CardiaMed mechanical valve: mid-term results of a multicenter clinical trial.

Background: Prosthesis choice is a major concern in valvular surgery.

Methods: A multicenter clinical trial was performed to assess the efficacy and safety of the CardiaMed prosthetic heart valve. The study enrolled 420 patients who underwent mitral (209) or aortic (211) valve replacement from 2003 to 2004 at 7 institutions in Russia, and who were followed up from 2006 to 2011. The mean age was 52.2 ± 10.2 years (range, 12-78 years), 47.4% were female, and 99.05% completed the study.

Results: The maximum observation term was 7.5 years (2188.5 patient-years); 1081.6 patient-years for aortic and 1106.9 patient-years for mitral valve replacement. The overall 7-year survival rate was 85.1%  ± 3.7%; 86.1%  ± 4.8% and 84.4%  ± 5.4% for aortic and mitral valve replacement, respectively. The 7-year freedom from valve-related death was 93.9%  ± 3.7% and 94.5%  ± 3.2% for aortic and mitral valve replacement, respectively. When early mortality (<30 days) was excluded, these rates were 94.8%  ± 3.1% and 93.8%  ± 3.82%, respectively. Linearized valve-dependent complication rates were determined for structural valve failure (0%/patient-year overall), thrombosis (0.63%/patient-year, all for mitral valve replacement), thromboembolic complications including transient neurologic deficits (0.13%/patient-year overall, 0.5%/patient-year for aortic valve replacement, 0.8%/patient-year for mitral valve replacement), hemorrhagic bleeding (0.64%/patient-year overall, 0.55%/patient-year for aortic valve replacement, 0.09%/patient-year for mitral valve replacement), prosthetic endocarditis (0.28%/patient-year overall, 0.28%/patient-year for aortic valve replacement, 0%/patient-year for mitral valve replacement), and hemolysis (0%/patient-year overall).

Conclusion: The CardiaMed mechanical heart valve prostheses meets world standards of safety and efficacy.