Integrated short peripheral intravenous cannulas and risk of catheter failure: A systematic review and meta-analysis.

BACKGROUND: Short peripheral catheters (SPCs) are used to provide intravenous therapies in hospitalized patients. Recently, the category of SPC has become more complex, with the introduction in clinical practice of "integrated" SPCs (ISPCs), renewed regarding the material (polyurethane rather than polytetrafluoroethylene) and design (large wing; pre-assembled extension; preassembled needle-free connector (NFC)). METHODS: This systematic review and meta-analysis aimed to analyze randomized controlled trials (RCTs) and quasi-randomized studies in hospitalized patients, analyzing the risk of overall catheter failure as well as the risk of each type of complication (occlusion, infiltration, thrombophlebitis, and dislodgement) for ISPCs compared to non-integrated SPCs. These systematic review and meta-analysis were registered on PROSPERO (CRD42022322970). DATA SOURCES: We searched PUBMED®, EMBASE®, and the Cochrane Controlled Clinical Trials register from April to November 2022. RESULTS: INCLUDED STUDIES: The research identified 1260 articles. After the abstract review, 13 studies were included for full manuscript review and, after that, six papers (4727 patients) were included in the meta-analysis. DESCRIPTION OF THE EFFECT: We found a significantly reduced risk of catheter failure (pooling all complications) for ISPCs compared to SPCs (p = 0.002 RR 0.65; 95% CI 0.63-0.9). A significant reduction in the risks of occlusion (p = 0.007 RR 0.72; 95% CI 0.56-0.92) was observed. As regards the risk of infiltration, thrombophlebitis, and dislodgement, the analysis showed a trend in favor of ISPCs, though not statistically significant (respectively p = 0.2 RR 0.84; 95% CI 0.64-1.1; p = 0.25 RR 0.91; 95% CI 0.78-1.07; p = 0.06 RR 0.72; 95% CI 0.52-1.01). CONCLUSIONS: ISPCs significantly reduce the risks of catheter failure (overall complications) and occlusion. More RCTs are needed to understand if the preassembled ISPC is better than the composted closed system (non-integrated SPC + extension line + NFC).

Femoral venous access: State of the art and future perspectives.

In the past 5 years, non-dialysis femoral venous access has changed in terms of indications, techniques of insertion, and expected incidence of complications. To the traditional non-emergency indication for femoral catheters-obstruction of the superior vena cava-many other indications have been added, both in intensive and non-intensive care. The insertion technique has evolved, thanks to ultrasound guided venipuncture, tunneling, and ultrasound based intraprocedural tip location. Insertion of femorally inserted central catheters may be today regarded as a procedure with an extremely low intraprocedural and post-procedural risk. The risk of infection is reduced by the possibility of the exit site at mid-thigh, by the use of cyanoacrylate glue for sealing the exit site, and by appropriate intraprocedural strategies of infection prevention. The risk of catheter-related thrombosis is low, due to several concomitant strategies: a proper match between vein diameter and catheter caliber; an accurate intraprocedural assessment of tip location by ultrasound and/or intracavitary ECG; the consistent use of ultrasound guided venipuncture and micro-introducer kits; an adequate stabilization of the catheter at the exit site. The risk of mechanical complications and the risk of lumen occlusion are minimized when using polyurethane, power injectable catheters. All these novelties have brought a revolution in the field of femoral venous access, so that this route may be considered as safe and effective as other approaches to central venous catheterization.

A GAVeCeLT bundle for PICC-port insertion: The SIP-Port protocol.

In the last decade, a new type of brachial port has been introduced in clinical practice, the so-called "PICC-port." This is a brachial port, but inserted according to the methodologies and technologies currently adopted for the insertion of peripherally inserted central catheters (PICCs). Several studies have shown that PICC-port insertion is safe, not associated with any relevant immediate or early complication, and that the expected incidence of late complications is significantly lower if compared to "traditional" brachial ports (i.e. inserted without ultrasound guidance). Furthermore, PICC-ports yield excellent esthetic results and are associated with optimal patient compliance. This paper describes an insertion bundle-developed by GAVeCeLT, the Italian Group of Long Term Venous Access Devices, and nicknamed "SIP-Port" (Safe Insertion of PICC-Ports)-which consists of few evidence-based strategies aiming to further minimize all immediate, early, or late complications potentially associated with PICC-port insertion. Also, this insertion bundle has been developed for the purpose of defining more closely the differences between a traditional brachial port and a PICC-port. The SIP-Port bundle is currently adopted by all training courses on PICC-port insertion held by GAVeCeLT. It includes eight steps: (1) preprocedural ultrasound assessment utilizing the RaPeVA (Rapid Peripheral Venous Assessment) protocol; (2) appropriate skin antiseptic technique and maximal barrier precautions; (3) choice of appropriate vein, in terms of caliber and site; (4) clear identification of the median nerve and of the brachial artery during the venipuncture; (5) ultrasound-guided puncture and cannulation of the vein; (6) ultrasound-guided tip navigation; (7) intra-procedural assessment of tip location by intracavitary ECG or by trans-thoracic echocardiography; (8) appropriate creation and closure of the subcutaneous pocket.

Continuous vs Intermittent Meropenem Administration in Critically Ill Patients With Sepsis: The MERCY Randomized Clinical Trial.

Importance: Meropenem is a widely prescribed ß-lactam antibiotic. Meropenem exhibits maximum pharmacodynamic efficacy when given by continuous infusion to deliver constant drug levels above the minimal inhibitory concentration. Compared with intermittent administration, continuous administration of meropenem may improve clinical outcomes. Objective: To determine whether continuous administration of meropenem reduces a composite of mortality and emergence of pandrug-resistant or extensively drug-resistant bacteria compared with intermittent administration in critically ill patients with sepsis. Design, Setting, and Participants: A double-blind, randomized clinical trial enrolling critically ill patients with sepsis or septic shock who had been prescribed meropenem by their treating clinicians at 31 intensive care units of 26 hospitals in 4 countries (Croatia, Italy, Kazakhstan, and Russia). Patients were enrolled between June 5, 2018, and August 9, 2022, and the final 90-day follow-up was completed in November 2022. Interventions: Patients were randomized to receive an equal dose of the antibiotic meropenem by either continuous administration (n = 303) or intermittent administration (n = 304). Main Outcomes and Measures: The primary outcome was a composite of all-cause mortality and emergence of pandrug-resistant or extensively drug-resistant bacteria at day 28. There were 4 secondary outcomes, including days alive and free from antibiotics at day 28, days alive and free from the intensive care unit at day 28, and all-cause mortality at day 90. Seizures, allergic reactions, and mortality were recorded as adverse events. Results: All 607 patients (mean age, 64 [SD, 15] years; 203 were women [33%]) were included in the measurement of the 28-day primary outcome and completed the 90-day mortality follow-up. The majority (369 patients, 61%) had septic shock. The median time from hospital admission to randomization was 9 days (IQR, 3-17 days) and the median duration of meropenem therapy was 11 days (IQR, 6-17 days). Only 1 crossover event was recorded. The primary outcome occurred in 142 patients (47%) in the continuous administration group and in 149 patients (49%) in the intermittent administration group (relative risk, 0.96 [95% CI, 0.81-1.13], P = .60). Of the 4 secondary outcomes, none was statistically significant. No adverse events of seizures or allergic reactions related to the study drug were reported. At 90 days, mortality was 42% both in the continuous administration group (127 of 303 patients) and in the intermittent administration group (127 of 304 patients). Conclusions and Relevance: In critically ill patients with sepsis, compared with intermittent administration, the continuous administration of meropenem did not improve the composite outcome of mortality and emergence of pandrug-resistant or extensively drug-resistant bacteria at day 28. Trial Registration: ClinicalTrials.gov Identifier: NCT03452839.

Assessment of the MAGIC recommendations in context of evolving evidence based on the use of PICC in ICU.

The goal of the 2015 Michigan Appropriateness Guide for Intravenous Catheters (MAGIC) was to define indications and appropriate practices for peripherally inserted central catheters (PICC) use; however, MAGIC recommendations virtually reduced the use of PICC in hospital settings, including critical care. The aim of this review is to present an assessment of the MAGIC guidelines, considering contemporary evidence to date. The validity of the MAGIC recommendations and their applicability to current practice are called into question given important concerns with the methodology for their development (e.g. high volume of clinical scenarios for evaluation) and the supporting evidence used. There is a considerable amount of contemporary evidence not considered in MAGIC that reports on evolving practices, techniques, and technologies targeted to reduce complications associated with central venous access devices (CVADs). Recent evidence dictates that CVADs are necessary in the intensive care unit (ICU), and that PICCs are a safe, reliable, and appropriate type of central lines, which cannot be replaced in several ICU situations. In light of evolving evidence and practice, as well as the methodological concerns identified, the MAGIC guidelines should be revisited. It is also recommended to create a clinical assessment tool that identifies potential uses of specific CVADs, based on patient needs. The choice of the CVAD should be based on unique clinical considerations and current scientific evidence, not on fears informed by antiquated data.

The integrated short peripheral cannula: A new peripheral venous access device?

Short peripheral intravenous cannulas have different features, as they may be winged or non-winged, ported or non-ported, equipped or not with needle stick prevention and "blood stop" mechanisms, and integrated or not with preassembled extensions or preassembled needle free connector. In the current range of commercially available short peripheral cannulas, there is one device that is apparently associated with several clinical advantages. In fact, short peripheral cannulas with safety mechanisms, closed system, winged, non-ported, and equipped with preassembled extension and preassembled needle-free connector appear to be associated with prolonged dwell time, reduction of the incidence of several complications (infiltration/extravasation, dislodgement, phlebitis, infection, blood leakage), cost reduction, and increased satisfaction of patients and clinicians. To clarify the current terminology and to identify this device for future clinical studies, the authors advocate the use of the term "integrated short peripheral cannula." A rapid review of the current evidence suggests that this new device may have different clinical performance and different indications if compared to standard short peripheral cannulas. Though, the optimal clinical outcome can be achieved only when the device is inserted and maintained with proper protocols.

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.

Time to abandon chest X-rays in favor of intracavitary ECG or echocardiography for central venous access tip location: A case of a malpositioned CICC into the internal mammary vein.

Central vascular access devices (CVADs) correct tip location is of paramount importance to avoid malposition related complications. Despite recent guidelines recommend avoiding postprocedure radiograph in favor of alternative tip location technology, chest X-rays are still widely used in clinical practice as a CVADs tip location method. We present a clinical case of a central inserted central catheter (CICC) malposition in the right internal mammary vein, erroneously interpreted by chest X-rays as correctly placed, in a critically ill patient.

A 5-year experience with midline catheters in the management of major head and neck surgery patients.

BACKGROUND: In the perioperative management of major head and neck surgery (HNS) patients, the performance of midline catheters (MCs) has been never tested. We present here our 5-year experience by reporting MC-related complications and by identifying the preoperative risk factors associated with their development. METHODS: Clinical variables were extracted and the dwell time, the number, and the type of postprocedural complications of MCs were retrieved. Complications were classified into major (needing MCs removal and including catheter-related bloodstream infection or deep vein thrombosis or catheter occlusion) and into minor (accidental dislodgement, leaking, etc.). Descriptive statistics and logistic regression models were used in order to identify the predictors of complications. RESULTS: A total of 265 patients were included, with a mean age of 67.4 years. Intraprocedural complications occurred in 1.1% of cases, while postprocedural complications occurred in 13.9% of cases (12.05/1000 days), but they were minor in more than 7.0% (5.4/1000 catheter-days). There were 19 minor complications (7.1% or 5.4/1000 catheter-days) while 18 (7%, 5.1/1000 catheter-days) patients experienced at least one major complication. Female sex (OR = 1.963, 95% CI 1.017-3.792), insertion in the right arm (OR = 2.473, 95% CI 1.150-5.318), and an ACE-27 score >1 (OR = 2.573, 95% CI 1.295-5.110) were independent predictors of major complications. CONCLUSIONS: MCs appear to represent an effective option in the setting of major HNS. The identification of patients most at risk for MC-related complications should prompt a postoperative watchful evaluation.

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.

A multicenter retrospective study on 4480 implanted PICC-ports: A GAVeCeLT project.

BACKGROUND: PICC-ports may be defined as totally implantable central venous devices inserted in the upper limb using the current state-of-the-art techniques of PICC insertion (ultrasound-guided venipuncture of deep veins of the arm, micro-puncture kits, proper location of the tip preferably by intracavitary ECG), with placement of the reservoir at the middle third of the arm. A previous report on breast cancer patients demonstrated the safety and efficacy of these devices, with a very low failure rate. METHODS: This retrospective multicenter cohort study-developed by GAVeCeLT (the Italian Group of Long-Term Venous Access Devices)-investigated the outcomes of PICC-ports in a large cohort of unselected patients. The study included 4480 adult patients who underwent PICC-port insertion in five Italian centers, during a period of 60 months. The primary outcome was device failure, defined as any serious adverse event (SAE) requiring removal. The secondary outcome was the incidence of temporary adverse events (TAE) not requiring removal. RESULTS: The median follow-up was 15.5 months. Device failure occurred in 52 cases (1.2%), the main causes being local infection (n = 7; 0.16%) and CRBSI (n = 19; 0.42%). Symptomatic catheter-related thrombosis occurred in 93 cases (2.1%), but removal was required only in one case (0.02%). Early/immediate and late TAE occurred in 904 cases (20.2%) and in 176 cases (3.9%), respectively. CONCLUSIONS: PICC-ports are safe venous access devices that should be considered as an alternative option to traditional arm-ports and chest-ports when planning chemotherapy or other long-term intermittent intravenous treatments.

The state of vascular access teams: Results of a European survey.

BACKGROUND: Many European health institutions have appointed multidisciplinary teams for the general management of vascular access to help improve efficiency, patient safety and reduce costs. Vascular access teams (VATs), or infusion teams, are specifically trained groups of healthcare professionals who assess, place, manage and monitor various outcomes and aspects of vascular access care. OBJECTIVE: To assess the current landscape of vascular access management as a discipline across Europe. METHODS: A Faculty of European VAT leads and experts developed a survey of 20 questions which was disseminated across several European countries. Questions focused on respondent and institution profile, vascular access device selection and placement, monitoring and reporting of complications, and access to training and education. The 1449 respondents included physicians, nurses, anaesthetists, radiologists and surgeons from public and private institutions ranging in size. RESULTS: Availability of dedicated VATs vary by country, institution size, and institution type. Institutions with a VAT are more likely to utilise a tool (eg, algorithm or guideline) to determine the appropriate vascular access device (55% vs 38%, P < .0002) and to have feedback on systematic monitoring of complications (40% vs 28%, P = .015). Respondents from institutions with a VAT are more likely to have received training on vascular access management (79% vs 53%, P < .0001) and indicated that the VAT was a source of support when difficulties arise. CONCLUSION: The survey results highlight some of the potential benefits of implementing a dedicated VAT including the use of a broader range of vascular access devices, increased awareness of the presence of vascular access policies, increased the likelihood of recent vascular access training, and increased rates of systematic monitoring of associated complications. The study reveals potential areas for further focus in the field of vascular access care, specifically examining the direct impact of vascular access teams.

Qualitative interviews and supporting evidence to identify the positive impacts of multidisciplinary vascular access teams.

BACKGROUND: Vascular access by means of intravenous catheters is essential for the safe, effective and cost-efficient delivery of intravenous fluids, antibiotics, nutrition and chemotherapy, but the use of these devices is not without complications. PURPOSE: A faculty of multidisciplinary European vascular access team (VAT) Leads/Members and experts sought to reframe how the implementation of a VAT could have positive impacts on patients and hospitals. METHODS: Interview data from a Faculty of nine VAT Leads/Members and experts from six European countries on the impact of multidisciplinary VATs in modern healthcare were assessed. A literature search was conducted that included Medline®-cited peer-reviewed articles published in the past 10 years in order to identify impact data and post-implementation of a multidisciplinary VAT that support the benefits to patient safety and satisfaction and to hospital efficiencies reported in the interview program. RESULTS: While VATs vary in structure and function, clarity of purpose and supportive training and education are key. Barriers to the implementation of VATs show commonality across countries, such as lack of investment, insufficient training and lack of awareness. Proven markers of VAT success include rapid referrals, improved patient outcomes and improved organizational efficiency. Standardization of outcomes data capture, processing and reporting are key to monitoring performance against baseline. Awareness of the cost of complications arising from inappropriate choice and placement, and poor care and maintenance, of the vascular access device must be raised. CONCLUSIONS: The implementation of VATs can positively impact patient safety and satisfaction, improve organizational efficiencies and cost-effectiveness, and could create new opportunities for in- and outpatient services, beneficial to both patients and institutions.

The right methodology for long-term vascular access research: Three burning questions.

Over the last 20 years, there has been a great proliferation of studies of different aspects of the long-term vascular access field. Despite the availability of such studies, methodological pitfalls surrounding long-term vascular access research are rarely mentioned. Methodological issues inherent to retrospective analyses make them very poor tools for providing generalizable results, as they often become estimates of local experiences rather than reflections of up-to-date practices. Second, despite being an often-ignored element when designing studies on catheter-related complications, a proper follow-up time definition and its length are crucial to limiting the impact of attrition bias on research results. Finally, meta-analyses constitute a powerful tool in modern evidence-based era, but several pitfalls can affect overall results. When designing a systematic review and meta-analytic process, study selection should always reflect the relevance of clinical questions and the capability to contextualize results in the modern and evidence-based vascular access era.

GAVeCeLT-WoCoVA Consensus on subcutaneously anchored securement devices for the securement of venous catheters: Current evidence and recommendations for future research.

BACKGROUND: Subcutaneously anchored securement devices (or subcutaneous engineered securement devices) have been introduced recently into the clinical practice, but the number of published studies is still scarce. The Italian Group of Long-Term Central Venous Access Devices (GAVeCeLT)-in collaboration with WoCoVA (World Congress on Vascular Access)-has developed a Consensus about the effectiveness, safety, and cost-effectiveness of such devices. METHODS: After the definition of a panel of experts, a systematic collection and review of the literature on subcutaneously anchored securement devices was performed. The panel has been divided in two working groups, one focusing on adult patients and the other on children and neonates. RESULTS: Although the quality of evidence is generally poor, since it is based mainly on non-controlled prospective studies, the panel has concluded that subcutaneously anchored securement devices are overall effective in reducing the risk of dislodgment and they appear to be safe in all categories of patients, being associated only with rare and negligible local adverse effects; cost-effectiveness is demonstrated-or highly likely-in specific populations of patients with long-term venous access and/or at high risk of dislodgment. CONCLUSION: Subcutaneously anchored securement is a very promising strategy for avoiding dislodgment. Further studies are warranted, in particular for the purpose of defining (a) the best management of the anchoring device so to avoid local problems, (b) the patient populations in which it may be considered highly cost-effective and even mandatory, (c) the possible benefit in terms of reduction of other catheter-related complications such as venous thrombosis and/or infection, and-last but not least-(d) their impact on the workload and stress level of nurses taking care of the devices.

In defense of the use of peripherally inserted central catheters in pediatric patients.

Central venous access devices have revolutioned the care of children affected by malignancies, facilitating management of complex and prolonged infusive therapies, reducing pain and discomfort related to repeated blood samples and indiscriminate venipunctures, thus reducing also psychological stress of both patients and families. In this respect, peripherally inserted central catheters have been disseminated for use, even in pediatric oncology patients, for their many advantages: easy and non-invasive placement with no risk of insertion-related complications, as well as easy removal; reduced need for general anesthesia both for insertion and removal; adequate prolonged performance also for challenging therapies (e.g. stem cell transplantation); and low rate of late complications. Nonetheless, concerns have been recently raised about use of such devices in children with cancer, especially regarding a presumed (but not demonstrated) high risk of catheter-related venous thrombosis. Are we facing a new witch (or peripherally inserted central catheter) hunt? The choice of the central venous access device-particularly in oncologic children-should be based on an evaluation of clinical advantages and risks, as provided by appropriate and scientifically accurate clinical studies.

Intracavitary electrocardiography for tip location during central venous catheterization: A narrative review of 70 years of clinical studies.

Intracavitary electrocardiography is an accurate and non-invasive method for central venous access tip location. Using the catheter as a traveling intracavitary electrode, intracavitary electrocardiography is based on the increase in the detected amplitude of the P wave while approaching the cavoatrial junction. Despite having been adopted diffusely in clinical practice only in the last years, this method is not novel. In fact, it has first been described in the late 40s, during electrophysiological studies. After a long period of quiescence, it is in the last two decades of the XX century that intracavitary electrocardiography became popular as an effective mean of central venous catheters tip location. But the golden age of this technique began with the new millennium, as documented by high-quality studies in this period. In fact, in those years, intracavitary electrocardiography has been studied broadly, and important achievements in terms of comprehension of the technique, accuracy, and feasibility of the method in different populations and conditions (i.e. pediatrics, renal patients, atrial fibrillation) have been gained. In this review, we describe the technique, its history, and its current perspectives.

Reconsidering the GAVeCeLT Consensus on catheter-related thrombosis, 13 years later.

Catheter-related thrombosis represents one of the most common complications following central venous access insertion. Despite the amount of available studies, many aspects surrounding catheter-related thrombosis remain controversial. Thirteen years ago, the Italian Study Group for Long Term Central Venous Access (GAVeCeLT) developed a nationwide Consensus in order to clarify some key aspects on this topic. Despite most of them still remain valid, however, knowledge around catheter-related thrombosis has greatly evolved over the last decade, with a natural evolution in terms of catheter technologies, insertion techniques, and management bundles. Aims of this editorial are to readdress conclusions of the 2007 GAVeCeLT Consensus in the light of the new relevant evidences that have been added in the last 13 years and to analyze some unsolved issues that still remain debated.