Efficacy of a nitinol filter device in the prevention of embolic events during carotid interventions.

PURPOSE: To evaluate the feasibility, safety, and efficacy of the TRAP Vascular Filtration System (VFS) during carotid interventions as a deterrent to embolic complications.

METHODS

Thirty-one consecutive patients (18 men; mean age 72 +/- 8 years) gave informed consent to undergo elective percutaneous angioplasty and stenting of the extracranial carotid artery protected by the TRAP VFS, a nitinol basket filter system.

RESULTS

The TRAP VFS was delivered and retrieved safely in all patients; procedural success for carotid stenting was 100%. In 3 (9.7%) cases, the filters were positioned after lesion predilation. Nearly half (13, 41.9%) of the retrieved filters contained visible plaque debris that histology identified as cholesterol crystals, fibrin material, atheromatous plaque, and macrophage foam cells. There were no symptomatic major or minor neurological complications encountered in this cohort during hospitalization.

CONCLUSIONS

Our data indicate that percutaneous dilation and stenting of the carotid artery protected by TRAP VFS appears to be feasible, safe, and effective in preventing cerebral embolization.