Greater Treatment Options for AVS Patients with a Lower Surgical Risk of Major Complications

Last month, the U.S. Food and Drug Administration (FDA), an agency within the U.S. Department of Health and Human Services, that protects the public health, approved an expanded indication for several transcatheter heart valves to include patients with severe aortic valve stenosis (Sapien 3, Sapien 3 Ultra, CoreValve Evolut R and CoreValve Evolut PRO) at low surgical risk associated with open-heart surgery to replace the damaged valves.

For low risk patients, open-heart surgery has been the standard-of-care for aortic valve replacement. However, the procedure to insert a transcatheter heart valve is less invasive, and involves a smaller incision and shorter recovery time than open-heart surgery.


The incidence of aortic valve stenosis increases with age. As the aortic valve opening narrows, the heart must work harder to pump blood to the body. Occurring in about 3 percent of Americans over age 75, severe aortic valve stenosis can cause fainting, chest pain, heart failure, irregular heart rhythms (arrhythmias), cardiac arrest or death. Patients with severe aortic valve stenosis generally need to undergo heart valve replacement to improve blood flow through their aortic valve.

According to FDA, the federal agency is the first medical products regulatory body in the world to expand the indication for transcatheter aortic valve replacement (TAVR) to this patient population. As part of the approval process, manufacturers are required to continue to follow patients enrolled in their randomized studies for 10 years to further monitor safety and effectiveness, including long-term valve durability. Additionally, manufacturers are required to participate in the Society of Thoracic Surgeons American College of Cardiology Transcatheter Value Therapy (STS/ACC TVT) Registry to provide the FDA with additional monitoring of these devices over a 10-year period.

FDA says that the transcatheter heart valves \”should not be used in patients who cannot tolerate blood thinning medications or 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 notes that the long-term durability of transcatheter heart valves compared to 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.

Like open-heart valve replacement surgery, treatment with transcatheter heart valves is associated with a potential risk of serious complications, notes the FDA, noting that serious complications associated with the uses of these devices include death, stroke, acute kidney injury, heart attack, bleeding, and the need for a permanent pacemaker.

Evolving Treatment for Aortic Stenosis

\”The treatment paradigm for aortic stenosis has evolved from a discussion about risk of surgery to one where anatomy really will dictate the choice between TAVR and SAVR,\” says ACC Surgeons\’ Council member Joseph Cleveland, MD, FACC in a statement issued on August 16, 2019.  \”For most patients, the preferred treatment will be TAVR unless specific conditions like concomitant multivessel coronary artery disease, the presence of an aortic aneurysm or aortic root anatomy which is not suitable for a TAVR exist,” notes Cleveland.

Adds Bram Zuckerman, M.D., director of the Office of Cardiovascular Devices in the FDA’s Center for Devices and Radiological Health, “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,” he says.

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,” says Zuckerman.

“The FDA\’s recent approval of TAVR now allows access for all patients with aortic stenosis to have greater treatment options with a lower risk of major complications. Clearly optimal treatment for patients will continue to include a heart team approach to assist patients in choosing the most appropriate therapy for treatment of their aortic stenosis,\” says Cleveland.

Earlier this year, results of the landmark PARTNER 3 and EVOLUT trials presented at ACC.19 in New Orleans and simultaneously published in the New England Journal of Medicine showed outcomes after TAVR were superior or at least as good as those following surgical aortic valve replacement (SAVR) among patients with severe aortic stenosis at low surgical risk.

In June, the Center for Medicare and Medicaid Services finalized regulatory revisions to the national coverage determination that governs coverage of TAVR. That coverage was written to change with future indications revisions, so TAVR is covered when an FDA-approved complete aortic valve and implantation system is used for that system\’s FDA-approved indication.


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