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J Thorac Cardiovasc Surg 2007;133:880-887
© 2007 The American Association for Thoracic Surgery

Surgery for Congenital Heart Disease

A randomized clinical trial of regional cerebral perfusion versus deep hypothermic circulatory arrest: Outcomes for infants with functional single ventricle

Caren S. Goldberg, MDa,*, Edward L. Bove, MDb, Eric J. Devaney, MDb, Eileen Mollen, PhDc, Edward Schwartz, PhDc, Shauna Tindall, PhDc, Cheryl Nowak, RNb, John Charpie, MDa, Morton B. Brown, PhDd, Tom J. Kulik, MDa, Richard G. Ohye, MDb

a Division of Pediatric Cardiology, University of Michigan, Ann Arbor, Mich
b Section of Cardiac Surgery, University of Michigan, Ann Arbor, Mich
c Division of Pediatric Psychology, University of Michigan, Ann Arbor, Mich
d School of Public Health, Department of Biostatistics, University of Michigan, Ann Arbor, Mich.

Read at the Eighty-sixth Annual Meeting of The American Association for Thoracic Surgery, Philadelphia, Pa, April 29-May 3, 2006.

Received for publication June 20, 2006; revisions received November 8, 2006; accepted for publication November 20, 2006.

* Address for reprints: Caren S. Goldberg, MD, C.S. Mott Children’s Hospital, L1221 Women’s Box 0204, 1500 East Medical Center Dr, Ann Arbor, MI 48109-0204. (Email: cgoldber{at}umich.edu).

Objective: Regional cerebral perfusion has been adopted as a means to improve neuroprotection during aortic arch reconstruction. The purpose of this study was to determine whether a strategy of regional cerebral perfusion rather than one of deep hypothermic circulatory arrest during aortic arch reconstruction would improve neurodevelopment without increasing morbidity or mortality for patients undergoing the Norwood operation.

Methods: A randomized trial was performed in infants with single ventricle anatomy undergoing the Norwood operation. Participants were randomized to deep hypothermic circulatory arrest or regional cerebral perfusion. Neurodevelopment was measured before second-stage surgery and at 1 year by the Bayley Scales of Infant Development-II, Psychomotor Development Index and Mental Development Index. Intent-to-treat analysis was performed.

Results: Seventy-seven patients were enrolled. Survival to hospital discharge was 88% and to 1-year follow-up, 75%, without a significant difference between groups. For the entire cohort, the mean (SD) psychomotor development index score was 77 (20) and the mean mental development index score was 92 (21), with psychomotor development index lower than mental development index both before second-stage surgery (P < .0001) and at 1 year (P < .0001). There were no statistical differences in mental development or psychomotor development scores between the groups at pre–second-stage operation or 1-year follow-up, although the point estimates were consistently lower for the regional cerebral perfusion group.

Conclusion: Infant development is delayed after the Norwood operation. Pilot data do not suggest that regional cerebral perfusion improves infant development. Further study with a multicenter clinical trial is imperative to address this important question.

Abbreviations and Acronyms BSID-II = Bayley Scales of Infant Development II; DHCA = deep hypothermic circulatory arrest; HLHS = hypoplastic left heart syndrome; MDI = Mental Development Index; PDI = Psychomotor Development Index; RCP = regional cerebral perfusion


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