Vascular complications after transcatheter aortic valve implantation and their association with mortality reevaluated by the valve academic research consortium definitions

Vascular complications (VC) after transcatheter aortic valve implantation (TAVI) are reported using various criteria and several access site approaches. We aimed to describe them in a solely percutaneous transfemoral TAVI approach and their association with survival using both the updated Valve Academic Research Consortium (VARC)-2 criteria and the former VARC-1 criteria. From March 2009 to September 2013, 403 consecutive patients at a mean age (±SD) of 83 ± 6 years underwent percutaneous transfemoral TAVI. VC were defined by both VARC-1 and VARC-2 criteria and analyzed separately. Cox proportional hazard ratio models for all-cause mortality were adjusted separately as defined by each criteria. VARC-1-defined and VARC-2-defined VC occurred in 71 (18%) and 78 (19%) patients, respectively, with 15 (4%) and 33 (8%) defined as major VC. The difference in frequency of major and minor VC was mainly driven by VARC-2 implementation of major bleeding events. With either VARC definition, patients with minor VC had similar mortality and complications rates as those patients without VC. In multivariate analyses, referenced to patients with minor or no VC, only VARC-1-defined major VC were significantly associated with increased mortality (hazard ratio 3.52; confidence interval 1.5 to 8.4; p = 0.005), whereas VARC-2-defined major VC were found to be only marginally significant (hazard ratio 1.9; confidence interval 0.9 to 3.9; p = 0.08). In conclusion, the implementation of the VARC-2 criteria resulted in a higher rate of reported major VC after TAVI compared with VARC-1 criteria, mainly by the inclusion of major bleeding events and a reduced association with patient mortality.