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, C; Charpie, John R.; Brown, Morton B.; Kulik, T. J.; Ohye, Richard G.

doi:10.1016/j.jtcvs.2006.11.029

Cited by 211 publications

(142 citation statements)

References 20 publications

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“…DHCA was compared directly with ACP in a randomized manner in 2 studies. In the first study, by Goldberg et al, 11 neonates undergoing the Norwood procedure were assigned to either DHCA or ACP. Neurodevelopment was tested at the age of 1 year, following the second stage of the Norwood procedure.…”

Section: Discussionmentioning

confidence: 99%

Neurological Injury After Neonatal Cardiac Surgery

et al. 2014

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S urvival after neonatal cardiac surgery has improved over the past decades to >90% because of major advances in surgical techniques and perioperative management. However, it has also become evident that neurodevelopment is impaired in approximately one third of children who underwent surgery at a neonatal age.1 As seen on magnetic resonance imaging (MRI), 23% to 40% of neonates presenting with a complex cardiac defect already have evidence of cerebral injury preoperatively.2-6 After surgery, 36% to 73% of patients have evidence of new cerebral lesions on MRI. [2][3][4][5][6][7][8] This suggests that much of the injury develops perioperatively. Clinical Perspective on p 233Neonates diagnosed with aortic arch obstruction (ie, hypoplastic left heart syndrome or other complex cardiac defects) are consistently at the highest risk of cerebral injury. 5,7,9 This may be attributable to the fact that full-flow cardiopulmonary bypass (CPB) is not feasible during the reconstruction of the aortic arch, obligating the use of either deep hypothermic circulatory arrest (DHCA) or antegrade cerebral perfusion (ACP). Despite initial reports on the adverse cerebral effects after DHCA and the intuitive benefit of ACP, previous studies have not been able to show superiority of ACP in studies of neurodevelopmental outcome at 1 year of age. 10,11 However, these results may be confounded by the reoperations that frequently take place in the interim.Therefore, in the present randomized, controlled trial, we used preoperative and postoperative MRI as the most sensitive measure to assess perioperative cerebral injury. Specifically, in neonates undergoing aortic arch reconstruction, the incidence of new postoperative injury on MRI was compared between DHCA and ACP.Background-Complex neonatal cardiac surgery is associated with cerebral injury. In particular, aortic arch repair, requiring either deep hypothermic circulatory arrest (DHCA) or antegrade cerebral perfusion (ACP), entails a high risk of perioperative injury. It is unknown whether ACP results in less cerebral injury than DHCA. Methods and Results-Thirty-seven neonates with an aortic arch obstruction presenting for univentricular or biventricular repair were randomized to either DHCA or ACP. Preoperatively and 1 week after surgery, magnetic resonance imaging was performed in 36 patients (1 patient died during the hospital stay). The presence of new postoperative cerebral injury was scored, and results were entered into a sequential analysis, which allows for immediate data analysis. After the 36th patient, it was clear that there was no difference between DHCA and ACP in terms of new cerebral injury. Preoperatively, 50% of patients had evidence of cerebral injury.

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Section: Discussionmentioning

confidence: 99%

Neurological Injury After Neonatal Cardiac Surgery

et al. 2014

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“…Neurodevelopmental outcomes are characterized by a diverse spectrum of developmental delays and disabilities including impaired executive functions with the prevalence and severity increasing with the complexity of the CHD [3][4][5][6][7]. The etiology of these neurodevelopmental disorders is complex and several variables including pre-existing brain abnormalities and evolving factors in the perioperative period are believed to play a significant role [8][9][10][11]. Thus, although the focus of neurodevelopmental studies was initially placed on the operative time period, preoperative brain abnormalities and early postoperative hemodynamic instability are also likely to play a significant role in later neurodevelopmental impairment [12][13][14][15][16][17].…”

Section: Introductionmentioning

confidence: 99%

Perioperative cerebral hemodynamics and oxygen metabolism in neonates with single-ventricle physiology

Dehaes

Cheng

Buckley

et al. 2015

Biomed. Opt. Express

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Abstract:Congenital heart disease (CHD) patients are at risk for neurodevelopmental delay. The etiology of these delays is unclear, but abnormal prenatal cerebral maturation and postoperative hemodynamic instability likely play a role. A better understanding of these factors is needed to improve neurodevelopmental outcome. In this study, we used bedside frequency-domain near infrared spectroscopy (FDNIRS) and diffuse correlation spectroscopy (DCS) to assess cerebral hemodynamics and oxygen metabolism in neonates with single-ventricle (SV) CHD undergoing surgery and compared them to controls. Our goals were 1) to compare cerebral hemodynamics between unanesthetized SV and healthy neonates, and 2) to determine if FDNIRS-DCS could detect alterations in cerebral hemodynamics beyond cerebral hemoglobin oxygen saturation (SO 2 ). Eleven SV neonates were recruited and compared to 13 controls. Preoperatively, SV patients showed decreased cerebral blood flow (CBF i ), cerebral oxygen metabolism (CMRO 2i ) and SO 2 ; and increased oxygen extraction fraction (OEF) compared to controls. Compared to preoperative values, unstable postoperative SV patients had decreased CMRO 2i and CBF i , which returned to baseline when stable. However, SO 2 showed no difference between unstable and stable states. Preoperative SV neonates are flow-limited and show signs of impaired cerebral development compared to controls. FDNIRS-DCS shows potential to improve assessment of cerebral development and postoperative hemodynamics compared to SO 2 alone. References and links 1. J. I. E. Hoffman and S. Kaplan, "The incidence of congenital heart disease," J. Am. Coll. Cardiol. 39, 1890-1900 A. Rappaport, and D. Wypij, "Randomized trial of hematocrit 25% versus 35% during hypothermic cardiopulmonary bypass in infant heart surgery," J. Thorac. Cardiovasc. Surg. 135, 347-54, 354.e1-4 (2008).

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“…28,29 Regional cerebral perfusion has been investigated as an alternative to deep hypothermic circulatory arrest. Some authors report no statistically significant differences in neurodevelopmental outcomes with this technique [32][33][34] ; however, a high incidence of stroke has been reported. 35 Other factors that have been associated with adverse neurodevelopmental outcomes include low gestational age, low birth weight, presence of a genetic syndrome, and high pre-and post-operative lactate.…”

Section: Opportunities For Intervention: Etiology Of Neurodevelopmentmentioning

confidence: 99%

Preventing Brain Injury in Newborns With Congenital Heart Disease

Sherlock

McQuillen

Miller

2009

Stroke

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Miller, MDCM, MAS; on behalf of aCCENTBackground and Purpose-Newborns with congenital heart disease are at high risk for brain injury and adverse neurodevelopmental outcomes. MRI enables the objective determination of the severity of brain injury in critically ill newborns with congenital heart disease. We will rationalize the use of MRI as a surrogate for neurodevelopmental outcome and describe novel randomization techniques that can be used in trials in this population. Methods-This article describes the evidence for the use of MRI and the link with neurodevelopmental outcome established in newborns. We also discuss the use of adaptive randomization techniques for future clinical trials in newborns with congenital heart disease. These strategies will be highlighted using an example. Results-Brain injuries occur with high frequency in newborns with congenital heart disease. It is not until school age that the full extent of neurological sequelae becomes apparent and the rapid pace of innovation in neonatal cardiac surgery prevents timely evaluation of changes in care. MRI provides a timely, safe, and reliable outcome measure and has been extensively studied in newborns with other conditions in which the link between brain injury and neurodevelopmental outcome has been established. Clinical trials using MRI as an outcome measure as well as adaptive randomization can improve the efficiency of such trials. Conclusions-Clinical trials of brain protection are urgently needed in newborns with congenital heart disease given the unacceptable frequency of brain injury in this population; MRI provides an early surrogate marker of long-term neurodevelopmental outcome and adaptive randomization can be used to improve the efficiency of these clinical trials. Key Words: brain injury Ⅲ congenital heart disease Ⅲ MRI Ⅲ neurodevelopment Ⅲ randomized, controlled trials E xperts have called for large clinical trials in the prevention of pediatric strokes based on the example set by pediatric oncology groups; oncology clinical trials have vastly improved the survival and outcomes of pediatric oncology survivors. 1 The incidence of stroke in the newborn is 20 per 100 000 live births and leads to a high risk of significant long-term neurological impairments for survivors, 2 including cerebral palsy, 3 cognitive deficits, visual disturbances, and epilepsy. 4 MRI is increasingly being used to detect stroke in the newborn. A number of imaging features of stroke are now recognized as predictors of adverse neurodevelopmental outcome. 3,5 Newborns with congenital heart disease (CHD) are at increased risk for brain injury and adverse neurodevelopmental outcomes. High-resolution MRI and diffusion tensor imaging enable us to objectively determine the severity of brain injury in these newborns. Periventricular leukomalacia and neonatal strokes have both been reported to be the most significant lesions in terms of severity and incidence in infants that undergo CHD repair 6,7 ; modifiable risk factors have been identified for both giving the ho...

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

Abstract: 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.

Cited by 211 publications

References 20 publications

Neurological Injury After Neonatal Cardiac Surgery

Neurological Injury After Neonatal Cardiac Surgery

Perioperative cerebral hemodynamics and oxygen metabolism in neonates with single-ventricle physiology

Preventing Brain Injury in Newborns With Congenital Heart Disease

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