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A Paradigm Shift in Cardiology

FDA Approves TAVR for Low-risk Patients Creates A Paradigm Shift in Cardiology
 FDA Approves TAVR valves for low-risk patients, TAVR now available for all patients with severe, symptomatic aortic stenosis

Left, an illustration of the beginning of deployment for a CoreValveEvolut self-expanding transcatheter aortic replacement (TAVR) valve. Right, an illustration of the final balloon expansion of an Edwards Lifesciences Sapien 3 TAVR valve. Both valves received simultaneous FDA clearance for use in low-risk surgical patients. Clearing this last hurdle now allows wide-spread use of minimally invasive TAVR in all patients who otherwise would need an open-heart surgical valve replacement. 

August 16, 2019 — In one coordinated move, the U.S. Food and Drug Administration (FDA) opened use of transcatheter aortic valve replacement (TAVR) to low-risk patients today. The low-risk patient population is the final surgical risk category to be approved for TAVR, a minimally invasive alternative to open-heart surgical valve replacement (SAVR), and includes patients who may be younger and more active than higher-risk patients. Both devices are indicated for patients with severe, symptomatic aortic stenosis (AS).

The expanded FDA indication was widely anticipated because of excellent clinical trial results. Clinical trial data to date have been outstanding, performing as well, or better, than SAVR in high-risk, intermediate-risk and low-risk patients. The approved use in low-risk patients paves the way for an even more rapid expansion, as experts widely expect the transcatheter-based procedure to begin replacing a large swath of surgical valve replacement volume in the next couple of years. 

Why it's done

Reardon's assessment that risk stratification for TAVR is becoming obsolete is a sentiment echoed at many cardiology conferences over the past couple years. Both cardiac surgeons and interventional cardiologists said the question has flipped from who should qualify for TAVR to who should qualify for surgery. The general consensus is that about 25 percent of patients will be better suited for surgery for various reasons, but 75 percent of aortic valve replacements will move to TAVR in the next few years.

The estimate is that 76 percent of aortic valve replacements will be done by TAVR by 2025, In a recent TAVR session at the Society of Cardiolvascular Computed Tomography (SCCT) 2019 meeting. He said clinical trial data curves show SAVR and TAVR are basically on top of each other. By most measures, TAVR is just as good or better than SAVR, he said.

Easing the Burden of Aortic Stenosis With TAVR

Severe aortic stenosis affects approximately 165,000 low risk patients per year in the U.S., Western Europe and Japan, occurring when the aortic valve becomes diseased (stenotic). The valve leaflets become stiff and thickened and have difficulty opening and closing, making the heart work harder to pump blood to the rest of the body and, therefore, impacting an individual’s daily activities. If left untreated, patients with severe aortic stenosis can die from heart failure in as little as two years.

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

“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.”

Like open-heart valve replacement surgery, treatment with transcatheter heart valves is associated with a potential risk of serious complications. The 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.

These devices were approved using the premarket approval (PMA) pathway. Premarket approval 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).

As part of the approval of these devices, the FDA is requiring each manufacturer to continue to follow patients enrolled in their 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 (STS/ACC TVT Registry) to provide FDA with additional surveillance of these devices over a 10-year period.

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The expanded FDA indication was widely anticipated because of excellent clinical trial results. Clinical trial data to date have been outstanding, performing as well, or better


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