title: Results of mitral valve repair with an adjustable annuloplasty ring 2 years after implantation.
abstract: We aimed to investigate the safety and medium-term durability of an adjustable mitral annuloplasty ring in patients undergoing surgery for mitral valve regurgitation. Forty-five patients requiring mitral valve repair were enrolled into this prospective, multicentre study between May 2012 and May 2013 in six hospitals in Europe and Israel. Study endpoints evaluated the performance and safety of the device assessed using inter-individual comparisons. Implantation was performed through a sternotomy in ten patients and mini-thoracotomy in 35 patients. The ring was adjusted after declamping and weaning from cardio-pulmonary bypass under echocardiographic guidance if the coaptation surface was not optimal, or in cases of residual mitral regurgitation. Follow-up was performed up to 2 years post-procedure. Mean age was 61 ± 12 years. Ring adjustment was performed in 71% of patients to optimise the results of mitral valve repair. Following the procedure, 11/45 patients (24%) who had had mild residual mitral regurgitation had no mitral regurgitation following ring adjustment. Two patients with severe mitral regurgitation post-procedure had mild regurgitation following ring adjustment. Coaptation length increased significantly after adjustment. One patient died before hospital discharge due to complications unrelated to the adjustable ring. One patient had to undergo re-operation at 39 days post-procedure due to endocarditis. At 2 years of follow-up, 78% of patients had no residual mitral regurgitation and 22% had mild residual mitral regurgitation. Adjustable mitral annuloplasty ring implantation was safe in all patients. Mitral valve repair with the adjustable ring was durable in all patients who reached 2 years follow-up.
  
  
  BACKGROUND
  NCT01617720.
authors.affiliation: Department of Cardiothoracic and Vascular Surgery, Deutsches Herzzentrum Berlin, Augustenburger Platz 1, 13353, Berlin, Germany. suendermann@dhzb.de.|DZHK (German Centre for Cardiovascular Research), Partner Site Berlin, Berlin, Germany. suendermann@dhzb.de.
authors.forename: Simon H
authors.initials: SH
authors.lastname: Sündermann
authors.affiliation: Klinikum Passau, Department of Cardiac Surgery. Innstrasse 76, 94032, Passau, Germany.
authors.forename: Markus
authors.initials: M
authors.lastname: Czesla
authors.affiliation: Department of Cardiothoracic and Vascular Surgery, Deutsches Herzzentrum Berlin, Augustenburger Platz 1, 13353, Berlin, Germany.
authors.forename: Jörg
authors.initials: J
authors.lastname: Kempfert
authors.affiliation: Department of Cardiac Surgery, Kerckhoff-Klinik, Benekestr. 2-8, 61231, Bad Nauheim, Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Walther
authors.affiliation: Department of Cardiac Surgery, Assistance Publique-Hôpitaux de Paris, Bichat Hospital, Paris, France.
authors.forename: Patrick
authors.initials: P
authors.lastname: Nataf
authors.affiliation: Department of Cardiac Surgery, Sheba Medical Center, Tel-Hashomer, Israel.
authors.forename: Ehud
authors.initials: E
authors.lastname: Raanani
authors.affiliation: Department of Cardiothoracic and Vascular Surgery, Deutsches Herzzentrum Berlin, Augustenburger Platz 1, 13353, Berlin, Germany.|DZHK (German Centre for Cardiovascular Research), Partner Site Berlin, Berlin, Germany.
authors.forename: Stephan
authors.initials: S
authors.lastname: Jacobs
authors.affiliation: Department of Cardiovascular Surgery, San Raffaele Hospital, Milan, Italy.
authors.forename: Ottavio
authors.initials: O
authors.lastname: Alfieri
authors.affiliation: University Hospital of Zurich, Heart Center, Zurich, Switzerland.
authors.forename: Francesco
authors.initials: F
authors.lastname: Maisano
authors.affiliation: Department of Cardiothoracic and Vascular Surgery, Deutsches Herzzentrum Berlin, Augustenburger Platz 1, 13353, Berlin, Germany.|DZHK (German Centre for Cardiovascular Research), Partner Site Berlin, Berlin, Germany.|Charité, Universitätsmedizin Berlin, Berlin, Germany.
authors.forename: Volkmar
authors.initials: V
authors.lastname: Falk
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D004452:Echocardiography; D005060:Europe; D005260:Female; D005500:Follow-Up Studies; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation; D006801:Humans; D007557:Israel; D008297:Male; D008875:Middle Aged; D008943:Mitral Valve / Q000601:surgery*; D008944:Mitral Valve Insufficiency / Q000000981:diagnostic imaging* / Q000601:surgery*; D011446:Prospective Studies; D011474:Prosthesis Design; D012086:Reoperation / Q000706:statistics & numerical data; D016896:Treatment Outcome
keywords: Mitral regurgitation; Mitral valve annuloplasty