Intravascular lithotripsy for severe coronary calcification: superior lesion crossability and comparable safety and efficacy in catheter size selection based on IVUS-guided calcified segment diameter
X Li, Y N Gao, H Qiu, A Gao, M Y XuAbstract
Background
Intravascular lithotripsy (IVL) is an efficient and emerging calcification modifying technique with a short learning curve and few complications. The poor lesion crossing ability of catheters is the main challenges in clinical practice. This study aimed to analyze the safety and effectiveness of IVL therapy using catheters size selected based on the calcification segment diameter measured by intravascular ultrasound (IVUS).
Methods
This is a prospective observational multicenter study enrolled patients with severe coronary calcification and a clinical indication for vessel preparation with IVL. Patients underwent IVUS examinations before IVL and after PCI. Based on the diameter of the shockwave catheters and IVUS measurements, patients were divided into the RVD group (the ratio of the catheter diameter to RVD was 1:1) and the CAC group (the ratio of the catheter diameter to the maximum diameter of calcification segment was 1:1). The primary outcome was procedural success (defined as residual area stenosis <30%, without interventional complications or in-hospital MACE), and the secondary outcome was pretreatment with other calcification modifying techniques.
Results
Between September 2024 to December 2025, 412 patients were enrolled, including 187 patients in the RVD group and 225 patients in the CAC group. The mean age was 67.40 ± 9.37 years, and 71.4% were males. The most common target lesion was the LAD, and 19.2% lesions were chronic total occlusion. The calcified plaque burden was 59.93 ± 5.54 %, the acute lumen gain was 1.15 ± 0.27 mm, and residual area stenosis was 22.06 ± 9.49 %. The IVUS measurements of pre-IVL and post-PCI were compared. After procedure, the MLA and MLD were significantly improved (p<0.001), and the area stenosis and plaque burden was significantly reduced (p<0.001). Regarding the primary outcomes, 93.4% of patients achieved procedure success, with no significant difference between the two groups (p=0.272). Regarding the secondary outcomes, only 18.0% of patients received direct IVL treatment. Compared with the RVD group, patients in the CAC group had significantly lower demands for pretreatment (73.3% vs 92.5%, p<0.001). Compared to the RVD group, more patients in the CAC group receiving direct IVL treatment (26.7% vs 7.5%) or ordinary balloon pretreatment (52.0% vs 49.2%), while fewer patients received special balloon (18.2% vs 27.8%) or other special calcification modifying technique pretreatment (3.1% vs 15.0%), and the differences between the groups were statistically significant (p<0.001).
Conclusions
IVL therapy is a safe and effective calcification modifying technique. The selection of the shockwave catheters size guided by maximum calcification segment diameter on IVUS is expected to improve the lesion crossing ability while ensuring the safety and efficacy of the procedure, and reduce the need for pretreatment with other calcification modifying techniques.Measurements of Calcified Lesions on IVUS.For image description, please refer to the figure legend and surrounding text.Study outcomes and IVUS images.For image description, please refer to the figure legend and surrounding text.