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.
Ben H Chew, Victor K F Wong, Mitchell R Humphreys, Wilson Molina, Bodo Knudsen, Mantu Gupta, Duane D Baldwin, Peter Kronenberg, Palle Osther, Olivier Traxer
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引用次数: 0
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.
期刊介绍：
Official Journal of the International Urolithiasis Society
The journal aims to publish original articles in the fields of clinical and experimental investigation only within the sphere of urolithiasis and its related areas of research. The journal covers all aspects of urolithiasis research including the diagnosis, epidemiology, pathogenesis, genetics, clinical biochemistry, open and non-invasive surgical intervention, nephrological investigation, chemistry and prophylaxis of the disorder. The Editor welcomes contributions on topics of interest to urologists, nephrologists, radiologists, clinical biochemists, epidemiologists, nutritionists, basic scientists and nurses working in that field.
Contributions may be submitted as full-length articles or as rapid communications in the form of Letters to the Editor. Articles should be original and should contain important new findings from carefully conducted studies designed to produce statistically significant data. Please note that we no longer publish articles classified as Case Reports. Editorials and review articles may be published by invitation from the Editorial Board. All submissions are peer-reviewed. Through an electronic system for the submission and review of manuscripts, the Editor and Associate Editors aim to make publication accessible as quickly as possible to a large number of readers throughout the world.
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