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.

Does Total Implantability Reduce Infection With the Use of a Left Ventricular Assist Device? The LionHeart Experience in Europe

“…In recent research, autologous fibroblasts have been added to drive-lines to suppress this altered epithelialization, and this has been successful in preventing infection in a limited number of patients. 19 However, removal of the percutaneous conduit may be a better alternative.…”

A mouse model to evaluate the interface between skin and a percutaneous device

“…Percutaneous devices play a vital role in modern medicine, having been successfully integrated in applications such as implanted cardiac assist devices and bone‐anchored hearing aids 11, 12. However, their use has been limited in other medical applications because of their substantial risk of infection.…”

“…Percutaneous devices play a vital role in modern medicine, having been successfully integrated in applications such as implanted cardiac assist devices and bone-anchored hearing aids. 11,12 However, their use has been limited in other medical applications because of their substantial risk of infection. Over 20 years ago, von Recum reviewed the four primary complications associated with percutaneous devices: marsupialization (creating a pouch), permigration (the epidermis follows the remodeling connective tis- sue into the pores and then extrudes the percutaneous implant), infection, and avulsion (trauma causing the device to be torn away from the skin).…”

Improving skin integration around long‐term percutaneous devices using fibrous scaffolds in a reconstructed human skin equivalent model

“…This work was pioneered by Kantrowitz and coworkers in the 1980s, based on the hypothesis that the fibroblasts will form a dense collagen network, hindering epithelial downgrowth (Kantrowitz et al, ), that is, epidermal migration parallel to the percutaneous device into the dermis, in an attempt to restore epithelial continuity (von Recum, ). The resulting percutaneous access device technology consists of a polycarbonate conical neck and silicone disk anchor covered in a Dacron fabric with heterogeneous porosity and has successfully been implanted in patients as part of a clinical trial for the Kantrowitz CardioVAD cardiac assist device reported in 2014 (Gesler et al, ). The observed episodes of infections in two patients were not linked to the device–tissue interface.…”

“…The resulting percutaneous access device technology consists of a polycarbonate conical neck and silicone disk anchor covered in a Dacron fabric with heterogeneous porosity and has successfully been implanted in patients as part of a clinical trial for the Kantrowitz Cardio-VAD cardiac assist device reported in 2014 (Gesler et al, 2004). The observed episodes of infections in two patients were not linked to the device-tissue interface.…”