Oliver Husser1, Won-Keun Kim2, Costanza Pellegrini1, Andreas Holzamer3, Thomas Walther4, Patrick N Mayr5, Michael Joner1, Albert M Kasel1, Teresa Trenkwalder1, Jonathan Michel1, Tobias Rheude1, Adnan Kastrati6, Heribert Schunkert6, Christof Burgdorf7, Michael Hilker3, Helge Möllmann2, Christian Hengstenberg8. 1. Klinik für Herz und Kreislauferkrankungen, Deutsches Herzzentrum München, Technical University Munich, Munich, Germany. 2. Department of Cardiology, Kerckhoff Heart and Lung Center, Bad Nauheim, Germany. 3. Klinik für Herz, Thorax, und Herznahe Gefäßchirurgie, University of Regensburg Medical Center, Regensburg, Germany. 4. Department of Cardiovascular Surgery, Kerckhoff Heart and Lung Center, Bad Nauheim, Germany. 5. Institut für Anästhesiologie, Deutsches Herzzentrum München, Technical University Munich, Munich, Germany. 6. Klinik für Herz und Kreislauferkrankungen, Deutsches Herzzentrum München, Technical University Munich, Munich, Germany; Deutsches Zentrum für Herz- und Kreislauf-Forschung (German Center for Cardiovascular Research), Partner Site Munich Heart Alliance, Munich, Germany. 7. Klinik für Herz und Kreislauferkrankungen, Deutsches Herzzentrum München, Technical University Munich, Munich, Germany; Herz und Gefäßzentrum Bad Bevensen, Klinik für Kardiologie, Bad Bevensen, Germany. 8. Klinik für Herz und Kreislauferkrankungen, Deutsches Herzzentrum München, Technical University Munich, Munich, Germany; Deutsches Zentrum für Herz- und Kreislauf-Forschung (German Center for Cardiovascular Research), Partner Site Munich Heart Alliance, Munich, Germany. Electronic address: christian.hengstenberg@gmail.com.
Abstract
OBJECTIVES: This study sought to compare 2 next-generation transcatheter heart valves (THV), the self-expanding ACURATE neo (NEO) and the balloon-expandable SAPIEN 3 (S3), in terms of device failure and early safety at 30 days. BACKGROUND: Deployment of these THV showed promising initial clinical results. However, no comparative data are available. METHODS: Of 1,121 treated patients at 3 centers, a 1-to-2 nearest neighbor matching was performed to identify 2 patients treated with S3 (n = 622) for each patient treated with NEO (n = 311). RESULTS: In-hospital complications were comparable between NEO and S3, including stroke (1.9% vs. 2.4%; p = 0.64), major vascular complications (10.3% vs. 8.5%; p = 0.38), or life-threatening bleeding (4.2% vs. 3.7%; p = 0.72). Device failure with NEO was comparable with S3 (10.9% vs. 9.6%; odds ratio: 1.09 [95% confidence interval: 0.69 to 1.73]; p = 0.71) with more paravalvular leakage (PVL II+, 4.8% vs. 1.8%; p = 0.01), but less elevated gradients (≥20 mm Hg, 3.2% vs. 6.9%; p = 0.02) and pacemaker implantations (9.9% vs. 15.5%; p = 0.02). Thirty-day mortality (2.3% vs. 1.9%; p = 0.74) and the early safety composite endpoint (15.8% vs. 15.6%; hazard ratio: 0.97 [95% confidence interval: 0.68 to 1.39]; p = 0.88) were similar with NEO and S3. CONCLUSIONS: Very high success rates were achieved for both valves, and the clinical and procedural results were comparable. Compared with S3, NEO was associated with less new pacemaker implantations and less elevated gradients, but with more paravalvular leakage.
OBJECTIVES: This study sought to compare 2 next-generation transcatheter heart valves (THV), the self-expanding ACURATE neo (NEO) and the balloon-expandable SAPIEN 3 (S3), in terms of device failure and early safety at 30 days. BACKGROUND: Deployment of these THV showed promising initial clinical results. However, no comparative data are available. METHODS: Of 1,121 treated patients at 3 centers, a 1-to-2 nearest neighbor matching was performed to identify 2 patients treated with S3 (n = 622) for each patient treated with NEO (n = 311). RESULTS: In-hospital complications were comparable between NEO and S3, including stroke (1.9% vs. 2.4%; p = 0.64), major vascular complications (10.3% vs. 8.5%; p = 0.38), or life-threatening bleeding (4.2% vs. 3.7%; p = 0.72). Device failure with NEO was comparable with S3 (10.9% vs. 9.6%; odds ratio: 1.09 [95% confidence interval: 0.69 to 1.73]; p = 0.71) with more paravalvular leakage (PVL II+, 4.8% vs. 1.8%; p = 0.01), but less elevated gradients (≥20 mm Hg, 3.2% vs. 6.9%; p = 0.02) and pacemaker implantations (9.9% vs. 15.5%; p = 0.02). Thirty-day mortality (2.3% vs. 1.9%; p = 0.74) and the early safety composite endpoint (15.8% vs. 15.6%; hazard ratio: 0.97 [95% confidence interval: 0.68 to 1.39]; p = 0.88) were similar with NEO and S3. CONCLUSIONS: Very high success rates were achieved for both valves, and the clinical and procedural results were comparable. Compared with S3, NEO was associated with less new pacemaker implantations and less elevated gradients, but with more paravalvular leakage.
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