title: Poor outcomes with cryoplasty for lower extremity arterial occlusive disease.
abstract: OBJECTIVE
  Cryoplasty has been proposed as a different therapy to address the problems of recurrent lesions. We reviewed our experience with cryoplasty to determine its outcome treating patients with lesions in native vessels and within stents.
  
  
  METHODS
  A retrospective review of all patients undergoing cryotherapy between 2004 and 2008 was conducted. Patency was defined by at least one of the following criteria: flow through the vessel demonstrated by angiography or duplex ultrasonography, maintenance of an ankle-brachial index (ABI) greater than 0.10 above the preprocedural value, or maintenance of a palpable pedal pulse that was absent before the procedure in an asymptomatic patient. Patency, limb salvage, symptomatic improvement, and freedom from surgical bypass were determined with Kaplan-Meier survival analysis and compared by log-rank testing. Multivariate analysis was performed by Cox proportional-hazards regression.
  
  
  RESULTS
  Eighty-eight cryoplasty procedures were performed in 71 patients, with 35 procedures for in-stent restenosis and 37 for native vessel disease. Sixteen of 88 procedures in grafts were excluded from analysis secondary to combined disease process and/or bypass graft stenosis. Lesions treated with cryoplasty had an average of 2.9 prior endovascular interventions. Eighty-five percent of the lesions were described as complex (multifocal, diffuse, or occlusion) and the mean lesion length was 15 +/- 10 cm. Initial cryoplasty technical success rate was 68% (25 of 37) for native vessels and 71% (25 of 35) for in-stent procedures. One year primary patency for the native vs stent group was 17% vs 28%, respectively (P = .18). The 1-year primary assisted patency for the native vs stent group was 28% vs 47%, respectively (P = .33). The 1-year secondary patency for the native vs stent group was 41% vs 57% (P = .42), respectively. Freedom from claudication at 1 year for the native vs stent group was 32% vs 21% (P = .80). Compared to balloon angioplasty, cryoplasty has an averaged up-cost of $1851.50 per procedure.
  
  
  CONCLUSIONS
  Cryoplasty was used in patients with extensive disease and multiple prior interventions. Cryoplasty provided poor patency rates and poor relief from claudication at 1 year in this population. Overall, cryoplasty seems to be an expensive endovascular tool with marginal clinical improvement in our experience.
authors.affiliation: Division of Vascular Surgery, Eastern Virginia Medical School, Norfolk, Va 23507, USA.
authors.forename: Gregory C
authors.initials: GC
authors.lastname: Schmieder
authors.forename: Megan
authors.initials: M
authors.lastname: Carroll
authors.forename: Jean M
authors.initials: JM
authors.lastname: Panneton
mesh_terms: D000368:Aged; D055109:Ankle Brachial Index; D001157:Arterial Occlusive Diseases / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D003362:Cost-Benefit Analysis; D017679:Cryotherapy / Q000009:adverse effects / Q000191:economics; D005240:Feasibility Studies; D005260:Female; D006083:Graft Occlusion, Vascular / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D006801:Humans; D007383:Intermittent Claudication / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D053208:Kaplan-Meier Estimate; D023821:Limb Salvage; D035002:Lower Extremity / Q000098:blood supply*; D008297:Male; D008875:Middle Aged; D016016:Proportional Hazards Models; D012189:Retrospective Studies; D018570:Risk Assessment; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome; D018616:Ultrasonography, Doppler, Duplex; D014654:Vascular Patency; D014656:Vascular Surgical Procedures