Implementation of entrustable professional activities into fellowship council accredited programs: a pilot project.

OBJECTIVE: The Fellowship Council (FC) is transitioning to a competency-based medical education (CBME) model, including the introduction of Entrustable Professional Activities (EPAs) for training and assessment of Fellows. This study describes the implementation process employed by the FC during a ten-month pilot project and presents data regarding feasibility and perceived value. METHODS: The FC coordinated the development of EPAs in collaboration with the sponsoring societies for Advanced GI/MIS, Bariatrics, Foregut, Endoscopy and Hepatopancreaticobiliary (HPB) fellowships encompassing the preoperative, intraoperative, and postoperative phases of care for key competencies. Fifteen accredited fellowship programs participated in this project. The assessments were collected through a unique platform on the FC website. Programs were asked to convene a Clinical Competency Committee (CCC) on a quarterly basis. The pilot group met monthly to support and improve the process. An exit survey evaluated the perceived value of EPAs. RESULTS: The 15 participating programs included 18 fellows and 106 faculty. A total of 655 assessments were initiated with 429 (65%) completed. The average (SD) number of EPAs completed for each fellow was 24(18); range 0-72. Intraoperative EPAs were preferentially completed (71%). The average(SD) time for both the fellow and faculty to complete an EPA was 27(78) hours. Engagement increased from 39% of fellows completing at least one EPA in September to 72% in December and declining to 50% in May. Entrustment level increased from 6% of EPAs evaluated as "Practice Ready" in September to 75% in June. The exit survey was returned by 63% of faculty and 72% of fellows. Overall, 46% of fellows and 74% of program directors recommended full-scale implementation of the EPA framework. CONCLUSION: A competency-based assessment framework was developed by the FC and piloted in several programs. Participation was variable and required ongoing strategies to address barriers. The pilot project has prepared the FC to introduce CBME across all FC training programs.

Gender disparities in gastrointestinal surgery fellowship programs.

BACKGROUND: Gender disparities in surgical leadership have come under increased scrutiny, and in order to better understand why these disparities exist, it is important to study the disparities across surgical fellowship programs. METHODS: Data derived from the Fellowship Council (FC) database for fellows completing training from academic years 2015-2019 were analyzed. Available information included institution, fellowship type, program director (PD), associate program director (APD), faculty, and fellow names for all FC Fellowships. Faculty and fellow gender were determined from personal knowledge or publicly available online biographical information. RESULTS: A total of 1023 fellows and 221 programs were analyzed. The advanced gastrointestinal (GI)/minimally invasive surgery (MIS) fellowship programs included 321 fellows, with a small increase in the percentage of female fellows from 28 to 31% over 5 years. Advanced GI/MIS/bariatric fellowship programs had a total of 262 fellows, also with a small increase in the percent of female fellows, from 29 to 38% in the study period. The gender of program directors, assistant program directors, and faculty for the fellowship programs studied were analyzed as well. Of the 221 programs in the Fellowship Council data, 13.6% of program directors, 18.3% of associate program directors, and 19.9% of faculty were female. Advanced GI/MIS fellowship programs had the lowest percentage of female PDs, with only 9.3% of the program directors being female. Colorectal surgery fellowships had the highest percentage of female PDs, with 33% being female. CONCLUSIONS: In conclusion, women are underrepresented in gastrointestinal surgery fellowships among both trainees and educators. It is likely that a significant contributing factor to this underrepresentation of female fellows is the underrepresentation of female program directors and faculty; although neither our study nor any previously published study has proven that statistically.

Defining benchmarks for fellowship training in foregut surgery: a 10-year review of fellowship council index cases.

INTRODUCTION: Surgical treatment of foregut disease is a complex field that demands advanced expertise to ensure favorable outcomes for patients. To address the growing need for foregut surgeons, leaders within several national societies have become interested in developing a foregut fellowship. The aim of this study was to develop data-driven benchmarks that will aid in defining appropriate accreditation criteria for these fellowships. METHODS: We obtained case log data for Fellowship Council fellows trained from 2009-2019. We identified 78 complex foregut (non-bariatric) case codes and divided them into 5 index case categories including (1) hiatal/paraoesophageal hernia repair, (2) fundoplication, (3) esophageal myotomy, (4) major organ resection, and (5) minor organ resection. Median volumes in each index category were compared over time using Kruskall-Wallis tests. The share of cases done using open, laparoscopic, or robotic approaches were analyzed using linear regression analysis. RESULTS: For the 10 years analyzed, 1362 fellows logged 82,889 operations and 111,799 endoscopies. Median foregut cases per fellow grew significantly from 42 (IQR = 24-74) cases in 2010 to 69 (IQR = 33-106) cases in 2019. Median endoscopy volumes also grew significantly from 42 (IQR = 7-88) in 2010 to 69 (IQR 32-123) in 2019.The volume of hiatal/paraoesophageal hernia repairs increased significantly over time while volumes in the remaining 4 index categories remained stable. The share of robotic cases exhibited near perfect linear growth from 2.2% of all foregut cases in 2010 to 14.4% in 2019 (R = 0.99, p < 0.0001). Open cases exhibited linear decay from 7.2% of cases in 2010 to 4.7% of cases in 2019 (R = 0.92, p = 0.0001). Laparoscopic/thoracoscopic cases also exhibited linear decay from 90.6% of cases in 2010 to 80.9% of cases in 2019 (R = 0.98, p < 0.00001). CONCLUSIONS: FC fellows are exposed to robust volumes of foregut cases. This rich data set provides an evidence-based guide for establishing criteria for potential foregut fellowships.

Laparoscopic vagal nerve blocking device explantation: case series and report of operative technique.

BACKGROUND: Vagal nerve blockade with the vBloc device (ReShape Lifesciences, St. Paul, MN) has been shown to provide durable 2-year weight loss in patients with moderate obesity. These devices may require removal. We present a series of patients and report our technique for laparoscopic removal of this device. METHODS: From December 2009 to December 2016, the medical records of patients who underwent laparoscopic explantation of a vagal blocking device at our institution were retrospectively reviewed. All patients initially underwent device placement as part of a multi-center, randomized, controlled trial. The device leads were removed with the application of firm traction in order to safely dissect them away from the stomach and esophagus as the body tended to form a fibrotic capsule surrounding the leads. Operative details, length of stay, 30-day post-operative complications, demographics and reasons for device removal were reported. RESULTS: Thirty patients were identified. Median age was 54 (37-65) years. Average operative time was 227.63 (± 100.21) min. Median time from implantation to removal was 41 (11-96) months. Removal reasons included device malfunction (7 patients, 23.3%), pain at the neuroregulator site (5 patients, 16.7%), retrosternal or epigastric pain (11 patients, 36.7%), weight regain or dissatisfaction with weight loss (15 patients, 50%), and severe nausea (2 patients, 6.7%). Two patients (6.7%) had Clavien-Dindo grade II complications following explantation. Thirteen patients (43.3%) had dense adhesions noted at the time of operation. Seroma formation at the neuroregulator site was the most common complication (7 patients, 23.3%). CONCLUSION: The vagal nerve blocking device can be safely removed laparoscopically with a low 30-day complication rate. Surgeons should be familiar with the details of the device appearance, the typical lead location, and should anticipate dense adhesions surrounding the leads. In addition, experience operating in the region of the gastroesophageal junction is imperative.

Influence of dietary protein on glomerular filtration before and after bariatric surgery: a cohort study.

BACKGROUND: Obesity-associated elevations in glomerular filtration rate (GFR) are common and may play a role in the development of kidney disease, so identifying the underlying mechanism is important. We therefore studied whether reductions in dietary protein intake, which is known to modulate GFR, explain why GFR decreases after bariatric surgery-induced weight loss. STUDY DESIGN: Cohort study with participants as their own controls. SETTING & PARTICIPANTS: 8 severely obese patients with normal kidney function were recruited from bariatric surgery centers in Indianapolis, IN. All participants were placed on a fixed-protein (50-g/d) diet for 1 week before and after a minimum of a 20-kg weight loss by bariatric surgery and were followed up closely by dieticians for adherence. PREDICTOR: Ad lib versus low-protein diet before versus after bariatric surgery. OUTCOME: Measured GFR, using repeated-measures analysis, was used to estimate the independent effects of diet and surgery. MEASUREMENT: GFR was measured using plasma iohexol clearance. RESULTS: A median of 32.9 (range, 19.5-54.4)kg was lost between the first presurgery visit and first postsurgery visit. Dietetic evaluations and urinary urea excretion confirmed that patients generally adhered to the study diet. GFRs on an ad lib diet were significantly higher before compared to after surgery (GFR medians were 144 (range, 114-178) and 107 (range, 85-147) mL/min, respectively; P=0.01). Although bariatric surgery (-26mL/min; P=0.005) and dietary sodium intake (+7.5mL/min per 100mg of dietary sodium; P=0.001) both influenced GFR, consuming a low-protein diet did not (P=0.7). LIMITATIONS: Small sample size; mostly white women; possible lack of generalizability. CONCLUSIONS: The decrease in GFR observed after bariatric surgery is explained at least in part by the effects of surgery and/or dietary sodium intake, but not by low dietary protein consumption.

Predicting the glomerular filtration rate in bariatric surgery patients.

BACKGROUND/AIMS: Identifying the best method to estimate the glomerular filtration rate (GFR) in bariatric surgery patients has important implications for the clinical care of obese patients and research into the impact of obesity and weight reduction on kidney health. We therefore performed such an analysis in patients before and after surgical weight loss. METHODS: Fasting measured GFR (mGFR) by plasma iohexol clearance before and after bariatric surgery was obtained in 36 severely obese individuals. Estimated GFR was calculated using the Modification of Diet in Renal Disease equation, the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation using serum creatinine only, the CKD-EPI equation using serum cystatin C only and a recently derived equation that uses both serum creatinine and cystatin C (CKD-EPIcreat-cystC) and then compared to mGFR. RESULTS: Participants were primarily middle-aged white females with a mean baseline body mass index of 46 ± 9, serum creatinine of 0.81 ± 0.24 mg/dl and mGFR of 117 ± 40 ml/min. mGFR had a stronger linear relationship with inverse cystatin C before (r = 0.28, p = 0.09) and after (r = 0.38, p = 0.02) surgery compared to the inverse of creatinine (before: r = 0.26, p = 0.13; after: r = 0.11, p = 0.51). mGFR fell by 17 ± 35 ml/min (p = 0.007) following surgery. The CKD-EPIcreat-cystC was unquestionably the best overall performing estimating equation before and after surgery, revealing very little bias and a capacity to estimate mGFR within 30% of its true value over 80% of the time. This was true whether or not mGFR was indexed for body surface area. CONCLUSIONS: In severely obese bariatric surgery patients with normal kidney function, cystatin C is more strongly associated with mGFR than is serum creatinine. The CKD-EPIcreat-cystC equation best predicted mGFR both before and after surgery.

What is wrong with the training of general surgery?

The practice of surgery has undergone tumultuous changes over the last 30 years. Disease management, trauma volume, operative techniques, supervision requirements, and allocation of work hours have all changed, resulting in a substantial impact on general surgical training. Changes need to occur in the structure, assessment, and mentorship of future residents to prepare them to enter the marketplace and practice safe medicine with confidence and authority.

Pharmacokinetic and pharmacodynamic alterations in the Roux-en-Y gastric bypass recipients.

OBJECTIVE: We conducted a pharmacokinetic (PK) study and a pharmacodynamic (PD) study to assess whether Roux-en-Y gastric bypass (RYGB) surgery is associated with significant changes to PK and PD of oral medications. BACKGROUND: The effect of RYGB on oral drug disposition is not well understood. METHODS: An oral cocktail of probe drugs for major drug-metabolizing enzymes (caffeine, tolbutamide, omeprazole, dextromethorphan, and oral and intravenous midazolam) was administered to 18 RYGB recipients and 18 controls. Timed blood and urine samples were obtained for PK analyses. Forty mg of oral furosemide was administered to 13 RYGB recipients and 14 controls, and urine and blood samples were collected for assessing furosemidePK, and urine volume and urine sodium excretion for PD analyses. RESULTS: Compared with controls, the RYGB group had significantly lower time to maximum plasma concentration (tmax) for caffeine (0.58 ± 0.5 vs 2.1 ± 2.2 hours, P < 0.0001), tolbutamide (1.4 ± 1.8 vs 2.1 ± 2.2 hours, P = 0.0001), omeprazole (1.1 ± 1.1 vs 4.4 ± 1.3 hours, P < 0.0001), and oral midazolam (0.5 ± 0.2 vs 0.7 ± 0.4 hours, P < 0.01). However, maximum plasma concentration, half-life, area under the curve, and oral bioavailability were not different. Compared with controls, the RYGB group had brisk natriuresis, with significantly lower tmax for urine sodium (1.3 ± 0.5 vs 3.1 ± 2.3 hours, P < 0.02) and correspondingly lower tmax for furosemide (1.8 ± 0.3 vs 4.2 ± 1.2 hours, P = 0.006). However, 6-hour urine sodium and 6-hour urine volume were not different between the two groups. CONCLUSIONS: RYGB recipients have significantly shorter tmax for the studied orally administered medications, but otherwise no other significant changes in PK were reported.

General surgery residency inadequately prepares trainees for fellowship: results of a survey of fellowship program directors.

OBJECTIVE: To assess readiness of general surgery graduate trainees entering accredited surgical subspecialty fellowships in North America. METHODS: A multidomain, global assessment survey designed by the Fellowship Council research committee was electronically sent to all subspecialty program directors. Respondents spanned minimally invasive surgery, bariatric, colorectal, hepatobiliary, and thoracic specialties. There were 46 quantitative questions distributed across 5 domains and 1 or more reflective qualitative questions/domains. RESULTS: There was a 63% response rate (n = 91/145). Of respondent program directors, 21% felt that new fellows arrived unprepared for the operating room, 38% demonstrated lack of patient ownership, 30% could not independently perform a laparoscopic cholecystectomy, and 66% were deemed unable to operate for 30 unsupervised minutes of a major procedure. With regard to laparoscopic skills, 30% could not atraumatically manipulate tissue, 26% could not recognize anatomical planes, and 56% could not suture. Furthermore, 28% of fellows were not familiar with therapeutic options and 24% were unable to recognize early signs of complications. Finally, it was felt that the majority of new fellows were unable to conceive, design, and conduct research/academic projects. Thematic clustering of qualitative data revealed deficits in domains of operative autonomy, progressive responsibility, longitudinal follow-up, and scholarly focus after general surgery education.

Mesenteric fat cryolipolysis attenuates insulin resistance in the Ossabaw swine model of the metabolic syndrome.

BACKGROUND: The rising prevalence of insulin resistance (IR), metabolic syndrome, and type 2 diabetes are associated with increases in abdominal mesenteric fat. Adipocytes are sensitive to low temperatures, making cryolipolysis of mesenteric fat an attractive treatment modality to potentially reduce IR. OBJECTIVES: We aimed to determine whether (1) cryolipolysis is safe in reducing the volume of the mesenteric fat and (2) reduction in mesenteric fat volume reduces indices of IR and glycemic dysfunction. SETTING: Indiana University School of Medicine. METHODS: A novel cooling device and method delivered cryolipolysis in a controlled manner to avoid tissue ablative temperatures. Ossabaw pigs (n = 8) were fed a high-fat diet for 9 months to develop visceral obesity, IR, and metabolic syndrome. Following laparotomy, mesenteric fat cryolipolysis (MFC) was performed in 5 pigs, while 3 served as sham surgery controls. The volume of the mesenteric fat was measured by computed tomography and compared with indices of glucose intolerance before and at 3 and 6 months postprocedure. RESULTS: MFC safely reduced mesenteric fat volume by ∼30% at 3 months, which was maintained at 6 months. Body weight did not change in either the MFC or sham surgery control groups. Measure of glycemic control, insulin sensitivity, and blood pressure significantly improved after MFC compared with sham controls. CONCLUSION: MFC reduces the volume of mesenteric fat and improves glycemic control in obese, IR Ossabaw pigs, without adverse effects.

Laparoscopic sleeve gastrectomy for super obese patients: forty-eight percent excess weight loss after 6 to 8 years with 93% follow-up.

OBJECTIVES: In this study, we report long-term outcomes of high-risk, high-BMI (body mass index) patients who underwent laparoscopic sleeve gastrectomy (LSG). BACKGROUND: Short- and medium-term data appear to support the effectiveness of LSG, but long-term data to support its durability are sparse. METHODS: A prospective database was reviewed on all high-risk patients who underwent LSG as part of a staged approach for surgical treatment of severe obesity between January 2002 and February 2004. We included only patients who did not proceed to second-stage surgery (gastric bypass). Analyzed data included demographics, BMI, comorbidities, and surgical outcomes. All partial gastrectomies were performed using a 50F bougie. RESULTS: Seventy-four patients underwent LSG, and follow-up data were available on 69 of 74 patients (93%). The mean age was 50 years (25-78) and the mean number of co-morbidities was 9.6. Perioperative mortality (<30 days) was zero, and the incidence of short- and long-term postoperative complications was 15%. The mean overall follow-up time period was 73 months (38-95). Mean excess weight loss (EWL) at 72, 84, and 96 months after LSG was 52%, 43%, and 46%, respectively, with an overall EWL of 48%. The mean BMI decreased from 66 kg/m(2) (43-90) to 46 kg/m(2) (22-73). Seventy-seven percent of the diabetic patients showed improvement or remission of the disease. CONCLUSIONS: This study reports the longest follow-up of LSG patients thus far and supports the effectiveness, safety, and durability of laparoscopic sleeve gastrectomy as a definitive therapeutic option for severe obesity, even in high-risk, high-BMI patients.

Response of gut hormones after implantation of a reversible gastric restrictive device in different animal models.

BACKGROUND: Variable responses of gut hormones have been observed after bariatric procedures. The aim of the present study was to evaluate the ghrelin, glucagon-like peptide 1 (GLP-1), and leptin levels in nonobese canine and obese rat models after weight loss owing to a reversible gastric restriction (RGR) device. METHODS: Mongrel dogs and obese Zucker rats were submitted to either surgical implantation or a sham operation and were followed up for 6 wk. The serum fasting ghrelin, GLP-1, and leptin levels in dogs were measured using enzyme-linked immunosorbent assay before and after surgical implantation and after implant removal. The protein expression of mucosa ghrelin, GLP-1, and leptin in the dog and rat stomach were measured using Western blotting. RESULTS: The RGR implant in dogs and rats resulted in a significant decrease in food intake and body weight. In the nonobese dog, the serum ghrelin level and mucosa ghrelin expression were significantly increased after surgical implantation (P < 0.05) and tended to recover after implant removal. In the obese rat, mucosa ghrelin expression decreased by about 27% (P = 0.06) 6 wk after implantation. A lower serum leptin level in dogs and lower mucosa leptin expression in dogs and rats was observed after surgical implantation compared with the sham procedure (P < 0.05). The RGR implant had no influence on the serum GLP-1 level in dogs or mucosa GLP-1 expression in either animal model. CONCLUSIONS: Our results showed that ghrelin levels are downregulated with short-term RGR implantation in obese rats but upregulated in nonobese dogs, implying that the energy balance could be an important determinant of ghrelin level. The marked suppression of leptin in both animal models might contribute to the weight-reducing effect of the RGR implant.

Deep sedation in natural orifice transluminal endoscopic surgery (NOTES): a comparative study with dogs.

BACKGROUND: Natural orifice transluminal endoscopic surgery (NOTES) has been mostly performed with the animal under general and inhalational anesthesia (IA-NOTES). To date, NOTES using propofol sedation (PS-NOTES) has not been investigated. This study aimed to assess the feasibility and safety of PS-NOTES for transgastric oophorectomy with carbon dioxide insufflation and to compare its success rates with those of conventional IA-NOTES. METHODS: In this prospective randomized study, NOTES oophorectomy was performed for 19 female dogs randomized to two conditions: PS (study group) and IA (control group). Sedation success rates (ability to visualize and resect ovaries without converting to IA), operative success rates (ability to resect and retrieve both ovaries in full using only NOTES), and vital parameters including hemodynamic and respiratory changes were documented. RESULTS: In the PS-NOTES group (n = 9), the sedation success rate was 100 %. The operative success rate was 67 % (6 of 9 animals) compared with 80 % (8 of 10 animals) in the IA-NOTES group. No purposeful movement occurred during surgical manipulation and no respiratory or cardiovascular complications in occurred the PS group. Heart rate (HR) and end-tidal carbon dioxide (ETCO(2)) were significantly higher in the PS group than in the IA group. Blood pressure (BP) was significantly higher in the PS group only during the middle part of the procedure. Only mild respiratory depression was noted in the PS group, as indicated by elevated but acceptable ETCO(2). Elevations in BP and HR are thought to be related to elevated CO(2) but did not appear to have an adverse impact on the course of the procedure. Recovery was uneventful for all the animals. CONCLUSION: The use of PS-NOTES appears to be feasible, resulting in outcomes comparable with those for IA in dogs. Further studies are needed to determine the applicability of this concept in human NOTES.

First report from the American Society of Metabolic and Bariatric Surgery closed-claims registry: prevalence, causes, and lessons learned from bariatric surgery medical malpractice claims.

BACKGROUND: Bariatric surgery has demonstrated sustained improvements in quality. Malpractice closed claims have been offered as a means of assessing quality. Few studies have investigated malpractice closed claims and opportunities for improvement in bariatric surgery. OBJECTIVES: To examine the prevalence and causes of malpractice claims with examination of prospects for quality improvement. SETTING: University hospital, United States; private practice. METHODS: Four national malpractice insurers participated in the closed-claims registry. Data regarding patients, staff, procedures, and hospital status were gathered from closed-claims files. Following data collection, a clinical summary of each closed claim was collected and later assessed by an expert panel on the basis of the following: contributing diagnosis and treatment events; whether complications were potentially preventable by the surgeon; the role of language, fatigue, distraction, workload, or teaching hospital/trainee supervision; communication concerns; and final care determination. RESULTS: A total of 175 closed claims were collected from index bariatric surgeries within the period from 2006-2014. Of these, 75.9% of surgeons were board certified and 43.3% of the hospitals were accredited for bariatric surgery. Most clinical complications after bariatric surgery that led to malpractice lawsuits were mortality (35.1%) and leaks (17.5%). While they were not the common cause for malpractice suits, bleeding (5.3%), retained foreign body (5.3%), and vascular injury (4.4%) occurred at higher rates than national averages. CONCLUSION: Prevalence of malpractice claims regarding bariatric surgery is low. Failure to diagnose, delay in treatment, postoperative care, and communication domain responses indicate future opportunities for improvement.

Measuring ketone bodies for the monitoring of pathologic and therapeutic ketosis.

BACKGROUND: The ketone bodies ß-hydroxybutyrate (BOHB) and acetone are generated as a byproduct of the fat metabolism process. In healthy individuals, ketone body levels are ∼0.1 mM for BOHB and ∼1 part per million for breath acetone (BrAce). These levels can increase dramatically as a consequence of a disease process or when used therapeutically for disease treatment. For example, increased ketone body concentration during weight loss is an indication of elevated fat metabolism. Ketone body measurement is relatively inexpensive and can provide metabolic insights to help guide disease management and optimize weight loss. METHODS: This review of the literature provides metabolic mechanisms and typical concentration ranges of ketone bodies, which can give new insights into these conditions and rationale for measuring ketone bodies. RESULTS: Diseases such as heart failure and ketoacidosis can affect caloric intake and macronutrient management, which can elevate BOHB 30-fold and BrAce 1000-fold. Other diseases associated with obesity, such as brain dysfunction, cancer, and diabetes, may cause dysfunction because of an inability to use glucose, excessive reliance on glucose, or poor insulin signaling. Elevating ketone body concentrations (e.g., nutritional ketosis) may improve these conditions by forcing utilization of ketone bodies, in place of glucose, for fuel. During weight loss, monitoring ketone body concentration can demonstrate program compliance and can be used to optimize the weight-loss plan. CONCLUSIONS: The role of ketone bodies in states of pathologic and therapeutic ketosis indicates that accurate measurement and monitoring of BOHB or BrAce will likely improve disease management. Bariatric surgery is examined as a case study for monitoring both types of ketosis.

Bariatric surgery-induced weight loss reduces hepatic lipid peroxidation levels and affects hepatic cytochrome P-450 protein content.

OBJECTIVE: To evaluate the effects of surgical weight loss on hepatic lipid peroxidation levels and cytochrome P-450 protein expression in patients with nonalcoholic fatty liver disease (NAFLD). SUMMARY BACKGROUND DATA: NAFLD and nonalcoholic steatohepatitis (NASH) affect hepatic cytochrome P-450 (CYP) protein expression and activity, and CYP2E1 may play a role in the pathogenesis of NAFLD and NASH through induction of oxidative stress and lipid peroxidation. NAFLD and NASH are associated with increased systemic lipid peroxidation levels and elevated hepatic CYP2E1 activity, but hepatic CYP3A4/5 activity is decreased. METHODS: Liver biopsies from 20 patients with NAFLD who underwent bariatric surgery were obtained intraoperatively and at 15 +/- 7 months following surgery. Hepatic malondialdehyde (MDA) levels (a marker of lipid peroxidation), CYP2E1 and CYP3A4/5 protein expression, and steatosis, as a percent of total area, were measured by immunohistochemistry followed by digital image quantitation. RESULTS: Following weight loss, as reflected by reduced BMI (54 +/- 9 vs. 37 +/- 9 kg/m2; P < 0.001), features of the metabolic syndrome, grade and stage of liver disease, and liver histology were all significantly improved (P < 0.01). Hepatic MDA staining (35 +/- 18% vs. 23 +/- 14%; P = 0.02), CYP2E1 protein content (68 +/- 9% vs. 56 +/- 11%; P < 0.001), and steatosis (17 +/- 7% vs. 2 +/- 3%; P < 0.001) were significantly reduced following weight loss. CYP3A4/5 protein content was unchanged (57 +/- 13% vs. 55 +/- 13%; P = 0.433). The reduction in lipid peroxidation was independently associated with changes in CYP2E1 protein expression after bariatric surgery (r = 0.477; P = 0.033). CONCLUSION: Elevations in hepatic lipid peroxidation and CYP2E1 expression that are seen in NAFLD improve significantly with weight loss induced by bariatric surgery.

A prospective randomized trial of sham, single-dose Stretta, and double-dose Stretta for the treatment of gastroesophageal reflux disease.

BACKGROUND: Gastroesophageal reflux disease (GERD) is a prevalent disorder that often requires long-term medical therapy or surgery. Radiofrequency (RF) energy delivery (Stretta procedure) has been shown in several studies to improve GERD symptoms and quality of life for approximately two-thirds of patients. The authors proposed that increasing the dose of Stretta would further improve the response to this therapy. METHODS: For this study, 36 patients were randomized into three groups. In group A, 12 patients underwent a single session Stretta procedure. In group B, 12 patients under went a sham Stretta procedure (mirror of the active procedure in all aspects except there was no deployment of the electrodes). In group C, 12 patients underwent a single Stretta treatment followed by repeat Stretta if GERD health-related quality of life (HRQL) was not 75% improved after 4 months. For each patient, 56 RF lesions were created per session. The principal outcome was GERD HRQL improvement. The secondary outcomes were medication use, lower esophageal sphincter (LES) basal pressure, endoscopic grade of esophagitis, and esophageal acid exposure by pH probe. RESULTS: The Stretta procedure was completed successfully for all the patients in both active treatment groups. At 12 months, the mean HRQL scores of those off medications, the LES basal pressure, the 24-h pH scores, and the proton pump inhibitor (PPI) daily dose consumption were significantly improved from baseline in both Stretta groups (p\0.01). The double Stretta was numerically but not significantly better than the single Stretta for mean HRQL, mean 24 h pH, mean LES pressure, and PPI use. Seven patients in the double Stretta treatment group had normalized their HRQL at 12 months compared with 2 patients in the single-treatment group (p = 0.035). The sham patients had a small but statistically significant decrease in their daily PPI dosages (p\0.05) and mean HRQL scores (p\0.05). No serious complications (bleeding, perforation, or death) occurred. However, two patients experienced significant delayed gastric emptying after the second Stretta treatment. CONCLUSIONS: The Stretta procedure significantly reduced GERD HRQL, use of PPI drugs, esophageal acid exposure, LES pressure, and grade of esophagitis compared with the sham procedure. The double Stretta therapy had numerically superior outcomes for most parameters and a significantly more frequent normalization of HRQL scores compared with the single Stretta.

American Society for Metabolic and Bariatric Surgery 2018 estimate of metabolic and bariatric procedures performed in the United States.

BACKGROUND: Metabolic and bariatric surgery, despite being the only effective durable treatment for obesity, remains underused as approximately 1% of all patients who qualify undergo surgery. The American Society for Metabolic and Bariatric Surgery created a Numbers Taskforce to specify annual rate of utilization for obesity treatment interventions and to determine if patients in need are receiving appropriate therapy. OBJECTIVES: The objective of this study was to provide the best estimated number of metabolic and bariatric procedure performed in the United States in 2018. SETTING: United States. METHODS: We reviewed data from the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program, National Surgical Quality Improvement Program, Bariatric Outcomes Longitudinal Database, and Nationwide Inpatient Sample. In addition, data from industry and outpatient centers were used to estimate outpatient center activity. Data from 2018 were compared mainly with data from the previous 2 years. RESULTS: Compared with 2017, the total number of metabolic and bariatric procedures performed in 2018 increased from approximately 228,000 to 252,000. The sleeve gastrectomy continues to be the most common procedure. The gastric bypass procedure trend remained relatively stable and the gastric band procedure trend continued to decline. The percentage of revision procedures and biliopancreatic diversion with duodenal switch procedures increased slightly. Finally, intragastric balloons placement continues as a significant contributor to the cumulative total number of procedures performed but declined from the previous year. CONCLUSIONS: There was a 10.8% increase in the number of metabolic and bariatric procedures performed in 2018, compared with 2017, with an overall increase of approximately 60% since 2011. When taking into account primary procedures only, approximately 1.1% of patients who qualified for metabolic and bariatric surgery were treated with surgery in 2018.