Standardized endpoint definitions for trials of transcatheter left atrial appendage closure: a consensus from the Left Atrial Appendage Academic Research Consortium
Abstract Since its introduction in 2002, left atrial appendage closure (LAAC) has rapidly expanded as an alternative to anticoagulation in patients with atrial fibrillation at high risk of stroke. Harmonized processes for data collection, analysis, and reporting in LAAC trials are essential to enhance research quality and improve clinical practice. The Left Atrial Appendage Academic Research Consortium (LAARC) initiative is an independent collaboration of academic research organizations, cardiology and neurology experts, clinical trialists, and regulatory authorities from the USA, Europe, and Asia. The consortium engaged clinical experts, regulators—including the US Food and Drug Administration (FDA), European Notified Bodies, and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA)—and industry leaders to define standardized study elements and endpoints for LAAC trials. Key considerations included alignment with prior Academic Research Consortium initiatives, procedural and mechanistic insights, and clinical relevance. Consensus definitions were proposed for mortality, stroke, bleeding, and device performance, along with composite endpoints for safety and effectiveness. The proposed LAARC consensus definitions aim to standardize endpoint reporting, improve comparability across studies, and support regulatory and clinical trial applications for this evolving therapy through broad dissemination in the peer-reviewed literature.
COVID19 impact on women on both sides of the frontline: The American College of Cardiology Women in Cardiology Section’s International Working Group perspective
At the beginning of the SARS Co V2 (COVID-19) pandemic, women worldwide represented the majority of health care workers. As part of the fight against the pandemic, women health care workers became a part of the significant frontline response. This led to unique challenges that affected women physicians as well as the women patients they were taking care of. The American College of Cardiology Women in Cardiology International Working Group set up a webinar to discuss the challenges being faced by women physicians and women patients in various parts of the world and look towards finding possible solutions for these issues in a webinar themed ?WIC Global Perspectives: COVID-19.?