Long-term continuous flow left ventricular assist device support and end-organ function: prospects for destination therapy.

Pulsatile flow left ventricular assist devices (PF-LVADs) have successfully supported patients with severe heart failure for bridge-to-transplant (BTT) and destination therapy (DT). End-organ dysfunction is often reversed, optimizing the patient's condition to enhance survival, and quality of life. Questions have been raised regarding the potential for continuous flow LVADs (CF-LVADs) to provide the same quality of circulatory support. Prior research showing that PF is superior to continuous, non-PF does not appear to be relevant with CF-LVADs for BTT and DT. Under most clinical conditions, arterial pulsatility is present during CF-LVAD support, and this type of support should not be termed "nonpulsatile." Clinical studies have shown that renal, hepatic, and neurocognitive function is either maintained within a normal range, or is significantly improved, during CF-LVAD support for durations up to 15 months. Results of the randomized clinical trial between the CF HeartMate II and the pulsatile HeartMate XVE (both by Thoratec Corp, Pleasanton, CA, USA) are pending final US Food and Drug Administration (FDA) review and are not yet published. Studies of microcirculation during CF-LVAD support indicate that capillary blood flow is adequate to support cellular function. There are anecdotal cases of patients being supported with a CF-LVAD for over seven years with preserved end-organ function. Presently, there are no clinical reports indicating that end-organ function is not well maintained. Current clinical evidence indicates that end-organ perfusion and function can be well maintained for extended durations of support with a CF-LVAD.

RCT Entities:   Population Interventions Outcomes