Initial German experience with transapical implantation of a second-generation transcatheter heart valve for the treatment of aortic regurgitation.

Abstract

OBJECTIVES:

This analysis reports on the initial German multicenter experience with the JenaValve (JenaValve Technology GmbH, Munich, Germany) transcatheter heart valve for the treatment of pure aortic regurgitation.

BACKGROUND:

Experience with transcatheter aortic valve implantation (TAVI) for severe aortic regurgitation is limited due to the risk of insufficient anchoring of the valve stent within the noncalcified aortic annulus.

METHODS:

Transapical TAVI with a JenaValve for the treatment of severe aortic regurgitation was performed in 31 patients (age 73.8 ± 9.1 years) in 9 German centers. All patients were considered high risk for surgery (logistic EuroSCORE [European System for Cardiac Operative Risk Evaluation] 23.6 ± 14.5%) according to a local heart team consensus. Procedural results and clinical outcomes up to 6 months were analyzed.

RESULTS:

Implantation was successful in 30 of 31 cases (aortic annulus diameter 24.7 ± 1.5 mm); transcatheter heart valve dislodgement necessitated valve-in-valve implantation in 1 patient. Post-procedural aortic regurgitation was none/trace in 28 of 31 and mild in 3 of 31 patients. During follow-up, 2 patients underwent valvular reinterventions (surgical aortic valve replacement for endocarditis, valve-in-valve implantation for increasing paravalvular regurgitation). All-cause mortality was 12.9% and 19.3% at 30 days and 6 months, respectively. In the remaining patients, a significant improvement in New York Heart Association class was observed and persisted up to 6 months after TAVI.

CONCLUSIONS:

Aortic regurgitation remains a challenging pathology for TAVI. After initial demonstration of feasibility, this multicenter study revealed the JenaValve transcatheter heart valve as a reasonable option in this subset of patients. However, a significant early noncardiac mortality related to the high-risk population emphasizes the need for careful patient selection.

• Authors: Moritz Seiffert, Ralf Bader, Utz Kappert, Ardawan Rastan, Stephan Krapf, Sabine Bleiziffer, Steffen Hofmann, Martin Arnold, Klaus Kallenbach, Lenard Conradi, Friederike Schlingloff, Manuel Wilbring, Ulrich Schäfer, Patrick Diemert, Hendrik Treede
• Journal: JACC. Cardiovascular interventions (JACC Cardiovasc Interv) Vol. 7 Issue 10 Pg. 1168-74 (Oct 2014) ISSN: 1876-7605 [Electronic] United States
• PMID: 25129672 (Publication Type: Journal Article, Multicenter Study)
• Copyright: Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Topics

• Aged
• Aged, 80 and over
• Aortic Valve (diagnostic imaging, physiopathology)
• Aortic Valve Insufficiency (diagnosis, mortality, physiopathology, therapy)
• Cardiac Catheterization (adverse effects, instrumentation, methods, mortality)
• Echocardiography, Doppler, Color
• Echocardiography, Three-Dimensional
• Echocardiography, Transesophageal
• Feasibility Studies
• Female
• Germany
• Heart Valve Prosthesis
• Heart Valve Prosthesis Implantation (adverse effects, instrumentation, methods, mortality)
• Hemodynamics
• Humans
• Male
• Middle Aged
• Patient Selection
• Prosthesis Design
• Recovery of Function
• Retrospective Studies
• Risk Factors
• Time Factors
• Tomography, X-Ray Computed
• Treatment Outcome