Fluid-Structure Interaction and In Vitro Analysis of a Real Bileaflet Mitral Prosthetic Valve to Gain Insight Into Doppler-Silent Thrombosis.

Prosthetic valve thrombosis (PVT) is a serious complication affecting prosthetic heart valves. The transvalvular mean pressure gradient (MPG) derived by Doppler echocardiography is a crucial index to diagnose PVT but may result in false negatives mainly in case of bileaflet mechanical valves (BMVs) in mitral position. This may happen because MPG estimation relies on simplifying assumptions on the transvalvular fluid dynamics or because Doppler examination is manual and operator dependent. A deeper understanding of these issues may allow for improving PVT diagnosis and management. To this aim, we used in vitro and fluid-structure interaction (FSI) modeling to simulate the function of a real mitral BMV in different configurations: normally functioning and stenotic with symmetric and completely asymmetric leaflet opening, respectively. In each condition, the MPG was measured in vitro, computed directly from FSI simulations and derived from the corresponding velocity field through a Doppler-like postprocessing approach. Following verification versus in vitro data, MPG computational data were analyzed to test their dependency on the severity of fluid-dynamic derangements and on the measurement site. Computed MPG clearly discriminated between normally functioning and stenotic configurations. They did not depend markedly on the site of measurement, yet differences below 3 mmHg were found between MPG values at the central and lateral orifices of the BMV. This evidence suggests a mild uncertainty of the Doppler-based evaluation of the MPG due to probe positioning, which yet may lead to false negatives when analyzing subjects with almost normal MPG.

Opening/closing pattern of Trifecta and Freestyle valves versus native aortic valve: Are stentless valves more physiologic than a stented valve?

BACKGROUND: Stentless valves have long been considered the ideal valves in terms of hemodynamics. Recently, the Trifecta valve, a stented bioprosthesis with excellent fluid dynamic characteristics, has become available. The aim of the study was to compare the opening/closing pattern of the Freestyle stentless valve and the Trifecta valve with that of the native aortic valve. METHODS: A total of 12 patients with a Freestyle and 10 with a Trifecta valve were compared to normal native aortic valves in 12 control patients. Leaflet kinematics and hemodynamic parameters were obtained by echocardiographic M-mode and Doppler measurements. RESULTS: The control group displayed significantly longer Rapid Valve Opening Time (45 ± 7 ms) and Rapid Valve Closing Time (42 ± 9 ms) than Freestyle patients (Rapid Valve Opening Time: 32 ± 7 ms; Rapid Valve Closing Time: 31 ± 8 ms) and Trifecta patients (Rapid Valve Opening Time: 31 ± 7 ms; Rapid Valve Closing Time: 30 ± 8 ms) (P < 0.0001). The maximal leaflet displacement reached at the end of rapid valve opening was 16.7 ± 3.2 mm, 17.7 ± 2.3 mm, and 17.7 ± 5.3 mm (P = 0.42) in the Freestyle, Trifecta, and control groups, respectively. The total opening time was shorter in the control group (223 ± 25 ms) than in Freestyle (319 ± 61 ms) and Trifecta (324 ± 46 ms) patients (P < 0.0001). CONCLUSIONS: The Freestyle stentless valve was not superior to the Trifecta valve in terms of kinematics and functions more like a stented bioprosthesis.

Opening-closing pattern of four pericardial prostheses: results from an in vitro study of leaflet kinematics.

Pericardial and porcine stented aortic valves have different leaflet kinematics. To study the biomechanics of a prosthesis thoroughly, the in vitro setting is the most appropriate. The aim of our study was to find out whether the prosthesis design in which the pericardial sheet is outside the stent post might influence the opening and closing patterns of the leaflets. Four pericardial prostheses (Magna Ease [MG] 21, Trifecta [TRI] 21, Soprano-Armonia [SA] 20 and Mitroflow [MF] 23) that fitted aortic roots with a native annulus diameter of 2.1 cm were implanted and their leaflet kinematics was studied by a high-speed digital camera. In the opening phase, MG showed the shortest RVOT and the highest RVOVI, with values of 12 ± 2 and 209 ± 17 ms, respectively. The RVOT of MG was significantly shorter than that of MF (p < 0.01), but not than that of TRI (p = 0.286). Both TRI and SA showed similar opening patterns (TRI: RVOT of 15 ± 3 ms and RVOVI of 132 ± 25 ms; SA: 17 ± 2 ms and 126 ± 19 ms), without statistically significant difference. Conversely, MF showed the slowest profile, with an RVOT of 23 ± 3 ms and an RVOVI of 94 ± 8 ms (Table 1; Fig. 3). The opening/closing profile is not influenced by the position of the pericardial leaflets, but depends on other intrinsic structural characteristics related to the material used for the stent and leaflets. Moreover, the kinematics does not affect the valve performance. Table 1 Kinematics and hydrodynamic results, reported as means and standard deviations, evaluated over the tested heart samples TRI SA MG MF ANOVA TRI versus SA TRI versus MG TRI versus MF SA versus MG SA versus MF MG versus MF p Value p Value p Value p Value p Value p Value p Value ET (ms) 1.0 1.0 1.0 1.0 RVOT (ms) 15 ± 3 17 ± 2 12 ± 2 23 ± 3 <0.01 1.0 0.286 <0.01 0.03 <0.01 <0.01 SVCT (ms) 247 ± 14 231 ± 15 256 ± 26 241 ± 11 0.170 0.463 0.853 0.931 0.213 1.0 1.0 RVCT (ms) 35 ± 19 52 ± 13 32 ± 17 52 ± 4 0.07 0.474 1.0 0.494 0.236 1.0 0.247 TVCT (ms) 283 ± 10 283 ± 19 289 ± 10 293 ± 11 0.584 1.00 1.0 1.0 1.0 1.0 1.0 RVOVI (ms-1) 132 ± 25 126 ± 19 209 ± 17 94 ± 8 <0.01 0.959 <0.01 0.02 <0.01 0.07 <0.01 SVCVI (ms-1) -0.9 ± 0.3 -1.1 ± 0.4 -0.57 ± 0.1 -0.55 ± 0.1 <0.01 1.0 0.353 0.292 0.045 0.04 1.0 RVCVI (ms-1) -16 ± 4 -10 ± 2 -18 ± 6 -10 ± 1 <0.01 0.396 1.0 0.513 0.025 1.0 0.03 Δp (mmHg) 6.7 ± 3.6 10.6 ± 5.5 15.2 ± 7.9 10.7 ± 6.1 <0.01 0.01 <0.01 0.01 0.04 1.0 <0.01 EOA (cm2) 2.2 ± 1.2 1.7 ± 0.9 1.5 ± 0.8 1.7 ± 0.9 <0.01 0.03 <0.01 0.01 0.261 0.617 0.11 El  % 7.3 ± 1 11.9 ± 1 15.4 ± 2 11.8 ± 3 <0.01 <0.01 <0.01 <0.01 0.04 1.00 0.03 CO (L/min) 3.1 ± 0.4 2.8 ± 0.5 3.1 ± 0.3 3.0 ± 0.5 0.534 0.282 0.792 0.702 0.106 0.552 0.559 ET ejection time, RVOT rapid valve-opening time, SVCT slow valve-closing time, RVCT rapid valve-closing time, TVCT total valve-closing time, RVOVI rapid valve-opening velocity index, SVCVI slow valve-closing velocity index, RVCVI rapid valve-closing velocity index, Δp mean pressure drop, EOA effective orifice area, El % energy loss, CO cardiac output.

A Comprehensive Fluid Dynamic and Geometric Study for an "In-Vitro" Comparison of Four Surgically Implanted Pericardial Stented Valves.

BACKGROUND AND AIM OF THE STUDY: Many variables may affect the fluid dynamic of an implanted bioprosthesis. In-vitro studies have provided accurate data such that, when different prostheses are implanted in the same true aortic root, it should be possible to make a fair comparison. The study aim was to evaluate the fluid dynamic and geometric characteristics of the four most widely used stented pericardial bioprostheses. METHODS: Four types of pericardial prosthesis (Magna Ease 21, Trifecta 21, Soprano-Armonia 20, and Mitroflow 23) that fitted eight aortic roots with a native annulus diameter of 2.1 cm were implanted and tested in a mock loop. RESULTS: Energy loss and mean gradients were increased with stroke volume (SV) in all valves tested. The effective orifice area values were fairly stable across the SV intervals (p = 0.57). All hemodynamic-related indices displayed mutually consistent behaviors, with Trifecta showing the lowest hindrance to flow. Both geometric orifice area (GOA) and edge geometric orifice area (eGOA) were increased significantly as the SV increased; the Trifecta valve showed the largest eGOA value, while the Trifecta and Mitroflow provided the largest GOAs. For the Trifecta and Soprano-Armonia prostheses (and the Magna to a lesser extent), the most distal cross-section was systematically greater than the inflow area, suggesting a divergent configuration at the systolic peak. CONCLUSION: The study results combined the fluid dynamic reproducibility of the in-vitro setting and the specificity of surgery. A quantitative comparison of the fluid dynamic performance of the different bioprostheses was feasible.

In-vitro study of a porcine quadricuspid aortic valve.

BACKGROUND AND AIM OF THE STUDY: Quadricuspid aortic valve (QAV) is an extremely rare congenital defect in which the valve features an additional fourth cusp. It is often associated with an alteration in valve functionality such as valve regurgitation, stenosis and coronary disease. These associated pathologies entail surgical correction in about 50% of patients at a mean age of 50 years. METHODS: A swine QAV was studied in a pulsatile mock loop in the laboratory. Rest (70 bpm) and exercise (100 bpm) conditions were simulated, and opening and closing kinematics were evaluated from a high-speed video. Short- and long-axis echocardiograms were recorded. The pressure drop across the valve, valve competence and effective orifice area were evaluated and compared to data from healthy samples tested in the same experimental apparatus. RESULTS: Hemodynamic quantities were physiologic-like, despite the QAV showing an altered kinematics (longer closing and opening times compared to healthy samples) and an asynchronous closing phase (the extra cusps reached the closed configuration at the end of systole systematically earlier with respect to the other three cusps). Echocardiographic data showed an increased coaptation height between the left and right coronary cusps, and a mismatch between the lunule of the extra cusp and the non-coronary cusp. CONCLUSION: The altered kinematics, together with incorrect coaptation, can alter the biomechanics of the structure, inducing an anomalous distribution of local stress which could lead to structural failure over time.

Aortic interleaflet triangles reshaping: hydrodynamic, kinematic and morphological effects in in-vitro analysis.

BACKGROUND AND AIM OF THE STUDY: Subcommissural triangles reshaping is a reparative technique used to remodel the ventriculo-aortic junction. The study aim was to evaluate, by means of in-vitro testing, the effects of this technique on hemodynamics, leaflet kinematics and aortic root functional unit morphology. METHODS: Twenty-one porcine aortic roots were tested in a pulsatile mock loop under basal conditions and after subcommissural triangles reshaping performed at 50% of the interleaflet triangles height. During each test, hydrodynamic quantities, high-speed digital videos and echocardiographic images were recorded. RESULTS: The comparison between pre- and post-surgery data showed a statistically significant increase in coaptation height (p < 0.01) and length (p < 0.01). Significant reductions were found in the virtual basal ring diameter (p < 0.01), sinus of Valsalva diameters (p < 0.01), maximum leaflet opening (p < 0.01), leaflet opening before rapid valve closing time (p < 0.01) and maximum opening area (p < 0.01). An opened valve time reduction (p <0.01) was observed due to an opening time reduction (p < 0.01), offset by a closed valve time increase (p < 0.01). A slow closing period increase (p < 0.07) and a rapid closing phase reduction (p < 0.01), were also highlighted without influence on the total closing time. A statistical, but not clinically significant, increase in pressure drop across the valve (p < 0.01) and an effective orifice area reduction (p < 0.01) were observed. CONCLUSION: Subcommissural triangles reshaping performed at 50% of the interleaflet triangles' height determines an increase in leaflet coaptation by remodeling the ventriculo-aortic junction. Some hydrodynamic and kinematic changes also occur, without any acute clinically threatening alterations.

A Novel Transcatheter Device for the Edge-to-Edge Treatment of Tricuspid Regurgitation: A Preliminary Evaluation.

Tricuspid regurgitation (TR) is the most common pathology of the tricuspid valve (TV), with significant mortality in severe cases. A well-established strategy to treat TR is represented by the clover surgical technique, which consists of stitching together the free edges of TV leaflets, producing a clover-shaped valvular orifice. Transcatheter treatments for TR constitute a valuable alternative for high-risk patients. In this work we investigated haemodynamic performances and safety of a novel device (StarTric device (STD)) aiming to perform the clover technique via percutaneous access. To assess haemodynamic performances, STD and clover were applied on porcine pathological TVs and tested. Fluid dynamic indexes of both strategies were compared to the pathological model. To evaluate device safety, forces exchanged between device and leaflets were compared to the extraction force (EF) required to STD to completely pass through the leaflet. Clover technique and STD induced a comparable TV backflow reduction (48% and 47%, respectively), with associated increase of TV flow in all tested conditions. Diastolic transvalvular pressure similarly increased indicating a reduction, though not significant, of the valvular orifice. Forces ranged from 1N to 1.71N, compared to an EF of 22.16 ± 8.6N. Force varied significantly amongst different working conditions (normotensive, mild, and severe hypertensive) for each leaflet, whilst no significative variation was found on different leaflets in the same working condition. In the adopted experimental scenario, STD demonstrated comparable efficacy to the surgical strategy in restoring TV haemodynamic. The forces acting on the leaflets following STD implantation were far lower when compared to EFs.

Morphometric Characterization of an Ex Vivo Porcine Model of Functional Tricuspid Regurgitation.

Emerging treatments for tricuspid valve (TV) regurgitation require realistic TV pathological models for preclinical testing. The aim of this work was to investigate structural features of fresh and defrosted porcine right-heart samples as models of mild and severe functional tricuspid regurgitation (FTR) condition in ex-vivo pulsatile flow platform. Ten fresh hearts were tested ex-vivo under steady and pulsatile flow in typical right-heart loading conditions. Hemodynamics and 3D echocardiographic imaging of TV and right ventricle (RV) were acquired. Hearts were then kept frozen for 14 days, defrosted, and tested again with the same protocol. Morphometric parameters of TV and RV were derived from 3D reconstructions based on echo data. Fresh samples showed a slightly dilated TV morphology, with coaptation gaps among the leaflets. Sample freezing induced worsening of TV insufficiency, with significant (p < 0.05) increases in annulus size (annulus area and perimeter 7.7-3.1% respectively) and dilation of RV (9.5%), which led to an increase in tenting volume (123.7%). These morphologic alterations reflected into a significant increment of regurgitation fraction (27%). Together, such results suggest that fresh porcine heart samples may be a reliable ex-vivo model of mild FTR condition, which can be enhanced through freezing/thawing treatment to model a severe pathological condition.

Coronary Perfusion After Valve-in-Valve Transcatheter Aortic Valve Implantation in Small Aortic Root: In Vitro Experimental Assessment.

Coronary flow obstruction following transcatheter aortic valve-in-valve implantation (VIV-TAVI) is associated with a high mortality risk. The aim of this work was to quantify the coronary perfusion after VIV-TAVI in a high-risk aortic root anatomy. 3D printed models of small aortic root were used to simulate the implantation of a TAVI prosthesis (Portico 23) into surgical prostheses (Trifecta 19 and 21). The aortic root models were tested in a pulsatile in vitro bench setup with a coronary perfusion simulator. The tests were performed at baseline and post-VIV-TAVI procedure in aligned and misaligned commissural configurations under simulated hemodynamic rest and exercise conditions. The experimental design provided highly controllable and repeatable flow and pressure conditions. The left and right coronary mean flow did not differ significantly at pre- and post-VIV-TAVI procedure in any tested configurations. The commissural misalignment did not induce any significant alterations to the coronary flow. High-risk aortic root anatomy did not trigger coronary ostia obstruction or coronary flow alteration after transcatheter aortic valve implantation in a surgical bioprosthesis as shown from in-vitro flow loop tests.

In vitro four-dimensional flow magnetic resonance analysis of the effect of pericardial valve design on aortic flow.

We investigated the effect of the design of bioprosthetic pericardial valves on the downstream fluid flow pattern through four-dimensional flow magnetic resonance imaging (4D Flow). A dedicated in vitro test bench, including a paradigmatic aortic root phantom, was used to compare, under steady flow conditions, three commercially used pericardial bioprostheses (TrifectaTM, Carpentier-Edwards PERIMOUNT Magna, Crown PRT®), selecting the two smallest and comparable valve sizes. In-house 4D Flow post-processing provided the downstream flow pattern of velocity, the velocity profile at vena contracta, its effective orifice area (EOA) and the corresponding hydraulic diameter (DH). Trifecta reported the lowest peak of velocity for both the tested sizes, with vena contracta position being the most proximal to the free margin of leaflets. Conversely, in both Crown and Magna, jet flow continued to increase its downstream velocity, resulting in a farther position of vena contracta. EOA shape was trilobal for Magna, triangular for Crown and circular for Trifecta, the last one maximising EOA. The percentage of nominal luminal area effectively exploited by the flow was largely above 80% in Trifecta, below 75% in Crown and below 70% in Magna. Hence, the design of pericardial bioprostheses directly impacts on the downstream flow field pattern and its fluid dynamic performance.

Commissural repositioning in bicuspid aortic valve repair: an in vitro acute model to explore and explain different results.

OBJECTIVES: Commissural orientation <160° is a recognized risk factor for bicuspid aortic valve repair failure. Based on this observation, repairing this subtype of aortic valve by reorienting the 2 commissures at 180° has recently been proposed. METHODS: Nine porcine hearts with aortic annulus diameters of 25 mm were selected. A pathological model of a Sievers 1 bicuspid aortic valve was obtained by suturing the coaptation line between the left and right leaflets. Each heart underwent reimplantation procedures both in the native (120°) and the reoriented (180°) configuration. After the operation, each sample was tested on a pulse duplicator at rest (heart rate 60 beats per min) and with mild exercise (heart rate 90 beats per min) conditions. RESULTS: No statistically significant difference was noted in mean and peak transvalvular aortic gradients between the 2 configurations at rest (18.6 ± 5 vs 17.5 ± 4 for the mean aortic gradient; 42.8 ± 12.7 vs 36.3 ± 5.8 for the peak aortic gradient) but the group with the 120°-oriented commissures had significantly higher mean transaortic gradients compared to the group with the 180°-oriented commissures at initial exercise stress conditions (30.1 ± 9.1 vs 24.9 ± 3.8; p value 0.002). CONCLUSIONS: The 180° commissural reorientation of the asymmetrical bicuspid aortic valve does not improve the transvalvular aortic gradient in an acute model at rest conditions, but it could do so under stress situations. Even if it is surgically more complex and time-consuming, this approach could be a good strategy to improve long-term results, particularly in young patients.

Development and Validation of a Novel Skills Training Model for PCNL, an ESUT project.

BACKGROUND AND AIM: The aim of this study is to validate a totally non biologic training model that combines the use of ultrasound and X ray to train Urologists and Residents in Urology in PerCutaneous NephroLithotripsy (PCNL). METHODS: The training pathway was divided into three modules: Module 1, related to the acquisition of basic UltraSound (US) skill on the kidney; Module 2, consisting of correct Nephrostomy placement; and Module 3, in which a complete PCNL was performed on the model. Trainees practiced on the model first on Module 1, than in 2 and in 3. The pathway was repeated at least three times. Afterward, they rated the performance of the model and the improvement gained using a global rating score questionnaire. RESULTS: A total of 150 Urologists took part in this study. Questionnaire outcomes on this training model showed a mean 4.21 (range 1-5) of positive outcome overall. Individual constructive validity showed statistical significance between the first and the last time that trainees practiced on the PCNL model among the three different modules. Statistical significance was also found between residents, fellows and experts scores. Trainees increased their skills during the training modules. CONCLUSION: This PCNL training model allows for the acquisition of technical knowledge and skills as US basic skill, Nephrostomy placement and entire PCNL procedure. Its structured use could allow a better and safer training pathway to increase the skill in performing a PCNL.

Leaflet kinematics after the Yacoub and Florida-sleeve operations: results of an in vitro study.

OBJECTIVES: The Florida-sleeve is a valve-sparing technique that causes minimal interference to leaflet kinematics and aortic root dynamism. The aim of this in vitro study was to evaluate the effects of the Florida-sleeve and Yacoub techniques on aortic leaflet kinematics. METHODS: Two groups of 6 whole porcine hearts were treated with either the Florida-sleeve technique or the Yacoub technique and tested in a pulsatile loop. Valve fluid dynamics, coronary flow analysis and valve echocardiograms were performed both before and after the procedures. RESULTS: Both procedures showed no difference in rapid valve opening time as compared with their respective baseline values. The Florida-sleeve procedure showed a shorter slow closing time (192 ± 19 ms vs baseline 244 ± 14 ms, P = 0.016) and increased slow closing velocity (-1.5 ± 0.4 cm/s vs baseline -0.8 ± 0.4 cm/s, P = 0.038). In the rapid valve closing phase, the Yacoub procedure showed a trend towards slower closing valve velocity (-16 ± 9 cm/s vs baseline -25 ± 9 cm/s, P = 0.07). The Yacoub procedure showed larger leaflet displacement at the end of the slow valve closing time that was 2.0 ± 0.5 cm vs baseline 1.5 ± 0.3 cm, P = 0.044. When comparing the Florida-sleeve and Yacoub procedures, the former showed statistically significant shorter slow valve closing time (P = 0.017). CONCLUSIONS: This study showed that the Florida-sleeve technique alters the slow closing phase of the aortic valve leaflet kinematics when compared with both the normal baseline and Yacoub procedure, while the latter showed a larger leaflet displacement before the rapid closing valve phase.

Ex Vivo Model of Functional Mitral Regurgitation Using Deer Hearts.

Transcatheter therapies are emerging for functional mitral regurgitation (FMR) treatment, however there is lack of pathological models for their preclinical assessment. We investigated the applicability of deer hearts for this purpose.8 whole deer hearts were housed in a pulsatile flow bench. At baseline, all mitral valves featured normal coaptation. The pathological state was induced by 60-minutes intraventricular constant pressurization. It caused mitral annulus dilation (antero-posterior diameter increase from 31.8 ± 5.6 mm to 39.5 ± 4.9 mm, p = 0.001), leaflets tethering (maximal tenting height increase from 7.3 ± 2.5 mm to 12.7 ± 3.4 mm, p < 0.001) and left ventricular diameter increase (from 67.8 ± 7.5 mm to 79.4 ± 6.5 mm, p = 0.004). These geometrical reconfigurations led to restricted mitral valve leaflets motion and leaflet coaptation loss. Preliminary feasibility assessment of two FMR treatments was performed in the developed model.Deer hearts showed ability to dilate under constant pressurization and have potential to be used for realistic preclinical research of novel FMR therapies. Graphical abstract figure legend: Deer heart mitral valve fiberscopic and echocardiographic images in peak systole at baseline and after inducing the pathological conditions representing functional mitral regurgitation. In the pathological conditions lack of coaptation between the leaflets, enlargement of the antero-posterior distance (red dashed line) and the left ventricular diameter (orange dashed line) were observed.

Effect of the valve design on pressure drop, pressure recovery, and spatial positioning of vena contracta.

BACKGROUND: Bioprostheses are complex structures and yield a very complex fluid dynamics. Hence, it can be hypothesized that prosthesis structural characteristics affect the position of the vena contracta and, consequently, influences the pattern and the extent of pressure recovery downstream from the vena contracta. MATERIALS AND METHODS: The study was performed on pericardial aortic prostheses, specifically Crown 21 and 23 (LivaNova PLC, UK), Trifecta 19 and 21 (Edwards Lifescience, USA), and Magna 19 and 21(Abbott, USA), tested in an "ad hoc" devised steady flow loop circuit at four flow rates (10, 15, 20, and 25 L/min). Fluid dynamic quantities were obtained by direct pressure measurement and Doppler interrogation. RESULTS: Pressure drop at 25 L/min flow rate was 26.5 ± 0.3 mm Hg and 14.9 ± 0.1 mm Hg for the Trifecta 19 and 21, 37.1 ± 1.0 mm Hg and 27.3 ± 0.4 mm Hg for the Magna 19 and 21, and 36.6 ± 1.0 mm Hg and 22.7 ± 0.1 mm Hg for Crown 21 and 23, respectively. The vena contracta was shorter for Trifecta compared with the Magna and the Crown in which it developed further downstream and as far as 1 cm from the valve leaflets fringes. The pressure recovery was 54% ± 1% for Trifecta 21, 39% ± 1% for Magna 21, and 41% ± 2% for Crown 23 with different patterns. CONCLUSION: The design of bioprosthesis affects pressure recovery and the position of the vena contracta. The different patterns of pressure recovery might have clinical impact.

4D Flow MRI hemodynamic benchmarking of surgical bioprosthetic valves.

PURPOSE: We exploited 4-dimensional flow magnetic resonance imaging (4D Flow), combined with a standardized in vitro setting, to establish a comprehensive benchmark for the systematic hemodynamic comparison of surgical aortic bioprosthetic valves (BPVs). MATERIALS AND METHODS: 4D Flow analysis was performed on two small sizes of three commercialized pericardial BPVs (Trifecta™ GT, Carpentier-Edwards PERIMOUNT Magna and Crown PRT®). Each BPV was tested over a clinically pertinent range of continuous flow rates within an in vitro MRI-compatible system, equipped with pressure transducers. In-house 4D Flow post-processing of the post-valvular velocity field included the quantification of BPV effective orifice area (EOA), transvalvular pressure gradients (TPG), kinetic energy and viscous energy dissipation. RESULTS: The 4D Flow technique effectively captured the 3-dimensional flow pattern of each device. Trifecta exhibited the lowest range of velocity and kinetic energy, maximized EOA (p < 0.0001) and minimized TPGs (p ≤ 0.015) if compared with Magna and Crown, these reporting minor EOA difference s (p ≥ 0.042) and similar TPGs (p ≥ 0.25). 4D Flow TPGs estimations strongly correlated against ground-truth data from pressure transducers; viscous energy dissipation proved to be inversely proportional to the fluid jet penetration. CONCLUSION: The proposed 4D Flow analysis pinpointed consistent hemodynamic differences among BPVs, highlighting the not negligible effect of device size on the fluidynamic outcomes. The efficacy of non-invasive 4D Flow MRI protocol could shed light on how standardize the comparison among devices in relation to their actual hemodynamic performances and improve current criteria for their selection.

A new pulsatile volumetric device with biomorphic valves for the in vitro study of the cardiovascular system.

A pulsatile mock loop system was designed and tested. This prototype represents a versatile, adjustable, and controllable experimental apparatus for in vitro studies of devices meant to interface with the human circulatory system. The pumping system consisted of a ventricular chamber featuring two biomorphic silicone valves as the inlet and outlet valves. The chamber volume is forced by a piston pump moved by a computer-controlled, low-inertia motor. Fluid dynamic tests with the device were performed to simulate physiological conditions in terms of cardiac output (mean flow of 5 and 6 L/min, with beat rates from 60 to 80 bpm), of rheological properties of the processed fluid, and of systemic circulation impedance. The pulsating actuator performed a good replication of the physiological ventricular behavior and was able to guarantee easy control of the waveform parameters. Experimental pressure and flow tracings reliably simulated the physiological profiles, and no hemolytic subatmospheric pressures were revealed. The performance of the prototype valves was also studied in terms of dynamic and static backflow, effective orifice area, and pressure loss, resulting in their applicability for this device. Mechanical reliability was also tested over 8 h. The device proved to be a reliable lab apparatus for in vitro tests; the pumping system also represents a first step toward a possible future application of pulsating perfusion in the clinic arena, such as in short-term cardiac assist and pulsatile cardiopulmonary bypass.

Experimental setup to evaluate the performance of percutaneous pulmonary valved stent in different outflow tract morphologies.

Percutaneous pulmonary valve implantation is a potential treatment for right ventricular outflow tract (RVOT) dysfunction. However, RVOT implantation site varies among subjects and the success of the procedure depends on RVOT morphology selection. The aim of this study was to use in vitro testing to establish percutaneous valve competency in different previously defined RVOT morphologies. Five simplified RVOT geometries (stenotic, enlarged, straight, convergent, and divergent) were manufactured by silicone dipping. A mock bench was developed to test the percutaneous valve in the five different RVOTs. The bench consists of a volumetric pulsatile pump and of a hydraulic afterload. The pump is made of a piston driven by a low inertia programmable motor. The hydraulic afterload mimics the pulmonary input impedance and its design is based on a three element model of the pulmonary circulation. The mock bench can replicate different physiological and pathological hemodynamic conditions of the pulmonary circulation. The mock bench is here used to test the five RVOTs under physiological-like conditions: stroke volume range 40-70 mL, frequency range 60-80 bpm. The valved stent was implanted into the five different RVOT geometries. Pressures upstream and downstream of the valved stent were monitored. Flow rates were measured with and without the valved stent in the five mock RVOTs, and regurgitant fraction compared between the different valved stent RVOTs. The percutaneous valved stent drastically reduced regurgitant flow if compared with the RVOT without the valve. RVOT geometry did not significantly influence the flow rate curves. Mean regurgitant fractions varied from 5% in the stenotic RVOT to 7.3% in the straight RVOT, highlighting the influence of the RVOT geometry on valve competency. The mock bench presented in this study showed the ability to investigate the influence of RVOT geometry on the competence of valved stent used for percutaneous pulmonary valve treatment.

Hydrodynamic and Geometric Behavior of Two Pericardial Prostheses Implanted in Small Aortic Roots.

Hydrodynamic performance of stented bioprostheses is far below that of the native valve. One of the reasons is that the internal diameter of the prosthesis is usually smaller than that of the native valve. However, other valve characteristics are also important in generating the pressure drop. We aimed to assess, in an ex vivo pulsatile mock loop, the hydrodynamic behavior of two bioprostheses, Trifecta and Mitroflow, to ascertain which geometric terms are limiting factors in hydrodynamic performance. At stroke volumes between 30 and 60 ml, Trifecta showed lower pressure drop, energy dissipation and valve resistance, and greater effective orifice area. This trend was overturned at higher stroke volumes, with Mitroflow slightly outperforming Trifecta. The geometric determinants were consistent with these results. Trifecta achieved its maximum opening area already at the lowest stroke volumes, featuring a divergent shape at the systolic peak. Mitroflow showed a complex opening pattern, featuring a convergent shape at the systolic peak for lower stroke volumes, while reaching its maximum opening area at higher stroke volumes, with a divergent shape. The two bioprostheses, although similar in design, displayed different biomechanical behaviors. The internal diameter of each bioprosthesis did not show to be strictly correlated with its hydrodynamic characteristics.