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(Circulation. 2002;106:711.)
© 2002 American Heart Association, Inc.
Clinical Investigation and Reports |
From Philips Medical Systems (I.S.S.), Andover, Mass, and the Departments of Surgery (J.H.G., R.C.G., B.M.J., F.W.B,. L.H.E.), Medicine (T.P., M.G.S.J.S.), and Anesthesia (I.S.S.), School of Medicine, University of Pennsylvania, Philadelphia, Pa.
Correspondence to Ivan S. Salgo, MS, MD, 500 Brookside Drive, Andover, MA 01810. E-mail ivan_salgo{at}attbi.com
| Abstract |
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Methods and Results Both numerical simulation and experimental data were used. The simulation consisted of an array of numerically generated mitral annular phantoms encompassing flat to markedly saddle-shaped annular heights. Highest peak leaflet stresses occurred for the flat annulus. As saddle height increased, peak stresses decreased. The minimum peak leaflet stress occurred at an annular height to commissural width ratio of 15% to 25%. The second phase involved data acquisition for the annulus from 3 humans by 3D echocardiography, 3 sheep by sonomicrometry array localization, 2 sheep by 3D echocardiography, and 2 baboons by 3D echocardiography. All 3 species imaged had annuli of a similar shape, with an annular height to commissural width ratio of 10% to 15%.
Conclusion The saddle shape of the mitral annulus confers a mechanical advantage to the leaflets by adding curvature. This may be valuable when leaflet curvature becomes reduced due to diminished leaflet billowing caused by annular dilatation. The fact that the saddle shape is conserved across mammalian species provides indirect evidence of the advantages it confers. This analysis of mitral annular contour may prove applicable in developing the next generation of mitral annular prostheses.
Key Words: finite element analysis echocardiography ultrasonics valves
| Introduction |
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| Methods |
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Numerical Simulation (Phase 1): Isolating the Effect of Leaflet Billowing Versus Annular Nonplanarity in Peak Stress Reduction
Two fundamental shapes (not leaflet designs) are generated: an elliptic paraboloid to model leaflet billowing with a flat annulus and a hyperbolic paraboloid to model annular nonplanarity with minimal leaflet billowing. These shapes are shown in Figure 1. The paraboloid with flat annulus (billowing leaflet model) is generated according to the following parametric formula in cylindrical coordinates: equation
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The "pure" saddle phantom (nonplanar annulus model) is generated according to the following formula: equation
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In both formulas, The length 2a represents the commissural diameter, 2b is the posterior-anterior diameter, and r is radius. Therefore, these parameters a and b control transverse annular dimension and hence flow area. The parametric equations 1 and 2 describe both an annulus and a surface. The parameter hb controls dome height (degree of bulging) for the billowing leaflet model (equation 1), whereas annular half-height is controlled by ha for the nonplanar annulus model (equation 2). To allow a comparison of theoretical results with experimental findings, 2 normalized parameters are defined. For the billowing leaflet model, normalized leaflet bulge (or billow) is defined as hb/2a. For the nonplanar annulus model, the annular height to commissural width ratio (AHCWR) is computed as ha/a. Using dimensions from published anatomic drawings, the parameter a is set at 19.4 mm and b at 15 mm.11 The values hb and 2ha, respectively, varied from 0 mm (a flat annulus and leaflets) to 38.75 mm, which corresponded to a dome height (billowing leaflet model) and AHCWR (nonplanar annulus model) of 100%. Using custom utilities and scripts written in C++ and Mathematica 4.0 (Wolfram Research), surfaces are plotted to discrete points and transferred to a commercial mesh generator and finite element solver (described below).
Numerical Simulation (Phase 2): Quantifying the Synergistic Effect of Leaflet Billowing and Annular Nonplanarity in Peak Stress Reduction in an Anatomically More Pragmatic Model
Two families of mitral phantoms are generated. Both families of leaflet design have constant flow orifice areas, but their annular height varies from 0 to 9.6875 mm or an AHCWR of 0% to 25%. The 2 families are distinct on the basis of the curvature of their leaflets: one has anterior and posterior leaflets of lesser curvature, whereas the other family has leaflets with more pronounced curvature as defined below. The mitral annular saddle is defined by the following parametric equation: equation
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Equation 3 represents an annulus without leaflets because the variable r is removed. It defines a 3D space curve (ie, one wire frame), not a surface. Figure 2A displays a typical annular curve generated by the equation. For all phantoms, the parameter a is set to 19.4 mm and b to 15 mm. Therefore, the commissural diameter is 38.75 mm. The parameter ha is varied to yield AHCWRs of 0%, 3%, 7%, 15%, 20%, and 25%. Two families of wire frames are constructed and transferred to a computer-aided design application (Superdraw and Supersurf, Algor, Inc). For each wire frame, a connecting line denoting the apposition of the anterior and posterior leaflets is interposed into the flat and saddle-shaped annuli as shown in Figure 2A. The center of this apposition line is connected to the aortic portion of the anterior annulus by either a curved or flat line in 3D space. Moreover, another line is connected to the midpoint of the posterior leaflet (centered within the potential medial scallop). For the flat family of phantoms, these are straight lines. For the leaflets with curved domes, they are circular arcs with tangential angles fixed at 35 and 70 degrees. Therefore, all leaflet phantoms have known curvature as described by computer-aided design techniques. Finally, the leaflets themselves are placed onto the phantom wire frames with nonuniform rational B-spline surfaces. These surfaces and general anatomic orientations are shown in Figure 2. There are 6 phantoms in each of the 2 families.
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Finite Element Analysis of Mechanical Stress
Given a specific fundamental shape (Phase I) or mitral phantom (Phase II), the next step in the analysis is to solve the differential equations of continuum mechanics to compute leaflet stress. A commercial finite element solver was used to compute stresses (Algor, Inc). A specific material model and property is used for all shapes. This is a linear, static, orthotropic material model chosen to simulate the effect of predominant collagen orientation within the leaflets.12,13 The major material axis is oriented with respect to the commissure-to-commissure orientation. Table 1 shows the values used for the analysis. Leaflet thickness is kept constant over the entire valve and to simulate end systole, a peak pressure of 16 kPa (120 torr) is used for all calculations. Therefore, the computed leaflet stresses are derived from data designed to simulate peak load. The leaflets are bound to the annulus and chordal attachments by fixed boundary conditions because the leaflets themselves flex and do not have joints. Moreover, no attempt is made to simulate chordal structures. The leaflet models are first refined using a mesh generator to space the finite element nodes optimally. Orthotropic plate elements in 3D are set for the phantoms. Peak leaflet stresses using von Mises maximum distortion energy criterion are then collected from the analysis.14,15
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Human Imaging Protocol
After approval from the Institutional Review Board, 3 people were scanned using 5 to 6.2 MHz multiplane transesophageal echocardiography (Omniplane II, Philips Medical Systems). Only subjects scheduled for first-time coronary revascularization and transesophageal echocardiography who gave consent were selected. The anesthetic included narcotic and inhalational agents (fentanyl 20 to 40 µg/kg and isoflurane 1% vol). All patients had normal ejection fractions and ventricular size. Data acquisition was gated to the ECG and respiration. Images were then centered about the mitral annulus and obtained every 10 degrees at end-systole and stored onto a magneto-optical disk for offline analysis. Images were gated to end-systole for all studies.
Ovine Surgical and Echocardiographic Imaging Protocol
Two Dorsett hybrid sheep (40 to 50 kg) were given sodium thiopental (7 mg/kg IV), intubated, anesthetized with isoflurane (1.5% to 2%), and ventilated with oxygen (Narkomed, North American Drager). All animals received glycopyrrolate (0.01 to 0.02 mg/kg IV), cefazolin (1 g IV) and gentamicin (80 mg IV). A thoracotomy incision was performed, and the heart was supported in a pericardial cradle. Three-dimensional echocardiographic scanning was performed at the cardiac apex, and 3D data were acquired every 5 degrees using a handheld 5 MHz rotational probe (Transthoracic Omniplane, Philips Medical Systems) and stored onto a magneto-optical disk. Images were gated to end-systole for all studies. Sheep were treated in compliance with NIH publication No. 85-23 as revised in 1985.
Sonomicrometry Array Localization
Three separate sheep underwent general anesthesia as described above and were placed on cardiopulmonary bypass. Through a left atriotomy, 12 sonomicrometry transducers were placed equidistant around the annulus. The animals were weaned from bypass, the incision was closed, and the animals were allowed to recover. Seven days later, intratransducer distance measurements were taken every 5 ms throughout the cardiac cycle. The 3D coordinates of each transducer were then derived from the distance data using a multidimensional scaling technique.
Baboon Echocardiographic Imaging Protocol
Two adult baboons (13 and 18 kg) were given ketamine (10 mg/kg IV), intubated, anesthetized with isoflurane (1.5% to 2%), and ventilated with oxygen (Narkomed, North American Drager). All animals received atropine (0.01 to 0.02 mg/kg IV), cefazolin (1 g IV), and gentamicin (80 mg IV). Baboons were treated in compliance with NIH publication No. 85-23 as revised in 1985.
The baboons were imaged from the chest wall by 3D multiplane echocardiography. Data were acquired from 2 baboons every 5 degrees using a handheld rotational probe (Transthoracic Omniplane) and stored onto a magneto-optical disk for offline analysis. Images were gated to end-systole for all studies.
3D Echo Image Analysis
Using custom image manipulation software written for this work, the mitral annulus was identified offline from the 3D echocardiographic studies. Annular points (2 for each corresponding angle from the representative image) were transformed in 3D space. These points were calibrated to the depth setting of the imaging probe, and the aspect ratio was accounted for by a constant in the software. The mitral annulus was fit to a plane using the following formula: equation
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Its orientation minimizes the least squares error. The xy plane is oriented orthogonal to flow. Using a quaternion geometric transformation, the maximum and minimum annular heights (z axis) are compared with the maximum cross-sectional diameter. Data acquired from echocardiography or sonomicrometry are interpolated and analyzed using a discrete Fourier transform with a Gaussian convolution kernel. This is used for both visualization and quantitation. Figure 3 demonstrates one of the echocardiographic reconstructions done on a human subject. The AHCWR was computed for the 3 humans, 5 sheep, and 2 baboons.
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| Results |
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Phase 2: Finite Element Analysis of the Synergistic Effect of Leaflet Bulging and Annular Nonplanarity in Peak Stress Reduction
Figure 5 shows peak stresses for the mitral phantoms. Because the center of the leaflet is supported by chordal boundaries, peak leaflet stress is lower than that of the flat annulus presented in the prior section: 110 MPa (Figure 5A) versus 336 MPa (Figure 4), respectively. Figure 5 shows that for both families of mitral phantoms (flattened and curved leaflets), introduction of the saddle-shaped annulus reduces peak leaflet stress. Increasing AHCWR to 20% with flat leaflets reduces peak leaflet stress 3-fold from 110 MPa to <40 MPa. The addition of curved leaflets (bulging) to the 20% AHCWR model decreases the total leaflet stress another 5-fold to 7 MPa. Figure 6 shows stress distribution for a valve with an AHCWR of 20%. Figures 5 and 6 illustrate the synergistic nature of combined leaflet bulging and the annular saddle shape on peak mitral valve leaflet stress. With or without leaflet billowing, the stress reduction associated with annular saddle shape reaches a maximum effect at an AHCWR value between 15% and 20% (Figure 5).
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Experimental Determination of Mitral Annular Height
Table 2 displays the annular height ratios found in 3 species. All have a saddle-shaped mitral annuli. Three-dimensional echocardiographic determinations of the 3 human patients yield an AHCWR of 14% to 16%. The 2 sheep studied by echocardiography have AHCWRs of 12% and 17%. Sonomicrometry results yield AHCWRs of 13%, 19%, and 7% for different sheep. Finally, the 2 baboons have AHCWRs of 14% and 17%.
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| Discussion |
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Finite element analysis is a tool used to solve the differential equations of mechanical stress. This computer-based technique is used so solve problems of arbitrarily defined geometry according to a specific design because only the most simple of shapes can be solved analytically by hand. For example, linear static finite element computer modeling of the mitral valve has been used to examine general mechanical properties. For static linear models, computation of stress (although not strain) yields the same final result independent of material modulus.
The simulation for phase II was designed to extend the hypothesis to a more realistic geometric shape, one that specifically uses chordal support. An early study using a Laplaces law model indicated that curvature of the leaflets is beneficial. For the current study, the leaflets were designed to satisfy the following design constraints. First, symmetry of leaflets was preserved with reference to the commissures. This assumes that peak stresses of equal magnitude occur bilaterally. Second, the posterior leaflets were not scalloped (ie, sharply marginalized) to study the effect of the annulus on leaflets that may lose curvature in vivo. The design, although more realistic than the first part, is intentionally kept constrained to understand effects of stress by controlling perturbations of leaflet design. Under these conditions, the data for the mitral phantom simulation demonstrate that (1) leaflet curvature is a major determinant of leaflet stress and (2) the saddle shape of the annulus contributes to reductions in leaflet stress by providing another mechanism of leaflet curvature in addition to leaflet billowing.
Two different imaging techniques that were performed to verify these predictions show that the saddle shape of the mitral annulus is preserved across 3 mammalian species. All subjects had an AHCWR of
15% (with one outlier), and none of the subject hearts was dilated. The finite element analyses consistently demonstrate that leaflet stress reductions occur in the range of AHCWRs of 15% to 20%. These data strongly suggest that nature conserves the saddle-shaped annulus for a mechanical benefit.
Analysis of actual leaflet shapes by imaging studies was not a goal of this study because of errors created by spatiotemporal shifting in gated 3D echocardiographic techniques.2023 Medical imaging techniques are only beginning to acquire data (of the fidelity needed for this type of analysis) of structures that move as quickly as leaflets. Because the annulus has much slower velocity components than the leaflets during the cardiac cycle, gated 3D echocardiography was used to image the annulus. However, optimal annulus filtering techniques in the Fourier (spectral) domain are not well established. Excessive low pass spatial filtering yields an annulus that is flatter than actual. Without spatial filtering, all AHCWRs would be higher, and thus our data report the lower bounds. This may explain why our experimental results tended toward the low end (15% AHCWR) of the predicted stress-minimizing AHCWR range of 15% to 20%. As real time magnetic resonance and matrix array 3D echocardiographic techniques evolve, imaging of the entire leaflets themselves with subsequent finite element analysis will become feasible. These results, taken in conjunction with the theoretical calculations presented above, provide compelling evidence that the saddle shape of the mitral annulus significantly reduces leaflet stress at AHCRW ratios between 15% to 20%.
The analysis presented in this study provides insight into potential methods for improving current mitral valve repair techniques. Over the past 20 years, Carpentier has pioneered and standardized surgical techniques that allow reliable repair of valves with leaflet, chordal, and annular deformities.24 The widespread use of these techniques has produced notable results at centers all over the world. Although the durability of these repairs has been relatively impressive, there is a long-term failure rate of between 5% and 12% (return of significant mitral regurgitation) at 10 years, depending on the type of initial leaflet or annular pathology.2527 Twenty year recurrence rates for repaired rheumatic valves may be as high as 50%.28 In most cases, these long-term failures are the result of disruption at leaflet, chordal, or annular suture lines, suggesting mechanical stress as an etiological factor.29
Most surgeons with experience in mitral valve repair agree that restoration of normal annular geometry with ring annuloplasty is an essential component to all mitral valve repairs. In fact, it has been shown that leaflet repairs without ring annuloplasty are less durable than those that include it.26 All currently available annuloplasty rings are flat. When implanted, these devices only restore the annulus to a more normal size in 2 dimensions. The height of the annulus is totally flattened by these devices, potentially placing undue stress and subsequent strain on the leaflet and chordal suture lines of the repair by diminishing leaflet curvature. Moreover, using larger saddle-shaped annular prostheses instead of their flat counterparts could allow increases in flow area while keeping peak leaflet stresses reduced. With this understanding, it seems reasonable to hypothesize that a saddle-shaped annuloplasty ring may increase mitral valve repair durability by reducing leaflet and chordal strain.
| Acknowledgments |
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| Footnotes |
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Received January 10, 2002; revision received May 23, 2002; accepted May 24, 2002.
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T. A. Timek, J. R. Glasson, D. T. Lai, D. Liang, G. T. Daughters, N. B. Ingels Jr, and D. C. Miller Annular Height-to-Commissural Width Ratio of Annulolasty Rings In Vivo Circulation, August 30, 2005; 112(9_suppl): I-423 - I-428. [Abstract] [Full Text] [PDF] |
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N. Watanabe, Y. Ogasawara, Y. Yamaura, N. Wada, T. Kawamoto, E. Toyota, T. Akasaka, and K. Yoshida Mitral Annulus Flattens in Ischemic Mitral Regurgitation: Geometric Differences Between Inferior and Anterior Myocardial Infarction: A Real-Time 3-Dimensional Echocardiographic Study Circulation, August 30, 2005; 112(9_suppl): I-458 - I-462. [Abstract] [Full Text] [PDF] |
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N. Watanabe, Y. Ogasawara, Y. Yamaura, T. Kawamoto, E. Toyota, T. Akasaka, and K. Yoshida Quantitation of mitral valve tenting in ischemic mitral regurgitation by transthoracic real-time three-dimensional echocardiography J. Am. Coll. Cardiol., March 1, 2005; 45(5): 763 - 769. [Abstract] [Full Text] [PDF] |
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E. Villa, P. Fundaro, A. Moneta, and F. Donatelli Chronic Ischemic Mitral Regurgitation: Toward a Solution or Still an Enigma? Ann. Thorac. Surg., February 1, 2005; 79(2): 752 - 752. [Full Text] [PDF] |
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C. Carlhall, L. Wigstrom, E. Heiberg, M. Karlsson, A. F. Bolger, and E. Nylander Contribution of mitral annular excursion and shape dynamics to total left ventricular volume change Am J Physiol Heart Circ Physiol, October 1, 2004; 287(4): H1836 - H1841. [Abstract] [Full Text] [PDF] |
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T. A. Timek, D. T. Lai, D. Liang, F. Tibayan, F. Langer, F. Rodriguez, G. T. Daughters, N. B. Ingels Jr, and D. C. Miller Effects of Paracommissural Septal-Lateral Annular Cinching on Acute Ischemic Mitral Regurgitation Circulation, September 14, 2004; 110(11_suppl_1): II-79 - II-84. [Abstract] [Full Text] [PDF] |
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M. H. Yacoub and L. H. Cohn Novel Approaches to Cardiac Valve Repair: From Structure to Function: Part I Circulation, March 2, 2004; 109(8): 942 - 950. [Full Text] [PDF] |
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J. H. Gorman III, B. M. Jackson, S. L. Moainie, Y. Enomoto, and R. C. Gorman Influence of inotropy and chronotropy on the mitral valve sphincter mechanism Ann. Thorac. Surg., March 1, 2004; 77(3): 852 - 857. [Abstract] [Full Text] [PDF] |
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F. A. Tibayan, F. Rodriguez, F. Langer, M. K. Zasio, L. Bailey, D. Liang, G. T. Daughters, N. B. Ingels Jr, and D. C. Miller Does septal-lateral annular cinching work for chronic ischemic mitral regurgitation? J. Thorac. Cardiovasc. Surg., March 1, 2004; 127(3): 654 - 663. [Abstract] [Full Text] [PDF] |
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J. H. Gorman III and R. C. Gorman Invited commentary Ann. Thorac. Surg., February 1, 2004; 77(2): 522 - 522. [Full Text] [PDF] |
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J. H. Gorman III, B. M. Jackson, Y. Enomoto, and R. C. Gorman The effect of regional ischemia on mitral valve annular saddle shape Ann. Thorac. Surg., February 1, 2004; 77(2): 544 - 548. [Abstract] [Full Text] [PDF] |
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F. A. Tibayan, F. Rodriguez, F. Langer, M. K. Zasio, L. Bailey, D. Liang, G. T. Daughters, N. B. Ingels Jr, and D. C. Miller Annular remodeling in chronic ischemic mitral regurgitation: ring selection implications Ann. Thorac. Surg., November 1, 2003; 76(5): 1549 - 1555. [Abstract] [Full Text] [PDF] |
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F. A. Tibayan, F. Rodriguez, D. Liang, G. T. Daughters, N. B. Ingels Jr, and D. C. Miller Paneth Suture Annuloplasty Abolishes Acute Ischemic Mitral Regurgitation but Preserves Annular and Leaflet Dynamics Circulation, September 9, 2003; 108(90101): II-128 - 133. [Abstract] [Full Text] [PDF] |
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R. C. Gorman, J. H. Gorman III, and L. H. Edmunds Jr. Ischemic Mitral Regurgitation Card. Surg. Adult, January 1, 2003; 2(2003): 751 - 769. [Full Text] |
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