A Standardized Protocol to Reduce Pediatric Baclofen Pump Infections: A Quality Improvement Initiative Kathryn M. Wagner, Virendra R. Desai, Jeffrey S. Raskin, Arvind Mohan, JoWinsyl Montojo, Valentina Briceno, Daniel J. Curry, Sandi Lam Division of Pediatric Neurosurgery, Texas Children s Hospital, Department of Neurosurgery, Baylor College of Medicine, Houston, Texas USA
Conflicts of interest No financial disclosures xxx00.#####.ppt 7/18/2017 8:09:21 AM
Introduction Intrathecal baclofen pump (IBP) indications include spasticity and dystonia. Foreign body implants in this pediatric population with comorbidities is reported to have a high risk of complications IBP complications are multiplicitous Pump malfunction Catheter fracture Migration Obstruction Wound breakdown Wound infection Exposed hardware Meningitis xxx00.#####.ppt 7/18/2017 8:09:22 AM
Introduction Infectious complications range from 3%-40% Reported risk factors include low body mass index (BMI), presence of gastrostomy, scoliosis, and other comorbidities A majority of infections occur within 60 days of surgery 4.0% in the first 60 days, 1.0% per year thereafter xxx00.#####.ppt 7/18/2017 8:09:22 AM
Introduction Patient risk factors BMI < 18 Those with spasticity and dystonia tend to have high metabolic needs suboptimal nutritional status Gastrostomy Tracheostomy xxx00.#####.ppt 7/18/2017 8:09:22 AM
Introduction Infections may be superficial or deep require explant of all hardware treatment with antibiotics management of symptoms with oral baclofen Various techniques have been suggested to minimize infection smaller pump size subfascial pump placement pre-operative chlorhexidine skin bath prophylactic antibiotics wound irrigation iodine-impregnated drapes and skin coverings double glove/glove change protocols complex closures xxx00.#####.ppt 7/18/2017 8:09:22 AM
Introduction On internal review, Texas Children s Hospital (TCH) had a 23% infection rate following baclofen pump surgery, higher than the national average Quality initiative for decreased infection at TCH This included development and implementation of an infection prevention bundle with perioperative checklist xxx00.#####.ppt 7/18/2017 8:09:22 AM
Methods An infection prevention bundle was created and implemented based on literature review and consensus opinion of pediatric neurosurgeons in the group when evidence was lacking Included checklists for diagnosis, pump type, and perioperative procedures Compliance rates prior to and following implementation were followed Pre- and post-implementation cases were retrospectively reviewed with minimum 3 month follow-up. xxx00.#####.ppt 7/18/2017 8:09:22 AM
Methods Intervention used a Plan-Do-Study-Act (PDSA) model, using shunt infection protocols from the Hydrocephalus Clinical Research Network as an example Primary outcome was infection rate before and after use of prevention bundle Secondary outcome was all complications of baclofen pump surgery xxx00.#####.ppt 7/18/2017 8:09:23 AM
Figure 1: Infection prevention bundle which includes pre-operative, intra-operative and post-operative steps. xxx00.#####.ppt 7/18/2017 8:09:23 AM
Figure 1: Infection prevention bundle which includes pre-operative, intra-operative and post-operative steps. xxx00.#####.ppt 7/18/2017 8:09:23 AM
Methods Clavien-Dindo classification used to categorize complications Grade II or higher included in analysis xxx00.#####.ppt 7/18/2017 8:09:23 AM
Methods Total complications included return to OR for any reason pump malfunction tube fracture Infection wound infection wound dehiscence cerebrospinal fluid (CSF) leaks Medical complications such as UTI or pneumonia were not included in analysis xxx00.#####.ppt 7/18/2017 8:09:23 AM
Methods Practice followed guidelines from the Intrathecal Baclofen Therapy Best Practice Forum: All cases with suspected infection have local pump site and CSF tested for infection. If both are infected, the pump is explanted; if the local pumpsite is infected but the CSF is negative, a three-day course of intravenous antibiotics is given with repeat testing of local pump site and removal of pump if the repeat testing is positive. xxx00.#####.ppt 7/18/2017 8:09:24 AM
Results Total baclofen pump surgeries (128) Pre-protocol (n=64) Post-protocol (n=64) There were a total of 128 baclofen pump surgeries, 64 pre-protocol and 64 post-protocol; age range was 3-27 years old. There was an 82% overall compliance rate to the infection prevention bundle. xxx00.#####.ppt 7/18/2017 8:09:24 AM
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Results Prior to protocol implementation, most complications were grade II or III-b After protocol implementation, complications significantly decreased, and included I, II and III-b xxx00.#####.ppt 7/18/2017 8:09:24 AM
Table 2: Complications before and after baclofen protocol initiation Complication category CD-grade Details Before Protocol CSF leak and Infection III-b pump explantation, CSF leak repair Pump Malfunction III-b exploration/catheter replacement Pump malfunction III-b Infection III-b wound washout, pump explantation Dehiscence and Infection III-b Infection III-b wound washout, pump revision, then explantation Infection III-b Drainage from incision II intravenous antibiotics Drainage from incision per parents, only II intravenous antibiotics fibrinous tissue seen in house Chemical meningitis and possible occult CSF leak II medical therapy for chemical meningitis Dehiscence III-b wound washout, pump revision Dehiscence and CSF leak III-b wound washout Dehiscence III-b wound washout, pump revision Replacement of dislodged catheter III-b catheter revision, then pump explantation Intrathecal hemorrhage III-b staged laminectomy with delayed catheter placement
Table 2: Complications before and after baclofen protocol initiation Complication CD-grade Details category After protocol Other I abdominal fluid tap (culture negative) Infection III-b wound revision Infection II oral antibiotics Other I local wound care Other III-b reexploration and repositioning of catheter Infection II oral antibiotics Other I local wound care CSF leak/infection III-b wound revision Other III-b exploration and repositioning of catheter
Results Infection rates pre- and post-implementation were 12.5% and 6.3%, respectively (p=0.225). Absolute risk reduction of 6.3% (-3.8% - 16.3%) Relative risk reduction of 50% Total complication rates pre- and post-implementation were 23.4% and 9.4%, respectively (p=0.032). Absolute risk reduction of 14.1% (1.5% - 26.7%) Relative risk reduction of 60% xxx00.#####.ppt 7/18/2017 8:09:27 AM
Table 3: Pre and Post protocol implementation Before After AR [95% CI] RR [95% CI] (p) Infection (%) 12.5 6.3 6.3 [-3.8; - 16.3] 50 0.225 Complications (%) 23.4 9.4 14.1 [1.5; 26.7] 60 0.032 * AR, absolute risk reduction; RR, relative risk reduction; CI, confidence interval
Discussion By developing and implementing an evidence-driven protocol at our institution, we significantly decreased perioperative complication rates associated with baclofen pumps Limitations of the study include the single-institution setting and small sample size. The combined infection prevention bundle complicates the identification of interventions which prevented complication versus that which had no effect.
Discussion Larger, multicenter studies are needed to further characterize effects of standardized interventions like checklists to prevent infection Our protocol showed the feasibility of involving many peri-operative services in quality improvement, with 82% compliance
Conclusions A workflow paradigm unique to baclofen pump implantation aimed at decreasing implant-related infections was implemented. Total complication rate following intrathecal baclofen pump surgery was significantly lower after quality improvement protocol implementation. This study is a successful example of checklist standardization to diminish special cause variability.
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