Katharina Hellhammer1, Kerstin Piayda1, Shazia Afzal2, Laura Kleinebrecht1, Matthias Makosch1, Inga Hennig1, Christine Quast1, Christian Jung1, Amin Polzin1, Ralf Westenfeld1, Malte Kelm3, Tobias Zeus1, Verena Veulemans1. 1. University Hospital Düsseldorf, Medical Faculty, Division of Cardiology, Pulmonology and Vascular Medicine, Düsseldorf, Germany. 2. University Hospital Düsseldorf, Medical Faculty, Division of Cardiology, Pulmonology and Vascular Medicine, Düsseldorf, Germany. Electronic address: shazia.afzal@med.uni-duesseldorf.de. 3. University Hospital Düsseldorf, Medical Faculty, Division of Cardiology, Pulmonology and Vascular Medicine, Düsseldorf, Germany; Cardiovascular Research Institute Düsseldorf, Düsseldorf, Germany.
Abstract
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.
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.
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Authors: E A Ovcharenko; K U Klyshnikov; A A Shilov; N A Kochergin; M A Rezvova; N V Belikov; V I Ganyukov Journal: Sovrem Tekhnologii Med Date: 2021-06-28
Authors: H G Kroon; L van Gils; F Ziviello; M P H van Wiechen; J F W Ooms; Z Rahhab; N El Faquir; A-M Maugenest; J A Goudzwaard; P Cummins; M Lenzen; I Kardys; J Daemen; F Mattace-Raso; P P T de Jaegere; N M Van Mieghem Journal: Neth Heart J Date: 2021-04-29 Impact factor: 2.380
Authors: Verena Veulemans; Oliver Maier; Kerstin Piayda; Kira Lisanne Berning; Stephan Binnebößel; Amin Polzin; Shazia Afzal; Lisa Dannenberg; Patrick Horn; Christian Jung; Ralf Westenfeld; Malte Kelm; Tobias Zeus Journal: Clin Res Cardiol Date: 2021-06-24 Impact factor: 5.460