Heart Failure Shunt Device Safety Results Released
The two-year RELIEVE-HF trial reveals mixed safety outcomes for patients receiving an interatrial shunt device.
Updated on Oct. 27, 2026 in Heart Disease
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Researchers published two-year safety and durability findings from the RELIEVE-HF clinical trial regarding an interatrial shunt device used to treat heart failure. The data shows distinct safety profiles for patients depending on their specific type of heart failure.
Why it matters
Understanding how interatrial shunt devices affect different patient populations is critical for assessing their long-term clinical viability. The varied outcomes between heart failure subtypes highlight the need for precision in selecting patients for this intervention.
The RELIEVE-HF trial randomized 508 patients to compare a shunt device against a sham procedure, finding the device remained open in 99.4 percent of cases through two years. However, HFpEF patients saw a 2.69 hazard ratio for all-cause MACNE and significant declines in renal function compared to the control group.
The details
While the shunt implantation success rate reached 99.7 percent, safety outcomes diverged sharply based on the patient's condition. HFrEF patients experienced fewer serious adverse events with the shunt, whereas HFpEF patients faced a higher incidence of major bleeding and serious complications compared to the sham group.
Timeline
No device-related MACNE were observed in the initial 30-day trial report.
Renal function changes were observed at 12 months in HFpEF patients.
Researchers followed up on device safety and durability for 2 years.
The study results were published in JACC: Heart Failure on October 15, 2026.
The Big Picture
This trial follows the rigorous data reporting standards established by the JACC: Heart Failure journal for the publication of cardiovascular device studies. It contributes critical long-term evidence to the evolving landscape of interatrial shunt therapy.
Patients with preserved ejection fraction heart failure should discuss these specific risks with their cardiologists before considering shunt procedures. Conversely, those with reduced ejection fraction may see a more favorable safety profile based on current trial data.
The takeaway
Clinical trial results underscore the importance of distinguishing between heart failure types when assessing new medical devices. Patients and providers should rely on granular safety data to weigh the potential benefits of surgical interventions against identified risks.
Further reading
Learn more about the latest research and advancements in cardiovascular care in our Heart Disease section.
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Should medical treatments be evaluated based on specific patient types rather than general populations?
