February 2014

CONVENTION ISSUE:

Americas Hernia Society

GENERALSURGERYNEWS.COM

February 2014 • Volume 41 • Number 2

The Independent Monthly Newspaper for the General Surgeon

Opinion

Elevate Us

Bariatric Surgery May Stunt Aging Mechani

B Y L AUREN K OSINSKI , MD

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n my residency, gravity rounds started on the highest floor where we had patients and dropped down a floor at a time until we finished in the basement cafeteria. We uniformly dreaded 8th floor consultation, but especially when our chairman, William Blaisdell, was attending. A venerable old-school surgeon who operated at a Civil War surgery pace and seemed to subsist on air alone, he must have been in his early 70s when I started my internship. He led us on an asphyxiating twostairs-at-a-time sprint up the stairwell.

Difficult enough in scrubs and flat shoes, it was a killer in heels donned on clinic days. We struggled to present our patients in full sentences at the top of the climb, showing no signs of weakness.

As an intern, I regarded this as primarily a macho exercise. Now, after many more years in the hospital, I realize how a surgeon’s long hours make it difficult to get regular exercise. Now the stairs provide a regular, on-the-job opportunity to build stamina. My rule of thumb is to alwayss walk if my destination is up one flight or down two flights, and I see ELEVATE page 16

ISSUES FOR THE BARIATRIC & METABOLIC PROFESSIONAL

Extended Quarterly Coverage Section begins on page 8

B Y C HRISTINA F RANGOU ANGOU

Opinion

Surgeons’ Lounge

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In the News FMT Stands up to Antibiotics in Cost Model

is part fact, part observation and part editorial.]

The mere mention of roboticassisted surgery evokes strong passions. “Love” and “hate” are words heard when discussions turn toward the robot in the operating room.

Logic becomes murky as the debate

W ASHIINGTON —Newer-generation permanent synthetic meshes weree associated with significantly reduced short-term frequencies of surgical sitee occurrences and hernia recurrences compared with biologic meshes for open ventral hernia repairs in clean-contaminated and contaminated surgical sites, according to research presented at the 2013 Clinical Congress of the American College of Surgeons.

The report comes from the first prospective, observational cohort study comparing the effectiveness of permanent synthetic mesh and biologic mesh reinforcement in these difficult cases.

The authors, who are experts in hernia repair, stress that the study is observational: Cases were not matched and follow-up was considerably shorter in the synthetic mesh group. But the results support those from other studies that demonstrate the safety and effectiveness of synthetic mesh in clean-contaminated and contaminated surgical sites ((J Am Coll Surg 2013;217:991998; Trials 2012;13:226; World J Surg 2010;34:1637-1640).

“These observational data indicate that

see ROBOTIC SURGERY page 4

see SYNTHETIC MESH page 13

Telomeres are highlighted in red in image of chromosomes (top) (top).

Source: NASA

the findings at the first annual joint meeting of the American Society for Metabolic and Bariatric Surgery and see TELOMERES page 12

B Y G ARY H. H OFFMAN , MD, E IMAN F IROOZMAND , MD, L IZA M. C APIENDO , MD, S TEPHEN Y OO , MD, A LLEN K AMRAVA , MD

INSIDE Physicians’ Pay and Patient ”Happiness”

B Y C HRISTINA F RANGOU

The Robot: A Tool? A Toy? An Advance? [[A caveatt: This is an overview of a relatively new technology and a new surgical endeavor. r It is not an exhaustive review and it is not meant as a substitute for a scientific evaluation.

It is a practical look at a new surgical world. d Most importantly, what follows is an attempt to raise many questions and provide a few answers. The article

A pregnant woman with frank ischemia and loss of motor and sensory functions of lower extremity

Potenti Seen For Potential Synthettic Mesh In Con ntaminated Surrgical Sites Obbservational Data, Short on Follow-Up; An ‘Excellent Start’ A

B

ariatric surgery may reverse the shrinkkage of telomeres, the caps on the ends of each strand of DNA that are considered markers for biological aging, according to a small, preliminary stud dy presented at Obesity Week.

“This is the first study t d tto demonstrate that surgical weight loss leads to decreased aging by increasing telomere length,” said lead author John M. Morton, MD, MPH, director of bariatric surgery, Stanford University in Stanford, Calif.

He and his colleagues presented

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GSN Editorial

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / FEBRUARY 2014

A Flawed Process: Physician Reimbursement Linked to Patient Happiness Frederick L. Greene, MD, FACS Clinical Professor of Surgery UNC School of Medicine Chapel Hill, North Carolina

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atient satisfaction and scoring techniques have served as editorial fodder for me in the past (“Patient Satisfaction Scores—A Black Box,” December 2010, page 3). In the editorial, I spoke about the measurement of patient satisfaction and the opportunities for dissatisfaction that have nothing to do with the way a patient views his or her own physician. In my view, we face an even greater dilemma today as patient satisfaction scores are being linked with greater frequency to physician and hospital reimbursement.

Those of you who work in hospitals have, no doubt, become aware that patient satisfaction scores are being tied to financial incentives for physicians. In my opinion, this is fraught with danger and can lead to unintended negative consequences. We all know about these potentially flawed scoring strategies introduced by groups such as Press Ganey that mirror

satisfaction metrics in other sectors such as restaurants, hotels and car dealerships.

We all want our patients to appreciate us and be happy with our care. The issue is whether there are potential conflicts in a system in which physicians and hospitals are monetarily incentivized to have “happy patients.” To what ends would the provider and the medical establishment go to assure patients are “happy”?

Often, happiness is a result of patients receiving the care they demand, and not what is medically justified. We have all experienced patients who demand certain drugs, imaging studies, surgical procedures and home care strategies that may be unwarranted, unhelpful or downright wrong! Some of us have even acquiesced to those demands to avoid confrontation with patients or their families. If monetary gain is now inserted into this dialogue, what might be the consequences on medical decision making? In my opinion, the downside is more detrimental than any conflict caused by associations with drug companies or device makers!

Relying on patient satisfaction scores is a very dangerous concept because physicians could easily give in to patient

demands such as antibiotics for a viral illness; heavy narcotics or a computed tomography scan for minor trauma; or anything else that might make them happy. Obviously, many of us have used our best medical judgment to refrain from offering unwarranted treatments only to engender the displeasure of patients who have different thoughts regarding their care. What would happen as we encounter these conflicts with the knowledge that we will be reimbursed because of the “happiness factor” of our patients? Would we give in to the desires of patients just to increase our Press Ganey scores?

In a study published in 2012 (Arch ( Intern Medd 172:405-411), researchers reported data from approximately 52,000 patients who responded to a national Medical Expenditure Panel Survey during the period from 2000 to 2007.

The results showed that the most satisfied patients used more in-patient hospital days and had higher prescription drug expenditures. I could not determine whether these expenditures were necessary or conformed to best practices. The results may indicate that many physicians would consent to the patient’s desires if

they were accountable to patient satisfaction scores for their payment.

This is an entirely flawed concept. Physician reimbursement by either the hospital or federal programs such as Medicare and Medicaid should not be predicated on patient satisfaction scoring. There is no question that the concept of patient satisfaction represented by Press Ganey scores has become the holy grail of many hospital administrators. If we are creating a system in which patient satisfaction is a primary driving force in health care economy, the entire system will suffer.

Unfortunately, many patients have unrealistic expectations that can never be satisfied by even the most compassionate physician. The health care system should reward physicians and hospitals according to established quality benchmarks.

The only winners in this game of linking pay to patient satisfaction are the entities created to measure and promulgate these highly suspect data. The time has come for our professional organizations and us to take a stand against these flawed strategies. A reasonable payment system must be based on quality outcomes of our patients and not their levels of happiness.

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Opinion ROBOTIC SURGERY jcontinued from page 1

rages. But one thing is clear: The technology works. And not only does it work, it works beautifully in every sense of the word. The surgical robot represents the intersection of science and art; a surgeoncontrolled machine directed toward delicate human dissection. Talk about “no touch” technique. This is it. To watch one robotic operation, guided by a skilled surgeon, is to see surgery at its finest; to see it as we picture it. The technology works.

So what? To ask whether the technology works, or whether we should allot dollars to robotic surgery, is to ask important questions. However, these may not be the bigger, more important questions. Let’s look first at surgical history, and at the smaller questions.

Confusion and Fear If you are a “traditional” surgeon (insert your own age here), then you may feel somewhat antiquated in the present-day, high-tech operating room. Fast forward.

It gets worse. You are about to feel like a dinosaur. Stand in an operating room with an operating robot docked comfortably at the side of the patient who is lying on the operating table. Watch as the surgeon, dressed in a traditional sterile surgical gown and gloves, places several instruments and readies the operative field. So far, so good. But just as you are beginning to feel comfortable in this new world, beginning to think that you are not really the ghost of the operating room past, and that you might actually fit in here, the surgeon abruptly turns, walks away, removes the sterile gown, snaps off the gloves and sits down at a console in the corner. Before you blurt out “Where are you going?” you realize that you have just stepped far out of your comfort zone and through the door marked “tomorrow,” today. If you are a “young” surgeon (insert your own age here), this new world is the same old world of your present-day operating room. The transition likely will be but a small blip on your lifetime learning curve. But, if you are that “traditional” surgeon, you are going to begin to ask yourself a lot of questions. The answers to these questions may bother you or elate you. The answers are as much about your mind as they are about the operating room. The answers are about more than the date on your residency certificate or the date on your maintenance of certification certificate. You are about to find out if you are “traditional” or “young.” Perhaps you are both.

And should you become concerned that you, the surgeon, are about to become expendable, take heart. With all of the automation in our modern aircraft cockpits, two pilots guide and control the plane. Two pilots make sure that each of

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / FEBRUARY 2014

us arrives safely at our destination. The pilot, not the robot, is responsible for our safety. As with aircraft avionics, the surgical robot works for us. You are not expendable … yet.

How Did We Arrive at the Present?

Or Is This the Future?

The confined space of the human pelvis can hamper visibility and maneuverability in the operative field. Both laparoscopic and robotic systems are touted as helping the surgeon overcome this space limitation. This has spurred the explosive growth of minimally invasive technologies.

Robotic surgery was originally developed by the military for remote surgical use. Subsequently, its use was found to be more applicable as an on-site tool. The first robotic procedure, a prostate operation, was performed in 1992. To date, more than 1.5 million robotic procedures have been performed worldwide.

In 2000, the FDA approved the da Vinci robotic system for use in intraabdominal surgery. The initial popularity of robotic systems was for use in urologic and gynecologic procedures.

Robotic colorectal surgery was first performed in 2001. Only six reported robotic colectomies were performed between December 2001 and April 2002 despite literature demonstrating the feasibility and safety of the da Vinci system.

Fifty-three robotic colorectal procedures were performed between 2001 and 2003, with 22 of these cases being for malignancy. The general consensus was that robotic techniques could achieve the same operative and postoperative results when compared with conventional laparoscopic techniques. According to one review, the use of robotic surgery in colorectal operations increased by 100% from 1,188 cases in 2009 to 2,380 cases in 2010. In contrast, the use of laparoscopy increased only by 1.15%.

Colorectal surgeons were thoughtfully slow to adopt robotic technology.

Questions arose as to what, if any, were the advantages of robot-assisted colorectal surgery. In contradistinction to the improved, hand-sewn, robot-guided urethral anastomosis, the stapled colorectal anastomosis performed during robotassisted surgery was no different than the stapled anastomosis performed during laparoscopic procedures. And then,

there was the issue of cost. New systems were expensive to purchase or lease, and to maintain, to say nothing of the cost of the disposable items for each case. And, what about the steep learning curve?

With the inevitable development of new equipment and experience, coupled with a never-ending drive to advance in fertile directions, surgeons and industry have begun to look again at robotic technology.

Costs have come down and instruments are being made to better fit the needs of the colorectal surgeon and the general surgeon, as well as various other surgical specialists. The surgical community has begun to re-evaluate robotic-assisted technology and operative strategies. Does the improved experience in urologic surgery translate to colorectal surgery? To other specialties? Specifically, in colorectal surgery, current robotic techniques are focused on the treatments of rectal cancer, rectal prolapse, enterocele repair and diverticulitis.

Similarities Between Laparoscopic and Robotic Systems As in laparoscopic surgery, robotic surgery makes use of small incisions. In both techniques, patients recover faster compared with recovery times following open operations. With a more rapid recovery, needed chemotherapy can begin sooner when laparoscopic or robotic surgery is used for rectal cancer. In surgery for very low rectal tumors, the increased visibility using modern optic systems and improved precision and access to the most distal surgical sites—allowing for increased rates of sphincter-sparing procedures—could potentially decrease the permanent ostomy rate. Additionally, postoperative pain is minimized by an extraction site incision of just 6 to 8 cm (and in some cases even shorter) compared with an incision length of 15 to 20 cm in open surgery. Large, comparative clinical trials are under way, and results thus far indicate that robotic surgery is as effective as open surgery, and yields results “no worse” than the results in laparoscopic surgical procedures.

The (Advertised) Bells and Whistles of Robots

The da Vinci Surgical System by Intuitive Surgical.

The robotic system has certain benefits for both the surgeon and the patient.

These are: Three-dimensional high-definition vision. The robotic system has two high-definition cameras that provide the surgeon with a magnified, stereoscopic view of the surgical site, combining accurate depth perception with a sharp image.

An additional arm. This additional arm, which can be used to hold a retractor or other surgical instruments, gives the

Opinion

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / FEBRUARY 2014

surgeon 50% more operating capability.

Instant image referencing (“TilePro”). This feature allows the surgeon to display up to two diagnostic ultrasound or computed tomographic (CT) images taken before surgery, inside the da Vinci console monitor, directly alongside the view of the realtime procedure, providing a critical extra reference when necessary.

Extra-mobile “wrist action.” The mechanical wrists, which can hold a wide array of specialized instruments, function just like a human wrist, but with even greater range of motion. This facilitates a relative ease of intracorporeal suturing.

Scalability and dexterity. This innovation allows the surgeon to calibrate the robot’s arm to move a fraction of an inch for every inch that the surgeon’s hand moves, simplifying the most complex movements, including delicate resections, suturing and knot-tying. With the robotic system, movements are smooth and without awkwardness. Natural tremor is eliminated.

Anastomotic vascular perfusion. Following the injection of indocyanine green, vascularized tissues are seen as green under fluorescent light, whereas underperfused or nonperfused tissues are seen as grey or black. (Presently, it is not known whether this technology is predictive of the anastomotic leak rate and more study is needed to evaluate this technology.) A related technology, real-time, fluorescent, nearinfrared cholangiography also may image the biliary tree.

Visualization of the pelvic nerve plexus. Using the high-definition magnification of the robotic optical system, the pelvic plexus of nerves can be seen and protected. The thought is that protecting this delicate and critical latticework of autonomic nerves will preserve continence and sexual functioning. This has yet to be proven in clinical trials. Laparoscopic surgeons will point out that the nerves are seen during laparoscopic interventions as well, thus negating the promoted critical view of the autonomic plexus in robotic procedures. More study is needed to clarify this point.

Weaknesses and Drawbacks The robotic system has a few drawbacks.

An important clinical drawback is the lack of both tactile sensation and tensile feedback to the surgeon. Thus, tissue damage can occur unintentionally during traction by the robotic arm and during movement of the robotic instrument.

Learning safe robotic surgery is associated with a steep learning curve.

Importantly, robotic technology seems to put the eyes of the surgeon closer to the operative field; an advantage and a drawback as the view of the

With the inevitable development of new equipment and experience, coupled with a never-ending drive to advance in fertile directions, surgeons and industry have begun to look again at robotic technology. operative field is often “too close” and a larger frame of reference is required in order to get the “big picture.”

Ureteral catheters may be placed before beginning the robot-assisted operation. As robot-assisted procedures are associated with limited tactile sensation, lighted catheters may better improve ureteral identification. The catheters may assist in visual confirmation, identification and added protection of the ureters. This practice varies by institution and by surgeon, depending on factors related to training and personal preference. The use of catheters also may be related to the surgeon’s initial comfort with robot-assisted procedures. The use of ureteral catheters may decrease over time. More study is needed to evaluate the use and safety of robotic colon procedures with respect to genitourinary complications.

A dedicated team must be assembled and trained to allow for consistency, safety and reliability in the conduct of the operation.

The robot is an expensive system. A new system can cost up to $1.5 million to purchase, and, as in laparoscopic surgery, each operation can require the use of more expensive, single-use equipment.

Service contracts are required. As of now, the manufacturer has no competitor and no competitive pricing pressure beyond the current regulatory forces. Clearly, there is a financial impact of added operating time, materials and personnel needs.

Is ‘No Worse’ the Same as ‘Better’?

There are studies showing that the results after robotic procedures are “no worse” than laparoscopic procedures.

However, there are no prospective, randomized controlled trials demonstrating a clear-cut advantage of this new technology when compared with the now “traditional” laparoscopic technology. Unlike a urethral anastomosis, the colorectal anastomosis is no different between laparoscopic and robotic techniques, negating an important potential advantage of the robotic system.

The Smaller Questions Surgeons are now performing most colorectal procedures using either laparoscopic or robotic technology. Our surgical group is transitioning to performing an ever-increasing number of robotic-assisted operations. New technologies usually engender new questions. Are there challenges in colorectal procedures that can be

overcome, or clinical outcomes that can be improved by using robotic techniques? In both laparoscopic and robotic systems, the technical aspects of the operation are similar. Surgical principles remain unchanged.

It is our (mechanical) hands that are different in robot-assisted operations. The view and clarity of the operative field and the precision of the surgeon’s movements are unrivaled. In many instances, the robotic optical view is improved over the view during laparoscopic procedures. Dissection is delicate and atraumatic. However, is one technology better than the other? Is robotic colorectal technology an advance? Are we improving the results for our patients? Can hospitals and society afford the expensive robotic system? And, specifically in colorectal surgery, are we on the cusp of another surgical revolution? Is robotic surgery a fancy gimmick and sales tool, or perhaps a technology looking for another diseased organ system to repair?

Many questions, few answers … so far.

The Big Questions In science, a properly framed question is worth more than a king’s ransom. It is worth more than all of the equipment in all of the labs in all of our research facilities. Frame your question wrong, and you might as well not even take the first step down the road of experimentation. The game is over before the first reagent hits the first test tube. But, frame your question well, frame it in your mind before even putting pen to paper or fingers to keyboard, and the results will jump out at you in ways almost unimaginable.

And so it is with robotic surgery.

Everyone has an opinion and an answer.

To be sure, all questions about patient care are important. And, as robotic technology spreads into new arenas, new questions must be asked as old questions resurface.

However, the top-level questions must be asked first in order to appropriately frame the subsequent debate and evaluation.

So, here are the top-level questions: Should the robot be allowed into our surgical thinking and then into our operating rooms?

Here are the top-level answers: Yes and yes.

And here is why: It does not matter at all what the robot can do for us today.

It matters a heck of a lot what the robot might do for us tomorrow. We explore space, we explore the ocean’s depths and we explore our bodies down to our electrons. We do these things because we are curious and because we can. And,

from this curiosity we have penicillin and x-rays. We have stethoscopes and ophthalmoscopes, and all of the incredible tools of our craft. We have automobiles, although horses worked just fine.

We have computers and software for all kinds of problems. We have telescopes in space. And we have pacemakers, electron microscopes, CT scanners and magnetic resonance scanners. We have artificial joints coated with Trabecular Metal. The list is endless and is a catalogue of human advances. In fact, everything that we have today is because we invented it all yesterday.

Think of robotic-assisted surgery as an experiment: an experiment that may or may not yield results. It might prove meaningless. Or, it might lead to the development of artificial intelligence algorithms that will save lives, maybe even save lives in remote locations or remote planets. Who knows? But it is worth trying. It matters that in developing robotic technologies, we might just invent something totally unexpected, something that none of us can see now through our short-term lenses. We must think longer term. We must look further. We must go beyond small questions to big questions, to huge questions. And from this questioning will come small and large advances for all of us. We need to advance. To stand still is … to stand still. We need to keep moving forward, because we can. Robotic technologies are a part of this progress.

Robots R Us? A Few More Answers (Beginning With the Big Answer) Should we be using the robot in the operating room? Yes. We may not know where this technology will lead us, but the story of mankind runs in lockstep with invention and exploration of all of our frontiers.

Is performing a robotic colorectal procedure exciting and fun? Yes. Are robotic-assisted procedures being performed in our community and at our hospital? Yes. Surgeons of many specialities are in various stages of learning and adoption, and are evaluating the clinical applications of robotic-assisted operations. It is an intense learning process, and the field of robotic surgery is a rapidly evolving work in progress at both the national and personal levels.

Is robotic surgery safe? Yes, in trained surgical hands. (Remember, first do no harm.)

What about the learning curve?

It is steep, very steep. For “traditional” surgeons, it involves didactic training, much practical training and “muscle memory” retraining. The curve is likely not as steep for the “younger surgeons” see ROBOTIC SURGERY page 6

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Opinion

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ROBOTIC SURGERY jcontinued from page 5

who already live in a high-tech, surgical and video game world.

Is laparoscopic surgery presently the most commonly used surgical system in minimally invasive general surgical and colorectal operations? Yes. Will laparoscopic, minimally invasive surgery remain the most commonly used system in minimally invasive general surgical and colorectal operations for some time to come? Yes. Is today’s robotic colorectal surgery

an advance over our current laparoscopic techniques? Yes, in certain clinical situations.

Does robotic surgery have the potential to become the procedure of choice for the resection of pelvic tumors, leftsided tumors and complicated resections or reoperative resections, as well as in intraabdominal rectocele repair and enterocele repair? Yes. Do colorectal robotic systems allow for better clinical outcomes when compared with laparoscopic procedures?

Possibly, for certain clinical applications. Much study is needed to clarify

this point, however.

Are the results using robotic tools “no worse” than the results in laparoscopic surgery? Yes. (Remember, first do no harm.)

Is the promoted advantage of “greater visibility” using robotic technology an operating room advance when used in colorectal surgery? Possibly, especially if it turns out that nerve visualization and protection, and intraoperative vascular anastomotic perfusion evaluation are found to relate to improved clinical outcomes. Again, more study is needed to look at clinical outcomes.

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Finally, is someone, somewhere working on an artificial intelligence program that will guide the robot-surgeon (or surgeon-robot) through an operation? Yes.

A Tool, a Toy and an Advance Ultimately, as with any new intervention, the decision to use a robotic system in the operating room will depend on a clinical benefit analysis. There appears to be increasing acceptance and use of robotic technologies in many common operative interventions. The technology has improvements and advances over open surgical procedures and laparoscopic technologies as well. However, it will take the combined evaluations of both “traditional” and “young” surgeons to decide if the robot is a tool, a toy or an advance.

Disclosure The authors report no financial relationship with Intuitive Surgical.

—The authors are surgeons at Los Angeles Colon and Rectal Surgical Associates (www.lacolon.com) and instructors in the Division of Colon and Rectal Surgery and in the Colorectal Surgery Fellowship of Cedars-Sinai Medical Center, Los Angeles, California.

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© 2014 Vector Surgical, LLC 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

In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / FEBRUARY 2014

Fecal Transplant Rivals Antibiotics for C. difficile in Cost Model B Y M ONICA J. S MITH SAN DIEGO—Fecal microbiota transplant (FMT) has been rapidly gaining ground as a treatment for recurrent Clostridium difficile infection (CDI), showing in one study after another to be safe and often more effective than conventional therapies. A new study presented at the American College of Gastroenterology 2013 Annual Scientific Meeting supports the cost-effectiveness of this procedure as well.

The growing incidence of CDI and the high cost of drugs used to treat it has resulted in soaring health care costs related to management of the infection. CDI has become particularly more difficult to manage since the emergence of the 027 strain, which has resulted in lower cure rates and increased resistance to treatments. Additionally, the rate of recurrence is growing: As many as one-third of patients experience a recurrence after an initial infection, and up to two-thirds of those patients experience further recurrent infections.

“All of this has resulted in a high economic burden of over $1 billion annually,” said Gauree G. Konijeti, MD, MPH, a fellow in gastroenterology and hepatology at Massachusetts General Hospital and Harvard Medical School, in Boston.

“We manage an initial infection with metronidazole or vancomycin, and recurrences with either of these two antibiotics or fidaxomicin,” Dr. Konijeti said. “FMT has emerged as a highly effective therapy because of high cure rates and low rates of recurrence.”

Given that background, Dr. Konijeti and her colleagues constructed a decision-analytic model to compare the cost-effectiveness of four treatments for recurrent CDI: metronidazole, vancomycin, fidaxomicin and FMT. The model used a patient cohort with a median age of 65 years with mild to moderate CDI. Potential outcomes following treatment were cure without recurrence, cure with recurrence or nonresponse. The cost of FMT was modeled to include the cost of donor testing, recipient testing, FMT preparation and instillation, four-day preprocedural treatment with vancomycin and the cost of the procedure itself (administration via colonoscopy, upper endoscopy or enema).

The researchers devised a clinical scenario in which two additional recurrences occurred following the first recurrence of CDI. Based on clinical practice guidelines, patients who received metronidazole for a first CDI recurrence were given vancomycin for a second recurrence and a vancomycin pulse/taper for a third

recurrence. Those given vancomycin or fidaxomicin for a first reccurrence received a vancoomycin pulse/taper for a second recurrence and FMT for a third. Patients who received FMT foor a first recurrence underwentt FMT again for a second recurreence and a vancomycin pulse/taaper for a third.

In the primary an nalysis, FMT a dministered vvia colonoscopy was the most p cost-effe fective strategy, showing an a incremental cost-effecctiveness ratio (i.e., tthe additional cost per additional unit of effectiiveness gained) of approximatelyy $38,000.

“FMT also dominated metronidazole and fidaxomicin, which means that it was both more effective and less costly than the either of those two antibiotics,” Dr. Konijeti said.

The researchers also looked at the cost of FMT delivered via duodenal infusion and enema, but they found both strategies to be cost-prohibitive, mainly because of lower one-time infusion cure rates. They acknowledged that if cure rates with these see FMT page 8

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In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / FEBRUARY 2014

Metabolic Syndrome Tied to Pulmonary Issues After Bariatric Surgery B Y M ANDY A RMITAGE , MD SAN FRANCISCO—Patients with metabolic syndrome who undergo bariatric surgery are more likely to experience pulmonary complications after the procedure than are those without the syndrome, a new study has found.

In a previous study, researchers from Tufts Medical Center, in Boston, found that roughly 1% of patients undergoing weight loss surgery experience postoperative pulmonary complications, including pneumonia, pneumothorax and atelectasis. But the latest work is the first to connect metabolic syndrome (MetS) with such problems in these patients.

“There have been studies with MetS surrogates that have looked at mortality, but not specifically pulmonary complications. This topic was attractive because this particular database in a specific patient population consists of prospectively collected information, including patient conditions,” said Roman Schumann, MD, vice chair for academic affairs in the Department of Anesthesiology at Tufts, who led the study. Dr. Schumann presented his team’s findings at the 2013 annual meeting of the American Society of Anesthesiologists (ASA; abstract BOC05).

Comorbid conditions of MetS, such as obesity, dyslipidemia, hypertension and glucose intolerance, often improve after bariatric surgery, according to the researchers. However, the incidence of MetS among obese patients who undergo bariatric surgery has not been well studied.

The longitudinal database is a prospective collection of data from participating bariatric centers of excellence and is affiliated with the American Society for Metabolic and Bariatric Surgery and the Surgical Review Corporation, a nonprofit company that accredits centers of excellence in bariatric surgery. The Tufts team looked at data covering procedures between January 2008 and December 2010 and included demographics, procedural information, ASA status (≥2), the presence or absence of MetS-associated comorbidities and pulmonary complications.

Dr. Schumann and his colleagues analyzed data from

FMT

jcontinued from page 7 techniques could be brought up to 89%, these two delivery strategies would be preferable to treatment with antibiotics as well.

Sensitivity analyses revealed that FMT via colonoscopy would remain the preferred strategy if the CDI recurrence rate following the procedure were lower than about 10%; for recurrence rates higher than 10%, the preferred strategy would be vancomycin.

Vancomycin was the most cost-effective initial treatment in situations where FMT was not available. In this scenario, competing antibiotic therapies with an efficacy similar to fidaxomicin would need to cost less than about $1,500 to be considered cost-effective.

158,405 primary bariattric procedures (52% gastric bypass; 40% gastriic banding; 4% sleeve gastrectomy). Pulmon nary complications included atelectasis, pn neumonia, pneumothorax, pleural effusion,, respiratory failure and acute respiratory disttress syndrome.

The mean patient agge was 45.7 (±11.8) years, and 78.5% were women. The majority of patients (65.3%) had an ASA physical status of 3.

MetS was present in 20,158 patients, or 12.7% of th he total.

A significant associatioon was found between MetS and all pulmonary compliccations except pneumothorax. Pneumonia and respiratory failure were most strongly associated (both P<0.001).

“It is unclear wh hether the presence of MeetS merely reflects a generaally impaired physiologiccal status that explains these se findings, or whether the particular combination of the defining comorbidities is responsible,” the authors concluded. “Medical optimization of patients with MetS prior to surgery appears to be warranted.”

Stephanie B. Jones, MD, president of the International Society for the Perioperative Care of the Obese Patient and associate professor of anesthesia at Harvard Medical School and Beth Israel Deaconess Medical Center, both in Boston, said the results were unsurprising. “I personally feel that obesity hasn’t gotten the full attention of anesthesiologists because the majority of patients do fine, but with MetS, that’s where you start seeing the higher risk population. That’s who we should be looking at going forward, in terms of prospectively intervening.”

Dr. Schumann added, “We don’t really know if these patients are just sicker and it makes sense that they run into trouble after surgery, or if it’s a special combination

“In summary, a strategy consisting of first-line treatment with FMT colonoscopy for an initial recurrence of CDI appeared cost-effective at conventional willingness-to-pay thresholds,” Dr. Konijeti said.

“Guidelines should consider earlier use of FMT in the treatment of CDI, and future studies should incorporate FMT for comparative effectiveness,” she concluded.

The study’s findings came as no surprise to Colleen Kelly, MD, clinical assistant professor of medicine, Brown Alpert Medical School at Brown University, and a gastroenterologist at the Center for Women’s Gastrointestinal Medicine, both in Providence, R.I. “Those of us who do FMT have known its cost-effectiveness, which is obvious when you have such amazing cure rates

of changes that puts them at higher risk for certain adverse outccomes. We suspect inflammatory changes in the physiology may play an important not yeet defined role in some of these observations.”

Dr. Jones saiid, “Part of the problem with these studies on MetS M in general is that the definition has been soort of a moving target. But I do think it’s MetS rather than the comorbidities individuaally.”

In an unrelated study presented at th he 2013 PostGraduate Assemblyy in Anesthesiology, New York Ciity researchers found that a diaagnosis of obstructive sleep ap pnea (OSA) and being overweeight independently predicted a patient’s odds of being transfeerred to a step-down unit after ssurgery (P-9006).

“Transfers reflect patient outcomes and clinical decisions undertaken to prevent morbidity and mortality, suggesting increased postoperative complications in the OSA and the higher” body mass index, the authors wrote.

Naum Shaparin, MD, director of the Pain Service in the Department of Anesthesiology at Montefiore Medical Center, in New York City, who helped conduct the study, said patients who use continuous positive airway pressure (CPAP) machines at home are “automatically continued on CPAP postoperatively.” However, CPAP generally is not started postoperatively on other patients, for fear that the increased pressure into the esophagus and stomach might adversely affect the surgical site, Dr. Shaparin said.

Dr. Shaparin said the results have not changed practice at Montefiore—yet. “Once the final analysis is complete, we will arrange to present the data to the bariatric surgeons and the administration,” he said. “So, at the moment, there has been no change but we expect there will be a change once the data is presented.”

‘FMT has emerged as a highly effective therapy because of high cure rates and low rates of recurrence.’

—Gauree G. Konijeti, MD, MPH compared to the other agents, which are quite expensive,” she said.

Dr. Kelly suspects the cost advantage of FMT in this study would have been even greater if the researchers used a population of sicker patients in their model.

“We see people who, with each case of CDI, get admitted to the hospital, with all the costs associated with that,” Dr. Kelly said. “If you looked at a more severely ill group of patients, I think you would find FMT even more cost-effective.”

In the past year or so, Dr. Kelly has started administering FMT via sigmoidoscopy, both to avoid the cost associated with colonoscopy and to avoid subjecting patients to colonoscopy more often than necessary, especially if it meant scheduling a hospital-based procedure.

Sigmoidoscopy offers several advantages over other modes of FMT instillation: Patients do not need to be sedated as they do with colonoscopy, and they are more likely to retain the dose long enough for it to take effect, which can be difficult to achieve with an enema.

“It doesn’t have to be all or nothing— full colonoscopy or enema,” Dr. Kelly said, referring to the cost-effectiveness of sigmoidoscopy. “Also, we’re hoping that some of the oral formulations [being investigated] will remove that whole cost from the picture.”

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Obesity Care

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / FEBRUARY 2014

‘Healthy’ Obese Patients More Likely To Receive Acute ASA Status B Y M ICHAEL V LESSIDES SAN DIEGO—Although the American Society of Anesthesiologists’ physical status classification system has proven to be an important predictive tool, its value may be degraded by consistent “up-classification” of obese patients. A recent analysis of more than 300,000 patients found that obese individuals are more likely to be classified as ASA II to IV than their

normal-weight counterparts, regardless of their overall health.

“One of the things that has haunted ASA classification over the years is the question of interobserver variability,” said Christopher H. Guerry, MD, an anesthesia resident at Virginia Commonwealth University in Richmond. “And it is in the setting of obesity in which we find some of the greatest interobserver variability.”

Given that such inconsistencies can degrade the predictive value of surgical

outcome models that use ASA physical status as a risk input, Dr. Guerry and his colleagues examined trends in the classification system across body mass index (BMI)-based categories between 1986 and 2010 in both emergent and nonemergent surgical cases. Researchers stratified 302,829 patients (ages 18-89 years; mean, 48) according to BMI, after which they determined the relative risk for up-classification according to ASA physical status.

As Dr. Guerry reported at the 2013

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SAGES 2014

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April 2 - 5, 2014 · Salt Lake City, UT Wednesday, April 2 SAGES/CAGS/ERAS Full-Day Postgraduate Course: Enhanced Recovery After Surgery Pathways SAGES/ASMBS Half-Day Postgraduate Course: Endoscopic Management of Bariatric Complications Symposium: Career Development SAGES/SSAT Panel: Optimizing Results of Fundoplication SAGES Foundation Awards Luncheon 12:00pm - 1:30pm SAGES/ASMBS Half-Day Hands-On Course: Endoscopic Management of Bariatric Complications Panel: Getting Your Video Accepted Panel: POEM Panel: Reoperative Pelvic Surgery, Benign and Malignant Panel: FUSE, Fire and Fiasco – OR Safety 101 Panel: Product Development – Innovations for Patients Benefits Updates in Benign CRS Panel Exhibits Opening Welcome Reception 5:30pm - 7:30pm

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Program Chairs: Tonia Young-Fadok, MD, MS & Jeffrey Marks, MD

Friday, April 4 Exhibits/Posters/Learning Center open 9:30am - 4:00pm Full-Day Military Surgical Symposium Scientific Sessions - Video 2; NOTES; Quick Shots 1 SAGES/JSES Panel: Endoscopic Submucosal Dissection Plenary Session 1 Presidential Address – Gerald Fried, MD 10:00am - 10:45am Gerald Marks Lecture – Amitai Ziv, MD 10:45am - 11:30am Scientific Sessions - Education; Outcomes; Bariatric 1; Basic Science Fellowship Council Luncheon 12:30pm - 1:30pm Postgraduate Course: Humanitarian The Great Presidential Debates of 2014 Panel: Emerging Frontiers in Simulation – Based Surgical Education SAGES/ALACE Panel: Evolution and Clinical Applications of Minimal Access Surgery in Latin America Panel: MIS Jeopardy Session: Emerging Technology Panel: MIS for Acute Care Surgeons SAGES/EAES Panel: Benign Foregut Resident/Fellow Scientific Session Meet the Leadership Reception 6:00pm - 7:00pm Main Event - SAGES Gala & Sing-Off 7:00pm - 11:00pm

Saturday, April 5 Exhibits/Posters/Learning Center open 10:00am - 12:30pm Scientific Sessions - Hernia; Robotics/Ergonomics; HPB Plenary Session 2 Panel: Bariatric Complications for the non-Bariatric Surgeon Panel: Why Haven’t Conversion Rates Improved?

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Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) 11300 W. Olympic Blvd., Suite 600 · Los Angeles, CA 90064 · Phone: 310-437-0544 · Fax: 310-437-0585 · Email: sagesweb@sages.org

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annual meeting of the International Anesthesia Research Society (abstract S-153), 10.9% of patients were classified as ASA I, 47.7% as ASA II, 32.5% as ASA III, 8.4% as ASA IV and 0.6% as ASA V. Over the study period, the percentage of surgical patients who were of normal weight fell from 42% to 29%, whereas the proportion of obese patients rose from 20% to 39%.

Compared with normal-weight patients, individuals with higher BMI were more likely to be up-classified on the ASA scale.

“One of the arguments you can make is that an increasing prevalence of comorbidities is a big part of increasing BMI, which would obviously be part of the classical definition of ASA physical status,” Dr. Guerry said. “So we looked at a subgroup of patients aged 18 to 25, the ones in which a diagnosis of comorbidities would be less likely.”

Yet the up-classification association was more pronounced for these younger patients.

“Although the ASA classification system was not originally designed to be a risk predictor, there has been a lot of interest recently in coming up with complex models for predicting outcomes with it,” Dr. Guerry said. And as it turns out, the system has been highly predictive.

“But obesity adds inconsistency to the classification system, and with obesity rates increasing, we’re introducing a certain amount of uncertainty into these predictive models,” he continued.

“So we can spend time debating whether or not it’s legitimate to up-classify obese patients, but the most important thing is that as a professional community we need to be consistent. Once consistent, then we can go back and look at the predictive value of the ASA classification system in these patients.”

Charles B. Watson, MD, chief of anesthesia and deputy surgeon in chief at Bridgeport Hospital in Bridgeport, Conn., said there are legitimate reasons for counting marked obesity as a factor in assigning an ASA physical status.

“The ASA [classification] was designed to predict the difficulty of the anesthetic, not outcome, and many of us believe that very obese patients are more difficult to care for,” Dr. Watson said. “Many arguments for and against the issue of whether obese patients, smokers, infants and others should be ASA I or II have been bandied about over the years. Most of us believe that very heavy patients are more likely to have comorbidities and worse outcomes, although there are published series showing ‘acceptable’ preoperative morbidity in this population.”

Obesity Care

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / FEBRUARY 2014

There Is No Such Thing as ‘Healthy Obesity’! [[Editor’s note:: The following editorial was first published in Missouri Medicine, January/February 2014 issue.]

B Y M. J AVED A SHRAF , MD, MPH

O

verweight and obesity are the fastest-growing causes of morbidity and death in the United States. Obesity is a chronic metabolic disorder associated with increased cardiovascular morbidity and mortality. However, despite the fact that obesity is associated with increased health hazards, in recent years there have been some confusing and contradicting reports of “healthy obesity,” “benign obesity” and “obesity paradox.” These reports unfortunately have tried to undermine the severity of this alarming problem.

Dr. Caroline Kramer and colleagues highlighted the worsening obesity issue in their meta-analysis published December 2013 in Annals of Internal Medicinee (Ann Intern Med. 2013;159:758-769). They reported increased incidences of cardiovascular disease and all-cause mortality among obese adults for both metabolically unhealthy and metabolically “healthy” people of various weights and emphasized “there is no such thing as healthy obesity.”

The authors compared the cardiovascular and all-cause mortality for healthy and unhealthy obese groups. In their meta-analysis with a follow-up of 10 years, metabolically healthy obese adults had an increased risk for all-cause mortality and cardiovascular disease. The data for their study came from eight prospective studies published during the past decade. Metabolic health was defined by the presence or absence of metabolic syndrome as per Adult Treatment Panel III (ATP III) criteria or by the International Diabetes Federation. Excess weight is associated initially with subclinical metabolic and vascular dysfunction that ultimately leads to increased cardiovascular events and mortality.

The concept of “benign obesity” originated from reports that evaluated metabolically healthy obese individuals over a short period of time. The authors claim their results do not support this concept of benign obesity. I applaud Dr. Kramer and her colleagues on their excellent work to clarify that there is no healthy pattern of obesity. In fact, the metabolically unhealthy adults, including those of mild obesity, exhibited the highest relative risk for cardiovascular events and allcause mortality.

My colleague and I also highlighted the increased cardiovascular risks in obesity as well as among “normal weight obese” (NWO) individuals in our review article recently published in Missouri Medicine

(2013;110:499-504). NWO adults have increased atherosclerotic plaques in their arteries and worse clinical outcomes than those who have normal or smaller waist-to-hip ratios. NWO individuals have an increased risk for diabetes and cardiovascular disease compared with individuals who are metabolically healthy and of normal weight.

I strongly suggest that clinicians pay more attention to this group of NWO individuals as they are likely to perceive

[In this study], the metabolically unhealthy adults, including those of mild obesity, exhibited the highest relative risk for cardiovascular events and all-cause mortality.

themselves as healthy. Irrespective of metabolic status, if someone is obese or has normal weight obesity, he or she should be considered at risk. The data from Kramer et al’s meta-analysis further strengthen the fact that obesity at any level or severity is not a benign condition and is never healthy.

—Dr. Ashraf is a cardiologist at the — University of Missouri-Kansas City School of Medicine.

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

No increased risk was observed in short-term trials.

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

Contraindications

› ENTEREG Capsules are contraindicated in patients who have

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

Warnings and Precautions

› There were more reports of myocardial infarctions in patients

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

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

›

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

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

Adverse Reactions

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

E.A.S.E.® Program for ENTEREG

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

– Hospital staff who prescribe, dispense, or administer

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

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

Please see following brief summary of Prescribing Information.

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

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

11

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In the News TELOMERES

jcontinued from page 1 The Obesity Society.

Over the past decade, there has been increased attention focused on telomeres.

Often likened to the tips on the ends of shoelaces, telomeres are responsible for maintaining chromosome stability.

Every time cells replicate, the telomere frays and shortens, losing some genetic material in the process. Shortened telomeres have been linked to higher rates of cancer, neurodegenerative diseases and mortality.

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / FEBRUARY 2014

But although researchers understand more about what happens as telomeres lose integrity, little is known about how to prevent it. It is believed that interventions to prevent telomere shortening could increase longevity and decrease incidence of age-related dementia ((Arch Neurol 2012;69:1332-1339).

Obesity is one of the drivers of telomere shortening and experiments in mice suggest that obesity increases the formation of reactive oxygen species in fat cells and shortens telomeres (Nat Med 2009;15:996-997). Based on these findings, Dr. Morton and his colleagues

set out to look at whether weight loss induced by bariatric surgery could influence telomere length.

They studied 55 patients with a mean age of 48.5 years who underwent laparoscopic gastric bypass for obesity and telomere analysis by Telomere Diagnostics, Inc. Overall, patients’ telomere length remained relatively stable, measuring 0.987 (relative to 1.0) preoperatively and 0.982 one year after surgery (P=0.764).

P But specific groups of patients showed remarkable improvements in telomere length, particularly those with

BRIEF SUMMARY

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

In vitro, ENTEREG did not inhibit p-glycoprotein.

7.3

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

‘If indeed the weight loss does have a positive effect on preservation of DNA and how it functions, that is a remarkable finding.’

—Bruce Wolfe, MD the highest preoperative levels of lowdensity lipoprotein cholesterol (LDLC) and C-reactive protein (CRP).

Patients with high preoperative CRP, defined as 7 at baseline, demonstrated a 2.83% increase in telomere length one year after surgery. Patients with high LDL-C preoperatively, defined as greater than 140 at baseline, showed a 1.62% increase in telomere length.

“I look at it this way: It’s the sickest patients—those with the worst cholesterol, the most inflammation—who got the most benefit,” explained Dr. Morton.

The findings suggest that there may be a way to determine who will have the best results from bariatric surgery, an issue that will become even more important in the next few years under health care reform, said Bruce Wolfe, MD, professor of surgery at Oregon Health & Science University in Portland. Dr. Wolfe was not involved with the study.

“A fundamental question in bariatric surgery is how can we determine beforehand who will have a very good operation so we can focus the selection of patients,” he said.

“What this study showed, as I interpret it, is that the gastric bypass and resultant weight loss led to restoration of telomere function and chromosomal preservation. If indeed the weight loss does have a positive effect on preservation of DNA and how it functions, that is a remarkable finding.”

Dr. Wolfe cautioned that although the study provides proof of concept, much more information is needed.

Currently, the investigators have expanded the study and plan to conduct telomere analysis on more than 1,500 patients who underwent gastric bypass as part of the National Institutes of Health research consortium on bariatric surgery, known as LABS. Such a study would provide more information what happens to the telomeres of bariatric surgery patients, particularly in the long term. Dr. Wolfe is co-chair of LABS. It is unknown if telomere erosion itself contributes to aging or if it is a reflection of the aging process. That’s a question for future research, said Dr. Morton.

Dr. Morton disclosed that he has served as a consultant to Covidien and Ethicon. Dr. Wolfe reported no relevant financial relationships.

In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / FEBRUARY 2014

SYNTHETIC MESH jcontinued from page 1

in the hands of surgeons with expertise and experience in abdominal wall reconstruction, one can achieve equivalent if not better short-term outcomes with lightweight, macroporous, permanent synthetic mesh compared with biologic mesh in clean-contaminated or contaminated open ventral hernia repairs,” said lead author Jaime A. Cavallo, MD, MPHS, a surgical research scholar at Washington University in St. Louis.

Investigators compared outcomes for 89 patients who underwent repair with biologic mesh and 111 who underwent repairs with permanent synthetic mesh, between 2007 and 2013 at two medical centers.

Surgical site occurrences were reported more often after repair with biologic mesh than synthetic mesh (46.07% vs.

29.73%; P P=0.0173). Surgical site occurrences requiring procedural intervention were also higher in the biologic mesh group (17.95% vs. 9.01%; P=0.0615), P although the difference was not statistically significant.

The durability of biologic mesh remains a topic for discussion. Longterm studies have reported recurrence rates in the range of 50% with biologic mesh. In this study, 29.21% of patients who received a biologic mesh implant developed a recurrence, with a mean follow-up of 19.98 months. In comparison, 7.21% of patients who received a permanent synthetic mesh had a recurrence, but the follow-up period of this group was considerably shorter at only 7.96 months.

The differences in follow-up make it impossible to compare long-term recurrence between the two styles of mesh.

Centers for Disease Control and Prevention (CDC) measures require follow-up of at least one year to identify synthetic mesh infection, noted B. Todd Heniford, MD, professor of surgery and chief of gastrointestinal and minimally invasive surgery, Carolinas Medical Center, Charlotte, N.C. “This is an excellent start, but I do have concerns that this study is short term and there could be the potential for selection bias in the choice of a lightweight synthetic mesh versus a biologic mesh. In the context of complicated patients, you would expect surgeons to frequently choose a biologic mesh,” Dr. Heniford said.

He added that the study does demonstrate that the current philosophy that synthetic mesh should only be used in truly clean cases “needs to be challenged.”

“Perhaps this study is telling us something about biologic mesh, inferring a higher rate of wound complications because of its processing, sterilization or

other properties. We also know that one biologic implant does not behave identically to another. The answers to these questions are important and need to be answered in a randomized, prospective study.”

Synthetic meshes currently being used differ greatly from those used 15 years ago. Current synthetic meshes are lightweight, wide-pore monofilament meshes, which are less prone to infection than the heavyweight, close-knit meshes of the 1990s. Animal data show these meshes are more resistant to bacterial colonization and bacterial clearance. Unlike

earlier-generation synthetic meshes, some studies have demonstrated that the newer meshes can be salvaged following contamination. Synthetic meshes also cost considerably less than biologics.

These developments have led to the reevaluation of the role of permanent synthetic mesh for open ventral hernia repair in clean-contaminated and contaminated surgical sites.

In this study, four surgeons from University Hospitals Case Medical Center, Cleveland, and Greenville Health System University Medical Center, Greenville, S.C., completed the repairs. Patients

were well matched in terms of age, body mass index and CDC wound class. Synthetic meshes were placed more often in a retrorectus position (91.89% vs. 67.42%) and less often in the intraperitoneal space (1.08% vs. 31.48%).

To further investigate these findings, the authors are currently conducting a multicenter, prospective randomized trial of biologic versus permanent synthetic mesh in clean-contaminated and contaminated ventral hernia repairs under appropriate FDA Investigational Device Exemptions (ClinicalTrials.gov NCT01746316).

13

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In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / FEBRUARY 2014

Surgery Not Helpful in De Novo Metastatic Breast Cancer Results From India May Not Apply To U.S. Women Due to Lack of Targeted Therapies B Y K ATE O’R OURKE SAN ANTONIO—Clinicians should not routinely remove the primary tumor and axillary lymph nodes in women who present with metastatic breast cancer (MBC), according to results from a

randomized controlled trial.

“Locoregional treatment [LRT] of the primary tumor in women presenting with MBC did not result in any overall survival benefit and hence should not be offered as a routine practice,” said Rajendra Badwe, MD, director of the Tata Memorial Hospital, Mumbai, India. He presented the study at the recent San Antonio Breast Cancer Symposium (SABCS; S2-02).

The role of surgery in de novo MBC

has been controversial. Conventional wisdom suggests surgery should only be performed in women with MBC if there are fungating soft tissue masses and/or bleeding of the tumor. Animal models of metastatic disease show that removing a primary tumor releases factors that rapidly increase the growth of metastases (Cancer Res 1989;49:1996-2001).

Five retrospective, single-center studies have demonstrated that surgery in women with MBC did not improve

A Valuable Alternative to Biologics f or complex sof t tissue reinf orcement.

survival. However, eight retrospective, singlecenter studies and four registry trials have demonstrated the opposite.

“The house remains divided as to whether we should be performing surgery or not,” said Dr. Badwe.

To clarify the issue, between 2005 and 2013, investigators in India enrolled 350 women who presented with MBC and had an objective tumor response to six cycles of chemotherapy (anthracyclines with or without taxanes). Patients were randomized to receive LRT (n=173) or no LRT (n=177). The two arms were well balanced in terms of patient age, site and number of metastases, and hormone and HER2 receptor status. In both arms, roughly 50% had both bone and visceral metastases and 50% were hormone receptor–positive.

‘This is the first time that we have evidence in human studies that locoregional treatment has a great kinetic effect on distant metastases.’

—Rajendra Badwe, MD

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Patients who received surgery with or without ovarian ablation also received radiotherapy and hormone therapy if indicated. Patients who did not undergo surgery received hormone therapy if relevant and ovarian ablation when indicated.

There was no difference in overall survival (OS) between the two arms (hazard ratio [HR], 1.04; 95% confidence interval [CI], 0.80-1.34; P=0.79).

No survival advantage to having LRT was observed in any of the subgroups, divided by menopausal status, hormone and HER2 receptor status, and site and number of metastases. The median OS was 18.8 months in patients who received LRT and 20.5 months in patients who did not, a difference that was not statistically significant.

The lack of survival benefit appeared to be due to a tradeoff between local control and distant disease progression.

The surgery group, as anticipated, had significantly better local progressionfree survival (HR, 0.16; CI, 0.10-0.26; P=0.00), but the no-surgery group had an advantage in distant metastasis-free

In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / FEBRUARY 2014

survival (HR, 1.42; CI, 10.8-1.85; P=0.01).

“This is the first time that we have evidence in human studies that locoregional treatment has a great kinetic effect on distant metastases,” Dr. Badwe said.

Tari King, MD, a breast cancer surgeon and Jeanne A. Petrek Junior Faculty Chair at Memorial Sloan-Kettering Cancer Center in New York City, said it is unclear whether the study results can be applied

to women in the United States who have greater access to targeted therapies, such as those with HER2-positive breast cancer who receive HER2-targeted therapy. None of the patients in the trial received HER2-targeted therapies. “I’m not sure we can apply the data to women treated with modern targeted therapy regimens that we use in the United States,” Dr. King said.

Dr. Badwe’s results, however, are largely in line with a Translational Breast Cancer Research Consortium study that Dr. King presented at SABCS (P2-18-09). This study showed

15

that in 127 women with de novo stage IV breast cancer, surgery, estrogen receptor and HER2 status were associated with improved OS, but when response to systemic therapy was taken into account, elective surgery did not further improve OS. Dr. King pointed out that the twoyear OS of patients in her study was 94%, whereas in Dr. Badwe’s study it was 41% in the surgery arm and 43% in the no-surgery arm. The difference is a testament to access to targeted therapies.

FDA Seeks Electronic Records For Drug Safety Data As part of the FDA’s ongoing efforts to evaluate the safety of drugs and biological products, the agency quietly began a search for access to electronic health records (EHRs) in December. The agency plans to use the information gleaned from EHR data to augment its MedWatch reporting system and other actions taken by the FDA’s Office of Surveillance and Epidemiology.

In a notice posted to Federal Business Opportunities, a website used by government agencies looking to contract outside vendors, the FDA wrote that it is seeking direct and continued access to EHR data. The agency said it is “not interested [in] developing this database,” because the successful contractor would have to provide the health information for at least 10 million patients. At a minimum, 5 million of these patients would be currently active in the EHR system, and the majority of patients must have been continuously enrolled in the system for three years or longer. The FDA emphasized that the identities of all patients would be obscured.

The Prescription Drug User Fee Act (PDUFA) gives the FDA the legal authority to compile this database information, the agency said in the notice. It cited a provision in PDUFA that enables the FDA to “continue the Agency’s efforts on the standards-based information systems to support how FDA obtains and analyzes post-market drug safety data and manages emerging drug safety information.” The data provided by the contractor will allow reviewers to “evaluate drug-related safety issues of high regulatory priority in a timely manner” and assess several risk factors.

—Ben Guarino

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Opinion

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / FEBRUARY 2014

ELEVATE

jcontinued from page 1 will usuallyy climb three to four flights but take the elevator for longer ascents. Our work is physically demanding, and few of us carve out the time for physical activity that can relieve stress and improve our stamina, flexibility, and strength as well as protect our backs and joints.

Our personal mythology is that we have an inexhaustible inner reserve. In a recent New Yorkerr article, Atul Gawande reflected on the potential role of coaching for refinement of operative performance

(October 3, 2013). I would submit that there are few technical performances that are undertaken without consistent training and ongoing practice regardless of level of expertise between “real" performances.

The elevators are just one of many hospital intersections at which the dynamics of the hospital unfold. I find myself impatiently tapping a toe and grousing silently when staff board the perennially slow elevator to travel down a single floor, when the wrong floor button is pushed, or when an elevator is held to accomommodate a late arrival who hadn’t noticed the

direction arrow and backs out of the car.

These are the small aggravations of being in a hurry in a busy place. My aggravation reached a new peak a few weeks ago when I made the grave error of attempting to board a “patient transport–only” elevator on a quiet Sunday morning on what was likely my 14th day in a row in the hospital. I was reprimanded by a slight girl, a hospital transporter with a stable patient, not much insight, and an elevator carful of attitude. With self-righteousness that only an adolescent can unselfconsciously muster, she made it clear that I was interfering with patient care.

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How do we work in a system that solves problems by making rules that cater to the lowest common denominator of understanding?

I was dumbfounded. We plummeted to a new low: the sub-subbasement of regard for the physician. How have we arrived at a place in which a patient transporter— who, without a doubt, provides a very important service in the hospital—feels entitled to assert the priority of her role in patient care over that of a physician?

I worried about how our patients experience being wheeled around the hospital by staff who have so little respect for the contributions of physicians, who so unabashedly discount us as being an impediment to patient care.

I also wondered how the rule got made. How do we work in a system that solves problems by making rules that cater to the lowest common denominator of understanding? Must everything be developed so that a sixth grader can understand?

We all share the goal of transporting our inpatients comfortably, quickly and safely between destinations in the hospital, and sometimes all the staff—regrettably, physicians, too—fail to attend to this. We may not vacate an elevator to let patient transport board. We may crowd in and stop at additional floors, talk as though the patient cannot hear us and take their presence for granted.

So here’s how it would work in my utopian hospital: Instead of making a rule that both makes it more difficult to move around the hospital and sends wrong messages about who is caring for patients, I would develop a campaign that inspires us to make different choices. I would make a plan that would elevatee us.

Promote use of the stairs. Michael Bloomberg, recent past mayor of New York City, established the Center for Active Design, which has the stated purpose of “promoting health through the design of buildings, streets and neighborhoods.” Historically, public health epidemics (often related to infection control), have improved partly as a result of innovations in city design. Mayor Bloomberg

Opinion

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / FEBRUARY 2014

identified obesity as an epidemic and, among other strategies, promoted building design that encouraged walking and using stairs. This program has four components: active transportation (to encourage pedestrians, cyclists and transit riders), active buildings (to encourage greater physical movement within buildings), active recreation (to develop play and activity spaces in communities) and food access (to improve access to nutritious foods; http://centerforactivedesign. org/design-concepts).

Stairwells could be more inviting.

Imagine that each stairwell in a hospital had a theme. One could be meditative where talking was prohibited and the sound of crickets or waves or rainfall could be heard. One could be a shaft of full-spectrum light during dreary winter months. One could be painted energetic red, and salsa music could alternate every third hour with Bollywood and hip-hop to encourage taking two steps at a time.

Another could be green, a changing posting of interesting factoids on each landing about energy savings such as the actual value of using the elevator less. One could be a fitness stairwell with other factoids about how many calories are burned by climbing two flights of stairs a day or recipes that are easy and healthy, a changing 20-minute walk route around the hospital, a three-minute back stretch you can do at your deskâ&#x20AC;&#x201D;tear off a copy to take with you. There are endless possibilities.

Signage for stairwells could be better, making it clear at every elevator lobby where the nearest stairs are, numbering or naming stairways so that it becomes part of the hospital lexicon (â&#x20AC;&#x153;Iâ&#x20AC;&#x2122;ll meet you at stairway A,â&#x20AC;? or â&#x20AC;&#x153;If you take stairway 7 up to the fifth floor and take a left, my office is two doors down.â&#x20AC;?) When visitors ask for directions, information desk hosts could ask, â&#x20AC;&#x153;Would you like to take the stairs or the elevator?â&#x20AC;? Position a bench outside the door at each landing. Designate one elevator to stop at every floor ascending and descending (as the Sabbath elevator does

."26&5 JT B SFHJTUFSFE USBEFNBSL PG ."26&5 (NC) t 1SP-JUF 1SP-JUF 6MUSB 1SP-PPQ $ 263 $ 263 5BD4IJFME $ 263 7 1BUDI BOE $ 263 $FOUSJ'9 BSF USBEFNBSLT PG "USJVN .FEJDBM $PSQPSBUJPO t .$7 3&7" $"65*0/ 'FEFSBM 64 MBX SFTUSJDUT UIJT EFWJDF UP TBMF CZ PS PO UIF PSEFS PG B QIZTJDJBO 3FGFS UP *OTUSVDUJPOT GPS 6TF GPS DVSSFOU JOEJDBUJPOT XBSOJOHT DPOUSBJOEJDBUJPOT BOE QSFDBVUJPOT

in many New York hospitals).

Increase awareness of elevator needs in ways that build our sense of common purpose. Foster a culture of consideration of and commitment to the best use of this limited resource. Inspire us to be better. Make staff elevators working elevators and visitor elevators more leisurely sanctuaries where even anonymous professional discussions are avoided. Call on staff to make room for patient transporters to board and to vacate if a critically ill or intubated patient is on the move.

Have a coded expression for this, something like, â&#x20AC;&#x153;We need express passage to

the 10th floor.â&#x20AC;?

We could actually talk with each other to solve problems of competing needs such as when the uncomfortable patient and the team responding to a code are calling the same elevator. This might be a time to crowd together a bit more and make the extra stop. Change the message of signs posted in elevators from time to time to keep it fresh and put a new spin on the old concept of â&#x20AC;&#x153;elevator thoughtsâ&#x20AC;? (what you reviewed in your head as you responded to a call to see a patient with a problem). â&#x20AC;&#x153;Remember how nice it is for patients to be delivered a hot meal.â&#x20AC;? â&#x20AC;&#x153;Make room for

our doctors who are putting in long hours of service to our patients throughout the hospital.â&#x20AC;? â&#x20AC;&#x153;Patients appreciate quiet in the elevators.â&#x20AC;? â&#x20AC;&#x153;Our maintenance staff shoulders a heavy load to make our environment pleasant and clean.â&#x20AC;? â&#x20AC;&#x153;Together, we can make this a kinder, healthier and more efficient place to work.â&#x20AC;?

Elevate us. â&#x20AC;&#x201D;Dr. Kosinskii is an assistant professor of surgery in the Division of Colorectal Surgery at the Medical College of Wisconsin, Milwaukee.

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Three Perioperative Interventions Do Not Affect Quality of Life B Y M ANDY A RMITAGE , MD SAN FRANCISCO—The administration of steroids in the perioperative period, tight glucose control during surgery and light anesthesia do not affect patient quality of life measured at 30 days after major noncardiac surgery, a new study shows.

Although previous studies have found an association between steroids and improved quality of life (QoL) after

cardiac surgery, results of the DeLiT (Dexamethasone, Light Anaesthesia, and Tight Glucose Control) randomized controlled trial failed to support those results.

Also of note, this is the first and only randomized trial to date to study tight versus conventional glucose control in noncardiac surgery patients.

“Initially, investigators were under the impression that tight glucose control is beneficial,” said Basem Abdelmalak, MD, associate professor of anesthesiology and

director of anesthesia for bronchoscopic surgery at Cleveland Clinic in Ohio.

“Dexamethasone is currently being used for postoperative nausea and vomiting prophylaxis, or to help decrease airway edema in airway surgery.” However, this study did not show either intervention to be beneficial. Dr. Abdelmalak presented the results of his team’s study at the 2013 annual meeting of the American Society of Anesthesiologists.

Previous work indicates that high-dose

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steroids improve QoL after cardiac surgery; it also indicates that intensive glucose control reduces sepsis and improves mortality outcomes in some patient populations, according to the researchers.

Anesthesia guided by bispectral index monitoring (BIS; Covidien) reportedly speeds recovery and reduces respiratory complications as well as nausea and vomiting. The investigators thus expected to demonstrate beneficial effects of each tested intervention, Dr. Abdelmalak said.

The study consisted of 326 patients scheduled for noncardiac surgery under general anesthesia. They were randomized to receive 14 mg of IV dexamethasone tapered over three days versus placebo, intensive versus conventional glucose control (blood sugar goal of 80-110 mg/dL vs. 180-200 mg/dL g ), and light (BIS target, 55) versus deep anesthesia (BIS target, 35).

The researchers assessed QoL using the SF-12v2 Health Survey, a shorter version of the SF-36v2, obtaining scores preoperatively and 30 days after surgery. The researchers evaluated the effect of each intervention on physical and mental components of the survey.

After adjusting for minor differences in baseline ASA physical status, type of surgery and history of congestive heart failure and coronary artery disease, the researchers found no difference for any intervention in physical or mental SF-12v2 scores 30 days after surgery (P>0.4 for all).

Quality of life was a secondary outcome for DeLiT. The recently published primary results of the study, based on a composite of serious complications, showed no significant effect on perioperative morbidity from any of the three treatments.

“Given that none of the interventions influenced the primary outcome, it is perhaps unsurprising that there was also no effect on quality of life. It remains possible, though, that a larger dose of steroid may yet prove effective,” said Daniel I. Sessler, MD, the senior investigator on the study and director of outcomes research at the institution.

“There is increasing interest in quality of life as a primary or secondary end point in large perioperative trials, as researchers realize that survival is not the only outcome that is valued by patients and their carers,” said Kate Leslie, professor and head of Anaesthesia Research at the Royal Melbourne Hospital in Melbourne, Australia. “The investigators tested three perioperative interventions with the potential to improve quality of life after surgery.

Although none were shown to improve quality of life, these data provide a suitable basis for further study of different doses of dexamethasone and other anti-inflammatory treatments.”

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Dear Reader, Welcome to the February issue of The Surgeons’ Lounge. In this issue, William Frank Oppat, MD, FACS, program director of Vascular Surgery, Wayne State University School of Medicine, Providence Hospital and Mediccal Centers, Novi, Mich., discusses the case of a prregnant woman who presented with frank ischemia and loss of motor and sensory functions of the left lower exttremity.

Also, check out the reply to January’s challenge b below. l How did you do?

In “History and Other Facts,” we bring you a story about Joseph Edward Murray, a pioneer in organ transplant surgery, written by Yaniv Cozacov, MD, PGY-1, Department of General Surgery, Providence Hospital and Medical Centers, Novi, Mich.

Readers’ feedback is our greatest asset. Tell us how we’re doing! What do you want to see more of? Less of?

What is the best part of The Surgeons’ Lounge?? What can we do even better?

We look forward to your feedback!

Sincerely, Samuel Szomstein, MD, FACS Editor, The Surgeons’ Lounge Szomsts@ccf.org Dr. Szomstein n is associate director, Bariatric Institute, Section of Minimally Invasive Surgery, Department of General and Vascular Surgery, Cleveland Clinic Florida, Weston.

S Surgeon’s g ’ Ch Challenge ll g

from January 2014 201 Issue

Submitted by Shadi Al-Bahri, MD, and David V. Nasrallah, MD, FACS, Department of Surgery, Union Memorial Hospital, Baltimore, Maryland

A 27-year-old man presented to the emergency department with a week-long history of abdominal pain, readmitted with worsening symptoms, associated with fever and loss of appetite. His medical history was not significant except for recent travel to Mexico and Canada, and a questionable diagnosis of Crohn’s disease. An abdominal CT scan performed a week before this presentation showed thickened

small bowel loops in the right lower quadrant consistent with Crohn’s disease. His repeat CT scan on this presentation (Figure), however, revealed pneumoperitoneum consistent with a perforated viscus as well as a more pronounced circumferential small bowel wall thickening of the distal ileum. At that time, his white blood cell count was elevated at 12,400/mL, and his abdominal examination revealed a rigid abdomen with rebound tenderness, localized to the midline below the umbilicus. The above findings were concerning

Figure 1. The patient’s repeat scan revealed pneumoperitoneum consistent with a perforated viscus as well as a more pronounced circumferential small bowel wall thickening of the distal ileum.

for perforated small bowel, and therefore the patient was taken emergently to the operating room.

What is the diagnosis?

A. Perforated appendicitis B. Crohn’s disease C. Foreign body D. Carcinoid tumor continued ON page 20

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continued FROM page 19

Reply to Challenge A perforation was found along the thickened small bowel around 3 feet from the ileocecal valve, along with a pelvic abscess that had formed. The involved thickened small bowel was resected and an end-to-end anastomosis was performed. A foreign body was found in the small bowel wall, and was described by the pathologist as an acute small bowel ulcer with perforation caused by a plastic foreign body measuring 2.3 cm × 2.0 cm with a

Question for William Frank Oppat, MD

thickness of 0.1 cm embedded within the small bowel wall. This object is commonly known as the “bread clip” used in storage of presliced bread in plastic packaging (Figure 2).

Surgical removal of foreign bodies is usually unnecessary, because most ingested foreign bodies pass spontaneously. However, as many as

Figure 2. Foreign body: bread clip.

Dr. Oppat's

Reply

Yaniv Cozacov, MD, PGY-1, Department of General Surgery, Providence Hospital and Medical Centers, Novi, Michigan

A

30-year-old woman, eight weeks pregnant, had a 12-hour history of low back pain. She presented to the emergency room with frank ischemia and loss of motor and sensory functions of the left lower extremity, which started two hours before her arrival. Also notable were absent pulses, and gross motor and sensory deficits.

The patient’s left leg was remarkable for edema and cyanotic discoloration (Figure 1), and she was diagnosed immediately with phlegmasia cerulea dolens. Intraoperative duplex ultrasonography revealed that both common femoral and external iliac veins were markedly dilated and incompressible, consistent with acute thrombosis. The left popliteal and tibial veins also were dilated and incompressible, suggesting extensive iliofemoral thrombosis.

Mechanical and chemical thrombolysis for acute iliofemoral deep vein thrombosis (DVT) is becoming an increasingly used procedure for the treatment of acute proximal deep vein thrombosis, despite the relatively weak Fi Figure 11. Th The patient’s ti t’ lleg was evidence for its utility. remarkable for edema and (See guidelines in Chest cyanotic discoloration.

2012;141(2 Suppl): e419Se94S.) Is this a strategy for the management of proximal DVT that shows promise and that should be readily available at most institutions?

When have you found mechanical and chemical thrombolysis to be effective in the management of acute iliofemoral DVT? Which patients with acute proximal DVT are not candidates for mechanical and chemical thrombolysis for the management of DVT? What is the role of an IVC (or inferior vena cava) filter during treatment for iliofemoral DVT? Which long-term management strategies are important after therapy for a proximal DVT?

1 10% to 20% require endosscopic removal, and only 11% would require surgical iintervention. The latter was tthe case in this patient, as he presented with a small h bowel perforation along b with obstruction, which w rrequired surgical resection of the affected portion of small bowel.

With the recognition that DVT is a serious complication of hospitalization (whether it be on a medical or surgical service), coupled with the emphasis on prophylaxis (both mechanical and pharmacologic), great strides have been made to reduce the complications related to deep vein thrombosis. However, there are a number of instances in which patients still develop DVT. Hypercoagulability, the resection of pelvic tumors and pelvic radiation, long orthopedic procedures and posterior hardware from spinal fusions have been common precipitating events in our practice.

It appears that the most serious of DVTs involves the pelvic vessels and inferior vena cava (proximal DVT), not only because of the risk for pulmonary embolization, but also because of the venous insufficiency that leads to the development of the post-thrombotic syndrome. In reality, much of the effort of a general vascular surgical practice or a wound care clinic center focuses on the management of venous stasis ulcers and chronic edema, which undoubtedly result from venous complications. The burden of the cost for the management of the complications of venous insufficiency is thought to substantially outweigh arterial insufficiency.

The increased clinical awareness of DVT, more effective medical management, and our ability to diagnose this clinical problem by screening venous duplex has led to better short-term management. Compared with DVTs, which involve the femoral and popliteal venous segments, proximal DVTs are felt to be more likely related to fatal pulmonary embolism and the development of post-thrombotic syndrome.

Open mechanical thrombectomy for proximal DVT has fallen out of favor, given the blood loss, complications, and the lack of consistent success in the long term in preventing the sequelae of the post-thrombotic syndrome. However, vascular

surgical skills in the use of catheter and wire therapy developed from arterial disease treatment, combined with more effective mechanical therapy and thrombolytics, has led to a number of protocols that appear to be very successful in the clearance of DVT from the iliofemoral venous vessels, especially if the thrombus is acute in nature. Furthermore, clearance of thrombus from the iliofemoral vessels generally will reveal a venous obstruction that is successfully managed with effective angioplasty and stenting techniques. At our institution, we have access to an operating room well equipped with excellent imaging equipment, effectively making it a “hybrid room” where both open surgical procedures and catheter and wire techniques can be combined for more successful long-term outcomes. Technologies, such as intravascular ultrasound, document the effectiveness of thrombus clearance and should be used if available (Figure 2).

Fi Figure 2.

2 Use U off combination bi ti off open thrombus th b extraction and iliofemoral venous thrombectomy with venous angioplasty.

Given the risks associated with the use of thrombolytic agents, we have been hesitant to use mechanical and chemical thrombolysis in patients whose risk for bleeding complications outweighs any benefit from clearance of thrombus from within the iliofemoral veins. A clear example of a contraindication would be a patient with a recent craniotomy or spinal manipulation such that the development of a hematoma would result in permanent neurologic deficits. Each case must be evaluated to identify potential complications, and the risks and benefits must be discussed at length with the patient before proceeding with treatment.

Fortunately, in our series, bleeding complications

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History and Other Facts Joseph Edward Murray, MD (1919-2012)

Joseph Edward Murray: Pioneer in Kidney Transplantation B Y Y ANIV C OZACOV , MD, PGY-1 Edward Murray, MD, was born Joseph on April 1, 1919, in Milford, Mass.

While in high school, Murray became fascinated by the periodic table of the elements and said the “order of the universe” seemed miraculous. He claimed that this was the cause of his interest in

have been rare and were mainly related to access sites. One patient developed a hematoma in the calf that required surgical drainage after the posterior tibial vein was used for venous access.

Despite the availability of retrievable IVC filters, we have been reluctant to use them when performing iliofemoral mechanical and chemical thrombolysis unless the IVC is involved. The mechanical devices available for dissolution of the thrombus use a balloon at the distal tip that can be wedged at the origin of the common iliac vein. This balloon appears to be effective at preventing a large thrombus from embolizing from the iliofemoral veins to the lungs. If there is any suspicion that the thrombus has the ability to migrate proximally, an IVC filter should be used.

After successful mechanical and chemical thrombolysis, patients are initiated on systemic anticoagulation. The systemic anticoagulation is maintained for at least six months. In patients who appear hypercoagulable or who have a contraindication to systemic anticoagulation, we have used arterial venous fistulae created in the groin to further facilitate maintenance of patency of the iliofemoral vein and to assist in the continued clearance of the thrombus. Patients with defined hypercoagulability are treated lifelong with systemic anticoagulation unless the cause of the hypercoagulable syndrome can be reversed, such as in patients with pregnancy, oral contraceptive use or carcinomas resected for cure.

A number of randomized studies are currently under way assessing the longterm benefit of aggressive management of iliofemoral DVT. We expect that the outcome of these clinical studies will solidify the role of aggressive proximal DVT management in the future. To date, few studies indicate any long-term benefit of treatment of femoral–popliteal DVT with these techniques, and treatment of these patients should be avoided unless under protocol or when the limb is threatened.

the natural sciences. In college at Holy Cross, Murray studied subjects unrelated to medicine or basic sciences, believing that he would have enough time to devote to these in medical school.

After completing his surgical internship at the Peter Bent Brigham Hospital (now Brigham and Women’s Hospital) in Boston, with the rank of

First Lieutenant in the U.S. Army, he was assigned to Valley Forge General Hospital in Pennsylvania, while he waited for an assignment overseas. He later returned to Peter Bent Brigham Hospital as a faculty member after a short period in private practice. In 1986, a stroke ended his career in plastic surgery.

Murray performed the first successful

Save the Date!

human kidney transplantation between two identical twins in 1954, He was 35 years old at the time. Murray also performed the first dizygotic twin kidney transplantation in 1959, the first living unrelated kidney transplantation in 1961 and the continued ON page 22

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continued FROM page 21

first cadaveric unrelated kidney transplantation in 1962.

Although known for his work in transplantation, Murray is quoted as saying, “At heart, I’m a reconstructive surgeon,” and he considered plastic surgery as his true calling, especially facial reconstruction in children disfigured by cancer or birth defects. According to Francis Moore, MD, who at the time was surgeon-in-chief at Brigham, “Joe’s the only guy who ever won a Nobel Prize for pursuing a hobby.”

Murray received the Nobel Prize in Physiology or Medicine in 1990, “for discoveries concerning organ transplantation in the treatment of human disease.” He shared the award with E. Donnall Thomas, the first person to transfuse bone marrow for the treatment of leukemia and diminishing the “graft-versus-host” reaction by using methotrexate.

With Alexis Carrel’s breakthrough in vascular anastomosis and organ transplantation advances, it was Murray who fulfilled a long-awaited dream of curing patients with such medicine. Carrel, a French surgeon and biologist, managed to harvest a kidney from a dog and reimplant it in that same dog, with the organ maintaining its function. Problems arose, however, when Carrel tried to harvest the

kidney from one dog to transplant it in another, with the organ soon necrotizing and losing its viability. Carrel divided human organ transplantation into two major aspects: the technical part, in which he succeeded, and a second part that he described as a “biological force,” later referred to as the “immunological barrier.”

Murray became interested in the biology of graft rejection when Charles Woods, an army pilot, experienced a plane crash during taxi. Although sus- Fi Figure 11. Th The H Herrick i k brothers b th in i front f t off the th taining severe burns of over 70% of his Peter Bent Brigham Hospital in Boston. body, Woods survived the crash and arrived at Valley Forge General Hospiidea further to explore the possibilities of tal, where Murray was stationed. The only bypassing the immunologic problem. chance of saving Woods’ life was to graft James Barrett Brown, MD, chief of skin from another person, because there plastic surgery at Valley Forge Generwere not enough sites for autotransplan- al Hospital, postulated that the clostation. Skin was grafted from a deceased er the genetic relationship between the soldier, and instead of the expected rejec- skin donor and the recipient, the slowtion within 10 to 14 days (certainly not er the dissolution of the graft. In 1937, enough time for Woods’ own skin to grow Dr. Brown cross–skin-grafted a pair of back), it took Woods’ body more than a identical twins and documented permamonth to reject the graft. Murray hypoth- nent graft survival in both twins. Murray esized that due to the morbid condition of pointed to this accomplishment, in part, the patient’s body, his immune system was for inspiring the beginning of his work, impaired, giving him just enough time to and stated that the achievement was like survive. This suggested to Murray that if a ray of light in the hope for understandthere was a way to actively manipulate and ing organ transplantation. suppress the immune system, organ rejecThe first successful transplant recipition could be prevented. He carried this ent was Richard Herrick, a 24-year-old

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twin who had chronic glomerulonephritis. He had an 18-month history of terminal-state renal disease resulting in the malignant hypertensive syndrome, which included severe hypertension, marked peripheral edema, encephalopathy, uremia and congestive heart failure.

Although Carrel had published his work indicating that grafts could survive for long periods of time, his research was not available to Murray or others, and no one was able to duplicate his work. Furthermore, although there was evidence that grafting between identical twins would not result in rejection (as shown

by Brown), there still were no assurances that the kidney would survive in such a case.

There was also the need to ensure beyond doubt that Richard and his brother Roland were, in fact, monozygotic twins (Figure 1). After preoperative testing, including blood grouping for 21 blood subgroup antigens, a geneticist concluded that the brothers were 98.5% identical twins (based on study of the configuration of their irises, ears and other data). To further remove doubt, cross–skin-grafting was performed. After 31 days, a biopsy confirmed that rejection had not occurred. After the biopsy, Richard was readmitted in severe distress with retinal hemorrhages and exudates,

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marked cardiomegaly, and peripheral and pulmonary edema. His renal disease was brought under control with medications and dialysis, and six days later, after his biopsy showed no rejection, the transplantation was performed (Figure 2).

About three years after the transplantation, Richard Herrick was reported to be living well with normal blood pressure and normal cardiac and renal functions. He married the nurse who tended to him in the hospital, and he became a father. His transplanted kidney functioned for eight years, until the diffuse chronic glomerulonephritis recurred.

Murray stated: “We had achieved our long-term goal by bypassing, but not solving, the issue of biological incompatibility.” The next step in renal transplantation would be directly manipulating the immune system, and not “bypassing” it, which would serve only in cases of identical twins. Murray developed a reproducible operation using intra-abdominal vascular anastomoses and an ureterocystostomy that became the universal renal transplantation procedure.

In March 1961, azathioprine was used for the first time in a kidney transplantation from an unrelated donor (Figure 3). The patient died from the drug’s toxic effects, but the kidney had functioned for more than a month, creating much hope.

A second patient also died from complications arising from azathioprine’s side effects. A third patient, Mel Doucette, aged 23 years, underwent kidney transplantation with azathioprine in April 1962. He received a cadaveric graft and survived for more than a year, becoming the world’s first successful unrelated renal allograft patient. Soon after this success, corticosteroids were added for a synergistic effect with the azathioprine treatment.

After this, transplantation programs were established around the world.

In the mid-1950s, only one in 12 transplanted kidneys were viable at three months; by 1965, the one-year survival rate had improved to an incredible 80%.

In 1966, direct cross-matching between donor lymphocytes and recipient’s serum was introduced, and this nearly eliminated the hyperacute rejection type due to preformed antidonor antibodies. By the time Murray received the Nobel Prize, it was estimated that more than 200,000 renal transplants were performed in humans worldwide.

Harvesting a healthy organ from a healthy donor raised an ethical dilemma, however. It took Murray two years to gain the medical community’s approval, and some opposition continued after this. Friends and colleagues warned Murray that he could ruin his career, and many skeptics thought transplantations were impossible and years away from viability. Murray’s response to them: “Even

Fi Figure 2.

2 Th The fi firstt successful f l kidney kid transt plantation, taking place in 1954.

more troubling is the fact that patients in end-stage renal failure were dying with no cure available.”

Murray is quoted as saying, “In the course of many laboratory experiments on canine renal transplantation, a reproducible operation was developed that became the universal transplant procedure since that time.” It was the reproducibility of the procedure that captured the Nobel Prize.

One of the great lessons learned from Murray is that research and clinical work should be practiced together.

This was a recurring motif in Murray’s

published work and when he gave talks.

Murray wrote: “It is absolutely essential for medical progress that dedicated clinical surgeons and scientists understand and work with scientists of other basic disciplines. It is a simple fact that basic scientists cannot be surgeons, so it is essential that surgeons be scientists.”

Along with that, he also said: “There is only one science, basic science and clinical, and they are locked together like the trunk of a tree to the branches. They are all forms of seeking knowledge. Clinicians have problems to solve that researchers in a lab never see.”

Rationale, Reversal, and Recovery of Neuromuscular Blockade Part 1: Framing the Issues Case Study Harold is a 74-year-old man undergoing a video-assisted right upper lobectomy for stage I non-small cell lung cancer.

Current Symptoms • Dyspnea • Coughing with hemoptysis • Chest pain Vital Signs • Height: 177.8 cm (70”) • Weight: 65 kg (143 lb) Signi¿cant Medical History • Hypertension • Chronic obstructive pulmonary disease (moderate) Current Medications • Metoprolol succinate ER 50 mg/d • Tiotropium bromide inhalation powder Laboratory Results • 2-cm lesion in right upper lobe revealed on chest computed tomography (CT) scan; malignancy con¿rmed with needle biopsy • No abnormal bronchopulmonary or mediastinal lymph nodes; brain CT, isotopic bone scan, abdominal ultrasonography negative for distant metastases • Forced expiratory volume in the ¿rst second: 43.6% of predicted value (1.44 L) • Carbon monoxide diffusing capacity: 71.7% of predicted values (20.19 mL/min/mmHg) • 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 sponsored by Global Education Group and Applied Clinical Education.

Supported by an educational grant from Merck.

Applied Clinical Education is pleased to introduce a new interactive 3-part CME series featuring challenging cases in neuromuscular blockade.

Each activity will present a clinical scenario that you face in your daily practice. After reading the introduction to the case, consider the challenge questions, and then visit www.CMEZone.com/nmb1 to ¿nd out how your answers stack up against those of our multidisciplinary faculty panel.

Access the activities on your desktop, laptop, or tablet to explore the issues surrounding safe, effective, neuromuscular blockade and reversal via a unique multimedia learning experience and earn 1.0 AMA PRA Category 1 Credit.™ Participate in the coming months as well to complete the whole series and earn a total of 3.0 AMA PRA Category 1 Credits.™ This activity’s distinguished faculty Jon Gould, MD Glenn S. Murphy, MD Chief, Division of General Surgery Alonzo P. Walker Chair in Surgery Associate Professor of Surgery Medical College of Wisconsin Senior Medical Director of Clinical Affairs Froedtert Hospital Milwaukee, Wisconsin

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

Challenge Questions 1. What would you do next?

2. What potential postoperative risks does this patient face?

Access this activity at www.cmezone.com/nmb1

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