张玉平 王洪浩 何国祥
作者单位:550018 贵阳,贵黔国际总医院心血管内科
通信作者:何国祥,电子信箱:heguoxiangsw@aliyun.com
引用本文:
张玉平, 王洪浩, 何国祥. 血管内冲击波碎石术在冠状动脉严重钙化病变中应用的研究进展[J]. 中国心血管杂志, 2024, 29(4): 379-381. DOI: 10.3969/j.issn.1007-5410.2024.04.013.
A:血管内冲击波碎石术(IVL)发射器(①)、连接器电缆(②)和导管(③);B:IVL发射器产生电火花,在集成球囊内产生快速膨胀的蒸汽泡,同时声压波向外呈球形辐射,可选择性地改变血管钙化灶
Disrupt CAD Ⅲ(Disrupt Coronary Artery Disease Ⅲ)研究是一项前瞻性、单臂、多中心研究,纳入了来自4个国家中47个中心的431例患者,研究对象均为存在血管严重钙化病变且接受经皮冠状动脉介入治疗的冠心病患者。研究者对入选患者先进行冠状动脉IVL治疗,再行球囊扩张和支架置入,将主要安全性终点定义为30 d内无不良心血管事件(包括心原性死亡、心肌梗死或靶血管重建);主要疗效终点定义为手术成功,即住院期间不发生不良心血管事件的情况下成功置入支架,且残余狭窄率<50%。研究结果表明,主要安全终点率为92.2%,95%CI下限为89.9%,高于预先定义的客观表现目标84.4%( P<0.0001);主要疗效终点率为92.4%,95%CI下限为90.2%,高于预先定义的客观表现目标83.4%( P<0.0001)。光学相干断层成像分析显示,IVL术后67.4%的病变中存在多平面和纵向钙化斑块断裂,但有钙化断裂组与无钙化断裂组相比,最小支架面积[(6.3±2.1)mm2比(6.8±2.1)mm2, P=0.26]和狭窄面积(22.4%±19.1%比20.9%±18.7%,P=0.72)均无统计学差异,支架扩张程度均良好(100.3%±29.8%比104.9%±26.9%,P=0.49)。
冠状动脉IVL的适应证、禁忌证及并发症
冠状动脉IVL的适应证包括:(1)冠状动脉原位中重度钙化病变、冠状动脉钙化导致的支架膨胀不全和晚期支架内血栓;(2)非顺应性球囊、切割球囊或棘突球囊无法充分扩张的钙化病变;(3)腔内影像学评估提示严重钙化病变:血管内超声检查提示Ⅳ级,钙化范围>270°,或光学相干断层成像提示钙化角度>180°、钙化长度>5 mm及钙化厚度>0.5 mm,即钙化积分达到4分为首选;(4)RA和准分子激光冠状动脉内成形术治疗失败的钙化病变,极具挑战性的钙化病变,如急性冠脉综合征、无保护左主干病变和慢性完全闭塞病变。
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