and Drug Administration
- U. S. Foo
- Draft guidance for industry and FDA staff: heart…
OBJECTIVE To complement the ISO 5840 standards concerning the duration of left ventricular systole and diastole as a function of changes in heart rates according to in vivo studies from the physiologic literature review. METHODS The systolic and diastolic durations from three in vivo studies were compared with the durations of systole proposed by the ISO 5840:2010 and ISO 5840-2:2015 for hydrodynamic performance assessment of prosthetic heart valves. RESULTS Based on the in vivo studies analyzed, the systolic durations proposed by the ISO 5840 standard seemed consistent for 45 and 120 beats per minute (bpm), and showed diverse results for the 70 bpm condition. CONCLUSION Information on the realistic validation of the operation of left ventricular models for different heart rates were obtained.