Paravalvular leaks

The VARC (Valve Academic Research Consortium) for transcatheter aortic valve replacement set the standard for selecting appropriate clinical endpoints reflecting safety and effectiveness of transcatheter devices, and defining single and composite clinical endpoints for clinical trials. No such standardization existed for circumferentially sutured surgical valve paravalvular leak (PVL) closure. PVL Academic Research Consortium sought to provide core principles, appropriate clinical endpoints, and endpoint definitions to be used in clinical trials of PVL closure devices. The PVL ARC met to review evidence and make recommendations for assessment of disease severity, data collection, and updated endpoint definitions. A 5-class grading scheme to evaluate PVL was developed in concordance with VARC recommendations. Unresolved issues in the field were outlined. PVL ARC provides recommendations for assessment of disease severity, data collection, and endpoint definitions.

Note: paragraph extracted from PVL ARC, available through the link below.