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A heart failure device that works by creating a small opening between the heart's upper chambers stays functional for up to 2 years, but its safety profile looks very different depending on the type of HF a patient has. In the RELIEVE-HF trial, patients with preserved ejection fraction (HFpEF) who received the shunt faced significantly higher rates of serious adverse events and major bleeding compared to a sham procedure. Those with reduced ejection fraction (HFrEF) fared better, even showing fewer total serious adverse events.
An interatrial shunt device — designed to relieve elevated left atrial pressure in heart failure (HF) patients by creating a small passage between the heart's upper chambers — demonstrated strong durability over 2 years, but its safety story is more complicated. Data from the RELIEVE-HF trial, published in JACC: Heart Failure, show that outcomes diverge sharply based on whether patients have HF with preserved ejection fraction (HFpEF) or reduced ejection fraction (HFrEF).
The shunt was successfully implanted in 99.7% of attempts and remained open in 99.4% of patients at 2-year follow-up. Among HFrEF patients, the device appeared safe and was even associated with fewer total serious adverse events compared to sham. But for HFpEF patients, the picture was concerning — they experienced significantly more major adverse cardiovascular or neurological events, major bleeding, and kidney function decline.
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Why it matters: These findings suggest that a one-size-fits-all approach to interatrial shunt therapy may be risky. Tailoring treatment decisions to a patient's specific HF phenotype could be critical to avoiding serious harm — particularly in the HFpEF population.
