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

by Lowell F. Satler, MD, Medical Director, Cardiac Cath Lab
March 23, 2017

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.

Category: Innovations     Tags: advanced heart failureaortic-stenosisaortic-valveaortic-valve-replacementheart-transplantmhvitavr