Document Detail


Interstage mortality after the Norwood procedure: Results of the multicenter Single Ventricle Reconstruction trial.
MedLine Citation:
PMID:  22795436     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
OBJECTIVE: For 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.
METHODS: Participants 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.
RESULTS: Overall 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).
CONCLUSIONS: Interstage 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.
Authors:
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; 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;
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Publication Detail:
Type:  Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, N.I.H., Extramural     Date:  2012-07-11
Journal Detail:
Title:  The Journal of thoracic and cardiovascular surgery     Volume:  144     ISSN:  1097-685X     ISO Abbreviation:  J. Thorac. Cardiovasc. Surg.     Publication Date:  2012 Oct 
Date Detail:
Created Date:  2012-09-17     Completed Date:  2012-11-30     Revised Date:  2014-04-15    
Medline Journal Info:
Nlm Unique ID:  0376343     Medline TA:  J Thorac Cardiovasc Surg     Country:  United States    
Other Details:
Languages:  eng     Pagination:  896-906     Citation Subset:  AIM; IM    
Copyright Information:
Copyright © 2012 The American Association for Thoracic Surgery. Published by Mosby, Inc. All rights reserved.
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00115934
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MeSH Terms
Descriptor/Qualifier:
Blalock-Taussig Procedure / adverse effects,  mortality*
Heart Defects, Congenital / mortality,  physiopathology,  surgery*
Heart Ventricles / abnormalities,  physiopathology,  surgery*
Hemodynamics
Humans
Hypoplastic Left Heart Syndrome / mortality,  physiopathology,  surgery*
Infant Mortality
Infant, Newborn
Kaplan-Meier Estimate
Logistic Models
Multivariate Analysis
North America
Norwood Procedures / adverse effects,  mortality*
Odds Ratio
Postoperative Complications / etiology,  mortality
Prospective Studies
Risk Assessment
Risk Factors
Time Factors
Treatment Outcome
Ventricular Function
Grant Support
ID/Acronym/Agency:
HL068269/HL/NHLBI NIH HHS; HL068270/HL/NHLBI NIH HHS; HL068279/HL/NHLBI NIH HHS; HL068285/HL/NHLBI NIH HHS; HL068288/HL/NHLBI NIH HHS; HL068290/HL/NHLBI NIH HHS; HL068292/HL/NHLBI NIH HHS; HL085057/HL/NHLBI NIH HHS; U01 HL068270/HL/NHLBI NIH HHS
Investigator
Investigator/Affiliation:
Gail Pearson / ; Victoria Pemberton / ; Rae-Ellen Kavey / ; Mario Stylianou / ; Marsha Mathis / ; Lynn Mahony / ; Lynn Sleeper / ; Sharon Tennstedt / ; Steven Colan / ; Lisa Virzi / ; Patty Connell / ; Victoria Muratov / ; Lisa Wruck / ; Minmin Lu / ; Dianne Gallagher / ; Anne Devine / ; Julie Schonbeck / ; Thomas Travison / ; David F Teitel / ; Jane W Newburger / ; Peter Laussen / ; Pedro del Nido / ; Roger Breitbart / ; Jami Levine / ; Ellen McGrath / ; Carolyn Dunbar-Masterson / ; John E Mayer / ; Frank Pigula / ; Emile A Bacha / ; Francis Fynn-Thompson / ; Wyman Lai / ; Beth Printz / ; Daphne Hsu / ; William Hellenbrand / ; Ismee Williams / ; Ashwin Prakash / ; Seema Mital / ; Ralph Mosca / ; Darlene Servedio / ; Rozelle Corda / ; Rosalind Korsin / ; Mary Nash / ; Victoria L Vetter / ; Sarah Tabbutt / ; J William Gaynor / ; Chitra Ravishankar / ; Thomas Spray / ; Meryl Cohen / ; Marisa Nolan / ; Stephanie Piacentino / ; Sandra DiLullo / ; Nicole Mirarchi / ; D Woodrow Benson / ; Catherine Dent Krawczeski / ; Lois Bogenschutz / ; Teresa Barnard / ; Michelle Hamstra / ; Rachel Griffiths / ; Kathryn Hogan / ; Steven Schwartz / ; David Nelson / ; Pirooz Eghtesady / ; Page A W Anderson / ; Jennifer Li / ; Wesley Covitz / ; Kari Crawford / ; Michael Hines / ; James Jaggers / ; Theodore Koutlas / ; Charlie Sang / ; Lori Jo Sutton / ; Mingfen Xu / ; J Philip Saul / ; Andrew Atz / ; Girish Shirali / ; Scott Bradley / ; Eric Graham / ; Teresa Atz / ; Patricia Infinger / ; L LuAnn Minich / ; John A Hawkins / ; Michael Puchalski / ; Richard V Williams / ; Peter C Kouretas / ; Linda M Lambert / ; Marian E Shearrow / ; Jun A Porter / ; Brian McCrindle / ; Joel Kirsh / ; Chris Caldarone / ; Elizabeth Radojewski / ; Svetlana Khaikin / ; Susan McIntyre / ; Nancy Slater / ; Caren S Goldberg / ; Richard G Ohye / ; Cheryl Nowak / ; Nancy S Ghanayem / ; James S Tweddell / ; Kathleen A Mussatto / ; Michele A Frommelt / ; Peter C Frommelt / ; Lisa Young-Borkowski / ; Alan Lewis / ; Vaughn Starnes / ; Nancy Pike / ; Jeffrey P Jacobs / ; James A Quintessenza / ; Paul J Chai / ; David S Cooper / ; J Blaine John / ; James C Huhta / ; Tina Merola / ; Tracey Grifith / ; William Mahle / ; Kirk Kanter / ; Joel Bond / ; Jeryl Huckaby / ; Christian Pizarro / ; Carol Prospero / ; Julie Simons / ; Gina Baffa / ; Wolfgang A Radtke / ; Ilana Zeltzer / ; Tia Tortoriello / ; Deborah McElroy / ; Deborah Town / ; John Rhodes / ; J Curt Fudge / ; Peter Frommelt / ; Gerald Marx / ; Catherine Stolle / ; Michael Artman / ; Erle Austin / ; Timothy Feltes / ; Julie Johnson / ; Thomas Klitzner / ; Jeffrey Krischer / ; G Paul Matherne / ; John Kugler / ; Rae-Ellen Kavey / ; David J Driscoll / ; Mark Galantowicz / ; Sally A Hunsberger / ; Thomas J Knight / ; Holly Taylor / ; Catherine L Webb /
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