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

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

doi:10.1016/j.jtcvs.2006.11.029

« Previous Next »The Journal of Thoracic and Cardiovascular Surgery
Volume 133, Issue 4 , Pages 880-887.e1, April 2007

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

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

Caren S. Goldberg, MD
- Division of Pediatric Cardiology, University of Michigan, Ann Arbor, Mich
- 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.
Edward L. Bove, MD
- Section of Cardiac Surgery, University of Michigan, Ann Arbor, Mich
Eric J. Devaney, MD
- Section of Cardiac Surgery, University of Michigan, Ann Arbor, Mich
Eileen Mollen, PhD
- Division of Pediatric Psychology, University of Michigan, Ann Arbor, Mich
Edward Schwartz, PhD
- Division of Pediatric Psychology, University of Michigan, Ann Arbor, Mich
Shauna Tindall, PhD
- Division of Pediatric Psychology, University of Michigan, Ann Arbor, Mich
Cheryl Nowak, RN
- Section of Cardiac Surgery, University of Michigan, Ann Arbor, Mich
John Charpie, MD
- Division of Pediatric Cardiology, University of Michigan, Ann Arbor, Mich
Morton B. Brown, PhD
- School of Public Health, Department of Biostatistics, University of Michigan, Ann Arbor, Mich.
Tom J. Kulik, MD
- Division of Pediatric Cardiology, University of Michigan, Ann Arbor, Mich
Richard G. Ohye, MD
- Section of Cardiac Surgery, University of Michigan, Ann Arbor, Mich

Received 20 June 2006; received in revised form 8 November 2006; accepted 20 November 2006. published online 06 March 2007.

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.

CTSNet classification: 19, 21

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