Heart transplantation in India—looking back as we celebrate 25 years of the transplant law

Abstract

India’s heart transplantation programme is the number one programme in South Asia with an average heart transplantation rate of 0.2 per million population (pmp) versus the global average of 1.06 pmp (2016-2018). The deceased donation rate was 0.67 pmp in India in 2018. The law which made it possible has completed 25 years. In the first 5 years, after the law was passed, less than 50 hearts had been transplanted. The foundation for the deceased donation programme was laid through the creation of an ‘Organ Sharing Network’ in the year 2000 by Multi Organ Harvesting Aid Network (MOHAN) Foundation, a non-governmental organisation in Chennai. The role of the Health Department of Tamil Nadu in streamlining the deceased donation process in 2008–2009 changed the course of the programme. The heart transplantation programme evolved due to a handful of committed hospitals from the private sector. The challenge was in the identification and certification of brain death, and this continues to be the main reason for the low donation rate. The referral government hospitals, which usually receive traumatic head injuries that result in brain death, seldom possess the infrastructure or financial autonomy to start a transplant programme. Hence, expensive transplants like heart and liver have catered to the needs of the economically affordable class mostly. To improve the donation rate will require innovative thinking by taking steps such as strengthening the national programme and creating cross-subsidy formulas in organ sharing so that the less affordable too have access to such surgeries. To showcase the success of the programme, it is also imperative to start a heart transplant outcome registry to study the short- and long-term outcomes.

Introduction

On 8 July 1994, the Indian parliament passed the law called the Transplantation of Human Organs Act (THOA) that made deceased donor organ transplantation a reality in the country by accepting brain-stem death as a form of death. The first big media news, within a month after the law was passed, was the heart transplant that was conducted by Dr. P. Venugopal at the All India Institute of Medical Sciences (AIIMS), New Delhi [1]. This was followed by Dr. K.M. Cherian who performed a heart transplant in 1995 at the Madras Medical Mission Hospital, Chennai. He also did the first paediatric and first heart-lung transplantation in India [2]. It is now 25 years since the law has been passed, and it is time to look back at both the challenges in the evolution and growth of heart transplantation in India and envisage what does the future entail for this programme.

Organ transplantation from a deceased donor is a life-saving surgical procedure for failed organs such as the heart, lung or liver and has been available for the past 50 years. The rapid growth of deceased donation occurred after brain death became the accepted form of death, as defined by the ad hoc Harvard Committee in 1968 [3]. Historically, Dr. P.K. Sen in Mumbai had attempted the 1st heart transplant, the same year in 1968, and this was also the 6th such transplant attempt in the world.

Deceased donor transplantation has been the forte of the developed countries for the last 50 years, and it has been a major source of organs. It is estimated that over 67% of all transplants done worldwide are done from deceased donors [4]. In 2017, there were 139,024 solid organs transplanted and of these, 10% were hearts and lungs (Fig. 1).

Fig. 1.

Worldwide solid organ transplant activity (living and deceased) in 2017

The deceased donation programme evolved and became the standard of care to overcome organ shortage in most of the developed countries. Very few developing countries in the world were able to successfully implement this programme, and in this respect, India is an exception. Today, the growth of the heart transplant programme makes it the number one heart transplant programme in the South Asian region.

Early challenges

The passage of the organ transplantation law in 1994 (THOA) with the rules being passed in 1995 did not bring the expected changes in the country. Making organ commerce illegal and a punishable offence however did not bring down the numbers of unrelated commercial kidney transplant, and what was being practised in the open, before the law was passed, was now being done seemingly to be facilitated by the government’s appointed authorisation committee, instead of preventing it [5]. The lack of investment from the government to promote the relatively new concept of brain-stem death and the general lack of interest from leading transplant clinicians made the programme a non-starter. Added to this was the lack of awareness about the possibility of organ donation after brain-stem death, and this was as much among the medical professionals, as it was among the general public. In 5 years from 1995 to 2000, there were only 33 hospitals in the country which had taken up the deceased donation programme and among these, only four hospitals had started the heart transplant programme [6]. All India Institute of Medical Sciences (AIIMS), New Delhi and the Madras Medical Mission Hospital in Chennai were the two leading hospitals in the initial years of the programme. Another two hospitals from Chennai—Sri Ramachandra Hospital and Apollo Hospital—joined the list within a year.

The process of ‘brain-stem death certification’ was new, and before the law, it was seldom attempted or performed by neurologists or neurosurgeons; however, the transplant law had made them the custodians of such a declaration. The added irony was that the intensive care clinicians, who worked the hardest in managing these patients, were excluded from the declaration process and were not part of the four clinicians who were to perform the tests for certification twice, 6 h apart. Hence, starting the deceased donor programme in a busy tertiary care hospital was a rarity and even if a few donations were done due to a few individual clinicians championing the cause, sustaining the programme was increasingly difficult. The referral government hospitals, which admitted possible potential organ donors with head injuries after road traffic accidents, did not possess the infrastructure, sufficient ventilators or a transplant programme to be interested in promoting the concept of donation after brain death. Hence, it was left to a handful of private hospitals in a few states to keep the programme going. The number of donations averaged from 50 to 60 a year, with about half a dozen hospitals in the country contributing to most of these numbers. It was mostly kidneys that were utilised, and the heart utilisation was about 15% from these donors. Up to the year 2000, less than 50 hearts had been transplanted in the country [6].

An occasional successful heart or lung or liver transplant story in the press kept the ‘feel good factor’ alive in the community about the nobility of the cause and would sometimes propel the fledging programme forward. The programme provided the only hope of living to the hundreds who waited anxiously to receive an organ from a deceased donor.

What helped the most in building the future of this programme, as we see it today, was the formation of a small ‘Organ Sharing Network’ in the year 2000 by a non-governmental organisation (NGO) called the Multi Organ Harvesting Aid Network (MOHAN) Foundation with the help of a group of clinicians from five leading transplant hospitals in Chennai [7, 8]. The objective was ‘to share organs and not waste them’. This initiative ensured monthly interaction between the transplant clinicians, and this continued for 8 years; the hospitals shared 681 organs and tissues mainly the kidneys, liver, heart and corneas; however, at that time, the hearts comprised only 3.2% of the total [9]. Early on, it was realised that the role of a dedicated ICU consultant to manage the donors and counsellors to support the family in their moment of grief was the key to the success of the programme.

Tamil Nadu showing the way forward

The small success of this pilot in Tamil Nadu was being discussed by many programmes across the country, and the model was replicated in Andhra Pradesh in 2002–2003 with MOHAN Foundation starting an office in Hyderabad. Prior to this, the state had never done deceased donation, but soon after in 2004, the first heart was transplanted [10]. In 8 years from 2002 to 2009, the state had generated and shared 352 organs and tissues, of which seven hearts were shared [9].

In the years from 2000 to 2008, the organ sharing was mostly restricted to the kidneys and occasionally, only the liver or heart was utilised, as there were only three hospitals in Tamil Nadu and two hospitals in Andhra Pradesh that were capable of doing heart transplants. In the first 10 years, only four states in India had started the heart transplant programme and it took another 10 years for states like Maharashtra to start such a programme (Table 1). The system of sharing for hearts was to offer the organ in rotation to the hospitals.

Table 1.

First successful heart transplant in India - State/Union Territory (UT) wise

First successful heart transplant in India—state/union territory (UT) wise
S. no.	State/union territory	Name of the surgeon	Year
1	New Delhi	Dr. P. Venugopal	1994
2	Tamil Nadu	Dr. K. M. Cherian	1995
3	Kerala	Dr. Jose Chacko Periappuram	2003
4	Telangana	Dr. Alla Gopala Krishna Gokhale	2004
5	Karnataka	Dr. P. V. Rao	2008
6	Rajasthan	Dr. Murtaza Chishti	2015
7	Maharashtra	Dr. Anvay Mulay	2015
8	Andhra Pradesh	Dr. Alla Gopala Krishna Gokhale	2016
9	Madhya Pradesh	Dr. Anil Bhan	2018
10	West Bengal	Dr. K.M. Mandana and Dr. Tapas Raychaudhury	2018

During the first 10 years, the NGO conducted multiple workshops for intensive care unit doctors, surgeons and nurses on issues related to brain-stem death and counselling of relatives and standardising organ retrieval techniques. Breaking the bad news and asking for organs were the key areas of hesitation. As the home eye donation programme was fairly popular in the country, a protocol was devised, where the eye would be asked for first, in order to test the relatives’ sentiments before asking for solid organs. This protocol became known as the ‘Ramachandra Protocol’ to ask for organs [11].

In the year 2006, 2 years after the tsunami that had hit the coast of Tamil Nadu and taken a huge human toll, a story broke out in the media about the exploitation of the fishermen, who had been hit by the tragedy, having to sell their kidneys to meet their financial requirements [12]. These media reports of victimisation of the tsunami population became an embarrassment for the government of Tamil Nadu and required some action to restore the trust of the people [13–15].

The state health department decided to call for a consultative meeting of all the stakeholder hospitals, doctors and NGOs [16]. The outcome of this exercise resulted in the issuance of 10 landmark Government Orders on organ donation and transplantation, which covered all the gaps in the transplant rules including how to certify brain-stem death, how to manage medico-legal cases and how to share organs. Many of these were subsequently absorbed in the amended 2011 transplant law and 2014 rules that were passed by the Government of India. These orders created a centralised body for organ sharing in Tamil Nadu and brought all the hospitals in the state, which were undertaking organ transplantation, together to be ably assisted by an Advisory Committee consisting of senior government officers of various departments and the two NGOs in the state, along with representation from major government and private hospitals that were doing transplants. A state Convenor for the programme was appointed to run the affairs, who would directly report to the Principal Secretary of Health and Family Welfare of the Government of Tamil Nadu [17]. The online organ sharing registry developed by MOHAN Foundation was adopted and tweaked to start the Tamil Nadu Network for Organ Sharing [18].

Organ sharing and distribution

The organ sharing and distribution system, which was evolved in Tamil Nadu, was based on transparency, equity and fairness in the distribution of organs. The disadvantaged patients in the government hospital were given a slight edge over patients from private hospitals. Tamil Nadu in 2008 was doing kidney, heart and liver transplants free of cost for poor patients in public sector hospitals.

As immunosuppression for life is taken care of by the state, the post-operative compliance with medication gave the patient a better chance to lead a normal productive life.

Current status of heart transplantation

Although the Indian organ donation rate is less than one per million population (0.67 pmp in 2018), the number of heart transplants has doubled from 2015 to 2018 (Fig. 2). This is expected to grow even higher as more hospitals join the national programme. The average heart transplant rate was 0.2 pmp in India versus the global average of 1.06 pmp (2016-2018). The heart transplant rate in India increased from 0.01 pmp in 2012 to 0.18 pmp in 2018 as compared to the global heart transplant rate that rose from 0.84 pmp to 1.09 pmp in the same time period (Fig. 3).

Fig. 2.

Deceased Organ donation in India (2012-2018)

Fig. 3.

Total heart donation and transplantation activity -  Global vs India (2012-2018)

The national body that records, regulates and facilitates the country’s organ transplantation is called the National Organ and Tissue Transplant Organisation (NOTTO) and is based in Delhi. Currently, 250 hospitals are registered to handle solid organ transplants in the country and of these, 108 undertake heart and 63 lung transplants [19]. If we compare the population of the country with the burden of the need for transplants, it is a small number. In 2019, of the 37 states and union territories, only 16 did donation after brain death or deceased donation (Fig. 4). Of these, only about five to six do it regularly and have a proper system for organ donation and allocation. When we say India’s donation rate is 0.67 pmp, that is 875 donors in a year (2018), the bulk of the figures reflect the donations from these few states [20].

Fig. 4.

Deceased organ donation in India (2019)

If the programme was to become ‘Pan-India’, this figure would be much higher. NOTTO, which has the responsibility to promote and regulate the deceased donor programme in the country, is also directly responsible for doing the same for the city of Delhi, but so far, the number of hearts being transplanted in the capital has been low compared to the rest of the country [19].

The lack of financial support from the government or insurance coverage has meant that most heart and other such transplants are possible only for the affordable class and the less affordable do not have access to it. This lack of universal access gives the tag that the programme only caters to the needs of the rich and not only creates distrust in the system but also makes a family think twice when it comes to organ donation. Needless to say, the financial burden of a heart transplant expense is another big hurdle to the growth of this programme. The costs can also escalate, where chartered airlines are used to transport the heart from a distant location [21]. In this situation, there may be no Indian who is able to afford the heart and this may have resulted in some hearts being transplanted to foreigners [22]. The media has used this news to discredit the programme and has created distrust in the system, and this may be the reason for stagnation in numbers in the last 2 years (2018 and 2019) [23, 24].

Another challenge has been the lack of conversion of potential donors to actual donors, despite there being a large pool of trauma victims, who have potential brain deaths. Bulk of potential donors go unidentified. In 2018, India had 467,044 reported road accidents, an increase of 0.5% from 464,910 in 2017, according to the road ministry’s data. India has 1% of the world’s vehicles but accounts for 6% of the world’s road traffic accidents, according to data from a 2018 World Health Organization report [25]. Proactive declaration and early identification of brain dead patients could improve the organ donation rate in India [26].

Most donors in India are young compared with the donors from the West, where the age of donors has been rising as the road traffic accidents have gradually come down. The short ischaemia time with heart donation also means that the logistic challenges, such as cost of transportation of heart, distance, lack of night landing facility for an aircraft in tier three city airports and sometimes non-availability of a suitable recipient, make it difficult to utilise the organ.

At this point, one also needs to consider the dichotomy in the organ donation ecosystem, where most deceased donors from trauma end up in the government medical college hospitals, where there are no facilities for organ transplants; however, the majority of the recipients are in private hospitals.

The way forward

There is an urgent need to increase the low donation rate to help improve the rate of heart and lung transplant surgery and bridge the gap between the demand and supply. The following suggestions, if implemented without much extra resources, would benefit the deceased donation programme:

1. Strengthening the national programme—The southern and western regions in India have a number of transplant hospitals in the country and do the maximum number of transplants of organs from brain dead donors. The national programme needs re-organising and strengthening to work independently. The law mandates that the ‘National Organ and Tissue Transplant Organisation (NOTTO)’ plays an important role in regulating and spearheading a national programme that has an all-India presence. The current method has been in existence for almost 10 years, and the progress has been slow. NOTTO requires more manpower, resources and financial autonomy to facilitate organ donation awareness and transplant-related activities. A national consortium of all stakeholders should be made as advisory body, which can help in creating a national task force under the national programme and provide their recommendations. A decade ago, the UK took such a step and it helped in improving the organ donation rate [27].

2. Establish an Indian heart and lung transplant registry—This registry could record the number of transplants done, along with follow-up data, to portray short- and long-term outcomes of heart and lung transplantation in India. This information would help in formation of future policies, build credibility and enhance physician-patient-public involvement in heart transplants. The Transplantation of Human Organs and Tissues Rules, 2014, provides a mandate to NOTTO, the national body for such a registry [28]. The functioning of such a registry should take help of the national transplant societies and clinicians to review the data from time to time and make recommendations for improvement of the programme.

3. Increasing the organ donation rate—Currently, there are 550 transplant units in about 250 hospitals that undertake transplant surgeries of the kidneys, liver, heart and lungs. But less than 10% of transplantation surgeries are happening in about 33 government medical college hospitals. Of the nine AIIMS, only one AIIMS hospital in Delhi has the capacity to do transplants. All medical college hospitals in India are well equipped to do organ retrieval surgery, and many are capable of performing organ transplants. In the first instance, all the 532 medical college hospitals in the country, including the 260 government colleges and eight AIIMS [29, 30], should start doing organ retrieval surgery. This simple strategy would provide a big boost to the programme.

4. Donation after circulatory death (DCD)—In the last 10 years, many countries are re-visiting DCD. Interestingly, before brain death became the way forward, donation after circulatory death was being practiced in some hospitals and the first heart transplanted in 1967 by Christiaan Barnard was retrieved from such a donor in Cape Town, South Africa [31]. DCD may also be more acceptable to the general public, who sometimes struggle with understanding the concept of brain death. In the UK and the Netherlands, the donation rate increased by 33% after implementing this form of donation [32]. It should be possible in India too to look at this form of donation and create guidelines to implement it. What also needs to be defined is the ‘No Touch’ time in India [33]. Even in the current situation, Maastricht type IV DCD should be possible, where consent has been obtained after brain death and the unstable patient crashes. Some institutions in India have started DCD using this category of patients and have utilised the kidneys [34].

• e.Creating cross-subsidy through viable public private partnership—In the interim period, while the capacity to increase organ donation and transplantation takes place in public sector hospitals, we need to look at innovative ways of helping the less affordable patients to undergo transplantation of organs such as the heart and liver, through innovative and sustainable public-private partnerships. For example, whenever there is a deceased organ donor, who donates five or more organs, at least one organ could go to the less affordable patient suffering from organ failure like the kidney, heart or liver from public sector hospitals.

• f.Improving regulations—All this can only happen if we have enabling laws and regulations. The current law has certain gaps that need to be addressed. We lack regulations about the acceptance of brain death as a concept. Brain death is linked to organ donation, and this creates a problem when relatives do not wish to donate. The dead patients are unnecessarily kept on ventilators and the hospital bill escalates [35]. Regulation and guidelines are required to address this issue, by providing for a uniform definition of death, by delinking brain death from organ donation.

The state governments of Kerala and Gujarat have recently passed Government Orders (2020) mandating that all treatments, including cardiorespiratory support, must be discontinued once brain-stem death is pronounced. The Kerala Government Order makes no mention of organ donation [36], while the Gujarat guidelines state that if the family does not give consent for organ donation, cardiorespiratory support must be discontinued. These orders would provide further clarity to intensive care doctors when relatives say no to donation.

• g.Cost of post-transplant immunosuppression—The medications after transplant are expensive and government through its pharmacies can help provide these through bulk purchase and bring the costs down. This will help with better compliance and overall long-term results of the transplants.

• h.Need to establish Centre of Excellence for Transplants in every state/smart city—All medical college hospitals (532) should become transplant hospitals by 2025. Every smart city could have one or more ‘Centres of Excellence for Transplants’, and this should be included as part of the smart city project.

• i.Transport of organs—To ensure maximum utilisation of organs, an efficient transport system is required in the sharing network between different states of the country. Even within a city, the traffic congestion has required establishment of ‘Green Corridors’. However, there have been challenges during inter-city transfers and at times, the airports in the tier two or three cities have had no night landing facilities. The Indian Air Force has helped from time to time in organ transport [37, 38]. However, this should be made available as and when required to ease these challenges. The use of drones too is being experimented for organ transport within a city and in the future may be another method for organ transport. This will avoid the need for green corridors and help ease the inconvenience caused to the general public by stoppage of traffic [39, 40].

Transplantation surgery is always at the cutting edge of medicine, and a hospital that has this facility is generally considered to be an advanced medical centre. Heart transplant surgery has an emotive appeal from the public perspective and is the best transplant surgery, when it comes to promoting the noble concept of organ donation. In India too, there have been examples of the ‘feel good factor’ that have happened when a heart has been transplanted without consideration of caste, creed, religion or geographic boundaries. Some such examples have included a heart getting transplanted to a less affordable patient from a government sector hospital from a donor from a private hospital, a child getting a heart transplant [41], a Hindu donating the heart to a Muslim or a Pakistani getting an Indian heart [42]. Despite the multiple challenges, the last 10 years have seen encouraging growth of the programme. What is required at this stage, as we look ahead, is to bridge the disparities and make heart transplants available universally to all who require it, irrespective of their affordability. Innovative thinking is required to be put in place to make transplant surgery available to all. Ayushman Bharat Yojana (National Health Protection Scheme) promises health to the less affordable and has already included support for kidney transplant surgery [43]. India has a huge cost advantage compared with the developed countries plus we have well-trained medical manpower. What we need to remember is that in India, we have accomplished what may be seen as impossible to the outside world, with the lowest possible investment. One of the biggest examples of judiciously using money is ‘our mission to Mars’ [44]. If we are able to create a successful model for heart transplantation in India, it will not only benefit our own citizens but also help other developing countries to emulate our example. In the process, we would have accomplished what seems insurmountable to many within and outside our country.

Compliance with ethical standards

Funding

Nil.

Conflict of interest

The authors declare that they have no conflict of interest.

Research involving human participants and/or animals

No human participants or animals as this is a review article.

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