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Background & Aims: The Orbera intragastric balloon (OIB) is a single fluid-filled intragastric balloon approved for the induction of weight loss and treatment of obesity. However, little is known about the effectiveness and safety of the OIB outside clinical trials, and since approval, the Food and Drug Administration has issued warnings to health care providers about risk of balloon hyperinflation requiring early removal, pancreatitis, and death. We analyzed data on patients who have received the OIB since its approval to determine its safety, effectiveness, and tolerance in real-world clinical settings., Methods: We performed a postregulatory approval study of the safety and efficacy of the OIB, and factors associated with intolerance and response. We collected data from the Mayo Clinic's database of patient demographics, outcomes of OIB placement (weight loss, weight-related comorbidities), technical aspects of insertion and removal, and adverse events associated with the device and/or procedure, from 8 centers (3 academic, 5 private, 4 surgeons, and 4 gastroenterologists). Our final analysis comprised 321 patients (mean age, 48.1 ± 11.9 y; 80% female; baseline body mass index, 37.6 ± 6.9). Exploratory multivariable linear and logistic regression analyses were performed to identify predictors of success and early balloon removal. Primary effectiveness outcomes were percentage of total body weight lost at 3, 6, and 9 months. Primary and secondary safety outcomes were rates of early balloon removal, periprocedural complications, dehydration episodes requiring intravenous infusion, balloon migration, balloon deflation or hyperinflation, pancreatitis, or other complications., Results: Four patients had contraindications for placement at the time of endoscopy. The balloon was safely removed in all instances with an early removal rate (before 6 months) in 16.7% of patients, at a median of 8 weeks after placement (range, 1-6 mo). Use of selective serotonin or serotonin-norepinephrine re-uptake inhibitors at the time of balloon placement was associated with increased odds of removal before 6 months (odds ratio, 3.92; 95% CI, 1.24-12.41). Total body weight lost at 3 months was 8.5% ± 4.9% (n = 204), at 6 months was 11.8% ± 7.5% (n = 199), and at 9 months was 13.3% ± 10% (n = 47). At 6 months, total body weight losses of 5%, 10%, and 15% were achieved by 88%, 62%, and 31% of patients, respectively. Number of follow-up visits and weight loss at 3 months were associated with increased weight loss at 6 months (β = 0.5 and 1.2, respectively) (P < .05). Mean levels of cholesterol, triglycerides, low-density lipoprotein, and hemoglobin A1c, as well as systolic and diastolic blood pressure, were significantly improved at 6 months after OIB placement (P < .05)., Conclusions: In an analysis of a database of patients who received endoscopic placement of the OIB, we found it to be safe, effective at inducing weight loss, and to reduce obesity-related comorbidities in a real-world clinical population. Rates of early removal (before 8 weeks) did not differ significantly between clinical trials and the real-world population, but were affected by use of medications., (Copyright © 2018 AGA Institute. Published by Elsevier Inc. All rights reserved.)

Purpose: Exercise is associated with altered gut microbial composition, but studies have not investigated whether the gut microbiota and associated metabolites are modulated by exercise training in humans. We explored the impact of 6 wk of endurance exercise on the composition, functional capacity, and metabolic output of the gut microbiota in lean and obese adults with multiple-day dietary controls before outcome variable collection., Methods: Thirty-two lean (n = 18 [9 female]) and obese (n = 14 [11 female]), previously sedentary subjects participated in 6 wk of supervised, endurance-based exercise training (3 d·wk) that progressed from 30 to 60 min·d and from moderate (60% of HR reserve) to vigorous intensity (75% HR reserve). Subsequently, participants returned to a sedentary lifestyle activity for a 6-wk washout period. Fecal samples were collected before and after 6 wk of exercise, as well as after the sedentary washout period, with 3-d dietary controls in place before each collection., Results: β-diversity analysis revealed that exercise-induced alterations of the gut microbiota were dependent on obesity status. Exercise increased fecal concentrations of short-chain fatty acids in lean, but not obese, participants. Exercise-induced shifts in metabolic output of the microbiota paralleled changes in bacterial genes and taxa capable of short-chain fatty acid production. Lastly, exercise-induced changes in the microbiota were largely reversed once exercise training ceased., Conclusion: These findings suggest that exercise training induces compositional and functional changes in the human gut microbiota that are dependent on obesity status, independent of diet and contingent on the sustainment of exercise.

Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG) reduce blood pressure (BP) in obese patients with hypertension (HTN). We compared the effect of RYGB and SG on BP in obese patients with HTN at a large-volume, private bariatric surgery center using a propensity score analysis. The measurement and management of BP were exclusively left to the patient's provider without any involvement of Tulane investigators. At month 1, RYGB and SG equally decreased: (1) mean body weight: 12.7 vs 13.2 kg (p=not significant (NS)) (2) systolic/diastolic BP: 8.5/5.3 vs 8.0/4.2 mm Hg (p=NS) and (3) average number of antihypertensive medications from 1.5 to 0.8 and from 1.6 to 0.6 per patient (p=NS). From month 1 to 12, BP remained unchanged after RYGB but tended to increase from month 6 to 12 after SG. Remission of HTN occurred in 52% and 44% of patients after RYGB and SG. In contrast to the full effect of RYGB and SG on BP at 1 month, body weight decreases steadily over 12 months after RYGB and SG. In conclusion, early after surgery, RYGB and SG equally reduce BP in obese patients with HTN. Thereafter, RYGB has a more sustained effect on BP than SG. [ABSTRACT FROM AUTHOR]

Abstract The objective of this study was to determine the effect of laparoscopic sleeve gastrectomy (LSG) on blood pressure in private practice settings. This study involved a retrospective review of 870 consecutive adult patients >18 y of age who underwent LSG over a period of 12 mo in a private bariatric surgery center. Data were collected from the preoperative and postoperative follow-up visits at 1, 3, 6, and 12 mo. The study population consists of 694 hypertensive and 176 normotensive patients. From the baseline to 12 mo after LSG, (1) mean body weight/body mass index decreased from 123 kg/44 kg/m2 to 94 kg/34 kg/m2 (P <.001); (2) mean systolic/diastolic blood pressure in hypertensive patients decreased from 131.9/79.9 to 127.6/77.1 mm Hg (P <.001); 3) only mean systolic blood pressure decreased in normotensive patients from 117.5 to 114.0 mm Hg (P <.001). One month after LSG, mean systolic blood pressure had decreased from 131.9 to 126.2 mm Hg (P < 0. 001) and the average number of antihypertensive medications per patient declined from 1.5 at the baseline to 0.6 (P <.001). Over the following 11 mo, blood pressure remained stable despite reduced antihypertensive therapy. Patients requiring more than two antihypertensive agents fell from 49% at the baseline to 22% at 12 mo. Hypertension resolved in 34% of patients. Linear regression analysis showed no association between change in body weight and change in systolic blood pressure. Within 1 mo of LSG, hypertensive patients experienced a significant decline in systolic blood pressure and antihypertensive therapy that remains unchanged at 12 mo in the face of major reductions in antihypertensive medications. Weight loss and blood pressure reduction may not be directly related. Highlights • Laparoscopic sleeve gastrectomy results in a rapid and sustained decline in systolic blood pressure. • There is a temporal dissociation between the decline in systolic blood pressure and body mass index. • The decline in systolic blood pressure is associated with a major reduction in antihypertensive therapy. [ABSTRACT FROM AUTHOR]

Objective: Bariatric surgery has been shown to be the most effective method of achieving weight loss and alleviating obesity-related comorbidities. Yet, it is not being used equitably. This study seeks to identify if there is a disparity in payer status of patients undergoing bariatric surgery and what factors are associated with this disparity. Methods: We performed a case-control analysis of National Inpatient Sample. We identified adults with body mass index (BMI) greater than or equal to 25 kg/m who underwent bariatric surgery and matched them with overweight inpatient adult controls not undergoing surgery. The sample was analyzed using multivariate logistic regression. Results: We identified 132,342 cases, in which the majority had private insurance (72.8%). Bariatric patients were significantly more likely to be privately insured than any other payer status; Medicare- and Medicaid-covered patients accounted for a low percentage of cases (Medicare 5.1%, OR 0.33, 95% CI 0.29-0.37, p < 0.001; Medicaid 8.7%, OR 0.21, 95% CI 0.18-0.25, p < 0.001). Medicare (OR 1.54, 95% CI 1.33-1.78, p < 0.001) and Medicaid (OR 1.31, 95% CI 1.08-1.60, p = 0.007) patients undergoing bariatric surgery had an increased risk of complications compared to privately insured patients. Conclusions: Publicly insured patients are significantly less likely to undergo bariatric surgery. As a group, these patients experience higher rates of obesity and related complications and thus are most in need of bariatric surgery. [ABSTRACT FROM AUTHOR]

Background: We conducted this study to compare the weight loss outcome of intragastric balloons (IGBs) in conjunction with pharmacotherapy vs IGB and intensive lifestyle changes alone. Methods: This was a multicenter, non-randomized, retrospective study involving 4 academic hospitals. Patients underwent IGB placement with or without concomitant anti-obesity pharmacotherapy. The primary outcome was percent total weight loss (TBWL) after IGB placement at 6 and 12 months. Results: This study included 102 patients, with 23 patients (mean age 46.6 years, 82.6% female) treated with IGB/pharmacotherapy and 79 patients (mean age 46.0 years, 88.6% female) treated with IGB/lifestyle modifications. Patients had a 100% follow-up rate at 6 and 12 months. At 6 months following IGB placement, both groups achieved a similar %TBWL. At 12 months, %TBWL was greater in the IGB/pharmacotherapy group (12.6% ± 1.2 vs 9.7% ± 0.7, P =.04). 65.2% of patients achieved ≥10% TBWL at 12 months in the IGB/pharmacotherapy group, compared to 38.0% in the IGB/lifestyle group (P <.05). The proportion of patients that achieved ≥15% weight loss at 12 months was also significantly different between the IGB/pharmacotherapy and IGB/lifestyle groups (30.4% vs 20.3%, P <.05). Discussion: IGB with concomitant use of pharmacotherapy did not improve weight loss while the IGB was in place compared to IGB and lifestyle changes. However, patients receiving IGB with pharmacotherapy did have greater weight loss and diminished weight regain after balloon removal compared to those receiving just IGB and lifestyle changes. [ABSTRACT FROM AUTHOR]