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EXTENDED HERNIA COVERAGE 2021
August 2021
AHS Presidential Address
It’s Just a Hernia, Until It’s Not By DAVID CHEN, MD
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Talking With Your Patients About Hernia Mesh By VICTORIA STERN
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n 2013, Susan Eller felt a sudden pain in her groin. After months of physical exams and an exploratory procedure provided no answers, she finally identified the source: a femoral hernia. That May, Eller had her hernia repaired with polypropylene mesh. Her general surgeon said she’d be back on the tennis court in a few weeks. But instead, Eller’s groin pain intensified after her surgery. Over the next two years, she had a triple neurectomy, mesh removed and two tissue repairs after her hernias recurred. By 2015, still suffering from chronic pain, she needed an extensive abdominal wall reconstruction and had a large piece of polypropylene mesh placed across her midsection. That, Eller said, is when her problems became systemic: In addition to debilitating pain, she developed an itchy rash, irritable bowel syndrome and nausea. Over several months, she lost 40 pounds. In 2017, Eller flew to Los Angeles to see a hernia specialist with particular expertise in the female anatomy. continued on page 14 OPINION
The History of Inguinal Hernia Surgery
y surgeon friend asked me today ay if I preferred a day of straightforrward inguinal hernia repairs or a day of dealing with challenging disaster cases. s. I quickly responded that complicated ed patients are intrinsically easier because use the expectation levels all around are much more forgiving. An inguinal hernia repair is like a cholecystectomy—anything less than perfection is deemed a failure. That, and anatomy and probability dictate that if you operate enough, perfection is impossible. In the course of a year, I see approximately 250 patients who come to the Lichtenstein Amid Hernia Clinic at UCLA with complications of inguinal hernia repair—neuropathic pain, mesh pain, recurrence, fistula, infection. Invariably, one of the main questions asked is “Was anything done wrong?” This undercurrent has become more prevalent in this climate of mesh fear. While I have read thousands of operative reports and can predict suboptimal operative factors, I always remind patients that 1) surgeons operate with the intention of helping patients; 2) the patient before you and after you who had the same operation are likely doing fine; and 3) complications happen to every surgeon. What does surgical “science” tell us about optimal technique in inguinal hernia repair? Recurrence rates in the mesh era have dropped into the 2% to 3% range. Chronic pain rates, realistically, are over 5%, affecting patients’ quality of life. Minimally invasive laparoscopic and robotic techniques have matured to provide excellent outcomes with benefits of early recovery and lower rates of chronic pain. However, there is no one-size-fits-all in hernia, with many benefiting from a MIS [minimally invasive surgery] approach, some patients best served with an open Lichtenstein repair, others with a Shouldice tissue repair, and some with watchful waiting. Especially in hernia surgery, patient outcomes are most significantly tied to the surgeon—the one primary variable that
By EDWARD FELIX, MD, and TYLER ROUSE, MD
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ne may wonder why they should read a review detailing the history of hernia repair. This is a question I asked myself when my chief, Professor Lloyd Nyhus, demanded it my of his residents. As a novice surgeon, I didn’t understand how learning the history of an operation could make me a better surgeon. But with time, I came to realize that by studying the history of a procedure, I would understand the principles that must be applied for success. Inguinal herniorrhaphy techniques have developed through the ages as knowledge of groin anatomy has improved. Through an appreciation of this evolution, modern approaches incorporating the lessons of the past have become safer and more effective. A failure to understand this history only results in repeating the mistakes of the past. The purpose of this review is to aid the modern hernia surgeon in the quest to perform a better inguinal hernia repair, no matter the choice of approach, whether it be open anterior or posterior, primary repair or mesh reinforced, laparoscopic or robotic. continued on the following page
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IN THIS ISSUE 14 Prophylactic Mesh: Have We Identified the Right Patient? Infection-Related Mesh Explantation Most Common in Ventral Hernia 16 Surgeons' Lounge: Component Separation For Abdominal Wall Reconstruction 18 Journal Watch: Recently Published Articles In Hernia Repair
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OPINION
GENERAL SURGERY NEWS / AUGUST 2021
History of Inguinal Hernia Surgery continued from the previous page
Hernia and the Ancients The word “inguinal” derives from the Latin word for groin, “inguen,” and repair of a hernia has been called a herniorraphy. The etymology of the word “hernia” originates from the Greek word “hernios,” meaning an offshoot or bud, and the suffix “-rrhaphy” comes from the Greek word “rhaptein,” meaning to stitch or sew. Today, we use the term “hernioplasty” instead of herniorraphy because of the incorporation of a mesh patch into the repair. There is evidence of inguinal hernias dating back to the ancient Egyptians, Phoenicians and Greeks, who described hernias and ways of treating them. In the mummified remains of the pharaoh Merneptah (1215 b.c.e.), a large wound in the groin with the scrotum separated from the body may be evidence of the earliest attempt at hernia surgery. The writings of the Roman physician Celsus are some of the earliest accounts of the hernia and its repair, dating back to the first century c.e. His approach of closing the external ring was the best the medical world had to offer for nearly two millennia. Removal of the testicle became a routine part of the operation for centuries, as advocated by Galen. In Europe in the Middle Ages, French surgeon Guy de Chauliac (1298-1368) borrowed heavily from the writings of the famous Arabic surgeon, Albucasis, proposing six different treatments for inguinal hernia. His surgical textbooks became the standard for another 300 years.
Hernia Repair In the Renaissance The organized and detailed study of hernias began during the Renaissance, with the renowned French surgeon Ambroise Paré. In his book, “The Apologie and Treatise,” Paré provided a detailed account of the hernia operation, describing how the hernia contents should be reduced into the abdominal cavity and how the peritoneum should be sewn up. Surgical approaches, however, were limited by a lack of understanding of anatomy until the mid-1700s, sometimes called “the Age of Dissection,” or the Anatomic Era. Many famous surgeons made contributions to the understanding of hernias, including John Hunter, who in 1790 pointed out the congenital nature of some indirect hernias. English surgeon Sir Astley Cooper played a large role in the understanding and treatment of hernias. Not only did Cooper describe venous obstruction as the first step in the cascade of events in a strangulated hernia that leads to necrotic bowel, but it was his monograph in 1804 that had the largest impact. In it,
he described the fascia transversalis, and showed that it was the main barrier to herniation. He also showed its extension behind the inguinal ligament into the thigh as the femoral sheath and the pectineal part of the inguinal ligament, now known as Cooper’s ligament. Many others contributed to our understanding of groin anatomy, including Hasselbach, Camper, Scarpa, Richter and Gimbernat. Their names live on in anatomic components of the inguinal region. Several novel techniques were tried. William Wood, an English surgeon, took the hernia sac, folding it back on itself and using it as a sort of plug at the internal ring. The external ring would be sutured closed. A first assistant to Theodor Billroth in Vienna, Vincenz Von Czerny, simply tied off the hernia sac, and sutured closed the external ring without opening the canal—essentially the same operation as Celsus, from the first century. Unsurprisingly, these techniques did not stand up to scrutiny, with most patients experiencing a recurrence. In fact, like in ancient times, many surgeons in the 1800s left the wound open to close by secondary intention in the hope this scar would strengthen the repair. This was known as the McBurney operation, named after American surgeon Charles McBurney.
Hernia Repair Enters The Modern Era The big change came to inguinal hernia repair because of a collision of events. In 1867, surgeon Edoardo Bassini was stabbed with a bayonet while serving as a soldier in the war to unify Italy. While undergoing a prolonged recovery from his injuries, he studied anatomy at the University of Parvia. Armed with his new understanding of the importance of anatomy, Bassini traveled to train with the masters of the period: Theodor Billroth in Vienna, Bernhard Langerbeck in Berlin, and Joseph Lister in London. He became the director of surgical pathology at the University of Padua in 1882, and undertook detailed dissections of the groin region. With his newly acquired understanding of anatomy, Bassini developed the first modern approach to inguinal hernia repair. He devised a surgical method that involved dissection of the layers of the inguinal canal and then reconstruction of the posterior wall of the inguinal canal. By 1889, Bassini had operated on 274 hernias, and collected data on 216 patients over almost five years. He identified eight recurrences (a rate of 4%), 11 postoperative infections (5%), and no reported deaths among the 251 nonstrangulated repairs. To put that into contemporary perspective, the Billroth
A 15th-century gouache painting depicting Guy de Chauliac giving an anatomy lesson. Source: Wikimedia Commons
clinic at the time had a mortality rate of 6% and a recurrence rate of 33%. The study of anatomy continued to play an important role in the history of modern hernia repair. Chester McVay, while still a student at Northwestern University, in Chicago, published three seminal papers on the anatomy of the inguinal region with his teacher, the anatomist Dr. Barry Anson. In 1939, as an intern at the University of Michigan Hospital, McVay published a paper entitled “A Fundamental Error in the Bassini Operation for Direct Inguinal Hernia.” Although he went on to spend his entire career in a small town in South Dakota, McVay made a major contribution to improving the understanding of groin anatomy and altered Bassini’s repair accordingly. The repair he created has been called the Anson-McVay repair. In 1945, a Canadian surgeon, Earle Shouldice opened an outpatient hernia clinic applying the principles of the Bassini repair but further modifying it by adding an additional suture line to the reconstruction of the posterior wall. The results of his clinic were later published extensively by surgeon Robert Bendavid, establishing a new standard for recurrence, at 1%.
Mesh Reinforcement Although hernia repair based on anatomic principles was established following Bassini’s work, hernia recurrence and disability following repair remained problems. The concept of a reinforced repair was introduced to resolve these issues. The earliest attempts date back to Henry Orlando Marcy, a Boston surgeon, who recommended kangaroo tendon in 1887. It was not until Wallace Carothers, working for Dupont, discovered a
method for creating synthetic polymers in 1935, that led to Melick using nylon as a reinforcement. By the 1960s, Dr. Richard Newman had performed more than 1,600 inguinal hernia repairs using polypropylene. In 1968, in Los Angeles, Dr. Irving Lichtenstein first introduced the plug technique for femoral and recurrent inguinal hernia repair, using a rolled cylindrical or ‘cigarette’ Marlex mesh plug. This idea evolved to hand-rolling more of a cone shape, and even to preshaped mesh inserts. In 1987, Lichtenstein published a series of patients with repairs using Marlex mesh. This experience involved more than 6,000 patients followed from two to 14 years, with a recurrence rate of 0.7%. His technique became known as a “tension-free” repair and was popularized by Dr. Parvez Amid, who went on to modify and teach the approach. Using this new approach, inguinal hernia repair became an outpatient procedure that could be performed under local anesthesia. At approximately the same time, Dr. Arthur Gilbert developed a plug-and– patch, tension-free approach at his hernia clinic in Florida. Although extremely successful, the approach was later modified by Dr. Gilbert into the Prolene mesh system, which reinforced both sides of the floor. In New Jersey, Dr. Ira Rutkow, who studied Gilbert’s technique, popularized a version of the plug-and-patch and taught his method extensively. Both Gilbert’s and Rutkow’s repairs, along with Amid’s modifications of the Lichtenstein approach, remain the basis for most open inguinal hernia repairs performed today. The study of the anatomy of the groin led another group of surgeons to approach inguinal hernia repair in a totally new
AUGUST 2021 / GENERAL SURGERY NEWS
direction—from a posterior approach. It goes back to 1876, when Annandale of Edinburgh presented his concept of a preperitoneal approach and then by Trait in 1891, who reported an intraperitoneal approach. Cheatle in 1921, and later Henry in 1936, proposed a posterior approach for inguinal and femoral hernias, but it wasn’t until the late 1950s that Lloyd Nyhus and his associates popularized a posterior approach for inguinal hernias, including direct ones. It was Algerian surgeon Rene Stoppa, who, in 1972, introduced the concept of an open posterior approach with a mesh prosthesis without fascial closure—the technique that became the basis of minimally invasive repairs. Dr. Raymond Read reported a mesh repair sutured in place with an opening for the cord structures in 1979, but because of failures through the slit made for the cord and at the sutured edges, Professor George Wantz began using a version of the Stoppa repair with a giant mesh covering the entire myopectineal orifice.
The Laparoscopic Approach In 1979, inguinal hernia repair was forever altered when South African surgeon, Ralph Ger, practicing in New York City, applied a posterior clip approach laparoscopically that he had previously performed in an open approach. His work was reported in the Annals of the Royal College of Surgeons of England in 1982 (64[5]:342344), but failed to gain a following until laparoscopy for general surgeons grew in popularity with the advent of laparoscopic cholecystectomy in 1989. Many surgeons worldwide then began to investigate how a laparoscopic approach based on previous posterior as well as anterior tension-free approaches could be performed. Some of the first were Dr. Leonard Schultz in Minnesota, with his plug-and-patch transabdominal laparoscopic approach, and Dr. Robert Fitzgibbons in Nebraska, as well as Dr. Morris Franklin in Texas, with their own intraperitoneal onlay mesh (IPOM) approaches. These techniques fell out of favor, however, due to complications with the plugs, the intraperitoneal mesh or recurrence because of failure to adhere to the principles previously established by the open posterior approach. Two different approaches, the transabdominal preperitoneal (TAPP) and the totally extraperitoneal (TEP), both emulating the open posterior approaches of Nyhus, Wantz and Stoppa, soon became the basis for today’s minimally invasive inguinal hernia repair. Surgeons working independently, including Drs. Ferzli, McKernan, Voeller, Payne, Arregui, Duncan and myself (Felix), as well as many others, became reluctant pioneers, developing techniques and instruments necessary to duplicate the concepts of the open posterior approach. In 2009, Dr. Jorge Daes, an accomplished laparoscopic
EXTENDED HERNIA COVERAGE 2021
surgeon in Colombia, introduced E-TEP, which was a variation of the TEP procedure, allowing surgeons to apply the laparoscopic approach to patients in whom visualization is restricted because of limited space. The debate on whether the TAPP, TEP or E-TEP approach is best; whether fixation is necessary; or what mesh should be used began, and has continued until today. What became apparent from all the different surgeons and slightly different techniques, however, was that there are certain underlying principles, steps or rules that should be followed
for the minimally invasive repair to have both short- and long-term success. These concepts were published in the Annals of Surgery, 25 years after the first successful laparoscopic repairs were reported (Ann Surg 2017;266[1]:e1-e2).
Robotic Hernia Repair In 1999, the first robotic TAPP (R-TAPP) inguinal hernia repair was performed in Europe by Dr. Jacques Himpens, and in the United States by Dr. Barry Gardiner. Most of the early R-TAPP procedures, however, were reported in conjunction with robotic prostatectomy. By
2015, reports of stand-alone R-TAPP were published. On the International Hernia Collaboration (IHC), a social media platform for hernia surgeons established in 2012, the growth of robotic inguinal hernia repair was stimulated through video education and collaboration. Pioneers of the robotic approach, like Dr. Conrad Ballecer from Arizona, presented their techniques and were critiqued by surgeons who had extensive experience with the laparoscopic approach. The techniques used to perform R-TAPP soon came to mimic those of laparoscopic TAPP, and continued on page 5
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IN THE NEWS
GENERAL SURGERY NEWS / AUGUST 2021
Prophylactic Mesh: Have We Identified the Right Patient? By MONICA J. SMITH
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s research supporting the use of prophylactic mesh to prevent incisional hernia continues to grow, the focus of managing that surgical complication may change from treatment to prevention. The key to shifting this pendulum is identifying the right patients. Are we there yet? “I will caveat the answer with ‘we’re working on it and we’re close,’” said William Hope, MD, the program director of the general surgery residency program at the Novant/New Hanover Regional Medical Center, in Wilmington, N.C., speaking at the 2021 virtual Abdominal Wall Reconstruction Conference. When the European Hernia Society (EHS) published its recommendation on prophylactic mesh augmentation (PMA) in 2015 (the latest to date), there weren’t enough data from sufficiently large trials for the society to strongly support the use of PMA in all patients meeting the criteria for particular risk groups. Since then, things have changed. A year later, researchers led by Filip Muysoms, MD, in Belgium reported the findings of a randomized controlled trial of 120 patients with abdominal aortic aneurysms. At two years’ followup, the incisional hernia rate in patients who underwent primary suturing was
28%, while none of the patients with a PMA (recto-rectus, large-pore PPE) developed an incisional hernia (Ann Surg 2016;263[4]:638-645). “This is probably the easiest high-risk group to identify, and I think we would all agree on PMA in patients with abdominal aortic aneurysms,” Dr. Hope said. This was followed by the PRIMA trial, which included two groups of high-risk patients—those with abdominal aortic aneurysms and those with obesity (body mass index ≥27 kg/ m2)—as well as two mesh placement techniques, onlay and sublay (Lancet 2017;390[10094]:567-576). “They reported that you definitely decrease the chance of an incisional hernia by placing a mesh. This was really the first time this was shown with an onlay, and at least in prophylaxis, the onlay did as well as the sublay,” Dr. Hope said. Mesh has also been investigated in the setting of parastomal hernia prevention. In 2018, the EHS recommended use of prophylactic synthetic nonabsorbable mesh on construction of the end colostomy. “This was a strong recommendation based on a lot of data,” Dr. Hope said. A follow-up systematic review and meta-analysis that found PMA reduced the risk for incisional hernia after stoma reversal further supported the EHS’s recommendation (Hernia
2019;23[4]:733-741). Still, among the surgical interventions aimed at preventing incisional hernia (e.g., using minimally invasive techniques, minimizing potential wound complications and using optimal suturing techniques), PMA is the most controversial: placing mesh to prevent an outcome that hasn’t happened. “The risk‒benefit has to be carefully considered and balanced,” John Fischer, MD, told General Surgery News. “It’s similar to the dilemma we face in hernia repair: We know there’s a risk of recurrence if we don’t use mesh to support the repair, but we’re also putting mesh into patients who won’t develop a recurrence.” Another reason PMA is controversial is that much of the data supporting its
use come from European trials, and it’s not certain that the findings of those trials are applicable to patients in the United States. “The PRIMA trial shows a nice benefit to using mesh, but those patients really aren’t the same as the patients we see. We had the same issue with the STITCH trial, which showed the benefit of closing with very small bites and lots of suture: Is it generalizable?” said Dr. Fischer, an associate professor of surgery at the University of Pennsylvania, in Philadelphia. Also worth noting is that no mesh has been indicated for use as a prophylactic against incisional hernia. “So it’s really an off-label use. You’d be using your own clinical judgment,” Dr. Fischer said.
‘The risk–benefit has to be carefully considered and balanced. It’s similar to the dilemma we face in hernia repair: We know there’s a risk of recurrence if we don’t use mesh to support the repair, but we’re also putting mesh into patients who won’t develop a recurrence.’ —John Fischer, MD
Infection-Related Mesh Explantation Most Common in Ventral Hernia By ETHAN COVEY
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ates of mesh explantation due to infection following hernia surgery, while low, are highest among patients receiving ventral hernia repair, according to findings from a recently published study. The report reinforces the importance of optimizing surgical approaches and working to eliminate surgical site infections (SSIs) because outcome rates varied according to the type of hernia operation, baseline patient characteristics and effectiveness in preventing infection (J Am Coll Surg 2021;232:872e881). “This is the largest study on mesh infection, conducted in over 100,000 patients over five years with a lot of interesting findings,” said study author Kamal M. F. Itani, MD, the chief of surgery at the VA Boston Health Care System. “Unlike others in the literature, this study looks at ventral, umbilical and inguinal hernias, and gives specifics about each operation.” Dr. Itani and his colleagues conducted the retrospective study using data
from the Veterans Affairs Surgical Quality Improvement Program, as well as chart reviews of veterans who underwent abdominal or groin hernia repair that included synthetic mesh implantation, during 2008-2015.
‘Despite the devastating effect of mesh infection, the risk of recurrence outweighs the risk of infection. By driving the risk of infection lower, we can further decrease the risk–benefit ratio of placing a mesh.’ —Kamal M. F. Itani, MD The primary outcome of the study was to identify how often mesh explantation, caused by infection, occurred within five years following surgery. SSIs were defined as the presence of VA Surgical Quality Improvement Program‒reviewed superficial, deep incisional or organ/ space SSIs within 30 days of the index operation.
A total of 103,869 hernia operations were tracked, of which 74.3% were inguinal, 10.7% were umbilical and 15.0% were ventral. While the incidence of mesh explantation due to infection was low, occurring in 0.3% of the patients, rates were highest among patients who underwent ventral repair (1.5%), followed by those in the umbilical (0.6%) and inguinal (0.1%) groups. Similarly, SSIs were rare yet placed the patient at a higher risk for mesh explantation. Among patients with SSIs, mesh removal occurred in 29.2% of those with deep wound infections, 22.4% with organ/ space SSIs and 6.4% with superficial SSI. Staphylococcus aureus was the most common causative organism in SSIs. While SSIs occurred within the first 30 days after the procedure, mesh explantation did not take place until a median of 208 days from the index hernia surgery. “This means that surgeons are attempting various maneuvers at salvaging the mesh over a period of seven months,” Dr. Itani noted. “We are very interested in looking at what happens between
index hernia operation and mesh explantation, what measures surgeons are taking to salvage the mesh and how often they are successful.” The researchers found that many factors influenced whether a patient was more likely to require mesh explantation. These included obesity (odds ratio [OR], 1.7), longer operations (OR, 1.83), and contaminated wound sites (OR, 2.27). Additionally, open surgery was more likely to lead to explantation than were laparoscopic procedures. “Most hernia surgeries are elective and patients’ conditions should be optimized prior to undertaking these operations,” Dr. Itani said. “All measures of SSI prevention should be strictly observed to prevent a postoperative SSI.” Yet, he stressed that although the risks for SSIs and related mesh explantation are real, they shouldn’t cloud understanding of the benefits of mesh usage. “The standard of care in elective hernia surgery calls for the placement of a mesh,” Dr. Itani said. “The risk of hernia recurrence is much higher without a mesh. Despite the devastating effect of
AUGUST 2021 / GENERAL SURGERY NEWS
But researchers are homing in on risk stratification and patient identification tools that could eventually render PMA much less controversial. Five years ago, Dr. Fischer and his colleagues showed that a preoperative risk assessment could be used to predict which patients were more likely to develop an incisional hernia (Ann Surg 2016;263[5]:1010-1017). “There are clearly high-risk patients who will develop hernias at a higher rate and sooner than others, and I think this was the first step into trying to figure out the patient populations this could happen to,” Dr. Hope said. More recently, Dr. Fischer and his colleagues identified procedure-specific risk factors and developed an algorithm that can be used at the point of care to predict which patients might develop an incisional hernia (Ann Surg 2019;270[3]:544-553). “Ultimately, this led to the Penn Hernia Risk Calculator, which is an app you can download to your smartphone and enter patient characteristics. This is something we can use quickly and easily in discussions with our patients about risk strategy and risk stratification, and I think it will go a long way to help surgeons,” Dr. Hope said. “I’m not sure there will ever be a universal definition of what is high risk, but the calculator and support tools that are coming as we gain more information about risk factors are going to be really helpful,” he said. ■
EXTENDED HERNIA COVERAGE 2021
Hernia History continued from page 3
reported outcomes were similar. The robotic approach, however, allowed more surgeons to adopt a minimally invasive approach, and many applied it to situations that were extremely difficult for conventional laparoscopy—such as post‒radical prostatectomy, mesh removal and giant scrotal hernias. Inguinal hernia repair has come a long way from amputation to reconstruction and from large open incisions to minimally invasive approaches
assisted by robots. What has been constant through this evolution is that the repairs need to be based on anatomic considerations and that certain principles need to be applied. When we look closely at the history of inguinal hernia repair just presented, we find that the steps taken to perfect the current minimally invasive repairs duplicate those taken by surgeons who developed open approaches. It is my hope that surgeons will continue to study the past to guide their efforts to advance the safety and efficacy of repairs they presently perform and
ones they may develop in the future. A failure to understand our history will result in repeating the mistakes of the past. We do not need to rediscover the wheel, but rather improve upon it. ■ —Dr. Felix is a general surgeon from Pismo Beach, Calif., and a member of the editorial advisory board of General Surgery News. Dr. Rouse is associate anatomical pathologist, Huron Perth Healthcare Alliance, Stratford, Ontario, and adjunct professor, Department of Pathology and Lab Medicine, Western University, London, Ontario, Canada.
mesh infection, the risk of recurrence outweighs the risk of infection. By driving the risk of infection lower, we can further decrease the risk‒benefit ratio of placing a mesh.” According to William J. O’Brien, MS, of the Center for Healthcare Organization and Implementation Research at the VA Boston Healthcare System, who was a co-author of the study, the research also highlights the importance of such large, detailed looks at surgical risk factors. “This study speaks to the importance of having a validated, high-quality surgical registry that allows us to study postoperative complications that are infrequent yet have severe consequences for the patient’s long-term health,” Mr. O’Brien said. “The VHA is one of the few institutions where researchers can not only identify a large national surgical population, but also combine rich clinical data to understand what is happening with these patients over a long follow-up ■ period.” This work was supported by an investigator-initiated award from Pfizer.
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GENERAL SURGERY NEWS / AUGUST 2021
Component Separation for Abdominal Wall Reconstruction
Welcome to the August issue of The Surgeons’ Lounge. In this issue, Lisandro Montorfano, MD, the chief general surgery resident at Cleveland Clinic Florida, in Weston, interviews Andres Mascaro Pankova, MD, from the Department of Plastic and Reconstructive Surgery at Cleveland Clinic Florida, about component separation for abdominal wall reconstruction. Dr. Pankova provides up-to-date responses to the most common questions regarding component separation for abdominal wall reconstruction. Also in this issue, another installment of “The Instrument, the Name” features the Titan CSR (Cestero Surgical Retractor; ASR Systems, Inc.; www.asrsystemsinc. com). We look forward to our readers’ questions, comments and interesting cases to present. Sincerely, ly, Samuel Szomstein, MD, FACS CS Editor, The Surgeons’ Lounge nge Szomsts@ccf.org
In some cases, it is not possible to approximate the abdominal muscle wall edges, and in these cases mesh is almost always mandatory as a bridge to achieve abdominal wall integrity. —Andres Mascaro Pankova, MD
Dr. Montorfano: What is component separation? to approximate both edges of the muscle. In What are the different techniques of component some cases, it is not possible to approximate separation for abdominal wall reconstruction? the abdominal muscle wall edges, and in these Dr. Pankova: Component separation involves cases mesh is almost mandatory as a bridge to Lisandro separating and advancing certain layers of the achieve abdominal wall integrity. abdominal wall muscle, lengthening them so that Montorfano, MD Selection of mesh for ventral hernia repair the muscles on the right and left sides can be and abdominal wall reconstruction can be chalbrought closer to the midline for sufficient closure. lenging. Since the adoption of a tension-free This technique restores the structural and functionmesh repair, the recurrence rates and outcomes al integrity of the abdominal wall and aids in the after ventral hernia repair have substantialaesthetic appearance. Depending on the muscle(s) ly improved. In cases where the field is condivided, the classic techniques of component sepataminated, a biologic acellular dermal matrix ration can be broadly categorized into anterior and (ADM) mesh is the recommended option. If posterior. Anterior component separation divides Andres Mascaro the field is clean and uncontaminated, a synPankova, MD the external oblique muscle lateral to the linea semithetic nonabsorbable mesh can be used. lunaris and separates the external oblique from the underlying internal oblique muscle. This can be approached Dr. Montorfano: What is your opinion about via open or minimally invasive techniques. Minimally inva- onabotulinumtoxinA (Botox, Allergan Aesthetics) to sive techniques are performed by making a small incision at allow muscles of the abdominal wall to reapproximate? the level of the linea semilunaris and dividing the external Dr. Pankova: Recently, botulinum toxin A (BTA) has oblique fascia with raised skin flaps. arisen as a potential tool in the surgeon’s armamentarium The posterior component separation occurs just medial for abdominal wall reconstruction. Treatment of a muscle to the linea semilunaris, and the transversus abdominis is with BTA results in functional denervation within two days released by dividing the fascia and muscle insertion to the with peak effect after four to six weeks, leading to musposterior layer. This allows a wide plane of preperitoneal cle atrophy and paresis. The broad range of indications for dissection and advancement. BTA has raised the potential for its use in abdominal wall Similar to the anterior component separation, a poste- reconstruction. The application of BTA for this purpose is rior component separation is undertaken using the same considered off-label by the FDA. There are promising data approaches. regarding the use of BTA. BTA appears to be a safe and useful adjunct to achieve primary fascial closure in comDr. Montorfano: How does component separation plex abdominal wall reconstruction with loss of domain. By apply to abdominal wall hernia repair? What are the reversibly inducing flaccid paralysis of the lateral abdominal indications for component separation? wall, BTA allows for closer apposition of the midline fascia, Dr. Pankova: Complex abdominal wall hernias are more reducing tension on the repair and decreasing intraabdomidifficult to repair and often have a higher rate of recurrence nal pressure, both significant risk factors for recurrence. and postoperative complications. To repair these complex and sometimes recurrent hernias, component separation is Dr. Montorfano: Could you mention some new plastic usually one of the techniques of choice. It is particularly use- and reconstructive surgery advances in abdominal wall ful when there is loss of domain, and a conventional primary reconstruction? hernia repair cannot be performed. The advantage is basiDr. Pankova: The evolution and success of intestinal cally the ability of completely reestablishing the abdominal and multivisceral transplantation over the past 20 years has wall integrity in a dynamic fashion using native tissue. The raised the issue of difficult, or even impossible, abdomidisadvantages are the possible surgical complications asso- nal closure. Abdominal wall transplant is a type of comciated with these types of procedures. When a component posite tissue allograft that can be utilized to reconstitute of the abdominal wall is released, the area may potentially the abdominal domains of patients who undergo intesbecome weakened, and the patient may develop a bulge or tinal transplantation, and the results are encouraging. another hernia in the location in the future. This is a complex procedure that requires microsurgical techniques and immunosuppressive drugs after surgery. Dr. Montorfano: Is patient selection important at the It is being developed and may become an option in the near time of performing a component separation? Who is the future for large complex abdominal wall defects. ■ ideal candidate for component separation techniques? Dr. Pankova: Yes, absolutely. The ideal candidate is a Suggested Reading patient who does not smoke, has a normal body mass index Albright E, Diaz D, Davenport D, et al. The component separaand no previous abdominal wall radiation. Unfortunately, tion technique for hernia repair: a comparison of open and endothis is not always possible. More important is the integrity of scopic techniques. Am Surg. 2011;77(7):839-843. the abdominal wall. Previous surgeries may potentially com- Levi DM, Tzakis AG, Kato T, et al. Transplantation of the promise the integrity of the rectus and lateral muscles and, abdominal wall. Lancet. 2003;361(9376):2173-2176. as such, the ability of performing a component separation. Pauli EM, Rosen MJ. Open ventral hernia repair with component separation. Surg Clin North Am. 2013;93(5):1111-1133.
Dr. Montorfano: Do patients undergoing component separation need mesh reinforcement? If so, what type of mesh can be used for this purpose? Dr. Pankova: There are data to support that use of mesh in association with muscle release and flap advancement has a lower rate of hernia recurrence, even when it is possible
Sailes FC, Walls J, Guelig D, et al. Synthetic and biological mesh in component separation: a 10-year single institution review. Ann Plast Surg. 2010;64(5):696-698. Weissler JM, Lanni MA, Tecce MG, et al. Chemical component separation: a systematic review and meta-analysis of botulinum toxin for management of ventral hernia. J Plast Surg Hand Surg. 2017;51(5):366-374.
AUGUST 2021 / GENERAL SURGERY NEWS
EXTENDED HERNIA COVERAGE 2021
The Instrument, the Name
The TITAN CSR™ (Cestero Surgical Retractor) By Bora Kahramangil, MD ((PGY-4),) and Lisandro Montorfano, MD (chief resident), Cleveland Clinic Florida, in Weston new retractor is especially promising The T TITAN CSR has rauma surgery is uniquely for trauma surgeons in both civilian been formally deterpositioned among genbee and military practices, there is also mined to be a Class eral surgical specialties, as es, mi potential benefit for other surgical I, 510(k)-exempt surgeons routinely have ve 5 Figure 1. specialties that routinely perform lapamedical device to operate on patients s me The TITAN CSR. rotomies, such as general surgery, by the FDA, and in extremis. This is furrt colorectal surgery, surgical oncology, is in clinical use at ther compounded by the vascular surgery, transplant surgery University Hospital in limited resources in combat ombat Univer Figure 2. The TITAN CSR achieving and hepatobiliary surgery. San Antonio. Although this trauma surgery. When pern Anto exposure of abdominal structures. forming a damage control laparotomy, ntrol there are only two goals: to achieve hemostasis and control contamination. The time in the OR must be limited to the absolute minimum necessary to achieve these goals. Following damage control, the patient must be expeditiously transferred to the ICU for continued resuscitation, or to a trauma center in combat settings. Due to the time-sensitive nature of trauma surgery, table-mounted retractors with long setup times are rarely appropriate for use in the trauma patient population. An ideal trauma retractor would be a multiarm self-retaining retractor, which does not require any table mounting. The TITAN CSR (ASR Systems, Inc.; www.asrsystemsinc.com) was designed by Ramon Cestero, MD, with this principle in mind. This retractor has four intraabdominal blades with two blades retracting on each side of the midline abdominal incision (Figure 1). Modular arms expand laterally on this four-blade frame with the resulting retraction, both establishing the lateral separation of the abdominal wall and stabilizing the retractor in place. The four-blade configuration forms a stable base to prevent unintended rotations. Additional blades can be attached onto the modular arms to expose deep abdominal structures. The ring attachments are compatible with the Bookwalter (Symmetry Surgical) blades, facilitating adoption of the TITAN CSR in hospitals already using the Bookwalter retractor, with minimal added cost. Furthermore, the TITAN CSR ring height is adjustable, and the four-blade frame can be adapted to different incision lengths ranging from For more information or to place an order, please contact: Indications United States, Canada, Asia, Pacific, Latin America SurgiMend is intended for implantation to reinforce soft tissue where weakness 13 to 37 cm, allowing the use of this USA 877-444-1122 866-800-7742 fax exists and for the surgical repair of damaged or ruptured soft tissue membranes. retractor in patients with different International +1 617-268-1616 + 1 617-268-3282 fax surgimendsales@integralife.com SurgiMend is specifically indicated for: types of body habitus. Visit us at: SurgiMend.com • Plastic and reconstructive surgery. In cadaveric studies, the TITAN • Muscle flap reinforcement. • Hernia repair including abdominal, inguinal, femoral, diaphragmatic, scrotal, SurgiMend, Integra and the Integra logo are registered trademarks of Integra LifeSciences CSR was found to achieve excellent umbilical, and incisional hernias. Corporation or its subsidiaries in the United States and/or other countries. exposure of the abdominal structures ©2018 Integra LifeSciences Corporation. All rights reserved. 1035834-2-EN comparable to the table-mounted systems (Figure 2). Furthermore, it was noted to have a faster setup time due to its non–table-mounted design.
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GENERAL SURGERY NEWS / AUGUST 2021
For Your Practice: Recent Articles in Hernia Repair n this installment of Journal Watch, we look at recently published articles dealing with a subject near and dear to my heart: hernia repair. As part of the practice of most general surgeons, I hope readers will find these articles on hernia management worthwhile, relevant, and useful to change, question or reinforce current practice. We’ll look at a recent meta-analysis on mesh use in laparoscopic inguinal hernia repair, the effect of immunosuppression and/or corticosteroids on inguinal hernia repair outcomes, and we’ll also take a look at two articles, with differing conclusions, on negative pressure wound therapy after open ventral hernia repair.
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Lightweight Mesh Provides No Benefit Over Heavyweight Mesh in Lap Inguinal Hernia Repair In Annals of Surgery, Bakker and colleagues published further guidance on mesh use for minimally invasive hernia repair (2021;273[5]:890-899). The researchers used both meta-analysis and trial sequential analysis (TSA) of randomized controlled trials that compared outcomes of heavyweight and lightweight mesh. For this study, the authors defined lightweight mesh as less than 50 g/m2 and heavyweight mesh as greater than 70 g/m.2 Included trials compared the different weights of mesh in laparoscopic inguinal hernia repair cases for reducible inguinal hernias using the same surgical technique and fixation method, with at least three-month follow-up. Outcomes measured included postoperative pain and hernia recurrence. TSA was performed to determine whether sufficient data were available within the randomized controlled trials to provide a reliable conclusion. A total of 12 trials were analyzed for 2,909 patients (1,490 with lightweight and 1,419 heavyweight mesh), with follow-up ranging from three to 60 months. Eight studies reported postoperative pain outcomes. Although there was no statistical difference in risk for any pain (123/1,362 patients with lightweight mesh vs. 127/1,277 with heavyweight mesh; relative risk [RR], 0.79; 95% CI, 0.52-1.20) or severe pain (3/1,226 with lightweight vs. 9/1,079 patients with heavyweight mesh; RR, 0.38; 95% CI, 0.11-1.35), TSA showed insufficient data were available to reach a reliable conclusion. Further permutations of analysis were performed based on variables such as recurrence and pain score cutoffs. Eleven studies reported hernia recurrence outcomes. There was a statistically significant increased risk for recurrence with lightweight mesh repairs (32/1,571 vs. 13/1,508 patients with heavyweight mesh; RR, 2.21; 95% CI, 1.14-4.31), which appeared reliable after TSA. Subanalyses continued to show increased risk for recurrence with the lightweight mesh for direct inguinal hernia repair (19/500 patients vs. 6/511 with heavyweight mesh; RR, 2.31; 95% CI, 0.83-6.43), indirect repair (12/866 vs. 6/842, respectively; RR, 1.66; 95% CI, 0.664.18), and laparoscopic repair when fixation was used (10/942 vs. 7/866, respectively; RR, 1.20; 95% CI, 0.403.61). However, TSA revealed insufficient data for these subanalyses. The authors should be lauded for their updated review from the last Cochrane review by Sajid et al in 2013 (Cochrane Database Syst Rev 2013;2:1-50) evaluating outcomes after inguinal hernia repair based on mesh weight. Of note, this study included one of the most recent large randomized controlled trials from Roos et al (Ann Surg 2018;268[2]:241-246). Through TSA, it is evident that high variability within studies still makes it difficult to discern which mesh weight is superior
for postoperative pain. However, there does seem to be strong evidence that lightweight mesh has no advantage, and often poorer outcomes, in regard to hernia recurrence compared with heavyweight mesh. Limitations of this study are those inherent within systematic reviews, but the authors attempt to verify with TSA. Variations in surgical technique and specific mesh types within each randomized controlled trial may make these results difficult to apply to a specific clinical practice. The results, however, are quite strong to demonstrate that lightweight mesh may not provide any superior outcomes to heavyweight mesh, and instead only affect cost of the overall procedure.
Immunosuppression and/or Preoperative Corticosteroids Do Not Increase Wound Complications After Inguinal Hernia Repair In Surgical Endoscopy, Varga and colleagues published their analysis on the effect of immunosuppression and preoperative corticosteroid use on patients undergoing inguinal hernia repair (2021;35[6]:2953-2964).
Using the Herniamed Registry (private practice surgeons from Germany, Austria and Switzerland), the authors identified patients aged 16 years or older who received an initial unilateral inguinal hernia repair with approved surgical techniques and mesh, with one-year follow-up. Matched groups were then delineated by patients with and without immunosuppressive conditions and/or corticosteroid treatments before repair. Matching criteria are further described in the study, but included body mass index, defect size, preoperative pain and operative method. Primary outcomes evaluated included perioperative complications, reoperations within 30 days related to complications, recurrence at one year, pain on exertion,
Arielle Perez, MD, MPH, MS Director of UNC Health Hernia Center and Assistant Professor of Surgery in the Division of General, Acute Care, and Trauma Surgery at the University of North Carolina at Chapel Hill School of Medicine —Column Editor
pain at rest and chronic pain requiring treatment after one year. Secondary outcomes evaluated included rates of bleeding, seroma, surgical site infections (SSIs), bowel injury and ileus. Of note, 142,488 patients met the inclusion criteria for matching, with 2,312 (1.6%) identified with immunosuppressive conditions and/or corticosteroid treatments before surgery. More than half of these patients (1,225) had an open repair; 44% (1,010) had a laparoscopic repair and 2.7% (62) had other techniques. Appropriate patients without immunosuppressive conditions and/or corticosteroid treatments before surgery were identified, and 2,297 propensity-scored pairings were formed for analysis. Propensity score matching analysis of the pairs revealed no effect on primary or secondary outcomes due to immunosuppressive conditions and/or corticosteroid treatments. Subanalysis of patients with only immunosuppressive conditions, only corticosteroid treatments or both revealed no significant difference in outcomes. The authors provide information on the effect of immunosuppressive conditions and/or corticosteroid treatments on postoperative outcomes after initial unilateral inguinal hernia repair. Despite evidence that immunosuppression and corticosteroids can hinder wound healings, the authors’ findings are similar to results from the study by Haskins et al that looked at immunosuppression with ventral hernia repair outcomes, with the notable exception of the difference in seroma rate for inguinal hernia repair (Surgery 2018;164[3]:594-600). Limitations of this study include evaluation of the broad category of inguinal hernia repair rather than specific surgical techniques; generalized evaluation of the immunosuppressed state and corticosteroid use rather than specifics of disease type and/or specific drug and dose; and those limitations inherent in any registry, such as missing and/or incorrect data collection. The authors acknowledge the higher-than-normal postoperative complication rate, but attribute this to the distribution of surgical methods. Nevertheless, their study provides further evidence that hernia repair can be performed safely in most patients with immunosuppressive conditions and/or corticosteroid treatments.
RCT Shows Reduction of SSO and SSI With Negative Pressure Wound Therapy in Open Ventral Hernia Repairs In Annals of Surgery, Beuno-Lledó and colleagues published the results of a single-center randomized controlled trial evaluating the effects of negative pressure wound therapy (NPWT) on closed incisions after ventral incisional hernia repair (VIHR) (2021;273[6]:1081-1086).
AUGUST 2021 / GENERAL SURGERY NEWS
EXTENDED HERNIA COVERAGE 2021
In the study, all adult patients undergoing elective midline VIHR with a defect width of at least 4 cm were eligible. Exclusion criteria included patients with abdominal surgery performed within 30 days, emergency VIHR, cirrhosis and pregnancy. Surgeries were performed by five surgeons; preoperative antibiotics, chlorohexidine prep, mesh use, fascial closure and drain placement were standardized to reduce variability. VIHR consisted of retrorectus repair, transversus abdominis repair or anterior component separation (ACS). Patients were randomized 1:1 to either the intervention group for seven days of NPWT with the PICO system (Smith and Nephew) at –80 mm Hg or normal sterile dressing. The primary outcome was development of a surgical site occurrence (SSO) within 30 days of VIHR. The secondary outcome was hospital length of stay (LOS). The study was powered to see a reduction from 30% to 10% SSOs in the treatment group, requiring a sample size of 150 patients. A total of 150 patients were recruited with 146 analyzed (72 having NPWT and 74 controls). There were no statistically significant differences in baseline or hernia characteristics. Wound class was not provided. There was a statistically significant difference in SSOs (13.6% vs. 29.8%; P=0.042) with an even more impressive
difference in SSIs (0% vs. 8%; P=0.002). All six SSIs were superficial and treated with oral antibiotics, all in the control group: five after ACS and one after retrorectus repair. There was no statistical difference in hospital LOS, seroma, hematoma or dehiscence. Univariate analysis demonstrated a BMI greater than 30 kg/m2 and ACS repair to be predictive of SSIs after surgery. The authors should be commended on undertaking a randomized controlled trial of this magnitude. Their results provide further information on the utility of NPWT after laparotomy, specifically VIHR. Although the study was well protocolized, the spectrum of repair methods with various mesh types makes it difficult to apply the results of the study to all VIHRs. NPWT reduced SSO rates after VIHR, but it is unclear whether it is specific to ACS repair; the study was not powered to draw this conclusion. Postoperative management was not well described, and likely did not include an enhanced recovery after surgery (ERAS) pathway. Of interest, LOS was longer than what has been reported in other studies, such as that from Sartori (Hernia 2021;25[2]:501-521), both with and without ERAS pathways. The authors noted that the absolute cost of NPWT is six times more than standard dressings, but may be offset by LOS, required subsequent procedures and
wound care. However, a cost–benefit analysis was not performed to provide further information on its utility. Only one type of NPWT system was used, such that results may not be applicable to other systems. Drain use may have contributed to no differences seen in seroma and hematoma formation. With prior analysis of the American College of Surgeons National Surgical Quality Improvement Program published by Jolissaint demonstrating that 25% of ventral hernia repair patients will have a recurrence within five years, with the risk doubling for those with an SSO (Surgery 2020;167[4]:765771), results of Bueno-Lledó’s study may provide further support for NPWT use in certain clinical situations. Monitoring of individual surgical practices can provide further guidance on applicability and benefit.
Single-Surgeon Study Shows No Effect of NPWT on Rates of SSO and SSI in Open Ventral Hernia Repair In Hernia, Seaman and colleagues published the results of NPWT on ventral hernia repair from a single center by a single surgeon (2021 May 19. Epub ahead of print). continued on the following page
Table. Summary of Four Studies Discussed Journal Article
Key Takeaways
Words of Caution When Reading
Useful Related Articles
Heavyweight mesh is superior to lightweight mesh in laparo-endoscopic inguinal hernia repair: a meta-analysis and trial sequential analysis of randomized controlled trials. Bakker WJ, Aufenacker TJ, Boschman JS, et al. Ann Surg. 2021;273(5):890-899.
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No difference in postoperative pain with mesh weight after laparoscopic inguinal hernia repair.
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Sajid MS, Leaver C, Sains P, et al. Lightweight versus heavyweight mesh for laparoscopic repair of inguinal hernia. Cochrane Database Syst Rev. 2013;2:1-50.
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Lightweight mesh has no advantage, and often poorer outcomes, compared with heavyweight mesh in regard to hernia recurrence after • laparoscopic inguinal hernia repair.
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Roos M, Bakker WJ, Schouten N, et al. Higher recurrence rate after endoscopic totally extraperitoneal (TEP) inguinal hernia repair with ultrapro lightweight mesh: 5-year results of a randomized controlled trial (TULPtrial). Ann Surg. 2018;268(2):241-246.
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Achelrod D, Stargardt T. Cost-utility analysis comparing heavy-weight and light-weight mesh in laparoscopic surgery for unilateral inguinal hernias. Appl Health Econ Health Policy. 2014;12(4):151-163.
Are immunosuppressive conditions and preoperative corticosteroid treatment risk factors in inguinal hernia repair? Varga M, Köckerling F, Mayer F, et al. Surg Endosc. 2021;35(6):2953-2964.
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Immunosuppressive conditions and/ or corticosteroid treatments had no statistically significant effect on primary or secondary outcomes.
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Subanalysis on patients with only immunosuppressive conditions, only corticosteroid treatments and both revealed no significant differences in outcomes.
Haskins IN, Krpata DM, Prabhu AS, et al. Immunosuppression is not a risk factor for 30-day wound events or additional 30-day morbidity or mortality after open ventral hernia repair: an analysis of the Americas Hernia Society Quality Collaborative. Surgery. 2018;164(3):594-600.
Prophylactic single-use negative pressure dressing in closed surgical wounds after incisional hernia repair: a randomized, controlled trial. Bueno-Lledó J, FrancoBernal A, Garcia-VozMediano MT, et al. Ann Surg. 2021;273(6):1081-1086.
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Jolissaint JS, Dieffenbach BV, Tsai TC, et al. Surgical site occurrences, not body mass index, increase the long-term risk of ventral hernia recurrence. Surgery. 2020;167(4):765-771.
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Sahebally SM, McKevitt K, Stephens I, et al. Negative pressure wound therapy for closed laparotomy incisions in general and colorectal surgery: a systematic review and meta-analysis. JAMA Surg. 2018;153(11):e183467.
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Sartori A, Botteri E, Agresta F, et al. Should enhanced recovery after surgery (ERAS) pathways be preferred over standard practice for patients undergoing abdominal wall reconstruction? A systematic review and meta-analysis. Hernia. 2021;25(2):501-521.
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Chopra K, Gowda AU, Morrow C, et al. The economic impact of closed-incision negative-pressure therapy in high-risk abdominal incisions: a cost-utility analysis. Plast Reconstr Surg. 2016;137(4):1284-1289.
The effect of negative pressure wound therapy on surgical site occurrences in closed incision abdominal wall reconstructions: a retrospective single surgeon and institution study. Seaman AP, Sarac BA, ElHawary H, et al. Hernia. 2021 May 19. doi:10.1007/ s10029-021-02427-3.
Systematic reviews combine information from randomized controlled trials with a wide variation in surgical technique, mesh type and clinical heterogeneity. The authors utilized trial sequential analysis to try to reduce false conclusions. Follow-up ranged from three to 60 months, which may influence capture of specific outcomes.
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Study is generalized and does not evaluate specific immunocompromised states and/or drug doses.
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Study is generalized and does not evaluate specific surgical methods or mesh types.
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Overall complication rate is higher than expected, but thought to be due to distribution in surgical method.
Negative pressure wound therapy (NPWT) is associated with a statistically significant reduction in surgical site occurrence (SSO) and surgical site infection rates.
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Study was powered for incisional hernia repair, but multiple repair methods and mesh types make applicability to a specific surgical practice difficult.
There is no statistically significant difference in hospital length of stay, seroma or hematoma formation and dehiscence with NPWT.
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Specifics of postoperative management were not included, and it is unclear why hospital length of stay is longer than what is expected in the literature.
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Only one type of NPWT system was used and may not be generalizable to other systems.
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Single-surgeon data may not be applicable to other surgeons.
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Perioperative care and surgical methods were not reported in the study.
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Retrospective review of prospectively collected data can be limited by misclassification and abstraction bias as well as loss to follow-up.
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NPWT was not associated with a statistically significant reduction in rates of SSO.
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NPWT was associated with a statistically significant reduction in rate of seroma formation.
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Decreased rates of SSO were associated with skin resection and being immunosuppressed.
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IN THE NEWS
GENERAL SURGERY NEWS / AUGUST 2021
Benefits, Costs of Robotic Diaphragmatic Hernia Repair Weighed By ETHAN COVEY
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recently published study has found that the costs associated with robotic diaphragmatic hernia repair may outweigh any potential clinical benefits compared with laparoscopic surgery. The findings add interesting context to ongoing discussions about the increased role of technology in surgical procedures (J Am Coll Surg 2021;233[1]:9-19.e2). “We set out to study robotic and laparoscopic approaches to diaphragmatic hernia repair [DHR] with the hypothesis that there would be a benefit within the first year postoperatively, related to the improved visualization and dexterity the robot provides,” said lead author Sujay Kulshrestha, MD, a surgeon at Loyola University Medical Center, in Maywood, Ill. The retrospective analysis included information from 2011 to 2018 on patients who underwent transabdominal DHR, and associated inpatient and outpatient encounters within 12 months after the operation. Data were gathered from the Healthcare Cost and Utilization Project State Inpatient and State Ambulatory Surgery and Services Databases for Florida. Of 8,858 identified patients who underwent DHR surgery, 67.3% were treated by laparoscopic DHR, 17.2% by open DHR, and 15.5% by roboticassisted DHR. The overall rate of robotic DHR increased from 5% in 2011 to 26.4% in 2018. Generally, patients who underwent open procedures were older, more likely to be male, had higher comorbidity scores, and were more likely to have Medicare or Medicaid insurance than those who underwent laparoscopic or robotic DHR. The researchers found that of the
three surgical approaches, open procedures were associated with the worst outcomes. Recipients of open DHR had a longer index hospital length of stay and were less likely to be discharged home than those undergoing laparoscopic or robotic DHR.
surgical approaches. “Our results did not identify a tangible clinical or financial benefit that outweighed robotic DHR’s up-front costs,” Dr. Kulshrestha said. “This points to the possible need to expand the follow-up period for research to better understand
‘Our results did not identify a tangible clinical or financial benefit that outweighed robotic DHR’s up-front costs. This points to the possible need to expand the follow-up period for research to better understand global effects of these operations—a lot of the complications we identified were beyond the first 90 days after the index operation.’ —Sujay Kulshrestha, MD However, when compared with laparoscopic surgery, robotic DHR did not fare well. The median length of stay for patients treated by robotic DHR was longer than for those undergoing laparoscopic DHR, and robotic DHR was associated with the highest overall index hospitalization costs. Upon matched analysis, there were no differences in the overall rate of postindex hospital-based encounters between
Journal Watch continued from the previous page
This study was a retrospective analysis of prospectively collected data from 2013 to 2020 in which the surgeon changed his practice from standard dressing of bacitracin ointment, petrolatum-based fine mesh gauze, gauze and tape to uniformly using NPWT after the cost-effectiveness analysis by Chopra et al (Plast Reconstr Surg 2016;137[4]:1284-1289). All ventral hernia repair patients with primary fascial closure and 30-day follow-up were included. A total of 258 patients were included for analysis: 159 (61.63%) undergoing NPWT and 99 (38.27%) having a standard dressing. Mean duration of NPWT was six days. There were higher rates of diabetes, skin resection and skin flaps in patients having NPWT. However, there was no difference in baseline characteristics in patients who did and did not develop SSOs.
global effects of these operations—a lot of the complications we identified were beyond the first 90 days after the index operation.” Shanu N. Kothari, MD, the vice chair of medical staff affairs at the USC School of Medicine in Greenville, S.C., also pointed to the need for longer-term data. “The follow-up was one year, so truly long-term follow-up data remains to be determined.”
There was a total of 65 (25.19%) SSOs; NPWT was not associated with a significant reduction in SSO (27.27% vs. 23.89%; P=0.544). Subanalysis by type of SSO showed NPWT was associated with decreased seroma rates (0.63% vs. 7.07%; P=0.004). Multivariate analysis showed decreased rates of SSO associated with skin resection (odds ratio [OR], 0.295; 95% CI, 0.0960.911; P=0.034) as well as when patients were taking immunosuppressive medications (OR, 0.411; 95% CI, 0.171-0.988; P=0.047), while NPWT had no association in decreased rates of SSO (OR, 0.843; 95% CI, 0.445-1.594; P=0.598). The authors demonstrate the importance of following one’s own data to determine applicability of published results to one’s own practice. Similar to the above study, the impetus for NPWT is to reduce SSOs and SSIs and, in turn, to reduce hernia recurrence. Although this study was published before the above randomized controlled trial (Ann Surg 2021;273[6]:1081-1086), the
Dr. Kulshrestha concurred. “In terms of future directions, similar studies with extended follow-up could help identify late postoperative complications, or provide an understanding of what operations are clinically beneficial and costeffective for prioritizing limited time at a robotic console.” Dr. Kothari also noted that the currently high costs of robotic DHR will likely decrease, potentially making the approach more affordable and leveling existing differences in pricing between institutions. “With a variety of robotic platforms in various iterations of development, I would presume that the charges related to robotic platforms will continue to go down with time,” he said. Most concerning, according to Dr. Kothari, was the higher rate—17.2%— of patients who still underwent open DHR, and the fact that frequently they were the sickest individuals. “These are exactly the risk factors of patients who would benefit the most from a minimally invasive approach, whether it be laparoscopic or robotic,” he said. “The tendency, even in an urgent setting, to do open surgery ‘because it is faster and better for the patient’ is unfounded by studies including this one. These patients spend an extended time in the hospital, are more likely to go to an extended care facility, and in this analysis, the charges were equivalent to the use of a robotic platform.” Dr. Kothari added that the true impact of these various approaches over time is unknown, especially as reoperation rates in the study were very low. “The real question that remains unanswered is the following: What is the financial burden of symptomatic diaphragmatic hernias on health care expenditures and, what, if anything, can we as surgeons do to mini■ mize recurrence rates?” he said.
authors are able to utilize their own data to determine the benefit, if any, of NPWT for their ventral hernia repair patients. Variables that may affect outcomes— such as surgical method, mesh type, hernia width, perioperative care, NPWT system type and presence of drains—can make drawing conclusions unclear. But, with a single surgeon, it can be hypothesized that surgical and perioperative care are somewhat standardized, and the variability within the data set is fairly minimal. Limitations of the study include those inherent in a retrospective review of prospectively collected data, such as misclassification and abstraction bias, and a single surgeon’s practice may not be generalizable to all surgical practices. An interesting finding from this study was that, yet again, immunosuppression does not appear to be associated with increased rates of SSO for hernia repair. Based on the methods of this surgeon’s practice, NPWT is not associated with statistically significant lower rates of SSO. ■
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AUGUST 2021 / GENERAL SURGERY NEWS
Surgery Leads to Fewer Readmissions Than Nonoperative Approach for Inguinal Hernia By BOB KRONEMYER
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lthough readmission after nonelective hospitalization for inguinal hernia is rare, surgical intervention reduced the likelihood of readmission compared with nonoperative management, according to a retrospective review of 2010-2014 data from the Nationwide Readmissions Database. The study, published in Hernia (2021 Jul 3. doi:10.1007/s10029-021-024415) also found that surgical intervention increased hospital length of stay (LOS) and cost of care over nonoperative management. “We were curious to see how helpful the NRD would be in addressing a clinically relevant question,” said principal investigator Hanna Jensen, MD, PhD, an assistant professor of surgery at the University of Arkansas for Medical Sciences (UAMS), in Little Rock. “We chose to investigate hernia surgery because it is one of the most common surgical procedures performed in the United States.” Of the 14,249 patients ages 18 years and older who were admitted nonelectively for a primary diagnosis of inguinal hernia and met inclusion criteria, 63.1% were operative cases and 36.9% were nonoperative cases. The readmission rate within 90 days of the initial admission was 0.49% for surgical patients and 1.78% for nonsurgical patients (P<0.01). However, the mean LOS was longer for surgical than nonsurgical patients: 3.27 vs. 2.76 days (P<0.01). The mean total cost for readmission was also higher for surgical patients: $9,597 vs. $7,167 (P<0.01). The nonsurgical population was on average older and had more chronic conditions. Of the patients initially managed nonsurgically, 62.6% were treated surgically within 90 days of the initial admission. “The study results were as expected,” said Dr. Jensen, the director of clinical research for trauma and acute care surgery at UAMS. “If the treating facility opted to not operate on the initial admission, the readmission rate was clearly higher, while still very reasonable.” A surgical admission often lasts slightly longer than a nonsurgical one, “so we were not overtly surprised about this outcome,” Dr. Jensen said. “Repairing symptomatic inguinal hernias electively is always the optimal approach and likely is associated with the shortest LOS. A nonelective admission for inguinal hernia implies some complications, which likely extends LOS.”
Because the rate of readmission after nonelective surgery for inguinal hernia was extremely low, Dr. Jensen and her colleagues do not believe there are any major issues that need to be addressed, based on the large national study. “However, our data set does not allow us to examine causality or draw robust conclusions about what factors may have predisposed patients to being readmitted,” she said.
In addition, the higher rate of readmission among nonsurgically treated patients “begs the question of whether an operation might have been indicated already on their initial admission,” Dr. Jensen said. “The NRD does not allow us to explore the reasons why any individual patient underwent surgery or received medical treatment only. Thus, we hope that those pathways are closely
evaluated in institutional or multi-institutional studies in the future. Certainly, the reason to refrain from surgical treatment needs to be clear and well justified.” Co-author Avi Bhavaraju, MD, also an assistant professor of surgery at UAMS, said the biggest downside in managing inguinal hernia patients nonsurgically “is the risk of having to be readmitted continued on page 14
The mission of the Americas Hernia Society is to advance the science and treatment of hernia. The vision of the Americas Hernia Society is to be the worldwide authority on hernia surgery. AHS fulfills its mission and vision by, among other things: • Hosting periodic meetings for open presentation and discussion of scientific material concerning subjects of common interest. • Cooperating in educational endeavors with groups of similar interest throughout the world. • Initiating and cooperating in the publication of a journal and/or newsletter on the subject or hernia/abdominal wall abnormalities. • Undertaking projects of scientific interest to seek information and otherwise serve the mission of the organization. Americas Hernia Society www.americasherniasociety.com (847) 228-3302 | info@americasherniasociety.org
The Americas Hernia society offers a number of benefits to our members. We encourage any surgeon interested in abdominal wall abnormalities to join.
MEMBERSHIP BENEFITS • Discounted meeting registration at AHS/EHSmeetings • Educational Webinars • Online member search for patient referral • Journal Hernia • AHSQC
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OPINION
GENERAL SURGERY NEWS / AUGUST 2021
AHS Presidential Address: It’s Just a Hernia, Until It’s Not continued from page 1
is often uncontrolled in the best scientific studies. Expertise, judgment and proficiency improve outcomes. In inguinal hernia repair, our goal as surgeons is to lower our personal risk for complication to less than 0.5%, but that number can and will never be zero. Whatever can happen in surgery, will happen. Let me give you an example. A 70-ishyear-old, robust gentleman underwent an uncomplicated outpatient laparoscopic total extraperitoneal repair. Five days later, he was admitted with an ileus, nothing else on examination, labs and CT scan. On postoperative day 7, on rounds, feculent output came out the periumbilical port. Laparoscopy identified fecal leakage in the preperitoneal space with a clean intraabdominal cavity. This was washed out; a laparoscopic right colectomy was performed; and mesh was removed. A Shouldice repair was performed to address the open inguinal canal and hernia. After a prolonged hospital course, sepsis, abscess drainages, rehabilitation, three months later, the patient went home—a fairly horrible course for a “simple” inguinal hernia repair. In retrospect, the patient reported that his open appendectomy as a young man was accompanied by a long hospitalization with him almost dying from peritonitis. Review of the operative video demonstrated no break in technique or obvious colon injury. A shear injury during dissection of the lateral peritoneal flap likely led to this delayed colon injury with the colon fused to the prior incision. The data and guidelines clearly support a minimally invasive approach; but if only the patient had an open Lichtenstein repair, he would have not been a victim of anatomy and probability. Even more ironic is that he is my patient at the Lichtenstein Amid Hernia Clinic, where we clearly can perform a pretty good open Lichtenstein. And he is a physican. And a professor. And a colleague. And my friend. While I am still below my aspirational 0.5% complication rate for inguinal hernia repairs, and thankfully I could operatively clean up my own mess, I could have done better. This job is always humbling. All for a “simple” inguinal hernia. As surgeons, we strive for perfection but cannot be perfect, and good hernia surgery demands that we be good general surgeons. In an ever-specializing field, Hernia is, and always will be, central to general surgery and the bread and butter of most general surgeons’ practices. Herniorrhaphy is one of the first operations that we teach our interns, the first cases that we book as an independent young attending, and by volume, the most common
operation that we as general surgeons perform for patients. “It’s just a hernia,” until it’s not. Simple procedures can quickly become complex, and our complicated cases in Hernia become more challenging as we work to provide patients with durable repairs, functionality and better outcomes. The field of Hernia has transformed and expanded to encompass a broader complexity of disease and variety of techniques. With novel techniques,
advances in prosthetics, robotic assistance, advanced reconstructive operations, enhanced recovery pathways and continuous quality improvement initiatives, there is more for surgeons to learn than ever. Abdominal wall reconstruction; component separation techniques; minimally invasive and robotic surgery; diaphragmatic, perineal, lumbar, flank, parastomal hernias; athletic pubalgia; chronic groin and abdominal pain; and management of enteric, infectious and
inflammatory complications of hernia clearly demonstrate that the state of the art is anything but simple. We have made significant strides reducing recurrence rates, decreasing morbidity and mortality, shortening hospital stays, dropping infection rates, and generally improving outcomes. With such rapid progress and change, never has it been more important to optimize patient outcomes though education, standardization of techniques,
For complex hernia repair
INDICATIONS STRATTICE™ Reconstructive Tissue Matrix (RTM), STRATTICE™ RTM Perforated, STRATTICE™ RTM Extra Thick, and STRATTICE™ RTM Laparoscopic are intended for use as soft tissue patches to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. Indications for use of these products include the repair of hernias and/or body wall defects which require the use of reinforcing or bridging material to obtain the desired surgical outcome. STRATTICE™ RTM Laparoscopic is indicated for such uses in open or laparoscopic procedures. These products are supplied sterile and are intended for single patient one-time use only. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS These products should not be used in patients with a known sensitivity to porcine material and/or Polysorbate 20. WARNINGS Do not resterilize. Discard all open and unused portions of these devices. Do not use if the package is opened or damaged. Do not use if seal is broken or compromised. After use, handle and dispose of all unused product and packaging in accordance with accepted medical practice and applicable local, state, and federal laws and regulations. Do not reuse once the surgical mesh has been removed from the packaging and/or is in contact with a patient. This increases risk of patient-topatient contamination and subsequent infection. For STRATTICE™ RTM Extra Thick, do not use if the temperature monitoring device does not display “OK.” PRECAUTIONS Discard these products if mishandling has caused possible damage or contamination, or the products are past their expiration date. Ensure these products are placed in a sterile basin and covered with room temperature sterile saline or room temperature sterile lactated Ringer’s solution for a minimum of 2 minutes prior to implantation in the body. Place these products in maximum possible contact with healthy, well-vascularized tissue to promote cell ingrowth and tissue remodeling. These products should be hydrated and moist when the package is opened. If the surgical mesh is dry, do not use.
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AUGUST 2021 / GENERAL SURGERY NEWS
and research to provide evidence that progress translates to better outcomes and value. The Americas Hernia Society (AHS) is leading this change, carrying out our missions of education, advocacy, research, outreach and stewardship. The AHS WISE (Web Information Social Media and Education) initiative, led by Drs. Vedra Augenstein, Conrad Ballecer, Megan Nelson and Sal Docimo, and our robust Education Committee assembles incredible state-of-the-art lectures accompanied by biweekly moderated sessions on the International Hernia Collaborative Facebook page for our
As surgeons, we strive for perfection but cannot be perfect, and good hernia surgery demands that we be good general surgeons. members and the Hernia community to interact. After a pandemic hiatus, our Hernia Compact Program for residents and fellows, Open to Robotics Labs, and Advanced Surgical Skills Handson Labs have resumed to help surgeons to adopt new techniques and skills in a mentored fashion. The AHS has been tirelessly working to advocate for better, more accurate procedure-specific coding and compensation
for Hernia. Led by AHS governors Drs. Scott Roth and John Fischer, we are well into the years-long process to join the RVS Update Committee, advocating to fairly and appropriately value the complexity, diversity and breadth of the services that hernia surgeons provide. The AHS continues to promote the cutting-edge research essential to move our field forward. In collaboration with our partners at the Abdominal
WITH THE STRATTICE™ RTM is designed to be positively recognized, allowing for regeneration and a repair that holds.1,2,* *Correlation of these results, based on animal studies, to results in humans has not been established.
In a recent retrospective evaluation of biologic meshes, including STRATTICE™,
91.7 7 YEARS %
†
OF PATIENTS WERE RECURRENCE-FREE AT POST-OP3,†
Includes porcine and bovine acellular dermal matrices (ADMs) (n = 157). Bridged repair and human ADM were excluded from the study group.
For more information, contact your Allergan Aesthetics representative or visit hcp.StratticeTissueMatrix.com PRECAUTIONS (continued) Certain considerations should be used when performing surgical procedures using a surgical mesh product. Consider the risk/benefit balance of use in patients with significant co-morbidities; including but not limited to, obesity, smoking, diabetes, immunosuppression, malnourishment, poor tissue oxygenation (such as COPD), and pre- or post-operative radiation. Bioburden-reducing techniques should be utilized in significantly contaminated or infected cases to minimize contamination levels at the surgical site, including, but not limited to, appropriate drainage, debridement, negative pressure therapy, and/or antimicrobial therapy prior and in addition to implantation of the surgical mesh. In large abdominal wall defect cases where midline fascial closure cannot be obtained, with or without separation of components techniques, utilization of the surgical mesh in a bridged fashion is associated with a higher risk of hernia recurrence than when used to reinforce fascial closure. For STRATTICE™ RTM Perforated, if a tissue punch-out piece is visible, remove using aseptic technique before implantation. For STRATTICE™ RTM Laparoscopic, refrain from using excessive force if inserting the mesh through the trocar. STRATTICE™ RTM, STRATTICE™ RTM Perforated, STRATTICE™ RTM Extra Thick, and STRATTICE™ RTM Laparoscopic are available by prescription only. For more information, please see the Instructions for Use (IFU) for all STRATTICE™ RTM products available at www.allergan.com/StratticeIFU or call 1.800.678.1605. To report an adverse reaction, please call Allergan at 1.800.367.5737. For more information, please call Allergan Customer Service at 1.800.367.5737, or visit hcp.StratticeTissueMatrix.com. References: 1. Connor J, McQuillan D, Sandor M, et al. Retention of structural and biochemical integrity in a biological mesh supports tissue remodeling in a primate abdominal wall model. Regen Med. 2009;4(2):185-195. 2. Sun WQ, Xu H, Sandor M, Lombardi J. Process-induced extracellular matrix alterations affect the mechanisms of soft tissue repair and integration. J Tissue Eng. 2013;4:2041731413505305. doi: 10.1177/2041731413505305. 3. Garvey PB, Giordano SA, Baumann DP, Liu J, Butler CE. Long-term outcomes after abdominal wall reconstruction with acellular dermal matrix. J Am Coll Surg. 2017;224(3):341-350. STRATTICE™ and its design are trademarks of LifeCell Corporation Corporation, an AbbVie company company. © 2021 AbbVie. All rights reserved. STM147027 05/21
DON’T MESH AROUND
Core Health Quality Collaborative, the AHS annually awards five Hernia and Abdominal Wall research scholarships at the annual meeting, along with the AHS Women Issues in Hernia Surgery Research Scholarship founded by Dr. Shirin Towfigh. We actively are working to recruit new, diverse, talented voices to participate in and lead the AHS. As the umbrella Hernia Society for the Americas, we enjoy and promote robust engagement with our Latin American and Canadian colleagues and our world Hernia partners. We continue to work for greater opportunity and equality in our field, society and communities for all our members, surgeons and patients alike. We are proud of the steps that have been accomplished at the AHS to keep our society open and inclusive, while understanding there is much more work ahead to live up to our hopes and expectations. The AHS Foundation continues to promote charitable and humanitarian outreach with a stronger, formal relationship with Hernia Repair for the Underserved, the charity started by AHS founders Drs. Chuck Filipi, Arthur Gilbert and Bob Fitzgibbons, and includes many of our AHS past presidents and leadership. Now more than ever, we are reminded of the importance of helping one another and advancing our field by taking care of the underserved and serving our neighbors here and abroad. Without hyperbole, the last year has been perhaps the most disruptive, challenging and transformative in most of our personal lives and professional careers. Despite this adversity, we find the field of Hernia at an exciting time. The next chapter in Hernia and Abdominal Wall Surgery will be exciting. We at the AHS will lead this change and help define our growing field. Hernia is inherently a collaborative, collegial, friendly discipline in which surgeons are happy to share, mentor and raise the bar for all so that we can all do better for our patients. We can never be perfect, but we can work together to continue to try. I invite each of you to join the AHS, actively participate in your society and help us lead this exciting change. After a long COVID-19 winter, on behalf of the AHS, Dr. Jeff Janis our program chair, and the Program Committee, we are excited to invite all of you to meet next month in Austin, Texas, in person, ■ for the 2021 AHS annual meeting. —Dr. Chen is a professor of clinical surgery at the David Geffen School Medicine at UCLA, the director of the Lichtenstein Amid Hernia Clinic, both in Los Angeles, and the president of the Americas Hernia Society.
14
IN THE NEWS
Hernia Mesh Talk continued from page 1
After a thorough exam, Shirin Towfigh, MD, the director of the Beverly Hills Hernia Center, in California, suspected Eller was having a rare but serious reaction to the polypropylene mesh. “This was the first time a doctor had even mentioned the possibility of a severe complication or systemic reaction from the mesh,” Eller recalled. Eller’s experience highlights a few major issues now taking center stage in the hernia surgery space: mounting concerns about the safety of mesh, lingering unknowns about the long-term complications associated with hernia repair, and a growing push to improve surgeon– patient communication about these risks and unknowns. The vast majority of patients do fine with hernia mesh, but about 5% of patients may have a major complication, according to a recent analysis (JAMA 2016;316[15]:1575-1582). At the same time, patients with non-mesh repairs are much more likely to experience a recurrence (18.3% vs. 12%), another factor associated with increased pain. “What many patients don’t realize is only a small fraction of people have a bona fide allergy or serious inflammatory reaction to the mesh,” Dr. Towfigh said. In other words, while mesh may be the downstream cause of a complication when, for instance, the material migrates, surgeons still need more data to tease out the extent to which other factors—surgeon technique, reinforcement approach, mesh placement and scar tissue—contribute to or cause the problem. Despite this complexity, hernia mesh has become the poster child for postoperative issues. In a 2020 study analyzing growing chatter about hernia mesh on Twitter and Facebook between December 2016 and August 2019, Dr. Towfigh and her colleagues found 95% of tens of thousands of Facebook comments discussed hernia mesh in a negative light, and more than one-third of 1.1 million tweets about hernia mesh were negative (Am Surg 2020;86[10]:1351-1357). Several top commenters had affiliations with
GENERAL SURGERY NEWS / AUGUST 2021
law firms that, over the past five years, have invested tens of millions of dollars advertising hernia mesh complications and pushing class action lawsuits. “If you have a hernia mesh, a TV and pain, it’s easy to blame the mesh,” said Michael J. Rosen, MD, the director of the Cleveland Clinic Center for Abdominal Core Health. “Concerns about mesh have dramatically changed the conversation between hernia surgeons and patients. I now get questions about mesh from every patient I operate
on, and it’s important to be honest with patients that, although serious mesh complications are rare, there are still a lot of unanswered questions about longterm outcomes.”
Challenges Identifying a Mesh Complication In 2017, Eller underwent allergy testing to determine whether she, in fact, was reacting to her mesh. The test involved placing a few small pieces of mesh on her back and waiting to see whether she’d respond. “I had a severe reaction to the
Readmissions continued from page 11
to the hospital for the same problem and the moderate chance of requiring surgical intervention if readmitted. The inconvenience and quality-of-life issues associated with readmission to the hospital should also be taken into account.” Dr. Bhavaraju noted the results of the study should be looked at in context, partly due to the design’s retrospective and database nature. “While the percentage of readmitted patients who were initially managed nonoperatively is low, readmission is still more than
polypropylene material and a more minor reaction to a hybrid mesh with some polypropylene,” she said. Although the results helped confirm Dr. Towfigh’s hunch, allergy testing often provides limited to no clarity. In another recent analysis, Dr. Towfigh reported mesh allergy testing had a falsenegative rate of 40% or more. “In most instances, we have noo definitive way to determine if mesh is to blame for a patient’s pain,” she said. If there’s no
visible allergic reaction to the material, “often the best evidence is whether a patient’s symptoms resolve after mesh removal. But removing mesh is also not a cureall. In 2018, Dr. Towfigh shared her center’s experience removing 105 mesh from 97 patients over 4.5 years (Hernia 2018;22:953-959). According to the analysis, the major reasons for mesh removal included infection, meshoma and pain. The authors also cautioned that mesh extraction can be technically complex and comes with its own issues, including
three and a half times more likely if the hernia was initially managed without surgery compared to those who were initially fixed,” he said. “We can therefore reasonably conclude that patients with symptomatic inguinal hernias would probably benefit from having their hernias repaired during the index admission because those managed nonoperatively have a higher chance of short-interval readmission for the same problem and will ultimately require operative fixation of the hernia.” Although the total cost of care was higher in the operative group, “they have a lower chance for readmission and the associated risks, complications and lifestyle
a neurectomy and a high risk for recurrence. What’s worse, a patient’s pain may not improve after removing the mesh. “It can feel like we’re chasing our tails when operating for pain,” said Alfredo Carbonell, DO, FACS, FACOS, the codirector of the Hernia Center of Prisma Health and the University of South Carolina School of Medicine, in C Columbia. But predicting which patients might have a lifealtering reaction to mesh before surgery is also nearly impossible. Ineffective post-market survveillance along with poor patient follow-up are, in large part, to blame for this knowledge gap. “If you’re going to implant something that is expected to last a lifetime, surgeons, industry, hospitals, insurers and the FDA need to be following those patients and implants on a long-term basis to make sure everything is safe,” said Benjamin Poulose, MD, MPH, a general surgeon at The Ohio State University (OSU) Wexner Medical Center, in Columbus, and the co-director of OSU’s Center for Abdominal Core Health. “Given challenges with patient follow-up and postmarket surveillance, we still have limited data to guide decisions about the best individualized option for patients.”
Creating a Patient–Surgeon Team After an umbilical hernia repair in August 2014, Eric Beauford began feeling an intense burning sensation across his midsection. “My abdomen was so tender, even a shirt touching my skin hurt,” Beauford said. Beauford, at the time an active man in his early 40s, returned to his general surgeon to explain his symptoms, and got the brush-off. The surgeon told him his pain should resolve in several weeks and to continue wearing an abdominal wrap. The pain only got worse. After some research, Beauford began to wonder whether his symptoms could be related to the implanted porcine biologic mesh—a possibility not discussed before surgery.
adjustments that come along with a second hospital stay,” Dr. Bhavaraju said. Dr. Bhavaraju said it would be interesting to investigate which patient factors in the nonoperatively managed group might predict failure of this approach and eventual readmission and crossover to surgical management. “If we can elucidate these predictive factors, then perhaps we can more effectively triage those higher-risk patients into an initial operative management strategy at the index admission.” Dr. Jensen added,: “Obviously, the universal goal is to ensure that all patients receive prompt and appropriate care with minimal risk of readmissions down the road.” ■
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But his surgeon dismissed the question. And when Beauford’s insurance coverage for surgical follow-up had ended, “my surgeon put his hand on my shoulder and walked me out the door,” he recalled. Some patients, like Beauford, feel their concerns are disregarded when a complication arises. But many hernia experts are listening. The Abdominal Core Health Quality Collaborative (ACHQC) has spearheaded efforts to bring industry leaders and patients together and collect long-term data on patient outcomes. Eller and Beauford were asked to join the ACHQC Patient Advocacy Committee. “A unique part of the QC’s agenda is to help enhance the doctor–patient relationship and make patients informed partners in their care,” said Paul Szotek, MD, FACS, the director and CEO of Indiana Hernia Center, in Indianapolis. To foster that partnership, experts first need to understand patients’ expectations before surgery and experiences after surgery. At a June ACHQC webinar titled “Enhancing Outcomes: The Patient Perspective,” Bryan Ellis, DO, presented his research on patient- and surgeon-reported recurrences after ventral and inguinal hernia repairs, and found that their perceptions did not necessarily align. Of 36,157 mostly mesh-reinforced ventral hernia repairs, 20% of patients reported a bulge or recurrence at one year compared with 11.5% of surgeons. With inguinal hernia repairs, patient and surgeon perceptions aligned more closely: Almost 7% of patients reported a recurrence compared with 9% of surgeons. But a 2016 study reported a much wider gap. The analysis found that patient-perceived adverse events were about five times higher than those recorded in the Swedish Hernia Register (Int J Surg 2016;35:100-103). “What I consider a successful repair may not be what a patient considers successful,” Dr. Carbonell said. “That’s why I always ask my patients what they want to get from a hernia repair and give them a realistic sense of what they might expect. The reality is, as physicians, we are part of a team with the patient and need to be sensitive to their concerns and let them know we’re with them for the long haul if they do have a complication.” Experts also stressed the importance of providing extensive education before surgery. That includes spending time with patients to listen and address their questions about hernia mesh, being honest with them about the knowns and unknowns, and embracing a shared decision-making approach to their care. Dr. Szotek, for instance, walks patients through different techniques, mesh or no-mesh options, and the benefits and
risks of each. He also uses a texting app that includes educational videos and offers a direct line of communication with him, in case patients have questions throughout the process. “Communication before and after surgery is everything,” Dr. Szotek said. “The idea is to give patients a choice and make the doctor–patient relationship front and center.” Given a growing patient demand for non-mesh options, Dr. Poulose reintroduced Shouldice repairs into his practice for patients with inguinal hernias. “Even with a higher chance of recurrence, some
patients are willing to make that trade-off and avoid mesh,” he said. “And it’s important to give patients who are eligible for a non-mesh repair a choice.” Beauford and Eller hope their stories will give hernia surgeons a window into the patient experience and help future patients navigate their care. “I’m not giving up, and I hope my situation can help improve communication so that patients’ concerns and symptoms are heard and acknowledged,” Eller said. Drs. Rosen and Poulose see this moment as an opportunity to change the culture of the disease.
“Hernias are much more complicated than we thought,” said Dr. Rosen, the medical director of the ACHQC. “Surgeons need to take mesh and other postoperative complaints seriously, and we need long-term outcomes to make the best decisions for our patients.” Ultimately, Dr. Poulose said, “the current medical-legal climate is bringing up a necessary conversation in a convoluted way, but if these discussions help us make mesh, technique, postmarket surveillance and patient selection more optimal, something positive ■ can result.”
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» Learn more at goremedical.com/synecor. W. L. Gore & Associates, Inc. | Flagstaff, AZ 86004 | goremedical.com 1. Crawford N. Assessment of Vascularity via Micro CT in Various Patch Devices. Flagstaff, AZ: W. L. Gore & Associates, Inc.; 2016. [Final study report]. 2344TL. 2. Berman A. Evaluation of Plexus with film and ETHICON PHYSIOMESH® in a 30-day rabbit intraperitoneal model. Flagstaff, AZ: W. L. Gore & Associates, Inc.; 2015. [Study protocol]. 2335SC. 3. Berman A. Evaluation of Plexus with no film and ETHICON PHYSIOMESH® in a 30-day rabbit subcutaneous model. Flagstaff, AZ: W. L. Gore & Associates, Inc.; 2015. [Study protocol]. 2336SC. Consult Instructions for Use eifu.goremedical.com
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