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Comparison of shunt types in the Norwood procedure for single-ventricle lesions. N Engl J Med 2010 May 27;362(21):1980-92

Date

05/28/2010

Pubmed ID

20505177

Pubmed Central ID

PMC2891109

DOI

10.1056/NEJMoa0912461

Scopus ID

2-s2.0-77952760954   485 Citations

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.)

Author List

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, Pediatric Heart Network Investigators

Author

Peter C. Frommelt MD Professor in the Pediatrics department at Medical College of Wisconsin




MESH terms used to index this publication - Major topics in bold

Cardiac Surgical Procedures
Female
Follow-Up Studies
Heart Bypass, Right
Heart Transplantation
Heart Ventricles
Humans
Hypoplastic Left Heart Syndrome
Infant, Newborn
Intention to Treat Analysis
Kaplan-Meier Estimate
Male
Postoperative Complications
Proportional Hazards Models
Pulmonary Artery
jenkins-FCD Prod-398 336d56a365602aa89dcc112f077233607d6a5abc