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Outcomes associated with a transcarotid artery revascularization-centered protocol in high-risk carotid revascularizations using the ENROUTE neuroprotection system.

Abstract：

OBJECTIVE: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). METHODS: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. RESULTS: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. CONCLUSIONS: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.

journal_name

J Vasc Surg

journal_title

Journal of vascular surgery

authors

Wang SK,Fajardo A,Sawchuk AP,Lemmon GW,Dalsing MC,Gupta AK,Murphy MP,Motaganahalli RL

doi

10.1016/j.jvs.2018.06.222

subject

Has Abstract

pub_date

2019-03-01 00:00:00

pages

807-813

issue

eissn

0741-5214

issn

1097-6809

pii

S0741-5214(18)31983-9

journal_volume

pub_type

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Outcomes associated with a transcarotid artery revascularization-centered protocol in high-risk carotid revascularizations using the ENROUTE neuroprotection system.