Status 1A
A patient listed as Status 1A is an admitted inpatient at the listing transplant center hospital or an affiliated VA hospital and has at least one of the following devices or therapies in place:
(a)
Mechanical circulatory support for acute hemodynamic decompensation that includes at least one of the following:
(i)
Left and/or right ventricular assist device implanted for 30 days or less (the 30 days do not have to be consecutive);
(ii)
Total artificial heart (TAH);
(iii)
Intra-aortic balloon pump (IABP); or
(iv)
Extra-corporeal membrane oxygenator (ECMO).
(b)
Mechanical circulatory support for more than 30 days with objective medical evidence of significant device related complications such as thromboembolism, device infection, mechanical failure, and/or life-threatening ventricular arrhythmias. Sensitization is not an acceptable device-related complication; any complications not listed here will be reviewed by the Regional Review Board.
(c)
Requiring continuous mechanical ventilation.
(d)
Continuous infusion of a single high-dose intravenous inotrope (e.g. dobutamine ≥ 7.5 μg/kg/min, or milrinone ≥ 0.50 μg/kg/min), or multiple intravenous inotropes, in addition to continuous hemodynamic monitoring of left ventricular filling pressures. OPTN-approved definitions for qualifying inotropes and doses are maintained by the OPTN Contractor.
Qualification for Status 1A under this criterion is valid for 7 days with a one-time 7-day renewal for each occurrence of a Status 1A listing for the same patient.
(Exception)
A patient who does not meet the criteria specified in (a), (b), (c) or (d) may be listed as Status 1A if the patient is admitted to the listing transplant center hospital and has documented need for urgent listing, for example a life expectancy without a heart transplant of less than 7 days.
A patient listed as Status 1A under this criterion shall be retrospectively reviewed by the applicable UNOS Regional Review Board and the UNOS Thoracic Organ Transplantation Committee.
Status 1B
A patient listed as Status 1B has at least one of the following devices or therapies in place:
(a)
Left and/or right ventricular assist device implanted for more than 30 days; or
(b)
Continuous infusion of intravenous inotropes.
(Exception)
A patient who does not meet the criteria specified in (a) or (b) may be listed as Status 1B if the patient has documented need for more urgent listing.
A patient listed as Status 1B under this criterion shall be retrospectively reviewed by the applicable UNOS Regional Review Board and the UNOS Thoracic Organ Transplantation Committee.
Status 2
A patient who does not meet the criteria for Status 1A or 1B is listed as Status 2.
Status 7
A patient listed as Status 7 is considered temporarily unsuitable to receive a thoracic organ transplant.
While the principles of a three-tiered status system have stayed constant since 1999, current policy is the result of a 2006 revision, which aimed to improve equitability by involving broader regional sharing of donor hearts to Status 1A and 1B candidates to a neighboring OPO (Zone A) before allocating to local Status 2 candidates; prior to 2006, an organ was offered to local Status 1A, 1B and 2 candidates before being offered to Status 1A/1B candidates in a neighboring region, or zone. This revised policy demonstrated efficacy in decreasing waitlist mortality for Status 1A/1B candidates while maintaining their post-transplant survival rate [4]. Generally, organ preservation considerations (see Chap. 7) limit the geographic distance that a donor organ may be transported to a recipient. The national allocation algorithm by geographic region is detailed in Table 4.2.
Table 4.2
Current (as of 2006) National Heart Allocation Algorithm by Geography: United States
Area | In order of priority |
|---|---|
Local | Status 1A candidates |
Status 1B candidates | |
Zone A | Status 1A candidates |
Status 1B candidates | |
Local | Status 2 candidates |
Zone B | Status 1A candidates |
Status 1B candidates | |
Zone A | Status 2 candidates |
Zone B | Status 2 candidates |
Zone C | Status 1A candidates |
Status 1B candidates | |
Status 2 candidates | |
Zone D | Status 1A candidates |
Status 1B candidates | |
Status 2 candidates | |
Zone E | Status 1A candidates |
Status 1B candidates | |
Status 2 candidates |
Current Controversies in Heart Allocation
As per the Final Rule, ensuring fair and equitable allocation of organs in the US is the charge of the OPTN/UNOS, in order to allow access to organs to the patients most in need and those that would benefit most from transplant. However, these principles can present a difficult conundrum. The concept of fairness is difficult to apply to the waitlist population. Ideally, it would mean that all patients with end-stage heart disease of equivalent severity would have an equal chance of obtaining a transplant, regardless of geographic location, although this is unrealistic to measure. While waiting time has also been proposed as a measure of fairness, the argument is clouded by the expectation by many that sicker patients should wait less time for a transplant (because they are more likely to die). Further complicating the issue is the fact that there is no uniform set of rules when it comes to initiating inotropic and other invasive therapy that might elevate a patient’s priority status. Furthermore, the currently proven regional variation in waitlist time [5] certainly undercuts the concept of fairness in heart allocation. The current disparity between various regions in waitlist time impacts both waitlist and post-transplant morbidity and mortality between regions, especially if hearts are only allocated to gravely ill patients as a result.
The concept of utility is also important in heart allocation. Given the donor heart shortage, and the known poor post-transplant outcomes in critically ill patients (e.g. those on extra-corporeal membrane oxygenation support), it could be considered ethically irresponsible to “waste” precious donor hearts by simply transplanting the sickest patients first. Thus, it is generally accepted that donor hearts should only be allocated to candidates in whom there is a reasonable expectation of post-transplant survival and in whom transplantation is the only reasonable option (compared to an LVAD, which might in certain circumstances provide a similar duration and quality of life to transplantation). Defining survival benefit can also be troublesome: is it better to transplant a heart that will produce a 30% to 70% improvement in life expectancy rather than a 70% to 90% improvement?
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