Objectives
This study aimed to examine very-long-term outcomes of a mechanical valve at the mitral position.
Methods
This study included all patients who underwent mitral valve replacement using a mechanical valve including urgent operation at the Department of Cardiovascular Surgery, Hyogo Brain and Heart Center, Himeji, from January 1987 to December 2015.
Results
Five hundred and eighty three patients (277 men [47.51%]; age, 61 [54–67] years) were included in this study. The implanted valve models were as follows: SJM 221(37.91%), ATS 35(6.00%), On-X 68(11.66%), and Carbomedics 194(33.28%).The median clinical follow-up duration was 13.3 (7.4–19.6) years. The survival rates at 10, 15, 20, and 25 years were 81.42%, 69.27%, 56.34%, and 45.03%, respectively. Thromboembolism was observed in 38 patients, and the linearized ratio for each event was 0.626%/patient-year(95% confidence interval, 0.443%–0.859%). Intracranial Haemorrhage and gastrointestinal bleeding were observed in 26 and 9 patients, and the linearized ratio for each event was 0.425%/patient-year (95% confidence interval, 0.277%–0.006%) and 0.145%/patient-year (95% confidence interval, 0.067%–0.276%), respectively. Major paravalvular leak was observed in 32 patients, and the linearized ratio was 0.532%/patient-year (95% confidence interval, 0.364%–0.751%). The cumulative incidence rate of major paravalvular leak at 10, 15, 20, and 25 years were 3.7%, 5.6%, 6.4%, and 10.4%, respectively. Multivariable Cox regression analysis revealed that repeated mitral valve replacement and male gender were associated with major paravalvular leak.
Conclusion
Male gender and repeated mitral valve replacement were risk factors for paravalvular leak after mechanical mitral valve replacement. Paravalvular leak could have occurred regardless of postoperative period even at 25 years after implantation. Lifelong clinical follow-up is considered necessary.