The United Kingdom's first NHS Endobarrier service for advanced diabesity: 1-year outcomes for all 62 treated patients

Robert EJ Ryder, Susan P Irwin, Wyn Burbridge, Hardeep Gandhi, Tahira Bashir, Rachael A Allden, Mordel Wilson, Melanie Wyres, Melissa Cull, Mahi Yadagiri, John P Bleasdale, Edward N Fogden, Mark R Anderson, Piya Sen Gupta

Abstract


Aims: EndoBarrier is a 60 cm proximal intestinal liner, endoscopically implanted for up to 1 year, designed to mimic the bypass aspect of Roux-en-Y gastric bypass surgery. We aimed to assess its safety and efficacy in patients with advanced diabesity.

Methods: Since October 2014 we have implanted 62 Endo-Barriers in our NHS service. By November 2018 all were explanted. Outcomes were monitored in a registry.

Results: In 61 of the 62 patients (98.4%) (age 51.4±7.2 years, 54.1% male, 57.4% Europid, diabetes duration 12.0 (8.0–19.5) years, 57.4% insulin-treated, BMI 41.9±7.4 kg/m2) with implant and explant data, mean±SD HbA1c fell by 23.7±21.4 mmol/mol from 80.2±22.5 to 56.5±11.5 mmol/mol (p<0.001), weight fell by 15.9±8.5 kg from 122.6±27.9 to 106.7±28.9 kg (p<0.001), systolic blood pressure from 138.5±15.0 to 125.8±14.6 mmHg (p<0.001), cholesterol from 4.7±1.4 to 3.9±0.9 mmol/L (p<0.001) and alanine aminotransferase (a marker for non-alcoholic fatty liver disease) from 33.2±19.8 to 19.5±11.4 U/L (p<0.001). In the 35 insulin-treated patients, median (IQR) insulin dose reduced from 100 (54–140) to 40 (0–70) units (p<0.001), with 10/35 (28.6%) discontinuing insulin. There were significant falls (UKPDS Risk Engine v2) in the risk of coronary heart disease (CHD) and stroke, suggesting that EndoBarrier treatment in 100 such patients could prevent 8 events of CHD or stroke and save 6 lives over the 10 years. Ten of the 62 patients (16%) required early removal (4 for gastrointestinal haemorrhage, 2 for liver abscess, 1 for another intra-abdominal abscess and 3 for gastrointestinal symptoms). All made a full recovery following device removal and most derived benefit despite early removal.

Conclusion: EndoBarrier was highly effective in this setting in patients with advanced diabetes and obesity. Given the high cardiovascular and microvascular risk of these patients, benefits might outweigh risks. As an endoscopic procedure it is relatively simple and non-invasive. Early removal rates require monitoring and there needs to be increased focus on preventing complications but, on balance, EndoBarrier deserves further investigation as a potential treatment for wider use.


Keywords


EndoBarrier, duodenal–jejunal bypass liner, DJBL, obesity, type 2 diabetes, diabesity, bariatric surgery

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References


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DOI: https://doi.org/10.15277/bjd.2019.226

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