|INVITED REVIEW ARTICLE
|Year : 2016 | Volume
| Issue : 1 | Page : 12-17
Kidney transplantation in India: Challenges and future recommendation
NP Singh1, Anish Kumar2
1 Department of Medicine and Allied Specialities, Max Super Speciality Hospital, Vaishali, Ghaziabad, Uttar Pradesh, India
2 Department of Medicine, Max Super Speciality Hospital, Vaishali, Ghaziabad, Uttar Pradesh, India
|Date of Web Publication||25-Jan-2016|
N P Singh
Department of Medicine and Allied Specialities, Vaishali, Ghaziabad, Uttar Pradesh
Source of Support: None, Conflict of Interest: None
Successful kidney transplantation offers the best possible quality of life for patients with end stage renal disease (ESRD). Despite this, renal transplantation rates in the developing world are considerably lower than in the developed world. Identified reasons for this include lack of awareness, low education levels, lack of a clear national policy, absence of functional dialysis and transplant units with adequately trained staff, and absence of an organized system of organ retrieval from deceased donors and lack of opportunities to fund long-term immunosuppression. Measures to improve the quality of care should center on improvement of the socioeconomic status of the country. Key action points include the implementation of: (1) Chronic kidney disease (CKD) screening and prevention programs; (2) ESRD and transplantation registries; (3) transplantation legislation, covering both living and deceased organ donation; (4) international and regional collaborations for transfer of knowledge and technology. The government should make transplantation more affordable by strengthening the public sector hospitals and by making the transplant medication more affordable. With the National Organ Transplant Programme (NOTP) in the process of being established in India, the transplant community should strive to increase the organ donation awareness, improve the infrastructure for organ retrieval, storage and allocation in an equitable way.
Keywords: Donor, end stage renal disease, kidney transplantation, renal replacement therapy
|How to cite this article:|
Singh N P, Kumar A. Kidney transplantation in India: Challenges and future recommendation. MAMC J Med Sci 2016;2:12-7
| Introduction|| |
Chronic kidney disease (CKD) is a common and rapidly increasing global public health problem, both in developed and developing countries. The global prevalence of CKD is estimated to be 8-16%, and the disease burden is expected to grow. In India, recent studies have shown a variable prevalence ranging from 4% to 17.2% with wide regional differences., Globally, CKD is associated with high morbidity and mortality with approximately 735,000 deaths annually. Thus, CKD is the 12th most common cause of death and the 17th most common cause of disability. End-stage renal disease (ESRD) represents the terminal stage of CKD and is defined by a glomerular filtration rate of <15 mL/min/1.73 m2. There is a paucity of data in India regarding true incidence of ESRD. An Indian population-based study determined the crude-and age-adjusted ESRD incidence rates at 151 and 232/million populations.
Different modalities exist for renal replacement therapy (RRT), such as hemodialysis and peritoneal dialysis; however, kidney transplantation (KT) remains the treatment of choice for ESRD as it leads to longer survival and superior quality of life. It is estimated that in India, 3500 patients undergo renal transplantation, 3000 new patients are put on continuous ambulatory peritoneal dialysis, and more than 15,000 patients begin maintenance hemodialysis in a year. ESRD treatment imposes a major financial burden on citizens in underdeveloped countries, and among all forms of RRT, KT was found to be least expensive., The first successful renal transplantation in India was performed in 1971 by the team led by Dr. Mohan Rao and Dr. KV Johny at Christian Medical College, Vellore. Since then, the program of renal transplantation has come a long way. The objective of the present review is to address the challenges encountered in KT in India and make recommendations for a successful renal transplant program.
| CurrentGlobal andIndian Scenario|| |
Recent data demonstrate that, globally, 2.6 million people were on dialysis in 2010, with 93% in high-or upper-middle-income countries. However, the number of people requiring RRT was estimated at 4.9-9 million, suggesting that about 2.3 million died prematurely because of lack of access to RRT. By 2030, the number of people receiving RRT around the world is projected to increase to 5.4 million. Most of this increase will be in the developing countries of Asia and Africa. In India, today, more than 200 centers are carrying out KT that depends heavily on living donors from near relatives. However, as per the Indian transplant registry maintained by the Indian Society of Organ Transplantation (ISOT) on their website http://www. transplantindia.com/, a total of 20,952 kidney transplants have been reported to them till date from a total of 48 centres only. As compared to cities, the awareness and affordability are lower in most regions of the country. Apart from money, availability of live-related donor is a major cause for the ever increasing gap between the patients awaiting a KT and the patients who get a KT and results in a gross mismatch between demand and supply. Statistics suggests that about 150,000 people in India are waiting for renal transplantation. Only 1 out of 30 people who need a kidney receives one. Ninety percent of people on the waiting list die without getting an organ. Deceased donor (cadaveric donor) transplant can bridge this gap to some extent and can reduce the waiting time for KT and also the commercial transplantation. In the USA, 17,105 kidney transplants took place in 2014. Of these, 11,570 grafts were obtained from deceased donors and 5535 from living donors. In India, deceased organ donation program is still in its infancy, largely restricted to big institutions and hampered by the lack of a national policy for organ recovery or allocation. However, in the last 3 years, the numbers of deceased donors have more than doubled. The deceased donation rate in 2013 was 0.26/million populations, and this has gone up to 0.36/million population in 2014.
India has approximately 180-200 kidney transplant centers and one-third of these are in the major metropolitan cities, most in the private sector. In the government-run tertiary care hospitals, maintenance dialysis, transplantation, and follow-up are conducted free of cost for the underprivileged section of the community. In the private system, there are two arrangements: One where transplantation is performed for a cost, which is nonprofit-oriented, and other where it is performed in corporate hospitals where the cost of transplantation and follow-up is high for the average Indian patient. In India, most of the KT relies on live donor transplantation; however, many states have established a strong cadaveric transplantation program, one such example is Tamil Nadu Cadaver Transplant Programme, which is the most efficient and effective. Many other nongovernment organizations (NGOs) have established organ sharing network, which promotes deceased donation program. The Foundation for Organ Transplantation and Education-Bangalore, Multi Organ Harvesting Aid Network, Narmada Kidney Foundation, Zonal Transplant Coordination Committee-Mumbai, Organ Retrieval Banking Organization-Delhi, and Delhi Organ Procurement Network and Transplant Education are some of the active groups.
Regulation of transplantation
Donor exploitation and substandard medical care to recipients of paid kidney donors, prevalent in India in the 1980s and 1990s, prompted the Indian parliament to enact a law "Transplantation of Human Organs Act (THOA)" in 1995 to prevent organ exploitation and to facilitate organ donation after death, including brainstem death. However, the experience over the years proved that commerce was neither fully wiped out nor did the Act give a nationwide push to organ donation after brain death. Realizing this, the government has further amended the Act (2011) and framed certain legislation. While the Act was passed last year, the rules are still being framed for its implementation. Additional clauses of importance in the act include the following:
- It expands the definition of "near relative." Besides those previously defined-father, mother, brother, sister, siblings, and spouse, it now also includes the grandfather, grandmother, grandson, and granddaughter as near relatives
- It is mandatory for the intensive care unit or treating medical staff to request the relatives of brain-dead patients' permission for organ donation
- It makes possible for a surgeon or a physician and an anesthetist or an intensivist to be included in the medical board in the event of nonavailability of a neurosurgeon or a neurologist for certification of brain death
- It regulates the transplantation of organs for foreign nationals
- It prevents the exploitation of minors for organ donation.
- It provides for swap donations of organs
- It recommends the formation of a committee in each state to advise the appropriate authorities of the state in matters related to organ donation and transplantation
- It recommends the establishment of a National Human Organs and Tissues Removal and Storage Network and provides for the development and maintenance of a national registry of the recipients of human organ transplants
- It is compulsory to appoint a "transplant coordinator" in all hospitals registered for organ retrieval and transplantation to help with counseling of relatives in the event of brain death
- It suggests enhancing the penalties provided under the Act for commerce up to Rs. 20 million from the present Rs. 20,000.
Type of donors
There are two types of transplant donors:
A kidney that comes from a blood relative donors, such as a parent, siblings (brother or sister), and children over 18 years of age, have always been a better option. Recently, THOA act expands the definition of 'near relative' as already mentioned above. Kidney paired donation (KPD) also known as a "kidney swap" is an innovative twist on efforts aimed at increasing the live donor pool and prevent commercial transplantation by giving people who are unable to receive a kidney (due to human leukocyte antigen-incompatible or ABO incompatibility) from a loved one or friend, the opportunity to receive a kidney through an exchange between incompatible donor-recipient pairs [Figure 1]. Although KPD was underutilized in India, recently, KPD transplantation has been performed more frequently.,
|Figure 1: Kidney paired donation exchange between incompatible donor-recipient pairs|
Click here to view
Regulation of live donor transplantation
An application should be submitted to grant approval for removal and transplantation of a human organ, to the concerned "Authorisation Committee."
- There shall be one State level Authorization Committee, and additional Authorization Committees may be set up at various levels as per norms, namely:
- Authorization Committee should be hospital-based in cities if the numbers of transplants exceed 25 in a year at the respective transplantation centers
- If the number of organ transplants in a hospital is <25 in a year, then the State or District level Authorization Committee would grant approval (s)
- When the donor is unrelated and if donor and/or recipient belong to a State, other than the State where the transplantation is proposed to be undertaken, "No Objection Certificate" from the State of domicile of donor and/or recipient shall be required
- Where the proposed transplant is among near relatives, the concerned competent authority shall evaluate:
- Results of tissue typing and other basic tests
- Documentary evidence of relationship and documentary evidence of identity and residence of the proposed donor and family photograph depicting the proposed donor and the proposed recipient.
A deceased donor transplant (Cadaveric) is a transplant where the donated kidney comes from a person who has died (concept of brain death). Brain death is defined as the irreversible loss of all functions of the brain, including the brainstem. The three essential findings in brain death are coma, the absence of brainstem reflexes, and apnea.
• There are several classifications of kidneys that come from deceased donors:
- Standard criteria donor: Kidney that comes from a deceased donor under the age of 60 years
- Extended criteria donor kidneys: Kidney that comes from a deceased donor having age over 60 or >50 years with two or more risk factors such as donor has a history of high blood pressure, donor died due to stroke or has some kidney damage
- Donation after cardiac death donors: These types of donors are classified into controlled and uncontrolled categories. A controlled donor who suffers cardiac arrest after withdrawal of support or after brain death. Uncontrolled donor is the one those who is deceased on arrival to the hospital or who has a failed cardiopulmonary resuscitation
- High social risk donors: Donor is having a higher risk for transmission of infectious disease.
Regulation of cadaver transplantation
- The Central Government and the State Governments, as the case may be, by notification, shall constitute an Advisory Committee for 2 years to aid and advise the appropriate authority to discharge its functions
- Brain-death certification is made by a committee of four members which includes two registered medical practitioners (RMPs) nominated by appropriate authority, one neurologist or neurosurgeon, and the treating RMPs of the deceased person. In the absence of neurologist or neurosurgeon, any surgeon or physician, and anesthetist or intensivist, nominated by Medical Administrator Incharge and approved by the appropriate authority can sign the brain declaration certificate.
Kidney transplantation surgery
Kidney transplantation has traditionally been performed by open surgery, but recently, a minimally invasive laparoscopic approach with robotic assistance has been described., There is a strong rationale for utilizing minimally invasive surgery (MIS) in the ESRD patients. MIS (with robotic assistance) led to smaller incision, lesser surgical infections and technical complications, minimum blood loss and decreased postoperative pain, shorter hospital stay and convalescence period, and better cosmesis.
- Open donor nephrectomy: Nephrectomy is the surgical removal of a kidney. Open nephrectomy is rarely required but is also performed under general anesthesia
- Laparoscopic donor nephrectomy: Laparoscopic surgery involves the use of a laparoscope (wand-like camera) that is passed through a series of small incisions or "ports" in the abdominal wall. It is used to view the abdominal cavity and remove the kidney through a small incision. The procedure is performed under general anesthesia
- Warm and cold ischemic time: The quality of the kidney, immediately before transplantation, has a major impact on long-term graft function. "Warm ischemia" is a term used to describe ischemia of cells and tissues under normothermic conditions. Whereas "Cold ischemia" is a term used to describe the time during organ transplantation begins when the organ is cooled with a cold perfusion solution after organ procurement surgery and ends after the tissue reaches physiological temperature during implantation procedures. Prolonged cold ischemia time is associated with incrementally higher risk of delayed graft function and poorer allograft survival, particularly when cold ischemia time exceeds 24 h
- Transplantation procedure: Traditionally, the right iliac fossa is the standard fossa for KT, and the left iliac fossa is the preferred site for simultaneous kidney-pancreas transplantation. The ischemic time of the graft should shorten as long as possible, and temperature should be maintained between 1°C and 4°C. KT may be accompanied by multiorgan transplantation. In such situations, usually the more important transplantation (heart, lung, liver, pancreas, or small bowel) should be performed first. The detailed surgical procedure is beyond the scope of this article; details may be accessed in the book, "Comprehensive Clinical Nephrology" by Feehally et al.
Challenges faced by medical facilities during transplantation program
Identified obstructions to a functional kidney transplant program in developing countries such as India include:
- Lack of awareness: Lack of organ donation awareness in India is a major barrier for deceased donation. Socioeconomic factors, educational status, and language barrier affect the functioning of the transplantation program. One of our studies revealed that 3.3% of subjects with renal impairment were aware of their disease
- Sociocultural factors: In many cultures in the developing world, reverence of the dead is deep rooted, and several countries do not permit autopsies and thus do not have cadaveric transplant edicts. India enacted its own edict in 1995 and prohibit commercialized donation of organs and to facilitate organ donation after death, including brain stem death. The donors are often exploited, and previous studies have revealed that 75% of commercial kidney donors remain in debt, 90% reported deterioration in their health, and about 80% would not recommend donation to others if asked
- Immunosuppression: High cost of immunosuppressive agents and antibodies use for induction and treatment of rejection are often unaffordable for most patients, resulting in poorer graft survival rates.
Policy and guidelines
- The absence of a renal registry to generate data for policy formulation. Most of the estimates are based on information derived from the few functional dialysis units and severely underestimate the gravity of the problem.
- The absence of well-formulated health policies and guidelines by the government.
- The absence of effective national health insurance programs that includes patients with ESRD.
- Lack of basic and essential medical infrastructure in most of the hospitals.
- The absence of adequately trained and motivated staff to run the renal replacement programs. Many of the trained personnel also emigrate to better-paying jobs in the developed world; it has been reported that more than 20% of Indian nephrologists have emigrated to the developed countries.
- The absence of meaningful research in the tertiary health units.
- Lack of cooperation within the various units.
- Poor maintenance dialysis programs: Many centers are restricted to urban areas and have few machines, which are often poorly maintained and run by inadequately trained staff. Many do not follow the prescribed guidelines and protocols for running these units.
- Infections: In the developing world, particularly in the tropics, the incidence of infection is much higher.
Barriers to deceased donor transplantation
Lack of awareness of brain-death concept, lack of organ donation awareness, low number of cadaver renal transplant centers with inadequate infrastructure, and personnel are the main barriers to deceased donor transplantation in India.
Future recommendations for a successful transplantation program
Although no one country in the world generates sufficient organs from the available sources to meet the needs of their citizens, deceased donor transplantation can bridge the ever widening gap between availability and demand of organs for transplantation. Combined greater efforts of members of the health ministry, NGOs, and private and government medical college hospitals in the state can improve the functioning of the program. Recently, the National Kidney Foundation launched the Big Ask/The Big Give initiative to help better improve the lives of those with kidney disease through living donation. The following recommendations should be commencement for a successful transplantation program:
- Improve the socioeconomic status: Improvement in literacy, sanitation, and establishment of functional health program for better socioeconomic status.
- Implementation of ESRD and transplantation registries: The enactment of a solid organ transplant edict by the countries yet to do this is also essential as is the development of renal registries to enable more effective planning.
- We need to establish a transparent, independent, and functional national kidney foundation to serve the interests of the patients and to act as a unified group presenting their views to the government when the need arises.
- Implementation of guidelines concerning (a) evaluation of donor and recipient, (b) diagnostic and therapeutic procedures after transplantation, and (c) long-term follow-up procedures for donor and recipient.
- Newer techniques to reduce infections: There should be a continuous training to enhance the skills to reduce morbidity and mortality. Use of newer techniques in kidney transplant surgery may help to minimize postoperative recovery time and hospitalization.
- Commencement of national health insurance covering RRT: The majority of the patients cannot afford a transplant surgery due to financial constraints, and there being a lack of a national health insurance scheme. Scheme such as insurance coverage of RRT may help in mitigation of financial constraints.
- Public awareness programs focusing on the causes, prevention, and management of kidney disease must be encouraged.
- Greater efforts of trained transplant coordinator and nurse can empower the transplant program: The hospitals should be advised to set up a counseling service for individuals involved in organ transplant.
- The high cost of immunosuppression remains a major problem: Availability of immunosuppressive medications at affordable prices and government subsidies if possible, should be one of the focuses of such a kidney foundation. A common strategy should be adopted to reduce the cost of immunosuppression (i.e. Use of agents such as ketoconazole and diltiazem which inhibit calcineurin inhibitor metabolism).
- Transplant legislation should be mandatory: Transplant legislation should be developed by each country or jurisdiction for governing the recovery of organs from deceased and living donors and the practice of transplantation, consistent with international standards.
- Enforcement of deceased donor transplantation program: Deceased donation should be performed with altruistic motives and in a charitable manner. Cadaver renal transplantation involves declaring brain death, seeking permission from the relatives, retrieval of the organs, storage of organs, transport to the recipient's hospital, and ultimately transplantation. Future studies should focus on how to safely, ethically, and effectively use social networking sites to inform potential donors and potentially expand live and cadaveric kidney donation.
- Organ sharing network: It has worked on the principle that all organs should be utilized and not be wasted. A functional network for organ sharing exists only in a few states in India, at present. When the National Organ Transplantation Programme comes to existence in India, there will be a nationwide organ sharing network and utilization of donor organs optimally.
- National KPD program: To increase live related donor pool, transplant centers should work together toward a national KPD program and frame a uniform acceptable allocation policy. Future strategies will include regional, national, international exchanges, list exchange, three-way, domino chain, and nonsimultaneous KT.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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