The role for cryoplasty in the treatment of infrainguinal artery disease: case studies.

Cryoplasty has been shown to be safe and effective for the treatment of atherosclerotic lesions in the peripheral vasculature and offers the promise of improving on the results of percutaneous transluminal angioplasty (PTA) by limiting dissection, vessel recoil, and restenosis. The PolarCath Peripheral Dilatation System utilizes nitrous oxide rather than the standard mixture of saline and contrast medium to inflate and cool the balloon to the desired temperature of approximately -10 degrees C. Cryoplasty can be used in combination with other therapies, can be repeated, and offers the advantage of not leaving any foreign objects in the body. In a multicenter registry of claudicants with de novo or restenotic femoropopliteal lesions and in a multicenter trial of CLI patients with infrapopliteal lesions (86.9% mean diameter stenosis, 33.9% occlusions), favorable results with primary cryoplasty included minimal need for bailout stenting, avoidance of repeat revascularization, and high amputation-free survival. We review cases in which cryoplasty was used for diffuse superficial femoral and popliteal artery disease, for infrapopliteal stenosis and occlusion, for in-stent restenosis, and as part of a hybrid strategy for treating multilevel occlusive disease. As these clinical cases demonstrate, cryoplasty therapy can be employed effectively as a primary strategy, or in conjunction with debulking, for the treatment of lesions of varying severity in different segments of the infrainguinal vasculature. Further studies will be required to better define the role of this therapy relative to the other modalities that are currently available for the treatment of femoropopliteal and infrapopliteal disease.