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Baylous K, Kovarovic B, Anam S, Helbock R, Slepian M, Bluestein D. ArXiv [Preprint].
Prosthetic heart valve interventions such as TAVR have surged over the past decade, but the associated complication of long-term, life-threatening thrombotic events continues to undermine patient outcomes. The hydrodynamic testing of a 29-mm CoreValve was conducted using a pulse duplicator system (Left Heart Simulator, ViVitro Labs, Victoria, BC). Post-TAVR deployment hemodynamics in patient-specific bicuspid aortic valve anatomies revealed varying degrees of thrombogenic risk for these patients, despite being clinically defined as “mild” paravalvular leak.
Other Products Cited: Analysis and Computational Modeling Flow Visualization Heart Valve Testing
Visit SourceBreitenstein-Attach, A., Steitz, M., Sun, X. et al. Ann Biomed Eng (2024).
With about 100,000 children in need of a new pulmonary valve each year worldwide, this study evaluates geometrical approaches in adult as well as pediatric size and condition. A commercially available pulse duplicator (ViVitro Labs Inc., Victoria/Canada) was used for in vitro assessment. For both the adult and the pediatric prostheses, valves with the closed geometry had significantly reduced tightness with more inhomogeneity and pinwheeling compared to the semi-closed valves.
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Visit SourceJ. Kiekenap MD, X. Sun MD, Y. Hao MD, M. Steitz M.Sc., A. Breitenstein-Attach M.Sc., J. Emeis B.A.Sc., F. Berger MD, PhD, B. Schmitt MD, PhD, Catheterization and Cardiovascular Interventions, Volume 103, Issue 4
Current heart valve implants entail major disadvantages in the treatment for younger patients or those with congenital heart defects. In vitro testing was performed in a Pulse Duplicator by the Canadian company ViVitro Labs Inc. equipped with flow and pressure sensors that is certified according to ISO-standard 5840 simulating conditions in the human heart. In vitro tests in a pulse duplicator showed compliance with regulatory requirements in terms of valve opening and insufficiency.
Other Products Cited: Heart Valve Testing Tissue Engineering
Visit SourceS. F. Melo, A. Nondonfaz, A. Aqil, A. Pierrard, A. Hulin, C. Delierneux, B. Ditkowski, M. Gustin, M. Legrand, B. M. E. Tullemans, S. L. N. Brouns, A. Nchimi, R. Carrus, A. Dejosé, J. W. M. Heemskerk, M. J. E. Kuijpers, J. Ritter, U. Steinseifer, J. C. Clauser, C. Jérôme, P. Lancellotti, and C. Oury, Biomater. Sci., 2024
Valve replacement with prosthetic heart valves has shown to substantially improve survival in patients, and is currently considered the effective treatment for aortic valve disease. Manufactured tri-leaflet NIPU valves with an internal diameter of 19 mm were placed in the aortic valve position of a left heart model (pulse duplicator equipment, from ViVitro labs). Testing of the NIPU valves in a pulse duplicator showed good hydrodynamic performance.
Other Products Cited: Analysis and Computational Modeling Heart Valve Testing HiCycle Durability Tester
Visit SourceMeskin, M., Starkey, P.A., Kaspersen, A.E. et al. Sci Rep 14, 1864 (2024).
To understand the mechanisms and to assess the performance of cardiac devices and interventions, in vitro models can be used to replicate the complex physiological interplay between the pulmonary veins, left atrium, and left ventricle. It includes a pulsatile electromechanical pump (SuperPump AR Series, ViVitro Labs, Victoria, British Columbia, Canada) that provides the volume changes in the rigid LV chamber during the cardiac cycle. This study presents a new versatile left heart MCL that accurately captures the complex and interrelated sequences of left heart events and provides supplementary understanding of left heart fluid dynamics.
Other Products Cited: Ex ViVo Simulation Heart Valve Testing Pulsatile Flow Simulation SuperPump
Visit SourceSpanjaards, M., Borowski, F., Supp, L. et al. Biomech Model Mechanobiol (2024).
A workflow to perform fast preoperative risk assessment of paravalvular leakage (PVL) after transcatheter aortic valve replacement (TAVR) is presented in this paper. Physiological pressure and flow conditions in the aortic root are generated using a commercial pulse duplicator system from ViVitro Labs Inc. (Victoria, Canada). This model can be used to calculate the regurgitant volume after TAVR at reduced cost.
Other Products Cited: Analysis and Computational Modeling Heart Valve Testing
Visit SourceKarl, R., Romano, G., Marx, J. et al. Int J CARS (2023)
Minimally invasive mitral valve surgery (MIMVS) and transcatheter edge-to-edge repair (TEER) are complex procedures used to treat mitral valve (MV) pathologies, but with limited training opportunities available. The SuperPump, a pulsatile cardiac piston pump in combination with a viscoelastic impedance adapter (both ViVitro Labs, Inc., BC, Canada), is attached to the LV and produces preselected and customizable waveforms at various frequencies and amplitudes. Ex-vivo modelling of MV pathologies and repair procedures using the described simulator realistically replicated physiological in-vivo conditions.
Other Products Cited: Heart Valve Repair
Visit SourceMasheane, L., du Preez, W., & Combrinck, J. The South African Journal of Industrial Engineering, 34(4), 104–115
To design cost-effective polyurethane heart valves, comprehend haemodynamic behaviour, expedite prototype development, and reduce the need for clinical testing for functional evaluation, the implementation of an experimental test digital twinning is essential. A ViVitro CPD (ViVitro Labs Inc., British Columbia, Canada) system, combined with the ViVitest data acquisition system, was used for pulse duplication at the Robert WM Frater Cardiovascular Research Centre at the University of the Free State in Bloemfontein, South Africa. The application of pulse duplicator digital twinning enabled a rapid evaluation of the valve’s functionality and a determination of the degree of its efficacy in specified environments at a minimal cost.
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Visit SourceZhang, X., Kizilski, S.B., Recco, D.P. et al. Cardiovasc Eng Tech 14, 827–839 (2023).
Pulmonary valve (PV) monocusp reconstruction in transannular patch (TAP) right ventricular outflow tract (RVOT) repair for Tetralogy of Fallot has variable clinical outcomes across different surgical approaches. The ViVitro Pulse Duplicator System (ViVitro Labs Inc., Victoria, BC) was used to simulate infant RVOT physiological pulsatile flow. Balancing pressure gradient, regurgitation, and oversizing for growth, a set of leaflet design parameters have been selected for pre-clinical evaluation.
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Visit SourceViktória Stanová, Régis Rieu, Lionel Thollon, Erwan Salaun, Josep Rodés-Cabau, Nancy Côté, Diego Mantovani, Philippe Pibarot
Aortic valve stenosis is the third most frequent cardiovascular disease in high-income countries after hypertension and coronary artery disease and is associated with increased risk of heart failure and mortality. Contraction of the left ventricle and left atrium were obtained using two ViVitro piston pumps (ViVitro Inc, Victoria, Canada). The results of this in vitro/in silico study suggest that newer generations of THVs have ∼30% lower leaflet mechanical stress than the early generations.
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Visit SourceGavin A. D'Souza, Jean E. Rinaldi, Moustafa Meki, Annabelle Crusan, Eric Richardson, Meir Shinnar, Luke H. Herbertson, J Biomech Eng. Jan 2024, 146(1): 011004 (11 pages)
Mechanical circulatory support (MCS) device therapy is one of the primary treatment options for end-stage heart failure (HF), whereby a mechanical pump is integrated with the failing heart to maintain adequate tissue perfusion. In this study, the BAF solution is circulated through the MCL using a piston pump (SuperPump (AR Series), ViVitro Labs, Inc., Victoria, BC, Canada), which is fluid-coupled to a suspended silicone mock LV sac. An MCL can be an effective regulatory tool for simulating different patient disease states and evaluating the flow performance of MCS devices over their entire operating ranges in a well-controlled environment.
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Visit SourceS Kaule, M Stiehm, S Siewert, A Öner, KP Schmitz, and F Borowksi. Current Directions in Biomedical Engineering, vol. 9, no. 1, 2023, pp. 503-506.
We investigated the comparability between steady-state and transient PVL measurements as an input parameter for simulations in virtual cohorts. For the pulsatile flow testing we used a commercial pulse duplicator system (ViVitro Labs, Inc., Victoria, BC, Canada). An increasing pressure on the closed Evolut PRO TAVR in different annuls models during the steady flow measurements resulted in an increased flow.
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Visit SourceWang A, Wang Y, Liu W, Liu L, Zhou J. The International Journal of Artificial Organs. 2023;0(0)
We aimed to elucidate the effects of the micro-structure of the pyrolytic carbon for artificial heart valves on its hydrodynamic performance. A Vivitro PD 2010 pulse duplicator system was used. The parallel-groove pattern on leaflet surface affected the hemodynamic performance of the valve prostheses.
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Visit SourceDylan Armfield, Shane Conway, Scott Cook, Mert Celikin, Philip Cardiff, University College Dublin, Boston Scientific Galway
Towards developing a simulation methodology for the design of next-generation Transcatheter Aortic Valve Replacement (TAVR) devices, this numerical study investigates the impact of bioprosthetic valve stiffness and anisotropic behaviour on the fatigue of the nitinol stent frame during a single cardiac cycle. The simulation results were compared to in vitro testing of the device in a ViVitro pulse duplicator. The leaflet anisotropy can have a significant impact on how well the valve closes during the diastole phase, as well as whether the stent frame is symmetrically loaded, which may impact the overall fatigue life of the nitinol stent.
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Visit SourceArianna Callera, Politecnico Milano Scuola di Ingegneria Industriale e Dell'Informazione
This work focuses on introducing more physiological conditions for testing of aortic valve prosthesis and comparing the changes in behavior of different valve substitutes in these conditions. The most used commercial test bench is the ViVitro Pulse Duplicator, composed by a pump, a model left heart, a flow measuring system and a data acquisition system. In this work we have shown that it is possible to exploit 3D printing to obtain an aortic phantom with physiological mechanical and geometrical characteristics and use it to perform pulsatile tests on aortic valve prosthesis.
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Visit SourceSarah E. Motta, Michael M. Peters, Christophe O. Chantre, Huibin Chang, Luca Cera, Qihan Liu, Elizabeth M. Cordoves, Emanuela S. Fioretta, Polina Zaytseva, Nikola Cesarovic, Maximilian Y. Emmert, Simon P. Hoerstrup, Kevin Kit Parker, Matter 6, 1860–1879
Current valve manufacturing technologies struggle to create valves that facilitate native tissue remodeling for permanent replacements. FibraValve samples were sutured onto 28 mm nitinol stents and positioned into custom made holders for mounting in a pulse duplicator (ViVitro Labs, Victoria, BC, Canada). Here, we show that FRJS can serve as a biofabrication method for implantable heart valves.
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Visit SourceMariam Abdi Noor, Leila Louise Benhassen, Alexander Emil Kaspersen, Marc Gjern Weiss, John Michael Hasenkam, Peter Johansen, J. of Cardiovasc. Trans. Res.
The aim of this study was to evaluate and compare a novel open aortic annuloplasty ring (the A-ring) with the Dacron ring. The ventricular chamber was coupled to a digitally controlled piston pump (SuperPump AR Series, ViVitro Labs, Victoria, Canada), delivering a pulsatile flow to simulate left ventricular ejection into the aortic root. Overall, the echographic data revealed that both interventions had a downsizing effect on the aortic root, while still maintaining the distensibility comparable to the native condition.
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Visit SourceShin Yajima, Yuanjia Zhu, Charles J. Stark, Robert J. Wilkerson, Matthew H. Park, Elde Stefan, Y. Joseph Woo, The American Association for Thoracic Surgery
This study aimed to biomechanically evaluate the force profiles on the anterior primary and secondary chordae after neochord repair for anterior valve prolapse with varied degrees of residual mitral regurgitation using an ex vivo heart simulator. Briefly, a 3D printer was used to rapidly develop a prototype of a modular left heart coupled to a pulsatile linear actuator (ViVitro Superpump; ViVitro Labs). In our ex vivo AVP model, moderate residual MR following neochord repair was significantly associated with increased forces for both anterior primary and secondary chordae compared with those of less-than-moderate residual MR.
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Visit SourceFinja Borowski, Sebastian Kaule, Jan Oldenburg, Klaus-Peter Schmitz, Alper Öner, and Michael Stiehm, tm - Technisches Messen
Durability of transcatheter aortic valve replacement (TAVR) could be limited by leaflet thrombosis. A commercially available pulse duplicator system (ViVitro Inc., Victoria, BC, Canada) was used to generate physiological flow and pressure conditions of the cardiovascular circulation. Since commissural alignment in TAVR has only recently become the focus of clinical research, there is a clear gap in understanding the long-term clinical impact of commissural alignment.
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Visit SourceSofia Di Leonardo, Danila Vella, Carmelo Savio Grillo, Carla Martorana, Salvatore Torre, Vincenzo Argano, Gaetano Burriesci, European Journal of Cardio-Thoracic Surgery, ezad040
This work investigates the impact of the valve-sparing technique on the aortic valve function. The hydrodynamic performance assessment of each implant was conducted in-vitro on a hydro-mechanical pulse duplicator. This shows that, despite providing generally good performance, current valve sparing techniques are still suboptimal and far from matching the physiological leaflets dynamics.
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