Abstract
Purpose
Several energy sources are available to clear stones during PCNL. Required improvements are faster stone clearance, optimized suction and ease of use while maintaining high patient safety standard. EMS LithoClast® Trilogy, is the first device combining electromagnetic impactor with ultrasonic energy and suction, all-in-one probe. Animal studies and in vitro phantom stone studies have proven safety and efficacy of this device. We aim to study safety and clinical efficacy of Trilogy in our patients.
Methods
31 patients with renal stones were included. Amplatz sheath sizes/Trilogy probe size was 22–28 Fr/10.2 Fr for standard PNL (n = 20) and 15 Fr./5.7 Fr for mini PNL access (n = 11). Analysis was done with respect to demography, stone characteristics, operation duration (total time and lithotripter activation time), post op Hb drop, clearance rate and adverse events. Stone area/volume was calculated based on CT using 3D doctor. Efficacy was determined by stone volume clearance rate (mm3/min).
Results
Male:female ratio was 6:5 and 16:4 for mini (MPNL)/standard PNL (SPNL). Stone densities were 1229 ± 206 vs. 1168 ± 344 HU (MPNL vs. SPNL). Mean stone volumes were 3776.1 ± 2132 mm3 for MPNL and 7096 ± 6441 for SPNL. Mean stone volume clearance ratios were 370.5 ± 171 mm3/min and 590.7 ± 250mm3/min for MPNL and SPNL, respectively. Hb drop was 1.24 ± 0.64 g/dL (MPNL) and 1.23 ± 0.89gm/dL (SPNL). Total procedure time/lithotripter activation time was 53.4 ± 23.8/14.7 ± 12.4 min for MPNL and 65.2 ± 23.5/12.0 ± 8.9 for SPNL. Immediate post-operative/1 month stone clearance rates were 93%/96% with one clinically insignificant residual fragment (< 3 mm) and no necessity for auxiliary procedures. No device failure occured and three Clavien grade I and one grade II complications were observed.
Conclusion
Swiss LithoClast® Trilogy provides fast stone clearance in standard/mini-PCNL procedures. Ease of use, high tissue safety and optimized suction that avoids fragment blockings are other key features.
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Acknowledgements
The authors thank EMS Company for their support and Mr. Wolfgang Merkle for his technical support.
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RBS—protocol/project development, data collection or management, data analysis, manuscript writing/editing. SSB—protocol/project development, data collection or management, data analysis, manuscript writing/editing. PLS—data collection or management, data analysis. RS—data collection or management, data analysis. MV—data collection or management, data analysis, manuscript writing/editing. AGS—data collection or management, data analysis, manuscript writing/editing. APG—data analysis, manuscript writing/editing. MRD—data analysis, manuscript writing/editing.
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This study involves human subjects, after proper Institutional ethical committee presentation and clearance. The study has been performed in accordance with the ethical standards as laid down in the 1964 Declaration of Helsinki and its later amendments or comparable ethical standards.
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Sabnis, R.B., Balaji, S.S., Sonawane, P.L. et al. EMS Lithoclast Trilogy™: an effective single-probe dual-energy lithotripter for mini and standard PCNL. World J Urol 38, 1043–1050 (2020). https://doi.org/10.1007/s00345-019-02843-2
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DOI: https://doi.org/10.1007/s00345-019-02843-2