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

S. Keisin Wang, Andres Fajardo, Alan Sawchuk, Gary Lemmon, Michael Dalsing, Alok K. Gupta, Michael Murphy, Raghu Motaganahalli

Research output: Contribution to journalArticle

4 Citations (Scopus)

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.

Original languageEnglish (US)
JournalJournal of Vascular Surgery
DOIs
StateAccepted/In press - Jan 1 2018

Fingerprint

Stents
Arteries
Carotid Arteries
Pathologic Constriction
Stroke
Registries
Cranial Nerve Injuries
Myocardial Infarction
External Carotid Artery
Silk
Mortality
Carotid Endarterectomy
Common Carotid Artery
Treatment Failure
Dissection
Thrombosis
Demography
Safety
Neuroprotection
Incidence

Keywords

  • Carotid revascularization
  • ENROUTE
  • Reverse flow
  • Stenting
  • Stroke
  • TCAR

ASJC Scopus subject areas

  • Surgery
  • Cardiology and Cardiovascular Medicine

Cite this

@article{7995f25a35f54a97a758aefea42791d6,
title = "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.",
keywords = "Carotid revascularization, ENROUTE, Reverse flow, Stenting, Stroke, TCAR",
author = "Wang, {S. Keisin} and Andres Fajardo and Alan Sawchuk and Gary Lemmon and Michael Dalsing and Gupta, {Alok K.} and Michael Murphy and Raghu Motaganahalli",
year = "2018",
month = "1",
day = "1",
doi = "10.1016/j.jvs.2018.06.222",
language = "English (US)",
journal = "Journal of Vascular Surgery",
issn = "0741-5214",
publisher = "Mosby Inc.",

}

TY - JOUR

T1 - Outcomes associated with a transcarotid artery revascularization-centered protocol in high-risk carotid revascularizations using the ENROUTE neuroprotection system

AU - Wang, S. Keisin

AU - Fajardo, Andres

AU - Sawchuk, Alan

AU - Lemmon, Gary

AU - Dalsing, Michael

AU - Gupta, Alok K.

AU - Murphy, Michael

AU - Motaganahalli, Raghu

PY - 2018/1/1

Y1 - 2018/1/1

N2 - 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.

AB - 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.

KW - Carotid revascularization

KW - ENROUTE

KW - Reverse flow

KW - Stenting

KW - Stroke

KW - TCAR

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DO - 10.1016/j.jvs.2018.06.222

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