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.

Laparoscopic sleeve gastrectomy as a viable option for an ambulatory surgical procedure: our 52-month experience.

BACKGROUND: We present our experience with same-day discharge (without an overnight stay) after laparoscopic sleeve gastrectomy (SG) in 821 consecutive patients from 2011 to 2015. This is the largest series published to date of patients undergoing ambulatory surgery for such a procedure. OBJECTIVES: To review our outcomes from ambulatory SG over 52 months to determine if SG can be safely performed in the ambulatory setting. SETTING: Ambulatory surgery center. METHODS: Retrospective review of all consecutive patients undergoing ambulatory SG from January 2011 to April 2015. All patients were discharged home the same day after surgery without an overnight stay at the hospital. Incidence of complications and admission to the hospital after discharge was reviewed up to 30 days from surgery. RESULTS: From January 2011 to April 2015, 821 consecutive patients underwent SG. Nineteen 30-day complications occurred in the series, 17 of them requiring admission to the hospital. Of the 19 cases, gastric leaks accounted for 7, intr-aabdominal abscess for 4, and dehydration/nausea/vomiting for 4; 4 were due to other causes. Complication and readmission rates at 30 days were 2.3% and 2.1%, respectively. Follow-up at 30 days was 98.4%. CONCLUSION: With stringent patient selection and utilization of enhanced recovery pathways, our study indicates that SG may be suitable for the outpatient setting. Experience and comfort with bariatric surgery is essential on the part of the operating surgeon to ensure good outcomes. Our low overall readmission and complication rate portends to the feasibility of laparoscopic SG as a safe outpatient procedure.

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.

Health Outcomes and Explant Rates After Laparoscopic Adjustable Gastric Banding: A Phase 4, Multicenter Study over 5 Years.

OBJECTIVE: This study aimed to evaluate the real-world safety and effectiveness of the LAP-BAND (Apollo Endosurgery Inc., Austin, Texas) adjustable gastric banding system (LBS) for 5 years following implantation. METHODS: This prospective, longitudinal, phase 4, multicenter study involved 652 patients who had implantation of the LBS system. The primary outcome was the percentage of subjects who had LBS explant over 5 years. The secondary outcomes included the rate of reoperations, clinical and biochemical measures, and patient-reported outcome measures over 5 years. RESULTS: The study cohort consisted of 79.3% females with a mean age of 44 years and a mean BMI of 45.4 kg/m2 . The primary end point was met with an explant rate of 8.74% (95% CI: 6.6%-10.9%) at 5 years. The rates for completer-only analysis and imputed missing data analysis were 12.81% (95% CI: 9.7%-15.9%) and 12.85% (95% CI: 10.2%-15.5%), respectively. All were significantly lower than the historic rate of 39.4% (P < 0.001). There were 43 patients who required reoperations or revisions excluding explants (6.6%). A mean weight loss of 18.7% was maximally achieved by 2 years, and weight loss was maintained through to 5 years. All patient-reported outcomes showed improvement following LBS treatment throughout 5 years. CONCLUSIONS: This study validates the long-term safety and effectiveness of LBS for the treatment of patients with obesity and its related conditions.

Comparing outcomes of hand-assisted versus total laparoscopic gastric bypass.

BACKGROUND: Previous studies have compared open versus hand-assisted and open versus total laparoscopic Roux-en-Y gastric bypass. This study compared hand-assisted and total laparoscopic Roux-en-Y gastric bypass surgery performed at 2 institutions by 2 surgeons, each specializing in 1 of the techniques. METHODS: Gastric bypass operations (n = 272) were evaluated from January 1, 2004 to December 31, 2004. The comparisons between the hand-assisted (n = 149) and laparoscopic (n = 123) approach were done using the median test, t test, chi-square analysis, and Fisher's exact test. RESULTS: The average patient age was 43.9 years, and 84% (229 of 272) of the patients were women. The average body mass index was 48.8 kg/m2. No significant difference was found between the hand-assist and laparoscopic groups in age, gender, preoperative body mass index, diabetes, hypertension, or operative time. No significant difference was found in the mortality rate between the hand-assist (2 of 149, 1.3%) and laparoscopic (1 of 123, 0.8%) groups. Also, no significant difference was found in the incidence of leaks, pulmonary embolism, deep venous thrombosis, wound infection, bowel obstruction, incisional hernia, fistula, persistent vomiting, or reoperation between the 2 procedures. A significant difference was found in the length of stay, with a median of 3 days for the hand-assist group and 2 days for the laparoscopic group (P <.001), and hemorrhage requiring transfusion, which occurred in 1 (.7%) of 149 hand-assist patients and 7 (5.7%) of 123 laparoscopic patients (P = .025). The percentage of excess weight loss 6 months after surgery was also similar between the two groups, at 50.2% and 52.1% for the hand-assist and laparoscopic groups, respectively (P = .45). CONCLUSIONS: The results of this study have found that both hand-assist and laparoscopic Roux-en-Y gastric bypass can be accomplished with similar perioperative risks and outcomes, including weight reduction. The choice between the 2 procedures depends on surgeon preference.