Quantitative evaluation of IVL: based on the tunica media gypsum calcification model and a prospective animal study

BackgroundIntravascular lithotripsy (IVL), an emerging adjunctive therapeutic modality, demonstrates potential in managing severely calcified lesions. However, its quantitative efficiency in disrupting calcifications with different characteristics, as well as the degree of damage to normal arteries,...

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Main Authors: Zongwei Liu, Chuang Xu, Bin Zhao, Jiayin Guo, Jingzhong Song, Jiaxue Bi, Yujun Shen, Xiangchen Dai
Format: Article
Language:English
Published: Frontiers Media S.A. 2025-07-01
Series:Frontiers in Cardiovascular Medicine
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Online Access:https://www.frontiersin.org/articles/10.3389/fcvm.2025.1620232/full
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author Zongwei Liu
Zongwei Liu
Zongwei Liu
Chuang Xu
Chuang Xu
Bin Zhao
Bin Zhao
Jiayin Guo
Jiayin Guo
Jingzhong Song
Jingzhong Song
Jiaxue Bi
Jiaxue Bi
Yujun Shen
Yujun Shen
Yujun Shen
Xiangchen Dai
Xiangchen Dai
author_facet Zongwei Liu
Zongwei Liu
Zongwei Liu
Chuang Xu
Chuang Xu
Bin Zhao
Bin Zhao
Jiayin Guo
Jiayin Guo
Jingzhong Song
Jingzhong Song
Jiaxue Bi
Jiaxue Bi
Yujun Shen
Yujun Shen
Yujun Shen
Xiangchen Dai
Xiangchen Dai
author_sort Zongwei Liu
collection DOAJ
description BackgroundIntravascular lithotripsy (IVL), an emerging adjunctive therapeutic modality, demonstrates potential in managing severely calcified lesions. However, its quantitative efficiency in disrupting calcifications with different characteristics, as well as the degree of damage to normal arteries, remains to be confirmed.ObjectivesThis study aimed to: (i) quantitatively evaluate the efficacy of IVL in disrupting different types of calcifications, and (ii) assess the impact of IVL on normal vascular structures.MethodsThe gypsum models with different thicknesses and eccentricities were used to evaluate the effectiveness of IVL in disrupting calcifications with different characteristics. In vivo experiments involved iliofemoral arterial segments of nine Yorkshire experimental swine that were subjected to IVL and PTA working balloons, respectively. In vitro effectiveness of IVL was evaluated using the number of disrupted gypsum rings based on the gypsum models. In vivo effectiveness and safety of IVL were evaluated by digital subtraction angiography (DSA), light microscopy, and immunofluorescence staining based on the experimental swine at 0, 7, and 28 days.ResultsThe gypsum models revealed that the 1.04:1 oversized IVL working balloon could provide an optimal tightness between the balloon and the artery wall. The DSA imaging results showed that IVL significantly increased the immediate treated artery's diameter at +27.12 ± 10.23% compared to the PTA working balloon at +13.72 ± 7.66% in all experimental animals (n = 9, p = 0.0063). The imaging results revealed that IVL treatment significantly alleviated the lumen loss rate of treated arteries compared to the PTA working balloon at 7 (1.10 ± 0.58% vs. 3.27 ± 0.66%) and 28 (4.90 ± 1.60% vs. 10.10 ± 1.53%) days postoperatively (p < 0.05). Histopathological analysis showed the IVL treatment did not increase the inflammatory status, synthesis of collagen, and other artery wall characteristics at 0, 7, and 28 days postoperatively. The immunofluorescence staining results revealed that IVL treatment did not significantly decrease the proportion of smooth muscle cells and endothelial cells in the treated artery.ConclusionOur experiment revealed that the IVL device has good therapeutic effects on different characteristics of calcifications hiding in the tunica media and with good biological safety.
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publisher Frontiers Media S.A.
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series Frontiers in Cardiovascular Medicine
spelling doaj-art-b277dbd49d9d49809fcbeae47686aeb82025-08-20T03:50:16ZengFrontiers Media S.A.Frontiers in Cardiovascular Medicine2297-055X2025-07-011210.3389/fcvm.2025.16202321620232Quantitative evaluation of IVL: based on the tunica media gypsum calcification model and a prospective animal studyZongwei Liu0Zongwei Liu1Zongwei Liu2Chuang Xu3Chuang Xu4Bin Zhao5Bin Zhao6Jiayin Guo7Jiayin Guo8Jingzhong Song9Jingzhong Song10Jiaxue Bi11Jiaxue Bi12Yujun Shen13Yujun Shen14Yujun Shen15Xiangchen Dai16Xiangchen Dai17Department of Vascular Surgery, Tianjin Medical University General Hospital, Tianjin, ChinaTianjin Key Laboratory of Precise Vascular Reconstruction and Organ Function Repair, Tianjin Medical University General Hospital, Tianjin, ChinaDepartment of Pharmacology, Tianjin Key Laboratory of Inflammation Biology, Key Laboratory of Immune Microenvironment and Disease (Ministry of Education), School of Basic Medical Sciences, Tianjin Medical University, Tianjin, ChinaDepartment of Vascular Surgery, Tianjin Medical University General Hospital, Tianjin, ChinaTianjin Key Laboratory of Precise Vascular Reconstruction and Organ Function Repair, Tianjin Medical University General Hospital, Tianjin, ChinaDepartment of Vascular Surgery, Tianjin Medical University General Hospital, Tianjin, ChinaTianjin Key Laboratory of Precise Vascular Reconstruction and Organ Function Repair, Tianjin Medical University General Hospital, Tianjin, ChinaDepartment of Vascular Surgery, Tianjin Medical University General Hospital, Tianjin, ChinaTianjin Key Laboratory of Precise Vascular Reconstruction and Organ Function Repair, Tianjin Medical University General Hospital, Tianjin, ChinaDepartment of Vascular Surgery, Tianjin Medical University General Hospital, Tianjin, ChinaDepartment of Research & Development Center, Sonosemi Medical Co., Ltd., Shenzhen, ChinaDepartment of Vascular Surgery, Tianjin Medical University General Hospital, Tianjin, ChinaTianjin Key Laboratory of Precise Vascular Reconstruction and Organ Function Repair, Tianjin Medical University General Hospital, Tianjin, ChinaDepartment of Vascular Surgery, Tianjin Medical University General Hospital, Tianjin, ChinaTianjin Key Laboratory of Precise Vascular Reconstruction and Organ Function Repair, Tianjin Medical University General Hospital, Tianjin, ChinaDepartment of Pharmacology, Tianjin Key Laboratory of Inflammation Biology, Key Laboratory of Immune Microenvironment and Disease (Ministry of Education), School of Basic Medical Sciences, Tianjin Medical University, Tianjin, ChinaDepartment of Vascular Surgery, Tianjin Medical University General Hospital, Tianjin, ChinaTianjin Key Laboratory of Precise Vascular Reconstruction and Organ Function Repair, Tianjin Medical University General Hospital, Tianjin, ChinaBackgroundIntravascular lithotripsy (IVL), an emerging adjunctive therapeutic modality, demonstrates potential in managing severely calcified lesions. However, its quantitative efficiency in disrupting calcifications with different characteristics, as well as the degree of damage to normal arteries, remains to be confirmed.ObjectivesThis study aimed to: (i) quantitatively evaluate the efficacy of IVL in disrupting different types of calcifications, and (ii) assess the impact of IVL on normal vascular structures.MethodsThe gypsum models with different thicknesses and eccentricities were used to evaluate the effectiveness of IVL in disrupting calcifications with different characteristics. In vivo experiments involved iliofemoral arterial segments of nine Yorkshire experimental swine that were subjected to IVL and PTA working balloons, respectively. In vitro effectiveness of IVL was evaluated using the number of disrupted gypsum rings based on the gypsum models. In vivo effectiveness and safety of IVL were evaluated by digital subtraction angiography (DSA), light microscopy, and immunofluorescence staining based on the experimental swine at 0, 7, and 28 days.ResultsThe gypsum models revealed that the 1.04:1 oversized IVL working balloon could provide an optimal tightness between the balloon and the artery wall. The DSA imaging results showed that IVL significantly increased the immediate treated artery's diameter at +27.12 ± 10.23% compared to the PTA working balloon at +13.72 ± 7.66% in all experimental animals (n = 9, p = 0.0063). The imaging results revealed that IVL treatment significantly alleviated the lumen loss rate of treated arteries compared to the PTA working balloon at 7 (1.10 ± 0.58% vs. 3.27 ± 0.66%) and 28 (4.90 ± 1.60% vs. 10.10 ± 1.53%) days postoperatively (p < 0.05). Histopathological analysis showed the IVL treatment did not increase the inflammatory status, synthesis of collagen, and other artery wall characteristics at 0, 7, and 28 days postoperatively. The immunofluorescence staining results revealed that IVL treatment did not significantly decrease the proportion of smooth muscle cells and endothelial cells in the treated artery.ConclusionOur experiment revealed that the IVL device has good therapeutic effects on different characteristics of calcifications hiding in the tunica media and with good biological safety.https://www.frontiersin.org/articles/10.3389/fcvm.2025.1620232/fullintravascular lithotripsyeccentric calcificationswine modelendovascular treatmentgypsum model
spellingShingle Zongwei Liu
Zongwei Liu
Zongwei Liu
Chuang Xu
Chuang Xu
Bin Zhao
Bin Zhao
Jiayin Guo
Jiayin Guo
Jingzhong Song
Jingzhong Song
Jiaxue Bi
Jiaxue Bi
Yujun Shen
Yujun Shen
Yujun Shen
Xiangchen Dai
Xiangchen Dai
Quantitative evaluation of IVL: based on the tunica media gypsum calcification model and a prospective animal study
Frontiers in Cardiovascular Medicine
intravascular lithotripsy
eccentric calcification
swine model
endovascular treatment
gypsum model
title Quantitative evaluation of IVL: based on the tunica media gypsum calcification model and a prospective animal study
title_full Quantitative evaluation of IVL: based on the tunica media gypsum calcification model and a prospective animal study
title_fullStr Quantitative evaluation of IVL: based on the tunica media gypsum calcification model and a prospective animal study
title_full_unstemmed Quantitative evaluation of IVL: based on the tunica media gypsum calcification model and a prospective animal study
title_short Quantitative evaluation of IVL: based on the tunica media gypsum calcification model and a prospective animal study
title_sort quantitative evaluation of ivl based on the tunica media gypsum calcification model and a prospective animal study
topic intravascular lithotripsy
eccentric calcification
swine model
endovascular treatment
gypsum model
url https://www.frontiersin.org/articles/10.3389/fcvm.2025.1620232/full
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