Division of Vascular Surgery, Department of Surgery, Indiana University School of Medicine, Indianapolis, Ind.
Division of Vascular Surgery, Department of Surgery, Indiana University School of Medicine, Indianapolis, Ind.
J Vasc Surg. 2019 Mar;69(3):807-813. doi: 10.1016/j.jvs.2018.06.222. Epub 2018 Oct 6.
This investigation describes the perioperative and early follow-up results associated with transcarotid artery revascularization (TCAR) in patients not participating in the Safety and Efficacy Study for Reverse Flow Used During Carotid Artery Stenting Procedure II (ROADSTER-2) registry using the ENROUTE neuroprotection system (ENPS; Silk Road Medical, Sunnyvale, Calif).
A retrospective review was performed capturing all TCAR/ENPS procedures in patients deemed to be at high risk for complications after traditional carotid endarterectomy. All patients enrolled in the ROADSTER-2 registry were excluded, leaving only those treated outside trial regulations for analysis. Preoperative demographics, intraoperative variables, and perioperative and follow-up outcomes were abstracted and reported herein.
From December 2015 to January 2018, there were 75 carotid arteries treated at our institution. All interventions were performed on carotid arteries that were symptomatic with ≥50% stenosis (46.7%) or asymptomatic with ≥80% stenosis (53.3%) by duplex ultrasound and computed tomography angiography. Technical success in our series was 97.3% (73/75), with treatment failures attributed to one case of common carotid artery dissection and another secondary to stent maldeployment in the external carotid artery. Perioperative (30-day) ipsilateral stroke rate was 2.7% (n = 2), myocardial infarction incidence was 0%, and mortality rate was 2.7% (n = 2). We did not observe any cranial nerve injuries. After a mean follow-up of 8.0 ± 6.7 months, no carotid stents required reintervention. However, we noted one instance of minor (<50%) in-stent stenosis and one asymptomatic stent thrombosis. One additional ipsilateral stroke was observed on follow-up, probably from a cardiac source.
We report that dynamic reverse-flow TCAR using the ENPS continues to be safe, feasible, and efficacious with minimal risks of postoperative stroke, myocardial infarction, and mortality outside of ROADSTER-2 regulations.
本研究使用 ENROUTE 神经保护系统（ENPS；Silk Road Medical，加利福尼亚州森尼韦尔）描述了不符合 Safety and Efficacy Study for Reverse Flow Used During Carotid Artery Stenting Procedure II（ROADSTER-2）登记研究条件的患者行颈动脉血运重建术（TCAR）的围手术期和早期随访结果。
对所有接受传统颈动脉内膜切除术并发症风险较高的患者进行了回顾性分析，记录所有 TCAR/ENPS 手术。排除所有 ROADSTER-2 登记研究的患者，仅对不符合试验规定的患者进行分析。本文报告了患者的术前人口统计学资料、术中变量、围手术期和随访结果。
2015 年 12 月至 2018 年 1 月，我院共对 75 条颈动脉进行了治疗。所有干预均针对经双功超声和计算机断层血管造影检查发现狭窄≥50%（46.7%）的有症状颈动脉或狭窄≥80%（53.3%）的无症状颈动脉。本研究的技术成功率为 97.3%（73/75），治疗失败归因于一例颈总动脉夹层和另一例支架在颈外动脉中展开不良。围手术期（30 天）同侧卒中发生率为 2.7%（n=2），心肌梗死发生率为 0%，死亡率为 2.7%（n=2）。未观察到任何颅神经损伤。平均 8.0±6.7 个月的随访期间，无需再次干预颈动脉支架。然而，我们注意到一例轻微（<50%）支架内狭窄和一例无症状支架内血栓形成。随访中还观察到另一次同侧卒中，可能来自心脏源。
在 ROADSTER-2 规定之外，我们报告使用 ENPS 的动态逆行 TCA 仍然是安全、可行和有效的，术后卒中、心肌梗死和死亡率的风险极小。
