title: Cryoplasty as endovascular treatment in the femoropopliteal region: hemodynamic results and follow-up at one year.
abstract: BACKGROUND
  Cryoplasty represents an alternative endovascular approach to current techniques for femoropopliteal occlusive disease treatment. Its theoretical advantage compared to angioplasty is associated with the lower appearance of recoil, dissection, and intimal hyperplasia. The aim of this study is to assess the efficacy of cryoplasty in femoropopliteal disease.
  
  
  METHODS
  Eleven patients presenting with critical limb ischaemia (CLI) and Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC) II type A or B lesions in the femoropopliteal region were prospectively included in the study between November 2006 and April 2007. All patients but those with severely calcified lesions underwent cryoplasty (Polarcath Cryoplasty System(R)), and were followed up clinically and by Doppler ultrasound. Outcomes evaluated were technical success, patency at 1, 3, 6, and 12 months, mortality, limb salvage, freedom from restenosis, and freedom from occlusion rates. Statistical analysis used Kaplan-Meier curves.
  
  
  RESULTS
  The mean age of the patients was 76 years (range, 65-89), and 81% of them were females.
  
  
  METHODS
  73% diabetes mellitus, 73% arterial hypertension, 64% dyslipemia, 9% smokers. Clinical: 91% CLI IV and 9% CLI III. Location of lesions: 45% popliteal; 18% superficial femoral; 18% superficial femoral and popliteal; 18% popliteal and anterior tibial. Lesion morphology: 73% stenosis, 27% occlusions. TASC II classification: 64% TASC B and 36% TASC A.Technical success: 100%. Primary, primary assisted, and secondary patency: 91%, 91% and 91% at 3 months; 63%, 82%, and 91% at 6 months; 55%, 73% and 91% at 12 months, respectively. Limb salvage and survival of 91% at 3, 6, and 12 months.
  
  
  CONCLUSIONS
  Cryoplasty in the femoropopliteal region showed a good success rate, with no dissections or significant residual stenosis. However, primary patency and freedom from restenosis rates at 1 year are 55%, both demonstrating a low efficacy of the technique in this territory.
authors.affiliation: Servicio de Angiología y Cirugía Vascular Corporació Sanitària Parc Taulí, Sabadell, Barcelona, Spain. bgonzalo@tauli.cat
authors.forename: Begoña
authors.initials: B
authors.lastname: Gonzalo
authors.forename: Teresa
authors.initials: T
authors.lastname: Solanich
authors.forename: Sergi
authors.initials: S
authors.lastname: Bellmunt
authors.forename: Carolina
authors.initials: C
authors.lastname: Herranz
authors.forename: Elena
authors.initials: E
authors.lastname: González
authors.forename: Gemma
authors.initials: G
authors.lastname: Arnedo
authors.forename: Gemma
authors.initials: G
authors.lastname: Muñoz
authors.forename: Salvador
authors.initials: S
authors.lastname: Florit
authors.forename: Jaime
authors.initials: J
authors.lastname: Hospedales
authors.forename: María Dolores
authors.initials: MD
authors.lastname: Lloret
authors.forename: Joaquín
authors.initials: J
authors.lastname: Vallespín
authors.forename: Antonio
authors.initials: A
authors.lastname: Giménez
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D055109:Ankle Brachial Index; D001157:Arterial Occlusive Diseases / Q000150:complications / Q000175:diagnosis / Q000401:mortality / Q000503:physiopathology / Q000601:surgery*; D003251:Constriction, Pathologic; D003452:Cryosurgery / Q000009:adverse effects; D005260:Female; D005263:Femoral Artery / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000601:surgery*; D005500:Follow-Up Studies; D006083:Graft Occlusion, Vascular / Q000209:etiology / Q000503:physiopathology; D006439:Hemodynamics; D006801:Humans; D007511:Ischemia / Q000175:diagnosis / Q000209:etiology / Q000401:mortality / Q000503:physiopathology / Q000601:surgery*; D053208:Kaplan-Meier Estimate; D023821:Limb Salvage / Q000401:mortality; D008297:Male; D011150:Popliteal Artery / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000601:surgery*; D011446:Prospective Studies; D012086:Reoperation; D018570:Risk Assessment; D012307:Risk Factors; D013030:Spain; D013997:Time Factors; D016896:Treatment Outcome; D018608:Ultrasonography, Doppler; D014654:Vascular Patency; D014656:Vascular Surgical Procedures / Q000009:adverse effects / Q000401:mortality