Vrishank Raghav1, Ikechukwu Okafor2, Michael Quach3, Lynn Dang3, Salvador Marquez3, Ajit P Yoganathan4. 1. Wallace H. Coulter Department of Biomedical Engineering, Georgia Institute of Technology & Emory University, Atlanta. 2. School of Chemical and Biomolecular Engineering, Georgia Institute of Technology, Atlanta, Georgia. 3. Edwards Lifesciences, Irvine, California. 4. Wallace H. Coulter Department of Biomedical Engineering, Georgia Institute of Technology & Emory University, Atlanta; School of Chemical and Biomolecular Engineering, Georgia Institute of Technology, Atlanta, Georgia. Electronic address: ajit.yoganathan@bme.gatech.edu.
Abstract
BACKGROUND: Durability and hemodynamic performance are top considerations in selecting a valve for valve replacement surgery. This study was conducted in order to evaluate the long-term mechanical durability and hydrodynamic performance of the Carpentier-Edwards PERIMOUNT Magna Ease Bioprostheses, through 1 billion cycles (equivalent to 25 years). METHODS: In vitro valve hydrodynamic performance, durability, and quantitative flow visualization were conducted in accordance with ISO 5840:2005 heart valve standard. The study valves were subjected to accelerated valve cycling to an equivalent of 25 years of wear. Hydrodynamic evaluations at intervals of 100 million cycles (2.5 years) were performed on the study valves. New uncycled Magna Ease valves were used as hydrodynamic controls in this study. A quantitative assessment of the fluid motion downstream of the control and study valves was performed using particle image velocimetry. The results between the test and control valves were compared to assess valve performance after an equivalent of 25 years of wear. RESULTS: All study valves met the ISO 5840 requirements for effective orifice area, 1.81 ± 0.06 cm(2) and 2.06 ± 0.17 cm(2), and regurgitant fraction, 1.11% ± 0.87% and 2.5% ± 2.34%, for the 21 mm and 23 mm study valves, respectively. The flow characterization of the control valves and the billion-cycle valves demonstrated that the valves exhibited similar flow characteristics. The velocity and shear stress fields were similar between the control and study valves. CONCLUSIONS: The Magna Ease valves demonstrated excellent durability and hydrodynamic performance after an equivalent of 25 years of simulated in vitro wear. All study valves successfully endured 1 billion cycles of simulated wear, 5 times longer than the standard requirement for a tissue valve as stipulated in ISO 5840.
BACKGROUND: Durability and hemodynamic performance are top considerations in selecting a valve for valve replacement surgery. This study was conducted in order to evaluate the long-term mechanical durability and hydrodynamic performance of the Carpentier-Edwards PERIMOUNT Magna Ease Bioprostheses, through 1 billion cycles (equivalent to 25 years). METHODS: In vitro valve hydrodynamic performance, durability, and quantitative flow visualization were conducted in accordance with ISO 5840:2005 heart valve standard. The study valves were subjected to accelerated valve cycling to an equivalent of 25 years of wear. Hydrodynamic evaluations at intervals of 100 million cycles (2.5 years) were performed on the study valves. New uncycled Magna Ease valves were used as hydrodynamic controls in this study. A quantitative assessment of the fluid motion downstream of the control and study valves was performed using particle image velocimetry. The results between the test and control valves were compared to assess valve performance after an equivalent of 25 years of wear. RESULTS: All study valves met the ISO 5840 requirements for effective orifice area, 1.81 ± 0.06 cm(2) and 2.06 ± 0.17 cm(2), and regurgitant fraction, 1.11% ± 0.87% and 2.5% ± 2.34%, for the 21 mm and 23 mm study valves, respectively. The flow characterization of the control valves and the billion-cycle valves demonstrated that the valves exhibited similar flow characteristics. The velocity and shear stress fields were similar between the control and study valves. CONCLUSIONS: The Magna Ease valves demonstrated excellent durability and hydrodynamic performance after an equivalent of 25 years of simulated in vitro wear. All study valves successfully endured 1 billion cycles of simulated wear, 5 times longer than the standard requirement for a tissue valve as stipulated in ISO 5840.
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