Technique or technology? Evaluating leaks after gastric bypass.

OBJECTIVE: To assess the relationship between technique and surgical devices on anastomotic and staple-line leaks after laparoscopic Roux-en-Y gastric bypass. BACKGROUND: Leaks after bariatric surgery remain a major source of morbidity and mortality. The association of surgical technique and devices with leaks after gastric bypass is poorly understood. SETTING: Multi-centered study that included teaching and non-teaching hospitals that participate in a statewide consortium for quality improvement using a payer-funded outcome registry. METHODS: We analyzed data from the Michigan Bariatric Surgery Collaborative and performed a case-control study comparing patients who sustained a leak with those who did not after primary laparoscopic Roux-en-Y gastric bypass. A total of 71 (.44%) patients with leaks were identified between January 2007 and December 2011. The leak group was matched 1:2 to a control group (nonleak) based on procedure type, age, body mass index, sex, and the year in which the procedure was performed. Technique-specific case characteristics and device-specific factors were assessed by reviewing operative notes from all primary bariatric procedures in our study population. RESULTS: The rate of leak decreased during the study period, and there was a significant downward trend (slope estimate: -.19961%, P = .0372). After performing multivariate analysis, the type of anastomosis (circular stapler, hand-sewn, or linear stapler) and stapler manufacturer were not associated with leaks. The use of buttressing material was associated with a higher rate of leaks (odds ratio: 8.79 [95% confidence interval: 2.49-31.01], P = .0007), whereas the use of fibrin sealant was associated with a lower rate of leaks (odds ratio .11 [95% confidence interval: .03-.41], P = .0013). These findings could not be explained by differences in measures of surgeon performance. CONCLUSION: Leak rates after laparoscopic gastric bypass have fallen in Michigan despite variations in technique and device utilization. Although the type of anastomosis and stapler manufacturer do not appear to be significantly associated with leaks, it appears that the use of buttressing material was more common in cases in which leaks occurred, whereas the use of fibrin sealant was not. Given the complex interplay of multiple variables that affect surgical outcomes, future studies justifying the benefits of operative devices should be evaluated prospectively in the context of surgeon technique and skill.

Clinical outcomes of the Realize Adjustable Gastric Band-C at 2 years in a United States population.

BACKGROUND: In 2008, the Realize Band (RB) adopted a precurved design (RB-C). We present 2-year outcomes data from the first multiinstitutional study of RB-C. The objective of this study was to analyze weight loss and safety data from bariatric practices in the United States, including academic, nonacademic, public, and private. METHODS: The study included adult RB-C patients with a preoperative body mass index (BMI)≥40 kg/m(2) or >35 kg/m(2) with co-morbidity. Exclusions included RB-C's label contraindications for use. Outcomes parameters were percent excess weight loss (%EWL), BMI change, number and volume of band adjustments, and adverse events. RESULTS: A total of 231 patients met inclusion/exclusion criteria. Of these, 161 had 24-month data available. Mean %EWL was 44.4%±26.9% (P<.0001). BMI decreased from 44.1±5.7 kg/m(2) to 35.3±6.9 kg/m(2) (P<.0001). Percent EWL varied by preoperative BMI (P = .0002), bariatric practice (P<.0001), aftercare frequency (P = .0004), and band fill frequency (P = .0271), but %EWL was not influenced by gender, race, or age (P>.20 each). Adverse events were dysphagia (21.2%), gastroesophageal reflux (21.6%), and vomiting (30.7%). Incidence of pouch dilation, esophageal dilation, and slippage was ≤1%. Revisions (2.2%) were for unbuckled band, tube kinking, slippage, and suspected band leak (1 each). No erosions, explants, or mortality were reported. CONCLUSION: RB-C appears to be as well tolerated and effective as the first generation RB for weight loss. The near 45% EWL at 2 years is consistent with other high-quality publications on the RB. Preoperative BMI and frequency of postoperative care, including frequency of band fills, influence %EWL. Significant weight loss is achievable with RB-C despite variable postoperative management practices. The low morbidity and the absence of mortality at 24 months reflect positively on the RB-C characteristics.

The comparative effectiveness of sleeve gastrectomy, gastric bypass, and adjustable gastric banding procedures for the treatment of morbid obesity.

OBJECTIVE: To evaluate the comparative effectiveness of sleeve gastrectomy (SG), laparoscopic gastric bypass (RYGB), and laparoscopic adjustable gastric banding (LAGB) procedures. BACKGROUND: Citing limitations of published studies, payers have been reluctant to provide routine coverage for SG for the treatment of morbid obesity. METHODS: Using data from an externally audited, statewide clinical registry, we matched 2949 SG patients with equal numbers of RYGB and LAGB patients on 23 baseline characteristics. Outcomes assessed included complications occurring within 30 days, and weight loss, quality of life, and comorbidity remission at 1, 2, and 3 years after bariatric surgery. RESULTS: Matching resulted in cohorts of SG, RYGB, and LAGB patients that were well balanced on baseline characteristics. Overall complication rates among patients undergoing SG (6.3%) were significantly lower than for RYGB (10.0%, P < 0.0001) but higher than for LAGB (2.4%, P < 0.0001). Serious complication rates were similar for SG (2.4%) and RYGB (2.5%, P = 0.736) but higher than for LAGB (1.0%, P < 0.0001). Excess body weight loss at 1 year was 13% lower for SG (60%) than for RYGB (69%, P < 0.0001), but was 77% higher for SG than for LAGB (34%, P < 0.0001). SG was similarly closer to RYGB than LAGB with regard to remission of obesity-related comorbidities. CONCLUSIONS: With better weight loss than LAGB and lower complication rates than RYGB, SG is a reasonable choice for the treatment of morbid obesity and should be covered by both public and private payers.

Comparative effectiveness of unfractionated and low-molecular-weight heparin for prevention of venous thromboembolism following bariatric surgery.

OBJECTIVE: To evaluate the effectiveness and safety of 3 predominant venous thromboembolism (VTE) prophylaxis strategies among patients undergoing bariatric surgery. DESIGN: Cohort study. SETTING: The Michigan Bariatric Surgery Collaborative, a statewide clinical registry and quality improvement program. PATIENTS: Twenty-four thousand seven hundred seventy-seven patients undergoing bariatric surgery between 2007 and 2012. INTERVENTIONS: Unfractionated heparin preoperatively and postoperatively (UF/UF), UF heparin preoperatively and low-molecular-weight heparin postoperatively (UF/LMW), and LMW heparin preoperatively and postoperatively (LMW/LMW). MAIN OUTCOME MEASURES: Rates of VTE, hemorrhage, and serious hemorrhage (requiring >4 U of blood products or reoperation) occurring within 30 days of surgery. RESULTS: Overall, adjusted rates of VTE were significantly lower for the LMW/LMW (0.25%; P < .001) and UF/LMW (0.29%; P = .03) treatment groups compared with the UF/UF group (0.68%). While UF/LMW (0.22%; P = .006) and LMW/LMW (0.21%; P < .001) were similarly effective in patients at low risk of VTE (predicted risk <1%), LMW/LMW (1.46%; P = .10) seemed more effective than UF/LMW (2.36%; P = .90) for high-risk (predicted risk ≥1%) patients. There were no significant differences in rates of hemorrhage or serious hemorrhage among the treatment strategies. CONCLUSION: Low-molecular-weight heparin is more effective than UF heparin for the prevention of postoperative VTE among patients undergoing bariatric surgery and does not increase rates of bleeding.

Clinical outcomes of the REALIZE adjustable gastric band-C at one year in a U.S. population.

BACKGROUND: In 2008, the REALIZE Band (RB) adopted a precurved design (RB-C). The present study is the first multi-institutional report of RB-C outcomes. Our objective was to analyze the 1-year weight loss and safety data from adult RB-C patients treated at multiple U.S. centers (7 typical U.S. bariatric practices, including academic, nonacademic, public, and private practice). METHODS: Patients implanted with the RB-C (preoperative body mass index ≥ 40 kg/m(2) or >35 kg/m(2) with co-morbidity) were recruited. The exclusion criteria included the RB-C label contraindications for use. The outcomes parameters were the percentage of excess weight loss (%EWL), change in body mass index, number and volume of band adjustments, and incidence of complications. RESULTS: Of the 239 patients enrolled in the 2-year study, 158 had 1-year data available for analysis in November 2010. The mean %EWL was 39.2% ± 20.5% (range -7.7 to -116.8, P < .0001). The body mass index decreased from 44.4 ± 5.5 kg/m(2) to 36.4 ± 5.8 kg/m(2) (P < .0001). The variability in the %EWL was significant among the study centers (P < .0001). The average band fill volume at 1 year was 8.0 ± 2.0 mL (range .0-11.1). The total fill volume was >11 mL in 1 patient. No band erosions/migrations, explants, or deaths occurred. CONCLUSION: RB-C appears to be as safe and effective as the first-generation RB. The near 40% EWL at 1 year was consistent with other high-quality publications of the RB. Good weight loss results are achievable, despite the varying postoperative management practices. The low morbidity and the absence of mortality at 12 months reflect positively on the RB-C characteristics. Our findings suggest that the learning curve, related to the postoperative management of the RB-C, might vary by practice and that a greater frequency and smaller band fills might result in better weight loss at 12 months.