TAVR Clinical Trial Provides ‘Strong Signal’ Procedure is Safe for Patients with Low Surgical Mortality Risk

Washington, D.C., September 5, 2018 – Results of a clinical trial using transcatheter aortic valve replacement provided a “strong signal” that it is safe for patients with low surgical risk, potentially helping to open the way for broader use of the minimally invasive procedure, also known as TAVR.

The Low-Risk TAVR trial results, presented at the European Society of Cardiology Congress in late August, showed no deaths or disabling strokes within 30 days of undergoing the procedure for 200 patients with low surgical risk who participated in the study, led by MedStar Heart & Vascular Institute at MedStar Washington Hospital Center.

The results of the trial–the firs-of-its-kind approved by the Food and Drug Administration–were published online in the Journal of the American College of Cardiology.

TAVR is currently approved by the FDA for patients with symptomatic severe aortic stenosis– an abnormal narrowing of the aortic valve in the heart–who are at extreme, high and intermediate risk for death from surgery. Surgical aortic valve replacement, or SAVR is the standard of care for the low-risk population, but the trial results indicate that TAVR in low-risk patients is a safe alternative, with lower complication rates from the procedure.

SAVR involves open heart surgery to replace the valve, while with TAVR, instead of opening the chest, physicians insert a new valve using a catheter threaded into the heart through a small incision in the groin or chest wall.

“The results of the Low-Risk TAVR trial are a strong signal that it is just a matter of time until TAVR is approved for general use with low-risk patients,” said Ron Waksman, MD, director, Cardiovascular Research and Advanced Education, MedStar Heart & Vascular Institute at MedStar Washington Hospital Center, and the study’s principal investigator.

The trial, conducted at 11 medical centers, compared results for the 200 TAVR patients with a control group of 719 patients who underwent SAVR at the same institutions. There were no deaths in the TAVR group at 30 days versus a 1.7 percent mortality rate in the SAVR group. Also, there were no in-hospital strokes in the TAVR group versus a 0.6% stroke rate in the SAVR group.

Dr. Waksman emphasized that the trial was sponsored by the participating investigators, heart teams and centers. The trial was managed by the academic clinical research organization at MedStar Heart & Vascular Institute.

“We are grateful to the FDA for trusting us to be the first to conduct a low-risk TAVR study in the U.S.,” Dr. Waksman said. “We are grateful to all the investigators across the U.S. who were willing to conduct the study at their own expense. They showed exceptional dedication and commitment.”

About MedStar Heart & Vascular Institute:
MedStar Heart & Vascular Institute is a national leader in the research, diagnosis and treatment of cardiovascular disease. A network of 10 hospitals and 150 cardiovascular physicians throughout Maryland, Northern Virginia and the Greater Washington, D.C., region, MedStar Heart also offers a clinical and research alliance with Cleveland Clinic Heart & Vascular Institute, the nation’s #1 heart program. Together, they have forged a relationship of shared expertise to enhance quality, improve safety and increase access to advanced services. MedStar Heart & Vascular Institute was founded at MedStar Washington Hospital Center, home to the Nancy and Harold Zirkin Heart & Vascular Hospital. Opened in July 2016, the hospital ushered in a new era of coordinated, centralized specialty care for patients with even the most complex heart and vascular diagnoses.

Media Contact

So Young Pak
[email protected]

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.