Comparison of Shunt Types in the Norwood Procedure for Single-Ventricle Lesions

Hypoplastic left heart syndrome is a complex congenital heart lesion that requires a three-stage procedure for surgical palliation. This clinical trial examines two approaches to the first stage of the procedure, and the results provide important guidance for the most appropriate surgical management...

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Veröffentlicht in:	The New England journal of medicine Jg. 362; H. 21; S. 1980 - 1992
Hauptverfasser:	Ohye, Richard G, Sleeper, Lynn A, Mahony, Lynn, Newburger, Jane W, Pearson, Gail D, Lu, Minmin, Goldberg, Caren S, Tabbutt, Sarah, Frommelt, Peter C, Ghanayem, Nancy S, Laussen, Peter C, Rhodes, John F, Lewis, Alan B, Mital, Seema, Ravishankar, Chitra, Williams, Ismee A, Dunbar-Masterson, Carolyn, Atz, Andrew M, Colan, Steven, Minich, L. LuAnn, Pizarro, Christian, Kanter, Kirk R, Jaggers, James, Jacobs, Jeffrey P, Krawczeski, Catherine Dent, Pike, Nancy, McCrindle, Brian W, Virzi, Lisa, Gaynor, J. William
Format:	Journal Article
Sprache:	Englisch
Veröffentlicht:	Waltham, MA Massachusetts Medical Society 27.05.2010
Schlagworte:	Biological and medical sciences Cardiac Surgical Procedures - methods Cardiology. Vascular system Congenital heart diseases. Malformations of the aorta, pulmonary vessels and vena cava Female Follow-Up Studies General aspects Heart Heart Bypass, Right - methods Heart Transplantation - statistics & numerical data Heart Ventricles - abnormalities Heart Ventricles - surgery Humans Hypoplastic Left Heart Syndrome - mortality Hypoplastic Left Heart Syndrome - surgery Infant, Newborn Intention to Treat Analysis Kaplan-Meier Estimate Male Medical sciences Postoperative Complications Proportional Hazards Models Pulmonary arteries Pulmonary Artery - surgery Veins & arteries Medicine Methodology Shunt Heart disease Cardiovascular disease Procedure Single ventricle Lesion Congenital disease Comparative study
ISSN:	0028-4793, 1533-4406, 1533-4406
Online-Zugang:	Volltext
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Abstract	Hypoplastic left heart syndrome is a complex congenital heart lesion that requires a three-stage procedure for surgical palliation. This clinical trial examines two approaches to the first stage of the procedure, and the results provide important guidance for the most appropriate surgical management of this serious lesion. This clinical trial examines two approaches to the first stage of the Norwood procedure, and the results provide important guidance for the most appropriate surgical management of this serious lesion. Hypoplastic left heart syndrome and related anomalies involving a single right ventricle are characterized by hypoplasia of the left heart and the aorta, with compromised systemic cardiac output (Figure 1). Infants with the syndrome generally undergo a three-stage reconstruction culminating in the Fontan procedure. The first operation (stage I) is the Norwood procedure, in which the right ventricle is connected to a reconstructed aorta with the use of the proximal main pulmonary artery for systemic outflow. Pulmonary blood flow is reestablished by means of a shunt from the pulmonary artery to the systemic circulation. In the second operation (stage II), . . .
AbstractList	Hypoplastic left heart syndrome is a complex congenital heart lesion that requires a three-stage procedure for surgical palliation. This clinical trial examines two approaches to the first stage of the procedure, and the results provide important guidance for the most appropriate surgical management of this serious lesion. This clinical trial examines two approaches to the first stage of the Norwood procedure, and the results provide important guidance for the most appropriate surgical management of this serious lesion. Hypoplastic left heart syndrome and related anomalies involving a single right ventricle are characterized by hypoplasia of the left heart and the aorta, with compromised systemic cardiac output (Figure 1). Infants with the syndrome generally undergo a three-stage reconstruction culminating in the Fontan procedure. The first operation (stage I) is the Norwood procedure, in which the right ventricle is connected to a reconstructed aorta with the use of the proximal main pulmonary artery for systemic outflow. Pulmonary blood flow is reestablished by means of a shunt from the pulmonary artery to the systemic circulation. In the second operation (stage II), . . . The Norwood procedure with a modified Blalock-Taussig (MBT) shunt, the first palliative stage for single-ventricle lesions with systemic outflow obstruction, is associated with high mortality. The right ventricle-pulmonary artery (RVPA) shunt may improve coronary flow but requires a ventriculotomy. We compared the two shunts in infants with hypoplastic heart syndrome or related anomalies.BACKGROUNDThe Norwood procedure with a modified Blalock-Taussig (MBT) shunt, the first palliative stage for single-ventricle lesions with systemic outflow obstruction, is associated with high mortality. The right ventricle-pulmonary artery (RVPA) shunt may improve coronary flow but requires a ventriculotomy. We compared the two shunts in infants with hypoplastic heart syndrome or related anomalies.Infants undergoing the Norwood procedure were randomly assigned to the MBT shunt (275 infants) or the RVPA shunt (274 infants) at 15 North American centers. The primary outcome was death or cardiac transplantation 12 months after randomization. Secondary outcomes included unintended cardiovascular interventions and right ventricular size and function at 14 months and transplantation-free survival until the last subject reached 14 months of age.METHODSInfants undergoing the Norwood procedure were randomly assigned to the MBT shunt (275 infants) or the RVPA shunt (274 infants) at 15 North American centers. The primary outcome was death or cardiac transplantation 12 months after randomization. Secondary outcomes included unintended cardiovascular interventions and right ventricular size and function at 14 months and transplantation-free survival until the last subject reached 14 months of age.Transplantation-free survival 12 months after randomization was higher with the RVPA shunt than with the MBT shunt (74% vs. 64%, P=0.01). However, the RVPA shunt group had more unintended interventions (P=0.003) and complications (P=0.002). Right ventricular size and function at the age of 14 months and the rate of nonfatal serious adverse events at the age of 12 months were similar in the two groups. Data collected over a mean (+/-SD) follow-up period of 32+/-11 months showed a nonsignificant difference in transplantation-free survival between the two groups (P=0.06). On nonproportional-hazards analysis, the size of the treatment effect differed before and after 12 months (P=0.02).RESULTSTransplantation-free survival 12 months after randomization was higher with the RVPA shunt than with the MBT shunt (74% vs. 64%, P=0.01). However, the RVPA shunt group had more unintended interventions (P=0.003) and complications (P=0.002). Right ventricular size and function at the age of 14 months and the rate of nonfatal serious adverse events at the age of 12 months were similar in the two groups. Data collected over a mean (+/-SD) follow-up period of 32+/-11 months showed a nonsignificant difference in transplantation-free survival between the two groups (P=0.06). On nonproportional-hazards analysis, the size of the treatment effect differed before and after 12 months (P=0.02).In children undergoing the Norwood procedure, transplantation-free survival at 12 months was better with the RVPA shunt than with the MBT shunt. After 12 months, available data showed no significant difference in transplantation-free survival between the two groups. (ClinicalTrials.gov number, NCT00115934.)CONCLUSIONSIn children undergoing the Norwood procedure, transplantation-free survival at 12 months was better with the RVPA shunt than with the MBT shunt. After 12 months, available data showed no significant difference in transplantation-free survival between the two groups. (ClinicalTrials.gov number, NCT00115934.) The Norwood procedure with a modified Blalock-Taussig (MBT) shunt, the first palliative stage for single-ventricle lesions with systemic outflow obstruction, is associated with high mortality. The right ventricle-pulmonary artery (RVPA) shunt may improve coronary flow but requires a ventriculotomy. We compared the two shunts in infants with hypoplastic heart syndrome or related anomalies. Infants undergoing the Norwood procedure were randomly assigned to the MBT shunt (275 infants) or the RVPA shunt (274 infants) at 15 North American centers. The primary outcome was death or cardiac transplantation 12 months after randomization. Secondary outcomes included unintended cardiovascular interventions and right ventricular size and function at 14 months and transplantation-free survival until the last subject reached 14 months of age. Transplantation-free survival 12 months after randomization was higher with the RVPA shunt than with the MBT shunt (74% vs. 64%, P=0.01). However, the RVPA shunt group had more unintended interventions (P=0.003) and complications (P=0.002). Right ventricular size and function at the age of 14 months and the rate of nonfatal serious adverse events at the age of 12 months were similar in the two groups. Data collected over a mean (+/-SD) follow-up period of 32+/-11 months showed a nonsignificant difference in transplantation-free survival between the two groups (P=0.06). On nonproportional-hazards analysis, the size of the treatment effect differed before and after 12 months (P=0.02). In children undergoing the Norwood procedure, transplantation-free survival at 12 months was better with the RVPA shunt than with the MBT shunt. After 12 months, available data showed no significant difference in transplantation-free survival between the two groups. (ClinicalTrials.gov number, NCT00115934.) Background The Norwood procedure with a modified Blalock-Taussig (MBT) shunt, the first palliative stage for single-ventricle lesions with systemic outflow obstruction, is associated with high mortality. The right ventricle-pulmonary artery (RVPA) shunt may improve coronary flow but requires a ventriculotomy. We compared the two shunts in infants with hypoplastic heart syndrome or related anomalies. Methods Infants undergoing the Norwood procedure were randomly assigned to the MBT shunt (275 infants) or the RVPA shunt (274 infants) at 15 North American centers. The primary outcome was death or cardiac transplantation 12 months after randomization. Secondary outcomes included unintended cardiovascular interventions and right ventricular size and function at 14 months and transplantation-free survival until the last subject reached 14 months of age. Results Transplantation-free survival 12 months after randomization was higher with the RVPA shunt than with the MBT shunt (74% vs. 64%, P=0.01). However, the RVPA shunt group had more unintended interventions (P=0.003) and complications (P=0.002). Right ventricular size and function at the age of 14 months and the rate of nonfatal serious adverse events at the age of 12 months were similar in the two groups. Data collected over a mean (±SD) follow-up period of 32±11 months showed a nonsignificant difference in transplantation-free survival between the two groups (P=0.06). On nonproportional-hazards analysis, the size of the treatment effect differed before and after 12 months (P=0.02). Conclusions In children undergoing the Norwood procedure, transplantation-free survival at 12 months was better with the RVPA shunt than with the MBT shunt. After 12 months, available data showed no significant difference in transplantation-free survival between the two groups. (ClinicalTrials.gov number, NCT00115934 .)
Author	Ohye, Richard G McCrindle, Brian W Pike, Nancy Jaggers, James Mital, Seema Mahony, Lynn Lu, Minmin Frommelt, Peter C Ravishankar, Chitra Williams, Ismee A Atz, Andrew M Lewis, Alan B Newburger, Jane W Ghanayem, Nancy S Sleeper, Lynn A Minich, L. LuAnn Colan, Steven Jacobs, Jeffrey P Gaynor, J. William Virzi, Lisa Tabbutt, Sarah Krawczeski, Catherine Dent Laussen, Peter C Rhodes, John F Dunbar-Masterson, Carolyn Kanter, Kirk R Pearson, Gail D Goldberg, Caren S Pizarro, Christian
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BackLink	http://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=22834211$$DView record in Pascal Francis https://www.ncbi.nlm.nih.gov/pubmed/20505177$$D View this record in MEDLINE/PubMed
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Cites_doi	10.1016/j.athoracsur.2004.06.020 10.1016/j.athoracsur.2004.05.055 10.1016/S0003-4975(00)01349-7 10.1016/0021-9681(74)90015-0 10.1067/mtc.2000.106838 10.1016/S0003-4975(01)02795-3 10.1542/peds.2006-1592 10.1016/j.athoracsur.2004.06.014 10.1016/S0003-4975(03)01386-9 10.1016/j.athoracsur.2003.10.002 10.1016/j.athoracsur.2006.11.076 10.1016/j.jtcvs.2006.09.034 10.1161/01.cir.0000087390.94142.1d 10.1016/S0022-5223(19)39288-8 10.1016/S0022-5223(03)00389-1 10.1161/01.RES.17.5.427 10.1016/j.athoracsur.2005.04.046 10.1016/j.jtcvs.2008.01.013 10.1016/S0002-9149(99)80161-1 10.1016/S0022-5223(19)38300-X 10.1016/S0003-4975(03)00343-6 10.1097/01.PCC.0000201003.38320.63 10.1007/s00246-005-1151-9 10.1016/S0003-4975(00)02324-9 10.1016/j.jtcvs.2007.12.012
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Keywords	Medicine Methodology Shunt Heart disease Cardiovascular disease Procedure Single ventricle Lesion Congenital disease Comparative study
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Snippet	Hypoplastic left heart syndrome is a complex congenital heart lesion that requires a three-stage procedure for surgical palliation. This clinical trial... The Norwood procedure with a modified Blalock-Taussig (MBT) shunt, the first palliative stage for single-ventricle lesions with systemic outflow obstruction,... Background The Norwood procedure with a modified Blalock-Taussig (MBT) shunt, the first palliative stage for single-ventricle lesions with systemic outflow...
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SubjectTerms	Biological and medical sciences Cardiac Surgical Procedures - methods Cardiology. Vascular system Congenital heart diseases. Malformations of the aorta, pulmonary vessels and vena cava Female Follow-Up Studies General aspects Heart Heart Bypass, Right - methods Heart Transplantation - statistics & numerical data Heart Ventricles - abnormalities Heart Ventricles - surgery Humans Hypoplastic Left Heart Syndrome - mortality Hypoplastic Left Heart Syndrome - surgery Infant, Newborn Intention to Treat Analysis Kaplan-Meier Estimate Male Medical sciences Postoperative Complications Proportional Hazards Models Pulmonary arteries Pulmonary Artery - surgery Veins & arteries
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Title	Comparison of Shunt Types in the Norwood Procedure for Single-Ventricle Lesions
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