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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.

Publication ,  Journal Article
Barnes, JA; Eid, MA; Moore, K; Aryal, S; Gebre, E; Woodard, JN; Kitpanit, N; Mao, J; Kuwayama, DP; Suckow, BD; Schneider, D; Abushaikha, T ...
Published in: BMJ Surg Interv Health Technol
2022

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.

Duke Scholars

Published In

BMJ Surg Interv Health Technol

DOI

EISSN

2631-4940

Publication Date

2022

Volume

4

Issue

1

Start / End Page

e000085

Location

England
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Barnes, J. A., Eid, M. A., Moore, K., Aryal, S., Gebre, E., Woodard, J. N., … Goodney, P. (2022). 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. BMJ Surg Interv Health Technol, 4(1), e000085. https://doi.org/10.1136/bmjsit-2021-000085
Barnes, Jonathan Aaron, Mark A. Eid, Kayla Moore, Suvekshya Aryal, Eden Gebre, Jennifer Nicole Woodard, Napong Kitpanit, et al. “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.BMJ Surg Interv Health Technol 4, no. 1 (2022): e000085. https://doi.org/10.1136/bmjsit-2021-000085.
Barnes JA, Eid MA, Moore K, Aryal S, Gebre E, Woodard JN, Kitpanit N, Mao J, Kuwayama DP, Suckow BD, Schneider D, Abushaikha T, Zusterzeel R, Vemulapalli S, Shenkman EA, Williams J, Sedrakyan A, Goodney P. 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. BMJ Surg Interv Health Technol. 2022;4(1):e000085.

Published In

BMJ Surg Interv Health Technol

DOI

EISSN

2631-4940

Publication Date

2022

Volume

4

Issue

1

Start / End Page

e000085

Location

England