Background Chronic back pain is a prevalent disease and has a high impact in daily life.
Implantable devices (IDs) for chronic pain management include spinal cord stimulation (SCS)
systems and intrathecal drug delivery (ITDD) pumps. The number of ITDD implants have increased
exponentially in the last decade. The number of complications, such as infections, are also more
prevalent. Infection management guidelines are needed to standarize our clinical practice and
define protocols of explantation.
Objectives: The primary outcome is to define the likelihood of device explantation regarding
some covariates related to the patient, antibiotic therapy or surgerical procedures. The secondary
outcome is to evaluate performance compared to the results published in the literature.
Study Design: Retrospective study.
Setting: Hospital General of Valencia. Valencia. Spain.
Methods: A retrospective study of 288 implantable device surgeries was conducted at the Hospital
General Universitary of Valencia (Spain) from 1994 to 2015. Demographical and infection data
were collected. We have followed the “guidelines for the diagnosis, prevention and management
of implantable electronic cardiac device infection” due to the lack of a specific guideline in our
field.
Results: Forty-three out of 288 procedures were identified as suspected device-infected
interventions. Half of the patients had microbiologically confirmed infection after wound, blood or
lumbar fluid culture. The odds ratio (OR) for explantation of the device was 19 for the presence of
decubitus, a sign of medical device related pressure injury (P < 0.0005) and 5 for positive wound
culture (P < 0.0452). Medical indication leading to device implantation and the antibiotics on
discharge also played a role in the decision of device explantation.
Limitations: Lack of external validity and others.
Conclusion: In this study, presence of decubitus is the defining variable for device explantation
when a infection is suspected rather than waiting to culture results. Due to a high variability in
infection rates, multidisciplinary guidelines are needed to provide an approach that focuses on
accurate data monitoring, rigurous implantation technique and standardized protocols.
Key Words: Chronic pain, spinal cord stimulation infection, neurostimulator, intrathecal drug
delivery pump, complication, infection, explantation
Medical Device Related Pressure Injury in the
Treatment of Chronic Pain: An Early Sign of
Explantation in Suspected Infection
