Cryoplasty Therapy for Limb Salvage in Patients with Critical Limb Ischemia

Purpose:To report the 6-month outcomes from a prospective multicenter study investigating the use of cryoplasty (cold balloon angioplasty) to treat below-knee occlusive disease in patients with critical limb ischemia (CLI).Methods:Between August 2004 and October 2005, 108 patients (77 men; mean age 73±12 years, range 41–101) with CLI involving 111 limbs were enrolled in a prospective multicenter trial (Below-the-Knee Chill Study), which was conducted at 16 institutions. The primary study endpoints were acute technical success, defined as the ability to achieve ≤50% residual stenosis and continuous inline flow to the foot, and absence of major (above or below-knee) amputation of the target limb 180 days post procedure.Results:Acute technical success was achieved in 108 (97.3%) of the 111 limbs treated, with only 1 (0.9%) clinically significant dissection (≥type C) and 2 residual stenoses >50%. During the 180-day follow-up, 15 (13.9%) of the initial 108 patients either withdrew or were lost to follow-up. Fi...