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J Thorac Cardiovasc Surg 2008;136:968-975
© 2008 The American Association for Thoracic Surgery

Surgery for Congenital Heart Disease

Design and rationale of a randomized trial comparing the Blalock–Taussig and right ventricle–pulmonary artery shunts in the Norwood procedure

^a University of Michigan Medical School, Ann Arbor, Mich
^b The Children's Hospital of Philadelphia, Philadelphia, Pa
^c Herma Heart Center at the Children's Hospital of Wisconsin, Milwaukee, Wisconsin
^d Children's Hospital Boston and Harvard Medical School, Boston, Mass
^e National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Md
^f New England Research Institutes, Watertown, Mass
^g Medical University of South Carolina, Charleston, SC
^h Duke University Medical Center, Durham, NC
ⁱ The Hospital for Sick Children, Toronto, Ontario, Canada
^j Columbia University Medical Center, New York, NY
^k Primary Children's Medical Center, Salt Lake City, Utah
^l University of Texas Southwestern Medical Center, Dallas, Tex

Received for publication October 17, 2007; accepted for publication January 16, 2008.

^_* Address for reprints: Richard G. Ohye, MD, 5144 CVC/SPC 5864, 1500 East Medical Center Drive, Ann Arbor, Michigan 48109-5864. (Email: ohye{at}umich.edu).

Objective: The initial palliative procedure for patients born with hypoplastic left heart syndrome and related single right ventricle anomalies, the Norwood procedure, remains among the highest risk procedures in congenital heart surgery. The classic Norwood procedure provides pulmonary blood flow with a modified Blalock–Taussig shunt. Improved outcomes have been reported in a few small, nonrandomized studies of a modification of the Norwood procedure that uses a right ventricle–pulmonary artery shunt to provide pulmonary blood flow. Other nonrandomized studies have shown no differences between the two techniques.

Methods: The Pediatric Heart Network designed a randomized clinical trial to compare outcomes for subjects undergoing a Norwood procedure with either the right ventricle–pulmonary artery or modified Blalock–Taussig shunt. Infants with a diagnosis of single, morphologically right ventricle anomaly who are undergoing a Norwood procedure are eligible for inclusion in this study. The primary outcome is death or cardiac transplant 12 months after random assignment. Secondary outcomes include postoperative morbidity after Norwood and stage II palliation procedures, right ventricular function and pulmonary arterial growth at stage II palliation, and neurodevelopmental outcomes at 14 months old. Incidence of adverse events will also be compared between treatment groups.

Conclusion: This study will make an important contribution to the care of patients with hypoplastic left heart syndrome and related forms of single, morphologically right ventricle. It also establishes a model with which other operative interventions for patients with congenital cardiovascular malformations can be evaluated in the future.

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