Updated feasibility trial experience with the Viaderm percutaneous access device.

Abstract

The percutaneous access device (PAD) is used to connect an external drive unit to the Kantrowitz CardioVad (KCV), a cardiac assist device for the treatment of chronic heart failure. The PAD conveys pneumatic power from a drive unit to the implanted blood pump and an electrocardiogram signal from the myocardium to the drive unit. The device-tissue interface of the PAD is precoated with autologous fibroblasts cultured from a skin sample of the intended recipient. This preparation demonstrated long-term stability in animals and was adopted for use in patients receiving the KCV. The KCV is activated intermittently, and the drive unit may be connected and disconnected by the patient, which subjects the PAD to frequent manipulation. To date, the PAD has been implanted in nine patients ranging in age from 41 to 74 years. Implant times ranged from 2 to 458 days, for a total of 1082 days, of which 557 days were in an outpatient setting. Two patients experienced episodes of infection that did not originate from the PAD-tissue interface. This feasibility study demonstrated that (1) the PAD is stable and infection resistant in long-term ambulatory patients, (2) the PAD withstood the challenge of daily manipulation (the KCV is turned on and off electively), and (3) PADs can be replaced, if necessary.