Left atrial appendage inversion: First computational study to shed light on the phenomenon.

Inversion of the left atrial appendage is a rare phenomenon, which may occur during the de-airing maneuvers associated to routinely performed surgery procedures, such as cardiopulmonary bypass or left ventricular assist device implantation. In this case, the body of the inverted appendage can obstruct the mitral valve leading to severe complications. The mechanisms are still poorly known, and more specific studies are needed to better understand its causes and identify mitigating strategies. The current study attempts to gain a better comprehension of the conditions and the factors favourable to left atrial appendage inversion. Four patient specific appendage morphologies, obtained from computerised tomography and representative of the main typologies commonly used for the appendage classification (chicken wing, cactus, cauliflower, and windsock), were used for the study. The numerical models were subjected to the same loading pattern, made of subsequent different pressure curves. Results show that the morphologies invert and recover their original anatomical configuration at different pressure loads, indicating that their tendency to invert is associated to their specific morphological features. Moreover, the analysis highlights that, although restoring the physiological left atrium pressure is not sufficient to induce appendage recovery, pressures well below the ventricular ones can induce the return to the natural configuration. All models recovered the anatomical configuration at pressures well below the ventricular pressure (about 100 mmHg), suggesting that basic trans-catheter maneuvers, e.g. producing temporary mitral regurgitation, could be attempted to correct the appendage configuration, prior to opt for more invasive surgical approaches.

Fluid-structure interaction analysis of the thromboembolic risk in the left atrial appendage under atrial fibrillation: Effect of hemodynamics and morphological features.

BACKGROUND: Complications of atrial fibrillation (AF) include ischemic events originating within the left atrial appendage (LAA), a protrusion of the left atrium with variable morphological characteristics. The role of the patient specific morphology and pathological haemodynamics on the risk of ischemia remains unclear. METHODS: This work performs a comparative assessment of the hemodynamic parameters among patient-specific LAA morphologies through fluid-structure interaction computational analyses. Three LAA models per each of the four commons patient-specific morphological families (chicken wing, cactus, windsock, and cauliflower) were analysed. Mechanical properties of the tissue were based on experimental uniaxial tests on a young pig's heart. Boundary conditions were imposed based on clinical assessments of filling and emptying volumes. Sinus rhythm and atrial fibrillation operative conditions were simulated and analysed. RESULTS: For each model, the effect of morphological and functional parameters, such as the number of trabeculae and LAA stroke volume, over the hemodynamics established into the appendage was analysed. Comparison between results obtained in healthy and diseased conditions suggested the introduction of a new parameter to quantify the risk of thrombosis, here called blood stasis factor (BSF). This is defined as the LAA surface area which permanently experiences levels of shear strain rate inferior to a threshold value, set to 5 s-1 (BSF5). CONCLUSIONS: This work suggests that the current morphological classification is unsuitable to evaluate the probability of thrombus formation. However, hemodynamic parameters easy to determine from clinical examinations, such as normalised stroke volume, LAA orifice flow rate and presence of extensive trabeculations can identify departures from healthy hemodynamics in AF and support a more systematic stratification of the thromboembolic risk.

A novel mono-physics particle-based approach for the simulation of cardiovascular fluid-structure interaction problems.

BACKGROUND AND OBJECTIVE: Fluid-structure interaction (FSI) is required in the study of several cardiovascular engineering problems were the mutual interaction between the pulsatile blood flow and the tissue structures is essential to establish the biomechanics of the system. Traditional FSI methods are partitioned approaches where two independent solvers, one for the fluid and one for the structure, are asynchronously coupled. This process results into high computational costs. In this work, a new FSI scheme which avoids the coupling of different solvers is presented in the framework of the truly incompressible smoothed particle hydrodynamics (ISPH) method. METHODS: In the proposed FSI method, ISPH particles contribute to define both the fluid and structural domains and are solved together in a unified system. Solid particles, geometrically defined at the beginning of the simulation, are linked through spring bounds with elastic constant providing the material Young's modulus. At each iteration, internal elastic forces are calculated to restore the springs resting length. These forces are added in the predictor step of the fractional-step procedure used to solve the momentum and continuity equations for incompressible flows of all particles. RESULTS: The method was validated with a benchmark test case consisting of a flexible beam immersed in a channel. Results showed good agreement with the system coupling approach of a well-established commercial software, ANSYS®, both in terms of fluid-dynamics and beam deformation. The approach was then applied to model a complex cardiovascular problem, consisting in the aortic valve operating function. The valve dynamics during opening and closing phases were compared qualitatively with literature results, demonstrating good consistency. CONCLUSIONS: The method is computationally more efficient than traditional FSI strategies, and overcomes some of their main drawbacks, such as the impossibility of simulating the correct valve coaptation during the closing phase. Thanks to the incompressibility scheme, the proposed FSI method is appropriate to model biological soft tissues. The simplicity and flexibility of the approach also makes it suitable to be expanded for the modelling of thromboembolic phenomena.

Effect of the apron in the mechanical characterisation of hyperelastic materials by means of biaxial testing: A new method to improve accuracy.

Biological soft tissues and polymers used in biomedical applications (e.g. in the cardiovascular area) are hyperelastic incompressible materials that commonly operate under multi-axial large deformation fields. Their characterisation requires biaxial tensile testing. Due to the typically small sample size, the gripping of the specimens commonly relies on rakes or sutures, where the specimen is punctured at the edges of the gauge area. This approach necessitates of an apron, excess of material around the gauge region. This work analyses the apron influence on the estimated mechanical response of biaxial tests performed by using a rakes gripping system, with the aim of verifying the test accuracy and propose improved solutions. In order to isolate the effect of the apron, avoiding the influence of anisotropy and inhomogeneity typical of most soft tissues, homogeneous and isotropic hyperplastic samples made from a uniform sheet of casted silicone were tested. The stress-strain response of specimens with different apron sizes/shapes was measured experimentally by means of biaxial testing and digital image correlation. Tests were replicated numerically, to interpret the experimental findings. The apron surrounding the gauge area acts as an additional annular constraint which stiffens the system, resulting in a significant overestimate in the stress values. This error can be avoided by introducing specific cuts in the apron. The study quantifies, for the first time, the correlation between the apron size/shape and the experimental stress overestimation, proposing a research protocol which, although identified on homogeneous hyperelastic materials, can be useful in providing more accurate characterisation of both, synthetic polymers and soft tissues.

Valvulogenesis of a living, innervated pulmonary root induced by an acellular scaffold.

Heart valve disease is a major cause of mortality and morbidity worldwide with no effective medical therapy and no ideal valve substitute emulating the extremely sophisticated functions of a living heart valve. These functions influence survival and quality of life. This has stimulated extensive attempts at tissue engineering "living" heart valves. These attempts utilised combinations of allogeneic/ autologous cells and biological scaffolds with practical, regulatory, and ethical issues. In situ regeneration depends on scaffolds that attract, house and instruct cells and promote connective tissue formation. We describe a surgical, tissue-engineered, anatomically precise, novel off-the-shelf, acellular, synthetic scaffold inducing a rapid process of morphogenesis involving relevant cell types, extracellular matrix, regulatory elements including nerves and humoral components. This process relies on specific material characteristics, design and "morphodynamism".

Compliant Aortic Annulus Sizing With Different Elliptical Ratios Through a Valvuloplasty Balloon Catheter.

OBJECTIVE: Aortic stenos (AS) is a heart valve disease that commonly affects the elderly. Transcatheter aortic valve implantation is a minimally invasive treatment that allows to replace the function of the diseased native valve with a prosthetic device, relying on catheters for device implantation. According to the current clinical guidelines, the choice of the implanted device is based on preoperative sizing determined by image-based technology. However, this assessment faces inherent limitations that can lead to sub-optimal sizing of the prosthesis; in turn, this can cause major post-operative complications like aortic regurgitation or cardiac electrical signal disruption. METHOD: By utilizing balloon pressure and volume data, this article proposes an intra-operative method for determining the dimension of the aortic annulus which takes into account its compliance and geometric irregularity. The intra-balloon pressure-volume curves were obtained using an Automated Balloon Inflation Device operating a commercially available valvuloplasty balloon catheter. A sizing algorithm to estimate the dimensions of the annulus was integrated via a validated analytical model and a numerical model for balloon free-inflation. Tests were performed on circular and elliptical idealised aortic phantoms. RESULTS: Experimental results confirm that the pressure-volume data processed with the sizing algorithm can be used to determine the circular annular diameter for all tissue rigidities. CONCLUSION: The measurement of stiffer elliptical annulus phantoms shows good accuracy and high repeatability. SIGNIFICANCE: This work represents substantial progress toward improving the selection of TAVI devices by using balloon catheters to improve the sizing of compliant aortic annuli with complex geometry.

Modelling of thrombus formation using smoothed particle hydrodynamics method.

In this paper a novel model, based on the smoothed particle hydrodynamics (SPH) method, is proposed to simulate thrombus formation. This describes the main phases of the coagulative cascade through the balance of four biochemical species and three type of platelets. SPH particles can switch from fluid to solid phase when specific biochemical and physical conditions are satisfied. The interaction between blood and the forming blood clot is easily handled by an innovative monolithic FSI approach. Fluid-solid coupling is modelled by introducing elastic binds between solid particles, without requiring detention and management of the interface between the two media. The proposed model is able to realistically reproduce the thromboembolic process, as confirmed by the comparison of numerical results with experimental data available in the literature.

Hydrodynamic ex vivo analysis of valve-sparing techniques: assessment and comparison.

OBJECTIVES: Valve-sparing procedures are surgical techniques allowing to restore adequate function of the native aortic valve by replacing the dysfunctional ascending aorta with a prosthetic conduit. A number of techniques are currently used, such as Yacoub's remodelling and David's reimplantation, based on a regular straight conduit. More recently, the De Paulis proposed the use of bulging conduits to reconstruct the shape of the Valsalva sinuses. This work investigates the impact of the valve-sparing technique on the aortic valve function. METHODS: The performance of 3 porcine aortic roots (Medtronic Freestyle™) was assessed in a cardiovascular pulse duplicator before and after performing 3 alternative valve-sparing procedures: David's reimplantation, Yacoub's remodelling and De Paulis' reimplantation. RESULTS: The porcine aortic roots, representative of the healthy native configuration, were characterized by the highest efficiency, with a mean energetic dissipation under normal operating conditions of 26 mJ. David's and Yacoub's techniques resulted in significantly lower performance (with mean energetic loss of about 70 mJ for both cases). The De Paulis' procedure exhibited intermediate behaviour, with superior systolic performance and valve dynamics similar to the native case, and a mean energetic loss of 38 mJ. CONCLUSIONS: The dynamics and performance after valve-sparing strongly depend on the adopted technique, with the use of conduits replicating the presence of Valsalva sinuses restoring more physiological conditions.

Computational Analysis of Balloon Catheter Behaviour at Variable Inflation Levels.

Aortic valvuloplasty is a minimally invasive procedure for the dilatation of stenotic aortic valves. Rapid ventricular pacing is an established technique for balloon stabilization during this procedure. However, low cardiac output due to the pacing is one of the inherent risks, which is also associated with several potential complications. This paper proposes a numerical modelling approach to understand the effect of different inflation levels of a valvuloplasty balloon catheter on the positional instability caused by a pulsating blood flow. An unstretched balloon catheter model was crimped into a tri-folded configuration and inflated to several levels. Ten different inflation levels were then tested, and a Fluid-Structure Interaction model was built to solve interactions between the balloon and the blood flow modelled in an idealised aortic arch. Our computational results show that the maximum displacement of the balloon catheter increases with the inflation level, with a small step at around 50% inflation and a sharp increase after reaching 85% inflation. This work represents a substantial progress towards the use of simulations to solve the interactions between a balloon catheter and pulsating blood flow.

The Role of Patient-Specific Morphological Features of the Left Atrial Appendage on the Thromboembolic Risk Under Atrial Fibrillation.

Background: A large majority of thrombi causing ischemic complications under atrial fibrillation (AF) originate in the left atrial appendage (LAA), an anatomical structure departing from the left atrium, characterized by a large morphological variability between individuals. This work analyses the hemodynamics simulated for different patient-specific models of LAA by means of computational fluid-structure interaction studies, modeling the effect of the changes in contractility and shape resulting from AF. Methods: Three operating conditions were analyzed: sinus rhythm, acute atrial fibrillation, and chronic atrial fibrillation. These were simulated on four patient-specific LAA morphologies, each associated with one of the main morphological variants identified from the common classification: chicken wing, cactus, windsock, and cauliflower. Active contractility of the wall muscle was calibrated on the basis of clinical evaluations of the filling and emptying volumes, and boundary conditions were imposed on the fluid to replicate physiological and pathological atrial pressures, typical of the various operating conditions. Results: The LAA volume and shear strain rates were analyzed over time and space for the different models. Globally, under AF conditions, all models were well aligned in terms of shear strain rate values and predicted levels of risk. Regions of low shear rate, typically associated with a higher risk of a clot, appeared to be promoted by sudden bends and focused at the trabecule and the lobes. These become substantially more pronounced and extended with AF, especially under acute conditions. Conclusion: This work clarifies the role of active and passive contraction on the healthy hemodynamics in the LAA, analyzing the hemodynamic effect of AF that promotes clot formation. The study indicates that local LAA topological features are more directly associated with a thromboembolic risk than the global shape of the appendage, suggesting that more effective classification criteria should be identified.

Biological Equivalence of GGTA-1 Glycosyltransferase Knockout and Standard Porcine Pericardial Tissue Using 90-Day Mitral Valve Implantation in Adolescent Sheep.

OBJECTIVE: There is growing interest in the application of genetically engineered reduced antigenicity animal tissue for manufacture of bioprosthetic heart valves (BHVs) to reduce antibody induced tissue calcification and accelerated structural valve degeneration (SVD). This study tested biological equivalence of valves made from Gal-knockout (GalKO) and standard porcine pericardium after 90-day mitral valve implantation in sheep. METHODS: GalKO (n = 5) and standard (n = 5) porcine pericardial BHVs were implanted in a randomized and blind fashion into sheep for 90-days. Valve haemodynamic function was measured at 30-day intervals. After explantation, valves were examined for pannus, vegetation, inflammation, thrombus, and tissue calcification. RESULTS: Nine of 10 recipients completed the study. There was no difference between study groups for haemodynamic performance and no adverse valve-related events. Explanted BHVs showed mild pannus integration and minimal thrombus, with no difference between the groups. Limited focal mineral deposits were detected by x-ray. Atomic spectroscopy analysis detected tissue calcium levels of 1.0 µg/mg ± 0.2 for GalKO BHVs and 1.9 µg/mg ± 0.9 for standard tissue BHVs (p = 0.4), considered to be both low and equivalent. CONCLUSIONS: This is the first demonstration of biological equivalence between GalKO and standard pig pericardium. The GalKO mutation causes neither intrinsic detrimental biological nor functional impact on BHV performance. Commercial adaptation of GalKO tissue for surgical or transcatheter BHVs would remove the clinical disparity between patients producing anti-Gal antibody and BHVs containing the Gal antigen. GalKO BHVs may reduce accelerated tissue calcification and SVD, enhancing patient choices, especially for younger patients.

Investigation of the Thermomechanical Response of Cyclically Loaded NiTi Alloys by Means of Temperature Frequency Domain Analyses.

Nickel-Titanium (NiTi) shape memory alloys subjected to cyclic loading exhibit reversible temperature changes whose modulation is correlated with the applied load. This reveals the presence of reversible thermomechanical heat sources activated by the applied stresses. One such source is the elastocaloric effect, accounting for the latent heat of Austenite-Martensite phase transformation. It is, however, observed that when the amplitude of cyclic loads is not sufficient to activate or further propagate this phase transformation, the material still exhibits a strong cyclic temperature modulation. The present work investigates the thermomechanical behaviour of NiTi under such low-amplitude cyclic loading. This is carried out by analysing the frequency domain content of temperature sampled over a time window. The amplitude and phase of the most significant harmonics are obtained and compared with the theoretical predictions from the first and second-order theories of the Thermoelastic Effect, this being the typical reversible thermomechanical coupling prevailing under elastic straining. A thin strip of NiTi, exhibiting a fully superelastic behaviour at room temperature, was investigated under low-stress amplitude tensile fatigue cycling. Full-field strain and temperature distributions were obtained by means of Digital Image Correlation and IR Thermography. The work shows that the full field maps of amplitude and phase of the first three significant temperature harmonics carry out many qualitative information about the stress and structural state of the material. It is, though, found that the second-order theory of the Thermoelastic Effect is not fully capable of justifying some of the features of the harmonic response, and further work on the specific nature of thermomechanical heat sources is required for a more quantitative interpretation.

Experimental Validation of Enhanced Magnetic Resonance Imaging (EMRI) Using Particle Image Velocimetry (PIV).

Flow-sensitive four-dimensional Cardiovascular Magnetic Resonance Imaging (4D Flow CMR) has increasingly been utilised to characterise patients' blood flow, in association with patiens' state of health and disease, even though spatial and temporal resolutions still constitute a limit. Computational fluid dynamics (CFD) is a powerful tool that could expand these information and, if integrated with experimentally-obtained velocity fields, would enable to derive a large variety of the flow descriptors of interest. However, the accuracy of the flow parameters is highly influenced by the quality of the input data such as the anatomical model and boundary conditions typically derived from medical images including 4D Flow CMR. We previously proposed a novel approach in which 4D Flow CMR and CFD velocity fields are integrated to obtain an Enhanced 4D Flow CMR (EMRI), allowing to overcome the spatial-resolution limitation of 4D Flow CMR, and enable an accurate quantification of flow. In this paper, the proposed approach is validated in a U bend channel, an idealised model of the human aortic arch. The flow patterns were studied with 4D Flow CMR, CFD and EMRI, and compared with high resolution 2D PIV experiments obtained in pulsatile conditions. The main strengths and limitations of 4D Flow CMR and CFD were illustrated by exploiting the accuracy of PIV by comparing against PIV velocity fields. EMRI flow patterns showed a better qualitative and quantitative agreement with PIV results than the other techniques. EMRI enables to overcome the experimental limitations of MRI-based velocity measurements and the modelling simplifications of CFD, allowing an accurate prediction of complex flow patterns observed experimentally, while satisfying mass and momentum balance equations.

Effect of the Alterations in Contractility and Morphology Produced by Atrial Fibrillation on the Thrombosis Potential of the Left Atrial Appendage.

Atrial fibrillation (AF) is a common arrhythmia mainly affecting the elderly population, which can lead to serious complications such as stroke, ischaemic attack and vascular dementia. These problems are caused by thrombi which mostly originate in the left atrial appendage (LAA), a small muscular sac protruding from left atrium. The abnormal heart rhythm associated with AF results in alterations in the heart muscle contractions and in some reshaping of the cardiac chambers. This study aims to verify if and how these physiological changes can establish hemodynamic conditions in the LAA promoting thrombus formation, by means of computational fluid dynamic (CFD) analyses. In particular, sinus and fibrillation contractility was replicated by applying wall velocity/motion to models based on healthy and dilated idealized shapes of the left atrium with a common LAA morphology. The models were analyzed and compared in terms of shear strain rate (SSR) and vorticity, which are hemodynamic parameters directly associated with thrombogenicity. The study clearly indicates that the alterations in contractility and morphology associated with AF pathologies play a primary role in establishing hemodynamic conditions which promote higher incidence of ischaemic events, consistently with the clinical evidence. In particular, in the analyzed models, the impairment in contractility determined a decrease in SSR of about 50%, whilst the chamber pathological dilatation contributed to a 30% reduction, indicating increased risk of clot formation. The equivalent rigid wall model was characterized by SSR values about one order of magnitude smaller than in the contractile models, and substantially different vortical behavior, suggesting that analyses based on rigid chambers, although common in the literature, are inadequate to provide realistic results on the LAA hemodynamics.

Does transcatheter aortic valve alignment matter?

Objective: This study investigates the effect of transcatheter aortic valve (TAV) angular alignment on the postprocedure haemodynamics. TAV implantation has emerged as an effective alternative to surgery when treating valve dysfunction. However, the benefit of avoiding surgery is paid back by the inability to remove the native diseased leaflets and accurately position the device in relation to the aortic root, and the literature has shown the root anatomy and substitute position can play an essential role on valve function. Methods: A commercial TAV was placed in a silicone mock aortic root in vitro, including mock native leaflets, and either aligned commissure-to-commissure or in maximum misalignment. Haemodynamic performance data at various stroke volumes were measured, and Particle Image Velocimetry analysis was performed at a typical stroke volume for rest conditions. The two configurations were also studied without mock native leaflets, for comparison with previous in vitro studies. Results: Haemodynamic performance data were similar for all configurations. However, imaging analysis indicated that valve misalignment resulted in the central jet flow not extending to the root wall in the native commissures' vicinity, replaced by a low shear flow, and a reduction of upper sinus flow of 40%, increasing flow stagnation in the sinus. Conclusions: TAV misalignment did not result in a significant change in valve hydrodynamic performance, but determined some change in the fluid flow patterns, which may promote pathological scenarios, such as increased thrombogenicity of blood flow within the sinuses of Valsalva, and plaque formation around the lumen of the sinotubular junction.

The neochord mitral valve repair procedure: Numerical simulation of different neochords tensioning protocols.

Transapical off-pump mitral valve repair with neochord implantation is an established technique for minimally-invasive intervention on mitral valve prolapse/flail. The procedure involves the positioning of artificial chords, whose length/tension is adjusted intraoperatively, adopting different methods based on the experience of the surgeon. This unsystematic approach occasionally leads to complications such as leaflet rupture and excessive/insufficient load on the neochords. In this study, finite element models of a generalized prolapsing mitral valve are used to verify the effect of two alternative tensioning approaches (AT - All together and 1-by-1 - one by one sequences) on the coaptation area and valve biomechanics, comparing results with a corresponding healthy configuration. The total force of about 1 N is exerted by the chords in both strategies, but the maximum stress and coaptation area are closer to those of the healthy configuration in the 1-by-1 sequence. However, the analysis also provides an explanation for the chords unloading in the 1-by-1 strategy observed in the clinical practice, and suggests an optimum tensioning methodology for NeoChord procedures. The study also reveals the potential power of the implemented numerical approach to serve as a tool for procedural planning, supporting the identification of the most suitable ventricular access site and the most effective stitching points for the artificial chords.

In Vitro and Ex Vivo Hemodynamic Testing of an Innovative Occluder for Paravalvular Leak After Transcather Aortic Valve Implantation.

This study aims at achieving a proof-of-concept for a novel device designed to occlude the orifices that may form between transcatheter valves and host tissues after TAVI. The device effect on the performance of a SAPIEN XT with a paravalvular gap was assessed into an in vitro and ex vivo pulse duplicator. The in vitro tests were performed complying with the standard international regulations, measuring the trasvalvular pressure and regurgitant volumes with and without the paravalvular gap, and with the occluder correctly positioned into the gap. In the second series of tests, the leakage reduction due to the presence of the occluder was assessed for the same setup, into a beating swine heart. The occluder implantation decreased the regurgitant fraction of about 50% for the in vitro assessment and 75% for the ex vivo test, under rest operating conditions. These results suggest that suitably designed occluders can lead to important benefit in the PVL treatment.

Incidence, predictors and cerebrovascular consequences of leaflet thrombosis after transcatheter aortic valve implantation: a systematic review and meta-analysis.

OBJECTIVES: We examined the incidence, the impact of subsequent cerebrovascular events and the clinical or procedural predictors of leaflet thrombosis (LT) in patients undergoing transcatheter aortic valve implantation (TAVI). METHODS: MEDLINE/PubMed was systematically screened for studies reporting on LT in TAVI patients. Incidence [both clinical and subclinical, i.e. detected with computed tomography (CT)] of LT was the primary end point of the study. Predictors of LT evaluated at multivariable analysis and impact of LT on stroke were the secondary ones. RESULTS: Eighteen studies encompassing 11 124 patients evaluating incidence of LT were included. Pooled incidence of LT was 0.43% per month [5.16% per year, 95% confidence interval (CI) 0.21-0.72, I2 = 98%]. Pooled incidence of subclinical LT was 1.36% per month (16.32% per year, 95% CI 0.71-2.19, I2 = 94%). Clinical LT was less frequent (0.04% per month, 0.48% per year, 95% CI 0.00-0.19, I2 = 93%). LT increased the risk of stroke [odds ratio (OR) 4.21, 95% CI 1.27-13.98], and was more frequent in patients with a valve diameter of 28-mm (OR 2.89: 1.55-5.8), for balloon-expandable (OR 8: 2.1-9.7) or after valve-in-valve procedures (OR 17.1: 3.1-84.9). Oral anticoagulation therapy reduced the risk of LT (OR 0.43, 95% CI: 0.22-0.84, I2 = 64%), as well as the mean transvalvular gradient. CONCLUSIONS: LT represents an infrequent event after TAVI, despite increasing risk of stroke. Given its full reversal with warfarin, in high-risk patients (those with valve-in-valve procedures, balloon expandable or large-sized devices), a protocol which includes a control CT appears reasonable.

In vitro assessment of pacing as therapy for aortic regurgitation.

Background and objective: Clinical evaluation of pacing therapy in mitigating the aortic insufficiency after transchateter aortic valve implantation often gives contradictory outcomes. This study presents an in vitro investigation aimed at clarifying the effect of pacing on paravalvular leakage. Methods: A series of in vitro tests reproducing the heart operating changes clinically obtained by pacing was carried out in a 26 mm Edwards Sapien XT prosthesis with mild paravalvular leakage. The effect of pacing on the regurgitant volumes per cycle and per minute was quantified, and the energy and power consumed by the left ventricle were calculated. Results: Results indicate that though pacing results in some reduction in the total regurgitation per cycle, the volume of fluid regurgitating per minute increases substantially, causing overload of left ventricle. Conclusions: Our tests indicate no effective haemodynamic benefit from pacing, suggesting a prudential clinical use of this therapy for the treatment of postoperative aortic regurgitation.

A Durable Porcine Pericardial Surgical Bioprosthetic Heart Valve: a Proof of Concept.

Bioprosthetic leaflets made from animal tissues are used in the majority of surgical and transcatheter cardiac valve replacements. This study develops a new surgical bioprosthesis, using porcine pericardial leaflets. Porcine pericardium was obtained from genetically engineered pigs with a mutation in the GGTA-1 gene (GTKO) and fixed in 0.6% glutaraldehyde, and used to develop a new surgical valve design. The valves underwent in vitro hydrodynamic test in a pulse duplicator and high-cycled accelerated wear testing and were evaluated for acute haemodynamics and thrombogenicity in a juvenile sheep implant study for 48 h. The porcine surgical pericardial heart valves (pSPHVs) exhibited excellent hydrodynamics and reached 200 million cycles of in vitro durability, with no observable damage. Juvenile sheep implants demonstrated normal valve function with no acute thrombogenic response for either material. The pSPHV incorporates a minimalistic construction method using a tissue-to-tissue design to cover the stent. This new design is a proof of concept alternative to the use of bovine pericardium and synthetic fabric in surgical bioprosthetic heart valves.