Author + information
- Received May 21, 2018
- Revision received June 28, 2018
- Accepted July 17, 2018
- Published online November 19, 2018.
- Katharina Hellhammer, MDa,
- Kerstin Piayda, MDa,
- Shazia Afzal, MDa,∗ (, )
- Laura Kleinebrecht, MDa,
- Matthias Makosch, BAa,
- Inga Hennig, BAa,
- Christine Quast, MDa,
- Christian Jung, MD, PhDa,
- Amin Polzin, MDa,
- Ralf Westenfeld, MDa,
- Malte Kelm, MDa,b,
- Tobias Zeus, MDa and
- Verena Veulemans, MDa
- aUniversity Hospital Düsseldorf, Medical Faculty, Division of Cardiology, Pulmonology and Vascular Medicine, Düsseldorf, Germany
- bCardiovascular Research Institute Düsseldorf, Düsseldorf, Germany
- ↵∗Address for correspondence:
Dr. Shazia Afzal, Division of Cardiology, Pulmonology and Vascular Medicine, University Hospital Düsseldorf, Moorenstraße 5, 40225 Düsseldorf, Germany.
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.
Drs. Veulemans, Westenfeld, and Zeus have received consulting fees, travel expenses, or study honoraria from Medtronic and Edwards Lifesciences outside of this work. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Drs. Hellhammer and Piayda contributed equally to this work.
- Received May 21, 2018.
- Revision received June 28, 2018.
- Accepted July 17, 2018.
- 2018 American College of Cardiology Foundation