Key result
In a porcine model, intravascular lithotripsy resulted in a significantly higher percent area stenosis at 28 days compared to plain old balloon angioplasty (4.44% vs 0.90%, p=0.031), although overall vascular tissue damage was mild.
Why the study?
Intravascular lithotripsy is used to manage severely calcified lesions, but the biological effects of shock wave on healthy arterial tissue have not been demonstrated.
Does intravascular lithotripsy cause vascular tissue damage compared to plain old balloon angioplasty in healthy porcine peripheral arteries?
Does intravascular lithotripsy cause vascular tissue damage compared to plain old balloon angioplasty in healthy porcine peripheral arteries?
In a porcine model, intravascular lithotripsy of healthy peripheral arteries demonstrated comparable safety to balloon angioplasty, with mild and sustained histological responses and no serious vascular tissue damage.
Answers are grounded in this paper and cite their sources.
IVL appears safe in healthy porcine arteries; hypothesis-generating and requires human trials before any clinical consideration.
Objectives: Intravascular lithotripsy (IVL) is a novel clinical technique for the management of severely calcified lesions. However, the biological effects of shock wave on the healthy arterial tissue have not been demonstrated. The preclinical safety study aimed to investigate the vascular response to IVL shock wave compared to plain old balloon angioplasty (POBA) in porcine peripheral arteries. Methods: The left and right iliofemoral arterial segments of 16 mini-pigs were subjected to IVL and POBA, respectively. The vascular response was evaluated using quantitative vascular angiography (QVA), light microscopy, and scanning electron microscopy (SEM) at 0, 5, and 28 days. Results: With the emission of shock wave, adjacent muscle contraction was observed. QVA showed there was no statistically significant difference in percent diameter stenosis and late lumen loss between the two groups. SEM examination showed the endothelial cell layer was intact in both groups at all timepoints. Under light microscopy, no area stenosis was observed. However, IVL shock wave resulted in significantly higher percent area stenosis and intimal area at 28 days. Neointima score showed a trend toward a higher rate in the IVL group, although there was no statistically significant difference at 28 days. There were no statistically significant differences in the scored parameters between groups at all timepoints. However, the parameters of inflammation and neointima showed a trend toward higher scores in the IVL group. After disruption of the internal elastic lamina, the arteries demonstrated significantly neointimal thickening. Conclusions: The safety and operability of IVL are comparable to POBA. The histological response of healthy arteries to IVL shock wave is mild and sustained. IVL shock wave do not cause serious vascular tissue damage, especially endothelial denudation.
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Liu et al. (2022) studied Healthy peripheral arterial tissue (n=16). Intravascular lithotripsy vs. Plain old balloon angioplasty was evaluated on Area stenosis (%) at 28 days (p=0.031). In a porcine model, intravascular lithotripsy resulted in a significantly higher percent area stenosis at 28 days compared to plain old balloon angioplasty (4.44% vs 0.90%, p=0.031), although overall vascular tissue damage was mild.
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