Dr.Sunil Shroff, Dr.Sumana Sundaram, Dr.Georgi Abraham, Dr.Sounddarajan, Dr.Suresh, Dr.Subba Rao, Dr.Paulose Thomas

Introduction

Patients& Method

Results

Discussion

References

Introduction

Since the passing of the legislation in India, entitled, ‘Transplantation of Human Organ (THO) Act’ in 1994, it has been possible to undertake multi-organ transplant activity from brain dead donors. The required pre-requisite for success of the cadaver program depend on various factors1-3 and these include:

1. Positive attitude of public towards organ donation
2. Consent by relatives for organ donation in event of brain
death.
3. Successful brain Death identification and certification.
4. Adequate hospital infra-structural and support logistics
5. Successful retrieval and transplantation of organs and
auditing long term graft outcomes.

This review looks at these aspects in the Indian context and discusses the difficulties encountered in implementing this program over the last 6 years.

Patients & Method

1. After passing of the THO legislation a major survey of the 5008 members of Indian public’s attitude towards organ donation was conducted in 1995-96 by the principal author and a brief analysis of this survey’s result are presented 4.

2. In one major hospital in Chennai, undertaking cadaver transplants regularly; an audit of 159 ‘Brain death’ patients over the last 5 years was undertaken. This was to look at the number of these patients who actually became organ donors.

3. Data of all the transplants centers in India undertaking cadaver transplants since the passing of the legislation was collated for this study.

4. Infra-structural Support services available at the hospitals undertaking the cadaver program was looked at and a critical analysis was made of the deficiencies.

5. The results of first 100-kidney cadaver transplant from 4 major hospitals in the country were analyzed to look at 1 and 2 year kidney allograft and patient survival.

Results

1. “Public attitude Survey to organ donation”: This survey showed 72% of the population were willing to donate eyes and carry a ‘Donor Card’, however less than 50% were willing to consider solid organ donation. 74% of Hindus, 72% Christians, 58% Muslims were willing to consider organ donation; however the concept of brain death was new to most of the people surveyed 4.

2. Organ donation in Brain death situation: An audit of 159 brain death patients showed that 30 or 19% of the relatives donated of the organs of their loved ones.

3. The Total Cadaver Transplants activities: For various solid organs5 are as follows from Jan 1995 to Jun 2001:

Kidney 379
Heart 34
Liver 12
Pancreas 02
Lungs 01
TOTAL 428

In the last 6 years 35 hospitals in the country from various regions have undertaken cadaver transplants. Chennai has done the maximum number of cadaver transplants in the country (189). Besides Chennai the other cites where the cadaver organ transplantation is taking place include New Delhi (68), Ahmedabad (46), Pune(32), Bangalore (32), Vellore (22), Mumbai (20) and Coimbatore (12).

4. Hospital Infra-structural and Support Logistics: All 35 hospitals were supported by intensivists and adequate Intensive care facilities and fully qualified and trained

medical and para-medical staff to undertake the cadaver transplant program.

However most of them lacked motivated medical or social workers who could be trained to speak to the relatives in brain death situations. There were only 15 transplant co-coordinators of whom very few had any proper or formal training in the field. There were about 12 organizations in the country working to promote and help out with the cause of organ donation however only 3 were actively involved and worked as a central co-coordinating agency for allocation and distribution of organs.

5. Results of the first 100 transplants from 4 major centers: The mean age of the patients was 45 years with a range from 3 years to 72 years. There were 62 males and 38 females transplanted. The one-year allograft and patient survival was 82% and 86% respectively and the 2-year allograft and patient survival was 74% and 80%.

Discussion:

The passing of Transplantation of Human Organ Act heralded a new era in Indian medicine. This legislation was written on similar likes as the UK Transplant Act. The essence of this legislation was threefold:

1. To accept brain death as also a definition of death.
2. To stop commercial dealing in organs
3. To define the first relative (father, mother, brother, sister, son, daughter and wife) who could donate organs without permission from the government. In event of the donor not being a first relative an approval had to be obtained by a government appointed authorization committee in each state of the country.

When the THO act was passed there were very few evangelist and many more detractors of this legislation. The evangelist in the country felt it would stop commercial dealing in organs, open up multi-organ transplant activity and increase the number of transplants in India. The detractors felt that this legislation was unlikely to succeed in the Indian context in view of the religious and cultural diversity, poor socio-economic background and lack of infra structural support available for implementing the cadaver transplant program.

The public attitude survey indicated a positive attitude of the people towards eye donation. After this survey a simple protocol was devised (Ramachandra required request protocol when asking for organ from relatives). It was suggested that’ Eyes’ should be requested for first and only if the relatives were willing other organs requested. This it was felt was less likely to upset the relatives in a brain death situation, and would also give the hospital staff asking for organs an idea about the family’s attitude towards the sensitive issue like organ donation in the difficult brain death situation4. The Eye donation activists of the country are already lobbying for a “required request law” in event of a death in a hospital. This is likely to be soon passed by the parliament and be enacted as a law. This same law can be extended for solid organs in a brain death situation. If this is done it can give the required boost to the program and make it obligatory for the hospitals staff to ask for organs.

A major center (Sri Ramachandra Research Medical College And Research Center) undertaking cadaver transplants in the last 6 years has had a brain death conversion rate of 19% (30/159). In this institution the ICU staff have been sensitized to the issue of brain death and organ donation. The number of fatal road traffic accidents every year in India is constantly rising and averages at about 8,500 per year. At any given time there are 8 to 10 brain dead patients in different ICU’s in any major city of the country. There is hence potentially a huge pool of brain death donors available in India6.

Most of the hospitals undertaking cadaver transplants are either private or trust

hospitals and there are very few government hospitals undertaking this program.
Out
of 27 states in India four states are still to enact the ‘Transplant legislation’ and accept brain death concepts. Hence to make the cadaver program a success a re-think of how to implement this program is necessary. One of the major hurdles seems to be the unrelated transplant activity that continues unabated. Kidney scandals still continue to haunt the country every so often. The unrelated activity is due to loop holes in the present THO Act as under the Sub Clause (3), Clause 9 of Chapter II it states: “If any donor authorizes the removal of any of his human organs before his death under sub-section (1) of section 3 for transplantation into the body of such recipient, not being a near relative as is specified by the donor, by reason of affection or attachment towards the recipient or for any other special reasons, such human organ shall not be removed and transplanted without the prior approval of the Authorization Committee”. It is not necessarily difficult to find an unrelated donor who suddenly develops an “affection or attachment” for the recipient provided he or she is properly rewarded. Most of the unrelated transplants are a result of the patients and clinicians using this section of the law to obtain permission from the Government to do live unrelated transplants. This aspect of the law has either to be scrapped or tightened so that only genuine cases are helped, otherwise unrelated activity will continue with the permission of government’s authorization committee.

Up to 1997 only four hospitals in the country were undertaking cadaver transplants. However, now more and more hospitals encouraged by the success of others are now indulging themselves in this program. On an average over 55 cadaver transplants are being undertaken in India every year. This is unlikely to meet the present demand for organs. It is estimated that every year there are 3500 kidney transplants are being undertaken.

As the cadaver program is still in infancy stage the early results of kidney cadaver transplants are acceptable. Two hospitals (All India Me Institutes of Medical Science, Delhi and Madras Medical Mission, Chennai) are undertaking heart transplants. Only one hospital, Indraprastha Apollo Hospital Delhi is undertaking liver transplants regularly.Over the last 2 years local state based networks are being established by a few non- governmental and non-profit motivated organizations in the country. Among these the Initiative for Organ sharing group started by MOHAN (Multi Organ Harvesting Aid Network) Foundation in Tamil Nadu has shared 68 organs in the last 2 years between five hospitals. This is a encouraging start to the program. The foundation is also hoping to affiliate with other similar organization in other regions such as FORTE (Foundation for Organ Transplantation and Education) at Bangalore & ZTCC (Zonal Transplant Co-coordinating Committee) at Mumbai that have also similarly shared organs between different hospitals.

There is potentially a huge pool of brain-death patients in the country who could not only meet the local demands of organs but may be able to meet the needs of some of the neighboring countries which sometimes looks towards India for their healthcare needs. Despite the many problem in implementation of this program in India a start has been made and the first hurdle has been crossed. Education of public on concepts of brain death and having more trained transplant coordinators, allocation of resources from government and private agencies for the program and having a state based network with a central network office would help to give this program the required boost in the country.

REFERENCES
1. Evans RW, Manninen DL: Transplant Proc 20: 781, 1988
2. Feest TG, Reid HN, Collins CH, et al: Lancet, 335:1133, 1990
3. Wakeford RE, Stepney R: British Journal of Surgery,
76:435, 1989
4. Shroff S, The Antiseptic, 94:73-74, 1997
5. Cadaver Transplant Activity – All India Figures – 1999 to
June 2001 Indian Transplant Newsletter 3:9, 4,2001
6. INOS and the essence of organ sharing- Editorial, Indian
Transplant Newsletter, 3-10, 2001

Institutions:

Sri Ramachandra Medical College & Research Institute, Chennai
Apollo Hospital, Chennai,
Christian Medical College, Vellore,
Sundaram Medical Foundation, Chennai
MOHAN (Multi Organ Harvesting Aid Network) Foundation, Chennai

http://www.medindia.net/articles/article5.asp

http://www.hinduonnet.com/fline/fl1522/15220920.htm

Donating lives

Heart transplantation can hold out hope for a large number of patients in India but a smooth donor mechanism will need to be put in place and the costs involved will have to become affordable to more people before the numbers of such procedures can reach levels comparable to developed countries.

RASHEEDA BHAGAT

IN a special room in Apollo Hospitals in Chennai, 36-year-old A.S. Subramaniam, who received the gift of a ‘new’ heart a couple of weeks earlier, spoke about the operation that gave him a new lease of life. According to him, the operation went through like a dream, the bill amounting to around Rs. 3 lakhs has been taken care of, and he is accorded “royal” treatment.

Yet, even as he speaks about his good fortune, a dark shadow clouds his face. While on the one hand he is happy that his four-year-old heart problem has been solved, Subramaniam, an executive engineer with Neyveli Lignite Corporation (NLC), is worried as to how he will raise the enormous amount of money required to maintain the foreign organ in his body.

After he suffered a heart attack in June 1994, Subramaniam required regular medical help. He told Frontline: “I was told by my cardiologist that the only remedy for my terminal heart problem was a transplant.” With a take-home salary of barely Rs. 7,000, Subramaniam, who has a wife and two children aged 11 and six years to support, had no hope of raising the Rs. 3 lakhs required for a transplant. However, when a donor organ became available and the Apollo Hospitals’ cardiac surgery team volunteered to perform the surgical procedure free of cost and take care of the material as well as hospitalisation costs, it was like a dream come true.

However, Subramaniam now has to raise Rs. 2 lakhs, which is required over the next 12 months for various medical tests and for immuno suppressants required to prevent rejection of the organ. The monthly expenses on immuno suppressants, such as cyclosporin, range between Rs. 4,000 and Rs. 10,000. (The dosage will come down progressively.) Subramaniam has no assets other than is ancestral house in a small town in Tamil Nadu. “Even if this house is sold,” he said, “my sister has to be given her share.” He has no idea about how much NLC will contribute towards his medical treatment.

BY SPECIAL ARRANGEMENT
A heart transplant procedure in progress at Apollo Hospitals in Chennai.

GAJANAND GUPTA, 39, was the first patient on whom a heart transplant procedure was performed at Apollo Hospitals in Chennai. After living with a diseased heart for 10 years, during which period he had to close down his business, he received a ‘new’ heart on December 24, 1995. “When I was in the hospital, I was told that my lifespan could be as short as four days or as long as 40 days. So, when the heart of a 28-year-old accident victim became available, I told myself: ‘I may die after four days. If the operation is not successful, I will die today. What difference will these four days make to my life?’ So I agreed to the surgery.”

Three years later, Gupta, who works as a ticketing agent for a domestic airline, is fit enough to meet the rigours of his job which requires him to do a lot of running around. “This is the best treatment in the world for myocardial patients,” he said, “provided you can afford it.”

BIJOY GHOSH
A.S. Subramaniam, who recently underwent a heart transplant surgery at Apollo Hospitals.

Although the Apollo Hospitals’ cardiac surgery team has been very supportive and he is certain that the doctors themselves pay for the investigations, Gupta still needs to raise the money for cyclosporin month after month. “Until now I have managed to get by on help from the doctors, my friends and relatives. But frankly, if I had known that it was going to require so much of money to keep breathing, I wouldn’t have gone in for the surgery. Unless you have the money, you end up being a beggar,” he said ruefully.

In a developing country such as India, the operative words are “afford it”. Although the most positive aspect of a heart transplant procedure is that it bestows a new lease of life on its beneficiaries, the prohibitive costs involved may prove to be a deterrent to many. Ironically though, most of the patients who have undergone a heart transplant are those who could not afford it and have had to depend on charity to pay for their immuno suppressants.

There are also people such as R.S. Sudarshan, a businessman who underwent a heart transplant at the Madras Medical Mission, who are able to bear the entire cost of the treatment. But people like him are few and far between.

THE high cost of surgery, medical investigations and the prolonged post-surgical medication is not the only factor that has kept the number of heart transplant procedures in India at an abysmal low. Donor hearts are also hard to come by.

Dr. M.R. Girinath, chief of the cardio vascular department at Apollo Hospitals, pointed out that even though the surgical aspect of a heart transplant is simple, the lack of awareness and the dearth of organ donors have led to a situation where the number of heart transplants performed in India is very low. Over the past four years only 25 heart transplants have been performed in the country. Dr. Girinath said: “The few attempts that have been made to increase public awareness about organ donation have not really paid dividends. Only when a family that is about to lose its loved one is approached by doctors to donate his or her organs does the message of organ donation crystallise. Until then it is only an empty thought.” He said that the most distressing aspect of waiting for donor organs is that a number of patients die before donors can be found.

T.A. HAFEEZ
Dr. K.M. Cherian of the Madras Medical Mission in Chennai.

Dr. K.M. Cherian, director of the Institute of Cardio Vascular Diseases run by the Madras Medical Mission in Chennai, where six heart transplants were performed over the last four years, is unhappy that even among the medical community, there is a near-total lack of commitment to the cause of transplant surgery. He said: “It seems that 40 cadaveric kidney procedures were done last year. Surely all those 20 people had hearts. I would like to know what happened to those 20 hearts? The MGR Medical University in Chennai established a Central Organs Registry last year. How many institutions that had cadaver kidneys contact this Central Registry to say ‘We have a donor with such a such blood group?’ If they didn’t contact the Registry, we should ask why.”

According to Dr. Cherian, the reason for this apathy is “jealousy and counter-productive competition” in the medical fraternity. He said that the All India Institute of Medical Sciences (AIIMS) had stopped performing heart transplants, and added that it was probably because of lack of coordination among the neurology, accident and cardiac departments. “We are not a centre where accident or neuro cases come,” he said. “We have to depend on other hospitals to get donors. We have been certified by the Tamil Nadu Government for performing heart, lung and kidney transplants and when we get a donor we are willing to extend our facilities to anybody who wants to perform a kidney transplant.” (A kidney transplant procedure was performed at his institute by a team from the Sri Ramachandra Medical College Hospital in Chennai.)

According to Dr. Cherian, the majority of the 79,000-odd people who die in road accidents in India every year are potential organ donors. Apart from the reluctance of the dying person’s relatives to donate the organs (organs such as kidneys, liver and heart have to be removed when the heart is still beating), another stumbling block is the requirement to constitute a panel of neurologists which has to certify that a patient is brain dead before his or her organs are removed. Dr. Cherian questions the logic behind appointing government doctors as members of these panels.

Of the six cases in which heart transplant procedures have been performed at the MMM, five patients are alive and doing well. September 23 marked the third anniversary of the first heart transplant procedure performed at the MMM. The recipient was Maimoona Beevi, a bangle seller. MMM observes this day as Organ Donation Awareness Day.

Dr. M.R. Girinath of Apollo Hospitals.

While Maimoona Beevi was the first woman on whom a heart transplant procedure was performed in India, the MMM has another first to its credit. The country’s first paediatric heart transplant was performed at the MMM about 18 months ago on an 11-year-old boy who suffered from cardio myopathy. The Pallavan Transport Corporation paid a part of the costs since the boy’s father was its employee. The remaining costs were borne by the MMM.

SINCE donor hearts are difficult to get, doctors have to be careful about the choice of recipients. Dr. Girinath said that he would choose patients “who have a life expectancy of less than six months without the operation.” “This means that they are in an advanced stage of heart failure and there is nothing else you can do for them.” In addition, the patients should not have very high pressure in the lungs and the arteries of the lungs and their other vital organs should be functioning well.

Dr. Cherian’s team does not use steroids. Dr. Cherian said: “Compared to others who perform heart transplants in India, we use a smaller quantity of immuno suppressants and have stopped using steroids, which is a conventional method of treatment.” According to him, non-use of steroids is the latest development in heart transplantation techniques. Dr. Cherian said that the 10-year survival rate for heart transplant patients is around 45 to 50 per cent.

Dr. P.V. Rao, a cardiac surgeon at Apollo Hospitals, who performed the transplant procedure on Subramaniam, said that despite the fact that the number of heart transplant procedures performed in India was only a fraction of those performed in the United States and Europe (each of which witnesses about 2,000 procedures a year), the future looked optimistic. “Heart surgery started in a very small way in India,” he said, “but today over 50,000 open-heart operations and one lakh closed-heart operations are being done. Tomorrow, if the costs come down or some technological advance takes place, we can make rapid strides in this area.”

However, until such a scenario emerges, most of the patients who need to undergo this procedure to survive will not be able to afford it. Dr. Girinath said: “We can waive the surgical and hospitalisation costs, but the biggest problem is to keep the patients going on the immuno suppressants after the surgery.”