Evidence map›Paper›PMID 25440099›Full record

Trial reportJournal of the American College of Cardiology2014

Impact of initial shunt type on cardiac size and function in children with single right ventricle anomalies before the Fontan procedure: the single ventricle reconstruction extension trial.

Peter C Frommelt, Eric Gerstenberger, James F Cnota, Meryl S Cohen, Jessica Gorentz, Kevin D Hill, J Blaine John, Jami C Levine, Jimmy Lu, William T Mahle and 9 more

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of the American College of Cardiology, 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 19 papers.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed
–field-weighted citation impact
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

19 citing papers in PubMed.

  1. Trial
  2. Trial
  3. The Impact of the Left Ventricle on Right Ventricular Function and Clinical Outcomes in Infants with Single-Right Ventricle Anomalies up to 14 Months of Age.Journal of the American Society of Echocardiography : official publication of the American Society of Echocardiography · 2018
    Trial
  4. Trial
  5. Article
  6. Review
  7. Article
  8. Article
  9. Article
  10. Article
  11. Article
  12. Hypoplastic left heart syndrome [HLHS]: treatment options in present era.Indian journal of thoracic and cardiovascular surgery · 2019
    Review
  13. Heart failure after the Norwood procedure: An analysis of the Single Ventricle Reconstruction Trial.The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation · 2018
    Article
  14. Article
  15. Observational
  16. Article
  17. Review
  18. Article
  19. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

19 authors.

Peter C FrommeltMedical College of Wisconsin, Milwaukee, Wisconsin. Electronic address: pfrommelt@chw.org.
Eric GerstenbergerNew England Research Institute, Watertown, Massachusetts.
James F CnotaCincinnati Children's Hospital, Cincinnati, Ohio.
Meryl S CohenThe Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.
Jessica GorentzMedical College of Wisconsin, Milwaukee, Wisconsin.
Kevin D HillDuke University, Durham, North Carolina.
J Blaine JohnCongenital Heart Institute of Florida/Pediatrix, Tampa, Florida.
Jami C LevineBoston Children's Hospital, Boston, Massachusetts.
Jimmy LuUniversity of Michigan, Ann Arbor, Michigan.
William T MahleEmory University School of Medicine, Atlanta, Georgia.
Rachel T McCandlessPrimary Children's Hospital, Salt Lake City, Utah.
Luc MertensHospital for Sick Children, Toronto, Ontario, Canada.
Gail D PearsonNational Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland.
Carolyn SpencerMedical University of South Carolina, Charleston, South Carolina.
Deepika ThackerAlfred I. DuPont Hospital for Children, Wilmington, Delaware.
Ismee A WilliamsColumbia University Medical Center, New York, New York.
Pierre C WongChildren's Hospital of Los Angeles, Los Angeles, California.
Jane W NewburgerBoston Children's Hospital, Boston, Massachusetts.
Pediatric Heart Network Investigators

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
RESEARCH TRAINING IN PEDIATRIC NEPHROLOGYT32DK007726 · NIDDK · CHILDREN'S HOSPITAL BOSTON · PI BRISCOE, DAVID M. · 1994 to 2023
$5.9M
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 Prairieland ConsortiumU10HL109673 · NHLBI · CINCINNATI CHILDRENS HOSP MED CTR · PI CNOTA, JAMES, PAYNE, RONALD MARK · 2011 to 2015
$2.3M
NHLBI 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 U01 HL109737NHLBI NIH HHS U01 HL109781NHLBI NIH HHS U10 HL068270NHLBI NIH HHS U10 HL109673NHLBI NIH HHS U10 HL109737NHLBI NIH HHS U10 HL109743NHLBI NIH HHS U10 HL109781NHLBI NIH HHS U10 HL109816NIDDK NIH HHS T32 DK007726
6 · The paper itself

Abstract

backgroundIn children with single right ventricular (RV) anomalies, changes in RV size and function may be influenced by shunt type chosen at the time of the Norwood procedure.

objectivesThe study sought to identify shunt-related differences in echocardiographic findings at 14 months and ≤6 months pre-Fontan in survivors of the Norwood procedure.

methodsWe compared 2-dimensional and Doppler echocardiographic indices of RV size and function, neo-aortic and tricuspid valve annulus dimensions and function, and aortic size and patency at 14.1 ± 1.2 months and 33.6 ± 9.6 months in subjects randomized to a Norwood procedure using either the modified Blalock-Taussig shunt (MBTS) or right ventricle to pulmonary artery shunt (RVPAS).

resultsAcceptable echocardiograms were available at both time points in 240 subjects (114 MBTS, 126 RVPAS). At 14 months, all indices were similar between shunt groups. From the 14-month to pre-Fontan echocardiogram, the MBTS group had stable indexed RV volumes and ejection fraction, while the RVPAS group had increased RV end-systolic volume (p = 0.004) and decreased right ventricular ejection fraction (RVEF) (p = 0.004). From 14 months to pre-Fontan, the treatment groups were similar with respect to decline in indexed neo-aortic valve area, >mild neo-aortic valve regurgitation (<5% at each time), indexed tricuspid valve area, and ≥moderate tricuspid valve regurgitation (<20% at each time).

conclusionsInitial Norwood shunt type influences pre-Fontan RV remodeling during the second and third years of life in survivors with single RV anomalies, with greater RVEF deterioration after RVPAS. Encouragingly, other indices of RV function remain stable before Fontan regardless of shunt type. (Comparison of Two Types of Shunts in Infants with Single Ventricle Defect Undergoing Staged Reconstruction-Pediatric Heart Network; NCT00115934).

Indexed as

AortaChildChild, PreschoolEchocardiographyEchocardiography, DopplerFemaleFollow-Up StudiesFontan ProcedureHeartHumansInfantLongitudinal StudiesMaleNorwood ProceduresOrgan SizeSystoleechocardiographyhypoplastic left heart syndromeNorwood

Identifiers

PMID25440099
PMCPMC4254493

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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.