Vanderbilt Heart and Vascular Institute (VHVI) has implanted its first V-Wave, an interatrial shunt device, as a part of a multi-center clinical trial.
The device could mark a paradigm shift in treating advanced heart failure patients with elevated left atrial pressure, or LVEDP, said Christopher Ellis, MD, associate professor of Medicine, who implanted the device.
The V-Wave is intended for heart failure patients who have swelling issues and difficulty breathing due to fluid buildup in their lungs, leading to hospitalizations and heart failure, Ellis said. The conventional method to treat such patients is with medication to relieve the fluid.
“If they are end-stage, that’s when they’re going to end up in our heart failure and transplant program for an LVAD or transplant,” Ellis said. “But this is a potential treatment for people to unload the fluid issues in the lung by basically creating a little shunt between that left atrium and right atrium so blood doesn’t back up into the lungs.”
Installing the funnel-shaped device, 5 mm in size, requires a minimally invasive 20-minute procedure using a catheter inserted into a vein.
In the trial, some patients will receive the device while others in a control group will not.
Patients will be tracked to see who does better — people with the device or without. The study will examine patient quality of life and dyspnea, or shortness of breath, said Lynn Punnoose, MD, assistant professor of Medicine and heart failure physician on the trial.
Further heart failure patients are being recruited for the clinical trial. For more information, contact Kathy Adams at 615-322-9845.
Punnoose emphasized that the trial is accepting patients regardless of ejection fraction, how much blood the heart pumps with each beat, a common measure of heart function.
“Our hope is that we can identify and improve symptoms in patients and reduce the frequency of hospitalizations by using this device in targeted patients,” she said. “We are trying to screen and identify the patients who could benefit from this.”
