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FDA Approves Transcatheter Aortic Valve Replacement for Low Risk Patients At St. Clair Hospital Cardiovascular Specialists Perform TAVR Procedure
By Nancy Kennedy


There is excellent news for persons who are struggling with severe aortic stenosis, a serious condition of the heart valves. The FDA has recently expanded patient eligibility for trancatheter aortic valve replacement, or TAVR, a groundbreaking valve replacement procedure that was previously reserved only for patients who were too frail, ill or elderly to undergo the open-heart surgery that has been the standard, proven treatment. TAVR is a less-invasive surgery and a far less stressful experience for the patient, according to two expert cardiovascular specialists who have been performing the TAVR procedure at St. Clair Hospital for the past year. Andy C. Kiser, MD, FACS, FACC, chief of cardiac surgery at St. Clair, and Ryan W. Zuzek, M.D., a board certified interventional cardiologist and the director of the Hospital’s cardiac cath lab, perform the TAVR procedure jointly at the Hospital, supported by a multidisciplinary Heart Team of dedicated imaging cardiologists, anesthesiologists, OR technicians, and others.

“Before the FDA approved TAVR for low-risk patients, it was reserved for those who were considered too high risk for open heart surgery. Younger, healthier patients at low risk were considered better able to tolerate surgery and recover well, and so they didn’t qualify for TAVR,” explains Dr. Zuzek. “They had to have open chest surgery. Now, they have options. The patient can have a risks/benefits discussion with the physicians about the most appropriate treatment for their individual needs and goals. This new FDA approval is based on a trial with 1400 valve replacement patients; the trial demonstrated that the replacement valves are safe and effective.”

The heart’s four valves are leaflet-like tissue flaps that function like gates between the heart’s chambers. They open and close to regulate the flow of blood and assure that blood is flowing one-way. When they become diseased, it is most often a consequence of calcium build-up on the leaflets that narrows the passage through the valve; this narrowing is known as stenosis. Eventually, the leaflets become stiff and this compromises their ability to perform their job of opening and closing, and the heart has to pump harder to propel blood through the thickened valves. Aortic stenosis specifically means that the passage between the hearts’ left ventricle and the aorta, the large, main conduit from the heart to the body, has narrowed. Symptoms of aortic stenosis may include shortness of breath, irregular heartbeat, swelling of the legs and feet, chest pain, fatigue and dizziness.

Although Dr. Kiser performs minimally-invasive aortic valve operations, open heart surgery for aortic valve replacement usually requires a large chest incision, through the sternum, and the use of a heart-lung machine to temporarily assume the function of the heart. It’s a major surgical procedure and requires intensive post-operative care. TAVR, as a catheter-based technique, is a significantly less invasive procedure. At St. Clair, Dr. Kiser and Dr. Zuzek perform the TAVR procedure side-by-side; they make a small incision in the femoral area of the leg, and using x-ray and echocardiography imaging, direct the passage of the new valve through the body. It is delivered to the heart on a balloon system that, when inflated, pushes aside the diseased valve leaflets. Once the new valve is secure, the surgeons test it to make sure it is working exactly as it should.

TAVR has many advantages for the patient:

  • Less time in the OR under anesthesia
  • No chest incision
  • Much shorter length of hospital stay
  • Less blood loss
  • Less discomfort
  • Faster recovery: two weeks versus two months

As with any surgery, valve replacement surgery carries certain risks. The most serious risks of TAVR include stroke; vascular complications such as blood clot; heart attack, and heart failure.

“People with aortic valve disease who were sick but reluctant to undergo open heart surgery in the past now have the opportunity to have the TAVR procedure, to restore their health and get their lives back without the risk of surgery,” says Dr. Kiser. “We are doing the procedure at St. Clair and doing it very well; the patients are doing great. We have a comprehensive Valve Program at St. Clair and can do everything from a complex valve reconstruction to TAVR. With the FDA’s announcement, TAVR is now an option for anyone with severe aortic stenosis.”

For more information about the TAVR procedure, call (412) 942-5728.



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