Transcatheter aortic valve replacement (TAVR) surgery has typically targeted patients considered too risky to undergo open-heart surgery. But in mid-August, TAVR’s scope was substantially expanded due to the U.S. Food & Drug Administration’s (FDA) approval of the procedure for low-risk patients using four TAVR systems: Medtronic’s CoreValve Evolut R and Evolute PRO and Edwards Lifesciences’ Sapien 3 and Sapien 3 Ultra.

“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, M.D., director of the Office of Cardiovascular Devices in the FDA’s Center for Devices and Radiological Health, said in a press 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.”

The Evolut Low Risk Trial evaluated three valve generations—CoreValve, Evolut R, and Evolut PRO—in more than 1,400 patients. TAVR was shown to be an effective treatment option in low-risk patients, with shorter hospital stays and higher quality-of-life scores compared to surgical valve aortic replacement (SAVR). At 30 days, the Evolut TAVR achieved a significantly lower rate of the composite cause of all-cause death or disabling stroke and demonstrated superior blood flow performance compared to SAVR.

“Low-risk patients were younger and healthier than those patients enrolled in our prior studies, and were better able to weigh the risks and benefits of surgery or TAVR based on their value preferences,” said Jeffrey J. Popma, M.D., director of Interventional Cardiology at Beth Israel Deaconess Medical Center in Boston, and co-principal investigator in the Evolut Low Risk Trial. “It is our impression that patients will now be able to make a choice on the method of aortic valve replacement based on an informed risk-benefit discussion with their heart team.”

Edwards’ Partner 3 Trial also compared the Sapien 3 system to open-heart surgery and achieved superiority. The event rate for the trial’s primary endpoint—a composite of all-cause mortality, all stroke, and rehospitalization at one year—was a 46 percent reduction. The data was presented in March at the American College of Cardiology’s 68th Annual Scientific Session and simultaneously published in The New England Journal of Medicine.

“The Partner 3 Trial demonstrated that low-risk patients treated with the Sapien 3 TAVR experienced extraordinary outcomes with 1 percent rates of death or disabling stroke at one year, a short length of stay and 96 percent discharged to home or self-care. Sapien 3 is the only valve to achieve superiority over surgery based on the prespecified primary endpoint,” said Martin B. Leon, M.D., director of the Center for Interventional Vascular Therapy at NewYork-Presbyterian/Columbia University Medical Center, professor of medicine at the Columbia University College of Physicians and Surgeons, and co-principal investigator of the Partner 3 Trial.

Though the FDA has now green-lighted TAVR for patients of all risk profiles, no cardiac procedure is without risk. A few days after granting the approvals, the FDA announced that Edwards began recalling Sapien 3 Ultra’s delivery system on July 9. Edwards initiated the recall following reports of burst balloons during implantation, which resulted in significant difficulty retrieving the valve into the catheter and withdrawing the system. When Edwards initiated the recall, 17 injuries and one death had been reported due to the burst balloons. Edwards added a warning to Sapien 3 Ultra’s Instructions for Use instructing surgeons to inflate the valve slowly and continuously throughout deployment to avoid balloon rupture.

Perhaps in preparation for the landmark approval, the Centers for Medicare & Medicaid Services (CMS), finalized its update of the national coverage policy for TAVR in late June. The decision states TAVR is covered for treating symptomatic aortic valve stenosis “when furnished according to” an FDA-approved indication, and when all of the specific conditions are met. The valve and delivery system must have received FDA premarket approval for the system’s approved indication, which Medtronic and Edwards have now achieved for patients of any risk. The patient must also receive pre- and post-op care from a heart team that is “a cohesive, multi-disciplinary team of healthcare professionals,” including a cardiac surgeon and interventional cardiologist experienced in aortic stenosis treatment. They must have each examined the patient face-to-face and evaluated suitability for SAVR, TAVR, or palliative therapy and demonstrated the rationale for their judgment.

Hospitals providing TAVR must have “appropriate infrastructure that includes but is not limited to” onsite valve surgery and interventional cardiology programs and a post-procedure intensive care facility with personnel experienced in valve procedures. Hospitals beginning a TAVR program without previous experience must have, at least: 50 open heart surgeries in the year prior to program initiation, 20 aortic-valve-related procedures two years prior, two physicians with cardiac surgery privileges, at least one physician with interventional cardiology privileges, and 300 percutaneous coronary interventions per year.

Adding to the fray, Boston Scientific’s Lotus Edge TAVR gained FDA approval in April and Edwards discontinued work on its Centera valve in July to focus on Sapien 3. The treatment narrative is shifting, and TAVR is beginning to take the lead.