At Temple Health, we pride ourselves on being a hub for innovation. That’s why it’s no surprise that we were the first academic medical center in the greater Philadelphia area to have performed a commercial procedure on a heart disease patient using the new Navitor valve. This device, which is used during the Trans-catheter Aortic Valve (TAVR) procedure, allows us to treat larger number of patients with aortic stenosis, or a narrowing of the heart valve, and to do so more safely and effectively.
“The TAVR procedure was first performed in 2012,” explains Marissa Pietrolungo, DNP, CRNP, Temple University Hospital’s Structural Heart Disease Nurse Practitioner and Program Coordinator. “It was originally intended only for high-risk aortic stenosis patients, or those who were considered ineligible for open-heart surgery, which is the traditional way to fix the aortic valve.”
When the TAVR procedure initially debuted, it could be performed using either one of two types of valves: the Edwards SAPIEN 3 or the Medtronic Evolut. “There are pros and cons to each,” says David M. Fiss, MD, Professor of Clinical Medicine at the Lewis Katz School of Medicine. “The SAPIEN 3 sits in the annulus of the patient’s stenotic aortic valve, while the Evolut is placed above the aortic annulus. The SAPIEN 3 is inflated by a balloon, whereas the Evolut is self-expanding.
“There are several factors that we consider when determining which valve is most appropriate for each patient’s unique anatomy,” Dr. Fiss continues. “Cardiac CT provides precise measurements of cardiac structures such as annulus size, annular calcification, height of the coronary artery origins above the native valve, coronary sinus size, and height, calcification, and diameter of the sinotubular junction. This information helps us tailor which valve and size are most appropriate for each individual patient.”
“It’s Like Goldilocks and the Three Bears”
When they learned a third type of valve was being developed, Temple’s Structural Heart Disease team was thrilled. “We were just so excited to have another option,” Pietrolungo explains. “It’s like Goldilocks and the three bears. Sometimes, a patient has too much calcium in their aortic valve, which means you don’t want to use the SAPIEN 3 balloon expandable valve. But you also don’t want to use the Evolut valve, because the amount of calcium would cause a leak around the valve post-procedure. For those patients, the Navitor valve would be just right: it’s self-expanding, but it has an active sealing cuff around the valve cage that can help with paravalvular leaks. Its frame also has a large cell design that helps facilitate access to the coronary arteries after the TAVR procedure has been performed.”
Brian O’Murchu, MD, FACC, Director of the Cardiac Catheterization Lab and Professor of Clinical Medicine at the Lewis Katz School of Medicine, echoes Pietrolungo’s observations about the Navitor valve. “The insertion sheath that comes with the valve is lubricious, making it easy to advance,” he says. “It’s also more stable in the aortic valve as it’s being delivered, and the markers that allow us to position it correctly are easily visible. Unlike the Evolut, which is the competing self-expanding valve, the Navitor valve sits lower down in the cage of the prothesis. That means it’s less likely to obstruct our future access to the patient’s coronary arteries. Lastly, instead of sitting in the aortic valve as if at the narrowest point of an hourglass, which is the case with the Evolut, the Navitor deploys as a straight tube, which means the size of the valve may be larger. All in all, the Navitor valve gives us an easier and more stable deployment mechanism, a lower valve, and may provide for a larger valve area.”
Changing Lives with Individualized Care
The Structural Heart Disease team performed their first TAVR procedure using the Navitor valve in October of 2024 with excellent results, and has carried out several other successful procedures since.
“I think being the first in the region to use the Navitor valve commercially, with such great results, really sets us apart from the other programs in the Philadelphia area,” Pietrolungo says. “A lot of programs will just use one valve on every patient, regardless of their anatomy. But every patient is different, and having three valves to choose between gives you the best opportunity to align the procedure with their individual characteristics.”
She also believes that, thanks to the Navitor valve, her team will be able to make the TAVR procedure even more inclusive. “Whereas in the past, we may have had to tell patients that they weren’t candidates for TAVR because they were too high-risk, the Navitor valve will change that,” Pietrolungo explains. “We can help even more patients dramatically improve their quality of life.”
