Author + information
- Received January 17, 2017
- Revision received June 9, 2017
- Accepted June 15, 2017
- Published online October 16, 2017.
- Oliver Husser, MD, PhDa,
- Won-Keun Kim, MDb,
- Costanza Pellegrini, MDa,
- Andreas Holzamer, MDc,
- Thomas Walther, MDd,
- Patrick N. Mayr, MDe,
- Michael Joner, MDa,
- Albert M. Kasel, MDa,
- Teresa Trenkwalder, MDa,
- Jonathan Michel, MBBS, BSca,
- Tobias Rheude, MDa,
- Adnan Kastrati, MDa,f,
- Heribert Schunkert, MDa,f,
- Christof Burgdorf, MDa,g,
- Michael Hilker, MDc,
- Helge Möllmann, MDb and
- Christian Hengstenberg, MDa,f,∗ ()
- aKlinik für Herz und Kreislauferkrankungen, Deutsches Herzzentrum München, Technical University Munich, Munich, Germany
- bDepartment of Cardiology, Kerckhoff Heart and Lung Center, Bad Nauheim, Germany
- cKlinik für Herz, Thorax, und Herznahe Gefäßchirurgie, University of Regensburg Medical Center, Regensburg, Germany
- dDepartment of Cardiovascular Surgery, Kerckhoff Heart and Lung Center, Bad Nauheim, Germany
- eInstitut für Anästhesiologie, Deutsches Herzzentrum München, Technical University Munich, Munich, Germany
- fDeutsches Zentrum für Herz- und Kreislauf-Forschung (German Center for Cardiovascular Research), Partner Site Munich Heart Alliance, Munich, Germany
- gHerz und Gefäßzentrum Bad Bevensen, Klinik für Kardiologie, Bad Bevensen, Germany
- ↵∗Address for correspondence:
Prof. Dr. med Christian Hengstenberg, Klinik für Herz- und Kreislauferkrankungen–Deutsches Herzzentrum München, Technische Universität München, Lazarettstrasse 36, 80636 Munich, Germany.
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.
Dr. Husser has received minor travel grants from Edwards Lifesciences and Symetis S.A.; and proctor fees from Symetis S.A. Dr. Kim is a proctor for and has received minor lecturing fees from Symetis S.A. and St. Jude Medical. Dr. Pellegrini has received minor travel grants from Edwards Lifesciences. Dr. Kasel has received proctor fees and speaker honoraria from Edwards Lifesciences. Dr. Burgdorf has received proctor fees from Symetis S.A. Dr. Hilker has received proctor fees from Symetis S.A. Dr. Möllmann has received proctor fees and speaker honoraria from Edwards Lifesciences, Symetis S.A., and St. Jude Medical. Dr. Hengstenberg has received proctor fees and speaker honoraria from Edwards Lifesciences and Symetis S.A. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received January 17, 2017.
- Revision received June 9, 2017.
- Accepted June 15, 2017.
- 2017 American College of Cardiology Foundation