New Research Paper
Structural
Contemporary Outcomes Following Transcatheter Edge-to-Edge Repair: 1-Year Results From the EXPAND Study

https://doi.org/10.1016/j.jcin.2023.01.010Get rights and content
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Abstract

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)

Key Words

MitraClip
mitral regurgitation
mitral valve repair
transcatheter edge-to-edge repair (TEER)

Abbreviations and Acronyms

ASE
American Society of Echocardiography
ECL
echocardiographic core laboratory
HFH
heart failure hospitalizations
KCCQ
Kansas City Cardiomyopathy Questionnaire
LV
left ventricle/ventricular
MI
myocardial infarction
MR
mitral regurgitation
MV
mitral valve
NYHA
New York Heart Association
PMR
primary (degenerative) mitral regurgitation
QoL
quality of life
SLDA
single leaflet device attachment
SMR
secondary (functional) mitral regurgitation
TEE
transesophageal echocardiography
TEER
transcatheter edge-to-edge repair
TTE
transthoracic echocardiography

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