Key result
Braile Inovare TAVR shows feasibility in high-risk patients with ~13% 30-day mortality and reduced aortic gradients.
Why the study?
Does the Braile Inovare transcatheter aortic prosthesis improve clinical and hemodynamic outcomes in high-risk or inoperable patients with calcified aortic stenosis?
Observational (n=90)
Does the Braile Inovare transcatheter aortic prosthesis improve clinical and hemodynamic outcomes in high-risk or inoperable patients with calcified aortic stenosis?
Answers are grounded in this paper and cite their sources.
The Braile Inovare transcatheter aortic prosthesis demonstrates feasibility and significant reduction in transvalvular gradients in high-risk or inoperable patients with calcified aortic stenosis, though with a 13.3% 30-day mortality.
AIMS: Transcatheter aortic valve implantation has emerged as an alternative to conventional aortic valve replacement in high-risk patients. Diverse prostheses are currently under investigation. The aim of this study was the clinical, safety and efficacy assessment of Braile Inovare Transcatheter Aortic Prosthesis usage. METHODS AND RESULTS: Ninety high-risk or inoperable patients underwent transcatheter aortic valve implantation. The mean logistic EuroSCORE was 39.3%. All patients presented calcified aortic stenosis. The procedures were performed under fluoroscopic and echocardiographic guidance. Prostheses were implanted through the transapical approach under rapid ventricular pacing. Echocardiographic and angiographic controls were included. Implantation was feasible in 87 cases. There was only one case of operative mortality, and 30-day mortality was 13.3%. The median transvalvular aortic gradient was reduced from 44.8±15.3 to 14.1±8.0 mmHg. Left ventricular function improved in the first seven postoperative days. Paravalvular aortic regurgitation was present in 29.7% of cases, mostly trace. One case presented a major vascular complication, and there were two cases of permanent pacemaker implantation. Two cases of major stroke occurred. CONCLUSIONS: Transcatheter aortic valve replacement using the Braile Inovare prosthesis is able to provide encouraging results with significant functional and structural cardiac improvement. It is mandatory to continue follow-up to measure the benefits of this device as well as to improve selection criteria of patients.
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Gaia et al. (2015) conducted an observational in calcified aortic stenosis (n=90). Braile Inovare Transcatheter Aortic Prosthesis was evaluated on 30-day mortality. Transcatheter aortic valve replacement using the Braile Inovare prosthesis in high-risk patients was feasible in 87 of 90 cases, with a 30-day mortality of 13.3% and reduced aortic gradients.
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