Features November 2016 Issue

New TAVR Valves Available to More Patients, Safer Than Earlier Models

The FDA approves transcatheter aortic valve replacement to treat patients who are of intermediate risk from surgery. TAVR had been limited to high-risk, inoperable patients.

When aortic valve stenosis gets to the point where a replacement valve is necessary, patients usually must undergo open heart surgery to receive a new valve. It’s an invasive procedure that comes with a long recovery and the potential complications associated with any surgery.

Several years ago, a new option emerged for people too frail or sick for surgery, or who were considered “high risk” for open-heart surgery. It is called transcatheter aortic valve replacement (TAVR), and it eliminates the need for open surgery. Instead, the doctor inserts a catheter into a blood vessel in the leg and then guides it up to the aortic valve in the heart. There, the prosthetic valve is opened and set in place.

Recently, though, TAVR was approved by the U.S. Food and Drug Administration (FDA) for use in patients of “intermediate risk.” Cleveland Clinic heart surgeon and valve specialist Stephanie Mick, MD, says the expanded use of TAVR is an exciting development. She adds, however, that the age of the patient and other factors are still key considerations in deciding whether TAVR is the right choice for patients with aortic valve disease.

“Practitioners still have to be a bit cautious about putting TAVR valves in younger patients—those in their 60s or even 70s,” she explains. “We don’t know the long-term durability of these valves. They may last 10 to 15 years, but we just don’t have the data yet. We really won’t know that for five to 10 years.”

TAVR Criteria

Even though TAVR is approved for use in a wider pool of patients, the decision to use this procedure remains a complex one. It’s also a choice that is made by a team, Dr. Mick explains. A patient’s history and condition are evaluated by a multidisciplinary team that includes the patient’s cardiologist, a cardiac surgeon, and an interventional cardiologist. “The patient’s other risk factors have to be evaluated,” Dr. Mick says. “It’s definitely a group decision.”

A patient deemed inoperable still may not be a good TAVR candidate, unfortunately. Arteries that are too small to accommodate a catheter safely, for example, may eliminate TAVR as an option. Dr. Mick notes, however, that recently approved TAVR valves are smaller than earlier generations of the device, meaning more patients may be good candidates. And even if TAVR appears to be a safe choice, open surgery may still be necessary. If a patient needs bypass surgery to treat a narrowed coronary artery, for example, open surgery to treat the artery and aortic valve in once procedure makes sense.

Understand Aortic Valve Stenosis

The aortic valve opens to let blood flow from the heart to the aorta, your largest artery and the one that sends blood to most of the body. Over time, the aortic valve can narrow and stiffen, restricting the amount of blood that flow into the aorta. This condition, called aortic stenosis, can be the result of a congenital heart defect called bicuspid aortic valve. Usually the aortic valve has three leaflets or flaps that open and close to control blood flow. A bicuspid valve has only two leaflets and is at higher risk for problems later in life.

Most cases of aortic stenosis develop when calcium collects around the valve. The valve can also become scarred from rheumatic fever.

TAVR transcatheter aortic valve replacement

With TAVR, a tiny balloon and collapsed prosthetic valve at the end of a catheter are guided to the aortic valve (far left) and inflated (center). The catheter is then removed and the new valve is left in place.

TAVR Risks Lessening

One of the biggest concerns with TAVR was that its risk of contributing to a stroke was higher than the stroke risk associated with open surgery.

Dr. Mick says that with improved technology and growing physician experience with TAVR, the stroke risks are about the same between the two procedures. The risk of requiring a pacemaker after TAVR is higher than it is with open-heart surgery, but the risks with TAVR have been dropping in recent years.

Benefits of TAVR

If TAVR is approved to treat your aortic valve stenosis, you can look forward to a less-invasive procedure with a much shorter recovery time, compared with open surgery. With TAVR, for example, there is no need for a heart-lung machine. Patients may undergo general anesthesia or twilight anesthesia.

After a TAVR procedure, patients usually stay in the hospital two or three days and can resume most normal activities within a week. With open-heart surgery, the hospital stay is often around a week, and recovery can last a few months. Precautions, such as not lifting heavy objects for a few months, are part of any open-heart surgery patient’s recovery period.

“After three months, the quality of life is about the same for TAVR and surgery patients,” Dr. Mick says. “But for someone who is 85 years old, recuperating for three months is a significant part of their life.”

She adds that for many patients, receiving a new aortic valve through TAVR or surgery is life-changing.

“They’re usually short of breath, very tired, and there may be fainting,” Dr. Mick says. “Once the valve is replaced, those symptoms go away. They go back to their normal life again.”

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