The purpose of this study was to evaluate graded exercise responses to treadmill exercise in patients with a total artificial heat (SynCardia, Tucson, AZ). Additionally, this study sought to compare the exercise response in total artificial heart (TAH) patients to both advanced heart failure (HF) patients on medical management only and HeartMate II (Thoratec Corp., Pleasanton, CA) left‐ventricular assist device (HMII) patients. For patients with biventricular heart failure the TAH is a viable option to bridge patients until transplant becomes available. Its demonstrated improvement in mortality and increasing usage necessitates a shift in focus to quality of life in the TAH patient including functional ability. The evaluation of cardiorespiratory responses to graded exercise provides an objective measure of functional ability. There is very limited information in the literature on the exercise response of the mechanical circulatory support (MCS) device patient, particularly the TAH patient. A review was performed on MCS patients who underwent symptom‐limited cardiopulmonary exercise testing (CPET) following device implant of either TAH or HMII. ANOVA was performed to compare differences between the two device groups and HF patients listed for heart transplant. Fourteen TAH patients underwent CPET (9 male, 5 female) with peak oxygen consumption (VȩO2) of 0.926 + .168 L∙min, 36 + 8% % predicted, 11.0 + 2.3 ml.kg.min or 3.1 + 0.7 METs. Ventilatory anaerobic threshold (VAT) was 0.706 + .181 L∙min. Peak (VȩO2, % pred. (VȩO2 and VAT were significantly lower in the TAH compared with HMII and advanced HF (p = 0.0012, p = 0.0106, p = 0.0009, respectively). Peak RER was significantly higher (p = <.0001) and OUES was significantly lower (p = 0.0004) in the TAH. Exercise capacity is significantly reduced in the TAH patient below that observed in HMII LVAD and advanced HF patients. This provides a baseline for expected functional status and has implications on the ADL tolerance of these individuals. The next step is to develop strategies to ameliorate this continued exercise intolerance. The documents herein contain a review of literature including a background in heart failure and the use of the exercise response in the heart failure patient. An overview is also presented on the use of MCS describing physiology, device function, and exercise physiology of the MCS device patient. A manuscript has also been included detailing a cross‐sectional review of the effects of graded exercise in the TAH patient and comparing it to the HMII and advanced HF patient.

Bei der Entwicklung von Herzunterstützungssystemen oder Systemen für den totalen Herzersatz muss untersucht werden, ob ein definierter Blutfluss gewährleistet werden kann und entsprechende Druckdifferenzen erzeugt werden können. Zudem ist eine möglichst geringe Blutschädigung von großer Bedeutung.  Zur Untersuchung der Förderleistung wird der erzeugte Volumenstrom bei verschiedenen Leistungsaufnahmen (Stromstärken) ermittelt. Es zeigt sich ein linearer Zusammenhang zwischen Leistungsaufnahme (A) und erzeugtem Fluss (l/min), da der erzeugte Druckgradient der Kraft des Kolbens proportional ist. Im Weiteren werden Druck- und Flussbeziehungen bei maximaler Leistungsaufnahme gemessen und dargestellt. Hier zeigt sich, dass bis zu einer Nachlast von 120 mmHg die maximale Flussrate von 11 l/min erzielt wird.  In weiteren Versuchsreihen wird das Ausmaß der Hämolyse bestimmt, indem die lineare Blutpumpe mit einem klinisch etablierten System (Medos-HIA-Ventrikel) verglichen wird. Dafür wird der normierte Hämolyse Index (NIH) bestimmt. Die vergleichende Untersuchung im Modellkreislauf ergibt, dass für die lineare Blutpumpe der Index 0,078 g/100l zwar höher liegt, als bei dem klinisch etablierten Medos-Ventrikel 0,0037 g/100l, die Erythrozyten-, Thrombozyten- und Leukozytenzahl sowie der Hkt bleiben aber unverändert über sechs Stunden. Die hier vorgestellte lineare Blutpumpe besitzt neben ausreichender Leistungsfähigkeit und neuartigen Regulationsmöglichkeiten eine dem Entwicklungsstand nach geringe blutschädigende Wirkung. Die lineare Blutpumpe stellt damit einen geeigneten neuen Lösungsansatz zur Konstruktion eines pulsatilen Geräts zu Herzunterstützung als auch totalem Herzersatz dar.

The long-term performance of TAH pumps needs to be demonstrated. Reliability tests are performed to measure its ability to operate for months, or years, without failure. Real Heart is currently constructing test rigs for this purpose. Software for documenting test rig conditions is also required. Thus, the objective of this study is to assist in developing reliability test rig software.  The software is written in LabVIEW and is hosted on a CompactRIO controller. Requirements include sampling of sensor data, logging, and alarms. Additionally, a PC dashboard is constructed for monitoring real-time data, reviewing logs, as well as controls for acquisition. Results of this study present a foundation for the test rig software. It features a modular architecture which allows for future scalability. The process of development involves research of hardware/software, establishing a reference design and to build and validate each module through test simulations. Data acquisition is set up with the NI-DAQmx API. It features automatic configuration for thermocouple, as well as custom signal scaling of the pressure and flow transducers. However, grouping of data and synchronization for logging and alarms was a challenge. The producer/consumer design pattern is implemented for grouping data as well as synchronization for logging and alarms. / Det artificiella hjärtats långsiktiga prestanda måste demonstreras. Tillförlitlighetstester utförs för att mäta pumparnas förmåga att fungera i månader eller år utan att gå sönder. Real Heart bygger för närvarande testriggar för detta ändamål. Programvara för att dokumentera testriggens förhållanden behövs också. Därför är syftet med denna studie att hjälpa företaget med att utveckla programvara för tillförlitlighetstestriggar.  Programvaran är skriven i LabVIEW och används på en CompactRIO-kontroller. Den kommer inkludera provtagning av sensordata, loggning och alarm. Dessutom är en PC-instrumentpanel konstruerad för övervakning av realtidsdata, granskning av loggar samt kontroll av datainsamling. Resultaten av denna studie utgör en grund för testriggens programvara. Den har en modulär arkitektur som möjliggör framtida uppskalning. Utvecklingsprocessen involverar studier av hårdvara/programvara, upprättande av en referensdesign, samt att bygga och validera varje modul genom testsimuleringar. Datainsamling genomförs med NI-DAQmx API. Den har automatisk konfiguration för temperatur, samt anpassad signalskalning av tryck- och flödesgivare. Designmönstret producent/konsument implementerades för gruppering av data, samt synkronisering för loggning och alarm.

No description available.

Heart failure (HF) affects an estimated 5.8 million Americans, accounting for near 250,000 deaths each year. With shortages in available donor hearts, mechanical circulatory support (MCS) has emerged as a life-saving treatment for advanced stage HF. With growth in MCS use, a clinical and developmental need has emerged for a standard characterization and evaluation platform that may be utilized for inter-device comparison and system training. The goal of this research was to harness SynCardia's total artificial heart (TAH) to meet this need. We first sought to characterize the TAH in modern physiological terms - i.e. hemodynamics and pressure-volume loops. We then developed a model of HF using the TAH and mock circulatory system operating in a reduced output mode. We demonstrated that MCS devices could be incorporated and evaluated within the HF model. Finally, we characterized the operational envelope of SynCardia's Freedom (portable), Driver operating against varying loading conditions. Our results describe the hemodynamic envelope of the TAH. Uniquely, the TAH was found not to operate with time-varying elastance, to be insensitive to variations in afterload up to at least 135 mmHg mean aortic pressure, and exhibit Starling-like behavior. After transitioning the setup to mimic heart failure conditions, left atrial pressure and left ventricular pressure were noted to be elevated, aortic flow was reduced, sensitivity to afterload was increased, and Starling-like behavior was blunted, consistent with human heart failure. The system was then configured to allow ready addition of ventricular assist devices, which upon placement in the flow circuit resulted in restoration of hemodynamics to normal. Lastly, we demonstrated that the Freedom Driver is capable of overcoming systolic pressures of 200 mmHg as an upper driving limit. Understanding the physiology and hemodynamics of MCS devices is vital for proper use, future device development, and operator training. Characterization of the TAH affords insight into the functional parameters that govern artificial heart behavior providing perspective on differences compared to the human heart. The use of the system as a heart failure model has the potential to serve as a valuable research and teaching tool to foster safe MCS device use.

Millions of people suffer from heart failure worldwide. The need for heart donations started the development of mechanical circulatory support systems. A suction phenomenon can occur in the artificial heart when not enough blood is available. Due to occlusion, suction in the artificial heart can cause the arteries to collapse and have fatal consequences. This thesis is in collaboration with Scandinavian Real Heart AB and follows the implementation of a preemptive atrial suction detection algorithm for the total artificial heart (TAH) developed by Realheart. The main limitation is the number of sensors available to collect data from, restricted to a pressure and current sensor. The data used in the thesis is collected on a mock loop that simulates the pressures in the human body. The implementation follows an iterative process where different Artificial Intelligence algorithms are tested and evaluated. The final algorithm uses a recurrent neural network (RNN) for classification and is evaluated based on the accuracy and the number of seconds before suction occurs. The results show that the RNN can preemptively classify the data one second before it occurs. The algorithm assumes suction to happen one second before it occurs, preemptively detecting suction. The results from this thesis enable a continuation that can improve the development of TAHs. Future work includes an addition of features for a more accurate and robust algorithm, a more diverse dataset, an improved labelling process and the addition of a time axis to the RNN to improve the time before suction is detected.

Over eight decades of research into total artificial hearts (TAHs) has significantly contributed  to saving end-stage heart failure patients. However, at the current stage of development TAHs have several limitations, one of them being their bulkiness. Hence this thesis, with the goal to evaluate the right pump of the TAH developed by Scandinavian Real Heart and propose a compact right drive system without consuming significantly more power than the initial system. In order to do this, the requirements for the right drive systems are evaluated and defined. These requirements are then used to develop a methodology, including a MatLab simulation, for examining and selecting motors for the drive unit of the TAH. Subsequently, the methodology and the simulation are used to identify and assess over 200 motors, as well as select 3 motors for real-world experimental analysis. The suggested motors and the initial motor are then tested in a mock circulatory loop to investigate the performance characteristics and power consumption of the motors. This is done to select the final motor for the right drive unit, as well as verify and validate the created simulation. Based on careful analysis of the mathematical models used in the simulation and presented experimental data, the simulation was accepted to be verified. However, the support for validation of the simulation was lacking, as conflicting outcome for some cases were observed between the simulation and experimental data. Furthermore, given the empirical evidence, a brushless dc motor for the right drive unit and its implementation was proposed. The proposed motor has 11% reduction in size, 20% reduction in power consumption and 34% reduction in weight compared to the initial motor. Therefore, a drive unit with the suggested motor can have a significant impact on the right pump, and potentially even the left pump. Furthermore, the utilisation of the developed simulation can ultimately result in efficient and cost-effective motor selection and provide valuable contribution to the field of drive system development for TAHs. / Över åtta decennier av forskning om totala artificiella hjärtan (TAH) har omfattande bidragit till att rädda patienters liv med kronisk hjärtsvikt. Dessvärre har TAH flera begränsningar i det nuvarande stadiet i utveckling där storleken är ett problem. Därav denna avhandling, med målet att utvärdera den högra pumpen av en TAH utvecklad av Scandinavian Real Heart, för att föreslå ett mer kompakt höger drivsystem utan att det ska förbruka väsentlig mängd mer energi än det ursprungliga systemet. För att åstadkomma detta, har de fysiologiska krav för den högra pumpen analyserats och utifrån den utförda analysen nya krav för drivsystemet har formulerats. Dessa krav har sedan lagt grunden till utveckling av en metodik, inklusive en MatLab-simulering, för att undersöka och välja motorer för drivsystemet av en TAH. Metodiken i samband med simuleringen har använts för att identifiera och bedöma över 200 motorer. Av dessa motorer har tre motorer valts för experimentell utvärdering. I den experimentella utvärderingen, prestandaegenskaper och effektförbrukning av samtliga valda motorer och den ursprungliga motorn har utvärderats i ett konstgjort cirkulationssystem. Syftet med den experimentella utvärderingen är att komma fram till en slutmotor, samt verifiera och validera den utvecklade simuleringen. Baserad på noggrann analys av de använda matematiska modeller i simuleringen och det presenterade experimentella data, ansågs simuleringen vara verifierad. Däremot saknades stöd för validering av simuleringen, på grund av en del motsägande utfall mellan simulering och experimentell data. Därutöver, utifrån den empiriska evidensen föreslogs en borstlös likströmsmotor och dess implementering för det högra drivsystemet. Den föreslagna motorn är 11% mindre i storlek, har 20% lägre effektförbrukning och väger 34% mindre än den ursprungliga motorn. Därför kan en drivenhet med den föreslagna motorn ha en betydande inverkan på den högra pumpen, och potentiellt även den vänstra. Dessutom kan den utvecklade simuleringen användas för att göra urval av motorer för TAH på ett produktivt samt kostnadseffektivt sätt och därmed bidra till framtida utvecklingar av drivenheter för TAH.

Les assistances circulatoires mécaniques de longue durée (ACM) sont une stratégie de plus en plus répandue pour le traitement des patients porteurs d’insuffisance cardiaque avancée. Cependant, cette option thérapeutique reste associée à des complications immédiates at au suivi parfois particulièrement graves (telles que la thrombose de pompe, les évènements thromboemboliques et le dysfonctionnement du dispositif). Nous formulons l’hypothèse que l’analyse du positionnement postopératoire du dispositif (et notamment, de sa canule d’admission intraventriculaire) peut fournir des informations utiles à la prédiction des évènements cliniques cités ci-dessus. Nous formulons aussi l’hypothèse qu’il est possible d’optimiser la prise en charge de ces patients (choix du dispositif, choix du site ventriculaire et des modalités d’implantation) par le moyen d’une planification préopératoire assistée par ordinateur. Nous avons donc mis en place deux axes de recherche. Dans le premier, nous proposons un système original d’analyse d’orientation intraventriculaire de la canule d’admission (par rapport à la valve mitrale native) ; celui-ci démontre une association significative entre orientation de la canule en direction du septum interventriculaire et apparition clinique des complications. Ce moyen supplémentaire de prédiction spécifique-patient sera validé sur des cohortes plus large et testé dans le cadre d’une étude prospective. Dans le deuxième axe, nous proposons une solution d’implantation virtuelle spécifique patient. Elle est basée sur une segmentation semi-automatique des structures cardiaques, une visualisation augmentée du scanner préopératoire, un positionnement virtuel d’une représentation numérique des différents dispositifs, et une analyse de collision de celui-ci avec la paroi thoracique (ACM mono-ventriculaire et coeur artificiel total) ou le ventricule droit (ACM mono-ventriculaires). Nous ouvrons enfin les perspectives vers une approche d’analyse et prédiction physiologique basée sur la simulation par ordinateur de l’hémodynamique du ventricule gauche assisté. / Long-term circulatory mechanical assist devices are increasingly employed in the management of patients with advanced heart failure. Nonetheless, this therapeutic strategy is still associated with immediate and long-term complications; among these, pump thrombosis, thromboembolic events and pump dysfunction are particularly dreadful. Mechanical factors are involved in their pathogenesis. We hypothesize that the analysis of the post-implantation positioning of the devices (and particularly of the admission cannula for left ventricular assist devices) might provide additional useful information for the prediction of the above events. We also hypothesize that it is possible to optimize the management of these patients (under the perspective of device selection, choice of the left ventricular implantation site and implantation modalities) through computer-assisted preoperative planning. We have therefore established two axes of research. With the first axis, we propose an original system for orientation analysis of the intraventricular admission cannula with respect to the mitral valve (postoperative CT scan). This analysis indicates a significant association between the cannula orientation towards the interventricular septum and the occurrence of early/delayed complications. This novel method will be validated in larger cohorts and tested in a prospective clinical investigation. With the second axis, we propose a virtual implantation solution (environment Cami-TK), based on semi-automatic segmentation of cardiac structures (preoperative CT scan), augmented visualization of the CT scan images, virtual positioning of a 3D mesh representing the devices, and collision analysis with the thoracic structures (left ventricular assist devices and total artificial heart) or the right ventricle (ventricular assist devices only). We finally indicate future investigations concerning the application of computational fluid dynamics to facilitate computer simulation of the hemodynamics within the assisted left ventricle, and refined prediction of adverse events.

BACKGROUND Cardiac surgery patients have some of the highest reported incidence and prevalence of pressure injuries (PI). A growing subset of cardiac surgery include patients with end-stage heart failure who undergo ventricular assist device (VAD) or total artificial heart (TAH) surgery. The risk of PI and their natural history of development in this population are unknown and the specific risk factors for PI development remain unexplored. OBJECTIVES To perform a systematic review of the literature to identify the incidence and risk factors of PI development in patients undergoing VAD-TAH surgery and thereby inform study design and variables in an eight-year retrospective study of all patients undergoing VAD-TAH surgery at a large academic university medical center. METHODS The preferred reporting items for systematic reviews and meta-analyses or PRISMA statement guided this systematic review. Quality of evidence was determined using the Johns Hopkins Nursing Evidence-Based Practice Rating Scale. Two reviewers independently appraised manuscripts matching the eligibility criteria for study inclusion. Four databases including PubMed, CINAHL, Web of Science, Google Scholar, and hand searches of journals based on reference lists from included studies were utilized. Initial results of this primary search revealed zero studies that met inclusion and this search methodology was confirmed by medical librarian consultation. Therefore, a follow up retrospective study was necessary to identify incidence of PI in the VAD-TAH population. However, a secondary search, dropping keywords of VAD-TAH and instead focusing on studies of on-pump cardiac surgery and mixed surgical studies where cardiac surgery patients were included, was conducted to establish variables to guide a retrospective study of all VAD-TAH surgeries between 2010-2018. The retrospective study evaluated the incidence of pressure ulcers by case, patient and incidence density for each of the respective 1000 patient days during the study period. Univariate statistics are reported by four different VAD-TAH devices. Variables significant in bivariate analysis were entered in a stepwise logistic regression model. RESULTS In the systematic review, 312 articles were identified from the databases with eight additional articles from hand searches. Following abstract review, 208 were excluded for not meeting inclusion criteria or study quality metrics. 77 articles were read in full, with 61 excluded, leaving 16 articles for inclusion. 31 risk factors were identified for PI development in on-pump cardiac surgery patients with 11 risk factors which were identified as significant in multivariate analysis for inclusion in the retrospective study.

No description available.