Turbulence downstream of subcoronary stentless and stented aortic valves

Regions of turbulence downstream of bioprosthetic heart valves may cause damage to blood components, vessel wall as well as to aortic valve leaflets. Stentless aortic heart valves are known to posses several hemodynamic benefits such as larger effective orifice areas, lower aortic transvalvular pressure difference and faster left ventricular mass regression compared with their stented counterpart. Whether this is reflected by diminished turbulence formation, remains to be shown. We implanted either stented pericardial valve prostheses (Mitroflow), stentless valve prostheses (Solo or Toronto SPV) in pigs or they preserved their native valves. Following surgery, blood velocity was measured in the cross sectional area downstream of the valves using 10MHz ultrasonic probes connected to a dedicated pulsed Doppler equipment. As a measure of turbulence, Reynolds normal stress (RNS) was calculated at two different blood pressures (baseline and 50% increase). We found no difference in maximum RNS measurements between any of the investigated valve groups. The native valve had significantly lower mean RNS values than the Mitroflow (p=0.004), Toronto SPV (p=0.008) and Solo valve (p=0.02). There were no statistically significant differences between the artificial valve groups (p=0.3). The mean RNS was significantly larger when increasing blood pressure (p=0.0006). We, thus, found no advantages for the stentless aortic valves compared with stented prosthesis in terms of lower maximum or mean RNS values. Native valves have a significantly lower mean RNS value than all investigated bioprostheses.     

A three-dimensional mechanical analysis of a stentless fibre-reinforced aortic valve prosthesis

Failure of bioprosthetic and synthetic three-leaflet valves has been shown to occur as a consequence of high tensile and bending stresses, acting on the leaflets during opening and closing. Moreover, in the stented prostheses, whether synthetic or biological, the absence of contraction of the aortic base, due to the rigid stent, causes the leaflets to be subjected to an unphysiological degree of flexure, which is related to calcification. It is shown that the absence of the stent, which gives a flexible aortic base and leaflet attachment, and leaflet fibre-reinforcement result in reduced stresses in the weaker parts of the leaflets in their closed configuration. It is postulated that this leads to a decrease of tears and perforations, which may result in a improved long-term behaviour. The effect of a flexible leaflet attachment and aortic base of a synthetic valve is investigated with a finite element model. Different fibre-reinforced structures are analysed with respect to the stresses that are likely to contribute to the failure of fibre-reinforced prostheses and compared with the results obtained for a stented prosthesis. Results show that for the stentless models a reduction of stresses up to 75% is obtained with respect to stented models with the same type of reinforcement.     

A computational fluid-structure interaction analysis of a fiber-reinforced stentless aortic valve

The importance of the aortic root compliance in the aortic valve performance has most frequently been ignored in computational valve modeling, although it has a significant contribution to the functionality of the valve. Aortic root aneurysm or (calcific) stiffening severely affects the aortic valve behavior and, consequently, the cardiovascular regulation. The compromised mechanical and hemodynamical performance of the valve are difficult to study both 'in vivo' and 'in vitro'. Computational analysis of the valve enables a study on system responses that are difficult to obtain otherwise. In this paper a numerical model of a fiber-reinforced stentless aortic valve is presented. In the computational evaluation of its clinical functioning the interaction of the valve with the blood is essential. Hence, the blood-tissue interaction is incorporated in the model using a combined fictitious domain/arbitrary Lagrange-Euler formulation, which is integrated within the Galerkin finite element method. The model can serve as a diagnostic tool for clinical purposes and as a design tool for improving existing valve prostheses or developing new concepts. Structural mechanical and fluid dynamical aspects are analyzed during the systolic course of the cardiac cycle. Results show that aortic root compliance largely influences the valve opening and closing configurations. Stresses in the delicate parts of the leaflets are substantially reduced if fiber-reinforcement is applied and the aortic root is able to expand.     

Ventriculo-aortic junction in human root. A geometric approach

With advances in tissue engineering and improvement of surgical techniques, stentless biological valves and valve-sparing procedures have become alternatives to traditional aortic valve replacement with stented bioprostheses or mechanical valves. New surgical techniques preserve the advantages of native valves but require better understanding of the anatomical structure of the aortic root. Silicone rubber was injected in fresh aortic roots of nine human cadavers under the physiological closing pressure of 80 mmHg. The casts reproduced every detail of the aortic root anatomy and were used to digitize 27 leaflet attachment lines (LALs) of the aortic valves. LALs were normalized and described with a mathematical model. LALs were found to follow a pattern with the right coronary being the largest followed by the non-coronary and then the left coronary. During diastole, the aortic valve LAL can be described by an intersection between a created tube and an extruded parabolic surface. This geometrical definition of the LAL during end diastole gives a better understanding of the aortic root anatomy and could be useful for heart valve design and improvement of aortic valve reconstruction technique.     

Reduced Leaflet Stress in the Stentless Quadrileaflet Mitral Valve: A Finite Element Model

Background

Failure of bioprosthetics is usually caused by calcification of the leaflets as a consequence of high tensile stresses. The stentless valve resembles native mitral valve anatomy, has a flexible leaflet attachment and a suspension at the papillary muscles, and preserves annuloventricular continuity. In this study, the effects of the stentless valve design on leaflet stress were investigated with a finite element model.

Methods

Finite element models of the stentless quadrileaflet mitral valve were created in the close and open configurations. The geometry of the stented trileaflet mitral valve was also analyzed for comparative purposes. Under the designated pressures, the regional stresses were evaluated, and the distributions of stresses were assessed.

Results

Regardless of whether the valve is in the open or close configuration, the maximum first principal stress was significantly lower in the stentless valve than in the stented valve. For the stentless valves, limited stress concentration was discretely distributed in the papillary flaps under both close and open conditions. In contrast, in the stented valve, increased stress concentration was evident at the central belly under the open condition and at the commissural attachment under close condition. In either configuration, the maximum second principal stress was markedly lower in the stentless valve than in the stented valve.

Conclusions

The stentless valve was associated with a significant reduction in leaflet stress and a more homogeneous stress distribution compared to the stented valve. These findings are consistent with recent reports of the clinical effectiveness of the stentless quadrileaflet mitral valve.     

A synthetic fiber-reinforced stentless heart valve

There is strong evidence that failure of bioprosthetic and synthetic valves occurs as a consequence of high tensile and bending stresses, acting on the leaflets during opening and closing. In stented prostheses, whether synthetic or biological, the absence of contraction of the aortic base causes the leaflets to be subjected to an unphysiological degree of flexure, which is also related to calcification. However, a stentless synthetic valve, which has a flexible aorta base, can be a good alternative for stented synthetic valves. Moreover, fiber-reinforcement is assumed to lead to a decrease of tears and perforation as a result of reduced stresses in the weaker parts of the leaflets in their closed configuration. The manufacturing method for a stentless, fiber-reinforced, synthetic valve is presented. Prototypes are tested in a pulse duplicator system. The results show that the mean systolic pressure difference is very low, while the high regurgitation (up to 26%) is probably caused by a too small coaptation area of the leaflets.     

A three-dimensional computational analysis of fluid-structure interaction in the aortic valve

Numerical analysis of the aortic valve has mainly been focused on the closing behaviour during the diastolic phase rather than the kinematic opening and closing behaviour during the systolic phase of the cardiac cycle. Moreover, the fluid-structure interaction in the aortic valve system is most frequently ignored in numerical modelling. The effect of this interaction on the valve's behaviour during systolic functioning is investigated. The large differences in material properties of fluid and structure and the finite motion of the leaflets complicate blood-valve interaction modelling. This has impeded numerical analyses of valves operating under physiological conditions. A numerical method, known as the Lagrange multiplier based fictitious domain method, is used to describe the large leaflet motion within the computational fluid domain. This method is applied to a three-dimensional finite element model of a stented aortic valve. The model provides both the mechanical behaviour of the valve and the blood flow through it. Results show that during systole the leaflets of the stented valve appear to be moving with the fluid in an essentially kinematical process governed by the fluid motion.     

Stentless Versus Stented Bioprosthetic Aortic Valves: A Consensus Statement of the International Society of Minimally Invasive Cardiothoracic Surgery (ISMICS) 2008

OBJECTIVE:: The purpose of this consensus conference was to determine whether stentless bioprosthetic valves improve clinical and resource outcomes compared with stented valves in patients undergoing aortic valve replacement, and to outline evidence-based recommendations for the use of stentless and stented bioprosthetic valves in adult aortic valve replacement. METHODS:: Before the consensus conference, the best available evidence was reviewed in that systematic reviews, randomized trials, and nonrandomized trials were considered in descending order of validity and importance. At the consensus conference, evidence-based statements were created, and consensus processes were used to determine the ensuing recommendations. The American Heart Association/American College of Cardiology system was used to label the level of evidence and class of recommendation. RESULTS AND RECOMMENDATIONS:: Seventeen randomized studies published in 23 articles involving 1317 patients, and 14 nonrandomized trial published in 18 articles involving 2485 patients were included in the meta-analysis and consensus conference. All randomized trials inserted the stentless bioprosthetic valves in the subcoronary configuration. The consensus panel agreed upon the following statements and recommendations in patients undergoing aortic valve replacement:Because there were no randomized control trial comparing subcoronary stentless prosthetic valve and root replacement, the following recommendations are derived from expert opinion:     

Experimental technique of measuring dynamic fluid shear stress on the aortic surface of the aortic valve leaflet

Aortic valve (AV) calcification is a highly prevalent disease with serious impact on mortality and morbidity. The exact cause and mechanism of the progression of AV calcification is unknown, although mechanical forces have been known to play a role. It is thus important to characterize the mechanical environment of the AV. In the current study, we establish a methodology of measuring shear stresses experienced by the aortic surface of the AV leaflets using an in vitro valve model and adapting the laser Doppler velocimetry (LDV) technique. The valve model was constructed from a fresh porcine aortic valve, which was trimmed and sutured onto a plastic stented ring, and inserted into an idealized three-lobed sinus acrylic chamber. Valve leaflet location was measured by obtaining the location of highest back-scattered LDV laser light intensity. The technique of performing LDV measurements near to biological surfaces as well as the leaflet locating technique was first validated in two phantom flow systems: (1) steady flow within a straight tube with AV leaflet adhered to the wall, and (2) steady flow within the actual valve model. Dynamic shear stresses were then obtained by applying the techniques on the valve model in a physiologic pulsatile flow loop. Results show that aortic surface shear stresses are low during early systole (<5 dyn/cm2) but elevated to its peak during mid to late systole at about 18-20 dyn/cm2. Low magnitude shear stress (<5 dyn/cm2) was observed during early diastole and dissipated to zero over the diastolic duration. Systolic shear stress was observed to elevate only with the formation of sinus vortex flow. The presented technique can also be used on other in vitro valve models such as congenitally geometrically malformed valves, or to investigate effects of hemodynamics on valve shear stress. Shear stress data can be used for further experiments investigating effects of fluid shear stress on valve biology, for conditioning tissue engineered AV, and to validate numerical simulations.     

Patient-specific simulation of a stentless aortic valve implant: the impact of fibres on leaflet performance

In some cases of aortic valve leaflet disease, the implant of a stentless biological prosthesis represents an excellent option for aortic valve replacement (AVR). In particular, if compared with the implant of mechanical valves, it provides a more physiological haemodynamic performance and a reduced thrombogeneticity, avoiding the use of anticoagulants. The clinical outcomes of AVR are strongly dependent on an appropriate choice of both prosthesis size and replacement technique, which is, at present, strictly related to surgeon's experience and skill. This represents the motivation for patient-specific finite element analysis able to virtually reproduce stentless valve implantation. With the aim of performing reliable patient-specific simulations, we remark that, on the one hand, it is not well established in the literature whether bioprosthetic leaflet tissue is isotropic or anisotropic; on the other hand, it is of fundamental importance to incorporate an accurate material model to realistically predict post-operative performance. Within this framework, using a novel computational methodology to simulate stentless valve implantation, we test the impact of using different material models on both the stress pattern and post-operative coaptation parameters (i.e. coaptation area, length and height). As expected, the simulation results suggest that the material properties of the valve leaflets affect significantly the post-operative prosthesis performance.     

Improving the Efficiency of Abdominal Aortic Aneurysm Wall Stress Computations

An abdominal aortic aneurysm is a pathological dilation of the abdominal aorta, which carries a high mortality rate if ruptured. The most commonly used surrogate marker of rupture risk is the maximal transverse diameter of the aneurysm. More recent studies suggest that wall stress from models of patient-specific aneurysm geometries extracted, for instance, from computed tomography images may be a more accurate predictor of rupture risk and an important factor in AAA size progression. However, quantification of wall stress is typically computationally intensive and time-consuming, mainly due to the nonlinear mechanical behavior of the abdominal aortic aneurysm walls. These difficulties have limited the potential of computational models in clinical practice. To facilitate computation of wall stresses, we propose to use a linear approach that ensures equilibrium of wall stresses in the aneurysms. This proposed linear model approach is easy to implement and eliminates the burden of nonlinear computations. To assess the accuracy of our proposed approach to compute wall stresses, results from idealized and patient-specific model simulations were compared to those obtained using conventional approaches and to those of a hypothetical, reference abdominal aortic aneurysm model. For the reference model, wall mechanical properties and the initial unloaded and unstressed configuration were assumed to be known, and the resulting wall stresses were used as reference for comparison. Our proposed linear approach accurately approximates wall stresses for varying model geometries and wall material properties. Our findings suggest that the proposed linear approach could be used as an effective, efficient, easy-to-use clinical tool to estimate patient-specific wall stresses.     

Stentless Versus Stented Bioprosthetic Aortic Valves: A Systematic Review and Meta-Analysis of Controlled Trials

OBJECTIVE:: This meta-analysis sought to determine whether stentless bioprosthetic valves improve clinical and resource outcomes compared with stented valves in patients undergoing aortic valve replacement. METHODS:: A comprehensive search was undertaken to identify all randomized and nonrandomized controlled trials comparing stentless to stented bioprosthetic valves in patients undergoing aortic valve replacement available up to March 2008. The primary outcomes were clinical and resource outcomes in randomized controlled trial (RCT). Secondary outcomes clinical and resource outcomes in nonrandomized controlled trial (non-RCT). Odds ratios (OR), weighted mean differences (WMD), or standardized mean differences and their 95% confidence intervals (CI) were analyzed as appropriate. RESULTS:: Seventeen RCTs published in 23 articles involving 1317 patients, and 14 non-RCTs published in 18 articles involving 2485 patients were included in the meta-analysis. For the primary analysis of randomized trials, mortality for stentless versus stented valve groups did not differ at 30 days (OR 1.36, 95% CI 0.68-2.72), 1 year (OR 1.01, 95% CI 0.55-1.85), or 2 to 10 years follow-up (OR 0.82, 95% CI 0.50-1.33). Aggregate event rates for all-cause mortality at 30 days were 3.7% versus 2.9%, at 1 year were 5.5% versus 5.9% and at 2 to 10 years were 17% versus 19% for stentless versus stented valve groups, respectively. Stroke or neurologic complications did not differ between stentless (3.6%) and stented (4.0%) valve groups. Risk of prosthesis-patient mismatch was numerically lower in the stentless group (11.0% vs. 31.3%, OR 0.30, 95% CI 0.05-1.66), but this parameter was reported in few trials and did not reach statistical significance. Effective orifice area index was significantly greater for stentless aortic valve compared with stented valves at 30 days (WMD 0.12 cm/m), at 2 to 6 months (WMD 0.15 cm/m), and at 1 year (WMD 0.26 cm/m). Mean gradient at 1 month was significantly lower in the stentless valve group (WMD -6 mm Hg), at 2 to 6 month follow-up (WMD -4 mm Hg,), at 1 year follow-up (WMD -3 mm Hg) and up to 3 year follow-up (WMD -3 mm Hg) compared with the stented valve group. Although the left ventricular mass index was generally lower in the stentless group versus the stented valve group, the aggregate estimates of mean difference did not reach significance during any time period of follow-up (1 month, 2-6 months, 1 year, and 8 years). CONCLUSIONS:: Evidence from randomized trials shows that subcoronary stentless aortic valves improve hemodynamic parameters of effective orifice area index, mean gradient, and peak gradient over the short and long term. These improvements have not led to proven impact on patient morbidity, mortality, and resource-related outcomes; however, few trials reported on clinical outcomes beyond 1 year and definitive conclusions are not possible until sufficient evidence addresses longer-term effects.     

Fluid-structure interaction of deformable aortic prostheses with a bileaflet mechanical valve

Two different aortic prostheses can be used for performing the Bentall procedure: a standard straight graft and the Valsalva graft that better reproduces the aortic root anatomy. The aim of the present work is to study the effect of the graft geometry on the blood flow when a bileaflet mechanical heart valve is used, as well as to evaluate the stress concentration near the suture line where the coronary arteries are connected to graft. An accurate three-dimensional numerical method is proposed, based on the immersed boundary technique. The method accounts for the interactions between the flow and the motion of the rigid leaflets and of the deformable aortic root, under physiological pulsatile conditions. The results show that the graft geometry only slightly influences the leaflets dynamics, while using the Valsalva graft the stress level near the coronary-root anastomoses is about half that obtained using the standard straight graft.     

Patient-specific modeling of biomechanical interaction in transcatheter aortic valve deployment

The objective of this study was to develop a patient-specific computational model to quantify the biomechanical interaction between the transcatheter aortic valve (TAV) stent and the stenotic aortic valve during TAV intervention. Finite element models of a patient-specific stenotic aortic valve were reconstructed from multi-slice computed tomography (MSCT) scans, and TAV stent deployment into the aortic root was simulated. Three initial aortic root geometries of this patient were analyzed: (a) aortic root geometry directly reconstructed from MSCT scans, (b) aortic root geometry at the rapid right ventricle pacing phase, and (c) aortic root geometry with surrounding myocardial tissue. The simulation results demonstrated that stress, strain, and contact forces of the aortic root model directly reconstructed from MSCT scans were significantly lower than those of the model at the rapid ventricular pacing phase. Moreover, the presence of surrounding myocardium slightly increased the mechanical responses. Peak stresses and strains were observed around the calcified regions in the leaflets, suggesting the calcified leaflets helped secure the stent in position. In addition, these elevated stresses induced during TAV stent deployment indicated a possibility of tissue tearing and breakdown of calcium deposits, which might lead to an increased risk of stroke. The potential of paravalvular leak and occlusion of coronary ostia can be evaluated from simulated post-deployment aortic root geometries. The developed computational models could be a valuable tool for pre-operative planning of TAV intervention and facilitate next generation TAV device design.     

Giant pseudoaneurysm after aortic root replacement

A 22-year-old woman was born with a bicuspid aortic valve. Initially she underwent a valvulotomy, followed by a Ross procedure nine years later. Because of dilation of the autograft, a root replacement was performed with a Freestyle stentless bioprosthesis.     

Biomechanical characterization of the native porcine aortic root

A thorough understanding of the well-functioning, native aortic root is pivotal in an era, where valve sparing surgical techniques are developed and used with increasing frequency. The objective of this study was to characterize the local structural stiffness of the native aortic root, to create a baseline for understanding how different surgical interventions affect the dynamics of the aortic root. In this acute porcine study (N = 10), two dedicated force transducers were implanted to quantify the forces acting on both the annular plane and on the sinotubular junction (STJ). To assess the changes in geometry, eleven sonomicrometry crystals were implanted within the aortic root. The combination of force and length measurements yields the radial structural stiffness for each segment of the aortic root.The least compliant segment at the annular plane was the right-left interleaflet triangle with a stiffness modulus of 1.1 N mm⁻¹ (SD0.4). At the sinotubular junction the same segment (right-left) was most compliant, compared with the two other segments, however not statistically significant different.The elastic energy storage was derived from the aortic root pressure volume relationship; the mean elastic energy storage was 826 µJ (SD529). In conclusion, the aortic root has been characterized in terms of both segmental forces, segmental change in length and elastic energy storage. This study is the first to assess the radial structural stiffness of different segments of the aortic root. The presented data is reference for further studies regarding the impact of surgical interventions on the aortic root.     

Simulation of transcatheter aortic valve implantation: a patient-specific finite element approach

Until recently, heart valve failure has been treated adopting open-heart surgical techniques and cardiopulmonary bypass. However, over the last decade, minimally invasive procedures have been developed to avoid high risks associated with conventional open-chest valve replacement techniques. Such a recent and innovative procedure represents an optimal field for conducting investigations through virtual computer-based simulations: in fact, nowadays, computational engineering is widely used to unravel many problems in the biomedical field of cardiovascular mechanics and specifically, minimally invasive procedures. In this study, we investigate a balloon-expandable valve and we propose a novel simulation strategy to reproduce its implantation using computational tools. Focusing on the Edwards SAPIEN valve in particular, we simulate both stent crimping and deployment through balloon inflation. The developed procedure enabled us to obtain the entire prosthetic device virtually implanted in a patient-specific aortic root created by processing medical images; hence, it allows evaluation of postoperative prosthesis performance depending on different factors (e.g. device size and prosthesis placement site). Notably, prosthesis positioning in two different cases (distal and proximal) has been examined in terms of coaptation area, average stress on valve leaflets as well as impact on the aortic root wall. The coaptation area is significantly affected by the positioning strategy ( ? 24%, moving from the proximal to distal) as well as the stress distribution on both the leaflets (+13.5%, from proximal to distal) and the aortic wall ( ? 22%, from proximal to distal). No remarkable variations of the stress state on the stent struts have been obtained in the two investigated cases.     

Stress related collagen ultrastructure in human aortic valves--implications for tissue engineering

Understanding the response of tissue structures to mechanical stress is crucial for optimization of mechanical conditioning protocols in the field of heart valve tissue engineering. In heart valve tissue, it is unclear to what extent mechanical loading affects the collagen fibril morphology. To determine if local stress affects the collagen fibril morphology, in terms of fibril diameter, its distribution, and the fibril density, this was investigated in adult native human aortic valve leaflets. Transmission electron microscopy images of collagen fibrils were analyzed at three locations: the commissures, the belly, and the fixed edge of the leaflets. Subsequently, the mechanical behavior of human aortic valves was used in a computational model to predict the stress distribution in the valve leaflet during the diastolic phase of the cardiac cycle. The local stresses at the three locations were related to the collagen fibril morphology. The fibril diameter and density varied significantly between the measured locations, and appeared inversely related. The average fibril diameter increased from the fixed edge, to the belly, and to the commissures of the leaflets, while fibril density decreased. Interestingly, these differences corresponded well with the level of stress at the locations. The presented data showed that large tissue stress is associated with greater average fibril diameter, lower fibril density, and wider fibril size distribution compared with low stress locations in the leaflets. The findings here provide insight in the effect of mechanical loading on the collagen ultrastructure, and are valuable to improve conditioning protocols for tissue engineering.     

Stentless aortic valve implantation through an upper manubrium-limited V-type ministernotomy

In this piece of work, we attempt to highlight our approach and early experience with minimally invasive aortic valve replacement with aortic Freedom Solo stentless bioprosthesis performed through an upper manubrium-limited ministernotomy in the second intercostal space. The novel suturing technique is required for stentless aortic bioprosthesis implantation, and this, in its turn, will predetermine and influence the surgeon's choice for operative access. In our department, the feasibility of the approach was first assessed; aortic valve was replaced by stentless bioprosthesis in a total of 23 patients (mean age 57 ± 12 years). In all cases, a cardiopulmonary bypass was established by a central ascending aorta cannulation and peripheral percutaneous venous cannula insertion. This approach was found to be technically reproducible and safe. The surgical technique used is described in this article.