Are Reference valve(s) provided for hydrodynamic performance testing?
ISO 5840-2:2021 and 5840-3:2021 now require performance characterization of pulse duplicator system performance.
Reference valves are used as an integral part of validation for testing on the ViVitro Labs Pulse Duplicator system. Reference valves are used for internal quality assurance to ensure the Pulse Duplicator is working as expected. A Reference valve is run once before and after every day of testing. A round robin study was conducted across multiple industry and academic test laboratories using St. Jude Masters Series mechanical valves. The results from this study were summarized and published in ISO 5840-2:2021 in Table F.1.
Testing the valve hydrodynamic performance in the intended range of conditions using two different ViVitro Pulse Duplicators in two different locations was done to further characterize the performance of a Pulse Duplicator as well as further verify the hydrodynamic results of these valves. Although these valves have been tested and results published, this study ensured the valves conform to the expected published results.
25 mm St. Jude Medical Masters Series mechanical valves were tested in their silicone and Delrin holder. Testing was conducted with sealing applied around the valve sample perimeter as described in QV-411 to avoid paravalvular leakage. Testing was conduct on one valve at a time. The ViVitro Pulse Duplicator was used for pulsatile testing and test was conducted according to ViVitro Labs Hydrodynamic Test Method/OLE1714. All reference test valves were tested individually in both the aortic and mitral position of the Pulse Duplicator.. The test valves were orientated such that coaptation edge of the two leaflets is parallel with the front face of the model left heart resulting in the same effect of gravity on each leaflet. During pulsatile testing, ViVitro Labs spring-loaded disk valves were used as the companion valves, in both the artic and mitral position, respectfully. Each valve sample was tested in the pulse duplicator at a nominal conditions at ViVitro Labs SASU in Marseille, France and then sent in their respective labelled containers to ViVitro Labs, Victoria, Canada, for testing.
The ViVitro Labs Pulse Duplicator characterization valve kit includes a ISO 5840:2021 ViVitro Labs Pulse Duplicator characterization test method and St. Jude Master’s valve with certified results for the ViVitro Pulse duplicator.