Development Of Total Artificial Heart Research Articles

Future technologies in total artificial heart development: can a robot become as good as a donor heart?

Future technologies in total artificial heart development: can a robot become as good as a donor heart?

The ongoing quest for the first total artificial heart as destination therapy.

Many patients with end-stage heart disease die because of the scarcity of donor hearts. A total artificial heart (TAH), an implantable machine that replaces the heart, has so far been successfully used in over 1,700 patients as a temporary life-saving technology for bridging to heart transplantation. However, after more than six decades of research on TAHs, a TAH that is suitable for destination therapy is not yet available. High complication rates, bulky devices, poor durability, poor biocompatibility and low patient quality of life are some of the major drawbacks of current TAH devices that must be addressed before TAHs can be used as a destination therapy. Quickly emerging innovations in battery technology, wireless energy transmission, biocompatible materials and soft robotics are providing a promising opportunity for TAH development and might help to solve the drawbacks of current TAHs. In this Review, we describe the milestones in the history of TAH research and reflect on lessons learned during TAH development. We summarize the differences in the working mechanisms of these devices, discuss the next generation of TAHs and highlight emerging technologies that will promote TAH development in the coming decade. Finally, we present current challenges and future perspectives for the field.

The Biocompatibility Challenges in the Total Artificial Heart Evolution.

There are limited therapeutic options for final treatment of end-stage heart failure. Among them, implantation of a total artificial heart (TAH) is an acceptable strategy when suitable donors are not available. TAH development began in the 1930s, followed by a dramatic evolution of the actuation mechanisms operating the mechanical pumps. Nevertheless, the performance of TAHs has not yet been optimized, mainly because of the low biocompatibility of the blood-contacting surfaces. Low hemocompatibility, calcification, and sensitivity to infections seriously affect the success of TAHs. These unsolved issues have led to the withdrawal of many prototypes during preclinical phases of testing. This review offers a comprehensive analysis of the pathophysiological events that may occur in the materials that compose TAHs developed to date. In addition, this review illustrates bioengineering strategies to prevent these events and describes the most significant steps toward the achievement of a fully biocompatible TAH.

Designing a Total Artificial Heart Based on Rotary Blood Pumps

This article describes the design of a nonpulsating total artificial heart (TAH), presents the basic preconditions for the creation of a nonpulsating artificial heart, describes the design solutions in the design of the TAH, and provides the basic characteristics and stages of TAH development projects in the world.

Double-wire sternal closure technique in bovine animal models for total artificial heart implant.

In vivo preclinical testing of mechanical circulatory devices requires large animal models that provide reliable physiological and hemodynamic conditions by which to test the device and investigate design and development strategies. Large bovine species are commonly used for mechanical circulatory support device research. The animals used for chronic in vivo support require high-quality care and excellent surgical techniques as well as advanced methods of postoperative care. These techniques are constantly being updated and new methods are emerging.We report results of our double steel-wire closure technique in large bovine models used for Cleveland Clinic's continuous-flow total artificial heart development program. This is the first report of double-wire sternal fixation used in large bovine models.

A mock circulatory loop for designing and evaluating total artificial hearts.

A mock circulatory loop was constructed to facilitate total artificial heart development. The loop includes many novel features such as a pressure-regulated tank to simulate exercise conditions, controllable systemic and pulmonary vascular resistance to create left-right flow imbalances as seen in postural change and breathing, and a left atrial suction valve. Dual HeartMate II pumps and the BiVACOR® rotary total artificial heart were used to generate pressure and flow data characterizing the flow loop.

Heart Failure and Mechanical Circulatory Assist Devices

During the last 20 years, the management of heart failure has significantly improved by means of new pharmacotherapies, more timely invasive treatments and device assisted therapies. Indeed, advances in mechanical support, namely with the development of more efficient left ventricular assist devices (LVAD), and the total artificial heart have reduced mortality and morbidity in patients with end-stage heart failure awaiting for transplantation. However, the transplant cannot be the only solution, due to an insufficient number of available donors, but also because of the high number of patients who are not candidates for severe comorbidities or advanced age. New perspectives are emerging in which the VAD is no longer conceived only as a “Bridge to Transplant”, but is now seen as a destination therapy. In this review, the main VAD classification, current basic indications, functioning modalities, main limitations of surgical VAD and the total artificial heart development are described.

Anatomic Fitting of Total Artificial Hearts for In Vivo Evaluation

Successful anatomic fitting of a total artificial heart (TAH) is vital to achieve optimal pump hemodynamics after device implantation. Although many anatomic fitting studies have been completed in humans prior to clinical trials, few reports exist that detail the experience in animals for in vivo device evaluation. Optimal hemodynamics are crucial throughout the in vivo phase to direct design iterations and ultimately validate device performance prior to pivotal human trials. In vivo evaluation in a sheep model allows a realistically sized representation of a smaller patient, for which smaller third-generation TAHs have the potential to treat. Our study aimed to assess the anatomic fit of a single device rotary TAH in sheep prior to animal trials and to use the data to develop a three-dimensional, computer-aided design (CAD)-operated anatomic fitting tool for future TAH development. Following excision of the native ventricles above the atrio-ventricular groove, a prototype TAH was inserted within the chest cavity of six sheep (28-40 kg). Adjustable rods representing inlet and outlet conduits were oriented toward the center of each atrial chamber and the great vessels, with conduit lengths and angles recorded for future analysis. A three-dimensional, CAD-operated anatomic fitting tool was then developed, based on the results of this study, and used to determine the inflow and outflow conduit orientation of the TAH. The mean diameters of the sheep left atrium, right atrium, aorta, and pulmonary artery were 39, 33, 12, and 11 mm, respectively. The center-to-center distance and outer-edge-to-outer-edge distance between the atria, found to be 39 ± 9 mm and 72 ± 17 mm in this study, were identified as the most critical geometries for successful TAH connection. This geometric constraint restricts the maximum separation allowable between left and right inlet ports of a TAH to ensure successful alignment within the available atrial circumference.

Past and present of cardiocirculatory assist devices: a comprehensive critical review

During the last 20 years, the management of heart failure has significantly improved by means of new pharmacotherapies, more timely invasive treatments and device assisted therapies. Indeed, advances in mechanical support, namely with the development of more efficient left ventricular assist devices (LVADs), and the total artificial heart have reduced mortality and morbidity in patients awaiting transplantation, so much so, that LVADs are now approved of as a strategy for destination therapy. In this review, the authors describe in detail the current basic indications, functioning modalities, main limitations of surgical LAVDs, total artificial heart development, and percutaneous assist devices, trying to clarify this complex, but fascinating topic.

How the Dream of an “Artificial Heart” Was Realized in Japan

How the Dream of an “Artificial Heart” Was Realized in Japan

Development of Total Artificial Heart with Economical and Durability Advantages

To develop a total artificial heart (TAH) pump system, we created a design paying particular attention to durability and cost. We adopted a pneumatically driven sac type artificial heart, where the configuration of the sac was decided according to the methodology of flow visualization. Its configuration is almost round to achieve as little stagnation as possible and a low turbulent flow. The main body of the sac was made using polyvinyl chloride (PVC) paste. The paste was poured into an external mold, and heated in a hot air drying oven. Coating was performed using polyurethane. The basic performance of this pump system was tested using a model circulation circuit, and a fitting study through acute animal experiment, using a healthy adult goat, was carried out. As for the TAH produced experimentally, a pump output exceeding 5.0 l/min in the model circulation circuit was provided. Implantation in the internal pleural cavity of a healthy adult goat, 55 kg in weight, proved possible and quite easy in comparison. It is thought that a more refined design in the connector part is desirable. Furthermore, a chronic experiment with the TAH will be carried out, and examination will need to be repeated in the future.

Past, present, and future of total artificial heart development at research institute of replacement medicine, Hiroshima University School of Medicine.

The history and recent progress in total artificial heart (TAH) development were reviewed and divided into three stages. The first stage was between 1966 and 1972, when a trial developing an artificial heart (AH) driver was begun using poppet valves. Fluid amplifiers and air operated valves were then employed as a controller. The second stage was between 1973 and 1983. Several models of pneumatic AH were manufactured and implanted into animals, and it was confirmed that animals could survive with their circulation supported by these mechanical hearts. The third stage was from 1984 to the present, and now a trial to construct a totally implantable type of AH is under way. On the basis of the experience of developing TAHs, the following points are discussed as future problems to be solved: first, the production of small yet powerful actuators; second, the establishment of safe and reliable controls and an energy supply method; third, the development of a durable blood chamber containing valves; and fourth, the acquisition of large research funds for TAH from governments and other granting agencies.

Progress in Cleveland Clinic–Nimbus Total Artificial Heart Development

A totally implantable, Cleveland Clinic-Nimbus total artificial heart (TAH) uses electrohydraulic energy conversion and an automatic left master-alternate mode control scheme, with a filling sensitivity of 1.0 l/min/mmHg and a maximum output of 9.5 l/min. The TAHs were tested in 12 calves for 1-120 days with normal major organ and blood cell function. Post-operative suppression of platelet aggregation recovered by the second post-operative week. The gelatin-coated pump surface generally was clean without any anticoagulants and free from infection. Embolism, which occurred in two cases, was caused by complications attributable to fungal infection in a Dacron graft and by thrombus formed around a jugular vein catheter. A system with a hybridized microcircuit controller in the interventricular space has been tested successfully in the three most recent cases, with a peak device surface temperature elevation of 6.5 degrees C. Heat effects were confined to the tissues immediately adjacent to the hottest spots. The carbon fiber-reinforced epoxy housing and 60 ml butyl rubber compliance chamber showed good tissue compatibility with a thin, fibrous tissue capsule. The transcutaneous energy transmission system and the internal battery functioned well as designed in the most recent animal implant.

Permanent Implantation of the Jarvik-7 Total Artificial Heart: A Clinical Perspective

In this issue ofTHE JOURNAL, DeVries 1 reports the clinical courses of four patients in whom Jarvik-7 total artificial heart (TAH) prostheses were implanted as permanent cardiac substitutes. All four patients subsequently suffered serious complications; despite these, three patients achieved survival with the TAH for intervals of 112, 488, and 620 days. The Jarvik-7 prosthesis is a direct descendant of the early series of pneumatically driven TAH prostheses developed by Willem Kolff, MD, and colleagues working first at The Cleveland Clinic and later at the University of Utah. 2 In February 1963, Michael E. DeBakey, MD, proposed that the federal government support an organized program to develop a TAH. 3 Established at the National Institutes of Health in 1964, the Artificial Heart Program had as its goals the development of a broad spectrum of devices for short-term circulatory and longterm ventricular assistance as well as the development of TAH

Experimental results for chronic left ventricular assist and total artificial heart development.

After more than 20 years of research on the artificial heart, it is now accepted that the pneumatically actuated total artificial heart can maintain near-normal physiology in experimental animals for several months. Such systems are clinically acceptable for short-term application (a few months) in patients waiting for a suitable heart transplant. However, realistically, a cardiac prosthesis that has the capability of being totally implantable for over 2 years must be available. Based on this premise, our group initiated the development of a mechanically actuated total artificial heart, capable of coupling with either a thermal or electrical actuation system. Since 1977, under the National Institutes of Health chronic left ventricular assist program, we have used two different pusher-plate pumps and electrical systems. Taking advantage of technology generated in these programs, we began developing a prosthesis to replace the total cardiac function. This paper is a summary of both the chronic left ventricular assist and total artificial heart development progress in this laboratory.