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

Abstract

Aims: To identify predictors of paravalvular regurgitation (PVR) and permanent pacemaker implantation (PPI) following TAVR with a next-generation self-expanding device.

Methods and results: 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 ± 151 mm³; P < 0.001) was significantly higher in patients with PVR ≥ mild. On multivariate analysis, calcification of the aortic valve cusps (AVC) > 410.6 mm³ 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 > 41.4 mm³ in the sector below the left coronary cusp (LVOT_LC) was associated with increased PPI risk (26.9 vs. 7.7%; P = 0.008).

Conclusions: The quantity of AVC calcium predicts residual PVR. Multivariable analysis identified LVOT_LC calcium, pre-existing RBBB, and age > 82.7 years 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%.

Keywords: ACURATE neo TF; Calcium distribution; Paravalvular regurgitation; Permanent pacemaker implantation; Prediction of risk; Transcatheter aortic valve replacement.