Corvia Medical’s InterAtrial Shunt device is a flower-shaped wire device that creates a tiny hole between the upper chambers of the heart. It is designed to improve blood flow and help prevent continued weakening of the heart muscle. Doctors implant the device using a catheter inserted into the heart through an artery in the leg.
All 64 patients involved in the study, named REDUCED LAP-HF, reported fewer symptoms after receiving the device. They also had better exercise tolerance and higher quality of life at both the six-month and one- year intervals.
The study was released at the American Heart Association’s Scientific Sessions and published online in AHA’s journal Circulation: Heart Failure. Dr. David Kaye, Ph.D., the study’s lead investigator, said a randomized clinical trial comparing patients with the device to those without it will begin early next year.
This preliminary study suggests that the device may ultimately benefit heart failure patients. None of the patients involved noted any sort of safety concern, which adds to its overall promise. However, cardiologist Javed Butler, M.D. of Stony Brook University cautioned that the trial was relatively short. Thus, there is little information regarding the long-term pros and cons of puncturing a person’s heart. The cost of the procedure is also a concern.
Roughly half of people suffering with heart failure have HFpEF, the type that Corvia Medical’s device treats. People with HFpEF have symptoms such as lung congestion and breathing difficulties, even during basic, everyday activities. There is currently no effective treatment available for people with HFpEF.
According to the American Heart Association, about 5.7 million U.S. adults have heart failure, and nearly half die within five years of diagnosis.