Lee Goldstein, Syed Shah, James McKinsey, Elliot Sambol, Roman Nowygrod, K. Craig Kent, Nicholas J. Morrissey.
Columbia/Weill Cornell Division of Vascular Surgery, New York, N.Y.
OBJECTIVES: Percutaneous interventions of the superficial femoral artery (SFA) rely on manipulation of lesions with a variety of devices. Embolization during these interventions may result in distal ischemia. While distal protection has gained acceptance in coronary and carotid interventions, there is no consensus that lower extremity interventions require such devices. We expanded our previous experience with Doppler analysis of embolization during SFA intervention to determine clinical relevance as well as potential differences in rates of emboli between techniques.
METHODS: 96 patients undergoing SFA intervention were enrolled. A 4-MHz Doppler probe was used for continuous monitoring in the ipsilateral popliteal artery. Distal embolization was defined as microembolic signals (MES) detected by the probe. MES were quantified during portions of the procedures (percutaneous transluminal angioplasty (PTA), stent deployment, and Silverhawk atherectomy (SH)). Angiograms at completion were analyzed for distal embolization. Patients were followed for clinical outcome and change in ankle brachial index (ABI) after the intervention. Analysis of variance (ANOVA) and T- test were used to analyze the quantitative data.
RESULTS: In all cases embolization occurred during wire crossing and all interventions. One patient (1%) had loss of a runoff vessel that was successfully treated with thrombolysis. Ninety-five (99%) patients had clinical improvement defined as relief of claudication, rest pain or healing of wounds/minor amputations. The ABI increased by an average of 0.3. Tables 1 and 2 summarize rates of embolization for different classes of intervention.
CONCLUSIONS: Embolization occurred in all phases of all interventions, however clinical impact was negligible. The one case of significant embolization occurred in a patient with subacute thrombosis of a chronic lesion. While atherectomy caused more embolization per cm. treated than stenting, there were no differences in outcome. The higher rate of emboli during pre-stent dilation compared to post-dilation suggests that primary stenting without predilation may be a safer approach. These results suggest that distal protection is not indicated in routine SFA intervention but may be useful in cases where thrombosis is suspected.
AUTHOR DISCLOSURES: L. Goldstein, None; S. Shah, None; J. McKinsey, None; E. Sambol, None; R. Nowygrod, None; K.C. Kent, None; N.J. Morrissey, Boston Scientific.