Mycophenolate mofetil (MMF) represents a cornerstone in heart transplant (HTx) treatment. The area under the 12-hour concentration-time curve (AUC0-12h) of mycophenolic acid (MPA) -MMF’s active drug- is associated with treatment outcome. Nonetheless, therapeutic drug monitoring (TDM) of MPA AUC0-12h is impractical to assess in clinical practice and Limited Sampling Strategies (LSSs) represent a consolidated tool to estimate AUC0-12h. Two LSSs were previously generated in a selected cohort of HTx recipients treated with MMF and cyclosporine (CsA). This pilot study aimed to test these LSSs in a cohort of non-selected HTx recipients treated with MMF combined with CsA or tacrolimus (TAC). Complete PK profile was performed in 40 adults HTx recipients. MPA-AUC0-12h was estimated by two algorithms, LSS3 and LSS4, based on 3 and 4 time-points. The evaluation was made through linear regression and Bland-Altman analyses. Both LSS3 and LSS4 tended to underestimate the value of MPA-AUC0-12h (mean percentage prediction error, MPE%: −6.0%; and −4.8%, respectively). Nonetheless, high correlations (r: 0.92 and 0.94, respectively) and goodness of fit of linear regression models (R2: 0.84 and 0.88, respectively) emerged for both LSSs. A study with a wider and more homogenous sample size should be performed to support these results.
Part of the book: Heart Transplantation
Extracorporeal membrane oxygenation (ECMO) is increasingly employed to support patients affected by refractory cardiogenic shock. When patients cannot be weaned from ECMO because of severe heart dysfunction, heart transplantation (HTx) or implantation of a durable mechanical circulatory support should be considered. Traditionally, the use of ECMO as a direct bridge to HTx was burdened by high mortality. However, during these last years, the widespread employment of ECMO increased centers’ experience in the management of this device, and new allocation policies provided the highest priority level for ECMO HTx candidates. Therefore, these factors could have mitigated the negative outcomes previously reported. The aim of this chapter is to describe the role of ECMO as a direct bridge to HTx, analyzing results of this strategy, and how to determine candidacy and risk stratification among the severely ill population of patients supported by this mechanical circulatory support.
Part of the book: Extracorporeal Membrane Oxygenation Support Therapy