitant Acid Blockers or Antibiotics A population pharmacokinetic analysis suggests that the pharmacokinetics of alvimopan were not affected by concomitant administration of acid blockers or antibiotics. No dosage adjustments are necessary in patients taking acid blockers or antibiotics.

8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Pregnancy Category B Risk Summary: y There are no adequate and/or well-controlled studies with ENTEREG in pregnant women. No fetal harm was observed in animal reproduction studies with oral administration of alvimopan to rats at doses 68 to 136 times the recommended human oral dose, or with intravenous administration to rats and rabbits at doses 3.4 to 6.8 times, and 5 to 10 times, respectively, the recommended human oral dose.

Because animal reproduction studies are not always predictive of human response, ENTEREG should be used during pregnancy only if clearly needed.

Animal Data: Reproduction studies were performed in pregnant rats at oral doses up to 200 mg/kg/day (about 68 to 136 times the recommended human oral dose based on body surface area) and at intravenous doses up to 10 mg/kg/day (about 3.4 to 6.8 times the recommended human oral dose based on body surface area) and in pregnant rabbits at intravenous doses up to 15 mg/kg/day (about 5 to 10 times the recommended human oral dose based on body surface area), and revealed no evidence of impaired fertility or harm to the fetus due to alvimopan.

8.3 Nursing Mothers It is not known whether ENTEREG is present in human milk. Alvimopan and its ‘metabolite’ are detected in the milk of lactating rats. Exercise caution when administering ENTEREG to a nursing woman [see Clinical Pharmacology (12.3)].

8.4 Pediatric Use Safety and effectiveness in pediatric patients have not been established.

8.5 Geriatric Use Of the total number of patients in 6 clinical efficacy studies treated with ENTEREG 12 mg or placebo, 46% were 65 years of age and over, while 18% were 75 years of age and over. No overall differences in safety or effectiveness were observed between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. No dosage adjustment based on increased age is required [see Clinical Pharmacology (12.3)].

8.6 Hepatic Impairment ENTEREG is not recommended for use in patients with severe hepatic impairment.

Dosage adjustment is not required for patients with mild-to-moderate hepatic impairment. Patients with mild-to-moderate hepatic impairment should be closely monitored for possible adverse effects (e.g., diarrhea, gastrointestinal pain, cramping) that could indicate high drug or ‘metabolite’ levels, and ENTEREG should be discontinued if adverse events occur [see Warnings and Precautions (5.4) and Clinical Pharmacology (12.3)].]

8.7 Renal Impairment ENTEREG is not recommended for use in patients with end-stage renal disease. Dosage adjustment is not required for patients with mild-to-severe renal impairment, but they should be monitored for adverse effects. Patients with severe renal impairment should be closely monitored for possible adverse effects (e.g., diarrhea, gastrointestinal pain, cramping) that could indicate high drug or ‘metabolite’ levels, and ENTEREG should be discontinued if adverse events occur [see Clinical Pharmacology (12.3)].

8.8 Race No dosage adjustment is necessary in Black, Hispanic, and Japanese patients. However, the exposure to ENTEREG in Japanese healthy male volunteers was approximately 2-fold greater than in Caucasian subjects.

Japanese patients should be closely monitored for possible adverse effects (e.g., diarrhea, gastrointestinal pain, cramping) that could indicate high drug or ‘metabolite’ levels, and ENTEREG should be discontinued if adverse events occur [see Clinical Pharmacology (12.3)].

13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis: g Two-year carcinogenicity studies were conducted with alvimopan in CD-1 mice at oral doses up to 4000 mg/kg/day and in Sprague-Dawley rats at oral doses up to 500 mg/kg/day. Oral administration of alvimopan for 104 weeks produced significant increases in the incidences of fibroma, fibrosarcoma, and sarcoma in the skin/subcutis, and of osteoma/osteosarcoma in bones of female mice at 4000 mg/kg/day (about 674 times the recommended human dose based on body surface area). In rats, oral administration of alvimopan for 104 weeks did not produce any tumor up to 500 mg/kg/day (about 166 times the recommended human dose based on body surface area).

Mutagenesis: g Alvimopan was not genotoxic in the Ames test, the mouse lymphoma cell (L5178Y/TK+/−) forward mutation test, the Chinese Hamster Ovary (CHO) cell chromosome aberration test, or the mouse micronucleus test. The pharmacologically active ‘metabolite’ ADL 08-0011 was negative in the Ames test, chromosome aberration test in CHO cells, and mouse micronucleus test.

Impairment p of Fertility: y Alvimopan at intravenous doses up to 10 mg/kg/day (about 3.4 to 6.8 times the recommended human oral dose based on body surface area) was found to have no adverse effect on fertility and reproductive performance of male or female rats.

17 PATIENT COUNSELING INFORMATION 17.1 Recent Use of Opioids Patients should be informed that they must disclose long-term or intermittent opioid pain therapy, including any use of opioids in the week prior to receiving ENTEREG. They should understand that recent use of opioids may make them more susceptible to adverse reactions to ENTEREG, primarily those limited to the gastrointestinal tract (e.g., abdominal pain, nausea and vomiting, diarrhea).

17.2 Hospital Use Only ENTEREG is available only through a program called the ENTEREG Access Support and Education (E.A.S.E.) Program under a REMS that restricts use to enrolled hospitals because of the potential risk of myocardial infarction with long-term use of ENTEREG. Patients should be informed that ENTEREG is for hospital use only for no more than 7 days after their bowel resection surgery.

17.3 Most Common Side Effect Patients should be informed that the most common side effect with ENTEREG in patients undergoing surgeries that include bowel resection is dyspepsia.

ENTEREG and E.A.S.E. are registered trademarks of Adolor Corporation, a wholly owned subsidiary of Cubist Pharmaceuticals, Inc. Any other trademarks are property of their respective owners.

Manufactured for: Cubist Pharmaceuticals, Inc. Lexington, MA 02421 USA October 2013

‘We are seeing a significant number of women choosing mastectomy or adding contralateral mastectomy in situations where these procedures do not improve survival.’

—Victor Zannis, MD

that MRI was often completed before they saw the patient, frequently at a side imaging facility,” she said. “This limited the surgeons’ ability to be selective about the use of MRI, and to counsel patients about the high rate of false positives, and the sensitivity that may lead to additional workups.”

The Surgeon, the Environment In summary, Dr. Covelli found that surgeons from both countries tended to be of one mind: Describe BCT and unilateral mastectomy as equivalent options, but do not endorse the use of CPM. “It was always the patients who initiated the request for bilateral mastectomy or unilateral and CPM,” Dr. Covelli said.

The differences lay in the practice milieu, which had the ability to shape the surgical consultation and influence patients’ decisions.

“In conclusion, I didn’t find any role of the surgeon encouraging the choice for more extensive surgery, but the practice environment factors, MRI, reconstruction legislation and guidelines, are in fact inadvertently influencing the increasing mastectomy rates,” Dr. Covelli said.

Victor Zannis, MD, FACS, medical director of the Comprehensive Breast Center of Arizona, Phoenix, believes Dr. Covelli’s research accurately describes the factors affecting women’s surgical decisions.

“We are seeing a significant number of women choosing mastectomy or adding contralateral mastectomy in situations where these procedures do not improve survival,” Dr. Zannis said. “As a surgeon who counsels women in this arena daily, I believe the surgeon has a lot of influence on the decision making.”

It is imperative, he said, that surgeons make it clear to their patients that more conservative surgery with equal survival is advantageous for its potential to obviate the downsides associated with more extensive procedures: postoperative pain, complications, the need for reconstruction and cost.

“We should let the patient know it’s OK to save their breasts in cases of equal survival, essentially giving them permission to nott do radical surgery for their cancer,” he said.

In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / JULY/AUGUST 2014

VENOUS THROMBOEMBOLISM jContinued from page 1 penalties through the CMS Value-Based Purchasing Initiative.

But surgeons have criticized the VTE outcome measure, arguing that these events do not reflect poor hospital care.

Some evidence backs up this argument.

A previous study from the Surgical Outcomes and Quality Improvement Center at Northwestern University found that hospitals with higher rates of VTE perform more imaging studies than other hospitals ((JAMA 2013;310:14821489).

That report, however, was criticized for its use of Medicare administrative data, which provide limited information about preoperative risk factors and exclude VTE events that occur in the post-discharge period. Administrative claims data also have higher false-positive and false-negative rates.

Dr. Ju and her colleagues designed the new study to

overcome problems in previous studies.

They used ACS National Surgical Quality Improvement Program (NSQIP) data reported by 208 hospitals in 2009 and 2010. Patients in the study underwent 11 major surgical procedures associated with higher VTE rates. The data set included more than 30 patient factors for risk adjustment.

The analysis confirmed the previous study’s finding: VTE events in the first 30 days after surgery occurred more often at hospitals that performed more imaging studies.

Hospitals in the lowest quartile for

imaging reported a VTE rate of 1.13%, whereas those in the highest quartile reported a rate of 1.91% (P<0.001).

This trend persisted for VTE events that occurred only during the hospital stay.

Samuel R.G. Finlayson, MD, MPH, chair of surgery at the University of Utah, said the study raises important questions about how quality is measured.

“While comparing hospitals based on their rates of adverse outcomes appears, on the surface, to be a simple and fair approach, it turns out that quality in health care is much more complicated than that,” said Dr. Finlayson, who was

the official discussant of the paper. “The problems that the authors have uncovered related to VTE rates strengthen the argument of those who believe that outcome-based, pay-for-performance programs are not ready for prime time.”

He noted that the research leaves some questions unanswered, such as why these hospitals conduct additional imaging tests.

VTEs occur too infrequently to be used as a quality measure, said Hiram C. Polk, MD, professor of surgery at the University of Louisville, in Kentucky, in see VENOUS THROMBOEMBOLISM page 22

Another synthetic mesh removal.

KEY POINTS A previous study from the Surgical Outcomes and Quality Improvement Center at Northwestern University found that hospitals with higher rates of VTE perform more imaging studies than other hospitals (JAMA 2013;310:1482-1489).

In the current study, VTE events in the first 30 days after surgery occurred more often at hospitals that performed more imaging studies.

Hospitals that used VTE imaging more often were also those most likely to adhere to Surgical Care Improvement Project’s VTE prophylaxis guidelines. This may reflect an assumption that increased imaging intensity is associated with better quality.

And considering the average $31k cost of explantation, there goes our upfront cost savings.1

Why would you use anything other than Strattice™ Reconstructive Tissue Matrix in your Complex AWR patients?

Fact is, postoperative infection occurs in 26% of Complex AWR patients with a synthetic mesh,1 and removal of infected mesh has been shown to be 65% more costly than the average VHR admission.1,2 This can put a tremendous burden on the surgeon, the patient and the healthcare system at large.3

Strattice™ Tissue Matrix is clinically differentiated from other repair types in Complex AWR: • Can decrease downstream complications 5-fold in Complex AWR patients, and costs by 2-fold1 • Studied in more than 1,100 Complex AWR patients in 50 peer-reviewed articles 4 • <1% incidence of explantation reported in all peer-reviewed articles • Provides for a long-term repair4 1 LifeCell data on file based on a longitudinal analysis of private and public insurance claims from the Truven MarketScan® Database. Patients were followed from their initial procedure in 2007 for 18 months. (n=740).

2 Reynolds D, Davenport DL, Korosec RL, Roth JS. Financial implications of ventral hernia repair: a hospital cost analysis. J Gastrointest Surg.2013 Jan;17(1):159-66.

3 Poulose BK, Beck WC, Phillips SE, et al. The Chosen Few: Disproportionate Resource Use in Ventral Hernia Repair. Am Surg. 2013 Aug; 79(8):815-8..

4 Searches performed on PubMed, Google, Google Scholar and ScienceDirect® in September 2013. Each study was considered independent during calculation.

Studies may contain overlapping patient populations.

Before use, physicians should review all risk information, which can be found in the Instructions for Use attached to the packaging of each LifeCell™ Tissue Matrix graft. © 2014 LifeCell Corporation. All rights reserved. Strattice™ is a trademark of LifeCell Corporation. MLC4001/3898/4-2014

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In the News SIMULATORS

jcontinued from page 1 after leaving the air force, he was astonished that medical trainees honed their skills not on simulators, but on real patients.

“We expect both health care and aviation to have very low tolerance for errors.

But in health care, we are very much behind aviation in that respect,” Dr. Ziv said in a lecture at the 2014 Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) meeting.

“Our health care training, despite the

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / JULY/AUGUST 2014

simulation movement, is still by and large the old model: See one, teach one, do one, kill one. … The patients are the ones who pay the price,” said Dr. Ziv, chair of medical education, Sackler School of Medicine, Tel Aviv University.

Dr. Ziv, a pediatrician, has spent the past 20 years trying to adapt the lessons of flight simulation training to the field of medical training.

According to his bio, this idea came to him in medical school when a fellow student committed suicide hours after failing a test. The future Dr. Ziv decided then that the testing system, both to get into

medical school and to become a licensed physician, was inadequate. It focused purely on a student’s cognition. The system failed to assess the human side of being a physician.

Driven by this realization, Dr. Ziv completed his MD dissertation on peer evaluation. Later, he worked with the Educational Commission for Foreign Medical Graduates on a simulation-based program that certifies foreign immigrant doctors applying to work in the United States.

In 2001, Dr. Ziv returned to Israel and founded the Israel Center for Medical Simulation (MSR), now “arguably one of

Amitai Ziv, MD, believes personality traits should count more when evaluating medical students and physicians. the most effective and influential simulation centers in the world,” said Gerald Fried, MD, immediate past president of SAGES and chair of surgery at McGill University, in Montreal, Canada.

Housed in a virtual hospital on the massive Chaim Sheba Medical Center campus just outside Tel Aviv, MSR is home to more than 100 different kinds of simulators and employs more than 150 professional actors for its courses.

The nonprofit center, which operates on a fee-for-service model, trains more than 10,000 health professionals in more than 60 courses annually.

Almost all health care practitioners in Israel have undergone some training at MSR. The student body ranges from medical school applicants to hospital CEOs. Among the trainees are pharmacists who learn communication skills that can help with angry patients and reduce errors; surgeons who rehearse complex procedures in a high-tech operating room simulator; and surgical residents who practice on virtual-reality simulators. MSR instructors watch everything through one-way mirrors and conduct extensive aviation-style debriefs. Even the country’s medical clowns refine their skills through courses at MSR. MSR trains health care workers for run-of-the-mill scenarios but also for the catastrophic “unimaginable” ones. Israel is known for its extensive mass casualty preparedness; much of that training is conducted at MSR. Notably, the training extends also to Palestinians; MSR uses simulation to provide trauma training for Palestinian physicians and paramedics through an affiliation with Physicians for Human Rights.

MSR’s simulation model can be used around the world to improve safety and medical training, Dr. Fried said. “This can reshape the way medical care is delivered around the world.”

The center is founded on the principle that simulation-based medical training

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and assessment can revolutionize the safety culture in medicine. For too long, medicine has accepted suboptimal levels of safety, said Dr. Ziv, deputy director of Sheba Medical Center, responsible for patient safety, risk management and medical education.

He likes to compare medicine to aviation. If the deaths attributed to medical errors are put into aviation terms, they amount to four Boeing 747 crashes daily, Dr. Ziv said, citing a recent controversial study in the Journal of Patient Safety (2013;9:122-128).

Medical errors disproportionately affect women, children and older patients, he added. “This is not something intentional, but these are groups, perhaps, that we do not communicate as effectively with.”

Simulation, which ranges from expensive high-tech simulators to low-tech role-playing with actors, provides an environment for people to learn by hands-on practice but without putting patients’ lives at risk, Dr. Ziv said. “This is a very powerful way of teaching.”

Dr. Ziv pointed to data collected by the American nonprofit behavioral psychology center, the National Training Laboratory, which showed that learners who are taught by hands-on practice retain around 75% of information. In contrast, students remember about 5% of what they hear in lectures, 10% of what they read and 30% of what they see.

A key advantage of simulation is that it can teach skills needed in emergency situations, the medical equivalents of trying to land a plane with a fire in the cockpit, Dr. Ziv said. These are low-frequency but high-stakes scenarios.

MSR runs programs to teach trainees and practicing physicians how to respond in so-called “nightmare scenarios.” There is even a module known as the “nightmare course,” a mandatory five-day program for Israeli interns about to begin their first hospital rotations. They are challenged with a series of stressful situations such as finding themselves in an elevator alone at night with a patient who stops breathing.

“Or it could be the nightmare on the emotional front: telling a family that we have erred and we gave their father the wrong blood, that we are responsible for the loss of a loved one,” Dr. Ziv said.

“It’s through this kind of proactive learning, rather than [a] reactive one with our apprentice one, [that] we can enact nightmares.”

Dr. Ziv asserted that medical errors occur because of malfunctions built into the health care system from the moment applicants are evaluated as candidates for medical school. At most medical schools, the application committee considers grades and extracurricular activities, but places little emphasis on personality traits.

But medical schools need to consider personality traits, Dr. Ziv said. And

so, MSR, together with Israeli medical schools and Israel’s National Institute for Testing and Evaluation, developed an assessment program—known as MOR, a Hebrew acronym for “selection for medicine”—to measure candidates’ judgment and decision-making skills. Candidates complete a series of behavioral stations, including encounters with simulated patients and group tasks, an autobiographical questionnaire, and a judgment and decision-making questionnaire. They are evaluated on interpersonal communication skills, ability to handle stress, initiative and responsibility, and self-awareness.

This program resulted in a change of about 20% in the cohort of accepted students compared with previous admission criteria (Med Educ 2008;42:991-998).

The investigators found very low correlation between the candidates’ MOR scores and cognitive scores.

“MOR conveys the importance of maintaining humanistic characteristics in the medical profession to students and faculty staff,” Dr. Ziv noted.

He would like to see similarly thorough assessments of physicians throughout their career. Physicians should be evaluated on all aspects of the care they provide,

from their ability to deal with high-stress situations to their operative skill, he said.

“Surgeons can be operating with Parkinson’s and nobody can ground that surgeon. That’s true today around the world and it is not right.”

Dr. Ziv hoped that simulation-based medical education will spark a revolution in medicine.

“We will have to change course. We have some barriers but they are not as high as we think. The end of it, there’s the humility message that if we meet our errors in the simulation environment, we will be better off in the real world,” he said.

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Opinion LOVE

jcontinued from page 1 she was referred to our hernia program.

I first met her in the office. She was with her sister, who had recently received a lung transplant. They both had been smokers, and Mrs. George’s lungs were compromised. After our team explained the options and risks, she decided to have an abdominal wall reconstruction.

Although the procedure went well, she began to develop pulmonary complications on the third postoperative day and required intubation. That was not unexpected. What was unexpected was a computed tomography (CT) scan a few days later that showed liters of fluid over her liver; she had a common bile duct obstruction and her gallbladder had perforated. We placed drains to evacuate the bile from her abdominal cavity, and she was able to be extubated soon after that. A few days later, she had a distal esophageal obstruction and required an esophagogastroduodenoscopy and dilation. The CT also revealed a left ureteral obstruction that caused pain but eventually resolved.

Through all of these complications, I got to know Mrs. George and her family.

Her husband was a quiet, kind and gentle man, and her daughter was a tough and

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / JULY/AUGUST 2014

passionate woman (much like her mom).

They and the sister I had met at the office were present and were supportive throughout. When patients have complications like this, surgeons sometimes try to avoid seeing the patient and especially the family, not only because of the time it takes but also because of the discomfort involved in seeing your patient suffer from multiple complications. I have done that, I am ashamed to say, many times in my career.

‘Healthy distance’ may actually be a facade that keeps us from being authentic and fully human to the benefit of our patients and even for ourselves.

In this case, our patient care manager and I did try to spend extra time with Mrs. George and her family because of the suffering that she was enduring. After almost a month, Mrs. George’s anger at her primary care physician and her surgeon for not diagnosing her hernia was transitioning into an increased effort to heal and go home. In the process, we were developing a loving relationship with

each other. One day, while she waas up in the chair, with three drainage tubes coming out of her right upper quadrant, she said to me, “Come here, I want a hug,” and as I hugged her, she said, “I loove you.”

Without thinking about a respon nse, I said, “I love you, too.” This was one of the most important moments in my maturing as a surgeon and as a person.

Love and Leadership Many in our profession would try to convince us that we should keep a healthy emotional distance between ourselves and our patients—thaat it may be dangerous to care too much, and we should especiallly not get too close, or God forbid, loove our patients. But is keeping a health hy emotional distance really the right thing to do? “Healthy distance” may actuaally be a facade that keeps us from being authenth tic and fully human to the benefit it off our patients and even for ourselves.

Brene Brown, a self-described “researcher-storyteller,” is a research professor of social work at the University of Houston. After eight years of research on the topic, she characterizes being an authentic human being as having

“ h l h t d “wholeheartedness.” ” She Sh defined d fi d the th characteristics that produced a wholehearted human being as things such as trust, faith, hope, joy, belonging, gratitude and creativity. Sadly, characteristics that prevent wholeheartedness are more telling, and representative of our profession: perfection, certainty, self-sufficiency,

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Instead of recognizing that the clinical care environment is the problem, medical school leaders have suggested identifying applicants with higher empathy for medical school admission. fitting-in and judggment; they look likke the goals of ou ur surgical trainingg.

What do patientts consistently ask foor from a physician n?

They ask for authen nticity, empathy and ultiimately love, so that theey feel cared for. This is especiallly important when unexpected compliications occur.

There is a growing realization thaat organizational leadership in the 21st cen ntury is rapidly changing. The command and d control t l lleadership d hi off hi hierarchical hi organizations i ti made d up off iincreasingi ly fragmented department silos is giving way to the leader as a facilitator of small teams. Other industries are realizing that the leader most likely to ensure long-term success is one who embodies the wholehearted human being described by Brene Brown. When will the health care profession realize this? In our industry, that is designed specifically to care for other human beings, why do we find a lack of love in our organizations?

As physicians, we have been inundated with “evidence-based medicine” and “quality measures,” but what is really needed in health care is evidence-based management. Creating an environment that facilitates love and empathy should be a primary focus. More than a dozen studies demonstrate that the moment when medical students begin to lose their ability to be empathic is when they step into the clinical environment.

Instead of recognizing that the clinical care environment is the problem, medical school leaders have suggested identifying applicants with higher empathy for medical school admission. Evidencebased management would allow for organizational change that would foster love and empathy in the clinical care environment, instead of suppress it.

Love Does Not Exist in a Hierarchy In the 1960s, Stanley Milgram ran a series of experiments to see if the horror of the Holocaust in Nazi Germany could be repeated in the United States. He demonstrated, based on various conditions, that up to 90% of normal adults would deliver a potentially fatal electric shock to another person while participating in an experiment to help improve learning.

In his book, Obedience to Authority, about this series of experiments, Milgram describes the conditions necessary to

achieve this disturbing result: “To create this evil, a hierarchy is necessary. Authority systems must be based on people arranged in a hierarchy.

Thus, the critical question in determining control is: Who is over whom? How much over is far less important than the visible presence of a ranked ordering.”

The fragmentation of responsibility allows a person to relinquish accountability to someone higher up the chain of command. For years, we have seen this erosion in the nursing profession: Nurses have given up their responsibility to the authority above them—the doctor. In fact, a variation of the Milgram study was conducted in health care: In a study in the Midwest, more than 90% of nurses in the study were going to give a fatal dose of a drug that was not on formulary (it was an experimental drug in the hospital only on a clinical trial) based on a phone order by

a “doctor,” who was actually the experimenter using a name that was not a physician on the hospital staff. This is unlikely to happen today (nurses have mandates and guidelines that prevent such phone orders), but there are new authority figures that perpetrate similar harm: the electronic medical record, and more and more, hospital policy and government mandates. How many of us just give up resisting mandates and policies that make no sense when we want to avoid the hassle of dealing with some authority figure, who will label us as see LOVE page 18

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LOVE

jcontinued from page 17 disruptive or a nuisance?

Developing Care Communities (Teams) With Patients If conditions of fragmentation and hierarchy can create environments that lead to a lack of responsibility and facilitate the potential for harm, can different conditions create environments that lead to accountability and that foster love and empathy? The Robbers Cave experiment, conducted over a three-week period

in summer 1954, can help us understand the potential.

A group of camp counselors (actually, the experimenters), randomly divided 22 boys, aged 11 and 12 years, into two groups. Each group was given a name and the two groups were initially isolated from one another. During this period, the counselors allowed for group bonding while each group had no knowledge that the other group existed. Then, they brought the two groups together for a variety of competitive activities. What a mess! There was screaming and yelling of derogatory comments and many fights

broke out. Clearly, it was not difficult to fragment a group of boys and create perceived hatred for each other.

Then the real experiment began. The counselors created a series of obstacles and challenges that required the two groups to work together to achieve common goals, such as fixing the broken-down bus so they could go to town to watch a movie. As the groups worked together, the hatred and fear melted away, replaced by new connections and friendships. By the end of the experiment, the two groups had become one, unified by the achievement of solving

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problems together. This “realistic conflict theory” has been demonstrated over and over again, and the solution of having small teams work collaboratively with a common goal should have no better application than in health care.

If we can create conditions and environments that lead to bad behaviors, we can also create conditions and environments that foster love, empathy and engagement, a passion for what we are privileged to do: care for another person. These conditions, based on numerous studies, include the creation of small teams given the resources, authority and responsibility to provide care for a defined group of patients throughout their entire cycle of care. A team is not the several thousand employees who happen to be employees of a hospital or an academic medical center, a few people who come together on a certain day in the operating room, or even a departmental silo, but a small group composed of the diverse skills the patient needs; in health care, each team should include the patient and the patient’s family.

Challenges Can Bring Teams Together In sports, teams compete against each other. In health care, our teams are designed around a group of people suffering from a health problem, and with these patients, our teams can be driven to define, measure and improve the value of care. The spirit is cooperation, not competition. To do this, we must be vulnerable, transparent, empathic and loving; we must be wholehearted persons. As physicians, we will need to be leaders on these teams, facilitating an environment that will allow us to trust and love others on our team, especially including the patient and family members for whom we provide care. Visionary leaders who will create such a unifying atmosphere are desperately needed in health care.

About 24 hours after Mrs. George was discharged, her family brought her back to the emergency room with frequent vomiting and dehydration. The next day, she developed lesions on her left buttock, groin and perineum that became one of the worst cases of shingles I have ever seen. Each day, her husband helped the nurses with the various care tasks and tried to comfort his wife. Each day, our team saw her and heard about the intense suffering she experienced: regular dry heaves every few minutes, rarely with anything to vomit, excruciating pain in the area of the shingles lesions, severe depression and a desire to be medicated to blunt this suffering. At one point, she stopped breathing and a code was called. She was given Narcan and sent to the medical ICU. She continued to have problems. Fluid built up in her lungs, and after several pleuricenteses, a chest tube was placed. Her

Opinion

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As physicians, we will need to be leaders on these teams, facilitating an environment that will allow us to trust and love others on our team, especially including the patient and family members for whom we provide care. husband and sister continued to love her and try to encourage her; our hernia team, the patient care manager and I continued to love her and her family and tried to support them in any way we could. We were a team trying to facilitate Mrs. George’s healing.

We asked for help from many other medical and surgical consultants. We even considered sedating her and putting her on a ventilator just to relieve her suffering. Over the next month, Mrs. George appeared to be giving up; the suffering had become too great. I can’t remember in my career having watched someone suffer in the hospital so much and not be intubated and sedated in the ICU. It was at this point that another one of Mrs. George’s care team acted. Her daughter, who lives in another state, came back to the hospital when she heard her mom was giving up. I don’t think anyone else could have done what Mrs. George’s daughter did. Out of the love and special relationship they had, her daughter would not allow her mom to give up. As I write this, I am tearing up because of the power of authentic love for another human being that I witnessed. Over the next several days, Mrs. George became stronger. She requested less pain medication and participated in more physical therapy. She had hope and an understanding that the love of her daughter and the rest of us on her care team would not give up. About three months after her initial operation, she was discharged home. But soon after that, she needed a laparoscopic cholecystectomy, resulting in an additional week in the hospital. She finally is now home and recovering well.

In children’s hospitals and in hospice care, we often see authentic love. Why should we not show the same loving care for every person who is suffering a health problem? Peter Pronovost, MD, who is the head of the Armstrong Institute for Patient Safety at Johns Hopkins, is also one of the pioneers of clinical quality improvement applied to patient care. In his keynote talk at the Planetree Conference a few years ago, he told the audience what the key to patient safety and quality is. It is not a technology, like a

radiofrequency identification sponge system in the operating room, and it is not a strong group of managers implementing mandates and checklists. He said the key is found in loving our patients. I would only add that in order to do that, we need to design the system conditions that will allow our care teams to be in loving environments, facilitated by visionary leaders.

This is the last article in a series I have written about complexity science applied to health care [October, November and December 2013; March and April 2014].

You might notice that complexity science is not mentioned anywhere in this article.

You might think this last article is a bait and switch, just to get this touchy-feely subject published. If you think that, you are wrong. At the core of complexity science is the principle that all outputs of a complex system come from simple rules.

As human beings, we have the option to make choices based on two basic rules: Shall we act out of fear and defensiveness or out of love? These two basic responses actually come from different parts of our brain: fear from the amygdala of our lower brain, and love from our higher cognitive structures. When we react out of habit and defensiveness in response to stimuli

(read: “existing structure”), we behave in the way that Brene Brown found prevents us from living a wholehearted life. When we act motivated by authentic love, our actions can create different exciting lifegiving, long-term results. Imagine if we had the conditions in health care to regularly act out of authentic love.

—Dr. Ramshaw is chairman and — chief medical officer at Transformative Care Institute (nonprofit) and Surgical Momentum LLC (for profit), and codirector of Advanced Hernia Solutions, Daytona Beach, Fla.

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Use of Surgeon Extenders Continues To Grow in Value B Y E UGENE M URPHY , MD

W

ith increased pressure on providers to do more with less, how often do you seriously look around your operating room and ask yourself, “What can we be doing better?”

It is well understood that managing a multifacility operating room (OR) schedule can often be challenging.

With more than 30 years of experience as a general and vascular surgeon, I perform operations on Monday, Wednesday and Friday at St. Anthony‘s Health Care in St. Petersburg, Fla. In addition to Thursday afternoon procedures at BayFront, I handle on-call and emergency room admissions at St. Petersburg General, Northside and Ed White hospitals. In an average

week, I can perform more than 20 operations. With the high volume of cases that I take on at numerous worksites, it is very important to me that my staff is as consistent and efficient in the OR as possible.

As the aging population increases, the demand for surgical care will continue to grow. The Association of American Medical Colleges estimates that there will be a shortage of 91,500 doctors by 2020, and roughly half will be surgeons

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LAS VEGAS

Data show that on average, SFAs can reduce surgery time by 30% and increase surgeon throughput by 42%. and specialists, increasing the need for surgical efficiency.

With a looming staffing shortage, surgeons everywhere, including myself, are constantly looking for real-time solutions to increase case volume without sacrificing quality patient care. Over the past decade, more and more staffing models have emphasized the use of “physician extenders,” health care professionals who are licensed to practice medicine under the direction of physicians and surgeons.

In the OR, these qualified individuals are known as surgical first assistants (SFAs).

These “surgeon extenders” bring with them medical backgrounds, and represent physicians, surgeons, certified physician assistants and advanced registered nurse practitioners.

The best SFAs are specially trained in the latest surgical techniques and devices, so they can support the surgeon in many tasks throughout a broad range of procedures. Data show that on average, SFAs can reduce surgery time by 30% and increase surgeon throughput by 42% (Can J Surg 2010;53:103-108) 8 . This allows the surgeon to focus on the highest-value care activities and expedite the duration of surgery. Through the use of these specially trained SFAs, I have been able to increase both clinical and operational efficiencies, while providing high-quality surgical care.

Since 2008, I have used SFAs on close to 100% of my procedures. As an upshot of partnering with SFAs in the OR, I am

GSN Bulletin Board

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SURGICAL & WOUND CARE Harvard Medical School BETH ISRAEL DEACONESS MEDICAL CENTER DEPARTMENT OF SURGERY General/MIS Surgeons: The Division of General Surgery at Beth Israel Deaconess Medical Center invites applications and nominations for positions that will be available in the 2013-2015 academic years for general surgeons. Candidates must be Board-certified or Board-eligible in General Surgery. Candidates with fellowship training or special qualifications in advanced laparoscopy are preferred. Candidates must have a record of academic accomplishment in basic or clinical research, systems management, surgical education and/or simulation. The surgeon will have a primary responsibility of developing a network of community general surgical care in the state of the art BIDH-Needham affiliated Hospital, which is currently undergoing a major operating room expansion, located just miles west of Boston in the suburb of Needham. Secondary responsibilities may include teaching, clinical and/or basic research and patient care. Academic appointment at Harvard Medical School will be commensurate with experience and qualifications. The Beth Israel Deaconess Medical Center, a 600-bed tertiary and quaternary care hospital, is a member of BIDCO, LLC, a value-based physician and hospital network and an Accountable Care Organization (ACO). Beth Israel Deaconess Medical Center and Harvard Medical School are Equal Opportunity/Affirmative Action Employers. Women and minorities are particularly encouraged to apply. Inquiries, nominations, and applications should be directed in confidence, together with a current curriculum vitae and the names of at least four individuals from whom letters of reference may be solicited to: Mark P. Callery, M.D., FACS Chief, Division of General Surgery Beth Israel Deaconess Medical Center 330 Brookline Avenue, ST-928 Boston, MA 02215 Email: mcallery@bidmc.harvard.edu

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able to perform an average of 940 operations annually. In more than 5,000 cases in a five-year period, I increased my efficiency by an average of 46%. I also reduced my surgery time to 1.06 hours per case, as opposed to the national average of 2.3 hours per case. (Data are based on surgery time for Healthcare Common Procedure Coding System codes related to procedure area, and derived from adding specific intraoperative activities that research has shown to reduce surgery time when taken over by SFAs.) As a result, my

patients spend less time under anesthesia and more time in recovery, and I am able to add cases at the same time.

Working with SFAs has enabled me to be more focused on what I am good at and increase the number of procedures that I can do in a normal workweek. The SFAs are so much more than helpers in the OR; they truly are partners who help accomplish what we are here for in a shorter amount of time. Ultimately, this is all done with fewer resources, saving my facilities money.

Bringing SFAs into your OR isn’t going to be the only answer to the complicated situation of a growing aging population and a potential shortage of providers, but I firmly believe that the specialization of qualified, reimbursable clinical labor can optimize surgeon involvement, improve patient experiences and reduce OR costs.

SFAs who are trained in the latest surgical techniques and technologies, in addition to OR management, are emerging as a solid solution that not only benefits the surgeon’s work, but also are a positive solution for the organization as a whole.

—Dr. Murphy is a board-certified — general and vascular surgeon at Tampa Bay Area’s Suncoast Medical Clinic, owned

by St. Anthony’s Health Care.

Dr. Murphy reported that he has no relevant financial conflicts of interest.

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position For classified advertising: contact Nancy Parker 917 715 1147 nparker@mcmahonmed.com

21

22

In the News VENOUS THROMBOEMBOLISM jContinued from page 13 a telephone interview.

He pointed to research from his department and the University Health Consortium, showing that deep vein thrombosis and pulmonary embolism occur rarely after major elective surgery, around or below 1%. Moreover, VTEs rates failed to improve after widespread implementation of the 2004 guidelines calling for more pharmacologic prophylaxis of VTE

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / JULY/AUGUST 2014

((Ann Surg 2011;253:215-220). â&#x20AC;&#x153;Industry has funded studies that overestimate the true VTE rate, and that has put the focus on potential hazardous prophylaxis and less on the clinical significance of VTEâ&#x20AC;Ś So weâ&#x20AC;&#x2122;re not focusing on the right thing, and these types of quality measures arenâ&#x20AC;&#x2122;t going improve quality in hospitals. This is the wrong target.â&#x20AC;?

This study suggested that certain hospital characteristics are associated with higher rates of VTE imaging. The characteristics included teaching intensity at a hospital and accreditations such as that of the Joint Commission. Other

significant drivers included a hospitalâ&#x20AC;&#x2122;s medicolegal risk environment according to CMS malpractice geographic practice cost index, and greater hospital market competition.

Hospitals that used VTE imaging more often were also those most likely to adhere to Surgical Care Improvement Projectâ&#x20AC;&#x2122;s VTE prophylaxis guidelines.

This may reflect an assumption that increased imaging intensity is associated with better quality, Dr. Ju said.

In this study, VTE imaging use rates were calculated from Medicare claims, and VTE prophylaxis adherence data were

obtained from CMSâ&#x20AC;&#x2122; Hospital Compare.

Hospitals showed considerable variation in VTE imaging, with a threefold increase from the lowest quartile at 5.3%, to 16% in the highest quartile.

The authors acknowledged that the study had limitations, because it only examined ACS NSQIP hospitals and inpatient VTE imaging use rates were for Medicare patients.

This year marked the 134th annual meeting of the American Surgical Association. Established in 1880, the American Surgical Association is the oldest surgical association in the United States.

Letter Screening Mammography

Rationale, Reversal, and Recovery Of Neuromuscular Blockade Part 2: Ongoing Challenges and Opportunities Case Study Dennis is a 68-year-old man undergoing open abdominal surgery (colectomy).

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

Global Education Group and Applied Clinical Education are pleased to introduce part 2 of a 3-part interactive CME series featuring challenging cases in NMB. Each activity presents a clinical scenario that you face in your daily practice. After reading the introduction to the case, consider the challenge questions, and then visit ZZZ &0(=RQH FRP QPE WR ÂżQG out how your answers stack up against those of our multidisciplinary faculty panel.

Access the activities on your desktop, laptop, or tablet to explore the issues surrounding safe, effective, NMB reversal via a unique multimedia learning experience and earn 1.0 AMA PRA Category 1 Credit.â&#x201E;˘ Complete the whole series and earn a total of 3.0 AMA PRA Category 1 Credits.â&#x201E;˘ This activityâ&#x20AC;&#x2122;s distinguished faculty

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

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

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

Medical Director, Manager New Medical Center Nancy, France

Access this activity at ZZZ FPH]RQH FRP QPE

This activity is jointly sponsored by Global Education Group and Applied Clinical Education.

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To the Editor: I read Dr. Greeneâ&#x20AC;&#x2122;s article on mammographic screening and I agree we have created a screening dilemma [ June 2014, page 1]. If one looks up the definition of a screening test, there is no mention that the test will reduce the mortality of the disease. However, this continues to be the focus of all articles on mammographic screening! By definition, a screening test should be done for a common disease, it should be easily performed, it needs to be accepted by the public, it should find disease earlier than in those patients who are not screened, and it should result in less radical treatment and a better prognosis for those patients screened. I believe the mammogram does all of these things.

There are harmful effects of any screening test and the mammogram is no exception. One such argument is that there has been an increase in the diagnosis of DCIS [ductal carcinoma in situ] and that many of these patients are being overtreated because many of these cases would never have become clinically evident without the use of mammography.

The truth of the matter is that until we can determine which patients would not develop clinically apparent disease, all of these patients need to be treated for DCIS. The other major harmful effect is the false-positive test. Many women have the stress and anxiety of having to endure a biopsy for a benign process. However, there is no way to measure the stress and anxiety of women who elect not to be screened. I agree with the European studies that show a 30% overall reduction in mortality for breast cancer with screening mammography, and hopefully with the use of digital and threedimensional mammography this will be increased.

John Cunningham, MD Berkeley Heights, N.J.

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