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Embolic Protection Devices Below The Knee For Critical Limb Ischemia Interventions: Initial Results
James Jen, MD1, Robert A. Lookstein, MD1, Sharif H. Ellozy, MD1, Michael L. Marin, MD1, Henry Jen, BA2, Peter L. Faries, MD1.
1Mount Sinai Hospital, New York, NY, USA, 2Stony Brook Medical School, Stony Brook, NY, USA.

OBJECTIVES: To assess the safety and efficacy of the use of a distal embolic protection device in below-the-knee vessels in patients with critical limb ischemia and single-vessel runoff.
METHODS: Retrospective review of 30 consecutive patients treated at a single institution over a 5 year period. All patients were Rutherford class 4-6 and had single-vessel runoff. The technical success rate, the target vessel, the level of disease, the runoff before and after the intervention, the nature of the intervention, complications related to the use of the filter, the incidence of macroscopic debris, complete occlusion of the filter and target vessel with debris, and limb salvage at 30 days were examined.
RESULTS: Technical success with delivery of the device to the runoff vessel and successful retrieval was 100%. The most common target vessel for the device was the peroneal artery 43.3% (n= 13), followed by the anterior tibial artery 40% (n=12) and the posterior tibial artery 16.7% (n=5). Multisegmental disease was treated in 76.7% of patients (n=23). Femoral-popliteal disease alone was treated in 13.3% (n=4) and tibial disease alone was treated in 10% (n=3). Single vessel runoff was demonstrated before and after the intervention in 100% of cases. Stenting was utilized in 80% (n=24) of interventions. Laser or rotational atherectomy was used in 16.7% (n=5). Pharmacomechanical thrombolysis was used in 23.3% (n=7). Acute occlusions comprised 10% (n=3). The only complication attributable to the embolic protection device was spasm which was seen in 6.7% (n=2) and in both cases resolved with use of vasodilators. Macroscopic debris was visualized on fluoroscopy in 53.3% (n=16). No reflow phenomena was seen in 13.3% (n=4) which resolved with removal of the filter. Limb salvage at 30 days was 100%.
CONCLUSIONS: The use of a distal embolic protection device in below-the-knee vessels is a safe method of protecting single vessel runoff in patients with critical limb ischemia. Technical success was achieved in all patients in each of the tibioperoneal vessels. Complex interventions involving multisegmental disease and a variety of techniques resulted in a majority of patients having fluoroscopically visualized debris in the filter with some patients having total occlusion of the filter prior to retrieval. Distal runoff was preserved in all cases and there was no limb loss in the short term.


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