Akanksha Singh (name changed) sits quietly on the stage while her doctor addresses the press conference. He is narrating her story; how a joyful picnic on the hills turned into nightmare for Akanksha (34) and her family when she became breathless and was diagnosed with end-stage heart failure. How within weeks her organs started to fail awaiting a donor heart and how she was saved by a pump till she finally received a heart transplant. An extraordinary feat for her doctor Dr KR Balakrishnan, Director Cardiac Sciences, Fortis Malar Hospital who used the Extra Corporeal Membrane Oxygenation device (ECMO) to buy time for Akanksha who recovered wonderfully and is event free two years down the line.
Having heard Akanksha’s story, one would think heart transplant has come of age in India but the real truth is far more worrying. Only a handful of hospitals in India perform heart transplants even though there are a number of cardio-thoracic and transplant surgeons experienced and capable of performing the surgery and a huge number of patients needing it.
Alarming gap
Heart failure is a major health concern worldwide including India. Twenty million people worldwide suffer from heart failure, of which India witnesses two million new cases every year with at least a third of them requiring advanced therapy to survive. “The incidence of end stage heart failure is increasing steadily, the approximate number is difficult to comprehend. In India, it has been estimated that there are about 19 million (1.9 crores) patients with heart failure (HF) with 1.5 million new cases per year,” says Dr KM Cherian, CEO and Chairman, Frontier Lifeline, Chennai and the pioneer of heart transplant in the private sector.
It is also important to note that the mortality in heart failure patients is as high as 30-40 per cent, within a year of diagnosis. In India, the treatment for heart failure is restricted to medical therapy, revascularisation therapy (restoration/augmentation of blood supply to the heart), valvular surgeries and cardiac resynchronisation (heart pacing) therapy.
Worldwide, a total of 4,096 heart transplants (including 3,529 adult) from 249 centres were performed in 2011 and reported to the International Registry for Heart and Lung Transplantation. According to the 30th adult heart transplant report, over 110,486 heart transplants were conducted in over 407 centres since 1982 through June 30, 2012.
Challenges
Heart transplant in India faces many challenges, but the most glaring of them concerns organ donation. “All over developed countries, the main problem is the availability of donors as there are always a huge number of patients waiting for transplantation and many of them die while waiting for donor heart,” explains Dr Alla Gopala Krishna Gokhale, Heart & Lung Transplant Surgeon, Yashoda Hospitals, Secunderabad. Although the Zonal Transplant Coordination Committees across India are making dedicated efforts to spread the word on organ donation not many states have been able to coordinate dedicated efforts for the same. “Donation is happening to some extent only in Tamil Nadu and Hyderabad. For e.g. in the last one and a half years, in Hyderabad, Jeevan Dan mobilised 60 organ donors. Of these 55 livers and 115 klidneys were used and only two hearts were used. In these cities, the main problem is availability of recipients,” says Dr Gokhale. “It is mainly because of lack of awareness among public and medical fraternity and especially cardiology faculty is showing apathy to this group of patients and not directing them properly,” he adds.
Logistics
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“Even though there is now a fairly active transplant programme, we still have a situation where organs are wasted.”Sometimes the donated organ gets wasted as it is not able to get to the patient on time. “Even though there is now a fairly active transplant programme, we still have a situation where organs are wasted,” laments Dr KR Balakrishnan, Director, Heart Transplantation and Mechanical Circulatory Support, Fortis Malar hospital, Chennai. “When you have a sick patient needing an urgent transplant, an organ may not be available, or the best recipient for that organ may be in another location, and transporting the organ is not often possible over longer times and distances as we are also faced with a time limit of around four hours of ischemia for the heart, after which the heart is not usable,” he explains.
Orchestrated efforts from surgeons, traffic personnel and public have in the past proved life-saving for some patients. ‘Green corridor’ or ‘Corridor of Life’ are red-light free road access to transport donated organ to the suffering patient.
Rising costs
Cost of surgery is one of the main deterrents to heart transplant. “The main challenges with heart transplant in India are the cost of transplant and the cost of immunosuppressant medicines post transplant which is approximately Rs 30,000 per month as per rates now,” says Dr Cherian.
Besides there are no option for heart transplant in medical insurance. “It costs about Rs 15 lakhs for surgery and about Rs 30000 for monthly maintenance. In developed countries, 85 per cent people have insurance whereas in our country 85 per cent pay from pocket. Insurance companies and government have not taken the initiative to promote this treatment option,” says Dr Gokhale.
Evolution of heart transplant in India
Despite the rising challenges India has managed to keep the option of heart transplant open for patients. Collectively, 129 heart transplants have been performed in India since 1994 with 82 in Chennai, 33 at AIIMS and 14 at other centres in India. At KEM Hospital, Mumbai, Dr PK Sen and his team performed the first heart transplant in India in February 1968, months after the first attempt at heart transplant was made by Christiaan N. Barnard in December 1967 at South-Africa. Barnards’s patient lived for 18 days while Sen’s patient died within 24 hours, this was before immuno-supressing drugs were made. After 1968, Dr Sen and his team did perform other heart transplants but the surgery did not yield positive results. By the time organ rejection suppressing drugs became available, many other problems cropped up in India. Primarily, the unclear law relating to organ transplant. By early 1980s the surgeons began to lobby for a clearer law. “In 1983, Former Secretary of Health, Govt of India, Dr Srinivasan called for a meeting of representatives from various groups of society,” recalls Dr Cherian. “This meeting was conducted at Vijay Hospital and attended by priests of different religions, judges, advocates etc and there were more than 500 people that participated and unanimously approved that the brain dead should be legalised. This was the first meeting ever conducted in India and later followed by Delhi, Kolkata and Mumbai,” he adds.
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“Success of heart transplantation is related to the discovery of effective immunosuppressive regiments and the methods for managing acute rejection.”In the meantime, Dr P Venugopal and his team at the department of cardiothoracic and vascular surgery, AIIMS Delhi, were fine-tuning heart transplant surgery techniques by experimenting on animals. The Organ Transplant Bill 1994 was passed in the Indian Parliament in May 1994 which cleared the way for organ harvest from brain-dead patients. Successively, Dr P Venugopal and his team performed the first successful heart transplant on August 3, 1994. However, the full extent of the law and notification happened in 1995 after which other centres in India performed the surgery successfully.
“The brain dead legalisation was brought about in June 1995 and it was passed in the Upper and Lower House. After legalisation of brain dead, I believe we performed the first successful transplant in Vijaya Hospital, Chennai,” recalls Dr Cherian.
Since then there has been no looking back. “India’s first heart transplant was performed at AIIMS on August 3, 1994. From a few sporadic transplants at that point in time, we now have a fairly well organised programme in place,” says Dr Bagirath Raghuraman, Senior Consultant Interventional Cardiologist & Heart Failure Specialist, Narayana Health City, Bangalore.
Vital statistics on heart transplant and knowledge sharing has suffered due to the lack of a registry. A registry has been launched recently which will start providing data soon. “We do not have statistics and actual numbers of patients needing heart transplant in India,” informs Dr Raghuraman. “We have recently formed the ‘Heart Failure Association of India’ which has embarked on the task of collecting heart failure data from all over the country. We will have meaningful figures by the end of the year,” he adds.
| Surviving stars |
| Louis Washkansky was the first recipient of heart transplant in South Africa by Dr Christian Barnard. He survived the operation and lived for 18 days |
| Tony Huesman is the world’s longest living heart transplant recipient who survived 31 years. He received a heart in 1978 at the age of 20 after viral pneumonia severely weakened his heart. Huesman died on August 10, 2009 of cancer. He was operated at Stanford University under heart transplant pioneer Dr Norman Shumway |
| Elizabeth Craze, now 32 years old, an IT employee working for Facebook in Palo Alto is one of the youngest successful heart transplant recipients in the world who received transplant at the age of two years and 10 months |
| Kelly Perkins climbs mountains around the world to promote positive awareness of organ donation. Perkins was the first recipient to climb the peaks of Mt. Fuji, Mt. Kilimanjaro, the Matterhorn, Mt. Whitney, and Cajon de Arenales in Argentina in 2007, 12 years after her surgery |
| Twenty-two years after Dwight Kroening had a heart transplant, he was the first recipient to finish an Ironman competition |
| Fiona Coote was the second Australian to receive a heart transplant in 1984 (at age 14) and the youngest Australian. In the 24 years after her transplant, she became involved in publicity and charity work for the Red Cross, and promoted organ donation in Australia |
| A 71 year old in Australia is the oldest person in the world to undergo heart transplant |
Advances in heart transplantation
Heart transplantation is evolving and now has excellent outcomes. “The success of heart transplantation is closely related to the discovery of effective immunosuppressive regiments and the methods for managing acute rejection,” says Dr Cherian. Agreeing Dr Balakrishnan says, “The advances in heart transplant in recent years has been in the use of more sophisticated and gentle immunosuppressive drug therapy so that the harmful effects of these drugs are minimised and patients live much longer.”
Another promising advancement has been in normothermic organ preservation, which provides warm blood perfusion of the donor organ, potentially decreasing reperfusion injury and graft dysfunction. Experts believe that if proven effective, this technology may decrease early graft failure and allow increased utilisation of available organs. Its potential to decrease ischemic time may also give greater opportunity for prospective cross-matching in heart transplantation.
Talking about the organ care system developed by a US-based company, Dr Raghuraman says, “After a heart is removed from a donor’s body, it is placed in a high-tech organ care system box and is immediately revived to a beating state, perfused with oxygen and nutrient-rich blood, and maintained at an appropriate temperature. The device also features monitors that display how the heart is functioning during transport.” The box is not widely available in India. “If this box is made available in India, it may be possible to keep donor hearts viable for longer periods given our country’s infrastructural limitations,” says Dr Raghuraman.
Better outcomes with Ventricular Assist Devices (VADs)
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“Main problem is availability of donors as there is always a huge number of patients waiting for transplantation and many die while waiting for donor heart.”Ventricular Assist Devices (VADs) are implantable mechanical heart pumps. They have been used in recent times to sustain patients who are candidates for heart transplant as they await a donor heart and are increasingly being used as a substitute for transplantation. “Emerging research shows that VAD patients find that their hearts actually improve with help from these mechanical pumps,” says Dr Balakrishnan.
VADs have also evolved with time. “In the beginning left VADs (LVADs) were not very sophisticated and had moving parts, which created noise,” explains Dr Balakrishnan. “The current breed of LVADs are magnetic levitation devices that are much smaller and advanced,” explains Dr Balakrishnan. “With a fourth generation LVAD, we don’t need to cut open the abdomen, or even the diaphragm, to fit the machine. It’s intrapericardial and doesn’t even encroach upon the lung space. The latest circulite LVAD can be placed in the muscles of the right side chest wall and is a little bigger than a pacemaker in size,” says Dr Raghuraman.
Speaking about his experience Dr Cherian says, “There are two methods of supporting the failing heart. Firstly, a bridge to the transplant and secondly a destination therapy.”
“The bridge to transplant has been done by us couple of times and one patient had the heart transplant after being given artificial support heart for 39 days,” he informs. “The cost of this device will be around Rs 25 lakhs. This involves the cost of machine and other expenses etc. For the first time in Asia officially an artificial heart transplant (HeartWare) was done at our Frontier Mediville on July 15, 2014,” he says.
The cardiac transplant team at Fortis Malar has so far performed 16 heart-transplants, five VADs and is credited with India’s first successful implantation of Heartmate II LVAD and HVAD, a mechanical artificial heart pump.
Narayana Hrudayalaya, one of Asia’s first hospitals to implant total artificial hearts from an Australian company, Ventracor in 2008, has reported success of artificial heart implants in their patients.
The road ahead
India can emerge as a major player in the heart transplantation scene in the future. “We have the facilities, trained specialists and infrastructure to go the distance. Improving the existing facilities to world class standards holds the key,” says Dr Raghuraman.
Surgeons are hopeful of increase in the number of organ donations in future. “It is going to go only one way. Donation rates are going to go up and heart transplantation will become a common surgery. How long it will take I do not know but I am hoping that by the end of coming 10 years, it will be available to many and many will utilise it,” opines Dr Gokhale.
“Already there is a lot of interest in several states to start cadaveric transplant programmes modelled on what is being done in Tamil Nadu. I expect in the next few years, the numbers will grow substantially once awareness about organ donation is created across the country,” says Dr Balakrishnan.
Bringing down the cost of surgery will be a sure mantra for success. “The future of heart transplant in India is dependent on the involvement of the private and government sector in bringing down the cost of medicines and immunosuppressants. It depends on the knowledge among the layman for donation. Organ donation awareness is a must,” shares Dr Cherian.
Focus on innovation in VADs is also expected. “We need a reliable and affordable LVAD to keep critically ill patients alive till a suitable donor organ is found,” says Dr Balakrishnan.
The consensus and involvement of insurance for heart-transplants is a must to uplift the intervention. “We need to bring heart transplantation and organ transplantation in general under the gambit of health insurance and the national health programme. Funding such programs will immensely benefit these patients. Availability of costly immunosuppressive medications at subsidised rates will ensure better compliance with medications and lesser drop out rates. Educating the general public, awareness programmes and public participation can immensely change the scenario. It is a question of time before the bits of the jigsaw puzzle fall in place. We look forward to a change in the fortunes of these unfortunate people and be the hope for the hopeless,” concludes Dr Raghuraman.
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