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Hoffmann, R. A wiki for the life sciences where authorship matters. Nature Genetics (2008)
 
 
 

Distal filter protection during saphenous vein graft stenting: technical and clinical correlates of efficacy.

OBJECTIVES: The aim of this study was to evaluate the clinical, angiographic, and technical factors related to successful stenting of diseased saphenous vein grafts (SVGs) using a novel filter-based distal protection device. BACKGROUND: Protection of the distal microvasculature with a balloon occlusion and aspiration system has been shown to reduce atherothrombotic embolization and peri-procedural myocardial infarction (MI) after percutaneous coronary intervention (PCI) in SVGs. The safety, efficacy, and technical factors relating to procedural success with filter-based distal protection devices are unknown. METHODS: Percutaneous coronary intervention was performed in 60 lesions in 48 patients undergoing SVG intervention with the FilterWire EX distal protection system in a phase I experience at six sites. A larger phase II study was then performed in 248 lesions in 230 SVGs at 65 U.S. centers. RESULTS: Cumulative adverse events to 30 days occurred in 21.3% of patients in phase I, including a 19.1% rate of MI. Numerous anatomic, device-specific, and operator-related contributors to these adverse events were identified, resulting in significant changes to the protocol and instructions for use. Subsequently, despite similar clinical and angiographic characteristics to the phase I patients, the 30-day adverse event rate in phase II was reduced to 11.3% (p = 0.09), due primarily to a lower incidence of peri-procedural Q-wave and non-Q-wave MI. CONCLUSIONS: Distal protection during SVG PCI with the FilterWire EX is associated with a low rate of peri-procedural adverse events compared to historical controls. A unique set of anatomic, technical, and operator-related issues exist with distal filters which, if ignored, may reduce their effectiveness.[1]

References

  1. Distal filter protection during saphenous vein graft stenting: technical and clinical correlates of efficacy. Stone, G.W., Rogers, C., Ramee, S., White, C., Kuntz, R.E., Popma, J.J., George, J., Almany, S., Bailey, S. J. Am. Coll. Cardiol. (2002) [Pubmed]
 
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