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.
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。