Table 2.
Indications for listing for heart transplantation in accordance with ISHLT 2016 criteria 7
Cardiopulmonary stress testing to guide transplant listing: a maximal cardiopulmonary exercise test is defined as one with a respiratory exchange ratio (RER) of 1.05 and achievement of an anaerobic threshold on optimal pharmacological therapy (Class I, level of evidence: B) |
In patients intolerant of a beta‐blocker, a cut‐off for peak oxygen consumption (VO2) of 14 mL/kg/min should be used to guide listing (Class I, level of evidence: B) |
In the presence of a beta‐blocker, a cut‐off for peak VO2 of 12 mL/kg/min should be used to guide listing (Class I, level of evidence: B) |
In young patients (<50 years) and women, it is reasonable to consider using alternate standards in conjunction with peak VO2 to guide listing, including per cent of predicted (50%) peak VO2 (Class IIa, level of evidence: B) |
In the presence of a sub‐maximal cardiopulmonary exercise test (RER 1.05), use of ventilation equivalent of carbon dioxide (VE/VCO2) slope of >35 as a determinant in listing for transplantation may be considered (Class IIb, level of evidence: C) |
In obese [body mass index (BMI) >30 kg/m2] patients, adjusting peak VO2 to lean body mass may be considered. A lean body mass‐adjusted peak VO2 of 19 mL/kg/min can serve as an optimal threshold to guide prognosis (Class IIb, level of evidence: B) |
Listing patients based solely on the criterion of a peak VO2 measurement should not be performed (Class III, level of evidence: C) |
Use of heart failure prognosis scores: heart failure prognosis scores should be performed along with cardiopulmonary exercise test to determine prognosis and guide listing for transplantation for ambulatory patients. An estimated 1 year survival as calculated by the Seattle Heart Failure Model (SHFM) of 80% or a Heart Failure Survival Score (HFSS) in the high/medium‐risk range should be considered as reasonable cut points for listing (Class IIb, level of evidence: C) |
Listing patients solely on the criteria of heart failure survival prognostic scores should not be performed (Class III, level of evidence: C) |
Role of diagnostic right heart catheterization (RHC): RHC should be performed on all adult candidates in preparation for listing for cardiac transplantation and periodically until transplantation (Class 1, level of evidence: C). Periodic RHC is not advocated for routine surveillance in children (Class III, level of evidence: C) |
RHC should be performed at 3 to 6 month intervals in listed patients, especially in the presence of reversible pulmonary hypertension or worsening of heart failure symptoms (Class I, level of evidence: C) |
A vasodilator challenge should be administered when the pulmonary artery systolic pressure is >50 mmHg and either the transpulmonary gradient is >15 or the pulmonary vascular resistance (PVR) is >3 Wood units while maintaining a systolic arterial blood pressure >85 mmHg (Class I, level of evidence: C) |
When an acute vasodilator challenge is unsuccessful, hospitalization with continuous haemodynamic monitoring should be performed, as often the PVR will decline after 24 to 48 h of treatment consisting of diuretics, inotropes, and vasoactive agents such as inhaled nitric oxide (Class I, level of evidence: C) |
If medical therapy fails to achieve acceptable haemodynamics and if the left ventricle cannot be effectively unloaded with mechanical adjuncts, including an intra‐aortic balloon pump (IABP) and/or left ventricular assist device (LVAD), it is reasonable to conclude that the pulmonary hypertension is irreversible. After LVAD, re‐evaluation of haemodynamics should be performed after 3 to 6 months to ascertain reversibility of pulmonary hypertension (Class IIA, level of evidence: C) |
Carefully selected patients 4–70 years of age may be considered for cardiac transplantation (Class IIb, level of evidence: C) |
Pre‐transplant body mass index (BMI) >35 kg/m2 is associated with a worse outcome after cardiac transplantation. For such obese patients, it is reasonable to recommend weight loss to achieve a BMI of <35 kg/m2 before listing for cardiac transplantation (Class IIa, level of evidence: C) |
Pre‐existing neoplasms are diverse, and many are treatable with excision, radiotherapy, or chemotherapy to induce cure or remission. In these patients needing cardiac transplantation, collaboration with oncology specialists should occur to stratify each patient as to their risk of tumour recurrence. Cardiac transplantation should be considered when tumour recurrence is low based on tumour type, response to therapy, and negative metastatic work‐up. The specific amount of time to wait to transplant after neoplasm remission will depend on the aforementioned factors, and no arbitrary time period for observation should be used (Class I, level of evidence: C) |
Diabetes with end‐organ damage (other than non‐proliferative retinopathy) or persistent poor glycaemic control [glycosylated haemoglobin (HbA1c) >7.5% or 58 mmol/mol] despite optimal effort is a relative contraindication for transplant (Class IIa, level of evidence: C) |
Renal function should be assessed using estimated glomerular filtration rate (eGFR) or creatinine clearance under optimal medical therapy. Evidence of abnormal renal function should prompt further investigation, including renal ultrasonography, estimation of proteinuria, and evaluation for renal arterial disease, to exclude intrinsic renal disease. It is reasonable to consider the presence of irreversible renal dysfunction (eGFR <30 mL/min/1.73 m2) as a relative contraindication for heart transplantation alone (Class IIa, level of evidence: C) |
Clinically severe symptomatic cerebrovascular disease may be considered a contraindication to transplantation. Peripheral vascular disease may be considered a relative contraindication for transplantation when its presence limits rehabilitation and revascularization is not a viable option (Class IIb, level of evidence: C) |
Assessment of frailty (3 of 5 possible symptoms, including unintentional weight loss of >10 lbs within the past year, muscle loss, fatigue, slow walking speed, and low levels of physical activity) could be considered when assessing candidacy (Class IIb, level of evidence: C) |
Use of mechanical circulatory support should be considered for patients with potentially reversible or treatable co‐morbidities, such as cancer, obesity, renal failure, tobacco use, and pharmacologically irreversible pulmonary hypertension, with subsequent re‐evaluation to establish candidacy (Class IIb, level of evidence: C) |
Tobacco use: education on the importance of tobacco cessation and reduction in environmental or second‐hand exposure should be performed before the transplant and continue throughout the pre‐transplant and post‐transplant periods (Class I, level of evidence: C) |
It is reasonable to consider active tobacco smoking as a relative contraindication to transplantation. Active tobacco smoking during the previous 6 months is a risk factor for poor outcomes after transplantation (Class IIa, level of evidence: C) |
A structured rehabilitative programme may be considered for patients with a recent (24 month) history of alcohol abuse if transplantation is being considered (Class IIb, level of evidence: C) |
Patients who remain active substance abusers (including alcohol) should not receive heart transplantation (Class III, level of evidence: C) |
Psychosocial assessment should be performed before listing for transplantation. Evaluation should include an assessment of the patient's ability to give informed consent and comply with instruction, including drug therapy, as well as assessment of the support systems in place at home or in the community (Class I, level of evidence: C) |
Any patient for whom social supports are deemed insufficient to achieve compliant care in the outpatient setting may be regarded as having a relative contraindication to transplant. The benefit of heart transplantation in patients with severe cognitive–behavioural disabilities or dementia (e.g. self‐injurious behaviour and inability to ever understand and cooperate with medical care) has not been established and has the potential for harm, and therefore, heart transplantation cannot be recommended for this subgroup of patients (Class IIa, level of evidence: C) |
Poor compliance with drug regimens is a risk factor for graft rejection and mortality. Patients who have demonstrated an inability to comply with drug therapy on multiple occasions should not receive transplantation (Class III, level of evidence: C) |
Listed patients in an outpatient, ambulatory, non‐inotropic therapy‐dependent state should be continually evaluated for maximal pharmacological and device therapy, including implantable cardioverter defibrillator (ICD) or biventricular pacing, when appropriate. Such patients must be re‐evaluated at 3 to 6 month intervals with cardiopulmonary exercise testing and heart failure survival prognostic scores to assess their response to therapy and, if they have improved significantly, should be considered for delisting (Class I, level of evidence: C) |
Higher prioritization for highly sensitized patients may be considered due to difficulty obtaining a donor, causing excessive waiting times and an increase in waiting list mortality (Class IIb, level of evidence: C) |
Retransplantation is indicated for those patients who develop significant CAV with refractory cardiac allograft dysfunction, without evidence of ongoing rejection (Class IIa, level of evidence: C) |
CAV, cardiac allograft vasculopathy.