Evidence map›Paper›PMID 24705119›Full record

Trial reportCirculation2014

Transplantation-free survival and interventions at 3 years in the single ventricle reconstruction trial.

Jane W Newburger, Lynn A Sleeper, Peter C Frommelt, Gail D Pearson, William T Mahle, Shan Chen, Carolyn Dunbar-Masterson, Seema Mital, Ismee A Williams, Nancy S Ghanayem and 12 more

Registry-linked trialOpen access · bronzeAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Circulation, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00115934 (Trial of Right Ventricular Versus Modified Blalock-Taussig Shunt in Infants With Single Ventricle Defect Undergoing Staged Reconstruction), which is not on this map. Cited by 72 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
72citing papers in PubMed, 2 pooled it
24.1field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00115934 nacompletednot on this map

Trial of Right Ventricular Versus Modified Blalock-Taussig Shunt in Infants With Single Ventricle Defect Undergoing Staged Reconstruction (A Trial Conducted by the Pediatric Heart Network)

TypeinterventionalSponsorCarelon ResearchRan2005 to 2009Enrolled555ConditionsHeart Defects, CongenitalArmsBlalock-Taussig pulmonary artery shunt, Right ventricular to pulmonary artery shunt
3 · Its place in the literature

Who cites it

72 citing papers in PubMed, 2 syntheses or guidelines pooled it, 202 citations in OpenAlex.

  1. Pooled it
  2. Randomized controlled trials in children's heart surgery in the 21st century: a systematic review.European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery · 2018
    Pooled it
  3. Trial
  4. Trial
  5. Trial
  6. Trial
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  10. Impact of initial norwood shunt type on right ventricular deformation: the single ventricle reconstruction trial.Journal of the American Society of Echocardiography : official publication of the American Society of Echocardiography · 2015
    Trial
  11. Trial
  12. Article
  13. Is There a Unified Etiology of Hypoplastic Left Heart Syndrome? Evaluating Genetic, Structural, and Hemodynamic Models of Disease Initiation.Pathophysiology : the official journal of the International Society for Pathophysiology · 2026
    Review
  14. Article
  15. Transcatheter fenestration in Fontan failure: Our clinical experience.Turk gogus kalp damar cerrahisi dergisi · 2025
    Article
  16. Article
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  18. Article
  19. Review
  20. Article

12 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

22 authors at 1 institution in 1 country.

Jane W NewburgerFrom the Boston Children's Hospital and Harvard Medical School, Boston, MA (J.W.N., C.D.-M.); New England Research Institutes, Watertown, MA (L.A.S., S.C.); Children's Hospital of Wisconsin and Medical College of Wisconsin, Milwaukee (P.C.F.); National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (G.D.P.); Emory University, Atlanta, GA (W.T.M.); Hospital for Sick Children, Toronto, ON, Canada (S.M., S.K.); Morgan Stanley Children's Hospital of New York-Presbyterian, New York (I.A.W.); University of Michigan Medical School, Ann Arbor (C.S.G., R.G.O.); The Congenital Heart Institute of Florida, St. Petersburg (J.P.J.); Cincinnati Children's Medical Center, Cincinnati, OH (C.D.K.); Children's Hospital Los Angeles, Los Angeles, CA (A.B.L.); North Carolina Consortium: Duke University, Durham; East Carolina University, Greenville; Wake Forest University, Winston-Salem (S.K.P.); Nemours Cardiac Center, Wilmington, DE (C.P.); Primary Children's Medical Center and University of Utah, Salt Lake City (P.J.G.); Medical University of South Carolina, Charleston (A.M.A.); and Children's Hospital of Philadelphia and University of Pennsylvania Medical School, Philadelphia (J.W.G.). jane.newburger@cardio.chboston.org.
Lynn A SleeperFrom the Boston Children's Hospital and Harvard Medical School, Boston, MA (J.W.N., C.D.-M.); New England Research Institutes, Watertown, MA (L.A.S., S.C.); Children's Hospital of Wisconsin and Medical College of Wisconsin, Milwaukee (P.C.F.); National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (G.D.P.); Emory University, Atlanta, GA (W.T.M.); Hospital for Sick Children, Toronto, ON, Canada (S.M., S.K.); Morgan Stanley Children's Hospital of New York-Presbyterian, New York (I.A.W.); University of Michigan Medical School, Ann Arbor (C.S.G., R.G.O.); The Congenital Heart Institute of Florida, St. Petersburg (J.P.J.); Cincinnati Children's Medical Center, Cincinnati, OH (C.D.K.); Children's Hospital Los Angeles, Los Angeles, CA (A.B.L.); North Carolina Consortium: Duke University, Durham; East Carolina University, Greenville; Wake Forest University, Winston-Salem (S.K.P.); Nemours Cardiac Center, Wilmington, DE (C.P.); Primary Children's Medical Center and University of Utah, Salt Lake City (P.J.G.); Medical University of South Carolina, Charleston (A.M.A.); and Children's Hospital of Philadelphia and University of Pennsylvania Medical School, Philadelphia (J.W.G.).
Peter C FrommeltFrom the Boston Children's Hospital and Harvard Medical School, Boston, MA (J.W.N., C.D.-M.); New England Research Institutes, Watertown, MA (L.A.S., S.C.); Children's Hospital of Wisconsin and Medical College of Wisconsin, Milwaukee (P.C.F.); National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (G.D.P.); Emory University, Atlanta, GA (W.T.M.); Hospital for Sick Children, Toronto, ON, Canada (S.M., S.K.); Morgan Stanley Children's Hospital of New York-Presbyterian, New York (I.A.W.); University of Michigan Medical School, Ann Arbor (C.S.G., R.G.O.); The Congenital Heart Institute of Florida, St. Petersburg (J.P.J.); Cincinnati Children's Medical Center, Cincinnati, OH (C.D.K.); Children's Hospital Los Angeles, Los Angeles, CA (A.B.L.); North Carolina Consortium: Duke University, Durham; East Carolina University, Greenville; Wake Forest University, Winston-Salem (S.K.P.); Nemours Cardiac Center, Wilmington, DE (C.P.); Primary Children's Medical Center and University of Utah, Salt Lake City (P.J.G.); Medical University of South Carolina, Charleston (A.M.A.); and Children's Hospital of Philadelphia and University of Pennsylvania Medical School, Philadelphia (J.W.G.).
Gail D PearsonFrom the Boston Children's Hospital and Harvard Medical School, Boston, MA (J.W.N., C.D.-M.); New England Research Institutes, Watertown, MA (L.A.S., S.C.); Children's Hospital of Wisconsin and Medical College of Wisconsin, Milwaukee (P.C.F.); National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (G.D.P.); Emory University, Atlanta, GA (W.T.M.); Hospital for Sick Children, Toronto, ON, Canada (S.M., S.K.); Morgan Stanley Children's Hospital of New York-Presbyterian, New York (I.A.W.); University of Michigan Medical School, Ann Arbor (C.S.G., R.G.O.); The Congenital Heart Institute of Florida, St. Petersburg (J.P.J.); Cincinnati Children's Medical Center, Cincinnati, OH (C.D.K.); Children's Hospital Los Angeles, Los Angeles, CA (A.B.L.); North Carolina Consortium: Duke University, Durham; East Carolina University, Greenville; Wake Forest University, Winston-Salem (S.K.P.); Nemours Cardiac Center, Wilmington, DE (C.P.); Primary Children's Medical Center and University of Utah, Salt Lake City (P.J.G.); Medical University of South Carolina, Charleston (A.M.A.); and Children's Hospital of Philadelphia and University of Pennsylvania Medical School, Philadelphia (J.W.G.).
William T MahleFrom the Boston Children's Hospital and Harvard Medical School, Boston, MA (J.W.N., C.D.-M.); New England Research Institutes, Watertown, MA (L.A.S., S.C.); Children's Hospital of Wisconsin and Medical College of Wisconsin, Milwaukee (P.C.F.); National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (G.D.P.); Emory University, Atlanta, GA (W.T.M.); Hospital for Sick Children, Toronto, ON, Canada (S.M., S.K.); Morgan Stanley Children's Hospital of New York-Presbyterian, New York (I.A.W.); University of Michigan Medical School, Ann Arbor (C.S.G., R.G.O.); The Congenital Heart Institute of Florida, St. Petersburg (J.P.J.); Cincinnati Children's Medical Center, Cincinnati, OH (C.D.K.); Children's Hospital Los Angeles, Los Angeles, CA (A.B.L.); North Carolina Consortium: Duke University, Durham; East Carolina University, Greenville; Wake Forest University, Winston-Salem (S.K.P.); Nemours Cardiac Center, Wilmington, DE (C.P.); Primary Children's Medical Center and University of Utah, Salt Lake City (P.J.G.); Medical University of South Carolina, Charleston (A.M.A.); and Children's Hospital of Philadelphia and University of Pennsylvania Medical School, Philadelphia (J.W.G.).
Shan ChenFrom the Boston Children's Hospital and Harvard Medical School, Boston, MA (J.W.N., C.D.-M.); New England Research Institutes, Watertown, MA (L.A.S., S.C.); Children's Hospital of Wisconsin and Medical College of Wisconsin, Milwaukee (P.C.F.); National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (G.D.P.); Emory University, Atlanta, GA (W.T.M.); Hospital for Sick Children, Toronto, ON, Canada (S.M., S.K.); Morgan Stanley Children's Hospital of New York-Presbyterian, New York (I.A.W.); University of Michigan Medical School, Ann Arbor (C.S.G., R.G.O.); The Congenital Heart Institute of Florida, St. Petersburg (J.P.J.); Cincinnati Children's Medical Center, Cincinnati, OH (C.D.K.); Children's Hospital Los Angeles, Los Angeles, CA (A.B.L.); North Carolina Consortium: Duke University, Durham; East Carolina University, Greenville; Wake Forest University, Winston-Salem (S.K.P.); Nemours Cardiac Center, Wilmington, DE (C.P.); Primary Children's Medical Center and University of Utah, Salt Lake City (P.J.G.); Medical University of South Carolina, Charleston (A.M.A.); and Children's Hospital of Philadelphia and University of Pennsylvania Medical School, Philadelphia (J.W.G.).
Carolyn Dunbar-MastersonFrom the Boston Children's Hospital and Harvard Medical School, Boston, MA (J.W.N., C.D.-M.); New England Research Institutes, Watertown, MA (L.A.S., S.C.); Children's Hospital of Wisconsin and Medical College of Wisconsin, Milwaukee (P.C.F.); National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (G.D.P.); Emory University, Atlanta, GA (W.T.M.); Hospital for Sick Children, Toronto, ON, Canada (S.M., S.K.); Morgan Stanley Children's Hospital of New York-Presbyterian, New York (I.A.W.); University of Michigan Medical School, Ann Arbor (C.S.G., R.G.O.); The Congenital Heart Institute of Florida, St. Petersburg (J.P.J.); Cincinnati Children's Medical Center, Cincinnati, OH (C.D.K.); Children's Hospital Los Angeles, Los Angeles, CA (A.B.L.); North Carolina Consortium: Duke University, Durham; East Carolina University, Greenville; Wake Forest University, Winston-Salem (S.K.P.); Nemours Cardiac Center, Wilmington, DE (C.P.); Primary Children's Medical Center and University of Utah, Salt Lake City (P.J.G.); Medical University of South Carolina, Charleston (A.M.A.); and Children's Hospital of Philadelphia and University of Pennsylvania Medical School, Philadelphia (J.W.G.).
Seema MitalFrom the Boston Children's Hospital and Harvard Medical School, Boston, MA (J.W.N., C.D.-M.); New England Research Institutes, Watertown, MA (L.A.S., S.C.); Children's Hospital of Wisconsin and Medical College of Wisconsin, Milwaukee (P.C.F.); National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (G.D.P.); Emory University, Atlanta, GA (W.T.M.); Hospital for Sick Children, Toronto, ON, Canada (S.M., S.K.); Morgan Stanley Children's Hospital of New York-Presbyterian, New York (I.A.W.); University of Michigan Medical School, Ann Arbor (C.S.G., R.G.O.); The Congenital Heart Institute of Florida, St. Petersburg (J.P.J.); Cincinnati Children's Medical Center, Cincinnati, OH (C.D.K.); Children's Hospital Los Angeles, Los Angeles, CA (A.B.L.); North Carolina Consortium: Duke University, Durham; East Carolina University, Greenville; Wake Forest University, Winston-Salem (S.K.P.); Nemours Cardiac Center, Wilmington, DE (C.P.); Primary Children's Medical Center and University of Utah, Salt Lake City (P.J.G.); Medical University of South Carolina, Charleston (A.M.A.); and Children's Hospital of Philadelphia and University of Pennsylvania Medical School, Philadelphia (J.W.G.).
Ismee A WilliamsFrom the Boston Children's Hospital and Harvard Medical School, Boston, MA (J.W.N., C.D.-M.); New England Research Institutes, Watertown, MA (L.A.S., S.C.); Children's Hospital of Wisconsin and Medical College of Wisconsin, Milwaukee (P.C.F.); National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (G.D.P.); Emory University, Atlanta, GA (W.T.M.); Hospital for Sick Children, Toronto, ON, Canada (S.M., S.K.); Morgan Stanley Children's Hospital of New York-Presbyterian, New York (I.A.W.); University of Michigan Medical School, Ann Arbor (C.S.G., R.G.O.); The Congenital Heart Institute of Florida, St. Petersburg (J.P.J.); Cincinnati Children's Medical Center, Cincinnati, OH (C.D.K.); Children's Hospital Los Angeles, Los Angeles, CA (A.B.L.); North Carolina Consortium: Duke University, Durham; East Carolina University, Greenville; Wake Forest University, Winston-Salem (S.K.P.); Nemours Cardiac Center, Wilmington, DE (C.P.); Primary Children's Medical Center and University of Utah, Salt Lake City (P.J.G.); Medical University of South Carolina, Charleston (A.M.A.); and Children's Hospital of Philadelphia and University of Pennsylvania Medical School, Philadelphia (J.W.G.).
Nancy S GhanayemFrom the Boston Children's Hospital and Harvard Medical School, Boston, MA (J.W.N., C.D.-M.); New England Research Institutes, Watertown, MA (L.A.S., S.C.); Children's Hospital of Wisconsin and Medical College of Wisconsin, Milwaukee (P.C.F.); National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (G.D.P.); Emory University, Atlanta, GA (W.T.M.); Hospital for Sick Children, Toronto, ON, Canada (S.M., S.K.); Morgan Stanley Children's Hospital of New York-Presbyterian, New York (I.A.W.); University of Michigan Medical School, Ann Arbor (C.S.G., R.G.O.); The Congenital Heart Institute of Florida, St. Petersburg (J.P.J.); Cincinnati Children's Medical Center, Cincinnati, OH (C.D.K.); Children's Hospital Los Angeles, Los Angeles, CA (A.B.L.); North Carolina Consortium: Duke University, Durham; East Carolina University, Greenville; Wake Forest University, Winston-Salem (S.K.P.); Nemours Cardiac Center, Wilmington, DE (C.P.); Primary Children's Medical Center and University of Utah, Salt Lake City (P.J.G.); Medical University of South Carolina, Charleston (A.M.A.); and Children's Hospital of Philadelphia and University of Pennsylvania Medical School, Philadelphia (J.W.G.).
Caren S GoldbergFrom the Boston Children's Hospital and Harvard Medical School, Boston, MA (J.W.N., C.D.-M.); New England Research Institutes, Watertown, MA (L.A.S., S.C.); Children's Hospital of Wisconsin and Medical College of Wisconsin, Milwaukee (P.C.F.); National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (G.D.P.); Emory University, Atlanta, GA (W.T.M.); Hospital for Sick Children, Toronto, ON, Canada (S.M., S.K.); Morgan Stanley Children's Hospital of New York-Presbyterian, New York (I.A.W.); University of Michigan Medical School, Ann Arbor (C.S.G., R.G.O.); The Congenital Heart Institute of Florida, St. Petersburg (J.P.J.); Cincinnati Children's Medical Center, Cincinnati, OH (C.D.K.); Children's Hospital Los Angeles, Los Angeles, CA (A.B.L.); North Carolina Consortium: Duke University, Durham; East Carolina University, Greenville; Wake Forest University, Winston-Salem (S.K.P.); Nemours Cardiac Center, Wilmington, DE (C.P.); Primary Children's Medical Center and University of Utah, Salt Lake City (P.J.G.); Medical University of South Carolina, Charleston (A.M.A.); and Children's Hospital of Philadelphia and University of Pennsylvania Medical School, Philadelphia (J.W.G.).
Jeffrey P JacobsFrom the Boston Children's Hospital and Harvard Medical School, Boston, MA (J.W.N., C.D.-M.); New England Research Institutes, Watertown, MA (L.A.S., S.C.); Children's Hospital of Wisconsin and Medical College of Wisconsin, Milwaukee (P.C.F.); National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (G.D.P.); Emory University, Atlanta, GA (W.T.M.); Hospital for Sick Children, Toronto, ON, Canada (S.M., S.K.); Morgan Stanley Children's Hospital of New York-Presbyterian, New York (I.A.W.); University of Michigan Medical School, Ann Arbor (C.S.G., R.G.O.); The Congenital Heart Institute of Florida, St. Petersburg (J.P.J.); Cincinnati Children's Medical Center, Cincinnati, OH (C.D.K.); Children's Hospital Los Angeles, Los Angeles, CA (A.B.L.); North Carolina Consortium: Duke University, Durham; East Carolina University, Greenville; Wake Forest University, Winston-Salem (S.K.P.); Nemours Cardiac Center, Wilmington, DE (C.P.); Primary Children's Medical Center and University of Utah, Salt Lake City (P.J.G.); Medical University of South Carolina, Charleston (A.M.A.); and Children's Hospital of Philadelphia and University of Pennsylvania Medical School, Philadelphia (J.W.G.).
Catherine D KrawczeskiFrom the Boston Children's Hospital and Harvard Medical School, Boston, MA (J.W.N., C.D.-M.); New England Research Institutes, Watertown, MA (L.A.S., S.C.); Children's Hospital of Wisconsin and Medical College of Wisconsin, Milwaukee (P.C.F.); National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (G.D.P.); Emory University, Atlanta, GA (W.T.M.); Hospital for Sick Children, Toronto, ON, Canada (S.M., S.K.); Morgan Stanley Children's Hospital of New York-Presbyterian, New York (I.A.W.); University of Michigan Medical School, Ann Arbor (C.S.G., R.G.O.); The Congenital Heart Institute of Florida, St. Petersburg (J.P.J.); Cincinnati Children's Medical Center, Cincinnati, OH (C.D.K.); Children's Hospital Los Angeles, Los Angeles, CA (A.B.L.); North Carolina Consortium: Duke University, Durham; East Carolina University, Greenville; Wake Forest University, Winston-Salem (S.K.P.); Nemours Cardiac Center, Wilmington, DE (C.P.); Primary Children's Medical Center and University of Utah, Salt Lake City (P.J.G.); Medical University of South Carolina, Charleston (A.M.A.); and Children's Hospital of Philadelphia and University of Pennsylvania Medical School, Philadelphia (J.W.G.).
Alan B LewisFrom the Boston Children's Hospital and Harvard Medical School, Boston, MA (J.W.N., C.D.-M.); New England Research Institutes, Watertown, MA (L.A.S., S.C.); Children's Hospital of Wisconsin and Medical College of Wisconsin, Milwaukee (P.C.F.); National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (G.D.P.); Emory University, Atlanta, GA (W.T.M.); Hospital for Sick Children, Toronto, ON, Canada (S.M., S.K.); Morgan Stanley Children's Hospital of New York-Presbyterian, New York (I.A.W.); University of Michigan Medical School, Ann Arbor (C.S.G., R.G.O.); The Congenital Heart Institute of Florida, St. Petersburg (J.P.J.); Cincinnati Children's Medical Center, Cincinnati, OH (C.D.K.); Children's Hospital Los Angeles, Los Angeles, CA (A.B.L.); North Carolina Consortium: Duke University, Durham; East Carolina University, Greenville; Wake Forest University, Winston-Salem (S.K.P.); Nemours Cardiac Center, Wilmington, DE (C.P.); Primary Children's Medical Center and University of Utah, Salt Lake City (P.J.G.); Medical University of South Carolina, Charleston (A.M.A.); and Children's Hospital of Philadelphia and University of Pennsylvania Medical School, Philadelphia (J.W.G.).
Sara K PasqualiFrom the Boston Children's Hospital and Harvard Medical School, Boston, MA (J.W.N., C.D.-M.); New England Research Institutes, Watertown, MA (L.A.S., S.C.); Children's Hospital of Wisconsin and Medical College of Wisconsin, Milwaukee (P.C.F.); National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (G.D.P.); Emory University, Atlanta, GA (W.T.M.); Hospital for Sick Children, Toronto, ON, Canada (S.M., S.K.); Morgan Stanley Children's Hospital of New York-Presbyterian, New York (I.A.W.); University of Michigan Medical School, Ann Arbor (C.S.G., R.G.O.); The Congenital Heart Institute of Florida, St. Petersburg (J.P.J.); Cincinnati Children's Medical Center, Cincinnati, OH (C.D.K.); Children's Hospital Los Angeles, Los Angeles, CA (A.B.L.); North Carolina Consortium: Duke University, Durham; East Carolina University, Greenville; Wake Forest University, Winston-Salem (S.K.P.); Nemours Cardiac Center, Wilmington, DE (C.P.); Primary Children's Medical Center and University of Utah, Salt Lake City (P.J.G.); Medical University of South Carolina, Charleston (A.M.A.); and Children's Hospital of Philadelphia and University of Pennsylvania Medical School, Philadelphia (J.W.G.).
Christian PizarroFrom the Boston Children's Hospital and Harvard Medical School, Boston, MA (J.W.N., C.D.-M.); New England Research Institutes, Watertown, MA (L.A.S., S.C.); Children's Hospital of Wisconsin and Medical College of Wisconsin, Milwaukee (P.C.F.); National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (G.D.P.); Emory University, Atlanta, GA (W.T.M.); Hospital for Sick Children, Toronto, ON, Canada (S.M., S.K.); Morgan Stanley Children's Hospital of New York-Presbyterian, New York (I.A.W.); University of Michigan Medical School, Ann Arbor (C.S.G., R.G.O.); The Congenital Heart Institute of Florida, St. Petersburg (J.P.J.); Cincinnati Children's Medical Center, Cincinnati, OH (C.D.K.); Children's Hospital Los Angeles, Los Angeles, CA (A.B.L.); North Carolina Consortium: Duke University, Durham; East Carolina University, Greenville; Wake Forest University, Winston-Salem (S.K.P.); Nemours Cardiac Center, Wilmington, DE (C.P.); Primary Children's Medical Center and University of Utah, Salt Lake City (P.J.G.); Medical University of South Carolina, Charleston (A.M.A.); and Children's Hospital of Philadelphia and University of Pennsylvania Medical School, Philadelphia (J.W.G.).
Peter J GruberFrom the Boston Children's Hospital and Harvard Medical School, Boston, MA (J.W.N., C.D.-M.); New England Research Institutes, Watertown, MA (L.A.S., S.C.); Children's Hospital of Wisconsin and Medical College of Wisconsin, Milwaukee (P.C.F.); National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (G.D.P.); Emory University, Atlanta, GA (W.T.M.); Hospital for Sick Children, Toronto, ON, Canada (S.M., S.K.); Morgan Stanley Children's Hospital of New York-Presbyterian, New York (I.A.W.); University of Michigan Medical School, Ann Arbor (C.S.G., R.G.O.); The Congenital Heart Institute of Florida, St. Petersburg (J.P.J.); Cincinnati Children's Medical Center, Cincinnati, OH (C.D.K.); Children's Hospital Los Angeles, Los Angeles, CA (A.B.L.); North Carolina Consortium: Duke University, Durham; East Carolina University, Greenville; Wake Forest University, Winston-Salem (S.K.P.); Nemours Cardiac Center, Wilmington, DE (C.P.); Primary Children's Medical Center and University of Utah, Salt Lake City (P.J.G.); Medical University of South Carolina, Charleston (A.M.A.); and Children's Hospital of Philadelphia and University of Pennsylvania Medical School, Philadelphia (J.W.G.).
Andrew M AtzFrom the Boston Children's Hospital and Harvard Medical School, Boston, MA (J.W.N., C.D.-M.); New England Research Institutes, Watertown, MA (L.A.S., S.C.); Children's Hospital of Wisconsin and Medical College of Wisconsin, Milwaukee (P.C.F.); National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (G.D.P.); Emory University, Atlanta, GA (W.T.M.); Hospital for Sick Children, Toronto, ON, Canada (S.M., S.K.); Morgan Stanley Children's Hospital of New York-Presbyterian, New York (I.A.W.); University of Michigan Medical School, Ann Arbor (C.S.G., R.G.O.); The Congenital Heart Institute of Florida, St. Petersburg (J.P.J.); Cincinnati Children's Medical Center, Cincinnati, OH (C.D.K.); Children's Hospital Los Angeles, Los Angeles, CA (A.B.L.); North Carolina Consortium: Duke University, Durham; East Carolina University, Greenville; Wake Forest University, Winston-Salem (S.K.P.); Nemours Cardiac Center, Wilmington, DE (C.P.); Primary Children's Medical Center and University of Utah, Salt Lake City (P.J.G.); Medical University of South Carolina, Charleston (A.M.A.); and Children's Hospital of Philadelphia and University of Pennsylvania Medical School, Philadelphia (J.W.G.).
Svetlana KhaikinFrom the Boston Children's Hospital and Harvard Medical School, Boston, MA (J.W.N., C.D.-M.); New England Research Institutes, Watertown, MA (L.A.S., S.C.); Children's Hospital of Wisconsin and Medical College of Wisconsin, Milwaukee (P.C.F.); National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (G.D.P.); Emory University, Atlanta, GA (W.T.M.); Hospital for Sick Children, Toronto, ON, Canada (S.M., S.K.); Morgan Stanley Children's Hospital of New York-Presbyterian, New York (I.A.W.); University of Michigan Medical School, Ann Arbor (C.S.G., R.G.O.); The Congenital Heart Institute of Florida, St. Petersburg (J.P.J.); Cincinnati Children's Medical Center, Cincinnati, OH (C.D.K.); Children's Hospital Los Angeles, Los Angeles, CA (A.B.L.); North Carolina Consortium: Duke University, Durham; East Carolina University, Greenville; Wake Forest University, Winston-Salem (S.K.P.); Nemours Cardiac Center, Wilmington, DE (C.P.); Primary Children's Medical Center and University of Utah, Salt Lake City (P.J.G.); Medical University of South Carolina, Charleston (A.M.A.); and Children's Hospital of Philadelphia and University of Pennsylvania Medical School, Philadelphia (J.W.G.).
J William GaynorFrom the Boston Children's Hospital and Harvard Medical School, Boston, MA (J.W.N., C.D.-M.); New England Research Institutes, Watertown, MA (L.A.S., S.C.); Children's Hospital of Wisconsin and Medical College of Wisconsin, Milwaukee (P.C.F.); National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (G.D.P.); Emory University, Atlanta, GA (W.T.M.); Hospital for Sick Children, Toronto, ON, Canada (S.M., S.K.); Morgan Stanley Children's Hospital of New York-Presbyterian, New York (I.A.W.); University of Michigan Medical School, Ann Arbor (C.S.G., R.G.O.); The Congenital Heart Institute of Florida, St. Petersburg (J.P.J.); Cincinnati Children's Medical Center, Cincinnati, OH (C.D.K.); Children's Hospital Los Angeles, Los Angeles, CA (A.B.L.); North Carolina Consortium: Duke University, Durham; East Carolina University, Greenville; Wake Forest University, Winston-Salem (S.K.P.); Nemours Cardiac Center, Wilmington, DE (C.P.); Primary Children's Medical Center and University of Utah, Salt Lake City (P.J.G.); Medical University of South Carolina, Charleston (A.M.A.); and Children's Hospital of Philadelphia and University of Pennsylvania Medical School, Philadelphia (J.W.G.).
Richard G OhyeFrom the Boston Children's Hospital and Harvard Medical School, Boston, MA (J.W.N., C.D.-M.); New England Research Institutes, Watertown, MA (L.A.S., S.C.); Children's Hospital of Wisconsin and Medical College of Wisconsin, Milwaukee (P.C.F.); National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (G.D.P.); Emory University, Atlanta, GA (W.T.M.); Hospital for Sick Children, Toronto, ON, Canada (S.M., S.K.); Morgan Stanley Children's Hospital of New York-Presbyterian, New York (I.A.W.); University of Michigan Medical School, Ann Arbor (C.S.G., R.G.O.); The Congenital Heart Institute of Florida, St. Petersburg (J.P.J.); Cincinnati Children's Medical Center, Cincinnati, OH (C.D.K.); Children's Hospital Los Angeles, Los Angeles, CA (A.B.L.); North Carolina Consortium: Duke University, Durham; East Carolina University, Greenville; Wake Forest University, Winston-Salem (S.K.P.); Nemours Cardiac Center, Wilmington, DE (C.P.); Primary Children's Medical Center and University of Utah, Salt Lake City (P.J.G.); Medical University of South Carolina, Charleston (A.M.A.); and Children's Hospital of Philadelphia and University of Pennsylvania Medical School, Philadelphia (J.W.G.).
Pediatric Heart Network Investigators
DuPont (United States) · US

Funding

Pediatric Heart network DCCU10HL068270 · NHLBI · NEW ENGLAND RESEARCH INSTITUTES, INC. · PI MILLER, JULIE ELAINE, TRACHTENBERG, FELICIA LYNN · 2011 to 2016
$44.9M
Ventricular Volumes and Varability (VVV)U01HL068270 · NHLBI · NEW ENGLAND RESEARCH INSTITUTES, INC. · PI SLEEPER, LYNN A · 2001 to 2010
$40.3M
SYNAPTIC MECHANISMS IN HIPPOCAMPAL EPILEPTOGENESISP30HD018655 · NICHD · CHILDREN'S HOSPITAL BOSTON · PI CHEN, CHINFEI · 1985 to 2015
$26.2M
Pediatric Heart Network: Follow-up of the Single Ventricle Reconstruction TrialU01HL068290 · NHLBI · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI LAI, WYMAN W · 2001 to 2010
$4.1M
Pediatric Heart Disease Network: CHOP MembershipU01HL068279 · NHLBI · CHILDREN'S HOSP OF PHILADELPHIA · PI VETTER, VICTORIA L · 2001 to 2010
$3.7M
Randomized Therapeutic Trials in Pediatric Heart DiseaseU01HL068285 · NHLBI · CHILDREN'S HOSPITAL BOSTON · PI NEWBURGER, JANE W. · 2001 to 2010
$3.4M
Randomized Clinical Trials for Pediatric Heart DiseaseU01HL068281 · NHLBI · MEDICAL UNIVERSITY OF SOUTH CAROLINA · PI SAUL, J PHILIP · 2001 to 2010
$3.2M
Clinical and genomic responses to remote ischemic preconditioningU01HL068288 · NHLBI · HOSPITAL FOR SICK CHLDRN (TORONTO) · PI MCCRINDLE, BRIAN W · 2001 to 2010
$3.0M
Intermountain Pediatric Heart Disease Research CenterU01HL068292 · NHLBI · UNIVERSITY OF UTAH · PI MINICH, L. LUANN · 2001 to 2010
$2.7M
Randomized Trial of Nonflouroscopic Technologies in Pediatric SVT AblationU10HL109816 · NHLBI · BOSTON CHILDREN'S HOSPITAL · PI NEWBURGER, JANE W., TRIEDMAN, JOHN K · 2011 to 2015
$2.6M
The Duke-UNC-CH Pediatric Cardiology Clinical CenterU01HL068269 · NHLBI · DUKE UNIVERSITY · PI LI, JENNIFER S · 2001 to 2010
$2.6M
Pediatric Heart Network Regents of the University of MichiganU10HL109737 · NHLBI · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI GOLDBERG, CAREN S, OHYE, RICHARD G · 2011 to 2015
$2.3M
NHLBI NIH HHS HL068269NHLBI NIH HHS HL068270NHLBI NIH HHS HL068279NHLBI NIH HHS HL068281NHLBI NIH HHS HL068285NHLBI NIH HHS HL068288NHLBI NIH HHS HL068290NHLBI NIH HHS HL068292NHLBI NIH HHS HL085057NHLBI NIH HHS U01 HL068269NHLBI NIH HHS U01 HL068270NHLBI NIH HHS U01 HL068279NHLBI NIH HHS U01 HL068281NHLBI NIH HHS U01 HL068285NHLBI NIH HHS U01 HL068288NHLBI NIH HHS U01 HL068290NHLBI NIH HHS U01 HL068292NHLBI NIH HHS U01 HL085057NHLBI NIH HHS U10 HL068270NHLBI NIH HHS U10 HL109737NHLBI NIH HHS U10 HL109778NHLBI NIH HHS U10 HL109816NICHD NIH HHS P30 HD018655
6 · The paper itself

Abstract

backgroundIn the Single Ventricle Reconstruction (SVR) trial, 1-year transplantation-free survival was better for the Norwood procedure with right ventricle-to-pulmonary artery shunt (RVPAS) compared with a modified Blalock-Taussig shunt (MBTS). At 3 years, we compared transplantation-free survival, echocardiographic right ventricular ejection fraction, and unplanned interventions in the treatment groups. METHODS AND

resultsVital status and medical history were ascertained from annual medical records, death indexes, and phone interviews. The cohort included 549 patients randomized and treated in the SVR trial. Transplantation-free survival for the RVPAS versus MBTS groups did not differ at 3 years (67% versus 61%; P=0.15) or with all available follow-up of 4.8±1.1 years (log-rank P=0.14). Pre-Fontan right ventricular ejection fraction was lower in the RVPAS group than in the MBTS group (41.7±5.1% versus 44.7±6.0%; P=0.007), and right ventricular ejection fraction deteriorated in RVPAS (P=0.004) but not MBTS (P=0.40) subjects (pre-Fontan minus 14-month mean, -3.25±8.24% versus 0.99±8.80%; P=0.009). The RVPAS versus MBTS treatment effect had nonproportional hazards (P=0.004); the hazard ratio favored the RVPAS before 5 months (hazard ratio=0.63; 95% confidence interval, 0.45-0.88) but the MBTS beyond 1 year (hazard ratio=2.22; 95% confidence interval, 1.07-4.62). By 3 years, RVPAS subjects had a higher incidence of catheter interventions (P<0.001) with an increasing HR over time (P=0.005): <5 months, 1.14 (95% confidence interval, 0.81-1.60); from 5 months to 1 year, 1.94 (95% confidence interval, 1.02-3.69); and >1 year, 2.48 (95% confidence interval, 1.28-4.80).

conclusionsBy 3 years, the Norwood procedure with RVPAS compared with MBTS was no longer associated with superior transplantation-free survival. Moreover, RVPAS subjects had slightly worse right ventricular ejection fraction and underwent more catheter interventions with increasing hazard ratio over time. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT00115934.

Indexed as

Aorta, ThoracicBlalock-Taussig ProcedureCardiac CatheterizationChild, PreschoolDisease-Free SurvivalFemaleFollow-Up StudiesHeart TransplantationHeart VentriclesHumansHypoplastic Left Heart SyndromeIncidenceInfantLogistic ModelsMaleNorwood Procedurescardiac surgical proceduresheart defects, congenitalheart diseasesheart ventriclesNorwood procedures

Identifiers

PMID24705119
PMCPMC4029928
OpenAlexW2065823779

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.