Background: Intravascular lithotripsy (IVL) has emerged as a safe and effective modality for treating severely calcified coronary lesions. While the Shockwave™ system is well-established, clinical data on newer IVL platforms such as the Shunmei ShockFast™ system remain limited. Objectives: To evaluate the safety, feasibility, and procedural outcomes of the ShockFast IVL device in patients with heavily calcified de novo coronary artery disease. Methods: We conducted a prospective, single-center case series of 16 patients undergoing percutaneous coronary intervention (PCI) with the ShockFast IVL system between June and December 2025. Inclusion required angiographic or optical coherence tomography (OCT) evidence of severe coronary calcification. The primary efficacy endpoint was acute procedural success and absence of in-hospital MACE. Secondary endpoints included, among others, device deliverability, presence of calcium fracture and post-stent expansion metrics. Results: All patients underwent successful lithotripsy delivery with the ShockFast IVL system. Acute procedural success was 100%, with no intraprocedural complications, abrupt closure, or in-hospital MACE. OCT was performed in 50% of cases and demonstrated calcium fractures in all imaged lesions, with ≥2 fractures in 63% of cases. Median stent expansion was 90% [IQR 9], with no major malapposition or edge dissections. Quantitative coronary analysis showed a median acute lumen gain of 1.86 mm [0.62]. Conclusions: The ShockFast IVL system showed excellent safety and procedural performance in this first-in-center experience. Outcomes were encouraging and consistent with those reported in early-stage studies of other IVL platforms. These findings support the clinical feasibility of ShockFast as a novel tool for calcium modification in complex PCI.

Background: Intravascular lithotripsy (IVL) has emerged as a safe and effective modality for treating severely calcified coronary lesions. While the Shockwave system is well-established, clinical data on newer IVL platforms such as the Shunmei ShockFast system remain limited. Objectives: To evaluate the safety, feasibility, and procedural outcomes of the ShockFast IVL device in patients with heavily calcified de novo coronary artery disease. Methods: We conducted a prospective, single-center case series of 16 patients undergoing percutaneous coronary intervention (PCI) with the ShockFast IVL system between June and December 2025. Inclusion required angiographic or optical coherence tomography (OCT) evidence of severe coronary calcification. The primary endpoints were acute procedural success and in-hospital major adverse cardiovascular events (MACE). Secondary endpoints included device deliverability, calcium fracture (by OCT), and post-stent expansion metrics. Results: All patients underwent successful lithotripsy delivery with the ShockFast IVL system. Acute procedural success was 100%, with no intraprocedural complications, abrupt closure, or in-hospital MACE. OCT was performed in 50% of cases and demonstrated calcium fractures in all imaged lesions, with ≥2 fractures in 63% of cases. Median stent expansion was 90% [IQR 9], with no major malapposition or edge dissections. Quantitative coronary analysis showed a median acute lumen gain of 1.86 mm [0.62]. Conclusions: The ShockFast IVL system demonstrated excellent safety and procedural performance in this first-in-center experience. Outcomes were comparable to those reported with the established Shockwave IVL platform. These findings support the clinical feasibility of ShockFast as a novel tool for calcium modification in complex PCI.

Background: Peripheral endovascular intervention is the preferred revascularization strategy for patients with chronic lower-limb ischemia. Although generally safe, peri-procedural mechanical complications may occur and are influenced by both lesion complexity and procedural strategy. Data identifying determinants of such complications in routine clinical practice remain limited. Methods: We performed a retrospective single-center analysis of consecutive patients undergoing peripheral endovascular intervention for chronic lower-limb ischemia between 2010 and 2023. The primary endpoint was the occurrence of peri-procedural mechanical complications, defined as mechanical adverse events occurring during or immediately following the index intervention and directly related to catheter manipulation, device deployment, or vascular access. Lesion- and procedure-related predictors were evaluated using multivariable logistic regression analysis. Results: A total of 283 index procedures were included. Peri-procedural mechanical complications occurred in 9 procedures (3.2%), with arterial dissection being the most frequent event (2.1%). No cases of peri-procedural bleeding, distal embolization, or emergent surgical conversion were observed. In multivariable analysis, chronic total occlusion (adjusted odds ratio [aOR] 1.89, 95% confidence interval [CI] 1.14–3.11; p = 0.014), moderate-to-severe arterial calcification (aOR 1.74, 95% CI 1.03–2.93; p = 0.039), introducer sheath size ≥7 French (aOR 2.08, 95% CI 1.21–3.57; p = 0.007), and ≥3 vascular access attempts (aOR 1.67, 95% CI 1.00–2.81; p = 0.048) were associated with increased risk of peri-procedural mechanical complications in adjusted analyses. Conclusions: In this real-world institutional registry, peri-procedural mechanical complications during peripheral endovascular intervention were uncommon. Lesion complexity and procedural factors, rather than access route or device type, were the primary determinants of mechanical risk. These findings highlight the importance of careful lesion assessment and procedural planning to optimize peri-procedural safety in routine practice.