Dethrombosis of the lower extremity arteries using the power-pulse spray technique in patients with recent onset thrombotic occlusions: results of the DETHROMBOSIS Registry.

PURPOSE: To assess the presence of thrombus using intravascular ultrasound (IVUS) and evaluate the feasibility of combined thrombolysis [power-pulse spray (P-PS)] and rheolytic thrombectomy (RT) in patients with recent-onset limb ischemia (<6 months) due to total occlusion of at least 1 infrainguinal vessel. METHODS: Seventeen patients (12 women; mean age 68.3+/-10.7 years) enrolled in a prospective registry underwent IVUS imaging at baseline, after treatment with P-PS using tissue plasminogen activator and RT (AngioJet), and prior to definitive treatment of the vessel. The primary safety endpoints were major bleeding, distal embolization, vascular access complications, and renal failure. Effectiveness outcomes were (1) procedural success with a residual stenosis <30%, (2) IVUS-documented resolution of the thrombus, and (3) the combined clinical endpoint of procedure-related death, stroke, unplanned amputation, and unplanned urgent revascularization of the treated limb. RESULTS: At baseline, the majority of patients (16, 94.1%) had a definite thrombus identified by IVUS; in the remaining patient (6.3%), thrombus was likely to be present according to the IVUS scan. By angiography, 2 (11.8%) patients had a definite grade 3 thrombus and 5 (29.4%) patients had a grade 1 thrombus (modified TIMI scale) at baseline. IVUS data were available pre and post P-PS/RT in 16 (94.1%) patients. In 10 (62.5%), the thrombus was partially resolved; in 5 (31.25%), there was no apparent change. The thrombus appeared to have completely resolved in only 1 (6.3%) patient. Embolization occurred in 3 (17.6%) patients with no adverse clinical sequelae. The combined clinical endpoint was met in 1 (5.9%) of 17 patients. After final definitive treatment of the vessel, acute procedural success was 100%, with no angiographic filling defects seen. CONCLUSION: Thrombus is present in most if not all patients with a recent history of limb ischemia who are found to have an occluded culprit vessel. The application of the P-PS/RT led to partial or complete thrombus resolution in about two thirds of the patients treated. The overall safety outcome was favorable, but large studies are needed to test the effectiveness of the P-PS/RT technique prior to routine use.