Could Use of a Flexible and Navigable Suction Ureteral Access Sheath Be a Potential Game-changer in Retrograde Intrarenal Surgery? Outcomes at 30 Days from a Large, Prospective, Multicenter, Real-world Study by the European Association of Urology Urolithiasis Section.

Abstract

Background and objective: The aim of this study was to evaluate the stone-free status (SFS) rate and complications after flexible ureteroscopy (fURS) for treatment of renal stones using a flexible and navigable suction (FANS) ureteral access sheath.

Methods: Data for adults undergoing fURS in 25 centers worldwide were prospectively collected (August 2023 to January 2024). Exclusion criteria were abnormal renal anatomy and ureteral stones. All patients had computed tomography scans before and within 30 d after fURS with a FANS ureteral access sheath. SFS was defined as follows: grade A, zero fragments; grade B, a single fragment ≤2 mm; grade C, a single fragment 2.1-4 mm; and grade D, single/multiple fragments >4 mm. Data for continuous variables are presented as the median and interquartile range (IQR). Multivariable logistic regression was performed to evaluate predictors of grade A SFS.

Key findings and limitations: The study enrolled 394 patients (59.1% male) with a median age of 49 yr (IQR 36-61). The median stone volume was 1260 mm³ (IQR 706-1800). Thulium fiber laser (TFL) was used in 45.9% of cases and holmium laser in the rest. The median lasing time was 18 min (IQR 11-28) and the median operative time was 49 min (IQR 37-70). One patient required a blood transfusion and 3.3% of patients had low-grade fever. No patient developed sepsis. Low-grade ureteral injury occurred in eight patients (2%). The grade A SFS rate was 57.4% and the grade A + B SFS rate was 97.2%, while 2.8% of patients had grade C or D SFS. Eleven patients underwent repeat fURS. Multivariable analysis revealed that a stone volume of 1501-3000 mm³ (odds ratio 0.50) and of >3000 mm³ (odds ratio 0.29) were significantly associated with lower probability of grade A SFS, while TFL use was associated with higher SFS probability (odds ratio 1.83). Limitations include the lack of a comparative group.

Conclusions and clinical implications: fURS using a FANS ureteral access sheath resulted in a high SFS rate with negligible serious adverse event and reintervention rates.

Patient summary: We looked at 30-day results for patients undergoing telescopic laser treatment for kidney stones using a special type of vacuum-assisted sheath to remove stone fragments. We found a high stone-free rate with minimal complications.