TY - JOUR
T1 - Leaflet edge-to-edge treatment versus direct annuloplasty in patients with functional mitral regurgitation
AU - Weber, Marcel
AU - Öztürk, Can
AU - Taramasso, Maurizio
AU - Pozzoli, Alberto
AU - Pfister, Roman
AU - Wösten, Monique
AU - Alessandrini, Hannes
AU - Latib, Azeem
AU - Denti, Paolo
AU - Kuck, Karl Heinz
AU - Maisano, Francesco
AU - Baldus, Stephan
AU - Nickenig, Georg
N1 - Funding Information:
M. Weber has received travel grants from Edwards Lifesciences and honoraria for advisory boards from Abbott. M. Taramasso is a consultant for Abbott Vascular and has received speaker honoraria from Edwards Lifesciences. R. Pfister has received a travel grant from Abbott. H. Alessandrini has received travel grants from Abbott Vascular and Edwards Lifesciences and honoraria for advisory boards from Edwards Lifesciences. A. Latib has served on advisory boards for Abbott and has been a consultant to Edwards Lifesciences and Abbott and receives research grants from Abbott Vascular and Edwards Lifesciences. P. Denti is a consultant for Abbott Vascular, has received speaker honoraria from Edwards Lifesciences and has been a consultant for Valtech. K.H. Kuck has been a consultant for Abbott and Edwards Lifesciences, has an economic relationship with Valtech and has received research grants from Abbott Vascular and Edwards Lifesciences. F. Maisano has been a consultant for and received institutional grants from Valtech and Edwards Lifesciences, is a shareholder of Valtech Cardio and receives royalties from Edwards Lifesciences. S. Baldus has received speaker’s honoraria as well as travel and grant support from Edwards Lifesciences. G. Nickenig has received research funding, participated in clinical trials and received honoraria for lectures or advisory boards from Abbott and Edwards Lifesciences. The other authors have no conflicts of interest to declare.
Publisher Copyright:
© 2019 Pensoft Publishers. All rights reserved.
PY - 2019/11
Y1 - 2019/11
N2 - Aims: Interventional mitral repair techniques have evolved as safe and effective treatment options for patients with functional mitral regurgitation (FMR) at high or prohibitive surgical risk. Of the techniques available, the MitraClip device and Cardioband mitral repair system have been used most commonly. However, a direct comparison of the two devices, examining their effectiveness at reducing MR, reducing symptoms, and extending life expectancy, has not yet been performed. For this purpose, we compared the outcome of patients after direct annuloplasty by the Cardioband system with patients after edge-to-edge therapy with the MitraClip device in a propensity score-matched analysis. Methods and results: We collected data concerning 123 consecutive patients who were treated with the Cardioband device and 455 consecutive patients treated with the MitraClip from five experienced European centres. Propensity score matching was performed, resulting in two groups with 93 patients each - with no significant differences regarding baseline demographic parameters - who underwent standardised 2D transthoracic echocardiography with assessment at baseline and clinical follow-up at 12 months. The success rate, defined as a reduction of MR to grade 2 or lower, was high in both groups (MR ≥2: MitraClip: 86%, Cardioband: 77%, p=0.18). The Cardioband was better at reducing heart failure symptoms (NYHA ≥II: 88%) than the MitraClip (75%) procedure (p=0.046) at 12-month follow-up. All-cause rehospitalisation and mortality within 12 months were lower in Cardioband patients (mortality: OR 0.30, CI: 0.09-0.98, p=0.032; rehospitalisation: OR 0.57, CI: 0.28-0.97, p=0.03). Conclusions: The MitraClip and the Cardioband procedures effectively reduce MR and heart failure symptoms. However, patients undergoing the Cardioband procedure showed a more pronounced improvement with regard to functional NYHA class, rehospitalisation, and mortality, compared to patients undergoing the MitraClip procedure.
AB - Aims: Interventional mitral repair techniques have evolved as safe and effective treatment options for patients with functional mitral regurgitation (FMR) at high or prohibitive surgical risk. Of the techniques available, the MitraClip device and Cardioband mitral repair system have been used most commonly. However, a direct comparison of the two devices, examining their effectiveness at reducing MR, reducing symptoms, and extending life expectancy, has not yet been performed. For this purpose, we compared the outcome of patients after direct annuloplasty by the Cardioband system with patients after edge-to-edge therapy with the MitraClip device in a propensity score-matched analysis. Methods and results: We collected data concerning 123 consecutive patients who were treated with the Cardioband device and 455 consecutive patients treated with the MitraClip from five experienced European centres. Propensity score matching was performed, resulting in two groups with 93 patients each - with no significant differences regarding baseline demographic parameters - who underwent standardised 2D transthoracic echocardiography with assessment at baseline and clinical follow-up at 12 months. The success rate, defined as a reduction of MR to grade 2 or lower, was high in both groups (MR ≥2: MitraClip: 86%, Cardioband: 77%, p=0.18). The Cardioband was better at reducing heart failure symptoms (NYHA ≥II: 88%) than the MitraClip (75%) procedure (p=0.046) at 12-month follow-up. All-cause rehospitalisation and mortality within 12 months were lower in Cardioband patients (mortality: OR 0.30, CI: 0.09-0.98, p=0.032; rehospitalisation: OR 0.57, CI: 0.28-0.97, p=0.03). Conclusions: The MitraClip and the Cardioband procedures effectively reduce MR and heart failure symptoms. However, patients undergoing the Cardioband procedure showed a more pronounced improvement with regard to functional NYHA class, rehospitalisation, and mortality, compared to patients undergoing the MitraClip procedure.
KW - Depressed left ventricular function
KW - Mitral regurgitation
KW - Mitral valve repair
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U2 - 10.4244/EIJ-D-19-00468
DO - 10.4244/EIJ-D-19-00468
M3 - Article
AN - SCOPUS:85070056379
SN - 1774-024X
VL - 15
SP - 912
EP - 918
JO - EuroIntervention
JF - EuroIntervention
IS - 10
ER -
