Endpoints and definitions
The primary endpoint of SAVI-1 was the rate of major cardiac and cerebrovascular events (MACCE) at 30 days and 1 year, defined as composite of death, myocardial infarction, reintervention, and stroke. The primary endpoint of SAVI-2 was the incidence of all-cause mortality at 30 days. Secondary end-points according to the Valvular Academic Research Consortium-2 (VARC-2) guidelines [7] were: mortality, stroke, myocardial infarction, bleeding complications, acute kidney injury, vascular complications, conduction disturbances and arrhythmias, and other TAVI-related complications (i.e. valve-in-valve, conversion to open heart, coronary obstruction, unplanned use of cardiopulmonary bypass, ventricular septal perforation, mitral valve apparatus damage/dysfunction, cardiac tamponade, endocarditis, valve thrombosis, valve migration/embolization) at 30 days and 1 year. Functional improvement from baseline was assessed via the New York Heart Association (NYHA) functional classification at the 30-day and 1-year follow-ups. We intend to compare safety and performance outcomes between SAVI-1 and -2.