Browsing by Author "Gaynor, J. William"

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    Development and Validation of a Seizure Prediction Model in Neonates Following Cardiac Surgery
    (Elsevier, 2020) Naim, Maryam Y.; Putt, Mary; Abend, Nicholas S.; Mastropietro, Christopher W.; Frank, Deborah U.; Chen, Jonathan M.; Fuller, Stephanie; Gangemi, James J.; Gaynor, J. William; Heinan, Kristin; Licht, Daniel J.; Mascio, Christopher E.; Massey, Shavonne; Roeser, Mark E.; Smith, Clyde J.; Kimmel, Stephen E.; Pediatrics, School of Medicine
    BACKGROUND Electroencephalographic seizures (ES) following neonatal cardiac surgery are often subclinical and have been associated with poor outcomes. An accurate ES prediction model could allow targeted continuous electroencephalographic monitoring (CEEG) for high-risk neonates. METHODS Development and validation of ES prediction models in a multi-center prospective cohort where all postoperative neonates with cardiopulmonary bypass (CPB) underwent CEEG. RESULTS ES occurred in 7.4% of neonates (78 of 1053). Model predictors included gestational age, head circumference, single ventricle defect, DHCA duration, cardiac arrest, nitric oxide, ECMO, and delayed sternal closure. The model performed well in the derivation cohort (c-statistic 0.77, Hosmer-Lemeshow p=0.56), with a net benefit (NB) over monitoring all and none over a threshold probability of 2% in decision curve analysis (DCA). The model had good calibration in the validation cohort (Hosmer-Lemeshow, p=0.60); however, discrimination was poor (c-statistic 0.61) and in DCA there was no NB of the prediction model between the threshold probabilities of 8% and 18%. Using a cut-point that emphasized negative predictive value (NPV) in the derivation cohort, 32% (236 of 737) of neonates would not undergo CEEG, including 3.5% (2 of 58) with ES (NPV 99%, sensitivity 97%). CONCLUSIONS In this large prospective cohort, a prediction model of ES in neonates following CPB had good performance in the derivation cohort with a NB in DCA. However, performance in the validation cohort was weak with poor discrimination, calibration, and no NB in DCA. These findings support CEEG monitoring of all neonates following CPB.
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    Impact of Major Residual Lesions on Outcomes after Surgery for Congenital Heart Disease
    (Elsevier, 2021) Nathan, Meena; Levine, Jami C.; Van Rompay, Maria I.; Lambert, Linda M.; Trachtenberg, Felicia L.; Colan, Steven D.; Adachi, Iki; Anderson, Brett R.; Bacha, Emile A.; Eckhauser, Aaron; Gaynor, J. William; Graham, Eric M.; Goot, Benjamin; Jacobs, Jeffrey P.; John, Rija; Kaltman, Jonathan R.; Kanter, Kirk R.; Mery, Carlos M.; Minich, L. LuAnn; Ohye, Richard; Overman, David; Pizarro, Christian; Raghuveer, Geetha; Schamberger, Marcus S.; Schwartz, Steven M.; Narasimhan, Shanthi L.; Taylor, Michael D.; Wang, Ke; Newburger, Jane W.; Pediatric Heart Network Investigators; Pediatrics, School of Medicine
    Background: Many factors affect outcomes after congenital cardiac surgery. Objectives: The RLS (Residual Lesion Score) study explored the impact of severity of residual lesions on post-operative outcomes across operations of varying complexity. Methods: In a prospective, multicenter, observational study, 17 sites enrolled 1,149 infants undergoing 5 common operations: tetralogy of Fallot repair (n = 250), complete atrioventricular septal defect repair (n = 249), arterial switch operation (n = 251), coarctation or interrupted arch with ventricular septal defect (VSD) repair (n = 150), and Norwood operation (n = 249). The RLS was assigned based on post-operative echocardiography and clinical events: RLS 1 (trivial or no residual lesions), RLS 2 (minor residual lesions), or RLS 3 (reintervention for or major residual lesions before discharge). The primary outcome was days alive and out of hospital within 30 post-operative days (60 for Norwood). Secondary outcomes assessed post-operative course, including major medical events and days in hospital. Results: RLS 3 (vs. RLS 1) was an independent risk factor for fewer days alive and out of hospital (p ≤ 0.008) and longer post-operative hospital stay (p ≤ 0.02) for all 5 operations, and for all secondary outcomes after coarctation or interrupted arch with VSD repair and Norwood (p ≤ 0.03). Outcomes for RLS 1 versus 2 did not differ consistently. RLS alone explained 5% (tetralogy of Fallot repair) to 20% (Norwood) of variation in the primary outcome. Conclusions: Adjusting for pre-operative factors, residual lesions after congenital cardiac surgery impacted in-hospital outcomes across operative complexity with greatest impact following complex operations. Minor residual lesions had minimal impact. These findings may provide guidance for surgeons when considering short-term risks and benefits of returning to bypass to repair residual lesions.