The Results of the Multicenter Study of the Use of “Uniline” Biological Prosthesis in Mitral Valvular Disease

Natalia V. Rogulina ¹, Sergei I. Zheleznev ², Alexander V. Bogachev-Prokofiev ², Alexey N. Pivkin ², Eduard M. Idov ³, Alexander V. Mikhailov ³, Kristina A. Zykova ³, Yuri N. Odarenko ¹, Alexander M. Karaskov ², Leonid S. Barbarash ¹

¹ Federal State Budgetary Institution “Research Institute for Complex Issues of Cardiovascular Diseases” , Kemerovo, Russia; ² Federal State Budgetary Institution “Academician Ye.N. Meshalkin National Medical Research Center” of the Ministry of Healthcare of the Russian Federation, the Russian Federation, Novosibirsk, Russia; ³ State Budgetary Healthcare Institution of the Sverdlovsk Region “Sverdlovsk Regional Clinical Hospital 1”, the Russian Federation, Ekaterinburg, Russia;

Date, time and location: 2018.05.26 13:30, Congress Hall, 2F–B

Abstract

Purpose: We aimed to analyze the immediate and long-term (up to 8 years) results of multicenter surgical treatment of mitral valvular disease with the application of “UniLine” biological prosthesis.

Material and methods:From 2009 to 2017 393“UniLine” prostheses were implanted to patients of the mean age67.2±5.1 yearsin mitral valve correction in two clinics of the Siberian and in one clinic of the Ural Federal District.  In 12% of the patients the intervention was repeated and in 36.3% - combined. The averagetime and the scope of observation were3.7±2.5 years (1151patient-years). 

Results. The in-hospital mortalitywas 6.1%. The actuarial survival index by the 8^th year of follow-up was 95.7% and thelinearized survival index was1.4%/patient-years. Non-cardiac causes(56.3%)prevailed in the structure of the long-term mortality.Three cases of valve-related fatal outcomes were developed in residents of remote areas, who did not take antibacterial therapy for prophylaxis (n=2, prosthetic endocarditis) and had difficulties with the control of anticoagulant therapy (n=1, acute cerebrovascular accident). 11 patients were reoperated,the linearized index of reoperations was0.96% /patient-years and the actuarialindex of the absence of repeated interventions was97.1% by the 8^th year. The causes of reoperated dysfunctions were prosthetic endocarditis (n=5) and primary tissue degeneration with calcification (n=6). The actuarial index of the absence of dysfunctions by the 8^th year of follow-up was 96.3%. 27.9% of the patients received anticoagulant therapy for atrial fibrillation in the long-term period. Thelinearized indices of bleedings and thromboembolismwere 0.35 and 0.13% /patient-years andthe actuarial indices of hemorrhagic and thromboembolic complications didn’t exceed 98.9% and 99.5% by the 8^th year of follow-up, correspondingly.

Conclusion:The application of “UniLine” bioprosthesis in mitral valvular disease in elderly patients demonstrated high survival rates and a low risk of dysfunction during eight years after implantation. More than 70% of the bioprostheses recipients have sinus rhythm in the long-term period which practically eliminates the risk of hemorrhagic and thromboembolic complications.