Postthrombotic syndrome following upper extremity deep vein thrombosis in children

Avila, Laura; Duan, Lucy; Cipolla, Amanda; Kim, Ashley; Kahr, Walter H.A.; Williams, Suzan; Brandão, Leonardo R.

doi:10.1182/blood-2014-04-570531

Cited by 54 publications

(58 citation statements)

References 60 publications

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“…In contrast, little is known about LE-DVT and LE-PTS in children. Whereas during the past decades a great research effort has been devoted to the investigation of risk factors and prevention strategies for LE-PTS affecting adult patients, only recently has the pediatric literature evolved from researching VTE in general to studying of the natural history of VTE at specific sites, such as the upper extremity (UE) 7 or LE.…”

Section: Introductionmentioning

confidence: 99%

Postthrombotic syndrome and other outcomes of lower extremity deep vein thrombosis in children

Avila¹,

Pullenayegum

Williams³

et al. 2016

Blood

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Key Points• The frequency of PTS, PE, and DVT recurrence was higher in children with Non-LR DVT than in children with LR DVT.• Thrombus resolution, DVT triggering event, and sex were predictors of LE PTS in children.Pediatric lower extremity deep vein thrombosis (LE-DVT) can lead to postthrombotic syndrome (PTS) and other adverse events. We investigated the outcomes of LE-DVT in children. Three groups were compared: non-line-related (Non-LR) DVT, LR DVT in neonates (LR neonates ), and LR DVT in non-neonates (LR non-neonates ). A total of 339 children were included (Non-LR, n 5 56; LR neonates , n 5 95; and LR non-neonates , n 5 188). We found a statistically significant difference in the frequency of PTS (P 5 .04; 62.5%, 40.0%, and 46.3% in Non-LR, LR neonates , and LR non-neonates, respectively), of recurrent LE-DVT (P 5 .001; 10.7% and 2.0% in Non-LR and LR non-neonates, respectively), and pulmonary embolism (PE) (P < .001; 19.6% and 3.2% in Non-LR and LR non-neonates, respectively) among groups. There was no difference in DVT resolution (P 5 .41). Multivariable analysis showed that DVT resolution, triggering event, and sex predicted Modified Villalta Scale (MVS; for pediatric PTS) scores >1; there was an interaction between DVT triggering event and sex. The time to reach an MVS >1 was significantly different when comparing groups (log-rank test, P < .001). Moreover, we found a significant difference in baseline MVS scores among groups, but the difference did not appear to change over time. In conclusion, LR LE-DVT had more benign outcomes than Non-LR DVT. Sex, DVT triggering event, and DVT resolution predicted

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Section: Introductionmentioning

confidence: 99%

Postthrombotic syndrome and other outcomes of lower extremity deep vein thrombosis in children

Avila¹,

Pullenayegum

Williams³

et al. 2016

Blood

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“…Further, although estimates of rates of PTS in children vary considerably,7, 9, 10, 11 it has been found to be associated with increased morbidity and cost 39. There have been far fewer studies on the natural history, treatment, and secondary prevention of VTE in children than in adults 1, 9, 40. Collaborative efforts between industry and academia, as in this study, are needed to enable the implementation of well‐designed, adequately powered trials that can address this lack of data and investigate potentially advantageous new anticoagulant options.…”

Section: Discussionmentioning

confidence: 99%

Phase 3, single‐arm, multicenter study of dabigatran etexilate for secondary prevention of venous thromboembolism in children: Rationale and design

Luciani

Albisetti

Biss

et al. 2018

Research and Practice in Thrombosis and Haemostasis

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BackgroundAnticoagulant therapy for venous thromboembolism (VTE) in children is largely based on treatment recommendations for adults. However, differences in both physiology (ie, renal maturation and drug excretion) and developmental hemostasis must be considered when treating children, as such differences could affect dose appropriateness, safety and efficacy.ObjectivesTo address these concerns, a study was designed to evaluate the safety of dabigatran etexilate in children requiring secondary thrombus prevention in whom an initial VTE was associated with an identified risk factor that persisted after the acute VTE treatment period. We report herein the rationale and design of the study.Patients/MethodsThis phase 3, open‐label, single‐arm, multicenter, multinational, prospective cohort study will be conducted in ≥100 children aged 0 to <18 years at ~100 specialist sites worldwide. Children will be treated with dabigatran etexilate for 12 months, or for a shorter duration if their identified VTE risk factor resolves, as per current American College of Chest Physicians recommendations. A nomogram will be used to determine starting doses for each patient.ResultsThe primary outcomes of the study will be VTE recurrence, bleeding events, overall mortality, and VTE‐related mortality. Secondary outcomes will include occurrence of post‐thrombotic syndrome, the pharmacokinetics of dabigatran, and the need for dose adjustments during treatment. Data on adverse events during the study will also be collected.ConclusionThis study will evaluate the safety of dabigatran etexilate for the secondary prevention of VTE in children, in addition to providing further data to guide pediatric dosing with dabigatran.

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“…11,13 The VS was modified for use in children by Kuhle and colleagues and has been studied in several pediatric thrombosis cohorts involving over 550 children. [14][15][16][17][18][19][20] The modifications to the original scale included changing scoring of signs and symptoms 0 to 3 to simple 0 to 1 (absent or present), as well as reducing the number of symptoms to 2 and adding additional signs ( Table 2). PTS classification is as follows: 0 points no PTS, 1 to 3 points mild PTS, 4 to 8 points moderate PTS, >8 points (or presence of a venous ulcer) severe PTS.…”

Section: Pts Scalesmentioning

confidence: 99%

Comparison of 3 Postthrombotic Syndrome Assessment Scales Demonstrates Significant Variability in Children and Adolescents With Deep Vein Thrombosis

Raffini

Davenport²,

Bevilacqua³

et al. 2015

Journal of Pediatric Hematology/Oncology

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Postthrombotic syndrome (PTS) is an important outcome in children with deep vein thrombosis (DVT). There are several instruments to measure PTS, and no accepted "gold standard." The objective of this cross-sectional prospective study was to compare the prevalence of PTS in patients above 8 years old with a history of DVT using 3 scales: the Villalta scale, a pediatric modification of the Villalta scale, and the Manco-Johnson instrument. Forty-four subjects (22 females) were enrolled; mean age 16.6 years (SD 3.6 y). The majority had a lower extremity DVT. The average duration from DVT to PTS assessment was 2.6 years. The proportion of subjects with PTS using the adult Villalta scale was 11%, which was significantly less than the 66% of patients identified using both pediatric scales (P<0.0001). The majority of patients with PTS as determined by the pediatric scales had mild PTS. There was significant discordance between the prevalence of PTS using the Villalta scale compared with the 2 pediatric scales. This is especially relevant when considering which instrument to use in adolescent patients. This study demonstrates that PTS, as defined by these scales, is not a well-defined or standardized outcome, particularly when comparing adult and pediatric instruments.

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Postthrombotic syndrome following upper extremity deep vein thrombosis in children

Cited by 54 publications

References 60 publications

Postthrombotic syndrome and other outcomes of lower extremity deep vein thrombosis in children

Postthrombotic syndrome and other outcomes of lower extremity deep vein thrombosis in children

Phase 3, single‐arm, multicenter study of dabigatran etexilate for secondary prevention of venous thromboembolism in children: Rationale and design

Comparison of 3 Postthrombotic Syndrome Assessment Scales Demonstrates Significant Variability in Children and Adolescents With Deep Vein Thrombosis

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