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Objective: Current guidelines recommend dual antiplatelet therapy (DAPT) in patients undergoing carotid artery stenting. The most common DAPT regimen is aspirin and clopidogrel, a P2Y12 receptor antagonist; however, the prevalence of clopidogrel resistance (CR) in patients undergoing percutaneous coronary interventions may exceed 60%. Few studies have investigated the prevalence and impact of CR in patients undergoing extracranial carotid artery stenting, particularly transcarotid artery revascularization (TCAR)., Methods: Consecutive high-risk patients ≥ 18 years who underwent TCAR for high grade (≥70%) and/or symptomatic (≥50%) carotid stenosis with preoperative P2Y12 testing between August 2019 and December 2021 were identified across five institutions. Preoperative platelet reactivity was measured with the VerifyNow P2Y12 Reaction Unit (PRU) Test (Instrumentation Laboratory, Bedford, MA), with CR defined as PRU ≥ 194 and hyper-response as PRU <70. Patients without preoperative P2Y12 testing within 30 days prior to TCAR or those on a non-clopidogrel P2Y12 inhibitor preoperatively were excluded. The primary outcome of interest was prevalence of CR. Secondary outcomes of interest included the incidence of ischemic and hemorrhagic complications., Results: Of 92 patients identified, the majority were male (59%) and Caucasian (75%) with a mean age of 75 years (±8, range 56 - 92). Preoperatively, 93% of patients were on aspirin, 100% on clopidogrel, and 13% on therapeutic anticoagulation. At presentation, 36% were symptomatic. The mean preoperative P2Y12 was 156 PRU (±76, range 6 - 349). In total, 30 (33%) patients met criteria for CR (mean PRU 240 ± 37; range 197-349), and 15 (16%) met criteria for hyper-responder (mean PRU 38 ± 20; range 6-68). There was no significant difference by clopidogrel response phenotype in terms of sex ( p = 0.246), race ( p = 0.384), or symptomatic presentation ( p = 0.956). Postoperatively, the cumulative incidence of stroke and MI was 2.1%, with no statistically significant difference in the incidence of in-hospital stroke (PRU 238, p = 0.489) or MI (PRU 168, p = 1) between clopidogrel phenotypes. Three (3.3%) patients, one CR (PRU 240) and two responders (PRU 119 and PRU 189), experienced postoperative access site hematomas that required no subsequent intervention. No other index hospitalization hemorrhagic complications occurred., Conclusions: Using preoperative P2Y12 testing with a threshold PRU ≥ 194 to define CR, we identified a high prevalence of CR in patients undergoing TCAR similar to that in the pre-existing coronary literature. We found no significant differences in postoperative ischemic or hemorrhagic complications by clopidogrel response phenotype, although complication rates in the overall study cohort were low. CR may be a spectrum from responder to partial responder to complete non-responder, and this may account for the differences in our CR cohort compared to the ROADSTER 2 protocol deviation cohort. Further investigation is warranted to determine if a quantitative assessment of CR is sufficient to identify patients at risk of developing secondary cerebrovascular ischemic events in this patient population., Competing Interests: Declaration of conflicting interestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Background: Postoperative respiratory failure (PRF) is associated with increased hospital charges and worse patient outcomes. Reliable prediction models can help to guide postoperative planning to optimize care, to guide resource allocation, and to foster shared decision-making with patients., Research Question: Can a predictive model be developed to accurately identify patients at high risk of PRF?, Study Design and Methods: In this single-site proof-of-concept study, we used structured query language to extract, transform, and load electronic health record data from 23,999 consecutive adult patients admitted for elective surgery (2014-2021). Our primary outcome was PRF, defined as mechanical ventilation after surgery of > 48 h. Predictors of interest included demographics, comorbidities, and intraoperative factors. We used logistic regression to build a predictive model and the least absolute shrinkage and selection operator procedure to select variables and to estimate model coefficients. We evaluated model performance using optimism-corrected area under the receiver operating curve and area under the precision-recall curve and calculated sensitivity, specificity, positive and negative predictive values, and Brier scores., Results: Two hundred twenty-five patients (0.94%) demonstrated PRF. The 18-variable predictive model included: operations on the cardiovascular, nervous, digestive, urinary, or musculoskeletal system; surgical specialty orthopedic (nonspine); Medicare or Medicaid (as the primary payer); race unknown; American Society of Anesthesiologists class ≥ III; BMI of 30 to 34.9 kg/m 2 ; anesthesia duration (per hour); net fluid at end of the operation (per liter); median intraoperative FIO 2 , end title CO 2 , heart rate, and tidal volume; and intraoperative vasopressor medications. The optimism-corrected area under the receiver operating curve was 0.835 (95% CI,0.808-0.862) and the area under the precision-recall curve was 0.156 (95% CI, 0.105-0.203)., Interpretation: This single-center proof-of-concept study demonstrated that a structured query language extract, transform, and load process, based on readily available patient and intraoperative variables, can be used to develop a prediction model for PRF. This PRF prediction model is scalable for multicenter research. Clinical applications include decision support to guide postoperative level of care admission and treatment decisions.

Registry Assessment of Peripheral Interventional Devices (RAPID) initiated the Pathways Program to provide a transparent, collaborative forum in which to pursue insights into multiple unresolved questions on benefit-risk of paclitaxel-coated devices, including understanding the basis of the mortality signal, without a demonstrable potential biological mechanism, and whether the late mortality signal could be artifact intrinsic to multiple independent prospective randomized data sources that did not prespecify death as a long-term end point. In response to the directive, the LEAN-Case Report Form working group focused on enhancements to the RAPID Phase I Minimum Core Data set through the addition of key clinical modifiers that would be more strongly linked to longer-term mortality outcomes after peripheral arterial disease intervention in the drug-eluting device era, with the goal to have future mortality signals more accurately examined., (Copyright © 2023 Society for Vascular Surgery. All rights reserved.)

Background: Few interventions are known to reduce the incidence of respiratory failure that occurs following elective surgery (postoperative respiratory failure; PRF). We previously reported risk factors associated with PRF that occurs within the first 5 days after elective surgery (early PRF; E-PRF); however, PRF that occurs six or more days after elective surgery (late PRF; L-PRF) likely represents a different entity. We hypothesized that L-PRF would be associated with worse outcomes and different risk factors than E-PRF., Methods: This was a retrospective matched case-control study of 59,073 consecutive adult patients admitted for elective non-cardiac and non-pulmonary surgical procedures at one of five University of California academic medical centers between October 2012 and September 2015. We identified patients with L-PRF, confirmed by surgeon and intensivist subject matter expert review, and matched them 1:1 to patients who did not develop PRF (No-PRF) based on hospital, age, and surgical procedure. We then analyzed risk factors and outcomes associated with L-PRF compared to E-PRF and No-PRF., Results: Among 95 patients with L-PRF, 50.5% were female, 71.6% white, 27.4% Hispanic, and 53.7% Medicare recipients; the median age was 63 years (IQR 56, 70). Compared to 95 matched patients with No-PRF and 319 patients who developed E-PRF, L-PRF was associated with higher morbidity and mortality, longer hospital and intensive care unit length of stay, and increased costs. Compared to No-PRF, factors associated with L-PRF included: preexisiting neurologic disease (OR 4.36, 95% CI 1.81-10.46), anesthesia duration per hour (OR 1.22, 95% CI 1.04-1.44), and maximum intraoperative peak inspiratory pressure per cm H 2 0 (OR 1.14, 95% CI 1.06-1.22)., Conclusions: We identified that pre-existing neurologic disease, longer duration of anesthesia, and greater maximum intraoperative peak inspiratory pressures were associated with respiratory failure that developed six or more days after elective surgery in adult patients (L-PRF). Interventions targeting these factors may be worthy of future evaluation., (© 2022. The Author(s).)

Background: Current recommendations on carotid revascularization postulate that women have both increased perioperative risks, such as stroke and death, as well as reduced benefit from intervention. These recommendations do not include data on transcarotid artery revascularization (TCAR). This study strives to compare safety and benefits of TCAR, TFCAS (Transfemoral Carotid Artery Stenting), and CEA (Carotid Endarterectomy) with regard to patient sex., Methods: We performed retrospective analysis of the Society for Vascular Surgery (SVS) Vascular Quality Initiative (VQI) CEA and stenting registries, as well as TCAR Surveillance Project data. We compared outcomes after TCAR, TFCAS, and CEA based on sex. The primary outcome was the rate of in-hospital stroke or death. Secondary outcomes included in-hospital stroke, death, transient ischemic attack (TIA), myocardial infarction (MI), stroke/death/MI, stroke/TIA, and recurrent ipsilateral stroke and/or death at 1-year of follow-up., Results:  A total of 75,538 patients were included, of which 28,960 (38.3%) were female and 46,578 (61.7%) were male. TFCAS females had more than 2 times higher odds of stroke/death (OR:2.85, 95%CI: 2.21-3.67, P < 0.001) and stroke/death/MI (OR:2.23, 95%CI:1.75-2.83, P < 0.001) when compared to CEA females. Odds of TIA were also higher in both TFCAS females (OR:2.01, 95%CI:1.19-3.42, P = 0.010) and TCAR females (OR:1.91, 95%CI:1.09-3.35, P = .023) when compared to CEA females. However, only TFCAS females experienced increased odds of stroke/TIA (OR:1.96, 95%CI:1.45-2.65, P < 0.001) when compared to CEA females. TFCAS males had almost twice the odds of stroke/death (OR:1.74, 95%CI:1.39-2.16, P < 0.001) and 44% higher odds of stroke/death/MI (OR:1.44, 95%CI:1.19-1.75, P < 0.001), and more than 3-times increased odds of death (OR:3.45, 95%CI:2.53-4.71, P < 0.001) when compared to CEA males. Odds of in-hospital stroke were comparable between TFCAS and CEA after adjusting for covariates. TCAR males have half the odds of MI when compared to CEA males (OR:0.52, 95%CI:0.34-0.80, P = 0.003). At 1-year TCAR had comparable risk of stroke/death while TFCAS had increased risk of stroke/death when compared to CEA among both males and females., Conclusion: TCAR performed similarly to CEA in both sexes regardless of symptomatic status. Stroke/death and stroke/death/MI rates were similar in symptomatic and asymptomatic males and females treated by CEA or TCAR. The 1-year outcomes of TCAR were also comparable to CEA in both sexes. It seems that TCAR may be a safe alternative to CEA particularly in women when surgical risk prohibits CEA and while TFCAS is associated with substantial adverse outcomes., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Objective: Previous studies have shown no differences in the outcomes of transcarotid artery revascularization (TCAR) performed with general anesthesia (GA) vs local or regional anesthesia (LRA). To date, no study has specifically compared the outcomes of TCAR to those of carotid endarterectomy (CEA) stratified by anesthetic type. The aim of the present study was to identify the effect of the anesthetic type on the outcomes of TCAR vs CEA., Methods: Patients undergoing CEA and TCAR for carotid artery stenosis from 2016 to 2019 in the Vascular Quality Initiative were included. We excluded patients who had undergone concomitant procedures, patients with more than two stented lesions, and patients who had undergone the procedure for a nonatherosclerotic indication. Propensity score matching was performed between the two procedures stratified by the anesthetic type for age, sex, race, presenting symptoms, major comorbidities (ie, hypertension, diabetes, coronary artery disease, congestive heart failure, chronic obstructive pulmonary disease, chronic kidney disease), previous coronary artery bypass grafting or percutaneous transluminal coronary intervention, previous CEA or carotid artery stenting, degree of ipsilateral stenosis, the presence of contralateral occlusion, and preoperative medications. Intergroup differences between the treatment groups and differences in the perioperative outcomes were tested using the McNemar test for categorical variables and the paired t test or Wilcoxon matched pairs signed rank test for continuous variables, as appropriate. The relative risk (RR) and 95% confidence intervals (CIs) were estimated as the ratio of the probability of the outcome event for the patients treated within each treatment group., Results: A total of 65,337 patients were included. Of the 65,337 patients, 59,664 had undergone carotid revascularization under GA (91%). When performed with LRA, TCAR and CEA had similar rates of stroke, death, and MI. However, when performed with GA, patients undergoing TCAR had a 50% decreased risk of MI compared with those undergoing CEA under GA (0.5% vs 1.0%; RR, 0.50; 95% CI, 0.32-0.80; P < .01). When stratified by symptomatic status, patients undergoing TCAR with GA for symptomatic carotid disease had a 67% decreased risk of MI compared with those undergoing CEA with GA for symptomatic disease (0.4% vs 1.2%; RR, 0.33; 95% CI, 0.15-0.75; P < .01). In contrast, no difference was found in the risk of MI between patients undergoing CEA vs TCAR for asymptomatic carotid disease (0.6% vs 0.9%; RR, 0.64; 95% CI, 0.37-1.14; P = .13)., Conclusions: The results from the present study have confirmed previous studies suggesting that TCAR confers a lower risk of MI compared with CEA. However, our findings demonstrated no differences in the MI rates between TCAR and CEA when performed with LRA. Patients undergoing TCAR under GA had lower rates of MI compared with patients undergoing CEA under GA. When stratified by symptomatic status, the benefit of TCAR persisted only for the symptomatic patients., (Copyright © 2021 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)