Comparison of Vascular Injury From Intravascular Lithotripsy, Cutting, or Ultra-High-Pressure Balloons During Coronary Calcium Modification

BACKGROUND: Effective modification of heavily calcified coronary lesions is critical for successful percutaneous coronary intervention (PCI). Intravascular lithotripsy (IVL), cutting balloons (CBs), and ultra-high-pressure balloons (UHBs) are used commonly, yet data comparing their effectiveness and safety for calcified lesion modification remain unavailable. OBJECTIVES: The aim of this study was to compare the effects of IVL, a CB, and a UHB on calcified coronary lesions in human cadaveric arteries, focusing on calcium fracture formation and vascular injury. METHODS: Seventeen calcified lesions from 6 cadavers were randomized to treatment with IVL (n = 5), the CB (n = 6), or the UHB (n = 6). Pre- and post-treatment optical coherence tomography, micro-computed tomography (CT), and histology were coregistered to evaluate calcium fractures and medial injury. RESULTS: Fractures confirmed by micro-CT and histology were observed in 80% of IVL-treated lesions, 66.7% treated with the CB, and 33.3% treated with the UHB (P = 0.350). Medial injury occurred significantly less frequently with IVL (20.0%) compared with the CB (83.3%) and the UHB (100%) (P = 0.012). In histologic sections with a calcium arc of ≥180°, IVL induced fractures in 100% of sections, all without medial injury, while the CB and UHB caused fractures without medial injury in 16.7% and 20.0% of sections, respectively (P = 0.007). For calcium arcs <180°, IVL produced fractures in 57.1% of sections, all without medial injury, compared with the CB (11.1% without medial injury) and UHB (0% without medial injury) (P = 0.008). CONCLUSIONS: IVL effectively modifies calcified lesions with less medial vascular injury compared with a CB and a UHB.