An evaluation of continuous-flow left ventricular assist devices and the incidence of stroke in patients awaiting heart transplantation
Turno, Douglas-Jarrett Cole
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Continuous-flow left ventricular assist devices provide mechanical circulatory assistance for patients suffering from end-stage heart failure that are awaiting or ineligible for heart transplantation. Although actuarial survival and quality of life with these devices is comparable to allograft transplant, they are associated with severe adverse events, including cerebrovascular accidents. Recent advances in continuous-flow technology aim to mitigate the risk of stroke by including design features that minimize flow stasis, turbulence and endothelial dysfunction, as well as promote near-normal pulse pressures. The proposed study is a multicenter, prospective, randomized clinical trial that aims to compare the stroke-free survival and associated incidence and risk of cerebrovascular accidents between three continuous-flow left ventricular assist devices in patients with refractory, end-stage heart failure planning to undergo bridge-to-transplant or destination therapy. Patients will be randomized to receive one of three devices (HeartMate II, Thoratec Corporation, Pleasanton, CA; HeartWare HVAD, HeartWare International Inc., Framingham, MA; HeartMate III, Thoratec Corporation, Pleasanton, CA). Patients will be monitored for stroke-free survival and incidence of cerebrovascular accident for 24 months post-implantation. Investigators will compare stroke-free survival with Kaplan-Meier survival curves and log-rank testing; in addition, investigators will examine each device’s level of risk for causing a cerebrovascular accident with chi square and odds ratio analysis. The data from this study will be used to guide treatment paradigms, device assignment and future development of technologies that mitigate stroke risk in this high-risk population.