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。
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.