One-year outcomes after transcarotid artery revascularization (TCAR) in the ROADSTER 2 trial

Kashyap, Vikram S.; So, Kristine L.; Schneider, Peter A.; Rathore, Rama; Pham, Thi; Motaganahalli, Raghu L.; Massop, Douglas W.; Foteh, Mazin I.; Eckstein, Hans‐Henning; Jim, Jeffrey; Lorenzo, José Ignacio; Melton, James G

doi:10.1016/j.jvs.2022.03.872

Cited by 25 publications

(11 citation statements)

References 20 publications

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“… 6 Recent reports of one-year data from ROADSTER 2 show no ipsilateral stroke up to 1 year after TCAR. 7 These data from ROADSTER 2 also included high anatomic or physiological risk patients, similar to our study. Multiple other studies support the safety and efficacy of the TCAR procedure.…”

Section: Discussionmentioning

confidence: 67%

Quantification of new intracerebral lesions on diffusion-weighted magnetic resonance imaging after transcarotid artery revascularization for treatment of carotid artery stenosis

Balceniuk¹,

Gonring²,

Wang³

et al. 2023

Journal of Vascular Surgery Cases, Innovations and Techniques

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Section: Discussionmentioning

confidence: 67%

Quantification of new intracerebral lesions on diffusion-weighted magnetic resonance imaging after transcarotid artery revascularization for treatment of carotid artery stenosis

Balceniuk¹,

Gonring²,

Wang³

et al. 2023

Journal of Vascular Surgery Cases, Innovations and Techniques

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“…Furthermore, TCAR's long-term durability still remains unknown, as currently, 1-year outcome estimates are the longest follow-up available among large observational studies. 10,11,27,41,42 Despite this, in May, 2022, the FDA granted an expanded indication to TCAR, approving its use among standard-risk patients. 43 This widespread utilization and now expanded FDA approval highlights the need for a rigorous randomized trial to determine the safety and efficacy profile of TCAR versus other treatment modalities, which cannot be established with registry studies alone.…”

Section: Discussionmentioning

confidence: 99%

Adoption and Diffusion of Transcarotid Artery Revascularization in Contemporary Practice

Columbo,

Stone,

Martinez-Camblor

et al. 2023

Circ: Cardiovascular Interventions

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BACKGROUND: In 2015, the FDA approved transcarotid artery revascularization (TCAR) as an alternative to carotid endarterectomy (CEA) and transfemoral carotid artery stenting (TF-CAS) for high-risk patients with carotid stenosis. This was granted in the absence of level 1 evidence to support TCAR. We aimed to document trends in TCAR utilization, its diffusion over time, and the clinical phenotypes of patients undergoing TCAR, CEA, and TF-CAS. METHODS: We used the Vascular Quality Initiative to study patients who underwent TCAR. We calculated the number of TCARs performed and the percent of TCAR utilization versus CEA/TF-CAS. Using data from before TCAR was widespread, we calculated propensity scores for patients to receive CEA. We applied this model to patients undergoing carotid revascularization from 2016 to 2022 and grouped patients by the procedure they ultimately underwent, examining overlap in score distribution to measure patient similarity. We measured the trend of in-hospital stroke/death after TCAR. RESULTS: We studied 31 447 patients who underwent TCAR from January 1, 2016 to March 31, 2022. The number of centers performing TCAR increased from 29 to 606. In 2021, TCAR represented 22.5% of carotid revascularizations at centers offering all 3 procedures. The percentage of patients that underwent TCAR who met approved high-risk criteria decreased from 88.5% to 80.9% ( P <0.001). Those with a prior ipsilateral carotid procedure decreased from 20.6% in 2016 to 12.0% in 2021 ( P <0.001). Patients undergoing TCAR after stroke increased from 19.7% to 30.7% ( P <0.001). Propensity-score overlap was 55.4% for TCAR/CEA, and 58.6% for TCAR/TF-CAS, demonstrating that TCAR patients have a clinical phenotype mixed between those who undergo CEA and TF-CAS. The average in-hospital stroke/death risk after TCAR was 2.3% in 2016 and 1.7% in 2022 ( P trend: 0.954). CONCLUSIONS: TCAR now represents nearly 1-in-4 procedures at centers offering it. TCAR was increasingly performed among standard-risk patients and as a first-line procedural option after stroke. The absence of level 1 evidence underscores the importance of high-quality registry-based analyses to document TCAR’s real-world outcomes and durability.

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“…1 This initial report has since been confirmed in subsequent post-market surveillance derived studies. 2,3 As the interest in TCAR has increased in the past decade, more attention is being paid to the procedure's technical considerations. Many early adopters are performing these interventions in a hybrid operating room (OR).…”

Section: Introductionmentioning

confidence: 99%

“…1 This initial report has since been confirmed in subsequent post-market surveillance derived studies. 2,3…”

Section: Introductionmentioning

confidence: 99%

Fixed compared to mobile imaging arms for transcarotid artery revascularization

et al. 2022

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Objective Transcarotid artery revascularization (TCAR) is a new surgical option for carotid artery stenosis. While this procedure is optimally performed in hybrid operating rooms (OR), it is currently unclear whether it could be safely performed using portable, C-arm fluoroscopy with equivalent results. The aim of this study is to determine whether there are differences in intraoperative and perioperative outcomes stratified by imaging modality. Methods A retrospective review of all TCAR procedures attempted within our health system was performed, capturing all cases between September 2017 and May 2022. Procedures were divided into 2 cohorts, based on whether they were performed in a hybrid OR or with portable, C-arm in a standard OR. Patient demographics, intraoperative results, and postoperative outcomes were compared using univariate strategies. Results A total of 503 patients were included for review, of which 422 were performed in a hybrid OR (84%) and 81 were performed using a portable C-arm (16%). Intraoperatively, an increased estimated blood loss (47.7 ± 54.7 vs 26.1 ± 26.9 mLs, p < 0.01) and operative time was found in the cases performed in a hybrid OR. However, the fluoroscopy time was lower (4.0 ± 2.6 vs 5.2 ± 5.8 min, p = 0.01) in the setting of advanced intraoperative imaging. Postoperatively, we found no differences with respect to myocardial infarction (0.2% vs. 0%, p > 0.99), stroke (2.4% vs. 2.5%, p = 0.96), or death (0.7% vs. 2.5%, p = 0.15) between groups. Conclusions While there are some intraoperative variabilities between TCAR performed in hybrid versus standard ORs, postoperative outcomes are comparable. Therefore, the lack of a hybrid room should not be a deterrent to the adoption of TCAR.

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One-year outcomes after transcarotid artery revascularization (TCAR) in the ROADSTER 2 trial

Cited by 25 publications

References 20 publications

Quantification of new intracerebral lesions on diffusion-weighted magnetic resonance imaging after transcarotid artery revascularization for treatment of carotid artery stenosis

Quantification of new intracerebral lesions on diffusion-weighted magnetic resonance imaging after transcarotid artery revascularization for treatment of carotid artery stenosis

Adoption and Diffusion of Transcarotid Artery Revascularization in Contemporary Practice

Fixed compared to mobile imaging arms for transcarotid artery revascularization

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