Bansch D.,University of Rostock |
Bonnemeier H.,University of Kiel |
Brandt J.,Skane University Hospital |
Bode F.,University of Lubeck |
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. Source
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. Source
Arbelo E.,Thorax Institute |
Brugada J.,Thorax Institute |
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. Source
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. Source
Nemec P.,Masaryk University |
Zemanova Z.,General University Hospital |
Kuglik P.,Masaryk University |
Michalova K.,General University Hospital |
And 17 more authors.
Leukemia and Lymphoma | Year: 2012
The prognostic impact of chromosomal abnormalities was evaluated by fluorescence in situ hybridization with cytoplasmic immunoglobulin light chain staining (cIg-FISH) and by classical metaphase cytogenetics in a cohort of 207 patients with newly diagnosed multiple myeloma who were treated with high-dose therapy followed by autologous stem cell transplantation in the CMG2002 clinical trial. The incidence of chromosomal abnormalities detected by FISH was as follows: 52.7% for del(13)(q14), 6.5% for del(17)(p13), 18.6% for t(11;14)(q13;q32), 22.8% for t(4;14)(p16;q32) and 45.7% for gain(1)(q21). Metaphase cytogenetic analysis revealed a complex karyotype in 19.1% and hyperdiploidy in 21.7% of patients. The overall response rate was not influenced by the presence of any studied chromosomal abnormality. Patients with a complex karyotype, those with translocation t(4;14) and those with gain of the 1q21 locus had a shorter time to progression (TTP) and overall survival (OS). Other genomic changes such as translocation t(11;14) and del(13q) had less impact on TTP and OS. In multivariate analysis, complex karyotype, translocation t(4;14) and β 2-microglobulin level > 2.5 mg/L were independent prognostic factors associated with poor overall survival. Their unfavorable prognostic impact was even more pronounced if they were present in combination. Patients with t(4;14) present together with a complex karyotype had the worst prognosis, with a median OS of only 13.2 months, whereas patients with a normal karyotype or karyotype with ≤ 2 chromosomal changes had the best outcome, with 3-year OS of 85.9%. In conclusion, complex karyotype, gain of 1q21 region and translocation t(4;14) are major prognostic factors associated with reduced survival of patients with newly diagnosed multiple myeloma treated with autologous stem cell transplantation. © 2012 Informa UK, Ltd. Source