| Abstract: |
Objective: We estimated the potential outcomes, costs, and cost-effectiveness of the Vortex shunt, a novel fetal vesicoamniotic shunt (VAS), compared to standard shunts for treating fetal lower urinary tract obstruction (LUTO). Method: We designed a decision-analytic model comparing the Vortex shunt to current shunts using a theoretical cohort of 1000 pregnancies equivalent to the annual U.S. LUTO cases. Current literature indicates a 50% dislodgement risk and a 36% end-stage renal disease (ESRD) probability for current shunts versus the Vortex shunt's expected 10% dislodgement risk and 18% ESRD rate from pre-clinical studies. Outcomes included preterm delivery, preterm premature rupture of membrane (PPROM), ESRD, neurodevelopmental delay (NDD), neonatal death, costs, and quality-adjusted life years (QALYs). We derived model inputs from the literature and conducted sensitivity analyses. Results: Of 1000 theoretical LUTO pregnancies, the Vortex shunt resulted in 70 fewer cases of ESRD, 110 fewer preterm deliveries, 50 fewer episodes of PPROM, and 10 fewer children with NDD. The Vortex shunt was the dominant strategy with higher QALYs and estimated lifetime savings of $168,520 for each fetus undergoing VAS. The Vortex shunt was cost-effective 98% of the time. Conclusion: Our theoretical model suggests that the Vortex shunt is cost-effective compared to current shunts. © 2024 John Wiley & Sons Ltd. |
