Clinical utility of microaxial flow pump fiber-optic pressure sensor for real-time hemodynamic monitoring in cardiogenic shock

Background The Impella 5.5 has demonstrated clinical efficacy in managing cardiogenic shock, featuring an integrated fiber-optic sensor facilitating real-time aortic pressure monitoring via the Placement Signal (PS); however, the reliability of the PS has not been systematically evaluated. The objective of this study was to assess its accuracy by correlating PS with invasive arterial line pressure (ALP) measurements. Methods We compared Impella 5.5 PS data (25 samples per second) with systolic, diastolic, and mean ALP values. Impella signals were derived from detected systolic and diastolic PS components. In addition to Bland-Altman analyses, regression analyses, percentage error, and trending ability using error field concordance analysis were evaluated. Secondary outcomes included bias analyses across postoperative days (PODs), performance level (P-level), and reference pressure ranges. Results From 209,183 data points across 53 patients, assessment of agreement revealed a mean signal bias of −4.9 mmHg (95% CI: −6.2 to −3.5), with strong correlations identified between mean ( r = 0.823), diastolic [ r = 0.793, bias: −2.4 mmHg (95% CI: −3.7 to −1.0)], and systolic signals [ r = 0.777, bias: −13.8 mmHg (95% CI: −16.3 to −11.2)]. The mean signals resulted in a percentage a percentage error of 20.3% and an error field concordance of 43.4 ± 51.4%. Poor association was found to PODs [ β = −0.135 mmHg per POD (95% CI: −0.147 to −0.123), p < 0.001] and no significant association to P-levels [ β = 0.014 mmHg per P-level (95% CI: −0.023 to 0.050), p = 0.467]. Minor discrepancies within ± 3.9 mmHg across pressure ranges were observed. Conclusion This study assessed invasive hemodynamic data recorded with the Impella 5.5 demonstrating strong agreement and correlation with clinical reference signals. The fiber-optic pressure sensor indicated statistical concordant, suggesting potential trending ability. Negligible magnitude in signal drift was observed, and measurements were independent of support settings and pressure ranges. Reliable aortic pressure waveform assessment during microaxial flow pump therapy may enhance hemodynamic monitoring.