Clinical evaluation of an optical fiber-based probe for the assessment of central arterial pulse waves.

The aim of this study, enrolling 118 patients, was to clinically evaluate the accuracy of carotid pulse waveform acquisition with a new non-invasive optical fiber probe using invasive and non-invasive pressure readings as references. Pulse waves were acquired simultaneously in the ascending aorta and right common carotid; for the non-invasive study, the pulses were sequentially acquired using the optical fiber device and the Complior Analyse® (Alam Medical, France) device in the right carotid artery. For all subjects, the pulse waveforms assessed using the optical fiber sensor and the references were superimposed to analyze the deviation and point-by-point correlation. Augmentation index and central pressure were compared using intraclass correlation and Bland-Altman analyses with a confidence interval of 95%. For the invasive study, the acquired waves presented a mean deviation of 11 ± 3% and a mean intraclass correlation of 0.97 ± 0.02. Concerning the augmentation index and central systolic pressure, correlations of 0.79 (p < 0.001) and 0.94 (p < 0.001) were found, respectively. In the non-invasive comparison, the assessed mean deviation between the morphologies of the waves was 13 ± 5%, with correlation coefficients of 0.91 (p < 0.001) for the augmentation index and 0.98 (p < 0.001) for central systolic pressure. The results show that the optical fiber probe results were highly correlated with those obtained using the reference techniques in terms of the pulse waveforms, central systolic pressure (cSP), and augmentation index assessment.