Researchers at the University of Virginia Health System in Charlottesville are evaluating the use of a valve pressure relief device meant to alleviate the severe shortness of breath associated with congestive heart failure as part of a clinical trial, The Daily Progress reports.
The device, an interatrial shunt, is a permanent implant that prevents the left ventricle from becoming backed up and placing pressure on the lungs by redirecting small amounts of blood from the left ventricle to the right ventricle.
"When you look at heart failure, the symptoms almost always include shortness of breath that is driven by pressure buildup in the heart, especially in the left side," said Sula Mazimba, MD, a UVA cardiologist working on study. "When pressure builds up, it has to go somewhere. With the shunt, it goes into the other side of the heart," he told the news outlet.
Researchers are evaluating the shunt's efficacy in patients with a number of cardiac conditions, including diabetes and hypertension, that can inhibit function of the heart muscles, Dr. Mazimba said.
The FDA has been reviewing the device since 2018, with a 2019 study showing patients with the shunt had a 33 percent lower mortality rate compared to those without it, according to The Daily Progress. The European Union approved the device in March.
Data from the clinical trial will be sent to the FDA for further review, researchers said.
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