CME INDIA Presentation by Dr. Mahadev Desai, Sr. Physician, Ahmedabad & Dr. Pranav Kharod, Sr. Neurophysician, Ahmedabad.

Peeping into the past

• Death in general, is defined as “Complete & Irreversible cessation of spontaneous Cardiac and Respiratory functions.
• In 1968, Harvard Medical School, for the first-time defined Brain Death as “apneic coma and absence of elicitable Brain Stem reflexes for a period of 24 hours as confirmed by an EEG.”
• In 1959, at the 23rd International Neurological Meeting, P. Mollaret and M. Goulon gave the first description of 23 patients with a pathological state they then called “coma de passe” (stage beyond coma).
• In 1981, UDDA (Universal Definition of Death Act) act by USA defined Death:
  • Irreversible cessation of circulatory and pulmonary functions or
  • Irreversible cessation of all functions of the whole brain, including the brain stem death.
• Declaration of Death by Brain Stem Death criteria has been given a legal recognition in India only in context of Transplantation of Human Organs Act, 1994 (THOA).
• Brain Stem Death criteria has revolutionized the concept of organ donation after death.

How many Organs and Tissues can be retrieved after Brain Death?

Brain Death: Important issues

• Aetiology & Pathophysiological mechanisms
• Brain Death in Indian context
• Determination of Brain Death
• Documentation of Brain Death

Aetiology and Mechanism of Brain Death

Loss of Brain Functions

Why do we need to diagnose Brain Death?

• Brain Death is the principal requisite for Organ donations for transplantation.
• Organs retrieved at the stage of Brain Death saves far more numbers of organs than after Cardiopulmonary Death because of rapid molecular changes which follow the Cardiopulmonary Death
• Decision to withdraw life support based on the concept of Brain Death may be difficult for many Caregivers and Family members.
• Compassionate and Skilful communication is very important to help relatives in making the decision.

Brain Death: Indian Context

• In India, Section 46 of IPC states, “the word Death denotes death of a human being unless the contrary appears from the context.”
• Declaration of Death by Brain Stem Death criteria has been given a legal recognition in India only in context of Transplantation of Human Organs Act, 1994(THOA). THOTA clearly states that the request for Organ donation must be made only after certification of Brain Stem Death.
• In 2011 the act was amended and renamed as Transplantation of Human Organs and Tissues Act (THOTA) which came in to force in 2014. THOTA clearly states that the request for Organ donation must be made only after certification of Brain Stem Death.
• The Union Government has passed the act and provided the framework, but all the States have not accepted uniformly.
• Kerala was the first state in India to adopt a standard operating procedure (SOP) for determining brain stem death.
• Certification of Brain Death is given as per the Form 10 of THOTA rules.
• NOTTO (National Organ & Tissue Transplant Organization) is the nodal agency and trains Transplant Coordinators for smooth and transparent functioning of the process.
• Any Hospital which requires recognition as Transplantation Hospital or Organ Retrieval Centre Team must have an Authorized Medical Examination Board with Names of Doctors empanelled.
• Team of 4 Medical Experts required to Certify Brain Death must include:
  • Medical Administrator In charge of Hospital
  • Authorized Specialist*
  • Authorized* Neurophysician / Neurosurgeon
  • Registered Medical Practitioner (RMP) treating the case.
• Amendments in THOTA (2014) have allowed selection of a Surgeon/Physician and an Anaesthetist/Intensivist, in the event of non-availability of Experts in the above list respectively.

Determination of Brain Death

Process for determining Brain Death includes 5 components:

1. Prerequisites

• Cause of Brain injury is known.
• Irreversibility of the Brain injury is certain.
• Neurological signs of functions of Brain including Brain Stem are absent.
• Eliminating medical conditions possibly complicating clinical assessments:
  • Severe Acidosis / Alkalemia.
  • Body temperature irregularities.
  • Drug intoxication and Poisoning.
  • Neuromuscular blockade.
  • Locked-in syndrome.

3. Apnoea Testing

• Objective: to demonstrate absence of respiratory control reflexes in brainstem on physiologic stimulation to breathing.
• Stimulus: rapid ↑ in the PaCO2 to > 60 mm Hg (or a 20 mm Hg ↑ over baseline).
• Outcome: Apnoea test positive means no spontaneous respiratory efforts in response to hypercapnic / acidotic stimulation.
• Complications: hypoxemia, hypotension, acidosis, hypercapnia, increased intracranial pressure, pulmonary hypertension, and cardiac arrhythmias.
• Apnoea Testing: Prerequisites
  • Normotensive (SBP>100 mm Hg).
  • Euvolemia: positive fluid balance in previous 6 hours.
  • Normothermia (Body temperature >36.50 C or 97.70 F).
  • Normal PCO2 (Option: Arterial PCO2 ≥ 𝟒𝟎 𝐦𝐦 𝐇𝐠).
  • Normal PO2 (Option: Preoxygenate with 100% O2 to keep PO2 >200 mm Hg).

4. Ancillary testing

• Laboratory tests
• EEG
• Neuroimaging: CT / MRI
• DSA / SPECT / Angiography
• Doppler USG

Procedure for Documentation of Brain Death

• All the prescribed tests are required to be repeated, after minimum interval of 6 hours.
  • “To ensure that there has been no observer error” and persistence of the clinical state can be documented.
  • In the case of Anoxic brain damage, this period should be extended to 12 hours.
• To ensure that all data are entered in Form 10 of the THOTA Rules and signed with dates by All 4 Doctors.
• After the completion of second apnoea test, the patient is declared brain stem dead.
• Inform the next kin of the results.

5. Documentation of Brain Death

• Documentation should include (regulations may vary by States and Countries):

Disclaimer

• Brain Death is a subject, full of controversies and disagreements from Clinical, Religious, Legal and Policy perspectives among Countries and States.
• Please refer to prevailing guidelines of the local area. Present discussion focuses on various clinical aspects of Brain Death and sensitize Medical Fraternity about Organ Donation

Link (This presentation is based on a presentation of Medflix)

• See “All you need to know about brain death.“

Suggested Readings:

1. Sung G. Brain Death/Death by Neurological Criteria: International Standardization and the World Brain Death Project. Crit Care Clin. 2023 Jan;39(1):215-219. doi: 10.1016/j.ccc.2022.08.005. Epub 2022 Oct 9. PMID: 36333032.
2. Truog RD. The Uncertain Future of the Determination of Brain Death. JAMA. 2023 Feb 7. doi: 10.1001/jama.2023.1472. Epub ahead of print. PMID: 36749767.
3. William Spears, Asim Mian & David Greer .Brain death: a clinical overview,Journal of Intensive Care volume 10, Article number: 16 (2022)
4. https://radiopaedia.org/articles/brain-death-2
5. Dhanwate AD. Brainstem death: A comprehensive review in Indian perspective. Indian J Crit Care Med. 2014 Sep;18(9):596-605. doi: 10.4103/0972-5229.140151. PMID: 25249744; PMCID: PMC4166875.
6. Gracious N, Jose VR. Certification of brain stem death in India: Medico-Legal perspectives. Amrita J Med [serial online] 2020 [cited 2023 Feb 28];16:71-6. Available from: https://ajmonline.org.in/text.asp?2020/16/2/71/292422

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