New Braile Inovare transcatheter aortic prosthesis: clinical results and follow-up.
OBJECTIVE
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.


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.
Cardiovascular Surgery Department, Federal University of São Paulo, São Paulo, Brazil.
Diego Felipe
DF
Gaia
João Roberto
JR
Breda
Carolina Baeta Neves
CB
Duarte Ferreira
José Augusto
JA
Marcondes de Souza
Murilo Teixeira
MT
Macedo
Marcus Vinícius
MV
Gimenes
Aline
A
Couto
Matheus
M
Simonato
Luis Furlan
LF
Financi
Enio
E
Buffolo
José Honório
JH
Palma
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve / Q000000981:diagnostic imaging / Q000473:pathology* / Q000503:physiopathology; D001022:Aortic Valve Insufficiency / Q000209:etiology; D001024:Aortic Valve Stenosis / Q000175:diagnosis / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D002114:Calcinosis / Q000175:diagnosis / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods / Q000401:mortality; D002304:Cardiac Pacing, Artificial; D005260:Female; D005500:Follow-Up Studies; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods / Q000401:mortality; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D011474:Prosthesis Design; D011859:Radiography; D012307:Risk Factors; D020521:Stroke / Q000209:etiology; D013997:Time Factors; D016896:Treatment Outcome; D014463:Ultrasonography