Transfemoral Carotid Artery Stenting Research Articles

An evolution in carotid care: Contemporary TCAR data and optimization techniques

ObjectiveCarotid endarterectomy (CEA) is the gold standard for revascularization of atherosclerotic extra-cranial carotid artery lesions. The introduction of transfemoral carotid artery stenting (TFCAS) led to multiple randomized controlled trials to compare the safety and efficacy of an endovascular approach against traditional CEA in the management of carotid artery stenosis. The operative management of carotid artery stenosis continues to evolve, with the more recent introduction of TransCarotid artery revascularization (TCAR) and a novel flow-reversal neuroprotection system. This manuscript reviews a brief history regarding carotid artery revascularization, as well as the indications, technical considerations, and clinical outcomes of the TCAR procedure. Technical considerationsThe preoperative, intraoperative, and postoperative medical and technical considerations are explored. Topics of discussion will include the indications and contraindications for TCAR, anatomic requirements, instructions for use (IFU) and off-label utility, optimal pharmacologic regimen with carotid stent placement, standard deployment and suggestions for hostile anatomy, as well as recommended postoperative management and surveillance imaging. DiscussionThe Society for Vascular Surgery (SVS) has published a consensus statement on the pathways available to obtain clinical competency and maintain technical proficiency with TCAR. Meta-analyses reviewing the contemporary technical success and clinical outcomes of TCAR have demonstrated high rates of procedural success and low rates of stroke, myocardial infarction, and death. Studies have further illustrated comparable one-year rates of peri‑procedural stroke between TCAR and CEA, for asymptomatic and symptomatic carotid lesions, with both outperforming TFCAS. ConclusionManagement of extra-cranial carotid artery stenosis utilizing TCAR with the ENROUTE flow-reversal neuroprotection system has been widely adopted, yielding clinical outcomes and stroke prevention similar to traditional CEA and superior to TFCAS.

Impact of head and neck radiation on long-term outcomes after carotid revascularization

Radiation-induced carotid artery stenosis (RICS) is a well-described phenomenon seen after head and neck cancer radiation. Previously published literature suggests that compared to atherosclerotic disease, RICS may result in worse long-term outcomes and early restenosis. This study aims to evaluate the effect of radiation on long-term outcomes after various carotid revascularization techniques using a multi-center registry database. Patients in the Society for Vascular Surgery (SVS) Vascular Quality Initiative (VQI) registry for carotid artery intervention (carotid endarterectomy, CEA; transfemoral carotid artery stenting, CAS; transcarotid artery revascularization, TCAR), who are 65 years or older were included in the study. VQI Vascular Implant Surveillance and Interventional Outcomes Network (VISION) Medicare-linked database was used to obtain long-term procedure-specific outcomes. Primary endpoints were 3-year death, stroke, and reintervention. We performed propensity matching between patients with prior radiation and those without. Kaplan-Meier analysis and a multivariate logistic regression model were used to analyze the outcome variables. A total of 56472 patients had undergone carotid revascularization (CEA, n=48307; TCAR, n=4593; CAS, n=3572), 1244 patients with prior radiation and 54925 patients without prior radiation. Prior radiation group was more likely to be male (71.9% vs. 60.3%, P<0.01), to receive a stent (47.5% vs. 13.5%, P<0.01), and to be on P2Y12 inhibitor (55.2% vs. 38.3%, P<0.01). Propensity matching was performed on 1223 patients (CEA, n=655; TCAR, n=292; CAS, n=287). There were no significant differences in 30-day outcomes for death, stroke, or major adverse cardiovascular events for all three procedures (Table I). The prior radiation group had higher rates of cranial nerve injury (3.7% vs. 1.8%, p = 0.04) and 90-day readmission (23.5% vs. 18.3%, p = 0.01) after CEA. For long-term outcomes, prior radiation significantly increased mortality risk for CEA and CAS (HR 1.77, CI [1.38 - 2.27] and 1.56, CI [1.02 - 2.36], respectively). The 3-year risk of stroke for CEA in radiated patients was also significantly higher (HR 1.47, CI [1.03 - 2.09]) compared to non-radiated patients. Prior radiation did not significantly affect death and stroke in patients undergoing TCAR. Prior radiation also did not impact the rates of short and long-term reintervention after CEA, CAS, or TCAR. Prior head and neck radiation significantly increases the risk for mortality and stroke for CEA and the risk for mortality after CAS. Long-term outcomes for TCAR are not significantly affected by prior radiation. TCAR may be the preferred treatment modality for patients with radiation-induced carotid stenosis.

Determinants of Mortality and Mid-Term Outcomes After Transcarotid Artery Revascularization and Transfemoral Carotid Artery Stenting.

The potential benefit of transcarotid artery revascularization (TCAR) over transfemoral carotid artery stenting (tfCAS) has been studied in the perioperative period with lower rates of stroke and death; however, data on mid-term outcomes are limited. We aimed to evaluate 3-year outcomes after TCAR and tfCAS and determine the primary predictors of 30-day and 1-year mortality following TCAR. Data from the Vascular Quality Initiative for patients undergoing TCAR or tfCAS from January 2016 to December 2022 were analyzed. 1:1 propensity score matching using the nearest-neighbor method was used to adjust baseline demographics and clinical characteristics. Kaplan-Meier survival analysis and Cox Proportional Hazard Regression were used to evaluate long-term outcomes. Iterative stepwise multiple logistic regression analysis and Cox Proportional Hazard Regression were used to identify predictors of 30-day and 1-year mortality, respectively, based upon preoperative, intraoperative, and postoperative factors. A total of 70 237 patients were included in analysis (TCAR=58.7%, tfCAS=41.3%). Transcarotid artery revascularization patients were older and had higher rates of comorbid conditions and high-risk medical and anatomic features than tfCAS patients. Propensity score matching yielded 22 322 pairs with no major differences between groups except that TCAR patients were older (71.6 years vs 70.8 years). At 3 years, TCAR was associated with a 24% reduction in hazard of death compared with tfCAS (hazard ratio [HR]=0.76, 95% confidence interval [CI]=0.71-0.82, p<0.001), for both symptomatic and asymptomatic patients. This survival advantage was established in the first 6 months (HR=0.59, 95% CI=0.53-0.62, p<0.001), with no difference in mortality risk from 6 months to 36 months (HR=0.95, 95% CI=0.86-1.05, p=0.31). Transcarotid artery revascularization was also associated with decreased hazard for 3-year stroke (HR=0.81, 95% CI=0.66-0.99, p=0.04) and stroke or death (HR=0.81, 95% CI=0.76-0.87, p<0.001) compared with tfCAS. The top predictors for 30-day and 1-year mortality were postoperative complications. The primary independent predictor was the occurrence of postoperative stroke. Transcarotid artery revascularization had a sustained mid-term survival advantage associated over tfCAS, with the benefit being established primarily within the first 6 months. Notably, our findings highlight the importance of postoperative stroke as the primary independent predictor for 30-day and 1-year mortal. The ongoing debate over the superiority of TCAR compared to tfCAS and CEA has been limited by a lack of comparative studies examining the impact of pre-operative symptoms on outcomes. Furthermore, data are scarce on mid-term outcomes for TCAR beyond the perioperative period. As a result, it remains uncertain whether the initial benefits of stroke and death reduction observed with TCAR over tfCAS persist beyond one year. Our study addresses these gaps in the literature, offering evidence to enable clinicians to assess the efficacy of TCAR for up to three years. Additionally, our study seeks to identify risk factors for postoperative mortality following TCAR, facilitating optimal patient stratification.

Clinical outcomes of transcarotid artery revascularization vs carotid endarterectomy from a large single-center experience

BackgroundTranscarotid artery revascularization (TCAR) has been practiced as an alternative for both carotid endarterectomy (CEA) and transfemoral carotid artery stenting, specifically in high-risk patients. More recently, the Centers for Medicare and Medicaid Services expanded coverage for TCAR in standard surgical risk patients if done within the Society for Vascular Surgery Vascular Quality Initiative TCAR surveillance project. A few registry studies (primarily from the Society for Vascular Surgery Vascular Quality Initiative) compared the early and up to 1-year outcomes of TCAR vs CEA or transfemoral carotid artery stenting. There is no large single-center study that reported late clinical outcomes. The present study compares intermediate clinical outcomes of TCAR vs CEA. MethodsThis study retrospectively analyzed collected data from TCAR surveillance project patients enrolled in our institution and compare it with CEA patients done by the same providers at the same time period. The primary outcome was combined perioperative stroke/death and late stroke/death. Secondary outcomes included combined stroke, death, and myocardial infarction, cranial nerve injury (CNI), and bleeding. Propensity matching was done to analyze outcome. Kaplan-Meier analysis was used to estimate freedom from stroke, stroke/death, and ≥50% and ≥80% restenosis. ResultsWe analyzed 646 procedures (637 patients) (404 CEA, 242 TCAR). There was no significant difference in the indications for carotid intervention. However, TCAR patients had more high-risk criteria, including hypertension, coronary artery disease, congestive heart failure, and renal failure. There was no significant differences between CEA vs TCAR in 30-day perioperative stroke (1% vs 2%), stroke/death rate (1% vs 3%; P = .0849), or major hematomas (2% vs 2%). The rate of CNI was significantly different (5% for CEA vs 1% for TCAR; P = .0138). At late follow-up (2 years), the rate of stroke was 1% vs 4% (P = .0273), stroke/death 8% vs 15% (P = .008), ≥80 % restenosis 0.5% vs 3% (P = .0139) for CEA patients vs TCAR patients, respectively. After matching 242 CEAs and 242 TCARs, the perioperative stroke rate was 1% for CEA vs 2% for TCAR (P = .5037), the stroke/death rate was 2% vs 3% (P = .2423), and the CNI rate was 3% vs 1% (P = .127). At late follow-up, rates of stroke were 1% for CEA vs 4% for TCAR (P = .0615) and stroke/death were 8% vs 15% (P = .0345). The rate of ≥80% restenosis was 0.9% for CEA vs 3% for TCAR (P = .099). The rates of freedom from stroke at 6, 12, 18, and 24 months for CEA vs TCAR were 99%, 99%, 99%, and 99% vs 97%, 95%, 93% and 93%, respectively (P = .0806); stroke/death were 94%, 90%, 87%, and 86% vs 93%, 87%, 76%, and 75%, respectively (P = .0529); and ≥80% restenosis were 100%, 99%, 98%, and 98% vs 97%, 95%, 93%, and 93%, respectively (P = .1132). ConclusionsIn a propensity-matched analysis, both CEA and TCAR have similar perioperative clinical outcomes. However, CEA was superior to TCAR for the rates of late stroke/death and had a somewhat lower rate of ≥80% restenosis at 2 years, but this difference was not statistically significant.

Learning curve of transfemoral carotid artery stenting in the vascular quality initiative registry

ObjectiveWith the recent expansion of the Centers for Medicare and Medicaid Services coverage, transfemoral carotid artery stenting (tfCAS) is expected to play a larger role in the management of carotid disease. Existing research on the tfCAS learning curve, primarily conducted over a decade ago, may not adequately describe the current effect of physician experience on outcomes. Because approximately 30% of perioperative strokes/deaths post-CAS occur after discharge, appropriate thresholds for in-hospital event rates have been suggested to be <4% for symptomatic and <2% for asymptomatic patients. This study evaluates the tfCAS learning curve using Vascular Quality Initiative (VQI) data. MethodsWe identified VQI patients who underwent tfCAS between 2005 and 2023. Each physician's procedures were chronologically grouped into 12 categories, from procedure counts 1-25 to 351+. The primary outcome was in-hospital stroke/death rate; secondary outcomes were in-hospital stroke/death/myocardial infarction (MI), 30-day mortality, in-hospital stroke/transient ischemic attack (stroke/TIA), and access site complications. The relationship between outcomes and procedure counts was analyzed using the Cochran-Armitage test and a generalized linear model with restricted cubic splines. Our results were then validated using a generalized estimating equations model to account for the variability between physicians. ResultsWe analyzed 43,147 procedures by 2476 physicians. In symptomatic patients, there was a decrease in rates of in-hospital stroke/death (procedure counts 1-25 to 351+: 5.2%-1.7%), in-hospital stroke/death/MI (5.8%-1.7%), 30-day mortality (4.6%-2.8%), in-hospital stroke/TIA (5.0%-1.1%), and access site complications (4.1%-1.1%) as physician experience increased (all P values < .05). The in-hospital stroke/death rate remained above 4% until 235 procedures. Similarly, in asymptomatic patients, there was a decrease in rates of in-hospital stroke/death (2.1%-1.6%), in-hospital stroke/death/MI (2.6%-1.6%), 30-day mortality (1.7%-0.4%), and in-hospital stroke/TIA (2.8%-1.6%) with increasing physician experience (all P values <.05). The in-hospital stroke/death rate remained above 2% until 13 procedures. ConclusionsIn-hospital stroke/death and 30-day mortality rates after tfCAS decreased with increasing physician experience, showing a lengthy learning curve consistent with previous reports. Given that physicians' early cases may not be included in the VQI, the learning curve was likely underestimated. Nevertheless, a substantially high rate of in-hospital stroke/death was found in physicians' first 25 procedures. With the recent Centers for Medicare and Medicaid Services coverage expansion for tfCAS, a significant number of physicians would enter the early stage of the learning curve, potentially leading to increased postoperative complications.

An analysis of the recommendations of the 2022 Society for Vascular Surgery clinical practice guidelines for patients with asymptomatic carotid stenosis

ObjectivePatients with asymptomatic carotid artery stenosis currently account for the majority of carotid interventions performed in the United States; therefore, the following article will review the 2022 Society for Vascular Surgery (SVS) clinical practice guidelines perspective in treating patient with asymptomatic carotid stenosis. MethodsA systemic review and meta-analysis were conducted by the evidence practice center of the Mayo Clinic using a specified population, intervention, comparison, outcome (PICO) framework. ResultsBased on published randomized trials and related supporting evidence, the following were noted: the SVS recommends that patients with asymptomatic ≥70% stenosis can be considered for carotid endarterectomy (CEA), transcarotid artery revascularization (TCAR), or transfemoral carotid artery stenting (TFCAS) for the reduction of long-term risk of stroke, provided the patient has a life expectancy of 3 to 5 years with risk of perioperative stroke and death not exceeding 3%. The type of carotid intervention should be based on the presence or absence of high-risk criteria for each specified intervention. Data from CREST, ACT, and the Vascular Quality Initiative suggest that certain properly selected asymptomatic patients can be treated with carotid stenting with equivalent outcome to CEA in the hands of experienced interventionalists. The institutions and operator performing carotid stenting must exhibit expertise sufficient to meet the established American Heart Association guidelines for treatment of patient with asymptomatic carotid stenosis (ie, combined stroke/death rate of less than 3%). ConclusionsSVS recommends that low surgical risk patients with asymptomatic carotid stenosis of ≥70% to be treated with CEA with best medical therapy over medical therapy alone for the long-term prevention of stroke/death (GRADE 1B). Carotid intervention should also be based on the presence or absence of high-risk criteria for each specified intervention (ie, CEA, TCAR, and TFCAS).

Duplex ultrasound and cross-sectional imaging in carotid artery occlusion diagnosis

ObjectiveInvestigations into imaging modalities in the diagnosis of extracranial carotid artery occlusion (CAO) have raised questions about the inter-modality comparability of duplex ultrasound (DUS) and cross-sectional imaging (CSI). This study examines the relationship between DUS and CSI diagnoses of extracranial CAO. MethodsThis single-institution retrospective analysis studied patients with CAO diagnosed by DUS from 2010 to 2021. Patients were identified in our office-based accredited vascular laboratory database. Imaging and clinical data was obtained via our institutional electronic medical record. Primary outcome was discrepancy between DUS and CSI modalities. Secondary outcomes included incidence of stroke and intervention subsequent to CAO diagnosis. ResultsOf our 140-patient cohort, 95 patients (67.9%) had DUS follow-up (mean, 42.7 ± 31.3 months). At index duplex, 68.0% of individuals (n = 51) were asymptomatic. Seventy-five patients (53.6%) had CSI of the carotids after DUS CAO diagnosis; 18 (24%) underwent magnetic resonance imaging and 57 (76%) underwent computed tomography. Indications for CSI included follow-up of DUS findings of carotid stenosis/occlusion (44%), stroke/transient ischemic attack (16%), other symptoms (12%), preoperative evaluation (2.7%), unrelated pathology follow-up (9.3%), and outside institution imaging with unavailable indications (16%). When comparing patients with CSI and those without, there were no differences with regard to symptoms at diagnosis, prior neck interventions, or hypertension. There was a significant difference between cross-sectionally imaged and non-imaged patients in anti-hypertensive medications (72% vs 53.8%; P = .04). Despite initial DUS diagnoses of carotid occlusion, 10 patients (13.3%) ultimately had CSI indicating patent carotids. Four of these 10 patients had stenoses of ∼99% (with 1 string sign), four of 70% to 99%, one of 50% to 69%, and one of less than 50% on CSI. The majority of patients (70%) had CSI within 1 month of the index ultrasound. There were no significant relationships between imaging discrepancies and body mass index, heart failure, upper body edema, carotid artery calcification, and neck hardware. Eight individuals (10.7%) underwent ipsilateral revascularization; 62.5% (n = 5) were carotid endarterectomy procedures, and the remaining three procedures were a transcervical carotid revascularization, subclavian to internal carotid artery bypass, and transfemoral carotid artery stenting. Eight patients (10.7%) underwent contralateral revascularization, with the same distribution of procedures as those ipsilateral to occlusions. Two of the 10 patients with discrepancies underwent carotid endarterectomy, and one underwent carotid stenting. ConclusionsIn our experience, duplex diagnosis of CAO is associated with a greater than 10% discordance when compared with CSI. These patients may benefit from closer surveillance as well as confirmatory computed tomography or magnetic resonance angiography. Further work is needed to determine the optimal diagnostic modality for CAO.

Safety of Tailored Transfemoral Carotid Artery Stenting for Symptomatic Elderly Patients: A Single Center Observational Study

Transfemoral carotid artery stenting (TFCAS) in symptomatic elderly patients (≥70 years old) may have a high periprocedural stroke rate. This study was performed to examine whether tailored TFCAS for symptomatic elderly patients is as safe as that for symptomatic nonelderly patients. The subjects were 185 patients with symptomatic internal carotid artery stenosis. Tailored TFCAS including postoperative management was performed based on preoperative examinations of vascular anatomy, plaque imaging, platelet aggregation activity, and cerebral hemodynamic impairment. The major 30-day perioperative stroke rates were examined. The patients included 51 (27.6%) <70 (group Y) and 134 (72.4%) ≥70 (group E) years old. Group E included significantly more cases with an elongated aortic arch, tortuous target lesion, and longer plaques (all P < 0.05). Among all cases, 181 (97.8%) procedures were performed as per preoperative planning. Group E had more frequent use of a proximal embolic protection device and a closed-cell or dual-layer micromesh stent (all P < 0.05). Seven patients (3.8%) had major stroke. Rates of major ischemic stroke (2.0% vs. 3.0%, P= 1.00) and intracranial hemorrhage (2.0% vs. 0.8%, P= 0.48) were low and did not differ significantly between groups Y and E. Symptomatic elderly patients have several unfavorable factors. However, tailored TFCAS for each patient based on preoperative examinations in symptomatic elderly patients may be as safe as that in symptomatic nonelderly patients.

Abstract 16929: Defining Thresholds for Meaningful 30-day Health Status Changes Following Transfemoral Carotid Artery Stenting

Introduction: Carotid artery stenosis treatment trials have focused on clinical endpoints such as stroke, death, and MI, but evidence of carotid revascularization’s impact on health status is limited. This study aims to establish minimal clinically important differences (MCIDs) to assess clinical improvement or worsening from the perspectives of patients with carotid artery stenosis undergoing transfemoral carotid artery stenting (TF-CAS). Methods: We studied patients in the multicenter Stenting and Angioplasty with Protection in Patients at High Risk for Endarterectomy (SAPPHIRE) registry who underwent TF-CAS between 2010 and 2014 and who completed either the EQ-5D-3L or SF-36, two generic health-related quality-of-life surveys. Distribution-based MCIDs were calculated as 0.5 standard deviations for 30-day changes in health status scores post-TF-CAS for the EQ-5D-3L index value and visual analog scale (VAS) subscales and the SF-36 mental and physical component summary (MCS and PCS) subscales. We then stratified this analysis by symptom status (presence or abscence of prior stroke or TIA). Results: The study included 3,930 patients (27.7% symptomatic) who completed the EQ-5D-3L and 3,018 (30.5% symptomatic) who completed the SF-36. The MCIDs for the overall cohorts were 0.09, 11.02, 4.73, and 5.39 for the EQ-5D-3L index value, EQ-5D-3L VAS, SF-36 MCS, and SF-36 PCS, respectively. All MCIDs are summarized in Table 1. The MCIDs for each subscale were similar between asymptomatic and symptomatic subpopulations. Conclusions: Distribution-based thresholds for improvement and worsening of health status in patients undergoing TF-CAS were established for commonly-used generic health status instruments. These reference values can be used in both symptomatic and asymptomatic disease and will be important for interpreting future trial results focusing on the benefit of TF-CAS from patients’ perspectives.

Outcomes following carotid revascularization for stroke stratified by Modified Rankin Scale and time of intervention

ObjectivesThe relationship between baseline Modified Rankin Scale (mRS) in patients with prior stroke and optimal timing of carotid revascularization is unclear. Therefore, we evaluated the timing of transfemoral carotid artery stenting (tfCAS), transcarotid artery revascularization (TCAR), and carotid endarterectomy (CEA) after prior stroke, stratified by preoperative mRS. MethodsWe identified patients with recent stroke who underwent tfCAS, TCAR, or CEA between 2012 and 2021. Patients were stratified by preoperative mRS (0-1, 2, 3-4, or 5) and days from symptom onset to intervention (time to intervention; ≤2 days, 3-14 days, 15-90 days, and 91-180 days). First, we performed univariate analyses comparing in-hospital outcomes between separate mRS or time-to-intervention cohorts for all carotid intervention methods. Afterward, multivariable logistic regression was used to adjust for demographics and comorbidities across groups, and outcomes between the various intervention methods were compared. Primary outcome was the in-hospital stroke/death rate. ResultsWe identified 4260 patients who underwent tfCAS, 3130 patients who underwent TCAR, and 20,012 patients who underwent CEA. Patients were most likely to have minimal disability (mRS, 0-1 [61%]) and least likely to have severe disability (mRS, 5 [1.5%]). Patients most often underwent revascularization in 3 to 14 days (45%). Across all intervention methods, increasing preoperative mRS was associated with higher procedural in-hospital stroke/death (all P < .03), whereas increasing time to intervention was associated with lower stroke/death rates (all P < .01). After adjustment for demographics and comorbidities, undergoing tfCAS was associated with higher stroke/death compared with undergoing CEA (adjusted odds ratio, 1.6; 95% confidence interval, 1.3-1.9; P < .01) or undergoing TCAR (adjusted odds ratio, 1.3; 95% confidence interval, 1.0-1.8; P = .03). ConclusionsIn patients with preoperative stroke, optimal timing for carotid revascularization varies with stroke severity. Increasing preoperative mRS was associated with higher procedural in-hospital stroke/death rates, whereas increasing time to-intervention was associated with lower stroke/death rates. Overall, patients undergoing CEA were associated with lower in-hospital stroke/deaths. To determine benefit for delayed intervention, these results should be weighed against the risk of recurrent stroke during the interval before intervention.

Modality-specific outcomes of patients undergoing carotid revascularization in the setting of recent myocardial infarction

ObjectiveRecent myocardial infarction (MI) represents a real challenge in patients requiring any vascular procedure. There is currently a lack of data on the effect of preoperative MI on the outcomes of carotid revascularization methodology (carotid enterectomy [CEA], transfemoral carotid artery stenting [TFCAS], or transcarotid artery revascularization [TCAR]). This study looks to identify modality-specific outcomes for patients with recent MI undergoing carotid revascularization. MethodsData was collected from the Vascular Quality Initiative (2016-2022) for patients with carotid stenosis in the United States and Canada with recent MI (<6 months) undergoing CEA, TFCAS, or TCAR. In-hospital outcomes after TFCAS vs CEA and TCAR vs CEA were compared. TCAR vs TFCAS were compared in a secondary analysis. We used logistic regression models to compare the outcomes of these three procedures in patients with recent MI, adjusting for potential confounders. Primary outcomes included 30-day in-hospital rates of stroke, death, and MI. Secondary outcomes included stroke/death, stroke/death/MI, postoperative hypertension, postoperative hypotension, prolonged length of stay (>2 days), and 30-day mortality. ResultsThe final cohort included 1217 CEA (54.2%), 445 TFCAS (19.8%), and 584 TCAR (26.0%) cases. Patients undergoing CEA were more likely to have prior coronary artery bypass graft/percutaneous coronary intervention and to use anticoagulant. Patients undergoing TFCAS were more likely to be symptomatic, have prior congestive heart failure, chronic obstructive pulmonary disease, chronic kidney disease, and undergo urgent operations. Patients undergoing TCAR were more likely to have higher rates of American Society of Anesthesiologists class IV to V, P2Y12 inhibitor, and protamine use. In the univariate analysis, CEA was associated with a lower rate of ipsilateral stroke (P = .079), death (P = .002), and 30-day mortality (P = .007). After adjusting for confounders, TFCAS was associated with increased risk of stroke/death (adjusted odds ratio [aOR], 2.69; 95% confidence interval [CI], 1.36-5.35; P = .005) and stroke/death/MI (aOR, 1.67; 95% CI, 1.07-2.60; P = .025) compared with CEA. However, TCAR had similar outcomes compared with CEA. Both TFCAS and TCAR were associated with increased risk of postoperative hypotension (aOR, 1.62; 95% CI, 1.18-2.23; P = .003 and aOR, 1.74; 95% CI, 1.31-2.32; P ≤ .001, respectively) and decreased risk of postoperative hypertension (aOR, 0.59; 95% CI, 0.36-0.95; P = .029 and aOR, 0.50; 95% CI, 0.36-0.71; P ≤ .001, respectively) compared with CEA. ConclusionsAlthough recent MI has been established as a high-risk criterion for CEA and an approved indication for TFCAS, this study showed that CEA is safer in this population with lower risk of stroke/death and stroke/death/MI compared with TFCAS. TCAR had similar stroke/death/MI outcomes in comparison to CEA in patients with recent MI. Further prospective studies are needed to confirm our findings.

Impact of Race on Perioperative Outcomes Following Carotid Endarterectomy, Transfemoral Carotid Artery Stenting, and Transcarotid Artery Revascularization

Impact of Race on Perioperative Outcomes Following Carotid Endarterectomy, Transfemoral Carotid Artery Stenting, and Transcarotid Artery Revascularization

Neck radiation is not associated with increased risk of perioperative adverse events after transcarotid artery revascularization or transfemoral carotid artery stenting

ObjectiveIt is unclear whether patients with prior neck radiation therapy (RT) are at high risk for carotid artery stenting (CAS). We aimed to delineate 30-day perioperative and 3-year long-term outcomes in patients treated for radiation-induced stenotic lesions by the transfemoral carotid artery stenting (TFCAS) or transcarotid artery revascularization (TCAR) approach to determine comparative risk and to ascertain the optimal intervention in this cohort. MethodsData were extracted from the Vascular Quality Initiative CAS registry for patients with prior neck radiation who had undergone either TCAR or TFCAS. The Student t-test and the χ2 test were used to compare baseline patient characteristics. Multivariable logistic regression and Cox Hazard Proportional analysis were used to compare perioperative and long-term differences between patients with and without prior neck radiation following TCAR and TFCAS. Kaplan-Meier estimator was used to determine the incidence of 3-year adverse events. ResultsA total of 72,656 patients (TCAR, 40,879; TFCAS, 31,777) were included in the analysis. Of these, 4151 patients had a history of neck radiation. Patients with a history of neck radiation were more likely to be younger, white, and have fewer comorbidities than patients with no neck radiation history. After adjustment for confounding factors, there was no difference in relative risk of 30-day perioperative stroke (P = .11), death (P = .36), or myocardial infarction (MI) (P = .61) between TCAR patients with or without a history of neck radiation. The odds of stroke/death (P = .10) and stroke/death/MI (P = .07) were also not statistically significant. In patients with prior neck radiation, TCAR had lower odds for in-hospital stroke/death/MI (odds ratio, 0.59; 95% confidence interval [CI], 0.35-0.99; P = .05) and access site complications than TFCAS. At year 3, patients with prior neck radiation had an increased hazard for mortality after TCAR (hazard ratio [HR], 1.24; 95% CI, 1.02-1.51; P = .04) and TFCAS (HR, 1.33; 95% CI, 1.12-1.58; P = .001). Patients with prior neck radiation also experienced an increased hazard for reintervention after TCAR (HR, 2.16; 95% CI, 1.45-3.20; P < .001) and TFCAS (HR, 1.67; 95% CI, 1.02-2.73; P<.001). ConclusionsPatients with prior neck radiation had a similar relative risk of 30-day perioperative adverse events as patients with no neck radiation after adjustment for baseline demographics and disease characteristics. In these patients, TCAR was associated with reduced odds of perioperative stroke/death/MI as compared with TFCAS. However, patients with prior neck radiation were at increased risk for 3-year mortality and reintervention.

Adoption and Diffusion of Transcarotid Artery Revascularization in Contemporary Practice.

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. 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. 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). 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.

Intraoperative fusion imaging during transcarotid artery revascularization.

Transcarotid artery revascularization (TCAR) with reverse-flow neuroprotection has emerged as an alternative to transfemoral carotid artery stenting and carotid endarterectomy. However, it requires fluoroscopic guidance, exposing the patient and surgeon to radiation. Although fusion-guided endovascular aneurysm repair has been demonstrated to significantly decrease this radiation risk, not much is known about similar outcomes for TCAR. The purpose of this study is to evaluate the outcomes at a single institution using fusion-guided imaging during TCAR compared with regional TCAR cases in the Vascular Quality Initiative (VQI) registry without fusion imaging. A retrospective analysis was conducted of data collected from all patients undergoing TCAR with fusion-guided imaging (TCAR-F) at our hospital and patients undergoing TCAR alone within the VQI database. The primary outcomes included the total operative time, dose area product, fluoroscopy time, contrast usage, and flow-reversal time. The demographics and preoperative risk factors were also assessed in both groups. Continuous outcomes were compared using the Welch t test. Categorical outcomes were compared using the Fisher exact test. A total of 30 TCAR-F cases (January 2019 to May 2022) at our institution were compared against the regional VQI dataset (n= 2535). The TCAR-F cases had a lower dose area product (5.67 vs 93.1Gycm2; P< .0001), shorter fluoroscopy time (8.07 vs 16.4minutes; P< .0001), and less contrast usage (13.49 vs 76.7mL; P< .0001) compared with the regional averages of the same. The TCAR-F cases had a longer total operative time (117.3 vs 80.9minutes; P< .0001) and flow-reversal time (14.4 vs 11.7minutes; P= .025) compared with the regional cases. The results from this pilot study comparing TCAR-F patients at a single institution with VQI regional TCAR patients suggest that TCAR-F cases use less radiation and contrast compared with TCAR without fusion imaging. Fusion-guided imaging might provide radiation protection to both patients and surgeons and decrease contrast usage for the patient.

Long-term outcomes of carotid endarterectomy vs transfemoral carotid stenting in a Medicare-matched database

BackgroundCarotid endarterectomy (CEA) is associated with lower risk of perioperative stroke compared with transfemoral carotid artery stenting (TFCAS) in the treatment of carotid artery stenosis. However, there is discrepancy in data regarding long-term outcomes. We aimed to compare long-term outcomes of CEA vs TFCAS using the Medicare-matched Vascular Quality Initiative Vascular Implant Surveillance and Interventional Outcomes Network database. MethodsWe assessed patients undergoing first-time CEA or TFCAS in Vascular Quality Initiative Vascular-Vascular Implant Surveillance and Interventional Outcomes Network from January 2003 to December 2018. Patients with prior history of carotid revascularization, nontransfemoral stenting, stenting performed without distal embolic protection, multiple or nonatherosclerotic lesions, or concomitant procedures were excluded. The primary outcome of interest was all-cause mortality, any stroke, and a combined end point of death or stroke. We additionally performed propensity score matching and stratification based on symptomatic status. ResultsA total of 80,146 carotid revascularizations were performed, of which 72,615 were CEA and 7531 were TFCAS. CEA was associated with significantly lower risk of death (57.8% vs 70.4%, adjusted hazard ratio [aHR], 0.46; 95% confidence interval [CI], 0.41-0.52; P < .001), stroke (21.3% vs 26.6%; aHR, 0.63; 95% CI, 0.57-0.69; P < .001) and combined end point of death and stroke (65.3% vs 76.5%; HR, 0.49; 95% CI, 0.44-0.55; P < .001) at 10 years. These findings were reflected in the propensity-matched cohort (combined end point: 34.6% vs 46.8%; HR, 0.53; 95% CI, 0.46-0.62) at 4 years, as well as stratified analyses of combined end point by symptomatic status (asymptomatic: 63.2% vs 74.9%; HR, 0.49; 95% CI, 0.43-0.58; P < .001; symptomatic: 69.9% vs 78.3%; HR, 0.51; 95% CI, 0.45-0.59; P < .001) at 10 years. ConclusionsIn this analysis of North American real-world data, CEA was associated with greater long-term survival and fewer strokes compared with TFCAS. These findings support the continued use of CEA as the first-line revascularization procedure.

Carotid artery dissections from transcarotid artery revascularization as reported by the Food and Drug Administration.

Transcarotid artery revascularization (TCAR) is a hybrid procedure that allows reversal of blood flow away from the brain while placing a stent through direct surgical access of the common carotid artery. It has been shown to have a lower risk of perioperative stroke compared with any prospective trial of transfemoral carotid artery stenting. However, intraoperative injuries related to the procedure and its management are not well characterized. One of the intraoperative complications seen in TCAR is iatrogenic carotid artery dissection (CD). We aim to add qualitative insight in further characterizing CDs and its management in this emerging technology. The Food and Drug Administration (FDA) maintains the Manufacturer and User Facility Device Experience (MAUDE) database for surveillance of all medical devices approved for use. This database was queried for all cases associated with Silk Road Medical's ENROUTE Transcarotid Neuroprotection System from September 2016 to October 2020. Case narratives related to CD were individually analyzed to determine time of injury (intraoperative, recovery, and post-discharge follow-up). CD reporting was further analyzed for the associated procedural event at the time of injury, number of access attempts to CD repair, and type of CD repair. Reports associated with CD repair were further categorized into endovascular repair and open surgical repair. Of the 115 unique adverse events in the database, there were 58 CDs. Most were identified intraoperatively (n = 55), while three were incidentally found postoperatively. Overall, sheath placement was the most common procedural event attributed to CD (N = 34). There was adequate narrative information about CD repair in 54 patients. Intraoperative repair was performed in 52 cases and two were repaired after post-discharge follow-up imaging was performed.Among CDs that did not require additional access to engage the true lumen, the proportion of endovascular repair (62.5%) was significantly higher (p = .044) compared to the proportion of open surgical repair (37.5%). However, the proportion of open surgical repair (75%) was significantly higher than the proportion of endovascular repair (25%) in CDs with persistent failure to engage the true lumen despite ≥2 access attempts (p = .039). CD is the most common injury related to TCAR as reported on MAUDE. The most commonly reported procedural event associated with CD was sheath placement. The rate of intraoperative endovascular and open surgical CD repair was associated with whether the access to the true lumen of the carotid artery required additional access attempts or not. This should add qualitative insight among the vascular surgery community regarding intraoperative management of CDs from a TCAR procedure.

Endovascular stenting techniques for blunt carotid injury.

While methods of endovascular carotid artery stenting have improved over time, concerns surrounding the safety and efficacy of stenting for blunt carotid injury (BCI) remain. This study aims to present our approach to carotid artery stenting (CAS) by incorporating new technologies such as flow-diverting stents and circuits. There is no robust evidence to support routine carotid artery stenting; however, there are several therapeutic options and approaches for treating BCI that currently require an individualized approach. Endovascular stenting and specific stent selection are largely dictated by the disease process the surgeon intends to treat. We will discuss patient selection, medical management, and the most common revascularization techniques, including transfemoral stenting, trans-carotid arterial revascularization using flow reversal, and stent-assisting coiling. It must be stressed that endovascular intervention is not an alternative to or preclusive of antithrombotic or anticoagulant therapy. In the setting of BCI, transfemoral CAS is most appropriate in patients who are symptomatic, have a rapidly progressing or large lesion, and do not have a soft thrombus present due to risk of embolism. Unlike transfemoral CAS, TCAR offers an elegant solution for embolic protection when patients have a soft thrombus present. In the case of a large pseudoaneurysm, we perform stent-assisted coiling. We practice selective endovascular intervention, stenting lesions that are flow-limiting or have large or rapidly expanding pseudoaneurysms, and only in patients for whom anticoagulation and antiplatelet agents are not contraindicated. As technology and investigation progress, the concerns regarding the safety and the role of endovascular intervention in the treatment of BCI will be more clearly defined.

Propensity-Score Matched Analysis of Three Years Survival of Trans Carotid Artery Revascularization Versus Carotid Endarterectomy in the Vascular Quality Initiative Medicare-Linked Database.

Carotid endarterectomy (CEA) remains the gold standard procedure for carotid revascularization. Transfemoral carotid artery stenting (TFCAS) was introduced as a minimally invasive alternative procedure in patients who are at high risk for surgery. However, TFCAS was associated with an increased risk of stroke and death compared to CEA. Transcarotid artery revascularization (TCAR) has outperformed TFCAS in several prior studies and has shown similar perioperative and 1-year outcomes compared with CEA. We aimed to compare the 1-year and 3-year outcomes of TCAR versus CEA in the Vascular Quality Initiative (VQI)-Medicare-Linked [Vascular Implant Surveillance and Interventional Outcomes Network (VISION)] database. The VISION database was queried for all patients undergoing CEA and TCAR between September 2016 to December 2019. The primary outcome was 1-year and 3-year survival. One-to-one propensity-score matching (PSM) without replacement was used to produce 2 well-matched cohorts. Kaplan-Meier estimates, and Cox regression was used for analyses. Exploratory analyses compared stroke rates using claims-based algorithms for comparison. A total of 43,714 patients underwent CEA and 8089 patients underwent TCAR during the study period. Patients in the TCAR cohort were older and were more likely to have severe comorbidities. PSM produced two well-matched cohorts of 7351 pairs of TCAR and CEA. In the matched cohorts, there were no differences in 1-year death [hazard ratio (HR)=1.13; 95% CI, 0.99-1.30; P =0.065]. At 3-years, TCAR was associated with slight increased risk of death (HR=1.16; 95% CI, 1.04-1.30; P =0.008). When stratifying by initial symptomatic presentation, the increased 3-year death associated with TCAR persisted only in symptomatic patients (HR=1.33; 95% CI, 1.08-1.63; P =0.008). Exploratory analyses of postoperative stroke rates using administrative sources suggested that validated measures of claims-based stroke ascertainment are necessary. In this large multi-institutional PSM analysis with robust Medicare-linked follow-up for survival analysis, the rate of death at 1 year was similar in TCAR and CEA regardless of symptomatic status. The slight increase in the risk of 3-year death in symptomatic patients undergoing TCAR is likely confounded by more severe comorbidities despite matching. A randomized controlled trial comparing TCAR to CEA is necessary to further determine the role of TCAR in standard-risk patients requiring carotid revascularization.

Risk Factors for Cerebral Hyperperfusion Syndrome following Carotid Revascularization

Cerebral hyperperfusion syndrome (CHS) is a rare but known complication of carotid revascularization that can result in severe postoperative disability and death. CHS is a well-described sequela of carotid endarterectomy (CEA) and, more recently, of transfemoral carotid artery stenting (TFCAS), but its incidence after transcarotid artery revascularization (TCAR) has not been delineated. The aims of this study were to determine the impact of procedure type (CEA versus TCAR versus TFCAS) on the development of CHS as well as to identify perioperative risk factors associated with CHS. The Society for Vascular Surgery Vascular Quality Initiative was queried for patients aged ≥18years who underwent CEA, TCAR, or TFCAS from 2015-2021. Emergent procedures were excluded. The primary outcome was postoperative development of CHS, defined as the presence of postoperative seizures, intracerebral hemorrhage due to hyperperfusion, or both. Bivariate and multivariable logistic regression analyses were performed to identify factors associated with CHS. 156,003 procedures were included (72.7% CEA, 12.4% TCAR, and 14.9% TFCAS). The incidence of CHS after CEA, TCAR, and TFCAS were 0.15%, 0.18%, and 0.53%, respectively. There was no significant difference in risk of CHS after TFCAS compared to CEA (odds ratio [OR]: 1.21; 95% confidence interval [CI] 0.76-1.92; P=0.416), nor was there a difference between TCAR and CEA (OR: 0.91; 95% CI 0.57-1.45; P=0.691). Perioperative risk factors associated with an increased risk of CHS included previous history of transient ischemic attack or stroke (OR: 2.50; 95% CI 1.69-3.68; P<0.0001), necessity for urgent intervention within 48hr (OR: 2.03; 95% CI 1.43-2.89; P<0.0001), treatment of a total occlusion (OR: 3.80; 95% CI 1.16-12.47; P=0.028), and need for postoperative intravenous blood pressure medication (OR: 5.45; 95% CI 3.97-7.48; P<0.0001). Age, preoperative hypertension, degree of ipsilateral stenosis less than or equal to 99%, and history of prior carotid procedures were not statistically associated with an increased risk of CHS. Discharging patients on an angiotensin-converting enzyme inhibitor or angiotensin II receptor blocker was associated with a decreased risk of developing CHS (OR: 0.47; 95% CI 0.34-0.65; P<0.0001). Compared with CEA, TCAR and TFCAS were not statistically associated with an increased risk of postoperative CHS. Patients with a previous history of transient ischemic attack or stroke, who require urgent intervention or postoperative intravenous blood pressure medication, or who are treated for a total occlusion are at a higher risk of developing CHS. Using an angiotensin-converting enzyme inhibitor/angiotensin II receptor blocker on discharge appears to be protective against CHS and should be considered for the highest risk patients.