Updated feasibility trial experience with the Viaderm percutaneous access device

Area of Science:

• Biomedical Engineering
• Cardiovascular Science
• Medical Devices

Background:

• Chronic heart failure necessitates advanced cardiac assist devices.
• The Kantrowitz CardioVad (KCV) is a cardiac assist device requiring external connections.
• Percutaneous access devices (PADs) are crucial for connecting external units to implanted devices.

Purpose of the Study:

• To evaluate the feasibility and safety of the percutaneous access device (PAD) for the Kantrowitz CardioVad (KCV).
• To assess the stability, infection resistance, and durability of the PAD in patients with chronic heart failure.

Main Methods:

• The PAD device-tissue interface was precoated with autologous fibroblasts.
• The PAD was implanted in nine patients (ages 41-74) receiving the KCV.
• Patient data on implant duration, outpatient use, and complications were collected.

Main Results:

• The PAD demonstrated long-term stability and infection resistance in ambulatory patients.
• The device withstood frequent daily manipulation associated with KCV use.
• Two infections occurred, neither originating from the PAD-tissue interface.

Conclusions:

• The PAD is a stable and infection-resistant interface for the KCV cardiac assist device.
• The PAD is suitable for long-term use and daily patient manipulation.
• PADs can be safely replaced if necessary, supporting KCV therapy.