Clinical Outcomes With Transcatheter Edge-to-Edge Repair in Atrial Functional MR From the EXPAND Study

Nishtha Sodhi; Federico M Asch; Tobias Ruf; Aniela Petrescu; Ralph Stephan von Bardeleben; D Scott Lim; Francesco Maisano; Saibal Kar; Matthew J Price

doi:10.1016/j.jcin.2022.07.023

Clinical Outcomes With Transcatheter Edge-to-Edge Repair in Atrial Functional MR From the EXPAND Study

JACC Cardiovasc Interv. 2022 Sep 12;15(17):1723-1730. doi: 10.1016/j.jcin.2022.07.023.

Authors

Nishtha Sodhi¹, Federico M Asch², Tobias Ruf³, Aniela Petrescu³, Ralph Stephan von Bardeleben³, D Scott Lim⁴, Francesco Maisano⁵, Saibal Kar⁶, Matthew J Price⁷

Affiliations

¹ Department of Cardiology, University of Virginia Medical Center, Charlottesville, Virginia, USA. Electronic address: nishthasodhi@gmail.com.
² Cardiovascular Core Laboratories, MedStar Health Research Institute, Washington, District of Columbia, USA.
³ University Medical Center of Mainz, Mainz, Germany.
⁴ Department of Cardiology, University of Virginia Medical Center, Charlottesville, Virginia, USA.
⁵ San Raffaele University Hospital, Milan, Italy.
⁶ Los Robles Regional Medical Center, Thousand Oaks, California, USA.
⁷ Division of Cardiovascular Diseases, Scripps Clinic, La Jolla, California, USA.

PMID: 36075643
DOI: 10.1016/j.jcin.2022.07.023

Abstract

Background: Although transcatheter edge-to-edge repair (TEER) has been shown to improve clinical outcomes and improve quality of life in patients with symptomatic secondary mitral regurgitation (SMR) and left ventricular dysfunction, its effect in patients with atrial SMR (aSMR) has not been well described.

Objectives: The aim of this study was to assess the safety, echocardiographic outcomes, and clinical effectiveness of TEER for aSMR.

Methods: Patients with aSMR in the prospective, observational, multicenter EXPAND (A Contemporary, Prospective, Multi-Center Study Evaluating Real-World Experience of Performance and Safety for the Next Generation of MitraClip Devices) study were identified by an echocardiography core laboratory. Follow-up occurred at discharge, 30 days, and 1 year. Key endpoints included mitral regurgitation (MR) severity, functional class, heart failure hospitalizations, mortality, and 30-day major adverse events.

Results: Among 1,041 patients enrolled in EXPAND, 835 patients had evaluable echocardiograms at baseline. Of these, 53 patients had aSMR and 360 had ventricular SMR (vSMR). In the aSMR cohort, TEER resulted in a significant reduction in MR through 1 year (MR grade ≤2 in 100.0%), significantly increased 1-year Kansas City Cardiomyopathy Questionnaire score (+26.6 ± 30.5 points; P < 0.0001), and improved functional class from baseline, similar to the effects among patients with vSMR (MR grade ≤2 in 99.5% at 1 year, 1-year increase in Kansas City Cardiomyopathy Questionnaire score 21.23 ± 24.92 points). Major adverse events at 30 days and leaflet adverse events at 1 year were infrequent in both groups.

Conclusions: In a prospective, real-world, global registry, TEER for aSMR was associated with significant MR reduction and improvement in quality of life and functional class, similar to patients with vSMR. This suggests that TEER may provide clinical benefit in patients with atrial fibrillation with SMR in the setting of heart failure with preserved ejection fraction. (The MitraClip® EXPAND Study of the Next Generation of MitraClip® Devices; NCT03502811).

Keywords: atrial secondary MR; mitral regurgitation; mitral valve repair.

Publication types

Multicenter Study
Research Support, Non-U.S. Gov't

MeSH terms

Cardiac Catheterization
Cardiomyopathies* / complications
Heart Failure* / complications
Heart Failure* / diagnostic imaging
Heart Failure* / therapy
Heart Valve Prosthesis Implantation*
Humans
Mitral Valve Insufficiency* / complications
Mitral Valve Insufficiency* / diagnostic imaging
Mitral Valve Insufficiency* / surgery
Prospective Studies
Quality of Life
Treatment Outcome

Associated data

ClinicalTrials.gov/NCT03502811