Poor outcomes with cryoplasty for lower extremity arterial occlusive disease.

OBJECTIVES

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.

CONCLUSION

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.