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History

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Before the development of cardiopulmonary bypass in the late 1950s, surgical attempts to correct valvular pathology were limited to closed valvotomy first performed on the aortic valve by Theodore Tuffier in 1912 and on the mitral valve by Elliot Cutler in 1923. In 1954, Charles Hufnagel designed the first mechanical valve, which he implanted in the descending aorta in patients with aortic insufficiency.1 The turning point in valvular surgery was the availability of cardiopulmonary bypass, which enabled surgeons to correct valve lesions under direct vision.2 Dwight Harken performed the first successful aortic valve replacement in the subcoronary position in 1960,3 and the same year Nina Braunwald implanted a ball and cage prosthesis designed in her laboratory in the mitral position.4 Working with Lowell Edwards, a retired engineer, Albert Starr, led the way from these isolated reports to an era of routine valve surgery by developing a ball valve to industrial quality standards and by solving the problem of how to secure the prosthesis to the recipient tissues.

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By 1968, more than 2000 Starr-Edwards ball and cage valves had been implanted,4 but the persistent risk of thrombotic and hemorrhagic complications was a major incentive underpinning efforts to establish a nonthrombogenic alternative. Homograft valves developed by Donald Ross5 after Carlos Duran's work were limited by problems of availability so that attention was directed toward pulmonary autograft by Ross6 and the use of porcine7 valves first implanted by Binet et al. Early failures with the porcine valve stimulated the use of alternative tissues, such as pericardium, fascia lata, and dura mater, which were used as substrates to manufacture valve prostheses. Despite attempts to increase longevity by fixation in formaldehyde, these valves showed signs of structural degeneration within a few years, and it was not until Alain Carpentier's breakthrough discovery in the mid 1960s of the ability of glutaraldehyde fixation to yield a much more durable valve, that tissue valves became a valuable alternative to mechanical valves.8 Carpentier used stent-mounted porcine valves to facilitate implantation and coined the term bioprosthesis to reflect the biological origin and the prosthetic nature of these valves.9 The term xenograft used in the past is scientifically inappropriate. A graft is made from a living or fresh or cryopreserved material. Its fate is based on the survival of the cells or on host cells ingrowth. A bioprosthesis is made from chemically treated tissues, the durability of which is based on the stability of the tissue, not on cell regeneration.12 The main advantage of a bioprosthesis over a mechanical valve is the lower risk of thromboembolism, avoiding the need for anticoagulation. Starr advised Edwards' laboratory, the manufacturer of his own prosthesis, to develop a tissue valve with Carpentier; the Carpentier-Edwards porcine valve remains one of the most widely used prostheses today and is the model on which most bioprostheses are still based10 (incorporating features such as glutaraldehyde tissue ...

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