Department of Surgery, Charleston Area Medical Center Health System Inc, Charleston, WV, USA.
Vascular. 2023 Dec;31(6):1161-1172. doi: 10.1177/17085381221106330. Epub 2022 May 29.
Transcarotid Artery Revascularization (TCAR) using the ENROUTE system (Silk Road) has been proposed as a safe and effective alternative to both carotid endarterectomy (CEA) and transfemoral carotid artery stenting (TF-CAS). Two large registries (ROADSTER 1 and ROADSTER 2) have shown that TCAR has acceptable/low rates of perioperative stroke/death. This study will analyze the 30-day perioperative and 1-year clinical outcomes from a single-center.
This is a retrospective analysis of prospectively collected data from SVS/VQI TCAR surveillance project (TSP) of 100 consecutive patients (102 TCAR procedures) done in our institution. These procedures were done for high-risk patients for CEA, which included anatomical (previous CEA, high cervical lesion, neck radiation, stoma, arch type, etc.), physiological (CHF, severe coronary artery disease, COPD on O therapy, etc.) and combined anatomical/physiological reasons. These procedures were done by vascular surgeons after receiving the appropriate training. The perioperative stroke, death, and MI rates were analyzed. Kaplan Meyer analysis was used to estimate rate of freedom from stroke/death and the incidence of ≥50% and ≥80% in-stent restenosis at 1 year.
100 consecutive high-risk patients for CEA included: 38% anatomical, 44% physiological, and 18% combined anatomical and physiological reasons. The mean age was 72.5 years (range 52-90 years). Indications for TCAR were 34% for symptomatic lesions (TIA/stroke) and 66% for asymptomatic lesions. Mean ipsilateral treated stenosis was 80.4%. Contralateral ≥50% stenosis/occlusion was present in 31% of patients. Technical success rate was 100%. 92% had pre-stenting PTA and 26% had post-stenting PTA. The mean flow reversal time was 8.5 min (range 3-26 min). The 30-day perioperative stroke rate was 2.9% (1/67, 1.5% for asymptomatic patients), the stroke/death rate was 2.9%, and stroke/death and MI rate was 3.9% (4/102). Other perioperative complications included cranial nerve injury 3/102 (2.9%), carotid artery dissection (2%), and major hematoma (necessitated operation evacuation) (5.9%). Freedom from stroke rates and stroke/death rates at 1 year were: 90% and 89%. Freedom from ≥50% and ≥80% in-stent restenosis rates at 1 year were 82% and 90%, respectively. None of these restenosis were symptomatic except two (2/13). Freedom from reintervention rate at 1 year was 98%.
Although the perioperative events were somewhat higher than what has been reported in previous registries, TCAR for patients who are high-risk for CEA has a low perioperative stroke and stroke/death rates with satisfactory outcome at 1 year. Further long-term data is probably needed to verify long-term outcome.
经颈动脉血管重建术（TCAR）使用 ENROUTE 系统（丝绸之路）已被提议作为颈动脉内膜切除术（CEA）和经股动脉颈动脉支架置入术（TF-CAS）的安全有效的替代方法。两项大型注册研究（ROADSTER 1 和 ROADSTER 2）表明，TCAR 具有可接受/较低的围手术期卒中/死亡率。本研究将分析来自单中心的 30 天围手术期和 1 年临床结果。
这是对我们机构进行的 SVS/VQI TCAR 监测项目（TSP）的前瞻性收集数据的回顾性分析，共 100 例连续患者（102 例 TCAR 手术）。这些手术是为 CEA 高危患者进行的，包括解剖学（既往 CEA、高位颈椎病变、颈部放射治疗、造口术、弓型等）、生理学（充血性心力衰竭、严重冠状动脉疾病、需要 O 治疗的慢性阻塞性肺病等）和联合解剖/生理原因。这些手术由接受过适当培训的血管外科医生进行。分析围手术期卒中、死亡和心肌梗死的发生率。Kaplan-Meier 分析用于估计 1 年内无卒中/死亡和支架内再狭窄发生率≥50%和≥80%的比例。
100 例 CEA 高危患者包括：38%的解剖学原因，44%的生理学原因，18%的联合解剖和生理学原因。平均年龄为 72.5 岁（52-90 岁）。TCAR 的适应证为 34%的症状性病变（TIA/卒中）和 66%的无症状性病变。同侧治疗狭窄程度平均为 80.4%。31%的患者对侧存在≥50%狭窄/闭塞。技术成功率为 100%。92%的患者术前进行了支架内预扩张，26%的患者术后进行了支架内预扩张。平均血流逆转时间为 8.5 分钟（3-26 分钟）。30 天围手术期卒中发生率为 2.9%（1/67，无症状患者为 1.5%），卒中/死亡率为 2.9%，卒中/死亡和心肌梗死发生率为 3.9%（4/102）。其他围手术期并发症包括颅神经损伤 3/102（2.9%）、颈动脉夹层（2%）和大血肿（需要手术清除）（5.9%）。1 年时无卒中率和卒中/死亡率分别为 90%和 89%。1 年时支架内再狭窄发生率≥50%和≥80%的比例分别为 82%和 90%。除 2 例（2/13）外，其余再狭窄均无症状。1 年时再干预率为 98%。
尽管围手术期事件略高于之前注册研究报道，但对于 CEA 高危患者，TCAR 具有较低的围手术期卒中率和卒中/死亡率，1 年时的结果令人满意。可能需要进一步的长期数据来验证长期结果。
