Tags: Heart Disease | TAVR | aortic | valve | replacement | FDA

FDA OK's Broader Use of Heart Valve Procedure

FDA OK's Broader Use of Heart Valve Procedure

(Copyright DPC)

By    |   Thursday, 25 August 2016 02:19 PM

Government regulators have agreed to allow the use of an aortic valve replacement device, a decision that will enable more people to opt for the minimally invasive procedure instead of surgery. 

In its decision, the U.S. Food and Drug Administration (FDA) agreed to allow patients at intermediate risk to opt for transcatheter aortic-valve replacement, or TAVR. Previously, the minimally invasive procedure was reserved for patients considered too high risk or otherwise unsuitable for surgery.

“This is the first time in the U.S. that a transcatheter aortic valve has been approved for use in intermediate risk patients,” says Dr. Bram Zuckerman, director of the FDA’s division of cardiovascular device. The approval also “significantly expands the number of patients indicated for this less invasive procedure for aortic valve replacement,” he added, in a statement.

The device is used to replace the aortic valve in patients with aortic valve stenosis, a condition that occurs with age, in which the valve narrows, causing the heart to work harder to pump enough blood through a smaller opening.

The disorder occurs in about three percent of Americans over age 75 and can cause fainting, chest pain, heart failure, irregular heart rhythms (arrhythmias), cardiac arrest or death. Patients with severe aortic valve stenosis generally need to have a heart valve replacement to improve blood flow through their aortic valve.

Traditionally, open-heart surgery has been the "gold standard" for aortic valve replacement in intermediate risk patients, but it involves a larger incision and longer recovery time than the minimally invasive procedure used to insert the transcatheter heart valve.

About one-third of patients referred for open-heart surgery for aortic valve replacement fall into the “intermediate risk” category, which is defined as having a greater than three percent risk of dying within 30 days following surgery.

The FDA based its approval on two studies involving 2,033 patients at intermediate surgical risk. They were randomized into two groups, with one group receiving the TAVR device and the other undergoing valve replacement surgery. The outcomes demonstrated the minimally invasive procedure was as equally safe and effective as surgery, the FDA says

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The U.S. Food and Drug Administration has agreed to expand the usage of an aortic valve replacement device, which means more patients will be allowed to chose it instead of surgery.
TAVR, aortic, valve, replacement, FDA
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2016-19-25
Thursday, 25 August 2016 02:19 PM
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