Author + information
- Published online April 16, 2018.
- Larry A. Allen, MD, MHS∗ ( and )
- Prateeti Khazanie, MD, MPH
- Division of Cardiology and the Colorado Cardiovascular Outcomes Research Consortium, University of Colorado School of Medicine, Aurora, Colorado
- ↵∗Address for correspondence:
Dr. Larry A. Allen, Division of Cardiology, University of Colorado School of Medicine, Academic Office 1, Room 7019, 12631 East 17th Avenue, Mail Stop B130, Aurora, Colorado 80045.
“Physicians’ primary ethical obligation is to promote the well-being of their patients.”
—American Medical Association Code of Medical Ethics (1)
“Organs should be distributed over as broad a geographic area as feasible.”
—The Final Rule (2)
“We have a match!” This is not the latest season of The Bachelor. It is heart transplantation. Our patients wait for weeks, months, perhaps years, often on the brink of death, for the perfect match that may or may not come. But is heart transplantation becoming like a behind-the-scenes reality show—competitive and cutthroat—with centers gaming patient management to win the proverbial red rose?
The first adult heart transplant in the United States was performed 50 years ago and remains the best therapy available for patients dying of advanced heart failure. Yet, in the last 2 decades we have been unable to significantly change organ availability. With approximately 60,000 advanced heart failure patients who are likely to benefit from transplant and yet <3,000 heart transplantations performed annually in the United States, transplantation centers compete within rules and regulations to secure suitable organs for their patients (3,4).
Recently, the heart allocation system has been called into question for multiple reasons, including the following: 1) the number of Status 1A (highest priority) candidates has doubled to >44% of all patients on the waiting list; 2) many exemption requests for higher priority status are being submitted, with >90% approved regionally; 3) the majority of transplantations are now done in patients supported with mechanical circulatory support (MCS), many are stable on left ventricular assist devices (VAD) with relatively low mortality; and 4) geographical disparities with regional differences in wait times and status at time of transplantation have grown (5–10).
Although many of these issues reflect demographic heterogeneity and the evolving use of MCS, there has been growing concern about gaming the waiting list. Advanced heart failure cardiologists live with an ongoing tension between advocating for their own patients in their program and upholding a fair process nationally (1,2). In its current form, the heart allocation system gives Status 1A to patients supported by 2 inotropes and a Swan-Ganz catheter, intra-aortic balloon pump (IABP), extracorporeal membrane oxygenation, or total artificial assist device. Additionally, patients with VAD receive 30 days of 1A time to be used at the center’s discretion. Those with specific VAD or medical complications can also obtain an exemption and jump to the front of the line. But these decisions are fraught with subjectivity. For example, if a patient has a cardiac index of 1.9 l/min/m2 but has tolerable symptoms, some cardiologists will choose to manage the patient medically whereas others will initiate inotropes; yet, only the latter increases priority on the transplant list. Has the current heart allocation system created a slippery slope toward more aggressive care when those decisions also lead to higher waiting list priority?
The study by Parker et al. (11) in this issue of the Journal is a timely contribution in an era as policies around heart transplant allocation are changing. These investigators used a clever approach to estimate to what extent differences in treatment choices may be influencing listing status. Leveraging the SRTR (Scientific Registry of Transplant Recipients), they matched hemodynamic data at the time of heart transplant listing with use of high-dose inotropes or IABP. They found marked differences by center in “potential overtreatment” of patients who were listed as Status 1A, as evidenced by use of high-dose inotropes with invasive hemodynamic monitoring or IABP despite an absence of American Heart Association hemodynamic criteria for cardiogenic shock: systolic blood pressure of ≤90 mm Hg, cardiac index of 1.8 l/min/m2 or less without inotropic or mechanical support or 2.2 l/min/m2 or less with support, and pulmonary capillary wedge pressure of >15 mm Hg (12). The odds of potential overtreatment were 17.5× higher in the top quartile of centers than in the bottom quartile and did not diminish with adjustment for other patient factors. Furthermore, these issues appeared to be exacerbated in “competitive markets” such as New York, Chicago, and Los Angeles, where there are multiple programs competing for transplant business. There was a trend toward better post-transplantation survival at top quartile centers, but there was no statistically significant difference in the hazard ratio (p = 0.08). At first glance, better survival may suggest that these top quartile centers are doing things the right way, but these patients may have had better survival because they were relatively early for transplant.
The premise highlighted by the study by Parker et al. (11)—that priority for heart transplant listing in the United States has relied primarily on treatment rather than intrinsic measures of disease severity—is particularly relevant as we move to a new heart transplant allocation system in 2018. The United Network for Organ Sharing, the nonprofit organization that operates the government contract for the Organ Procurement and Transplant Network, with the Health Resources and Services Administration, has proposed changes to the current allocation policy to address the changing landscape of advanced heart failure care (5,13). The new system includes 6 strata (1 to 6) versus the current 3 (1A, 1B, 2), broader geographic sharing of organs across the country for the highest-tier patients, more concrete definitions for MCS complications, and objective requirements that patients must meet the American Heart Association hemodynamic criteria for cardiogenic shock to warrant higher listing status (13). This study by Parker et al. (11) supports efforts to revise our current heart allocation system to limit potential overtreatment based on subjective decisions to use inotropes, invasive monitoring, and IABP support.
However, it should be noted that there are a number of limitations to the “objective” American Heart Association criteria for cardiogenic shock used in this study and in the new allocation system. Hemodynamic numbers are imprecise, clinicians have discretion in choosing whether to rely on Fick or thermodilution methods for cardiac output estimation, and measures of cardiac output do not correlate particularly well with patient outcome (14–16). Unfortunately, the SRTR dataset does not collect extensive data for more predictive markers of cardiogenic shock, such as liver function tests and lactate. Instead, the investigators were limited to variables recorded with high fidelity in the registry—objective data on renal function and subjective clinician-reported data on functional status—for the statistical adjustment (11). Finally, there was potential temporal uncoupling of hemodynamic data and medical decision making. Although efforts to link listing priority to objective data are noble, the devil is in the details.
Despite new rules being implemented, biased decision making remains a major concern. When the allocation system was last changed in 2006, there was a marked increase in use of inotropes and invasive monitoring (17,18). Similarly, the upcoming system could incentivize the use of resource-intensive and risky technologies that warrant listing priority: extracorporeal membrane oxygenation; nondischargeable biventricular or right VAD; and other temporary MCS. Meanwhile, patients with disease processes such as hypertrophic cardiomyopathy, restrictive cardiomyopathy, amyloidosis, prior transplants, and congenital heart disease fall to the lowest priorities, in a system that is likely to be more discouraging of exemptions.
Some heart transplantation specialists fear the new allocation system, envisioning the reality show The Bachelor where contestants scheme to win someone’s heart. The new system could possibly catalyze more—not less—gaming in heart transplantation. Despite the new system being more objective, we are still fundamentally determining organ priority primarily based on treatment decisions. With greater geographic sharing and new medical devices such as the Organ Care System (the “heart in a box”), some centers may fly long distances to snatch the rose (19). With a move toward more aggressive use of MCS, longer travel ischemic times, and lower priority for patients with certain heart conditions, we could further exacerbate disparities in care.
The architects of the new allocation plan have the best intentions of solving the disparities created by our current system. They better account for candidate outcomes, provide a more nuanced classification system, and incorporate extensive public and professional input (5,13). However, as history and reality shows demonstrate, fair play is not always natural. Clinicians making heart transplant allocation decisions are rarely consciously and flagrantly overtreating patients to outwit, outplay, and outlast one another, but, in the words of cognitive psychologist Dan Ariely, we all have a “personal fudge factor” (20). Therefore, we must continue to strive for an explicit and transparent system that ensures optimal fairness, within which clinicians can advocate for individual patients. Tune in for the next season as we move forward with the new allocation system.
↵∗ Editorials published in the Journal of the American College of Cardiology reflect the views of the authors and do not necessarily represent the views of JACC or the American College of Cardiology.
Dr. Allen has provided consulting services to Boston Scientific, Janssen, Amgen, and Novartis. Dr. Khazanie has reported that she has no relationships relevant to the contents of this paper to disclose.
- 2018 American College of Cardiology Foundation
- ↵American Medical Association. Allocating limited health care resources. Available at: https://www.ama-assn.org/delivering-care/allocating-limited-health-care-resources. Accessed February 8, 2018.
- ↵Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS). Organ procurement and transplantation network. Final rule. Fed Regist 2013;78:40033-42.
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