TY - JOUR
T1 - Revascularization for critical limb ischemia using the SpiderFX embolic protection device in the below-The-Knee circulation
T2 - Initial results
AU - Ward, Thomas J.
AU - Piechowiak, Rachel L.
AU - Patel, Rahul S.
AU - Fischman, Aaron M.
AU - Nowakowski, F. Scott
AU - Kim, Edward
AU - Ellozy, Sharif H.
AU - Faries, Peter L.
AU - Lookstein, Robert A.
N1 - Publisher Copyright:
© 2014 SIR.
PY - 2014/10/1
Y1 - 2014/10/1
N2 - Purpose 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).Materials and 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.
AB - Purpose 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).Materials and 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.
UR - http://www.scopus.com/inward/record.url?scp=84908139800&partnerID=8YFLogxK
U2 - 10.1016/j.jvir.2014.07.016
DO - 10.1016/j.jvir.2014.07.016
M3 - Article
C2 - 25156826
AN - SCOPUS:84908139800
SN - 1051-0443
VL - 25
SP - 1533
EP - 1538
JO - Journal of Vascular and Interventional Radiology
JF - Journal of Vascular and Interventional Radiology
IS - 10
ER -