Venous Access: National Guideline and Registry Development (VANGUARD): Advancing Patient-Centered Venous Access Care Through the Development of a National Coordinated Registry Network.

There are over 8 million central venous access devices inserted each year, many in patients with chronic conditions who rely on central access for life-preserving therapies. Central venous access device-related complications can be life-threatening and add tens of billions of dollars to health care costs, while their incidence is most likely grossly mis- or underreported by medical institutions. In this communication, we review the challenges that impair retention, exchange, and analysis of data necessary for a meaningful understanding of critical events and outcomes in this clinical domain. The difficulty is not only with data extraction and harmonization from electronic health records, national surveillance systems, or other health information repositories where data might be stored. The problem is that reliable and appropriate data are not recorded, or falsely recorded, at least in part because policy, payment, penalties, proprietary concerns, and workflow burdens discourage completeness and accuracy. We provide a roadmap for the development of health care information systems and infrastructure that address these challenges, framed within the context of research studies that build a framework of standardized terminology, decision support, data capture, and information exchange necessary for the task. This roadmap is embedded in a broader Coordinated Registry Network Learning Community, and facilitated by the Medical Device Epidemiology Network, a Public-Private Partnership sponsored by the US Food and Drug Administration, with the scope of advancing methods, national and international infrastructure, and partnerships needed for the evaluation of medical devices throughout their total life cycle.

Research Priorities for Percutaneous Arteriovenous Fistula Creation in Patients with End-Stage Renal Disease: Proceedings and Recommendations from a Multidisciplinary Research Consensus Panel.

Recently developed endovascular techniques to create percutaneous arteriovenous fistulas are an alternative to surgical arteriovenous fistula creation, although there is currently a lack of high-level evidence regarding their creation, maturation, utilization, and long-term function. Recognizing this, the Society of Interventional Radiology Foundation sponsored a Research Consensus Panel and Summit for the prioritization of a research agenda to identify and address the gaps in current knowledge.

Long-term central venous access in pediatric patients at high risk: conventional versus antibiotic-impregnated catheters.

PURPOSE: To study selective use of antibiotic-impregnated catheters in children at increased risk of venous catheter-related infections (CRIs). MATERIALS AND METHODS: From December 2008 to June 2009, 428 peripherally inserted central catheters (PICCs) were placed by the interventional radiology service of a large metropolitan children's hospital. This retrospective study analyzed demographic and outcome data for the 125 patients in this group at high risk for venous CRI. Patients at high risk were those with active systemic infection, previous complicated central venous access, intensive care unit (ICU) admission, intestinal failure, transplantation, complex congenital heart disease, or renal failure. Patients (age, 7.6 y ± 7.0; 73 male and 52 female) received a conventional or antibiotic-impregnated PICC, with 17 receiving more than one catheter. RESULTS: Of the 146 of 428 qualifying patient encounters (34%), 53 patients received an antibiotic-impregnated PICC and 93 received a conventional PICC, representing 5,080 total catheter-days (CDs). The rates of CRIs per 1,000 CDs, including catheter exit site infections and catheter-related bloodstream infections, were 0.86 for antibiotic-impregnated PICCs and 5.5 for conventional PICCs (P = .036). A propensity-based model predicts 15-fold greater infection-free survival over the lifetime of the catheter in patients who receive an antibiotic-impregnated PICC (P < .001). Antibiotic-impregnated PICC recipients with active infection or ICU admission at the time of insertion had no catheter-associated infections, compared with 3.42 and 9.46 infections per 1,000 CDs, respectively, for patients who received conventional PICCs. Patients with intestinal failure had 1.49 and 10 infections per 1,000 CDs with antibiotic-impregnated versus conventional PICCs, respectively. CONCLUSIONS: Antibiotic-impregnated long-term PICCs significantly improve infection-free catheter survival in pediatric patients at high risk.

Radiologically placed tunneled hemodialysis catheters: a single pediatric institutional experience of 120 patients.

PURPOSE: To report the outcome of tunneled dialysis catheter insertion in 120 patients. MATERIALS AND METHODS: A retrospective review of the interventional radiology database and electronic medical records of 120 patients who had tunneled dialysis catheters inserted from April 1997 to July 2010 was performed with institutional review board approval. There were 61 female patients and 59 male patients, with a mean age of 13.3 years (range, 0.2-28.5 y). A total of 193 primary insertions and 330 salvage procedures were performed. RESULTS: The technical success rate for primary catheter insertions was 100%. Immediate complications included self-limiting tract bleeding and air embolism in two of 193 insertions each (1.03%). Mean indwell duration for primary insertions was 66 catheter-days (range, 1-765 d), compared with a total mean of 159.4 catheter-days (range, 1-1,034 d). Rates of infection and mechanical complications were 0.21 and 0.9 per 100 total catheter-days, respectively. Mechanical and infections complications were increased in children younger than 9 years of age and weighing less than 20 kg. The catheter removal rates for infection and mechanical complications were 0.084 and 0.081 per 100 catheter-days, respectively. Medical salvage procedures, ie, intracatheter thrombolytic agent use or antibiotic therapy (52.1%) and interventional radiologic catheter salvage procedures (47.1%), increased catheter survival by an average of 54.8 days (range, 0-959 d). CONCLUSIONS: Radiologic placement of tunneled hemodialysis catheters is a safe and technically successful procedure in pediatric patients. However, there is a high rate of infectious and mechanical complications, particularly in younger and smaller patients.

Botulinum toxin A injection of salivary glands in children with drooling and chronic aspiration.

PURPOSE: To review outcomes of ultrasound (US)-guided percutaneous submandibular gland injection of botulinum toxin A (BTX-A) in the treatment of drooling and chronic aspiration. MATERIALS AND METHODS: A 3-year retrospective review was performed of 220 US-guided salivary gland injections in 36 patients. There were 21 male patients and 15 female patients with an age range of 1.4 to 19.8 years (mean, 8.6 y) and a weight range of 7.8 to 73 kg (mean, 24.4 kg). The mean pretreatment analysis period was 48 months and the mean follow-up period was 21 months. The study group was divided into groups with anterior (n = 9) and posterior (n = 27) drooling, with those with both (n = 10) included in the posterior group. RESULTS: All procedures were technically successful. Bilateral submandibular injections were performed in 34 procedures and bilateral submandibular and parotid injections were performed in 38 procedures. Of the 27 patients with posterior drooling, improvement occurred in 24 patients (88%), no improvement was seen in two (8%), and one (4%) was lost to follow-up. Of the nine patients with anterior drooling, six (66%) showed improvement, there was no response in two (22%), and one (12%) was lost to follow-up. The total number of hospitalizations for respiratory issues and presumed aspiration pneumonia decreased by 56.4% per year in the patients with posterior drooling. There was one procedure-related complication: an episode of self-limited oral bleeding. CONCLUSION: Salivary gland BTX-A injection for salivary control shows promising results in decreasing saliva production and frequency of respiratory symptoms in children with drooling and chronic aspiration.

Evidence-Based Strategies and Recommendations for Preservation of Central Venous Access in Children.

Children with chronic illness often require prolonged or repeated venous access. They remain at high risk for venous catheter-related complications (high-risk patients), which largely derive from elective decisions during catheter insertion and continuing care. These complications result in progressive loss of the venous capital (patent and compliant venous pathways) necessary for delivery of life-preserving therapies. A nonstandardized, episodic, isolated approach to venous care in these high-need, high-cost patients is too often the norm, imposing a disproportionate burden on affected persons and escalating costs. This state-of-the-art review identifies known failure points in the current systems of venous care, details the elements of an individualized plan of care, and emphasizes a patient-centered, multidisciplinary, collaborative, and evidence-based approach to care in these vulnerable populations. These guidelines are intended to enable every practitioner in every practice to deliver better care and better outcomes to these patients through awareness of critical issues, anticipatory attention to meaningful components of care, and appropriate consultation or referral when necessary.

Recommended Clinical Trial End Points for Dialysis Catheters.

Central venous catheters are used frequently in patients on hemodialysis as a bridge to a permanent vascular access. They are prone to frequent complications, including catheter-related bloodstream infection, catheter dysfunction, and central vein obstruction. There is a compelling need to develop new drugs or devices to prevent central venous catheter complications. We convened a multidisciplinary panel of experts to propose standardized definitions of catheter end points to guide the design of future clinical trials seeking approval from the Food and Drug Administration. Our workgroup suggests diagnosing catheter-related bloodstream infection in catheter-dependent patients on hemodialysis with a clinical suspicion of infection (fever, rigors, altered mental status, or unexplained hypotension), blood cultures growing the same organism from the catheter hub and a peripheral vein (or the dialysis bloodline), and absence of evidence for an alternative source of infection. Catheter dysfunction is defined as the inability of a central venous catheter to (1) complete a single dialysis session without triggering recurrent pressure alarms or (2) reproducibly deliver a mean dialysis blood flow of >300 ml/min (with arterial and venous pressures being within the hemodialysis unit parameters) on two consecutive dialysis sessions or provide a Kt/V≥1.2 in 4 hours or less. Catheter dysfunction is defined only if it persists, despite attempts to reposition the patient, reverse the arterial and venous lines, or forcefully flush the catheter. Central vein obstruction is suspected in patients with >70% stenosis of a central vein by contrast venography or the equivalent, ipsilateral upper extremity edema, and an existing or prior history of a central venous catheter. There is some uncertainty about the specific criteria for these diagnoses, and the workgroup has also proposed future high-priority studies to resolve these questions.

CT-guided percutaneous steroid injection for management of inflammatory arthropathy of the temporomandibular joint in children.

OBJECTIVE: The purposes of this study were to retrospectively review an injection technique, to develop a grading system for evaluation of imaging findings, and to report preliminary outcome related to percutaneous CT-guided steroid injection into the temporomandibular joints of children with inflammatory arthropathy. CONCLUSION: CT-guided steroid injection into the temporomandibular joint of children with inflammatory arthropathy results in clinical and imaging improvement in a substantial proportion of children treated.

Advancing medical device innovation through collaboration and coordination of structured data capture pilots: Report from the Medical Device Epidemiology Network (MDEpiNet) Specific, Measurable, Achievable, Results-Oriented, Time Bound (SMART) Think Tank.

The Medical Device Epidemiology Network (MDEpiNet) is a public private partnership (PPP) that provides a platform for collaboration on medical device evaluation and depth of expertise for supporting pilots to capture, exchange and use device information for improving device safety and protecting public health. The MDEpiNet SMART Think Tank, held in February, 2013, sought to engage expert stakeholders who were committed to improving the capture of device data, including Unique Device Identification (UDI), in key electronic health information. Prior to the Think Tank there was limited collaboration among stakeholders beyond a few single health care organizations engaged in electronic capture and exchange of device data. The Think Tank resulted in what has become two sustainable multi-stakeholder device data capture initiatives, BUILD and VANGUARD. These initiatives continue to mature within the MDEpiNet PPP structure and are well aligned with the goals outlined in recent FDA-initiated National Medical Device Planning Board and Medical Device Registry Task Force white papers as well as the vision for the National Evaluation System for health Technology.%.