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Revascularization for Critical Limb Ischemia Using the SpiderFX Embolic Protection Device in the Below-the-Knee Circulation: Initial Results
Affiliation:1. Department of Interventional Radiology, Mount Sinai Medical Center, One Gustave L. Levy Pl., Box 1234, New York, NY 10029;2. Department of Vascular Surgery, Mount Sinai Medical Center, One Gustave L. Levy Pl., Box 1234, New York, NY 10029;1. Department of Radiology, Stanford University Medical Center, 725 Welch Road, Room 1690 MC 5913, Palo Alto, CA 94304;2. Centers for Disease Control and Prevention, Atlanta, Georgia;3. Interventional Radiology Translational Research Laboratory, Department of Radiology, Duke University Medical Center, Durham, North Carolina.;1. Department of Radiology, Okayama University Medical School, 2-5-1 Shikatacho, Kita-ku, Okayama 700-8558, Japan;2. Department of Gastroenterological Surgery, Okayama University Medical School, 2-5-1 Shikatacho, Kita-ku, Okayama 700-8558, Japan;3. Department of General Thoracic Surgery, Okayama University Medical School, 2-5-1 Shikatacho, Kita-ku, Okayama 700-8558, Japan;1. Department of Radiology, University of Wisconsin School of Medicine and Public Health, E3/311 Clinical Sciences Center, 600 Highland Ave., Madison, WI 53792;2. Department of Biomedical Engineering, University of Wisconsin School of Medicine and Public Health, E3/311 Clinical Sciences Center, 600 Highland Ave., Madison, WI 53792;3. Department of Medical Physics, University of Wisconsin School of Medicine and Public Health, E3/311 Clinical Sciences Center, 600 Highland Ave., Madison, WI 53792;1. Division of Interventional Radiology, Massachusetts General Hospital, Harvard Medical School, 55 Fruit Street, 290 Gray/Bigelow, Boston, MA 02114.;2. Division of Molecular Pathology, Massachusetts General Hospital, Harvard Medical School, 55 Fruit Street, 290 Gray/Bigelow, Boston, MA 02114.;3. Division of Hematology/Oncology, Center for Liver Cancer, Massachusetts General Hospital, Harvard Medical School, 55 Fruit Street, 290 Gray/Bigelow, Boston, MA 02114.;1. Mallinckrodt Institute of Radiology, Washington University School of Medicine, 510 S. Kingshighway Blvd., St. Louis, MO 63110;2. Department of Radiology, Mayo Clinic, Jacksonville, Florida
Abstract:PurposeTo examine the safety and efficacy of the SpiderFX embolic protection device (EPD) in the below-the-knee (BTK) circulation in patients with critical limb ischemia (CLI).Materials and MethodsA single-center retrospective review was performed to identify patients with CLI and single-vessel runoff in whom the SpiderFX EPD was used in the BTK circulation. Technical success and device-related complications were the primary endpoints. Retrieval of macroscopic debris in the EPD, 1-year freedom from major adverse limb events (MALEs), and 30-day perioperative death were also evaluated. A major amputation, surgical bypass, endovascular thrombectomy, or endovascular thrombolysis was considered a MALE. Thirty-six patients (21 men; mean age, 75.8 y) treated between 2008 and 2013 had endovascular revascularization with use of the SpiderFX EPD in the BTK circulation.ResultsThe SpiderFX EPD was successfully deployed in all cases; the technical success rate of revascularization was 100%. Two minor and zero major complications were observed related to the SpiderFX. Two MALEs, a major amputation and a subsequent surgical bypass, were observed in the cohort. All MALEs occurred within 1 year of treatment (1-y freedom from MALE rate, 90%). Debris was retrieved in the SpiderFX device in 47% of patients.ConclusionsThe use of the SpiderFX EPD in the BTK circulation in patients with CLI is safe and frequently retrieves debris.
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