Feb. 1 (UPI) — People with the commonest form of heart failure may perhaps benefit a new, minimally unpleasant cardiac implant device, specially if they exercise, a study publicised Tuesday by the Lancet found.
The device, called an atrial shunt, was found in clinical trials to be more effective at improving blood flow in the heart in people with preserved ejection fraction, or diastolic, heart failure, following 20 watts, or moderate levels, of exercise, the data showed.
In addition, the device was found to be safe and to improve heart function in people with this common form of heart failure, the researchers said.
Developed by Corvia Medical, the device is being evaluated in trials and has not been approved for use by the Food and Drug Administration.
“We found that what happens in the heart and lungs during exercise is of prime importance in this type of heart failure,” study co-author Dr. Sanjiv Shah said in a press release.
Following atrial shunt implantation, “patients with [diastolic heart failure] who are able to relax the blood vessels in their lungs appear to do well with the device,” said Shah, director of the diastolic heart failure program at Northwestern University in Chicago.
Conversely, “those whose blood vessels can’t relax appear to do worse,” he added.
When the heart has difficulty relaxing between beats, it is unable to fill completely, which means it will pump less blood to the rest of the body, according to Harvard Medical School.
This leads to diastolic heart failure, which affects about 3 million people in the United States, the American Heart Association estimates, making it the most common form of heart failure nationally.
Specifically, diastolic heart failure occurs when the left ventricle is unable to relax, which limits the amount of blood flowing into the heart, causing fluid to build up in the lungs, Shah and his colleagues said.
It leads to symptoms such as shortness of breath, fluid retention, irregular heartbeat and exercise intolerance, or the inability to engage in a healthy level of physical activity, they said.
An atrial shunt is a small, hollow tube, that is inserted into the atrium of the heart to improve blood flow, according to Shah and his colleagues.
Unlike stents, which are placed in the arteries that transport blood to the heart, atrial shunts are inserted directly into the organ, effectively connecting the left and right atria, Shah and his colleagues said.
It is inserted through a catheter, creating a small hole between the left and right atriums of the heart to allow blood to flow from the stiff left atrium to the normal right atrium, the researchers said.
This can lower pressure in the left atrium and reduce the effects of diastolic heart failure, they said.
Measuring its effectiveness during and after moderate levels of physical activity can give physicians a better idea of how well the device is working to improve heart function, according to the researchers.
“This has potential to change the way we evaluate patients with this condition and should guide how future clinical trials are conducted and the criteria for enrollment,” Shah said.
“This simple, one-time procedure could reduce hospitalizations and significantly improve quality of life,” he said.
Workout key to effectiveness of new component for heart failure, exploration finds
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