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

JACC Cardiovasc Interv. 2014 Oct;7(10):1168-74. doi: 10.1016/j.jcin.2014.05.014. Epub 2014 Aug 13.

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.

Keywords: JenaValve; aortic regurgitation; transapical aortic valve implantation; transcatheter aortic valve implantation.

Publication types

  • Multicenter Study

MeSH terms

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