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

doi:10.1016/j.jtcvs.2008.01.013

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

Richard G. Ohye, MD^a^,_*, J. William Gaynor, MD^b, Nancy S. Ghanayem, MD^c, Caren S. Goldberg, MD, MS^a, Peter C. Laussen, MBBS^d, Peter C. Frommelt, MD^c, Jane W. Newburger, MD, MPH^d, Gail D. Pearson, MD, ScD^e, Sarah Tabbutt, MD, PhD^b, Gil Wernovsky, MD^b, Lisa M. Wruck, PhD^f, Andrew M. Atz, MD^g, Steve D. Colan, MD^d, James Jaggers, MD^h, Brian W. McCrindle, MD, MPHⁱ, Ashwin Prakash, MD^j, Michael D. Puchalski, MD^k, Lynn A. Sleeper, ScD^f, Mario P. Stylianou, PhD^e, Lynn Mahony, MD^l Pediatric Heart Network Investigators (see Appendix)

^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 hypoplasticleft heart syndrome and related single right ventricle anomalies,the Norwood procedure, remains among the highest risk proceduresin congenital heart surgery. The classic Norwood procedure providespulmonary blood flow with a modified Blalock–Taussig shunt.Improved outcomes have been reported in a few small, nonrandomizedstudies of a modification of the Norwood procedure that usesa right ventricle–pulmonary artery shunt to provide pulmonaryblood flow. Other nonrandomized studies have shown no differencesbetween the two techniques.

Methods: The Pediatric Heart Network designed a randomized clinical trialto compare outcomes for subjects undergoing a Norwood procedurewith either the right ventricle–pulmonary artery or modifiedBlalock–Taussig shunt. Infants with a diagnosis of single,morphologically right ventricle anomaly who are undergoing aNorwood procedure are eligible for inclusion in this study.The primary outcome is death or cardiac transplant 12 monthsafter random assignment. Secondary outcomes include postoperativemorbidity after Norwood and stage II palliation procedures,right ventricular function and pulmonary arterial growth atstage II palliation, and neurodevelopmental outcomes at 14 monthsold. Incidence of adverse events will also be compared betweentreatment groups.

Conclusion: This study will make an important contribution to the care ofpatients with hypoplastic left heart syndrome and related formsof single, morphologically right ventricle. It also establishesa model with which other operative interventions for patientswith congenital cardiovascular malformations can be evaluatedin the future.

Abbreviations and Acronyms APOE = apolipoprotein E genotype;CPB = cardiopulmonary bypass; HLHS = hypoplastic left heartsyndrome; MBTS = modified Blalock–Taussig shunt; PA =pulmonary artery; PHN = Pediatric Heart Network; RV = rightventricle

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