A roadmap for evaluating the use and value of durable ventricular assist device therapy.

Heart failure is a disease characterized by profound human suffering with limitations in survival despite treatment with guideline-directed medical therapies. Patients with heart failure frequently progress to advanced stages and often require cardiac transplantation or implantation of left ventricular assist devices (LVADs) to extend survival and improve quality of life. As the number of suitable heart donors, number of experienced medical centers and patient comorbidities place restrictions on the feasibility of cardiac transplantation, implantation of LVADs has emerged as a more frequently applied treatment as either a bridge to transplantation or as permanent therapy. Considerable data have documented improvements in survival, functional status and quality of life offered by LVADs, however, few studies have focused on identifying: (1) determinants of LVAD use across medical centers, (2) the relationship between the determinants of LVAD use and value (defined as quality divided by cost), and (3) how determinants of LVAD use are influenced or impacted by vulnerable populations. We propose a conceptual model that integrates the main determinants of LVAD utilization, which include technology, insurance coverage, market-, provider- and patient-level factors. We propose this paradigm as a necessary prerequisite for understanding LVAD usage and value. This conceptual framework provides a broader view for future studies, which are needed to inform emerging healthcare policies that influence dissemination of this expensive but life-prolonging medical therapy.