A prospective, randomized, multicenter trial of amnioreduction vs selective fetoscopic laser photocoagulation for the treatment of severe twin-twin transfusion syndrome

OBJECTIVE: The objective of the study was to examine the effect of selective fetoscopic laser photocoagulation ( SFLP) vs serial amnioreduction ( AR) on perinatal mortality in severe twin- twin transfusion syndrome ( TTTS). STUDY DESIGN: This was a 5 year multicenter, prospective, randomized controlled trial. The primary outcome variable was 30 day postnatal survival of donors and recipients. RESULTS: There was no statistically significant difference in 30- day postnatal survival between SFLP or AR treatment for donors at 55% ( 11 of 20) vs 55% ( 11 of 20) ( P = 1.0, odds ratio [ OR] 1, 95% confidence interval [ Cl] 0.242 to 4.14) or recipients at 30% ( 6 of 20) vs 45% ( 9 of 20) ( P =.51, OR 1.88, 95% Cl 0.44 to 8.64). There was no difference in 30 day survival of 1 or both twins on a per- pregnancy basis between AR at 75% ( 15 of 20) and SFLP at 65% ( 13 of 20) ( P =.73, OR 1.62, 95% Cl 0.34 to 8.09). Overall survival (newborns divided by the number of fetuses treated) was not statistically significant for AR at 60% ( 24 of 40) vs SFLP 45% ( 18 of 40) ( P =.18, OR 2.01, 95% Cl 0.76 to 5.44). There was a statistically significant increase in fetal recipient mortality in the SFLP arm at 70% ( 14 of 20) vs the AR arm at 35% ( 7 of 20) ( P =.25, OR 5.31, 95% Cl 1.19 to 27.6). This was offset by increased recipient neonatal mortality of 30% ( 6 of 20) in the AR arm. Echocardiographic abnormality in recipient twin Cardiovascular Profile Score is the most significant predictor of recipient mortality ( P =.055, OR 3.025/ point) by logistic regression analysis. CONCLUSION: The outcome of the trial did not conclusively determine whether AR or SFLP is a superior treatment modality. TTTS cardiomyopathy appears to be an important factor in recipient survival in TTTS.