Driveline Silicone Skin Interface Registry

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