title: Infectious complications related to intrathecal drug delivery system and spinal cord stimulator system implantations at a comprehensive cancer pain center.
abstract: BACKGROUND
  Intrathecal drug delivery (IDD) and spinal cord stimulator (SCS) systems are implantable devices for the management of both chronic and cancer pain. Although these therapies have favorable long-term outcomes, they are associated with occasional complications including infection. The incidence of infectious complications varies from 2 - 8% and frequently requires prolonged antibiotics and device revision or removal. Cancer patients are particularly susceptible to infectious complications because they are immunocompromised, malnourished, and receiving cytotoxic cancer-related therapies.
  
  
  OBJECTIVE
  Determine if cancer pain patients have a higher incidence of infectious complications following implantation of IDD or SCS systems than non-cancer pain patients.
  
  
  METHODS
  Retrospective chart review.
  
  
  METHODS
  Single tertiary comprehensive cancer hospital.
  
  
  METHODS
  Following local Institutional Review Board (IRB) approval, we collected data on infectious complications for IDD and SCS systems implanted at MD Anderson Cancer Center for the treatment of cancer and chronic pain. The examined implants were performed from July 15, 2006, to July 14, 2009. In addition, we obtained data regarding patient comorbidities and perioperative risk factors to assess their impact on infectious complications.
  
  
  RESULTS
  One hundred forty-two devices were implanted in 131 patients during the examined period. Eighty-three of the devices were IDD systems and 59 were SCS systems. Eighty percent of the patients had a diagnosis of cancer. Four infectious complications were noted with an overall infectious risk of 2.8%. The infection rate was 2.4% for IDD systems versus 3.4% for SCS systems (P = 1). All infections were at the implantable pulse generator (IPG) or pump pocket site. The rate of infection was 2.7% for cancer patients and 3.3% for non-cancer patients (P = 1). Neither the perioperative administration of prophylactic antibiotics (P = 0.4) nor the National Nosocomial Infection Surveillance (NNIS) risk level for individual patients (P = 0.15) were statistically associated with infectious complication. The mean surgical time was longer for cases with infection at 215 ± 93 minutes versus 132 ± 52 minutes for those without infection which was statistically significant (P = 0.02).
  
  
  CONCLUSIONS
  The major limitation of this study is that it was a retrospective analysis. An additional limitation is that 51(38.9%) of our patients either died or were lost to follow-up during the year following implantation which may have led to an underestimation of our infection rates.
  
  
  CONCLUSIONS
  The experience of this tertiary cancer pain center demonstrates that infectious complications following implantation of IDD and SCS systems are relatively rare events in cancer patients. Contrary to our initial hypothesis, no difference was found in the infection rate between cancer and non-cancer patients. The main factor associated with increased risk of infectious complications was increased surgical time, indicating a need to minimize patient time in the operating room. The low infectious complication rate seen in this series compared to previous reports in non-cancer patients is likely multifactorial in nature.
authors.affiliation: MD Anderson Cancer Center, Department of Pain Medicine 1515 Holcombe Blvd, Unit 409 Houston TX 77030-0409, USA. mpengle@mdanderson.org
authors.forename: Mitchell P
authors.initials: MP
authors.lastname: Engle
authors.forename: Baominh P
authors.initials: BP
authors.lastname: Vinh
authors.forename: Nusrat
authors.initials: N
authors.lastname: Harun
authors.forename: Dhanalakshmi
authors.initials: D
authors.lastname: Koyyalagunta
mesh_terms: D003428:Cross Infection / Q000209:etiology*; D016503:Drug Delivery Systems / Q000009:adverse effects*; D005260:Female; D006801:Humans; D007278:Injections, Spinal / Q000009:adverse effects*; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000150:complications; D010146:Pain / Q000209:etiology; D018710:Pain Clinics; D059408:Pain Management; D012189:Retrospective Studies; D062187:Spinal Cord Stimulation / Q000009:adverse effects*; D016896:Treatment Outcome