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

OBJECTIVE: It 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. METHODS: Data 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. RESULTS: A 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). CONCLUSIONS: Patients 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.

Female and male patients have similar outcomes after transcarotid artery revascularization in prospective trials.

OBJECTIVE: Sex disparities in outcomes after carotid revascularization have long been a concern, with several studies demonstrating increased postoperative death and stroke for female patients after either carotid endarterectomy or transfemoral stenting. Adverse events after transfemoral stenting are higher in female patients, particularly in symptomatic cases. Our objective was to investigate outcomes after transcarotid artery revascularization (TCAR) stratified by patient sex hypothesizing that the results would be similar between males and females. METHODS: We analyzed prospectively collected data from the Safety and Efficacy Study for Reverse Flow Used During Carotid Artery Stenting Procedure (ROADSTER)1 (pivotal), ROADSTER2 (US Food and Drug Administration indicated postmarket), and ROADSTER Extended Access TCAR trials. All patients had verified carotid stenosis meeting criteria for intervention (≥80% for asymptomatic patients and ≥50% in patient with symptomatic disease), and were included based on anatomical or clinical high-risk criteria for carotid stenting. Neurological assessments (National Institutes of Health Stroke Scale, Modified Rankin Scale) were obtained before and within 24 hours from procedure end by an independent neurologist or National Institutes of Health Stroke Scale-certified nurse. Patients were stratified by sex (male vs female). Baseline demographics were compared using χ2 and Fisher's exact tests where appropriate; primary outcomes were combination stroke/death (S/D) and S/D/myocardial infarction (S/D/M) at 30 days, and secondary outcomes were the individual components of S/D/M. Univariate logistic regression was conducted. RESULTS: We included 910 patients for analysis (306 female [33.6%], 604 male [66.4%]). Female patients were more often <65 years old (20.6% vs 15%) or ≥80 years old (22.6% vs 20.2%) compared with males, and were more often of Black/African American ethnicity (7.5% vs 4.3%). There were no differences by sex in term of comorbidities, current or prior smoking status, prior stroke, symptomatic status, or prevalence of anatomical and/or clinical high-risk criteria. General anesthetic use, stent brands used, and procedure times did not differ by sex, although flow reversal times were longer in female patients (10.9 minutes male vs 12.4 minutes female; P = .01), as was more contrast used in procedures for female patients (43 mL male vs 48.9 mL female; P = .049). The 30-day S/D and S/D/M rates were similar between male and female patients (S/D, 2.7% male vs 1.6% female [P = .34]; S/D/M, 3.6% male vs 2.6% female [P = .41]), which did not differ when stratified by symptom status. Secondary outcomes did not differ by sex, including stroke rates at 30 days (2.2% male vs 1.6% female; P = .80), nor were differences seen with stratification by symptom status. Univariate analysis demonstrated that history of a prior ipsilateral stroke was associated with increased odds of S/D (odds ratio [OR], 4.19; P = .001) and S/D/M (OR, 2.78; P = .01), as was symptomatic presentation with increased odds for S/D (OR, 2.78; P = .02). CONCLUSIONS: Prospective TCAR trial data demonstrate exceptionally low rates of S/D/MI, which do not differ by patient sex.

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

BACKGROUND: Transcarotid 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. METHODS: This 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. RESULTS: We 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). CONCLUSIONS: In 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.

Outcomes of carotid revascularization stratified by procedure in patients with an estimated glomerular filtration rate of <30 and dialysis patients.

OBJECTIVE: Renal failure is a predictor of adverse outcomes in carotid revascularization. There has been debate regarding the benefit of revascularization in patients with severe chronic kidney disease or on dialysis. METHODS: Patients in the Vascular Quality Initiative undergoing transcarotid artery revascularization (TCAR), transfemoral carotid artery stenting (tfCAS), or CEA between 2016 and 2023 with an estimated glomerular filtration rate (eGFR) of <30 mL/min/1.73 m2 or on dialysis were included. Patients were divided into cohorts based on procedure. Additional analyses were performed for patients on dialysis only and by symptomatology. Primary outcomes were perioperative stroke/death/myocardial infarction (MI) (SDM). Secondary outcomes included perioperative death, stroke, MI, cranial nerve injury, and stroke/death. Inverse probability of treatment weighting was performed based on treatment assignment to TCAR, tfCAS, and CEA patients and adjusted for demographics, comorbidities, and preoperative symptoms. The χ2 test and multivariable logistic regression analysis were used to evaluate the association of procedure with perioperative outcomes in the weighted cohort. Five-year survival was evaluated using Kaplan-Meier and weighted Cox regression. RESULTS: In the weighted cohort, 13,851 patients with an eGFR of <30 (2506 on dialysis) underwent TCAR (3639; 704 on dialysis), tfCAS (1975; 393 on dialysis), or CEA (8237; 1409 on dialysis) during the study period. Compared with TCAR, CEA had higher odds of SDM (2.8% vs 3.6%; adjusted odds ratio [aOR], 1.27; 95% confidence interval [CI], 1.00-1.61; P = .049), and MI (0.7% vs 1.5%; aOR, 2.00; 95% CI, 1.31-3.05; P = .001). Compared with TCAR, rates of SDM (2.8% vs 5.8%), stroke (1.2% vs 2.6%), and death (0.9% vs 2.4%) were all higher for tfCAS. In asymptomatic patients CEA patients had higher odds of MI (0.7% vs 1.3%; aOR, 1.85; 95% CI, 1.15-2.97; P = .011) and cranial nerve injury (0.3% vs 1.9%; aOR, 7.23; 95% CI, 3.28-15.9; P < .001). Like in the primary analysis, asymptomatic tfCAS patients demonstrated higher odds of death and stroke/death. Symptomatic CEA patients demonstrated no difference in stroke, death, or stroke/death. Although tfCAS patients demonstrated higher odds of death, stroke, MI, stroke/death, and SDM. In both groups, the 5-year survival was similar for TCAR and CEA (eGFR <30, 75.1% vs 74.2%; aHR, 1.06; P = .3) and lower for tfCAS (eGFR <30, 75.1% vs 70.4%; aHR, 1.44; P < .001). CONCLUSIONS: CEA and TCAR had similar odds of stroke and death and are both a reasonable choice in this population; however, TCAR may be better in patients with an increased risk of MI. Additionally, tfCAS patients were more likely to have worse outcomes after weighting for symptom status. Finally, although patients with a reduced eGFR have worse outcomes than their healthy peers, this analysis shows that the majority of patients survive long enough to benefit from the potential stroke risk reduction provided by all revascularization procedures.

The effect of controlled vs uncontrolled hypertension on outcomes of carotid revascularization procedures.

BACKGROUND: Hypertension (HTN) has been implicated as a strong predictive factor for poorer outcomes in patients undergoing various vascular procedures. However, limited research is available that examines the effect of uncontrolled HTN (uHTN) on outcomes after carotid revascularization. We aimed to determine which carotid revascularization procedure yields the best outcome in this patient population. METHODS: We studied patients undergoing carotid endarterectomy (CEA), transfemoral carotid artery stenting (TFCAS), or transcarotid artery revascularization (TCAR) from April 2020 to June 2022 using data from the Vascular Quality Initiative. Patients were stratified into two groups: those with cHTN and those with uHTN. Patients with cHTN were those with HTN treated with medication and a blood pressure of <130/80 mm Hg. Patients with uHTN had a blood pressure of ≥130/80 mm Hg. Our primary outcomes were in-hospital stroke, death, myocardial infarction (MI), and 30-day mortality. Our secondary outcomes were postoperative hypotension or HTN, reperfusion syndrome, prolonged length of stay (LOS) (>1 day), stroke/death, and stroke/death/MI. We used logistic regression models for the multivariate analysis. RESULTS: A total of 34,653 CEA (uHTN, 11,347 [32.7%]), 8199 TFCAS (uHTN, 2307 [28.1%]), and 17,309 TCAR (uHTN, 4990 [28.8%]) patients were included in this study. There was no significant difference in age between patients with cHTN and patients with uHTN for each carotid revascularization procedure. However, compared with patients with cHTN, patients with uHTN had significantly more comorbidities. uHTN was associated with an increased risk of combined in-hospital stroke/death/MI after CEA (adjusted odds ratio [aOR], 1.56; 95% confidence interval [CI], 1.30-1.87; P < .001), TFCAS (aOR, 1.59; 95% CI, 1.21-2.08; P < .001), and TCAR (aOR, 1.39; 95% CI, 1.12-1.73; P = .003) compared with cHTN. Additionally, uHTN was associated with a prolonged LOS after all carotid revascularization methods. For the subanalysis of patients with uHTN, TFCAS was associated with an increased risk of stroke (aOR, 1.82; 95% CI, 1.39-2.37; P < .001), in-hospital death (aOR, 3.73; 95% CI, 2.25-6.19; P < .001), reperfusion syndrome (aOR, 6.24; 95% CI, 3.57-10.93; P < .001), and extended LOS (aOR, 1.87; 95% CI, 1.51-2.32; P < .001) compared with CEA. There was no statistically significant difference between the outcomes of TCAR compared with CEA. CONCLUSIONS: The results from this study show that patients with uHTN are at a higher risk of stroke and death postoperatively compared with patients with cHTN, highlighting the importance of treating HTN before undergoing elective carotid revascularization. Additionally, in patients with uHTN, TFCAS yields the worst outcomes, whereas CEA and TCAR proved to be safer interventions. Patients with uTHN with symptomatic carotid disease treated with CEA or TCAR have better outcomes compared with those treated with TFCAS.

Transcarotid artery revascularization outperforms transfemoral carotid artery stenting regardless of aortic arch type or degree of atherosclerosis.

OBJECTIVE: The Centers for Medicare and Medicaid Services now approve reimbursement for transfemoral carotid artery stenting (TFCAS) in the treatment of standard-risk patients with carotid artery occlusive disease. TFCAS in patients with complex aortic arch anatomy is known to be challenging with worse outcomes. Transcarotid artery revascularization (TCAR) could be a preferable alternative in these patients owing to avoiding the aortic arch and using flow reversal during stent deployment. We aim to compare the outcomes of TCAR vs TFCAS across all aortic arch types and degrees of arch atherosclerosis. METHODS: All patients undergoing carotid artery stenting between September 2016 and October 2023 were identified in the Vascular Quality Initiative database. Patients were stratified into four groups: Group A (mild atherosclerosis and type I/II arch), Group B (mild atherosclerosis and type III arch), Group C (moderate/severe atherosclerosis and type I/II arch), and Group D (moderate/severe atherosclerosis and type III arch). The primary outcome was in-hospital composite stroke or death. Analysis of variance and χ2 tests analyzed differences for baseline characteristics. Logistic regression models were adjusted for potential confounders, and backward stepwise selection was implemented to identify significant variables for inclusion in the final models. Kaplan-Meier survival estimates, log rank test, and multivariable Cox regression models analyzed hazard ratios for 1-year mortality. RESULTS: A total of 20,114 patients were included (Group A: 12,980 [64.53%]; Group B: 1175 [5.84%]; Group C: 5124 [25.47%]; and Group D: 835 [4.15%]). TCAR was more commonly performed across the four groups (72.21%, 67.06%, 74.94%, and 69.22%; P < .001). Compared with patients with mild arch atherosclerosis, patients with advanced arch atherosclerosis in Group C and Group D were more likely to be female, hypertensive, smokers, and have chronic kidney disease. Patients with type III arch in Group B and Group D were more likely to present with stroke preoperatively. On multivariable analysis, TCAR had less than one-half the risk of stroke/death and 1-year mortality compared with TFCAS in the patients with the mildest atherosclerosis and simple arch anatomy (Group A) (odds ratio [OR], 0.43; 95% confidence interval [CI], 0.31-0.61; P < .001; hazard ratio, 0.42; 95% CI, 0.32-0.57; P < .001). Group B patients with similar atherosclerosis but more complex arch anatomy had 70% lower odds of stroke/death with TCAR compared with TFCAS (OR, 0.30; 95% CI, 0.12-0.75; P = .01). Similar findings were also evident in patients with more severe atherosclerosis and simple arch anatomy (OR, 0.66; 95% CI, 0.44-0.97; P = .037). There was no significant difference in odds of stroke/death in patients with advanced arch atherosclerosis and complex arch (Group D) (OR, 0.91; 95% CI, 0.39-2.16; P = .834). CONCLUSIONS: TCAR is safer than TFCAS in patients with simple and advanced arch anatomy. This could be related to the efficiency of flow reversal vs distal embolic protection. The current Centers for Medicare and Medicaid Services decision will likely increase stroke and death outcomes of carotid stenting nationally if multidisciplinary approach and appropriate patient selection are not implemented.

Local Anesthesia and Enhanced Recovery After Transcarotid Artery Revascularization.

OBJECTIVE: Transcarotid artery revascularization (TCAR) is a minimally invasive surgical treatment for carotid artery stenosis. This study describes a ten-year institutional experience of TCAR and the concurrent development of enhanced recovery protocols. METHODS: Standardized practices were implemented at a single institution for patients undergoing TCAR. This included protocolized pre-operative imaging and medical optimization, intraoperative workflow, and post-operative care. Additionally, vascular anesthesiology protocols were established for managing local and general anesthesia. A retrospective review of patients undergoing TCAR was subsequently conducted. Data on patient demographics, procedural details, and outcomes were analyzed from a prospectively maintained institutional database. RESULTS: Across 321 patients, the median hospital stay after TCAR was 1.0 days with low-post-operative complications, most notably a 1.9% peri-operative stroke-death rate. CONCLUSIONS: Multidisciplinary collaboration is necessary to develop sustainable and effective enhanced recovery protocols. Implementation of these care pathways can improve patient outcomes and efficiency of care.

A Multi-Center Evaluation of Clopidogrel Resistance and its Role in Predicting Stent Thrombosis in Transcarotid Artery Revascularization.

OBJECTIVE: Clopidogrel resistance testing is not routine prior to Transcarotid Artery Revascularization (TCAR) and resistance rates are not well described in this setting, despite frequent use of periprocedural clopidogrel. We compared two resistance testing modalities to determine the relationship between resistance and stent outcomes. METHODS: Consecutive patients undergoing TCAR at three institutions were retrospectively identified. Clopidogrel-resistance testing results and outcomes were described. RESULTS: A total of 210 patients underwent TCAR from 2018-2022. 154 (73%) were on dual antiplatelet therapy (DAPT) for at least 7 days prior to TCAR. Twenty-nine patients were not on DAPT due to therapeutic anticoagulation and most (38/56, 68%) received a loading dose of a second antiplatelet the day of surgery. Twenty-five patients (11.9%) experienced stent thrombosis within 30 days. Patients not on DAPT for at least 7 days prior to surgery were more prone to stent thrombosis (16.7% vs 10.4%, p=.164). Over half (133/210, 63%) of patients underwent resistance testing, 25 with thromboelastogram with platelet mapping (TEG-PM), 103 with VerifyNow P2Y12 platelet reactivity assay, and 5 with both. Prevalence of Clopidogrel resistance among tested patients was 41%. In patients tested using both TEG-PM and VerifyNow, agreement was poor (Cohen's Kappa -0.05). Among patients with resistance, 12 (22%) experienced stent thrombosis. Comparatively, 8 (10%) patients without resistance developed thrombosis (p=.021). VerifyNow P2Y12 platelet reactivity assay correctly predicted Clopidogrel-resistance more accurately than TEG-PM (70% versus 40%, p=.025) and had sensitivity of 56% and specificity of 73% for stent thrombosis. CONCLUSION: Our multi-institutional cohort confirms a high rate of Clopidogrel resistance in patients undergoing TCAR, with higher acute stent thrombosis rates noted in patients with resistance. VerifyNow P2Y12 platelet reactivity assays more reliably predict Clopidogrel resistance than TEG-PM.

Avoiding Complications with Transcarotid Artery Revascularization.

Transcarotid artery revascularization (TCAR) for carotid artery stenting offers an innovative method for treating carotid artery occlusive disease. This technique utilizes the ENROUTE Transcarotid Neuroprotection System (Silk Road Medical, Sunnyvale, CA) to temporarily reverse flow in the carotid artery prior to crossing or treating the carotid lesion, reducing the perioperative risk of stroke. Herein we summarize the available literature regarding potential complications that may be encountered when performing TCAR. We also report our group's real-world outcomes of 273 patients undergoing TCAR with median (interquartile range) follow up of 17.4 (4.4 - 38.7) months, including safety and restenosis data.

Transcarotid Artery Revascularization Learning Curves Differ between Surgeon Experience Level.

BACKGROUND: There has been ensuing interest in adopting transcarotid artery revascularization (TCAR), because of its low perioperative stroke and complication rates. In our study, we aimed to identify the case number at which there is improvement in TCAR technical proficiency. We also assessed how surgeon experience influenced outcomes. METHODS: The primary outcome was technical proficiency, measured by skin-to-skin, fluoroscopy, and flow reversal times. Secondary outcomes included hospital length of stay and perioperative complication rate. Data was collected from a deidentified database, which included all patients that had a TCAR between 2017 and 2023 at one of four hospitals. Cases were grouped by the experience of the surgeon who performed the case (<10 and >10 years). Linear mixed models were used to analyze primary outcomes after being log-transformed, due to their skewed distributions. The estimated level of the outcome was compared at the 1st, 5th, 10th and 15th surgery between surgeon groups, and the significance level was adjusted using the Bonferroni correction. RESULTS: There were 160 cases performed by 13 surgeons included in the study. Patients with hostile necks (23.9% vs. 9.7%, P=0.015) and contralateral occlusions (7.5% vs. 0%, P=0.007) were operated on more frequently by surgeons with <10 years of experience. There was no difference in secondary outcomes between groups. While primary outcomes between groups were not significant when comparing median values, linear mixed models demonstrated a significant improvement among the group of surgeons with less experience after the 15th case relative to their senior partners. At this point, they were operating with 30% less skin-to-skin time (P=0.002, 95% CI 13% to 44%) and 51% less fluoroscopy time (P=0.005, 95% CI 20% to 70%) compared to surgeons with >10 years of experience. There was no significant difference between groups with respect to flow reversal times. CONCLUSIONS: There was significant improvement experienced by the junior attendings relative to their senior partners after the fifteenth case. This was not influenced by patient characteristics nor the type of anesthesia used.

Evaluating postoperative outcomes in patients with hostile neck anatomy undergoing transcarotid artery revascularization versus transfemoral carotid artery stenting.

BACKGROUND: Carotid endarterectomy is relatively contraindicated in patients with a hostile neck anatomy who were historically revascularized with transfemoral carotid artery stenting (TFCAS). As transcarotid artery revascularization (TCAR) has progressively replaced TFCAS, evidence pertaining to hostile neck anatomy and TCAR is necessary to establish its safety and feasibility in this subgroup of patients. Therefore, we analyzed the impact of a hostile neck anatomy on outcomes in patients undergoing TCAR and further compared them with those undergoing TFCAS to establish recommendations for standard of care. METHODS: All patients undergoing TCAR and TFCAS from November 2016 to June 2021 in the Vascular Quality Initiative database were included. Patients were characterized into two groups based on the neck anatomy. Hostile neck anatomy was defined as a history of neck radiation or prior neck surgery including prior carotid endarterectomy or radical neck dissection. Primary outcomes included technical failure, access site complications (hematoma, stenosis, infection, pseudoaneurysm and arteriovenous fistula), and stroke or death. Secondary outcomes included stroke, transient ischemic attack (TIA), myocardial infarction (MI), death, and a composite end point of stroke or TIA. Patients with nonatherosclerotic or multiple lesions were excluded from the analysis. Primary analysis was performed with all patients undergoing TCAR and outcomes between patients with hostile and nonhostile neck anatomy were compared. Further analysis included a comparison of patients with a hostile neck anatomy undergoing TCAR and TFCAS. Univariable and multivariable logistic regression was used to assess impact of hostile neck anatomy on postoperative outcomes. Results were adjusted for relevant potential confounders including age, gender, race, degree of stenosis, symptomatic status, comorbidities, preoperative medications, anesthesia type, and protamine use. RESULTS: Among the 19,859 patients who underwent TCAR during the study period, 3636 (18.3%) had a hostile neck anatomy. On univariate analysis, both groups had comparable outcomes except for higher rates of stroke or death in patients with hostile neck anatomy. After adjusting for potential confounders, there were no differences in technical failure (adjusted odds ratio [aOR], 1.14; 95% confidence interval [CI], 0.59-2.21; P = .699), stroke (aOR, 0.86; 95% CI, 0.58-1.28; P = .464), death (aOR, 0.82; 95% CI, 0.39-1.71; P = .598), and MI (aOR, 1.18; 95% CI, 0.71-1.97; P = .518). However, patients with hostile neck were at a 30% increased risk of access site complications (aOR, 1.30; 95% CI, 1.0-1.6; P = .023). Further adjusted analysis comparing the outcomes in TFCAS and TCAR among patients with hostile neck anatomy showed an almost four-fold increase in risk of death (aOR, 3.77; 95% CI, 1.49-9.53; P = .005) and technical failure (aOR, 3.69; 95% CI, 1.82-7.47; P < .001) among patients undergoing treatment with TFCAS. CONCLUSIONS: Patients with a hostile neck anatomy undergoing TCAR experienced an increased risk of access site complications; however, the risk for technical failure and postoperative stroke/death, stroke, TIA, MI, or death was similar among both groups. TFCAS was associated with significant increase in the risk of death and technical failure compared with TCAR in this group of patients. These results confirm that TCAR should be the preferred minimally invasive revascularization procedure for patients with hostile neck anatomy.

Physiologic risk factors increase risk of myocardial infarction with transcarotid artery revascularization in prospective trials.

OBJECTIVE: Patients can be considered at high risk for carotid endarterectomy (CEA) because of either anatomic or physiologic factors and will often undergo transcarotid artery revascularization (TCAR). Patients with physiologic criteria will be considered to have a higher overall surgical risk because of more significant comorbidities. Our aim was to study the incidence of stroke, myocardial infarction (MI), death, and combined end points for patients who had undergone TCAR stratified by the risk factors (anatomic vs physiologic). METHODS: An analysis of prospectively collected data from the ROADSTER (pivotal; safety and efficacy study for reverse flow used during carotid artery stenting procedure), ROADSTER 2 (Food and Drug Administration indicated postmarket trial; postapproval study of transcarotid artery revascularization in patients with significant carotid artery disease), and ROADSTER extended access TCAR trials was performed. All 851 patients were considered to be at high risk for CEA and were included and stratified using high-risk anatomic criteria (ie, contralateral occlusion, tandem stenosis, high cervical artery stenosis, restenosis after previous endarterectomy, bilateral carotid stenting, hostile neck anatomy with previous neck irradiation, neck dissection, cervical spine immobility) or high-risk physiologic criteria (ie, age >75 years, multivessel coronary artery disease, history of angina, congestive heart failure New York Heart Association class III/IV, left ventricular ejection fraction <30%, recent MI, severe chronic obstructive pulmonary disease, permanent contralateral cranial nerve injury, chronic renal insufficiency). For trial inclusion, asymptomatic patients were required to have had ≥80% carotid stenosis and symptomatic patients to have had ≥50% stenosis. The primary outcome measures were stroke, death, and MI at 30 days. The data were statistically analyzed using the χ2 test, as appropriate. RESULTS: A total of 851 high surgical risk patients were categorized into two groups: those with anatomic-only risk factors (n = 372) or at least one physiologic risk factor present (n = 479). Of the 851 patients, 74.5% of those in the anatomic subset were asymptomatic, and 76.6% in the physiologic subset were asymptomatic. General anesthesia was used similarly in both groups (67.7% anatomic vs 68.1% physiologic). MI had occurred in eight patients in the physiologic group (1.7%), all of whom had been asymptomatic and in none of the anatomic patients (P = .01). The combined stroke, death, and MI rate was 2.1% in the anatomic cohort and 4.2% in the physiologic cohort (P = .10). Stratification of each group into asymptomatic and symptomatic patients did not yield any further differences. CONCLUSIONS: The patients who had undergone TCAR in the present prospective, neurologically adjudicated trial because of high-risk physiologic factors had had a higher rate of MI compared with the patients who had qualified for TCAR using anatomic criteria only. These patients had experienced comparable rates of combined stroke, death, and MI rates. The anatomic patients represented a healthier and younger subset of patients, with notably low overall event rates.

Transcarotid artery revascularization can safely be performed with regional anesthesia and no intensive care unit stay.

OBJECTIVE: Hospital resource use is under constant review, and the extent and intensity of postoperative care requirements for vascular surgical procedures is particularly relevant in the setting of the coronavirus disease 2019 pandemic and its impact on staffed intensive care unit (ICU) beds. We sought to evaluate the feasibility of regional anesthesia (RA) and low-intensity postoperative care for patients undergoing transcarotid artery revascularization (TCAR) at our institution. METHODS: All patients undergoing TCAR at a single institution from 2018 to 2020 were reviewed. Perioperative management (anticoagulation and antiplatelet therapy, hemodynamic monitoring, neurovascular examination, nursing instructions) was standardized by use of an institutional protocol. Anesthetic modality was at the surgeon's preference. Patients were transferred to a postanesthesia care unit for 2 hours followed by the step-down unit, to a postanesthesia care unit for 4 hours followed by the floor, or alternatively transferred to the ICU. Intravenous (IV) blood pressure medications could be administered at all environments except the floor. Recovery location and length of stay were recorded. RESULTS: A total of 83 patients underwent TCAR during the study period. The mean age 72 ± 9 years and 59% were male. Thirty-six percent were symptomatic. RA was used for 84% with none converted to general anesthesia (GA) intraoperatively. Postoperatively, 7 of the 83 patients (8%) included in this study were monitored in an ICU overnight (decided perioperatively), mostly for patients with prior neurological symptoms, but in 1 case for postoperative neurological event and in another owing to pulseless electrical activity arrest. Six patients required IV antihypertensives and eight required IV vasoactive support postoperatively. The mean length of ICU stay was 3.7 ± 5.1 days. The mean length of hospital stay for all patients was 2.4 ± 3.3 days. The length of stay for patients undergoing TCAR with GA was higher than those undergoing TCAR with RA (4.2 ± 4.9 days vs 1.4 ± 1.2 days, respectively; P = .066). The incidence of stroke, death, and myocardial infarction was 2.4%. There was one postoperative stroke considered to be a recrudescence of prior stroke, and one respiratory arrest fatality in a frail patient with neck hematoma both of whom were treated under GA. CONCLUSIONS: Using perioperative care protocols, TCAR can safely be performed while avoiding both GA and an ICU stay in most patients.

Efficacy and safety of single versus dual antiplatelet therapy in carotid artery stenting.

OBJECTIVE: Current guidelines recommend dual antiplatelet (AP) therapy (DAPT) before carotid artery stenting (CAS); however, the true clinical effect of single AP therapy vs DAPT is unknown. We examined the efficacy and safety of preoperative single AP therapy vs DAPT in patients who had undergone transfemoral CAS (tfCAS) or transcarotid artery revascularization (TCAR). METHODS: We identified all patients who had undergone tfCAS or TCAR in the Vascular Quality Initiative database from 2016 to 2021. We stratified the patients by procedure and identified those who had received the following preoperative AP regimens: DAPT (acetylsalicylic acid [ASA] + P2Y12 inhibitor [P2Yi]), no AP therapy, ASA only, ASA + AP loading dose, P2Yi only, and P2Yi + AP loading dose. The AP loading dose was given within 4 hours of CAS. We generated propensity scores for each treatment regimen and assessed in-hospital outcomes using inverse probability weighted log binomial regression, with DAPT as the reference and adjusting for intraoperative protamine use. The primary efficacy outcome was a composite end point of stroke and death, and the primary safety outcome was access-related bleeding. RESULTS: Of the 18,570 tfCAS patients, 70% had received DAPT, 5.6% no AP therapy, 10% ASA only, 8.0% ASA + AP loading dose, 4.6% P2Yi only, and 2.9% P2Yi + AP loading dose. The corresponding unadjusted rates of stroke/death were 2.2%, 6.8%, 4.1%, 5.1%, 2.4%, and 2.3%. After adjustment, compared with DAPT, the incidence of stroke/death was higher with no AP therapy (relative risk [RR], 2.3; 95% confidence interval [CI], 1.7-3.2), ASA only (RR, 1.6; 95% CI, 1.2-2.1), and ASA + AP loading dose (RR, 2.0; 95% CI, 1.5-2.7) but was similar with P2Yi only (RR, 0.99; 95% CI, 0.58-1.7) and P2Yi + AP loading dose (RR, 1.1; 95% CI, 0.49-2.5). Of the 25,459 TCAR patients, 81% had received DAPT, 2.0% no AP therapy, 5.5% ASA only, 3.5% ASA + AP loading dose, 4.9% P2Yi only, and 2.4% P2Yi + AP loading dose. The corresponding unadjusted rates of stroke/death were 1.5%, 3.3%, 3.3%, 2.9%, 1.2%, and 1.1%. After adjustment, compared with DAPT, the incidence of stroke/death was higher with no AP therapy (RR, 2.0; 95% CI, 1.2-3.3) and ASA only (RR, 2.2; 95% CI, 1.5-3.1), with a trend toward a higher incidence with ASA + AP loading dose (RR, 1.6; 95% CI, 0.99-2.6), and was similar with P2Yi only (RR, 0.98; 95% CI, 0.54-1.8) and P2Yi + AP loading dose (RR, 0.66; 95% CI, 0.27-1.6). No differences were found in the incidence of access-related bleeding between the treatment groups after tfCAS or TCAR. CONCLUSIONS: Compared with DAPT, no AP therapy or ASA monotherapy was associated with higher rates of stroke/death after CAS and should be discouraged as unsafe practice. Meanwhile, P2Yi monotherapy was associated with similar rates of stroke/death. No differences were found in the incidence of bleeding complications, and adding an AP loading dose to ASA or P2Yi monotherapy within 4 hours of the procedure did not affect the outcomes. Overall, these findings support the current guidelines recommending DAPT before CAS but also suggest that P2Yi monotherapy might confer thromboembolic benefits similar to those with DAPT. However, an immediate preoperative AP loading dose might not provide additional thromboembolic benefits.

Impact of calcified plaque volume on technical and 3-year outcomes after transcarotid artery revascularization.

OBJECTIVE: We sought to quantify the percent calcification within carotid artery plaques and assess its impact on percent residual stenosis and rate of restenosis in patients undergoing transcarotid artery revascularization for symptomatic and asymptomatic carotid artery stenosis. METHODS: A retrospective review of prospectively collected institutional Vascular Quality Initiative data was performed to identify all patients undergoing transcarotid artery revascularization from December 2015 to June 2021 (n = 210). Patient and lesion characteristics were extracted. Using a semiautomated workflow, preoperative computed tomography head and neck angiograms were analyzed to determine the calcified plaque volume in distal common carotid artery and internal carotid artery plaques. Intraoperative digital subtraction angiograms were reviewed to calculate the percent residual stenosis post-intervention according to North American Symptomatic Carotid Endarterectomy Trial criteria. Peak systolic velocity and end-diastolic velocity were extracted from outpatient carotid duplex ultrasound examinations. Univariate logistic regression was performed to analyze the relationship of calcium volume percent and Vascular Quality Initiative lesion calcification to percent residual stenosis in completion angiograms. Kaplan-Meier analysis examined the relationship between calcium volume percent and in-stent stenosis over 36 months. RESULTS: One hundred ninety-seven carotid arteries were preliminarily examined. Predilation was performed in 87.4% of cases with a mean balloon diameter of 5.1 ± 0.7 mm and a mean stent diameter was 8.8 ± 1.1 mm. The mean calcium volume percent was 11.9 ± 12.4% and the mean percent residual stenosis was 16.1 ± 15.6%. Univariate logistic regression demonstrated a statistically significant difference between calcium volume percent and percent residual stenosis (odds ratio [OR], 1.324; 95% confidence interval [CI], 1.005-1.746; P = .046). Stratified by quartile, only the top 25% of calcified plaques (>18.7% calcification) demonstrated a statistically significant association with higher percent residual stenosis (OR, 2.532; 95% CI, 1.049-6.115; P =.039). There was no statistical significance with lesion calcification (OR, 1.298; 95% C,: 0.980-1.718; P = .069). A Kaplan-Meier analysis demonstrated a statistically significant increase in the rate of in-stent stenosis during a 36-month follow-up for lesions containing >8.2% calcium volume (P = .0069). CONCLUSIONS: A calcium volume percent of >18.7% was associated with a higher percent residual stenosis, and a calcium volume percent of >8.2% was associated with higher in-stent stenosis at 36 months. There was one clinically diagnosed stroke during the follow-up period, demonstrating the overall safety of the procedure.

Vascular Quality Initiative assessment of compliance with Society for Vascular Surgery clinical practice guidelines on the management of extracranial cerebrovascular disease.

OBJECTIVES: Compliance with Society for Vascular Surgery (SVS) clinical practice guidelines (CPGs) is associated with improved outcomes for the treatment of abdominal aortic aneurysm, but this has not been assessed for carotid artery disease. The Vascular Quality Initiative (VQI) registry was used to examine compliance with the SVS CPGs for the management of extracranial cerebrovascular disease and its impact on outcomes. METHODS: The 2021 SVS extracranial cerebrovascular disease CPGs were reviewed for evaluation by VQI data. Compliance rates by the center and provider were calculated, and the impact of compliance on outcomes was assessed using logistic regression with inverse probability-weighted risk adjustment for each CPG recommendation, allowing for clustering by the center. Our primary outcome was a composite end point of in-hospital stroke/death. As a secondary analysis, compliance with the 2021 SVS carotid implementation document recommendations and associated outcomes were also assessed. RESULTS: Of the 11 carotid CPG recommendations, 4 (36%) could be evaluated using VQI registry data. Median center-specific CPG compliance ranged from 38% to 95%, and median provider-specific compliance ranged from 36% to 100%. After adjustment, compliance with 2 of the recommendations was associated with lower rates of in-hospital stroke/death: first, the use of best medical therapy (antiplatelet and statin therapy) in low/standard surgical risk patients undergoing carotid endarterectomy for >70% asymptomatic stenosis (event rate in compliant vs noncompliant cases 0.59% vs 1.3%; adjusted odds ratio: 0.44, 95% confidence interval: 0.29-0.66); and second, carotid endarterectomy over transfemoral carotid artery stenting in low/standard surgical risk patients with >50% symptomatic stenosis (1.9% vs 3.4%; adjusted odds ratio: 0.55, 95% confidence interval: 0.43-0.71). Of the 132 implementation document recommendations, only 10 (7.6%) could be assessed using VQI data, with median center- and provider-specific compliance rates ranging from 67% to 100%. The impact of compliance on outcomes could only be assessed for 6 (4.5%) of these recommendations, and compliance with all 6 recommendations was associated with lower stroke/death. CONCLUSIONS: Few SVS recommendations could be assessed in the VQI because of incongruity between the recommendations and the VQI data variables collected. Although guideline compliance was extremely variable among VQI centers and providers, compliance with most of these recommendations was associated with improved outcomes after carotid revascularization. This finding confirms the value of guideline compliance, which should be encouraged for centers and providers. Optimization of VQI data to promote evaluation of guideline compliance and distribution of these findings to VQI centers and providers will help facilitate quality improvement efforts in the care of vascular patients.

Society for Vascular Surgery duplex ultrasound surveillance guidelines are safe and cost effective for transcarotid artery revascularization.

BACKGROUND: Carotid duplex ultrasound (CDUS) examination is used in the long-term surveillance after transcarotid artery revascularization (TCAR). The objective of this study was to evaluate the usefulness and cost effectiveness of post-TCAR CDUS surveillance regimens in monitoring for in-stent restenosis (ISR) and associated stroke risk at a single-center community institution. METHODS: CDUS data were collected retrospectively from patients who had undergone TCAR between January 2017 and January 2023. ISR >50% was defined as a peak systolic velocity (PSV) of >220 cm/s and an internal carotid artery (ICA) to common carotid velocity ratio of >2.7. ISR >80% was defined as a PSV of >340 cm/s and an ICA/common carotid artery ratio of >4.15. Study outcomes included incidences of ISR, reintervention, transient ischemic attacks (TIAs), strokes, and mortality. A Kaplan-Meier survival analysis was done to calculate the rates of freedom from ISR. RESULTS: During the study period, 108 TCAR stents were deployed in 104 patients. Eight patients were excluded in analysis or lost to follow-up. Preoperatively, 62% of patients had >80% stenosis, and 39% were symptomatic. No intraprocedural complications were noted. One patient suffered an immediate postoperative dissection. Eight stents (8%) experienced ISR progression from <50% to >50%. Three of the eight had further ISR progression to >80%. One patient had high-grade ISR and a contralateral ICA occlusion that warranted reintervention. There were no occurrences of postoperative TIAs, strokes, or TCAR-related deaths. Rates of freedom from ISR progression from <50% to >50% were 97.4%, 95.9%, 90.9%, 88.2%, and 88.2% at 6, 12, 24, 36, and 42 months, respectively. Rates of freedom from ISR >80% were 100%, 100%, 98.5%, 95.5%, and 95.5% at the same time points. Patients with >50% ISR tended to be females with hyperlipidemia. In addition, they had higher average lesion lengths and lower rates of postdilation balloon angioplasty. The 5-year estimated surveillance cost in this cohort using the Society for Vascular Surgery 2022, and 2018 guidelines, as well as our current protocol would be $113,853, $221,382, and $193,207, respectively. CONCLUSIONS: This study revealed a low incidence of ISR progression, as well as no TIA, stroke, or TCAR-related deaths, highlighting the safety and efficacy of TCAR. Post-TCAR CDUS examination using the updated Society for Vascular Surgery guidelines are safe and cost effective. Patients with contralateral occlusion or stenosis, or who have significant risk factors, should have more frequent surveillance regimens.

Regional variation in patient selection, practice patterns, and outcomes based on techniques for carotid artery revascularization in the Vascular Quality Initiative.

OBJECTIVE: Significant regional variation is known with multiple surgical procedures. This study describes regional variation in carotid revascularization within the Vascular Quality Initiative (VQI). METHODS: Data from the VQI carotid endarterectomy (CEA) and carotid artery stenting (CAS) databases from 2016 to 2021 were used. Nineteen geographic VQI regions were divided into three tertiles based on the average annual volume of carotid procedures performed per region (low-volume: 956 cases [range, 144-1382]; medium-volume: 1533 cases [range, 1432-1589]; and high-volume: 1845 cases [range, 1642-2059]). Patients' characteristics, indications for carotid revascularization, practice patterns, and outcomes (perioperative and 1-year stroke/death) of different revascularization techniques were compared between these regional groups. Regression models that adjust for known risk factors and allow for random effects at the center level were used. RESULTS: CEA was the most common revascularization procedure (>60%) across all regional groups. Significant regional variation was observed in the practice of CEA such as variability in the use of shunting, drain placement, stump pressure and electroencephalogram monitoring, intraoperative protamine, and patch angioplasty. For transfemoral CAS, high-volume regions had a higher proportion of asymptomatic patients with <80% stenosis (30.5% vs 27.8%) in addition to higher use of local/regional anesthesia (80.4% vs 76.2%), protamine (16.1% vs 11.8%), and completion angiography (81.6% vs 77.6%) during transfemoral carotid artery stenting (TF-CAS) compared with low-volume regions. For transcarotid artery revascularization (TCAR), high-volume regions were less likely to intervene on asymptomatic patients with <80% stenosis (32.2% vs 35.8%) than low-volume regions. They also had a higher proportion of urgent/emergent procedures (13.6% vs 10.4%) and were more likely to use general anesthesia (92.0% vs 82.1%), completion angiography (67.3% vs 63.0%), and poststent ballooning (48.4% vs 36.8%). For each carotid revascularization technique, no significant differences were noted in perioperative and 1-year outcomes between low-, medium-, and high-volume regions. Finally, there were no significant differences in outcomes between TCAR and CEA across the different regional groups. In all regional groups, TCAR was associated with a 40% reduction in perioperative and 1-year stroke/death compared with TF-CAS. CONCLUSIONS: Despite significant variation in clinical practices for the management of carotid disease, no regional variation exists in the overall outcomes of carotid interventions. TCAR and CEA continue to show superior outcomes to TF-CAS across all VQI regional groups.

Assessment of Conflicts of Interest in the Transcarotid Artery Revascularization Literature.

INTRODUCTION: To systematically review the accuracy of self-reported conflicts of interest (COIs) among transcarotid artery revascularization (TCAR) studies and evaluate factors associated with increased discrepancies. MATERIALS AND METHODS: A literature search identified all TCAR-related studies with at least one American author published between January 2017 and December 2020. Industry payments from Silk Road Medical, Inc. were collected using the Centers for Medicare and Medicaid Open Payments database. COI discrepancies were identified by comparing author declaration statements with payments found for the year of publication and year prior (24-mo period). Risk factors for COI discrepancy were evaluated at both the study and author level. RESULTS: A total of 79 studies (472 authors) were identified. Sixty four studies (81%) had at least one author who received payments from Silk Road Medical, Inc. Fifty eight (73%) studies had at least one author who received an undeclared payment. Consulting fees represented the majority of general payment subtype (60%). Authors who accurately disclosed payments received significantly higher median payments compared to authors who did not accurately disclose payments ($37,222 [interquartile range: $28,203-$132,589] versus $1748 [interquartile range $257-$35,041], P < 0.0001). Senior authors were significantly more likely to have a COI discrepancy compared to first authors (P = 0.0219). CONCLUSIONS: The majority of TCAR-related studies did not accurately declare COI. A multivariate analysis demonstrated no effect of sponsorship on study recommendations or impact factor. This study highlights the need for increased efforts in accountability to improve the transparency of industry sponsorship, especially when consulting authors are reporting their results on patient outcomes.

In-hospital and one-year outcomes are similar for women and men following transcarotid artery revascularization in symptomatic and asymptomatic patients.

OBJECTIVE: In randomized controlled trials and retrospective series, women have higher rates of periprocedural stroke and death following carotid endarterectomy and transfemoral carotid artery stenting compared with men. We sought to compare outcomes by sex following transcarotid artery revascularization (TCAR) among patients in the Vascular Quality Initiative (VQI). METHODS: We reviewed all patients in the VQI who underwent TCAR from 2017 to 2020. We stratified the analysis by symptom status. The primary outcome was in-hospital stroke/death, and secondary outcomes were in-hospital stroke and death and 1-year stroke/death, stroke, and death. We used multivariable logistic and Cox regression models to assess the association of sex with in-hospital and 1-year outcomes after adjusting for preoperative and intraoperative characteristics. RESULTS: We identified 15,851 patients who underwent TCAR, of whom 7391 (47%) were symptomatic (2708 or 37% female) and 8460 (53%) were asymptomatic (3097 or 37% female). Women were less frequently considered anatomic high risk than men in both groups (symptomatic: 43% vs 46%; P = .004; asymptomatic: 44% vs 48%; P = .004). Among symptomatic patients, women more often had severe ≥70% stenosis (89% vs 87%; P = .02). There were no differences in in-hospital death, stroke, or stroke/death for women vs men following TCAR among symptomatic or asymptomatic patients (all P > .05). After adjusting for baseline differences between groups, female sex was not associated with in-hospital stroke/death in either symptomatic (odds ratio, 1.05; 95% confidence interval, 0.72-1.56) or asymptomatic (odds ratio, 0.93; 95% confidence interval, 0.53-1.63) patients undergoing TCAR. There were also no differences in 1-year stroke, death, or stroke/death risk for women compared with men with and without symptoms on unadjusted or adjusted analyses (P > .05). CONCLUSIONS: We found no sex differences in in-hospital or 1-year stroke/death following TCAR, regardless of symptom status. TCAR appears to be as safe of a surgical procedure for women as for men in patients with both symptomatic and asymptomatic carotid artery disease.