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

Abstract

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.