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...................................................... prospective trial, Early-VAD (ClinicalTrials.gov Identifier: NCT02387112). Also, the Swedish evaluation of LVAD (SweVAD) study is comparing the survival of patients with advanced HF ineligible for heart transplantation prospectively randomized to LVAD as DT vs. MT (ClinicalTrials.gov Identifier: NCT02592499).410

10.2.3 Heart transplantation Heart transplantation remains the gold standard for the treatment of advanced HF in the absence of contraindications. Post-transplant 1year survival is around 90% with a median survival of 12.5 years.385,411,412 Transplantation significantly improves QOL and functional status, although, for unclear reasons, the percentage of patients returning to work is lower than expected.412 Apart from primary graft dysfunction, the main challenges after heart transplantation relate to either the efficacy or side effects of immunosuppression (e.g. rejection, infection, cardiac allograft vasculopathy, late graft dysfunction, malignancy, renal failure, hypertension, diabetes mellitus). Organ donor shortage remains the main limitation to heart transplantation. Thus, the donor heart criteria have now been extended to allow an increased upper limit of the donor age, particularly in Europe. Moreover, careful recipient selection is needed, based on pre-transplant and post-transplant life expectancy (both are influenced by pre-operative status and comorbidities).

The main indications and contraindications for heart transplantation are listed in Table 17.376,385 Active infection is a relative contraindication to transplant but in some cases of infected LVADs it may actually be an indication. Elderly age is not an absolute contraindication. Although patients aged <65 years might be more appropriate candidates due to their overall life expectancy, most programmes accept patients up to 70 years of age, and biological age as well as chronological age must be taken into account. Surgical complexity [previous sternotomies, mediastinal radiation, adult congenital heart disease (ACHD)] should also be considered. The decision pathway to transplantation or LVAD is never straightforward and is unique to each patient. Eligibility for each option may change according to the particular conditions of each patient, which may also change over time. Other factors, not related to the patient, such as time on the heart transplant waiting list, the

Table 17 Heart transplantation: indications and contraindications

Indications Advanced HF376 No other therapeutic option, except for LVAD as BTT Contraindications Active infectiona Severe peripheral arterial or cerebrovascular disease Pharmacologic irreversible pulmonary hypertension (LVAD should be considered to reverse elevated pulmonary vascular resistance with subsequent re-evaluation to establish candidacy) Malignancy with poor prognosis (a collaboration with oncology specialists should occur to stratify each patient as regards their risk of tumour progression or recurrence which increases with the use of immunosuppression) Irreversible liver dysfunction (cirrhosis) or irreversible renal dysfunction (e.g. creatinine clearance <30 mL/min/1.73 m2). Combined heart-liver or heart-kidney transplant may be considered Systemic disease with multiorgan involvement Other serious comorbidity with poor prognosis Pre-transplant BMI >35 kg/m2 (weight loss is recommended to achieve a BMI <35 kg/m2) Current alcohol or drug abuse Psychological instability that jeopardizes proper follow-up and intensive therapeutic regime after heart transplantation Insufficient social supports to achieve compliant care in the outpatient setting BMI = body mass index; BTT = bridge to transplantation; HF = heart failure; LVAD = left ventricular assist device. aActive infection is a relative contraindication to transplant although in some cases of infected LVADs it may actually be an indication. Adapted from Crespo-Leiro et al.376 Recommendations for the treatment of patients with advanced heart failure

Recommendations Classa Levelb

Patients being considered for long-term MCS must have good compliance, appropriate capacity for device handling and psychosocial support.414416 I C Heart transplantation is recommended for patients with advanced HF, refractory to medical/device therapy and who do not have absolute contraindications. I C Long-term MCS should be considered in patients with advanced HFrEF despite optimal medical and device therapy, not eligible for heart transplantation or other surgical options, and without severe right ventricular dysfunction, to reduce the risk of death and improve symptoms.378,396,397,401,402,404,417 IIa A Long-term MCS should be considered in patients with advanced HFrEF refractory to optimal medical and device therapy as a bridge to cardiac transplantation in order to improve symptoms, reduce the risk of HF hospitalization and the risk of premature death.398400,402,404 IIa B Renal replacement therapy should be considered in patients with refractory volume overload and end-stage kidney failure. IIa C Continuous inotropes and/or vasopressors may be considered in patients with low cardiac output and evidence of organ hypoperfusion as bridge to MCS or heart transplantation.389,390 IIb C Ultrafiltration may be considered in refractory volume overload unresponsive to diuretic treatment.391,392 IIb C

HF = heart failure; HFrEF = heart failure with reduced ejection fraction; MCS = mechanical circulatory support. aClass of recommendation. bLevel of evidence.

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