Key result
Third-generation MitraClip TEER achieves sustained secondary MR reduction to ≤1+ in ~93% at one year.
Why the study?
Real-world outcomes with third-generation MitraClip systems for secondary mitral regurgitation in heart failure patients were not well characterized.
Does transcatheter edge-to-edge repair with third-generation MitraClip systems improve MR and clinical outcomes in symptomatic patients with severe secondary mitral regurgitation?
Observational (n=413)
Yes
Does transcatheter edge-to-edge repair with third-generation MitraClip systems improve MR and clinical outcomes in symptomatic patients with severe secondary mitral regurgitation?
Third-generation MitraClip devices provide sustained MR reduction and symptomatic improvement in patients with severe secondary mitral regurgitation in a real-world setting.
Sustained MR reduction with third-generation MitraClip links to fewer deaths or HFH in secondary MR; hypothesis-generating and requires randomized confirmation.
AIMS: Mitral valve transcatheter edge-to-edge repair is a guideline-recommended treatment option for patients with secondary mitral regurgitation (SMR). The purpose of this analysis was to report contemporary real-world outcomes in SMR patients treated with third-generation MitraClip systems. METHODS AND RESULTS: EXPAND is a prospective, multicentre, international, single-arm study with 1041 patients treated for mitral regurgitation (MR) with MitraClip NTR/XTR, with 30-day and 1-year follow-up. All echocardiograms were analysed by an independent echocardiographic core lab. Study outcomes included procedural outcomes, durability of MR reduction, and major adverse events including all-cause mortality and heart failure hospitalizations (HFH). A subgroup of 413 symptomatic patients (age 74.7 ± 10.1 years, 58% male) with severe SMR were included. MR reduction to MR ≤ 1+ and MR ≤ 2+ was achieved in 93.0% and 98.5% of patients, respectively, which was sustained at 1-year follow-up. All-cause mortality was 17.7% at 1-year- follow-up, and the combined endpoint of all-cause mortality or first HFH occurred in 34% of patients. This combined endpoint was significantly less frequently observed in MR ≤ 1+ patients (Kaplan-Maier estimates: 29.7% vs. 69.6% for MR ≤ 1+ vs. MR ≥ 2 +; p < 0.0001). New York Heart Association (NYHA) functional class improved significantly from baseline (NYHA ≤ II: 17%) to 1-year follow-up (NYHA ≤ II: 78%) (p < 0.0001). While MR reduction was comparable between NTR-only vs. XTR-only treated patients, less XTR clips were required for achieving MR reduction. CONCLUSIONS: Under real-world conditions, optimal sustained MR reduction to MR ≤ 1+ was achieved in a high percentage of patients with third-generation MitraClip, which translated into symptomatic improvement and low event rates. These results appear to be comparable with recent randomized clinical trials.
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Orban et al. (2023) conducted an observational in Severe secondary mitral regurgitation in heart failure (n=413). MitraClip NTR/XTR was evaluated on MR reduction to MR ≤ 1+. Transcatheter edge-to-edge repair with third-generation MitraClip achieved sustained MR reduction to ≤1+ in 93.0% of patients with severe secondary mitral regurgitation at 1 year.