Transcatheter aortic valve replacement, or TAVR, is a minimally invasive alternative to open heart surgery for patients who require replacement of their aortic valve due to severe aortic stenosis. Although previously available only to patients at high or intermediate surgical risk, in August the Food and Drug Administration approved both of the latest-generation TAVR valves for use in patients at low surgical risk. This is a large group of patients who are typically younger and/or more active than those at higher risk. Until now these patients' only option was open heart surgery.
The expanded FDA approval is based on excellent performance of transcatheter valves in two recent landmark trials: the PARTNER 3 Trial, which evaluated Edwards Lifesciences' Sapien 3 valve, and the Evolut Low Risk Trial, which evaluated Medtronic's CoreValve Evolut system. In both trials, the TAVR valves had excellent safety profiles when compared to surgery and even achieved superiority in some clinical endpoints.
The next generation of TAVR valves are already well into development, so we should expect yet another improvement in performance of this technology.
Although the widespread availability of minimally invasive aortic valve replacement is welcome, this does not mean that surgery will no longer have a role. Sometimes surgically-implanted mechanical valves will still be preferred for their long-term durability. Or a patient may have anatomy better suited to a surgical approach. Patients requiring valve replacement should have a discussion with their heart team to select the best option for their needs.
Patrick Proctor MD practices cardiology with Heart South.
You may not be getting all you can out of your browsing experience
and may be open to security risks!
Consider upgrading to the latest version of your browser or choose on below: