Revascularization for critical limb ischemia using the SpiderFX embolic protection device in the below-the-knee
Thomas J Ward1, Rachel L Piechowiak1, Rahul S Patel1
1Department of Interventional Radiology, Mount Sinai Medical Center, One Gustave L. Levy Pl., Box 1234, New York, NY 10029.
Insights
The SpiderFX embolic protection device (EPD) is safe and effective for below-the-knee (BTK) interventions in critical limb ischemia (CLI) patients, successfully retrieving debris in nearly half of cases.
Area of Science:
- Vascular Surgery
- Interventional Cardiology
- Medical Devices
Background:
- Critical limb ischemia (CLI) poses significant risks for limb loss.
- Below-the-knee (BTK) interventions are challenging due to small vessel size and runoff.
- Embolic protection devices (EPDs) aim to reduce complications during endovascular procedures.
Purpose of the Study:
- To evaluate the safety and efficacy of the SpiderFX EPD in BTK circulation for CLI patients.
- To assess technical success, device-related complications, and limb outcomes.
Main Methods:
- Retrospective review of 36 CLI patients undergoing BTK endovascular revascularization with SpiderFX EPD.
- Primary endpoints: technical success and device-related complications.
- Secondary endpoints: debris retrieval, 1-year freedom from major adverse limb events (MALEs), and 30-day mortality.
Main Results:
- 100% technical success for SpiderFX EPD deployment and revascularization.
- Zero major complications and two minor complications related to the device.
- 47% of patients had macroscopic debris retrieved in the EPD.
- 90% 1-year freedom from MALEs (major amputation, bypass, thrombectomy/thrombolysis).
Conclusions:
- SpiderFX EPD is safe for BTK interventions in CLI patients.
- The device effectively captures embolic debris during these procedures.
- Positive outcomes support the use of SpiderFX EPD in complex BTK revascularizations.
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.
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