Expert review of medical devices · 2025
Post-operative infection with a single-use ureteroscope with real-time intrarenal pressure monitoring vs. all other single-use ureteroscopes.
Сравнительное исследованиеСтатьяНазвание и аннотация: Перевод в очереди
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Bhojani Naeem, Morris Kathryn, White Jenifer, Rojanasarot Sirikan, Tran Emma D, Monga Manoj
Аннотация
BACKGROUND: Evidence for LithoVue™ Elite Single-Use Digital Flexible Ureteroscope (LVE) with pressure monitoring vs. other single-use ureteroscopes is needed.
RESEARCH DESIGN AND METHODS: This study using US electronic health records evaluated patients undergoing ureteroscopy (URS) with laser lithotripsy between 1 January 2023 and 1 June 2025. The primary endpoint was post-operative infection, defined as urinary tract infection (UTI), sepsis, and other infections, assessed at 10- and 30-days post-index procedure. Propensity score matching controlled for baseline differences.
RESULTS: After matching, 208 patients with LVE with pressure monitoring (mean age 61.4; 48.1% female; 79.3% White) and 416 with other single-use ureteroscopes without pressure monitoring (mean age 61.8; 48.1% female; 78.1% White) were evaluated. Post-operative LVE with pressure monitoring infection was significantly lower at 30 days post-index (8.2% vs. 15.4%; p = 0.016). Multivariable analyses confirmed significantly higher odds of 30-day infection with other single-use ureteroscopes (odds ratio 2.09 [95% confidence interval 1.19-3.86]; p = 0.014). Post-operative sepsis and other infections did not statistically differ; however, post-operative 30-day UTI was significantly less with LVE with pressure monitoring (5.2% vs. 10.8%; p = 0.033).
CONCLUSIONS: LVE with pressure monitoring was associated with reduced 30-day post-URS infection. These findings support clinical improvement with LVE and suggest that intrarenal pressure monitoring may contribute to better short-term outcomes.
RESEARCH DESIGN AND METHODS: This study using US electronic health records evaluated patients undergoing ureteroscopy (URS) with laser lithotripsy between 1 January 2023 and 1 June 2025. The primary endpoint was post-operative infection, defined as urinary tract infection (UTI), sepsis, and other infections, assessed at 10- and 30-days post-index procedure. Propensity score matching controlled for baseline differences.
RESULTS: After matching, 208 patients with LVE with pressure monitoring (mean age 61.4; 48.1% female; 79.3% White) and 416 with other single-use ureteroscopes without pressure monitoring (mean age 61.8; 48.1% female; 78.1% White) were evaluated. Post-operative LVE with pressure monitoring infection was significantly lower at 30 days post-index (8.2% vs. 15.4%; p = 0.016). Multivariable analyses confirmed significantly higher odds of 30-day infection with other single-use ureteroscopes (odds ratio 2.09 [95% confidence interval 1.19-3.86]; p = 0.014). Post-operative sepsis and other infections did not statistically differ; however, post-operative 30-day UTI was significantly less with LVE with pressure monitoring (5.2% vs. 10.8%; p = 0.033).
CONCLUSIONS: LVE with pressure monitoring was associated with reduced 30-day post-URS infection. These findings support clinical improvement with LVE and suggest that intrarenal pressure monitoring may contribute to better short-term outcomes.