Driveline Silicone Skin Interface Registry

Driveline Silicone Skin Interface (SSI) Registry

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)

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