Heart transplant in Jehovah's Witness patients: A case-control study.

Heart transplantation (HTx) improves quality of life and survival in patients with advanced heart failure. Jehovah's Witnesses (JW) patients decline blood transfusion (including red cells, plasma and platelets) and are prohibited from heart transplantation at many centers. We report our experience with 20 consecutive JW patients with advanced heart failure who declined blood products referred to our center for HTx consideration. Of these, 7 were declined for transplant due to prior sternotomy, need for multi-organ transplant, or being too well. Of 13 JW patients accepted for heart transplant listing, 8 underwent HTx at our center. Compared to non-JW controls without prior cardiac surgery matched for age and listing status, JW HTx recipients had comparable incidence of primary graft dysfunction, rejection, allograft vasculopathy, and survival and hemoglobin up to 1 year. With appropriate selection, patients who are JW and decline blood products may successfully undergo heart transplantation.

Potential for donation after circulatory death heart transplantation in the United States: Retrospective analysis of a limited UNOS dataset.

Donation after Circulatory Death (DCD) is an alternative to Donation after Brain death (DBD), and is a growing strategy for organ procurement in the United States(US). The purpose of this analysis was to review the number and quality of hearts in one United Network for Organ Sharing (UNOS) Region that were not utilized as a potential consequence of nonheart DCD donation. We retrospectively identified all successful US DCD solid organ donors from 1/2011 to 3/1/2017, defined an ideal heart donor by age and left ventricular ejection fraction (LVEF), and then reviewed the donor charts of unused hearts in New York and Vermont (UNOS Region 9). Of 8302 successful DCD donors across the United States, 5033 (61%) were between 18 and 49 years of age, and 872 had a screening echocardiogram, with 573 (66%) measuring an EF >50%. Of these 573 potential donors, 44 (7.7%) were from Region 9. Detailed donor chart review identified 36 ideal heart donors, 24 (66.7%) with anoxic brain injury. Trends in Region 9 DCD donation increased from 4 unused hearts in 2011, to 13 in 2016. In the context of severe organ scarcity, these data indicate that implementation of DCD heart transplantation in the United States would improve overall donation rates and provide a pathway to utilize these ideal donor hearts.

Reuse of cardiac organs in transplantation: an ethical analysis.

BACKGROUND: This paper examines the ethical aspects of organ transplant surgery in which a donor heart is transplanted from a first recipient, following determination of death by neurologic criteria, to a second recipient. Retransplantation in this sense differs from that in which one recipient undergoes repeat heart transplantation of a newly donated organ, and is thus referred to here as "reuse cardiac organ transplantation." METHODS: Medical, legal, and ethical analysis, with a main focus on ethical analysis. RESULTS: From the medical perspective, it is critical to ensure the quality and safety of reused organs, but we lack sufficient empirical data pertaining to medical risk. From the legal perspective, a comparative examination of laws in the United States and Japan affirms no illegality, but legal scholars disagree on the appropriate analysis of the issues, including whether or not property rights apply to transplanted organs. Ethical arguments supporting the reuse of organs include the analogous nature of donation to gifts, the value of donations as inheritance property, and the public property theory as it pertains to organs. Meanwhile, ethical arguments such as those that address organ recycling and identity issues challenge organ reuse. CONCLUSION: We conclude that organ reuse is not only ethically permissible, but even ethically desirable. Furthermore, we suggest changes to be implemented in the informed consent process prior to organ transplantation. The organ transplant community worldwide should engage in wider and deeper discussions, in hopes that such efforts will lead to the timely preparation of guidelines to implement reuse cardiac organ transplantation as well as reuse transplantation of other organs such as kidney and liver.

Porcine to Human Heart Transplantation: Is Clinical Application Now Appropriate?

Cardiac xenotransplantation (CXTx) is a promising solution to the chronic shortage of donor hearts. Recent advancements in immune suppression have greatly improved the survival of heterotopic CXTx, now extended beyond 2 years, and life-supporting kidney XTx. Advances in donor genetic modification (B4GALNT2 and CMAH mutations) with proven Gal-deficient donors expressing human complement regulatory protein(s) have also accelerated, reducing donor pig organ antigenicity. These advances can now be combined and tested in life-supporting orthotopic preclinical studies in nonhuman primates and immunologically appropriate models confirming their efficacy and safety for a clinical CXTx program. Preclinical studies should also allow for organ rejection to develop xenospecific assays and therapies to reverse rejection. The complexity of future clinical CXTx presents a substantial and unique set of regulatory challenges which must be addressed to avoid delay; however, dependent on these prospective life-supporting preclinical studies in NHPs, it appears that the scientific path forward is well defined and the era of clinical CXTx is approaching.

Changing Role of Heart Transplantation.

Heart transplantation has become standard of care for end-stage heart failure. Challenges include the limited supply of donor organs and the increased complexity of heart transplant candidates who are at higher risk for poor outcomes. Recent advances may address these challenges, including proposed changes in heart transplant allocation policy, a better understanding of the definition and management of primary graft dysfunction, and advances in the management of sensitized heart transplant candidates. Developments in these areas may result in more equitable distribution and expansion of the donor pool and improved quality of life and survival for heart transplant recipients.

Is heart transplantation after circulatory death compatible with the dead donor rule?

Dalle Ave et al (2016) provide a valuable overview of several protocols for heart transplantation after circulatory death. However, their analysis of the compatibility of heart donation after circulatory death (DCD) with the dead donor rule (DDR) is flawed. Their permanence-based criteria for death, which depart substantially from established law and bioethics, are ad hoc and unfounded. Furthermore, their analysis is self-defeating, because it undercuts the central motivation for DDR as both a legal and a moral constraint, rendering the DDR vacuous and trivial. Rather than devise new and ad hoc criteria for death for the purpose of rendering DCD nominally consistent with DDR, we contend that the best approach is to explicitly abandon DDR.

[Current Status and Future Aspects of Heart Transplantation in Japan].

By renewal of Japanese Organ Transplantation Act on 17th July in 2010, organs can be donated after brain death with consent from their family, if he or she did not deny organ donation and brain dead organ donation increased from 10 to 50 cases in a year. Despite of an increase of heart transplantation (HTx), a waiting period for HTx has become longer because more candidates for HTx have been registered to Japan Organ Transplant Network. By renewal of the act, organ donation from brain dead children can be performed since then and pediatric left ventricular assist device, EXCOR was finally accepted to use in August 1st, 2015. However, only 3 children under 6 years of age have donated since then and oversea HTx increased again.

Transplantation of the heart after circulatory death of the donor: time for a change in law?

Australia has a shortfall in donated hearts for transplantation. Hearts are usually procured from brain dead donors, but procurement from circulatory dead donors is a potential additional source. However, heart transplantation after circulatory death of the donor may not conform to the dead donor rule. An amendment in law is required to permit heart procurement for transplantation after circulatory death.

Report from a forum on US heart allocation policy.

Since the latest revision in US heart allocation policy (2006), the landscape and volume of transplant waitlists have changed considerably. Advances in mechanical circulatory support (MCS) prolong survival, but Status 1A mortality remains high. Several patient subgroups may be disadvantaged by current listing criteria and geographical disparity remains in waitlist time. This forum on US heart allocation policy was organized to discuss these issues and highlight concepts for consideration in the policy development process. A 25-question survey on heart allocation policy was conducted. Among attendees/respondents were 84 participants with clinical/published experience in heart transplant representing 51 US transplant centers, and OPTN/UNOS and SRTR representatives. The survey results and forum discussions demonstrated very strong interest in change to a further-tiered system, accounting for disadvantaged subgroups and lowering use of exceptions. However, a heart allocation score is not yet viable due to the long-term viability of variables (used in the score) in an ever-developing field. There is strong interest in more refined prioritization of patients with MCS complications, highly sensitized patients and those with severe arrhythmias or restrictive physiology. There is also strong interest in distribution by geographic boundaries modified according to population. Differences of opinion exist between small and large centers.

[Cardiac graft allocation]. / La répartition des greffons cardiaques.

Until 2004, French rules for cardiac graft allocation were aimed at ensuring uniform organ distribution on the national scale, while logically giving priority to local teams. The allocation was center-based, with transplant MDs choosing the most suitable recipient from the local waiting list. In 2004, two national priority lists were added to the French cardiac graft allocation system. High Emergency 1 (HE1) is for patients with unstable hemodynamic status (on inotropes or ECMO), while High Emergency 2 (HE2) is for patients who develop complications during long-term circulatory support. Data from the French Biomedicines Agency show significantly poorer survival for HE1 patients than for HE2 patients. However, this should not lead to the conclusion that HE2 is a better strategy, as mortality during long-term circulatory support is not taken into account, and it is well known that the survival benefit of transplantation is significantly better in HE1 patients. Furthermore, the risk related to the quality of the cardiac graft must be taken into account. Indeed, the decision to transplant or not to transplant an HE1 patient with a given graft will impact not only the survival of the patient concerned, but also the waiting time of the other patients on the list, independently of allocation rules. This is also true for the criteria used to place a patient on the waiting list. Each cardiac transplantation team considers the level of risk before adding a patient to the waiting list, and this will impact not only the individual candidate but also the entire waiting list. Thus, even if allocation rules aim to provide all patients with the same chance of being transplanted across the entire country, the medical decision to accept a cardiac graft and to register a patient on the waiting list will make this process somewhat heterogeneous. This allows cardiac transplantation to be adapted to each individual case, independently of the rules. However, a multidisciplinary decision process is necessary to ensure fairness.

Ethics of the heart: ethical and policy challenges in the treatment of advanced heart failure.

Heart failure is a major cause of morbidity and mortality in the United States and worldwide, accounting for immense health-care costs. Advanced therapies such as transplantation, ventricular assist devices, and implantable cardioverter defibrillators have had great success in significantly improving life expectancy and morbidity, however these advances have contributed substantially to the economic burden associated with this epidemic. Concomitantly, the accessibility of these advanced therapies is limited, due to a finite number of available organs for heart transplantation and, in the future, the economic costs associated with both transplant and device therapy. This article discusses ethical and policy challenges in the treatment of advanced heart failure, including decisions regarding procurement of hearts for transplant and allocation to recipients; and the complex issues surrounding the use of implantable cardioverter defibrillators and ventricular assist devices, including quality of life, advanced directive planning in the context of these devices, and resource utilization. Based on these challenges, we recommend that a discussion of these complex matters be incorporated into cardiovascular training programs.

First pediatric heart transplantation from a pediatric donor heart in Japan.

BACKGROUND: Since the revision of the Japanese Organ Transplantation Act, children younger than 15 years old can donate their organs after brain death. METHODS AND RESULTS: A teenage boy with endstage restrictive cardiomyopathy underwent the first heart transplantation with a pediatric donor heart in Japan on April 12, 2011. He had a good postoperative clinical course and no histological rejection episodes. His waiting period was relatively short (237 days) compared with adult patients, because of the pediatric patient-first policy for a pediatric donor heart. CONCLUSIONS: To increase pediatric heart transplantation in Japan, further enlightenment of the general population about pediatric organ donation is desirable.