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Arbelo E.,Hospital Clinic Of Barcelona | Brugada J.,Hospital Clinic Of Barcelona | Hindricks G.,University of Leipzig | Maggioni A.P.,EURObservational Research Programme | And 15 more authors.
European Heart Journal | Year: 2014

Aims The Atrial Fibrillation Ablation Pilot Study is a prospective registry designed to describe the clinical epidemiology of patients undergoing an atrial fibrillation (AFib) ablation, and the diagnostic/therapeutic processes applied across Europe. The aims of the 1-year follow-up were to analyse how centres assess in routine clinical practice the success of the procedure and to evaluate the success rate and long-term safety/complications. Methods and results Seventy-two centres in 10 European countries were asked to enrol 20 consecutive patients undergoing a first AFib ablation procedure. A web-based case report form captured information on pre-procedural, procedural, and 1-year follow-up data. Between October 2010 and May 2011, 1410 patients were included and 1391 underwent an AFib ablation (98.7%). A total of 1300 patients (93.5%) completed a follow-up control 367 ± 42 days after the procedure. Arrhythmia documentation was done by an electrocardiogram in 76%, Holter-monitoring in 52%, transtelephonic monitoring in 8%, and/or implanted systems in 4.5%. Over 50% became asymptomatic. Twenty-one per cent were re-admitted due to post-ablation arrhythmias. Success without antiarrhythmic drugs was achieved in 40.7% of patients (43.7% in paroxysmal AF; 30.2% in persistent AF; 36.7% in long-lasting persistent AF). A second ablation was required in 18% of the cases and 43.4% were under antiarrhythmic treatment. Thirty-three patients (2.5%) suffered an adverse event, 272 (21%) experienced a left atrial tachycardia, and 4 patients died (1 haemorrhagic stroke, 1 ventricular fibrillation in a patient with ischaemic heart disease, 1 cancer, and 1 of unknown cause). Conclusion The AFib Ablation Pilot Study provided crucial information on the epidemiology, management, and outcomes of catheter ablation of AFib in a real-world setting. The methods used to assess the success of the procedure appeared at least suboptimal. Even in this context, the 12-month success rate appears to be somewhat lower to the one reported clinical trials. © The Author 2014.


Bansch D.,University of Rostock | Bonnemeier H.,University of Kiel | Brandt J.,Skåne University Hospital | Bode F.,University of Lübeck | And 8 more authors.
European Heart Journal | Year: 2015

Aims This trial was designed to test the hypothesis that shock efficacy during follow-up is not impaired in patients implanted without defibrillation (DF) testing during first implantable cardioverter-defibrillator (ICD) implantation. Methods and results Between February 2011 and July 2013, 1077 patients were randomly assigned (1: 1) to first time ICD implantation with (n = 540) or without (n = 537) DF testing. The intra-operative DF testing was standardized across all participating centres, and all ICD shocks were programmed to 40 J irrespective of DF test results. The primary end point was the average first shock efficacy (FSE) for all true ventricular tachycardia and fibrillation (VT/VF) episodes during follow-up. The secondary end points included procedural data, serious adverse events, and mortality. During a median follow-up of 22.8 months, the model-based FSE was found to be non-inferior in patients with an ICD implanted without a DF test, with a difference in FSE of 3.0% in favour of the no DF test [confidence interval (CI) -3.0 to 9.0%, Pnon-inferiority <0.001 for the pre-defined non-inferiority margin of -10%). A total of 112 procedure-related serious adverse events occurred within 30 days in 94 patients (17.6%) tested compared with 89 events in 74 patients (13.9%) not tested (P = 0.095). Conclusion Defibrillation efficacy during follow-up is not inferior in patients with a 40 J ICD implanted without DF testing. Defibrillation testing during first time ICD implantation should no longer be recommended for routine left-sided ICD implantation. © 2015 The Author 2015. Published by Oxford University Press on behalf of the European Society of Cardiology.


PubMed | DRK Hospital Molln Ratzeburg, Copenhagen University, University of Hamburg, University of Kiel and 6 more.
Type: Journal Article | Journal: European heart journal | Year: 2015

This trial was designed to test the hypothesis that shock efficacy during follow-up is not impaired in patients implanted without defibrillation (DF) testing during first implantable cardioverter-defibrillator (ICD) implantation.Between February 2011 and July 2013, 1077 patients were randomly assigned (1 : 1) to first time ICD implantation with (n = 540) or without (n = 537) DF testing. The intra-operative DF testing was standardized across all participating centres, and all ICD shocks were programmed to 40 J irrespective of DF test results. The primary end point was the average first shock efficacy (FSE) for all true ventricular tachycardia and fibrillation (VT/VF) episodes during follow-up. The secondary end points included procedural data, serious adverse events, and mortality. During a median follow-up of 22.8 months, the model-based FSE was found to be non-inferior in patients with an ICD implanted without a DF test, with a difference in FSE of 3.0% in favour of the no DF test [confidence interval (CI) -3.0 to 9.0%, Pnon-inferiority <0.001 for the pre-defined non-inferiority margin of -10%). A total of 112 procedure-related serious adverse events occurred within 30 days in 94 patients (17.6%) tested compared with 89 events in 74 patients (13.9%) not tested (P = 0.095).Defibrillation efficacy during follow-up is not inferior in patients with a 40 J ICD implanted without DF testing. Defibrillation testing during first time ICD implantation should no longer be recommended for routine left-sided ICD implantation.


Arbelo E.,University of Barcelona | Brugada J.,University of Barcelona | Hindricks G.,University of Leipzig | Maggioni A.,Associazione Nazionale Medici Cardiologi Ospedalieri Research Center | And 14 more authors.
Europace | Year: 2012

AimsThe Atrial Fibrillation Ablation Pilot Study is a prospective, multinational registry conducted by the European Heart Rhythm Association of the European Society of Cardiology that has been designed to describe the clinical epidemiology of patients undergoing an atrial fibrillation (AFib) ablation procedure, and the diagnostic/therapeutic processes applied in these patients across Europe. We present the results of the short-term (in-hospital) analysis. Methods and resultsA total of 72 centres in 10 European countries were asked to enrol 20 consecutive patients scheduled for a first AFib ablation procedure. Between October 2010 and May 2011, 1410 patients were included, of which 1391 underwent an AFib ablation (98.7). The median age was 60 years [inter-quartile range (IQR) 5266], and 28 were females. Two-thirds presented paroxysmal AFib and 38 lone AFib. Symptoms were present in 86. The indications for ablation were mostly symptomatic AFib, but in over a third of patients there was also a desire for a drug-free lifestyle and the maintenance of sinus rhythm. Pulmonary vein isolation was attempted in 98.4 of patients, the roof line in 21.3 and the mitral isthmus line in 12.8. Complex-fractionated atrial electrograms were targeted in 17.9 and the ganglionated plexi in 3.3. Complications occurred in 7.7, of which 1.7 was major (i.e. cardiac perforation, myocardial infraction, endocarditis, cardiac arrest, stroke, hemothorax, pneumothorax, and sepsis). The median duration of hospitalization was 3 days (IQR 24). At discharge, 91.4 of patients were in sinus rhythm, 88.3 of patients were given vitamin K antagonists, and 67 antiarrhythmic medication. There was one death after the ablation procedure. ConclusionThe AFib Ablation Pilot Study provides crucial information on AF ablation in clinical practice across Europe. These data are relevant for further improvement of the management strategies of patients suffering from atrial fibrillation. © 2012 The Author.


Balik V.,Faculty Hospital Olomouc | Srovnal J.,Palacky University | Sulla I.,University of Veterinary Medicine in Kosice | Kalita O.,Faculty Hospital Olomouc | And 4 more authors.
Journal of Neuro-Oncology | Year: 2013

Meningiomas represent one of the most common types of primary intracranial tumours. However, the specific molecular mechanisms underlying their pathogenesis remain uncertain. Loss of chromosomes 22q, 1p, and 14q have been implicated in most meningiomas. Inactivation of the NF2 gene at 22q12 has been identified as an early event in their pathogenesis, whereas abnormalities of chromosome 14 have been reported in higher-grade as well as recurrent tumours. It has long been supposed that chromosome 14q32 contains a tumour suppressor gene. However, the identity of the potential 14q32 tumour suppressor remained elusive until the Maternally Expressed Gene 3 (MEG3) was recently suggested as an ideal candidate. MEG3 is an imprinted gene located at 14q32 that encodes a non-coding RNA (ncRNA). In meningiomas, loss of MEG3 expression, its genomic DNA deletion and degree of promoter methylation have been found to be associated with aggressive tumour growth. These findings indicate that MEG3 may have a significant role as a novel long noncoding RNA tumour suppressor in meningiomas. © 2013 Springer Science+Business Media New York.


Angiolillo D.J.,University of Florida | Firstenberg M.S.,Ohio State University | Price M.J.,Scripps Research Institute | Tummala P.E.,Northeast Georgia Heart Center | And 13 more authors.
JAMA - Journal of the American Medical Association | Year: 2012

Context: Thienopyridines are among the most widely prescribed medications, but their use can be complicated by the unanticipated need for surgery. Despite increased risk of thrombosis, guidelines recommend discontinuing thienopyridines 5 to 7 days prior to surgery to minimize bleeding. Objective: To evaluate the use of cangrelor, an intravenous, reversible P2Y 12 platelet inhibitor for bridging thienopyridine-treated patients to coronary artery bypass grafting (CABG) surgery. Design, Setting, and Patients: Prospective, randomized, double-blind, placebocontrolled, multicenter trial, involving 210 patients with an acute coronary syndrome (ACS) or treated with a coronary stent and receiving a thienopyridine awaiting CABG surgery to receive either cangrelor or placebo after an initial open-label, dose-finding phase (n=11) conducted between January 2009 and April 2011. Interventions Thienopyridines were stopped and patients were administered cangrelor or placebo for at least 48 hours, which was discontinued 1 to 6 hours before CABG surgery. Main Outcome Measures: The primary efficacy end point was platelet reactivity (measured in P2Y 12 reaction units [PRUs]), assessed daily. The main safety end point was excessive CABG surgery-related bleeding. Results The dose of cangrelor determined in 10 patients in the open-label stage was 0.75 μg/kg per minute. In the randomized phase, a greater proportion of patients treated with cangrelor had low levels of platelet reactivity throughout the entire treatment period compared with placebo (primary end point, PRU <240; 98.8% (83 of 84) vs 19.0% (16 of 84); relative risk [RR], 5.2 [95% CI, 3.3-8.1] P<.001). Excessive CABG surgery-related bleeding occurred in 11.8% (12 of 102) vs 10.4% (10 of 96) in the cangrelor and placebo groups, respectively (RR, 1.1 [95% CI, 0.5-2.5] P=.763). There were no significant differences in major bleeding prior to CABG surgery, although minor bleeding episodes were numerically higher with cangrelor. Conclusions: Among patients who discontinue thienopyridine therapy prior to cardiac surgery, the use of cangrelor compared with placebo resulted in a higher rate of maintenance of platelet inhibition. Trial Registration: clinicaltrials.gov Identifier: NCT00767507. ©2012 American Medical Association. All rights reserved.


Balik V.,Faculty Hospital Olomouc | Kolembus P.,Faculty Hospital Olomouc | Svajdler M.,University Hospital steur Kosice | Sulla I.,University of Veterinary Medicine in Kosice | And 2 more authors.
Clinical Neurology and Neurosurgery | Year: 2013

Objective: This report illustrates the rare rapid spontaneous redistribution of an acute intracranial supratentorial subdural hematoma (AISSDH) to the entire spinal subdural space (SSS). The study is also unique in that the spinal subdural hematoma (SSH) manifested by the extremely rare Pourfour du Petit Syndrome (PPS). Methods: A 66-year-old man sustained blunt head trauma. On admission to the regional hospital, he scored 6 on GCS and his pupils were of equal size reacting to light. Initial computed tomography (CT) scan showed a unilateral AISSDH. The patient was referred to our department and arrived 16 h following the accident, at which time a repeat CT scan revealed almost complete resolution of the AISSDH without clinical improvement. On the 9th postinjury day transient anisocoria and tachycardia without spinal symptomatology developed. Since neither neurological examination nor follow-up CT scans showed intracranial pathology explaining the anisocoria, the patient was treated further conservatively. During the next 3 days circulatory instability developed and the patient succumbed to primary traumatic injury. Autopsy revealed a SSH occupying the entire SSS. Conclusion: This case calls attention to the unique combination of the displacement of an AISSDH to the SSS and the presentation of this clinical entity by the PPS. © 2012 Elsevier B.V. All rights reserved.


Hill M.,Institute of Endocrinology | Paskova A.,General Teaching Hospital | Kanceva R.,Institute of Endocrinology | Velikova M.,Institute of Endocrinology | And 11 more authors.
Journal of Steroid Biochemistry and Molecular Biology | Year: 2014

In this review we focused on steroid metabolomics in human fetuses and newborns and its role in the physiology and pathophysiology of human pregnancy and subsequent stages of human life, and on the physiological relevance of steroids influencing the nervous systems with regards to their concentrations in the fetus. Steroid profiling provides valuable data for the diagnostics of diseases related to altered steroidogenesis in the fetal and maternal compartments and placenta. We outlined a potential use of steroid metabolomics for the prediction of reproductive disorders, misbalance of hypothalamic- pituitary-adrenal axis, and impaired insulin sensitivity in subsequent stages of human life. A possible role of steroids exhibiting a non-genomic effect in the development of gestational diabetes and in the neuroprotection via negative modulation of AMPA/kainate receptors was also indicated. Increasing progesterone synthesis and catabolism, declining production of tocolytic 5β-pregnane steroids, and rising activities of steroid sulfotransferases with the approaching term may be of importance in sustaining pregnancy. An increasing trend was demonstrated with advancing gestation toward the production of ketones (and 3β-hydroxyl groups in the case of 3α-hydroxy-steroids) was demonstrated in the fetus on the expense of 3α-hydroxy-, 17β-hydroxy-, and 20α-hydroxy-groups weakening in the sequence C17, C3, and C20. There was higher production of active progestogen but lower production of active estrogen and GABAergic steroids with the approaching term. Rising activities of placental CYP19A1 and oxidative isoforms of HSD17B, and of fetal CYP3A7 with advancing gestation may protect the fetus from hyperestrogenization. This article is part of a Special Issue entitled 'Pregnancy and Steroids'. © 2013 Elsevier Ltd. All rights reserved.


Steckova T.,Palacky University | Hlustik P.,Palacky University | Sladkova V.,Palacky University | Odstrcil F.,Faculty Hospital Olomouc | And 2 more authors.
Journal of the Neurological Sciences | Year: 2014

Background: Cognitive deficits worsen the quality of life in multiple sclerosis and may be predicted by deep gray matter atrophy, especially thalamic atrophy. This relationship has not been studied in the clinically isolated syndrome (CIS). The aims of this study were to assess cognitive deficits in patients with CIS and relapsing-remitting multiple sclerosis (RRMS) using neuropsychological testing, to search for thalamic atrophy on brain MRI, and to test for their correlations. Methods: Forty-three patients (19 with CIS and 24 with RRMS) underwent brain MRI and neuropsychological testing involving multiple cognitive domains and the severity of depression. Thalamic volumes automatically segmented from MRI data were compared to 19 healthy controls. Correlations were sought between cognitive performance and thalamic volume. Results: Cognitive impairment was detected in the majority of both CIS and MS patients, most affected in executive functions, auditory memory, lexical verbal fluency, distribution of attention and psychomotor speed. Cognitive impairment and depression were not significantly correlated to disease duration. Both CIS and MS patients demonstrated thalamic atrophy compared to controls, while many cognitive deficits correlated with thalamic volume in both patient groups. Conclusion: Cognitive deficits in CIS resemble those found in the later stages of MS and may be directly related to the amount of thalamic damage. © 2014 Elsevier B.V. All rigths reserved.


This report illustrates the rare rapid spontaneous redistribution of an acute intracranial supratentorial subdural hematoma (AISSDH) to the entire spinal subdural space (SSS). The study is also unique in that the spinal subdural hematoma (SSH) manifested by the extremely rare Pourfour du Petit Syndrome (PPS).A 66-year-old man sustained blunt head trauma. On admission to the regional hospital, he scored 6 on GCS and his pupils were of equal size reacting to light. Initial computed tomography (CT) scan showed a unilateral AISSDH. The patient was referred to our department and arrived 16 h following the accident, at which time a repeat CT scan revealed almost complete resolution of the AISSDH without clinical improvement. On the 9th postinjury day transient anisocoria and tachycardia without spinal symptomatology developed. Since neither neurological examination nor follow-up CT scans showed intracranial pathology explaining the anisocoria, the patient was treated further conservatively. During the next 3 days circulatory instability developed and the patient succumbed to primary traumatic injury. Autopsy revealed a SSH occupying the entire SSS.This case calls attention to the unique combination of the displacement of an AISSDH to the SSS and the presentation of this clinical entity by the PPS.

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