title: Plaque excision with the Silverhawk catheter: early results in patients with claudication or critical limb ischemia.
abstract: OBJECTIVE
  This study was conducted to detail the early experience after infrainguinal atherectomy using the Silverhawk plaque excision catheter for the treatment of symptomatic peripheral vascular disease.
  
  
  METHODS
  A prospective database was established in August 2004 in which data for operations, outcomes, and follow-up were recorded for patients undergoing percutaneous plaque excision for peripheral arterial occlusive disease. Society for Vascular Surgery (SVS) ischemia scores and femoropopliteal TransAtlantic Inter-Society Consensus (TASC) criteria were assigned. A follow-up protocol included duplex ultrasound surveillance at 1, 3, and 6 months and then yearly thereafter. Standard statistical analyses were performed.
  
  
  RESULTS
  During a 17-month period, 66 limbs of 60 patients (37 men [61.7%]) underwent 70 plaque excisions (four repeat procedures). Indications included tissue loss based on SVS ischemia at grades 5 and 6 (25/70), rest pain at grade 4 (22/70), and claudication at grades 2 to 3 (23/70). The mean lesion length was 8.8 +/- 0.7 cm. The technical success rate was 87.1% (61/70). Adjunctive treatment was required in 17 procedures (24.3%), consisting of 14 balloon angioplasties and three stents. Femoropopliteal TASC criteria included 5 TASC A lesions, 14 TASC B lesions, 32 TASC C lesions, and 19 TASC D lesions. Although 17 plaque excisions included a tibial vessel, no patient underwent isolated tibial atherectomy. The mean increase in ankle-brachial index was 0.27 +/- 0.04 and in toe pressure, 20.3 +/- 6.9 mm Hg. Mean duplex ultrasound follow-up was 5.2 months (range, 1 to 17 months). One-year primary, primary assisted, and secondary patency was 61.7%, 64.1%, and 76.4%, respectively. Restenosis or occlusion developed in 12 patients (16.7%) and was detected at a mean of 2.8 +/- 0.7 months. Restenosis or occlusion was significantly more common (P < .05) in patients with TASC C and D lesions compared with patients with TASC A and B lesions. Six (8.3%) of 12 patients underwent reintervention on the basis of duplex ultrasound surveillance results. Four (33.3%) of 12 patients experienced reocclusion during the same hospitalization, and amputation and open revascularization were required in two patients each.
  
  
  CONCLUSIONS
  Percutaneous plaque excision is a viable treatment option for lower extremity revascularization. Outcomes are related to ischemia and lesion severity. Patency and limb salvage rates are equivalent to other endovascular modalities.
authors.affiliation: Division of Vascular and Endovascular Surgery, University of South Florida,Tampa, FL, USA.
authors.forename: W Brent
authors.initials: WB
authors.lastname: Keeling
authors.forename: Murray L
authors.initials: ML
authors.lastname: Shames
authors.forename: Patrick A
authors.initials: PA
authors.lastname: Stone
authors.forename: Paul A
authors.initials: PA
authors.lastname: Armstrong
authors.forename: Brad L
authors.initials: BL
authors.lastname: Johnson
authors.forename: Martin R
authors.initials: MR
authors.lastname: Back
authors.forename: Dennis F
authors.initials: DF
authors.lastname: Bandyk
mesh_terms: D002406:Catheterization, Peripheral / Q000295:instrumentation*; D004867:Equipment Design; D005260:Female; D005263:Femoral Artery / Q000000981:diagnostic imaging / Q000601:surgery*; D005500:Follow-Up Studies; D006801:Humans; D007383:Intermittent Claudication / Q000000981:diagnostic imaging / Q000601:surgery*; D007511:Ischemia / Q000000981:diagnostic imaging / Q000601:surgery*; D007866:Leg / Q000098:blood supply*; D008297:Male; D011150:Popliteal Artery / Q000000981:diagnostic imaging / Q000601:surgery*; D011446:Prospective Studies; D012720:Severity of Illness Index; D016896:Treatment Outcome; D018616:Ultrasonography, Doppler, Duplex; D014656:Vascular Surgical Procedures / Q000379:methods*