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991.
Anthonie W. A. Lensing Christoph Male Guy Young Dagmar Kubitza Gili Kenet M. Patricia Massicotte Anthony Chan Angelo C. Molinari Ulrike Nowak-Goettl Ákos F. Pap Ivet Adalbo William T. Smith Amy Mason Kirstin Thelen Scott D. Berkowitz Mark Crowther Stephan Schmidt Victoria Price Martin H. Prins Paul Monagle 《Thrombosis journal》2018,16(1):34
Background
Venous thromboembolism (VTE) is a relatively rare condition in childhood with treatment mainly based on extrapolation from studies in adults. Therefore, clinical trials of anticoagulation in children require novel approaches to deal with numerous challenges. The EINSTEIN-Jr program identified pediatric rivaroxaban regimens commencing with in vitro dose finding studies followed by evaluation of children of different ages through phase I and II studies using extensive modeling to determine bodyweight-related doses. Use of this approach resulted in drug exposure similar to that observed in young adults treated with rivaroxaban 20?mg once-daily.Methods
EINSTEIN-Jr phase III is a randomized, open-label, study comparing the efficacy and safety of rivaroxaban 20?mg-equivalent dose regimens with those of standard anticoagulation for the treatment of any types of acute VTE in children aged 0–18?years.A total of approximately 500 children are expected to be included during the 4-year study window. Flexibility of treatment duration is allowed with study treatment to be given for 3?months with the option to continue treatment in 3-month increments, up to a total of 12?months. However, based on most common current practice, children younger than 2?years with catheter-related thrombosis will have a main treatment period of 1?month with the option to prolong treatment in 1-month increments, up to a total of 3?months.Conclusions
EINSTEIN-Jr will compare previously established 20?mg-equivalent rivaroxaban dosing regimens with standard anticoagulation for the treatment of VTE in children. Demonstration of similarity of disease, as well as equivalent rivaroxaban exposure and exposure-response will enable extrapolation of efficacy from adult trials, which is critical given the challenges of enrollment in pediatric anticoagulation trials.Trial registration
Clinicaltrials.gov NCT02234843, registered on 9 September 2014.992.
Dagmar Kubitza Stefan Willmann Michael Becka Kirstin Thelen Guy Young Leonardo R. Brandão Paul Monagle Christoph Male Anthony Chan Gili Kennet Ida Martinelli Paola Saracco Anthonie W. A. Lensing 《Thrombosis journal》2018,16(1):31
Background
The EINSTEIN-Jr program will evaluate rivaroxaban for the treatment of venous thromboembolism (VTE) in children, targeting exposures similar to the 20 mg once-daily dose for adults.Methods
This was a multinational, single-dose, open-label, phase I study to describe the pharmacodynamics (PD), pharmacokinetics (PK) and safety of a single bodyweight-adjusted rivaroxaban dose in children aged 0.5–18 years. Children who had completed treatment for a venous thromboembolic event were enrolled into four age groups (0.5–2 years, 2–6 years, 6–12 years and 12–18 years) receiving rivaroxaban doses equivalent to 10 mg or 20 mg (either as a tablet or oral suspension). Blood samples for PK and PD analyses were collected within specified time windows.Results
Fifty-nine children were evaluated. In all age groups, PD parameters (prothrombin time, activated partial thromboplastin time and anti-Factor Xa activity) showed a linear relationship versus rivaroxaban plasma concentrations and were in line with previously acquired adult data, as well as in vitro spiking experiments. The rivaroxaban pediatric physiologically based pharmacokinetic model, used to predict the doses for the individual body weight groups, was confirmed. No episodes of bleeding were reported, and treatment-emergent adverse events occurred in four children and all resolved during the study.Conclusions
Bodyweight-adjusted, single-dose rivaroxaban had predictable PK/PD profiles in children across all age groups from 0.5 to 18 years. The PD assessments based on prothrombin time and activated partial thromboplastin time demonstrated that the anticoagulant effect of rivaroxaban was not affected by developmental hemostasis in children.Trial registration
ClinicalTrials.gov number, NCT01145859.993.
Elizabeth Sarah Mayne Malcolm Tait Barry Frank Jacobson Evashin Pillay Susan J. Louw 《Thrombosis journal》2018,16(1):30
Background
Autoimmune paraphenomena, are associated with B-cell lymphoproliferative disorders, including monoclonal gammopathy of uncertain significance. These paraphenomena can rarely include acquired bleeding disorders.Case presentation
This case study reports an unusual clinical presentation of 2 acquired bleeding disorders, Acquired von Willebrand syndrome (disease) and Acquired Glanzmann’s thrombasthenia, in an elderly patient with monoclonal gammopathy of uncertain significance.Conclusions
Acquired bleeding disorders are often underdiagnosed and a high degree of clinical suspicion is required. The patient in this study demonstrated platelet aggregometry which was atypical for isolated Glanzmann’s thrombosthenia because of the severe concomitant endogenous decrease in von Willebrand factor. There was an absence of platelet aggregation to all tested agonists including ristocetin. Once the diagnosis was made, however, the patient showed a partial response to intravenous immunoglobulin confirming the immunological pathogenesis in this case. This case highlights the need to consider acquired bleeding disorders in patients with a possible predisposing factor.994.
Purpose of Review
Recurrent painful ophthalmoplegic neuropathy (RPON), formerly known as ophthalmoplegic migraine, is an uncommon disorder with repeated episodes of ocular cranial nerve neuropathy associated with ipsilateral headache. This review discusses the clinical presentation, current understanding of the pathophysiology, key differential diagnoses, and evaluation and treatment of RPON.Recent Findings
The literature is limited due to the rarity of the disorder. Recent case reports and series continue to suggest the age of first attack is most often during childhood or adolescence as well as a female predominance. Multiple recent case reports and series demonstrate focal enhancement of the affected cranial nerve, as the nerve root exits the brainstem. This finding contributed to the current classification of the disorder as a neuropathy, with the present understanding that it is due to a relapsing-remitting inflammatory or demyelinating process. The link to migraine remains a cause of disagreement in the literature.Summary
RPON is a complex disorder with features of inflammatory neuropathy and an unclear association with migraine. Regardless, the overall prognosis is good for individual episodes, but permanent nerve damage may accumulate with repeated attacks. A better understanding of the pathogenesis is needed to clarify whether it truly represents a single disorder and to guide its treatment. Until that time, a combined approach with acute and preventive therapies can mitigate acute symptoms as well as attempt to limit recurrence of this disabling syndrome.995.
Purpose of Review
The purpose of this review is to provide an update on the clinical features, diagnosis, pathogenesis, epidemiology, and treatment of the rare primary headache disorders short-lasting unilateral neuralgiform headache attacks with conjunctival injection and tearing (SUNCT) and short-lasting unilateral neuralgiform headache attacks with autonomic symptoms (SUNA). Together these entities are known as short-lasting unilateral neuralgiform headache attacks (SUNHA).Recent Findings
Recent case reports of secondary SUNCT and SUNA due to medullary infarcts support the theory that the trigeminohypothalamic pathway is involved in the pathophysiology of SUNHA. While medical therapy for SUNHA has not significantly changed, surgical therapy for refractory SUNCT and SUNA has made advancements with a recent case series demonstrating the efficacy of deep brain stimulation.Summary
We will discuss the pathophysiology of both the pain and the autonomic symptoms experienced in SUNCT and SUNA attacks as well the medical, procedural, and surgical options for treatment with emphasis on recent advances. Specific secondary causes reported in the recent literature will be discussed in brief.996.
Purpose of Review
Pituitary tumors account for approximately 17% of all intracranial neoplasms, with the majority being pituitary adenomas. Often, these are found incidentally during a workup for headache; however, the relationship between symptom and pathology remains unclear. The purpose of this article is to review the most recent literature on the epidemiology, pathophysiology, and management of headaches in patients with pituitary tumors.Recent Findings
The current literature is limited, with few prospective trials focusing on this question. With the exception of pituitary apoplexy, the relationship between headaches and pituitary masses remains unclear. Intervention does not always improve headache and can lead to development of new headache syndromes.Summary
Further research is needed to better elucidate the relationship between pituitary tumors and headaches. Headache alone is rarely an indication for surgical management of a pituitary adenoma.997.
Purpose of Review
Peripheral nerve pain is common among patients with typical management including the use of pain medications, neuropathic agents, steroid injections, and nerve blocks. Additionally, the use of pulsed radiofrequency (PRF) and radiofrequency ablation (RFA) can be used in the management of chronic peripheral nerve pain. Previous studies investigating the effectiveness of RFA and PRF, typically case reports, have demonstrated that peripheral nerve RFA and PRF have the potential to provide relief of chronic pain for long duration. Our study aimed at testing efficacy of RFA/PRF for treating peripheral neuralgia. This was a retrospective review. We identified 16 patients who received 17 RFAs/PRFs. Outcomes of interest collected included pain scores before and after procedures, percent improvement in pain after each procedure, and duration of improvement until the time of data collection. In addition, demographic data including age, sex, and nerves involved were collected.Recent Findings
Eleven patients (12 RFAs/PRFs) (80%) reported improvement after their procedure. Pain scores improved significantly from 6.3?±?2.3 before each procedure to 3.6?±?2.7 after each procedure (p?=?0.003). Eleven patients (12 RFAs/PRFs) reported an average improvement of 60.8%?±?35% after their procedure with an average duration of improvement of 128.8?±?106.8 days.Summary
RFA and PRF can be used to treat chronic peripheral pain after conservative methods fail to do so. Large clinical trials are needed to confirm our finding.998.
Purpose of Review
The complicated nature of chronic pain involves an interplay between psychological and physical factors, often resulting in increased emotional distress and reduced quality of life. This review is designed to help the medical practitioner who is working with chronic pain patients to be aware of psychological assessment techniques that can add to comprehensive patient understanding and more effectively guide treatment. Enhanced ability to assess and understand the emotional life of the chronic pain patient provides a basis for intervening and treating more successfully.Recent Findings
There are a broad range of assessment techniques, some of which require a background in psychology and some that do not, that can identify psychological differences in chronic pain patients and serve to guide intervention strategies. Chronic pain is often comorbid with depression, anxiety, catastrophizing, and various ineffective coping strategies. Some patients, however, have demonstrated more adaptive and effective strategies for cognitively and behaviorally coping with pain and normalizing their lives. Proper assessment enables the individualization of treatment to overcome and/or build upon each patient’s psychological frame of mind to maximize the potential for effective functioning.Summary
The use of standardized and documented psychological assessment techniques can lead to a better understanding of chronic pain patients and contribute in ways that can enhance response to medical treatment and improve quality of life. It is recommended that certain psychological tools be included to supplement the medical assessment of patients who have chronic pain. A basic assessment can include a short psychological-based clinical interview along with brief measures of depression, anxiety, and coping strategies. It is also recommended that the pain physician have access to professional psychological practitioners as a resource for more complicated assessments and psychological intervention services.999.
Purpose of Review
The hippocampus is involved in pain processing, pain-related attention and anxiety, and stress response. The present review compiles the present knowledge of hippocampal volume, activity, and connectivity regarding migraine.Recent Findings
For hippocampal volume, a longitudinal study discovered decreased volume in newly diagnosed migraine patients after 1 year. Two cross-sectional studies suggested an adaptive increase of volume at low headache frequency and a maladaptive decrease of volume at higher headache frequency. Patients who carried a COMT Val homozygous were found to have larger hippocampi on both sides compared with healthy controls with the same polymorphism. For hippocampal activation, one study showed greater nociceptive activation in patients with migraine compared to healthy controls, with the activity correlated to headache frequency. Another study showed greater deactivation and higher functional connectivity linked to other pain-processing regions in low frequency compared to high-frequency migraineurs. At resting state, intraregional functional connectivity of hippocampus was demonstrated to be lower, and connectivity of the hippocampus with other brain regions was different in patients carrying specific genetic variants. For structural connectivity, two studies suggest a stronger connectivity between the hippocampus and other corticolimbic regions, and the altered connectivities are responsible for migraine-associated allodynia or placebo effect of migraine.Summary
Factors including headache frequency, accumulative number of migraine attacks, anxiety score, depression score, and genetic variants are related to hippocampal morphology and functional changes in people with migraine. Future studies should select participants precisely and appropriately control for genetic variants to investigate the complex relationship between the hippocampus and migraine.1000.
Maryam Aghighi Laura Pisani Ashok J. Theruvath Anne M. Muehe Jessica Donig Ramsha Khan Samantha J. Holdsworth Neeraja Kambham Waldo Concepcion Paul C. Grimm Heike E. Daldrup-Link 《Molecular imaging and biology》2018,20(1):139-149