title: Geometric ring annuloplasty as an adjunct to aortic valve repair: clinical investigation of the HAART 300 device.
abstract: OBJECTIVE
  This study assessed the safety and efficacy of an internal geometric annuloplasty ring in a regulatory trial of aortic valve reconstruction (ClinicalTrials.gov Identifier: NCT01400841).
  
  
  METHODS
  Sixty-five patients with predominant moderate-to-severe trileaflet aortic insufficiency (AI) underwent aortic valve repair with an average age of 63 ± 13 years (mean ± SD). All had initial implantation of an internal aortic annuloplasty ring to correct annular dilatation and facilitate leaflet reconstruction. Leaflet plication was performed for prolapse in 80% of patients, and more complex leaflet procedures, usually employing autologous pericardium, were required in 22%. Ascending aortic and/or root aneurysms were replaced in 62%.
  
  
  RESULTS
  Follow-up was for a maximum of 3 years and a mean of 2 years. No in-hospital operative mortalities, major complications or early or late valve-related events occurred. The annular diameter before repair was 26.5 ± 2.3 mm, and the average ring diameter used was 21.5 ± 1.6 mm. The preoperative AI grade (0-4) was 2.9 ± 0.8 and improved after repair to 0.6 ± 0.7 (P < 0.0001), as did the NYHA class. The mean valve gradient was 8.6 ± 4.3 mmHg, and at 3 years, the Kaplan-Meier survival rate was 95%, with no valve-related mortality. Over the 3 years, aortic valve replacement was required in 7 patients (10.8%) for reasons usually related to surgical technique. Most repair failures occurred early, and results stabilized after 6 months. No structural complications of the rings were observed.
  
  
  CONCLUSIONS
  Geometric ring annuloplasty was a safe and effective adjunct to aortic valve repair. Initial correction of annular dilatation seemed to facilitate overall reconstruction. Because most early repair failures were technical, increasing experience with geometric ring annuloplasty for aortic valve reconstruction has the potential to standardize and improve outcomes.
authors.affiliation: Department of Cardiovascular Surgery, Deutsches Herzzentrum München, Munich, Germany.
authors.forename: Domenico
authors.initials: D
authors.lastname: Mazzitelli
authors.affiliation: Department of Cardiovascular Surgery, Klinikum Nürnberg, Paracelsus Medical University, Nuremberg, Germany.
authors.forename: Theodor
authors.initials: T
authors.lastname: Fischlein
authors.affiliation: Cardiothoracic Surgery Associates, Nashville, TN, USA jsrankinmd@cs.com.
authors.forename: J Scott
authors.initials: JS
authors.lastname: Rankin
authors.affiliation: Department of Cardiac and Thoracic Surgery, University of Köln, Cologne, Germany.
authors.forename: Yeong-Hoon
authors.initials: YH
authors.lastname: Choi
authors.affiliation: Department of Cardiac Surgery, Deutsches Herzzentrum Berlin, Berlin, Germany.
authors.forename: Christof
authors.initials: C
authors.lastname: Stamm
authors.affiliation: Department of Cardiovascular Surgery, Klinikum Nürnberg, Paracelsus Medical University, Nuremberg, Germany.
authors.forename: Steffen
authors.initials: S
authors.lastname: Pfeiffer
authors.affiliation: Department of Cardiac Surgery, Institute for Clinical and Experimental Medicine, Prague, Czech Republic.
authors.forename: Jan
authors.initials: J
authors.lastname: Pirk
authors.affiliation: Department of Cardiovascular Surgery, University Heart Center, Hamburg, Germany.
authors.forename: Christian
authors.initials: C
authors.lastname: Detter
authors.affiliation: Department of Cardiovascular Surgery, Albert-Ludwigs University, Freiburg, Germany.
authors.forename: Johannes
authors.initials: J
authors.lastname: Kroll
authors.affiliation: Department of Cardiovascular Surgery, Albert-Ludwigs University, Freiburg, Germany.
authors.forename: Friedhelm
authors.initials: F
authors.lastname: Beyersdorf
authors.affiliation: BioStable Science and Engineering, Inc., Austin, TX, USA.
authors.forename: Charles D
authors.initials: CD
authors.lastname: Griffin
authors.affiliation: Department of Cardiothoracic Surgery, Hannover Medical School, Hannover, Germany.
authors.forename: Malakh
authors.initials: M
authors.lastname: Shrestha
authors.affiliation: Department of Cardiovascular Surgery, Deutsches Herzzentrum München, Munich, Germany.
authors.forename: Christian
authors.initials: C
authors.lastname: Nöbauer
authors.affiliation: Department of Mathematics, Vanderbilt University, Nashville, TN, USA.
authors.forename: Philip S
authors.initials: PS
authors.lastname: Crooke
authors.affiliation: Department of Cardiovascular Surgery, Deutsches Herzzentrum München, Munich, Germany.
authors.forename: Christian
authors.initials: C
authors.lastname: Schreiber
authors.affiliation: Department of Cardiovascular Surgery, Deutsches Herzzentrum München, Munich, Germany.
authors.forename: Rüdiger
authors.initials: R
authors.lastname: Lange
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve / Q000601:surgery*; D001022:Aortic Valve Insufficiency / Q000601:surgery*; D058385:Cardiac Valve Annuloplasty / Q000009:adverse effects* / Q000295:instrumentation* / Q000379:methods / Q000401:mortality; D005260:Female; D006350:Heart Valve Prosthesis / Q000009:adverse effects*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012086:Reoperation
keywords: Aortic annuloplasty; Aortic insufficiency; Aortic valve repair