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上市后SOLTIVE超脉冲激光系统注册研究中疗效、安全性、累积激光能量及无石率的前瞻性评估:来自全球腔内泌尿外科研究团队(T.O.W.E.R.)研究联盟的见解

Prospective evaluation of efficacy, safety, cumulative laser energy, and stone-free rates in the post-market SOLTIVE SuperPulsed laser system registry: insights from team of worldwide endourological researchers' (T.O.W.E.R.) research consortium.

作者信息

Chew Ben H, Wong Victor K F, Humphreys Mitchell R, Molina Wilson, Knudsen Bodo, Gupta Mantu, Baldwin Duane D, Kronenberg Peter, Osther Palle, Traxer Olivier

机构信息

University of British Columbia, Vancouver, Canada.

Mayo Clinic, Arizona, USA.

出版信息

Urolithiasis. 2025 Mar 23;53(1):56. doi: 10.1007/s00240-025-01720-5.

Abstract

The Thulium fiber laser (TFL) is a relatively new tool for endoscopic laser lithotripsy. The Endourological Society's T.O.W.E.R. registry sought to evaluate the stone-free rate (SFR) at 3 months following URS. A subset of the study sought to determine the association between cumulative TFL energy and SFRs. 423 patients with planned ureteroscopic lithotripsy using TFL (SOLTIVE, Gyrus ACMI, Inc. d/b/a Olympus Surgical Technologies America) were prospectively enrolled between December 2020 and May 2023 at nine international sites. Baseline clinical characteristics and SFR data for kidney and ureteral stones were separately analyzed according to quartile cumulative TFL energy ranges. Median patient age was 58.0 (IQR: 44-67) years and maximal stone diameters were 9.9 (IQR: 7-12.9) mm and 7.4 (IQR 6.1-9.4) mm for kidney and ureteral stones, respectively. Overall SFR (no fragments) for renal and ureteral stones were 73.0% and 85.7% at 3-months. Cumulative energy levels were divided into quartiles and lower SFRs were observed with the highest quartile for kidney stones (p = 0.001), but not in ureteral stones. This correlated with kidney stone size as larger stones required more energy. The rate of adverse events related to the procedure was 1.9% (8/423). Higher stone burdens had lower stone free rates and required more cumulative laser energy. The TFL is effective in endoscopic lithotripsy. This post-marketing survey demonstrates that TFL is a safe and effective tool for endoscopic laser lithotripsy.

摘要

铥光纤激光器(TFL)是一种相对较新的用于内镜激光碎石术的工具。泌尿外科学会的T.O.W.E.R.注册研究旨在评估输尿管镜检查术后3个月时的无石率(SFR)。该研究的一个子集试图确定累积TFL能量与无石率之间的关联。2020年12月至2023年5月期间,在9个国际地点前瞻性纳入了423例计划使用TFL进行输尿管镜碎石术的患者(SOLTIVE,Gyrus ACMI公司,以美国奥林巴斯外科技术公司名义运营)。根据四分位数累积TFL能量范围,分别分析了肾脏和输尿管结石的基线临床特征和无石率数据。患者中位年龄为58.0岁(四分位间距:44 - 67岁),肾脏和输尿管结石的最大直径分别为9.9毫米(四分位间距:7 - 12.9毫米)和7.4毫米(四分位间距6.1 - 9.4毫米)。肾脏和输尿管结石在3个月时的总体无石率(无碎片)分别为73.0%和85.7%。累积能量水平分为四分位数,肾结石在最高四分位数时观察到较低的无石率(p = 0.001),但输尿管结石未观察到这种情况。这与肾结石大小相关,因为较大的结石需要更多能量。与该手术相关的不良事件发生率为1.9%(8/423)。结石负荷越高,无石率越低,所需的累积激光能量越多。TFL在内镜碎石术中是有效的。这项上市后调查表明,TFL是一种用于内镜激光碎石术的安全有效的工具。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2d9c/11930878/3a461e73485b/240_2025_1720_Fig1_HTML.jpg

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