When do leaks occur? An analysis of the metabolic and bariatric surgery accreditation and quality improvement program.

BACKGROUND: Leak is a feared complication of bariatric surgeries. Time to presentation is important in their management. We used the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) to evaluate the rate and timing of leaks. OBJECTIVES: To determine when leaks present after bariatric surgery. SETTING: MBSAQIP database. METHODS: The MBSAQIP Participant Use Files (PUF) for the years 2015-2020 were evaluated. Outcomes of interest were "organ space infection" and "leak." We evaluated the time to presentation for these variables as well as patient characteristics, operative time, complication rates and 30-day outcomes. RESULTS: There were 370,369 sleeve gastrectomies (SG) and 159,280 Roux-en-Y gastric bypasses (RYGB). We identified 598 (.16%) SG leaks with an average time to presentation of 13.2 ± 7.8 days. For RYGB, there were 520 leaks (.32%) with an average time to presentation of 9.5 ± 7.4 days. Both procedures had longer operative times for the patients with leak; RYGB was 115 minutes versus 131 minutes and SG was 67 minutes versus 77 minutes (both P < .01). SG and RYGB patients with a leak had a higher relative risk (RR) of grade 4 and 5 Clavien-Dindo complication rates. RR of mortality rates in SG patients with leak was 35.2 (confidence interval (CI): 20-61) and in RYGB with leak was 31.4 (CI: 19-50). CONCLUSIONS: The length of time for SG leak presentation was more delayed than RYGB leak presentation. Surgeons should be vigilant for leaks for at least 3 weeks after surgery. Leaks increase the mortality rate and overall serious complications.

Rates of Readmission and Emergency Department Visits of Publicly Versus Commercially Insured Patients in a Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program Accredited Center.

Background: Patients with governmental insurance are known to utilize the emergency department (ER) at a higher rate and have higher readmission rates than other patients. Twenty percent of our patients are publicly insured. Our objective was to determine if there was a higher rate of readmissions and ER visits within 30 days in publicly insured patients. Methods: Data was analyzed from a single center submitted to the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program Participant Use Data File from January 1, 2015 to December 31, 2018. We added insurance status and described quantitative variables using mean, and standard deviation (SD). These were reported as regression coefficients (RC) and prevalence ratio (PR), along with their 95% confidence interval (CI). P values of less than 5% were considered statistically significant. Results: The overall rate of ER visits, readmissions, and reoperations were 3.5%, 7.4%, and 2.2% respectively. Medicaid and Medicare patients were found to have longer operative times, 62.7 minutes vs 57.5 minutes (p = 0.35). Patients on public insurance had higher adjusted risk of ER visits (PR 1.43, 95% CI: 0.41-5.3; p = 0.58) and readmissions (PR 1.64, 95% CI: 0.76-3.55; p = 0.21) than patients on commercial/self-pay insurance. Re-operations were lower in the publicly insured group (PR 0.93, 95% CI: 0.2-4.7; p = 0.92) than patients on commercial/self-pay insurance. However, these outcomes were not statistically significant. Conclusions: Publicly insured patients tend to have a higher adjusted risk of ER visits and readmissions but was not statistically significant. The rate of re-operation was slightly lower in publicly insured patients.

Stapler Malfunctions in Bariatric Surgery: An Analysis of the MAUDE Database.

Background: Staple line leaks are a serious problem in bariatric surgery and a major cause of serious morbidity and mortality. Adverse events caused by medical devices are reported to the Food and Drug Administration which maintains the Manufacturer and User Facility Device Experience (MAUDE) database. We examined adverse stapler events reported to the MAUDE database, specifically with regards to bariatric surgery. Methods: The MAUDE database was queried for adverse events caused by staplers between January 1, 2018 - December 31, 2020; events reported by Intuitive, Ethicon, and Medtronic/Covidien; and limited our search to "gastric bypass", "sleeve gastrectomy", "stapler malfunction" combined with each company. Results: There were 883 adverse events reported for Medtronic, 353 for Ethicon, and 35 for Intuitive. Approximately 3.5 million staple reloads sold in the study period. The reported misfire rate for Medtronic was 0.04% and for Ethicon was 0.02%. Data for Intuitive was unavailable. The most common reported event for Medtronic was failure to fire (n = 349), followed by misfire (n = 186). For Ethicon, the most common event was failure to fire (n = 146), followed by mechanical problems (n = 27). The most common event with the Intuitive stapler was leak (n = 10) and bleeding from staple line (n = 8). Conclusions: Stapler malfunction is a very rare event in metabolic and bariatric surgery. All of the major stapler producers have transitioned to powered staplers with excellent safety profiles. Open and honest reporting about stapler malfunction is essential to determine the true safety of these ubiquitous devices.

Is fundoplication necessary after paraesophageal hernia repair? A meta-analysis and systematic review.

INTRODUCTION: Paraesophageal hernias are often asymptomatic, but when symptomatic they should be fixed laparoscopically. A cruroplasty of the diaphragmatic pillars is performed and a fundoplication is usually performed at the time. However, there are times, especially in emergency cases, where it is not always possible to perform a fundoplication. We hypothesized there would be no difference in outcomes whether or not a fundoplication is performed as part of a paraesophageal hernia repair. METHODS: A literature review of available clinical databases was performed using PubMed, Clinical Key and Google Scholar. Our search terms were: "paraesophageal hernia" "paraesophageal hernia repair" "fundoplication" "emergency surgery" "no fundoplication" We excluded studies that were in languages other than English, abstracts and small case series. RESULTS: Our search criteria yielded a total of 22 studies published between 1997 and 2020. There were a total of 8600 subjects enrolled into this study. The overall pooled prevalence of fundoplication were estimated as 69% (95% CI: 59%-78%). In patients who underwent fundoplication, the risk of gastroesophageal reflux disease (GERD) was reduced as compared to patients who did not undergo fundoplication (RR: 0.64, 95% CI: 0.40-1.04, p = 0.069, I2 = 47.2%). A similar trend was also observed in recurrence (RR: 0.53, 95% CI: 0.27-1.03, p = 0.061, I2 = 0.0%) and reoperations (RR: 0.25, 95% CI: 0.02-2.69, p = 0.25, I2 = 56.7%). However, patients who underwent fundoplication had an increased risk of dysphagia (RR: 1.68, 95% CI: 0.59-4.81, p = 0.83, I2 = 42%). CONCLUSIONS: There is a higher rate of recurrence of gastroesophageal reflux disease, recurrence of hernia and reoperation when no fundoplication is performed during a paraesophageal hernia repair but a lower risk of dysphagia, but none of these reached statistical significance.(Comment 1) Paraesophageal hernia repair with fundoplication should be performed, but it is acceptable to not do it in certain situations.

Long Term Outcomes after Laparoscopic Assisted Trans-Gastric Endoscopic Retrograde Cholangiopancreatography.

BACKGROUND: The gastric bypass is a commonly performed bariatric procedure. The stomach is divided into a small pouch as well as leaving a larger remnant that is bypassed by the gastrojejunal anastomosis. This makes access to the biliary system difficult as an endoscope cannot transverse the esophagus, roux limb, and biliopancreatic limb. Therefore, a transgastric approach (endoscopic retrograde cholangiopancreatography [t-ERCP]) through the abdominal wall and remnant stomach is necessary. This involves the surgical team providing access to the remnant stomach for the gastroenterologist to perform the t-ERCP. We have performed a number of these for biliary pathology that ranges from cancer to retained gallstones. We evaluated these patients with at least a 3-year follow-up to determine long term outcomes. METHODS: We conducted a chart review of patients who underwent a t-ERCP with at least a 3-year follow-up. We collected de-identified data including demographics, operative details, complications, and postoperative courses. RESULTS: There were 12 patients who underwent t-ERCP. Eleven patients had at least a 3-year follow-up with a mean follow-up of 68.1 months (excluding one death from pancreatic cancer). The most common pathology was benign biliary stricture (n = 6), followed by retained gallstones (n = 4), with one pancreatic cancer, and one normal examination. Two patients still had epigastric pain at long term follow-up after 3 years. CONCLUSION: T-ERCP is safe and efficacious with good long-term results.

Reluctance in duodenal switch adoption: an international survey among bariatric surgeons.

BACKGROUND: Duodenal switch (DS) still comprises less than 1% of the overall primary procedures in the United States. Our aim is to explore the reasons behind surgeons' reluctance to DS adoption. OBJECTIVES: To determine perceived reasons for the widespread lack of adoption of the DS. SETTING: Worldwide survey of closed bariatric surgery social media groups. METHODS: A standardized questionnaire was posted on 2 closed social media bariatric groups. DS was used as an umbrella term that includes traditional BPD with duodenal switch, single anastomosis duodeno-ileostomy (SADI) and loop DS. The questionnaire link was accessible to bariatric surgeons only for a period of 1 week. RESULTS: Survey responses (n = 193) were analyzed. The majority (75%) were fellowship-trained bariatric surgeons, and 58% were practicing in the United States. Although 72.9% believed DS to be a good bariatric procedure, it was not being performed by 64% of the respondents. The main reasons behind DS nonadoption included a perceptible high long-term complication rate (43.5%), lack of training (38.1%), and procedure seldomly demanded by patients (31.5%). For surgeons who perform DS, 16.4% use it as a revisional procedure, mainly following sleeve gastrectomy (40.5%). Finally, 29.5% of surgeons believed that the American Society of Metabolic and Bariatric Surgery endorsement of SADI will encourage them to add DS to their practice. They are mostly planning to do so by visiting other surgeons and getting proctored (42.6%). CONCLUSION: This survey will help guide bariatric societies and governing bodies in addressing the issues and concerns preventing surgeons from adopting DS in their practice by elucidating the chief reasons and circumstances behind this occurrence.