Abstract：
BACKGROUND: Coronary interventions in calcified lesions are associated with a higher rate of adverse clinical events. Initial aggressive plaque modification along with post-implantation optimization is pivotal for achieving a favorable outcome of percutaneous coronary intervention (PCI). Recently, the Shockwave C2 Intravascular Lithotripsy (S-IVL) System, a novel acoustic wave-based device designed to modify calcified plaque, has been introduced into clinical practice.
OBJECTIVE: We evaluated the mid-term safety and efficiency of S-IVL in a cohort of 131 consecutive patients with severely calcified coronary lesions.
METHODS: We retrospectively analyzed a total of 131 consecutive S-IVL PCI procedures. The study had two main inclusion criteria - the presence of a calcified resistant lesion (defined by inadequate non-compliant balloon catheter inflation) or a significantly underexpanded stent (more than 20% of reference diameter). The study had two primary endpoints - successful clinical outcome and safety concerns. Clinical success was defined as effective stent deployment or optimization of a previously underexpanded stent (with less than <20% in-stent residual stenosis). Safety outcomes were defined as periprocedural complications, such as device failure and major adverse cardiac and cerebrovascular events (MACCE). Clinical follow-up was performed at the end of hospitalization and 6 months after the index procedure.
RESULTS: In-hospital MACCE was 4.6% with 1.5% target lesion revascularization (TLR) and one case of subacute fatal stent thrombosis. At 6-month follow-up, the MACCE rate was 7.9% with a concomitant TLR rate of 3.8%.
CONCLUSIONS: Our mid-term data confirm acceptable safety and efficacy of intravascular lithotripsy as a valuable strategy for lesion preparation and stent optimization in a cohort of 131 consecutive patients with severely calcified coronary lesions.
OBJECTIVE: We evaluated the mid-term safety and efficiency of S-IVL in a cohort of 131 consecutive patients with severely calcified coronary lesions.
METHODS: We retrospectively analyzed a total of 131 consecutive S-IVL PCI procedures. The study had two main inclusion criteria - the presence of a calcified resistant lesion (defined by inadequate non-compliant balloon catheter inflation) or a significantly underexpanded stent (more than 20% of reference diameter). The study had two primary endpoints - successful clinical outcome and safety concerns. Clinical success was defined as effective stent deployment or optimization of a previously underexpanded stent (with less than <20% in-stent residual stenosis). Safety outcomes were defined as periprocedural complications, such as device failure and major adverse cardiac and cerebrovascular events (MACCE). Clinical follow-up was performed at the end of hospitalization and 6 months after the index procedure.
RESULTS: In-hospital MACCE was 4.6% with 1.5% target lesion revascularization (TLR) and one case of subacute fatal stent thrombosis. At 6-month follow-up, the MACCE rate was 7.9% with a concomitant TLR rate of 3.8%.
CONCLUSIONS: Our mid-term data confirm acceptable safety and efficacy of intravascular lithotripsy as a valuable strategy for lesion preparation and stent optimization in a cohort of 131 consecutive patients with severely calcified coronary lesions.
摘要：
背景：冠状动脉介入治疗钙化病变与较高的临床不良事件发生率相关。初始的积极斑块修饰以及植入后的优化对于实现经皮冠状动脉介入治疗（PCI）的有利效果至关重要。最近,冲击波C2血管内碎石术（S-IVL），一种新颖的基于声波的设备，旨在修饰钙化斑块，已被引入临床实践。
目的：我们评估了S-IVL在冠状动脉严重钙化病变的所有人群中的中期安全性和有效性。
方法：我们回顾性分析了总共131例连续的S-IVLPCI手术。该研究有两个主要的纳入标准：钙化，阻力损伤(定义为非投诉球囊导管膨胀不足)或支架明显扩张不足(超过参考直径的20%)。该研究有两个主要终点-成功的临床结果和安全性问题。临床成功定义为有效的支架展开或优化先前扩张不足的支架(支架内残余狭窄小于20%)。安全性结果定义为围手术期并发症，如设备故障，和主要不良心脑血管事件（MACCE）。在住院结束时和索引程序后6个月进行临床随访。
结果：院内MACCE为4.6％，目标病变血运重建（TLR）为1.5％，亚急性致死性支架血栓形成1例。在6个月的随访中，MACCE率为7.9%,同时TLR率为3.8%.
结论：我们的中期数据证实，在冠状动脉严重钙化病变的所有患者队列中，血管内碎石术作为一种有价值的病变准备和支架优化策略，具有可接受的安全性和有效性。
目的：我们评估了S-IVL在冠状动脉严重钙化病变的所有人群中的中期安全性和有效性。
方法：我们回顾性分析了总共131例连续的S-IVLPCI手术。该研究有两个主要的纳入标准：钙化，阻力损伤(定义为非投诉球囊导管膨胀不足)或支架明显扩张不足(超过参考直径的20%)。该研究有两个主要终点-成功的临床结果和安全性问题。临床成功定义为有效的支架展开或优化先前扩张不足的支架(支架内残余狭窄小于20%)。安全性结果定义为围手术期并发症，如设备故障，和主要不良心脑血管事件（MACCE）。在住院结束时和索引程序后6个月进行临床随访。
结果：院内MACCE为4.6％，目标病变血运重建（TLR）为1.5％，亚急性致死性支架血栓形成1例。在6个月的随访中，MACCE率为7.9%,同时TLR率为3.8%.
结论：我们的中期数据证实，在冠状动脉严重钙化病变的所有患者队列中，血管内碎石术作为一种有价值的病变准备和支架优化策略，具有可接受的安全性和有效性。
