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

Wang, S. Keisin; Fajardo, Andres; Sawchuk, Alan P.; Lemmon, Gary W.; Dalsing, Michael C.; Gupta, Alok; Murphy, Michael P.; Motaganahalli, Raghu L.

doi:10.1016/j.jvs.2018.06.222

Cited by 41 publications

(25 citation statements)

References 19 publications

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“…2 We published our real-world institutional data earlier on the first 75 TCARs performed outside of clinical trial regulations noting a stroke risk of 2.7%, stroke/death of 5.4%, and an MI incidence of 0%. 13 No other large single institutional series currently exist. Data gleaned from the Vascular Quality Initiative (VQI), which is limited by in-hospital rather than 30-day outcomes, seem to demonstrate equivalent outcomes of CEA as compared to TCAR.…”

Section: Discussionmentioning

confidence: 99%

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Treatment of Carotid Restenosis Using Transcarotid Revascularization

Wang

King²,

Kashyap³

et al. 2020

Vasc Endovascular Surg

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Objective: 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). Methods: 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. Results: 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. Conclusion: 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.

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Section: Discussionmentioning

confidence: 99%

“…The general and institutional techniques for TCAR have been described in detail elsewhere. 7,10,11 The majority of procedures were performed by an attending vascular surgeon with the assistance of a trainee. Patients were premedicated with a statin and dual antiplatelets before their index TCAR unless an absolute contraindication was present.…”

Section: Methodsmentioning

confidence: 99%

Treatment of Carotid Restenosis Using Transcarotid Revascularization

Wang

King²,

Kashyap³

et al. 2020

Vasc Endovascular Surg

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“…TCAR with flow reversal offers another option for treating CAS in high-risk patients 3 . TCAR has had similar stroke/death/MI rates as open CEA despite older and substantially higher risk patients 4 . Compared to TF-CAS, TCAR has significantly lower in-hospital transient ischemic attack (TIA)/stroke/death rates 5 .…”

Section: Introductionmentioning

confidence: 95%

Intravascular lithotripsy during transcarotid arterial revascularization for highly calcified lesions in high-risk patients

Henry

Hansen

Gable

et al. 2021

Journal of Vascular Surgery Cases, Innovations and Techniques

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This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. Please note that, during the production process, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.

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“…Chang et al 15 Pipinos et al 16 Alexandrescu et al 17 Criado et al 18 Faraglia et al 19 Pinter et al (PROOF) 20 Alvarez et al 21 Ortega et al 22 Kwolek et al (ROADSTER) 23 Alpaslan et al 24 Wang et al 25 Kashyap et al (ROADSTER 2) 32 Lin et al 26 Feldtman et al 27 Palombo et al 28 Schermerhorn et al 29 Christopoulos et al 30 Plessers et al 0.00 (0.00, 0.16) 0.00 (0.00, 0.09) 0.00 (0.00, 0.12) 0.00 (0.00, 0.04) 0.00 (0.00, 0.07) 0.00 (0.00, 0.08) 0.00 (0.00, 0.03) 0.00 (0.00, 0.14) 0.01 (0.00, 0.05) 0.00 (0.00, 0.05) 0.03 (0.00, 0.09) 0.00 (0.00, 0.00) 0.00 (0.00, 0.11) 0.07 (0.00, 0.32) 0.00 (0.00, 0.08) 0.00 (0.00, 0.01) 0.00 (0.00, 0.…”

Section: Studies Events Total 30 Day Mortality Effect Size (95% Ci) Weightmentioning

confidence: 99%

Editor's Choice – Early and Late Outcomes after Transcarotid Revascularisation for Internal Carotid Artery Stenosis: A Systematic Review and Meta-Analysis

Galyfos

Tsoutsas

Konstantopoulos

et al. 2021

European Journal of Vascular and Endovascular Surgery

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WHAT THIS PAPER ADDSThis systematic review summarises the evidence for transcarotid revascularisation (TCAR) in patients with internal carotid artery stenosis. This technique offers an alternative strategy in patients where carotid endarterectomy (CEA) or transfemoral stenting face difficulties. This review evaluates early and late outcomes of the method in contrast to other similar reviews. Data indicate that TCAR is safe and efficient although symptomatic patients still carry a higher risk of early cerebrovascular complications. Prospectively designed studies comparing outcomes between TCAR and CEA in symptomatic patients are needed to further evaluate the benefit of this technique.Objective: Transcarotid/transcervical revascularisation (TCAR) is an alternative to carotid endarterectomy (CEA) and transfemoral carotid stenting (tfCAS). This review aimed to evaluate pooled data on patients undergoing TCAR. Data sources: Medline, Embase, Scopus, and Cochrane Library databases were used. Review methods: This systematic review was conducted under Systematic Reviews and Meta-Analysis guidelines. Eligible studies (published online up to September 2020) reported 30 day mortality and stroke/transient ischaemic attack (TIA) rates in patients undergoing TCAR. Data were pooled in a random effects model and weight of effect for each study was also reported. Quality of studies was evaluated according to Newcastle e Ottawa scale. Results: Eighteen studies (three low, seven medium, and eight high quality) included 4 852 patients (4 867 TCAR procedures). The pooled 30 day mortality rate was 0.7% (n ¼ 32) (95% confidence interval [CI] 0.5 e 1.0), 30 day stroke rate 1.4% (n ¼ 62) (95% CI 1.0 e 1.7), and 30 day stroke/TIA rate 2.0% (n ¼ 92) (95% CI 1.4 e 2.7). Pooled technical success was 97.6% (95% CI 95.9 e 98.8). The cranial nerve injury rate was 1.2% (95% CI 0.7 e 1.9) (n ¼ 14; data from 10 studies) while the early myocardial infarction (MI) rate was 0.4% (95% CI 0.2 e 0.6) (n ¼ 16; data from 17 studies). The haematoma/bleeding rate was 3.4% (95% CI 1.7 e 5.8) (n ¼ 135; data from 10 studies), with one third of these cases needing drainage or intervention. Within a follow up of 3 e 40 months the restenosis rate was 4% (95% CI 0.1 e 13.1) (data from nine studies; n ¼ 64/530 patients) and death/stroke rate 4.5% (95% CI 1.8 e 8.4) (data from five studies; n ¼ 184/3 742 patients). Symptomatic patients had a higher risk of early stroke/TIA than asymptomatic patients (2.5% vs. 1.2%; odds ratio 1.99; 95% CI 1.01 e 3.92); p ¼ .046; data from eight studies). Conclusion: TCAR is associated with promising early and late outcomes, with symptomatic patients having a higher risk of early cerebrovascular events. More prospective comparative studies are needed in order to verify TCAR as an established alternative treatment technique.

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

Cited by 41 publications

References 19 publications

Treatment of Carotid Restenosis Using Transcarotid Revascularization

Treatment of Carotid Restenosis Using Transcarotid Revascularization

Intravascular lithotripsy during transcarotid arterial revascularization for highly calcified lesions in high-risk patients

Editor's Choice – Early and Late Outcomes after Transcarotid Revascularisation for Internal Carotid Artery Stenosis: A Systematic Review and Meta-Analysis

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