Infections Associated with Medtronic Duet External Ventricular Drains - Rhode Island Hospital, Providence, Rhode Island, January 2023-January 2024.

External ventricular drains (EVDs) are medical devices that are inserted into the ventricles of the brain to drain excess fluid, manage intracranial hypertension, monitor intracranial pressure, and administer medications. Unintentional disconnections and breaks or fractures (breaks) of EVDs or associated drainage system components can result in cerebrospinal fluid (CSF) leakage and increased risk for EVD-associated infections. After replacement of Integra Life Sciences EVD systems with Medtronic Duet EVD systems at Rhode Island Hospital in mid-September 2023, a threefold increase was observed in the prevalence of positive CSF cultures, from 2.8 per 1,000 days with an EVD in place (EVD days) during January-September 2023 to 11.4 per 1,000 EVD days during October 2023-January 2024 (rate ratio [RR] = 5.7; 95% CI = 1.5-22.0; p = 0.01) and an eightfold increase in the prevalence of infections, from 0.7 to 6.5 per 1,000 EVD days (RR = 9.8; 95% CI = 1.1-87.3; p = 0.04). An investigation by Rhode Island Hospital Infection Control during December 2023-January 2024 identified frequent reports of disconnections and breaks of the Medtronic Duet EVD system. A search of the Food and Drug Administration Manufacturer and User Facility Device Experience database identified 326 reports nationwide of disconnection and breaks of components of the Duet EVD system, including 175 during 2023. A Medical Product Safety Network report was filed. The Duet EVD product was ultimately recalled in January 2024, citing disconnections of the EVD system and reports of CSF leakage and infection. Given the widespread use of EVD systems by neurosurgery centers and the risk for EVD-associated infections, a strategy for future consideration by hospital infection prevention and control programs might be inclusion of EVD-associated infections in hospital surveillance programs to rapidly identify increases in these events and determine factors related to such infections to prevent additional infections.

Differences in microorganisms causing infection after cranial and spinal surgeries.

OBJECTIVE: The primary aim of this retrospective study was to assess differences in the pathogens causing surgical site infections (SSIs) following craniectomies/craniotomies and open spinal surgery. The secondary aim was to assess differences in rates of SSI among these operative procedures. METHODS: ANOVA tests with Bonferroni correction and incidence risk ratios (RRs) were used to identify differences in pathogens by surgical site and procedure using retrospective, de-identified records of 19,993 postneurosurgical patients treated between 2007 and 2020. RESULTS: The overall infection rates for craniotomy/craniectomy, laminectomy, and fusion were 2.1%, 1.1%, and 1.5%, respectively, and overall infection rates for cervical, thoracic, and lumbar spine surgery were 0.3%, 1.6%, and 1.9%, respectively. Craniotomy/craniectomy was more likely to result in an SSI than spine surgery (RR 1.8, 95% CI 1.4-2.2, p < 0.0001). Cutibacterium acnes (RR 24.2, 95% CI 7.3-80.0, p < 0.0001); coagulase-negative staphylococci (CoNS) (methicillin-susceptible CoNS: RR 2.9, 95% CI 1.6-5.4, p = 0.0006; methicillin-resistant CoNS: RR 5.6, 95% CI 1.4-22.3, p = 0.02); Klebsiella aerogenes (RR 6.5, 95% CI 1.7-25.1, p = 0.0003); Serratia marcescens (RR 2.4, 95% CI 1.1-7.1, p = 0.01); Enterobacter cloacae (RR 3.1, 95% CI 1.2-8.1, p = 0.02); and Candida albicans (RR 3.9, 95% CI 1.2-12.3, p = 0.02) were more commonly associated with craniotomy/craniectomy cases than fusion or laminectomy SSIs. Pseudomonas aeruginosa was more commonly associated with fusion SSIs than craniotomy SSIs (RR 4.4, 95% CI 1.3-14.8, p = 0.02), whereas Escherichia coli was nonsignificantly associated with fusion SSIs compared to craniotomy SSIs (RR 4.1, 95% CI 0.9-18.1, p = 0.06). Infections with E. coli and P. aeruginosa occurred primarily in the lumbar spine (p = 0.0003 and p = 0.0001, respectively). CONCLUSIONS: SSIs due to typical gastrointestinal or genitourinary gram-negative bacteria occur most commonly following lumbar surgery, particularly fusion, and are likely to be due to contamination of the surgical bed with microbial flora in the perianal area and genitourinary tract. Cutibacterium acnes in the skin flora of the head and neck increases risk of infection due to this microbe following surgical interventions in these body sites. The types of gram-negative bacteria associated with craniotomy/craniectomy SSIs suggest potential environmental sources of these pathogens. Based on the authors' findings, neurosurgeons should consider using a two-step skin preparation with benzoyl peroxide, in addition to a standard antiseptic such as alcoholic chlorhexidine for cranial, cervical, and upper thoracic surgeries. Additionally, broader gram-negative bacterial coverage, such as use of a third-generation cephalosporin, should be considered for lumbar/lumbosacral fusion surgical antibiotic prophylaxis.

Venous Access: National Guideline and Registry Development (VANGUARD): Advancing Patient-Centered Venous Access Care Through the Development of a National Coordinated Registry Network.

There are over 8 million central venous access devices inserted each year, many in patients with chronic conditions who rely on central access for life-preserving therapies. Central venous access device-related complications can be life-threatening and add tens of billions of dollars to health care costs, while their incidence is most likely grossly mis- or underreported by medical institutions. In this communication, we review the challenges that impair retention, exchange, and analysis of data necessary for a meaningful understanding of critical events and outcomes in this clinical domain. The difficulty is not only with data extraction and harmonization from electronic health records, national surveillance systems, or other health information repositories where data might be stored. The problem is that reliable and appropriate data are not recorded, or falsely recorded, at least in part because policy, payment, penalties, proprietary concerns, and workflow burdens discourage completeness and accuracy. We provide a roadmap for the development of health care information systems and infrastructure that address these challenges, framed within the context of research studies that build a framework of standardized terminology, decision support, data capture, and information exchange necessary for the task. This roadmap is embedded in a broader Coordinated Registry Network Learning Community, and facilitated by the Medical Device Epidemiology Network, a Public-Private Partnership sponsored by the US Food and Drug Administration, with the scope of advancing methods, national and international infrastructure, and partnerships needed for the evaluation of medical devices throughout their total life cycle.

Introduction to A Compendium of Strategies to Prevent Healthcare-Associated Infections In Acute-Care Hospitals: 2022 Updates.

Since the initial publication of A Compendium of Strategies to Prevent Healthcare-Associated Infections in Acute Care Hospitals in 2008, the prevention of healthcare-associated infections (HAIs) has continued to be a national priority. Progress in healthcare epidemiology, infection prevention, antimicrobial stewardship, and implementation science research has led to improvements in our understanding of effective strategies for HAI prevention. Despite these advances, HAIs continue to affect ∼1 of every 31 hospitalized patients, leading to substantial morbidity, mortality, and excess healthcare expenditures, and persistent gaps remain between what is recommended and what is practiced.The widespread impact of the coronavirus disease 2019 (COVID-19) pandemic on HAI outcomes in acute-care hospitals has further highlighted the essential role of infection prevention programs and the critical importance of prioritizing efforts that can be sustained even in the face of resource requirements from COVID-19 and future infectious diseases crises.The Compendium: 2022 Updates document provides acute-care hospitals with up-to-date, practical expert guidance to assist in prioritizing and implementing HAI prevention efforts. It is the product of a highly collaborative effort led by the Society for Healthcare Epidemiology of America (SHEA), the Infectious Disease Society of America (IDSA), the Association for Professionals in Infection Control and Epidemiology (APIC), the American Hospital Association (AHA), and The Joint Commission, with major contributions from representatives of organizations and societies with content expertise, including the Centers for Disease Control and Prevention (CDC), the Pediatric Infectious Disease Society (PIDS), the Society for Critical Care Medicine (SCCM), the Society for Hospital Medicine (SHM), the Surgical Infection Society (SIS), and others.

Alpha Defensin-1 Biomarker Outperforms Culture in Diagnosing Breast Implant-Related Infection: Results from a Multicenter Prospective Study.

BACKGROUND: Prompt diagnosis of breast implant infection is critical to reducing morbidity. A high incidence of false-negative microbial culture mandates superior testing modalities. Alpha defensin-1 (AD-1), an infection biomarker, has outperformed culture in diagnosing periprosthetic joint infection with sensitivity/specificity of 97%. After previously demonstrating its feasibility in breast implant-related infection (BIRI), this case-control study compares the accuracy of AD-1 to microbial culture in suspected BIRI. METHODS: An institutional review board-approved, prospective, multicenter study was conducted of adults with prior breast implant reconstruction undergoing surgery for suspected infection (cases) or prosthetic exchange/revision (controls). Demographics, perioperative characteristics, antibiotic exposure, and implant pocket fluid were collected. Fluid samples underwent microbial culture, AD-1 assay, and adjunctive markers (C-reactive protein, lactate, cell differential); diagnostic performance was assessed by means of sensitivity, specificity, and accuracy from receiver operating characteristic curve analysis, with values of P < 0.05 considered significant. RESULTS: Fifty-three implant pocket samples were included (cases, n = 20; controls, n = 33). All 20 patients with suspected BIRI exhibited cellulitis, 65% had abnormal drainage, and 55% were febrile. All suspected BIRIs were AD-1 positive (sensitivity, 100%). Microbial culture failed to grow any microorganisms in four BIRIs (sensitivity, 80%; P = 0.046); Gram stain was least accurate (sensitivity, 25%; P < 0.001). All tests demonstrated 100% specificity. Receiver operating characteristic curve analyses yielded the following areas under the curve: AD-1, 1.0; microbial culture, 0.90 ( P = 0.029); and Gram stain, 0.62 ( P < 0.001). Adjunctive markers were significantly higher among infections versus controls ( P < 0.001). CONCLUSIONS: Study findings confirm the accuracy of AD-1 in diagnosing BIRI and indicate superiority to microbial culture. Although further study is warranted, AD-1 may facilitate perioperative decision-making in BIRI management in a resource-efficient manner. CLINICAL QUESTION/LEVEL OF EVIDENCE: Diagnostic, II.

Development and validation of a multivariable model predicting the required catheter dwell time among mechanically ventilated critically ill patients in three randomized trials.

BACKGROUND: The anatomic site for central venous catheter insertion influences the risk of central venous catheter-related intravascular complications. We developed and validated a predictive score of required catheter dwell time to identify critically ill patients at higher risk of intravascular complications. METHODS: We retrospectively conducted a cohort study from three multicenter randomized controlled trials enrolling consecutive patients requiring central venous catheterization. The primary outcome was the required catheter dwell time, defined as the period between the first catheter insertion and removal of the last catheter for absence of utility. Predictors were identified in the training cohort (3SITES trial; 2336 patients) through multivariable analyses based on the subdistribution hazard function accounting for death as a competing event. Internal validation was performed in the training cohort by 500 bootstraps to derive the CVC-IN score from robust risk factors. External validation of the CVC-IN score were performed in the testing cohort (CLEAN, and DRESSING2; 2371 patients). RESULTS: The analysis was restricted to patients requiring mechanical ventilation to comply with model assumptions. Immunosuppression (2 points), high creatinine > 100 micromol/L (2 points), use of vasopressor (1 point), obesity (1 point) and older age (40-59, 1 point; ≥ 60, 2 points) were independently associated with the required catheter dwell time. At day 28, area under the ROC curve for the CVC-IN score was 0.69, 95% confidence interval (CI) [0.66-0.72] in the training cohort and 0.64, 95% CI [0.61-0.66] in the testing cohort. Patients with a CVC-IN score ≥ 4 in the overall cohort had a median required catheter dwell time of 24 days (versus 11 days for CVC-IN score < 4 points). The positive predictive value of a CVC-IN score ≥ 4 was 76.9% for > 7 days required catheter dwell time in the testing cohort. CONCLUSION: The CVC-IN score, which can be used for the first catheter, had a modest ability to discriminate required catheter dwell time. Nevertheless, preference of the subclavian site may contribute to limit the risk of intravascular complications, in particular among ventilated patients with high CVC-IN score. Trials Registration NCT01479153, NCT01629550, NCT01189682.

Reducing ventriculoperitoneal shunt infection with intraoperative glove removal.

BACKGROUND: Contamination of ventriculoperitoneal shunts (VPS) by cutaneous flora, particularly coagulase-negative staphylococci, is a common cause of shunt infection and failure, leading to prolonged hospital stay, higher costs of care, and poor outcomes. Glove contamination may occur during VPS insertion, increasing risk of such infections. METHODS: We performed a systematic search of the PubMed database for studies published January 1, 1970, through August 31, 2021 that documented VPS infection rates before and after implementing a practice of double gloving with change or removal of the outer glove immediately prior to shunt insertion. RESULTS: Among 272 reports screened, 4 were eligible for review based on our inclusion criteria. The incidence of VPS infection was reduced in all 4 quasi-experimental studies with an aggregate incidence of VPS infection of 11.8% before the change in intraoperative protocol and 4.9% after protocol change. One study documented reduced hospital stay with this change in protocol. CONCLUSION: The risk of VPS infection is reduced by removal or replacement of the outer surgical gloves immediately prior to intraoperative insertion of a VPS as part of an infection control bundle.

Seasonality of healthcare-associated Stenotrophomonas maltophilia.

From April 1, 2016, through March 31, 2022, growth of Stenotrophomonas maltophilia from clinical specimens at our academic medical center was significantly more likely during July-September than during other calendar quarters.

Antibiotic prophylaxis in penetrating traumatic brain injury: analysis of a single-center series and systematic review of the literature.

PURPOSE: Penetrating traumatic brain injury (pTBI) is an acute medical emergency with a high rate of mortality. Patients with survivable injuries face a risk of infection stemming from foreign body transgression into the central nervous system (CNS). There is controversy regarding the utility of antimicrobial prophylaxis in managing such patients, and if so, which antimicrobial agent(s) to use. METHODS: We reviewed patients with pTBI at our institution and performed a PRISMA systematic review to assess the impact of prophylactic antibiotics on reducing risk of CNS infection. RESULTS: We identified 21 local patients and 327 cases in the literature. In our local series, 17 local patients received prophylactic antibiotics; four did not. Overall, five of these patients (24%) developed a CNS infection (four and one case of intraparenchymal brain abscess and meningitis, respectively). All four patients who did not receive prophylactic antibiotics developed an infection (three with CNS infections; one superficial wound infection) compared to two of 17 (12%) patients who did receive prophylactic antibiotics. Of the 327 pTBI cases reported in the literature, 216 (66%) received prophylactic antibiotics. Thirty-eight (17%) patients who received antibiotics developed a CNS infection compared to 21 (19%) who did not receive antibiotics (p = 0.76). CONCLUSIONS: Although our review of the literature did not reveal any benefit, our institutional series suggested that patients with pTBI may benefit from prophylactic antibiotics. We propose a short antibiotic course with a regimen specific to cases with and without the presence of organic debris.

Development and validation of a multivariable prediction model of central venous catheter-tip colonization in a cohort of five randomized trials.

BACKGROUND: The majority of central venous catheters (CVC) removed in the ICU are not colonized, including when a catheter-related infection (CRI) is suspected. We developed and validated a predictive score to reduce unnecessary CVC removal. METHODS: We conducted a retrospective cohort study from five multicenter randomized controlled trials with systematic catheter-tip culture of consecutive CVCs. Colonization was defined as growth of ≥103 colony-forming units per mL. Risk factors for colonization were identified in the training cohort (CATHEDIA and 3SITES trials; 3899 CVCs of which 575 (15%) were colonized) through multivariable analyses. After internal validation in 500 bootstrapped samples, the CVC-OUT score was computed by attaching points to the robust (> 50% of the bootstraps) risk factors. External validation was performed in the testing cohort (CLEAN, DRESSING2 and ELVIS trials; 6848 CVCs, of which 588 (9%) were colonized). RESULTS: In the training cohort, obesity (1 point), diabetes (1 point), type of CVC (dialysis catheter, 1 point), anatomical insertion site (jugular, 4 points; femoral 5 points), rank of the catheter (second or subsequent, 1 point) and catheterization duration (≥ 5 days, 2 points) were significantly and independently associated with colonization . Area under the ROC curve (AUC) for the CVC-OUT score was 0.69, 95% confidence interval (CI) [0.67-0.72]. In the testing cohort, AUC for the CVC-OUT score was 0.60, 95% CI [0.58-0.62]. Among 1,469 CVCs removed for suspected CRI in the overall population, 1200 (82%) were not colonized. The negative predictive value (NPV) of a CVC-OUT score < 6 points was 94%, 95% CI [93%-95%]. CONCLUSION: The CVC-OUT score had a moderate ability to discriminate catheter-tip colonization, but the high NPV may contribute to reduce unnecessary CVCs removal. Preference of the subclavian site is the strongest and only modifiable risk factor that reduces the likelihood of catheter-tip colonization and consequently the risk of CRI. CLINICAL TRIALS REGISTRATION: NCT00277888, NCT01479153, NCT01629550, NCT01189682, NCT00875069.

Midline Catheters: Could They Replace a Central Vascular Access Device?

In the past 30 years, midline catheter use has grown rapidly. For several reasons, many providers and facilities are attempting to reduce the number of central venous catheters and subsequent central line-associated bloodstream infections (CLABSIs) by using midline catheters. Vessel preservation requires attention to all vascular access device (VAD)-associated complications and not only central line bloodstream infection. There is still much confusion about the appropriate tip location and the characteristics of fluids and medications that can safely be infused through a midline catheter residing in a peripheral vein. The Infusion Therapy Standards of Practice (the Standards) focuses on assessment of characteristics of infusion therapies that must be considered for VAD selection as an evidence-based list of fluids and medications for infusion through peripheral veins has yet to be established. This review of midline catheter studies evaluates the evidence regarding the substitution of a midline catheter for a central venous catheter. Many issues need to be addressed, such as studies that include an outcome list that mixes defined clinical complications (eg, thrombosis) with signs and symptoms of complications (eg, leaking). Another issue is basing a major change of clinical practice on retrospective chart reviews. Although a midline catheter may be appropriate for some patients, additional studies of a higher level of evidence are needed before this major practice change should occur.

Risk factors for early PICC removal: A retrospective study of adult inpatients at an academic medical center.

BACKGROUND: Use of PICCs has been rising since 2001. They are used when long-term intravenous access is needed and for blood draws in patients with difficult venous access. OBJECTIVE: To determine which risk factors contribute to inappropriate PICC line insertion defined as removal of a PICC within five days of insertion for reasons other than a PICC complication. DESIGN: Retrospective, observational study. SETTING: Tertiary-care, Level 1 trauma center. PATIENTS: Adult patients with a PICC removed 1/1/2017 to 5/4/2020. MEASUREMENTS: Frequency of PICC removal within five days of insertion and associated risk factors for early removal. RESULTS: Between 1/1/2017 and 5/4/2020, 995 of 5348 PICCs inserted by the IV nursing team were removed within five days (19%). In 2017, 5 of 429 PICCs developed a central line-associated infection (1.2%) and 29 of 429 PICCs developed symptomatic venous thromboembolism (6.7%). Patients with PICCs whose primary service was in an ICU were independently at higher risk of early removal (OR 1.44, 95% CI 1.14, 1.83); weekday insertion was independently associated with a lower likelihood of early removal compared to weekend insertion (OR 0.60; 95% CI 0.49, 0.75). LIMITATION: PICC removal after discharge was not assessed and paper records were likely incomplete and biased. CONCLUSION: Nearly one in five PICCs were removed within five days. Patients whose primary team was in an ICU and PICCs ordered on weekends were at independently higher risk of early removal.

The association between household and neighborhood characteristics and COVID-19 related ICU admissions.

Introduction: Approaches to COVID-19 mitigation can be more efficiently delivered with a more detailed understanding of where the severe cases occur. Our objective was to assess which demographic, housing and neighborhood characteristics were independently and collectively associated with differing rates of severe COVID-19. Methods: A cohort of patients with SARS-CoV-2 in a single health system from March 1, 2020 to February 15, 2021 was reviewed to determine whether demographic, housing, or neighborhood characteristics are associated with higher rates of severe COVID-19 infections and to create a novel scoring index. Characteristics included proportion of multifamily homes, essential workers, and ages of the homes within neighborhoods. Results: There were 735 COVID-19 ICU admissions in the study interval which accounted for 61 percent of the state's ICU admissions for COVID-19. Compared to the general population of the state those admitted to the ICU with COVID-19 were disproportionately older, male sex, and were more often Black, Indigenous, People of Color. Patients disproportionately resided in neighborhoods with three plus unit multifamily homes, homes built before 1940, homes with more than one person to a room, homes of lower average value, and in neighborhoods with a greater proportion of essential workers. From this our COVID-19 Neighborhood Index value was comparatively higher for the ICU patients (61.1) relative to the population of Rhode Island (49.4). Conclusion: COVID-19-related ICU admissions are highly related to demographic, housing and neighborhood-level factors. This may guide more nuanced and targeted vaccine distribution plans and public health measures for future pandemics.

Risk factors and outcomes associated with external ventricular drain infections.

BACKGROUND: Insertion of an external ventricular drain (EVD) is a common neurosurgical procedure which may lead to serious complications including infection. Some risk factors associated with EVD infection are well established. Others remain less certain, including specific indications for placement, prior neurosurgery, and prior EVD placement. OBJECTIVE: To identify risk factors for EVD infections. METHODS: We reviewed all EVD insertions at our institution from March 2015 through May 2019 following implementation of a standardized infection control protocol for EVD insertion and maintenance. Cox regression was used to identify risk factors for EVD infections. RESULTS: 479 EVDs placed in 409 patients met inclusion criteria, and 9 culture-positive infections were observed during the study period. The risk of infection within 30 days of EVD placement was 2.2% (2.3 infections/1,000 EVD days). Coagulase-negative staphylococci were identified in 6 of the 9 EVD infections). EVD infection led to prolonged length of stay post-EVD-placement (23 days vs 16 days; P = .045). Cox regression demonstrated increased infection risk in patients with prior brain surgery associated with cerebrospinal fluid (CSF) diversion (HR, 8.08; 95% CI, 1.7-39.4; P = .010), CSF leak around the catheter (HR, 21.0; 95% CI, 7.0-145.1; P = .0007), and insertion site dehiscence (HR, 7.53; 95% CI, 1.04-37.1; P = .0407). Duration of EVD use >7 days was not associated with infection risk (HR, 0.62; 95% CI, 0.07-5.45; P = .669). CONCLUSION: Risk factors associated with EVD infection include prior brain surgery, CSF leak, and insertion site dehiscence. We found no significant association between infection risk and duration of EVD placement.