title: Procedural and clinical outcomes with catheter-based plaque excision in critical limb ischemia.
abstract: OBJECTIVE
  To examine the safety and efficacy of catheter-based plaque excision as an alternative therapy to surgery, conventional angioplasty, and/or stenting in high-risk patients with critical limb ischemia (CLI).
  
  
  METHODS
  Between August 2003 and August 2004, a prospective evaluation was conducted of consecutive patients with CLI (Rutherford category>or=5) who were treated with endovascular plaque excision at 7 institutions. This study enrolled 69 patients (37 women; mean age 70+/-12 years, range 43-93) with CLI involving 76 limbs. Clinical outcomes were prospectively followed for 6 months. The primary endpoint was major adverse events (death, myocardial infarction, unplanned amputation, or repeat target vessel revascularization) at 30 days. Visible healing of ulcerated tissue, avoidance of any amputation, and performance of less extensive amputation than initially planned were also assessed.
  
  
  RESULTS
  Procedural success was achieved in 99% of cases. Major adverse events occurred in 1% of patients at 30 days and 23% at 6 months. The target lesion revascularization rate was 4%, and there were no unplanned limb amputations. Amputation was less extensive than initially planned or avoided altogether in 92% of patients at 30 days and 82% at 6 months.
  
  
  CONCLUSIONS
  Catheter-based plaque excision is a safe and effective revascularization method for patients with CLI. These findings support further study of this modality as a singular or adjunctive endovascular therapy for limb salvage in CLI.
authors.affiliation: Duke Clinical Research Institute, Durham, North Carolina 27705, USA. david.kandzari@duke.edu
authors.forename: David E
authors.initials: DE
authors.lastname: Kandzari
authors.forename: R Stefan
authors.initials: RS
authors.lastname: Kiesz
authors.forename: David
authors.initials: D
authors.lastname: Allie
authors.forename: Craig
authors.initials: C
authors.lastname: Walker
authors.forename: Peter
authors.initials: P
authors.lastname: Fail
authors.forename: Venkatesh G
authors.initials: VG
authors.lastname: Ramaiah
authors.forename: Joseph
authors.initials: J
authors.lastname: Cardenas
authors.forename: Jose
authors.initials: J
authors.lastname: Vale
authors.forename: Atul
authors.initials: A
authors.lastname: Chopra
authors.forename: Roger S
authors.initials: RS
authors.lastname: Gammon
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000671:Amputation, Surgical; D001157:Arterial Occlusive Diseases / Q000150:complications / Q000628:therapy; D017073:Atherectomy / Q000295:instrumentation; D016638:Critical Illness; D005260:Female; D005263:Femoral Artery / Q000000981:diagnostic imaging; D005500:Follow-Up Studies; D006801:Humans; D007511:Ischemia / Q000209:etiology / Q000401:mortality / Q000628:therapy*; D007866:Leg / Q000098:blood supply*; D007871:Leg Ulcer / Q000150:complications / Q000000981:diagnostic imaging / Q000628:therapy; D008297:Male; D008875:Middle Aged; D018579:Patient Selection; D011859:Radiography; D015996:Survival Rate