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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

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Abstract

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.

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Acknowledgments

Nipro provided financial support for the histopathologic analyses.

Conflict of interest

Dr. Isshiki has received royalties, consulting fees, and honoraria from Nipro and holds Nipro company stock. Dr. Kozuma has received consulting fees and honoraria from Nipro. The other authors report no conflicts of interest.

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Authors and Affiliations

  1. Division of Cardiology, Department of Internal Medicine, Teikyo University School of Medicine, 2-11-1 Kaga, Itabashi-ku, Tokyo, 173-8606, Japan

    Takaaki Isshiki, Ken Kozuma, Hiroyuki Kyono, Nobuaki Suzuki & Naoyuki Yokoyama

  2. Department of Cardiology, Iwaki Kyoritsu General Hospital, Iwaki, Japan

    Yoshito Yamamoto

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  1. Takaaki Isshiki
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  2. Ken Kozuma
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  3. Hiroyuki Kyono
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  4. Nobuaki Suzuki
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  5. Naoyuki Yokoyama
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  6. Yoshito Yamamoto
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Correspondence to Takaaki Isshiki.

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Isshiki, T., Kozuma, K., Kyono, H. et al. 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. Cardiovasc Interv and Ther 26, 12–17 (2011). https://doi.org/10.1007/s12928-010-0027-y

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  • DOI: https://doi.org/10.1007/s12928-010-0027-y

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