Who is a candidate for TAVR? The latest research

There are many advantages to the transcatheter aortic valve replacement (TAVR) procedure, especially when compared to the traditional method of open-heart surgery to replace the aortic valve. But TAVR is still relatively new, and like any new procedure or treatment, it’s important for the medical community to have as much information and data as possible before recommending it for widespread use.

Even if the procedure is successful on a large number of patients, there is still the question of durability – meaning it is important to know if the positive results will stand the test of time. Not all new medical technology proves to be a good option. As a patient, it can be tempting to request the latest or newest procedure if it seems to be better, but safety and long-term outcomes are the primary concern.

Fortunately for patients with aortic stenosis, the data on the TAVR procedure has been consistent over the course of many years, and the results of two studies that were recently released are being touted as a “game-changer” by doctors. The studies point toward TAVR being a viable option for a wider population of patients beyond those who were initially considered candidates.

Initial usage of TAVR

TAVR was originally performed in 2002 after being first trialed in animals. Traditionally doctors would perform open-heart surgery (sometimes called SAVR, or surgical aortic valve replacement) if they needed to replace a patient’s aortic valve. But investigators discovered the valve could be replaced percutaneously, and the first balloon-expandable transcatheter heart valve was developed.  This method was less invasive than opening up the chest, but there were still concerns about the complications and long-term viability of the procedure.

Because SAVR had already been proven to be a safe way to replace the valve, TAVR, which was “experimental” in the early stages, was primarily used on very old, sick patients who would not be able to survive without intervention and were not eligible for SAVR. Essentially TAVR was the last resort.

But as time passed and more successful TAVR procedures were performed, younger and lower risk patients were studied to determine if the procedure was safe for a wider population. Significant progress was made in the last few years and most recently, two studies in particular prove at the very least that TAVR is equivalent to surgery in the treatment of low-risk patients with aortic stenosis, according to a TCTMD article.

What the latest research shows

The studies enrolled more than 2,400 patients who were considered low risk, meaning they were younger, and their symptoms were not as severe. Approximately half of the patients were given SAVR, and the other half were given TAVR. In both studies, the rate of death and disabling stroke was lower in the TAVR group than the SAVR group. This data was considered the main measurement or “primary endpoint” of the studies.

Many cardiologists agree that the results confirmed TAVR should be more widely used (via New York Times):

  • “The results ‘shift our thinking from asking who should get TAVR to why should anyone get surgery,’ said Dr. Howard Herrmann, director of interventional cardiology at the University of Pennsylvania.”
  • “’If I were a patient, I would choose TAVR,’ said Dr. Gilbert Tang, a heart surgeon at the Icahn School of Medicine at Mount Sinai in New York, who was not involved in the new research.”
  • “’Is it important? Heck, yes,’ said Dr. Robert Lederman, who directs the interventional cardiology research program at the National Heart, Lung and Blood Institute. The findings “were remarkable,” he added.”

According to the New York Times, The Food and Drug Administration is expected to approve the procedure for lower-risk patients. As many as 20,000 patients a year would be eligible for TAVR, in addition to the nearly 60,000 a year intermediate- and high-risk patients who get the operation now.

Other Factors to Consider

It is important to note that although TAVR has many advantages over SAVR, there is still a risk of stroke that is associated with TAVR. During the procedure, embolic debris (also known as plaque – a buildup of fat, cholesterol, calcium, and other substances found in the blood) can get knocked loose. This is important because those small particles of embolic debris could travel through the bloodstream to the smaller arteries in the brain and block them. Blocked blood flow in the brain has the potential to cause a stroke, which could result in brain damage and could be fatal.

Fortunately, there are ways to help prevent complications from embolic debris. The U.S. Food and Drug Administration (FDA) has cleared what is called a cerebral embolic protection device for use during TAVR procedures. The Sentinel® Cerebral Protection System is the first and only one of these devices approved for use in the United States to reduce the risk of stroke during TAVR. The Sentinel filters your blood, capturing and removing embolic debris that may be released during such procedures. Sentinel technology has been used to protect thousands of patients worldwide. In clinical studies, the Sentinel removed potentially dangerous embolic debris in 99% of patients undergoing TAVR.

Wondering if you or your loved one might be a candidate for TAVR? The best thing to do is talk with your Heart Team and ask questions. A great place to start is our resource, Questions to Ask your Doctor. It’s free to download and can help start the conversation to see if TAVR and Sentinel might be right for you. You can also get a first person perspective from patients who have had the procedure here.

References:

Accessed March 10, 2019.

Accessed March. 20, 2019.

This educational blog was provided by Boston Scientific.