Evidence map›Paper›PMID 22795436›Full record

Trial reportThe Journal of thoracic and cardiovascular surgery2012

Interstage mortality after the Norwood procedure: Results of the multicenter Single Ventricle Reconstruction trial.

Nancy S Ghanayem, Kerstin R Allen, Sarah Tabbutt, Andrew M Atz, Martha L Clabby, David S Cooper, Pirooz Eghtesady, Peter C Frommelt, Peter J Gruber, Kevin D Hill and 11 more

Abstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in The Journal of thoracic and cardiovascular surgery, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 136 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
136citing papers in PubMed, 7 pooled it
–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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

136 citing papers in PubMed, 7 syntheses or guidelines pooled it.

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  15. Technical performance score is associated with outcomes after the Norwood procedure.The Journal of thoracic and cardiovascular surgery · 2014
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76 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

21 authors.

Nancy S GhanayemChildren's Hospital of Wisconsin and Medical College of Wisconsin, Milwaukee, WI, USA. nancyg@mcw.edu
Kerstin R Allen
Sarah Tabbutt
Andrew M Atz
Martha L Clabby
David S Cooper
Pirooz Eghtesady
Peter C Frommelt
Peter J Gruber
Kevin D Hill
Jonathan R Kaltman
Peter C Laussen
Alan B Lewis
Karen J Lurito
L LuAnn Minich
Richard G Ohye
Julie V Schonbeck
Steven M Schwartz
Rakesh K Singh
Caren S Goldberg
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
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
The Duke-UNC-CH Pediatric Cardiology Clinical CenterU01HL068269 · NHLBI · DUKE UNIVERSITY · PI LI, JENNIFER S · 2001 to 2010
$2.6M
Preoperative Therapy for Prevention of Postoperative Low Cardiac Output SyndromeU01HL085057 · NHLBI · CINCINNATI CHILDRENS HOSP MED CTR · PI BENSON, DUDLEY WOODROW (WOODY) · 2006 to 2010
$1.5M
NHLBI NIH HHS HL068269NHLBI NIH HHS HL068270NHLBI NIH HHS HL068279NHLBI 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 HL068270
6 · The paper itself

Abstract

objectiveFor infants with single ventricle malformations undergoing staged repair, interstage mortality is reported at 2% to 20%. The Single Ventricle Reconstruction trial randomized subjects with a single morphologic right ventricle undergoing a Norwood procedure to a modified Blalock-Taussig shunt (MBTS) or a right ventricle-to-pulmonary artery shunt (RVPAS). The aim of this analysis was to explore the associations of interstage mortality and shunt type, and demographic, anatomic, and perioperative factors.

methodsParticipants in the Single Ventricle Reconstruction trial who survived to discharge after the Norwood procedure were included (n = 426). Interstage mortality was defined as death postdischarge after the Norwood procedure and before the stage II procedure. Univariate analysis and multivariable logistic regression were performed adjusting for site.

resultsOverall interstage mortality was 50 of 426 (12%)-13 of 225 (6%) for RVPAS and 37 of 201 (18%) for MBTS (odds ratio [OR] for MBTS, 3.4; P < .001). When moderate to severe postoperative atrioventricular valve regurgitation (AVVR) was present, interstage mortality was similar between shunt types. Interstage mortality was independently associated with gestational age less than 37 weeks (OR, 3.9; P = .008), Hispanic ethnicity (OR, 2.6; P = .04), aortic atresia/mitral atresia (OR, 2.3; P = .03), greater number of post-Norwood complications (OR, 1.2; P = .006), census block poverty level (P = .003), and MBTS in subjects with no or mild postoperative AVVR (OR, 9.7; P < .001).

conclusionsInterstage mortality remains high at 12% and is increased with the MBTS compared with the RVPAS if postoperative AVVR is absent or mild. Preterm delivery, anatomic, and socioeconomic factors are also important. Avoiding preterm delivery when possible and close surveillance after Norwood hospitalization for infants with identified risk factors may reduce interstage mortality.

Indexed as

Blalock-Taussig ProcedureHeart Defects, CongenitalHeart VentriclesHemodynamicsHumansHypoplastic Left Heart SyndromeInfant MortalityInfant, NewbornKaplan-Meier EstimateLogistic ModelsMultivariate AnalysisNorth AmericaNorwood ProceduresOdds RatioPostoperative ComplicationsProspective Studies

Identifiers

PMID22795436
PMCPMC3985484

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Registered trials

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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.