MP22-11: The efficacy and safety of the EMS Lithoclast Trilogy: a European multicenter prospective study on behalf of ESUT
Friday, May 15, 2020
7:00 AM – 9:00 AM
Oliver Wiseman, Florin Tanse, Kasra Saeb-Parsy, Nabil Atassi, Renate Endriss, Laurian Dragos, Guido Kamphuis, Daniel Pèrez Fentes , Mudhar Hassan, Marianne Brehmer, Osther Palle, Helene Jung, Ben Turney, William Finch, Neil Burgess, Stuart Irving, Evangelos Liatsikos, Thomas Knoll, Victor Cauni
Introduction: PCNL requires a lithotrite to efficiently break and remove stones. We set out to determine the efficacy and safety of a new lithotrite, the EMS Lithoclast Trilogy, in the first reported prospective European multicentre evaluation. We compare it to published clinical stone clearance rates based on surface area for other lithotrites (24-32.3 mm2/min), and using the 3D calculated stone volume, to the single published series for the Lithoclast Trilogy (591mm3/min).
Methods: A total of 10 European centres took part in this prospective non-randomised study. Objective measures of stone clearance rate, device malfunction, stone-free rate, and complications were assessed. Each surgeon evaluated subjective parameters, including ergonomic and device effectiveness, for each case, on a 1-10 scale (10 = extremely ergonomic / effective), and compared it to their usual lithotrite on a 1-10 scale (10 = extremely effective).
Results: 53 patients undergoing PCNL were included. The mean stone clearance rate was 58mm2/minute, or 1202 mm3/minute based on calculated 3D stone volume. The stone-free rate on fluoroscopy screening at the end of the case was 75%. Long term follow up is awaited.
The subjective surgeon feedback for ergonomic score was 8.2, the least satisfactory element. The highest feedback was for suction effectiveness at 9.4, with 9.3 for combination effectiveness and 9.13 for overall effectiveness compared to lithotrite most commonly used previously.
Three patients required a blood transfusion, two patients developed post-op sepsis, two required subsequent JJ stent placement, and one patient had a prolonged bleed from a subcutaneous vessel. Five cases experienced a probe breakage, and there were two other device related complications, none of which required using a different lithotrite.
Conclusions: This multicentre prospective study has demonstrated that the new Lithoclast Trilogy is highly effective at stone removal. The stone removal efficiency of Trilogy is almost 100% greater compared to published data on other Lithotrites. In addition, comparing stone removal based on volume, it is over twice as effective as in the single published study on Swiss Lithoclast Trilogy.
The device was perceived by surgeons to be highly effective overall and compared to the most commonly used previous lithotrite. The probe breakage rate was 9%, which may represent the learning curve of lack of familiarity with a new device, or may suggest that manufacturing or control box parameters require modifications. Source of
Funding: This study was supported by a grant from EMS.