American Journal of Transplantation 2015; 15: 55–63 Wiley Periodicals Inc.

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Copyright 2014 The American Society of Transplantation and the American Society of Transplant Surgeons doi: 10.1111/ajt.13033

Meeting Report

Report From a Forum on US Heart Allocation Policy J. A. Kobashigawa1,*, M. Johnson2, J. Rogers3, J. D. Vega4, M. Colvin-Adams5, L. Edwards6, D. Meyer7, M. Luu1, N. Reinsmoen1, A. I. Dipchand8, D. Feldman9, R. Kormos10, D. Mancini11 and S. Webber12 on behalf of the forum participants 1

Advanced Heart Disease Section, Cedars-Sinai Heart Institute, Los Angeles, CA 2 Division of Cardiovascular Medicine, University of Wisconsin, Madison, WI 3 Division of Cardiology, Duke University, Durham, NC 4 Division of Cardiothoracic Surgery, Emory University, Atlanta, GA 5 Cardiovascular Division, University of Minnesota, Minneapolis, MN 6 United Network for Organ Sharing, Richmond, VA 7 Department of Cardiovascular and Thoracic Surgery, University of Texas Southwestern, Dallas, TX 8 Division of Cardiology, Department of Paediatrics, University of Toronto, Toronto, Ontario, Canada 9 Cardiovascular Services Division, Minneapolis Heart Institute, Minneapolis, MN 10 Division of Cardiology, University of Pittsburgh, Pittsburgh, PA 11 Division of Cardiology, Columbia University Medical Center, New York, NY 12 Department of Pediatrics, Vanderbilt University, Nashville, TN  Corresponding author: Jon A. Kobashigawa, [email protected]

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 everdeveloping 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. Abbreviations: AL, amyloid light-chain; DHHS, Department of Health and Human Services; IV, intravenous; LVAD, left ventricular assist device; MCS, mechanical circulatory support; OPO, organ procurement organization; OPTN, Organ Procurement and Transplantation Network; SRTR, Scientific Registry of Transplant Recipients; TAH, total artificial heart; TTR, transthyretin; UNOS, United Network for Organ Sharing; VAD, ventricular assist device Received 05 May 2014, revised 23 July 2014 and accepted for publication 03 August 2014

Introduction On November 15, 2013 in Dallas, Texas, a forum on US adult heart allocation policy took place. This forum aimed to ascertain the current understanding of US heart allocation policy in the heart transplant community, discuss current issues related to US heart allocation policy and identify the spectrum of concepts that the community recommends for consideration during the policy development process. The forum was financially underwritten by Cedars-Sinai Heart Institute and developed in collaboration with the American Society of Transplantation, American Society of Transplant Surgeons, and the United Network for Organ Sharing (UNOS). The Scientific Registry of Transplant Recipients (SRTR) lists 141 active transplant centers (defined as centers that performed one or more heart transplants in the last year) as of June 30, 2013. Centers with a track record of multiple transplants for multiple years were preferentially invited, with the aim of achieving a balance of small, medium and large centers. Of 130 potential participants from 84 select transplant centers that were originally invited, the conference had 84 participants who had both clinical and published experience in heart transplantation (including transplant cardiologists, cardiac surgeons, immunologists 55

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and members from the Organ Procurement and Transplantation Network (OPTN)/UNOS Thoracic Organ Transplantation Committee and SRTR (see Appendix A) who represented 51 heart transplant centers across the contiguous US.

Background The National Organ Transplant Act (1984) was responsible for the formation of OPTN, the unified transplant network that governs organ transplantation in the United States. UNOS, based in Richmond, Virginia, serves as the OPTN under contract with the Health Resources and Services Administration of the US Department of Health and Human Services and is charged with developing allocation policy. Since the inception of the OPTN, allocation policy has undergone several iterations. In 1988, an urgency-based system was adopted. Further major revisions occurred in 1999, with the introduction of a higher priority for sicker Status 1 patients (and thus the creation of Status 1A and 1B), and in 2006, which allowed broader regional organ sharing. As governed by the Final Rule, issued by the Department of Health and Human Services in 2000, each change in policy attempts to meet the difficult combination of equitable organ allocation (including across regions) while prioritizing according to severity of illness. The current OPTN heart allocation policy was the result of a 2006 revision, which involved broader regional sharing of donor hearts to Status 1A and 1B candidates before allocating to Status 2 candidates (before, an organ was only offered to Status 1A/1B candidates within its particular region). This revised policy demonstrated efficacy in decreasing waitlist mortality for Status 1A/1B candidates while maintaining their posttransplant survival rate (1). However, while Status 2 candidates now display 1-year survival comparable to heart transplant recipients (2), Status 1A waitlist mortality is still high compared to Status 1B patients (3). In the years since the 2006 revision, the landscape of the heart transplant waitlist has changed considerably. There have been recent significant advances in the management of heart failure patients, notably in the field of mechanical circulatory support (MCS) as a bridge to transplantation. The advent of the continuous flow nonpulsatile ventricular assist device (VAD) has resulted in vastly improved survival rates in MCS patients, and has contributed to reduced waitlist mortality (4,5). This raises the question as to how these increased numbers of waitlist patients should be prioritized. In addition, several disadvantaged subgroups awaiting transplant must be considered. These subgroups involve those with restrictive cardiac physiology and preserved systolic function such as hypertrophic cardiomyopathy and amyloid patients (1,6). These patients generally do not benefit from left VAD (LVAD) therapy, and generally do not meet Status 1A criteria despite sometimes having 56

significant diastolic dysfunction. Highly sensitized patients may also be at a disadvantage (7), as a result of a smaller compatible donor pool, resulting in increased waitlist time. Patients with a life threatening arrhythmia (8) and congenital heart disease (9) have also been demonstrated to be disadvantaged, due to difficulties qualifying for Status 1A. Based on the experience of many of the participants, unstable angina patients are also at a disadvantage. As patients within a status are prioritized based on time spent at that status or in a more urgent status, there is not a differentiation between levels of disease severity within a specific status. Studies have also demonstrated a disparity between various regions in waitlist time (3). This can potentially impact both waitlist and posttransplant morbidity and mortality between regions, especially if hearts are only allocated to gravely ill patients as a result. Currently, organs are allocated by organ procurement organization (OPO) donation service area, then concentric geographic zones at intervals of 500 miles centered at the donor hospital. Furthermore, given that demand continues to exceed supply, multiple ethical concerns regarding heart allocation cannot be ignored. For example, the fairness of the practice of multiple listing, and the consideration of who to list for re-do heart transplants, are fiercely debated issues. Given these areas of contention, this national forum was proposed in order to fulfill an unmet need for broader discussion of these important issues in US heart allocation policy, with the aim of highlighting key policy areas that are of greatest concern to the heart transplant community. This report provides a summary of the results of group discussions on the topic and survey data collected after the conference when participants had time to carefully respond to the survey questions. The data from this paper should provide a useful conceptual aid for further development of US heart allocation policy.

Breakout Sessions Regarding US Heart Allocation Policy While there were specific background presentations that took place in the morning of the forum, the afternoon was devoted to breakout discussion sessions. After the presentations, the participants were divided into four breakout groups to allow for further discussion and interaction. Each group included a mix of cardiologists, cardiac surgeons, immunologists and members of the OPTN/UNOS Thoracic Organ Transplantation Committee.

Results From Forum Survey on US Heart Allocation Policy After the breakout sessions, the reconvened participants engaged in discussions focused on salient topics pertaining American Journal of Transplantation 2015; 15: 55–63

US Heart Allocation Forum

to heart allocation. In addition, a postmeeting survey regarding thoughts on heart allocation policy issues was completed by participants from the transplant centers represented at the conference. Characteristics of Participating Transplant Centers From the 84 participants, 51 respondents from 44 centers completed the survey. Seven centers were represented twice (designated as ‘‘double respondents’’). Respondents were either director of the transplant program or highly experienced faculty within the program. In this survey, there was balanced representation of the US heart transplant community, which included varying heart transplant program volumes, diverse geographical/OPO regions and centers implanting LVADs and total artificial hearts (TAH). Transplant volume was defined by the mean number of transplants per year conducted in 2011 and 2012. Small centers were defined as those conducting 1– 20 transplants/year, medium centers were defined as 21– 40 transplants/year and large centers were defined as >40 transplants/year. Of the 44 centers, 39% were small, 43% were medium and 18% were large centers. Concerning MCS, all of the participating centers performed LVAD implantations, while 50% of participating centers at the time of this meeting were certified to perform TAH (CardioWest, SynCardia Systems, Tucson, AZ) implantation. The proportion of double respondents was not significantly different between transplant volume sizes and TAH/non-TAH centers, reducing the chances of skewing the data. Survey Methodology and Interpretation The survey came in the form of 25 questions (e.g. ‘‘Should the establishment of a national review board be considered?’’) followed by four response options: ‘‘Strongly Agree,’’ ‘‘Agree,’’ ‘‘Disagree’’ and ‘‘Strongly Disagree.’’ The responses from the group were interpreted along set percentage boundaries to characterize the prevailing view on the topic, from ‘‘Very strong interest’’ to ‘‘Very strong disinterest’’ (see Table 1). In order to standardize interpretation of the responses, the highest combined percentage of two responses are interpreted as follows: If 90% of responses agree/strongly agree then this is regarded as ‘‘Very strong interest’’; if 70–89% of responses agree/ strongly agree then this is regarded as ‘‘Strong interest’’; if 60–69% of responses agree/strongly agree then this is regarded as ‘‘Interest’’; if

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 i...
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