Weight Loss Maintenance 1 Year after the Swallowable Gastric Balloon: Results from an International Multicenter Study.

BACKGROUND

The Allurion Swallowable Gastric Balloon Program (SGBP) is a non-endoscopic balloon and behavior change program for weight loss that provides remote patient monitoring, secure messaging, and telehealth via a Bluetooth-connected scale and mobile app. This study aimed to evaluate the effectiveness of the SGBP 1 year after the gastric balloon naturally exits the body, which typically happens around 4 months after balloon placement.

METHODS

Patients (≥ 16 years) were followed every 2 weeks during balloon residency and then monthly for 1 year after balloon passage. Weight loss (WL), total body weight loss (%TBWL), and body mass index loss (BMIL) were retrospectively analyzed from nine international obesity centers.

RESULTS

Follow-up data were available for 522 patients (331 females, 191 males), from a database of 3716 patients, mean age 43.5 years. Mean ± SD weight and BMI before the procedure were 101.9 ± 21.2 kg and 35.9 ± 5.8 kg/m2. After 4 months of treatment, WL, %TBWL, and BMIL were 14.4 ± 7.7 kg, 13.9 ± 6.3%, and 5.1 ± 2.6 kg/m2 respectively (all p < 0.0001). One year after balloon passage, WL, %TBWL, and BMIL were 13.9 ± 11.6 kg, 13.2 ± 9.9%, and 4.9 ± 3.9 kg/m2 respectively (all p < 0.0001). The %TBWL maintenance 1 year after balloon passage was 95%. Adverse events observed were intolerance requiring balloon removal (1.2%), gastric dilation (0.2%), gastritis (0.2%), and gastric perforation requiring laparoscopic repair (0.2%). Seven patients (1.3%) passed the empty balloon by vomiting at the end of balloon residence without any other side effects.

CONCLUSIONS

The SGBP demonstrated significant four-month weight loss and weight loss maintenance 1 year after balloon passage. Close communication using a Bluetooth-connected scale and mobile app allowed for virtual follow-up during treatment and after balloon passage, and also provides a platform for follow-up after other treatments, such as surgical and medical weight loss interventions.