title: Revascularization for critical limb ischemia using the SpiderFX embolic protection device in the below-the-knee circulation: initial results.
abstract: OBJECTIVE
  To 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).
  
  
  METHODS
  A 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.
  
  
  RESULTS
  The 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.
  
  
  CONCLUSIONS
  The use of the SpiderFX EPD in the BTK circulation in patients with CLI is safe and frequently retrieves debris.
authors.affiliation: Department of Interventional Radiology, Mount Sinai Medical Center, One Gustave L. Levy Pl., Box 1234, New York, NY 10029.
authors.forename: Thomas J
authors.initials: TJ
authors.lastname: Ward
authors.affiliation: Department of Interventional Radiology, Mount Sinai Medical Center, One Gustave L. Levy Pl., Box 1234, New York, NY 10029.
authors.forename: Rachel L
authors.initials: RL
authors.lastname: Piechowiak
authors.affiliation: Department of Interventional Radiology, Mount Sinai Medical Center, One Gustave L. Levy Pl., Box 1234, New York, NY 10029.
authors.forename: Rahul S
authors.initials: RS
authors.lastname: Patel
authors.affiliation: Department of Interventional Radiology, Mount Sinai Medical Center, One Gustave L. Levy Pl., Box 1234, New York, NY 10029.
authors.forename: Aaron M
authors.initials: AM
authors.lastname: Fischman
authors.affiliation: Department of Interventional Radiology, Mount Sinai Medical Center, One Gustave L. Levy Pl., Box 1234, New York, NY 10029.
authors.forename: F Scott
authors.initials: FS
authors.lastname: Nowakowski
authors.affiliation: Department of Interventional Radiology, Mount Sinai Medical Center, One Gustave L. Levy Pl., Box 1234, New York, NY 10029.
authors.forename: Edward
authors.initials: E
authors.lastname: Kim
authors.affiliation: Department of Vascular Surgery, Mount Sinai Medical Center, One Gustave L. Levy Pl., Box 1234, New York, NY 10029.
authors.forename: Sharif H
authors.initials: SH
authors.lastname: Ellozy
authors.affiliation: Department of Vascular Surgery, Mount Sinai Medical Center, One Gustave L. Levy Pl., Box 1234, New York, NY 10029.
authors.forename: Peter L
authors.initials: PL
authors.lastname: Faries
authors.affiliation: Department of Interventional Radiology, Mount Sinai Medical Center, One Gustave L. Levy Pl., Box 1234, New York, NY 10029. Electronic address: robert.lookstein@mountsinai.org.
authors.forename: Robert A
authors.initials: RA
authors.lastname: Lookstein
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000671:Amputation, Surgical; D016638:Critical Illness; D057505:Embolic Protection Devices; D004617:Embolism / Q000209:etiology / Q000517:prevention & control*; D057510:Endovascular Procedures / Q000009:adverse effects / Q000295:instrumentation*; D005260:Female; D006801:Humans; D007511:Ischemia / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D007866:Leg / Q000098:blood supply*; D023821:Limb Salvage; D008297:Male; D008875:Middle Aged; D009519:New York City; D011474:Prosthesis Design; D012039:Regional Blood Flow; D019233:Retreatment; D012189:Retrospective Studies; D012307:Risk Factors; D017131:Thrombectomy; D015912:Thrombolytic Therapy; D013997:Time Factors; D016896:Treatment Outcome