Safety and Efficacy of 12-Month Intra-gastric Balloon-Series of over 1100 Patients

Intra-gastric balloons (IGB) are a mainstay of endoscopic treatment of overweight and obesity. In recent years, an IGB which can remain in situ for 12 months has been developed. The current study aimed to analyse the safety and efficacy of this 12-month IGB.

Consecutive patients receiving the Orbera 365^TM IGB (Apollo Endosurgery, TX, USA) between September 2017 and August 2021 were included in a prospective database. Patients received regular follow-up consultations followed by endoscopic removal at 12 months. Demographic data along with weight loss data were collected. All adverse events were recorded.

In total, 1149 patients were included in the study. A majority of the patients were female (87.13%). Median body mass index (BMI) prior to insertion was 36.30 kg/m² (IQR 32.60-40.00 kg/m²). Median absolute weight loss for all patients was 11.36 kg (IQR 6.70-16.82 kg). There was ongoing sustained weight loss until device removal at week 52. For patients with a weight recording at point of IGB removal, median weight loss was greater (15.88 kg, IQR 10.43-21.72) with percentage total body weight loss of 15.38% (IQR 10.99-21.77) and excess weight loss of 53.99% (IQR 32.44-76.30). Increased patient engagement with post-procedural follow-up was associated with increased weight loss (p<0.001). There were 60 total complications (5.22%). Fifty patients required balloon removal due to intolerance. There were eight cases of balloon rupture. There were only two severe complications (0.17%).

The current study has confirmed safety of this IGB at 12 months with adverse events comparable to published literature. Weight loss increased up until the point of removal at 12 months.