General Surgery News: June 2021

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GENERAL SURGERY NEWS The Independent Monthly Newspaper for the General Surgeon

GeneralSurgeryNews.com

June 2021 • Volume 48 • Number 6

Eliminating 24-Hour Call: Does It Work?

Experts Debate Short-Course Radiation for Rectal Cancer

One Institution’s Efforts to Restructure ns Call for Acute Care Surgeons

By KATE O’ROURKE

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s short-course radiation for rectal cancer finally ready for prime time? This was the topic of a lively debate at the Society of Surgical Oncology’s 2021 International Conference on Surgical Cancer Care.

By VICTORIA STERN

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n September 2017, Robyn Richmond, nd, MD, stepped into a bustling Levell I trauma center in Texas.

The acute care surgeon was ready dy to tackle a typical day treating what-ever emergency came through the door: a patient with severe burns, a gunshot wound, an appendix close to rupturing.

Pro: Short-Course Is Ready For Prime Time Cornelius Van de Velde, MD, PhD, a professor of surgery at Leiden University Medical Center, in the Netherlands, argued for the pro side. “I coordinated four phase

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TIMELY TOPICS IN SURGERY

THE GREAT DEBATES

OPINION

On Learning to Land

A Response to ‘Guidelines for Avoiding Bile Duct Injury: Beware’

Ants to Robotics: 10 Tools of Surgery

By ALLAN BYRON PEETZ, MD, MPH

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here is a special moral weight to the role of the surgeon as teacher. I suspect that almost every surgeon, especialp lly those of us who work with residents, feels this way. I’ve also always thought the surgeon–trainee relationship presents interesting ethical questions and was reminded of this recently when I started flying again.

The experience of an instructor teaching me how to fly has shed new light on surgical education for me. I know many of you have grown tired of the analogies that have been made between aviation and surgery.

At the risk of banality, I offer one more aviation and surgery analogy, but through an ethicist’s lens.

e wish to respond to The Great Debate between Drs. Guy Voeller and Leo Gordon (April 2021) in follow-up to the prior debate on the role of intraoperative cholangiography (IOC)/ imaging during laparoscopic cholecystectomy (December 2020).

In the most recent debate, Dr. Voeller raises a number of points, in particular about the consensus conference’s clinical practice guidelines on the

rom the earliest times, prehistoric humans have incurred wounds from violence or accident, and the human instinct has been to close them.

But how? Around 10,000 b.c., cultures in South America, Africa and Asia employed the heads of ants to close skin wounds.

Several species were used, primarily Dorylus (army ants) and Paraponera (bullet ants). The living ant is grasped behind the head, forcing it to widely open its jaw; mandible and maxilla are carefully placed on

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W

F IR ST LOOK

6 The American Society of Breast Surgeons IN THE NEWS

9 How Acute Care Surgery Team T H E SURGEONS’ LO U N G E

14 Management of Esophageal Cancer

Tri-Staple™ 2.0 Reinforced Reloads: Preloaded Buttressing for Bariatric Procedures PAGE 10

facebook.com/generalsurgerynews

Ants, Thorns and Fibers A

F

By MICHAEL BRUNT, MD, et al

Continued on page 12

Managed the COVID-19 Surge

By HENRY BUCHWALD, MD, PhD B

@gensurgnews

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IN THE NEWS

JUNE 2021 / GENERAL SURGERY NEWS

Experts Debate Short-Course Radiation for Rectal Cancer continued from page 1

3 studies utilizing short-course radiation short-course radiotherapy (n=135) in therapy for rectal cancer, and I conclude patients with T3 or T4 resectable primaon these and many other studies that it is ry tumors and no evidence of sphincter ready for prime time. Short-course radia- involvement on digital rectal examination therapy has proven to be very effective.”

‘With the possibility of delayed surgery as He said the first proof that short-course radia- a valid option in the treatment, a window tion works for rectal canof opportunity opens bringing forward cer comes from five years of follow-up from the chemotherapy after radiation therapy Swedish Rectal Cancer before surgery, treating micrometastases Trial of patients younger than 80 years of age in these advanced rectal cancer patients.’ who had resectable rec—Cornelius Van de Velde, MD, PhD tal cancer (N Engl J Med 1997;336[14]:980987). This trial compared surgery alone tion (Br J Surg 2006;93[10]:1215-1221). (n=557) with surgery and preopera- The lower tumor margin had to be accestive short-course radiation therapy with sible by digital rectal examination. Patients 25 Gy delivered in five fractions in one receiving long-course chemoradiotherapy week (n=553). At five years, the research- received 50.4 Gy in 28 fractions of 1.8 ers identified a gain of 10% in overall Gy, plus bolus 5-fluorouracil and leucovsurvival (58% vs. 48%; P=0.004) with orin with surgery after four to six weeks. short-course radiation therapy. Short- Patients receiving short-course radiothercourse radiotherapy also reduced the apy received 25 Gy in five fractions of 5 local recurrence rate from 27% to 11% Gy and surgery within seven days. At four (P<0.001) and increased cancer-specific years, there was no significant difference survival from 65% to 74% (P=0.002). in overall survival, disease-free survival or The Polish I study compared long- local recurrence between groups. course chemoradiotherapy (n=157) with “The results indicated that radiation

Senior Medical Adviser Frederick L. Greene, MD Charlotte, NC

toxicity was significantly more after long-course radiation therapy, but all the other results were the same,” Dr. Van de Velde said. Although severe late toxicities did not differ significantly, early radiation toxicity was greater with longcourse radiation (18% vs. 3%; P<0.001).

The Tasman Radiation Oncology Group trial 01.04 compared long-course chemoradiotherapy (50.4 Gy, 1.8 Gy per fraction in 5.5 weeks plus fluorouracil 225 mg/m2 per day; surgery in four to six weeks; four courses of adjuvant chemotherapy; n=163) with shortcourse radiotherapy (5×5 Gy in one week, early surgery, six courses of adjuvant chemotherapy; n=163) (J Clin Oncol 2012;30[31]:3827-3833). Patients had stage 3N0 to 2M0 rectal adenocarcinoma with 12 cm from the anal verge. The study indicated no significant differences between the two groups in terms of control of the tumor or toxicity.

The Stockholm III trial compared short-course radiotherapy with

MISSION STATEMENT OF GSN It is the mission of General Surgery News to be an independent and reliable source of news and analysis about the current state of surgery. It strives to provide a venue for discussion and opinions, from all viewpoints, on the issues most important to surgeons.

Peter K. Kim, MD Bronx, NY

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Lauren A. Kosinski, MD Chestertown, MD

Gina Adrales, MD, MPH Baltimore, MD

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Maurice Arregui, MD Indianapolis, IN

Raymond J. Lanzafame, MD, MBA Rochester, NY

Philip S. Barie, MD, MBA New York, NY

Timothy Lepore, MD Nantucket, MA

L.D. Britt, MD, MPH Norfolk, VA

Robert Lim, MD Tulsa, OK

James Forrest Calland, MD Charlottesville, VA

John Maa, MD San Francisco, CA

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long-course radiotherapy and immediate versus delayed surgery. In the study, 840 patients with stage I to III rectal cancer were randomized to receive 5×5 Gy followed by direct surgery (less than one week), 5×5 Gy followed by delayed surgery (four to eight weeks), or 25×2 Gy followed by delayed surgery (four to eight weeks) (Lancet Oncol 2017;18[3]:336346). The study concluded there were no significant differences among the three regimens in local or distant recurrence, recurrence-free survival, overall survival or surgical complications. There was a trend toward fewer postoperative complications with short-course and delayed surgery.

“With the possibility of delayed surgery as a valid option in the treatment, a window of opportunity opens bringing forward chemotherapy after radiation therapy before surgery, treating micrometastases in these advanced rectal cancer patients,” Dr. Van de Velde said.

The RAPIDO trial included 920 patients with locally advanced rectal cancer randomized to standard chemoradiation therapy and then surgery after a delay of eight to 10 weeks, followed optionally by chemotherapy after six to eight weeks, or to continued on the following page

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IN THE NEWS

GENERAL SURGERY NEWS / JUNE 2021

Rectal Radiation continued from page 3

the experimental arm of 5×5 Gy radiation therapy followed by CAPOX (capecitabine plus oxaliplatin) or FOLFOX (folinic acid, fluorouracil and oxaliplatin) for 18 weeks, and then surgery after two to four weeks (Lancet Oncol 2021;22[1]:29-42). The experimental arm was superior in terms of three-year, disease-related treatment failure (24% vs. 30%; P=0.019), three-year distant metastases (20% vs. 27%; P=0.005), and pathologic complete response (28% vs.

14%; P<0.001). There was no difference in postoperative complications or number of stomas.

Dr. Van de Velde said short-course radiation therapy has better patient compliance than long-course radiation therapy, and this was evident in the RAPIDO

trial (100% vs. 93%) (Radiother Oncol 2020;147:75-83).

Another benefit of short-course radiation therapy is that it has a survival benefit in elderly patients with locally advanced rectal cancer, shown by results in 101 patients in the PRODIGE-42 study, presented at the American Society of Clinical Oncology’s Gastrointestinal Cancers Symposium (abstract 4) last January. In this trial, arm A involved preoperative long-course chemoradiation (50 Gy, 2 Gy per fraction; five fractions plus capecitabine) and delayed surgery, while arm B involved preoperative shortcourse radiotherapy (25 Gy; 5 Gy per fraction, five fractions) and delayed surgery. The inclusion criteria were patients 75 years or older with T3/T4 rectal cancer tumors. The six-month mortality rate was higher with long-course radiation

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‘So, if you get a rectal cancer, what do you want to buy? You can go to Professor Van de Velde, save a few euros, and live with a stoma or a diaper for the rest of your life, or you can spend a few dollars and go back to dignity and having fun.’

—Philip Paty, MD (10% vs. 3.92%), and the researchers concluded that short-course radiotherapy should be recommended as the new standard of care.

Dr. Van de Velde noted that shortcourse radiation therapy requires fewer visits to health care facilities, which is very important in the era of COVID-19.

“We also see in the Dutch M1 trial in metastatic rectal cancer patients and in the RAPIDO trial of locally advanced rectal cancer patients that there is a considerable pathologic complete response rate [with short-course radiation] which can be used to initiate a watch-and-wait strategy in selected patients,” Dr. Van de Velde said.

“Short-course radiation therapy is here to stay,” he said. “There are many reasons, especially now, to recommend short-course radiation therapy.”

Con: Short-Course Is Not Ready for Prime Time Philip Paty, MD, an attending surgeon in the Colorectal Surgery Service at Memorial Sloan Kettering Center, in New York City, offered a contrary opinion. “Is short-course radiation ready for prime time in rectal cancer? Absolutely not. The true story of short-course radiation is a sorrowful tale of burned bottoms, poor healing and smelly stomas.

As we say in America, you get what you pay for.”

To bolster his argument, Dr. Paty pointed to four randomized trials comparing short- and long-course neoadjuvant radiotherapy: the Polish I trial, Tasman Radiation Oncology Group trial 01.04, Polish II trial and Stockholm III trial (Br J Surg 2006;93[10]:12151221; J Clin Oncol 2012;30[31]:38273833; Ann Oncol 2016;27[5]:834-842; and Lancet Oncol 2017;18[3]:336-346).

Dr. Paty pointed out that the three Northern European trials enrolled patients with resectable cancers and made adjuvant chemotherapy optional. The Polish II trial tested long-course oxaliplatin-based preoperative chemoradiation versus 5×5 Gy and consolidation chemotherapy for cT4 or fixed cT3 rectal cancer.

“There was no impact of radiation method across the board telling us that stage and surgery were the determinants of local recurrence. Survival end points were also no different,” Dr. Paty

said. “However, we can find one measure of radiotherapy efficacy that is different between the radiation methods: the rates of pathologic complete response, which were higher following long-course radiation. We learn that long-course radiation therapy is more effective in sterilizing primary tumors than is short-course radiotherapy. Of note, quality-of-life data may not be an accurate representation because data were reported only in underpowered subsets that excluded patients with adverse outcomes (tumor recurrence, ongoing treatment), thereby excluding many of the patients most likely to have problems.”

Dr. Paty also said one clear outcome difference is found between short- and long-course radiotherapy: rates of permanent stoma. “The three trials with resectable cancers show the same trend of increased permanent stoma rates for short-course radiation.” In the Polish I trial, the rates of permanent stoma were twice as high with short-course radiation, due to more patients requiring colostomy because of impaired healing (leak, stenosis, infection and fistula) or poor anorectal function. Dr. Paty pointed out that this outcome difference is supported by pooled data from the three randomized trials studying resectable rectal cancer, which show permanent colostomy rates are higher with short-course radiation (46% vs. 36%).

Finally, Dr. Paty shared a paper from England that evaluated bowel function in a population-based study of rectal cancer patients without stomas (Int J Rad Onc Bio Phys 2018;103:1132-1142).

“Preoperative long-course radiation was bad for continence and for urgency.

Short-course radiation was even worse, with 30% fewer patients achieving complete continence. Again, we learn that the large fraction sizes and hypofractionation of short-course radiotherapy damages sphincter muscles and anastomoses,” Dr. Paty said.

Dr. Paty concluded that the four randomized trials directly comparing short- and long-course neoadjuvant radiotherapy show there is higher longterm morbidity and higher permanent stoma rates with short-course radiation.

“So, if you get a rectal cancer, what do you want to buy?” he said. “You can go to Professor Van de Velde, save a few euros, continued on page 22

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IN THE NEWS

GENERAL SURGERY NEWS / JUNE 2021

First Look: American Society of Breast Surgeons All articles by MONICA J. SMITH

Many Breast Cancer Patients Have Concerning Symptoms After Treatment About two-thirds of breast cancer patients in the United States are diagnosed early and are at low risk for dying from the disease, but many of them experience symptoms after treatment that often go unaddressed, according to new research that highlights an opportunity to improve survivorship care.

To date, most research in survivors’ symptoms has focused on later-stage patients. To assess the post-treatment symptoms of survivors with early-stage disease, Jessica Schumacher, PhD, and her colleagues administered surveys to women undergoing treatment at the University of Wisconsin Health Breast Center, in Madison.

The survey consisted of validated questions assessing breast cancer survivor symptoms and concerns, including breast symptoms, hormonal or endocrine medication side effects and adherence, lymphedema, breast and chest pain, sexual health, body image, and mental wellness.

The 94 women who completed the survey had stage I/II, estrogen receptor/progesterone receptor–positive, HER2-negative disease and were six months to six years post-diagnosis; none had undergone chemotherapy. A little more than half of the participants were younger than 65 years, and 21% were less than 50 years of age; 71% underwent lumpectomy with radiation; and 87% were currently taking endocrine medication.

In the survey, nearly all patients reported symptoms or concerns.

“Only 6% reported having no symptoms, while 16% reported one to two symptoms and 77% reported three or more,” said Dr. Schumacher, an associate professor in the University of Wisconsin-Madison’s Department of Surgery, presenting the team’s research at the 2021 annual meeting of the American Society of Breast Surgeons.

When she and her colleagues restricted symptoms to those considered clinically significant—meaning they were moderate to severe, substantially interfered with daily life, or otherwise met a validated, clinically relevant threshold—37% reported one to two symptoms and 49% reported three or more.

The most commonly reported symptoms and concerns, such as hot flashes, fatigue and back pain, are more vague and potentially not cancer-specific; a high proportion of patients, 30%, reported anxiety. More than 20% reported issues with endocrine therapy, including skipping doses.

Other significant symptoms reported by more than 10% of survivors included cough, arm swelling and pain, bone pain, extremity weakness, breast pain, and sexual health and body concerns.

Sarah Blair, MD, FACS, a surgical oncologist and professor of surgery at UC San Diego School of Medicine, said she frequently sees patients who report breast pain that makes them worry they might have a recurrence. “I wonder how we can disseminate this data to our patients so they can be reassured that these symptoms are normal and do not mean their cancer has come back.”

Dr. Schumacher said her research team, led by principal investigator Heather Neuman, MD, is working to develop reassurance messaging for survivors. They are also thinking about developing a previsit survey to identify concerns that patients and providers can focus on in follow-up visits, given the time-limited nature of these encounters.

“That’s an area of active inquiry for us,” she said.

Antibiotic Approach Does Not Predict SSI in Nipple-Sparing Mastectomy The use of broad- or dual-based antibiotic regimens in the perioperative management of patients undergoing nipple-sparing mastectomy and reconstruction appears to offer no benefit over single-agent regimens in reducing surgical site infections, according to new research.

Perioperative antibiotic coverage is recommended in patients undergoing mastectomy and reconstruction to avoid SSI, but there are questions about the adequacy of current antibiotic regimens in nipple-sparing mastectomy (NSM), in which the intact nipple-areolar complex may be a portal for gram-negative and anaerobic bacteria.

To determine the appropriate prophylactic antibiotic regimen in these patients and to examine the timing and impact of these infections, Ayat ElSherif, MD, a breast surgery research fellow at Cleveland Clinic in Cleveland, and her colleagues conducted a review of a prospective database of patients who underwent NSM and implant-based reconstruction at their institution between 2010 and 2019.

During the study period, 347 patients underwent 571 NSM surgeries with reconstruction. Of the procedures, 288 were cancer treatment and 283 were prophylactic; 259 patients (45%) received tissue expanders and 312 (55%) had direct implants. Antibiotic choice—single or dual—was at the discretion of the surgeons, most of whom prescribed a penicillin-based regimen, cephalosporin or cephalosporin/ciprofloxacin, unless the patient had an allergy.

Overall, 69 patients (12%) developed an SSI. The incidence was higher in the tissue expander group (40 cases) than the direct implant group (29 cases). In addition, the severity of SSI was higher in the tissue expander group, of whom 25 required reoperation compared with 12 in the direct implant group.

“Of those who had a culture taken, the majority were Staphylococcus species, with no difference in the type of bacteria between the tissue expander and direct implant group,” Dr. ElSherif said.

The majority of the infections, 43 of the 69, occurred within 30 days. Although the incidence decreased after 30 days, the need for reoperation rose, with 42% of patients with early SSI requiring reoperation compared with 93% of those with late-onset SSI. Patient characteristics such as higher body mass index, larger preoperative cup size and active smoker status were associated with increased risk for SSI. Infections were more common in the cancer-affected side than for prophylactic procedures, and in patients who underwent radiation and had associated nipple necrosis. Results showed neither the performing surgeon nor the antibiotic regimen were predictive of SSI. “Patient and treatment factors continue to carry the highest risk for SSI, and late-onset SSIs are more likely to require reoperation, which emphasizes the importance of continued close monitoring in patients undergoing NSM with implant-based reconstruction,” Dr. ElSherif said. She presented her study at the 2021 annual meeting of the American Society of Breast Surgeons.

Research Finds Which Intraductal Papilloma Patients Can Skip Excision New research shows certain patients with intraductal papilloma are extremely unlikely to see their disease upgrade and can be safely offered surveillance. To determine the upgrade rate at their institution, Shahrzad Abbassi-Rahbar, MD, a breast surgical oncology fellow at the University of Kansas Medical Center in Kansas City, Amanda Amin, MD, and their colleagues reviewed data from a cohort of patients diagnosed with intraductal papilloma by percutaneous biopsy between 2015 and 2020.

The investigators’ goal was to stratify patients into low- and high-risk categories according to clinical, radiographic and pathologic features to determine who would benefit from excision. Of the 416 intraductal papillomas diagnosed, 127 (30%) underwent surgical excision based on patient or surgeon preference. Of these, 15 (11.8%) upgraded, nine to ductal carcinoma in situ and six to invasive breast cancer.

“Upgrade was associated with the presence of an ipsilateral concurrent breast cancer, larger imaging size at presentation, and undersampling of a lesion, with less than 50% removed by biopsy,” Dr. Abbassi-Rahbar said. In addition, the presence of atypia was associated with a higher rate of upgrade, but was not statistically significant.

Looking at the 289 patients who did not undergo excision (69%), the researchers found none of them developed a subsequent breast cancer at the intraductal papilloma site over a median follow-up of 23.5 months. “This indicates that the upgrade rate would likely be about 2.6% if all the patients in this cohort had proceeded with surgical excision,” Dr. Abbassi-Rahbar said.

Based on their findings, the researchers determined that patients at lowest risk for upgrade are those with a small target lesion, less than 1 cm; well-done sampling, with more than 50% removed during the biopsy; and intraductal papilloma without atypia. “When these women underwent excision, 0% upgraded. Patients who meet these criteria can safely be offered observation,” Dr. Abbassi-Rahbar said.

Patients who should be offered excision include those with an ipsilateral concurrent breast cancer and intraductal papilloma with atypia. Of patients who underwent excision in this study, 41% with an ipsilateral concurrent breast cancer and 33% with atypia upgraded.

“Considerations should also be made for patients with a larger imaging target and those undersampled by percutaneous biopsy,” Dr. Abbassi-Rahbar said, presenting the study as a poster at the 2021 annual meeting of the American Society of Breast Surgeons.

Preeti Subhedar, MD, an assistant professor of surgical oncology at Emory University School of Medicine, in Atlanta, observed that the decision between excision and follow-up may give some patients pause. “It’s a hard sell to patients if a papilloma can be removed in less than 30 minutes in the OR versus coming back for imaging every six months for the next year and a half.”

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IN THE NEWS

GENERAL SURGERY NEWS / JUNE 2021

Chemo Plus Surgery Nearly Doubles Survival in Pancreatic Cancer

By MOLLY CARTER

S

urgical oncologists can extend the lives of patients with stage II pancreatic cancer by taking an aggressive multimodality treatment approach and opting for neoadjuvant chemotherapy followed by resection, according to a recent study (J Am Coll Surg 2021 Mar 26. doi:10.1016/j.jamcollsurg.2021.02.020).

Researchers at the University of Arizona examined statistics from the

National Cancer Database from 2010 to 2017, focusing on stage II pancreatic cancer patients with positive margins.

They compared patients who had R1/R2 surgery after neoadjuvant chemotherapy with those who had surgery only, those who had surgery before chemotherapy and patients who only received chemotherapy. The results aligned with the current standardized approach, demonstrating that chemotherapy before surgery gives most patients more time.

REPROCESSED VESSEL SEALING DEVICES HAVE VISIBLE CONTAMINATION ON THEM.1,† A study published in Surgical Endoscopy raises questions about the sterility of reprocessed vessel-sealing devices

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FAILED ACROSS A MIX OF 4 DIFFERENT TESTS THAT CHECKED FOR ORGANIC MATERIAL1,‡

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166X

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PASSED THE TESTS

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Learn more about OEM LigaSure™ technology and our risk-sharing and LQGHPQLƬFDWLRQ SURJUDPV RQOLQH at medtronic.com/vesselsealing

© 2020 Medtronic. All rights reserved.

10/2020 – US-SE-2000158 – [WF# 4604546]

96%

IN THE SAME STUDY, OEM LIGASURE™ DEVICES

Read the full study here.

Medtronic does not manufacture, distribute, warrant, or indemnify reprocessed LigaSure™ vessel sealing devices. To quickly determine if a LigaSure™ device from Medtronic is inauthentic, check the packaging, the product, and the plug. If there’s a logo other than Covidien™ or Valleylab™, it’s not an authentic device from Medtronic.

For some patients, this multimodality approach nearly doubled their life expectancy, with those who received neoadjuvant chemotherapy before surgery living an average of 19.75 months compared with 10.12 months for patients who only received chemotherapy.

OF THE TIME.1 †Contamination was found following disassembly of the devices and jaws. The study found that 52% of reprocessed devices studied had visible contamination. The remaining 48% did not have contamination that was visible to the naked eye. ‡The combination of failed tests included visual inspection, optical and scanning electron microscopy, hemoglobin detection, and sterility testing. §Sterility assurance level of 10-6 accepted by the FDA as laid out in the Association for the Advancement of Medical Instrumentation (AAMI) standards ST67 and TIR 12 for devices contacting normally sterile tissue.

1. Chivukula, S.R., Lammers, S. & Wagner, J. Assessing organic material on single-use vessel sealing devices: a comparative study of reprocessed and new LigaSure™ devices. Surg Endosc (2020). https://doi.org/10.1007/s00464020-07969-8.

“The gold standard is R0 or R-negative, but you don’t need that gold standard to see benefits from surgery,” according to lead study author Amanda Arrington, MD, FACS. “Even when the resection isn’t the best-case scenario, surgery can still double the life expectancy of patients. It’s a package. It’s not just surgery. It’s not just chemo or radiation. It truly is multimodality. Pancreatic cancer must be addressed as a team to offer the best patient outcomes. With that team effort, it can improve survival.”

The study shows that regardless of how the researchers analyzed the data, the benefit of neoadjuvant chemotherapy before surgical resection remained, even when the patient was determined to have a margin-positive disease. When discussing the possibility of outside factors or comorbidities, Dr. Arrington, a surgical oncologist in the Department of Surgery at the University of Arizona in Tucson, said, “No matter how you slice the data, surgery is important. It shows surgery following chemo is beneficial to pancreatic cancer patients. It should be the standard of care in stage II and stage III pancreatic cancer treatments. I expect to eventually see surgery plus neoadjuvant chemotherapy translate into stage I pancreatic cancer treatment.”

The study elaborates on the benefits of modern chemotherapeutic regimens and demonstrates that they improve patient survival rates, even when the tumor appears unresectable. In one-third of pancreatic cancers that were considered borderline resectable, the surgery resulted in R0 when it occurred after neoadjuvant therapy.

General Surgery News spoke with Ronald Matteotti, MD, FACS, the Charles & Jackie Adell Chair in Surgical Oncology at Hackensack Meridian Health, in New Jersey, who agreed. “The international trend is to use neoadjuvant chemotherapy before surgery. It not only shrinks the tumor, but it also helps in other ways, such as reducing the risk of fistulas.”

The research discussed how radiological images can fail to consistently show the benefit of neoadjuvant chemotherapy and, therefore, may misdiagnose a resectable tumor as borderline or locally advanced.

Because these images aren’t reliable, and due to the aggressive nature of pancreatic cancer, most of today’s surgical oncologists opt for exploration and attempted resection—even in tough cases. Dr. Matteotti agreed: “You can’t rely on radiologic evaluation. With only a 1-mm interface, things can be missed.” He confirmed that “stage II pancreatic cancer should be con■ sidered a surgical disease.”

IN THE NEWS

JUNE 2021 / GENERAL SURGERY NEWS

How Acute Care Surgery Team Managed the COVID-19 Surge

By VICTORIA STERN

W

hen COVID-19 began to surge in the United States in March 2020, hospitals had to act quickly. The acute care surgery (ACS) team at Tufts Medical Center, in Boston, was no exception.

“We felt a sense of urgency to prepare our hospital for an influx of critically ill patients,” said Horacio M. Hojman, MD, the chief of the Division of Trauma and Acute Care Surgery and surgical director of the Surgical Intensive Care Unit at Tufts University School of Medicine. “As trauma surgeons, we see emergencies every day and are trained to come up with a plan fast.”

Despite limited information about the coronavirus, the four-surgeon team quickly pivoted their normal operations to meet the moment. First, the surgeons devised a system to separate COVID-19‒positive and uninfected patients into two surgical ICUs, and to provide around-the-clock coverage of trauma, emergency general surgery and surgical critical care patients, leaving a handful of surgeons in reserve in case anyone got sick.

“Many of those systems were created on the spot by extrapolating from our disaster preparedness plan deployed during the Boston Marathon bombing, military training, and the experiences our colleagues in Italy and China had with COVID19 even earlier in the pandemic,” said Nikolay Bugaev, MD, the executive director of research in the Department of Surgery and an assistant professor of surgery at Tufts University School of Medicine.

“We saw our colleagues across the country and the world facing a similar challenge, and decided to document our experience to understand how well our disaster planning worked.”

In late November, Drs. Hojman and Bugaev, and their colleagues published a review comparing patient demographics, needs and outcomes two months before and after the March 2020 COVID-19 surge to assess their system and provide a guide for others (Am Surg 2020;86[12]:1629-1635).

The authors found that during the initial surge months, trauma and emergency general surgery volumes at Tufts dropped by about 51% overall, while critically ill patient volumes increased by 64%.

Between March and May, the needs of patients admitted to the ICU also shifted. Overall, the majority of people admitted to the surgical ICU were not surgical patients. The surgeons tracked the types of procedures performed and reported that, in the months before COVID-19 hit, emergent laparotomies were the most common procedure encountered by the ACS team (35%), but during the surge that shifted to tracheostomies and percutaneous endoscopic gastrostomies (36%).

To protect clinicians from aerosolized particles during tracheostomies, the surgeons created a localized negative-pressure environment by overlaying the top of the bed with a plastic, nonsterile sheet and connecting an air filter (Am Surg 2020 Dec 7).

Of note, the surgeons found that hospital mortality did not differ significantly between the pre‒COVID-19 and surge groups (9.6% vs. 13.4%, respectively; P=0.4) or between critically ill COVID-19

patients treated by ACS and non-ACS ICUs during the surge (13.4% vs. 13.5%, respectively).

“I was pleased at our great results,” Dr. Bugaev said. “The ACS service was able to apply general emergency concepts and escalate them rapidly in order to continue providing trauma and emergent surgical services during the surge, while also delivering intensive medical care to nonsurgical patients.”

Six weeks into the new system, the influx

of COVID-19‒positive patients began to plateau and the ACS service gradually deescalated its disaster plan. With this experience, Drs. Hojman and Bugaev now feel prepared if there is a next time.

“After creating and implementing this self-sustaining emergency plan, I think we’re better equipped to handle an emergency of this magnitude,” Dr. Hojman said.

“We were lucky that our expertise managing disaster scenarios could be put to good ■ use during the pandemic.”

9

THE SCIENCE BEHIND POSITIVE PATIENT OUTCOMES

Tri-Staple™ 2.0 Reinforced Reloads: Preloaded Buttressing for Bariatric Procedures Alfonso Torquati, MD, MSCI Bariatric Surgeon Rush University Medical Group Chicago, Illinois

Advances in Staple Line Reinforcement Staple line buttressing is increasingly recognized as a standard of care for an array of thoracic, abdominal, and gastrointestinal resections.1-3 In fact, the majority of bariatric surgeons were using buttressing for sleeve gastrectomies by 2013,3 and multiple bariatric surgery studies associate staple line buttressing with a reduction in complications, particularly bleeding.4,5 Over the past several years, device manufacturers have advanced the materials and device design to optimize strength and seal, and improve procedural efficiency.6 The incorporation of 3 staple lines and preloaded buttressing material are among the most significant of these advances.7 Alfonso Torquati, MD, MSCI, a bariatric surgeon at Rush University Medical Group, in Chicago, Illinois, reinforces the staple line in gastric bypass, sleeve gastrectomy, and revision procedures. Dr Torquati has witnessed the evolution of the technology throughout his career, and although he has extensive experience with numerous stapling devices, he has used the Tri-Staple™ 2.0 reinforced reload (Figure 1) almost exclusively from the time of its introduction and for every case. “When I joined the practice at Rush, we were buttressing with both of the staplers we had available, but it wasn’t long before all the bariatric surgeons switched to the Tri-Staple™ device,” Dr Torquati said.

proper alignment,” he said. “It means more efficiency during the procedure.”8,a

The Technology Reload Size Tri-Staple™ 2.0 reinforced reloads provide the benefit of individualized color-coded staple loads.

The black cartridge is appropriate for extra thick tissue, and has staple heights ranging from 4.0 mm in the innermost row to 4.5 and 5.0 mm in the middle and outer rows, respectively. The purple cartridge is designed for medium/thick tissue and provides staple heights of 3.0, 3.5, and 4.0 mm. Both black and purple cartridges are available in 45 and 60 mm lengths. Dr Torquati says he starts with the black loads in most patients and, as appropriate, moves to purple loads for thinner tissue. Occasionally in thick tissue, he will fire 2 staple lines from black cartridges.

Dr Torquati thinks the ability to adjust to tissue thickness represents an important advance in initial bariatric surgeries as well as revisions, which represent a significant proportion of his cases. He typically uses the black reload when tissue is thickened by inflammation to ensure adequate reinforcement. “Different loads allow me to adjust the closure to the patient’s anatomy, while the variable height adds strength without impairing the vascularization needed for healing,” Dr Torquati said.9,10,b-d

The Material Relative to composite materials, the polyglycolic acid buttressing material used in the Tri-Staple™ 2.0 reinforced reload device was developed with small uniformly packed fibers, resulting in less material mass at implantation with greater strength,9,b,c and according to Dr Torquati, this represents an important advance. “This current material is flexible. It is stable but resorbs readily,” he said. “In my experience, it is very well tolerated.” Dr Torquati estimates that extra reinforcement, such as oversewing, is required in fewer than 1 in 20 of his cases. “An example might be very thick tissue close to the duodenum,” he said. “We might also consider a clip for larger vessels when we see oozing, but these are uncommon situations.” He added: “The combination of the buttressing material and the 3 rows of staples means it is rarely necessary to use additional reinforcement.”

Reduced Bleeding11,e The strength of the closure with Tri-Staple™ 2.0 reinforced reloads is reflected in a “solid” quality at the staple line, according to Dr Torquati. “When attempting to move tissue following closure, there was always a risk of bleeding in the absence of reinforcement.

With Tri-Staple™ closures, there is less concern about pulling the tissue in order to move it into view,” he said. “The reduction in intraoperative bleeding provides better visualization of the surgical field.11,f Less bleeding means less time clearing the field. Better visualization as a result of less bleeding allows me to

Efficiency Tri-Staple™ reinforced reloads are the only reloads that come with prefixed buttressing, which speeds operating time (Figure 2). In fact, a survey of 250 surgeons and nurses found that using a preloaded buttress saved 7 to 10 minutes compared to a separately loaded buttress.8,a According to Dr Torquati, several devices incorporate methods to facilitate loading of the buttressing material, but additional steps can introduce chances for error. “Our OR scrub technicians are much happier with the Tri-Staple™ reinforced reloads. They no longer spend time pulling strings or taking the other required steps to ensure

10

GENERAL SURGERY NEWS • JUNE 2021

Figure 1. Tri-Staple™ 2.0 reinforced reloads.

Figure 2. Tri-Staple™ reinforced reloads are the only reloads that come with prefixed buttressing.

Supported by

Figure 3. Tri-Staple™ 2.0 reinforced reloads with the smart Signia™ stapler. ascertain during the procedure whether I am achieving a good staple formation.”

Research indicates that buttressing (vs not buttressing) the staple line in bariatric surgery is associated with a 30% reduction in postoperative bleeding,12 and Dr Torquati has found that his bleeding rate is at least as low as what has been reported in the literature since adopting the Tri-Staple™ 2.0 reinforced reloads. His leak rate is even lower.

“Leaks can be a more serious complication than bleeding, but they are rare,” Dr Torquati said. In fact, he has had none in his series and attributes this absence of leaks to his reliance on staple line reinforcement.

“We perform an endoscopy after every procedure to confirm the quality of the closure within the lumen of the stomach. We have consistently seen good hemostasis. I have not yet needed to perform additional steps on the basis of the endoscopic view,” he said.

Smart Technology The Tri-Staple™ 2.0 reinforced reload has a stepped cartridge face that provides gradual compression across tissue types. Many bariatric surgeons use the reload with the Signia™ stapler, which automatically adjusts speed to improve staple formation when forces increase in challenging applications (Figure 3).13,14,g Dr Torquati prefers to staple without smart technology when demonstrating the fundamentals of closure to his fellows, but he is quick to recognize the advantages of using the technologies together. The Signia™ stapler is fully powered, and he likes the audible feedback and variable speed functions it offers. “With thicker tissue, it is helpful to close at a slower pace,” he said. Manufacturer studies have found that adjusting the speed of firing in different tissue thicknesses can reduce the percentage of malformed staples.13-15,g Dr Torquati is also enthusiastic about the advantages of smart stapler technology for less experienced surgeons. “It’s important to select the appropriate staple size. Staplers that help

The progress in stapling technology for bariatric surgery has substantially reduced patient complications and improved the surgeon’s experience.6-8,12,a Dr Torquati believes the Tri-Staple™ 2.0 reinforced reload features create procedural efficiencies,a provide adequate strength,g,h and permit the blood supply necessary for healing.8,10,17,d For him, strength at the closure line means less intraoperative bleeding and fewer postoperative complications.11,18,f Dr Torquati thus relies on the Tri-Staple™ 2.0 reinforced reload for weight loss surgery. a

Compared with an aftermarket buttress. Results based on a sample of 125 OR nurses and 125 surgeons.

b

In vitro tensile strength compared with Seamguard™ at days 7 and 14.

c

Bench test results may not necessarily be indicative of clinical performance.

d

Compared with flat-faced cartridges with single-height staples.

e

Compared with nonbuttressed reloads.

f

Based on international consensus of an expert panel of bariatric surgeons.

g

Preclinical results may not correlate with clinical performance in humans.

h

Based on a benchtop comparison at 0 and 7 days in vivo (2 sample t-test: P=0.000 and 0.0007).

References 1. Deguchi H, Tomoyasu M, Shigeeda W, et al.

Reduction of air leakage using linear staple device with bioabsorbable polyglycolic acid felt for pulmonary lobectomy. Gen Thorac Cardiovasc Surg.

2019;68(3):266-272.

2. Shigeeda W, Deguchi H, Tomoyasu M, et al. The utility of the stapler with PGA sheet for pulmonary wedge resection: a propensity score-matched analysis.

J Thorac Dis. 2019;11(4):1546-1553.

3. Gagner M, Deitel M, Erickson AL, et al. Survey on laparoscopic sleeve gastrectomy (LSG) at the Fourth International Consensus Summit on Sleeve Gastrectomy. Obes Surg. 2013;23(12):2013-2017.

4. Gill RS, Switzer N, Driedger M, et al. Laparoscopic sleeve gastrectomy with staple line buttress reinforcement in 116 consecutive morbidly obese patients. Obes Surg.

2012;22(4):560-564.

5. Shikora SA, Mahoney CB. Clinical benefit of staple line reinforcement in gastrointestinal surgery: a meta-analysis. Obes Surg. 2015;25(7):1133-1141.

7. Moussaoui IE, Limbga A, Mehdi A. Staple line reinforcement during sleeve gastrectomy with a new type of reinforced stapler. Minerva Chir.

2018;73(2):127-132.

8. Data on file. Medtronic. ORC International. Survey of tissue reinforcement users to determine waste and time loss attributed to separately loaded buttress materials in the OR. Online U.S. national sample of 125 surgeons and 125 OR nurses. November 9, 2011.

9. Data on file. Medtronic. Internal report #RE00240873.

Mass, thickness, area measurements, pH measurements, and glycolic acid released for polyglycolic acid buttress (PGA) and Seamguard™ buttresses. [Reinforcement buttress material tested using 2-sample t-tests. Data calculated with 95% confidence using Minitab™ (P<0.0001)]. December 2, 2019.

10. Data on file. Medtronic. Internal test report #2128-002-2. Final analysis of staple-line vascularity using MicroCT. July 2015.

11. Rosenthal RJ, Diaz AA, Arvidsson D, et al. International Sleeve Gastrectomy Expert Panel consensus statement: best practice guidelines based on experience of >12,000 cases. Surg Obes Relat Dis. 2012;8(1):8-19.

12. Zafar SN, Felton J, Miller K, et al. Staple line treatment and bleeding after laparoscopic sleeve gastrectomy.

JSLS. 2018;22(4):e2018.00056. doi: 10.4293/ JSLS.2018.00056 13. Data on file. Medtronic. Internal test report #R2146-173-0. ASA verification testing with slow speed force limit evaluation. 2015.

14. Data on file. Medtronic. Internal test report #R2146-151-0. Powered stapling firing speed DOE analysis and ASA parameters. 2015.

15. Data on file. Medtronic. Internal test report #RE00218740. Signia™ stapling adaptive firing technology data calculations and references.

August 7, 2019.

16. Data on file. Medtronic. Internal test report #RE00055515. Surgeon evaluation testing Signia™ stapling system sensing technology and real-time feedback. August 4, 2016.

17. Data on file. Medtronic. Internal test report #RE00088418. In-vitro tensile strength comparison.

April 11, 2017.

18. Nagahisa Y, Morikawa A, Kato T, et al. Feasibility of Endo GIA™ reinforced reload with Tri-Staple™ Technology for delta-shaped anastomosis.

Asian J Surg. 2018;41(5):448-453.

Disclosure: Dr Torquati reported receiving honoraria from Medtronic.

Disclaimer: This is one physician’s experience, results, and recommendations, so results may vary. Please see the package insert for the complete list of indications, warnings, precautions, and other important medical information.

GENERAL SURGERY NEWS • JUNE 2021

04/2021-US-ST-2100051

Conclusion

6. Chekan E, Whelan RL. Surgical stapling device—tissue interactions: what surgeons need to know to improve patient outcomes. Med Devices (Auckl). 2014;7:305-318.

BB212

surgeons assess tissue thickness will be a big help for those developing skill in bariatric surgery,” he said.16,c

11

OPINION

On Learning to Land continued from page 1

I fly a Cessna 172, a single-engine plane that can seat four adults uncomfortably, with my flight instructor, Brian, who is in his mid-30s, tall and bald by choice. He used to be a high school football coach but is built more like a basketball player. He’s unassuming, mildmannered and not shy. In a recent lesson, he decided it was time for me to practice landings. We flew to a small airfield outside of Nashville, Tenn., where traffic is sparse, and the radio communication requirements are minimal. We arrived with a plan to practice “touch and go’s” all day: entering the traffic pattern, landing on the field, then quickly taking off again, and repeating. The weather was nice, the winds were smooth, and the airspace was empty. But despite these near-perfect conditions, I struggled to land safely. While Brian didn’t say anything, I could feel he was adjusting the flight controls as I made my approaches so we would land safely. After my sixth attempt with the same bumpy result, I was frustrated and surprised that Brian hadn’t said anything up to that point. So, I finally just asked him: What am I doing wrong here? All he said was, “I think you want the plane on the ground too badly.”

One of the more interesting ethical questions that surgical training presents stems from the perception of tension between patient safety and effective surgical training. If developing surgical skills requires the novice to develop those skills while caring for a patient, how do we protect the patient from the risk inherent from a novice’s skills?

When I was a resident, I felt the effects of this tension much differently from what I do now as a surgeon recently accused of being mid-career. This makes sense, too: As a trainee, my goal was to evolve from a novice to an expert.

I wanted my future patient to be cared for by the kind of surgeon every patient has a right to see: a competent surgeon.

I think it’s clear, at least in my experience, that the trainee bears a great deal of the moral weight that arises from thinking about the future patients they will expose to the knife. But does the training surgeon bear some of this weight, too? I think I’ve always considered my duty as surgical educator as a duty to the trainee—the surgical resident. But where does that duty really get its moral power? If not from the future patient, then where? And if that’s the case, are the ethics that shape my clinical practice as a surgeon formed not just by the obvious obligation I have to the patient on the operating room table today, but also that future patient who will be on this trainee’s table someday, too?

The funny thing about landing a plane, in my experience, is that it takes

a completely different mindset from any other aspect of flying. It’s a balance of controlling the orientation of the aircraft while making fine adjustments in the throttle so you start falling. It feels, at least to me, like you’re trying to convince the airplane it’s still flying while making subtle adjustments that bring it closer to the earth without making you feel like you’re falling from the sky. You have to get this thing that is designed to fly—it wants to go up—and get it to go

down. It’s not an obvious skill to develop. Part of what makes it less than obvious is because the best way to land is as much about what you don’t do as it is about what you do. As challenging as it is to learn, my instructor’s challenge is as acute a dilemma as I can imagine. He has to let me learn enough that I can eventually do this on my own, which means he has to let me do some of it on my own.

In essence, he has to allow me to make as many errors as necessary for me to learn, while keeping me from killing both of us.

There is a famous thought experiment that ethicists, like me, love to invoke

It’s not enough to become the best surgeon; the moral duty isn’t honored until we consider the ways in which we are caring for the future patient, too.

S

12

L I

OPINION

whenever possible. It’s called the “Trolley Problem.” Originally described by the philosopher Judith Jarvis in 1967, the trolley problem essentially goes like this: Imagine a train track that splits into two directions. In one direction, there is a single person tied to the tracks, and in the other direction, there are five people tied to the tracks. Imagine also that there is a trolley that is barreling down the main track and is heading directly toward the five people. Now imagine you are standing next to a lever, that if pulled will redirect the trolley away from the five people on the track and toward

the track with the one person tied there.

There is no way to communicate with the trolley to stop. What would you do?

The trolley problem is a perfect analogy to surgical training as long as we consider patient safety as antagonistic to effective surgical training. As we shelter patients from surgical trainees in the name of patient safety, we put at risk all the future patients they will treat as a surgeon in the future. We’ve seen the effects of this over the course of years. Ever since Mike Wallace’s “60 Minutes” program exposed the realities of surgical training, the resulting oversight and subsequent

constraints on surgical trainees have been significant. But so has the effect on producing competent general surgeons. In one study of recent graduates, 38% could not perform a laparoscopic cholecystectomy by themselves. What do you call a general surgeon who can’t do a lap chole?

I don’t know, either.

But what if we’re thinking about this incorrectly? When I’m flying with Brian, the safest way to land the plane is to let Brian do it. But then how do I reach the part where it’s safe to send me up there on my own? At some point, every flight instructor must make a call about whether their student can solo: the process of stepping out of the airplane and letting their student take off and land by themselves. Usually, the instructor gets out of the cockpit and waits on the tarmac with a handheld radio and watches the whole thing take place. Instructors take this part of their job with incredible earnestness. A failure of effective training or judgment is a failure of the highest order. And the ownership and moral responsibility for that failure is clear and immediate in-flight instruction. Is surgical training any different?

For whatever reason, when Brian told me, “I think you want the plane on the ground too badly,” something clicked. I knew what I needed to do to get the plane safely on the ground, and as I entered the final leg of the traffic pattern, I lined up on the center line, I adjusted the power to let the plane slowly lose altitude, and I adjusted the nose of the airplane to bring us down near the numbers. Then we got to a few feet off the ground, I brought the throttle back to idle, and as we floated down the runway, I resisted the urge to push the nose down, and instead settled in and just let the plane come down on its own. It was as smooth a landing as I had ever experienced in a small plane. Brian had kept his hands and feet off the controls completely. All he said was, “You can fly on your own if you fly like that.”

The truth is the surgeon’s obligation is to the patient on the table in front of them today and that obligation has a weight of almost religious proportions, established in tradition and culture and history. I would argue, though, that we haven’t considered enough the ways in which that obligation extends to the future patients of our current surgical residents. Sometimes we conflate a responsibility to our trainees when what we really mean is a moral obligation to their future patients. Thinking about my ethical duties in this way has changed my perception of the moral duty of this role.

It’s not enough to become the best surgeon; the moral duty isn’t honored until we consider the ways in which we are caring for the future patient, too. continued on page 22

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GENERAL SURGERY NEWS / JUNE 2021

Workup and Management of Esophageal Cancer QUESTION for Frederick D. Cason, MD, FACS From Ying Ming BenTan, MD, PGY-4, general surgery resident, San Joaquin General Hospital, French Camp, Calif.

Welcome to the June issue of The Surgeons’ Lounge. In this issue, our guest expert, Frederick D. Cason, MD, FACS, the program director of the general surgery residency at San Joaquin General Hospital in French Camp, Calif., discusses esophageal cancer. Also in this issue, “The Procedure, The Name” features the Ivor Lewis esophagectomy.

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

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

A 35-year-old man presented with four months of worsening dysphagia, an associated 70-pound weight loss, acute severe chest pain and crepitus in the neck. A CT scan showed dilatation of the thoracic esophagus leading to a mass-like thickening at the distal thoracic esophagus and pneumomediastinum, suspicious for esophageal rupture. An esophagram with gastrograffin contrast demonstrated complete occlusion of the distal esophagus with proximal esophageal dilatation. No leak was noted.

Esophagogastroduodenoscopy (EGD) just prior to thoracotomy showed complete obstruction of the distal thoracic esophagus (32 cm from the incisors) by a malignant mucosal tumor. The scope could not be advanced into the obstructed lumen. An Ivor Lewis esophagogastrectomy (right posterolateral thoracotomy, laparotomy with mobilization of a gastric tube and abdominal lymph node dissection, and jejunostomy tube placement) was performed the next morning after volume resuscitation, initiation of deep vein thrombosis prophylaxis and administration of antibiotics. Intraoperative findings included a large obstructing distal esophageal mass with metastatic juxta esophageal mediastinal and left gastric pedicle lymph node metastasis. The final pathology showed a T3N3M0 G3 poorly differentiated adenocarcinoma with all 26 recovered lymph nodes positive. Margins were negative.

The postoperative course was complicated by a chyle leak presenting initially as a left pleural effusion, which spontaneously closed after three weeks of conservative management with octreotide, total parenteral nutrition and bowel rest. The patient recovered well, and has been tolerating a solid diet without dysphagia and is gaining weight.

• Could you give an introduction in the epidemiology and pathogenesis of esophageal cancer?

• What is your workup for esophageal perforation?

• What are the differences in approaches to iatrogenic or spontaneous esophageal perforation versus perforation in the setting of malignancy?

• What are the different surgical options in an esophagectomy?

• What are some tips to keep in mind when performing an esophagectomy?

• Do you have any tips regarding postoperative management?

Dr. Cason’s REPLY Could you give an introduction in the epidemiology and pathogenesis of esophageal cancer?

Esophageal cancer is an important malignant disease in the world.

The American Cancer Society estimates that there were approximately 18,400 new esophageal cancer cases diagnosed in 2020.1 More than 14,000 were men and approximately 4,000 were women. It makes up about 1% of all cancers diagnosed in the United States. Adenocarcinoma is the most common type. During my training, I never saw an adenocarcinoma of the gastroesophageal (GE) junction; most of the cancers were squamous cell carcinoma of the thoracic esophagus. In the 1960s, 90% of them were squamous cell carcinoma, whereas now 80% are adenocarcinoma.2,3 Esophageal adenocarcinoma tends to affect middle-aged and overweight white men. Risk factors for getting this disease include obesity, gastroesophageal reflux disease, smoking and alcohol consumption. Barrett’s metaplasia is also a risk factor. About 20% of patients now survive at least five years.4 In the 1960s and 1970s, only about 5% did so.

What is your workup for esophageal perforation?

A contrast swallow study is the gold standard for evaluation of esophageal perforation. Regarding EGD, one must balance the possibility of seeding the mediastinum or the pleura with infection and tumor with the extent

of information potentially obtained by the endoscopic procedure. I personally perform endoscopy just prior to operation in the patient I have already decided needs an operation. Endoscopy prior to incision is important to delineate the anatomy, the length of uninvolved esophagus, the extent of dilatation of the esophagus, pathologic changes like strictures or synchronous neoplasms, or any food content or bezoars that may be present. A CT scan can provide useful information such as pathologic changes of the esophagus, size of the mass, regional lymphadenopathy, involvement of adjacent structures, thoracic metastatic disease, and the presence or absence of subcutaneous emphysema or pneumomediastinum.5 CT is frequently helpful in suggesting the degree of contamination of the mediastinal or pleural spaces.

What are the differences in approaches to iatrogenic or spontaneous esophageal perforation versus perforation in the setting of malignancy?

Most perforations are due to instrumentation by EGD and occur at areas of narrowing or strictures, or by overzealous instrumentation of a tumor or benign stricture. Barogenic perforation or Boerhaave syndrome is typically in an alcoholic patient who is intoxicated and has been vomiting. Eructation and a sudden increase in intrathoracic pressure leads to an esophageal tear, which is typically longitudinal and on the left. Much less common is the spontaneous perforation of a malignant tumor of the esophagus.

The decisions about operative or nonoperative management can be based on whether the perforation is

contained in the periesophageal tissues or leaks into the pleura and the extent of mediastinitis. The field of nonoperative management with stenting is evolving and may include chest tube drainage, antibiotics, nasoesophageal tube decompression and observation.6 Classic operative management includes esophageal debridement and primary repair with drainage. Closure of the ends of the esophagus with proximal pharyngeal diversion or exclusion is reserved for the patient with severe, life-threatening mediastinitis and esophageal tissue not amenable to repair. Repair of the esophagus over a T-tube is an option. In the circumstance of underlying esophageal disease (such as achalasia) or malignancy, esophageal resection is usually required and desired. In esophageal malignancy without perforation, stenting is a bridge that allows the patient to be able to be nourished while getting neoadjuvant chemoradiation therapy. There are unanswered questions about stenting in the patient with perforation in malignancy. One must take into consideration how sick the patient is, how much mediastinitis the patient has, and the potential complications that could delay future chemoradiation. It is difficult to predict the direction of mediastinitis once the mediastinum has been contaminated.

What are the different surgical options in an esophagectomy?

Three of the most common options for an esophagectomy are the two-stage Ivor Lewis esophagectomy, transhiatal esophagectomy without thoracotomy, and a three-field McKeown total thoracic esophagectomy. All

SURGEONS’ LOUNGE

JUNE 2021 / GENERAL SURGERY NEWS

these procedures can be perpatients have a patulous formed by minimally invaGE junction or may have sive techniques in the hands a hiatal hernia precluding of experienced surgeons. the necessity to make this The Ivor Lewis esophagecmaneuver. tomy has an abdominal and For the thoracotothoracic phase, with the my phase of the operathoracic portion normaltion, you enter the right ly performed through the chest through the fifth or right chest. This is usualsixth intercostal space. The ly preceded by laparotomy, esophagus is mobilized gastric tube mobilization, from the mediastinum takpyloromytomy or pyloing the small branches roplasty, and lymph node coming directly from the dissection along the lessaorta (I use clips), and diser curvature of the stomach secting all the lymph nodes and crural region. The open Figure 1. Esophageal specimen. Figure 2. Open end of esophagus Figure 3. Tension-free gastric tube. along the esophagus to above divided azygous vein. transhiatal esophagectomy above the level of the azyinvolves an abdominal disgous vein (Figure 1). I ususection, transhiatal blind mobilization of the esophagus, gastroepiploic vessels. On the side of the lesser curva- ally divide the azygous vein (Figure 2) to easily mobilize a left neck incision with mobilization of the cervical ture of the stomach, the left gastric artery and vein and the esophagus, and this gives an excellent proximal maresophagus, removal of the tumor through the abdom- lymphatic drainage should be completely dissected and gin—I try to obtain a 10-cm margin. inal incision, gastric pull-up and a cervical anastomo- taken with the specimen. This dissection should extend Reconstruction of the esophagus is achieved by stansis. The McKeown esophagectomy involves steps similar from the celiac to the crural, subdiaphragmatic and dard anastomosis, with which the individual surgeon is to an Ivor Lewis esophagectomy with an additional left lower mediastinal lymph nodes. The duodenum should familiar. I use a two-layer anastomosis of the end of the neck incision; total thoracic esophagectomy, which avoids be mobilized by a Kocher maneuver to give length to esophagus to the side of the proximal gastric tube (Figa thoracic anastomosis; and the cervical anastomosis. the gastric tube so that it can be brought into the chest ure 3). I use through-and-through interrupted absorbable easily and without tension. Pyloromotomy or pyloro- sutures, then 3-0 silk seromuscular sutures for the exterWhat are some tips to keep in mind when performplasty typically is performed, although some believe it nal row. (The esophagus has no serosa; good muscular ing an esophagectomy? is not necessary. Personally, I always try to perform a bites are taken.) A mediastinal chest tube is placed and The patient with adenocarcinoma of the distal pyloromyotomy. You can also perform a Heineke-Miku- brought out through the lower right chest, as is a pleural esophagus (Siewert type I) should be treated by a two- licz pyloroplasty. Care must be taken to avoid missing an chest tube placed at the apex of the pleura. field operation to achieve adequate margins, satisfacto- entry into the duodenal mucosa during pyloromyotomy ry mediastinal lymph node dissection and anastomosis. to avoid the complication of a postoperative leak.

Do you have any tips regarding postoperative Care must be taken to not injure the blood supply It may be helpful to cut the right or left crus of the management? to the gastric tube during abdominal mobilization and diaphragm if the hiatus is tight, and resection of a cuff of Most patients with an anastomosis in the chest that continued on the following page the spleen should not be injured during division of the tissue there may provide a good oncologic margin. Some

THE PROCEDURE, THE NAME: THE IVOR LEWIS ESOPHAGECTOMY

By Lisandro Montorfano, MD, PGY-4 general surgery resident, and Mauricio Sarmiento Cobos, MD, research fellow, Cleveland Clinic Florida, Weston

The Ivor Lewis esophagectomy is one of the surgical procedures of choice for patients diagnosed with esophageal cancer. In 1946, Dr. Lewis made one of the most important contributions to foregut surgery by performing the first Ivor Lewis esophagectomy.

Dr. Lewis was born in 1895 in Llanddeusant, Wales. He completed his medical studies at University College Hospital, London, and served as a general surgeon at the City Hospital in Plymouth at the beginning of his career. In 1933, Dr. Lewis moved back to London to work as a surgeon and the medical director at North Middlesex Hospital. During his training, he was strongly influenced by the famous medical doctors from the early 1900s, including Drs. Wilfred Trotter and Gwynne Williams.

The Ivor Lewis esophagectomy technique was carefully described by Dr. Lewis.

The procedure was divided into two stages. The first stage consisted of a laparotomy, with exclusion of metastases, followed by a jejunostomy to feed the patient for approximately 15 days.

The second stage consisted of a right thoracotomy for esophageal resection and lymphadenectomy, followed by an intrathoracic anastomosis of the gastric conduit to the proximal esophagus at the level of the proximal mediastinum. One of the key Figure. Ivor Lewis esophagogastric anastomosis.

steps of this operation, according to Dr. Lewis, was to create a tension-free esophagogastric anastomosis.

Initially, this procedure was performed through an open approach, but in more recent decades, with the advent of endoscopy, laparoscopy and robotic surgery, these open operations rapidly became outdated and were replaced by minimally invasive approaches, showing faster recovery times and less morbidity. Not surprisingly, the Ivor Lewis esophagectomy has managed to maintain its status as one of the preferred minimally invasive surgical approaches for esophagectomy in patients with esophageal cancer.

Suggested Reading Huang L, Onaitis M. Minimally invasive and robotic Ivor Lewis esophagectomy. J Thorac Dis. 2014;6(suppl 3):S314-S321.

Lewis I. The surgical treatment of carcinoma of the oesophagus with special reference to a new operation for growths of the middle third. Br J Surg. 1946;34:18-31.

Morris-Stiff G, Hughes LE. Ivor Lewis (1895-1982)—Welsh pioneer of the right-sided approach to the oesophagus. Dig Surg. 2003;20(6):546-553.

Roberts A. LEWIS, IVOR (1895-1982), consultant surgeon. Dictionary of Welsh Biography; 2015. Accessed January 24, 2021. https://biography.wales/article/s10-LEWI-IVO-1895 Watson DI, Davies N, Jamieson GG. Totally endoscopic Ivor Lewis esophagectomy. Surg Endosc.

1999;13(3):293-297.

Zorrilla-Nunez LF, Rosenthal R, Montorfano L, et al. Management of gastric conduit necrosis after laparoscopic Ivor Lewis esophagectomy. Presented at: SAGES Annual Meeting; March 22-25, 2017; Houston, TX. Abstract 87391.

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OPINION

GENERAL SURGERY NEWS / JUNE 2021

A Very Special Place

By FREDERICK L. GREENE, MD

A

s the pandemic begins to wane and the percentage of those vaccinated increases, we have the ability to foray out of the enclaves in which we have been cocooned for over a year. For me, travel to the mountains of North Carolina has been a true panacea, and, as I write this, I am enjoying another magnificent setting in this part of the state. Personally, there is nothing more serene than spending time in the North Carolina mountains. Especially during the past year, ventures of two to three hours’ duration from Charlotte have afforded rejuvenation and a reset from all of the issues swirling around us. As I write this editorial, I am once again in the cool, crisp air of western North Carolina. I am in Cashiers.

Cashiers, known for its beauty and solitude, is the home of the High Hampton Resort. This pristine land also conjures up an important epoch in our surgical history, for in the late 19th and early 20th century, this was the property and home of Caroline Hampton and her husband, Dr. William Halsted. The imprint of the Halsteds, even now, continues to enhance this property. There is the Halsted Lodge, the magnificent Champion Trees (those deemed largest and best of their variety) that were planted by the Halsteds 100 years ago, and the lake where the Halsteds fished for trout.

The Cashiers Valley lies in a triangle bordered by Tennessee, South Carolina and Georgia. The elevation of 3,600 feet

creates, at this time of year, sunny days and cool nights with more than 80 inches of annual rainfall, making for a wonderful respite from the summer heat of Baltimore where the Halsteds resided.

After marrying in Columbia, S.C., on June 4, 1890—Dr. William Welch,

for his hunting or fishing acumen, he immediately fell in love with this beautiful place and extended their honeymoon in Cashiers by several months! The old hunting lodge would become a traditional destination in their lives. In 1895, Halsted arranged to purchase the Hampton family lodge and the remaining 450 acres from Caroline’s aunts. In the years

Cashiers, known for its beauty and solitude, is the home of the High Hampton Resort. This pristine land also conjures up an important epoch in our surgical history.

a colleague, served as Halsted’s best man—the couple left for their honeymoon trip to the Hampton family lodge in the Cashiers Valley of the Blue Ridge Mountains. The newly married couple went by rail to Lake Toxaway and then traveled the final 20 miles by wagon to High Hampton. Caroline had spent much of her youth roaming this beautiful estate. While Halsted was not known

Surgeons’ Lounge continued from page 15

is uncomplicated should be able to seal that anastomosis in a few days, just as with any GI tract anastomosis.

An esophageal leak, however, is potentially catastrophic, so I am conservative and withhold feeding until at least postoperative day 5 or 6, and I frequently obtain a watersoluble contrast study prior to initiation of feeding.

Because I place a jejunal feeding tube in all the patients, there is no rush to feed the patient, and one can wait to ensure a healed anastomosis before having to feed orally.

Many patients do not take in much initially due to lack of appetite, nausea from pain medications or inanition from surgery. The jejunal feeding tube allows not losing ground nutritionally and can shorten the hospital stay.

Other complications include pneumonia, poor gastric emptying, infection, deep vein thrombosis and chyle leak. Most of the time, I ligate the thoracic duct on purpose to try to avoid a chyle leak. When you haven’t identified it is when you regret it.

Chyle fistula is noted with an increase in drainage from the chest tube. Because the patient has not been eating in the early postoperative period, it does not look

that followed, Halsted annexed contiguous lands and small farms until the estate grew to more than 2,000 acres.

Although Halsted was not an experienced horseman, he enjoyed telling a story involving a ride through their High Hampton property. While riding, Caroline stopped her horse, turned to William and said, “William, there is a rattlesnake.

Get down and kill it.” Halsted related,

chylous or milky, but instead is fairly serous in appearance. It is the volume that should make one suspicious.

Measuring for chylomicrons and triglycerides can help make the diagnosis, but these levels may not always be high in the early postoperative period.

Chyle fistula is managed by chest tube drainage and IV octreotide, total parenteral nutrition and bowel rest.

There are some interventional radiologists who can access a lymph node in the groin, inject a contrast agent, and obtain lymphangiography identifying the exact location of the leak to facilitate surgical ligation, if indicated. They can even embolize the thoracic duct at the site of leakage, which may avoid need for surgical intervention. In my experience, if you’re willing to wait it out, most of them will close, but it is important to replace the volume loss, watch for infection and provide ongoing nutritional support. Reoperation to achieve thoracic duct ligation should be chosen if the fistula drainage is large after several days or if there are nutritional consequences. This will avoid the cost of a considerably prolonged hospital stay.

The surgical management of esophageal carcinoma and perforation is challenging and continues to evolve. It has been fulfilling to have been in this field.

The future will be in better screening for the disease for

“There I was alone in the mountains with this comparatively strange woman, and she wanted me to get off my horse and kill a rattlesnake. She was terribly disgusted when I refused” (quoted in “Genius on the Edge,” by Gerald Imber, MD).

This place, both Cashiers and High Hampton and the surrounding properties, is important in our surgical heritage.

The view of the mountains is dramatic, and, no doubt, the Halsteds spent many hours enjoying the granite peaks and waterfalls of Whiteside and Chimney Top mountains. For Halsted, High Hampton was a place to read, relax and indulge in activities he had little time for in Baltimore. Throughout their married life, Caroline would arrive in High Hampton in early spring and depart in November. Halsted was away from Baltimore and Johns Hopkins from May to October each year, spending usually two months at High Hampton. During that time, both Caroline and William would tend to Halsted’s prized dahlia garden that ended its growing season with the first frost each year.

William Stewart Halsted died on Sept. 7, 1922. In that same year, the High Hampton Inn in Cashiers opened for its first guests. Throughout the past 100 years, thousands have walked the hallowed grounds of High Hampton, but only a relative few have realized the true significance of this location in surgical lore. What a privilege it has been to visit this very special place. I urge you to do ■ the same.

—Dr. Greene is a surgeon in Charlotte, N.C.

earlier diagnosis when less invasive treatments can be successfully used, and in research to identify risk factors and molecular targets for early diagnosis and therapy. ■

References 1. Statistics for esophageal cancer. Accessed January 5, 2021. www.cancer.org/cancer/esophagus-cancer/about/ key-statistics.html 2. Napier KJ, Scheerer M, Misra S. Esophageal cancer: a review of epidemiology, pathogenesis, staging workup and treatment modalities. World J Gastrointest Oncol.

2014;6(5):112-120.

3. Cleveland Clinic esophageal cancer. Virtual medical school. Accessed January 5, 2021. www.teachmemedicine. org/cleveland-clinic-esophageal-cancer 4. Esophageal cancer: statistics. Cancer.net. Published June 25, 2012. Accessed January 5, 2021. www.cancer.net/ cancer-types/esophageal-cancer/statistics 5. Lambright E. Management of esophageal perforation. In: Current Surgical Therapy. 13th ed. Elsevier; 2020:78-80.

6. Freeman RK, Van Woerkom JM, Vyverberg A, et al. Esophageal stent placement for the treatment of spontaneous esophageal perforations. Ann Thorac Surg.

2009;88(1):194-198.

THE GREAT DEBATES

JUNE 2021 / GENERAL SURGERY NEWS

A Response to ‘Guidelines for Avoiding Bile Duct Injury: Beware’ continued from page 1

prevention of bile duct injuries (BDIs) during cholecystectomy (Ann Surg 2020;272[1]:3-23; co-publication Surg Endosc 2020;34[7]:2827-2855), the purpose of which was to address the infrequent but ongoing problem of BDI in this common procedure, and decries their use. We respond both in general and to some of the specific points he makes.

First, the main purpose of a clinical practice guideline is to use the best available evidence to formulate recommendations based on that evidence, and to provide practitioners with suggested and recommended strategies they can use to enhance clinical care and improve patient outcomes. A secondary, but very important, purpose is to determine the shortcomings in current knowledge and develop recommendations for further studies that can fill in the gaps in our knowledge. Key steps in creating a guideline are reviewing a vast amount of literature, rating the quality of the evidence in that literature, and making recommendations largely based on the quality of that evidence.

Dr. Voeller states “an individual surgeon’s algorithm in this challenging setting [when anatomic clarity is not achievable] should be consistent and based on their expertise.” But expertise is not simply based on an individual surgeon’s personal experience in surgery. It is also based on the literature, and guidelines have become a very important, high-level summary of the literature.

Guidelines are not, as suggested by Dr. Voeller, “mandated” or required, nor are they in any way “enforced.” The consensus guideline on prevention of BDI during cholecystectomy was a multisociety effort—including the Society of American Gastrointestinal and Endoscopic Surgeons, the Americas Hepato-Pancreato-Biliary Association, the International Hepato-Pancreato Biliary Association, the Society for Surgery of the Alimentary Tract, and the European Association of Endoscopic Surgery—and involved a rigorous and transparent methodological process, taking more than 2.5 years, to address key questions on this topic and provide the best recommendations possible given the evidence. It involved numerous diverse stakeholders including both high-volume academic and community surgeons who perform cholecystectomy and surgeons who are expert in repairing BDIs. The consensus meeting also involved an expert panel of 25 highly experienced surgeons who were not involved in developing the guideline recommendations, but were asked to comment and critique them. A high bar was set for approving a recommendation (80% agreement by the expert panelists).

Five of the 18 guideline questions did not have recommendations due to a lack of evidence. It is true that most of the recommendations that were made were derived from studies with low or very low quality of evidence, which reflects the quality of studies in the surgical literature and the rigor with which the GRADE methodology for forming a guideline assesses quality, rather than an invalidation of putting forth guideline recommendations. And it should be noted that

low quality of evidence does not mean the “absence” of evidence. In developing the recommendations, considerations of not only the evidence but also feasibility and acceptability by surgeons were substantially taken into account.

Any guideline should have a dissemination plan, which in this case has primarily involved publicizing this guideline through the sponsoring societies to their members, peer-reviewed publications and panel sessions at national meetings,

and has not to date involved hospitals, insurers and other groups. The recommendations were also carefully worded with regard to any potential medicolegal implications for surgeons.

Here we address some of the specific guideline recommendations commented on by Dr. Voeller.

1. Use of the critical view of safety (CVS). Dr. Voeller comments on a lack continued on the following page

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THE GREAT DEBATES

Bile Duct continued from the previous page

of high-quality evidence about the recommendation that the CVS be used as the primary method of ductal identification. A prospective, randomized trial to address this issue is not feasible because of the very large number of patients (20,000 or more) who would be needed to detect a significant difference, given the low rate of BDI. However, it is based on considerable case series evidence as well as the fact that in studies that look at videos of BDIs, the CVS method was never used. We have also personally seen multiple videos of lap chole cases in which a BDI occurred and have never seen the CVS obtained in any of those.

The CVS is also based on the proven method of safe ductal identification from the era of open cholecystectomy (Ann Surg 2017;265[3]:464-465), and difficulty in achieving it should alert the surgeon to a potentially dangerous situation in which the approach may need to be altered. From a medicolegal standpoint, surgeon use of the CVS should be protective and should lower the potential for putting him or her in jeopardy. Also, as Dr. Voeller serves as a defense expert, he should be aware of the prior perspective published in the Journal of the American College of Surgeons that addresses some of his concern (2010;211[1]:132-137).

2. Top–down approach versus subtotal cholecystectomy. Dr. Voeller states he has used the top–down approach in “impossibly diseased gallbladders” thousands of times. It would be helpful if he could explain how he manages to avoid any injuries in such cases, since the “impossibly diseased” language he uses implies a hostile hepatocystic triangle that cannot be safely dissected. Certainly, there are situations in which the top– down approach can be useful, and the recommendation does not abrogate that.

However, the rare but deadly “extreme vascular biliary injury” seems to occur when a shrunken gallbladder is dissected in a top–down fashion, where it can be difficult if not impossible to ascertain when the dissection from above is approaching the bile duct, portal vein and hepatic artery, which are drawn into the zone of severe inflammation (HPB [Oxford] 2012;14[1]:1-8) To wit, a “very memorable gallbladder” case was recently posted on ACS communities in which a dome–down approach in a very difficult inflamed gallbladder resulted in a common BDI. And what about surgeons in the early part of their career who don’t have a vast experience? Is it not safer to utilize subtotal cholecystectomy, which, if properly done, should have a low rate of serious complications and reoperation, or risk a severe injury?

GENERAL SURGERY NEWS / JUNE 2021

re In a study of more ic than 8,000 laparoscopic cholecystectomies from 166 hospitals in the United Kingdom, 779 patients had grade 4 inflammation, which is described as “cystic ped-icle—impossible to clar-ify” (note the similar usee ”) of the word “impossible”) 110(Surg Endosc 2019;33[1]:110121). Thirteen patientss in that group had major BDIs %, which for an injury rate of 1.7%, igher than the is more than five times higher

LLike ike it or not, we live in an era of evidence-based medicine. Out in the real world, surgeons need guidelines. They don’t need dictums or mandates, but they do need guidelines.

overall BDI rate for laparoscopic cholecystectomy, and this represents the best data from a Western country on the current status of BDI when there is severe inflammation. That is a key reason why more general surgery residents are being taught how to do the much safer operation of subtotal fenestrating cholecystectomy in the selected subset of patients with severe adverse conditions.

3. Use of IOC (or other imaging) to reduce the risk for BDI—the topic of the original debate between Drs. Brunt, Taylor Riall and Raul Rosenthal.

For complex hernia repair

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THE GREAT DEBATES

JUNE 2021 / GENERAL SURGERY NEWS

Dr. Voeller implies that because of the guideline recommendation, this means that surgeons who do not perform IOC are “violating the standard of care.” This is an inflammatory, misleading and erroneous statement. First, the guideline recommendation around IOC has two aspects: 1) to suggest its use in acute cholecystitis or a history of acute cholecystitis, based on substantial, albeit low-quality, national database studies; and 2) a strong recommendation to use IOC in cases of intraoperative uncertainty of anatomy or suspected biliary injury to mitigate the risk for BDI.

The latter can result in intraoperative recognition and avoidance of a higher level of injury in which a portion of the bile duct is excised. No recommendation was made in elective non-acute cholecystectomy due to the absence of evidence. Dr. Voeller also omits from his critique the concluding statements from Dr. Brunt in the aforementioned General Surgery News debate article, which states that he would not—nor would we—presume to take the position that all surgeons should perform IOC routinely (nor do the guidelines state this): “However, to perform IOC rarely or not at all

or not in a significant percentage of one’s cases is a missed opportunity to identify unsuspected pathology, potentially reduce biliary injury, provide training for residents, and maintain an important skill set.”

Finally, Dr. Voeller states that “it is time to reel in the guideline madness for the benefit of all concerned.” His personal series of 5,000 cases without a BDI is remarkable and undoubtedly reflects his experience and considerable skill as a surgeon, and perhaps some good fortune, but it is irrelevant to the issue of BDI and the surgical community at large.

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.

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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.

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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

In addition, in his criticisms he offers no constructive suggestions whatsoever for how to reduce the estimated 2,500 to 3,000 major BDIs that occur in the United Sates annually. In fact, he seems to take the nihilistic view that BDIs will occur and nothing can be done to prevent them—a position we could not disagree with more vigorously. He also almost completely ignores the most important constituent here: the patients. Many of the patients who suffer a BDI are young and more often women than men. The “real-world” impact for the patient can be devastating and diminish their quality of life long term, adversely affect their personal finances, and can even result in liver transplantation or death. And those of us who have experienced a BDI in our careers know all too well how it adversely affects us as surgeons as well.

Like it or not, we live in an era of evidence-based medicine. Out in the real world, surgeons need guidelines.

They don’t need dictums or mandates, but they do need guidelines. They need something upon which they can lean when they tell a patient or family member or referring physicians why they did not complete the cholecystectomy or left a drain tube. Summaries of evidence and guideline recommendations are also not rigid and are never meant to supplant surgeon judgment in a given case, which any astute reader of these guidelines should recognize. However, if we, as a profession, collectively do not do something to try and move the needle on BDI during cholecystectomy in the right direction, then shame on us. Perhaps it is worth remembering the words of George Santayana: “Those who do not remember the past are condemned to repeat it.”

Respectfully submitted, L. Michael Brunt, MD Washington University School of Medicine in St. Louis Steven M. Strasberg, MD Washington University School of Medicine in St. Louis Dana A. Telem, MD, MPH University of Michigan, Ann Arbor Daniel Deziel, MD Rush University Medical Center, Chicago Marian McDonald, MD St. Luke’s University Health Network, Allentown, Pa. Dimitrios Stefanidis, MD, PhD Indiana University School of Medicine, Indianapolis Taylor Riall, MD, PhD University of Arizona School of Medicine, Tucson

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IN THE NEWS

GENERAL SURGERY NEWS / JUNE 2021

Eliminating 24-Hour Call: Does It Work? continued from page 1

But her new position at Texas Tech University Health Sciences Center, in Lubbock, would be different from any previous experience in a major way: Her schedule contained no 24-hour calls.

“Before coming to Texas Tech, doing 24-hour shifts was always what I’d known,” said Dr. Richmond, an assistant professor of surgery. “By the time I’d get home after a full day going nonstop, I’d crash.”

For acute care surgeons, a standard schedule often includes an average of seven days of 24-hour in-house call every month. These 24 hours can easily morph into 30 or more, as surgeons finish their cases, manage handoffs and file lingering paperwork.

At Texas Tech, working a maximum of 12 hours at a stretch has been a game changer for Dr. Richmond.

“I’m no longer so bone-tired,” she said. “When I’m in the hospital for 12 hours, I’m all in. It doesn’t matter what I walk into; I have the mental and physical energy to give 100% on every shift.”

Physicians have long debated the impact of work-hour duration on patient safety and provider well-being, but few institutions have made the leap and deviated from the traditional 24-hour trauma call model.

“To make this happen, you need surgeon leadership at the helm,” said Steven Brooks, MD, the trauma medical director at Texas Tech. “That surgeon will first have to overcome the historical and cultural precedent and invest a lot of time and energy in reshaping how the department works.”

Overcoming this precedent has not been a simple task. The controversy over work-hour duration continues, in part because the evidence to date has failed to clarify the impact of shift duration on surgeon outcomes and wellness.

Take two analyses published last year. A New England Journal of Medicine study found that resident physicians randomly assigned to schedules with no 24-hour shifts made more serious errors than those who worked extended shifts (2020;382[26]:2514-2523). In contrast, a study in JAMA Network Open, analyzing survey data from more than 11,000 physicians, reported that sleep disruption significantly increased self-reports of burnout and medical errors that could cause patient harm (2020;3:e2028111).

Yet other research found minimal to no effect of shift duration on physician performance or wellness. On the performance front, a 2009 study exploring outcomes in 14 million Medicare patients and veterans revealed that the workhour restrictions imposed in 2003 had no discernable impact on patient safety

(Med Care 2009;47[7]:723-731). On the wellness front, a 2016 analysis concluded that surgical residents assigned to flexible duty hours did not report significantly greater dissatisfaction with the quality of their education or well-being (N Engl J Med 2016;374:713-727).

Despite the inconsistent evidence, Sharmila Dissanaike, MD, saw a way to parse through the noise.

“Overall, I do not think surgeons on 24-hour call are hurting patients, but I do think surgeons compensate for their exhaustion and hurt themselves so their patients don’t pay the price,” said Dr. Dissanaike, the Peter C. Canizaro Chair and Professor in the Department of Surgery at Texas Tech.

Watching her department grow busier and busier each year, Dr. Dissanaike knew that the default of adding 24-hour call to a full-time position was simply unsustainable. Meeting Dr. Richmond gave Dr. Dissanaike an opportunity to make a bold change, one she had been contemplating since becoming the department chair.

Piloting a New Model In 2017, while wrapping up a critical care fellowship in Dallas, Dr. Richmond began the job hunt. But she faced a complication: Her husband’s work took him to Mexico City, more than 1,000 miles away.

Dr. Richmond came up with a rather unorthodox plan to keep the family unit—her husband and five children— together: Crunch a month’s worth of trauma shifts into two weeks. That schedule would free her up to fly to Mexico City for the remaining two weeks of the month.

Most potential future employers rejected the idea right off the bat, Dr. Richmond recalled.

But Dr. Dissanaike was different. She sat in silence for a moment, considering the logistics, and said: “Yes, that will work.”

Dr. Dissanaike’s vision of how to restructure the trauma department began to take shape. Two surgeons would trade 12-hour shifts over 14 consecutive days.

Starting in September 2017, Dr. Richmond covered day shifts for half the month, and Catherine Ronaghan, MD, FACS, a professor and the vice chair of the Department of Surgery, agreed to take nights. Neither surgeon had a 24-hour call slot on her schedule.

“This change was revelatory,” Dr. Ronaghan said. “I noticed a difference immediately in my focus and energy, which allowed me to have much more meaningful experiences with patients.”

The system worked so well with two

surgeons that, in September 2018, the entire acute care surgery team switched to a 12-hour shift model.

But converting the acute care surgery service did not happen overnight.

The change required months of planning before and trial and error to work out the kinks after.

Initially, the team was short-staffed and struggled, Dr. Dissanaike said. To make the 12-hour schedule feasible at Texas Tech, Dr. Dissanaike realized she needed the equivalent of six full-time

the change meant more time with her family.

“On 24-hour calls, I missed countless meals, bedtimes and bath times,” said Dr. Puckett, a former resident who will be starting as a surgical oncologist at West Virginia University, Charleston, in the fall. “Once the shift to [the] 12-hour model occurred, I could be present most evenings to spend time with my family, which was very important to me. As a result, my quality of life during residency improved.”

‘If your concentration is impaired, should you really be doing surgery or even driving a car after a 24-hour shift?’

—Robyn Richmond, MD

acute care surgeons. The final plan configured a clinical full-time equivalent of 15, 12-hour shifts per month, or 18 days combining 12-hour shifts and regular workdays for rounding and covering the OR. This organization allowed every surgeon some protected time for education, research and rest.

Removing trauma call and subsequently trauma call pay meant Dr. Dissanaike needed to recalibrate the team’s base salaries. She did so by approximating the Association of American Medical Colleges median compensation figures for general surgery, and the money previously allocated for trauma call went to support the salaries of the acute care surgery team.

The “devil is in those details, but when we had everything in place, the transition to 12 hours went fairly quickly and smoothly,” Dr. Brooks recalled.

The new schedule has enabled Dr. Brooks to focus more on his well-being.

He has time to exercise in his home gym, eat regular meals, and get six to eight hours of sleep every day.

“I always imagined the brutal 24-hour call schedule was the cost of doing the job I love,” he said. “But now I’m feeling better physically and mentally, which has made me better for my patients and my colleagues.”

For Yana Puckett, MD, MBA, MPH,

The Evidence in Favor Piloting 12-hour shifts with Drs. Richmond and Ronaghan alongside the standard 24-hour call schedule provided a rare opportunity to study and compare these models within a single institution.

One of the burning questions the team wanted to answer: How long can surgeons maintain focus during a shift?

An analysis, presented in February 2019 and published in the Journal of Surgical Education late last year (2020 Dec 29), attempted to pinpoint a time frame when surgeons’ focus begins to fade). In the prospective study, 21 surgeons underwent a total of 61 eye-tracking tests—typically used to identify concussion in athletes—to measure visual attention before and after 12 and 24 hours on the job.

The team, led by Dr. Puckett, found almost no overall change in focus before and after a 12-hour shift, regardless of the time of day. But, after 24 hours, focus scores dropped significantly—by almost half—indicating fatigue started to set in sometime between 12 and 24 hours.

“The results were stunning,” said Dr. Ronaghan, lead author of the study. “We saw that surgeons basically started to lose focus sometime after working 12 hours.”

The findings made the Texas Tech team question what this focus deficit might mean for patient care. “If your concentration is impaired, should you really be

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JUNE 2021 / GENERAL SURGERY NEWS

doing surgery or even driving a car after a 24-hour shift?” Dr. Richmond noted.

In other words, does shift duration affect patient outcomes and safety?

The Texas Tech team got to work investigating, using the hybrid period of 12- and 24-hour shift schedules to compare outcomes of the most common elective surgical procedures.

In October 2019, the surgeons presented data from a retrospective review of patients undergoing laparoscopic appendectomy for acute appendicitis between September 2017 and June 2018. Although they found patient outcomes were similar overall, the 12-hour model was associated with several benefits: shorter hospital stay (0.6 vs. 2.4 days), reduced wait times to surgery (4.7 vs. 5.8) and fewer organ space infections (none vs. 7.1%). Perhaps the most notable finding was that costs per patient were significantly lower in the 12-hour model: $2,183 versus $5,866.

To understand whether these results extended beyond appendectomy, the team conducted a similar review for laparoscopic cholecystectomy. The retrospective analysis, presented at the September 2020 virtual Southwestern Surgical Congress, examined outcomes in the 12-hour and traditional shift groups. Again, the surgeons found similar patient outcomes in both scenarios, but significantly shorter hospital stays and lower costs in the 12-hour group.

“The data we produced on appendectomy, cholecystectomy and focus by comparing the two groups head-to-head contemporaneously also helped convince us we were on the right track,” Dr. Dissanaike said.

No One-Size-Fits-All Solution The evidence from Texas Tech makes a strong case for abandoning 24-hour call.

Shorter shifts leave surgeons more alert at work and reduce the time and costs associated with two common operations.

“As surgeons, we’re so used to the pain of these long shifts, but over time it becomes harder and harder to recover,” said Peter Kim, MD, a general surgeon at Albert Einstein College of Medicine and Jacobi Medical Center, in New York City, and co-author of the 2020 sleep-burnout study in JAMA (2020;3:e2028111). “I’m trying to limit the 24-hours calls I do, and I’ve made some progress. But I think it’s part of the culture at most institutions.”

Dr. Kim sees unpredictable, grueling schedules helping to fuel the physician burnout problem. “If we can improve surgeons’ sleep patterns from a structural standpoint, I believe we will also improve physician wellness and reduce burnout,” he said.

Still, completely eliminating 24-hour call is not necessarily feasible or the right move for every surgeon or department.

Shifting to a 12-hour model means more complex scheduling and salary logistics, such as hiring more physicians to cover trauma, critical care or emergency general surgery services 24 hours a day.

“I am not proposing this model for everyone, especially low-volume services,” Dr. Dissanaike said, clarifying that the 12-hour shift model likely only makes sense in high-volume acute care trauma centers, and possibly not in small community centers that only see a few patients nightly.

The success of the 12-hour model also depends heavily on the team itself.

“Your team has to be like a family,” said Nicole A. Stassen, MD, the director of the Kessler Family Burn & Trauma Intensive Care Unit and a professor of surgery at the University of Rochester, in New York. “Everyone needs to have confidence that each member has their back.”

Outside of historical precedent and team dynamics, some surgeons may simply prefer the 24-hour model. Instead of spreading 12-hour shifts over more weekdays and weekends, “I’ve heard surgeons argue that getting the pain over within a 24-hour call period is better,”

Dr. Richmond noted.

Still, Dr. Dissanaike hopes institutions see that a 12-hour model can be done, and perhaps down the line, can create a schedule better customized to meet surgeons’ needs and preferences.

“This 12-hour framework can only work if institutions show a critical mass of support,” Dr. Dissanaike said. “I am hugely grateful to have had a team willing to jump on board what may have felt like a crazy idea and stick with it through the tough times when we were figuring it out. The evolution was worth it given how well the system is working now.” ■

ADVANCING POSTSURGICAL PAIN MANAGEMENT AND RECOVERY Powered by DepoFoam® technology to deliver precise pain control for the critical first few days after surgery

MORE THAN

8 MILLION ADULT PATIENTS HAVE RECEIVED EXPAREL SINCE 2012 1

LEARN MORE AT WWW.EXPAREL.COM Indication EXPAREL® (bupivacaine liposome injectable suspension) is indicated for single-dose infiltration in patients aged 6 years and older to produce postsurgical local analgesia and in adults as an interscalene brachial plexus nerve block to produce postsurgical regional analgesia. Safety and efficacy have not been established in other nerve blocks.

routes of administration: epidural, intrathecal, regional nerve blocks other than interscalene brachial plexus nerve block, or intravascular or intra-articular use.

The potential sensory and/or motor loss with EXPAREL is temporary and varies in degree and duration depending on the site of injection and dosage administered and may last for up to 5 days, as seen in clinical trials.

Important Safety Information EXPAREL is contraindicated in obstetrical paracervical block anesthesia.

Adverse reactions reported in adults with an incidence greater than or equal to 10% following EXPAREL administration via infiltration were nausea, constipation, and vomiting; adverse reactions reported in adults with an incidence greater than or equal to 10% following EXPAREL administration via interscalene brachial plexus nerve block were nausea, pyrexia, and constipation.

Adverse reactions with an incidence greater than or equal to 10% following EXPAREL administration via infiltration in pediatric patients six to less than 17 years of age were nausea, vomiting, constipation, hypotension, anemia, muscle twitching, vision blurred, pruritis, and tachycardia.

If EXPAREL and other non-bupivacaine local anesthetics, including lidocaine, are administered at the same site, there may be an immediate release of bupivacaine from EXPAREL. Therefore, EXPAREL may be administered to the same site 20 minutes after injecting lidocaine.

EXPAREL is not recommended to be used in the following patient populations: patients <6 years old for infiltration, patients younger than 18 years old for interscalene brachial plexus nerve block, and/or pregnant patients.

Because amide-type local anesthetics, such as bupivacaine, are metabolized by the liver, EXPAREL should be used cautiously in patients with hepatic disease.

Warnings and Precautions for Bupivacaine-Containing Products Central Nervous System (CNS) Reactions: There have been reports of adverse neurologic reactions with the use of local anesthetics. These include persistent anesthesia and paresthesia. CNS reactions are characterized by excitation and/or depression.

Cardiovascular System Reactions: Toxic blood concentrations depress cardiac conductivity and excitability, which may lead to dysrhythmias, sometimes leading to death.

Allergic Reactions: Allergic-type reactions (eg, anaphylaxis and angioedema) are rare and may occur as a result of hypersensitivity to the local anesthetic or to other formulation ingredients.

Chondrolysis: There have been reports of chondrolysis (mostly in the shoulder joint) following intra-articular infusion of local anesthetics, which is an unapproved use.

Methemoglobinemia: Cases of methemoglobinemia have been reported with local anesthetic use.

Warnings and Precautions Specific to EXPAREL Avoid additional use of local anesthetics within 96 hours following administration of EXPAREL. EXPAREL is not recommended for the following types or ©2021 Pacira BioSciences, Inc. Parsippany, NJ 07054 PP-EX-US-6517 03/21

Please refer to brief summary of Prescribing Information on adjacent page.

For more information, please visit www.EXPAREL.com or call 1-855-793-9727.

Reference: 1. Data on File. 6450. Parsippany, NJ: Pacira BioSciences, Inc.; January 2021.

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GENERAL SURGERY NEWS / JUNE 2021

Learning to Land continued from page 13

In the same way that a flight instructor ensures his student gets closer and closer to an autonomous pilot, he also ensures the plane gets back safely on the ground every single time. The roles aren’t antagonistic; they’re inherent, complementary, necessary parts of the same process. Ignoring one at the expense of the other almost uniformly results in disaster.

But acknowledging these processes also means I have an obligation to my

Brief Summary (For full prescribing information refer to package insert) INDICATIONS AND USAGE EXPAREL is indicated for single-dose infiltration in patients aged 6 years and older to produce postsurgical local analgesia and in adults as an interscalene brachial plexus nerve block to produce postsurgical regional analgesia.

Limitation of Use: Safety and efficacy has not been established in other nerve blocks.

CONTRAINDICATIONS EXPAREL is contraindicated in obstetrical paracervical block anesthesia.

While EXPAREL has not been tested with this technique, the use of bupivacaine HCl with this technique has resulted in fetal bradycardia and death.

WARNINGS AND PRECAUTIONS Warnings and Precautions Specific for EXPAREL As there is a potential risk of severe life-threatening adverse effects associated with the administration of bupivacaine, EXPAREL should be administered in a setting where trained personnel and equipment are available to promptly treat patients who show evidence of neurological or cardiac toxicity.

Caution should be taken to avoid accidental intravascular injection of EXPAREL. Convulsions and cardiac arrest have occurred following accidental intravascular injection of bupivacaine and other amidecontaining products.

Avoid additional use of local anesthetics within 96 hours following administration of EXPAREL. EXPAREL has not been evaluated for the following uses and, therefore, is not recommended for these types of analgesia or routes of administration.

• epidural • intrathecal • regional nerve blocks other than interscalene brachial plexus nerve block • intravascular or intra-articular use EXPAREL has not been evaluated for use in the following patient population and, therefore, it is not recommended for administration to these groups.

• patients younger than 6 years old for infiltration • patients younger than 18 years old for interscalene brachial plexus nerve block • pregnant patients The potential sensory and/or motor loss with EXPAREL is temporary and varies in degree and duration depending on the site of injection and dosage administered and may last for up to 5 days as seen in clinical trials.

ADVERSE REACTIONS Clinical Trial Experience Adverse Reactions Reported in Local Infiltration Clinical Studies The safety of EXPAREL was evaluated in 10 randomized, double-blind, local administration into the surgical site clinical studies involving 823 patients undergoing various surgical procedures. Patients were administered a dose ranging from 66 to 532 mg of EXPAREL. In these studies, the most common adverse reactions (incidence greater than or equal to 10%) following EXPAREL administration were nausea, constipation, and vomiting. The common adverse reactions (incidence greater than or equal to 2% to less than 10%) following EXPAREL administration were pyrexia, dizziness, edema peripheral, anemia, hypotension, pruritus, tachycardia, headache, insomnia, anemia postoperative, muscle spasms, hemorrhagic anemia, back pain, somnolence, and procedural pain.

Adverse Reactions Reported in All Local Infiltration Clinical Studies in Pediatric Patients Aged 6 to Less Than 17 Years The safety of EXPAREL in 110 pediatric patients between the age of 6 and 17 years old undergoing various surgical procedures was evaluated in one randomized, open-label, clinical study in which EXPAREL was administered by infiltration into the surgical site and one single-arm, open-label study in which EXPAREL was administered by infiltration into the surgical site. Patients were administered a weight-based dose of EXPAREL at 4 mg/kg (maximum dose of 266 mg) or bupivacaine HCl 2 mg/kg (maximum dose of 175 mg). In these studies, the most common adverse reactions (incidence greater than or equal to 10%) following EXPAREL administration were nausea, vomiting, constipation, hypotension, anemia, muscle twitching, vision blurred, pruritus, and tachycardia.

The common adverse reactions (incidence greater than or equal to 2% to less than 10%) following EXPAREL administration were bradycardia, muscle spasms, tachypnea, hypoesthesia oral, anemia postoperative, dizziness, pyrexia, diarrhea, hypoacusis, hypoesthesia, back pain, hematuria, incontinence, muscular weakness, and visual impairment.

Adverse Reactions Reported in Nerve Block Clinical Studies The safety of EXPAREL was evaluated in four randomized, double-blind, placebo-controlled nerve block clinical studies involving 469 patients undergoing various surgical procedures. Patients were administered a dose of either 133 or 266 mg of EXPAREL. In these studies, the most common adverse reactions (incidence greater than or equal to 10%) following EXPAREL administration were nausea, pyrexia, and constipation.

The common adverse reactions (incidence greater than or equal to 2% to less than 10%) following EXPAREL administration as a nerve block were muscle twitching, dysgeusia, urinary retention, fatigue, headache, confusional state, hypotension, hypertension, hypoesthesia oral, pruritus generalized, hyperhidrosis, tachycardia, sinus tachycardia, anxiety, fall, body temperature increased, edema peripheral, sensory loss, hepatic enzyme increased, hiccups, hypoxia, post-procedural hematoma.

trainee’s future patients, to step out of the cockpit, and watch as they fly the plane by themselves.

■ —Dr. Peetz is an assistant professor of surgery, and faculty, Center for Biomedical Ethics and Society, Vanderbilt University School of Medicine, Division of Trauma and Surgical Critical Care, in Nashville, Tenn.

‘Timely Topics in Surgery’ Series Editor: Ajita S. Prabhu, MD, associate professor of surgery, Cleveland Clinic Foundation, Ohio

Rectal Radiation continued from page 4

and live with a stoma or a diaper for the rest of your life, or you can spend a few dollars and go back to dignity and having fun.”

Dr. Paty said eradicating rectal cancer without surgery is the best solution to the problems being discussed and that watchand-wait with nonoperative management is where clinical trials should be pushing forward.

“The oncologic results, quality of life and cost savings of the watch-and-wait patients are the best of any group you can find among

Postmarketing Experience These adverse reactions are consistent with those observed in clinical studies and most commonly involve the following system organ classes (SOCs): Injury, Poisoning, and Procedural Complications (e.g., drug-drug interaction, procedural pain), Nervous System Disorders (e.g., palsy, seizure), General Disorders And Administration Site Conditions (e.g., lack of efficacy, pain), Skin and Subcutaneous Tissue Disorders (e.g., erythema, rash), and Cardiac Disorders (e.g., bradycardia, cardiac arrest).

DRUG INTERACTIONS The toxic effects of local anesthetics are additive and their coadministration should be used with caution including monitoring for neurologic and cardiovascular effects related to local anesthetic systemic toxicity. Avoid additional use of local anesthetics within 96 hours following administration of EXPAREL. Patients who are administered local anesthetics may be at increased risk of developing methemoglobinemia when concurrently exposed to the following drugs, which could include other local anesthetics: Examples of Drugs Associated with Methemoglobinemia:

Class Examples Nitrates/Nitrites nitric oxide, nitroglycerin, nitroprusside, nitrous oxide Local anesthetics articaine, benzocaine, bupivacaine, lidocaine, mepivacaine, prilocaine, procaine, ropivacaine, tetracaine Antineoplastic cyclophosphamide, flutamide, hydroxyurea, ifosfamide, agents rasburicase Antibiotics dapsone, nitrofurantoin, para-aminosalicylic acid, sulfonamides Antimalarials chloroquine, primaquine Anticonvulsants Phenobarbital, phenytoin, sodium valproate Other drugs acetaminophen, metoclopramide, quinine, sulfasalazine Bupivacaine Bupivacaine HCl administered together with EXPAREL may impact the pharmacokinetic and/or physicochemical properties of EXPAREL, and this effect is concentration dependent. Therefore, bupivacaine HCl and EXPAREL may be administered simultaneously in the same syringe, and bupivacaine HCl may be injected immediately before EXPAREL as long as the ratio of the milligram dose of bupivacaine HCl solution to EXPAREL does not exceed 1:2.

Non-bupivacaine Local Anesthetics EXPAREL should not be admixed with local anesthetics other than bupivacaine. Nonbupivacaine based local anesthetics, including lidocaine, may cause an immediate release of bupivacaine from EXPAREL if administered together locally. The administration of EXPAREL may follow the administration of lidocaine after a delay of 20 minutes or more. There are no data to support administration of other local anesthetics prior to administration of EXPAREL. Other than bupivacaine as noted above, EXPAREL should not be admixed with other drugs prior to administration.

Water and Hypotonic Agents Do not dilute EXPAREL with water or other hypotonic agents, as it will result in disruption of the liposomal particles USE IN SPECIFIC POPULATIONS Pregnancy Risk Summary There are no studies conducted with EXPAREL in pregnant women.

In animal reproduction studies, embryo-fetal deaths were observed with subcutaneous administration of bupivacaine to rabbits during organogenesis at a dose equivalent to 1.6 times the maximum recommended human dose (MRHD) of 266 mg. Subcutaneous administration of bupivacaine to rats from implantation through weaning produced decreased pup survival at a dose equivalent to 1.5 times the MRHD [see Data]. Based on animal data, advise pregnant women of the potential risks to a fetus.

The background risk of major birth defects and miscarriage for the indicated population is unknown. However, the background risk in the U.S. general population of major birth defects is 2-4% and of miscarriage is 15-20% of clinically recognized pregnancies.

Clinical Considerations Labor or Delivery Bupivacaine is contraindicated for obstetrical paracervical block anesthesia. While EXPAREL has not been studied with this technique, the use of bupivacaine for obstetrical paracervical block anesthesia has resulted in fetal bradycardia and death.

Bupivacaine can rapidly cross the placenta, and when used for epidural, caudal, or pudendal block anesthesia, can cause varying degrees of maternal, fetal, and neonatal toxicity. The incidence and degree of toxicity depend upon the procedure performed, the type, and amount of drug used, and the technique of drug administration. Adverse reactions in the parturient, fetus, and neonate involve alterations of the central nervous system, peripheral vascular tone, and cardiac function.

Data Animal Data Bupivacaine hydrochloride was administered subcutaneously to rats and rabbits during the period of organogenesis (implantation to closure of the hard plate). Rat doses were 4.4, 13.3, and 40 mg/kg/day (equivalent to 0.2, 0.5 and 1.5 times the MRHD, respectively, based on the BSA comparisons and a 60 kg human weight) and rabbit doses were 1.3, 5.8, and 22.2 mg/ kg/day (equivalent to 0.1, 0.4 and 1.6 times the MRHD, respectively, based on the BSA comparisons and a 60 kg human weight). No embryofetal effects were observed in rats at the doses tested with the high dose causing increased maternal lethality. An increase in embryo-fetal deaths was observed in rabbits at the high dose in the absence of maternal toxicity.

Decreased pup survival was noted at 1.5 times the MRHD in a rat pre- and post-natal development study when pregnant animals were administered subcutaneous doses of 4.4, 13.3, and 40 mg/kg/day buprenorphine hydrochloride (equivalent to 0.2, 0.5 and 1.5 times the MRHD, respectively, based on the BSA comparisons and a 60 kg human weight)

locally advanced rectal cancer patients,” Dr. Paty said. “There is no data for watchand-wait using short-course radiation, but given the data discussed in this talk, it is likely that fewer patients will achieve clinical CR [complete response], and functional outcomes will likely be worse. … Finally, I want to say that long-course radiation is inherently better because it employs standard fractionation, which widens the therapeutic window between tumor cells and normal stem cells. Long-course radiation is also a more flexible platform allowing anatomic targeting, use of radiosensitizers and adaptive therapy.”

■

from implantation through weaning (during pregnancy and lactation).

Lactation Risk Summary Limited published literature reports that bupivacaine and its metabolite, pipecoloxylidide, are present in human milk at low levels. There is no available information on effects of the drug in the breastfed infant or effects of the drug on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for EXPAREL and any potential adverse effects on the breastfed infant from EXPAREL or from the underlying maternal condition.

Pediatric Use The safety and effectiveness of EXPAREL for single-dose infiltration to produce postsurgical local anesthesia have been established in pediatric patients aged 6 years and older. Use of EXPAREL for this indication is supported by evidence from adequate and well-controlled studies in adults with additional pharmacokinetic and safety data in pediatric patients aged 6 years and older.

Safety and effectiveness have not been established in pediatric patients aged less than 6 years old for local infiltration or less than 18 years old for interscalene brachial plexus nerve block.

Geriatric Use Of the total number of patients in the EXPAREL local infiltration clinical studies (N=823), 171 patients were greater than or equal to 65 years of age and 47 patients were greater than or equal to 75 years of age. Of the total number of patients in the EXPAREL nerve block clinical studies (N=531), 241 patients were greater than or equal to 65 years of age and 60 patients were greater than or equal to 75 years of age. No overall differences in safety or effectiveness were observed between these patients and younger patients. Clinical experience with EXPAREL has not identified differences in efficacy or safety between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

Hepatic Impairment Amide-type local anesthetics, such as bupivacaine, are metabolized by the liver. Patients with severe hepatic disease, because of their inability to metabolize local anesthetics normally, are at a greater risk of developing toxic plasma concentrations, and potentially local anesthetic systemic toxicity. Therefore, consider increased monitoring for local anesthetic systemic toxicity in subjects with moderate to severe hepatic disease.

Renal Impairment Bupivacaine is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. This should be considered when performing dose selection of EXPAREL. OVERDOSAGE Clinical Presentation Acute emergencies from local anesthetics are generally related to high plasma concentrations encountered during therapeutic use of local anesthetics or to unintended intravascular injection of local anesthetic solution.

Signs and symptoms of overdose include CNS symptoms (perioral paresthesia, dizziness, dysarthria, confusion, mental obtundation, sensory and visual disturbances and eventually convulsions) and cardiovascular effects (that range from hypertension and tachycardia to myocardial depression, hypotension, bradycardia and asystole).

Plasma levels of bupivacaine associated with toxicity can vary. Although concentrations of 2,500 to 4,000 ng/mL have been reported to elicit early subjective CNS symptoms of bupivacaine toxicity, symptoms of toxicity have been reported at levels as low as 800 ng/mL. Management of Local Anesthetic Overdose At the first sign of change, oxygen should be administered.

The first step in the management of convulsions, as well as underventilation or apnea, consists of immediate attention to the maintenance of a patent airway and assisted or controlled ventilation with oxygen and a delivery system capable of permitting immediate positive airway pressure by mask. Immediately after the institution of these ventilatory measures, the adequacy of the circulation should be evaluated, keeping in mind that drugs used to treat convulsions sometimes depress the circulation when administered intravenously. Should convulsions persist despite adequate respiratory support, and if the status of the circulation permits, small increments of an ultra-short acting barbiturate (such as thiopental or thiamylal) or a benzodiazepine (such as diazepam) may be administered intravenously. The clinician should be familiar, prior to the use of anesthetics, with these anticonvulsant drugs. Supportive treatment of circulatory depression may require administration of intravenous fluids and, when appropriate, a vasopressor dictated by the clinical situation (such as ephedrine to enhance myocardial contractile force).

If not treated immediately, both convulsions and cardiovascular depression can result in hypoxia, acidosis, bradycardia, arrhythmias and cardiac arrest. If cardiac arrest should occur, standard cardiopulmonary resuscitative measures should be instituted.

Endotracheal intubation, employing drugs and techniques familiar to the clinician, maybe indicated, after initial administration of oxygen by mask, if difficulty is encountered in the maintenance of a patent airway or if prolonged ventilatory support (assisted or controlled) is indicated.

DOSAGE AND ADMINISTRATION Important Dosage and Administration Information • EXPAREL is intended for single-dose administration only.

• Different formulations of bupivacaine are not bioequivalent even if the milligram strength is the same. Therefore, it is not possible to convert dosing from any other formulations of bupivacaine to EXPAREL. • DO NOT dilute EXPAREL with water or other hypotonic agents, as it will result in disruption of the liposomal particles.

• Use suspensions of EXPAREL diluted with preservative-free normal (0.9%) saline for injection or lactated Ringer’s solution within 4 hours of preparation in a syringe.

• Do not administer EXPAREL if it is suspected that the vial has been frozen or exposed to high temperature (greater than 40°C or 104°F) for an extended period.

• Inspect EXPAREL visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not administer EXPAREL if the product is discolored.

Recommended Dosing Local Analgesia via Infiltration Dosing in Adults The recommended dose of EXPAREL for local infiltration in adults is up to a maximum dose of 266mg (20 mL), and is based on the following factors: • Size of the surgical site • Volume required to cover the area • Individual patient factors that may impact the safety of an amide local anesthetic As general guidance in selecting the proper dosing, two examples of infiltration dosing are provided: • In patients undergoing bunionectomy, a total of 106 mg (8 mL) of EXPAREL was administered with 7 mL infiltrated into the tissues surrounding the osteotomy, and 1 mL infiltrated into the subcutaneous tissue.

• In patients undergoing hemorrhoidectomy, a total of 266 mg (20 mL ) of EXPAREL was diluted with 10 mL of saline, for a total of 30 mL, divided into six 5 mL aliquots, injected by visualizing the anal sphincter as a clock face and slowly infiltrating one aliquot to each of the even numbers to produce a field block.

Local Analgesia via Infiltration Dosing in Pediatric Patients The recommended dose of EXPAREL for single-dose infiltration in pediatric patients, aged 6 to less than 17 years, is 4 mg/kg (up to a maximum of 266 mg), and is based upon two studies of pediatric patients undergoing either spine surgery or cardiac surgery.

Regional Analgesia via Interscalene Brachial Plexus Nerve Block Dosing in Adults The recommended dose of EXPAREL for interscalene brachial plexus nerve block in adults is 133 mg (10 mL), and is based upon one study of patients undergoing either total shoulder arthroplasty or rotator cuff repair.

Compatibility Considerations Admixing EXPAREL with drugs other than bupivacaine HCl prior to administration is not recommended.

• Non-bupivacaine based local anesthetics, including lidocaine, may cause an immediate release of bupivacaine from EXPAREL if administered together locally. The administration of EXPAREL may follow the administration of lidocaine after a delay of 20 minutes or more.

• Bupivacaine HCl administered together with EXPAREL may impact the pharmacokinetic and/or physicochemical properties of EXPAREL, and this effect is concentration dependent. Therefore, bupivacaine HCl and EXPAREL may be administered simultaneously in the same syringe, and bupivacaine HCl may be injected immediately before EXPAREL as long as the ratio of the milligram dose of bupivacaine HCl solution to EXPAREL does not exceed 1:2.

The toxic effects of these drugs are additive and their administration should be used with caution including monitoring for neurologic and cardiovascular effects related to local anesthetic systemic toxicity.

• When a topical antiseptic such as povidone iodine (e.g., Betadine®) is applied, the site should be allowed to dry before EXPAREL is administered into the surgical site. EXPAREL should not be allowed to come into contact with antiseptics such as povidone iodine in solution.

Studies conducted with EXPAREL demonstrated that the most common implantable materials (polypropylene, PTFE, silicone, stainless steel, and titanium) are not affected by the presence of EXPAREL any more than they are by saline. None of the materials studied had an adverse effect on EXPAREL. Non-Interchangeability with Other Formulations of Bupivacaine Different formulations of bupivacaine are not bioequivalent even if the milligram dosage is the same. Therefore, it is not possible to convert dosing from any other formulations of bupivacaine to EXPAREL and vice versa.

Liposomal encapsulation or incorporation in a lipid complex can substantially affect a drug’s functional properties relative to those of the unencapsulated or nonlipid-associated drug. In addition, different liposomal or lipid-complexed products with a common active ingredient may vary from one another in the chemical composition and physical form of the lipid component. Such differences may affect functional properties of these drug products. Do not substitute.

CLINICAL PHARMACOLOGY Pharmacokinetics Administration of EXPAREL results in significant systemic plasma levels of bupivacaine which can persist for 96 hours after local infiltration and 120 hours after interscalene brachial plexus nerve block. In general, peripheral nerve blocks have shown systemic plasma levels of bupivacaine for extended duration when compared to local infiltration.

Systemic plasma levels of bupivacaine following administration of EXPAREL are not correlated with local efficacy.

PATIENT COUNSELING Inform patients that use of local anesthetics may cause methemoglobinemia, a serious condition that must be treated promptly.

Advise patients or caregivers to seek immediate medical attention if they or someone in their care experience the following signs or symptoms: pale, gray, or blue colored skin (cyanosis); headache; rapid heart rate; shortness of breath; lightheadedness; or fatigue.

Pacira Pharmaceuticals, Inc. San Diego, CA 92121 USA Patent Numbers: 6,132,766 5,891,467

5,766,627

8,182,835

Trademark of Pacira Pharmaceuticals, Inc. For additional information call 1-855-RX-EXPAREL (1-855-793-9727) Rx only

March 2021

IN THE NEWS

JUNE 2021 / GENERAL SURGERY NEWS

23

Surgical Infections, Most Complications Not Increased With Pre-op Biologics

By DAVID WILD

U

sing biologic agents before surgery does not increase the risk for postoperative complications in patients with inflammatory bowel disease, new research has shown.

Experts said the review of more than 1,500 patients, presented at the 2021 virtual Crohn’s and Colitis Congress (abstract 3494221), should reassure clinicians and patients that the prospect of surgery should not affect their decision to start or continue biologic treatment.

“This is a nicely designed database study that shows that regardless of where a surgery is performed, use of biologics in general does not increase the risk of adverse postoperative events,” said Joseph Feuerstein, MD, the associate clinical chief of gastroenterology at Beth Israel Deaconess Medical Center, and an associate professor of gastroenterology at Harvard Medical School, both in Boston. He was not involved in the research.

For the study, Stefan Holubar, MD, a staff surgeon at Cleveland Clinic, in Cleveland, and his colleagues examined data from 1,562 people with IBD who underwent surgery at one of 10 centers between 2017 and 2018. Patients were registered in the American College of Surgeons’ National Surgical Quality Improvement Program IBD Collaborative database and had 30 days of followup data postoperatively.

Roughly half of the patients had received biologics in the 60 days prior to surgery. Those who did were more likely to be underweight preoperatively, and to have lower albumin levels, higher rates of systemic sepsis, more use of immunomodulators and steroids, and were more likely to have Crohn’s disease. They also were more likely to have a colectomy and an ostomy during the surgery, and their operations were more likely to be emergent, according to the researchers.

Dr. Holubar reported that 13.3% and 12.7% of patients who did or did not receive a biologic, respectively, experienced a postoperative infection, and 23.8% and 23%, respectively, had any type of complication after surgery. Surgical site infections occurred in 11.1% and 10.2% of biologic users and biologic nonusers, respectively, he said. None of these differences was statistically significant, he said.

The only postoperative outcome that was significantly more common in biologic recipients was anastomotic leak after proctectomy (6.7% vs. 1.9%; P=0.02), a finding that Dr. Holubar said was “intriguing and hypothesis-generating.”

Multivariate analyses confirmed that

biologic use did not significantly increase the risk for infectious complications or surgical site infections. Crohn’s disease (odds ratio [OR], 2.11; 95% CI, 1.124.0; P=0.02) and proctectomy (OR, 3.15; 95% CI, 1.25-7.95; P=0.02) were the only variables associated with an increased risk for infectious complications, the analyses showed.

“Biologics are not associated with

postoperative infectious complications after surgery for IBD in this very large cohort, despite the fact they are a sicker group of patients,” Dr. Holubar said.

Dr. Holubar acknowledged several limitations of the study design, including a potential for selection bias, a short duration of follow-up and “relatively low numbers in subgroup analysis.

“We are, however, adding a third year

of data, as well as variables such as specific types of biologics and immunomodulators used, and a number of venous thromboembolism types,” Dr. Holubar said.

Dr. Feuerstein said he was looking forward to “granular, patient-specific data that we need to determine whether there are any differences in postoperative outcomes based on the specific biologic agent used, or the timing of the last dose prior to surgery.” ■

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OPINION

GENERAL SURGERY NEWS / JUNE 2021

Ants to Robotics: 10 Tools of Surgery continued from page 1

opposite sides of the wound edge; the ant instinctively clamps down and closes the wound; the ant’s head is snipped off; the closure stays in place until wound healing occurs. The first known written description of wound closure by the jaws of ants appears in the Atharvaveda (India), written in 1,000 b.c., and amazingly refers not to skin closure but to closure of intestines.

These ant-wound closures might be considered predecessors of surgical staplers.

Africans also used acacia thorns for wound closure, and several early civilizations sewed wounds with plant fibers threaded on bone slivers or plant needles.

The ancient Egyptians became highly skilled in sewing wounds with cotton thread, establishing one of the cardinal tasks of surgery: suturing.

Instrumentation Neolithic (10,000 b.c.) trephines were used for creating circular holes in the skull—possibly to let out evil spirits— a practice in use today in the treatment of epidural and subdural hematomas.

The first surgical knife dates back to the Mesolithic (8,000 b.c.) period. The term “scalpel” comes from Latin and was introduced by the surgeons of ancient Rome. The culture of ancient Egypt (3,500 b.c.) gave rise to a sophisticated and varied collection of surgical instruments, the originals or forerunners of essentially every tool used in today’s OR: knives, forceps, clamps, needles, thread, etc. These instruments are pictorially illustrated in tomb hieroglyphics. A tomb carving, dated to 3,000 to 2,400 b.c., in Memphis, Egypt, depicts an instrumentassisted circumcision procedure, a ritualistic operation in many world cultures.

Anesthesia The ability to initiate unconsciousness was used for public amusement by 1540.

Nitrous oxide, synthesized by Humphrey Davy in 1797, was employed to generate laughter in the British “Frolics.” It was only in 1845 when nitrous oxide was used for a dental extraction (Horace Wells), albeit unsuccessfully, before a critical audience at the Massachusetts General Hospital. One year later, this procedure was performed successfully by William Morton before the same critical audience. This was the beginning of anesthesia in health care.

Before anesthetics became common in operative practice, anesthesia, so to speak, consisted of finding four strong men to hold down the patient and placing a block of wood in the patient’s mouth to dull his or her screams, probably preceded by a liberal dose of alcoholic spirits. The introduction of anesthetics increased the number of operations performed astronomically,

particularly for elective surgery, heralding the onset of modern surgery.

Lighting Adequate lighting of the operative field is essential. Sailing ship surgeons would wait until the sun was high in the sky before attempting an operation on the ship’s deck. Even as late as the 1960s, operating in an outlying state hospital, I relied on daylight coming through a window for illumination.

Overhead, adjustable light fixtures were a masterful improvement and the primary light source during the open surgery era. At times, however, they fell short of what the surgeon wanted. The legendary surgeon, Owen H. Wangensteen, in addition to the multi-beam overhead light, in the 1930s to 1960s, had a surgical resident focus a naked light bulb tied to a broom handle on the area of concern; this apparatus was referred to as the “handheld light.” With the advent of fiber-optic headlights and intracavitary LEDs, the lighting problem was solved.

Above: Egyptian carving depicting circumcision.

Below: A surgeon performs a robotic procedure from a da Vinci surgical system console.

Controlled Painless Sleep For the ability to perform short or extremely prolonged operative procedures, the surgeon is dependent on the anesthesia team to keep the patient in a state of controlled painless sleep. Today, this mandatory component of surgery consists of skillfully blending the administration of somniferous anesthetic gases together with IV agents to promote muscle relaxation, reduce secretions and provide amnesia, facilitated by tracheal intubation and respiratory control with a mechanical ventilator. This combination anesthesia has been called “junk anesthesia”; but it is anything but, because it avoids the harmful effects of the deeper prolonged planes of anesthesia required for surgery by the original anesthetic gases of ether and chloroform. Modern anesthesia allows the patient to be awake in the OR as the last suture is placed.

The origin of the continuous flow anesthesia machine is usually credited to Henry Boyle, a British anesthetist in 1917. What we take for granted in the OR today was absent in the OR until about three surgical generations ago. Without machine-induced anesthesia and ventilation, it is unlikely that Evarts A. Graham would have attempted the first pneumonectomy in 1933, only about two generations of surgeons ago.

Heart–Lung Machine Without the heart–lung machine, open-heart surgery for congenital malformations, valvular degeneration, atherosclerotic coronary artery disease and cardiac transplantation would have been

impossible. The discipline of cardiovascular surgery would essentially be primitive or nonexistent. In the pump-oxygenator, heparinized venous blood removed by gravity is scrubbed of carbon dioxide, oxygenated and returned by a pump into a primary artery. This process allows cardiac arrest and a quiet heart for the surgeon to work on, as well as visualization within an open heart devoid of blood.

Most of the curative or palliative openheart surgeries of today were originated at the University of Minnesota by C. Walton Lillehei, Richard L. Varco, Morley Cohen, Richard C. Lillehei, Norman E. Shumway and others, and were made feasible by the invention of the bubble-oxygenator heart–lung machine in 1955 by Richard A. DeWall, also at the University of Minnesota. The DeWall device was preceded and influenced by an earlier rotating cylinder pump-oxygenator invented by John H. Gibbon of Jefferson University Medical Center, in Philadelphia, in 1934.

Prosthetics Prosthetics have markedly altered the performance of surgery, increasing the

range of operative procedures. They have also eliminated some highly skilled procedures, creating brand-new surgery. For certain, they have revolutionized surgery.

Here are a few examples: Orthopedic surgery was totally altered by the introduction of the artificial hip in 1959, and the artificial knee in 1974. Silicon breast implantations were first available in 1961 and provided plastic surgeons with an entirely new and vast operative domain. Ophthalmologists gained the intraocular lens for cataracts in 1949, otolaryngologists the cochlear implant in 1977 and urologists the artificial urinary sphincter in 1972.

The most prolific surgical field for prosthetics has been cardiovascular: the implantable pacemaker in 1958, the artificial heart valve in 1960, synthetic vascular grafts in the 1970s, the implantable cardiac defibrillator in 1980, coronary artery stents in 1986 and the implantable artificial heart in 2006. We may not yet have the bionic man or woman, but we are close to creating the cardiovascular bionic human.

Minimally Invasive Surgery The introduction, acceptance and proliferation of minimally invasive operations are the second milestone event in the history of surgery, the first being the advent of anesthesia. Cardinal developments of minimally invasive surgery were made in 1901 by Gorg Kelling, in Germany, who performed the first laparoscopic procedure in dogs; in 1910 by Hans Christian Jacobaeus, in Sweden, who did the first laparoscopic procedure in humans; in 1918 by Kenji Takagi, in Japan, credited with the first arthroscopic human operation; and in 1955 by Giancarlo Robiaro, in Italy, who introduced video-assisted thoracic surgery.

Today, an astonishing 15 million continued on page 26

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GENERAL SURGERY NEWS / JUNE 2021

The Scientific Greats: A Series of Drawings

By MOISES MENENDEZ, MD, FACS

Michael Faraday (1791-1867) Michael Faraday was an English scientist who contributed to the study of electromagnetism and electrochemistry. His main discoveries include the principles underlying electromagnetic induction, diamagnetism and electrolysis.

Although Faraday received little formal education, he was one of the most influential scientists in history. It was by his research on the magnetic field around a conductor carrying a direct current that Faraday established the basis for the concept of the electromagnetic field in physics.

Faraday also established that magnetism could affect rays of light and that there was an underlying relationship between the two phenomena. He similarly discovered the principles of electromagnetic induction and diamagnetism, and the laws of electrolysis. His inventions of electromagnetic rotary devices formed the foundation for electric motor technology, and it was largely due to his efforts that electricity became practical for use in technology. Without this technology, it would have been impossible for the advancement of the electric motor that we know today.

Faraday’s contribution to the introduction of general anesthesia was his published announcement in 1818, that inhalation of the vapor of ether produced the same effects on mentation and consciousness as the breathing of nitrous oxide. He most likely became

Tools of Surgery continued from page 24

laparoscopic procedures are performed annually worldwide, 32% of them in the United States, amounting to about 4.8 million operations. Minimally invasive surgery can justifiably be considered the surgery of the present.

Minimally invasive surgery benefits patients and surgeons. The surgery may be more precise. Patients have fewer postoperative complications, pain, days in the hospital and only small scars.

Reciprocally, surgeons have fewer patient complications and spend less time per case, offering the possibility of expanding their practice.

The epochal ascendency of minimally invasive elective surgery has changed the technical performance of surgery as well as the perspective and training of surgeons.

Today’s practicing surgeons think in terms of surgery as being performed by instruments without the sensation of touch and dexterity of human fingers, visually guided and coordinated not by eyes on the actual operative field but on a 2D TV camera image. In many ways, this innovation mirrors today’s world of TV games, virtual communication and depersonalization.

However, there is a major problem in the world of minimally invasive surgery. All minimally invasive surgeons are taught that “if in trouble, open,” that is,

familiar with the central nervous system effects of nitrous oxide through his association with Davy, an avid user of the gas. Sulfuric ether was a common, convenient, cheap and easily available substance, in contrast to nitrous oxide, which required an expensive, cumbersome and probably not widely available apparatus for its production and administration.

A Faraday cage, sometimes known as a Faraday shield, is an enclosure that is used to shield objects from electromagnetic fields (both static and nonstatic). Regarding this discovery, the entire operating room that we are accustomed to is considered a Faraday cage: There is a network of wires in the walls and doors to ensure that electrical charges from outside, such as a lightning strike, cannot enter the room and disrupt an operation. In 1847, William Morton rediscovered anesthesia by using ether and a special device to deliver the gas adequately.

■ Sources Ohry A. Michael Faraday, science, medicine, literature and his disability. Prog Health Sci. 2011;1(2).

Marcet J. La mujer que hizo que el influyente cientifico Michael Faraday se enamorara de la ciencia. Serie “Science Stories.” British Broadcasting Corp. January 14, 2018.

Van de Laar A. Under the Knife. A History of Surgery in 28 Remarkable Operations. Saint Martin’s Press; 2018:296.

—Dr. Menendez is a general surgeon and self-taught portrait artist in Magnolia, Ark. Since 2012, he has completed a series of portraits of historical figures, particularly well-known physicians and surgeons.

Michael Faraday (1791-1867) 2019 Gray toned paper, 15x20, charcoal pencils and white chalk.

Artist: Moises Menendez, MD, FACS

if you hit a major vessel, it may be advantageous to open; if you are uncertain the structure you identified is the cystic duct, open. But the surgeon of today may be a far better laparoscopic surgeon than an open one. Is it, therefore, not illogical to go from expertise to adequacy when the situation demands the highest skill set?

I wrote a column for the February 2016 issue of General Surgery News on this subject, advocating OR availability of a highly trained open surgeon for assistance when it is needed.

a light source, camera and instruments, to laboriously excise the gallbladder.

Hybrid NOTES can be defined as avoiding open or minimally invasive surgery by a very small incision to gain access to an artery for transarterial surgery (e.g., aortic valve replacement, graft bypass of an aortic aneurysm), which has proven to be most worthwhile. It also includes single-port laparoscopic surgery via a barely visible umbilical incision, which may reduce ease of surgery and, therefore, not be considered worthwhile.

NOTES and Hybrid NOTES

Robotics

The earliest record of natural orifice transluminal endoscopic surgery (NOTES) was in 1901 when Dmitri Oskarovich Ott of Russia examined the peritoneal cavity via the vagina. The first human transgastric appendectomy was performed in India in 2004. The abdominal NOTES approach—by gastric, vaginal, colonic perforation—has been utilized to perform cholecystectomies, pancreatic abscess drainage, tubal ligation, oophorectomy, gastrojejunostomy, splenectomy, extirpation of colorectal cancers, and numerous explorations and biopsies.

The attraction of this access to performing surgery is the absence of an external scar. However, the surgeon should consider whether the absence of a scar justifies going through a possibly non-sterile vagina, transversing the entire abdomen with

With reduced complexity of instrumentation and markedly reduced cost, robotic surgery may come to replace standard minimally invasive surgery. Robotic surgery provides ergonomic comfort for the seated surgeon, and the ability of total spatial separation of the patient and the intraoperative robotic arms and instrumentation from the surgeon at the control module. The primary advantages of robotic surgery are 3D visualization, in contrast to the 2D TV image of standard minimally invasive surgery, and adjustable magnification, thereby allowing the surgeon’s movements of the computercontrolled telemanipulator to duplicate the natural hand and arm movements of open surgery. In addition, robotic surgery filters out all hand tremors and secures steady light positioning.

The roots of robotic surgery are varied and complex, involving several inventions, entrepreneurs and instrument companies. Although not exactly new, with origins in the mid-1980s, it is not exactly old either, with only limited usage during the past 20 years. Robotic surgery has been employed in gastrointestinal, gynecologic, urologic, heart, thoracic, orthopedic, eye and neurologic surgery— essentially in all surgical disciplines— in adults and children. In addition to enhancing surgical precision, robotic surgery has been shown to decrease blood loss and postoperative pain, and possibly allow for quicker healing.

On Sept. 7, 2001, the team of Dr. Michel Gagner, at the robot consule in New York City, and Dr. Jacques Marescaux, with the patient in the OR in Strasbourg, France, performed a transcontinental cholecystectomy. This procedure could have served as a whimsical tale for the history of the tools of surgery to the present, if the surgeon had achieved wound closure by robotically snipping off ■ the heads of large-jawed ants.

—Dr. Buchwald is a professor of surgery and biomedical engineering, and the Owen H. and Sarah Davidson Wangensteen Chair in Experimental Surgery (emeritus), at the University of Minnesota, in Minneapolis. His articles appear every other month.

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1. Gagner M, Kemmeter P. Comparison of laparoscopic sleeve gastrectomy leak rates in five staple-line reinforcement options: a systematic review. Surgical Endoscopy 2020;34(1):396-407.

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