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Short- and mid-term outcomes of a novel cool laser atherectomy system for the treatment of lower extremity arteriosclerosis obliterans: a prospective randomized controlled study
REN Shen-hui, WAN Jiu-xuan, YAN Dong, WU Xiao-yu, PENG Zhi-you, WANG Xin, YANG Xin-rui, WANG Rui-hua, LIU Guang, YE Kai-chuang, CUI Chao-yi, SHI Hui-hua, LI Wei-min, QIN Jin-bao, LIU Xiao-bing, YIN Min-yi, LU Xin-wu, ZHAO Zhen
Chinese Journal of Practical Surgery ›› 2026, Vol. 46 ›› Issue (8) : 1119-1124.
PDF(5704 KB)
PDF(5704 KB)
Short- and mid-term outcomes of a novel cool laser atherectomy system for the treatment of lower extremity arteriosclerosis obliterans: a prospective randomized controlled study
Objective To evaluate the safety and efficacy of a domestically developed novel laser atherectomy system for the treatment of lower extremity arteriosclerosis obliterans (LEASO). Methods In this prospective, randomized controlled study, 24 patients with LEASO admitted to Shanghai Jiao Tong University School of Medicine Affiliated Ninth People’s Hospital from February to July 2024 were enrolled. Participants were randomly assigned through a web-based central randomization system to undergo atherectomy with either a novel cool laser (355 nm, n=12) or an excimer laser (308 nm, n=12). The primary efficacy endpoint was the immediate post-procedural improvement in the diameter stenosis (DS%) of the target vessel, as assessed by quantitative angiography. Secondary efficacy endpoints included the immediate technical success rate, the gain in lumen diameter, as well as improvements in the ankle-brachial index (ABI) at 1-month and the limb salvage rate at 1-month and 6-month follow-ups. Safety endpoints comprised the incidence of major adverse events (MAEs), flow-limiting dissections, and device-related adverse events. The efficacy and safety endpoints between the two groups were compared. Results The differences in age [(66.00±8.15) years vs. (72.08±2.75) years, P=0.029] and baseline ABI (0.53±0.21 vs. 0.33±0.17, P=0.018) between the treatment group and the control group were statistically significant, whereas no significant differences were observed in other demographic baseline or lesion characteristics between the two groups (all P>0.05). Compared with the control group, the experimental group showed no statistically significant differences in immediate improvement in luminal stenosis (60.33%±18.20% vs. 50.33%±13.77%), lumen diameter gain [(2.45±1.03) mm vs. (1.80±0.94) mm], procedural success rate (100.0% vs. 100.0%), or in limb patency and salvage rates and target vessel revascularization rates during follow-up (all P>0.05). No MAEs occurred in either group postoperatively. The incidences of flow‑limiting dissection and device‑related adverse events were also not significantly different between the two groups (P>0.05). Conclusion The novel 355‑nm cold laser plaque ablation system demonstrates short‑ and medium‑term efficacy and safety comparable to those of the 308‑nm excimer laser ablation technology in the treatment of LEASO, and may serve as a new alternative for endovascular debulking therapy.
arteriosclerosis obliterans / novel cool laser atherectomy / excimer laser atherectomy / endovascular therapy
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刁永鹏, 谭树平, 兰勇, 等. 准分子激光斑块消蚀联合药物涂层球囊处理下肢动脉硬化闭塞症[J]. 中华普通外科杂志, 2019, 34(8): 663-666. DOI: 10.3760/cma.j.issn.1007-631X.2019.08.005.
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It has been reported that excimer laser atherectomy combined with a drug-coated balloon (ELA+DCB) can achieve better results than simple balloon angioplasty, especially for the treatment of femoropopliteal in-stent restenosis. However, reports on the application of ELA+DCB in China for femoropopliteal arteriosclerosis obliterans are lacking. This study focuses on analysing the effectiveness and safety of ELA+DCB.This was a single-centre retrospective study that enrolled patients from November 2016 to January 2019 who had femoropopliteal arteriosclerosis obliterans treated by ELA+DCB. Preoperative demographics, operative details and postoperative follow-up outcomes were analysed statistically.There were 43 patients with an average patient age of 68.0±8.6 years; 79.1% were male. In 30 cases, the lesions were de novo and the others were in-stent restenosis (ISR). During the procedure, flow-limiting dissection (48.8%) was the main adverse event and there were 17 bailout stent implantations due to dissection. Mean (±sd) ankle-brachial index (ABI) in the patients was 0.42±0.31 before the operation and 0.83±0.13 before discharge. The mean (±sd) follow-up time was 29.35±9.71 months. The primary patency rate was 66.8%, 64.3% and 60.9% at 12, 24 and 36 months. Freedom from target lesion revascularisation (TLR) was 85.7%, 80.7% and 75.3% at 12, 24 and 36 months. Rutherford categories also greatly improved during follow-up. Overall mortality was 6.9% (3/48), and no deaths were related to the intervention.The use of ELA+DCB had good clinical benefit for femoropopliteal arteriosclerosis obliterans, which had good primary patency and freedom from TLR, although intraoperative complications still required attention. Multicentre randomised controlled trials with long-term follow-up are needed.
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Previous in vitro studies demonstrated that during excimer laser ablation of aortic tissue in saline, a fast-expanding and imploding vapor bubble is formed. The present in vivo study was designed to demonstrate the formation of a fast-expanding intraluminal bubble in flowing blood and to assess any damage to the adjacent arterial wall.Excimer laser pulses (one to 10, at 55 mJ/mm2 per pulse) were delivered coaxially in the femoral and iliac arteries of nine normal rabbits. Time-resolved flash photography of dissected arteries in situ demonstrated a 50% diameter increase within 75 microseconds after the laser pulse and a subsequent invagination (150-500 microseconds) that corresponded with the temporal course of the bubble expansion (up to 3.2 mm in diameter) and implosion observed in a hemoglobin solution. One day after laser light delivery, light microscopy (47 arterial segments) showed abrasion of the internal elastic lamina, medial necrosis, and extensive dissection planes filled with red blood cells. The degree (up to 100% medial necrosis) and extent of damage (up to 1.9 mm in length) increased with the number of delivered laser pulses.In blood, each excimer laser pulse generated a fast-expanding and imploding vapor bubble. In vivo, the intraluminal vapor bubble produced microsecond dilation and invagination of the adjacent arterial segment, which induced dissections and extensive wall damage far beyond the penetration depth of 308-nm laser light (< 100 microns). This unique pattern of extensive wall damage observed in the rabbit might explain the mechanism of dissection observed in humans and might have an impact on the acute and chronic outcome after excimer laser coronary angioplasty.
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We investigate the influence of the cladding diameter of an optical delivery fiber on the ablation dynamics of porcine aorta immersed in tetracycline antibiotic solution using 355 nm nanosecond pulses. We manipulate the pressure transients by enforcing a rear rigid interface (applied by an enlargement of the cladding diameter) to the ablated area, which leads to enhanced ablation efficiency along with a reduction in tissue disruption effects. Numerical simulations, based on the finite elements method, are used to study the propagation of the pressure transients within the suggested scheme. Ultrasonic transducers are used for measuring the increased pressure in front of the fiber's facet and the reduced pressure at the fiber's circumference in the presence of large diameter cladding. The increase and decrease are both found to be by a factor of ˜1.8. The width of the cavitation bubble is measured by high-speed photography. An enlargement of 13.8% is demonstrated, at the expense of backward expansion along the fiber's axis. A histopathological in vitro study demonstrates an average enhancement of 12.27% in the diameter of the ablated crater, as well as significant reduction in the disruption effects. Our study sheds light on the potential to improve the ablation efficiency without additional energy cost, along with attaining improved safety for interventional medical procedures.© 2017 Wiley-VCH Verlag GmbH & Co. KGaA, Weinheim.
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Peripheral arterial disease (PAD), caused by atherosclerotic processes, is allied with an increased risk of ischemic events, limb loss, and death. Recently, the use of a solid-state laser at 355 nm within a hybrid catheter was suggested for that purpose. In this work, short nanosecond pulses of a solid-state laser at 355 nm delivered through a hybrid catheter, composed of optical fibers and a blunt mechanical blade, are used to conduct a pre-clinical study and two clinical cases. The pre-clinical study consisted of an atherosclerotic calcified cadaveric leg and a porcine in vivo trial within the iliac artery, respectively. The clinical cases include chronic total occlusions with a calcified lesion. The occluded cadaveric leg is recanalized successfully and no evidence of thermal necrosis is indicated in the histopathology analysis of the porcine study. No arterial wall damage is demonstrated on the animals' treated arteries and no significant impact on blood count and biochemistry analysis is noted in the animal trial. Successful recanalization of the occluded arteries followed by balloon angioplasty is obtained in both clinical cases. Our work constitutes a proof of concept for using a solid-state pulsed laser at 355 nm in atherectomy.© 2017 Wiley-VCH Verlag GmbH & Co. KGaA, Weinheim.
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张超, 冯建宇, 王华, 等. 药物涂层球囊联合准分子激光斑块消蚀术处理下肢动脉硬化闭塞症的临床研究[J]. 中国医药导刊, 2023, 25(10): 1040-1044. DOI: 10.3969/j.issn.1009-0959.2023.10.015.
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We aim to compare cool excimer laser-assisted angioplasty (CELA) versus tibial balloon angioplasty (TBA) in patients with critical limb ischemia (CLI) with tibial artery occlusive disease. The primary end point is sustained clinical improvement (SCI) and amputation-free survival (AFS). The secondary end points are binary restenosis, target extremity revascularization (TER), and cost-effectiveness. From June 2005 to October 2010, 1506 patients were referred with peripheral vascular disease and 572 with CLI. A total of 80 patients underwent 89 endovascular revascularizations (EVRs) for tibial occlusions, 47 using TBA and 42 using CELA. All patients were Rutherford category 4 to 6. Three-year SCI was enhanced with CELA (81%) compared to TBA (63.8%; P =.013). Three-year AFS significantly improved with CELA (95.2%) versus TBA (89.4%; P =.0165). Three-year freedom from TER was significantly improved with CELA (92.9%) versus 78.7% TBA (P =.026). Three-year freedom from MACE was comparable in both the groups (P =.455). Patients with CELA had significantly improved quality time without symptoms of disease or toxicity of treatment (Q-TWiST) at 3 years (10.5 months; P =.048) with incremental cost of €2073.19 per quality-adjusted life year gained. Tibial EVR provides exceptional outcome in CLI. The CELA has superior SCI, AFS, and freedom from TER, with improved Q-TWiST and cost-effectiveness.
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中华医学会外科学分会血管外科学组, 中国医师协会血管外科医师分会. 下肢动脉载药器具规范化应用中国专家共识(2025版)[J]. 中国实用外科杂志, 2025, 45(8): 855-864. DOI:10.19538/j.cjps.issn1005-2208.2025.08.02.
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张琳杰, 左亮, 王新, 等. 准分子激光斑块消蚀术联合药物涂层球囊治疗糖尿病膝下动脉病变的早期疗效分析[J]. 中国临床医学, 2023, 30(1): 31-37. DOI: 10.12025/j.issn.1008-6358.2023.20230078.
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夏成雨, 鄢华, 宋丹, 等. 准分子激光冠状动脉消融术在复杂冠状动脉病变治疗中的安全性和有效性[J]. 临床心血管病杂志, 2025, 41(2): 115-119. DOI: 10.13201/j.issn.1001-1439.2025.02.007.
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In-stent restenosis is an increasing clinical problem. Discordant results have been published regarding the risk of recurrent restenosis after repeat angioplasty for the treatment of in-stent restenosis.One hundred three consecutive patients (107 vessels) underwent repeat percutaneous intervention for the treatment of in-stent restenosis and were entered in a prospective angiographic follow-up program. Repeat balloon angioplasty was performed at 93 lesions (87%) and additional stenting at 14 lesions (13%). The primary success rate was 98%. Six-month angiographic follow-up was performed in 85% of eligible patients. Restenosis was determined by quantitative angiography. Restenosis defined as a >50% diameter stenosis at follow-up was observed at 22% of lesions. The rate of target-lesion revascularization at 6 months was 17%. Repeat intervention for diffuse in-stent restenosis and severe stenosis before repeat intervention were associated with significantly higher rates of recurrent restenosis.The overall restenosis rate after repeat intervention for in-stent restenosis is low. The subgroup of patients with diffuse and/or severe in-stent restenosis, however, is at higher risk of recurrent restenosis and may benefit from alternative therapeutic strategies.
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This study evaluated the clinical and angiographic six-month follow-up after excimer laser coronary angioplasty (ELCA) for restenosed coronary stents.Excimer laser coronary angioplasty has recently been shown to be safe and efficient for the treatment of in-stent restenosis.Ninety-six consecutive patients successfully treated with ELCA within 141 stents were included in a six-month clinical and angiographic follow-up.During follow-up there was one sudden death and one patient with documented myocardial infarction. Angina pectoris classified as > or = Canadian Cardiovascular Society II reoccurred in 49 patients. Follow-up angiography was obtained in 89 patients (93%) with 133 stents. Quantitative coronary angiography revealed a mean diameter stenosis of 77 +/- 10% before intervention, 41 +/- 12% after laser treatment and 11% +/- 12% after adjunctive percutaneous transluminal coronary angioplasty (p < 0.001). Six months after ELCA the mean diameter stenosis had increased to 60 +/- 26% (p < 0.001). A > or =50% diameter stenosis was present in 48 patients (54%); in 24 of these patients diameter stenosis was > or =70%. Total occlusions occurred in an additional 10 patients (11%). There was a trend toward an increased recurrent restenosis rate in patients with diabetes mellitus and long lesions or total occlusions (p = 0.059). Forty-eight patients (50%) received medical treatment after six months. Reinterventions were necessary in 30 patients (31%), and coronary artery bypass surgery was performed in 17 patients (18%). Event-free survival was 50%.Excimer laser angioplasty for in-stent restenosis was associated with a high incidence of recurrent restenosis in this group of patients, suggesting that this technique is unlikely to reduce recurrent in-stent restenosis and that other approaches are necessary.
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利益冲突 所有作者均声明无利益冲突
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