In response to - “Ethical dilemmas in pediatric cardiac interventions: Primum non nocere”

Dear Editor, In the editorial titled “Ethical dilemmas in pediatric cardiac interventions: Primum non nocere,” the authors reflect on the expanding use of catheter-based therapies for various congenital heart diseases. While a successful, unconventional life-saving intervention is usually well acknowledged, any new elective intervention is often met with skepticism and becomes a matter of debate. The authors, in the second section of the editorial, use the argument of established surgical options to drive home this point. The basis of this justification may not be entirely true if one were to go through the history of cardiac surgery and its share of several failings over the past decades before what’s considered the gold standard today. In a previous issue of the Annals, Marathe and Talwar described the evolution of the atrial and arterial switch surgeries for transposition of great arteries (TGA).[1] The Baffes operation, which began in 1956, remained the option for close to a decade despite a dismal 5-year survival rate of 29%. When Jatene conceptualized and performed the arterial switch, five successive babies succumbed, paving the way for refinement in coronary transfer techniques. The arterial switch would not have been the standard practice today if efforts at complete correction were not relentlessly pursued in thought and execution. In contrast to a newer surgical technique, a transcatheter alternative to an established surgical treatment can only be pursued if it does not endanger the patient’s life, setting higher standards for interventionists who decide to embark on a revolutionary approach. While the patient’s interests should always be at the forefront, we need to acknowledge that any new intervention comes with a learning curve before a nearly flawless execution becomes possible. This also fosters innovation in device design or different approaches to minimize complications. The stitch technique or addition of anchoring pins to prevent stent migration while closing sinus venosus defects and the Alterra system for ensuring better stability of transcatheter pulmonary valves (TPVR) are a few examples.[2,3] The editor cites an example of a device erosion managed by using another device to seal the rent. Most would agree that managing a device-related complication should address the root of the problem rather than trying to fix the complication alone. Similar principles should probably guide conditions with associations or causal pathophysiological mechanisms. Device closure of a ruptured sinus of Valsalva, leaving the subpulmonic defect unattended, doesn’t seem like the right approach.[4] In another citation, the use of 4–6 duct occluders caused aortic obstruction in three infants weighing < 5 kg. The authors point to extraneous factors like government referral systems influencing procedural timing, which are against patient interests. A similar argument exists for different corporate hospitals in a city vying for the limited patient pool and calls for serious introspection on the part of caregivers regarding optimal timing to ensure safer outcomes. Public and teaching hospitals with limited resources and larger patient loads might not be able to achieve the low morbidity and mortality rates of some corporate hospitals in the country. To ensure better outcomes, certain interventions such as balloon angioplasty for neonatal coarctations, ductal stenting for late presenters of TGA, or right ventricular outflow tract stenting as initial palliation for tetralogy of Fallot might be over-represented in such institutions, including ours. Such center-specific practices based on in-house morbidity and mortality data will have to be respected instead of being decried as nonguideline-based. If cardiac injury can be avoided, redo sternotomies are not a risk factor for postoperative morbidity or mortality.[5] This holds true for the vast majority of TPVR. Attempts to place them in dilated outflow tracts using multiple anchoring stents in normal pulmonary arteries have not been favored by most operators.[6] Considering the significant costs involved with TPVR and a potential high likelihood of emergent cardiac surgery, it is hard to justify such attempts. Ironically, redo sternotomy risks are relegated to the background when faced with valve embolization. Likewise, the ability to pay for a procedure should not influence our decision if the transcatheter option is more likely to fail. The argument for the placement of multiple devices to close a defect easily amenable to surgical correction seems untenable for similar reasons. Any transcatheter approach should rival an established surgical technique, and it seems logical to presume that patients with unfavorable pre-Fontan hemodynamics should receive the best possible hemodynamic circuit (extracardiac conduit). On the contrary, transcatheter Fontan completions in our country seem to be promoted as an alternative in high-risk Fontan subsets. They would need long-term follow-up as they don’t mimic the extracardiac Fontan, rather splinting the atrium all the way from the inferior vena cava to the atrial roof and pulmonary artery.[7] There are unanswered questions regarding atrial volumes, atrial relaxation properties or achievement of an optimal offset, crucial to maintaining the fragile cardiac output in these patients, and the risk of sinus node injury from attempts at blind perforation of the atrial roof. However, long-term results of any procedure would not be known unless one embarked on it. Long-term validation needs to be internal and external, with consistent follow-up and honest reporting of data and complications. An operator being able to replicate good results of a novel procedure at another center, or multiple operators from different centers reporting similar outcomes, would externally validate a procedure. Training programs within our country should inculcate reporting of complications at the residents’ level, instead of downplaying an event. Nightmare sessions in national conferences mostly focus on the successful management of complications. Instead, “flaw” sessions with deliberations on serious morbidity and mortality data would lead to greater transparency, paving the way for improved procedural techniques and catheterization laboratory outcomes. The editorial also stresses the importance of a combined cardiac team meeting in decision-making. The final decision following such interactions may not be totally objective, often being dictated by the surgeon or interventionist making a stronger argument for a procedure. Parents often ask if heart holes in their children can be treated with medication. However much we may argue that cardiopulmonary bypass is safe in the current era, it is quite natural for parents to choose a less invasive approach if it can offer reasonably good results. For older children and adults, it is also about getting back to education and work earlier. Rare complications such as heart blocks or aortic cusp injury arising from device closure of ventricular septal defects cannot be used to deny such procedures, when feasible.[8] This would be akin to a negative emphasis bias. Quicker recovery and higher bed turnover would allow many more patients to receive treatment in resource-limited countries. Shared decision-making with the patient calls for unbiased counseling. We must refrain from enforcing our views on the perceived superiority of a transcatheter intervention and avoid exaggerating surgical complications. To quote from Francesco Tona’s widely circulated article – ”Technology must serve medicine, not define it. We must reteach the value of uncertainty, the discipline of restraint, and the centrality of the patient.” Let these be our guiding principles while attempting new interventions. However, let’s not repudiate every novel idea or transcatheter technique and risk stalling progress. Financial support and sponsorship Nil. Conflicts of interest There are no conflicts of interest.