Treatment of Complex Superficial Femoral Artery Lesions With PolarCath Cryoplasty

Use of cryoplasty in patients with severely symptomatic (Rutherford category ≥3) superficial femoral artery (SFA) disease has not been systematically evaluated. From August 2006 to October 2007, 27 consecutive, severely symptomatic patients with 39 lesions in 36 limbs underwent SFA cryoplasty using the PolarCath at 2 centers. Mean age was 74 ± 12 years and 48% were men; 41% had diabetes, 59% had coronary artery disease, and 61% had complex lesions (ostial, calcified, chronic total occlusion, in-stent restenosis, or length ≥150 mm). Adjunctive stenting was required after cryoplasty in 11 of 39 lesions. Immediate procedural success was 100%. After a mean follow-up of 1.2 ± 0.7 years, primary patencies were 67% overall, 75% in the cryoplasty-only group (28 lesions), and 46% in the group requiring adjunctive stent placements. Symptom improvement by ≥1 Rutherford category was seen in 31 (86%) limbs from a mean baseline Rutherford category of 3.16 ± 0.56 to 1.14 ± 1.12 (p <0.0003). Follow-up ankle-brachial index was available for 30 (83%) of the 36 treated limbs, and improvements in mean ankle-brachial index from baseline to follow-up were 0.60 ± 0.10 and 0.85 ± 0.16 respectively (p <0.0007). In conclusion, cryoplasty appears to be effective in the treatment of complex lesions in the SFA distribution with significant intermediate term improvements of peripheral arterial disease symptoms.