Thorac Cardiovasc Surg 2023; 71(S 01): S1-S72
DOI: 10.1055/s-0043-1761813
Tuesday, 14 February
AV Klappentherapie im Herzteam

Periprocedural Outcomes of Transcatheter Mitral Valve Implantation Using a Tethered Device in a Post-market Follow-up Study

Autoren

  • L. Conradi

    1   Universitäres Herz- und Gefäßzentrum Hamburg, Hamburg, Deutschland

  • A. S. Petronio

    2   Azienda Ospedaliero Universitaria Pisana, Pisa, Italy

  • H. Ruge

    3   Deutsches Herzzentrum München, Munich, Deutschland

  • L. Labrousse

    4   Hôpital Cardiologique de Haut Lévèque, Pessac, France

  • T. Walther

    5   Klinikum der Johann Wolfgang Goethe-Universität Frankfurt, Frankfurt, Deutschland

  • O. Reuthebuch

    6   Basel University Hospital, Basel, Switzerland

  • F. Praz

    7   Center Inselspital Bern, Bern, Switzerland

  • A. Zierer

    8   Kepler University Hospital, Med Campus IV., Linz, Austria

  • J. Kempfert

    9   Deutsches Herzzentrum Berlin, Berlin, Deutschland

  • P. Sardari Nia

    10   Maastricht University Medical Center+, Maastricht, The Netherlands

  • S. Bleiziffer

    11   Herz- und Diabeteszentrum NRW, Bad Oeynhausen, Bad Oeynhausen, Deutschland

  • G. Dahle

    12   Oslo University Hospital, Rikshospitalet, Oslo, Norway

  • G. Lutter

    13   Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel, Deutschland

  • N. Dumonteil

    14   Clinique Pasteur, Toulouse, France
Weitere Informationen
  Alle Artikel dieser Rubrik

Background: Transapical transcatheter mitral valve implantation (TMVI) provides treatment for severely ill patients with symptomatic mitral regurgitation (MR) deemed poor candidates for conventional surgery. A prospective, multi-center, single-arm, post-market follow-up (PMCF) study is enrolling to confirm safety and efficacy of a tethered transapical (TA) transcatheter heart valve (THV) in patients with severe symptomatic MR at high risk for surgery.

Method: Fifty patients were treated using this TA THV from May 2021 to January 2022 at 19 European centers and followed for 30 days. Baseline characteristics, periprocedural outcomes, serious adverse events and mortality are reported according to MVARC definition.

Results: Patients (age 74.3 ± 7.0 years, 32/50 [64.0%] male, 36/49 [73.5%] NYHA III/IV, LVEF 47.7 ± 13.1%) presented with a pronounced overall risk profile due to increased prevalence of coronary artery disease (31/50, 62.0%), pulmonary hypertension (28/50, 56.0%), renal failure (28/50, 56.0%) or additional valvular heart disease (38/50, 76.0%) resulting in Society of Thoracic Surgeons Predicted Risk of Mortality (STS-PROM) score of 10.0 ± 8.6%. Etiology of MR was primary (20/45, 44.4%), secondary (19/45, 42.2%), or mixed (6/45, 13.3%). Procedure and device times were 124.4 (range: 63–292) and 56.7 (range: 21–144) minutes, respectively. Valve implant rate was 96% (48/50) with two cases of THV retrieval due to concern of left ventricular outflow track obstruction (LVOTO). There was no conversion to surgery or procedural mortality. Technical success rate was 90.0% (45/50). Mean transmitral gradient was 4.1 ± 1.3 mm Hg at discharge, and 3.3 ± 1.6 mm Hg at 30-day. Paravalvular leakage was absent in all followed patients. All-cause and cardiovascular mortality and disabling stroke at 30 days were 8.0% (4/50), 4.0% (2/50) and 2.0% (1/50), respectively.

Conclusion: Preliminary experience in this PMCF study confirms an acceptable acute safety profile in high-risk patients. Excellent hemodynamic results with complete MR elimination in all patients treated with this TA THV were observed under real-world conditions. Results will have to be confirmed during further enrollment in this registry.



Publikationsverlauf

Artikel online veröffentlicht:
28. Januar 2023

© 2023. Thieme. All rights reserved.

Georg Thieme Verlag KG
Rüdigerstraße 14, 70469 Stuttgart, Germany