Brain death

Meta-Analysis of Data from Trials of Machine Perfusion Technologies in Liver Transplantation Demonstrates Clinical Advantages of Hypothermic Oxygenated Machine Perfusion (HOPE), according to Bridge to Life Ltd.

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水曜日, 5月 1, 2024

CHICAGO, May 1, 2024 /PRNewswire/ -- Hypothermic oxygenated machine perfusion (HOPE) of livers awaiting transplantation provides significantly greater outcomes than normothermic machine perfusion (NMP) and ice-box static cold storage (SCS), according to a Cochrane review and meta-analysis of seven clinical trials. The analysis, Machine perfusion in liver transplantation; Cochrane review and meta-analysis, by Samuel James Tingle, MD, et al, Newcastle University, Translational and Clinical Research Institute, Newcastle, United Kingdom; Freeman Hospital, Institute of Transplantation, Newcastle, United Kingdom; Newcastle University, NIHR Blood and Transplant Research Unit, Newcastle, United Kingdom Newcastle University, Translational and Clinical Research Institute, Newcastle, United Kingdom, was shown today in a late-breaker session during The 2024 International Congress of the International Liver Transplantation Society (ILTS) in Houston, Texas.

Key Points: 
  • CHICAGO, May 1, 2024 /PRNewswire/ -- Hypothermic oxygenated machine perfusion (HOPE) of livers awaiting transplantation provides significantly greater outcomes than normothermic machine perfusion (NMP) and ice-box static cold storage (SCS), according to a Cochrane review and meta-analysis of seven clinical trials.
  • The analysis included seven randomized trials (1024 transplant recipients from 1301 randomized/included livers); four compared end-ischemic hypothermic oxygenated perfusion (HOPE) with SCS, and three compared normothermic machine perfusion (NMP) with SCS.
  • Machine perfusion (MP) is a novel method for organ graft preservation before transplantation.
  • In hypothermic oxygenated perfusion (HOPE), donor livers are perfused through the portal vein with a cold (4 °C), acellular, oxygenated fluid at low vascular pressures.

Brain Injury Expert Says Important Changes Still Needed to Law Defining Death Despite Reform Pause

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木曜日, 10月 26, 2023

The recently announced pause by the Uniform Law Commission, which is spearheading revisions, is disappointing, the expert notes, but should not permanently stall practical fixes to longstanding problems with the Death Act.

Key Points: 
  • The recently announced pause by the Uniform Law Commission, which is spearheading revisions, is disappointing, the expert notes, but should not permanently stall practical fixes to longstanding problems with the Death Act.
  • Lewis says her survey results showed that 34 organizations (83%) favored revisions to the Death Act.
  • Uniform Determination of Death Act, which defined death as either the irreversible cessation of all brain or cardiopulmonary functions.
  • However, such loss of hormone function is not needed to be declared dead by brain criteria using current medical standards.

New Guidance Issued on the Determination of Brain Death AAN, AAP, CNS and SCCM Develop Consensus Practice Guideline

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木曜日, 10月 12, 2023

MINNEAPOLIS, Oct. 11, 2023 /PRNewswire/ -- New guidance has been issued for clinicians on the determination of brain death, also known as death by neurologic criteria.

Key Points: 
  • MINNEAPOLIS, Oct. 11, 2023 /PRNewswire/ -- New guidance has been issued for clinicians on the determination of brain death, also known as death by neurologic criteria.
  • This guideline updates the 2010 AAN adult practice guidelines and the 2011 AAP/CNS/SCCM pediatric practice guidelines on the determination of brain death.
  • Because of a lack of high-quality evidence on the subject, the experts used an evidence-informed consensus process to develop the guideline.
  • The consensus practice guideline outlines the standardized procedure for trained clinicians to evaluate people for brain death.

NanoString Platforms Advance Groundbreaking Studies of Immune Response in Pig-to-Human Organ Transplants

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月曜日, 8月 21, 2023

The groundbreaking study featured in the August issue and an accompanying commentary of The Lancet medical journal produced fundamental new data on the first pig-to-human organ transplants.

Key Points: 
  • The groundbreaking study featured in the August issue and an accompanying commentary of The Lancet medical journal produced fundamental new data on the first pig-to-human organ transplants.
  • Scientists used the nCounter Human Organ Transplant Panel , a process NanoString developed with the Banff International Classification Consortium.
  • The GeoMx Digital Spatial Profiler was used next to isolate the immune response to specific regions of the kidney.
  • “We congratulate Dr. Loupy and his extended team on their findings and celebrate the on-going successful studies in humans.”

What happens when doctors don’t act as they should? And what's the ruling against neurosurgeon Charlie Teo?

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木曜日, 7月 13, 2023

After several years of controversy, and both praise and blame for his willingness to perform high-risk surgeries, neurosurgeon Charlie Teo has been subject to practice restrictions by a special committee of the Medical Council of New South Wales. So how does the process of restricting doctors’ medical practice work? And what did this mean for Teo?How are health practitioners regulated in Australia? Health practitioner regulators in Australia aren’t generally empowered to make punitive decisions about health professionals’ conduct.

Key Points: 


After several years of controversy, and both praise and blame for his willingness to perform high-risk surgeries, neurosurgeon Charlie Teo has been subject to practice restrictions by a special committee of the Medical Council of New South Wales. So how does the process of restricting doctors’ medical practice work? And what did this mean for Teo?

How are health practitioners regulated in Australia?

    • Health practitioner regulators in Australia aren’t generally empowered to make punitive decisions about health professionals’ conduct.
    • Instead, Australia’s health practitioner regulations (the so-called “national law”) require decision-makers to exercise their powers to protect patients.
    • As the Australian Health Practitioners Regulation Agency (AHPRA) acknowledges, requirements to protect the public may sometimes result in “a determination that is harsher on the practitioner than if punishment were the sole purpose”.

What happened in the Teo case?

    • In late 2022, proceedings commenced against Teo via two complaints by the New South Wales Health Care Complaints Commission (HCCC).
    • Tragically, neither patient regained consciousness after the operations and both patients died – one just ten days after.
    • The HCCC alleged Teo had engaged in two categories of this wrongdoing: conduct below the standard reasonably expected of a doctor of his training and experience, and unethical conduct.

What were the findings and consequences for Teo?

    • Though the committee is not legally bound to apply the rules of evidence applied in criminal courts, it decided, broadly for procedural fairness reasons, to receive and consider all of Teo’s unchallenged evidence.
    • In a decision of more than 100 pages, the committee found Teo guilty of unsatisfactory professional conduct.
    • Read more:
      Doctors may soon get official 'endorsements' to practise cosmetic surgery – but will that protect patients?

What about patient autonomy or clinical freedom?

    • Here, the committee had to balance the practitioner’s right to practise medicine against the paramount consideration of patient health and safety and against the patient’s right to exercise autonomy.
    • a surgeon does not have a licence to undertake any conceivable procedure even with the agreement or acquiescence of the patient.

Is medical regulation strict in Australia and NSW?

    • Many reviews and academic studies find the national law to be fair and appropriate, or not strict enough.
    • However, some scholars and representative groups including the Australian Medical Association (AMA) find some aspects are too strict and unsympathetic to practitioners.
    • But a potted history of NSW medical history showcases how successive medical scandals have tended to drive strong regulatory reform.

What next for Teo?


    Teo may appeal the orders of the committee to the NSW Civil and Administrative Tribunal or seek a review of the conditions. But as the conditions are not subject to an end date, it appears they will otherwise continue indefinitely.

    Read more:
    How can the health regulator better protect patients from sexual misconduct?

OrganOx Enrols First US Patient for Post-Approval Study

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火曜日, 1月 10, 2023

The PAS will collect data on the occurrence of biliary-related complications, subject survival and graft survival of 315 liver transplant patients transplanted using NMP on metra.

Key Points: 
  • The PAS will collect data on the occurrence of biliary-related complications, subject survival and graft survival of 315 liver transplant patients transplanted using NMP on metra.
  • Raffaelle Girlanda, MD successfully performed the transplant procedure after the donor liver was perfused for five hours using metra.
  • Thomas Fishbein, MD, Executive Director of MedStar Georgetown University Hospital, added: "Being able to transplant the first patient on the OrganOx PAS is a significant milestone for NMP in the US.
  • We are looking forward to enrolling more patients to the Study and helping to reduce the liver transplant waiting list."

Concerns About 'Brain Death' Discussed in Journal of American Physicians and Surgeons

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火曜日, 9月 13, 2022

The UDDA, established in 1981, defines brain death as"the irreversible cessation of all functions of the entirebrain, including the brain stem."

Key Points: 
  • The UDDA, established in 1981, defines brain death as"the irreversible cessation of all functions of the entirebrain, including the brain stem."
  • AAN guidelines permit the diagnosis of brain death to be established by bedside examination alone, without requiring an electroencephalogram (EEG) or cerebral blood flow studies.
  • These inconsistencies result in increasing public distrust of the determination of brain death, which permits the harvesting of vital organs.
  • The Journal of American Physicians and Surgeons is published by the Association of American Physicians and Surgeons (AAPS) , a national organization representing physicians in all specialties since 1943.

Successful Heart Xenotransplant Experiments at NYU Langone Set Protocol for Pig-to-Human Organ Transplantation

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火曜日, 7月 12, 2022

The first heart xenotransplant concluded on Sunday, June 19, 2022, and the second on Saturday, July 9, 2022.

Key Points: 
  • The first heart xenotransplant concluded on Sunday, June 19, 2022, and the second on Saturday, July 9, 2022.
  • Using a new infectious disease protocol, no presence of porcine cytomegalovirus (pCMV) was detected in either case.
  • We have included that additional screening in this heart transplant protocol to give the organ the best chance at long-term survival."
  • The infectious disease testing protocol developed at NYU Langone Health was led by Sapna Mehta, MD , director of the transplant infectious diseases program and clinical director of the NYU Langone Transplant Institute.

TransMedics Receives FDA PMA Approval of OCS™ DCD Heart Indication

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木曜日, 4月 28, 2022

The landmark approval stands to significantly expand the pool of eligible donor hearts in the United States and follows FDA PMA approval of the OCS Heart System for use with organs from donors after brain death (DBD) received in September 2021.

Key Points: 
  • The landmark approval stands to significantly expand the pool of eligible donor hearts in the United States and follows FDA PMA approval of the OCS Heart System for use with organs from donors after brain death (DBD) received in September 2021.
  • The OCS Heart System is now approved withthe extended clinical indication forex vivo reanimation, functional monitoring, and beating-heart preservation of donation-after-circulatory-death (DCD) hearts.This indication is based on the results of the OCS DCD Heart Trial and the associated Continued Access Protocol (CAP).
  • "The FDA's approval of the OCS for DCD donor hearts is the natural progression from the prior approval of the device for extended criteria brain dead donors, supported by the excellent results from the U.S. DCD trial," said Dr. Jacob Schroder, surgical director of heart transplantation at Duke University Medical Center and the principal investigator for the OCS DCD Heart Trial.
  • With OCS we will be able to expand access to this life saving therapy to more end-stage heart failure patients."

OrganOx receives FDA approval for its liver normothermic machine perfusion system

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月曜日, 12月 20, 2021

OXFORD, England, Dec. 20, 2021 /PRNewswire/ -- OrganOx, a world leader in normothermic machine perfusion (NMP), today announced that the U.S. Food and Drug Administration (FDA) has granted premarket approval (PMA) of its metra system.

Key Points: 
  • OXFORD, England, Dec. 20, 2021 /PRNewswire/ -- OrganOx, a world leader in normothermic machine perfusion (NMP), today announced that the U.S. Food and Drug Administration (FDA) has granted premarket approval (PMA) of its metra system.
  • The marketing approval includes both livers from donors after brain death (DBD) and livers from donors after circulatory death (DCD).
  • The OrganOx metra is the world's first fully automated NMP system to receive FDA approval for the preservation of donor livers prior to transplant.
  • Within the organ transplantation sector its mission is to save lives by making every donated organ count through the development of normothermic machine perfusion technology.