Objective: Transcarotid artery revascularization (TCAR) using the ENROUTE Neuroprotection System (Silk Road Medical) is a United States Food and Drug Administration–approved treatment modality for stroke risk reduction in the setting of carotid artery stenosis. The goal of this investigation was to define the real-world outcomes associated with the application of this technique to patients presenting with restenosis after previous carotid endarterectomy (CEA) or transfemoral carotid artery stenting (TF-CAS). Methods: Retrospective review of prospectively maintained institutional databases capturing all nontrial TCARs performed between August 2013 and July 2018 using the ENROUTE Neuroprotection System was completed at 3 unaffiliated hospital systems and unified for descriptive outcomes analysis. Results: During the study period, 237 combined TCARs were performed at our respective institutions. Of these procedures, 55 stents were implanted for the indication of restenosis after previous carotid revascularization (47 CEA, 8 TF-CAS). Within the 30-day perioperative period, we observed no ipsilateral strokes or deaths; one patient experienced perioperative myocardial infarction (MI; 1.8%). We noted a 4.8% incidence of postoperative hematoma, but none of these events were clinically significant as no reinterventions were performed in any of the 55 patients. Additionally, we did not observe any cases of stent thrombosis or pulmonary embolus. Mean length of stay was 2.2 ± 2.8 days. Our mean follow-up duration was 15.0 ± 9.2 months. Throughout the follow-up period, we did not observe any additional stroke or MI events. Additionally, there were no cases of in-stent restenosis, thrombosis, or reinterventions. Conclusion: Transcarotid artery revascularization can be performed in patients with restenotic carotid arteries with acceptable rates of ipsilateral stroke, MI, and death as demonstrated in this small multi-institutional series.

中文翻译：

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经颈动脉血运重建治疗颈动脉再狭窄

目的：使用 ENROUTE 神经保护系统（丝绸之路医疗）的经颈动脉血运重建术 (TCAR) 是美国食品和药物管理局批准的用于降低颈动脉狭窄情况下中风风险的治疗方式。这项调查的目的是确定与将该技术应用于既往颈动脉内膜切除术 (CEA) 或经股动脉颈动脉支架术 (TF-CAS) 后出现再狭窄的患者相关的真实世界结果。方法：在 3 个非附属医院系统完成了对前瞻性维护的机构数据库的回顾性审查，该数据库包含 2013 年 8 月至 2018 年 7 月期间使用 ENROUTE 神经保护系统执行的所有非试验 TCAR，并统一用于描述性结果分析。结果：在研究期间，在我们各自的机构进行了 237 次联合 TCAR。在这些手术中，有 55 个支架植入了先前颈动脉血运重建后的再狭窄指征（47 个 CEA，8 个 TF-CAS）。在 30 天的围手术期，我们没有观察到同侧卒中或死亡；一名患者出现围手术期心肌梗死（MI；1.8%）。我们注意到术后血肿的发生率为 4.8%，但这些事件均无临床意义，因为 55 名患者均未进行再干预。此外，我们没有观察到任何支架血栓形成或肺栓塞病例。平均住院时间为 2.2 ± 2.8 天。我们的平均随访时间为 15.0 ± 9.2 个月。在整个随访期间，我们没有观察到任何额外的中风或 MI 事件。此外，没有支架内再狭窄病例，血栓形成或重新干预。结论：经颈动脉血运重建术可用于颈动脉再狭窄患者，其同侧卒中、MI 和死亡率可接受，如这个小型多机构系列研究所示。