Articles Related to Heart Valve Testing

Breitenstein-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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J. 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.

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S. 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  HiCycle Durability Tester  Pulse Duplicator

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Karl, R., Leister, R., Stroh, L., Mereles, D., Eden, M., Neff, L., Simone, R.D., Romano, G., Kriegseis, J., Karck, M., Lichtenstern, C., Frey, N., Frohnapfel, B., Stroh, A., & Engelhardt, S.

Mitral regurgitation (MR) is one of the most common valvular heart conditions and caused by the retrograde flow of blood from the left ventricle (LV) into the left atrium (LA) through the mitral valve (MV). The frequency of the pump (ViVitro SuperPump, ViVitro Labs, Inc., Victoria, Canada) is adjusted to 80 bpm and the stroke volume of the pump is set to reach a left ventricular pressure of approximately 120 mmHg. The present work compares the measurement of regurgitation jet by ultrasound accomplished by three different physicians with three different systems.

Other Products Cited:  Analysis and Computational Modeling  Flow Visualization  SuperPump

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Meskin, 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  Pulsatile Flow Simulation  Pulse Duplicator  SuperPump

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Spanjaards, 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  Pulse Duplicator

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Masheane, 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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Viktória 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.

Other Products Cited:  Analysis and Computational Modeling  Pulse Duplicator

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S 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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Wang 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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Dylan 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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Arianna 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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Sarah 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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Shin 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.

Other Products Cited:  Ex ViVo Simulation  Pulsatile Flow Simulation  Pulse Duplicator

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Sofia 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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Robert J Melder, Filippo Naso, Francesco Nicotra, Laura Russo, Ivan Vesely, Sugat R Tuladhar, Antonio M Calafiore, Peter Zilla, Alessandro Gandaglia, Sotiris Korossis, European Journal of Cardio-Thoracic Surgery, ezac583

This study was to evaluate the impact of a polyphenols-based treatment on the extrinsic mechanisms responsible for early BHV degeneration. The hydrodynamic performance of the polyphenolic-treated and untreated T-GT commercial BHVs was assessed under simulated pulsatile flow in a Vivitro Pulse Duplicator System. The treatment is chemically stable, improves tissue extensibility, and effectively stabilizes glutaraldehyde.

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Yuanjia Zhu, Matthew H. Park, Annabel Imbrie-Moore, Robert Wilkerson, Sarah Madira & Y. Joseph Woo, Journal of Cardiothoracic Surgery volume 17, Article number: 303 (2022)

Aortic regurgitation (AR) is one of the most common cardiac valvular diseases, and it is frequently caused by cusp prolapse. The simulator contains a programmable pulsatile linear piston pump (ViVitro Superpump, ViVitro Labs) and a viscoelastic impedance adapter (ViVitro) that is comprised of two compliance chambers and a fixed resistance element and generates a physiologic ventricular waveform. In this study, we successfully designed a commissure geometric alignment device that can manipulate aortic commissure positions to induce aortic cusp prolapse.

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Feng Guo, Rizheng Han, Jishan Ying, Zeping Zhang, Rui Yang, Xing Zhang, Journal of Materials Science & Technology, Volume 144, 1 May 2023, Pages 178-187

In this work, bioinspired anisotropic polymeric heart valves were fabricated using composite materials from polyurethane (PU) and natural cellulose fiber bundles. The hydrodynamic performance of the polymeric valve was evaluated by the ViVitro Pulse Duplicator system. Our results demonstrate the potential application of bioinspired anisotropic CPU composites as polymeric heart valves.

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Lawrence N. Scotten, Rolland Siegel, David J. Blundon, Marcus-André Deutsch, Terence R. P. Martin, James W. Dutton, Ebrahim M. Kolahdouz, Boyce E. Griffith

To demonstrate a clear link between predicted blood shear forces during valve closure and thrombogenicity that explains the thrombogenic difference between tissue and mechanical valves and provides a practical metric to develop and refine prosthetic valve designs for reduced thrombogenicity. Incorporated as Vivitro Systems Inc (VSI), our primary focus was research, design and development of cardiac valve implant devices and on the laboratory test systems required. In 2009, work transitioned into a separate independent research and development enterprise, ViVitro Laboratories Inc. (VLI). The application of unique technology, rapid prototyping and ranking of flow velocity patterns near valve closure optimized experimental valve geometry for reduced thrombus potential compared with control valves.

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David Meier, MD; Geoffrey W. Payne, MSc, PhD; Leila B. Mostaço-Guidolin, PhD; Rihab Bouchareb, MSc, PhD; Courtney Rich, BASc; Althea Lai, BSc; Andrew G. Chatfield, MB ChB; Mariama Akodad; Hannah Salcudean, MSc; Georg Lutter, MD; Thomas Puehler, MD; Philippe Pibarot, DVM, PhD; Keith B. Allen, MD; Adnan K. Chhatriwalla, MD; Lars Sondergaard, MD; David A. Wood, MD; John G. Webb, MD; Jonathon A. Leipsic, MD; Janarthanan Sathananthan, MPH, MBChB; Stephanie L. Sellers, MSc, PhD, EuroIntervention 2022;17:1-1

To assess the impact of bioprosthetic valve fracture (BVF) timing on long-term transcatheter heart valve (THV) durability. Valve testing was performed in the ViVitro Labs testing facilities (ViVitro Labs Inc, Victoria, Canada). Hydrodynamic testing was performed using a commercially available pulse duplicator (ViVitro Labs Inc, Victoria, Canada), meeting the equipment requirements defined in ISO 5840-3 for pulsatile flow testing (16) (Figure 1A). In this bench study, the ACn and the S3 showed acceptable hydrodynamic performances after AWT to 200M cycles, equivalent to 5 years, irrespective of BVF timing compared to no fracture.

Other Products Cited:  HiCycle Durability Tester

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