Remote Management of Spinal Cord Stimulation Devices for Chronic Pain: Expert Recommendations on Best Practices for Proper Utilization and Future Considerations.

Emerging spinal cord stimulation (SCS) remote monitoring and programming technologies provide a unique opportunity to address challenges of in-person visits and improve patient care, although clinical guidance on implementation is needed. The goal of this document is to establish best clinical practices for integration of remote device management into the care of patients with SCS, including remote monitoring and remote programming. A panel of experts in SCS met in July 2022, and additional experts contributed to the development of recommendations after the meeting via survey responses and correspondence. Major goals of remote SCS device management were identified, including prompt identification and resolution of SCS-related issues. The panel identified metrics for remote monitoring and classified them into three categories: device-related (eg, stimulation usage); measurable physiologic or disease-related (eg, patient physical activity or pedometry); and patient-reported (eg, sleep quality and pain intensity). Recommendations were made for frequency of reviewing remote monitoring metrics, although providers should tailor follow-up to individual patient needs. Such periodic reviews of remote monitoring metrics would occur separately from automatic monitoring system notifications (if key metrics fall outside an acceptable range). The guidelines were developed in consideration of reimbursement processes, privacy concerns, and the responsibilities of the care team, industry professionals, manufacturers, patients, and caregivers. Both existing and needed clinical evidence were covered, including outcomes of interest for future studies. Given the expansion of SCS device capabilities, this document provides critical guidance on best practices for using remote device management, although medical necessity should drive all remote monitoring decisions, with individualized patient care. The authors also describe the potential of these emerging technologies to improve outcomes for patients with SCS, although more clinical evidence is needed.

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Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.

Déclaration de conflit d'intérêts

Conflict of Interest Peter Staats has received consulting and research grants from Medtronic, Boston Scientific, Nevro, Abbott, Biotronik, Nalu, Saluda, and Vertos, receives royalties from Averitas, and is the founder and CMO of electroCore. Timothy R. Deer is a consultant for Abbott, Saluda, Nalu, and Medtronic, a research investigator for Abbott, Saluda, and Mainstay, has stock options with Saluda and Nalu, and has a patent pending with Abbott for dorsal root ganglion surgical leads. Corey Hunter has consulted for Abbott, Biotronik, Mainstay, Nalu, PainTEQ, Saluda, and Vertos, served as a research investigator for Abbott, Saluda, Biotronik, Mesoblast, Discgenics, Vivex, TissueGene, FusMobile, Averitas, and Mainstay, and has stock options with Mainstay, Nalu, PainTEQ, Vivex and Vertos. Sean Li has consulted for Nevro (research grant), Boston Scientific (research grant), Saluda (research grant), Abbott, Avanos (research grant), Vertos, Nalu (research grant, shareholder), PainTeq (research grant), Averitas Pharma (research grant), SPR Therapeutics (research grant), and Biotronik (research grant), has received a research grant from SGX Medical, and has served on advisory boards for Saluda and Vertos and on a speaker bureau for Scilex Pharma. David Dickerson has received speaking and consulting fees from SPR Therapeutics (research grant), Pfizer, Myovant, Abbott (research grant), Vertos, Nalu, and Biotronik. Erika Petersen has received research support from Mainstay, Medtronic, Nalu, Neuros Medical, Nevro Corp, ReNeuron, SPR, and Saluda, in addition to personal fees from Abbott Neuromodulation, Biotronik, Medtronic Neuromodulation, Nalu, Neuros Medical, Nevro, Presidio Medical, Saluda, and Vertos. She holds stock options from SynerFuse and neuro42. Leonardo Kapural has consulted for Nevro, Abbott, Medtronic, Nalu, Saluda, and Biotronik and participated in research for Nevro, Medtronic, Gimer Medical, Neuros, Saluda, Biotronik, and SPR Therapeutics. Shravani Durbhakula has consulted for Averitas Pharma. She is a shareholder of Patient Premier, Inc. Christopher Gilligan is the editor-in-chief of Pain Practice and has consulted for Mainstay Medical, Saluda, Persica, and Iliad Lifesciences. Konstantin V. Slavin reports institutional grants and consulting income from Medtronic, Abbott, Boston Scientific, Neuros, Integer, Biotronik, and WISE, and minor ownership of Neuramodix, Thermaquil, Vycor Medical and Higgs Boson. Jason Pope serves as a consultant for Abbott, Medtronic, Saluda, Flowonix, SpineThera, Painteq, Vertos, Vertiflex, SPR Therapeutics, Tersera, Aurora, Spark, Ethos, Biotronik, Mainstay, WISE, Boston Scientific, and Thermaquil and has received grant and research support from Abbott, Flowonix, Saluda, Aurora, Painteq, Ethos, Muse, Boston Scientific, SPR Therapeutics, Mainstay, Vertos, AIS, and Thermaquil. Kasra Amirdelfan has consulted for Medtronic, Boston Scientific, Nevro, Biotronik, and Nalu (minor options). Lawrence Poree has consulted for Medtronic, Nalu, and Saluda. Ramana Naidu has served on Speakers Bureau for Abbott, Avanos, Boston Scientific, and Nalu, as a consultant for Abbott, Biotronik, Bioventus, Boston Scientific, Medtronic, Nalu, SPR Therapeutics, and Avanos, on an advisory/medical board for Abbott, Boston Scientific, Nalu, and SPR Therapeutics, and as an investigator for Abbott and Boston Scientific. Robert M. Levy is an unpaid consultant for Saluda, Nalu, and Mainstay Medical.