Clinical significance of embolic events in patients undergoing endovascular femoropopliteal interventions with or without embolic protection devices

Objective The purpose of this study was to evaluate the incidence and clinical significance of embolic events in patients undergoing endovascular femoropopliteal interventions with or without embolic protection devices (EPDs). Methods We reviewed the clinical data of 566 patients treated by 836 endovascular femoropopliteal interventions for lower extremity claudication (46%) or critical limb ischemia (54%) from 2002 to 2012. Outcomes were analyzed in 74 patients/87 interventions performed with EPDs (Spider Rx; Covidien, Plymouth, Minn) and 513 patients/749 interventions performed without EPDs. TransAtlantic Inter-Society Consensus (TASC) II classification, runoff scores, and embolic events were analyzed. End points were morbidity, mortality, reintervention, patency, and major amputation rates. Results Both groups had similar demographics, indications, cardiovascular risk factors, and runoff scores, but patients treated with EPDs had significantly (P <.05) longer lesions (109 ± 94 mm vs 85 ± 76 mm) and more often had occlusions (64% vs 30%) and TASC C/D lesions (56% vs 30%). Embolic events occurred in 35 of 836 interventions (4%), including two (2%) performed with EPD and 33 (4%) without EPD (P =.35). Macroscopic debris was noted in 59 (68%) filter baskets. Embolic events were not associated with lesion length, TASC classification, runoff scores, treatment type, or indication but were independently associated with occlusion. Patients who had embolization required more reinterventions (20% vs 3%; P <.001) and major amputations at 30 days (11% vs 3%; P =.02). There was no difference in hospital stay (2.4 ± 4 days vs 1.6 ± 2 days; P =.08), reintervention (2% vs 4%), and major amputation (1% vs 4%) among patients treated with or without EPD, respectively. The two patients who developed embolization with EPDs had no clinical sequela and required no reintervention. Most emboli were successfully treated by catheter aspiration or thrombolysis, but eight patients (24%) treated without EPD required prolonged hospital stay, seven (21%) had multiple reinterventions, one (3%) had unanticipated major amputation, and one (3%) died from hemorrhagic complications of thrombolysis. Median follow-up was 20 months. At 2 years, primary patency and freedom from reintervention was similar for TASC A/B and TASC C/D lesions treated with or without EPDs. Conclusions Rates of embolization are low in patients undergoing endovascular femoropopliteal interventions with (4%) or without (2%) EPD. Embolization is more frequent in patients with occlusions. While emboli in patients with EPD had no clinical sequel, those treated without EPD required multiple reinterventions in 21% or resulted in major amputation or death in 3%. Late outcomes were similar in patients treated with or without EPDs.