Initial clinical experience with distal protection using the FilterWire in patients undergoing coronary artery and saphenous vein graft percutaneous intervention.
Percutaneous coronary intervention (PCI) of saphenous vein grafts (SVG) and native coronary arteries may be associated with embolization of particulate debris into the distal microcirculation. The FilterWire uses a polyurethane filter bag contained on a radiopaque loop to trap embolic debris during native vessel and SVG intervention. The objectives of this study were to assess the feasibility and safety of the FilterWire during PCI and to examine the size and content of the particulate debris captured during SVG and native vessel intervention. Early angiographic, in-hospital, and 30-day clinical outcomes were reviewed in 35 patients with 36 lesions treated with the FilterWire during PCI. Lesions were located in 22 (61%) native coronary arteries and in 14 (39%) SVGs. Multivessel coronary artery disease was present in 75% of patients. Lesions were complex (ACC/AHA complexity B2 or C) in 81% of cases. The FilterWire was successfully delivered and deployed distal to the site of coronary intervention in 92% of lesions, including 95% of native vessels and 82% of SVG lesions. Embolic debris was entrapped in 82% of these cases. The average particulate debris had a mean major axis of 490 microm (range, 45-3,302 microm) and minor axis of 226 microm (range, 33-1,677 microm). Although reduced flow was common (36.1%) when the FilterWire was in place, there were no sustained episodes of abrupt closure and only one (2.8%) patient developed sustained no-reflow after FilterWire removal. Distal branch vessel embolization was found in four (11.1%) cases. Major adverse cardiac events occurred in 5 (14%) of 35 patients treated with the device, although 2 of these patients were evolving an acute myocardial infarction at the time of the procedure; in patients meeting the prospectively defined inclusion criteria, the major adverse cardiac event was 6%. These results suggest that the FilterWire is a feasible and safe method of collecting particulate debris released during SVG and native vessel coronary intervention. Its benefit over conventional therapy and other distal protection devices is currently under study.
D000368:Aged; D003251:Constriction, Pathologic; D017023:Coronary Angiography; D001026:Coronary Artery Bypass; D003327:Coronary Disease / Q000601:surgery*; D004617:Embolism / Q000517:prevention & control*; D005240:Feasibility Studies; D005260:Female; D005374:Filtration / Q000295:instrumentation; D006083:Graft Occlusion, Vascular / Q000601:surgery*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010316:Particle Size; D012189:Retrospective Studies; D012501:Saphenous Vein / Q000637:transplantation*