SilverHawk斑块切除系统治疗下肢动脉硬化闭塞症的初步临床应用
Preliminary clinical application of SilverHawk directional atherectomy device in arteriosclerosis obliterans of lower extremity
摘要目的 评价SilverHawk直接斑块切除术治疗下肢动脉硬化闭塞症(ASO)的临床疗效及安全性.方法 应用SilverHawk斑块切除系统治疗7例ASO患者,管腔闭塞或狭窄≥80%,病变长度1.8~14.5 cm.临床表现(Fontaine分类):Ⅱb级4例、Ⅲ级1例、Ⅳ级2例.踝肱指数(ABI)0.28~0.65.术后随访观察疗效,观察指标包括临床症状、彩色超声或CTA检测管腔通畅情况.随访和观察指标用中位数表示,统计方法 用两样本的Kolmogorov-Smirnov检验.结果 7例患者的7个闭塞病变均经腔内开通成功(残余狭窄<30%).临床症状均消失或明显改善;Fontaine分类:Ⅰ级6例、Ⅱ a级1例.ABI为0.82~1.18,与术前比较差异有统计学意义(P=0.002).随访1~6个月,ABI仍为0.75~1.14,与术后比较差异无统计学意义(P=0.938),Fontaine分类同术后.结论 SiLverHawk直接斑块切除术是治疗下肢动脉硬化闭塞症的一种安全有效的新方法.
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abstractsObjective To evaluate the clinical efficiency and seeurity of SilverHawk directional atherectomy device in treating arteriosclerosis obliterans of lower extremity.Methods Seyen patients with lower extremity ischemia were treated with SilverHawk directional atherectomy.The lesions length varied from 1.8 to 14.5 cm.Clinical symptoms(Fontaine classification)included 4 cases of grade Ⅱ b,1 case of grade Ⅲ,2 cases of grade Ⅳ.The ABI varied from 0.28 to 0.65.Patency was evaluated with color duplex sonography or CTA besides clinical examination during follow-up.Results Seven occlusive lesions were recanalizated successfully.The technical success(residual stenosis<30%)rate was 100%. Clinical symptoms were obviously improved or disappeared.The ABI varied from 0.82 to 1.18(P=0.002),and Fontaine classification included 6 cases of Ⅰ:1 case of Ⅱ a.Patency rate was 100%and the ABI varied from 0.75 to 1.14(P=0.938).Fontaine classifications keep consistent l-6 nonths after operation.Conclusion SilverHawk drectional atherectomy Was a safe and effective way for treatment of lower arteriosclerosis obliteran.
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