Division of Vascular and Endovascular Surgery, Mayo Clinic, Rochester, MN.
Division of Vascular and Endovascular Surgery, Mayo Clinic, Rochester, MN.
J Vasc Surg. 2024 Oct;80(4):1204-1215.e2. doi: 10.1016/j.jvs.2024.05.012. Epub 2024 Jun 20.
The Human Acellular Vessel (HAV) is a novel, off-the-shelf biologic conduit being evaluated for arterial reconstructions. Regulatory studies in peripheral arterial disease (PAD) to date have consisted of single-arm cohorts with no comparator groups to contrast performance against established standards. This study aimed to compare outcomes of the HAV with autologous great saphenous vein (GSV) in patients with advanced PAD undergoing infrageniculate bypass.
Patients with advanced PAD and no autologous conduit who underwent bypass with the 6-mm diameter HAV (Group 1; n = 34) (March 2021-February 2024) were compared with a multicenter historical cohort who had bypass with single-segment GSV (group 2; n = 88) (January 2017-December 2022). The HAV was used under an Investigational New Drug protocol issued by the Food and Drug Administration (FDA) under the agency's Expanded Access Program.
Demographics were comparable between groups (mean age 69 ± 10 years; 71% male). Group 1 had higher rates of tobacco use (37 pack-years vs 28 pack-years; P = .059), coronary artery disease (71% vs 43%; P = .007), and prior coronary artery bypass grafting (38% vs 14%; P = .003). Group 1 had more patients classified as wound, ischemia, and foot infection clinical stage 4 (56% vs 33%; P = .018) and with previous index leg revascularizations (97% vs 53%; P < .001). Both groups had a similar number of patients with chronic limb-threatening ischemia (Rutherford class 4-6) (88% vs 86%; P = .693) and Global Anatomic Staging System stage III (91% vs 96%; P = .346). Group 1 required a composite conduit (two HAV sewn together) in 85% of bypasses. The tibial vessels were the target in 79% of group 1 and 100% of group 2 (P < .001). Group 1 had a lower mean operative time (364 minutes vs 464 minutes; P < .001). At a median of 12 months, major amputation-free survival (73% vs 81%; P = .55) and overall survival (84% vs 88%; P = .20) were comparable. Group 1 had lower rates of primary patency (36% vs 50%; P = .044), primary-assisted patency (45% vs 72%; P = .002), and secondary patency (64% vs 72%; P = .003) compared with group 2.
Implanted under Food and Drug Administration Expanded Access provisions, the HAV was more likely to be used in redo operations and cases with more advanced limb ischemia than GSV. Despite modest primary patency, the HAV demonstrated resilience in a complex cohort with no autologous conduit options, achieving good secondary patency and providing major amputation-free survival comparable with GSV at 12 months.
人去细胞血管（HAV）是一种新型的即用型生物导管，正在评估用于动脉重建。迄今为止，外周动脉疾病（PAD）的监管研究包括没有对照组的单臂队列，无法与既定标准进行对比。本研究旨在比较 HAV 与自体大隐静脉（GSV）在接受膝下旁路手术的晚期 PAD 患者中的结果。
接受 6 毫米直径 HAV（组 1；n=34）（2021 年 3 月至 2024 年 2 月）旁路手术的晚期 PAD 且无自体移植物的患者与接受单段 GSV（组 2；n=88）旁路手术的多中心历史队列进行比较（2017 年 1 月至 2022 年 12 月）。HAV 是根据食品和药物管理局（FDA）的一项调查性新药协议使用的，该协议是该机构扩大准入计划的一部分。
两组的人口统计学特征相当（平均年龄 69±10 岁；71%为男性）。组 1 的吸烟量更高（37 包年与 28 包年；P=0.059），冠心病（71%与 43%；P=0.007）和先前的冠状动脉旁路移植术（38%与 14%；P=0.003）也更多。组 1 有更多的患者被归类为伤口、缺血和足部感染临床 4 期（56%与 33%；P=0.018）和有先前的索引腿血运重建（97%与 53%；P<0.001）。两组慢性肢体威胁性缺血（Rutherford 分级 4-6）（88%与 86%；P=0.693）和全球解剖分期系统 3 期（91%与 96%；P=0.346）的患者数量相似。组 1 在 85%的旁路手术中需要复合移植物（两条 HAV 缝合在一起）。79%的组 1 患者和 100%的组 2 患者的目标是胫骨血管（P<0.001）。组 1 的平均手术时间较短（364 分钟与 464 分钟；P<0.001）。中位随访 12 个月时，主要免于截肢的生存率（73%与 81%；P=0.55）和总生存率（84%与 88%；P=0.20）相当。组 1 的初次通畅率（36%与 50%；P=0.044）、初次辅助通畅率（45%与 72%；P=0.002）和二次通畅率（64%与 72%；P=0.003）均低于组 2。
根据 FDA 扩大准入规定植入的 HAV 更有可能用于再次手术和更严重肢体缺血的病例，而不是 GSV。尽管初次通畅率较低，但 HAV 在没有自体移植物选择的复杂患者队列中表现出了弹性，在没有自体移植物选择的复杂患者队列中实现了良好的二次通畅率，并在 12 个月时提供了与 GSV 相当的免于主要截肢的生存率。
