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.     

Retrieval and analysis of a clinical total artificial heart

Examination by light microscopy, scanning electron microscopy (SEM), and x-ray microanalysis of a clinical total artificial heart (TAH) implanted for 112 days revealed no evidence of calcification, pannus, or vegetative thrombus. A macroscopic thrombus was seen along the suture line in the right atrium but did not obstruct blood flow or valve function. Microscopic thrombi (less than 0.1 mm) and evidence of microemboli were observed on the pumping diaphragm using SEM. Characterization of selected polyetherurethane (PEU) samples from the pumping bladders and housing by Curie-point pyrolysis mass spectrometry (Py-MS) revealed unexpected differences between postmortem retrieved ventricles. Although the origin of these differences could be traced back to batch-to-batch variations in the original PEU material (Biomer), the precise nature of the observed differences in chemical structure and/or composition is still unknown. Numerical comparison between pyrolysis mass spectra from PEU samples exposed to blood or tissue and unexposed samples from the same ventricles did not detect evidence of biodegradation. Continual improvements in fabrication and quality control should minimize surface imperfections and ensure polymer reproducibility; however, existing materials and design parameters appear to be adequate for continued clinical implantation.     

Implantation of a Berlin Heart as single ventricle by-pass on Fontan circulation in univentricular heart failure

The clinical management of ventricular failure after the Fontan operation presents a formidable challenge to surgeons. We report our experience with successful implantation of a Berlin Heart EXCOR ventricular assist device as a bridge to transplantation in a child with Fontan circulation.     

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.     

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.     

Mayer waves in dogs with total artificial heart.

To assess the effect of a total artificial heart (TAH) on the autonomic nervous system a power spectral analysis of the hemodynamics in a TAH animal was done by the maximum entropy method. Two pneumatically driven sac-type ventricular assist devices were implanted as total biventricular bypass (BVB) in adult mongrel dogs to compare the differences between natural heart and TAH. Once the BVB was pumping, the natural heart was electrically fibrillated to constitute the BVB-type TAH model. In the arterial pressure waveform in animals with TAH, respiratory waves were not changed (97.7 +/- 24.6%) though Mayer waves were significantly decreased (47.5 +/- 22.6%) compared with the animal with a natural heart. These results suggest that prosthetic hemodynamics in the TAH animal affect fluctuations in the cardiovascular system.     

Experience with vascular grafts in total artificial heart replacement

In total artificial heart replacement the pumps are attached to the vascular system with the help of connectors. These consist of a woven Dacron vessel graft to which a short silastic segment is vulcanized. In 36 calves surviving total artificial heart replacement between one and seven months (average 85 days) the morphological alterations due to interfacial reactions were studied: thrombus formation and neointimal fibrous hyperplasia at the anastomoses. In 15 calves (41.7%) thrombus growth within the outflow tract led to anastomotic stenosis: pulmonary artery 14 (93.3%), aorta-anastomosis 1 (2.8%), both vessels 1 (2.8%), in combination with pannus growth in atrial location 13 (86.7%). In 73.3% the pannus consisted of infected organized thrombus imitating the course of septic vegetative endocarditis. Two calves were reoperated in order to remove the vegetative thrombi, one successfully. In five animals pulmonary stenosis was the main cause of death. The presence and location of excessive tissue growth and thrombus formation within the outflow tract are also inherent to the fluid mechanical design of the valve. Neointimal fibrous hyperplasia at the anastomoses of the grafts seems to be a reparative process started up by platelet-induced subendothelial cell proliferation in response to intimal injuries.     

Cavitation phenomenon in monoleaflet mechanical heart valves with electrohydraulic 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. In this study, to investigate the mechanism of cavitation bubbles associated with monoleaflet mitral valves in an electrohydraulic total artificial heart (EHTAH), and to select the best valves for our EHTAH system, we measured three parameters. First, an image was created of the cavitation bubbles using a high-speed camera. Second, pressure drop in the vicinity of the valve surface was measured using mini pressure sensor. Then, the closing of the valve was observed using a Laser displacement sensor. Most of the cavitation bubbles in the Medtronic Hall valve were observed at the edge of the valve stop. With the Omnicarbon valve, the cavitation bubbles were observed at the edge of the valve and on the inner side of the leaflet. On the other hand, cavitation bubbles were observed only on the inner side of the leaflet in Bj?rk-Shiley valve. Cavitation bubbles concentrated on the edge of the valve stop; the major cause of these cavitation bubbles was determined to be the squeeze flow. The formation of cavitation bubbles depended on the valve closing velocity and the valve leaflet geometry. From a viewpoint of squeeze flow, a low closing velocity and a small size of the valve stop could minimize cavitation.     

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.     

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.     

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.     

Hemodynamics of a functional centrifugal-flow total artificial heart with functional atrial contraction in goats

Implantation of a total artificial heart (TAH) is one of the therapeutic options for the treatment of patients with end-stage biventricular heart failure. There is no report on the hemodynamics of the functional centrifugal-flow TAH with functional atrial contraction (fCFTAH). We evaluated the effects of pulsatile flow by atrial contraction in acute animal models. The goats received fCFTAH that we created from two centrifugal-flow ventricular assist devices. Some hemodynamic parameters maintained acceptable levels: heart rate 115.5 ± 26.3 bpm, aortic pressure 83.5 ± 10.1 mmHg, left atrial pressure 18.0 ± 5.9 mmHg, pulmonary pressure 28.5 ± 9.7 mmHg, right atrial pressure 13.6 ± 5.2 mmHg, pump flow 4.0 ± 1.1 L/min (left) 3.9 ± 1.1 L/min (right), and cardiac index 2.13 ± 0.14 L/min/m². fCFTAH with atrial contraction was able to maintain the TAH circulation by forming a pulsatile flow in acute animal experiments. Taking the left and right flow rate balance using the low internal pressure loss of the VAD pumps may be easier than by other pumps having considerable internal pressure loss. We showed that the remnant atrial contraction effected the flow rate change of the centrifugal pump, and the atrial contraction waves reflected the heart rate. These results indicate that remnant atria had the possibility to preserve autonomic function in fCFTAH. We may control fCFTAH by reflecting the autonomic function, which is estimated with the flow rate change of the centrifugal pump.