Implementation of an adapted perioperative ventriculoperitoneal shunting protocol in a tertiary center located in a low-to-middle-income country

doi:10.21203/rs.3.rs-3987935/v1

Objective

Preventative protocols have efficaciously reduced shunt infection in developed countries. However, the generalizability of these protocols in low-to-middle-income countries (LMICs) remains unclear. Previously, shunt insertion in the authors’ center were routinely performed under institutional preventative precautions, which was updated via merging with Hydrocephalus Clinical Research Network (HCRN) protocol. This study aimed to investigate the ventriculoperitoneal shunt (VPS) infection rates in pediatric patients following the implementation of the adapted protocol.

Methods

The adapted protocol was implemented in all first-time VPS implantations between 2011–2021. The primary outcome was six-month shunt infection. The Pearson Chi-square test was used for categorical variables and the Mann-Whitney U-test for numeric variables to evaluate the correlation with shunt infection.

Results

352 first-time VPS procedures were performed adhering to the adapted protocol. The median age was 5 months, and 189 (53.7%) were male. Overall, 37 patients (10.5%) experienced shunt infection, with 30 (8.5%) occurring within the first six months, which were lower than 13.3% infection rate of the previous series of the same center. The infection rate was slightly higher than the 5.7% and 6.0% rates reported by HCRN studies. Patients with shunt infection were significantly younger (7.5 versus 17.5 months, P < 0.001).

Conclusions

This study validates the efficacy of an adapted perioperative protocol in mitigating shunt infection in a high-volume center in a LMIC. Adhering to a step-by-step protocol, modified to suit the healthcare resources and financial constraints of LMICs, could maintain low shunt infection rates that are roughly comparable to those of centers in high-income countries.

Cerebrospinal fluid

Hydrocephalus

Ventriculoperitoneal shunt

Shunt infection

Clinical protocols

Cerebrospinal fluid (CSF) shunt infection is a common complication that can occur following shunt implantation. With an estimated incidence rate of 11% [34, 39], it can result in a mortality rate of 10–15%, as well as long-term morbidities [13, 41]. Treating shunt infections is a costly endeavor [33], requiring prolonged hospitalization, intravenous antibiotic therapy, removal or externalization of the infected shunt, and new shunt insertion [15, 39]. Despite receiving standard medical and surgical care, shunt reinfection remains a common occurrence [35, 36].

Currently, shunt protocols are designed for preserving resources in high-income countries[16, 17, 29, 44]. Applying these protocols would be challenging for low- to middle-income countries (LMICs) due to the anticipated high cost of compliance with well-established protocols[37]. Considering the differences in the conditions and resources of LMICs, developing a standardized protocol tailored to each country seems essential.

Prior to the implementation of the original Hydrocephalus Clinical Research Network (HCRN) protocol in 2011, shunt insertion in the authors’ center was done under institutional literature-based protective strategies[20]. Following the success of the HCRN protocol in reducing shunt infections[17], an updated modified protocol was implemented in the authors' institution, merging the former institutional items and the published HCRN protocol. Although HCRN group further published simplified protocols in 2016 and 2022 [5, 16], we have still adhered to our original adapted protocol to overcome the limitations that pediatric neurosurgeons encountered in LMICs. This study aims to evaluate the infection rates following the first-time ventriculoperitoneal shunt (VPS) insertion using the modified protocol for a LMIC.

Study settings

The study was conducted in a high-volume tertiary pediatric hospital, with an annually rate of 60–70 shunt insertion added to an approximately the same rate of shunt revision. The study was retrospectively designed to assess the rate of shunt infection in patients who underwent their first VPS insertion under the institutional modified perioperative protocol.

Eligibility Criteria

Pediatric patients (< 12 years) with documented hydrocephalus, undergone VPS insertion for the first time under the proposed institutional protocol, were enrolled. Exclusion criteria included: (1) Shunt revision, (2) shunt insertion following external ventricular catheter (EVD) placement, (3) shunt insertion in a patient with another implanted cerebral shunt, (4) shunt insertion after central nervous system (CNS) infection, (5) emergency shunt insertion, (6) shunt procedures other than VPS (cystoperitoneal, subduroperitoneal, ventriculosubgaleal, ventriculoatrial etc., (7) non-adherence to the shunt protocol, and (8) patients without six months of follow-up.

Data Collection

For the period of 2011–2021, medical files of eligible patients were retrospectively explored and data were collected from operative notes, inpatients records, and outpatient visits. Extracted variables included age, sex, hydrocephalus etiology, VPS commercial brand, shunt valve, and ventricular catheter entry point. Outcome of patients, particularly shunt infection, was also extracted. In case of incomplete records, a phone call was attempted with the patients or their guardians.

Primary outcome measure

The primary outcome was shunt infection within the first postoperative 6 months, defined as: (1) Positive Gram stain or culture of CSF, (2) CSF pleocytosis with clinical symptoms of intracranial pressure or shunt malfunctioning (3) shunt erosion or exposure, (4) pseudocyst formation in the abdominal cavity [17]. We did not have the pre-protocol infection rate for all groups of shunted patents to compare with the results of this series. Instead, the results were compared with the rate of shunt infection in a series of infants who underwent shunting in the same center between 2003 and 2006 [27], and also with the results of other studies from developed and developing countries.

Statistical Analysis

Descriptive statistics were reported as median, interquartile range (IQR), range, mean, standard deviation, frequencies, and percentages. Pearson chi-square test and Mann-Whitney U-test were used to compare categorical and numeric variables, respectively. A p-value of less than 0.05 was considered significant. Variables marginally associated with shunt infection in univariate analyses (p-value < 0.2) were planned to entered multivariate logistic regression model. Statistical analyses were performed using R Studio (R Foundation) version 4.1.2.

A total number of 630 patients underwent VPS insertion between 2011 and 2021, of which 413 patients underwent their first VPS implantation, and 352 patients fulfilled the inclusion criteria of this study (Table-1). The median age was 5 months, with an interquartile range (IQR) of 3-12.2 months, and 46.3% of the patients were female (Table-1). The most common etiology of hydrocephalus was intraventricular hemorrhage (IVH) (34.9%), followed by congenital hydrocephalus (31.0%) and tumor (15.4%).

Shunt outcome

Of the 352 patients, 37 (10.5%) experienced shunt infection, with 30 (8.5%) occurring within the six months after the procedure. The 6-month infection rate was lower in the current series compared to the formerly published series of infants who were shunted in the same center between 2003 and 2006 (8.5% Vs. 13.3%)[27]. On the other hand, the rate was higher than those of HCRN first and second reports in 2011 and 2016 (5.7% and 6.0% respectively)[16, 17].

The median (IQR) time to shunt infection was 2.1 (0.1–57) months after shunt insertion (Table-2). Shunt infection rates demonstrated a downward trend over the study period (Figure-2).

Among all 37 shunt infections, 14 (37.8), 12 (32.45%), and 1 (2.7%) were diagnosed by CSF culture, cell count, and smear, while shunt erosion/exposure and abdominal pseudocyst were detected in 7 (18.9%) and 3 (8.1%) cases, respectively (Table-2). S. epidermidis, E. coli, and C. albicans were the most common pathogens, each accounting for 3 cases (11.1%).

Patients with VPS infection were significantly younger (P < 0.001). No significant correlation was found between shunt infection and other variables, including sex, hydrocephalus etiology, VPS commercial brand, valve type, and proximal catheter entry point. patients with VPS infection experienced higher shunt revision rates (P = 0.022) following the first VPS than those without infection. both groups were comparable in other baseline variables (Table-1).

Regression Analyses

Multivariate analyses were not performed since only one variable (i.e., age) had association with the primary outcome. No other variables had even a weak association (P < 0.2) with shunt infection. Regression models demonstrated that patients' age independently correlated with shunt infection (odds ratio 0.97 [95% confidence intervals 0.92–0.99], P = 0.026).

The morbidity and mortality associated with shunt infection is a significant concern. As most shunt infections occur intraoperatively[9], prompting the development of standardized protocols aimed at reducing such occurrences. Despite the differences in the components of the protocols, various studies have demonstrated that adherence to a standardized protocol leads to a decrease in infection rates. Within the last decades, protocols used in KBC Zagreb University Hospital in Croatia, protocol of des Enfants Hospital in France, no-touch technique protocol of University of Florida Health Science Center, sterile protocol of Erasme Hospital of Belgium, Calgary Shunt Protocol, protocol of Great Ormond Street Hospital, and HCRN protocols, could significantly reduce the rate of shunt infection[4, 10, 16, 17, 29, 30, 32, 38, 44]. Even though, it remained unclear whether the results of adhering to a standardized protocol could be generalized to centers in LMICs, with lower standards of care and hygiene. To address this gap, this study proposed an institutional protocol, established based on the published evidence, to fit the available resources and infrastructures. The results of the study demonstrated that adhering to the adapted protocol (figure-1) resulted in the 6-month infection rate of 8.5% and overall infection rate of 10.5%, following first-time VPS insertion in a high-volume center of a LMIC. Although no pre-protocol rate is available for comparison, the 6-month infection rate of 13.3% in a series of infants who formerly underwent VP shunting in this center was used as a reference for comparison[27]. Although, it cannot be determined whether this decreased rate is attributable to either amendment of protocol or improved attitude of surgical staff about preserving sterility.

Importantly, patient age at the time of surgery was the only variable which was independently associated with shunt infection, consistent with previous studies investigating shunt infection risk factors [9, 38, 41]. Patients who experienced shunt infection following first-time VPS insertion had a significantly higher number of further inserted shunts and revision rates, underscoring the potential burden of such complications on both the healthcare system and patients.

Institutional modified Protocol compared to HCRN protocol

Our study introduced some additional items to those outlined in the HCRN protocols [16, 17].

The air conditioner was turned off before surgical site preparation and unpacking surgical instruments. The effect of different air conditioner systems on surgical site infections is debated. The working principle of standard systems is the suction of operation room air and introduction of filtered air to the operation room [40, 43]. but such air filters are lacking in the ventilation systems used in our center. Although modern laminar flow air conditioning systems have been shown to reduce airborne bacteria [40, 43], conventional air conditioning systems utilized in our center may cause higher infection risk. Hence, the air conditioner keeps off during the procedure. Otherwise, the lack of air filtering in proper directions, which theoretically helps reducing the burden of airborne bacteria, would have acted as a factor increasing the rate of infection in our series.

Suction devices were not utilized throughout the procedure, since it was assumed that suction devices would have high rates of bacterial colonization which increases the risk of surgical field contamination [19, 31]. However, there is no strong evidence to show that removing suction devices has any independent role in reducing postoperative infection.

In HCRN protocols, chlorhexidine and isopropyl alcohol were used for preoperative skin disinfection [16, 17, 44]. In the current study, Povidone-iodine was utilized as the main disinfectant for surgical site preparation due to lower cost and better accessibility, added to the broad spectrum of coverage [22]. Though the potential risk of neurotoxicity of chlorhexidine has been previously proposed [8, 24], disinfectant agents never come to direct contact with nervous tissues during shunt surgeries, and chlorhexidine has been safely used by HCRN groups and other centers. Several studies had demonstrated that chlorohexidine was superior disinfectant to povidone-iodine for preoperative disinfection [8, 24, 26]. Accordingly, the study on Calgary Protocol proved that chlorhexidine was associated with fewer shunt infections than iodine-based skin preparation [44]. Consequently, one probable reason for more shunt infections in our center could be applying povidone-iodine instead of chlorohexidine/alcohol. Nevertheless, Okamura et al applied povidone-iodine as the disinfectant agent, and demonstrated no shunt infection after shunt protocol administration [28]. Therefore, a definitive verdict about this issue requires further studies.

Preoperative antibiotic administration has been recommended by World Health Organization (WHO) as a component of the surgical safety checklist [6, 4]. Intravenous cefazoline is the most frequently used prophylactic preoperative antibiotic for neurosurgical procedures [2]. Considering the 30-minute interval to culminate following intravenous injection [21], we administered cefazoline 30 minutes prior to skin incision and continued 24 hours postoperatively. The adapted protocol recommended impregnating the shunt devices in antibiotic (Gentamycin), added to injection into shunt system just before implantation. Nevertheless, antibiotic-impregnated catheters (AICs) are not routinely available in our center and the whole country. There are controversial results about the role of AICs in preventing shunt infection. The first HCRN protocol in 2011 did not offer AICs [17]. In 2016, the simplified 5-step protocol plus AICs showed the same infection rate as the first protocol [16]. Subsequently in 2019, Calgary Shunt Protocol, an external validation of HCRN protocol, showed that the types of ventricular catheters, including antibiotic impregnated or barium impregnated types, were not independently associated with fewer shunt infections [44]. Concurrently, perioperative protocol in Great Ormond Street Hospital incorporated AICs, and the protocol decreased the overall infections rare with no report for independent role of AICs [29]. In 2022, the third further simplified 5-step HCRN protocol, with optional use of AICs, demonstrated that AICs was significantly associated with the lower infection rate [5]. Regardless the mentioned controversial results, the lack of AICs can be a potential culprit for higher shunt infection rate in the current series.

The rate of shunt infection in the current series compared to series of other countries

The 6-month and overall shunt infection rate in this study was 8.5% and 10.5% respectively, which is consistent with studies conducted in developing countries with the infection rates of 9–13.8%[12, 18, 42]. The 6-month infection rate in a series of young infants who underwent shunt implantation in our center between 2003 and 2006 was 13.3%[27]. While a set of protection strategies was routinely followed at that era, the rate of infection has reduced in the current series. Nevertheless, the infection rate in our center is higher than the rates reported from developed countries including centers collaborating with HCRN group [5, 16, 17]. The pre-protocol infection rate in HCRN reports was 8.7% which reduced to 5.7% after the first protocol and remained at 6.0% by employing the second protocol [16, 17]. Hence, the rate of infection control in our center is similar to the pre-protocol rate of HCRN centers. There are some proposed causes for this difference, including patient’s backgrounds, difference in the overall level of hygiene, different description of infection, difference in compliance with protocol, and dissimilar materials and surgical equipment.

One possible cause of this discrepancy might be younger age of patients in this study. It is established that younger age at the time of surgery significantly correlates with the risk of shunt infection [7, 9, 41]. Therefore, the younger age of the patients (median: 5 months versus 5.2 years in the HCRN study)[17] might have acted in the opposite direction of positive effects of implementing a standardized shunt protocol. Furthermore, there was a high prevalence of hydrocephalus due to IVH of prematurity (34.9%) in the current series. Though neither original nor further HCRN studies reported the frequency of IVH of prematurity in their sample population, IVH has been previously proposed as a risk factor and might have contributed to the higher infection rates in this study.

The next probable cause can be related to the definition of shunt infection. According to HCRN, shunt infection was defined as positive CSF culture or gram stain, shunt erosion, and abdominal pseudocyst [16]. We also considered patients with anomalous CSF pleocytosis with symptoms of intracranial hypertension or shunt malfunctioning, regardless of microorganism detection.

The further possible cause of higher infection rate in the current series would be the different degrees of adherence to the protocol and the staff compliance over the time. Considering the presence of new surgical staff over time, the probable different compliance rates between this study and previous literature might be another possible reason for the higher infection rate. Though, the compliance rates for each step of the protocol were not recorded in this study. Instead, the overall protocol adherence was checked, and the procedures without overall adherence to the protocol were excluded.

The differences might originate from limitations in material and equipment. Lack of AICs and chlorhexidine disinfection were earlier discussed [5, 16, 17, 44]. Moreover, some other equipment, like disposable tunnellers, are lacking in our center. Though, the role of such devices has not been assessed so far, it can be a topic for further researches. The overall level of hygiene and social determinants of health, including socioeconomic conditions, could be of value as well.

The microorganisms of shunt infection

In line with the previous studies[11, 23, 44], staphylococci and gram-negative bacilli were the most common pathogens. However, this study highlighted a high number of shunt infections by C. albicans. One of the most common source of candida infection would be colonization of EVD [3]. However, those with prior EVD placement were excluded from this study. The Predominance of IVH of prematurity in this series is another factor which may contributed to this finding[1, 25]. Other well-known causes for candida shunt infection include excessive use of broad-spectrum antibiotics, immunocompromised state, and indwelling urinary and central venous catheters [1, 25], which were not accessible for analyses in this retrospective study.

Downward trend of shunt infection over time

One important finding of this study was the downward trend of shunt infection between 2011 and 2021 (Figure-2). Moreover, the infection rate in the current series was lower compared to the former series performed between 2003 and 2006[27]. This downward trend is comparable with other studies. The original HCRN shunt protocol study demonstrated that compliance rates to the shunt protocol gradually increased during the study period [16, 17]. Though the exact rates of compliance with individual protocol steps were not recorded in this study, the observed downward trend might be due to the increasing proficiency of the surgical team with the protocol steps.

Limitation and drawbacks

This study is subject to inherent drawbacks of the retrospective design, including retrospective data collection in a single high-volume center which made it susceptible to selection bias. The study was single-arm, and historical literature was used to compare the results. The compliance rate to each step of the protocol was not recorded, but the overall protocol adherence was checked and the procedures without overall adherence to the protocol were excluded. Considering the rarity of the primary outcome (37 cases), the regression analyses may lack enough statistical power.

Accordingly, future studies should check compliance rates for each step of the protocol and assess the correlation of each with shunt infection. Furthermore, assessing the compliance rates for each step to each surgical member may enhance their performance and increase the compliance to the protocol. Conducting multi-center studies may reveal the extent of generalizability of these findings to low- and medium-volume centers in different regions of the country. The consequent increase in sample size will also increase the frequency of the primary outcome and improve the statistical power of the regression analyses.

This study demonstrated that adhering to a step-by-step protocol in a high-volume medical center, in a LMIC, could maintain low shunt infection rates, roughly comparable to high-income countries. This accomplishment was achieved by implementing a modified protocol, adapted from the available evidence to suit the healthcare resources and financial constraints of LMICs. Such modified protocols could act as low-cost solutions to overcome the unavoidable shortcomings in the operating theatres and care systems of the lower-resource neurosurgery world.

The results of analyses also once again confirmed that the patients’ age at the time of surgery had a significant correlation with shunt infection. However, sex, hydrocephalus etiology, and VPS characteristics did not exhibit a significant correlation with shunt infection.

Ethics approval

Institutional ethical approval Code; IR.TUMS.CHMC.REC.1400.183. The study adhered to the tenets of the Declaration of Helsinki.

Consent to participate

Informed consent to use clinical data for research purposes had been taken from parents at admission time.

Consent for publication

Consent for publication was taken from parents, conditioning that the patients’ identity is not recognizable.

Availability of data and material

Queries about the data should be directed to the corresponding author.

Competing interests

The authors have no conflict of interest/competing interest.

Funding

The study received no funding.

Authors' contributions

Data gathering, Statistical analysis, Contribution to drafting; (Ataollah Shahbandi), Contribution to drafting; (Pedram Jahangiri), Critically revising the manuscript; (Keyvan Tayebi Meybodi), Contribution to drafting; (Faezeh Aghajani), Supervision; (Farideh Nejat), Conceptualization, Interoperation of data, Final approval; (Zohreh Habibi)

Acknowledgements

N/A

No funding was received to assist with the preparation of this manuscript, and the authors have no conflict of interest/competing interest.

Adams DJ, Rajnik M (2014) Microbiology and Treatment of Cerebrospinal Fluid Shunt Infections in Children. Curr Infect Dis Rep 16:427. doi: 10.1007/s11908-014-0427-8
Brown EM (1993) Antimicrobial prophylaxis in neurosurgery. Journal of Antimicrobial Chemotherapy 31:49–63
Caceres A, Avila ML, Herrera ML (2018) Fungal infections in pediatric neurosurgery. Child’s Nervous System 34:1973–1988
Choux M, Genitori L, Lang D, Lena G (1992) Shunt implantation: reducing the incidence of shunt infection. J Neurosurg 77:875–880
Chu J, Jensen H, Holubkov R, Krieger MD, Kulkarni A V, Riva-Cambrin J, Rozzelle CJ, Limbrick DD, Wellons JC, Browd SR (2022) The Hydrocephalus Clinical Research Network quality improvement initiative: the role of antibiotic-impregnated catheters and vancomycin wound irrigation. J Neurosurg Pediatr 29:711–718
Classen DC, Evans RS, Pestotnik SL, Horn SD, Menlove RL, Burke JP (1992) The timing of prophylactic administration of antibiotics and the risk of surgical-wound infection. New England Journal of Medicine 326:281–286
Dallacasa P, Dappozzo A, Galassi E, Sandri F, Cocchi G, Masi M (1995) Cerebrospinal fluid shunt infections in infants. Child’s Nervous System 11:643–649
Darouiche RO, Wall Jr MJ, Itani KMF, Otterson MF, Webb AL, Carrick MM, Miller HJ, Awad SS, Crosby CT, Mosier MC (2010) Chlorhexidine–alcohol versus povidone–iodine for surgical-site antisepsis. New England Journal of Medicine 362:18–26
Erps A, Roth J, Constantini S, Lerner‐Geva L, Grisaru‐Soen G (2018) Risk factors and epidemiology of pediatric ventriculoperitoneal shunt infection. Pediatrics International 60:1056–1061
Faillace WJ (1995) A no-touch technique protocol to diminish cerebrospinal fluid shunt infection. Surg Neurol 43:344–350
Forward KR, Fewer HD, Stiver HG (1983) Cerebrospinal fluid shunt infections: a review of 35 infections in 32 patients. J Neurosurg 59:389–394
Gathura E, Poenaru D, Bransford R, Albright AL (2010) Outcomes of ventriculoperitoneal shunt insertion in Sub-Saharan Africa. J Neurosurg Pediatr 6:329–335
González S, Carbonaro M, Fedullo AG, Sormani MI, Ceinos M del C, Biochemistb RG, Rosanova MT (2018) Cerebrospinal fluid shunt-associated infections in pediatrics: Analysis of the epidemiology and mortality risk factors. Arch Argent Pediatr 116:198–203
Haynes AB, Weiser TG, Berry WR, Lipsitz SR, Breizat A-HS, Dellinger EP, Herbosa T, Joseph S, Kibatala PL, Lapitan MCM (2009) A surgical safety checklist to reduce morbidity and mortality in a global population. New England journal of medicine 360:491–499
Kestle JRW, Garton HJL, Whitehead WE, Drake JM, Kulkarni A v, Cochrane DD, Muszynski C, Walker ML (2006) Management of shunt infections: a multicenter pilot study. J Neurosurg Pediatr 105:177–181
Kestle JRW, Holubkov R, Cochrane DD, Kulkarni A V, Limbrick DD, Luerssen TG, Oakes WJ, Riva-Cambrin J, Rozzelle C, Simon TD (2016) A new Hydrocephalus Clinical Research Network protocol to reduce cerebrospinal fluid shunt infection. J Neurosurg Pediatr 17:391–396
Kestle JRW, Riva-Cambrin J, Wellons JC, Kulkarni A V, Whitehead WE, Walker ML, Oakes WJ, Drake JM, Luerssen TG, Simon TD (2011) A standardized protocol to reduce cerebrospinal fluid shunt infection: the Hydrocephalus Clinical Research Network Quality Improvement Initiative. J Neurosurg Pediatr 8:22–29
Lane JD, Mugamba J, Ssenyonga P, Warf BC (2014) Effectiveness of the Bactiseal Universal Shunt for reducing shunt infection in a sub-Saharan African context: a retrospective cohort study in 160 Ugandan children. J Neurosurg Pediatr 13:140–144
Larsson J, Sutherland S, Söderström Å, Roman-Emanuel C, Jeppsson A, Olofsson EH, Svensson P-A (2015) Bacterial contamination of suction catheter tips during aortic valve replacement surgery: a prospective observational cohort study. Patient Saf Surg 9:1–5
Leaper DJ, Edmiston CE (2017) World Health Organization: global guidelines for the prevention of surgical site infection. Journal of Hospital Infection 95:135–136
Lee FH, Pfeffer M, Van Harken DR, Smyth RD, Hottendorf GH (1980) Comparative pharmacokinetics of ceforanide (BL-S786R) and cefazolin in laboratory animals and humans. Antimicrob Agents Chemother 17:188–192
Mangram AJ, Horan TC, Pearson ML, Silver LC, Jarvis WR, Committee HICPA (1999) Guideline for prevention of surgical site infection, 1999. Infect Control Hosp Epidemiol 20:247–280
McGirt MJ, Zaas A, Fuchs HE, George TM, Kaye K, Sexton DJ (2003) Risk Factors for Pediatric Ventriculoperitoneal Shunt Infection and Predictors of Infectious Pathogens. Clinical Infectious Diseases 36:858–862. doi: 10.1086/368191
Mimoz O, Lucet J-C, Kerforne T, Pascal J, Souweine B, Goudet V, Mercat A, Bouadma L, Lasocki S, Alfandari S (2015) Skin antisepsis with chlorhexidine–alcohol versus povidone iodine–alcohol, with and without skin scrubbing, for prevention of intravascular-catheter-related infection (CLEAN): an open-label, multicentre, randomised, controlled, two-by-two factorial trial. The Lancet 386:2069–2077
Montero A, Romero J, Vargas JA, Regueiro CA, Sanchez-Aloz G, De Prados F, De la Torre A, Aragon G (2000) Candida infection of cerebrospinal fluid shunt devices: report of two cases and review of the literature. Acta Neurochir (Wien) 142:67–74
Muram S, Isaacs AM, Sader N, Holubkov R, Fong A, Conly J, Hamilton MG (2022) A standardized infection prevention bundle for reduction of CSF shunt infections in adult ventriculoperitoneal shunt surgery performed without antibiotic-impregnated catheters. J Neurosurg 1:1–9
Nejat F, Tajik P, Ghodsi SM, Golestan B, Majdzadeh R, Yazdani S, Ansari S, Dadmehr M, Ganji S, Najafi M (2008) Breastfeeding: a potential protective factor against ventriculoperitoneal shunt infection in young infants. J Neurosurg Pediatr 1:138–141
Okamura Y, Maruyama K, Fukuda S, Horikawa H, Sasaki N, Noguchi A, Nagane M, Shiokawa Y (2019) Detailed standardized protocol to prevent cerebrospinal fluid shunt infection. J Neurosurg 132:755–759
Omrani O, O’Connor J, Hartley J, James G (2018) Effect of introduction of a standardised peri-operative protocol on CSF shunt infection rate: a single-centre cohort study of 809 procedures. Child’s Nervous System 34:2407–2414
Pirotte BJM, Lubansu A, Bruneau M, Loqa C, Van Cutsem N, Brotchi J (2007) Sterile surgical technique for shunt placement reduces the shunt infection rate in children: preliminary analysis of a prospective protocol in 115 consecutive procedures. Child’s Nervous System 23:1251–1261
Robinson AH, Drew S, Anderson J, Bentley G, Ridgway GL (1993) Suction tip contamination in the ultraclean-air operating theatre. Ann R Coll Surg Engl 75:254
Rotim K, Miklic P, Paladino J, Melada A, Marcikic M, Scap M (1997) Reducing the incidence of infection in pediatric cerebrospinal fluid shunt operations. Child’s Nervous System 13:584–587
Sciubba DM, Lin L-M, Woodworth GF, McGirt MJ, Carson B, Jallo GI (2007) Factors contributing to the medical costs of cerebrospinal fluid shunt infection treatment in pediatric patients with standard shunt components compared with those in patients with antibiotic-impregnated components. Neurosurg Focus 22:1–4
Simon TD, Butler J, Whitlock KB, Browd SR, Holubkov R, Kestle JRW, Kulkarni A v, Langley M, Limbrick Jr DD, Mayer-Hamblett N (2014) Risk factors for first cerebrospinal fluid shunt infection: findings from a multi-center prospective cohort study. J Pediatr 164:1462–1468
Simon TD, Hall M, Dean JM, Kestle JRW, Riva-Cambrin J (2010) Reinfection following initial cerebrospinal fluid shunt infection. J Neurosurg Pediatr 6:277–285
Simon TD, Kronman MP, Whitlock KB, Gove NE, Mayer-Hamblett N, Browd SR, Cochrane DD, Holubkov R, Kulkarni A V, Langley M (2018) Reinfection after treatment of first cerebrospinal fluid shunt infection: a prospective observational cohort study. J Neurosurg Pediatr 21:346–358
Simon TD, Riva-Cambrin J, Srivastava R, Bratton SL, Dean JM, Kestle JRW (2008) Hospital care for children with hydrocephalus in the United States: utilization, charges, comorbidities, and deaths. J Neurosurg Pediatr 1:131–137
Spader HS, Hertzler DA, Kestle JRW, Riva-Cambrin J (2015) Risk factors for infection and the effect of an institutional shunt protocol on the incidence of ventricular access device infections in preterm infants. J Neurosurg Pediatr 15:156–160
Tamber MS, Klimo P, Mazzola CA, Flannery AM (2014) Pediatric hydrocephalus: systematic literature review and evidence-based guidelines. Part 8: Management of cerebrospinal fluid shunt infection. J Neurosurg Pediatr 14:60–71
Turner RS (1974) Laminar air flow: its original surgical application and long-term results. JBJS 56:430–435
Vinchon M, Dhellemmes P (2006) Cerebrospinal fluid shunt infection: risk factors and long-term follow-up. Child’s Nervous System 22:692–697
Warf BC (2005) Comparison of 1-year outcomes for the Chhabra and Codman-Hakim Micro Precision shunt systems in Uganda: a prospective study in 195 children. J Neurosurg Pediatr 102:358–362
Weiser MC, Moucha CS (2018) Operating-room airflow technology and infection prevention. JBJS 100:795–804
Yang MMH, Hader W, Bullivant K, Brindle M, Riva-Cambrin J (2019) Calgary Shunt Protocol, an adaptation of the Hydrocephalus Clinical Research Network shunt protocol, reduces shunt infections in children. J Neurosurg Pediatr 23:559–567

Table 1. Baseline characteristics of the patients

Variable

Infected (n=37)

Not infected (n=315)

Total (n=352)

p-value

Age, months

Median (IQR)

Mean ± SD

5 (3-11)

17.48 ± 30.35

3 (5-14.5)

7.48 ± 7.55

5 (3-12.25)

16.43 ± 28.97

<0.001

Sex, n (%)

Male

Female

19 (51.4)

18 (48.6)

170 (54.0)

145 (46.0)

189 (53.7)

163 (46.3)

0.763

Etiology, n (%)

Post-IVH

Congenital/obstructive

Tumor

MMC

Arachnoid cyst

Trauma

Vascular malformation

Complex craniofacial syndromes^*

Post-ischmic HCP

IIH

15 (40.6)

9 (24.3)

3 (8.1)

7 (18.9)

2 (5.4)

0

1 (2.7)

0

108 (34.3)

100 (31.8)

51 (16.2)

31 (9.8)

14 (4.4)

4 (1.3)

2 (0.6)

3 (0.9)

1 (0.3)

123 (34.9)

109 (31.0)

54 (15.4)

38 (10.8)

16 (4.5)

4 (1.1)

2 (0.6)

4 (1.2)

1 (0.3)

0.384

Shunt inserted per patient, n

Median (range)

Mean ± SD

1 (1-3)

1.49 ± 0.69

1 (1-3)

1.09 ± 0.33

1 (1-3)

1.16 ± 0.45

<0.001

VPS commercial brand^**, n (%)

Medtronic

Codman

Integra

Miethke

18 (52.9)

11 (32.3)

5 (14.8)

0

170 (56.4)

85 (28.1)

46 (15.2)

1 (0.3)

188 (55.9)

96 (28.6)

51 (15.2)

1 (0.3)

0.972

Valve type^***, n (%)

Static pressure gradient

Programmable

25 (73.5)

9 (26.5)

211 (73.3)

77 (26.7)

236 (73.3)

86 (26.7)

0.974

Ventricular catheter entry point^****, n (%)

Occipital

Frontal

33 (91.7)

3 (8.3)

279 (90.0)

31 (10.0)

312 (90.2)

34 (9.8)

0.988

IQR, interquartile range. SD, standard deviation. IVH, intraventricular hemorrhage. MMC, myelomeningocele. DWM, Dandy-Walker malformation. HCP, hydrocephalus. IIH, idiopathic intracranial hypertension. VPS, ventriculoperitoneal shunt

^*Complex craniofacial syndromes included 2 cases of Osteopetrosis, 1 Crouzon syndrome and 1 Mucopolysaccharidosis.

^** Commercial brand of 16 ventriculoperitoneal shunts could not be retrieved from the operative notes.

^*** Valve type of 30 ventriculoperitoneal shunts could not be retrieved from the operative notes

^**** Ventricular catheter placement could not be retrieved for 6 procedures

Table 2. Study Outcomes

Variable	Infected (n=37)	Not infected (n=315)	Total (n=352)	p-value
First six months postoperative shunt infection rate, n (%)	30 (8.5)	N/A	N/A	N/A
Overall shunt infection rate, n (%)	37 (10.5)	N/A	N/A	N/A
Time to infection, months, median (range)	2.1 months (0.1-57)	N/A	N/A	N/A
Further Shunt revision, n (%) Yes No	10 (27.0) 27 (73.0)	41 (13.0) 274 (87.0)	51 (14.5) 301 (85.5)	0.022
Method of shunt infection detection (%) Culture Smear Cell count Shunt erosion/exposure Abdominal pseudocyst	14 (37.8) 1 (2.7) 12 (32.4) 7 (18.9) 3 (8.1)
Pathogen detected in CSF S. Epidermidis E. coli C. Albicans A. baumannii Methicillin-sensitive S. Aureus Methicillin-resistant S. Aureus P. aeruginosa E. Faecalis Not detected	3 (11.1) 3 (11.1) 3 (11.1) 2 (7.4) 1 (3.7) 1 (3.7) 1 (3.7) 1 (3.7) 12 (44.5)

No competing interests reported.

Implementation of an adapted perioperative ventriculoperitoneal shunting protocol in a tertiary center located in a low-to-middle-income country

Status:

Journal Publication

Version 1

Abstract

Objective

Methods

Results

Conclusions

Figures

Introduction

Methods

Study settings

Eligibility Criteria

Data Collection

Primary outcome measure

Statistical Analysis

Results

Shunt outcome

Regression Analyses

Discussion

Institutional modified Protocol compared to HCRN protocol

The rate of shunt infection in the current series compared to series of other countries

The microorganisms of shunt infection

Downward trend of shunt infection over time

Limitation and drawbacks

Conclusion

Declarations

References

Tables

Additional Declarations

Status:

Journal Publication

Version 1