Effectiveness of Online Aftercare Programs Following Intragastric Balloon Placement for Obesity Is Similar to Traditional Follow-up: a Large Propensity Matched US Multicenter Study.

BACKGROUND: The combination of intragastric balloons (IGB) with comprehensive lifestyle and behavioral changes is critical for ongoing weight loss. Many community and rural practices do not have access to robust obesity resources, limiting the use of IGBs. Online aftercare programs were developed in response to this need, delivering lifestyle coaching to maximize effectiveness. How these programs compare to traditional follow-up is currently unknown. METHODS: Using propensity scoring (PS) methods, two large prospective databases of patients undergoing IGB therapy were compared to estimate the difference in percent total body weight loss (%TBWL) between groups while identifying predictors of response. RESULTS: Seven hundred fifty-eight unique patients across 78 different participating practices (online n = 437; clinical registry n = 321) was analyzed. The mean %TBWL at balloon removal was 11% ± 6.9 with an estimated treatment difference (ETD) between online and traditional follow-up of - 1.5% TBWL (95% CI - 3-0.4%; p = 0.125). Three months post-balloon removal, the combined %TBWL was 12.2% ± 8.3 with an ETD of only 1% TBWL (95%CI - 3-3%; p = 0.08). On multivariable linear regression, each incremental follow-up was associated with increased %TBWL (ß = 0.6% p = 0.002). CONCLUSION: Online IGB aftercare programs provide similar weight loss compared with traditional programs. Increased lifestyle coaching whether in person or remotely is associated with more %TBWL at removal and during follow-up. Close follow-up for clinical symptoms is still warranted.

Single Fluid-Filled Intragastric Balloon Safe and Effective for Inducing Weight Loss in a Real-World Population.

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 (ß = 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.

Preoperative placement of inferior vena cava filters and outcomes after gastric bypass surgery.

OBJECTIVE: To assess relationships between inferior vena cava (IVC) filter placement and complications within 30 days of gastric bypass surgery. SUMMARY OF BACKGROUND DATA: IVC filters are increasingly being used as prophylaxis against postoperative pulmonary embolism in patients undergoing bariatric surgery, despite a lack of evidence of effectiveness. METHODS: On the basis of data from a prospective clinical registry involving 20 Michigan hospitals, we identified 6376 patients undergoing gastric bypass surgery between 2006 and 2008. We then assessed relationships between IVC filter placement and complications within 30 days of surgery. We used propensity scores and fixed effects logistic regression to control for potential selection bias. RESULTS: A total of 542 gastric bypass patients (8.5%) underwent preoperative IVC filter placement, most of whom (65%) had no history of venous thromboembolism. The use of IVC filters for gastric bypass patients varied widely across hospitals (range, 0%-34%). IVC filter patients did not have reduced rates of postoperative venous thromboembolism (adjusted odds ratio [OR], = 1.28; 95% confidence interval [CI], 0.51-3.21), serious complications (adjusted OR, = 1.40; 95% CI, 0.91-2.16), or death/permanent disability (adjusted OR, = 2.49; 95% CI, 0.99-6.26). More than half (57%) of the IVC filter patients in the latter group had a fatal pulmonary embolism or complications directly related to the IVC filter itself, including filter migration or thrombosis of the vena cava. In subgroup analyses, we were unable to identify any patient group for whom IVC filters were associated with improved outcomes. CONCLUSIONS: Prophylactic IVC filters for gastric bypass surgery do not reduce the risk of pulmonary embolism and may lead to additional complications.