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 3 procedures. Age, female sex, nonwhite 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 3 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 3 procedures; CEA (HR,1.64; 95%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<0.05). 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 are risk for pLOS highlight quality improvement strategies that can optimize short and 1-year outcomes of patients undergoing carotid revascularization.

Outcomes of Transcarotid Artery Revascularization Stratified by Institutional Designation: Academic Versus Community Hospitals.

BACKGROUND: The extent of practice setting's influence on transcarotid artery revascularization (TCAR) outcomes is not yet established. This study seeks to assess and compare TCAR outcomes in academic and community-based healthcare settings. METHODS: Retrospective review of prospectively maintained, systemwide TCAR databases from 2 institutions was performed between 2015 and 2022. Patients were stratified based on the setting of surgical intervention (i.e., academic or community-based hospitals). Relevant demographics, medical conditions, anatomic characteristics, intraoperative and postoperative courses, and adverse events were captured for multivariate analysis. RESULTS: We identified 973 patients who underwent TCAR, 570 (58.6%) were performed at academic and 403 (41.4%) at community-based hospitals. An academic facility was defined as a designated teaching hospital with 24/7 service-line coverage by a trainee-led surgical team. Baseline comorbidity between cohorts were similar but cases performed at academic institutions were associated with increased complexity, defined by high cervical stenosis (P < 0.001), prior dissection (P < 0.01), and prior neck radiation (P < 0.001). Intraoperatively, academic hospitals were associated with longer operative time (67 min vs. 58 min, P < 0.001), higher blood loss (55 mLs vs. 37 mLs, P < 0.001), and longer flow reversal time (9.5 min vs. 8.4 min, P < 0.05). Technical success rate was not statistically different. In the 30-day perioperative period, we observed no significant difference with respect to reintervention (1.5% vs. 1.5%, P ≥ 0.9) or ipsilateral stroke (2.7% vs. 2.0%, P = 0.51). Additionally, no difference in postoperative myocardial infarction (academic 0.7% vs. community 0.2%, P < 0.32), death (academic 1.9% vs. community 1.4%, P < 0.57), or length of stay (1 day vs. 1 day, P < 0.62) was seen between the cohorts. CONCLUSIONS: Cases performed at academic centers were characterized by more challenging anatomy, more frequent cardiovascular risk factors, and less efficient intraoperative variables, potentially attributable to case complexity and trainee involvement. However, there were no differences in perioperative outcomes and adverse events between the cohorts, suggesting TCAR can be safely performed regardless of practice setting.

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.

Hemodynamic instability predicts in-hospital and 1-year mortality after transcarotid artery revascularization and transfemoral carotid stenting.

OBJECTIVE: Blood pressure fluctuations are a common hemodynamic alteration following carotid artery stenting either with transfemoral (TFCAS) or transcarotid (TCAR) approach and are thought to be related to alteration in baroreceptor function due to angioplasty and stent expansion. These fluctuations are particularly worrisome in the high-risk patient population referred for CAS. This study aims to evaluate the outcomes of patients who required the administration of intravenous blood pressure medication (IVBPmed) for hypotension or hypertension after CAS. METHODS: All patients undergoing carotid revascularization in the Vascular Quality Initiative (VQI) database between 2016 and 2021 were included. We compared outcomes of patients who required postoperative IVBPmed to treat hyper- or hypotension with normotensive patients. In-hospital outcomes were compared using multivariable logistic regression. One-year outcomes were assessed using Kaplan-Meier survival and multivariable Cox proportional hazard regression analyses. RESULTS: We identified 38,510 patients undergoing CAS (57.7% TCAR and 42.3% TFCAS), of which, 30% received IVBPmed for treatment of either postoperative hypertension (12.6%) or hypotension (16.4%). In multivariable analysis, postoperative hypotension was associated with a higher risk of stroke, death, or myocardial infarction (MI) (odds ratio [OR], 3.1; 95% confidence interval [CI], 2.6-3.6; P < .001), stroke or death (OR, 2.9; 95% CI, 2.4-3.5; P < .001), stroke (OR, 2.6; 95% CI, 2.1-3.2; P < .001), death (OR, 3.5; 95% CI, 2.6-4.8; P < .001), MI (OR, 4.7; 95% CI, 3.3-6.7; P < .001), and bleeding (OR, 1.96; 95% CI, 1.4-2.7; P < .001) compared with normotensive patients. Postoperative hypertension was associated with a higher risk of stroke, death, or MI (OR, 3.6; 95% CI, 3-4.4; P < .001), stroke or death (OR, 3.3; 95% CI, 2.7-4.1; P < .001), stroke (OR, 3.7; 95% CI, 3-4.7; P < .001), death (OR, 2.7; 95% CI, 1.9-3.9; P < .001), MI (OR, 5.7; 95% CI, 3.9-8.3; P < .001), and bleeding (OR, 1.9; 95% CI, 1.4-2.7; P < .001) compared with normotensive patients. CONCLUSIONS: Postoperative hypertension or hypotension requiring IVBPmed after CAS is associated with an increased risk of in-hospital stroke, death, MI, and bleeding. Postoperative hypertension is associated with worse survival at 1 year. This study indicates that the need for IVBPmed after CAS is not benign; therefore, these patients necessitate aggressive perioperative medical management and safe techniques to avoid hypo and hypertension. Close follow-up and continue medical management are needed to maximize these patients' survival.

Risk of Stroke, Death, and Myocardial Infarction Following Transcarotid Artery Revascularization vs Carotid Endarterectomy in Patients With Standard Surgical Risk.

Importance: Carotid artery stenting has been limited to use in patients with high surgical risk; outcomes in patients with standard surgical risk are not well known. Objective: To compare stroke, death, and myocardial infarction outcomes following transcarotid artery revascularization vs carotid endarterectomy in patients with standard surgical risk. Design, Setting, and Participants: This retrospective propensity-matched cohort study was conducted from August 2016 to August 2019 with follow-up until August 31, 2020, using data from the multicenter Vascular Quality Initiative Carotid Artery Stent and Carotid Endarterectomy registries. Patients with standard surgical risk, defined as those lacking Medicare-defined high medical or surgical risk characteristics and undergoing transcarotid artery revascularization (n = 2962) or carotid endarterectomy (n = 35 063) for atherosclerotic carotid disease. In total, 760 patients were excluded for treatment of multiple lesions or in conjunction with other procedures. Exposures: Transcarotid artery revascularization vs carotid endarterectomy. Main Outcomes and Measures: The primary outcome was a composite end point of 30-day stroke, death, or myocardial infarction or 1-year ipsilateral stroke. Results: After 1:3 matching, 2962 patients undergoing transcarotid artery revascularization (mean [SD] age, 70.4 [6.9] years; 1910 [64.5%] male) and 8886 undergoing endarterectomy (mean [SD] age, 70.0 [6.5] years; 5777 [65.0%] male) were identified. There was no statistically significant difference in the risk of the primary composite end point between the 2 cohorts (transcarotid 3.0% vs endarterectomy 2.6%; absolute difference, 0.40% [95% CI, -0.43% to 1.24%]; relative risk [RR], 1.14 [95% CI, 0.87 to 1.50]; P = .34). Transcarotid artery revascularization was associated with a higher risk of 1-year ipsilateral stroke (1.6% vs 1.1%; absolute difference, 0.52% [95% CI, 0.03 to 1.08]; RR, 1.49 [95% CI, 1.05 to 2.11%]; P = .02) but no difference in 1-year all-cause mortality (2.6% vs 2.5%; absolute difference, -0.13% [95% CI, -0.18% to 0.33%]; RR, 1.04 [95% CI, 0.78 to 1.39]; P = .67). Conclusions and Relevance: In this study, the risk of 30-day stroke, death, or myocardial infarction or 1-year ipsilateral stroke was similar in patients undergoing transcarotid artery revascularization compared with those undergoing endarterectomy for carotid stenosis.

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.

Transcarotid Revascularization Timing and Early Postoperative Outcomes in Symptomatic Patients.

OBJECTIVE: Carotid endarterectomy (CEA) performed several days after onset of symptoms has been shown to be optimal in preventing procedure-related stroke. Transcarotid artery revascularization (TCAR) is an alternative hybrid procedure to treat high-risk for CEA patients. In this investigation, our aim is to determine the effect of timing of TCAR in symptomatic patients. METHODS: Procedures were captured prospectively at 2 independent health systems from 2016-2022 within a carotid intervention database. A retrospective analysis of this database was performed to generate cohorts by time to revascularization from onset of symptoms, with the short-interval revascularization (SIR) group defined as having a time to revascularization between 2-5 days; and long-interval revascularization (LIR) group having a time to revascularization of 6-180 days. Univariate analysis was performed comparing the cohorts at an α of .05. RESULTS: During the study period, 875 TCARs were captured, including 321 procedures performed in symptomatic patients. Of these, 84 had revascularization performed within 6 days after onset of symptoms (SIR) while 237 additional cases were completed 6 or more days after onset of symptoms (LIR). Baseline comorbidities were grossly similar between cohorts. Intraoperatively, SIR patients were less likely to develop bradycardia (4.8% vs 22.2%, P = .01) and experienced a shorter operative time (58 minutes vs 65 minutes, P = .02). Estimated blood loss, flow reversal time, radiation exposure, fluoroscopic time and contrast volume were identical between the groups. Length of stay in SIR patients was longer (1, IQR [1-3] vs 1, IQR [1-2] days, P < .01). Additionally, SIR patients seemed to trend toward a higher rate of reinterventions (3.6% vs .4%, P = .06). The incidence of ipsilateral or contralateral stroke, cranial nerve palsy, myocardial infarction, hematoma, stent thrombosis and death were statistically identical between the 2 groups. CONCLUSION: Like the previous results established for CEA, symptomatic patients undergoing TCAR demonstrate similar outcomes if the procedure is performed 48 hours after the neurologic event.

Fate of Hemodialysis Patients Undergoing Transcarotid Revascularization.

INTRODUCTION: Carotid revascularization in patients with end-stage renal disease (ESRD) continues to be a controversial topic, as life expectancy is poor, thus, preventing the recouperation of cumulative stroke-risk reduction in the postoperative period. We performed this primarily descriptive analysis of the results of transcarotid revascularization (TCAR) in renal failure patients. METHODS: A retrospective review of two independent carotid revascularization databases maintained at two large health systems were performed to capture all consecutive TCAR procedures. Patients were classified as either (1) ESRD or (2) preserved renal function (PRF) and compared with standard univariate techniques, where appropriate. RESULTS: From December 2015 to April 2022, 851 consecutive TCARs were attempted at our participating facilities. Of these, 27 were performed in ESRD patients (all hemodialysis). These patients were younger and presented with a higher Charlson Comorbidity Index. The incidence of a high anatomic risk criterion as defined for the Centers for Medicare and Medicaid Services (CMS) were similar between groups, as was the incidence of a symptomatic carotid lesion. There were no differences between the groups in terms of intraoperative characteristics and the postoperative medication management were grossly similar by renal function. In the 30-day perioperative period, there were no stroke, death, or myocardial infarction in the 27 ESRD patients treated with TCAR. The mean duration of follow-up in the ESRD cohort was 15.0 months. During this time, there was no ipsilateral stroke events, one contralateral stroke, and one MI. All 27 carotid stents remained patent during this period. Six patients perished after TCAR at a mean interval of 12.2 months after TCAR. CONCLUSION: Survival is poor after carotid revascularization via the TCAR technique on intermediate follow-up. Careful patient selection is required to identify those who will survive to collect on the cumulative stroke-risk reduction afforded by carotid intervention.

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.

Dual Antiplatelet Alternatives are Associated With Increased Stroke and Death After Transcarotid Revascularization.

OBJECTIVE: To define the risks associated with the replacement of dual antiplatelets for alternate medication regimens. BACKGROUND: Patients undergoing transcarotid artery revascularization (TCAR) for atherosclerotic disease in the Vascular Quality Initiative database from September 2016 to June 2022 were included. In all, 29,802 TCAR procedures were captured between 2016 and 2022, consisting of 24,651 (82.7%) maintained on dual antiplatelet therapy (DAPT) and 5151 (17.3%) on alternative regimens. METHODS: Patients maintained on DAPT were compared with those on alternative regimens consisting of any combination of single antiplatelet monotherapy and/or anticoagulation. RESULTS: On univariable analysis, patients on alternative medications were more likely to experience in-hospital death, ipsilateral stroke, any stroke, and transient ischemic attacks compared with patients in the DAPT group. The mortality rate was higher at 1 year in the alternative cohort (4.7% vs 7.0%, P <0.01). The use of alternate medication regimens was associated with increased odds of stroke and the composite outcome of in-hospital stroke/death compared with DAPT. There was also a significant association between alternative medication use and increased odds of in-hospital transient ischemic attack, immediate stent occlusion, and return to the operating room. At 1 year, there was no significant difference in the incidence of stroke between the 2 groups. However, the use of alternate regimens was associated with higher 1-year of mortality after multivariable adjustment. CONCLUSIONS: Patients not maintained on DAPT after TCAR experienced an increased risk of stroke and death in the perioperative and follow-up periods. Increased surgeon vigilance is required to ensure compliance with dual antiplatelets as recommended.

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

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

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.

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.

Dual Institutional Experience with Transcarotid Artery Revascularization.

INTRODUCTION: Transcarotid artery revascularization (TCAR) is a hybrid open and endovascular technique to treat carotid stenosis. The purpose of this study is to present a large cohort of patients who underwent TCAR at 2 high-volume TCAR health systems. METHODS: This study was a retrospective chart review of all instances of TCAR within the Memorial Hermann Health System and Indiana University Health, from December 2015-January 2022, using the ENROUTE Neuroprotection Device (Silk Road Medical, Sunnyvale, CA). We report patient demographics, intraoperative metrics, 30-day results and long-term results. RESULTS: In all, 750 patients underwent TCAR in the designated time period. Average patient age was 73 years, with 68% being male. Overall, 53.9% of patients had coronary artery disease, 45.4% had diabetes, and 36.9% were symptomatic. Technical success was achieved in 98.8% of patients with conversion to open endarterectomy in 1.1%. Average reverse flow time was 9.1 minutes with length of stay greater than 1 day 38%. Ipsilateral stroke rate within 30 days was 2.3% and long-term cumulative stroke rate was 3.0%. Death within 30 days occurred in 1.2% of patients and in 5.9% over long-term follow up. In all, 1% of patients required reintervention. CONCLUSIONS: TCAR is a safe and effective treatment modality for carotid artery stenotic disease. Its outcomes are similar to historical results associated with carotid endarterectomy, long considered the gold standard.

An Analysis of Sex-Based Outcomes Following Transcarotid Artery Revascularization.

OBJECTIVE: Several studies suggest that females have higher perioperative adverse events and decreased benefit from carotid artery revascularization with transfemoral carotid artery stenting and carotid endarterectomy (CEA) compared to males. However, there are limited data of sex-based outcomes for transcarotid artery revascularization (TCAR). METHODS: A retrospective review of prospectively maintained system-wide TCAR databases was performed between December 2015-January 2022. Patients who underwent TCAR were stratified based on sex. Relevant demographics, medical conditions, anatomical characteristics, intra- and postoperative courses, and adverse events were captured. RESULTS: 729 patients underwent TCAR, 486 (66.6%) male and 243 (33.3%) female. Males were more likely to be diagnosed with coronary artery disease (56.9% vs 47.7%, P<.01) and were active smokers (30.4% vs 21.4%, P < .01). Age, symptomatic status, BMI, hypertension, hyperlipidemia, diabetes mellitus, arrhythmia, chronic obstructive pulmonary disease, history of myocardial infarction, heart failure with reduced ejection fraction <30%, end-stage renal disease and Charlson Comorbidity Index were similar. In the perioperative period, there was no significant difference in reintervention rates (1.6% vs 1.2%, P = .75), cranial nerve palsy (.6% vs .4%, P > .99), ipsilateral stroke (1.9% vs 3.3%, P = .29), stent thrombosis (.4% vs .8%, P > .99), myocardial infarction (0% vs 0%, P > .99) and death (1.2% vs 1.2%, P > .99). In follow-up, no significant difference was found in reintervention, ipsilateral stroke, contralateral stroke, myocardial infarction, in-stent restenosis >50%, stent thrombosis, and death. CONCLUSIONS: Males and females did not have a statistically significant difference in outcomes when comparing ipsilateral stroke, in-stent thrombosis, conversion to CEA, and death after TCAR. However, our cohort comprised predominantly male patients and may conceal statistical significance as the females in our cohort did have a higher tendency toward developing complications. Future studies with a larger female cohort should be conducted to determine whether there is a true disparity of outcomes between the males and females undergoing TCAR.

Transcarotid Revascularization Results in Patients Over 70 Years of Age.

OBJECTIVE: Carotid endarterectomy is associated with fewer procedure-related strokes than transfemoral carotid artery stenting in older populations, based on the results from previous quality randomized controlled studies. Transcarotid artery revascularization (TCAR) is a hybrid procedure completed in the setting of cerebral flow reversal to deploy a stent, making it an appealing choice for older patients. This study was completed to elicit any age-related differences in outcomes after undergoing TCAR in patients 70 years of age and older. METHODS: A retrospective review was completed of a dual institutional database between December 2015 and April 2022 to capture demographics, comorbidities, and perioperative results. The geriatric cohort was defined at a cutoff of 70 years. Univariate statistical testing between groups were completed with Student's T-test or Fisher's exact test at an α of .05 for continuous and categorical variables, respectively. RESULTS: 851 procedures were captured for statistical analysis. With age cutoff of 70 years, we generated 567 geriatric (78.4 ± 5.7 years) and 284 young (63.2 ± 5.7 years) patients. The older patients tended to have more baseline illness, as measured by a higher rate Charlson Comorbidity Index (4.4 ± 2.2 vs 6.0 ± 2.1, P < .01). Younger patients tended to be actively smoking (42.3% vs 17.6%, P < .01). Intraoperative variables were grossly similar by age, including blood loss (43.0 ± 45.0 vs 45.7 ± 50.3 mLs, P = .45), reverse flow time (9.0 ± 7.4 vs 9.0 ± 6.7 mins, P = .98), and technical success (98.9% vs 98.6%, P = .76). While we observed an increased rate of stroke in the older patients, this did not reach statistical significance (1.4% vs 2.6%, P = .33). There were no differences between age groups with respect to myocardial infarction (0% vs .5%, P = .55) and death (1.1% vs 1.1%, P > .99) in the 30-day perioperative period. CONCLUSION: We found that TCAR was not associated with age-related increases in adverse outcomes and can be considered a viable option when treating carotid artery stenosis in patients older than 70 years of age.

Multi-institutional patterns of clopidogrel response among patients undergoing transcarotid artery revascularization.

OBJECTIVE: Current guidelines recommend dual antiplatelet therapy (DAPT) in patients undergoing carotid artery stenting. The most common DAPT regimen is aspirin and clopidogrel, a P2Y12 receptor antagonist; however, the prevalence of clopidogrel resistance (CR) in patients undergoing percutaneous coronary interventions may exceed 60%. Few studies have investigated the prevalence and impact of CR in patients undergoing extracranial carotid artery stenting, particularly transcarotid artery revascularization (TCAR). METHODS: Consecutive high-risk patients ≥ 18 years who underwent TCAR for high grade (≥70%) and/or symptomatic (≥50%) carotid stenosis with preoperative P2Y12 testing between August 2019 and December 2021 were identified across five institutions. Preoperative platelet reactivity was measured with the VerifyNow P2Y12 Reaction Unit (PRU) Test (Instrumentation Laboratory, Bedford, MA), with CR defined as PRU ≥ 194 and hyper-response as PRU <70. Patients without preoperative P2Y12 testing within 30 days prior to TCAR or those on a non-clopidogrel P2Y12 inhibitor preoperatively were excluded. The primary outcome of interest was prevalence of CR. Secondary outcomes of interest included the incidence of ischemic and hemorrhagic complications. RESULTS: Of 92 patients identified, the majority were male (59%) and Caucasian (75%) with a mean age of 75 years (±8, range 56-92). Preoperatively, 93% of patients were on aspirin, 100% on clopidogrel, and 13% on therapeutic anticoagulation. At presentation, 36% were symptomatic. The mean preoperative P2Y12 was 156 PRU (±76, range 6-349). In total, 30 (33%) patients met criteria for CR (mean PRU 240 ± 37; range 197-349), and 15 (16%) met criteria for hyper-responder (mean PRU 38 ± 20; range 6-68). There was no significant difference by clopidogrel response phenotype in terms of sex (p = 0.246), race (p = 0.384), or symptomatic presentation (p = 0.956). Postoperatively, the cumulative incidence of stroke and MI was 2.1%, with no statistically significant difference in the incidence of in-hospital stroke (PRU 238, p = 0.489) or MI (PRU 168, p = 1) between clopidogrel phenotypes. Three (3.3%) patients, one CR (PRU 240) and two responders (PRU 119 and PRU 189), experienced postoperative access site hematomas that required no subsequent intervention. No other index hospitalization hemorrhagic complications occurred. CONCLUSIONS: Using preoperative P2Y12 testing with a threshold PRU ≥ 194 to define CR, we identified a high prevalence of CR in patients undergoing TCAR similar to that in the pre-existing coronary literature. We found no significant differences in postoperative ischemic or hemorrhagic complications by clopidogrel response phenotype, although complication rates in the overall study cohort were low. CR may be a spectrum from responder to partial responder to complete non-responder, and this may account for the differences in our CR cohort compared to the ROADSTER 2 protocol deviation cohort. Further investigation is warranted to determine if a quantitative assessment of CR is sufficient to identify patients at risk of developing secondary cerebrovascular ischemic events in this patient population.

Surgery or Endovascular Therapy for Chronic Limb-Threatening Ischemia.

BACKGROUND: Patients with chronic limb-threatening ischemia (CLTI) require revascularization to improve limb perfusion and thereby limit the risk of amputation. It is uncertain whether an initial strategy of endovascular therapy or surgical revascularization for CLTI is superior for improving limb outcomes. METHODS: In this international, randomized trial, we enrolled 1830 patients with CLTI and infrainguinal peripheral artery disease in two parallel-cohort trials. Patients who had a single segment of great saphenous vein that could be used for surgery were assigned to cohort 1. Patients who needed an alternative bypass conduit were assigned to cohort 2. The primary outcome was a composite of a major adverse limb event - which was defined as amputation above the ankle or a major limb reintervention (a new bypass graft or graft revision, thrombectomy, or thrombolysis) - or death from any cause. RESULTS: In cohort 1, after a median follow-up of 2.7 years, a primary-outcome event occurred in 302 of 709 patients (42.6%) in the surgical group and in 408 of 711 patients (57.4%) in the endovascular group (hazard ratio, 0.68; 95% confidence interval [CI], 0.59 to 0.79; P<0.001). In cohort 2, a primary-outcome event occurred in 83 of 194 patients (42.8%) in the surgical group and in 95 of 199 patients (47.7%) in the endovascular group (hazard ratio, 0.79; 95% CI, 0.58 to 1.06; P = 0.12) after a median follow-up of 1.6 years. The incidence of adverse events was similar in the two groups in the two cohorts. CONCLUSIONS: Among patients with CLTI who had an adequate great saphenous vein for surgical revascularization (cohort 1), the incidence of a major adverse limb event or death was significantly lower in the surgical group than in the endovascular group. Among the patients who lacked an adequate saphenous vein conduit (cohort 2), the outcomes in the two groups were similar. (Funded by the National Heart, Lung, and Blood Institute; BEST-CLI ClinicalTrials.gov number, NCT02060630.).

Transcarotid Revascularization Associated Extended Reverse Flow Duration is Not a Harbinger of Poor Perioperative Outcomes.

BACKGROUND: Transcarotid revascularization (TCAR) is a carotid stenting technique in which an external shunt between the common carotid artery and femoral vein is created to induce cerebral flow reversal as protection against procedure-related plaque embolism. We completed this analysis to determine if prolonged cerebral flow reversal was associated with adverse perioperative outcomes. METHODS: A retrospective review of a combined carotid revascularization database separately maintained at 2 high-volume TCAR health systems was completed. Procedures with captured intraoperative reverse flow duration was included, stratified into two cohorts at a cut-off of 8 mi, and examined with univariate analysis. RESULTS: Within the predesignated study period, 800 patients received a carotid stent via the TCAR technique at Indiana University Health (n = 350) and Memorial Hermann Health Systems (n = 450). In 132 of these procedures, the duration of reverse flow time was not captured and, therefore, excluded from further analysis. Using our prespecified cutoff for extended reverse flow duration (ERFD), we generated 256 cases, leaving an additional 412 procedures completed with a short reverse flow duration. Baseline comorbidities were comparable with respect to individual diagnoses but the overall disease burden in ERFD patients was slightly higher by Charlson Comorbidity Index (5.3 ± 0.1 vs. 5.7 ± 0.1, P = 0.02). With respect to indications and high anatomic risk criteria, both groups were similar, with exception of the presence of a surgically inaccessible carotid bifurcation, which was more frequent in the ERFD procedures (5.3% vs. 10.2%, P = 0.02). Intraoperatively, more blood loss (40.9 ± 2.2 vs. 48.9 ± 2.9 mLs, P = 0.03), operative time (55.2 ± 0.8 vs. 76.3 ± 1.6 min, P < 0.01), radiation (126.3 ± 17.5 vs. 281.9 ± 28.5 mGys, P < 0.01), contrast volume (19.9 ± 0.4 vs. 26.9 ± 0.9 mLs, P < 0.01), and fluoroscopy time (3.3 ± 0.8 vs. 6.3 ± 0.3 min, P < 0.01) were noted in the patients with extended flow reversal. However, this did not increase the risk of stroke (2.7% vs. 2.0%, P = 0.61), myocardial infarction (0.5% vs. 0%, P = 0.53), or death (1.2% vs. 0.4%, P = 0.41) in the 30-day perioperative period. CONCLUSIONS: Extended cerebral flow reversal, defined here as greater than 8 min, was not associated with increased risk of stroke, myocardial infarction, or death in this institutionally derived series.

Outcomes after transcarotid artery revascularization stratified by preprocedural symptom status.

OBJECTIVE: Previous studies on carotid endarterectomy and transfemoral carotid artery stenting demonstrated that perioperative outcomes differed according to preoperative neurologic injury severity, but this has not been assessed in transcarotid artery revascularization (TCAR). In this study, we examined contemporary perioperative outcomes in patients who underwent TCAR stratified by specific preprocedural symptom status. METHODS: Patients who underwent TCAR between 2016 and 2021 in the Vascular Quality Initiative were included. We stratified patients into the following groups based on preprocedural symptoms: asymptomatic, recent (symptoms occurring <180 days before TCAR) ocular transient ischemic attack (TIA), recent hemispheric TIA, recent stroke, or formerly symptomatic (symptoms occurring >180 days before TCAR). First, we used trend tests to assess outcomes in asymptomatic patients versus those with an increasing severity of recent neurologic injury (recent ocular TIA vs recent hemispheric TIA vs recent stroke). Then, we compared outcomes between asymptomatic and formerly symptomatic patients. Our primary outcome was in-hospital stroke/death rates. Multivariable logistic regression was used to adjust for demographics and comorbidities across groups. RESULTS: We identified 18,477 patients undergoing TCAR, of whom 62.0% were asymptomatic, 3.2% had a recent ocular TIA, 7.6a % had recent hemispheric TIA, 18.0% had a recent stroke, and 9.2% were formerly symptomatic. In patients with recent symptoms, we observed higher rates of stroke/death with increasing neurologic injury severity: asymptomatic 1.1% versus recent ocular TIA 0.8% versus recent hemispheric TIA 2.1% versus recent stroke 3.1% (Ptrend < .01). In formerly symptomatic patients, the rate of stroke/death was higher compared with asymptomatic patients, but this difference was not statistically significant (1.7% vs 1.1%; P = .06). After risk adjustment, compared with asymptomatic patients, there was a higher odds of stroke/death in patients with a recent stroke (odds ratio [OR], 2.8; 95% confidence interval [CI], 2.1-3.7; P < .01), a recent hemispheric TIA (OR, 2.0; 95% CI, 1.3-3.0; P < .01), and former symptoms (OR, 1.6; 95% CI, 1.1-2.5; P = .02), but there was no difference in stroke/death rates in patients with a recent ocular TIA (OR, 0.9; 95% CI, 0.4-2.2; P = .78). CONCLUSIONS: After TCAR, compared with asymptomatic status, a recent stroke and a recent hemispheric TIA were associated with higher stroke/death rates, whereas a recent ocular TIA was associated with similar stroke/death rates. In addition, a formerly symptomatic status was associated with higher stroke/death rates compared with an asymptomatic status. Overall, our findings suggest that classifying patients undergoing TCAR as symptomatic versus asymptomatic may be an oversimplification and that patients' specific preoperative neurologic symptoms should instead be used in risk assessment and outcome reporting for TCAR.