The Effect of Post-Dilatation on Outcomes in the PARTNER 2 SAPIEN 3 Registry

Abstract

ObjectivesThe purpose of this study was to understand the effects of balloon post-dilatation on outcomes following transcatheter aortic valve replacement with the SAPIEN 3 valve. BackgroundHemodynamics and outcomes with balloon post-dilatation for the SAPIEN 3 valve have not been previously reported. MethodsThe effects of balloon post-dilatation (BPD) in 1,661 intermediate (S3i cohort) and high surgical risk (S3HR cohort) patients with aortic stenosis enrolled in the PARTNER (Placement of Aortic Transcatheter Valves) 2, SAPIEN 3 observational study on outcomes, as well as procedural complications, were assessed. Results208 of 1,661 patients (12.5%) had BPD during the initial transcatheter aortic valve replacement. Baseline characteristics were similar except BPD had higher STS score (p < 0.001), significantly less % oversizing (p = 0.004), significantly more ≥moderate left ventricular outflow tract calcification (p = 0.005), and severe annular calcification (p = 0.006). BPD patients had no increase in permanent pacemaker, annular rupture, or valve embolization. Following transcatheter aortic valve replacement, BPD patients had significantly larger aortic valve area (1.72 ± 0.41 cm2 vs. 1.66 ± 0.37 cm2; p = 0.04) with no significant difference in prosthesis–patient mismatch (p = 0.08) or transvalvular aortic regurgitation (p = 0.65), but significantly more paravalvular regurgitation (p < 0.01). There was no significant difference in 30-day or 1-year outcomes of all-cause death (p = 0.65 to 0.76) or stroke (p = 0.28 to 0.72). However, at 1 year, there was a significantly higher incidence of minor stroke in BPD patients (p = 0.02). Adjusting for baseline differences, including calcium burden, minor strokes were no longer significantly different between the BPD and NoBPD groups (p = 0.21). ConclusionsBPD is performed more frequently in patients with lower % oversizing and greater calcium burden. BPD is not associated with procedural complications or an increase in 1-year adverse events of death, rehospitalization, or stroke.