case study of surgical site infection

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Published: 29 September 2016

A case report of a deep surgical site infection with Terrisporobacter glycolicus/T. Mayombei and review of the literature

Matthew P. Cheng 1 , 3 ,
Marc-Christian Domingo 2 ,
Simon Lévesque 2 &
Cedric P. Yansouni 1 , 3

BMC Infectious Diseases volume 16 , Article number: 529 ( 2016 ) Cite this article

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There are increasing data regarding Terrisporobacter glycolicus as an emerging anaerobic pathogen. However, the few published cases to date usually report it as part of a polymicrobial infection. Here, we describe the first reported monomicrobial surgical site infection with this bacterium. Identification methods, taxonomy, and clinical management of this rarely identified pathogen are also discussed.

Case presentation

A previously healthy 66-year-old sustained an open olecranon fracture of his left arm after trauma. He subsequently underwent open reduction and internal fixation (ORIF), with insertion of an olecranon locking plate and two locking screws. Ten days after surgery, the patient developed increasing pain at the surgical site and noted green discharge from the wound. Culture of the wound discharge yielded grew a pure Gram-positive anaerobe identified by the RapidANA® microbial identification system as C. difficile (profile 000010, 99.1 % probability). Reference laboratory testing identified the isolate as T. glycolicus/mayombei (previously designated as Clostridium glycolicum/mayombei) by 16S rRNA gene sequencing and as Clostridium glycolicum by MALDI-TOF mass spectrometry. The patient received an 8-week course of moxifloxacin and metronidazole with an excellent clinical response at 12 months’ follow-up.

Conclusions

We describe the case of a deep surgical site infection with T. glycolicus/mayombei (formerly known as Clostridium glycolicum and Clostridium mayombei , respectively), which extends our knowledge of the clinical spectrum of this pathogen . The isolate was misidentified by phenotypic identification methods.

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Clostridium spp . are a heterogeneous group of anaerobic, spore-forming, gram-positive rod-shaped bacteria. Over 200 distinct species have been identified, most of which are environmental organisms; few species have been recognized to cause clinical disease [ 1 ]. There are increasing data regarding Terrisporobacter glycolicus & Terrisporobacter mayombei as emerging anaerobic pathogens, yet relatively little is known about their pathogenic potential. Previous case reports of C. glycolicum (the former designation of T. glycolicus ) identified the bacteria in cultures of wounds and blood, often in conjunction with other pathogens [ 2 – 4 ]. Although it has been implicated in bloodstream infections, brain abscesses as well as bone and joint infections, its ideal method of identification has yet to be determined.

We describe the first reported monomicrobial surgical site infection with prosthetic material from T. glycolicus / T. mayombei . Phenotypic identification systems used in our laboratory at the time of the case identified it as C. difficile, but 16S ribosomal sequence analysis yielded T. glycolicus/T. mayombei with a high degree of certainty. In addition, MALDI-TOF MS system demonstrated the ability to correctly identify C. glycolicum , under its former designation.

A previously healthy 66-year-old man fell off of his bicycle onto dry pavement, and sustained an open olecranon fracture of his left arm. He subsequently underwent open reduction and internal fixation (ORIF), with insertion of an olecranon locking plate and two locking screws. Chlorhexidine-based sterilizing solution and peri-operative cefazolin were used in accordance with our institution’s protocols. The procedure was uncomplicated and the patient was discharged home on the third post-operative day.

Ten days after surgery, the patient developed increasing pain at the surgical site and noted green discharge from the wound. He was re-admitted to hospital for surgical drainage of the affected elbow, and piperacillin-tazobactam was prescribed empirically. Culture of the wound discharge yielded anaerobic spore-forming Gram-positive rods in broth media and anaerobic 5 % sheep blood agar, identified by the RapidANA® microbial identification system as C. difficile (profile 000010, 99.1 % probability). The aerobic cultures were negative. Given the rarity of C. difficile joint infections [ 5 , 6 ], was reported as “ Clostridium species” and the isolate was sent to the provincial reference laboratory for speciation. Our patient did not have any evidence of C. difficile -associated diarrhea and his stool specimen was negative for C. difficile toxin by PCR. He was subsequently treated with intravenous vancomycin and oral metronidazole, pending results of antimicrobial susceptibility testing.

At the Laboratoire de santé publique du Québec (LSPQ), latex agglutination (Microgen Bioproducts Ltd) yielded a positive result indicating a possible C. difficile strain. However, according to the manufacturer package insert, C. glycolicum is known to cross react with this reagent. The isolate was identified as C. glycolicum by MALDI-TOF mass spectrometry using the bioMérieux VITEK MS system (IVD database version 2.0). The clinical isolate, designated LSPQ-04251, was definitively identified by 16S rRNA gene sequencing using a BigDye method with ABI3130 XL sequencing (Applied Biosystems, Foster City, CA). Pairwise nucleotide sequence similarities of the 16S rRNA gene indicated that the closest known relatives of the isolate were Clostridium glycolicum (99.3 %) (recently reclassified as Terrisporobacter glycolicus ), and Clostridium mayombei (99.2 %) (recently reclassified as Terrisporobacter mayombei ) [ 7 ]. Based on the 16S rRNA gene sequence comparison, T. glycolicus and T. mayombei were genetically highly related, displaying 99.4 % sequence similarities with 0.6 % divergence. No further characterization of isolate LSP-04251 to separate both species T. glycolicus and T. mayombei , (requiring additional analysis of the genomic DNA G + C content, predominant cellular fatty acids and products from peptone yeast extract) was performed [ 7 ].

As there is little experience with clinical infections from these bacteria [ 8 ], we relied on minimal inhibitory concentration (MIC) determination by Etest®, according to the manufacturer’s application guide, to guide antimicrobial treatment (see Table 1 ). Treatment was changed to oral moxifloxacin and metronidazole due to logistical barriers to intravenous therapy in this patient and their excellent bioavailability and bone penetration [ 9 , 10 ], for a total of 8 weeks. One year after stopping antibiotics, the patient was well, without signs of recrudescent infection.

Surgical site infections are an important complication of open fractures, and this risk is modulated by several variables including the size of the wound, the complexity of the fracture, and the presence of necrotic soft tissue [ 11 ]. Our patient’s wound was classified as Gustilo Type II (i.e. open fracture with a laceration <1 cm in length without extensive soft tissue damage, flaps, or avulsions) without severe contamination. No antimicrobial prophylaxis was given beyond the surgical procedure. It is most plausible that our patient’s wound was infected with T. glycolicum / T. mayombei at the time of his initial injury on the pavement. Although we cannot exclude haematogenous seeding from the gastrointestinal tract, this would seem unlikely given the circumstances of the accident, the organism identified and the absence of GI symptoms or underlying disease.

Although not currently assigned formally to the family Peptostreptococcaceae , phylogenetic analyses indicated that the species Terrisporobacter glycolicus and T. mayombei are members of the family Peptostreptococcaceae [ 7 ]. To support this classification in the family of Peptostreptococcaceae , Yutin and Galpieri compared a phylogenetic tree for a concatenated set of 50 widespread ribosomal proteins with the trees for beta subunits of the RNA polymerase (RpoB) and DNA gyrase (GyrB) genes and with the 16S rRNA-based phylogeny tree. The result of this analysis support placement of Clostridium difficile and its close relatives (including species of the genus Terrisporobacter ) within the family Peptostreptococcaceae . Hence, some have proposed to rename C. difficile as Peptoclostridium difficile, and to transfer C. glycolicum and C. mayombei to this genus as well [ 1 ]. This taxonomic controversy remains unresolved for the moment. Thus, based on available phylogenetic data, misidentification of the isolate LSPQ-04251 as C. difficile by phenotypic methods is not unexpected.

Relatively little is known about the pathogenic potential of T. glycolicus / T. mayombei. Elsayed and Zhang first reported a first case of human infection with C. glycolicum in 2007, when a 43 year old woman developed septic shock after a recent bone marrow transplant for relapsed Hodgkin’s disease [ 2 ]. Their patient was found to have a polymicrobial bactermia with C. glycolicum and Enterococcus spp . She received numerous antibiotics initially and subsequently completed a two-week course of ampicillin, gentamicin and metronidazole with a good clinical response. In 2009, Van Leer et al. described the case of a 62 year-old gentleman who developed a brain abscess with gas formation after otitis media, for which he treated himself with clay in his ear [ 4 ]. C. glycolicum was the only organism identified in the patient’s blood, but numerous other organisms were recovered from the pus and necrotic tissue from the mastoid. Their patient eventually recovered with residual bilateral hearing loss after surgical debridement of the infection. In 2012, Jiang et al. reported two cases of human infection of C. glycolicum after suffering accidental injuries. Both cases resulted in polymicrobial infections, with one patient developing a coagulase-negative staphylococcal bacteremia requiring six weeks of intravenous antibiotic therapy with vancomycin. Subsequently, Cai et al. described a case of a 67 year-old gentleman with numerous medical co-morbidities who developed acalculous cholecystitis and was found to have a bloodstream infection with C. glycolicum. No other pathogens were identified and the patient responded well to treatment with pipacillin-tazobactam.

We describe the first reported monomicrobial surgical site infection from T. glycolicus / T. mayombei . Sequence analysis of the 16S rRNA gene offers greater discrimination between genera and, in many cases, species compared to the other bacterial identification methods described in this report. However, MALDI-TOF mass spectrometry also correctly identified C. glycolicum under its former designation and may be a reliable identification method for these pathogens. Our case demonstrates the limitations of phenotypic identification systems for clostridial species, and extends our knowledge of the clinical spectrum of T. glycolicus / T. mayombei. Finally, species identification for deep Gram-positive anaerobic rod infections is pertinent because antimicrobial susceptibility patterns may be poorly characterised or variable, and mandate susceptibility testing for rarely encountered species.

Terrisporobacter glycolicus/Terrisporobacter mayombi is a rare cause of clinical infection, but has been implicated in brain abscesses, bone and joint infections, as well as bloodstream infections.

T. glycolicus/mayombi was misidentified as C. difficile by phenotypic and latex agglutination testing. Accurate identification was achieved with both 16S rRNA gene sequence analysis and MALDI-TOF MS.

Identification to the species level for deep Gram-positive anaerobic rod infections is potentially clinically pertinent, and rarely encountered species should prompt antimicrobial susceptibility testing.

Abbreviations

Matrix-assisted laser desorption/ionization – time of flight

miminal inhibitory concentration

Open reduction and internal fixation

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CPY holds a Chercheur-boursier clinicien career award from the Fonds de recherche du Québec – Santé (FRQS).

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Authors’ contributions

MPC and CPY provided clinical care for the patient. MPC performed literature searches and drafted the article. MCD performed 16S ribosomal sequence analysis. SL performed latex agglutination and MALDI-TOF MS analysis. CPY was responsible for the overall content. All authors read and approved the final manuscript.

Competing interests

SL has a research agreement with bioMérieux Canada for the utilization of VITEK MS system. All other authors declare that they have no competing interests.

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Matthew P. Cheng & Cedric P. Yansouni

Laboratoire de santé publique du Québec, McGill University Health Centre, Montreal, Canada

Marc-Christian Domingo & Simon Lévesque

J.D. MacLean Centre for Tropical Diseases, McGill University Health Centre, Montreal, Canada

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Cheng, M.P., Domingo, MC., Lévesque, S. et al. A case report of a deep surgical site infection with Terrisporobacter glycolicus/T. Mayombei and review of the literature. BMC Infect Dis 16 , 529 (2016). https://doi.org/10.1186/s12879-016-1865-8

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Open access
Published: 09 August 2024

Ventriculoatrial shunt remains a safe surgical alternative for hydrocephalus: a systematic review and meta-analysis

Enrico Lo Bue 1 na1 ,
Alberto Morello ORCID: orcid.org/0009-0004-7114-7787 1 na1 ,
Jacopo Bellomo 2 , 3 ,
Leonardo Bradaschia 1 ,
Filippo Lacatena 1 ,
Stefano Colonna 1 ,
Alessandro Fiumefreddo 1 ,
Lennart Stieglitz 2 , 3 ,
Luca Regli 2 , 3 ,
Michele Maria Lanotte 4 ,
Diego Garbossa 1 &
Fabio Cofano 1

Scientific Reports volume 14 , Article number: 18460 ( 2024 ) Cite this article

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Diseases of the nervous system
Neuroscience

Hydrocephalus is a commonly encountered pathology in the neurosurgical practice. Since the first permanent ventriculo-subarachnoid-subgaleal shunt described by Mikulicz in 1893, there were multiple attempts to find solutions for draining the excess production/less reabsorption of the cerebrospinal fluid (CSF) from the brain. Nowadays, the most common technique is the ventriculoperitoneal shunt (VPS), whereas the ventriculoatrial shunt (VAS) is applied only in some rare conditions. To date there are still no specific guidelines or strong evidence in literature that guide the surgeon in the choice between the two methods, and the decision usually relies on the confidence and expertise of the surgeon. Considering the lack of established recommendations, this systematic review and meta-analysis aims to evaluate the effectiveness and safety of these two shunting techniques. This systematic review was conducted following the PRISMA protocol (Preferred Reporting Items for Systematic Reviews and Meta-Analyses). No chronological limits of study publications were included. Prospective and retrospective clinical studies, and reports of case series with at least five patients per group and reporting data on comparison between VAS and VPS techniques were eligible for inclusion. Nine studies reporting 3197 patients meeting the inclusion and exclusion criteria were identified and included in the quantitative synthesis. The risk of shunt dysfunction/obstruction was significantly lower in the VAS group [odds ratio (OR) 0.49, 95%-CI 0.34–0.70, I 2 0%]. The risk of infection was not significantly different between the two groups (OR 1.02, 95%-CI 0.59–1.74, I 2 0%). The risk of revision was not significantly different between the two groups; however, the heterogeneity between the studies was significant (OR 0.73, 95%-CI 0.36–1.49, I 2 91%). Additionally, the risk of death was not significantly different between the two groups; however, the heterogeneity between the studies was high (OR 1.93, 95%-CI 0.81–4.62, I 2 64%). VAS remains a safe surgical alternative for hydrocephalus. The results of this study highlight a lower risk of shunt dysfunction/obstruction variable in the VAS group, with no significant statistical differences regarding the occurrence of at least one infection-related complication. In consequence, the choice between these two techniques must be tailored to the specific characteristics of the patient.

Protocol Registration : The review protocol was registered and published in Prospective Register of Systematic Reviews (PROSPERO) ( www.crd.york.ac.uk/PROSPERO ) website with registration number: CRD42023479365.

Risk factors for unfavourable outcomes after shunt surgery in patients with idiopathic normal-pressure hydrocephalus

Introduction and comparision of three different fixation methods in the suprahepatic space in laparoscopy-assisted ventriculoperitoneal shunt for hydrocephalus

Aqueductal CSF stroke volume measurements may drive management of shunted idiopathic normal pressure hydrocephalus patients

Introduction.

In the 1950s the creation of a valve system with the ability to regulate opening pressure and prevent CSF reflux in the brain initiated a new era of surgical treatments for hydrocephalus. Consequently, it led to the development of the ventriculoatrial shunt (VAS) in the 1960s 1 and the ventriculoperitoneal shunt (VPS) in the 1970s 2 . Originally, VAS was considered superior to VPS because of the polyethylene tube of the latter, which had unacceptable rates of peritonitis and distal failure. However, it was quickly noted that VAS carried significant concerns regarding the recognition of various serious and even fatal complications, such as atrial thrombi, pulmonary embolism, bacteremia, pulmonary hypertension, and cor pulmonale 3 .

Through the years, VPS has steadily gained ground compared to VAS due to a multitude of factors, including the simplicity of the surgical technique and a faster learning curve. In addition, the high peritoneal absorptive capacity, as demonstrated by its use in peritoneal dialysis, allows the placement in pediatric population of additional length of catheter for growth avoiding lengthening procedures 4 . Additionally, VAS represents a last resort treatment for hydrocephalus, notably when VPS is not feasible. Furthermore, VAS may be underutilized due to the technical preferences of neurosurgeon, and less tendency of young neurosurgeons to learn and master the technical procedure 5 .

To the best of the author’s knowledge, there are no clear guidelines clarifying the use of VAS or VPS as first surgical solution for shunt placement, demanding the choice to the surgeon or to internal guidelines of each institution. Since the lack of established recommendation, this systematic review and meta-analysis aims to evaluate the effectiveness and safety of these two shunting techniques.

Materials and methods

Literature search.

This systematic review was conducted following the PRISMA protocol (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) 6 . Potentially relevant literature was retrieved from PubMed/MEDLINE, Embase, and the Cochrane Library. The final search was conducted on the 20th of September 2023. Detailed search strategy is reported in Supplementary Material 1. Word variations and exploded medical subject headings were searched for whenever feasible.

Inclusion and exclusion criteria

Comparative studies in English language that met the following PICO (Patient, Intervention, Comparison, Outcome) criteria were considered eligible. Patients: individuals with symptomatic hydrocephalus. Intervention: VAS. Comparison: VPS. Outcomes: surgical revision, shunt dysfunction, infection, mortality.

No chronological limits of study publications were adopted. Prospective and retrospective clinical studies, and reports of case series with at least five patients per group and reporting data on comparison between VAS and VPS techniques and reporting at least one outcome of interest were eligible for inclusion. Meta-analyses, case reports, or studies with less than 5 patients per group, cadaver studies, laboratory and animal studies were excluded. Studies including only one surgical method or other possible shunting techniques such as ventriculo-ureteral, ventriculo-gallbladder, ventriculo-pleural cavity or ventriculo-subgaleal shunt, were not included.

Screening and full-text review

Title and abstract screening, full-text review, and data extraction were undertaken in parallel by two reviewers (F.L. and L.B.). Disagreements at any stage were resolved by discussion and consensus. The main disagreements concerned the absence of clear comparative studies between the VAS and VPS techniques; in this case they were resolved by the involvement of a third reviewer (A.M.). The process was carried out using Rayyan 7 .

Data extraction

Several items were considered in the evaluation of VAS/VPS surgical techniques and were divided in two main categories: patient demographics and surgery characteristics. In the first group sex, mean age at first placement of the CSF shunt system, and the etiology of the hydrocephalus were investigated. In the second group data on primary surgical choice, VAS/VPS short- and long-term complications, resolution of the hydrocephalus, number of revisions, and the mean time at first revision of the CSF diversion system were collected. The following data were extracted: author name, publication year, the country of studies, study design, sample size, age, etiology of hydrocephalus, size of surgical groups (VAS/VPS), median follow-up time, and outcome measures that were reported as frequencies during follow-up time.

Risk-of-bias assessment

The Cochrane risk-of-bias tool for nonrandomized studies of interventions (ROBINS-I tool) was used for risk-of-bias assessment of the included studies 8 . This was performed by two authors (J. B., and A. M.).

Statistical analysis

The statistical analysis was carried out with the statistical program R studio (Posit Software, PBC formerly R Studio, version 02.07.2022). The baseline characteristics of the included studies were analyzed using descriptive statistics. The meta-analysis was performed using the package meta (version 6.5-0, published 2023-06-07). A random effect model for the meta-analysis was conducted because of the methodological and clinical differences among the studies. The odds ratio (OR) of frequency data with the corresponding 95% CI were pooled by the inverse-variance test. The I2 test was used to capture the between studies’ heterogeneities, which refers to the proportion of total variation because of the differences among included studies instead of sampling error. All statistical tests were two-tailed, and the significance level was set at P value < 0.05.

As illustrated in the PRISMA flowchart of Fig. 1 , the PubMed/MEDLINE, Embase and Cochrane Library search provided 10,582 articles. After duplicate removal (n = 3153), 7429 records were screened, and 753 were then assessed for eligibility through full-text screening. Finally, 9 studies meeting the inclusion and exclusion criteria and reporting on 3197 patients were identified and included in the quantitative synthesis. Sufficient data was available to perform meta-analysis for surgical revision, shunt dysfunction/obstruction, infection, and mortality.

PRISMA flowchart.

Study characteristics and quality

Table 1 lists the main characteristics of the included studies, including publication year, study design and sample size, etiology of hydrocephalus, size of surgical groups, median follow-up time (in months), mean age at surgery (in years), and the risk of bias evaluated with ROBINS-I tool. These 9 studies yielded 3197 patients with hydrocephalus, of whom 1338 (42%) and 1798 (56%) received VAS and VPS surgery, respectively. Three studies (Olsen and Frykberg, Fernell et al., Keucher and Maeley) investigated pediatric patient cohorts, and three studies (Lam and Villemure, McGovern et al., and Hung et al.) adult patient cohorts. The remaining three studies (Ignelzi and Kirsch, Borgbjerg et al., and Rymarczuk et al.) included a mixed cohort of pediatric and adult patients. Apart from the study of Hung et al., comparing VPS and VAS in a cohort of idiopathic normal pressure hydrocephalus (NPH), all the other studies included patients with different causes of hydrocephalus. All the included studies had a retrospective study design, and they were scored with an overall serious to critical risk of bias according to the Cochrane’s ROBINS-I tool (Table 1 ). In Table 2 the frequencies of the investigated outcome variables (revision surgery, shunt dysfunction/obstruction, infection-related complication, death) in the included studies are summarized. In this context, it is worth to mention that the studies of Ignelzi and Kirsch, Fernell et al., Lam and Villemure, and Borgbjerg et al. did not report the median follow-up time between the two surgical groups. Additionally, the median follow-up time showed a consistent difference in the studies of Keucher and Maeley, shorter in the VPS group, and Hung et al., shorter in the VAS group. In the studies of Fernell et al. and Keucher and Maeley the total amount of surgical revision was reported, thus not allowing to differentiate the number of patients that needed at least one surgical revision. Over the years, a trend towards performing VPS as primary surgical treatment for hydrocephalus was observed. Indeed, in three most recent studies (McGovern et al., Hung et al. and Rymarczuk et al.) VAS was considered and performed as primary shunt treatment option only in case of contraindications for VPS, such as previous abdominal surgery, suspected increased intra-abdominal pressure, history of peritonitis, abdominal trauma, or other abdominal infections that could threaten the shunt sterility or challenge its positioning due to tissue adherence. Conversely, in older studies the decision to perform VPS or VAS relied more on the surgeon’s preference and experience rather than on patient-related factors.

In Fig. 2 the results of the meta-analysis of the pooled study findings for the investigated outcomes are reported by means of forest plots.

Forest plots of the pooled analysis of the investigated outcome variables. VAS indicates vantriculoatrial shunt, VPS ventriculoperitoneal shunt. (++) indicates critical risk of bias, whereas (+) serious risk of bias.

Surgical revision: seven studies reported the frequency of at least one surgical revision 9 , 10 , 11 , 12 , 13 , 14 , 15 . 481 events were observed in the VAS group (n = 1111) and 660 in the VPS group (n = 1584). The risk for revision was not significantly different between the two groups; nonetheless, the heterogeneity between the studies was high [odds ratio (OR) 0.73, 95%-CI 0.36–1.49, I 2 91%].

Only one pediatric study provided data on surgical revision, indicating a significantly lower risk in the VAS group (OR 0.20, 95%-CI 0.09–0.44) 10 . Among adult studies all three reported on surgical revision. However, the risk did not significantly differ between VPS and VAS groups (OR 0.95, 95%-CI 0.21–4.26, I 2 = 91%) 11 , 13 , 14 .

Shunt dysfunction/obstruction: five studies reported the frequency of at least one shunt dysfunction/obstruction 9 , 10 , 11 , 13 , 14 . 165 events were observed in the VAS group (n = 509) and 211 in the VPS group (n = 759). The risk for shunt dysfunction/obstruction was significantly lower in the VAS group (OR 0.49, 95%-CI 0.34–0.70, I 2 0%). Only one pediatric study provided data on shunt dysfunction/obstruction, showing a significantly lower risk in the VAS group (OR 0.33, 95%-CI 0.15–0.75) 10 . Among adult patients all three studies reported on shunt dysfunction/obstruction 11 , 13 , 14 . The risk was significantly lower in the VAS group (OR 0.42, 95%-CI 0.25–0.70, I 2 = 0%).

Infection: five studies reported the frequency of at least one infection 9 , 10 , 13 , 14 , 15 . 44 events were observed in the VAS (n = 545) and 54 in the VPS group (n = 1145). The risk for infection was not significantly different between the two groups (OR 1.02, 95%-CI 0.59–1.74, I 2 0%).

Only one pediatric study reported infection data, showing no significant difference in risk between the VPS and VAS groups (OR 1.43, 95%-CI 0.71–2.87) 10 . Among adult patients only two studies reported infection information 13 , 14 . The risk did not significantly differ between the VPS and VAS groups (OR 0.50, 95%-CI 0.13–1.95, I 2 = 0%).

Mortality: three studies reported the frequency of death 10 , 16 , 17 . 8 events were observed in the VAS group (n = 330) and 22 in the VPS group (n = 283), The risk of death was not significantly different between the two groups; nonetheless, the heterogeneity between the studies was high (OR 1.93, 95%-CI 0.81–4.62, I 2 64%). Three pediatric studies provided mortality data, showing no significant difference in risk between the VPS and VAS groups (OR 1.93, 95%-CI 0.81–4.62, I 2 = 64%) 10 , 16 , 17 . No studies focusing on adult patients reported mortality information.

Publication Bias

Funnel plots of the investigated outcomes can be found in the Supplementary Content 2 – Funnel Plots.

Firstly described in historical medical works by Galen and Hippocrates 18 , hydrocephalus is a common disorder of CSF physiology resulting in abnormal expansion of the cerebral ventricles, affecting an estimated number of 85 per 100,000 individuals in the general population ranging from children to the elderly 19 . The first CSF diversion system was proposed by Mikulicz in the 1893 with a permanent ventriculo-subarachnoid-subgaleal shunt, representing simultaneously a ventriculostomy and a drainage into an extrathecal low pressure compartment 18 . Since then, several attempts were made to find a practical and reliable solution for the drainage of the exceeded CSF. In 1946 the first silicone implant for human usage was introduced, but only ten years later in 1956 it was firstly utilized for the development of a CSF shunt by Holter and Pudenz 20 . Almost in the same time period, the creation of a valve system capable of adjustment of the opening-pressure and consequently preventing CSF reflux in the brain started a new era of surgical treatments for hydrocephalus, leading to the development of the VAS in the 1960s 1 and of the VPS in the 1970s 2 .

In 1970s and 1980s, different studies by Little et al., Olsen and Frykberg, and Keucher and Mealey reported the inferiority of VAS compared to VPS in pediatric population. It was reported that VAS had a higher mortality and required more lengthening revisions because of child’s growth, although the infection and dysfunction rate was similar between the two techniques 10 , 21 , 22 . After these studies, there was a gradual switching from VAS to VPS, even though few works comparing the two techniques in the adult population were reported. In 2014 McGovernor et al. compared the safety of VAS and VPS in adult and elderly patients with idiopathic NPH, highlighting the absence of the risk of surgical revisions to lengthen the distal shunt in the adult population 13 . Additionally, the frequent use of anticoagulant or antiplatelet therapies in the elderly contributed to lower the risk of distal thrombi and/or cardiopulmonary complications. In conclusion, the authors suggested that VAS was as safe as VPS in the surgical treatment of idiopathic NPH 13 . In addition, compared to the 1970s and 1980s studies, there was a relevant improvement in infection control and intraoperative imaging enabling a safer catheter placement in the right atrium. Despite this, in recent decades, VAS has generally been considered as a last resort surgical option in both adult and pediatric population. Currently, VPS represents the first treatment option in almost all patient with hydrocephalus, even in challenging cases of history of abdominal surgery or increased abdominal pressure due to obesity 23 , 24 . In addition, during the last years the new generation of neurosurgeons has become more familiar and confident with VPS technique, thus explaining the underutilization of VAS. Aside from these statements, the final technical choice relies eventually on surgeon’s preference and expertise.

In this context, this study aims to evaluate the complication profile of VAS e VPS, including studies that reported comparative data between the two techniques. Through a comprehensive systematic review and meta-analysis of the available literature until September 2023, surgical revisions, shunt dysfunction/obstruction, infection, and mortality were assessed among 3197 patients, with a heterogeneous etiology and age-population of hydrocephalus (Table 1 ).

The literature does not provide high evidence regarding which type of shunt requires fewer revisions. Puca et al. reported revision rates of 28% for VPS and 27% for VAS 25 . According to Hung et al., the probability of shunt obstruction and shunt revision was lower in patients with VAS than in patients with VPS 14 . In this study, there were no statistical differences regarding the need of at least one surgical revision of the shunt system (OR 0.91; 95% CI 0.76–1.09). Additionally, it was observed a lower risk of shunt dysfunction/obstruction variable in the VAS group (OR 0.50; 95% CI 0.36–0.69). Furthermore, it has not been identified statistical difference on the occurrence of at least one infection-related complication (OR 1.03; 95% CI 0.62–1.73) between the VPS and VAS groups. These results confirm data reported in studies available from the literature: L.B. Oliveira et al. reported an infection rate of 5% (95% CI: 3–7%) 3 ; Merkler et al. reported an infection rate of 6.1% (95% CI: 5.7–6.5%) for VPS 26 . On the other hand, there was a higher mortality in the VAS group (OR 1.96; 95% CI 1.16–3.31), even though this result comes from the analysis of three non-recent studies, from the years 1979, 1983 and 1985 10 , 16 , 17 .

A recent meta-analysis on VAS complication, including 52 studies and involving 2862 patients, showed an estimated risk of 0% for glomerulonephritis, intracranial hemorrhage, hygroma, cardiac complications, pulmonary complications, and shunt-related mortality 3 .

Performing a literature review limited to the last 10 years from PubMed/MEDLINE and Embase regarding patients treated with VAS as primary treatment, it was observed that the main reasons for this surgical choice were previous abdominal surgery, abdominal infections, and obesity. Considering that abdominal surgeries are more common in adult patients, and the very high incidence of obesity, it is appropriate to evaluate the possibility of VAS in the treatment of hydrocephalus for this patient profile.

VAS is a safe surgical option for hydrocephalus. In this study, it was observed a lower risk of shunt dysfunction/obstruction in the VAS group, and there were no statistical differences regarding the occurrence of at least one infection-related complication. This data could change with improvements of the technique, overall quality, and availability of diagnostic equipment and interventional radiologists. Our findings suggest that VAS is a safe alternative when VPS is not feasible. Nonetheless, further randomized studies are required to establish the real benefit of one type of shunt over the other.

Limitations

Some important limitations should be considered. First, as mentioned above, in some of the included studies the follow-up time differed significantly among the two surgical groups of patients that underwent VAS and VPS treatment; in this context the variability of the outcome rates is difficult to compare. Second, the analysis included a heterogeneous population with both adults and pediatric patients. Lastly, in recent years VAS has been often considered as second treatment option due to technical preferences and biases of neurosurgeons. This is reflected in the studies included in this work, representing an uncontrollable source of confounders, and therefore limiting the comparative analysis.

VAS continues to be a valuable surgical option. The results of this study suggest that VAS is a safe surgical option. Although there is a high heterogeneity between the examined studies, the risk for shunt dysfuction/obstruction is significantly lower in the VAS group and on the other hand, the risk of infection, revision and death were not significantly different between the two groups. The choice between these two techniques must be tailored to the specific characteristics of the patient. In particular, VAS may be a valuable option in cases of previous abdominal surgery, abdominal infections and obesity. The new generations of neurosurgeons are encouraged to learn both the surgical procedures in order the best option for every patient. Given the limitations outlined above, it is crucial to interpret the results with caution. Encouraging future research with randomized clinical trials is essential to overcome these limitations and improve our understanding of the indications and complications of VAS. In particular, we suggest conducting trials with similar patient profiles, analyzing the differences in the surgery time duration between the two techniques, and having follow-up data as long-term as possible.

Data and code availability

Data or information needed to re-produce the findings presented are available from the corresponding author upon reasonable request.

Abbreviations

Cerebrospinal fluid

Ventriculoperitoneal Shunt

Ventriculoatrial shunt

Normal-pressure hydrocephalus

Confidence interval

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Neurosurgery Unit, Department of Neuroscience “Rita Levi Montalcini”, AOU Città della Salute e della Scienza di Torino, University Hospital, University of Turin, 10124, Turin, Italy

Enrico Lo Bue, Alberto Morello, Leonardo Bradaschia, Filippo Lacatena, Stefano Colonna, Alessandro Fiumefreddo, Diego Garbossa & Fabio Cofano

Department of Neurosurgery, University Hospital Zurich, Zurich, Switzerland

Jacopo Bellomo, Lennart Stieglitz & Luca Regli

Clinical Neuroscience Center, University of Zurich and Swiss Federal Institute of Technology Zurich, Zurich, Switzerland

Stereotactic and Functional Neurosurgery Unit, Department of Neuroscience “Rita Levi Montalcini”, AOU Città della Salute e della Scienza di Torino, University Hospital, University of Turin, Turin, Italy

Michele Maria Lanotte

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Study concept: E.L.B., A.M. Study design: A.M. Data acquisition: L.B., F.L., S.C. Quality control of data and algorithms: JB, AM. Data analysis and interpretation: J.B., A.M. Statistical analysis: J.B., A.M. Manuscript preparation: E.L.B., A.M., A.F. Manuscript editing: E.L.B., L.R., M.M.L.; D.G. Manuscript review: L.S., D.G., F.C. All authors agreed to the publication of this work.

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Bue, E.L., Morello, A., Bellomo, J. et al. Ventriculoatrial shunt remains a safe surgical alternative for hydrocephalus: a systematic review and meta-analysis. Sci Rep 14 , 18460 (2024). https://doi.org/10.1038/s41598-024-62366-8

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Garneau WM , Jones-Beatty K , Ufua MO, et al. Analysis of Clinical Outcomes of Pregnant Patients Treated With Nirmatrelvir and Ritonavir for Acute SARS-CoV-2 Infection. JAMA Netw Open. 2022;5(11):e2244141. doi:10.1001/jamanetworkopen.2022.44141

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Analysis of Clinical Outcomes of Pregnant Patients Treated With Nirmatrelvir and Ritonavir for Acute SARS-CoV-2 Infection

1 Division of Hospital Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland
2 Integrated Research Center for Fetal Medicine, Department of Gynecology and Obstetrics, Johns Hopkins University School of Medicine, Baltimore, Maryland
3 Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, Maryland
4 Department of Molecular Microbiology and Immunology, Johns Hopkins University School of Medicine, Baltimore, Maryland
5 Division of Infectious Diseases, Johns Hopkins University School of Medicine, Baltimore, Maryland

Question What outcomes are associated with nirmatrelvir and ritonavir for treatment of SARS-CoV-2 infection in pregnant patients?

Findings In this case series of 47 pregnant patients who were treated with nirmatrelvir and ritonavir, the medication was well tolerated without evidence of an increase in complications affecting birthing parents or their offspring. Approximately half of deliveries after treatment with nirmatrelvir and ritonavir were via cesarean delivery.

Meaning Results of this study suggest that pregnant patients with SARS-CoV-2 infection can be safely treated with nirmatrelvir and ritonavir.

Importance Pregnant people are at increased risk of poor outcomes due to infection with SARS-CoV-2, and there are limited therapeutic options available.

Objective To evaluate the clinical outcomes associated with nirmatrelvir and ritonavir used to treat SARS-CoV-2 infection in pregnant patients.

Design, Setting, and Participants This case series included pregnant patients who were diagnosed with SARS-CoV-2 infection, received nirmatrelvir and ritonavir, and delivered their offspring within the Johns Hopkins Health System between December 22, 2021, and August 20, 2022.

Exposures Treatment with nirmatrelvir and ritonavir for SARS-CoV-2 infection during pregnancy.

Main Outcomes and Measures Clinical characteristics and outcomes were ascertained through manual record review.

Results Forty-seven pregnant patients (median [range] age, 34 [22-43] years) were included in the study, and the median (range) gestational age of their offspring was 28.4 (4.3-39.6) weeks. Medication was initiated at a median (range) of 1 (0-5) day after symptom onset, and only 2 patients [4.3%] did not complete the course of therapy because of adverse effects. Thirty patients (63.8%) treated with nirmatrelvir and ritonavir had a comorbidity in addition to pregnancy that could be a risk factor for developing severe COVID-19. Twenty-five patients [53.2%] delivered after treatment with nirmatrelvir and ritonavir. Twelve of these patients [48.0%] underwent cesarean delivery, 9 [75.0%] of which were scheduled. Two of 47 patients [4.3%] were hospitalized for conditions related to preexisting comorbidities.

Conclusions and Relevance In this case series, pregnant patients who were treated with nirmatrelvir and ritonavir tolerated treatment well, although there was an unexpectedly high rate of cesarean deliveries. The lack of an increase in serious adverse effects affecting pregnant patients or offspring suggests that clinicians can use this drug combination to treat pregnant patients with SARS-CoV-2 infection.

COVID-19 is associated with considerable morbidity and mortality, particularly among pregnant patients, which can affect the health of the developing fetus. 1 Pregnant patients infected with SARS-CoV-2 have higher rates of severe COVID-19, enhanced immune response, higher preterm birth rates, and increased abnormal maternal vessels and thrombi in placental tissue compared with those without SARS-CoV-2 infection. 2 - 5 Given the continued community transmission of SARS-CoV-2 despite vaccines being available, infection with SARS-CoV-2 will continue to affect pregnant patients, and treatment decisions pose challenges for maternal and fetal health clinicians.

The nirmatrelvir and ritonavir drug combination was granted an emergency use authorization by the US Food and Drug Administration (FDA) on December 22, 2021, for the treatment of mild to moderate COVID-19 in patients aged 12 years and older who are at high risk of progression to severe COVID-19. 6 The drug is effective, acting as an inhibitor of the SARS-COV-2 main protease. 7 The FDA states that there is inadequate knowledge of the effects of nirmatrelvir and ritonavir on the birthing parent and fetus to make a statement on its safety in pregnancy. 6 Safety data for nirmatrelvir in rats and rabbits did not show either developmental toxic effects or detrimental effects on fertility. 8 Data from the FDA show no increase in the risk of birth defects in pregnant individuals taking ritonavir. 9

Nirmatrelvir and ritonavir showed no significant reduction in hospitalization and deaths in a subgroup analysis of patients with at least 1 risk factor for developing severe COVID-19. 10 While there has been widespread adoption of nirmatrelvir and ritonavir as an oral option for outpatient treatment of SARS-CoV-2 infection, use of this drug combination in pregnancy is not well studied and may not be adequately used by patients and their clinicians due to lack of data in pregnant patients.

More than 130 000 new SARS-CoV-2 infections were reported daily in the United States as of August 2022. 11 The safety of vaccination against SARS-CoV-2 for pregnant individuals has been reported previously; rates of vaccine uptake among pregnant people, however, is lower than expected, and vaccinated individuals remain at risk of SARS-COV-2 infection, particularly with variants of concern, despite vaccination. 12 - 15 There are multiple effective therapies for outpatient treatment of acute SARS-CoV-2, including remdesivir, convalescent plasma, molnupiravir, and monoclonal antibodies. Yet each of these options has limitations. Remdesivir, monoclonal antibodies, and convalescent plasma must be administered intravenously. Molnupiravir is an oral treatment for COVID-19 treatment; its mechanism of action, however, introduces errors into RNA replication, and it is contraindicated in pregnancy due to harm to the developing fetus. 16 The aim of the study was to evaluate outcomes in pregnant patients who were treated with nirmatrelvir and ritonavir within a large hospital system to assess the outcomes associated with this drug combination to treat SARS-CoV-2 infection in this patient population.

This case series used the COVID-19 Precision Medicine Analytics Platform Registry (JH-CROWN), a database that includes outpatient and inpatient records for patients with SARS-CoV-2 within the Johns Hopkins Health System. The health system is located in Maryland and Washington, DC, and includes 6 hospitals and more than 40 outpatient facilities. The research was approved by the Core for Clinical Research Data Acquisition, which administers the JH-CROWN registry, and the Johns Hopkins Institutional Review Board, which waived the requirement for informed consent because only deidentified data were used. We followed the reporting guideline for case series in medicine.

Pregnant patients with a positive SARS-COV-2 test result within the Johns Hopkins Health System after FDA emergency use approval of nirmatrelvir and ritonavir from December 22, 2021, to August 20, 2022, were eligible for study inclusion. A query was written to identify patients with a diagnosis of pregnancy, a positive test result for SARS-CoV-2 between these dates, and a prescription for nirmatrelvir and ritonavir. Manual medical record review was performed on all medical records of patients who met these 3 criteria. Records were excluded if the patient was not pregnant, if there was no documentation of receipt of nirmatrelvir and ritonavir, or if records were duplicates. The medical records were reviewed at the time of the prescription, and subsequent notes were reviewed to assess patient outcomes and tolerance. Individual characteristics, including maternal age, gestational age, practitioner type, prepregnancy body mass index (BMI, calculated as weight in kilograms divided by height in meters squared), gravidity and parity, vaccination status, prepregnancy comorbidities, adverse effects after administration of nirmatrelvir and ritonavir, delivery date, and delivery complications, were collected using REDCap, version 12.0.16 (Vanderbilt University). 17 , 18 Race and ethnicity were classified by self-report in the electronic medical record and were collected to characterize the differences in socioeconomic factors associated with access to care. Age was defined as the age when the patient was treated with nirmatrelvir and ritonavir. Vaccination status was defined as having had no vaccination, having received the initial vaccination series, or having received the initial vaccination series with 1 or 2 additional boosters. Comorbidities were collected from the Epic Systems electronic health record problem list on initiation of antenatal care. We reviewed the medical record for specific comorbidities based on the Centers for Disease Control and Prevention (CDC) and Infectious Diseases Society of America (IDSA) indications for outpatient treatment with nirmatrelvir and ritonavir including patient age 65 years or older, chronic kidney disease, diabetes, BMI of 25 or greater, chronic lung disease, sickle cell disease, cardiovascular disease or hypertension, use of immunosuppressing medications, neurodevelopmental disorders, and medical technological dependence. 19

Forty-seven patients (median [range] age, 34 [22-43] years) were pregnant at the time they received nirmatrelvir and ritonavir from December 22, 2021, to August 20, 2022 ( Figure ), and the median (range) gestational age of their offspring was 28.4 (4.3-39.6) weeks. The median (range) time from symptom onset to receipt of medication was 1 (0-5) day. The baseline characteristics of pregnant patients receiving nirmatrelvir and ritonavir are presented in Table 1 .

Twenty-seven patients (57.4%) received nirmatrelvir and ritonavir in the third trimester of pregnancy, 16 (34.0%) in the second trimester, and 4 (8.5%) in the first trimester. Forty patients (85.1%) had received some vaccination: 16 (34.0%) had received the initial vaccination series, 21 (44.7%) had received the initial vaccination series and 1 booster, and 3 (6.4%) had received the initial vaccination series and 2 boosters. Forty-three patients (91.5%) had any comorbidity, with mental health disorder (21 [44.7%]) being the most commonly reported. Thirty patients (63.8%) had a comorbidity other than pregnancy that qualified as a CDC and IDSA indication for outpatient treatment with nirmatrelvir and ritonavir, with the most common indication being a BMI of 25 or greater (24 [51.1%]).

All patients were either treated for COVID-19 as outpatients or were treated while hospitalized for reasons other than COVID-19. Thirty-seven prescriptions (78.7%) were written by obstetricians and gynecologists, and 10 (21.3%) were written by midlevel practitioners ( Table 2 ). Twelve prescriptions (25.5%) were filled in May 2022, 17 (36.2%) in June 2022, 12 (25.5%) in July 2022, and 6 (12.8%) in August 2022. Viral sequencing data were available for 5 patients (10.6%) whose testing was performed within the Johns Hopkins Health System. Four of the samples (80.0%) were identified as Omicron (BA.4, BA.2, BA.5, unassigned) and 1 (20%) as Delta (21I).

Two patients (4.3%) were hospitalized during pregnancy after treatment with nirmatrelvir and ritonavir: 1 for vomiting and dehydration in the setting of preexisting hyperemesis gravidarum and 1 for persistent cough in the context of sickle cell crisis; this patient was identified as having placenta accreta and experienced postpartum hemorrhage. Two patients (4.3%) discontinued the medication before completing treatment due to adverse effects. Three patients (6.4%) developed gestational hypertension. One patient (2.1%) developed excessive fetal growth and polyhydramnios. One patient (2.1%) developed oligohydramnios. One patient (2.1%) with a history of bicornuate uterus and multiple children with genetic disorders experienced the loss of a twin pregnancy at 12 weeks. A fetus that was the product of the pregnant patient’s in-vitro fertilization at age 40 years was noted to have absent ductus venosus as well as thickened nuchal fold. One fetus developed intrauterine growth restriction and syndactyly and was noted to have cystic hygroma before nirmatrelvir and ritonavir exposure. Twenty-five patients (53.2%) delivered after treatment with nirmatrelvir and ritonavir. Patient outcomes are summarized in Table 2 .

Twelve of the 25 patients (48.0%) who delivered after treatment underwent cesarean delivery; 9 of these (75.0%) were scheduled. One unplanned cesarean delivery was performed during the birth of twins in which arrest of labor occurred after the first vaginal birth, 1 was in the context of fetal intolerance of labor, and 1 was in the context of oligohydramnios and breech presentation. Delivery outcomes are summarized in Table 3 .

This study has several important findings. First, the nirmatrelvir and ritonavir combination was well tolerated and did not pose an immediate threat to the birthing parent or fetus in this study. In addition, 63.8% of pregnant patients who received nirmatrelvir and ritonavir were prescribed the drug combination for an indication other than pregnancy, and 78.7% of prescriptions were written by obstetricians and gynecologists. Most patients who received nirmatrelvir and ritonavir were vaccinated, and relatively few Black patients were included in the cohort, suggesting that disparities in vaccine uptake may also be reflected in the use of nirmatrelvir and ritonavir as a therapy in pregnancy.

Only 2 patients discontinued nirmatrelvir and ritonavir due to adverse effects, and no complications were associated with the drug. This finding was replicated in another descriptive study from the University of Connecticut of 7 pregnant patients treated with nirmatrelvir and ritonavir who all experienced symptomatic improvement and no adverse pregnancy outcomes. 20 In accordance with our findings, 85.7% of patients in that study were vaccinated before nirmatrelvir and ritonavir use; racial demographic characteristics were not reported. In contrast to our findings, the 3 deliveries in that study were vaginal births. The present study had a relatively high rate of cesarean deliveries in patients who received nirmatrelvir and ritonavir and delivered.

The CDC and IDSA outpatient treatment guidelines include pregnant patients among populations at higher risk for developing severe COVID-19 and who are eligible to use nirmatrelvir and ritonavir. 19 , 21 This recommendation is supported by the Society for Maternal-Fetal Medicine. 22 In the present study, prescriptions for pregnant patients did not begin until May 2022 and increased in June 2022. Seventy-nine percent of prescriptions were from obstetricians, which likely reflects the diverse roles of obstetricians and gynecologists in treating their pregnant patients. In the present study, we found no serious adverse effects associated with nirmatrelvir and ritonavir in pregnant patients. Because COVID-19 will continue to present in a variety of settings, it is important for other health care practitioners to use this drug combination in this high-risk population.

Although Johns Hopkins Health System cares for a diverse patient population, the patients in this study were of advanced age, and few were of racial or ethnic minority groups. It was unclear if all pregnant patients with SARS-CoV-2 were offered treatment or if rates of refusal differed by age group. Future studies will need to be conducted to evaluate disparities in receipt of treatment.

There are several limitations to this study, including the use of data from a single health system and a small population studied with mild illness. However, to our knowledge, this is the largest study to date in this population and found no serious adverse effects to the patients or their fetuses. The rise of at-home COVID-19 testing and use of registries designed for hospitalized patients means some patients were not included due to unrecorded testing and lack of standardized outpatient evaluation tools. Another limitation was the short follow-up period. Only 25 of 47 patients had undergone delivery at the time of this report. Treatment effects may not be apparent at delivery, and long-term effects of treatment will need to be followed up in both the birthing parents and children.

Findings of this case series support the safety and effectiveness of nirmatrelvir and ritonavir in pregnant patients with acute SARS-CoV-2. Although there are multiple effective therapies for outpatient treatment of acute SARS-CoV-2, all are either intravenous (remdesivir, convalescent plasma, and monoclonal antibodies) or contraindicated in pregnancy (molnupiravir). Nirmatrelvir and ritonavir can be easily used as a first-line outpatient treatment for pregnant patients. Future larger studies will be needed to evaluate for rare complications in neonates or birthing parents who are treated with this medication. The serious risk of morbidity from SARS-CoV-2 among pregnant patients is further justification for practitioners to encourage vaccination and use of nirmatrelvir and ritonavir to minimize the risk to pregnant patients and their fetuses.

Accepted for Publication: October 14, 2022.

Published: November 29, 2022. doi:10.1001/jamanetworkopen.2022.44141

Corresponding Authors: Kelly A. Gebo, MD, MPH, Division of Infectious Diseases, Johns Hopkins University School of Medicine, 1830 E Monument St, Rm 435, Baltimore, MD 21205 ( [email protected] ); Irina Burd, MD, PhD, Integrated Research Center for Fetal Medicine, Department of Gynecology and Obstetrics, Johns Hopkins University School of Medicine, 600 N Wolfe St, Phipps 217, Baltimore, MD 21287 ( [email protected] ).

Author Contributions: Dr Burd had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Drs Burd and Gebo contributed equally.

Concept and design: Garneau, Klein, Burd, Gebo.

Acquisition, analysis, or interpretation of data: All authors.

Drafting of the manuscript: Garneau, Burd.

Critical revision of the manuscript for important intellectual content: Garneau, Jones-Beatty, Ufua, Mostafa, Klein, Gebo.

Statistical analysis: Garneau.

Obtained funding: Klein, Gebo.

Administrative, technical, or material support: Garneau, Jones-Beatty, Mostafa, Klein, Gebo.

Supervision: Klein, Burd, Gebo.

Conflict of Interest Disclosures: Dr Garneau reported receiving honorarium from DKBmed; serving as a scientific advisor to Gilead Sciences, Inc; and owning stock in Abbott, Avantor, Danaher, Eli Lilly and Company, Ecolab, Iqvia, Johnson & Johnson, Stryker, UnitedHealthcare, and AstraZeneca. Dr Mostafa reported receiving grants from the Centers for Disease Control and Prevention, Maryland Department of Health, Johns Hopkins University, and National Institutes of Health during the conduct of the study and receiving grants from Bio-Rad, DiaSorin, and Hologic, honoraria from Roche, and personal fees from SeeGene for serving on an advisory board outside the submitted work. Dr Gebo reported serving as a consultant for UpToDate, Teach for America, and the Aspen Institute outside the submitted work. No other disclosures were reported.

Funding/Support: This study was made possible by the Johns Hopkins Institute for Clinical and Translational Research, which is funded in part by the National Center for Advancing Translational Sciences (grant UL1 TR003098), a component of the National Institutes of Health, and National Institutes of Health Roadmap for Medical Research.

Role of the Funder/Sponsor: The funders had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

Disclaimer: This article’s contents are solely the responsibility of the authors and do not necessarily represent the official view of the Johns Hopkins Institute for Clinical and Translational Research, National Center for Advancing Translational Sciences, or National Institutes of Health.

Additional Information: The data used for this study were provided by the Johns Hopkins COVID-19 Precision Medicine Center of Excellence, officially designated by the Precision Medicine Analytics Platform leadership, and based on the contribution of many patients and clinicians.

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A case-control study of surgical site infection following operative fixation of fractures of the ankle in a large U.K. trauma unit

Affiliation.

1 University Hospitals of Leicester, Gwendolen Road, Leicester LE5 4PW, UK.
PMID: 24788498
DOI: 10.1302/0301-620X.96B5.33143

Most of the literature on surgical site infections following the surgical treatment of fractures of the ankle is based on small series of patients, focusing on diabetics or the elderly. None have described post-operative functional scores in those patients who develop an infection. We performed an age- and gender-matched case-control study to identify patient- and surgery-related risk factors for surgical site infection following open reduction and internal fixation of a fracture of the ankle. Logistic regression analysis was used to identify significant risk factors for infection and to calculate odds ratios (OR). Function was assessed using the Olerud and Molander Ankle Score. The incidence of infection was 4% (29/717) and 1.1% (8/717) were deep infections. The median ankle score was significantly lower in the infection group compared with the control group (60 vs 90, Mann-Whitney test p < 0.0001). Multivariate regression analysis showed that diabetes (OR = 15, p = 0.031), nursing home residence (OR = 12, p = 0.018) and Weber C fractures (OR = 4, p = 0.048) were significant risk factors for infection. A low incidence of infection following open reduction and internal fixation of fractures of the ankle was observed. Both superficial and deep infections result in lower functional scores.

Keywords: Ankle fracture; Case control; Infection; OMAS scores; Osteosynthesis; Risk factors.

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Int J Health Sci (Qassim)
v.6(1); 2012 Jan

Surgical site infections: A one year prospective study in a tertiary care center

Dr. varsha shahane.

* Dept. of Microbiology, Padmashree Dr DY Patil Medical College, Hospital and Research Center, Near Sant Tukaram nagar, Pimpri, Pune. Cell no- 0567076587. moc.liamg@9ahsravelel

Dr. Saikat Bhawal

** Dept. of Microbiology, Padmashree Dr DY Patil Medical College, Hospital and Research Center, Near Sant Tukaram nagar, Pimpri, Pune. [email protected]

Mr. Upendra Lele

** Dept. of Statistics, International School of Business and Media, Nande, Pune. moc.liamtoh@elelu

Surgical Site Infections (SSI) is the third most commonly reported nosocomial infection which has an adverse impact on the hospital as well as on the patient. A continuous surveillance is called for, to keep a check on the occurrence of SSI.

to study the incidence of SSI in our hospital.
to study the risk factors of SSI in our hospital.
to identify the areas in our hospital, which need to be strengthened and dealt with proactive measures to curb the incidence of SSI, which is an indicator of health care system in a given set up.

Methodology

We conducted a one year study of SSI in our hospital. 300 cases of Surgery and Obstetrics and Gynaecology were included in the study. A few host factors, wound factors and surgery related factors that cause SSI were studied. Swabs were collected from the infected surgical wounds and processed by the conventional microbiological methods. Antimicrobial susceptibility was done by Kirby-Bauer disc diffusion method.

Prolonged surgery (>2hours) and insertion of drain were found to be significantly associated with occurrence of SSI and the clean surgeries showed minimum risk of infection. Escherichia coli (31.25%) was the commonest pathogen, followed by Pseudomonas aeruginosa (25 %) and Staphylococcus aureus 22%. The incidence of SSI in our set up is 6%.

Conclusions

The outcome of the SSI surveillance in our hospital revealed that in order to decrease the incidence of SSI we would have to: a) decrease the duration of the surgeries performed b) focus on regular and intensive drain care c) identify poor risk patients and ensure their proper management d) conduct periodic surveillance to keep a check on SSI.

Introduction

Surgical site infections (SSI) are the third most commonly reported nosocomial infection and they account for approximately a quarter of all nosocomial infections. It has an adverse impact on the hospital as well as on the patient. It is responsible for increasing length of stay of patient which results in social and economic loss to the patients and family. Host factors, wound factors and surgery related factors are implicated in the causation of SSI. ( 1 )

The present study was aimed at obtaining the incidence of SSI in our set up and to evaluate the risk factors as well as to formulate an antibiotic policy for patients posted for any surgery in our hospital.

SSI is the index of the health care system of any hospital. With the increase in incidence of nosocomial infections and multi drug resistance, a meticulous and periodic surveillance of various hospital acquired infections is called for.

With an active Infection Control team operating in the hospital, SSI is naturally one of the topmost priorities on the agenda. Hence the following study was undertaken.

Materials and Methods

The present study was conducted in the Dept. of Microbiology, Padm. Dr D Y Patil Medical College, Pune. 300 operated cases in Surgery and Obstetrics and Gynaecology were included in this study. Certain risk factors like – type of surgical wound, elective or emergency surgery, antibiotic prophylaxis, duration of surgery, presence or absence of drain and any underlying or predisposing conditions were noted. Swabs were obtained from the post operative infected wounds and processed by the conventional microbiological methods. ( 2 ) Antimicrobial susceptibility testing was done by Kirby-Bauer disc diffusion method ( 3 ) and interpretation was done according to CLSI guidelines. ( 4 )

CDC criteria were used to define the type of surgical wound i.e. Class I- Clean, Class II- Clean contaminated, Class III- Contaminated, Class IV- Dirty. ( 5 ) The statistical significance of the relative importance of various parameters affecting SSI has been tested using ‘p’ test at 95% confidence level (p< 0.05).

300 surgical wounds (from General Surgery wards and Obstetrics and Gynaecology wards) were studied over a period of one year.

The overall infection rate was 6%.

The incidence of SSI in our set up was 6%. ( Fig 1 ) This is in agreement with the SSI incidences in other studies. ( 6 , 7 ) However, infection rates varying from 20% to as high as 76.9% have also been reported. ( 8 – 12 )

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Incidence of SSI at DYPMC and Hospital

Prolonged duration of operation results in increased exposure of operation site to air, prolonged trauma, stress of prolonged anaesthesia and sometimes blood loss. ( 13 ) Our study reveals a clear cut increased number of SSI cases i.e.13.1% cases, where surgery has been prolonged ≥ 2 hours. ( Fig 2 ). Studies conducted on SSI in Aurangabad, ( 6 ) Mumbai, ( 7 ) Hyderabad, ( 9 ) and Orissa ( 10 ) have reported a similar observation. In fact, this correlation has been established since 1964 by the Public health laboratory services (PHLS) in England and Wales. ( 13 )

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Duration of Surgery of SSI cases

The use of drains has contributed significantly as a risk factor in causing SSI in this study i.e. 13.6% ( Fig 3 ). This could be due to the fact that they are more likely to be used in contaminated or dirty wounds and in emergency and prolonged operations which increases the probability of the wound getting infected. ( 13 ) Mumbai ( 7 ) has also observed 22.4% cases of drained and 3% undrained wounds getting infected while Aligarh ( 8 ) reported 30% and 11.6% respectively.

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Insertion of Drain in SSI cases

The rate of infection was highest in contaminated type of wounds-12.3%, followed by clean contaminated wounds-8.0% and least in clean wounds-4.6% ( Fig 4 ). This is an expected observation. In Aurangabad, ( 6 ) similar rates were noted i.e. percentage of infection rate was 10.6 % and 4% in clean contaminated and clean cases respectively, in Mumbai ( 7 ) 22.4% and 3.0% respectively and in England ( 13 ) 10.8% and 3.0% respectively. However, in Orissa, ( 10 ) the difference between the rate of infection in clean contaminated (25%) and in clean surgeries (30%) was not statistically significant.

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Type of Surgery in SSI cases

Certain underlying conditions like anaemia, diabetes, and smoking may alter or decrease the immune status thus significantly increasing the risk of SSI. They also are an important cause of increasing the pre operative stay of the patient which steeply increases the risk of SSI in such patients. ( 13 ) In our study, 7.6% of patients with SSI had some underlying conditions, anaemia and diabetes mellitus being the commonest ( Fig. 5 ). Each day of extra hospitalization adds to the risk of acquiring SSI and this has been confirmed by studies in Aurangabad, ( 6 ) Mumbai, ( 7 ) Hyderabad ( 9 ) and in Orissa. ( 10 ) In Aligarh ( 8 ) however, it was noted that diabetes mellitus and dehydration did not contribute to the occurrence of SSI.

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Predisposing Condition/s in SSI cases

SSI have occurred more in elective surgeries-7.9%, than in emergency surgeries-2.7% ( Fig 6 ). This observation may seem very surprising, as emergency cases have known to land up in SSI more than the elective ones. ( 10 , 13 – 16 ) However, in our study, there have been more number of elective cases (63%) over the year than emergency cases (37%).

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Category of Surgery in SSI cases

Also, the presence of underlying conditions like anaemia, diabetes mellitus etc was more in patients who had undergone elective surgery (38%) than in those who had emergency operations done (33%). These two factors could have been responsible for this unexpected outcome. In Aurangabad, ( 6 ) the infection rate in emergency surgeries was not statistically higher than in elective surgeries.

Pre operative antibiotics are known to decrease incidence of SSI cases. ( 1 , 6 , 13 ) However, prophylactic antimicrobials are more frequently given to patients who are poor risks from the stand point of susceptibility to infection. ( 13 ) This could explain our finding of a marginal increase of SSI in patients who have received prophylaxis (7.2%) than those who had not (5.6%) ( Fig 7 ).

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Object name is 9f7.jpg

Preoperative Antibiotics in SSI cases

Also, there is a marginal preponderance of male patients developing SSI (7.4%) over female patients with SSI (5.1%) which is not statistically significant ( Fig 8 ). In Aligarh, ( 8 ) females (27%) showed preponderance of SSI than males (18%). However, it has been known that sex is not a pre determinant of the risk of SSI. ( 13 )

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Genderwise SSI

Gram negative bacilli, namely members of enterobacteriaceae, are the predominant pathogens in our setup according to the data provided by the Infection Control Committee of our hospital and our SSI bacteriological profile matched this observation. Of the 18 SSI cases, 4 patients’ swabs yielded no growth (22%) aerobically and anaerobically and showed no organisms on direct smear as well. Mumbai ( 7 ) study has also reported 17.6% culture negative SSI cases. The remaining 14 patients’ swabs yielded a total of 16 isolates in our laboratory of which Escherichia coli was 31.25%, Pseudomonas aeruginosa 25% and Staphylococcus aureus was 22%. This trend of gram negative bacilli i.e. enterobacteriaceae dominating the gram positive cocci has been observed in Aurangabad, ( 6 ) Orissa ( 10 ) and Navi Mumbai ( 11 ) also.

Conversely, in some studies ( 7 , 8 , 9 , 12 ) Staphylococcus aureus has dominated the scene. Multi drug resistance is a dreaded problem in nosocomial infections. Our study reveals enterobacteriaceae showing highest sensitivity to amikacin (78%) followed by gentamicin (71%). In comparison, very low sensitivity is noted with the cephalosporins and fluoroquinolones (10% and 58% respectively). This could be due to the overuse of these drugs and the high prevalence of extended spectrum beta lactamases (ESBLs) among these organisms. Surprisingly, our Pseudomonas isolates showed good sensitivity to piperacilin-tazobactam, ceftazidime and imipenem (83.5%, 83% and 100% respectively).

Staphylococcus aureus showed maximum sensitivity to linezolid (87.3%), gentamicin (100%), clindamycin (100%) vancomycin (100%).

In other studies, penicillins have shown very poor performance while gentamicin has showed maximum sensitivity (> 90%) against both gram positive cocci as well as gram negative bacilli. ( 6 , 7 , 9 , 10 , 12 ) Unlike our study, Hyderabad study ( 9 ) has shown first generation cephalosporins to be very effective for both.

Similar to our observation, vancomycin and linezolid have shown promise for Staphylococcus aureus in Navi Mumbai ( 11 ) too.

To conclude, we have observed that increased duration of surgery (> 2 hours), use of drains, and compromised immunity are responsible for SSI in our set up. Enterobacteriaceae (especially E.coli ) and S.aureus are the predominant pathogens showing maximum sensitivity to amikacin and gentamicin.

We can further bring down our SSI rate by implementing the following measures:

○ Efforts to decrease the duration of surgery without compromising the patient’s safety and the beneficial outcome.
○ Regular and intensive drain care
○ A thorough examination and investigations of poor risk patients should be done and accordingly all appropriate care should be taken to enable them to withstand the stress of surgery. Also utmost post operative care and efforts to boost their immunity would help in decreasing further the occurrence of SSI in this group of patients.
○ Periodic surveillance of SSI will guide the Infection Control Committee in laying down strict guidelines to further decrease the SSI incidence in our setup, which is an indicator of health care in a given system.

Undertaking

I, the undersigned, give an undertaking to the following effect with regard to our article entitled “Surgical Site Infections: A one year prospective study in a tertiary care center ” submitted for publication in International Journal of Health Sciences.

The article mentioned above is original and has not been published or submitted to or accepted for publication in any form, in any other journal and does not infringe any existing copyright or any other third party rights.
We also vouchsafe that the authorship of this article will not be contested by anyone whose name(s) is/are not listed by us here. Conflict of interests is none.
I am authorized by my co-authors to enter into these arrangements.
The article contains nothing that is unlawful, libelous, or which would, if published, constitute a breach of contract or of confidence or of commitment given to secrecy;
Due care to ensure the integrity of the article has been taken.

Dr. Varsha D.Shahane (Corresponding and main author)

IMAGES

(PDF) A Case Study of Reducing Surgical Site Infection (SSI) using a
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CDC definitions of surgical site infection.
(PDF) Patients’ experiences of surgical site infection
(PDF) The impact of surgical site infection on healthcare costs and
(PDF) Guidelines for the prevention of surgical site infection: an

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1. Introduction. Surgical site infections (SSIs) account for over $3 billion in healthcare costs per year, with more than 150,000 new cases occurring annually in the US. 1 A large portion of these costs are attributed to longer hospitalizations, readmissions, and additional surgeries required for the treatment of infected patients. 2 The risk of developing surgical site infections (SSIs ...
Surgical site infections: A one year prospective study in a tertiary
Methodology. We conducted a one year study of SSI in our hospital. 300 cases of Surgery and Obstetrics and Gynaecology were included in the study. A few host factors, wound factors and surgery related factors that cause SSI were studied. Swabs were collected from the infected surgical wounds and processed by the conventional microbiological ...

A case report of a deep surgical site infection with Terrisporobacter glycolicus/T. Mayombei and review of the literature

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Surgical site infections: A one year prospective study in a tertiary care center

Dr. Saikat Bhawal

Mr. Upendra Lele

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