Transapical aortic valve implantation: Incidence and predictors of paravalvular leakage and transvalvular regurgitation in a series of 441 patients

Objectives: The aim of this report was to evaluate the results when the surgical concept of not accepting intra-procedural paravalvular leakage was applied for transcatheter aortic valve implantation (TAVI). Surgical strategy of conventional aortic valve replacement does not accept paraprosthetic leakage and requires immediate action to eliminate it. However, paravalvular leakage is the major concern after TAVI. Methods: A total of 441 patients underwent transapical TAVI with a balloon expandable prosthesis. Our modified procedural strategy consisted of precise positioning of the prosthesis using a modified TAVI technique and immediate additional intra-procedural treatment to eliminate relevant paravalvular leakage. Results: Balloon re-dilatation of the transcatheter valve was performed in 24 (5%) patients, and an additional, second valve was implanted in 16 (4%). At the end of the procedure, 232 (53%) patients had no paravalvular or transvalvular regurgitation. In the remaining 209 patients, paravalvular leakage was observed in 142 (32%), transvalvular in 52 (12%), and both in 16 (3%). It was trace in 111 (25%) patients, mild in 95 (22%), and moderate in 3 (0.7%). Multivariable analysis identified male gender, NYHA-class IV, and no previous aortic valve replacement as predictors for post-procedural leakage. The following morphological constellations were associated with a higher risk for intra-procedural regurgitation: asymmetrically calcified cusps especially in combination with a large annulus size or an oval annulus shape, non-fused commissures in the neighborhood of calcified masses, and the presence of sub-valvular calcification. Cumulative survival was not dependent on post-procedural regurgitation rate. Overall mortality was 5±1% at 1 month, 20±2% at 1 year, 34±3at 2 years, and 38±4% at 3 years. Conclusion: The modified procedural strategy of transapical TAVI with a balloon expandable prosthesis was associated with a low incidence of relevant prosthetic regurgitation.