Sentara participating in clinical study testing small shunt for heart failure patients

Posted at 1:12 PM, Nov 16, 2020

NORFOLK , Va. - It's an epidemic that affects more than six million people in the U.S., and doctors diagnose 800,000 new cases each year.

"Heart failure is the number one cause of hospital admission in Medicare population," said Dr. David Baran, System Director with Sentara Advanced Heart Failure, Transplant and MCS.

Even with medication, those with heart failure have a poor prognosis and are highly symptomatic, with a huge majority experiencing shortness of breath, according to Baran.

"These are people that would consider intravenous medications at home or heart transplants or surgical heart pumps," said Baran,"typically people hospitalized once in the last year and ones we don't have another answer."

But now they may. A new device called a V-Wave Ventura® Interatrial Shunt is no bigger than a dime. Sentara is participating in a clinical trial called Relieve-HF, inserting a device to help patients with diastolic and systolic heart failure.

"I go in via a vein in the leg with another partner - all in all half an hour - and we insert pair of funnels, which prevents pressure from building up to the right side of the heart," said Dr. Baran.

Previously, that pressure and difficulty breathing leads to more than 90% of heart failure hospitalizations.

"These patients are a bit more fragile, and invasive techniques wouldn't be appropriate," he said.

Seventy-five different heart hospitals are participating in the clinical trial, but Sentara is the only site in Virginia testing the V-Wave shunt.

"It is great we can offer something only a few spots in United States can, and it means a better quality of life," he said.

The clinical research trial involves 500 patients.