Research opportunities and ethical considerations for heart and lung xenotransplantation research: A report from the National Heart, Lung, and Blood Institute workshop.

Xenotransplantation offers the potential to meet the critical need for heart and lung transplantation presently constrained by the current human donor organ supply. Much was learned over the past decades regarding gene editing to prevent the immune activation and inflammation that cause early organ injury, and strategies for maintenance of immunosuppression to promote longer-term xenograft survival. However, many scientific questions remain regarding further requirements for genetic modification of donor organs, appropriate contexts for xenotransplantation research (including nonhuman primates, recently deceased humans, and living human recipients), and risk of xenozoonotic disease transmission. Related ethical questions include the appropriate selection of clinical trial participants, challenges with obtaining informed consent, animal rights and welfare considerations, and cost. Research involving recently deceased humans has also emerged as a potentially novel way to understand how xeno-organs will impact the human body. Clinical xenotransplantation and research involving decedents also raise ethical questions and will require consensus regarding regulatory oversight and protocol review. These considerations and the related opportunities for xenotransplantation research were discussed in a workshop sponsored by the National Heart, Lung, and Blood Institute, and are summarized in this meeting report.

The Changing Landscape of Catholic Hospitals and Health Systems, 2008-2017.

EXECUTIVE SUMMARY: More than 600 Catholic hospitals operating in the United States face pressures for efficiency and effectiveness as well as compliance with demands of the Roman Catholic Church. They have responded to the pressures in various ways that have led to mixed models of organizational ownership and management. The purpose of this study was to describe and analyze the status of Catholic hospital ownership and management, especially the strategic and structural features of the parent health systems. Longitudinal data (2008-2017) were acquired and analyzed using repeated-measures analysis. Descriptive statistics were prepared using cross-sectional matched pairing for 2008 and 2017 data. Of 4,253 hospitals studied, 534 changed ownership or management. More Catholic Church-operated hospitals, regardless of type of ownership (for-profit, not-for-profit, church), became decentralized to a greater degree over the 8-year period and took on more attributes of non-Catholic hospitals.The 21st century Catholic hospital is more likely to be partnered with a non-Catholic hospital or to be owned by a for-profit system than to be solely partnered with or operated by another Catholic system. Today's Catholic hospitals appear to be more similar to their non-Catholic counterparts. With the trend toward larger systems that comprise more diverse partners, an increase in lay oversight could lead to further movement away from Catholic identity and the original mission of a hospital. As systems grow in size but shrink in number, administrators must make difficult decisions about the type and scope of services offered as well as the partners they need to deliver their services.

Knowledge gaps in heart and lung donation after the circulatory determination of death: Report of a workshop of the National Heart, Lung, and Blood Institute.

In a workshop sponsored by the U.S. National Heart, Lung, and Blood Institute, experts identified current knowledge gaps and research opportunities in the scientific, conceptual, and ethical understanding of organ donation after the circulatory determination of death and its technologies. To minimize organ injury from warm ischemia and produce better recipient outcomes, innovative techniques to perfuse and oxygenate organs postmortem in situ, such as thoracoabdominal normothermic regional perfusion, are being implemented in several medical centers in the US and elsewhere. These technologies have improved organ outcomes but have raised ethical and legal questions. Re-establishing donor circulation postmortem can be viewed as invalidating the condition of permanent cessation of circulation on which the earlier death determination was made and clamping arch vessels to exclude brain circulation can be viewed as inducing brain death. Alternatively, TA-NRP can be viewed as localized in-situ organ perfusion, not whole-body resuscitation, that does not invalidate death determination. Further scientific, conceptual, and ethical studies, such as those identified in this workshop, can inform and help resolve controversies raised by this practice.