The proposed donor heart selection guidelines provide evidence-based and expert-consensus recommendations for the selection of donor hearts following brain death. These recommendations were compiled by an international panel of experts based on an extensive literature review.
Keywords
Abbreviations:
ACAOS (anomalous origination of a coronary artery from the opposite sinus), ACC (American College of Cardiologists), BMI (body mass index), BNP (B-type natriuretic peptide), CABG (coronary artery bypass graft), CAD (coronary artery disease), CAV (cardiac allograft vasculopathy), CNS (central nervous system), CO (carbon monoxide), COVID-19 (coronavirus disease 2019), CPR (cardiopulmonary resuscitation), CT (computed tomography), ECG (electrocardiogram), ECMO (extracorporeal membrane oxygenation), HIV (human immunodeficiency virus), HLA (human leukocyte antigens), INTERMACS (interagency registry for mechanically assisted circulatory support), ISHLT (International Society for Heart and Lung Transplantation), INH (isonicotinic acid hydrazide), LV (left ventricle), LVEF (left ventricular ejection fraction), LVH (left ventricular hypertrophy), MRI (magnetic resonance imaging), NT-proBNP (N-terminal prohormone of B-type natriuretic peptide), OPO (organ procurement organization), OPTN (organ procurement and transplantation network), PCI (percutaneous coronary intervention), PGD (primary graft dysfunction), pHM (predicted heart mass), PLSVC (persistent left superior vena cava), SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2), TTE (transthoracic echocardiography), UNOS (united network for organ sharing), VA (veno-arterial), VAD (ventricular assist device), VV (veno-venous), WHO (World Health Organization)In 1995, Dr J. Copeland noted that “only optimal donors should be accepted for heart transplantation,” implying that extended-criteria donor organs may not be viable.
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Despite this awareness raised from over 25 years ago, this topic has remained much debated. While older donors are more routinely used in Europe, younger donors with short ischemic times are more commonly used in the United States. Mortality rates differ worldwide, and some of these differences are due to donor selection and/or recipient urgency. Seeking a balance between maximizing the number of transplants (by taking greater risk) and minimizing the risk to meet societal needs, while controlling cost, is difficult and frequently related to a lack of reliable data regarding both donors and recipients. The issue is further complicated by the fact that the peri-operative surgical risk is a combination of risk factors that include donor, recipient, and ischemic time. Lastly, meaningful comparisons of transplant outcomes across countries require proper risk-adjustment.The proposed guidelines provide evidence-based as well as expert-consensus recommendations for the selection of donors following brain death. These recommendations were compiled by an international panel of experts based on an extensive literature review. Controversial subjects are dealt with one by one and current state-of-the-art information is provided to help define risk. The strength of each recommendation and the corresponding level of available evidence were classified following the International Society for Heart and Lung Transplantation protocol for developing guideline documents.
2
International Society for Heart Lung Transplantation. Protocol and policies for developing standards statements, guidelines, and consensus documents and for conducting consensus conferences. 2017; https://ishlt.org/ishlt/media/documents/STANDARDS_AND_GUIDELINES_DEVELOPMENT_PROTOCOL_FINAL.pdf
Task forces were established with an international panel of experts. The task forces reviewed donor characteristics (Task force 1), international donor practices (Task force 2), donor and recipient matched characteristics (Task force 3), extended donor characteristics (Task force 4), and donor risk scores (Task force 5).
Clinical stability of the donor
Factors considered in the clinical stability of the cardiac donor are hemodynamics, hormonal resuscitation,
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and the restoration of intravascular volume and electrolyte imbalance,12
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as well as donor metabolism.Recommendations for donor hemodynamics:21,23, 24, 25, 26, 27, 28, 29, 30, 31
Class I
- 1.Donors receiving low dose norepinephrine (e.g., ≤0.1 µg/kg/min) may be considered suitable for transplantation if (other) inotropes are not required. In general, the higher the dose of norepinephrine in the donor, the poorer the expected outcome after transplant. Level of Evidence: C.
Class IIa
- 1.If inotropes and/or vasopressors are required to maintain adequate circulatory function in the donor, placement of a Swan-Ganz catheter and goal-directed therapy should be considered to maximize the likelihood of donor heart utilization. Level of Evidence: C.
- 2.Suggested hemodynamic targets for donor hearts include the following:
- •Mean arterial pressure >60 mm Hg
- •Cardiac index >2.4 liter/min/m2
- •Central venous pressure <12 mm Hg
- •Pulmonary capillary wedge pressure <12 mm Hg
- •Left ventricular (LV) stroke work index >15 g·min/m2
- •
Level of Evidence: C.
Recommendations considering donor metabolism:27,30,32, 33, 34- Sally MB
- Ewing T
- Crutchfield M
- et al.
Determining optimal threshold for glucose control in organ donors after neurologic determination of death: A United Network for Organ Sharing Region 5 Donor Management Goals Workgroup prospective analysis.J Trauma Acute Care Surg. 2014; 76 (discussion 68-69): 62-68
- Sally MB
- Ewing T
- Crutchfield M
- et al.
Determining optimal threshold for glucose control in organ donors after neurologic determination of death: A United Network for Organ Sharing Region 5 Donor Management Goals Workgroup prospective analysis.
J Trauma Acute Care Surg. 2014; 76 (discussion 68-69): 62-68
Class IIa
- 1.Use of hearts from donors with moderately abnormal serum sodium (outside the 135-145 mEq/liter range) may be considered. Level of Evidence: C.
- 2.Hearts from donors with extreme hypo- or hypernatremia (serum sodium <129 or ≥170 mEq/liter, respectively) should not be used. Level of Evidence: C.
- 3.Donor hyperglycemia should not be a contraindication to use for heart transplantation. Level of Evidence: C.
Mechanisms of donor death
The mode of brain death affects clinical outcomes following heart transplantation.
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Recommendations are provided for donor death by carbon monoxide (CO) poisoning, explosive brain death, and unexplained causes. Furthermore, the pathophysiology of brain death includes neurohormonal and inflammatory changes that may result in donor organ injury. Beneficial effects of corticosteroid administration to brain-dead donors (hormonal resuscitation therapy) in terms of organ recovery, graft survival, and graft function have been reported, but there are many confounding factors that preclude definitive assessment of the utility of steroid administration during donor management.3
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Recommendations regarding donor death by CO poisoning:38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48
Class IIa
- 1.Donors with CO poisoning should be carefully screened. Risk factors for early heart allograft dysfunction include ischemic electrocardiogram (ECG) changes, troponin I elevations ≥0.7 ng/ml and left ventricular dysfunction. Level of Evidence: C.
Class III
- 1.Donors with CO poisoning and carboxyhemoglobin levels >40%, ischemic ECG changes, elevated levels of cardiac troponin (≥0.7 ng/ml) or ventricular dysfunction should generally be avoided. Level of Evidence: C.
Recommendation regarding explosive brain death: 23,35, 36, 37,49, 50, 51, 52, 53
Class IIa
- 1.Donors with explosive brain death may be considered for transplantation. There is evidence suggesting reduced long-term survival of recipients of such donors, possibly due to increased cardiac allograft vasculopathy. Level of Evidence: C.
Unexplained cause of donor death
Few reports have been published detailing the outcomes of allografts taken from donors with an unexplained cause of death. When faced with such an offer, centers should consider the more common causes of sudden death in young persons.
Recommendation for the evaluation of unexplained causes of death
Class IIb
- 1.Donors with unexplained cause of sudden death should be carefully screened with ECG and, when appropriate, coronary angiography for cardiac causes of death including hypertrophic cardiomyopathy, long-QT syndrome, Brugada syndrome, and congenital heart disease includes coronary anomalies. Donors with unexplained sudden death can be considered for transplant if the evaluation is negative. Level of Evidence: C.
Donor demographics
Recommendations for donor age:54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70
Class I
- 1.The use of donor hearts <45 years of age is recommended. Level of Evidence: C.
- 2.Donors ≥45 years of age can be used after screening for significant coronary artery disease (e.g., ≤50% narrowing) and if short ischemic times (<4 hours) can be expected. Such screening criteria vary around the world based on risk factors and average population donor characteristics. Considerations should take into account estimated survival benefit, availability of organs, the severity of illness of the recipient, and whether the recipient is on mechanical circulatory support. No established upper age limit currently exists. Level of Evidence: C.
Class IIa
- 1.Donor selection should account for unique recipient characteristics such as older donors to be used in older or highly sensitized recipients (smaller compatible donor pool) who have a negative crossmatch (either prospective or virtual depending on needs of recipient and/or institution) to the prospective older donor. Level of Evidence: C.
Donor size
Factors considered in developing guidelines on donor size were sex matching,
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donor weight and height,64
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predicted heart mass (pHM),63
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the role of body mass index,75
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oversizing for pulmonary hypertension,76
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and extreme donor-recipient size mismatch.63
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While there currently is no consensus as to best method of determining size matching, pHM is gaining in popularity.Recommendations regarding donor size
Class I
- 1.Allocation of female donors to male recipients may be done safely, especially in recipients without pulmonary hypertension and when adequate donor/recipient weight ratio and/or pHM are ensured. A value of pHM within 20% to 30% of recipient is considered acceptable. Level of Evidence: C.
Class IIb
- 1.Due to the impact on right ventricular dysfunction of the donor allograft, pulmonary hypertension in the intended recipient should be taken into consideration when determining the degree of acceptable size and sex mismatch. Level of Evidence: C.
Recommendation on anti-human leukocyte antigens (HLA) compatibility: 68,75,76,84
Class IIa
- 1.The presence of preformed human leukocyte antigens (HLA) antibodies should be ascertained and compared against the donor HLA, at least virtually, prior to acceptance for organ transplant. Level of Evidence: C.
- 2.There currently is no agreed-upon standard for which HLA antibodies can be crossed and which should be avoided. Center practice varies based on magnitude, strength of antibodies, whether they are C1q positive (e.g., complement-fixing), and the level of experience with managing sensitization and ability to absorb transplant center risk. Level of Evidence: C.
Recommendations on blood group compatibility between donor and recipient: 75,85, 86, 87
(See also Table 1.)
Table 1Compatible Blood Groups
| Recipient blood type | Compatible donor |
|---|---|
| A | A, O |
| B | B, O |
| AB | A, B, AB, O |
| O | O |
Class I
- 1.ABO blood group compatibility should be confirmed. Level of Evidence: C.
- 2.Systems of care should be implemented to assure that blood group compatibility is not violated without a specific reason (ABO-incompatible pediatric transplantation). Level of Evidence: C.
Recommendations regarding ischemic time:59,62,68,88, 89, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99, 100, 101, 102, 103, 104, 105, 106, 107, 108, 109
Class I
- 1.Target total organ ischemic time for cardiac transplantation should be ≤4 hours, to reduce the risk of primary graft dysfunction and early death. Level of Evidence: C.
Class IIa
- 1.A transplant center may allow the total organ ischemic time to exceed 4 hours for donors <45 years of age without compromising early outcomes after heart transplantation. With older donors, it is specifically recommended to avoid long-distance transportation or other factors (e.g., redo sternotomy, ventricular assist device (VAD) explantation, which can cause prolonged operative times) that could result in total donor ischemic times >4 hours. Level of Evidence: C.
- 2.Ex-vivo normothermic heart perfusion platforms can be safely used to decrease ischemic time for distant procurements and potentially to expand the procurement of marginal donors based on metabolic evaluation during ex-vivo perfusion. Level of Evidence: C.
Donor comorbidities
Recommendations for left ventricular hypertrophy (LVH)55,59,81,106,110, 111, 112, 113, 114, 115 and hypertension: 54,68,113,116Eurotransplant. Annual report. 2017; http://www.eurotransplant.org/wp-content/uploads/2019/12/Annual-Report-2017-HR.pdf.
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Eurotransplant. Annual report. 2017; http://www.eurotransplant.org/wp-content/uploads/2019/12/Annual-Report-2017-HR.pdf.
(See Table 2 for the gradation of left ventricular hypertrophy (LVH).)
Table 2LVH Determined by Measurement of the Interventricular Septum
| Level of LVH | Intraventricular septum |
|---|---|
| Mild | 11-13 mm |
| Moderate | 14-16 mm |
| Severe | ≥17 mm |
Class I
- 1.LVH should be assessed by measuring the thickness of the interventricular septum or the posterior wall on echocardiography. Level of Evidence: C.
Class IIa
- 1.Carefully selected donor hearts with LVH >13 mm (measured as outlined above) may be considered, particularly with younger (donors ≤40 years of age) and/or shorter ischemic time (<4 hours). Level of Evidence: C.
- 2.Chronic hypertension (defined by contemporary guidelines) or the use of hearts from donors being treated for hypertension in the absence of LVH do not appear to impact post-transplant outcomes. Level of Evidence: C.
Recommendations regarding donors with coronary artery disease (CAD): 55,118, 119, 120, 121, 122, 123, 124
(Table 3 illustrates how recommendations have varied over time and across geographic regions.)
Table 3Recommended Age Criteria for the Use of Coronary Angiography in Donor Evaluation Across Time and Geographic Region (Class IIa/b; Level of Evidence: C)
| Publication | Recommended age for men | Recommended age for women | Region | Year |
|---|---|---|---|---|
| ACCRecommendations 125 | • Age >45 years • Lower by 5-10 years if risk factors present | • Age >50 years • Lower by 5-10 years if risk factors present | US | 1993 |
| Maximizing Use of Organs Recovered From the Cadaver Donor Consensus Conference 27 | • Age >55 years: mandatory • Age >45 years: recommended • Age >35 years if cocaine or 3 risk factors | • Age >55 years: mandatory • Age >50 years: recommended • Age >40 years if cocaine or 3 risk factors | US | 2002 |
| United Network for Organ Sharing 126 | • Age >40 years • Younger with risk factors | • Age >45 years • Younger with risk factors | US | 2018 |
| European Committee on Organ Transplantation (Council of Europe) 127 | • Age >55 years • Age >45 years if more than 1 risk factor present | • Age >55 years • Age >45 years if more than 1 risk factor present | Europe | 2018 |
Class IIa
- 1.Donors with mild luminal irregularities (e.g., ≤50% narrowing) on coronary angiography may be considered for heart transplantation. Level of Evidence: C.
- 2.Coronary angiography should be considered in donors ≥45 years old, depending on geography and other risk factors. See also Table 3. Level of Evidence: C.
- 3.Risk factors suggesting need for coronary angiography include hypertension, diabetes (particularly with longer time of treatment), male sex, obesity, hyperlipidemia, tobacco and/or cocaine/methamphetamine use. Level of Evidence: C.
- 4.Myocardial bridging is rarely a contraindication to transplantation. Level of Evidence: C
Class IIb
- 1.Donors with single-vessel coronary disease amenable to percutaneous or surgical therapy may be considered after balancing the risk of coronary disease progression and the urgency of the recipient. Level of Evidence: C.
- 2.Donors with left main and/or 2 to 3 vessel obstructive (≥50%) coronary disease are best avoided for transplantation in the absence of extenuating circumstances. Level of Evidence: C.
Recommendations regarding donors with diabetes:54,55,58,59,68,69,81,116Eurotransplant. Annual report. 2017; http://www.eurotransplant.org/wp-content/uploads/2019/12/Annual-Report-2017-HR.pdf.
,117,128, 129, 130, 131- Joseph JT
- Mulvihill MS
- Yerokun BA
- Bell SM
- Milano CA
- Hartwig MG.
Elevated donor hemoglobin A1c does not impair early survival in cardiac transplant recipients [e-pub ahead of print].Clin Transplant. 2017; 31https://doi.org/10.1111/ctr.12995
Eurotransplant. Annual report. 2017; http://www.eurotransplant.org/wp-content/uploads/2019/12/Annual-Report-2017-HR.pdf.
- Joseph JT
- Mulvihill MS
- Yerokun BA
- Bell SM
- Milano CA
- Hartwig MG.
Elevated donor hemoglobin A1c does not impair early survival in cardiac transplant recipients [e-pub ahead of print].
Clin Transplant. 2017; 31https://doi.org/10.1111/ctr.12995
Class IIa
- 1.Donors with diabetes mellitus and no other risk factors, particularly without coronary artery disease, can be safely used. Level of Evidence: C.
- 2.Coronary angiography should be considered for diabetic donors, and duration of diabetes and donor age should be carefully weighed. Level of Evidence: C.
Recommendations regarding donor experiencing cardiopulmonary arrest and the duration of cardiopulmonary resuscitation (CPR): 132, 133, 134, 135, 136, 137, 138
Class IIa
- 1.Donors with cardiopulmonary resuscitation may be used if heart function is normal (by left ventricular ejection fraction (LVEF) and hemodynamics) at the time of procurement, unless the cardiac arrest circumstances raise the suspicion for underlying structural heart disease. Level of Evidence: C.
- 2.The duration of donor cardiopulmonary arrest and of the CPR alone should not be used to exclude donor hearts for transplantation. CPR times >30 minutes in both adult and pediatric donors do not negatively impact post-transplant survival or outcomes if echocardiographic cardiac function and hemodynamics are favorable (e.g., LVEF >50%) after resuscitation. Level of Evidence: C.
Donor drug use
Recommendation regarding donor tobacco use: 139, 140, 141, 142, 143, 144
Class IIa
- 1.Tobacco use of significant pack-years increases the risk of donor coronary artery disease (CAD). Depending on donor age (>45 years), obtaining a donor angiogram may be reasonable. Level of Evidence: C.
Recommendation regarding donor alcohol use: 145, 146, 147, 148, 149, 150, 151, 152- Peled Y
- Varnado S
- Lowes BD
- et al.
Sinus tachycardia is associated with impaired exercise tolerance following heart transplantation [e-pub ahead of print].Clin Transplant. 2017; 31https://doi.org/10.1111/ctr.12946, 153
- Peled Y
- Varnado S
- Lowes BD
- et al.
Sinus tachycardia is associated with impaired exercise tolerance following heart transplantation [e-pub ahead of print].
Clin Transplant. 2017; 31https://doi.org/10.1111/ctr.12946
Class IIa
- 1.The hearts of donors with a history of alcohol use may be used for transplantation if cardiac function is preserved on echocardiography. Level of Evidence: C.
Recommendations regarding donor use of illicit drugs (cocaine, amphetamine, methamphetamine): 140,154, 155, 156, 157, 158- Lansinger JT
- Long A
- Barreiro C
- et al.
Donors and Drugs: How Often Do They Mix? Utilization of Donors Based on Toxicology Findings [e-pub ahead of print].Am J Transplant. 2019; 19https://doi.org/10.1161/CIRCHEARTFAILURE.122.009547, 159, 160
- Lansinger JT
- Long A
- Barreiro C
- et al.
Donors and Drugs: How Often Do They Mix? Utilization of Donors Based on Toxicology Findings [e-pub ahead of print].
Am J Transplant. 2019; 19https://doi.org/10.1161/CIRCHEARTFAILURE.122.009547
Class IIa
- 1.Donors with a history of cocaine use can be considered for heart transplantation if there is no significant LVH (i.e., ≥14 mm; see also the recommendations on donor LVH in this document). Level of Evidence: C.
- 2.Donors with a history of past or active cocaine use should have a coronary angiogram when possible. Level of Evidence: C.
- 3.Donors with toxicology positive for amphetamine or methamphetamine may be utilized for transplant if ventricular function and structure are normal on echocardiogram and imaging. Level of Evidence: C.
- 4.Donors with toxicology positive for multiple substances may be utilized for transplant if ventricular function and structure are normal on echocardiogram and imaging. Level of Evidence: C.
Infections in the donor
This section reviews various potential infections in a donor though it is not comprehensive of all possibilities. Infectious disease thoracic transplant physician specialists should be consulted for unique donor infections as new pathogens are always emerging and treatments are constantly evolving.
Recommendation regarding bacterial infections in the donor: 63,161, 162, 163, 164, 165
Class IIa
- 1.Transplantation of hearts from bacteremic donors is feasible, provided that the recipient, after being informed of the associated risks, is treated with targeted antimicrobials for an appropriate duration post-transplant. Level of Evidence: C.
Recommendations regarding fungal infections: 166, 167, 168, 169- Gajurel K
- Dhakal R
- Deresinski S.
Histoplasmosis in transplant recipients [e-pub ahead of print].Clin Transplant. 2017; 31https://doi.org/10.1111/ctr.13087, 170- Nelson JK
- Giraldeau G
- Montoya JG
- Deresinski S
- Ho DY
- Pham M.
Donor-Derived Coccidioides immitis Endocarditis and Disseminated Infection in the Setting of Solid Organ Transplantation [e-pub ahead of print].Open Forum Infect Dis. 2016; 3https://doi.org/10.1093/ofid/ofw086, 171, 172, 173
- Gajurel K
- Dhakal R
- Deresinski S.
Histoplasmosis in transplant recipients [e-pub ahead of print].
Clin Transplant. 2017; 31https://doi.org/10.1111/ctr.13087
- Nelson JK
- Giraldeau G
- Montoya JG
- Deresinski S
- Ho DY
- Pham M.
Donor-Derived Coccidioides immitis Endocarditis and Disseminated Infection in the Setting of Solid Organ Transplantation [e-pub ahead of print].
Open Forum Infect Dis. 2016; 3https://doi.org/10.1093/ofid/ofw086
(See Table 4.)
Table 4Fungal Infections
| Pathogen | Recommendation | Strength/level of evidence |
|---|---|---|
| Aspergillus, active | If disseminated, do not utilize | III /C |
| Aspergillus, active (lung only) | If lung only, consider taking heart with post-transplant prophylaxis | IIb /C |
| Aspergillus, history of disease | If findings, send workup to rule out active disease, possible post-transplant prophylaxis | IIa /C |
| Coccidiomycosis, active disease | Do not utilize | III /C |
| Coccidiomycosis, history of disease | If findings, send workup to rule out active disease, possible post-transplant prophylaxis | IIa /C |
| Cryptococcus, untreated | Do not utilize | III /C |
| Cryptococcus, actively treated | Consider risks/benefits | IIa /C |
| Histoplasmosis, active disease | Do not utilize | III /C |
| Histoplasmosis, history of disease | If findings, send workup to rule out active disease | IIa /C |
Recommendations regarding bloodborne viral infections in the donor
(Recommendations concerning donors with hepatitis B,
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, Organ Procurement and Transplantation Network. Policy 1: Administrative rules and definitions. 2021; https://optn.transplant.hrsa.gov/media/1200/optn_policies.pdf.
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hepatitis C,189
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and human immunodeficiency virus (HIV)199
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are summarized in Table 5.)Table 5Bloodborne Infections
| Pathogen | Recommendation | Strength/level of evidence |
|---|---|---|
| Hepatitis B Ag+ | Should be limited to carefully selected, consented recipients. | IIa /C |
| Hepatitis B cAb+ | With appropriate post-transplant monitoring and prophylaxis, HBcAb+ donor organs may be used for transplantation. | IIa /C |
| Hepatitis C (anti-HCV+, HCV-RNA-) | Generally safe for transplantation but requires post-transplant HCV-RNA monitoring. | IIa /C |
| Hepatitis C (anti-HCV+, HCV RNA+) | Should be limited to consented recipients with appropriate post-transplant treatment and monitoring. | IIa /C |
| HIV | Transplantation of HIV seropositive hearts into HIV seropositive recipients is reasonable with full informed consent and involvement of local infectious disease experts in advance. | IIa /C |
Recommendation regarding donors with tuberculosis:208
(See Table 6.)
Table 6Recommendation Regarding Donors with Tuberculosis
| Pathogen | Recommendation | Strength/level of evidence |
|---|---|---|
| Mycobacterium tuberculosis, active disease | Consider taking organ, consult infectious disease specialist for follow up and isonicotinic acid hydrazide (INH) for 6 months | IIb /C |
| Mycobacterium tuberculosis, history of disease | Accept organ, consult infectious disease specialist for follow up and consider INH 3-6 months | IIa /C |
Recommendation regarding donors with increased infection risk:127,193,209, 210, 211- Green M
- Covington S
- Taranto S
- et al.
Donor-derived transmission events in 2013: a report of the organ procurement transplant network ad hoc disease transmission advisory committee.Transplantation. 2015; 99: 282-287
- Green M
- Covington S
- Taranto S
- et al.
Donor-derived transmission events in 2013: a report of the organ procurement transplant network ad hoc disease transmission advisory committee.
Transplantation. 2015; 99: 282-287