Results of mitral valve repair with an adjustable annuloplasty ring 2 years after implantation

Simon H. Sündermann*, Markus Czesla, Jörg Kempfert, Thomas Walther, Patrick Nataf, Ehud Raanani, Stephan Jacobs, Ottavio Alfieri, Francesco Maisano, Volkmar Falk

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

4 Scopus citations

Abstract

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. Clinical Trial Registration: NCT01617720.

Original languageEnglish
Pages (from-to)843-849
Number of pages7
JournalHeart and Vessels
Volume32
Issue number7
DOIs
StatePublished - 1 Jul 2017
Externally publishedYes

Funding

FundersFunder number
Valtech Cardio Ltd
Horizon 2020 Framework Programme689617

    Keywords

    • Mitral regurgitation
    • Mitral valve annuloplasty

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