title: Acute and long-term outcome of Silverhawk assisted atherectomy for femoro-popliteal lesions according the TASC II classification: a single-center experience.
abstract: BACKGROUND
  Directional atherectomy (DA) has become popular in some centers to remove atherosclerotic plaques in femoro-popliteal lesions. Although immediate and also short - term outcome data are promising, solid long-term data are warranted to justify the widespread use in daily practice.
  
  
  METHODS
  In this prospective study de novo and restenotic lesions of the femoro-popliteal segments were treated with the Silverhawk device. 161 consecutive patients (164 lesions) with peripheral artery disease (PAD) Rutherford classes 2 to 5 were included from June 2002 to October 2004 and October 2006 to June 2007 (59 % male, mean age 67 +/- 11 years, range 40 to 88) and the outcome analyzed according to the TASC II classification.
  
  
  RESULTS
  DA alone was performed successfully in 28 % (n = 46), adjunctive balloon angioplasty in 65 % (n = 107) and stenting in 7 % (n = 11). The overall technical success rate was 76 % (124 / 164) and the procedural success rate 95 % (154 / 164). At 12 months primary patency rate was 61 % (85 / 140) and the secondary patency rate was 75 % (105 / 140) in the entire cohort, being less favourable in TASC D compared to TASC A to C lesions (p = 0.034 and p < 0.001, respectively). Furthermore the restenosis rate differed trendwise (p = 0.06) between de novo and restenotic lesions. Changes in the ABI and the Rutherford classes were significantly in favour of TASC A to C lesions compared to TASC D after 12 months (p = 0.004). The event free survival (MI, TIA, or restenosis) was 48 % at 12 months and 38.5 % at 24 months. Predictor for restenosis in the multivariable analysis was only male gender (p=0.04).
  
  
  CONCLUSIONS
  The results in TASC D lesions are inferior to those in the lesser stages. DA of femoro-popliteal arteries leads shows a trend to better long-term technical and clinical outcome in de novo lesions compared to restenotic lesions.
authors.affiliation: Department of Angiology, Heart Centre Bad Krozingen, Bad Krozingen, Germany. Sebastian.sixt@herzzentrum.de
authors.forename: Sebastian
authors.initials: S
authors.lastname: Sixt
authors.forename: A
authors.initials: A
authors.lastname: Rastan
authors.forename: U
authors.initials: U
authors.lastname: Beschorner
authors.forename: E
authors.initials: E
authors.lastname: Noory
authors.forename: U
authors.initials: U
authors.lastname: Schwarzwälder
authors.forename: K
authors.initials: K
authors.lastname: Bürgelin
authors.forename: T
authors.initials: T
authors.lastname: Schwarz
authors.forename: C
authors.initials: C
authors.lastname: Müller
authors.forename: M
authors.initials: M
authors.lastname: Hauk
authors.forename: R
authors.initials: R
authors.lastname: Brantner
authors.forename: C
authors.initials: C
authors.lastname: Möhrle
authors.forename: B
authors.initials: B
authors.lastname: Linnemann
authors.forename: R
authors.initials: R
authors.lastname: Macharzina
authors.forename: F-J
authors.initials: FJ
authors.lastname: Neumann
authors.forename: T
authors.initials: T
authors.lastname: Zeller
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000800:Angioplasty, Balloon / Q000295:instrumentation; D001157:Arterial Occlusive Diseases / Q000503:physiopathology / Q000601:surgery / Q000628:therapy*; D017073:Atherectomy / Q000009:adverse effects / Q000295:instrumentation*; D003251:Constriction, Pathologic; D018572:Disease-Free Survival; D004867:Equipment Design; D005260:Female; D005263:Femoral Artery / Q000503:physiopathology / Q000601:surgery; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D011150:Popliteal Artery / Q000503:physiopathology / Q000601:surgery; D016016:Proportional Hazards Models; D011446:Prospective Studies; D012008:Recurrence; D012042:Registries; D018570:Risk Assessment; D012307:Risk Factors; D012720:Severity of Illness Index; D015607:Stents; D013997:Time Factors; D016896:Treatment Outcome; D014654:Vascular Patency; D014656:Vascular Surgical Procedures