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Clinical Outcomes of Intravascular Lithotripsy for Severely Calcified Coronary Lesions: A Single-Center Study
Chien-Po Huang1, Tien-Ping Tsao1,2, Hao-Neng Fu1
1Heart Center, Cheng Hsin General Hospital.
Insights
Intravascular lithotripsy (IVL) effectively treats calcified coronary lesions, with a 1-year MACE rate of 14.9%. End-stage renal disease and stent under-expansion were linked to worse outcomes in this Taiwanese study.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Medical Devices
Background:
- Intravascular lithotripsy (IVL) is an innovative technique for modifying calcified coronary lesions to improve stent expansion.
- Real-world data on IVL efficacy in Asian populations, particularly for complex cases, is limited.
Purpose of the Study:
- To assess the procedural success and safety of IVL in Taiwanese patients with complex calcified coronary lesions.
- To evaluate the 1-year clinical outcomes, including major adverse cardiac events (MACE), following IVL treatment.
- To identify predictors of adverse outcomes after IVL.
Main Methods:
- A retrospective single-center cohort study involving patients treated with IVL for complex calcified coronary lesions.
- Data collection spanned from November 2022 to October 2024.
- Analysis included procedural success, safety, 1-year MACE rates, and subgroup analyses.
Main Results:
- The 1-year MACE rate was 13.6% (raw), with a Kaplan-Meier estimate of 14.9%.
- Key MACE components included cardiac death (1.5%), myocardial infarction (4.5%), and ischemia-driven revascularization (7.6%).
- End-stage renal disease (ESRD) and non-bifurcation lesions were associated with significantly higher MACE and revascularization rates. Stent under-expansion predicted revascularization.
Conclusions:
- Intravascular lithotripsy demonstrates safety and effectiveness in managing complex calcified coronary artery disease.
- Patient outcomes are significantly impacted by renal function (specifically ESRD) and the degree of stent expansion post-procedure.
- IVL offers a viable treatment option, but careful patient selection and procedural optimization are crucial, especially for those with comorbidities like ESRD.
Background:
Intravascular lithotripsy (IVL) is an emerging calcium modification technique designed to optimize stent expansion in patients with severely calcified coronary artery disease. While clinical trials support its efficacy, real-world data from Asia remain limited.
Objectives:
To evaluate the procedural success, safety, and 1-year clinical outcomes of IVL in a single-center Taiwanese cohort.
Methods:
This retrospective single-center cohort study enrolled patients undergoing IVL for complex calcified coronary lesions between November 2022 and October 2024.
Results:
The 1-year MACE rate was 13.6% (raw proportion), driven by cardiac death (1.5%), myocardial infarction (4.5%), ischemia-driven target vessel revascularization (7.6%), and prior in-stent restenosis requiring repeat revascularization (3.0%). The Kaplan-Meier-estimated 1-year cumulative incidence of MACEs was 14.9%. Subgroup analyses showed significantly higher MACE and revascularization rates in patients with end-stage renal disease (ESRD) (p = 0.004, 0.012) and in non-bifurcation lesions (p = 0.014). Multivariable analysis identified ESRD as an independent predictor of MACEs (hazard ratio [HR]: 5.790, p = 0.004) and revascularization (HR: 7.233, p = 0.015); stent under-expansion was also independently associated with revascularization (HR: 7.030, p = 0.010). These findings highlight the clinical performance of IVL and key predictors of adverse outcomes.
Conclusions:
IVL appears to be safe and effective for managing complex calcified coronary lesions. Outcomes in this study were influenced by renal dysfunction and stent expansion.
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