Duromedics original prosthesis: what do we really know about diagnosis and mechanism of leaflet escape?

The Edwards-Duromedics (ED) is a bileaflet pyrolitic carbon mechanical valve introduced by Hemex Scientific Inc in 1982, subsequently acquired by Baxter Healthcare Corp, withdrawn from the market in 1988, and modified and reintroduced in 1990. From 1982 to date, 46 cases of leaflet escape have been registered by the manufacturer of an estimated total of 20,000 valves implanted. Disc embolization 12 years after an ED mitral prosthesis implantation is reported in a 45-year-old man operated on when he was in cardiogenic shock because a preliminary transthoracic Doppler echocardiography did not show malfunction of the valve. A correct diagnosis was made four days after the onset of the symptoms by transesophageal echocardiography. During the operation, the posterior leaflet of the ED valve was not found, a 29 mm St Jude Medical bileaflet mechanical prosthesis was implanted and the patient died in the intensive care unit because of low cardiac output syndrome. Cavitation damage is generally considered the most frequent mechanism in cases of such fracture. Thus, any patient with a mechanical valve presenting with acute pulmonary edema must be immediately transferred to a surgical unit; cinefluoroscopy or transesophageal echocardiography may be performed rapidly to achieve successful management of patients with leaflet embolization.