Using Machine Learning to Predict Outcomes Following Transfemoral Carotid Artery Stenting.

BACKGROUND: Transfemoral carotid artery stenting (TFCAS) carries important perioperative risks. Outcome prediction tools may help guide clinical decision-making but remain limited. We developed machine learning algorithms that predict 1-year stroke or death following TFCAS. METHODS AND RESULTS: The VQI (Vascular Quality Initiative) database was used to identify patients who underwent TFCAS for carotid artery stenosis between 2005 and 2024. We identified 112 features from the index hospitalization (82 preoperative [demographic/clinical], 13 intraoperative [procedural], and 17 postoperative [in-hospital course/complications]). The primary outcome was 1-year postprocedural stroke or death. The data were divided into training (70%) and test (30%) sets. Six machine learning models were trained using preoperative features with 10-fold cross-validation. The primary model evaluation metric was area under the receiver operating characteristic curve. The algorithm with the best performance was further trained using intra- and postoperative features. Model robustness was assessed using calibration plots and Brier scores. Overall, 35 214 patients underwent TFCAS during the study period and 3257 (9.2%) developed 1-year stroke or death. The best preoperative prediction model was extreme gradient boosting, achieving an area under the receiver operating characteristic curve of 0.94 (95% CI, 0.93-0.95). In comparison, logistic regression had an AUROC of 0.65 (95% CI, 0.63-0.67). The extreme gradient boosting model maintained excellent performance at the intra- and postoperative stages, with area under the receiver operating characteristic curve values of 0.94 (95% CI, 0.93-0.95) and 0.98 (95% CI, 0.97-0.99), respectively. Calibration plots showed good agreement between predicted/observed event probabilities with Brier scores of 0.11 (preoperative), 0.11 (intraoperative), and 0.09 (postoperative). CONCLUSIONS: Machine learning can accurately predict 1-year stroke or death following TFCAS, performing better than logistic regression.

Postoperative outcomes in patients with anemia undergoing carotid revascularization.

BACKGROUND: Preoperative anemia is associated with worse postoperative morbidity and mortality after major vascular procedures. Limited research has examined the optimal method of carotid revascularization in patients with anemia. Therefore, we aim to compare the postoperative outcomes after carotid endarterectomy (CEA), transfemoral carotid artery stenting (TFCAS), and transcarotid artery revascularization (TCAR) among patients with anemia. STUDY DESIGN: This is a retrospective review of patients with anemia undergoing CEA, TFCAS, and TCAR in the Vascular Quality Initiative database between 2016 and 2023. We defined anemia as a preoperative hemoglobin level of <13 g/dL in men and <12 g/dL in women. The primary outcomes were 30-day mortality and in-hospital major adverse cardiac events (MACE). Logistic regression models were used for multivariate analyses. RESULTS: Our study included 40,383 CEA (59.3%), 9159 TFCAS (13.5%), and 18,555 TCAR (27.3%) cases in patients with anemia. TCAR patients were older and had more medical comorbidities than CEA and TFCAS patients. TCAR was associated with a decreased 30-day mortality (adjusted odds ratio [aOR], 0.45; 95% confidence interval [CI], 0.37-0.59; P < .001), in-hospital MACE (aOR, 0.58; 95% CI, 0.46-0.75; P < .001) compared with TFCAS. Additionally, TCAR was associated with a 20% decrease in the risk of 30-day mortality (aOR, 0.80; 95% CI, 0.65-0.98; P = .03) and a similar risk of in-hospital MACE (aOR, 0.86; 95% CI, 0.77-1.01; P = .07) compared with CEA. Furthermore, TFCAS was associated with an increased risk of 30-day mortality (aOR, 2; 95% CI, 1.5-2.68; P < .001) and in-hospital MACE (aOR, 1.7; 95% CI, 1.4-2; P < .001) compared with CEA. CONCLUSIONS: In this multi-institutional national retrospective analysis of a prospectively collected database, TFCAS was associated with a high risk of 30-day mortality and in-hospital MACE compared with CEA and TCAR in patients with anemia. TCAR was associated with a lower risk of 30-day mortality compared with CEA. These findings suggest TCAR as the optimal minimally invasive procedure for carotid revascularization in patients with anemia.

Predictors of prolonged length of stay after elective carotid revascularization.

OBJECTIVE: Postoperative day-one discharge is used as a quality-of-care indicator after carotid revascularization. This study identifies predictors of prolonged length of stay (pLOS), defined as a postprocedural LOS of >1 day, after elective carotid revascularization. METHODS: Patients undergoing carotid endarterectomy (CEA), transcarotid artery revascularization (TCAR), and transfemoral carotid artery stenting (TFCAS) in the Vascular Quality Initiative between 2016 and 2022 were included in this analysis. Multivariable logistic regression analysis was used to identify predictors of pLOS, defined as a postprocedural LOS of >1 day, after each procedure. RESULTS: A total of 118,625 elective cases were included. pLOS was observed in nearly 23.2% of patients undergoing carotid revascularization. Major adverse events, including neurological, cardiac, infectious, and bleeding complications, occurred in 5.2% of patients and were the most significant contributor to pLOS after the three procedures. Age, female sex, non-White race, insurance status, high comorbidity index, prior ipsilateral CEA, non-ambulatory status, symptomatic presentation, surgeries occurring on Friday, and postoperative hypo- or hypertension were significantly associated with pLOS across all three procedures. For CEA, additional predictors included contralateral carotid artery occlusion, preoperative use of dual antiplatelets and anticoagulation, low physician volume (<11 cases/year), and drain use. For TCAR, preoperative anticoagulation use, low physician case volume (<6 cases/year), no protamine use, and post-stent dilatation intraoperatively were associated with pLOS. One-year analysis showed a significant association between pLOS and increased mortality for all three procedures; CEA (hazard ratio [HR],1.64; 95% confidence interval [CI], 1.49-1.82), TCAR (HR,1.56; 95% CI, 1.35-1.80), and TFCAS (HR, 1.33; 95%CI, 1.08-1.64) (all P < .05). CONCLUSIONS: A postoperative LOS of more than 1 day is not uncommon after carotid revascularization. Procedure-related complications are the most common drivers of pLOS. Identifying patients who are risk for pLOS highlights quality improvement strategies that can optimize short and 1-year outcomes of patients undergoing carotid revascularization.

Seven years of the transcarotid artery revascularization surveillance project, comparison to transfemoral stenting and endarterectomy.

OBJECTIVE: This study utilizes the latest data from the Vascular Quality Initiative (VQI), which now encompasses over 50,000 transcarotid artery revascularization (TCAR) procedures, to offer a sizeable dataset for comparing the effectiveness and safety of TCAR, transfemoral carotid artery stenting (tfCAS), and carotid endarterectomy (CEA). Given this substantial dataset, we are now able to compare outcomes overall and stratified by symptom status across revascularization techniques. METHODS: Utilizing VQI data from September 2016 to August 2023, we conducted a risk-adjusted analysis by applying inverse probability of treatment weighting to compare in-hospital outcomes between TCAR vs tfCAS, CEA vs tfCAS, and TCAR vs CEA. Our primary outcome measure was in-hospital stroke/death. Secondary outcomes included myocardial infarction and cranial nerve injury. RESULTS: A total of 50,068 patients underwent TCAR, 25,361 patients underwent tfCAS, and 122,737 patients underwent CEA. TCAR patients were older, more likely to have coronary artery disease, chronic kidney disease, and undergo coronary artery bypass grafting/percutaneous coronary intervention as well as prior contralateral CEA/CAS compared with both CEA and tfCAS. TfCAS had higher odds of stroke/death when compared with TCAR (2.9% vs 1.6%; adjusted odds ratio [aOR], 1.84; 95% confidence interval [CI], 1.65-2.06; P < .001) and CEA (2.9% vs 1.3%; aOR, 2.21; 95% CI, 2.01-2.43; P < .001). CEA had slightly lower odds of stroke/death compared with TCAR (1.3% vs 1.6%; aOR, 0.83; 95% CI, 0.76-0.91; P < .001). TfCAS had lower odds of cranial nerve injury compared with TCAR (0.0% vs 0.3%; aOR, 0.00; 95% CI, 0.00-0.00; P < .001) and CEA (0.0% vs 2.3%; aOR, 0.00; 95% CI, 0.0-0.0; P < .001) as well as lower odds of myocardial infarction compared with CEA (0.4% vs 0.6%; aOR, 0.67; 95% CI, 0.54-0.84; P < .001). CEA compared with TCAR had higher odds of myocardial infarction (0.6% vs 0.5%; aOR, 1.31; 95% CI, 1.13-1.54; P < .001) and cranial nerve injury (2.3% vs 0.3%; aOR, 9.42; 95% CI, 7.78-11.4; P < .001). CONCLUSIONS: Although tfCAS may be beneficial for select patients, the lower stroke/death rates associated with CEA and TCAR are preferred. When deciding between CEA and TCAR, it is important to weigh additional procedural factors and outcomes such as myocardial infarction and cranial nerve injury, particularly when stroke/death rates are similar. Additionally, evaluating subgroups that may benefit from one procedure over another is essential for informed decision-making and enhanced patient care in the treatment of carotid stenosis.

Young patients undergoing carotid stenting procedures have an increased rate of procedural failure at 1-year follow-up.

OBJECTIVE: The outcomes of patients with premature cerebrovascular disease (age ≤55 years) who undergo carotid artery stenting are not well-defined. Our study objective was to analyze the outcomes of younger patients undergoing carotid stenting. METHODS: The Society for Vascular Surgery Vascular Quality Initiative was queried for transfemoral carotid artery stenting (TF-CAS) and transcarotid artery revascularization (TCAR) procedures between 2016 and 2020. Patients were stratified based on age ≤55 or >55 years. Primary endpoints were periprocedural stroke, death, myocardial infarction (MI), and composite outcomes. Secondary endpoints included procedural failure (defined as ipsilateral restenosis ≥80% or occlusion) and reintervention rates. RESULTS: Of the 35,802 patients who underwent either TF-CAS or TCAR, 2912 (6.1%) were ≤55 years. Younger patients were less likely than older patients to have coronary disease (30.5% vs 50.2%; P < .001), diabetes (31.5% vs 37.9%; P < .001), and hypertension (71.8% vs 89.8%; P < .001), but were more likely to be female (45% vs 35.4%; P < .001) and active smokers (50.9% vs 24.0%; P < .001) Younger patients were also more likely to have had a prior transient ischemic attack or stroke than older patients (70.7% vs 56.9%; P < .001). TF-CAS was more frequently performed in younger patients (79.7% vs 55.4%; P < .001). In the periprocedural period, younger patients were less likely to have a MI than older patients (0.3% vs 0.7%; P < .001), but there was no significant difference in the rates of periprocedural stroke (1.5% vs 2.0%; P = .173) and composite outcomes of stroke/death (2.6% vs 2.7%; P = .686) and stroke/death/MI (2.9% vs 3.2%; P = .353) between our two cohorts. The mean follow-up was 12 months regardless of age. During follow-up, younger patients were significantly more likely to experience significant (≥80%) restenosis or occlusion (4.7% vs 2.3%; P = .001) and to undergo reintervention (3.3% vs 1.7%; P < .001). However, there was no statistical difference in the frequency of late strokes between younger and older patients (3.8% vs 3.2%; P = .129). CONCLUSIONS: Patients with premature cerebrovascular disease undergoing carotid artery stenting are more likely to be African American, female, and active smokers than their older counterparts. Young patients are also more likely to present symptomatically. Although periprocedural outcomes are similar, younger patients have higher rates of procedural failure (significant restenosis or occlusion) and reintervention at 1-year follow-up. However, the clinical implication of late procedural failure is unknown, given that we found no significant difference in the rate of stroke at follow-up. Until further longitudinal studies are completed, clinicians should carefully consider the indications for carotid stenting in patients with premature cerebrovascular disease, and those who do undergo stenting may require close follow-up.

Periprocedural P2Y12 inhibitors improve perioperative outcomes after carotid stenting by primarily decreasing strokes.

OBJECTIVE: The continuation of antiplatelet agents in the periprocedural period around carotid stenting (CAS) procedures is felt to be mandatory to minimize the risk of periprocedural stroke. However, the optimal antiplatelet regimen is unclear, with some advocating dual antiplatelet therapy, and others supporting the use of P2Y12 inhibitors alone. The objective of this study was to evaluate the periprocedural effect of P2Y12 inhibitors for CAS. METHODS: The Vascular Quality Initiative was used from years 2007 to 2020. All transcarotid artery revascularization (TCAR) and transfemoral carotid artery stenting (TF-CAS) procedures were included. Patients were stratified based on perioperative use of P2Y12 inhibitors as well as symptomatic status. Primary end points were perioperative neurological events (strokes and transient ischemic attacks). Secondary end points were mortality and myocardial infarction. RESULTS: A total of 31,036 CAS procedures were included for analysis, with 49.8% TCAR and 50.2% TF-CAS cases; 63.8% of patients were male and 82.3% of patients were on a P2Y12 inhibitor. P2Y12 inhibitor use was more common in males, asymptomatic patients, those older than 70 years, and concurrent statin use. P2Y12 inhibitors were more likely to be used in TCAR cases than in TF-CAS cases (87.3% vs 76.8%; P < .001). The rate of periprocedural neurological events in the whole cohort was 2.6%. Patients on P2Y12 inhibitors were significantly less likely to experience a periprocedural neurological event (2.3% vs 3.9%; P < .001) and mortality (0.6% vs 2.1%; P < .001) than those who were not on a P2Y12 inhibitor. There was no effect on the rates of myocardial infarction. On multivariate analysis, both symptomatic and asymptomatic patients on P2Y12 inhibitors were significantly less likely to develop perioperative neurological events. Additionally, the use of P2Y12 inhibitors demonstrated an independent significant effect in reducing of the rate of perioperative stroke (odds ratio, 0.29; 95% confidence interval, 0.25-0.33). Finally, additional analysis of the types of P2Y12 inhibitors used revealed that all seemed to be equally effective in decreasing the periprocedural neurological event rate. CONCLUSIONS: The use of perioperative P2Y12 inhibitors seems to markedly decrease the perioperative neurological event rate with TCAR and TF-CAS in both symptomatic and asymptomatic patients and should be strongly considered. Patients with contraindications to P2Y12 inhibitors may not be appropriate candidates for any CAS procedure. Additionally, alternative types of P2Y12 inhibitors seem to be equally effective as clopidogrel. Finally, an analysis of the Vascular Quality Initiative demonstrates that, even for TCAR cases, only 87.3% of patients seem to be on P2Y12 inhibitors in the periprocedural period, leaving room for significant improvement.

Carotid stenosis patients with a remote history of cerebrovascular events have increased risk of major adverse events over asymptomatic patients.

INTRODUCTION: Asymptomatic patients with a remote history of transient ischemic attack (TIA) or stroke are not well studied as a separate population from asymptomatic patients with no prior history of TIA or stroke. We compared in-hospital outcomes after transcarotid artery revascularization (TCAR) and transfemoral carotid artery stenting (TFCAS) among symptomatic patients, patients with a remote history of neurologic symptoms, and asymptomatic patients. METHODS: Data from patients in the Vascular Quality Initiative database who underwent TCAR (January 2017 to April 2020) or TFCAS (May 2005 to April 2020) were analyzed. Symptomatic status was defined as TIA and/or stroke occurring within 180 days before the procedure. Asymptomatic status was divided into patients with no history of TIA/stroke (asymptomatic) and patients with a history of TIA/stroke occurring more than 180 days before the procedure (remote history of neurologic symptoms). The Student t-test and Pearson χ2 test were used to compare baseline patient characteristics and outcomes. Multivariate logistic regression was used to adjust for significant between-group differences in baseline characteristics. RESULTS: There were 7158 patients who underwent TCAR (symptomatic: 2574, asymptomatic: 3689, and asymptomatic with a remote history of neurologic symptoms: 895) and 18,023 patients who underwent TFCAS (symptomatic: 6195, asymptomatic: 10,333, and asymptomatic with a remote history of neurologic symptoms: 1495). Regardless of symptom status, the mean patient age was 73 years for TCAR and 69 years for TFCAS. A total of 64% of patients in the study were male and 36% of patients were female. The mean long-term follow-up data ranged between 208 and 331 days within the three patient groups. Carotid stenosis patients with a remote history of neurologic symptoms had higher rates of TIA, stroke, TIA/stroke, stroke/death, and stroke/death/myocardial infarction than asymptomatic patients, and these rates were similar to those of symptomatic patients. Comparing TCAR and TFCAS among patients with a remote history of neurologic symptoms, there were statistically significant reductions in the odds of stroke/death (odds ratio: 0.46, 95% confidence interval: 0.27-0.84, P = .011) and stroke/death/myocardial infarction (odds ratio: 0.51, 95% confidence interval: 0.30-0.87, P = .013) after TCAR. This was likely driven by the increased rate of death after TFCAS in patients with a remote history of neurologic symptoms (0.9%) compared with asymptomatic patients (0.6%). CONCLUSIONS: Asymptomatic patients with a remote history of TIA/stroke do not have the same outcomes as asymptomatic patients without a history of TIA/stroke and are at higher risk of adverse in-hospital events. Patients with a remote history of TIA/stroke have increased risk of in-hospital death after TFCAS and may benefit from TCAR.

Association of carotid revascularization approach with perioperative outcomes based on symptom status and degree of stenosis among octogenarians.

OBJECTIVE: Age ≥80 years is known to be an independent risk factor for periprocedural stroke after transfemoral carotid artery stenting (TF-CAS) but not after carotid endarterectomy (CEA). The objective of the present study was to compare the perioperative outcomes for CEA, TF-CAS, and transcarotid artery revascularization (TCAR) among octogenarian patients (aged ≥80 years) overall and stratified by symptom status and degree of stenosis. METHODS: All patients aged ≥80 years with 50% to 99% carotid artery stenosis who had undergone CEA, TF-CAS, or TCAR in the Vascular Quality Initiative (2005-2020) were included. We compared the perioperative (30-day) incidence of ipsilateral stroke or death for CEA vs TF-CAS vs TCAR using analysis of variance and multivariable logistic regression models. The results were confirmed in a sensitivity analysis stratified by symptom status and degree of stenosis. RESULTS: Overall, 28,571 carotid revascularization procedures were performed in patients aged ≥80 years: CEA, n = 20,912 (73.2%), TF-CAS, n = 3628 (12.7%), and TCAR, n = 4031 (14.1%). The median age was 83 years (interquartile range, 81.0-86.0 years); 49.8% of the patients were symptomatic (51.9% CEA, 46.2% TF-CAS, 42.4% TCAR); and 60.7% had high-grade stenosis (59.0% CEA, 65.2% TF-CAS, 65.4% TCAR). Perioperative stroke/death occurred most frequently following TF-CAS (6.6%), followed by TCAR (3.1%) and CEA (2.5%; P < .001). After adjusting for baseline differences between groups, the odds ratio (OR) for stroke/death was greater for TF-CAS vs CEA (adjusted OR [aOR], 3.35; 95% confidence interval [CI], 2.65-4.23), followed by TCAR vs CEA (aOR 1.49, 95% CI 1.18-1.87). The risk of perioperative stroke/death remained significantly greater for TF-CAS compared with CEA regardless of symptom status and degree of stenosis (P < .05 for all). In contrast, the risk of stroke/death was higher for TCAR vs CEA for asymptomatic patients (aOR, 2.04; 95% CI, 1.41-2.94) and those with high-grade stenosis (aOR, 1.49; 95% CI, 1.11-2.05) but similar for patients with symptomatic and moderate-grade disease (P > .05 for both). The risk of myocardial infarction was lower with TCAR (aOR, 0.59; 95% CI, 0.40-0.87) and TF-CAS (aOR, 0.56; 95% CI, 0.40-0.87) compared with CEA overall. CONCLUSIONS: Overall, TCAR and CEA can be safely offered to older adults, in particular, symptomatic patients and those with moderate-grade stenosis. TF-CAS should be avoided in older patients when possible.

Severity of stenosis in symptomatic patients undergoing carotid interventions might influence perioperative neurologic events.

OBJECTIVE: The carotid artery plaque burden, indirectly measured by the degree of stenosis, quantifies a patient's future embolic risk. In natural history studies, patients with moderate degrees of stenosis have had a lower stroke risk than those with severe stenosis. However, patients with symptomatic carotid stenosis who have experienced transient ischemic attack (TIA) or stroke were found to have both moderate and severe degrees of stenosis. We examined the association of carotid artery stenosis severity with the outcomes for symptomatic patients who had undergone carotid intervention, including carotid endarterectomy (CEA), transfemoral carotid artery stenting (TFCAS), and transcervical carotid artery revascularization (TCAR). METHODS: The Society for Vascular Surgery Vascular Quality Initiative database was queried for all patients who had undergone TFCAS, CEA, or TCAR between 2003 and 2020. The patients were stratified into two groups according to stenosis severity-nonsevere (0%-69%) and severe (≥70%). The primary end point was periprocedural neurologic events (stroke and TIA). The secondary end points were periprocedural death, myocardial infarction (MI), and the composite outcomes of stroke/death and stroke/death/MI in accordance with the reporting standards for carotid intervention. RESULTS: Of the 29,614 included symptomatic patients, 5296 (17.9%) had undergone TCAR, 7844 (26.5%) TFCAS, and 16,474 (55.6%) CEA for symptomatic carotid artery stenosis. In the CEA cohort, the neurologic event rate was significantly lower for the patients with severe stenosis than for those with nonsevere stenosis (2.6% vs 3.2%; P = .024). In the TCAR cohort, the periprocedural neurologic even rate was lower for those with severe stenosis than for those with nonsevere stenosis (3% vs 4.3%; P = .033). No similar difference was noted for the TFCAS cohort, with a periprocedural neurologic event rate of 3.8% in the severe group vs 3.5% in the nonsevere group (P = .518). On multivariable analysis, severe stenosis was associated with significantly decreased odds of postprocedural neurologic events after CEA (odds ratio, 0.75; 95% confidence interval, 0.6-0.92; P = .007) and TCAR (odds ratio, 0.83; 95% confidence interval, 0.69-0.99; P = .039) but not after TFCAS. CONCLUSIONS: Severe carotid stenosis, in contrast to more moderate stenosis degrees, was associated with decreased rates of periprocedural stroke and TIA in symptomatic patients undergoing TCAR and CEA but not TFCAS. The finding of increased rates of periprocedural neurologic events in symptomatic patients with lesser degrees of stenosis undergoing TCAR and CEA warrants further evaluation with a particular focus on plaque morphology and brain physiology and their inherent risks with carotid revascularization procedures.

Analysis of the anatomic eligibility for transcarotid artery revascularization in Chinese patients who underwent carotid endarterectomy and transfemoral carotid artery stenting.

Objective: Transcarotid artery revascularization (TCAR) is thought to be a promising technique and instrument for treating carotid stenosis with favorable outcomes. Since there remain several differences in anatomic characteristics among races, this study was conducted to investigate the anatomic eligibility of TCAR in Chinese patients who underwent carotid revascularization. Methods: A retrospective review of patients with carotid stenosis from 2019 to 2021 was conducted. The anatomic eligibility of TCAR was based on the instruction of the ENROUTE Transcarotid Neuroprotection System. The carotid artery characteristics and configuration of the circle of Willis (CoW) were evaluated by CT angiography. The demographic and clinical characteristics and procedure-related complications were recorded. Logistic regression was used to analyze the independent factors for TCAR eligibility. Results: Of 289 consecutive patients [222 for carotid endarterectomy (CEA) and 67 for transfemoral carotid artery stenting (TF-CAS)] identified, a total of 215 patients (74.4%) met TCAR anatomic eligibility. Specifically, 83.7% had mild common carotid artery (CCA) puncture site plaque, 95.2% had 4-9 mm internal carotid artery diameters, 95.8% had >6 mm CCA diameter, and 98.3% had >5 cm clavicle to carotid bifurcation distance. Those who were female (OR, 5.967; 95% CI: 2.545-13.987; P < 0.001), were of an older age (OR, 1.226; 95% CI: 1.157-1.299; P < 0.001), and higher body mass index (OR, 1.462; 95% CI: 1.260-1.697; P < 0.001) were prone to be associated with TCAR ineligibility. In addition, 71 patients with TCAR eligibility (33.0%) were found to combine with incomplete CoW. A high risk for CEA was found in 29 patients (17.3%) with TCAR eligibility, and a high risk for TF-CAS was noted in nine patients (19.1%) with TCAR eligibility. Overall, cranial nerve injury (CNI) was found in 22 patients after CEA, while 19 of them (11.3%) met TCAR eligibility. Conclusion: A significant proportion of Chinese patients meet the anatomic criteria of TCAR, making TCAR a feasible treatment option in China. Anatomic and some demographic factors play key roles in TCAR eligibility. Further analysis indicates a potential reduction of procedure-related complications in patients with high-risk carotid stenosis under the TCAR procedure.

Propensity score-matched analysis of 1-year outcomes of transcarotid revascularization with dynamic flow reversal, carotid endarterectomy, and transfemoral carotid artery stenting.

OBJECTIVE: Initial studies showed no significant differences in perioperative stroke or death between transcarotid artery revascularization (TCAR) and carotid endarterectomy (CEA) and lower stroke/death rates after TCAR compared with transfemoral carotid artery stenting (TFCAS). This study focuses on the 1-year outcomes of ipsilateral stroke or death after TCAR, CEA, and TFCAS. METHODS: All patients undergoing TCAR, TFCAS, and CEA between September 2016 and December 2019 were identified in the Vascular Quality Initiative (VQI) database. The latest follow-up was September 3, 2020. One-to-one propensity score-matched analysis was performed for patients with available 1-year follow-up data for TCAR vs CEA and for TCAR vs TFCAS. Kaplan-Meier survival and Cox proportional hazard regression analyses were used to evaluate 1-year ipsilateral stroke or death after the three procedures. RESULTS: A total of 41,548 patients underwent CEA, 5725 patients underwent TCAR, and 6064 patients underwent TFCAS during the study period and had recorded 1-year outcomes. The cohorts were well-matched in terms of baseline demographics and comorbidities. Among 4180 TCAR vs CEA matched pairs of patients, there were no significant differences in 30-day stroke, death, and stroke/death. However, TCAR was associated with a lower risk of 30-day stroke/death/myocardial infarction (2.30% vs 3.25%; relative risk, 0.71; 95% confidence interval [CI], 0.55-0.91; P = .008), driven by a lower risk of myocardial infarction (0.55% vs 1.12%; hazard ratio [HR], 0.49; 95% CI, 0.30-0.81; P = .004). At 1 year, no significant difference was observed in the risk of ipsilateral stroke or death (6.49% vs 5.68%; HR, 1.14; 95% CI, 0.95-1.37; P = .157). Among 4036 matched pairs in the TCAR vs TFCAS group, TCAR was also associated with lower risk of perioperative stroke or death compared with TFCAS (1.83% vs 2.55%; HR, 0.72; 95% CI, 0.54-0.96; P = .027). At 1 year, the risks of ipsilateral stroke or death of TCAR and TFCAS were comparable (6.07% vs 7.07%; HR, 0.85; 95% CI, 0.71-1.01; P = .07). Symptomatic status did not modify the association in TCAR vs CEA. However, asymptomatic patients had favorable outcomes with TCAR vs TFCAS at 1 year (HR, 0.78; 95% CI, 0.62-0.98; P = .033). CONCLUSIONS: In this propensity score-matched analysis, no significant differences in ipsilateral stroke/death-free survival were observed between TCAR and CEA or between TCAR and TFCAS. The advantages of TCAR compared with TFCAS seem to be mainly in the perioperative period, which makes it a suitable minimally invasive option for surgically high-risk patients with carotid artery stenosis. Larger studies, with longer follow-up and data on restenosis, are warranted to confirm the mid- and long-term benefits and durability of TCAR.

Outcomes of transfemoral carotid artery stenting and transcarotid artery revascularization for restenosis after prior ipsilateral carotid endarterectomy.

OBJECTIVE: Restenosis after carotid endarterectomy (CEA) poses unique therapeutic challenges, with no specific guidelines available on the operative approach. Traditionally, transfemoral carotid artery stenting (TfCAS) has been regarded as the preferred approach to treating restenosis after CEA. Recently, transcarotid artery revascularization with a flow-reversal neuroprotection system (TCAR) has gained popularity as an effective alternative treatment modality for de novo carotid artery stenosis. The aim of the present study was to compare the contemporary perioperative outcomes of TfCAS and TCAR in patients with prior ipsilateral CEA. METHODS: The Vascular Quality Initiative database was reviewed for patients who had undergone TfCAS and TCAR for restenosis after prior ipsilateral CEA between January 2016 and August 2020. The primary outcome was the 30-day composite outcome of stroke and death. The secondary outcomes included 30-day stroke, transient ischemic attack (TIA), myocardial infarction (MI), death, and composite 30-day outcomes of stroke, death, and TIA, stroke and TIA, and stroke, death, and MI. Multivariable logistic regression models were used to evaluate the outcomes of interest after adjustment for potential confounders and baseline differences between cohorts. RESULTS: Of 3508 patients, 1834 and 1674 had undergone TfCAS and TCAR, respectively. The TCAR cohort was older (mean age, 71.6 years vs 70.2 years; P < .001) and less likely to be symptomatic (27% vs 46%; P < .001), with a greater proportion taking aspirin (92% vs 88%; P = .001), a P2Y12 inhibitor (89% vs 80%; P < .001), and a statin (91% vs 87%; P = .002) compared with the TfCAS cohort. Perioperatively, the TCAR cohort had had lower 30-day composite outcomes of stroke/death (1.6% vs 2.7%; P = .025), stroke/death/TIA (1.8% vs 3.3%; P = .004), and stroke/death/MI (2.1% vs 3.2%; P = .048), primarily driven by lower rates of stroke (1.3% vs 2.3%; P = .031) and TIA (0.2% vs 0.7%; P = .031). Among asymptomatic patients, the incidence of stroke (0.6% vs 1.4%; P = .042) and the composite of stroke/TIA (0.8% vs 1.8%; P = .036) was significantly lower after TCAR than TfCAS, and TCAR was associated with a lower incidence of TIA (0% vs 1%; P = .038) among symptomatic patients. On adjusted analysis, the TCAR cohort had lower odds of TIA (adjusted odds ratio, 0.17; 95% confidence interval, 0.04-0.74; P = .019). CONCLUSIONS: Among patients undergoing carotid revascularization for restenosis after prior ipsilateral CEA, TCAR was associated with decreased odds of 30-day TIA compared with TfCAS. However, the two treatment approaches were similarly safe in terms of the remaining perioperative outcomes, including stroke and death and stroke, death, and MI. Our results support the safety and efficacy of TCAR in this subset of patients deemed at high risk of reintervention.

Risk factors and impact of postoperative hypotension after carotid artery stenting in the Vascular Quality Initiative.

OBJECTIVE: Hypotension is a frequent complication of carotid artery stenting (CAS). Although common, its occurrence is unpredictable, and association with adverse events has not been well defined. The aim of this study was to identify predictors of postoperative hypotension after CAS and the association with stroke/transient ischemic attack (TIA), major adverse cardiac events (MACEs), increased length of stay (LOS), and in-hospital mortality. METHODS: This is a retrospective analysis of all CAS procedures, including transfemoral CAS (TF-CAS) and transcarotid artery revascularization (TCAR), performed in the Vascular Quality Initiative between 2003 and 2018. The primary study end point was postoperative hypotension, defined as hypotension treated with continuous infusion of a vasoactive agent for ≥15 minutes. Secondary end points included any postoperative neurologic events (stroke/TIA), MACEs (myocardial infarction, congestive heart failure, and dysrhythmias), prolonged LOS (>1 day), and in-hospital mortality. Patients' demographics predictive of hypotension were determined by multivariable logistic regression, and a risk score was developed for correlation with outcomes. RESULTS: During the time period of study, 24,699 patients underwent CAS; 19,716 (80%) were TF-CAS, 3879 (16%) were TCAR, and 1104 (4%) were not defined. Fifty-six percent were for symptomatic disease, 75% were for a primary atherosclerotic lesion, and 72% were performed under local or regional anesthesia. Postoperative hypotension occurred in 15% of TF-CAS and 14% of TCAR patients (P = .50). Patients with hypotension (vs no hypotension) had higher rates of stroke/TIA (7.3% vs 2.6%; P < .001), MACEs (9.6% vs 2.1%; P < .001), prolonged LOS (65% vs 28%; P < .001), and in-hospital mortality (2.9% vs 0.7%; P < .001). By multivariable analysis, risk factors associated with hypotension included an atherosclerotic (vs restenotic) lesion (odds ratio, 2.2; 95% confidence interval, 2.0-2.4; P < .001), female sex (1.3 [1.2-1.4]; P < .001), positive stress test result (1.3 [1.2-1.4]; P < .001), age 70 to 79 years (1.1 [1.1-1.3]; P < .002), age >80 years (1.2 [1.1-1.4]; P < .001), history of myocardial infarction or angina (1.3 [1.2-1.4]; P < .001), and an urgent (vs elective) procedure (1.1 [1.0-1.2]; P < .01). A history of hypertension was protective (0.9 [0.8-0.9]; P < .02). A normalized risk score for hypotension was created from the multivariable model. Increasing risk scores correlated directly with rates of adverse events, including postoperative stroke/TIA, MACEs, increased LOS, and increased in-hospital mortality. CONCLUSIONS: Hypotension after CAS is associated with adverse neurologic and cardiac events as well as with prolonged LOS and in-hospital mortality. A scoring tool may be valuable in stratifying patients at risk. Interventions aimed at preventing postoperative hypotension may improve outcomes with CAS.

Protamine use in transfemoral carotid artery stenting is not associated with an increased risk of thromboembolic events.

BACKGROUND: Protamine use in carotid endarterectomy has been shown to be associated with fewer perioperative bleeding complications without higher rates of thromboembolic events. However, the effect of protamine use on complications after transfemoral carotid artery stenting (CAS) is unclear, and concerns remain about thromboembolic events. METHODS: A retrospective review was performed for patients undergoing transfemoral CAS in the Vascular Quality Initiative from March 2005 to December 2018. We assessed in-hospital outcomes using propensity score-matched cohorts of patients who did and did not receive protamine. The primary outcome was in-hospital stroke or death. Secondary outcomes included bleeding complications, stroke, death, transient ischemic attack, myocardial infarction, and congestive heart failure exacerbation. Bleeding complications were categorized as bleeding resulting in intervention or blood transfusions. RESULTS: Of the 17,429 patients undergoing transfemoral CAS, 2697 (15%) patients received protamine. We created 2300 propensity score-matched pairs of patients who did and did not receive protamine. There were no statistically significant differences in stroke or death between the two cohorts (protamine, 2.5%; no protamine, 2.9%; relative risk [RR], 0.85; 95% confidence interval [CI], 0.60-1.21; P = .37). Protamine use was not associated with statistically significant differences in perioperative bleeding complications resulting in interventional treatment (0.9% vs 0.5%; RR, 2.10; 95% CI, 0.99-4.46; P = .05) or blood transfusion (1.2% vs 1.2%; RR, 0.92; 95% CI, 0.53-1.61; P = .78). There were also no statistically significant differences for the individual outcomes of stroke (1.8% vs 2.3%; RR, 0.78; 95% CI, 0.52-1.16; P = .22), death (0.9% vs 0.8%; RR, 1.17; 95% CI, 0.62-2.19; P = .63), transient ischemic attack (1.4% vs 1.3%; RR, 1.10; 95% CI, 0.67-1.82; P = .70), myocardial infarction (0.5% vs 0.4%; RR, 1.20; 95% CI, 0.52-2.78; P = .67), or heart failure exacerbation (1.0% vs 0.9%; RR, 1.05; 95% CI, 0.58-1.90; P = .88). Protamine use in patients presenting with symptomatic carotid stenosis was associated with lower risk of stroke or death (3.0% vs 4.3%; RR, 0.69; 95% CI, 0.47-0.998; P = .048), whereas there were no statistically significant differences in stroke or death with protamine use in asymptomatic patients (1.6% vs 1.0%; RR, 1.63; 95% CI, 0.67-3.92; P = .28). CONCLUSIONS: Heparin reversal with protamine after transfemoral CAS is not associated with an increased risk of thromboembolic events, and its use in symptomatic carotid disease is associated with a lower risk of stroke or death.

The Vascular Quality Initiative 30-day stroke/death risk score calculator after transfemoral carotid artery stenting.

OBJECTIVE: Carotid artery stenting (CAS) was introduced as an alternative carotid revascularization procedure in patients deemed to be at high risk for carotid endarterectomy. Although techniques and selection criteria for patients have dramatically improved, CAS continues to have higher risk of stroke and death in comparison to carotid endarterectomy. Several risk factors are known to be associated with worse outcomes. Whereas knowledge of these independent factors is helpful, clinical decision-making is further refined when these are considered in aggregate. This study aimed to develop a score to predict the risk of stroke/death after transfemoral CAS (TFCAS). METHODS: We analyzed the Vascular Quality Initiative CAS data set from 2010 to 2018. Lesions due to trauma, dissection, or transcarotid artery stenting and cases performed without an embolic protection device were excluded. Univariable and multivariable logistic regression methods with bootstrapping (1000 repetitions) were used to identify predictors associated with 30-day stroke/death. Stepwise backward selection for variables was used to achieve model parsimony. A risk score was made by converting regression coefficients for each predictor to integers from which probability was calculated. Scores were grouped into simplified categories. RESULTS: We identified 10,753 patients undergoing TFCAS during the study period with a combined 30-day stroke/death rate of 4.1%. On multivariable adjustment, independent predictors of 30-day stroke/death included age (odds ratio [OR], 1.05; 95% confidence interval [CI], 1.03-1.06; P < .001), nonwhite race (OR, 1.42; 95% CI, 1.16-1.74; P = .001), diabetes (OR,1.34; 95% CI, 1.08-1.67; P = .01), coronary artery disease (OR, 1.40; 95% CI, 1.13-1.73; P = .001), congestive heart failure (OR, 1.41; 95% CI, 1.07-1.85; P = .02), symptomatic status (OR, 2.11; 95% CI, 1.64-2.72; P < .001), and contralateral occlusion (OR, 1.64; 95% CI, 1.22-2.19; P = .001). On the other hand, preoperative use of statins (OR, 0.074; 95% CI, 0.59-0.93; P = .02) and dual antiplatelet therapy (P2Y12 inhibitors and aspirin; OR, 0.46; 95% CI, 0.32-0.66; P < .001) were associated with a significant reduction in stroke/death after TFCAS. The model had a C statistic of 69.0%. The coefficients of these predictors were used to develop a risk score calculator that estimates the probability of 30-day stroke/death after TFCAS. CONCLUSIONS: In an analysis of 10,753 patients undergoing TFCAS between 2010 and 2018, significant predictors of perioperative stroke or death included old age, nonwhite race, symptomatic status, diabetes, coronary artery disease, congestive heart failure, and contralateral occlusion in addition to perioperative dual antiplatelet therapy and statin use. These variables were used to develop a risk score calculator that estimates the probability of 30-day stroke/death after TFCAS. External validation of this tool in different populations of patients and data sets is warranted to evaluate its predictive performance.