Heart failure & cardiomyopathies
Long-Term Safety and Procedural Performance of an Interatrial Shunt for Heart Failure According to Ejection Fraction
Authors' conclusion
Interatrial shunt implantation was mechanically reliable and durable through 2 years. Safety outcomes differed by HF phenotype, with no evidence of excess clinical safety events in HFrEF but increased adverse events in HFpEF. These findings support phenotype-specific evaluation of interatrial shunt therapy. (REducing Lung congestion symptoms using the v-wavE shunt in adVancEd Heart Failure [RELIEVE-HF]; NCT03499236).
Study context
- Population
- Patients with heart failure in the RELIEVE-HF trial, stratified into heart failure with reduced ejection fraction (HFrEF) (left ventricular ejection fraction (LVEF) ≤40%) and heart failure with preserved ejection fraction (HFpEF) (LVEF >40%)randomized 508 · roll-in 97
- Participants
- 605 enrolled patients
- Comparison
- shunt vs sham control, stratified by LVEF into HFrEF and HFpEF
Methodological detailsprespecified stratification by left ventricular ejection fraction (LVEF), roll-in patients
- Prespecified stratification by left ventricular ejection fraction (LVEF)
- Roll-in patients
Primary result
As reported in the abstract
Implantation attempted
370
Successful
369
99.7%
Further findings
Device- or procedure-related MACNE among implanted patients with follow-up (n = 348) · through 2 years
- No device- or procedure-related MACNE
- 0%; 95% CI: 0%-0.9%
Shunt patency among implanted patients with follow-up (n = 348) · through 2 years
- Shunt patency
- 99.4% (95% CI: 97.9%-99.9%)
Safety in HFrEF (prespecified LVEF-stratified analysis)
- Not associated with excess all-cause MACNE, major bleeding, or renal decline and was associated with lower SAE burden
- Prespecified
Safety in HFpEF (prespecified LVEF-stratified analysis)
- Associated with higher all-cause MACNE, greater SAE burden, increased major bleeding, and greater renal decline
- Prespecified
Original publication
Summarised from the published abstract; every number is checked against it