Central Venous Access Device Placement Research Articles

An international expert consensus on improving the quality of care in patients with cancer by optimal central vascular access device selection.

e23233 Background: In cancer patients (CPs), selection of an appropriate venous access is critical not only for delivering effective treatment, but also for enhancing patient comfort and quality of life to ensure treatment continuity. This consensus provides recommendations on the selection of the most appropriate central venous access device (CVAD) and its management in CPs. Methods: Eleven experts from three continents, including oncologists and healthcare professionals (HCPs) skilled in CVAD placement & maintenance, convened electronically and face-to-face at a 2-day meeting. A comprehensive review of clinical trials & guidelines on CVADs published between January 2013 and December 2023 from PubMed & Cochrane Library was conducted. Preliminarily drafted statements were discussed by the panel and voted on. Evidence and panelists' expertise was employed in an anonymous polling for consensus. The final recommendations were approved by all panelists. Results: A summary of the panel’s consensus (ten statements) is shown in Table 1. Conclusions: The present consensus provides a robust clinical framework for HCPs to select the most suitable CVAD to facilitate therapy for CPs. [Table: see text]

The Effectiveness of Pediatric Central Venous Access Device Surveillance and Rounding Team: A Single-Center Study.

Introduction Central venous access devices (CVADs) are indispensable in the management of pediatric cancer patients, offering vital access to treatment. Yet, complications related to CVADs, such as infections, thrombosis, and dislocations, pose significant risks, potentially leading to prolonged hospitalization, intensive care unit admission, or even mortality. To address these challenges, our hospital established a pediatric CVAD surveillance and rounding team to improve the management and care of pediatric patients with CVADs. Materials and methods This single-center retrospective study evaluated the impact of the pediatric CVAD surveillance and rounding team on the management of pediatric oncology patients with CVADs at Kurashiki Central Hospital, Kurashiki, Japan. We included pediatric cancer patients under 18 years of age who underwent CVAD placement from January 2018 to December 2022. The team conducted weekly rounds focusing on a comprehensive checklist to ensure optimal CVAD care. We compared the incidence of catheter-related complications before and after the establishment of the rounding team using the Student's t-test and Fisher's exact test. Results The study encompassed 28 patients before and 39 after the implementation of the surveillance rounds. Significant reductions were observed in the number of dislocations (from 28.6% to 0%, p = 0.001) and local infections (from 17.9% to 2.6%, p = 0.04). While the decreases in thrombosis, catheter breakage/rupture, and catheter-related bloodstream infections (CRBSIs) did not reach statistical significance, they suggest a favorable trend toward enhanced management of CVADs. Conclusions The establishment of a pediatric CVAD surveillance and rounding team significantly reduced the incidence of dislocations and local infections among pediatric cancer patients with CVADs. This multidisciplinary team approach highlights the importance of continuous surveillance, teamwork, and education in enhancing the quality of CVAD care, contributing to safer patient outcomes and emphasizing the need for continuous improvement in pediatric CVAD management.

Pacemaker leads as a potential source of problems in patients who might need a central venous access port.

Lead-dependent venous occlusion may impede the insertion of a central venous access device (CVAD). The aim of this retrospective, cohort study was to assess the chance of implantation of CVAD in patients with cardiac implantable electronic devices (CIEDs). We reviewed and analyzed 3,075 venograms of patients with CIEDs undergoing transvenous lead extraction (TLE) between June 2008 and July 2021. Relationship between venous patency and the chance of CVAD placement was estimated. In 2,318 (75.38%) patients, venography showed no potential obstacles to venous port implantation on the ipsilateral side. In patients with leads on the left side, significant narrowing more often affected the subclavian vein than the brachiocephalic vein [1,595 (55.29%) vs. 830 (28.63%), respectively] or the superior vena cava (SVC) [21 (0.73%) cases]. Furthermore, the subclavian and brachiocephalic veins on the opposite side were also narrowed [35 (2.35%) and 27 (1.24%), respectively]. The chances of port insertion were assessed as easy on CIED side or opposite side in 2,318 (75.38%) and 2,291 (97.91%) patients, respectively), as difficult insertion/questionable performance in 246 (8.00%) and 22 (0.94% patients) and doubtful or impossible insertion/questionable performance in 511 (16.62%)/27 (1.15%) patients with CIED. (I) Varying degrees of lead-dependent venous obstruction (LDVO) is a frequent finding in patients with CIEDs; (II) the major thoracic veins on the opposite side of the chest may also be significantly narrowed; (III) venography should be considered before attempted CVAD insertion in patients with long lead dwell times or in patients after CIED removal, including planned contralateral port placement.

Association of Prophylactic Antibiotics With Early Infectious Complications in Children With Cancer Undergoing Central Venous Access Device Placement.

To evaluate the impact of prophylactic antibiotics on early infectious complications after central venous access device (VAD) placement in children with cancer. Despite the frequency of VAD procedures in children, the effectiveness of prophylactic antibiotics for reducing infectious complications is unknown. This was a retrospective cohort study of children with cancer undergoing central VAD placement identified in the Pediatric Health Information System database between 2017-2021. The primary outcome was the rate of early infectious complications (composite surgical site infections, central line-associated bloodstream infections, and bacteremia). Multivariable logistic regression was used to evaluate factors associated with early infection, and heterogeneity of treatment effect of prophylactic antibiotics was compared across subgroups. 9,216 patients were included (6,058 ports and 3,158 tunneled lines). Prophylactic antibiotics were associated with lower early infectious complications overall (1.3% vs. 2.4%; OR 0.55 [95% C.I. 0.39-0.79], P<0.001), an effect demonstrated for tunneled lines (OR 0.59, 95% C.I.: 0.41-0.84) but not ports (OR 3.01, 95% C.I.: 0.66-13.78). On multivariate analysis, prophylactic antibiotics (OR 0.67, 95% C.I.: 0.45-0.97) and solid tumors (OR 0.38, 95% C.I.: 0.22-0.64) were associated with reduced odds of early infections, while tunneled lines (OR 20.78, 95% C.I.: 9.83-43.93) and acute myelogenous leukemia (OR 2.37, 95% C.I.: 1.58-3.57) had increased odds. Prophylactic antibiotics are associated with reduced early infectious complications after central VAD placement overall. Despite recommendations from multiple national organizations against prophylactic antibiotics, these findings suggest a benefit in children with malignancy undergoing tunneled line placement.

Risk factors and predictors of adverse outcomes of in paediatric febrile neutropenia

Background: Febrile neutropenia (FN) is the commonest acute complication of cancer treatment in children. The identification of patients at risk for FN as well as adverse outcomes has been described.Aim: To evaluate the prevalence and potential risk factors for FN and describe adverse outcomes in a cohort of children treated for cancer.Setting: The study was carried out in a paediatric oncology unit in a children’s hospital, Cape Town, South Africa.Methods: A retrospective study from 01 January 2017 to 31 December 2019 on children with cancer at Red Cross War Memorial Children’s Hospital, Cape Town, South Africa.Results: Two hundred and sixty-seven episodes of FN occurred in 179 patients. Independent predictors of FN were acute myeloid leukaemia (AML) (p = 0.039), acute lymphocytic leukaemia (ALL) (p = 0.020) and intensive chemotherapy (p ≤ 0.001). Mucositis (p = 0.001), central venous access device (CVAD) placement (p = 0.004), haematologic malignancies (p = 0.040), blood transfusion during FN episode (p 0.001) and severe neutropenia (white cell counts 0.3 × 109 cells/L) (p ≤ 0.001) were risk factors for adverse outcomes. The mortality rate from FN was 3.57%. Independent predictors of adverse outcomes in those with FN were AML (p = 0.001), CVAD placement (p = 0.019) and severe neutropenia (p = 0.005).Conclusion: Treatment related adverse outcomes following chemotherapy-induced FN are likely in children with AML, severe neutropenia and with CVAD placement.Contribution: Adverse outcomes from paediatric febrile neutropenia is high. There is need for clinical decision making aimed at prevention and early identification of individuals at risk.

Surgical outcomes in people with hemophilia A taking emicizumab prophylaxis: experience from the HAVEN 1-4 studies

AbstractMany people with hemophilia A (PwHA) undergo surgery in their lifetime, often because of complications of their disease. Emicizumab is the first bispecific monoclonal antibody prophylactic therapy for PwHA, and its efficacy and safety have been previously demonstrated; however, there is a need to build an evidence base on the management of PwHA on emicizumab undergoing surgery. Data from the HAVEN 1-4 phase 3 clinical trials were pooled to provide a summary of all minor and major surgeries in PwHA with or without factor VIII (FVIII) inhibitors who were receiving emicizumab prophylaxis. Overall, 233 surgeries were carried out during the HAVEN 1-4 trials: 215 minor surgeries (including minor dental and joint procedures, central venous access device placement or removal, and endoscopies) in 115 PwHA (64 with FVIII inhibitors) and 18 major surgeries (including arthroplasty and synovectomy) in 18 PwHA (10 with FVIII inhibitors). Perioperative hemostatic support was at the discretion of the treating physician. Overall, the median (interquartile range [IQR]) age was 33.5 (13.0-49.0) years and the median (IQR) emicizumab exposure time before surgery was 278.0 (177.0-431.0) days. Among the 215 minor surgeries, 141 (65.6%) were managed without additional prophylactic factor concentrate, and of those, 121 (85.8%) were not associated with a postoperative bleed. The majority (15 of 18 [83.3%]) of major surgeries were managed with additional prophylactic factor concentrate. Twelve (80.0%) of these 15 surgeries were associated with no intraoperative or postoperative bleeds. The data demonstrate that minor and major surgeries can be performed safely in PwHA receiving emicizumab prophylaxis. These trials are registered at www.clinicaltrials.gov as #NCT02622321, #NCT02795767, #NCT02847637, and #NCT03020160.

A randomised trial of intracavitary electrocardiography versus surface landmark measurement for central venous access device placement

Background: Malpositioned central venous access devices (CVADs) can lead to significant patient injury including central vein thrombosis and dysrhythmias. Intra-cavitary electrocardiography (IC ECG) has been recommended by peak professional bodies as an accurate alternative for bedside CVAD insertion, to reduce risk of malposition and allowing immediate use of the device. Our objective was to compare the effect of IC ECG on CVAD malposition compared to traditional institutional practice for CVAD placement. Methods: Randomised controlled trial of IC ECG CVAD insertion verses traditional CVAD insertion (surface landmark measurement with post insertion x ray). Patient recruitment was from December 2016 to July 2018. The setting was a 900-bed tertiary referral hospital based in South Western Sydney, Australia. Three hundred and forty-four adult patients requiring CVAD insertion for intravenous therapy, were enrolled and randomly allocated (1:1 ratio) to either IC-ECG ( n = 172) or traditional ( n = 172) CVAD insertion. Our primary outcome of interest was the rate of catheters not requiring repositioning after insertion (ready for use). Secondary outcomes were comparison of procedure time and cost. Results: Of the 172 patients allocated to the IC ECG method, 170 (99%) were ready for use immediately compared to 139 of the 172 (81%) in the traditional insertion group (difference, 95% confidence interval (CI): 18%, 11.9–24.1%). The total procedure time was mean 15 min (SD 8 min) for IC ECG and mean 36 min (SD 17 min) for traditional CVAD insertion (difference–19.9 min (95% CI–14.6 to −34.4). IC ECG guided CVAD insertion had a cost reduction of AUD $62.00 per procedure. Conclusions: Using IC-ECG resulted in nearly no requirement for post-insertion repositioning of CVADs resulting in savings in time and cost and virtually eliminating the need for radiographic confirmation. Trial registration: This trial is registered at the Australian New Zealand Clinical Trials Registry ( http://www.anzctr.org.au ). The registration number is ACTRN12620000919910.

Comparison of perioperative practices for placement of central venous access devices (CVAD) in children with haemophilia

Abstract Background In children with haemophilia (CwH), central venous access devices (CVADs) are frequently placed to aid in the delivery of factor concentrates. In those who develop inhibitors, CVADs also allow for easy venous access and facilitation of immune tolerance therapy. Aim In this study, we compare perioperative practices for CVAD placement in children with haemophilia to assess similarities and differences in practices across centres in two countries (Singapore and Canada). Methods Retrospective chart review was conducted involving CwH (with and without inhibitors) who underwent CVAD placement from January 2007 to September 2017 at two centres in Singapore and at one centre in Hamilton, Canada. Data obtained included demographics, operative details, preoperative investigations, perioperative factor replacement, use of bypassing agents, antibiotic and antifibrinolytic use, length of stay, complications and need for CVAD revision. Results Twenty-one CwH were included in the data analysis. Amongst those without inhibitors, the mean preoperative factor dose was 50.0 IU/kg (SD=7.6) in Singapore, and 72.4 IU/kg (SD=12.5) in Hamilton (p=0.002); mean total factor use in the perioperative period was 425.0IU/kg (SD=114.9) in Singapore and 646.8IU/kg (SD=118.1) in Hamilton (p=0.004); mean duration of clotting factor replacement was 5.3 days (SD=0.9) in Singapore and 6.9 days (SD=0.7) in Hamilton (p=0.004). Amongst those with inhibitors, the mean preoperative dose of rFVIIa was 160.5 mcg/kg (SD=99.9) in Singapore and 88.2 mcg/kg (SD=3.8) in Hamilton (p=0.244); mean total rFVIIa used from surgery to discharge was 3,008.0 mcg/kg (SD=2305.9) in Singapore and 2,640.2 mcg/kg (SD=134.1) in Hamilton (p=0.842); mean duration of rFVIIa cover was 5.3 days (SD=1.7) in Singapore and 9.5 days (SD=2.1) in Hamilton (p=0.054). None of the CwH without inhibitors developed postoperative complications, compared to 57% in those with inhibitors (p=0.006). Conclusion Amongst CwH without inhibitors, significant variations were seen in perioperative factor replacement. Amongst those with inhibitors, there were also differences in perioperative practices across centres, although not statistically significant. Across centres, CwH with inhibitors were found to have more postoperative complications.

Analysis of six cancer patients with persistent left superior vena cava identified during central venous access device placement via an intracavitary electrocardiogram.

Persistent left superior vena cava (PLSVC) is a rare congenital anomaly. PLSVC can be associated with clinically significant atrial septal defect (ASD) or ventricular septal defect (VSD). It is usually asymptomatic and accidentally detected during invasive procedures or imaging examinations. However, whether central venous access device (CVAD) can be placed and used in patients with PLSVC is controversial. A total of six patients were diagnosed with PLSVC and confirmed by chest CT among 3391 cancer patients who underwent CVAD placement via intracavitary electrocardiogram (IC-EKG) at the Venous Access Center (VAC) from May 2019 to December 2020. The CVADs (peripherally inserted central catheter in four patients and Ports in two patients) of these six patients were left in PLSVC. We analyzed changes in the P-wave in the IC-EKG during CVAD placement and the characteristics of the body surface electrocardiogram in these patients and discussed the catheter tip position in PLSVC. All six patients showed negative P-waves in lead II via IC-EKG from the beginning of catheterization: four patients showed negative P-waves and two showed biphasic P-waves in the body surface electrocardiogram (lead III) before catheterization. CVAD function was normal and no obvious complications were observed during the treatment of these patients. The total retention time of CVADs was 1537 days. For patients with a negative P-wave in lead II via IC-EKG during catheterization, especially in those with a negative or biphasic P-wave in lead III of the body surface electrocardiogram, PLSVC should be considered. CVAD insertion in patients with type I PLSVC is safe under certain conditions, with the proper tip position in the middle to lower part of PLSVC.

Outcomes of Pediatric Central Venous Access Device Placement With Concomitant Surgical Procedures

BackgroundChildren frequently undergo placement of a tunneled central venous catheter or port (CVAD) concomitantly with other surgical procedures (CVAD-CP), but the risk factors for early CVAD complications with this practice are unclear. MethodsChildren undergoing CVAD-CP were identified from the National Surgical Quality Improvement Program-Pediatric 2012-2016 database. Predictor variables included demographics, CP characteristics, malignancy, and CVAD type. Outcome variables were CVAD-associated bloodstream infection (CLABSI) or new deep venous thrombosis (nDVT) within 30 d. Patients with and without CLABSI or nDVT were compared, and the temporal relationship of nDVT and CLABSI was investigated. Multivariable logistic regression modeling was used to assess independent risk factors for CLABSI. ResultsOf 2036 patients included, median age was 1.5 y, 35% had malignancy, and 40% had a clean concomitant procedure. Overall, 1.3% developed CLABSI and 0.7% developed nDVT. Multivariable regression modeling revealed higher risk of CLABSI with clean CPs (odds ratio [OR] 2.4, 95% confidence interval [CI] 1.06-5.34, P = 0.035), tunneled catheters (OR 3.2, 95% CI 1.18-8.56, P = 0.022), and longer anesthesia duration (OR 1.02 per 10 min, 95% CI 1.00-1.04, P = 0.042). nDVT was strongly associated with CLABSI (21% CLABSI among those with DVT, 0.5% among those without, P ≤ 0.0001). In all cases of nDVT with CLABSI, the diagnosis of DVT preceded diagnosis of CLABSI, by a median of 7 d. ConclusionsThe type of CVAD and characteristics of the concomitant procedure influence early CLABSI after CVAD-CP. The unexpected finding of higher CLABSI rates among clean concomitant procedures suggests that perioperative prophylactic antibiotics should not be withheld in this setting, but requires prospective validation. nDVT is frequently diagnosed prior to CLABSI, suggesting a possible role for antibiotics in the treatment of postoperative DVT after CVAD placement.

Central Line-Associated Thrombus Formation in an Inhibitor Negative Severe Hemophilia A Patient on Emicizumab

Introduction: The main goal of Hemophilia A treatment has been to restore secondary hemostasis, whether through direct factor VIII replacement or through a combination of bypassing agents and immune tolerance induction in cases of inhibitor activity. In pediatric populations, these treatments are frequently given through a central venous access device (CVAD) for ease of access, convenience, and mitigation of pain. However, these devices carry the risk of infection and thromboembolism (Cost &amp; Journeycake, 2011). The new Hemophilia treatment emicizumab (Hemlibra) has the benefits of less frequent dosing (weekly to every 4 weeks) and does not require central venous access since it is given subcutaneously. There have been cases in the literature of patients developing thromboemboli when using both emicizumab and high doses of inhibitor bypassing agents such as activated prothrombin complex concentrate (aPCC) (Weyand, Dorfman, Shavit, &amp; Pipe, 2019). There have been no reported cases of patients developing thromboemboli who were on emicizumab alone. We present a patient with severe Hemophilia A with no inhibitor who developed a central line-associated venous thromboembolism (VTE) while on emicizumab. Case Summary: A nine-year-old boy with Hemophilia A, factor VIII activity &lt;1%, and no known inhibitor was managed for several years with prophylactic recombinant antihemophilic factor VIII (Advate). A left subclavian CVAD was placed at 15 months of age. A fluoroscopic port study revealed retrograde infusion secondary to a fibrin sheath at the tip of the catheter when the patient was three years old. A right subclavian CVAD was subsequently placed. At the age of seven, the patient's right subclavian port also developed a fibrin sheath. This was removed and multiple attempts to access the subclavian vein again were unsuccessful, leading to right femoral CVAD placement. Two years later, the patient was transitioned to emicizumab. His last dose of recombinant factor VIII was two weeks after initiation of emicizumab. Emicizumab loading doses were completed, and the patient continued with every 28-day dosing. Line removal was scheduled for summer months for the family's convenience. Three months after starting emicizumab, the patient experienced right ankle pain and leg swelling. Venous ultrasound revealed an acute on chronic VTE in the right distal external iliac vein. The patient had not received any aPCC prior to or during emicizumab therapy. Management: The femoral CVAD was removed, and the patient received two doses of recombinant factor VIII during the admission. The patient was started on enoxaparin titrated to a therapeutic anti-Xa level while continuing emicizumab. At approximately one month of follow up, the venous ultrasound showed resolution of the acute portion of his VTE and persistence of chronic VTE. Thereafter, patient was to continue eight more weeks of enoxaparin prior to further venous ultrasound imaging. This patient's family then moved, and the patient was transferred to another hemophilia treatment center. Conclusions: Patients with central venous catheters on emicizumab alone without may develop clinically significant thromboemboli. We propose that guidelines should be developed for patients with CVAD receiving emicizumab. Patients transitioned to emicizumab with central lines in place may require more urgent removal. Furthermore, standardized therapy for anticoagulation is needed for patients on emicizumab who develop VTE.

Is There a Role for Thromboprophylaxis in Sickle Cell Patients with Central Venous Access Devices?

Introduction: Chronic transfusion is a therapeutic modality in the prevention and treatment of end-organ damage in sickle cell disease (SCD) patients. Central venous access devices (CVAD) are commonly used in many SCD patients due to poor venous access. However, CVAD is a known risk factor for venous thromboembolism (VTE) (Evans et al, 2010), with right atrial thrombi prevalence estimated between 5.4 and 12.5% (Shah et al., 2004; Gilon et al., 1998). Although SCD is a prothrombotic state (Wun et al, 2013), it is not known whether this risk factor interacts with CVADs in a synergistic manner to increase the overall risk of VTE. No study has specifically addressed the role of thromboprophylaxis for CVAD-related VTEs in SCD, and as such the practice of prophylactic anticoagulation and/or antiplatelet therapy for CVAD is heterogeneous. We therefore conducted a quality improvement study to investigate whether thromboprophylaxis is a protective factor for new catheter-related thrombi (CRT).Methods: By cross-referencing imaging, thrombosis clinic, and sickle cell clinic databases, we identified adult SCD patients (≥ 18) of all genotypes followed within the Toronto General Hospital SCD center between January 1, 2009 and December 31, 2017 who had a CVAD intended for long-term use (≥3 months). CRT was defined as a VTE that developed while the CVAD was in place. Patients with no VTE during CVAD placement were assigned to the comparator group. Patients who were on anticoagulation for any alternative reason prior to CVAD insertion were excluded. The presence, type, and intensity of pharmacological thromboprophylaxis at the time of CRT or line insertion were recorded. Patient, catheter, and treatment-related risk factors of VTE were extracted from electronic patient records. Fisher-exact and chi-square tests were conducted to explore possible associations between categorical co-variates, and thromboprophylaxis use. Linear regression was performed for continuous variables; while binary logistic regression was conducted to examine the potential association between thromboprophylaxis use and CRT, while adjusting for sex, genotype, hydroxyurea use, and concomitant thrombosis risk factors.Results: We identified 52 unique patients from 3 databases. After applying the inclusion and exclusion criteria, 25 patients were retained as stated in Figure 1-CONSORT Flow Diagram. Patient characteristics are summarized in Table 1-Patient Demographics and Characteristics. Events were distributed as follows: 3 deep venous thrombi, 1 superficial venous thrombus, 1 pulmonary emboli, 2 right atrial thrombi, and 2 thrombi from other sites. Patients with CRT incurred significant sequelae, including open heart surgery to remove the clot in the two patients with right atrial thrombi. Univariate analysis illustrated association between the development of a CRT and the use of thromboprophylaxis, type of thromboprophylaxis, and dose intensity (p=0.011, p=0.011 and p=0.017, respectively). HU use showed a trend towards lower risk for CRT (OR 0.129, p=0.061). However, CRT was not associated with gender, genotype, type, site of insertion, year of insertion, duration of insertion, indication for CVAD, BMI, or ferritin. Association between CVAD thromboprophylaxis and CRT remained significant despite adjusting for sex, genotype, HU and concomitant thrombosis risk factors in binary logistic regression (p=0.032). Patients who received pharmacologic thromboprophylaxis for CVAD were 30.9 times less likely to have a CRT. Due to the limited sample size, not all variables could be included in the logistic regression.Conclusion: The presence of a CVAD is a significant risk factor for VTE in SCD patients. The retrospective study demonstrated that CRTs are associated with the absence of pharmacological thromboprophylaxis for CVADs. In addition, the potential role of HU in reducing thromboembolic risk in SCD patients with CVADs, requires further exploration. Finally, in the event that a CVAD is unavoidable we recommend consideration of pharmacologic thromboprophylaxis, in order to reduce patient morbidity and health-care associated costs. [Display omitted] DisclosuresForté:Novartis: Honoraria.

Concurrent Central Venous Stent and Central Venous Access Device Placement Does Not Compromise Stent Patency or Catheter Function in Patients with Malignant Central Venous Obstruction

PurposeTo determine if concurrent placement of a central venous stent (CVS) and central venous access device (CVAD) compromises stent patency or catheter function in patients with malignant central venous obstruction. Materials and MethodsCVS placement for symptomatic stenosis resulting from malignant compression was performed in 33 consecutive patients who were identified retrospectively over a 10-year period; 28 (85%) patients had superior vena cava syndrome, and 5 (15%) had arm swelling. Of patients, 11 (33%) underwent concurrent CVS and CVAD placement, exchange, or repositioning; 22 (67%) underwent CVS deployment alone and served as the control group. Types of CVADs ranged from 5-F to 9.5-F catheters. Endpoints were CVS patency as determined by clinical symptoms or CT and CVAD function, which was determined by clinical performance. ResultsAll procedures were technically successful. There was no difference between the 2 groups in clinically symptomatic CVS occlusion (P = .2) or asymptomatic in-stent stenosis detected on CT (P = .5). None of the patients in the CVS and CVAD group had recurrent clinical symptoms, but 3 (30%) of 10 patients with imaging follow-up had asymptomatic in-stent stenosis. In the control group, 3 (14%) patients had clinically symptomatic CVS occlusion and required stent revision, whereas 4 (21%) of 19 patients with imaging follow-up had asymptomatic in-stent stenosis. During the study, 2 (20%) functional but radiographically malpositioned catheters were identified (0.66 per 1,000 catheter days). ConclusionsPresence of a CVAD through a CVS may not compromise stent patency or catheter function compared with CVS placement alone.

Complications of haemophilia in babies (first two years of life): a report from the Centers for Disease Control and Prevention Universal Data Collection System.

To describe the prevalence and complications in babies ≤2 years with haemophilia. We used a standardized collection tool to obtain consented data on eligible babies aged ≤2 years with haemophilia enrolled in the Centers for Disease Control and Prevention Universal Data Collection System surveillance project at US Hemophilia Treatment Centers (HTCs). Of 547 babies, 82% had haemophilia A, and 70% were diagnosed within one month of birth. Diagnosis was prompted by known maternal carrier status (40%), positive family history (23%), bleeding (35%) and unknown 2%; 81% bled during the first two years. The most common events were bleeding (circumcision, soft tissue, oral bleeding) and head injury. There were 46 episodes of intracranial haemorrhage (ICH) in 37 babies (7%): 18 spontaneous, 14 delivery related, 11 traumatic, 2 procedure related and 1 unknown cause. Of the 176 central venous access devices (CVADs) in 148 (27%) babies, there were 137 ports, 22 surgically inserted central catheters and 20 peripherally inserted central catheters. Ports had the lowest complication rates. Inhibitors occurred in 109 (20%) babies who experienced higher rates of ICH (14% vs. 5%; P = 0.002), CVAD placement (61% vs. 19%; P < 0.001) and CVAD complications (44% vs. 26%; P < 0.001). The most common replacement therapy was recombinant clotting factor concentrates. Bleeding events in haemophilic babies ≤2 years were common; no detectable difference in the rates of ICH by the mode of delivery was noted. Neonatal factor exposure did not affect the inhibitor rates. Minor head trauma, soft tissue and oropharyngeal bleeding were the leading indications for treatment.

Central Venous Access: Evolving Roles of Radiology and Other Specialties Nationally Over Two Decades

The aim of this study was to evaluate national trends in central venous access (CVA) procedures over 2 decades with regard to changing specialty group roles and places of service. Aggregated claims data for temporary central venous catheter and long-term CVA device (CVAD) procedures were extracted from Medicare Physician/Supplier Procedure Summary Master Files from 1992 through 2011. Central venous catheter and CVAD procedure volumes by specialty group and place of service were studied. Between 1992 and 2011, temporary and long-term CVA placement procedures increased from 638,703 to 808,071 (+27%) and from 76,444 to 316,042 (+313%), respectively. For temporary central venous catheters, radiology (from 0.4% in 1992 to 32.6% in 2011) now exceeds anesthesiology (from 37% to 22%) and surgery (from 30.4% to 11.7%) as the dominant provider group. Surgery continues to dominate in placement and explantation of long-term CVADs (from 80.7% to 50.4% and from 81.6% to 47.7%, respectively), but radiology's share has grown enormously (from 0.7% to 37.6% and from 0.2% to 28.6%). Although volumes remain small (<10% of all procedures), midlevel practitioners have experienced >100-fold growth for most services. The inpatient hospital remains the dominant site for temporary CVA procedures (90.0% in 1992 and 81.2% in 2011), but the placement of long-term CVADs has shifted from the inpatient (from 68.9% to 45.2%) to hospital outpatient (from 26.9% to 44.3%) setting. In all hospital settings combined, radiologists place approximately half of all tunneled catheters and three-quarters all peripherally inserted central catheters. Over the past 2 decades, CVA procedures on Medicare beneficiaries have increased considerably. Radiology is now the dominant overall provider.

Diagnosis and treatment of factor VIII and IX inhibitors in congenital haemophilia: (4th edition)

Peter W. Collins, Elizabeth Chalmers, Daniel P. Hart, Ri Liesner, Savita Rangarajan, Kate Talks, Mike Williams and Charles R. Hay School of Medicine, Cardiff University, University Hospital of Wales, Wales, Royal Hospital for Sick Children, Glasgow, The London School of Medicine and Dentistry, Royal London Hospital, Barts, Queen Mary University, London, Great Ormond Street NHS Trust, London, Hampshire Hospital NHS Foundation Trust, Basingstoke & North Hampshire Hospital, Basingstoke, Royal Victoria Infirmary, Newcastle upon Tyne, Birmingham Childrens’ Hospital NHS Foundation Trust, Birmingham and Central Manchester University Hospitals, Manchester, UK

Persistent left superior vena cava: Review of the literature, clinical implications, and relevance of alterations in thoracic central venous anatomy as pertaining to the general principles of central venous access device placement and venography in cancer patients

Persistent left superior vena cava (PLSVC) represents the most common congenital venous anomaly of the thoracic systemic venous return, occurring in 0.3% to 0.5% of individuals in the general population, and in up to 12% of individuals with other documented congential heart abnormalities. In this regard, there is very little in the literature that specifically addresses the potential importance of the incidental finding of PLSVC to surgeons, interventional radiologists, and other physicians actively involved in central venous access device placement in cancer patients. In the current review, we have attempted to comprehensively evaluate the available literature regarding PLSVC. Additionally, we have discussed the clinical implications and relevance of such congenital aberrancies, as well as of treatment-induced or disease-induced alterations in the anatomy of the thoracic central venous system, as they pertain to the general principles of successful placement of central venous access devices in cancer patients. Specifically regarding PLSVC, it is critical to recognize its presence during attempted central venous access device placement and to fully characterize the pattern of cardiac venous return (i.e., to the right atrium or to the left atrium) in any patient suspected of PLSVC prior to initiation of use of their central venous access device.

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.

Implantable central venous access device procedures in haemophilia patients without an inhibitor: systematic review of the literature and institutional experience

Elective surgical procedures involving central venous access devices (CVADs) in patients with haemophilia are often necessary for adequate factor delivery but there are few data regarding haemostatic coverage and acute complication rates accompanying these procedures. To describe experience with CVAD insertion, revision and removal in young haemophilia patients at our institution and in the literature and to assess acute complications following CVAD procedures. PubMed, Medline and Cochrane databases were searched for articles, which included a description of factor coverage during CVAD procedures. A retrospective review of our comprehensive haemophilia database identified patients undergoing CVAD placement, revision and removal between January 1993 and August 2005. Manual and electronic searches of the published literature yielded 14 articles, which met inclusion criteria. Peri-operative factor administration varied greatly among the reports. Mean acute infection and haematoma rates were 8% and 12.5% respectively. A retrospective review identified 49 CVAD placements, revisions, or removals meeting inclusion criteria. Most patients received outpatient bolus factor replacement to achieve a level of 100% preoperatively, immediately postoperatively and on postoperative days 1, 2, 3, 5 and 7. Thirty-six procedures were performed without hospitalization. Ten patients developed 11 (22%) minor haematomas postoperatively. Major haemorrhage, acute infection, or pneumothorax was not encountered. Few published data exist regarding haemostatic coverage and complications following CVAD procedures. Our institutional experience using a consistent management approach was favourable. Further studies are required to define optimal haemostatic coverage during minor surgical procedures in haemophilia.

Eliminating the "Pitfalls" of chronic indwelling central venous access device placement in cancer patients by utilizing a venous cutdown approach and by selectively and appropriately utilizing intraoperative venography

There are several very obvious and simple solutions for eliminating the "Pitfalls" and for minimizing the risk of occurrence of any perioperative complications associated with placement of chronic indwelling central venous access devices in cancer patients. The first is the utilization of a venous cutdown approach, such as the cephalic vein or the external jugular vein, which essentially eliminates potentially life-threatening perioperative complications, such as pneumothorax and injury to the great vessels (with or without associated hemothorax). The second is the selective and appropriate utilization of intraoperative venography for defining the central venous anatomy and for providing a venous roadmap in those particularly challenging cases in which difficulties are encountered during chronic indwelling central venous access device placement.