Initial clinical experience with distal embolic protection using "Filtrap", a novel filter device with a self-expandable spiral basket in patients undergoing percutaneous coronary intervention.

We developed a new filter-type distal protection guide wire, Filtrap, that uses a polyurethane filter with 1834 100-μm micropores covering the distal half of a spindle-shaped spiral Ni-Ti basket. The basket is 5 mm in diameter, self-expandable, and is mounted at the distal end of the system. This study aimed to assess the usefulness and safety of Filtrap during percutaneous coronary intervention (PCI). Early angiographic and in-hospital outcomes were reviewed in 14 patients, including 9 acute coronary syndrome patients, treated with Filtrap during PCI. All lesions were located in native coronary arteries but one was located in a saphenous vein graft. The Filtrap was successfully delivered and deployed distal to the lesion in 13 of 14 patients (93%). All PCI procedures including stent implantation were successfully completed except for 2 AMI patients, who ended up with Thrombolysis in Myocardial Infarction (TIMI) 2 coronary flow. One of these 2 patients had a distal embolization which occurred after thrombectomy before Filtrap insertion. The mean time of device insertion was 9.4 ± 3.2 min. Five patients showed transient no-reflow that was completely restored immediately with removal of the device. Embolic debris was entrapped in 8 (62%) of these cases. All patients were free from in-hospital events except for one patient with a large anterior acute myocardial infarction who received an emergency surgery due to a free wall cardiac rupture. These results suggest that the Filtrap is a practical and safe device for embolic protection during PCI.