Standardized Endpoint Definitions for Transcatheter Aortic Valve Implantation Clinical Trials

摘要: Objectives To propose standardized consensus definitions for important clinical endpoints in transcatheter aortic valve implantation (TAVI), investigations an effort to improve the quality of research and enable meaningful comparisons between trials. make these accessible all stakeholders TAVI through a peer reviewed publication, on behalf public health. Background Transcatheter may provide worthwhile less invasive treatment many patients with severe stenosis since its introduction medical community 2002, there has been explosive growth procedures. The integration into daily practice should be guided by academic activities, which requires harmonized structured process data collection, interpretation, reporting during well-conducted trials. Methods Results Valve Academic Research Consortium established independent collaboration organizations specialty societies (cardiology cardiac surgery) USA Europe. Two meetings, San Francisco, California (September 2009) Amsterdam, Netherlands (December 2009), including key physician experts, representatives from U.S. Food Drug Administration (FDA) device manufacturers, were focused creating consistent endpoint recommendations implementation programs. Important considerations developing included: 1) respect historical legacy surgical guidelines; 2) identification pathophysiological mechanisms associated events; 3) emphasis relevance. Consensus criteria developed following endpoints: mortality, myocardial infarction, stroke, bleeding, acute kidney injury, vascular complications, prosthetic performance. Composite safety effectiveness also recommended. Conclusions Although will invariably include certain arbitrary features, organized multidisciplinary develop specific consistency across studies that can facilitate evaluation this new catheter-based therapy. broadly based described document useful regulatory trial purposes.