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FDA: Use of TAVR system expanded to include aortic valve-in-valve replacement
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The FDA has expanded the approved use of the CoreValve system to include aortic valve-in-valve replacement, according to an agency press release.
The new approval expands the authorized use of the transcatheter aortic valve replacement system (Medtronic) 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 the release.
The expanded approval for aortic valve-in-valve replacement was based on FDA review of data from a U.S. clinical trial of 143 participants. Results demonstrated that the estimated rate of survival without major stroke after aortic valve-in-valve replacement with this device was 95.8% at 30 days and 89.3% at 6 months. Risks with the procedure observed in the clinical trial included death, stroke, acute kidney injury, MI, bleeding, need for a permanent pacemaker and other complications, according to the release.
Medtronic will continue to follow these study participants for up to 5 years in a required post-market study to assess the long-term performance of the device.
According to the FDA, aortic valve-in-valve replacement using the CoreValve system should be limited to patients who need replacement of a failed tissue aortic valve but are at high risk for death or serious complications. Furthermore, the decision regarding whether the product and procedure are appropriate for a particular patient should only be made after careful evaluation by the patient’s heart medical team, including a cardiologist and a cardiac surgeon.
The FDA previously approved the CoreValve system for use in patients with aortic stenosis and who are considered at extreme or high risk for surgical aortic valve replacement.
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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