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Use of TAVR System Expanded to Include Aortic Valve-in-Valve Replacement
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The FDA has expanded approved use of the CoreValve system to include aortic valve-in-valve replacement to patients in need of tissue aortic valve replacement who are also at high or extreme risk for complications associated with traditional open-heart surgery, according to a press release.
The expanded approval was based on FDA review of data from a U.S. clinical trial of 143 participants. Results showed an estimated rate of survival without major stroke of 95.8% at 30 days and 89.3% at 6 months after aortic valve-in-valve replacement. Medtronic will continue to follow these study participants for up to 5 years in a required post-market study to assess long-term performance of the device.
According to the FDA, aortic valve-in-valve replacement using the CoreValve should be limited to the stated patient population. The decision regarding whether the product and procedure are appropriate should only be made after careful evaluation by a heart team, including a cardiologist and a cardiac surgeon.
The FDA previously approved theCoreValve System for use in patients with aortic stenosis and who are considered at extreme or high risk for surgical aortic valve replacement. – by Katie Kalvaitis
Perspective
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Peter C. Block, MD
Valve-in-valve replacement has been around for quite some time, but has been used off-label. The major upside of having this expanded FDA approval is that it makes the reimbursement issue less of a problem. Valve-in-valve replacement is now, for the aortic position, something we can do ‘routinely’ without having to worry or clarify the use beforehand with CMS or other insurers to make sure that it is covered. The downside is that the CoreValve can rarely be used in other places because of its length and structure — for example, placed in a failing tissue mitral valve.
An important point is that the CoreValve is only approved for use in very high risk patients or patients who are not operative candidates. It is also important that its use be reviewed for appropriateness with a heart team.
The other good news is that, moving forward, we will also have an ongoing registry from Medtronic of the Corevalve patients for which FDA approval was given. That will help to determine the long-term effectiveness of Corevalve in a valve-in-valve position.
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