Investigation of Cerebral Hemodynamics During Endovascular Aspiration: Development of an Experimental and Numerical Setup.

PURPOSE: Acute ischemic stroke is a life-threatening emergency caused by an occlusion of a cerebral artery through a blood clot. Aspiration thrombectomy is an endovascular therapy for the removal of vessel occlusions. However, open questions regarding the hemodynamics during the intervention remain, motivating investigations of blood flow within cerebral arteries. In this study, we present a combined experimental and numerical approach to analyze hemodynamics during endovascular aspiration. METHODS: We have developed an in vitro setup for investigations of hemodynamic changes during endovascular aspiration within a compliant model of patient-specific cerebral arteries. Pressures, flows, and locally resolved velocities were obtained. In addition, we established a computational fluid dynamics (CFD) model and compared the simulations during physiological conditions and in two aspiration scenarios with different occlusions. RESULTS: Flow redistribution within cerebral arteries after ischemic stroke is strongly dependent on the severity of the occlusion and on the volume flow extracted by endovascular aspiration. Numerical simulations exhibit an excellent correlation of R = 0.92 for flow rates and a good correlation of R = 0.73 for pressures. Further on, the local velocity field inside the basilar artery had a good agreement between CFD model and particle image velocimetry (PIV) data. CONCLUSION: The presented setup allows for in vitro investigations of artery occlusions and endovascular aspiration techniques on arbitrary patient-specific cerebrovascular anatomies. The in silico model provides consistent predictions of flows and pressures in several aspiration scenarios.

In Vitro Calcification of Bioprosthetic Heart Valves: Test Fluid Validation on Prosthetic Material Samples.

Calcification is a major failure mode of bioprosthetic heart valves. So far, cost and time saving in vitro analyses of calcification potentials are unreliable, mostly due to superficial or spontaneous precipitation of the applied fluids. In this study, we developed a near-physiological non-spontaneously precipitating fluid for an accelerated in vitro calcification assessment, and validated it by analyzing the calcification potential of two prosthetic materials within two reference-tests. The first test focused on the comparison of four calcification fluids under dynamic contact with n=12 commercial bovine pericardium patches. The second one focused on the validation of the most appropriate fluid by analyzing the calcification potential of pericardium vs. polyurethane. The patches were mounted in separate test compartments and treated simultaneously with the respective fluids at an accelerated test frequency. Calcification propensity and progression were detected macroscopically and microscopically. Structural analyses of all deposits indicated hydroxyapatite by X-ray powder diffraction, which is also most commonly observed in vivo. Histological examination by von Kossa staining showed matrix internal and superficial calcifications, depending on the fluid composition. The present study reveals promising results towards the development of a meaningful, cost and time saving in vitro analysis of the calcification potential of bioprosthetic heart valves.

Long-Term Venovenous Connection for Extracorporeal Carbon Dioxide Removal (ECCO2R)-Numerical Investigation of the Connection to the Common Iliac Veins.

PURPOSE: Currently used cannulae for extracorporeal carbon dioxide removal (ECCO2R) are associated with complications such as thrombosis and distal limb ischemia, especially for long-term use. We hypothesize that the risk of these complications is reducible by attaching hemodynamically optimized grafts to the patient's vessels. In this study, as a first step towards a long-term stable ECCO2R connection, we investigated the feasibility of a venovenous connection to the common iliac veins. To ensure its applicability, the drainage of reinfused blood (recirculation) and high wall shear stress (WSS) must be avoided. METHODS: A reference model was selected for computational fluid dynamics, on the basis of the analysis of imaging data. Initially, a sensitivity analysis regarding recirculation was conducted using as variables: blood flow, the distance of drainage and return to the iliocaval junction, as well as the diameter and position of the grafts. Subsequently, the connection was optimized regarding recirculation and the WSS was evaluated. We validated the simulations in a silicone model traversed by dyed fluid. RESULTS: The simulations were in good agreement with the validation measurements (mean deviation 1.64%). The recirculation ranged from 32.1 to 0%. The maximum WSS did not exceed 5.57 Pa. The position and diameter of the return graft show the highest influence on recirculation. A correlation was ascertained between recirculation and WSS. Overall, an inflow jet directed at a vessel wall entails not only high WSS, but also a flow separation and thereby an increased recirculation. Therefore, return grafts aligned to the vena cava are crucial. CONCLUSION: In conclusion, a connection without recirculation could be feasible and therefore provides a promising option for a long-term ECCO2R connection.

In Vitro Calcification of Bioprosthetic Heart Valves: Investigation of Test Fluids.

Calcification is a major reason for the failure of bioprosthetic heart valves. Therefore, several attempts towards an accelerated in vitro model were undertaken in order to provide a cost- and time-saving method for the analysis of calcification processes. Due to the problem of superficial or spontaneous precipitation, which occurred in the fluids applied, we focused our study on the development of a near-physiological calcification fluid. The desired fluid should not precipitate spontaneously and should neither promote nor inhibit calcification. Eleven different fluid compositions were tested without contact to potentially calcifying materials. Crucial factors regarding the fluid properties were the ionic product, the ionic strength, and the degree of supersaturation concerning dicalciumphosphate-dihydrate, octacalciumphosphate, and hydroxyapatite. The fluids were kept in polyethylene bottles and exposed to a slight vibration within a durability tester at 37 °C. The precipitation propensity was monitored optically and colorimetrically. A structural analysis of the deposits was carried out by x-ray powder diffraction and IR-spectroscopy, which showed the development of the crystal phases that are relevant in vivo. Only two of the fluids did not precipitate. Resulting from the computations of the effective fluid contents, the saturation degree concerning dicalciumphosphate-dihydrate seems to be the key factor for spontaneous precipitation.

Reliability of left atrial pressure estimation from left ventricular filling measurement in a total artificial heart.

A physiological control of a total artificial heart (TAH) requires reliable information on left arterial pressure (LAP). When LAP is derived indirectly from intrinsic TAH parameters like end diastolic volume (EDV) and diastole duration (Td), the transfer function and associated uncertainties need to be well understood.We derived a computational equivalent to a hydraulic model consisting of the venous compliance, the heart valve and the pump chamber, and studied the filling phase in cases of different venous compliance. We calculated a family of curves of pump chamber volume as a function of time for different venous compliances and LAP. To visualize the LAP transfer function and uncertainties associated to EDV, Td measurement error and unknown venous compliance a family of similar curves in the vicinity of assumed measurement was found and visualised in the parameter space.Results were in a realistic absolute range and showed expected trends despite some simplifications in the simulation model. The venous compliance has no significant influence on LAP values extracted from EDV and Td, except at very low values. The uncertainty in the extracted LAP is particularly high for high EDV and short Td.A physiological regulation therefore does not have to be individually adapted to the patient's venous compliances, but has to deal with uncertainties in the input values like blood pressures extracted from intrinsic device parameters.

Evaluation of platelet adhesion and activation on polymers: Round-robin study to assess inter-center variability.

The regulatory agencies provide recommendations rather than protocols or standard operation procedures for the hemocompatibility evaluation of novel materials e.g. for cardiovascular applications. Thus, there is a lack of specifications with regard to test setups and procedures. As a consequence, laboratories worldwide perform in vitro assays under substantially different test conditions, so that inter-laboratory and inter-study comparisons are impossible. Here, we report about a prospective, randomized and double-blind multicenter trial which demonstrates that standardization of in vitro test protocols allows a reproducible assessment of platelet adhesion and activation from fresh human platelet rich plasma as possible indicators of the thrombogenicity of cardiovascular implants. Standardization of the reported static in vitro setup resulted in a laboratory independent scoring of the following materials: poly(dimethyl siloxane) (PDMS), poly(ethylene terephthalate) (PET) and poly(tetrafluoro ethylene) (PTFE). The results of this in vitro study provide evidence that inter-laboratory and inter-study comparisons can be achieved for the evaluation of the adhesion and activation of platelets on blood-contacting biomaterials by stringent standardization of test protocols.

Evaluation of cover effects on bare stent mechanical response.

Covered tracheobronchial stents are used to prevent tumour growth from reoccluding the airways. In the present work a combination of experimental and computational methods are used to present the mechanical effects that adhered covers can have on stent performance. A prototype tracheobronchial stent is characterised in bare and covered configurations using radial force, flat plate and a novel non-uniform radial force test, while computational modelling is performed in parallel to extensively inform the physical testing. Results of the study show that cover configuration can have a significant structural effect on stent performance, and that stent response (bare or covered) is especially loading specific, highlighting that the loading configuration that a stent is about to be subjected to should be considered before stent implantation.

In Vitro Evaluation of Intra-Aneurysmal, Flow-Diverter-Induced Thrombus Formation: A Feasibility Study.

BACKGROUND AND PURPOSE: Intracranial aneurysm treatment by flow diverters aims at triggering intra-aneurysmal thrombosis. By combining in vitro blood experiments with particle imaging velocimetry measurements, we investigated the time-resolved thrombus formation triggered by flow diverters. MATERIALS AND METHODS: Two test setups were built, 1 for particle imaging velocimetry and 1 for blood experiments, both generating the same pulsatile flow and including a silicone aneurysm model. Tests without flow diverters and with 2 different flow-diverter sizes (diameter: 4.5 and 4.0 mm) were performed. In the blood experiments, the intra-aneurysmal flow was monitored by using Doppler sonography. The experiments were stopped at 3 different changes of the spatial extent of the signal. RESULTS: No thrombus was detected in the aneurysm model without the flow diverter. Otherwise, thrombi were observed in all aneurysm models with flow diverters. The thrombi grew from the proximal side of the aneurysm neck with fibrin threads connected to the flow diverter and extending across the aneurysm. The thrombus resulting from the 4.0-mm flow diverter grew along the aneurysm wall as a solid and organized thrombus, which correlates with the slower velocities near the wall detected by particle imaging velocimetry. The thrombus that evolved by using the 4.5-mm flow diverter showed no identifiable growing direction. The entire thrombus presumably resulted from stagnation of blood and correlates with the central vortex detected by particle imaging velocimetry. CONCLUSIONS: We showed the feasibility of in vitro investigation of time-resolved thrombus formation in the presence of flow diverters.

Influence of aortic dimensions on the hemodynamic performance of small aortic valve prostheses: impact on patient/prosthesis mismatch.

BACKGROUND: Since Doppler echocardiography takes no account of pressure recovery, the true hemodynamic burden of aortic valve prostheses remains vague. The purpose of this study was to elucidate the methodological error of Doppler gradient estimation by means of a model demonstrating the different influence of aortic root diameters on net and Doppler gradients, respectively. This matters especially in small valves and the related patient/prosthesis mismatch calculation. METHODS: Two bileaflet small aortic valve prostheses (19 mm SJM Regent® and On-X® valve) were tested using a pulsatile circulatory mock loop simulator with two different aortic models: one with statistically normal diameters according to annular size, another one simulating an aortic aneurysm of 50 mm. Doppler and simultaneously recorded net gradients as well as systolic energy losses were obtained for different hemodynamic conditions. RESULTS: In all measurements a significant amount of pressure recovery was observed. In cases of aortic aneurysm systolic energy loss increased significantly for each cardiac output at each heart rate ( P < 0.0028), reflected by a significant ( P < 0.0001) increase in net gradients. The corresponding Doppler gradients were unchanged. This indicates significantly less pressure recovery ( P < 0.0001) in the aneurysmatic aorta. CONCLUSIONS: Geometry of the ascending aorta considerably alters aortic valve hemodynamic parameters. The hemodynamic function of small aortic valve prostheses, especially with corresponding normal outflow dimensions, is much better than expected from Doppler gradients. Thus, calculation of a patient/prosthesis mismatch can be misleading.

The MiniACcor: constructive redesign of an implantable total artificial heart, initial laboratory testing and further steps.

The Aachen Total Artificial Heart (ACcor) has been under development at the Helmholtz Institute in Aachen over the last decade. It may serve as a bridge to transplant or as a long-term replacement of the natural heart. Based upon previous in vivo experiments with the ACcor total artificial heart, it was decided to optimize and redesign the pump unit. Smaller dimensions, passive filling and separability into three components were the three main design goals. The new design is called the MiniACcor, which is about 20% smaller than its predecessor, and weighs only 470 grams. Also its external driver/control unit was miniaturized and a new microcontroller was selected. To validate the design, it was extensively tested in laboratory mock loops. The MiniACcor was able to pump between 4.5 and 7 l/min at different pump rates against normal physiological pressures. Several requirements for the future compliance chamber and transcutaneous energy transmission (TET) system were also measured in the same mock loop. Further optimization and validation are being performed in cooperation with the Heart and Diabetes Centre North Rhine-Westphalia.

Impact of pressure recovery in the evaluation of the Omnicarbon tilting disc valve.

BACKGROUND: Pressure recovery is not taken into account when calculating trans-prosthetic gradients after mechanical valve replacement using Doppler echocardiography. This may lead to underestimation of valvular performance. METHODS: Simultaneous measurement of Doppler and direct trans-prosthetic gradients was performed in a circulatory mock loop simulator with physiologic parameters at different heart rates and cardiac outputs for small-sized aortic Omnicarbon tilting disc valves (19 - 21 mm). RESULTS: In all adjustments the Doppler gradient significantly overestimated the net transvalvular gradient. The amount of pressure recovery averaged 59.3 %. CONCLUSIONS: Doppler echocardiography does not allow for pressure recovery, which is a significant phenomenon in the hemodynamic function of the Omnicarbon tilting disc valve. Valve performance is much better than expected from Doppler gradients.

CFD simulation of a novel bileaflet mechanical heart valve prosthesis: an estimation of the Venturi passage formed by the leaflets.

The aim of this study was to validate the flow characteristics of the novel Helmholtz-Institute Aachen Bileaflet (HIA-BL) heart valve prosthesis. The curved leaflets of the HIA-BL valve form a Venturi passage between the leaflets at peak systole. By narrowing the cross section the flow accelerates and the static pressure at the central passage decreases according to the Venturi effect. The low-pressure zone between the leaflets is expected to stabilize the leaflets in fully open position at peak systole. To investigate the Venturi passage, the flow fields of two valve geometries were investigated by CFD (Computational Fluid Dynamics): one geometry exhibits curved leaflets resulting in a Venturi passage; the other geometry features straight leaflets. The flow profiles, pressure distribution and resulting torque of both passages were compared and investigated. Although flow profiles downstream of both valves were similar, the flow passages between the leaflets were different for the investigated leaflet geometries. The straight leaflet passage showed a large boundary layer separation zone near the leaflets and the lowest pressure at the leading edge of the leaflet. The Venturi passage showed a reduction of the boundary layer separation zones and the lowest pressure between the leaflets could be found in the narrowest flow cross section of the Venturi passage. Additionally, the resulting torque showed that the Venturi passage produced an opening momentum. The results demonstrate that the Venturi passage stabilizes the leaflets in open position at peak systole.

Development, manufacturing and validation of a single-leaflet mechanical heart valve prosthesis.

A new single-leaflet mechanical heart valve prosthesis was developed and evaluated in vitro and in vivo. The basic design of the closing body is S-shaped, with the leading and trailing edges parallel to the flow direction. This closing body has an additional cross camber and a fixed axis of rotation. The bearing pins of the disc are guided within oblong through bores of the housing, resulting in a self-cleaning effect. The valve housing has a nozzle-shaped configuration in order to avoid flow separation at the inlet and to reduce the associated pressure loss. Development and optimization studies were carried out by means of upscale valve models. After manufacturing of the closing body from pyrolytic carbon and of the orifice from titanium final hydrodynamic evaluation was carried out according to ISO 5840. The results were comparable or better than for bileaflet valves, the cavitation threshold was above a left ventricular dP/dt of 5500 mmHg/sec. The excellent in vitro results were confirmed by in vivo animal studies in calves and sheep with implantation times of 12 months and six months, respectively. These studies were carried out at the RWTH Aachen and at the NIH, Washington. Without any anticoagulation treatment the valves showed excellent results, confirming the concept of a valve design based on advanced engineering techniques.

In vitro comparison of bileaflet aortic heart valve prostheses. St. Jude Medical, CarboMedics, modified Edwards-Duromedics, and Sorin-Bicarbon valves.

The hydrodynamic performance of four currently used bileaflet heart valve prostheses (St. Jude Medical, CarboMedics, modified Edwards-Duromedics, and Sorin-Bicarbon) with a nominal tissue anulus diameter of 27 mm were measured in the aortic position. All experiments were performed in nonpulsatile flow and in an electrohydraulic, computer-controlled pulse duplicator simulating the left side of the human circulatory system. Testing conditions were set at cardiac outputs of 3.0, 4.5, 6.5, and 8.0 L/min at a constant heart rate of 70 beats/min. The Sorin-Bicarbon valve had the lowest pressure difference with regard to nonpulsatile (mean 5.4 mm Hg at 30 L/min) and pulsatile (mean 2.2 mm Hg at 8 L/min) flow, followed by the St. Jude Medical, CarboMedics, and modified Edwards-Duromedics valves. The leakage volumes under static and pulsatile flow conditions were lowest for the modified Edwards-Duromedics and Sorin-Bicarbon valves. The energy loss in pulsatile flow was lowest for the Sorin-Bicarbon valve, mainly because its systolic, closure, and leakage energy losses were low. Systolic sequential velocity profiles showed the most even flow distribution pattern for the St. Jude Medical and Sorin-Bicarbon valves. These findings correspond with lower overall Reynolds shear stress levels for the St. Jude Medical and the Sorin-Bicarbon valves than for the modified Edwards-Duromedics and CarboMedics valves.

Closing sounds and related complaints after heart valve replacement with St Jude Medical, Duromedics Edwards, Björk-Shiley Monostrut, and Carbomedics prostheses.

OBJECTIVE: To measure the noise produced and related subjective complaints after implantation of four different mechanical heart valve prostheses and to identify further factors related to the patient and prosthesis that influence noise generation and complaints. DESIGN: Sound pressure was measured 5 and 10 cm and 1 m from the point of maximal impulse on the body surface by a calibrated meter in quiet rooms with either a decibel(A) filter or octave filters. The patients were asked about their complaints and examined physically. SETTING: The measurements were conducted in silent rooms of ear, nose, and throat departments. The patients had been operated on either in a university hospital or a community hospital. MAIN OUTCOME MEASURES: Sound pressures of frequency bands and sound pressures measured in dB(A) at various distances. Complaints registerd were: sleep disturbance, disturbance during daytime, "wants a less noisy prosthesis," and "can hear the closing click". PATIENTS: 143 patients after heart valve replacement with St Jude Medical (n = 35), Duromedics Edwards (n = 38), Carbomedics (n = 34) and Björk-Shiley Monostrut (n = 36) prostheses operated on between 1984 and 1988 were matched for valve position, ring size, and body surface area. RESULTS: Duromedics Edwards (33.5 (6) dB(A)) and Björk-Shiley Monostrut valves (31 (4) dB(A)) were significantly louder than St Jude Medical (24 (4) dB(A)) and Carbomedics (25 (6) dB(A)) prostheses (p = 0.0001) (mean (SD)). The louder valves were significantly more often heard by the patients (p = 0.0012) and caused more complaints both during sleep (p = 0.024) and during the daytime (p = 0.07). Patients with these valves were more likely to want a less noisy valve (p = 0.0047). Patients with symptoms were younger, had better hearing, and were more likely to be in sinus rhythm. As well as the type of prostheses, the valve diameter and body height also had an effect on sound emission. CONCLUSIONS: The intensity of the closing click of mechanical valve prostheses was significantly different for various designs. Patient complaints were related to the objectively measured sound pressure. Noise production should be considered when a mechanical valve is selected.

Closing click of St Jude Medical and Duromedics Edwards bileaflet valves: complaints created by valve noise and their relation to sound pressure and hearing level.

The metallic clicking sound created by mechanical heart valve prostheses frequently bothers patients. To test whether sounds generated by different bileaflet valves correlate to complaints related to the prosthetic clicking 73 patients were investigated after valve replacement with Duromedics Edwards (DE) (n = 38) and St Jude Medical (SJM) (n = 35) valves. The patients were asked about their complaints, sound pressure levels were recorded and audiometry was performed. Sixty-five percent of patients could hear their valve, 18% had sleeping disturbances, 5% felt bothered during daytime and 12% would prefer a less noisy valve. In symptomatic patients, sound pressure levels were higher than in asymptomatic patients (valve audible 45 +/- 8 db(A) vs not audible 39.9 +/- 10 db(A) at 10 cm; P = 0.016). These differences were most apparent in the high frequency bands, corresponding to the metallic click. Symptomatic patients had better hearing and were younger than patients without complaints. Fifty-one percent could hear their valve by conduction through the body, after eliminating air conduction by the use of headsets. The DE prostheses were louder than the SJM valves in general (47.4 +/- 7 vs 39.8 +/- 5 db (A) at 10 cm; P = 0.001) and in each valve position. Patients with DE prostheses had significantly more complaints. The intensity of the closing click of mechanical valves correlates to the complaints caused by prosthetic clicking and thus sound emission should be considered when a mechanical heart valve prosthesis is selected.

[Noise origin and noise-induced complaints after heart valve replacement with mechanical prostheses]. / Lärmentwicklung und lärmabhängige Beschwerden nach Herzklappenersatz mit mechanischen Prothesen.

143 patients were investigated in order to determine whether there is a difference in the intensity of the closing click between different mechanical heart valve prostheses. 35 had St. Jude Medical (SJM), 38 Duromedics Edwards (DE), 36 Björk Shiley Monostrut (BSM) and 34 had Carbomedics prostheses implanted. Sound pressure level determined at 1 meter distance was significantly higher for the DE 33.5 +/- 6 dB(A) and BSM 31 +/- 4 dB(A) than for the SJM 24 +/- 4 dB(A) and CM 25 +/- 6 dB(A) prostheses (p = 0.0001). Valves developing higher sound pressures were more frequently audible for the patients (p = 0.0012), caused more sleep disturbances (p = 0.024) and more complaints during daytime (p = 0.07). Significantly more patients carrying such valves wished to have a less noisy valve implanted (0.0047). Symptomatic patients wear louder valves, were younger, had better hearing and were more frequently in sinus rhythm. Valve diameter correlated with the developed sound pressure level. 349 patients answered a questionnaire after valve replacement with DE (256) or BSM (93) prostheses. 5% registered their noise-related complaints as being severe, but more than one third wished to have a less noisy valve implanted. The noise created by the closing click of mechanical prostheses causes significant complaints and this factor should be considered when a mechanical valve is selected.

Noise level and perception of the closing click after heart valve replacement with St. Jude Medical and Björk Shiley Monostrut prostheses.

The metallic click generated by the closure of mechanical heart valve prostheses may severely bother patients, but generated sound energy and the extent of complaints after implantation are not known. In 62 patients, after valve replacement with St. Jude Medical (SJM) (n = 35) and Björk Shiley Monostrut (BSM) (n = 27) prostheses, sound energy was recorded with a calibrated noise level analyzer at 5, 10, and 100 cm distance from patients and correlated with their complaints. At a distance of 100 cm, the BSM valves produced a significantly higher sound pressure level, 30.5 +/- 5 db(A), compared to the SJM valves, 24.1 +/- 4 db(A) (p = 0.0001). There was no significant difference at shorter distances. After splitting into frequency bands the highest sound pressure levels were observed in the high frequency ranges (8 to 16 kHz) representing the metallic click. BSM valves produced higher sound levels in all frequency ranges at 1 m distance. Seventy-three percent of all patients were aware of the noise generated by the valve; 20% had disturbed sleep; and 26% preferred a less noisy valve type. Twelve of 27 patients with BSM valves wanted less noisy valves, whereas only 4 of 35 patients with SJM valves wished to have a less noisy valve type (Chi-square p = 0.003). In patients who could hear their valve measured, sound level was higher than in patients who could not. In 9 of 27 patients with BSM (33%), versus 3 of 35 with SJM prostheses (9%), the clicking caused sleep disturbances.(ABSTRACT TRUNCATED AT 250 WORDS)