An International, Expert-Based Delphi Consensus Document on Controversial Issues about TransCarotid Artery Revascularization (TCAR).

OBJECTIVE: TransCarotid Artery Revascularization (TCAR) has emerged as an alternative therapeutic modality to carotid endarterectomy (CEA) and transfemoral carotid artery stenting (TFCAS) for the management of patients with carotid artery stenosis. However, certain issues regarding the indications and contraindications of TCAR remain unanswered or unresolved. The aim of this international, expert-based Delphi Consensus document was to attempt to provide some guidance on these topics. METHODS: A 3-Round Delphi Consensus process was performed including 29 experts. The aim of Round 1 was to investigate the differing views and opinions of the participants. Round 2 was carried out after the results from the literature on each topic were provided to the participants. During Round 3, the participants had the opportunity to finalize their vote. RESULTS: Most participants agreed that TCAR can/can probably/possibly be performed within 14 days of a cerebrovascular event, but it is best to avoid it in the first 48 hours. It was felt that TCAR cannot/should not replace TFCAS or CEA, as each procedure has specific indications and contraindications. Symptomatic patients >80 years should probably be treated with TCAR rather than with TFCAS. TCAR can/can probably be used for the treatment of restenosis following CEA/TFCAS. Finally, there is a need for a randomized controlled trial to provide better evidence for the unresolved issues. CONCLUSIONS: This Delphi Consensus document attempted to assist the decision-making of physicians/interventionalists/vascular surgeons involved in the management of carotid stenosis patients. Furthermore, areas requiring additional research were identified. Future studies and randomized controlled trials should provide more evidence to address the unanswered questions regarding TCAR.

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.

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.

Secondary interventions following open vs endovascular revascularization for chronic limb threatening ischemia in the BEST-CLI trial.

OBJECTIVES: Patients undergoing revascularization for chronic limb-threatening ischemia experience a high burden of target limb reinterventions. We analyzed data from the Best Endovascular versus Best Surgical Therapy in Patients with Critical Limb Ischemia (BEST-CLI) randomized trial comparing initial open bypass (OPEN) and endovascular (ENDO) treatment strategies, with a focus on reintervention-related study endpoints. METHODS: In a planned secondary analysis, we examined the rates of major reintervention, any reintervention, and the composite of any reintervention, amputation, or death by intention-to-treat assignment in both trial cohorts (cohort 1 with suitable single-segment great saphenous vein [SSGSV], n = 1434; cohort 2 lacking suitable SSGSV, n = 396). We also compared the cumulative number of major and all index limb reinterventions over time. Comparisons between treatment arms within each cohort were made using univariable and multivariable Cox regression models. RESULTS: In cohort 1, assignment to OPEN was associated with a significantly reduced hazard of a major limb reintervention (hazard ratio [HR], 0.37; 95% confidence interval [CI], 0.28-0.49; P < .001), any reintervention (HR, 0.63; 95% CI, 0.53-0.75; P < .001), or any reintervention, amputation, or death (HR, 0.68; 95% CI, 0.60-0.78; P < .001). Findings were similar in cohort 2 for major reintervention (HR, 0.53; 95% CI, 0.33-0.84; P = .007) or any reintervention (HR, 0.71; 95% CI, 0.52-0.98; P = .04). In both cohorts, early (30-day) limb reinterventions were notably higher for patients assigned to ENDO as compared with OPEN (14.7% vs 4.5% of cohort 1 subjects; 16.6% vs 5.6% of cohort 2 subjects). The mean number of major (mean events per subject ratio [MR], 0.45; 95% CI, 0.34-0.58; P < .001) or any target limb reinterventions (MR, 0.67; 95% CI, 0.57-0.80; P < .001) per year was significantly less in the OPEN arm of cohort 1. The mean number of reinterventions per limb salvaged per year was lower in the OPEN arm of cohort 1 (MR, 0.45; 95% CI, 0.35-0.57; P < .001 and MR, 0.66; 95% CI, 0.55-0.79; P < .001 for major and all, respectively). The majority of index limb reinterventions occurred during the first year following randomization, but events continued to accumulate over the duration of follow-up in the trial. CONCLUSIONS: Reintervention is common following revascularization for chronic limb-threatening ischemia. Among patients deemed suitable for either approach, initial treatment with open bypass, particularly in patients with available SSGSV conduit, is associated with a significantly lower number of major and minor target limb reinterventions.

Cytomegalovirus Infection Facilitates the Costimulation of CD57+CD28- CD8 T Cells in HIV Infection and Atherosclerosis via the CD2-LFA-3 Axis.

CD8 T cells are emerging as important mediators in atherosclerosis and cardiovascular disease (CVD). Immune activation may play a particular role in people with HIV (PWH) who are at an increased risk of CVD, even after controlling for known CVD risk factors. Latent CMV infection is associated with increased CVD risk for both PWH and people without HIV, and human CMV-specific CD4 and CD8 T cells are enriched for an immunosenescent phenotype. We previously showed that CMV coinfection in PWH promotes vascular homing and activation of inflammatory CD4 T cells through the CD2-LFA-3 axis. However, the role of CD2/LFA3 costimulation of CD8 T cells in PWH with CMV has yet to be described. In the present study, we demonstrate that CD2 expression on CX3CR1+CD57+CD28- inflammescent CD8 T cells is increased on cells from CMV-seropositive PWH. In vitro CD2/LFA-3 costimulation enhances TCR-mediated activation of these inflammatory CD8 memory T cells. Finally, we show that LFA-3 is highly expressed in aortas of SIV-infected rhesus macaques and in atherosclerotic plaques of people without HIV. Our findings are consistent with a model in which CMV infection enhances CD2 expression on highly proinflammatory CD8 T cells that can then be stimulated by LFA-3 expressed in the vasculature, even in the absence of CD28 costimulation. This model, in which CMV infection exacerbates toxic cytokine and granzyme production by CD8 T cells within the vasculature, highlights a potential therapeutic target in atherosclerosis development and progression, especially for PWH.

Female and male patients have similar outcomes after transcarotid artery revascularization in prospective trials.

OBJECTIVE: Sex disparities in outcomes after carotid revascularization have long been a concern, with several studies demonstrating increased postoperative death and stroke for female patients after either carotid endarterectomy or transfemoral stenting. Adverse events after transfemoral stenting are higher in female patients, particularly in symptomatic cases. Our objective was to investigate outcomes after transcarotid artery revascularization (TCAR) stratified by patient sex hypothesizing that the results would be similar between males and females. METHODS: We analyzed prospectively collected data from the Safety and Efficacy Study for Reverse Flow Used During Carotid Artery Stenting Procedure (ROADSTER)1 (pivotal), ROADSTER2 (US Food and Drug Administration indicated postmarket), and ROADSTER Extended Access TCAR trials. All patients had verified carotid stenosis meeting criteria for intervention (≥80% for asymptomatic patients and ≥50% in patient with symptomatic disease), and were included based on anatomical or clinical high-risk criteria for carotid stenting. Neurological assessments (National Institutes of Health Stroke Scale, Modified Rankin Scale) were obtained before and within 24 hours from procedure end by an independent neurologist or National Institutes of Health Stroke Scale-certified nurse. Patients were stratified by sex (male vs female). Baseline demographics were compared using χ2 and Fisher's exact tests where appropriate; primary outcomes were combination stroke/death (S/D) and S/D/myocardial infarction (S/D/M) at 30 days, and secondary outcomes were the individual components of S/D/M. Univariate logistic regression was conducted. RESULTS: We included 910 patients for analysis (306 female [33.6%], 604 male [66.4%]). Female patients were more often <65 years old (20.6% vs 15%) or ≥80 years old (22.6% vs 20.2%) compared with males, and were more often of Black/African American ethnicity (7.5% vs 4.3%). There were no differences by sex in term of comorbidities, current or prior smoking status, prior stroke, symptomatic status, or prevalence of anatomical and/or clinical high-risk criteria. General anesthetic use, stent brands used, and procedure times did not differ by sex, although flow reversal times were longer in female patients (10.9 minutes male vs 12.4 minutes female; P = .01), as was more contrast used in procedures for female patients (43 mL male vs 48.9 mL female; P = .049). The 30-day S/D and S/D/M rates were similar between male and female patients (S/D, 2.7% male vs 1.6% female [P = .34]; S/D/M, 3.6% male vs 2.6% female [P = .41]), which did not differ when stratified by symptom status. Secondary outcomes did not differ by sex, including stroke rates at 30 days (2.2% male vs 1.6% female; P = .80), nor were differences seen with stratification by symptom status. Univariate analysis demonstrated that history of a prior ipsilateral stroke was associated with increased odds of S/D (odds ratio [OR], 4.19; P = .001) and S/D/M (OR, 2.78; P = .01), as was symptomatic presentation with increased odds for S/D (OR, 2.78; P = .02). CONCLUSIONS: Prospective TCAR trial data demonstrate exceptionally low rates of S/D/MI, which do not differ by patient sex.

Direct oral anticoagulants over warfarin at discharge associated with improved survival and patency in infra-geniculate bypasses with prosthetic conduits.

OBJECTIVE: There is no consensus on the optimal anticoagulant regimen following lower extremity bypass. Historically, warfarin has been utilized for prosthetic or compromised vein bypasses. Direct-acting oral anticoagulants (DOACs) are increasingly replacing warfarin in this context, but their efficacy in bypass preservation has not been well-studied. Recent studies have shown that DOACs may improve outcomes following bypasses; however, it is unclear if this is dependent upon type of bypass conduit. The goal of this study was to evaluate whether a difference exists between vein and prosthetic infra-geniculate bypasses outcomes based on the anticoagulant utilized on discharge, warfarin or DOAC. METHODS: The Vascular Quality Initiative infra-inguinal bypass database was queried for all patients who underwent an infra-geniculate bypass and were anticoagulation-naive at baseline but were discharged on either warfarin or DOACs. A survival analysis was performed for patients up to 1 year to determine whether the choice of discharge anticoagulation was associated with differences between those with vein vs prosthetic conduits in overall survival, primary patency, risk of amputation, or risk of major adverse limb events (MALE). A multivariable Cox proportional hazards analysis was performed to control for differences in baseline demographic factors between the groups. RESULTS: During the study period (2003-2020), 57,887 patients underwent infra-geniculate bypass. Of these, 3230 (5.5%) were anticoagulated on discharge. There was a similar distribution of anticoagulation between vein (n = 1659; 51.4%) and prosthetic conduits (n = 1571; 48.6%). Thirty-two percent were discharged on DOACs, and 68.0% were discharged on warfarin. For prosthetic conduits, being discharged on a DOAC was associated with improved outcomes on univariate and multivariable analyses revealing lower risk of overall mortality (hazard ratio [HR], 0.61; 95% confidence interval [CI], 0.41-0.93; P = .021), loss of primary patency (HR, 0.70; 95% CI, 0.55-0.89; P = .003), risk of amputation (HR, 0.71; 95% CI, 0.54-0.93; P = .013), and risk of MALE (HR, 0.80; 95% CI, 0.64-1.00; P = .048). Patients with a vein bypass had improved univariate outcomes for survival and primary patency; however, with multivariable analysis, there were no significant differences in outcomes between DOAC and warfarin. CONCLUSIONS: Anticoagulation-naive patients who underwent an infra-geniculate prosthetic bypass had higher rates of overall survival, bypass patency, amputation-free survival, and freedom from MALE when discharged on a DOAC compared with warfarin. Those with vein bypasses had similar outcomes regardless of the choice of anticoagulation.

Chocolate Touch Versus Lutonix Drug-Coated Balloon for Femoropopliteal Lesions in Diabetes: The Chocolate Touch Study.

BACKGROUND: The randomized Chocolate Touch Study demonstrated that in patients undergoing treatment of femoropopliteal artery lesions, the Chocolate Touch drug-coated balloon (DCB) was safe and had superior efficacy at 12 months compared with the Lutonix DCB. We report the prespecified diabetes subanalysis comparing outcomes among patients with and without diabetes mellitus (DM). METHODS: Patients with claudication or ischemic rest pain (Rutherford class 2-4) were randomized to Chocolate Touch or Lutonix DCB. The primary efficacy endpoint was DCB success defined as primary patency at 12 months (peak systolic velocity ratio <2.4 by duplex ultrasound without clinically driven target lesion revascularization in the absence of bailout stenting). The primary safety endpoint was freedom from major adverse events at 12 months, a composite of target limb-related death, major amputation, or reintervention. RESULTS: A total of 313 patients (38% DM [n=119]) were randomized to either Chocolate Touch (n=66/152) or Lutonix DCB (n=53/161). Among patients with DM, DCB success was 77.2% and 60.5% (p=0.08), and in non-DM patients, DCB success was 80% and 71.3% (p=0.2114) for the Chocolate Touch and Lutonix DCB, respectively. The primary safety endpoint was similar for both cohorts regardless of DM status (interaction test, p=0.96). CONCLUSIONS: This randomized trial demonstrated similar safety and efficacy for the treatment of femoropopliteal disease with the Chocolate Touch DCB compared with using the Lutonix DCB regardless of DM status at 12 months. CLINICAL IMPACT: This substudy of the Chocolate Touch Study demonstrated similar safety and efficacy for treatment of femoropopliteal disease of the Chocolate Touch DCB compared with the Lutonix DCB regardless of diabetes (DM) status at 12 months. Endovascular therapy has become the therapy of choice for the treatment of most symptomatic femoropopliteal lesions regardless of DM status. These results give clinicians another option when treating femoropopliteal disease in this high-risk patient population.

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.

Anatomic Utility of Single Branched Thoracic Endograft During Thoracic Endovascular Aortic Repair.

INTRODUCTION: Single branched thoracic endografts (SBTEs) have been designed for pathology requiring zone 2 seal during thoracic endovascular aortic repair (TEVAR). Numerous criteria must be met to allow for their implantation. Our aim was to analyze anatomic suitability for a next generation SBTE. METHODS: We reviewed 150 TEVAR procedures between 2015 and 2019. Proximal seal was: zone 0 in 21 (16%), zone 1 in 4 (3%), zone 2 in 52 (40%), zone 3 in 45 (35%), and zone 4 or distal in 7 (5%). We analyzed the Zone 2 patient's angiograms and CT angiograms using centerline software to measure arterial diameters and length in relation to the left common carotid artery (LCCA), left subclavian artery (LSA) and proximal extent of aortic disease to determine if patients met anatomic criteria of a novel SBTE. RESULTS: Zone 2 average age was 64.4 ± 16.3 years; 34 patients were male (65%). Indications for repair were aneurysm (N = 9, 17%), acute dissection (N = 14, 27%), chronic dissection with aneurysmal degeneration (N = 7, 13%), intramural hematoma (N = 9, 17%), penetrating aortic ulcer (N = 5, 10%), and blunt traumatic aortic injury (BTAI, N = 8, 15%). LSA revascularization occurred in 27 patients (52%). Overall, 20 (38.5%) of the zone 2 patients met anatomic criteria. Patients with dissection met anatomic criteria less frequently than aneurysm (33% [10 of 30] vs 64% [9 of 14]). Patients treated for BTAI rarely met the anatomic criteria (1 of 8, 13%). The main anatomic constraints were an inadequate distance from the LCCA to the LSA takeoff and from the LCCA to the start of the aortic disease process. CONCLUSION: Less than half of patients who require seal in zone 2 met criteria for this SBTE. Patients with aneurysms met anatomic criteria more often than those with dissection. The device would have little applicability in treating patients with BTAI.

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.

Outcome after revascularization with paclitaxel-coated devices in patients with chronic limb-threatening ischemia.

OBJECTIVE: Data regarding the safety and efficacy of paclitaxel (PTX)-coated peripheral arterial devices for femoropopliteal artery (FPA) atherosclerotic disease is derived from studies that mainly evaluated patients with claudication. Outcomes of PTX treatment for patients with chronic limb-threatening ischemia (CLTI) is incompletely defined. This study compares outcome in patients with CLTI treated with and without PTX. METHODS: We retrospectively studied patients who underwent FPA intervention for an indication of CLTI in the Vascular Quality Initiative peripheral vascular intervention database from 2016 to 2020. Patients who had concomitant iliac or tibial interventions were included. One limb per patient was studied. Propensity score matching based on demographics, comorbidities, indication, and pharmacological therapy was performed to generate balanced cohorts. Kaplan-Meier survival analysis and multivariate Cox regression compared limb salvage, overall survival, primary patency, and major adverse limb events (MALE) between patients treated with and without PTX. RESULTS: Demographics, comorbidities, indications, and procedural details were similar between 14,065 PTX and 14,065 non-PTX propensity-matched patients. Kaplan-Meier analysis at 18-month follow-up demonstrated that the PTX group compared with the non-PTX group had a significantly higher rates of limb salvage (89.2% vs 86.5%; P < .001), primary patency (80.3% vs 76.9%; P < .001), and freedom from MALE (72.6% vs 67.9%; P < .001). Multivariate analysis also showed that PTX treatment was associated with a lower risk of major amputation (hazard ratio [HR], 0.74; 95% confidence interval [CI], 0.67-0.82; P < .001), loss of primary patency (HR, 0.80; 95% CI, 0.74-0.87; P < .001), and MALE (HR, 0.77; 95% CI, 0.72-0.82; P < .001). Overall, 21% of patients had a prior ipsilateral peripheral vascular intervention. Removing these patients from the analysis yielded similar results at 18 months. Overall survival at 54 months was not statistically different between the PTX and non-PTX groups in the overall cohort (73.5 vs 71.3%; P = .07), but significant in the de-novo treated patients (73.9% vs 70.7%; P = .02).Multivariate analyses showed a lower mortality risk in the PTX patients (HR, 0.93; 95% CI, 0.87-0.98; P = .02). CONCLUSIONS: FPA intervention with a PTX-coated device is associated with improved limb salvage, primary patency, and freedom from MALE at the 18-month follow-up compared with uncoated devices. This benefit was not associated with an increase in all-cause mortality out to 4.5 years. Further study is necessary to determine the optimal role for PTX in the treatment of the FPA for patients with CLTI and to understand its long-term outcome.

TransCarotid Artery Revascularization Can Be Safely Performed in Patients Undergoing Dialysis.

BACKGROUND: TransCarotid Artery Revascularization (TCAR) has been effectively performed to prevent stroke in patients with carotid artery stenosis (CS). Prior studies established that TCAR can be safely performed in high-risk patients such as octogenarians, patients with prior carotid endarterectomy (CEA), contralateral occlusion, and heavily calcified lesions. Hemodialysis patients are at an increased risk of exhibiting cardiovascular complications. This study aims to investigate how dialysis may affect TCAR outcomes. METHODS: The Vascular Quality Initiative (VQI) dataset was queried for patients undergoing TCAR from November 2016 to November 2021. Patients were divided into dialysis and nondialysis groups. The primary outcome was the composite endpoint of in-hospital stroke, death, or myocardial infarction (MI). Secondary outcomes were in-hospital stroke, stroke, or transient ischemic attack (TIA), death, prolonged length of stay (more than 1 day) (PLOS), MI, and stroke or death. Multivariable logistic regression analysis was used to assess in-hospital outcomes. Kaplan-Meier survival and log-rank test were used to assess 1-year survival. RESULTS: A total of 22,619 patients underwent TCAR during the study period. Of these, 327 patients were undergoing dialysis. On univariable analysis, dialysis patients were associated with a higher risk of mortality compared to nondialysis patients (1.2% vs. 0.6%, P = 0.030). However, after adjusting for potential confounders, this difference did not persist (odd ratio [OR]: 1.99, 95% confidence interval [CI] (0.8-4.9), P = 0.136). Dialysis patients were more likely to experience PLOS (OR: 1.6, 95% CI (1.2-2), P < 0.001). There was no difference between dialysis and nondialysis patients in the risk of stroke or death, stroke, stroke or TIA, MI, and stroke or death, or MI on univariable and multivariable analyses. At 1 year, the overall survival for dialysis versus nondialysis patients was 81.5% vs. 95.5%, P < 0.001. CONCLUSIONS: To our knowledge, this is the first study to date of dialysis patients who have undergone TCAR. We have shown that there was no difference in the risk of stroke, death, and MI between dialysis and nondialysis patients. Therefore, TCAR can be safely offered to patients undergoing dialysis. Future studies with larger number of patients are warranted to confirm these results.

Cortical Thinning in High-Grade Asymptomatic Carotid Stenosis.

BACKGROUND AND PURPOSE: High-grade carotid artery stenosis may alter hemodynamics in the ipsilateral hemisphere, but consequences of this effect are poorly understood. Cortical thinning is associated with cognitive impairment in dementia, head trauma, demyelination, and stroke. We hypothesized that hemodynamic impairment, as represented by a relative time-to-peak (TTP) delay on MRI in the hemisphere ipsilateral to the stenosis, would be associated with relative cortical thinning in that hemisphere. METHODS: We used baseline MRI data from the NINDS-funded Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis-Hemodynamics (CREST-H) study. Dynamic contrast susceptibility MR perfusion-weighted images were post-processed with quantitative perfusion maps using deconvolution of tissue and arterial signals. The protocol derived a hemispheric TTP delay, calculated by subtraction of voxel values in the hemisphere ipsilateral minus those contralateral to the stenosis. RESULTS: Among 110 consecutive patients enrolled in CREST-H to date, 45 (41%) had TTP delay of at least 0.5 seconds and 9 (8.3%) subjects had TTP delay of at least 2.0 seconds, the maximum delay measured. For every 0.25-second increase in TTP delay above 0.5 seconds, there was a 0.006-mm (6 micron) increase in cortical thickness asymmetry. Across the range of hemodynamic impairment, TTP delay independently predicted relative cortical thinning on the side of stenosis, adjusting for age, sex, hypertension, hemisphere, smoking history, low-density lipoprotein cholesterol, and preexisting infarction (P=0.032). CONCLUSIONS: Our findings suggest that hemodynamic impairment from high-grade asymptomatic carotid stenosis may structurally alter the cortex supplied by the stenotic carotid artery.

Use of direct-acting oral anticoagulants associated with improved survival and bypass graft patency compared with warfarin after infrageniculate bypass.

OBJECTIVE: No consensus has yet been reached regarding the optimal antiplatelet and anticoagulant regimen for patients after lower extremity bypass. Usually, patients who have undergone below-the-knee bypass will begin oral anticoagulation therapy. Historically, the bypass has been with prosthetic conduits and the anticoagulation therapy has been warfarin. However, the use of direct-acting oral anticoagulants (DOACs) has been increasing owing to their relative ease of dosing. The goal of the present study was to evaluate whether a difference exists in the postoperative outcomes for patients who have undergone infrageniculate bypass stratified by the use of on DOACs vs warfarin. METHODS: The Vascular Quality Initiative infrainguinal bypass database was queried for all patients who had undergone infrageniculate bypass, been anticoagulation naive at baseline, and been discharged with anticoagulation therapy. A survival analysis was performed for patients for ≤2 years postoperatively to determine whether discharge with warfarin vs DOACs was associated with differences in overall mortality, loss of primary patency, risk of amputation, and risk of major adverse limb events (MALE). A multivariable Cox proportional hazards analysis was performed to control for differences in the baseline demographic factors between the two groups. RESULTS: During the study period (2007-2020) 57,887 patients had undergone infrageniculate bypass. Of these patients, 2786 had been anticoagulation naive and discharged with either warfarin (n = 1889) or DOACs (n = 897). Discharge with a DOAC was associated with a lower risk of overall mortality (hazard ratio [HR], 0.62; 95% confidence interval [CI], 0.47-0.83; P = .001), loss of primary patency (HR, 0.74; 95% CI, 0.62-0.87; P < .001), risk of amputation (HR, 0.70; 95% CI, 0.57-0.86; P = .001), and risk of MALE (HR, 0.83; 95% CI, 0.71-0.97; P = .017). CONCLUSIONS: Anticoagulation-naive patients who had undergone infrageniculate bypass had had higher rates of overall survival, bypass patency, amputation-free survival, and freedom from MALE when discharged with a DOAC than with warfarin.

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.

Management and Outcome of Non-Aneurysmal Primary Aortic Infection.

INTRODUCTION: Aortic infection without prior intervention or aneurysm is exceedingly rare. We report the presentation, diagnosis, management, and outcome of patients with this unusual entity. METHODS: Retrospective chart and imaging review of patients with primary aortic infection. RESULTS: 5 patients (3 male, mean age 71.2 years) presented between 2014 and 2022. All had abdominal, back, or flank pain. Four had constitutional symptoms. All were evaluated with a complete blood count; 3 had leukocytosis. Both serum C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR) were elevated in the 4 patients evaluated with these tests. All were studied with peripheral blood culture on the first hospital day prior to any antibiotic administration. Blood culture was positive in only 1 patient. Computed tomography (CT) scan showed periaortic inflammation without aneurysm in all. Fluorodeoxyglucose positron emission tomography (PET) was obtained in 3 and a radiolabeled leukocyte single-photon emission CT (SPECT) scan was performed in 2. All demonstrated periaortic concentration of the radioisotope consistent with inflammation or infection. Intraoperative cultures were positive in 3. One patient who had a negative intraoperative culture was examined with broad range polymerase chain reaction (PCR) and DNA sequencing which identified a causative bacterium. The other patient with a negative intraoperative culture had periaortic abscess but was on antibiotics preoperatively, potentially confounding the culture. All patients underwent in-situ repair with rifampin impregnated polyester (N = 2), cryopreserved aortic allograft (N = 2), or autogenous femoral vein (N = 1). No patient developed recurrent infection or aortic related complications following surgery with an average follow up of 31.8 months (range 8-88 months). CONCLUSIONS: Patients with primary aortic infection present similarly with the triad of abdominal or back pain, laboratory markers of infection, and imaging demonstrating periaortic inflammation. Patients were treated successfully with in-situ repair. Preoperative identification of a causative organism was difficult, and PCR may be useful to help identify an organism.

Impact of interfacility transfer of ruptured abdominal aortic aneurysm patients.

OBJECTIVE: The interfacility transfer (IT) of patients with a ruptured abdominal aortic aneurysm (rAAA) occurs not infrequently to allow for a higher level of care. In the present study, we evaluated, using a contemporary administrative database, the effects of IT on mortality after rAAA repair. METHODS: The Healthcare Cost and Utilization Project Database for New York (2016) and New Jersey, Maryland, and Florida (2016-2017) was queried using the International Classification of Diseases, 10th edition, to identify patients who had undergone open or endovascular repair of AAAs. The hospitals were categorized into quartiles (Qs) per overall volume. The mortality rates for IT vs nontransferred (NT) rAAA patients stratified by treatment modality (open aneurysm repair of an rAAA [rOAR] vs endovascular aneurysm repair of an rAAA [rEVAR]) were compared. A Cox proportional hazard model was used to estimate the hazard ratios (HRs) for mortality. RESULTS: A total of 1476 patients had presented with a rAAA, of whom 673 (45.7%) were not treated. Of the remaining 803 patients, 226 (28.1%) were transferred, of whom 50 (22.1%) had died without repair after IT. The remaining 753 patients (IT, n = 176; NT, n = 576) had undergone rEVAR (n = 492) or rOAR (n = 261). The baseline characteristics were similar between the IT and NT patients, except for a greater proportion of black patients (P = .03), lower income families (P = .049), and rOAR (45.5% vs 31.4%; P = .001) for the IT patients. The overall mortality rates were similar between the NT (30.2%) and IT (27.3%) groups (P = .46). The subgroup analysis revealed that the operative mortality rates after rEVAR were similar between the NT and IT patients, without significant differences among the hospital quartiles. After rOAR, however, the operative mortality rates were lower for the IT patients, largely owing to improved outcomes in the Q4 hospitals (Q4 vs Q1-Q3, P = .001). Cox regression analysis demonstrated that age (HR, 1.03; 95% confidence interval, 1.00-1.06; P = .02) and treatment at a low-volume hospital (Q1-Q3; HR, 1.89; 95% confidence interval, 1.02-3.51; P = .04) were predictors of mortality. The total charges were similar (IT, $286,727; vs NT, $265,717; P = .38). CONCLUSIONS: The results from the present study have shown that <30% of rAAA patients deemed a candidate for repair will be transferred. We found that IT did not affect the mortality rates after rEVAR, irrespective of the hospital volume. For rOAR candidates, however, regionalization of care with prompt transfer to a high-volume center could improve the survival benefits without increased healthcare costs.

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.