Infection Rates of Electrical Leads Used for Percutaneous Neurostimulation of the Peripheral Nervous System.
Percutaneous neurostimulation of the peripheral nervous system involves the insertion of a wire "lead" through an introducing needle to target a nerve/plexus or a motor point within a muscle. Electrical current may then be passed from an external generator through the skin via the lead for various therapeutic goals, including providing analgesia. With extended use of percutaneous leads sometimes greater than a month, infection is a concern. It was hypothesized that the infection rate of leads with a coiled design is lower than for leads with a noncoiled cylindrical design.



The literature was retrospectively reviewed for clinical studies of percutaneous neurostimulation of the peripheral nervous system of greater than 2 days that included explicit information on adverse events. The primary endpoint was the number of infections per 1,000 indwelling days.



Forty-three studies were identified that met inclusion criteria involving coiled (n = 21) and noncoiled (n = 25) leads (3 studies involved both). The risk of infection with noncoiled leads was estimated to be 25 times greater than with coiled leads (95% confidence interval [CI] 2 to 407, P = 0.006). The infection rates were estimated to be 0.03 (95% CI 0.01 to 0.13) infections per 1,000 indwelling days for coiled leads and 0.83 (95% CI 0.16 to 4.33) infections per 1,000 indwelling days for noncoiled leads (P = 0.006).



Percutaneous leads used for neurostimulation of the peripheral nervous system have a much lower risk of infection with a coiled design compared with noncoiled leads: approximately 1 infection for every 30,000 vs. 1,200 indwelling days, respectively.
Department of Anesthesiology, University of California San Diego, San Diego, CA, U.S.A.
Brian M
BM
Ilfeld
Department of Anesthesiology, University of California San Diego, San Diego, CA, U.S.A.
Rodney A
RA
Gabriel
MossRehab, Elkins Park, PA, U.S.A.|Department of Rehabilitation Medicine, Sidney Kimmel Medical College, Philadelphia, PA, U.S.A.
Michael F
MF
Saulino
Department of Physical Medicine and Rehabilitation, Case Western Reserve University, Cleveland, OH, U.S.A.|MetroHealth Rehabilitation Institute, MetroHealth System, Cleveland, OH, U.S.A.|Cleveland Functional Electrical Stimulation Center, Cleveland, OH, U.S.A.
John
J
Chae
Biomedical Engineering and Orthopaedics, Case Western Reserve University, Cleveland, OH, U.S.A.
P Hunter
PH
Peckham
Department of Anesthesiology, Duke University Medical Center, Durham, NC, U.S.A.
Stuart A
SA
Grant
Department of Anesthesiology, Wake Forest University Baptist Medical Center, Winston-Salem, NC, U.S.A.|The Center for Clinical Research, Winston-Salem, NC, U.S.A.|Carolinas Pain Institute, Winston-Salem, NC, U.S.A.
Christopher A
CA
Gilmore
Department of Neurology, Keck School of Medicine, University of Southern California, Los Angeles, CA, U.S.A.
Michael C
MC
Donohue
SPR Therapeutics, LLC, Chapel Hill, NC, U.S.A.
Matthew G
MG
deBock
SPR Therapeutics, LLC, Chapel Hill, NC, U.S.A.
Amorn
A
Wongsarnpigoon
SPR Therapeutics, LLC, Chapel Hill, NC, U.S.A.
Joseph W
JW
Boggs
D000698:Analgesia / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods; D004599:Electric Stimulation Therapy / Q000009:adverse effects* / Q000295:instrumentation / Q000379:methods; D004866:Equipment Contamination; D006801:Humans; D009339:Needles / Q000009:adverse effects* / Q000382:microbiology*; D059408:Pain Management / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods; D017933:Peripheral Nervous System / Q000382:microbiology* / Q000503:physiopathology; D012189:Retrospective Studies
helical lead; neuromodulation; percutaneous peripheral nerve stimulation; peripheral nerve stimulator; postoperative pain; small-diameter open-coiled helical lead
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