NEXT GENERATION RUSSIAN BIOLOGICAL PROSTHESIS "UNILIN" FOR MITRAL VALVE REPLACEMENT: FIRST EXPERIENCE
Introduction. Biological xenopericardial prosthesis "UniLin" used in clinical practice since 2008. In the manufacture of the prosthesis of the third generation, introduced several new technologies: laser cutting for thick biological tissues, anticalcium aminolevulinate processing, spatial modeling and composite frame, as well as the absence of synthetic materials in producing the cuff of the prosthesis. The aim of this work was to evaluate the immediate and mid-term results of biological valves “UniLin” in mitral position. Material and methods. For the period from January 2009 to April 2015 about the mitral lesions 215 patients implanted biological prosthesis “UniLin”. The average time and amount of follow-up was 2.3 ± 2.1 (0.1 to 5.9) years and 463.4 patient-years, respectively. The average age of recipients “UniLin” was of 66.5 ± 9.7 years. In 68.1% of cases the cause of mitral heart disease was chronic rheumatic heart disease. Average functional class according to the classification of New York Heart Association was 2.86 ± 0.2. 2B stage of heart failure before the operation had 25% of patients. Atrial fibrillation was observed in 65.1% of patients. The present intervention was repeated for 28.4% of operated. Isolated mitral valve replacement performed in 88 (41%) patients. Results. Hospital mortality was 5.1%. In the structure of hospital mortality prevailed syndrome of multiple organ failure (54.5%). The linearized remote mortality rate was 2.6%/patient-year, the actuarial survival rate to the end of the fifth year of observation was 91%. In the structure of remote lethality prevailed not cardiac reasons (41.7%). The linearized rate of reoperations was 0.86%/patient-year, the actuarial indication of the absence of reoperations by the end of the 5 years of follow-up was 96.5%. The linearized rate of prosthetic endocarditis and primary tissue failure with calcification was 0.65 and 0.22%/patient-year, respectively. 74 (36.3%) patients in the remote period took anticoagulant therapy. The linearized rate of bleeding and embolism in the treatment group was 0.43 and 0.22%/patient-year, respectively. The actuarial indication of the absence of bleeding by the end of the fifth year of follow-up was 99%, thromboembolism - 98.5%. Conclusion. The biological of xenopericardial prosthesis “UniLin” implantation in mitral position, ensuring a high survival rate in patients of all ages by adequate correction of haemodynamics, leading to a complete remodeling of the left atrium and a significant decrease in the level of pulmonary hypertension. No synthetic components in the design of the prosthesis improves the stability of the biological valve “UniLin” to the development of prosthetic endocarditis. The bioprosthesis “UniLin” need implantation the patients with low adherence to drug therapy and patients who are unable adequate monitoring of anticoagulant therapy.