Transcatheter edge‐to‐edge repair for secondary mitral regurgitation with third‐generation devices in heart failure patients – results from the Global EXPAND Post‐Market study

• Published in: European journal of heart failure Vol. 25; no. 3; pp. 411 - 421
• Main Authors: Orban, Mathias, Rottbauer, Wolfgang, Williams, Mathew, Mahoney, Paul, von Bardeleben, Ralph Stephan, Price, Matthew J., Grasso, Carmelo, Lurz, Philipp, Zamorano, Jose L., Asch, Federico M., Maisano, Francesco, Kar, Saibal, Hausleiter, Jörg
• Format: Journal Article
• Language: English
• Published: Oxford, UK John Wiley & Sons, Ltd 01.03.2023
• Subjects: Aged; Aged, 80 and over; Cardiac Catheterization; Female; Heart Failure; Heart Valve Prosthesis Implantation - methods; Humans; Male; Middle Aged; MitraClip; Mitral regurgitation; Mitral Valve - diagnostic imaging; Mitral Valve - surgery; Mitral Valve Insufficiency - surgery; Mitral valve transcatheter edge‐to‐edge repair; Prospective Studies; Secondary mitral regurgitation; Transcatheter mitral valve repair; Treatment Outcome; Heart failure; Mitral regurgitation; Transcatheter mitral valve repair; MitraClip; Mitral valve transcatheter edge-to-edge repair; Secondary mitral regurgitation
• ISSN: 1388-9842; 1879-0844; 1879-0844
• DOI: 10.1002/ejhf.2770

ABSTRACT 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. (A) Subject consort diagram. (B) Illustrations showing MitraClip NTR, which is identical to the original MitraClip NT/classic clip, and MitraClip XTR, which has longer clip arms for easier grasp and better reach. (C) Number of devices implanted with NTR only and XTR only showing more single clip use when XTR is used. (D) Combined all‐cause mortality and heart failure (HF) hospitalization through 1‐year follow‐up for the EXPAND SMR population as stratified by discharge residual mitral regurgitation (MR) >1+ and ≤1+ as assessed by echocardiography core lab; event rates are Kaplan–Meier time to first event estimates. PMR, primary mitral regurgitation; SMR, secondary mitral regurgitation.