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Over the last few years, data have accumulated that untreated aortic valve disease, particularly in elderly people, is a problem despite the success of surgery and newer methods of treatment.1–32
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The history of percutaneous treatment of aortic valve disease with various types of device goes back to the work of Danish researcher, H.R. Andersen, who in the late 1980s experimented in an animal lab with a balloon-expandable stented valve.15 The technology was later acquired by PVT Company and further developed and later sold to Edwards. The early work was done by Alain Cribier21,22 and subsequently the expandable stented valve was adopted in the United States and further modified. The initial approach taken by Cribier was to insert the valve via the femoral vein and then using a transeptal technique to snake the catheter through the mitral valve and left ventricle to access the aortic annulus. This turned out to be a fairly cumbersome and difficult operation to do with a fairly high mortality rate and an 8.1% stroke rate. At the same time, animal experiments were carried out by Michael Mack, Todd Dewey, and Lars Svensson,17,25 to use a transapical approach to insert the aortic valve. During this time period, John Webb and colleagues18,19 were also developing a transapical aortic valve method, and subsequently they introduced the retrograde transfemoral artery approach. This latter technique became feasible once Edwards developed a catheter that could be flexed to get around the aortic arch to access the aortic valve.
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The Revival Trial was started in the United States in 55 patients using the retrograde transarterial transfemoral approach (Transapical aortic valve insert, TFAVI; Figs. 39-1, 39-2, and 39-3).24 A separate Revival trial also included a transapical approach in 40 patients.25 In the United States, the three centers involved in these studies were Cleveland Clinic in Ohio, Columbia in New York, and Medical City in Dallas. In the first transfemoral Revival series of patients, the mortality rate was 7% and the stroke rate 9.2%. The transapical (TA-AVI) (Figs. 39-4, 39-5, and 39-6) had a higher mortality rate of 17% in the first 40 patients with no immediate strokes after successful insertion, although two patients did develop strokes, one after an open replacement for aortic valve disease in a very heavily calcified ascending aorta and the other in a patient who developed atrial fibrillation a few days after surgery. Based on the feasibility studies, the FDA then approved a prospective randomized trial to further evaluate the device technology.
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