Plaque Excision

Plaque Excision: A Novel Treatment Strategy for “Real World” Superficial Femoral Artery Disease. A 10-Month Clinical Experience with 6-Month Angiographic Follow-up

David E. Allie, Mitchell D. Lirtzman, Charles H. Wyatt, V. Antoine Keller, Mohamed H. Khan, Muhammad A. Khan, Peter S. Fail, Chris J. Hebert, Sonja D. Ellis, Elena Mitran, Gary Chaisson, Samuel Stagg, Jr., Adam A. Allie, Joseph M. Kowalski, Michael W. McElderry, Craig M. Walker
Cardiovascular Institute of the South, Lafayette, Opelousas & Houma, Louisiana

Background: High superficial femoral artery (SFA) restenosis rates ( > 30-40% at 1-2 year) exist irregardless of treatment with percutaneous transcatheter angioplasty (PTA), laser, rotational atherectomy or stenting. Recent disappointing brachytherapy and drug-eluting stent results and concerns regarding stent fractures have made novel SFA treatment strategies attractive options in the treatment of “Real World” TransAtlantic Inter-Societal Consensus (TASC) B and C lesions and in-stent restenosis (ISR). The SilverHawk atherectomy catheter (FoxHollow Technologies, Menlo Park, CA) is a novel device allowing simultaneous plaque excision with a carbide cutter and plaque retrieval using a distal nosecone collection chamber.

Methods: Between September 1, 2003 and June 1, 2004 133 SFA lesions [TASC B = 60/133 (45.1%), TASC C = 34/133 (25.6%), ISR = 39/133 (29.3%)] were treated with plaque excision (PE) [sole therapy = 119/133 (89.7%), PE/PTA = 5/133 (3.7%), PE/PTA/stent = 9/133 (6.7%)]. 12/14 (85.7%) of the PE/PTA/stent group occurred in TASC C lesions. All patients received periprocedural bivalirudin and 131/133 (98.4%) IIb/IIIa agents. Follow-up (FU) included baseline and 6-month ankle brachial index (ABI), duplex ultrasound (DU) and clinical exam. 64/133 (48.1%) had 6-month objective FU with DU = 64/64 (100%) and 52/64 (81.2%) with angiography [digital subtraction angiography (DSA) = 10/64 (15.6%), and 16-channel multi-detector CT angiography (CTA) = 42/64 (65.6%)].

Results: Procedural success = 131/133 (98.4%); mean lesional length = 16.2 cm (range 4-33 cm); ABI pre (0.61 ± 0.12) and post (0.79 ± 0.11); and 6-month overall angiography restenosis ( > 50%) = 5/52 (9.6%). There were no device related complications, embolic events or thrombosis. Lesion subject analysis (Table).

Conclusion: Plaque excision with the “SilverHawk” device is a safe, feasible, and efficient treatment for SFA TASC B, C, and ISR disease. These encouraging short-term results may allow clinicians to avoid the negative effects of barotrauma and allow for more selective stenting for SFA disease.