Implanted Pulse Generators in Lower Extremity Neuroprostheses: A 25-Year Review

Lizbeth A Leapo; Michael E Miller; Harry A Hoyen; Gilles C Pinault; Ronald J Triolo

doi:10.1016/j.neurom.2024.03.007

Implanted Pulse Generators in Lower Extremity Neuroprostheses: A 25-Year Review

Neuromodulation. 2024 May 15:S1094-7159(24)00070-9. doi: 10.1016/j.neurom.2024.03.007. Online ahead of print.

Authors

Lizbeth A Leapo¹, Michael E Miller², Harry A Hoyen³, Gilles C Pinault⁴, Ronald J Triolo⁴

Affiliations

¹ Case Western Reserve University, Cleveland, OH, USA. Electronic address: Lizbeth.leapo@case.edu.
² Louis Stokes Cleveland Veterans Affairs Medical Center, Cleveland, OH, USA.
³ Case Western Reserve University, Cleveland, OH, USA; MetroHealth Medical Center, Cleveland, OH, USA.
⁴ Case Western Reserve University, Cleveland, OH, USA; Louis Stokes Cleveland Veterans Affairs Medical Center, Cleveland, OH, USA.

PMID: 38752947
DOI: 10.1016/j.neurom.2024.03.007

Abstract

Objectives: Neuroprosthetic devices can improve quality of life by providing an alternative option for motor function lost after spinal cord injury, stroke, and other central nervous system disorders. The objective of this study is to analyze the outcomes of implanted pulse generators that our research group installed in volunteers with paralysis to assist with lower extremity function over a 25-year period, specifically, to determine survival rates and common modes of malfunction, reasons for removal or revision, and precipitating factors or external events that may have adversely influenced device performance.

Materials and methods: Our implantable receiver-stimulator (IRS-8) and implantable stimulator-telemeter (IST-12 and IST-16) device histories were retrospectively reviewed through surgical notes, regulatory documentation, and manufacturing records from 1996 to 2021.

Results: Most of the 65 devices (64.6%) implanted in 43 volunteers remain implanted and operational. Seven underwent explantation owing to infection; seven had internal failures, and six were physically broken by external events. Of the 22 devices explanted, 15 were successfully replaced to restore recipients' enhanced functionality. There were no instances of sepsis or major health complications. The five infections that followed all 93 IRS and IST lower extremity research surgeries during this period indicate a pooled infection rate of 5.4%. The Kaplan-Meier analysis of technical malfunctions between the implant date and most recent follow-up shows five-, ten-, and 20-year device survival rates of 92%, 84%, and 71%, respectively.

Conclusions: Incidence of malfunction is similar to, whereas infection rates are slightly higher than, other commonly implanted medical devices. Future investigations will focus on infection prevention, modifying techniques on the basis of recipient demographics, lifestyle factors, and education, and integrating similar experience of motor neuroprostheses used in other applications.

Keywords: Implanted devices; neuroprosthesis; neurostimulation; rehabilitation; spinal cord injury.