Interatrial Shunt Treatment for Heart Failure: The Randomized RELIEVE-HF Trial

Area of Science:

• Cardiology
• Interventional Cardiology
• Heart Failure Management

Background:

• An interatrial shunt aims to decrease left atrial pressure and improve heart failure (HF) symptoms and prognosis.
• This study investigates the efficacy and safety of transcatheter interatrial shunt implantation in HF patients.

Purpose of the Study:

• To evaluate the safety and effectiveness of transcatheter interatrial shunt implantation in patients with symptomatic HF.
• To assess outcomes stratified by left ventricular ejection fraction (LVEF) status (reduced vs. preserved).

Main Methods:

• Randomized controlled trial comparing interatrial shunt implantation to a placebo procedure in 508 HF patients.
• Patients were stratified by LVEF (≤40% reduced, >40% preserved).
• Primary safety assessed by major adverse events at 30 days; primary effectiveness by a hierarchical composite outcome over 2 years.

Main Results:

• No primary safety events occurred; shunt implantation was safe (1.5% upper confidence limit).
• No significant difference in the 2-year primary effectiveness outcome between shunt and placebo groups (win ratio 0.86, P=0.20).
• Patients with reduced LVEF showed fewer cardiovascular events with shunt treatment (RR 0.55, P<0.0001), while those with preserved LVEF had more events (RR 1.68, P=0.0001).

Conclusions:

• Transcatheter interatrial shunt implantation is safe but does not improve overall HF outcomes.
• Exploratory analysis suggests potential benefit in reduced LVEF HF patients and harm in preserved LVEF HF patients.