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

Timothy M. Crombleholme, David Shera, Hanmin Lee, Mark Johnson, Mary D'Alton, Flint Porter, Jacquelyn Chyu, Richard Silver, Alfred Abuhamad, George Saade, Laurence Shields, David Kauffman, Joanne Stone, Craig T. Albanese, Ray Bahado-Singh, Robert H. Ball, Larissa Bilaniuk, Beverly Coleman, Diana Farmer, Vickie FeldsteinMichael R. Harrison, Holly Hedrick, Jeffrey Livingston, Robert P. Lorenz, David A. Miller, Mary E. Norton, William J. Polzin, Julian N. Robinson, Jack Rychik, Per L. Sandberg, Istvan Seri, Erin Simon, Lynn L. Simpson, Larisa Yedigarova, R. Douglas Wilson, Bruce Young

Research output: Contribution to journalArticle

113 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
JournalAmerican Journal of Obstetrics and Gynecology
Volume197
Issue number4
DOIs
StatePublished - Oct 2007

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Fetofetal Transfusion
Light Coagulation
Multicenter Studies
Lasers
Odds Ratio
Confidence Intervals
Therapeutics
Fetal Mortality
Perinatal Mortality
Infant Mortality
Cardiomyopathies
Fetus
Randomized Controlled Trials
Logistic Models
Regression Analysis
Pregnancy
Mortality

Keywords

  • amnioreduction
  • selective fetoscopic laser photocoagulation
  • twin-twin transfusion syndrome

ASJC Scopus subject areas

  • Medicine(all)
  • Obstetrics and Gynecology

Cite this

A prospective, randomized, multicenter trial of amnioreduction vs selective fetoscopic laser photocoagulation for the treatment of severe twin-twin transfusion syndrome. / Crombleholme, Timothy M.; Shera, David; Lee, Hanmin; Johnson, Mark; D'Alton, Mary; Porter, Flint; Chyu, Jacquelyn; Silver, Richard; Abuhamad, Alfred; Saade, George; Shields, Laurence; Kauffman, David; Stone, Joanne; Albanese, Craig T.; Bahado-Singh, Ray; Ball, Robert H.; Bilaniuk, Larissa; Coleman, Beverly; Farmer, Diana; Feldstein, Vickie; Harrison, Michael R.; Hedrick, Holly; Livingston, Jeffrey; Lorenz, Robert P.; Miller, David A.; Norton, Mary E.; Polzin, William J.; Robinson, Julian N.; Rychik, Jack; Sandberg, Per L.; Seri, Istvan; Simon, Erin; Simpson, Lynn L.; Yedigarova, Larisa; Wilson, R. Douglas; Young, Bruce.

In: American Journal of Obstetrics and Gynecology, Vol. 197, No. 4, 10.2007.

Research output: Contribution to journalArticle

Crombleholme, TM, Shera, D, Lee, H, Johnson, M, D'Alton, M, Porter, F, Chyu, J, Silver, R, Abuhamad, A, Saade, G, Shields, L, Kauffman, D, Stone, J, Albanese, CT, Bahado-Singh, R, Ball, RH, Bilaniuk, L, Coleman, B, Farmer, D, Feldstein, V, Harrison, MR, Hedrick, H, Livingston, J, Lorenz, RP, Miller, DA, Norton, ME, Polzin, WJ, Robinson, JN, Rychik, J, Sandberg, PL, Seri, I, Simon, E, Simpson, LL, Yedigarova, L, Wilson, RD & Young, B 2007, 'A prospective, randomized, multicenter trial of amnioreduction vs selective fetoscopic laser photocoagulation for the treatment of severe twin-twin transfusion syndrome', American Journal of Obstetrics and Gynecology, vol. 197, no. 4. https://doi.org/10.1016/j.ajog.2007.07.020
Crombleholme, Timothy M. ; Shera, David ; Lee, Hanmin ; Johnson, Mark ; D'Alton, Mary ; Porter, Flint ; Chyu, Jacquelyn ; Silver, Richard ; Abuhamad, Alfred ; Saade, George ; Shields, Laurence ; Kauffman, David ; Stone, Joanne ; Albanese, Craig T. ; Bahado-Singh, Ray ; Ball, Robert H. ; Bilaniuk, Larissa ; Coleman, Beverly ; Farmer, Diana ; Feldstein, Vickie ; Harrison, Michael R. ; Hedrick, Holly ; Livingston, Jeffrey ; Lorenz, Robert P. ; Miller, David A. ; Norton, Mary E. ; Polzin, William J. ; Robinson, Julian N. ; Rychik, Jack ; Sandberg, Per L. ; Seri, Istvan ; Simon, Erin ; Simpson, Lynn L. ; Yedigarova, Larisa ; Wilson, R. Douglas ; Young, Bruce. / A prospective, randomized, multicenter trial of amnioreduction vs selective fetoscopic laser photocoagulation for the treatment of severe twin-twin transfusion syndrome. In: American Journal of Obstetrics and Gynecology. 2007 ; Vol. 197, No. 4.
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abstract = "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.",
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T1 - A prospective, randomized, multicenter trial of amnioreduction vs selective fetoscopic laser photocoagulation for the treatment of severe twin-twin transfusion syndrome

AU - Crombleholme, Timothy M.

AU - Shera, David

AU - Lee, Hanmin

AU - Johnson, Mark

AU - D'Alton, Mary

AU - Porter, Flint

AU - Chyu, Jacquelyn

AU - Silver, Richard

AU - Abuhamad, Alfred

AU - Saade, George

AU - Shields, Laurence

AU - Kauffman, David

AU - Stone, Joanne

AU - Albanese, Craig T.

AU - Bahado-Singh, Ray

AU - Ball, Robert H.

AU - Bilaniuk, Larissa

AU - Coleman, Beverly

AU - Farmer, Diana

AU - Feldstein, Vickie

AU - Harrison, Michael R.

AU - Hedrick, Holly

AU - Livingston, Jeffrey

AU - Lorenz, Robert P.

AU - Miller, David A.

AU - Norton, Mary E.

AU - Polzin, William J.

AU - Robinson, Julian N.

AU - Rychik, Jack

AU - Sandberg, Per L.

AU - Seri, Istvan

AU - Simon, Erin

AU - Simpson, Lynn L.

AU - Yedigarova, Larisa

AU - Wilson, R. Douglas

AU - Young, Bruce

PY - 2007/10

Y1 - 2007/10

N2 - 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.

AB - 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.

KW - amnioreduction

KW - selective fetoscopic laser photocoagulation

KW - twin-twin transfusion syndrome

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