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Position Statements

Position Statements

Read our positions on important transplant issues! 

Note: Transplant is a rapidly advancing field and our statements are periodically revised.

Surgical Standards for Surgeons Performing Deceased Donor Organ Procurements for Transplantation

ASTS Standards and Quality Committee

Approved by the ASTS Executive Committee: April 2023

Because it is the first stage of the organ transplantation process, high quality organ procurement is essential to successful transplantation, and good stewardship of donor family wishes necessitates comprehensive professional training and application of the highest standards to those who procure organs, particularly in view of the increasing technical complexities of the procedure.

The intent of the following standards for the procurement of organs is to establish criteria by which transplant centers and organ procurement organizations (OPOs) can ensure that, in addition to meeting any applicable licensure or third-party payer requirements, individuals who procure deceased donor organs are appropriately trained to provide the highest quality organs possible from every deceased donor with consistency, safety and professionalism.

Criteria for Surgeons Performing Deceased Donor Procurements

  • A surgeon must have a US medical license or institutional license (form of restricted medical license to practice) and transplant training as outlined below:
    • A surgeon with a US medical license should:
      • Have completed an ASTS-accredited transplant fellowship with a total of 25 multi-organ procurements, including five (5) DCD procurements (Qualified Transplant Surgeon); or
      • Be in the process of completing an ASTS-accredited transplant fellowship and must have completed a total of at least 10 multi-organ procurements, including two (2) DCD procurements, with observation from a qualified procurement surgeon and approval from an attending surgeon(s) in his or her fellowship program; or
      • Have completed transplant training or organ procurement training in another format with a total of 25 multi-organ procurements (including five (5) DCD procurements) under the observation of a Qualified Transplant Surgeon, and obtain a letter of approval from that Qualified Transplant Surgeon. 
    • A surgeon with an institutional license, restricted medical license, or international degree should:
      • Have completed transplant training or organ procurement training in another format; and 
      • Have completed 25 multi-organ procurements (including five (5) DCD procurements) under the observation of a Qualified Transplant Surgeon; and
      • Provide documentation of review and approval from a Qualified Transplant Surgeon.
    • Regardless of age or experience, a surgeon who has not completed an organ procurement in the last six (6) years and is not a practicing transplant surgeon should only perform organ recovery in the presence of a Qualified Transplant Surgeon. Supervision of one procurement and approval prior to independent procurements is sufficient to perform independent recoveries.

 

Additional Recommendations

ASTS recommends that OPOs track the quality of the procurement services provided by those who procure organs for transplantation and that performance issues, including behavioral issues, be noted in the ACIN system and reported to the entity with which the procuring surgeon is affiliated. If poor performance leads to the loss of a potentially transplantable organ, a report must be filed with the Organ Procurement and Transplantation Network. A surgeon can lose transplant program or OPO privileges to perform donor recoveries if quality issues arise or if the surgeon fails to comply with an established code of conduct.

Procedural Standards for Deceased Donor Organ Recovery, Approved by the ASTS Council - January 2022

ASTS Statement on donor-derived cell-free DNA (dd-cf-DNA)

Approved by the ASTS Executive Committee on March 6, 2023

Definition of the Problem:

The goal of organ transplantation is to save lives and increase quality of life. Critical overarching strategic goals for the transplant community are to increase the number of patients receiving transplants, improve access to transplantation for all, and improve long term transplant outcomes. Improving long term transplant outcomes is central to achieving those strategic imperatives. However, despite enormous success in other phases of the transplant endeavor, dramatic improvements in long term allograft survival have proven elusive.  One of the key reasons for this may be that the transplant community continues to monitor allograft function utilizing legacy modalities that often have not changed in decades. For example, in the case of renal allograft function, clinicians still rely primarily on monitoring serum creatinine, urine protein, and donor specific antibody. The emergence of molecular diagnostic techniques has the potential to alter that paradigm and may allow significant improvements in long term allograft function. Our goal in commenting on this topic is to provide clarity for clinicians and advocate for access to these modalities as clinically appropriate for the patients we serve.

Read the full position statement here.

 

ASTS Statement on Thoracoabdominal Normothermic Regional Perfusion Donation after Circulatory Determination of Death

Drafted by the ASTS Ethics Advisory Committee, and approved by the ASTS Executive Committee on August 23, 2022

Definition of the problem

Thoracoabdominal normothermic regional perfusion for donation after circulatory determination of death (TA-NRP DCD) utilizes oxygenated machine perfusion for the preservation of abdominal and thoracic organs rather than standard cold perfusion.  After the donor has been pronounced and confirmed dead, and after waiting 2 to 5 minutes after the determination of circulatory death to ensure the decedent does not spontaneously resuscitate, the TA-NRP DCD procedure involves opening the chest, central cannulation, clamping of the brachiocephalic vessels and initiation of normothermic oxygenated perfusion to the organs that will be used for transplantation. The procurement proceeds in the same fashion as a brain-dead donor.

ASTS principles regarding the ethical acceptability of NRP-DCD procurement procedures

  • The ethical acceptability of DCD donation is based on 3 fundamental principles: respect for autonomy, nonmaleficence and beneficence.
  • Respect for autonomy requires that authorization is obtained for DCD donation as well as for any procedures done or medications administered for organ evaluation or preservation. In addition, the discussion about organ donation in the setting of DCD donation must occur after the decision to withdraw life-sustaining treatments has been made. Further, as is always the case, medical professionals attending to the patient and working with the family through end-of-life care and decisions must be separate and apart from those medical professionals who are part of the organ recovery or transplant team and process.
  • Nonmaleficence requires that harm to the donor is avoided. First and foremost, this requires that potential DCD donors are provided with the same level of comfort care measures as individuals who undergo withdrawal of life-sustaining treatments without consideration for organ donation. Second, it requires that the organ procurement procedure commences after the donor is dead so that the procedure itself does not cause death (i.e., the dead donor rule).
  • Death in DCD donation is determined by circulatory and respiratory criteria consistent with the legal definition of death in the Uniform Determination of Death Act, which has been adopted in all material respects by almost all states in the US. The UDDA states: “An individual who has sustained either (1) irreversible cessation of circulatory and respiratory functions, or (2) irreversible cessation of all functions of the entire brain, including the brain stem, is dead”. DCD donors are declared dead in accordance with the UDDA and following accepted medical standards by a medical provider who is not a part of the organ procurement team and using the hospital’s criteria for cardio-pulmonary death.
    • After the cessation of circulatory and respiratory function, a hands-off period is observed for irreversibility of circulatory death, during which there is an absence of auto-resuscitation and death is confirmed at the end of that period.
    • Circulatory death occurs when the heart and lungs have lost their ability to function within the organism and cannot contribute to the operation of the organism as a whole. Circulatory death is confirmed in a DCD donor after a hands-off period in which autoresuscitation does not occur. At that point, the donor is dead and the procurement team is allowed to proceed with organ procurement.
    • Ensuring that the donor is dead is essential to DCD donation because the procurement procedure occurs directly following confirmation of death.
  • Beneficence requires that risks are minimized and benefits are maximized in medical procedures. Because DCD donors are dead at the time of donation, they do not benefit from the procedure, but there is benefit to family members who hope that their loved one can help as many others as possible through organ donation. Moreover, increasing the likelihood of benefit to organ transplant recipients is an element of beneficence considering the donor-recipient dyad.
  • The ethical acceptability of TA-NRP DCD has been questioned because (1) the heart is re-perfused in the body, which some allege brings into question irreversibly, and (2) the brachiocephalic vessels are clamped before the initiation of NRP, which prevents reestablishment of flow to the brain but which some allege is a contributing cause to the death itself.
  • The ASTS supports the ethical acceptability of TA-NRP DCD because this procedure meets the ethical baseline for DCD organ donation as follows: following a family’s decision to cease all life-sustaining therapies for their loved one, authorization is obtained for TA-NRP donation as well as consent for ante-mortem interventions and medications in the same way as it is done for a standard DCD donor; nonmaleficence is fulfilled because the NRP procurement procedure does not start until the donor has been confirmed dead. Our analysis of the specific ethical concerns about TA-NRP DCD are as follows:
    • Perfusion of the organs in the body: This is not autoresuscitation or resuscitation of the donor. The donor is dead before the initiation of NRP. NRP is mechanically assisted regional perfusion and oxygenation of organs for transplantation.
    • Clamping the brachiocephalic vessels before the initiation of TA-NRP ensures that the brain is not reperfused. Circulatory death has already been determined under the UDDA and in accordance with accepted medical standards when the brachiocephalic vessels are clamped.
    • Reperfusing the heart in the body on NRP is no different that restarting the heart outside of the body with machine perfusion. While this is optically different, in both cases, the heart is restarted with artificial machine assistance for the purpose of organ donation in a person who died intending to donate their organs. The heart would not continue to function within the donor without ventilatory support so it is functioning only with mechanical assistance for the purposes of organ donation.

The ASTS hopes to engage the medical and lay community in open, transparent dialogue about TA-NRP DCD donation to maintain trust in organ donation and demonstrate our commitment to the organ donors who make transplantation possible and save the lives of our patients.

References

 

Statement about Dobbs v. Jackson Women's Health

Drafted by the ASTS Ethics Advisory Committee on July 1, 2022, and approved by the ASTS Executive Committee on July 5, 2022

The American Society of Transplant Surgeons is deeply concerned with the decision of the Supreme Court in Dobbs v. Jackson Women’s Health that overturns Roe v. Wade, allowing states to legislate the reproductive services that can be provided to women.  This decision impacts the sanctity of the patient-physician relationship, interferes with privacy in medical decision making, and will disproportionally impact already vulnerable members of our society.  The primary concerns of the ASTS about this ruling  are that:

  • Subjecting evidence based medical care to legislation sets a dangerous precedent. Physicians should be able to freely provide evidence based medical care to their patients without fear of prosecution.
  • Decisions about medical care should be private, protected, and between patients and their physicians without governmental interference. 
  • As a result of this ruling, access to safe, legal reproductive services will be restricted to those with adequate resources or favorable circumstances. Moreover, socially and economically disadvantaged individuals will be disproportionately impacted by legal restrictions to comprehensive reproductive care.
  • Pregnancy in some end stage organ disease and post-transplant patients can be high risk for pregnancy loss, maternal and fetal complications as well as graft rejection and loss. States with restrictive abortion laws will put these patient grafts and lives at risk.

The ASTS supports legislation that protects comprehensive reproductive health care that is evidence based and opposes legislation that interferes with decisions that should reside within the privacy of the patient-physician relationship. 

 

Joint Statement about COVID-19 Vaccination in Organ Transplant Candidates and Recipients

Issued by ASTS, the American Society of Transplantation (AST), and the International Society for Heart and Lung Transplantation (ISHLT) in January 2022.

Community spread of SARS-CoV-2 is waning in some parts of the world, especially in those areas with greater vaccine acceptance, while activity is increasing in other parts of the world due to a variety of factors, including highly transmissible variants and low rates of vaccination. Information about COVID-19 vaccine responses in transplantation is rapidly evolving. Because vaccines are critical to containing further spread of the pandemic, there has been interest in optimizing vaccine responses in vulnerable populations, including solid organ transplant (SOT) recipients. To date, we have learned the following:

  • Antibody responses to COVID-19 vaccines in transplant recipients are diminished compared with the general population. However,
    • The level of protective antibody has yet to be defined. Based on data derived from trials in the general population, there is an inverse correlation between the level of neutralizing antibody to SARS-CoV-2 spike protein and symptomatic disease. Additionally, the ability of some monoclonal antibodies against spike proteins to attenuate disease shows the protective nature of antibody. While this is true for populations, the individual antibody response remains unpredictable.
    • Three dose mRNA vaccination is associated with improved rates of serum neutralization against SARS-CoV-2 variants in transplant recipients versus 2-dose vaccination.
    • The post-vaccination antibody threshold for protection against severe COVID-19 is significantly lower than that required to prevent viral infection.
    • Determination of protective levels of antibody is confounded by the wide variety of antibody tests that are commercially available, with no direct means to compare results from the different tests.
  • The protective components of Cellular (T cell and NK T cells) and humoral responses (IgG/IgM vs IgA) may not be linked in individual SOT recipients; it is possible to have an active acquired or innate immune response in the absence of antibody and vice versa. However, the clinical consequence of this divergence is not known nor measurable.
  • Antibody testing is currently not recommended by the FDA due to the following considerations:
  1. Most commercially available tests do not examine neutralizing antibody to the spike protein receptor binding domain (RBD).
  2. Many commercially available tests are qualitative.
  3. The analytical cut-off values for antibody detection are not necessarily the same as clinically relevant values.
  4. There is no commonly agreed upon titer that has been defined as protective against SARS-CoV-2 infection.
  5. Cellular responses may occur in the absence of measurable antibody.
  6. However, failure to mount any detectable antibody response to the spike protein after vaccination is concerning for increased risk for COVID-19 acquisition, especially with more transmissible variants.
    Clinical effectiveness studies in SOT show an overall reduction in infections after 2-dose vaccination and an effectiveness of 59% (in a CDC study that combined the SOT and stem cell transplant population).
  • Moreover, breakthrough infections occur at greater rates and greater severity than in the general population.
  • While the level of immunosuppression, specifically the use of antiproliferative agents, has been implicated as a factor in poor antibody response after vaccination, there is no reliable guide for adjustment of immunosuppression in anticipation of vaccine responses. Current data suggest that providing a third dose of mRNA vaccine to SOT recipients that have previously received two doses of mRNA vaccine can increase antibody titers to SARS-CoV-2; in a recent, double-blind, randomized placebo-controlled trial, a third dose mRNA vaccine provided at an interval of two months after the second dose significantly increased antibody titers, neutralizing antibody, and cellular immune response to SARS-CoV-2 compared to third dose placebo. For individuals who have received a single dose of an adenovirus vector vaccine, a second vaccine dose with either the same vaccine or an mRNA vaccine is indicated for all individuals, including transplant candidates and recipients. It is unknown if a specific vaccine is preferable for this additional dose. Early data from the UK in healthy individuals suggests that using an mRNA vaccine may be preferred to additional adenoviral-vector vaccine doses though transplant-specific data is not available.
    The published data to date suggest that additional doses are safe and reasonably well-tolerated with no evidence of an increased risk of rejection attributable to vaccine.
  • Clinical effectiveness of expanded vaccine dosing is pending. There are insufficient data to recommend the use of antibody testing to guide decision-making about additional doses. The effect of additional vaccine doses for vector-based and other vaccines is not clear.
  • Many of the reports to date focus on kidney transplant recipients, but it does appear that other organ recipients experience similar responses to additional vaccine doses. Despite 3 doses of mRNA vaccine, there are still patients that have poor antibody responses and we do not know what interventions, if any, might be indicated. Whether altering the vaccine used for the additional dose (e.g. giving adenovirus vector following mRNA or vice versa) is unknown.

RECOMMENDATIONS:

  • We strongly recommend that all eligible children and adult transplant candidates and recipients be vaccinated with a COVID-19 vaccine that is approved or authorized in their jurisdiction.
    Whenever possible, vaccination should occur prior to transplantation (ideally with completion of vaccine series a minimum of 2 weeks prior to transplant).
  • We support the development of institutional policies regarding pre-transplant vaccination. We believe that this is in the best interest of the transplant candidate, optimizing their chances of getting through the perioperative and post-transplant periods without severe COVID-19 disease, especially at times of greater infection prevalence.
  • SOT recipients that have received 2-dose mRNA vaccine should also receive a third dose of mRNA vaccine to complete the primary series.
  • Further research is needed to clarify if additional doses of other vaccines, including adenoviral vector vaccines will provide similar benefit. At this time, patients who have received a single dose of adenovirus vector vaccine (typically Johnson &Johnson/Janssen) would benefit from a second dose of vaccine and data from immunocompetent hosts suggest that that an mRNA vaccine dose may offer benefits. Consequently, we recommend that mRNA vaccine be considered for transplant recipients that previously received an adenoviral vector vaccine. There are limited data to provide guidance regarding additional doses of COVID-19 vaccine for those who have received 2 doses of Astra Zeneca based adenovirus vaccine, however it is reasonable to provide 3rd doses for these individuals and mRNA vaccines can be used in this circumstance.
  • There are no data currently to support adjustment of immunosuppression in anticipation of additional doses of vaccination.
  • Antibody testing is not required prior to or after additional vaccine doses and is not currently recommended by the FDA.
  • However, individual physicians and patients may decide that antibody testing is desirable to discern the individual patient’s response to the vaccine antigen with a resultant discussion about the interpretation of the test results and the consequences/risks of acquiring COVID-19 infection. The discussion will need to include additional issues relevant to the patient, such as local prevalence of SARS-CoV-2 and its variants, personal situations relating to immunosuppression and transplant infections and the vaccination level in the household that may be pertinent.
  • It is strongly recommended that living donors be vaccinated with a minimum of two-doses of vaccine and boosters are encouraged. This is to minimize peri-operative risks for donor (and spread to the recipient if there is contact).
  • All eligible household and close contacts of SOT recipients should be vaccinated against SARS-CoV-2 to minimize risks to the recipient.
  • It is strongly recommended that all health care providers be vaccinated against SARS-CoV-2 to foster a safer environment for our patients and maintain a skilled workforce.
  • While COVID-19 variants continue to evolve and circulate in the community and the extent of protection is still unknown in transplant recipients, it is recommended that SOT candidates and recipients continue to adhere to protective measures including masking in public spaces, social distancing, frequent hand washing, and avoiding indoor crowds. These measures should be followed regardless of whether the patient has received additional doses of vaccine. Information about viral variants, vaccine effectiveness and perceived/real risk is changing rapidly and it is important to address the concerns of transplant recipients.
  • We recommend ongoing monitoring of the regulatory and health department websites to obtain up to date COVID-19 prevalence and vaccine updates.
  • We strongly encourage participation in clinical studies to determine the effects of additional doses or other strategies to improve vaccine responses.
  • We strongly urge funding agencies to invest in research evaluating vaccine immunogenicity, vaccine effectiveness, and strategies to enhance vaccine responses in vulnerable populations, including SOT candidates and recipients, who may fuel the perpetuation of the pandemic.

 

ASTS Position Statement on the Role of COVID-19 Vaccination for Transplant Candidates and Recipients

Drafted by the ASTS COVID-19 Strikeforce on October 8, 2021, and approved by the ASTS Executive Committee on October 18, 2021

The goal of organ transplantation is to improve the health of people with failing organs. The pandemic has been exceptionally challenging for transplant and organ failure patients because of their reduced ability to fight the disease. Lessons learned from the pandemic include that 1) acquisition of COVID-19 in transplant recipients is more lethal than in the general population, 2) COVID-19 disease is mitigated through vaccination, although not as efficiently as in the healthy population, and 3) vaccination is consistent with the routine transplant practice to identify and mitigate conditions known to put an individual recipient at risk.

There are many reasons for routine organ transplant candidate and recipient vaccinations. The obvious is to provide a mitigation of the acquisition of COVID-19 and death. Additionally, transplant candidates and recipients frequently interact with other at risk individuals in the clinic or hospital and if infected can serve as an infectious vector to them. Virtually every candidate for an organ transplant has recognized conditions that increases their risk for severe disease. Additionally, the severity of COVID-19 disease is exacerbated by surgical procedures and in those taking medications to suppress the immune system. “Healthy” transplant recipients taking baseline anti-rejection medications have been observed to have more severe COVID-19 disease. Therefore, “good medicine” is to mitigate against known risks, and vaccination is an effective tool that decreases the risk for the transplant candidate and recipient. Pre and post-transplant vaccination against a wide spectrum of diseases has been routine for years. The medications required for successful transplantation diminish antibody responses (compared to the general population) to vaccinations and COVID-19 is not an exception. Therefore, the ASTS continues to recommend routine vaccination for all organ recipients (with timely boosters) and for those on the waitlist (if possible within time limitations). This mandate is consistent with our pre-existing “routine standards of care” to mitigate known infectious disease prior to organ transplantation.

 

Statement of Principles for Organ Donation and Transplantation

Drafted and approved by the ASTS Council, April 12, 2021

The American Society of Transplant Surgeons advances the art and science of transplant surgery through patient care, research, education, and advocacy. We view ourselves as patient advocates first and foremost. Dedication to our patients motivates us in our patient care and research endeavors. That same dedication and focus has led us to state the foundational principles that guide our education and advocacy efforts.

  1. Our primary public policy objective is to develop and promote policies that increase access to transplantation for medically appropriate patients while maintaining the highest quality of care possible.
  2. ASTS supports efforts to identify and eliminate any Transplant Center processes or practices that allow discrimination based on race, gender, gender identification, religion, ethnic background, disability, or other factors.
  3. ASTS supports efforts to encourage the acceptance of organs at risk of discard through educational efforts, the identification and adoption of best practices, and implementation of evidence-based guidelines.
  4. ASTS urges policymakers to collaborate with the entire spectrum of organ donation and transplant stakeholders in developing or assessing policies that impact organ donation and transplantation.
  5. ASTS supports reducing burdensome and duplicative regulation of transplant services that adversely impact patient care. Our aim is to streamline regulatory oversight to reduce costs and improve quality.
  6. ASTS supports elimination of public display of transplant center ratings and certain performance assessment outcome metrics that compare transplant centers to one another. Such display disincentivizes the transplantation of usable organs at risk of discard and the transplantation of those candidates that are most vulnerable. Alternatively, we support performance metrics that motivate increasing the use of all transplantable organs and promote the transplantation of all patients who will benefit, including the most vulnerable candidates.
  7. ASTS believes that when regulatory standards change, the affected organizations should be given adequate time to comply with any new requirements and that an equitable process must be available for underperforming organizations to address their deficiencies and to demonstrate mitigating circumstances.
  8. Any decertification decisions with the potential to impact the availability of transplant organs or access to transplant services should be made with care and due process and include a transition plan that ensures uninterrupted access to transplantation in the affected service areas.
  9. Any decision to accept an organ for transplantation is highly complex, involving multiple clinical considerations, and should be made by transplant teams based on the best interests of the potential organ recipient without reference to regulatory pressure or constraint.
  10. Any assessment of transplant center performance should be cognizant of the complexity of the transplant ecosystem and should hold transplant centers responsible only for those metrics within their control.
  11. ASTS supports the modification and enhancement of OPO performance metrics and believes that all key methodologies used in OPO performance evaluation should be based on verifiable and objective data.

 

ASTS Recommendations for Optimization of Transplant Center Assessment

Approved by ASTS Council January 12, 2021.

Executive Summary

Over the past several years, it has become clear that current patient and graft survival metrics disincentivize Transplant Center (TC) acceptance of organs at risk of discard and the transplantation of older and less healthy recipients. By discouraging aggressive organ acceptance practices, the current TC metrics create irreconcilable incentives for OPOs and TCs, and limit the number of transplants performed.

While the Centers for Medicare and Medicaid Services (CMS) has discontinued the use of patient and graft survival metrics as a condition of TC recertification, graft and patient survival-related metrics continue to be used by the Organ Procurement and Transplantation Network’s (OPTN) Membership and Professional Standards Committee (MPSC) to trigger TC performance evaluation that may result in the imposition of public sanctions and by the Scientific Registry of Transplant Recipients (SRTR) for the purposes of TC public star ratings. A growing consensus supports the necessity of modifying TC outcomes metrics

It is critical that any new metrics be developed with the input of the entire transplant community and include input from associations representing transplant surgeons, transplant physicians, OPOs, patient organizations and other affected stakeholders. While metrics used to trigger TC review by the MPSC will be implemented by the OPTN, and while public metrics will be calculated by the SRTR, organizations participating in the development of these metrics should not be limited to the OPTN and SRTR. It is critical that other stakeholders participate in the development of new metric regimes, rather than being relegated to token involvement during the public comment process. All the organizations whose members ultimately will be affected by new metrics should be allowed to participate meaningfully in their development. Without full participation of organizations representing the transplant community, new metrics are unlikely to be fully accepted. Token involvement of the stakeholders central to the initiatives and operations needed to increase the numbers of transplants performed will likely produce suboptimal results. Meaningful involvement in new metrics and flagging parameters by all stakeholders, including the ASTS, is likely to decrease the unanticipated consequences of these inevitably complex policy decisions and maximize the likelihood of successful implementation.

This White Paper outlines ASTS’ position on the development of new TC metrics and includes the following recommendations:

  • TC star ratings based on patient and graft survival should be eliminated. The objective of any new comparative ratings or other public metrics should be designed to meet the informational needs of potential transplant recipients.
  • SRTR Provider Specific Reports (PSRs) should contain data comparing TC outcomes with the outcomes of the primary treatment alternative for end stage organ failure (such as dialysis, in the case of renal transplantation).
  • Eliminate the current outcomes triggers for MPSC performance review of TCs and substitute a confidential peer review process designed to encourage TCs to increase the number of transplants performed without falling below established professionally acceptable outcomes parameters.
    • The current patient and graft survival metrics used to flag TCs for MPSC performance review should be replaced by a metric specifying a minimal fixed survival floor, similar to a pass/fail system, with the standard established at a level that encourages more aggressive utilization of organs at risk of discard.
    • We note that the MPSC has made an overt and laudable effort to make the focus of member engagement quality improvement rather than viewing its primary role as meting out punishment to members. This change has been salutary for members, the patients they serve and for the MPSC. We advocate that the MPSC continue this cultural change focusing on promoting quality improvement.
  • The development of metrics focused on the long-term effects of transplantation should be developed to facilitate research in the field but should not be used as TC performance outcome flagging.

ASTS looks forward to participating with other organizations representing the transplant community in establishing new measures of TC performance designed to meet the needs of transplant recipients and donors.

ASTS White Paper on Optimization of Transplant Center Assessment, January 12, 2021

 

ASTS Statement Concerning Eligibility for Solid Organ Transplant Candidacy

Drafted by the ASTS Ethics Committee and approved by the ASTS Council February 12, 2021

End stage organ disease results in extensive suffering, death, and cost in the United States and the world.

Presently, sufferers of many types of organ disease may be helped or saved by transplantation:

  • kidney
  • pancreas
  • liver
  • small intestine
  • heart
  • lung
  • uterus
  • face, limb, other portions of body lost to injury or disease

There is a longstanding discrepancy between the supply of transplantable organs and the numbers of people who need them.

  • There are presently over 108,000 patients wait listed for a solid organ transplant in the United States.
  • Over recent years, approximately 55,000 – 60,000 new patients have been added to the nation’s waitlist, annually.
  • In 2019 and 2020, approximately 39,000 solid organ transplants were performed per year, with lesser numbers in years prior.
  • Annually, between 5000 and 6000 patients die waiting for a solid organ transplant.[i]

These figures show that transplantable organs are a precious resource, in short supply, and that many people die before having an opportunity to receive this gift.

The American Society of Transplant Surgeons advocates transplanting as many of these patients, as quickly as possible, while also making the most responsible use of our nation’s organ supply. Limiting a transplanted organ’s life expectancy due to placing it with a patient, or in a situation, in which it cannot be adequately supported can deprive another waitlisted patient of a better outcome with the same organ.

To this end, we feel that any medically eligible patient, with sufficient support in place to allow for their adequate care following surgery, should be supported in their pursuit of transplantation.

When a patient presents to a transplant center for evaluation, the center makes a judgement concerning the patient’s medical fitness to undergo the procedure, and also the patient’s expected ability to capably care for themselves and a new organ.

If the patient has cognitive, physical, or financial limitations that would preclude them from being able to adequately care for themselves, then appropriate social supports or other compensatory mechanisms which would remediate the situation should be identified. If these can be found, then the patient’s candidacy for transplantation should be supported. If, however, they cannot be identified, proceeding with transplantation could threaten both the patient’s health and safety, and the longevity of a donated organ. In such a case, further evaluation should be deferred until the limiting issue can be corrected.

As such it is the recommendation of the ASTS that no patient will be discriminated against or precluded from transplant listing solely due to the presence of a disability or handicap, whether physical or psychological. However, if these disabilities lead to a clinical reality where the patient will suffer a great risk of morbidity or mortality from the transplant surgery itself, or the subsequent placement on lifelong immunosuppression, then transplantation would not be recommended. This decision would be made due to the clinical risk benefit analysis for the specific patient, and not on any external factors.

[i] OPTN National Data: https://optn.transplant.hrsa.gov/data/view-data-reports/national-data/. Accessed February 2021.

 

ASTS Statement on Islet Cell Transplantation Regulations

Drafted by Piotr Witkowski, MD, PhD and approved by the ASTS Executive Committee, December 23, 2020

The issue of declining islet cell transplantation and over regulation emerged from ASTS member Dr. Witkowski.

Definition of the Problem:

Islet allotransplantation in the United States (US) is facing an imminent demise, leaving patients with type 1 diabetes mellitus (T1DM) and severe hypoglycemia without access to a lifesaving therapeutic procedure.

The safety and effectiveness of allo-islet transplantation has been established in NIH-sponsored U.S. clinical trials as well as through the Collaborative Islet Transplantation Registry, U.S. taxpayer-funded research projects, which collectively have analyzed data from more than 2,000 allo-ITx procedures over the past 20 years. 

However, despite decades of progress in the field driven by U.S. academic centers, an archaic regulatory framework has stymied U.S. clinical practice. Current Food and Drug Administration (FDA) requirements for allogeneic islets for transplantation do not reflect the clinical or technical state-of-the-art.

  • Autologous islets (auto-islets) and allogenic islets (allo-islets) are sourced and processed identically, but are subject to vastly different FDA regulatory requirements:
    • Auto-islets, like many tissue- and cellular-based products, are subject to limited requirements aimed at ensuring appropriate collection, storage, processing, and distribution (Section 361 Public Health Service (PHS) Act).
  • Allo-islets, in contrast, are subject to much more extensive requirements because they are categorized as biological products (section 351 PHS Act and Federal Food, Drug and Cosmetics Act).
  • The distinction between auto- and allo-islets based on criteria established nearly 30 years ago (21 CFR Part 1271) do NOT reflect current standards and clinical practice. As a consequence, there has been significant impact on allo-islet transplantation effectively preventing its therapeutic use in the U.S.
    • In the past four years, only 11 patients have undergone allogenic islet transplantation (allo-ITx) in the U.S., all under an investigational protocol. In contrast, in Europe, Canada, Australia, and Japan, islets are NOT regulated as a drug and allo-ITx is a standard-of-care procedure annually benefiting hundreds of patients with type 1 diabetes.
  • Allo-islets in the U.S. require premarket approval of a biologics license application (BLA) and extensive post-market compliance obligations. The FDA’s requirements are geared to commercial manufacturers of drug products, and not to clinical transplant centers. Only a commercial (pharma/biotech) company realistically could comply with these requirements.Regulating transplant centers as drug manufacturers and requiring premarket approval for allo-islets effectively precludes clinical transplant centers from offering allo-ITx to patients, and preventing optimal patient care.
  • The first commercial entity to obtain FDA approval of a BLA for allo-islets will be eligible for seven years of market exclusivity, further limiting patient access to the therapy. The price for FDA-approved allo-islets produced by a commercial manufacturer foreseeably will be significantly inflated to recover enormous costs associated with preparing a BLA and complying with the manufacturing regulations for commercial drugs. The absence of competition, at least initially, will also escalate the price and discourage innovations in islet processing, to the detriment of patients who could benefit from this life-saving therapy.
  • Allowing the commodification of islets runs counter to the ethical norms underlying the organ and tissue transplantation framework, under which the sale of organs and tissues is prohibited and organ donation is viewed as an altruistic act.

The Solution:

We propose to harmonize the U.S. approach to allo-ITx with that of many other countries, which would allow for implementation of safe, effective, affordable, and widely accessible islets for transplantation as a standard of care procedure.

  • Specifically, we seek urgent modification of the FDA regulatory status of allo-islets, before a BLA is issued and orphan designation is awarded to a single commercial sponsor (which could happen as soon as March 2021).
  • Allo-islet regulation should be consistent with the regulation of auto-islets and other minimally-manipulated human tissue for transplantation.

We recommend that the FDA:

  1. Confirm islet allografts are “minimally manipulated” HCT/Ps as that term is defined in FDA regulations, because they are subject to only short-term incubation prior to allograft infusion that does not alter their relevant biological characteristics.
  2. Allow allogeneic islets from unrelated donors to be eligible for regulation as HCT/Ps exclusively under Section 361/Part 1271, provided that donors and recipients are immunologically compatible as determined by current clinical standards for immunological matching in organ and tissue transplantation.

We recommend that HRSA, through the United Network for Organ Sharing (UNOS)/Organ Procurement and Transplantation Network (OPTN), continue to oversee pancreas allocation and procurement and extend its oversight of transplant programs to include those that perform islet transplantation, which would allow HRSA to monitor the outcomes of patients receiving allo-ITx.  

The Conclusion:

Allo-islets is a “poster child” for archaic over-regulation. Adjusting the regulation would remove regulatory barriers, reflect our current clinical practice, and deal with our upcoming challenge. ASTS proposes the forementioned updates to current regulations as critical for the renaissance of ethical, safe, effective, and affordable allo-ITx in the United States.

 

ASTS Statement on Procurement of HIV+ Organs

Drafted by the ASTS Ethics Committee and approved by the Executive Committee, September 2020

The issue of surgeons declining to procure organs from HIV+ donors came forth to the leadership of the ASTS who asked the Ethics Committee to address this situation.

Definition of the problem:

HIV was once considered an absolute contraindication to organ donation. As the fields of transplantation and infectious diseases have advanced, protocols have been developed to consider utilization of organs from HIV+ donors, as organs continue to be a scarce resource. It came to the attention of the leadership committee that some surgeons have refused to procure organs from these donors. The leadership asked the Ethics Committee to address this concern.

ASTS Principles regarding procurement of organs from HIV+ donors

    1. HIV was once considered an absolute contraindication to organ donation. More recent data and protocols support the utilization of these organs for appropriate recipients to optimize beneficence.
    2. The United States government expressly endorses transplantation of HIV+ donor organs with the HIV Organ Policy Equity (HOPE) Act. Given the shortage of organs for transplantation, using HIV+ donor organs increases the availability of organs for transplantation for appropriate recipients (utility).
    3. The wishes of individuals with HIV who elect to donate their organs, either through living or deceased donation pathways, and are deemed appropriate donor candidates, should be respected based on the ethical principle of autonomy.
    4. There is excellent data that demonstrates the low risk of transmissibility of HBV, HCV, and HIV to health care workers. HIV is well-documented to be the least transmissible of the three. HCV is a common indication for liver transplantation and is an acceptable donor-derived infectious disease for deceased donor heart, lung, liver and kidney transplantation. Transplant surgeons are frequently exposed to HCV and do not cite this infection as a reason for refusal to perform donor or recipient operations, thereby suggesting that this reasoning is not valid for HIV+ donors.
    5. There is strong data to support the use of post-exposure prophylaxis in the setting of an actual or potential exposure. There has been no well-documented health-care worker seroconversion in surgery from direct patient contact since 1999.
    6. The ethical principle of beneficence is generally cited to support operating on patients with HIV who stand to benefit from the operation. While organ donors do not directly benefit from the procurement operation, organ transplant recipients do, so the principle of beneficence (e.g., maximizing benefits and minimizing harms) supports organ procurement from HIV+ donors.
    7. It is the position of the ASTS that refusing to procure organs from an HIV+ donor or refusing to operate on an HIV+ recipient is neither ethical nor scientifically sound. Utilization of organs from HIV+ donors should be encouraged and facilitated within the confines of well-designed protocols. Moreover, surgeons should utilize universal precautions when operating on all donors and recipients, not just those with known HCV, HBV or HIV, to reduce the risk of infectious disease transmission as recommended by the CDC since 1987, and part of standard precautions since 1995.

 

ASTS Statement on OPO Metrics

Drafted by the ASTS Executive Committee, September 2020

The American Society of Transplant Surgeons strongly supports efforts to increase the availability of life-saving organ transplants, which requires increasing the number of organs available for transplantation retrieved by Organ Procurement Organizations (OPOs). ASTS believes it is important not to significantly delay long-overdue modification of OPO metrics, which are currently subjective and self-reported. At the same time ASTS cautions that development of updated metrics must occur with appropriate involvement of the transplant and OPO community, with a thoughtful transition to new metrics that avoids unintended consequences that would adversely affect patients, such as simultaneous decertification of multiple OPOs.

OPO metrics must be put in place based on a potential donor “denominator” that is calculated based on a verifiable, objective methodology.[1] Assuming that no existing accurate alternative source of data reflecting hospital inpatient deaths can be identified,  ASTS believes that that the CDC’s National Center for Health Statistics’ Detailed Multiple Cause of Death (MCOD) data (with appropriate exclusions) should be utilized to identify potential donors, and that the transplant community should work with appropriate governmental organizations to address the shortcomings of this database.  

When significantly altering a complex system, both short- and long-term impacts must be considered.  At least during the transition to the new metrics, care should be taken to ensure that any new regulatory requirements encourage improved OPO performance without resulting in widespread and simultaneous decertification of a significant number of OPOs, which would be inconsistent with the needs of our patients. For this reason, any new system that is put in place should establish realistic standards and should retain sufficient flexibility to enable an OPO that is continuing to make  substantial improvement in meeting applicable outcomes requirements to retain certification, so long as it meets threshold and other improvement benchmark required by CMS that are tailored to take into account the circumstances of the particular OPO involved.  This will hopefully mitigate the potential disruption and adverse impacts to patients resulting from the decertification of an OPO, while improving OPO performance.

ASTS looks forward to working collaboratively with the OPO community, HRSA, and CMS in future discussions for development and updates on such metrics to ensure continued focus on the goal of maximizing the number of patient lives saved.

 

[1]public comments on the CMS OPO Conditions for Coverage Proposed Rule

 

ASTS Statement on Conscious DCD

Drafted by the ASTS Ethics Committee and finalized by the ASTS Executive Committee, June 2020

The issue of conscious DCD came forth to the leadership of the ASTS from a member who inquired whether the ASTS had a policy that would help guide members through these potentially emotionally charged situations. The leadership asked the Ethics Committee to address the member’s concern.

Definition of the problem:

There may be clinical situations in which the patient is able to communicate his/her wishes to be an organ donor upon actions that the patient desires the medical team to make that would facilitate death. Such conditions would include high c-spine fracture and cord injury, amyotrophic lateral sclerosis.

ASTS Principles Regarding Conscious DCD

  1. Donation from the conscious donor who dies after withdrawal of ventilator support with either a high c-spine fracture or with an illness such as amyotrophic lateral sclerosis is ethically appropriate based on the ethical principle of Autonomy
  2. If members or programs feel an ethical or moral obligation to not participate in this donation process, they should be able to decline to participate in the process of donation or the utilization of organs from such donations without penalty.
  3. Programs or members who decline to participate in the process of donation and utilization of organs from the “conscious donor” should prospectively notify the Organ Procurement Organization, which is responsible for identifying a willing surgeon or program. 
  4. In the acutely injured patient, it is likely that deferment of authorization of donation should take into account the emotional vulnerability of the injured patient and how it may impact decision-making. There should be a “cooling off” period between injury/diagnosis and the decision to initiate action that would lead to death and donation.
  5. There is a need for assurance that processes are in place to proceed with DCD donation in an ethically and clinically appropriate circumstance through the OPO.
  6. ASTS members should adhere to the dead donor rule.
  7. ASTS members do not condone euthanasia or assisted suicide.
  8. ASTS members are compelled to maintain the public trust.

Archived Statements

Volunteer Non Directed Live Donations June 1, 2008

Published on Mar 22, 2013, 17:04 PM by User Not Found