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Updated feasibility trial experience with the Viaderm percutaneous access device.

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ASAIO Journal (American Society for Artificial Internal Organs : 1992)
|August 17, 2004
PubMed
Summary

The percutaneous access device (PAD) for the Kantrowitz CardioVad (KCV) heart device is stable and infection-resistant in ambulatory patients. It withstands daily manipulation, showing feasibility for chronic heart failure treatment.

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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.

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  • 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.