Comparing 9-vs. 12-Month Implantation in the Worldwide EndoBarrier (EB) Registry

Uncertainty exists re risk: benefit of proximal intestinal exclusion with EB, a novel endoscopic duodenal jejunal liner device for obesity, both with and without diabetes. In view of this, during 2017, an independent, secure, on line registry was established under the auspices of the Association of British Clinical Diabetologists, for the collection of safety and efficacy data worldwide. As of December 2022, data had been entered on 1022 patients, of whom 195 (age 51.6±10.3 years, 53% male, 81% white ethnicity, BMI 39.9±6.9kg/m2) had both 9- and 12-month data entered. EB had considerable impact on weight and HbA1c (Table). There was no difference between the mean±SD reduction in HbA1c or weight at 9- vs 12-months (HbA1c: 1.39±1.67% vs 1.38±1.66% (p=0.98); weight: 11.7±8.3kg vs 12.0±8.3kg (p=0.44). The higher the HbA1c the greater the fall but again no difference between 9- and 12-months (Table). In the full registry, 43/1022 (4.2%) experienced serious adverse events (SAE). 15/43 (34.9%) SAE would have been avoided by removal at 9-months (9 liver abscess, 4 GI bleed, one cholecystitis). It was particularly noteworthy that 9/13 (69.2%) liver abscess SAEs would have been avoided by removal at 9-months. This international data from the EB registry suggests that the benefits of EB are achieved in 9-months and a reduction in the recommended implantation period from 12- to 9-months would reduce SAEs, especially the liver abscess SAE. Disclosure R.E.Ryder: Other Relationship; Novo Nordisk, Speaker's Bureau; GI Dynamics, BioQuest. J.J.Mcmaster: None. J.Chisholm: None. L.Kow: None. J.C.Mason: None. R.V.Cohen: Advisory Panel; GI Dynamics, Research Support; Medtronic, Johnson & Johnson Medical Devices Companies. P.Sen gupta: Other Relationship; Novo Nordisk. M.Yadagiri: None. L.Munro: None. H.Frydenberg: None. S.Fishman: None. J.P.Byrne: Advisory Panel; Oxford Medical Products, Join Embla, Stock/Shareholder; Join Embla. J.P.Teare: None. C.De jonge: None. J.Greve: Advisory Panel; GI Dynamics. Funding Association of British Clinical Diabetologists