A new wireless device for bedside assessment of tip location of central venous access devices using intracavitary ECG: A retrospective study.

Intracavitary electrocardiography (IC-ECG) is a non-invasive method for intraprocedural tip location during central venous catheterization. Over the last 20 years, the IC-ECG method has been thoroughly investigated and many studies have confirmed its wide applicability and feasibility, as well as its great accuracy and safety in different populations of patients and in different types of central venous access devices (CVADs). This retrospective study presents a two-center experience with tip location of central venous catheters using IC-ECG, by means of a new wireless portable device. Tip location was performed during 983 insertions of CVADs at bedside, using this new device. Clinical conditions with limited or no applicability of IC-ECG were excluded. The feasibility of IC-ECG, as performed using the novel device, was 92.2%. This wireless device may play an important role in central venous catheterization at bedside, since it is pocket-sized, particularly easy to use, and easy to sanify after use.

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).

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.

Safe Insertion of Arterial Catheters (SIA): An ultrasound-guided protocol to minimize complications for arterial cannulation.

Direct puncture and cannulation of peripheral arteries is frequently performed in critical care and in emergency settings, mainly for hemodynamic monitoring and blood sampling. While there is abundant literature on peripheral arterial cannulation in children and adults, there is still scope for clinical improvements which may impact on patient safety. Although the radial artery is the most frequently utilized access site today, due to its superficial proximity, ease of access, and low risk of adverse events, other sites are sometimes chosen. The authors propose the Safe Insertion of Arterial Catheters (SIA) protocol, an ultrasound-guided insertion bundle applying a systematic approach to arterial cannulation, with a focus on improving insertion practices, reducing procedural complications, increasing the patient safety profile, and improving device performance.

Subcutaneously anchored securement for peripherally inserted central catheters: Immediate, early, and late complications.

BACKGROUND: An adequate stabilization of a vascular device is an important part of insertion bundles and is an effective strategy in reducing complications. Dislodgment has a relevant clinical impact and an increase in healthcare costs. METHOD: We have retrospectively investigated the safety and efficacy of Subcutaneously Anchored Securement (SAS) for Peripherally Inserted Central Catheters (PICC) in cancer patients. RESULTS: We analyzed 639 patients who had a PICC inserted and secured with SAS, over the past 3 years (2018-2020). No immediate complications during SAS placement were reported. In the first 24-48 h, a slight local ecchymosis was reported in 24 cases with rapid spontaneous resolution. No cases of bleeding or hematoma of the exit site were reported. The total number of catheter days was 93078. Dislodgment occurred only in seven cases (1.1%). In 16 patients, the PICC was removed because of catheter-related bloodstream infection (CRBSI): the overall incidence of CRBSI was 0.17 per 1000 catheter days. Symptomatic venous thrombosis was documented in 12 patients (1.9%) and treated with low molecular weight heparin without PICC removal. We had no cases of irreversible lumen occlusion. In 17 patients, local discomfort-including device-related pressure ulcers and painful inflammation-was reported: these cases were treated without SAS removal or PICC removal. CONCLUSION: In this retrospective analysis, subcutaneously anchored securement of PICCs was a safe and effective strategy for reducing the risk of dislodgment.

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.

The SIC protocol: A seven-step strategy to minimize complications potentially related to the insertion of centrally inserted central catheters.

Insertion of central venous catheters in the cervico-thoracic area is potentially associated with the risk of immediate/early untoward events, some of them negligible (repeated punctures), some relevant (accidental arterial puncture), and some severe (pneumothorax). Furthermore, different strategies adopted during insertion may reduce or increase the incidence of late catheter-related complications (infection, venous thrombosis, dislodgment). This paper describes a standardized protocol (S.I.C.: Safe Insertion of Centrally Inserted Central Catheters) for the systematic application of seven basic beneficial strategies to be adopted during insertion of central venous catheters in the cervico-thoracic region, aiming to minimize immediate, early, or late insertion-related complications. These strategies include: preprocedural evaluation, appropriate aseptic technique, ultrasound guided insertion, intra-procedural assessment of the tip position, adequate protection of the exit site, proper securement of the catheter, and adequate coverage of the exit site.

The SIF protocol: A seven-step strategy to minimize complications potentially related to the insertion of femorally inserted central catheters.

The insertion of central venous catheters through the femoral veins is not uncommon and is potentially associated with the risk of immediate puncture-related complications and severe late complications as infection and thrombosis. As for other central venous access devices, the use of a standardized protocol of insertion and the correct application of evidence-based strategies are beneficial in reducing the risk of complications. We proposed a standardized protocol (S.I.F.: Safe Insertion of Femorally Inserted Central Catheters) consisting of seven strategies that should be part of vascular cannulation and should be adopted during the insertion of femoral venous catheters, aiming to minimize immediate, early and late insertion-related complications. These strategies include: preprocedural evaluation of the patient history and of the veins, appropriate aseptic technique, ultrasound guided puncture and cannulation of the vein, intra-procedural assessment of the tip position, adequate protection of the exit site, proper securement of the catheter, and appropriate coverage of the exit site.

The SIP protocol update: Eight strategies, incorporating Rapid Peripheral Vein Assessment (RaPeVA), to minimize complications associated with peripherally inserted central catheter insertion.

Insertion of Peripherally Inserted Central Catheters (PICCs) is potentially associated with the risk of immediate/early adverse events, some of them minimal (repeated punctures) and some relevant (accidental arterial puncture or nerve-related injury). Several strategies adopted during the insertion process may minimize the risk of such events, including late complication risks such as infection, venous thrombosis, or catheter dislodgment and/or malposition. This paper describes an update version of the SIP protocol (Safe Insertion of PICCs), an insertion bundle which includes eight effective strategies that aims to minimize immediate, early, or late insertion-associated complications. These strategies include: preprocedural ultrasound assessment utilizing the RaPeVA (Rapid Peripheral Venous Assessment) protocol; appropriate skin antiseptic technique; choice of appropriate vein, adoption of the Zone Insertion Method™; clear identification of the median nerve and brachial artery; ultrasound-guided puncture; ultrasound-guided tip navigation; intra-procedural assessment of tip location; correct securement of the catheter, and appropriate protection of the exit site. This updated version of the SIP protocol includes several novelties based on the most recent evidence-based scientific literature on PICC insertion, such as the clinical relevance of the tunneling technique, the use of ultrasound for intra-procedural tip navigation and tip location, and the new technologies for the protection of the exit site (cyanoacrylate glue) and for the securement of the catheter (subcutaneous anchorage).

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.

Preprocedural ultrasound vascular assessment is essential to decision-making.

Reliable venous access should be part of the clinical-therapeutic path of all cancer patients. A correct preliminary ultrasound evaluation of the patient's veins and the choice of the suitable vein are the fundamental requirements to guarantee a stable and long-lasting venous access.

Rapid Femoral Vein Assessment (RaFeVA): A systematic protocol for ultrasound evaluation of the veins of the lower limb, so to optimize the insertion of femorally inserted central catheters.

In this paper we describe a new protocol-named RaFeVA (Rapid Femoral Vein Assessment)-for the systematic US assessment of the veins in the inguinal area and at mid-thigh, designed to evaluate patency and caliber of the common and superficial femoral veins and choose the best venipuncture site before insertion of a FICC.

A novel ultrasound-guided approach to the axillary vein: Oblique-axis view combined with in-plane puncture.

INTRODUCTION: Ultrasound-guided cannulation of the axillary vein in the infraclavicular area has several potential advantages for both short-term and long-term venous access devices. Currently, there are two techniques to approach axillary vein for ultrasound-guided cannulation: out-of-plane puncture in the short-axis view and the in-plane puncture in the long-axis view. We propose a novel ultrasound-guided puncture technique of axillary vein for centrally inserted central catheter placement, which consists in the oblique-axis view of the axillary vein coupled with the in-plane puncture. The main objectives of this study were feasibility and safety of this approach. The primary endpoints were the success rate and early complications; the secondary endpoints were late complications. METHODS: We analyzed data from a retrospective cohort of 80 ultrasound-guided cannulation of axillary vein performed with the oblique axis-in-plane technique in 80 cancer patients requiring a totally implantable central venous access, at CRO Aviano National Cancer Institute, during the period from January 2016 up to October 2017. We focused on the percentage of successful venous cannulation at the first attempt and on the cumulative incidence of early and late complications. RESULTS: Axillary vein cannulation was successful at the first attempt in 77 out of 80 patients (96%). We had no significant complications during placement or in the first 48 h. The total number of catheter days was 27,432. The cumulative incidence of catheter-related bloodstream infection was of 0.036 per 1000 catheter days (only one case). We had no infection of the pocket of the reservoir, no symptomatic venous thrombosis, and no catheter migration. CONCLUSION: Our data show that the oblique axis-in-plane technique of the ultrasound approach to the axillary vein is feasible and safe.

The mystery of the occluded port that allowed blood withdrawal: is it safe to use standard needles to access ports? A case report and literature review.

A frequent complication of totally implantable central venous access devices (TIVADs) is withdrawal occlusion. We describe a case of rare dysfunction of TIVADs: blood withdrawal was possible, whereas infusion was not. A further investigation demonstrated that during infusion, a silicone core, probably produced by hypodermic needle puncture, occluded the reservoir outlet hole. The silicone septum puncture by standard needles instead of non-coring ones may reduce the device effectiveness and expose patients to serious complications.