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Frailty is a clinical syndrome characterized by a reduction in metabolic reserves leading to increased susceptibility to adverse outcomes following invasive surgical interventions. The 5-item modified frailty index (mFI-5) validated in prior studies has shown high predictive accuracy for all surgical specialties, including vascular procedures. In this study, we aim to utilize the mFI-5 to predict outcomes in Transcarotid Revascularization (TCAR).All patients who underwent TCAR from November 2016 to April 2021 in the Vascular Quality Initiative (VQI) Database were included. The mFI-5 was calculated as a cumulative score divided by 5 with 1 point each for poor functional status, presence of diabetes, chronic obstructive pulmonary disease (COPD), congestive heart failure (CHF), and hypertension. Patients were stratified into two groups based on prior studies: low mFI-5 (0.6) and high (≥0.6). Primary outcomes included in-hospital death, extended length of postoperative stay (1 day), and nonhome discharge. Secondary outcomes included in-hospital stroke, transient ischemic attack (TIA), myocardial infarction (MI), a composite endpoint of stroke/death, stroke/TIA, and stroke/death/MI. Univariate and multivariable logistic regression were used to assess the association between mFI-5 and postoperative outcomes. Secondary analysis stratified by symptomatic status was performed.Out of the 17,983 patients who underwent TCAR, 4526(25.2%) had mFI-5 score of ≥0.6 and considered clinically frail. Compared to the nonfrail group, frail patients were more likely to be female (38.7% vs. 35.6%, P 0.001), have poor functional status (43.6 vs. 8.3%, P 0.001), and present with significant comorbidities, including diabetes (75.3% vs. 26.1%, P 0.001), hypertension (98.9% vs. 88.5%, P 0.001), CHF (52.2% vs. 5.6, P 0.001), and COPD (60.3% vs. 14.2%, P 0.001). They were also more likely to be active smokers (25.4% vs. 20.4%, P 0.001) and symptomatic prior to intervention (28.7% vs. 25.3%, P 0.001). On univariate analysis, frail patients were at significantly higher risk to experience adverse outcomes, including in-hospital mortality, TIA, MI, stroke/death, stroke/TIA, stroke/death/MI, discharge to nonhome facility, and extended LOS. After adjusting for potential confounders, frail patients remained at significantly higher risk of in-hospital mortality [aOR 2.26(1.41,3.61), P = 0.001], TIA [aOR 1.65(1.08, 2.54), P = 0.040], nonhome discharge [aOR 1.99(1.71,2.32) P 0.001], and extended LOS [aOR 1.41(1.27, 1.55) P 0.001]. On further stratified analysis based on symptomatic status, the increased risk of stroke/death, TIA, and death was observed only in symptomatic patients.Modified Frailty Index is a reliable tool that can be used to identify high-risk patients for TCAR prior to intervention. This could help vascular surgeons, patients, and families in informed decision making to further optimize perioperative care and medical management in frail patients.

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

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.

Objective The optimal antiplatelet regimen after lower extremity revascularization in patients with chronic limb-threatening ischemia (CLTI) is unknown because current recommendations are based on extrapolation of data from trials in coronary artery disease and stroke. Methods We identified all patients undergoing an elective lower extremity revascularization for CLTI in the Vascular Quality Initiative registry discharged on a mono antiplatelet agent (MAPT) or dual antiplatelet therapy (DAPT). Results From 2003 to 2018, 50,890 patients underwent revascularization procedures for CLTI, and were discharged on MAPT or DAPT. Of these, 33,781 patients underwent endovascular therapy (EVT), and 17,109 patients underwent open surgery (OS) procedures. The rate of major amputation at 30 days in the target limb in the EVT group was 0.3% and 0.4% in the OS group (P = .22). On Kaplan-Meier analyses, patients on MAPT at discharge had a higher risk of 1-year major amputation compared with DAPT after EVT but not after OS procedures. Patients on MAPT had lower overall survival and amputation-free survival at 30 days and 1 year compared with DAPT after both EVT and OS. At 1 year, the MAPT group was at higher risk for target lesion reintervention after EVT compared with the DAPT group (15.9% vs 13%; P = .0012). There was no significant difference in thrombosis at 1 year between the MAPT and DAPT groups either after EVT (3.9% vs 3.7%; P = .3048) or OS (3.1% vs 3.2%; P = .2893). On Cox regression analysis, DAPT was associated with improved survival but not major amputation after both EVT and OS. Conclusions In patients with CLTI, DAPT at the time of discharge has a positive impact on amputation-free survival and overall survival after both EVT and OS as well as target lesion reintervention after EVT. DAPT was not associated with a positive impact on major amputation after either EVT or OS.

Hemostatic agents are routinely used in vascular surgery to complement proper suture techniques and decrease the risk of perioperative bleeding. A relative lack of comparative research studies have left surgeons with the option of choosing hemostatic agents based on their personal experience. The present review has highlighted the efficacy and safety of hemostatic agents and categorized them according to their primary mechanism of action and cost.A systematic search strategy encompassing hemostatic agent products was deployed in the PubMed database. Single-center and multicenter, randomized, controlled trials with10 patients were included in the present study.We reviewed 12 studies on the efficacy and safety of hemostatic agents compared with manual compression or other hemostatic agents. Using the time to hemostasis as the primary end point, all studies had found hemostatic agents to be significantly more efficient than manual compression. Likewise, adhesives (high pressure sealants) and dual agents (containing biologically active and absorbable components) were found to be more efficient, but costlier, than agents with either biologically active or absorbable components only. Agents with porcine or bovine constituents were found to trigger anaphylactic reactions in rare cases. Additionally, the absence of fibrin stabilizing factor XIII in a brand of fibrin sealant was speculated to reduce the affinity of the fibrin sealant for the expanded polytetrafluoroethylene graft. The cost of agents varied greatly depending on their active ingredient.Hemostatic agents appear to be highly effective at decreasing the risk of bleeding during surgical procedures. Although some hemostatic agents were demonstrated to achieve hemostasis faster than others, most are able to control bleeding within 10 minutes. Based on the limited data, the least expensive agents might suffice for limited suture lines used in routine procedures.

OBJECTIVE. No studies or guidelines exist to direct management of ureteroarterial fistula (UAF) after ileal conduit urinary diversion in which the possible risks and complications associated with stent-graft infection from the conduit flora must be reconciled with those of open surgical repair. This study seeks to characterize the clinical presentation, pathogenesis, and optimal diagnostic and therapeutic management of this entity through a systematic review of the literature. MATERIALS AND METHODS. A systematic search of the English-language literature using the PubMed, Scopus, and ScienceDirect databases was performed: 264 abstracts were identified. From those abstracts, 32 studies comprising 40 patients with 43 UAFs were selected for analysis. Data points including demographics, clinical presentation, UAF specifications, procedural details, postprocedural complications, and clinical outcomes were reviewed. RESULTS. Predisposing factors included female sex, chronic ureteral stent placement, and past surgical intervention and irradiation for pelvic malignancy. Fistulization was overwhelmingly unilateral (95.0% of patients) and included the common iliac artery (90.7% of UAFs). Combined endovascular and endoureteral modalities presented similar outcomes compared with surgical approaches in terms of UAF-related mortality (7.1% vs 13.3%, respectively) and complication rates (28.6% vs 26.7%) during a similar median follow-up period (9.5 vs 14.0 months). Endovascular stent-graft infections were present in 14.3% of cases and represented a leading indication for reintervention after endovascular management (50.0%). CONCLUSION. Short- and intermediate-term outcomes of combined endovascular and endoureteral techniques compare favorably with those of surgical approaches in the treatment of UAF after ileal conduit urinary diversion. Although there is a relatively low stent-graft infection rate, close follow-up within the first year after the procedure is required given the propensity of complications to develop during this window. The use of postprocedural antibiotics is uncertain but is likely prudent.

There is no consensus on the optimal antiplatelet and anticoagulant regimen for patients following lower extremity bypass. Commonly, patients who receive below the knee bypasses are initiated on oral anticoagulation therapy, which historically has been with prosthetic conduits and utilizing warfarin. However, the use of direct oral anticoagulants (DOACs) is increasing due to their relative ease of dosing. The goal of this study is to evaluate whether a difference exists in post-operative outcomes for patients undergoing infra-geniculate bypass, who are placed on DOACs versus warfarin.The Vascular Quality Initiative infra-inguinal bypass database was queried for all patients who underwent an infra-geniculate bypass, were anticoagulation-naïve at baseline, but were discharged on anticoagulation. A survival analysis was performed for patients up to two years to determine whether being discharged on warfarin versus DOACs was associated with differences in overall mortality, loss of 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.During the study period (2007-2020) 57,887 patients underwent infra-geniculate bypass. Of these patients, 2,786 were anticoagulation naïve and discharged on either warfarin (n=1,889) or DOACs (n=897). Being discharged on a DOACs was associated with lower risk of overall mortality (HR 0.62, CI 0.47 - 0.83, p = 0.001), loss of primary patency (HR 0.74, CI 0.62 - 0.87 p0.001), risk of amputation (HR 0.70, CI 0.57 - 0.86, p = 0.001), and risk of MALE (HR 0.83, CI 0.71 - 0.97, p = 0.017).Anticoagulation-naïve patients who underwent an infra-geniculate bypass had higher rates of overall survival, bypass patency, amputation free survival, and freedom from MALE when discharged on a DOAC compared to warfarin.

Objective Patients may be considered at high risk for CEA due to either anatomical or physiologic factors and are often treated with TCAR. Patients with physiologic criteria are deemed to have higher overall surgical risk due to more significant comorbidities. Our aim is to study the incidence of stroke, myocardial infarction (MI), death, and combined endpoints in patients who underwent TCAR comparing ANAT vs. PHYS risk factors. Methods An analysis of the prospectively collected data from the ROADSTER (pivotal), ROADSTER2 (FDA indicated post-market), and ROADSTER Extended Access TCAR trials was performed. All patients (n=851) were considered to be at high risk for CEA and were included and stratified based on high risk ANAT criteria (contralateral occlusion, tandem stenosis, high cervical artery stenosis, restenosis after previous endarterectomy, bilateral carotid stent, hostile neck with previous neck irradiation, neck dissection, or cervical spine immobility) or high-risk PHYS criteria (age75 years, multi-vessel coronary artery disease, history of angina, congestive heart failure NYHA class III/IV, left ventricular ejection fraction30%, recent MI, severe chronic obstructive pulmonary disease (COPD), permanent contralateral cranial nerve injury, or chronic renal insufficiency). For trial inclusion, asymptomatic patients had80% carotid stenosis and symptomatic patients had50% stenosis. Primary outcome measures were stroke, death, and MI at 30 days. Data was statistically analyzed with the χ2 test as appropriate. Results There were 851 high surgical risk patients categorized into ANAT only risk factors (n = 372) or having at least one PHYS risk factor (n = 479). The ANAT subset had 74.5% asymptomatic patients, while the PHYS subset had 76.6%. General anesthesia was employed similarly in both groups (67.7% ANAT vs. 68.1% PHYS). MI occurred in 8 PHYS (1.7%) patients all of whom were asymptomatic and in no ANAT patients (p = .01). Combined stroke, death, and MI rate was 2.1% in the ANAT cohort, compared to 4.2% in the PHYS cohort (p = .10). Stratification of each group into asymptomatic and symptomatic patients did not yield any further differences. Conclusion Patients who underwent TCAR in this prospective, neurologically adjudicated trial based on high-risk PHYS factors had higher rates of MI compared to patients who qualified with ANAT criteria only. These patients experienced comparable rates of combined stroke/death/MI rates. ANAT patients represent a healthier and younger subset of patients, with notably low overall event rates.

ImportanceCarotid artery stenting has been limited to use in patients with high surgical risk; outcomes in patients with standard surgical risk are not well known.ObjectiveTo compare stroke, death, and myocardial infarction outcomes following transcarotid artery revascularization vs carotid endarterectomy in patients with standard surgical risk.Design, Setting, and ParticipantsThis 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.ExposuresTranscarotid artery revascularization vs carotid endarterectomy.Main Outcomes and MeasuresThe primary outcome was a composite end point of 30-day stroke, death, or myocardial infarction or 1-year ipsilateral stroke.ResultsAfter 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 RelevanceIn 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.

Paclitaxel-coated devices have been shown to decrease restenosis when used in the femoropopliteal artery. Recent reports have suggested a possible risk of increased late mortality in patients treated with paclitaxel. It has been suggested that younger patients and those with limited comorbidities may be at higher risk. Our objective was to analyze long-term mortality based on patient age comparing treatment with paclitaxel to uncoated devices.We performed a retrospective review of 1,170 consecutive patients who underwent femoropopliteal percutaneous intervention by angioplasty, atherectomy, stent placement, or combination between 2011 and 2018. Patients were grouped by age at the time of procedure:60 years old (n = 244, 20.9%), 60-80 years old (n = 635, 54.3%), and80 years old (n = 291, 24.9%). Within each group, patients were further divided by use of paclitaxel. The primary outcome measure was survival assessed by Kaplan-Meier analysis. Differences between the groups were analyzed with analysis of variance. Multivariable analysis was performed using Cox proportional hazard models.Of the 1,170 patients who underwent femoropopliteal percutaneous intervention, 654 (55.9%) received a paclitaxel-coated device during treatment and 516 (44.1%) did not. Mean age of the overall patient cohort was 70.4 ± 12.6 years and 663 (56.7%) were male. When comparing the groups by age we found an increase in age but a decrease in the proportion of patients who smoke. The use of paclitaxel-coated devices was similar across the groups (60 years old, 56.2%; 60-80 years old, 57.0%;80 years old, 52.6%; P = 0.45). Demographics and comorbidities were similar between the patients treated with and without paclitaxel within each age group except more males in the60-year-old group treated without paclitaxel and more patients with chronic limb threatening ischemia in the80-year-old group treated with paclitaxel. In patients60 and 60-80 years old paclitaxel use was associated with increased survival at 4 years:60 (80.7% vs. 64.4%; P = 0.04); 60-80 (63.2% vs. 55.1%; P = 0.04). Survival was similar in the80-year-old group (46.6% vs. 32.8%; P = 0.65).Our data suggest that the use of paclitaxel-coated arterial devices is not associated with increased mortality. On the contrary, our data show that younger patients treated with paclitaxel show improved survival compared with those treated without paclitaxel. Paclitaxel-coated devices may be used with continued caution especially in patients at high risk for restenosis.

Background: First-generation drug-coated balloons (DCBs) have significantly reduced the rate of restenosis compared with balloon angioplasty alone; however, high rates of bailout stenting and dissections persist. The Chocolate Touch DCB is a nitinol constrained balloon designed to reduce acute vessel trauma and inhibit neointima formation and restenosis. Methods: Patients with claudication or ischemic rest pain (Rutherford class 2–4) and superficial femoral or popliteal disease (≥70% stenosis) were randomized 1:1 to Chocolate Touch or Lutonix DCB at 34 sites in the United States, Europe, and New Zealand. The primary efficacy end point was DCB success, defined as primary patency at 12 months (peak systolic velocity ratio Results: A total of 313 patients were randomized to Chocolate Touch (n=152) versus Lutonix DCB (n=161). Follow-up at 1 year was available in 94% of patients. The mean age was 69.4±9.5 years, the average lesion length was 78.1±46.9 mm, and 46.2% had moderate-to-severe calcification. The primary efficacy rates of DCB success at 12 months was 78.8% (108/137) with Chocolate Touch and 67.7% (88/130) with Lutonix DCB (difference, 11.1% [95% CI, 0.6–21.7]), meeting noninferiority ( P noninferiority P superiority =0.04). The primary safety event rate was 88.9% (128/144) with Chocolate Touch and 84.6% (126/149) with Lutonix DCB ( P noninferiority P superiority =0.27). Conclusions: In this prospective, multicenter, randomized trial, the second-generation Chocolate Touch DCB met both noninferiority end points for efficacy and safety and was more effective than Lutonix DCB at 12 months for the treatment of femoropopliteal disease. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02924857.

Objective Three procedures are currently available to treat atherosclerotic carotid artery stenosis: carotid endarterectomy (CEA), transfemoral carotid artery stenting (TF-CAS), and transcarotid artery revascularization (TCAR). Although there is considerable debate evaluating each of these in a head-to-head comparison to determine superiority, little has been mentioned concerning the specific anatomic criteria that make one more appropriate. We conducted a study to define anatomic criteria in relation to inclusion and exclusion criteria and relative contraindications. Methods A retrospective review was conducted of 448 carotid arteries from 224 consecutive patients who underwent a neck and head computed tomography arteriography (CTA) scan before carotid intervention for significant carotid artery stenosis. Occlusion of the internal carotid artery (ICA) occurred in 15, yielding 433 arteries for analysis. Anatomic data were collected from CTA images and demographic and comorbidities from chart review. Eligibility for CEA, TF-CAS, and TCAR was defined on the basis of anatomy, not by comorbidity. Results CTA analysis revealed that 92 of 433 arteries (21%) were ineligible for CEA because of carotid lesions extending cephalad to the second cervical vertebra. Overall, 26 arteries (6.0%) were not eligible for any type of carotid artery stent because of small ICA diameter (n = 11), heavy circumferential calcium (n = 14), or combination (n = 1). An additional 126 arteries were ineligible for TF-CAS on the basis of a hostile aortic arch (n = 115) or severe distal ICA tortuosity (n = 11), yielding 281 arteries (64.9%) that were eligible. In addition to the 26 arteries ineligible for any carotid stent, TCAR was contraindicated in 39 because of a clavicle to bifurcation distance Conclusions A significant proportion of patients who present with carotid artery stenosis have anatomy that makes one or more carotid interventions contraindicated or less desirable. Anatomic factors should play a key role in selecting the most appropriate procedure to treat carotid artery stenosis. Determination of superiority for one procedure over another should be tempered until anatomic criteria have been assessed to select the best procedural options for each patient.

Objective Long-term safety concerns have been raised that the use of paclitaxel-coated balloons and stents is linked to excess mortality. Our objective was to compare outcomes in patients treated with paclitaxel vs uncoated devices and to analyze long-term mortality. Methods We conducted a retrospective single-institution review of 1170 consecutive patients who underwent femoropopliteal percutaneous revascularization by angioplasty, atherectomy, stent placement, or combination between 2011 and 2018. The primary outcome measure was all-cause mortality. Groups were divided into patients who received paclitaxel (n = 652) and those who did not (n = 518). Categorical variables were assessed using χ2 analysis and continuous variables with the Wilcoxon signed rank test. A multivariable analysis was performed using multivariable logistic regression models. Mortality was compared using Kaplan-Meier survival analysis. Results Demographics, risk factors, and Rutherford class were similar between the groups, except that the paclitaxel group was more likely to have diabetes (60.9% vs 55.0%; P = .04), was less likely to be on dialysis (10.7% vs 14.9%; P = .04), and had lower average creatinine concentration (1.6 ± 1.8 mg/dL vs 2.0 ± 2.3 mg/dL; P = .003). There were no differences in all-cause mortality through 2 years between paclitaxel and no-paclitaxel cohorts (25.5% vs 30.3%; log-rank, P = .098). At 3 years and 3.5 years, mortality was significantly lower in the paclitaxel group: year 3, 32.1% vs 39.4% (log-rank, P = .041); year 3.5, 35.2% vs 43.9% (log-rank, P = .027). Survival rates were not significantly different in examining subgroups by diabetes, chronic kidney disease, presence of chronic limb-threatening ischemia, or paclitaxel-coated balloon manufacturer. Multivariable analysis demonstrated that age, dialysis, chronic limb-threatening ischemia, chronic kidney disease, and congestive heart failure were independent risk factors for mortality, whereas paclitaxel use was associated with lower mortality. Conclusions The use of paclitaxel-coated balloons and stents does not increase mortality compared with uncoated devices out to 3.5 years. Paclitaxel-coated devices can be used with continued caution, especially in patients at increased risk of restenosis. Further long-term studies are needed to determine the risk of late mortality.

Objective The incidence of perigraft hygroma (PGH) development after aortic reconstruction remains poorly defined and its clinical relevance is questionable. This study was designed to establish the incidence of and determine the risk factors associated with PGH formation and its outcomes. Methods Patients who underwent open aortic reconstruction for either aneurysmal or occlusive disease with an expanded polytetrafluoroethylene (ePTFE) or polyester graft from 2004 to 2018 were retrospectively reviewed (n = 262). Only those who had follow-up imaging 3 or more months after repair were included. Patients with mixed graft types were excluded. PGH was defined as a perigraft fluid collection of 30 mm or greater in diameter with a radiodensity of 30 or fewer Hounsfield units on computed tomography at a minimum of 3 postoperative months. Analysis was conducted between patients with and without PGH. Results One hundred forty patients met the inclusion criteria: 88 were treated with ePTFE and 52 with polyester grafts. Twenty-three patients (16.4%) were found to have radiologic evidence of PGH. PGH developed more frequently in patients with ePTFE (21/88 [23.9%]) compared with those with polyester grafts (2/52 [3.8%]) (P = .002). Mean PGH size was 63.5 ± 36.4 mm (range, 33-153 mm) and the average time to PGH detection 27.7 months (range, 3-112 months). Baseline characteristics were similar between the groups. Patients who developed PGH had larger aneurysms, more often received ePTFE grafts, had larger graft diameters, and had bifurcated grafts. The overall mortality was 32.1% at a mean follow-up of 5.2 years. The 5-year mortality rates were similar between patients with and without PGH (26.1% vs 18.8%; P = .41). Of the 23 patients with PGH, 4 (all with ePTFE) presented with symptoms related to the PGH. The average size of symptomatic and asymptomatic PGH were 11.5 and 4.8 cm, respectively. Mortality rates overall were similar between those with and without symptoms (50.0% vs 36.8%; P = .99). Conclusions Nearly one-quarter of aortic reconstructions with ePTFE are associated with PGH formation compared with 4% with polyester. Clinically significant PGH-related symptom development occurs in 20%. Patient education and close surveillance are warranted. Manufacturer's device modification is needed.

These Society for Vascular Surgery Clinical Practice Guidelines describe the care of patients with aneurysms of the visceral arteries. They include evidence-based size thresholds for repair of aneurysms of the renal arteries, splenic artery, celiac artery, and hepatic artery, among others. Specific open surgical and endovascular repair strategies are also discussed. They also describe specific circumstances in which aneurysms may be repaired at smaller sizes than these size thresholds, including in women of childbearing age and false aneurysms. These Guidelines offer important recommendations for the care of patients with aneurysms of the visceral arteries and long-awaited guidance for clinicians who treat these patients.

The neutrophil-lymphocyte ratio (NLR) is an inexpensive and useful inflammatory marker that incorporates the balance of the innate (neutrophil) and adaptive (lymphocyte) immune responses. Data exist on the association between NLR and mortality in various coronary diseases and in cancer surgery, but there is a paucity of data on the impact of preoperative NLR on vascular surgical outcomes. The aim of this study was to evaluate the relationship between preoperative NLR and elective endovascular aortic aneurysm repair (EVAR) outcome.A retrospective review of all patients who underwent elective EVAR at a single institution between 2010 and 2018 was conducted (n = 373). Only patients who had a preoperative complete blood count with differential within 30 days of their operation were included. The NLR was computed by dividing the absolute neutrophil count by the absolute lymphocyte count. A receiver operating characteristic curve was used to determine the optimal cutoff value of NLR with the strongest association with mortality. NLR was dichotomized so that patients with NLR above the threshold were at increased risk of mortality compared with those below it. Continuous variables were analyzed using Wilcoxon nonparametric signed-rank test and categorical variables with the Fisher exact test. A comparison of NLR and mortality was completed using Kaplan-Meier survival analysis. Cox regression analysis was used to evaluate factors associated with mortality through 5-year follow-up.Overall, 108 patients were included in this study. An NLR ≥ 4.0 was found to be associated with mortality (P .0001). Thirty-two patients composed the High-NLR (NLR ≥ 4.0) group and the remaining 76 patients formed the Low-NLR (NLR 4.0) group. Baseline characteristics were similar between groups, except that the High-NLR group was older (77.9 vs 74.4; P = .047). At a mean of 36.4 months follow-up, the overall mortality rate was 32.4%. Although there were no differences in the perioperative period, the Kaplan-Meier estimates of mortality were significantly greater in the High-NLR group at 1, 2, and 5 years postoperatively (P .0001). The mean preoperative NLR of the deceased was higher (5.94 ± 5.20; median, 4.75; interquartile range, 3.17-7.83) than those who survived (2.87 ± 1.61; median, 2.53; interquartile range, 1.97-3.49) (P .0001). Secondary interventions and sac enlargement rates were similar between groups. On univariable analysis, NLR (hazard ratio [HR], 1.17; 95% confidence interval [CI], 1.10-1.23; P .0001), age (HR, 1.06; 95% CI, 1.02-1.11; P = .004), and aneurysm diameter (HR, 1.04; 95% CI, 1.01-1.07; P = .003) were associated with mortality. On multivariable analysis, NLR (HR, 1.19; 95% CI, 1.12-1.27; P .0001), age (HR, 1.06; 95% CI, 1.01-1.11; P = .026), and aneurysm diameter (HR, 1.04; 95% CI, 1.02-1.07; P = .003) were associated with mortality.Patients with an elevated preoperative NLR, irrespective of other comorbidities, may represent a previously unrecognized subset of patients who are at heightened risk of mortality after elective EVAR. A complete blood count with differential is an inexpensive test that may be used as a prognostic indicator for outcome after EVAR. Further research is warranted to identify clinical, pathological, or anatomical factors associated with an elevated NLR and to determine modifiable factors, which may help improve long-term survival.

Purpose: To present the 6-month results of the Stromal Cell–Derived Factor-1 Plasmid Treatment for Patients with Peripheral Artery Disease (STOP-PAD) trial. The trial was an attempt to alter the course of chronic limb-threatening ischemia (CLTI) with a biological agent vs placebo after successful arterial revascularization at or below the knee. Materials and Methods: The multicenter, randomized, double-blinded, placebo-controlled, phase 2B STOP-PAD trial ( ClinicalTrials.gov identifier NCT02544204) randomized 109 patients (mean age 71 years; 68 men) with Rutherford category 5 or 6 CLTI and evidence of persistent impaired forefoot perfusion following recent successful revascularization to 8- (n=34) or 16-mg (n=36) intramuscular injections of a non-viral DNA plasmid–based treatment vs placebo (n=34). The primary efficacy outcome was the 6-month wound healing score evaluated by an independent wound core laboratory; the primary safety endpoint was major adverse limb events (MALE), a composite of major amputation plus clinically-driven target lesion revascularization at 6 months. Results: Only one-third of the patients had complete wound healing at 6 months in the placebo (31%), 8-mg injection (33%), and 16-mg injection (33%) groups. In addition, the observed increase in the toe-brachial index from baseline to 6 months was statistically significant in each group; however, this did not result in lower rates of MALE at 6 months (24% in the placebo, 29% in the 8-mg injection, and 11% in the 16-mg injection groups). During the 6-month period, 6 patients (6%) died, and 24 patients (23%) had an amputation [only 4 (4%) major]. Conclusion: Combining revascularization and biological therapy failed to improve outcomes in CLTI at 6 months. STOP-PAD has provided insights for future trials to evaluate biological therapy.

Objective: Transcarotid artery revascularization (TCAR) using the ENROUTE Neuroprotection System (Silk Road Medical) is a United States Food and Drug Administration–approved treatment modality for stroke risk reduction in the setting of carotid artery stenosis. The goal of this investigation was to define the real-world outcomes associated with the application of this technique to patients presenting with restenosis after previous carotid endarterectomy (CEA) or transfemoral carotid artery stenting (TF-CAS). Methods: Retrospective review of prospectively maintained institutional databases capturing all nontrial TCARs performed between August 2013 and July 2018 using the ENROUTE Neuroprotection System was completed at 3 unaffiliated hospital systems and unified for descriptive outcomes analysis. Results: During the study period, 237 combined TCARs were performed at our respective institutions. Of these procedures, 55 stents were implanted for the indication of restenosis after previous carotid revascularization (47 CEA, 8 TF-CAS). Within the 30-day perioperative period, we observed no ipsilateral strokes or deaths; one patient experienced perioperative myocardial infarction (MI; 1.8%). We noted a 4.8% incidence of postoperative hematoma, but none of these events were clinically significant as no reinterventions were performed in any of the 55 patients. Additionally, we did not observe any cases of stent thrombosis or pulmonary embolus. Mean length of stay was 2.2 ± 2.8 days. Our mean follow-up duration was 15.0 ± 9.2 months. Throughout the follow-up period, we did not observe any additional stroke or MI events. Additionally, there were no cases of in-stent restenosis, thrombosis, or reinterventions. Conclusion: Transcarotid artery revascularization can be performed in patients with restenotic carotid arteries with acceptable rates of ipsilateral stroke, MI, and death as demonstrated in this small multi-institutional series.

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.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.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.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.

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.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.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).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.

An elevated neutrophil-lymphocyte ratio (NLR) is a biomarker associated with adverse outcomes after cardiovascular surgery. This study evaluates the association of preoperative NLR with clinical outcomes after peripheral vascular intervention (PVI) of the femoropopliteal segments.A retrospective review identified 488 patients who underwent percutaneous interventions of femoropopliteal arteries between 2011 and 2018 and had a pre-procedural complete blood count with differential with normal white blood cell count within 30 days prior to intervention. Amputation-free survival (AFS), survival, and freedom from major amputation were assessed using Kaplan-Meier methods. Cohorts of patients with NLR3 (Low), 3-4 (Mid), and4 (High) were compared using univariate and multivariable statistical models. In these analyses NLR was analyzed as a continuous variable to correlate with clinical outcomes.Mean age was 71.7±12.8 years and males constituted 55.5%. The majority of patients presented with chronic limb threatening ischemia (CLTI, 78.5%). Increasing NLR was correlated with increasing rates of comorbidities, except for smoking history. The 30-day mortality rates increased with increasing NLR: 1.4%, 4.3%, and 7.0% for low (3), mid (3-4) and high (4) NLR groups, respectively (P=0.005). Patients with a lower pre-operative NLR achieved significantly greater amputation-free survival at 4-year follow-up: low NLR, 65.5%; mid NLR, 37.5%; and high NLR, 17.6% (P0.0001). By multivariable analysis, increasing NLR, advanced age, CLTI, and dialysis-dependent renal failure reduced AFS.Elevated NLR is an independent predictor of decreased AFS following percutaneous interventions of femoropopliteal segments. Further research on identification and modulation of risk factors for high NLR are warranted.

Completion cerebral angiography (CCA) after transcarotid artery revascularization (TCAR) has been used to identify distal embolization after stenting and serve as a measure of intraoperative quality control. Nevertheless, no general evidence has been reported regarding the benefit of performing routine CCA. The aim of the present study was to evaluate the potential risks and benefits of routine CCA.We retrospectively reviewed the Vascular Quality Initiative database for TCAR from 2016 to 2021. The patients were divided into two groups: those with no CCA performed and those with CCA performed. The primary outcome was in-hospital stroke or death. The secondary outcomes included stroke, death, myocardial infarction, and a return to the operating room (RTOR). Clinically relevant and statistically significantly variables on univariable analysis were added to a logistic regression model clustered by center identifier.A total of 18,155 patients who had undergone TCAR were identified, of whom 11,607 (63.7%) had undergone routine CCA. The patients with routine CCA were more likely to have contralateral carotid occlusion and to have received general anesthesia. After adjusting for potential confounders, we found no differences in the risk of stroke/death (adjusted odds ratio [aOR], 1.03; 95% confidence interval [CI], 0.8-1.3; P = .820), stroke/transient ischemic attack (TIA; aOR, 1.00; 95% CI, 0.8-1.3; P = .998), stroke (aOR, 1.1; 95% CI, 0.8-1.4; P = .452), death (aOR, 0.98; 95% CI, 0.6-1.6; P = .953), myocardial infarction (aOR, 0.78; 95% CI, 0.5-1.2; P = .240), or RTOR (aOR, 1.5; 95% CI, 0.6-3.8; P = .412) between patients who had undergone CCA and those who had not. A subanalysis of the patients with new occlusions detected by CCA (69 patients [0.6%]; 19 not treated and 50 treated) indicated a higher risk of stroke/death for the patients with treated new occlusions (aOR, 7.1; 95% CI, 2.9-17.3; P .001) and stroke/TIA (aOR, 5.8; 95% CI, 2.3-14.7; P .001) than for the patients who had not undergone CCA. However, no differences were found in stroke/death (aOR, 3.3; 95% CI, 0.37-29.5; P = .283) or stroke/TIA (aOR, 3.1; 95% CI, 0.3-29.4; P = .327) for patients with nontreated new occlusions compared with patients who had not undergone CCA.In the present retrospective study, routine performance of CCA was not beneficial, with no significant differences in in-hospital stroke or death detected. The detection of new lesions on CCA was rare. Moreover, identifying new occlusions using CCA was associated with higher odds of stroke or death when these new lesions were treated. Further studies are needed to define the etiology of the worse outcomes for patients undergoing intervention for lesions discovered using CCA and delineate the optimal timing for further imaging and intervention.

OBJECTIVES To assess geriatric nutritional risk index (GNRI) in patients with chronic limb-threatening ischemia (CLTI). BACKGROUND The prevalence of CLTI continues to rise, with major amputation and mortality remaining prominent. Frailty is a vital risk factor for adverse outcomes in cardiovascular care. The GNRI is a nutrition-based surrogate for frailty that has been utilized in Southeast Asia to predict adverse events in CLTI. It has not yet been evaluated in a primarily Western population, nor in the context of wound healing. METHODS Between 8August 2017 and April 2019, we identified patients undergoing endovascular interventions for CLTI at our institution, categorized into low GNRI (≤ 94, frail) versus normal GNRI (> 94, reference). We analyzed the risks of major adverse limb events (MALE), its individual components [mortality, major amputation, and target vessel revascularization (TVR)], amputation free survival (AFS), and wound healing using Kaplan-Meier and multivariate cox-proportional hazard regression analyses. RESULTS A total of 255 patients were included in the analysis, with follow up of 14 ± 9.1 months. Lower GNRI was associated with higher cumulative event rates for MALE (71.0% vs. 43.3%, p < 0.001), mortality (34.3% vs. 15.2%, p

With the expanding application of endovascular technology, the need to deploy into zone 0 has been encountered on occasion. In the present study, we evaluated the outcomes of great vessel debranching (GVD) as a method of extending the proximal landing zone to facilitate thoracic endovascular aortic repair (TEVAR).We performed a single-center retrospective review of all patients who had undergone GVD followed by TEVAR between May 2013 and December 2020. The primary outcome was primary patency of all targeted vessels, with all-cause perioperative mortality as a secondary outcome. Kaplan-Meier analysis was used to account for censoring of mortality and primary patency. The extent of hybrid aortic repairs was characterized into type I (GVD plus TEVAR without ascending aorta or aortic arch reconstruction, type II (GVD plus TEVAR with ascending aorta reconstruction), and type III (GVD plus TEVAR with ascending aorta and aortic arch reconstruction with an elephant trunk (soft [surgical] or frozen [endovascular]]).A total of 42 patients (23 men [54.8%]; mean age, 62.2 ± 11.2 years) had undergone GVD, with 122 vessels revascularized (42 innominate, 42 left common carotid, and 38 left subclavian arteries). The indication for TEVAR was aneurysmal degeneration from aortic dissection in 32 patients (76.2%), a thoracic aneurysm in 9 patients (21.4%), and a perforated aortic ulcer in 1 patient (2.4%). The median duration between GVD and TEVAR was 82 days. The mean follow-up period was 25.7 ± 23.5 months. Type I repair was performed in 4, type II in 16, and type III in 22 patients. The perioperative mortality, stroke, and paraplegia rates were 9.5%, 7.1%, and 2.4%, respectively. Neither the extent of repair (P = .80) nor a history of aortic repair (P = .90) was associated with early mortality. Of the 38 patients who had survived the perioperative period, 6 had died30 days postoperatively. At 36 months, the survival estimate was 68.6% (95% confidence interval, 45.7%-83.4%). The overall primary patency of the innominate artery, left common carotid artery, and left subclavian artery was 100%, 89.5%, and 94.1%, respectively. The primary-assisted patency rate was 100% for all the vessels.We found GVD to be a safe and effective method of extending the proximal landing zone into zone 0 with outstanding primary patency rates. Further studies are required to confirm the safety and longer term durability for these patients.

Management of carotid artery stenosis (CAS) remains controversial and proper patient selection critical. Elevated neutrophil to lymphocyte ratio (NLR) has been associated with poor outcomes after vascular procedures. The effect of NLR on outcomes after carotid endarterectomy (CEA) in asymptomatic and symptomatic patients is assessed.A retrospective review was conducted of all patients between 2010 and 2018 with carotid stenosis70% as defined by CREST 2 criteria. A total of 922 patients were identified, of whom 806 were treated with CEA and 116 non-operatively with best medical therapy (BMT). Of patients undergoing CEA, 401 patients (290 asymptomatic [aCEA], 111 symptomatic [sCEA]) also had an available NLR calculated from a complete blood count with differential. All patients treated with BMT were asymptomatic and had a baseline NLR available. Kaplan-Meier analysis assessed composite ipsilateral stroke or death over 3 years.In sCEA group, the 3-year composite stroke/death rates did not differ between NLR3.0 (22.9%) vs NLR3.0 (38.1%) (P=.10). In aCEA group, patients with a baseline NLR3.0 had an increased risk of 3-year stroke/death (42.6%) compared to both those with NLR3.0 (9.3%, P.0001) and those treated with BMT (23.6%, P=.003). In patients with NLR3.0, aCEA showed a superior benefit over BMT with regard to stroke or death (9.3% vs. 26.2%, P=.02). However, in patients with NLR3.0, there was no longer a benefit to prophylactic CEA compared to BMT (42.6% vs. 22.2%, P=.05). Multivariable analysis identified NLR3.0 (HR, 3.23; 95% CI, 1.93-5.42; P.001) and congestive heart failure (HR, 2.18; 95% CI, 1.33-3.58; P=.002) as independent risk factors for stroke/death in patients with asymptomatic carotid artery stenosis.NLR3.0 is associated with an increased risk of late stroke/death after prophylactic CEA for asymptomatic carotid artery stenosis, with benefits not superior to BMT. NLR may be used to help with selecting asymptomatic patients for CEA. The effect of NLR and outcomes in symptomatic patients requires further study. Better understanding of the mechanism(s) for NLR elevation and medical intervention strategies are needed to modulate outcome risk in these patients.

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 = 663) and compared. Patients undergoing the TCAR procedure (n = 292) had higher rates of diabetes (P = .01), hyperlipidemia (P = .02), coronary artery disease (P 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.

Stroke after carotid endarterectomy (CEA) has been assessed widely. However, factors enhancing non-ipsilateral stroke risk are poorly defined. The aim of this study was to identify drivers of 30 day non-ipsilateral stroke after CEA in the Vascular Quality Initiative (VQI) and assess long-term survival based on laterality of post-operative stroke.The VQI was queried between April 1, 2003, and March 31, 2017, for all CEA. Bilateral carotid procedures within 30 days were excluded. Thirty day non-ipsilateral strokes were identified. Factors were examined to discriminate between patients with and without non-ipsilateral stroke. Univariable analysis followed by multivariable logistic regression was performed. Kaplan-Meier and log rank methods were used to estimate and compare survival.During this 14 year period, 80,230 CEA in 74,928 patients met the criteria. The average age was 70.3 ± 9.3 years. Most were male (48,506; 60%), Caucasian (73,967; 92%), smokers (60,543; 76%), and asymptomatic (43,074; 54%). Contralateral stenosis ≥70% was present in 8033 (10%) with 2239 (3%) having contralateral occlusion. In 491 (0.6%) patients, peri-operative non-ipsilateral stroke occurred. After characterising univariable associations, logistic regression identified independent drivers of non-ipsilateral stroke after CEA. Operative urgency (p = .001), symptomatic disease (p .001) and contralateral occlusion (p = .001) were pre-operative drivers. Operative predictors included shunt use (p = .008), CEA with cardiac surgery (p = .013), and CEA with concomitant proximal ipsilateral endovascular intervention (p = .01). Use of dextran (p = .005) and anti-angiotensin therapy (p = .03) were protective. Reperfusion syndrome (p .001), re-exploration (p .001), myocardial infarction (p .001), and intravenous treatment of hypotension (p .001) or hypertension (p .001) were post-operative correlates. Non-ipsilateral stroke 30 day mortality was less than ipsilateral stroke (6.1% vs. 10.3%; p = .007). Five year survival after non-ipsilateral stroke was 73%, and no different from ipsilateral stroke 76% (p = .16). Both were worse than without stroke (88%; p .001).Non-ipsilateral stroke after CEA is rare. Features driving risk surround global disease burden, combined procedures, and haemodynamic fluctuations. Contralateral occlusion independently increases non-ipsilateral stroke risk. Regardless of laterality or location, effects of stroke after CEA on long-term survival are similar.

Adding ipsilateral, proximal endovascular (IPE) intervention to carotid endarterectomy (CEA) for the treatment of tandem bifurcation and supra-aortic trunk disease is controversial. Some suggest that this combined strategy (CEA + IPE) confers no risk over isolated CEA (ICEA). Others disagree, reserving CEA + IPE for symptomatic patients. Using the Vascular Quality Initiative (VQI), this study assessed the effect of adding IPE to CEA on stroke and death risk. We further weighed CEA + IPE outcomes in the context of symptomatic status and Society for Vascular Surgery guidelines.All CEAs in the VQI database from 2003 to 2017 were reviewed. Urgent and redo CEAs were excluded. CEA + IPE procedures were identified. To isolate the effect of IPE, patients undergoing other concurrent procedures were removed, providing an ICEA cohort. Primary end points were perioperative (30-day) stroke and death. Univariate and logistic regression analyses were performed.After exclusion and identification of CEA + IPE, 66,519 procedures were available for analysis. Of these, 66,115 represented ICEA and 404 represented CEA + IPE. Most patients (60%) were male, 93% were white, and 41% were symptomatic. Average age was 70 ± 9 years. Those undergoing CEA + IPE were more likely to be female (50% vs 40%; P .001) and smokers (87% vs 76%; P .001), and they were more likely to have coronary artery disease (32% vs 27%; P = .04), congestive heart failure (14% vs 10%; P = .01), and chronic obstructive pulmonary disease (30% vs 22%; P .001). ICEA patients were more likely to have severe ipsilateral stenosis (86% vs 80%; P = .002) and to undergo intraoperative shunting (53% vs 49%; P = .05). There was no difference in 30-day mortality between cohorts (1% vs 1%; P = .23). However, CEA + IPE had higher rates of perioperative stroke (3.0% vs 1.4%; P = .01) and combined 30-day stroke and death (3.5% vs 1.8%; P = .02). When patients were stratified by symptomatic status, there were no differences in primary end points between cohorts in asymptomatic patients. In symptomatic patients, CEA + IPE carried significantly higher stroke (4.9% vs 1.9%; P = .002) and stroke and death risk (6.0% vs 2.4%; P = .002). After risk adjustment, predictors of stroke and death were diabetes (odds ratio [OR], 1.2; P = .001), symptomatic status (OR, 1.7; P .001), and CEA + IPE (OR, 1.9; P = .02).The addition of IPE to CEA confers increased stroke and death risk over ICEA. Risk is largely in symptomatic patients. Although CEA + IPE increases risk compared with ICEA, overall risk remains low. Based on this VQI analysis, CEA + IPE outcomes for asymptomatic patients fall within Society for Vascular Surgery guidelines for ICEA. Those for symptomatic patients do not, and consideration should be given to other surgical bypass, cerebral protection, and staged strategies.

The efficacy of biologic therapies in critical limb ischemia (CLI) remains elusive, in part, due to limitations in trial design and patient selection. Using a novel design, we examined the impact of complementing revascularization therapy with intramuscular JVS-100 – a non-viral gene therapy that activates endogenous regenerative repair pathways. In this double-blind, placebo-controlled, Phase 2B trial, we randomized 109 patients with CLI (Rutherford class V or VI) to 8 mg or 16 mg intramuscular injections of placebo versus JVS-100. Patients were eligible if they persistently had reduced forefoot perfusion, by toe–brachial index (TBI) or skin perfusion pressure (SPP), following successful revascularization with angiographic demonstration of tibial arterial flow to the ankle. The primary efficacy end point was a 3-month wound healing score assessed by an independent wound core laboratory. The primary safety end point was major adverse limb events (MALE). Patients’ mean age was 71 years, 33% were women, 79% had diabetes, and 8% had end-stage renal disease. TBI after revascularization was 0.26, 0.27, and 0.26 among the three groups (placebo, 8 mg, and 16 mg injections, respectively). Only 26% of wounds completely healed at 3 months, without any differences between the three groups (26.5%, 26.5%, and 25%, respectively). Similarly, there were no significant changes in TBI at 3 months. Three (2.8%) patients died and two (1.8%) had major amputations. Rates of MALE at 3 months were 8.8%, 20%, and 8.3%, respectively. While safe, JVS-100 failed to improve wound healing or hemodynamic measures at 3 months. Only one-quarter of CLI wounds healed at 3 months despite successful revascularization, highlighting the need for additional research in therapies that can improve microcirculation in these patients. ClinicalTrials.gov Identifier: NCT02544204

Transcarotid artery revascularization (TCAR) is a hybrid approach to carotid revascularization. Limited information is available on the differences in periprocedural complications and performance measures of TCAR for men compared with women and for older vs younger adults.The patient, lesion, and physician characteristics were collected for all TCAR procedures performed by each physician worldwide in an international quality assurance database between March 3, 2009 and May 7, 2020. Clinical composite (ie, death, stroke, transient ischemic attack, myocardial infarction) and technical composite (ie, aborted procedure, conversion to surgery, bleeding, dissection, cranial nerve injury, device failure) adverse events within 24 hours of the procedure were recorded. Four performance measures were recorded: flow-reversal time, fluoroscopy time, contrast volume, and skin-to-skin time. Poisson regressions were used to assess the effects of age and sex on the incidence of clinical and technical composite adverse events. Linear regressions were used to compare the four performance measures.A total of 18,240 TCARs were performed by 1273 physicians; 34.9% of the patients were women and 37.5% were symptomatic. The overall incidence of clinical and technical composite adverse events was low. The adjusted clinical (1.62% [95% confidence interval (CI), 1.17%-2.23%] vs 1.35% [95% CI, 1.01%-1.79%]; P = .22) and technical (7.84% [95% CI, 6.85%-8.97%] vs 7.80% [95% CI, 6.94%-8.77%]; P = .93) composite adverse event rates did not vary for women vs men. The adjusted clinical (P = .65) and technical (P = .55) composite adverse event rates also did not vary by age. The adjusted skin-to-skin time was shorter for the women (76.6 minutes; 95% CI, 74.6-78.6) than for the men (77.7 minutes; 95% CI, 75.7-79.6; P = .002). Significant differences were found by age group for fluoroscopy time, flow-reversal time, and skin-to-skin time, although the magnitude of these differences was small (1 minute for each).The clinical and technical outcomes of TCAR are not affected by age or sex. We found clinically minor differences in the procedural performance measures when stratified by age and sex. In addition to being safe for younger individuals, TCAR could also be the preferred method for performing carotid stenting in women and older patients, in particular, older women.

Made available in DSpace on 2022-04-28T19:47:00Z (GMT). No. of bitstreams: 0 Previous issue date: 2021-10-01 Introduction: Aortic graft infection remains a considerable clinical challenge, and it is unclear which variables are associated with adverse outcomes among patients undergoing partial resection. Methods: A retrospective, multi-institutional study of patients who underwent partial resection of infected aortic grafts from 2002 to 2014 was performed using a standard database. Baseline demographics, comorbidities, operative, and postoperative variables were recorded. The primary outcome was mortality. Descriptive statistics, Kaplan-Meier (KM) survival analysis, and Cox regression analysis were performed. Results: One hundred fourteen patients at 22 medical centers in 6 countries underwent partial resection of an infected aortic graft. Seventy percent were men with median age 70 years. Ninety-seven percent had a history of open aortic bypass graft: 88 (77%) patients had infected aortobifemoral bypass, 18 (16%) had infected aortobiiliac bypass, and 1 (0.8%) had an infected thoracic graft. Infection was diagnosed at a median 4.3 years post-implant. All patients underwent partial resection followed by either extra-anatomic (47%) or in situ (53%) vascular reconstruction. Median follow-up period was 17 months (IQR 1, 50 months). Thirty-day mortality was 17.5%. The KM-estimated median survival from time of partial resection was 3.6 years. There was no significant survival difference between those undergoing in situ reconstruction or extra-anatomic bypass (P = 0.6). During follow up, 72% of repairs remained patent and 11% of patients underwent major amputation. On univariate Cox regression analysis, Candida infection was associated with increased risk of mortality (HR 2.4; P = 0.01) as well as aortoenteric fistula (HR 1.9, P = 0.03). Resection of a single graft limb only to resection of abdominal (graft main body) infection was associated with decreased risk of mortality (HR 0.57, P = 0.04), as well as those with American Society of Anesthesiologists classification less than 3 (HR 0.35, P = 0.04). Multivariate analysis did not reveal any factors significantly associated with mortality. Persistent early infection was noted in 26% of patients within 30 days postoperatively, and 39% of patients were found to have any post-repair infection during the follow-up period. Two patients (1.8%) were found to have a late reinfection without early persistent postoperative infection. Patients with any post-repair infection were older (67 vs. 60 years, P = 0.01) and less likely to have patent repairs during follow up (59% vs. 32%, P = 0.01). Patients with aortoenteric fistula had a higher rate of any post-repair infection (63% vs. 29%, P < 0.01) Conclusion: This large multi-center study suggests that patients who have undergone partial resection of infected aortic grafts may be at high risk of death or post-repair infection, especially older patients with abdominal infection not isolated to a single graft limb, or with Candida infection or aortoenteric fistula. Late reinfection correlated strongly with early persistent postoperative infection, raising concern for occult retained infected graft material. University Hospitals Cleveland Medical Center Case Western Reserve University School of Medicine the Ronald Reagan UCLA Medical Center University of California Los Angeles SSM Healthcare Semmelweis University Keck School of Medicine University of Southern California University of North Carolina School of Medicine University of Arizona the Indiana University Health Physicians Vascular Surgery Michigan Medicine University of Michigan University Heart Center Hamburg University Medical Center Hamburg-Eppendorf Penn State Heart and Vascular Institute Milton S. Hershey Medical Center Johns Hopkins Hospital The Heart Hospital Baylor Plano the Cardiovascular Surgery Clinic University of Messina National & Kapodistrian University of Athens University of Patras Keio University University of Pennsylvania Vancouver General Hospital & University of British Columbia Mayo Clinic Christiana Health System University of Chicago Harborview Medical Center University of Washington Washington University Stanford University CHU de Poitiers Baylor College of Medicine MedStar Georgetown University Hospital SSM Health St. Louis University Faculdade de Medicina de Botucatu-Unesp Beth Israel Deaconness Medical Center Brigham and Women's Hospital St. Joseph's Hospital Massachusetts General Hospital Robert Wood Johnson Medical School Rutgers University Vita-Salute University School of Medicine San Raffaele Scientific Institute Kaiser Permanente University Heart Center Freiburg-Bad Krozingen Freiburg University of Virginia Medical Center University of Siena Kyung Hee University Gustave Dron Hospital Centro Hospitalar de Lisboa Norte Wexner Medical Center Ohio State University Uppsala University University Hospital of Trieste University Hospital of Verona University Hospital of Padova University of Alabama University of California Davis University of Florida Michael E. DeBakey Department of Surgery Baylor College of Medicine University Hospital University of Missouri Faculdade de Medicina de Botucatu-Unesp