Incidence of Complications Following Coronary Intravascular Lithotripsy, Clinical Outcomes, and Predictors of Complications

Background: This study aimed to evaluate the incidence of complications associated with intravascular lithotripsy (IVL) therapy, assess clinical outcomes, and identify predictors of complications in a real-world patient cohort. Methods: Patients undergoing IVL between May 2019 and September 2024 were enrolled from the BENELUX-IVL registry and categorized based on the occurrence of complications following IVL and concomitant therapy. End points were achievement of residual diameter stenosis <30% on quantitative coronary analysis and major adverse cardiovascular events (MACE) at 1-year follow-up. Kaplan-Meier and binary logistic regression analyses were performed to compare outcomes and to identify predictors of complications. Results: The study included 509 patients (73 ± 9 years, 75% male). Complications occurred in 33 patients (6%), of which 6 complications occurred immediately after IVL (1%). The most frequent complications were flow-limiting coronary dissections (n = 9, 2%), hemodynamic instability (n = 9, 2%), and coronary perforations (n = 7, 1%). These were effectively managed with 30 interventions, resulting in favorable procedural outcomes. Among patients with complications and available quantitative coronary analysis data, residual diameter stenosis <30% was achieved in 28 of 29 lesions (97%). One-year cumulative MACE was 11% (39 patients) and was significantly higher in patients with complications (P < .001), mainly driven by in-hospital events (P < .001). Larger predilatation balloon diameters (P = .032) were associated with complications. Conclusions: In this real-world registry, complications following IVL and concomitant therapy were infrequent. Patients with procedural complications had significantly higher 1-year MACE, primarily driven by in-hospital events. Larger predilatation balloon diameters were a significant predictor of complications.