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

Presented at the 27th Annual Clinical Meeting of the Society for Maternal-Fetal Medicine, San Francisco, CA, Feb. 5-10, 2007.
https://doi.org/10.1016/j.ajog.2007.07.020Get rights and content

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 [CI] 0.242 to 4.14) or recipients at 30% (6 of 20) vs 45% (9 of 20) (P = .51, OR 1.88, 95% CI 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% CI 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% CI 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% CI 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.

Section snippets

Study design

This trial was a 5 year multicenter, prospective, randomized, controlled trial to examine the effect of SFLP, compared with serial AR, on perinatal mortality in severe TTTS. Patients meeting entry criteria (see Table) and consenting to enter the trial were randomized to 1 of the 2 treatment arms with equal likelihood.

Primary and secondary outcomes

The primary outcome variable to be assessed in this trial comparing AR with SFLP was the 30 day neonatal survival of donors and recipients. In addition, secondary outcome variables

Results

The study was stopped early, after 42 subjects were randomized, at the request of the investigators. Referring physicians were increasingly unwilling to refer eligible subjects for evaluation to participating centers in which SFLP was available only through randomization in the trial. At the same time that the investigators’ meeting was held to decide to stop the trial, the Trial Oversight Committee, charged with evaluating all adverse events and serious adverse events, detected a statistical

Comment

The results of this trial show no statistically significant difference in overall neonatal survival to 30 days of life or neonatal survival of 1 or both twins in the same pregnancy in cases of severe TTTS treated by either AR or SFLP. Despite these overall results, there is a statistically significantly worse fetal survival observed among recipient twins in pregnancies treated by SFLP, compared with those treated by AR. This apparent conundrum can be accounted for by recipient fetal losses in

Acknowledgments

The authors gratefully acknowledge the expert technical assistance of the following:

The Children’s Hospital of Philadelphia

Victoria Shokrollah, MT, trial coordinator

Roberta Ballard, MD, consultant

Lori J. Howell, RN, MS, study coordinator

Jamie Koh, study coordinator

Joy Macdonald, RN, study coordinator

Joy N. Williams, RN, BSN, study coordinator

Cincinnati Children’s Hospital Medical Center

Kim Lyons, RN, BSN, CCRC, trial coordinator,

Jennifer L. Mason, RN, BSN, study coordinator

Columbia-Presbyterian

References (42)

  • G. Mari et al.

    Perinatal morbidity and mortality rates in severe twin-twin transfusion syndromeResults of the international amnioreduction registry

    Am J Obstet Gynecol

    (2001)
  • J.E. Dickinson et al.

    Obstetric and perinatal outcomes from the Australian and New Zealand twin-twin transfusion syndrome registry

    Am J Obstet Gynecol

    (2000)
  • U.F. Harkness et al.

    Twin-twin transfusion syndrome: where do we go from here?

    Semin Perinatol

    (2005)
  • P.E. Weir et al.

    Acute polyhydramnios—a complication of monozygous twin pregnancy

    Br J Obstet Gynaecol

    (1979)
  • L.H. Steinberg et al.

    Acute polyhydramnios in twin pregnancies

    Austral N Z. J Obstet Gynecol

    (1990)
  • N.C. Cheschier et al.

    Polyhydramnios and oligohydramnios in twin gestations

    Obstet Gynecol

    (1988)
  • N.J. Saunders et al.

    Twin-twin transfusion syndrome during the 2nd trimester is associated with small intertwin haemoglobin differences

    Fetal Diag Ther

    (1991)
  • T.L. Callahan et al.

    The economic impact of multiple-gestation pregnancies and the contribution of assisted-reproduction techniques to their incidence

    N Engl J Med

    (1994)
  • K.J. Moise

    Polyhydramnios: problems and treatment

    Sem Perinatol

    (1993)
  • A. Rodestal et al.

    Acute polyhydramnios in twin pregnancyA retrospective study with special reference to therapeutic amniocentesis

    Acta Obstet Gynecol Scand

    (1990)
  • J.P. Elliott et al.

    Aggressive therapeutic amniocentesis for treatment of twin-twin transfusion syndrome

    Obstet Gynecol

    (1991)
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    This work was supported in part by Grant R01 HD41149 from the National Institute of Child Health and Human Development (to T.M.C.). Statistical work was supported in part by National Institute of Child Health and Human Development, Mental Retardation Developmental Disabilities Research Center at Children’s Hospital of Philadelphia, Grant 3P30 HD26979-04S2 (to D.S.).

    Cite this article as: Crombleholme TM, Shera D, Lee H, et al. A prospective, randomized, multicenter trial of amnioreduction vs selective fetoscopic laser photocoagulation for the treatment of severe twin-twin transfusion syndrome. Am J Obstet Gynecol 2007;197:396.e1-396.e9.

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