The main goal of this observational, study is to develop a clinical decision support tool utilizing Impella 5.5 pump parameters to predict native heart recovery and prevent adverse events, by leveraging data science and real-world clinical data of cardiogenic shock patients.
Therefore, secondary objectives are essential to consolidating a retrospective longitudinal analysis of Impella 5.5 pump data alongside ICU digital health record datasets to:
1. Validate the Impella 5.5 placement signal by comparing it with ICU arterial line waveforms. 2. Integrate pump data with ICU clinical data to identify patterns associated with therapy outcomes, including native heart recovery, heart replacement therapy, and mortality while on device support. 3. Define clinical scenarios linked to hemolysis, HRAEs, and arrhythmias and develop predictive models to mitigate their occurrence.
Adult patients who were treated for cardiogenic shock and supported with an Impella 5.5 micro-axial flow pump
Only patients with available high-resolution pump data (downloaded from the clinical console) and ICU digital health record datasets
Patients supported with an Impella 5.5 for indications other than cardiogenic shock (e.g., protected PCI or CABG)
Patients younger than 18 years
Patients with incomplete data, procedural records, or demographic information
The study population comprises adult patients admitted to the intensive care unit (ICU) presenting with severe cardiogenic shock who required temporary mechanical circulatory support between January 2019 and March 2026, treated at the Medical University of Vienna, Austria. Eligible individuals are those who undergo clinical management utilizing the Impella 5.5 micro-axial flow pump as part of their standard of care. Only patients with available high-resolution pump data (downloaded from the clinical console) and ICU digital health record datasets extracted from ICCA (IntelliSpace Critical Care and Anesthesia, Philips Medical Systems Development and Manufacturing Centre, Hamburg, Germany) will be included for analysis.
Cohort
Retrospective
Micro-axial flow pump support
DeviceTemporary circulatory support using the Impella 5.5 micro-axial flow pump. The device is surgically placed (typically via the axillary artery) across the aortic valve into the left ventricle to provide active forward flow, unloading the left ventricle and maintaining systemic perfusion during cardiogenic shock. Management of the device includes the collection and analysis of continuous device-derived hemodynamic data and associated clinical parameters throughout the duration of support.
Predictive Performance and Optimization of the Clinician Decision Support Tool
The predictive performance of the developed clinical decision support tool will be evaluated by its ability to classify patient trajectories toward native heart recovery versus adverse outcomes. The model will undergo comprehensive model architecture optimization to identify the structural configuration that yields optimal performance. Model training, validation, and testing will follow a standard data split: 80% of the dataset will be utilized for training and internal validation using 5-fold cross-validation, and the remaining 20% will be held out as a definitive testing dataset. Final classification performance will be quantified using specific metrics derived from Receiver Operating Characteristic (ROC) curve analysis, including: Area Under the Curve (AUC), Sensitivity, Specificity
Bias Between the Impella 5.5 Placement Signal and ICU Arterial Line Waveforms
The systematic difference (bias) between the automated Impella 5.5 optical placement signal and the gold-standard ICU indwelling arterial line pressure waveforms will be quantified using Bland-Altman analysis to evaluate signal alignment. Unit of Measure: Millimeters of mercury (mmHg)
Correlation Coefficient Between the Impella 5.5 Placement Signal and ICU Arterial Line Waveforms
The strength and direction of the linear relationship between the continuous time-series data of the Impella 5.5 optical placement signal and the ICU arterial line waveforms will be evaluated. Unit of Measure: Correlation coefficient (r) on a scale from -1.0 to 1.0.
Concordance Rate of Directional Trends Between the Impella 5.5 Placement Signal and ICU Arterial Line Waveforms
The trending ability of the placement signal will be assessed via concordance plots. The concordance rate represents the percentage of data points where the directional change (increase or decrease) matches between both signal streams over time, excluding zones of clinical noise. Unit of Measure: Percentage (%) of concordant data pairs.
Percentage of Participants Exhibiting Specific Device-Support Clinical Endpoints
The final clinical trajectory of the cohort on device support will be categorized into one of three mutually exclusive outcomes: 1. Native heart recovery (successful device weaning and explant) 2. Escalation to heart replacement therapy (durable LVAD implantation or heart transplantation) 3. All-cause mortality while on active device support. Unit of Measure: Percentage (%) of participants within each categorical outcome category.
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