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Efficacy and safety of the EMS Swiss LithoClast® Trilogy for PCNL: results of the European multicentre prospective study on behalf of European Section of UroTechnology.

Published version
Peer-reviewed

Type

Article

Change log

Authors

Tanase, F 
Saeb-Parsy, K 
Atassi, N 
Endriss, R 

Abstract

PURPOSE: PCNL requires a lithotrite to efficiently break stones, and some devices include active suction to remove the fragments. We set out to determine the efficacy and safety of the Swiss LithoClast® Trilogy, in a prospective European multicentre evaluation and compared it to published stone clearance rates for Trilogy based on surface area (68.9 mm2/min) and using the 3D calculated stone volume (526.7 mm3/min). METHODS: Ten European centres participated in this prospective non-randomized study of Trilogy for PCNL. Objective measures of stone clearance rate, device malfunction, complications and stone-free rates were assessed. Each surgeon subjectively evaluated ergonomic and device effectiveness, on a 1-10 scale (10 = extremely ergonomic/effective) and compared to their usual lithotrite on a 1-10 scale (10 = extremely effective). RESULTS: One hundred and fifty seven PCNLs using Trilogy were included (53% male, 47% female; mean age 55 years, range 13-84 years). Mean stone clearance rate was 65.55 mm2/min or 945 mm3/min based on calculated 3D volume. Stone-free rate on fluoroscopy screening at the end of the procedure was 83%. Feedback for suction effectiveness was 9.0 with 9.1 for combination and 9.0 for overall effectiveness compared to lithotrite used previously. Ergonomic score was 8.1, the least satisfactory element. Complications included 13 (8.2%) Clavien-Dindo Grade II and 2 (1.3%) Grade III. Probe breakage was seen in 9 (5.7%), none required using a different lithotrite. CONCLUSIONS: We have demonstrated that Trilogy is highly effective at stone removal. From a user perspective, the device was perceived by surgeons to be highly effective overall and compared to the most commonly used previous lithotrite, with an excellent safety profile.

Description

Keywords

LithoClast®, Lithotrite, PCNL, Technology, Trilogy, Urolithiasis, Adolescent, Adult, Aged, Aged, 80 and over, Equipment Design, Female, Humans, Kidney Calculi, Male, Middle Aged, Nephrolithotomy, Percutaneous, Prospective Studies, Treatment Outcome, Young Adult

Journal Title

World J Urol

Conference Name

Journal ISSN

0724-4983
1433-8726

Volume Title

Publisher

Springer Science and Business Media LLC