Comparison of shunt types in the Norwood procedure for single-ventricle lesions

Richard G. Ohye, Lynn A. Sleeper, Lynn Mahony, Jane W. Newburger, Gail D. Pearson, Minmin Lu, Caren S. Goldberg, Sarah Tabbutt, Peter C. Frommelt, Nancy S. Ghanayem, Peter C. Laussen, John F. Rhodes, Alan B. Lewis, Seema Mital, Chitra Ravishankar, Ismee A. Williams, Carolyn Dunbar-Masterson, Andrew M. Atz, Steven Colan, L. LuAnn Minich & 9 others Christian Pizarro, Kirk R. Kanter, James Jaggers, Jeffrey P. Jacobs, Catherine Dent Krawczeski, Nancy Pike, Brian W. McCrindle, Lisa Virzi, J. William Gaynor

Research output: Contribution to journalArticle

483 Citations (Scopus)

Abstract

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.)

Original languageEnglish (US)
Pages (from-to)1980-1992
Number of pages13
JournalNew England Journal of Medicine
Volume362
Issue number21
DOIs
StatePublished - May 27 2010

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Norwood Procedures
Blalock-Taussig Procedure
Pulmonary Artery
Heart Ventricles
Transplantation
Right Ventricular Function
Random Allocation
Heart Transplantation
Mortality

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Ohye, R. G., Sleeper, L. A., Mahony, L., Newburger, J. W., Pearson, G. D., Lu, M., ... Gaynor, J. W. (2010). Comparison of shunt types in the Norwood procedure for single-ventricle lesions. New England Journal of Medicine, 362(21), 1980-1992. https://doi.org/10.1056/NEJMoa0912461

Comparison of shunt types in the Norwood procedure for single-ventricle lesions. / 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.

In: New England Journal of Medicine, Vol. 362, No. 21, 27.05.2010, p. 1980-1992.

Research output: Contribution to journalArticle

Ohye, RG, Sleeper, LA, Mahony, L, Newburger, JW, Pearson, GD, Lu, M, Goldberg, CS, Tabbutt, S, Frommelt, PC, Ghanayem, NS, Laussen, PC, Rhodes, JF, Lewis, AB, Mital, S, Ravishankar, C, Williams, IA, Dunbar-Masterson, C, Atz, AM, Colan, S, Minich, LL, Pizarro, C, Kanter, KR, Jaggers, J, Jacobs, JP, Krawczeski, CD, Pike, N, McCrindle, BW, Virzi, L & Gaynor, JW 2010, 'Comparison of shunt types in the Norwood procedure for single-ventricle lesions', New England Journal of Medicine, vol. 362, no. 21, pp. 1980-1992. https://doi.org/10.1056/NEJMoa0912461
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. / Comparison of shunt types in the Norwood procedure for single-ventricle lesions. In: New England Journal of Medicine. 2010 ; Vol. 362, No. 21. pp. 1980-1992.
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abstract = "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.)",
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T1 - Comparison of shunt types in the Norwood procedure for single-ventricle lesions

AU - Ohye, Richard G.

AU - Sleeper, Lynn A.

AU - Mahony, Lynn

AU - Newburger, Jane W.

AU - Pearson, Gail D.

AU - Lu, Minmin

AU - Goldberg, Caren S.

AU - Tabbutt, Sarah

AU - Frommelt, Peter C.

AU - Ghanayem, Nancy S.

AU - Laussen, Peter C.

AU - Rhodes, John F.

AU - Lewis, Alan B.

AU - Mital, Seema

AU - Ravishankar, Chitra

AU - Williams, Ismee A.

AU - Dunbar-Masterson, Carolyn

AU - Atz, Andrew M.

AU - Colan, Steven

AU - Minich, L. LuAnn

AU - Pizarro, Christian

AU - Kanter, Kirk R.

AU - Jaggers, James

AU - Jacobs, Jeffrey P.

AU - Krawczeski, Catherine Dent

AU - Pike, Nancy

AU - McCrindle, Brian W.

AU - Virzi, Lisa

AU - Gaynor, J. William

PY - 2010/5/27

Y1 - 2010/5/27

N2 - 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.)

AB - 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.)

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