Purpose: To report the results from a single-center prospective registry (DEEP EMBOLI) established to evaluate distal embolization during percutaneous lower extremity interventions using excimer laser ablative therapy.
Methods: Elective patients with infrainguinal occlusive disease were eligible for this registry if the lesion(s) met one or more of these angiographic criteria: (1) moderate or severe calcification 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-ulcerated lesions at least 50 mm in length. In all, 20 patients (15 women; mean age 70.9+/-10.8 years) with 28 lesions (de novo 13, restenotic 15) were enrolled and underwent treatment with laser atherectomy. SpiderFx filters were utilized before laser treatment in 18 of 20 patients and before final definitive treatment with angioplasty +/- stenting in all 20 patients. The primary angiographic outcome was a residual narrowing of <30% or 30% to 50% with <20 mmHg gradient across lesion after final treatment. The primary safety endpoint was the embolization rate produced by the laser based on the presence of clinically significant (>or=2 mm long) macrodebris in the filter.
Results: Adjunctive angioplasty and stenting were performed in 27 (96.4%) and 17 (60.7%) lesions, respectively. All filters were deployed and retrieved successfully, with no complications. The primary angiographic endpoint was met in 100% of patients. Macrodebris was found in 12 (66.7%) of 18 patients after treatment with the laser [4 (22.2%) filters with clinically significant emboli] and in 7 (35%) of 20 patients after adjunctive treatment [4 (20.0%) clinically significant emboli]. One (5.0%) distal embolization occurred after filter removal prior to completion of definitive treatment.
Conclusion: Embolization does occur with laser photoablation in the lower extremity, but the rate of clinically significant macrodebris is low ( approximately 20%) and similar to that found after angioplasty and stenting. Embolic filter protection appears to be very effective in capturing macrodebris, and its use is associated with good acute angiographic outcome. Problems with filter retrieval were not encountered.