Clinical Trial of Amnioreduction vs Selective Fetoscopic Laser Photocoagulation

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Abstract

Objective: A prospective randomized clinical trial was conducted to determine if survival is better in patients treated with selective fetoscopic laser photocoagulation (SFLP) vs amnioreduction (AR) in a highly select population with TTTS which fail to respond to qualifying amnioreduction.

Study Design: Subjects meeting all inclusion and exclusion criteria were offered randomization to either serial AR (17 centers) or SFLP (3 centers). Treatment failure was defined as development or progression of hydrops, or severe cardiac decompensation despite treatment. For each twin, the primary outcome variable was the 30 day postnatal survival, without treatment failure.

Results: A total of 196 patients were screened 254 times and of those 42 were randomized to either AR (21) or SFLP (21). There was no significant difference on the primary outcome for either recipients (45% vs 30%, p=NS) or donors (55% vs 55%). There was no significant difference in 30 day survival of one or both twins between AR and SFLP (75% vs 65% p=NS). There was no significant difference in overall 30 day survival between AR and SFLP (60% vs 43% p=NS). There was a statistically significant increased fetal survival among recipient twins treated by AR vs SFLP (75% vs 35% p<0.025). Within stages III and IV there was a significant difference in 30 day survival for AR vs SFLP (67% vs 12.5%, p<0.03). There were more in treatment failures in AR vs SFLP (4 vs 0) resulting in no significant overall differences between the treatment arms at 30 days.

Conclusion: There is no significant difference in survival between AR and SFLP, but in stages III and IV, SFLP is associated with a lower recipient survival. Intervention before TTTS becomes advanced may be necessary to improve survival.

References:

0002-9378/$ - see front matter

doi:10.1016/j.ajog.2006.10.053

American Journal of Obstetrics and Gynecology

Volume 195, Issue 6, Supplement S (December 2006)