Rola Piotr, Furtan Łukasz, Włodarczak Szymon, Barycki Mateusz, Kędzierska Michalina, Doroszko Adrian, Włodarczak Adrian, Lesiak Maciej
Faculty of Health Sciences and Physical Culture, Witelon Collegium State University, Legnica, Poland.
Department of Cardiology, Provincial Specialized Hospital in Legnica, Legnica, Poland.
Kardiol Pol. 2023;81(9):878-885. doi: 10.33963/KP.a2023.0152. Epub 2023 Jul 14.
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.
We evaluated the mid-term safety and efficiency of S-IVL in a cohort of 131 consecutive patients with severely calcified coronary lesions.
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.
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%.
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.
钙化病变的冠状动脉介入治疗与较高的不良临床事件发生率相关。初始积极的斑块修饰以及植入后优化对于实现经皮冠状动脉介入治疗（PCI）的良好结果至关重要。最近，冲击波C2血管内碎石术（S-IVL）系统，一种旨在修饰钙化斑块的新型基于声波的设备，已被引入临床实践。
我们评估了131例连续的严重钙化冠状动脉病变患者队列中S-IVL的中期安全性和有效性。
我们回顾性分析了总共131例连续的S-IVL PCI手术。该研究有两个主要纳入标准——存在钙化抵抗病变（定义为非顺应性球囊导管充盈不足）或明显扩张不足的支架（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置入或对先前扩张不足的支架进行优化（支架内残余狭窄小于<20%）。安全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手术6个月后进行临床随访。
住院期间MACCE为4.6%，靶病变血运重建（TLR）为1.5%，1例亚急性致命性支架血栓形成。在6个月随访时，MACCE发生率为7.9%，TLR发生率为3.8%。
我们的中期数据证实血管内碎石术作为一种有价值的策略，在131例连续的严重钙化冠状动脉病变患者队列中进行病变准备和支架优化，具有可接受的安全性和有效性。
