Dear Sir, I read with great interest and appreciation the editorial “Ethical dilemmas in pediatric cardiac interventions: Primum non nocere” by Sen and Ramakrishnan.1 Such a balanced opinion from two eminent pediatric cardiologists was a heartening experience for a surgeon. I also congratulate the authors who reported important device-related complications in that issue of the journal. As a pediatric cardiac surgeon, I commend the authors for articulating, with clarity and balance, the ethical crossroads increasingly encountered in contemporary pediatric cardiac care. Essentially, to borrow the famous quote, “just because a thing can be done does not mean it should be done.” From a surgical standpoint, the rapid expansion of transcatheter techniques has undoubtedly transformed outcomes for many children. However, the editorial rightly reminds us that technical feasibility should not be conflated with ethical justification. Surgical repair for many congenital cardiac lesions today offers predictable, reproducible, and durable outcomes with low mortality and morbidity, even in neonates and infants. When such outcomes are achievable, exposing a child to off-label or marginally indicated interventions with uncertain long-term consequences raises legitimate ethical concerns. The discussion of delayed and late complications after device closure resonates deeply with surgeons, who often manage the downstream consequences of earlier interventions. Device erosion, vascular obstruction, pseudoaneurysm formation, and valve injury – sometimes presenting years later – can convert an otherwise straightforward surgical repair into a complex, high-risk reoperation. These realities underscore the importance of long-term thinking in children, whose life expectancy spans decades. I would like to offer a word of caution regarding the two upcoming interventions, which have largely been in the surgical domain for years and have consistently yielded good outcomes: Sinus venosus atrial septal defect (ASD) and Fontan completion. Transcatheter sinus venosus ASD closure by stenting the superior vena cava (SVC) with a covered stent was a great innovation with encouraging results from India.2 It even found its way to American College of Cardiology/American Heart Association recommendations which stated, “for patients who wish to avoid surgery, procedural success is typically >95% in eligible transcatheter cases, with no deaths, and a low incidence of complications, suggesting that a transcatheter approach may be reasonable.”3 It is noteworthy that the recommendations clearly state that the surgical option should be discussed with the patient when such therapy is offered in suitable cases. This comes with the background that surgical therapy for sinus venosus ASD has been in place for years, with almost nonexistent mortality and morbidity. While this is a positive development for the adult population, the problem I anticipate arises when the therapy is extended to growing children. With growth, straightjacketing the SVC with a stent does not seem very physiological. Drawing parallels from adult cardiology, the expansion of transcatheter aortic valve replacement (TAVR) into low-risk populations has been accompanied by ongoing controversy. Consequently, surgical aortic valve replacement following prior TAVR has emerged as one of the fastest-growing adult cardiac surgical procedures in the United States, with substantial early risk; published 30-day mortality rates range from 9.3% to 15.5%.4 The lessons we are learning from there should make us wiser; when we start extending transcatheter therapy for sinus venosus ASDs in children of growing age, which is the most common time they present. Following the advent and widespread adoption of extracardiac Fontan completion in the early 1990s, surgical outcomes became more standardized, with consistently improved results and robust long-term data. In an effort to avoid redo surgery – an accepted and often unavoidable aspect of congenital cardiac care – the concept of transcatheter Fontan completion, with preparatory steps undertaken at the time of the bidirectional Glenn shunt, subsequently emerged.5 This was followed by the development of transcatheter Fontan completion without prior surgical preparation, using a novel technique that involves perforation of the atrial mass and deployment of a covered stent from the inferior vena cava to the pulmonary arteries, with or without a prefabricated fenestration.5 This approach was initially conceived for high-risk Fontan candidates, and early proof-of-concept studies – including encouraging preliminary reports from a limited number of centers in India – demonstrated technical feasibility and short-term success. However, a growing concern is the extension of this strategy to unselected, “all-comer” Fontan candidates in the absence of adequate early, mid-term, and – most importantly – long-term outcome data. Given that approximately 10% of Fontan patients, even in low-risk cohorts, eventually experience Fontan failure due to the inherent limitations of a nonpulsatile circulation, progression to heart transplantation remains a foreseeable outcome for a subset of patients. It is therefore reasonable to anticipate that prior transcatheter Fontan interventions may render future transplantation technically challenging, if not prohibitive, raising important concerns about long-term surgical salvage options. Equally important is the emphasis on a genuine heart-team approach. In many centers, decisions are still made in silos, influenced by operator comfort, institutional bias, or external pressures. A balanced forum where surgeons, cardiologists, intensivists, and imaging specialists contribute equally is essential to ensure that innovation does not outpace prudence. Shared decision-making with families must include transparent discussion of uncertainty, long-term surveillance, and alternative surgical options. Often, such procedures take place without the family meeting the surgeon. The principle of primum non nocere acquires special significance in pediatric cardiac care, where the margin for error is small and the consequences lifelong. Innovation is vital, but it must be anchored in ethics, evidence, and collective responsibility. As surgeons, we strongly support progress – but not at the cost of compromising predictable safety and durability when established surgical solutions exist. A recent report from an adult TAVR with a coronary complication describes another novel Ventriculo-coronary transcatheter outward navigation and re-entry procedure of percutaneous coronary bypass as a bailout.6 Again, the surgical minds are apprehensive about this approach, which could become a standard procedure without the checks and balances. At the risk of being a devil’s advocate, let us be aware of the saying and absolve ourselves from situations best described as “with a hammer in the hand, the whole world looks like a nail.” This editorial is a timely and necessary call for introspection, collaboration, and patient-centric decision-making, particularly in low- and middle-income countries where the cost of device-based therapies often exceeds that of surgical counterparts. I congratulate the authors on stimulating this important conversation and hope it leads to more structured, transparent, and ethically grounded care for our children. Let us remember Robert Hutchison’s famous lines and introspect: “From inability to let well alone, from too much zeal for the new and contempt for what is old, from putting knowledge before wisdom, science before art and cleverness before common sense, from treating patients as cases and from making the cure of the disease more grievous than the endurance of the same, good Lord deliver us.” Sir Robert Hutchison (1871–1960). Financial support and sponsorship Nil. Conflicts of interest There are no conflicts of interest.
Debasis Das (Thu,) studied this question.