Pulsatile Intravascular Lithotripsy: A Novel Mechanism for Peripheral Artery Calcium Fragmentation and Luminal Expansion.

To assess the feasibility and treatment effect of pulsatile intravascular lithotripsy (PIVL) on calcified lesions in a cadaveric model of peripheral artery disease. PIVL represents a novel potential approach to intravascular lithotripsy for the treatment of vascular calcification. In this preclinical device-feasibility study, technical success, calcium morphology and luminal expansion before and after PIVL treatment were evaluated in surgically isolated, perfused atherosclerotic lower-leg arteries and in perfused whole cadaveric lower legs. Analytical methods included micro-computed tomography (μCT), intravascular optical coherence tomography, digital subtraction angiography, and quantitative coronary analysis. Treatment delivery was successful in all whole-leg specimens (N = 6; mean age 74.2, 66 % female) and in the 8 excised vessels with diameter appropriate to the PIVL balloon (2 vessels exceeding diameter specifications were excluded). There were no vessel perforations. After PIVL, excised vessels showed extensive evidence of new, full-thickness fractures in lesions with calcium arc exceeding 152° and with calcium wall thickness between 0.24 mm and 1.42 mm. PIVL fractures were observed in intimal nodules, sheets, shingles, and medial plates. Vessels within whole-leg specimens also showed full-thickness fracturing and a mean of 1.9 ± 0.9 mm in acute luminal gain, 101.6 ± 99.5 % gain in total minimum cross-sectional area, and a 31.7 ± 13.4 % relative reduction in stenosis (P < 0.001 for all analyses). In a cadaveric model, PIVL treatment was technically feasible, fractured both circumferential and eccentric calcium lesions, and resulted in acute luminal gain. A clinical feasibility study of PIVL is currently enrolling.

Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.

Declaration of competing interest RV is a consultant for Abbott Vascular, Boston Scientific, Celonova, OrbusNeich Medical, Terumo Corporation, W. L. Gore, Edwards Lifesciences, Cook Medical, CSI, ReCor Medical, SinoMedical Sciences Technology, Surmodics, Bard BD and a scientific Advisory Board Member of Medtronic and Xeltis. AF has received research grants from AVS, Shockwave, Boston Scientific, Angiodynamics, and Cardiovascular Systems Inc. He is on an advisory board for Boston scientific and consults for Angiodynamics; RSC is the chief technology officer, co-founder, a board member, and holds an equity position in AVS; HSG receives research support from Blue Cross and Blue Shield of Michigan. He is the co-founder of, owns equity in, and is a consultant to AVS. He also owns equity in Jiaxing Bossh Medical Technology Partnership and is a consultant for Osprey Medical. He is the chair of the Clinical Events Committee for the PERFORMANCE trial sponsored by Contego Medical; JCG Is a consultant for AVS. The remaining authors declare no conflicts of interest.