The MiniACcor: constructive redesign of an implantable total artificial heart, initial laboratory testing and further steps.

The Aachen Total Artificial Heart (ACcor) has been under development at the Helmholtz Institute in Aachen over the last decade. It may serve as a bridge to transplant or as a long-term replacement of the natural heart. Based upon previous in vivo experiments with the ACcor total artificial heart, it was decided to optimize and redesign the pump unit. Smaller dimensions, passive filling and separability into three components were the three main design goals. The new design is called the MiniACcor, which is about 20% smaller than its predecessor, and weighs only 470 grams. Also its external driver/control unit was miniaturized and a new microcontroller was selected. To validate the design, it was extensively tested in laboratory mock loops. The MiniACcor was able to pump between 4.5 and 7 l/min at different pump rates against normal physiological pressures. Several requirements for the future compliance chamber and transcutaneous energy transmission (TET) system were also measured in the same mock loop. Further optimization and validation are being performed in cooperation with the Heart and Diabetes Centre North Rhine-Westphalia.

Pressure recovery in aortic stenosis: an in vitro study in a pulsatile flow model.

OBJECTIVES: This study was designed to study pressure recovery in various models of aortic valve stenosis by performing hemodynamic measurements under physiologic conditions in a pulsatile aortic flow circuit. The results were used to validate calculations of pressure recovery based on theoretic considerations derived from fluid dynamics. BACKGROUND: Pressure recovery in aortic stenosis has not been systematically analyzed. METHODS: Stenoses varying in size, shape (circular, Y-shaped, slitlike) and inlet configuration (sharp-edged, nozzle-shaped inlet, artificially stenosed bioprostheses) were used. Aortic pressures were measured at multiple sites distal to the stenotic orifice to determine pressure gradients and recovery. RESULTS: With decreasing orifice area (2, 1.5, 1 and 0.5 cm2) pressure recovery increased (5, 7, 10 and 16 mm Hg, respectively) and the index pressure recovery to maximal peak to peak gradient decreased (56%, 37%, 24% and 14%, respectively). For a given orifice size of 0.5 cm2, this index ranged between 12% for a Y-shaped orifice and 15% for a circular orifice with a nozzle (cardiac output 4 liters/min). Increasing the cardiac output increased pressure recovery, whereas the ratio of pressure recovery to maximal pressure gradient remained constant. CONCLUSIONS: The index pressure recovery to transvalvular pressure gradient, which expresses the hemodynamic relevance of pressure recovery, decreases with increasing severity of aortic stenosis but is independent of transvalvular flow. Thus, pressure recovery is of minor importance in severe aortic stenosis but may account for discrepancies between Doppler and manometric gradients observed in patients with mild to moderate aortic stenosis or a prosthetic valve in the aortic position.

New fiber configuration for intravenous gas exchange.

Implantation of a membrane oxygenator (IO) into the vena cava for blood oxygenation in patients with acute lung failure has been researched for the last 25 years. Compared to the extra corporeal blood oxygenation, where blood is handled outside the body, IO doesn't present tubes, housings or heat exchangers, thus reducing considerably blood contact surface and setting priming volume to zero. Otherwise, restricted space in the vena cava and unadvantageous blood flow conditions represent so far a limitation for sufficient gas exchange. A new fiber configuration for intravenous use is being developed, which increases the implantable fiber surface and enhances gas exchange due to the increased blood convection. This is made possible by new fiber bundles, which are free to slide on a catheter and after implantation assume a twisted shape characterized by high homogeneity and fiber density.

Design and in vitro performance of a novel bileaflet mechanical heart valve prosthesis.

Design and in vitro performance of a novel bileaflet mechanical heart valve prosthesis are presented. The novel heart valve exhibits three main design characteristics: (i) The leaflets form a Venturi passage in open position. Thus, a beneficial pressure distribution is obtained and the leaflets are stabilised in opened position. (ii) The orifice inlet is nozzle-shaped. Flow is convectively accelerated and flow separation at the orifice inlet is avoided. (iii) The hinge design facilitates an additional axial movement of the leaflets and leads to a self cleaning effect and enhances washout of the hinges. The design of the leaflet hinges is of main importance for the functional reliability and durability of mechanical heart valves. After manufacturing first prototypes from titanium and polymeric materials the hydrodynamic performance was evaluated according to ISO 5840 and FDA guidelines. Hydrodynamic performance is comparable with the results of commonly available bileaflet mechanical heart valve prostheses. Initial durability tests showed suitable material couples for further long term studies.

In vitro comparison of aortic heart valve prostheses. Part 1: Mechanical valves.

The hydrodynamic performance of a series of mechanical heart valve prostheses is measured in the aortic position. All experiments are performed in an electrohydraulic, computer-controlled pulse duplicator simulating the left side of the human circulatory system. Testing conditions are set according to a Food and Drug Administration interlaboratory comparison protocol with cardiac outputs of 3.0, 4.5, 6.5, and 8.0 L/min at a constant heart rate of 70 beats/min. Mean systolic pressure differences, volume losses, and energy losses, as well as dimensionless pressure losses and energy loss coefficients, are calculated from the recorded pressure, volume, and flow tracings. The results of 10 mechanical heart valve prostheses (eight tilting disc valves and two bileaflet valves) are presented and their clinical relevance is discussed.

In vitro comparison of bileaflet aortic heart valve prostheses. St. Jude Medical, CarboMedics, modified Edwards-Duromedics, and Sorin-Bicarbon valves.

The hydrodynamic performance of four currently used bileaflet heart valve prostheses (St. Jude Medical, CarboMedics, modified Edwards-Duromedics, and Sorin-Bicarbon) with a nominal tissue anulus diameter of 27 mm were measured in the aortic position. All experiments were performed in nonpulsatile flow and in an electrohydraulic, computer-controlled pulse duplicator simulating the left side of the human circulatory system. Testing conditions were set at cardiac outputs of 3.0, 4.5, 6.5, and 8.0 L/min at a constant heart rate of 70 beats/min. The Sorin-Bicarbon valve had the lowest pressure difference with regard to nonpulsatile (mean 5.4 mm Hg at 30 L/min) and pulsatile (mean 2.2 mm Hg at 8 L/min) flow, followed by the St. Jude Medical, CarboMedics, and modified Edwards-Duromedics valves. The leakage volumes under static and pulsatile flow conditions were lowest for the modified Edwards-Duromedics and Sorin-Bicarbon valves. The energy loss in pulsatile flow was lowest for the Sorin-Bicarbon valve, mainly because its systolic, closure, and leakage energy losses were low. Systolic sequential velocity profiles showed the most even flow distribution pattern for the St. Jude Medical and Sorin-Bicarbon valves. These findings correspond with lower overall Reynolds shear stress levels for the St. Jude Medical and the Sorin-Bicarbon valves than for the modified Edwards-Duromedics and CarboMedics valves.

Dynamic in vitro calcification of bioprosthetic porcine valves: evidence of apatite crystallization.

OBJECTIVE: Calcification is the most important cause of structural deterioration of glutaraldehyde-fixed bioprosthetic valves. Devitalization of tissue favors calcium deposits in the shape of apatite crystals. Host factors influence the extent and progression of calcification, but the phenomenon can also occur in vitro in the absence of a viable milieu. Whether calcific deposits obtained in vitro are similar to those found in vivo is unknown. METHODS: Four porcine frame-mounted bioprostheses (St Jude Medical Bioimplant; St Jude Medical, Inc, St Paul, Minn) were tested in vitro by using a pulsatile accelerated calcification testing device at a frequency of 300 cycles per minute at 37 degrees C for 19 x 10(6) cycles with a rapid synthetic calcification solution (final product [calcium x phosphate], 130 mg/dL(2)). Three of the same type of xenografts explanted from human subjects because of calcific failure (time in place, 108 +/- 25.63 mo) served as control grafts. Each sample underwent gross and x-ray examination, histology, transmission and scanning electron microscopy, atomic absorption spectroscopy, electron microprobe analysis, and x-ray powder diffraction methods. RESULTS: All in vitro bioprostheses were heavily calcific, with intrinsic Von Kossa stain-positive deposits and a mean calcium content of 205.285 +/- 64.87 mg/g dry weight. At transmission electron microscopy, nuclei of calcification involved mostly collagen fibers and interfibrillar spaces and, more rarely, cell debris and nuclei. Electron microprobe analysis showed a Ca/P atoms ratio of 4.5:3, a value intermediate between hydroxyapatite and its precursor, octacalciumphosphate. X-ray powder diffraction showed a well-separated and sharp peak, which is typical of hydroxyapatite. Aggregates of plate-like crystals up to 8 microm in size were observed at scanning electron microscopy, with a typical tabular hexagonal shape consistent with apatite. The morphologic and chemical findings in human explants were similar. CONCLUSIONS: Intrinsic calcification of glutaraldehyde-fixed porcine valves was induced in vitro. Electron microprobe analysis and x-ray powder diffraction findings were in keeping with apatite crystallization, such as that occurring in valve xenografts implanted in vivo. The model may be of value to accelerate the screening of anticalcific agents and may reduce the need for animal experiments.

Clinical experience with the MEDOS HIA-VAD system in infants and children: a preliminary report.

BACKGROUND: The need of pediatric cardiac assist is growing because of the complexity of the congenital conditions operated on and the increasing number of pediatric transplantations. We evaluated the newly developed pediatric MEDOS HIA-VAD ventricular assist device. METHODS: The pneumatic paracorporeal ventricular assist device has three left ventricular sizes (10-, 25-, and 60-mL maximum stroke volume) and three right ventricular sizes (9, 22.5, and 54 mL) and can be operated effectively with up to 180 cycles/min. We used this device in 6 consecutive pediatric patients. Intention of treatment was to bridge to transplantation in 3 patients and to aid in recovery from a cardiac operation in 3. Age ranged from 5 days to 8 years. RESULTS: Two children died during assist, 2 were weaned from the system and discharged home, and 2 had successful transplantation. During assist, laboratory variables indicative of impaired renal, hepatic, or pulmonary function normalized or showed a trend toward normalization. Both deaths were related to infection. CONCLUSIONS: With the new MEDOS HIA-VAD ventricular assist device system, pediatric mechanical cardiac assist can be performed successfully. It requires timely implantation, careful monitoring, and adequate size-matched devices.

In vitro testing of bioprostheses: influence of mechanical stresses and lipids on calcification.

BACKGROUND: Structural valve deterioration of bioprostheses is mainly caused by the progressive development of calcification. Mechanical stresses or lipid deposits in porcine aortic leaflets have been proposed as major factors contributing to the calcification process. METHODS: A new test protocol consisting of nondestructive holographic interferometry, which allows a quantitative deformation analysis of heart valves, and accelerated dynamic in vitro calcification was used. The rapid calcification fluid contained a final combined calcium and phosphorus concentration of 130 (mg/dL)2 in barbital buffer solution. The calcification of 32 bioprostheses donated by different manufacturers (SJM Bioimplant, Biocor standard, Biocor No-React, Carpentier-Edwards SAV, Bravo, pericardial prototype) was assessed after up to 25 x 10(6) cycles by microradiography and the areas of calcification were compared with the holographic interferograms. The distribution of lipid droplets of four porcine prostheses were visualized by Sudan III stain before the calcification process. RESULTS: Most of the tested bioprostheses had areas presenting with stress concentrations, and the dynamic in vitro testing resulted in leaflet calcification corresponding to the holographic irregularities. A strong correlation between calcification and stress distribution or lipid accumulation was found (r = 0.72; r = 0.81, respectively). After 19 x 10(6) cycles, the Carpentier-Edwards SAV and the pericardial valves had significantly less calcification than other prostheses tested (p = 0.003), but the variation among individual prostheses from the same manufacturer was even more pronounced. CONCLUSIONS: Mechanical stresses or lipid accumulation seems to play an important role in the calcification process of bioprostheses. Quality control of bioprosthetic valves using holographic interferometry has the potential to predict calcification before implantation.

Three-dimensional echocardiographic determination of left ventricular volumes and function by multiplane transesophageal transducer: dynamic in vitro validation and in vivo comparison with angiography and thermodilution.

The goal of this study was to validate 3-dimensional echocardiography by multiplane transesophageal transducer for the determination of left ventricular volumes and ejection fraction in an in vitro experiment and to compare the method in vivo with biplane angiography and the continuous thermodilution method. In the dynamic in vitro experiment, we scanned rubber balloons in a water tank by using a pulsatile flow model. Twenty-nine measurements of volumes and ejection fractions were performed at increasing heart rates. Three-dimensional echocardiography showed a very high accuracy for volume measurements and ejection fraction calculation (correlation coefficient, standard error of estimate, and mean difference for end-diastolic volume 0.998, 2.3 mL, and 0.1 mL; for end-systolic volume 0.996, 2.7 mL, and 0.5 mL; and for ejection fraction 0.995, 1.0%, and -0.4%, respectively). However, with increasing heart rate there was progressive underestimation of ejection fraction calculation (percent error for heart rate below and above 100 bpm 0.59% and -8.6%, P < .001). In the in vivo study, left ventricular volumes and ejection fraction of 24 patients with symmetric and distorted left ventricular shape were compared with angiography results. There was good agreement for the subgroup of patients with normal left ventricular shape (mean difference +/-95% confidence interval for end-diastolic volume 5.2+/-6.7 mL, P < .05; for end-systolic volume -0.5+/-8.4 mL, P = not significant; for ejection fraction 2.4%+/-7.2%, P = not significant) and significantly more variability in the patients with left ventricular aneurysms (end-diastolic volume 23.1+/-56.4 mL, P < .01; end-systolic volume 5.6+/-41.0 mL, P = not significant; ejection fraction 4.9%+/-16.0%, P < .05). Additionally, in 20 critically ill, ventilated patients, stroke volume and cardiac output measurements were compared with measurement from continuous thermodilution. Stroke volume as well as cardiac output correlated well to thermodilution (r = 0.89 and 0.84, respectively, P < .001), although both parameters were significantly underestimated by 3-dimensional echocardiography (mean difference +/-95% confidence interval = -6.4+/-16.0 mL and -0.6+/-1.6 L/min, respectively, P < .005).

Three-dimensional visualization of velocity fields downstream of six mechanical aortic valves in a pulsatile flow model.

Velocity fields downstream of 27 mm Björk-Shiley Standard, Björk-Shiley Convex-Concave, Björk-Shiley Monostrut, Hall-Kaster (Medtronic-Hall), St. Jude Medical and Starr-Edwards Silastic Ball aortic valves were studied in a pulsatile mock circulation. Stroke volume was 70 cm3 and frequency 71 min-1 and 88 min-1. Fluid velocity was measured by a catheter mounted hot-film anemometer probe in a glycerol water mixture one and two diameters downstream of the aortic valve. Velocity fields were dynamically visualized by a three-dimensional technique and revealed qualitative independence of frequency. All profiles were flat in the acceleration phase of systole. From peak systole and throughout the systolic deceleration phase profiles characteristic of the individual valves appeared. The pivoting and tilting disc valves caused a skewed velocity profile with highest velocities downstream of the major orifice and lowest velocities downstream of the minor orifice. The differences between the three investigated Björk-Shiley valves were remarkable. The St. Jude Medical valve generated velocity peaks downstream of the two major orifices and the central slit, and lower velocities in the hinge areas. A rather flat profile with central hollowing was seen downstream of the Starr-Edwards Ball valve. All velocity profiles were more or less dampened two diameters downstream.

In vitro stress measurements in the vicinity of six mechanical aortic valves using hot-film anemometry in steady flow.

Based on hot-film anemometry, point velocity measurements in the total cross sectional area 1 and 2 diameters downstream of: Björk-Shiley Standard, Convex-Concave and Monostrut, Hall-Kaster (Medtronic-Hall), St. Jude Medical and Starr-Edwards Silastic Ball aortic valves were made. The spatial distribution of Reynolds Normal Stresses (RNS) was visualized three-dimensionally in order to point out where and to what extent the highest RNSs were found. The measurements were made in steady flowing glycerol mixture at flow rates 10, 20 and 30 l. min-1 corresponding to mean velocities of 27, 54 and 81 cm s-1. The highest maximum RNS values were around 250 Nm-2 and were found downstream of the Björk-Shiley Monostrut and Starr-Edwards Ball valves. The lowest maximum RNSs were found downstream of the St. Jude Medical and Hall-Kaster (Medtronic-Hall) valves (125-140 Nm-2). The Starr-Edwards valve had the highest mean RNS (117 Nm-2) followed by the Björk-Shiley Monostrut (87 Nm-2). These simplified measurements of artificial heart valve performances concerning RNS, enhance the interpretation of results in more complicated flow models not to say in vivo.

Turbulent stress measurements downstream of six mechanical aortic valves in a pulsatile flow model.

In a pulsatile flow model aortic Björk-Shiley Standard, Convex-Concave and Monostrut valves were investigated together with the Hall-Kaster (Medtronic-Hall), St Jude Medical and Starr-Edwards Silastic Ball valve using hot-film anemometry. Three-dimensional visualization of average systolic Reynolds normal stresses (RNS) reflected the design of the valves. Mean average RNS were used for comparison of the fluid dynamic performance along with Velocity Energy Ratio (VER100) and Turbulence Energy Ratio (TER) as a relative turbulence intensity for pulsatile flow. Mean average RNS ranged from 13.2 to 37.6 Nm-2 for all the valves with the highest levels for the Björk-Shiley Standard and Starr-Edwards Ball valve and lowest values for the St Jude Medical valve and with the Hall-Kaster (Medtronic-Hall), Björk-Shiley Convex-Concave and Monostrut valves in between.

Estimation of turbulent shear stresses in pulsatile flow immediately downstream of two artificial aortic valves in vitro.

Measuring turbulent shear stresses is of major importance in artificial heart valve evaluation. Bi- and unidirectional fluid velocity measurements enable calculation of Reynolds shear stress [formula: see text] and Reynolds normal stress [formula: see text]. tau is important due to the relation to hemolysis and thrombus formation, but sigma is the only obtainable parameter in vivo. Therefore, determination of a correlation factor between tau and sigma is pertinent. In a pulsatile flow model, laser Doppler (LDA) and hot-film (HFA) anemometry were used for simultaneous bi- and unidirectional fluid velocity measurements downstream of a Hall Kaster and a Hancock Porcine aortic valve. Velocities were registered in two flow field locations and at four cardiac outputs. The velocity signals were subjected to analog signal processing prior to digital turbulence analysis, as a basis for calculation of tau and sigma. A correlation factor of 0.5 with a correlation coefficient of 0.97 was found between the maximum Reynolds shear stress and Reynolds normal stress, implying [formula: see text]. In vitro estimation of turbulent shear stresses downstream of artificial aortic valves, based on the axial velocity component alone, seems possible.

The geometry of the aortic root in health, at valve disease and after valve replacement.

For the design of aortic valve prostheses with a separation-free flow field and minimum pressure drop the geometry of the aortic root is of high importance, since an appropriate adjustment of the prostheses to the surrounding geometry could largely reduce the risk of thromboembolic complications. For the investigation of the geometry of the aortic root 604 angiographic films out of a total stock of 15,000 of the Medical Clinic I were evaluated. The film material was preclassified into five clinical categories according to the patient's data. For each category characteristic geometries could be derived in non-dimensional form.

In-vitro wall shear measurements at aortic valve prostheses.

Wall shear distributions during the cardiac cycle at the valve rings of Starr-Edwards, Björk-Shiley and Lillehei-Kaster aortic valves are measured and compared with thresholds reported for shear-induced trauma of blood components. Further, for the disk valves, the influence of pulse rate on wall shear stresses is evaluated. Hot film anemometry with flush-mounted wall shear probes is used as measurement technique in a pulsatile flow mock circuit. The experimental systolic data support the better hemodynamic characteristics of the disk valves over the ball valve also with respect to the threshold shear stresses of flow induced blood trauma. These results are confirmed by postoperative clinical studies, where lower LDH-values are found with the disk than with the ball valves. During diastole, however, high shear stresses are measured and calculated at the valve ring of the Björk-Shiley prosthesis, which can be referred to the non-overlapping closing mechanism. This result is discussed with respect to the often observed thrombus formation at the disk downstream of the smaller orifice of the Björk-Shiley valve.

Three-dimensional visualization of axial velocity profiles downstream of six different mechanical aortic valve prostheses, measured with a hot-film anemometer in a steady state flow model.

Hot-film anemometry was used for in vitro steady-state measurements downstream of six mechanical aortic valve prostheses at flow rates 10, 20 and 30 l.min-1. Three-dimensional visualizations of velocity profiles at two downstream levels were made with the valves rotated 0 and 60 degrees in relation to the sinuses of valsalvae. The velocity fields downstream of the disc valves were generally skew with increasing velocity gradients and laminar shear stresses with increasing flow rates. Furthermore, increased skewness of the velocity profiles was noticed when the major orifices of the disc valves were towards the commissure than when approaching a sinus of valsalvae. The velocity profiles downstream of the ball valve were generally flat but with considerably more disturbed flow, consistent with the findings in turbulent flow.

Two-dimensional color-mapping of turbulent shear stress distribution downstream of two aortic bioprosthetic valves in vitro.

Since artificial heart valve related complications such as thrombus formation, hemolysis and calcification are considered related to flow disturbances caused by the inserted valve, a thorough hemodynamic characterization of heart valve prostheses is essential. In a pulsatile flow model, fluid velocities were measured one diameter downstream of a Hancock Porcine (HAPO) and a Ionescu-Shiley Pericardial Standard (ISPS) aortic valve. Hot-film anemometry (HFA) was used for velocity measurements at 41 points in the cross-sectional area of the ascending aorta. Three-dimensional visualization of the velocity profiles, at 100 different instants during one mean pump cycle, was performed. Turbulence analysis was performed as a function of time by calculating the axial turbulence energy within 50 ms overlapping time windows during the systole. The turbulent shear stresses were estimated by using the correlation equation between Reynolds normal stress and turbulent (Reynolds) shear stress. The turbulent shear stress distribution was visualized by two-dimensional color-mapping at different instants during one mean pump cycle. Based on the velocity profiles and the turbulent shear stress distribution, a relative blood damage index (RBDI) was calculated. It has the feature of combining the magnitude and exposure time of the estimated shear stresses in one index, covering the entire cross-sectional area. The HAPO valve showed a skewed jet-type velocity profile with the highest velocities towards the left posterior aortic wall. The ISPS valve revealed a more parabolic-shaped velocity profile during systole. The turbulent shear stresses were highest in areas of high or rapidly changing velocity gradients. For the HAPO valve the maximum estimated turbulent shear stress was 194 N m-2 and for the ISPS valve 154 Nm-2. The RBDI was the same for the two valves. The turbulent shear stresses had magnitudes and exposure times that might cause endothelial damage and sublethal or lethal damage to blood corpuscules. The RBDI makes comparison between different heart valves easier and may prove important when making correlation with clinical observations.

Durability/wear testing of heart valve substitutes.

BACKGROUND AND AIMS OF THE STUDY: The current standards for accelerated heart valve testing have considerable differences in test conditions. Another problem arises from the fact that such test systems are not standardized at all. It was shown earlier that different test systems generate totally different valve loading, even if operating at standard conditions. The present study aimed to improve this unsatisfactory situation and to develop a new concept where actual loading of valves is measured either in vitro or in vivo under physiologic conditions and subsequently to reproduce these conditions during accelerated testing. METHODS: Integral loading forces at valve closure were measured for several valve types using a piezoelectric force ring within a real-time circulatory mock loop under physiologic conditions. This facilitated definition of a physiologic loading range. Physiologic loading was subsequently reproduced in a single-chamber accelerated test system. Working conditions obtained in terms of stroke, bypass flow and compliance served as design criteria for a new test chamber and a complete 12-chamber accelerated testing system. RESULTS: The integral loading obtained using the force ring showed a correlation with previous in vitro and in vivo results of strain-gauged valves. Loading forces for mechanical valves are about one order of magnitude higher than for bioprosthetic valves and are strongly related to cardiac output for both valve types. At physiologic loading, however, the differential pressures across the valves are considerably below those given in FDA guidelines. CONCLUSIONS: This pilot study demonstrates that physiologic valve loading is reproducible over a wide range under appropriate testing conditions. It also showed that, at the back-pressures of the current standards, the loading forces during accelerated testing exceed the real-time loading forces by far and, thus, may provide unrealistically high valve loads. These initial findings indicate that amendments of the currently valid standards may be need to be accorded.

Prosthetic valve function under simulated low cardiac output conditions: preliminary observations.

An experimental protocol was developed and a series of laboratory experiments started to assess the function and behaviour of replacement valves under simulated low cardiac output, that is low flow and low pressure conditions. The Helmholtz Institute's pulse duplicator (1) and instrumentation were carefully tuned in order to achieve accurate and reproducible delivery of the required extremely small stroke volumes. A pilot study was completed with 27 mm St. Jude Medical and CarboMedics bileaflet valves and Wessex porcine bioprostheses, three each, in the simulated aortic position. The results of these experiments suggest that the performances of the two bileaflet prostheses are inadequate if the flow is less than 2.0 l/min; the porcine bioprosthesis needs relatively low flow to start proper function, but its stenotic nature soon becomes apparent; increase in pressure without a corresponding increase in flow has a deleterious effect on valve performances by increasing regurgitation; increasing pulse rate is inversely correlated with valve efficiency; and there is no "all-or-none" cut off point between functional and non-functional situation for the tested devices; there is a semilogarithmic relation between increasing flow and valve performance. The clinical consequences are manifold and may be related both to the stabilization of circulation and to the increased thromboembolic risk during the early postoperative period.