Initial experience with a reversal-of-flow cerebral protection device in carotid angioplasty Experiência inicial com dispositivo de revers o de fluxo para prote o cerebral na angioplastia carotídea

PURPOSE: To report initial findings with the GORE Flow Reversal System , with a focus on major/minor adverse events in the 30 first postoperative days. METHODS: The first 24 patients submitted to carotid angioplasty using the GORE system, from June 2010 to May 2012, were retrospectively assessed with regard to indications, anatomic details, technical difficulties, and early clinical outcomes, including major (stroke, death, acute myocardial infarction) and minor (hematoma) adverse events. RESULTS: Systemic hypertension was present in 100% of the patients, diabetes mellitus in 58.3%, and coronary disease in 37.5%. Type II aortic arch was encountered in 62.5% of the patients and atherosclerotic lesion predominantly at the carotid bifurcation affecting the internal and common carotid arteries in 79.2%. Angiographic data revealed contralateral carotid arteries with <50% stenosis in 95.8% of cases and preservation of cerebral blood flow in 95.8%. All procedures but one were technically successful. Mean cerebral flow reversal time was 14.9 minutes, with a statistically significant difference between the first 12 (17.9 minutes) and the last 12 patients treated (11.6 minutes) (p<0.001). Intolerance to flow reversal was observed in 17.4% of the cases. Technical difficulties were experienced in 1 patient (4.2%). Clinical outcomes included 4.2% of stroke and 12.5% of hematomas at arterial puncture sites. CONCLUSION: The system was technically effective. A significant reduction in cerebral flow reversal time was observed, and the rates of early major/minor adverse events were within acceptable limits, suggesting that the device is safe and effective. OBJETIVO: Relatar os achados iniciais da utiliza o do GORE Flow Reversal System (Sistema de Fluxo de Revers o), com foco em eventos adversos maiores/menores nos primeiros 30 dias do pós-operatório. MéTODOS: Os primeiros 24 pacientes submetidos a angioplastia carotídea com a utiliza o do sistema GORE, de junho de 2010 a maio de 2012, foram avaliados retrospectivamente com rela o a indica es, detalhes anat micos, dificuldades técnicas e desfechos clínicos imediatos, incluindo eventos adversos maiores (acidente vascular cerebral, morte, infarto agudo do miocárdio) e menores (hematoma). RESULTADOS: Hipertens o sistêmica estava presente em 100% dos pacientes, diabete melito em 58,3% e doen a coronariana em 37,5%. Arco aórtico tipo II foi encontrado em 62,5% dos pacientes e les o de aterosclerose predominantemente na bifurca o carotídea que afeta as artérias carótidas internas e comuns em 79,2%. Dados angiográficos reve