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

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

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.

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.

The Effects of Carotid Revascularization on 1-Year Cognitive Performance in Patients With Carotid Artery Stenosis.

PURPOSE: The impact of carotid revascularization on cognitive function for patients with severe carotid artery stenosis remains uncertain. This study is aimed to investigate the 1-year neurocognitive outcomes of patients who accept carotid revascularization and identify the risk factors associated with postoperative cognitive decline. METHODS: From April 2019 to April 2021, patients with ≥70% carotid artery stenosis who were treated with carotid endarterectomy (CEA) or carotid artery stenting (CAS) were recruited for this study. The Montreal Cognitive Assessment (MoCA) instrument was used to evaluate cognitive function preoperatively and at 3, 6, and 12 months postoperatively. Logistic regression analysis was built to identify potential risk factors for postoperative long-term cognitive decline. RESULTS: A total of 89 patients who met the criteria were enrolled and completed 1-year follow-up. At 3, 6, and 12 months after carotid revascularization, the total MoCA score, attention, language fluency, and delayed recall score were significantly improved compared with the baseline scores (p<0.05). At 12 months, there was also a significant improvement in cube copying compared with baseline (p=0.034). Logistic regression analysis showed that the advancing age, left side, and symptomatic carotid artery stenosis were independent risk factors for cognitive deterioration at 12 months after surgery. CONCLUSIONS: Overall, carotid revascularization has a beneficial effect on cognition function in patients with severe carotid artery stenosis, while advancing age, left side, and symptomatic carotid artery stenosis were significantly related to a decreased cognitive score after carotid revascularization. CLINICAL IMPACT: This study focused on the changes in cognitive function within 1 year after carotid revascularization in patients with severe carotid stenosis. Of course, carotid revascularization can improve the cognition function in these patients. On the other hand, we found the advancing age, left side and symptomatic carotid artery stenosis were significantly associated with decreased cognitive scores at 1 year after carotid revascularization, which suggests that clinicians may need to be aware of patients with these characteristics.

Incidence of myocardial injury in patients submitted to carotid endarterectomy.

Myocardial injury following noncardiac surgery (MINS) is associated with higher mortality and major adverse cardiovascular event rates in the short- and long-term in patients undergoing carotid endarterectomy (CEA). However, its incidence is still unclear in this subset of patients. Therefore, this systematic review with meta-analysis aims to determine the incidence of MINS in patients undergoing CEA. Three electronic databases MEDLINE, Scopus, and Web of Science were used to search for studies assessing the occurrence of MINS in the postoperative setting of patients undergoing CEA. The incidence of MINS was pooled by random-effects meta-analysis, with sources of heterogeneity being explored by meta-regression and subgroup analysis (general anesthesia vs. regional anesthesia). Assessment of studies' quality was performed using National Heart, Lung, and Blood Institute Study Quality Assessment Tool, and Risk of Bias 2 tools. Twenty studies were included, with a total of 117,933 participants. Four of them were RCTs, while the remaining were cohort studies. All observational cohorts had an overall high risk of bias, except for Pereira Macedo et al. Three of them had repeated population, thus only data from the most recent one was considered. On the other hand, all RCT had an overall low risk of bias. In patients under regional anesthesia, the incidence of MINS in primary studies ranged between 2% and 15.3%, compared to 0-42.5% for general anesthesia. The meta-analytical incidence of MINS after CEA was of 6.3% [95% CI 2.0-10.6%], but severe heterogeneity was observed (I2=99.1%). MINS appears to be relatively common among patients undergoing CEA. The observed severe heterogeneity points to the need for further larger studies adopting consistent definitions of MINS and equivalent cut-off values.

Loss of follow-up after carotid revascularization is associated with worse long-term stroke and death.

OBJECTIVES: Society for Vascular Surgery practice guidelines recommend surveillance with duplex ultrasound scanning at baseline (within 3 months from discharge), every 6 months for 2 years, and annually afterward following carotid endarterectomy or carotid artery stenting. There is a growing concern regarding the significance of postoperative follow-up after several vascular procedures. We sought to determine whether 1-year loss to follow-up (LTF) after carotid revascularization was associated with worse outcomes in the Vascular Quality Initiative (VQI) linked to Vascular Implant Surveillance and Interventional Outcomes Network (VISION) database. METHODS: All patients who underwent carotid revascularization in the VQI VISION database between 2003 and 2016 were included. LTF was defined as failure to complete 1-year follow-up in the VQI long-term follow-up dataset. Data about stroke and mortality were captured in the VISION dataset using a list of Current Procedural Terminology, International Classification of Diseases (Ninth Revision), and International Classification of Diseases (Tenth Revision) codes linked to index procedures in VQI. Kaplan-Meier life-table methods and Cox proportional hazard modeling were used to compare 5- and 10-year outcomes between patients with no LTF and those who were LTF. RESULTS: A total of 58,840 patients were available for analysis. The 1-year LTF rate was 43.8%. Patients who were LTF were older and more frequently symptomatic, with chronic obstructive pulmonary diseases, chronic kidney diseases, and congestive heart failure. Also, patients who underwent carotid artery stenting were more likely to be LTF compared with carotid endarterectomy patients (54.5% vs 42.3%; P < .001). The incidence of postoperative (30 days) stroke was higher in the LTF group (2.9% vs 1.7%; P < .001). Cox regression analysis revealed that LTF was associated with an increased risk of long-term stroke at 5 years (hazard ratio [HR]: 1.4, 95% confidence interval [CI]: 1.2-1.6; P < .001) and 10 years (HR: 1.3, 95% CI: 1.2-1.5; P < .001). It was also associated with significantly higher mortality at 5 years (HR: 2.5, 95% CI: 2.3-2.8; P < .001) and 10 years (HR: 2.2, 95% CI: 1.9-2.5; P < .001). Stroke or death was significantly worse in the LTF group at 5 years (HR: 2.3, 95% CI: 2.1-2.5; P < .001) and up to 10 years (HR: 2.02, 95% CI: 1.8-2.3; P < .001). CONCLUSIONS: One-year follow-up after carotid revascularization procedures was found to be associated with better stroke- and mortality-free survival. Surgeons should emphasize the importance of follow-up to all patients who undergo carotid revascularization, especially those with multiple comorbidities and postoperative neurological complications.

Statin therapy is associated with improved perioperative outcomes and long-term mortality following carotid revascularization in the Vascular Quality Initiative.

OBJECTIVE: Statin therapy is the standard of care for patients with carotid artery stenosis given its proven cardiovascular benefits. However, the impact of statin therapy on outcomes in patients undergoing carotid revascularization in the Vascular Quality Initiative has not yet been evaluated. Therefore, our aim was to investigate the association of statin therapy with outcomes following carotid endarterectomy (CEA), transfemoral carotid artery stenting (tfCAS), and transcarotid artery revascularization (TCAR). METHODS: We identified all patients who underwent CEA, tfCAS, or TCAR in the Vascular Quality Initiative registry from January 2016 to September 2021. To compare outcomes, we stratified patients by procedure type and created 1:1 propensity score-matched cohorts of patients who received no preoperative statin therapy (within 36 hours of procedure) versus those who received preoperative statin therapy. Propensity scores incorporated demographic characteristics, comorbidities, carotid symptom status, preoperative medications, and physician and hospital procedural experience. The primary outcome was a composite end point of in-hospital stroke and/or death. As a secondary analysis, we performed repeat propensity score-matching by postoperative statin use (prescribed at discharge) and assessed 5-year mortality. Relative risks (RR) and hazard ratios (HR) were calculated using log binomial regression and Cox regression, respectively. RESULTS: Among 97,835 CEA, 20,303 tfCAS, and 22,371 TCAR patients, 15%, 17%, and 10% of patients did not receive preoperative statin therapy, respectively. Compared with statin use, no statin use was associated with a higher risk of in-hospital stroke or death among 13,434 matched CEA patients (no statin, 1.7% vs statin, 1.4%; RR, 1.2; 95% confidence interval [CI], 1.02-1.5) and among 2707 matched tfCAS patients (4.8% vs 2.8%; RR, 1.7; 95% CI, 1.3-2.3). However, there was no difference for this outcome by statin use among 2089 matched TCAR patients (1.8% vs 1.6%; RR, 1.1; 95% CI, 0.7-1.8). At 5 years, no statin therapy at discharge was associated with higher 5-year mortality after CEA (15% vs 10%; HR, 1.8; 95% CI, 1.6-2) and tfCAS (18% vs 14%; HR, 1.5; 95% CI, 1.2-1.8), but there was no difference after TCAR (14% vs 11%; HR, 1.3; 95% CI, 0.9-1.8). CONCLUSIONS: Compared with statin use, no statin use was associated with a higher risk of in-hospital stroke or death and 5-year mortality among CEA and tfCAS patients. Although there was no significant difference in outcomes among TCAR patients, this may in part be due to lower statistical power in this cohort. Overall, statin therapy is essential in the short- and long-term management of patients undergoing carotid revascularization. Our findings not only support current Society for Vascular Surgery recommendations for statin therapy in patients undergoing carotid revascularization, but they also highlight an important opportunity for quality improvement.

Impact of neighborhood social disadvantage on carotid artery disease presentation, management, and discharge outcomes.

OBJECTIVE: Recent studies have highlighted that race and socioeconomic status serve as important determinants of disease presentation and perioperative outcomes in carotid artery disease. However, these investigations only focus on individual factors of social disadvantage, and fail to account for community factors that may drive disparities. Area Deprivation Index (ADI) is a validated measure of neighborhood adversity that offers a more comprehensive assessment of social disadvantage. We examined the impact of ADI ranking on carotid artery disease severity, management, and postoperative outcomes. METHODS: We identified patients who underwent carotid endarterectomy (CEA), transfemoral carotid artery stenting (tfCAS), and transcarotid artery revascularization (TCAR) in the Vascular Quality Initiative registry between 2016 and 2020. Patients were assigned ADI scores of 1 to 100 based on zip codes and grouped into quintiles, with higher quintiles reflecting increasing adversity. Outcomes assessed included disease presentation, intervention type, and discharge patterns. Logistic regression was used to evaluate independent associations between ADI quintiles and these outcomes. RESULTS: Among 91,904 patients undergoing carotid revascularization, 9811 (10.7%) were in the lowest ADI quintile (Q1), 18,905 (20.6%) in Q2, 25,442 (27.7%) in Q3, 26,099 (28.4%) in Q4, and 11,647 (12.7%) in Q5. With increasing ADI quintiles, patients were more likely to present with symptomatic disease (Q5, 52.1% vs Q1, 46.6%; P < .001), and stroke vs transient ischemic attack (Q5, 63.1% vs Q1, 53.5%; P < .001); they also more frequently underwent CAS vs CEA (Q5, 46.4% vs Q1, 33.9%; P < .001), and specifically tfCAS vs TCAR (Q5, 54.2% vs Q1, 33.9%; P < .001). In adjusted analyses, higher ADI quintiles remained as independent risk factors for presenting with symptomatic disease and stroke and undergoing CAS and tfCAS. Across ADI quintiles, patients were more likely to experience death (Q5, 0.8% vs Q1, 0.4%; P < .001), stroke/death (Q5, 2.1% vs Q1, 1.6%; P = .001), failure to discharge home (Q5, 11.5% vs Q1, 8.0%; P < .001) and length of stay >2 days (Q5, 33.3% vs Q1, 26.3%; P < .001) following revascularization. CONCLUSIONS: Among carotid revascularization patients, those with greater neighborhood social disadvantage had greater disease severity and more frequently underwent tfCAS. These patients also had higher rates of death and stroke/death, were less frequently discharged home, and had prolonged hospital stays. Greater efforts are needed to ensure that patients in higher ADI quintiles undergo better carotid surveillance and are treated appropriately for their carotid artery disease.

Trends in mortality and postoperative complications among octogenarian patients undergoing carotid endarterectomy.

BACKGROUND: Elderly patients represent a large portion of patients undergoing vascular surgery. This study aims to assess the contemporary frequency of octogenarians undergoing carotid endarterectomy (CEA) and to evaluate their postoperative complications and survival rates. METHODS: The Vascular Quality Initiative (VQI) dataset was queried for patients who underwent elective CEA between 2012 and 2021. Patients aged >90 years were excluded, as well as emergent and combined cases. The population was divided into two age groups: <80 years and ≥80 years. Frailty scores were generated using Vascular Quality Initiative variables grouped into 11 domains historically associated with frailty. Patients with scores within the first 25th percentile, between the 25th and 50th percentile, and above the 75th percentile were categorized into low, medium, and high frailty classes, respectively. Procedural indications were defined as hard (stenosis ≥80% or ipsilateral neurologic symptoms) or soft. Primary outcomes of interest were 2-year stroke-free and 2-year overall survival comparing (i) octogenarians with nonoctogenarians and (ii) octogenarians by frailty class. Standard statistical methods were used. RESULTS: Overall, 83,745 cases were included in this analysis. Between 2012 and 2021, a consistent proportion averaging 17% of CEA patients were octogenarians. Among this age group, the proportion of patients undergoing CEA for hard indications increased over time from 43.7% to 63.8% (P < .001). This increase was accompanied by a statistically significant increase in the combined 30-day perioperative stroke and mortality rate from 1.56% in 2012 to 2.96% in 2021 (P = .019). A Kaplan-Meier analysis showed a significantly lower 2-year stroke-free survival among octogenarians compared with the younger group (78.1% vs 87.6%; P < .001). Similarly, there was a significantly lower 2-year overall survival among octogenarians compared with the younger group (90.5% vs 95.1%; P < .001). Multivariate Cox proportional hazard analyses showed that high frailty class was associated with increased 2-year stroke risk (hazard ratio, 2.26; 95% confidence interval, 1.61-3.17; P < .001) and 2-year mortality (hazard ratio, 2.43; 95% confidence interval, 1.71-3.47; P < .001). Repeat Kaplan-Meier analysis stratifying octogenarians by frailty class revealed that octogenarians with low frailty can have stroke-free and overall survival rates comparable with nonoctogenarians (88.2% vs 87.6% [P = .158] and 96.0% vs 95.1% [P = .151], respectively). CONCLUSIONS: Chronological age should not be regarded as a contraindication for CEA. Frailty score calculation is a better predictor for postoperative outcomes and is an appropriate tool to risk stratify octogenarians, aiding in the decision between best medical treatment or intervention. The risk benefit assessment for high frailty class octogenarians is paramount because the postoperative risks may outweigh the long-term survival benefits of the prophylactic CEA.

Propensity-score-matched analysis of dual antiplatelet treatment and alternative antiplatelet regimens after transcarotid revascularizations.

OBJECTIVE: Dual antiplatelet therapy (DAPT) continues to be the preferred medication regimen after the placement of a carotid stent using the transcarotid revascularization (TCAR) technique despite a dearth of quality data. Therefore, this investigation was performed to define the risks associated with antiplatelet choice. METHODS: We queried all patients who underwent TCAR captured by the Vascular Quality Initiative from September 2016 to June 2022, to determine the association between antiplatelet choice and outcomes. Patients maintained on DAPT were compared with those receiving alternative regimens consisting of single antiplatelet, anticoagulation, or a combination of the two. A 1:1 propensity-score match was performed with respect to baseline comorbidities, functional status, anatomic/physiologic risk, medications, and intraoperative characteristics. In-hospital and 1-year outcomes were compared between the groups. RESULTS: During the study period, 29,802 procedures were included in our study population, with 24,651 (82.7%) receiving DAPT and 5151 (17.3%) receiving an alternative antiplatelet regimen. A propensity-score match with respect to 29 variables generated 4876 unique pairs. Compared with patients on DAPT, in-hospital ipsilateral stroke was significantly higher in patients receiving alternative antiplatelet regimens (1.7% vs 1.1%, odds ratio [95% confidence interval]: 1.54 [1.10-2.16], P = .01), whereas no statistically significant difference was noted with respect to mortality (0.6% vs 0.5%, 1.35 [0.72-2.54], P = .35). A composite of stroke/death was also more likely in patients receiving an alternative regimen (2.4% vs 1.7%, 1.47 [1.12-1.93], P = .01). Immediate stent thrombosis (2.75 [1.16-6.51]) and a nonsignificant trend toward increased return to the operating room were more common in the alternative patients. Conversely, the incidence of perioperative myocardial infarction was lower in the alternative regimen group (0.4% vs 0.7%, 0.53 [0.31-0.90], P = .02). At 1 year after the procedure, we observed an increased risk of mortality (hazard ratio [95% confidence interval]: 1.34 [1.11-1.63], P < .01) but not stroke (0.52 [0.27-0.99], P = .06) in patients treated with an alternative medication regimen. CONCLUSIONS: This propensity-score-matched analysis demonstrates an increased risk of in-hospital stroke and 1-year mortality after TCAR in patients treated with an alternative medication regimen instead of DAPT. Further studies are needed to elucidate the drivers of DAPT failure in patients undergoing TCAR to improve outcomes for carotid stenting patients.

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

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

Predictors of 30-Day Stroke and Death After Transcarotid Revascularization.

INTRODUCTION: Much of the previous robust analyses of the results associated with transcarotid revascularization (TCAR) derives from industry-sponsored trials or the Vascular Quality Initiative (VQI). This investigation was performed to identify preoperative predictors of 30-day stroke and death using institutional databases. METHODS: A retrospective analysis was performed of carotid revascularization databases created at two high-volume TCAR centers and maintained independently of the VQI carotid module between December 2015 and December 2021. The primary outcome of interest was a composite of perioperative (30-day) stroke and death. Univariate regression analyses, followed by multivariate regression analyses, were performed to identify potential predictors of adverse events. RESULTS: During the study period, 750 TCAR procedures were performed at our combined health systems, resulting in 24 (3.2%) individuals who experienced either stroke and/or death in the perioperative period. Of these, we observed nine (1.2%) mortality events and 18 (2.4%) strokes. On univariate analysis, candidate protectors of stroke/death were found to be coronary artery disease (odds ratio [OR], 0.43; 95% confidence interval [CI], 0.18-1.01; P = 0.05) and protamine reversal (0.51; 0.21-1.21; P = 0.15). Candidate predictors of the primary outcome were anticoagulant usage (3.03; 1.26-7.24; P = 0.01), postprocedural debris in the filter (2.30; 0.97-5.43; P = 0.06), symptomatic carotid lesion (2.03; 0.90-4.50), and cardiac arrhythmia (1.98; 0.80-4.03; P = 0.14). On multivariate analysis, two predictors remained, cardiac arrhythmia (4.21; 1.10-16.16; P = 0.04) and symptomatic carotid lesion (14.49; 1.80-116.94; P = 0.01). CONCLUSIONS: A symptomatic carotid lesion, and to a lesser extent cardiac arrhythmia, are strong predictors of 30-day stroke/death after TCAR. Surgeons should be cognizant of the increased risk of adverse events in the perioperative period in these patients.

Transcarotid revascularization in obese patients.

OBJECTIVE: Transcarotid revascularization (TCAR) is a minimally invasive hybrid surgical carotid stenting technique which utilizes cerebral flow reversal as embolic protection during carotid lesion manipulation. This investigation was performed to define the perioperative risks associated with this operation in the obese patient. METHODS: A retrospective review of tandem carotid revascularization databases maintained at two high-volume health systems was performed to capture all TCARs performed between 2015 and 2022. A threshold of body mass index of 35 kg/m2 defined the "obese" patient. Demographics, intraoperative, perioperative, and follow-up characteristics were compared using univariate analysis. RESULTS: We performed 793 TCAR procedures that qualified for study inclusion within the prespecified time. After applying our obesity definition, 129 patients qualified as obese and were compared to the remainder. There were no significant differences in baseline demographics as comparable Charlson Comorbidity Indices were noted between groups; however, obese patients had a significantly higher prevalence of hypertension, hyperlipidemia, and diabetes. Intraoperative, case complexity in the obese patients did not seem to be increased, as measured by operative time (68.4 ± 23.0 vs 64.2 ± 25.8 min, p = 0.09), fluoroscopic time (4.9 ± 3.2 vs 4.6 ± 3.6 min, p = 0.38), and estimated blood loss (40.6 ± 49.0 vs 46.6 ± 49.4 min, p = 0.22). Similarly, no disparities were observed with respect to ipsilateral stroke (3.1 vs. 1.7%, p = 0.29), contralateral stroke (0 vs. 0.2%, p > 0.99), death (0 vs. 1.1%, p = 0.61), and stroke/death (3.1 vs. 3.0%, p > 0.99) in the 30-day perioperative period. Both cohorts were followed for approximately 1 year (12.0 ± 13.4 vs 11.6 ± 13.4 months, p = 0.76). During this period, rates of ipsilateral stroke (3.1% vs. 2.7%, p > 0.99), contralateral stroke (1.1 vs. 0.8%, p > 0.99), and death (4.7 vs. 6.2%, p = 0.68) were similar. CONCLUSIONS: TCAR performed in the obese population was not more challenging by intraoperative characteristics and did not result in a statistically higher incidence of adverse events in the perioperative phase.

Subclavian to carotid artery bypass for a case of ocular ischemic syndrome.

BACKGROUND: Ocular Ischemic Syndrome (OIS) is a rare, vision threatening condition associated with severe carotid artery disease. There are few cases of OIS reported in the literature. METHODS: We present the case of a 54-year-old male with history of multiple previous carotid interventions including a right carotid stent, who presented with right-sided OIS. RESULTS: CTA and angiogram showed a severe calcific plaque causing restenosis of the right carotid stent, with a patent right internal carotid artery (ICA) in the very distal neck. The right common carotid artery (CCA) was patent but diseased with ulcerated plaque extending proximally to below the level of the clavicle. The left CCA was chronically occluded from its origin all the way to the bifurcation. Given our patient's surgical history, the imperative to revascularize the ipsilateral carotid, and a diffusely diseased ipsilateral CCA, he was successfully treated with an ipsilateral subclavian to internal carotid bypass. CONCLUSION: There is paucity of data regarding the best approach for carotid revascularization in OIS. This case report discusses our unique perioperative decision making as well as relevant literature.

Prediction of postprocedural filter debris after transcarotid revascularization.

OBJECTIVE: Transcarotid revascularization (TCAR) is a technique in which cerebral flow reversal is utilized as embolic protection during carotid stenting. The presence, or absence, of filter debris created during TCAR could potentially be a surrogate to characterize carotid lesions at high risk for embolization and, therefore, explored in this investigation. METHODS: A retrospective review of TCARs performed within the Indiana University and Memorial Hermann (McGovern Medical School at UTHealth) Health Systems to capture demographics and preoperative variables. A mixed effect multivariate logistic regression model was created to discern the best predictors of intraoperative filter debris. RESULTS: During the study period, from December 2015 to December 2021, we captured filter debris status in 693 of 750 patients containing 323 cases of filter embolization at case completion. With respect to demographics and indications, we found a higher incidence of neck radiation (2.7 vs. 7.1%, p = 0.01) and a more pronounced Charlson Comorbidity Index (CCI; 5.3 ± 0.3 vs 5.7 ± 0.3, p < 0.01) in the filter debris cohort while contralateral carotid occlusion (6.6 vs. 2.9%, p = 0.05) and clopidogrel usage (87.3 vs. 80.1%, p = 0.03) were less common. Longer intraoperative flow reversal (8.0 ± 1.2 vs 10.5 ± 1.2, p < 0.01) and fluoroscopy time (4.0 ± 0.6 vs 5.1 ± 0.6, p < 0.01) were also seen in those with filter debris. These findings remained when a mixed effect univariate logistic regression model was used to account for differences in filter debris reporting between locations. After multivariable modeling, we found that reverse flow time and CCI remained predictive of filter debris while the presence of a contralateral carotid occlusion was still protective. CONCLUSION: In our combined experience, the creation of visible filter debris after TCAR seems to be independently associated with extended reverse flow time and elevated CCI while a contralateral carotid occlusion was protective.

Bypass and other modified reconstruction techniques for 'challenging' carotid cases: A comparison with conventional endarterectomy.

OBJECTIVE: Standard carotid endarterectomy (CEA) is usually performed with patch closure or eversion. However, sometimes a 'modified' carotid artery revascularization (MCAR) technique is required if the lesion is complex, extended and anatomically or technically challenging. MCAR is defined as carotid artery bypass; otherwise, it is the combination of common carotid artery (CCA) primary suture or patch angioplasty, associated with internal carotid artery (ICA) patch closure or eversion. The aim of this study was to evaluate the outcomes of MCAR during complex carotid procedures, comparing them with standard CEA. METHODS: A retrospective analysis of asymptomatic patients who underwent CEA during a 16-year period (June 2005 to June 2021) was performed. Patients were divided into three different groups: ECEA (eversion CEA), PCEA (CEA with patch angioplasty) and MCAR. Primary endpoints were relevant neurological complication rate (RNCR), death within 30 days, freedom from ipsilateral stroke, reintervention rates and freedom from carotid artery restenosis. RESULTS: A total of 1,752 patients were included (ECEA: 699; PCEA: 948; MCAR: 105) in the study. Patients treated with MCAR were significantly older and had a higher SVS score for arterial hypertension compared with ECEA and PCEA groups. A long plaque in the CCA was the most common indication for MCAR (40.1%); inadequate distal plaque-end or distal dissection (25.7%) was the second most prevalent indication. Overall perioperative RNCR, defined as minor and major stroke, was 0.7% (ECEA: 0.4%; PCEA: 0.7%; MCAR: 1.9%; p = 0.22), without any significant difference among the three groups. However, patients treated with MCAR had a significantly higher rate of global central neurological complications (defined as transient ischaemic attack, minor stroke and major stroke) than the other cohorts (ECEA: 0.7%; PCEA: 1.2%; MCAR: 3.8%; p = 0.02). One patient (0.05%) died perioperatively of a major cerebral infarction. Long-term follow-up (66.7 ± 43.9) showed a significantly lower rate of freedom from ipsilateral stroke for the MCAR group (96.8%) compared with ECEA and PCEA groups (99.8% and 98.9%, respectively, p = 0.03). Similar reintervention rates (ECEA: 2.7%; PCEA: 3.3%; MCAR: 3.8%; p = 0.74) and freedom from carotid restenosis rates (ECEA: 1.3%; PCEA: 2.6%; MCAR: 1.9%; p = 0.16) were observed. CONCLUSIONS: Patients who underwent ICA revascularization with MCAR showed risks of perioperative death, major or minor stroke (<2%), reintervention rates and carotid restenosis rates that are comparable with PCEA or ECEA groups. Nevertheless, the MCAR group showed a significantly higher rate of global central neurological complications (considering together TIA, minor stroke and major stroke) than patients treated with standard CEA. MCAR techniques appear to be effective alternatives to standard CEAs, with an acceptable surgical risk. However, these should be performed mainly in selected cases, for example, in complex anatomy (detected in a non-negligible percentage of patients by preoperative imaging), or in the case of unexpected intraoperative technical issues.

The Impact of age and outcomes of high-risk patients on carotid revascularization.

OBJECTIVES: To validate the accuracy of high-risk criteria for carotid endarterectomy (CEA) and analyze the correlation between age and outcome of CEA and carotid artery stenting (CAS) in risk groups. METHODS: We reviewed a prospectively managed vascular surgery database in a single tertiary referral center, and 2482 internal carotid arteries (ICAs) had undergone carotid revascularization from November 1994 to December 2021. To validate high-risk criteria for CEA, patients were classified as high risk (Hr) and normal risk (Nr). Subgroup analysis was performed with patients older or younger than 75 years to investigate the relationship between age and outcome in each group. Primary endpoints were 30-day outcomes including stroke, death, stroke/death, myocardial infraction (MI), and major adverse cardiovascular events (MACEs). RESULTS: A total of 2345 ICAs in 2256 patients were enrolled. The number of patients in the Hr group was 543 (24%) and the number in the Nr group was 1713 (76%). CEA and CAS were performed on 1384 (61%) and 872 (39%) patients, respectively. The 30-day stroke/death rate was higher with CAS than CEA in both the Hr (1.1% vs. 3.9%, p = 0.032) and Nr (1.2% vs. 6.9%, p < 0.001) groups. In unmatched logistic regression analysis of the Nr group (n = 1778), the rate of 30-day stroke/death (OR, 5.575; 95% CI, 2.922-10.636; p < 0.001) was higher for CAS than CEA. In propensity score matching of the Nr group, the rate of 30-day stroke/death (OR, 5.165; 95% CI, 2.391-11.155; p < 0.001) was also higher for CAS than CEA. In the age <75 subgroup of the Hr group (n = 428), CAS was associated with higher 30-day stroke/death (OR, 14.089; 95% CI, 1.314-151.036; p = 0.029). In the age ≥75 subgroup of the Hr (n = 139), there was no difference in 30-day stroke/death between CEA and CAS. In the age <75 subgroup of the Nr group (n = 1318), 30-day stroke/death (OR, 6.300; 95% CI, 2.797-14.193; p < 0.001) was higher in CAS. In the age ≥75 subgroup of the Nr group (n = 460), 30-day stroke/death (OR, 6.468; 95% CI, 1.862-22.471; p = 0.003) was higher in CAS. CONCLUSIONS: In patients older than 75 years in the Hr group, there were relatively poor 30-day treatment outcomes in both CEA and CAS. Alternative treatment is needed that can expect better outcomes in older high-risk patients. In the Nr group, CEA has a significant benefit compared with CAS, and CEA should be recommended more to these patients.

Results associated with the health system-wide adoption of transcarotid revascularization.

BACKGROUND: In the present report, we have detailed the results derived from the adoption of transcarotid artery revascularization (TCAR) at a large health system based in the United States. METHODS: A retrospective review was performed of a prospectively maintained database capturing all carotid stents deployed using the ENROUTE neuroprotection device (Silk Road Medical, Sunnyvale, CA) and cerebral flow reversal. The demographics, intraoperative findings, and postoperative results were tabulated and reported. RESULTS: From September 2017 to December 2021, 429 TCAR procedures were attempted within the Memorial Hermann Health System. Preoperatively, all the patients were either asymptomatic with >70% stenosis (66.9%) or symptomatic with >50% stenosis (33.1%). The degree of stenosis was determined using computed tomography angiography and/or duplex ultrasound. We achieved a technical success rate of 99.1%, with the failures attributed to an inability to cross the lesion, an inability to track the stent, visualization of a flow-limiting dissection, and stent maldeployment for one patient each. During the 30-day perioperative period, nine strokes (2.3%) had occurred, three of which had occurred after discharge from the index operation and before the end of the 30-day period. No patient had experienced myocardial infarction. Five patients had died in the perioperative period. Three of the deaths were related to stroke, and two were attributed to cardiopulmonary events secondary to aspiration and likely pulmonary embolus. The mean follow-up after TCAR was 14.5 ± 12.0 months. During the follow-up period, two patients had required reintervention for in-stent stenosis. Ipsilateral to the implanted carotid stent, the overall (including perioperative) stroke incidence was 2.5%. Contralateral to the stent, the stroke incidence was 0.8%. The myocardial infarction rate was 0.8% during follow-up. Mortality in our study population was 5.1% during the follow-up period. CONCLUSIONS: After adoption of TCAR across the Memorial Hermann Health System, we found this procedure to be safe and efficacious with minimal perioperative risks comparable to the historically reported results associated with alternative carotid interventions.

Transcarotid artery revascularization is safe in necks with anatomy hostile for carotid endarterectomy.

OBJECTIVE: The outcomes associated with transcarotid revascularization (TCAR) have proved to be noninferior to the historical results established for carotid endarterectomy (CEA). Therefore, TCAR has been increasingly offered to patients with neck anatomy hostile for traditional CEA. The present investigation was completed to evaluate whether a difference exists for patients undergoing TCAR in de novo anatomy with unviolated surgical planes compared with those undergoing TCAR in necks with hostile anatomy. METHODS: The demographic data and outcomes were captured at two high-volume TCAR institutions from December 2015 to December 2021 via a query of two parallel, prospectively maintained, carotid intervention databases at these two health institutions. A hostile neck anatomy was defined as a history of previous ipsilateral neck radiation, oncologic dissection, or CEA. Univariate analysis was performed to compare the two cohorts at an α of 0.05. RESULTS: During the inclusion period, the data from 750 TCARs were captured, including 108 procedures in hostile neck anatomy and 642 in de novo necks. No significant differences were found in the baseline comorbidity burden using the Charlson comorbidity index or the indication for revascularization. Intraoperatively, no significant increase in case complexity was observed with respect to those with a hostile neck, except for the operative time, which was 10% longer (69.5 vs 63.4 minutes; P = .01). The flow reversal and fluoroscopic times, blood loss, radiation exposure, and contrast use were identical. Postoperatively, no differences were observed between the hostile and de novo necks with respect to stroke (0.9% vs 2.5%; P = .49), myocardial infarction (0.9% vs 0.2%; P = .27), and death (0% vs 1.5%; P = .37). Additionally, hematoma formation and the need for reintervention did not seem to vary between the two groups. Similarly, no differences in the two cohorts were noted during follow-up. CONCLUSIONS: According to the findings from our large, dual-institutional series, the performance of TCAR in surgical fields traditionally hostile for CEA was not associated with increased intraoperative complexity or postoperative morbidity.