Valvular & structural heart disease

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

Eur Heart JPublished Secondary analysis of the RESHAPE-HF2 randomised trial

Authors' conclusion

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.

Study context

Population
Patients with symptomatic heart failure (HF) and moderate-to-severe ventricular secondary mitral regurgitation
Participants
505 patients
Comparison
Mitral transcatheter edge-to-edge repair (M-TEER) vs medical therapy alone, by baseline KCCQ-CSS tertile
Primary endpoint
CV death or HF hospitalization, by baseline KCCQ-CSS tertile

Primary result

As reported in the abstract

CV death or HF hospitalization by baseline KCCQ-CSS tertile
M-TEER vs Medical therapy aloneHazard ratio (CI)
KCCQ-CSS <38.9
.71(.48-1.05)
KCCQ-CSS 38.9-66.1
.50(.29-.85)
KCCQ-CSS >66.1
.73(.38-1.41)

Further findings

OutcomeOR (CI)
KCCQ-CSS improvement/deterioration (responder analysis) · 6 monthsM-TEERvs Medical therapy alone≥5-point improvement3.38 (2.09–5.45)
KCCQ-CSS improvement/deterioration (responder analysis) · 6 monthsM-TEERvs Medical therapy alone≥10-point improvement3.12 (1.93–5.02)
KCCQ-CSS improvement/deterioration (responder analysis) · 6 monthsM-TEERvs Medical therapy alone≥15-point improvement3.25 (1.94–5.45)
KCCQ-CSS improvement/deterioration (responder analysis) · 6 monthsM-TEERvs Medical therapy alone≥5-point deterioration.34 (.19-.57)
  • KCCQ-CSS improvement/deterioration (responder analysis): Similar results across other Kansas City Cardiomyopathy Questionnaire (KCCQ) domains and all time points

Total HF hospitalization by KCCQ-CSS tertile

Similar results across tertiles
P for trend = 0.48

KCCQ-CSS, total symptom score, overall summary score · 1, 6, 12, and 24 months

Improved with M-TEER vs medical therapy alone at all time points
P < 0.05

Original publication

Mitral transcatheter edge-to-edge repair and outcomes according to baseline health status: the RESHAPE-HF2 trial. Eur Heart J. Published 19 December 2025. doi:10.1093/eurheartj/ehaf1035

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