A computational model has been developed to study the effects of left ventricular assist devices (LVADs) on the cardiovascular system during a ventricular collapse. The model consists of a toroidal pulsatile blood pump and a closed loop circulatory system. Together, they predict the pump's motor current traces that reflect ventricular suck-down and provide insights into torque magnitudes that the pump experiences. In addition, the model investigates likeliness of a suction event and predicts reasonable outcomes for a few test cases. Ventricular collapse was modeled with the help of a mock circulatory loop consisting of a artificial left ventricle and centrifugal continuous flow pump. This study also investigates different suction detection schemes and proposes the most suitable suction detection algorithm for the TORVAD pump, toroidal left ventricular assist device. Model predictions were further compared against the data sampled during in vivo animal trials with the TORVAD system. The two sets of results are in good accordance. / text

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.

Purpose: Patients living with advanced heart failure experience dyspnea, fatigue, poor quality of life, depression and cognitive impairment which may threaten their ability to provide informed consent to undergo heart transplant (HTx) or mechanical support (LVAD). Using qualitative and quantitative methods, we asked how patients with advanced heart failure make decisions regarding HTx and LVAD. The variables chosen to reflect the elements of consent included quality of life and symptom severity (voluntariness), depression and cognitive impairment (capacity) and treatment preferences (decision-making). Methods: 76 patients enrolled in the quantitative arm completed the Minnesota Living with Heart Failure Questionnaire; Visual Analog scales for dyspnea, fatigue and overall health; Beck Depression Inventory; Montreal Cognitive Assessment; Standard Gamble and Time Tradeoff. Qualitative methods were used to discover concepts, relationships and decision-making processes described by 17 of the 76 patients considering HTx and LVAD. Results: Patients reported poor quality of life and high symptom severity scores which compelled them to consider surgery as a way to relieve unpleasant symptoms and improve quality of life. Although 30% of patients had evidence of depression and/or cognitive impairment, no patient was deemed incapable of decision-making. Patients were willing to take considerable risk (35%) and trade considerable time (4months) to improve their health. While heart failure-related concepts were important to the decision, entrustment emerged as the meaningful process for decision-making. Conclusions: Patients who participated in this study were capable of decision-making and understood the risks associated with the surgery. Voluntariness was diminished by disease but not absent, and decisions were free of coercion. These results suggest the entrustment model of decision-making is the dominant process for patients considering high-risk surgical procedures and meets criteria for informed consent. Understanding the process of decision-making will help clinicians support and enable treatment decisions made by patients living with advanced heart failure.

Purpose: Patients living with advanced heart failure experience dyspnea, fatigue, poor quality of life, depression and cognitive impairment which may threaten their ability to provide informed consent to undergo heart transplant (HTx) or mechanical support (LVAD). Using qualitative and quantitative methods, we asked how patients with advanced heart failure make decisions regarding HTx and LVAD. The variables chosen to reflect the elements of consent included quality of life and symptom severity (voluntariness), depression and cognitive impairment (capacity) and treatment preferences (decision-making). Methods: 76 patients enrolled in the quantitative arm completed the Minnesota Living with Heart Failure Questionnaire; Visual Analog scales for dyspnea, fatigue and overall health; Beck Depression Inventory; Montreal Cognitive Assessment; Standard Gamble and Time Tradeoff. Qualitative methods were used to discover concepts, relationships and decision-making processes described by 17 of the 76 patients considering HTx and LVAD. Results: Patients reported poor quality of life and high symptom severity scores which compelled them to consider surgery as a way to relieve unpleasant symptoms and improve quality of life. Although 30% of patients had evidence of depression and/or cognitive impairment, no patient was deemed incapable of decision-making. Patients were willing to take considerable risk (35%) and trade considerable time (4months) to improve their health. While heart failure-related concepts were important to the decision, entrustment emerged as the meaningful process for decision-making. Conclusions: Patients who participated in this study were capable of decision-making and understood the risks associated with the surgery. Voluntariness was diminished by disease but not absent, and decisions were free of coercion. These results suggest the entrustment model of decision-making is the dominant process for patients considering high-risk surgical procedures and meets criteria for informed consent. Understanding the process of decision-making will help clinicians support and enable treatment decisions made by patients living with advanced heart failure.

This thesis presents a finite element methodology for simulating fluid–solid interactions in the left ventricle (LV) under LVAD support. The developed model was utilised to study the passive and active characteristics of ventricular function in anatomically accurate LV geometries constructed from normal and patient image data. A non–conforming ALE Navier–Stokes/finite–elasticity fluid–solid coupling system formed the core of the numerical scheme, onto which several novel numerical additions were made. These included a fictitious domain (FD) Lagrange multiplier method to capture the interactions between immersed rigid bodies and encasing elastic solids (required for the LVAD cannula), as well as modifications to the Newton–Raphson/line search algorithm (which provided a 2 to 10 fold reduction in simulation time). Additional developments involved methods for extending the model to ventricular simulations. This required the creation of coupling methods, for both fluid and solid problems, to enable the integration of a lumped parameter representation of the systemic and pulmonary circulatory networks; the implementation and tuning of models of passive and active myocardial behaviour; as well as the testing of appropriate element types for coupling non–conforming fluid– solid finite element models under high interface tractions (finding that curvilinear spatial interpolations of the fluid geometry perform best). The behaviour of the resulting numerical scheme was investigated in a series of canonical test problems and found to be convergent and stable. The FD convergence studies also found that discontinuous pressure elements were better at capturing pressure gradients across FD boundaries. The ventricular simulations focused firstly on studying the passive diastolic behaviour of the LV both with and without LVAD support. Substantially different vortical flow features were observed when LVAD outflow was included. Additionally, a study of LVAD cannula lengths, using a particle tracking algorithm to determine recirculation rates of blood within the LV, found that shorter cannulas improved the recirculation of blood from the LV apex. Incorporating myocardial contraction, the model was extended to simulate the full cardiac cycle, converging on a repeating pressure–volume loop over 2 heart beats. Studies on the normal LV geometry found that LVAD implementation restricts the recirculation of early diastolic inflow, and that fluid–solid coupled models introduce greater heterogeneity of myocardial work than was observed in equivalent solid only models. A patient study was undertaken using a myocardial geometry constructed using image data from an LVAD implant recipient. A series of different LVAD flow regimes were tested. It was found that the opening of the aortic valve had a homogenising effect on the spatial variation of work, indicating that the synchronisation of LVAD outflow with the cardiac cycle is more important if the valve remains shut. Additionally, increasing LVAD outflow during systole and decreasing it during diastole led to improved mixing of blood in the ventricular cavity – compared with either the inverse, or holding outflow constant. Validation of these findings has the potential to impact the treatment protocols of LVAD patients.