Cryoplasty for femoropopliteal arterial disease: late angiographic results of initial human experience

Abstract

Purpose: A new form of angioplasty, called cryoplasty, was developed to improve the late results typically associated with percutaneous transluminal angioplasty. Cryoplasty combines the dilation force of percutaneous transluminal angioplasty with the delivery of cold thermal energy to the vessel wall. This study reports the authors' early clinical experience with cryoplasty in patients with femoropopliteal disease.

Materials and methods: Fifteen patients with femoropopliteal arterial lesions were treated with cryoplasty (CryoVascular Systems, Los Gatos, CA). Cryoplasty was performed at 6 atm of pressure and delivered at -10 degrees C for 60 seconds. The ankle-brachial index (ABI) was measured at baseline, 24 hours after cryoplasty, and at 1 and 3 months during follow-up. Repeated angiography was performed at 6 and 18 months to determine short-term and late primary patency.

Results: Cryoplasty was technically successful in 93% of patients (< 30% residual stenosis and less then grade C dissection). ABIs at baseline were 0.64 +/- 0.08 and improved the day after cryoplasty to 0.95 +/- 0.09 (P < .05). ABIs were well maintained at 1 and 3 months with measurements of 0.94 +/- 0.09 and 0.92 +/- 0.10, respectively (P < .05 vs baseline). Baseline angiographic diameter stenosis improved significantly immediately following cryoplasty (86% +/- 12% to 16% +/- 3%; P < .05). Angiography at 6 months revealed 0% binary restenosis and insignificant change in residual stenosis from the acute cryoplasty results (16 +/- 3% vs 21 +/- 5%; P = NS). Late angiographic follow-up at 14 months +/- 4 demonstrated primary patency of 83.3%.

Conclusion: Cryoplasty was able to achieve substantial dilation of femoropopliteal lesions with well-preserved late angiographic patency. Cryoplasty represents a potential advance in the field of endovascular medicine.