title: Safety and feasibility of a novel adjustable mitral annuloplasty ring: a multicentre European experience.
abstract: OBJECTIVE
  Recurrent mitral regurgitation is a significant problem after mitral valve repair in patients with functional valve disease. We report the safety and feasibility of a novel adjustable mitral annuloplasty device that permits downsizing of the anterior-posterior diameter late after initial surgery.
  
  
  METHODS
  In this multicentre, non-randomized, observational register, patients with moderate or severe mitral regurgitation undergoing surgical mitral valve repair with the MiCardia EnCorSQ™ Mitral Valve Repair system were evaluated. Patient characteristics, operative specifications and results as well as postoperative follow-up were collected for all five centres.
  
  
  RESULTS
  Ninety-four patients with a median age of 71 (64-75) years (EuroSCORE II 6.7 ± 6.3; 66% male, 48% ischaemic MR, 37% dilated cardiomyopathy and 15% degenerative disease) were included. Operative mortality was 1% and the 1-year survival was 93%. Ring adjustment was attempted in 12 patients at a mean interval of 9 ± 6 months after surgery. In three of these attempts, a technical failure occurred. In 1 patient, mitral regurgitation was reduced two grades, in 2 patients mitral regurgitation was reduced one grade and in 6 patients, mitral regurgitation did not change significantly. The mean grade of mitral regurgitation changed from 2.9 ± 0.9 to 2.1 ± 0.7 (P = 0.02). Five patients were reoperated after 11 ± 9 months (Ring dehiscence: 2; failed adjustment: 3).
  
  
  CONCLUSIONS
  We conclude that this device may provide an additional treatment option in patients with functional mitral regurgitation, who are at risk for reoperation due to recurrent mitral regurgitation. Clinical results in this complex disease were ambiguous and patient selection seems to be a crucial step for this device. Further trials are required to estimate the clinical value of this therapeutic concept.
authors.affiliation: Department of Surgery, Division of Cardiac Surgery, Medical University of Vienna, Vienna, Austria martin.andreas@meduniwien.ac.at.
authors.forename: Martin
authors.initials: M
authors.lastname: Andreas
authors.affiliation: Sana Herzchirurgie Stuttgart GmbH, Stuttgart, Germany.
authors.forename: Nicolas
authors.initials: N
authors.lastname: Doll
authors.affiliation: Department of Cardiothoracic Surgery, Southampton General Hospital, Southampton, UK.
authors.forename: Steve
authors.initials: S
authors.lastname: Livesey
authors.affiliation: Department of Cardiovascular Surgery, Institut Clínic del Tòrax, Hospital Clínic, University of Barcelona, Barcelona, Spain.
authors.forename: Manuel
authors.initials: M
authors.lastname: Castella
authors.affiliation: Department of Surgery, Division of Cardiac Surgery, Medical University of Vienna, Vienna, Austria.
authors.forename: Alfred
authors.initials: A
authors.lastname: Kocher
authors.affiliation: Department of Cardiovascular and Thoracic Surgery, OLV Clinic, Aalst, Belgium.
authors.forename: Filip
authors.initials: F
authors.lastname: Casselman
authors.affiliation: Sana Herzchirurgie Stuttgart GmbH, Stuttgart, Germany.
authors.forename: Vladimir
authors.initials: V
authors.lastname: Voth
authors.affiliation: Department of Cardiothoracic Surgery, Southampton General Hospital, Southampton, UK.
authors.forename: Christina
authors.initials: C
authors.lastname: Bannister
authors.affiliation: Department of Cardiovascular Surgery, Institut Clínic del Tòrax, Hospital Clínic, University of Barcelona, Barcelona, Spain.
authors.forename: Juan F
authors.initials: JF
authors.lastname: Encalada Palacios
authors.affiliation: Department of Cardiovascular Surgery, Institut Clínic del Tòrax, Hospital Clínic, University of Barcelona, Barcelona, Spain.
authors.forename: Daniel
authors.initials: D
authors.lastname: Pereda
authors.affiliation: Department of Surgery, Division of Cardiac Surgery, Medical University of Vienna, Vienna, Austria.
authors.forename: Guenther
authors.initials: G
authors.lastname: Laufer
authors.affiliation: Sana Herzchirurgie Stuttgart GmbH, Stuttgart, Germany.
authors.forename: Markus
authors.initials: M
authors.lastname: Czesla
mesh_terms: D000368:Aged; D018450:Disease Progression; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D058386:Mitral Valve Annuloplasty / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods; D008944:Mitral Valve Insufficiency / Q000000981:diagnostic imaging / Q000601:surgery*; D019736:Prostheses and Implants / Q000009:adverse effects; D011474:Prosthesis Design; D011475:Prosthesis Failure; D012086:Reoperation; D016896:Treatment Outcome; D014463:Ultrasonography
keywords: Annuloplasty; Functional mitral regurgitation; Ischaemic mitral regurgitation; Mitral valve reconstruction