A novel retroauricular fixed port for hemodialysis: surgical procedure and preliminary results of the clinical investigation.

ABSTRACT

BACKGROUND: Inspired by bone conduction implants, which have a low infection rate, a bone-anchored port (BAP) system for hemodialysis was designed. OBJECTIVES: To demonstrate the surgical procedure for the BAP and to present preliminary results of the clinical investigation. MATERIALS AND METHODS: Patients with end-stage renal disease and contraindications for an arteriovenous forearm fistula were recruited for BAP implantation. A workflow specifically developed for implantation was followed. Postoperative evolution, the dialysis procedure, the functionality of the implant, and signs of infection were monitored. RESULTS: So far, five patients have been implanted with the BAP system. Hemodialysis with the BAP was unproblematic in all five patients, on average starting from the 9th day after implantation (range 2 to 15 days). Up to now, 1789 cumulative patient days (average 355 days, range 154 to 448 days) have been recorded. One patient died 14 months after implantation, from a cardiac arrest unrelated to the system. Dialysis was painless, and no catheter-related infections have occurred. CONCLUSION: BAP implantation can be safely performed but requires an interdisciplinary team. No infections related to the device have occurred. SIGNIFICANCE: The presented system is a promising addition to the choices of vascular accesses for hemodialysis patients.