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.

Chinese abstract

背景：受低感染率骨传导植入体的启发, 一种血液透析用骨锚定端口（BAP）系统被设计出来。

目的：显现BAP的手术方法, 并提供临床研究的初步结果。

材料与方法：招入终末期肾病患者及动静脉前臂瘘禁忌症患者以进行BAP植入。遵循专门为植入而建立的工作流程。监测术后进展、透析程序、植入体功能和感染迹象。

结果：目前已有5例患者植入BAP系统。从植入后平均第9天（范围为2至15天）开始, 5名患者的BAP血液透析均未出现问题。到目前为止, 已记录1789个累计患者天数（平均355天, 范围154至448天）。一名患者在植入14个月之后死于与本系统无关的心脏骤停。透析是无痛的, 没有发生导管相关的感染。

结论：BAP植入术安全可行, 但需要一个跨学科的团队。未发生与设备相关的感染。

意义：该系统是血液透析病人血管通路选择的一个有前景的分子。

Keywords:

• Bone-anchored port
• chronic renal failure
• hemodialysis
• implant surgery

Acknowledgments

This work was presented at the Collegium ORL Amicitiae Sacrum annual meeting, September 16-19, 2018 in Beijing, China. The authors would like to acknowledge Gianni Pauciello for the intra- and postoperative photography presented in this work, as well Thomas Frei for the technical support from Diavantis (Cendres Métaux, Bienne, Switzerland).

Disclosure statement

Caversaccio MD, Häusler R, Uehlinger DE, Arnold A are mentioned as inventors on related patents. Arnold A and Widmer M are contracted as consultants for development and training with Diavantis SA. The authors alone are responsible for the content and writing of the paper.

Additional information

Funding

This work received funding from the Swiss Commission for Technology and Innovation [CTI-Grants No. 9952, 12593 and 13753].