Dr. Ravza Betül Akbaş

RESHAPE-HF2: Percutaneous repair of moderate-to-severe or severe functional mitral regurgitation in patients with symptomatic heart failure

Published in Congress: ESC 2024

Link: Full text
https://www.nejm.org/doi/full/10.1056/NEJMoa2314328

Background:

The clinical outcomes of transcatheter mitral valve repair in patients with heart failure and functional mitral regurgitation remain uncertain due to varying results reported in previous studies.

Objective:

The RESHAPE-HF2 trial assessed the safety and efficacy of transcatheter mitral valve repair in patients with symptomatic heart failure and functional mitral regurgitation.

Methods:

The study included patients with moderate to severe mitral regurgitation and heart failure from nine countries and thirty centers. The patients were randomized into two groups: the first group, referred to as the device group, underwent transcatheter mitral valve repair along with guideline-directed medical therapy; the second group, known as the control group, received only medical therapy. Participants included those with NYHA class 2 or higher heart failure despite optimal medical treatment, who were not suitable for surgery, had a left ventricular ejection fraction between 20% and 50%, and had mitral regurgitation graded as 3+ or 4+. Patients with hospitalization due to heart failure or elevated plasma natriuretic peptide levels were also included. Exclusion criteria comprised individuals with degenerative mitral valve disease and those with a history of percutaneous coronary intervention, cardiovascular surgery, or atrial fibrillation ablation within the previous 90 days.

The primary outcomes of the study were defined as: the rate of first or recurrent hospitalizations due to heart failure or cardiovascular death over 24 months, the rate of first or recurrent hospitalizations due to heart failure over 24 months, and the change in the Kansas City Cardiomyopathy Questionnaire score (KCCQ-QS; scores range from 0 to 100, with higher scores indicating better health status) from baseline to 12 months.

Results:

In the RESHAPE-HF2 study, 250 patients were included in the device group, and 255 patients were included in the control group. The rate of first or recurrent hospitalizations due to heart failure or cardiovascular death over 24 months was 37% in the device group, compared to 58.9% in the control group (p=0.002). The rate of first or recurrent hospitalizations due to heart failure was 26.9% in the device group, compared to 46.6% in the control group (p=0.002). The KCCQ-QS score increased by 21.6±26.9 points in the device group, whereas it increased by 8.0±24.5 points in the control group (p<0.001). Device-related events occurred in 4 patients (1.6%).

Conclusion:

In heart failure patients with moderate to severe functional mitral regurgitation who are receiving medical therapy, the addition of transcatheter mitral valve repair has been shown to reduce the rates of first or recurrent hospitalizations due to heart failure or cardiovascular death, as well as hospitalizations due to heart failure, over a 24-month period.

Interpretations:

In the previously conducted MITRA-FR study, transcatheter mitral valve repair was not found to reduce hospitalizations due to heart failure or lower mortality from any cause. In contrast, the COAPT study demonstrated that transcatheter mitral valve repair not only reduced heart failure-related hospitalizations but also decreased all-cause mortality compared to medical therapy. Although there were differences in patient selection criteria between the two studies, the results led to confusion in clinical practice. The RESHAPE-HF2 study, while not showing a difference in all-cause mortality between the device and control groups, indicated that transcatheter mitral valve repair may become more prominent in clinical practice due to its significant reduction in heart failure-related hospitalizations.