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 52.210.2 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%/patientyear
for mitral valve replacement), and hemolysis (0%/patient-year overall).
Conclusion: The CardiaMed mechanical heart valve prostheses meets world standards of safety and efficacy.
Aortic valve, follow-up studies, heart valve prosthesis, heart valve prosthesis implantation, mitral valve