Cryoplasty for peripheral artery disease in an unselected patient population in a tertiary center

Endovascular treatment of peripheral artery occlusive disease has suboptimal long-term patency rates. The addition of cryoplasty to balloon angioplasty, which involves the application of cold thermal energy to atherosclerotic plaque, might improve outcomes and decrease the need for reintervention. At a single tertiary center, we retrospectively analyzed data from the angiograms and medical records of unselected patients who underwent cryoplasty for peripheral artery disease from January 2004 through November 2006. We calculated rates of freedom from amputation, freedom from intervention, and freedom from death and examined the data using the Kaplan-Meier method. Paired t tests were used to compare the ankle-brachial indices before and after cryoplasty. The study population comprised 99 patients who received treatment for 132 atherosclerotic lesions, including 62 lesions in the superficial femoral artery, 28 in the popliteal artery, and 25 in arteries below the knee; 71 patients completed follow-up (64 ± 57 wk). Short-term periprocedural success was achieved in 98.5% of the interventions. Dissections occurred in 12.2% of patients treated successfully without bail-out stenting or additional balloon inflations. At 6 months, more than 88% of the patients were alive and had not had an amputation. However, reintervention was required for 42% of patients. Mean ankle-brachial indices improved significantly after treatment (P < 0.0001). Our results show that cryoplasty for treatment of peripheral artery disease is safe and has a high rate of periprocedural success. However, long-term efficacy is compromised because of the frequent need for reintervention.