Efficacy of intravascular lithotripsy (IVL) in coronary stenosis with severe calcification: a systematic review and meta-analysis of 38 studies

Abstract

Abstract Introduction Heavily calcified coronary lesions impede appropriate stent deployment and expansion, increasing the risk of complications. Intravascular Lithotripsy (IVL) technology disrupts subendothelial calcification by using localized pulsative sonic pressure waves and is a promising technique for patients with severe coronary calcification. Purpose Our aim was to systematically review and summarize available data regarding the safety and efficacy of IVL in preparing severely calcified plaques in coronary before stenting. Methods This study was conducted according to the PRISMA guidelines. We systematically searched PubMed, SCOPUS, and Cochrane databases from their inception to February 23, 2023, for studies assessing the characteristics and outcomes of patients undergoing IVL before stent implantation. The diameter of the vessel lumen before and after IVL as well as stent implantation were analyzed. The occurrence of peri-procedural complications and major adverse cardiovascular events (MACE) in a 30-day period were assessed using a random-effects model. Results This meta-analysis comprised 38 studies including 2,977 patients with heavily calcified coronary lesions. The mean age was 72.2 ± 9.1 years, with an overall IVL procedural success rate of 98% (95% CI: 96%-99%, I2=69.2%) and clinical success of 96% (95% CI: 93%-98%, I2=72.2%), while the in-hospital and 30-days incidence of MACE, myocardial infarction (MI) and death were 8% (95% CI: 6%-11%, I2=84.5%), 5% (95% CI: 2%-8%, I2=85.6%) and 2% (95% CI: 1%-3%, I2=69.3%), respectively. There was a significant increase in the vessel diameter (SMD: 2.47, 95% CI: 1.77-3.17, I2=96%) and a decrease in diameter stenosis (SMD: -3.44, 95% CI: -4.36 to -2.52, I2=97.5%) immediately after IVL application, while it was observed further reduction in diameter stenosis (SMD: -6.57, 95% CI: -7.43 to -5.72, I2=95.8%) and increase in the vessel diameter (SMD: 4.37, 95% CI: 3.63-5.12, I2=96.7%) and the calculated lumen area (SMD: 3.23, 95% CI: 2.10-4.37, I2=98%), after stent implantation. The mean acute luminal gain following IVL and stent implantation was estimated to be 1.27 ± 0.6 mm and 1.94 ± 1.1 mm, respectively. Peri-procedural complications were rare, with just a few cases of perforations, dissection, or no-reflow phenomena recorded. Conclusions The present meta-analysis shows that IVL constitutes an effective and safe technique for preparing severely calcified lesions before stent implantation in coronary arteries. These results support the use of IVL in the high procedural risk setting of severe coronary calcification.