Efficacy and Safety of Postdilation for a Self-Expanding Transcatheter Heart Valve.

Background: Data are lacking regarding the outcomes of balloon postdilation (BPD) for the Acurate neo and neo2 devices. The aim of this study was to assess the impact of BPD in a large, single-center cohort of patients treated with the Acurate platform.

Methods: For this retrospective analysis, we included all patients with severe aortic stenosis who underwent transfemoral transcatheter aortic valve replacement (TAVR) with the Acurate neo or neo2 prosthesis at our institution.

Results: Among 1417 Acurate recipients, BPD was required in 521 cases (36.8%) for relevant paravalvular regurgitation (PVR) (n = 418) and incomplete prosthesis expansion or increased transprosthetic gradients (n = 103). Overall, BPD was successful in 87.9% and led to a significant reduction of more-than-mild PVR from 32.0% to 7.5% (P<.001). In the BPD group, prosthesis-patient mismatch (PPM) was less common. Prosthetic leaflet damage or valve dislodgment due to BPD occurred in 6 cases (1.2%). All other outcomes were similar between groups with and without BPD, including rates of aortic root injury, stroke, acute kidney injury, permanent pacemaker implantation, and all-cause 30-day mortality. Independent predictors of the need for BPD were higher mean transaortic gradients, severe aortic valve calcification, less prosthesis oversizing, and the use of larger prosthesis sizes.

Conclusion: For transfemoral TAVR using the Acurate neo/neo2, BPD effectively reduces relevant PVR and decreases the risk of PPM without increasing adverse events. Transcatheter heart valve damage associated with BPD is rare, commonly avoidable, and does not jeopardize the net benefit of BPD.