Shah, Binita

BACKGROUND: Randomized trials comparing radial and femoral access report access site crossover rates of 3% to 9% for radial access and 1% to 3% for femoral access. However, contemporary real-world crossover rates are not well characterized. The aim was to evaluate contemporary trends and predictors of vascular access site crossover during percutaneous coronary intervention (PCI). METHODS: We analyzed index PCI procedures recorded in the National Cardiovascular Data Registry CathPCI Registry from 2018 to 2024. Access site crossover was identified using documented access data, with radial-to-femoral crossover inferred when the final successful access site was femoral. Temporal trends and clinical predictors of crossover were examined. Operator experience was assessed using cumulative total and radial PCI volumes from 2011 to 2024 as captured in CathPCI Registry versions 4 and 5. RESULTS: Among 3 861 790 index PCIs, 192 902 (5.0%) involved access site crossover, with a modest increase over time. Radial-to-femoral crossover accounted for 81.2% of crossover events. Factors independently associated with crossover included older age, female sex, higher body mass index, and peripheral vascular disease. Operators with the lowest total PCI volume and the lowest radial PCI volume experienced the highest crossover rates. Notably, operators with low radial PCI volume demonstrated a substantial decline in radial-to-femoral crossover over the study period. CONCLUSIONS: In contemporary clinical practice, access site crossover rates are consistent with those reported in randomized trials. Although crossover occurs more frequently among lower-volume operators, rates decline with increasing operator experience, supporting the presence of a radial access learning curve and improvement in procedural performance over time.

AbstractRandomized controlled trials (RCTs) remain the gold standard to evaluate clinical interventions, producing the highest level of evidence while minimizing potential bias. Inadequate recruitment is a commonly encountered problem that undermines the completion and generalizability of RCTs—and is even more challenging when enrolling amidst a pandemic. Here, we reflect on our experiences with virtual recruitment of non‐hospitalized patients in the United States for ColCorona, an international, multicenter, randomized, placebo‐controlled coronavirus disease 2019 (COVID‐19) drug trial. Recruitment challenges during a pandemic include constraints created by shelter‐in‐place policies and targeting enrollment according to national and local fluctuations in infection rate. Presenting a study to potential participants who are sick with COVID‐19 and may be frightened, overwhelmed, or mistrusting of clinical research remains a challenge. Strategies previously reported to improve recruitment include transparency, patient and site education, financial incentives, and person‐to‐person outreach. Active measures taken during ColCorona to optimize United States recruitment involved rapid expansion of sites, adjustment of recruitment scripts, assessing telephone calls versus text messages for initial contact with participants, institutional review board‐approved financial compensation, creating an infrastructure to systematically identify potentially eligible patients, partnering with testing sites, appealing to both self‐interest and altruism, and large‐scale media efforts with varying degrees of success.

Background: Women have a higher rate of adverse events after mitral valve surgery. We sought to evaluate whether outcomes after transcatheter edge-to-edge repair intervention by sex have similar trends to mitral valve surgery. Methods: The primary outcome was 1-year major adverse events defined as a composite of all-cause mortality, stroke, and any bleeding in the overall study cohort. Patients who underwent transcatheter edge-to-edge repair for mitral regurgitation with the MitraClip system in the Society of Thoracic Surgery/American College of Cardiology Transcatheter Valve Therapy registry were evaluated. Linked administrative claims from the Centers for Medicare and Medicaid Services were used to evaluate 1-year clinical outcomes. Associations between sex and outcomes were evaluated using a multivariable logistic regression model for in-hospital outcomes and Cox model for 1-year outcomes. Results: From November 2013 to March 2017, 5295 patients, 47.6% (n=2523) of whom were female, underwent transcatheter edge-to-edge repair. Females were less likely to have >1 clip implanted ( P <0.001) and had a lower adjusted odds ratio of device success (adjusted odds ratio, 0.78 [95% CI, 0.67–0.90]), driven by lower odds of residual mitral gradient <5 mm Hg (adjusted odds ratio, 0.54 [CI, 0.46–0.63]) when compared with males. At 1-year follow-up, the primary outcome did not differ by sex. Female sex was associated with lower adjusted 1-year risk of all-cause mortality (adjusted hazard ratio, 0.80 [CI, 0.68–0.94]), but the adjusted 1-year risk of stroke and any bleeding did not differ by sex. Conclusions: No difference in composite outcome of all-cause mortality, stroke, and any bleeding was observed between females and males. Adjusted 1-year all-cause mortality was lower in females compared with males.

AbstractThe Society for Cardiovascular Angiography and Interventions (SCAI) Think Tank is a collaborative venture that brings together interventional cardiologists, administrative partners, and select members of the cardiovascular industry community annually for high‐level field‐wide discussions. The 2021 Think Tank was organized into four parallel sessions reflective of the field of interventional cardiology: (a) coronary intervention, (b) endovascular medicine, (c) structural heart disease, and (d) congenital heart disease. Each session was moderated by a senior content expert and co‐moderated by a member of SCAI's Emerging Leader Mentorship program. This document presents the proceedings to the wider cardiovascular community in order to enhance participation in this discussion, create additional dialog from a broader base, and thereby aid SCAI, the industry community and external stakeholders in developing specific action items to move these areas forward.

AbstractObjectivesThe aim of this study was to determine the prevalence of peripheral artery disease (PAD) and its association with in‐hospital outcomes after endovascular transcatheter aortic valve replacement (EV‐TAVR).BackgroundTAVR is an established treatment for patients at prohibitive, high, or intermediate surgical risk. PAD is a significant comorbidity in the determination of surgical risk. However, data on association of PAD with outcomes after EV‐TAVR are limited.MethodsPatients in the National Inpatient Sample who underwent EV‐TAVR between January 1, 2012 and September 30, 2015 were evaluated. The primary outcome was in‐hospital mortality.ResultsA total of 51,685 patients underwent EV‐TAVR during the study period. Of these, 12,740 (24.6%) had a coexisting diagnosis of PAD. The adjusted odds for in‐hospital mortality [OR 1.08 (95% CI 0.83–1.41)], permanent pacemaker implantation [OR 0.98 (0.85–1.14)], conversion to open aortic valve replacement [OR 1.05 (0.49–2.26)], or acute myocardial infarction [OR 1.31(0.99–1.71)] were not different in patients with versus without PAD. However, patients with PAD had greater adjusted odds of vascular complications [OR 1.80 (1.50–2.16)], major bleeding [OR 1.20 (1.09–1.34)], acute kidney injury (AKI) [OR 1.19 (1.05–1.36)], cardiac complications [aOR 1.21 (1.01–1.44)], and stroke [OR 1.39(1.10–1.75)] compared with patients without PAD. Length of stay (LOS) was significantly longer for patients with PAD [7.23 (0.14) days vs. 7.11 (0.1) days, p < 0.001].ConclusionOf patients undergoing EV‐TAVR, ~25% have coexisting PAD. PAD was not associated with increased risk of in‐hospital mortality but was associated with higher risk of vascular complications, major bleeding, AKI, stroke, cardiac complications, and longer LOS.

Numerous definitions have been proposed for the diagnosis of myocardial infarction (MI) after coronary revascularization. The universal definition for MI designates post procedural biomarker thresholds for defining percutaneous coronary intervention (PCI)‐related MI (type 4a) and coronary artery bypass grafting (CABG)‐related MI (type 5) which are of uncertain prognostic importance. In addition, for both MI types cTn is recommended as the biomarker of choice, the prognostic significance of which is less well validated than CK‐MB. Widespread adoption of a MI definition not clearly linked to subsequent adverse events such as mortality or heart failure may have serious consequences for the appropriate assessment of devices and therapies, may affect clinical care pathways, and may result in misinterpretation of physician competence. Rather than employing an MI definition sensitive for small degrees of myonecrosis (the occurrence of which, based on contemporary large‐scale studies, are unlikely to have important clinical consequences), it is instead recommended that a threshold level of biomarker elevation which has been strongly linked to subsequent adverse events in clinical studies be used to define a “clinically relevant MI.” The present document introduces a new definition for "clinically relevant MI" after coronary revascularization (PCI or CABG) which is applicable for use in clinical trials, patient care, and quality outcomes assessment. © 2013 Wiley Periodicals, Inc.