Zusammenfassung
Die funktionelle Mitralklappeninsuffizienz (FMR) ist charakterisiert durch eine unzureichende Adaptation des vorderen und hinteren Mitralklappensegels sekundär infolge einer Dilatation des Mitralklappenannulus und/oder einer schweren Zügelung („tethering“) der Segel aufgrund einer Dilatation des linken Ventrikels. Seit dem Jahr 2015 steht das Cardioband®-System als katheterinterventionelles direktes Annuloplastieverfahren zur Verfügung. Im Rahmen der CE-Zulassungsstudie wurden insgesamt 60 Patienten in der Per-Protokoll-Auswertung analysiert. Die technische Erfolgsrate der Prozedur, definiert als erfolgreiche Implantation und Raffung, lag bei 97 %; die Einjahresüberlebensrate betrug 87 % (66 % mit zusätzlicher Abwesenheit einer Rehospitalisierung wegen Herzinsuffizienzsymptomen). Derzeit sind verschiedene interventionelle Therapieverfahren wie die Edge-to-edge-Technik sowie die direkte und die indirekte Annuloplastie verfügbar. Zusammenfassend erscheinen insbesondere Patienten mit einer FMR infolge einer Dilatation des Mitralklappenrings gut geeignet für eine direkte Annuloplastie mit dem Cardioband®.
Abstract
Functional mitral regurgitation (FMR) is characterized by a dilatation of the mitral valve annulus resulting in an insufficient adaptation of the anterior and posterior mitral valve leaflets and/or severe tethering of the leaflets due to dilatation of the left ventricle. The Cardioband® system was introduced in 2015 and is a catheter-based direct mitral valve annuloplasty procedure for treatment of FMR. In the European CE approval study 60 patients with moderate or severe FMR were analyzed per protocol. There were no device or procedure-related deaths. The technical success rate of the procedure, defined as successful implantation and tightening was 97%. At 1 year, the overall survival and survival free of hospital readmission for heart failure were 87% and 66%, respectively. Currently, various interventional treatment procedures are available, such as the edge-to-edge technique as well as direct and indirect annuloplasty. In summary, patients with FMR as a result of a dilatation of the mitral valve annulus appear to be suitable for direct annuloplasty with the Cardioband® system.
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C. Frerker erhielt Vortragshonorare und Reisekostenerstattungen von Abbott Vascular und Edwards Lifesciences. T. Schmidt erhielt Vortragshonorare und Reisekostenerstattungen von Edwards Lifesciences R. Pfister erhielt Reisekostenerstattungen von Abbott Vascular und Edwards Lifesciences M. I. Körber, V. Mauri und M. Wösten geben an, dass keine Interessenkonflikte bestehen. S. Baldus erhielt Forschungsförderung von Abbott Vascular und Vortragshonorare von Abbott Vascular und Edwards Lifesciences.
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Frerker, C., Schmidt, T., Pfister, R. et al. Cardioband®: Wo stehen wir, was sind geeignete Patienten?. Herz 44, 596–601 (2019). https://doi.org/10.1007/s00059-019-4839-y
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DOI: https://doi.org/10.1007/s00059-019-4839-y