Periprocedural Complications With the Silverhawk Device: Is Endovascular Catheter Based Excision Safe?

Periprocedural complications with the Silverhawk device: Is endovascular catheter based excision safe?
Oropallo AR, Shaw P, Dhadly M, Farber A, Collins KA, Gibbons, GW
Introduction and Objectives: To examine the safety of catheter-based plaque excision using Silverhawk device as an alternative to surgery, angioplasty, and/or stenting in patients with limb ischemia
Methods: Between October 2003 and April 2006, a retrospective review of forty patients (70% men; mean age 71.8 years) with TASC A-D were treated at single institution using the Foxhollow Silverhawk device. Target lesions above the knee were 51.4% (n=36) and below the knee were 48.6% (n=34). Single lesions were involved 47.5% (n=19). Native vessels were involved 95.0% (n= 38) and bypass grafts 5% (n=2).
Results: Procedural success was obtained in 97.5% (n=39) with one failure to remove plaque after device insertion. Adjunctive procedures were performed 32.5% (n=13); angioplasty 27.5% (n=11) and stent placement 12.5% (n=5) to provide an angiographic result <= 50% stenosis and/or hemodynamically insignificant stenosis by pressure measurements across lesions (MAP < 10mmHg). Mean number of passes per vessel 6.1 (+/- 2.6) were performed with device LS 37.5% (n=18), MS 25.0% (n=12), SS 27.1% (n=13), and ES 10.4% (n=5). Mean number of devices used per case 1.2 (n=48). No major complications of myocardial ischemia, perforations, requirement of emergent surgery, death; maldeployment or defectiveness of the device were noted. Angiographic distal embolizations occurred 12.5% (n=5; 95% CI: 0.02-0.23). Successful treatment of all distal embolizations was performed using suction thromboembolectomy catheter.
Conclusions: We conclude that the Foxhollow Silverhawk device is a relatively safe device for the endovascular treatment of infrainguinal peripheral vascular disease. Angiographic distal embolizations can occur during plaque excision. However, the significance of distal embolizations warrants further evaluation as does the role of the procedure and its cost effectiveness in the management of peripheral vascular disease.