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TAVR – Recent outcomes prove beneficial for low-risk patients

Transcatheter Aortic Valve Replacement (TAVR) was a hot topic at the recently held American College of Cardiology annual meeting in New Orleans, LA. There were several presentations revealing the results of two large clinical trials that enrolled 1,000 patients each. The outcomes from a clinical trial named Partner 3, compared TAVR to traditional open surgical replacement for low risk patients with aortic stenosis (AS). Baylor Scott & White Health was the top enroller in this national study and helped contribute to the overall findings which indicated that TAVR continues to live up to its expectation of revolutionizing treatment options for cardiovascular patients with aortic valve stenosis. TAVR was shown to be safer and more effective than surgery in treating patients with AS.

Physicians on the medical staff at Baylor Scott & White Heart and Vascular Hospital - Dallas have been pioneers in TAVR and the use of various types of valves through clinical trials. Because of the high volume of procedures performed annually, the hospital, through its Center for Valve Disorders, is recognized as one of the leading TAVR centers in the United States. In fact, the hospital will soon celebrate a milestone, its 1,000th TAVR procedure.

Aortic valve stenosis is a thickening or stiffening of the leaflets of the valve that usually allows pumps oxygen-rich blood to flow into the aorta, the largest blood vessel in the body. Stenosis means the valve opening is limited and can be caused by calcium build up in the valve, a genetic defect, or Rheumatic fever. If the valve is not functioning properly, the heart works harder to supply enough oxygenated blood to the body and can fail.

A minimally invasive technique, TAVR places a new valve inside the diseased valve using a catheter that is inserted into an artery in the groin and guided by an interventional cardiologist or heart surgeon into the diseased heart valve. The procedure eliminates traditional valve replacement surgery that involves opening the patient’s chest to cut out the diseased portion of the valve and replace it with a new valve. TAVR patients experience shorter stays in the hospital, reduced recovery times, and less pain. In fact, at Baylor Scott & White Heart and Vascular Hospital – Dallas, the average length of stay for TAVR patients is less than two days.

When it was first introduced in the early 2000’s, TAVR was seen as a procedure of last resort for older patients who were too sick to undergo open-heart surgery. These patients were considered “high-risk” for cardiac surgery. Over time, clinical trials have been done to understand the safety of TAVR for not only high-risk patients, but also moderate risk. The two most recent large clinical trials showed the procedure to be safe and effective for patients deemed as “low-risk.”

One clinical study tracked deaths, disabling strokes and hospitalizations at one year following the procedures. Traditional open-heart surgery had a rate of 15 percent while the rate with TAVR was 8.5 percent. The rates of disabling strokes and deaths were 2.9 percent with surgery versus 1 percent with TAVR. The second study evaluated deaths or disabling strokes at two years. Rates were 6.7 percent with surgery versus 5.3 percent with TAVR.

While TAVR is not appropriate for all patients requiring a valve replacement, the Food and Drug Administration will take this recent data into consideration as it examines possible approval of the procedure for lower-risk patients in the near future. If approved, an additional 20,000 people would be eligible TAVR patients annually plus the approximately 60,000 intermediate and high-risk patients who are candidates for TAVR now.

The multi-disciplinary team at the Center for Valve Disorders, comprised of interventional cardiologists and cardiac surgeons on the medical staff, imaging specialists, and nurse practitioners, is encouraged about the positive outcomes patients are experiencing from TAVR. The team is committed to continuing its groundbreaking work in research and clinical trials. Patients who present to us with a diseased or damaged heart valve, will continue to be evaluated as to the appropriate course of treatment.

For more information about the Center for Valve Disorders, please call 214.820.3604. For additional information on Aortic Stenosis, check out a recent Scrubbing In blog post.

By Robert Stoler, MD, FACC, FSCAI
Co-Medical Director of Cardiology and Medical Director of Catheterization Laboratory
Baylor Scott & White Heart and Vascular Hospital — Dallas
Clinical Professor of Medicine
Texas A & M Health Science Center College of Medicine