The high heritability of HLHS suggests that it is determined largely by genetic factors. The frequent occurrence of left- and right-sided valve dysplasia in HLHS probands and the increased prevalence of BAV in family members suggests that HLHS is a severe form of valve malformation.

ethical analysis while bringing this crucial conversation to a new audience. We are at a watershed moment in health care. Ethical considerations have rarely been so integral and essential to maximising success of a technology both empirically and clinically. The time is right to partake in thoughtful and collaborative engagement on the challenge of bias to bring about lasting change.We declare no competing interests.

Accumulating evidence demonstrates the impact of bias that reflects social inequality on the performance of machine learning (ML) models in health care. Given their intended placement within healthcare decision making more broadly, ML tools require attention to adequately quantify the impact of bias and reduce its potential to exacerbate inequalities. We suggest that taking a patient safety and quality improvement approach to bias can support the quantification of bias-related effects on ML. Drawing from the ethical principles underpinning these approaches, we argue that patient safety and quality improvement lenses support the quantification of relevant performance metrics, in order to minimize harm while promoting accountability, justice, and transparency. We identify specific methods for operationalizing these principles with the goal of attending to bias to support better decision making in light of controllable and uncontrollable factors.

Objective Neonates with critical congenital heart disease remain at risk of adverse outcomes after cardiac surgery. Residual or undiagnosed anatomic lesions might be contributory. The present study aimed to describe the incidence and type of cardiac lesions that lead to early, unplanned cardiac reintervention, identify the risk factors for unplanned reintervention, and explore the associations between unplanned reinterventions and hospital mortality. Methods The present single-center retrospective cohort study included 943 consecutive neonates with critical congenital heart disease who underwent cardiac surgery from 2002 to 2008. An unplanned cardiac reintervention was defined as a cardiac reoperation or interventional cardiac catheterization performed during the same hospitalization as the initial operation. Multivariate logistic regression analyses were used to identify the risk factors for unplanned cardiac reintervention and hospital mortality. Results Of the 943 neonates, 104 (11%) underwent an unplanned cardiac reintervention. The independent predictors of unplanned reintervention included prenatal diagnosis, lower birth weight, need for mechanical ventilation before the initial cardiac operation, lower attending surgeon experience, and greater Risk Adjustment in Congenital Heart Surgery, version 1, category. Those who underwent reintervention had increased hospital mortality (n = 33/104, 32%) relative to those who did not (n = 31/839, 4%; adjusted odds ratio, 8.6; 95% confidence interval, 4.7 to 15.6; P < .001). The mortality rates among patients undergoing surgical reintervention (23/66, 35%) or transcatheter reintervention (4/16, 25%), or both (6/22, 27%) were similar (P = .66). Conclusions The need for unplanned cardiac reintervention in neonates with critical congenital heart disease is strongly associated with increased mortality. Early unplanned reinterventions might be an important covariate in outcomes studies and useful as a quality improvement measure.