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Objective: The purpose of this study was to evaluate the incidence, predictive factors 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 with 836 femoropopliteal endovascular interventions for lower extremity claudication (46%) or critical limb ischemia (54%) from 2002 to 2012. Outcomes were analyzed in 74 patients/ 87 interventions treated with EPDs (Spider Rx, Covidien, Plymouth, MN) and 513 patients/ 749 interventions treated without EPDs. TASC classification, run-off scores and embolic events were analyzed by an independent investigator using conventional angiography. Univariate and multivariate logistic regression analysis was performed to identify predictors of embolization. End-points were presence of embolization, length of stay, re-intervention 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 TASC C/D lesions (56% vs 30%) or occlusions (64% vs 30%). Embolic events occurred in 35/836 (4%) interventions, including 2 (2%) performed with 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 or lack of anti-platelet therapy (P<0.05). 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. Most embolic events were successfully treated at the initial procedure by catheter aspiration or thrombolysis, but 8 patients (24%) treated without EPD required prolonged hospital stay, 7 (21%) had multiple re-interventions and 1 (3%) had unanticipated major amputation due to embolization.
Conclusions: Clinically significant embolic events are uncommon after femoropopliteal interventions, but two thirds of patients have evidence of microembolization. Emboli are more frequent in patients with occlusions and in those not taking anti-platelet therapy. One in four patients who developed embolization without EPD require escalating level of care, indicating that EPDs may reduce the clinical significance of embolic events.