December 3, 2025European Heart Journal4 citationsOpen Access
View Full PaperMitral transcatheter edge-to-edge repair and outcomes according to baseline health status: the RESHAPE-HF2 trial
Key Result
M-TEER showed a consistent trend towards lower risk of CV death or HF hospitalization across baseline health status tertiles (HRs 0.71, 0.50, 0.73; P-trend=0.53) and improved KCCQ scores.
Study Design
Type
RCT (n=505)
Structured PICO
Does mitral transcatheter edge-to-edge repair improve clinical outcomes and health status compared to medical therapy alone in patients with symptomatic heart failure and moderate-to-severe ventricular secondary mitral regurgitation across different baseline health status levels?
P
Population
505 patients with symptomatic heart failure and moderate-to-severe ventricular secondary mitral regurgitation, followed for up to 24 months.
I
Intervention
Mitral transcatheter edge-to-edge repair (M-TEER) using the MitraClip device
C
Comparator
Medical therapy alone
O
Outcome
Cardiovascular death or heart failure hospitalization risk across baseline KCCQ-CSS tertiles, and changes post-randomization in health status (KCCQ scores)composite
M-TEER improves health status and consistently reduces the risk of heart failure hospitalization or cardiovascular death regardless of baseline health status in patients with heart failure and moderate-to-severe secondary mitral regurgitation.
Main Result
Effect estimate: HR 0.71, 0.50, and 0.73 (95% CI 0.48-1.05, 0.29-0.85, 0.38-1.41)
p-value: p=0.53
Abstract
BACKGROUND AND AIMS: Mitral transcatheter edge-to-edge repair (M-TEER) using the MitraClip device improves clinical outcomes in patients with moderate-to-severe ventricular secondary mitral regurgitation (vSMR) and heart failure (HF). This study evaluated whether the effects of M-TEER on clinical outcomes vary by baseline health status, as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ), and assessed the impact of M-TEER on health status post-randomization. METHODS: The RESHAPE-HF2 trial included patients with symptomatic HF and moderate-to-severe vSMR (mean effective regurgitant orifice area .25 cm2; 14% >.40 cm2, 23% 66.1, respectively (P-trend = .53). Similar results were seen for total HF hospitalization (P-trend = .48). M-TEER improved KCCQ-CSS, total symptom score, and overall summary score at 1, 6, 12, and 24 months compared to medical therapy alone (P < .05 at all time points). More patients in the M-TEER arm experienced a ≥5-point OR 3.38 (2.09-5.45), ≥10-point OR 3.12 (1.93-5.02), and ≥15-point OR 3.25 (1.94-5.45) improvement, and less patients had a ≥5-point deterioration OR .34 (.19-.57) in KCCQ-CSS at 6 months. Similar results were seen across other KCCQ domains and all time points. CONCLUSIONS: In patients with HF and moderate-to-severe vSMR, M-TEER showed a consistent trend towards a lower risk of HF hospitalization, with or without cardiovascular death, across all KCCQ-CSS tertiles and improved health status over time.