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. 2025 Mar 14;17(2):265–278. doi: 10.1007/s41649-024-00354-w

The Ethics of Fetal Cardiac Intervention

Jonathan Tze Liang Choo 1,✉
PMCID: PMC11982001  PMID: 40225803

Abstract

Advances in fetal cardiac ultrasound technologies and refinements in cardiac catheterization techniques have made fetal cardiac intervention a reasonable option for fetuses with cardiac abnormalities such as fetal aortic stenosis and fetal hypoplastic left heart syndrome. These procedures — fetal aortic balloon valvuloplasty and fetal atrial stenting — are performed on the physical body of the mother for the benefit of the fetus, and yet carry risks to both mother and fetus. This paper reviews the ethics of fetal cardiac intervention in fetal left heart disease. It provides the ethical underpinnings for the development and performance of these procedures and outlines a practical ethical framework for counselling families in the face or these cardiac abnormalities. There is a need for careful case selection and a need to review these cases after fetal cardiac intervention. The establishment of registries to collect pre-procedural data and to monitor short and long-term procedural outcomes is expected to strengthen the evidence for ethical decision-making.

Keywords: Fetal cardiology, Fetal catheter intervention, Aortic stenosis

Introduction

There have been tremendous advances in fetal ultrasound technology, and fetal cardiac diagnoses are now made with a high degree of accuracy and precision. The practice of fetal cardiology has shifted from diagnosis of congenital cardiac abnormalities towards delivery planning and the optimization of perinatal care. Furthermore, the tools for cardiac intervention have become more refined in the last 3 decades (Nykanan 2020). Building on these advances, fetal cardiac intervention has now become a reasonable option for babies with congenital heart disease (McElhinny et al. 2010). The fetal cardiac interventional procedures, fetal aortic valvuloplasty, and fetal inter-atrial stenting, considered in this ethical review, are not experimental but have had success in a select group of fetuses with fetal aortic stenosis and varying degrees of hypoplastic left heart syndrome (Donofrio et al. 2014). These fetal procedures are, however, not widely available but are limited to being performed in large-volume paediatric cardiac centres with strong obstetric and multidisciplinary support. The evidence for these interventions had evolved without a randomized controlled trial. With these rapid advances, ethical concerns have understandably emerged (Mavroudis 2011). This paper will discuss the ethics of performing fetal cardiac interventions in the current era, provide the philosophical underpinnings, and suggest an ethical framework for counselling families, as the field continues to evolve.

A Case Study of Fetal Aortic Stenosis

A fetus was diagnosed with moderate aortic stenosis at a gestational age of 20 weeks and referred to fetal cardiology for further management. At the 20-week scan, the fetal left ventricle was noted to be adequately sized for biventricular circulation. At 28 weeks gestation, there was reduced flow across the aortic valve (Fig. 1), and the left ventricle was noted to be hypertrophied with a smaller-sized ventricular cavity. The case was discussed with fetal cardiologists and obstetricians familiar with in-utero fetal cardiac intervention and deemed suitable for fetal aortic valvuloplasty. However, the procedure could not be arranged at the local centre. The mother had been unwilling to travel to a centre able to perform fetal aortic valvuloplasty due to expected high financial costs and the lack of social support. The fetus was delivered at 37 weeks gestation and post-natal echocardiogram showed critical aortic stenosis. The left ventricle was significantly hypertrophied and there was echogenicity of the left ventricular papillary muscles indicating the presence of left ventricular endocardial fibroelastosis. The baby underwent balloon aortic valvuloplasty on the second day of life. Balloon aortic valvuloplasty was successfully performed with relief of the valvular obstruction but the baby collapsed minutes after the procedure, requiring extracorporeal membranous oxygenation (ECMO) support and demised 2 weeks later from sepsis. Although the actual cause of the post-procedural collapse was unclear at ECMO cannulation and at post-mortem, left ventricular diastolic dysfunction secondary to endocardial fibroelastosis was thought to be a contributory factor.

Fig. 1.

Fig. 1

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A grey-scale image with colour compare mode overlay demonstrating a thickened and stenotic aortic valve with turbulent flow across the stenotic valve in a fetus at 28 weeks gestation

Fetal Cardiac Intervention — The Current State of Affairs with a Focus on Fetal Left Heart Disease

There is a spectrum of congenital left heart obstructive disease, ranging from aortic stenosis to hypoplasia of the left heart; with hypoplasia of the left heart at the most severe end of this spectrum. Over the years, fetal cardiologists have developed a clearer understanding of this spectrum of structural heart disease (Donofrio et al. 2014) with fetal cardiac ultrasound providing an understanding of cardiac morphological and hemodynamic changes through the course of gestation. Compared to interventions on the fetal right heart (for example, fetal pulmonary balloon valvuloplasty), there has been more experience with interventions for fetal left heart disease around the world (for example, fetal aortic stenosis and varying degrees of hypoplasia of the left heart). These ethical discussions in this paper are therefore confined to fetal left heart disease. When fetal cardiac intervention is mentioned, fetal aortic valvuloplasty most commonly comes to mind (Mäkikallio et al. 2006). Fetal atrial stenting is being considered for fetuses with more advanced or severe forms of fetal left heart disease (Mallmann et al. 2020).

Unlike other fetal therapies, such as the in-utero management of myelomeningoceles (Adzick et al. 2011), fetal cardiac interventions were introduced into clinical practice without a randomized clinical trial (Kovacevic et al. 2021). At present, these fetal cardiac interventional procedures are only available in a few specialized centres around the world. For most families, who have had a diagnosis of fetal aortic stenosis or fetal left heart disease, there is a burden of knowledge, and most cases are conservatively managed with the option for fetal cardiac intervention not available in their locality. While there has been work done on the natural history of fetal aortic valve stenosis (Simpson and Sharland 1997), it has been difficult to determine the optimal management of fetal aortic stenosis, as randomized trials would have had been fraught with logistic and ethical concerns. The fetal cardiac community has demonstrated that fetuses with aortic stenosis may develop hypoplastic left heart syndrome as the reduced flow across the left ventricular outflow tract results in abnormal ventricular development (Fig. 2). Clearly, close monitoring and delivery at tertiary paediatric cardiac centres with well-developed catheter intervention and cardiac surgical programmes is recommended. However, overall, the optimal prenatal management with respect to fetal cardiac intervention procedures remains unclear (Malhotra et al. 2010).

Fig. 2.

Fig. 2

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Serial echocardiograms demonstrating evolving hypoplasia of the left heart in a fetus with initial aortic stenosis (with the designated gestational age in weeks (w))

With respect to fetal aortic stenosis, central to the clinical decision-making in fetal life are factors such as the severity of aortic stenosis, fetal left ventricular function, and the presence of endocardial fibroelastosis, the size of the interatrial communication and the condition of the fetal lungs. As alluded to previously, at the time of writing this paper, two main types of fetal interventional procedures are performed to mitigate the natural history of fetal aortic stenosis and fetal left heart disease — fetal aortic valvuloplasty and fetal atrial stenting. These procedures are, however, performed for different reasons and with different therapeutic goals. Fetal aortic valvuloplasty is performed to improve the forward flow across the aortic valve (Rodriguez et al. 2019), thereby promoting the growth of the developing left ventricle (and preventing progression towards hypoplastic left heart syndrome). It is important to note that hypoplasia of the left heart is associated with significant morbidity and a poorer long-term outcome as compared to aortic stenosis with biventricular circulation (Siffel et al. 2015). Overall Kaplan–Meier survival estimates are 55% at 10 years and 33% at 15 years for hypoplasia of the left heart. Long-term outcomes have, however, improved in the current era in tandem with improvements in intensive care, cardiac catheterization, and surgical techniques (Best et al. 2021). The likelihood of a biventricular outcome following fetal aortic valvuloplasty is about 60% in the current era (Friedman et al. 2018). Fetal inter-atrial stenting (Marshall et al. 2004) is performed to decompress the fetal left atrium and as such to reduce the effect of fetal left atrial hypertension on the developing fetal lungs (thereby promoting fetal lung development). The technical success of fetal atrial stenting has been reported in 65% of selected cases with the procedural fetal demise occurring in 13% of cases (Yilmaz et al. 2024). Some centres perform fetal atrial septoplasty (enlarging the size of the fetal oval foramen without leaving a stent in situ).

Fundamentally, these procedures would require puncturing the maternal abdomen (transabdominal), uterine cavity (transuterine), and fetal chest to access the fetal heart (Fig. 3). In the case of fetal aortic valvuloplasty, a balloon catheter is then inserted through the left ventricular cavity and across the aortic valve over a guidewire. The balloon is inflated to relieve the stenosis and the balloon catheter is then removed. In fetal atrial stenting, the fetal right atrium is punctured and balloon-mounted stent is passed over a guide wire and positioned across the interatrial septum. The balloon is inflated and the stent is left in place after the deflated balloon and guidewire are removed. Expectedly, these procedures carry significant risks for the fetus and the mother. Fetal risks include haemopericardium, fetal arrhythmia, prematurity (10% risk), and in-utero demise (4 – 8%) (Pickard et al. 2020). With fetal atrial stenting, there is a risk of stent migration and embolization. Maternal risks include premature rupture of membranes, maternal adverse drug reactions, and pre-term labour. These procedures also involve maternal sedation or anaesthesia. Overall, the maternal risks are relatively low. In 128 fetal cardiac intervention cases including 94 cases of aortic balloon valvuloplasty and 14 interatrial stent placements, the risk of placental abruption was 1.1% specifically for balloon aortic valvuloplasty, and the incidence of post-operative pain in the cohort was 6.3% (Rebizant et al. 2021).

Fig. 3.

Fig. 3

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Maternal transabdominal and transuterine approach to fetal cardiac intervention. (Redrawn from Saia 2021)

Technical factors such as team expertise and dynamics determine the availability of the procedure. Also, the ability of the cardiothoracic team at each centre to perform surgeries such as the Ross procedure (pulmonary autograft to replace the diseased aortic valve and a pulmonary homograft to replace the native pulmonary valve) or Norwood procedure (a series of staged surgeries for single ventricle palliation of hypoplasia of the left heart) are also factors that influence the decision to develop and offer cardiac interventional procedures for aortic stenosis in fetal life. Finally, it is also important to ensure that the other aspects of medical care are also available to support the care of the individual with congenital aortic stenosis throughout his or her life (for example, availability of a good cardiac adult transition programme and the availability of adult valve replacement options).

The Current Practice in Singapore

State-of-the-art fetal imaging technologies and expertise are available in Singapore. Cardiothoracic surgeons in Singapore are able to perform Ross procedures and Norwood surgeries. However, there are no fetal cardiac intervention programmes in the country. At diagnosis, the natural history and management options, including the possibility of fetal cardiac intervention in suitable cases, at overseas centres, are explained to the mother (and indeed to the expectant father as well). If the family requests an overseas opinion in view of fetal intervention, we have referred these patients to the appropriate centres overseas. The paediatric cardiac services in Singapore have well-developed post-natal cardiac interventional programmes. Currently, cases of prenatally diagnosed aortic stenosis are re-assessed after birth and the optimal definitive interventional and surgical plan is then determined postnatally.

Ethical Principles in Fetal Cardiac Intervention

In considering the ethics of fetal cardiac intervention, we start with a fundamental discussion on the fetus as a patient. There has been no consensus from the theological, anthropological, social, legal, ethical, and medical perspectives (McCullough and Cervenak 2018). While the issue of fetal personhood is a particularly vexing one (Wiesemann 2018), I would suggest that the main issue in beginning our ethical discussions is whether a fetus can indeed be a patient. John Gregory (1724 – 1773), a Scottish physician and moral philosopher made early descriptions of the patient – physician relationship (McCullough 2006). The ethical concept of the human being as a patient was then introduced into the history of western medical ethics (Ashworth 2003). Being a patient is therefore an invented social role (McCullough 1998, 179). Fetuses become patients when they present (or are presented) to a healthcare professional and there exist clinical interventions that are reliably expected to benefit clinically the fetus and the future child that it can become (parenthesis my own) (McCullough and Cervenak 2018). McCullough and Chervenak argued that independent moral status is not required for an entity to be considered a patient. They cite examples of patients with severe neurological disease (patients nonetheless). Such entities may be a “member of the kingdom of ends”, a Kantian (Immanuel Kant 1724 – 1804) concept of moral status but may not be “free from substantial control or coercion of others”, a Millian (John Stuart Mill 1806 – 1873) notion of moral status (McCullough and Cervenak 2018). A more pragmatic approach is to consider a relational conception of moral status, in which a fetus has a dependent moral status (not an independent moral status) and in which there remains a duty to care for such an entity.

I have argued that a fetus can therefore be a patient. A physician has a duty to care for his/her patient and should a fetal cardiologist make a diagnosis of fetal aortic stenosis or fetal hypoplasia of the left heart, he or she should take appropriate care in applying his or her skills in providing advice and in the pre-natal and perinatal management. But the fetus is not a separate patient from its mother because the fetus resides within the physical body of its mother (Schmitz et al. 2018). The care of the fetus cannot be reasonably separated from the care of its mother. Just as a fetal cardiologist has a duty of care to the fetus, the fetal cardiologist has a similar duty of care to the mother. This duty of care includes the duty to make a correct diagnosis, a duty to provide the appropriate advice and the duty to provide reasonable treatment options for the fetal cardiac condition and for the overall benefit of the pregnancy (inclusive of the mother).

To circumvent the issue of fetal therapies resulting in maternal complications, would there be an option of delivering the fetus early so that the medical team would be able to manage the infant ex-utero? Based on our ability to manage hypoplastic left heart syndrome in the pre-term infant, this would be a less conventional approach. The development of the fetal lungs is important in the perinatal survival of hypoplastic left heart syndrome. The survival of pre-term infants with hypoplasia of the left heart is significantly poorer (Siffel et al. 2015). Therefore, it appears that in the decision for or against fetal cardiac intervention, the interests of the fetus and mother may diverge (Halliday 2016). There is an obvious tension between fetal benefits and maternal risks. How should this decision be made?

A key ethical consideration is that of the autonomy of the mother (Beauchamp and Childress 2013). A pregnant mother has a right to make decisions regarding her pregnancy choices. While the fetus is the patient, the fetus does not have any capacity to make its own decisions. It is fully reliant on its mother to act in its best interests. The fetus is, however, within the physical body of its mother. Clearly, a fetal interventional procedure would have to be performed on the mother to aid the fetus, with a risk of complications or harm to the mother. The risks of the fetal cardiac intervention to the mother have been described in an earlier section. As in the case presented, the mother has the right to refuse such intervention in the face of maternal risks. She has the responsibility to make the decision in pregnancy but also lives with the consequences of such a decision. Therefore, I argue that providing her with the accurate evidence-based information is of utmost importance.

The next issue that we will consider is the effectiveness of the procedure and likelihood of influencing the natural history of the disease positively — does the cardiac community have a clear understanding of the long-term outcomes of fetal aortic valvuloplasty or fetal atrial stenting? There has been a call for registries to be set-up to monitor outcomes in fetal cardiac interventions (Rodriguez et al. 2019). I would expect these registries to provide more clarity regarding case selection, procedural complications, and long-term effect on the natural history of fetal aortic valvuloplasty in post-natal life (Moon-Grady et al. 2015). Furthermore, at the time of writing, the data is unclear with respect to which fetuses should not be offered fetal aortic valvuloplasty performed in earlier gestation but rather have fetal atrial septal stenting performed instead in more advanced fetal left heart obstructive disease (Jantzen et al. 2017). Clear and accessible information is required for mothers and their doctors to make decisions on the appropriateness of fetal cardiac intervention in a shared decision-making process.

Finally, we will discuss on resource and procedural developmental concerns in the management of the spectrum of severe aortic stenosis in pre-natal and post-natal life. While there is further development in the procedural safety of fetal aortic valvuloplasty, given the risks of prenatal intervention, there should be a similar call for the development of neonatal cardiac intervention at earlier gestations. The development of neonatal cardiac interventions for low birthweight infants is not a new consideration. In recent years, closure of arterial ducts has been performed using small sized devices such as the Piccolo device (Morray et al. 2023). Consideration should be made for developing balloon aortic valvuloplasty or atrial septal stenting in low birthweight infants while mitigating the risks of vascular access, environmental control, and catheter manipulation. Our experience with poorer outcomes in pre-term infants with hypoplasia of the left heart may in part be due to the inability to perform catheter procedures in these patients. The skills, catheters, and devices developed will be more transferable to other ex-utero vascular and cardiac interventional procedures. And arguably, these would be more acceptable developments as evolutionary innovations rather than revolutionary procedural leaps. In our attempt to modify the natural history of the spectrum of antenatally diagnosed obstructive left heart disease, the evidence should include a comparison of neonatal intervention with antenatal intervention in a perinatal analysis.

While discussing procedural development, it is important to consider the learning curve of the surgical or interventional team (Samples et al. 2024). This learning curve was evident in the Boston experience (Friedman et al. 2018) in which the procedural success had been 73% in the early cohort (2000 – 2008) and 94% in the later cohort (2009 – 2015). If the procedural volumes are low, there would be difficulty getting past the learning curve. In some ways, medical simulation may be of value, but interventionalists understand the need for consistent actual hands-on to maintain their skillsets and develop the techniques further to improve safety and quality. Given that fetal cardiac intervention involves coordination among physicians from various disciplines, a team learning curve may be even more difficult to negotiate with a larger number of key skillsets to develop within and between each sub-specialty.

It may be argued that from a resource management perspective, fetal cardiac interventions should only be performed in high-volume referral centres (Kang et al. 2020) identified in each geographical region (Samples et al. 2024). This is the approach in North America. While such an approach may be of merit from a technical and resource perspective, there is a social cost to prospective parents as mothers may have to travel some distance for fetal cardiac interventional procedures. This approach may be not applicable to Asia or indeed South East Asia, where several densely populated countries are located close to one another. Travel across national boundaries would be clearly onerous and disruptive to the family. Furthermore, there remains a question on how the global cardiac community should organize such care distribution across national boundaries and if there would be a consensus at all. Finally, it is interesting to note that there are geographical differences in the distribution of congenital heart disease; for example, in Asian populations, pulmonary outflow obstructive lesions were reported to be more common than left ventricular outflow obstructive lesions (van der Linde et al. 2011). An Asian registry should also be established should there be more cases of fetal cardiac intervention in Asia.

Further Reflections from Early Modern Philosophy

The works of the early modern philosophers emerged during a period of tremendous technological advancement and may guide our thinking during these times of rapid developments in Cardiology. Thomas Hobbes (1588 – 1679), the English philosopher and politician reflected on the responsibility of governments to provide for their citizens as a form of social contract (Courtland 2017). I would argue that the public healthcare system of each country should provide for therapeutic options in cases of fetal aortic stenosis that would allow for reasonable sustainable long-term outcomes. While, it may be that fetal cardiac interventions are performed on the fetuses in-utero, the range of therapeutic options should include post-natal interventions and surgeries to optimize outcomes for these children. A careful consideration of available resources and expertise should be made and a preference for post-natal intervention and surgical management may be an appropriate approach depending on these considerations. There remains a need to provide comprehensive and equitable care (Kang et al. 2020). The lack of adequate prenatal case-load has been one key reason why Singapore has yet to develop its own fetal cardiac intervention programme. Based on the epidemiological database from a fetal cardiology referral centre in Singapore, only 1 to 2 cases of fetal aortic stenosis are seen each year. These are typically mild with hearts that have well-developed and normal functioning left ventricles. The low case volume would make it difficult to develop skilled expertise for this complex fetal procedure and to maintain this expertise.

David Hume (1711 – 1776) was a Scottish philosopher and historian who wrote an extensive discourse on sympathy. While there are many different hermeneutical interpretations of the use of sympathy, empathetic responsiveness is an important aspect of his work (Agosta 2014). One should counsel prospective parents with empathy. Fetal aortic stenosis is a life-long disease, depending on the degree of progression of the aortic valve narrowing and the development of the left ventricle, in terms of size and function, individuals with aortic stenosis will have a range of estimated life expectancies and therapeutic needs. The fetal cardiologist should counsel with empathy, towards the mother, the family and demonstrate empathetic understanding with respect to the medical and surgical capabilities particularly in the more severe end of the spectrum of disease. There have been recognized differences in the positions of paediatricians and obstetricians with regard to the weight given to maternal perspectives and fetal indications in fetal therapies (Brown et al. 2004). The various subspecialties should be open to each other’s perspectives and work towards a pragmatic plan to manage the pregnancy in the case of fetal cardiac abnormalities.

Discussing Fetal Cardiac Interventions with Prospective Parents — An Ethical Framework

Mothers (and prospective fathers) should be given a choice regarding viable therapeutic options. Maternal autonomy (Beauchamp et al. 2013) is respected and facilitated when full disclosure is made. The process of informed consent is so important and utmost care must be taken in this clinical context (Salice et al. 2016). Complete transparency and disclosure to the prospective parents with regard to the procedural risks, potential benefits (in the short, medium, and long term), and limitations of current medical care (General Medical Council 2020). This is particularly important as there have been no multi-centred randomized trials in fetal cardiac intervention to date. Potential conflicts of interests should be disclosed particularly in these innovative procedures. Language used is important, keeping in mind to avoid putting weight on words that carry too much emotional burden (Mavroudis 2011). It is important to let the parents know that fetal cardiac interventions are not meant to be stand-alone curative procedures but that further interventions and procedures are expected such as repeat aortic valvuloplasty, aortic valve replacement surgeries, and staged palliative surgical procedures later in life.

While we have considered the philosophical aspects of fetal cardiac intervention above, an ethical framework will help bring ethical theory into praxis. The four-box tool kit (Jonsen et al. 2015) that was developed by Siegler to promote ethical reasoning in clinical practice may be applied as an ethical framework in consideration of fetal interventions (in this case, fetal cardiac interventions). The four areas for consideration in this approach are medical indications, patient preferences, quality of life issues, and contextual issues (Table 1).

Table 1.

An ethical framework applied to fetal cardiac intervention

Medical indications
• Likelihood of biventricular circulation
• Advantages to perinatal management
• Procedural risks to the mother
• Procedural risks to the fetus
• Option of delivery for neonatal management		 Patient preferences
• Does the mother (and prospective father) understand the procedure, risks of the procedure and expected modified history?
• Is the mother willing to undergo the procedure?

Quality of life

• Risk of neurodevelopmental delay

• Likelihood of requiring long-term medication e.g. anticoagulation with total cavopulmonary connection

• Exercise restrictions

Contextual issues

• Need to travel to large centres

• Financial issues

• Legal issues in different jurisdictions

• Religious and family values
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Medical indications: The fetal cardiac diagnosis, prognosis, and therapeutic aim of the fetal cardiac intervention should be clear. The potential short-, medium-, and long-term benefits of the procedure should be explained to the parents with respect to the natural history, highlighting the overall outcomes of hypoplasia of the left heart. The risks of the procedure to the mother should be explained. The procedural risks to the fetus should be explained. There should be a consideration for delivery of the fetus for medical treatment should the fetus be beyond the age of viability, depending on other clinical factors such as fetal weight and the degree of development of the fetal lungs.

Patient preferences: The mother has the responsibility to decide on the various management options (Roth 2000). These options would include fetal cardiac intervention, conservative in-utero management and active post-natal management, conservative in-utero management and post-natal management, delivery of the fetus and active post-natal management. Specifically, if a diagnosis of severe aortic stenosis or hypoplasia of the left heart is made, the option of termination of pregnancy should be explained to the mother based on the legal position in different jurisdictions. A clear and open discussion is important in this shared decision-making process.

Quality of Life issues should be discussed with the parents. There is a risk of neurodevelopmental delay associated with unfavourable in-utero haemodynamics, fetal cardiac intervention, perinatal management, and post-surgical management depending on the prevailing haemodynamics and occurrence of complications. There may be divergent views of quality of life. Parents, obstetricians, neonatologists, and cardiologists may have different perspectives. There is a need for more work in understanding differences on how each group perceives long-term outcomes and neurodevelopmental outcomes, particularly with antenatally diagnosed cardiac anomalies.

Contextual features should then be considered. These include the views of the prospective father and wider family, the availability of the procedure locally or regionally and the financial costs of the procedure. While in many other areas of medicine, it is unlikely for contextual features to be a key deciding factor in an ethical analysis, the relational nature of fetal care places a greater weight on this part of the clinical ethical review. I would expect the above four-box framework to bring greater clarity when counselling mothers and indeed families who have a fetus diagnosed with the spectrum of fetal left heart obstructive conditions such as aortic stenosis and hypoplasia of the left heart.

Conclusion

This case highlights the relevance of ethics to the care of patients in clinical practice. Ethical principles and ethical frameworks can guide us in the care of fetal cardiac patients. While it may be reasonable to offer fetal aortic valvuloplasty as the primary procedure in a select group of fetuses beyond the age of viability as the primary procedure to optimize their long-term cardiac outcomes, or fetal atrial stenting for fetuses with left heart obstructive disease and a restrictive atrial septum, in the current era, these procedures should be considered against the background of available resources to provide sustainable and reasonable care to fetuses and future children with these cardiac anomalies. It is probably best to perform these procedures at centres with sufficient caseload and resources. Multi-centred registries should be established to track fetal, neonatal, and long-term outcomes when fetal cardiac interventions are performed. These registries will strengthen the evidence for ethical decision-making. The alternative of neonatal cardiac intervention should be explored and developed in tandem with fetal cardiac intervention. It is likely that procedural developments in neonatal intervention would have greater applicability to a wider range of patients in the early neonatal period. Finally, each country should develop a strategy to mitigate the natural history of fetal aortic stenosis through a careful selection of prenatal/postnatal procedural interventions and post-natal cardiac surgical procedures.

Acknowledgements

The author acknowledges the contribution of Choo En Hui Danielle for the artwork, illustrations and figures in this paper.

Declarations

Competing Interests

The author declares no competing interests.

Ethics Approval

This paper satisfies the IRB requirements of the author’s institution.

Consent to Participate

Not applicable.

Consent for Publication

Not applicable.

Footnotes

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References

  1. Adzick, N. Scott, Elizabeth A. Thom, Catherine Spong, et al. 2011. A randomized trial of prenatal versus postnatal repair of myelomeningocele. New England Journal of Medicine 364:993–1004. 10.1056/NEJMoa1014379. [DOI] [PMC free article] [PubMed] [Google Scholar]
  2. Agosta, Lou. 2014. A Rumor of Empathy in Hume’s Many Uses of Sympathy. In A Rumor of Empathy: Rewriting Empathy in the Context of Philosophy, 9–30. Palgrave Macmillan. 10.1057/9781137465344_2. [Google Scholar]
  3. Ashworth, B. 2003. John Gregory and the background to medical philosophy. Journal of the Royal College of Physicians Edinburgh 32: 67–69. [PubMed] [Google Scholar]
  4. Beauchamp, T.L., and J.F. Childress. 2013. Respect for autonomy. In The Principles of Biomedical Ethics, 7th ed., 101–125. Oxford University Press. [Google Scholar]
  5. Best, Kate E., Nicola Miller, Elizabeth Draper, et al. 2021. The improved prognosis of hypoplastic left heart: a population-based register study of 343 cases in England and Wales. Frontiers in Pediatrics 9:635776. 10.3389/fped.2021.635776. [DOI] [PMC free article] [PubMed] [Google Scholar]
  6. Brown, Stephen D., Robert D. Truog, Judith A. Johnson, and andJeffrey L. Ecker. 2006. Do differences in the American Academy of Pediatrics and the American College of Obstetricians and Gynecologists positions on the ethics of maternal-fetal interventions reflect subtly divergent professional sensitivities to pregnant women and fetuses? Pediatrics 117 (4): 1382–1387. 10.1542/peds.2004-2724. [DOI] [PubMed] [Google Scholar]
  7. General Medical Council. 2020. The information you give patients. In Decision making and consent: Guidance on professional standards and ethics for doctors, 10–13. UK: General Medical Council. [Google Scholar]
  8. Courtland, Shane D. 2017. Hobbesian right to healthcare. Journal of Applied Philosophy 34 (1): 99–113. 10.1111/japp.12124. [Google Scholar]
  9. Donofrio, M., A. Moon-Grady, L.K. Hornberger, et al. 2014. Diagnosis and treatment of fetal cardiac disease: A scientific statement from the American Heart Association. Circulation. 10.1161/01.cir.0000437597.44550.5d. [DOI] [PubMed] [Google Scholar]
  10. Friedman, K. G., L. A. Sleeper, L. R. Freud, et al. 2018. Improved technical success, postnatal outcome and refined predictors of outcome for fetal aortic valvuloplasty. Ultrasound in Obstetrics and Gynecolology. 52 (2): 212–220. 10.1002/uog.17530. [DOI] [PubMed] [Google Scholar]
  11. Halliday, Sam. 2016. Comparative Analysis. In Autonomy and Pregnancy: A Comparative Analysis of Compelled Obstetric Intervention, 206–207. Routledge. [Google Scholar]
  12. Jantzen, David W., Anita Moon-Grady, Shaine A. Morris, et al. 2017. Hypoplastic left heart syndrome with intact or restrictive atrial septum. International Fetal Cardiac Intervention Registry. Circulation 136:14. 10.1161/CIRCULATIONAHA.116.025873. [DOI] [PubMed] [Google Scholar]
  13. Jonsen, Albert R., Mark Siegler, and William J. Winslade. 2015. The four topics. In Clinical Ethics: A practical approach to Ethical Decisions in Clinical Medicine, 8th ed., 3–4. Elsevier McGraw-Hill. [Google Scholar]
  14. Kang, Sok-Leng, Edgar Jaeggi, Greg Ryan, and Rajiv R. Chaturvedi. 2020. An overview of contemporary outcomes in fetal cardiac intervention: A case for high-volume superspecialization? Pediatric Cardiology 41 (3): 479–485. 10.1007/s00246-020-02294-2. [DOI] [PubMed] [Google Scholar]
  15. Kovacevic, Alexander, Michael Elsasser, Herbert Fluhr, et al. 2021. Counseling for fetal heart disease – current standards and best practice. Translational Pediatrics 10 (8): 10.21037/tp-20-181. [DOI] [PMC free article] [PubMed]
  16. Mäkikallio, Kaarin, Doff B. McElhinny, Jami C. Levine, et al. 2006. Fetal aortic valve stenosis and the evolution of hypoplastic left heart syndrome: Patient selection for fetal intervention. Circulation 113:11. 10.1161/CIRCULATIONAHA.105.588194. [DOI] [PubMed] [Google Scholar]
  17. Malhotra, Atul, Samuel Menahem, and Lynn Gilliam. 2010. Ethical issues in fetal management: a cardiac perspective. International Journal of Pediatrics. 2010:857460. 10.1155/2010/857460. [DOI] [PMC free article] [PubMed] [Google Scholar]
  18. Mallmann, M.R., U. Herberg, I. Gottschalk, et al. 2020. Fetal cardiac intervention in critical aortic stenosis with severe mitral regurgitation, severe left atrial enlargement, and restrictive foramen ovale. Fetal Diagnosis & Therapy. 47 (5): 440–447. 10.1159/000502840 [DOI] [PubMed] [Google Scholar]
  19. Marshall, Audrey C., Mary E. van der Velde, Wayne Tworetzky, et al. 2004. Creation of an atrial septal defect in utero for fetuses with hypoplastic left heart syndrome and intact or highly restrictive atrial septum. Circulation 110:3. 10.1161/01.CIR.0000135471.17922.17. [DOI] [PubMed] [Google Scholar]
  20. Mavroudis, Constantine D. 2011. Foetal cardiac intervention: An ethical perspective. Cardiology in the Young 21 (Supp 2): 141–147. 10.1017/S1047951111001727. [DOI] [PubMed] [Google Scholar]
  21. McCullough, Laurence B. 1998. John Gregory and the invention of professional medical ethics and the profession of medicine. Kuwer Academic Publishers. [Google Scholar]
  22. McCullough, Laurence B. 2006. John Gregory’s medical ethics and the reform of medical practice in 18th century Edinburgh. Journal of the Royal College of Physicians Edinburgh 36: 86–92. [PubMed] [Google Scholar]
  23. McCullough, Laurence B., and Frank A. Cervenak. 2018. The ethical concept of the fetus as a patient: responses to its critics. In The Fetus as a Patient: A Contested Concept and its Normative Implications, ed. Dagmar Schmitz, Angus Clarke, and Wybo Dorndorp, 40–49. Routledge. [Google Scholar]
  24. McElhinny, Doff B., Wayne Tworetsky, and James E. Locke. 2010. The current status of fetal cardiac intervention. Circulation 121:10. 10.1161/CIRCULATIONAHA.109.870246. [DOI] [PMC free article] [PubMed] [Google Scholar]
  25. Moon-Grady, Anita, Shaine A. Morris, Michael Belfort, et al. 2015. International fetal cardiac intervention registry: A worldwide collaborative descriptive and preliminary outcomes. Journal of the American College of Cardiology 66 (4): 388–399. 10.1016/j.jacc.2015.05.037. [DOI] [PubMed] [Google Scholar]
  26. Morray, B.H., S.K. Sathanandam, T. Forbes, et al. 2023. 3-year follow-up of a prospective, multicenter study of the Amplatzer Piccolo™ Occluder for transcatheter patent ductus arteriosus closure in children ≥ 700 grams. Journal of Perinatology 43: 1238–1244. 10.1038/s41372-023-01741-1. [DOI] [PMC free article] [PubMed] [Google Scholar]
  27. Nykanan, D. 2020. Ethical considerations in the transcatheter management of congenital heart disease. In Bioethical Controversies in Pediatric Cardiology and Pediatric Cardiac Surgery, 153–162. Springer- Verlag. [Google Scholar]
  28. Pickard, Sarah S., John B. Wong, Emily M. Bucholz, et al. 2020. Fetal aortic valvuloplasty for evolving left heart syndrome: a decision analysis. Circulation Quality and Outcomes 13:4. 10.1161/CIRCOUTCOMES.119.006127. [DOI] [PMC free article] [PubMed] [Google Scholar]
  29. Rebizant, Beata, A. Adam Koleśnik, A. Grzyb, et al. 2021. Fetal cardiac interventions – are they safe for mothers? Journal of Clinical Medicine 10 (4): 851. 10.3390/jcm1004085I. [DOI] [PMC free article] [PubMed] [Google Scholar]
  30. Rodriguez, Marco, Betul Yilmaz, Anita Moon-Grady, et al. 2019. Fetal cardiac intervention in aortic stenosis and aortic atresia with severe mitral regurgitation: a report by the International Fetal Cardiac Intervention Registry. Journal of the American College of Cardiology 73 (9 Supp 1): 586. 10.1016/S0735-1097(19)31194-5. [Google Scholar]
  31. Roth, Rachel. 2000. “No less than ravishment”: Forcing Medical Interventions on Pregnant Women. In Making Women Pay: The Hidden Costs of Fetal Rights, ed. Rachel Roth, 102–107. Cornell University Press. 10.7591/9781501718656-007. [Google Scholar]
  32. Saia F. 2021. Fetal balloon aortic valvuloplasty in utero at the University Hospital of Bologna, Policlinico St Orsola, by the pediatric interventional cardiology team led by Andrea Donti with @GEgidyAssenza and Elisabetta Mariucci. The newborn is now 1 month old, growing just fine. Twitter (now X), November 9, 2021. https://x.com/saia_francesco/status/1457787795754262531. Accessed 15 Jul 2024.
  33. Salice, P., N. Persico, C. Casalone, S. Natoli, and F. Lombardi. 2016. Ethical Aspects of Fetal Heart Interventions. In Fetal and Hybrid Procedures in Congenital Heart Diseases, ed. G. Butera, J. Cheatham, C. Pedra, D. Schranz, and G. Tulzer. Springer. 10.1007/978-3-319-40088-4_1.
  34. Samples, Stefani, Rupali Gandhi, Joyce Woo, and Angira Patel. 2024. Ethical Considerations in Fetal Cardiology. Journal of Cardiovascular Development and Disease 11 (6): 172. 10.3390/jcdd11060172. [DOI] [PMC free article] [PubMed] [Google Scholar]
  35. Schmitz, Dagmar, Angus Clarke, and Wybo Dondorp. 2018. The fetus as a patient: a sustainable approach for clinical interactions in the field of new prenatal medicine? In The Fetus as a Patient: A Contested Concept and its Normative Implications, ed. Dagmar Schmitz, Angus Clarke, and Wybo Dorndorp, 3–14. Routledge. [Google Scholar]
  36. Siffel, Csaba, Tiffany Riehle-Colarusso, Matthew E. Oster, and Adolfo Correa. 2015. Survival of children with hypoplastic left heart syndrome. Pediatrics 136 (4): e864–e870. 10.1542/peds.2014-1427. [DOI] [PMC free article] [PubMed] [Google Scholar]
  37. Simpson, J. M., and G. K. Sharland. 1997. Natural history and outcome of aortic stenosis diagnosed prenatally. Heart 77 (3): 205–210. 10.1136/hrt.77.3.205. [DOI] [PMC free article] [PubMed] [Google Scholar]
  38. van der Linde, Denise, Elisabeth E. M. Konings, Maarten A. Slager, et al. 2021. Birth prevalence of congenital heart disease worldwide. Journal of the American College of Cardiology 58 (21): 2241–2247. 10.1016/j.jacc.2011.08.025. [DOI] [PubMed] [Google Scholar]
  39. Wiesemann, C. 2018. Which ethics for the fetus as patient? In The Fetus as a Patient: A Contested Concept and its Normative Implications, ed. Dagmar Schmitz, Angus Clarke, and Wybo Dorndorp, 29–39. Routledge. [Google Scholar]
  40. Yilmaz, B., and S.A. Morris. 2024. Catheter-based fetal cardiac intervention. Journal of Cardiovascular Diseases 11 (6): 167. 10.3390/jcdd11060167 [DOI] [PMC free article] [PubMed] [Google Scholar]

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