Can Endovascular Atherectomy Be Beneficial In Diabetic Limb Salvage?

By Peter Wilusz, DPM, and Guy Pupp, DPM

What The Research Reveals About The Endovascular Atherectomy

Many study models have investigated the longer-term results of the Silverhawk procedure. The TALON study is a national registry which tracks outcomes after treatment with the Silverhawk system, and has over 506 patients and 1,099 lesions enrolled to date.9 Thirty-two percent of the patients had critical limb ischemia with ABIs below 0.6. Minimal lumen diameter improved from 1.6 mm pre-procedure to 4.5 mm post-procedure and the diameter stenosis improved from 87.1 percent to 9.9 percent. The mean pre-surgical ABI was 0.61 + 0.12 and improved to a post-op ABI of 0.79 + 0.11. The overall patency rate at six months was 90.4 percent.9      The Arizona Heart Hospital 12-month outcomes data involved 181 patients and 202 limbs.10 The mean ABI increase was 0.27. Ninety-two patients (45.5 percent) of patients completed the six-month follow up, resulting in a primary patency rate of 96 percent.10 More recently, researchers reported an 86 patency rate at 12 months for 104 patients with peripheral vascular disease treated with Silverhawk. These findings are encouraging evidence that the Silverhawk system also provides good long-term benefit.      The Cardiovascular Institute of the South conducted a six-month follow-up study investigating the rate of restenosis following the Silverhawk procedure.11 From Sept. 2, 2003 to June 1, 2004, researchers treated 133 superficial femoral artery lesions (64 patients) with the Silverhawk system. At six months, they examined all 64 patients with Duplex ultrasound and examined 42 (65 percent) of the patients via CT angiogram (CTA). Using the Duplex ultrasound, investigators observed a 9.4 percent (6 of 64) restenosis rate, which was very close to the 9.6 percent (5 of 42) restenosis rate observed with CTA.

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