RESUMO
PURPOSE: To evaluate the safety and effectiveness of a new system to facilitate intraluminal advancement of conventional guidewires through chronic total occlusions (CTO) of the superficial femoral artery (SFA) and popliteal artery. METHODS: The ENABLER-P Balloon Catheter System uses a unique balloon-anchoring mechanism and an automated balloon inflation device for steady, controlled advancement of a standard non-hydrophilic guidewire. The system was evaluated in 37 patients (22 men; mean age 67 years (range 41-87) with femoropopliteal CTOs averaging 86 mm in length (range 10-340). The device was used in a variety of occlusions, including heavily calcified, long, and fibrotic lesions. After successful guidewire recanalization facilitated by the system, occluded arterial segments were treated conventionally with balloon angioplasty, atherectomy, and stents as appropriate. RESULTS: The primary endpoint of successful crossing was achieved in 86% (32/37) of the overall study population. The average activation time for successful crossing was 5.3 minutes (range 0.4-22). Of the 32 cases successfully crossed with the ENABLER-P System, all but 1 was successfully recanalized. One (3%) device-related complication occurred when the wire was advanced into a side branch when treating a 300-mm-long flush ostial SFA occlusion; the resulting perforation was managed with a covered stent without further sequelae. CONCLUSION: This novel system, which provides enhanced force to a standard guidewire tip for controlled intraluminal advancement, is a promising device for the treatment of peripheral CTOs.
Assuntos
Angioplastia com Balão/instrumentação , Arteriopatias Oclusivas/terapia , Catéteres , Artéria Femoral , Artéria Poplítea , Calcificação Vascular/terapia , Adulto , Idoso , Idoso de 80 Anos ou mais , Angioplastia com Balão/efeitos adversos , Arteriopatias Oclusivas/diagnóstico por imagem , Brasil , Doença Crônica , Constrição Patológica , Desenho de Equipamento , Estudos de Viabilidade , Artéria Femoral/diagnóstico por imagem , Artéria Femoral/lesões , Fibrose , Alemanha , Humanos , Israel , Masculino , Pessoa de Meia-Idade , Artéria Poplítea/diagnóstico por imagem , Estudos Prospectivos , Radiografia Intervencionista , Stents , Resultado do Tratamento , Calcificação Vascular/diagnóstico por imagem , Lesões do Sistema Vascular/etiologia , Lesões do Sistema Vascular/terapiaRESUMO
Purpose: To evaluate the safety and effectiveness of a new system to facilitate intraluminaladvancement of conventional guidewires through chronic total occlusions (CTO) of thesuperficial femoral artery (SFA) and popliteal artery.Methods: The ENABLER-P Balloon Catheter System uses a unique balloon-anchoringmechanism and an automated balloon inflation device for steady, controlled advancementof a standard non-hydrophilic guidewire. The system was evaluated in 37 patients (22 men;mean age 67 years (range 4187) with femoropopliteal CTOs averaging 86 mm in length(range 10340). The device was used in a variety of occlusions, including heavily calcified,long, and fibrotic lesions. After successful guidewire recanalization facilitated by thesystem, occluded arterial segments were treated conventionally with balloon angioplasty,atherectomy, and stents as appropriate.Results: The primary endpoint of successful crossing was achieved in 86% (32/37) of theoverall study population. The average activation time for successful crossing was5.3 minutes (range 0.422). Of the 32 cases successfully crossed with the ENABLER-PSystem, all but 1 was successfully recanalized. One (3%) device-related complicationoccurred when the wire was advanced into a side branch when treating a 300-mm-longflush ostial SFA occlusion; the resulting perforation was managed with a covered stentwithout further sequelae.Conclusion: This novel system, which provides enhanced force to a standard guidewire tipfor controlled intraluminal advancement, is a promising device for the treatment ofperipheral CTOs.