CryoPlasty Therapy of the Superficial Femoral and Popliteal Arteries: A Single Center Experience

Abstract

Long-term patency remains a significant hurdle in the minimally invasive treatment of arteriosclerosis in the superficial femoral and popliteal arteries. New technologies designed to address the sources of restenosis have recently been introduced. CryoPlasty therapy (Boston Scientific, Natick, Mass) is a new approach designed to significantly reduce injury, elastic recoil, stent implantation, neointimal hyperplasia, and constrictive remodeling. The technique combines the dilatation forces of percutaneous transluminal angioplasty with cold thermal energy applied to the plaque and vessel wall. The cumulative effect of limiting the sources of restenosis with CryoPlasty therapy was shown to demonstrate longer term patency in a prospective, multicenter, Investigational Device Exemption study of the PolarCath Peripheral Dilatation System. The CryoPlasty therapy experience of 1 center is reported, in which 47 lesions in 32 consecutive patients (34 procedures, 33 limbs) were treated. The technical success rate was 96%. There were no type 3 flow-limiting dissections, and only 4 (8.5%) lesions were stented. There were no unanticipated adverse events, specifically no thrombus, acute occlusions, distal embolizations, aneurysms, or groin complications. With an average follow-up of 12 months, only 5 lesions have recurred, 4 requiring re-intervention. The 12-month freedom from restenosis for lesions and limbs treated was 82.2% and 84.4%, respectively. These results are similar to the findings of the Investigational Device Exemption study and are encouraging. CryoPlasty therapy appears to be a viable endovascular therapeutic option to achieve longer term patency without compromising options for future interventions. The lack of early occlusions may be due to a low rate of spiral dissection that may be a particular benefit of this form of angioplasty.