Aortic endograft infection can be eradicated by excision and in situ or extra-anatomic replacement but is often associated with early postoperative morbidity and mortality and occasionally with a need for late removal for reinfection. Prosthetic graft replacement after explanation is associated with higher reinfection and graft-related complications and decreased survival compared with autogenous reconstruction.

Endovascular treatment of chronic total occlusions is often limited by the inability to re-enter the true lumen after subintimal crossing of the occluded segment. This occurs more commonly with treatment of iliac occlusions than in superficial femoral artery occlusions. True lumen re-entry catheters are very effective at gaining wire passage back to the true lumen and facilitating successful endovascular treatment of chronic total occlusions that would otherwise require open bypass.

Compared with patients undergoing TFCAS, patients undergoing TCAR had significantly more medical comorbidities but similar stroke/death rates and half the risk of in-hospital TIA/stroke/death. These results persisted despite rigorous adjustment and matching of potential confounders. This initial evaluation of the VQI TSP demonstrates the ability to rapidly monitor new devices and procedures using the VQI. Although it is preliminary, this is the first study to demonstrate the benefit of TCAR compared with TFCAS in real-world practice. These results need to be confirmed by a clinical trial.

IMPORTANCE Several trials have observed higher rates of perioperative stroke following transfemoral carotid artery stenting compared with carotid endarterectomy. Transcarotid artery revascularization with flow reversal was recently introduced for carotid stenting. This technique was developed to decrease stroke risk seen with the transfemoral approach; however, its outcomes, compared with transfemoral carotid artery stenting, are not well characterized. OBJECTIVE To compare outcomes associated with transcarotid artery revascularization and transfemoral carotid artery stenting. DESIGN, SETTING, AND PARTICIPANTS Exploratory propensity score-matched analysis of prospectively collected data from the Vascular Quality Initiative Transcarotid Artery Surveillance Project and Carotid Stent Registry of asymptomatic and symptomatic patients in the United States and Canada undergoing transcarotid artery revascularization and transfemoral carotid artery stenting for carotid artery stenosis, from September 2016 to April 2019. The final date for follow-up was May 29, 2019. EXPOSURES Transcarotid artery revascularization vs transfemoral carotid artery stenting. MAIN OUTCOMES AND MEASURESOutcomes included a composite end point of in-hospital stroke or death, stroke, death, myocardial infarction, as well as ipsilateral stroke or death at 1 year. In-hospital stroke was defined as ipsilateral or contralateral, cortical or vertebrobasilar, and ischemic or hemorrhagic stroke. Death was all-cause mortality.RESULTS During the study period, 5251 patients underwent transcarotid artery revascularization and 6640 patients underwent transfemoral carotid artery stenting. After matching, 3286 pairs of patients who underwent transcarotid artery revascularization or transfemoral carotid artery stenting were identified (transcarotid approach: mean [SD] age, 71.7 [9.8] years; 35.7% women; transfemoral approach: mean [SD] age, 71.6 [9.3] years; 35.1% women). Transcarotid artery revascularization was associated with a lower risk of in-hospital stroke or death (1.6% vs 3.

Objective: Transcarotid artery revascularization (TCAR) is a novel approach to carotid intervention that uses a direct carotid cut-down approach coupled with cerebral blood flow reversal to minimize embolic potential. The initial positive data with TCAR indicates that it may be an attractive alternative to trans-femoral carotid artery stenting and possibly carotid endarterectomy (CEA) for high-risk patients. The purpose of this study was to present 30-day and 1-year outcomes after treatment by TCAR and to compare these outcomes against a matched control group undergoing CEA at the same institutions.Methods: A retrospective review of all patients who underwent TCAR at four institutions between 2013 and 2017 was performed to evaluate the use of the ENROUTE Transcarotid Neuroprotection System (Silk Road Medical, Inc, Sunnyvale, Calif). TCAR patients had high-risk factors and were either enrolled in prospective trials or treated with a commercially available TCAR device after US Food and Drug Administration approval. Contemporaneous patients undergoing CEA at each institution were also reviewed. Patients were propensity matched in a 1:1 (CEA:TCAR) fashion with respect to preoperative comorbidities. Data were analyzed using statistical models with a P value of less than .05 considered significant. Individual and composite stroke, myocardial infarction, and death at 30 days and 1 year postoperatively were assessed.Results: Consecutive patients undergoing TCAR or CEA were identified (n ¼ 663) and compared. Patients undergoing the TCAR procedure (n ¼ 292) had higher rates of diabetes (P ¼ .01), hyperlipidemia (P ¼ .02), coronary artery disease (P < .01), and renal insufficiency (P < .01) compared with unmatched CEA patients (n ¼ 371). Stroke rates were similar at 30 days (1.0% TCAR vs 1.1% CEA) and 1 year (2.8% TCAR vs 3.0% CEA) in the unmatched groups. After propensity matching by baseline characteristics including gender, age, symptom status (36.3%, 35.3%) and diabetes, 292 TCAR patients were compared with 292 CEA patients. TCAR patients were more likely to be treated preoperative and postoperatively with clopidogrel (preoperatively, 82.2% vs 39.4% [P < .01]; postoperatively, 98.3% vs 36.0% [P < .01]) and statins (preoperatively, 88.0% vs 75.0% [P < .01]; postoperatively, 97.8% vs 78.8% [P < .01]). Stroke (1.0% TCAR vs 0.3% CEA; P ¼ .62) and death (0.3% TCAR vs 0.7% CEA; P ¼ NS) rates were similar at 30 days and comparable at 1 year (stroke, 2.8% vs 2.2% [P ¼ .79]; death 1.8% vs 4.5% [P ¼ .09]). The composite end point of stroke/death/myocardial infarction at 1 month postoperatively was 2.1% vs 1.7% (P ¼ NS). TCAR was associated with a decreased rate of cranial nerve injury (0.3% vs 3.8%; P ¼ .01).Conclusions: These early data suggest that patients undergoing TCAR, even those with high-risk comorbidities, achieve broadly similar outcomes compared with patients undergoing CEA while mitigating cranial nerve injury. Further comparative studies are warranted.

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.

Leg thermotherapy (TT) application reduces blood pressure (BP) and increases both limb blood flow and circulating levels of anti-inflammatory mediators in healthy, young humans and animals. The purpose of the present study was to determine the impact of TT application using a water-circulating garment on leg and systemic hemodynamics and on the concentrations of circulating cytokines and vasoactive mediators in patients with symptomatic peripheral artery disease (PAD). Sixteen patients with PAD and intermittent claudication (age: 63 ± 9 yr) completed three experimental sessions in a randomized order: TT, control intervention, and one exercise testing session. The garment was perfused with 48°C water for 90 min in the TT session and with 33°C water in the control intervention. A subset of 10 patients also underwent a protocol for the measurement of blood flow in the popliteal artery during 90 min of TT using phase-contrast MRI. Compared with the control intervention, TT promoted a significant reduction in systolic (∼11 mmHg) and diastolic (∼6 mmHg) BP (P < 0.05) that persisted for nearly 2 h after the end of the treatment. The serum concentration of endothelin-1 (ET-1) was significantly lower 30 min after exposure to TT (Control: 2.3 ± 0.1 vs. TT: 1.9 ± 0.09 pg/ml, P = 0.026). In addition, TT induced a marked increase in peak blood flow velocity (∼68%), average velocity (∼76%), and average blood flow (∼102%) in the popliteal artery (P < 0.01). These findings indicate that TT is a practical and effective strategy to reduce BP and circulating ET-1 concentration and enhance leg blood flow in patients with PAD.

Hostile neck anatomy remains the predominant reason that patients are denied endovascular aneurysm repair (EVAR). We reviewed our experience of EVAR with use of prophylactic adjunctive proximal balloon-expandable stents in patients with hostile neck anatomy and adjunctive proximal balloon-expandable stents in patients with type I endoleaks. Of 140 patients who underwent EVAR between 2000 and 2004, we reviewed data for 19 patients in whom we used proximal balloon-expandable stents. By high-resolution computed tomography scan or angiography, hostile neck anatomy was classified as length <15 mm, neck diameters > or =26 mm, circumferential thrombus at the proximal neck, angulated neck > or =60 degrees, and neck bulge or reverse taper necks. Patients were considered to have hostile anatomy if they met 1 or more of the above-cited criteria. All patients underwent AAA repair with commercially available endograft systems, Zenith (Cook, Bloomington, IN) and AneuRx (Medtronic/AVE, Minneapolis, MN). Balloon-expandable stents utilized included Cordis-Palmaz stents (17/19) and eV3 Max stents (2/19). Stents were deployed in the proximal graft with transrenal extension. AneuRx (18/19) and Zenith (1/19) endografts were used in all of the patients. Of the 19 patients, 15 had prophylactic stent placement for known hostile neck anatomy and 4 patients had stent placement for type I endoleak. Assisted primary technical success was achieved in all patients. Three patients had maldeployment of the endograft or proximal stent requiring additional endovascular interventions at the time of surgery. No endografts were deployed too low requiring stent placement. Procedure-related complications occurred in 2 of 19 patients. These included 1 operative death secondary to pneumonia and 1 patient who developed progressive renal failure. Short-term clinical success was achieved in 17 of 19 patients. Two patients required secondary interventions, 1 due to device migration with secondary conversion to open repair, and an endoleak, which, on angiogram, was a large type II endoleak successfully treated with coiling of the inferior mesenteric artery. One patient was observed to have a type II endoleak with no associated aneurysm enlargement. Short-term results suggest the use of prophylactic adjunctive balloon-expandable stents may decrease the incidence of secondary interventions related to hostile neck anatomy when used as an adjunctive measure with EVAR. Based on our experience, we feel EVAR may be offered to an expanded patient population with hostile neck anatomy with use of prophylactic balloon-expandable stents.