Long-term safety of spinal cord stimulation systems in a prospective, global registry of patients with chronic pain

Richard L. Rauck; Eric Loudermilk; Simon J. Thomson; Jose Francisco Paz-Solis; Louis Bojrab; John Noles; Jan Vesper; Joseph Atallah; Daniel Roth; Joseph Hegarty; Michel Prud'homme; Gregory M. Phillips; Stephen G. Smith; Mohab Ibrahim; Channing D. Willoughby; Jon B. Obray; Mayank Gupta; Julio Paez; Anthony P. Berg; Nathan J. Harrison; Paolo Maino; Praveen Mambalam; Matthew McCarty; Glyn Towlerton; Sarah Love-Jones; Shakil Ahmed; Albert Lee; Binit Shah; Itay Goor-Aryeh; Marc A. Russo; Nicolas Varela; Jeffrey B. Phelps; José Cid; Tacson Fernandez; Concepción Pérez-Hernández; Douglas Keehn; Joshua M. Rosenow; Nameer Haider; Andrew G. Parrent; Melinda M. Lawrence; Peter Georgius; Laura Demartini; Agustin Mendiola; Vivek Mehta; Reinhard Thoma; Atef F. Israel; Giuliano De Carolis; Sanjay Bhatia; Matthew Green; Armando Villarreal; Matthew T. Crooks; Ryder P. Gwinn; Julie G. Pilitsis; Hitoaki Sato; Sergio Maldonado Vega; M. Gabriel Hillegass; Paul Carnes; Christian Scherer; Silviu Brill; James Yu; James J. Brennan; Kliment Gatzinsky; Annu Navani; Lee T. Snook; Borja Mugabure Bujedo; Javier De Andrés Ares; Abel Murillo; Andrew T. Trobridge; Kamyar Assil; Jawad Shah; Carroll McLeod; Joseph Buwembo; Olivier De Coster; Nathan Miller; Mehendra Sanapati; Medhat Mikhael; Rene Przkora; Norihiko Sukenaga; Louis J. Raso; Aaron K. Calodney; Luz Elena Cáceres Jerez; Takuya Uchiyama; Jan Willem Kallewaard; Brett Chandler; Fabián Piedimonte; Kenneth D. Candido; Tristan E. Weaver; Takashi Agari; David Holthouse; Rex Woon; Nileshkumar Patel; Kristen Lechleiter; Roshini Jain

doi:10.2217/pmt-2022-0091

Long-term safety of spinal cord stimulation systems in a prospective, global registry of patients with chronic pain

Richard L. Rauck
, Eric Loudermilk
, Simon J. Thomson
, Jose Francisco Paz-Solis
, Louis Bojrab
, John Noles
, Jan Vesper
, Joseph Atallah
, Daniel Roth
, Joseph Hegarty
, Michel Prud'homme
, Gregory M. Phillips
, Stephen G. Smith
, Mohab Ibrahim
, Channing D. Willoughby
, Jon B. Obray
, Mayank Gupta
, Julio Paez
, Anthony P. Berg
, Nathan J. Harrison

Paolo Maino, Praveen Mambalam, Matthew McCarty, Glyn Towlerton, Sarah Love-Jones, Shakil Ahmed, Albert Lee, Binit Shah, Itay Goor-Aryeh, Marc A. Russo, Nicolas Varela, Jeffrey B. Phelps, José Cid, Tacson Fernandez, Concepción Pérez-Hernández, Douglas Keehn, Joshua M. Rosenow, Nameer Haider, Andrew G. Parrent, Melinda M. Lawrence, Peter Georgius, Laura Demartini, Agustin Mendiola, Vivek Mehta, Reinhard Thoma, Atef F. Israel, Giuliano De Carolis, Sanjay Bhatia, Matthew Green, Armando Villarreal, Matthew T. Crooks, Ryder P. Gwinn, Julie G. Pilitsis, Hitoaki Sato, Sergio Maldonado Vega, M. Gabriel Hillegass, Paul Carnes, Christian Scherer, Silviu Brill, James Yu, James J. Brennan, Kliment Gatzinsky, Annu Navani, Lee T. Snook, Borja Mugabure Bujedo, Javier De Andrés Ares, Abel Murillo, Andrew T. Trobridge, Kamyar Assil, Jawad Shah, Carroll McLeod, Joseph Buwembo, Olivier De Coster, Nathan Miller, Mehendra Sanapati, Medhat Mikhael, Rene Przkora, Norihiko Sukenaga, Louis J. Raso, Aaron K. Calodney, Luz Elena Cáceres Jerez, Takuya Uchiyama, Jan Willem Kallewaard, Brett Chandler, Fabián Piedimonte, Kenneth D. Candido, Tristan E. Weaver, Takashi Agari, David Holthouse, Rex Woon, Nileshkumar Patel, Kristen Lechleiter, Roshini Jain

Research output: Contribution to journal › Article › peer-review

27 Scopus citations

Abstract

Aim: The availability of long-term (>2 years) safety outcomes of spinal cord stimulation (SCS) remains limited. We evaluated safety in a global SCS registry for chronic pain. Methods: Participants were prospectively enrolled globally at 79 implanting centers and followed out to 3 years after device implantation. Results: Of 1881 participants enrolled, 1289 received a permanent SCS implant (1776 completed trial). The annualized rate of device explant was 3.5% (all causes), and 1.1% due to inadequate pain relief. Total incidence of device explantation >3 years was 7.6% (n = 98). Of these, 32 subjects (2.5%) indicated inadequate pain relief as cause for removal. Implant site infection (11 events) was the most common device-related serious adverse event (<1%). Conclusion: This prospective, global, real-world study demonstrates a high-level of safety for SCS with low rate of explant/serious adverse events.

Original language	English (US)
Pages (from-to)	115-127
Number of pages	13
Journal	Pain Management
Volume	13
Issue number	2
DOIs	https://doi.org/10.2217/pmt-2022-0091
State	Published - Feb 1 2023
Externally published	Yes

Keywords

SCS
real-world evidence
registry
safety
spinal cord stimulation

ASJC Scopus subject areas

Anesthesiology and Pain Medicine

Access to Document

10.2217/pmt-2022-0091

Cite this

Rauck, R. L., Loudermilk, E., Thomson, S. J., Paz-Solis, J. F., Bojrab, L., Noles, J., Vesper, J., Atallah, J., Roth, D., Hegarty, J., Prud'homme, M., Phillips, G. M., Smith, S. G., Ibrahim, M., Willoughby, C. D., Obray, J. B., Gupta, M., Paez, J., Berg, A. P., ... Jain, R. (2023). Long-term safety of spinal cord stimulation systems in a prospective, global registry of patients with chronic pain. Pain Management, 13(2), 115-127. https://doi.org/10.2217/pmt-2022-0091

Rauck, RL, Loudermilk, E, Thomson, SJ, Paz-Solis, JF, Bojrab, L, Noles, J, Vesper, J, Atallah, J, Roth, D, Hegarty, J, Prud'homme, M, Phillips, GM, Smith, SG, Ibrahim, M, Willoughby, CD, Obray, JB, Gupta, M, Paez, J, Berg, AP, Harrison, NJ, Maino, P, Mambalam, P, McCarty, M, Towlerton, G, Love-Jones, S, Ahmed, S, Lee, A, Shah, B, Goor-Aryeh, I, Russo, MA, Varela, N, Phelps, JB, Cid, J, Fernandez, T, Pérez-Hernández, C, Keehn, D, Rosenow, JM, Haider, N, Parrent, AG, Lawrence, MM, Georgius, P, Demartini, L, Mendiola, A, Mehta, V, Thoma, R, Israel, AF, De Carolis, G, Bhatia, S, Green, M, Villarreal, A, Crooks, MT, Gwinn, RP, Pilitsis, JG, Sato, H, Vega, SM, Gabriel Hillegass, M, Carnes, P, Scherer, C, Brill, S, Yu, J, Brennan, JJ, Gatzinsky, K, Navani, A, Snook, LT, Bujedo, BM, De Andrés Ares, J, Murillo, A, Trobridge, AT, Assil, K, Shah, J, McLeod, C, Buwembo, J, De Coster, O, Miller, N, Sanapati, M, Mikhael, M, Przkora, R, Sukenaga, N, Raso, LJ, Calodney, AK, Jerez, LEC, Uchiyama, T, Kallewaard, JW, Chandler, B, Piedimonte, F, Candido, KD, Weaver, TE, Agari, T, Holthouse, D, Woon, R, Patel, N, Lechleiter, K & Jain, R 2023, 'Long-term safety of spinal cord stimulation systems in a prospective, global registry of patients with chronic pain', Pain Management, vol. 13, no. 2, pp. 115-127. https://doi.org/10.2217/pmt-2022-0091

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title = "Long-term safety of spinal cord stimulation systems in a prospective, global registry of patients with chronic pain",

abstract = "Aim: The availability of long-term (>2 years) safety outcomes of spinal cord stimulation (SCS) remains limited. We evaluated safety in a global SCS registry for chronic pain. Methods: Participants were prospectively enrolled globally at 79 implanting centers and followed out to 3 years after device implantation. Results: Of 1881 participants enrolled, 1289 received a permanent SCS implant (1776 completed trial). The annualized rate of device explant was 3.5\% (all causes), and 1.1\% due to inadequate pain relief. Total incidence of device explantation >3 years was 7.6\% (n = 98). Of these, 32 subjects (2.5\%) indicated inadequate pain relief as cause for removal. Implant site infection (11 events) was the most common device-related serious adverse event (<1\%). Conclusion: This prospective, global, real-world study demonstrates a high-level of safety for SCS with low rate of explant/serious adverse events.",

keywords = "SCS, real-world evidence, registry, safety, spinal cord stimulation",

author = "Rauck, \{Richard L.\} and Eric Loudermilk and Thomson, \{Simon J.\} and Paz-Solis, \{Jose Francisco\} and Louis Bojrab and John Noles and Jan Vesper and Joseph Atallah and Daniel Roth and Joseph Hegarty and Michel Prud'homme and Phillips, \{Gregory M.\} and Smith, \{Stephen G.\} and Mohab Ibrahim and Willoughby, \{Channing D.\} and Obray, \{Jon B.\} and Mayank Gupta and Julio Paez and Berg, \{Anthony P.\} and Harrison, \{Nathan J.\} and Paolo Maino and Praveen Mambalam and Matthew McCarty and Glyn Towlerton and Sarah Love-Jones and Shakil Ahmed and Albert Lee and Binit Shah and Itay Goor-Aryeh and Russo, \{Marc A.\} and Nicolas Varela and Phelps, \{Jeffrey B.\} and Jos{\'e} Cid and Tacson Fernandez and Concepci{\'o}n P{\'e}rez-Hern{\'a}ndez and Douglas Keehn and Rosenow, \{Joshua M.\} and Nameer Haider and Parrent, \{Andrew G.\} and Lawrence, \{Melinda M.\} and Peter Georgius and Laura Demartini and Agustin Mendiola and Vivek Mehta and Reinhard Thoma and Israel, \{Atef F.\} and \{De Carolis\}, Giuliano and Sanjay Bhatia and Matthew Green and Armando Villarreal and Crooks, \{Matthew T.\} and Gwinn, \{Ryder P.\} and Pilitsis, \{Julie G.\} and Hitoaki Sato and Vega, \{Sergio Maldonado\} and \{Gabriel Hillegass\}, M. and Paul Carnes and Christian Scherer and Silviu Brill and James Yu and Brennan, \{James J.\} and Kliment Gatzinsky and Annu Navani and Snook, \{Lee T.\} and Bujedo, \{Borja Mugabure\} and \{De Andr{\'e}s Ares\}, Javier and Abel Murillo and Trobridge, \{Andrew T.\} and Kamyar Assil and Jawad Shah and Carroll McLeod and Joseph Buwembo and \{De Coster\}, Olivier and Nathan Miller and Mehendra Sanapati and Medhat Mikhael and Rene Przkora and Norihiko Sukenaga and Raso, \{Louis J.\} and Calodney, \{Aaron K.\} and Jerez, \{Luz Elena C{\'a}ceres\} and Takuya Uchiyama and Kallewaard, \{Jan Willem\} and Brett Chandler and Fabi{\'a}n Piedimonte and Candido, \{Kenneth D.\} and Weaver, \{Tristan E.\} and Takashi Agari and David Holthouse and Rex Woon and Nileshkumar Patel and Kristen Lechleiter and Roshini Jain",

note = "Publisher Copyright: {\textcopyright} 2023 The Authors.",

year = "2023",

month = feb,

day = "1",

doi = "10.2217/pmt-2022-0091",

language = "English (US)",

volume = "13",

pages = "115--127",

journal = "Pain Management",

issn = "1758-1869",

publisher = "Taylor and Francis Ltd.",

number = "2",

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TY - JOUR

T1 - Long-term safety of spinal cord stimulation systems in a prospective, global registry of patients with chronic pain

AU - Rauck, Richard L.

AU - Loudermilk, Eric

AU - Thomson, Simon J.

AU - Paz-Solis, Jose Francisco

AU - Bojrab, Louis

AU - Noles, John

AU - Vesper, Jan

AU - Atallah, Joseph

AU - Roth, Daniel

AU - Hegarty, Joseph

AU - Prud'homme, Michel

AU - Phillips, Gregory M.

AU - Smith, Stephen G.

AU - Ibrahim, Mohab

AU - Willoughby, Channing D.

AU - Obray, Jon B.

AU - Gupta, Mayank

AU - Paez, Julio

AU - Berg, Anthony P.

AU - Harrison, Nathan J.

AU - Maino, Paolo

AU - Mambalam, Praveen

AU - McCarty, Matthew

AU - Towlerton, Glyn

AU - Love-Jones, Sarah

AU - Ahmed, Shakil

AU - Lee, Albert

AU - Shah, Binit

AU - Goor-Aryeh, Itay

AU - Russo, Marc A.

AU - Varela, Nicolas

AU - Phelps, Jeffrey B.

AU - Cid, José

AU - Fernandez, Tacson

AU - Pérez-Hernández, Concepción

AU - Keehn, Douglas

AU - Rosenow, Joshua M.

AU - Haider, Nameer

AU - Parrent, Andrew G.

AU - Lawrence, Melinda M.

AU - Georgius, Peter

AU - Demartini, Laura

AU - Mendiola, Agustin

AU - Mehta, Vivek

AU - Thoma, Reinhard

AU - Israel, Atef F.

AU - De Carolis, Giuliano

AU - Bhatia, Sanjay

AU - Green, Matthew

AU - Villarreal, Armando

AU - Crooks, Matthew T.

AU - Gwinn, Ryder P.

AU - Pilitsis, Julie G.

AU - Sato, Hitoaki

AU - Vega, Sergio Maldonado

AU - Gabriel Hillegass, M.

AU - Carnes, Paul

AU - Scherer, Christian

AU - Brill, Silviu

AU - Yu, James

AU - Brennan, James J.

AU - Gatzinsky, Kliment

AU - Navani, Annu

AU - Snook, Lee T.

AU - Bujedo, Borja Mugabure

AU - De Andrés Ares, Javier

AU - Murillo, Abel

AU - Trobridge, Andrew T.

AU - Assil, Kamyar

AU - Shah, Jawad

AU - McLeod, Carroll

AU - Buwembo, Joseph

AU - De Coster, Olivier

AU - Miller, Nathan

AU - Sanapati, Mehendra

AU - Mikhael, Medhat

AU - Przkora, Rene

AU - Sukenaga, Norihiko

AU - Raso, Louis J.

AU - Calodney, Aaron K.

AU - Jerez, Luz Elena Cáceres

AU - Uchiyama, Takuya

AU - Kallewaard, Jan Willem

AU - Chandler, Brett

AU - Piedimonte, Fabián

AU - Candido, Kenneth D.

AU - Weaver, Tristan E.

AU - Agari, Takashi

AU - Holthouse, David

AU - Woon, Rex

AU - Patel, Nileshkumar

AU - Lechleiter, Kristen

AU - Jain, Roshini

PY - 2023/2/1

Y1 - 2023/2/1

N2 - Aim: The availability of long-term (>2 years) safety outcomes of spinal cord stimulation (SCS) remains limited. We evaluated safety in a global SCS registry for chronic pain. Methods: Participants were prospectively enrolled globally at 79 implanting centers and followed out to 3 years after device implantation. Results: Of 1881 participants enrolled, 1289 received a permanent SCS implant (1776 completed trial). The annualized rate of device explant was 3.5% (all causes), and 1.1% due to inadequate pain relief. Total incidence of device explantation >3 years was 7.6% (n = 98). Of these, 32 subjects (2.5%) indicated inadequate pain relief as cause for removal. Implant site infection (11 events) was the most common device-related serious adverse event (<1%). Conclusion: This prospective, global, real-world study demonstrates a high-level of safety for SCS with low rate of explant/serious adverse events.

AB - Aim: The availability of long-term (>2 years) safety outcomes of spinal cord stimulation (SCS) remains limited. We evaluated safety in a global SCS registry for chronic pain. Methods: Participants were prospectively enrolled globally at 79 implanting centers and followed out to 3 years after device implantation. Results: Of 1881 participants enrolled, 1289 received a permanent SCS implant (1776 completed trial). The annualized rate of device explant was 3.5% (all causes), and 1.1% due to inadequate pain relief. Total incidence of device explantation >3 years was 7.6% (n = 98). Of these, 32 subjects (2.5%) indicated inadequate pain relief as cause for removal. Implant site infection (11 events) was the most common device-related serious adverse event (<1%). Conclusion: This prospective, global, real-world study demonstrates a high-level of safety for SCS with low rate of explant/serious adverse events.

KW - SCS

KW - real-world evidence

KW - registry

KW - safety

KW - spinal cord stimulation

UR - https://www.scopus.com/pages/publications/85147868383

UR - https://www.scopus.com/pages/publications/85147868383#tab=citedBy

U2 - 10.2217/pmt-2022-0091

DO - 10.2217/pmt-2022-0091

M3 - Article

C2 - 36691862

AN - SCOPUS:85147868383

SN - 1758-1869

VL - 13

SP - 115

EP - 127

JO - Pain Management

JF - Pain Management

IS - 2

ER -

Long-term safety of spinal cord stimulation systems in a prospective, global registry of patients with chronic pain

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Keywords

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