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1 . 2023

The results of the long-term isolated use of xenopericardial bioprosthesis of the new generation TiAra in the long-term period

Abstract

Aim. To study the efficacy and safety of the functioning of the new semi-frame bioprosthesis TiAra in the long-term after surgery in patients with different sizes of native aortic annulus.

Material and methods. The study included 48 patients: 33 women with degenerative AV stenosis, mean age 69 (65; 72) years. Shortness of breath in 100% of patients, angina syndrome in 30 (62.5%) of them, pre- and syncope in 15 (31.25%). The average gradient on the AK is more than 49 mm Hg. All of them had left ventricular (LV) hypertrophy – interventricular septum 14 (12; 17) mm. Before the operation, all of them had functional class III (FC), the distance of the 6-minute walk test (6MWT) was 250 (180; 290) m. In 23 patients valves were implanted with a seat size of 23 mm, in 19–21 mm, in 6–25 mm. Standard examination: physical examination, echocardiog raphy (EchoCG), 12-lead ECG, 6MWT, ECG Holter monitoring. Control points of observation: before discharge from the hospital and every 12 months after surgery. The mean follow-up period was 28 (18; 36) months.

Results. All 48 patients noted an improvement in their condition before discharge: shortness of breath, angina pectoris, and episodes of syncope disappeared. FC heart failure - class II, the distance of the 6MWT increased from 250 to 325 (180; 400) m. Echocardiography at discharge revealed a statistically significant decrease in the flow velocity in the aortic root from 450 (427; 475) to 225 (195; 252 ) cm/s (р=0.03) and transvalvular gradients: peak from 81 (71; 92) to 21 (16; 25) mm Hg (р=0.03) and average from 49 (40; 52) to 12 (7; 14) mm Hg (р=0.03). LV ejection fraction before surgery 64 (53; 69)%, after 60 (52; 65)%. 3 (6.3%) patients died in the long-term period, there were no deaths from cardiac causes. During the follow-up examination, the tr ansprosthetic flow was 400 (350; 470) m. According to echocardiography, the transprosthetic flow was 220 (185; 245) cm/s (р=0.02), the indicators of the transvalvular gradient decreased: peak 19 (14; 23) mm Hg (р=0.03) and average 10 (6; 14) mm Hg (р=0.03). The LV ejection fraction was 67% (54; 70) (р=0.03). In one case, a pacemaker was implanted due to the development of second-degree AV blockade, Mobitz 2. In two cases, prosthesis dysfunction was detected, which occurred within a year after the operation.

Conclusion. The absence of valve-related mortality, low incidence (6.3%) of dysfunctions, and stability of hemodynamic parameters allow us to state that the use of xenopericardial semi-frame bioprosthesis TiAra in the treatment of degenerative AV defects is effective and safe in the long-term period.

Keywords:biological prosthesis; TiAra; aortic valve; aortic valve replacement; degenerative disease; prosthesis dysfunction

Funding. The study had no sponsor support.
Conflict of interest. The authors declare no conflict of interest.
For citation: Evtushenko A.V., Lebedev D.I., Shcherbakov K.Yu., Shabaldin A.V., Afanasiev V.I., Deeva N.S., Veselovskaya N.G., Barbarash L.S. The results of the long-term isolated use of xenopericardial bioprosthesis of the new generation TiAra in the long-term period. Clinical and Experimental Surgery. Petrovsky Journal. 2023; 11 (1): 77–85. DOI: https://doi.org/10.33029/2308-1198-2023-11-1-77-85  (in Russian)

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CHIEF EDITOR
CHIEF EDITOR
Sergey L. Dzemeshkevich
MD, Professor (Moscow, Russia)

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