Evaluation of the learning curve for transcatheter aortic valve implantation via the transfemoral approach

Background: The aim of this study was to evaluate the learning curve in performing transfemoral TAVI (TF-TAVI).

Methods: Between October 2006 and October 2013, 312 consecutive TF-TAVI cases performed by 6 interventional cardiologists, using the Edwards Sapien valve and 104 using the CoreValve, were included in the present analysis. Cumulative sum (CUSUM) failure analysis of combined 30-day safety endpoint was used to evaluate learning curves.

Results: The CUSUM analysis revealed a learning curve regarding the occurrence of 30-day adverse events with an improvement after the initial 86 cases using the Edwards valve and 40 cases using the CoreValve. We divided the Edwards valve cases into two groups (early experience: Cases 1 to 86; late experience: Cases 87 to 312). The rate of 30-day mortality and 1-year mortality significantly decreased in the late experience group (17% to 7%, p=0.019; 34% to 21%, p=0.035, respectively). We divided the CoreValve cases into two groups (early experience: Cases 1 to 40; late experience: Cases 41 to 104). The rate of 30-day mortality and 1-year mortality significantly decreased in the late experience group (20% to 6%, p=0.033; 38% to 15%, p=0.040, respectively). The groups including both valves were also analyzed after propensity-matching (early [n=52] vs late [n=52]). This model also showed that 30-day and 1-year mortality rates were significantly lower in the late experience group (13% to 1%, p=0.028; 34% to 20%, p=0.042, respectively).

Conclusions: An appropriate level of experience is needed to reduce the complication rate and mortality in TF-TAVI.