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| A Randomized Clinical Trial of Regional Cerebral Perfusion versus Deep Hypothermic Circulatory Arrest: Outcomes for Infants with Functional Single Ventricle | ||||||||||||||||||||
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Back to 86th Annual Meeting Back to Program Outline Objectives: With improved survival for children with hypoplastic left heart syndrome, neurodevelopmental abnormalities have become more evident. Deep hypothermic circulatory arrest (DHCA) is thought to contribute to neurologic compromise. Regional cerebral perfusion (RCP) has been adopted as a potential means to improve neuroprotection during aortic arch reconstruction. The purpose of this study was to determine if RCP rather than DHCA for aortic arch reconstruction will be associated with improved neurodevelopment without increasing morbidity or mortality in patients undergoing the Norwood operation. Methods: A single center, randomized, controlled, clinical trial was performed in infants with single ventricle anatomy undergoing a Norwood operation. Participants were stratified by risk group and surgeon, then randomized to DHCA or RCP as the primary technique during aortic arch reconstruction. Neurodevelopment was measured pre-second stage surgery and at one year, using the Bayley Scales of Infant Development-II, Psychomotor Development Index (PDI) and Mental Development Index (MDI) (Mean 100, SD 15). Socioeconomic status (SES) was measured using the Hollingshead Four Factor Index. Intent to treat analysis was performed. Results: Seventy-seven patients were enrolled to date. Forty-four patients were assigned to RCP and 37 to DHCA. There was no differences in gender (p=.31) or SES (p=.41). There was no significant difference in survival to hospital discharge (RCP 90% and DHCA 86%, p=.73), or survival to one year (RCP 68% and DHCA 81%, p=.17). Preliminary analysis of neurodevelpmental outcome was performed after 40 patients returned for one-year follow-up PDI and MDI. There were no statistical differences in MDI or PDI scores between the RCP and DHCA groups at pre-second stage operation or at one-year follow-up. However the point estimates were consistently lower for the RCP group then the DHCA group (Table I). For the entire cohort, PDI scores were consistently and significantly lower than MDI scores at pre-second stage (p<.0001) and one-year (p<.0001) evaluations.
Conclusion: Infant development is delayed in children following the Norwood operation with PDI scores consistently and significantly lower than MDI scores. Pilot data does not suggest that RCP improves infant development. Further study with a multicenter clinical trial is imperative to address this important question. Back to 86th Annual Meeting Back to Program Outline |
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