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首页> 美国卫生研究院文献>SAGE Choice >Intravascular Lithotripsy for Treatment of Calcified Lower Extremity Arterial Stenosis: Initial Analysis of the Disrupt PAD III Study
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Intravascular Lithotripsy for Treatment of Calcified Lower Extremity Arterial Stenosis: Initial Analysis of the Disrupt PAD III Study

机译：血管内碎石术治疗钙化的下肢动脉狭窄：中断PAD III研究的初步分析

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摘要

To evaluate the performance of peripheral intravascular lithotripsy (IVL) in a real-world setting during endovascular treatment of multilevel calcified peripheral artery disease (PAD). The Disrupt PAD III Observational Study ( identifier ) is a prospective, nonrandomized, multicenter, single-arm observational study assessing the acute safety and effectiveness of the Shockwave Peripheral IVL System for the treatment of calcified, stenotic lower limb arteries. Patients were eligible if they had claudication or chronic limb-threatening ischemia and moderate or severe arterial calcification. Between November 2017 and August 2018, 200 patients (mean age 72.5±8.7 years; 148 men) were enrolled across 18 sites and followed through hospital discharge. In the 220 target lesions, IVL was more commonly used in combination with other balloon-based technologies (53.8%) and less often with concomitant atherectomy or stenting (19.8% and 29.9%, respectively). There was a 3.4-mm average acute gain at the end of procedure; the final mean residual stenosis was 23.6%. Angiographic complications were rare, with only 2 type D dissections and a single perforation following drug-coated balloon inflation (unrelated to the IVL procedure). There was no abrupt closure, distal embolization, no reflow, or thrombotic event. Use of peripheral IVL to treat severely calcified, stenotic PAD in a real-world study demonstrated low residual stenosis, high acute gain, and a low rate of complications despite the complexity of disease.
机译：若要评估血管内碎石术（IVL）在现实世界中在多水平钙化周围动脉疾病（PAD）血管内治疗期间的表现。 Disrupt PAD III观察性研究（标识符）是一项前瞻性，非随机，多中心，单臂的观察性研究，评估了Shockwave Peripheral IVL系统治疗钙化狭窄下肢动脉的急性安全性和有效性。如果患者有lau行或慢性肢体缺血，中度或重度动脉钙化，则符合条件。在2017年11月至2018年8月之间，我们在18个地点招募了200名患者（平均年龄72.5±8.7岁; 148名男性），并进行了出院治疗。在220个目标病灶中，IVL更常与其他基于球囊的技术结合使用（53.8％），而很少同时进行旋切术或支架置入术（分别为19.8％和29.9％）。手术结束时平均有3.4毫米的急性急性发作;最终平均残余狭窄为23.6％。血管造影并发症很少见，只有2个D型夹层，药物涂层球囊扩张后仅有一个穿孔（与IVL手术无关）。没有突然闭合，远端栓塞，无回流或血栓形成事件。在真实世界的研究中，使用外围IVL治疗严重钙化，狭窄的PAD表现出低的残余狭窄，高的急性增高率和低的并发症发生率，尽管疾病很复杂。

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