Risk factors for hospital morbidity and mortality after the Norwood procedure: A report from the Pediatric Heart Network Single Ventricle Reconstruction trial

J Thorac Cardiovasc Surg. 2012 Oct;144(4):882-95. doi: 10.1016/j.jtcvs.2012.05.019. Epub 2012 Jun 15.

Abstract

Objectives: We sought to identify risk factors for mortality and morbidity during the Norwood hospitalization in newborn infants with hypoplastic left heart syndrome and other single right ventricle anomalies enrolled in the Single Ventricle Reconstruction trial.

Methods: Potential predictors for outcome included patient- and procedure-related variables and center volume and surgeon volume. Outcome variables occurring during the Norwood procedure and before hospital discharge or stage II procedure included mortality, end-organ complications, length of ventilation, and hospital length of stay. Univariate and multivariable Cox regression analyses were performed with bootstrapping to estimate reliability for mortality.

Results: Analysis included 549 subjects prospectively enrolled from 15 centers; 30-day and hospital mortality were 11.5% (63/549) and 16.0% (88/549), respectively. Independent risk factors for both 30-day and hospital mortality included lower birth weight, genetic abnormality, extracorporeal membrane oxygenation (ECMO) and open sternum on the day of the Norwood procedure. In addition, longer duration of deep hypothermic circulatory arrest was a risk factor for 30-day mortality. Shunt type at the end of the Norwood procedure was not a significant risk factor for 30-day or hospital mortality. Independent risk factors for postoperative renal failure (n = 46), sepsis (n = 93), increased length of ventilation, and hospital length of stay among survivors included genetic abnormality, lower center/surgeon volume, open sternum, and post-Norwood operations.

Conclusions: Innate patient factors, ECMO, open sternum, and lower center/surgeon volume are important risk factors for postoperative mortality and/or morbidity during the Norwood hospitalization.

Trial registration: ClinicalTrials.gov NCT00115934.

Publication types

  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural

MeSH terms

  • Blalock-Taussig Procedure / adverse effects*
  • Blalock-Taussig Procedure / mortality
  • Disease-Free Survival
  • Heart Defects, Congenital / mortality
  • Heart Defects, Congenital / physiopathology
  • Heart Defects, Congenital / surgery*
  • Heart Ventricles / abnormalities
  • Heart Ventricles / physiopathology
  • Heart Ventricles / surgery*
  • Hemodynamics
  • Hospital Mortality
  • Humans
  • Hypoplastic Left Heart Syndrome / mortality
  • Hypoplastic Left Heart Syndrome / physiopathology
  • Hypoplastic Left Heart Syndrome / surgery*
  • Infant Mortality
  • Infant, Newborn
  • Kaplan-Meier Estimate
  • Length of Stay
  • Multivariate Analysis
  • North America
  • Norwood Procedures / adverse effects*
  • Norwood Procedures / mortality
  • Postoperative Complications / etiology
  • Postoperative Complications / mortality
  • Postoperative Complications / therapy
  • Proportional Hazards Models
  • Prospective Studies
  • Risk Assessment
  • Risk Factors
  • Time Factors
  • Treatment Outcome
  • Ventricular Function

Associated data

  • ClinicalTrials.gov/NCT00115934