PD15-10  <i>IN VITRO</i> EVALUATION OF A CLINICAL BURST WAVE LITHOTRIPSY SYSTEM FOR URINARY STONE COMMINUTION (2020)

You have accessJournal of UrologyStone Disease: Shock Wave Lithotripsy (PD15)1 Apr 2020PD15-10 IN VITRO EVALUATION OF A CLINICAL BURST WAVE LITHOTRIPSY SYSTEM FOR URINARY STONE COMMINUTION Shivani Ramesh, Tony Chen*, Adam Maxwell, Bryan Cunitz, Barbrina Dunmire, James Williams, Anthony Gardner, Ziyue Liu, Ian Metzler, Jonathan Harper, Mathew Sorensen, and Michael Bailey Shivani RameshShivani Ramesh More articles by this author , Tony Chen*Tony Chen* More articles by this author , Adam MaxwellAdam Maxwell More articles by this author , Bryan CunitzBryan Cunitz More articles by this author , Barbrina DunmireBarbrina Dunmire More articles by this author , James WilliamsJames Williams More articles by this author , Anthony GardnerAnthony Gardner More articles by this author , Ziyue LiuZiyue Liu More articles by this author , Ian MetzlerIan Metzler More articles by this author , Jonathan HarperJonathan Harper More articles by this author , Mathew SorensenMathew Sorensen More articles by this author , and Michael BaileyMichael Bailey More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000000858.010AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Our goals were to validate stone comminution with an investigative clinical burst wave lithotripsy (BWL) system and to evaluate the use of ultrasonic propulsion to move the stone or fragments under real-time ultrasound imaging as an approach to determine treatment endpoint. METHODS: The Propulse-1 system and SC-60 transducer, used in clinical trials of ultrasonic propulsion and upgraded for BWL trials, were used to fragment 46 human stones (5-7 mm,) and 8 artificial stones, in either a 15-mm or a 4-mm diameter calyx phantom in water. Bursts consisted of 20 cycles at 390 kHz frequency, with either 6 MPa peak negative pressure and 13 Hz pulse repetition rate or 7 MPa peak negative pressure and 6.5 Hz pulse repetition rate. Stones were paired by size and composition. Stones were exposed in 5-minute increments and sieved, with fragments > 2 mm weighed and returned for additional treatment. Pairs of conditions were compared statistically within a framework of survival data analysis for interval censored data. Three blinded reviewers scored ultrasound imaging videos for degree of fragmentation based on stone response to ultrasound propulsion. RESULTS: Overall, 89% of human stones were fully comminuted within 30 minutes, with the majority (32 of 46, 70%) fully treated within 10 minutes (Fig. 1). Fragments remained at 30 minutes in 1 of 28 (4%) calcium oxalate monohydrate stones and 4 of 10 (40%) brushite stones. There were no statistically significant differences in comminution time between the two output settings (p=0.44), water gas content (p=0.65), or calyx diameter (p=0.58). Artificial stones had minimal fragmentation and differed from human stones. Inter-rater correlation on endpoint detection was substantial (Fleiss' Kappa = 0.638, p<0.0001), and individual reviewer sensitivities were 95%, 86%, and 100%. CONCLUSIONS: Eighty-nine percent of human stones were comminuted with a clinical BWL system in 30 minutes under test conditions intended to reflect conditions in vivo. The results support imaging fragment motion with ultrasonic propulsion to determine whether to end or continue treatment. Source of Funding: Funded by NIH NIDDK grants P01 DK043881 and K01 DK007779. © 2020 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 203Issue Supplement 4April 2020Page: e361-e361 Advertisement Copyright & Permissions© 2020 by American Urological Association Education and Research, Inc.MetricsAuthor Information Shivani Ramesh More articles by this author Tony Chen* More articles by this author Adam Maxwell More articles by this author Bryan Cunitz More articles by this author Barbrina Dunmire More articles by this author James Williams More articles by this author Anthony Gardner More articles by this author Ziyue Liu More articles by this author Ian Metzler More articles by this author Jonathan Harper More articles by this author Mathew Sorensen More articles by this author Michael Bailey More articles by this author Expand All Advertisement PDF downloadLoading ...