The Latest Evolution of the Medtronic CoreValve System in the Era of Transcatheter Aortic Valve Replacement

• Published in: JACC. Cardiovascular interventions 2018-11, Vol.11 (22), p.2314-2322
• Main Authors: Hellhammer, Katharina, Piayda, Kerstin, Afzal, Shazia, Kleinebrecht, Laura, Makosch, Matthias, Hennig, Inga, Quast, Christine, Jung, Christian, Polzin, Amin, Westenfeld, Ralf, Kelm, Malte, Zeus, Tobias, Veulemans, Verena
• Format: Article
• Language: English
• Subjects: aortic regurgitation; CoreValve Evolut PRO; CoreValve Evolut R; paravalvular leakage; TAVR
• ISSN: 1936-8798; 1876-7605
• DOI: 10.1016/j.jcin.2018.07.023

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. 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). 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. 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. Both prostheses show excellent hemodynamic performance with a low incidence of paravalvular leakage and comparable clinical outcomes. [Display omitted]