Coronary artery calcification (CAC) is an independent predictor for major cardiovascular events. Additionally, coronary calcium deposition can hinder successful percutaneous coronary intervention (PCI) as a result of inadequate stent expansion, difficulty transiting the catheter through a calcified lesion, coated drug separation from a stent, proclivity for in-stent restenosis and stent thrombosis, and a change to the underlying pharmacokinetics. Consequently, PCI of calcified lesions correlates with worse outcomes.
Shockwave intravascular lithotripsy (IVL) is a novel technique evolved from the established therapy for renal and ureteral calculi that utilizes a percutaneous device to produce acoustic pressure waves resulting in the delivery of energy to break superficial and deep calcium deposits and aid with the subsequent deployment of a vascular stent. Guidance with an intravascular imaging device either with intravascular ultrasound or optical coherence tomography is crucial in defining the calcium density and choosing the optimal lesion modification strategy, i.e., rotational atherectomy, orbital atherectomy or IVL.
The feasibility and safety of IVL in the peripheral vasculature was shown in the Disrupt Peripheral Arterial Disease (PAD) studies and the Disrupt Below the Knee (BTK) study. The Disrupt PAD III study (ClinicalTrials.gov Identifier: NCT02923193) is currently an ongoing prospective multicenter single-arm observational study assessing treatment of moderate and severely calcified femoropopliteal arteries. The disrupt Coronary Artery Disease studies I and II demonstrated the safety and feasibility of IVL in calcified coronary lesions. The Disrupt CAD III (ClinicalTrials.gov Identifier: NCT03595176) is an ongoing prospective, multicenter, single-arm study evaluating the safety and effectiveness of IVL in de novo calcified coronary arteries.
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