July 2015 by McMahon Group

GENERALSURGERYNEWS.COM

July 2015 • Volume 42 • Number 7

The Independent Monthly Newspaper for the General Surgeon

Opinion

Surgeons Tackle Chronic Pain at World Hernia Meeting

Put Down the Gun, Pick Up A Scalpel B Y D AVID H. R OTHSTEIN , MD, MS, M AMTA S WAROOP , MD

AND

illboards and online applications enable many patients in the United States to choose an emergency room based on waiting times. An hour and a half sounds too long? Maybe the shiny new emergency department down the road can get you seen in 45 minutes. What if the waiting time was a day? Or a week? Or what if you could neverr see a nurse or a doctor? This is the problem facced by a majority of the world’s population, parw tticularly when it comes too surgical care. The numbers are staggering. An estimated 5 billi billion people l currently lack access to safe and timely surgical care. Of the estimated 235 million operations performed each year across the world, only 4% take place in poorer countries, where 35% of the world’s population lives. The muchanticipated recent World Bank publication of the first volume of the “Disease Control Priorities” (3rd edition), entitled “Essential Surgery,” has taken the surgery

B Y V ICTORIA S TERN

Preventng Retained Surgical Sponges: Clinical and Economic Considerations see insert after page 24

see BLACK BOX page 10

see HERNIA PAIN page 8

A Rives retrorectus repair with a transversus abdominis release, done robotically. Image courtesy of Alfredo Carbonell, DO.

Surgeons Abuzz Over New Robotic Hernia Technique Surgeon Performs Live Robotic TAR to Captive Crowd B Y C HRISTINA F RANGOU NEW YORK K—This spring, via a feed from his hospital in Greenville, S.C., to a jam-packed room at the Marriott Marquis in Manhattan, Alfredo M. Carbonell, DO, performed the

world’s first live robotic transversus abdominis release (TAR) procedure. For surgeons in the audience, the surgery was the highlight of the twoday inaugural Global Symposium on Robotic-assisted and Minimally see ROBOT FOR HERNIA page 14

A ‘Black Box’ for the O.R. Borrowed From Aviation, a Tool for Learning, Not Fault-Finding B Y C HRISTINA F RANGOU

see WORLD SURGERY page 18

REPORT

and make it easy to identify when and how surgeons make errors? Such a black box, the first of its kind in the world, has been put into action at St. Michael’s Hospital, in

MILAN—Chronic groin pain after hernia surgery is now considered the most important issue facing inguinal hernia surgeons and their patients. Yet, there is still much uncertainty surrounding what causes the pain and how to prevent it. Although pain estimates vary considerably, on average, studies reveal that approximately 10% to 12% of patients report moderate to severe chronic pain after inguinal hernia repair, with about 0.5% to 6% experiencing pain so severe that it affects their daily activities (J ( Pain Ress 2014;7:277-290). Given that an estimated 20 million inguinal hernia repairs are performed annually around the world—800,000 of which occur in the United States—even 0.5% represents a robust patient group (1 million worldwide, 40,000 in the United States). At the World Hernia Conference in Milan, surgeons discussed the pain landscape, from current insights and gaps in our understanding of pain to potential treatments and preventive measures. Gérard Champault, MD, a general surgeon from France, gave an overview of pain in inguinal hernia repair. After scanning the literature, Dr. Champault concluded that overall studies show less pain after laparoscopic repair compared with open repair, mesh repair compared with non-mesh repair, lightweight mesh

NASHVILLE, TENN.—The idea has been debated for years by surgeons, with equal parts dread and anticipation: What if there was a “black box” for the operating room that could record every aspect of an operation

INSIDE In the News

Surgeons’ Lounge

Video

Ablation System May Double Survival in Stage 3 Pancreatic Cancer

Expert Answers Questions About Transverse Abdominis Release from the International Hernia Collaborative Group

The Aging Surgeon: A Minisymposium from Cedars-Sinai Medical Center. See page 22 for more information and visit generalsurgerynews.com to view the video.

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

According to us, the answer is no. But each new device takes us closer. Zenapro, for instance, is the first hybrid hernia-repair device. A sheet of ultra-lightweight polypropylene mesh surrounded by extracellular matrix, Zenapro gives patients a permanent repair while leaving behind minimal foreign material in the body. Learn more: visit zenapro.cookmedical.com. Zenapro Hybrid Hernia Repair Device â&#x201E;˘

www.cookmedical.com ÂŠ COOK 11/2014 D15408-EN-F

GSN Editorial

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / JULY 2015

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

ince the late 1970s, when studies began appearing linking volume of surgical procedures to outcomes, the quiet discussion in hospital credentialing committees has centered on whether privileging to perform certain operations should be tied to surgical volume. Now, that discussion is out in the open, as three major health care institutions—Dartmouth-Hitchcock Medical Center, Johns Hopkins Medicine and the University of Michigan Health Sysytem—have announced plans to impose minimum standards in their hospital systems that would preclude the performance of certain operative procedures based on volume. The basis for this strategy is that surgeons who perform below-minimum numbers of certain operations have worse outcomes and create more overall risk for their patients. Initially, this process will be “voluntary,” with minimum metrics agreed upon that would cover certain

orthopedic (joint replacement), cardiac and general surgery procedures. Minimum numbers for the hospital and the individual surgeon have been promulgated by these academic systems: as examples, a minimum of 40 and 20 bariatric procedures for the hospital and the individual surgeon, respectively; 20 and five for esophageal procedures; 20 and five for pancreatic procedures; 15 and six for rectal cases; and 40 and 20 for resection of lung cancer. What if a surgeon does 28 bariatric procedures in a year, but his or her hospital has only 35 total bariatric cases? What a conundrum! Obviously, the list of restricted procedures will get longer. These voluntary standards, which are expected to go into effect before the end of 2015, represent the first coordinated effort to place limits on hospitals and surgeons, who traditionally have been allowed to perform virtually every procedure within the scope of their specialty training, even if only once a year. It is not surprising that organizations such as the Leapfrog Group, which has championed using surgical volume as a surrogate for advancing hospital safety, is behind the restriction of surgeon privileges and exclusion of hospital case-specific

care based on annual operaative occurrences. Others have not been so fast to join the bandwagoon. Two flagship Harvard Un niversity teaching hospitals in the Partners Healthcare system—MassaM chusetts General Hospital and Brigham and Women’s Hospital—and their sister institutions in the system say they are considering the new standards, but are not ready to sign on without considerably more deliberation. I applaud this approach because the “one size fits all” strategy has been proven to be detrimental in other scenarios. The universal imposition by the Accreditation Council for Graduate Medical Education of the 80-hour workweek limitations for all residency programs comes to mind! Clearly, any decision to limit the ability of surgeons to carry out certain operations must be based on the assessment of appropriate outcome measurements, both for the individual and his or her hospital. Outcomes must be risk-adjusted since we have also seen knee-jerk responses in the past when comorbidities, disparities and other risks are not taken into consideration. That said, we now have clear data

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th hat support the performance of procedures for m paancreatic and esophageaal cancer at high-volume centers and show that survivaal is improved when both b h the h h hospital and the clinicians (not just the surgeon) have considerable experience with these malignancies. I am all for the improvement of surgical outcomes using appropriate metrics. Volume is only one of many metrics that has been applied to surgical outcome analysis. Although it is true that we have been analyzing outcomes using surgical and hospital volumes over the past several decades, I am wary of the application of volume metrics as the sole limiting factor in surgical credentialing. If we take the tactic of limiting community hospitals in their opportunity to perform certain procedures, we deprive good and capable surgeons working in those facilities of honing their skills and attaining excellence. This same philosophy applies to both the community hospital and the large academic institution with its affiliates. I continue to be in favor of raising the standards for all versus curtailing opportunities for some.

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In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / JULY 2015

Arnold Salzberg, HB, MD: The Pied Piper of MCV BY DAN W. PARRISH, MD, JEFFREY H. HAYNES, MD, AND CHARLES E. BAGWELL, MD [The following is an excerpted and edited article that was originally published in the Journal of Pediatric Surgery (2015;50:211-217). The full article can be found at www.generalsurgerynews.com.] Salzbergian \solz-bərgē-ən\ adjective of, relating to, or following the teachings of Arnold Salzberg. Noun one who embodies all that Arnold Salzberg taught about humanity. Noun one who has obtained his or her HB degree.

ebster’s Dictionary would probably define “Salzbergian” as one who trained under Arnold Salzberg and exhibits the same great character traits, mentoring ability and surgical skills. These might be the words that are used, but many times words cannot do justice to something so special. Arnold Salzberg was many things to many different people—“father figure, “wonderful advisor and resource,” “ultimate mentor,” “humanitarian”—but when he was asked how he wanted to be remembered, he simply smiled and replied, “Icon … that would be nice.” Never at a loss for words or humor and forever with an open door to his office, home and heart, Dr. Salzberg embodied what so many medical students, residents and attendings have been striving for: the ideal combination of physician and human being. To be able to accomplish one aspect of his professional life would have made him a legend in the field of surgery. Bringing extracorporeal membrane oxygenation (ECMO) to the Medical College of Virginia (MCV), being the only pediatric surgeon in the community for more than 30 years, authoring more than 150 articles and chapters, and advancing the field of pediatric surgery and oncology would be enough for most people. Influencing nearly 20 medical students and residents to pursue pediatric surgery and become leaders in the field would also have been enough for most people. But Arnold Salzberg wasn’t most people. Even in his final days, he was influencing those he had mentored and still reminding them of what he had made them want to accomplish: not only pediatric surgery, but greatness. Many times during the writing of this paper, stories were told in the first person only for the teller of the story to realize that he hadn’t been there in the first place. The stories are recalled and told so vividly over and over, and his phrases and quotes continue to be spoken and passed

along like lines from our favorite movies, that those of us who never worked with or even knew Dr. Salzberg feel like we could be one of his students. By continuing to tell his stories and influencing those below them to pursue the same greatness for which Dr. Salzberg pushed, his “disciples” are continuing his tradition and continuing to demonstrate what it means to be Salzbergians.

The Beginning Paterson, N.J., is known for many things: Larry Doby, the first black baseball player in MLB American League; “Paterson,” an award-winning poem by William Carlos Williams; Joseph Pistone, an FBI agent portrayed in “Donnie Brasco”; and Lou Costello, actor and comedian. On May 21, 1922, Paterson became home to one of the pioneers of pediatric surgery, Arnold Martin Salzberg. Arnold Salzberg, or Arnie, was the son of Harry and Elsie Salzberg. His father was a Polish immigrant who settled on New York City’s East Side with little to no resources. His father pushed a garment cart in the city and, with his brother, earned enough money to purchase a textile factory. Like most young men at the time, he planned to follow in his father’s footsteps with a career in the textile business. When he began his undergraduate studies at the University of North Carolina (UNC) at Chapel Hill, the plan was to major in business. However, believing that medicine would be a more lucrative and sustainable profession than the ever-changing and competitive world of the textile industry, his parents encouraged him to obtain a medical degree. Arnold followed his parents’ advice and pursued his premedical education at the University of North Carolina from 1939 to 1942, before continuing his medical education at New York Medical College. In

addition to obtaining his degree, he lettered on a UNC tennis team that went undefeated in his senior season. From 1942 to 1945, Arnold trained at New York Medical College, including training in the Army Student Training Program as a private first class during 1943-1945. After medical school, he did an internship at Paterson General Hospital before serving as a lieutenant and captain in the Army Medical Corps from 1946 to 1948. He moved to Richmond, Va., to begin his general surgery residency at MCV in 1948. He completed his residency in 1953, a thoracic surgery fellowship at George Washington University Hospital in Washington, D.C., in 1954, and a pediatric surgery fellowship at Boston Children’s Hospital in 1955. After completion of these fellowships, Dr. Salzberg returned to MCV as an associate in surgery in 1955. Following this appointment, he completed a second pediatric surgery fellowship at Babies Hospital at Columbia University, in New York City, in 1960, under the tutelage of Dr. Thomas Santulli, before returning to MCV as an assistant professor of surgery in pediatric and thoracic surgery. He rose through the academic ranks and became the chairman of the Division of Pediatric Surgery in 1967, and a professor in 1970. After a brief surgical practice in San Diego, Dr. Salzberg returned to MCV in 1973, because “it was where his heart remained.” When he arrived home, he picked up right where he left off, leading the Division of Pediatric Surgery, working tirelessly for his patients, and mentoring his students and residents. Dr. Salzberg was one of the first 50 American physicians to specialize in pediatric surgery, and his desire to practice pediatric surgery stemmed from wanting to help children move forward to a full and long life. Children seemed to recognize

Arnold Salzberg’s senior portrait in the UNC Yearbook, 1942. his fondness and caring nature and were not afraid. “He had a gentle touch and a smile that always radiated trust and comfort,” his wife, Cora, said. “In addition, he had great compassion for patients and families who were in distress.” Besides his patients, whom he often referred to as “his kids,” he had many other children. Some were his own, including Harry, Bambi and David, and some were his students and residents. “He always referred to them as ‘my kids’ and ‘my family,’” Cora said. At home, he was a great dad to his children, often making snacks for them while engaging them in discussions about their interests and goals. He took on each of their hobbies in an attempt to connect to them. He even went so far as to buy the same textbooks that they were using in school, so he could study and keep up with their schoolwork to help them if they needed it. His son, David, followed in his footsteps and trained in general surgery at MCV. Often when his wife returned home from work, there would be “one of [his] children” there, discussing an issue from the hospital or life. They would stay for dinner and “would retire to the sun porch for discussions, which resulted in solutions to the student’s problems.” Dr. Salzberg’s office and home were gathering places for students and colleagues to work their way through issues.

There are only 2 things wrong with you: DNA and RNA

University of North Carolina tennis team, 1942.

Although Dr. Salzberg was a caring, all-knowing man, he would not accept if you were not doing your best. “Arnie had a way of berating you with humor, while at the same time, making you feel appreciated and cared for,” said a former resident. If you were struggling with a certain step in an operation or with a question and said, “Dr. Salzberg, I’m doing the best I can,” he would quickly reply, “I know, that’s the pity of it!” or “don’t make it your life’s work” or “we could spend all dayy talking about what you don’t know” if “I don’t know” was your answer to one of his questions.

In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / JULY 2015

Although he pushed for excellence from his students, he always ensured that they were not stripped of their dignity and self-worth. He often noted that the students gave him more than he gave them because they kept him young, energetic and inquisitive. He took a genuine interest in every student he taught. They looked to him for personal and professional advice and guidance. Even former students who finished their training at MCV contacted or visited him to seek advice and guidance about professional and personal pursuits.

We’re having fun now His humor and desire to challenge were not allocated only to students and residents, as Dr. Charles Bagwell found out his first weekend after coming to MCV to succeed Dr. Salzberg as the division chair. “I walked in the front door to take over the department and learned that Arnie had left for a week’s vacation in the Bahamas,” said Dr. Bagwell.

Dr. Salzberg with his wife, Cora, and son, David.

He’s slow … but poor Although his excellence in the operating room and hospital were known, his athletic prowess gave him another chance to teach his residents lessons. He smoked cigars, used his inhaler, took medicine for chronic obstructive lung disease, and said about daily exercise, “Who needs it … why are you wasting your time,” but he could still hold his own on the tennis court. One of his residents who knew of his athletic history and was known as the best tennis player among the house staff would brutally taunt and chide Dr. Salzberg to get him to play a match with him. At an American Pediatric Surgery Association (APSA) conference at Marco Island, Fla., Arnie agreed to a match, and he “sauntered” off to the tennis court on a “brutally hot day.” The others in attendance were prepared to call an ambulance and begin administering CPR if needed. A couple of hours later, they returned from their match: “Arnie looked like he had never worked up a sweat, and his opponent looked like hee needed the rescue squad.”

Don’t make it your life’s work to duplicate something that’s already been done by someone else Not only did Dr. Salzberg continually inspire students and residents to be the best they could be, he inspired them to be great and to do things that others had not done. When Dr. Robert Bartlett came to MCV to discuss his developments with ECMO, Dr. Salzberg recognized the importance of this new tool and saw where it could benefit his patients. He sent one of his residents, who was entering the lab, to California to learn the technique and

Arnold M. Salzberg, HB, MD, 1922-1997. start an ECMO program at MCV. In addition to bringing ECMO to Richmond, he developed new techniques in the treatment of children’s cancer and lung disease and was instrumental in creating a neonatal intensive care unit.

Don’t be no hero “Dr. Salzberg would always give us enough rope to test and challenge ourselves but not enough to hang ourselves” is a sentiment shared by many of his former residents. He credited Drs. David Hume and Walter Lawrence for being his most meaningful mentors, and mentoring his residents and students became one of the primary goals of his life as a surgeon, and became the lasting impression that he would leave. He wanted his residents to realize their potential. “He knew what we were capable of before we ever did,” a former resident said. The focus and drive he gave to this task became his legacy. For those who chose to pursue pediatric surgery, Dr. Salzberg would accompany them to the American Academy of Pediatrics (AAP) and APSA meetings and introduce them to surgeons and program directors from across the country. “He would ‘hold court’ at these meetings the same way he did in the hospital.’” His mentoring did not stop because you had graduated or left MCV or hadn’t

chosen pediatric surgery. He was known to accompany those who were retaking their American Board of Surgery certifying examination, after failing to pass the first time. “He would cancel all that he had going on those days and travel with them, get a hotel room, take them out to dinner, and just be there for them so they knew they were not alone,” according to Dr. Bagwell. He was always known as a great teacher and mentor, and continually received recognition for his mentorship. He regularly received the “Faculty of the Year” award at MCV, and was honored in 1989 by the State Council for Higher Education in Virginia as one of the 10 best professors in the Commonwealth. He was considered the best teacher at MCV by the medical students, was inducted into the Alpha Omega Alpha Honor Society in 1995, and was named “Clinician of the Year” by his colleagues in 1996. “Human Being, the HB degree, as he called it—more important than an MD or a PhD, and far more difficult to achieve. Arnie showed his students how to achieve it, how to be a human being, with his life,” said a former student and resident. Dr. Salzberg came to MCV in 1948, and practiced as a resident and attending at MCV for nearly all of the next 50 years. He chaired the Division of Pediatric Surgery from 1973 to 1993, but after a

hard-fought battle with pancreatic cancer, he died on March 21, 1997. At his funeral, his pallbearers were all MCV graduates who had become pediatric surgeons, and during the funeral, they were seated with his family because that’s what Arnie considered them. After Dr. Salzberg’s death, it fell to his former residents and colleagues to ensure that his influence on everyone’s lives would be remembered. The American Academy of Pediatrics Section on Surgery created the Arnold M. Salzberg Mentorship Award, which “recognizes a pediatric surgeon who has distinguished him/herself as a mentor of pediatric surgical trainees.” The award is presented annually at the AAP National Conference (American Academy of Pediatrics. “Section on Surgery Awards.” American Academy of Pediatrics. 2011. Accessed on September 12, 2014. http:// www2.aap.org/sections/surgery/SOSuAwardsPage.pdf ). The Virginia State Senate introduced Joint Resolution No. 55 in 1998, which was presented to Dr. Salzberg’s family “as an expression of the deep and abiding respect in which his memory is held by the members of the General Assembly and the people of Virginia.” The Medical College of Virginia and Virginia Commonwealth University have established the Arnold M. Salzberg Professorship in Pediatric Surgery that allows “the recruitment and retention of a pediatric surgeon who exemplifies Arnold’s ideals in terms of patient care, teaching, and research into the cause, prevention, and treatment of pediatric surgical problems.” Dr. Salzberg’s legacy and influence can be seen and felt across the country. “There are many people in his mentoring tree, but it’s not the number that is impressive, but what they became.” His students and residents have become program directors, fellowship directors, chairmen of divisions, chairmen of departments, and so on. Although he is no longer with us, he continues to influence and will do so for generations to come. Thanks to everyone who contributed to this work: Cora Salzberg and Drs. Neifeld, Lawrence, Greenfield, Krummel, Olutoye, Drucker, Tracy, Langham, Nwomeh, Shochat, Adolph, Andrassy, Haynes, Mast, Alaish, Maurer and Bagwell [see online version of this article for their stories about Dr. Salzberg]. —Drs. Parrish, Hayness and Bagwell are — from the Department of Surgery, Virginia Commonwealth University, Richmond.

In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / JULY 2015

Ablation System May Double Survival in Stage 3 Pancreatic Cancer Excitement Tempered With Caution; Selected Patients B Y C HRISTINA F RANGOU

rreversible electroporation, an emerging ablative technique in cancer treatment, may prolong survival in patients with locally advanced pancreatic adenocarcinoma, with the latest survival rates nearly double those of historical

controls, according to a new study. In a study presented at the 2015 annual meeting of the American Surgical Association, surgeons reported that patients treated with irreversible electroporation (IRE), in addition to conventional chemotherapy and radiation therapy, survived for a median of 23 to 28 months after treatment. The survival rates are more than double those typically expected for patients with stage 3 pancreatic cancer. Most

previous studies put median survival for these patients at approximately 11 to 13 months if patients undergo treatment with conventional therapies, the investigators said. Five-year survival is less than 6%. “These results should emphasize to the greater medical and oncology community that stage 3 pancreatic cancer is a treatable disease and not an immediate death sentence. Clearly, durable overall survival can be obtained with Irreversible electroporation is an emerging technique that may prolong survival in selected pancreatic cancer patients. collaborative multidisciplinary care through the use of chemotherapy, IRE and chemoradiation therapy,” said lead author Robert C.G. Martin II, MD, PhD, director of surgical oncology and professor of surgery, University of Louisville, in Kentucky. Experts caution that the results come from a small number of institutions, and the study was not conducted in a randomized design with a valid comparison arm. Even so, there is great excitement in the oncology community about the prospect of an ablative technology that can be used with good results on locally advanced pancreatic cancer. Of the 40,000 people in the United States diagnosed with pancreatic cancer annually, only a minority are candidates for surgery. A suitable ablative technique could help control local disease in patients who are ineligible for surgical resection. The thermal ablative techniques used for other cancers, notably liver cancer, are not suitable for pancreatic disease because of widespread damage to tissues beyond the cancer cells. “What this technique does is offer you an alternative for local control without the morbidity or mortality of complex resection in the select group of patients who are responsive to chemotherapy and have not metastasized, and who have disease that’s amenable to ablation,” said Keith D. Lillemoe, MD, surgeon-in-chief at Massachusetts General Hospital and the W. Gerald Austen Professor of Surgery at Harvard Medical School, both in Boston. “It is a very select group of patients.” Dr. Lillemoe was not involved with the study and does not personally perform IRE. He does refer patients for the procedure within his institution. He called the results “encouraging,” but stressed the need for multicenter, randomized trials with long-term follow-up.

In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / JULY 2015

’These results should emphasize to the greater medical and oncology community that stage 3 pancreatic cancer is a treatable disease and not an immediate death sentence.’ —Robert C. G. Martin II, MD, PhD

“It would be great to be able to say definitively that [IRE] will add to survival. I don’t think we can do that yet, but I do think the door is open to the trials that can make that determination.” Approved by the FDA under a 510(k) clearance for ablation of soft tissue, IRE is an energy delivery system that ablates tumors by inducing irreversible cell membrane destruction (NanoKnife, Angiodynamics). Clinicians administer high-voltage, nanosecond electrical pulses directly to pathologic tissues by placing minimally invasive electrodes within the targeted region. The pulses damage the cell membrane porosity, leading to permanent cell death by apoptosis over six to eight weeks, but without causing further damage to surrounding vessels, nerves and neighboring normal tissue. The system was first reported for use in patients who had locally advanced pancreatic adenocarcinoma in 2009. This is the largest series to date of patients treated with this technology. In this study, 200 patients with locally advanced pancreatic adenocarcinoma underwent IRE between March 2010 and October 2014. At diagnosis, the cancer was defined as greater than 180-degree encasement of the superior mesenteric artery and/or celiac artery, unreconstructable venous involvement and no evidence of lesions suspicious for metastatic disease. All patients underwent chemotherapy or chemoradiation or both, according to each institution’s protocol. Approximately four to six weeks after completion of therapy, each patient underwent restaging with a repeat triple-phase computed tomography scan and serum tumor markers. Patients who were free of metastatic disease and did not have significant primary tumor progression were candidates for IRE. Fifty patients underwent pancreatic resection plus IRE for margin enhancement and 150 patients underwent IRE alone. All patients started with induction chemotherapy, and 52% received chemoradiation therapy for a median of six months (range, five to 13 months) before IRE. At a median follow-up of 29 months, six patients (3%) experienced a local recurrence. The progression-free interval to local recurrence was a median 10.7 months. One-fourth of patients experienced distant progression, mainly spread to the liver (17%). Median overall survival in the study was 24.9 months, and ranged

from 4.9 to 85 months. Complications occurred in 37% of the patients and were a median grade of 2. Eleven patients had vascular complications, including deep venous thrombosis, pseudoaneurysm, hepatic arterial thrombosis and nonocclusive super mesenteric

vein/portal vein thrombosis. Three patients died within the first 90 days; they had undergone IRE without resection. This procedure is only indicated in patients who can undergo general endotracheal anesthesia, the investigators noted. Dr. Martin recommended that surgeons offering IRE or referring patients for the treatment should work with the Americas Hepato-Pancreato-Biliary Association’s collaborative patient safety registry. Dr. Martin and his co-author, Sricharan Chalikonda, MD, disclosed that they are paid consultants for Angiodynamics.

Partial support of the Soft Tissue Ablation Registry came from an unrestricted education grant from Angiodynamics. This year marked the 135th annual meeting of the American Surgical Association. Established in 1880, the American Surgical Association is the oldest surgical association in the United States. The complete manuscript of this study and its presentation at the American Surgical Association’s 135th Annual Meeting, April 2015, in San Diego, Calif., is anticipated to be published in Annals of Surgery, pending editorial review.

Via-Guard

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͞/Ŷ ƚƌŝĂů ƵƐĞ ŝŶ ƚŚĞ ŽƉĞƌĂƟŶŐ ƌŽŽŵ͕ ƚŚĞ sŝĂͲ'ƵĂƌĚ ^ƵĐƟŽŶ ^Ğƚ ǁŽƌŬĞĚ ƉĞƌĨĞĐƚůǇ͘ ͘͘͘/ ĐĂŶŶŽƚ ŝŵĂŐŝŶĞ ǁŚǇ ĂŶǇŽŶĞ ǁŽƵůĚ ƵƐĞ ƚǁŽ ƐĞƉĂƌĂƚĞ ƐƵĐƟŽŶ ƟƉƐ ǁŚĞŶ ƚŚŝƐ ƉƌŽĚƵĐƚ ŝƐ ĂǀĂŝůĂďůĞ͘͟ James A. Greenberg, MD ƌŝŐŚĂŵ ĂŶĚ tŽŵĞŶ͛Ɛ ,ŽƐƉŝƚĂů͕ &ĂƵůŬŶĞƌ ,ŽƐƉŝƚĂů͕ ,ĂƌǀĂƌĚ DĞĚŝĐĂů ^ĐŚŽŽů͕ ŽƐƚŽŶ͕ D ΀ZĞǀŝĞǁƐ ŝŶ KďƐƚĞƚƌŝĐƐ Θ 'ǇŶĞĐŽůŽŐǇ͘ ϮϬϭϮ͖ϱ;ϯͬϰͿ͗ĞϭϳϮͲĞϭϳϯ ĚŽŝ͗ ϭϬ͘ϯϵϬϵͬƌŝŽŐϬϭϵϱď΁

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In the News HERNIA PAIN jcontinued from page 1

compared with heavy mesh, but only in the short term. Longer-term follow-up tends to reveal no difference in pain in these groups (Br J Surgg 2004;91:1372-1376). Such studies, however, focus on average results in the average patient. A subset of individuals can have a severe reaction to these factors. Take mesh, for example. At the World Hernia Conference, Kevin Petersen, MD, a general surgeon practicing in Las Vegas, presented his experiences with mesh and

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / JULY 2015

chronic pain. In the mid-1990s, after surgeons began rapidly transitioning from pure tissue to mesh repairs, Dr. Petersen started to encounter patients with meshrelated pain. In 1995, a patient came to Dr. Petersen, complaining of groin pain so severe that he had to stop working and go on disability. After seeing dozens of surgeons and undergoing a range of pain therapies, the man still had no relief and no answers. After a physical examination, Dr. Petersen saw that the mesh from a previous right inguinal hernia repair was in the exact location of the pain.

“I told the patient that the mesh was likely causing his pain and that, although it had not been done before, he needed his mesh removed,” Dr. Petersen said. The man agreed. Dr. Petersen removed his mesh and the pain disappeared. Soon, Dr. Petersen made a name for himself for removing mesh and started receiving more referrals from other practitioners. “Within the past six years, I’ve seen an explosion in my practice of patients with severe chronic pain,” he said. In Milan, Dr. Petersen presented the results of 114 mesh explants he performed on patients with chronic pain over the past

six years. Of the 88 patients who followed up with Dr. Petersen, 67 were male and 21 were female. The patients had undergone a variety of laparoscopic and open procedures with mesh to repair inguinal hernias (82%) as well as umbilical, incisional, femoral and epigastric repairs. Dr. Petersen performed a formal laparotomy to remove the mesh, and when required, repaired an existing hernia using a modified McVay technique. Complications after mesh explantation were minimal, with two wound infections and eight hernia recurrences. Notably, the average pain score before surgery and in the two years after surgery improved radically. Before surgery, patients reported a pain score of 8.2 on a 10-point visual analog scale, which dropped to 2.7 after surgery (P<0.0001). The majority of patients had significant pain relief: 18% reported being cured of pain and 47% said they felt much better. About one-third of patients did not experience much benefit, with 23% reporting feeling a little better, 8% reporting no change, 3% feeling a little worse and 1% feeling much worse. “Different patients experienced different levels of pain change or relief, but many experienced relief,” Dr. Petersen said. The reason for the pain was not always clear, especially for patients whose pain did not improve after mesh explantation. “Some patients have mesh migrations and meshoma where mesh contracts, but in many cases, I don’t find any technical problems with the mesh implant or the surgical technique. I just see scar tissue that involves the three major nerves in the groin,” Dr. Petersen said. Disturbing or irritating the nerves in the groin, which can occur with mesh as well as with sutures or fixation, can cause pain after inguinal hernia repair. “There’s not a good consensus surrounding chronic pain, but some cases likely have to do with disturbance of the nerves in some fashion,” David Chen, MD, FACS, assistant clinical professor at UCLA Lichtenstein Amid Hernia Clinic, David Geffen School of Medicine at the University of California, Los Angeles, said during a presentation in Milan. In a 2014 study, Dr. Chen and his colleagues detailed the many ways nerves can be damaged after inguinal repair, including surgical manipulation, stretching, crushing, partial or complete transection, or entrapment in a suture or tacks. But the disturbance does not have to be so blatant for a patient to experience pain. Perhaps just the presence of fixation can trigger a pain response. In an expert hot topic debate at the Hernia Congress on mesh fixation in laparoscopic inguinal hernia repair, general surgeon Matthew Goldblatt, MD, highlighted a prospective multicenter study that followed 360

In the News

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patients who had fixation with metal tacks or no fixation during laparoscopic totally extraperitoneal (TEP) hernia repair (Surg Endosc 2008;22:757-762). The researchers found that significantly more patients who had fixation reported pain six to 13 months after surgery (38% vs. 23%), and patients with bilateral repairs were five times more likely to report more discomfort on the fixated side. Still, the data on fixation are not consistent. Dr. Goldblatt also described a study comparing quality of life after TEP, transabdominal preperitoneal (known as TAPP) or modified Lichtenstein repairs, and reported that using more than 10 tacks doubled the incidence of early postsurgical pain but did not affect recurrence rates or chronic postsurgical pain (World J Surgg 2013;37:1249-1257). Postsurgical fibrosis may be another source of chronic pain after inguinal hernia repair (World J Gastroenterol 2011;17:1791-1796). Fibrosis, defined as scarring or the formation of excessive connective tissue in an organ or tissue typically in response to injury, occurs as a normal part of healing, but too much scarring can change the architecture of an organ, inhibit mesh integration and cause pain. A range of mesh properties may influence the degree of fibrosis. During the meeting, Yuri Novitsky, MD, professor of surgery and director of the Case Comprehensive Hernia Center at Case Western Reserve University, in Cleveland, explored the relationship between fibrosis and biocompatibility of mesh. For example, a 2012 study showed that, of synthetic mesh, macroporous polyester mesh implanted in mice resulted in the greatest foreign body reaction and chronic inflammatory response, with expanded polytetrafluoroethylene (ePTFE) also producing a strong fibrosis response, and macroporous, reduced-weight polypropylene mesh exhibiting the best biocompatibility ((J Surg Res 2012;176:423-429). Heavier polypropylene meshes and smaller pores were also associated with more fibrosis. Robert J. Fitzgibbons, MD, Harry E. Stuckenhoff Professor of Surgery at Creighton University School of Medicine, in Omaha, Neb., clarified that “overall, the literature does not support less pain with non-mesh repair.” In fact, Dr. Fitzgibbons noted, the consensus opinion for the European Hernia Guidelines was, “Most studies comparing mesh with nonmesh repair report less chronic pain with mesh repair” (Herniaa 2009;13:385). “The trick is to figure out which patients are going to have an adverse reaction to mesh. This is where research is being focused,” he said. But Dr. Petersen routinely does pure tissue hernia repairs in his practice and he never sees chronic pain. “I continue to perform pure tissue repairs because of my experience taking care of patients who do

have severe debilitating chronic pain from hernia mesh,” he said. Thus, it is important to understand the patient-specific factors that can affect pain outcomes. Some patients are simply more prone to pain. As Henrik Kehlet, MD, a general surgeon from Denmark, noted in his pain presentation, about 3% to 4% of patients have genetic features that may put them at greater risk for persistent pain. Furthermore, as Dr. Petersen noted, patients who have severe pain before surgery are at increased risk for developing severe pain after hernia repair. Surgeon experience may play an

‘I continue to perform pure tissue repairs because of my experience taking care of patients who do have severe debilitating chronic pain from hernia mesh.’ —Kevin Petersen, MD important role in chronic pain after hernia repair as well. Dr. Chen explained that most surgeons don’t do a large enough volume of hernia repairs to become expert at

it, which may cause problems for patients down the line. “Pain is incredibly complex,” Dr. Chen said. “It can result from patient psychological, anatomic and genetic variations, as well as surgical factors.” For reducing pain in the short term, Dr. Champault noted that perioperative cooling of the surgical site can reduce early pain after inguinal hernia repair (Pain Studies and Treatmentt 2014;2:113-120). Options for managing chronic postsurgical pain include spinal cord stimulation, neurostimulation and triple neurectomy, but no technique works in all patients.

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In the News BLACK BOX

jcontinued from page 1 Toronto, Ontario, Canada. Since April 2014, Teodor Grantcharov, MD, a staff surgeon at St. Michael’s, has recorded every step of his laparoscopic operations using a black box of his own design. The box—about the size of a box of tissues—records images from the laparoscopic camera, along with hundreds of data points from around the operating room (OR), such as physiologic details of the patient, conversations between members of a surgical team, temperature and

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / JULY 2015

decibel levels in the room, and a gallery view of the operating theatre. “The concept is very simple,” Dr. Grantcharov explained in a talk at the 2015 annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES). “We need to learn from high-risk, high-performance industries like aviation and adopt the concepts that have been successful for them across so many decades. We need to collect data about our performance and the technology we bring to the operating room.” Dr. Grantcharov’s black box is not

designed for use when a patient has an adverse outcome. Instead, it is used in all cases as a teaching tool so surgeons and trainees can study their surgical technique, much like professional athletes spend hours watching videos of their own performances. In addition to technique, researchers can study other factors—communication, safety processes or room disruptions—that may

Teodor Grantcharov, MD, has recorded every step of his laparoscopic operations using a black box of his own design.

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affect patient outcomes. “We know that as long as there are humans, there will be errors and we cannot change that. These errors lead to chains of events that can lead to adverse outcomes,” Dr. Grantcharov said. “We need to identify and analyze these errors, and we need to do a better job of making ourselves, our colleagues and our trainees aware of these threats to safety.” When the black box was first introduced at St. Michael’s, the system was used in a single OR with a sole surgeon. Now the box is being expanded to more ORs and more surgeons in the hospital, although its utility remains limited to laparoscopic cases. Several beta sites in the United States and Europe will be included in a multicenter trial to test the black box in clinical practice. “We’re moving from being a research initiative to a quality initiative,” said Dr. Grantcharov, adding that his team plans to link their black box data to patient outcomes and cost data. “That will allow us to check, in real time, the impact of this initiative on safety and cost.” To date, no results from the black box study have been published. At SAGES, Dr. Grantcharov reported results from the first 54 surgical cases using the system. In these cases, examiners identified 66 near misses. Dr. Grantcharov said he was surprised by how many near misses were not noticed by the operating team. Three-fourths of the near misses that were identified by reviewers watching the video of the procedures were not noticed by the OR team. “Imagine what a tremendous loss of information there is in knowing that, and a tremendous loss of educational opportunities,” he said. “It makes our M&Ms [morbidity and mortality conferences] a week later seem a bit useless because there is no way that we will remember what happened a week later, when we can’t remember at the end of the procedure.” Many surgeons are wary of surgical

In the News

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black boxes, fearing they could be used against physicians in medical malpractice cases. In 2014, after Dr. Grantcharov’s black box was first reported, a number of law firms blogged about the system with headlines like “Can It End Medical Malpractice?” and “OR Black Box Could Reduce Surgical Negligence.” Again this spring, after Dr. Grantcharov’s talk at SAGES, surgeons expressed concern about how the data would be used. “Who has access to the black box? I can’t look at information from United [Airlines]’s black box. I don’t even get to look at the ones where there is an accident. That’s extremely protected data. … I’m afraid we’re going to let go of that information and that it’s going to be a disaster for our profession,” said a surgeon who spoke at the microphone at the presentation. Despite this, Dr. Grantcharov argues that the black box is an educational tool, not a legal one. In the United States, the Healthcare Quality Improvement Act prevents courts from using data collected for peer review and quality improvement, and therefore any data collected would not be legally actionable. “This is a quality-improvement initiative, and it’s important that this information is protected and used in a confidential, nonpunitive manner,” he said. However, it’s still not known how things would play out if black box data were called for in a potential legal case. At the University of Chicago, Alexander Langerman, MD, assistant professor of surgery and director of the university’s Operative Performance Research Institute, studies the technology and the ethics of surgical black boxes. He said it is understandable that surgeons worry about black box data being used against them, as the issue of black boxes and medicine has never been tested legally. Even in aviation, he pointed out, there are questions in the legal literature about whether black box data could be used in legal action against pilots. “It may be protected from discovery, much like the proceedings of M&M conferences. But the reality is that it has never been tested, so it’s unclear if black boxes would increase the exposure,” Dr. Langerman said. He said surgeons fear that their actions in the OR could be misinterpreted by outside parties called in to evaluate the data. But he felt that as more surgeons collect this type of data derived from cameras and computers, the lower the risk would become that they could be used inappropriately. With more information about surgical procedures, the surgical community would have a baseline standard against which they could compare potentially outlier behavior, Dr. Langerman noted. The main challenge with the current

black box system is that it requires a time commitment from human experts who are willing to review hours of video and data, he said. “That’s not really feasible on a large scale. Instead, we need some kind of automated recognition so that the data that come out have some sort of meaning to it.” Dr. Langerman also said, “A black box like this could help surgeons improve their care, yes. It can help teams learn how to better coordinate their actions and help a hospital figure out where errors are occurring, where their costs are being lost and how they could improve the design or

workflow of an operating room.” Many hospitals in the United States use cameras in the OR, although none has a black box on the scale of the one in Toronto, Dr. Langerman said. Both Drs. Grantcharov and Langerman said they expect that black boxes will make surgery safer for patients. “Patients want a safer and better system,” Dr. Langerman said. “We all get on planes every day, and we know that one of the things that keeps it safe is the systems put in place to help figure out why things go wrong. The people we are charged with protecting have a right to that, too.”

Dr. Grantcharov’s team has done extensive research on surgical error analysis and surgical coaching. In a study published in March in Annals of Surgery (2015 [Epub ahead of print]), he and his colleagues reported results from a trial of 20 surgical trainees who were randomized to either usual training or comprehensive surgical coaching. The coaching included performance analysis, debriefing and feedback based on video analysis. The study showed that trainees who were coached acquired skills significantly faster and reduced their errors by 50% compared with those who underwent usual training.

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Surgeons’ Lounge

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / JULY 2015

Welcome to the July issue of The Surgeons’ Lounge. This issue features David C. Chen, MD, associate professor of clinical surgery, associate director of surgical education and clinical director, Lichtenstein Amid Hernia Clinic at UCLA, Section of Minimally Invasive Surgery, UCLA Division of General Surgery, Los Angeles. Dr. Chen is also a member of the International Hernia Collaboration (IHC), a private Facebook group founded by Brian Jacob, MD, a surgeon from New York City. The group has more than 1,500 international members and serves as a platform for surgeons, health care providers and industry partners interested in hernia repair and optimizing outcomes. In this issue of The Surgeons’ Lounge, Dr. Chen discusses the transversus abdominis release (TAR) procedure. Also in this issue: Take the Surgeon’s Challenge! Stay tuned for the next issue to see how you did. As always, we welcome your questions and comments. Sincerely, Samuel Szomstein, MD, FACS Editor, The Surgeons’ Lounge Szomsts@ccf.org

Question for David Chen, MD Questions and comments are compiled from the International Hernia Collaboration (IHC), a Facebook group. The IHC is a private Facebook group that serves as an international platform for surgeons, health care providers and industry partners interested in the repair of hernia and optimizing outcomes to come together to collaborate, share, discuss, post photos, post videos—simply post anything related to the disease of hernia. With more than 1,500 members, there is a constant exchange of ideas regarding salient topics in hernia repair. It is a dynamic and continuous version of The Surgeons’ Lounge, and all surgeons are invited to join the conversation. (Request addition to this group via Facebook).

Dr. Szomstein n is associate director, Bariatric Institute, Section of Minimally Invasive Surgery, Department of General and Vascular Surgery, Cleveland Clinic Florida, Weston.

Yuri Novitsky, MD, and Michael Rosen, MD. The first publication, in 2012, described this modification of the classic retromuscular Rives-Stoppa technique to facilitate myofascial advancement and mesh placement beyond the lateral border of the linea semilunaris (Am ( J Surgg 2012;204:709-716). TAR is a clever extension of Rives-Stoppa plane that divides the posterior rectus sheath and underlying transversus abdominis (TA) muscle 0.5 to 1 cm medial to the linea semilunaris to access the preperitoneal and retroperitoneal space anterior to the transversalis fascia (Figure 1). Drs. Novitsky and Rosen have subsequently published several studies detailing the efficacy, functional alterations, quality of life and longer-term outcomes, and have popularized this technique through teaching and training, adding a powerful tool to the armamentarium of the surgeon tackling the reconstruction of the complex abdominal wall. Variations including minimally invasive and robotic TAR procedures

Questions 1. What are the advantages of TAR? 2. What are the complications and limitations of TAR? 3. When, if ever, should TAR be used and is it being routinely overused?

Dr. Chen’s

One of the hottest topics in hernia repair has been the popularization of the transversus abdominis release (TAR) in the repair of large and complex ventral hernias. On the IHC Facebook Group, over the past month alone, there have been 38 unique discussion threads related to the topic of TAR and 87 over the past three months. This posterior component separation technique was first developed in 2006 by surgeons

Figure 1. TAR is a clever extension of Rives-Stoppa plane that divides the posterior rectus sheath and underlying transversus abdominis muscle 0.5 to 1 cm medial to the linea semilunaris to access the preperitoneal and retroperitoneal space anterior to the transversalis fascia.

have continued to increase the interest, excitement and adoption of the procedure. What are the advantages of TAR? Abdominal wall reconstruction addresses a complex surgical problem related to the increasing challenge of large, recurrent and/or contaminated hernias in increasingly more complex patients (patients with obesity, loss of domain, ostomies, comorbidities). It requires a combination of techniques including tissue-based repairs, mesh reinforcement, fascial releases, myofascial advancement flaps and minimally invasive approaches. As with the anterior component separation introduced by Oscar Ramirez, MD, in 1990 (external oblique release), division of one of the three lateral abdominal muscles relaxes the abdominal hoop mechanism, allowing for midline advancement to facilitate primary fascial closure. TAR has been shown to provide at leastt equivalent myofascial release to anterior component separation with the added benefits of greater release at the subxiphoid, subcostal and suprapubic locations, which are anatomically fixed and limited for external oblique release. In practice, TAR allows for both greater release and the use of a much larger mesh, facilitating closure of the most challenging cases (Figures 2 and 3). The TA and internal oblique muscles serve as the major contributors to the hoop tension in the lateral abdominal wall, and division of the TA allows for significant advancement of the posterior sheath and midline. Wound morbidity is greatly reduced due to the elimination of subcutaneous flaps, sparing of the periumbilical perforators and preservation of the abdominal wall neurovascular supply. Novitsky and Rosen report that their wound complication rates decreased from 48% to 25% and recurrence rates dropped from 14.3% to 3.6%, comparing TAR with traditional Rives-Stoppa with anterior component separation. With a TAR, much larger pieces of mesh can be placed into the retromuscular position extending bilaterally to the retroperitoneum as needed to allow for the widest overlap possible. Mesh is placed in the well-vascularized retromuscular position, decreasing mesh infections, and

Surgeons’ Lounge

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / JULY 2015

excluded from the viscera, allowing for the use of costeffective uncoated meshes. The goal of the TAR procedure is to medialize the rectus muscles, restore the linea alba, and provide a durable and functional repair. Midline fascial closure provides an additional layer of protection from superficial surgical site infection and mesh exposure. Medialization of rectus muscles in combination with TAR reloads the muscle tension of the anterior abdominal wall and may actually improve oblique function through positive compensatory changes, as evidenced radiographically by hypertrophy of the rectus and external and internal oblique muscles ((J Am Coll Surgg 2014;218:353-357). Functional studies assessing isokinetic and isometric measurements post-TAR demonstrate an improvement in both core physiology and quality of life (Surgery 2014;156:176-182). What are the complications and limitations of TAR? With increasing adoption of this technique, we are starting to see some of the complications of “real-life” practice of TAR, typically related to improper technique and patient selection. Although TAR has been made to look easy by some expert demonstrations, the anatomy must be well understood, and the layers can be both subtle and unforgiving. Accidental compromise of the internal oblique will destabilize the lateral abdominal wall and compromise the neurovascular bundles, leading to both a very challenging lateral hernia and abdominal pain. Lateral component separation procedures are not meant to be combined, and we have seen patients with terrible hernias resulting from a simultaneous anterior and posterior separation. Improper use of this technique has the potential to harm patients because myofascial division involves an anatomic and functional calculated compromise of the structural integrity of the abdominal wall. The posterior plane of a TAR is a very thin layer of transversalis fascia and peritoneum, which must be kept completely intact to separate the mesh from the viscera and can be challenging to preserve with prior lateral incisions and ostomies. A routine intra-abdominal complication such as a small bowel obstruction becomes more complicated after a TAR procedure, as you ideally will never go back into that patient’s abdomen. As with the popularization and subsequent decline in the use of transverse rectus abdominis myocutaneous flaps, there are valid theoretical concerns that TAR may eventually create unrecognized downstream morbidity. “We have evidence that release of the transversus

undergoing compensatory hypertrophy, both anatomically and physiologically.”

Figures 2 and 3. TAR allows for both greater release and the use of a much larger mesh facilitating closure of the most challenging cases. abdominis is detrimental, as it destabilizes the main core strength and can lead to injury. Should we be doing TAR at all?” [Post from Indran Hensman, MD, on IHC group] Exercise physiologists cite that the TA muscle is the muscle group that provides the majority of core strength. It provides stability to the spine, and there may be implications for lower back issues in the future. “Bottom line is we don’t know yet. We get this amazing release … but it comes at some theoretical risk/ cost.” [Post from Mike Rosen, MD, on IHC group] While we do not yet know what the long-term ramifications of TAR will be, Dr. Novitsky posted on the IHC group page that after “hundreds of TARs, I have not seen any proposed disabilities associated with it (ie, back pain). I believe it’s due to the internal oblique

The Surgeon’s Challenge From Joseph Melendez, MD, fellow, Department of Minimally Invasive Surgery, Cleveland Clinic Florida, Weston

n 18-year-old male patient was seen in clinic for a history of intermittent, clear blood-tinged discharge from the umbilicus for the past four months. At times, the discharge is foul-smelling and purulent. The patient was treated with antibiotics by his primary care physician, with no improvement. The patient denies any further symptoms and has no abdominal pain or fever. He is otherwise healthy, with no medical problems and no previous operations. On examination, the abdomen was soft, nontender and nondistended. A small amount of bleeding from the umbilicus was seen when manipulated, but no tract was appreciated. A short course of oral antibiotics was prescribed and a computed tomography scan of the abdomen and pelvis was ordered (Figure). How would you proceed?

When, if ever, should TAR be used and is it being routinely overused? In my own practice, for patients with the largest and most complicated hernias, TAR has facilitated closure of hernias that otherwise would never achieve midline approximation with other methods. As someone who routinely uses the Rives-Stoppa sublay position, I find that TAR is a natural extension and avoids the subcutaneous flaps created with an endoscopic or open anterior component separation. With large transverse separation in the subxiphoid and suprapubic locations, it is an ideal approach. If midline approximation is not possible with a traditional Rives-Stoppa, I have adopted TAR for most open cases that require myofascial advancement. However, most cases should not require component separation and not every patient needs a dynamic abdominal wall. In the obese, smoking, comorbid patient who has not modified risk factors, abdominal wall reconstruction should be avoided and expectant management should be practiced for minimally symptomatic hernias. Symptomatic hernias may be best approached in this group with a laparoscopic ventral hernia repair to minimize complications, if possible. There are many ways to skin a cat and several other techniques, including the Guy Voeller– modified Chevrel onlay, may give the closure needed without entering the abdomen or dividing the TA. With regard to the overuse of TAR and component separation techniques in general, there has definitely been a shift in hernia repair to routine use. “It took four years for Yuri Novitsky and Michael Rosen to publish TAR. One year ago, I would venture to say that there was a minority of the IHC that had heard about TAR, much less employed it in their practice. Now, it is all too common to hear it as a go-to procedure.” [Post from Conrad Ballecer, on IHC group] Every surgery (especially with component separations) burns a bridge, and we need to decide if the benefit is worth the cost and if the individual circumstance has been optimized. “Most hernias don’t need TAR so avoid it. Definitely a good technique but I agree it may be too common a go-to for most hernias.” [Post from Michael Rosen on IHC group] As with most things in surgery, the most important lesson regarding TAR is not technical; it is the clinical judgment to decide which patients will be helped by the procedure.

In the News ROBOT

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Invasive Hernia Repair. The robotic TAR, also known as rTAR, is an exciting, up-and-coming technique that reproduces the open Rives retromuscular incisional hernia repair with the addition of a TAR procedure, which allows for a complete abdominal wall reconstruction. It is also a technically difficult procedure, and concerns have arisen about the likelihood of recurrent hernias after rTAR. General Surgery News spoke with Dr. Carbonell, associate professor of surgery at the University of South Carolina School of Medicine-Greenville and co-director of the Hernia Center at the Greenville Health System, to get his thoughts on the procedure. GSN:: What is a robotic TAR? Take us through the steps. Dr. Carbonell: The procedure entails safe laparoscopic access to the abdominal cavity and placement of three trocars in the lateral abdominal wall along the midaxillary line. The robot is docked and adhesions taken down. The Rives retromuscular repair commences by incising the posterior rectus sheath vertically, close to the edge of the hernia, and above and below it. A retrorectus dissection is made by peeling the posterior rectus sheath away from the posterior aspect of the rectus muscle. Once the lateral edge of the rectus sheath is reached, the TAR is done, dividing the transversus abdominis muscle along its entire length. This allows access to the pre-transversalis fascia or preperitoneal plane. A blunt dissection is made medial to lateral until the peritoneal flap with the attached posterior sheath rests upon the visceral contents below. Then, using a similar configuration to the first side, trocars are placed on the contralateral side. A mesh is cut to the measured size, rolled and introduced into the dissected space; it’s placed, ready to unroll, on the contralateral side, under the newly placed trocars. The robot is undocked from the first side and docked on the contralateral side. We repeat the dissection of the retrorectus space and TAR. Once the dissection is complete, the posterior rectus sheaths are suture-reapproximated in the midline. The mesh is unrolled to occupy the entire retromuscular dissected space. Finally, the anterior rectus sheath and hernia defect are suture-reapproximated, completing the repair. GSN:: How many robotic TARs have you done, and what are the key challenges? Dr. Carbonell: We’ve done 52 robotic Rives repairs, with 60% having undergone

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / JULY 2015

a concomitant TAR. The key challenge to this robotic technique is the learning curve. The surgeon should be adept at the open technique prior to embarking on the even more tedious robotic approach. Suturing with a long suture within the confined retromuscular space can be very frustrating for some surgeons.

It is crucial that surgeons have a clear understanding and experience performing the open Rives retrorectus repair and TAR before they attempt it robotically.

GSN:: Several times during your presentation, you cautioned that surgeons are starting to see complications from robotic TAR. What kinds of complications occurred?

—Alfredo Carbonell, DO

Dr. Carbonell: Two colleagues [of mine] have seen patients referred to them for a recurrent hernia after robotic TAR. From the appearance of the CT [computed tomography] scans and interpretation of the operative reports, it has been surmised that the surgeons divided the abdominal wall at the semilunar line. In essence, the surgeons disconnected the rectus muscles from the oblique muscles. This has been seen multiple times with the open anterior or Ramirez component separation as well. It is simply a matter of surgeons getting lost intraoperatively, incorrectly identifying the abdominal wall anatomy and lacerating the muscles incorrectly. It is crucial that surgeons have a clear understanding and experience performing the open Rives retrorectus repair and TAR before they attempt it robotically. I strongly encourage surgeons who are interested in learning this technique to seek cadaver or animal training courses for robotic Rives repair and TAR. Similarly, the first few attempts at this repair robotically may best be undertaken with another trained surgeon or partner [who is] well versed in the technique. GSN:: How does the robotic approach compare with open? Dr. Carbonell: At the World Hernia Congress in Milan this April, we presented data on a case-control, matched cohort series comparing the robotic approach with the open approach at our institution. We found the benefits of decreased blood loss, equal operative times, lower rate of wound infections, a significantly shorter hospital stay and equal direct hospital cost with the robotic approach. GSN:: How long does it take for you to do a robotic TAR? Dr. Carbonell: The operative time is always predicated on the complexity of the lysis of adhesions. Including cases during our learning curve, our mean operative time is 250 minutes and our median time is 199 minutes. GSN:: Which patients are best suited for this approach?

Dr. Carbonell: The ability to identify the ideal patients comes with experience. For me, I look at wound risk, defect size and location, and abdominal wall compliance. Patients with prohibitive wound risk factors such as smokers, diabetics and obese patients are well suited for this approach since it offers an openstyle repair with laparoscopic morbidity. Although I’ve repaired defects as wide as 13 cm, I generally look for defects smaller than 10 cm on CT scan. Midline defects are best, but lateral defects in the flank and lumbar regions are also amenable and obviate the need for any double-docking. Patients with thin abdominal wall musculature are ideal due to their increased abdominal wall elasticity and compliance. These features help with visualization under pneumoperitoneum and allow for simple defect closure. GSN:: Tell us about the patient you operated on during the meeting. Dr. Carbonell: The patient was a 62-year-old [woman] with hypertension, diabetes and cirrhosis who developed a 9-cm–wide by 23-cm vertical incisional hernia after an ileocecal resection for neuroendocrine tumor.

everything like the instruments not working. They’re totally self-sufficient. I think that’s key. GSN:: How much robotic surgery do you do? Dr. Carbonell: I’ve been on the robot about two years. My impetus to get on the robot was twofold: to do the robotic RivesStoppa and to do reoperative foregut surgery. So far, I’ve done 140 robotic cases total because I really only use it for foregut and robotic incisional hernia repairs. When I first started, like many people, I was doing a standard IPOM [intraperitoneal onlay mesh technique] and docking the robot to close the defect, do lysis of adhesions and hang the mesh. I was trying to get facile with suturing on the abdominal wall in an effort to train myself for that move to do the Rives-Stoppa. GSN:: Do you have any technical pearls for surgeons? Dr. Carbonell: Understand the anatomy open before you attempt it robotically. When performing the TAR, utilize your nondominant hand’s grasper to open up the preperitoneal plane below the transverse abdominis muscle and then cauterize with your scissors over your opened grasper, similar to the open technique. I decrease the pneumoperitoneum pressure down to 8 to 10 mm Hg and use a barbed suture to suture the defect closed. I do not routinely drain the retromuscular space like I would with the open [technique].

Surgeons on rTAR Edward J. Felix, MD

GSN:: You double-dock the robot during this procedure. Is that difficult? Dr. Carbonell: Initially, I was interested in the single-dock technique like Ricardo Abdalla, MD [surgeon at Hospital Sirio-Libanes, Sao Paulo, Brazil] is doing, where he works from inferior to superior in the abdomen. The dual dock approach, however, opens up more opportunity to deal with larger defects that span a great length of the abdomen. We tried initially to leave the robot in place but rotate the patient. I found it cumbersome. Now, we simply drive the robot around to the patient’s other side. This takes a little over four minutes to undock, drive the robot around to the other side, redock and move the scrub tech’s back table.

General Surgeon, Santa Maria, Calif.

I had the privilege of watching Dr. Alfie Carbonell perform a robotic TAR at the meeting in New York City. Before seeing this procedure, I was extremely skeptical of robotic surgery. There has been a lot of false hype about what robotics has to offer. Most procedures done by robotic surgeons can be done faster, cheaper and/ or better with conventional laparoscopic surgical techniques. The TAR, however, is not one of those procedures. There is no question in my mind that the robot has found its place with this procedure. Dr. Carbonell demonstrated that a true TAR can be performed robotically and mimics the open procedure perfectly. So if you believe in the TAR, it may be time to become facile with the robot.

GSN:: Do you have a dedicated robotic team at your hospital?

Guy Voeller, MD

Dr. Carbonell: I do and I think most hospitals do. We certainly have a group of dedicated scrubs. They can troubleshoot

Dr. Carbonell did a masterful job demonstrating the robotic TAR. Should it be

Professor of Surgery, University of Tennessee Health Science Center, Memphis

see ROBOT FOR HERNIA page 16

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In the News ROBOT

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done outside of a controlled study without IRB [institutional review board] approval? I don’t think so. I am concerned about this type of procedure and technology being done on unsuspecting patients by surgeons who are not as expert as Dr. Carbonell in performing the operation. This procedure is in its infancy and should not be done by the novice. There is a huge potential for harm to patients. A huge number of questions remain to be answered about robotic hernia repair

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / JULY 2015

in general, and whether or not it should even be done is the first question. Dissemination of this procedure on a widespread basis is not prudent at this point, to be sure.

Michael Rosen, MD Director, Cleveland Clinic Hernia Center, Ohio

The role of robotics in hernia surgery is an exciting emerging trend. The robot offers several unique opportunities to improve the care of hernia patients. It might allow surgeons to overcome the learning curve associated with laparoscopic inguinal hernia repairs that have

I am concerned about this type of procedure and technology being done on unsuspecting patients by surgeons who are not as expert as Dr. Carbonell. —Guy Voeller, MD plagued that procedure and prevented many patients from experiencing benefits from a minimally invasive repair. It could

offer a minimally invasive approach to some of the more advanced reconstructive procedures such as a posterior component separation with TAR, as recently shown by Dr. Alfie Carbonell. Finally, it might replace many mesh fixation devices that are currently used in laparoscopic repairs and are quite expensive. All of these opportunities for the robot to improve the care of our patients are real, but it is of paramount importance that we, as surgeons, evaluate these outcomes in carefully designed studies or leveraging ongoing registry data, such as the Americas Hernia Society Quality Collaborative.

Eric M. Pauli, MD

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See the evidence and full product information at www.Ethicon.com Color sticky notes represent customer insights. *In animal studies. 2 References: 1. Data on file. Ethicon, Inc. A. Holste J-L, Muench T, Shnoda P, Wohlert S, McRoy L. A preclinical evaluation of the tissue separation and abdominal wall integration properties of ETHICON PHYSIOMESH™ Flexible Composite Mesh. PHYSM 336-10-8/12. Ethicon, Inc. B. Holste J-L, Muench T, Shnoda P, Wohlert S, McRoy L. An evaluation of ETHICON PHYSIOMESH™ Flexible Composite Mesh in the prevention of adhesions in a rabbit model of abdominal hernia repair: a comparative study. PHYSM 335-10-8/12. Ethicon, Inc. C. Ethicon Hernia Dashboard 2014. D. Final Report, PSE Accession No. 13-0058, Project No. 12736. May 19, 2014. E. Final Report, PSE Accession No. 14-0099, Project No. 12736. November 14, 2014. F. Final Report, PSE Accession No. 13-0041, Project No. 12736. July 29, 2013. G. Report for 510k Testing for ETHICON PHYSIOMESH™ Open Flexible Composite Mesh Device, Version 2. May 14, 2014. 2. ETHICON PHYSIOMESH Open Flexible Composite Mesh Device. Instructions for Use. Ethicon, Inc. 3. Klosterhalfen B, Junge K, Klinge U. The lightweight and large porous mesh concept for hernia repair. Expert Rev Med Devices. 2005;2(1):103-107. 4. Cobb WS, Kercher KW, Heniford BT. The argument for lightweight polypropylene mesh in hernia repair. Surg Innov. 2005;12(1):63-69. 5. Junge K, Klinge U, Prescher A, Giboni P, Niewiera M, Schumpelick V. Elasticity of the anterior abdominal wall and impact for reparation of incisional hernias using mesh implants. Hernia. 2001;5:113-118.

Assistant Professor of Surgery, Director of Endoscopic Surgery, Penn State Milton S. Hershey Medical Center, Hershey, Pa.

Robotic TAR represents a step forward in several ways: It’s unique to the robotic platform. There is no laparoscopic TAR equivalent. By avoiding the midline laparotomy incision, surgical site occurrence rate, pain and volume shifts are minimized. Dr Carbonell’s early experience suggests a dramatically shorter hospital stay after rTAR, which will likely offset the cost of using the robotic platform. Caution should be emphasized, however, to those interested in learning this exciting new operation. It requires a firm grasp of abdominal wall anatomy. There are presently many more surgeons using the robot than there are surgeons performing TAR. As robotic-capable surgeons have started to make the leap into hernia repair, we have already begun to see rTAR-specific complications (such as full-thickness division of the linea semilunaris) that are the direct result of inexperience with performing open TAR and with unfamiliarity with the specific abdominal wall anatomy. Furthermore, rTAR has been utilized almost exclusively for midline incisional hernias. It remains to be seen whether the technique will be as versatile as its open counterpart in addressing more complex defects (parastomal, paramedian, subcostal, flank, those with loss of domain). Dr. Carbonell reported that he is a speaker and instructor for Intuitive Surgical. Dr. Rosen is a speaker for Bard and has received research grants from W.L. Gore.

In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / JULY 2015

The Apple Watch and Surgery: The Best Thing Since the Autoclave B Y P AUL W ETTER , MD

f only you could sterilize the watch, life would be great! Get ready because smapps (science and medical apps) are about to change health care for all specialties in a big way. I have tracked this revolution very closely for the past few years and can say with certainty that the next several years will bring a plethora of game changers for health care, including the surgical field. We are on the cusp of an avalanche of smapps, supercomputers in our cell phones and servers that can crunch big data—all of which are going to be disruptive in both good and bad ways. The advent of the Apple Watch and wearable technology will usher in a futuristic age, one that is only a few short years away. Sometime in the next year or two, you will see a message on your wrist that your patient may have an infection, beforee the patient feels sick. This text won’t come from a human. You will get another text that a patient may be anemic because the sensors in her watch show persistent tachycardia. The permutations are limitless and involve the technology that has become so commonplace in other aspects of our lives. After all, we only check our patient’s pulse and temperature every four to six hours, or if he or she complains

of symptoms. Imagine when these metrics are being checkeed on millions of people every second by their supercomputer watches. Ubiquitous servers then analyze all these data, sending acccurate predictive results bacck to your watch instantly. Since Apple announced d its new watch, theree has been much speculation about its capabilities. We now know that the first model can check a person’s pulse, and that newer models will have a powerful processor to keep track of health data. We alsoo know there are alreadyy apps available for it likke Epocrates or Microm medex, but also HIPAA-ccompliant messaging from veendors including Doximity and d TigerText. But what aboutt Android technology? It seems th hat 85% of the mobile traffic for soome health companies comes from iPh iPhones

and iPads. Phyysicians have for the most part embraced App ple, so app developers are working on those d devices first. When I atttended the Apple Worldwide Developers Conference last summer, it was alreeady evident that more people were working on smapps than had workked on every medical breakthroough since the dawn of twigs foor splints—9 million app develop pers and doubling every year! Aside from the smapps, the Ap pple Watch is truly a smart piecee of technology, perfect for the praccticing physician. It needs an iPh hone 5 or greater as its main braiin and communication hub, but you u won’t notice the phone in your poccket. It will display your schedule, tap you on the arm when the operrating room is ready and tap you aagain when you have a message from yyour office or your patient. “Watch h,” this is going to be big.

— —Dr. Wetterr iis the chairman of SLS, a minimally invasive surgery society. He can be reached at P Paul@SLS.org. l@SLS

Opinion

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / JULY 2015

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and public health world by storm. The report underscores some of the stark facts of the human consequences of lack of access to the most basic surgical services: Up to 7% of deaths in the world’s poorer countries could be averted by the provision of essential surgical services. That translates to 1.5 million lives saved annually, which includes those lost to obstructed labor, road traffic crash injuries, untreated intestinal perforations and other conditions.

But this springtime of global surgery has more subtle and important contextual messages. We know that surgery saves lives. What we are only beginning to prove is that even in contexts where life is cheap, surgery can save lives cheaply. As health care economists, both at home and abroad, turn their attention to the cost-effectiveness of interventions, we now have models that convincingly demonstrate that emergency low-level (and even some more advanced) surgical interventions can save lives and prevent disabilities just as cheaply as vaccination campaigns and the fight against

Nowhere is it harder to reconcile the sight of overcrowded hospital wards that have run out of the most basic supplies with that of shiny new tanks on the streets and hand grenades for sale in the town market for 50 cents.

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There arre inherent risks in all medical devices. Please refer to the product labeling for Indications, Cautions, Warnings, and Contraindiccations. Failure to follow the product labeling could directly impact patient safety. Physician is responsible for prescribing and administering medications per instrructions provided by the drug manufacturer. Refer to www.halyardhealth.com for product safety Technical Bulletins. 1. Sherw winter DA, et al. Continuous infusion of interperitoneal bupivacaine after laparoscopic Surgery: A randomized controlled trial. Obes Surg. 2008: 188 (12): 1581-6. 2. Klein et al. Interscalene brachial plexus block with continuous catheter insertion system and a disposable infusion pump. Anesth AAnalg. 2000; 91:1473-8. 3. Data on File. ON-Q* Pain Relief System. *Registered Trademark or Trademark of Halyard Health, Inc. or its affiliates. © 2015 HYH. All rights reserved.. RX Only.

malnutrition. Hernia surgery, emergency cesarean delivery, open fracture treatment—all these interventions that have been thought of as pricey or “fancy” interventions are no more costly than providing rehydration solutions for cholera, vaccination campaigns for measles outbreaks or antiretroviral medications for HIV/AIDS. The demographics of surgically treated disease are slowly changing across the world. Although cardiovascular disease and cancer will claim more and more lives as poor countries industrialize and life expectancies increase, people dying from lack of surgical care in the world’s poorer regions are still overwhelmingly young. Motor vehicle crashes, postpartum hemorrhage, injuries from violence, birth asphyxia and trauma all disproportionately affect the young. Additionally, up to one-third of childhood cancers may be curable by surgery alone. Saving these lives can have a profound effect on the economic health of a country, as well. Another important message of the “Disease Control Priorities” project was that safe surgery not only saves lives, but also leads to a substantial reduction in the long-term financial toll of injuries and disease. Surgical services may reduce by 10% the total impact on disability caused by disease and injury worldwide—no small consideration in countries with scant resources to provide financial assistance to families whose main breadwinner is sidelined. Our work has taken us to the Bolivian “altiplano,” the war-torn eastern Democratic Republic of the Congo, rural India and the civil strife of the Central African Republic’s capital, Bangui. Nowhere have we seen more clearly the stark contrasts between the inaccessibility of usual and essential health care services and the widespread access to arms. Nowhere is it harder to reconcile the sight of overcrowded hospital wards that have run out of the most basic supplies with that of shiny new tanks on the streets and hand grenades for sale in the town market for 50 cents (U.S.). World Bank data reveal that lowincome countries spend more than high-income countries on military

Opinion

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / JULY 2015

after the fall and treated appropriately? Surgery need no longer be seen as an expensive, specialized intervention reserved only for countries with resources. It has a role in virtually every part of public health care, from trauma prevention to the treatment of communicable diseases (tuberculosis, complications of HIV/AIDS, abscesses and so on). Its role extends from mitigating the consequences of obstructed labor to treating noncommunicable diseases, such as cancers and cardiovascular disease. Surgery is safe, effective and cost-efficient. It is our task, duty and privilege as expenditures when measured as a percentage of central government spending, and less than half that of high-income countries on health care when measured as a percentage of gross domestic product. Western European countries and the United States spend perhaps 60% of their total health care budgets on public health sector financing, while the world’s poorest countries spend less than 40%. Why is it so hard to stand up against disproportionate fiscal priorities? On May 22, the World Health Organization’s World Health Assembly passed a seminal resolution: to strengthen emergency and essential surgical care and anesthesia as a component of universal health coverage. It is an important step in the politics of global health that acknowledges the primacy of safe and accessible basic and emergency surgical services across the world. Furthermore, the motion makes the argument that surgical services must be tied to health care access, and places the responsibility of health care provision firmly in the lap of member nation states. Solutions to the problems of poor access to surgical services in resource-poor regions of the world cannot rely on external agencies and humanitarian support alone. Without sustained advocacy at the international level, the world’s most vulnerable populations will see little improvement in health care. But we need to do more. Surgical care does not happen on paper or in meetings, and it will not happen equitably, safely and quickly unless we demand more from governments across the world. We need action and accountability to follow advocacy and policy for the neglected surgical patient. We can remove a ruptured uterus, but why should we when a safe cesarean delivery can avoid that situation? We can amputate a limb infected from a neglected open fracture, but why should we when timely treatment can let the patient walk out of the hospital on crutches on the way to full recovery? We can perform an emergency exploratory operation too late on a child five days after a fall from a tree, but why should we when we can strengthen trauma systems to the point where that child is seen immediately

health care economists, surgeons, anesthetists and advocates to make that message clear not only to worldwide humanitarian and transnational governing organizations, but to all governments and patients.

Surgical Initiative. She is also the membership committee chair for the Global Alliance for Surgical, Obstetrics, Trauma and Anaesthesia (G4).

—David H. Rothstein, MD, MS, — is a pediatric surgeon at the Women and Children’s Hospital of Buffalo, N.Y., and works regularly with Doctors without Borders. Mamta Swaroop, MD, is a trauma and critical care surgeon at Northwestern Memorial Hospital, Chicago, where she founded the Northwestern Trauma and

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

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GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / JULY 2015

Robot Fares Well Against Laparoscopy for Colorectal Outcomes, Costs B Y P AUL B UFANO NASHVILLE, TENN.â&#x20AC;&#x201D;Robotic colectomies are comparable to laparoscopic colectomies in terms of overall hospital costs and short-term clinical outcomes, including hospital length of stay and conversion rates, according to a study presented at the 2015 annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons.

â&#x20AC;&#x153;Robotic surgery has definite technical advantages for surgeons over laparoscopy, with better ergonomics, ability to use EndoWrist [Intuitive Surgical] movements in a tight space, improved precision and maneuverability, and superior [three-dimensional] visualization of tissues,â&#x20AC;? said lead investigator Vanitha Vasudevan, MD, a general surgeon in surgical oncology, in Miami, who presented the results at the meeting (abstract P501).

â&#x20AC;&#x2DC;The study will definitely have clinical implications because if the costs between laparoscopy and robotic colorectal surgery are comparable, it will be more widely accepted by surgeons.â&#x20AC;&#x2122; â&#x20AC;&#x201D;Vanitha Vasudevan, MD

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â&#x20AC;&#x153;There is also a shorter learning curve to transition from open surgery to a robotic platform, something that could bolster widespread acceptance among surgeons in the community,â&#x20AC;? added Dr. Vasudevan, who was the chief resident at University of Miami/Palm Beach Regional Campus/JFK Medical Center, in Atlantis, Fla., at the time of the study. Dr. Vasudevan and her team conducted a retrospective chart review of laparoscopic and robotic surgeries performed for benign and malignant colorectal diseases at a high-volume community hospital between January 2011 and July 2013. There were 131 patients in the laparoscopic arm and 96 patients in the robotic arm. Measured outcomes included operating time, hospital length of stay (LOS), conversion rate, complications, 90-day readmission rate and mortality. The average operating time was similar in the laparoscopic and robotic groups (113 and 109 minutes, respectively). Similarities were also seen in the mean hospital LOS (6.6 and 5.7 days, respectively) and major postoperative complications (3.1% and 7.3%). The mean overall hospital cost was $114,853 for laparoscopy and $107,220 for robotic surgery, respectively, which did not differ significantly. Finally, no deaths occurred in either group. The researchers also found that the robotic group had a lower mean age (63.6 vs. 70 years), but was comparable to the laparoscopic arm in terms of sex, body mass index, type of pathology and American Society of Anesthesiologists classification. Although not directly observable in this studyâ&#x20AC;&#x2122;s analysis, reducing the hospital LOS, complications and readmissions are also likely to indirectly bring down the overall hospital cost, Dr. Vasudevan said. â&#x20AC;&#x153;The study will definitely have clinical implications because if the costs between laparoscopy and robotic colorectal surgery are comparable, it will be more widely accepted by surgeons,â&#x20AC;? Dr. Vasudevan said. â&#x20AC;&#x153;While there is a high initial cost for robotic setup in a hospital, increasing the number of cases done using the robot and increasing experience for both the surgeon and operating room staff will contribute to reducing the costs per case.â&#x20AC;?

khorty@mcmahonmed.com.

In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / JULY 2015

Administering Death, Terminating Suffering (Part 2) B Y C HRISTIANNA M C C AUSLAND

regon passed its Death with Dignity Act (DWDA) in 1997, allowing doctors to write a lethal prescription for terminally ill patients. The state tracks DWDA’s use in an annual report. While the reporting isn’t flawless, it’s clear that year after year more people obtain a DWDA prescription than use it. In 2014, 155 patients obtained a DWDA prescription and 105 people died by using it. Since the law passed, 1,327 people have had DWDA prescriptions written and 859 patients have died from the medication. The same is true in Washington, whose law became active in 2008. In 2013, 173 prescriptions were written and 119 individuals were confirmed to have died by taking the medication. Some patients die from their illness before taking the medication. But for others, like Dr. Egbert’s patient in New Jersey, knowing there is an alternative to a painful end or a messy, possibly botched suicide attempt may be enough. Ms. Maynard ultimately used her DWDA prescription, but in the short video she recorded for Compassion & Choices that propelled her into the national limelight, she explained that it was “a relief ” to know that she was in possession of an alternative to the death she was told to expect if she chose to let her brain cancer take its course. “You get some peace of mind knowing that the end of your life is within your control and not dependent on someone else,” Dr. Kavanaugh said, “or that you won’t end up in a critical care unit with things plugged into every orifice.” Mildred Z. Solomon, EdD, president and CEO of The Hastings Center, a nonprofit bioethics research institute in New York, said the physician aid-indying movement touches the fundamental cultural fabric of our nation. “Support for physician aid-in-dying, or what opponents call assisted suicide, aligns with the American emphasis on choice and autonomy and our desire to enable self-determination,” she said. Critics of physician-assisted suicide fear that the practice will become widespread and disproportionately affect the poor and the disabled. Dr. Solomon had similar concerns, but now says the data show otherwise. In Oregon and Washington, the number of people using DWDA has risen over time (in 1998, only 24 people got a DWDA prescription and 16 died), but the overall number of people who use the act is relatively small. The vast majority are white, well educated and suffering from

cancer (although 2014 did show an uptick in those with amyotrophic lateral sclerosis). The median age in Oregon was 72 years, and 93% of those who sought a DWDA prescription were enrolled in hospice care. Dr. Solomon said many of the potential abuses that people originally worried about have

not come to pass, and she wouldn’t be surprised if twice as many states have laws on the books in the next 18 months. However, she worries that over the long term, as health care costs rise and more financial burdens are placed on families, people may seek to use legalized death with dignity

laws to save their families from the cost of a prolonged illness. “That’s not a reason not to legalize it, but there should be vigilant monitoring to make sure states with legal assisted death adhere to protocols.” She noted that the conversation will become more complex as the number of people living longer with Alzheimer’s and other dementias increases. Current see SUFFERING page 22

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SUFFERING

jcontinued from page 21 death with dignity laws do not apply to people with dementia because they lack the mental capacity to make such decisions. But people in the early stages of Alzheimer’s, or who are worried that they will develop the disease, may want to assert a right to choose assistance with death.

A Global Movement Outside the United States, both assisted suicide and euthanasia appear to be gaining some ground. The practices are legal in Switzerland, Germany, Albania, Colombia and Japan. There are more than 50 right-to-die societies in approximately 23 countries. A Swiss organization, Exit, announced in mid-March that its membership has been surging in recent years. In the German- and Italian-speaking parts of Switzerland, the group’s membership rose to 81,015 people, up from 67,602 in 2013. In 2014, Exit helped 583 people to die. Belgium and the Netherlands have some of the most liberal policies, including ones allowing euthanasia. The Dutch, who decriminalized both euthanasia and physician-assisted suicide in 2001, had over 4,000 people die by choice in 2013. Most were older people and about 80% to 90% had cancer, but the Dutch law allows anyone in “hopeless and unbearable suffering” to seek euthanasia, without the requirement of a terminal diagnosis. While the number of people opting for euthanasia is growing, Rob Jonquiere, MD, a retired physician and now communications director of the World Federation of Right to Die Societies, attributed this to greater awareness of the law and more open conversation in Dutch society about death than to the proverbial slippery slope. “If it was a slippery slope, you would see maybe only 60 percent of cases were terminal cancer, for example,” he said. “We can only explain the growth by saying the medical society and the patients are more or less used to the fact that euthanasia is a possibility and it’s now integrated with palliative care.” Dr. Jonquiere, a general practice doctor who has performed euthanasia, was the CEO of the Dutch Right to Die Society until 2008, and has been extensively involved in the development and implementation of the Dutch euthanasia law. He sees the global tide swaying in favor of the right to die movement, something he attributes to the baby boomer generation. “The people who grew up after World War II is the group who has formed their own lives and made choices all their lives for contraception and marriage—that

‘Our whole system [was] designed for an era when we died of acute illness or died of infection, not for the baby boomers who will have long-term chronic illnesses. —Mildred Z. Solomon, EdD, president and CEO of The Hastings Center group is now getting to the age when they’re going to die and they want to make the choice there as well,” he said. “By legalizing and protocolizing an act that’s being practiced by doctors, you make it possible to not do things in secret where it can be abused.”

‘Do No Harm’ It is an argument used by advocates for everything from the legalization of abortion to marijuana—that it’s better to put controversial practices into the mainstream where they can be regulated. Some believe that doctors in the United States are already offering physician-assisted suicide, writing out prescriptions for sleeping pills with a wink and a nod. As is often the case with certain hotbutton social issues, religious groups object on moral grounds. But what of the ethics issues for doctors? The American Medical Association stated in its opinion 2.211, “Physician-assisted suicide is fundamentally incompatible with the physician’s role as healer, would be difficult or impossible to control, and would pose serious societal risks.” Dr. Egbert stated he doesn’t like what he did as an exit guide, but that he is very proud that he had the courage to step out of the mainstream and help those in need. Dr. Jonquiere, who was practicing euthanasia in the Netherlands before it was legal, said, “No doctor in the Netherlands kills his or her patient—the law is about terminating sufferingg not terminating life. This is not wordplay, but the basis of our law. In the Hippocratic Oath, you have the obligation to take away suffering and sometimes that can only be done by taking away life.” Dr. Solomon agreed with this point. “Ending suffering is part of the physician’s role and relief of suffering is just

as important, if not more, than cure,” she stated. “But, physician aid-in-dying isn’t the only way to alleviate suffering.” She noted that when the issue is looked at on a case-by-case basis, it’s easy to be swayed by compassion. Ms. Maynard used her video to describe the death she planned: “I will die upstairs in my bedroom that I share with my husband, with my mother and my husband by my side, and pass peacefully with some music that I like in the background.” Dr. Solomon pointed out that individual stories are very moving, but focusing on one person’s tragic circumstances gives physician aidin-dying more prominence in the media than it warrants. When she looks at the data coming out of Washington and Oregon, she sees a practice that is very important to a small number of people. “Unfortunately, though, there is far less attention paid to the larger, systemic need to reform and improve palliative care that could benefit so many more people.” “Our whole system is designed for an era when we died of acute illness or died of infection, not for the baby boomers who will have long-term chronic illnesses,” she said. “There’s so much we need to do for the vast majority of people, why not get just as passionate about redesigning a system that will help everyone?” The AMA opinion continued: “Instead of participating in assisted suicide, physicians must aggressively respond to the needs of patients at the end of life. Patients should not be abandoned once it is determined that cure is impossible. Multidisciplinary interventions should be sought, including specialty consultation, hospice care, pastoral support, family counseling, and other modalities.” Yet it is just this, the feeling of abandonment, that assisted suicide advocates say is often the problem. Dr. Kavanaugh

said his years as a professor of medical and public affairs at George Washington University Health Center, in Washington, D.C., were eye-opening. “I came away with the feeling that we did a really great job of intervening in people’s lives and making them better, but when we couldn’t do that, too often we walked away from them at the most critical point in their life.” Dr. Egbert believes that many patients in need of palliative resources get lost in a quagmire of specialists and consults. “[Guides] are there to educate a person about how to do this themselves, but the other key word would be ‘comfort,’” he said. “A lot of people who are suffering and getting ready to die are very lonely and find out that a lot of physicians abandon them.” According to Dr. Egbert, most patients and families thank him for his help in guiding a loved one to a peaceful, dignified death. But what about the woman with terminal cancer in Texas who started him on this path? “Her daughter talked her out of it,” he said. “According to the minister, she lived two months in horrible pain. But she died with the respect of her daughter. So which one is better or worse? I don’t know the answer to that, but I know that she chose.”

The Aging Physician A Mini-Symposium The Department of Surgery Cedars-Sinai Medical Center Los Angeles, California April 2015 Speakers A Surgeon David Cossman, MD A surgeon faces PGY-XLII A Neurologist Hart Cohen, MD Should physicians undergo cognitive and motor testing on a regular basis? A Surgeon-Pilot Randy Sherman, MD With ongoing cognitive/motor testing is mandatory retirement for pilots appropriate? A Medical Staff Lawyer Lauren Polak What are the medical staff implications of an aging staff?

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REPORT Preventing Retained Surgical Sponges: Clinical and Economic Considerations

Faculty

Overview of Retained Surgical Objects

Carl Boyd, MD

Inadvertently leaving behind a sponge or instrument at the end of an operation is an uncommon but serious medical error (Figure 1).1 The incidence of RSIs, sometimes referred to in the medical literature as gossypiboma, varies markedly among different reports, possibly due, in part, to the reluctance of hospitals and clinicians to disclose these errors for privacy, adverse publicity, or liability reasons, or because some patients may remain asymptomatic for long periods of time and therefore go undetected.1,2,5,6 Regardless, a representative national sample of inpatient administrative claims suggests that the RSI rate may actually be as high as 1 per 7,000 surgical admissions.7 Wan and colleagues reviewed 254 cases of RSIs published between 1963 and 2008, and found the abdominal/pelvic cavity/vaginal vault (74%) was the most common site for RSIs, followed by the thoracic cavity (11%).8 Furthermore, in a study of nearly 300 surgical patients, surgical sponges comprised 69% of all cases of RSIs, which is consistent with results from other studies.1,9 The bodyâ&#x20AC;&#x2122;s pathophysiologic response to RSSs can consist of an exudative or an aseptic fibrous tissue

Professor of Surgery Mercer University School of Medicine Memorial Health Medical Center Savannah, Georgia

Lawrence Lottenberg, MD Former Associate Professor of Surgery and Anesthesiology University of Florida College of Medicine Gainesville, Florida

etained surgical instruments (RSIs), which primarily consist of retained surgical sponges (RSSs), can have a profound effect on patient outcomes, health care costs, and provider and institutional reputation.1-3 Traditional methods of accounting for sponges, such as manual sponge counting and intraoperative radiography before surgical site closure, are unreliable and prone to error.2-4 This monograph provides an overview of the epidemiology and consequences of RSSs, discusses adjunct detection technologies for the prevention of RSSs, and reviews clinical data regarding the efficacy and costeffectiveness of these prevention strategies.

Supported by

REPORT reaction.10 The exudative reaction occurs earlier in the postoperative period and may manifest as infection secondary to bacterial contamination.6,11 The aseptic fibrous type of reaction occurs later and involves fibroblasts, leading to formation of adhesions, granulomas, or pseudotumors, with patients potentially remaining asymptomatic for many years.6,11 The clinical presentation of RSIs such as sponges, varies and depends on the site and type of tissue reaction elicited. Early reactions can consist of unexplained pain or signs and symptoms of abscess formation or sepsis.2 More delayed clinical presentations include wounds that do not heal, or signs and symptoms of intestinal obstruction or fistulization.2 Sponges can migrate transmurally and enter nonsterile compartments (eg, intestine, bladder, airway/lung, stomach), further increasing the risk for RSS-related infection, sepsis, or death.6 In a study of medical records associated with all claims or incident reports of an RSI filed between 1985 and 2001 with a large malpractice insurer representing one-third of the physicians in Massachusetts, Gawande and colleagues reported that RSIs resulted in serious sequelae, including reoperation for removal (69%), readmission to the hospital or prolonged hospital stay (59%), sepsis or infection (43%), fistula or small bowel obstruction (15%), visceral perforation (7%), and even death (2%).1 Among other studies, the mortality rate associated with RSSs was much higher and ranged from 10% to 35%.12

Economic Effects of Retained Surgical Objects Complications of RSIs result in a marked increase in health care costs. The average per-incident costs for an RSI is approximately $63,631 for unreimbursed procedural costs and an additional $25,000 for associated secondary infections

A. Postoperative Day 1

that are not otherwise reimbursed by the Centers for Medicare & Medicaid Services (CMS).13,14 Legal costs, including legal defense fees and malpractice settlements, are estimated to be on average $370,000 per incident.15,16 There are also time consideration costs to searching for missing sponges as well as administering X-rays.17 The indirect costs of an RSI (eg, related to absence from employment or school, the need for caregiver support) have not been quantified. Although liability and litigation are often described as adverse consequences of RSIs, perhaps less recognized is the profound effect of RSI-related complications on the patientâ&#x20AC;&#x2122;s emotional health and trust in the health care system, as well as the negative publicity and distress for the providers and institutions involved.18,19

Risk Factors Several groups of investigators have attempted to characterize risk factors related to the occurrence of RSIs, particularly sponges (Table).1,20 For example, in a multivariate analysis of patients with RSIs by Gawande and colleagues, factors that significantly increased the risk for retention of a foreign body were emergency surgery (risk ratio [RR], 8.8; 95% confidence interval [CI], 2.4-31.9), unplanned change in the operation (RR, 4.1; 95% CI, 1.4-12.4), and body mass index (RR for each 1-unit increment, 1.1; 95% CI, 1.0-1.2).1 In a similar multivariate analysis by Lincourt and colleagues, factors associated with a significantly higher risk for RSIs were the total number of major procedures performed (odds ratio [OR] 1.6; 95% CI, 1.1-2.3), as well as an incorrect count (OR, 16.2; 95% CI, 1.3-197.8).20 In a root-cause analysis, Steelman and Cullen reported that distraction, time pressures, multitasking, and not following standardized procedures were the most frequent factors related to the risk for RSSs.21

B. Postoperative Day 12

Figure 1. An unintentional retained surgical sponge on postoperative day 1 and postoperative day 12.

REPORT Based on these and other data, the Joint Commission classifies the unintended retention of a foreign object in a patient after surgery or other invasive procedure as a reviewable sentinel event.22 Furthermore, an RSS is included in the list of 29 adverse events issued by the National Quality Forum.23 In 2007, the CMS announced its decision to deny reimbursement to hospitals for the costs associated with objects left in patients during surgery.24

Strategies To Prevent Retained Surgical Sponges To prevent RSSs, surgeons and operating room (OR) staff have relied on manual counting protocols and “cavity sweeps”; however, each method is prone to human error.22 Current practices for counting sponges have a 10% to 15% error rate.25,26 Additionally, nearly 88% of all RSSs occur when sponge counts are thought to be correct.1 According to the sentinel event data, an incorrect or “discrepant” count in 52 of the 772 SSI sentinel events was reported to the Joint Commission. 22 The Pennsylvania Patient Safety Authority’s Reporting System database shows that 22.3% of RSIs were associated with a discrepant count.27 Furthermore, Egorova and colleagues retrospectively analyzed count discrepancy data stored in a webbased “near-miss” and patient-harm reporting system over a 4-year period (2000-2004), and reported that the sensitivity and specificity of surgical counting as a screening method were 77.27% and 99.32%, respectively.7

The Association of periOperative Registered Nurses (AORN) recommends a multidisciplinary approach to the prevention of RSIs that includes a standardized approach and global accountability for all team members.28 Although the AORN stresses that minimization of distractions is key to reducing error in manual counting protocols, this goal is not always achievable in the operating suite, especially with the increasing complexity of surgical procedures or in the setting of urgent or emergent procedures or unstable patients.28 Therefore, the AORN recommends that perioperative staff supplement manual count procedures with adjunct technologies.28 Similarly, the Joint Commission recommends using a standardized counting system to account for all surgical items,22 whereas the American College of Surgeons (ACS) recommends the use of x-rays, barcoding, or radiofrequency to prevent the retention of surgical instruments.29 The ideal system should be highly accurate and reliable, simple to use, rapid, and cost-effective.

Intraoperative Radiography Radiography has been the primary method of screening for RSIs, and best practices include the use of radiopaque (x-ray– detectable) surgical items to facilitate visualization.2,9 Although some facilities obtain radiographs on all patients undergoing an open-cavity operation, most use radiography only when the count is incorrect.1,5,11 Radiographs can be expensive and time-consuming. They expose the patient to ionizing radiation, and they are not always reliable, especially when looking for needles and sponges.4,9,30

Table. Risk Factors for Retained Surgical Instruments Identified in 2 Retrospective Case–Control Studies

Study

Risk Factors for Retained Surgical Instruments

P Value

Risk Ratio (95% Confidence Interval)

Gawande 2003

Emergency procedures

<0.001

8.8 (2.4–31.9)

Unexpected change in operation

0.01

4.1 (1.4–12.4)

BMI (per 1-unit increment)

0.01

1.1 (1.0–1.2)

Multiple surgical teams

0.1

3.4 (0.8–14.1)

Estimated blood loss (per 100-mL increment)

0.19

1.0 (1.0–1.0)

Change in nursing staff during procedure

0.24

1.9 (0.7–5.4)

Counts of sponges and instruments

0.76

0.6 (0.0–13.9)

Number of major procedures performed

0.008

1.6 (1.1–2.3)

Incorrect counts recorded

0.02

16.2 (1.3–197.8)

Multiple surgical teams

>0.05

5.4 (0.9–33.1)

Lincourt 2007

BMI, body mass index Based on references 1 and 20.

REPORT Indeed, the sensitivity of intraoperative radiographs for detecting a retained item has been found to be 67% effective, while another 10% of radiographs have been found to be falsely negative for radiopaque sponges.9,19 Steelman and colleagues used radiography on morbidly obese patients to assess the presence of a retained sponge in the abdomen, and found that it often required 2 overlapping radiographs, an estimated 30-minute extension to the OR time, and also an increased risk for contamination of the surgical drapes.31 Furthermore, a key clinical study showed the probability of detecting an RSI as being 3.9 per 100,000 operations, the cost of performing routine intraoperative radiography to prevent RSIs, including sponges is estimated at $11.5 million for every clinically harmful object detected (based on a cost of $450 screening x-ray, which includes technician time and radiology fees).30,32

Barcoded Sponges Some hospitals also use barcoded sponges, which consist of a scanning device, and 2-dimensional, matrix-labeled sponges that are individually identified. Before the surgical procedure, the sponge packs are scanned in with the sponges then individually scanned off the sterile field.17 Because this is essentially a computer-assisted physical counting system, it is a time-consuming activity and also can be just as vulnerable to some of the same types of human errors otherwise associated with current manual counting approaches.17,18 For example, failure to manually scan a sponge or sponge pack before placing it within the operative field can result in a false-negative count when removing sponges from the field. Furthermore, the sponges must be found and removed from the patient in order to count them because the scanner cannot read through or detect the presence of a sponge inside the body.18 Although this system can account for sponges placed in or removed from the operative field, it cannot localize the missing sponge within the patient or elsewhere in the operating suite. As a result, when the manual and barcode counts do not match, intraoperative x-rays are still needed to localize the missing sponge, therefore obviating the time, cost, and radiation minimization benefits of otherwise avoiding the use of intraoperative x-rays.18 Additionally, the direct line of sight between the barcode scanner and the itemâ&#x20AC;&#x2122;s barcode label may be compromised by blood and fluid, thereby requiring manual wiping and removal of particulate before rescanning the sponge, which could lengthen the process and make it more cumbersome.33 Furthermore, the barcode label can separate from the sponge when irrigation warmers are used or in cases where bone cement is used, such as in orthopedic procedures.34

Radiofrequency Detection Technology Another option in preventing RSSs involves the use of radiofrequency (RF) detection technology (RF Assure Detection System X; Figure 2).35 Using a low-energy RF signal for the purpose of compatibility with existing OR equipment, this technology is engineered to detect misplaced surgical sponges before closing the wound.17 RF sponges have a small RF chip sewn into a pocket in the sponge.4 RF tags do not contain specific information, so the system cannot distinguish one sponge from another and cannot quantify the number of sponges; rather, its focus is to detect whether a sponge is in proximity to the receiver.17,35

The technology is used at the end of the procedure to supplement manual counts and to determine via detection whether a sponge has been retained inside the patient cavity.4 Visual proximity is not required with RF systems, and sponges with the passive RF tag can be detected when a receiver is within 16 to 24 inches of it.36 RF-based technologies typically use a detection mat (Antennae Array Body Scanner), a handheld wand (Room Scanner), or a combination of both.17 The Body Scanner, which is placed under the patient on the OR table, reduces the chance of human error with 1-button automatic scanning.17 The Body Scanner is used to quickly scan the patient (12 seconds) before completing the procedure to ensure that no surgical sponges are retained in the patient. In the event of a miscount, the Room Scanner is used to determine the location of an errant sponge, including within the patient if so used or the surrounding operating suite (eg, trash bags, linen bags).17,36 Per suggested manufacturer protocol, the Body Scanner is the first mode of scan (passive scan), with the ability to follow up with the Room Scanner (dynamic scan) as a secondary measure or if the Body Scanner detects the presence of an RF-tagged item. Additionally, the Room Scanner can be used for patient scanning, but is principally recommended as a supplement to the Body Scanner for morbidly obese patients. Furthermore, a recent RF component has been made available for clinical specialty use, the ArQ-Sphere Peripheral Scanner. This device offers in vivo detection that is ideally designed to address procedures where the Body Scanner may not be an option (eg, orthopedic and spine cases). The ArQ-Sphere enables clinicians to ensure the detection and removal of surgical sponges without compromising the integrity of the sterile field. The ArQ-Sphere offers motion-free scanning, and a triaxial overlapping detection field to create an optimal detection zone.37 Because the RF system does not require direct line of sight, as is otherwise needed with barcode-scanning technology, the RF system has the advantage of being able to detect RF-tagged sponges both inside and outside of the operative field. For example, the Room Scanner can be passed over the sterile field or linen, as well as trash bags, to locate a missing sponge.17,35 Unlike the barcode-scanning technology, RF-based technology can detect misplaced surgical sponges through blood, dense tissue, bone, and near metal.17,35 The localization features of this system have the potential to obviate the need for detection of missing sponges via intraoperative x-ray, thereby avoiding the associated costs, time, and radiation exposure of this technique, which are major advantages when compared with other adjunct technologies for the detection of an RSS.17

Clinical Studies Using Radiofrequency-Based Technology As reviewed here, several strategies designed to prevent RSSs (eg, manual counting, intraoperative radiography, and barcoded sponge systems) have drawbacks that limit their overall clinical usefulness. By contrast, the characteristics of the RF-based sponge-detection technology appear well suited for the prevention of RSSs in surgical patients relative to other strategies.

REPORT Several studies have investigated the clinical utility, time and resource utilization, and cost–benefit of this RF-based approach. For example, Steelman and colleagues performed a prospective, crossover, double-blind study in which 203 study participants (63% of whom were morbidly obese) reclined in a supine position on top of an RF Body Scanner.31 Four surgical sponges were sequentially placed on top of the torso in locations approximating the abdominal quadrants, or 4 surgical sponges were sequentially placed underneath the torso, and an RF wand was passed over the abdomen.31 The sensitivity and specificity of the RF detection scanner was 98.1% and 100%, respectively, and that of the Room Scanner was 100% and 100%, respectively, which the investigators noted was much higher than those of surgical sponge counts or published findings on the use of intraoperative radiographs to identify RSSs.31 Furthermore, the RF Room Scanner was slightly more sensitive for detecting sponges in morbidly obese patients than the RF Body scanner.31 The investigators noted that the RF scanning procedure to detect the presence of a sponge took less than 1 minute.31 Additionally, the RF Room Scanner located a sponge in a linen or trash receptacle without any line of sight.31 The investigators concluded that the use of the RF-based technology saved significant time and additional OR costs associated with resolving discrepant counts. With predicated use for the device, most implants, patient adornments, or appliances did not interfere with RF readings.4 Rupp and colleagues prospectively studied the use of the RF-based sponge detection technology versus standard counting protocols among 2,285 patients (Figure 3).38 Thirty-five surgical sponge miscounts (rate, 1.53%) resulting from standard counting procedures occurred.38 Several variables evaluated

were found to be associated with miscounts through statistical analysis: higher estimated volume of blood lost (P<0.0001), change of surgical team during the operation (P<0.0001), open surgical approach (P=0.004), higher number of laparotomy sponges (per 10 sponges opened) used (P<0.0001), unanticipated change in operative procedure during the surgery (P<0.0001), longer duration of operation (P<0.0001), emergency cases (P<0.0001), operations performed after 5 PM but before 7 AM (“after hours”; P=0.005), and operations occurring on a weekend or holiday (P=0.03).38 The investigators noted that the incorporation of the RF-based technology assisted in the resolution of a near-miss event (1 of 2,285) not detected by manual counting protocols and assisted in the resolution of the 35 surgical sponge miscounts resulting from standard counting procedures.38 Thus, they concluded that the incorporation of the RF-based spongedetection technology resulted in the prevention of RSSs over a 10-month period in a large surgical population.38 The study culminated with a questionnaire given to the circulating nurses at the completion of each procedure.38 The majority of respondents reported that confidence in the final count improved with the RF-based system was as follows: 95% responding agreed or strongly agreed; the RF system improved the time to resolve a count discrepancy (83% agreed); the RF system was easy to use (97% agreed); and the process of body cavity closure/operative conclusion was not prolonged by the use of the RF system (99.5% agreed).38

Time and Cost Savings Without adjunct detection technology, the time and cost associated with reconciliation of the surgical sponge count can be significant. One group of investigators retrospectively

42" 16"

The Blair-Port Wand X • Coverage area: Surrounding operating room environment

ConformPlus II Antenna Array Body Scanner • Clinical application: Torso

ARQ•Sphere Bi-Nodal Scanner • Clinical application: Extremities, head, neck, spine, and other specialty procedures

Figure 2. RF Assure Detection System X for the prevention of RSSs. RF, radiofrequency; RSSs, retained surgical sponges

REPORT analyzed 13,322 surgical cases.39 Accordingly, additional effort for reconciliation was required in 212 (ie, 1 in 63 procedures) surgical sponge counts, and of these, 143 were first closing counts and 63 were final closing counts.39 Type of sponges missing included 108 radiopaque 4×4s, 82 laparotomy sponges, and 4 episiotomy sponges.39 The most frequently reported steps taken for reconciliation were searching the sterile (77.4%) and nonsterile fields (58.5%).38 The time required to conduct such a search ranged from 1 to 90 minutes, with 9 searches taking longer than 30 minutes. Thus, the cumulative reported time required for reconciliation was 1,700 minutes.39 The results showed that 25% of cases required an x-ray with an average time of 30 minutes.39 Costs associated with this process were quantified as follows: time required to find the sponge at $62 per minute; time to administer intraoperative radiography at $62 per minute; and cost of x-rays, at $286 per x-ray.17,39 Using these costs, Steelman and colleagues found that the annualized operating

time spent on sponge counting reconciliation with the added expense of x-rays was $70,267.39 Additionally, the investigators concluded that the total annualized cost of searching for missing sponges and ruling out the presence of a retained sponge using radiography was $218,326.39 However, they also cautioned in their findings that these estimated costs are likely lower than actual costs. Hence, they noted that the staff likely did not report every search performed due to “documentation fatigue.”39 Additionally, the number of minutes for searches was at times recorded as “greater than 30” minutes and were treated as a 30-minute value in their analysis; moreover, an estimate of nonproductive OR time spent searching for a sponge at 50% was considered to be conservative.39 In their cost–benefit analysis of adopting an RF technology defined as having a Body Scanner that is placed under the patient on the OR table inclusive of a Room Scanner that is passed over the patient, Williams and colleagues reported

Conclusion of operation

Is the first manual count correct?

Yes

• Proceed with second manual count. • Proceed with body cavity closure.

Is the second count correct?

• Repeat count. • Proceed with RFDS scan.

Was the count discrepancy resolved?

Yes

• Proceed with RFDS scan. • Conclude closure of body cavity.

• Repeat count. • Begin search in areas of concealment. • Repeat body cavity search. • Proceed with RFDS scan. • If no resolution, obtain x-ray of body cavity.

• Proceed with second manual count. • Repeat RFDS scan. • Proceed with body cavity closure.

• Begin search in areas of concealment. • Repeat body cavity search. • Repeat RFDS scan. • Obtain x-ray of body cavity.

Figure 3. Algorithm of a counting process incorporating RF-based technology for the prevention of retained surgical sponges. RFDS, radiofrequency detection system Reprinted with permission. Rupp CC, et al. Effectiveness of a radiofrequency detection system as an adjunct to manual counting protocols for tracking surgical sponges: a prospective trial of 2,285 patients. J Am Coll Surg. 2012;215(4):524-533.

REPORT that 5 organizations that implemented the technology between 2008 and 2012 collectively demonstrated a 93% reduction in the rate of reported RSSs.17 Institutions that used the RF technology showed a significant reduction in OR time per case (16 minutes per procedure).17 The time saved was likely due to obviation of need for intraoperative radiography and less time searching for sponges. If RF technology is more efficient and effective in finding missing sponges, then the costs associated with operating suite time and x-rays should decline. To determine the annual savings in x-rays, the cost of a portable x-ray was derived from organizational data and multiplied by the estimated number of count discrepancies annually. The number of discrepancies was determined from an occurrence rate in the literature. To calculate the OR time saved, information on average time to reconcile a count discrepancy and the cost per minute of OR time was obtained from the literature. The following formula was used: Annual Savings in OR Time = number of minutes needed to reconcile a count discrepancy × the cost per minute × the number of discrepancies. Based on this formula, investigators calculated an average of 18 minutes (note: the model used 16 minutes as the average range) saved per case, while the cost savings in x-ray and operating suite time totaled $157,024.17,18

To determine the medical and legal costs avoided, information on the average cost of readmission and surgery, as well as malpractice claims, was obtained from the literature. The average number of RSSs annually was calculated from an occurrence rate in the literature, and the estimated costs avoided was determined at $441,534.17,30 Therefore, the 1-year cost– benefit analysis showed that the savings in x-rays and time spent in the OR and in the medical and legal costs (estimated at $598,558 annually) outweighed the cost of deploying RF technology ($191,352; Figure 4).17

Conclusion An RSS is a serious medical error associated with significant complications and high health care costs. This phenomenon is entirely preventable, but the current detection and avoidance of an RSS through manual counts and intraoperative x-rays are prone to error, present labor-intensive and time-consuming work, and are costly. By contrast, the use of RF detection-based technology as reported is quick and cost-effective in detecting RSSs, while providing efficiency-based cost savings to institutions. As recommended by the Joint Commission, AORN, and ACS, institutions should consider integrating the use of adjunct technologies, such as the RF-based system, into their sponge-counting process. Implementation should benefit hospitals and surgical facilities by avoiding complications and reducing overall costs.

< $191,352 Adoption of RF Technology

$157,024 Cost Savings

$441,534 Potential Costs Avoided

$598,558 Total Cost Savings + Cost Avoidance

Figure 4. Annual cost–benefit analysis for the use of RF technology for the prevention of retained surgical sponges. RF, radiofrequency Based on reference 17.

Disclosures: Dr. Boyd reported that he is a consultant for Covidien and RF Surgical Systems, Inc. Dr. Lottenberg reported that he is a consultant for Haemonetics, RF Surgical Systems, Inc., Synthes, and Teleflex. Disclaimer: This monograph is designed to be a summary of information. While it is detailed, it is not an exhaustive clinical review. McMahon Publishing, RF Surgical Systems, Inc., and the authors neither affirm nor deny the accuracy of the information contained herein. No liability will be assumed for the use of this monograph, and the absence of typographical errors is not guaranteed. Readers are strongly urged to consult any relevant primary literature.

July 2015

1. Gawande AA, Studdert DM, Orav EJ, et al. Risk factors for retained instruments and sponges after surgery. N Engl J Med. 2003;348(3): 229-235. 2. Hariharan D, Lobo DN. Retained surgical sponges, needles and instruments. Ann R Coll Surg Engl. 2013;95(2):87-92. 3. Dossett LA, Dittus RS, Speroff TS, et al. Cost-effectiveness of routine radiographs after emergent open cavity operations. Surgery. 2008; 144(2):317-321. 4. Steelman VM. Sensitivity of detection of radiofrequency surgical sponges: a prospective, cross-over study. Am J Surg. 2011;201(2): 233-237. 5. Gibbs VC, Auerbach AD. The retained surgical sponge. In: Shojania KG, Duncan BW, McDonald KM, Wachter RM, eds. Making Health Care Safer: A Critical Analysis of Patient Safety Practices. Evidence Report/Technology Assessment. No. 43. Rockville, MD: Agency for Healthcare Research and Quality, 2001:255-257. (AHRQ publication no. 01-E058.) 6. Zantvoord Y, van der Weiden RM, van Hooff MH. Transmural migration of retained surgical sponges: A systematic review. Obstet Gynecol Surv. 2008;63(7):465-471. 7. Egorova NN, Moskowitz A, Gelijns A, et al. Managing the prevention of retained surgical instruments: what is the value of counting? Ann Surg. 2008;247(1):13-18. 8. Wan W, Le T, Riskin L, et al. Improving safety in the operating room: a systematic literature review of retained surgical sponges. Curr Opin Anaesthesiol. 2009;22(2):207-214. 9. Cima RR, Kollengode A, Garnatz J, et al. Incidence and characteristics of potential and actual retained foreign object events in surgical patients. J Am Coll Surg. 2008;207(1):80-87. 10. Sturdy JH, Baird RM, Gerein AN. Surgical sponges: a cause of granuloma and adhesion formation. Ann Surg. 1967;165(1):128-134. 11. Lauwers PR, Van Hee RH. Intraperitoneal gossypibomas: the need to count sponges. World J Surg. 2000;24(5):521-527. 12. Johnson CD, Schmit GD. Peritneum and mesentery. In: Mayo Clinic Gastrointestinal Imaging Review. Rochester, MN: Mayo Clinic Scientific Press; 2005. 13. Department of Health and Human Services, Centers for Medicare & Medicaid Services. CMS proposes additions to list of hospital-acquired conditions for fiscal year 2009. http://www.cms.gov/Newsroom/MediaReleaseDatabase/Fact-Sheets/2008-Fact-Sheets/Items/2008-04-14. html#_ftn3. Accessed May 20, 2015. 14. Stone PW, Braccia D, Larson E. Systematic review of economic analyses of health care-associated infections. Am J Infect Control. 2005;33(9):501-509. 15. Carrol AE, Parul DP, Buddenbaum JL. The impact of defense expenses in medical malpractice claims. J Law Med Ethics. 2012;40(1):135-142. 16. Lincoln T, Public Citizen. Medical malpractice payments sunk to record low in 2011: skyrocketing healthcare costs and rampant medical errors discredit the promises put forth by advocates of tort reform. July 2012. www.citizen.org/documents/npdb-report-2012.pdf. Accessed May 20, 2015. 17. Williams TL, Tung DK, Steelman VM, et al. Retained surgical sponges: findings from incident reports and a cost-benefit analysis of radiofrequency technology. J Am Coll Surg. 2014;219(3):354-364. 18. Greenberg CC, Diaz-Flores R, Lipsitz SR, et al. Bar-coding surgical sponges to improve safety: a randomized controlled trial. Ann Surg. 2008;247(4):612-616.

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SR1525

References

CO-00566

REPORT