Spitzer, Ernest

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.

Abstract Aims This study aimed to establish 2D and M-mode echocardiographic reference values for cardiac chambers, outflow tracts, and great vessels for school children living at high altitudes, differentiated between males and females. Methods and results This post hoc analysis included children with normal echocardiography from a cluster randomized cross-sectional survey of rheumatic heart disease among school children in Peru. The echocardiograms were acquired with a portable machine and the images were analysed centrally with a standardized methodology. Body surface area (BSA) was used as an independent variable to predict the mean values of echocardiographic measurements for both male and female groups. Reference values are presented on z-scores and nomograms based on sex. Propensity score matching was used to compare sexes. A total of 985 students aged 5–16 years were included. The Haycock formula provided the best fit and was used when presenting data as predicted values for a given BSA. The z-score and nomograms for all essential parameters of cardiac chambers, great vessels, and functional surrogates are presented based on sex. The majority of the parameters were significantly different per sex after propensity score matching. Conclusion Normal reference values and nomograms of cardiac chambers, outflow tracts, and great arteries in healthy school children living at high altitudes based on sex were reported. These data partly addressed the existing gaps in paediatric echocardiographic nomograms.