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Volume 197, Issue 4, Pages 396.e1-396.e9 (October 2007)


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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.

Timothy M. Crombleholme, MDaCorresponding Author Informationemail address, David Shera, ScDb, Hanmin Lee, MDc, Mark Johnson, MDb, Mary D’Alton, MDd, Flint Porter, MDe, Jacquelyn Chyu, MDf, Richard Silver, MDh, Alfred Abuhamad, MDg, George Saade, MDi, Laurence Shields, MDj, David Kauffman, MDk, Joanne Stone, MDl, Craig T. Albanese, MDc, Ray Bahado-Singh, MDa, Robert H. Ball, MDe, Larissa Bilaniuk, MDb, Beverly Coleman, MDm, Diana Farmer, MDc, Vickie Feldstein, MDc, Michael R. Harrison, MDc, Holly Hedrick, MDb, Jeffrey Livingston, MDa, Robert P. Lorenz, MDn, David A. Miller, MDo, Mary E. Norton, MDc, William J. Polzin, MDa, Julian N. Robinson, MDd, Jack Rychik, MDb, Per L. Sandberg, MDc, Istvan Seri, MDb, Erin Simon, MDb, Lynn L. Simpson, MDd, Larisa Yedigarova, MDo, R. Douglas Wilson, MDb, Bruce Young, MDp

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.

a Fetal Care Center of Cincinnati (Cincinnati Children’s Hospital Medical Center, Good Samaritan Hospital, University Hospital, and the University of Cincinnati College of Medicine), Cincinnati, OH

b Children’s Hospital of Philadelphia, Philadelphia, PA

c University of California–San Francisco, San Francisco, CA

d Columbia–Presbyterian Medical Center, New York, NY

e University of Utah Hospital, Salt Lake City, UT

f University of Colorado Health Sciences Center, Denver, CO

g Evanston Northwestern Healthcare, IL

h Eastern Virginia Medical School, Norfolk, VA

i University of Texas Medical Branch, Galveston, TX

j University of Washington Medical Center, Seattle, WA

k Magee–Women’s Hospital, Pittsburgh, PA

l Mount Sinai Medical Center, New York, NY

m Hospital of the University of Pennsylvania, Philadelphia, PA

n William Beaumont Hospital, Royal Oak, MI

o Queen of Angels–Hollywood Presbyterian Medical Center, Los Angeles, CA

p New York University School of Medicine, New York, NY.

Corresponding Author InformationReprints: Timothy M. Crombleholme, MD, The Fetal Care Center of Cincinnati, Division of Pediatric General, Thoracic, and Fetal Surgery, Cincinnati Children’s Hospital, MLC #2023, 3333 Burnet Avenue, Cincinnati, OH 45229

 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.

PII: S0002-9378(07)00888-5

doi:10.1016/j.ajog.2007.07.020


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