Articles Related to Heart Valve Testing

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.

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Lisa Carlson Hanse, Marcell J Tjørnild, Simon G Sørensen, Peter Johansen, Ignacio Lugones, Vibeke E Hjortdal, Interactive CardioVascular and Thoracic Surgery, Volume 35, Issue 4, October 2022, ivac227

We investigated a new surgical technique of trileaflet semilunar valve reconstruction possessing the potential of remaining sufficient and allowing for some growth with the child. Pulsatile flow was produced by a Series piston pump (SuperPump AR; ViVitro Labs, Victoria, Canada), connected to the ventricular chamber. TSVR was achievable in vitro. Hydrodynamic pressure and echocardiographic evaluations demonstrated a sufficient and non-stenotic neo-valve.

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David Meier, Mariama Akodad, Andrew G. Chatfield, Georg Lutter, Thomas Puehler, Lars Søndergaard, David A. Wood, John G. Webb, Stephanie L. Sellers, and Janarthanan Sathananthan, J Am Coll Cardiol Intv. 2022 Aug, 15 (15) 1532–1539

The aim of this study was to assess the impact of commissural misalignment (CMA) on hydrodynamic function following VIV intervention with the ACURATE neo THV using a bench model. In VIV using the ACURATE neo THV at deep implantation, increasing degree of CMA was associated with THV leaflet interaction with those of the surgical valve and worsening regurgitant fraction. THV leaflet interaction was prevented when there was CA.

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K.Yu. Klyshnikov, E.A. Ovcharenko, Yu.A. Kudryavtseva, L.S. Barbarash, RUSSIAN JOURNAL OF TRANSPLANTOLOGY AND ARTIFICIAL ORGANS, Vol. XXII, No 2–2020

The aim of the study was an in vitro hydrodynamic study of the developed prosthetic heart valve of the second generation, designed to carry out an implantation using “valve-in-valve” method. ...Prototypes of the developed prosthesis were studied under simulated physiological conditions of the heart using a Vivitro Labs pulse duplicator (Canada) in a comparative aspect with “UniLine” clinical commercial aortic valve bioprosthesis (Russia)... ...The design of the prosthesis under development has shown its consistency in terms of functional characteristics, both in comparison with the original UniLine prosthesis and with literature data....

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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, bioRxiv submission manuscript, TIFF, 23 June 2022

A derived laboratory metric for valve closing flow velocity offers a way to rank valve models for potential blood damage. These results provide new insight and a mechanistic explanation for prior clinical observations where aortic and mitral valve replacements differ in thrombogenic potential and anticoagulation requirement. The study suggests a path forward to design and evaluate novel mechanical valve models for future development. ...In 2009, work transitioned into a separate independent research and development enterprise, ViVitro Laboratories Inc. (VLI) also based in Victoria, BC, Canada... ...This work exposes the central relationship between thrombogenicity and predicted high velocity flows and shear forces at valve closure. As practical application of our findings, specific valve geometric features were identified that led to prototype designs with potential for further development...

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Libby H. Welborn, Anna K. Himes, Ida E. Greenlee, Nyna J. DeWitt, Ava T. Burgess, Brandon K. Eberl, Olga Pierrakos, 2022 Systems and Information Engineering Design Symposium (SIEDS)

The aim of this paper is to: 1) showcase the design process of a quadleaflet ePTFE valved conduit with a diameter of 16mm or less and 2) offer a hemodynamic performance comparison. ...The proposed valve was tested using the ViVitro Pulse Duplicator under physiologic cardiac conditions... ...A comparison between the two ePTFE handmade valves (trileaflet and quadleaflet) demonstrated hemodynamic differences in regurgitation due to leaflet number. The handmade valves both showed increased regurgitation compared to a Carbomedics valve (commercially available design). Regurgitation had varying effects on pressure gradients and cardiac output...

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H. Appa, K. Park, D. Bezuidenhout, B. van Breda, B. de Jongh, J. de Villiers, R. Chacko, J. Scherman, C. Ofoegbu, J. Swanevelder, M. Cousins, P. Human, R. Smith, F. Vogt, B, K. Podesser, C. Schmitz, L. Conradi, H. Treede, H. Schröfel, T. Fischlein, M. Grabenwöger, X. Luo, H. Coombes, S. Matskeplishvili, D. F. Williams, P. Zilla, Front. Cardiovasc. Med., 03 March 2022

...Hydrodynamic testing to determine gradients (ΔP), effective orifice areas (EOA) and regurgitant fractions was performed in a pulse duplicator (Cardiac Output: 5 L/min; 37°C; 70 bpm; Stroke Volume: 32 ± 5 ml; Systolic Phase Duration of 35 ± 5%) (ViVitro Labs Inc; Victoria, BC, Canada)...The BE TAVR system met all requirements for which it was developed...

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M. Alizadeh, M. Cote, A. Branzan Albu, Proceedings of the IEEE/CVF Winter Conference on Applications of Computer Vision 2022

...Our experimental setup to collect high-quality videos and pressure and velocity data involves tricupsid BHVs mounted in the Pulse Duplicator device from ViVitro Labs...Experiments on four cases that include three different tricuspid BHVs yielded promising results, with the DTW scores showing a good coherence with respect to the simulations...

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B. Ncho, A. Siefert, V. Sadri, J. Ortner, A. Yoganathan. Journal or Med. Devices

The physiologic pressures and flows were achieved by adjustment of systemic resistance and compliance elements, and flow driven from a piston pump (Vivitro Labs Inc. Victoria, Canada).

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C. D. Hsu, A. Mirza, R. Matheny, S. Ramaswamy. Structural Heart. Vol. 5.

...hydrodynamic testing of the valves mounted in mitral and tricuspid positions were performed using a pulse duplicator system (ViVitro Labs) using 0.9% saline solution...

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Jae H. Lee, Alex D. Rygg, Ebrahim M. Kolahdouz, Simone Rossi, Stephen M. Retta, Nandini Duraiswamy, Lawrence N. Scotten, Brent A. Craven, and Boyce E. Grith -

Computer modeling and simulation (CM&S) is a powerful tool for assessing the performance of medical devices such as bioprosthetic heart valves (BHVs) and promises to accelerate device design and regulation. This study describes work to develop dynamic computer models of BHVs in the aortic test section of an experimental pulse duplicator platform that is used in academia, industry, and regulatory agencies to assess BHV performance... ...This work represents a step towards the experimental validation of this FSI modeling platform for evaluating BHVs.... … In vitro experiments are performed using two different experimental platforms, including a ViVitro Pulse Duplicator (ViVitro Labs, Inc., Victoria, BC, Canada) available through the FDA Cardiac Device Flow Lab and a customized …

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Feng Guo (郭峰)Chang Liu (刘唱)Rizheng Han (韩日峥)Qiang Lu (吕强)Yun Bai (白芸)Rui Yang (杨锐)Dun Niu (牛盾)Email authorXing Zhang (张兴) -Science China Materials

Herein, two types of silk fibroin (SF) fiber membranes with anisotropic (ASF) and isotropic (ISF) properties were prepared by electrospinning, and were further combined with poly(ethylene glycol) diacrylate (PEGDA) hydrogels to serve as polymeric heart valve (PHV) substitutes (PEGDA-ASF and PEGDA-ISF)... ...The PHVs from both PEGDA-ASF and PEGDA-ISF presented appropriate hydrodynamic properties from pulse duplicator tests according to the ISO 5840-3 standard.... ...The Gauss curvature analysis also indicated that the anisotropic PEGDA-ASF valve can produce appropriate surface morphology by dynamically adjusting the movement of bending area during the opening process... … 1c, d). Pulse duplicator tests In vitro hemodynamic properties of PHVs were tested in a 0.9% saline solution using a pulse duplicator system (Vivitro Labs, Inc., British Columbia, Canada) according to the ISO 5840-3 standard [21] …

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Miss Brittany A. Gonzalez, Miss Elnaz Pour Issa, Mr. Omkar V. Mankame, Miss Jenniffer Bustillos, Mr. Antonio Cuellar, Mr. Andres J. Rodriguez, Dr. Frank Scholl, Dr. Steven Bibevski, Dr. Lazaro Hernandez, Mr. Vincent Brehier, Mr. Mike Casares, Dr. Krishna Rivas, Dr. Pablo Morales, Mr. Jesus Lopez, Dr. Joseph Wagner, Dr. Jennifer Bibevski, Dr. Arvind Agarwal, Dr. Florence George, and Dr. Sharan Ramaswamy - Tissue Engineering Part A. December 5, 2019

Conceptually, a tissue engineered heart valve (TEHV) would be especially appealing in the pediatric setting since small size and somatic growth constraints would be alleviated. Here, we utilized porcine small intestinal submucosa (PSIS) for valve replacement... … the Dacron tubes housing the PSIS valves were measured in order to secure the valve‐in‐ conduit (Figure 1) in the mitral position within a pulse duplicator system (ViVitro Labs, Victoria, BC) … A pulse duplicator system… ... Our findings suggest that the altered structural responses of PSIS, post-fatigue, rather than de novo tissue formation, are primarily responsible for the valve’s ability to accommodate somatic growth during the acute phase (90 days) following mitral valve replacement...

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Jae H. Lee, Alex D. Rygg, Ebrahim M. Kolahdouz, Simone Rossi, Stephen M. Retta, Nandini Duraiswamy, Lawrence N. Scotten, Brent A. Craven, and Boyce E. Grith - ResearchGate 2019

This study describes work to develop dynamic computer models of BHVs in the aortic test section of an experimental pulse duplicator platform... ...We compare our numerical simulations to experimental data from two similar pulse duplicators, including a commercial ViVitro system and a custom platform related to the ViVitro pulse duplicator.... ...This work represents a step towards the experimental validation of this FSI modeling platform for evaluating BHVs....

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Amanda Barreto,Asad M. Mirza, Daniel Chaparro, Ahmed Z. Ali, Rachel Montlavan, Joshua D. Hutcheson, Sharan Ramaswamy - FIU Digital Commons

... Aortic valve calcification (AVC) is caused by defects in the valves and it is a health condition which usually requires surgical valve replacement... ...The proposed project aims to capture images of the aortic leaflet curvature while cyclic flexure is conducted... The curvature of the leaflets will be captured using two high-frame rate video systems. The aortic valve leaflet flexure experiments will be produced using a Vivitro Pulse Duplicator (Vivitro Labs Inc. Victoria, BC, Canada) …

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Immanuel David Madukauwa-DavidVahid SadriPrem A MidhaVasilis BabaliarosCyrus AidunAjit P. Yoganathan - Annals of Biomedical Engineering First Online: 16 July 2019

Transcatheter heart valve (THV) leaflet thrombosis in the neo-sinus and associated reduced leaflet motion is of clinical concern due to risks of embolism and worsened valve hemodynamics... ...We tested two replicas of FDA approved commercial THVs—intra-annular and supra-annular (similar to the SAPIEN 3 and CoreValve families)—in a left heart simulator with coronary flow... … The Georgia Tech left heart simulator is shown in Fig. 2a. The main flow rate was driven by the primary piston pump (Vivitro Labs Inc. Victoria, Canada); wall-tapped pressure transducers (Deltran DPT-200, Utah Medical Products Inc

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Fergal B. Coulter, Manuel Schaffner, Jakob A. Faber, Ahmad Rafsanjani, Robin Smith, Harish Appa, Peter Zilla, Deon Bezuidenhout, and Andre´ R. Studart - Matter, 2019

Synthetic implants made by traditional fabrication routes are not patient specific and rarely match the performance of their biological counterparts. We present an additive manufacturing approach for the digital fabrication of tissue-like aortic heart valves featuring customizable geometry and leaflet architectures that resemble those of native valve tissue... ...Flow was driven by a forward pressure of 100 mmHg imposed across the valve using a pulsatile testing machine (PD2010; ViVitro, Victoria, BC, Canada)... ...The ability to fabricate synthetic implants with tailored designs at multiple length scales is a key contribution toward the digital fabrication of functional implants that perform on par with native body parts...

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Changfu Wu, Neelakantan Saikrishnan, Aaron J. Chalekian, Rob Fraser, Ornella Ieropoli, Stephen M. Retta, Russell Joseph, Shouyan Lee, Salvador Marquez, David Mester, Ning Pan, Sepehr Vatanpour, Craig Weinberg, Ulrich Steinseifer - Cardiovascular Engineering and Technology 2019

...A round-robin study carried out in 2005 in accordance with ISO 5840:2005 revealed significant variabilities in prosthetic heart valve hydrodynamic performance measurements among the participating laboratories. In order to re-examine the inter-laboratory variability based on the “state-of-the-art” under ISO 5840-1 and 5840-2:2015, the ISO Cardiac Valve Working Groups decided in 2016 to repeat the round-robin study.... … took part in the round-robin study, including one academic laboratory (Helmholtz Institute of the RWTH University, Aachen, Germany), three testing service providers (BDC Laboratories, Wheat Ridge, CO; Medical Implant …

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Utku Gülan Harish Appa Pascal Corso Christian Templin Deon Bezuidenhout Peter Zilla Firat Duru Markus Holzner - Artificial organs, 2019

...In this study, we aimed at investigating the impact of transcatheter aortic valve implantation (TAVI) devices on blood flow patterns that develop in the ascending aorta under physiological flow conditions in vitro... … Graphics, Heidelberg, Germany). Valve hydrodynamics A Pulse Duplicator System (ViVitro Labs Inc) was used for the assessment of heart valve performance and function under simulated cardiac conditions. The system is a … ...We conclude that the characteristics and material designs of TAVI devices have strong influences on the hemodynamics in the ascending aorta...

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