Calcified plaque modification during percutaneous coronary revascularization.

The presence and severity of calcified coronary plaque negatively impacts angiographic and clinical outcomes following percutaneous coronary intervention (PCI). Severe coronary calcification is associated with suboptimal stent delivery, deployment, apposition and expansion which can lead to in-stent restenosis and/or thrombosis. Severe coronary calcification is associated with incremental hazard for adverse clinical events, including death, during 5-10 years following PCI despite the use of new generation drug- eluting stents.

Intravascular Lithotripsy for Treatment of Calcified Coronary Artery Disease.

Intravascular lithotripsy (IVL) uses acoustic shock waves in a balloon-based delivery system to modify severely calcified atherosclerotic coronary vascular lesions in preparation for stent implantation. IVL results in circumferential and longitudinal calcium fracture, which improves transmural vessel compliance and facilitates subsequent stent expansion without requiring high-pressure balloon dilation. Clinical trials have demonstrated IVL to be safe (low rates of major adverse cardiac events in hospital and to 1 year; low rates of severe angiographic complications), effective (high rates of procedural success), and easy to use (little or no learning curve) when applied in the treatment of severely calcified coronary arteries.

Principles of Intravascular Lithotripsy for Calcific Plaque Modification.

A significant proportion of lesions treated with transcatheter interventions in the coronary and peripheral vascular beds exhibit moderate to severe calcific plaques known to portend lower procedural success rates, increased peri-procedural adverse events, and unfavorable clinical outcomes compared with noncalcific plaques. Adapted from lithotripsy technology used for treatment of ureterorenal calculi, intravascular lithotripsy (IVL) is a novel technique for the treatment of severely calcific plaque lesions that uses acoustic shockwaves in a balloon-based delivery system. Shockwaves induce calcium fractures, which facilitate stent expansion and luminal gain.

Intravascular Lithotripsy for Treatment of Calcified Coronary Lesions: Patient-Level Pooled Analysis of the Disrupt CAD Studies.

Objectives: The aim of this pooled analysis was to assess the cumulative safety and effectiveness of coronary intravascular lithotripsy (IVL).

Background: The clinical outcomes of IVL to optimize target lesion preparation in severely calcified de novo coronary stenoses have been examined in 4 prospective studies (Disrupt CAD I [NCT02650128], Disrupt CAD II [NCT03328949], Disrupt CAD III [NCT03595176], and Disrupt CAD IV [NCT04151628]).

Methods: Patient data were pooled from the Disrupt CAD studies, which shared uniform study criteria, endpoint definitions and adjudication, and procedural follow-up.

Intravascular Lithotripsy for Treatment of Severely Calcified Coronary Artery Disease.

Background: Coronary calcification hinders stent delivery and expansion and is associated with adverse outcomes. Intravascular lithotripsy (IVL) delivers acoustic pressure waves to modify calcium, enhancing vessel compliance and optimizing stent deployment.

Objectives: The purpose of this study was to assess the safety and effectiveness of IVL in severely calcified de novo coronary lesions.