Plaque Excision Below-the-Knee

Plaque Excision Below-the-Knee: Preliminary Findings from A Single Center Prospective SilverHawk Registry

R. Stefan Kiesz, Robert G. Szewc, Thomas Ybarra, John Davis, John B. Simpson

Background: Patients with severe runoff vessel disease are at highest risk of limb loss. Thus far, surgical or percutaneous attempts of below-the-knee revascularization have been disappointing. SilverHawk is a novel device for plaque excision without the element of barotrauma. A prospective registry of patients with critical limb ischemia and severe runoff vessel disease was established.

Methods: To date, 38 patients have been treated. Forty-five percent were males, with a mean age of 65. Ninety percent were diabetics, 81% were smokers, 43% had previous MI or CABG and 28% had previous peripheral intervention. All patients had disabling claudication and 53% had Rutherford/Becker scores ≥ 5. Stand alone plaque excision was performed in 90.4% of cases, with adjunctive therapy PTA used in 9.6%. No stents were needed post-treatment with SilverHawk.

Results: SilverHawk was used in 136 lesions in the following vessels: 23 popliteal arteries, 21 peroneal or tibioperoneal trunk, 4 dorsalis pedis, 48 superficial femoral, 2 common femoral; one iliac and 1 femoropopliteal graft. Total occlusions accounted for 26.5% of lesions treated. No death, MI, stroke, or emergent surgery occurred. There was one minor perforation, which resolved with prolonged balloon inflation. All patients experienced relief of symptoms, and all but one became ambulatory. One patient previously scheduled for an above-knee amputation underwent a below-knee amputation one month post procedure due to pre-existing osteomyelitis.

Conclusions: Early experience demonstrates the safety and efficacy of the SilverHawk Plaque Excision System in treatment of severe runoff vessel disease with encouraging clinical outcomes.