title: Improving mitral valve coaptation with adjustable rings: outcomes from a European multicentre feasibility study with a new-generation adjustable annuloplasty ring system.
abstract: OBJECTIVE
  To evaluate the performance and safety of an adjustable semi-rigid annuloplasty ring for mitral regurgitation (MR) in a multicentre study.
  
  
  METHODS
  Between March 2010 and December 2011, 30 subjects underwent mitral valve (MV) repair using the Cardinal adjustable annuloplasty ring. This device is a semi-rigid ring allowing postimplantation size adjustment, under beating-heart conditions, to optimize leaflet coaptation under echocardiographic guidance. Coaptation length was determined before and after adjustment by transoesophageal echocardiography.
  
  
  RESULTS
  The study enrolled 21 (70%) male and 9 (30%) female subjects with a mean age of 64 years. The approach was conventional midline sternotomy or mini-invasive right thoracotomy. Leaflet resection was done in 17 subjects, and chordal repair was used in 13. Concomitant procedures included coronary artery bypass grafting in 2 (7%) subjects, atrial ablation in 4 (13%) and tricuspid repair in 4 (13%). There was 1 (3%) early death unrelated to the study device. Intraoperative ring adjustment was performed in 24 of the 30 subjects. Residual MR was detected prior to adjustment in 6 subjects (4 mild and 2 moderate MR). Following adjustment, 5 subjects had no MR and 1 had trace MR. After adjustment, mean coaptation length improved from 7 ± 3 to 10 ± 3 mm (P < 0.0001). All patients who completed 1-year follow-up had less-than-mild MR, with the exception of 1 patient with ring dehiscence (and resultant 2+ MR) and 1 functional MR patient who developed recurrent 2+ MR due to persistent leaflet tethering.
  
  
  CONCLUSIONS
  MV repair with the Cardinal adjustable annuloplasty ring is a reliable technique that enables the adjustment of the ring diameter on a beating heart under echocardiographic control. Such technology allows the optimization of leaflet coaptation, providing minimal residual MR and durable repair.
authors.affiliation: San Raffaele University Hospital, Milan, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Maisano
authors.forename: Volkmar
authors.initials: V
authors.lastname: Falk
authors.forename: Michael A
authors.initials: MA
authors.lastname: Borger
authors.forename: Hugo
authors.initials: H
authors.lastname: Vanermen
authors.forename: Ottavio
authors.initials: O
authors.lastname: Alfieri
authors.forename: Joerg
authors.initials: J
authors.lastname: Seeburger
authors.forename: Stefan
authors.initials: S
authors.lastname: Jacobs
authors.forename: Michael
authors.initials: M
authors.lastname: Mack
authors.forename: Friederich W
authors.initials: FW
authors.lastname: Mohr
mesh_terms: D000368:Aged; D017548:Echocardiography, Transesophageal; D005060:Europe; D005240:Feasibility Studies; D005260:Female; D006350:Heart Valve Prosthesis / Q000009:adverse effects / Q000706:statistics & numerical data*; D006801:Humans; D008297:Male; D008875:Middle Aged; D008943:Mitral Valve / Q000000981:diagnostic imaging / Q000601:surgery*; D058386:Mitral Valve Annuloplasty / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods; D011446:Prospective Studies; D019651:Plastic Surgery Procedures; D025321:Surgery, Computer-Assisted; D016896:Treatment Outcome
keywords: Annuloplasty; Coaptation length; Echocardiography; Image-guided surgery; Mitral valve; Reconstruction; Repair