Mitral transcatheter edge-to-edge repair and outcomes according to baseline health status: the RESHAPE-HF2 trial

Clinical Snapshot

Key Findings

• P Value: P-trend = 0.53 for interaction across tertiles

• Effect Size: 50% relative risk reduction in middle tertile (KCCQ 38.9-66.1), smaller effects in other tertiles

• Primary Outcome: Cardiovascular death or heart failure hospitalisation showed hazard ratios of 0.71, 0.50, and 0.73 across KCCQ tertiles

• Nnt Or Sensitivity: Odds ratios for KCCQ improvement: 3.38 for ≥5-point, 3.12 for ≥10-point, 3.25 for ≥15-point improvement

• Confidence Interval: HR 0.50 (0.29-0.85) for middle tertile, others cross 1.0

Clinical Application

Requires specialised cardiac catheterisation facilities and trained interventional cardiologists; available in major Australian cardiac centres MitraClip is TGA-approved and available through private health insurance; may require case-by-case PBS consideration for public patients; aligns with CSANZ heart failure guidelines for selected patients Australian patients with symptomatic heart failure and moderate-to-severe secondary mitral regurgitation who remain symptomatic despite optimal medical therapy

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% <.20 cm2). The impact of baseline KCCQ-clinical summary score (CSS) on the effect of M-TEER on clinical outcomes was assessed using Cox proportional hazards models. Changes post-randomization in health status and responder analyses were performed to assess the odds ratio (OR) of improvement and deterioration in KCCQ scores. RESULTS: Among 505 patients, M-TEER reduced cardiovascular death or HF hospitalization risk [hazard ratio (HR): .71 (.48-1.05), .50 (.29-.85), and .73 (.38-1.41)] across KCCQ-CSS tertiles of <38.9, 38.9-66.1, and >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.

References

1. 1.Butler, J., Khan, M. S., Friede, T., Placzek, M., Greenberg, B., Coats, A. J. S., Rosano, G., Abraham, W. T., Anker, M., Diek, M., Genis, A. B., Filippatos, G., Metra, M., Ninios, V., Spargias, K., Hasenfuß, G., Ponikowski, P., von Bardeleben, R. S., & Anker, S. D. (2026). Mitral transcatheter edge-to-edge repair and outcomes according to baseline health status: the RESHAPE-HF2 trial. European Heart Journal. https://doi.org/10.1093/eurheartj/ehaf1035