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Peer-reviewedCC BY 4.0Frontiers in Cardiovascular Medicine

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

5 affiliations
  1. 1Center for Medical Physics and Biomedical Engineering, Medical University of Vienna
  2. 2Department of Cardiac and Thoracic Aortic Surgery, Medical University of Vienna
  3. 3Division of Cardiac Thoracic Vascular Anaesthesia and Intensive Care Medicine, Department of Anesthesia, Intensive Care Medicine and Pain Medicine, Medical University of Vienna
  4. 4Division of Cardiology, Department of Internal Medicine II, Medical University of Vienna
  5. 5Department of Internal Medicine I, Medical University of Vienna

Abstract

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.

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BibTeX
@article{ruoff2026clinical,
  title = {{Clinical utility of microaxial flow pump fiber-optic pressure sensor for real-time hemodynamic monitoring in cardiogenic shock}},
  author = {Lukas Ruoff and Roxana Moayedifar and Anne-Kristin Schaefer and Oliver Seibert and Barbara Karner and Martin H. Bernardi and Robert Zilberszac and Peter Schellongowski and Julia Riebandt and Daniel Zimpfer and Thomas Schlöglhofer},
  journal = {Frontiers in Cardiovascular Medicine},
  year = {2026},
  month = nov,
  doi = {10.3389/fcvm.2026.1977213},
  url = {https://www.frontiersin.org/articles/10.3389/fcvm.2026.1977213/full},
  note = {CC BY 4.0},
}
RIS
TY  - JOUR
TI  - Clinical utility of microaxial flow pump fiber-optic pressure sensor for real-time hemodynamic monitoring in cardiogenic shock
AU  - Lukas Ruoff
AU  - Roxana Moayedifar
AU  - Anne-Kristin Schaefer
AU  - Oliver Seibert
AU  - Barbara Karner
AU  - Martin H. Bernardi
AU  - Robert Zilberszac
AU  - Peter Schellongowski
AU  - Julia Riebandt
AU  - Daniel Zimpfer
AU  - Thomas Schlöglhofer
PY  - 2026
DA  - 2026/11/09
JO  - Frontiers in Cardiovascular Medicine
DO  - 10.3389/fcvm.2026.1977213
UR  - https://www.frontiersin.org/articles/10.3389/fcvm.2026.1977213/full
AB  - 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.
SN  - 2297-055X
ER  -