{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,23]],"date-time":"2026-07-23T11:00:18Z","timestamp":1784804418455,"version":"3.55.0"},"reference-count":12,"publisher":"MDPI AG","issue":"11","license":[{"start":{"date-parts":[[2024,5,28]],"date-time":"2024-05-28T00:00:00Z","timestamp":1716854400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Meril Life Sciences Pvt. Ltd."}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JCM"],"abstract":"<jats:p>Background: The primary objective of this study was to evaluate the initial experience in Germany with the Meril Myval\u2122 (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\u2122 (ES) THV served as the comparator group. Methods: Between 1st March and 31 August 2020 a total of 134 patients (33% female, 80.1 \u00b1 6.7 years; EuroScore II 4.7 \u00b1 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 \u00b1 14 mmHg to 11 \u00b1 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 \u00b1 15 mmHg to 12.8 \u00b1 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.<\/jats:p>","DOI":"10.3390\/jcm13113163","type":"journal-article","created":{"date-parts":[[2024,5,28]],"date-time":"2024-05-28T07:38:39Z","timestamp":1716881919000},"page":"3163","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":7,"title":["German Experience with a Novel Balloon-Expandable Heart Valve Prosthesis for Transcatheter Aortic Valve Implantation\u2014Outcomes of the MYLAND (MYvaL germAN stuDy) Study"],"prefix":"10.3390","volume":"13","author":[{"given":"Timm","family":"Ubben","sequence":"first","affiliation":[{"name":"Department of Cardiology, Asklepios Clinic St. Georg, 20099 Hamburg, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0007-4112-3727","authenticated-orcid":false,"given":"Eike","family":"Tigges","sequence":"additional","affiliation":[{"name":"Department of Cardiology, Asklepios Clinic St. Georg, 20099 Hamburg, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0799-7478","authenticated-orcid":false,"given":"Won-Keun","family":"Kim","sequence":"additional","affiliation":[{"name":"Department of Cardiology and Cardiac Surgery, Kerckhoff Heart Center, 61231 Bad Nauheim, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1838-3033","authenticated-orcid":false,"given":"Andreas","family":"Holzamer","sequence":"additional","affiliation":[{"name":"Department of Cardiothoracic Surgery, University of Regensburg Heart Center, 93053 Regensburg, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5308-1655","authenticated-orcid":false,"given":"Ingo","family":"Breitenbach","sequence":"additional","affiliation":[{"name":"Department of Cardiothoracic Surgery and Vascular Surgery, Clinic of Braunschweig, 38120 Braunschweig, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ralf","family":"Sodian","sequence":"additional","affiliation":[{"name":"Department of Cardiovascular Surgery, MediClin Herzzentrum Lahr\/Baden, 77933 Lahr, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0002-5361-3049","authenticated-orcid":false,"given":"J\u00fcrgen","family":"Rothe","sequence":"additional","affiliation":[{"name":"Department of Cardiology and Angiology, Faculty of Medicine, Medical Center\u2014University Heart Freiburg, University of Freiburg, 79189 Bad Krozingen, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Willibald","family":"Hochholzer","sequence":"additional","affiliation":[{"name":"Department of Cardiology and Intensive Care Medicine, Klinikum W\u00fcrzburg Mitte, 97070 W\u00fcrzburg, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Samer","family":"Hakmi","sequence":"additional","affiliation":[{"name":"Department of Cardiothoracic Surgery, Asklepios Clinic St. Georg, 20099 Hamburg, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Franz-Josef","family":"Neumann","sequence":"additional","affiliation":[{"name":"Department of Cardiology and Angiology, Faculty of Medicine, Medical Center\u2014University Heart Freiburg, University of Freiburg, 79189 Bad Krozingen, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2024,5,28]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"160","DOI":"10.1016\/j.jcin.2017.10.014","article-title":"Early Outcomes With the Evolut PRO Repositionable Self-Expanding Transcatheter Aortic Valve With Pericardial Wrap","volume":"11","author":"Forrest","year":"2018","journal-title":"JACC Cardiovasc. 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Cardiol."}],"container-title":["Journal of Clinical Medicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/2077-0383\/13\/11\/3163\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,10]],"date-time":"2025-10-10T14:49:35Z","timestamp":1760107775000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/2077-0383\/13\/11\/3163"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,5,28]]},"references-count":12,"journal-issue":{"issue":"11","published-online":{"date-parts":[[2024,6]]}},"alternative-id":["jcm13113163"],"URL":"https:\/\/doi.org\/10.3390\/jcm13113163","relation":{},"ISSN":["2077-0383"],"issn-type":[{"value":"2077-0383","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,5,28]]}}}