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

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Autores de IDIVAL

Autores ajenos al IDIVAL

  • 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
  • Carolis G
  • Bhatia S
  • Green M
  • Villarreal A
  • Crooks MT
  • Gwinn RP
  • Pilitsis JG
  • Sato H
  • Hillegass MG
  • Carnes P
  • Scherer C
  • Brill S
  • Yu J
  • Brennan JJ
  • Gatzinsky K
  • Navani A
  • Snook LT Jr
  • Bujedo BM
  • Andrés Ares J
  • Murillo A
  • Trobridge AT
  • Assil K
  • Shah J
  • McLeod C
  • Buwembo J
  • Coster O
  • Miller N
  • Sanapati M
  • Mikhael M
  • Przkora R
  • Sukenaga N
  • Raso LJ
  • Calodney AK
  • Cáceres Jerez LE
  • Uchiyama T
  • Kallewaard JW
  • Chandler B
  • Piedimonte F
  • Candido KD
  • Weaver TE
  • Agari T
  • Holthouse D
  • Woon R
  • Patel N
  • Lechleiter K
  • Jain R

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.

Datos de la publicación

ISSN/ISSNe:
1758-1877, 1758-1869

Pain Management  Future Medicine Ltd.

Tipo:
Article
Páginas:
115-127

Citas Recibidas en Web of Science: 15

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Keywords

  • SCS; real-world evidence; registry; safety; spinal cord stimulation

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