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The International Society of Heart and Lung Transplantation Guidelines for the Care of Heart Transplant Recipients

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The International Society of Heart and Lung Transplantation Guidelines for the Care of Heart Transplant Recipients ISHLT Guidelines for the Care of Heart Transplant Recipients Task Force 3 The international society of heart and lung transplantation guidelines for the care of heart transplant recipients TASK FORCE 3: Long-term Care of Heart Transplant Recipients (Aug. 6, 2010) Chair: Sharon Hunt, MD; Co-Chair: Michael Burch Contributing Writers: Geetha Bhat, MD; Charles Canter, MD; Richard Chinnock, MD; Marisa Crespo-Leiro, MD; Reynolds Delgado, MD; Fabienne Dobbels, PhD; Kathleen Grady, PhD; Walter Kao, MD; Jacqueline Lamour, MD; Gareth Parry, MD; Jignesh Patel, MD; Daniela Pini, MD; Jeffrey Towbin, MD; Gene Wolfel, MD More recently, randomization of low-risk HT recipients to Topic 1: Minimization of either an anti-thymocyte globulin (ATG)-based CS-avoidance Immunosuppression regimen or a long-term CS-based regimen without antibody 8 The principal goal of immunosuppressive therapy in heart induction showed that the 2 groups had similar rejection rates transplantation (HT) is to maintain a fine balance between with lower short-term morbidity in the CS-avoidance group. minimizing the risk of allograft rejection and minimizing the Further studies to demonstrate the long-term safety and long-term morbidity associated with the adverse effects of benefits of CS avoidance should be carried out. immunosuppressive drugs. Calcineurin Inhibitor Minimization Strategies for Minimization of Immunosuppression The cumulative incidence of chronic renal failure in HT recipients is estimated to be ≥ 10% at 5 years9 and has been Corticosteroid Minimization chiefly attributed to long-term calcineurin inhibitor (CNI) use. Because corticosteroid (CS) therapy is associated with In general, the highest doses of CNIs are used early post-HT glucose intolerance, dyslipidemia, hypertension, osteoporosis when the risk of rejection is the greatest followed by gradual and infection, minimizing its use after HT is highly desirable, reduction of CNI exposure thereafter. A number of trials have when safe. Patients at low risk of rejection, including those addressed the feasibility of CNI reduction or elimination in without circulating anti-human leukocyte antigen (HLA) HT.10-21 The use of mycophenolate mofetil (MMF) rather than antibodies, non-multiparous women, those without a history of azathioprine (AZA) has permitted successful lowering of CNI rejection, and older HT recipients may be considered for rapid exposure,22 with lower rates of rejection, improved renal CS weaning and withdrawal. In HT, a higher number of HLA function, and increased CS weaning. In a prospective, mismatches is predictive of adverse outcomes with CS multicenter study,11 substitution of AZA with MMF before 1 weaning. Therefore, the degree of immuno-incompatibility cyclosporine (CYA) dose reduction resulted in a significant should be considered when individualizing CS treatment decrease in serum creatinine (sCr) in the intervention arm strategies. compared to a modest increase in the control group. Reduction Early withdrawal of prednisone during the first month of of CYA was also associated with a significant decrease in HT in recipients of cytolytic induction therapy has been blood pressure. A number of smaller single-center studies 12, 13, 19 successful in 49% to 70% of patients.2-4 Because the majority have produced concordant results. of acute rejection episodes occur during the first 6 months Late CYA reduction in HT recipients without adjunctive after HT, CS withdrawal after this period can be achieved in therapy, however, appears not to be associated with renal 5, 6 up to 80% of cases, even without prior induction therapy. function improvement.18 The substitution of sirolimus (SRL) According to the most recent International Society of Heart for AZA also seems to be of limited benefit in the setting of and Lung Transplantation (ISHLT) Registry data, > 40% of CNI minimization, because these agents (proliferation signal 7 HT recipients are successfully maintained off CSs at 5 years. inhibitors [PSIs]) may exacerbate CNI nephrotoxicity.20, 23, 24 A standardized protocol for CS withdrawal, guided by serial The use of PSIs for the specific purpose of CNI minimization endomyocardial biopsy (EMB), is typically employed. to reduce nephrotoxicity remains controversial. 1 ISHLT Guidelines for the Care of Heart Transplant Recipients Task Force 3 Calcineurin Inhibitor Withdrawal allo-antibodies measurement after HT in guiding Late post-HT substitution of SRL for CNI21 or for MMF immunosuppression weaning has not yet been tested in and targeting lower CNI levels appears to be beneficial with prospective studies. respect to improvement in renal function and cardiac allograft Immunosuppression Minimization in Pediatric Heart 25 vasculopathy (CAV) without increasing rejection rates. Early Transplantation withdrawal of CNI with PSI substitution, however, has been Given the known effects of CSs on growth, early associated with unacceptably high rejection rates.14, 16, 26, 27 In withdrawal, minimization, or avoidance has long been a summary, while use of SRL without a CNI is not advisable prominent goal in pediatric immunosuppression protocols, early after HT, when the risk of rejection is highest and especially in infants.37-40 Current ISHLT pediatric data41 therapeutic immunosuppression with a CNI is of greatest shows that > 40% of pediatric patients are not on maintenance importance, substitution of the CNI may be a viable option CSs at 1 year after HT and this percentage increases to nearly late after HT in stable patients, in whom a significant 60% at 5 years after HT. improvement in renal function can be expected.14, 16, 26 As in adults, pediatric immunosuppression generally is Calcineurin Inhibitor Monotherapy achieved with a combination of a CNI and an anti-proliferative Very few studies have investigated the safety and efficacy agent. However, for several years some centers39 have of CNI monotherapy in HT recipients. A small study employed CNI monotherapy successfully in low-risk patients suggested the feasibility of initially using tacrolimus (TAC) such as infant HT recipients. MMF is increasingly being used with prednisone, with 75% of patients being subsequently in the pediatric population to allow for CS withdrawal and weaned off CSs with acceptable rejection and improved lower CNI levels.41 survival rates. A subsequent randomized trial without induction therapy and with early withdrawal of CSs revealed Because of differences in CYA absorption patterns in comparable rejection rates between triple regimen and pediatric patients, use of C2 levels for dose minimization is 42 monotherapy groups at 1 year but longer term results are problematic. Marked individual variations in the needed to determine the impact of this strategy on mortality, pharmacokinetics of MMF have also been observed in 43 rejection, renal function, CAV, and malignancy.28, 29 children. Shorter half-lives with more rapid metabolism have been observed in pediatric renal transplant patients taking SRL Monitoring without concomitant CNI.44 Thus, strategies aimed at Trough or pre-dose CNI levels are most commonly used immunosuppression minimization in children may require a (see Task Force 2, Topic 2: Monitoring of Immunosuppressive greater reliance on therapeutic drug level monitoring for Drug Levels), but there is some evidence that monitoring of individualization of drug dosing than is needed in adult CYA levels at 2 hours after dosing (C2) may be a better patients. indicator of immunosuppression efficacy than trough levels Recommendations for the Minimization of and may be associated with lower CNI exposure without 2, 6, 8, 11, 15, 17, 18, 20, 22, 23, 25, 29, 38, 44 30-32 Immunosuppression : adverse outcome and improved renal function. Exposure to MMF may be measured with trough mycophenolic acid Class I: (MPA) levels. However, the relationship between MPA levels 1. CS withdrawal can be successfully achieved 3 to and rejection remains unclear.33 6 months after HT in many low-risk patients (those without circulating anti-HLA antibodies, non-multiparous Pre-HT panel reactive antibodies (PRAs) have been women, those without a history of rejection, and older HT correlated with post-HT adverse outcomes in HT recipients.34, recipients). 35 Detection of anti-HLA antibodies by flow-cytometry both pre- and post-HT is more predictive of rejection compared Level of Evidence: B. with the complement-dependent cytotoxicity assay35 and 2. Lower levels of CNIs in HT recipients should be sought provides a useful marker that can be serially assessed during when CNIs are used in conjunction with MMF (compared minimization of immunosuppression. Quantitation of flow- to AZA) because with this combination lower levels are PRAs is also now possible with measurement of mean safe and associated with lower rejection rates as well as fluorescence intensities, which may further help stratify risk of improved renal function. rejection in patients with circulating antibodies. The presence Level of Evidence: B. of post-HT donor-specific antibodies is also a marker for the subsequent development of CAV.36 The usefulness of serial 2 ISHLT Guidelines for the Care of Heart Transplant Recipients Task Force 3 Class IIa: (including ischemic and hemorrhagic stroke), seizures, 1. A PSI may be substituted for CNI later than 6 months encephalopathy, central nervous system (CNS) infections, and 45-50 after HT to reduce CNI-related nephrotoxicity and CAV peripheral neuropathies. Headache, tremor, and insomnia in low risk recipients. are common in CNI-treated patients.
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