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.).

Long-term outcomes of great saphenous vein harvest techniques for infrainguinal arterial bypass in a Medicare-matched registry database.

OBJECTIVE: Long-term outcomes for harvesting techniques for great saphenous vein (GSV) and its impact on the outcomes of infrainguinal arterial bypass remains largely unknown. Endoscopic GSV harvesting (EVH) has emerged as a less invasive alternative to conventional open techniques. Using the Vascular Quality initiative Vascular Implant Surveillance & Interventional Outcomes Network (VQI-VISION) database, we compared the long-term outcomes of infrainguinal arterial bypass using open and endoscopic GSV harvest techniques. METHODS: Patients who underwent infrainguinal GSV bypass between 2010 and 2019 were identified in the VQI-VISION Medicare linked database. Long-term outcomes of major/minor amputations, and reinterventions up to 5 years of follow-up were compared between continuous incisions, skip incision, and EVH, with continuous incisions being the reference group. Secondary outcomes included 30- and 90-day readmission, in addition to surgical site infections and patency rates at 6 months to 2 years postoperatively. Survival analysis using Kaplan-Meier curves and Cox regression hazard models were utilized to compare outcomes between groups. To adjust for multiple comparisons between the study groups, a P value of 2.5% was considered significant. RESULTS: Among the 8915 patients included in the study, continuous and skip vein harvest techniques were used in 44.4% and 43.4% of cases each, whereas 12.3% underwent EVH. The utilization of EVH remained relatively stable at around 12% throughout the study period. Compared with GSV harvest using continuous incisions, EVH was associated with higher rates of reintervention at 1 year (46.5% vs 41.3%; adjusted hazard ratio [aHR], 1.22; 95% confidence interval [CI], 1.06-1.41; P = .01]. However, no significant difference was observed between EVH and continuous incisions, and between skip and continuous incisions in terms of long-term reintervention or major and minor amputations on adjusted analysis. Compared with continuous incision vein harvest, both EVH and skip incisions were associated with lower surgical site infection rates within the first 6 months post-bypass (aHR, 0.53; 95% CI, 0.35-0.82 and aHR, 0.68; 95% CI, 0.53-0.87, respectively). Loss of primary, primary-assisted, and secondary patency was higher after EVH compared with continuous incision vein harvest. Among surgeons performing EVH, comparable long-term outcomes were observed regardless of low (<4 cases/year), medium (4-7 cases/year), or high procedural volumes (>7 cases/year). CONCLUSIONS: Despite higher 1-year reintervention rates, EVH for infrainguinal arterial bypass is not associated with a significant difference in long-term reintervention or amputation rates compared with other harvesting techniques. These outcomes are not influenced by procedural volumes for EVH technique.

Predictors of prolonged length of stay after elective carotid revascularization.

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

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

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

Reduction of Major Amputations after Surgery Versus Endovascular Intervention: The BEST-CLI Randomised Trial.

OBJECTIVE: BEST-CLI, an international randomised trial, compared bypass surgery with endovascular treatment in chronic limb threatening ischaemia (CLTI). In this substudy, overall amputation rates and risk of major amputation as an initial or subsequent outcome were evaluated. METHODS: A total of 1 830 patients were randomised to receive surgical or endovascular treatment:(1) patients with adequate single segment great saphenous vein (SSGSV) (n = 1 434); and (2) patients without adequate SSGSV (n = 396). Differences in time to first event and number of amputations were evaluated. RESULTS: In cohort 1, 410 (45.6%) total amputation events occurred in the surgical group vs. 490 (54.4%) in the endovascular group (p = .001) during mean follow up of 2.7 years. Every third patient underwent minor amputation after index revascularisation: 31.5% of the surgical group vs. 34.9% in the endovascular group (p = .17). Subsequent major amputation was required significantly less often in the surgical group compared with the endovascular group (15.0% vs. 25.6%; p = .002). The first amputation was major in 5.6% of patients in the surgical and 6.0% in the endovascular group (p = .72). Major amputation was required in 10.3% (n = 74/718) of patients in the surgical group and 14.9% (n = 107/716) in the endovascular group (p = .008). In cohort 2, 199 amputation events occurred in 132 (33.3%) patients during mean follow up of 1.6 years: 95 (47.7%) in the surgical vs. 104 (52.3%) in the endovascular group (p = .49). Major amputation was required in 15.2% (n = 30/197) of the patients in the surgical and 14.1% (n = 28/199) in the endovascular group (p = .74). CONCLUSION: In patients with CLTI, surgical bypass with SSGSV was more effective than endovascular treatment in preventing major amputations because of a decrease in major amputations subsequent to minor amputations.

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.

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.

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.

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.

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.

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.

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.

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.

TransCarotid Revascularization With Dynamic Flow Reversal Versus Carotid Endarterectomy in the Vascular Quality Initiative Surveillance Project.

OBJECTIVE: To compare the outcomes of TCAR with flow reversal to the gold standard CEA using data from the Society for Vascular Surgery Vascular Quality Initiative TCAR Surveillance Project. SUMMARY OF BACKGROUND DATA: TCAR is a novel minimally invasive procedure for carotid revascularization in high-risk patients that is associated with significantly lower stroke rates compared with carotid artery stenting via the transfemoral approach. METHODS: Patients in the United States and Canada who underwent TCAR and CEA for carotid artery stenosis (2016-2019) were included. Propensity scores were calculated based on baseline clinical variables and used to match patients in the 2 treatment groups (n = 6384 each). The primary endpoint was the combined outcome of perioperative stroke and/or death. RESULTS: No significant differences were observed between TCAR and CEA in terms of in-hospital stroke/death [TCAR, 1.6% vs CEA, 1.6%, RR (95% CI): 1.01 (0.77-1.33), P = 0.945], stroke [1.4% vs 1.4%, RR (95% CI): 1.02 (0.76-1.37), P = 0.881], or death [0.4% vs 0.3%, RR (95% CI): 1.14 (0.64-2.02), P = 0.662]. Compared to CEA, TCAR was associated with lower rates of in-hospital myocardial infarction [0.5% vs 0.9%, RR (95% CI): 0.53 (0.35-0.83), P = 0.005], cranial nerve injury [0.4% vs 2.7%, RR (95% CI): 0.14 (0.08-0.23), P < 0.001], and post-procedural hypertension [13% vs 18.8%, RR (95% CI): 0.69 (0.63-0.76), P < 0.001]. They were also less likely to stay in the hospital for more than 1 day [26.4% vs 30.1%, RR (95% CI): 0.88 (0.82-0.94), P < 0.001]. No significant interaction was observed between procedure and symptomatic status in predicting postoperative outcomes. At 1 year, the incidence of ipsilateral stroke or death was similar between the 2 groups [HR (95% CI): 1.09 (0.87-1.36), P = 0.44]. CONCLUSIONS: This propensity-score matched analysis demonstrated significant reduction in the risk of postoperative myocardial infarction and cranial nerve injury after TCAR compared to CEA, with no differences in the rates of stroke/death.

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.

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.

One-year outcomes after transcarotid artery revascularization (TCAR) in the ROADSTER 2 trial.

OBJECTIVES: Transcarotid artery revascularization (TCAR) is a carotid stenting technique that utilizes reversal of cerebral arterial flow to confer cerebral protection. Although carotid endarterectomy (CEA) remains the standard for treatment of symptomatic and asymptomatic carotid stenosis, the search for the optimal minimally invasive option for the high-risk surgical patient continues. The goal of the current study is to evaluate the 1-year safety and efficacy of TCAR in a prospective clinical trial. METHODS: ROADSTER 2 is a prospective, open-label, single-arm, multicenter, post-approval registry for patients undergoing TCAR. All patients were considered high risk for CEA and underwent independent neurological assessments preoperatively, postoperatively, and had long-term clinical follow-up. The primary end point was incidence of ipsilateral stroke after treatment with the ENROUTE Transcarotid Stent System. Secondary end points included individual/composite rates of stroke, death, and perioperative myocardial infarction. RESULTS: Between June 2016 and November 2018, 155 patients at 21 centers in the United States and one in the European Union were enrolled and represented a subset of the overall trial. Asymptomatic (n = 119; 77%) and symptomatic patients (n = 36; 23%) with high-risk anatomic (ie, high lesion, restenosis, radiation injury; 43%), physiologic (32%), or combined factors (25%) were enrolled. No patient suffered a perioperative myocardial infarction or stroke. Over the year, no patient had an ipsilateral stroke, but four patients died (2.6%), all from non-neurological causes. Additionally, a technical success rate of 98.7% with a low cranial nerve deficit rate of 1.3% was achieved. CONCLUSIONS: In patients with high risk factors, TCAR yields high technical success with a low stroke and death rate at 1 year. Further comparative studies with CEA are warranted.

Balloon dilation strategy does not affect outcomes for transcarotid artery revascularization in prospective trials.

OBJECTIVES: Strategies of balloon dilation during transfemoral carotid artery stenting include prestent dilation only (PRE), post-stent dilation only (POST), or both predilation and postdilation (PRE+POST). Concerns over higher neurological risk have been raised with POST and PRE+POST during transfemoral carotid artery stenting. Whether these concerns are applicable to transcarotid artery revascularization (TCAR), which uses proximal clamping and cerebral blood flow reversal during stent deployment and balloon angioplasty remains unknown. Our aim is to analyze outcomes of PRE, POST, or PRE+POST balloon dilation strategies during TCAR. METHODS: We analyzed the prospectively collected data from the ROADSTER1 (pivotal), ROADSTER2 (US Food and Drug Administration indicated postmarket), and ROADSTER Extended Access TCAR trials. All trial patients had a high risk anatomic or clinical factors for carotid endarterectomy and were included, unless they did not undergo stent deployment or balloon dilation. For trial inclusion, asymptomatic patients had a carotid stenosis of more than 80%, and symptomatic patients had stenosis of more than 50%. Primary outcome measures were stroke, death, and myocardial infarction (MI) at 30 days. Data were statistically analyzed with χ2, analysis of variance, and multivariable analysis, as appropriate. RESULTS: There were 851 patients (566 male) who underwent dilation by PRE (n = 216), POST (n = 249), or PRE+POST (n = 386). Patients had carotid stenosis of greater than 70% (n = 828, 97%), and 207 (24%) were symptomatic. Flow reversal times were longer in the PRE+POST group (PRE 10.2 minutes, POST 9.8 minutes, and PRE+POST 13.3 minutes; P < .001). The 30-day stroke rate for the whole cohort was 1.9%, mortality was 0.5%, and MI rate was 0.94%. Stroke rates for the PRE cohort (1.9%), POST cohort (2.0%), and PRE+POST cohort (1.8%; P = .98) were similar. Also, death rates at 30 days, and composite stroke, death, and MI rates were similar in the three cohorts. No significant differences in adverse outcomes were noted among the various dilation strategies for both symptomatic and asymptomatic patients. CONCLUSIONS: Based on these prospective trial data, there is no difference in neurological complications owing to balloon dilation strategy during TCAR. The balloon dilation technique best suited to the patient's specific lesion morphology should be used. Further studies are needed to evaluate the relationship of these dilation strategies to long-term outcomes, including stent patency, restenosis, and reintervention.

Vascular and Endovascular Surgical Procedural Skills Training: Survey of Vascular Surgery Program Directors About Extracurricular Vascular Surgical Educational Courses for Vascular Trainees.

BACKGROUND: Over the past decade, there has been an increase in the number of Vascular Surgery Educational Courses (VSEC) provided by academic institutions, regional and national vascular surgical societies, as well as industry partners. Each course has its own curriculum and how these curricula align with the modern needs of vascular surgery trainees are unclear. As such, there is a lack of unified content, syllabus, and trainee evaluations/feedback of these courses. The Education Committee for the Association for Program directors in Vascular Surgery (APDVS) was tasked to survey vascular surgery Program directors (PDs) and Associate Program directors (APDs) across the country to investigate the educational value, utility, and feedback provided from these VSEC. METHODS: A comprehensive list of vascular surgery educational courses across the country was generated. A 21-question survey was constructed and forwarded to all members of APDVS. The survey was directed at obtaining data from the vascular surgery program director/associate program directors about their understanding of the VSEC and what they valued as critical for their trainees. In addition, we sought to gauge the feedback provided by these courses to the vascular surgery trainees, and their PD/APDs. RESULTS: The survey was sent to 170 active members of APDVS with an overall response rate of 41%. The majority of the respondents 57 (81%) were PDs. Of all the PD/APDs, 5 (7%) reported that they knew of less than 5 such programs, 26 (37%) reported knowledge of 6-10 courses, 20 (29%) reported 11-20 courses, and 19 (27%) reported knowing more than 20 such programs. 49 (70%) of those surveyed reported that their trainees benefit from these courses. Statisticallysignificant factors impacting the decision to make adjustments to the individual training program included PGY-5 residents attending the educational courses, feedback from VSEC, and positive feedback from trainees attending the courses (all P < 0.05). When asked about their wants of VSEC, 35% desired mock oral exams, and 31% looked for cadaver dissections. Of the 24 PD/APD's who made adjustments to their program based on the feedback from the educational programs, those who held the title for 5-10 years were the most willing to make any changes 13 (54%), and those with more than ten years of experience 2 (8%), were the least willing to make any changes (P < 0.05). The majority of the PD/APDs 32 (46%) felt that the regional societal meetings are the best place to hold educational courses. 38 (55%) of PD/APD's received no feedback from the VSEC course directors. 41 (59%) of the programs provide some financial support for their trainees to attend these courses and 65 (92%) of the PD/APDs suggest that industry partners should provide the financial support for attending VSEC. CONCLUSIONS: This unique survey explores the attitude of vascular surgery educators about outside vascular surgery educational courses offered by various groups and industry. It is important to create standardized curricula for vascular surgery educational courses with collaborative oversight by educational/simulation key opinion leaders, PD/APD's, course directors and industry partners. Exploring benchmarks for standardization of the curricula offered by these outside educational opportunities would streamline the needs of our vascular surgery trainees and minimize time away from home institutions. Feedback identifying vascular trainees' strengths and areas for improvement to PD/APDs would be of great educational value and is currently a missed opportunity.