EndoBarrier treatment for longstanding type 2 diabetes and obesity: outcomes one year after EndoBarrier in 90 consecutively treated patients

Abstract

Aims: EndoBarrier is a 60cm duodenal–jejunal bypass liner endoscopically implanted for up to one year and designed to mimic the by-pass part of Roux-en-Y bariatric surgery. We aimed to assess the safety and efficacy of EndoBarrier in patients with suboptimally-controlled diabesity.

Methods: Between July 2013 and November 2017 we implanted 90 EndoBarriers in a single centre with all removed by November 2018. Outcomes were monitored in a registry.

Results: All 90 patients have completed one-year post EndoBarrier removal and, of these, 71/90 (79%) – age 51.3 ± 8.6 years, 46% male, 52% White ethnicity, diabetes duration 13.0 (7.0–17.0) years, 59% insulin-treated, BMI 41.1 ± 6.5kg/m2) – attended follow-up and 19/90 (21%) did not attend follow-up. During EndoBarrier implantation, mean ± SD HbA1c fell by 19.5 ± 18.4mmol/mol from 78.1 ± 18.9 to 58.6 ± 13.6mmol/mol (p < 0.001), weight by 15.9 ± 8.6kg from 118.4 ± 27.0 to 102.4 ± 27.7kg (p < 0.001), systolic BP from 139.0 ± 15.0mmHg to 126.6 ± 17.6mmHg (p < 0.001), cholesterol from 4.8 ± 1.2 to 4.0 ± 1.0mmol/L (p < 0.001), and serum alanine-aminotransferase (marker of liver fat) from 31.0 ± 16.5 to 19.8 ± 11.5U/L (p < 0.001). Median (IQR) total daily insulin dose reduced from 98 (53–163) to 30 (0–63) units (p < 0.001). Eleven of 42 (26.2%) insulin treated patients discontinued insulin. One year post-EndoBarrier 32/71 (45%) demonstrated fully-sustained improvement, 25/71 (35%) partially-sustained improvement and 14/71 (20%) reverted to baseline. Of those deteriorating, 10/14 (71%) had depression and/or bereavement. Thirteen of 90 (14%) patients required early EndoBarrier removal: five for gastrointestinal haemorrhage, two for liver abscess, one for non-hepatic intra-abdominal abscess, and five for gastrointestinal symptoms. All made a full recovery.

Conclusion: Our data demonstrate EndoBarrier as highly effective in patients with refractory diabesity, with maintenance of significant improvement one year after removal in 80% of cases. As it requires only an endoscopic procedure, EndoBarrier treatment is relatively simple and non-invasive and it deserves further investigation.