Impact of Major Vascular Complication Access Site Status on Mortality after Transfemoral Transcatheter Aortic Valve Replacement ― Results from the FinnValve Registry ―

Background: The aim of this study was to investigate the impact of anatomical site status and major vascular complication (MVC) severity on the outcome of transfemoral transcatheter aortic valve replacement (TF-TAVR). Methods and Results: The FinnValve registry enrolled consecutive TAVR patients from 2008 to 2017. MVC was divided into 2 groups: non-access site-related MVC (i.e., MVC in aorta, aortic valve annulus or left ventricle); and access site-related MVC (i.e., MVC in iliac or femoral arteries). Severity of access site-related MVC was measured as units of red blood cell (RBC) transfusion. Of 1,842 patients who underwent TF-TAVR, 174 had MVC (9.4%; non-access site related, n=29; access site related, n=145). Patients with MVC had a significantly higher 3-year mortality than those without MVC (40.8% vs. 24.3%; HR, 2.01; 95% CI: 1.16-3.62). Adjusted 3-year mortality risk was significantly increased in the non-access site-related MVC group (mortality, 77.8%; HR, 4.30; 95% CI: 2.63-7.02), but not in the access site-related MVC group (mortality, 32.6%; HR, 1.38; 95% CI: 0.86-2.15). In the access site-related MVC group, only those with RBC transfusion ≥4 units had a significantly increased 3-year mortality risk (mortality, 51.8%; HR, 2.18; 95% CI: 1.19-3.89). Conclusions: In patients undergoing TF-TAVR, MVC was associated with an increased 3-year mortality risk, incrementally correlating with anatomical site and bleeding severity.