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Transcatheter aortic valve implantation has emerged as an alternative to conventional aortic valve replacement in high-risk patients. Despite promising results early devices faced diverse limitations including paravalvular leak contributing to an increase mortality when present. The aim of this study was the first in man clinical, safety and efficacy assessment of the New Braile Inovare Proseal Transcatheter Prosthesis usage.
13 high risk or inoperable patients underwent transcatheter aortic valve implantation using a new transcatheter prosthesis with a novel system to prevent paravalvular leak. The mean Logistic EuroSCORE was 12,5 %. All patients presented calcified aortic stenosis. The procedures were performed under fluoroscopic and echocardiographic guidance. Prostheses were implanted through transapical approach under rapid ventricular pacing. Echocardiographic and angiographic controls were included.
Implantation was feasible in all cases. There was no operative mortality and 1 case presented 30 day mortality. The median transvalvular aortic gradient was reduced from 44,2±13 to 7,3±2,1 mmHg. Paravalvular aortic regurgitation was none in 11 cases and trace in 2 cases. At 12 months follow-up 10 cases presented with no aortic regurgitation and 2 mild. No VARC-2 complications were reported. Follow-up ranged from 1 to 16 months.
Transcatheter aortic valve replacement using the new Braile Inovare Proseal prosthesis is able to provide encouraging results with significant decrease in paravalvular leak. Adequate clinical results and no complications (thrombosis/coronary occlusion/AV Block) were reported. It is mandatory to continue follow-up to measure the benefit.
STRUCTURAL: Valvular Disease: Aortic