Contemporary Outcomes Following Transcatheter Edge-to-Edge Repair: 1-Year Results From the EXPAND Study.

BACKGROUND

The third-generation MitraClip NTR/XTR transcatheter edge-to-edge repair system was introduced to assist in leaflet grasping with the longer clip arms of MitraClip XTR and to improve ease of use with the modified delivery catheter.

OBJECTIVES

The EXPAND study evaluated contemporary real-world outcomes in subjects with mitral regurgitation (MR) treated with the third-generation MitraClip NTR/XTR transcatheter edge-to-edge repair system.

METHODS

EXPAND is a prospective, multicenter, international, single-arm study that enrolled patients with primary MR and secondary MR at 57 centers. Follow-up was conducted through 12 months. Echocardiograms were analyzed by an echocardiographic core laboratories. Study outcomes included: MR severity, functional capacity measured by New York Heart Association functional class, quality of life measured by Kansas City Cardiomyopathy Questionnaire, heart failure hospitalizations, all-cause mortality.

RESULTS

1,041 patients were enrolled from April 2018 through March 2019, of which 50.5% had primary or mixed etiology. Implant success was 98.9%; 1.5 ± 0.6 clips were implanted per subject. Significant MR reduction from baseline (≥MR 3+: 56.0%) to 30 days (≤MR 1+:88.8%) was maintained through 1 year (MR ≤1+: 89.2%). A total of 84.5% and 93.0% of subjects in primary MR and secondary MR, respectively, had ≤1+ MR at 1 year. Significant improvements were observed in clinical outcomes (New York Heart Association functional class I/II in 80.3%, +21.6 improvement in Kansas City Cardiomyopathy Questionnaire score) at 1 year. All-cause mortality and heart failure hospitalizations at 1 year were 14.9% and 18.9%, respectively, which was significantly lower than previous studies.

CONCLUSIONS

The study demonstrates treatment with the third-generation system resulted in substantial reduction of MR in a contemporary real-world practice, compared with the results of earlier EVEREST and COAPT trials.(The MitraClip® EXPAND Study of the Next Generation of MitraClip® Devices [EXPAND]; NCT03502811).

Informations de copyright

Copyright © 2023. Published by Elsevier Inc.

Déclaration de conflit d'intérêts

Funding Support and Author Disclosures The EXPAND study was funded and sponsored by Abbott. Dr Kar has received grants and institutional research support from Abbott, Boston Scientific, and Edwards Lifesciences; has received consulting fees/honoraria from Abbott, Boston Scientific, W.L. Gore, and Medtronic; served as a steering committee member of the TRILUMINATE study (Abbott); and served as national principal investigator of the EXPAND study and the REPAIR MR study for Abbott. Dr von Bardeleben has served in unpaid trial activities for Abbott, Edwards Lifesciences, and University of Göttingen (IIT); and has served on an advisory or Speakers Bureau for Abbott Cardiovascular, Bioventrix, Boston Scientific, Cardiac Dimensions, Edwards Lifesciences, and Neochord. Prof Rottbauer has received consulting fees/speaker honoraria from Abbott, Bayer Healthcare, Boston Scientific, Daiichi Sankyo, Edwards Lifesciences, and Medtronic; and is a member of the steering committee of the EXPAND G4 study for Abbott and Encourage AF study for Daiichi Sankyo. Dr Mahoney has served as proctor for Medtronic, Edwards Lifesciences, and Boston Scientific; has been a consultant for Abbott, Medtronic, Edwards Lifesciences, and Boston Scientific; and has received research support from Edwards Lifesciences, Medtronic, Abbott, and Boston Scientific. Dr Price has received consulting fees from AstraZeneca, Chiesi USA, Medtronic, Boston Scientific, Abbott, and WL Gore outside of the submitted work. Dr Grasso has served as a proctor for Abbott and Boston Scientific; and has received speaker fees from Edwards Lifesciences. Dr Williams has received research funding from Abbott, Medtronic, BSC, and Edwards Lifesciences. Prof Lurz has served as a consultant and received institutional fees and research grants from Abbott, Edwards Lifesciences, Medtronic, ReCor, and Occlutech. Dr Ahmed has served as a proctor and advisor, and received consulting fees and research grants from Abbott, Edwards Lifesciences, and Medtronic. Prof Hausleiter has received research support from Abbott Vascular and Edwards Lifesciences. Dr Chehab has received study grants and consulting fees from Abbott, Edwards Lifesciences, and Biotronics. Dr Zamorano has received speaker honoraria from Pfizer, Amgen, and Daiichi Sankyo; and research grants from Abbott and Edwards Lifesciences. Dr Asch’s work as director of an academic core laboratory is paid by institutional research grants (MedStar Health) from Abbott, Boston Scientific, Medtronic, Edwards Lifesciences, Neovasc, Ancora Heart, Livanova, MVRx, InnovHeart, Polares Medical, and Aria CV. Prof Maisano has received grant and/or institutional research support from Abbott, Medtronic, Edwards Lifesciences, Biotronik, Boston Scientific Corporation, NVT, and Terumo; and has received consulting fees, personal and institutional honoraria from Abbott, Medtronic, Edwards Lifesciences, Xeltis, and Cardiovalve; has received royalty income/IP rights from Edwards Lifesciences; and is a shareholder (including share options) of Cardiogard, Magenta, SwissVortex, Transseptalsolutions, Occlufit, 4Tech, and Perifect.