Bosiers Marc, Deloose Koen, Cagiannos Catherine, Verbist Jürgen, Peeters Patrick
Department of Vascular Surgery, AZ St-Blasius.
Vascular. 2009 Jan-Feb;17(1):29-35. doi: 10.2310/6670.2009.00001.
The AngioSculpt Scoring Balloon Catheter (AngioScore, Inc., Fremont, CA) is composed of a semicompliant balloon encircled by three nitinol spiral struts providing targeted lesion scoring on balloon inflation. Between April 2005 and April 2006, procedural and follow-up data on 31 patients (mean age 76 years; 54.8% males) endovascularly treated for severe infrapopliteal disease were collected. The AngioSculpt catheter was used to treat 36 complex, tibioperoneal, atherosclerotic lesions. All patients had symptomatic critical limb ischemia (Rutherford 4-5) and single-vessel runoff to the ankle. Complication-free survival at 1 month was the safety end point, whereas primary patency and limb salvage were the efficacy end points evaluated at 1 year. The AngioSculpt balloon was successfully inflated in all 36 target lesions. Eleven patients (35.5%) required additional stenting for minor dissections or suboptimal stenosis reduction. The 1-month complication-free survival was 96.8%. One-year survival, primary patency, and limb salvage rates were 83.9 +/- 6.6%, 61.0 +/- 9.3%, and 86.3 +/- 6.4%, respectively. The 1-year data show the AngioSculpt Scoring Balloon Catheter to be an effective and safe treatment for infrapopliteal, atherosclerotic lesions in patients with critical limb ischemia. However, more patients, a longer follow-up, and randomized studies comparing it with conventional balloon angioplasty and stenting in the infrapopliteal region are required.
血管塑形评分球囊导管（AngioScore公司，加利福尼亚州弗里蒙特）由一个半顺应性球囊组成，球囊周围环绕着三个镍钛诺螺旋支柱，在球囊充盈时对病变进行靶向评分。在2005年4月至2006年4月期间，收集了31例（平均年龄76岁；54.8%为男性）因严重腘下疾病接受血管内治疗的患者的手术及随访数据。血管塑形导管用于治疗36处复杂的胫腓动脉粥样硬化病变。所有患者均有症状性严重肢体缺血（卢瑟福分级4 - 5级），且踝部为单支血管供血。1个月时无并发症生存为安全终点，而1年时的主要通畅率和肢体挽救率为疗效终点。36处靶病变的血管塑形球囊均成功充盈。11例患者（35.5%）因轻微夹层或狭窄减轻不理想而需要额外置入支架。1个月时无并发症生存率为96.8%。1年生存率、主要通畅率和肢体挽救率分别为83.9±6.6%、61.0±9.3%和86.3±6.4%。1年的数据表明，血管塑形评分球囊导管对于严重肢体缺血患者的腘下动脉粥样硬化病变是一种有效且安全的治疗方法。然而，需要更多患者、更长时间的随访以及将其与腘下区域传统球囊血管成形术和支架置入术进行比较的随机研究。
