Abstract
Purpose: To report the results from a single-center prospective registry (PROTECT)established to evaluate the safety and effectiveness of embolic filter protection (EFP) inreducing distal embolization during percutaneous lower extremity interventions.Methods: Patients undergoing angioplasty, stenting, or SilverHawk atherectomy andadjunctive balloon angioplasty for infrainguinal occlusive disease were eligible if thelesion(s) met one or more of these angiographic criteria: (1) moderate or severecalcification of any length, (2) total occlusions of any length, (3) a filling defect, (4)irregular (ulcerated) lesions at least 30 mm in length, and/or (5) smooth, non-ulceratedlesions at least 50 mm in length. The primary angiographic outcome was the ability of thefilter to prevent angiographically visible distal embolization, slow flow, and loss of distaltibial runoff with or without capturing macrodebris.Results: Forty patients (23 men; mean age 71.4611.5 years) with 56 lesions (42 de novoand 14 restenotic) underwent treatment with angioplasty/stenting (groupA,n529; 43lesions) or SilverHawk atherectomy (group B, n511; 13 lesions). One filter was used perpatient (25 SpiderFX and 15 EmboShield). Macroembolization occurred in 22 (55.0%)patients, 11 (37.9%) in group A and 11 (100%) in group B (p,0.001). Clinically significant($2 mm in diameter) macrodebris was found in 18 (45.0%) patients: 8 (27.6%) in group Aand 10 (90.9%) in group B (p,0.001). All filters were retrieved successfully with nocomplications. One side-branch embolization occurred proximal to the filter. In anothercase, the filter was overfilled, resulting in no distal flow; it was retrieved, with subsequenttibial embolization when the procedure was continued without protection.Conclusion: Macroembolization is very frequent in patients undergoing lower extremityinterventions, particularly with SilverHawk atherectomy. EFP appears to be very effective incapturing macrodebris, and its use is associated with good acute angiographic outcome.The clinical significance of these findings needs to be determined in future studies.J Endovasc Ther 2008;15:270–276Key words: peripheral angioplasty, embolization, embolic filter protection, atherectomy,stent
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