Abstract：
UNASSIGNED: Surgical endarterectomy is currently considered the front-line therapy for the treatment of calcified lesions in the common femoral artery (CFA). Endovascular interventions have evolved, and their use is increasing in frequency. Intravascular lithotripsy (IVL) has shown promising safety and effectiveness in calcified CFA lesions in a small pilot study, but \"real-world\" evidence from a larger cohort is lacking.
UNASSIGNED: The Disrupt PAD III Observational Study (NCT02923193) was a prospective, multicenter registry designed to assess the acute safety and effectiveness of IVL treatment for calcified peripheral arterial disease. Any concomitant treatment with other calcium-modifying technologies as well as definitive treatment strategies was at the discretion of the operators. Patients with CFA lesions were evaluated for acute angiographic safety and effectiveness outcomes following IVL treatment as determined by an independent angiographic core lab.
UNASSIGNED: Common femoral artery treatment was indicated in 177 patients (n=163 could be analyzed based on core-laboratory data) enrolled at 23 sites. Characteristics for 164 treated lesions included moderate-severe calcification 95.1%, diameter stenosis 74.8±17.7%, and lesion length 53.6±53.1 mm. Concomitant calcium-modifying therapy was used in 32.3% of lesions. Final therapy included drug-coated balloons in 68.9% and stenting in 16.5% of lesions. Post-IVL and final residual stenoses were 29.2±16.5%and 23.6±11.5%, respectively. No vascular complications (flow-limiting dissections, perforations, embolization, slow or no reflow, or abrupt closure) were present at the end of the procedure by core-laboratory assessment, with 1 (0.8%) flow-limiting dissection initially occurring immediately following IVL treatment.
UNASSIGNED: This study represents the largest real-world experience of IVL treatment in heavily calcified CFA lesions. Intravascular lithotripsy treatment showed significant stenosis reduction and favorable periprocedural safety in this challenging patient population.
CONCLUSIONS: In this study we show that calcified common femoral artery disease can be safely and effectively treated with shockwave balloon angioplasty with high procedural success and low complication rates and in clinical practice can now be offered as an alternative to surgical treatment in those patients reluctant to or high risk for vascular surgery. This opens another option for clinicians to treat calcified common femoral artery disease without the risk of dissection, perforation or distal embolization that are associated with atherectomy. This study shows that shockwave lithoplasty offers an innovative plaque modification technology to tackle calcified disease in the common femoral artery.
UNASSIGNED: The Disrupt PAD III Observational Study (NCT02923193) was a prospective, multicenter registry designed to assess the acute safety and effectiveness of IVL treatment for calcified peripheral arterial disease. Any concomitant treatment with other calcium-modifying technologies as well as definitive treatment strategies was at the discretion of the operators. Patients with CFA lesions were evaluated for acute angiographic safety and effectiveness outcomes following IVL treatment as determined by an independent angiographic core lab.
UNASSIGNED: Common femoral artery treatment was indicated in 177 patients (n=163 could be analyzed based on core-laboratory data) enrolled at 23 sites. Characteristics for 164 treated lesions included moderate-severe calcification 95.1%, diameter stenosis 74.8±17.7%, and lesion length 53.6±53.1 mm. Concomitant calcium-modifying therapy was used in 32.3% of lesions. Final therapy included drug-coated balloons in 68.9% and stenting in 16.5% of lesions. Post-IVL and final residual stenoses were 29.2±16.5%and 23.6±11.5%, respectively. No vascular complications (flow-limiting dissections, perforations, embolization, slow or no reflow, or abrupt closure) were present at the end of the procedure by core-laboratory assessment, with 1 (0.8%) flow-limiting dissection initially occurring immediately following IVL treatment.
UNASSIGNED: This study represents the largest real-world experience of IVL treatment in heavily calcified CFA lesions. Intravascular lithotripsy treatment showed significant stenosis reduction and favorable periprocedural safety in this challenging patient population.
CONCLUSIONS: In this study we show that calcified common femoral artery disease can be safely and effectively treated with shockwave balloon angioplasty with high procedural success and low complication rates and in clinical practice can now be offered as an alternative to surgical treatment in those patients reluctant to or high risk for vascular surgery. This opens another option for clinicians to treat calcified common femoral artery disease without the risk of dissection, perforation or distal embolization that are associated with atherectomy. This study shows that shockwave lithoplasty offers an innovative plaque modification technology to tackle calcified disease in the common femoral artery.
摘要：
■手术内膜切除术目前被认为是治疗股总动脉（CFA）钙化病变的一线疗法。血管内干预已经发展起来，它们的使用频率正在增加。在一项小型试点研究中，血管内碎石术（IVL）在钙化CFA病变中显示出有希望的安全性和有效性。但缺乏来自更大群体的“真实世界”证据。
■中断PADIII观察性研究（NCT02923193）是一项前瞻性研究，多中心注册旨在评估IVL治疗钙化性外周动脉疾病的急性安全性和有效性。与其他钙修饰技术以及确定的治疗策略的任何伴随治疗都由操作员自行决定。由独立的血管造影核心实验室确定的IVL治疗后评估CFA病变患者的急性血管造影安全性和有效性结果。
■在23个地点招募的177名患者（n=163，可以根据核心实验室数据进行分析）中指出了股动脉共同治疗。164个治疗病变的特征包括中重度钙化95.1%，直径狭窄74.8±17.7%，和病变长度53.6±53.1毫米。在32.3％的病变中使用了伴随的钙修饰疗法。最终治疗包括68.9％的药物涂层球囊和16.5％的病变支架。IVL后和最终残余狭窄分别为29.2±16.5％和23.6±11.5％，分别。无血管并发症（限流夹层，穿孔,栓塞,缓慢或没有回流，或突然关闭)在手术结束时通过核心实验室评估出现，在IVL治疗后立即发生1（0.8％）流量限制夹层。
■这项研究代表了在严重钙化的CFA病变中进行IVL治疗的最大实际经验。在这个具有挑战性的患者群体中，血管内碎石治疗显示出显着的狭窄减少和良好的围手术期安全性。
结论：在这项研究中，我们表明，可以安全有效地使用冲击波球囊血管成形术治疗钙化的股动脉疾病，具有较高的手术成功率和较低的并发症发生率，并且在临床实践中，现在可以作为那些不愿接受血管手术或血管手术风险较高的患者的手术治疗的替代方法。这为临床医生提供了另一种选择，可以在没有夹层风险的情况下治疗钙化的股动脉疾病，与粥样斑块切除术相关的穿孔或远端栓塞。这项研究表明，冲击波碎石术提供了一种创新的斑块修饰技术，可以解决股动脉中的钙化疾病。
■中断PADIII观察性研究（NCT02923193）是一项前瞻性研究，多中心注册旨在评估IVL治疗钙化性外周动脉疾病的急性安全性和有效性。与其他钙修饰技术以及确定的治疗策略的任何伴随治疗都由操作员自行决定。由独立的血管造影核心实验室确定的IVL治疗后评估CFA病变患者的急性血管造影安全性和有效性结果。
■在23个地点招募的177名患者（n=163，可以根据核心实验室数据进行分析）中指出了股动脉共同治疗。164个治疗病变的特征包括中重度钙化95.1%，直径狭窄74.8±17.7%，和病变长度53.6±53.1毫米。在32.3％的病变中使用了伴随的钙修饰疗法。最终治疗包括68.9％的药物涂层球囊和16.5％的病变支架。IVL后和最终残余狭窄分别为29.2±16.5％和23.6±11.5％，分别。无血管并发症（限流夹层，穿孔,栓塞,缓慢或没有回流，或突然关闭)在手术结束时通过核心实验室评估出现，在IVL治疗后立即发生1（0.8％）流量限制夹层。
■这项研究代表了在严重钙化的CFA病变中进行IVL治疗的最大实际经验。在这个具有挑战性的患者群体中，血管内碎石治疗显示出显着的狭窄减少和良好的围手术期安全性。
结论：在这项研究中，我们表明，可以安全有效地使用冲击波球囊血管成形术治疗钙化的股动脉疾病，具有较高的手术成功率和较低的并发症发生率，并且在临床实践中，现在可以作为那些不愿接受血管手术或血管手术风险较高的患者的手术治疗的替代方法。这为临床医生提供了另一种选择，可以在没有夹层风险的情况下治疗钙化的股动脉疾病，与粥样斑块切除术相关的穿孔或远端栓塞。这项研究表明，冲击波碎石术提供了一种创新的斑块修饰技术，可以解决股动脉中的钙化疾病。
