Assessing Vascular Surgery Options In Patients With PAD

Lauren A. Fisher, DPM, Hillarie L. Sizemore, DPM, and Khurram H. Khan, DPM

A Pertinent Review Of The Current Literature
Clinical results using the SilverHawk have been encouraging but information regarding post-op outcomes of more than two years is scarce.
In a 2004 study, vascular surgeons used a stainless steel cutting blade and an 8 Fr vascular sheath to remove atherosclerotic plaque from porcine and human cases. The study reported a decrease in pretreatment diameter stenosis from 75 percent to 23.7 percent in patients.21
Zeller, et al., reported that six months after atherectomy, more than 80 percent of all patients were symptom free or had no lifestyle limiting claudication, and patients’ ABIs were significantly improved in primary lesions from an average of 0.57 to 0.72.22 Another study by Zeller reported a six-month restenosis rate of 22 percent and a six-month patency rate of 94.1 percent.23
A 2006 study by Kandzari, et al., focused on patients with critical limb ischemia and cases in which amputation had been the planned procedure. These authors found that using the SilverHawk prevented more extensive amputation or avoided it altogether in 82 percent of limbs at six-month follow-up.24
Yancy, et al., assessed the use of the SilverHawk system for limb salvage in patients with TASC C lesions (defined as a single stenosis or occlusion of > 5 cm or multiple stenoses or occlusions, each 3 to 5 cm with or without heavy calcification) and critical limb ischemia. Although the early data was promising, the study authors noted that ABIs at the six-month follow-up had returned to baseline levels. At the 12-month follow-up, only 22 percent of patients remained free of restenosis.25
The authors attribute the high incidence of recurrent symptoms and restenosis to the fact that their particular subset of patients had multilevel occlusive inflow or runoff disease that resulted in true critical limb ischemia.25
The largest study to date was with the Fox Hollow Corporation’s TALON registry, an observational, consecutive, non-randomized, multicenter registry.10
Vascular surgeons treated more than 601 patients with 1,258 symptomatic lower extremity lesions with the SilverHawk. Prior to intervention, 14.6 percent of the lesions produced ischemic symptoms that were classified as 5 or greater on the Rutherford scale, 26.8 percent of the lesions were occlusions and the mean percent diameter stenosis was 85.6 percent in patients with stand-alone plaque excision.10
After plaque excision, 97.6 percent of patients had less than 50 percent residual diameter stenosis and the mean percent diameter stenosis decreased to 10.5 percent (from 85.6 percent) for stand-alone plaque excision.10 Plaque excision improved the mean ABI from 0.70 to 0.85 at six months and 0.05 at 12 months. The study authors suggest this supports plaque excision as a primary endovascular therapy for patients undergoing lower extremity arterial revascularization.10
In 2007, Zeller, et al., reported two-year follow-up outcomes in patients who had undergone atherectomy of below-the-knee arterial lesions with the Silverhawk device for critically ischemic limbs that the authors classified as a Rutherford 4 or 5. Treatment decreased the average stenosis from 89 percent to 12 percent and the mean ABI increased from 0.48 to 0.81.26 Restenosis rates after 12 and 24 months were 33 and 40 percent respectively. At long-term follow-up, the mean ABI remained significantly improved at 0.72 after 12 months and 0.86 after 24 months.26

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