title: Initial German experience with transapical implantation of a second-generation transcatheter heart valve for the treatment of aortic regurgitation.
abstract: OBJECTIVE
  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.affiliation: Departments of General and Interventional Cardiology and Cardiovascular Surgery, University Heart Center Hamburg, Hamburg, Germany. Electronic address: m.seiffert@uke.de.
authors.forename: Moritz
authors.initials: M
authors.lastname: Seiffert
authors.affiliation: Departments of Cardiac Surgery and Cardiology, Asklepios Klinik St. Georg, Hamburg, Germany.
authors.forename: Ralf
authors.initials: R
authors.lastname: Bader
authors.affiliation: Department of Cardiac Surgery, University Heart Center Dresden, Dresden, Germany.
authors.forename: Utz
authors.initials: U
authors.lastname: Kappert
authors.affiliation: Department of Cardiovascular Surgery, Cardiovascular Center Rotenburg, Rotenburg a.d. Fulda, Germany.
authors.forename: Ardawan
authors.initials: A
authors.lastname: Rastan
authors.affiliation: Department of Cardiothoracic Surgery, Klinikum Augsburg, Augsburg, Germany.
authors.forename: Stephan
authors.initials: S
authors.lastname: Krapf
authors.affiliation: Department of Cardiovascular Surgery, German Heart Center Munich, Munich, Germany.
authors.forename: Sabine
authors.initials: S
authors.lastname: Bleiziffer
authors.affiliation: Department of Cardiac Surgery, Schüchtermann Klinik Bad Rothenfelde, Bad Rothenfelde, Germany.
authors.forename: Steffen
authors.initials: S
authors.lastname: Hofmann
authors.affiliation: Department of Cardiology, University Hospital Erlangen, Erlangen, Germany.
authors.forename: Martin
authors.initials: M
authors.lastname: Arnold
authors.affiliation: Department of Cardiac Surgery, University Hospital Heidelberg, Heidelberg, Germany.
authors.forename: Klaus
authors.initials: K
authors.lastname: Kallenbach
authors.affiliation: Departments of General and Interventional Cardiology and Cardiovascular Surgery, University Heart Center Hamburg, Hamburg, Germany.
authors.forename: Lenard
authors.initials: L
authors.lastname: Conradi
authors.affiliation: Departments of Cardiac Surgery and Cardiology, Asklepios Klinik St. Georg, Hamburg, Germany.
authors.forename: Friederike
authors.initials: F
authors.lastname: Schlingloff
authors.affiliation: Department of Cardiac Surgery, University Heart Center Dresden, Dresden, Germany.
authors.forename: Manuel
authors.initials: M
authors.lastname: Wilbring
authors.affiliation: Departments of Cardiac Surgery and Cardiology, Asklepios Klinik St. Georg, Hamburg, Germany.
authors.forename: Ulrich
authors.initials: U
authors.lastname: Schäfer
authors.affiliation: Departments of General and Interventional Cardiology and Cardiovascular Surgery, University Heart Center Hamburg, Hamburg, Germany.
authors.forename: Patrick
authors.initials: P
authors.lastname: Diemert
authors.affiliation: Departments of General and Interventional Cardiology and Cardiovascular Surgery, University Heart Center Hamburg, Hamburg, Germany.
authors.forename: Hendrik
authors.initials: H
authors.lastname: Treede
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve / Q000000981:diagnostic imaging / Q000503:physiopathology*; D001022:Aortic Valve Insufficiency / Q000175:diagnosis / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods / Q000401:mortality; D018618:Echocardiography, Doppler, Color; D019560:Echocardiography, Three-Dimensional; D017548:Echocardiography, Transesophageal; D005240:Feasibility Studies; D005260:Female; D005858:Germany; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods / Q000401:mortality; D006439:Hemodynamics; D006801:Humans; D008297:Male; D008875:Middle Aged; D018579:Patient Selection; D011474:Prosthesis Design; D020127:Recovery of Function; D012189:Retrospective Studies; D012307:Risk Factors; D013997:Time Factors; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome
keywords: JenaValve; aortic regurgitation; transapical aortic valve implantation; transcatheter aortic valve implantation