Use Of Central Venous Access Devices Research Articles

Use of Peripheral Intravenous Access in Patients Undergoing Chemotherapy for Testicular Cancer.

Systemic chemotherapy, depending on the regimen, can be administered through peripheral intravenous (pIV) access or through central venous access devices (CVADs). There is no current best practice regarding optimal access for chemotherapy for patients with testicular cancer (TC). We retrospectively evaluated patients undergoing systemic chemotherapy for TC and compared baseline characteristics and complications of patients using pIV versus CVADs. We included patients with TC who underwent first-line systemic chemotherapy at the University of Colorado Hospitals from 2005 to 2020. Data were collected on demographics, cancer characteristics, type, duration of chemotherapy, pIV or CVAD use, and associated complication rates. We then performed univariate and multivariate regression analyses to compare complication rates and risk factors for each group. One hundred fifty-four patients met inclusion criteria. Ninety-two (60%) patients used CVADs, and 62 patients (40%) used pIV for their initial treatment. Only six (9.7%) of 62 patients transitioned from pIV to CVADs during therapy. Similarly, 10 of 92 (10.9%) patients with initial CVAD needed to transition to a different type of CVAD or to pIV (P = .81). There were a greater number of venous access-related complications (48 of 92 patients, 52.2%) and overall thrombotic events (33 of 92 patients, 35.9%) for the CVAD group (P > .001) when compared with the pIV group. We observed an association between the following factors and venous access-related complications during chemotherapy: higher stage TC, increased total chemotherapy cycles, and delayed therapy. Peripheral IV use for first-line nonvesicant chemotherapy in patients with TC appears to be well tolerated with high rates of therapy completion and lower rates of complications when compared with CVADs. These data support our preferred treatment approach and provide evidence that pIV access is a safe and effective way to deliver chemotherapy for patients with TC.

Factors influencing the optimal selection of central venous access devices: A qualitative study of health care team members’ perspectives

ObjectiveThis study aimed to explore health care team members’ understanding of the factors influencing the optimal selection of central venous access devices (CVADs). MethodsThe data of the study was collected using semi-structured interviews. Twenty-six hospital medical staff (four hospital manager, 15 head nurses, 7 nurse) with experience in peripheral or central catheterization from four regions (Northern China, Southern China, Northwest China, and Qinghai-Tibet China) in China were interviewed between June and October 2021. Content analysis was used to analyze the data. ResultsThe results revealed five themes and 14 sub-themes. Patients: concerns, resources, requirements, and evaluation (security concerns, support resources, life requirements, evaluation among patients); nurses: awareness, knowledge, and popularizing methods (awareness of intravenous therapy, understanding of professional knowledge, forms of popularizing methods); doctors: support and involvement (support for decision-making, involvement in intravenous work); hospital managers: authority, quality control and continuing education (management of catheterization authority, quality control of intravenous infusion, investment in continuing education) and environment: differences and commonalities (differences in social support, and current commonalities). ConclusionNurses and other healthcare team members’ understanding, selection, use, and recommendation of CVADs have an indirect effect on patients’ decision-making. Therefore, hospital managers and government departments can indirectly strengthen medical team cooperation and improve learning education in order to improve the safety of patients receiving intravenous infusions.

Control of Line Complications with KiteLock (CLiCK) in the critical care unit: study protocol for a multi-center, cluster-randomized, double-blinded, crossover trial investigating the effect of a novel locking fluid on central line complications in the critical care population

BackgroundInsertion of a central venous access device (CVAD) allows clinicians to easily access the circulation of a patient to administer life-saving interventions. Due to their invasive nature, CVADs are prone to complications such as bacterial biofilm production and colonization, catheter-related bloodstream infection, occlusion, and catheter-related venous thrombosis. A CVAD is among the most common interventions for patients in the intensive care unit (ICU), exposing this vulnerable population to the risk of nosocomial infection and catheter occlusion. The current standard of care involves the use of normal saline as a catheter locking solution for central venous catheters (CVCs) and peripherally inserted central catheter (PICC) lines, and a citrate lock for hemodialysis catheters. Saline offers little prophylactic measures against catheter complications. Four percent of tetrasodium ethylenediaminetetraacetic acid (EDTA) fluid (marketed as KiteLock Sterile Locking Solution™) is non-antibiotic, possesses antimicrobial, anti-biofilm, and anti-coagulant properties, and is approved by Health Canada as a catheter locking solution. As such, it may be a superior CVAD locking solution than the present standard of care lock in the ICU patient population.MethodsOur team proposes to fill this knowledge gap by performing a multi-center, cluster-randomized, crossover trial evaluating the impact of 4% tetrasodium EDTA on a primary composite outcome of the incidence rate of central line-associated bloodstream infection (CLABSI), catheter occlusion leading to removal, and use of alteplase to resolve catheter occlusion compared to the standard of care. The study will be performed at five critical care units.DiscussionIf successful, the results of this study can serve as evidence for a shift of standard of care practices to include EDTA locking fluid in routine CVAD locking procedures. Completion of this study has the potential to improve CVAD standard of care to become safer for patients, as well as provides an opportunity to decrease strain on healthcare budgets related to treating preventable CVAD complications. Success and subsequent implementation of this intervention in the ICU may also be extrapolated to other patient populations with heavy CVAD use including hemodialysis, oncology, parenteral nutrition, and pediatric patient populations. On a global scale, eradicating biofilm produced by antibiotic-resistant bacteria may serve to lessen the threat of “superbugs” and contribute to international initiatives supporting the termination of antibiotic overuse.Trial registrationClinicalTrials.gov NCT04548713, registered on September 9th, 2020.

Long-term IV access in paediatrics - why, what, where, who and how.

Establishment of long-term central venous access imposes the risk of procedural adverse events (air embolism, pneumothorax, accidental arterial cannulation of the great vessels, tricuspid valve damage and cardiac tamponade) as well as the risk of increased morbidity and mortality due to catheter related blood stream infections, vessel stenosis, deep vein thrombosis and the often high risk anaesthetic management of syndromic children. This narrative review aims to provide a historical and clinical background for the development and use of CVADs (central venous access devices), origin and management of the most common complications (catheter related thrombosis, infections and persistent withdrawal occlusion) and present the reader with an update on the "why, what, where, who and how" in paediatric long-term central venous access. Finally, we will present the reader with a clinical method for applying a retrograde inserted tunnelled and cuffed catheter using the left brachiocephalic vein access.

PRO105 COMPLICATIONS ASSOCIATED WITH CENTRAL VENOUS ACCESS DEVICES IN PATIENTS WITH HEMOPHILIA A (PWHA): A SECONDARY CLAIMS-BASED ANALYSIS

To evaluate incidence of complications associated with central venous access devices (CVADs) in PwHA. This retrospective cohort study was conducted using claims data from MarketScan Commercial Research Database from 07.01.2005–03.31.2019. The study cohort comprised PwHA and included CVAD cases (≥1 CVAD insertion claim), and controls with no CVAD insertion claim through the study period. Patients were required to have continuous enrollment for 6 months pre- and at least 3 months post-index date. Index date was defined as the first date of port insertion for CVAD cases and first hemophilia A (HA) diagnosis for controls during the study period. HA was identified using a previously validated claims-based algorithm. CVAD use and complications (all-cause infections, thrombosis and hematoma) were identified using ICD-9-CM/ICD-10-CM diagnosis/procedure and CPT codes. Patients were followed until first outcome, plan switch or over a 2-year post-index period. Incidence and rates of complications among CVAD cases and controls were evaluated using Cox proportional-hazards models (adjusted for age, region, comorbidity score, and insurance type). The study cohort comprised 862 PwHA; 61 (7%) had evidence of CVAD use. CVAD cases were significantly younger than controls (mean age ± SD: 4.7±5.3 years vs. 25.9±17.5 years, p<0.001) and had a significantly higher Elixhauser comorbidity score (mean ± SD: 0.9±0.6 vs. 0.5±0.8, p<0.001). In the post-index period, a significantly higher proportion of CVAD cases (vs. controls) had all-cause infections (44.3% vs. 26.7%, p<0.001) and thrombosis (13.1% vs. 1.1%, p<0.001). No CVAD cases had evidence of hematoma; it occurred in 1.5% of controls. Cox models revealed that CVAD cases had 2.3 times (95%CI: 1.5–3.6) and 9.2 times (95%CI: 2.4–35.6) higher rate of all-cause infections and thrombosis, respectively. CVAD use in HA is associated with higher rates of complications, underscoring the need for novel non-intravenous treatments which remove the need for CVADs.

Utility of Blood Cultures and Empiric Antibiotics in Febrile Pediatric Hemophilia Patients With Central Venous Access Devices.

Children with hemophilia frequently require long-term central venous access devices (CVADs) for regular infusion of factor products. Hemophilia patients are not immunocompromised, but the presence and use of CVADs are associated with infections including bacteremia. Currently, the utility of blood cultures in evaluation of the febrile hemophilia patient with an indwelling CVAD is unknown, nor is optimal empiric antibiotic use. We performed a retrospective cross-sectional study of febrile immunocompetent hemophilia patients with CVADs presenting to a large academic urban pediatric emergency department from 1995 to 2017. We used a natural language processing electronic search, followed by manual chart review to construct the cohort. We analyzed rate of pathogen recovery from cultures of blood in subgroups of hemophilia patients, the pathogen profile, and the reported pathogen susceptibilities to ceftriaxone. Natural language processing electronic search identified 181 visits for fever among hemophilia patients with indwelling CVADs of which 147 cases from 44 unique patients met study criteria. Cultures of blood were positive in 56 (38%) of 147 patients (95% confidence interval, 30%-47%). Seventeen different organisms were isolated (10 pathogens and 7 possible pathogens) with Staphylococcus aureus and coagulase-negative Staphylococcus species as the most common. Thirty-four percent of isolates were reported as susceptible to ceftriaxone. Positive blood cultures were more common in cases involving patients with inhibitors (n = 71) versus those without (n = 76), odds ratio, 7.4 (95% confidence interval, 3.5-15.9). This was observed irrespective of hemophilia type. Febrile immunocompetent hemophilia patients with indwelling CVADs have high rates of bacteremia. Empiric antimicrobial therapy should be targeted to anticipated pathogens and take into consideration local susceptibility patterns for Staphylococcus aureus.

Multivariate analysis on complications of central venous access devices in children with cancer and severe disease influenced by catheter tip position and vessel insertion site (A STROBE-compliant study)

ContextReliable long-term central venous access device (CVAD) is essential for the management of pediatric patients with cancer or chronic diseases. However, there is no general consensus for optimal catheter tip location and vessel insertion site in children. ObjectiveThis single center study analyzes the risk of complications associated with long-term upper body CVAD and evaluates them with respect to catheter tip location as well as vessel insertion site. DesignPediatric patients who received long-term upper body CVAD from January 2008 through April 2017 and underwent radiographic documentation of the tip location were retrospectively included in the study. Data on demographics, catheter tip location on chest x-ray, intraoperative vessel insertion sites and postoperative complications were analyzed. Catheter tip location was categorized as “high” (above the right mainstem bronchus), “medium” (at the level of the bronchus), and “low” (below the right mainstem bronchus). Distance to the carina was measured as well. ResultsA total of 396 patients, 74.7% suffering from cancer were included in our study (mean age 6.3 ± 0.3 years). Complications occurred in about one fourth of all patients. Catheter-related blood stream infections (BSI) (n = 40, 36.4%) were most prevalent, but catheter tip position or vessel insertion site had no impact on the risk of infections. Dislodgement (n = 27, 24.6%) and occlusion (n = 11, 10.0%) were more frequent in “high” positioned catheter tips.While there was one patient who developed arrhythmia, no case of cardiac perforation, and in particular, no catheter-related death was recorded in our series. The vessel insertion site seemed to have no influence on the complication frequency of CAVDs. ConclusionThe catheter tip position seems to have an impact on the catheter-related complication profile in children. To avoid complications, we recommend avoiding a “high” localization of the catheter tip above the right main bronchus. “Low” catheter tip placement was associated with the lowest dislocation rate.Given the overall low complication rate, insertion and use of CVADs in children can generally be considered as safe.

Research Progress of Oxidative Stress and MicroRNAs in the Prevention of Catheter-Related Thrombus Under Resistance Exercise.

Central venous access devices (CVADs) have completely changed the care for patients who require long-term venous access. With the widespread use of CVADs, the incidence of catheter-related thrombus (CRT) has increased. Catheter-related thrombus is a common complication in patients who use CVADs and is mainly caused by endothelial injury, blood stasis, and hypercoagulability. In recent years, the correlations between oxidative stress (OS) and microRNA (miRNA) and CRT have become a hot topic in clinical research. When a catheter punctures the vessel wall, it causes OS damage to the vascular endothelial cells, leading to a series of CRT diseases. MicroRNAs can regulate the mechanism of thrombus and play an important role in the formation of anti-thrombus. Numerous studies have shown that resistance exercise can reduce the level of OS in vascular endothelial cells, inhibit vascular endothelial cell dysfunction, and maintain the stability of hemodynamics and biochemical state. In the current work, the recent studies on the effects of resistance exercise on OS and miRNA in vascular endothelial cells were reviewed.

Analysis of central venous access injuries from claims to the Swedish Patient Insurance Company 2009-2017.

Insertion and use of central venous access devices (CVADs) can be associated with serious adverse events. The incidence is generally low but considering the vast use of CVADs the consequences can, from a patient safety and health economics perspective, be severe. No exact knowledge exists of number of catheters or complications in Sweden, as there is currently no comprehensive registry. The aim was to analyse injuries reported to the Swedish National Patient Insurance Company (Löf) within 7days after insertion or removal of a CVAD. A retrospective analysis of all injuries filed in the period 2009-2017 was performed, evaluating patient data, type of catheter, insertion technique and type of injury. If the injury was deemed avoidable by Löf, degree of disability and mortality was registered. A total of 87 claims of injuries were found of which 36 (41%) were assessed as avoidable. The most common injuries were: bleeding (18%), early infection (17%), pneumothorax (17%) and early thrombosis (15%). No patients died of their injuries, but 17 of 36 suffered permanent disability of varying degrees. Ultrasound-guided insertion was used in 19% of the cases. In Sweden, few injuries related to CVAD use are reported to Löf. About 40% of filed claims were categorized as having an avoidable injury and therefore eligible for compensation. About half of the compensated patients suffered a permanent disability. The results indicate underreporting of CVC-related injuries in Sweden during the studied time-period.

Treatment patterns and healthcare resource utilization among patients with hereditary angioedema in the United States

BackgroundReal-world data on usage and associated outcomes with hereditary angioedema (HAE)-specific medications introduced to the United States (US) market since 2009 are very limited. The purpose of this retrospective study was to evaluate real-world treatment patterns of HAE-specific medications in the US and to assess their impact on healthcare resource utilization (HCRU). This analysis used IMS PharMetrics PlusTM database records (2006–2014) of patients with HAE, ≥1 insurance claim for an HAE-specific medication, and continuous insurance enrollment for ≥3 months following the first HAE prescription claim.ResultsOf 631 total patients, 434 (68.8%) reported C1-INH(IV) use; 396 (62.8%) reported using ecallantide and/or icatibant. There were 306 episodes of prophylactic use of C1-INH(IV) (defined by continuous refills averaging ≥1500 IU/week for ≥13 weeks) in 155 patients; use of ≥1 on-demand rescue medication was implicated during 53% (163/306) of those episodes. Sixty-eight (20.2%) of 336 C1-INH(IV) users eligible for the HCRU analysis were hospitalized at least once, and 191 (56.8%) visited the emergency department (ED). Eighteen patients (5.4%) had a central venous access device (CVAD); of these, 5 (27.7%) required hospitalization and 14 (77.7%) had an ED visit. The adjusted relative risk of hospitalization and/or ED visits for patients with a CVAD was 2.6 (95% CI: 0.17, 39.23) compared to C1-INH(IV) users without a CVAD.ConclusionsDespite widespread availability of modern HAE medications in the US, we identified a subset of patients requiring long-term prophylaxis who continue to be burdened by frequent rescue medication usage and/or complications related to the use of CVADs for intravenous HAE medication.

Protocol for a systematic review and thematic synthesis of patient experiences of central venous access devices in anti-cancer treatment

BackgroundThree types of central venous access devices (CVADs)—peripherally inserted central catheters (PICCs), skin-tunnelled central catheters (Hickman-type devices), and implantable chest wall Ports (Ports)—are routinely used in the intravenous administration of anti-cancer treatment. These devices avoid the need for peripheral cannulation and allow for home delivery of treatment. Assessments of these devices have tended to focus on medical and economic factors, but there is increased interest in the importance of patient experiences and perspectives in this area. The aim of this systematic review is to synthesise existing research regarding patient experiences of these CVADs to help clinicians guide, prepare, and support patients receiving CVADs for the administration of anti-cancer treatment.MethodA systematic search of MEDLINE, Embase, and CINAHL research databases will be carried out along with a supplementary reference list search. This review will include quantitative, qualitative, and mixed methods studies published in peer-review journals, reporting some aspect(s) of patient experiences or perspectives regarding the use of PICC, Hickman, or Port CVADs for the administration of anti-cancer drugs. The methodological quality and risk of bias of included papers will be assessed using the Mixed Methods Appraisal Tool (MMAT). Relevant outcome data will be extracted from included studies and analysed using a thematic synthesis approach.DiscussionThe results section of the review will comprise thematic synthesis of quantitative studies, thematic synthesis of qualitative studies, and the aggregation of the two. Results will aim to offer an account of current understandings of patient experiences and perspective regarding PICC, Hickman-type, and Port devices in the context of anti-cancer treatment. Confidence in cumulative evidence will be assessed using the Confidence in the Evidence from Reviews of Qualitative research (CERQual) approach.Systematic review registrationThis systematic review protocol is registered with the International Prospective Register of Systematic Reviews (PROSPERO). Registration number: CRD42017065851. This protocol was prepared using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses for Protocols checklist (PRISMA-P) (Shamseer et al., BMJ 349: 2015).

Central Venous Access Device (CVAD) Use and Complications in Sickle Cell Disease Patients from Medicaid and Commercially-Insured U.S. Populations

Central venous access devices (CVADs), such as tunneled central venous catheters (tCVADs) and peripherally inserted central catheters (PICCs), help provide essential care for some patients with sickle cell disease (SCD). CVADs facilitate administration of multiple intravenous (IV) medications and blood products, as well as blood draws for laboratory analysis. Understanding CVAD use and complications is particularly relevant for SCD patients because of their high risk of having insufficient peripheral IV access. Prior studies describing CVAD use and complications in SCD patients were limited by small sample sizes, typically including 15-20 SCD patients in a single treatment center. The resulting estimates for CVAD use and complications in SCD patients vary widely, are insufficient for development of evidence-based guidelines, and may not be representative of the treatment burden in the broader SCD population. The purpose of this study was to describe the frequency of CVAD use and CVAD-associated complications among SCD patients in a large US population sample.We used data from two large U.S. insurance claims databases from Truven Health MarketScan® Research to examine both Medicaid-insured and commercially-insured SCD patients. From January 2009 through December 2013, these databases encompassed over 14 million Medicaid-insured and over 116 million commercially-insured patients. SCD patients were defined as patients with at least two International Classification of Disease-9 (ICD-9) diagnosis codes for SCD (282.41-42, 282.6x) on separate dates in excess of sickle cell trait codes, or one ICD-9 code for an inpatient (emergency department or hospitalization) visit with sickle cell crisis. CVAD insertions were identified using relevant procedure codes for tCVADs or PICCs. We conducted two sets of analyses for each database: (1) per patient among those with at least one CVAD insertion, and (2) per CVAD insertion. We conducted descriptive analyses on the frequency of CVAD-related procedures (e.g., repair, replacement, removal of obstructive material, repositioning), complications, and infections, thromboses, or phlebitis.A total 17,119 Medicaid-insured SCD patients and 21,342 commercially-insured SCD patients were observed for an average of 3-4 years, during which 1,945 (11.4%) and 1,316 (6.2%) patients, respectively, had at least one CVAD insertion. Most SCD patients (80%) were aged >18 y at time of first CVAD insertion; 18% of adult Medicaid SCD patients had at least one CVAD inserted. The mean number of CVAD insertions per patient was 3.1 (Medicaid) and 2.4 (commercially-insured). In the per CVAD analysis, complication claims were frequent, including infection (31-37%), thrombosis (4-5%), and phlebitis/thrombophlebitis (12-15%). The mean time to removal of CVADs (duration) was 31-34 days (PICC lines) and 102 days (tCVADs). In the per patient analysis, 54.3% had infection claims, 24.3% had thrombosis claims, and 10.2% had phlebitis/thrombophlebitis claims in Medicaid (see Table and Figure; additional results to be provided, also stratified by age).Both tCVADs and PICCs were commonly used in SCD patients, particularly adults, with high occurrence of infection, thrombosis and phlebitis/thrombophlebitis, as well as repeated CVAD insertions. Determinants of CVAD use and complications warrant further investigation to inform practice standards. These findings from a large observational study indicate that device-related risks of administering IV treatments are limitations of IV treatment options and may add to SCD treatment burden.Table 1Medicaid-InsuredCommercially-InsuredAny CVAD (Overall)PICC OnlytCVAD OnlyBoth PICC and tCVADAny CVAD (Overall)PICC OnlytCVAD OnlyBoth PICC and tCVADN (%)1,945681 (35.0%)893 (45.9%)371 (19.1%)1,316450 (34.2%)664 (50.5%)202 (15.3%)Age, mean (sd) y30.0 (16.3)34.2 (14.9)26.9 (17.5)30.1 (13.6)32.6 (17.1)34.1 (15.8)31.3 (18.3)33.2 (15.9)CVAD insertions per patient, mean (sd)3.1 (3.9)3.1 (3.9)1.8 (1.3)6.2 (5.8)2.4 (2.3)2.5 (2.6)1.6 (1.0)4.5 (2.9)CVAD insertions total6,1073,6512,456n/a3,0821,6361,446n/aDuration per CVAD, median days4431102n/a5334102n/aCVAD complications, % patients with CVADComplication, general28.8%13.2%31.8%50.1%22.3%9.1%25.9%39.6%Removal of obstructive material11.2%3.8%15.3%14.6%9.0%2.4%11.4%15.3%Replacement8.3%3.7%10.2%12.4%6.5%3.8%6.5%12.9% [Display omitted] DisclosuresMaserejian:Biogen: Employment, Equity Ownership. Hayflinger:Biogen: Consultancy, Employment. Eaton:Biogen: Employment, Equity Ownership. Madigan:Biogen: Employment, Equity Ownership. Hobbs:Biogen: Employment, Equity Ownership.

Burden of Illness Among Pediatric Hemophilia Patients with and without Central Venous Access Devices Treated in U.S. Hospitals

Introduction: Central venous access devices (CVADs) are valuable tools to facilitate repeated or urgent treatments for hemophilia patients. However, CVADs may increase the risk for local and systemic infection, as well as thrombosis. There is limited real-world information on the use of CVADs among the pediatric hemophilia population treated in a hospital setting. The aim of this study was to describe and compare the characteristics and burden of illness of the hemophilia population with and without CVADs.Methods: This observational study used data from the Premier research database and included inpatients and outpatients who were age ≤ 18 years at the time of index admission and discharged during 2006-2014 from one of 548 U.S. hospitals. We identified hemophilia patients using principal or secondary ICD-9 diagnosis codes 286.0x or 286.1x, and CVAD exposure using billing information that represented the procedure with or without a corresponding ICD-9 procedure code of 86.07. We matched CVAD to non-CVAD exposed patients using a 1:1 matching scheme based on age (+/- 1 year), Factor-VIII therapy (yes/no), Factor-IX therapy (yes/no), number of prior HCP encounters in previous 365 days (+/- 5), previous hospitalization for infection in previous 365 days (yes/no), and geography (9 census region categories). Comparisons of outcomes including infections, thrombosis, revisit rates, and length of stay between groups were made using Wilcoxon signed rank tests for medians and generalized linear models for categorical variables to account for correlation between matched pairs, stratified by inpatients and outpatients.Results: There were a total of 4,793 eligible pediatric hemophilia patients during the study period. Of these, 197 (4.1%) had CVAD exposure according to our criteria. The matched sample included 163 CVAD cases and 163 controls (142 inpatients and 184 outpatients).The inpatient hemophilia population was median age 5 years, primarily male (93%), white (55%), treated in urban hospitals (94%) in the south region (46%), and had Medicaid as the primary payer (47%). Compared with the non-CVAD group, patients with CVAD exposure in the pre-matched group were more often male (98% vs. 92%), younger (3 vs. 5 years), and treated in urban (98% vs. 94%), teaching hospitals (79% vs. 64%). Among the inpatient matched sample, CVAD cases compared with controls experienced a greater frequency of all-cause 30-day (24% vs. 11%, p=0.03), 60-day (31% % vs. 13%, p=0.01), and 90-day (33% vs. 17%, p=0.02) outpatient revisits, and more all-cause infections (12% vs. 2%, p=0.02), but no notable difference in the frequency of thrombosis (4% vs. 2%, p=0.48) or inpatient revisits. The median hospital length of stay for inpatients was greater for CVAD cases compared with controls (4 vs. 3 days, p=0.01).The outpatient hemophilia population was slightly older (median age 9 years) and less often male (82%) or treated in urban hospitals (82%), but otherwise had similar demographic characteristics to the inpatient population; 58% white, with 49% in the South and 45% having Medicaid as the primary payer. Compared with the non-CVAD group, outpatients with CVAD exposure in the pre-matched group were more often male (97% vs. 82%), younger (4 vs. 9 years), and treated in urban (92% vs 82%), teaching hospitals (61% vs. 39%). Among the outpatient matched sample, CVAD cases compared with controls had greater frequencies of subsequent inpatient and outpatient visits at 30-, 60-, and 90-days (all p< 0.05), as well as all-cause infections (24% vs. 3%, p=0.0001) and thrombosis (9% vs. 0.9%, p=0.03).Conclusions: CVAD exposure was associated with a greater frequency of infections, thrombosis, and inpatient and outpatient revisit rates, as well as longer length of stay, among pediatric hemophilia patients treated in U.S. hospitals. The results of this study may inform research efforts for novel treatments best suited to the unique needs of hemophilia patients with CVADs. DisclosuresBuckley:Biogen: Employment. Dreyfus:Premier, Inc.: Employment, Equity Ownership, Other: Premier received funding from Biogen to conduct the study. Prasad:MCPHS University: Employment; Biogen: Other: Contracted employment with MCPHS University. Gayle:Premier, Inc.: Employment, Equity Ownership, Other: Premier received funding from Biogen to conduct the study. Kendter:Biogen: Employment. Hall:Biogen: Employment.

How to achieve full prophylaxis in young boys with severe haemophilia A: different regimens and their effect on early bleeding and venous access.

To facilitate early prophylaxis, step-up regimens starting prophylaxis with infusions 1×week(-1) were introduced. Choice of initial regimen may affect outcome. This study aims to classify initial prophylactic regimens and compare them on short-term outcome. From the 'European Paediatric Network for Haemophilia Management' (PedNet) registry, patients with severe haemophilia A without inhibitors, born 2000-2012, receiving prophylaxis were included. Treatment centres were classified according to the initial frequency of prophylactic infusions and the age at reaching infusions ≥3×week(-1) . Bleeding, and central venous access device (CVAD) use were compared at age 4years. In 21 centres with 363 patients, three regimens were identified: (i) start prophylaxis with ≥3×week(-1) infusions before age three (full: 19% of centres, 18% of patients); (ii) start 1-2×week(-1) , increasing frequency as soon as possible (asap), reaching ≥3×week(-1) before age three (43% of centres, 36% of patients); (iii) start 1-2×week(-1) , increasing frequency according to bleeding (phenotype), reaching ≥3×week(-1) after age three (38% of centres, 46% of patients). Prophylaxis was started at median 1.2years on the full and asap regimen vs 1.8years on the phenotype regimen. Complete prevention of joint bleeds was most effective on the full regimen (32% full vs. 27% asap and 8% phenotype), though at the cost of using most CVADs (88% full vs. 34% asap and 22% phenotype). The three prophylaxis regimens identified had different effects on early bleeding and CVAD use. This classification provides the first step towards establishing the optimum prophylactic regimen.

Single institutional experience of prevalence and risk factors of thromboembolic events in children with solid tumors

Children with cancer are long-term survivors and sequelae from thromboembolic events (TEEs) that include postthrombotic syndrome can cause significant morbidity. Prevalence and risk factors in children with solid tumors are not well described despite some recent studies. If risk factors were better defined, it may be possible to institute appropriate strategies to prevent TEEs and sequelae. A single institution study was performed to investigate the prevalence and risk factors of TEEs in pediatric solid tumors; this included a retrospective analysis of children with central nervous system (CNS) and non-CNS solid tumors with and without TEEs. TEEs were observed in 7.16% of analyzed tumors, higher in the non-CNS (10.6%) than in the CNS tumor category (1.9% P <0.0066). Factors associated with significant risk of TEEs are as follows: presence of a mediastinal mass (P = 0.0005), metastatic disease (P = 0.0086), infection (0.0120), central venous access device (CVAD) (P = 0.0167), and steroids as chemotherapy (P = 0.01). In patients with CVADs, a mediastinal mass (P = 0.0024) and the type of CVAD (peripherally inserted central catheters were more significant risk factors compared with Mediport; P < 0.0001) were significant risk factors. There was a 3.5-fold increased risk of TEEs in patients with CVADs with an underlying diagnosis of lymphoma vs. CNS tumors. Patients with non-CNS solid tumors had increased prevalence of TEEs in our study. Risk factors included metastatic disease, presence of a mediastinal mass, CVAD use, infection, and the use of steroids. Our study underscores the need to conduct a prospective study to formulate the use of prophylactic anticoagulation in patients with identified risk factors to prevent TEEs.

Focus on peripherally inserted central catheters in critically ill patients.

Venous access devices are of pivotal importance for an increasing number of critically ill patients in a variety of disease states and in a variety of clinical settings (emergency, intensive care, surgery) and for different purposes (fluids or drugs infusions, parenteral nutrition, antibiotic therapy, hemodynamic monitoring, procedures of dialysis/apheresis). However, healthcare professionals are commonly worried about the possible consequences that may result using a central venous access device (CVAD) (mainly, bloodstream infections and thrombosis), both peripherally inserted central catheters (PICCs) and centrally inserted central catheters (CICCs). This review aims to discuss indications, insertion techniques, and care of PICCs in critically ill patients. PICCs have many advantages over standard CICCs. First of all, their insertion is easy and safe -due to their placement into peripheral veins of the arm- and the advantage of a central location of catheter tip suitable for all osmolarity and pH solutions. Using the ultrasound-guidance for the PICC insertion, the risk of hemothorax and pneumothorax can be avoided, as well as the possibility of primary malposition is very low. PICC placement is also appropriate to avoid post-procedural hemorrhage in patients with an abnormal coagulative state who need a CVAD. Some limits previously ascribed to PICCs (i.e., low flow rates, difficult central venous pressure monitoring, lack of safety for radio-diagnostic procedures, single-lumen) have delayed their start up in the intensive care units as common practice. Though, the recent development of power-injectable PICCs overcomes these technical limitations and PICCs have started to spread in critical care settings. Two important take-home messages may be drawn from this review. First, the incidence of complications varies depending on venous accesses and healthcare professionals should be aware of the different clinical performance as well as of the different risks associated with each type of CVAD (CICCs or PICCs). Second, an inappropriate CVAD choice and, particularly, an inadequate insertion technique are relevant-and often not recognized-potential risk factors for complications in critically ill patients. We strongly believe that all healthcare professionals involved in the choice, insertion or management of CVADs in critically ill patients should know all potential risk factors of complications. This knowledge may minimize complications and guarantee longevity to the CVAD optimizing the risk/benefit ratio of CVAD insertion and use. Proper management of CVADs in critical care saves lines and lives. Much evidence from the medical literature and from the clinical practice supports our belief that, compared to CICCs, the so-called power-injectable peripherally inserted central catheters are a good alternative choice in critical care.

Central venous access device‐related infections in patients with haemophilia

Fully implantable central venous access devices (CVADs) can offer long-term reliable venous access to facilitate regular factor replacement therapy in haemophilia. However, CVAD-related infection remains a major deterrent to the optimal use of CVAD in this population. This report represents the first review of CVAD use in haemophilia in Australia and aims to examine the rate of complications including CVAD-related infections. A retrospective review of medical records was conducted of all haemophilic patients with fully implantable CVADs at the Royal Children's Hospital (RCH), Melbourne, between 1 June 1992 and 30 June 2009. CVAD-related bloodstream infection was defined based on the guidelines from the Centre of Disease Control and Victoria National Nosocomial Infection Surveillance. To further enhance identification of CVAD-related infection in this study, a third criterion of 'suspected infection' was added by the authors. Eighty-one CVADs in 56 patients were managed at the RCH during this time period resulting in a combined study period of 94 756 CVAD days. Median age at first CVAD insertion = 2.16 years (range 0.66 to 13.98 years). CVADs were inserted predominantly due to difficult venous access and prophylaxis initiation (70.4%). Median life-span of a CVAD was 1227 days, equivalent to 3.36 years (n = 50; range 0.22 to 9.44 years). Fifty-seven CVAD-related infections occurred in 37 CVADs (46.3%) in 29 patients (51.8%). Overall incidence of confirmed CVAD-related bloodstream infection = 0.42 per 1000 CVAD days (95% confidence interval (CI): 0.31 to 0.58 per 1000 CVAD days) and indicate better performance compared with the published benchmark of 0.66 per 1000 CVAD days (0.44 to 0.97 per 1000 CVAD days). The incidence of both confirmed (criteria 1, 2) and suspected (criterion 3) CVAD-related infection is 0.60 per 1000 CVAD days (95% CI: 0.46 to 0.78), which is comparable to the international benchmark. The majority of CVAD-related infections (73.7%) were successfully treated with intravenous antimicrobials without necessitating CVAD removal. Klebsiella pneumoniae was the most common organism found in positive blood cultures. CVAD-related infection in this Australian population was comparable to rates described in the medical literature. Ongoing surveillance for infection rates is important to provide an up-to-date assessment of risks associated with CVAD use in this population.

Challenges in the Management of Pediatric Central Venous Access Devices in the Community

Central venous access devices (CVADs) play an essential role in the care of critically ill children. Significant challenges exist for teams in managing CVADs particularly in a community setting. The authors aimed to assess the experience of general practitioners (GPs) caring for children with CVADs. From 200 CVADs inserted in a pediatric hospital in 2009, 50 patients were randomly selected and 44 GPs were forwarded a questionnaire. Twenty (46%) GPs responded. The main reasons (n = 22) for using CVADs were medication administration (n = 11), nutrition (n = 6), and blood sampling (n = 5). Thirteen (65%) GPs had no education in CVAD management and 14 (70%) were unaware of existing guidelines. Those identified by GPs as having primary responsibility for care of CVADs in the community included hospital/pediatric teams (n = 9), parents (n = 3), GPs (n = 2), public health nurses (n = 1), and palliative care (“home care”) teams (n = 1). The main challenges (n = 15) identified by GPs were lack of education (n = 4), line management difficulties (n = 3), infection risk (n = 3), infrequent exposure to CVADs (n = 3), and poor communication (n = 1). GPs felt that these challenges could be addressed through: education (n = 8), increased manpower and community support (n = 1), and improved communication (n = 1). This study highlights the inconsistency and challenges for GPs surrounding CVAD use in children. Further education and support is necessary to assist GPs in their use particularly when providing end-of-life care for children in the community.

Thrombotic adverse events to coagulation factor concentrates for treatment of patients with haemophilia and von Willebrand disease: a systematic review of prospective studies

Thrombotic adverse events (AEs) after clotting factor concentrate administration are rare but the actual rate is unknown. A systematic review of prospective studies (1990-2011) reporting safety data of factor concentrates in patients with haemophilia A (HA), haemophilia B (HB) and von Willebrand disease (VWD) was conducted to identify the incidence and type of thrombotic AEs. In 71 studies (45 in HA, 15 HB, 11 VWD) enrolling 5528 patients treated with 27 different concentrates (20 plasma-derived, 7 recombinant), 20 thrombotic AEs (2 HA, 11 HB, 7 VWD) were reported, including two major venous thromboembolic episodes (both in VWD patients on prolonged replacement for surgery). The remaining thrombotic AEs were superficial thrombophlebitis, mostly occurring at infusion sites in surgical patients and/or during concentrate continuous infusion. The overall prevalence was 3.6 per 10(3) patients (3.6 per 10(4) for severe AEs) and 1.13 per 10(5) infusions, with higher figures in VWD than in haemophilia. Thrombotic AEs accounted for 1.9% of non-inhibitor-related AEs. Thrombosis-related complications occurred in 10.8% of patients with central venous access devices (CVADs) reported in six studies, the risk increasing with time of CVAD use. Data from prospective studies over the last 20 years suggest that the risk of thrombotic AEs from factor concentrate administration is small and mainly represented by superficial thrombophlebitis. These findings support the high degree of safety of products currently used for replacement treatment.

Epidemiology and natural history of central venous access device (CVAD) use and infusion pump performance among patients (pts) treated for metastatic colorectal cancer (mCRC): Analysis from the NO16966 trial.

e14010 Background: A paucity of data on the natural history of CVADs in solid tumor pts, including mCRC, exists in the literature. CVAD use is associated with frequent and serious adverse events (AEs) in pts with hematologic malignancies, often occurring early (3-4 months after placement). Here we report the largest prospective evaluation of CVAD use and associated outcomes in mCRC. Methods: The NO16966 study employed a 2x2, placebo-controlled design. Pts without prior treatment for mCRC were randomized to receive infusional 5-FU/LV plus oxaliplatin (FOLFOX4) or capecitabine plus oxaliplatin (XELOX) and placebo or bevacizumab. Data were prospectively collected regarding CVAD placement/removal/replacement, associated AEs, pump malfunctions, and adherence to oral capecitabine. Analyses were descriptive; no formal statistical tests were performed. Results: CVAD placement data were available for 1341/1998 (67%) pts. Overall, 1194 pts had CVADs placed (FOLFOX4: n=797; XELOX: n=397) at baseline. Fewer XELOX pts required removal/replacement (8.8% vs 19.3%). Median time to first replacement was shorter with FOLFOX4 (133 days [95% CI: 105-155] vs 170 days [90-365]). Associated AEs were more frequent with FOLFOX4 (11.5% vs 2.4%), as were chronic AEs (7-9% vs 1-3%) with similar trends for infection and administration site AEs. Pump type used was split evenly across cycles (programmable vs single use). Malfunctions during fluoropyrimidine infusion occurred in 16% of FOLFOX4 pts, mostly with single use pumps. Pts treated with oral capecitabine showed high levels of adherence. Conclusions: CVAD-associated complications, need for replacement and pump malfunctions during treatment were common. XELOX-treated pts required fewer placements/replacements and experienced fewer associated AEs. Oral fluoropyrimidine regimens could reduce CVAD use and associated complications in the front-line treatment of mCRC. These observations may be relevant to the adjuvant setting as most events occur soon after placement. As adjuvant therapy is curative, any risk of potentially serious complications should be minimized.