Driveline Silicone Skin Interface Registry

Study Overview
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Brief Summary
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The purpose of this observational registry is to determine the freedom from driveline (DL) infection events in subjects implanted with a HeartMate II LVAD in whom only the silicone portion of the DL is externalized resulting in a silicone skin interface (SSI)

Official Title
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Driveline Silicone Skin Interface (SSI) Registry

Conditions
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Driveline Heart-assisted Device Related Infection

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject has signed the INTERMACS informed consent form Subject has signed the SSI registry informed consent form Subject age ≥ 18 years Subject implanted with a HeartMate II LVAD Subject in whom the full length of the velour portion of the percutaneous lead is fully kept under the skin resulting in a silicone skin interface at the skin exit site In the prospective study cohort, Subject is planned to be supported with the HeartMate II LVAD for at least 12 months In the retrospective study cohort, at the time of enrollment, Subject has been supported with a HeartMate II for at least 10 months Exclusion Criteria: In the retrospective study cohort, Subject is ongoing with long-term right heart mechanical circulatory support (RVAD) In the retrospective study cohort, Subject had a post-implant sternal re-entry (for bleeding, etc.) or delayed sternal closure In the retrospective study cohort, Subject is participating in any other clinical investigation related to driveline (DL) exit site that could confound the study results In the prospective study cohort, Subject is participating in any other clinical investigation related to driveline (DL) exit site that could confound the study results

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control Group<br>Historical control HeartMate II BTT and DT data | |
| Prospective and Retrospectively identified SSI<br>Prospectively and Retrospectively identified HeartMate II patients where the full length of the velour coated portion of the driveline is tunneled under the skin | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from DL infection events at 12 months after LVAD implantation |  | 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects with infection events |  | Month 1, 3, 6, and every six months up to 60 months post-enrollment | 
| DL infection events per patient year |  | Month 1, 3, 6, and every 6 months up to 60 months post-enrollment | 
| DL tunneling methods or other factors that might reduce risks of DL related infection events |  | Month 1, 3, 6, and every 6 months up to 60 months post-enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HeartMate II, heart-assist device, left ventricular assist device, driveline infection, LVAD, HMII LVAS driveline, silicone portion, Thoratec Corporation