Husser, Oliver and Kim, Won-Keun and Pellegrini, Costanza and Holzamer, Andreas and Walther, Thomas and Mayr, Patrick N. and Joner, Michael and Kasel, Albert M. and Trenkwalder, Teresa and Michel, Jonathan and Rheude, Tobias and Kastrati, Adnan and Schunkert, Heribert and Burgdorf, Christof and Hilker, Michael and Moellmann, Helge and Hengstenberg, Christian (2017) Multicenter Comparison of Novel Self-Expanding Versus Balloon-Expandable Transcatheter Heart Valves. JACC-CARDIOVASCULAR INTERVENTIONS, 10 (20). pp. 2078-2087. ISSN 1936-8798, 1876-7605
Full text not available from this repository. (Request a copy)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. (C) 2017 by the American College of Cardiology Foundation.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | INTERMEDIATE-RISK PATIENTS; RANDOMIZED CLINICAL-TRIAL; SEVERE AORTIC-STENOSIS; SAPIEN 3; CONSENSUS DOCUMENT; REPLACEMENT; OUTCOMES; IMPLANTATION; METAANALYSIS; DEFINITIONS; ACURATE neo; SAPIEN 3; transcatheter aortic valve replacement; VARC-2 |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Herz-, Thorax- und herznahe Gefäßchirurgie |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 14 Dec 2018 13:19 |
| Last Modified: | 19 Feb 2019 14:11 |
| URI: | https://pred.uni-regensburg.de/id/eprint/1988 |
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