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

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.

The United Kingdom’s first NHS EndoBarrier service for long-standing poorly controlled type 2 diabetes and obesity: outcomes one year after EndoBarrier removal

“…We have described previously a comprehensive two-year pathway for the management of these people with diabetes who were seen at the Diabetes Centre at City Hospital in Birmingham, UK, in an NHS clinic specifically set up for the purpose. 8 During the year following EndoBarrier removal there were telephone consultations between the patient and Diabetes Specialist Nurse (DSN) one week and one month after removal of EndoBarrier. Thereafter there were three-monthly clinic consultations with the DSN and diabetes physician, with dietician consultation according to need.…”

“…We treated 62 people with diabetes with EndoBarrier in this service. 8 By November 2018 all 62 had had the EndoBarrier removed and we were able to demonstrate 8 considerable improvements in haemoglobin A1c (HbA1c), weight, systolic blood pressure, cholesterol, alanine aminotransferase as a marker of non-alcoholic fatty liver disease, 9 and in the need for insulin. There were also significant falls in the risk of coronary heart disease and stroke as indicated by the UKPDS Risk Engine v2.…”

“…This form of reversible bariatric procedure has been shown to reduce weight and improve glycaemic control in people with diabetes and obesity. [2][3][4][5][6][7][8] As previously described in detail elsewhere, 8 we established in 2014 a National Health Service (NHS) service providing EndoBarrier treatment to people with long-standing poorly controlled type 2 diabetes and obesity which continued to be a problem despite all attempts to improve the situation with diet and lifestyle mea-sures as well as available diabetes medications. We treated 62 people with diabetes with EndoBarrier in this service.…”

“…There were also significant falls in the risk of coronary heart disease and stroke as indicated by the UKPDS Risk Engine v2. 8,10 We gave details of the 10 out of 62 people with diabetes requiring early removal due to side effects, all of whom made a full recovery following device removal with most deriving considerable benefit despite the early removal. 8 Despite the dramatic impact of this endoscopic treatment on so many health parameters, there remains uncertainty regarding the extent to which such EndoBarrier-induced improvements are maintained following its removal.…”

“…8,10 We gave details of the 10 out of 62 people with diabetes requiring early removal due to side effects, all of whom made a full recovery following device removal with most deriving considerable benefit despite the early removal. 8 Despite the dramatic impact of this endoscopic treatment on so many health parameters, there remains uncertainty regarding the extent to which such EndoBarrier-induced improvements are maintained following its removal. 2 We therefore aimed to follow our 62 people with diabetes during the year after EndoBarrier removal to assess the extent to which the benefits were sustained.…”