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| Name | Class |
|---|---|
| Eindhoven University of Technology | OTHER |
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The aim of this single center observational study is to determine the feasibility of using non-invasive imaging methods, including smartphone photography and infrared thermography, for detecting of DLIs in LVAD patients in terms of severity, extent and natural healing process.
Observational data of the driveline exit of LVAD patients will be collected during a follow-up period of 26 weeks. Two non-invasive imaging methods will be used.
Smartphone photos will be taken weekly by the patient during routine wound care in the home environment.
In case the patient is admitted for driveline infection, infrared thermographic (IRT) photography will be used to make thermographic photos of the driveline exit and the abdominal area of the subcutaneous driveline.
Furthermore, existing smartphone images and diagnostic data regarding prior DLI status will be obtained from the electronic patient records.
Imaging data will additionally be retrospectively analyzed using artificial intelligence (AI) and machine learning for the development of a predictive AI model.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients implanted with an LVAD |
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| Measure | Description | Time Frame |
|---|---|---|
| Extent and severity of driveline infections in LVAD patients using non-invasive imaging | Assess the extent, severity, and healing process of LVAD driveline infections in patients on LVAD support | 26 weeks |
| Driveline exit healing process and risk of infection of the LVAD driveline | Assess the healing process of the driveline exit using non-invasive imaging (smartphone and thermographic) | 26 |
| Measure | Description | Time Frame |
|---|---|---|
| Sceptic complications | Occurance of systemic infection, positive blood cultures, and VAD-related infections. | 26 weeks |
| Machine learning model for predicting DLIs. | Assess whether a machine learning model can be developed and validated based on smartphone photography and IRT to predict the occurrence of DLIs. |
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Inclusion Criteria: Patients age 16 years or older, implanted with an LVAD, followed at Erasmus MC, with access to a smartphone with a built-in camera, who have signed an informed consent for data collection.
Exclusion Criteria: Known cognitive problems, like dementia etc., non-cardiac disease or cardiac diseases resulting in a life expectancy less than 1 years, inability to read or sign the informed consent form.
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Patients implanted with an LVAD
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| Name | Affiliation | Role |
|---|---|---|
| K. Caliskan, MD, PhD | Erasmus Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erasmus MC | Rotterdam | Netherlands |
Imaging data will be de-identified and then shared with Eindhoven University of Technology for further analyses and modeling.
Data transfer is anticipated 1 October 2024 and 1 July 2025
Coordinating researcher V. Drost will be able to access the IPD and supporting information via the investigation site.
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| ID | Term |
|---|---|
| D007239 | Infections |
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| 26 weeks |