The impact of integration of a multidetector computed tomography annulus area sizing algorithm on outcomes of transcatheter aortic valve replacement: a prospective, multicenter, controlled trial.

Abstract

This study prospectively investigated the impact of integration of a multidetector computed tomography (MDCT) annular area sizing algorithm on transcatheter aortic valve replacement (TAVR) outcomes. Appreciation of the 3-dimensional, noncircular geometry of the aortic annulus is important for transcatheter heart valve (THV) sizing. Patients being evaluated for TAVR in 4 centers underwent pre-procedural MDCT. Recommendations for balloon-expandable THV size selection were based on an MDCT sizing algorithm with an optimal goal of modest annulus area oversizing (5% to 10%). Consecutive patients who underwent TAVR with the algorithm (MDCT group) were compared with consecutive patients without the algorithm (control group). The primary endpoint was the incidence of more than mild paravalvular regurgitation (PAR), and the secondary endpoint was the composite of in-hospital death, aortic annulus rupture, and severe PAR. Of 266 patients, 133 consecutive patients underwent TAVR (SAPIEN XT THV) in the MDCT group and 133 consecutive patients were in the control group. More than mild PAR was present in 5.3% (7 of 133) of the MDCT group and in 12.8% (17 of 133) in the control group (p = 0.032). The combined secondary endpoint occurred in 3.8% (5 of 133) of the MDCT group and in 11.3% (15 of 133) of the control group (p = 0.02), driven by the difference of severe PAR. The implementation of an MDCT annulus area sizing algorithm for TAVR reduces PAR. Three-dimensional aortic annular assessment and annular area sizing should be considered for TAVR.