title: Transcatheter aortic valve implantation of a second-generation valve for pure aortic regurgitation: procedural outcome, haemodynamic data and follow-up.
abstract: OBJECTIVE
  The second-generation Jenavalve prosthesis (Jenavalve Technology, Inc., Munich, Germany) is the first transcatheter valve Conformité Européene (CE) marked for treatment of both aortic stenosis (AS) and pure aortic regurgitation (AR). Although the feasibility of the Jenavalve transcatheter aortic valve implantation (TAVI) in patients with pure AR has been described, haemodynamic and follow-up data are lacking.
  
  
  METHODS
  We report on a series of 10 transapical Jenavalve implantations for pure AR between December 2012 and September 2013. The patients were determined for TAVI by heart team decision at high surgical risk [log EuroSCORE (European System for Cardiac Operative Risk Evaluation) >20%], frailty or Charlson Comorbidity Index (CCI). Transaortic gradients and right heart haemodynamics were measured invasively before and after TAVI. Ventriculography and transoesophageal echocardiography were used to determine paravalvular regurgitation. All-cause mortality, NYHA functional class and echocardiographic measurements were followed up at 30 days and at 3, 9 and 12 months postoperatively.
  
  
  RESULTS
  Overall, mean age was 79 ± 9 years, mean left ventricular ejection fraction 50 ± 17% and mean log EuroSCORE 28.3 ± 17.1%. There were no perioperative complications. Paravalvular regurgitation immediately after implantation was graded none (n = 6), trace (n = 3) or mild (n = 1). Overall 30-day mortality was 30% (3/10). Three patients refused further treatment, such as haemodialysis or treatment of mitral regurgitation. Rate for pacemaker implantation was 2/10 (20%).
  
  
  CONCLUSIONS
  Intraprocedural success and haemodynamic data in our cases were good. The mortality in our group highlighted the importance of careful patient selection, especially for this pathology. The Jenavalve prosthesis proved to be suitable for treatment of AR in surgical high-risk patients.
authors.affiliation: Department of Cardiac Surgery, Asklepios Klinik St. Georg, Hamburg, Germany f.schlingloff@asklepios.com.
authors.forename: Friederike
authors.initials: F
authors.lastname: Schlingloff
authors.affiliation: Department of Cardiology, Asklepios Klinik St. Georg, Hamburg, Germany.
authors.forename: Ulrich
authors.initials: U
authors.lastname: Schäfer
authors.affiliation: Department of Cardiology, Asklepios Klinik St. Georg, Hamburg, Germany.
authors.forename: Christian
authors.initials: C
authors.lastname: Frerker
authors.affiliation: Department of Cardiac Surgery, Asklepios Klinik St. Georg, Hamburg, Germany.
authors.forename: Michael
authors.initials: M
authors.lastname: Schmoeckel
authors.affiliation: Department of Cardiac Surgery, Asklepios Klinik St. Georg, Hamburg, Germany.
authors.forename: Ralf
authors.initials: R
authors.lastname: Bader
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 / Q000379:methods* / Q000401:mortality; D019560:Echocardiography, Three-Dimensional; D017548:Echocardiography, Transesophageal; D005260:Female; 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; D012307:Risk Factors; D013997:Time Factors; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome
keywords: Haemodynamic data; Pure aortic regurgitation; Second-generation valves; Transcatheter valve implantation; VARC-2 Transcatheter aortic valve implantation