All patients undergoing a heart valve replacement with a glutaraldehyde Carpentier-Edwards xenograft from April 1978 through December 1980 were reviewed. This analysis included 189 patients: 117 having a mitral valve replacement (MVR), 45 having an aortic valve replacement (AVR), and 27 having mitral and aortic valve replacements (MAVR). Out of 174 patients discharged from the hospital, one was lost to follow-up and is excluded from the analysis. There were 11 late deaths, which represent an incidence of 1.89% per patient-year for the MVR (6/106), 0.83% per patient-year for the AVR (1/41), and 5.83% per patient-year for the MAVR (4/26). There were 6 instances of infective endocarditis (4 MVR, 2 MAVR), which represent a linearized incidence o 1.26% and 2.91% per patient-year for the MVR and MAVR respectively. All were successfully treated with medication. There were 10 thromboembolic events in 7 patients (6 MVR had 9 events and 1 AVR had 1 event). This represents a linearized incidence of 2.84% and 0.83% per patient-year for MVR and AVR, respectively. Primary tissue failure was observed in 3 patients (2 MVR, 1 MAVR), who required reoperation for explantation of the mitral valves. This represents an overall linearized incidence of mitral failures of 0.78% per patient-year. The probability of being free from primary tissue failure is 95.9 +/- 4.9% for all mitral prostheses at 4.5 years of follow-up. These current results indicate that the Carpentier-Edwards porcine xenograft valve can be considered as a valid alternative for heart valve replacement.