PT - JOURNAL ARTICLE AU - Jonathan Aaron Barnes AU - Mark A Eid AU - Kayla Moore AU - Suvekshya Aryal AU - Eden Gebre AU - Jennifer Nicole Woodard AU - Napong Kitpanit AU - Jialin Mao AU - David P Kuwayama AU - Bjoern D Suckow AU - Darren Schneider AU - Tiffany Abushaikha AU - Robbert Zusterzeel AU - Sreekanth Vemulapalli AU - Elizabeth A Shenkman AU - James Williams AU - Art Sedrakyan AU - Philip Goodney TI - 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 AID - 10.1136/bmjsit-2021-000085 DP - 2022 Jul 01 TA - BMJ Surgery, Interventions, & Health Technologies PG - e000085 VI - 4 IP - 1 4099 - http://sit.bmj.com/content/4/1/e000085.short 4100 - http://sit.bmj.com/content/4/1/e000085.full AB - 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.No data are available. Data contains PHI and is governed by bilateral data sharing agreements between the Coordinating Center Site and Duke and OneFlorida, and pre-existing agreements with the Society for Vascular Surgery Patient Safety Organisation, and AHRQ listed patient safety organisation. Due to the small sample size, data can not be shared.