Heart Failure Shunt Device Shows Mixed Safety Results
Patients with preserved ejection fraction faced higher adverse event risks in a new two-year clinical study.
Updated on Oct. 27, 2026 in Heart Disease
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Results from the two-year RELIEVE-HF trial show divergent outcomes for heart failure patients receiving an interatrial shunt. While the device remained highly durable, those with heart failure with preserved ejection fraction (HFpEF) faced increased risks of adverse events.
Why it matters
The study highlights critical differences in how patient subgroups respond to interatrial shunting, identifying potential safety concerns for the HFpEF population. These findings emphasize the importance of careful patient selection when considering device-based heart failure treatments.
In a randomized clinical trial of 508 patients, researchers assessed the safety and durability of an interatrial shunt device over two years. The results indicate high procedural success and long-term patency, but reveal higher rates of serious adverse events and renal function decline in HFpEF patients compared to those in the sham group.
The players
JACC: Heart Failure
A peer-reviewed medical journal focused on clinical research and advancements in the management of heart failure.
The details
The interatrial shunt works by creating a controlled opening between the heart's atria to manage pressure, which can alleviate symptoms in certain heart failure patients. While researchers achieved a 99.7 percent implantation success rate and maintained patency in 99.4 percent of patients over two years, the device appears to affect hemodynamics differently depending on the type of heart failure. In patients with HFpEF, the procedure was associated with significant declines in renal function, marked by a 6.0 mL/min/1.73 m² drop in eGFR, and higher rates of major bleeding.
Timeline
30 days after the procedure, no device-related MACNE were observed in the initial report.
12 months post-implantation, renal function changes were identified in HFpEF patients.
2 years of follow-up provided the final data on device safety and durability.
October 15, 2026, the study was published in JACC: Heart Failure.
Health Landscape
The RELIEVE-HF trial provides essential data for the ongoing evaluation of interatrial shunt devices, which represent a departure from traditional pharmacologic heart failure management. These findings help define the limits of device efficacy as the field seeks to personalize interventions based on specific heart failure subtypes.
Patients currently exploring device-based therapies for heart failure should discuss these specific safety findings with their cardiologist to determine if their heart failure subtype influences their individual risk profile. It is especially important to monitor renal function and watch for signs of bleeding if considering an interatrial shunt procedure.
The takeaway
While interatrial shunts demonstrate durability for some heart failure patients, the increased safety risks for those with HFpEF suggest that treatment paths must be highly tailored. Discuss your specific heart failure classification and potential device risks with your physician before planning any interventional procedures.
Further reading
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