Medical Device Related Pressure Injury in the Treatment of Chronic Pain: An Early Sign of Explantation in Suspected Infection.

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.