Leaflet edge-to-edge treatment versus direct annuloplasty in patients with functional mitral regurgitation.

Abstract

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. 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). 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.