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
Department of Vascular Surgery, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, USA.
The Dartmouth Institute, Dartmouth College, Hanover, New Hampshire, USA.
BMJ Surg Interv Health Technol. 2022 Jul 29;4(1):e000085. doi: 10.1136/bmjsit-2021-000085. eCollection 2022.
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).
Multicentre retrospective cohort study.
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.
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.
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.
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.
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.
评估收集、检查和报告关于GORE EXCLUDER髂支血管内支架（IBE）与GORE VIABAHN VBX球囊扩张式血管内支架（IBE + VBX支架移植物）联合新用途的观察性真实世界证据的可行性。
多中心回顾性队列研究。
使用了四个真实世界数据源：一个国家质量改进登记处、一个全州临床研究网络、一个地区四级医疗系统和两个三级学术医疗中心。
共识别出30例使用37个IBE + VBX支架移植物的患者。其中，平均年龄为72±10.2岁，90%为男性。该队列中77%为白人，10%为黑人，3%为西班牙裔，10%为其他种族。
观察指标包括：经皮与开放手术入路的比例、重症监护病房入住情况、重症监护病房（ICU）住院时间（LOS）、总住院时间、术后并发症、出院处置和30天死亡率。
大多数（89%）病例采用经皮方式进行，5%在经皮入路失败后需要手术暴露，6%直接需要开放手术暴露。近一半（43%）患者需要入住重症监护病房，ICU住院时间中位数为1天（范围：1 - 2天）。总住院时间中位数为1天（四分位间距：1 - 2天）。术后心肌梗死为零，未报告腿部栓塞，也未报告再次干预情况。28例患者中有1例出现穿刺部位并发症，表现为血肿或假性动脉瘤。最终，97%的患者出院回家，1例患者出院后入住养老院或康复机构。围手术期30天内无死亡病例。
本项目证明了识别和整合真实世界证据的可行性，该证据与血管内装置（IBE + VBX支架移植物）的未经批准组合相关，可用于短期结局分析。这种新的证据范式有可能用于器械监测、提交给监管机构，或在适应症扩展和批准中予以考虑，需进一步努力使数据收集和传输机制系统化。
