Aim:
The aim was to evaluate the safety and efficacy of intravascular lithotripsy (IVL) across an unselected in real-world patient cohort.
Sample and Methodology:
We included patients who underwent percutaneous coronary intervention using IVL from May 2019 to November 2023 across 7 centers in 2 European countries. Efficacy endpoints were device success (delivery of the IVL-balloon across the target lesion and administration of therapy without related complications), technical success(TIMI 3 flow and residual stenosis <30% by quantitative coronary analysis) and procedural success(composite of technical success with absence of in-hospital major adverse cardiovascular events(MACE: cardiac death, myocardial infarction or target vessel revascularization)). Safety endpoints were IVL-related complications and MACE at one-year follow-up.
Results:
397 patients (age 73±9 years, 76% male) underwent IVL for 415 lesions. Patient presentation was acute coronary syndrome in 46% of the cases. Diverse target lesions subtypes were addressed, including bifurcations (24%), aorto-ostial (22%), in-stent (38%) and CTO (8%). A mean of 70±23 pulses with an IVL-balloon size of 3.4±0.5mm were administered. Additional plaque modification was used in 64(15%) cases. Post-IVL treatments included stent implantation(77%) and DEB(7%). ICI was utilized in 221(53%) target lesions. Device, technical, and procedural success were achieved in 98%, 89%, and 89% of patients, respectively, while IVL-related complications occurred in 5(1%). At one-year follow-up, MACE was observed in 13%.
Conclusion:
In this real-world registry, IVL demonstrated efficacy across diverse clinical and anatomical scenarios. High success rates, low complication rates and MACE rates were observed acutely and at one-year follow-up.
