116 Chapter 4 Ethics The study was conducted following the Declaration of Helsinki [25]. Because of the retrospective character, using data obtained in the context of regular FD patient care, the Amsterdam University Medical Centres Medical ethics committee confirmed that the Medical Research Involving Human Subjects Act does not apply to the used data of FD patients. Before data collection in the healthy Rotterdam cohort, the local ethics committee at the Erasmus MC approved the protocol and all subjects signed informed consent. Data collection Echocardiographic assessments Between March 2004 and February 2021, FD patients underwent echocardiograms (Vivid 7 or E95, GE Healthcare, Milwaukee, WI, USA) obtained by experienced technicians, according to a standard outpatient clinic protocol. For each patient we selected the two echocardiograms with the longest period between them. All echocardiographic images were re-assessed and re-measured if deemed necessary, by a single observer (MES). The healthy volunteers underwent an echocardiogram (Philips iE33 and EPIQ7 ultrasound systems) during a one day visit between 2014 and 2015. The following echocardiographic features were assessed: end-diastolic interventricular septum thickness (IVSd), end-diastolic left ventricular posterior wall thickness (LVPWd), left ventricular end- diastolic diameter (LVEDd), left atrium volume index (LAVI), early diastolic mitral inflow velocity (E), peak velocity flow in late diastole caused by atrial contraction (A), early diastolic septal tissue mitral annulus velocity (septal e’), biplane left ventricular ejection fraction (LV EF), Tricuspid Annular Plane Systolic Excursion (TAPSE) and global longitudinal strain (GLS). The Relative wall thickness (RWT) (IVSd + LVPWd/ LVEDd) and Left ventricular mass index (LVMi in g/m2)= (0.8{1.04[([LVEDd + IVSd +LVPWd]3 – LVEDd3)]} + 0.6)/( weight0.425 * length0.725 * 0.007184) [26] were calculated using the LV dimension parameters. GLS was measured only in the last available echocardiogram of each FD patient, since the image quality of the earlier ultrasounds was often insufficient to produce accurate measurements.The maximal tricuspid regurgitation velocity (TR Vmax) and sinus of Valsalva (SoV) diameter were not available of the healthy control subjects and thus only reported for the FD patients. To get an overall impression of the left ventricular (LV) diastolic function in FD patients, this was scored on the last available echocardiogram.
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