New FDA Heart Valve Replacement Approval Offers More Hope to Many

When new, advanced treatments for heart disease become available to more people, lives can be saved, quality of life enhanced, and longevity of life extended.

It’s with caution, however, that we can assume these medical miracles are beneficial for everyone.

So is the case with the latest changes in Federal Drug Administration (FDA) approval, which expands indications for the TAVR procedure to treat aortic stenosis with a complex, minimally invasive aortic valve replacement technique.

We spoke to Kevin Accola, MD, cardiovascular surgeon at the AdventHealth Cardiovascular Institute, coincidently, right after he performed a TAVR procedure, to learn about what this latest FDA approval for TAVR could mean for you or a loved one facing aortic stenosis.

Aortic Stenosis Explained

Aortic stenosis has been named the most common disease of the heart valves that leads to treatment.

“Aortic stenosis is a progressive disease that affects the aortic valve, which is the main artery going out of the heart to the rest of the body,” explains Dr. Accola.

“As we age, we can get calcification in the aortic valve, which may progress to a stenotic state. This means that it doesn’t open up to an adequate orifice [opening] to let out the optimal amount of blood to the body.”

Dr. Accola adds that as a result, the heart has to work harder and harder to compensate for the restricted blood flow.

Aortic stenosis is progressive, meaning it occurs and worsens over years. That said, it is rarely an emergent problem.

Symptoms can be subtle, and because it is more common with older age, many people chalk their symptoms up to the normal aging process.

Some of these symptoms include:

• Shortness of breath during even little activity
• Dizzy spells (feeling like you’re going to faint or pass out)
• Chest pain

“If you have any of these symptoms, it’s important to discuss them with your primary care doctor who can perform a few in-office evaluations. If your doctor hears a heart murmur through a stethoscope, they may order an echocardiogram [an ultrasound of the heart], which can determine if there’s a gradient across aortic valve, or if it’s not moving properly or affected by calcium. In those circumstances, patients are referred to a cardiologist for more extensive evaluation.”

While aortic stenosis most commonly affects people during their later stages of life, some younger patients with a bicuspid aortic valve anomaly have a higher risk of aortic stenosis at a younger age (typically between age 40 and 60). People with a bicuspid aortic valve are generally aware of this heart defect, so their aortic valves are usually monitored regularly.

TAVR to Treat Aortic Stenosis

Treatment for more severe aortic stenosis often leads to an aortic valve replacement. Years ago, this procedure was only performed with open-heart surgery.

Today, however, advancements in medical devices and surgical techniques have introduced new minimally invasive options, including TAVR, which stands for transcatheter aortic valve replacement, or TAVI (transcatheter aortic valve implantation).

Performed minimally invasively through a catheter that typically enters through the groin and into the femoral artery, cardiovascular surgeons like Dr. Accola place the replacement valve on a wire that is led to the heart. Through a series of complex steps, the stenotic aortic valve is pushed aside, and the replacement valve is fit into its place.

“Once the replacement valve is in position and we stop rapidly pacing the heart, the new valve begins working immediately. It’s incredible to witness,” says Dr. Accola.

He adds, “We established our TAVR program in 2012, and over time, the team has become very experienced in these procedures and in understanding what patients will have the most optimal outcomes. Our team includes five interventional cardiologists and two cardiovascular surgeons who meet once a week to review each case and decide if the patient is a good candidate for TAVR or open-heart surgery.”

New FDA Approval of TAVR in Low-Risk Patients

The original TAVR trial led to approval in patients who were otherwise considered inoperable, or at a high-risk of death or serious complications from open-heart surgery. As the trial quickly progressed, patients of intermediate risk (those not considered low risk but not high risk) were indicated for TAVR as well.

“One important aspect of TAVR is that we went from transapical (an incision in chest) to transfemoral (an incision in the groin). This made the procedure safer because we don’t have to open the chest cavity. We also rarely need to put patients under general anesthesia. Today, the exponential growth in technology and our experience has made TAVR safer and more accessible to specific patient populations.”

In August of 2019, further trials led the FDA to approve TAVR for patients at a low-risk of complications or death from open heart surgery.

You might think that this means TAVR is for everyone, but Dr. Accola advises being cautious about this conclusion.

“The perception of “low risk” can be misleading because TAVR might not be optimal for everyone, including younger patients, or those with specific anatomical deviations and disease states. We’re still perfecting TAVR. The data we have today shows that its outcomes are comparable to open-heart surgery, but we don’t have longitudinal studies proving the safety and longevity of the TAVR valves.”

“For younger, active patients who may have a longer life expectancy after the procedure, there could be more discussion around the pros and cons,” Dr. Accola states. “But TAVR can be a superior choice for the right patient because it is less invasive, requires a smaller incision, less anesthesia and a shorter recovery time compared to open-heart surgery.”

For older patients that have other conditions that would prohibit open heart surgery, TAVR can be a treatment option that helps them get back to their activities. Patients often return home after a two-day hospital stay, and within a week they are usually back to their normal lives.

Now, with expanded FDA approvals TAVR to low-risk populations, the option for TAVR (as well as insurance coverage) is expanded to more people.

Dr. Accola concludes, “After 27 years in practice, it’s an exciting time to be involved in this field and see the momentum on the horizon. We’re advancing by leaps and bounds, but the safety of our patients is always first. We can offer treatment options to more people with TAVR, but it’s a personalized approach. Our cardiologists and surgeons sit down with each patient and discuss the best options for them as an individual.”

We’re here to care for your heart, in body, mind and spirit. Learn more about AdventHealth Cardiovascular Institute’s established TAVR program to treat heart valve disease.