Predictors of paravalvular regurgitation and permanent pacemaker implantation after TAVR with a next-generation self-expanding device.

Abstract

To identify predictors of paravalvular regurgitation (PVR) and permanent pacemaker implantation (PPI) following TAVR with a next-generation self-expanding device. Device landing zone (DLZ) calcification, angiographic implantation depth, and baseline and procedural characteristics were analyzed in 212 patients being treated with the ACURATE neo aortic bioprosthesis. PVR was none/trace in 57.1% and ≥ mild in 42.9% (37% mild, 6% moderate). DLZ calcification (705 (IQR 240-624) vs. 382 (IQR 240-624)mm3; P < 0.001) as well as absolute calcium asymmetry (233 ± 159 vs. 151 ± 151mm3; P < 0.001) was significantly higher in patients with PVR ≥ mild. On multivariate analysis, calcification of the aortic valve cusps (AVC) > 410.6mm3 was independently associated with PVR ≥ mild. PPI rate was 10.3% (n = 20). Patients with and without need for PPI had similar total DLZ calcium volume (740 (IQR 378-920) vs. 536 (IQR 315-822)mm3; P = 0.263), but exhibited different calcium distribution patterns: LVOT calcium > 41.4mm3 in the sector below the left coronary cusp (LVOTLC) was associated with increased PPI risk (26.9 vs. 7.7%; P = 0.008). The quantity of AVC calcium predicts residual PVR. Multivariable analysis identified LVOTLC calcium, pre-existing RBBB, and age > 82.7years as independent predictors of PPI. Based on these risk factors, a patient's individual PPI risk can be stratified ranging from 3.8 to 100%.