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, MN) and 513 patients/ 749 interventions performed without EPDs. TASC classification, run-off scores and embolic events were analyzed. End-points were morbidity, mortality, re-intervention, patency and major amputation rates.
Results
Both groups had similar demographics, indications, cardiovascular risk factors and run-off scores, but patients treated with EPDs had significantly (P<0.05) longer lesions (109±94 vs 85±76mm) 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 2 (2%) performed with EPD and 33 (4%) without EPD (P=0.35). Macroscopic debris was noted in 59 (68%) filter baskets. Embolic events were not associated with lesion length, TASC classification, run-off scores, treatment type or indication, but were independently associated with occlusion. Patients who had embolization required more re-interventions (20% vs 3%, P<.001) and major amputations at 30-days (11% vs 3%, P=0.02). There was no difference in hospital stay (2.4±4 vs 1.6±2 days, P=0.08), re-intervention (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 re-intervention. Most emboli were successfully treated by catheter aspiration or thrombolysis, but 8 patients (24%) treated without EPD required prolonged hospital stay, 7 (21%) had multiple re-interventions, 1 (3%) had unanticipated major amputation, and 1 (3%) died from hemorrhagic complications of thrombolysis. Median follow up was 20 months. At 2-years, primary patency and freedom for re-intervention 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 require multiple re-interventions in 21% or resulted in major amputation or death in 3%. Late outcomes were similar in patients treated with or without EPDs.