Procedural Success and Safety of a Novel Intravascular Lithotripsy System in Complex Calcified Coronary Lesions: Early Single-Center Experience

Objective: Severe coronary calcification continues to complicate percutaneous coronary intervention (PCI) by hindering device delivery and limiting optimal stent expansion. We report our early clinical experience with a novel intravascular lithotripsy (IVL) system, evaluating procedural success and adverse events before discharge in a cohort treated for severe coronary calcification.
Method: We reviewed 25 consecutive patients with chronic coronary syndrome who underwent IVL-facilitated PCI between May 2025 and January 2026. Angiographically severe calcification was confirmed by intravascular ultrasound (IVUS), defined as a calcium arc ≥180° and/or superficial calcium with acoustic shadowing. IVUS was used to guide lesion assessment and stent optimization. The efficacy endpoint was IVL strategy success, defined as IVL catheter delivery and stent implantation with a minimal stent area ≥80% of the reference lumen without additional plaque modification. Safety was assessed based on intraprocedural events and in-hospital major adverse cardiovascular events (MACE).
Results: The median age was 70 years (interquartile range [IQR], 56–83), and 19 patients (76%) were male. The most frequent target vessels were the left main–left anterior descending (40%) and left anterior descending arteries (36%). IVL strategy success was achieved in 23 cases (92%), and calcium fracture was observed in 15 (60%). Two lesions required additional plaque modification.
Conclusion: In this early experience with a novel IVL system, carefully selected patients with severe coronary calcification demonstrated a high rate of IVL strategy success and an acceptable in-hospital safety profile. Because the cohort was small and follow-up did not extend beyond hospitalization, the results should be considered preliminary and require evaluation in larger prospective studies.

Keywords: Coronary calcification, intravascular lithotripsy, intravascular ultrasound, percutaneous coronary intervention.