Transcarotid Arterial Revascularization of Symptomatic Internal Carotid Artery Disease: A Systematic Review and Study-Level Meta-Analysis.

BACKGROUND: Transcarotid artery revascularization (TCAR) is an interventional therapy for symptomatic internal carotid artery disease. Currently, the utilization of TCAR is contentious due to limited evidence. In this study, we evaluate the safety and efficacy of TCAR in patients with symptomatic internal carotid artery disease compared with carotid endarterectomy (CEA) and carotid artery stenting (CAS). METHODS: A systematic review was conducted, spanning from January 2000 to February 2023, encompassing studies that used TCAR for the treatment of symptomatic internal carotid artery disease. The primary outcomes included a 30-day stroke or transient ischemic attack, myocardial infarction, and mortality. Secondary outcomes comprised cranial nerve injury and major bleeding. Pooled odds ratios (ORs) for each outcome were calculated to compare TCAR with CEA and CAS. Furthermore, subgroup analyses were performed based on age and degree of stenosis. In addition, a sensitivity analysis was conducted by excluding the vascular quality initiative registry population. RESULTS: A total of 7 studies involving 24 246 patients were analyzed. Within this patient cohort, 4771 individuals underwent TCAR, 12 350 underwent CEA, and 7125 patients underwent CAS. Compared with CAS, TCAR was associated with a similar rate of stroke or transient ischemic attack (OR, 0.77 [95% CI, 0.33-1.82]) and myocardial infarction (OR, 1.29 [95% CI, 0.83-2.01]) but lower mortality (OR, 0.42 [95% CI, 0.22-0.81]). Compared with CEA, TCAR was associated with a higher rate of stroke or transient ischemic attack (OR, 1.26 [95% CI, 1.03-1.54]) but similar rates of myocardial infarction (OR, 0.9 [95% CI, 0.64-1.38]) and mortality (OR, 1.35 [95% CI, 0.87-2.10]). CONCLUSIONS: Although CEA has traditionally been considered superior to stenting for symptomatic carotid stenosis, TCAR may have some advantages over CAS. Prospective randomized trials comparing the 3 modalities are needed.

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.

Association of stroke or death with severity of carotid lesion calcification in patients undergoing carotid artery stenting.

OBJECTIVE: Carotid artery stenting (CAS) for heavily calcified lesions is controversial due to concern for stent failure and increased perioperative stroke risk. However, the degree to which calcification affects outcomes is poorly understood, particularly in transcarotid artery revascularization (TCAR). With the precipitous increase in TCAR use and its expansion to standard surgical-risk patients, we aimed to determine the impact of lesion calcification on CAS outcomes to ensure its safe and appropriate use. METHODS: We identified patients in the Vascular Quality Initiative who underwent first-time transfemoral CAS (tfCAS) and TCAR between 2016 and 2021. Patients were stratified into groups based on degree of lesion calcification: no calcification, 1% to 50% calcification, 51% to 99% calcification, and 100% circumferential calcification or intraluminal protrusion. Outcomes included in-hospital and 1-year composite stroke/death, as well as individual stroke, death, and myocardial infarction outcomes. Logistic regression was used to evaluate associations between degree of calcification and these outcomes. RESULTS: Among 21,860 patients undergoing CAS, 28% patients had no calcification, 34% had 1% to 50% calcification, 35% had 51% to 99% calcification, and 3% had 100% circumferential calcification/protrusion. Patients with 51% to 99% and circumferential calcification/protrusion had higher odds of in-hospital stroke/death (odds ratio [OR], 1.3; 95% confidence interval [CI], 1.02-1.6; P = .034; OR, 1.9; 95% CI, 1.1-2.9; P = .004, respectively) compared with those with no calcification. Circumferential calcification was also associated with increased risk for in-hospital myocardial infarction (OR, 3.5; 95% CI, 1.5-8.0; P = .003). In tfCAS patients, only circumferential calcification/protrusion was associated with higher in-hospital stroke/death odds (OR, 2.0; 95% CI, 1.2-3.4; P = .013), whereas for TCAR patients, 51% to 99% calcification was associated with increased odds of in-hospital stroke/death (OR, 1.5; 95% CI, 1.1-2.2; P = .025). At 1 year, circumferential calcification/protrusion was associated with higher odds of ipsilateral stroke/death (12.4% vs 6.6%; hazard ratio, 1.64; P = .002). CONCLUSIONS: Among patients undergoing CAS, there is an increased risk of in-hospital stroke/death for lesions with >50% calcification or circumferential/protruding plaques. Increasing severity of carotid lesion calcification is a significant risk factor for stroke/death in patients undergoing CAS, regardless of approach.

Impact of the type of anesthesia on adverse events during transcarotid artery revascularization.

OBJECTIVE: The use of local or regional anesthesia (LRA) is encouraged during transcarotid artery revascularization (TCAR) because the procedure is performed through a small incision. LRA permits neurologic evaluation during the procedure and may reduce periprocedural cardiac morbidity compared with general anesthesia (GA). There is limited and conflicting information regarding the preferred anesthesia to use during TCAR. We compared periprocedural clinical and technical complications, and intraprocedural performance metrics of TCAR performed under GA vs LRA. METHODS: Patient, lesion, physician, and procedural information was collected in a worldwide quality assurance program of consecutive TCAR procedures. A composite clinical adverse event rate (death, stroke, transient ischemic attack, myocardial infarction) and a composite technical adverse event rate (aborted procedure, conversion to carotid endarterectomy, bleeding, dissection, cranial-nerve injury, device failure) in the periprocedural period were computed. Four intraprocedural performance measures (flow-reversal time, fluoroscopy time, contrast volume, and skin-to-skin time) were recorded. Deidentified data were analyzed independently at the Center for Vascular Research, University of Maryland. Poisson regressions were used to assess the impact of anesthesia type on adverse event rates. Linear regressions were used to compare performance measures. RESULTS: A total of 27,043 TCARs were performed by 1456 physicians between 2012 and 2021. A majority of patients (83%) received GA, and this proportion increased over time (R2 = 0.74; P < .0001). Some physicians (33.4%) used LRA in some of their procedures; only 2.7% used LRA in all of their procedures. Clinical risk factors were more common in the LRA group (P < .0001) and anatomic risk factors in the GA group (P < .0001); these differences were adjusted for in subsequent analyses. LRA was more likely to be used by vascular surgeons and by physicians with higher prior transfemoral carotid stenting experience (P < .0001). When comparing GA vs LRA, clinical adverse events (1.49%; 95% confidence interval [CI], 1.3-1.8 vs 1.55%; 95% CI, 1.2-2.0; P = .78), technical adverse events (5.6%; 95% CI, 5.2-6.2 vs 5.3%; 95% CI, 4.5-6.3; P = .47), and intraprocedural performance measures did not differ by type of anesthesia. CONCLUSIONS: Almost two-thirds of physicians performed TCAR exclusively under GA, and the overall proportion of procedures performed under GA increased over time. A larger fraction of patients with severe medical risk factors received LRA vs GA, whereas a larger fraction of patients with anatomic risk-factors received GA. Periprocedural clinical and technical adverse events did not differ by type of anesthesia. Intraprocedural performance metrics that drive procedural cost were similar between groups; potential differences in procedural cost driven by anesthetic choice require further study.

Higher stroke risk after carotid endarterectomy and transcarotid artery revascularization is associated with relative surgeon volume ratio.

OBJECTIVE: Adoption of transcarotid artery revascularization (TCAR) by surgeons has been variable, with some still performing traditional carotid endarterectomy (CEA), whereas others have shifted to mostly TCAR. Our goal was to evaluate the association of relative surgeon volume of CEA to TCAR with perioperative outcomes. METHODS: The Vascular Quality Initiative CEA and carotid artery stent registries were analyzed from 2021 to 2023 for symptomatic and asymptomatic interventions. Surgeons participating in both registries were categorized in the following CEA to CEA+TCAR volume percentage ratios: 0.25 (majority TCAR), 0.26 to 0.50 (more TCAR), 0.51 to 0.75 (more CEA), and 0.76 to 1.00 (majority CEA). Primary outcomes were rates of perioperative ipsilateral stroke, death, cranial nerve injury, and return to the operating room for bleeding. RESULTS: There were 50,189 patients who underwent primary carotid revascularization (64.3% CEA and 35.7% TCAR). CEA patients were younger (71.1 vs 73.5 years, P < .001), with more symptomatic cases, less coronary artery disease, diabetes, and lower antiplatelet and statin use (all P < .001). TCAR patients had lower rates of smoking, obesity, and dialysis or renal transplant (all P < .001). Postoperative stroke after CEA was significantly impacted by the operator CEA to TCAR volume ratio (P = .04), with surgeons who perform majority TCAR and more TCAR having higher postoperative ipsilateral stroke (majority TCAR odds ratio [OR]: 2.15, 95% confidence interval [CI]: 1.16-3.96, P = .01; more TCAR OR: 1.42, 95% CI: 1.02-1.96, P = .04), as compared with those who perform majority CEA. Similarly, postoperative stroke after TCAR was significantly impacted by the CEA to TCAR volume ratio (P = .02), with surgeons who perform majority CEA and more CEA having higher stroke (majority CEA OR: 1.51, 95% CI: 1.00-2.27, P = .05; more CEA OR: 1.50, 95% CI: 1.14-2.00, P = .004), as compared with those who perform majority TCAR. There was no association between surgeon ratio and perioperative death, cranial nerve injury, and return to the operating room for bleeding for either procedure. CONCLUSIONS: The relative surgeon CEA to TCAR ratio is significantly associated with perioperative stroke rate. Surgeons who perform a majority of one procedure have a higher stroke rate in the other. Surgeons offering both operations should maintain a balanced practice and have a low threshold to collaborate as needed.

Recent advances and controversial issues in the optimal management of asymptomatic carotid stenosis.

OBJECTIVE: The optimal management of patients with asymptomatic carotid stenosis (AsxCS) is enduringly controversial. We updated our 2021 Expert Review and Position Statement, focusing on recent advances in the diagnosis and management of patients with AsxCS. METHODS: A systematic review of the literature was performed up to August 1, 2023, using PubMed/PubMed Central, EMBASE and Scopus. The following keywords were used in various combinations: "asymptomatic carotid stenosis," "carotid endarterectomy" (CEA), "carotid artery stenting" (CAS), and "transcarotid artery revascularization" (TCAR). Areas covered included (i) improvements in best medical treatment (BMT) for patients with AsxCS and declining stroke risk, (ii) technological advances in surgical/endovascular skills/techniques and outcomes, (iii) risk factors, clinical/imaging characteristics and risk prediction models for the identification of high-risk AsxCS patient subgroups, and (iv) the association between cognitive dysfunction and AsxCS. RESULTS: BMT is essential for all patients with AsxCS, regardless of whether they will eventually be offered CEA, CAS, or TCAR. Specific patient subgroups at high risk for stroke despite BMT should be considered for a carotid revascularization procedure. These patients include those with severe (≥80%) AsxCS, transcranial Doppler-detected microemboli, plaque echolucency on Duplex ultrasound examination, silent infarcts on brain computed tomography or magnetic resonance angiography scans, decreased cerebrovascular reserve, increased size of juxtaluminal hypoechoic area, AsxCS progression, carotid plaque ulceration, and intraplaque hemorrhage. Treatment of patients with AsxCS should be individualized, taking into consideration individual patient preferences and needs, clinical and imaging characteristics, and cultural, ethnic, and social factors. Solid evidence supporting or refuting an association between AsxCS and cognitive dysfunction is lacking. CONCLUSIONS: The optimal management of patients with AsxCS should include BMT for all individuals and a prophylactic carotid revascularization procedure (CEA, CAS, or TCAR) for some asymptomatic patient subgroups, additionally taking into consideration individual patient needs and preference, clinical and imaging characteristics, social and cultural factors, and the available stroke risk prediction models. Future studies should investigate the association between AsxCS with cognitive function and the role of carotid revascularization procedures in the progression or reversal of cognitive dysfunction.

Investigation of the weekend effect on perioperative complications and mortality after carotid revascularization.

OBJECTIVE: Outcomes for weekend surgical interventions are associated with higher rates of mortality and complications than weekday interventions. Although prior investigations have reported the "weekend effect" for carotid endarterectomy (CEA), this association remains unclear for transcarotid artery revascularization (TCAR) and transfemoral carotid artery stenting (TFCAS). We investigated the weekend effect for all three carotid revascularization methods. METHODS: We queried the Vascular Quality Initiative for patients who underwent CEA, TCAR, and TFCAS between 2016 and 2022. χ2 and logistic regression modeling analyzed outcomes including in-hospital stroke, death, myocardial infarction, and 30-day mortality by weekend vs weekday intervention. Backward stepwise regression was used to identify significant confounding variables and was ultimately included in each final logistic regression model. Logistic regression of outcomes was substratified by symptomatic status. Secondary multivariable analysis compared outcomes between the three revascularization methods by weekend vs weekday interventions. RESULTS: A total of 155,962 procedures were analyzed including 103,790 CEA, 31,666 TCAR, and 20,506 TFCAS. Of these, 1988 CEA, 246 TCAR, and 820 TFCAS received weekend interventions. Logistic regression demonstrated no significant differences for TCAR and increased odds of in-hospital stroke/death/myocardial infarction for CEA (odds ratio [OR]: 1.31, 95% confidence interval [CI]: 1.04-1.65) and TFCAS (OR: 1.46, 95% CI: 1.09-1.96) weekend procedures. Asymptomatic TCAR patients had nearly triple the odds of 30-day mortality (OR: 2.85, 95% CI: 1.06-7.68, P = .038). Similarly, odds of in-hospital death were nearly tripled for asymptomatic CEA (OR: 2.89, 95% CI: 1.30-6.43, P = .009) and asymptomatic TFCAS (OR: 2.78, 95% CI: 1.34-5.76, P = .006) patients. Secondary analysis demonstrated that CEA and TCAR had no significant differences for all outcomes. TFCAS was associated with increased odds of stroke and death compared with CEA and TCAR. CONCLUSIONS: In this observational cohort study, we found that weekend carotid revascularization is associated with increased odds of complications and mortality. Furthermore, asymptomatic weekend patients perform worse in the CEA and TFCAS procedural groups. Among the three revascularization methods, TFCAS is associated with the highest odds of perioperative stroke and mortality. As such, our findings suggest that TFCAS procedures should be avoided over the weekend in favor of CEA or TCAR. In patients who are poor candidates for CEA, TCAR offers the lowest morbidity and mortality for weekend procedures.

Patient decision-making in the era of transcarotid artery revascularization.

OBJECTIVE: The National Coverage Determination on carotid stenting by Medicare in October 2023 stipulates that patients participate in a shared decision-making (SDM) conversation with their proceduralist before an intervention. However, to date, there is no validated SDM tool that incorporates transcarotid artery revascularization (TCAR) into its decision platform. Our objective was to elicit patient and surgeon experiences and preferences through a qualitative approach to better inform the SDM process surrounding carotid revascularization. METHODS: We performed longitudinal perioperative semistructured interviews of 20 participants using purposive maximum variation sampling, a qualitative technique designed for identification and selection of information-rich cases, to define domains important to participants undergoing carotid endarterectomy or TCAR and impressions of SDM. We also performed interviews with nine vascular surgeons to elicit their input on the SDM process surrounding carotid revascularization. Interview data were coded and analyzed using inductive content analysis coding. RESULTS: We identified three important domains that contribute to the participants' ultimate decision on which procedure to choose: their individual values, their understanding of the disease and each procedure, and how they prefer to make medical decisions. Participant values included themes such as success rates, "wanting to feel better," and the proceduralist's experience. Participants varied in their desired degree of understanding of carotid disease, but all individuals wished to discuss each option with their proceduralist. Participants' desired medical decision-making style varied on a spectrum from complete autonomy to wanting the proceduralist to make the decision for them. Participants who preferred carotid endarterectomy felt outcomes were superior to TCAR and often expressed a desire to eliminate the carotid plaque. Those selecting TCAR felt it was a newer, less invasive option with the shortest procedural and recovery times. Surgeons frequently noted patient factors such as age and anatomy, as well as the availability of long-term data, as reasons to preferentially select one procedure. For most participants, their surgeon was viewed as the most important source of information surrounding their disease and procedure. CONCLUSIONS: SDM surrounding carotid revascularization is nuanced and marked by variation in patient preferences surrounding autonomy when choosing treatment. Given the mandate by Medicare to participate in a SDM interaction before carotid stenting, this analysis offers critical insights that can help to guide an efficient and effective dialog between patients and providers to arrive at a shared decision surrounding therapeutic intervention for patients with carotid disease.

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.

Carotid endarterectomy and transcarotid artery revascularization can be performed with acceptable morbidity and mortality in patients with chronic kidney disease.

OBJECTIVE: Patients with chronic kidney disease (CKD) are considered a high-risk population, and the optimal approach to the treatment of carotid disease remains unclear. Thus, we compared outcomes following carotid revascularization for patients with CKD by operative approach of carotid endarterectomy (CEA), transfemoral carotid artery stenting (TFCAS), and transcarotid arterial revascularization (TCAR). METHODS: The Vascular Quality Initiative was analyzed for patients undergoing carotid revascularizations (CEA, TFCAS, and TCAR) from 2016 to 2021. Patients with normal renal function (estimated glomular filtration rate >90 mL/min/1.72 m2) were excluded. Asymptomatic and symptomatic carotid stenosis were assessed separately. Preoperative demographics, operative details, and outcomes of 30-day mortality, stroke, myocardial infarction (MI), and composite variable of stroke/death were compared. Multivariable analysis adjusted for differences in groups, including CKD stage. RESULTS: A total of 90,343 patients with CKD underwent revascularization (CEA, n = 66,870; TCAR, n = 13,459; and TFCAS, n = 10,014; asymptomatic, 63%; symptomatic, 37%). Composite 30-day mortality/stroke rates were: asymptomatic: CEA, 1.4%; TCAR, 1.2%; TFCAS, 1.8%; and symptomatic: CEA, 2.7%; TCAR, 2.3%; TFCAS, 3.7%. In adjusted analysis, TCAR had lower 30-day mortality compared with CEA (asymptomatic: adjusted odds ratio [aOR], 0.4; 95% confidence interval [CI], 0.3-0.7; symptomatic: aOR, 0.5; 95% CI, 0.3-0.7), and no difference in stroke, MI, or the composite outcome of stroke/death in both symptom cohorts. TCAR had lower risk of other cardiac complications compared with CEA in asymptomatic patients (aOR, 0.7; 95% CI, 0.6-0.9) and had similar risk in symptomatic patients. Compared with TFCAS, TCAR patients had lower 30-day mortality (asymptomatic: aOR, 0.5; 95% CI, 0.2-0.95; symptomatic: aOR, 0.3; 95% CI, 0.2-0.4), stroke (symptomatic: aOR, 0.7; 95% CI, 0.5-0.97), and stroke/death (asymptomatic: aOR, 0.7; 95% CI, 0.5-0.97; symptomatic: aOR, 0.6; 95% CI, 0.4-0.7), but no differences in MI or other cardiac complications. Patients treated with TFCAS had higher 30-day mortality (aOR, 1.8; 95% CI, 1.2-2.5) and stroke risk (aOR, 1.3; 95% CI, 1.02-1.7) in symptomatic patients compared with CEA. There were no differences in MI or other cardiac complications. CONCLUSIONS: Among patients with CKD, TCAR and CEA showed rates of stroke/death less than 2% for asymptomatic patients and less than 3% for symptomatic patients. Given the increased risk of major morbidity and mortality, TFCAS should not be performed in patients with CKD who are otherwise anatomic candidates for TCAR or CEA.

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.

Non-White Patients Have a Higher Risk of Stroke Following Transcarotid Artery Revascularization.

INTRODUCTION: Carotid artery revascularization has traditionally been performed by either a carotid endarterectomy or carotid artery stent. Large data analysis has suggested there are differences in perioperative outcomes with regards to race, with non-White patients (NWP) having worse outcomes of stroke, restenosis and return to the operating room (RTOR). The introduction of transcarotid artery revascularization (TCAR) has started to shift the paradigm of carotid disease treatment. However, to date, there have been no studies assessing the difference in postoperative outcomes after TCAR between racial groups. METHODS: All patients from 2016 to 2021 in the Vascular Quality Initiative who underwent TCAR were included in our analysis. Patients were split into two groups based on race: individuals who identified as White and a second group that comprised all other races. Demographic and clinical variables were compared using Student's t-Test and chi-square test of independence. Logistic regression analysis was performed to determine the impact of race on perioperative outcomes of stroke, myocardial infarction (MI), death, restenosis, RTOR, and transient ischemic attack (TIA). RESULTS: The cohort consisted of 22,609 patients: 20,424 (90.3%) White patients and 2185 (9.7%) NWP. After adjusting for sex, diabetes, hypertension, coronary artery disease, history of prior stroke or TIA, symptomatic status, and high-risk criteria at time of TCAR, there was a significant difference in postoperative stroke, with 63% increased risk in NWP (odds ratio = 1.63, 95% confidence interval: 1.11-2.40, P = 0.014). However, we found no significant difference in the odds of MI, death, postoperative TIA, restenosis, or RTOR when comparing NWP to White patients. CONCLUSIONS: This study demonstrates that NWP have increased risk of stroke but similar outcomes of death, MI, RTOR and restenosis following TCAR. Future studies are needed to elucidate and address the underlying causes of racial disparity in carotid revascularization.

Postoperative Bleeding Complications are Common Among Patients Undergoing Transcarotid Artery Revascularization.

BACKGROUND: Current practice guidelines recommend dual antiplatelet therapy for at least 30 days postoperatively after transcarotid artery revascularization (TCAR) to promote stent patency. However, many patients are already taking other antithrombotic medications. The optimal pharmacologic regimen in this patient population remains unclear, especially as it pertains to postoperative bleeding complications. METHODS: All TCAR procedures performed at a large academic medical center from January 1, 2017 to April 30, 2023 were identified via current procedural terminology codes and retrospectively reviewed via electronic medical records. Data were collected on patient demographics, procedural details, postoperative complications, and antithrombotic regimen. Bleeding complications were categorized as surgical and non-surgical, which included any bleeding diatheses that were not related to the neck incision, such as epistaxis, hematuria, melena, or non-cervical hematoma. RESULTS: A total of 116 TCAR procedures were performed. The 30-day incidence of bleeding complications was 12.1% (n=14), which included 8 (6.9%) symptomatic neck hematomas and 6 (5.2%) non-surgical site bleeding complications. Aside from patient age (median 72 y [66-79] vs 79 y [70.5-88], p=0.03), demographics, medical comorbidities, surgical indication, risk-related indication for TCAR, and inpatient/outpatient status were similar between patients who experienced bleeding versus no bleeding complications. Patients who developed bleeding complications experienced higher thirty-day hospital readmission (42.9% vs 9.8%, p<0.001) and reintervention rates (21.4% vs 2.0%, p<0.001) and trended towards longer postoperative length of stay (1.5 d [1-3] vs 1 [1-2] d, p=0.07). Reasons for readmission (n=16) included: epistaxis (1), hematuria (1), headache and melena (1), melena and myocardial infarction (1), fall (1), headache (1), dyspnea (5), delirium (1), diarrhea (1), atrial fibrillation (1), and neck hematoma (1); one patient did not have a readmission reason documented. Reinterventions (n=6) included: neck hematoma evacuation (2), epistaxis cauterization (1), emergent cricothyroidotomy (1), and repeat carotid stenting (1). The management of antithrombotic medications during bleeding events were highly variable amongst providers (11 patients with nothing held, one apixaban held, one aspirin held, one clopidogrel held), however, no patients suffered carotid stent thrombosis. CONCLUSIONS: Bleeding complications are common within 30 days of TCAR and frequently result in unplanned hospital readmission and reintervention. There is significant provider-level variability in management of antithrombotic medications during these events. These data highlight need for evidence-based guidelines for the optimal pharmacologic strategy for patients post-TCAR who develop bleeding complications.

Racial differences in adoption and outcomes of transcarotid artery revascularization among high-risk adults with carotid artery stenosis.

INTRODUCTION: Differential access to new technologies may contribute to racial disparities in surgical outcomes but has not been well-studied in the treatment of carotid artery stenosis. We examined race-based differences in adoption and outcomes of transcarotid artery revascularization (TCAR) among high-risk non-Hispanic (NH) NH Black and NH white adults undergoing carotid revascularization. METHODS: We conducted a retrospective analysis of TCAR, transfemoral carotid artery stenting (TF-CAS), and carotid endarterectomy (CEA) procedures performed for carotid artery stenosis from 1/2015 to 7/2023 in the Vascular Quality Initiative. NH Black and NH white adults were included if they met Centers for Medicare & Medicaid Services high-risk criteria. Hospitals and physicians were categorized as TCAR-capable if they had previously performed at least one TCAR prior to the time of a given procedure. We fit logistic and linear regressions, adjusted a priori for common demographic, clinical, and disease characteristics, to estimate associations of race with receipt of TCAR (versus CEA or TF-CAS), and to explore associations between race, hospital and physician characteristics, and perioperative composite stroke/death/myocardial infarction. RESULTS: Of 159,471 high-risk patients undergoing revascularization for carotid artery stenosis (mean age 72 years, 38.5% female, 5.3% NH Black), 28,722 (18.0%) received TCAR, including 16.9% of NH Black adults and 18.1% of NH white adults (P<0.001). After controlling for patient and disease characteristics, NH Black patients were less likely than NH white patients to receive TCAR (aOR 0.92, 95% CI 0.87 to 0.99). The use of TCAR did not vary by race among patients treated at TCAR-capable hospitals (aOR 0.98, 95% CI 0.91 to 1.05) or by TCAR-capable physicians (aOR 1.01, 95% CI 0.93 to 1.10); however, NH Black race was associated with lower odds of receiving treatment in these settings (TCAR-capable hospital: aOR 0.93 [0.88 to 0.98]; TCAR-capable physician: aOR 0.92 [0.87 to 0.98]). NH Black race was associated with higher odds of stroke/death/MI in the full cohort (aOR 1.18, 95% CI 1.03 to 1.36), but not in the subgroup of patients who received TCAR (aOR 0.87, 95% CI 0.56 to 1.34). CONCLUSIONS: TCAR attenuated racial disparities in perioperative morbidity and mortality associated with carotid revascularization, but NH Black adults were less likely than NH white adults to receive TCAR. Relatively worse access for NH Black adults to technologically-advanced treatment settings may partially explain the broader persistence of race-based differences in carotid revascularization treatment patterns and outcomes.

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.

Discrepancies in clavicle-to-carotid bifurcation length measurements for transcarotid artery revascularization using different imaging modalities.

OBJECTIVE: Transcarotid artery revascularization (TCAR) has emerged as an effective method for carotid artery stenting. However, anatomic eligibility for TCAR is most often limited by an inadequate clavicle-to-carotid bifurcation length of <5 cm. Preoperative clavicle-to-carotid bifurcation distances may be underestimated when using conventional straight-line measurements on computed tomographic angiography (CTA) imaging. We therefore compared clavicle-to-carotid bifurcation lengths as measured by straight-line CTA, center-line CTA, and intraoperative duplex ultrasound (US), to assess potential differences. METHODS: We conducted a single-center, retrospective review of consecutive TCAR procedures performed between 2016 and 2019 for atherosclerotic carotid disease. For each patient, we compared clavicle-to-carotid bifurcation lengths measured by straight-line CTA, center-line CTA using TeraRecon image reconstruction, and intraoperative duplex US with neck extension and rotation. We further assessed patient and imaging characteristics in individuals with a ≥0.5 cm difference among the measurement methods. In particular, common carotid artery (CCA) tortuosity, defined as the inability to visualize the entire CCA from clavicle to carotid bifurcation on both a single coronal and sagittal imaging cut, was examined as a contributing factor for these discrepancies. RESULTS: Of the 70 TCAR procedures identified, 46 had all three imaging modalities available for review. The median clavicle-to-carotid bifurcation length was found to be 6.4 cm (interquartile range [IQR], 5.4-6.7 cm) on straight-line CTA, 7.0 cm (IQR, 6.0-7.5 cm) on intraoperative duplex US, and 7.2 cm (IQR, 6.5-7.5 cm) on center-line CTA (P < .001). Patients with a ≥0.5 cm difference between their straight-line CTA and either their intraoperative duplex US or center-line CTA measurements were more likely to have tortuous CCAs (60.0% vs 19.1%; P = .01; 51.4% vs 0.0%; P = .01). There were no notable differences in age, gender, prior neck/cervical spine surgery, or neck immobility among these individuals. In patients with tortuous CCAs, duplex US and center-line CTA measurements added 1.0 cm (IQR, 0.6-1.5 cm) and 1.1 cm (IQR, 0.9-1.6 cm) more in length than straight-line CTA measurements, respectively. There was a strong linear correlation between the additional lengths provided by duplex US measurements and those provided by center-line CTA measurements for each individual within the tortuous CCA group (r = 0.83). CONCLUSIONS: The use of straight-line CTA during preoperative planning can underestimate the clavicle-to-carotid bifurcation lengths in patients undergoing carotid revascularization, particularly in those with tortuous CCAs. Both duplex US performed with extended-neck surgical positioning and center-line CTA provide similar and longer carotid length measurements, and should be utilized in patients with tortuous carotid vessels to better determine TCAR anatomic eligibility.

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.

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.

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.