The Latest Evolution of the Medtronic CoreValve System in the Era of Transcatheter Aortic Valve Replacement: Matched Comparison of the Evolut PRO and Evolut R.

Objectives: The aim of this study was to investigate the hemodynamic and clinical performance of the Evolut PRO compared with its direct predecessor, the Evolut R.

Background: Recently, the newest commercially available generation of the self-expandable Medtronic CoreValve prosthesis, the CoreValve Evolut PRO, was introduced to the market. This prosthesis is based on the previous Evolut R model and specifically designed to mitigate paravalvular leakage. Because of the design changes, the Evolut PRO needs a larger sheath size (16-F vs. 14-F).

Methods: Patients receiving either the Evolut R (n = 148) or the Evolut PRO (n = 74) from September 2015 to January 2018 were compared in a 2:1 fashion after propensity score matching. Baseline characteristics, cardiovascular imaging, and pre- and periprocedural outcomes were prospectively collected and assessed.

Results: Both cohorts represent a high-risk, real-world collective with increased perioperative mortality risk (logistic European System for Cardiac Operative Risk Evaluation score, Evolut R vs. Evolut PRO: 24.7 ± 13.7% vs. 25.1 ± 12.5%; p = 0.881). Procedural success was 100%, and the mean transvalvular pressure gradient was substantially reduced (Evolut R vs. Evolut PRO: 7.9 ± 3.9 mm Hg vs. 7.5 ± 3.5 mm Hg; p = 0.348). Mild paravalvular leakage was observed in 16.2% of Evolut R patients and in 14.9% of Evolut PRO patients (p = 0.794). In the Evolut R group, moderate aortic regurgitation was documented in 2 patients (Evolut R vs. Evolut PRO: 1.4% vs. 0%; p = 1.000). No differences regarding clinical parameters, such as major bleeding events (Evolut R vs. Evolut PRO: 1.4% vs.1.3%; p = 0.868) and vascular complications were observed.

Conclusions: Both prostheses show excellent hemodynamic performance with a low incidence of paravalvular leakage and comparable clinical outcomes.