While the 5-year results of the PARTNER 3 Low-Risk trial and the 4-year results from the Evolut Low-Risk trial both showed excellent results for TAVR, Grubb said the real test will be the data from these trials at the 10-year mark. Surgical valves were believed to have superior durability, but the TAVR data presented at TCT 2023 showed this may not be the case

“What we have now is at least five- and four-year data. That’s reassuring. It doesn’t answer the question what’s best yet, but it gives us an idea that what we’re doing today is appropriate. We’re having informed discussions with our patients about what their choices are when they come to us with severe symptomatic aortic stenosis,” Grubb explained.

After taking a deep dive into the PARTNER 3 Low-Risk trial data published in the New England Journal of Medicine, she said there are concerns that the curves for death cross at about two to three years, but she noted it is not statistically significant.[1] 

The Evolut Low-Risk trial data curves do not cross, Grubb said. That trial also shows consistently good hemodynamics and outcomes as good as or better than surgery.

Long-term management of younger patients who need aortic valve replacement

Minimally invasive TAVR has prompted many more patients with aortic stenosis to come forward to seek treatment or get referrals to structural heart programs. Some of these patients did not want to undergo open heart surgery, or their doctors did not feel they will be good candidates. This has resulted in the discovery of a much larger than previously thought population of treatable aortic stenosis patient. 

The growth in these patients can be seen in massive rise in TAVR cases being performed, but at many larger centers, SAVR rates have stayed about the same or actually increased.  

At the same time, the expansion of TAVR into younger and less sick patients has raised concerns among some cardiology experts. They suggest surgery might be the best solution for younger patients to save TAVR and possibly a second TAVR procedure for later in life when a patient becomes much more frail. 

The durability of surgical valves can range from several years to well over a decade, depending on the specific valve and patient factors. So, it is believed it is best to start off with open heart surgical valve replacement to cover the first 10-15 years and then consider TAVR procedures to cover another decade or so. However, TAVR trial evidence to data has not showing the expected valve failure rates, and in some cases have showed better durability than surgical valves. 

Grubb pointed to the recently presented NOTION trial at 10 years for the first generation of the CoreValve from 2009 presented at the European Society of Cardiology 2023 meeting in August. It showed all-cause mortality was the same between SAVR and TAVR, but structural valve deterioration was much more pronounced in the surgical valve arm of the trial. Moderate structural valve deterioration was 36% for SAVR and 19.4% for TAVR. Severe deterioration was seen in 11% of SAVR valves and only 3.1% for TAVR.

“I can tell my patients, well, it looks pretty good. Those valves didn’t fall apart at seven years like we’ve seen with some of the surgical valves,” Grubb said. 

Many questions related to TAVR vs. SAVR will be definitively answered in the next five years with the 10-year results from the low-risk TAVR trials. 

“When my patient comes to me and they want to know that they’re going to have a good outcome from the initial procedure, I can say that the choices are equivalent. And when they say, well, how long is this going to last? I’m 65. How many years? I don’t have the answer yet, but we’re getting there,” Grubb explained.

She said it is also essential to recognize that not all TAVR valves are the same. Each TAVR valve has its unique characteristics, and it’s crucial to consider these individual differences when assessing valve durability and long-term outcomes. She said the same is also true of surgical valves. 

New technologies are needed address the next implants in TAVR patients

She said almost a 100,000 TAVR and now performed each year just in the United States and this will require new technologies to be able to perform repeat TAVR procedures and more durable valves to enable a continuum of care for these patients without the need for surgery. The next generation of technology may include new tools to remove leaflets, the ability to still access the coronaries with overlapping devices and smaller profile frames to enable multiple valve-in-valve devices to be implanted. She said there is still hesitation to implant a TAVR today in younger patients because it is not known if these capabilities will be available in the next 8-10 years to address these issues in time for the patient’s next anticipated valve replacement. 

“There are lots of simulation models out there that are published and based on existing data. We can say approximately 70-80% of patients with an existing TAVR valve are going to be able to have a second valve. But are you going to have problems getting into the coronaries? Is the reality of being able to line up those two valves so that you can still access the coronaries are unknowns and all of our simulation is just that. It gives us an idea of what the future will look like, but we really won’t know until we’re actually treating patients,” Grubb said.

First transcatheter valve for aortic regurgitation captures attention at TCT

There was a large amount of buzz at TCT on the late-breaking results from the ALIGN-AR Pivotal Trial for the JenaValve Trilogy transcatheter heart valve system in high-risk patients with symptomatic, severe aortic regurgitation (AR). The three TAVR valves currently cleared by the FDA are designed to treat patients with aortic valve stenosis, where the calcified leaflets and annulus makes a hard, stable base to implant a valve. However, this is not the case in AR patients where use of the current TAVR valves could potentially result in embolization of the valve or oversizing the device to fit more securely can cause other issues. The Trilogy valve has nitinol clips built into its frame that capture the native valve leaflets to anchor the device. It is the first transcatheter device designed specifically for AR patients.

“I was very encouraged by JenaValve and their data for aortic regurgitation. We have nothing in this space. And so for those patients that are high risk or inoperable that really are not going to do well from a surgical standpoint, to have a tool that’s designed for them instead of using a device off-label. It is really exciting to finally have this tool available so we can help more patients,” Grubb said.

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