FDA Expands Indication for Transcatheter Heart Valves

The FDA recently expanded the indication for Sapien XT and Sapien 3 transcatheter heart valves for patients with aortic valve stenosis who have intermediate risk of death or complications from open-heart surgery.

Previously, Sapien XT and Sapien 3 were only indicated for patients at high risk for death or complications during surgery. Aortic valve stenosis is caused by aging aortic valves that become narrow, and force the heart to work harder to pump blood through smaller openings.

This condition occurs in 3% of Americans over 75-years-old, and can cause fainting, chest pain, heart failures, arrhythmias, cardiac arrest, or death, according to the FDA. These patients typically need to undergo heart valve replacement surgery to improve blood flow.

Open-heart surgery is the standard treatment for intermediate risk patients, but involves a larger incision and longer recovery time compared with the procedure to insert a transcatheter heart valve. Intermediate risk patients have a risk of dying within 30 days of the surgery over 3%, the FDA stated.

The studies the approval for the expanded indication was based on involved patients with aortic stenosis who were at intermediate risk for complications. There were 1011 patients selected to have a transcatheter aortic valve replacement using the Sapien XT valve, while 1021 patients were selected for a traditional aortic valve replacement during open-heart surgery with a surgical tissue valve, according to the FDA.

In the second study, 1078 intermediate risk patients received the Sapien 3 valve. Both studies were said to demonstrate the safety and efficacy of both Sapien devices.

The side effects of the Sapien XT or the Sapien 3 valve are death, stroke, acute kidney injury, heart attack, bleeding, and the need for a permanent pacemaker, the FDA reported. The FDA is requiring that the manufacturer continue to follow patients in the clinical studies for 10 years to assess long-term safety and efficacy.

“This is the first time in the US that a transcatheter aortic valve has been approved for use in intermediate risk patients,” said Bram Zuckerman, MD, director of the division of cardiovascular devices at the FDA’s Center for Devices and Radiological Health. “This new approval significantly expands the number of patients indicated for this less invasive procedure for aortic valve replacement.”