Driveline Heart-assisted Device Related Infection
Conditions
Keywords
HeartMate II, heart-assist device, left ventricular assist device, driveline infection, LVAD, HMII LVAS driveline, silicone portion, Thoratec Corporation
Brief summary
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)
Interventions
None listed
Sponsors
Thoratec Corporation
Abbott Medical Devices
Study design
Observational model
OTHER
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Freedom from DL infection events at 12 months after LVAD implantation | 12 Months |
Secondary
| Measure | 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 |
Countries
United States
Outcome results
None listed