Observation of cavitation in a mechanical heart valve in a total artificial heart

Recently, cavitation on the surface of mechanical heart valves has been studied as a cause of fractures occurring in implanted mechanical heart valves. The cause of cavitation in mechanical heart valves was investigated using the 25 mm Medtronic Hall valve and the 23 mm Omnicarbon valve. Closing of these valves in the mitral position was simulated in an electrohydraulic totally artificial heart. Tests were conducted under physiologic pressures at heart rates from 60 to 100 beats per minute with cardiac outputs from 4.8 to 7.7 L/min. The disk closing motion was measured by a laser displacement sensor. A high-speed video camera was used to observe the cavitation bubbles in the mechanical heart valves. The maximum closing velocity of the Omnicarbon valve was faster than that of the Medtronic Hall valve. In both valves, the closing velocity of the leaflet, used as the cavitation threshold, was approximately 1.3-1.5 m/s. In the case of the Medtronic Hall valve, cavitation bubbles were generated by the squeeze flow and by the effects of the venturi and the water hammer. With the Omnicarbon valve, the cavitation bubbles were generated by the squeeze flow and the water hammer. The mechanism leading to the development of cavitation bubbles depended on the valve closing velocity and the valve stop geometry. Most of the cavitation bubbles were observed around the valve stop and were generated by the squeeze flow.     

Closing behavior of the mechanical heart valve in a total artificial heart

Recently, cavitation on the surface of mechanical heart valves has been studied as a cause of fractures occurring in implanted mechanical heart valves. The cause of cavitation in mechanical heart valve was investigated in both 25-mm Björk–Shiley and 25-mm Medtronic Hall valves. The closing events of these valves in the mitral position were simulated in an electrohydraulic total artificial heart with a stroke volume of 85?ml. The tests were conducted under physiologic pressures at heart rates of 60, 70, 80, and 90 beats/min with cardiac outputs of 4.5, 5.5, 6.4, and 7.5?l/min, respectively. The disk closing behavior was measured by a laser displacement sensor. The closing behaviors were investigated under various atrial and aortic pressures. In both valves, the duration of closing decreased with an increase in the cardiac output. The greater the amount of atrial pressure, the shorter the closing duration of both valves. The maximum closing velocity of the Medtronic Hall monostrut valve ranged from 0.8 to 0.9?m/s, and that of the Björk–Shiley monostrut valve ranged from 0.73 to 0.78?m/s. In both valves, the maximum closing velocities were less than the reported cavitation thresholds. This suggests that there should be no possibility of occurrence of cavitation in an electrohydraulic total artificial heart with mechanical heart valve.     

Immunologic complications of long-term implantation of a total artificial heart

Bacterial infections are a significant complication of long-term total artificial heart implantation. We evaluated the functional capabilities of host defense mechanisms in two patients sustained long-term by a total artificial heart. Although serum complement and polymorphonuclear leukocyte function remained intact, both patients became B and T lymphopenic and there was an initial decrease in the ratio of helper/inducer to suppressor/cytotoxic cells. Histologic examination of their lymphoidal tissue at autopsy further revealed reduced numbers of germinal centers and atrophy of the T lymphocyte-dependent areas. In addition, the reticuloendothelial system was engorged with degenerate erythrocytes. We hypothesize that blockade of the reticuloendothelial system was induced by multiple blood transfusions necessitated by device-associated hemolysis and coagulopathy. This blockade may have led to a progressive loss of content of the antigen-specific lymphoidal elements and, perhaps, to a reduced ability to ingest microbe-antibody complexes.     

Durability testing of a completely implantable electric total artificial heart

In vitro durability testing was conducted on the Penn State/3M electric total artificial heart (ETAH) to determine device durability and to evaluate device failures. A specialized mock circulatory loop was developed for this testing. Customized software continuously acquired data during the test period, and failures were analyzed using FMEA (failure modes and effects analysis) and FMECA (failure modes, effects, and criticality analysis) principles. Redesigns were implemented when appropriate. Reliability growth principles were then applied to calculate the 1 and 2 year reliability. The 1 and 2 year reliability of the Penn State/3M ETAH was shown to be 96.1% and 59.9%, respectively, at 80% confidence.     

Clinical use of the total artificial heart

We report here our first experience with the use of a total artificial heart in a human being. The heart was developed at the University of Utah, and the patient was a 61-year-old man with chronic congestive heart failure due to primary cardiomyopathy, who also had chronic obstructive pulmonary disease. Except for dysfunction of the prosthetic mitral valve, which required replacement of the left-heart prosthesis on the 13th postoperative day, the artificial heart functioned well for the entire postoperative course of 112 days. The mean blood pressure was 84 +/- 8 mm Hg, and cardiac output was generally maintained at 6.7 +/- 0.8 liters per minute for the right heart and 7.5 +/- 0.8 for the left, resulting in postoperative diuresis and relief of congestive failure. The postoperative course was complicated by recurrent pulmonary insufficiency, several episodes of acute renal failure, episodes of fever of unidentified cause (necessitating multiple courses of antibiotics), hemorrhagic complications of anticoagulation, and one generalized seizure of uncertain cause. On the 92nd postoperative day, the patient had diarrhea and vomiting, leading to aspiration pneumonia and sepsis. Death occurred on the 112th day, preceded by progressive renal failure and refractory hypotension, despite maintenance of cardiac output. Autopsy revealed extensive pseudomembranous colitis, acute tubular necrosis, peritoneal and pleural effusion, centrilobular emphysema, and chronic bronchitis with fibrosis and bronchiectasis. The artificial heart system was intact and uninvolved by thrombosis or infectious processes. This experience should encourage further clinical trials with the artificial heart, but we emphasize that the procedure is still highly experimental. Further experience, development, and discussion will be required before more general application of the device can be recommended.     

Patellofemoral arthroplasty conversion to total knee arthroplasty: Retrieval analysis and clinical correlation

Background

Patellofemoral arthroplasty (PFA) can be a successful, bone-sparing treatment for isolated patellofemoral arthritis. However, progression of tibio-femoral arthritis or incorrect indications may predispose patients to early conversion to total knee arthroplasty (TKA). The purpose of this study was to review the clinical cases and perform retrieval analysis of PFA conversions to TKA at our institution.

In-vitro performance of a single-chambered total artificial heart in a Fontan circulation

Journal of Artificial Organs - An in-vitro study was conducted to investigate the general feasibility of using only one pumping chamber of the SynCardia total artificial heart (TAH) as a...     

Driver electronics design and control for a total artificial heart linear motor

For any implantable device size and efficiency are critical properties. Thus, a linear motor for a Total Artificial Heart was optimized with focus on driver electronics and control strategies. Hardware requirements were defined from power supply and motor setup. Four full bridges were chosen for the power electronics. Shunt resistors were set up for current measurement. Unipolar and bipolar switching for power electronics control were compared regarding current ripple and power losses. Here, unipolar switching showed smaller current ripple and required less power to create the necessary motor forces. Based on calculations for minimal power losses Lorentz force was distributed to the actor’s four coils. The distribution was determined as ratio of effective magnetic flux through each coil, which was captured by a force test rig. Static and dynamic measurements under physiological conditions analyzed interaction of control and hardware and all efficiencies were over 89%. In conclusion, the designed electronics, optimized control strategy and applied current distribution create the required motor force and perform optimal under physiological conditions. The developed driver electronics and control offer optimized size and efficiency for any implantable or portable device with multiple independent motor coils.

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Graphical Abstract ?

     

Observation and quantification of cavitation on a mechanical heart valve with an electro-hydraulic total artificial heart

In previous studies, we investigated the cavitation phenomenon in a mechanical heart valve using an electro-hydraulic total artificial heart. With this system, a 50% glycerin solution kept at 37 degrees C was used as the working fluid. We reported that most of the cavitation bubbles were observed near the valve stop and were caused by the squeeze flow. However, in these studies, the effect of the partial pressure of CO(2) on the mechanical heart valve cavitation was neglected. In this study, in order to investigate the effect of the partial pressure of CO(2) on mechanical heart valve cavitation using an electro-hydraulic total artificial heart, we controlled the partial pressure of the CO(2) in vitro. A 25-mm Medtronic Hall valve was installed in the mitral position of an electro-hydraulic total artificial heart. In order to quantify the mechanical heart valve cavitation, we used a high-speed camera. Even though cavitation intensity slightly increased with increases in the PCO(2) at heart rates of 60, 70 and 100 bpm, throughout the experiment, there was no significant difference between the PCO(2) and cavitation intensity.     

The applicability of experimental experience with the total artificial heart to its clinical use.

Long-term experiments with the total artificial heart (TAH) are a source of valuable knowledge for later clinical application. Our observations result from 66 long-term experiments on calves and one goat ranging from 30 to 314 days, which have shown the main possible complications in the early period (one month) and later in the experiment. Problems until the second month of pumping concern the clinical pendant of the TAH as a bridge for transplantation, i.e. surgical problems, blood coagulation disorders, infection etc. Later problems are high venous pressure or arterial hypertension, infection with septic thromboembolization, mineralization of the driving diaphragm, etc., and are more closely comparable to the conditions of permanent clinical use of the TAH. Faultless surgery, device function and the regimen of pumping are essential factors in every long-term experiment, just as in clinical application. Infection is a threat throughout any experiment, as in clinical cases. The TNS-BRNO-VII/clin/80 TAH has been implanted in six patients.     

Informed consent documentation for total artificial heart technology

The supply of human donor hearts continues to fall short of clinical need. Educational efforts to increase organ donation have not been able to significantly narrow the shortfall of human hearts, and bridging devices such as left ventricular assist systems actually cause the United Network for Organ Sharing (UNOS) waiting list to swell. In an effort to address these matters, scientists continue the quest for a total artificial replacement heart for permanent implantation. Although the Jarvik-7 trials proved technically and ethically complex, this has not deterred research on this technology, and human clinical trials are on the horizon. One of the ethical challenges of this technology is obtaining informed consent. This analysis reflects on past trials and offers ethical guidance on preparing informed consent documentation for human clinical trials of total artificial replacement heart technology.     

Cardiac output requirements and maximum dimensions for a neonate total artificial heart.

Two equally important issues need to be addressed during the early stages of the design of an implantable total artificial heart (TAH): proper anatomical fit and cardiac output capacity. As part of a first-time feasibility study to develop a neonate-size TAH, two studies were conducted to establish useful anatomical and physiological standards. The first (Study A) was conducted to determine the maximum dimensions of a neonate-size TAH. Twelve preserved hearts from full-term neonates with the hypoplastic left heart syndrome were examined. A second study (Study B) was designed to determine the acceptable minimum stroke volume compatible with minimum neonate cardiac output requirements. This study was based on a combination of: a) reported cardiac output studies in healthy term neonates, and term neonates with heart failure, b) body weight range, and c) limiting factors of TAH technology, e.g., valvular regurgitation and leveling off of the maximum cardiac output value at a specific heart rate and filling pressure. The proposed neonatal standards for TAH technology are presented.     

Calves chronically implanted with a total artificial heart as a pharmacological model.

Pharmacological therapy for congestive heart failure includes drugs that have both inotropic and vasoactive effects, although it is sometimes difficult to differentiate between the two effects. An animal with an implanted total artificial heart (TAH) allows the investigation of the vascular effect of these drugs in the absence of the effect on the myocardium. An advantage of the TAH model is its sensitivity to changes in right and left ventricular preload and afterload. Four instrumented TAH calves were given vasoactive drugs and the response was compared to control. Epinephrine, dopamine, isoproterenol, and nitroprusside were selected because of the predictability of their responses. Epinephrine caused a significant increase in systemic vascular resistance (SVR), and dopamine caused a significant increase in Pulmonary vascular resistance (PVR) and Isoproterenol caused a significant decrease in PVR. TAH implanted calves can thus serve as a pharmacological model to study the vascular response, which may be useful in investigation of new agents with inotropic and vascular effects.     

Third model of the undulation pump total artificial heart

The undulation pump is a small, continuous flow displacement type blood pump, and the undulation pump total artificial heart (UPTAH) is a unique, implantable total artificial heart based on this pump. To improve the durability of the UPTAH for investigating long-term pathophysiology with UPTAH, a third model (UPTAH3) has been developed. UPTAH3 was designed to separate the left and right undulation shafts and to be more durable. The undulation pumps were also redesigned. UPTAH3 was implemented with a diameter of 76 mm, width of 78 or 79 mm, total volume of 292 ml, and weight of 620 g. The priming volumes of the left and right pumps are 26 and 21 ml, respectively. The atrial cuffs and outflow cannulae were also redesigned for UPTAH3. The maximum output against an arterial pressure load of 100 mm Hg is about 11 L/min. The maximum pump efficiency is about 15% in the left pump and 18% in the right pump, giving a maximum total efficiency for both of about 11%. To date, UPTAH3 has been tested in 17 goats, and the longest survival period was 46 days. This third model will be useful for investigating pathophysiology with UPTAH.     

Mechanisms of mechanical heart valve cavitation in an electrohydraulic total artificial heart

Until now, we have estimated cavitation for mechanical heart valves (MHV) mounted in an electrohydraulic total artificial heart (EHTAH) with tap water as a working fluid. However, tap water at room temperature is not a proper substitute for blood at 37 degrees C. We therefore investigated MHV cavitation using a glycerin solution that was identical in viscosity and vapor pressure to blood at body temperature. In this study, six different kinds of monoleaflet and bileaflet valves were mounted in the mitral position in an EHTAH, and we investigated the mechanisms for MHV cavitation. The valve closing velocity, pressure drop measurements, and a high-speed video camera were used to investigate the mechanism for MHV cavitation and to select the best MHV for our EHTAH. The closing velocity of the bileaflet valves was slower than that of the monoleaflet valves. Cavitation bubbles were concentrated on the edge of the valve stop and along the leaflet tip. It was established that squeeze flow holds the key to MHV cavitation in our study. Cavitation intensity increased with an increase in the valve closing velocity and the valve stop area. With regard to squeeze flow, the Bj?rk-Shiley valve, because it is associated with slow squeeze flow, and the bileaflet valve with low valve closing velocity and small valve stop areas are better able to prevent blood cell damage than the monoleaflet valves.     

叶轮泵式全人工心脏的结构设计及流体力学特性

目的通过模型样机研制和流体力学特性测试．探索以叶轮式血泵为结构基础的新型可完全植入的全人工心脏。方法全人工心脏模型样机分为左心泵和右心泵2个基本单位。2血泵均采用叶轮泵．共同设置在球形外壳中。2半球形外壳由高分子材料经激光快速成型制成．球形腔内设置固定左右心泵后对合为球形外壳．表面由医用聚氨酯橡胶涂层，直径55mm，总质量150g左右。在体外模拟循环台上对左心泵和右心泵的流体力学特性进行测试．主要观测指标为泵的转速、输出压力、流量、能耗和效率。模拟循环装置由模拟左右心房、血泵、阻力调节器、流量计串联组成，采用30％甘油水溶液作为循环介质。通过调节阻力测定特定泵转速下压力和流量。结果体外模拟测试表明全人工心脏模型样机可满足血液动力学基本要求，左心泵在9000-13000r／min转速条件下可以达到5-7L／min流量和13．3kPa（100mmHg）的压力输出，右心泵在约1／2左心泵转速和4．00kPa（30mmHg）后负荷下达到相似流量．可分别满足体、肺循环的要求。在该工作负荷条件下，2血泵的总效率约为14％。结论轴流泵作为人工心脏的血泵单位．流体力学特性可达到全人工心脏的基本要求．     

Moderate hypothermia technique for chronic implantation of a total artificial heart in calves

The benefit of whole-body hypothermia in preventing ischemic injury during cardiac surgical operations is well documented. However, application of hypothermia during in vivo total artificial heart implantation has not become widespread because of limited understanding of the proper techniques and restrictions implied by constitutional and physiological characteristics specific to each animal model. Similarly, the literature on hypothermic set-up in total artificial heart implantation has also been limited. Herein we present our experience using hypothermia in bovine models implanted with the Cleveland Clinic continuous-flow total artificial heart.