Aims: Mitral valve transcatheter edge-to-edge repair (M-TEER) is a guideline-recommended treatment option for patients with secondary mitral regurgitation (SMR). The purpose of this analysis is to report contemporary real-world outcomes in SMR patients treated with 3rd generation MitraClip systems. Methods and results: EXPAND is a prospective, multi-center, international, single arm study with 1041 patients treated for MR with MitraClip NTR/XTR, with 30-day and 1-year follow-up (FU). All echocardiograms were analyzed by an independent echocardiographic core lab. Study outcomes included: procedural outcomes, durability of MR reduction, and major adverse events including all-cause mortality and hospitalizations for heart failure (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-FU. All-cause mortality was 17.7% at 1-year-FU, and the combined endpoint of all-cause mortality or 1st HFH occurred in 34% of patients. This combined endpoint was significantly less frequently observed in MR≤1+ patients (Kaplan-Maier-estimates: 29.7% vs. 69.9% for MR≤1+ vs. MR≤2+; p<0.0001). NYHA functional class improved significantly from baseline (NYHA≤II:17%) to 1-year-FU (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 3rd generation MitraClip, which translated into symptomatic improvement and low event rates. These results appear to be comparable with recent randomized clinical trials. This article is protected by copyright. All rights reserved.
Transcatheter Edge-to-Edge Repair for Secondary Mitral Regurgitation with 3rd Generation Devices in Heart Failure Patients-Results from the Global EXPAND Post-Market Study
Maisano, Francesco;
2023-01-01
Abstract
Aims: Mitral valve transcatheter edge-to-edge repair (M-TEER) is a guideline-recommended treatment option for patients with secondary mitral regurgitation (SMR). The purpose of this analysis is to report contemporary real-world outcomes in SMR patients treated with 3rd generation MitraClip systems. Methods and results: EXPAND is a prospective, multi-center, international, single arm study with 1041 patients treated for MR with MitraClip NTR/XTR, with 30-day and 1-year follow-up (FU). All echocardiograms were analyzed by an independent echocardiographic core lab. Study outcomes included: procedural outcomes, durability of MR reduction, and major adverse events including all-cause mortality and hospitalizations for heart failure (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-FU. All-cause mortality was 17.7% at 1-year-FU, and the combined endpoint of all-cause mortality or 1st HFH occurred in 34% of patients. This combined endpoint was significantly less frequently observed in MR≤1+ patients (Kaplan-Maier-estimates: 29.7% vs. 69.9% for MR≤1+ vs. MR≤2+; p<0.0001). NYHA functional class improved significantly from baseline (NYHA≤II:17%) to 1-year-FU (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 3rd generation MitraClip, which translated into symptomatic improvement and low event rates. These results appear to be comparable with recent randomized clinical trials. This article is protected by copyright. All rights reserved.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
