J Artif Organs (1999) 2:46-52

@The Japanese Societyfor Artificial Organs 1999

Zhonggang Feng, PhD 9 Mitsuo Umezu, PhD Tetsuo Fujimoto, MD 9 Toshiya Tsukahara, MS Masakazu Nurishi, MS 9 Daisuke Kawaguchi, BS Shinya Masuda, BS

Analysis of ATS leaflet behavior by in vitro experiment

Abstract It has been reported that the normally functional bileaflet valve ATS with open-pivot design does not exhibit a full opening motion either in the mitral or in the aortic position in patients. An in vitro experiment was conducted to investigate the mechanism of the ATS leaflet movement. ATS 29 mm for the mitral position was chosen in our experiment and SJM 29ram was chosen as a control. Two pulsatile simulators were employed to investigate the factors affecting leaflet movement. Two different conduits to be incorporated downstream (in simulator I) and three different inlet coverings to alter the local flow field around the open pivot (in simulator II) were used. A high-speed video camera was employed to observe leaflet movement. The ATS valve could exhibit a fully open movement in straight conduit but could not fully open when an enlarging shape was incorporated downstream of the ATS valve9 The covering of the ATS open pivot could make the leaflets fully open or increase the opening angle with the existence of the enlarging downstream shape. The enlargement downstream of the ATS valve, which induces a divergent transvalvular flow, is the main reason that the leaflets do not fully open. The local flow field around the open pivot, which induces an additional moment Ma, plays an important role in the movement of the ATS leaflets. Key words Bileaflet valve 9In vitro test. Leaflet movement 9Influence of conduit shape 9Pivot effect

Introduction
Modern prosthetic heart valves are generally considered to be safe and efficient devices for replacement of malfuncReceived: October 22, 1998 / Accepted: March 23, 1999 z. Feng ([]) 9M. Umezu 9T. Fujimoto 9T. Tsukahara - M. Nurishi . D. Kawaguchi. S. Masuda Depertment of Mechanical Engineering, Waseda University, 3-4-1 Ohkubo, Shinjuku, Tokyo 169-8555,Japan Tel. +81-3-5286-3256;Fax +81~3-3200-2516 e-mail: iac97050@mn.waseda.ac.jp

tioning natural valves. Currently, a number of clinicalquality types of mechanical valves are available in the market. It is of considerable interest to compare the hemodynamic characteristics among these valves. 1-3 In this aspect, the in vitro hydrodynamic test is a main approach to compare and evaluate the hydrodynamic characteristics, which usually include pressure gradient, closing volume, and leakage. In this kind of experiment, the pulsatile simulator is a key apparatus. At present, the macroscopic functions of the pulsatile duplicator, such as the pressure waveform, flow waveform, and cardiac output, are addressed very well. Nevertheless, the flow field around a valve mounted in a testing duplicator is still quite different from that in a natural heart. This flow field difference may lead to differences in the behavior of the valve between in vitro and in vivo conditions. The recent in vivo investigation by Aoyagi et al. 4 also indicated that the effect of this difference on the leafet movement of the ATS valve with open-pivot design could not be ignored. In the clinical evaluation of the ATS open-pivot bileaflet valve, the valves normally performed and presented less pressure gradient than the SJM valve. But the opening angles of these normally functioning ATS valves were less than that designed by the manufacturer and that observed in vitro: the ATS valve did not open fully in the patients. 4 Aoyagi pointed out that the location of the pivot was within the orifice and the axis of suspension of the leaflet was closer to the straight edge, so that leaflets of the ATS valve extended somewhat farther from the orifice ring than other valves9 It was speculated that unevenly distributed blood flows through three orifices of the ATS valve as well as the above factors might result in incomplete opening of the ATS valve. In order to clarify the mechanism of the movement of the ATS valve further, two types of pulsatile simulators were employed to investigate the factors affecting the movements of the ATS leaflets. By using simulator I, the influence of different conduit shapes downstream could be studied; by using simulator II, the opening angle could be measured precisely. Furthermore, the effects of the different types of covered ATS on the local flow around the open pivot were investigated. It was found that the flow field

47 downstream as well as the local flow field around the open pivot prevented the ATS from opening fully. the mitral position of the pulsatile simulators. Figure 3 shows that the ATS covered type I only covers the orifice ring but exposes the open-pivot parts, so that the inlet flow is able to rush directly into the open-pivot region. In the original ATS valve, the inlet flow has to cross over the orifice ring edge. Therefore, the covered type I could strengthen the flow effect in the open pivot. The covered type II sheltered half of the pivot area, and the covered type III hid all of the open pivot. All of the covering sizes in Fig. 2 were controlled precisely and the coverings did not decrease the area of the ATS orifice. Testing simulators The testing devices included two different types of pneumatically driven pulsatile simulators developed in our laboratory (Figs. 4 and 5). The valves were tested in the mitral position. In the simulator I (pneumatically driven tube pump), two different conduits, straight and abrupt enlargemerit (Fig. 4b), were incorporated downstream of the mitral valve respectively to investigate the effects of different flow patterns on leaflet movement. The straight conduit could entirely contain the valve leaflets in the straight part, and the tapered part of it was merely to match the diameter of the ventricle chamber. In simulator II (pneumatically driven sac pump), the tested valve was mounted in such a way that it directly faced the expanding ventricular sac. The shape downstream, therefore, was also a somewhat abrupt enlargement. The high-speed camera could record the movement in the axial direction of the valve in this simulator, so the opening angle of the whole movement process could be calculated afterwards by measuring the disk length on the video pictures. Experimental conditions
(a) (b)

Materials and methods

Tested valves One ATS 2 9 m m (Standard Cuffed Valve for mitral position, ATS Medical, Minneapolis, MN, USA) was chosen in our experiment and an SJM 29mm (Masters Series Standard Cuffed Valve for mitral position, St. Jude Medical, St. Paul, MN, USA) as a control. Both have a tissue annulus diameter of 29 mm. In the ATS valve, the movement of the leaflets is restricted by the open-pivot configuration, which, differing from the traditional concave-pivot structure in the SJM valve, is composed of a spherical convex pivot and three other convex pivot stoppers on the inner circumference of the orifice ring (Fig. 1). One can suppose that the flow around the open pivot should be quite different from that in the SJM valve. In order to investigate the influence of the different local pivot flow fields on leaflet movement, three modifications of the original ATS valve, called the covered type (Fig. 2), were involved in our study. In these covered ATS valves, the open-pivot area was covered to different extents by the silicone housing, in which the ATS valve was mounted in

stoppers

Fig. 1. Schematic drawing of ATS valve configuration (a) and ATS open-pivot structure (h)

The experiments were conducted at cardiac output of about 51/min at a pulse rate of 60 beats/min, with aortic pressure maintained at 125/80mmHg, and a systolic fraction of 35%. Details of the test apparatus and the typical testing waveOrifice ring Orifice ring

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CoveredtypeIlI Fig. 3a-c. Different local flows into the open pivot between the original ATS valve and the ATS covered type I valve, a Orifice ring, b Original ATS, c ATS covered type I

Fig. 2. Different configurations of inlet covers for the ATS valve employed in the experiment

48 HSC

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Fig.5. Schematicdiagramof pulsatilesimulatorII (pneumatically

driven sac pump) employed in the experiment. CT, compliance tank; PR, peripheral resistance; FM, flow meter; APG, aortic pressure gradient; MPG, mitral pressure gradient; HSC, high-speed video camera; AS, atrial sac; VS, ventricular sac; AV, aortic valve; MV, mitral valve

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valve could achieve a full opening movement only in the very late period of ventricular diastole in the straight conduit. (3) The ATS valve could not open fully in the abrupt enlargement conduit. (4) When the open pivot of the ATS valve was covered by type III, it could exhibit a full opening movement in the abrupt enlargement conduit. Results with simulator II (pneumatically driven sac pump) Figure 6 shows the leaflet movement of the original ATS valve (Fig. 6a) and of the ATS covered type II (Fig. 6b). The flow patterns (Fig. 6c) and transvalvular pressure differences (Fig. 6d) during diastole are also depicted. The flow patterns and transvalvular pressure gradients of the original ATS valve and the ATS covered type did not differ much. We cannot even distinguish between the pressure gradient in the original ATS valve and the ATS covered-type valve in Fig. 6d. As shown in Fig. 6a, an asymmetric opening angle of the two leaflets of the original ATS valve was frequently observed, and the opening angle could vary during the whole diastole. The covered type II could increase the opening angle and reduce the asymmetry (Fig. 6b). The effects of all coverings are shown clearly in Fig. 7, which presents the average values of the maximal opening angle (MOA) of each leaflet during 24 continuous pulses as well as the standard deviation (SD) of the MOA. It can be seen that in simulator II the original ATS valve and all of the covered types did not fully open. However, as compared with the original ATS valve, the covered type II and the covered type III increased the MOA to nearly fully while then SDs decreased, whereas the covered type I decreased the MOA and increased the SD.

Fig. 4. Schematicdiagramof pulsatilesimulatorI (pneumatically

driven tube pump) employed in the experiment, a Pulsatile simulator I (pneumatically driven tube pump), b Two different downstream conduits

forms are given by Fujita and Umezu 3 and by Umezu et al. s The testing fluid was 0.9% saline. The electromagnetic flowmeter (Nihon Kohden, Tokyo, Japan, MFV-2100) and the strain gauge-type pressure transducers (Baxter, UK801) were employed in the experiments. The movement of the valve leaflets was recorded by a high-speed video camera (Fastcam-ultima, Photron, Tokyo) at 125 frames/s.

Results
Results with simulator I (pneumatically driven tube pump) Leaflet movement was observed with the aid of the highspeed camera in the direction parallel to the leaflet suspension axis. The leaflet suspension axis was vertically located to diminish the influence of gravity. The following observations were made. (1) The SJM valve could make a full opening movement in both conduits. (2) The ATS

49

Fig. 6. Transient leaflet movement of original ATS (a) and ATS covered type II (b) in pulsatile simulator II. e and d present the mitral flow rate through the valves and the transvalvular pressure gradient, respectively

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Analysis
Effect of the d o w n s t r e a m flow on the m o v e m e n t of the A T S valve It is easy to u n d e r s t a n d that the A T S valve r e s p o n d e d to the divergent transvalvular flow resulting from the a b r u p t e n l a r g e m e n t d o w n s t r e a m so as to not o p e n fully. Especially, the leaflets of the A T S valve extend farther from the orifice ring to the d o w n s t r e a m because the location of the pivot is within the orifice and the axis of suspension of the leaflet is closer to the straight edge. It results in the leaflets of the A T S valve responding with great sensitivity to the outlet flow. Therefore, in the straight conduit the original A T S valve could achieve a fully o p e n movement, but in the a b r u p t e n l a r g e m e n t conduit the original A T S valve could not achieve a fully o p e n movement. In summary, the divergent d o w n s t r e a m flow is the most important factor leading to the failure of the leaflets to open fully. F u r t h e r m o r e , by means of the covered A T S valves, a n o t h e r finding in this study is that the local flow field a r o u n d the o p e n pivot also plays an i m p o r t a n t role in leaflet movement.

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85

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80

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75

70 ATS CoverecI type I

Covered type II Covered type III

Fig. 7. Maximal opening angle (MOA) and standard deviation (SD) of the ATS valve and ATS covered valves

50 Effect of the open Pivot on the movement of the ATS valve Figure 8 illustrates the influence of the local pivot flow field on leaflet movement. The suspension axis, which is the contact point between the leaflet and the spherical pivot, is not at the center of the pivot but at its upper position (position of contact point "a"). There are two low-velocity and squeezing regions between the leaflet and the stoppers. These regions are located above and below the suspension axis, respectively, while they are located on either side of the leaflet, respectively. When flow rushes into these regions, it will decelerate for two reasons. First, these regions are constituted by the convex stoppers and leaflet so that they act as obstacles to the flow. Second, the Reynolds number of the flow in these regions is much smaller than that in the orifice flow (the estimate of the Reynolds number is less than 10), so the effect of viscous resistance in these regions will further slow the flow. Accompanying the above two factors, the fluid rushing into these regions will be squeezed as the leaflets open. All these factors increase the pressure in these low-velocity and squeezing regions. This pressure increase can induce an additional moment Ma tending to close the leaflets, called the pivot effect in the ATS valve (Fig. 8a). To explain the additional moment Ma further, we can imagine the case when the ATS leaflets are fully open (Fig. 8b). In this case, the leaflet and the stoppers completely contact and there is no space between them. Therefore, the flow will decelerate and stagnate in the lowvelocity and squeezing regions, and as a counteraction of this deceleration, the stagnated fluid will push the leaflet away from the stoppers, i.e., producing the additional moment Ma in the direction that closes the leaflet.

Mechanism of movement of the ATS valve During diastole (with the valve in the mitral position), an opening moment Mo, due to the pressure difference between the two sides of the leaflet, turns the leaflets to open. At the same time, the pivot effect gives rise to the additional moment M a in the direction that closes the leaflet. Consequently, the net opening moment should be equal to MoMa. In order to explain the mechanism of the ATS leaflet movement, the variation of these moments is qualitatively analyzed, as shown in Fig. 9. As the leaflet opens, Ma (dashed curve) will increase due to the low-velocity and squeezing effect becoming strong, while the Mo will decrease due to the pressure difference between the two sides of the leaflet becoming small. However, the decrease of Mo will be different with the different conduit shape at the downstream of the valve. In the straight conduit, the Mo changes like the solid curve 1 in Fig. 9. In the abrupt enlargement, the Mo decreases further due to the pressure decrease in the recirculation area. These decreases are shown as solid curve 2 and solid curve 3 in Fig. 9. The difference between curve 2 and curve 3 is owing to the different ratio of enlargement, which is defined as the ratio of enlargement diameter to the orifice ring diameter of the ATS valve. The larger the ratio of enlargement, the smaller the opening moment M o. Curve 2 has a small ratio of enlargement, and curve 3 has a large ratio of enlargement, so

Close Opening moment Mo

~9

b Opening angle of leaflet Fig. 8. Illustration of the open-pivot effect in ATS leaflet movement. a Mechanism of non-fully-open,b Stagnation of fully-open Fig. 9. Moments in ATS valve to influence leaflet movement, where curve 1 is for the straight conduit, curve 2 is for the small ratio of enlargement, and curve 3 is for the large ratio of enlargement

51 the decrease of M o in curve 3 is faster than in curve 2. Figure 9 explains clearly what happened in our experiment. In the straight conduit of simulator I, the net opening moment (Mo-Ma) was always greater than zero, and therefore the leaflet must be balanced by the contact forces among the leaflet and the stoppers. We call this situation "full open." In the enlargement conduit of simulator I, the ratio of enlargement was about 1.3. It was not so large that the Mo varied according to curve 2. In this case, with the existence of the additional moment M,, the opening moment Mo could be balanced at point "a," where the position was not fully open. When the open pivot was covered, which meant the Ma was missing or became much smaller, the leaflets would open fully (at point "b") to have the stoppers help them balance. In the experiment with simulator II, the ratio of enlargement was 2.0, so that the Mo decreased dramatically following curve 3. In this case, even in the absence of the additional moment M~, the opening moment M o could decrease to zero by itself at point "d," where the position was not yet fully opened. That is why the covered type II and type III could not make the ATS valve open fully in the simulator. The existence of the additional moment M~ merely led the maximal opening angle to become smaller (point "c"), as the outcomes in the experiment. The experiment using the covered type I in simulator II provided more evidence for the pivot effect. When the covered type I was employed, the inlet flow could directly rush into the lowvelocity and squeezing regions by covering the whole inlet orifice ring (Fig. 3); i.e., the pivot effect was strengthened. Therefore, the maximal opening angle further decreased (Fig. 7). open pivot in the covered type II and in the covered type III. But the experiment at least showed that it was not the central flow effect but the flow field alteration within the pivot region that resulted in the variations of the leaflet movement in the ATS covered types. As a final consequence, the central flow would undoubtedly change in the ATS covered types, since covering caused the variation in the opening angle. However, the central flow alteration is not the reason for the variation in the opening angle but the result of it.

Influence of the pivot effect on the pressure gradient The clinical investigation showed that the ATS valve produced a lower pressure gradient than the SJM valve, though the ATS valve did not open fully. 4 Our pressure gradient test conducted in the mitral position also confirmed this hydrodynamic performance in the ATS 29ram valve. Intuitively, the not fully open leaflets of the ATS valve could completely align with the divergent transvalvular flow so as to present much better hemodynamic characteristics than other valves could. However, after looking into the mechanism of the movement of the ATS valve by experiments, we found that the local flow field induced by the open pivot (the pivot effect) also contributed to the movement of the ATS valve. The pivot effect decreases the M O A and increases its SD; i.e. the pivot effect causes the leaflets to deviate from the completely flow-aligning position. Therefore, with the existence of the pivot effect, it cannot be said that ATS valve completely aligns with the transvalvular flow. The lower pressure gradient with the ATS 29ram valve occurred because the pivot effect was not so large in the large-sized valve that the leaflets could still respond well to the transvalvular flow. One can suppose that, in the case of a strong pivot effect, the ATS valve will no longer present a lower pressure gradient by not opening fully. Our other experiments (to be published) showed that this case could occur in a small-sized ATS valve. The small-sized ATS valve has the stronger pivot effect because the orifice diameter becomes small but the size of the open pivot is not reduced. In the small ATS valve, the strong pivot effect makes the leaflets deviate widely from the completely flowaligning position and consequently gives rise to the larger pressure gradient, as compared with that of the SJM valve. Here we incidentally discuss the situation of the ATS valve in the aortic position. The valves implanted in the aortic position usually are small, so the pivot effect is much stronger than that in large valves. Moreover, there is still an enlargement shape downstream of the implanted valves due to the aortic sinus. Taking an instance of the ATS 25 mm in the aortic position, the orifice diameter of the ATS 25 mm valve is 20mm, and in this case the diameter of the sinus may be around 30mm, so that the ratio of enlargement is about 1.5. Therefore, both affecting factors (enlargement downstream and the pivot effect, even much stronger) exist in the aortic position as in the mitral position. As a result, the ATS valve will not fully open in the aortic position either.

Discussion
Effect of the open pivot One may wonder about the effect of M~, because it comes from the small open pivot region and therefor should not be very large. However, the opening moment Mo is also quite small near the balance position. We think the magnitudes of M a and Mo near the balance position are comparable. Therefore the additional moment Ma is large enough to affect the balance position. Another explanation for the phenomena caused by the covered ATS valves is that covering increases the central flow velocity, which may decrease the pressure applied to the central sides of the leaflets so that the leaflets will open more. If this central flow hypothesis is correct, the covered type III (with the whole pivot region covered) might result in higher central flow velocity than the covered type lI (with only half of the pivot region covered). Then the opening angle of the covered type III should be larger than that of the covered type II. Contrary to the above derivation, however, in our experiments the covered type lI exhibited a larger opening angle than the covered type III (Fig. 7). To explain this phenomenon, we need to know more details of the flow fields around the

52

Conclusions
It is very difficult, if not impossible, to k e e p the in vitro and in vivo situations completely similar. However, the difficulty does not m e a n that similarity is no longer important. The clinical results and this research show that we should still carefully consider the influence of similarity, especially when evaluating a new design of a valve. A s to the mechanism of the m o v e m e n t of A T S valve, this research shows that: (1) T h e e n l a r g e m e n t d o w n s t r e a m of the A T S valve, which induces a divergent transvalvular flow, is the main reason that the A T S valve does not fully open. (2) The open-pivot effect, which induces an additional m o m e n t Ma tending to close the leaflets, also plays i m p o r t a n t role in the m o v e m e n t of the A T S valve. (3) Analysis of the mechanism of m o v e m e n t of the A T S valve is helpful in understanding the results of the pressure gradient test.

ment of Mechanical Engineering, Kanto Gakuin University) for his valuable comments and suggestions during the research. This investigation was supported by the following research funds: The program for promotion of fundamental studies in health science of the organization for drug ADR relief, R&D Promotion and Product Review of Japan (No.96-12), and Grant-in-aid for scientific research of Japan (No.09557112, No.09470288)

References
1. Wu ZJ, Gao BZ, Slonin JH, Huang NHC. Bileaflet mechanical heart valves at low cardiac output. ASAIO J 1996;42:747-749 2. Yoganathan AP, Corcoran WH, Harrison EC. Pressure drops across prosthetic aortic heart valves under steady and pulsatile flow - in vitro measurement. J Biomech 1979;12:153-164 3. Fujita T, Umezu M. Hydrodynamic performance of prosthetic heart valves. J Water Electrolyte Metabol 1986;6:247-254 4. Aoyagi S, Kawara T, Fukunaga S, Mizoguchi T, Nishi Y, Kawano H, Arinaga K. Cineradiographic evaluation of ATS open pivot bileaflet valves. J Heart Valve Dis 1997;6:258-263 5. Umezu M, Nuent A, Ye CX, Chang VP. Hydrodynamic characteristics of newly-developed prosthetic heart valves by the use of several types of in vitro test systems. Jpn J Artif Organs 1989;18: 719-722

Acknowledgments The tested ATS valve and SJM valve were provided by Century Medical, Tokyo and Getz Bros., Tokyo, respectively. The authors acknowledge Professor Toshinosuke Akutsu (Depart-