The Spanish Monostrut Study Group: a ten-year experience with 8,599 implants.

BACKGROUND

The Monostrut valve is a pyrolytic carbon, tilting-disc prosthesis with no welds. After the first implantation in Spain in May 1983, the Spanish Monostrut Study Group was established to evaluate prospectively the performance of the valve using uniform protocols.

METHODS

During a 10-year period, 8,599 Monostrut valves were implanted in 7,317 patients in 22 centers. Mean age was 53.3 +/- 11 years. Of the total group, 3,229 underwent aortic valve replacement, 2,806 had mitral valve replacement, and 1,282 had double valve replacement. Follow-up was 96% complete, with a mean period of 4.3 years and a total of 29,155 patient-years.

RESULTS

The operative mortality rate was 7.2%. The 10-year probability of freedom from valve-related complications and linearized rates (event/100 patient-years in parentheses) were as follows: structural deterioration, 100% (0); nonstructural dysfunction, 96% +/- 0.5% (0.51); thromboembolism, 82.9% +/- 1.5% (1.32); anticoagulant-related hemorrhage, 87.6% +/- 1.4% (0.98); and prosthetic valve endocarditis, 96.1% +/- 0.5% (0.48). There were five obstructive valve thromboses (0.017/100 patient-years). Actuarial freedom from reoperation was 95% +/- 0.5% at 10 years. Actuarial freedom from all valve-related morbidity was 70.2% +/- 1.6%; freedom from all valve-related morbidity and mortality (including operative and sudden deaths) was 62.6% +/- 2% (70.1% +/- 2% for aortic valve replacement, 56.9% +/- 2% for mitral valve replacement, and 59.8% +/- 3% for double valve replacement; p < 0.0001). Clinically, 5,988 patients (94%) are in New York Heart Association class I-II.

CONCLUSIONS

The Monostrut valve has shown no structural failures and a low rate of valve-related complications over a 10-year period in a large patient population.