Neurocognitive function in destination therapy patients receiving continuous-flow vs pulsatile-flow left ventricular assist device support.

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.

Ethical considerations for ventricular assist device support: a 10-point model.

The potential for long-term support on a ventricular assist device (VAD) in the bridge-to-transplant (BTT) and destination therapy (DT) settings has created unprecedented ethical challenges for patients and caregivers. Concerns include the patient's adaptation to life on a device and the ethical, clinical, and practical issues associated with living on mechanical support. On the basis of our experience treating 175 consecutive VAD patients, we have developed a model to address the ethical and psychosocial needs of patients undergoing VAD implantation. Patient preparation for VAD implantation encompasses three phases: 1) initial information regarding the physical events involved in implantation, risks and benefits of current device technology, and the use of VAD as a rescue device; 2) preimplant preparation including completion of advance directives specific to BTT/DT, competency determination, and identifying a patient spokesperson, multidisciplinary consultants, and cultural preferences regarding device withdrawal; and 3) VAD-specific end-of-life issues including plans for device replacement and palliative care with hospice or device withdrawal. This three-phase 10-point model addresses the ethical and psychosocial issues that should be discussed with patients undergoing VAD support.

Neurocognitive assessments in advanced heart failure patients receiving continuous-flow left ventricular assist devices.

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.

Death of a living liver donor from illicit drugs.

In children with acute hepatic failure, it has been suggested to offer living donor transplantation to all parents when a deceased donor organ can not be provided. Ethically, living related donation is coercive by its very nature, especially in emergencies. We report a 36-year-old woman who died from a drug overdose 57 days after living donor liver resection. The recipient was her 3-year-old son, who experienced acute hepatic failure as a result of acetaminophen intoxication. A deceased donor organ had not become available within 2 days after listing. Was the death of this living donor preventable or unpreventable? Certainly if the mother had decided not to take drugs, she would not have died from an overdose. One could argue that this was her personal choice, and beyond our influence. On the other hand, if we had not performed the surgery, the recipient might have died without receiving a liver transplant in time.

Cognitive dysfunction in advanced heart failure and prospective cardiac assist device patients.

BACKGROUND: Extended periods of hypoperfusion in an advanced heart failure (HF) places patients at high risk for neurobehavioral compromise, which has not been studied systematically. It is also not clear how intravenous inotropic therapy and mechanical cardiac assist devices (MCAD) affect cognitive function. METHODS: This prospective cross-sectional cognitive preliminary study evaluated 252 potential heart transplant candidates assessing functions in memory, motor, and processing speed. Patients were divided into three HF groups based on severity of disease: group 1 outpatients (n = 113), group 2 in-patients requiring inotropic infusion (n = 83), and group 3 inpatients likely requiring MCAD support (n = 56). Aggregate z-scores for memory, motor, and processing speed and independent samples t tests assessed intergroup differences on 13 cognitive measures. RESULTS: A broad pattern of cognitive impairment was observed within the advanced HF group; fewer deficits were found in group 1 outpatients and more severe deficits in group 3 MCAD subjects. A difference in motor functions was observed as the earliest abnormality, with group 3 showing significant changes compared with group 1. The most dramatic changes were seen in domain mental processing speed along with specific verbal and visual memory functions, which were slower in group 3 compared with groups 1 and 2. CONCLUSIONS: Cognitive deficits are common in advanced HF and worsen with increasing severity of HF. Appropriately designed and randomized studies will be needed to demonstrate if earlier MCAD implantation is warranted to arrest cognitive dysfunction and better postimplantation adaptation.