Publications

  • “Adjustable annuloplasty (enCorSQ) in the treatment of FMR”
    International Congress on Coronary Artery Disease (ICCAD): Florence, Italy; October 2013
    Read Presentation
  • “Adjustable mitral annuloplasty for the surgical treatment of ischaemic mitral insufficiency”
    Markus Czesla; Julia Gotte; Nicolas Doll
    Multimedia Manual of Cardio-Thoracic Surgery 2013 2013: mmt005-mmt005
    Full Text
  • “SCTS Annual Meeting and Cardiothoracic Forum 2013.”
    Dynamic mitral valve annuloplasty. A novel ring and the first UK experience; Movie Submission Adult Cardiac Clinical.
    N. Nikolaidis, C. Bannister, S. Livesey;
    Brighton Centre Southampton/UK March 17th – 19th 2013
  • “Dynamic Annuloplasty for Mitral Regurgitation”
    Langer, Borger, Czesla, Shannon, Sakwa, Doll, Cremer, Mohr, Schaefers; Department of Thoracic and Cardiovscular Surger, University Hospital Hamburg, Germany; Journal of Thoracic Cardiovascular Surgery, 2012 Feb 23
  • “Dynamic RING+STRING for ischemic mitral regurgitation: papillary muscle repositioning and modification for the septal-lateral diameter in the loaded beating heart under echocardiographic guidance”
    Langer, Groesdonk, Kunihara, Schaefers; Homburg, Germany; Journal of Thoracic and Cardiovascular Surgery; Vol 141, Number 5
  • “Mitralvitien-Update der Chirurgischen Therapie”
    Czesla M, et.al, Stuttgart, Germany; Aktuel kardiol 2012; 1: 144-148
  • “Successful Postoperative Activation of an Adjustable Annuloplasty Ring (MiCardia) in Recurrent Ischemic Mitral Valve Regurgitation” Czesla, Gotte, Voth, Roser, Weimar, Doll; Sana Herzchirurgie GmbH, Stuttgart, Germany Annals of Thoracic Surgery; August, 2012

Presentations

  • Safety and feasibility of a new adjustable mitral annuloplastyring: A multicenter European experience. EACTS 2014

    M. Andreas, N. Doll, S. Livesey, M. Castella, A. Kocher, F. Casselman, C. Bannister, D. Pereda, J.L. Pomar, G. Laufer, M. Czesla

    Objective: Recurrence of Mitral Regurgitation (MR) after mitral valve repair is not infrequent. We report the safety and feasibility of a novel adjustable annuloplasty device thatpermits downsizing the ring late after the initial surgery through a minimally invasive procedure under beating-heart conditions.

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    Methods: In this multicenter, non-randomized,observational registry, 82 patients with moderate or severe MR (mean age 69±10 years,mean EuroSCORE II 6.85±6.35, 70% male, 51% ischemic MR and 33% dilative cardiomyopathy) undergoing surgical mitral valve repair with this device were evaluated. Endpoints included: in-hospital mortality, MR reduction, and ring adjustment at follow-up.

    Results: In all patients, a significant reduction in MR was accomplished in the initial surgical procedure (99% of the patients with none or mild MR). In-hospital mortality was observed in 4 patients, 2 cardiac not device related, and 2 non-cardiac deaths. Ring dehiscence occurred in 1 patient, stroke in 2 patients.

    In 12 patients (15%), an attempt to adjust the ring was performed due to recurrent MR (mean 9.5 months after surgery; 1 week – 19 months). In 3 of these attempts a technical failure occurred, in one patient, MR was reduced 2 levels, in 2 patients MR was reduced 1 level, and in 6 patients, MR did not change significantly.

    Conclusions: We conclude that implantation of this new adjustable annuloplasty ringis safe and effective. Late adjustment of this ring is feasible and may allow addressing recurrent MR. Additional experience and long-term follow-up are required to establish the clinical value of this technology.

  • “Minimally Invasive Late Activation of an Adjustable Mitral Ring: Developing a Clinical Pathway towards a New Treatment Concept”
    M.Andreas, M.Uy, T. Binder, C. Rath, A. Habertheuer, D. Wiedemann, G. Laufer, A. Kocher
    ISMICS 2014
    Objective: Mitral valve repair became the first-line therapy in patients suffering from mitral valve regurgitation (MR). A clinically relevant number of patients return due to ischemic heart disease are at increased risk for recurrent MR. We investigated a novel mitral ring which allows for a redction of the anterior-posterior diameter through remote adjustment at any time point after surgery. Herein we present out clinical experience and considerations for device handling and patient selection.

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    Methods: Twenty-eight patients (71+/- 9 years; 19m/9f) received the adjustable ring between 2011 and 2013. The mean logistic EuroScore was 17 +/- 13. All but two patients underwent concomitant procedures. The activation lead of the mitral ring was run through a small puncture in the left atrial wall and placed subcutaneously above the rectus sheath. The lead was located by fluoroscopy when activation was indicated. An electrical impulse was applied for 45 seconds to activate the ring, which resulted in adjusted ring shape with a decreased anterior-posterior diameter.

    Results: Ring implantation was safe and did not result in prolonged aortic cross clamp times. Tewnty-six patients are alive with a mean follow-up of 13 months. Two patients were successfully adjusted applying a minimally invasive approach. Both had a recurrent MR > 2. Following adjustment, MR was reduced to grade 1 in the first patient. Activation in the second patient did not results in a significant change in MR grade, but both patients improved clinically. In one patient with ischemic MR, the ring, which was deliberately downsized at implantation, became partially dehiscent without activation and the valve had to be replaced. On ring could not be adjusted due to technical problems.

    Conclusions: Implantation of this adjustable mitral ring is safe and feasible. The adjustment can be performed by a minimally invasive approach. The clinical benefit of this device remains to be revealed. We changed our implantation strategy to use this device in ischemic MR and annular dilatation, because these patients are at a higher risk for recurrent MR. Our experience with the new device led to the development of a whitepaper regarding optimal lead placement. Furthermore, an expert statement on the optimal time point of activation was developed (recurrent MR2+).

  • First experiences with adjustable annuloplasty in degenerative MR patients Markus Czesla. ISMICS: Prague 06/2013
    Sana Herzchirurgie Stuttgart, Stuttgart, Germany.

    Objective: The use of an adjustable, semi-rigid annuloplasty ring in patients with degenerative MR allows post pump adjustment for optimal results in valve repair.

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    Methods: Participating in a post market study to evaluate to clinical outcome using this novel device currently 20 patients have been enrolled at our institution. All patients were scheduled for mitral valve repair and experienced post-pump ring adjustment for optimization of coaptation under real time echocardiography guidance.

    Results: All patients presented with anterior, posterior, bileaflet prolaps or even barlow disease were treated with implantation of neochordae following annuloplasty. Postoperative off pump adjustment by a mechanical rotating cable attached to the ring leads to an increase in coaptation length up to 4 mm and a disappearance of residual MR.

    Conclusions: Postoperative results in all patients were satisfying without any residual MR. The repair of anterior or bileaflet prolapse proves sometimes to be difficult in terms of the correct length of the neocardae. Using postoperative adjustment of the ring diameter may compensate any inaccuracy and prevent SAM phenomenon.

    In our experiences the adjustable annuloplasty device may have the potential for regular use in patients with degenerative mitral valve disease.

  • Abstract #1456: Dallas-Leipzig Meeting, 12/2012 Single Center Experience with a Novel Dynamic Mitral RingBackground: Significant regurgitation returns within 6-12 months after surgery in a considerable number of patients with mitral valve repair.

    Purpose: In this current single center study we investigated a novel dynamic mitral ring, MiCardia enCorSQ, which allows the reduction of the anterior-posterior diameter of the mitral ring at any time point after surgery.

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    Methods: Nineteen patients (67+/-9 years; 14m/5f) were enrolled in the study. The mean logistic EuroScore was 14. All but two patients underwent concomitant procedures. The activation lead of the mitral ring was run through a small puncture in the left atrial wall and placed subcutaneously above the rectus sheath. Ten patients had a functional regurgitation and nine patients presented with degenerative mitral regurgitation.

    Findings: Seventeen patients are alive with a mean follow-up of 10 months. Aortic cross clamp times were not prolonged by the procedure. One patient was successfully activated 13 months post implantation. He had a recurrent mitral regurgitation grade II-III, deterioration of cardiac function and increasing ventricular dimensions. Upon activation, regurgitation was reduced to grade I. In a patient with ischemic MR, the ring, which was deliberately downsized, became partially dehiscent.

    Conclusion: Implantation of the innovative dynamic annulaplasty ring is safe and feasible. The clinical benefit of this device is promising and further ongoing clinical trials will quantify the benefit of late adjustment.

    Location of Primary Work: Not Applicable

    Presentation Language: English

    Total Words: 213

    Author 1: Alfred Kocher
    Organization 1: Medical University of Vienna

    Author 2: Dominik Wiedemann
    Organization 2: Medical University of Vienna

    Author 3: Michelle Uy
    Organization 3: Medical University of Vienna

    Author 4: Thomas Binder
    Organization 4: Medical University of Vienna

    Author 5: Guenther Laufer
    Organization 5: Medical University of Vienna

    Author 6: Martin Andreas
    Organization 6: Medical University of Vienna

    Presentation Format: Panel
    Language: English
    Presenter: Martin Andreas

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