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

Sarah Tabbutt, Nancy Ghanayem, Chitra Ravishankar, Lynn A Sleeper, David S Cooper, Deborah U Frank, Minmin Lu, Christian Pizarro, Peter Frommelt, Caren S Goldberg, Eric M Graham, Catherine Dent Krawczeski, Wyman W Lai, Alan Lewis, Joel A Kirsh, Lynn Mahony, Richard G Ohye, Janet Simsic, Andrew J Lodge, Ellen Spurrier, Mario Stylianou, Peter Laussen, Pediatric Heart Network Investigators, 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 Jr, 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 Jr, 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, Gerald Marx, Catherine Stolle, Michael Artman, Erle Austin, Timothy Feltes, Julie Johnson, Thomas Klitzner, Jeffrey Krischer, Paul Matherne, John Kugler, Rae-Ellen Kavey, David J Driscoll, Mark Galantowicz, Sally A Hunsberger, Thomas J Knight, Holly Taylor, Catherine L Webb, Sarah Tabbutt, Nancy Ghanayem, Chitra Ravishankar, Lynn A Sleeper, David S Cooper, Deborah U Frank, Minmin Lu, Christian Pizarro, Peter Frommelt, Caren S Goldberg, Eric M Graham, Catherine Dent Krawczeski, Wyman W Lai, Alan Lewis, Joel A Kirsh, Lynn Mahony, Richard G Ohye, Janet Simsic, Andrew J Lodge, Ellen Spurrier, Mario Stylianou, Peter Laussen, Pediatric Heart Network Investigators, 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 Jr, 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 Jr, 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, Gerald Marx, Catherine Stolle, Michael Artman, Erle Austin, Timothy Feltes, Julie Johnson, Thomas Klitzner, Jeffrey Krischer, Paul Matherne, John Kugler, Rae-Ellen Kavey, David J Driscoll, Mark Galantowicz, Sally A Hunsberger, Thomas J Knight, Holly Taylor, Catherine L Webb

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.

Copyright © 2012 The American Association for Thoracic Surgery. Published by Mosby, Inc. All rights reserved.

Figures

FIGURE 1
FIGURE 1
Kaplan-Meier estimates and pointwise 95% confidence bands for hospital survival after the Norwood procedure (N = 549). Patients were censored when they were transplanted (n = 9) or discharged (n = 430).
FIGURE 2
FIGURE 2
Kaplan-Meier estimates for transplant-free survival after the Norwood procedure using all available follow-up (mean, 2.7 ± 0.9 years for survivors). Group classification is according to extracorporeal membrane oxygenation (ECMO), cardiopulmonary resuscitation (CPR), ECMO required to restore circulation during CPR (E-CPR), and none of these interventions (none) within the first 30 days after the Norwood procedure.

Source: PubMed

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