Comparison of shunt types in the Norwood procedure for single-ventricle lesions
Open accessAbstract
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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Stage 1 Norwood palliation for single-ventricle heart disease is among the highest-risk operations in congenital cardiac surgery.
“Stage 1 Norwood palliation is one of the highest risk procedures in congenital cardiac surgery.”
From Utility of a standardized postcardiopulmonary bypass epicardial echocardiography protocol for stage I Norwood palliation: STERN et al. (2017) · cites this paper as [14]
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- Authors
- Ohye, R. G., Sleeper, L. A., Mahony, L., Newburger, J. W., Pearson, G. D., Lu, M., Goldberg, C. S., Tabbutt, S., Frommelt, P. C., Ghanayem, N. S., Laussen, P. C., Rhodes, J. F., Lewis, A. B., Mital, S., Ravishankar, C., Williams, I. A., Dunbar-Masterson, C., Atz, A. M., Colan, S., Minich, L. L., Pizarro, C., Kanter, K. R., Jaggers, J., Jacobs, J. P., Krawczeski, C. D., Pike, N., McCrindle, B. W., Virzi, L., & Gaynor, J. W.
- Affiliations
- Duke University (US)
- Boston Children's Hospital (US)
- Children's Hospital of Philadelphia (US)
- Children's Hospital of Wisconsin (US)
- Wake Forest University (US)
- Children's Hospital Los Angeles (US)
- Hospital for Sick Children (CA)
- Medical University of South Carolina (US)
- Primary Children's Hospital (US)
- Emory University (US)
- Cincinnati Children's Hospital Medical Center (US)
- ORCID
- Ohye, Richard G.
- Sleeper, Lynn A.
- Mahony, Lynn
- Newburger, Jane W.
- Goldberg, Caren S.
- Tabbutt, Sarah
- Frommelt, Peter C.
- Rhodes, John F.
- Lewis, Alan B.
- Mital, Seema
- Ravishankar, Chitra
- Atz, Andrew M.
- Colan, Steven
- Minich, L. LuAnn
- Pizarro, Christian
- Jaggers, James
- Jacobs, Jeffrey P.
- Krawczeski, Catherine Dent
- Pike, Nancy
- McCrindle, Brian W.
- Gaynor, J. William
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2010-05-27
- Volume
- 362
- Issue
- 21
- Pages
- 1980-1992
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- PMC
- PMC2891109
- OpenAlex
- W2075318595
- Cited by
- 920
- References
- 26
- Citations by year
- 2026: 29 · 2025: 38 · 2024: 35 · 2023: 62 · 2022: 62 · 2021: 58 · 2020: 59 · 2019: 47 · 2018: 55 · 2017: 75 · 2016: 65 · 2015: 65 · 2014: 65 · 2013: 60 · 2012: 66
- FWCI
- 47.38
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Europe PMC (PubMed Central) (acceptedVersion)
- PubMed Central (acceptedVersion)
- Funders
- National Institutes of Health (2u01hl068281-06)
- National Heart, Lung, and Blood Institute (HL085057, U01HL068288, HL068281, U01-HL-068281, U10HL109816, U01HL068292, U10HL068270, U01HL068290, HL068270, U01HL068285, HL068290, U01HL085057, HL068269, HL068285, U01HL068270, U10HL109778, HL068288, U01HL068279, U01HL068269, HL068279, HL068292)
- Topics
- Health Sciences › Medicine › Epidemiology › Congenital Heart Disease Studies
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Congenital heart defects research
- Health Sciences › Medicine › Radiology, Nuclear Medicine and Imaging › Cardiovascular Conditions and Treatments
- Keywords
- Norwood procedure, modified Blalock-Taussig shunt, single ventricle congenital heart disease, palliative surgery, transplant-free survival, ventriculotomy, right ventricular function, infants
- MeSH terms
- Female, Follow-Up Studies, Cardiac Surgical Procedures, Heart Ventricles, Humans, Infant, Newborn, Male, Postoperative Complications, Pulmonary Artery, Proportional Hazards Models, Heart Transplantation, Heart Bypass, Right, Hypoplastic Left Heart Syndrome, Kaplan-Meier Estimate, Intention to Treat Analysis
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