Heart failure & cardiomyopathiesRandomised controlled trial
Modeling Individual Patient Outcomes After Interatrial Shunt Treatment in Heart Failure With Reduced and Preserved Ejection Fraction: The RELIEVE-HF Trial
- randomized trials
- placebo procedure
- secondary analysis of the RELIEVE-HF trial
- risk modeling by the Lin-Wei-Yang-Ying method
Authors' conclusion
In RELIEVE-HF, distinct baseline risk factors influenced cardiovascular outcomes before and after atrial shunt treatment in HFrEF and HFpEF. Despite markedly different group responses to atrial shunt treatment in the randomized HFrEF and HFpEF strata, given individual differences in patient risk factor profiles, most but not all patients with HFrEF may benefit, and some patients with HFpEF may also improve after shunt treatment.
Study context
- Population
- Patients with heart failure with reduced and preserved ejection fraction randomized to interatrial shunt implantation versus a placebo procedure in the RELIEVE-HF trialpatients randomized · heart failure with reduced ejection fraction (HFrEF) 206 · heart failure with preserved ejection fraction (HFpEF) 302
- Participants
- 508 patients
- Comparison
- interatrial shunt implantation vs placebo procedure
- Primary endpoint
- all-cause death, cardiac transplantation or left ventricular assist device implantation, heart failure hospitalizations, and outpatient worsening heart failure events: independent baseline predictors
Primary result
As reported in the abstract
- Control patients with HFrEF: atrial fibrillation, elevated troponin, lower left ventricular ejection fraction, and greater right atrial pressure
- Shunt-treated patients with HFrEF: lower systolic blood pressure and elevated right ventricular end-diastolic area index, pulmonary artery pressure, and pulmonary vascular resistance
- Control patients with HFpEF: diabetes, higher heart rate and left ventricular end-systolic volume, and lower right ventricular fractional area change
- Shunt-treated patients with HFpEF: hypertension, smoking, lower 6-minute walk distance, reduced estimated glomerular filtration rate, elevated troponin, and moderate or greater tricuspid regurgitation
- 37 baseline covariates; cumulative mean function of recurrent events modeled by the Lin-Wei-Yang-Ying method
Further findings
Estimated share of patients who might benefit from shunt placement (risk modeling)
- HFrEF
- 67.2%
- HFpEF
- 21.4%
2-year clinical outcomes in the randomized trial (background)
- Improved in HFrEF
- Worsened in HFpEF
Original publication
Summarised from the published abstract; every number is checked against it