Bosiers M, Deloose K, Vermassen F, Schroë H, Lauwers G, Lansinck W, Peeters P
Department of Vascular Surgery, AZ St-Blasius Dendermonde, Belgium.
J Cardiovasc Surg (Torino). 2010 Apr;51(2):193-202.
It was the objective of the Cryoplasty CLIMB to evaluate the effectiveness of the PolarCath device in a standard clinical practice in the treatment of infrapopliteal lesions in critical limb ischemia patients.
Between May 2007 and July 2008, 100 patients (72 years, 67%male) with CLI were enrolled in the trial for the treatment of 100 infrapopliteal stenoses or occlusions. The mean lesion length and diameter stenosis were 54.9+/-55.8 mm and 91.3+/-8.3%. Primary endpoint was defined as 12-month primary patency based on duplex. Secondary endopoints were immediate success and 12-month limb salvage and survival rate.
Multiple cryoplasty cycles were performed in 56 cases (2.1 inflations per patient) and in 4 the use of a different size balloon was required. The immediate technical success rate was 95.0% and the stent rate was 17.0%. The 12 month primary patency, limb salvage and survival rates were 55.9+/-7.4%, 93.8+/-2.5% and 81.8+/-3.9%, respectively. Stratification for lesion length did not show significant outcome differences for lesions < or =50.0 mm and those >50.0 mm neither for primary patency (P=0.94), nor for limb salvage (P=0.32).
The cryoplasty technique is effective for the treatment of infrapopliteal lesions in CLI patients. The results seem to be within the range of those of conventional PTA. Especially for shorter lesion (<50.0 mm), the wide-spread use of cryoplasty is not recommended. For lesions with a minimal length of 50.0 mm, the results are encouraging.
冷冻球囊血管成形术CLIMB研究的目的是评估PolarCath装置在标准临床实践中治疗严重肢体缺血患者腘下病变的有效性。
2007年5月至2008年7月，100例（平均年龄72岁，男性占67%）严重肢体缺血患者纳入试验，治疗100处腘下狭窄或闭塞病变。病变平均长度和狭窄直径分别为54.9±55.8毫米和91.3±8.3%。主要终点定义为基于双功超声的12个月主要通畅率。次要终点为即刻成功率、12个月肢体挽救率和生存率。
56例患者进行了多次冷冻球囊血管成形术（每位患者平均2.1次充盈），4例患者需要使用不同尺寸的球囊。即刻技术成功率为95.0%，支架置入率为17.0%。12个月主要通畅率、肢体挽救率和生存率分别为55.9±7.4%、93.8±2.5%和81.8±3.9%。按病变长度分层分析，病变长度≤50.0毫米和＞50.0毫米的患者，主要通畅率（P=0.94）和肢体挽救率（P=0.32）均无显著差异。
冷冻球囊血管成形术技术治疗严重肢体缺血患者的腘下病变有效。结果似乎在传统经皮腔内血管成形术范围内。特别是对于较短病变（＜50.0毫米），不建议广泛使用冷冻球囊血管成形术。对于长度至少为50.0毫米的病变，结果令人鼓舞。
