TAVR is used for high-risk aortic stenosis patients. Why not everyone?

As recently as 15 years ago, if you had severe aortic stenosis but were considered too ill or weak to survive surgery, there was little else we could do for you. Since then, transcatheter aortic valve replacement (TAVR) has come on the scene as a less-invasive option to traditional open heart surgery.

This has been a game-changer for many people. Because it’s so new, not every facility offers this procedure. We have treated more than 1,300 patients with TAVR, and many of them travel here because they can’t get it closer to home or are interested in a less-invasive option.

TAVR currently is approved for patients with severe aortic stenosis who are at intermediate or high risk of complications during surgery, in addition to surgically inoperable patients. We have launched a clinical trial in 2016 to study the procedure’s safety and effectiveness in a wider range of patients. TAVR may become the new standard of care for more patients with this serious heart condition.

In the meantime, learn how TAVR works and whether you or a loved one might be a candidate for this procedure.

What is aortic valve stenosis and how is it treated?

Aortic stenosis occurs when the heart’s aortic valve doesn’t open fully, preventing blood from flowing freely into the rest of the body. This causes the heart to have to work harder and eventually weakens the heart muscle.

Aortic stenosis is a progressive disease, and as it worsens, symptoms may include:

  • Abnormal heartbeat (known as a heart murmur)
  • Chest pain
  • Dizziness or fainting
  • Fatigue
  • Shortness of breath
  • Sudden death

These symptoms can affect your daily life in many ways, from making it difficult to walk to the mailbox to adding stress from worrying about your health.

In the early stages of aortic stenosis, you may not need treatment. In that case, we’ll monitor the condition to ensure it’s not getting worse. Medications can ease symptoms, but will not fix the problem. The only way to do that is through surgery.

In a traditional aortic valve replacement, the surgeon makes a large incision in the chest, cracks the breastbone to reach the heart, removes the damaged valve and replaces it with a new one. This surgery typically requires a five-day hospital stay and four-week recovery.

TAVR doesn’t require a large chest incision or broken bones – making the recovery time much shorter.

How does TAVR work?

TAVR ProcedureIn transcatheter aortic valve replacement, the doctor inserts a catheter into an artery through a small incision in your groin or chest. At the end of the catheter is a deflated balloon with an artificial valve wrapped around it. The doctor guides the catheter through the artery to the aortic valve, at which point the balloon is inflated and the new valve expands, pushing the damaged valve out of the way. The doctor then deflates the balloon and removes the catheter.

This procedure typically requires a three- to five-day hospital stay. But because no bones need healing, most patients can resume normal activities soon after.

All surgical procedures carry risk. But a 2016 study showed that patients at intermediate risk for complications during surgery who received TAVR had slightly lower rates for death and stroke as those who had had a traditional aortic valve replacement. And for patients whose TAVR was done through the femoral artery in the groin, the rate was even lower.

Though TAVR is less invasive than traditional surgery, it’s not yet approved for all patients with severe aortic stenosis.

Who is a candidate for TAVR?

TAVR currently is approved by the Food and Drug Administration (FDA) for people with severe aortic stenosis who are at high or intermediate risk of complications during open heart surgery. These patients often are older or have other medical conditions that make surgery more dangerous.

Even then, not every patient who fits these criteria is a candidate for TAVR. You may have anatomical features or other conditions that may not make this procedure the best option. For example, if there’s significant disease in multiple arteries, you’d likely benefit from more than just valve replacement, in which case open surgery likely would be required.

One reason TAVR is currently restricted to patients at higher risk is that it’s a pretty new procedure, so we don’t have established data for how it compares over the long term to traditional surgery. One of the questions up in the air surrounds the durability of the valves used in TAVR. Valves used in a traditional surgical replacement last 10 to 15 years. We’ve only been performing TAVR for about a decade, so we don’t have long-term data on these devices yet.

For patients at high or intermediate risk during surgery, TAVR is quickly becoming the standard of care for severe aortic stenosis. The purpose of the latest studies is to determine whether TAVR is equal or superior to surgery for low-risk patients. Our trial will evaluate the safety and efficacy of the procedure in these patients.

TAVR is an exciting development in the treatment of aortic stenosis, and we’re hopeful that our study will help demonstrate that less-invasive procedures are safe and effective for as many patients as possible.

Safer, Faster, More Comfortable Cardiac Catheterization Gaining Ground

Since the 1970s, heart specialists have diagnosed and even treated certain conditions through cardiac catheterization—the process of threading a thin tube through an artery to reach the heart and its vessels. The technique gives cardiologists a close look at what’s going on inside, and even more importantly, the ability to intervene on the spot in cases of blocked, narrowed or weakened arteries.

In fact, cardiac catheterization is so common today that more than 1 million people in the United States undergo the procedure each year. And in nearly every case, cardiologists use the femoral artery, a large vessel deep in the groin, as the point of entry.

But not always.

Listen to the full podcast with Dr. Robert Lager.

The Current Landscape

“There’s been a push over the last five years or so to approach cardiac catheterization through the wrist, using the much smaller radial artery,” says Robert Lager, MD, an interventional cardiologist at MedStar Heart & Vascular Institute at MedStar Washington Hospital Center, and president of MedStar Cardiology Associates. “It poses less of a risk of bleeding—the major complication of traditional cardiac catheterization techniques—and it’s more comfortable for patients.”

That’s because recovery from the femoral approach requires patients to remain motionless on their back for four to eight hours to prevent significant post-procedure bleeding and other potential complications. For many, that inconvenience is a small price to pay for a potentially life-saving procedure. But for those with congestive heart failure, back or breathing problems, the protracted time lying flat can be miserable.

By contrast, recovery from the transradial approach is fast and easy.

“In theory, a patient could literally walk off the table after transradial catheterization,” says Dr. Lager, who uses the approach for approximately 80 percent of his cases. “In reality, we keep people in bed for an hour or so post-procedure to monitor for any problems from sedation. But they’re free to sit up, and even get a drink or eat soon afterward.” In addition, the time to discharge is shortened for those going home, and avoiding the groin allows patients to resume more strenuous activities like climbing stairs and aerobic activity earlier in their recovery, adds Dr. Lager.

Transradial cardiac catheterization has been the norm in many parts of Asia and Europe for decades. In the U.S., it currently only accounts for about 30 percent of procedures, in part because of the steep learning curve. However, that ratio is quickly changing.

“As more cardiology fellowship programs train new doctors to use the wrist instead of the groin for cardiac catheterization, we are getting closer to a tipping point of transradial becoming the default approach,” says Dr. Lager. “It’s already the preferred choice among younger cardiologists.”

Who Should Get Transradial Cardiac Catherization?

Not everyone is a good candidate for the transradial catheterization, however. Patients on dialysis may not be eligible, for example. And patients who have had bypass surgery can also pose more technical challenges, although Dr. Lager still uses the wrist for the vast majority of his bypass patients. In fact, national statistics report a 90 percent success rate for the transradial approach overall.

For those who are eligible, however, the advantages in comfort and convenience are compelling.

“Patients are already seeking out physicians who will do the transradial procedure,” concludes Dr. Lager. “As more people learn about its benefits, the demand is only going to increase.”

Catch the full podcast featuring Dr. Lager here.