Cargando…

Safety and effectiveness of REALIZE adjustable gastric band: 5-year prospective study

BACKGROUND: The long-term safety results of the REALIZE (Ethicon Endo-Surgery, Inc., Cincinnati, OH) adjustable gastric band collected in this prospective, multicenter study in patients with morbid obesity are presented. OBJECTIVES: To determine the reoperation rate, including band revisions, replac...

Descripción completa

Detalles Bibliográficos
Autores principales: Phillips, Edward, Ponce, Jaime, Bhoyrul, Sunil, Cunneen, Scott A., Gomez, Eddie, Jacobs, Moises, Kipnes, Mark, Marema, Robert T., Schwiers, Michael, Waggoner, Jason R., DeMarchi, Janet
Formato: Online Artículo Texto
Lenguaje:English
Publicado: American Society for Bariatric Surgery. Published by Elsevier Inc. 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7826021/
https://www.ncbi.nlm.nih.gov/pubmed/33674199
http://dx.doi.org/10.1016/j.soard.2021.01.019
_version_ 1783640442656522240
author Phillips, Edward
Ponce, Jaime
Bhoyrul, Sunil
Cunneen, Scott A.
Gomez, Eddie
Jacobs, Moises
Kipnes, Mark
Marema, Robert T.
Schwiers, Michael
Waggoner, Jason R.
DeMarchi, Janet
author_facet Phillips, Edward
Ponce, Jaime
Bhoyrul, Sunil
Cunneen, Scott A.
Gomez, Eddie
Jacobs, Moises
Kipnes, Mark
Marema, Robert T.
Schwiers, Michael
Waggoner, Jason R.
DeMarchi, Janet
author_sort Phillips, Edward
collection PubMed
description BACKGROUND: The long-term safety results of the REALIZE (Ethicon Endo-Surgery, Inc., Cincinnati, OH) adjustable gastric band collected in this prospective, multicenter study in patients with morbid obesity are presented. OBJECTIVES: To determine the reoperation rate, including band revisions, replacements, and explants, resulting from a serious adverse device-related event through years 4 and 5. Various efficacy measures were also assessed as secondary objectives. SETTING: Nine academic and/or private institutions. METHODS: The participating institutions enrolled 303 patients, who were then assessed on an annual basis, with 231 patients completing 5 years of follow-up. The study parameters included reoperation rates, changes in percentage of excess weight loss (%EWL), and changes in body mass index (BMI), as well as parameters of diabetes and dyslipidemia. Quality of life was assessed using the Short Form (SF)-36 and the Impact of Weight on Quality of Life-Lite questionnaires. RESULTS: The reoperation rate due to a serious adverse event in this population at 5 years after implantation with the REALIZE gastric band was 8.9%. The most common serious adverse event was band slippage, which affected 6.9% of the study population. The mean %EWL was 35.6% ± 26.84%, and the decrease in mean BMI was −7.01 ± 5.45 kg/m(2) at 5 years. Patients experienced improvements in mean glycated hemoglobin and serum lipid levels, in addition to improvements in the quality of life measures. CONCLUSION: No new safety concerns were identified during the 5 years of follow-up. Although the results of this study did not meet the predefined safety criteria of 8% or less, the safety profile and long-term effectiveness observed in this study are consistent with those in the current literature.
format Online
Article
Text
id pubmed-7826021
institution National Center for Biotechnology Information
language English
publishDate 2021
publisher American Society for Bariatric Surgery. Published by Elsevier Inc.
record_format MEDLINE/PubMed
spelling pubmed-78260212021-01-25 Safety and effectiveness of REALIZE adjustable gastric band: 5-year prospective study Phillips, Edward Ponce, Jaime Bhoyrul, Sunil Cunneen, Scott A. Gomez, Eddie Jacobs, Moises Kipnes, Mark Marema, Robert T. Schwiers, Michael Waggoner, Jason R. DeMarchi, Janet Surg Obes Relat Dis Original Article BACKGROUND: The long-term safety results of the REALIZE (Ethicon Endo-Surgery, Inc., Cincinnati, OH) adjustable gastric band collected in this prospective, multicenter study in patients with morbid obesity are presented. OBJECTIVES: To determine the reoperation rate, including band revisions, replacements, and explants, resulting from a serious adverse device-related event through years 4 and 5. Various efficacy measures were also assessed as secondary objectives. SETTING: Nine academic and/or private institutions. METHODS: The participating institutions enrolled 303 patients, who were then assessed on an annual basis, with 231 patients completing 5 years of follow-up. The study parameters included reoperation rates, changes in percentage of excess weight loss (%EWL), and changes in body mass index (BMI), as well as parameters of diabetes and dyslipidemia. Quality of life was assessed using the Short Form (SF)-36 and the Impact of Weight on Quality of Life-Lite questionnaires. RESULTS: The reoperation rate due to a serious adverse event in this population at 5 years after implantation with the REALIZE gastric band was 8.9%. The most common serious adverse event was band slippage, which affected 6.9% of the study population. The mean %EWL was 35.6% ± 26.84%, and the decrease in mean BMI was −7.01 ± 5.45 kg/m(2) at 5 years. Patients experienced improvements in mean glycated hemoglobin and serum lipid levels, in addition to improvements in the quality of life measures. CONCLUSION: No new safety concerns were identified during the 5 years of follow-up. Although the results of this study did not meet the predefined safety criteria of 8% or less, the safety profile and long-term effectiveness observed in this study are consistent with those in the current literature. American Society for Bariatric Surgery. Published by Elsevier Inc. 2021-05 2021-01-22 /pmc/articles/PMC7826021/ /pubmed/33674199 http://dx.doi.org/10.1016/j.soard.2021.01.019 Text en © 2021 American Society for Bariatric Surgery. Published by Elsevier Inc. All rights reserved. Since January 2020 Elsevier has created a COVID-19 resource centre with free information in English and Mandarin on the novel coronavirus COVID-19. The COVID-19 resource centre is hosted on Elsevier Connect, the company's public news and information website. Elsevier hereby grants permission to make all its COVID-19-related research that is available on the COVID-19 resource centre - including this research content - immediately available in PubMed Central and other publicly funded repositories, such as the WHO COVID database with rights for unrestricted research re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for free by Elsevier for as long as the COVID-19 resource centre remains active.
spellingShingle Original Article
Phillips, Edward
Ponce, Jaime
Bhoyrul, Sunil
Cunneen, Scott A.
Gomez, Eddie
Jacobs, Moises
Kipnes, Mark
Marema, Robert T.
Schwiers, Michael
Waggoner, Jason R.
DeMarchi, Janet
Safety and effectiveness of REALIZE adjustable gastric band: 5-year prospective study
title Safety and effectiveness of REALIZE adjustable gastric band: 5-year prospective study
title_full Safety and effectiveness of REALIZE adjustable gastric band: 5-year prospective study
title_fullStr Safety and effectiveness of REALIZE adjustable gastric band: 5-year prospective study
title_full_unstemmed Safety and effectiveness of REALIZE adjustable gastric band: 5-year prospective study
title_short Safety and effectiveness of REALIZE adjustable gastric band: 5-year prospective study
title_sort safety and effectiveness of realize adjustable gastric band: 5-year prospective study
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7826021/
https://www.ncbi.nlm.nih.gov/pubmed/33674199
http://dx.doi.org/10.1016/j.soard.2021.01.019
work_keys_str_mv AT phillipsedward safetyandeffectivenessofrealizeadjustablegastricband5yearprospectivestudy
AT poncejaime safetyandeffectivenessofrealizeadjustablegastricband5yearprospectivestudy
AT bhoyrulsunil safetyandeffectivenessofrealizeadjustablegastricband5yearprospectivestudy
AT cunneenscotta safetyandeffectivenessofrealizeadjustablegastricband5yearprospectivestudy
AT gomezeddie safetyandeffectivenessofrealizeadjustablegastricband5yearprospectivestudy
AT jacobsmoises safetyandeffectivenessofrealizeadjustablegastricband5yearprospectivestudy
AT kipnesmark safetyandeffectivenessofrealizeadjustablegastricband5yearprospectivestudy
AT maremarobertt safetyandeffectivenessofrealizeadjustablegastricband5yearprospectivestudy
AT schwiersmichael safetyandeffectivenessofrealizeadjustablegastricband5yearprospectivestudy
AT waggonerjasonr safetyandeffectivenessofrealizeadjustablegastricband5yearprospectivestudy
AT demarchijanet safetyandeffectivenessofrealizeadjustablegastricband5yearprospectivestudy