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How to deliver the best: a call for action for congenital heart disease treatments in India Anita Saxena*

ABSTRACT: Most of the children born with congenital heart disease are expected to lead normal, productive lives if treated in time. However, the privilege of early diagnosis and timely intervention is restricted to children born in developed countries. India has one of the highest birth rates in the world and, considering that the prevalence of congenital heart disease does not vary in different regions, a large number of babies with congenital heart disease are born in India every year. It is estimated that approximately 80,000 newborns with heart disease need early intervention to survive their first birthday. Less than 10% of these actually undergo intervention. Providing optimal care for all these children is a daunting task, and requires funds and proper planning at various levels of the healthcare system. Currently, India only has 22 cardiac centers for children with heart diseases and only three of these are funded by the government. This article describes the magnitude of the problem, lacunae in the current state, and challenges and opportunities for providing care to this large population of children. Background The outcome for children born with congenital heart diseases (CHD) has markedly improved over the last 3–4 decades. Advances in pediatric cardiology and cardiac surgery have made it possible to repair or palliate most of the CHD, including the complex ones. Over 85% of operated cases are expected to survive to adult life. Unfortunately, access to quality care for children with CHD is restricted to certain privileged regions of the world and the majority of children born in developing countries fail to get proper treatment for their CHD, for which there are several reasons. First, the high cost of congenital cardiac intervention is not affordable for the majority of the population living in these regions. Second, most centers providing care for children with CHD are located in developed countries, whereas most children requiring cardiac care do not live in these countries. Besides the high cost of treatment, cultural stagnation and political scenarios may also act as a barrier for the treatment of children with CHD in some of the less privileged regions. It is said that CHD are difficult to prevent and expensive to treat. Furthermore, the birth rates in most developing countries, including India, are very high, resulting in a large number of children being born with CHD. Treatment of such children is a daunting task since congenital cardiac care is highly resource intensive, both in terms of trained staff, as well as equipment and infrastructure.

KEYWORDS 

• congenital heart disease • developing countries • India

Burden of the disease in India CHD are the most common form of congenital defects and are responsible for the majority of deaths due to congenital diseases. Several studies, mostly from developed countries, have reported the prevalence of CHD between four and eight per 1000 live births [1–3] . These statistics for prevalence *Department of Cardiology, All India Institute of Medical Sciences, New Delhi 110029, India; Tel.: +91 11 26594861; Fax: +91 11 26588663; [email protected]

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Perspective Saxena have been found to be generally constant across various geographic locations throughout the world [4–6] . Due to paucity of data from developing countries, it may be difficult to estimate the total burden, but the prevalence of CHD is not likely to be very different in these countries. Extrapolations of the reported prevalence can give rough estimates of the burden of CHD in India. It is expected that 150,000–200,000 children are born with CHD in India every year. Of these about a third (80,000) would need early intervention to survive the first year of life [7] . In fact, as many as 10,000 babies may be born with transposition of great arteries every year in India. These are obviously estimations and the actual problem may be far more acute. High rates of maternal infections during pregnancy may result in ahigher prevalence of CHD in children than that reported from the Western countries. Another pool of patients consists of older infants and children with less critical heart disease who have survived despite no intervention. Current status of pediatric cardiac care in India Since most children are not intervened upon, the mortality and morbidity due to CHD is likely to be very high in India. According to a publication in 2005, less than 5% of babies born with critical CHD actually undergo cardiac surgery or any other form of intervention in India [7] . However, the total number of infant open heart procedures has almost doubled over the last 5 years [8] . On average, one cardiac centre caters to a population of 120,000 in North America, compared with one center for 16 million people in Asia [9] . In most parts of India, very little or no government subsidy exists for congenital cardiac care and most families do not have health insurance. In cases where insurance is available, several insurance companies do not cover congenital lesions, so the families have to generate all the resources required for surgery or other interventions out of their own pocket or from charity, donations, loans and, at times, by selling family owned property or other similar extreme steps. The cost of most commonly performed surgical procedures for CHD exceed the annual family income of a large proportion of the Indian population. Often the parents prefer not to seek surgery, choosing to have another child rather than resort to measures to generate necessary resources. This is truer when the child is a female, or when the surgery for CHD has to

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be staged or the outcome is not expected to be favorable [10] . Another area of concern is the late presentation of these children to the referral centre. CHD often remain undiagnosed or untreated in the vast majority of children due to lack of awareness among healthcare personnel. Several of these infants succumb in the first year of life itself. Myths such as ‘surgery is not safe below a certain age and weight’ and ‘children with CHD can never lead a normal life’ are not uncommon, especially in rural areas. Late referral of children with certain CHD leads to a compromised outcome after surgery. Children with large left to right shunts often develop pulmonary vascular disease if not operated on in time. Postoperative period may be complicated by myocardial dysfunction, pulmonary hypertension and/or arrhythmias resulting in high morbidity and mortality. Similarly, delay in surgery for cyanotic heart diseases like tetralogy of Fallot is associated with poorer outcomes. In India, it is common practice to observe adults with unoperated tetralogy of Fallot presenting with severe polycythemia, coagulation abnormalities, hemoptysis due to aorto–pulmonary collaterals, brain abscess and infarcts in cardiology clinics. In infants and young children, associated comorbid conditions such as malnutrition and recurrent respiratory infections influence the outcome adversely. The total investment in health and healthcare is very low in India. Priority is given to infectious diseases such as malaria, tuberculosis and HIV/AIDS, and malnutrition for budget allocation. It is well established that treatment of CHD saves lives, cost effectively. Over 70% of all CHD are relatively simple and can be considered completely ‘cured’ with almost normal life expectancy. However, treatment of CHD is not considered a national priority and there is no national policy for children with CHD. Data has shown that mortality from infectious diseases is declining with epidemiological transition and noncommunicable diseases are becoming relatively more important. In urban areas, small families with one or two children are normal, at least in the middle class and among the affluent. Affordability for treatment is improving in this class and demand for high quality cardiac centers is gradually increasing. More than ten centers have been established over the last 10 years in India, with the majority of these facilities being private set ups in metro cities and providing high quality care at a high cost.

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A call for action for congenital heart disease treatments in India  Factors responsible for current state Some of the well known reasons for the current state of affairs that are specific to CHD are listed below. These are primarily due to poor accessibility, affordability and acceptability. ●● Enormous number of patients: as detailed above, the number of children with CHD requiring intervention is very large in India. One needs over 200 large volume centers that can cater to at least 1000 surgeries every year. This high demand makes any healthcare policy very challenging; ●● Lack of awareness about CHD. Diagnosis of CHD at birth or in infancy is often missed in India. Over 50% of birth deliveries are unsupervised and many newborns with duct dependent CHD may die before receiving appropriate medical attention. In addition, healthcare providers are also not sensitized to the problem of CHD in general, with the situation being worse in rural areas. The current medical curriculum for specialization in pediatrics provides very little exposure to cardiology. The general public is quite ignorant about CHD in children and tend to believe that it is a very rare disease; ●● Delayed referral: lack of awareness, coupled with lack of understanding of the seriousness of the disease, results in late referral of patients to cardiac centers. Late presentations are associated with markedly increased morbidity, hospital stay, cost and mortality. Complications secondary to CHD constitute a huge drain on limited resources, although this cost is not included in the original budget; ●● High cost of treatment: in over 80% of cases, the patients’ families have to pay for the cost of treatment, which includes the high cost of surgery. Government funding is available for less than 10% of cases. Some corporations fund the treatment of children of their employees; however, philanthropic organizations including nongovernmental organizations (NGOs) fund the rest of patients. The cost of follow-up visits after surgery or other interventions is invariably born by the patient’s family as no assistance is provided for this by most organizations; ●● Lack of specialized centers: pediatric cardiac care is not available in several states in India. Patients and their families from these states have to travel long distances for treatment.

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This introduces unfamiliar surroundings, at times with language barriers, further putting these patients at a disadvantage. Even if the families were able to afford treatment of CHD, the existing person power can deal with barely 10–20% of the total load. Of the centers available in metro cities, many cater to overseas patients since that generates higher revenue. Establishing new centers is very difficult and remains a big challenge, due to huge investments necessary for technology infrastructure and trained manpower; ●● Shortage of trained personnel: India has worse doctor–patient and nurse–patient ratios when compared with countries such as China and Brazil. There is a perpetual shortage of nurses, technicians and doctors, in practically all facilities. No formal training programs are available for pediatric cardiac surgeons, intensivists, anesthesiologists and nurses in India; ●● Social reasons: cardiac surgery is not easily accepted by most families even if it is offered free of cost. Families return for follow-up or intervention only when the child becomes very symptomatic and this delay adversely affects the outcome of intervention. The other social problem is parental preference for male children. This gender disparity in healthcare is widely prevalent in India, as evidenced by Ramakrishnan et al., girls were less likely to undergo cardiac surgery for CHD than boys [10] . Many parents feel that the prospect of marriage is affected adversely if the girl has a scar on her chest, which has resulted in an increase in demand for device closure of septal defects and nonsurgical options, even though devices are far more expensive than surgery, at least in government hospitals. In addition, there are several factors related to policy issues that are specific to India. These are described below: ●● Inadequate investment in health: the Indian government spends 1.4% of total government spending on health, as compared with 21.8% by the US government [11] . The differences are not so stark when comparing budget allocation for defense and education (the USA spends 4.4% of gross domestic product on defense; China: 2.0%; Russia: 4.4%; and India: 2.5%). In the developing world, even Pakistan and Myanmar spend higher proportions on health as compared with India. Of the total spending,

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Perspective Saxena cardiovascular disease is a low priority area and infectious diseases get priority. It is generally believed, even by many health professionals, that surgery for CHD is not profitable or sustainable; ●● Lack of policy/legislation: unlike most developed nations, India has no national policy for the treatment of CHD. In 2008, out of the INRs 63 billion for integrated child development schemes, no allocation was made for CHD [12] . In a publication from the World Bank, no one model for healthcare delivery was found to be the best for low income countries, and the success and failure of such health systems was closely linked with the country’s political, societal, cultural and geographical variables [13] . This further proves that progress in the care of children with CHD cannot be dissociated from general progress of a nation indicated by economic growth and other human development indices. High cost of CHD treatment is not the only factor for the current state of affairs. A recent policy providing free care to pregnant mothers and newborns (up to age 30 days) in predesignated hospitals has been introduced. This may cover some of the newborns with critical heart disease; even though most hospitals providing this free service do not possess quality care facilities for CHD; ●● Chaotic healthcare system: focus on primary healthcare is very important for successful health delivery. The public health systems in India are largely dysfunctional. The private sector is completely unregulated and out of bounds for most of India’s population. Large numbers of centers are clustered in metro cities and many of these cater predominantly to overseas patients. Strategies for delivering the best to the least affording populations of India Delivering the best care for children with CHD is an ardent task and needs careful planning since resources are markedly limited. However, these limited resources are very often improperly utilized. Some of the strategies suggested below have been tested successfully in other developing countries such as Brazil and China, and have potential positive applications in India: ●● Reduce the burden of CHD: prevention of

CHD may be difficult as the etiology is multi­ factorial and often remains unrecognized. The

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control of very high birth rates in India by proper family planning has the potential to reduce the total burden of CHD. Good antenatal care for pregnant mothers (that includes adequate nutrition, routine immunization, and avoidance of infections such as Rubella and teratogens during gestation) is also likely to help. Maternal malnutrition can predispose mothers to infections during pregnancy and thereby increase the likelihood of CHD, and research into local and risk factors should be part of the agenda for improving pediatric cardiac care. In general, smaller numbers of children per family translates into better health of the children. The Government of India is encouraging small families and incentives are being allocated to families with a single girl child. However, there is no national policy on birth control; ●● Establishing more centers: opening up new

centers that are capable of providing good quality care for patients with CHD is difficult, but is the most sustainable approach over the long-term. Pediatric cardiac care requires sophisticated infrastructure, and new centers should be regionally distributed such that patients and their families do not have to travel long distances. Establishing new centers requires funding, personnel with leadership qualities, and trained and motivated staff, with funding potentially provided either by the state or central government, or by the private sector. To date, India has 22 centers, ten of these have been established in last 10 years. There are only three centers funded by the government and no new government aided centre has been opened in the last 10 years. It is important to note that most of the new centers have been set up in the southern half of India, with little or no facilities in some of the most populous and poor states of other regions of India such as Uttar Pradesh, Bihar and Orissa. There is an urgent need to establish good quality pediatric cardiac care centers in these states. In contrast, a large number of centers catering to adults with heart disease have been established all across India. The government must provide incentives for employing staff in new centers to attract experienced health personnel. Returning citizens trained in developed countries are providing help in establishing new centers of high standards;

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A call for action for congenital heart disease treatments in India  ●● Availability of trained staff: establishing a pedi-

atric cardiac centre requires trained and dedicated staff. In India, there are currently no structured training programs for cardiac surgeons, intensivists and anesthesiologists. For cardiology training, a 2-year training program has been initiated by the National Board of Examination; however, the training leaves much to be desired. Most specialists provide pediatric practice out of their interest in the subspecialty even though they have not been trained formally in pediatric cardiac care. Some of these specialists have been trained in Western countries for a couple of years before taking up these practices in India. We urgently need formal, structured medical training programs within India. Considering the high volume of patients and procedures that most centers have, this should not be a difficult proposition. Medical bodies such as the Medical Council of India and the National Board of Examination have to be engaged for initiating these programs and fellowships; ●● Make treatment more affordable and accessible: cost of treatment of CHD is unaffordably high for the average Indian family. The cost not only includes hospital charges, but also the cost of travel and accomodation, as well as the cost of workdays lost and more. Hospital charges can be exuberant in private centers and the bill keeps expanding if the postoperative stay becomes longer for any reason. The cost of treatment may be much less in government run hospitals, but the family has to stay longer due to long waiting lists that are common in these hospitals. The government runs several programs for poor patients, defined as those living below the poverty line; such families are given special identification cards (BPL or below poverty line cards) and they can avail several facilities free of cost, including healthcare in government hospitals. Several states in India have similar programs, for example Andhra Pradesh and Tamil Nadu have special programs for free congenital heart surgery for all children whose families cannot afford treatment. Some hospitals have different tiers for payment depending on the family income. Several regional charity organizations have established pediatric cardiac care facilities helping these children. The state of Karnataka has introduced a microfinance scheme for poor families, where a small amount of money is

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given as insurance premium on a monthly basis and in return all treatment is free. Details of these schemes can be seen in the publication by Maheshwari and Kiran [14] . Several states run free school health programs and if a cardiac disease is detected, it is treated free of charge. A nationwide scheme was launched for pregnant mothers and newborns up to the age of 30 days. As mentioned previously, another source of funding, available to some families, is from their employers (government and private), the assistance may be partial or total. Most of these assistance programs are limited to hospital costs and the patient’s family has to provide the money for transport to the hospital, stay, food and follow-up visits; ●● Resource generation: this is a difficult task as the resources in India are already limited. Some mechanisms to encourage risk sharing will go a long way in resource generation. Several NGOs, religious bodies and other philanthropic organizations are supporting pediatric cardiac programs by offering to pay the cost of treatment for surgeries, in part or full, and by procuring and donating equipment and medicines. Funds for establishing new centers are hard to come by and it may be better to approach government or philanthropic organizations for this. Funds for expanding an existing program, which has proven itself with a reasonable outcome, are easier to obtain but will depend heavily on the resourcefulness of the leader of the program. For example, the addition of pediatric heart program to an already successful adult cardiac program is a lot easier than starting a fresh pediatric cardiac program. Hence many centers piggy back a pediatric program on to the existing adult cardiac program, sharing their facilities, personnel and funds. The pediatric program can then gradually be expanded to treat neonates and children with more dedicated staff and equipment. Many such units may ultimately evolve into a self-sustaining program with its own staff, protocols and training programs. The advantages of this model include a larger pool of fellows, residents and support staff that can be shared between adult and pediatric services, thereby reducing the overall cost. Potentially profits made from the adult program can be partially siphoned towards pediatric cardiac care, which by itself may be less sustainable. Such models have been successfully employed

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Perspective Saxena in all three government run programs to date. However, such a model is not without problems. Often adult care takes precedence over pediatric care and it is difficult to develop a neonatal cardiac surgical facility in this setting, as this requires more sophisticated support, dedicated manpower, expertise and technology; ●● Optimal utilization of resources: once established, sustaining a successful pediatric cardiac program is the next challenge. All efforts must be made to keep the program running, keeping the cost low, without affecting the results. Containment of cost encompasses a number of measures; some of these are listed below: ●● Cost-effective strategies: timely intervention in a given case is necessary for optimal outcome, it also reduces the duration of preand post-operative stay in the hospital, mandating trained staff at primary care level. Diagnostic cardiac catheterization can be replaced by low cost detailed echocardiography in most instances. Reusing hardware for catheterization after proper sterilization has been a usual practice in most centers in India and no deleterious effects have been observed with this practice. Other measures that will reduce the cost of care in intensive care units include fast tracking with early extubation. This will also minimize the use of expensive laboratory facilities. Direct import of materials required for catheterization and surgery from principals should be encouraged as that would remove the cost of the intermediaries like local agents, making it cheaper; ●● Indigenization and innovation: most disposable materials are imported from Western countries at a very high cost; use of high quality indigenous products manufactured locally must be encouraged. Some of these can be obtained at less than 10% of the cost of the imported item. Brazil has taken a lead in this direction, with most of the material manufactured locally. Some products are also being manufactured in India, such as Chitra heart valve, pacemakers, stents and oxygenators, however a lot more needs to be done. For achieving indigenization, development of the medical industry must be encouraged; ●● Careful case selection: utilizing limited resources for patients who are most likely to

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benefit and lead a relatively event-­free survival may be a consideration in overburdened countries like India; however, this is an ethical dilemma that has no easy answers. These decisions are best left to the family, counseling them about the need for multistage surgery in case of some complex CHD including univentricular hearts. Most parents choose compassionate care for their newborns with very complex CHD-like hypoplastic heart syndrome. Fortunately, more than 75% of CHD are simple and amenable to intervention with good long-term outcomes; ●● Developing local protocols and safety culture: guidelines published for developed countries are unlikely to be relevant for developing countries, so local cost-effective protocols and checklists must be developed. These need to be evidence based and/or by consensus of experts. Once formulated, these guidelines must be widely circulated and publicized for the benefit of the practitioners. However, it is important to bear in mind that the patient’s safety is paramount and should never be compromised at any cost; ●● Developing high quality nursing: this is often a neglected area and is the missing link in the care of children with heart disease. No structured training programs have been developed for nurses caring for newborns and infants who often require very intense nursing care. Fortunately, there has been some progress over the last decade on this front, with help from Western centers. Periodic webinars are held for nurses covering important areas such as infection control, as well as fluid and electrolyte regulation in the intensive care unit. ●● Periodic auditing of services: for any program, evaluating its performance is a must, even if it has apparently excellent results. Auditing helps in outcome assessment and quality improvement. It paves the way for further modifications where care for CHD can be undertaken at a lower cost and with limited resources. It is generally seen that as the volume of cases increases in a centre, the results further improve and better infrastructure can be developed over time; ●● Improve awareness about CHD: pediatricians and other primary care givers have to be

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A call for action for congenital heart disease treatments in India  sensitized to the diagnosis of CHD through continuing medical education programs. The perception that nothing can be done for these children has to be countered by outcome data. The formation of national groups aiming at increasing awareness regarding CHD is a step taken in right direction. Protocols for the timing of intervention for CHD have been widely published in pediatric and cardiology journals to help practicing paediatricians. Screening newborns with pulse oximetry has demonstrated promising results in the UK and USA. How much difference would it make in India remains to be seen, as over 50% of babies are born at home, potentially unsupervised. Awareness generation in the community through print and widely available electronic media should also be on the national agenda; ●● Changes in healthcare delivery: this is a very difficult but necessary step to improve care of children with heart disease. Health care delivery has to be tailored to patients’ needs, which may include special protection beyond medical care. Increased investment in health, especially for children, is the need of the hour in India. Policy makers have to be convinced by the pediatric cardiac community and for this we need to generate data to deomstrate the burden of CHD and the outcome data for those intervened in time. It is time that some of the higher volume centers come together to pool their data so that this task can be taken up with the policy makers. Conclusion Most children born with congenital heart disease in India do not have access to quality care. It is well established that treatment of CHD is cost effective and this justifies the

Perspective

concept of pediatric cardiac care. However, a number of challenges/barriers need to be overcome before an average child born in India has access to comprehensive cardiac care. Over the last decade or so, some of these challenges have been addressed. Several new centers have been established, trained manpower is increasing, and newer cost-effective strategies and innovations are being developed. As the burden of these patients is huge, a lot more needs to be done before a real impact on outcome becomes obvious for children born with CHD. Future perspective The majority of children with heart diseases are born in developing countries where treatment facilities are either sparse or nonexistent, leading to high morbidity and mortality. Over 85% of these children would lead a normal, productive life if timely intervention was available to them. India has a high burden of this problem and the resources are not only limited, but improperly utilized. The challenges of providing optimal care for an average child with heart disease are unparalleled, and will lead to innovations and opportunities. In addition, a collective effort by government, NGOs, physicians and other care givers will be required for continued improvement in healthcare delivery. Financial & competing interests disclosure The author has no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties. No writing assistance was utilized in the production of this manuscript.

EXECUTIVE SUMMARY ●●

A large number of children are born with congenital heart disease in India.

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A small proportion of those requiring it undergo intervention.

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Lack of awareness among physicians and other care givers leads to delayed referral, and high morbidity and mortality.

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The whole of India has only 22 specialized centers for these children, the majority of which are privately funded where the treatment is expensive and unaffordable for the majority.

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The healthcare systems are chaotic and there are no policies or legislation for congenital heart diseases in India.

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Delivery of effective care to an average child will entail research, advocacy and innovations, keeping in mind limited resources and infrastructure.

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Perspective Saxena disease: comprehensive observations over a 24 year period in a defined region of Canada. Can. J. Cardiol. 10, 821–826 (1994).

References Papers of special note have been highlighted as: • of interest; •• of considerable interest 1

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Hoffman JIE, Christianson R. Congenital heart disease in a cohort of 19,502 births with long term follow-up. Am. J. Cardiol. 42, 641–647 (1978).

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Saxena A. Congenital heart disease in India: a status report. Ind. J. Ped. 72, 595–598 (2005).



Fyler DC. Report of the New England Regional Infant Cardiac Program. Pediatrics 65(Suppl.), 375–461 (1980).

Describes the state of pediatric cardiac care in India.

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Abdulla R. What is the prevalence of congenital heart disease? Pediatr. Cardiol. 18, 268 (1997).

Kumar RK. The nuts and bolts of pediatric cardiac care for the economically challenged. Ann. Pediatr. Cardiol. 2, 99–101 (2009).

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Carlgren LE. The incidence of congenital heart disease in children born in Gothenburg 1941–1950. Br. Heart J. 18, 40–50 (1959).

Pezzella T. Worldwide maldistribution of access to cardiac surgery. Letter to the Editor. J. Thorac. Cardiovasc. Surg. 123, 1016 (2002).

10 Ramakrishnan S, Khera R, Jain S et al.

Dickinson DF, Arnold R, Wilkinson JL. Congenital heart disease among 160,480 liveborn children in Liverpool 1960–1969. Br. Heart J. 46, 55–62 (1981). Roy DL, McIntyre I, Human DG et al. Trends in the prevalence of congenital heart

Gender differences in the utilisation of surgery for congenital heart disease in India. Heart 97, 1920–1925 (2011). •

Highlights the treatment utilization by two genders. Girls were clearly at a disadvantage as compared with boys when the delivery of treatment was considered.

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11 World Health Organization. World Health

Statistics 2005. WHO Health Statistical Information System (2005). World Health Organization,  Geneva, Switzerland (2005). 12 Lahariya C. Budget India 2008. What is new

for health sector. Indian Pediatr. 45, 399–400 (2008). 13 The World Bank. Good practices in health

financing. In: Lessons From Low and Middle Income Countries. Gottret P, Schieber GJ, Waters HR (Eds). The World Bank, Washington, DC, USA, 57–76 (2008). 14 Maheshwari S, Kiran VS. Cardiac care for the

economically challenged: what are the options? Ann. Pediatr. Cardiol. 2, 91–94 (2009). •• Provides information about the available options for funding in different states in India. The information is very useful for care givers dealing with the economically disadvantaged population of India.

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How to deliver the best: a call for action for congenital heart disease treatments in India.

Most of the children born with congenital heart disease are expected to lead normal, productive lives if treated in time. However, the privilege of ea...
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