Guidelines and Recommendations for Targeted Neonatal Echocardiography and Cardiac Point-of-Care Ultrasound in the Neonatal Intensive Care Unit: An Update from the American Society of Echocardiography.

Targeted neonatal echocardiography (TNE) involves the use of comprehensive echocardiography to appraise cardiovascular physiology and neonatal hemodynamics to enhance diagnostic and therapeutic precision in the neonatal intensive care unit. Since the last publication of guidelines for TNE in 2011, the field has matured through the development of formalized neonatal hemodynamics fellowships, clinical programs, and the expansion of scientific knowledge to further enhance clinical care. The most common indications for TNE include adjudication of hemodynamic significance of a patent ductus arteriosus, evaluation of acute and chronic pulmonary hypertension, evaluation of right and left ventricular systolic and/or diastolic function, and screening for pericardial effusions and/or malpositioned central catheters. Neonatal cardiac point-of-care ultrasound (cPOCUS) is a limited cardiovascular evaluation which may include line tip evaluation, identification of pericardial effusion and differentiation of hypovolemia from severe impairment in myocardial contractility in the hemodynamically unstable neonate. This document is the product of an American Society of Echocardiography task force composed of representatives from neonatology-hemodynamics, pediatric cardiology, pediatric cardiac sonography, and neonatology-cPOCUS. This document provides (1) guidance on the purpose and rationale for both TNE and cPOCUS, (2) an overview of the components of a standard TNE and cPOCUS evaluation, (3) disease and/or clinical scenario-based indications for TNE, (4) training and competency-based evaluative requirements for both TNE and cPOCUS, and (5) components of quality assurance. The writing group would like to acknowledge the contributions of Dr. Regan Giesinger who sadly passed during the final revisions phase of these guidelines. Her contributions to the field of neonatal hemodynamics were immense.

The Utility of Screening Fetal Echocardiograms Following Normal Level II Ultrasounds in Fetuses with Maternal Congenital Heart Disease.

INTRODUCTION: Fetal echocardiograms (F-echo) are recommended in all pregnancies when maternal congenital heart disease (CHD) is present, even if there was a prior level II ultrasound (LII-US) that was normal. The goal of this study was to evaluate if any diagnosis of a critical CHD was missed in a fetus with maternal CHD who had a normal LII-US. METHODS: A retrospective chart review of all F-echoes where the indication was maternal CHD between 1/1/2015 to 12/31/2022 was performed. Fetuses were included if they had a LII-US that was read as normal and had an F-echo. Critical CHD was defined as CHD requiring catheterization or surgical intervention < 1 month of age. RESULTS: A total of 296 F-echoes on fetuses with maternal CHD were evaluated, of which 175 met inclusion criteria. LII-US was performed at 19.8 ± 2.9 weeks gestational age and F-echo was performed at 24.2 ± 2.8 weeks gestational age. No patient with a normal LII-US had a diagnosis of a critical CHD by F-echo (negative predictive value = 100%). Evaluating those patients that had a negative LII-US, ten patients were diagnosed with non-critical CHD postnatally (negative predictive value = 94.3%). F-echo correctly diagnosed two of the ten missed LII-US CHD. CONCLUSIONS: Critical CHD was not missed with a normal LII-US in this at risk population. F-echo also missed the majority of CHD when a LII-US was read as normal. A cost-benefit analysis of screening F-echo in fetuses with maternal CHD should be conducted if a normal LII-US has been performed.

Does Legislation Impede Data Sharing in Australia Across Institutions and Jurisdictions? A Scoping Review.

In Australia, regulations governing data, including formal legislation and policies promulgated by private and public agencies, are often seen as a barrier to data sharing. This sharing can include between institutions, as well as across jurisdictional borders in a federated jurisdiction such as Australia. In some cases, these regulations place a barrier to sharing data across borders or between institutions without a prerequisite requirement. In other cases, these regulations may be perceived as a justification not to share data. The objective of this review was to analyse published literature from Australia to see what regulations were used to justify not sharing data, along with any other factors that might discourage data sharing. We searched PubMed, Scopus and Web of Science for empirical and policy articles discussing data sharing in Australia. We then filtered these results via abstract and conducted a full text assessment to include 33 articles for analysis. Although there are a few areas of notable regulatory divergence with respect to legislation governing health data, most regulations in Australia are relatively consistent. Further, the absence of uniform ethics approval between sites in different states was frequently cited as a barrier to data sharing.

An ethical code for collecting, using and transferring sensitive health data: outcomes of a modified Policy Delphi process in Singapore.

One of the core goals of Digital Health Technologies (DHT) is to transform healthcare services and delivery by shifting primary care from hospitals into the community. However, achieving this goal will rely on the collection, use and storage of large datasets. Some of these datasets will be linked to multiple sources, and may include highly sensitive health information that needs to be transferred across institutional and jurisdictional boundaries. The growth of DHT has outpaced the establishment of clear legal pathways to facilitate the collection, use and transfer of potentially sensitive health data. Our study aimed to address this gap with an ethical code to guide researchers developing DHT with international collaborative partners in Singapore. We generated this code using a modified Policy Delphi process designed to engage stakeholders in the deliberation of health data ethics and governance. This paper reports the outcomes of this process along with the key components of the code and identifies areas for future research.

Utility of Screening Fetal Echocardiograms at a Single Institution Following Normal Obstetric Ultrasound in Fetuses with Down Syndrome.

Fetal echocardiograms (F-echo) are recommended in all pregnancies when the fetus has Down syndrome (DS) even if there was a prior obstetric scan (OB-scan) that was normal. The utility of a screening F-echo in this high-risk population when an OB-scan is normal is unknown. Goal of this study was to evaluate if any diagnosis of a critical congenital heart disease (CHD) was missed in a fetus with DS who had a normal OB-scan. Secondary goal was to determine if any CHD was missed postnatally when an OB-scan was read as normal. Retrospective chart review of all fetuses that had a F-echo whose indication was DS between 1/1/2010 to 6/30/2022 was performed. Fetuses were included if they had an OB-scan that was read as normal and had a F-echo. Postnatal transthoracic echocardiogram (pTTE) was reviewed when available. Critical CHD was defined as CHD requiring catheterization or surgical intervention < 1 month of age. One hundred twenty-two F-echo on fetuses with DS were evaluated, of which 48 met inclusion criteria. OB-scan was performed at 20.4 ± 4.5 weeks gestational age and F-echo was performed at 24.0 ± 4.6 weeks gestational age. No patient with a normal OB-scan had a diagnosis of a critical CHD by F-echo (n = 48, negative predictive value = 100%). Evaluating those patients that had an OB-scan and a pTTE (n = 38), 14 patients were diagnosed with CHD (muscular ventricular septal defect (VSD) n = 5, perimembraneous VSD n = 3, secundum atrial septal defect (ASD) n = 2, primum ASD n = 1, transitional atrioventricular septal defect (AVSD) n = 2, and aortic valve abnormality n = 1; negative predictive value = 63.2%). F-echo correctly diagnosed 4 of the 14 missed OB-scan CHD (perimembraneous VSD n = 2, muscular VSD n = 1, and transitional AVSD n = 1). Critical CHD was not missed with a normal OB-scan in this high-risk population. F-echo also missed the majority of CHD when an OB-scan was read as normal. The cost/benefit of screening F-echo in fetuses with DS should be evaluated if a normal OB-scan has been performed, considering all these patients would have a pTTE performed per guidelines.

When Will Death Be? Legal Considerations and Regulatory Safeguards in Predictive Modelling Applications for End-of-Life Care.

Advance care planning (ACP) is generally considered as valuable in guiding treatments that are aligned with patients' preferences. Despite its benefits, there are some practical and legal difficulties in its implementation. Predictive modelling is increasingly used in clinical decision-making, for example, in predicting patients' life expectancy, thus enabling clinicians to initiate timely ACP conversations. This development could transform the way end-of-life conversations are implemented. In this article we advocate for the use of predictive modelling in assisting clinicians to initiate ACP conversations provided several safeguards are in place to address ethical concerns that arise. Predictive modelling applications resolve several practical and legal difficulties in conducting end-of-life conversations. Ethical concerns such as explicability, accountability, trustworthiness and reliability of these models in clinical settings are important considerations. However, safeguards are needed to address these ethical concerns to ensure the models are appropriately supportive of patient needs and interests.

Health Technology and Big Data: Social Licence, Trust and the Law.

Technology is empowering advances in health care, extending beyond the clinical interface to the collection, collation and use of personal data. While this advance has the potential for population-wide benefits, there are legal and ethical challenges which carry the risk of both individual and collective harms. This section critically appraises the existing approach to the governance of health data in Australia. This approach is grounded in the principles of autonomy, privacy and respect for individual choice. This section then identifies the broader imperatives of social good, public health, improvement of outcomes and advancement of knowledge and the importance of balancing individual and collective interests. Central to this discussion are the concepts of social licence and avoiding ethical debt. A significant challenge to the appropriate sharing and use of health data are the existing regulatory barriers (both perceived and actual) and these are explored in some detail.

Ethical and regulatory implications of the COVID-19 pandemic for the medical devices industry and its representatives.

The development and deployment of medical devices, along with most areas of healthcare, has been significantly impacted by the COVID-19 pandemic. This has had variable ethical implications, two of which we will focus on here. First, medical device regulations have been rapidly amended to expedite approvals of devices ranging from face masks to ventilators. Although some regulators have issued cessation dates, there is inadequate discussion of triggers for exiting these crisis standards, and evidence that this may not be feasible. Given the relatively low evidence standards currently required for regulatory approval of devices, this further indefinite reduction in standards raises serious ethical issues. Second, the pandemic has disrupted the usual operations of device representatives in hospitals, providing an opportunity to examine and refine this potentially ethically problematic practice. In this paper we explain and critically analyse the ethical implications of these two pandemic-related impacts on medical devices and propose suggestions for their management. These include an endpoint for pandemic-related adjustments to device regulation or a mechanism for continued refinement over time, together with a review of device research conducted under crisis conditions, support for the removal and replacement of emergency approved devices, and a review of device representative credentialling.

Usefulness of Postnatal Echocardiograms in Patients with Omphaloceles Who Previously Had a Normal Fetal Echocardiogram.

INTRODUCTION: Neonates with omphaloceles routinely have a transthoracic echocardiogram (TTE) performed due to a high association with congenital heart defects (CHD). The utility of a TTE in these patients with a normal fetal echocardiogram is unknown. The primary objective of this study was to determine whether a critical CHD diagnosis was missed in patients with an omphalocele who had a normal fetal echocardiogram. The secondary objective of the study was to determine whether any CHD diagnosis was missed postnatally when a fetal echocardiogram was read as normal. METHODS: A retrospective chart review was performed of patients with omphaloceles born between January 1, 2008, and June 30, 2020. Patients were included if they had a fetal echocardiogram that was read as normal and had a postnatal echocardiogram performed. Baseline demographics, postnatal data echocardiographic findings, and hospital course were collected. Critical CHD was defined as CHD requiring neonatal cardiac intervention. RESULTS: Fifty-six fetal echocardiograms on patients with omphaloceles were performed, of which 24 patients met the inclusion criteria. No patient was diagnosed with a critical CHD postnatally (negative predictive value [NPV] = 100%). Two patients were diagnosed with ventricular septal defects (VSD) postnatally (NPV = 91.7%). One of the VSDs required closure with a patch at 4 months of life, while the other, a small muscular VSD, closed spontaneously within the first year of life. Both patients had a murmur on exam during their initial hospital stay. The patient that required surgery also had an abnormal electrocardiogram and chest X-ray. There were no mortalities due to cardiac causes in these patients. CONCLUSION: Critical CHD was not missed on any patient with an omphalocele who had a normal fetal echocardiogram. All other patients with omphaloceles who had CHD diagnosed postnatally had an abnormal clinical finding on postnatal evaluation. The routine performance of a postnatal TTE in patients with an omphalocele who had a normal fetal echocardiogram may not be needed in those with a normal clinical workup. Further studies evaluating echocardiographic imaging recommendations are needed to maximize care and optimize resource allocation in this complex patient population.

Regulation of AI in Health Care: A Cautionary Tale Considering Horses and Zebras.

The introduction of Artificial Intelligence (AI) into health care has been accompanied by uncertainties and regulatory challenges. The establishment of a regulatory framework around AI in health is in its infancy and the way forward is unclear. There are those who argue that this represents a concerning regulatory gap, while others assert that existing regulatory frameworks, policies and guidelines are sufficient. We argue that perhaps the reality is somewhere in between, but that there is a need for engagement with principles and guidelines to inform future regulation. However, this cannot be done effectively until there is more clarity around the reality of AI in health and common misconceptions are addressed. This paper explores some of these misconceptions and argues for a principled approach to the regulation of AI in health.

Initial fetal to initial postnatal echocardiogram in uncomplicated atrioventricular septal defects: Do significant changes occur?

BACKGROUND: Yield of serial echocardiography in fetuses with atrioventricular septal defects (fAVSD) has not been well defined. The goal of this study was to document if any major changes occurred from initial fetal to initial postnatal echocardiogram in uncomplicated fAVSD. METHODS: fAVSD were excluded if initial fetal scan documented complex CHD or any concerns. Changes in ventricular function, valvular regurgitation, or diagnosis between first fetal and first postnatal echocardiogram were recorded. RESULTS: Fifty-seven fAVSD met criteria. Ninety-six fetal echocardiograms were done in 57 patients. Initial fetal scan was performed at 24.3 ± 3.7 weeks of estimated gestational age. All fAVSD had normal function, 38 had no atrioventricular valve regurgitation (AVVR), and 19 had mild AVVR. First postnatal echocardiogram was performed at 6.3 ± 15.3 days. Fifty-six patients had normal function, 1 patient had mild dysfunction, 16 patients had no AVVR, 36 had mild AVVR, and 5 had moderate AVVR. Three patients (5%) had an improvement in AVVR by one degree, 27 patients (47%) had no change in AVVR, 24 patients (42%) had an increase in AVVR by one degree, and 3 patients (5%) had an increase in AVVR by two degrees. There was no major missed anatomical diagnosis from first prenatal to first postnatal echocardiogram. CONCLUSION: In fAVSD that had no concerns on their initial fetal echocardiogram, the majority of patients had no major changes noted between their initial fetal echocardiogram and their first postnatal echocardiogram. Repeat fetal echocardiograms may not necessarily be needed in this cohort of patients.

Health Care, Technology and Innovation: What's Law Got to Do with It?

Health care is consistently evolving and improving. We have moved from a time when health care was a true mystery and many conditions were deemed untreatable to one where the general population rejects any idea that health care is likely to harm or do anything other than cure illness. Central to this evolution has been the introduction of technology into health care. While this undeniably represents a much-desired inclusion in medical treatment, it poses specific regulatory challenges. Each of these challenges warrants specific and detailed analysis and critique. This column explores the intersection between the law, technology and health care and provides insight into how these can (and do) interact. It is an introductory discussion that serves to raise questions for further consideration.

Breast Density Notification: An Australian Perspective.

Breast density, also known as mammographic density, refers to white and bright regions on a mammogram. Breast density can only be assessed by mammogram and is not related to how breasts look or feel. Therefore, women will only know their breast density if they are notified by the radiologist when they have a mammogram. Breast density affects a woman's breast cancer risk and the sensitivity of a screening mammogram to detect cancer. Currently, the position of BreastScreen Australia and the Royal Australian and New Zealand College of Radiologists is to not notify women if they have dense breasts. However, patient advocacy organisations are lobbying for policy change. Whether or not to notify women of their breast density is a complex issue and can be framed within the context of both public health ethics and clinical ethics. Central ethical themes associated with breast density notification are equitable care, patient autonomy in decision-making, trust in health professionals, duty of care by the physician, and uncertainties around evidence relating to measurement and clinical management pathways for women with dense breasts. Legal guidance on this issue must be gained from broad legal principles found in the law of negligence and the test of materiality. We conclude a rigid legal framework for breast density notification in Australia would not be appropriate. Instead, a policy framework should be developed through engagement with all stakeholders to understand and take account of multiple perspectives and the values at stake.

Consumer Law, Technology and Health Care: A Shift in Focus, a Panacea or a Confounder?

With the increasing role of technology in health care the clinical environment is becoming more complex and it is important to recognise that there is now a significant commercial player on the clinical stage. The relationship between the patient and the manufacturers/distributers of this technology is not a clinical one, neither is it necessarily a traditional consumer one as there is an absence of direct interaction. When the patient suffers harm as a result of faulty technology, they understandably seek recompense for that harm; and while the traditional approach of negligence law is open to them, there is also a role for consumer law. This column explores three high-profile decisions in which consumer law was applied to instances of patient harm and asks the question whether, at the intersection of technology and health care, consumer law represents a shift in focus, a panacea or a confounder.

Serial fetal echocardiograms in hypoplastic left heart syndrome fetuses: Does it affect immediate post-natal care?

Guidelines recommend serial fetal echocardiograms when congenital heart disease is diagnosed. Necessity, timing, and frequency of serial echocardiograms are based on clinical judgment. Fetuses with hypoplastic left heart syndrome (fHLHS) may undergo multiple studies prior to birth. Goal of this study was to determine if the need for unexpected, emergent cardiac interventions were required immediately post-natally, if there were no concerns on initial fetal echocardiogram. METHODS: Fetal echocardiograms performed between 2006 and 2018 on fHLHS were reviewed. fHLHS were excluded if initial fetal scan documented any other concerns. Unexpected, emergent catheterization or surgical procedures, intubation, or inotropic support within the first 72 h of life were recorded. RESULTS: Total of 80 fHLHS were reviewed. Thirty-two fHLHS were excluded because of concerns on the initial fetal echocardiogram. Sixteen fHLHS had one scan, 14 had two scans, 13 had three scans, and 5 had four scans. No patient underwent an unexpected, emergent catheterization or surgical procedure within the first 72 h of life. Seven patients required intubation and 1 patient received inotropic support within the first 72 h of life. CONCLUSION: No fHLHS underwent an unexpected, emergent catheterization or surgical procedure within the first 72 h of life if the initial fetal echocardiogram had no significant concerns. Medical interventions did occur immediately post-natally, but could not be directly attributed to a missed fetal cardiac diagnosis. Frequent serial fetal echocardiograms may not necessarily be needed to predict the need for an unexpected, emergent procedure.