Initial experience with a reversal-of-flow cerebral protection device in carotid angioplasty / Experiência inicial com dispositivo de reversão de fluxo para proteção 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 utilização do GORE Flow Reversal System® (Sistema de Fluxo de Reversão), 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 utilização do sistema GORE, de junho de 2010 a maio de 2012, foram avaliados retrospectivamente com relação a indicações, detalhes anatômicos, dificuldades técnicas e desfechos clínicos imediatos, incluindo eventos adversos maiores (acidente vascular cerebral, morte, infarto agudo do miocárdio) e menores (hematoma). RESULTADOS: Hipertensão sistêmica estava presente em 100% dos pacientes, diabete melito em 58,3% e doença coronariana em 37,5%. Arco aórtico tipo II foi encontrado em 62,5% dos pacientes e lesão de aterosclerose predominantemente na bifurcação carotídea que afeta as artérias carótidas internas e comuns em 79,2%. Dados angiográficos revelaram artérias carótidas contralaterais com estenose <50% em 95,8% de casos e preservação de fluxo sanguíneo cerebral em 95,8%. Todos os procedimentos, com exceção de um, foram tecnicamente bem sucedidos. A média do tempo de reversão do fluxo cerebral foi de 14,9 minutos, com uma diferença estatisticamente significativa entre os primeiros 12 pacientes (17,9 minutos) e os últimos 12 pacientes tratados (11,6 minutos) (p<0,001). Intolerância à reversão de fluxo foi observada em 17,4% dos casos. Ocorreram dificuldades técnicas em 1 paciente (4,2%). Desfechos clínicos incluíram 4,2% de acidente vascular cerebral e 12,5% de hematomas em locais de punção arterial. CONCLUSÃO: O sistema foi tecnicamente eficaz. Uma redução significativa no tempo de reversão do fluxo cerebral foi observada e as taxas de eventos adversos maiores/menores ficaram dentro de limites aceitáveis, sugerindo que o dispositivo é seguro e eficaz.

Carotid artery stenting with filter protection.

BACKGROUND: Neurologic events associated with distal embolization of debris during percutaneous carotid artery stenting complicate the procedure. Filter devices for cerebral protection potentially reduce the risk of embolization and other neurologic events. We studied the feasibility, safety, and efficacy of carotid artery stenting with a filter device. METHODS AND RESULTS: Between January 2002 and January 2003, a total of 22 consecutive patients (30 lesions) who had >70% diameter stenosis of the internal carotid artery underwent carotid artery stenting with filter protection at our institute. The mean age of the patients was 64+/-9 years; 14 were men and 8 women, and 15 had neurologic symptoms. A stent was successfully implanted in 29 lesions. It was possible to position a filter device in all the 29 lesions. Neurologic complications during the procedure, in the hospital, and at 30-day clinical follow-up occurred in 2 patients. One patient suffered a minor stroke that resolved within 24 hours. None of the patients had a major embolic stroke. There was one death from intracerebral hemorrhage related to hyperperfusion and the use of a glycoprotein IIb/IIIa inhibitor. CONCLUSIONS: Filter protection during carotid artery stenting seems technically feasible, safe, and effective. In the present study, the incidence of embolic neurologic events was low.