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

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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.

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Acknowledgement

We thank Anne Gale of the Deutsches Herzzentrum Berlin for editorial assistance. This work was supported by Valtech Cardio Ltd.

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Authors and Affiliations

  1. Department of Cardiothoracic and Vascular Surgery, Deutsches Herzzentrum Berlin, Augustenburger Platz 1, 13353, Berlin, Germany

    Simon H. Sündermann, Jörg Kempfert, Stephan Jacobs & Volkmar Falk

  2. DZHK (German Centre for Cardiovascular Research), Partner Site Berlin, Berlin, Germany

    Simon H. Sündermann, Stephan Jacobs & Volkmar Falk

  3. Klinikum Passau, Department of Cardiac Surgery. Innstrasse 76, 94032, Passau, Germany

    Markus Czesla

  4. Department of Cardiac Surgery, Kerckhoff-Klinik, Benekestr. 2-8, 61231, Bad Nauheim, Germany

    Thomas Walther

  5. Department of Cardiac Surgery, Assistance Publique-Hôpitaux de Paris, Bichat Hospital, Paris, France

    Patrick Nataf

  6. Department of Cardiac Surgery, Sheba Medical Center, Tel-Hashomer, Israel

    Ehud Raanani

  7. Department of Cardiovascular Surgery, San Raffaele Hospital, Milan, Italy

    Ottavio Alfieri

  8. University Hospital of Zurich, Heart Center, Zurich, Switzerland

    Francesco Maisano

  9. Charité, Universitätsmedizin Berlin, Berlin, Germany

    Volkmar Falk

Authors
  1. Simon H. Sündermann
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  2. Markus Czesla
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  3. Jörg Kempfert
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  4. Thomas Walther
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  5. Patrick Nataf
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  6. Ehud Raanani
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  7. Stephan Jacobs
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  8. Ottavio Alfieri
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  9. Francesco Maisano
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  10. Volkmar Falk
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Corresponding author

Correspondence to Simon H. Sündermann.

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Conflict of interest

O.A. is a minor stock holder of Valtech Cardio, F.M. is stock holder and consultant for Valtech cardio, V.F. is a consultant for Valtech Cardio, all other authors declare no conflict of interest.

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Supplementary material 1 Video 1: Video animation of the device and the procedure. (MPG 29104 kb)

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Sündermann, S.H., Czesla, M., Kempfert, J. et al. Results of mitral valve repair with an adjustable annuloplasty ring 2 years after implantation. Heart Vessels 32, 843–849 (2017). https://doi.org/10.1007/s00380-016-0934-7

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  • DOI: https://doi.org/10.1007/s00380-016-0934-7

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