Systematic review and meta-analysis reports TFL lithotripsy complication rates in urolithiasis

BACKGROUND: Thulium Fiber Laser (TFL) has emerged as a promising alternative to Holmium: YAG for lithotripsy, yet its safety profile remains fragmented across various trials. This study aims to synthesize available evidence to determine the pooled complication rates associated with TFL lithotripsy . METHODS: A systematic review was conducted following PRISMA guidelines. We searched PubMed, Cochrane CENTRAL, and ClinicalTrials.gov for studies reporting complications of TFL in adult patients with urolithiasis. The primary outcome was the overall complication rate. Secondary outcomes included Clavien-Dindo grading, specific adverse events (fever, sepsis, injury), and stone-free rate (SFR). A random-effects meta-analysis was performed using the Freeman-Tukey double-arcsine transformation. RESULTS: Thirty-eight studies involving 3,329 patients were included. The pooled overall complication rate was 10.42% (95% CI: 8.01%-13.10%; I²=81.9%). Major complications (Clavien-Dindo III-V) were rare, with a pooled rate of 1.19% (95% CI: 0.68%-1.84%). Specific event rates included fever (2.45%), ureteral injury (1.37%), bleeding (1.07%), urosepsis (0.77%), ureteral strictures (0.70) and acute pyelonephritis (0.59%). Meta-regression identified operative time as a significant predictor of complications (p = 0.041), whereas stone size was not (p = 0.358). Subgroup analysis showed higher complication rates in pure renal stone treatments (13.83%) compared to ureteral stones (10.64%). The pooled Stone-Free Rate (SFR) was 87.61% (95% CI: 83.61%-91.12%). CONCLUSION: Thulium Fiber Laser lithotripsy demonstrates a pretty favorable safety profile with a very low incidence of high-grade complications (< 1.2%) and high efficacy.