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  • Aronsson, Mattias, et al. (author)
  • The cost-effectiveness of radiofrequency catheter ablation as first-line treatment for paroxysmal atrial fibrillation : results from a MANTRA-PAF substudy.
  • 2015
  • In: Europace. - : Oxford University Press (OUP). - 1099-5129 .- 1532-2092. ; 17:1, s. 48-55
  • Journal article (peer-reviewed)abstract
    • AIM: The aim of this prospective substudy was to estimate the cost-effectiveness of treating paroxysmal atrial fibrillation (AF) with radiofrequency catheter ablation (RFA) compared with antiarrhythmic drugs (AADs) as first-line treatment.METHODS AND RESULTS: A decision-analytic Markov model, based on MANTRA-PAF (Medical Antiarrhythmic Treatment or Radiofrequency Ablation in Paroxysmal Atrial Fibrillation) study data, was developed to study long-term effects and costs of RFA compared with AADs as first-line treatment. Positive clinical effects were found in the overall population, a gain of an average 0.06 quality-adjusted life years (QALYs) to an incremental cost of €3033, resulting in an incremental cost-effectiveness ratio of €50 570/QALY. However, the result of the subgroup analyses showed that RFA was less costly and more effective in younger patients. This implied an incremental cost-effectiveness ratio of €3434/QALY in ≤50-year-old patients respectively €108 937/QALY in >50-year-old patients.CONCLUSION: Radiofrequency catheter ablation as first-line treatment is a cost-effective strategy for younger patients with paroxysmal AF. However, the cost-effectiveness of using RFA as first-line therapy in older patients is uncertain, and in most of these AADs should be attempted before RFA (MANTRA-PAF ClinicalTrials.gov number; NCT00133211).
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  • Barmano, Neshro, et al. (author)
  • Predictors of improvement in arrhythmia-specific symptoms and health-related quality of life after catheter ablation of atrial fibrillation
  • 2018
  • In: Clinical Cardiology. - : John Wiley & Sons. - 0160-9289 .- 1932-8737. ; 42:2, s. 247-255
  • Journal article (peer-reviewed)abstract
    • Background: The primary goal of radiofrequency ablation (RFA) of atrial fibrillation (AF) is to improve symptoms and health-related quality of life (HRQoL). However, most studies have focused on predictors of AF recurrence rather than on predictors of improvement in symptoms and HRQoL.Hypothesis: We sought to explore predictors of improvement in arrhythmia-specific symptoms and HRQoL after RFA of AF, and to evaluate the effects on symptoms, HRQoL, anxiety, and depression. Methods: We studied 192 patients undergoing their first RFA of AF. The Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36), arrhythmia-specific questionnaire in tachycardia and arrhythmia (ASTA), and hospital anxiety and depression scale (HADS) questionnaires were filled out at baseline, at 4 months, and at a 1-year follow-up.Results: All questionnaire scale scores improved significantly over time. In the ASTA symptom scale score, female gender and > 10 AF episodes the month before RFA were significant positive predictors of improvement, while diabetes and AF recurrence within 12 months after RFA were significant negative predictors (R2 = 0.18; P < 0.001). In the ASTA HRQoL scale score, the presence of heart failure and > 10 AF episodes the month before RFA were significant positive predictors of improvement, while diabetes, maximum left atrial volume and AF recurrence were significant negative predictors (R2 = 0.20; P < 0.001).Conclusion: Left atrial volume, gender, diabetes, heart failure, the frequency of AF attacks prior to RFA, and recurrence of AF after RFA were significant factors affecting improvement in symptoms and HRQoL after RFA of AF. Future studies are warranted to confirm these findings. 
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  • Barmano, Neshro, et al. (author)
  • Structured care of patients with atrial fibrillation improves guideline adherence
  • 2016
  • In: Journal of Atrial Fibrillation. - : CardioFront LLC. - 1941-6911. ; 9:4
  • Journal article (peer-reviewed)abstract
    • There are many reports of lack of guideline adherence in the treatment of patients with atrial fibrillation (AF), and AF affects health-related quality of life (HRQo L) negatively. The aim of this study was to investigate whether structured care compared to standard care of a general AF population could improve guideline adherence and HRQo L, and reduce symptoms, anxiety and depression. In total, 176 patients were recruited to the intervention and 146 patients to the control group. The intervention consisted of a structured follow-up program, while patients serving as controls received standard care. The primary outcome was guideline adherence evaluated through: appropriate use of oral anticoagulants (OAC) and antiarrhythmics, whether echocardiogram and thyroid lab tests were performed, and patient-reported outcome measures (PROMs), assessed with the questionnaires SF-36, EQ-5D, HADS and ASTA at baseline and after one year Guideline adherence was significantly better in the intervention group, 91% vs. 63% (p < 0.01), mainly due to appropriate OAC treatment 94% vs. 74% (p < 0.01). Symptoms assessed with ASTA were less frequent and the negative impact of AF was reduced in the intervention group after one year/at follow-up. Five scales in SF-36, and the visual analogue scale for current health status in EQ-5D (EQ-VAS), improved significantly in both groups. Structured care of patients with AF significantly improved guideline adherence and patients reported fewer symptoms and a reduced negative impact on disease-specific HRQo L compared to standard care at one year follow-up.
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  • Barmano, Neshro, 1980-, et al. (author)
  • Structured care of patients with atrial fibrillation improves guideline adherence
  • 2016
  • In: Journal of Atrial Fibrillation. - Overland Park, KS, United States : CardioFront LLC. - 1941-6911. ; 9:4
  • Journal article (peer-reviewed)abstract
    • There are many reports of lack of guideline adherence in the treatment of patients with atrial fibrillation (AF), and AF affects health-related quality of life (HRQoL) negatively. The aim of this study was to investigate whether structured care compared to standard care of a general AF population could improve guideline adherence and HRQoL, and reduce symptoms,anxiety and depression.MethodsIn total, 176 patients were recruited to the intervention and 146 patients to the control group.The intervention consisted of a structured follow-up program, while patients serving as controls received standard care. The primary outcome was guideline adherence evaluated through: appropriate use of oral anticoagulants (OAC) and antiarrhythmics, whether echocardiogram and thyroid lab tests were performed, and patient-reported outcome measures (PROMs), assessed with the questionnaires SF-36, EQ-5D, HADS and ASTA at baseline and after one year.ResultsGuideline adherence was significantly better in the intervention group, 91% vs. 63% (p < 0.01), mainly due to appropriate OAC treatment 94% vs. 74% (p < 0.01). Symptoms assessed with ASTA were less frequent and the negative impact of AF was reduced in the intervention group after one year/ at follow-up. Five scales in SF-36, and the visual analogue scale for current health status in EQ-5D (EQ-VAS), improved significantly in both groups.ConclusionStructured care of patients with AF significantly improved guideline adherence and patients reported fewer symptoms and a reduced negative impact on disease-specific HRQoL compared to standard care at one year follow-up.
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  • Barmano, Neshro, 1980- (author)
  • Structured management, Symptoms, Health-related Quality of Life and Alcohol in Patients with Atrial Fibrillation
  • 2019
  • Doctoral thesis (other academic/artistic)abstract
    • Atrial fibrillation (AF) is the most common cardiac arrhythmia, affecting at least 2.9 % of the Swedish population. Although AF is associated with increased risk of ischaemic stroke, there have been many reports on the underuse of oral anticoagulants (OAC) and non-adherence to guidelines in other areas as well. AF is also associated with disabling symptoms and decreased health-related quality of life (HRQoL), but some patients are asymptomatic. The reasons for the great variation of symptoms remain unclear. Furthermore, although research on AF has increased, studies have mainly focused on treatment, while studies on risk factors, such as alcohol consumption, have only recently gained attention.The aim of this thesis was to investigate whether structured care of patients with AF could improve guideline adherence and HRQoL compared to standard care, and to determine which factors affect symptoms and HRQoL prior to treatment with radiofrequency catheter ablation (RFA), as well as improvement after RFA. Furthermore, we aimed to examine the associations of alcohol consumption with cardiac biomarkers, the size of the left atrium (LA), and re-ablation.This thesis is based on two studies. In the ‘Structured Management and Coaching – Patients with Atrial Fibrillation’ (SMaC-PAF) study, 176 patients were recruited to the intervention group, receiving a structured follow-up programme, and 146 patients were recruited to the control group, receiving standard care. The two groups were compared in regard to adherence to guidelines and patient-reported outcome measures (PROMs) assessing symptoms and HRQoL.In the ‘Symptom burden, Metabolic profile, Ultrasound findings, Rhythm, neurohormonal activation, haemodynamics and health-related quality of life in patients with atrial Fibrillation’ (SMURF) study, 192 patients referred for their first RFA of AF were included. PROMs questionnaires were filled out, echocardiography was performed, and cardiac biomarkers were analysed. Alcohol consumption was assessed through interview and through analysis of ethyl glucuronide in hair (hEtG). AF recurrence and re-ablation within 12 months were examined.In the first study, after one year, 94% (n=112) and 74% (n=87) of patients with indication for OAC in the intervention and the control groups, respectively, actually received treatment with OAC (p <0.01). Both groups improved in anxiety and HRQoL scores over the year, but in the intervention group, arrhythmia-specific symptoms were less frequently experienced and the SF-36 scores were more similar to the norm population.In the second study, the most important predictors of arrhythmia-related symptoms and HRQoL prior to RFA were anxiety, depression and low-grade inflammation, while frequent AF attacks prior to RFA, freedom from AF recurrence after RFA, female gender, no enlarged LA, absence of diabetes, and the presence of heart failure were significant predictors of improvement in symptoms and HRQoL after RFA. Men with hEtG ≥7 pg/mg had higher levels of cardiac biomarkers, larger LA volumes and a higher re-ablation rate than men with hEtG <7 pg/mg, while no such findings were present in women.In conclusion, structured management was superior to standard care in patients with AF, emphasising the importance of structured care, adjusted to local requirements, in order to improve the care and well-being of patients with AF. Although the reasons for the great variety of symptoms in patients with AF still are not yet fully understood, it seems that psychological factors and inflammation play a role, and that improvement in symptoms and HRQoL after RFA is influenced by gender, diabetes, heart failure, LA size and the frequency of attacks before, as well as freedom from AF after, RFA. Finally, alcohol consumption corresponding to hEtG ≥7 pg/mg was associated with higher levels of cardiac biomarkers, larger LA size and a higher rate of re-ablation in men, implying that men with an hEtG-value ≥7 pg/mg have a higher risk for LA remodelling that could potentially lead to a deterioration of the AF situation.
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  • Barmano, Neshro, 1980-, et al. (author)
  • The association between alcohol consumption, cardiac biomarkers, left atrial size and re-ablation in patients with atrial fibrillation referred for catheter ablation
  • 2019
  • In: PLOS ONE. - San Francisco, CA, United States : Public Library of Science. - 1932-6203. ; 14:4
  • Journal article (peer-reviewed)abstract
    • BackgroundInformation on alcohol consumption in patients undergoing radiofrequency ablation (RFA) of atrial fibrillation (AF) is often limited by the reliance on self-reports. The aim of this study was to describe the long-term alcohol consumption, measured as ethyl glucuronide in hair (hEtG), in patients undergoing RFA due to AF, and to examine potential associations with cardiac biomarkers, left atrial size and re-ablation within one year after the initial RFA.MethodsThe amount of hEtG was measured in patients referred for RFA, and a cut-off of 7 pg/mg was used. N-terminal pro B-type natriuretic peptide (NT-proBNP) and the mid-regional fragment of pro atrial natriuretic peptide (MR-proANP) were examined and maximum left atrium volume index (LAVI) was measured. The number of re-ablations was examined up to one year after the initial RFA. Analyses were stratified by gender, and adjusted for age, systolic blood pressure, body mass index, presence of heart failure and heart rhythm for analyses regarding NT-proBNP, MR-proANP and LAVI and heart rhythm being replaced by type of AF for analyses regarding re-ablation.ResultsIn total, 192 patients were included in the study. Median (25th– 75th percentile) NT-proBNP in men with hEtG ≥ 7 vs. < 7 pg/mg was 250 (96–695) vs. 130 (49–346) pg/ml (p = 0.010), and in women it was 230 (125–480) vs. 230 (125–910) pg/ml (p = 0.810). Median MR-proANP in men with hEtG ≥ 7 vs. < 7 pg/mg was 142 (100–224) vs. 117 (83–179) pmol/l (p = 0.120) and in women it was 139 (112–206) vs. 153 (93–249) pmol/l (p = 0.965). The median of maximum LAVI was 30.1 (26.7–33.9) vs. 25.8 (21.4–32.0) ml/m2 (p = 0.017) in men, and 25.0 (18.9–29.6) vs. 25.7 (21.7–34.6) ml/m2 (p = 0.438) in women, with hEtG ≥ 7 vs. < 7 pg/ml, respectively. Adjusted analyses showed similar results, except for MR-proANP turning out significant in men with hEtG ≥ 7 vs. < 7 pg/mg (p = 0.047). The odds ratio of having a re-ablation was 3.5 (95% CI 1.3–9.6, p = 0.017) in men with hEtG ≥ 7 vs. < 7 pg/mg, while there was no significant difference in women.ConclusionsIn male patients with AF and hEtG ≥ 7 pg/mg, NT-proBNP and MR-proANP were higher, LA volumes larger, and there was a higher rate of re-ablations, as compared to men with hEtG < 7 pg/mg. This implies that men with an alcohol consumption corresponding to an hEtG-value ≥ 7, have a higher risk for LA remodelling that could potentially lead to a deterioration of the AF situation.
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  • Charitakis, Emmanouil, et al. (author)
  • Symptom burden, Metabolic profile, Ultrasound findings, Rhythm, neurohormonal activation, haemodynamics and health-related quality of life in patients with atrial Fibrillation (SMURF) : a protocol for an observational study with a randomised interventional component
  • 2015
  • In: BMJ Open. - : BMJ Publishing Group. - 2044-6055. ; 5:12
  • Journal article (peer-reviewed)abstract
    • INTRODUCTION: Atrial fibrillation (AF) is the most common cardiac arrhythmia, with an estimated prevalence of 1.5-2%. It is an independent risk factor for ischaemic stroke and is estimated to cause about 20-25% of all stroke cases. AF has a great impact on health-related quality of life (HRQoL); however, one unresolved issue related to AF is the wide variation in its symptoms.METHODS AND ANALYSIS: The symptom burden, metabolic profile, ultrasound findings, rhythm, neurohormonal activation, haemodynamics and HRQoL in patients with AF (Symptom burden, Metabolic profile, Ultrasound findings, Rhythm, neurohormonal activation, haemodynamics and health-related quality of life in patients with atrial Fibrillation, SMURF) study is a prospective observational, cohort study, with a randomised interventional part. The aim of the study is to investigate, in patients with AF, the relationship between symptom burden and metabolic aspects, atrial function and different neurohormones, and the effect of radiofrequency ablation (RFA). The interventional part of the study will give an insight into the neurohormonal and intracardiac pressure changes directly after initiation of AF. Consecutive patients with symptomatic AF accepted for treatment with RFA for the first time at Linköping University Hospital are eligible for participation. The enrolment started in January 2012, and a total of 200 patients are to be included into the study, with 45 of them being enrolled into the interventional study with initiation of AF. The sample size of the interventional study is based on a small pilot study with 5 patients induced to AF while 2 served as controls. The results indicated that, in order to find a statistically significant difference, there was a need to include 28 patients; for safety reasons, 45 patients will be included.ETHICS AND DISSEMINATION: The SMURF study is approved by the Regional Ethical Review Board at the Faculty of Health Sciences, Linköping, Sweden. The results will be presented through peer-review journals and conference presentation.TRIAL REGISTRATION NUMBER: NCT01553045; Pre-results.
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  • Walfridsson, Håkan, et al. (author)
  • Radiofrequency ablation as initial therapy in paroxysmal atrial fibrillation: results on health-related quality of life and symptom burden. The MANTRA-PAF trial
  • 2015
  • In: Europace. - : Oxford University Press (OUP): Policy B - Oxford Open Option B - CC-BY. - 1099-5129 .- 1532-2092. ; 17:2, s. 215-221
  • Journal article (peer-reviewed)abstract
    • Aims The Medical ANtiarrhythmic Treatment or Radiofrequency Ablation in Paroxysmal Atrial Fibrillation (MANTRA-PAF) trial assessed the long-term efficacy of an initial strategy of radiofrequency ablation (RFA) vs. antiarrhythmic drug therapy (AAD) as first-line treatment for patients with PAF. In this substudy, we evaluated the effect of these treatment modalities on the Health-Related Quality of Life (HRQoL) and symptom burden of patients at 12 and 24 months. Methods and results During the study period, 294 patients were enrolled in the MANTRA-PAF trial and randomized to receive AAD (N = 148) or RFA (N = 146). Two generic questionnaires were used to assess the HRQoL [Short Form-36 (SF-36) and EuroQol-five dimensions (EQ-5D)], and the Arrhythmia-Specific questionnaire in Tachycardia and Arrhythmia (ASTA) was used to evaluate the symptoms appearing during the trial. All comparisons were made on an intention-to-treat basis. Both randomization groups showed significant improvements in assessments with both SF-36 and EQ-5D, at 24 months. Patients randomized to RFA showed significantly greater improvement in four physically related scales of the SF-36. The three most frequently reported symptoms were breathlessness during activity, pronounced tiredness, and worry/anxiety. In both groups, there was a significant reduction in ASTA symptom index and in the severity of seven of the eight symptoms over time. Conclusion Both AAD and RFA as first-line treatment resulted in substantial improvement of HRQoL and symptom burden in patients with PAF. Patients randomized to RFA showed greater improvement in physical scales (SF-36) and the EQ-visual analogue scale.
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  • Walfridsson, Ulla, et al. (author)
  • Gender and age differences in symptoms and health-related quality of life in patients with atrial fibrillation referred for catheter ablation
  • 2019
  • In: Pacing and Clinical Electrophysiology. - : John Wiley & Sons. - 0147-8389 .- 1540-8159. ; 42:11, s. 1431-1439
  • Journal article (peer-reviewed)abstract
    • Background: Primary indication for catheter ablation of atrial fibrillation (AF) is to reduce symptoms and improve health-related quality of life (HRQoL). There are data showing differences between the genders and between younger and older patients. To evaluate this, we studied a large Scandinavian cohort of patients referred for catheter ablation of AF.Methods: Consecutive patients filled out the ASTA questionnaire, assessing symptoms, HRQoL, and perception of arrhythmia, prior to ablation. Patients were recruited from four Swedish and one Danish tertiary center.Results: A total of 2493 patients (72% men) filled out the ASTA questionnaire. Women experienced eight of the nine ASTA scale symptoms more often than men. Patients <65 years reported four symptoms more often, only tiredness was more frequent in those >= 65 years (P = .007). Women and patients <65 years experienced more often palpitations and regarding close to fainting and this was more common among women, no age differences were seen. Women and men scored differently in 10 of the 13 HRQoL items. Only negative impact on sexual life was more common in men (P < .001). Older patients reported more negative influence in four of the HRQoL items and the younger in one; ability to concentrate.Conclusions: Women experienced a more pronounced symptom burden and were more negatively affected in all HRQoL concerns, except for the negative impact on sexual life, where men reported more influence of AF. Differences between age groups were less pronounced. Disease-specific patient-reported outcomes measures (PROMs) add important information where gender differences should be considered in the care.
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  • Walfridsson, Ulla, et al. (author)
  • Impact of radiofrequency ablation on health-related quality of life in patients with paroxysmal supraventricular tachycardia compared with a norm population one year after treatment.
  • 2011
  • In: Heart & Lung. - : Elsevier BV. - 0147-9563 .- 1527-3288. ; 40:5, s. 405-411
  • Journal article (peer-reviewed)abstract
    • OBJECTIVE: This study evaluated the impact of radiofrequency ablation (RFA) on health-related quality of life (HRQOL) in patients with paroxysmal supraventricular tachycardia (PSVT).METHODS: HRQOL was assessed with the Short Form-36 Health Survey (SF-36) and EuroQol (EQ)-5D at baseline and 3 and 12 months after RFA. At 12 months, the patients were compared with an age- and gender-matched reference group.RESULTS: Patients showed a marked improvement in all the SF-36's scales at 3 months after treatment compared with baseline. Patients scored higher in all scales in the SF-36 but not in the EQ-5D's index at 12 months compared with baseline. No further improvements were detected from 3 to 12 months follow-up. Twelve months after treatment, patients scored equal to the reference group in the SF-36 and EQ-5D index, indicating a complete restoration of the HRQOL after RFA.CONCLUSION: PSVT is a condition with a pronounced impact on HRQOL. At 12 months follow-up after RFA, patients' HRQOL scores were similar to those of the age- and gender-matched reference group.
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  • Walfridsson, Ulla, et al. (author)
  • Symptoms and health-related quality of life 5 years after catheter ablation of atrial fibrillation
  • 2022
  • In: Clinical Cardiology. - : Wiley. - 0160-9289 .- 1932-8737. ; 45:1, s. 42-50
  • Journal article (peer-reviewed)abstract
    • Objectives To investigate the effect of catheter ablation (CA) on symptoms and health-related quality of life (HRQoL) after 5 years, and analyze predictors of recurrence of symptoms. Background The primary indication for CA of atrial fibrillation (AF) is to reduce symptoms and improve HRQoL where long-term follow-up are sparse. Methods In this observational, long-term, single-center study, patients were recruited from Linkoping University Hospital, Sweden. They were aged >= 18 years and had been referred for CA from November 2011 until June 2019. Arrhythmia-specific symptoms and HRQoL were assessed by patient-reported outcome measures (PROMs) with the Arrhythmia-Specific questionnaire in Tachycardia and Arrhythmia (ASTA). Results In the study were 1521 patients, 69% men, mean age 62 years. At baseline, 87% of the patients and at the 5-year follow-up 80% of those eligible filled out the ASTA questionnaire. At follow-up, 50% reported freedom from symptoms, 18% had >50% symptom reduction, 14% had a minor reduction, while 18% reported no effect or a worsening of symptoms. Factors predicting symptoms were female gender (hazard ratio [HR]: 1.8; 1.2-2.8), body mass index >= 35 (HR: 3.9; 1.6-9.8), and ischemic heart disease (IHD) (HR: 2.6; 1.2-5.9). After 5 years, breathlessness during activity, weakness/fatigue, and tiredness were still the most common symptoms; regarding HRQoL they were impaired physical ability and deteriorated life situation. Conclusions and Clinical Implications This clinical cohort of patients with AF evaluated through PROMs showed that CA had long-lasting effects on symptoms and HRQoL and that the use of PROMs in clinical routines was feasible. Factors predicting symptoms after CA were female gender, IHD, and obesity, an important reminder to encourage lifestyle management.
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  • Walfridsson, Ulla, et al. (author)
  • The impact of supraventricular tachycardias on driving ability in patients referred for radiofrequency catheter ablation
  • 2005
  • In: Pacing and Clinical Electrophysiology. - : Wiley. - 0147-8389 .- 1540-8159. ; 28:3, s. 191-195
  • Journal article (peer-reviewed)abstract
    • Aim: The aim of the present study was to evaluate the occurrence of arrhythmia-related symptoms in patients with supraventricular tachycardia (SVT) referred for radiofrequency catheter ablation (RF ablation) with special focus on driving ability. Methods and Results: Of the 301 patients referred for RF ablation between November 1998 and December 2000 due to SVT 226 were active drivers. The present study is an interview study with structured questions. Hemodynamic symptoms were frequently encountered during tachycardia. The symptoms occurred irrespective of driving. In the 226 active drivers, fatigue was reported in 77%, dizziness in 47%, breaking into a cold sweat in 52%, near-syncope in 50%, and syncope in 14%. Women experienced all symptoms more frequently than men: fatigue (P < 0.05), dizziness (P < 0.01), cold sweat (P < 0.05), near-syncope (P < 0.001), and syncope (P < 0.01). Fifty-seven percent of the patients had experienced tachycardia while driving, and 42% of those patients had to stop because of it. Twenty-four of all patients considered their tachycardia as an obstacle to driving. There was a significant correlation (P < 0.001) between having experienced near-syncope and considering the risk for tachycardia as an obstacle. Conclusions: SVT frequently occurs during driving and is often associated with hemodynamic symptoms including near-syncope and syncope. Women reported tachycardia-related hemodynamic symptoms more often than men. There is a correlation between having experienced near-syncope and considering tachycardia as an obstacle to driving. The risk for serious tachycardia-related symptoms should be considered, especially in occupational drivers.
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  • Walfridsson, Ulla, et al. (author)
  • Validation of the English version of the arrhythmia-specific questionnaire in tachycardia and arrhythmia (ASTA) : a Rasch evaluation study
  • 2022
  • In: Journal of Patient-Reported Outcomes. - : Springer. - 2509-8020. ; 6:1
  • Journal article (peer-reviewed)abstract
    • Background: Patient-reported outcome measures are important in person-centered care, providing valuable information about patients’ experiences. Disease-specific questionnaires add important information about a certain disease in comparison to generic questionnaires. Questionnaires need to be validated in the targeted population to achieve reliable data. The purpose with the study was to use Rasch measurement theory to evaluate the English version of the ASTA questionnaire. Methods: The Rasch model theory was used to evaluate global and item fit, targeting, response category functioning, local independency, unidimensionality, differential item functioning (DIF) for gender and age, and reliability. Results: The study included 202 patients undergoing DC conversion or catheter ablation at the Centre for Heart Rhythm Disorders at the University of Adelaide, Australia. The mean age was 67 years and 30% were women. Most patients had atrial fibrillation (n = 179), others had atrial flutter or had a combination. One of nine items demonstrated unsatisfactory model fit in the ASTA Symptom scale and two of 13 in the ASTA Health-Related Quality of Life (HRQoL) scale. Unidimensionality was supported for both scales. The targeting was acceptable except for the lower end of the scales. Both scales showed reversed thresholds for the response categories “quite a lot” and “a lot” (eight of ASTA symptoms and 12 of ASTA HRQoL items). Some problems with local dependency were detected in both scales. The reliability (person separation index) was satisfactory: 0.75 for the ASTA symptom scale and 0.77 for the ASTA HRQoL scale. No DIF for gender and age were detected. Conclusions: The English version of the ASTA questionnaire demonstrated satisfactory measurement properties according to the Rasch model. However, it needs to be evaluated in patients with other arrhythmias. The response categories should be considered as well as DIF in further validation. The ASTA questionnaire can be used for assessments of symptoms and HRQoL between groups of different ages and genders in patients with arrhythmia. © 2022, The Author(s).
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  • Walfridsson, Ulla, et al. (author)
  • Wolff-Parkinson-White Syndrome and Atrioventricular Nodal Re-Entry Tachycardia in a Swedish Population: Consequences on Health-Related Quality of Life
  • 2009
  • In: Pacing and Clinical Electrophysiology. - : Wiley. - 0147-8389 .- 1540-8159. ; 32:10, s. 1299-1306
  • Journal article (peer-reviewed)abstract
    • Background: Living with paroxysmal supraventricular tachycardia affects a patient's whole life situation, but few studies have addressed health-related quality of life (HRQOL) aspects in these patients. The aim was therefore to describe HRQOL in patients with atrioventricular nodal re-entry tachycardia (AVNRT) or Wolff-Parkinson-White (WPW) syndrome, referred for radiofrequency ablation (RF-ablation), compared to age- and gender-matched Swedish reference groups. Methods: HRQOL was assessed with SF-36 and EuroQol (EQ-5D and EQ-VAS) and the patients were asked disease-specific questions. Results: The 97 patients with AVNRT [53 ± 16 years of age/65 women] and 79 patients with WPW [42 ± 15 years of age/26 women] exhibited significantly lower HRQOL scores in SF-36 in the same seven of the eight scales: Physical functioning (PF), role-physical (RP), social functioning (SF), role-emotional (RE), general health (GH), vitality (VT), and mental health (MH) while there was no difference in bodily pain (BP) compared to their respective age- and gender matched Swedish reference group. HRQOL scores were lower for patients with AVNRT compared to WPW in the areas of PF (P < 0.001), BP (P < 0.05), and GH (P < 0.01) in SF-36, and the same was found in EQ-VAS (64.8 vs. 71.2, P < 0.05). Occurrence of episodes of tachycardia more often than once a month compared to less frequently than once a month was associated with significantly lower HRQOL in all eight scales in SF-36 (GH, RE, MH: P < 0.01 and PF, RP, BP, VT, SF: P < 0.001) and EQ-5D index (P < 0.001) and EQ-VAS (P < 0.05) Arrhythmia duration longer than one hour compared to patients with shorter duration of the tachycardia-affected GH in SF-36 negatively (P < 0.05). Patients who experienced symptoms not only during activity but also at rest scored lower in SF-36 GH (P < 0.01) and SF (P < 0.05). Conclusion: Measuring HRQOL in patients with WPW or AVNRT is an important way to evaluate and describe these patients' life situation. These conditions were found to have a pronounced negative impact on HRQOL. The frequency of arrhythmia occurrence is one important factor to consider when setting priorities for treatment with RF-ablation.
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  • Alhede, Christina, et al. (author)
  • Antiarrhythmic medication is superior to catheter ablation in suppressing supraventricular ectopic complexes in patients with atrial fibrillation
  • 2017
  • In: International Journal of Cardiology. - : ELSEVIER IRELAND LTD. - 0167-5273 .- 1874-1754. ; 244, s. 186-191
  • Journal article (peer-reviewed)abstract
    • Background: Supraventricular ectopic complexes (SVEC) originating in the pulmonary veins are known triggers of atrial fibrillation (AF) which led to the development of pulmonary vein isolation for AF. However, the long-term prevalence of SVEC after catheter ablation (CA) as compared to antiarrhythmic medication (AAD) is unknown. Our aims were to compare the prevalence of SVEC after AAD and CA and to estimate the association between baseline SVEC burden and AF burden during 24 months of follow-up. Methods: Patients with paroxysmal AF (N = 260) enrolled in the MANTRA PAF trial were treated with AAD (N = 132) or CA (N = 128). At baseline and 3, 6, 12, 18 and 24 months follow-up patients underwent 7-day Holter monitoring to assess SVEC and AF burden. We compared SVEC burden between treatments with Wilcoxon sum rank test. Results: Patients treated with AAD had significantly lower daily SVEC burden during follow-up as compared to CA (AAD: 19 [6-58] versus CA: 39 [14-125], p = 0.003). SVEC burden increased post-procedurally followed by a decrease after CA whereas after AAD SVEC burden decreased and stabilized after 3 months of follow-up. Patients with low SVEC burden had low AF burden after both treatments albeit this was more pronounced after CA at 24 months of follow-up. Conclusion: AAD was superior to CA in suppressing SVEC burden after treatment of paroxysmal AF. After CA SVEC burden increased immediately post-procedural followed by a decrease whereas after AAD an early decrease was observed. Lower SVEC burden was highly associated with lower AF burden during follow-up especially after CA. (C) 2017 Elsevier B.V. All rights reserved.
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26.
  • Alhede, Christina, et al. (author)
  • Higher burden of supraventricular ectopic complexes early after catheter ablation for atrial fibrillation is associated with increased risk of recurrent atrial fibrillation
  • 2018
  • In: Europace. - : OXFORD UNIV PRESS. - 1099-5129 .- 1532-2092. ; 20:1, s. 50-57
  • Journal article (peer-reviewed)abstract
    • Aims Early identification of patients who could benefit from early re-intervention after catheter ablation is highly warranted. Our aim was to investigate the association between post-procedural burden of supraventricular ectopic complexes (SVEC) and the risk of long-term atrial fibrillation (AF) recurrence. Methods and results A total of 125 patients undergoing catheter ablation for AF were included. Patients underwent 7-day Holter recordings immediately post-procedural. The number of SVEC in post-procedural Holter recordings was categorized into quartiles: 0-72, 73-212, 213-782 and amp;gt;= 783 SVEC/day. Long-term AF recurrence was defined as a combined endpoint of AF amp;gt;= 1 min during follow-up Holter recordings, cardioversion or hospitalization for AF after a 3-month blanking period and within 24 months of follow-up. High post-procedural supraventricular ectopy burden was associated with an increased risk of long-term AF recurrence in a dose-dependent manner (amp;gt;= 783 SVEC: HR 4.6 [1.9-11.5], P amp;lt; 0.001) irrespective of AF recurrence during the blanking period or other risk factors. In patients with early AF recurrence amp;lt; 90 days after catheter ablation ectopy burden was also highly predictive of long-term AF recurrence (SVEC amp;gt;= 213: HR 3.0 [1.3-6.7], P = 0.007). Correspondingly, patients with early AF recurrence but low ectopy burden remained at low risk of long-term AF recurrence after the blanking period. Conclusion Our results indicate that post-procedural ectopy burden is highly associated with long-term AF recurrence and could be a potent risk marker for selection of patients for early re-ablation. Development of future ablation risk stratification and strategies should include focus on post-procedural ectopy burden.
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27.
  • Alhede, Christina, et al. (author)
  • The impact of supraventricular ectopic complexes in different age groups and risk of recurrent atrial fibrillation after antiarrhythmic medication or catheter ablation
  • 2018
  • In: International Journal of Cardiology. - : ELSEVIER IRELAND LTD. - 0167-5273 .- 1874-1754. ; 250, s. 122-127
  • Journal article (peer-reviewed)abstract
    • Introduction: Supraventricular ectopic complexes (SVEC) are known risk factors of recurrent atrial fibrillation (AF). However, the impact of SVEC in different age groups is unknown. We aimed to investigate the risk of AF recurrence with higher SVEC burden in patients +/- 57 years, respectively, after treatment with antiarrhythmic medication (AAD) or catheter ablation (CA). Methods: In total, 260 patients with LVEF amp;gt;40% and age amp;lt;= 70 years were randomized to AAD (N = 132) or CA (N = 128) as first-line treatment for paroxysmal AF. All patients underwent 7-day Holter monitoring at baseline, and after 3, 6, 12, 18 and 24 months and were categorized according to median age +/- 57 years. We used multi-variate Cox regression analyses and we defined high SVEC burden at 3 months of follow-up as the upper 75th percentile amp;gt;195 SVEC/day. AF recurrence was defined as AF amp;gt;= 1 min, AF-related cardioversion or hospitalization. Results: Age amp;gt;57 years were significantly associated with higher AF recurrence rate after CA (58% vs 36%, p = 0.02). After CA, we observed a higher SVEC burden during follow-up in patients amp;gt;57 years which was not observed in the younger age group treatedwith CA (p = 0.006). High SVEC burden at 3 months after CA was associated with AF recurrence in older patients but not in younger patients (amp;gt;57 years: HR 3.4 [1.4-7.9], p = 0.005). We did not find any age-related differences after AAD. Conclusion: We found that younger and older patients respond differently to CA and that SVEC burden was only associated with AF recurrence in older patients. (C) 2017 Elsevier B.V. All rights reserved.
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28.
  • Charitakis, Emmanouil, 1982-, et al. (author)
  • Endocrine and Mechanical Cardiacfunction Four Months after Radiofrequency Ablation of Atrialfibrillation.
  • 2021
  • In: Journal of Atrial Fibrillation. - Overland Park, KS, United States : Cardiofront, Inc. - 1941-6911. ; 14:1
  • Journal article (peer-reviewed)abstract
    • Background: Radiofrequency ablation (RFA)is an important treatment option for patients with atrial fibrillation (AF). During RFA, a significant amount of energy is delivered into the left atrium (LA), resulting in considerable LA-injury. The impact of this damage on mechanical and endocrine LA-function, however, is often disregarded.We therefore aimed to evaluate the endocrine- and mechanical function of the heart 4-months after RFA of AF.Methods: In total 189 patients eligible for RFA of AF were studied. The levels of the N-terminal pro-B-natriuretic peptide (NT-proBNP) and the mid-regional fragment of the N-terminal pro-atrial natriuretic peptide (MR-proANP)were measured. The maximum LAvolume (LAVmax),the LAejection fraction (LAEF) and the LA peak longitudinal strain (PALS), were measured usingtransthoracic echocardiography. The measurements were performed before and 4-months after the intervention.Results: 87 patients had a recurrence during a mean follow-up of 143±36 days.NT-proBNPand MR-proANPdecreased significantly at follow-up. This reduction was greater in patients who did not suffer any recurrence after RFA.The LAVmax decreased significantly, whereasthe PALS only improved in patients who did not suffer from any recurrence. On the other hand, LAEF did not change significantly after RFA of AF.Conclusions: Despite extensiveablation during RFA of AF, the endocrine function of the heart improved 4-months after the index procedure. Patients with no arrhythmia recurrence showed a more pronounced improvement in their endocrinal function. Mechanically, the LAVmax was reduced, and the LA strain improved significantly.
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29.
  • Charitakis, Emmanouil, et al. (author)
  • Neurohormonal Activation After Atrial Fibrillation Initiation in Patients Eligible for Catheter Ablation: A Randomized Controlled Study
  • 2016
  • In: Journal of the American Heart Association. - : WILEY-BLACKWELL. - 2047-9980. ; 5:12
  • Journal article (peer-reviewed)abstract
    • Background-Biomarker activation in atrial fibrillation (AF) has been widely studied, but the immediate effect of AF initiation remains unclear. We studied the effect of AF initiation on 2 cardiac biomarkers: the N-terminal fragment of the proB-type natriuretic peptide (NT-proBNP), the midregional fragment of the N-terminal of pro-atrial natriuretic peptide (MR-proANP), and 2 extracardiac biomarkers-the copeptin and the midregional portion of proadrenomedullin (MR-proADM). Methods and Results-This was a randomized controlled study, including 45 patients with AF who had been referred for radiofrequency ablation to the University Hospital, Link_ oping, Sweden, between February 2012 and April 2014. Freedom from AF during the 4 days prior to radiofrequency ablation was confirmed by transtelephonic ECGs. Biomarkers were collected from the femoral vein (fv), coronary sinus (CS), and left atrium (LA) prior to AF initiation (baseline) and 30 minutes later. The MR-proANP and NT-proBNP concentrations increased in the intervention group compared with the control group 30 minutes after the initiation of AF (MR-proANP: P-fvamp;lt;0.001, P-CSamp;lt;0.001, P-LAamp;lt;0.001; NT-proBNP: P-LAamp;lt;0.001). Copeptin levels in patients without ischemic heart disease were decreased after the initiation of AF (P-fv= 0.003, P-CS= 0.015, P-LA= 0.011). Conclusions-AF is a strong stimulus that results in immediate activation of different biomarkers.
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30.
  • Charitakis, Emmanouil, 1982- (author)
  • Neurohormonal activation, Symptoms and health-related quality of life in patients with atrial fibrillation eligible for radiofrequency ablation
  • 2016
  • Doctoral thesis (other academic/artistic)abstract
    • Atrial fibrillation (AF) is the most common cardiac arrhythmia. In order to improve the management of patients with AF, a better understanding of patients’ arrhythmia-related symptoms and health-related quality of life (HRQoL), as well as a finer grasp of the effect of AF initiation and the revolutionary treatment of radiofrequency ablation (RFA) on neurohormonal balance are of great importance.The aim of this dissertation was to study the effects of RFA and AF initiation on four different neurohormonal systems represented by two cardiac biomarkers: the N-terminal fragment of the proB-type natriuretic peptide (NT-proBNP), the mid-regional fragment of the N-terminal of pro-atrial natriuretic peptide (MR-proANP); and two extra-cardiac biomarkers: the C-terminal fragment of the prodromal molecule of arginine vasopressin (copeptin) and the mid-regional portion of pro-adrenomedullin (MR-proADM). Furthermore, we aimed to correlate objective indicators with the variety of arrhythmiarelated symptoms and HRQoL in patients with AF.We studied 192 consecutive AF patients, eligible for RFA, referred to the University Hospital, Linköping, Sweden between January 2012 and April 2014. Forty-five patients, out of the initially selected sample, were included in the interventional part of the study. Biomarkers were collected from the femoral vein (fv), the coronary sinus (CS) and the left atrium (LA), and from fv immediately and the day after RFA. With regard to the interventional part of the study, 36 patients were randomized to AF initiation and 19 to control group. Biomarkers were retrieved from fv, CS and LA prior to AF initiation (baseline) and 30 minutes later. The Arrhythmia-Specific questionnaire in Tachycardia and Arrhythmia (ASTA) symptom scale was used in order to assess patients’ arrhythmiarelated symptoms. The ASTA HRQoL scale and the generic short-form 36 (SF-36) physical and mental component summaries were used in order to express patients’ disease-specific and overall HRQoL respectively.While analysing the effect of RFA on biomarkers, it was noticed that the level of NTproBNP decreased the day after RFA in participants in AF, compared with the participants in sinus rhythm who showed a slight increase. Regardless of the actual rhythm, the level of MR-proANP showed an increase immediately after RFA was carried out, followed by a decrease the day after. The copeptin level showed a six-fold increase, compared with baseline, immediately after the RFA procedure, while the MR-proADM level increased the day after. The levels of copeptin and MR-proADM were similar in the CS compared to peripheral blood.When it came to the effects of AF initiation on biomarkers, compared with the control group, MR-proANP and NT-proBNP concentrations were increased. Copeptin levels in patients without ischemic heart disease were decreased after the initiation of AF.We also found that signs of anxiety, low-grade inflammation (defined by high-sensitive C-reactive protein levels>3mg/l) and LA dilatation significantly predicted arrhythmiarelated symptoms. Probable depression was the most important predictor of arrhythmiaspecific HRQoL, and obesity and signs of anxiety were the most important predictors of the physical and mental component summaries respectively.AF is a complex arrhythmia that affects the cardiac and extra-cardiac neurohormonal balance directly after its initiation. RFA causes a neurohormonal imbalance not only due to secondary myocardial injury, but also due to other factors such as patient’s actual rhythm, volume overload and procedural stress. Treatable factors such as anxiety, depression and obesity, which can affect HRQoL and symptoms in patients with AF, should be addressed, and possibly a more intensive life style factor modification can be of value.
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31.
  • Charitakis, Emmanouil, et al. (author)
  • Risk and protective factors for atrial fibrillation after cardiac surgery and valvular interventions : an umbrella review of meta-analyses
  • 2022
  • In: Open heart. - : BMJ Publishing Group. - 2053-3624. ; 9:2
  • Research review (peer-reviewed)abstract
    • Objective Postoperative atrial fibrillation (POAF) is a common complication affecting approximately one-third of patients after cardiac surgery and valvular interventions. This umbrella review systematically appraises the epidemiological credibility of published meta-analyses of both observational and randomised controlled trials (RCT) to assess the risk and protective factors of POAF. Methods Three databases were searched up to June 2021. According to established criteria, evidence of association was rated as convincing, highly suggestive, suggestive, weak or not significant concerning observational studies and as high, moderate, low or very low regarding RCTs. Results We identified 47 studies (reporting 61 associations), 13 referring to observational studies and 34 to RCTs. Only the transfemoral transcatheter aortic valve replacement (TAVR) approach was associated with the prevention of POAF and was supported by convincing evidence from meta-analyses of observational data. Two other associations provided highly suggestive evidence, including preoperative hypertension and neutrophil/lymphocyte ratio. Three associations between protective factors and POAF presented a high level of evidence in meta-analyses, including RCTs. These associations included atrial and biatrial pacing and performing a posterior pericardiotomy. Nineteen associations were supported by moderate evidence, including use of drugs such as amiodarone, b-blockers, glucocorticoids and statins and the performance of TAVR compared with surgical aortic valve replacement. Conclusions Our study provides evidence confirming the protective role of amiodarone, b-blockers, atrial pacing and posterior pericardiotomy against POAF as well as highlights the risk of untreated hypertension. Further research is needed to assess the potential role of statins, glucocorticoids and colchicine in the prevention of POAF.
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32.
  • Charitakis, Emmanouil, et al. (author)
  • Short‐Term Influence of Radiofrequency Ablation on NT‐proBNP, MR‐proANP, Copeptin, and MR‐proADM in Patients With Atrial Fibrillation : Data From the Observational SMURF Study
  • 2016
  • In: Journal of the American Heart Association. - : Wiley-Blackwell Publishing Inc.. - 2047-9980. ; 5:9
  • Journal article (peer-reviewed)abstract
    • Background There is limited knowledge on the short‐term influence of radiofrequency ablation (RFA) of atrial fibrillation (AF) on 2 cardiac biomarkers; the N‐terminal pro‐B‐type natriuretic peptide (NT‐proBNP) and the midregional fragment of the N‐terminal of pro‐ANP (MR‐proANP) and 2 extracardiac biomarkers; the c‐terminal provasopressin (copeptin) and the midregional portion of proadrenomedullin (MR‐proADM). There are also limited data concerning cardiac production of the latter two.Methods and Results We studied 192 consecutive patients eligible for RFA of AF referred to the University Hospital, Linköping, Sweden. NT‐proBNP, MR‐proANP, copeptin, and MR‐proADM levels were measured in peripheral blood, the coronary sinus (CS), and the left atrium before ablation, and in peripheral blood immediately and the day after RFA. The level of NT‐proBNP decreased the day after RFA in participants in AF at the time of RFA, compared to the participants in sinus rhythm who showed a slight increase (P<0.001). Furthermore, regardless of the actual rhythm, the level of MR‐proANP showed an increase immediately after RFA (P<0.001), followed by a decrease the day after ablation (P<0.001). Copeptin level showed a 6‐fold increase immediately after RFA compared to baseline (P<0.001), whereas MR‐proADM level increased the day after RFA (P<0.001). Levels of copeptin and MR‐proADM were not higher in the CS compared to peripheral blood.Conclusions RFA of AF is a strong stimulus with a significant and direct impact on different neurohormonal systems. We found no sign of a cardiac release of MR‐proADM or copeptin.
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33.
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34.
  • Cosedis Nielsen, Jens, et al. (author)
  • Radiofrequency Ablation as Initial Therapy in Paroxysm Atrial Fibrillation
  • 2012
  • In: New England Journal of Medicine. - : Massachusetts Medical Society. - 0028-4793 .- 1533-4406. ; 367:17, s. 1587-1595
  • Journal article (peer-reviewed)abstract
    • BackgroundThere are limited data comparing radiofrequency catheter ablation with antiarrhythmic drug therapy as first-line treatment in patients with paroxysmal atrial fibrillation.MethodsWe randomly assigned 294 patients with paroxysmal atrial fibrillation and no history of antiarrhythmic drug use to an initial treatment strategy of either radiofrequency catheter ablation (146 patients) or therapy with class IC or class III antiarrhythmic agents (148 patients). Follow-up included 7-day Holter-monitor recording at 3, 6, 12, 18, and 24 months. Primary end points were the cumulative and per-visit burden of atrial fibrillation (i.e., percentage of time in atrial fibrillation on Holter-monitor recordings). Analyses were performed on an intention-to-treat basis.ResultsThere was no significant difference between the ablation and drug-therapy groups in the cumulative burden of atrial fibrillation (90th percentile of arrhythmia burden, 13% and 19%, respectively; P=0.10) or the burden at 3, 6, 12, or 18 months. At 24 months, the burden of atrial fibrillation was significantly lower in the ablation group than in the drug-therapy group (90th percentile, 9% vs. 18%; P=0.007), and more patients in the ablation group were free from any atrial fibrillation (85% vs. 71%, P=0.004) and from symptomatic atrial fibrillation (93% vs. 84%, P=0.01). One death in the ablation group was due to a procedure-related stroke; there were three cases of cardiac tamponade in the ablation group. In the drug-therapy group, 54 patients (36%) underwent supplementary ablation.ConclusionsIn comparing radiofrequency ablation with antiarrhythmic drug therapy as first-line treatment in patients with paroxysmal atrial fibrillation, we found no significant difference between the treatment groups in the cumulative burden of atrial fibrillation over a period of 2 years.
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35.
  • Crijns, Harry J., et al. (author)
  • Safe and effective conversion of persistent atrial fibrillation to sinus rhythm by intravenous AZD7009.
  • 2006
  • In: Heart Rhythm. - : Elsevier BV. - 1547-5271. ; 3:11, s. 1321-1331
  • Journal article (peer-reviewed)abstract
    • Background Acute drug conversion of persistent atrial fibrillation usually fails. Objectives The purpose of this study was to test the proarrhythmic potential, safety, and efficacy of the novel antiarrhythmic agent AZD7009 in patients with persistent atrial fibrillation (AF) or atrial flutter (mean duration 43 days) scheduled for direct current (DC) cardioversion. Methods Patients were randomized to AZD7009 (3-hour intravenous infusion; n = 86) or placebo (n = 36). AZD7009 was given in doses intended to produce target pseudo–steady-state plasma levels of 0.25, 0.50, 0.75, 1.0, 1.5, 2.0, or 2.5 μmol/L after 30 minutes of infusion. DC cardioversion was performed if conversion to sinus rhythm (SR) did not occur within 2 hours of infusion. Results AZD7009 in a concentration-dependent manner increased the rate of conversion of AF to SR and shortened the time to conversion. At the three highest target concentrations of AZD7009, 45%, 64%, and 70% of AF patients converted after a mean time of 62, 55, and 26 minutes, respectively, whereas no placebo-treated patients converted. SR was maintained for 24 hours in 21 of 22 patients with drug-associated conversion. AZD7009 treatment was associated with QT-interval prolongation; the increase in QT corrected according to Fridericia typically ranged from 40 to 80 ms at targeted pseudo–steady-state plasma concentrations ≥0.75 μmol/L, but a number of outliers with QT corrected according to Fridericia >550 ms were seen in the higher concentration groups, particularly after conversion to SR and prolonged infusion. None of the patients exhibited torsades de pointes according to predefined criteria; however, one patient exhibited a nonsustained, polymorphic ventricular tachycardia of eight beats with torsades de pointes–like features after AZD7009 infusion (asymptomatic and discovered only upon retrospective Holter tape analysis). Clinical adverse events (primarily dizziness, bradycardia, hypotension, and nausea) were significantly more common in the highest target concentration AZD7009 group vs placebo (P <.001). Conclusion AZD7009 exhibited dose-dependent effects in converting AF to SR in AF patients and appeared to be associated with a low risk of proarrhythmia despite continued administration during a period of heightened vulnerability.
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36.
  • Eckard, Nathalie, et al. (author)
  • Cost-Effectiveness of Catheter Ablation Treatment for Patients with Symptomatic Atrial Fibrillation
  • 2009
  • In: Journal of Atrial Fibrillation. - : Cardiofront, LLC. - 1941-6911. ; 1:8, s. 461-470
  • Journal article (peer-reviewed)abstract
    • Background:  Atrial Fibrillation is the most common cardiac arrhythmia.  It increases the risk of thromboembolic events and many atrial fibrillation patients suffer quality of life impairment due to disturbed heart rhythm.  Pulmonary vein isolation using radiofrequency catheter ablation treatment is aimed at maintaining sinus rhythm ultimately improving quality of life.  Randomized clinical trial have shown that catheter ablation is more effective than antiarrhythmic drugs for the treatment of atrial fibrillation, but its impact on quality of life and cost-effectiveness has not been widely studied.  Aims:  To assess the cost-effectiveness of radiofrequency ablation (RFA) vs. antiarrhythmic drug (AAD) treatment, among symptomatic atrial fibrillation patients not previously responding to AAD.  Methods:  A decision-analytic Markov model was developed to assess costs and health outcomes in terms of quality adjusted life years (QALYs) of RFA and AAD over a lifetime time horizon.  We conducted a literature search and used data from several sources as input variables of the model.  One-year rates of atrial fibrillation with RFA and AAD, respectively, were available from published randomized clinical trials.  Other data sources were published papers and register data.  Results:  The RFA treatment strategy was associated with reduced costs and an incremental gain in QALYs compared to the AAD treatment strategy.  The results were sensitive to whether long-term quality of life improvement is maintained for the RFA treatment strategy and the risk of stroke in the different atrial fibrillation health states.  Conclusion:  This study shows that the short-term improvement in atrial fibrillation associated with RFA is likely to lead to long-term quality of life improvement and lower costs indicating that RFA is cost-effective compared to AAD. 
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37.
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38.
  • Englund, Anders, et al. (author)
  • Kateterburen ablation - bättre än läkemedel.
  • 2015
  • In: Läkartidningen. - : Läkartidningen Förlag. - 0023-7205 .- 1652-7518. ; 112
  • Journal article (other academic/artistic)abstract
    • Randomiserade studier har visat att ablation av förmaksflimmer har bättre effekt än antiarytmisk medicinering. Enligt europeiska och ameri­kanska riktlinjer kan alla typer av förmaksflimmer komma ifråga för ablation. Hos patienter med paroxysmalt förmaksflimmer är lyckandefrekvensen ca 70–80 procent, medan den är något lägre vid persisterande och långvarigt flimmer. Risken för allvarliga komplikationer är låg, <1,0 procent.
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39.
  • Hansen, Peter Steen, et al. (author)
  • Safety of novel oral anticoagulants in catheter ablation of atrial fibrillation
  • 2016
  • In: Danish Medical Journal. - Copenhagen, Denmark : Danish Medical Association. - 2245-1919. ; 63:2, s. A5186-
  • Journal article (peer-reviewed)abstract
    • INTRODUCTION: Limited data are available regarding safety of catheter ablation of atrial fibrillation (AF) in patients using novel oral anticoagulants (NOAC) before and after pulmonary vein isolation. We aimed to assess the safety of a simple anticoagulation protocol in consecutive patients -presenting for catheter ablation of AF. METHODS: From November 2011 to December 2014, we prospectively included 234 patients referred for catheter ablation of AF who had already received NOAC treatment. NOAC was continued for a minimum of three months after ablation. We assessed procedure-related bleeding or thromboembolic complications, bleeding or thromboembolic complications during a three-month follow-up period and patient-reported adherence to NOAC therapy. The study has not received financial support from external resources. The study was registered with ClinTrials.gov as NCT02569255. RESULTS: A total of 171 patients were treated with dabigatran (94% 150 mg twice daily), 38 with rivaroxaban (100% 20 mg daily) and 25 with apixaban (100% 5 mg twice daily). NOACs were interrupted for 24 hours before and re-administered two hours after the ablation procedure, without bridging with low molecular weight heparin (LMWH). No periprocedural thromboembolic complications and no bleeding complications were registered except for one pericardial effusion which was percutaneously drained without further complications. No thromboembolic or bleeding complications during follow-up were registered. All patients continued the same NOAC during follow-up as before ablation. CONCLUSIONS: Anticoagulation with NOAC with a short period of periprocedural interruption without bridging with LMWH seems safe and well-tolerated.
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40.
  • Jons, Christian, et al. (author)
  • The Medical Antiarrhythmic Treatment or Radiofrequency Ablation in Paroxysmal Atrial Fibrillation (MANTRA-PAF) trial : clinical rationale, study design, and implementation
  • 2009
  • In: Europace. - : Oxford University Press (OUP). - 1099-5129 .- 1532-2092. ; 11:7, s. 917-923
  • Journal article (peer-reviewed)abstract
    • AIMS: No large randomized multicentre trial has evaluated the efficacy of radiofrequency ablation (RFA) vs. anti-arrhythmic drug (AAD) therapy as a first-line treatment of paroxysmal atrial fibrillation (AF). METHODS AND RESULTS: The Medical ANtiarrhythmic Treatment or Radiofrequency Ablation (MANTRA-PAF) trial is a randomized, controlled, parallel group, multicentre study designed to test whether catheter-based RFA is superior to optimized AAD therapy in suppressing relapse within 24 months of symptomatic and/or asymptomatic AF in patients with paroxysmal AF without prior AAD therapy. The primary endpoint is cumulative AF burden on repeated 7 days Holter monitoring. Secondary endpoints are: thromboembolic events, hospitalization due to arrhythmia, pro-arrhythmic events, procedure/treatment-related side effects, health economics, quality of life, and change in left ventricular function. Ten centres in Scandinavia and Germany are participating in the study. Enrolment was started in 2005 and as of November 2008, 260 patients have been enrolled into the study. It is expected that enrolment will end by March 2009, when 300 patients have been included. CONCLUSION: The MANTRA-PAF trial will determine whether catheter-based RFA is superior to optimized AAD therapy as a first-line treatment in suppressing long-term relapse of symptomatic and/or asymptomatic AF.
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41.
  •  
42.
  • Jönsson, Anders, et al. (author)
  • Microwave Ablation in Mitral Valve Surgery for Atrial Fibrillation (MAMA)
  • 2012
  • In: Journal of Atrial Fibrillation. - : Cardiofront. - 1941-6911. ; 5:2, s. 13-22
  • Journal article (peer-reviewed)abstract
    • Objective: Microwave ablation in conjunction with open heart surgery is effective in restoring sinus rhythm (SR) in patients with atrial fibrillation (AF). In patients assigned for isolated mitral valve surgery no prospective randomized trial has reported its efficacy.Methods: 70 patients with longlasting AF where included from 5 different centres. They were randomly assigned to mitral valve surgery and atrial microwave ablation or mitral valve surgery alone.Results: Out of 70 randomized, 66 and 64 patients were available for evaluation at 6 and 12 months. At 12 months SR was restored and preserved in 71.0 % in the ablation group vs 36.4 % in the control group (P=0.006), corresponding figures at 6 months was 62.5 % vs 26.5 % (P=0.003). The 30-day mortality rate was 1.4 %, with one death in the ablation group vs zero deaths in the control group. At 12 months the mortality rate was 7,1 % (Ablation n=3 vs Control n=2). No significant differences existed between the groups with regard to the overall rate of serious adverse events (SAE) during the perioperative period or at the end of the study. 16 % of patients randomized to ablation were on antiarrhytmic drugs compared to 6 % in the control group after 1 year (p=0.22).Conclusion: Microwave ablation of left and right atrium in conjunction with mitral valve surgery is safe and effectively restores sinus rhythm in patients with longlasting AF as compared to mitral valve surgery alone.
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43.
  • Liuba, Ioan, et al. (author)
  • Activation mapping of focal atrial tachycardia : the impact of the method for estimating activation time
  • 2009
  • In: Journal of Interventional Cardiac Electrophysiology. - : Springer. - 1383-875X .- 1572-8595. ; 26:3, s. 169-180
  • Journal article (peer-reviewed)abstract
    • PurposeDifferent methods can be used to estimate activation time during the mapping of focal atrial tachycardia. The present study aimed to compare activation maps generated by three widely used methods of determining activation time.MethodsFourteen patients (mean age 48 ± 17 years) with focal atrial tachycardia were investigated. Mapping was performed with the CARTO system. All patients underwent successful ablation. Local activation time was successively defined as the peak amplitude (Bi-peak), the steepest downslope (Bi-dslope), and the onset (Bi-on) of the bipolar electrograms.ResultsThe three methods of activation time determination were highly correlated with one another but generated foci with different locations. The distances between the foci generated by the different methods were 4.36 ± 4.91 mm (Bi-peak–Bi-dslope), 7.21 ± 5.11 mm (Bi-peak–Bi-on), and 7.21 ± 5.87 mm (Bi-dslope–Bi-on) (p = 0.26). Also, the three methods generated foci with different diameters: 3.13 ± 2.17 mm for Bi-peak, 2.81 ± 0.78 for Bi-dslope, and 2.54 ± 0.14 mm for Bi-on (p = 0.60). However, the foci tended to cluster within relatively wide regions of low-amplitude fractionated electrograms. The surface of these regions was 3.81 ± 2.34 cm2 (Bi-peak), 3.38 ± 2.12 cm2 (Bi-dslope), and 4.76 ± 3.01 cm2 (Bi-on) (p = 0.34).ConclusionThe three methods of activation time determination, although highly correlated with one another, may generate foci of different sizes and in different locations. However, the foci tend to cluster within relatively large areas of low-amplitude fractionated electrograms. These findings suggest a sizeable atrial region with particular electrophysiological proprieties and raise the possibility of an anatomical substrate of the tachycardia. During mapping, this region can be roughly delineated by all three methods of activation time estimation. However, details concerning the activation pattern within the region and the location of the focus vary among the methods.
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44.
  • Liuba, Ioan, et al. (author)
  • Corrigendum for: Focal atrial tachycardia : increased electrogram fractionation in the vicinity of the earliest activation site. In Europace (ISSN 1099-5129), vol 10, issue 11, pg 1357
  • 2008
  • In: Europace. - : Oxford University Press (OUP). - 1099-5129 .- 1532-2092. ; 10:11, s. 1357-1357
  • Journal article (other academic/artistic)abstract
    • P values of P < 0.0001 should have been given in the abstractfor the increase within the region activated during the first15 ms of both the incidence of bipolar electrograms with multiplenegative deflections and of the incidence of unipolar electrogramswith multiple negative deflections.In the section ‘Characteristics of electrograms in theregion surrounding the earliest activation site and in the remainingatrium’ the P value for bipolar voltage should be P <0.0001, not P < 0001. In the same section the P value forthe decrease of unipolar and bipolar peak-to-peak voltage shouldbe P < 0.0001, not P < 0001.
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45.
  • Liuba, Ioan, et al. (author)
  • Electroanatomic Mapping of Focal Atrial Tachycardia : Reproducibility ofActivation Time Measurement and Focus Localization
  • 2010
  • Journal article (other academic/artistic)abstract
    • Background: Different algorithms of estimating local activation time (LAT) can be usedduring the mapping of focal atrial tachycardia (FAT). Objective: The impact of these algorithms on the reproducibility of LAT measurementand the location of the focus. Methods: Fifteen patients (48 ± 17 yrs) with FAT were studied. Three independentobservers reviewed 1438 bipolar electrograms and successively assigned the LAT on thepeak amplitude (Bi-peak), the steepest downslope (Bi-dslope), and the onset (Bi-on) ofthe electrograms. The reproducibility of LAT measurement was estimated. Results: The mean interobserver absolute differences in LAT for the three algorithmswere 1.47 ± 2.75 ms (Bi-peak) vs. 2.15 ± 3.89 ms (Bi-dslope) vs. 2.87 ± 3.47 (Bi-on) (p <0.0001). The corresponding intraobserver differences were 2.29 ± 3.74 ms (Bi-peak) vs2.47 ± 4.17 ms (Bi-dslope) vs 3.16 ± 4.49 ms (Bi-on) (p < 0.0001). The interobserverdifferences in the location of the focus were 3.57 ± 3.81 mm (Bi-peak) vs 5.47 ± 4.98mm (Bi-dslope) vs 6.57 ± 6.94 mm (Bi-on) (p = 0.03), with differences of up to 13 mm(Bi-peak), 16 mm (Bi-dslope), and 25 mm (Bi-on). However, regardless of the method ofLAT determination, the foci computed by the three observers clustered within regions oflow-amplitude fractionated electrograms. Conclusions: Significant observer variability exists among the three algorithms, whichtend to compute different LAT and foci with different locations. However, the foci aresituated in regions of low voltage fractionated electrograms.
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46.
  • Liuba, Ioan, et al. (author)
  • Focal atrial tachycardia: increased electrogram fractionation in the vicinity of the earliest activation site.
  • 2008
  • In: Europace. - : Oxford University Press (OUP). - 1099-5129 .- 1532-2092. ; 10:10, s. 1195-1204
  • Journal article (peer-reviewed)abstract
    • Aims: Fractionated electrograms are often noted during mapping of focal atrial tachycardia (FAT). This finding suggests poor cell-to-cell coupling, which is thought to be an important prerequisite in the process of ectopic impulse initiation and propagation. The purpose of the present study was to assess the electrogram fractionation in the vicinity of the earliest activation site and in the remaining atrium in these patients. Methods and results: Thirteen patients with FAT (age 48 ± 17 years) who underwent catheter ablation were investigated. Mapping was performed with the CARTO system. Electrogram fractionation was assessed on the basis of the number of negative deflections, both in the region surrounding the earliest activation site and in the remaining atrium. Unipolar and bipolar peak-to-peak voltage and bipolar electrogram duration were also studied. All patients underwent successful radiofrequency ablation. A higher degree of electrogram fractionation existed in the region surrounding the earliest activation site and activated within the first 15 ms when compared with the remaining atrium (incidence of bipolar electrograms with multiple negative deflections: 88 vs. 79%, P < 0.0001; incidence of unipolar electrograms with multiple negative deflections: 56 vs. 43%, P = 0.0001). The peak-to-peak voltage in the region activated within the first 15 ms was less than that in the remaining atrium (bipolar voltage: 1.33 ± 0.99 vs. 1.61 ± 1.11 mV, P < 0.001; unipolar voltage: 1.75 ± 0.92 vs. 1.95 ± 1.11 mV, P = 0.0188). There were no significant differences in bipolar electrogram duration. Within the region activated during the first 15 ms, from the periphery to the earliest activation site, there was a gradual increase in electrogram fractionation (incidence of bipolar electrograms with multiple negative deflections gradually increasing from 82 to 100% and incidence of unipolar electrograms with multiple negative deflections increasing from 56 to 90%), as well as a gradual decrease in peak-to-peak voltage (bipolar voltage gradually decreasing from 1.47 ± 1.06 to 0.89 ± 0.54 mV, P < 0.0001; unipolar voltage gradually decreasing from 1.89 ± 0.94 to 1.30 ± 0.63 mV, P < 0.0001). Irregular, closely spaced isochrones were also noted in the region activated during the first 15 ms. The area of this region was 4.88 ± 3.59 cm2. Conclusion: Increased electrogram fractionation exists within a relatively wide region around the tachycardia origin when compared with the remaining atrium. Moreover, this region is electrically heterogeneous, as suggested by the fact that the degree of electrogram fractionation increases gradually whereas the electrogram voltage decreases gradually towards the earliest activation site. These findings suggest that a non-discrete atrial region with gradually changing electrophysiological properties may underlie the substrate of FAT.
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47.
  • Liuba, Ioan, et al. (author)
  • Gender-related differences in patients with atrioventricular nodal reentry tachycardia
  • 2006
  • In: American Journal of Cardiology. - : Elsevier BV. - 0002-9149 .- 1879-1913. ; 97:3, s. 384-388
  • Journal article (peer-reviewed)abstract
    • The present study sought to assess the extent of gender differences in electrophysiologic parameters in patients with atrioventricular nodal reentrant tachycardia (AVNRT). The study population consisted of 203 patients (women/men ratio 2:1) who underwent slow pathway ablation. Patients with associated heart disease experienced the first episode of tachycardia at a significantly older age than patients with lone AVNRT (women 50 ± 18 vs 29 ± 15 years, p <0.0001, men 45 ± 20 vs 31 ± 17 years, p = 0.01). Sinus cycle length (797 ± 142 vs 870 ± 161 ms, p = 0.0001), HV interval (41 ± 7 vs 45 ± 8 ms, p = 0.0001), atrioventricular (AV) block cycle length (348 ± 53 vs 371 ± 75 ms, p = 0.01), slow pathway effective refractory period (ERP) (258 ± 46 vs 287 ± 62 ms, p = 0.006), and tachycardia cycle length (354 ± 58 vs 383 ± 60 ms, p = 0.001) were shorter in women. No gender differences were noted in fast pathway ERP and ventriculoatrial (VA) block cycle length. In women, an AV block cycle length <350 ms along with a VA block cycle length <400 ms predicted tachycardia induction without the need for autonomic intervention, with a positive predictive value of 93% (sensitivity 71%, specificity 82%). No such cut-off values could be found in men. The acute success rate (100% vs 98%) and the recurrence rate (3% vs 6%) were similar for the 2 genders. In conclusion, in patients with lone AVNRT, the onset of symptoms occurred at a younger age than in patients with concomitant heart disease. Women had shorter slow pathway refractory periods, AV block cycle lengths, and tachycardia cycle lengths. No gender differences were noted in the fast pathway ERP. Therefore, women have a wider "tachycardia window" (i.e., the difference between the fast and slow pathway refractory periods), a finding that may explain their greater incidence of AVNRT. © 2006 Elsevier Inc. All rights reserved.
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48.
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49.
  • Liuba, Ioan, et al. (author)
  • Source of inflammatory markers in patients with atrial fibrillation
  • 2008
  • In: Europace. - : Oxford University Press. - 1099-5129 .- 1532-2092. ; 10, s. 848-853
  • Journal article (peer-reviewed)abstract
    • Aims Elevated levels of C-reactive protein and other inflammatory markers have been reported in some patients with atrial fibrillation (AF). Whether this finding is related to AF per se or to other conditions remains unclear. In addition, the source of inflammatory markers is unknown. Therefore, in the present study, we sought to assess the extent and the source of inflammation in patients with AF and no other concomitant heart or inflammatory conditions. Methods and results The study group consisted of 29 patients referred for radiofrequency catheter ablation: 10 patients with paroxysmal AF, 8 patients with permanent AF, and 10 control patients with Wolf-Parkinson-White (WPW) syndrome and no evidence of AF (mean age 54±11 vs. 57±13 vs. 43±16). No patient had structural heart diseases or inflammatory conditions. High-sensitive C-reactive protein, interleukin-6 (IL-6), and interleukin-8 (IL-8) were assessed in blood samples from the femoral vein, right atrium, coronary sinus, and the left and right upper pulmonary veins. All samples were collected before ablation. Compared with controls and patients with paroxysmal AF, patients with permanent AF had higher plasma levels of IL-8 in the samples from the femoral vein, right atrium, and coronary sinus, but not in the samples from the pulmonary veins (median values in the femoral vein: 2.58 vs. 2.97 vs. 4.66 pg/mL, P = 0.003; right atrium: 2.30 vs. 3.06 vs. 3.93 pg/mL, P = 0.013; coronary sinus: 2.85 vs. 3.15 vs. 4.07, P = 0.016). A high-degree correlation existed between the IL-8 levels in these samples (correlation coefficient between 0.929 and 0.976, P< 0.05). No differences in the C-reactive protein and IL-6 levels were noted between the three groups of patients. Conclusion The normal levels of C-reactive protein and IL-6, alongwith the elevated levels of IL-8 in patients with permanent AF but not in those with paroxysmal AF, suggest a link between a low-grade inflammatory reaction and long-lasting AF. The elevated IL-8 levels in the peripheral blood, right atrium, and coronary sinus but not in the pulmonary veins suggest a possible source of inflammation in the systemic circulation.
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50.
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