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

Authors

  • Robert EJ Ryder Sandwell & West Birmingham NHS Trust, City Hospital Dudley Road Birmingham B18 7QH
  • Susan P Irwin as above
  • Wyn Burbridge as above
  • Hardeep Gandhi as above
  • Tahira Bashir as above
  • Rachael A Allden as above
  • Mordel Wilson
  • Melanie Wyres as above
  • Melissa Cull as above
  • Mahi Yadagiri as above
  • John P Bleasdale as above
  • Edward N Fogden as above
  • Mark R Anderson as above
  • Piya Sen Gupta Guy's and St Thomas' NHS Foundation Trust Guy's Hospital Great Maze Pond, London, SE1 9RT

DOI:

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

Keywords:

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

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.

Author Biographies

Robert EJ Ryder, Sandwell & West Birmingham NHS Trust, City Hospital Dudley Road Birmingham B18 7QH

Consultant, Department of diabetes

Susan P Irwin, as above

Diabetes specialist nurse. Department of diabetes

Wyn Burbridge, as above

Diabetes specialist nurse. Department of diabetes

Hardeep Gandhi, as above

Dietician, Department of dietetics

Tahira Bashir, as above

Dietician, Department of dietetics

Rachael A Allden, as above

Nurse. Endoscopy/Gastroenterology Department

Melanie Wyres, as above

EndoBarrier service co-ordinator, Department of Diabetes

Melissa Cull, as above

Data administrator, Department of Diabetes

Mahi Yadagiri, as above

Locum consultant (former research fellow). Department of Diabetes

John P Bleasdale, as above

Consultant. Department of Anaesthetics.

Edward N Fogden, as above

Consultant Gastroenterologist. Department of Gastroenterology

Mark R Anderson, as above

Consultant Gastroenterologist. Department of Gastroenterology

Piya Sen Gupta, Guy's and St Thomas' NHS Foundation Trust Guy's Hospital Great Maze Pond, London, SE1 9RT

Consultant. Department of Diabetes. (Formerly research fellow, City Hospital, Birmingham)

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Published

2019-12-17

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Original Research

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