Clinical Outcomes and Adverse Events Associated With Microaxial Flow Pump Support: An Explorative Retrospective Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Medical University of Vienna
- Enrollment
- 100
- Locations
- 1
Study Overview
Brief Summary
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:
- Validate the Impella 5.5 placement signal by comparing it with ICU arterial line waveforms.
- 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.
- Define clinical scenarios linked to hemolysis, HRAEs, and arrhythmias and develop predictive models to mitigate their occurrence.
Detailed Description
The clinical management of patients experiencing severe cardiogenic shock requires precise, real-time monitoring to optimize hemodynamic support and guide therapeutic transitions. The Impella 5.5 micro-axial flow pump provides left ventricular unloading, generating automated internal continuous parameters that reflect moving cardiac states. This study establishes a retrospective, longitudinal framework that integrates these high-frequency device metrics with corresponding clinical data housed within intensive care unit (ICU) digital health records (DHR). By synthesizing these disparate data streams, this research aims to build an advanced analytical framework to support clinical decisions in the cardiogenic shock landscape.
Signal Validation and Data Preprocessing:
The initial phase of the study validates the physiological fidelity of the continuous data stream. High-frequency digital logs generated by the pump console-specifically the optical placement signal-will undergo time-series alignment with standard physiological waveforms recorded in the ICU, using indwelling arterial line pressure data as the reference standard. This signal validation ensures that the longitudinal parameter data accurately capture mechanical positioning and true left ventricular dynamics prior to entering the downstream modeling pipeline.
Analytical Framework and Modeling Strategy:
Following data integration and signal validation, the consolidated dataset will be leveraged to develop predictive models aimed at distinguishing patient trajectories and forecasting complications. The computational pipeline is divided into two primary analytical pathways:
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Investigators
Thomas Schlöglhofer, PhD, MSc
Technical Director Mechanical Circulatory Support Program
Medical University of Vienna