Efficacy of a filter device in the prevention of embolic events during carotid angioplasty and stenting: An ex vivo analysis

Objective: Although percutaneous angioplasty and stenting (PTAS) of carotid bifurcation lesions is feasible and appropriate for surgically inaccessible lesions, its general role and comparative value remain unclarified. Moreover, the acceptance of carotid PTAS has been limited by its potential for producing embolic debris. This study used an ex vivo model to evaluate the efficacy of a novel filter device to entrap emboli during PTAS of human carotid plaques. Methods: Eight carotid bifurcation plaques were obtained from patients who underwent carotid endarterectomy for high-grade atherosclerotic stenosis(>90%). The mean age of the patients was 63 years, and six patients were symptomatic. Each plaque was encased with polytetrafluoroethylene material to simulate adventitia and was connected to a perfusion circuit, which provided continuous flow through the plaque. The filter device consisted of an expandable polymeric membrane with multiple micro pores that was attached to the distal end of a 0.014-in wire with a shapeable tip. This filter was encased in a delivery catheter. With fluoroscopic guidance, the filter wire was passed through the stenosis and the delivery catheter was then retracted to open the filter to capture particles released into the distal internal carotid artery. PTAS with a self-expandable stent then was carried out over the filter wire. The particles released during the initial filter passage, those captured in the filter, and those that flowed through or around the filter (missed) mere collected and analyzed with light microscopy. Results: Eater deployment, PTAS, and filter retrieval were achieved successfully with each lesion. Because the filter has a low crossing profile, it passed through the stenoses smoothly and only produced occasional small particles. PTAS improved the angiographic stenosis from 96.2% +/- 3.7% to 1.3% +/- 1.6%. The mean number and the maximum size of the particles that were released during initial filter passage, missed, and captured by the filter device were 3.1 and 500 mu m, 2.8 and 360 mu m, 20.1 and 1100 mu m, respectively. Most of the particles and those of large size were released during PTAS, The filter captured 88% of these particles. Conclusion: These study results show that this filter device, at least in this model, did not add complexity to the interventional procedure itself. Furthermore, the filter may markedly decrease embolic events during carotid PTAS and expand the indications for this procedure.