[Originally published: July 22, 2020. Updated: Dec. 14, 2023.]
TAVR, or transcatheter aortic valve replacement, is a potentially lifesaving procedure used to treat a heart condition called aortic stenosis—a narrowing of the aortic valve. The development of significant aortic stenosis becomes more common as people age and can increase strain on the heart, eventually leading to heart failure.
For patients undergoing TAVR, a catheter is placed through a blood vessel in the leg—through this catheter, a new valve is delivered to the heart, replacing the failing aortic valve. Patients undergoing the procedure require minimal sedation, are up and walking the same day of the procedure, and usually go home the next day. That’s very different from open-heart surgery, long considered the “gold standard” treatment for aortic stenosis.
“Yale performed the first TAVR in Connecticut in July of 2011,” says Yale Medicine cardiologist John K. Forrest, MD. At that time, TAVR was limited to patients considered high risk for open-heart surgery. Given the benefits of TAVR, including a faster recovery and quicker improvement in quality of life compared to surgery, there was an incentive to evaluate this technology in lower-risk patients. In 2019, due in part to studies led by Yale physicians, TAVR approval was expanded by the Food and Drug Administration (FDA) to include all patients with severe aortic stenosis regardless of their surgical risk.
“In the last few years, the number of aortic valve procedures done with a transcatheter approach has surpassed the number done with open-heart surgery," says Dr. Forrest, director of the Structural Heart and Valve Disease Program and the Interventional Cardiology Program at Yale.
As of November 2023, more than 2,500 patients have had TAVR in the Yale New Haven Health System hospitals in New Haven and Bridgeport, Connecticut. There are plans for Yale physicians to provide the procedure at the Veterans Affairs (VA) Connecticut Healthcare System in West Haven, making it one of the first VA hospitals in the Northeast to provide TAVR.
Many patients still undergo open-heart surgery, also called surgical aortic valve replacement (SAVR), often because their valve isn’t anatomically suited to TAVR, and surgery remains an excellent option for some patients, Dr. Forrest adds. In fact, having two different treatment choices has led to a new approach to aortic stenosis in which a collaborative team of cardiac specialists helps each patient determine the best approach for them.
Below, Dr. Forrest and Yale Medicine interventional cardiologist Amit Vora, MD, MPH, answered common patient questions about TAVR.
1. What is aortic stenosis, and who is affected by it?
The heart has four valves that control blood flow. The valves have leaflets (like flaps) that open and close to allow blood to flow through them. Aortic stenosis is a narrowing and stiffening of the valve between the heart’s main pumping chamber (the left ventricle) and the body’s main artery (the aorta). It’s a progressive condition that makes the heart work harder, eventually causing such symptoms as shortness of breath and, in severe cases, restricting and blocking blood flow from the heart and aorta to the body.
Someone with aortic stenosis may also notice symptoms such as fatigue, lightheadedness, swelling in the legs, or chest pain—or they may have no symptoms at all. But a doctor listening to their heart through a stethoscope will hear a swishing sound known as a heart murmur, which could be a sign that the stenosis is significant.
The aortic valve is the most common valve requiring replacement among people older than 65, when calcium deposits are more likely to build up on the heart valves.
“Severe aortic stenosis is a life-limiting condition—median survival is only about two years,” says Dr. Vora. “That means only about half of those patients are still alive after two years. In that time, heart failure can also occur, requiring multiple trips to the hospital.”
2. What is TAVR, and how is it performed?
TAVR is a minimally invasive way to fix an aortic valve that isn’t working properly. Under X-ray guidance, a sheath (a hollow tube) is inserted through an artery in the groin (or sometimes in another location). Through this sheath, a new heart valve can be advanced up to the appropriate location in the heart. Once it is in position, the new valve is deployed, pushing the old stenotic valve to the side, allowing the heart to effectively pump out blood through a new and normally functioning aortic valve.
A TAVR procedure usually takes about an hour. The patient is sedated but awake. “Because the procedure can be done in a minimally invasive fashion, patients are up walking the same day of their procedure and usually go home the following day,” Dr. Forrest says.
3. How do you know if you’re a candidate for TAVR?
This decision should be made with the help of a team of cardiac specialists that could include a cardiothoracic surgeon, an interventional cardiologist, the patient’s primary cardiologist, and imaging specialists, Dr. Forrest says.
“It takes a team approach to understand the intricacies of the different procedures and nuances of individual patient anatomy, so we sit down as a group and discuss each patient in detail to come to a decision on the best approach. We’ll say, ‘This is what we think, based on this patient. Let's talk to them, understand their preferences, and create an individualized plan,’” he says.
There are tools to help with the decision. “We use computer programs and virtual modeling tools to create 3D models for each of these patients to help determine what will be suitable for their specific anatomy,” he says.
Though not without some risks, TAVR is often the first choice for many patients—“certainly, it’s the best approach the majority of the time in patients over 75,” Dr. Forrest says. Often, these patients have other conditions, and many have congestive heart failure.
“What is most exciting is that recent studies have shown that TAVR is also a promising treatment choice for anyone over the age of 65 who has suitable anatomy,” adds Dr. Forrest. Patient preference is also taken into account. “At one time, ‘low risk’ was defined by the surgical risk of surviving the procedure,” Dr. Forrest says. “We're now taking a look at the patient as a whole and asking, ‘What are our goals for you and your quality of life moving forward?’”
4. What is recovery like from TAVR?
On average, patients spend a night in the hospital and go home the next day—and usually do not need time in a rehabilitation facility, explains Dr. Forrest. “You are back on your feet faster compared to an open surgery. There aren't restrictions on things like how quickly you have to go back to driving or when you can pick up your grandkids; those are restrictions you would have for several months after open-heart surgery.” Patients continue regular follow-up visits to monitor the valve over time.
By comparison, open surgery for aortic stenosis involves an incision along the breastbone and the use of a heart-lung machine to take over the function of the heart during the operation. Recovery requires around a week in the hospital, and it takes several months before patients fully recover.
“If they just need the valve replaced, most patients take baby aspirin afterward. Historically, people were on aspirin and Plavix® [a blood-thinning medicine], but more recently the guidance is just baby aspirin,” says Dr. Vora.
5. How successful is TAVR?
Two landmark TAVR studies published in The New England Journal of Medicine (NEJM) in March 2019 found that disabling strokes and rehospitalizations, which can include complications of treatment, were at least slightly lower with TAVR than with open-heart surgery. The average age of participants in the studies was in the low 70s. Dr. Forrest was a principal investigator in one of the two NEJM studies.
6. What if you are not a candidate for TAVR?
Many people still undergo open surgery, in some cases because their individual anatomy or a problem, such as an infection of the original valve, may make TAVR too risky. Surgery also makes sense when a patient has other issues, such as critical blockages in the heart arteries, that can be treated at the same time, Dr. Vora explains.
“This is a surgery that has been developed and refined for more than 50 years, and the outcomes, especially in low- and moderate-risk patients, tend to be excellent,” says Dr. Vora.
For patients in their 60s or younger, a key concern is that they may need another valve replacement procedure in 10 or 15 years, roughly the lifespan of a replacement valve. A potential issue is that a second TAVR procedure involves inserting another new valve into the TAVR valve, which can have added risks, depending on the patient’s anatomy, Dr. Forrest says.
“Often, what we can do is plan for the second procedure before we decide what the first one should be,” Dr. Vora says.
7. What are the concerns around TAVR?
One risk in treating aortic stenosis is that some patients will need a pacemaker—the risk is similar with both SAVR and TAVR but slightly higher with TAVR. “The main reason for this is that the electrical wiring of the heart runs underneath where the aortic valve sits,” says Dr. Vora. “So, there is a chance that during a procedure, the wiring can be injured, and that can sometimes lead to the need for a pacemaker.”
Dr. Vora says refinements to TAVR in the past five years have decreased pacemaker implantation rates from as much as 25% five years ago to less than 10% at most centers across the country.
Meanwhile, Alexandra Lansky, MD, a Yale Medicine cardiologist, has studied catheter-based procedures for the past decade and has done extensive research on stroke prevention in TAVR patients. While the risk of stroke is lower with TAVR than with surgery, it still affects 2% to 3% of TAVR patients, Dr. Lansky says. She is currently evaluating several new devices used during the TAVR procedure that are designed to shield and protect the brain from plaque, calcium, or debris (such as pieces of the calcified heart valve) released during the procedure, which is known to be an underlying cause of stroke.
Dr. Vora, who has worked with Dr. Lansky on stroke prevention, adds that while the risk is low, stroke can be devastating, and devices or technologies that can reduce the risk any further or predict who will develop stroke will help.
8. Is TAVR still evolving?
Experts are still studying and refining TAVR procedures. Dr. Forrest was the national lead investigator for a study that included four years of follow up. It showed that TAVR, using the Medtronic Evolut Transcatheter Aortic Valve, had valve performance and clinical outcomes comparable to SAVR. Results were published in the Journal of the American College of Cardiology.
“We've known that there are benefits to having a transcatheter procedure because it’s less invasive and there's easier recovery compared to open surgery,” Dr. Forrest says. “But there were questions about the long-term durability of valves. And now, for the first time, we were able to show that, after four years, patients are still doing better after TAVR than they are after open-heart surgery.”
“It’s been a steady push forward,” Dr. Forrest says. “With each new finding, we continue to see that TAVR may be a viable option for an increasing number of patients.”