The National Pancreas Foundation Centers Of Excellence

from November 2021 Print Issue

Welcome to the November issue of The Surgeons’ Lounge. We dedicate this issue to the National Pancreas Foundation (NPF) Centers of Excellence program that uses a multidisciplinary team approach to achieve better outcomes for patients with pancreatic cancer.

Mayank Roy, MD, a hepatobiliary surgeon, and Arun Nagarajan, MD, a medical oncologist, both at Cleveland Clinic Florida, in Weston, provide up-todate answers to the most common questions regarding the NPF Centers of Excellence for pancreatic cancer.

Also in this issue, you will find another installment of “The Instrument, the Name,” featuring the Thompson Retractor.

We look forward to our readers’ questions, comments and interesting cases to present.

Sincerely, Samuel Szomstein, MD, FACS Editor, The Surgeons’ Lounge Szomsts@ccf.org ACS

Pancreatic centers of excellence can act as a guide for these patients, where they can get high-quality care for pancreatic cancer without traveling long distances.

Better Outcomes in Pancreatic Cancer

The National Pancreas Foundation Centers of Excellence Program

Dr. Lisandro Montorfano, a PGY-4 surgical resident at Cleveland Clinic Florida, Weston, interviews hepatobiliary surgeon Dr. Mayank Roy, and medical oncologist Dr. Arun Nagarajan.

Dr. Montorfano: What are some new advances in pancreatic cancer treatment?

Drs. Roy and Nagarajan: More than 60,000 people will be diagnosed with pancreatic cancer, and more than 48,000 people will die from the disease in the United States in 2021. Traditionally, surgical resection has been the cornerstone of treatment for resectable pancreatic cancer. However, the prognosis remains poor. The addition of chemotherapy, and in some cases, radiation, improves survival. Recent trials have looked at the sequence of treatment to compare adjuvant and neoadjuvant therapy. In addition, in the last decade, genetic analysis and immune therapy have been the topics of interest for researchers and clinicians. While immune therapy on its own has not shown improved survival in pancreatic cancer because of a very resistant tumor microenvironment, it has shown some promising results in combination treatment.

What is the National Pancreas Foundation (NPF) Centers of Excellence program for pancreatic cancer?

Drs. Roy and Nagarajan: The NPF Centers of Excellence program is a charitable organization set up in 1997, to provide resources to patients and their families affected by pancreatic disease. The Centers of Excellence program provides research funds, advocates for new therapies, and provides education for patients and physicians, and is one of the pillars of the NPF. Centers of excellence are premier health facilities located throughout the United States. These centers can provide pancreatic cancer patients with specialists to help with the diagnosis and treatment, including surgery. In addition, they can help patients with overall management, including pain, nutrition and psychosocial support.

How is the program structured? What specialties does it involve? How do hospitals become members of this prestigious program?

Drs. Roy and Nagarajan: Centers of Excellence for pancreatic cancer are selected based on the criteria developed by experts in the field, with a high-level focus on multidisciplinary treatment of pancreatic cancer. This involves active participation of pancreatic surgeons, gastroenterologists, medical oncologists, endocrinologists, radiation oncologists, pathologists, radiologists and genetics specialists through a biweekly multidisciplinary gastroenterology tumor board. The program should be able to support next-generation sequencing and molecular and genomic profiling. In addition, nutritional support, palliative care and psychosocial support should be available. Hospitals can apply if they meet all these criteria through a yearly application.

What is the benefit of implementing the NPF Centers of Excellence program for pancreatic cancer?

Drs. Roy and Nagarajan: Most European models have moved toward centralizing pancreatic cancer care around state-of-the art referral centers where a multidisciplinary approach is used to manage the patients. Although we are slowly adopting these changes in the United States model,

wide geographic distances create a challenge. From a patient’s perspective, they often do not want to travel long distances for their treatment. Pancreatic Centers of Excellence can act as a guide for these patients, where they can get high-quality care for pancreatic cancer without traveling long distances.

What is the reaction of your patients when you explain to them what the NPF program Dr. Mayank Roy entails?

Drs. Roy and Nagarajan: From a patient’s perspective, they may not understand the concept of Centers of Excellence. Although we cannot provide solid evidence of better outcomes solely based on the programs themselves, the fact that the fundamentals of these programs are based on Dr. Mayank Roy high volume, expertise and a multidisciplinary approach allows patients to feel satisfied with and confident in their treatment.

Are pancreatic cancer outcomes improving nationwide since the program has been implemented?

Drs. Roy and Nagarajan: Outcomes in the form of complications and survival for pancreatic cancer have been shown to be better in high-volume centers. Some of the criteria for Centers of Excellence for pancreatic cancer involve volume and expertise (e.g., a minimum of >100 ERCPs, >100 endoscopic ultrasound procedures and >12 pancreticodudoenectomies a year, and a gastroenterologist and surgeon with >5 years of experience). Although the Centers of Excellence concept is still a relatively new concept with minimal data, the fundamentals on which it is based will translate into better outcomes.

Are similar Centers of Excellence program guidelines being implemented in the rest of the world?

Drs. Roy and Nagarajan: The NPF gives accreditation to centers located in the United States. As mentioned earlier, most European models have already shifted toward centralization of care for pancreatic cancer.

Are the standards of the NPF program reproducible in rural and community hospitals?

Drs. Roy and Nagarajan: Presumably, if rural and community hospitals can meet all of the requirements and criteria deemed essential by NPF experts, then they can provide the same high standard of quality care to pancreatic cancer patients, similar to other Centers of Excellence. ■

THE INSTRUMENT, THE NAME: THE THOMPSON RETRACTOR

By Lisandro Montorfano, MD A “retractor” is defined as a device used by surgeons to separate the ends of a surgical incision. Although retractors are very popular and have been used for centuries, not many surgeons know the origins of the different retractors they use.

The developer of the Thompson Retractor (Figure), Richard C. Thompson, MD, studied medicine at the Stanford Medical School, in California, and practiced anesthesia for more than 30 years. It was during this time that he developed the first table-mounted retractor.

It all started in 1959, while Dr. Thompson was observing tonsillectomies. He noticed the McIvor mouth gag depressed the children’s chest wall with every inspiration as the weight of the retractor rested on their chest. During one of these tonsillectomies, Dr. Thompson observed a colleague secure the McIvor mouth gag to a towel with a Kelly clamp to free his hands and perform other tasks in the OR. Dr. Thompson also witnessed a nurse adjusting stirrups and recognized that the universal joint on the operating table allowed them to be adjusted in nearly any position. He decided to integrate these two ideas, and designed a McIvor mouth gag that could be secured by a steel rod to the operating table using a universal joint.

Colleagues in vascular surgery showed interest in this new system and requested Dr. Thompson to develop a new table-mounted retractor system that could replace handheld retractors. The first table-mounted retractor system was born. Dr. Thompson patented his retractor in 1965, but the first prototype did not function efficiently due to mechanical problems. To address this, he contacted the chief metallurgical engineer of the Lockheed Aircraft Corporation, who was an old acquaintance. The engineer suggested Dr. Thompson use a particular type of stainless steel and a particular heat treatment, both of which were used in aircraft landing gear. After heeding the engineer’s advice, the table-mounted retractor became efficient and ultimately successful. While observing various surgical procedures, Dr. Thompson came up with different versions of his retractor system.

In the 1980s, Dr. Thompson was approached by Dan Farley, an industrial designer and the son of the neurosurgeon Dr. Albert W. Farley Jr., with a new table-mounted, self-retaining retractor prototype for neurosurgery. Dr. Thompson was very impressed with both the new prototype and Mr. Farley, and suggested that he take over his company and use it as a stepping-stone to further develop and market his retractor systems.

The Thompson retractor has become increasingly popular and is still one of the most frequently used table-mounted, self-retaining retractors in the United States. These retractor systems have continued to lead the way in providing the visibility that surgeons need and has become synonymous with open surgery.

Nanopore Sequencing

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general surgery resident at Mayo Clinic in Rochester, Minn.

Researchers collected bile duct fluid from 41 patients undergoing pancreatic head resection and sent it for both standard culture and nanopore sequencing for microbial profiling. The results were presented at the 2021 joint annual meeting of the Central Surgical Association/Midwest Surgical Association (abstract 22).

“The nanopore sequencing involves extraction of the total DNA from a sample and then you deplete the host DNA and amplify the microbial DNA,” Dr. Yonkus explained. “You then take that microbial DNA and you sequence it on a nanopore sequencer. Then you take all those genes and you compare it back to a genomic library, which allows you to identify a wide variety of pathogenic bacterial organisms and their anticipated antibiotic sensitivity or resistance.”

De-identified results of both tests were provided to a surgical clinical pharmacist and an infectious disease physician for antibiotic recommendations. Time to results was defined as time from sample acquisition to either final standard culture or nanopore sequencing results.

Roughly half (52%) of the samples from patients came back as positive in standard cultures, and all patients (100%) had organisms detected using nanopore sequencing. On average, nanopore sequencing detected twice as many bacterial species compared with standard culture (10.5 vs. 4.4; P<0.05). Resistance genes were screened using nanopore sequencing in the 22 positive samples, with a mean of 6.4 genes being detected. The predicted resistance phenotypes were significantly greater from nanopore sequencing than using standard cultures (10.3 vs. 2.7; P<0.05). Antimicrobial recommendations for nanopore sequencing provided coverage for standard culture results in 61% of samples. Using the nanopore sequencing technology was significantly faster than standard cultures (median time to results, eight vs. 165 hours) but came at a higher cost ($165 vs. $38.49). “That really is a nominal increase if you consider the cost of one surgical site infection is up to $30,000 or can, even worse, cost a patient their life,” Dr. Yonkus said.

Nanopore sequencing also provided a perfect negative predictive value. “In all patients who had no growth on standard cultures, they also had no growth detected using nanopore sequencing,” she said. “So, all of those patients, about half, could have discontinued their prolonged course of antibiotic prophylaxis on postoperative day 1. That makes up for the additional cost of the assay, the extra days of unnecessary antibiotics, and it also prevents the known complications associated with prolonged antibiotic administration.”

The researchers say because microbiome metagenomics may prove to be applicable to all body fluid samples (blood, urine, etc.), nanopore sequencing may have a major impact on diagnosis and treatment of all surgical site infections. Dr. Yonkus and her colleagues are in the process of planning a randomized controlled trial of

the nanopore sequencing for patients undergoing pancreatic head resection.

Asked to comment on the study, Nicholas Zyromski, MD, a professor of surgery at Indiana University School of Medicine, in Indianapolis, said it’s significant. “Bacteria in the biliary system is very important in pancreatic and biliary surgery. What we know is that when the bile duct undergoes instrumentation, which it almost always does for patients who have cancers in the head of the pancreas or cancers that are blocking the bile duct, the bile that needs to be instrumented is contaminated with bacteria typically from the intestinal system. What that leads to when we operate is an increased incidence of infection.

“So, the ability to diagnose the type of bacteria quickly would be a major advantage. When we suspect an infection, we typically prescribe a broadspectrum antibiotic, and when the bacteria is isolated, we can narrow the spectrum of antibiotics. This technology allows the narrowing of the bacteria coverage quite a bit earlier and potentially cuts down the development of resistant bacteria.”

Dr. Zyromski said the study was potentially practice-shifting methodology to diagnose infections, but the technology was not yet widely available. “The study was done in the bile ducts, but this could be potentially used in a number of other body systems,” he added. ■

Nanopore sequencer.

Image courtesy of BioRender.com.

Hernia Mesh and Litigation: Where Things Stand

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five years, so much so that many of them are being tried as multi-district litigation (MDL).

“MDL is a creature of the federal court system; typically, you’ll bring a number of cases that have been filed in a variety of districts around the country under one umbrella,” said Todd R. Bartos, Esq., an attorney with The Bartos Group LLC, in Lancaster, Pa.

“The MDL is basically an efficient way to consolidate common portions of cases and reduce the risk of inconsistent results. MDLs also encourage the quick resolution of these cases by trying one case, the bellwether case,” Mr. Bartos said. “Generally, as goes the bellwether case, so goes the entire group of cases.”

What Are All These Lawsuits About?

The complaints against inguinal and incisional hernia repair with mesh have some similarities, but not entirely; legal issues in inguinal hernia repair revolve mainly around chronic groin pain.

In 2013, a commentary by Josef Fischer in “Fischer’s Mastery of Surgery” argued that mesh is responsible for inguinodynia and that surgeons should stop using it; this provoked a counterargument by Arthur Gilbert that autologous repair, along with its higher recurrence rate, also causes chronic groin pain, Dr. Voeller said.

“Dr. Gilbert’s position was that the pain is due to the absence of technique, not the technique itself.”

Thus, paper after paper examined recurrence rates and pain with or without mesh; in sum, the clinical data find mesh-based laparoscopic inguinal repairs less associated with chronic groin pain than any other type of repair, Dr. Voeller said. “Mesh in and of itself is not a major cause of chronic groin pain.”

This is not to imply that mesh is benign; take the case of mesh in transvaginal pelvic organ prolapse (TV-POP), which was FDA approved for this indication in 2001 as a 510(k) clearance.

“But we had no short- or long-term safety data regarding this use due to the 510(k) approval process not requiring clinical trials; as more surgeons started using mesh, we saw more complications at a rate up to 50% for erosion, pain, infection, dyspareunia and GU [genitourinary] issues,” Dr. Voeller said.

Ultimately, the FDA required all companies to withdraw mesh for TV-POP in 2018. Soon, lawsuits around mesh use in that procedure were big news and big money.

“In 2019, TheNew York Times reported that seven manufacturers paid nearly $8 billion to resolve more than 100,000 claims. The law firms got a lot of money; having profited from these claims, they decided to look at mesh in inguinal and incisional hernia,” Dr. Voeller said.

Complaints against mesh use in incisional repair are similar to those in TVPOP: pain, erosion, recurrence, bowel obstruction, seroma, infection and death—“all the complications we see with complex reconstruction of the abdominal wall,” Dr. Voeller said.

“In these lawsuits, the material is accused of tearing or breaking, the coatings don’t prevent adhesions, the pore size isn’t right—the complaints go on and on.”

Plaintiffs’ counsels are not just motivated by money, Mr. Bartos said. “Many are truly in it to protect patients and prevent avoidable harm. Where we get into disputes is whether something is ‘avoidable’ or simply a known risk of using a foreign material to repair a fascial defect. Many times, there are issues of what a manufacturer knew and when it knew it regarding risk profiles. But there is no arguing that it is a lucrative business, and there are some who invest heavily in ads to generate a larger group of plaintiffs.”

Although many cases were suspended in 2020 due to the coronavirus pandemic, these cases are now working their way through the multi-district litigation system.

Tips for Surgeons Using Mesh

Have detailed, documented conversations with patients.

“Explain why mesh is necessary, the pros and cons of different types of mesh, and whether there’s an alternative,” said Todd R. Bartos, Esq., an attorney with The Bartos Group LLC, in Lancaster, Pa. “Also, explain post-op instructions. Tell them why it’s important not to lift that 40-pound bag of dog food for the next six weeks.”

Take clear operative notes.

“The op note is the critical piece to keep surgeons out of the hot seat. It’s one thing for mesh manufacturers to bear the risk of litigation of a failed product, but you want to make sure that you’re minimizing your chances that a failed product will be argued to have also been improperly applied,” Mr. Bartos said.

Maximize patients’ preoperative condition and manage expectations.

“We have to let patients know that abdominal wall reconstruction is a very complex surgery w with complex issues and the potential for w significant complications,” said Guy Voeller, MD, a professor of surgery at the University of Tennessee Health Science Center, in Memphis, at the 2021 virtual Abdominal Wall Reconstruction Conference.

Where We Stand Now

At this point, many of the manufacturers of mesh used in hernia repair are involved in MDLs. Although many cases were suspended in 2020 due to the coronavirus pandemic, these cases are now working their way through the MDL system; the case against Bard and its Ventralight ST mesh rebooted in August 2021.

“The use of MDL and bellwether cases gives a sense of where a jury would go in each of the other tens of thousands of potential cases. That allows a reasoned risk calculation for both sides,” Mr. Bartos said.

If there is a loss at trial, that is not the end of it. “If Bard loses and there is a damages award, typically the MDL parties would get together to discuss a global settlement, but Bard could appeal a bellwether case defeat,” Mr. Bartos said. ■

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