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  • Title: Distal protection during primary angioplasty: a feasibility and safety study utilizing a novel filter technology.
    Author: Cura F, Albertal M, O'Neill W, Milei J, Padilla L, Perez Baliño P, Trivi M, Belardi J.
    Journal: J Invasive Cardiol; 2006 Oct; 18(10):442-5. PubMed ID: 17042098.
    Abstract:
    BACKGROUND: The degree of myocardial reperfusion after primary percutaneous coronary intervention (PCI) may be reduced by distal embolization. We tested the safety, feasibility and efficacy of a novel filter device, the Spider Distal Embolic Protection System, as an adjunct to primary PCI. METHODS AND RESULTS: Twenty consecutive patients undergoing primary PCI with the Spider Embolic Protection Device were included in the analysis. Successful Spider device positioning was obtained in all cases, with predilatation of the lesions in 1 of these cases (5%). There were no procedural complications attributable to the use of a filter. Histological analysis of the content of 5 filters showed multiple embolic debris in all cases, from 8 to 48 particles per filter, from 101-1,299 mm in diameter and from 212-1,487 mm2 in area. The use of the Spider filter was associated with a profound ST-segment resolution (STR: 85.6 +/- 16.5%) and the occurrence of complete (50%) STR of 90%. CONCLUSIONS: The Spider Embolic Protection Device as an adjunctive therapy during primary PCI is feasible and safe, preventing distal embolization and improving myocardial reperfusion. Currently, an international, multicenter, randomized clinical trial is prospectively testing this challenging hypothesis.
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