Demography of brain stem death and factors leading to successful consent for organ donation

Abstract

Background

There is a widening gap between the patients requiring transplants in proportion to the availability of organs donated. After brain stem death (BSD), counselling for consent is mandatory and if successful, and viable organs are recovered. A low consent rate for donation results in failed donation in a number of potential donors. Many potential donors fail to make a donation due to various social and familial reasons resulting in a poor consent rate. The aim of this study was to identify the variables that lead to donation denials.

Methods

This retrospective study, carried out from Jan 2009 to Dec 2021 at a tertiary centre with an active transplant and donation programme, analysed BSDs and their counselling outcomes.

Results

A total of 10998 patients were admitted to the intensive care unit, with 2401 (21.8%) deaths. BSD was diagnosed in 8.5% of all deaths, with donor suitability seen in 77.1% (n = 158) cases. After counselling, 55.7% families consented for organ donation. Amongst the families declining consent, most had multiple reasons. The commonest reasons were a difference of opinion among the family members (70%) and unclarity of BSD concept (44.3%). Other reasons included fear of mutilation, religious beliefs, and hope of a miracle.

Conclusion

As most reasons of denial are social and related to public awareness, a meticulous transplant program with enthusiastic coordinators coupled with augmentation of public awareness, responsible media reporting, and improved doctor–patient–relative communication would result in enhanced rates of consent.

Introduction

With every passing year, the gap between transplant recipients and organ availability widens. While donation from a living donor is an option, a number of patients do not have this luxury. Donation after brain death (DBD) presents an option for limiting this gap. Viable organs recovered after brain stem death (BSD) can save lives with deceased donor transplantation. Enhanced DBD rates may be a panacea for most ills that plague a transplant program. BSD is diagnosed after demonstration of irreversible loss of consciousness, apnoea, and absence of brain stem reflexes.¹

Although DBD is the largest source for organs for transplantation, a large number of potential donors fail to donate. Consent for DBD is a problem. Few countries, such as Spain and Croatia, boast of donation rates of 48 and 41.2 donors per million, respectively, but most countries have discouraging rates. Studies from developed countries such as the United Kingdom reveal a denial rate of 41%.2, 3, 4, 5 However, donation targets continue to evolve, and countries aim to achieve a conversion rate of 75%.⁶

DBD is rare in India. In a country with an age-standardised mortality rate (per 100,000) of 20.2 and 40.0 due to chronic liver disease (CLD)⁷ and chronic kidney disease (CKD),⁸ respectively, it is disheartening that donation rates stand at 0.34 per million.⁹ The Government of India has provided for regulation of the transplantation process in the Transplantation of Human Organs Act (THOA) 1994. Further amendments elucidate the rules pertaining to diagnosis of BSD and legal procedures to be followed in living as well as deceased donation.¹⁰

BSD program

The management of BSD at our centre is strictly based on published protocol.¹¹ There are salient features about BSD that are legally important and deserve a mention. BSD is certified by the state medical authority–approved BSD committee in accordance with the THOA Rules 2014. The BSD team of the hospital comprises of four people, namely (a) medical administrator in charge, (b) intensivist/anaesthesiologist, (c) neurologist/physician/neurosurgeon/Surgeon, and (d) medical officer treating the patient.¹²

Pre-requisites to apnoea testing

BSD testing is done for all patients with an established cause of coma (persisting without any sedation), who have clinical and radiological evidence of brain damage and require mechanical ventilation (in absence of muscle relaxants) in absence of confounding factors. A detailed neurological examination to look for absent pupillary reflex, absent dolls’ eye movements, negative cold caloric test, absent corneal reflex, and absence of gag or cough reflex is carried out.¹¹ Apnoea test is the core of BSD testing dependent on absence of respiratory drive in the presence rising CO₂. The evidence-based guidelines are followed for the conduct of the same.^13,14 The diagnosis is confirmed after 06 h with repeat testing to obviate any observer bias.

Although organ donation is majorly limited due to religious beliefs, but factors such as illiteracy, difference of opinion among family members, misunderstanding BSD, and patient care concerns also play important roles.¹⁵ Understanding these factors may help in better counselling and improve the organ donation rates. Most refusals appear to be due to public unawareness. In most private hospitals, donor maintenance costs (after consent) are borne by the recipient, but in a government hospital (as ours), this may not be the issue as the care is provided by the state. We carried out this study to understand the demography of BSD in a government hospital and the factors that govern a success in obtaining consent from relatives after BSD.

Materials and methods

This study was carried out at a tertiary care centre in North India. Data pertaining to all patients (admitted to the intensive care unit (ICU) and 10-bedded long-term acute care (LTAC) ward from Jan 2009 to Dec 2021) were extracted from the local database. Approval to conduct the study was obtained from the Institutional Ethics Committee. All good clinical practice guidelines as per Declaration of Helsinki were followed during the study.

Our hospital's BSD unit has a transplant coordinator in addition to the medical professionals deemed mandatory by the THOA act. On suspicion of BSD, the brain death certification committee is activated for the diagnosis of BSD. Every BSD is documented, and records are maintained in the local database. On confirmation of BSD, the transplant coordinator is informed and is responsible for documentation of the proceedings (on a central registry of the hospital). The trained transplant coordinators counsel the relatives in a counselling room and approach the topic in a phased manner. After the second BSD testing, transplant coordinators approach the family (usually the next of kin (NOK) along with another senior family member) for possible organ donation. The discussion entails the request for donation, addressing the relatives' concerns and the data of organ donation of our hospital and our success stories. The concept and irreversibility of BSD is explained. The transplant coordinator also coordinates the donation process if consented to. Informed written consent from the NOK is taken prior to the recovery of organs. Parameters such as age, sex, diagnosis, date and cause of death, ventilatory requirement, haemodynamic parameters, requirement of inotropes, and haematological and biochemical profile of patients are noted. BSD patients with advanced age (>80 yrs), sepsis (diagnosed by culture positivity or raised procalcitonin), malignancy, refractory shock, viral infections such as hepatitis B virus, hepatitis C virus, and HIV, and post–cardiac arrest status are excluded from counselling. If the donation was refused, the reasons for refusal are documented in the database.

The data regarding BSD were extracted from the local database. The process of counselling and other demographic parameters were recorded. We aimed to retrospectively study the pattern of consent after BSD (from 2009 to 2021) and analyse the reasons for denial. SPSS 16.0 was used for analysis.

Results

A total of 10,998 patients were admitted in the ICU and LTAC wards, with 3750 (34.1%) being neurology/neurosurgery patients and 7248 (65.9%) patients with other diagnoses. Mechanical ventilation was required in 3772 (34.3%) patients, and 2401 (21.8%) patients died in the ICU or LTAC ward. Amongst patients admitted with a neurology/neurosurgical diagnosis (n = 3750), 595 (15.9%) died, whereas 1806 (24.9%) patients died after being admitted with other diagnosis. The basic demographic profile is given in Table 1. Of the total admissions, BSD testing was done in 225 (2.1%) patients. A total of 430 apnoea tests were carried out and were negative in 20 patients (09 had spontaneous ventilation during the testing, and in 11 patients, the CO₂ levels did not rise during the test). On the basis of the apnoea tests, 205 BSDs were diagnosed (1.9% of total admissions and 8.5% of all deaths). Among patients admitted for neurology or neurosurgery care, 168 BSD were diagnosed (4.5% of admissions and 28.2% of deaths) as compared to 37 BSD in non-neurology/neurosurgery patients (0.5% of admissions and 2.1% of deaths).

Table 1.

Patients’ profile.

Total admissions (ICU/LTAC)	10,998
Mechanical ventilation	3772 (34.3%)
Death	2401 (21.8%)
BSD testing	225 (2.1% of admissions)
Positive BSD	205 (1.9% of admissions and 8.5% of deaths)

Abreviations: BSD, brain stem death; ICU, intensive care unit; LTAC, long-term acute care.

Of the 205 BSD patients, 127 (61.9%) were males, and the average age was 44.3 ± 18.5 yrs. The commonest cause of death was head injury (n = 62, 30.2%). Brain stem dysfunction was noted in 62 (30.2%) patients, with hypotension being the commonest manifestation (23.9%). Hypertension and diabetes insipidus were seen in 2.4% and 8.3% of BSD patients, respectively. Details of BSD patients are given in Table 2. Of all BSD patients (n = 205), 77.1% (n = 158) were suitable for organ donation. Sepsis (n = 20, 42.6%) and malignancy (n = 17, 36.1%) were the commonest causes for unsuitability of a potential organ donor. The other causes of unsuitability were advanced age (n = 03, 6.4%), cardiac arrest (n = 04, 8.5%), hepatitis B surface antigen (HBsAg) positivity (n = 01, 0.6%), and refractory hypotension (n = 02, 4.3%). Outcome of BSD is illustrated in Fig. 1.

Table 2.

Details of brain stem deaths.

Positive BSD	205
Males	127 (61.9%)
Age	44.3 + 18.5 yrs
Head Injury	62 (30.2%)
Intracerebral haemorrhage	49 (23.9%)
Sub arachnoid haemorrhage	34 (16.6%)
Sepsis	24 (11.7%)
Intracranial malignancies	23 (11.2%)
Cerebrovascular accidents	09 (4.4%)
Subdural haematoma	02 (0.9%)
Others	02 (0.9%)
Suitable for donation	158 (77.1%)
Consent to donation	88

Abbreviation: BSD, brain stem death.

Fig. 1.

Outcome of brain stem death with respect to organ donation success.

Counselling was done for 158 patients, and 88 (55.7%) patients’ relatives consented for organ donation. Organ donation was carried out in 79.5% (n = 70) patients, whereas in 18 (20.5%) patients, it had to be abandoned. The causes for unsuccessful procurement were cardiac arrest prior to donation (n = 10), development of sepsis (n = 04), medicolegal issues (n = 02), and diagnosis of CLD with CKD (n = 02).

The 70 patients whose organs could be retrieved resulted in a donation of 69 livers (01 patient had CLD), 126 kidneys (06 patients had CKD, and one patient was a renal transplant recipient), and 140 cornea. Five hearts and 35 valves could also be retrieved as 10 patients had cardiac dysfunction, 06 had coronary artery disease, and family members of 19 patients did not agree for heart donation.

Among the relatives who did not consent for organ donation (n = 70) a multitude of reasons were present. Most of the family members had more than one reason for denial of the request. The commonest reason was a difference of opinion among the family members towards donation (n = 49, 70%) followed by misunderstanding of the concept of BSD (n = 31, 44.3%). Fifty-five (78.5%) of all denials had one or both of the two reasons. Some of the other factors contributing to the denial included fear of mutilation of the body (37.1%), religious beliefs (18.6%), and a hope of a miracle (17.1%). During the early part of the decade, a negative publicity of organ trade was also an important reason for denial (7.1%). The complete list of reasons (for denial) is enumerated in Table 3. It was important that in 17 (24.3%) patients, one of the contributing factors was the suspicion of poor quality of patient care, which may be due to possible inadequate communication between patients’ relative and the healthcare providers during the time of admission.

Table 3.

Reasons for refusal.

	Our patients (n = 70)	Seth et al. (n = 21)16
Difference of Opinion within family	49 (70.0%)	08 (38.1%)
BSD concept not understood	31 (44.3%)	04 (19.1%)
Fear of criticism by society	26 (37.1%)	04 (19.1%)
Fear of mutilation	26 (37.1%)	04 (19.1%)
Quality of patient care	17 (24.3%)	04 (19.1%)
Religious beliefs	13 (18.6%)	01 (4.8%)
Hope for a miracle	12 (17.1%)	03 (14.3%)
Negative publicity (organ trade)	05 (7.1%)	03 (14.3%)
MLC concerns	05 (7.1%)	01 (4.8%)
Reincarnation belief	03 (4.3%)	02 (9.6%)
Not wanting to do for strangers	03 (4.3%)	01 (4.8%)
Wants a normal death	02 (2.9%)
Second opinion	01 (1.4%)

Abbreviations: BSD, brain stem death; MLC, Medico Legal Case.

Discussion

Organ donation, driven by acts of generosity by family members of potential donors, has made transplantation a lifesaving treatment, but the dismal numbers of consents to organ donation limits the impact of this therapeutic modality. There are numerous aspects in an organ donation program that may impact the success or failure of donation consent.

Our centre has a transplant program with active participation from intensive care specialists and transplant coordinators. Apnoea test is mandatory and is carried out on 02 occasions 06 h apart to diagnose BSD. The apnoea test requires strict compliance, without which complications such as hypotension and cardiac arrest may occur. Centres have reported a complication rate close to 26%.¹⁶ Common reasons that cause complications include inadequate pre-oxygenation and electrolyte abnormalities. During 430 apnoea tests done at our centre, only 04 (0.93%) complications were noted as strict pre-requisites (mandatory 10 min pre-oxygenation with 100% oxygen, correction of electrolyte abnormalities etc.) and were followed. Belsh et al. also reported a very low incidence of complications due to meticulous conduct of apnoea testing.¹⁷

A total of 225 patients were tested, out of which 205 (91.1%) were diagnosed brain dead after BSD testing. Males (n = 127, 61.9%) contributed predominantly to the cohort. The fact that most of the drivers are males in a male-dominated society could be the reason for a skewed sex distribution. The average age of the BSD patients was 44.3 ± 18.5 yrs. The common aetiologies reported, leading to brain death, have been head injuries, subarachnoid haemorrhage (SAH), intra-cerebral haemorrhage (ICH), and malignancies.¹⁸ In our study, the commonest aetiology was head injury (30.2%), followed by ICH (23.9%), SAH (16.6%), and intracranial malignancies (11.2%). Proximity to a national highway and busy traffic throughout the day may be the possible reasons for the high prevalence of head injuries in our patients.

Forty-seven BSDs (22.9%) were unsuitable for organ donation due to concurrent illness and were equally shared between active sepsis (n = 24, 51.1%) and malignancy (n = 23, 48.9%).

A total of 158 patients were found to be suitable for organ donation and were counselled by our team of transplant coordinators. Relatives of 88 patients (55.7%) consented for donation of organs. A conversion rate of more than 50% is a commendable performance for any transplant team as the best centres from India report conversion rates of 19–40%.^19,20 Internationally, even in developed countries, the conversion rates are estimated to be in the range of 42–68%.^5,21 In-house training program for transplant coordinators has been shown to enhance donation rates.²² We believe that the enhanced conversion rates in our transplant program stems from an organised transplant coordinator program, proper training of transplant coordinators, and an enthusiastic team of healthcare professionals. We also believe that the thought of helping soldiers of our country contributes as most of our clientele is associated with the Armed Forces.

However, relatives of 70 (44.3%) patients did not consent for organ donation. Contrary to popular belief, the most common reasons were not related to religion, and religious or reincarnation beliefs contributed to only 18.6% and 4.3%, respectively. The commonest reason for refusal was a difference of opinion regarding organ donation within the family, wherein one member (frequently the NOK) agreed but the rest of the family did not. Our country has very strict familial values, and on some occasions, the NOK is not the most important person making decisions, and thus counselling of the NOK alone may not result in successful donations. Recently, we have started a more inclusive counselling with more than just the NOK being in attendance. The rates have shown an improvement. Seth et al. also noted that among 21 refusals, relatives of 08 (38.1%) potential donors had a difference amongst themselves.¹⁸ Our study, as compared to Seth et al. (Table 3), shows that the rates of refusal due to the ill understanding of BSD concept (44.3% vs 38.1%), fear of criticism by the society (37.1% vs 19.1%), and fear of mutilation (37.1% vs 19.1%) are significantly higher. A possible reason may be due to a more focussed approach and an objective assessment of the counselling sessions by the transplant coordinators and more diligent feedback in case of a refusal, which is noted on a pre-printed form, with all options making it more likely to record multiple reasons. What is important to note is that the most common reasons for denial continue to remain the same in studies two decades apart.

It is also important to note that in both studies, quality of patient care (24.3% vs 19.1%) and negative publicity due organ trade (7.1% vs 14.3%) were quoted as one of the reasons. A perception that the patient has received poor quality of care is a major hindrance to post-BSD counselling. These situations are easily avoidable by improved doctor–patient–relative communication and frequent counselling. It is important to understand that a trust between the healthcare provider and the relatives is a cornerstone to the success of the counselling sessions, in case required.

Conclusion

Organ donation is a very noble act that gives a chance to patient with incurable illnesses. However, the growing disparity between the availability of organs and the patients on waiting list indicates that processes should be in place for optimal utilisation of organs from brain-dead patients. The most common reasons such as a difference of opinion in family, misunderstanding of the ‘BSD concept’, and fear of criticism by the society can be easily addressed by increasing public awareness and genuine counselling. A healthy and trusting doctor–patient–relative relationship would also help. It is noteworthy that most of these hindrances can be overcome by health education and enhancement of awareness about organ donation.

A meticulous transplant program with enthusiastic coordinators coupled with augmentation of public awareness, responsible media reporting, and improved doctor–patient–relative communication are sure to result in enhanced rates of consent for organ donation.

Patients/ Guardians/ Participants consent

Guardian/ NOK consent was obtained.

Ethical clearance

Institute/hospital ethical clearance certificate was obtained.

Source of support

None.

Disclosure of competing interest

The authors have none to declare.