Innovative Heart Valve Fix Still Ticking at 5 Years

When Columbia interventional cardiologist Martin Leon, MD, first started exploring the idea of replacing diseased heart valves by using a tube threaded through an artery in the leg, the notion garnered more than a few skeptical remarks.  Some experts called it crazy; others pointed to seemingly insurmountable challenges.

The naysayers were wrong. Since its first introduction in a patient just over 20 years ago, transcatheter aortic valve replacement (TAVR) has changed the way aortic stenosis, a disease of the heart’s aortic valve, is treated. From experimental device to niche therapy for the sickest of the sick to an increasingly popular option for the majority of patients with aortic stenosis who need a new aortic valve, the minimally invasive procedure is now performed more often than the traditional open-heart method.

The latest iteration consists of a bioprosthetic valve mounted inside a cobalt-chromium frame which is then tightly crimped and tucked into a narrow tube. The tube, or catheter, is threaded up through the femoral artery to the aortic valve. Once the artificial valve is in place, a balloon is used to expand the frame, implanting it within the diseased valve, and the catheter is withdrawn.

Leon has been at the center of this medical revolution, leading several sequential landmark trials that showed TAVR is successful in a range of patients. First, those too frail to endure surgery, then those at high- and intermediate-risk of surgical complications.

Extending TAVR to more patients

The culmination of that effort was PARTNER 3, an ongoing trial that compares TAVR and traditional surgery among patients who are considered good candidates for traditional surgery.  

Initial results from PARTNER 3, presented in 2019, showed that after one year, TAVR patients were doing a bit better than surgical patients. And later the same year, the FDA approved TAVR for use in patients who are good candidates for surgery, who make up about 80% of aortic stenosis patients who need a new valve.

Since then, TAVR cases have increased rapidly. But as TAVR has become more common in younger patients with longer life expectancies, durability of the implanted valve has become an important question to resolve.

Five-year data from PARTNER 3—just published this October in the New England Journal of Medicine—should be reassuring for these patients and their doctors. TAVR was shown to be just as safe and durable as traditional surgical replacement in the first five years after the procedure.

“It’s superb data,” says Leon. “The fact that we were able to achieve results that are essentially equivalent to our surgical colleagues tells me that this is a meaningful alternative to open-heart surgery. We can tell our patients that if they have low risk and severe aortic stenosis, there’s a more than 85% chance they’ll be alive with a durable heart valve with either therapy.”

What’s next?

PARTNER 3 will continue for another five years to determine any differences between the treatments out to a decade.

And at Columbia, an interdisciplinary team continues to hone the TAVR technique, refining both the procedure and the accompanying technology with the goal of making TAVR available to more patients.

Though his team has performed thousands of TAVR procedures at Columbia, Leon is anything but jaded.

“It’s a magical experience,” he says. “I haven’t tired of the excitement. Every time you implant one of these transcatheter valves, the dramatic effect it has on the patient in the first 30 days is unlike anything we’ve ever done before. These patients are transformed.”