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.

Material and 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.

Risk factors: 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.

Conclusion: 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.