Revascularization for critical limb ischemia using the SpiderFX embolic protection device in the below-the-knee circulation: initial results.

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.