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This comparative effectiveness research compares the rates of adverse events for patients who underwent revascularization for carotid artery stenosis in centers that adopted transcarotid artery revascularization vs those that did not., Key Points Question Is the adoption of transcarotid artery revascularization (TCAR) associated with a center’s overall rate of perioperative cardiovascular events after carotid revascularization? Findings In this comparative-effectiveness study of 7664 patients who underwent TCAR and 78 363 patients who underwent carotid endarterectomy at 469 centers in North America, centers that adopted TCAR had a lower likelihood of perioperative cardiovascular events than if the centers had not adopted the new procedure. Meaning These findings suggest that the adoption of TCAR as an option for selected patients is associated with an improvement in perioperative outcomes for carotid revascularization overall at centers performing the procedure., Importance Transcarotid artery revascularization (TCAR) may serve as a safer alternative to carotid endarterectomy (CEA) for certain patients with carotid artery stenosis. Objective To determine the center-level association of TCAR adoption with overall perioperative outcomes for TCAR and CEA combined at centers performing both procedures. Design, Setting, and Participants This comparative-effectiveness research was conducted with a difference-in-difference analysis using retrospective data from 2015 to 2019 from the Vascular Quality Initiative registry, a consortium of more than 400 centers in North America. Included patients underwent TCAR or CEA for carotid artery stenosis. Patients who underwent transfemoral carotid stenting were excluded. Data were analyzed from December 2019 through August 2020. Exposures Center-level adoption of TCAR vs not. Main Outcomes and Measures The rate of major adverse cardiovascular events (MACE), a composite of in-hospital stroke, myocardial infarction, or death at 30 days, was measured. Results Among 86 027 patients who underwent revascularization for carotid artery stenosis, 7664 patients (8.9%) underwent TCAR (mean [SD] age, 73.1 [9.6] years; 2788 [36.4%] women; 6938 White patients [90.6%]; and 3741 patients with symptoms [48.8%]) and 78 363 patients (91.1%) underwent CEA (mean [SD] age, 70.6 [9.2] years; 30 928 [39.5%] women; 70 663 White patients [90.2%]; and 37 883 patients with symptoms [48.3%]). The number of centers performing both TCAR and CEA increased from 15 centers in 2015 to 247 centers in 2019, a more than 16-fold increase. The proportion of all carotid procedures that were TCARs increased from 90 of 12 276 (0.7%) in 2015 to 2718 of 15 956 (17.0%) in 2019, a 24-fold increase. Overall, the crude rate of MACE was similar for TCAR and CEA (178 patients [2.3%] after TCAR vs 1842 patients [2.4%] after CEA; P = .91). However, the rate of MACE over time decreased for CEA (406 of 16 404 patients [2.5%] in 2015 vs 189 of 10 097 patients [1.9%] in 2019; P for trend

Paclitaxel (PTX)-coated peripheral arterial devices have been shown to decrease femoropopliteal artery restenosis and the need for reintervention compared with non-PTX-coated devices. The data regarding PTX efficacy and safety come from randomized controlled trials that almost exclusively enrolled patients with claudication. The outcomes of PTX treatment in patients who present with chronic limb-threatening ischemia (CLTI) are unknown. This study compares long-term outcomes in patients with CLTI treated with and without PTX.We retrospectively reviewed 983 patients with CLTI treated with femoropopliteal artery angioplasty, atherectomy, stent, or combination between 2011 and 2019. Procedures were performed with additional proximal or distal tibial interventions as needed. Kaplan-Meier survival analysis and multivariable Cox-regression analysis compared overall survival (OS), amputation-free survival (AFS), freedom from major amputation (ff-MA), and freedom from target vessel revascularization (ff-TVR) between patients treated with and without PTX.Demographics, comorbidities, and Rutherford class were similar between 574 PTX (58.5%) and 409 non-PTX (41.6%) patients except that non-PTX patients were more likely to be male (56.2% vs 49.7%), dialysis dependent (19.6% vs 14.3%), and have higher average creatinine (2.3 vs 1.8 mg/dL). Through 4-year follow-up, the PTX group demonstrated a significant increase in OS (56.2% vs 43.9%, P = .013), AFS (52.6% vs 36.1%, P .0001), ff-MA (87.4% vs 78.7%, P = .0007), and ff-TVR (77.6% vs 70.6%, P = .012). Multivariable Cox-regression analysis demonstrated that PTX treatment was associated with improved OS, AFS, ff-MA, and ff-TVR.In patients with CLTI, treatment with a PTX-coated device is associated with improved OS, AFS, ff-MA, and ff-TVR through 4-year follow-up. PTX-coated devices may be especially beneficial in patients who present with CLTI.

The current risk assessment for patients with carotid atherosclerosis relies primarily on measuring the degree of stenosis. More reliable risk stratification could improve patient selection for targeted treatment. We have developed and validated a model to predict for major adverse neurologic events (MANE; stroke, transient ischemic attack, amaurosis fugax) that incorporates a combination of plaque morphology, patient demographics, and patient clinical information.We enrolled 221 patients with asymptomatic carotid stenosis of any severity who had undergone computed tomography angiography at baseline and ≥6 months later. The images were analyzed for carotid plaque morphology (plaque geometry and tissue composition). The data were partitioned into training and validation cohorts. Of the 221 patients, 190 had complete records available and were included in the present analysis. The training cohort was used to develop the best model for predicting MANE, incorporating the patient and plaque features. First, single-variable correlation and unsupervised clustering were performed. Next, several multivariable models were implemented for the response variable of MANE. The best model was selected by optimizing the area under the receiver operating characteristic curve (AUC) and Cohen's kappa statistic. The model was validated using the sequestered data to demonstrate generalizability.A total of 62 patients had experienced a MANE during follow-up. Unsupervised clustering of the patient and plaque features identified single-variable predictors of MANE. Multivariable predictive modeling showed that a combination of the plaque features at baseline (matrix, intraplaque hemorrhage [IPH], wall thickness, plaque burden) with the clinical features (age, body mass index, lipid levels) best predicted for MANE (AUC, 0.79), In contrast, the percent diameter stenosis performed the worst (AUC, 0.55). The strongest single variable for discriminating between patients with and without MANE was IPH, and the most predictive model was produced when IPH was considered with wall remodeling. The selected model also performed well for the validation dataset (AUC, 0.64) and maintained superiority compared with percent diameter stenosis (AUC, 0.49).A composite of plaque geometry, plaque tissue composition, patient demographics, and clinical information predicted for MANE better than did the traditionally used degree of stenosis alone for those with carotid atherosclerosis. Implementing this predictive model in the clinical setting could help identify patients at high risk of MANE.

Both transfemoral carotid artery stenting (TF-CAS) and transcarotid artery revascularization (TCAR) are competing endovascular alternatives to carotid endarterectomy for the treatment of atherosclerotic carotid artery stenosis. TF-CAS is an endovascular procedure associated with a long learning curve and higher periprocedural stroke and death rates during an operator's early experience. Estimates suggest that more than 50 cases are required to achieve outcomes similar to carotid endarterectomy. TCAR is a novel hybrid procedure combining direct common carotid artery access and cerebral blood flow reversal with carotid stent placement. In distinction from TF-CAS, TCAR has a rather short learning curve. A multi-institutional analysis showed that operators achieved technical proficiency after approximately 10 to 15 cases. This was reinforced by a large Society for Vascular Surgery, Vascular Quality Initiative Transcarotid Artery Revascularization Surveillance Project analysis that demonstrated that expertise peaked after approximately 20 cases. Both studies found that TCAR was not associated with an increased rate of stroke or death during operator's early experience. These data suggest that TCAR is readily learned and patients are not at increased risk during a surgeon's early experience.

Atherosclerotic cardiovascular disease (ASCVD) remains an important cause of morbidity in the general population and risk for ASCVD is increased approximately 2-fold in persons living with HIV infection (PLWH). This risk is linked to elevated CD8 T cell counts that are abundant in atherosclerotic plaques and have been implicated in disease pathogenesis yet the mechanisms driving T cell recruitment to and activation within plaques are poorly defined. Here we investigated the role of CD8 T cells in atherosclerosis in a non-human primate model of HIV infection and in the HIV-uninfected elderly; we sought to identify factors that promote the activation, function, and recruitment to endothelium of CX3CR1+ CD8 T cells. We measured elevated expression of CX3CL1 and IL-15, and increased CD8 T cell numbers in the aortas of rhesus macaques infected with SIV or SHIV, and demonstrated similar findings in atherosclerotic vessels of HIV-uninfected humans. We found that recombinant TNF enhanced the production and release of CX3CL1 and bioactive IL-15 from aortic endothelial cells, but not from aortic smooth muscle cells. IL-15 in turn promoted CX3CR1 surface expression on and TNF synthesis by CD8 T cells, and IL-15-treated CD8 T cells exhibited enhanced CX3CL1-dependent chemoattraction toward endothelial cells in vitro. Finally, we show that CD8 T cells in human atherosclerotic plaques have an activated, resident phenotype consistent with in vivo IL-15 and CX3CL1 exposure. In this report, we define a novel model of CD8 T cell involvement in atherosclerosis whereby CX3CL1 and IL-15 operate in tandem within the vascular endothelium to promote infiltration by activated CX3CR1+ memory CD8 T cells that drive further endothelial activation via TNF. We propose that these interactions are prevalent in aging and in PLWH, populations where circulating activated CX3CR1+ CD8 T cell numbers are often expanded., Author summary People living with HIV infection and elderly HIV-uninfected persons have increased risk of developing atherosclerotic cardiovascular disease, and have increased numbers and/or proportions of CD8 T cells that express the vascular endothelium-homing receptor CX3CR1. Atherosclerotic plaques contain many activated CD8 T cells, which have been implicated in disease pathogenesis, yet the mechanisms driving T cell recruitment to and activation within plaques are not clear. Here we propose a model in which CX3CR1+ CD8 T cells promote endothelial dysfunction by the combined effects of CX3CL1, IL-15, and TNF. Persistent inflammation triggers endothelial cell activation and dysfunction in people living with HIV infection. Endothelial cell-derived CX3CL1 then directs the migration of CX3CR1+ T cells to the activated endothelium where IL-15 activates T cells to express TNF. TNF drives endothelial expression of CX3CL1 and IL-15, providing a feed-forward loop of activation. We provide evidence that these pathways are active in human atherosclerotic plaques and in the aortic endothelium of SIV/SHIV-infected rhesus macaques. We propose these mechanisms of T cell-induced endothelial damage are operative in traditional risk factor-associated atherosclerosis in the general population and are accelerated in people with HIV infection who live in a state of sustained chronic inflammation.

Background and Purpose: Transcarotid artery revascularization (TCAR) is comprised of carotid artery stent placement with cerebral protection via proximal carotid artery clamping and reversal of cerebral arterial flow. The aim of the present study was to evaluate the safety and efficacy of TCAR performed by a broad group of physicians with variable TCAR experience. Methods: The ROADSTER 2 study is a prospective, open label, single arm, multicenter, postapproval registry for patients undergoing TCAR. Patients considered at high risk for complications from carotid endarterectomy with symptomatic stenosis ≥50% or asymptomatic stenosis ≥80% were included. The primary end point was procedural success, which encompassed technical success plus the absence of stroke, myocardial infarction, or death within the 30-day postoperative period. Secondary end points included technical success and individual/composite rates of stroke, death, and myocardial infarction (MI). All patients underwent independent neurological assessments before the procedure, within 24 hours, and at 30 days after TCAR. An independent clinical events committee adjudicated all major adverse events. Results: Between 2015 and 2019, 692 patients (Intent to Treat Population) were enrolled at 43 sites. Sixty cases had major protocol violations, leaving 632 patients adhering to the Food and Drug Administration-approved protocol (per-protocol population). The majority (81.2%) of operators were TCAR naïve before study initiation. Patients underwent TCAR for neurological symptoms in 26% of cases, and all patients had high-risk factors for carotid endarterectomy (anatomic-related 44%; physiological 32%; both 24%). Technical success occurred in 99.7% of all cases. The primary end point of procedural success rate in the Intent to Treat population was 96.5% (per-protocol 97.9%). The early postoperative outcomes in the Intent to Treat population included stroke in 13 patients (1.9%), death in 3 patients (0.4%), and MI in 6 patients (0.9%). The composite 30-day stroke/death rate was 2.3%, and stroke/death/MI rate was 3.2%. In the per-protocol population, there were strokes in 4 patients (0.6%), death in one patient (0.2%), and MI in 6 patients (0.9%) leading to a composite 30-day stroke/death rate of 0.8% and stroke/death/MI rate of 1.7%. Conclusions: TCAR results in excellent early outcomes with high technical success combined with low rates of postprocedure stroke and death. These results were achieved by a majority of operators new to this technology at the start of the trial. Adherence to the study protocol and peri-procedural antiplatelet therapy optimizes outcomes. Longer-term follow-up data are needed to confirm these early outcomes. Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT02536378.

Background: Despite current guidelines suggesting a benefit for dual antiplatelet therapy (DAPT) following peripheral vascular intervention (PVI), there are limited data on antiplatelet prescribing patterns post-procedure. We attempted to determine variables associated with DAPT prescription following lower extremity PVI. Methods: Retrospective analysis of patients undergoing lower extremity PVI in the Vascular Quality Initiative (2017–2018) was performed. Participants not on anticoagulation or DAPT before the procedure were considered for the final analysis. Postdischarge antiplatelet therapy regimen rates were determined (none, aspirin only, P2Y12 inhibitor only, and DAPT). Multivariate logistic regression was performed to determine variables associated with DAPT initiation compared with those discharged on single-agent or no antiplatelet therapy. Results: A total of 16 597 procedures were included for analysis, with 49% initiated on DAPT post-PVI. Male sex (odds ratio [OR], 1.12 [95% CI, 1.05–1.20]), smoking (OR, 1.20 [95% CI, 1.09–1.32]), and coronary artery disease (OR, 1.19 [95% CI, 1.11–1.27]) were associated with an increased likelihood of post-PVI DAPT prescription. Procedures requiring multiple types of interventions (OR, 1.28 [95% CI, 1.15–1.42]), stent placement (OR, 1.16 [95% CI, 1.06–1.27]), and with complications (OR, 1.31 [95% CI, 1.14–1.52]) were also positively associated with DAPT prescription. Conclusions: In patients not already receiving anticoagulation or on DAPT at the time of lower extremity PVI, prescription of DAPT following intervention is ≈50%. Multiple factors were associated with the decision for DAPT versus single antiplatelet therapy, and further study is required to understand how this affects postintervention adverse limb and cardiovascular events.

Transcarotid artery revascularization (TCAR) using a flow-reversal neuroprotection system has gained popularity for the endovascular treatment of carotid artery atherosclerotic disease owing to its lower risk of stroke or death compared with transfemoral carotid artery stenting. However, specific risk factors associated with stroke or death complications after TCAR have yet to be defined.All patients undergoing TCAR for the treatment of asymptomatic or symptomatic atherosclerotic carotid disease were identified between September 2016 and September 2019 in the Vascular Quality Initiative TCAR Surveillance Project. Our primary outcome was 30-day stroke or death. We created a risk model for 30-day stroke or death using multivariable fractional polynomials and internally validated the model using bootstrapping.During the study period 7633 patients underwent TCAR, of which 4089 (53.6%) were treated for symptomatic and 3544 (46.4%) for asymptomatic disease. The average age of patients undergoing TCAR was 73.3 ± 9.1 years and 63.7% were male. Stroke or death events within 30 days of the index operation occurred in 153 patients (2.0%). Factors independently associated with a higher odds of 30-day stroke or death included the severity of presenting stroke symptoms (cortical transient ischemic attack, odds ratio [OR], 2.17 [95% confidence interval (CI), 1.21-3.90; P = .009]; stroke, OR, 3.30; 95% CI, 2.25-4.85; P .001), advancing age (OR, 1.03 per year; 95% CI, 1.01-1.06; P = .003), and history of unstable angina or myocardial infarction within the past 6 months (OR, 2.20; 95% CI, 1.29-3.77; P = .004), moderate or severe congestive heart failure (OR, 2.44; 95% CI, 1.31-4.55; P = .005), chronic obstructive pulmonary disease (on medications, OR, 1.61 [95% CI, 1.06-2.43; P = .024]; on home oxygen, OR, 2.52 [95% CI, 1.44-4.41; P = .001]), and prior ipsilateral carotid endarterectomy (OR, 1.56; 95% CI, 1.09-2.25; P = .016), whereas preoperative P2YThis Vascular Quality Initiative TCAR risk score calculator can be used to estimate the risk of stroke or death within 30 days of the procedure. Because TCAR is commonly used to treat patients with high surgical risk for carotid endarterectomy, this risk score will help to guide treatment decisions in patients being considered for TCAR.

As the practice of medicine grows in complexity, the process of defining the expertise required for the competent execution of specific procedures has also become complex. The Society for Vascular Surgery therefore constituted a task force to provide informed recommendations on the knowledge, technical skills, resources, and infrastructure required to obtain and to maintain privileges for the safe and effective performance of transcarotid artery revascularization (TCAR). The TCAR procedure is being adopted rapidly, and it is therefore important that informed guidance be available expeditiously. Formal training in the pathophysiology and diagnosis of carotid occlusive disease and all management options is essential. Appropriate diagnostic, imaging, endovascular, surgical, and monitoring infrastructure is required, as are resources to maintain quality control. Credentialing and privileging require a combination of both open surgical and endovascular skills. As such, physicians must have hospital privileges to perform carotid endarterectomy. They should attend an appropriate program for education and simulated training in TCAR. In addition, physicians must have performed ≥25 endovascular procedures as the primary operator using low-profile rapid-exchange platforms plus ≥5 TCAR procedures as the primary operator (pathway 1); or they may have acquired ≥25 endovascular procedures as the primary operator using low-profile rapid-exchange platforms and a supplement of 5 TCAR procedures under proctored guidance if they have not performed sufficient TCAR procedures (pathway 2); or a team of two physicians can collaborate, combining the endovascular and surgical requirements plus at least 5 TCAR procedures under proctored guidance (pathway 3).

Introduction Computer-based video training (CBVT) of surgical skills overcomes limitations of 1:1 instruction. We hypothesized that a self-directed CBVT program could teach novices by dividing basic surgical skills into sequential, easily-mastered steps. Methods We developed a 12 video program teaching basic knot tying and suturing skills introduced in discrete, incremental steps. Students were evaluated pre- and post-course with a self-assessment, a written exam and a skill assessment. Results Students (n = 221) who completed the course demonstrated significant improvement. Their average pre-course product quality score and assessment of technique using standard Global Rating Scale (GRS) were, Graphical abstract Image 1, Highlights • Video based training can teach medical student basic knot tying and suturing skills. • This training is effective despite no faculty involvement. • Students showed marked improvement in technique, speed and the end product. • Remote, computer-based learning may be able to play a larger role in medical education., A computer-based sequential and incremental video training program was effective in teaching 221 pre-clincal medical students basic knot tying and suturing skills surgical skills without faculty involvement. Students demonstrated marked improvement in technique, speed and the end product for a number of skills as assessed by a blinded practical skill exam.

Cytotoxic CD4 T cells are linked to cardiovascular morbidities and accumulate in both human immunodeficiency virus (HIV) and cytomegalovirus (CMV) infections, both of which are associated with increased risk of cardiovascular disease. In this report we identify CMV coinfection as a major driver of the cytotoxic phenotype – characterized by elevated CD57 expression and reduced CD28 expression – in circulating CD4 T cells from people living with HIV infection (PLWH) and investigate potential mechanisms linking this cell population to cardiovascular disease. We find that human CD57+ CD4 T cells express high levels of the costimulatory receptor CD2 and that CD2/LFA-3 costimulation results in a more robust and polyfunctional effector response to T cell receptor (TCR) signals, compared to CD28-mediated costimulation. CD57+ CD4 T cells also express the vascular endothelium-homing receptor CX3CR1 and migrate toward CX3CL1-expressing endothelial cells in vitro. IL-15 promotes the cytotoxic phenotype, elevates CX3CR1 expression, and enhances the trafficking of CD57+ CD4 T cells to endothelium, and may therefore be important in linking these cells to cardiovascular complications. Finally, we demonstrate the presence of activated CD57+ CD4 T cells and expression of CX3CL1 and LFA-3 in atherosclerotic plaque tissues from HIV-uninfected donors. Our findings are consistent with a model in which cytotoxic CD4 T cells contribute to cardiovascular disease in HIV/CMV coinfection and in atherosclerosis via CX3CR1-mediated trafficking and CD2/LFA-3-mediated costimulation. This study identifies several targets for therapeutic interventions and may help bridge the gap in understanding how CMV infection and immunity are linked to increased cardiovascular risk in PLWH.

Recent studies have found that transcarotid artery revascularization (TCAR) is associated with lower risk of stroke or death compared with transfemoral carotid artery stenting but higher risk of bleeding complications, presumably associated with the need for an incision. Heparin anticoagulation is universally used during TCAR, so protamine use may reduce bleeding complications. However, the safety and effectiveness of protamine use in TCAR are unknown. We therefore evaluated the impact of protamine use on perioperative outcomes after TCAR in the Vascular Quality Initiative TCAR Surveillance Project.We performed a retrospective review of patients undergoing TCAR in the Vascular Quality Initiative TCAR Surveillance Project from September 2016 to April 2019. We assessed in-hospital outcomes using propensity score-matched cohorts of patients who did and did not receive protamine. The primary efficacy end point was access site bleeding complications, and the primary safety end point was in-hospital stroke or death. Secondary end points included the individual end points of stroke, death, transient ischemic attack, myocardial infarction, congestive heart failure exacerbation, and hemodynamic instability.Of the 5144 patients undergoing TCAR, all patients received heparin and 4072 (79%) patients received protamine. We identified 944 matched pairs of patients who did and did not receive protamine. Protamine use was associated with a significantly lower risk of bleeding complications (2.8% vs 8.3%; relative risk [RR], 0.33; 95% confidence interval [CI], 0.21-0.52; P .001), including bleeding that resulted in interventional treatment (1.0% vs 3.6%; RR, 0.26; 95% CI, 0.13-0.54; P .001) and in blood transfusion (1.2% vs 3.9%; RR, 0.30; 95% CI, 0.15-0.58; P .001). There were no statistically significant differences in in-hospital stroke or death for patients who received protamine and those who did not (1.6% vs 2.2%; RR, 0.71; 95% CI, 0.37-1.39; P = .32); however, there was a trend toward lower risk of stroke for patients who received protamine (1.1% vs 2.0%; RR, 0.53; 95% CI, 0.24-1.13; P = .09). There were also no statistically significant differences in the rates of transient ischemic attack (0.4% vs 1.1%; RR, 0.40; 95% CI, 0.13-1.28; P = .11), myocardial infarction (0.4% vs 0.8%; RR, 0.50; 95% CI, 0.15-1.66; P = .25), heart failure exacerbation (0.4% vs 0.3%; RR, 1.33; 95% CI, 0.30-5.96; P = .71), or postoperative hypotensive hemodynamic instability (16% vs 15%; RR, 1.06; 95% CI, 0.83-1.35; P = .50) with protamine use.Protamine can be safely used in TCAR to reduce the risk of perioperative bleeding complications without increasing the risk of thrombotic events.

Restenosis after carotid endarterectomy (CEA) poses unique therapeutic challenges, with no specific guidelines available on the operative approach. Traditionally, transfemoral carotid artery stenting (TfCAS) has been regarded as the preferred approach to treating restenosis after CEA. Recently, transcarotid artery revascularization with a flow-reversal neuroprotection system (TCAR) has gained popularity as an effective alternative treatment modality for de novo carotid artery stenosis. The aim of the present study was to compare the contemporary perioperative outcomes of TfCAS and TCAR in patients with prior ipsilateral CEA.The Vascular Quality Initiative database was reviewed for patients who had undergone TfCAS and TCAR for restenosis after prior ipsilateral CEA between January 2016 and August 2020. The primary outcome was the 30-day composite outcome of stroke and death. The secondary outcomes included 30-day stroke, transient ischemic attack (TIA), myocardial infarction (MI), death, and composite 30-day outcomes of stroke, death, and TIA, stroke and TIA, and stroke, death, and MI. Multivariable logistic regression models were used to evaluate the outcomes of interest after adjustment for potential confounders and baseline differences between cohorts.Of 3508 patients, 1834 and 1674 had undergone TfCAS and TCAR, respectively. The TCAR cohort was older (mean age, 71.6 years vs 70.2 years; P .001) and less likely to be symptomatic (27% vs 46%; P .001), with a greater proportion taking aspirin (92% vs 88%; P = .001), a P2Y12 inhibitor (89% vs 80%; P .001), and a statin (91% vs 87%; P = .002) compared with the TfCAS cohort. Perioperatively, the TCAR cohort had had lower 30-day composite outcomes of stroke/death (1.6% vs 2.7%; P = .025), stroke/death/TIA (1.8% vs 3.3%; P = .004), and stroke/death/MI (2.1% vs 3.2%; P = .048), primarily driven by lower rates of stroke (1.3% vs 2.3%; P = .031) and TIA (0.2% vs 0.7%; P = .031). Among asymptomatic patients, the incidence of stroke (0.6% vs 1.4%; P = .042) and the composite of stroke/TIA (0.8% vs 1.8%; P = .036) was significantly lower after TCAR than TfCAS, and TCAR was associated with a lower incidence of TIA (0% vs 1%; P = .038) among symptomatic patients. On adjusted analysis, the TCAR cohort had lower odds of TIA (adjusted odds ratio, 0.17; 95% confidence interval, 0.04-0.74; P = .019).Among patients undergoing carotid revascularization for restenosis after prior ipsilateral CEA, TCAR was associated with decreased odds of 30-day TIA compared with TfCAS. However, the two treatment approaches were similarly safe in terms of the remaining perioperative outcomes, including stroke and death and stroke, death, and MI. Our results support the safety and efficacy of TCAR in this subset of patients deemed at high risk of reintervention.

Objective The decision to perform a one- or two-stage basilic vein transposition (BVT) arteriovenous fistula often depends on factors such as the vessel's diameter, the patient's disposition, and the surgeon's preference. This study's aim was to analyze patency by BVT staging technique and to identify patient-specific characteristics associated with outcomes. Methods A retrospective review of all patients who underwent one- or two-stage BVT at our institution between 2008 and 2013 was performed. Comparisons of age, sex, race, and associated comorbidities were made. Clinical course was followed for 2 years after fistula construction, comparing maturation rate, thrombosis, stenosis, steal, and catheter infections. Continuous variables were expressed as means or medians and compared across stage and maturation groups by t -test; differences between categorical variables were assessed using Fisher exact test. A Kaplan-Meier survival analysis was performed to calculate patency rates and compared by log-rank test. Results There were 49 one-stage and 169 two-stage BVTs examined. The mean age of the patients at time of construction was 58 years and 61 years for one-stage and two-stage patients, respectively. There was no difference in mean proximal, mid, or distal basilic vein diameters between the groups. Fistula maturation was similar between stage groups, with primary failure affecting 26.5% of one-stage and 24.3% of two-stage BVTs ( P = .78). Across one- and two-stage BVTs, 2-year primary patency rates were 51% and 52%, respectively ( P = .68); primary assisted patency, 66% and 85% ( P = .05); and secondary patency, 64% and 78% ( P = .26). Multivariate logistic regression showed a trend toward diabetics at higher risk for primary failure (odds ratio, 1.60; 95% confidence interval, 0.95-2.55; P = .07). For two-stage BVT, the median interstage period between operations lasted 105.00 (interquartile range, 77.00-174.50) days and was associated with a large proportion of the overall primary failures (19/41 [46%]) and catheter-related infections (12/20 [60%]). Conclusions This study demonstrates similar maturation, primary patency, primary assisted patency, secondary patency, and complication rates in a large series of BVTs constructed using a one- or two-stage transposition technique regardless of vein diameter. Diabetes was associated with primary failure by either technique. High proportions of overall primary failures and catheter-related infections observed in two-stage BVT occurred during the interstage, suggesting that a one-stage technique should be considered over a two-stage approach to minimize the risk of catheter infection and to decrease time to maturity.

The decision to intervene for internal carotid stenosis often depends on the degree of stenosis seen on duplex ultrasound (US). The aim of this study is to compare the diagnostic accuracy of two criteria: modified University of Washington (UW) and 2003 Carotid Consensus Panel (CCP). All patients undergoing US in an accredited (IAC) vascular laboratory from January 2010 to June 2015 were reviewed ( n=18,772 US exams). Patients receiving a neck computed tomography angiography (CTA) within 6 months of the US were included in the study ( n=254). The degree of stenosis was determined by UW/CCP criteria and confirmed on CTA images using North American Symptomatic Carotid Endarterectomy Trial (NASCET)/European Carotid Surgery Trial (ECST) schema. Kappa analysis with 95% confidence intervals (CIs) were utilized to determine duplex–CTA agreement. A total of 417 carotid arteries from 221 patients were assessed in this study. The modified UW criteria accurately classified 266 (63.9%, kappa = 0.321, 95% CI 0.255 to 0.386) cases according to NASCET-derived measurements. The sensitivity, specificity, and accuracy at ≥ 60% stenosis were 65.7%, 81.3%, and 81.9%. The CCP criteria resulted in 296 (70.9%) accurate diagnoses (kappa = 0.359, 95% CI 0.280 to 0.437). At ≥ 70% stenosis, the sensitivity, specificity and accuracy were 38.8%, 91.6%, and 87.1% for NASCET. Comparison of the duplex results to ECST-derived CTA measurements revealed a similar trend (UW 53.1%, κ = 0.301 vs CCP 62.1%, κ = 0.315). The CCP criteria demonstrate a higher concordance rate with measurements taken from CTAs. The CCP criteria may be more sensitive in classifying clinically significant degrees of stenosis without a loss in diagnostic accuracy.

On Wednesday, November 1, 2017, the Centers for Medicare and Medicaid Services (CMS) made a public decision to end the transitional pass-through add-on payment for drug-coated balloons beginning January 1, 2018, without creating a new ambulatory payment classification rate for these devices. In this Viewpoint, the authors highlight the disconnect between the CMS's decision not to create a new ambulatory payment classification category for drug-coated balloons despite demonstrated clinical superiority. The authors believe this decision is more in line with a rigid fee-for-service payment system than a value-based system that encourages quality over quantity, and disadvantages both the elderly and the poor. They call on all who advocate for patients with peripheral artery disease to action, encouraging their engagement on CMS decisions regarding payment.

Objective Digital subtraction angiography (DSA) of the peripheral arterial vasculature provides lumenographic information but only a qualitative assessment of blood flow. The ability to quantify adequate tissue perfusion of the lower extremities would enable real-time perfusion assessment during DSA of patients with peripheral arterial disease (PAD). In this study, we used a novel real-time imaging software to delineate tissue perfusion parameters in the foot in PAD patients. Methods Between March 2015 and June 2016, patients (N = 31) underwent lower extremity angiography using a two-dimensional perfusion (2DP) imaging protocol (Philips Healthcare, Andover, Mass). Of the 31 enrolled patients, 16 patients received preintervention and postintervention DSA images (18 angiograms), while contrast agent injection settings and the position of the foot, catheter, and C-arm were kept constant. The region of interest for perfusion measurements was taken at the level of the medial malleolus. Perfusion parameters included arrival time (AT) of contrast material, wash-in rate (WIR), time to peak (TTP) contrast intensity, and area under the curve (AUC). Results Patients (mean age, 67 years; male, 61%) undergoing 2DP had limbs classified as Rutherford class 3 (n = 9 limbs), class 4 (n = 11), and class 5 (n = 14) ischemia with a mean ankle-brachial index of 0.63. For the whole cohort, median (interquartile range) AT measured 5.20 (3.10-7.25) seconds; WIR, 61.95 (43.53-86.43) signal intensity (SI)/s; TTP, 3.80 (2.88-4.50) seconds; peak intensity, 725.00 (613.75-1138.00) SI; and AUC, 12,084.00 (6742.80-17,059.70) SI*s. A subset of patients had 2DP performed before and after intervention (n = 18 cases). A detectable improvement in SI and two-dimensional flow parameters was seen after intervention. Average AT of contrast material to the region of interest shortened after intervention with percentage decrease of 30.1% ± 49.1%, corresponding decrease in TTP of 17.6% ± 24.7%, increase in WIR of 68.8% ± 94.2% and in AUC of 10.5% ± 37.6%, decrease in mean transit time of 18.7% ± 28.1%, and increase in peak of 34.4% ± 42.2%. Conclusions The 2DP imaging allows measurement of blood flow in real time as an adjunct to DSA. The AT may be the most sensitive marker of perfusion change in the lower extremity. Quantitative thresholds based on 2DP hold promise for immediate treatment effectiveness assessment in patients with PAD.

Outcomes from carotid artery stenting (CAS) are related to experience and technical expertise of the operator. Simulation of CAS may enhance clinical proficiency. We interrogated the impact of endovascular simulation of CAS procedures in operators who are at various stages of training.Twelve trainees (students [n = 4]; junior surgery residents, postgraduate year [PGY] 1-3 [n = 4]; and senior surgery residents or fellows, PGY 4-7 [n = 4]) were apprised of characteristics of an endovascular simulator and CAS procedures. This was followed by four independent sessions that were assessed for objective measures including procedure and fluoroscopy times and contrast agent use. A qualitative analysis grading steps of CAS by two observers using a Likert scale was performed. One-way analysis of variance and paired t-tests were employed for data analysis.For all participants (n = 12), procedure times (mean, 920 ± 279 seconds for the first session vs 454 ± 156 seconds for the fourth session; P .01; confidence interval [CI], 315-621) and fluoroscopy cumulative times (mean, 421 ± 230 seconds for the first session vs 222 ± 102 seconds for the fourth session; P .01; CI, 78-285) decreased with progression of cases. Students and PGY 1-3 residents decreased their procedure times significantly in comparison of initial and final sessions (P .05 and P .01, respectively). For all groups, fluoroscopy cumulative times were reduced, and this decrement was significant in the PGY 1-3 cohort (mean, 444 ± 8 seconds for the first session vs 265 ± 51 seconds for the fourth session; P .01; CI, 81-276). Initial CAS procedure times were significantly different between groups (P .05), but this was observed to resolve by the final case at study completion. Qualitatively, the Likert scores of students and PGY 1-3 residents significantly improved with case repetition, specifically in the following steps: (1) cannulation of common carotid artery and (2) sizing and deployment of embolic protection device. Senior operators (PGY 4-7) demonstrated consistently better performance overall with minimal change in scoring with case repetition.Practice leads to improvements in endovascular simulator procedure and fluoroscopy times, especially for more novice trainees. Initial operator performance gaps can be approximated with a few sessions to expected proficiency. Incorporation of endovascular simulators in residency training may assist in shortening the learning curve in rarer endovascular procedures.

Objective Endothelial function is improved by l- arginine ( l- arg) supplementation in preclinical and clinical studies of mildly diseased vasculature; however, endothelial function and responsiveness to l- arg in severely diseased arteries is not known. Our objective was to evaluate the acute effects of catheter-directed l- arg delivery in patients with chronic lower extremity ischemia secondary to peripheral arterial disease. Methods The study enrolled 22 patients (45% male) with peripheral arterial disease (mean age, 62 years) requiring lower extremity angiography. Endothelium-dependent relaxation of patent but atherosclerotic superficial femoral arteries was measured using a combination of intravascular ultrasound (IVUS) imaging and a Doppler FloWire (Volcano Corporation, Rancho Cordova, Calif) during the infusion of incremental acetylcholine (10−6 to 10−4 molar concentration) doses. Patients received 50 mg (n = 3), 100 mg (n = 10), or 500 mg (n = 9) l- arg intra-arterially, followed by repeat endothelium-dependent relaxation measurement (limb volumetric flow). IVUS-derived virtual histology of the culprit vessel was also obtained. Endothelium-independent relaxation was measured using a nitroglycerin infusion. Levels of nitrogen oxides and arginine metabolites were measured by chemiluminescence and mass spectrometry, respectively. Results Patients tolerated limb l- arg infusion well. Serum arginine and ornithine levels increased by 43.6% ± 13.0% and 23.2% ± 10.3%, respectively (P l- arg infusion. Average vessel area increased by 6.8% ± 1.3% with l- arg infusion (acetylcholine 10−4; P l- arg supplementation by 130.9 ± 17.6, 136.9 ± 18.6, and 172.1 ± 24.8 mL/min, respectively, for each cohort. Maximal effects were seen with l- arg at 100 mg (32.8%). Arterial smooth muscle responsiveness to nitroglycerin was intact in all vessels (endothelium-independent relaxation, 137% ± 28% volume flow increase). IVUS-derived virtual histology indicated plaque volume was 14 ± 1.3 mm3/cm, and plaque stratification revealed a predominantly fibrous morphology (46.4%; necrotic core, 28.4%; calcium, 17.4%; fibrolipid, 6.6%). Plaque morphology did not correlate with l- arg responsiveness. Conclusions Despite extensive atherosclerosis, endothelial function in diseased lower extremity human arteries can be enhanced by l- arg infusion secondary to increased nitric oxide bioactivity. Further studies of l- arg as a therapeutic modality in patients with endothelial dysfunction (ie, acute limb ischemia) are warranted.

Transcarotid artery revascularization (TCAR) with the ENROUTE transcarotid neuroprotection and stent system (Silk Road Medical, Inc, Sunnyvale, Calif) combines surgical principles of neuroprotection with less invasive endovascular techniques to treat high grade stenosis in the carotid artery. The ENROUTE Neuroprotection System allows the surgeon to directly access the common carotid artery to initiate high rate temporary blood flow reversal to protect the brain while performing carotid angioplasty and stenting. Unprotected catheterization of the arch and lesion is, thus, avoided. Pivotal data from the Safety and Efficacy Study for Reverse Flow Used During Carotid Artery Stenting Procedure (ROADSTER) study of high-risk patients undergoing TCAR have showed a low stroke rate compared with other prospective trials of endovascular carotid intervention. The aim of this article is to provide specific technical details of TCAR.

Objective Transcarotid artery revascularization (TCAR) has become an increasingly popular alternative for the treatment of carotid bifurcation stenosis. TCAR employs carotid blood flow reversal through an ex vivo common carotid artery to femoral vein shunt for neuroprotection during the placement and angioplasty of the carotid artery stent. There is a lack of data regarding an association between the duration of flow reversal and neurologic complications or other adverse events. We analyzed TCAR flow reversal time in relation to major adverse events. Methods There were 307 patients who underwent TCAR at four high-volume academic institutions. Patients were separated on the basis of the duration of carotid flow reversal as follows: group I, ≤8 minutes (n = 138); group II, 9-13 minutes (n = 105); group III, 14-20 minutes (n = 42); and group IV, >20 minutes (n = 22). Adverse events including stroke (assessed by a National Institute of Health Stroke Scale-certified examiner), myocardial infarction (MI), and death at discharge and 30 days were collected in all patients and were compared between groups using one-way analysis of variance and χ2 analysis. Results There were four strokes in the total cohort, yielding an overall stroke rate of 1.3%. All strokes were minor in nature; two were ipsilateral and two were contralateral. All patients demonstrated full recovery at 30 days. We found no significant difference in the stroke rate between any of the groups: I, 1.5% (2/138); II, 1.9% (2/105); III, 0% (0/42); and IV, 0% (0/22; P = .76). The four strokes occurred in patients with flow reversal time of 6, 7, 11, and 12 minutes. There was also no difference in the 30-day composite stroke/death or stroke/death/MI rates among the groups. Conclusions The length of flow reversal during TCAR does not affect rates of stroke, MI, or death. These data suggest that operators should focus on the technical aspects of the procedure during flow reversal rather than on its duration.