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Use of real-world data and clinical registries to identify new uses of existing vascular endografts: combined use of GORE EXCLUDER Iliac Branch Endoprosthesis and GORE VIABAHN VBX Balloon Expandable Endoprosthesis

OBJECTIVE: To assess the feasibility of collecting, examining and reporting observational, real-world evidence regarding the novel use of the GORE EXCLUDER Iliac Branch Endoprosthesis (IBE) in conjunction with the GORE VIABAHN VBX Balloon Expandable Endoprosthesis (IBE+VBX stent graft). DESIGN: Mult...

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Autores principales: Barnes, Jonathan Aaron, Eid, Mark A, Moore, Kayla, Aryal, Suvekshya, Gebre, Eden, Woodard, Jennifer Nicole, Kitpanit, Napong, Mao, Jialin, Kuwayama, David P, Suckow, Bjoern D, Schneider, Darren, Abushaikha, Tiffany, Zusterzeel, Robbert, Vemulapalli, Sreekanth, Shenkman, Elizabeth A, Williams, James, Sedrakyan, Art, Goodney, Philip
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9345049/
https://www.ncbi.nlm.nih.gov/pubmed/35989872
http://dx.doi.org/10.1136/bmjsit-2021-000085
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author Barnes, Jonathan Aaron
Eid, Mark A
Moore, Kayla
Aryal, Suvekshya
Gebre, Eden
Woodard, Jennifer Nicole
Kitpanit, Napong
Mao, Jialin
Kuwayama, David P
Suckow, Bjoern D
Schneider, Darren
Abushaikha, Tiffany
Zusterzeel, Robbert
Vemulapalli, Sreekanth
Shenkman, Elizabeth A
Williams, James
Sedrakyan, Art
Goodney, Philip
author_facet Barnes, Jonathan Aaron
Eid, Mark A
Moore, Kayla
Aryal, Suvekshya
Gebre, Eden
Woodard, Jennifer Nicole
Kitpanit, Napong
Mao, Jialin
Kuwayama, David P
Suckow, Bjoern D
Schneider, Darren
Abushaikha, Tiffany
Zusterzeel, Robbert
Vemulapalli, Sreekanth
Shenkman, Elizabeth A
Williams, James
Sedrakyan, Art
Goodney, Philip
author_sort Barnes, Jonathan Aaron
collection PubMed
description OBJECTIVE: To assess the feasibility of collecting, examining and reporting observational, real-world evidence regarding the novel use of the GORE EXCLUDER Iliac Branch Endoprosthesis (IBE) in conjunction with the GORE VIABAHN VBX Balloon Expandable Endoprosthesis (IBE+VBX stent graft). DESIGN: Multicentre retrospective cohort study. SETTING: Four real-world data sources were used: a national quality improvement registry, a statewide clinical research network, a regional quaternary health system and two tertiary academic medical centres. PARTICIPANTS: In total, 30 patients with 37 IBE+VBX stent graft were identified. Of those, the mean age was 72±10.2 years and 90% were male. The cohort was 77% white, 10% black, 3% Hispanic and 10% other. MAIN OUTCOME MEASURES: Outcome measures included: proportion of percutaneous vs open surgical access, intensive care admission, intensive care unit (ICU) length-of-stay (LOS), total LOS, postoperative complications, discharge disposition and 30-day mortality. RESULTS: The majority (89%) of cases were performed percutaneously, 5% required surgical exposure following failed percutaneous access and 6% required open surgical exposure outright. Nearly half (43%) required intensive care admission with a median ICU LOS of 1 day (range: 1–2). Median total LOS was 1 day (IQR: 1–2). There were zero postoperative myocardial infarctions, zero reported leg embolisations and no reported reinterventions. Access site complications were described in 1 of 28 patients, manifesting as a haematoma or pseudoaneurysm. Ultimately, 97% were discharged to home and one patient was discharged to a nursing home or rehabilitation facility. There were no 30-day perioperative deaths. CONCLUSIONS: This project demonstrates the feasibility of identifying and integrating real-world evidence, as it pertains to an unapproved combination of endovascular devices (IBE+VBX stent graft), for short-term outcomes analysis. This new paradigm of evidence has potential to be used for device monitoring, submission to regulatory agencies, or consideration in indication expansions and approvals with further efforts to systematise data collection and transmission mechanisms.
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spelling pubmed-93450492022-08-19 Use of real-world data and clinical registries to identify new uses of existing vascular endografts: combined use of GORE EXCLUDER Iliac Branch Endoprosthesis and GORE VIABAHN VBX Balloon Expandable Endoprosthesis Barnes, Jonathan Aaron Eid, Mark A Moore, Kayla Aryal, Suvekshya Gebre, Eden Woodard, Jennifer Nicole Kitpanit, Napong Mao, Jialin Kuwayama, David P Suckow, Bjoern D Schneider, Darren Abushaikha, Tiffany Zusterzeel, Robbert Vemulapalli, Sreekanth Shenkman, Elizabeth A Williams, James Sedrakyan, Art Goodney, Philip BMJ Surg Interv Health Technol Original Research OBJECTIVE: To assess the feasibility of collecting, examining and reporting observational, real-world evidence regarding the novel use of the GORE EXCLUDER Iliac Branch Endoprosthesis (IBE) in conjunction with the GORE VIABAHN VBX Balloon Expandable Endoprosthesis (IBE+VBX stent graft). DESIGN: Multicentre retrospective cohort study. SETTING: Four real-world data sources were used: a national quality improvement registry, a statewide clinical research network, a regional quaternary health system and two tertiary academic medical centres. PARTICIPANTS: In total, 30 patients with 37 IBE+VBX stent graft were identified. Of those, the mean age was 72±10.2 years and 90% were male. The cohort was 77% white, 10% black, 3% Hispanic and 10% other. MAIN OUTCOME MEASURES: Outcome measures included: proportion of percutaneous vs open surgical access, intensive care admission, intensive care unit (ICU) length-of-stay (LOS), total LOS, postoperative complications, discharge disposition and 30-day mortality. RESULTS: The majority (89%) of cases were performed percutaneously, 5% required surgical exposure following failed percutaneous access and 6% required open surgical exposure outright. Nearly half (43%) required intensive care admission with a median ICU LOS of 1 day (range: 1–2). Median total LOS was 1 day (IQR: 1–2). There were zero postoperative myocardial infarctions, zero reported leg embolisations and no reported reinterventions. Access site complications were described in 1 of 28 patients, manifesting as a haematoma or pseudoaneurysm. Ultimately, 97% were discharged to home and one patient was discharged to a nursing home or rehabilitation facility. There were no 30-day perioperative deaths. CONCLUSIONS: This project demonstrates the feasibility of identifying and integrating real-world evidence, as it pertains to an unapproved combination of endovascular devices (IBE+VBX stent graft), for short-term outcomes analysis. This new paradigm of evidence has potential to be used for device monitoring, submission to regulatory agencies, or consideration in indication expansions and approvals with further efforts to systematise data collection and transmission mechanisms. BMJ Publishing Group 2022-07-29 /pmc/articles/PMC9345049/ /pubmed/35989872 http://dx.doi.org/10.1136/bmjsit-2021-000085 Text en © Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. https://creativecommons.org/licenses/by-nc/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) .
spellingShingle Original Research
Barnes, Jonathan Aaron
Eid, Mark A
Moore, Kayla
Aryal, Suvekshya
Gebre, Eden
Woodard, Jennifer Nicole
Kitpanit, Napong
Mao, Jialin
Kuwayama, David P
Suckow, Bjoern D
Schneider, Darren
Abushaikha, Tiffany
Zusterzeel, Robbert
Vemulapalli, Sreekanth
Shenkman, Elizabeth A
Williams, James
Sedrakyan, Art
Goodney, Philip
Use of real-world data and clinical registries to identify new uses of existing vascular endografts: combined use of GORE EXCLUDER Iliac Branch Endoprosthesis and GORE VIABAHN VBX Balloon Expandable Endoprosthesis
title Use of real-world data and clinical registries to identify new uses of existing vascular endografts: combined use of GORE EXCLUDER Iliac Branch Endoprosthesis and GORE VIABAHN VBX Balloon Expandable Endoprosthesis
title_full Use of real-world data and clinical registries to identify new uses of existing vascular endografts: combined use of GORE EXCLUDER Iliac Branch Endoprosthesis and GORE VIABAHN VBX Balloon Expandable Endoprosthesis
title_fullStr Use of real-world data and clinical registries to identify new uses of existing vascular endografts: combined use of GORE EXCLUDER Iliac Branch Endoprosthesis and GORE VIABAHN VBX Balloon Expandable Endoprosthesis
title_full_unstemmed Use of real-world data and clinical registries to identify new uses of existing vascular endografts: combined use of GORE EXCLUDER Iliac Branch Endoprosthesis and GORE VIABAHN VBX Balloon Expandable Endoprosthesis
title_short Use of real-world data and clinical registries to identify new uses of existing vascular endografts: combined use of GORE EXCLUDER Iliac Branch Endoprosthesis and GORE VIABAHN VBX Balloon Expandable Endoprosthesis
title_sort use of real-world data and clinical registries to identify new uses of existing vascular endografts: combined use of gore excluder iliac branch endoprosthesis and gore viabahn vbx balloon expandable endoprosthesis
topic Original Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9345049/
https://www.ncbi.nlm.nih.gov/pubmed/35989872
http://dx.doi.org/10.1136/bmjsit-2021-000085
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