EDAP International (Cambridge, Massachusetts) has developed a new piez
oelectric lithotripter (LT.02) that differs from their earlier model (
LT.01) in two important respects: method of stone visualization and av
ailable power. The LT.02 provides both in-line fluoroscopy as well as
real time ultrasound. The maximum energy is 1400 Bar (compared with 11
00 Bar in the LT.01). The purpose of this study was to determine wheth
er treatment with the EDAP LT.02 piezoelectric lithotripter would caus
e significant renal injury in minipigs. Accordingly, 18 minipigs were
divided into 3 groups of 6. Each group received a treatment of 20, 40,
or 60 minutes; the power level and shock wave frequency were kept at
maximal levels throughout the treatment period. Three pigs from each g
roup were sacrificed at 72 hours (acute). The remaining 9 pigs were sa
crificed 1 month following LT.02 treatment (chronic). Histopathologic
analysis of the treated kidney revealed that 33% of the 9 acute pigs d
eveloped a small capsular hematoma, whereas 66% showed only a small pa
renchymal contusion (less than or equal to 1% of total renal volume).
Among the chronic pigs, 66% had a small cortical scar, whereas 33% had
no macroscopic pathology. Despite the differences in the number of sh
ock waves delivered, these changes were evenly distributed among the 3
groups. Histologic acute changes included circumscribed areas of hemo
rrhagic infarction, vascular thrombosis with recanalization and focal
tubular obstruction and damage. At 30 days, however, these acute injur
ies had completely resolved in 3 pigs and were only notable as minute
areas of focal tubular loss in 6 pigs.