Wang S Keisin, King Alexander H, Kashyap Vikram S, Foteh Mazin I, Ambani Ravi N, Apple Jeff M, Fajardo Andres C, Motaganahalli Raghu L
Division of Vascular Surgery, Department of Surgery, Indiana University School of Medicine, Indianapolis, IN, USA.
Division of Vascular Surgery, University Hospitals Cleveland Medical Center, Harrington Heart and Vascular Institute, Cleveland, OH, USA.
Vasc Endovascular Surg. 2020 Jul;54(5):436-440. doi: 10.1177/1538574420923815. Epub 2020 May 12.
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).
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.
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.
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.
使用ENROUTE神经保护系统（丝路医疗公司）进行经颈动脉血管重建术（TCAR）是美国食品药品监督管理局批准的一种治疗方式，用于降低颈动脉狭窄患者的中风风险。本研究的目的是确定将该技术应用于既往接受过颈动脉内膜切除术（CEA）或经股颈动脉支架置入术（TF-CAS）后出现再狭窄的患者的真实世界结局。
对3个非关联医院系统前瞻性维护的机构数据库进行回顾性分析，这些数据库记录了2013年8月至2018年7月期间使用ENROUTE神经保护系统进行的所有非试验性TCAR，并统一进行描述性结局分析。
在研究期间，我们各自的机构共进行了237例联合TCAR。在这些手术中，有55枚支架因既往颈动脉血管重建术后再狭窄的指征而植入（47例CEA，8例TF-CAS）。在围手术期30天内，我们未观察到同侧中风或死亡；1例患者发生围手术期心肌梗死（MI；1.8%）。我们注意到术后血肿发生率为4.8%，但这些事件均无临床意义，因为55例患者中无一例进行再次干预。此外，我们未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，我们未观察到任何额外的中风或MI事件。此外，没有支架内再狭窄、血栓形成或再次干预的病例。
本小型多机构系列研究表明，经颈动脉血管重建术可用于颈动脉再狭窄患者，同侧中风、MI和死亡发生率可接受。
