Cardiovascular Engineering and Technology最新文献

Purpose

The development of new endovascular technologies for transarterial embolization has relied on animal studies to validate efficacy before clinical trials are undertaken. Because embolizations in animals and patients are primarily conducted with fluoroscopy alone, local hemodynamic changes are not assessed during testing. However, such hemodynamic metrics could be important indicators of procedure efficacy that could support improved patient outcomes, such as via the determination of procedural endpoints. The purpose of this study is to create a high-fidelity benchtop system for multiparametric (i.e., hemodynamic and imaging) assessment of transarterial embolization procedures.

Methods

The benchtop system consists of a 3D printed, anatomically accurate vascular phantom; a flow loop with a cardiac output simulator; a high-speed video camera; and pressure transducers and flow meters. This system enabled us to vary the heart rate and blood pressure and to simulate clinically relevant hemodynamic states, such as healthy adult, aortic regurgitation, and hypovolemic shock.

Results

With our radiation-free angiography-mimetic imaging system, we could simultaneously assess gauge pressure and flow values during transarterial embolization. We demonstrated the feasibility of recapitulating the digital subtraction angiography workflow. Finally, we highlighted the utility of this system by characterizing the relationship between an imaging-based metric of procedural endpoint and intravascular flow. We also characterized hemodynamic changes associated with particle embolization within a branch of the hepatic artery and found them to be within reported patient data.

Conclusion

Our benchtop vascular system was low-cost and reproduced transarterial embolization-related hemodynamic phenomena with high fidelity. We believe that this novel platform enables the characterization of patient physiology, novel catheterization devices, and techniques.

Purpose

Neo-sinus flow stasis has ben correlated with transcatheter heart valve (THV) thrombosis severity and occurrence. Standard benchtop flow field quantification techniques require optical access or modified prosthesis models that may not reflect the true nature of the original valve. En face and fluoroscopic videodensitometry enable visualization of washout in regions otherwise unviewable.

Methods

This study compares two in vitro methods of assessing flow stasis in scenarios with insufficient optical access for traditional techniques such as particle image velocimetry (PIV). A series of seven paired experiments were conducted using a previously described laser-enhanced video densitometry (LEVD) and fluoroscopic video densitometry (FVD). Both sets of experiments were analyzed to calculate washout time as a measure of flow stasis. A novel flow stasis measure termed contrast attenuation ratio (CAR) is proposed as a viable single measure of flow stasis obtainable from only a small number of cardiac cycles of in vitro or in vivo fluoroscopic data. Retrospective fluoroscopic datasets (n = 72) were analyzed to assess the feasibility of obtaining this metric from routine clinical practice and its ability to stratify results.

Results

Neo-sinus flow stasis calculated from in vitro fluoroscopy was well correlated with LEVD (r² = 0.77, p = 0.009). The newly proposed CAR metric showed good agreement with the commonly used “washout time” measure of flow stasis (r² = 0.91, p < 0.001) while allowing for assessment with incomplete or truncated data. As a proof of concept, CAR was measured in 72 consecutive retrospective fluoroscopic datasets. CAR averaged 10.6 ± 4.6% with a range of 1.5–20.3% in these patients.

Conclusions

This study demonstrates two in vitro methods that can be used to assess relative flow stasis in otherwise optically inaccessible regions surrounding cardiac or vascular implants. In addition, the fluoroscopic benchtop technique was used to validate a metric that allows for extension to routine clinical fluoroscopy. This contrast attenuation ratio (CAR) metric was found to be both accurate and clinically obtainable, and potentially offers a new method for valve thrombosis risk stratification.

Purpose: To address the clinical need for totally implantable mechanical circulatory support devices, Bionet Sonar is developing a novel Ultrasonic Transcutaneous Energy Transmission (UTET) system that is designed to eliminate external power and/or data communication drivelines.

Methods: UTET systems were designed, fabricated, and pre-clinically tested using a non-clinical HeartWare HVAD in static and dynamic mock flow loop and acute animal models over a range of pump speeds (1800, 2400, 3000 RPM) and tissue analogue thicknesses (5, 10, 15 mm).

Results: The prototypes demonstrated feasibility as evidenced by meeting/exceeding function, operation, and performance metrics with no system failures, including achieving receiver (harvested) power exceeding HVAD power requirements and data communication rates of 10kB/s and pump speed control (> 95% sensitivity and specificity) for all experimental test conditions, and within healthy tissue temperature range with no acute tissue damage.

Conclusion: During early-stage development and testing, engineering challenges for UTET size reduction and stable and safe operation were identified, with solutions and plans to address the limitations in future design iterations also presented.

Purpose: The purpose is to demonstrate the difference in closing volume fraction between the single opening&closing valve tester (SOCVT) and continuous pulsatile flow valve tester (CPFVT).

Methods: A comparative study was conducted in four hemodynamic conditions selected from the ISO 5840 on the four mitral valve states: normal annulus, 40% annulus dilation, 60% annulus dilation, and repaired valve with a clip device in both the SOCVT and CPFVT. The closing volume fractions were compared and errors calculated in the 16 cases.

Results: In the CPFVT, the flowrate waveform depends more on hemodynamic conditions rather than the valve morphology. For closing volume fractions in the two testers, twelve cases had errors between 10% and 20% and 3 cases had errors between 2.2% and 5.5%. There was no statistic difference in the closing volume fraction between the CPFVT and SOCVT for the normal annulus, 40% valve annulus dilation, 60% valve annulus dilation and repaired valves (P values = 0.44, 0.44, 0.33, and 0.08, respectively, n = 4).

Conclusion: There is certain error in closing volume measurements, even if no statistic difference in closing volume measured by the SOCVT and CPFVT. The typical flow waveforms of the mitral valve may be available to standardize testing of the SOCVT to evaluate valve hemodynamics. The SOCVT may be an alternative to the valve testing.

Purpose: To introduce a computational tool for peri-interventional intracranial aneurysm treatment guidance that maps preoperative planning information from simulation onto real-time X-Ray imaging.

Methods: Preoperatively, multiple flow diverter (FD) devices are simulated based on the 3D mesh of the vessel to treat, to choose the optimal size and location. In the peri-operative stage, this 3D information is aligned and mapped to the continuous 2D-X-Ray scan feed from the operating room. The current flow diverter position in the 3D model is estimated by automatically detecting the distal FD marker locations and mapping them to the treated vessel. This allows to visually assess the possible outcome of releasing the device at the current position, and compare it with the one chosen pre-operatively.

Results: The full pipeline was validated using retrospectively collected biplane images from four different patients (5 3D-DSA datasets in total). The distal FD marker detector obtained an average F1-score of 0.67 ( $\pm 0.224$ ) in 412 2D-X-Ray scans. After aligning 3D-DSA + 2D-X-Ray datasets, the average difference between simulated and deployed positions was 0.832 mm ( $\pm 0.521$ mm). Finally, we qualitatively show that the proposed approach is able to display the current location of the FD compared to their pre-operatively planned position.

Conclusions: The proposed method allows to support the FD deployment procedure by merging and presenting preoperative simulation information to the interventionists, aiding them to make more accurate and less risky decisions.

Purpose: Myocardial infarction (MI) is a leading cause of irreversible functional cardiac tissue loss, requiring novel regenerative strategies. This study assessed the potential therapeutic efficacy of recellularized cardiac patches, incorporating fetal myocardial scaffolds with rat fetal cardiomyocytes and acellular human amniotic membrane, in adult Wistar rat models of MI.

Methods: Decellularized myocardial tissue was obtained from 14 to 16 week-old human fetuses that had been aborted. Chemical detergents (0.1% EDTA and 0.2% sodium dodecyl sulfate) were used to prepare the fetal extracellular matrix (ECM), which was characterized for bio-scaffold microstructure and biocompatibility via scanning electron microscopy (SEM) and MTT assay, respectively. Neonatal cardiomyocytes were extracted from the ventricles of one-day-old Wistar rats' littermates and characterized through immunostaining against Connexin-43 and α-smooth muscle actin. The isolated cells were seeded onto decellularized tissues and covered with decellularized amniotic membrane. Sixteen healthy adult Wistar rats were systematically allocated to control and MI groups. MI was induced via arterial ligation. Fourteen days post-operation, the MI group was received the engineered patches. Following a two-week post-implantation period, the animals were euthanized, and the hearts were harvested for the graft evaluation.

Results: Histological analysis, DAPI staining, and ultra-structural examination corroborated the successful depletion of cellular elements, while maintaining the integrity of the fetal ECM and architecture. Subsequent histological and immunohistochemichal (IHC) evaluations confirmed effective cardiomyocyte seeding on the scaffolds. The application of these engineered patches in MI models resulted in increased angiogenesis, reduced fibrosis, and restricted scar tissue formation, with the implanted cardiomyocytes remaining viable at graft sites, indicating prospective in vivo cell viability.

Conclusions: This study suggests that multi-layered recellularized cardiac patches are a promising surgical intervention for myocardial infarction, showcasing significant potential by promoting angiogenesis, mitigating fibrosis, and minimizing scar tissue formation in MI models. These features are pivotal for enhancing the therapeutic outcomes in MI patients, focusing on the restoration of the myocardial structure and function post-infarction.

Purpose: The Wall Shear Stress (WSS) is the component tangential to the boundary of the normal stress tensor in an incompressible fluid, and it has been recognized as a quantity of primary importance in predicting possible adverse events in cardiovascular diseases, in general, and in coronary diseases, in particular. The quantification of the WSS in patient-specific settings can be achieved by performing a Computational Fluid Dynamics (CFD) analysis based on patient geometry, or it can be retrieved by a numerical approximation based on blood flow velocity data, e.g., ultrasound (US) Doppler measurements. This paper presents a novel method for WSS quantification from 2D vector Doppler measurements.

Methods: Images were obtained through unfocused plane waves and transverse oscillation to acquire both in-plane velocity components. These velocity components were processed using pseudo-spectral differentiation techniques based on Fourier approximations of the derivatives to compute the WSS.

Results: Our Pseudo-Spectral Method (PSM) is tested in two vessel phantoms, straight and stenotic, where a steady flow of 15 mL/min is applied. The method is successfully validated against CFD simulations and compared against current techniques based on the assumption of a parabolic velocity profile. The PSM accurately detected Wall Shear Stress (WSS) variations in geometries differing from straight cylinders, and is less sensitive to measurement noise. In particular, when using synthetic data (noise free, e.g., generated by CFD) on cylindrical geometries, the Poiseuille-based methods and PSM have comparable accuracy; on the contrary, when using the data retrieved from US measures, the average error of the WSS obtained with the PSM turned out to be 3 to 9 times smaller than that obtained by state-of-the-art methods.

Conclusion: The pseudo-spectral approach allows controlling the approximation errors in the presence of noisy data. This gives a more accurate alternative to the present standard and a less computationally expensive choice compared to CFD, which also requires high-quality data to reconstruct the vessel geometry.

Purposr: This study created 3D CFD models of the Norwood procedure for hypoplastic left heart syndrome (HLHS) using standard angiography and echocardiogram data to investigate the impact of shunt characteristics on pulmonary artery (PA) hemodynamics. Leveraging routine clinical data offers advantages such as availability and cost-effectiveness without subjecting patients to additional invasive procedures.

Methods: Patient-specific geometries of the intrathoracic arteries of two Norwood patients were generated from biplane cineangiograms. "Virtual surgery" was then performed to simulate the hemodynamics of alternative PA shunt configurations, including shunt type (modified Blalock-Thomas-Taussig shunt (mBTTS) vs. right ventricle-to-pulmonary artery shunt (RVPAS)), shunt diameter, and pulmonary artery anastomosis angle. Left-right pulmonary flow differential, Q_p/Q_s, time-averaged wall shear stress (TAWSS), and oscillatory shear index (OSI) were evaluated.

Results: There was strong agreement between clinically measured data and CFD model output throughout the patient-specific models. Geometries with a RVPAS tended toward more balanced left-right pulmonary flow, lower Q_p/Q_s, and greater TAWSS and OSI than models with a mBTTS. For both shunt types, larger shunts resulted in a higher Q_p/Q_s and higher TAWSS, with minimal effect on OSI. Low TAWSS areas correlated with regions of low flow and changing the PA-shunt anastomosis angle to face toward low TAWSS regions increased TAWSS.

Conclusion: Excellent correlation between clinically measured and CFD model data shows that 3D CFD models of HLHS Norwood can be developed using standard angiography and echocardiographic data. The CFD analysis also revealed consistent changes in PA TAWSS, flow differential, and OSI as a function of shunt characteristics.

Purpose: In-vitro modelling can be used to investigate haemodynamics of arterial geometry and stent implants. However, in-vitro model fidelity relies on precise matching of in-vivo conditions. In pulsatile flow, velocity distribution and wall shear stress depend on compliance, and the Reynolds and Womersley numbers. However, matching such values may lead to unachievable tolerances in phantom fabrication.

Methods: Published Reynolds and Womersley numbers for 14 major arteries in the human body were determined via a literature search. Preference was given to in-vivo publications but in-vitro and in-silico values were presented when in-vivo values were not found. Subsequently ascending aorta and carotid artery case studies were presented to highlight the limitations dynamic matching would apply to phantom fabrication.

Results: Seven studies reported the in-vivo Reynolds and Womersley numbers for the aorta and two for the carotid artery. However, only one study each reported in-vivo numbers for the remaining ten arteries. No in-vivo data could be found for the femoral, superior mesenteric and renal arteries. Thus, information derived in-vitro and in-silico were provided instead. The ascending aorta and carotid artery models required scaling to 1.5× and 3× life-scale, respectively, to achieve dimensional tolerance restrictions. Modelling the ascending aorta with the comparatively high viscosity water/glycerine solution will lead to high pump power demands. However, all the working fluids considered could be dynamically matched with low pump demand for the carotid model.

Conclusion: This paper compiles available human haemodynamic information, and highlights the paucity of information for some arteries. It also provides a method for optimal in-vitro experimental configuration.

Purpose: Prior studies have indicated an impact of cardiac muscle viscoelasticity on systolic and diastolic functions. However, the studies of ventricular free wall viscoelasticity, particularly for that of right ventricles (RV), are limited. Moreover, investigations on ventricular passive viscoelasticity have been restricted to large animals and there is a lack of data on rodent species. To fill this knowledge gap, this study aims to develop a biaxial tester that induces high-speed physiological deformations to characterize the passive viscoelasticity of rat RVs.

Methods: The biaxial testing system was fabricated so that planar deformation of rat ventricle tissues at physiological strain rates was possible. The testing system was validated using isotropic polydimethylsiloxane (PDMS) sheets. Next, viscoelastic measurements were performed in healthy rat RV free walls by equibiaxial cyclic sinusoidal loadings and stress relaxation.

Results: The biaxial tester's consistency, accuracy, and stability was confirmed from the PDMS samples measurements. Moreover, significant viscoelastic alterations of the RV were found between sub-physiological (0.1 Hz) and physiological frequencies (1-8 Hz). From hysteresis loop analysis, we found as the frequency increased, the elasticity and viscosity were increased in both directions. Interestingly, the ratio of storage energy to dissipated energy (W_d/W_s) remained constant at 0.1-5 Hz. We did not observe marked differences in healthy RV viscoelasticity between longitudinal and circumferential directions.

Conclusion: This work provides a new experimental tool to quantify the passive, biaxial viscoelasticity of ventricle free walls in both small and large animals. The dynamic mechanical tests showed frequency-dependent elastic and viscous behaviors of healthy rat RVs. But the ratio of dissipated energy to stored energy was maintained between frequencies. These findings offer novel baseline information on the passive viscoelasticity of healthy RVs in adult rats.