Ubben, Timm and Tigges, Eike and Kim, Won-Keun and Holzamer, Andreas and Breitenbach, Ingo and Sodian, Ralf and Rothe, Juergen and Hochholzer, Willibald and Hakmi, Samer and Neumann, Franz-Josef (2024) German Experience with a Novel Balloon-Expandable Heart Valve Prosthesis for Transcatheter Aortic Valve Implantation-Outcomes of the MYLAND (MYvaL germAN stuDy) Study. JOURNAL OF CLINICAL MEDICINE, 13 (11): 3163. ISSN 2077-0383
Full text not available from this repository. (Request a copy)Abstract
Background: The primary objective of this study was to evaluate the initial experience in Germany with the Meril Myval (TM) (MM) transcatheter heart valve (THV) system for the treatment of severe symptomatic aortic valve stenosis. The MM THV is a novel balloon-expandable valve with an expanded sizing matrix. Contemporary patients undergoing TAVI with the established Edwards Sapien (TM) (ES) THV served as the comparator group. Methods: Between 1st March and 31 August 2020 a total of 134 patients (33% female, 80.1 +/- 6.7 years; EuroScore II 4.7 +/- 4.8) underwent TAVI with an MM (95% transfemoral) for severe aortic stenosis at six German tertiary care centers. Results: Correct positioning of the THV was achieved in 98.5% (n = 132). Mean aortic gradients (MPG) were reduced from 42 +/- 14 mmHg to 11 +/- 5 mmHg. Mild postprocedural paravalvular leak (PVL) was observed in 62% (n = 82) patients, whereas only one patient had more than mild PVL. New permanent pacemaker implantation (PPI) was indicated in 15 patients (11%). Major vascular complications occurred in 6.7% (n = 9) patients. The in-hospital combined incidence of all-cause death and stroke was 4.5% (n = 6). In the comparator group that included 268 patients, the 30-day incidences of PPI, major vascular complications, and the composite of all-cause death and stroke were 16%, 1.9%, and 7.1%, respectively; MPGs were reduced from 44 +/- 15 mmHg to 12.8 +/- 4.6 mmHg and the more than mild PVL occurred in 0.7%. Conclusions: The MM is a promising novel THV system, with performance comparable to the established ES THVs. These findings await confirmation by ongoing randomized trials.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | REGURGITATION; REPLACEMENT; IMPACT; transcatheter aortic valve replacement; aortic stenosis; self-expanding THV |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Herz-, Thorax- und herznahe Gefäßchirurgie |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 28 Jan 2026 08:45 |
| Last Modified: | 28 Jan 2026 08:45 |
| URI: | https://pred.uni-regensburg.de/id/eprint/65216 |
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