Purpose: High-intensity focused ultrasound (HIFU) is a potential noninvasive thermal ablation method for the treatment of peripheral artery disease. Dual-mode ultrasound arrays (DMUA) offer the possibility of simultaneous imaging and treatment. In this study, safety and feasibility of femoral artery robot-assisted HIFU/DMUA therapy was assessed. Methods: In 18 pigs (∼50kg), angiography and diagnostic ultrasound were used to visualize diameter and blood flow of the external femoral arteries (EFA). HIFU/DMUA-therapy was unilaterally applied to the EFA dorsal wall using a 3.5 MHz, 64-element transducer, closed-loop-control was used to automatically adjust energy delivery to control thermal lesion formation. A continuous lesion of at least 25 mm was created by delivering 6–8 HIFU shots per imaging plane perpendicular to the artery spaced 1 mm apart. Directly after HIFU/DMUA-therapy and after 0, 3 or 14 days follow up, diameter and blood flow were measured and the skin was macroscopically examined for thermal damage. The tissue was removed for histological analysis. Results: No complications were observed. The most frequently observed treatment effect was formation of scar tissue, predominantly in the adventitia and the surrounding tissue. No damage to the endothelium or excessive damage of the surrounding tissue was observed. There was no significant decrease in the mean arterial diameter after HIFU/DMUA-therapy. Conclusion: HIFU/DMUA therapy successfully targeted the vessel walls of healthy porcine arteries, without causing endothelial damage or other vascular complications. Therefore, this therapy can be safely applied to healthy arterial walls in animals. Future studies should focus on safety and dose-finding in atherosclerotic diseased arteries.
Bibliographical noteFunding Information:
Dr. Ebbini reports grants, personal fees and non-financial support from International Cardio Corporation, during the conduct of the study; grants and personal fees from International Cardio Corporation, grants and personal fees from National Institutes of Health, outside the submitted work; In addition, Dr. Ebbini has a patent Dual mode ultrasound transducer (DMUT) system and method for controlling delivery of ultrasound therapy with royalties paid to International Cardio Corporation, a patent Vascular characterization using ultrasound imaging with royalties paid to International Cardio Corporation, and a patent ULTRASOUND IMAGE FORMATION AND/OR RECONSTRUCTION USING MULTIPLE FREQUENCY WAVEFORMS with royalties paid to International Cardio Corporation.; Dr. Doevendans reports grants from International Cardio Corporation, during the conduct of this study and outside the submitted work; Dr. van Es has a patent NL2016800B1 issued, and a patent US20190125289A1 pending. Other authors have nothing to disclose.
© 2020 The Author(s). Published with license by Taylor & Francis Group, LLC.
- High-intensity focused ultrasound
- arterial vessel wall
- noninvasive therapy
- peripheral artery disease
PubMed: MeSH publication types
- Journal Article
- Research Support, Non-U.S. Gov't