Pellegrini, Costanza and Kim, Won-Keun and Holzamer, Andreas and Walther, Thomas and Mayr, N. Patrick and Michel, Jonathan and Rheude, Tobias and Nunez, Julio and Kasel, Albert M. and Trenkwalder, Teresa and Kaess, Bernhard M. and Joner, Michael and Kastrati, Adnan and Schunkert, Heribert and Hilker, Michael and Moellmann, Helge and Hengstenberg, Christian and Husser, Oliver (2019) Multicenter Evaluation of Prosthesis Oversizing of the SAPIEN 3 Transcatheter Heart Valve. Impact on Device Failure and New Pacemaker Implantations. REVISTA ESPANOLA DE CARDIOLOGIA, 72 (8). pp. 641-648. ISSN 0300-8932, 1579-2242
Full text not available from this repository. (Request a copy)Abstract
Introduction and objectives: A certain degree of prosthesis oversizing (OS) is recommended for the SAPIEN 3 to achieve device success. However, an increase in OS may increase permanent pacemaker implantation (PPI) rates. We therefore investigated the influence of OS on device failure and PPI. Methods: A total of 804 patients were treated with SAPIEN 3 at 3 centers. Multislice computed tomography-derived OS was calculated and analyzed both as a continuous variable and categorized in 5% increments with -4% to 0% as reference. Results: Device failure occurred in 8.8% of patients. Median OS was lower in patients with device failure vs those with device success (+4% vs +8%; P = .038). A nonlinear risk pattern was shown for OS with a significantly reduced device failure rate within 4% to +22% of OS. There was no case of paravalvular leakage II+ between +10% to +20% of OS. The overall PPI rate was 16.2% and the median OS was significantly larger in patients with PPI (PPI: +9% vs no PPI: +7%; P = .025), while implantation depth did not vary in patients with vs without PPI (6.9 +/- 1.7 mm vs 6.6 +/- 1.9 mm; P = .101). The risk of PPI increased with increasing OS and was highest in the 2 highest categories. Conclusions: An increase in OS reduces the risk for device failure but increases the risk for PPI. There was no ideal range of OS to minimize both device failure and PPI. (C) 2018 Sociedad Espanola de Cardiologia. Published by Elsevier Espana, S.L.U. All rights reserved.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | CONSENSUS DOCUMENT; CLINICAL-OUTCOMES; HIGH-RISK; REPLACEMENT; PREDICTORS; REGURGITATION; Transcatheter aortic valve implantation; Sizing; Pacemaker; Device failure |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Herz-, Thorax- und herznahe Gefäßchirurgie |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 01 Apr 2020 08:03 |
| Last Modified: | 01 Apr 2020 08:03 |
| URI: | https://pred.uni-regensburg.de/id/eprint/26477 |
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