Jan 2015

CONVENTION ISSUE:

Society of Critical Care Medicine

GENERALSURGERYNEWS.COM

January 2015 • Volume 42 • Number 1

The Independent Monthly Newspaper for the General Surgeon

Opinion

No Amnesty for the Affordable Care Act

Ethics and the Robot Should Costs Be Discussed With Patients?

B Y C HRISTINA F RANGOU

Bariatric Surgery Costs Recouped With Reduced Meds B Y K ATE O’R OURKE

B Y D AVID V. C OSSMAN , MD

I

was watching President Obama’s “amnesty” speech the other night and I began to understand the Affordable Care Act (ACA).

The goals of health care reform, setting aside cost control, always seemed straightforward to me: Provide care and coverage for the uninsured, end the practice of cancelling insurance for those who need it the most because they were sick and consumed a lot of resources, and provide coverage for people with “pre-existing conditions.” Addressing these issues that affect maybe 40 million people could have been accomplished in a bipartisan way without disturbing the other 300 million Americans, which was the pledge.

The reasons for the lack of clarity in the massive actual law are starting to come into focus through a coalescence of events. Nancy Pelosi’s famous observation after the bill’s passage that we would all have to “wait to see what was in it” before deciding if we liked it or not now seems

SAN FRANCISCO—In West’s “Encyclopedia of American Law” (2008 edition), “informed consent” is defined as: Assent to permit an occurrence, such as surgery, that is based on a complete disclosure of facts needed to make the decision intelligently, such as knowledge of the risks entailed or alternatives.

But what facts do patients need to make the decision intelligently? Should a complete disclosure of facts include all the costs associated with a surgical procedure? Is cost relevant when a patient is paying for the surgery but not relevant when an insurance company is footing

provide more genetic testing and counseling, offer selective neoadjuvant hormone therapy and work more closely with specialists from other disciplines.

In a standing room–only lecture hall at the 2014 Clinical Congress of

BO OSTON—Obese patients who undergoo laparoscopic bariatric surgery use significantly fewer medications in tthe long term than those who do not have the surgery, according to an analysis of national insurance claims. The yearly savings in prescription drug costs four years after ssurgery was $1,500.

“The decreased rate of prescription escription dru ug utilization over four yearrs amoong patients who underwen nt surggery compared to those in n the nonsurgery cohort mayy be due to an improvement in n comorbid burden post-sur-gery,” said John Morton, MD,, president of the American Society for Metabolic and Bariatric Surgery (ASBMS) and director of bariatric surgery at Stanford University School of Medicine, in Stanford, d C Calif. lif Dr. Morton presented the study at Obesity Week 2014 (abstract a103).

Previous research examining the effect of bariatric surgery on health care costs has been mixed. An employer claims database study conducted between 1999 and 2005 estimated the cost of bariatric surgery to be between $17,000 and $26,000, and concluded that downstream savings offset initial costs in two to four years (Am ( J Manag Caree 2008;14:589-596).

see BREAST CANCER page 28

see BARIATRIC COSTS page 34

the bill? And what should surgeons say to potential patients about costs associated with new technologies, such as robotic surgery?

These questions were discussed at see ETHICS AND ROBOT page 32

Experts Discuss Major Advances in Breast Cancer, Make Recommendations Margins, Axillary Dissection, Intra-op Radiotherapy, Genetics

see AMNESTY FOR ACA page 37

B Y C HRISTINA F RANGOU

REPORT Enhanced Recovery Pathways for Major Abdominal Surgery See insert at page 20

SAN FRANCISCO—What’s new in breast cancer surgery for 2015?

According to leading breast cancer specialists, surgeons will perform fewer axillary lymph node dissections,

INSIDE In the News

Surgeons’ Lounge

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Hernia Repair: How Pushing Patient Accountability Can Improve Outcomes

Readers Diagnose Patient With Symptomatic Umbilical Hernia Who Experiences Post-op Complications

In the News General Surgery News Now Offers Video Coverage See page 9

GSN Editorial

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / JANUARY 2015

Making the Most of the Fourth Year Frederick L. Greene, MD, FACS Clinical Professor of Surgery UNC School of Medicine Chapel Hill, North Carolina

D

uring the many years that I have had the pleasure of serving as a surgical program director and participating in the interview process to select candidates for surgical training, it has become apparent that the fourth year of medical school is a great wasteland that is not being used effectively and, in many cases, does not justify the tuition paid by students, parents or others! In fact, the fourth year usually concludes for most medical students around late March or in April, leaving a spectacular amount of time before graduation for other pursuits such as travel, working to pay off medical school loans or simply spending time with one’s friends or family.

Don’t get me wrong: These are important activities. Relaxing and refreshing oneself before the arduous start of surgical residency has merit. It seems, however, that some aliquot of this waning time could be spent preparing for the basic

skills needed to begin surgical training that would allow all matriculants to begin with the same approximate level of technical expertise. I was delighted, therefore, to learn that finally some collective recommendations have been offered to prepare surgical trainees while they are still medical students.

The American Board of Surgery (ABS), the American College of Surgeons (ACS), the Association of Program Directors in Surgery (APDS) and the Association for Surgical Education (ASE) have now banded together to support and elucidate a concept embracing surgical residency preparatory courses ((Am J Surgg 2014;208:695). The concept is that these courses will give basic instruction to all those who will be entering a surgical program to help reduce both the technical and knowledge-based disparities that exist among residents. In view of the detrimental effects of reduced opportunities for learning promulgated by work-hour restrictions, especially in the first year of surgical training, it makes eminent sense to use time in the fourth year of medical school that has been

e-Book Now Available Lost Lessons From the M&M Conference What You Should Have Learned but Didn’t

By Leo A Gordon, MD Much of clinical surgery is passed on as an oral tradition. Despite all efforts, most lessons voiced at the Morbidity and Mortality Conference die at the door. The insights of the operating room, ward rounds and surgeons’ lounges disappear.

The essential practical lessons of clinical surgery are not covered in the standard texts.

In a collection of 100 pithy and insightful essays, a master surgical educator codifies and memorializes those lessons—lessons learned the hard way—through experience.

Celebrating its 10th anniversary “Cut to the Chase: 100 Matrix Pearls for Doctors” is now available as a Google e-book.

Search “Cut to the Chase” at: http://books.google.com/

see FOURTH YEAR page 4

Mission Statement

Sales

Senior Medical Adviser

Michael Goldfarb, MD

J. Barry McKernan, MD

Frederick L. Greene, MD

Long Branch, NJ

Marietta, GA

Charlotte, NC

Leo A. Gordon, MD

Joseph B. Petelin, MD

Los Angeles, CA

Shawnee Mission, KS

Gary Hoffman, MD

Richard Peterson, MD

Los Angeles, CA

San Antonio, TX

Namir Katkhouda, MD

Joseph J. Pietrafitta, MD

Los Angeles, CA

Minneapolis, MN

Jarrod Kaufman, MD

David M. Reed, MD

Freehold, NJ

New Canaan, CT

Michael Kavic, MD

Barry A. Salky, MD

Youngstown, OH

New York, NY

Peter K. Kim, MD

Paul Alan Wetter, MD

Bronx, NY

Miami, FL

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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GSN Editorial

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / JANUARY 2015

FOURTH YEAR

I will go out on a limb and suggest that we will observe important outcomes from these experiences, bringing the skills of incoming residents closer to the goals and objectives of residency supervision outlined by the Accreditation Council on Graduate Medical Education.

jContinued from page 3 traditionally underutilized by most students.

Specifically, the ACS, the APDS and the ASE have created a Resident Prep Curriculum that includes many of the skills expected by surgical program directors as benchmarks for success in the first year of surgical residency training. The plan is to offer this at U.S. medical schools, and, thus far, 39 institutions in 2014 and

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© 2014 Vector Surgical, LLC ZĞĨĞƌĞŶĐĞƐ͗ ŚĂŶĚ͕ E͖͘ ĞƌƚƐƐĞŶ͕ ͖͘ ĂŶĚ ZŽLJůĞ͕ '͘ ͞ džŝůůĂƌLJ ͚ džĐůƵƐŝŽŶ͛ Ͷ ^ƵĐĐĞƐƐĨƵů dĞĐŚŶŝƋƵĞ ĨŽƌ ZĞĚƵĐŝŶŐ ^ĞƌŽŵĂ &ŽƌŵĂƟ ŽŶ Ō Ğƌ DĂƐƚĞĐƚŽŵLJ ĂŶĚ džŝůůĂƌLJ ŝƐƐĞĐƟ ŽŶ͘͟ Advances in Breast Cancer Research 2 ;ϮϬϭϯͿ͗ ϭͲϲ͖ ŚĂƌŵĂǁĂŶ͕ Z͖͘ EĂŐĂůŝŶŐĂŵ͕ ^͖͘ dĂLJ͕ >͘​͖͘ tŽŶŐ͕ ͖͘ ĂŶĚ dĂŶ͕ ͘ ͞dŚĞ hƐĞ ŽĨ ŽŵƉƌĞƐƐŝŽŶ Ğůƚ ŝŶ ƚŚĞ WƌĞǀĞŶƟ ŽŶ ŽĨ ^ĞƌŽŵĂ &ŽƌŵĂƟ ŽŶ WŽƐƚͲ ƌĞĂƐƚ ĂŶĐĞƌ ^ƵƌŐĞƌLJ͗ ZĂŶĚŽŵŝnjĞĚ dƌŝĂů͘͟ WŽƐƚĞƌ ƐĞƐƐŝŽŶ ƉƌĞƐĞŶƚĞĚ Ăƚ͗ DŝůĂŶ ƌĞĂƐƚ ĂŶĐĞƌ ŽŶĨĞƌĞŶĐĞ͖ ϮϬϭϯ :ƵŶĞ ϮϬͲϮϭ͖ DŝůĂŶ͕ /ƚĂůLJ͖ <ŽŶƚŽƐ͕ D͖͘ WĞƚƌŽƵ͕ ͖͘ WƌĂƐƐĂƐ͕ ͖͘ dƐŝŐƌŝƐ͕ ͖͘ ZŽLJ͕ W͖͘ dƌĂĨĂůŝƐ͕ ͖͘ ĂƐƚŽƵŶŝƐ͕ ͖͘ ĂŶĚ <ĂƌĂŵĂŶĂŬŽƐ͕ W͘ ͞WƌĞƐƐƵƌĞ ƌĞƐƐŝŶŐ ŝŶ ƌĞĂƐƚ ^ƵƌŐĞƌLJ͗ /Ɛ dŚŝƐ ƚŚĞ ^ŽůƵƟ ŽŶ ĨŽƌ ^ĞƌŽŵĂ &ŽƌŵĂƟ ŽŶ͍͟ Journal of B.U.ON. 13.1 (2008): 65-67.

55 medical schools in 2015 have agreed to introduce this curriculum. Obviously, we will need to wait several years to judge adequately whether these preparatory experiences will be meaningful to trainees and instructors. I will go out on a limb, however, and suggest that we will observe important outcomes from these experiences, bringing the skills of incoming residents closer to the goals and objectives of residency supervision outlined by the Accreditation Council on Graduate Medical Education.

Unfortunately, these opportunities may not be available to all neophyte surgical residents, because approximately 20% of the trainees in U.S. programs matriculate from international or non-allopathic medical schools. Additional challenges may be the cost of hosting these modular curricula and recruiting faculty associated with medical schools to serve as instructors. I believe, however, that once the benefits of a pre-residency basic learning experience become recognized, it will be imperative for all medical schools to offer these experiences to their future surgical alums.

The current large lacunae in the fourth year of medical school could be filled with other beneficial pre-training opportunities. The programs Fundamentals of Laparoscopic Surgery (FLS) and Fundamental Use of Surgical Energy (FUSE), created by the Society of American Gastrointestinal and Endoscopic Surgeons, would be appropriate to introduce into these curricula. Inherently important in any of these preparatory strategies is the great opportunity to introduce a cohesive approach to communication skills, surgical ethical dilemmas and perioperative care paths that the surgical house officer will face as he or she matriculates into graduate training. This will indeed be time well spent and will make the fourth year of medical school more robust, ensuring a smoother transition to a surgical career in 2015 and for many decades to come.

Happy New Year!

In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / JANUARY 2015

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Noncardiac Perioperative Risk Factors in Elderly Mapped B Y M ICHAEL V LESSIDES New Orleans—Patients older than 80 years have been found to do well after noncardiac surgery, with surprisingly few complications, according to a study from Japan. However, there are several factors that predict postoperative adverse events, including preoperative hypoalbuminemia, intraoperative blood transfusion, longer operative time and male gender.

“The average life span has been rapidly increasing around the world,” commented Yoshinori Muto, MD, a senior resident at the University of Tokyo Hospital, in Japan. “Meanwhile, the volume of surgery for the elderly has also increased. As such, the aim of this study was to investigate the perioperative risk factors that predict 30-day postoperative complications in elderly patients who undergo noncardiac surgery.”

Dr. Muto and his colleagues identified 334 patients at least 80 years of age, who underwent noncardiac surgery under general anesthesia at his institution between January and December 2013. Several preoperative and intraoperative variables were recorded, including demographic data, anesthetic management, type of surgery, and preoperative comorbidities using the Charlson Comorbidity Index (CCI) score. The primary composite outcome was 30-day postoperative complications, including death, cardiac adverse events (heart failure, ischemic heart disease or atrial fibrillation), pneumonia and other infections, cerebrovascular disease and deep venous thrombosis/pulmonary embolism.

The 334 patients had a mean age of 82.9 years; slightly more than half (51.2%) were men. Abdominal surgery was performed in 121 patients (36.2%). “The most common comorbidity we found was moderate or severe renal disease, followed by tumor without metastasis,” Dr. Muto said. The mean CCI score was 3.6, he added.

As Dr. Muto reported at the 2014 annual meeting of the American Society of Anesthesiologists (abstract A1240), 30-day postoperative complications occurred in 91 patients (27.2%), including one death. Multiple logistic regression analysis revealed that four factors were associated with the development of postoperative complications: preoperative serum albumin concentration <3.5 g/mL (odds ratio [OR], 2.65; 95% confidence interval [CI], 1.53-4.61; P<0.001); intraoperative blood transfusion (OR, 4.45; 95% CI, 1.96-10.10; P<0.001); operative time ≥120 minutes (OR, 3.11; 95% CI, 1.68-5.74; P<0.001) and male gender (OR, 1.97; 95% CI, 1.15-3.37; P=0.014).

P “We found it surprising that hypoalbuminemia was a predicting factor for

postoperative complications, whereas age and Charlson Comorbidity score were not, because there are so many reports that preoperative performance status is a predicting factor,” Dr. Muto said. “This may mean that nutritional condition was more important in the acute postoperative phase in elderly

patients than age or preoperative comorbidities.

“Secondly, transfusion during surgery and longer operation time were identified as predicting factors,” he added. “This indicates that operative stress that requires intraoperative transfusion is more important than preoperative anemia. These results may help predict postoperative

outcomes, but further research is also required to evaluate other factors.”

Gwendolyn L. Boyd, MD, professor and medical director of anesthesiology at the University of Alabama at Birmingham, lauded the researchers for their efforts.

Indeed, she noted the importance of the study for a variety of health care specialists.

“This topic is an important one for anesthesiologists, surgeons and health care policy makers to know about,” she told General Surgery News.

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

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In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / JANUARY 2015

Hernia Repair: How Pushing Patient Accountability Can Improve Outcomes Experts Offer Practical, Inexpensive Tips on How To Optimize Outcomes B Y M ONICA J. S MITH WASHINGTON—Achieving success in hernia surgery depends on all stakeholders involved—surgeons, caregivers and patients—and the latter need to be educated on what factors they bring that

may influence outcomes, said Adrian A. Park, MD, who discussed the topic at the 2014 Abdominal Wall Reconstruction Conference.

“With knowledge comes responsibility, so I’d like to focus on the need for patient engagement,” said Dr. Park, chair of the Department of Surgery at Anne Arundel Medical Center, in Annapolis, Md. “Historically, we’ve thought the surgeon glides into the room, does this wonderful surgery and that leads to terrific

outcomes. While I would by no means want to diminish the importance of a skillful surgical intervention, in many areas we recognize that, without patient engagement, surgery alone is responsible for 50% to 60% of the outcomes we want to see.”

He gave the example of bariatric surgery, where patients need to engage preoperatively and demonstrate their determination and dedication to a program that will help them get the best results out

of their procedure.

“Our bariatric colleagues have shown what setting milestones, and to varying degrees, rigorous compliance requirements, can do to affect the outcomes. So I want to take more of that tack as we look at this,” Dr. Park said.

Sharing the Reins Patients approaching hernia surgery who hand over full responsibility to the surgeon often end up with poor outcomes, Dr. Park said.

When patients balk at making difficult or uncomfortable changes, surgeons need to find a way to say, “I can’t care more about this than you do,” Dr. Park said. “I’ve had to explain at times that it would be less than responsible of me to proceed with surgery if nothing changes at the patient’s end.”

It is not only patients, however, who need to adjust their view of responsibility. Getting patients engaged requires a bit of a mental shift by the surgeon as well.

“Unique from most medical doctors, surgeons tend to have an internal locus of control. They feel that the buck stops with them: ‘I’ve got to fix this patient.’ We’ve got to learn that we can’t always do that,” Dr. Park said. (See related story, “U.S. Panel of Surgeons Says ‘No’ to Noncompliant Hernia Patients,” GSN, N September 2014, page 1.)

The list of factors that patients can potentially control will be familiar to surgeons: Obesity unquestionably affects the occurrence and recurrence of hernias; smoking increases the risk for hernia formation fourfold; and poor glucose control hinders wound healing and increases the risk for surgical site infections.

As direct as these factors may be, they are neither easy nor simple to modify, and addressing them involves some of the most challenging conversations that a doctor can have with a patient. “You’re asking patients to do some of the most difficult things we ask patients to do,” Dr. Park said. “But there comes a point when the patient is totally fed up with their current situation and they can start to get serious about it.”

In the Patient’s Hands, With Surgeon’s Guidance Smoking cessation and weight loss are the two most well-recognized factors that patients alone control. But there are other factors that they and their doctors can address in the perioperative setting.

Achieving good glucose control, for example, in the months leading up to surgery is

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GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / JANUARY 2015

important, but patients may not be aware that the stress of surgery can cause their glucose levels to skyrocket in the critical hours after surgery.

“The mold of wound healing is set in the first 24 hours. When you close an incision, proteins ooze into that tissue, and if the blood sugars there are at 250, that’s just more fuel for the bacteria to metabolize,” said Robert D. Martindale, MD, PhD, professor of surgery and chief of general surgery, Oregon Health & Science University, in Portland.

But given the fact the patients have not eaten since the night before surgery, they often erroneously assume they will not be hyperglycemic, and blood sugar may be the last thing on their minds. “Most patients won’t even check it,” Dr. Martindale said. “That’s an education piece we really need to get across to them.”

Not all optimization approaches require major lifestyle changes or big efforts by the patient. Carbohydrate loading may help set up patients for better outcomes.

“That’s a new concept that’s becoming more accepted,” Dr. Martindale said.

“When patients are NPO [nothing by mouth] the night before, they begin the surgery with no glycogen stores. Without glycogen to use as fuel, the body turns to muscle or fat. But the stress of surgery drives insulin resistance, which shuts down the body’s ability to optimally burn fat, so it turns to protein—which is the very thing we want to protect in the postoperative setting—as a fuel substrate.”

Consumption of a preoperative, isotonic oral solution, of which there are several commercially available, can help support the body’s energy needs during surgery and spare the patient’s lean tissues, Dr. Martindale said.

In high-risk patients, the preoperative application of mupirocin and chlorhexidine can lower the risk for infection considerably. “We put the antibiotic in their nose twice a day and give them the chlorhexidine wash to use once a day for five days before the surgery,” Dr. Martindale said.

In the largest paper to date, an intentto-treat analysis that followed 6,771 patients, this preoperative treatment lowered Staphylococcus aureuss by 44% (N Engl J Medd 2010;362:9-17). The antibiotic and wash together cost about $4.

Another simple thing that patients can do in the five days before surgery is to consume a preoperative metabolic modulating formula with arginine and fish oil,

which has been shown to correlate with decreases in infection and hospital length of stay across all surgical specialties ((J Am Coll Surg 2011;212:385-399).

Turning to a more long-term, patientinvolved approach to optimizing surgical outcomes is a relatively new concept on the horizon: prehabilitation. “This is an individualized exercise and nutrition plan to prepare patients for surgery,” Dr. Martindale said.

On the day the decision is made to schedule a major surgery in Dr. Martindale’s practice, patients meet with a physical therapist and a dietitian to set up a

When patients reach a point where they insist on surgery, it needs to be clear to both parties that even though the patient knows there may be great risk, he or she thinks the potential benefit outweighs any risk he or she understands the surgery carries.

plan, then with the surgeon again.

“We look them in the eye and say, ‘I fully support this plan they have made for you; it has been shown to work in thousands of patients,’” he said. “They need to know there is 100% support by the health care community—and this works.”

The Conversation Continues In addition to informing patients of what they can do to help themselves, surgeons need to ensure that patients understand the role that their innate biology plays—if they have an acquired see ACCOUNTABILITY page 8

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In the News ACCOUNTABILITY jcontinued from page 7

predisposition or susceptibility to hernia formation and recurrence—and how that may influence outcomes.

At this point, the informed consent discussion shifts from the various stakeholders’ accountabilities to identifying where the surgery falls in the risk–benefit ratio.

“If they’ve had multiple operations and there is risk of a bowel injury at the time of surgery to correct a small or minimally uncomfortable hernia, the discussion

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / JANUARY 2015

goes toward explaining that the potential risks may outweigh the benefit,” Dr. Park said.

When patients reach a point where they insist on surgery, it needs to be clear to both parties that while the patient knows there may be great risk, he or she thinks the potential benefit outweighs any risk he or she understands the surgery carries.

Other stakeholders, too, need to be engaged in the discussion of accountability and informed consent. “Family members involved in their care have a huge role in deciding how things go forward,

‘Surgeons tend to have an internal locus of control.

They feel that the buck stops with them: “I’ve got to fix this patient.” We’ve got to learn that we can’t always do that.’

—Adrian A. Park, MD

and they need to be informed,” Dr. Park said. “These are, in some ways, more grown-up discussions than we’ve had with patients in the past.”

In conclusion, he said, the accountability to optimize factors that lead to the greatest value and best outcomes for hernia patients is shared by patients, their surgeons and caregivers. “Our challenge is to meaningfully define, implement and measure the impact of acting upon these factors, and then repeat that cycle on a very regular basis,” Dr. Park said. “That, essentially, is what continuous quality improvement is.”

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In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / JANUARY 2015

Inpatient Falls Are Up But Don’t Blame the Epidural, Study Shows

BY MICHAEL VLESSIDES New Orleans—Although inpatient accidents and falls increased substantially during admissions for thoracic and major abdominal surgeries between 2007 and 2011, epidural analgesia is not one of the causes of those falls, according to an analysis.

“It often seems like surgeons have several reasons to have us avoid epidurals,

including, more recently, the possibility of patient falls,” said Tiffany M. Williams, MD, PhD, a resident at the University of Texas Southwestern Medical Center, in Dallas. “And yet there are countless studies that demonstrate the benefits of neuraxial blocks, including decreased blood loss during cases, superior analgesia compared to oral or IV medications, decreased length of stay, and reduced morbidity and mortality.

“We wanted to see what was true: Are

patients really falling more with neuraxial blocks? And if we can show data that demonstrate this is actually not the case, then we can bolster our argument for neuraxial analgesia when we’re talking to surgeons and be advocates for our patients.”

Given that inpatient accidents and falls can lead to increased morbidity, prolonged disability and even mortality, Dr. Williams and her colleagues examined data from the Nationwide Inpatient Sample (NIS) to identify adults who underwent elective

Next stop: G GeneralSurgeryNews.com Ge eneralS u r g e r y N e w s . c o m Your Grand Central Station for all the latest new ws, opinions and analysis in surgery.

thoracic or major upper abdominal surgery. Cardiac, transplant, trauma, laparoscopic, emergent and robot-assisted cases were excluded.

“Since there is no specific ICD-9 [International Classification of Diseases, ninth revision] code for inpatient falls, we used inpatient accidents as our proxy,” Dr. Williams said. Univariate analysis was used to assess the unadjusted fall rate, and multiple logistic regression analyses were conducted to investigate the independent association between postoperative epidural analgesia and falls.

As reported at the 2014 annual meeting of the American Society of Anesthesiologists (abstract A2137), Dr. Williams said 36,595 thoracic and 25,537 major upper abdominal surgical cases were identified. The overall incidence of falls was 6.6% among patients in the thoracic surgery group. The rate of falls among these individuals increased from 4.8% in 2007 to 8.5% in 2011 (P<0.0001).

Similarly, the incidence of falls after upper abdominal surgery was found to be 6.3%. There was an increasing trend between 2007 (4.5%) and 2011 (8.1%; P<0.0001).

“When we pulled out the data and looked at the group that received epidurals and the group that did not, there was actually no association with respect to falls in those patients,” Dr. Williams said. Logistic regression analysis revealed an odds ratio of 0.96 (95% confidence interval [CI], 0.81-1.15; P P=0.68) for falls in thoracic patients undergoing epidural analgesia, compared with 1.11 (95% CI, 0.88-1.41; P=0.34) in the upper abdominal group.

P “If you had an epidural, you didn’t fall any more frequently than a patient who didn’t have an epidural,” she said. “So, there’s some other factor that we’re not able to identify now that’s contributing to patient falls. But it’s not the epidural.”

Session moderator Satya Krishna Ramachandran, MD, assistant professor of anesthesiology at the University of Michigan Health System, in Ann Arbor, found the study interesting. “My sense of patients who fall is that they are frailer, usually with more significant disease or more significant comorbid conditions,” he said. “So, my suggestion is to redo this analysis using propensity scores, dividing the study cohort into those that fell or didn’t fall, and then looking at whether or not the epidural rates are significantly different between the groups.

“That’s as close as you can get to a good control,” Dr. Ramachandran continued. “Logistic regression analyses are very convenient, but they often don’t provide us with adequate control in this sort of outcome analysis.”

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GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / JANUARY 2015

C. difficile Infection Takes Bigger Toll in Elderly B Y M ONICA J. S MITH PHILADELPHIA A—One of the challenges in managing patients infected with Clostridium difficilee is identifying those most at risk for dying of the disease and treating them appropriately.

New research adds to mounting evidence that advanced age is a significant predictor of death from C. difficilee infection (CDI), tripling a patients risk for mortality compared with that in younger patients.

“The conundrum of this infection is that treatment is based on severity,” said Sahil Khanna, MD, assistant professor of medicine at Mayo Clinic in Rochester, Minn. “If you have mild or moderate disease, you get treated with metronidazole.

If you have severe disease, you get treated with vancomycin.”

The American College of Gastroenterology (ACG) defines severe disease as CDI in patients with albumin below 3 g/dL, and either white blood count of at least 15,000 cells/mm3 or abdominal tenderness.

“We wanted to see if there were other markers that could [identify] severity, and the first step in doing that was to study an end point for severe infection, which in our study was mortality,” Dr. Khanna said. “We wanted to evaluate what predicts mortality in patients with CDI, and whether some factors are more predictive than others.”

Dr. Khanna and his colleague, Darrell Pardi, MD, professor of medicine at Mayo, evaluated data from the National Hospital Discharge Survey. “We looked at all the hospitalized patients with CDI and compared CDI patients who died with those who didn’t die, and tried to identify factors that predict in-hospital mortality in hospitalized CDI patients,” Dr. Khanna said.

The survey included an estimated 162 million adults between 2005 and 2009, of whom 1.26 million had CDI. All-cause mortality of hospitalized patients with CDI was 6.9% compared with 2.2% for hospitalized patients without CDI. “We can’t say they died of CDI, just that they had CDI and also died in the hospital,” Dr. Khanna noted.

The most prominent factor the researchers observed associated with CDI and mortality was increased age. “The older people were, the more likely their chance of dying. So we dichotomized people into two age groups: from 18 to 64 and 65 and older,” Dr. Khanna said.

“On univariate analysis, not considering other factors, people who were older had a threefold higher risk for dying of CDI than younger people. That was striking.”

Several other factors stood out as well, such as undergoing colectomy, and certain comorbidities—congestive heart failure, pulmonary circulation disorders, metastatic cancer, electrolyte disorders and weight loss—were associated with a significantly higher risk for death.

“Our conclusion is that age should be factored into assessment of severity, and people older than 65 should be considered to have severe disease and possibly managed with vancomycin rather than

metronidazole. Of course, future studies will need to investigate this in clinical practice; this was a retrospective study and mostly hypothesis-generating.”

Dr. Khanna presented the research at the ACG’s 2014 annual meeting (poster P1644).

Neil Gupta, MD, MPH, assistant professor of medicine and director of interventional endoscopy at Loyola University Medical Center, in Maywood, Ill., agreed that age should be considered when trying

to predict disease severity and therapy.

“However, I would be more forward regarding the implications of the study results,” Dr. Gupta added. “This study actually adds to a growing body of literature showing that older age is associated with higher mortality in patients with CDI. As a result, this study confirms the results of prior studies, and clinicians should start considering patient age when managing CDI if they are not doing so already.”

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Surgeons’ Lounge

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / JANUARY 2015

Welcome to the January issue of The Surgeons’ Lounge. I hope all our readers had safe and happy holidays, and are ready for another exciting year of questions, comments and challenges for our guest experts. We are starting this year by featuring our readers as our guest experts in Be our next expert!! Jorge Daes, MD, general surgeon, Universidad Javeriana, Bogota, Colombia, subspecialist in advanced laparoscopic surgery, Universidad CES, Medellin, Colombia, chief, Minimally Invasive and Bariatric Surgery Department at Clinica Bautista, Barranquilla, Colombia and a leading author of several original articles on eTEP hernia repair, seroma prevention in large inguinoscrotal hernia and subcutaneous endoscopic component separation, was the first to respond and is our guest expert. We also included two other responses from our readers that we felt were worth reading.

Also, check out the reply to the Surgeon’s Challenge: How did you do?

We welcome your questions and comments and looking forward to another great year!

Sincerely, Samuel Szomstein, MD, FACS Editor, the Surgeon’s Lounge Szomsts@ccf.orgg

Surgeon’s Challenge From December 2014 Case prepared in collaboration with Jacqueline Wilneff, MD candidate, Class of 2016, Charles E. Schmidt College of Medicine, Florida Atlantic University, Boca Raton

A

66-year-old woman with a past medical history significant for a 40 pack-year smoking habit with chronic obstructive pulmonary disease, hypertension and diabetes mellitus, presented to our clinic with a recurrent ventral hernia and nonhealing midline wound. Her past surgical history includes cholecystectomy, exploratory laparotomy for perforated diverticulitis with colostomy that required a prolonged ICU stay, tracheostomy and posterior reversal of colostomy.

The patient had undergone three previous ventral hernia repairs, with the last repair for recurrence six months before presenting to our clinic. She reported fatigue and significant weight gain, but denied nausea or vomiting, abdominal pain or change in bowel habit.

Her vital signs were within normal limits, and she had a body mass index of 29.28 kg/m2. Abdominal examination revealed multiple scars, midline exposed mesh and active secretion of purulent material without erythema.

Multiple hernia defects were noted (see below). Laboratory test results were within normal limits.

How would you manage this patient?

Reply to Challenge After informed consent was obtained, the patient was brought into the operating room and placed on the operating table in a supine position. After induction of anesthesia and successful endotracheal intubation, the abdominal wall was prepped and draped in the standard fashion.

A longitudinal incision was performed in the supraumbilical area in a median position over the previous laparotomy scar; the areas of skin with eroded infected mesh were excised with the skin. The subcutaneous tissue was divided with electrocautery, and the previously placed mesh was carefully dissected from the hernia ring and adhesions to the omentum and small and large bowel structures.

Of note, the patient had a previous left side colostomy and a previously opened cholecystectomy on the right side. A small recurrence from the previous colostomy was identified and was closed, and all mesh was removed including the eroded portions into the skin (Figure 1). All prolene sutures were also removed.

At this point, it appeared that a component separation was necessary for optimal closure of the abdomen.

The external oblique and rectus muscles were separated and elevated all the way up to the rib cage, allowing for medialization of the rectus muscle. A 20×16 cm biologic mesh was then introduced intraabdominally and secured with running #1 PDS suture circumferentially, lateral to the point where the external oblique had been separated, covering this area in an underlay fashion. This allowed for medialization of the rectus muscle. The area was irrigated. The midline was closed with running double-looped PDS over the previously placed biologic mesh. There was a slight increase in peak airway pressure, which decreased after additional release was undertaken. The skin flaps were irrigated and hemostasis obtained. Two 19 F drains were placed in the subcutaneous space. The skin was closed and a sterile dressing applied.

The patient tolerated the procedure well and there were no intraoperative complications. The patient was transferred from the ICU to the surgical floor on postoperative day (POD) 2, but required reintubation on POD 3 after an episode of possible aspiration/

Figure 1. A small recurrence from the previous colostomy was identified and was closed, and all mesh was removed including the eroded portions into the skin.

Figure 2. The patient at her three-week post-discharge visit. pneumonia, and was readmitted to the surgical ICU. She was extubated on POD 13 and was transferred to the floor three days later. She remained in the hospital for completion of a 19-day course of vancomycin. She tolerated advances in her diet and was discharged without drains. At the three-week followup visit (Figure 2), the patient was doing very well and returned home.

Surgeons’ Lounge

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / JANUARY 2015

Question for Be Our Next Expert!

From Amir Mehran, MD University Bariatrics, Thousand Oaks, Calif., and Ara Keshishian, MD, Central Valley Bariatrics, Verdugo Hills, Calif.

A

65-year-old man presented with a painful enlarging symptomatic umbilical hernia of several years duration. He denied obstructive gastrointestinal (GI) symptoms or coughing, urinary hesitancy or constipation. His past history was significant for obesity, hypertension, sleep apnea, gastroesophageal reflux disease, mild lower extremity edema and an open appendectomy. He denied using tobacco. He took olmesartan and approximately a dozen herbal and naturopathic supplements. Physical examination revealed a body mass index of 34 kg/m2 and a partially reducible umbilical hernia measuring roughly 5 cm in diameter. Mild skin “stretch” discoloration was noted as well without obvious cellulitis.

After a thorough discussion of his options, a decision was made to proceed with a laparoscopic repair with mesh due to his obesity and to avoid going through the discolored area. After a thorough medical evaluation, the patient underwent an uneventful laparoscopic umbilical hernia repair with a 15×20 cm Physiomesh (Ethicon Endo-Surgery). The patient had received a 900-mg IV preoperative dose of clindamycin (anaphylactic penicillin allergy), and the mesh had been soaked in antibiotic-laced saline solution.

Three ports were used, including two 5-mm and one 12-mm port, all nonbladed and placed along the left abdomen. The hernia contained omentum, which was dissected off using gentle traction and the Harmonic Scalpel (Ethicon Endo-Surgery). Using the Securestrap fixation device (Ethicon Endo-Surgery), the umbilicus was everted by tacking the hernia sac inside the abdomen, thus giving the patient a normal-looking umbilicus (“innie”). The mesh was inserted through the 12-mm port and did not come into contact with the skin at any point. It was secured with four preplaced Gore CV-0 transabdominal fixation sutures (W.L. Gore), as well as two rows of Securestrap tackers. Diagnostic laparoscopy at the end of the case did not reveal any intraabdominal injuries or bleeding. The Foley catheter that was placed at the beginning of the case was removed without sequelae. The patient tolerated the procedure well and was discharged the same day, at his request, and after he was able to tolerate fluids and void on his own. He was not discharged on any antibiotics.

The patient did well for the next two weeks but then called about a low-grade fever (100.1 F) associated with coughing, hoarseness and left lower abdominal pain near the left iliac crest. He denied any GI symptoms, pain or redness around the incisions. Due to the driving distance involved, he opted to see his primary care physician (PCP) first, who performed routine laboratory tests and diagnosed him with an upper respiratory infection and possible laryngitis.

The patient was seen in the surgical clinic five days

Figure 1. Day of reoperative surgery. later and noted painless erythema around the umbilicus (Figure 1). His abdominal exam was otherwise unremarkable, with no recurrence or seroma formation. On further questioning, however, the patient did complain of a new onset of urinary hesitancy and tenesmus. As he had never undergone a colonoscopy or annual urologic exam, a rectal examination was performed revealing a large hard prostate and extreme discomfort. The erythema boundaries were marked and the patient was discharged on oral clindamycin. The patient’s PCP subsequently changed the antibiotics to nitrofurantoin, as the labs from five days before showed an Escherichia coli urinary tract infection with elevated serum white blood cell (WBC) count. Of note, the patient’s preoperative WBC count was normal and a urinalysis was not performed because he was asymptomatic.

When the patient was contacted a few days later, he reported worsening fever, lethargy and no change in the abdominal wall erythema. He was advised to present to the emergency department, where examination revealed a temperature of 101.9 F, pulse of 123 beats per minute, persistent periumbilical erythema with warmth, but no abdominal distention or any tenderness to palpation.

Figure 2. Intraoperative image of inferior aspect of mesh.

Laboratory work was significant for a WBC count of 24,000 with left shift and a urinalysis revealing positive leukocyte esterase, significant pyuria and moderate bacteria. A contrast abdominal computed tomography was performed, demonstrating a prominent prostate, bladder wall thickening and some nonspecific fluid around the mesh and hernia site.

The patient was admitted to the hospital and upon consultation with infectious disease consultants, was placed on vancomycin, levofloxacin and metronidazole.

Over the next 24 hours, the patient did not clinically improve and the erythema appeared to have worsened.

He was taken to the operating room for laparoscopic exploration and possible mesh removal. Intraoperatively, the superior aspect of the mesh was found to be clean with minor omental adhesions. The inferior aspect, however, had thicker adhesions with a pocket of fibrinous fluid (Figure 2). Using the Harmonic Scalpel, the mesh was fully excised and removed with an endobag. Gram stain of the mesh revealed no organisms with rare polymorphonuclear leukocytes (PMNs).

The patient made a very rapid recovery and was discharged within 48 hours on oral antibiotics pending outpatient evaluation and final mesh culture results, which remained negative. Final pathologic examination of the specimen showed adherent fibro-adipose tissue with fibrosis, fibrin deposition, foreign body reaction and mostly chronic inflammation. In follow-up visits, the patient remains well and does not desire any further herniorrhaphy.

Questions Is this case consistent with mesh allergy or mesh infection and what are alternative management options?

If this was an allergic reaction, is this the typical course and is this particular mesh (or any other mesh) known for this type of reaction? Is there any rationale for prescribing corticosteroids before reoperative surgery?

If this was due to a urinary tract infection, is it likely from a Foley catheter, or prostatitis or both, and is this the normal course (i.e., two weeks postoperatively? No pain and no microbes on path or cultures?)?

Should urinalysis be ordered for all patients, including asymptomatic males, and is there a role for continued antibiotics (IV or oral) after surgery?

Continued ON page 13

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Continued from page 13

Dr. Daes’

Reply

I wish to thank Dr. Szomstein for the opportunity to comment on Dr. Amir Mehran’s questions. I would like to congratulate Dr. Mehran for a comprehensive description of his patient history and successful management of the case.

Allergies and infection of meshes in clear cases are rare events and evidence in the literature is foggy.

There is a variety of guidelines to define a simple redness of skin as was noted in this patient’s initial presentation as a surgical site infection (SSI). Depending on which is used, the rate may vary. The two largest ones in the United States are the Centers for Disease Control and Prevention’s (CDC) National Healthcare Safety Network (NHSN) and the

American College of Surgeons (ACS) National Surgical Quality Improvement Program (NSQIP). The latter is simple and straightforward, whereas the CDC NHSN guideline is a bit more complex.

I will try to answer some of the questions Dr. Mehran posed.

I believe that this patient had a mesh infection. There is nothing in his clinical history or findings to suggest an allergic event: 1. There was no hypersensitivity history such as other allergies or

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autoimmune issues.

2. There was no itching or high eosinophil count on the WBC count.

3. The inflammatory reaction was limited to an area of skin and mesh, and was not as widespread as it would have been in the event of an allergic reaction.

4. Gram stain of mesh with PMN suggests an infection. The time of presentation (mesh infection surveillance is mandatory for one year), the systemic and local signs of infection and the high WBC count all suggested an infection of the mesh.

The most common source of mesh infection is the skin. This patient has some issues related to the skin preoperatively such as “stretch” discoloration, and a tack was used to fix the hernia sac to the abdominal wall to invert the umbilical skin. Conversely, cellulitis was not detected and laparoscopic repair with mesh-placed underlay has a very low incidence of infection. Therefore, I believe that the most probable explanation was that the mesh was contaminated from a distant source: a urinary infection. The fact that a urinary catheter was placed at surgery, the presence of urinary symptoms, albeit late, and the confirmation of E. colii in the patient’s urine make this the most probable cause. The reason that the removed mesh did not show positive cultures may be explained by the fact that the patient was prescribed various antibiotics after surgery. It is difficult to ascertain if infection was already present at the time of surgery. A urine test is part of the preoperative workup and would provide this information. Finally, for clean operations involving meshes, antibiotics should be given prophylactically and not continued after surgery. I hope these comments help answer some of your questions on this difficult topic.

Surgeons’ Lounge

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Additional Replies Sent by email: Anonymous It is very common to have negative culture and negative Gram stain for an infection that has been somewhat suppressed by outpatient antibiotics, in particular if no true abscess has formed.

This case is presumably a surgical infection and should be treated as such. Aside from the antibiotics complicating the diagnosis, certain infections such as Staph epidermitiss and anerobes can be difficult to culture. The Foley placed at the time of surgery is the most likely cause of his urinary infection and had nothing to do with his surgical infection.

Happy Holidays from the General Surgery Newss team, from left: Dan, Diane, Michael, Kate, Kevin and Deanna.

Happy Holidays!

Aiden O’Rourke, MD Taos, N.M. (formerly from Ft. Lauderdale, Fla.)

1. It is not consistent with a mesh allergy, as only the inferior part of the mesh was involved.

2. The patient did develop a urinary tract infection as a result of the surgery. In obese patients, the umbilicus descends on the abdominal wall.

The bladder or urachus are drawn into the hernia. One needs to dissect a bladder flap inferior to the hernia in order to prevent a tack or suture entering the bladder, where it will behave as a foreign body and serve as a nidus of infection; hence a delayed urinary tract infection.

3. I do not perform a preoperative check with a urinalysis for ventral hernias.

4. The fibrinous fluid would indicate that the mesh was infected despite the negative cultures. Of note, the patient was on antibiotics.

Introducing the only antibacterial-coated biologic graft *

XENMATRIX™ AB Surgical Graft

Protection when and where it’s needed. *It’s the first biologic graft for ventral hernia repair demonstrated to prevent colonization of MRSA and E. coli.

Protect the graft. Protect the repair.

Bard, Davol, and XenMatrix are trademarks and/or registered trademarks of C. R. Bard, Inc. All other trademarks are the property of their respective owners. © Copyright 2014, C. R. Bard, Inc. All rights reserved.

DAV/XNAB/0814/0018

Indications: Intended for implantation to reinforce soft tissue where weakness exists and for surgical repair of damaged or ruptured soft tissue, including: abdominal plastic and reconstructive surgery; muscle flap reinforcement; hernia repair including abdominal, inguinal, femoral, diaphragmatic, scrotal, umbilical, and incisional hernias. The Rifampin and Minocycline coating has been shown in preclinical in vitro and in vivo testing to reduce or inhibit microbial colonization in the device. The claim of reduction of bacterial colonization of the device has not been established with human clinical data, nor has a clinical impact associated with this claim been demonstrated.

Contraindications: 1. XENMATRIX™ AB Surgical Graft should not be used on patients with known sensitivity to porcine products.

2. Do not use in patients with allergy, history of allergy or hypersensitivity to tetracyclines or rifamycins or other components in the device.

3. Do not use in pregnant or nursing women.

4. The contraindications, warnings and precautions regarding the use of the antimicrobial agents Rifampin (a derivative of rifamycinB) and Minocycline (a derivative of tetracycline) apply and should be considered when using this device. See FDA’s drug labeling database for Rifampin and Minocycline labeling.

The use of this product in patients with compromised hepatic function should be carefully considered since rifampin can cause additional stress to hepatic metabolism. Implantation of this device would not result in detectable systemic concentrations of Rifampin or Minocycline.

Warnings: 1. This device is not indicated for the treatment of infection. If an infection develops, treat the infection aggressively.

2. To minimize recurrences when repairing hernias, the graft should be large enough to provide sufficient overlap beyond the margins of the defect on all sides.

3. An allergic reaction that is unrelated to other therapy is an indication to consider removal of XENMATRIX™ AB Surgical Graft.

Precautions: 1. Do not alter practice of pre-, peri-, or postoperative administration of local or systemic antibiotics.

Adverse Reactions: Potential complications with the use of any prosthesis may include, but are not limited to, allergic reaction or hypersensitivity to device materials or antimicrobial coating, seroma, infection, inflammation, adhesion, fistula formation, erosion, hematoma, and recurrence of tissue defect.

16

In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / JANUARY 2015

‘Normal’ Stomach on Endoscopy May Be Anything But Precautionary Biopsies Make Sense B Y M ARIE R OSENTHAL PHILADELPHIA A—Nearly 30% of stomachs that appear to be normal during endoscopy in fact may have significant gastric histopathology, according to a new study, which suggests that endoscopists may want to consider taking more biopsies as a precaution.

This approach may seem counterintuitive because many biopsies of areas that appear to be abnormal on endoscopy, with areas of erythema, inflammation or atrophy, often are histologically unremarkable. If an abnormal area is unlikely to reveal histopathologic findings, neither will a normal area, explained Daniel T. Nevin, MD, lead researcher of the poster presented at the 2014 annual meeting of the American College of Gastroenterology.

“If they don’t see endoscopically apparent abnormalities, such as erythema, [endoscopists] call the gastric mucosa normal, and many don’t perform a biopsy,” said Dr. Nevin, a gastrointestinal pathologist at Miraca Life Sciences Research Institute, in Irving, Texas. “However, a significant proportion of these [stomachs] are not normal on histopathologic examination. And that is the main point of our study: You cannot confirm normal gastric mucosa by the endoscopic appearance alone. You really need to do a biopsy to tell if it is truly normal.”

In the study, the researchers obtained histopathologic, demographic, clinical and endoscopic information from the Miraca Life Sciences database for all of the gastric biopsies they processed between January 2008 and December 2013. They looked at 53,789 patients with a “normal” stomach and 317,401 patients with endoscopic findings of gastritis.

Although histopathologic abnormalities were more likely in the gastritis group than in the normal group, 27% (14,940 of 53,789 patients) of endoscopically normal stomachs had gastric pathology, such as infection with Helicobacter pylori, chronic inactive gastritis, reactive gastropathy, intestinal metaplasia or atrophic gastritis. These cases would have been missed if a biopsy was not done because the stomach looked normal through the endoscope, according to Dr. Nevin.

20%

15%

10%

Normal stomach

Photomicrograph of an endoscopically ’normal stomach’ showing chronic active gastritis.

Immunohistochemical stain from the same case showing numerous H. pylorii organisms.

“Based on our study, if endoscopy is performed, it may be worthwhile for the clinician to biopsy the stomach, regardless of what it looks like endoscopically,” Dr. Nevin said. “This was a simple study, but I think it is important. If you are going to put someone through that procedure, you don’t want to miss anything, and to do that you

Gastritis

2.61 (2.53-2.70) P<0.0001

1.54 (1.49-1.59) P<0.0001 2.05 (1.96-2.14) P<0.0001 1.19 (1.14-1.24) P<0.0001

5%

0%

H. pylori

IM

CIG

RG

Conditions detected more frequently (with statistical significance) in the endoscopically ’normal stomach’ group versus the endoscopic ’gastritis’ group.

IM, intestinal metaplasia; CIG, chronic inactive gastritis; RG, reactive gastropathy

cannot rely on the endoscopic appearance alone. While clinical indications and clinical discretion is, of course, critical when making the decision whether to biopsy, our study shows that a normal endoscopic appearance does not always equate to an absence of pathology. We think that clinicians can benefit from this new information.”

Not so fast, said Manoop S. Bhutani, MD, director of endoscopic research and development in the Department of Gastroenterology, Hepatology and Nutrition at the University of Texas MD Anderson Cancer Center, in Houston.

“This is helpful information from a pathologic standpoint, but one still has to use one’s clinical judgment when making a decision to biopsy,” said Dr. Bhutani, who is also professor of Medicine and Cancer Systems Imaging at the University of Texas and adjunct professor of biomedical engineering at Houston’s Rice University. If, as an analogy, the purpose of the colonoscopy is to screen for cancer or polyps and the patient has no diarrhea, Dr. Bhutani said he would be hard pressed to justify the additional costs of biopsies to look for microscopic colitis.

Clinicians should use the same reasoning during an endoscopy, he said. The patient’s signs and symptoms, clinical history, comorbidities and the “need to know” would be important considerations when deciding to biopsy.

Then there is the question of where to biopsy and how many biopsies to take, Dr. Bhutani said. Although the study did not specifically address this issue, it did look at the biopsy sites. The sampling patterns were variable, the researchers noted, with the antrum being the most common site biopsied (67% in the normal group; 79% in the gastritis group), and the corpus was sampled about 41% in both groups. Random gastric biopsies from unspecified sites were more common in the normal stomach group (7.5%) than the gastritis group (3.8%) (95% confidence interval [CI] 1.88-2.03).

Cost, too, is a factor. However, Dr. Nevin said the cost of a biopsy would not add much to the total cost of an endoscopy. “If a person has sufficient symptoms to warrant an endoscopy, then biopsy should be strongly considered, as a gastric biopsy does not add that much to the total cost of the procedure,” Dr. Nevin said. “If you are going to the trouble and expense of scoping someone, you don’t want to miss out on identifying something like Helicobacter gastritis for a nominal additional cost.”

Dr. Bhutani noted that although an individual biopsy might not raise the cost of a single procedure, the effect could be significant on total health care spending for endoscopies—and insurance companies might not pay for the procedure if a stomach looks normal.

“I’m in the trenches taking care of patients, explaining my actions to a patient and an insurance company. I have to clinically justify a biopsy in the patient’s stomach looks normal, ” he said. Although the endoscopic biopsies are generally safe, there can be rare complications, especially if the patient is thrombocytopenic or has significant coagulopathy, he added.

But, Dr. Bhutani said, if he had suspicion that the patient had one of the conditions noted in the study or it was clinically relevant to look for one of the conditions, he would consider biopsy even with a normal-appearing stomach. “If you suspect one of these conditions and the stomach looks normal, then yes, I would do a biopsy because of the findings of this study,” he said. “I have to use my clinical judgment and put these very important pathologic findings into the proper clinical context.”

In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / JANUARY 2015

New Study Reignites Debate Over Stretta Meta-analysis Suggests Lack of Clinical Benefit for Endoscopic Procedure; Some Experts Disagree B Y T ED B OSWORTH PHILADELPHIA—A new meta-analysis has found that Stretta, an endoscopic procedure for treating gastroesophageal reflux disease (GERD) with radiofrequency energy, fails to provide clinical benefit to patients who undergo the procedure—reigniting debate over the value of the controversial technology.

The study found that compared with sham or proton pump inhibitors (PPIs), Stretta (Mederi Therapeutics Inc.) was favored in some studies but not in others, so no significant advantage was found in the pooled data, according to the researchers.

Stretta “cannot be recommended as an alternative to traditional medical or surgical therapies for” reflux, said Seth Lipka, MD, of the Division of Digestive Diseases and Nutrition at the University of South Florida, in Tampa, who presented the data at the 2014 annual meeting of the American College of Gastroenterology (ACG).

Lipka’s meta-analysis were normalization of esophageal acid exposure, as measured by pH over 24 hours, and increase in lower esophageal sphincter (LES) pressure, as assessed with manometry.

“These are not the end points most important to clinical benefit,” said Brian J. Dunkin, MD, head of the Section of Endoscopic Surgery at Houston Methodist Hospital in Texas, and presidentelect of SAGES. Dr. Dunkin noted that normalization

of acid is not required for symptom control and healing of esophagitis and is not reliably achieved even with PPIs. In addition, the majority of reflux patients have a normal LES resting pressure, and candidates for Stretta typically do not have significant defects in the LES, such as a hiatal hernia, that would make increasing LES pressure important.

Dr. Dunkin suggested the key goal in treating GERD is control of symptoms and improved quality of life, which were

the primary end points of the studies in the meta-analysis and those the SAGES guidelines committee evaluated.

Stretta, which delivers radiofrequency energy in the area of the LES to remodel muscles and tighten barrier function of the sphincter, was approved by the FDA in 2000.

The meta-analysis, now available on the Clinical Gastroenterology and Hepatologyy website, considered only randomized see GERD page 18

For the Management of Postsurgical Pain

EXPAREL® (bupivacaine liposome injectable suspension)

Patient-Focused Pain Control With A Single Dose

Conflicting Findings However, that conclusion was the opposite reached by a committee for the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES), which found Stretta “appropriate” for adult reflux patients with symptoms lasting more than six months who decline

Based on an analysis that included 21 ciations, the [SAGES] committee found that a preponderence of the data favored Stretta as an effective procedure for reducing symptoms. fundoplication. The recommendation, made in the current SAGES Clinical Spotlight Review for Endoluminal Therapy for reflux, received a “strong” grade for quality of evidence based on 21 citations, including a meta-analysis of 18 studies with 1,441 patients.

The difference in the conclusions is not just based on differences in the data included but, more importantly, in which measures of benefit were analyzed, according to two members of SAGES who participated in development of the guidelines.

The two primary end points for Dr.

Long-Lasting Pain Control With Less Need for Opioids1,2 • Indicated for administration into the surgical site to produce postsurgical analgesia • Reduce pain and opioid requirements1,2 without the need for catheters or pumps

Pivotal studies have demonstrated the safety and efficacy of EXPAREL in patients undergoing bunionectomy and hemorrhoidectomy procedures.

The clinical benefit of the attendant decrease in opioid consumption was not demonstrated.

Important Safety Information: EXPAREL is contraindicated in obstetrical paracervical block anesthesia. EXPAREL has not been studied for use in patients younger than 18 years of age. Non-bupivacaine-based local anesthetics, including lidocaine, may cause an immediate release of bupivacaine from EXPAREL if administered together locally. The administration of EXPAREL may follow the administration of lidocaine after a delay of 20 minutes or more. Other formulations of bupivacaine should not be administered within 96 hours following administration of EXPAREL. Monitoring of cardiovascular and neurological status, as well as vital signs should be performed during and after injection of EXPAREL as with other local anesthetic products. Because amide-type local anesthetics, such as bupivacaine, are metabolized by the liver, EXPAREL should be used cautiously in patients with hepatic disease. Patients with severe hepatic disease, because of their inability to metabolize local anesthetics normally, are at a greater risk of developing toxic plasma concentrations. In clinical trials, the most common adverse reactions (incidence ≥10%) following EXPAREL administration were nausea, constipation, and vomiting.

References: 1. Gorfine SR et al. Dis Colon Rectum. 2011;54(12):1552-1592. 2. Golf M et al. Adv Ther. r 2011;28(9):776-788.

Please see brief summary of Prescribing Information on reverse side.

For more information, visit www.EXPAREL.com ©2014 Pacira Pharmaceuticals, Inc., Parsippany, NJ 07054

PP-EX-US-0501

11/14

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In the News STRETTA

jcontinued from page 17 trials with a sham control or active comparator that included pH and LES pressure data. Of 24 studies drawn from a literature review, four, with a total of 168 patients, met these criteria. In three of the four, Stretta was compared with a sham procedure. In the fourth, PPIs served as the comparator.

For acid control, Stretta was favored in two of the studies, but the control arm was favored in the other two. For LES pressure, two favored Stretta, but the other did

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / JANUARY 2015

not. Other end points, such as ability to discontinue PPI use and the quality of life of patients off medicine, were also similar in the Stretta and control arms, Dr. Lipka said.

The SAGES evaluation was not limited to controlled studies but permitted a broader survey. Based on an analysis that included 21 citations, the committee found that a preponderance of data favored Stretta as an effective procedure for reducing symptoms. It also was found to be highly statistically significant for improving quality of life (P=0.0001).

P Will Rutan, CEO of Mederi

Therapeutics Inc., called the latest study an “apples and oranges” comparison.

“Curiously, the heterogeneity of the studies that were selected [by the University of South Florida investigators] was nearly 100%, rendering this analysis as lacking in scientific value,” he said in an interview.

Not Necessarily Benign Although no serious adverse events occurred in the clinical trials, Dr. Lipka said Stretta is not necessarily benign. Serious complications, although uncommon, have been reported in postmarketing registries, he said. These include esophageal

EXP-AP-0020-201301

’Curiously, the heterogeneity of the studies that was selected ... was nearly 100%, rendering this analysis as lacking in scientific value.’

—Will Rutan, CEO, Mederi Therapeutices Inc perforations directly related to performing Stretta and at least two deaths from aspiration pneumonia associated with the procedure.

Robert D. Fanelli, MD, chief of minimally invasive surgery and surgical endoscopy for the Guthrie Clinic, in Sayre, Pa., and an author of the SAGES recommendations, maintained that the group’s review was comprehensive.

“A large body of evidence was reviewed systematically by our committee. Overall, this evidence was supportive of a benefit for relevant end points of symptom control and improved quality of life,” Dr. Fanelli said. “We applied the same methodology to Stretta as we did to several other endoluminal procedures for which we did not find adequate supportive evidence.”

Dr. Fanelli noted that SAGES used the GRADE (Grades of Recommendation Assessment, Development and Evaluation) system (BMJJ 2008;336:924-926) to analyze the literature. “We did not set out to perform a meta-analysis; we stringently reviewed the body of literature regarding Stretta and determined, using GRADE standards, that it is a safe and effective procedure. The GRADE system supports a strong recommendation when a large body of literature, one unlikely to be influenced by the addition of more literature, supports an intervention; this is the case with Stretta.”

But Dr. Lipka said the SAGES evaluation of Stretta was not sufficiently rigorous. He particularly objected to the use of the term strongg to characterize the quality of evidence.

“The design of our meta-analysis was to protect the patient from the recent recommendation by SAGES,” Dr. Lipka explained. Although he acknowledged that some evidence suggests Stretta reduces LES relaxations, he argued that there is not yet sufficient data to demonstrate that this effect translates into a meaningful clinical advantage.

Dr. Dunkin said Dr. Lipka’s warning about the serious adverse events associated with Stretta was misleading and not based on current information. He added that SAGES is preparing an article for publication that will include a more detailed response to the new report.

None of those quoted in this article, with the exception of Will Rutan, CEO of Mederi Therapeutics, reported any financial conflicts of interest.

In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / JANUARY 2015

Fecal Microbiota Transplants: An Insider’s Guide B Y M ONICA J. S MITH NEW YORK K—Need a blender? Lawrence J. Brandt, MD, a contemporary pioneer and proponent of fecal microbiota transplant (FMT) has a surplus, brought in by patients about to undergo the somewhat radical but overwhelmingly successful treatment for recurrent Clostridium difficilee infection (CDI).

“They never want the blender back,” said Dr. Brandt, professor of medicine and surgery at Albert Einstein College of Medicine and emeritus chief of the Division of Gastroenterology, at Montefiore Medical Center, in New York City.

Interest in FMT has ramped up considerably in the past few years, but the concept dates to fourth-century China, when doctors administered a fecal suspension by mouth for food poisoning or severe diarrhea. “By the 16th century, there was a menu of ways to take stool, and it was given for a variety of disorders: diarrhea, pain, vomiting, constipation,” Dr. Brandt said.

Contemporary use of FMT dates to 1958, when it was administered by enema to treat four patients with

pseudomembranous colitis. It was first used to treat CDI in 1983, and in 2013 the American College of Gastroenterology included consideration of FMT in its guidelines as a treatment for recurrent CDI. “The rationale is that we can avoid another course of the anti-C. difficile antibiotics that, for example, in the case of vancomycin, is really maintaining the condition for which you were given it in the first place: a disturbance in the microbiota, or dysbiosis,” Dr. Brandt said, “FMT can immediately re-establish the normal diversity of the intestinal microbiome and thus restore the ability of the microbiota to resist colonization.”

How It’s Done The first step is choosing a donor, who can be any healthy person. “Whether you’re dealing with a spouse or family member, household contact or total stranger, the results are basically the same, raising the whole concept of a universal donor,” Dr. Brandt said. “People don’t seem to have much difficulty accepting stool from someone they know or don’t know if they’re sick enough, and these people are sick enough.”

’They never want the blender back.’

—Lawrence J. Brandt, MD

The next step is thorough screening.

Donor stool is tested for parasites, C. difficile, giardia, cryptosporidium, isospora and norovirus; the donor also is tested for syphilis; hepatitis A, B and C; HIV infection; and other blood-borne infections.

Some donor exclusions include recent use of antibiotics, diarrhea, constipaation, inflammatory bow wel disease, colorectal can ncer, immunocompromisee, use of anti-cancer drugs,, high-risk sexual behaviors and recent body piercing or tattoos. Otherr exclusions include diabe-tes, obesity, atherosclerotic

cardiovascular disease and mood and neurologic disorders.

Preparation for the recipient includes discontinuing anti-C. difficile antibiotics two to three days before the procedure, and und dergoing a large-volume colonoscopy bowel prep paration the evening beefore.

“I give them some loperamide right before I put the stool in so that they hold it for at least four, preferably six hours,” Dr. Brandt said. “I sometimes give the don nor a gentle laxative the night b before. I like to use stool that’s frresh, passed within six hours—iit does not need to be refrigeraated.”

Dr. Brandt suspends the stool in non-bacteriostatic saline and filters it through gauzee into a canister; it can be mixed d by hand or by blender. W er With a catheter-tipped see FMT page 20

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In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / JANUARY 2015

FMT

procedure and, in my opinion, works as well as colonoscopy,” she said.

syringe connected to the accessory channel of the colonoscope, he administers 300 mL into the ascending colon, or terminal ileum if easily intubated.

Colleen Kelly, MD, clinical assistant professor of medicine at Brown University, in Providence, R.I., also administers FMT during colonoscopy in patients who are healthy enough to undergo the procedure and who have not had a recent colonoscopy. Otherwise, she uses flexible sigmoidoscopy to place the stool. “It’s a less-invasive

Increasing Popularity

jContinued from page 19

Dr. Kelly has seen a definite change in the degree to which FMT is now being offered for CDI, particularly since the publication of a landmark paper that demonstrated a response rate of 82% in patients with CDI who received a nasoduodenal infusion of stool, compared with 31% in those who received vancomycin alone (NEJM M 2013;368:407-415).

“That changed a lot of people’s minds,” Dr. Kelly said. “That, and the FDA’s

decision to enact a policy of enforcement discretion last summer.”

The FDA had formerly required investigational new drug permission for anyone using stool as a treatment. “That really put the kibosh on the use of FMT,” Dr. Brandt said. “So we had a public workshop, made impassioned speeches, a couple of our patients made impassioned speeches, and then in July [2013], the FDA said that for CDI that does not respond to standard therapy, they will exercise enforcement discretion. They are not going to come after you as long as you give the patient adequate informed

consent, tell them that this is an experimental investigative therapy and explain the potential risks.”

Dr. Brandt added that he was thrilled and impressed with the FDA because the agency changed the direction of its policy in response public sentiment, which was bolstered by the positive experiences with FMT to date.

In addition to The New England Journal of Medicinee article and the FDA’s enforcement discretion policy, a couple of other developments evolved last year to help expand the use and investigation of FMT. One is the Fecal Transplant Foundation, a website started by a patient. The site contains a list of FMT providers in both the United States and abroad.

OpenBiome Another is the nonprofit OpenBiome, a stool bank developed by a group of researchers from MIT. “OpenBiome recruits donors, screens the stool and centralizes the whole process,” Dr. Kelly said. They began in 2013 and have now sent more than 1,000 doses to more than 100 sites, including some to providers who don’t perform FMT often enough to establish a donor-screening protocol, she said.

OpenBiome charges a user fee of $250 per dose, significantly less than the cost of donor screening, which can run to $1,000 or more. “They’ve been really successful in helping providers and researchers. I think their hope is to help people who want to do FMT research obtain materials for their study,” Dr. Kelly said.

Researchers are already looking into FMT as a treatment for various gastrointestinal disorders; several papers were presented at Digestive Disease Week 2014.

Dr. Brandt said researchers are interested in the technique’s potential to treat conductions unrelated to the gastric tract.

“Insulin resistance, obesity, Parkinson’s, multiple sclerosis, autism: There are bits of scattered data out there that suggest there may be something to this,” he said.

Fecal transplant, however, is only the first step in the probiotic journey. “People have used frozen fresh material, an extract of stool that it is added to water and diluted; it has exactly the same effect as [fresh] feces,” Dr. Brandt said. A small study showed that a mixture of 33 strains of bacteria derived from normal stool and synthesized into a “living liquor” was able to cure patients of recurrent CDI. “And then there are the poop pills in Canada, 27 to 34 pills [each] that that cured them of their disease,” he said.

“So we’re now looking at stool and at different types of derived preparations.

We start with a lot [of bacterial strains], we then go to a few, we may soon even go to a single strain, and perhaps one day we won’t even give the bacteria, maybe just the metabolic products of those bacteria.”

In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / JANUARY 2015

In Quest of an EMR System for Surgeons A Surgeon and a Reporter Search for the Ultimate—or At Least Passable—System B Y V ICTORIA S TERN Kaufman, MD, FACS, has been searching JforarrodanP.electronic medical record (EMR) system for his small surgical practice. With more than 100 systems on the market, Dr. Kaufman theoretically should have his pick.

However, over the past 10 years, Dr. Kaufman has personally used four different EMRs and demo’ed more than 15, yet hasn’t found one that entirely suits his needs as a general surgeon. In fact, he recently went through a failed EMR implementation, which he called “a small catastrophe.”

“Most companies claim to have an amazing system and boast that you can tailor it to your individual requirements,” Dr. Kaufman said. “Essentially, this means a blank slate that you can spend months programming to say what you’d like it to say. But I have not yet found an EMR that is pre-programmed to deal with general surgeon–specific demands, one that can meet even the most basic needs of a general surgeon, such as a simple, hassle-free way to schedule surgical cases.”

Wanting to take a fresh look in 2014, Dr. Kaufman enlisted the help of a science writer (myself ) to see if any general surgeon–specific EMRs actually exist and, if so, how well they work.

Our main goal: Find an EMR system for Dr. Kaufman’s practice that is designed for general surgeons.

Our process: Look for a system that is made specifically for or that markets itself to general surgeons.

Contact companies with highly rated systems. Test the technology.

Before we began our investigation, Dr. Kaufman described his predicament to me. The main issues, he said, boil down to technology, speed and cost. Certain EMRs target subspecialties—basic protocols set up for pediatricians, family practice physicians or gynecologists—but none appear pre-programmed to handle the most common demands of a general surgeon, the bread-and-butter procedures and daily business of any surgical practice.

“If you’re lucky, an EMR might have what you need to complete an interaction with a patient for one of the top 10 general surgical problems,” Dr. Kaufman said.

“So, if a person has biliary colic, for example, the EMRs I’ve seen aren’t set up so I can easily transition to booking the case in the hospital. It’s this kind of really basic stuff that is lacking.”

Instead, Dr. Kaufman would need to customize the EMR software himself to capture all essential aspects of surgical care and patient management, a process that takes no small amount of patience and time out of an already overextended schedule. In some cases, the time required to tailor an EMR is so significant that practices will hire full-time staff to accomplish this task, constituting another expense in an already costly venture.

In fact, according to a 2013 RAND survey, the current state of EMR technology is one of the top reasons physicians report being dissatisfied with their jobs. In the report, physicians’ main concerns about EMRs included the learning curve required to master the new technology, time-consuming data entry, and reduced physician–patient interaction. Reflecting on

According to a 2014 survey conducted

by Medscape, 23% of responding physicians reported paying $50,000 or more per physician to purchase and install their EMR, while only 8% paid less than $10,000. the inefficiency of EMRs, one general surgeon in the report recalled: The first place we started seeing [an electronic health record], if you will, was in operating rooms [during] the perioperative time … where the nurse would be recording.

She used to fill out a form by hand. Now it’s in the computer, and everybody was like … “it’s taking three times as long to populate all the fields that you have to populate.” … The joke early on, like on an appendix or a gallbladder or something that went really fast and easy, is: “We’re done, and the nurse is over there still trying to get in the pre-op data.” She has now spent 90% of her time at a screen, having to enter data that takes her away from circulating.

Speed also is a major concern. During company demonstrations of a product, a surgeon is presented with an idealized scenario, watching a representative zip through various training modules. If the EMR is Web-based, the demo may be on a particularly fast line, or perhaps the demo is not even live. Both scenarios can give potential buyers a false sense of how fast the system really performs.

Once you purchase the EMR, however, speed may become a different story. Aside from your Internet speed and the memory available on your server—factors you can more or less control—issues with an EMR’s speed usually come down to how well the software is designed or installed, or how overwhelmed the EMR’s data center connection is, as there may be thousands of other users trying to access data.

“With one of our EMRs, I’d sit there staring at a spinning wheel for three minutes, just trying to log in,” Dr. Kaufman recalled.

Yet another issue is cost. EMRs can be a heavy financial burden on a practice. According to a 2014 survey conducted by Medscape, 23% of responding physicians

reported paying $50,000 or more per physician to purchase and install their EMR, while only 8% paid less than $10,000. For some systems, the majority of the costs are up front; for others, the costs creep up throughout the year in hefty maintenance fees or software upgrades.

“You walk in thinking I’m spending $20,000 for a system, now I’m done; but then the company tacks on $5,000 per year per user for maintenance and updating fees,” Dr. Kaufman said. “There are often things that you learn only after you’ve signed up and are six months into implementation.”

Even EMR systems that market themselves as “free” often come with a catch. For instance, a free EMR may charge you a substantial fee to transfer patient data out of the system. One of the best-known free EMR systems appears to make money by selling advertisements and anonymous patient data. Another free system that we investigated puts the onus on patients, charging them a yearly fee to access a patient portal to book appointments, view test results and contact their physicians.

If the EMR does not include a practice management suite, physicians will need to purchase one in addition to a patch to connect the new EMR with the practice management system.

“So, imagine you’ve just bought a $50,000 EMR and a $30,000 practice management system, and now you have to pay someone $10,000 for the two systems to talk to each other,” Dr. Kaufman said. “[That’s yet] another expense to contend with.”

The Demo Process Dr. Kaufman and I began to sift through a long list of EMR companies. Unfortunately, we didn’t find a single EMR made for general surgeons, only systems that claimed to cater to general surgery in addition to many other specialties. We had barely begun the process, yet already had answered our first question: There is no general surgeon–specific EMR. We decided to pick a handful of EMRs that physicians generally rated among the best systems, according to the 2014 Medscape survey, and that also catered to small practices. At this point, our hope was that one or more would have robust modules already in place for see EMR QUEST page 22

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In the News EMR QUEST

jcontinued from page 21 general surgeons.

I contacted about a dozen companies to schedule demos, informing them that I would be shadowing a general surgeon as he looked for a new EMR system for his practice. Several companies declined to participate. One explained that “some proprietary information is given during this cycle that we do not wish to be made public.” Another system was not compatible with Mac OS, which meant Dr. Kaufman and I could not test it at all. Other companies agreed to our conditions, and we began scheduling demos.

Below, I’ve highlighted our experience with three actual EMR companies. [The names of the companies, products and representatives have been changed.]

1. Company X: We arranged a conference call with this company’s representative, Ms. Smith, who launched into her monologue, explaining that Product X is a cloudbased system with more than 1,500 users. When Dr. Kaufman asked how many surgical practices use Product X, Ms. Smith did not know.

After her introduction, Ms. Smith walked us through Product X’s general displays: main category tabs for dashboard, patients, schedule, messaging, reports and preferences at the top of the screen. Under each heading, she described how a physician could fill in basic information. In the “patients” section, for instance, there is a tab for demographic information, patient preferences and insurance information—all pretty standard stuff.

When Dr. Kaufman asked if he could schedule surgery for a patient at a different institution, Ms. Smith noted that the demo site is set up as a single location for a single provider, but that he could introduce a new location. Although the displays in the demo are general, Ms. Smith assured us that “[Product X] is customizable by specialty and by user. Any of the tabs can be reordered, renamed or removed if not applicable.”

Toward the end of the tour, Dr. Kaufman asked whether Product X included a practice management system. Ms. Smith said Product X is not an all-inclusive suite but the company partners with practice management vendors, and it may cost Dr. Kaufman an additional $3,000 to $4,000 to make a practice management system compatible with Product X. After the demo, Dr. Kaufman pointed out to me that Ms. Smith had not prepared a general surgery–specific platform. She showed us only the very generic, barebones demo platform, which ran without a hitch but had nothing surgeons use or need. Although she claimed that “[Product X] is customizable by specialty,” this was not necessarily a plus for Dr. Kaufman. He would need to customize everything for his personal use.

“Basically she was showing us fluff, not any actual content,” Dr. Kaufman said. “From my experience, the rep ends up showing you what they want to show you, not how the EMR would apply to you.”

Additionally, linking the EMR with a practice management system would be time-consuming and expensive, likely significantly more than the $4,000 that Ms. Smith estimated. Dr. Kaufman described a typical scenario: When you try to export data from an EMR to a practice management system, it may mix up the data, for example, sending a patient’s Social Security number to the phone number box. Then, you have to pay a software company for a patch so the two systems can

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / JANUARY 2015

communicate. It may not be a one-time fee, either; you may face ongoing charges to fix a range of issues.

“Overall, Ms. Smith provided a perfect example of the issues I was talking about,” Dr. Kaufman said.

2. Company Y: When this company’s demo began, our tour guide, Mr. Jones, informed us that Product Y is designed for physicians in family practice. When Dr. Kaufman asked whether the company had developed any general surgeon–specific content, his answer was a simple no. Similar to Product X, Dr. Kaufman would need to create those templates from scratch.

Probing a bit more, Dr. Kaufman asked whether the EMR contains a module that would allow him to book a surgical case in the hospital. Could he upload a specific form to the EMR, one that the hospital requires to book a case, and amend that form and send it to the hospital?

“We can’t function without booking surgical cases, and hospitals are very strict about the forms we use to

Mr. Williams explained that the EMR, Product Z, is a cloud-based system that includes a suite of fully integrated products: an EMR, a practice management and billing system, and a patient portal and messaging center.

One major advantage of Product Z is that it had actual content relevant to general surgeons. We were guided through a patient visit, in which Mr. Johnson, a clinical sales specialist, showed us how a surgeon could schedule and create a care plan for a patient with an inguinal hernia. Mr. Johnson noted that his company could customize more general surgery–specific platforms for Dr. Kaufman.

Company Z appears to be particularly strong in customer service. For instance, as Mr. Williams explained, if payors are having problems switching from ICD-9 to ICD-10 and deny a claim, Company Z will lend physicians that money interest-free until the claim is approved.

Additionally, the company says it will largely customize

’The problem is that you essentially have to create your own software, which could take months, and it will cost you a bundle to do so once you tack on the EMR, practice management and especially, the billing fees.‘ —Jarrod P. Kauffman, MD

book a case,” Dr. Kaufman explained to Mr. Jones.

After checking with a colleague, Mr. Jones confirmed his belief that Product Y does not have the capability to upload a specific form.

We quickly switched gears to discuss pricing. The initial cost is $2,395 per provider, which includes $1,195 for maintenance—a package that contains product support, enhancements, upgrades, e-prescribing and more.

If you want to continue the maintenance after the first year, it will cost $1,195 per provider per year. The charges increase when you add the practice management system, a new component of Product Y, which comes to $249 per provider per month, and the billing system, which takes out 7% of a practice’s billable charges each month.

There are other fees as well. If you want your system hosted by the cloud, that costs $39 per connection per month, and if you want to interface with labs, that’s $750 per lab per practice. Each price alone doesn’t sound too bad, but when you add it up for each user each month, the cost balloons. For a practice composed of two surgeons and 10 other staff, Dr. Kaufman would be shelling out well over $20,000 annually plus the 7% of billable charges.

“The problem,” Dr. Kaufman said, “is that you essentially have to create your own software, which could take months, and it will cost you a bundle to do so once you tack on the EMR, practice management and especially, the billing fees.”

3. Company Z: This company had the most comprehensive presentation we had seen so far. Sales executive

the EMR for the physician. If Dr. Kaufman wants a module that pertains to surgical oncology, Mr. Johnson said Company Z will construct it for him. If Dr. Kaufman needs to send a specific form to the hospital to book a case, Mr. Johnson said the company will build it for him at no cost.

The hitch came when we discussed cost. True, Company Z does not charge for each component of its services, but it does charge about 7% of a practice’s annual revenue. Although Dr. Kaufman noted that this was a common fee for billing services, it is still a great expense. “If my practice earned $1 million, we’d be paying $70,000 for the year,” Dr. Kaufman said. “What if we earned $2 million? That would be $140,000. Yes, Company Z does offer a lot of services, but you’re paying through the nose for them.”

Dr. Kaufman is still looking for an EMR system that’s right for him. At the moment, his practice has no EMR. “It is so time-consuming to look at these systems,” Dr. Kaufman said. “Eventually, after seeing two or three, you get exhausted and end up just trying to choose the ‘best’ one out of the batch, even though you haven’t actually seen the system—you’re only on a demo.”

From Dr. Kaufman’s personal experience and our demo experiment, it appears that all EMRs and practice management programs basically have similar degrees of dysfunctionality for a general surgeon, or they come with a big price tag.

Despite this, Dr. Kaufman’s hope is that “because we are raising the issue and bringing attention to an unmet need, some EMR companies will develop well-thoughtout, robust programs specifically for general surgeons.”

Jokingly, Dr. Kaufman said, “You and I should just create our own EMR for general surgeons. We’d make millions.” He paused for a moment and then admitted, “I’m actually half-serious.”

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GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / JANUARY 2015

Alexis Carrel: Nobel Winner, Brilliant Career Tarnished by Nazi Party Link B Y V ICTORIA S TERN one year after Allvar Gullstrand, Just MD, PhD, received the Nobel Prize in Physiology or Medicine in 1911, another surgeon, Alexis Carrel, won prize “in recognition of his work on vascular sutures and the transplantation of blood vessels and organs.” Although French by birth, Dr. Carrel did much of his pivotal work while living in America, and is considered

the first medical scientist working in America to win a Nobel Prize.

“Dr. Carrel has been called a visionary,” said L. G. Walker Jr., MD, former chairman in the Department of General Surgery, Carolinas Medical Center, in Charlotte, N.C., who has studied the life and work of Dr. Carrel. “He was hardworking, precise, inquisitive and honest.”

But Dr. Carrel remains a controversial, and often misunderstood, figure. Despite his many notable accomplishments, his

quirky, oftentimes provocative, ideas landed him in hot water several times in his career, Dr. Walker noted.

Dr. Carrel’s early triumphs, including a novel suturing procedure that changed the surgical landscape and a method for cleaning wounds that saved countless lives in World War I, may be overshadowed, in part, by his later endeavors. In the 1930s, intrigued by the idea of creating a class of genetically elite people, he became focused on the study of eugenics.

Alexis Carrel, MD, received the Nobel Prize in 1912 for his work in transplantation and suturing.

Given free rein to pursue his ideas during World War II, under the auspices of the Nazi regime, Dr. Carrel became inextricably linked to the political party, which damaged his reputation.

“The end of his life was a tragedy,” Dr. Walker said. “His death marked an unhappy ending, which undermined his standing as a brilliant investigator and his friendships with colleagues.”

Rise to Fame Born on June 28, 1873, Dr. Carrel spent his childhood in Lyon, France. Dr. Carrel’s father, a successful textile merchant, died of pneumonia when Dr. Carrel was 5 years old. As the eldest of three children, Dr. Carrel became “the man of the house” and forged a close bond with his mother.

After the father’s death, the family’s finances took a downturn, but Mme. Carrel made sure her children received a Catholic education. Initially, she homeschooled Dr. Carrel, but later sent him to St. Joseph’s, a Jesuit school in Lyon.

Although never known as an outstanding student, Carrel received a Bachelor of Letters in 1889 and a Bachelor of Science in 1890 from the University of Lyon.

When choosing a path after university, Dr. Carrel opted for a career in medicine rather than in the army. In 1893, he graduated from medical school at the University of Lyon, and held an externship for two years at the Red Cross Hospital Antiquaille.

Before Dr. Carrel entered the military in 1895, his life took an unanticipated turn. In 1894, a knife-wielding assassin stabbed French President Sadi Carnot in the abdomen, lacerating the portal vein. Surgeons could not save him and the president bled to death.

Dr. Carrel, however, thought that President Carnot could have been saved

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with the appropriate suturing technique.

This notion inspired him to develop a method to repair blood vessels by using fine sutures and meticulous technique.

Mathieu Jaboulay, MD, a French surgeon at the University of Lyon, had already sutured blood vessels successfully, and was the first to publish his results, but his technique was not effective for small blood vessels.

During Dr. Carrel’s years at the HôtelDieu hospital in Lyon from 1896 to 1900, he began developing new techniques for suturing blood vessels, looking for finer needles and thread and employing an over-and-over continuous stitching, putting the stitches only partially through the vessel wall, instead of Dr. Jaboulay’s single interrupted method, which penetrated the vessel.

In 1901, Dr. Carrel completed his doctorate in medicine. Despite his notable work on suturing, he struggled to find a surgical staff position at the university hospital, and became an instructor of anatomy and surgery. In his spare time, he continued to experiment with suturing.

His persistence and exceptional surgical skill became evident in his experiments on dogs, in which he first successfully sutured the femoral artery and saphenous vein, and later sewed carotid arteries to jugular veins. He also published his first articles on vascular anastomosis, in which he foreshadowed his interest in organ transplantation (Lyon Medd 1902;99:114; Lyon Medd 1902;99:152).

A Man of Science and Miracles Although a man of science, Dr. Carrel was also deeply religious and fascinated by “miracles, magic and telepathy,” Dr. Walker wrote in a 1989 article (Surg Gyn & Obstett 1989;168:363-370).

In May 1902, Dr. Carrel decided to venture to Lourdes, France, known for its miraculous cures, to study such wonders firsthand. On a train filled with sick passengers, Dr. Carrel met Marie Bailly, a dying woman presumed to have peritoneal tuberculosis.

Several conflicting accounts of what transpired on this journey exist, but according to Ms. Bailly’s own descriptions, she begged her friends to smuggle her onto the train bound for Lourdes.

Along the journey, Dr. Carrel found her in critical condition. He gave her morphine and stayed with her until the train reached its destination.

On arriving at Lourdes, Ms. Bailly went to the famous baths, where she was doused with a bucketful of holy water three times. In his short novel, The Voyage to Lourdes, published after his death by his wife who found it among his papers, Dr. Carrel recounted watching the blanket covering the woman’s distended abdomen flatten as the swelling subsided. Uncomfortable with what he had witnessed,

‘Between 1901 and 1910, Alexis Carrel, using experimental animals, performed every feat and developed every technique known to vascular surgery today.

—Julius Comroe Jr., MD Dr. Carrel, who refers to himself as Lerrac (his name backward), wrote: “There

was no denying that it was distressingly unpleasant to be personally involved in a miracle. But [Lerrac] had to come to Lourdes, he had seen something happen, and he had no more right to distort the results of his observation here than in a laboratory experiment at home.”

Soon, Ms. Bailly made a full recovery. Dr. Carrel and several physicians in Lourdes examined her, but could not find an explanation for her recovery. (Ms. Bailly remained in good health, until her death at age 58.) Dr. Carrel’s inquiry caused a backlash from members of the church, who felt that by studying what had

happened he was not accepting an “act of God.” His trip to Lourdes also upset his scientific colleagues, who thought that entertaining the possibility of a miracle damaged Dr. Carrel’s reputation.

“He danced around the miracle issue,” Dr. Walker said. “At that time, there was a strong feeling of anticlericalism in the scientific community in France. So he got in trouble with the Church because he didn’t forthrightly talk about this as a miracle, and [also] with [the] scientific community for even implying this could have been a miracle.” see ALEXIS CARREL page 26

25

26

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GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / JANUARY 2015

ALEXIS CARREL jcontinued from page 25

Carrel in North America Dr. Carrel was subsequently denied a full faculty position at the University of Lyon, prompting his journey overseas to North America to find work, in 1904.

Dr. Carrelâ&#x20AC;&#x2122;s first stop was a conference in Montreal, where he presented an article on blood vessel anastomosis and transplantation. At this point, he had altered his suturing approach in favor of Dr. Jaboulayâ&#x20AC;&#x2122;s through-and-through stitching, and had settled on using the finest lace needles

and thread, which allowed him to work on delicate vessels. He also devised a triangulation technique, which involved holding the vessel open and keeping the back wall clear of the stitching in front, a method that is still used today to deal with difficult end-to-end anastomosis.

Impressed with his work, George Stewart, MD, invited Dr. Carrel to work alongside Charles Guthrie at the University of Chicago. There, Dr. Carrel became immersed in organ transplantation, publishing some of his first work with Dr. Guthrie in 1905, called â&#x20AC;&#x153;Functions of a Transplanted Kidney.â&#x20AC;? In it, they described

successfully transplanting a kidney from a dogâ&#x20AC;&#x2122;s abdomen to its neck. Although the dog died a few days later, the transplanted kidney produced urine. He and Dr. Guthrie also transplanted kidneys and ovaries, and even a heart, from one dog to another. These experiments paved the way for clinical organ transplantation in the 1950s.

In 1906, Dr. Carrel accepted an invitation to join The Rockefeller Institute for Medical Research (today, The Rockefeller University) in New York City, the first institution in the United States devoted solely to medical research. The culmination of his work at Rockefeller ultimately

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Current Symptoms Â&#x2021; Dyspnea Â&#x2021; Coughing with hemoptysis Â&#x2021; Chest pain Vital Signs Â&#x2021; Height: 177.8 cm (70â&#x20AC;?) Â&#x2021; Weight: 65 kg (143 lb) 6LJQLÂżFDQW 0HGLFDO +LVWRU\ Â&#x2021; Hypertension Â&#x2021; Chronic obstructive pulmonary disease (moderate) &XUUHQW 0HGLFDWLRQV Â&#x2021; Metoprolol succinate ER 50 mg/d Â&#x2021; Tiotropium bromide inhalation powder Laboratory Results Â&#x2021; 2-cm lesion in right upper lobe revealed on chest computed tomography (CT) scan; PDOLJQDQF\ FRQÂżUPHG ZLWK QHHGOH ELRSV\ Â&#x2021; No abnormal bronchopulmonary or mediastinal lymph nodes; brain CT, isotopic bone scan, abdominal ultrasonography negative for distant metastases Â&#x2021; )RUFHG H[SLUDWRU\ YROXPH LQ WKH ÂżUVW second: 43.6% of predicted value (1.44 L) Â&#x2021; Carbon monoxide diffusing capacity: 71.7% of predicted values (20.19 mL/min/mmHg) Â&#x2021; Cardiac ultrasonography: normal pulmonary artery pressure (22 mm Hg) At induction, Harold receives propofol 1.5 mg/kg and rocuronium 0.6 mg/kg. During the procedure, movement of the diaphragm interferes with surgery.

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

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Each activity will present a clinical scenario that you face in your daily practice. After reading the introduction to the case, consider the challenge questions, and then visit ZZZ &0(=RQH FRP QPE WR ÂżQG RXW KRZ \RXU DQVZHUV stack up against those of our multidisciplinary faculty panel.

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earned him the Nobel Prize in 1912.

At Rockefeller, Dr. Carrel continued his transplantation and suturing work, performing saphenous vein bypasses, coronary artery grafting and vascular prosthesis as well as blood transfusions and limb replantation, in which he transplanted the thigh from one dog to another.

In 1908, Dr. Carrel also began to work on wound healing, an endeavor that proved instrumental during World War I. He experimented on guinea pigs, creating wounds on the skin, dressing them and measuring the healing process, and by 1913, he tried treating leg ulcers.

Dr. Carrel was rewarded for his groundbreaking work, receiving the Nobel Prize in Physiology or Medicine in 1912. Commenting on Dr. Carrelâ&#x20AC;&#x2122;s legacy, surgeon Julius Comroe Jr., MD, wrote: â&#x20AC;&#x153;Between 1901 and 1910, Alexis Carrel, using experimental animals, performed every feat and developed every technique known to vascular surgery todayâ&#x20AC;? (Cardiovasc Dis 1979;6:251-270).

Antisepsis and World War I When World War I broke out in 1914, Dr. Carrel served as a major in the French Army Medical Corps, stationed in Lyon. â&#x20AC;&#x153;During this time, he got the idea that contaminated wounds should be treated with antiseptics,â&#x20AC;? Dr. Walker said.

Dr. Carrel reached out to chemist Henry Drysdale Dakin, who also worked in New York City. The duo met in Paris, and with funding from the Rockefeller Institute to establish a research hospital, they devised a new way to treat war wounds called the Carrelâ&#x20AC;&#x201C;Dakin method.

The duo tested more than 200 solutions before settling on sodium hypochloriteâ&#x20AC;&#x201D; what we know today as Cloroxâ&#x20AC;&#x201D;as an antiseptic that would not harm tissue.

Dr. Carrel also developed a delivery system, configured with tubes to irrigate the wounds on a precise two-hour schedule. â&#x20AC;&#x153;This method of wound healing marked quite an advance,â&#x20AC;? Dr. Walker said. â&#x20AC;&#x153;Dr. Carrel showed that by using a solution of sodium hypochlorite, buffered to make it almost neutral, he could decrease the bacterial contamination of wounds.â&#x20AC;?

Such treatment was very important given that antibiotics had not been discovered and that the battles of World War I were fought in cow pastures in France, where massive wound contamination from organisms occurred, Dr. Walker noted.

Drs. Carrel and Dakinâ&#x20AC;&#x2122;s treatment sparked a huge debate among British physiologists and bacteriologists who felt that antiseptics did not work in wounds.

However, the success of the Carrelâ&#x20AC;&#x201C;Dakin method spoke for itself. Deaths and amputations decreased significantly following its implementation. â&#x20AC;&#x153;The Carrelâ&#x20AC;&#x201C;Dakin solution was used after the war to treat industrial wounds and trauma in general, but with the

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GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / JANUARY 2015

development of antibiotics, it has become less important over time,” Dr. Walker said.

Perhaps more notable than the method was Dr. Carrel’s overall efforts to improve wartime care, which included blood transfusions, hemorrhagic shock treatments and other elements of day-to-day patient care. Dr. Carrel received the Legion of Honor from France for this work.

Before the war, he met his future wife, Anne de La Motte, who was working as a nurse in Paris. “Anne worked with Dr. Carrel closely in his WWI hospitals, and she was described as a tyrant and boss of the hospital,” Dr. Walker said, citing an account by Harvey Cushing, MD. In 1930, Dr. Carrel forged an important collaboration and friendship with the American aviator Charles Lindbergh, which led to the development of a perfusion system in 1935 that permitted living organs to exist outside the body for a period of time. Col. Lindbergh had approached Dr. Carrel about helping his sister-in-law, who had developed heart failure from mitral stenosis. Lindbergh proposed devising a technique to operate on the bloodless heart, but Dr. Carrel dismissed this idea in favor of developing the first perfusion pump, which could maintain the heart and other organs outside the body by circulating fluids through them.

According to Richard J. Bing, MD, director of experimental cardiology, Huntington Medical Research Institutes, in Pasadena, Calif., if Dr. Carrel had followed Lindbergh’s suggestion, he could have advanced the future of cardiac surgery by many years. Still, the perfusion pump marked a step forward. Lindbergh and Dr. Carrel published “The Culture of Organs” in 1938, describing their work. k “While it was not a major medical advance in itself, the glass perfusion pump encouraged people to think about bypassing the heart, which was later done by John Gibbon, MD, in 1953, with the first heart–lung machine,” Dr. Walker said.

with the scientific precision he gave to his suturing technique. During World War II, with France under the Nazi regime, Dr. Carrel became the director of the Carrel Foundation for the Study of Human Problems, an institution established by the Vichy government.

Dr. Carrel’s persistence and ego may have blinded him to the reality of what was happening. “It likely didn’t occur to him that the Vichy government was anything but a patriotic group trying to save France, when in fact the reality was far different,” Dr. Walker noted.

Dr. Carrel’s relationship with the

Nazi-supported Vichy regime sullied his reputation. He was considered by many to be a Nazi collaborator, and when France was liberated in 1944, he was placed under house arrest and charged with cooperating with the Nazis.

Perhaps spurred by the stress of these accusations and his fall from public grace, Dr. Carrel suffered a heart attack and then a stroke, which led to his death in November 1944, before going on trial.

According to Dr. Bing, who worked with Dr. Carrel in the 1930s, “most of the descriptions of Carrel that you read about are wrong. Some people make him out to

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have been a diabolical scientist with a Nazi connection,” Dr. Bing wrote in an article ( (JAMA A 1983;250:3297-3298). “But to me, a young kid, he was wonderful. … Carrel showed me only interest and affection.”

Commenting on Dr. Carrel’s career as a whole, Dr. Walker noted that most people never experience such extreme ups and downs in their careers. “During the first [world] war, Dr. Carrel was called a hero, and by the second, he was considered a traitor,” Dr. Walker said. “His early work was brilliant, unbelievably advanced for the time, but in his own hubris, he may have sealed his fate.”

A large body of evidence demonstrates that hemodynamic optimization through Perioperative Goal-Directed Therapy (PGDT), utilizing dynamic parameters which are informative in determining fluid responsiveness, has been shown to reduce post-surgical complications.1-4

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meta-analyses confirmed reduction of risk for AKI, anastomotic leaks, pneumonia, SSI and UTI.1-4 When evidence inspires action, Edwards Enhanced Surgical Recovery program is here to help you implement PGDT. Your vision for reducing post-surgical complications can be realized in a single procedure, or as part of a larger initiative like the Perioperative Surgical Home or a Quality Improvement Program.

A Controversial Figure Along with his important work in suturing and wound healing, Dr. Carrel is also associated with more contentious ideas about eugenics.

In 1935, Dr. Carrel published his infamous book, “Man, the Unknown,” in which he explored creating a genetically superior race of intellectuals to improve mankind and espoused ridding humanity of deviants, those “who have killed, committed armed robbery, kidnapped children, robbed the poor or seriously betrayed public confidence,” he wrote. The book, both praised and panned by critics, became a bestseller.

Tired of his sensational reports in the press, The Rockefeller Institute mandated Dr. Carrel’s retirement in 1938. In retirement, Dr. Carrel’s ultimate goal was to remake humanity by studying humankind

27

Edwards.com/ESR1 References: 1. Grocott et al. Perioperative increase in global blood flow to explicit defined goals and outcomes after surgery: a Cochrane systematic review. Br J Anaesth 2013 2. Giglio MT, Marucci M, Testini M, Brienza N. Goal-directed haemodynamic therapy and gastrointestinal complications in major surgery: a meta-analysis of randomized controlled trials. Br J Anaesth 2009; 103: 637–46 3. Dalfino L, Giglio MT, Puntillo F, Marucci M, Brienza N. Haemodynamic goal-directed therapy and postoperative infections: earlier is better. A systematic review and meta-analysis. Crit Care 2011; 15: R154 4. Corcoran T et al. Perioperative Fluid Management Strategies in Major Surgery: A Stratified Meta-Analysis. Anesthesia – Analgesia 2012 Edwards, Edwards Lifesciences, the stylized E logo and Enhanced Surgical Recovery are trademarks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners. © 2014 Edwards Lifesciences Corporation. All rights reserved. AR11710

Edwards Lifesciences | edwards.com

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In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / JANUARY 2015

BREAST CANCER jcontinued from page 1

the American College of Surgeons, eight well-known surgeons outlined the major advances in breast cancer from 2014, and made recommendations on how to improve care for patients.

Moderator Steven Chen, MD, MBA, a surgeon and vice president of clinical affairs at Avelas Biosciences, La Jolla, Calif., said, â&#x20AC;&#x153;If thereâ&#x20AC;&#x2122;s one message to be heard about breast surgery this year, it is that as breast cancer care gets to be increasingly complex, the need to work as

a team increases dramatically. Every step of the way has brought us closer to individualizing the right care for the right person, at just the right time, and to do that requires a team approach.â&#x20AC;?

Margins Margins were the biggest issue in breast cancer surgery in 2014. Last winter, the Society of Surgical Oncology and the American Society for Radiation Oncology issued consensus guidelines that set â&#x20AC;&#x153;no ink on tumorâ&#x20AC;? as the appropriate margin for surgery in women undergoing breast-conserving surgery (BCS) with

whole-breast radiation for stages I and II invasive breast cancer. The guidelines were based on a meta-analysis of margin width that showed no ink on tumor was associated with low rates of ipsilateral breast tumor recurrence (IBTR). At the same time, the slim negative margin has the potential to reduce re-excision rates, improve cosmetic outcomes and decrease health care costs.

Despite strong support from professional organizations, the no ink on tumor standard remains an uncomfortable one for many surgeons and pathologists, said Richard Gray, MD, co-director of

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the Breast Clinic at Mayo Clinic, Phoenix.

Even the authors of the meta-analysis acknowledged that there are gray areas when it comes to margins, Dr. Gray noted. Some of the studies included in the meta-analysis indicated that â&#x20AC;&#x153;close marginsâ&#x20AC;? are associated with higher rates of recurrence; however, those studies failed to define close margins.

Even so, no ink on tumor is a â&#x20AC;&#x153;reasonable step,â&#x20AC;? Dr. Gray said, adding that he was initially concerned about the new standard.

He cautioned that there are caveats to the no ink on tumor specification. Some patients with invasive breast cancer, particularly younger women or patients with multiple close margins, may be candidates for wider margins, he said. â&#x20AC;&#x153;Keep in mind that no ink on tumor is a good place to start, given the caveats of appropriate multidisciplinary care.

There will be patients that should be an exception to this rule and you need to use judgment.â&#x20AC;?

The guidelines do not address patients with ductal carcinoma in situ (DCIS), for whom appropriate margin width remains controversial. A widely cited meta-analysis published in 2012 concluded that â&#x20AC;&#x153;negative surgical margins should be obtained for DCIS patients after BCS regardless of radiotherapy. Within cosmetic constraint, surgeons should attempt to achieve negative margins as wide as possible in their first attempt ((J Natl Cancer Inst 104:507-516).

The authors reported that compared with a negative margin of greater than 2 mm, a 10-mm free margin was associated with a reduced risk for IBTR (odds ratio [OR], 0.46; 95% confidence interval [CI], 029-0.69).

However, there is support for a narrow margin in patients who undergo radiotherapy. A 2009 meta-analysis that was restricted to clinical trials of women with DCIS who underwent BCS plus radiotherapy found that a margin threshold of 2 mm â&#x20AC;&#x153;seems to be as good as a larger margin when BCS for DCIS is combined with radiotherapyâ&#x20AC;? (J ( Clin Oncol 2009;27:1615-1620).

Dr. Gray recommended a 2-mm margin for patients with DCIS who undergo radiation, but he added, â&#x20AC;&#x153;Wider margins may be a single factor among others that can make us look toward avoiding radiation therapy in select patients.â&#x20AC;?

While no evidence suggests that margins that extend beyond no ink on tumor may be better for women undergoing

In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / JANUARY 2015

mastectomy, Dr. Gray cautioned against extrapolating the guidelines to women having mastectomies. “They will generally not undergo adjuvant radiation therapy,” he said.

After Mapping of the Axilla: Radiotherapy or Surgery?

Roshni Rao, MD, associate professor of surgery at University of Texas Southwestern Medical Center, Dallas, said she expects surgeons will perform fewer axillary lymph node dissections after the report from the AMAROS trial this fall (Lancet Oncol 2014;15:1303-1310).

In the Phase III, open-label, multicenter, noninferiority trial, patients with T1-2 primary breast cancer and no palpable lymphadenopathy were randomized to either axillary lymph node dissection (ALND) or axillary radiotherapy in the case of a positive node.

The study, which included 1,425 patients with a positive sentinel node, showed no significant difference in rates of recurrence between the groups. At a median follow-up of 6.1 years, 0.43% of women who underwent ALND developed a local recurrence compared with 1.19% of women who received axillary radiotherapy.

There was a significant difference in morbidity between the groups. Signs of lymphadenopathy were noted at five years in 23% of patients who underwent ALND, but only 11% of those treated with axillary radiotherapy.

“In our opinion, if further axillary treatment is needed in clinically node-negative, sentinel node–positive patients, axillary radiotherapy could be chosen instead of axillary lymph node dissection because it provides comparable axillary control,” the authors concluded.

This is the third study to conclude that axillary radiotherapy is noninferior to ALND. However, the two previous studies—the NSABP-04 trial and a French trial—were conducted before the introduction of sentinel node biopsy (N ( Engl J Medd 2002;347:567-575; J Clin Oncol 2004;22:97-101).

Dr. Rao said the latest study confirms that surgery unquestionably increases morbidity but without measurable benefits in potential recurrence. “I think we can say, ‘axillary lymph node dissection, rest in peace.’”

“In the past, it made sense to remove the lymph nodes so we could figure out what other treatments a patient may need. But nowadays, we can look at molecular profiling to help us make those decisions.”

Rising Rates of Contralateral Prophylaxis Swati

Kulkarni,

MD,

associate

professor of surgery at the University of Chicago’s Pritzker School of Medicine, called on surgeons to do a better job of communicating risk to breast cancer patients.

“We’re not explaining to them what their risk of contralateral breast cancer really is. We’re not taking the time to explain to them their risk of local recurrence, distant metastases and that a prophylactic surgery does not reduce that risk,” she said. “Take the time you need to educate your patients because we find that patients significantly overestimate the risks.”

She cited recent studies showing that women in the United States are undergoing contralateral prophylactic mastectomy (CPM) in ever-increasing numbers, despite a lack of strong evidence that this reduces the risk for contralateral cancer.

A study in the September edition of the Journal of the American Medical Association reported that the rate of bilateral mastectomies rose from 2.0% in 1998 to 12.3% in 2011, representing an annual increase of 14.3% (312:902-914). The rise was most pronounced in young women: In women younger than 40 years, bilateral mastectomies jumped from 3.6% in 1998

to 33% in 2011.

But there is little scientific justification for CPM’s popularity, Dr. Kulkarni said. Outcomes for breast cancer patients improved over the past two decades while contralateral breast cancer rates dropped.

A 2011 study using Surveillance, Epidemiology, and End Results (SEER) data showed that incidence of contralateral breast cancer dropped substantially between 1975 and 2006 (J ( Clin Oncol 2011;29:1564-1569). Since 1985, contralateral breast cancer rates fell about 3% annually in the United States, a trend see BREAST CANCER page 30

Read the #1 general surgery publication in the country anywhere, anytime.

29

30

In the News BREAST CANCER jcontinued from page 29

driven largely by improvements to treatment of estrogen receptor (ER)-positive cancers, such as widespread use of adjuvant hormone therapy and other adjuvant treatments.

It is unclear whether CPM confers a survival advantage, Dr. Kulkarni said. A 2010 Cochrane analysis found “insufficient evidence that CPM improves survival” (Cochrane Database Syst Rev 2010:CD002748). But a retrospective study, also from 2010, reported that CPM was associated with a 4.8% absolute improvement in five-year breast cancer–specific survival in young women with early-stage, ER-negative breast cancer (J ( Natl Cancer Inst 2010;102:401-409). More recently, the California Cancer Registry study that showed rising rates of CPM also demonstrated that women who receive this procedure derive no survival benefit from the extra surgery.

Few studies have examined short-term outcomes after CPM, Dr. Kulkarni said. A study published in late 2013 reported that CPM patients were 1.5 times more likely to have any complication (OR, 1.53; 95% CI, 1.04-2.25; P P= 0.029) and 2.7 times more likely to have a major complication compared with unilateral mastectomy patients (OR, 2.66; 95% CI, 1.37-5.19; P=0.004), P after adjusting for age, body mass index, smoking and diabetes history, American Joint Committee on Cancer stage, reconstruction, previous radiation therapy and adjuvant therapy (Ann ( Surg Oncol 2013;20:4113-4120).

Dr. Kulkarni urged surgeons to talk to patients about risks for contralateral breast cancer and question them about factors important in their decision.

Neoadjuvant Hormone Therapy E. Shelley Hwang, MD, professor of surgery at Duke University School of Medicine, Durham, N.C., urged surgeons to consider neoadjuvant hormone therapy, particularly for older patients or patients with comorbidities that rule out use of chemotherapy.

“Neoadjuvant hormonal therapy can improve your lumpectomy rate in these patients by up to 40%,” she said.

Three key studies have looked at neoadjuvant hormone therapy in women with breast cancer: the P024 trial, the IMPACT study and ACOSOG Z1031. Together, these studies showed that neoadjuvant hormone therapy can improve a woman’s candidacy for BCS and that her response to hormone therapy is closely associated with ER expression. Among the highlights, the P024 trial reported that up to 45% of patients who were initially not eligible for lumpectomy became candidates for BCS after four months of letrozole ((Ann Oncol 2001;12:15271532). Even with tamoxifen, considered a less effective form of hormone therapy, 35% of women became good candidates for lumpectomy. “That is the important message for surgeons from this trial,” Dr. Hwang said.

Both the P024 and IMPACT trials showed that aromatase inhibitors generally provide a better response in ER-positive disease than tamoxifen.

Dr. Hwang recommended that surgeons use the Preoperative Endocrine Prognostic Index (PEPI) score to make decisions about treatment. First reported in 2008, the PEPI score predicts the risk for breast cancer recurrence in women who received neoadjuvant hormone therapy by looking at four breast cancer characteristics: pathological tumor stage, nodal status, Ki67 expression level and ER status (J ( Natl Cancer Instt 2008;100:13801388). A woman’s PEPI score may help identify whether she can safely avoid chemotherapy or if she should be considered for aggressive therapy because of a high

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / JANUARY 2015

On Margins ‘Keep in mind that no ink on tumorr is a good place to start, given the caveats of appropriate multidisciplinary care. There will be patients that should be an exception to this rule and you need to usee judgment.’

—Richard Gray, MD

On Axillary Dissection ‘I think we can say, “axillary lymph node dissection, rest in peace.”’

—Roshni Rao, MD

On Contralateral Prophylactic Mastectomy ‘We’re not taking the time to explain to [patients] their risk of local recurrence, distant metastases and that a prophylactic surgery does not reduce that risk.’

—Swati Kulkarni, MD

On Neoadjuvant Endocrine Therapy ‘Neoadjuvant hormonal therapy can improve your lumpectomy rate in [older patients or patients with comorbidities] by up to 40%.’

—E. Shelley Hwang, MD

On Intraoperative Radiation ‘Overall, I would say that whole-breast radiotherapy is still the gold standard. We are still learning who the best candidates for intraoperative radiotherapy may be.’

—Courtney A. Vito, MD

On Genetic Testing ‘It requires a good discussion with the patient and the family members to make a decision, and this is best done in the context of someone who has experience with these types of panels.’

—Doreen M. Agnese, MD

risk for relapse.

A new Phase III study (ACOSOG Z11103), which opened a few months ago, aims to identify patients with ER-positive tumors that do not require chemotherapy despite being a large size. Results from the trial, known as ALTERNATE, are not expected for several years.

The Case for Intraoperative Radiation Although whole-breast radiation remains the standard, evidence is building for targeted intraoperative radiotherapy, said Courtney A. Vito, MD, assistant clinical professor and staff surgeon at City of Hope Comprehensive Cancer Center, Duarte, Calif.

Since 2013, two trials that compared targeted breast radiation and whole-breast radiotherapy have demonstrated that the targeted approach may be advantageous.

In November 2014, investigators reported five-year results from the TARGIT-A trial, which randomized women older than 45 years with invasive ductal carcinoma to receive single-dose targeted intraoperative radiotherapy (TARGIT) or fractionated external beam

radiootherapy (EBRT). The patients were enrrolled at 33 centers in 11 countries, beetween 2000 and 2012.

When TARGIT was performed cooncurrently with lumpectomy, the fiive-year risk for local recurrence was coomparable to that of EBRT: 2.1% verrsus 1.1%. But when TARGIT was delaayed and performed after lumpectomy, recurrences occurred in 5.4% of patients, a rate much higher than that for whole-breast radiation.

In a second significant finding from the trial, breast cancer mortality was reported to be the same in the two groups, but there were significantly fewer non–breast cancer deaths with TARGIT, at 1.4% versus 3.5 % with EBRT. Much of the difference was attributable to fewer deaths from cardiovascular causes.

“Whole-breast radiation when applied to the left side of the chest can accelerate atherosclerosis of the heart.

This does not imply that the external beam caused the cardiac death but there is more room for study here,” Dr. Vito said.

A 2013 study also indicates a role for targeted intraoperative radiotherapy. Five-year results of the Electron Intra Operative Radiation Therapy (ELIOT) trial showed no difference in overall survival between women treated with whole-breast external radiotherapy or intraoperative radiotherapy with electrons (Lancet Oncoll 2013;14:1269-1277). However, there was a substantial disparity in IBTR. Five years after treatment, 4.4% of women in the intraoperative radiotherapy group developed a recurrence compared with 0.4% in the EBRT group (OR, 9.3; 95% CI, 3.3-26.3).

But subset analyses demonstrated that most recurrences were in women who would not be considered candidates for intraoperative radiotherapy in the United States because they had tumors larger than 2 cm, four or more positive lymph nodes, ER-negative tumors or other aggressive tumor biology.

“Without this high-risk group, the data look a lot better,” Dr. Vito noted.

“Overall, I would say that whole-breast radiotherapy is still the gold standard. We are still learning who the best candidates for intraoperative radiotherapy may be,” she said. “Clearly, application to a wide spectrum of patients is not advised. I would recommend patients who undergo this do so with a comprehensive breast cancer team and preferably on [a] trial, and they need very close long-term follow-up.”

Genetic Testing Doreen M. Agnese, MD, associate professor of surgical oncology and human genetics at Ohio State University, and chief of surgical services at James Cancer Hospital, Columbus, said surgeons should undergo training in genetics or work closely with health care providers who have training in cancer genetics.

It is becoming increasingly complicated to select the appropriate genetic tests for breast cancer patients and to counsel patients accordingly, she said. Today, many companies offer gene panels, with prices ranging from $1,500 to $6,000, depending on the number of genes analyzed.

“It requires a good discussion with the patient and the family members to make a decision, and this is best done in the context of someone who has experience with these types of panels,” Dr. Agnese said.

Dr. Hwang disclosed an advisory role for Genomic Health.

Opinion

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / JANUARY 2015

The Day Medicine Stood Still Facing the Challenge of A Tech-Failure Event P ETER J. P APADAKOS , MD

I

n the classic science fiction film, “The Day the Earth Stood Still,” the planet comes to a panic-stricken stop when electricity is shut off by an advanced alien force.

Hospitals and health care facilities for the past several decades have developed backup electrical generation and protocols that are regularly drilled in the event of power emergencies. Over the past several years, however, major natural disasters, such as Hurricane Sandy, and major regional power and computer failures have identified a new danger.

As medicine in just the past five years has become more dependent on computer-based systems such as electronic medical records (EMRs), automated vital sign downloads, central lab data and digital image libraries, and computer-based pharmacy ordering, a new Achilles’ heel has been identified in patient care and safety—the fragile nature of this digital infrastructure.

Most health care facilities and hospitals do not have a well-developed protocol on what to do for such system failures, or regularly drill staff to prepare them.

There is no internal emergency backup technology in existence for such events.

Staff is crippled without these instruments and “smart” devices. Younger staff who have been trained in today’s technology-based world are the most vulnerable. Such disasters have brought to the forefront how these tech-savvy individuals cannot adapt and provide quality, safe care without appropriate alternative training. Indeed, in certain scenarios, they would be crippled. For example, how does one get a patient history without an EMR problem list? How does one record vital signs nondigitally?

What is the dosage of a commonly used drug without a computer-based checklist or pharmacologic ordering library?

Care providers are unable to know the history or medical care received by critically ill patients when they may need transfer to a safer area out of reach of a natural event, such as a tornado or flood.

Hospitals may not even be able to call in emergency help or hospital leadership because emergency phone contact algorithms may be stored in the computer software or on the Internet, both of which would be down. Such basic things as contacting the families of patients to

inform them of transfers grind to a halt when the screen turns blue.

How can we safeguard our patients and health care infrastructure from the threat of such natural and technology-based disasters? The keystone is developing an emergency plan to react to such events, and develop and carry out regular training and drills. Each patient care area should have unit-specific supplies, such as order sheets, progress notes and reference books to make

dosing and pharmacologic data available in the event of such emergencies. One computer and printer should be plugged into the emergency power system; on this device, a summary Word document containing key sign-out information, history and family contact data should be kept so that care and possible transfer information can be generated seamlessly. The hospital and each specific medical unit should also keep a log with emergency contact information

•

2015

of key staff who can be reached by landline or cell phone to aid in the emergency. Hospitals and technology companies should develop devices that will provide emergency backup to these Internet-based medical technologies, so that EMRs can function in emergency mode, ideally on backup power.

Regarding staff education, because new young staff may not be versed in pre-technology patient care, regular see TECHNOLOGY page 32

•

The American Society of Colon and Rectal Surgeons

Annual Scientific Meeting May 30 - June e 3, 2015 H nes Convention Center & Sheraton Hyn n Boston Ho otel

Program available online in February at www.fascrs.org

31

32

In the News TECHNOLOGY

jcontinued from page 31 education and drills should reinforce how to safely care for patients in a low-tech environment. Staff should be taught how to gather data by phone from labs, radiology, etc.; protocols on how to communicate information without computers should be taught, along with the use of paper-based record keeping and ordering. Patient interactions for gathering history and recording physical findings without computer-stored data and checklists should be practiced.

Hospital- and department-based preparation and regular drills, including

ETHICS

AND

ROBOT

jcontinued from page 1

a panel session on surgical ethics and new technologies at the 2014 Clinical Congress of the American College of Surgeons (ACS). Surgeons in the audience were asked to consider an ethical dilemma and answer a series of questions. Then, surgeons and ethicists weighed in on the debate.

Here, General Surgery Newss presents one ethical scenario. Answer the questions and read on to see what ethicists and other surgeons had to say.

The Scenario Jane Pepper is a 56-year-old woman who has multiple uterine fibroids and pelvic pain.

She is meeting with her gynecologic surgeon to discuss treatment options. The surgeon offers her a robotic hysterectomy, explaining that the recovery from surgery is faster and that cosmesis is better than with open or laparoscopic surgery. Ms. Pepper is quite interested in robotic surgery. She has seen the hospital billboards in town advertising the hospital’s investment in this innovative technology and has read online that robotic hysterectomy is frequently painless and offers significant advantages over traditional hysterectomy. Ms. Pepper’s health insurance is sponsored by her employer. Her contribution to this plan is $750 per month. When robotic procedures are performed at the surgeon’s hospital, there is a $6,000 surcharge for use of the robot added to the patient’s bill. This will likely be covered by Ms. Pepper’s insurer, given that the surgeon’s and hospital’s experience has been similar in the past.

Questions 1. What should the surgeon do?

• Use the robot without discussion of these additional surcharges.

• Describe the additional charges to Ms. Pepper.

• Offer at least a less expensive alternative.

2. Should the patient’s excellent health

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / JANUARY 2015

brainstorming sessions, should allow for improvement and growth. Staff will thus feel comfortable in a techfailure event and be able to communicate professionalism with patients and their families, who will also be affected by area-wide disasters. Through such training, communities will know that, like other basic emergency services that provide aid in times of crisis, the provision of health care will remain intact.

—Dr. Papadakos is director of critical — care medicine at the University of Rochester Medical Center, in Rochester, N.Y. He lectures on the impact of technology on medical care.

insurance figure into this treatment decision?

• Yes • No

Ethical Considerations The scenario should be evaluated by the four principles of Beauchamp and Childress in “Principles of Biomedical Ethics,” principles that form the standard framework for analyzing ethical situations in medicine: autonomy, beneficence, nonmaleficence and justice.

That said, the key issues at hand are a patient’s right to make his or her own choice about medical care; the principle that a physician should act with the best interest of his or her patient in mind; the principle that physicians should do no harm; and an emphasis on fairness and quality among individuals.

Using these four principles, it is not always clear how cost should factor into informed-consent discussions, said Peter

Most health care facilities and hospitals do not have a well-developed protocol on what to do for such system failures, or regularly drill staff to prepare them.

bear additional costs or the complete cost of a surgery, then disclosure of the cost and potential financial harm is “absolutely relevant,” he said.

In contrast, in cases where there is no evidence to show improved outcomes with robotic surgery, “this should be disclosed as well, and a clear discussion of risks and benefits needs to be undertaken,” Dr. Angelos said.

Emily C. Bellavance, MD, assistant professor of surgery, University of Maryland’s Marlene and Stewart Greenebaum Cancer Center, in Baltimore, said studies have shown that as many as 30% of publicly and privately insured patients experience financial burdens and stress as a result of medical care.

There’s a term for it in oncology— “financial toxicity”—a reference to the fact that out-of-pocket expenses can erode a patient’s quality of life and become an adverse event of treatment. Recent surveys of cancer patients have shown that

‘Financial side effects are relevant, both to her life and her health. There’s a reason why the World Health Organization defines “health” as “a state of complete physical, mental and social wellbeing, not merely the absence of disease or infirmity.”’

—Emily C. Bellavance, MD Angelos, MD, PhD, chief of endocrine surgery and associate director of the MacLean Center for Clinical Medical Ethics, University of Chicago.

“The ethical responsibility we have as physicians is to provide the highest quality with the greatest efficiency or the lowest cost. I would suggest there is an ethical imperative to benefit each patient to the greatest extent possible,” he said.

“If using a robot leads to greater or better outcomes, then the cost to the insurance company should be a secondary concern.”

But when a patient could be asked to

patients frequently alter their care because of financial burdens, such as skipping prescriptions (28%) and taking less medication than prescribed (23%) (2014 Palliative Care in Oncology Symposium, Boston; abstract 161).

In this particular scenario, it’s not clear whether Ms. Pepper will experience financial stress because the surgeon does not know with certainty what her out-ofpocket costs will be, even though the surgeon’s past experience indicates the full cost will be covered.

If there’s any chance that expenses

could be passed on to Ms. Pepper, her physician must discuss the costs of her operative options, according to the principles of beneficence and non-maleficence, Dr. Bellavance said.

“Financial side effects are relevant, both to her life and her health. There’s a reason why the World Health Organization defines ‘health’ as ‘a state of complete physical, mental and social wellbeing, not merely the absence of disease or infirmity.’”

Dr. Bellavance argued that costs should be included as part of an ethically sound informed consent regardless of a patient’s insurance status. Because patients today have the autonomy to make active decisions about their care, surgeons should give patients the financial rundown on their options, along with clinical information.

It’s important to remember that physicians do not always share their patients’ views when it comes to cost and value in health care, said several surgeons in the audience.

“Everyone has their own sense of what’s important to them. It’s important that we realize we don’t know what is significant to our patients unless we have those conversations,” said Matthew Mell, MD, associate professor of surgery, Stanford University Medical Center, Stanford, Calif.

Eric A. Singer, MD, MA, assistant professor of surgery and urologic oncology surgeon at Rutgers Cancer Institute of New Jersey, in New Brunswick, argued that cost is not relevant in this particular informed-consent discussion. There are two reasons why costs should not be raised in this case: The patient has private insurance that will cover her robotic procedure, and she does not have cancer, so there is no risk for costs incurred by chemotherapy, radiation or lifelong treatment.

Patients are entitled to receive all the benefits they pay for, he said. “A patient can certainly decide between each of the surgical options, but I’m not really sure

In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / JANUARY 2015

why cost would factor in, in this scenario, when thereâ&#x20AC;&#x2122;s no difference in the cost to her.â&#x20AC;?

Dr. Singer contended that financial toxicity does not apply in this scenario. The patient needs one operation that will not result in out-of-pocket expenses. â&#x20AC;&#x153;Financial toxicity is not a concern in this particular instance.â&#x20AC;?

He stressed that the surgeonâ&#x20AC;&#x2122;s fiduciary obligation is for the patient, not the patientâ&#x20AC;&#x2122;s insurance company.

Dr. Singer also made the point that broader adoption of new technology can have benefits to the health care system.

For example, as robotic surgery becomes more widespread, the costs are likely to decrease as operating room teams become more efficient and complication rates fall, he said.

He cited a 2013 study from surgeons at Columbia University, in New York City, that compared robotically assisted and laparoscopic hysterectomy among women with benign gynecologic disease ( (JAMA 2013;309:689-698). The group included 264,758 women who underwent hysterectomies for benign gynecologic disorders at 441 hospitals across the United States, between 2007 and 2010.

Use of robotically assisted hysterectomy increased from 0.5% in 2007 to 9.5% in 2010. During the same period, laparoscopic hysterectomy rates increased from 24.3% to 30.5%.

A propensity scoreâ&#x20AC;&#x201C;matched analysis revealed that the overall complication rates were comparable between roboticassisted and laparoscopic hysterectomy (5.5% vs. 5.3%; relative risk [RR], 1.03; 95% confidence interval [CI], 0.861.024). Patients who underwent a robotic-assisted hysterectomy were less likely to have a hospital length of stay longer than two days (19.6% vs. 24.9%), but transfusion requirements and rate of discharge to a nursing facility were similar.

The greatest difference between the robotic and the laparoscopic hysterectomy was cost, with robotic hysterectomies costing $2,189 more per case.

However, when hospitals and surgeons performed more robotic operations, the cost per robotic procedure dropped, Dr. Singer pointed out. â&#x20AC;&#x153;If you have highvolume surgeons at a high-volume center, you bend that cost curve down.â&#x20AC;?

Even so, the authors of the study came down in favor of the laparoscopic approach, noting that the robotic procedure offers little short-term benefit and is accompanied by significantly greater costs. They argued that from a public health standpoint, subsets of patients with benign gynecologic disorders who could derive benefit from robotic hysterectomy should be identified and the costs of robotic instrumentation need to be reduced.

Several surgeons said they were

concerned that cost issues would overshadow clinical benefit in informed-consent discussions. â&#x20AC;&#x153;My obligation in offering a particular procedure to a patient is what I think I can do best for that patient. If you start a conversation with, â&#x20AC;&#x2DC;well, thereâ&#x20AC;&#x2122;s a cheaper procedure,â&#x20AC;&#x2122; the patient may think that you are actually dissuading them from what you think is best on their behalf,â&#x20AC;? said one surgeon who commented from the meeting floor.

Also important issue in this scenario is hospital advertising, Dr. Angelos noted.

Ms. Pepper told her surgeon that

she had noticed the hospitalâ&#x20AC;&#x2122;s ads for robotic surgery. These ads are common throughout the United States. In a 2011 report in the Journal of Healthcare Quality, researchers described a study of 400 randomly selected U.S. hospital websites from June 2010, in which 41% described robotic surgery (33:48-52).

Of these, 37% presented robotic surgery on the home page; 73% used manufacturer-based stock images or text; and 33% linked to a manufacturer website.

No hospital website mentioned the specific risks associated with robotic surgery. The authors argued that materials

33

provided by hospitals regarding the surgical robot overestimate benefits, largely ignore risks and are strongly influenced by the manufacturer.

Dr. Angelos called for self-imposed standards for truthful advertising to patients. â&#x20AC;&#x153;This would be to everyoneâ&#x20AC;&#x2122;s benefit: [to] our patients, to us, to society.â&#x20AC;?

We would like your opinion.

Please send letters to: khorty@mcmahonmed.com.

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Part 3: A Multidisciplinary Approach to

2SWLPL]LQJ 6DIHW\ DQG (IÂżFLHQF\ Case Study Brenda is a 78-year-old woman undergoing open abdominal surgery to correct symptomatic pelvic organ prolapse.

Current Symptoms Â&#x2021; Pelvic organ prolapse failing conservative therapy Vital Signs Â&#x2021; Height: 175 cm Â&#x2021; Weight: 85 kg 6LJQLÂżFDQW 0HGLFDO +LVWRU\ Â&#x2021; Dyslipidemia Â&#x2021; Type 2 diabetes mellitus Â&#x2021; Glaucoma &XUUHQW 0HGLFDWLRQV Â&#x2021; Ezetimibe Â&#x2021; Glyburide Â&#x2021; Insulin glargine Â&#x2021; Pravastatin Anesthesia is induced with fentanyl 100 mcg, propofol 150 mg, and rocuronium 50 mg and maintained with GHVĂ&#x20AC;XUDQH LQ DLU R[\JHQ $PSLFLOOLQ VXOEDFWDP 3 g is given intravenously as well. At 90 minutes after induction, the surgeon reports tension in the surgical ÂżHOG DQG UHTXHVWV DGGLWLRQDO UHOD[DWLRQ 1R PRQLWRULQJ of neuromuscular function is performed.

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34

In the News BARIATRIC COSTS jcontinued from page 1

Another study, a six-year follow-up of 30,000 obese patients who underwent bariatric surgery between 2002 and 2008 and a matched nonsurgical cohort, concluded that bariatric surgery does not reduce overall health care in the long term (JAMA ( Surgery 2013;148:555-562). Dr. Morton pointed out that this latter study predated the accreditation of bariatric surgical centers and use of the laparoscopic approach, both of which have demonstrated lower complications and costs. The study also had a follow-up rate of only 7%.

In the new study, investigators analyzed pharmacy costs from the MarketScan Commercial Claims and Encounters database for patients who had a diagnosis of obesity between Jan. 1, 2007 and Dec. 31, 2008. They compared data for patients who underwent laparoscopic bariatric surgery (laparoscopic gastric band or Roux-en-Y gastric bypass; n=2,700) and a cohort of similar matched patients who did not (n=2,700), with 100% follow-up at four years. This nationwide database contains data for approximately 56 million covered lives from all 50 states.

In their sample, the investigators did not include patients if they had evidence of inflammatory bowel disease, familial adenomatous polyposis, noninfectious colitis, cancer of the digestive organs or peritoneum during the year before the index period. Patients had

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / JANUARY 2015

After adjusting for pre-index pharmacy costs and comorbidities, pharmacy costs were 22.6% lower for surgery cases than controls at four years post-index. to be continuously enrolled in a health insurance plan from one year pre-index period to four years post-index. The two patient groups were similar, but individuals who had the surgery had higher rates of cardiovascular disease (65.9% vs. 56.7%), acid reflux (24.7% vs. 11.1%) and sleep apnea (39.6% vs.

18.7%).

Patients in the surgery group had higher total pharmacy costs at one year after surgery or post-index year ($3,098 vs. $2,303), but lower costs in the next three years. At four years, prescription drug costs were $8,411 for patients who had bariatric surgery and $9,900 for those who did not. After adjusting for pre-index pharmacy costs and comorbidities, pharmacy costs were 22.6% lower for surgery cases than controls at four years post-index (cost ratio, 0.774; 95% confidence interval, 0.728-0.821; P<0.0001).

Reductions were driven by lower antidiabetic, antihypertensive and cardiovascular drug prescription costs.

Whereas the proportion of patients receiving cardiovascular prescriptions

declined among those who had surgery from one year to four years post-index (42% vs. 40%), it increased among nonsurgical patients (34% vs. 46%). The same trend was seen for antihypertensive prescriptions (surgery, 66% to 59%; no surgery, 59% to 70%) and antidiabetic prescriptions (surgery, 34% to 21%; no surgery, 30% to 38%).

According to Dr. Morton, the firstyear increase for the surgery group was likely attributable to medications that patients sometimes receive after surgery, such as pain medicines and proton pump inhibitors. “Whatever cost savings there were around diabetic medications or high blood pressure medications were lost because of those other medications,” Dr. Morton said.

Bariatric surgery also affected the total number of prescription drugs used by patients. After multivariate

adjustments, at four years post-index, the number of antidiabetic prescriptions was 74% lower among surgery cases than nonsurgical cases. Similar trends were seen for the number of antihypertensive prescriptions (48.3% lower) and number of cardiovascular prescriptions excluding antihypertensives (48.9% lower).

“It is likely that additional medication cost savings may be maintained years following surgery,” Dr. Morton said.

According to Robin Blackstone, MD, medical director of Scottsdale Healthcare Bariatric Center, in Scottsdale, Ariz., who was not involved in the study, the research is extremely relevant.

“We are all anxious to prove the value of bariatric surgery,” she said, noting that the study established its effectiveness in reducing medication costs.

Dr. Morton said he expected the Affordable Care Act to increase the rates of bariatric surgery. Only 22 states cover bariatric surgery, but a joint initiative from ASMBS and the American College of Surgeons will address expanding coverage to all 50 states.

According to Dr. Morton, his study provides evidence that this expansion will be valuable.

Dr. Morton is a consultant for Covidien and a speaker for Ethicon. Dr. Blackstone is a consultant for Johnson & Johnson and was a principal investigator for an Enteromedics research study.

Weight Loss Surgery May Not Worsen Outcomes in Acute Pancreatitis B Y M ONICA J. S MITH PHILADELPHIA—People who have had bariatric surgery tend to be at increased risk for gallstones, and as a result, developing pancreatitis. However, new research shows that this subset of patients with acute pancreatitis (AP) have no greater risk for mortality from the condition and often have shorter lengths of stay in the hospital a and use fewer health care resources.

“Bariatric surgery has become increasingly common, especially in the last decade. These patients have higher risk of gallstones, and as most of us know, endoscopic access is difficult due to the altered anatomy, particularly in those who have had Rouxen-Y gastric bypass surgery,” said Somashekar Krishna, MD, MPH, assistant professor in the Department of Gastroenterology, Hepatology and Nutrition at The Ohio State University Medical Center, in Columbus.

“At this time, there are no large population studies, either in the United States or outside, evaluating the association between AP and prior bariatric surgery.”

Dr. Krishna and his colleagues presented their findings at the 2014 meeting of the American College of Gastroenterology (abstract 50).

The researchers consulted the Nationwide Inpatient Sample for 2007 through 2011, using diagnostic codes to identify all patients admitted with a primary diagnosis of AP and all those who underwent bariatric surgery and received a primary diagnosis of AP. Univariate analysis was used to compare demographics, hospital factors and causes of AP, and a multivariate analysis compared complications, mortality and health care utilization in terms of length of stay (LOS) and total hospital charges.

The study found an increase in both hospital admissions for AP and number of patients who underwent weight loss surgery, a figure that doubled during the five-year period. “In parallel with these two trends, there was an increasing prevalence of prior bariatric surgery among those admitted with acute pancreatitis,” Dr. Krishna said.

During the study period, among the 1.35 million patients admitted for AP, the proportion of patients who had also undergone bariatric surgery grew from 0.73% to 1.39% (P=0.001).

P Univariate analysis comparing surgery patients with the control group found that the former tended to be younger, more often female and to have private insurance. “Further, they had more frequent gallstones

and needed more cholecystectomies,” Dr. Krishna said.

“We observed that these patients had more frequent non-endoscopic biliary access compared with the control group, and had fewer [endoscopic retrograde cholangiopancreatography procedures], again showing difficulty in access.”

Multivariate analysis found no association between bariatric surgery and increased mortality. “Further, the linear regression analysis showed they had a shorter LOS and incurred fewer hospital charges,” Dr. Krishna said.

These findings were strengthened by a propensitymatched analysis of nearly 3,000 matched pairs of patients.

A possible explanation for the association between weight loss surgery and equivalent or better outcomes in AP may have to do with the effect of postsurgical weight loss on inflammation, Dr. Krishna said.

“Obesity, which is a proinflammatory state, is associated with both severity and mortality in acute pancreatitis. There is evidence showing that those who have weight loss after bariatric surgery do have a decrease in these proinflammatory mediators. Whether this translates to better outcomes in AP remains to be studied,” he said.

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Opinion

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / JANUARY 2015

AMNESTY

FOR

jcontinued from page 1

ACA

ACA

more cunning than accidental. One got the sense of a purposeful intent to deceive, or a failure to disclose. Jonathan Gruber’s recent comments verify this. Mr. Gruber is a professor at Massachusetts Institute of Technology, the architect of the ACA and speaker of the stunning admission that the bill was written “opaquely” to disguise the fact that, in essence, health care reform was a huge redistribution scheme that no one would support if it explicitly stated that the intent was to subsidize care for the poor by forcing others to buy expensive policies with bells and whistles that few needed.

Could anything be worse than to hear the Speaker of the House say, “I don’t know what’s in the bill,” or one of its authors say, “You can’t tell what’s in the bill” because it was intentionally written to confuse?

Yes. “It doesn’t matter what’s in the bill.”

That’s worse. Much worse.

“It doesn’t matter what’s in the bill” is the same thing as saying “the law is what we say it is.” If that isn’t scary enough, just add the words, “what we say it is can change at any time.” One can argue whether or not President Obama acted within the Constitution and the scope of his executive authority the other night when he lifted the threat of deportation against people illegally in this country, but what matters is that he repeatedly told us he had no legal or Constitutional authority to do so. But he did it anyway. and appeared quite pleased with himself for doing a noble thing. Moral authority trumped legal authority that can be manipulated.

Was it this same dismissive attitude toward the law that informed the writing of the ACA and its circuitous movement through the legislative process? Had the president and his agents intended all along to get anything passed and then worry about what was in it later, knowing full well that implementation could always be reshaped by broad interpretation or selective enforcement of its provisions? Are we living in an age where the black letter of the law is nothing more than license to act independently, arbitrarily, or worse, for political gain? That’s what TSVBMC [the still very beautiful Mrs. Cossman] says, and she’s got the law degree, not me.

Mr. Gruber admitted that when the bill was being written, the framers were instructed to put everything in it (hence its length), but disguise its true purpose of wealth redistribution from the voter and its cost from the Congressional Budget Office.

More cynically, it appears the law was intentionally deceptively written as

37

a center-right document designed to embarrass Republicans who would inevitably vote against it along strict partisan lines. The personal mandate and the insurance exchanges to enhance competition in the marketplace are both conservative ideas lifted directly from the Hoover Institute, a conservative think tank that advised none other than Massachusetts Governor Mitt Romney in his implementation of the state plan, upon which the ACA was modeled. Odd that Gov. Romney ran against his own plan, but politics poisons principles every time. To embarrass themselves further, conservatives asked the U.S. Supreme Court to strike down the personal mandate, the symbol of personal responsibility and accountability endorsed by conservatives. Chief Justice John Roberts, one of their own, saw the paradox and struck them down.

If the Republicans were stupid for voting against it, what can we say about the Democrats who all voted for it? Where was all the promised reform? What about a single payor and universal coverage?

Wasn’t the purpose of “health care reform” in the first place to rein in the insurance industry that was extracting billions from health care through managed care products like health maintenance organizations that coined money by rationing care? Not only is there nothing in the ACA to constrain the insurance companies, they are making out like bandits. Far from being a federal reform of health care, the ACA has resulted in a virtual takeover of health care by the insurance industry.

Look at the numbers since ACA went live. The four major players—Aetna,

Not only is there nothing in the ACA to constrain the insurance companies, they are making out like bandits.

Far from being a federal reform of health care, the ACA has resulted in a virtual takeover of health care by the insurance industry.

Humana, United Healthcare and Cigna—have seen their profits double in two years and their market caps rise nearly 70% on the New York Stock Exchange.

Some of the profits have come from millions of new enrollees in managed Medicaid plans, in which profits are high and reliable because the premiums are 100% subsidized by the U.S. Treasury. A second massive wave of new enrollees into the exchanges came from people who lost their cheaper nonconforming plans despite the president’s pledge that this would not happen. They were greeted with sticker shock. Mr. Gruber has stated the president knew this when he told Americans that the average family of four would see $2,500 in savings the first year.

The insurance companies saw this coming and got on board early. The Harry and Louise ads that they sponsored to kill off the Clinton health care plan in the 1990s stayed in storage. Besides, Harry and Louise are now on Medicare enjoying free federally sponsored health care.

But wait, there’s more! As an added bonus, the ACA would create a virtual monopoly for the five or six largest insurance companies by forcing the small to mid-sized firms selling unqualified products out of business. How great was that, the federal government creating instead of prosecuting monopolies!

Other big businesses are taking note and re-evaluating their traditional antigovernment postures. There’s a lot of money to be made from big government with big plans that it can’t execute. Saving face gets expensive. Warren Buffett is no dummy: He’s doing quite nicely with the anti–Big Business crowd in power. Even excessive government regulation is being revisited as ultimately being pro–Big Business because it poses hopelessly complex and expensive barriers to entry for smaller competitors. Politicians love regulations because of all the campaign contributions this brings in to get around them.

Big Business is starting to love them because smaller competitors can’t afford compliance or lobbying for a variance.

The monumental government failure on opening day was an unexpected bonanza for the insurance companies.

What was running through the minds of the CEOs of the Big Four when the president, Department of Health and Human Services (HHS) Secretary Sebelius and the hapless technocrats came crawling on hands and knees, begging for help to launch healthcare.gov that was four years and $2 billion in the making? Apparently, the federal labor pool of 25 million was insufficient to launch a website, so the see AMNESTY FOR ACA page 38

38

Opinion AMNESTY

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / JANUARY 2015

FOR

jcontinued from page 37

ACA

insurance industry graciously supplied executive and technical personnel. An obvious conflict of interest was waived by the government, so the insurance industry is now basically running HHS. But wait, thereâ&#x20AC;&#x2122;s even more! Health care reform was supposed to move to a single-party payor; ACA didnâ&#x20AC;&#x2122;t do that. It was supposed to insure everyone; it didnâ&#x20AC;&#x2122;t do that. It was supposed to control costs so that health care didnâ&#x20AC;&#x2122;t consume 16% of the gross domestic product; it didnâ&#x20AC;&#x2122;t do

that either, but there is one provision of the ACA that was supposed to be a step in that direction, but when all is said and done, it will more likely than not just be another huge profit engine for the insurance industry.

The ACA provides for a little-known $3 billion â&#x20AC;&#x153;pilot projectâ&#x20AC;? to fund â&#x20AC;&#x153;outcome studies.â&#x20AC;? Outcome studies in the context of the ACA are studies that compare the relative effectiveness of different treatments for diseases and conditions. Itâ&#x20AC;&#x2122;s not an exact science in that effectiveness takes into account the â&#x20AC;&#x153;therapeutic indexâ&#x20AC;? or the length of time that a treatment, when

successful, is beneficial. Let me translate that for you: If youâ&#x20AC;&#x2122;re an old person, say over 75, donâ&#x20AC;&#x2122;t expect to get a total hip because you wonâ&#x20AC;&#x2122;t be alive long enough to enjoy it. Take Advil instead. Total hips are for younger people who donâ&#x20AC;&#x2122;t need them.

Thatâ&#x20AC;&#x2122;s outcome analysis and the therapeutic index in a nutshell.

Of course, the ACA explicitly states that outcome studies cannot be used for payment decisions. Enter once again our good friend and tour guide Mr. Gruber, who explains with a wink and a nod that it would be a mistake to think that the law would interfere with action deemed

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necessary to serve a higher purpose. If the president can act in a way he repeatedly described as illegal to end deportations, Humana should have little trouble telling me Iâ&#x20AC;&#x2122;m not getting covered for a carotid thromboendarterectomy because maximum medical therapy works as well, or well enough, or sufficiently well given the price difference. If providers (formerly known as doctors) arenâ&#x20AC;&#x2122;t getting paid, they will change their behavior in the same way that tax preferences influence investment, saving and spending decisions. Throw in accountable care organizations (ACOs) so everyoneâ&#x20AC;&#x2122;s financial interests are aligned and surgeons will be getting year-end bonuses for doing the fewest cases. Weâ&#x20AC;&#x2122;ll see if the ortho guy from the ACO who still does a lot of total hips gets invited to the Christmas party.

And who benefits from using outcome analysis to deny payment? Not the patient; not the doctor; the insurance companies pocket the savings. If underwriting losses go up, they disproportionately raise premiums. If they go down, they claim the money is adding to â&#x20AC;&#x153;reserves.â&#x20AC;? When is the last time you saw your premium go down for insurance of any kind?

The ACA is going back to the Supreme Court in King v. Burwell over whether or not a person who enrolls through a federal exchange is entitled to the same federal subsidy as one who enrolls through a state exchange, even though the law does not provide for it. The defenders of the law say it was a mere oversight, and the legislative intent of the entire law was to provide coverage for everyone. Exhibit A for plaintiff King will be none other than Mr. Gruber, who let the cat out of the bag when he told a group of students that the subsidy was intentionally denied to those enrolling through the federal exchanges to force states to construct their own. Only 13 states did so.

Weâ&#x20AC;&#x2122;ll see how the Supreme Court, and specifically Chief Justice Roberts, reacts to the â&#x20AC;&#x153;law really doesnâ&#x20AC;&#x2122;t matterâ&#x20AC;? crowd this time around. I agreed with him when he denied conservatives victory the first time around over the mandate issue (see â&#x20AC;&#x153;Who Shot J.R.?â&#x20AC;? General Surgery Newss October 2012, page 1). My guess is that he, alarmed by the presidentâ&#x20AC;&#x2122;s apparent lawlessness in the immigration issue, will use this case to make the point that laws matter, theyâ&#x20AC;&#x2122;re not fluid, and they canâ&#x20AC;&#x2122;t be ignored to serve political objectives. He will reject the notion that in a nation held together by the rule of law, breaking the law is permissible, even if one asserts commitment to a perceived higher moral imperative like religion, conscience or social justice. Political expediency wonâ&#x20AC;&#x2122;t make the list.

Those who do not respect existing law will not get a pass for writing one they had no intention of obeying.

It might just be that the price of amnesty will be the ACA.

In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / JANUARY 2015

Colorectal Cancer Rates Are Surging In Younger Patients B Y M ARIE R OSENTHAL PHILADELPHIA A—A growing number of younger patients are being diagnosed with aggressive colorectal cancer, even as the incidence of the disease among older patients is declining, new research shows.

The incidence of early-onset colorectal cancer (CRC) among patients younger than age 50 has been rising at an annual rate of 1.5% per year, compared with an annual decrease of 3.1% among older individuals over the past decade, according to the study. Individuals with early-onset disease tend to have larger tumors that are more likely to metastasize.

“Although the incidence in younger patients is still low compared with colorectal cancers in older populations, the trend is alarming and calls for more investigation and appropriate intervention,” said investigator Xi Emily Zheng, MD, PhD, a fellow in the Department of Healthcare Policy and Research at Weill Cornell Medical College, in New York City.

Dr. Zheng’s group presented its findings at the 2014 annual meeting of the American College of Gastroenterology (abstract 7).

Using the Surveillance, Epidemiology, and End Results database from 2000 to 2011, the researchers compared the incidence and characteristics of CRC among patients younger than age 50 (n=39,787) with those of CRC patients who were older than 50 (n=330,009).

The New York researchers also found that younger CRC patients were more likely to be male (odds ratio, 1.13; 95% confidence interval [CI], 1.11-1.16) and black or Hispanic rather than white. Blacks had a 1.6-fold higher risk for CRC than whites (95% CI, 1.57-1.67) and Hispanics had a 2.1-fold higher risk than whites (95% CI, 2.07-2.21), Dr. Zheng said.

In addition to the trends in cancer incidence, Dr. Zheng and her colleagues also found that the rate of distant disease has increased 3% per year, whereas cases of localized or regional tumors have risen 1%.

This trend, which is being seen in clinical practice, is disturbing, said Al B. Benson III, MD, a professor of medicine and the associate director for clinical investigations at Northwestern University’s Robert H. Lurie Comprehensive Cancer Center, in Chicago. “We are seeing increasing numbers of younger patients, and many are presenting with more advanced disease,” said Dr. Benson, who was not part of the study.

The tumors are more advanced in stage, of higher grade, larger size with more neural invasion compared with CRC in older patients. And they are more likely to metastasize, according to Dr. Zheng.

“The young-onset CRC is more likely

to present with aggressive clinicopathologic characteristics compared with old-onset CRC. And the rising incidence of youngonset CRC stratified by stage shows greatest up-trend for the advanced/distant disease,” Dr Zheng said, postulating that it could be due to the distinct underlying biology of this cancer in younger patients and/or a delay in diagnosis.

“It is not clear why this is happening and whether any of the associated risks for developing colon cancer are an issue,

including diet, exercise, obesity, etc. This will have potential impact on how we screen patients for colorectal cancer and push a research agenda to find out how to identify patients at risk to inform screening strategies,” Dr. Benson added.

Both Dr. Zheng and Dr. Benson said more data are needed before baselinescreening policies can be changed butsaid it would be reasonable to consider colonoscopy in younger black or Hispanic individuals with a family history of CRC.

“Screening colonoscopies and removing polyps starting at a younger age would undoubtedly be helpful if we set aside cost,” Dr. Zheng said. “Our study shows CRC diagnosed between 40 and 50 years of age accounts for more than 50% of young-onset CRC.” However, expanding screening to this population would not be cost-effective for our society, said Dr. Zheng, and risk stratification would be needed to determine which people should be screened earlier.

BRIEF SUMMARY OF PRESCRIBING INFORMATION

ENTEREG® (alvimopan) capsules, for oral use 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.

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.

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.

CONTRAINDICATIONS ENTEREG is contraindicated in patients who have taken therapeutic doses of opioids for more than 7 consecutive days immediately prior to taking ENTEREG. WARNINGS AND PRECAUTIONS 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.

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. 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.

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. 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.

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.

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.

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.

ADVERSE REACTIONS 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.

DRUG INTERACTIONS 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.

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.

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.

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.

USE IN SPECIFIC POPULATIONS 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.

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.

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

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.

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.

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.

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.

ENTEREG and E.A.S.E. are trademarks of Cubist Pharmaceuticals. Any other trademarks are property of their respective owners.

Distributed by: Cubist Pharmaceuticals U.S. Lexington, MA 02421 USA © Cubist Pharmaceuticals. All rights reserved.

October 2014 ENT-0232

39

Experience the ENTEREG EFFECT ENTEREG is indicated to accelerate the time to upper and lower gastrointestinal (GI) recovery following surgeries that include partial bowel resection with primary anastomosis.1

› In clinical trials, ENTEREG added to an accelerated care pathway (ACP) was more effective than an ACP alone1 – ENTEREG improved mean time to GI recovery by 11-32 hours vs. placebo1* – ENTEREG also reduced time to discharge order written by 13-22 hours1,2*

ENTEREG improved mean time to GI recovery by up to 20% compared to placebo1* *Data are from 5 multicenter, randomized, double-blind, placebo-controlled studies in patients undergoing bowel resection and 1 study in patients undergoing radical cystectomy. Patients were administered ENTEREG 12 mg or placebo 30 minutes to 5 hours prior to surgery and twice daily after surgery until discharge or a maximum of 7 days. Patients who received more than 3 doses of an opioid (regardless of route) during the 7 days prior to surgery and patients with complete bowel obstruction or who were scheduled for a total colectomy, colostomy, or ileostomy were excluded.1

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 (eg, 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. 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 for ENTEREG. References: 1. ENTEREG [package insert]. Lexington, MA: Cubist Pharmaceuticals U.S.; 2014.

2. Lee CT, Chang SS, Kamat AM, et al. Eur Urol. 2014; 66(2):265-272.

©2014 Cubist Pharmaceuticals ENTEREG and E.A.S.E. are registered trademarks of Cubist Pharmaceuticals. www.ENTEREG.com ENT-0229 November 2014

Distributed by

JANUARY JANUARY 20152015

REPORT Altrus Direct Thermal Energy A Fundamental Approach to Vessel Sealing The Altrus® system includes a pair of ceramic heaters, each mounted in Faculty a parallel jaw mechanism located in the distal portion of the handpiece.

Gudata Hinika, MD One of the heaters provides a flat Chief of Trauma Surgery jaw surface and the other a crowned California Hospital Medical Center jaw surface. The parallel jaw mechLos Angeles, California anism maintains a parallel relationship between the 2 heaters while Jorge L. Rodriguez, MD, FACS tissue is mechanically compressed General Surgeon between them.

Pasadena Surgical Association Once tissue is compressed Pasadena, Texas between the heaters, each heater is separately supplied with electriEric A. Wiebke, MD, MBA cal energy to increase its temperaChief of Surgical Services ture by a resistive heating element VA Medical Center encased d therein, th i creating ti a thermal th l Hampton, Virginia energy effect that is transferred to the tissue.

Technology at a Glance A sealing function is accomplished by the Altrus ® The ConMed® Altrus® Direct Thermal Tissue Fusion Syssystem by transferring a thermal energy effect to tistem (“the Altrus® system”) controls 3 important variables sue during mechanical compression by the parallel jaw in producing reliable, consistent seals: temperature, presmechanism. sure, and time (Figure 1). By applying direct thermal enerA bladeless cutting function is accomplished in a simigy instead of radio frequency (RF) energy or high frequency lar manner to the sealing function, using a different set of mechanical (ultrasonic) energy, the Altrus® system may energy delivery parameters to provide additional thermal reduce the potential for unintended thermal injury. energy to the tissue.

T

he use of tissue fusion devices has expanded the number of potential techniques available for hemostasis and dissection during laparoscopic and open surgery. These devices have been shown to perform on par (as measured by supraphysiologic burst pressures) with traditional clips or ligatures without leaving foreign objects in the body or the tedium of ligatures.1,2 Despite the success and popularity of tissue fusion, the use of these devices has potential disadvantages, including lateral thermal spread, relatively high disposable bl costs, t and d variable i bl b burstt pressures.3

Supported by

REPORT The Altrus System Versus Radio Frequency and Ultrasonic Sealing

fashion (ie, the RF energy is passed from one jaw to the opposing jaw) to heat tissue between the 2 jaws to create a seal.

With RF energy devices, the heat is generated not at the jaws The Altrus® system directly controls the amount of thermal but within the tissue by resistance to the RF energy flowing energy generated by each of the heaters by sensing the resisbetween the jaws. Typically, tissue impedance or tissue impedtance of each heater, and then using the relatively linear relaance changes are used as a control parameter during the seal tionship between a change in cycle to indirectly measure resistance and temperature to tissue temperature and to “The Altrus® Thermal Tissue Fusion System uses a control the amount of electrihelp adjust for a typical sitvery different energy platform than other vessel sealcal energy provided to each uation where the various tisheater. The resistance of each sues located between the ing technologies. The direct thermal energy platform heater is sensed by measurRF jaws at a given seal locaallows Altrus to control the amount of energy delivered ing the voltage and drive curtion have different impedancto bring the heaters to target temperatures to achieve rent to it, and then calculating es, and thus variable heating the desired clinical effect. This consistent temperature the resistance from these valrates. For example, the walls control produces reliable, consistent seals with miniues. Because each of the 2 of vessels have much lower mal thermal damage. For me, the consistent temperaheaters in the Altrus® system impedance than the surture control provides a level of safety that other vessel is mechanically compressed rounding adipose and consealing technologies cannot offer.” against tissue to be sealed, the nective tissue, resulting in —Eric A. Wiebke, MD, MBA temperature of tissue also is different rates of heating. This measured, indirectly, by each differential heating may result heater. Precise resistance in the device delivering more measurements facilitate the delivery of the optimal amount of energy than is required to seal a vessel, with the excess enerthermal energy needed to produce a seal, while minimizing thergy contributing to thermal spread.4,5 mal spread and seal time.

Ultrasonic energy delivery systems, such as the Harmonic RF energy delivery systems such as LigaSure™ (Covidien ACE® (Johnson & Johnson Corp), Sonicision® (Covidien AG), AG), ENSEAL L® (Ethicon Endo-Surgery) or Gyrus® PK (Gyrus SonoSurg® (Olympus Medical Systems Corp) and ThunderACMI, an Olympus Company) use RF energy in a bipolar beat® (Olympus Medical Systems Corp), use high-frequency mechanical vibrations produced by an electrical energy source coupled to a piezoceramic transducer, typically in a closed-loop control manner. High-frequency mechanical vibrations from the piezoceramic transducer are mechanically coupled via a metallic horn to a jaw mechanism that heats tissue located between the jaws to form a coagulum and create a seal while dividing the tissue. Feedback to control the energy delivered occurs between the energy source and the piezoceramic transducer, hence tissue changes are only indirectly reflected back to the electrical energy source. Using this approach, tissue temperature cannot be measured directly, possibly resulting in the device delivering more energy than is required to seal a vessel, with the excess energy contributing to thermal spread.2,6

Non-mechanical Bladeless Cut Versus Mechanical Blade Cut

Figure 1. Altrus® Thermal Tissue Fusion System handpiece and console.

2

The Altrus® system uses a non-mechanical bladeless cutting function to divide tissue. The Altrus® system divides tissue using a combination of thermal energy and mechanical compression by the parallel jaw mechanism. By incorporating a non-mechanical, bladeless cutting function, the Altrus® system allows for multiple cutting activations without concern for blade dulling, thus eliminating the need for another instrument.

Furthermore, the Altrus® system eliminates jamming caused by tissue captured in the cutting mechanism. The Altrus® system also provides an ability to cut rapidly through avascular tissue planes (ie, mesentery) because its cutting function simultaneously seals small vessels. To prevent tissue from sticking to the heaters, each heater has a non-stick PTFE coating that allows tissue to fall away after a seal or cut activation. This feature is unique to Altrus®, as a PTFE coating would act as an insulator in radio frequency–based platforms.

REPORT

Burst Pressure Comparison 360 mm Hg

Clipa (n=16) Harmonic ACE®b (n=60) LigaSure™ Lapb (n=31) LigaSure Atlas™b (n=42) Altrus® 10 mmb (n=48) Altrus® 5 mmb (n=35) 0

500

1,000

1,500 mm Hg

2,000

2,500

3,000

Figure 2. Burst pressure data. a

Mean burst pressure of porcine arteries ranged from 2 to 7 mm.

b

Data collected on in vivo porcine arteries; vessel sizes ranged from 2 to 7 mm.

Based on reference 2.

Comparative Testing Studies

Burst-Pressure Test Method

Two comparative studies were performed to evaluate burst pressure and lateral thermal spread, respectively.7,8 These studies compared the Altrus® system with other vessel sealing devices on the market.

Acute in vivo burst pressure testing was performed using a porcine model because the vascular tissue is similar to human vascular tissue. In vivo seals were performed on saphenous, gastroepiploic, splenic, and colonic artery bundles (may include some fat, connective tissue, vein or a nerve) ranging in size from 1 to 12 mm.

Comparative Testing: To evaluate seal perforBurst Pressure mance, arterial burst pres“Altrus® has allowed me to reduce my OR time for Performance sure testing was performed. most of my surgical procedures. Not only are the Burst pressure testing was Burst pressure testing consistactivation cycles very rapid, but Altrus® produces performed to compare the ed of cannulating the sealed a very reliable, consistent seal. The unique bladeAltrus® system with other vesvessel segment and placing sel sealing systems and tradithe sample in a tray of water. less cutting mechanism allows me to cut through tional mechanical ligating via Then, air was injected into avascular tissue while still providing hemostasis to clips as the gold standard.7 the vessel segment using a smaller vessels.” syringe pump at a rate of 50 cc —Jorge L. Rodriguez, MD The systems tested included: per minute. During testing, ves• The Altrus® system, including sel pressure was monitored by the Altrus® Energy Source, the Altrus® 5 mm and the Altrus® a pressure transducer/data acquisition system in parallel to the 10 mm handpieces sealed vessel and recorded on a laptop computer. The pres® • The LigaSure system, including the ForceTriad™ electrosure was increased until the seal burst, which was indicated by surgical generator, the LigaSure Atlas™ handpiece, and the air bubbles and a sharp decline in the recorded pressure trace, LigaSure™ Lap (LigaSure™, ForceTriad™, and LigaSure with the burst pressure being the maximum pressure recorded.

Atlas® are registered trademarks of Covidien AG); Burst Pressure Test Results • The Harmonic ® system, including the Harmonic ACE ® handpiece and the UltraCision ® Harmonic ® Scalpel GenIn vivo burst pressure data are shown in Figure 2.7 The ® ® ® erator 300 (Harmonic , ACE , and UltraCision are regis360 mm Hg line in the figure represents 3 times a normal systoltered trademarks of Johnson and Johnson Corp.) ic pressure of 120 mm Hg. Because burst pressure values are • Titanium Laparoscopic Clips, burst pressure data were representative of the porcine model, it should be understood obtained directly from K.L. Harold and colleagues.2 that individual values seen in the human model might vary.

3

REPORT Burst Pressure Conclusion

• The Altrus ® system 5 mm handpiece (quantity [Qty], 3); Burst pressures measured during this study showed that the • The LigaSure™ Lap handpiece (Qty, 1); and ® ® Altrus 5 mm, the Altrus 10 mm, and clip produced seals with• The Harmonic ACE® (Qty, 3). standing 3 times the normal systolic pressure (360 mm Hg). In Arteries also were sealed using 2, 10 mm devices: addition, of the energy-based devices, the Altrus® 5 mm and • The Altrus ® system 10 mm handpiece (Qty, 3); and the Altrus® 10 mm handpieces had the lowest range of burst • The LigaSure Atlas™ handpiece (Qty, 3). pressures, which shows consistency.

Each of the Harmonic ACE® handpieces was tested using a Generator 300 electrosurgical generator. The Generator Comparative Testing: Single Activation 300 includes 2 power settings, minimum and maximum, with each handpiece having sepaThermal Spread rate buttons to activate each set“I have had the opportunity to use many There is evidence in the literating. Upon startup, the Generator energy-based vessel sealing technologies.

300 sets the minimum power setture that electrosurgery may lead With Altrus, one of the first things I noticed ting to a value of 3 (out of 5) and to inadvertent damage of nearby 9,10 was the quality of the seal it produced. With structures, such as nerves, intesthe maximum power setting to a value of 5 (out of 5). Furthermore, tine, ureter, and bile ducts. Clinicians other technologies, I found myself needing relevant testing in the literature have reiterated that thermal spread to perform double or even triple seal activadamage also may result in delayed was performed using a power tions to get the desired clinical effect. The 10 setting of 3 (out of 5).2,9,15,18,19 The injuries to surrounding tissue that consistent, high-quality seal I get with Altrus startup minimum power setting of may not be macroscopically apparhas allowed me to be more efficient in my 3 was used for all of the testing ent at the time of surgery.11 Specifprocedures.” described here. ically, Harold and colleagues noted —Gudata Hinika, MD For each of the following tests, that the importance of quantifying LigaSure™ handpieces were testthe thermal spread of tissue fusion ed using a ForceTriad™ electrosurgical generator. The Forcedevices to prevent injury to structures cannot be overstated.2 Triad™ includes a single power setting, with each handpiece With handpieces from the Altrus® and LigaSure™ systems, there is potential for thermal damage, primarily in the form of lathaving a single button to activate the device. Upon startup, the eral thermal spread. However, it should be noted that ultrasonic ForceTriad™ sets the power to a value of 1 (out of 3). Relevant testing in the literature was performed using a power setting of devices, such as the Harmonic ACE® can have thermal damage in addition to transmural injury induced by mechanical means.12 2; accordingly, each of the relevant tests described here also Variability exists in the literature regarding the extent of laterused a power setting of 2.2,18 Both Altrus® handpieces and the 2 LigaSure™ handpieces al thermal spread damage measured for different tissue fusion 1,2,13-18 were activated 30 times to perform a seal function on saphedevices.

This variability likely is the result of different experimental methods. The most common method is to perform hisnous, splenic, gastroepiploic, and colonic arteries. Each of the topathologic measurements on hematoxylin and eosin (H&E) Altrus® system 5 mm and Harmonic ACE® handpieces were 1,13-15,18 stained tissue sections. activated 30 times to perform seal and cut functions (seal/cut) An additional method of measuring thermal spread is by visual on saphenous, splenic, gastroepiploic, and colonic arteries. assessment of the blanched tissue.18 Visual thermal spread meaAfter each seal or seal/cut, the visual thermal spread (ie, the surements are not meant to replace histology measurements or largest width of visually blanched tissue from the edge of the be a representation of those measurements. Although thermal seal) was measured with a calibrated metric ruler. After visuspread can be measured more precisely with histologic samples, al measurement, the artery was harvested and the sample was a visual measurement based on the width of blanched tissue durplaced in a labeled tissue cassette and stored in a 10% neutral ing surgery provides immediate feedback to assess the potential buffered formalin solution. On the tissue cassette, each tissue for thermal injury and inadvertent damage to nearby structures. sample was given a unique letter and number designation to This comparative test had 4 objectives: blind the pathologist to the device model during measurements.

• Perform a thermal spread study of histologic and visual therHistopathologist Method mal spread measurements for 5 tissue fusion devices.

• Compare the thermal spread of 5 tissue fusion devices to Artery samples were sent to an independent histology lab, one another.

Premier Laboratory, LLC, Boulder, Colorado, for processing, • Compare thermal spread measurements between visual and thermal spread was measured by an independent pathol(surgeon visualization) and histologic thermal spread meaogist. The histology lab processed all samples to paraffin, secsurements (damage to cells). tioned longitudinally, and stained the samples with H&E. Four • Compare thermal spread measurements with values reportmeasurements (to 0.1 mm) were made using an ocular reticle ed in the literature. for each sample, 2 on each side of the thermal seal, from the edge of the seal to the farthest extent of thermal damage for Methods both the tunica (T.) adventitia and the T. media.

In-Vivo Experimental Procedure Statistical Analysis Five female pigs weighing about 48 kg were placed under general anesthesia to undergo an open procedure.8 Arteries Visual and histologic thermal spread data were analyzed were sealed alternately using 3, 5 mm tissue fusion devices: separately. For each method, thermal spread data were

4

REPORT

A

Visual and Thermal Spread of 5 mm Device 5

P=0

P=0.275

P=0

P=0

3

2

9

9

9

2.3 2.5

2.5

2

1.9

1.8

9

9

1.3

9

9

9

Thermal Spread, mm

4

1.5

1

Visual

Histology

Altrus Seal

®

B

Visual

Histology

LigaSure™ Lap Seal

Visual

Histology ®

Visual

Histology

Harmonic ACE ® Seal/Cut

Altrus Seal/Cut

Visual and Thermal Spread of 10 mm Device 4.0

P=0.515

P=0.495

9

9

3

2

9

2.5

9

Thermal Spread, mm

3.5

1.5

1

Visual

Histology Altrus Seal

®

Visual

Histology

LigaSure™ Lap Seal

Figure 3. Visual vs T. adventitia histology thermal spread box plots for (A) 5 mm and (B) 10 mm devices.

5

REPORT grouped by handpiece, with arteries grouped and examined together. Statistical comparisons were performed using a 2-sample t-test with a significance level of P≤0.05. The Altrus ® 5 mm seal activation was compared with the LigaSure™ Lap, the Altrus ® 10 mm seal activation was compared with the LigaSure Atlas™, and the Altrus ® 5 mm seal/cut was compared with the Harmonic ACE®.

Device Comparison Visual and histologic thermal spread measurements from 5 tissue fusion devices (mixture of 5 mm and 10 mm handpieces from

different manufacturers detailed above) were obtained and are presented in Figure 3. Figure 4 shows an example seal for Altrus® (Figure 4A) and LigaSure™ Atlas (Figure 4B) and a seal/cut for the Harmonic ACE® (Figure 4C). In addition, Figure 4A illustrates the location of the T. adventitia and T. media layers in an artery.

Histologic thermal spread was greater in the T. adventitia than the T. media. According to the pathologist, “thermal damage to the T. media was variable and sometimes difficult to measure.”

Because the T. media was difficult to measure and is much less than the T. adventitia, only the worst-case thermal spread (T. adventitia) is presented in this report.

Visual Thermal Spread Data Analysis Visual thermal spread measurements consist of a score (1-4) that relates to a measurement in millimeters (thermal spread 0-1 mm results in a score of 1; 1-2 mm is a score of 2). For these data, each score was assumed to have the worst-case thermal spread measurement. For example, a score of 1 would result in a measurement of 1 mm for data analysis.

Device Comparisons for Each Thermal Spread Measurement Method

A

Three statistical comparisons (Altrus ® 5 mm seal activation vs LigaSure™ Lap, Altrus® 10 mm seal activation vs LigaSure™ Atlas, Altrus ® 5 mm seal/cut activation vs Harmonic ACE® ) were performed for each method and tissue type (visual and T. adventitia histologic). Comparisons included handpiece size (5 or 10 mm) and activation type (seal or seal/cut).

Visual Thermal Spread Visual thermal spread measurement box plots for each device are shown in Figure 3. For each comparison, the Altrus® handpieces had a significantly lower mean visual thermal spread. Altrus® 5 mm seal/cut compared with the Harmonic ACE® resulted in the smallest difference in visual thermal spread measurements. Mean visual thermal spread was not significantly different between the Altrus® 5 mm seal (1.5 mm) and Altrus ® 5 mm seal/cut (1.3 mm) activations.

Histologic Thermal Spread – T. Adventitia B

T. adventitia thermal spread measurement box plots for each device are shown in Figure 3. For each comparison, the Altrus® handpieces has a significantly lower mean thermal spread.

Mean T. adventitia thermal spread was similar between Altrus® 5 mm activation types (seal = 2 mm vs seal/cut = 1.9 mm) as well as between handpiece size (5 mm = 2 mm vs 10 mm = 2 mm). Both 5 and 10 mm Altrus® handpieces resulted in a lower mean T. adventitia thermal spread than LigaSure™ Lap, LigaSure Atlas™, and Harmonic ACE®.

C

Visual Versus Histologic Comparison

Figure 4. Histology samples stained with H&E: (a) Altrus®, (b) LigaSure™, Atlas™, (c) Harmonic ACE®.

H&E, hematoxylin and eosin

6

Two thermal spread measurement methods (visual and histologic) were used to make the same measurement. Each method measured from the edge of the seal to the farthest extent of thermal damage.

Visual thermal spread measurements assess the amount of visually blanched surface tissue. This corresponds to the T. adventitia layer of the blood vessel. Therefore, this section focuses on comparing visual with T. adventitia histologic measurements.

REPORT Individual visual thermal spread data points underestimate the histologic thermal spread. This outcome was anticipated and is appropriate because staining and a microscope can detect more thermal damage than the naked eye.

Figure 3 shows visual and histologic thermal spread box plots for each device. Significant differences in visual and histologic measurements were found in half of the comparisons (Altrus ® 5 mm seal, Altrus ® 5 mm seal/cut, and Harmonic ACE® ). For these comparisons, the visual thermal spread mean was significantly different and lower. For the LigaSure™ Lap, LigaSure Atlas™ and Altrus ® 10 mm, no significant difference between thermal spread measurements was found. Therefore, a correlation between visual and T. adventitia histologic measurements was not found.

Statistical Significance Statistical comparisons were made (Altrus ® 5 mm seal activation vs LigaSure ® Lap, Altrus ® 10 mm seal activation vs LigaSure™ Atlas, Altrus ® 5 mm seal/cut activation vs Harmonic ACE ® ) for the 2 thermal spread measurements, visual and histologic T. adventitia. Statistical significance was determined with a 2-sample t-test where P≤0.05

was considered statistically significant. For both thermal spread measurement methods, the Altrus® 5 mm seal activation mean thermal spread was signficantly lower than the LigaSure™ Lap; the Altrus ® 10 mm seal activation mean thermal spread was significantly lower than the LigaSure™ Atlas; and the Altrus ® 5 mm seal/cut activation mean thermal spread was significantly lower than the Harmonic ACE®.

Literature Comparison A comparison of the results from this study showed that the Altrus ® 5 mm, Altrus ® 10 mm and the LigaSure™ Lap had thermal spread values within the range reported in the literature for histologic measurements (Table). The majority (87%) of the Harmonic ACE® histologic thermal spread data is within the range reported in the literature. Four samples were greater than 3.3 mm. However, the LigaSure Atlas™ histologic thermal spread range was above the range reported in the literature.14

Limitations This study had some limitations. First, each seal or seal/cut was produced by a single activation and each device started at room temperature. Tissue fusion devices heat up with

Table. Arterial Thermal Spread: Histopathology Results Compared With the Literature Histologic Thermal Spread Comparison Device

Thermal Spread Range, mm

Reference

Altrus ® 5 mm (seal) a

M: 0-0.2; A: 1.2-3.2

–

LigaSure™ Lapa

M: 0-0.6; A: 1.7-3.9

–

LigaSure™ V

0-5.2

1,13-15,18

Altrus ® 10 mma

M: 0-0.2; A: 1.4-2.7

LigaSure Atlas™ a

M: 0.1-0.3; A: 2.0-3.9

LigaSure Atlas™

0.5-2.8

14

Altrus ® 5 mm (seal/cut) a

M: 0-0.5; A: 1.3-3.5

–

Harmonic ACE ®a

M: 0-0.3; A: 1.5-4.6

–

Harmonic ACE ®

0.1-3.3

14,15

THUNDERBEAT T®

A: 1.5-3.6

18

Visual Thermal Spread Comparison Altrus ® 5 mm (seal) a,b

1.5±0.5

–

LigaSure™ V b

1.7±0.6

18

Altrus ® 5 mm (seal/cut) a,b

1.3±0.5

–

Harmonic ACE ®b

1.5±0.6

18

a

Data from this study Mean ± standard deviation A, T. adventitia; M, T. media b

7

REPORT sequential activations, which can result in increased thermal spread. Second, this was an open procedure instead of laparoscopic. According to Song and colleagues, thermal spread damage tends to be higher in laparoscopic surgery.20 Finally, only 1 LigaSure™ Lap handpiece was available for this study.

Thermal Spread Assessment This study showed that Altrus ® 5 mm (seal) and Altrus ® 10 mm had significantly lower mean visual and T. adventitia histologic thermal spread than LigaSure™ Lap and LigaSure Atlas™, respectively. The Altrus ® 5 mm (seal/cut) had significantly lower mean visual and T. adventitia histologic thermal spread than the Harmonic ACE® handpieces.

In general, visual thermal spread measurements provide equivalent or lower values than histologic thermal spread measurements, which is to be expected because thermal tissue damage cannot be visually detected with the same precision as histologic measurements. No correlation between visual and histologic thermal spread data could be drawn.

However, data analysis with each method resulted in the same statistical conclusions.

Conclusion The ConMed® Altrus® Thermal Tissue Fusion System uses direct thermal energy to seal or cut tissue in open and laparoscopic procedures. Optimal and controlled direct thermal energy is delivered to the tissue using 2 ceramic heaters. By directly controlling the thermal energy, mechanical pressure delivered to the tissue and time, the Altrus® system produces consistent and reliable seals (as measured by supraphysiologic burst pressures, [Figure 2]).

Tissue fusion devices have the potential to produce unintentional thermal injury through lateral thermal spread. This report evaluated the Altrus® system for lateral thermal spread, and the Altrus® system was found to produce significantly less thermal spread than comparable devices: the LigaSure™ Lap, LigaSure Atlas™, and Harmonic ACE®. Furthermore, the thermal spread values presented in this report for the comparative devices are similar to data published in the literature.1,3,8-12,15 Additionally, the Altrus® system provides a non-stick thermal energy bladeless cut that can seal small vessels simultaneously. This thermal cut can be used for cutting vessels and rapid activations through avascular tissue.

References

3. Lamberton GR, Hsi RS, Jin DH, et al. Prospective comparison of four laparoscopic vessel ligation devices. J Endourol.

2008;22(10):2307-2312.

4. Munro M. Fundamentals of Electrosurgery Part 1: Principles of Radiofrequency Energy for Surgery. The SAGES Manual on the Fundamental Use of Surgical Energy (FUSE). 2012:15-59.

5. ForceTriad® Energy Platform User’s Guide, Rev 12/2009.

6. Davison T, Amaral J, Geis P, et al. The science of ultrasonic energy-based dissection. General Surgery News. 2008.

7. 510k Testing for ConMed Altrus Thermal Tissue Fusion System, Tab R or K101534. November 24, 2010.

8. ConMed Corp. Thermal Spread Study: Visual and Histologic Measurement; May 2013. Data on file.

9. Kim F, Chammas M, Gewehr E, et al. Temperature safety profile of laparoscopic devices: Harmonic ace (ace), ligasure v (lv), and plasma trisector (pt). Surg Endosc. 2008;22(6):1464-1469.

10. Sutton PA, Awad S, Perkins AC, et al. Comparison of lateral thermal spread using monopolar and bipolar diathermy, the harmonic scalpel and the ligasure. Br J Surg. 2010;97(3):428-433.

11. Emam TA, Cuschieri A. How safe is high-power ultrasonic dissection? Ann Surg. 2003;237(2):186-191.

13. Carbonell AM, Joels CS, Kercher KW, et al. A comparison of laparoscopic bipolar vessel sealing devices in the hemostasis of small-, medium-, and large-sized arteries. J Laparoendosc Adv Surg Tech A. 2003;13(6):377-380.

14. Person B, Vivas DA, Ruiz D, et al. Comparison of four energybased vascular sealing and cutting instruments: a porcine model.

Surg Endosc. 2008;22(2):534-538.

15. Phillips CK, Hruby GW, Durak E, et al. Tissue response to surgical energy devices. Urology. 2008;71(4):744-748.

16. Richter S, Kollmar O, Neunhoeffer E, et al. Differential response of arteries and veins to bipolar vessel sealing: evaluation of a novel reusable device. J Laparoendosc Adv Surg Tech A. 2006;16(2):149-155.

17. Santini M, Vicidomini G, Baldi A, et al. Use of an electrothermal bipolar tissue sealing system in lung surgery. Eur J Cardiothorac Surg. 2006;29(2):226-230.

18. Milsom J, Trencheva K, Monette S, et al. Evaluation of the safety, efficacy, and versatility of a new surgical energy device (THUNDERBEAT) in comparison with Harmonic ACE, LigaSure V, and EnSeal devices in a porcine model. J Laparoendosc Adv Surg Tech A. 2012;22(4):378-386.

19. Hruby GW, Marruffo FC, Durak E, et al. Evaluation of surgical energy devices for vessel sealing and peripheral energy spread in a porcine model. J Urol. 2007;178(6):2689-2693.

20. Song C, Tang B, Campbell PA, et al. Thermal spread and heat absorbance differences between open and laparoscopic surgeries during energized dissections by electrosurgical instruments. Surg Endosc. 2009;23(11):2480-2487.

Disclosures: Drs. Hinika, Rodriguez, and Wiebke have nothing to disclose.

Disclaimer: This monograph is designed to be a summary of information. While it is detailed, it is not an exhaustive clinical review. McMahon Publishing, CONMED, and the authors neither affirm nor deny the accuracy of the information contained herein. No liability will be assumed for the use of this monograph, and the absence of typographical errors is not guaranteed. Readers are strongly urged to consult any relevant primary literature.

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Copyright © 2015, McMahon Publishing, 545 West 45th Street, New York, NY 10036. Printed in the USA. All rights reserved, including the right of reproduction, in whole or in part, in any form.

MCM2014248

2. Harold KL, Pollinger H, Matthews BD, et al. Comparison of ultrasonic energy, bipolar thermal energy, and vascular clips for the hemostasis of small-, medium-, and large-sized arteries. Surg Endosc. 2003;17(8):1228-1230.

12. Kadesky KM, Schopf B, Magee JF, et al. Proximity injury by the ultrasonically activated scalpel during dissection. J Pediatr Surg.

1997;32(6):878-879.

SR1411

1. Landman J, Kerbl K, Rehman J, et al. Evaluation of a vessel sealing system, bipolar electrosurgery, harmonic scalpel, titanium clips, endoscopic gastrointestinal anastomosis vascular staples and sutures for arterial and venous ligation in a porcine model. J Urol.

2003;169(2):697-700.