Vascular and Endovascular Surgery, Mayo Clinic Health Systems, Eau Claire, WI.
Division of Vascular and Endovascular Surgery, University of Virginia, Charlottesville, VA.
Mayo Clin Proc. 2024 Jan;99(1):57-68. doi: 10.1016/j.mayocp.2023.05.004. Epub 2023 Aug 3.
To report outcomes of the human acellular vessel (HAV) implanted for limb salvage through the Food and Drug Administration (FDA) Expanded Access Program for patients with chronic limb-threatening ischemia with no autologous conduit.
The HAV is a bioengineered vascular conduit designed with human vascular smooth muscle cells. The product is under regulatory study. From April 2019 to November 2021, the HAV was implanted in 14 patients (12 men; mean age, 62±14 years) at 3 US centers. Each case was performed with a single-use investigational new drug Expanded Access Program issued by the FDA. Institutional review board approval was obtained; technical and clinical outcomes were analyzed.
A single 6-mm-diameter (40-cm-long) HAV was implanted in 9 patients; 5 patients required 2 HAVs sewn together as a composite. Technical success was 100%. Median follow-up was 12 (range, 1 to 41) months. Primary and secondary patency rates were 72% and 81% at 12 months; assisted primary patency was attained in 4 patients. Amputation-free survival was 93% at 6 months and 77% at 12 months. All patients with a patent HAV experienced clinical improvement with no HAV-related infections or adverse events. There were 4 deaths in the cohort, late mortality unrelated to the HAV.
The HAV is a safe and effective "off-the-shelf" biologic conduit. This experience from the FDA Expanded Access Program in this population with few alternative limb salvage options will help guide regulatory deliberations for patients with lower extremity ischemia and no autologous bypass conduit options.
报告在没有自体移植物的情况下，通过食品和药物管理局（FDA）扩大准入计划，为患有慢性肢体威胁性缺血的患者植入人去细胞血管（HAV）以进行肢体挽救的结果。
HAV 是一种生物工程血管移植物，设计用于人体血管平滑肌细胞。该产品正在进行监管研究。从 2019 年 4 月到 2021 年 11 月，在 3 个美国中心对 14 名患者（12 名男性；平均年龄 62±14 岁）植入了 HAV。每个病例均使用 FDA 发放的单次使用研究性新药扩大准入计划进行。获得机构审查委员会批准；分析技术和临床结果。
9 名患者植入了单个 6 毫米直径（40 厘米长）的 HAV；5 名患者需要将 2 个 HAV 缝合在一起作为复合材料。技术成功率为 100%。中位随访时间为 12 个月（范围，1 至 41 个月）。12 个月时，原发性和继发性通畅率分别为 72%和 81%；4 名患者获得辅助原发性通畅。6 个月和 12 个月时的无截肢生存率分别为 93%和 77%。所有 HAV 通畅的患者均有临床改善，无 HAV 相关感染或不良事件。该队列中有 4 例死亡，晚期死亡率与 HAV 无关。
HAV 是一种安全有效的“现成”生物管。该经验来自 FDA 扩大准入计划，在这种情况下，下肢缺血且没有自体旁路移植物选择的患者，这将有助于为这些患者的监管审议提供指导。
