Changfu Wu1, Neelakantan Saikrishnan2,3, Aaron J Chalekian4, Rob Fraser5, Ornella Ieropoli6, Stephen M Retta7, Russell Joseph8, Shouyan Lee9, Salvador Marquez8, David Mester10, Ning Pan11, Sepehr Vatanpour12, Craig Weinberg13, Ulrich Steinseifer14. 1. Center for Devices and Radiological Health, Food and Drug Administration, Silver Spring, MD, USA. Changfu.Wu@fda.hhs.gov. 2. Abbott, St. Paul, MN, USA. 3. Vdyne LLC, Maple Grove, MN, USA. 4. Neovasc (U.S.) Inc, New Brighton, MN, USA. 5. ViVitro Labs, Victoria, BC, Canada. 6. Sorin Group Italia s.r.l. (fully owned by LivaNova Plc), Saluggia, VC, Italy. 7. Center for Devices and Radiological Health, Food and Drug Administration, Silver Spring, MD, USA. 8. Edwards Lifesciences LLC, Irvine, CA, USA. 9. Medical Implant Testing Lab, Irvine, CA, USA. 10. W. L. Gore & Associates, Inc., Flagstaff, AZ, USA. 11. Boston Scientific, Los Gatos, CA, USA. 12. Medtronic Inc, Minneapolis, MN, USA. 13. BDC Laboratories, Wheat Ridge, CO, USA. 14. RWTH-Aachen University, Aachen, Germany.
Abstract
PURPOSE: Hydrodynamic performance testing is one of the core in vitro assessments required by the ISO 5840 series of standards for all prosthetic heart valves. 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. METHODS: A total of 13 international laboratories participated in the study. The test valves were chosen to be the St. Jude Medical Masters Series mechanical valves (19 mm aortic, 25 mm aortic, 25 mm mitral, and 31 mm mitral), which were circulated among the laboratories. The testing was conducted according to a common test run sequence, with prespecified flow conditions. RESULTS: The study revealed improved, yet still significant variability among different laboratories as compared to the 2005 study. The coefficient of variation ranged from 7.7 to 21.6% for the effective orifice area, from 10.1 to 32.8% for the total regurgitant fraction, and from 14.7 to 45.5% for the mean transvalvular pressure gradient. CONCLUSIONS: The study revealed the ambiguities in the current versions of the ISO 5840 series of standards and the shortcomings of some participating laboratories. This information has allowed the ISO Working Group to incorporate additional clarifying language into the ISO 5840-1, -2, and -3 standards that are currently under revision to improve in vitro assessments. The results presented here can also be used by the testing laboratories to benchmark pulse duplicator systems and to train and certify testing personnel.
PURPOSE: Hydrodynamic performance testing is one of the core in vitro assessments required by the ISO 5840 series of standards for all prosthetic heart valves. 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. METHODS: A total of 13 international laboratories participated in the study. The test valves were chosen to be the St. Jude Medical Masters Series mechanical valves (19 mm aortic, 25 mm aortic, 25 mm mitral, and 31 mm mitral), which were circulated among the laboratories. The testing was conducted according to a common test run sequence, with prespecified flow conditions. RESULTS: The study revealed improved, yet still significant variability among different laboratories as compared to the 2005 study. The coefficient of variation ranged from 7.7 to 21.6% for the effective orifice area, from 10.1 to 32.8% for the total regurgitant fraction, and from 14.7 to 45.5% for the mean transvalvular pressure gradient. CONCLUSIONS: The study revealed the ambiguities in the current versions of the ISO 5840 series of standards and the shortcomings of some participating laboratories. This information has allowed the ISO Working Group to incorporate additional clarifying language into the ISO 5840-1, -2, and -3 standards that are currently under revision to improve in vitro assessments. The results presented here can also be used by the testing laboratories to benchmark pulse duplicator systems and to train and certify testing personnel.
Entities:
Keywords:
Effective orifice area; Hydrodynamic performance testing; Mean pressure gradient; Prosthetic heart valves; Total regurgitant fraction; Waveform
Authors: Jae H Lee; Alex D Rygg; Ebrahim M Kolahdouz; Simone Rossi; Stephen M Retta; Nandini Duraiswamy; Lawrence N Scotten; Brent A Craven; Boyce E Griffith Journal: Ann Biomed Eng Date: 2020-02-07 Impact factor: 3.934