Heart failure & cardiomyopathiesCohort study
Interatrial Shunt Therapy in Advanced Heart Failure: Outcomes from the Open-Label Cohort of the RELIEVE-HF Trial
- Single-arm open-label cohort study (roll-in cohort of the RELIEVE-HF trial)
- 64 sites
- prespecified performance goal
Authors' conclusion
Interatrial shunting with the Ventura device was safe and resulted in favourable clinical effects in patients with HF, regardless of LVEF. Improvements of left and right ventricular structure and function were consistent with reverse myocardial remodelling.
Study context
- Population
- Symptomatic heart failure (HF) despite optimal guideline-directed medical therapy (GDMT) with ≥1 HF hospitalization in the prior year or elevated natriuretic peptides
- Participants
- 97 participants
- Outcome
- Device-related major adverse CV or neurological events, vs prespecified performance goal
- Follow-up
- 30 days
Main finding
As reported in the abstract
Device-related major adverse CV or neurological events (safety endpoint)
Safety endpoint achieved vs prespecified performance goal; event rate
0%
P vs performance goal
p < 0.001
Observational data: associations, not effects.
Further findings
Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary score · 1, 3, 6 and 12 months
- Improved by 12-16 points at all follow-up timepoints
- all p < 0.004
- Similar outcomes in reduced and preserved left ventricular ejection fraction (LVEF)
TTE LV and RV structure and function · 12 months
- LV end-systolic volume reduced
- P = 0.020
- LV end-diastolic volume reduced
- P = 0.038
- LVEF improved
- P = 0.009
- RV end-systolic area reduced
- P = 0.001
- RV end-diastolic area reduced
- P = 0.030
- RV fractional area change improved
- P < 0.001
- Tricuspid annular plane systolic excursion improved
- P < 0.001
Original publication
Interatrial Shunt Therapy in Advanced Heart Failure: Outcomes from the Open-Label Cohort of the RELIEVE-HF Trial. Eur J Heart Fail. Published 1 April 2024. doi:10.1002/ejhf.3215
Summarised from the published abstract; every number is checked against it