ABSTRACT
BACKGROUND: The HeartMate II (Thoratec Corp, Pleasanton, CA) continuous-flow left ventricular assist device (LVAD) improved survival in destination therapy (DT) patients during a randomized trial compared with pulsatile-flow LVADs. This study documented changes in cognitive performance in DT patients from that trial to determine if there were differences between continuous-flow and pulsatile-flow support. METHODS: Data were collected in a sub-study from 96 HeartMate II continuous-flow and 30 HeartMate XVE pulsatile-flow LVAD patients from 12 of the 35 trial sites that followed the same serial neurocognitive (NC) testing protocol at 1, 3, 6, 12, and 24 months after LVAD implantation. Spatial perception, memory, language, executive functions, and processing speed were the domains assessed with 10 standard cognitive measures. Differences over time and between LVAD type were evaluated with linear mixed-effects modeling. RESULTS: From 1 to 24 months after LVAD implantation, changes in NC functions were stable or showed improvement in all domains, and there were no differences between the continuous-flow and pulsatile-flow groups. Data at 24 months were only available from patients with the continuous-flow LVAD due to the limited durability of the HeartMate XVE device. There was no decline in any NC domain over the time of LVAD support. Missing data not collected from patients who died could have resulted in a bias toward inflated study results. CONCLUSIONS: The NC performance of advanced heart failure patients supported with continuous-flow and pulsatile-flow LVADs shows stabilization or improvement during support for up to 24 months.
Subject(s)
Cognition/physiology , Heart Failure/therapy , Heart Transplantation , Heart-Assist Devices , Adult , Aged , Female , Follow-Up Studies , Heart Failure/physiopathology , Heart Failure/psychology , Humans , Male , Memory/physiology , Middle Aged , Prosthesis Design , Treatment OutcomeABSTRACT
BACKGROUND: Neurocognitive (NC) changes in heart failure patients receiving left ventricular assist devices (LVADs) are not well understood. The purpose of this study was to document changes in the cognitive performance of patients with the continuous-flow HeartMate II LVAD as a bridge to transplant (BTT). METHODS: A NC protocol was used to evaluate patient performance at 1, 3 and 6 months after LVAD implantation at 11 centers. A total of 239 test sessions were completed in 93 patients including paired evaluations in 51 to 57 patients from 1 to 3 months, and in 20 to 28 patients with results from 1, 3 and 6 months. Five NC domains were assessed, including visual spatial perception, auditory and visual memory, executive functions, language and processing speed. RESULTS: There were statistically significant (p < 0.05), but limited improvements between 1, 3 and 6 months in NC domain performances as seen in visual memory, executive functions, visual spatial perception and processing speed. There were no significant declines in any neurocognitive test in any domain over these time periods. CONCLUSIONS: The cognitive performance of advanced heart failure patients remained stable or showed slight improvements from Month 1 to Month 6 of continuous-blood-flow support with the HeartMate II LVAD.
