Initial Multicenter Experience With a Novel Self-Expanding TAVR System in Patients With Aortic Valve Stenosis

Tamm AR, Wienemann H, Treede H, Geyer M, Arnold M, Marwan M, Theiss H, Braun D, Bleiziffer S, Goncharov A, Kuhn E, von Bardeleben RS, Achenbach S, Massberg S, Baldus S, Adam M, Rudolph TK (2025)

Publication Type: Journal article

Publication year: 2025

Journal

Jacc-Cardiovascular Interventions Elsevier

Book Volume: 18

Pages Range: 60-68

Journal Issue: 1

DOI: 10.1016/j.jcin.2024.10.056

Abstract

Background: As transcatheter aortic valve replacement is performed increasingly in younger, low-risk patients, the need for commissural alignment and coronary access has increased. Design elements of the JenaValve Trilogy (JVT) transcatheter heart valve (THV) ensure both. Objectives: This study sought to evaluate the outcome of patients with aortic stenosis (AS) treated with this novel transfemoral, self-expanding THV. Methods: We included 43 consecutive patients with severe AS treated with the JVT system at 5 German sites. The primary endpoint of the study was technical success of the procedure. Procedural outcomes, hemodynamic valve performance, and clinical outcomes at 30 days were evaluated according to the Valve Academic Research Consortium-3 criteria. Results: The median age was 81 years (Q1-Q3: 77.0-83.9 years) with a median Society of Thoracic Surgeons Risk Score of 3.1% (Q1-Q3: 2.1%-5.9%). Technical success was achieved in 98% (n = 42 of 43). One patient was converted to open surgery. The median aortic gradient was 5.0 mm Hg (Q1-Q3: 4.0-7.0 mm Hg), and no patient had moderate or greater paravalvular regurgitation (88% [n = 37 of 42] with none or trace paravalvular regurgitation). At 30 days, major vascular complications and stroke each occurred in 1 (2.3%) patient, 2 (4.7%) patients had died, and permanent pacemaker implantation was needed in 4.9% (n = 2 of 41). Overall, early safety at 30 days was achieved in 82% (n = 27 of 33) of patients. Conclusions: Treatment of AS patients with this novel transfemoral THV system is safe and effective. The JVT offers an excellent alternative to established transcatheter aortic valve replacement prostheses for patients with AS.

Authors with CRIS profile

Martin Arnold Department of Medicine 2 – Cardiology and Angiology Mohamed Marwan Department of Medicine 2 – Cardiology and Angiology Stephan Achenbach Lehrstuhl für Innere Medizin II

Involved external institutions

Johannes Gutenberg-Universität Mainz (JGU) DE Germany (DE) Universitätsmedizin der Johannes Gutenberg-Universität Mainz DE Germany (DE) Herz- und Diabeteszentrum Nordrhein-Westfalen DE Germany (DE) Universitätsklinikum Köln DE Germany (DE) Klinikum der Universität München DE Germany (DE)

How to cite

APA:

Tamm, A.R., Wienemann, H., Treede, H., Geyer, M., Arnold, M., Marwan, M.,... Rudolph, T.K. (2025). Initial Multicenter Experience With a Novel Self-Expanding TAVR System in Patients With Aortic Valve Stenosis. Jacc-Cardiovascular Interventions, 18(1), 60-68. https://doi.org/10.1016/j.jcin.2024.10.056

MLA:

Tamm, Alexander R., et al. "Initial Multicenter Experience With a Novel Self-Expanding TAVR System in Patients With Aortic Valve Stenosis." Jacc-Cardiovascular Interventions 18.1 (2025): 60-68.

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