It is estimated that there are around 50 tertiary pediatric cardiac centers in India which are staffed with trained pediatric cardiologists, pediatric cardiac surgeons, anesthetists, and intensivists. Most of these centers are concentrated in urban metropolitan areas. There is also a regional discrepancy in the density of advanced pediatric cardiac centers, with much fewer such institutions in north, central, and eastern India, while major cities in south and west have multiple centers offering high-quality pediatric cardiac care located within a few kilometers of each other.
Nonetheless, outside of such tertiary pediatric cardiac facilities, congenital cardiac interventions and surgeries are being done at multiple smaller hospitals and catheterization labs, even in tier-2 and tier-3 cities. The reason for this is two-fold. First, indigent rural parents are often hesitant to travel large distances to seek treatment for their child’s congenital heart defect. Traveling to a faraway metropolitan city is often an intimidating prospect for them. Furthermore, daily wage earners fear loss of income for the duration of their child’s hospital admission. Second, with close to 300 trained pediatric cardiologists in India currently, at various stages of their careers and with different levels of experience, many have chosen to establish their practices in smaller cities and towns. These factors have prompted some pediatric cardiologists to travel to smaller cities or towns well away from their regular institution for outreach clinics, procedures, and interventional camps. In addition to pediatric cardiologists, adult cardiologists also perform congenital cardiac interventions. Consequently, it is not uncommon to find pediatric cardiac interventions being performed at smaller centers, sometimes with suboptimal infrastructure and no cardiac-surgical backup.
In this editorial, we put forth our point of view regarding what should be the minimum requirements for performing pediatric cardiac interventions in the Indian scenario.
PEDIATRIC CARDIAC INTERVENTIONS – BARE ESSENTIALS TO IDEAL
In India, with the exception of few high-volume dedicated pediatric cardiac centers, most centers share cath-lab infrastructure with adult cardiology teams. The experience and expertise of operators, anesthetists and technicians, and nurses in handling neonates and children varies widely. A defibrillator with small-sized paddles, an oximeter to estimate oxygen saturation, and a ventilator with neonatal and pediatric settings are bare essentials for any operator or center performing pediatric cardiac interventions. Table 1 summarizes the various essential and ideal hardware required to perform pediatric cardiac interventions in the Indian scenario..
CATH-LAB INTERVENTIONS: NECESSITY VERSUS CONVENIENCE
Balloon atrial septostomy (BAS) is sometimes required as an emergency, life-saving procedure and can be done with only echocardiographic guidance. BAS improves saturation of neonates with transposition of great arteries with the intact septum and helps stabilize the baby before transfer to a tertiary cardiac center for the arterial switch operation. There may be no controversy when such life-saving interventions are performed in peripheral setups without proper surgical backup. A similar argument can be made for emergency balloon aortic or pulmonary valvotomy in critical aortic and pulmonary stenosis, respectively. Even though percutaneous transvenous mitral commissurotomy in children is a difficult procedure, it may be considered in a lesser equipped center in dire emergencies in the absence of surgical backup.
Balloon pulmonary valvuloplasty may be performed in peripheral setups, especially if the pediatric cardiologist or a trained cardiologist confident of performing the procedure safely is available onsite.
Most device closures, however, are elective procedures. In an ideal scenario, device closures should be done by trained pediatric cardiologists with available onsite surgical backup. The argument for doing device closures at tertiary centers is the available expertise of the staff, the available hardware on shelf and, of course, the surgical backup. In experienced hands, device embolization is rare, perhaps with an incidence <1%. A good echocardiogram immediately before device release can help detect suboptimal device position and reduce chances of embolization. Furthermore, with experienced operators, the chances of successful retrieval of an embolized device are high. However, for safe and successful device retrieval, the correct hardware is essential. Appropriate gooseneck snares and bioptomes should be essential hardware prerequisites for attempting any device closure in the absence of surgical backup. As these are “nonmoving items” as per the hospital inventory personnel, a nonmedical administrative staff may decide to discard or not replace these hardware, as these might only be required once in a few years. However, the interventional pediatric cardiologist must ensure that such device retrieval hardware is available on the shelf in every cath-lab where he or she is performing procedures.
In the rare instance of the device dislodging to a location from where transcatheter retrieval is unsafe, such as an embolized ventricular septal defect (VSD) device entangled in mitral chordae, or even a device at its desired location causing an undesired complication, such as a VSD device in a perimembranous VSD causing severe tricuspid regurgitation or new-onset complete heart block, it is extremely helpful and reassuring to have the option of referring the patient to the pediatric cardiac surgeon in the same hospital for surgical retrieval. Catastrophic procedural complications such as a tear in the right atrial wall or right ventricular outflow tract (RVOT), or aortic dissection or rupture, can only be salvaged with immediate surgery, which would logistically require a surgeon, perfusion team, and operation theater on physical standby while the cath-lab intervention is being done. Fortunately, such complications are extremely rare, and adequate planning, experienced operators, and gentle wire and catheter manipulation can help prevent them.
Stenting in children
Neonatal palliative interventions such as ductal and RVOT stenting are high-risk procedures and require a great deal of precision and proper hardware. Sometimes, even in experienced hands, complications can occur. Performing these procedures at peripheral centers without proper pediatric cardiac surgical backup is perhaps not justified, especially when there is a safe and predictable option of starting Prostaglandin E1 infusion and transferring the baby to a dedicated pediatric cardiac center. The same argument applies to patent ductus arteriosus device closure in preterm neonates and pulmonary valve perforations.
In some Indian centers, adult interventionists often perform coarctation stenting in children and adolescents. However, proper training, availability of covered stents and surgical backup is desirable for such elective procedures associated with rare, unpredictable, but potentially catastrophic complications.
PROCTORSHIP PROGRAMS FOR COMPLEX INTERVENTIONS
The training of an interventional pediatric cardiologist in India begins with the pediatric cardiac superspecialist training (Fellowship in National Board, Doctor of Medicine and Diplomate in National Board) and then continues through their initial years as a senior registrar, junior consultant, and independent consultant. After gaining sufficient experience with simple interventions, the operator gains confidence in performing more complex interventions such as VSD device closures, ruptured sinus of Valsalva device closures, coarctation stenting and gradually progresses to perform neonatal ductal and RVOT stenting. However, for every complex intervention, there is a learning curve, which may be longer in the absence of a more experienced operator to mentor the interventionalist in their early years of practice. Percutaneous pulmonary valve implantation, sinus venosus atrial septal defect transcatheter closure and device closure of paravalvular leaks are more complex interventions. Competency in these procedures can be achieved effectively with a proctorship program, where a trained proctor guides and supervises the initial few procedures on-site, to help the interventional pediatric cardiologist gain confidence to perform subsequent procedures independently. It goes without saying that these procedures should only be performed at tertiary cardiac centers with surgical backup.
PEDIATRIC CARDIAC INTERVENTIONS IN INDIA – IT IS NOT REASONABLE TO BE SUBOPTIMAL!
In a perfect world, we should not be accepting lower standards, and the Indian scenario should not be considered different from the ideal scenario. However, only 50 institutions cannot handle the pediatric cardiology interventional needs of the entire country, with nearly 64,000 children born every day in India. However, “who does what procedure, and in which setup it is done” is often decided by the individual interventionist. This is not acceptable. There is no system of regulation and accreditation in India. We must evolve a system of accrediting the physician, hospital, and healthcare system for the various pediatric cardiac interventions. We need to define the minimum number of procedures done as the primary operator for such accreditation. Off-label indications like perimembranous VSD device closure should be restricted to only established centers.
A consistent and a good procedural outcome is the only parameter of success. Attention to ethical aspects and a proper informed consent are paramount if an elective procedure is performed in a less-than-ideal setup. We must communicate with the family the alternative options of therapy, alternative places such therapy is available, details of the procedure, possible complications of the procedure, and teams’ ability to perform such procedures and the ability to the bailout of complications. This will help in reducing unnecessary litigations. We believe that each pediatric cardiologist may not become an expert in all types of interventions. Hence, every physician must critically evaluate the teams’ ability to perform an index procedure and they must introspect if any complications develop to ensure better results next time. All the operators should strictly follow the fundamental principle of medicine viz “primum nonnocere” (Do no harm) and proceed only after proper counseling of the patient and the family. In each and every decision, the patient’s outcome must be the overriding factor.
With increasing experience and successes, it is easy for an interventional pediatric cardiologist to get swayed toward taking on greater risks and pushing the limits of their institutional and logistic safety net. However, we must always be prepared for complications and adverse events. An effective and safe procedure should be our ultimate goal for every structural intervention, and any decision to compromise on the “ideal” scenario with a surgical backup should only be made after an unbiased and objective assessment of the pros of cons of transfer to a tertiary center versus point of care interventions.
“In the Indian scenario, it is NOT reasonable to be suboptimal.”
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