Safety and efficacy of anticoagulant therapy in pediatric catheter-related venous thrombosis (EINSTEIN-Jr CVC-VTE)

Abstract Anticoagulant treatment of pediatric central venous catheter–related venous thromboembolism (CVC-VTE) has not been specifically evaluated. In EINSTEIN-Jr, 500 children with any VTE received rivaroxaban or standard anticoagulants. A predefined analysis of the CVC-VTE cohort was performed. Children with CVC-VTE (age, birth to 17 years) were administered rivaroxaban or standard anticoagulants during the 1-month (children <2 years) or 3-month (all other children) study period. Predefined outcomes were recurrent VTE, change in thrombotic burden on repeat imaging, and bleeding. Predictors for continuation of anticoagulant therapy beyond the study period were evaluated. One hundred twenty-six children with symptomatic (n = 76, 60%) or asymptomatic (n = 50, 40%) CVC-VTE received either rivaroxaban (n = 90) or standard anticoagulants (n = 36). There was no recurrent VTE (0%; 95% confidence interval [CI], 0.0%-2.8%). Three children had the principal safety outcome: none had major bleeding and 3 children had clinically relevant nonmajor bleeding (2.4%; 95% CI, 0.7%-6.5%), all in the rivaroxaban arm. Complete or partial vein recanalization occurred in 57 (55%) and 38 (37%) of 103 evaluable children, respectively. Results were similar for symptomatic and asymptomatic CVC-VTE. Continuation of anticoagulant therapy beyond the study period occurred in 61 (48%) of children and was associated with residual VTE but only in children <2 years (odds ratio [OR], 20.9; P = .003) and continued CVC use (OR, 6.7; P = .002). Anticoagulant therapy appeared safe and efficacious and was associated with reduced clot burden in most children with symptomatic or asymptomatic CVC-VTE. Residual VTE and continued CVC use were associated with extended anticoagulation. This trial was registered at www.clinicaltrials.gov as #NCT02234843.

Download Full-text

Duration of Anticoagulation Therapy for Venous Thromboembolism

Hematology ◽

10.1182/asheducation-2008.1.252 ◽

2008 ◽

Vol 2008 (1) ◽

pp. 252-258 ◽

Cited By ~ 18

Author(s):

Henri Bounameaux ◽

Arnaud Perrier

Keyword(s):

Venous Thromboembolism ◽

Anticoagulant Therapy ◽

Odds Ratio ◽

Vitamin K Antagonists ◽

Initial Period ◽

Anticoagulation Therapy ◽

Case Fatality ◽

Clinical Decision ◽

Venous Thromboembolic Event ◽

Anticoagulant Treatment

Abstract Treatment of acute deep vein thrombosis and pulmonary embolism-often denominated together as venous thromboembolism (VTE)- consists of parenteral administration of heparin (usually low-molecular-weight heparin or alternatively unfractionated heparin or fondaparinux) overlapped and followed by oral vitamin K antagonists that are administered for a certain period (usually 3 to 12 months). Recommended or suggested durations differ according to guidelines. Practically, the clinical decision in an individual patient depends upon the estimated risks of VTE recurrence and treatment-induced bleeding. The risk of VTE recurrence is higher in idiopathic events (about 10% per year during the first two years and 3% per year thereafter) (odds ratio of 2.4, compared to secondary events); in male subjects (at least before the age of 60, with an odds ratio of 2–4); in patients with persistently elevated D-dimer level (odds ratio of 2.3, compared with normal level); and during the first two years after discontinuation of treatment. The annual risk of major bleeding on anticoagulant treatment vary largely in observational studies with figures of 2% to 29%, depending on the patient characteristics. The case-fatality rate is 8% (DVT), 12% (PE) for recurrent VTE, and about 10% for major bleed. These figures do not support long-term anticoagulant therapy, except in those patients exhibiting a very high risk of recurrence and/or a very low risk of bleeding. New therapeutic aspects might impact on the duration of anticoagulant therapy after a venous thromboembolic event. They include the possibility of pursuing anticoagulant treatment at a reduced INR after an initial period with an INR 2-3, and the advent of new, more specific and orally active anticoagulants. These features might modify the risk-benefit balance of extending anticoagulant therapy beyond the usual, limited duration.

Download Full-text

Su1306 Central Venous Catheter Salvage in HPN Catheter-Related Blood Stream Infections Safety and Efficacy Data From a National Centre

Gastroenterology ◽

10.1016/s0016-5085(13)61673-x ◽

2013 ◽

Vol 144 (5) ◽

pp. S-453

Author(s):

Martyn Dibb ◽

Gordon Carlson ◽

Arun Abraham ◽

Paul Chadwick ◽

Jon Shaffer ◽

...

Keyword(s):

Central Venous Catheter ◽

Venous Catheter ◽

Blood Stream ◽

Central Venous ◽

Efficacy Data ◽

Blood Stream Infections ◽

Safety And Efficacy ◽

National Centre

Download Full-text

Two doses of rivaroxaban versus aspirin for prevention of recurrent venous thromboembolism

Thrombosis and Haemostasis ◽

10.1160/th15-02-0131 ◽

2015 ◽

Vol 114 (09) ◽

pp. 645-650 ◽

Cited By ~ 31

Author(s):

Rupert Bauersachs ◽

Jan Beyer-Westendorf ◽

Henri Bounameaux ◽

Timothy Brighton ◽

Alexander Cohen ◽

...

Keyword(s):

Venous Thromboembolism ◽

Anticoagulant Therapy ◽

Low Dose ◽

Double Blind ◽

Once Daily ◽

Safety Outcome ◽

Dose Aspirin ◽

Recurrent Venous Thromboembolism ◽

Low Dose Aspirin ◽

Recurrent Vte

SummaryPatients with unprovoked venous thromboembolism (VTE) are at high risk for recurrence. Although rivaroxaban is effective for extended VTE treatment at a dose of 20 mg once daily, use of the 10 mg dose may further improve its benefit-to-risk ratio. Low-dose aspirin also reduces rates of recurrent VTE, but has not been compared with anticoagulant therapy. The EINSTEIN CHOICE study is a multicentre, randomised, double-blind, active-controlled, event-driven study comparing the efficacy and safety of two once daily doses of rivaroxaban (20 and 10 mg) with aspirin (100 mg daily) for the prevention of recurrent VTE in patients who completed 6–12 months of anticoagulant therapy for their index acute VTE event. All treatments will be given for 12 months. The primary efficacy objective is to determine whether both doses of rivaroxaban are superior to aspirin for the prevention of symptomatic recurrent VTE, while the principal safety outcome is the incidence of major bleeding. The trial is anticipated to enrol 2,850 patients from 230 sites in 31 countries over a period of 27 months. In conclusion, the EINSTEIN CHOICE study will provide new insights into the optimal antithrombotic strategy for extended VTE treatment by comparing two doses of rivaroxaban with aspirin (clinicaltrials.gov NCT02064439).

Download Full-text

Surgically assisted trans-hepatic anterior approach for central venous catheter placement: Safety and efficacy

Journal of Pediatric Surgery ◽

10.1016/j.jpedsurg.2012.07.065 ◽

2012 ◽

Vol 47 (12) ◽

pp. 2353-2356 ◽

Cited By ~ 2

Author(s):

Antonella Diamanti ◽

Massimo Rollo ◽

Lidia Monti ◽

Manila Candusso ◽

Jean de Ville de Goyet

Keyword(s):

Central Venous Catheter ◽

Anterior Approach ◽

Venous Catheter ◽

Catheter Placement ◽

Central Venous ◽

Central Venous Catheter Placement ◽

Safety And Efficacy

Download Full-text

Use of Maximal Sterile Barrier Precautions and/or Antimicrobial-Coated Catheters to Reduce the Risk of Central Venous Catheter-Related Bloodstream Infection

Infection Control and Hospital Epidemiology ◽

10.1086/590356 ◽

2008 ◽

Vol 29 (10) ◽

pp. 947-950 ◽

Cited By ~ 25

Author(s):

Duk-hee Lee ◽

Koo Young Jung ◽

Yoon-Hee Choi

Keyword(s):

Multivariate Analysis ◽

Mortality Rate ◽

Central Venous Catheter ◽

Confidence Interval ◽

Bloodstream Infection ◽

Odds Ratio ◽

Venous Catheter ◽

Central Venous ◽

Factors Associated ◽

Catheter Related Bloodstream Infection

Central venous catheter-related bloodstream infection is clinically important because of its high mortality rate. This prospective study shows by multivariate analysis that the use of maximal sterile barrier precautions (odds ratio, 5.205 [95% confidence interval, 0.015-1.136]; P= .023) and the use of antimicrobial-coated catheters (odds ratio, 5.269 [95% confidence interval, 0.073-0.814]; P = .022) are independent factors associated with a lowered risk of acquiring a central venous catheter-related bloodstream infection.

Download Full-text

FDG embolism mimicking lung metastasis

Journal of Clinical Images and Medical Case Reports ◽

10.52768/2766-7820/1086 ◽

2021 ◽

Vol 2 (2) ◽

Author(s):

Amin Haghighat Jahromi ◽

◽

Carl K Hoh ◽

Keyword(s):

Central Venous Catheter ◽

Lung Metastasis ◽

Intravenous Administration ◽

Patient Management ◽

Venous Catheter ◽

Central Venous ◽

History Of ◽

Platelet Aggregates ◽

18F Fdg ◽

Repeat Imaging

2-[18F]-FDG embolism artifact is a PET pitfall that may cause misinterpretation as lung metastasis. This rare phenomenon results from clumping of the radiotracer with platelet aggregates during intravenous administration. It should be considered, especially if there is no corroborating anatomic correlate for focal pulmonary FDG activity and if the radiotracer is administered through a central venous catheter. Herein, we present images of a 3-year-old girl with history of abdominal neuroblastoma and lung metastasis, showing FDG embolism artifact, subsequently resolved in the repeat imaging. Our case reinforces the importance of knowing this artifact as misinterpretation can have a significant effect on patient management.

Download Full-text

Prevention of Recurrent Thrombotic Events in Children with Central Venous Catheter-Associated Venous Thrombosis

Blood ◽

10.1182/blood.2021013453 ◽

2021 ◽

Author(s):

Helen Havens Clark ◽

Lance Ballester ◽

Hilary B Whitworth ◽

Leslie Raffini ◽

Char Witmer

Keyword(s):

Risk Factors ◽

Significant Risk ◽

Venous Catheter ◽

Significant Risk Factor ◽

Bleeding Risk ◽

Secondary Prophylaxis ◽

Central Venous ◽

Full Dose ◽

Increased Risk ◽

Recurrent Vte

Central venous catheters (CVC) are the most significant risk factor for pediatric venous thromboembolism (VTE). After an index CVC-associated VTE (CVC-VTE), the role of secondary prophylaxis for subsequent CVC placement is uncertain. Aims of this single center retrospective study were to evaluate the efficacy of secondary prophylaxis for patients with a prior CVC-VTE and identify risk factors associated with recurrent VTE in patients less than 19 years with an index CVC-VTE between 2003 and 2013. Data collection included clinical and demographic factors, subsequent CVC placement, secondary prophylaxis strategy, recurrent VTE, and bleeding. Risk factors for recurrence and effectiveness of secondary prophylaxis were evaluated using survival and binomial models. Among 373 patients with an index CVC-VTE, 239 (64.1%) had subsequent CVC placement. 17.4% (65/373) of patients had recurrent VTE, 90.8% (59/65) were CVC-associated. On multivariable survival analysis, each additional CVC (HR 12.00; 95% CI 2.78 - 51.91), congenital heart disease (HR 3.70; 95% CI 1.97 - 6.95), and total parenteral nutrition dependence (HR 4.02; 95% CI 2.23 - 7.28) were associated with an increased hazard of recurrence. Full dose anticoagulation for secondary prophylaxis was associated with decreased odds of recurrent CVC-VTE (OR 0.35; 95% CI 0.19 - 0.65) but not prophylactic dosing (OR 0.61; 95% CI 0.28 - 1.30). Only 1.3% of CVCs experienced major bleeding with prophylactic or full dose anticoagulation. In summary, children with CVC-VTE are at increased risk for recurrent VTE. Secondary prophylaxis with full dose anticoagulation was associated with a 65% reduction in odds of thrombotic events.

Download Full-text

Maturing arteriovenous accesses in incident haemodialysis patients and first-year outcomes

The Journal of Vascular Access ◽

10.1177/1129729819874531 ◽

2019 ◽

Vol 21 (3) ◽

pp. 322-327

Author(s):

Rita L McGill ◽

Eduardo K Lacson

Keyword(s):

Central Venous Catheter ◽

Arteriovenous Fistula ◽

Odds Ratio ◽

Venous Catheter ◽

The United States ◽

First Year ◽

Central Venous ◽

Arteriovenous Fistulas ◽

Arteriovenous Access ◽

One Year

Introduction: Nephrologists have increased arteriovenous access placement in patients with chronic kidney disease. Not yet usable ‘maturing’ arteriovenous fistulas and grafts are nearly as common as mature arteriovenous fistulas or grafts. Little has been reported about patients initiating haemodialysis with unready arteriovenous fistulas or grafts. Methods: The United States Renal Data System records for all adult patients initiating haemodialysis with central venous catheters between July 2010 and December 2011. Patients were categorized by whether a maturing arteriovenous fistula or graft was present. Transition to working arteriovenous fistula or graft was determined from linked Medicare claims. Modality changes and survival were ascertained. A logistic model for one-year survival and a subdistribution hazards model for transition to working arteriovenous fistula or graft, accounting for the competing risk of death, were constructed. Results: Compared to central venous catheter-only, maturing arteriovenous fistula or graft was associated with access conversion (hazard ratio = 2.23 (2.17–2.30) and 3.25 (2.97–3.56), respectively, p < 0.001 for both). Median time to conversion, among those who transitioned, was 95 days (interquartile range = 56–139) for patients with a maturing arteriovenous graft and 135 days (98–198) with a maturing arteriovenous fistula, versus 193 days (138–256) with central venous catheter-only. Pre-dialysis nephrology care, male sex and non-Caucasian race were associated with access conversion. Patients without a maturing arteriovenous fistula or graft had decreased odds of one-year survival (odds ratio = 0.61 (0.58–0.66), p < 0.001), which attenuated with adjustment for access conversion (adjusted odds ratio = 1.06 (0.98–1.13), p = 0.2). Conclusion: Maturing arteriovenous fistulas or grafts were associated with enhanced first-year survival and increased opportunity for working arteriovenous fistulas or grafts, which may reflect pre-dialysis decision-making, quality of care and comorbid diseases. Central venous catheter exposure was substantial, even among patients with maturing access. Contributory factors prolonging conversion to arteriovenous access need to be identified and addressed.

Download Full-text