Faculty Bibliography

BACKGROUND:Extended-course enoxaparin is increasingly used after bariatric surgery to prevent venous thromboembolism (VTE), the leading cause of death after bariatric surgery. Direct oral anticoagulants are widely used for extended thromboprophylaxis outside of bariatric surgery and offered to patients in our program who cannot tolerate or obtain enoxaparin. We evaluated the safety and efficacy of apixaban 2.5 mg twice daily relative to a weight-based dose of enoxaparin 40 mg or 60 mg twice daily for 30 days after discharge following sleeve gastrectomy. METHODS:Patients aged ≥18 years who underwent laparoscopic sleeve gastrectomy from 2019 to 2024 at a single high-volume urban academic center were included. Bleeding and thrombosis outcomes within 30 days were compared between patients receiving enoxaparin 40 mg twice daily or apixaban 2.5 mg twice daily. Weighted modified Poisson analyses were used to obtain covariate balance and assess differences in bleeding and thrombosis events. RESULTS:A total of 5921 patients were included for analysis (5274 enoxaparin 40 mg twice daily, 486 enoxaparin 60 mg twice daily, and 161 apixaban 2.5 mg twice daily). The 30-day thrombosis rate was significantly lower with enoxaparin versus apixaban (.1% versus 1.9%, P < .001). The composite outcome (VTE, portomesenteric venous thrombosis, and major/minor bleeding) was also significantly lower with enoxaparin versus apixaban (1.7% versus 5.6%, P < .01). In adjusted analyses, apixaban was associated with a relative risk of 12.09 for thrombosis (95% confidence interval [CI], 5.71-31.18), 1.93 for bleeding (95% CI, 1.27-3.00), and 2.59 (95% CI, 2.06-3.27) for any adverse outcome relative to enoxaparin. CONCLUSION/CONCLUSIONS:Enoxaparin is associated with both lower thrombosis and bleeding rates compared with apixaban for extended thromboprophylaxis after sleeve gastrectomy.

OBJECTIVE:Given frailty and comorbidities that occur with both aging and end-stage kidney disease (ESKD), it is unclear if older patients with ESKD derive the improved survival and kidney transplant (KT) access associated with Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy (SG). METHODS:Using 2006-2021 USRDS data, we identified 876 patients with RYGB and 1508 patients with SG and compared 5-year mortality by age-group (18-29/30-39/40-49/50-59/60-69/≥ 70 years) to nonsurgical matched controls using 1:3 Mahalanobis distance matching, Kaplan-Meier, and Cox regression. We also compared age-stratified KT incidence between waitlisted patients and controls. RESULTS:) for patients with SG versus controls. CONCLUSIONS:RYGB in older patients with ESKD is associated with increased mortality and lower KT likelihood, whereas SG is associated with decreased mortality and higher KT likelihood compared to nonsurgical matched controls. Choice of bariatric surgery type may play a role in improving survival for older patients with ESKD.

INTRODUCTION/BACKGROUND:Robotic sleeve gastrectomy (RSG) is increasingly used in bariatric surgery, but its safety compared to laparoscopic sleeve gastrectomy (LSG) remains debated. METHODS:We retrospectively reviewed electronic medical records of 927 (575 RSG, 352 LSG) patients at a single academic center from June 2021 to August 2023. The baseline and operative characteristics of the study groups were compared using two-sample t tests, Wilcoxon rank-sum tests, chi-square tests, and Fisher's exact tests. Thirty-day complication rates were compared using multiple logistic regression, adjusted for baseline factors, operative characteristics, ASA class, and staple-line reinforcement. Statistical analysis was conducted using SAS 9.4, and p-values < 0.05 were considered significant. Logistic regression was used to evaluate whether complication rates were different between RSG and LSG while adjusting for other factors. RESULTS:(RSG 43, LSG 43.12, p = 0.806), average age 39.8 (RSG 39.3, LSG 40.7, p = 0.084), and 74% were females (RSG 75%, LSG 69.8%, p = 0.032). Baseline characteristics were comparable between the two groups. Median operative time was 73 min for RSG vs 66 min for LSF (p = 0.0002). Thirty-day complication rates were 3.5% in both groups (adjusted OR = 1.00, 95% CI 0.43-2.35, p = 0.998). Quarterly analysis and CUSUM demonstrated no residual learning-curve effect on complications. Power analysis confirmed ≥ 80% power to detect a ≥ 5% absolute difference. Missing-data sensitivity analyses corroborated primary findings. CONCLUSIONS:RSG is as safe as LSG within 30 days, with a modest 7-min operative-time penalty that is unlikely to be clinically meaningful.

INTRODUCTION/BACKGROUND:GLP-1 receptor agonists (GLP1-RAs) are increasingly prescribed as an alternative to bariatric surgery for weight loss, and may pose as an alternative to conversion Roux-En-Y Gastric Bypass (cRYGB) in patients with insufficient weight loss or weight recurrence after sleeve gastrectomy [A C, N C, A I. Postoperative morbidity and weight loss after revisional bariatric surgery for primary failed restrictive procedure: a systematic review and network meta-analysis. International Journal of Surgery; 2022;Jensen et al. in Obes Surg 33:1017-1025, 2023; Jamal et al. in Obes Surg 34:1324-1332, 2024; Lautenbach A, Wernecke M, Stoll FD, Meyhöfer SM, Meyhöfer S, Aberel J. 1422-P: The potential of semaglutide once-weekly in patients without Type 2 Diabetes with weight regain or insufficient weight loss after bariatric surgery. Diabetes 2022; 71(Supplement_1);]. METHODS AND PROCEDURES/METHODS:Adult patients ≥ 18 years old, who previously underwent a sleeve gastrectomy and were subsequently treated with weekly injectable Semaglutide or Tirzepatide, or treated with conversion from sleeve gastrectomy were included for analysis. Patients converted for GERD, GLP1-RA use with BMI ≤ 35, or pre operative GLP1-RA use were excluded. Post operative weights and Hgb A1C were assessed from 3 months to 3 years post intervention (start of GLP1-RA or surgery). T-test, ANOVA, and chi-squared analysis were used to compare groups, while multivariable linear regression analysis was used to evaluate the effect of bariatric surgery on %TBWL at 3 years post intervention when adjusting for baseline characteristics. RESULTS:4901 patients were included for analysis (3004 cRYGB, 1897 GLP1-RA). There was no difference in pre-intervention weight (242.8 ± 44.4 GLP1-RA vs 242.3 ± 57.8 cRYGB, p = .993). cRYGB patients had a higher baseline Hgba1c (6.19 ± 1.4 vs 5.85 ± 1.2, p < 0.001). cRYGB was associated with significantly greater weight loss at all post operative time points up to 3 years post intervention, (26.1 vs 13.7%, p < 0.001). There was no significant difference in Hgba1c control between treatments at all post intervention time points (all p > 0.05). In the multivariate linear regression analysis, when adjusting for sex, baseline BMI, baseline age, and non-white race, cRYGB was associated with an 11% greater %TBWL compared to those who were treated with a GLP1-RA. CONCLUSIONS:For patients who have had insufficient weight loss or weight recurrence following sleeve gastrectomy, conversion to RYGB offers greater, long-term weight loss compared to GLP1-RAs.

OBJECTIVE:This study examined racial and ethnic differences in percent total weight loss (%TWL) and glycemic improvement following sleeve gastrectomy (SG) and explored the role of socioeconomic and psychosocial factors in postsurgical outcomes. METHODS:This longitudinal study included patients who underwent SG between 2017 and 2020, with follow-up visits over 24 months. RESULTS:Non-Hispanic Black (NHB) participants had lower %TWL at 3, 12, and 24 months compared with Hispanic (H) and non-Hispanic White (NHW) participants. Fat mass index was initially lower in NHB, with smaller reductions over time and significant group differences persisting at 24 months. NHB participants had higher baseline fat-free mass index values; by 24 months, fat-free mass index values were lower in H participants. Hemoglobin A1c decreased across all groups but remained consistently higher in NHB and H compared with NHW at 24 months. NHB participants reported higher perceived discrimination, sleep disturbance, and perceived stress than H and NHW participants at all time points. Employment status predicted %TWL at 12 months. There was a significant interaction between race and ethnicity and employment status observed at 12 and 24 months, suggesting that employment-related disparities could impact surgical outcomes. CONCLUSIONS:NHB participants experienced less favorable outcomes following SG, emphasizing the need for tailored interventions addressing socioeconomic and psychosocial disparities.

BACKGROUND:Given the cardiovascular, renal, and survival benefits of GLP-1 receptor agonists for diabetes, these agents could be effective among kidney transplant recipients. However, kidney transplant recipients are distinct from GLP-1 receptor agonist trial participants, with longer diabetes duration and severity, greater end-organ damage, increased cardiovascular risk, and multimorbidity. We examined GLP-1 receptor agonist real-world effectiveness and safety in kidney transplant recipients with diabetes. METHODS:This USA-based retrospective cohort study included kidney transplant recipients with type 2 diabetes at transplantation and Medicare as their primary insurance from a national registry linked with Medicare claims. Post-transplantation GLP-1 receptor agonist use was identified through Medicare claims. Death-censored graft loss was estimated using the Fine-Gray sub-distribution hazard model and extended Cox models were used for mortality and safety endpoints. Models incorporated inverse probability of treatment weights. To further test whether bias could affect the main results, a cohort was created in which each GLP-1 receptor agonist user was matched with a kidney transplant recipient who had not started a GLP-1 receptor agonist, was alive with a functioning graft, and had accrued the same amount of post-transplant survival time. FINDINGS/RESULTS:Between Jan 1, 2013 and Dec 31, 2020, we identified 44 536 first time kidney transplant recipients with Medicare as primary payer in the 6 months before and at transplantation. 24 192 patients were excluded as they did not have type 2 diabetes. 2328 patients were ineligible (1916 had missing values and 412 used GLP-1 receptor agonists before transplantation). The primary cohort thus consisted of 18 016 kidney transplant recipients with diabetes. Of these patients, 1969 (10·9%) had at least one GLP-1 receptor agonist prescription filled post-transplant. Compared with patients who had not received a GLP-1 receptor agonist, GLP-1 receptor agonist users were younger (median age at transplant 57 years [IQR 49-64] vs 60 years [51-66], p<0·0001) and more likely to be female (786 [39·9%] vs 5645 [35·2%], p<0·0001). Among GLP-1 receptor agonist users, 552 [28·0%] were non-Hispanic White, 703 [35·7%] were non-Hispanic Black, and 568 [28·8%] were Hispanic. The 5-year unadjusted cumulative incidence of death-censored graft loss from a cohort matched on survival time before GLP-1 receptor agonist initiation was 6·0% for GLP-1 receptor agonist users and 10·7% for non-users (Gray's test p=0·004). The 5-year unadjusted cumulative incidence for mortality from a cohort matched on survival time before GLP-1 receptor agonist initiation was 17·0% for GLP-1 receptor agonist users and 25·8% for non-users (log-rank p=0·0006). The 5-year unadjusted cumulative incidence for mortality was 13·5% for GLP-1 receptor agonist users and 19·9% for non-users (log-rank p<0·0001). GLP-1 receptor agonist use was associated with a 49% lower incidence of death-censored graft loss (adjusted subhazard ratio [aSHR] 0·51, 95% CI 0·36-0·71; p=0·0001) and 31% lower mortality (adjusted hazard ratio [aHR] 0·69, 95% CI 0·55-0·86; p=0·001). Inferences were robust when matched on survival time (death-censored graft loss aSHR 0·53, 95% CI 0·37-0·75; p=0·0005; mortality aHR 0·70, 95% CI 0·55-0·88; p=0·003). Safety endpoints were rare and not associated with GLP-1 receptor agonists, with the exception of diabetic retinopathy (aHR 1·49, 1·11-2·00; p=0·008). INTERPRETATION/CONCLUSIONS:GLP-1 receptor agonists were associated with better graft and patient survival. Clinical trials are needed to confirm these findings. FUNDING/BACKGROUND:National Institutes of Health.

BACKGROUND:Bariatric surgery, such as Roux-en-Y gastric bypass (RYGB) remains the gold standard for treating obesity. Most people regain weight from postsurgery nadir. OBJECTIVES/OBJECTIVE:Liraglutide 3.0 mg is approved for weight management. This study will examine the effects on liraglutide 3.0 mg on weight regain post-RYGB. SETTING/METHODS:University Hospital, United States. METHODS:A 56-week, double-blind, placebo-controlled study was conducted in 132 subjects, who achieved ≥25% total body weight loss (TBWL) status-post-RYGB and regained ≥10% TBWL after reaching nadir weight (NW). Subjects 18-120 months post-RYGB were randomized to receive liraglutide 3.0 mg/d (n = 89) or placebo (n = 43) with lifestyle counseling regularly for 56 weeks. The co-primary endpoints were the proportion of subjects losing at least 5%, 10%, and 15% TBWL and achieving weight lower than their NW. RESULTS:53.4% of the placebo group and 65% of the liraglutide group completed the trial due to Severe acute respiratory syndrome coronavirus 2 pandemic. The change in %TBWL from baseline to 56-weeks was -8.8 (8.5, -29.2 to 9.7) and 1.1 (3.5, -7.9 to 5.99) in the liraglutide and placebo groups, respectively. 76% and 17% of subjects achieved ≥5% TBWL at 56 weeks in the liraglutide and placebo groups, respectively; 51% and 26.0% of the liraglutide group achieved ≥10% and ≥15% TBWL, respectively. None of the placebo group lost ≥10% TBWL. Twenty-one percent of subjects receiving liraglutide surpassed postoperative NW. No subjects on placebo met this goal. Nonserious adverse events occurred in 41.6% of subjects on liraglutide. Serious adverse events (SAE) occurred less often on liraglutide. CONCLUSIONS:Liraglutide was significantly more effective than placebo in treating weight regain that occurs post-RYGB without increased SAE.

PURPOSE/OBJECTIVE:We developed a comprehensive sleeve gastrectomy (SG) weight loss study cohort and biorepository to uncover mechanisms, biomarkers and predictive factors of weight loss, weight maintenance and amelioration of obesity-related comorbidities. For this purpose, we collected psychosocial, anthropometric, clinical data and a variety of samples pre-surgery, intraoperatively and 1.5, 3, 12 and 24 months post-surgery. For longer-term assessment, the collection of psychosocial and anthropometric data was extended to 10 years. Here, we present in-depth characterisation of the cohort and detailed overview of study procedures as a foundation for future analyses. PARTICIPANTS/METHODS:We consented 647 participants between June 2017 and March 2020 from two bariatric surgery clinics in New York City-one major urban hospital and one private hospital. Of 355 participants who provided baseline data, 300 underwent SG. Of these, 79% are females with an average age of 38 years, 68% are Hispanic, 20% are non-Hispanic Black and 11% are non-Hispanic White. FINDINGS TO DATE/RESULTS:We collected intraoperative adipose and stomach tissues from 282 patients and biosamples (blood, urine, saliva, stool) from 245 patients at 1.5 months, 238 at 3 month, 218 at 12 months and 180 at 24 months post-surgery. We are currently collecting anthropometric and psychosocial data annually until 10 years post-surgery. Data analysis is currently underway. FUTURE PLANS/UNASSIGNED:Our future research will explore the variability in weight loss outcomes observed in our cohort, particularly among Black and Hispanic patients in comparison to their White counterparts. We will identify social determinants of health, metabolic factors and other variables that may predict weight loss success, weight maintenance and remission of obesity-related comorbidities. Additionally, we plan to leverage our biorepository for collaborative research studies. We will complete long-term follow-up data by December 2031. We plan to apply for funding to expand biosample collection through year 10 to provide insights into the mechanisms of long-term weight maintenance.

OBJECTIVES/OBJECTIVE:Obesogenic medications are a putative contributor to the obesity epidemic. While 20% of adults take ≥1 obesogenic medication, the proportion in the end-stage kidney disease (ESKD) population-a group enriched for cardiometabolic complications-is unknown. Obesogenic medications may contribute to obesity and hamper weight loss efforts to achieve transplant listing. METHODS:Using 2017-2020 USRDS and Medicare claims, patients were identified as taking obesogenic medications if prescribed anticonvulsants, antidepressants, antidiabetics, anti-inflammatories, antipsychotics, and/or antihypertensives known to cause weight gain for ≥30 days in their first hemodialysis year. Ordinal logistic and Cox regression with inverse probability of treatment weighting were used to quantify obesogenic medications' association with body mass index (BMI) and listing, respectively. RESULTS:Among 271 401 hemodialysis initiates, 63.5% took ≥1 obesogenic medication. For those in underweight, normal weight, overweight, and class I, II, and III categories, 54.3%, 58.4%, 63.1%, 66.5%, 68.6%, and 68.8% took ≥1, respectively. Number of obesogenic medications was associated with increased BMI; use of one was associated with 13% increased odds of higher BMI (aOR [adjusted odds ratio] 1.14; 95%CI: 1.13-1.16; p < 0.001), use of three was associated with a 55% increase (aOR 1.55; 95%CI: 1.53-1.57; p < 0.001). Any use was associated with 6% lower odds of transplant listing (aHR [adjusted hazard ratio] 0.94; 95%CI: 0.92-0.96; p < 0.001). Within each BMI category, obesogenic medication use was associated with lower listing likelihood. CONCLUSIONS:Obesogenic medication use is common in ESKD patients-particularly those with obesity-and is associated with lower listing likelihood. Whenever possible, non-obesogenic alternatives should be chosen for ESKD patients attempting weight loss to achieve transplant listing.