Effectiveness and safety of Ceftolozane/Tazobactam administered in continuous infusion through elastomeric pumps in OPAT regimen: a case series.

PURPOSE: This study aimed to present real-life data on the use, effectiveness, and safety of administering Ceftolozane/Tazobactam (C/T) through elastomeric pumps (EP) in the outpatient setting. METHODS: This case series study was conducted from January 2022 to July 2023 in a large University Hospital in Rome, Italy. Patients receiving continuous infusion of C/T via EP were included up to a follow-up period of 90 days after the end of antibiotic therapy. The primary endpoint was the infection's clinical cure rate. Secondary endpoints were adverse events attributable to continuous home infusion of Ceftolozane/Tazobactam via elastomeric pumps. RESULTS: Seven patients received C/T continuously infused via EP and were included in the final analysis. Three patients suffered from prosthetic joint infection (n = 3/7; 43%), two patients from osteomyelitis (n = 2/7; 29%), one patient from otomastoiditis (n = 1/7; 15%) and one from pneumonia (n = 1/7; 15%). All infection were sustained by P. aeruginosa. Five strains had MDR-type susceptibility profiles (n = 5/7; 71%) and two of these were DTR (n = 2/7; 29%). The infection cure rate reached 86% (n = 6/7). Two patients reported a complication related to the vascular catheter for drug infusion (n = 2/7; 29%). CONCLUSIONS: Continuous infusion of Ceftolozane/Tazobactam by elastomeric pumps has been shown to be safe and effective in practice representing a viable option of intravenous treatment in outpatient setting for infection sustained by P. aeruginosa especially for multidrug-resistant strains.

A systematic review of dalbavancin efficacy as a sequential therapy for infective endocarditis.

INTRODUCTION: Dalbavancin is an antibiotic characterized by an extended half-life and efficacy against methicillin-resistant Staphylococci. Currently, there are only narrative reviews summarizing the evidence about the use of dalbavancin for infective endocarditis (IE), many of which are focused primarily on its use as consolidation therapy. For this reason, we conducted a systematic review to describe the clinical efficacy and the safety of dalbavancin in IE treatment. METHODS: We searched for available evidence using the MEDLINE (PubMed), Embase, Scopus, Cochrane Library and Web of Science libraries, with no restrictions regarding the publication year. The risk of bias was performed using the Cochrane ROBINS-I tool for the comparative studies and the Newcastle-Ottawa Scale for descriptive studies. RESULTS: Nine studies were included. All of them were observational. Native valve endocarditis was the most common kind of IE found in the studies' populations (128/263, 48.7%), followed by prosthetic valve endocarditis, and cardiovascular implantable electronic device-related endocarditis. Coagulase-negative Staphylococci were the most common pathogens isolated (83/269, 30.1%), followed by S. aureus, Enterococci spp and Streptococci spp. Five out of nine studies documented a clinical failure rate of less than 10%. Dalbavancin showed a favourable safety profile. Dalbavancin appears to be a promising option for the consolidation therapy of IE. However, further studies comparing dalbavancin with standard of care are needed. PROSPERO REGISTRATION NUMBER: CRD42023430032.

A GAVeCeLT consensus on the indication, insertion, and management of central venous access devices in the critically ill.

Central venous access devices are essential for the management of critically ill patients, but they are potentially associated with many complications, which may occur during or after insertion. Many evidence-based documents-consensus and guidelines-suggest practical recommendations for reducing catheter-related complications, but they have some limitations. Some documents are not focused on critically ill patients; other documents address only some special strategies, such as the use of ultrasound; other documents are biased by obsolete concepts, inappropriate terminology, and lack of considerations for new technologies and new methods. Thus, the Italian Group of Venous Access Devices (GAVeCeLT) has decided to offer an updated compendium of the main strategies-old and new-that should be adopted for minimizing catheter-related complications in the adult critically ill patient. The project has been planned as a consensus, rather than a guideline, since many issues in this field are relatively recent, and few high-quality randomized clinical studies are currently available, particularly in the area of indications and choice of the device. Panelists were chosen between the Italian vascular access experts who had published papers on peer-reviewed journals about this topic in the last few years. The consensus process was carried out according to the RAND/University of California at Los Angeles (UCLA) Appropriateness Methodology, a modification of the Delphi method, that is, a structured process for collecting knowledge from groups of experts through a series of questionnaires. The final document has been structured as statements which answer to four major sets of questions regarding central venous access in the critically ill: (1) before insertion (seven questions), (2) during insertion (eight questions), (3) after insertion (three questions), and (4) at removal (three questions).

The pediatric DAV-expert algorithm: A GAVeCeLT/GAVePed consensus for the choice of the most appropriate venous access device in children.

In pediatric patients, the choice of the venous access device currently relies upon the operator's experience and preference and on the local availability of specific resources and technologies. Though, considering the limited options for venous access in children if compared to adults, such clinical choice has a great critical relevance and should preferably be based on the best available evidence. Though some algorithms have been published over the last 5 years, none of them seems fully satisfactory and useful in clinical practice. Thus, the GAVePed-which is the pediatric interest group of the most important Italian group on venous access, GAVeCeLT-has developed a national consensus about the choice of the venous access device in children. After a systematic review of the available evidence, the panel of the consensus (which included Italian experts with documented competence in this area) has provided structured recommendations answering 10 key questions regarding the choice of venous access both in emergency and in elective situations, both in the hospitalized and in the non-hospitalized child. Only statements reaching a complete agreement were included in the final recommendations. All recommendations were also structured as a simple visual algorithm, so as to be easily translated into clinical practice.

Outpatient parenteral antibiotic therapy (OPAT) through elastomeric continuous infusion pumps in a real-life observational study: Characteristics, safety, and efficacy analysis.

INTRODUCTION: This study aimed to present real-life data on the use, efficacy, and safety of administering antibiotic therapy through portable elastomeric pumps (pEP) in the outpatient setting. METHODS: This retrospective observational cohort study was conducted from January 2020 to May 2023 in a large academic hospital in Rome, Italy. All patients receiving antibiotic therapy via pEP were included up to a follow-up period of 90 days after the end of antibiotic therapy. The primary outcome was the treatment response. Secondary endpoints were adverse events attributable to the drug administered, the vascular catheter, or the infection itself. RESULTS: Of the 490 patients referred to our outpatient parenteral antibiotic therapy (OPAT) unit, 94 (19.2%) received antibiotic therapy via pEP and were included in the final analysis. The most frequently treated infections were those involving bone and prosthetics, including spondylodiscitis (n=27; 28.8%). Most infections were due to Pseudomonas aeruginosa (n=55; 48.3%). Cefepime (n=32; 34.0%), piperacillin/tazobactam (n=29; 30.9%), ceftolozane/tazobactam (n=7; 7.5%), and oxacillin (n=7; 7.5%) were the most frequently administered antibiotics. The infection cure rate reached 88.3% (n=83). 12 patients (12.8%) reported adverse events, of which half (6.4%) were drug-related and half (6.4%) were line-related. CONCLUSIONS: OPAT through portable elastomeric infusion pumps proved to be safe and effective. It also contributed to the reduction of healthcare costs, fully respecting the principles of personalized medicine. This strategy has emerged as a promising tool for antibiotic stewardship and infection control.

Complications associated with the use of peripherally inserted central catheters and midline catheters in COVID-19 patients: An observational prospective study.

BACKGROUND: Among the many interesting aspects of clinical care during the SARS-CoV-2 pandemic, vascular access still deserves some attention. Peripherally inserted central catheters (PICCs) and midline catheters (MCs) are venous access devices inserted by ultrasound-guided puncture of veins of the arm, which have been associated with the possibility of minimizing infectious complications in different populations of patients. We have investigated their performance in SARS-CoV-2 patients. METHODS: As the incidence of catheter-related bloodstream infections (CRBSI) in patients hospitalized for COVID-19 is still unclear, we have designed a single-center, prospective observational study enrolling all patients with established diagnosis of SARS-CoV-2 infection who were admitted to our hospital in the period between October 2020 and April 2021 and who required either a PICC or a MC. RESULTS: We recruited 227 patients. The cumulative incidence of CRBSI was 4.35% (10 cases), that is, 3.5 episodes/1,000 catheter days. Four CRBSI occurred in patients with PICCs (4.5/1,000 catheter days) and 6 in those with MCs (3.2/1,000 catheter days). CONCLUSIONS: Our data suggest that COVID-19 patients may have a more pronounced tendency for the development of catheter-related infections compared to other populations of patients.

European recommendations on the proper indication and use of peripheral venous access devices (the ERPIUP consensus): A WoCoVA project.

Since several innovations have recently changed the criteria of choice and management of peripheral venous access (new devices, new techniques of insertion, new recommendations for maintenance), the WoCoVA Foundation (WoCoVA = World Conference on Vascular Access) has developed an international Consensus with the following objectives: to propose a clear and useful classification of the currently available peripheral venous access devices; to clarify the proper indication of central versus peripheral venous access; discuss the indications of the different peripheral venous access devices (short peripheral cannulas vs long peripheral cannulas vs midline catheters); to define the proper techniques of insertion and maintenance that should be recommended today. To achieve these purposes, WoCoVA have decided to adopt a European point of view, considering some relevant differences of terminology between North America and Europe in this area of venous access and the need for a common basis of understanding among the experts recruited for this project. The ERPIUP Consensus (ERPIUP = European Recommendations for Proper Indication and Use of Peripheral venous access) was designed to offer systematic recommendations for clinical practice, covering every aspect of management of peripheral venous access devices in the adult patient: indication, insertion, maintenance, prevention and treatment of complications, removal. Also, our purpose was to improve the standardization of the terminology, bringing clarity of definition, and classification.

Chest-to-arm tunneling: A novel technique for medium/long term venous access devices.

BACKGROUND: Chest-to-arm (CTA) tunneling has been described recently as a technique that allows an optimal exit site at mid-arm even in chronically ill patients with complex clinical issues and challenging problems of vascular access. METHOD: We adopted CTA tunneling in oncologic and in non-oncologic patients, in totally implanted and in external devices, for both medium and long-term intravenous treatments. We report our experience with 60 cases of CTA tunneling: 19 patients requiring a totally implantable device, who had bilateral contraindication to venous access at the arm and bilateral contraindication to placement of the pocket in the infra-clavicular area; 41 patients requiring an external central venous catheter, who had bilateral contraindication to insertion of peripherally inserted central catheters or femoral catheters, as well as contraindication to an exit site in the infraclavicular area. All venous access devices were inserted with ultrasound guidance and tip location by intracavitary electrocardiography, under local anesthesia. RESULTS: There were no immediate or early complications. Patients with CTA-ports had no late complications. In patients with CTA-tunneled external catheters, there were two dislodgments, four episodes of central line associated blood stream infections, and one local infection. There were no episodes of venous thrombosis or catheter malfunction. CONCLUSION: Our experience suggests that CTA tunneling is a safe maneuver, with very low risk of complications, and should be considered as an option in patients with complex venous access.

Taurolidine lock in the treatment of colonization and infection of totally implanted venous access devices in cancer patients.

BACKGROUND: Taurolidine lock is known to be effective in preventing catheter-related infections in a variety of venous access devices, including long term venous access devices for chemotherapy. Though, literature about the use of taurolidine for treating catheter colonization or catheter-related blood stream infection is scarce. METHOD: We have retrospectively reviewed the safety and efficacy of 2% taurolidine lock for treatment of catheter-colonization and of catheter-related bloodstream infection in cancer patients with totally implanted venous access devices. Diagnosis of colonization or catheter-related infection was based on paired peripheral and central blood cultures, according to the method of Delayed Time to Positivity. RESULTS: We recorded 24 cases of catheter-related infection and two cases of colonization. Taurolidine lock-associated with systemic antibiotic therapy-was successful in treating all cases of catheter-related infection, with disappearance of clinical symptoms, normalization of laboratory values, and eventually negative blood cultures. Taurolidine lock was also safe and effective in treating device colonization. No adverse effect was reported. CONCLUSION: In our retrospective analysis, 2% taurolidine lock was completely safe and highly effective in the treatment of both catheter-colonization and catheter-related bloodstream infection in cancer patients with totally implanted venous access devices.

Effect of Lockdowns on Hospital Staff in a COVID Center: A Retrospective Observational Study.

At the onset of the SARS-CoV-2 pandemic, individual and social measures were strengthened through restrictive non-pharmaceutical interventions, labelled with the term "lockdown". In Italy, there were two lockdowns (9 March 2020−3 May 2020 and 3 November 2020−27 March 2021). As part of preventive measures, healthcare workers and the administrative staff population of Policlinico A. Gemelli underwent nasopharyngeal swab tests from 1 March 2020 to 9 February 2022, a long time interval that includes the two aforementioned lockdowns. The population included 8958 people from 1 March 2020 to 31 December 2020; 8981 people from 1 January 2021 to 31 December 2021; and 8981 people from 1 January 2022 to 9 February 2022. We then analysed pseudo-anonymized data, using a retrospective observational approach to evaluate the impact of the lockdown on the incidence of SARS-CoV-2 infections within the population. Given the 14 day contagious period, the swab positivity rate (SPR) among the staff decreased significantly at the end of the first lockdown, every day prior to 18 May 2020, by 0.093 (p < 0.0001, CI = (−0.138−−0.047)). After the fourteenth day post the end of the first lockdown (18 May 2020), the SPR increased daily at a rate of 0.024 (p < 0.0001, 95% CI = (0.013−0.034)). In addition, the SPR appeared to increase significantly every day prior to 17 November 2020 by 0.024 (p < 0.0001, CI = (0.013−0.034)). After the fourteenth day post the start of the second lockdown (17 November 2020), the SPR decreased daily at a rate of 0.039 (p < 0.0001, 95% CI = (−0.050−−0.027)). These data demonstrate that, in our Institution, the lockdowns helped to both protect healthcare workers and maintain adequate standards of care for COVID and non-COVID patients for the duration of the state of emergency in Italy.

Prospective clinical study on the incidence of catheter-related complications in a neurological intensive care unit: 4 years of experience.

INTRODUCTION: Over the past decades, significant efforts have been made to reduce early and late catheter-related complications in critically ill patients, using approaches based on bundles of evidence-based interventions. METHODS: In this prospective clinical study, the authors evaluated the incidence of catheter-related complications in their neuro-intensive care unit during a 4-year period, adopting systematically the GAVeCeLT bundles for the insertion and management of all central venous access devices: centrally inserted central catheters (CICCs), peripherally inserted central catheters (PICCs) and femorally inserted central catheters (FICCs). All early/immediate and late complications were recorded. RESULTS: On 486 central lines (328 CICCs, 149 PICCs and 9 FICCs), the only clinically relevant early/immediate complication was primary tip malposition (1%). In regards late infective complications, the authors did not record any case of catheter-related bloodstream infection; though, they observed one case of central line associated blood stream infection (one CICC; 0.14/1000 catheter days), and 15 cases of catheter colonization (12 CICCs and 3 PICCs; 2.09 episodes/1000 catheter days). Late non-infective complications were few: 14 accidental dislodgments (2.9%), 18 irreversible lumen occlusions (3.7%), and no episodes of symptomatic catheter-related thrombosis or tip migration. CONCLUSION: The systematic adoption of the GAVeCeLT bundles for CVAD insertion and maintenance was associated with a minimization of catheter-related complications. The strict adherence to the recommendations included in these bundles was the major determinant for clinical success.

Risk of thrombophlebitis associated with continuous peripheral infusion of vancomycin: The effect of dilution.

INTRODUCTION: Although several guidelines recommend that prolonged administration of vancomycin should be preferably carried out by a central venous access, vancomycin is often given peripherally. Whether such risk may be affected by different modalities of administration in terms of dilution and time of infusion, it is a matter of controversy. METHODS: This single-center prospective study enrolled all consecutive patients requiring prolonged intravenous infusion of vancomycin (1 g/day) using long peripheral cannula "mini-midline." Patients were randomized in study group (4 mg/ml) and control group (20 mg/ml). All patients were systematically evaluated every 24 h by the Visual Exit-Site Score and a daily ultrasound scan of the veins of the arm. RESULTS: The daily ultrasound evaluation showed venous thrombosis at the distal tip of the cannula in all patients, in both groups. After this finding in the first 14 patients, the study was interrupted. All thromboses were completely asymptomatic and occurred in absence of any sign of catheter malfunction. The onset of thrombosis was significantly earlier in the control group (ranging from 24 to 48 h) than in the study group (ranging from 48 to 96 h), with an average of 30 ± 11 versus 68 ± 16 h (p < 0.001). CONCLUSION: Continuous intravenous infusion of vancomycin should be preferably delivered by a central venous access, as largely recommended by current guidelines, since peripheral infusion is inevitably associated with venous thrombosis, independently from the type of peripheral venous access device adopted (short peripheral cannula vs long peripheral cannula) and from the extent of dilution.

Management of antithrombotic treatment and bleeding disorders in patients requiring venous access devices: A systematic review and a GAVeCeLT consensus statement.

Insertion of venous access devices (VAD) is usually considered a procedure with low risk of bleeding. Nonetheless, insertion of some devices is invasive enough to be associated with bleeding, especially in patients with previous coagulopathy or in treatment with antithrombotic drugs for cardiovascular disease. The current practices of platelet/plasma transfusion in coagulopathic patients and of temporary suspension of the antithrombotic treatment before VAD insertion are based on local policies and are often inadequately supported by evidence, since many of the clinical studies on this topic are not recent and are not of high quality. Furthermore, the protocols of antithrombotic treatment have changed during the last decade, after the introduction of new oral anticoagulant drugs. Though some guidelines address some of these issues in relation with specific procedures (port insertion, etc.), no evidence-based document covering all the aspects of this clinical problem is currently available. Thus, the Italian Group of Venous Access Devices (GAVeCeLT) has decided to develop a consensus on the management of antithrombotic treatment and bleeding disorders in patients requiring VADs. After a systematic review of the available evidence, the panel of the consensus (which included vascular access specialists, surgeons, intensivists, anesthetists, cardiologists, vascular medicine experts, nephrologists, infective disease specialists, and thrombotic disease specialists) has structured the final recommendations as detailed answers to three sets of questions: (1) which is an appropriate classification of VAD-related procedures based on the specific bleeding risk? (2) Which is the appropriate management of the patient with bleeding disorders candidate to VAD insertion/removal? (3) Which is the appropriate management of the patient on antithrombotic treatment candidate to VAD insertion/removal? Only statements reaching a complete agreement were included in the final recommendations, and all recommendations were offered in a clear and synthetic list, so to be easily translated into clinical practice.

Ten years of clinical experience with cyanoacrylate glue for venous access in a 1300-bed university hospital.

In the past decade, cyanoacrylate glue has been progressively introduced into the clinical practice of venous access devices used for different purposes. Glue has been used to increase device stabilisation (to reduce the risk of catheter dislodgement), to seal the exit site (to both reduce local bleeding and decrease the risk of bacterial contamination) and to close skin incisions required for the insertion of tunnelled catheters or totally implanted venous ports. For many of these purposes, the efficacy and cost-effectiveness of cyanoacrylate glue has been demonstrated, while some indications are still controversial. This article reports on 10 years of clinical experience with cyanoacrylate glue in a large university hospital, and provides a narrative review of the scientific evidence on the benefits of glue in venous access that has been accumulating over the past decade.

Cerebrospinal Fluid Shunt Infections in Children: Do Hematologic and Cerebrospinal Fluid White Cells Examinations Correlate With the Type of Infection?

BACKGROUND: Cerebrospinal fluid (CSF) shunt infections in children represent an increasing problem in clinical practice. However, comprehensive clinical, laboratory and microbiologic data are scarce in pediatric age. METHODS: We conducted a 10-year retrospective study to (1) analyze clinical, laboratory and microbiologic parameters associated with infections in children; (2) analyze results according to the type of catheter (medicated or not), type of infection (first or relapses), type of hydrocephalus (acquired and congenital), presence or not of bacteriemia; (3) describe antibiotic susceptibilities and their evolution during the study period. RESULTS: Eighty-seven children with shunt infection and 61 children with mechanical shunt malfunction were enrolled. Fever, vomit, leukocytosis and elevated C-reactive protein were more frequent in the infected group (P < 0.001), while neurologic symptoms developed more frequently in the noninfected group (10.3% vs. 27.87%; P = 0.006). Local signs of inflammation and abdomen distension were similarly reported in the 2 groups. Children with medicated shunts had lower cell count in the CSF (12/mm3) compared with those with nonmedicated shunts (380/mm3; P < 0.0001). Gram-negative bacteria were more common in the not-medicated catheters (90.91% vs. 50% of cultures; P = 0.04). Gram-negative bacteria were identified in 50.67% of CSF cultures, Gram-positive bacteria in 53.33% and fungi were observed in 5.33%. Sixteen children (18.4%) had also a positive blood culture. Enterococci isolation was associated with relapsed infections (37.50% vs. 15.25%; P = 0.05). CONCLUSIONS: Our study shows that the diagnosis and management of children with shunt infections are challenging. Prospective studies with a comprehensive approach focusing on patient, medical, microbiologic and surgical risk factors for first infection are urgently needed.

Ultrasound-guided cannulation of the superficial femoral vein for central venous access.

BACKGROUND: In some clinical conditions, central venous access is preferably or necessarily achieved by threading the catheter into the inferior vena cava. This can be obtained not only by puncture of the common femoral vein at the groin, but also-as suggested by few recent studies-by puncture of the superficial femoral vein at mid-thigh. METHODS: We have retrospectively reviewed our experience with central catheters inserted by ultrasound-guided puncture and cannulation of the superficial femoral vein, focusing mainly on indications, technique of venipuncture, and incidence of immediate/early complications. RESULTS: From June 2020 to December 2020, we have inserted 98 non-tunneled central venous catheters (tip in inferior vena cava or right atrium) by ultrasound-guided puncture of the superficial femoral vein at mid-thigh or in the lower third of the thigh, all of them secured by subcutaneous anchorage. The success of the maneuver was 100% and immediate/early complications were negligible. Follow-up of hospitalized patients (72.5% of all cases) showed only one episode of catheter dislodgment, no episode of infection and no episode of catheter related thrombosis. CONCLUSIONS: The ultrasound approach to the superficial femoral vein is an absolutely safe technique of central venous access. In our experience, it was not associated with any risk of severe insertion-related complications, even in patients with low platelet count or coagulation disorders. Also, the exit site of the catheter at mid-thigh may have advantages if compare to the exit site in the inguinal area.

WoCoVA consensus on the clinical use of in-line filtration during intravenous infusions: Current evidence and recommendations for future research.

The need for filtering intravenous infusions has long been recognized in the field of venous access, though hard scientific evidence about the actual indications for in-line filters has been scarce. In the last few years, several papers and a few clinical studies have raised again this issue, suggesting that the time has come for a proper definition of the type of filtration, of its potential benefit, and of its proper indications in clinical practice. The WoCoVA Foundation, whose goal is to increase the global awareness on the risk of intravenous access and on patients' safety, developed the project of a consensus on intravenous filtration. A panel of experts in different aspects of intravenous infusion was chosen to express the current state of knowledge about filtration and to indicate the direction of future research in this field. The present document reports the final conclusions of the panel.

Lung ultrasound predicts non-invasive ventilation outcome in COVID-19 acute respiratory failure: a pilot study.

BACKGROUND: The aim of this study is to determine relationships between lung aeration assessed by lung ultrasound (LUS) with non-invasive ventilation (NIMV) outcome, intensive care unit (ICU) admission and mechanical ventilation (MV) needs in COVID-19 respiratory failure. METHODS: A cohort of adult patients with COVID-19 respiratory failure underwent LUS during initial assessment. A simplified LUS protocol consisting in scanning six areas, three for each side, was adopted. A score from 0 to 3 was assigned to each area. Comprehensive LUS score (LUSsc) was calculated as the sum of the score in all areas. LUSsc, the amount of involved sonographic lung areas (LUSq), the number of lung quadrants radiographically infiltrated and the degree of oxygenation impairment at admission (SpO2/FiO2 ratio) were compared to NIMV Outcome, MV needs and ICU admission. RESULTS: Among 85 patients prospectively included in the analysis, 49 of 61 needed MV. LUSsc and LUSq were higher in patients who required MV (median 12 [IQR 8-14] and median 6 [IQR 4-6], respectively) than in those who did not (6 [IQR 2-9] and 3 [IQR 1-5], respectively), both P<0.001. NIMV trial failed in 26 patients out 36. LUSsc and LUSq were significantly higher in patients who failed NIMV than in those who did not. From ROC analysis, LUSsc ≥12 and LUSq ≥5 gave the best cut-off values for NIMV failure prediction (AUC=0.95, 95%CI 0.83-0.99 and AUC=0.81, 95% CI 0.65-0.91, respectively). CONCLUSIONS: Our data suggest LUS as a possible tool for identifying patients who are likely to require MV and ICU admission or to fail a NIMV trial.