Scientific publications

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

Jan 24, 2023 | Magazine: Pain Management

Richard L Rauck  1 , Eric Loudermilk  2 , Simon J Thomson  3 , Jose Francisco Paz-Solis  4 , Louis Bojrab  5 , John Noles  6 , Jan Vesper  7 , Joseph Atallah  8 , Daniel Roth  9 , Joseph Hegarty  10 , Michel Prud'Homme  11 , Gregory M Phillips  12 , Stephen G Smith  13 , Mohab Ibrahim  14 , Channing D Willoughby  15 , Jon B Obray  16 , Mayank Gupta  17 , Julio Paez  18 , Anthony P Berg  19 , Nathan J Harrison  20 , Paolo Maino  21 , Praveen Mambalam  22 , Matthew McCarty  23 , Glyn Towlerton  24 , Sarah Love-Jones  25 , Shakil Ahmed  26 , Albert Lee  27 , Binit Shah  28 , Itay Goor-Aryeh  29 , Marc A Russo  30 , Nicolas Varela  31 , Jeffrey B Phelps  32 , José Cid  33 , Tacson Fernandez  34 , Concepción Pérez-Hernández  35 , Douglas Keehn  36 , Joshua M Rosenow  37 , Nameer Haider  38 , Andrew G Parrent  39 , Melinda M Lawrence  40 , Peter Georgius  41 , Laura Demartini  42 , Agustin Mendiola  43 , Vivek Mehta  44 , Reinhard Thoma  45 , Atef F Israel  46 , Giuliano De Carolis  47 , Sanjay Bhatia  48 , Matthew Green  49 , Armando Villarreal  50 , Matthew T Crooks  51 , Ryder P Gwinn  52 , Julie G Pilitsis  53 , Hitoaki Sato  54 , Sergio Maldonado Vega  55 , M Gabriel Hillegass  56 , Paul Carnes  57 , Christian Scherer  58 , Silviu Brill  59 , James Yu  60 , James J Brennan  61 , Kliment Gatzinsky  62 , Annu Navani  63 , Lee T Snook Jr  64 , Borja Mugabure Bujedo  65 , Javier De Andrés Ares  4 , Abel Murillo  66 , Andrew T Trobridge  67 , Kamyar Assil  68 , Jawad Shah  69 , Carroll McLeod  70 , Joseph Buwembo  71 , Olivier De Coster  72 , Nathan Miller  73 , Mehendra Sanapati  74 , Medhat Mikhael  75 , Rene Przkora  76 , Norihiko Sukenaga  77 , Louis J Raso  78 , Aaron K Calodney  79 , Luz Elena Cáceres Jerez  80 , Takuya Uchiyama  81 , Jan-Willem Kallewaard  82 , Brett Chandler  83 , Fabián Piedimonte  84 , Kenneth D Candido  85 , Tristan E Weaver  86 , Takashi Agari  87 , David Holthouse  88 , Rex Woon  89 , Nileshkumar Patel  89 , Kristen Lechleiter  89 , Roshini Jain  89


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.

Clinical Trial Registration: NCT01719055 (ClinicalTrials.gov).

CITATION  Pain Manag. 2023 Jan 24.  doi: 10.2217/pmt-2022-0091

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