The US Food and Drug Administration (FDA) has expanded the indication for several transcatheter heart valves to include patients with severe aortic valve stenosis who are at low risk for death or major complications associated with open-heart surgery to replace the damaged valves.
These transcatheter valves — the Sapien 3 and Sapien 3 Ultra from Edwards Lifesciences and the CoreValve Evolut R and CoreValve Evolut PRO from Medtronic CoreValve LLC — were previously indicated only for patients at intermediate or higher risk for death or major complications during open-heart surgery.
“This new approval significantly expands the number of patients that can be treated with this less invasive procedure for aortic valve replacement and follows a thorough review of data demonstrating these devices are safe and effective for this larger population,” Bram Zuckerman, MD, director of the Office of Cardiovascular Devices in the FDA’s Center for Devices and Radiological Health, said in a statement.
“As the FDA assesses new medical technologies or expanded uses for previously approved products such as these, the agency remains committed to evaluating evidence from clinical trials and real-world clinical data in both the premarket and postmarket settings to ensure patients have access to high-quality, safe, and effective medical devices,” said Zuckerman.
The expanded indications follow data from two clinical trials of transcatheter aortic valve replacement (TAVR) in low-surgical-risk patients, which showed impressive outcomes compared with surgery.
The trials were presented in March at the American College of Cardiology Annual Scientific Session, with the presenters receiving a standing ovation after reporting their data, as reported by theheart.org | Medscape Cardiology.
The two trials showed remarkably similar results.
The PARTNER 3 trial, which used the SAPIEN 3 system, showed a significantly lower rate of the primary end point — a composite of death, stroke, and rehospitalization at 1 year — compared with surgery.
The other trial of the self-expanding valve CoreValve/Evolut R/Evolut PRO showed noninferiority compared with surgery in an interim Bayesian analysis of the primary end point — death from any cause or disabling stroke at 24 months — as well as significantly lower rates of disabling stroke and hospitalization for heart failure at 1 year.
“Two separate groups using two separate valves have come to very similar conclusions. This does not double the acceptability, it quadruples it,” Eugene Braunwald, MD, Brigham and Women’s Hospital, Boston, commented at ACC.19.
The transcatheter heart valves should not be used in patients who cannot tolerate blood thinners or who have an active infection in the heart or elsewhere. Additionally, the CoreValve Evolut R and CoreValve Evolut PRO devices should not be used in patients who have sensitivity to titanium or nickel, the FDA says.
The agency also said the long-term durability of transcatheter heart valves compared with surgically implanted valves has not been established. “Patients, especially younger ones, should discuss available treatment options with their heart care team to select the therapy that best meets their expectations and lifestyle,” the FDA advises.
As part of the approval of these devices for low-risk patients, the FDA is requiring the manufacturers to continue to follow patients enrolled in the randomized studies for 10 years to further monitor transcatheter aortic valve safety and effectiveness, including the long-term valve durability.
The manufacturers will also participate in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry to provide the FDA with additional surveillance of these devices over a 10-year period.
The FDA granted the expanded indications using the Premarket Approval (PMA) pathway, which is the most stringent type of device marketing application required by the FDA and is based on a determination by the FDA that the PMA application contains “sufficient valid scientific evidence to provide reasonable assurance that the device is safe and effective for its intended use(s).”