Abstract
Left ventricular assist devices (LVADs) have emerged as an important treatment for advanced heart failure (AHF). While LVAD support results in left ventricular reverse remodeling with evidence of improvement on cellular, molecular, and genetic levels, the recovery is partial and generally inadequate for device explant. This has prompted recent interest in the evaluation of adjunctive regenerative therapies, such as stem cells and gene therapy, with LVADs to explore the potential for synergistic effects of myocardial regeneration. This chapter discusses the opportunities and challenges of designing and conducting clinical trials evaluating biological therapies in AHF patients undergoing LVAD implantation. In particular, LVADs as a platform for evaluating adjunctive therapies, and the methodological and technical issues arising from this approach of combining biological treatments with LVADs will be explored.
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