scholarly journals One-year efficacy and safety of the Trufill DCS Orbit and Orbit Galaxy detachable coils in the endovascular treatment of intracranial aneurysms: Results from the TRULINE study

2017 ◽  
Vol 23 (5) ◽  
pp. 485-491 ◽  
Author(s):  
Benjamin Gory ◽  
Laure Huot ◽  
Roberto Riva ◽  
Paul E Labeyrie ◽  
Olivier Levrier ◽  
...  

Background and purpose No series reported the mid-term results of Trufill DCS Orbit and Orbit Galaxy detachable coils with independent evaluation. We present the one-year safety and efficacy of these coils in real-life routine clinical practice. Methods A total of 167 patients with 167 aneurysms (39.1% ruptured) were enrolled in the prospective TRULINE study. The primary endpoint was the safety, assessed by the combined morbidity-mortality rate observed since the time of the procedure and up to one-year follow-up. For safety, primary analyses were performed on intent-to-treat population (attempted coils procedure) and all adverse events have been reviewed by an independent Data Safety Monitoring Board. For efficacy, primary analyses were performed on the per-protocol population (patients treated with more than 70% of Trufill coils and not retreated during the follow-up period) and an independent core laboratory evaluated angiographic results. Results At one-year post-procedure, neurologic impairment was observed in 6.5% (95% confidence interval: 3.5–11.8) of the patients, and 2.6% (95% confidence interval: 1.0–6.8) had a permanent neurological deterioration. Three deaths were observed, unrelated to the procedure or coils. At one year, complete occlusion was seen in 52 aneurysms (54.2%), neck remnant in 28 aneurysms (29.2%), and aneurysm remnant in 16 aneurysms (16.7%). During the one-year follow-up, the overall incidence of recurrence was 30.2% with a mean interval of 13.8 ± 4.5 months and the retreatment for major recanalization was needed in nine patients (6.3%). Conclusions The TRULINE study confirms that endovascular coiling with Trufill DCS Orbit and Orbit Galaxy detachable coils is safe and effective.

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 415-415
Author(s):  
Aurelien Delluc ◽  
Karine Lacut ◽  
Jean Christophe Ianotto ◽  
Cecile Tromeur ◽  
Francis Couturaud ◽  
...  

Abstract Background: Venous thromboembolism (VTE) can be the first manifestation of cancer. Whether screening for an occult malignancy should be systematically performed in patients with unprovoked VTE is a daily challenge for clinicians. Recently, two randomized trials demonstrated that limited cancer screening in patients with a first unprovoked VTE could be the standard of care. However, the one-year incidence of occult malignancy found in these trials was unexpectedly low (4.5%) raising the hypothesis of an inclusion bias. We aimed at estimating the real-life one-year incidence of cancer following a first unprovoked VTE to inform physicians and policy makers in establishing recommendations for cancer screening in VTE patients. Methods: The EPIGETBO study is an epidemiologic study that aimed to measure the incidence of VTE in the Brest District, France1. All symptomatic VTE cases (deep vein thrombosis of the lower limb and pulmonary embolism) diagnosed between March 1st, 2013 and February 28th, 2014 among the 367,911 inhabitants of the district were recorded and validated by an adjudication committee. A systematic follow-up was planned in order to study patients' outcome. Unprovoked VTE was defined as the absence of surgical procedure, pregnancy, delivery, immobilization, admission to hospital for an acute medical illness in the 3 months preceding VTE or known active cancer. The 1-year cumulative incidence of cancer was estimated using the Kaplan-Meier method. Then, the hazard for occult cancer diagnosis associated with age>60, male sex, and current smoking was assessed by Cox regression. Results: During the study period, 576 symptomatic validated VTE events were diagnosed in 562 inhabitants of the Brest District. Five patients did not undergo follow-up (4 refusals, 1 aged<18). The VTE event at study entry was unprovoked in 310 patients (55.6%) and this was a first unprovoked VTE event in 257. Patients' mean age was 67.9 ± 2.2 years, 114 (44.3%) were men, 38 (14.8%) had a prior unprovoked VTE event. In the year following VTE, 9 of the 257 patients with a first unprovoked VTE event were diagnosed with cancer, corresponding to an overall 1-year cumulative incidence of occult cancer of 3.68% (95% CI 1.93-6.96). This incidence was 3.78% (95% CI 1.91-7.43) in the 219 patients with a first unprovoked VTE event and no prior history of provoked VTE (8 cancers). In non-smokers, the 1-year incidence rate of occult cancer was 0.81% (95% CI 0.11-5.59) as compared with 8.05% (95% CI 3.92-16.14) in smokers (p=0.004 by log-rank test). In multivariate analysis, age>60 and male sex were associated with a non significant increased risk for occult cancer diagnosis (HR 4.92; 95% CI 0.60-40.30 and 1.42; 95% CI 0.25-8.13 respectively). Conversely, current smoking was independently associated with a significant 11.8-fold increased risk for occult cancer diagnosis (HR 11.80; 95% CI 1.19-116.52). No cancer was diagnosed in patients aged≤50 years. Conclusion: In this comprehensive real-life epidemiological study, we confirmed that the one-year incidence of occult malignancy following a first episode of unprovoked VTE is low, especially in non-smokers. Current smoking was associated with a higher risk for occult cancer diagnosis; however, even in this patient subgroup, the absolute frequency was no higher than 8%. 1 Thromb Haemost 2016; Epub ahead of print DOI: 10.1160/TH16-03-0205 Disclosures No relevant conflicts of interest to declare.


VASA ◽  
2012 ◽  
Vol 41 (2) ◽  
pp. 120-124 ◽  
Author(s):  
Asciutto ◽  
Lindblad

Background: The aim of this study is to report the short-term results of catheter-directed foam sclerotherapy (CDFS) in the treatment of axial saphenous vein incompetence. Patients and methods: Data of all patients undergoing CDFS for symptomatic primary incompetence of the great or small saphenous vein were prospectively collected. Treatment results in terms of occlusion rate and patients’ grade of satisfaction were analysed. All successfully treated patients underwent clinical and duplex follow-up examinations one year postoperatively. Results: Between September 2006 and September 2010, 357 limbs (337 patients) were treated with CDFS at our institution. Based on the CEAP classification, 64 were allocated to clinical class C3 , 128 to class C4, 102 to class C5 and 63 to class C6. Of the 188 patients who completed the one year follow up examination, 67 % had a complete and 14 % a near complete obliteration of the treated vessel. An ulcer-healing rate of 54 % was detected. 92 % of the patients were satisfied with the results of treatment. We registered six cases of thrombophlebitis and two cases of venous thromboembolism, all requiring treatment. Conclusions: The short-term results of CDFS in patients with axial vein incompetence are acceptable in terms of occlusion and complications rates.


2021 ◽  
Vol 14 (1) ◽  
Author(s):  
Afona Chernet ◽  
Nicole Probst-Hensch ◽  
Véronique Sydow ◽  
Daniel H. Paris ◽  
Niklaus D. Labhardt

Abstract Objective Eritrea is the most frequent country of origin among asylum seekers in Switzerland. On their journey through the desert and across the Mediterranean Sea, Eritrea refugees are often exposed to traumatizing experiences. The aim of this study is to assess the mental health status and resilience of Eritrean migrants in Switzerland upon arrival and one-year post-arrival, using standardized mental health screening and resilience assessment tools. Results At baseline, 107 refugees (11.2% female, median age 25) were interviewed: 52 (48.6%) screened positive for Post-Traumatic Stress Disorder (score ≥ 30), 10.3% for anxiety (≥ 10) and 15.0% for depression (≥ 10); 17.8% scored as risk/hazardous drinkers (≥ 8). The majority (94.4%) had a high resilience score (≥ 65). For one-year follow-up, 48 asylum seekers could be reached. In interviews 18 (38%) of these reported imprisonment in a transit country and 28 (58%) that they had witnessed the death of a close person along the migration route. At the one year assessment, rates of risky/hazardous alcohol use remained unchanged, rates of positive PTSD screening tended to be lower (50.0% (24/48) at baseline vs 25.0% (12/48) at follow-up), as were rates of positive screening for anxiety (8.3% vs 4.2%) and depression (14.6 vs 6.3%).


2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1463.2-1464
Author(s):  
S. Bayat ◽  
K. Tascilar ◽  
V. Kaufmann ◽  
A. Kleyer ◽  
D. Simon ◽  
...  

Background:Recent developments of targeted treatments such as targeted synthetic DMARDs (tsDMARDs) increase the chances of a sustained low disease activity (LDA) or remission state for patients suffering rheumatoid arthritis (RA). tsDMARDs such as baricitinib, an oral inhibitor of the Janus Kinases (JAK1/JAK2) was recently approved for the treatment of RA with an inadequate response to conventional (cDMARD) and biological (bDMARD) therapy. (1, 2).Objectives:Aim of this study is to analyze the effect of baricitinb on disease activity (DAS28, LDA) in patients with RA in real life, to analyze drug persistance and associate these effects with various baseline characteristics.Methods:All RA patients were seen in our outpatient clinic. If a patient was switched to a baricitinib due to medical reasons, these patients were included in our prospective, observational study which started in April 2017. Clinical scores (SJC/TJC 76/78), composite scores (DAS28), PROs (HAQ-DI; RAID; FACIT), safety parameters (not reported in this abstract) as well as laboratory biomarkers were collected at each visit every three months. Linear mixed effects models for repeated measurements were used to analyze the time course of disease activity, patient reported outcomes and laboratory results. We estimated the probabilities of continued baricitinib treatment and the probabilities of LDA and remission by DAS-28 as well as Boolean remission up to one year using survival analysis and explored their association with disease characteristics using multivariable Cox regression. All patients gave informed consent. The study is approved by the local ethics.Results:95 patients were included and 85 analyzed with available follow-up data until November 2019. Demographics are shown in table 1. Mean follow-up duration after starting baricitinib was 49.3 (28.9) weeks. 51 patients (60%) were on monotherapy. Baricitinib survival (95%CI) was 82% (73% to 91%) at one year. Cumulative number (%probability, 95%CI) of patients that attained DAS-28 LDA at least once up to one year was 67 (92%, 80% to 97%) and the number of patients attaining DAS-28 and Boolean remission were 31 (50%, 34% to 61%) and 12(20%, 9% to 30%) respectively. Median time to DAS-28 LDA was 16 weeks (Figure 1). Cox regression analyses did not show any sufficiently precise association of remission or LDA with age, gender, seropositivity, disease duration, concomitant DMARD use and number of previous bDMARDs. Increasing number of previous bDMARDs was associated with poor baricitinib survival (HR=1.5, 95%CI 1.1 to 2.2) while this association was not robust to adjustment for baseline disease activity. Favorable changes were observed in tender and swollen joint counts, pain-VAS, patient and physician disease assessment scores, RAID, FACIT and the acute phase response.Conclusion:In this prospective observational study, we observed high rates of LDA and DAS-28 remission and significant improvements in disease activity and patient reported outcome measurements over time.References:[1]Keystone EC, Taylor PC, Drescher E, Schlichting DE, Beattie SD, Berclaz PY, et al. Safety and efficacy of baricitinib at 24 weeks in patients with rheumatoid arthritis who have had an inadequate response to methotrexate. Annals of the rheumatic diseases. 2015 Feb;74(2):333-40.[2]Genovese MC, Kremer J, Zamani O, Ludivico C, Krogulec M, Xie L, et al. Baricitinib in Patients with Refractory Rheumatoid Arthritis. The New England journal of medicine. 2016 Mar 31;374(13):1243-52.Figure 1.Cumulative probability of low disease activity or remission under treatment with baricitinib.Disclosure of Interests:Sara Bayat Speakers bureau: Novartis, Koray Tascilar: None declared, Veronica Kaufmann: None declared, Arnd Kleyer Consultant of: Lilly, Gilead, Novartis,Abbvie, Speakers bureau: Novartis, Lilly, David Simon Grant/research support from: Else Kröner-Memorial Scholarship, Novartis, Consultant of: Novartis, Lilly, Johannes Knitza Grant/research support from: Research Grant: Novartis, Fabian Hartmann: None declared, Susanne Adam: None declared, Axel Hueber Grant/research support from: Novartis, Lilly, Pfizer, EIT Health, EU-IMI, DFG, Universität Erlangen (EFI), Consultant of: Abbvie, BMS, Celgene, Gilead, GSK, Lilly, Novartis, Speakers bureau: GSK, Lilly, Novartis, Georg Schett Speakers bureau: AbbVie, BMS, Celgene, Janssen, Eli Lilly, Novartis, Roche and UCB


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Jirarattanasopa Pichai ◽  
Banchasakjaroen Vanchalerm ◽  
Ratanasukon Mansing

Abstract Background Central serous chorioretinopathy (CSC) is characterized by an accumulation of subretinal fluid (SRF) in the macula. It is usually treated by laser photocoagulation or photodynamic therapy (PDT) with consisting of different doses and power. This study aimed to compare the efficacy of half-dose PDT and one-third-dose PDT in chronic or recurrent CSC. Methods A retrospective review of patients with chronic or recurrent CSC who were treated with either a half-dose or one-third-dose PDT, and had follow up 12 months afterwards. Best-corrected visual acuity (BCVA), central retinal thickness (CRT) and resolution of subretinal fluid (SRF) at baseline as well as 1, 3, 6 and 12 months post-PDT were assessed. Results Forty-six eyes and 20 eyes received half-dose and one-third-dose PDT, respectively. The study showed efficacy of the one-third-dose PDT compared with half-dose PDT in BCVA improvement (0.10±0.04 logMAR for one-third-dose versus 0.17±0.04, for half-dose, P=0.148) and CRT improvement (125.6±24.6 μm for one-third-dose versus 139.1±16.54, for half-dose, P=0.933) at 12 months. The SRF recurrence rate was significantly higher in the one-third-dose PDT group compared with the half-dose PDT group (40.0% versus 15.2%, P=0.027) at 12-months. Conclusion At 12 months, the one-third-dose PDT was effective in terms of BCVA and CRT improvement, when compared with half-dose PDT. However, this study showed that one-third-dose PDT had a higher recurrence rate of SRF.


Author(s):  
Shinwan Kany ◽  
Johannes Brachmann ◽  
Thorsten Lewalter ◽  
Ibrahim Akin ◽  
Horst Sievert ◽  
...  

Abstract Background Non-paroxysmal (NPAF) forms of atrial fibrillation (AF) have been reported to be associated with an increased risk for systemic embolism or death. Methods Comparison of procedural details and long-term outcomes in patients (pts) with paroxysmal AF (PAF) against controls with NPAF in the prospective, multicentre observational registry of patients undergoing LAAC (LAARGE). Results A total of 638 pts (PAF 274 pts, NPAF 364 pts) were enrolled. In both groups, a history of PVI was rare (4.0% vs 1.6%, p = 0.066). The total CHA2DS2-VASc score was lower in the PAF group (4.4 ± 1.5 vs 4.6 ± 1.5, p = 0.033), while HAS-BLED score (3.8 ± 1.1 vs 3.9 ± 1.1, p = 0.40) was comparable. The rate of successful implantation was equally high (97.4% vs 97.8%, p = 0.77). In the three-month echo follow-up, LA thrombi (2.1% vs 7.3%, p = 0.12) and peridevice leak > 5 mm (0.0% vs 7.1%, p = 0.53) were numerically higher in the NPAF group. Overall, in-hospital complications occurred in 15.0% of the PAF cohort and 10.7% of the NPAF cohort (p = 0.12). In the one-year follow-up, unadjusted mortality (8.4% vs 14.0%, p = 0.039) and combined outcome of death, stroke and systemic embolism (8.8% vs 15.1%, p = 0.022) were significantly higher in the NPAF cohort. After adjusting for CHA2DS2-VASc and previous bleeding, NPAF was associated with increased death/stroke/systemic embolism (HR 1.67, 95% CI 1.02–2.72, p = 0.041). Conclusion Atrial fibrillation type did not impair periprocedural safety or in-hospital MACE patients undergoing LAAC. However, after one year, NPAF was associated with higher mortality. Graphic abstract


2015 ◽  
Vol 2015 ◽  
pp. 1-4
Author(s):  
Heves Kırmızıbekmez ◽  
Rahime Gül Yesiltepe Mutlu ◽  
Serdar Moralıoğlu ◽  
Ahmet Tellioğlu ◽  
Ayşenur Cerrah Celayir

Congenital adrenal hyperplasia (CAH) is a group of inherited defects of cortisol biosynthesis. A case of classical CAH due to 21-hydroxylase deficiency (21-OHD) with early onset of salt waste and concurrence of meningomyelocele (MMC) was presented here. The management of salt-wasting crisis which is complicated by a postrenal dysfunction due to neurogenic bladder was described. Possible reasons of growth retardation in the one-year follow-up period were discussed. A significant regression of the phallus with proper medical treatment was also mentioned.


2021 ◽  
pp. 27-29
Author(s):  
Maitri Hathi ◽  
Sudesh Kumar

Aprevious paper reported the six month comparison of weight loss in overweight and/or obese adults randomly assigned to either a VLCK-diet or LF-diet. To review the one year outcomes between these diets 1year follow-up of a randomized trial on 113 overweight/obese adults with a BMI>25 kg/m2; with no abnormalities were randomly selected. Participants who selected VLCK diet received counseling to restrict carbohydrate intake to <30 gram per day and those who selected LF diet received counseling to restrict caloric intake by 500 calories per day with <30% of calories from fat. Changes in weight, Body Mass Index, Body Fat, and Waist Circumference were measured at intervals of rst, third, sixth and twelfth month of participants who completed the one-year follow-up. Participants on the very-low-carbohydrate diet had lost more weight loss than participants on the conventional low-fat diet at 3months, 6month and but the difference at 12months were signicant. Study conclude that participants on a VLCK-diet had more favorable overall outcomes at 1year than did those on a conventional LF-diet. Weight loss was similar between groups.


2012 ◽  
Vol 36 (1) ◽  
pp. 13-26 ◽  
Author(s):  
Nina Biehal ◽  
Sarah Ellison ◽  
Ian Sinclair

Nina Biehal, Sarah Ellison and Ian Sinclair present the results of an independent evaluation of the Multidimensional Treatment Foster Care (MTFC) programme for young offenders in England, where it is known as Intensive Fostering (IF). A quasi-experimental, mixed-methods study was carried out at the three pilot sites, with a total sample of 47 at follow-up. Young people sentenced to IF were compared to a similar group, matched on the eligibility criteria for IF, the majority of whom were sentenced to custody. The groups were well matched in terms of their characteristics and criminal histories. Official data on reconviction were collected at baseline and one year after entry to the IF placement or release from custody (Stage 1), and further data on programme completion and secondary outcomes were collected via interviews with young people and parents, and questionnaires to professionals at baseline and follow-up. Official data on reconviction were also collected one year after exit from the IF placements (Stage 2). At Stage 1 the IF group were less likely to be reconvicted, had committed fewer and less-serious recorded offences, on average, and took longer to commit their first recorded offence. At this point the IF group were more likely to be living with their families and less likely to be in custody than the comparison group. However, by Stage 2 no significant differences in patterns of reconviction remained. IF successfully contained a high-risk group in the community, but the effects of the intervention diminished once they left their foster placements. Environmental effects on entry to and exit from the IF placements may help to explain the results at both stages.


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