title: Transapical implantation of a second-generation transcatheter heart valve in patients with noncalcified aortic regurgitation.
abstract: OBJECTIVE
  This study sought to report on the feasibility and early results of transcatheter aortic valve implantation employing a second-generation device in a series of patients with pure aortic regurgitation.
  
  
  BACKGROUND
  Efficacy and safety of transcatheter aortic valve implantation in patients with calcific aortic stenosis and high surgical risk has been demonstrated. However, experience with implantation for severe noncalcified aortic regurgitation has been limited due to increased risk for valve dislocation or annular rupture.
  
  
  METHODS
  Five patients (mean age: 66.6 ± 7 years) underwent transapical implantation of a JenaValve (JenaValve Technology GmbH, Munich, Germany) transcatheter heart valve for moderate to severe, noncalcified aortic regurgitation. All patients were considered high risk for surgical aortic valve replacement after evaluation by an interdisciplinary heart team (logistic EuroSCORE [European System for Cardiac Operative Risk Evaluation] range 3.1% to 38.9%). Procedural and acute clinical outcomes were analyzed.
  
  
  RESULTS
  Implantation was successful in all cases without relevant remaining aortic regurgitation or signs of stenosis in any of the patients. No major device- or procedure-related adverse events occurred and all 5 patients were alive with improved exercise tolerance at 3-month follow-up.
  
  
  CONCLUSIONS
  Noncalcified aortic regurgitation continues to be a challenging pathology for transcatheter aortic valve implantation due to the risk for insufficient anchoring of the valve stent within the aortic annulus. This report provides first evidence that the JenaValve prosthesis may be a reasonable option in these specific patients due to its unique stent design, clipping the native aortic valve leaflets, and offering promising early results.
authors.affiliation: Department of Cardiovascular Surgery, University Heart Center Hamburg, Hamburg, Germany. m.seiffert@uke.de
authors.forename: Moritz
authors.initials: M
authors.lastname: Seiffert
authors.forename: Patrick
authors.initials: P
authors.lastname: Diemert
authors.forename: Dietmar
authors.initials: D
authors.lastname: Koschyk
authors.forename: Johannes
authors.initials: J
authors.lastname: Schirmer
authors.forename: Lenard
authors.initials: L
authors.lastname: Conradi
authors.forename: Renate
authors.initials: R
authors.lastname: Schnabel
authors.forename: Stefan
authors.initials: S
authors.lastname: Blankenberg
authors.forename: Hermann
authors.initials: H
authors.lastname: Reichenspurner
authors.forename: Stephan
authors.initials: S
authors.lastname: Baldus
authors.forename: Hendrik
authors.initials: H
authors.lastname: Treede
mesh_terms: D000368:Aged; D001022:Aortic Valve Insufficiency / Q000175:diagnosis / Q000628:therapy*; D006328:Cardiac Catheterization / Q000295:instrumentation*; D018618:Echocardiography, Doppler, Color; D005240:Feasibility Studies; D005260:Female; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000295:instrumentation* / Q000379:methods; D006801:Humans; D008297:Male; D008875:Middle Aged; D011474:Prosthesis Design; D012720:Severity of Illness Index; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome