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

Author:

Rauck Richard L1,Loudermilk Eric2,Thomson Simon J3,Paz-Solis Jose Francisco4,Bojrab Louis5,Noles John6,Vesper Jan7,Atallah Joseph8,Roth Daniel9,Hegarty Joseph10,Prud'Homme Michel11,Phillips Gregory M12,Smith Stephen G13,Ibrahim Mohab14,Willoughby Channing D15,Obray Jon B16,Gupta Mayank17,Paez Julio18,Berg Anthony P19,Harrison Nathan J20,Maino Paolo21,Mambalam Praveen22,McCarty Matthew23,Towlerton Glyn24,Love-Jones Sarah25,Ahmed Shakil26,Lee Albert27,Shah Binit28,Goor-Aryeh Itay29,Russo Marc A30,Varela Nicolas31,Phelps Jeffrey B32,Cid José33,Fernandez Tacson34,Pérez-Hernández Concepción35,Keehn Douglas36,Rosenow Joshua M37,Haider Nameer38,Parrent Andrew G39,Lawrence Melinda M40,Georgius Peter41,Demartini Laura42,Mendiola Agustin43,Mehta Vivek44,Thoma Reinhard45,Israel Atef F46,Carolis Giuliano De47,Bhatia Sanjay48,Green Matthew49,Villarreal Armando50,Crooks Matthew T51,Gwinn Ryder P52,Pilitsis Julie G53,Sato Hitoaki54,Vega Sergio Maldonado55,Hillegass M. Gabriel56,Carnes Paul57,Scherer Christian58,Brill Silviu59,Yu James60,Brennan James J61,Gatzinsky Kliment62,Navani Annu63,Snook Jr Lee T64,Bujedo Borja Mugabure65,Andrés Ares Javier De4,Murillo Abel66,Trobridge Andrew T67,Assil Kamyar68,Shah Jawad69,McLeod Carroll70,Buwembo Joseph71,Coster Olivier De72,Miller Nathan73,Sanapati Mehendra74,Mikhael Medhat75,Przkora Rene76,Sukenaga Norihiko77,Raso Louis J78,Calodney Aaron K79,Cáceres Jerez Luz Elena80,Uchiyama Takuya81,Kallewaard Jan-Willem82,Chandler Brett83,Piedimonte Fabián84,Candido Kenneth D85,Weaver Tristan E86,Agari Takashi87,Holthouse David88,Woon Rex89,Patel Nileshkumar89,Lechleiter Kristen89,Jain Roshini89

Affiliation:

1. Carolinas Pain Institute & The Center for Clinical Research LLC, Winston-Salem, NC 27103, USA

2. PCPMG Clinical Research Unit LLC, Anderson, SC 29621, USA

3. Mid & South Essex University Hospitals, Basildon, Essex, SS16 5NL, United Kingdom

4. University Hospital La Paz, Madrid, 28046, Spain

5. Forest Health Medical Center, Ypsilanti, MI 48198, USA

6. Spine & Pain Specialists, Shreveport, LA 71105, USA

7. University Hospital Düsseldorf, Düsseldorf, 40225, Germany

8. The Toledo Clinic, Toledo, OH 43606, USA

9. Summit Pain Management, Fort Wayne, IN 46804, USA

10. Optim Health System – Tattnall Hospital, Reidsville, GA 30453, USA

11. CHU de Québec – Université Laval, Quebec City, QC, G1L 3L5, Canada

12. Pacific Sports & Spine, Eugene, OR 97401, USA

13. Ramos Center for Interventional & Functional Pain Medicine, Englewood, FL 34205, USA

14. University of Arizona, Banner Health – University Medical Center, Tucson, AZ 85719, USA

15. Carolina Orthopaedic & Neurological Associates, Greenville, SC 29615, USA

16. Southwest Spine & Pain Center, St George, UT 84790, USA

17. Kansas Pain Management & Neuroscience Research Center, LLC, Overland Park, KS 66210, USA

18. Southlake Pain Institute, Clermont, FL 34711, USA

19. Spine Team Texas, Rockwall, TX 75032, USA

20. Ochsner Health Center, Covington, LA 70433, USA

21. Neurocenter of Southern Switzerland, Ospedale Regionale di Lugano, Lugano, 6900, Switzerland

22. Washington Center for Pain Management, Bellevue, WA 98372, USA

23. Balcones Pain Consultants, Austin, TX 78749, USA

24. Chelsea & Westminster Hospitals, London, SW10 9NH, United Kingdom

25. Southmead Hospital, Bristol, BS10 5NB, United Kingdom

26. Weill Cornell Medicine, Center for Comprehensive Spine Care, New York City, NY 10022, USA

27. Tallahassee Neurological Clinic, Tallahassee, FL 32308, USA

28. Carolinas Pain Center, Charlotte, NC 28262, USA

29. Pain Medicine Institute, Sheba Medical Center, Ramat Gan, 52621, Israel

30. Hunter Pain Specialists, Broadmeadow, New South Wales, 2292, Australia

31. Clínica Universidad de Navarra, Pamplona, 31008, Spain

32. Spine Works Institute, North Richland Hills, TX 76182, USA

33. Toledo University Hospital Complex, Toledo, 45004, Spain

34. Royal National Orthopaedic Hospital, NHS Trust, Stanmore, Middlesex, HA7 4LP, United Kingdom

35. Hospital Universitario de La Princesa, Madrid, 28006, Spain

36. Pain Centers of Wisconsin, Fort Atkinson, WI 53220, USA

37. Northwestern University Feinberg School of Medicine, Chicago, IL 60611, USA

38. APMR Spinal & Skeletal Pain Medicine, Utica, NY 13502, USA

39. London Health Sciences Centre, Western University, London, ON, N6A 5W9, Canada

40. Case Western Reserve University, Cleveland, OH 44106, USA

41. Sunshine Coast Clinical Research, Noosa Heads, Queensland, 4567, Australia

42. Fondazione Salvatore Maugeri IRCCS, Pavia, 27100, Italy

43. Puerta de Hierro University Hospital, Boadilla del Monte, 28222, Spain

44. St. Bartholomew's Hospital, London, EC1A 7BE, United Kingdom

45. Algesiologikum MVZ München, Munich, 80799, Germany

46. Pain Management Associates, Lee's Summit, MO 64086, USA

47. Santa Chiara University Hospital, Pisa, 56126, Italy

48. West Virginia University Neurosurgery, Morgantown, WV 26506, USA

49. Pain Medicine of South Australia, Wayville, South Australia, 5034, Australia

50. University of Rochester, Rochester, NY 14642, USA

51. Pinnacle Pain & Spine, Scottsdale, AZ 85260, USA

52. EvergreenHealth Neurosurgery, Kirkland, WA 98034, USA

53. Charles E Schmidt College of Medicine, Florida Atlantic University, Boca Raton, FL 33431, USA

54. Kobe University Hospital, Kobe City, Hyōgo, 650-0017, Japan

55. Marqués de Valdecilla University Hospital, Santander, 39008, Spain

56. Medical University of South Carolina, Mount Pleasant, SC 29425, USA

57. Raleigh Neurology Associates, Raleigh NC 27607, USA

58. Odense University Hospital, Odense, 5000, Denmark

59. Sourasky Medical Center, Tel Aviv, 6423914, Israel

60. Sydney Spine & Pain, Hurstville, NSW, 2220, Australia

61. Sentara Neurosurgery Specialists, Virginia Beach, VA 23454, USA

62. Sahlgrenska University Hospital, Gothenburg, 413 46, Sweden

63. Comprehensive Spine & Sports Center, Campbell, CA 95008, USA

64. Metropolitan Pain Management Consultants, Sacramento, CA 95821, USA

65. University Hospital Donostia, San Sebastián, 20014, Spain

66. AMPM Research Clinic, Miami Gardens, FL 33169, USA

67. Indiana University Health, Muncie, IN 47303, USA

68. Conejo Pain Specialists Medical Group, Thousand Oaks, CA 91360, USA

69. Insight Neurosurgery, Dearborn Heights, MI 48091, USA

70. Mississippi Sports Medicine & Orthopaedic Center, Jackson, MS 39110, USA

71. University of Saskatchewan College of Medicine, Saskatoon, SK, S7N 5E5, Canada

72. AZ Delta, Roeselare, 8800, Belgium

73. Coastal Pain & Spinal Diagnostics, Carlsbad, CA 92009, USA

74. Pain Management Centers of America, Evansville, IN 47714, USA

75. Pain Medicine Associates, Newport Beach, CA 92663, USA

76. University of Florida Health, Gainesville, FL 32610, USA

77. Hyōgo College of Medicine Hospital, Nishinomiya, Hyōgo, 663-8501, Japan

78. The Raso Pain Center, Jupiter, FL 33477, USA

79. Precision Spine Care, Tyler, TX 75701, USA

80. International Hospital of Colombia, Bucaramanga - Piedecuesta, Santander, Columbia

81. Kindai University, Faculty of Medicine, Osaka-sayama, Osaka, 577-8502, Japan

82. Rijnstate Hospital, Arnhem, 6815, The Netherlands

83. Pain Matrix, Berwick, Victoria, 3806, Australia

84. Fundación CENIT, Buenos Aires, C1125 CABA, Argentina

85. University of Illinois, Chicago, IL 60607, USA

86. The Ohio State University Medical Center, Columbus, OH 43210, USA

87. Tokyo Metropolitan Neurological Hospital, Tokyo, 150-0013, Japan

88. Green Lizard Science, Claremont, Western Australia, 6010, Australia

89. Boston Scientific Neuromodulation, Valencia, CA 91355, USA

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. Clinical Trial Registration: NCT01719055 ( ClinicalTrials.gov )

Funder

Boston Scientific Corporation

Publisher

Future Medicine Ltd

Subject

General Medicine

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