Pulsatile Intravascular Lithotripsy: A Novel Mechanism for Peripheral Artery Calcium Fragmentation and Luminal
Renu Virmani1, Aloke V Finn1, Matthew Kutyna1
1CVPath Institute, Gaithersburg, MD, USA.
Summary
Pulsatile intravascular lithotripsy (PIVL) is a new technique that successfully fractured calcified lesions in peripheral artery disease in a cadaver model. This approach demonstrated technical feasibility and achieved significant acute luminal gain, paving the way for clinical studies.
Area of Science:
- Vascular Surgery
- Interventional Cardiology
- Biomedical Engineering
Background:
- Vascular calcification poses a significant challenge in peripheral artery disease (PAD).
- Novel treatment modalities are needed to address complex calcified lesions.
- Pulsatile intravascular lithotripsy (PIVL) offers a potential new approach for intravascular lithotripsy.
Purpose of the Study:
- To evaluate the feasibility of Pulsatile Intravascular Lithotripsy (PIVL) in treating calcified lesions.
- To assess the treatment effect of PIVL on calcium morphology and luminal expansion.
- To investigate PIVL in a cadaveric model of peripheral artery disease.
Main Methods:
- A preclinical device-feasibility study was conducted using surgically isolated, perfused atherosclerotic lower-leg arteries and whole cadaveric lower legs.
- Techniques included micro-computed tomography (μCT), intravascular optical coherence tomography, and digital subtraction angiography.
- Analysis focused on technical success, calcium fracture patterns, and luminal dimensions before and after PIVL.
Main Results:
- PIVL treatment was technically successful in all suitable specimens (N=6), with no vessel perforations.
- Extensive full-thickness calcium fractures were observed in lesions with significant calcium arc and thickness.
- Significant acute luminal gain (mean 1.9 mm), cross-sectional area gain (101.6%), and stenosis reduction (31.7%) were achieved (P < 0.001).
Conclusions:
- Pulsatile intravascular lithotripsy (PIVL) is technically feasible for treating calcified peripheral artery disease lesions in a cadaver model.
- PIVL effectively fractured both circumferential and eccentric calcified lesions.
- The positive results support the initiation of a clinical feasibility study for PIVL.
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