Preferred Treatment

Is Plaque Excision the Preferred Treatment for Peripheral Arterial Disease?" Initial Experience with the FoxHollow SilverHawk Device

Roger Gammon, Atul Chopra, Mary Wetherill
Austin Heart, Austin, TX

Background: Previous modalities used to treat infra-inguinal peripheral arterial disease have had limited success due to high restenosis rates. SilverHawk plaque excision is fundamentally different from angioplasty/stenting as it achieves luminal gain through plaque removal instead of plaque displacement while avoiding significant barotrauma. This difference may reduce the risk of dissection while also altering the cellular signals that are responsible for the initiation of intimal hyperplasia.

Methods: 76 consecutive patients undergoing plaque excision for the treatment of lower extremity peripheral arterial disease (PAD) were included. Study endpoints include immediate procedural and angiographic outcomes and target lesion patency and revascularization at 6 and 12 months post-procedure.

Results: Plaque excision was performed in 76 patients and 157 lesions (table 1). 8% of the patients were treated for severe PAD (Rutherford-Becker scores ≥5). 75% of the lesions were above-the-knee and 25% were below-the-knee (table 2). 89% of the lesions were de novo and 11% were restenotic (3% ISR). 61% of lesions showed moderate-severe calcification. 15% of the lesions required pre-dilation. 45% of the procedures treated ≥2 lesions (table 3). Stand-alone plaque excision was used in 76%, adjunctive PTA was done in 24% and stents were placed in 2.5% of the lesions. Angiography showed a reduction in the average diameter stenosis from 86% to 15% in stand alone SilverHawk cases and 88% to 16% in cases utilizing adjunctive therapy. The post SilverHawk minor complication rate was 3.8% (due to minor dissection) and we did not observe any distal embolization, thrombosis, abrupt closures or re-occlusions.

Conclusions: SilverHawk plaque excision provides excellent immediate angiographic results in a challenging patient population, including calcified and multi-level disease. These data warrant further investigation into plaque excision, both clinically and at the cellular level. Intermediate and long term follow-up will be presented.