Oclusão percutânea do forame oval patente com prótese PREMEREtm: resultados preliminares da primeira experiência no Brasil / Percutaneous occlusion of patent foramen ovale with the PREMERE TM device: preliminary results of the first experience in Brazil

RESUMO

INTRODUÇÃO: O forame oval parente ocorre em 27 por cento a 30 por cento da população e pode estar associado a eventos embólicos, dentre eles o acidente vascular cerebral criptogênico. A prótese PREMEREtm. especialmente desenvolvida para a correção do forame oval patente, apresenta baixo perfil, reduzida quantidade de metal e âncora no lado esquerdo, com reduzida superfície para minimizar o risco de formação de trombos. Avaliamos os resultados clínicos e ecocardiográficos imediatos e aos três e seis meses pós-implante do dispositivo. Métodos: Entre maio de 2008 e junho de 2009, a prótese foi implantada em 14 pacientes com forame oval patente e que apresentaram eventos embólicos cerebrais prévios, comprovados por tomografia computadorizada e/ou ressonância nuclear magnética de crânio. O diagnóstico ecocardiográfico de forame oval patente foi realizado quando microbolhas...

ABSTRACT

BACKGROUND: Patent foramen ovale is observed in 27% to 30% of the population and may be associated to embolic events, among them the cryptogenic stroke. The PREMERE TM device, specially developed to correct patent foramen ovale, has a low profile, reduced amount of metal and a left anchor with a small total surface to minimize the risk of thrombus formation. Clinical and echocardiographic results were evaluated immediately after the procedure and 3 and 6 months after device implantation. METHOD: From May 2008 to June 2009, the device was implanted in 14 patients with patent foramen ovale with prior cerebral embolic events, confirmed by computerized tomography and/or cranial magnetic resonance imaging. Echocardiographic patent foramen ovale was diagnosed when microbubbles were detected in the left atrium within three heartbeats after opacification of the right atrium. Patients with patent foramen ovale with interatrial septal aneurysm > 2 cm, those with atrial fibrilation/flutter or with other diseases that might explain the cryptogenic stroke were excluded. RESULTS: Nine (64.3%) patients were male and mean age was 47.2 ± 17.5 years. Successful implantation was achieved in 100% of the cases. Transesophageal echocardiogram immediately after the procedure showed the presence of microbubbles in the left atrium with Valsalva maneuver in 50% of the cases. All of the patients were discharged the following day, receiving acetyl salicylic acid 200 mg/day and clopidogrel 75 mg/day and returned after 3 months for clinical and echocardiographic follow-up. The transesophageal echocardiogram at three months showed a mild residual flow in only 3 (21.4%) patients. These patients had a totally occluded patent foramen ovale at the 6-month follow-up transesophageal echocardiogram. None of the patients had cardiovascular events during the follow-up period. CONCLUSION: The PREMERE TM device proved to be safe and effective in the occlusion of patent foramen ovale. The occlusion rate in this initial experience was high for a follow-up period of 6 months.