دورية أكاديمية
Transapical Mitral Valve Replacement: 1-Year Results of the Real-World Tendyne European Experience Registry.
| العنوان: | Transapical Mitral Valve Replacement: 1-Year Results of the Real-World Tendyne European Experience Registry. |
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| المؤلفون: | Hell MM; Department of Cardiology, University Medical Center Mainz, Mainz, Germany., Wild MG; Medizinische Klinik I, LMU University Hospital, Munich, Germany., Baldus S; Department of Cardiology, Heart Center, University Hospital Cologne, Cologne, Germany., Rudolph T; Department of Cardiology, Heart- und Diabetes Center Northrhine-Westfalia, Bad Oeynhausen, Ruhr-University Bochum, Bochum, Germany., Treede H; Department of Cardiovascular Surgery, Universitätsmedizin Mainz of the Johannes Gutenberg University, Mainz, Germany., Petronio AS; Cardiothoracic and Vascular Department, University of Pisa, Pisa, Italy., Modine T; CHU Bordeaux, Hopital Cardiologique Haut Leveque, Pessac, France., Andreas M; Department of Cardiac Surgery, Medical University of Vienna, Vienna, Austria., Coisne A; Université de Lille, Inserm, CHU Lille, Institut Pasteur de Lille, Lille, France., Duncan A; Heart Division, Royal Brompton Hospital, London, United Kingdom., Franco LN; Cardiovascular Institute, Hospital Clinico San Carlos, Instituto de Investigación Sanitaria, San Carlos (IdISSC), Madrid, Spain., Praz F; Department of Cardiology, Inselspital University Hospital Bern, Bern, Switzerland., Ruge H; Department of Cardiovascular Surgery, Institute Insure, German Heart Center Munich, School of Medicine & Health, Technical University of Munich, Munich, Germany., Conradi L; University Heart and Vascular Center Hamburg, Hamburg, Germany., Zierer A; Department for Cardiac, Vascular, and Thoracic Surgery, Johannes Kepler University Linz, Kepler University Hospital, Linz, Austria., Anselmi A; Division of Thoracic and Cardiovascular Surgery, University Hospital of Rennes, University of Rennes, Rennes, France., Dumonteil N; Groupe CardioVasculaire Interventionnel, Clinique Pasteur, Toulouse, France., Nickenig G; Heart Center University Hospital, Bonn, Germany., Piñón M; Servicio Cirugía Cardíaca. Hospital Álvaro Cunqueiro, Vigo, Spain., Barth S; Klinik für Kardiologie, Rhön-Klinikum Campus Bad Neustadt, Bad Neustadt an der Saale, Germany., Adamo M; Cardiology, ASST Spedali Civili di Brescia, Department of Medical and Surgical Specialties, Radiological Sciences, and Public Health, University of Brescia, Brescia, Italy., Dubois C; Department of Cardiovascular Medicine, University Hospital Leuven and Department of Cardiovascular Sciences, Leuven, Belgium., Torracca L; IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy., Maisano F; Valve Center, IRCCS Ospedale San Raaffaele and University Vita Salute, Milan, Italy., Lurz P; Department of Cardiology, University Medical Center Mainz, Mainz, Germany; Department of Cardiology, Heart Center Leipzig, Leipzig, Germany., von Bardeleben RS; Department of Cardiology, University Medical Center Mainz, Mainz, Germany. Electronic address: stephan.von_bardeleben@unimedizin-mainz.de., Hausleiter J; Medizinische Klinik I, LMU University Hospital, Munich, Germany; German Center for Cardiovascular Research, partner site Munich Heart Alliance, Munich, Germany. |
| مؤلفون مشاركون: | TENDER Investigators |
| المصدر: | JACC. Cardiovascular interventions [JACC Cardiovasc Interv] 2024 Mar 11; Vol. 17 (5), pp. 648-661. Date of Electronic Publication: 2024 Feb 21. |
| نوع المنشور: | Journal Article |
| اللغة: | English |
| بيانات الدورية: | Publisher: Elsevier Country of Publication: United States NLM ID: 101467004 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1876-7605 (Electronic) Linking ISSN: 19368798 NLM ISO Abbreviation: JACC Cardiovasc Interv Subsets: MEDLINE |
| أسماء مطبوعة: | Original Publication: New York : Elsevier |
| مواضيع طبية MeSH: | Heart Valve Prosthesis Implantation* , Heart Valve Prosthesis*/adverse effects , Mitral Valve Insufficiency*/diagnostic imaging , Mitral Valve Insufficiency*/surgery, Male ; Humans ; Aged ; Female ; Mitral Valve/diagnostic imaging ; Mitral Valve/surgery ; Treatment Outcome ; Cardiac Catheterization/methods ; Registries |
| مستخلص: | Background: Early studies of the Tendyne transcatheter mitral valve replacement (TMVR) showed promising results in a small selective cohort. Objectives: The authors present 1-year data from the currently largest commercial, real-world cohort originating from the investigator-initiated TENDER (Tendyne European Experience) registry. Methods: All patients from the TENDER registry eligible for 1-year follow-up were included. The primary safety endpoint was 1-year cardiovascular mortality. Primary performance endpoint was reduction of mitral regurgitation (MR) up to 1 year. Results: Among 195 eligible patients undergoing TMVR (median age 77 years [Q1-Q3: 71-81 years], 60% men, median Society of Thoracic Surgeons Predicted Risk of Mortality 5.6% [Q1-Q3: 3.6%-8.9%], 81% in NYHA functional class III or IV, 94% with MR 3+/4+), 31% had "real-world" indications for TMVR (severe mitral annular calcification, prior mitral valve treatment, or others) outside of the instructions for use. The technical success rate was 95%. The cardiovascular mortality rate was 7% at 30 day and 17% at 1 year (all-cause mortality rates were 9% and 29%, respectively). Reintervention or surgery following discharge was 4%, while rates of heart failure hospitalization reduced from 68% in the preceding year to 25% during 1-year follow-up. Durable MR reduction to ≤1+ was achieved in 98% of patients, and at 1 year, 83% were in NYHA functional class I or II. There was no difference in survival and major adverse events between on-label use and "real-world" indications up to 1 year. Conclusions: This large, real-world, observational registry reports high technical success, durable and complete MR elimination, significant clinical benefits, and a 1-year cardiovascular mortality rate of 17% after Tendyne TMVR. Outcomes were comparable between on-label use and "real-world" indications, offering a safe and efficacious treatment option for patients without alternative treatments. (Tendyne European Experience Registry [TENDER]; NCT04898335). Competing Interests: Funding Support and Author Disclosures The TENDER study was carried out without financial support from industry. It was initiated as an academic investigator trial by LMU University Hospital and Universitätsmedizin Mainz. Dr Baldus has received research grants and honoraria from Abbott and Edwards Lifesciences. Dr Rudolph has received speaker honoraria from Abbott. Dr Andreas has received proctoring, consulting, and speaker fees from Edwards Lifesciences, Abbott, Medtronic, Boston, Zoll, and AbbVie; and institutional research grants from Edwards Lifesciences, Abbott, Medtronic, and LSI. Dr Duncan has received consulting fees and honoraria from Abbott, Edwards Lifesciences, Medtronic, NeoChord. Dr Nombela serves as a physician proctor for and has received advisory fees from Abbott Cardiovascular, Edwards Lifesciences, and Products + Features. Dr Ruge serves as a physician proctor for and has received advisory fees from Abbott Medical. Dr Conradi serves as an advisory board member for Abbott, Medtronic, and JenaValve; and is a consultant for Edwards Lifesciences, Boston Scientific, MicroPort, Pi-Cardia. Dr Dumonteil has received consulting and proctoring fees from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic. Dr Barth has received speaker and advisory fees from Abbott Cardiovascular and Edwards Lifesciences. Dr Adamo has received speaker honoraria from Abbott, Medtronic, and Edwards Lifesciences. Dr Maisano has received grant and/or research institutional support from Abbott, Medtronic, Edwards Lifesciences, Biotronik, Boston Scientific, New Valve Technology, Terumo, and Venus; has received consulting fees and personal and institutional honoraria from Abbott, Medtronic, Edwards Lifesciences, Xeltis, Cardiovalve, Occlufit, Simulands, MTEX Cardio, Venus, and Squadra; has received royalty income from and holds intellectual property rights with Edwards Lifesciences; is a shareholder (including share options) in CardioGard, Cardiovalve, Magenta, SwissVortex, Transseptal Solutions, 4Tech, and Perifect. Dr Lurz has received honoraria from ReCor Medical and Innoventric; and has received institutional grants from Edwards Lifesciences and ReCor. Dr Hausleiter has received speaker fees, research support, and advisory fees from Edwards Lifesciences. Dr von Bardeleben has received speaker or advisory fees from Abbott Cardiovascular, Edwards Lifesciences, Medtronic, NeoChord, Philips, and Siemens; and has conducted unpaid trial activity for Abbott Cardiovascular, Edwards Lifesciences, Jenscare Scientific, Medtronic, and NeoChord. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.) |
| فهرسة مساهمة: | Investigator: MM Hell; MG Wild; S Baldus; M Adam; T Rudolph; S Bleiziffer; H Treede; TF Ruf; AS Petronio; A Colli; C Giannini; T Modine; G Bonnet; M Andreas; T Kerbel; A Coisne; A Vincentelli; A Duncan; C Quarto; LN Franco; J Cobiella; F Praz; H Ruge; M Krane; L Conradi; S Ludwig; A Zierer; J Kellermair; I Damian; A Anselmi; E Donal; N Dumonteil; P Berthoumieu; G Nickenig; M Piñón; R Estevez; S Barth; W Reents; M Adamo; C Dubois; L Torracca; A Fumero; F Maisano; P Denti; GA Bruxelles; F Maes; F Kreidel; JB Munguira; F Musumeci; M Russo; V Monivas; T Walter; R Gherli; P Lurz; T Noack; J Hausleiter; RS von Bardeleben Keywords: mitral annular calcification; mitral regurgitation; mitral valve; transcatheter mitral valve replacement |
| سلسلة جزيئية: | ClinicalTrials.gov NCT04898335 |
| تواريخ الأحداث: | Date Created: 20240222 Date Completed: 20240315 Latest Revision: 20240315 |
| رمز التحديث: | 20240315 |
| DOI: | 10.1016/j.jcin.2023.12.027 |
| PMID: | 38385922 |
| قاعدة البيانات: | MEDLINE |
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Full Text Finder | تدمد: | 1876-7605 |
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| DOI: | 10.1016/j.jcin.2023.12.027 |