The clinical impact of vascular complications as defined by VARC-1 vs. VARC-2 in patients following transcatheter aortic valve implantation

AIMS: The Valve Academic Research Consortium (VARC) recommendations were devised to standardise clinical endpoint definitions which best reflect the safety and efficacy of transcatheter aortic valve implantation (TAVI). The categorisation of vascular complications (VC) is greatly affected by the definition, but the impact of its change is unclear. We sought to compare VC between VARC-1 and VARC-2 definitions as a predictor for survival. METHODS AND RESULTS: A series of 376 patients undergoing TAVI by the transfemoral or transapical approach was studied. We defined VC according to VARC-1 and VARC-2, and compared the mortality one year after the procedure. Kaplan-Meier curves showed numerically lower survival rates at one year by major VC with both definitions, but only VARC-2 had statistical significance: 79.3% vs. 60.7% with VARC-2 (p=0.014), and 78.9% vs. 70.5% with VARC-1 (p=0.20). Cox regression multivariable models showed major VC with VARC-2 definition to be an independent predictor of mortality (hazard ratio of 3.0, 95% confidence interval: 1.4-6.6, p=0.006), but not when it was substituted by the VARC-1 definition (p=0.15). CONCLUSIONS: The VARC-2 definition of VC offers better predictive value of survival than the VARC-1 definition, supporting its efficacy as a standard definition.