Sentara Participating in Study of Novel Device that may Improve Heart Failure Symptoms

Sentara Healthcare today announced that it has joined a large clinical study (RELIEVE-HF) investigating the V-Wave Ventura® Interatrial Shunt, a novel medical device designed to help patients with advanced heart failure. For the first time, we have a device to help patients with diastolic and systolic heart failure which was not available before.

In severe heart failure, even with optimized medical therapy, the heart is not able to effectively deliver sufficient blood flow to the body and fluid pressure builds up in the heart, including in the left atrium. This elevated left atrial pressure directly backs up into the patient’s lungs, causing patients to have difficulty breathing. This issue leads to greater than 90% of heart failure hospitalizations.

“The RELIEVE-HF trial offers our patients an option when there are no other alternatives. It functions as an escape valve for the left atrium, allowing high pressure to be relieved by sending red blood to the right side of the heart,” said David Baran, M.D., System Director, Sentara Advanced Heart Failure, Transplant and MCS. “Use of this device allows patients to walk and exercise, and when pressure builds, the shunt takes the pressure off. The outcome is that patients may feel substantially better, and breathe easier. Sentara Healthcare is delighted to be able to bring this new advance to our patients, as part of the full spectrum of heart failure care, from medications to transplant, assist devices and the cutting edge of research.”

Heart failure is a serious global disease affecting more than 26 million people worldwide and more than 6 million people in the US alone with more than 800,000 new cases each year. Even with medication, patients with severe heart failure have a very poor prognosis and a large percentage of patients remain highly symptomatic. New therapies are needed to improve quality of life, exercise capacity, and life expectancy, and to reduce the high risk of hospitalization.

The RELIEVE-HF study is a global pivotal study designed to evaluate the safety, as well as the effectiveness of the V-Wave Ventura Interatrial Shunt in reducing heart failure symptoms and hospitalizations. The clinical trial will include patients with advanced heart failure who experience symptoms with minimal or no exertion regardless of what type of heart failure the patient has (systolic or diastolic heart failure). The trial will enroll about 500 patients at up to 120 sites worldwide.

Prior to joining the RELIEVE-HF clinical trial, Sentara Healthcare heart failure patient, Terry Busby was experiencing disabling shortness of breath even with just walking in his home to his bedroom. He was completely disabled due to this and his extensive back pain problems. Mr. Busby has since been transformed by the shunt and has experienced a remarkable improvement. Now three months out, he has no shortness of breath and is very grateful that his only issue is his back.