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  • 1
    In: British Journal of Diabetes, ABCD Diabetes Care, Ltd., Vol. 18, No. 1 ( 2018-03-16), p. 14-17
    Abstract: EndoBarrier®, a 60 cm endoscopically implanted proximal intestinal liner, reduces weight and HbA1c over 1 year. We report the outcomes of the first 12 patients who completed 6 months post EndoBarrier removal in the first NHS EndoBarrier service. All patients were obese (body mass index 41.7±9.8 kg/m2) with diabetes for 10–25 years and 75% were on insulin therapy. All patients (age 52.4±9.3 years) were advised to institute behavioural changes during the implant period (1 year) and maintain them thereafter. Implantation of EndoBarrier for 1 year reduced weight (17.6±8.9 kg, p 〈 0.001), HbA1c (26.7±20.8 mmol/mol, 2.4±1.9%, p=0.001), systolic blood pressure (14.1±16.1 mmHg, p=0.011) and median total daily insulin dose from 104 to 48 Units/day (p=0.024) (n=9). Six months post EndoBarrier removal, 75% of patients sustained the metabolic improvement achieved with EndoBarrier; insulin dose requirement continued to fall and four of the nine insulin-treated patients discontinued insulin. Of the three patients whose weight/glycaemic control worsened, two had depression and one became immobile after explantation due to ill health unrelated to EndoBarrier treatment. Most (93.8%) of our patients stated that they would be extremely likely to recommend our service to friends and family. These data are encouraging for wider establishment of NHS EndoBarrier services.
    Type of Medium: Online Resource
    ISSN: 2397-6241 , 2397-6233
    Language: Unknown
    Publisher: ABCD Diabetes Care, Ltd.
    Publication Date: 2018
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  • 2
    In: Diabetes, American Diabetes Association, Vol. 69, No. Supplement_1 ( 2020-06-01)
    Abstract: EB, a 60cm endoscopically inserted proximal intestinal liner, reduces weight and HbA1c over 1 year. In the 1st NHS EB service, we provided EB to patients with sub optimally controlled diabesity and monitored outcomes in a registry. 46/62 (72%) completing 1 year post EB removal (age 51.5±7.7 years, 52% male, diabetes duration 14.5 (8-20) years, BMI 41.6±7.1 kg/m2) attended follow-up. During EB treatment, mean ± SD HbA1c fell by 1.9±1.8 %, from 9.2±1.8 to 7.2±1.0 % (p & lt;0.001), weight by 17.2±8.8 kg from 121.9 ± 29.4 to 104.7±30.1 kg ( & lt;0.001), systolic BP from 139.0±14.0 to 126.0±14.6 mmHg ( & lt;0.001), serum alanine aminotransferase (marker of liver fat) from 30.0±16.9 to 18.8±11.0 U/L (p & lt;0.001). Median (IQR) total daily insulin dose reduced from 104 (54-162) to 30 (0-62) units (n=31, p & lt;0.001); 10/31 (32%) insulin treated patients discontinued insulin. One year after EB removal 18/46 (39%) demonstrated sustained improvement, 18/46 (39%) partially sustained improvement and 10/46 (22%) reverted to baseline (Figure). Of those deteriorating, 9/10 (90%) had depression and/or bereavement. 10/62 (16%) had early EB removal for adverse events or symptoms; all 10 fully recovered after removal and most derived significant benefit. Our data demonstrates EB as highly effective in patients with refractory diabesity, with maintenance of significant improvement 1 year after removal in 78%. Disclosure R.E.J. Ryder: Consultant; Self; GI Dynamics Inc. Other Relationship; Self; Novo Nordisk A/S. M. Yadagiri: None. S.P. Irwin: None. W. Burbridge: None. M.C. Wyres: None. T. Bashir: None. H. Gandhi: None. R. Allden: None. J. Bleasdale: None. E. Fogden: None. M. Anderson: None. P. Sen Gupta: None.
    Type of Medium: Online Resource
    ISSN: 0012-1797 , 1939-327X
    Language: English
    Publisher: American Diabetes Association
    Publication Date: 2020
    detail.hit.zdb_id: 1501252-9
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  • 3
    In: Diabetes, American Diabetes Association, Vol. 71, No. Supplement_1 ( 2022-06-01)
    Abstract: EB, a 60cm endoscopically inserted proximal intestinal liner, reduces weight and HbA1c over 1 year. In the 1st NHS EB service, we provided EB to patients with sub optimally controlled diabesity and monitored outcomes in a registry. 44/62 (71%) completing 3 years post EB removal (age 51.3±7.8 years, 54% male, diabetes duration 14.56 (8-21) years, BMI 41.7±7.2 kg/m2) attended follow-up. During EB treatment, mean ± SD HbA1c fell by 1.9±1.8 %, from 9.1±1.8 to 7.2±1.0 % (p & lt;0.001) , weight by 17.3±9.0 kg from 122.8 ± 29.8 to 105.4±30.6 kg ( & lt;0.001) , systolic BP from 138.8±14.3 to 125.9±14.9 mmHg ( & lt;0.001) , serum alanine aminotransferase (liver fat marker) from 30.4±17.2 to 19.1±11.2 U/L (p & lt;0.001) . Median (IQR) total daily insulin dose reduced from 1 (50-171) to 30 (0-63) units (n=29, p & lt;0.001) ; 10/29 (34%) insulin treated patients discontinued insulin. 3-years post EB removal 33/44 (75%) maintained most of the improvement achieved with EB whilst 11/44 (25%) reverted to baseline (figure) . Of those deteriorating, all had depression and/or bereavement and/or major health problems/disability. 10/62 (16%) had early EB removal for adverse events or symptoms; all fully recovered after removal and most derived significant benefit. Our data demonstrates EB as highly effective in patients with refractory diabesity, with maintenance of significant improvement 3 years after removal in 75% Disclosure R.E.J. Ryder: None. P. Sen Gupta: None. M. Yadagiri: None. W. Burbridge: None. S.P. Irwin: None. H. Gandhi: None. M.C. Wyres: None. J. Bleasdale: None. E. Fogden: None. M. Anderson: None.
    Type of Medium: Online Resource
    ISSN: 0012-1797
    Language: English
    Publisher: American Diabetes Association
    Publication Date: 2022
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  • 4
    In: Diabetes, American Diabetes Association, Vol. 67, No. Supplement_1 ( 2018-07-01)
    Abstract: EB, a 60cm endoscopically implanted proximal intestinal liner, reduces weight and HbA1c over 1 year. In the 1st NHS EB service, we provided EB for patients with sub optimally controlled diabesity and monitored outcomes in a registry. The 1st 38 patients have completed 6 months post EB removal and of these 31/38 (82%) (age 51.4 ± 6.8 years, 51.6% male, diabetes duration 12 (6-21) years) attended follow-up. During EB implant, mean ± SD HbA1c fell by 2.5 ± 2.0%, from 10.0 ± 2.0 to 7.5 ± 1.2% (p & lt;0.001), weight by 15.8 ± 9.0 kg from 120.6 ± 27.6 to 104.9 ± 28.9 kg ( & lt;0.001), systolic BP from 138.3 ± 15.6 to 123.0 ± 14.6 mmHg ( & lt;0.001), serum alanine-aminotransferase (ALT-marker of liver fat) from 29.7 ± 17.6 to 19.6 ± 11.5 U/L (p & lt;0.001). Median (IQR) total daily insulin dose reduced from 102 (48-129) to 25 (0-59) units (p & lt;0.001), n=20. 6 months post EB explant 21/31 (68%) had maintained the improvement and this was reflected in the figures for the group as a whole (Table). 7/20 (35%) insulin treated patients discontinued insulin. Of the 10 whose weight and/or HbA1c deteriorated, 7/10(75%) had depression. 4/38 (10.5%) patients had early Endobarrier-removal: 3 GI bleed, 1 liver abscess (Table). All 4 had full recovery after removal. All other patients achieved a full year of EB treatment. Our data demonstrates EB as highly effective in patients with refractory diabesity, with maintenance of improvement after removal in 68%. Disclosure R.E.J. Ryder: Other Relationship; Self; AstraZeneca. Speaker's Bureau; Self; Bioquest, Janssen Pharmaceuticals, Inc.. Other Relationship; Self; Janssen Pharmaceuticals, Inc.. Advisory Panel; Self; Novo Nordisk A/S. M. Yadagiri: None. S.P. Irwin: None. W. Burbridge: Other Relationship; Self; Menarini Group. M.C. Wyres: None. H. Gandhi: None. M.L. Cull: None. R. Allden: None. J. Bleasdale: None. E. Fogden: None. M. Anderson: None. P. Sen Gupta: None.
    Type of Medium: Online Resource
    ISSN: 0012-1797 , 1939-327X
    Language: English
    Publisher: American Diabetes Association
    Publication Date: 2018
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  • 5
    In: Practical Diabetes, Wiley, Vol. 39, No. 3 ( 2022-05), p. 13-
    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/m 2 ) – attended follow‐up and 19/90 (21%) did not attend follow‐up. During EndoBarrier implantation, mean ± SD HbA 1c 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. Copyright © 2022 John Wiley & Sons.
    Type of Medium: Online Resource
    ISSN: 2047-2897 , 2047-2900
    URL: Issue
    Language: English
    Publisher: Wiley
    Publication Date: 2022
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  • 6
    In: Diabetes, American Diabetes Association, Vol. 69, No. Supplement_1 ( 2020-06-01)
    Abstract: EB, a 60 cm proximal intestinal liner, endoscopically-implanted for up to 1 year, reduces weight and HbA1c. As the risk of progressive kidney-disease is increased by high BMI, we assessed the impact of EB on renal function. In 89 consecutive patients (aged 51.2 ± 8.0 years, 48.3% male, 55.1% europid, diabetes duration 10.8 (7.0-16.7) years, BMI 41.3 ± 6.9 kg/m2), mean ± SD HbA1c fell by 1.9 ± 1.8 %, from 9.4 ± 1.9 to 7.5 ± 1.2 % (p & lt;0.001), weight fell by 15.0 ± 8.3 kg from 119.1 ± 26.3 to 104.1 ± 27.0 kg (p & lt;0.001), systolic blood pressure (BP) from 138.4 ± 15.5 to 126.3 ± 16.9 mmHg (p & lt;0.001) (Table 1a). With regard to renal function, mean ± SD serum creatinine improved by 5.0 ± 15.5 μmol/L from 88.9 ± 41.8 to 83.9 ± 42.1 μmol/L (p=0.003) and estimated-Glomerular-Filtration-Rate (eGFR - abbreviated MDRD equation) improved by 6.5 ±10.7 ml/min/1.73m2 from 83.6 ± 23.4 to 90.1 ± 25.7 ml/min/1.73m2 (p & lt;0.001) (Table 1b). Eight patients had raised serum creatinine ( & gt;133μmol/L) prior to EB; after implantation in 6 of these, creatinine reduced and in 3 creatinine normalised. It was noteworthy, that the 6 patients with renal impairment who sustained improvement had large weight loss (mean 17.3 kg), whereas the patients without improvement had lower weight loss (mean 6 kg). As well as previously documented improvements, in weight, HbA1c and BP, EB was associated with improvements in renal function. These observational findings warrant further investigation. Disclosure R.E.J. Ryder: Consultant; Self; GI Dynamics Inc. Other Relationship; Self; Novo Nordisk A/S. M. Yadagiri: None. S.P. Irwin: None. W. Burbridge: None. R. Allden: None. T. Bashir: None. J. Bleasdale: None. E. Fogden: None. M. Anderson: None. P. Sen Gupta: None. P. Cockwell: Speaker’s Bureau; Self; Napp Pharmaceuticals.
    Type of Medium: Online Resource
    ISSN: 0012-1797 , 1939-327X
    Language: English
    Publisher: American Diabetes Association
    Publication Date: 2020
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  • 7
    In: Diabetes, American Diabetes Association, Vol. 68, No. Supplement_1 ( 2019-06-01)
    Abstract: EB, a 60cm endoscopically inserted proximal intestinal liner, reduces weight and HbA1c over 1-year. In the 1st NHS EB service, we provided EB to patients with sub optimally controlled diabesity and monitored outcomes in a registry. 32/46 (70%) completing 1-year post EB removal (age 51.1±7.5 years, 56% male, diabetes duration 14 (8-21) years, BMI 41.7±7.8 kg/m2) attended follow-up. During EB treatment, mean ± SD HbA1c fell by 2.1±1.9%, from 9.5±1.9 to 7.4±1.1% (p & lt;0.001), weight by 17.0±8.9 kg from 121.1 ± 28.4 to 104.1±29.1 kg ( & lt;0.001), systolic BP from 140.0±15.3 to 126.4±15.9 mmHg ( & lt;0.001), serum alanine aminotransferase (marker of liver fat) from 29.1±17.7 to 18.2±9.7 U/L (p & lt;0.001). Median (IQR) total daily insulin dose reduced from 104 (60-140) to 20 (0-59) units (n=21, p & lt;0.001); 7/21 (33%) insulin treated patients discontinued insulin. 1-year post EB removal 13/32 (41%) demonstrated sustained improvement with 12/32 (37%) partially sustaining improvement and 7/32 (22%) reverting to baseline (Figure). Of those deteriorating, 6/7 (86%) had depression and/or bereavement. 41/46 (89%) achieved the planned full year of EB treatment but 5/46 (11%) had early EB removal (4 GI bleed, 1 liver abscess) with all 5 fully recovering after removal. Our data demonstrates EB as highly effective in patients with refractory diabesity, with maintenance of significant improvement 1-year after removal in 78%. Disclosure R.E.J. Ryder: Advisory Panel; Self; Novo Nordisk A/S. Speaker's Bureau; Self; Bioquest. P. Sen Gupta: None. M. Yadagiri: None. S.P. Irwin: Speaker's Bureau; Self; AstraZeneca. W. Burbridge: None. T. Bashir: None. M.C. Wyres: None. R. Allden: None. J. Bleasdale: None. E. Fogden: None. M. Anderson: None.
    Type of Medium: Online Resource
    ISSN: 0012-1797 , 1939-327X
    Language: English
    Publisher: American Diabetes Association
    Publication Date: 2019
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  • 8
    In: British Journal of Diabetes, ABCD Diabetes Care, Ltd., Vol. 21, No. 1 ( 2021-05-28), p. 76-83
    Abstract: Aims: EndoBarrier is a 60 cm duodenal–jejunal bypass liner endoscopically implanted for up to one year. It mimics the bypass part of Roux-en-Y bariatric surgery and reduces weight and HbA1c while it is in situ. We aimed to assess the extent to which these improvements are sustained in people with diabetes in the year following removal.Methods: Between October 2014 and November 2017 we implanted 62 EndoBarriers in an NHS service with all removed by November 2018. Outcomes were monitored in a registry.Results: By November 2019, 46/62 (72%) (mean±SD age 51.5±7.7 years, 52% male, 54.3% white ethnicity, median (IQR) diabetes duration 14.5 (8–20) years, 67.4% insulin-treated and mean±SD body mass index (BMI) 41.6±7.1 kg/m2) had attended and 16/62 (28%) did not attend their one-year post-EndoBarrier follow-up appointment. In those who attended, during EndoBarrier implantation mean±SD HbA1c fell by 21.1±19.6 mmol/mol from 77.1±20.0 to 56.0±11.2 mmol/mol (p 〈 0.001) (by 1.9±1.8% from 9.2±1.8% to 7.3±1.0% (p 〈 0.001)), weight fell by 17.2±8.8 kg from 121.9±29.4 kg to 104.7±30.1 kg (p 〈 0.001), BMI fell from 41.6±7.5 to 35.5±7.5 kg/m2 (p 〈 0.001), systolic blood pressure from 139.0±14.0 to 126.0±14.6 mmHg (p 〈 0.001) and serum alanine aminotransferase from 30.0±16.9 to 18.8±11.0 U/L (p 〈 0.001). Median (IQR) total daily insulin dose reduced from 104 (54–162) to 30 (0–62) units (n=31, p 〈 0.001); 10/31 (32%) insulin-treated people with diabetes were able to discontinue insulin. One year post-EndoBarrier, 18/46 (39%) demonstrated fully sustained improvement, 18/46 (39%) partially sustained improvement and 10/46 (22%) reverted to baseline. Of those deteriorating, 9/10 (90%) had depression and/or bereavement; they also had less fall in weight and HbA1c during EndoBarrier treatment. In the 16/62 (28%) who did not attend follow-up, reasons for non-attendance were too far to travel (25%), need to take time off work (6.3%), severe depression (6.3%) and death (6.3%). In 56.3% of cases no reason was given.Conclusion: Our data demonstrate that EndoBarrier is highly effective in people with long-standing poorly controlled type 2 diabetes and obesity, with maintenance of significant improvement one year after removal in 78% of cases for whom data were available. As an endoscopic procedure it is relatively simple and non-invasive and it deserves further investigation.
    Type of Medium: Online Resource
    ISSN: 2397-6241 , 2397-6233
    Language: Unknown
    Publisher: ABCD Diabetes Care, Ltd.
    Publication Date: 2021
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  • 9
    In: British Journal of Diabetes, ABCD Diabetes Care, Ltd., Vol. 22, No. 2 ( 2022-12-21), p. 82-86
    Abstract: Background and aims: EndoBarrier is a 60cm duodenal-jejunal bypass liner endoscopically implanted for up to one year and designed to mimic the bypass part of roux-en-Y bariatric surgery. There is uncertainty concerning the extent to which improvements associated with EndoBarrier treatment are sus-tained once the liner has been removed. We aimed therefore to establish an EndoBarrier service for refractory diabesity and to continue to monitor the people with diabetes after EndoBarrier removal. Methods: Between October 2014 and November 2017, we implanted 62 EndoBarriers in our NHS service. All had been removed by November 2018. Outcomes were monitored in a registry. Results: As of November 2021, all patients reached three years after EndoBarrier removal and of these 43/62 (69%) (mean±SD age 51.6 ± 7.6 years, 55.8% male, 55.8% white ethnicity, median [IQR] diabetes duration 14.6 [8 – 21] years, 62.8% insulin-treated, mean±SD BMI 41.7±7.3 kg/m2) attended follow-up. In those who attended, during EndoBarrier implantation mean±SD HbA1c fell by 20.6±19.6 mmol/mol from 76.3±19.2 to 55.7±11.1 mmol/mol (p 〈 0.001) (by 1.9±1.8% from 9.1±1.8% to 7.2±1.0% [p 〈 0.001]), weight fell by 17.4±9.1 kg from 123.3±30.0 kg to 105.9±30.8 kg (p 〈 0.001), BMI fell from 41.7±7.3 to 35.6±7.7 kg/m2 (p 〈 0.001), systolic blood pressure from 138.7±14.4 to 125.4±14.7 mmHg (p 〈 0.001), cholesterol from 4.6±1.0 to 3.7±0.7mmol/L (p 〈 0.001), and serum alanine aminotransferase from 30.8±17.2 to 19.3±11.2 U/L (p 〈 0.001). In those taking insulin median (IQR) total daily insulin dose reduced from 114 (54–180) to 20 (0–65) units (n=27, p 〈 0.001); 10/27 (37%) insulin-treated people were able to discontinue insulin. Three years after EndoBarrier removal 33/43 (77%) maintained most of the improvement achieved with EndoBarrier whilst 10/43(23%) reverted to baseline. Of those deteriorating 9/10(90%) had depression and/or bereavement and/or major health problems/disability. 10/62(16%) required early Endo-Barrier removal for adverse events or symptoms; all 10 fully recovered after removal and most derived significant benefit. Conclusions: Our data demonstrate that EndoBarrier is highly effective in people with refractory diabesity, with mainte-nance of significant improvement three years after removal in 77% of cases.
    Type of Medium: Online Resource
    ISSN: 2397-6241 , 2397-6233
    Language: Unknown
    Publisher: ABCD Diabetes Care, Ltd.
    Publication Date: 2022
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  • 10
    In: British Journal of Diabetes, ABCD Diabetes Care, Ltd., Vol. 19, No. 2 ( 2019-12-17), p. 110-117
    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.
    Type of Medium: Online Resource
    ISSN: 2397-6241 , 2397-6233
    Language: Unknown
    Publisher: ABCD Diabetes Care, Ltd.
    Publication Date: 2019
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