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1.	Holmgren, Christina M, et al. (author) Changes in Medication Preceding Out-of-hospital Cardiac Arrest Where Resuscitation Was Attempted 2014 In: Journal of Cardiovascular Pharmacology. - : Lippincott Williams & Wilkins. - 0160-2446 .- 1533-4023. ; 63:6, s. 497-503 Journal article (peer-reviewed)abstract Objective: To describe recent changes in medication preceding out-of-hospital cardiac arrest (OHCA) where resuscitation was attempted. Methods: OHCA victims were identified by the Swedish Cardiac Arrest Register and linked by means of their unique 10-digit personal identification numbers to the Prescribed Drug Register. We identified new claimed prescriptions during a 6-month period before the OHCA compared with those claimed in the period 12 to 18 months before. The 7-digit Anatomical Therapeutical Chemical codes of individual drugs were used. The study period was November 2007-January 2011. Results: OHCA victims with drugs were (1) older than those who did not claim any drugs in any period (70 +/- 16 years vs. 54 +/- 22 years, P < 0.001), (2) more often women (34% vs. 20%, P < 0.001), and (3) had more often a presumed cardiac etiology (67% vs. 54%, P < 0.001). The OHCA victims were less likely to have ventricular tachycardia/ventricular fibrillation as the first recorded ;rhythm (26% vs. 33%, P < 0.001) or to survive 1 month (9% vs. 17%, P < 0.0001). New prescriptions were claimed by 5122 (71%) of 7243 OHCA victims. The most frequently claimed new drugs were paracetamol (acetaminophen) 10.3%, furosemide 7.8%, and omeprazole 7.6%. Of drugs known or supposed to cause QT prolongation, ciprofloxacin was the most frequent (3.4%) altogether; 16% had a new claimed prescription of a drug included in the "qtdrugs.org" lists. Conclusions: Most OHCA victims had new drugs prescribed within 6 months before the event but most often intended for diseases other than cardiac. No claims can be made as to the causality.
2.	Abrahamsson, C., et al. (author) Assessment of Ventricular Repolarization Variability with the DeltaT50 Method Improves Identification of Patients with Congenital Long QT Syndromes 2013 In: Annals of Noninvasive Electrocardiology. - : Wiley. - 1082-720X. ; 18:3, s. 240-250 Journal article (peer-reviewed)abstract Background We analyzed ventricular repolarization variability in genotyped long QT syndrome (LQTS)
3.	Abrahamsson, Christina, et al. (author) DeltaT50 - a new method to assess temporal ventricular repolarization variability 2011 In: Journal of Electrocardiology. - : Elsevier BV. - 1532-8430 .- 0022-0736. ; 44:4 Journal article (peer-reviewed)abstract Background Increased beat-to-beat variability in cardiac repolarization time is a tentative risk marker of drug-induced torsades de pointes. We developed a new, automatic method based on the temporal variability of the T-wave down slope to assess this variability. Method and Results Leads V1 to V6 of resting electrocardiograms were recorded in 42 healthy subjects (18-68 years, 22 men). The temporal variability at 50% of the T-wave down slope, deltaT50 (1.5 ± 0.41 milliseconds; range, 0.86-2.66 milliseconds), was measured with an accuracy of 1 millisecond on at least 9 pairs of electrocardiogram complexes with a signal-to-noise ratio more than 10 and changes in the R-R interval less than 150 milliseconds. The correlation between repeated measurements of deltaT50 was high. DeltaT50 was measured without corrections for age, sex, heart rate, T-wave amplitude, signal-to-noise ratio, R-R variability, and QTcF because none of these factors explained more than 4% of the within-subject deltaT50 variability. Conclusion The beat-to-beat repolarization variability was measured with high fidelity with the deltaT50 method and was a robust measure in healthy volunteers.
4.	Andersson, Tommy, 1970-, et al. (author) All-cause mortality in 272 186 patients hospitalized with incident atrial fibrillation 1995-2008 : a Swedish nationwide long-term case-control study 2013 In: European Heart Journal. - : Oxford University Press (OUP). - 0195-668X .- 1522-9645. ; 34:14, s. 1061-1067 Journal article (peer-reviewed)abstract Aims To evaluate long-term all-cause risk of mortality in women and men hospitalized for the first time with atrial fibrillation (AF) compared with matched controls. Methods and results A total of 272 186 patients (44% women) <= 85 years at the time of hospitalization with incidental AF 1995-2008 and 544 344 matched controls free of in-hospital diagnosis of AF were identified. Patients were followed via record linkage of the Swedish National Patient Registry and the Cause of Death Registry. Using Cox regression models, the long-term relative all-cause mortality risk, adjusted for concomitant diseases, in women vs. controls was 2.15, 1.72, and 1.44 (P < 0.001) in the age categories <= 65, 65-74, and 75-85 years, respectively. The corresponding figures for men were 1.76, 1.36, and 1.24 (P < 0.001). Among concomitant diseases, neoplasm, chronic renal failure, and chronic obstructive pulmonary disease contributed most to the increased all-cause mortality vs. controls. In patients with AF as the primary diagnosis, the relative risk of mortality was 1.63, 1.46, and 1.28 (P < 0.001) in women and 1.45, 1.17, and 1.10 (P < 0.001) in men. Conclusion Atrial fibrillation was an independent risk factor of all-cause mortality in patients with incident AF. The concomitant diseases that contributed most were found outside the thromboembolic risk scores. The highest relative risk of mortality was seen in women and in the youngest patients compared with controls, and the differences between genders in each age category were statistically significant.
5.	Andersson, Tommy, 1970-, et al. (author) Gender-related differences in risk of cardiovascular morbidity and all-cause mortality in patients hospitalized with incident atrial fibrillation without concomitant diseases: A nationwide cohort study of 9519 patients 2014 In: International Journal of Cardiology. - : Elsevier BV. - 0167-5273 .- 1874-1754. ; 177:1, s. 91-99 Journal article (peer-reviewed)abstract Background: Previous studies of patients with "lone" and "idiopathic" atrial fibrillation (AF) have provided conflicting evidence concerning the development, management and prognosis of this condition. Methods: In this nation-wide, retrospective, cohort study, we studied patients diagnosed with incidental AF recorded in national Swedish registries between 1995 and 2008. Controls were matched for age, sex and calendar year of the diagnosis of AF in patients. All subjects were free of any in-hospital diagnosis from 1987 and until patients were diagnosed with AF and also free of any diagnosis within one year from the time of inclusion. Follow-up continued until 2009. We identified 9519 patients (31% women) and 12,468 matched controls. Results: Relative risks (RR) versus controls for stroke or transient ischemic attack (TIA) in women were 19.6, 4.4, 3.4 and 2.5 in the age categories <55, 55-64, 65-74 and 75-85, years respectively. Corresponding figures for men were 3.4, 2.5, 1.7 and 1.9. RR for heart failure were 6.6, 6.6, 6.3 and 3.8 in women and 7.8, 4.6, 4.9 and 2.9 in men. All RR were statistically significant with p < 0.01. RR for myocardial infarction and all-cause mortality were statistically significantly increased only in the two oldest age categories in women and 65-74 years in men. Conclusions: Patients with AF and no co-morbidities at inclusion had at least a doubled risk of stroke or TIA and a tripled risk of heart failure, through all age categories, as compared to controls. Women were at higher RR of stroke or TIA than men. (C) 2014 The Authors. Published by Elsevier Ireland Ltd. This is an open access article under the CC BY-NC-SA license (http://creativecommons.org/licenses/by-nc-sa/3.0/).
6.	Andersson, Tommy, 1970-, et al. (author) Patients with atrial fibrillation and outcomes of cerebral infarction in those with treatment of warfarin versus no warfarin with references to CHA(2)DS(2)-VASc score, age and sex - A Swedish nationwide observational study with 48 433 patients 2017 In: PLoS ONE. - : Public Library of Science (PLoS). - 1932-6203. ; 12:5 Journal article (peer-reviewed)abstract Aims There is controversy in the guidelines as to whether patients with atrial fibrillation and a low risk of stroke should be treated with anticoagulation, especially those with a CHA(2)DS(2)-VASc score of 1 point. In a retrospective, nationwide cohort study, we used the Swedish National Patient Registry, the National Prescribed Drugs Registry, the Swedish Registry of Education and the Population and Housing Census Registry. 48 433 patients were identified between 1 January 2006 and 31 December 2008 with incident atrial fibrillation who were divided in age categories, sex and a CHA(2)DS(2)-VASc score of 0, 1, 2 and >= 3 and they were included in a time-varying analysis of warfarin treatment versus no treatment. The primary end-point was cerebral infarction and stroke, and patients were followed until 31 December 2009. Patients with 1 point from the CHA(2)DS(2)-VASc score showed the following adjusted hazard ratios (HR) with a 95% confidence interval: men 65-74 years 0.46 (0.25-0.83), men < 65 years 1.11 (0.56-2.23) and women < 65 years 2.13 (0.94-4.82), where HR < 1 indicates protection with warfarin. In patients < 65 years and 2 points, HR in men was 0.35 (0.18-0.69) and in women 1.84 (0.86-3.94) while, in women with at least 3 points, HR was 0.31 (0.16-0.59). In patients 65-74 years and 2 points, HR in men was 0.37 (0.23-0.59) and in women 0.39 ( 0.21-0.73). Categories including age >= 65 years or >= 3 points showed a statistically significant protection from warfarin. Our results support that treatment with anticoagulation may be considered in all patients with an incident atrial fibrillation diagnosis and an age of 65 years and older, i.e. also when the CHA(2)DS(2)-VASc score is 1.
7.	Andersson, Tommy, 1970-, et al. (author) Patients without comorbidities at the time of diagnosis of atrial fibrillation : causes of death during long-term follow-up compared to matched controls 2017 In: Clinical Cardiology. - : John Wiley & Sons. - 0160-9289 .- 1932-8737. ; 40:11, s. 1076-1082 Journal article (peer-reviewed)abstract BACKGROUND: Little is known about the long-term, cause-specific mortality risk in patients without comorbidities at the time of diagnosis of atrial fibrillation (AF).METHODS: From a nation-wide registry of patients hospitalized with incident AF between 1995 and 2008 we identified 9 519 patients with a first diagnosed AF and no comorbidities at the time of AF diagnosis. They were matched with 12 468 controls. The follow-up continued until December 2008. Causes of death were classified according to the ICD-10 codes.RESULTS: During follow-up, 11.1% of patients with AF and 8.3% of controls died. Cardiovascular diseases were the most common causes of death and the only diagnoses which showed significantly higher relative risk in patients with AF than controls (HR 2.0, 95% CI 1.8-2.3), and the relative risk was significantly higher in women than in men. Stroke was a more common cause among patients with AF, 13.1% versus 9.7% (HR 2.7, 95% CI 1.8-4.0), while cerebral hemorrhage was more common among controls, 4.7% versus 10.2% (HR 0.9, 95% CI 0.6-1.5). The time from AF diagnosis to death was 6.0 ± 3.1 years.CONCLUSIONS: In patients with incident AF and no known comorbidities at the time of AF diagnosis, only cardiovascular diseases were more often causes of death as compared to controls. Women carried a significantly higher relative risk than men.
8.	Aunes-Jansson, Maria, et al. (author) Decrease of the atrial fibrillatory rate, increased organization of the atrial rhythm and termination of atrial fibrillation by AZD7009 2013 In: Journal of Electrocardiology. - : Elsevier BV. - 1532-8430 .- 0022-0736. ; 46:1, s. 29-35 Journal article (peer-reviewed)abstract Background: The atrial fibrillatory rate (APR), on AZD7009 as compared to placebo, was investigated as a potential biomarker for electrophysiological effect in early antiarrhythmic drug development. Methods: Patients with permanent AF received infusions of AZD7009 and placebo in an exploratory two-way, single-blind, randomized cross-over study. The ECG was continuously recorded, and following QRST cancellation the APR, its standard deviation (SD), the exponential decay and the atrial electrogram amplitude were determined as 3-min averages. Results: The mean APR rapidly decreased by 43% from baseline (394 +/- 38 to 225 +/- 61 fibrillations/min, p = 0.0003) on AZD7009, but not on placebo. The SD of the AFR and the exponential decay decreased in parallel. In 2 of 8 patients, termination of AF occurred after the APR had decreased by 58% and 53%, respectively. Conclusions: The APR may potentially serve as a biomarker of electrophysiological effects in early evaluation of rhythm control agents. (C) 2013 Elsevier Inc. All rights reserved.
9.	Aunes-Jansson, Maria, et al. (author) Rapid slowing of the atrial fibrillatory rate after administration of AZD7009 predicts conversion of atrial fibrillation. 2014 In: Journal of electrocardiology. - : Elsevier BV. - 1532-8430 .- 0022-0736. ; 47:3, s. 316-323 Journal article (peer-reviewed)abstract Effects on the atrial fibrillatory rate (AFR) were studied during infusion with the combined potassium and sodium channel blocker AZD7009.
10.	Aunes-Jansson, Maria, et al. (author) T wave inversions following ablation of 125 posteroseptal accessory pathways 2006 In: Int J Cardiol. - : Elsevier BV. - 0167-5273. ; 106:1, s. 75-81 Journal article (peer-reviewed)abstract BACKGROUND: Cardiac memory, electrophysiological remodeling induced by periods of altered ventricular activation, has been observed after resumption of normal activation following ablation of overt accessory pathways. We studied the occurrence and temporal characteristics of cardiac memory (inferior T wave inversions) after ablation of overt posteroseptal accessory pathways. METHODS: T wave changes were assessed in the frontal plane (leads II, aVF, and III) up to one year after the ablation in 125 consecutive patients. T wave polarity immediately after ablation was compared with the pre ablation delta wave polarity and the dominant QRS force in each lead. The number of inferior leads (0-3) with post ablation T wave changes (estimate of degree of cardiac memory) was analyzed in relation to estimates of the degree of preexcitation (accessory pathway refractoriness and QRS duration) prior to ablation. RESULTS: Electrocardiogram (ECG) signs of cardiac memory were present in 123 (98%) of the patients within one day after ablation. The post ablation T wave vector had the same direction as the vector of the pre-excited QRS complex (and delta wave) creating inferior T wave inversions. There was no correlation between the degree of preexcitation pre ablation and the extent of cardiac memory post ablation. A majority (about 90%) of ECGs recorded 3-6 months after the procedure, showed complete or almost complete normalization. CONCLUSIONS: T wave inversions were present in the vast majority of patients, persisted in some patients beyond 3 months, and might be misinterpreted as inferior wall ischemia.
11.	Bentzen, B. H., et al. (author) Mechanisms of Action of the KCa2-Negative Modulator AP30663, a Novel Compound in Development for Treatment of Atrial Fibrillation in Man 2020 In: Frontiers in Pharmacology. - : Frontiers Media SA. - 1663-9812. ; 11 Journal article (peer-reviewed)abstract Aims Small conductance Ca2+-activated K+ channels (SK channels, K(Ca)2) are a new target for treatment of atrial fibrillation (AF). AP30663 is a small molecule inhibitor of K(Ca)2 channels that is currently in clinical development for treatment of AF. The aim of this study is to present the electrophysiological profile and mechanism of action of AP30663 and its efficacy in prolonging atrial refractoriness in rodents, and by bioinformatic analysis investigate if genetic variants in KCNN2 or KCNN3 influence the expression level of these in human heart tissue. Methods and Results Whole-cell and inside-out patch-clamp recordings of heterologously expressed K(Ca)2 channels revealed that AP30663 inhibits K(Ca)2 channels with minor effects on other relevant cardiac ion channels. AP30663 modulates the K(Ca)2.3 channel by right-shifting the Ca2+-activation curve. In isolated guinea pig hearts AP30663 significantly prolonged the atrial effective refractory period (AERP) with minor effects on the QT-interval corrected for heart rate. Similarly, in anaesthetized rats 5 and 10 mg/kg of AP30663 changed the AERP to 130.7 +/- 5.4% and 189.9 +/- 18.6 of baseline values. The expression quantitative trait loci analyses revealed that the genome wide association studies for AF SNP rs13376333 in KCNN3 is associated with increased mRNA expression of KCNN3 in human atrial appendage tissue. Conclusions AP30663 is a novel negative allosteric modulator of K(Ca)2 channels that concentration-dependently prolonged rodent atrial refractoriness with minor effects on the QT-interval. Moreover, AF associated SNPs in KCNN3 influence KCNN3 mRNA expression in human atrial tissue. These properties support continued development of AP30663 for treatment of AF in man.
12.	Bergfeldt, Lennart, 1950, et al. (author) Analysis of initial rhythm, witnessed status and delay to treatment among survivors of out-of-hospital cardiac arrest in Sweden. 2010 In: Heart. - : BMJ Group. - 1355-6037 .- 1468-201X. ; 96:22, s. 1826-1830 Journal article (peer-reviewed)abstract Abstract Background The characteristics of patients who survive out-of-hospital cardiac arrest (OHCA) are incompletely known. The characteristics of survivors of OHCA during a period of 16 years in Sweden are described. Methods All the patients included in the Swedish Cardiac Arrest Registry between 1992 and 2007 in whom cardiopulmonary resuscitation was attempted and who were alive after 1 month were included in the survey. Results In all, 2432 survivors were registered. Information on initial rhythm at their first ECG recording was missing in 11%. Of the remaining 2165 survivors, 80% had a shockable rhythm and 20% had a non-shockable rhythm. Only a minority with a shockable rhythm among the bystander-witnessed cases were defibrillated within 5 min after cardiac arrest. This proportion did not change during the entry period. Among survivors found in a non-shockable rhythm, the majority were bystander-witnessed cases and a few had a delay from cardiac arrest to ambulance arrival of <5 min. Of all survivors, more women (27%) than men (18%) were found in a non-shockable rhythm (p<0.0001). During the 16 years in which the register was used for this study, the proportion of survivors found in a shockable rhythm did not change significantly. The cerebral performance categories score indicated better cerebral function among patients found in a shockable rhythm than in those found in a non-shockable rhythm. Conclusion Among survivors of OHCA, a substantial proportion was found in a non-shockable rhythm and this occurred more frequently in women than in men. The proportion of survivors found in a shockable rhythm has not changed markedly over time. Survivors found in a shockable rhythm had a better cerebral performance than survivors found in a non-shockable rhythm. The proportion of survivors who were bystander-witnessed and found in a shockable rhythm and defibrillated early is still remarkably low.
13.	Björkenheim, Anna, 1980-, et al. (author) Assessment of Atrial Fibrillation–Specific Symptoms Before and 2 Years After Atrial Fibrillation Ablation : Do Patients and Physicians Differ in Their Perception of Symptom Relief? 2017 In: JACC. - : Elsevier. - 2405-500X .- 2405-5018. ; 3:10, s. 1168-1176 Journal article (peer-reviewed)abstract Objectives: The aim of this study was to evaluate patient-reported and physician-assessed atrial fibrillation (AF)–related symptoms after AF ablation.Background: Success of AF ablation is usually defined as freedom from AF, although symptom relief is often patients’ desire.Methods: Symptom relief was assessed as perceived by patients using the short, validated, AF-specific symptom questionnaire AF6 and as classified by physicians using the European Heart Rhythm Association (EHRA) classification at baseline and 6, 12, and 24 months after AF ablation. Recurrence of arrhythmia was documented by continuous electrocardiographic monitoring.Results: In total, 54 patients completed the 24-month follow-up. All 6 items on the AF6, AF6 sum score, and EHRA class improved significantly over time. The greatest improvement was seen during the first 6 months after ablation, but AF6 scores showed continued improvement up to 12 months, in contrast to EHRA class. There was a low correlation between AF6 score and EHRA class, but the predictive ability was low. Both AF6 scores and EHRA class were significantly correlated with AF burden at all times after ablation. A change of >9 points in AF6 sum score corresponded to a meaningful reduction in symptom severity.Conclusion: Patient-reported and physician-assessed outcomes were both useful in assessing symptom relief after AF ablation, although patient-reported outcomes were more sensitive tools. There was also a discrepancy between patient-reported and physician-assessed outcomes after ablation. Freedom from AF and a low AF burden most often resulted in a reduction of symptoms, but symptom relief also occurred despite little effect on the arrhythmia.
14.	Björkenheim, Anna, 1980-, et al. (author) Is AF burden <0.5% a clinically meaningful criterion of success after AF ablation? 2017 Conference paper (peer-reviewed)
15.	Björkenheim, Anna, 1980-, et al. (author) Patient-reported outcomes in relation to continuously monitored rhythm before and during 2 years after atrial fibrillation ablation using a disease-specific and a generic instrument 2018 In: Journal of the American Heart Association. - : Wiley-Blackwell Publishing Inc.. - 2047-9980. ; 7:5 Journal article (peer-reviewed)abstract Background--Atrial fibrillation (AF) ablation improves patient-reported outcomes, irrespective of mode of intermittent rhythm monitoring. We evaluated the use of an AF-specific and a generic patient-reported outcomes instrument during continuous rhythm monitoring 2 years after AF ablation. Methods and Results--Fifty-four patients completed the generic 36-Item Short-Form Health Survey and the AF-specific AF6 questionnaires before and 6, 12, and 24 months after AF ablation. All patients underwent continuous ECG monitoring via an implantable loop recorder. The generic patient-reported outcomes scores were compared with those of a Swedish age- and sexmatched population. After ablation, both summary scores reached normative levels at 24 months, while role-physical and vitality remained lower than norms. Responders to ablation (AF burden < 0.5%) reached the norms in all individual 36-Item Short-Form Health Survey domains, while nonresponders (AF burden > 0.5%) reached norms only in social functioning and mental component summary. All AF6 items and the sum score showed moderate to large improvement in both responders and nonresponders, although responders showed significantly greater improvement in all items except item 1 from before to 24 months after ablation. Higher AF burden was independently associated with poorer physical component summary and AF6 sum score. Conclusions--The AF-specific AF6 questionnaire was more sensitive to changes related to AF burden than the generic 36-Item Short-Form Health Survey. Patients improved as documented by both instruments, but a higher AF burden after ablation was associated with poorer AF-specific patient-reported outcomes and poorer generic physical but not mental health. Our results support the use of an AF-specific instrument, alone or in combination with a generic instrument, to assess the effect of ablation. © 2018 The Authors.
16.	Björkenheim, Anna, 1980-, et al. (author) Patient-reported Outcomes In Relation To Continuously Monitored Rhythm Before And During Two Years After Atrial Fibrillation Ablation Using A Disease-specific And A Generic Instrument 2018 Conference paper (peer-reviewed)abstract Background: Patients with AF have a lower health-related quality of life (HRQoL) than the general population.Objective: To assess the effect of AF ablation on AF-specific and generic patient-reported outcomes (PRO), compare it to a Swedish age- and sex-matched population and evaluate any association with the AF burden.Methods: Patients scheduled for AF ablation completed the generic SF-36 and the AF-specific PRO questionnaires before and six, 12 and 24 months after AF ablation. All patients underwent continuous ECG monitoring via an implantable loop recorder.Results: 54 patients completed the follow-up. After ablation, the generic SF-36 improved and both summary scores reached normative levels at 24 months, while physical functioning, role-physical and vitality remained lower than norms. Responders with an AF burden ≤0.5% at each visit after ablation reached the norms in all domains, while non-responders reached norms in only social functioning and MCS. All AF6 items and the sum score showed moderate to large improvement in both responders and non-responders. Higher AF burden was independently associated with poorer PCS and AF6 sum score. The AF sum score correlated with all SF-36 domains, but all AF6 items did not correlate with the SF-36 summary scores.Conclusion: The AF-specific AF6 questionnaire was more sensitive to changes in PRO related to AF burden than was the generic SF-36. Higher AF burden after ablation was associated with poorer AF-specific PRO and poorer generic physical but not mental health. Focusing on AF-specific symptoms and their impact on quality of life as an outcome after AF ablation is reasonable, as improving PROs is the main goal of AF ablation.
17.	Björkenheim, Anna, 1980-, et al. (author) Patient-reported outcomes in relation to continuously monitored rhythm before and during two years after atrial fibrillation ablation using a disease-specific and a generic instrument 2018 Conference paper (peer-reviewed)abstract Background: Atrial fibrillation (AF) ablation improves patient-reported outcomes (PROs), irrespective of mode of intermittent rhythm monitoring.Purpose: To evaluate the use of an AF-specific and a generic PRO instrument during continuous rhythm monitoring two years after AF ablation.Methods: Fifty-four patients completed the generic SF-36 and the AF-specific AF6 questionnaires before and six, 12 and 24 months after AF ablation. All patients underwent continuous ECG monitoring via an implantable loop recorder. The generic PRO scores were compared to those of a Swedish age- and sex-matched population.Results: After ablation both summary scores reached normative levels at 24 months, while physical functioning, role-physical and vitality remained lower than norms. Responders to ablation (AF burden <0.5%) reached the norms in all individual SF-36 domains, while non-responders (AF burden >0.5%) reached norms only in social functioning. All AF6 items and the sum score showed moderate to large improvement in both responders and non-responders, although responders had significantly lower scores 24 months after ablation. Higher AF burden was independently associated with poorer PCS and AF6 sum score.Conclusions: The AF-specific AF6 questionnaire was more sensitive to changes related to AF burden than the generic SF-36. Patients improved as documented by both instruments, but a higher AF burden after ablation was associated with poorer AF-specific PROs and poorer generic physical but not mental health. Our results support the use of an AF-specific instrument, alone or in combination with a generic instrument, to assess the effect of ablation.
18.	Björkenheim, Anna, 1980-, et al. (author) Predictors of hospitalization for heart failure and of all-cause mortality after atrioventricular nodal ablation and right ventricular pacing for atrial fibrillation 2014 In: Europace. - : Oxford University Press. - 1099-5129 .- 1532-2092. ; 16:12, s. 1772-1778 Journal article (peer-reviewed)abstract Aims: Atrioventricular junction ablation (AVJA) is a highly effective treatment in patients with therapy refractory atrial fibrillation (AF) but renders the patient pacemaker dependent. We aimed to analyse the long-term incidence of hospitalization for heart failure (HF) and all-cause mortality in patients who underwent AVJA because of AF and to determine predictors for HF and mortality.Methods and results: We retrospectively enrolled 162 consecutive patients, mean age 67 +/- 9 years, 48% women, who underwent AVJA because of symptomatic AF refractory to pharmacological treatment (n = 117) or unsuccessful repeated pulmonary vein isolation (n = 45). Hospitalization for HF occurred in 32 (20%) patients and 35 (22%) patients died, representing a cumulative incidence for hospitalization for HF and mortality over the first 2 years after AVJA of 9.1 and 5.2%, respectively. Hospitalization for HF occurred to the same extent in patients who failed pharmacological treatment as in patients with repeated pulmonary vein isolation (PVI), although the mortality was slightly higher in the former group. QRS prolongation >= 120 ms and left atrial diameter were independent predictors of hospitalization for HF, while hypertension and previous HF were independent predictors of death.Conclusion: The long-term hospitalization rate for HF and all-cause mortality was low, which implies that long-term ventricular pacing was not harmful in this patient population, including patients with unsuccessful repeated PVI.
19.	Björkenheim, Anna, 1980-, et al. (author) Rhythm Control and its Relation to Symptoms During the First Two Years After Radiofrequency Ablation for Atrial Fibrillation 2016 In: Pacing and Clinical Electrophysiology. - Hoboken, USA : Wiley-Blackwell Publishing Inc.. - 0147-8389 .- 1540-8159. ; 39:9, s. 914-925 Journal article (peer-reviewed)abstract Objective: To evaluate rhythm control up to two years after AF ablation and its relation to reported symptoms.Background: The implantable loop recorder (ILR) continuously records the ECG, has an automatic AF detection algorithm and a possibility for patients to activate an ECG recording during symptoms.Methods: Fifty-seven patients (mean age 57±9 years, 60% male, 88% paroxysmal AF) underwent AF ablation following ILR implantation. Device data were downloaded at the ablation and three, six, 12, 18 and 24 months after ablation.Results: Fifty-four patients completed the two-year follow-up. Thirteen (24%) patients had no AF episodes detected by ILR during follow-up. Ten of 41 patients (24%) with AF recurrence were only detected by ILR and AF recurrences were detected earlier by ILR (P<0.001). The median AF burden in patients with AF recurrence was 5.7% (IQR 0.4-14.4) and was even lower in patients with AF only detected by ILR (P = 0.001). Forty-eight % of the patients indicated symptoms via the patient activator but 33% of those recordings were not due to AF. Early AF recurrence (within 3 months) was highly associated with later AF recurrence (P<0.001). AF burden >0.5% and longest >6h before the ablation were independent predictors of AF recurrence during intermittent but not continuous monitoring.Conclusions: After AF ablation, the AF burden was low throughout the 24 months follow-up. Nevertheless, symptoms were commonly indicated but one third of patient activated recordings did not show AF. Continuous monitoring was superior to intermittent follow-up in detecting AF episodes and assessing the AF burden.Clinical trial registration: URL: http://clinicaltrials.gov. Unique Identifier: NCT00697359.
20.	Blomström-Lundqvist, Carina, et al. (author) A randomized double-blind study of epicardial left atrial cryoablation for permanent atrial fibrillation in patients undergoing mitral valve surgery: the SWEDish Multicentre Atrial Fibrillation study (SWEDMAF). 2007 In: European heart journal. - : Oxford University Press (OUP). - 0195-668X .- 1522-9645. ; 28:23, s. 2902-8 Journal article (peer-reviewed)abstract AIMS: The efficacy of epicardial left atrial (LA) cryoablation in eliminating atrial fibrillation (AF) in patients undergoing mitral valve surgery (MVS) is unknown. We hypothesized that MVS combined with LA cryoablation is superior to MVS alone. METHODS AND RESULTS: Sixty-nine patients with permanent AF, included at four centres, underwent MVS with or without epicardial LA cryoablation. The primary endpoint was regained sinus rhythm. Risk factors for failed AF cryoablation were elucidated. Sixty-five out of 69 patients reached the primary endpoint. At 6 and 12 months follow-up, 73.3% of patients who underwent cryoablation had regained sinus rhythm at both follow-ups, compared with 45.7 and 42.9% of patients, respectively, who underwent MVS alone (group differences, at 6 months P = 0.024, after 12 months P = 0.013). The in-hospital complication rate was 11.4% in the MVS group and 26.5% in the cryoablation group (P = 0.110). Risk factors for failed elimination of AF by cryoablation were duration of permanent AF (P = 0.012) and presence of coronary artery disease (P = 0.047), according to multiple logistic regression analysis. CONCLUSION: This first prospective randomized study showed that combining MVS with epicardial LA cryoablation is significantly better in eliminating pre-operative permanent AF than MVS alone.
21.	Bolse, Kärstin, et al. (author) Life situation related to the ICD implantation : self-reported uncertainty and satisfaction in Swedish and US samples 2002 In: European Journal of Cardiovascular Nursing. - Amsterdam : Elsevier. - 1474-5151 .- 1873-1953. ; 1:4, s. 243-251 Journal article (peer-reviewed)abstract The aim of the study was to describe changes in the life situation related to the ICD implantation of Swedish and US samples with regard to uncertainty and satisfaction. The life situation was measured by reference to the uncertainty caused by the condition and satisfaction with the life situation. Inferential statistics were used to analyse changes within and between the Swedish and US samples. Uncertainty showed a statistically significant difference between the Swedish and US samples before as well as after the ICD implantation. A higher level of uncertainty was indicated for the US sample prior to the ICD implantation and for the Swedish sample following the implantation. In the Swedish sample, satisfaction with life showed a statistically significant difference within the socio-economic domain, indicating a higher degree of satisfaction 3 months after implantation. Satisfaction within the domains of health and functioning, socio-economics and psychological-spiritual showed a statistically significant difference between the Swedish and US samples both before and after ICD implantation, indicating a higher degree of satisfaction in the US sample. The previous study shows that the ICD-patient's life situation is changed after the implantation and that it is necessary to provide the patient with information and education based on their own preconditions. The fact that US sample was investigated at a later stage after ICD implantation than the Swedish sample may have influenced the results of the study.
22.	Boriani, Giuseppe, et al. (author) Plateau waveform shape allows a much higher patient shock energy tolerance in AF patients. 2007 In: Journal of cardiovascular electrophysiology. - : Wiley. - 1540-8167 .- 1045-3873. ; 18:7, s. 728-34 Journal article (other academic/artistic)abstract OBJECTIVES: To evaluate the possible pain reduction of the plateau waveform in atrial fibrillation (AF) patients. BACKGROUND: Previous studies have indicated that reduced amplitude waveforms would be less painful than a conventional (65/65% tilt) biphasic waveform. Computer modeling suggested that a moderately long (10-12 msec) plateau (flat topped) shock waveform would deliver equivalent effectiveness with the lowest possible peak amplitude. METHODS: We enrolled 27 patients at two sites with persistent AF with a total of 220 shocks delivered during internal atrial cardioversion using an interleaved crossover design. Patient response was scored in three ways: (1) a verbally reported discomfort score, (2) visual analog scale (VAS), and (3) a blinded observer reporting a contraction score. RESULTS: All scores were significantly reduced (P < 0.0001) by the plateau waveform with impressive statistics: Verbal discomfort (3.51 +/- 0.13 to 2.89 +/- 0.12), VAS (7.00 +/- 0.56 to 5.91 +/- 0.36), and contraction scores (1.94 +/- 0.12 to 1.62 +/- 0.12). The average pain threshold shift (TS) for the Verbal score was 2.34, while that for the VAS score was 2.30. (This means that the patient typically could tolerate 2.34 times as much energy with the plateau waveform for the same level of verbally reported discomfort.) The contraction TS was less at 1.57. Response scores were also corrected for the shock sequence number to control for the sensitization effect from multiple shocks. This increased the TS for the Verbal score to 3.58, but the shock number was not significant for the VAS. A pulmonary artery electrode return was associated with lower pain compared with a coronary sinus position. CONCLUSION: A plateau shaped biphasic waveform resulted in significantly increased shock energy pain tolerances. Controlling for session sensitization, patients tolerated over three times as much energy for the same verbally reported discomfort score.
23.	Camm, A J, et al. (author) Conventional and dedicated atrial overdrive pacing for the prevention of paroxysmal atrial fibrillation: the AFTherapy study. 2007 In: Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology. - : Oxford University Press (OUP). - 1532-2092. ; 9:12, s. 1110-8 Journal article (peer-reviewed)abstract AIMS: This investigation was conducted to determine the effectiveness of several conventional overdrive pacing modalities (single rate and rate responsive pacing at various lower rates) and of four dedicated preventive pacing algorithms in the suppression of paroxysmal atrial fibrillation (AF). METHOD AND RESULTS: In this multi-centre, randomized trial, 372 patients with drug-refractory paroxysmal AF were enrolled. Patients received a dual-chamber pacing device capable of delivering conventional pacing therapy as well as dedicated AF prevention pacing therapies and to record detailed AF-related diagnostics. The primary endpoint was AF burden, whereas secondary endpoints were time to first AF episode and averaged sinus rhythm duration. During a conventional pacing phase, patients were randomized to single rate or rate-responsive pacing with lower rates of either 70 or 85 min(-1) or to a control group with single rate pacing at 40 min(-1). In the subsequent preventive pacing phase, patients underwent pacing at a lower rate of 70 min(-1) with or without concomitant application of four preventive pacing algorithms. A substantial amount of data was excluded from the analysis because of atrial-sensing artefacts, identified in the device-captured diagnostics. In the conventional pacing phase, no significant differences were found between various lower rates and the control group receiving single rate pacing at 40 min(-1) or between single rate and rate-responsive pacing. Patients receiving preventive pacing with all four therapies enabled had a similar AF burden compared with patients treated with conventional pacing at 70 min(-1) (P = 0.47). CONCLUSIONS: The results do not demonstrate a significant effect of conventional atrial overdrive pacing or preventive pacing therapies. However, the observations provided important information for further consideration with respect to the design and conduct of future studies on the effect of atrial pacing therapies for the reduction of AF.
24.	Carlson, Tobias, 1976, et al. (author) Interference of transcutaneous electrical nerve stimulation with permanent ventricular stimulation: a new clinical problem? 2009 In: Europace. - 1532-2092. ; 11:3, s. 364-9 Journal article (peer-reviewed)abstract AIMS: To assess the compatibility of thoracic TENS and permanent PM treatment and to identify any signs of interference of TENS with the PM function. METHODS AND RESULTS: Twenty-seven patients treated with PM were tested. Transcutaneous electric nerve stimulation electrodes were placed above each mamilla, and the stimulation intensity was increased to the maximum level tolerated for 30 s or until electrocardiogram revealed signs of interference. Transcutaneous electric nerve stimulation of 2 and 80 Hz was tested with the PM ventricular sensing level set to the clinically chosen level as well as to maximal sensitivity. Interference was detected in 22 of 27 patients (81%). Low-frequency (2 Hz) stimulation was more associated with PM interference (52% at normal vs. 81% at maximal ventricular sensitivity) than high-frequency (80 Hz) stimulation (33% at normal vs. 63% at maximal ventricular sensitivity); although the differences were not statistically significant. CONCLUSION: Transcutaneous electric nerve stimulation frequently induces inhibition of the PM function already at the clinically set ventricular sensitivity. Therefore, individual testing is warranted before TENS treatment is considered in patients with a PM. A test protocol for TENS and PM interaction is proposed.
25.	Citerini, Charlotta, et al. (author) Inhibition of KCa2 and Kv11.1 Channels in Pigs With Left Ventricular Dysfunction. 2020 In: Frontiers in pharmacology. - : Frontiers Media SA. - 1663-9812. ; 11 Journal article (peer-reviewed)abstract Inhibition of KCa2 channels, conducting IKCa, can convert atrial fibrillation (AF) to sinus rhythm and protect against its induction. IKCa inhibition has been shown to possess functional atrial selectivity with minor effects on ventricles. Under pathophysiological conditions with ventricular remodeling, however, inhibiting IKCa can exhibit both proarrhythmic and antiarrhythmic ventricular effects. The aim of this study was to evaluate the effects of the IKCa inhibitor AP14145, when given before or after the IKr blocker dofetilide, on cardiac function and ventricular proarrhythmia markers in pigs with or without left ventricular dysfunction (LVD).Landrace pigs were randomized into an AF group (n = 6) and two control groups: SHAM1 (n = 8) and SHAM2 (n = 4). AF pigs were atrially tachypaced (A-TP) for 43 ± 4 days until sustained AF and LVD developed. A-TP and SHAM1 pigs received 20 mg/kg AP14145 followed by 100 µg/kg dofetilide whereas SHAM2 pigs received the same drugs in the opposite order. Proarrhythmic markers such as short-term variability of QT (STVQT) and RR (STVRR) intervals, and the number of premature ventricular complexes (PVCs) were measured at baseline and after administration of drugs. The influence on cardiac function was assessed by measuring cardiac output, stroke volume, and relevant echocardiographic parameters.IKCa inhibition by AP14145 did not increase STVQT or STVRR in any of the pigs. IKr inhibition by dofetilide markedly increased STVQT in the A-TP pigs, but not in SHAM operated pigs. Upon infusion of AP14145 the number of PVCs decreased or remained unchanged both when AP14145 was infused after baseline and after dofetilide. Conversely, the number of PVCs increased or remained unchanged upon dofetilide infusion. Neither AP14145 nor dofetilide affected relevant echocardiographic parameters, cardiac output, or stroke volume in any of the groups.IKCa inhibition with AP14145 was not proarrhythmic in healthy pigs, or in the presence of LVD resulting from A-TP. In pigs already challenged with 100 µg/kg dofetilide there were no signs of proarrhythmia when 20 mg/kg AP14145 were infused. KCa2 channel inhibition did not affect cardiac function, implying that KCa2 inhibitors can be administered safely also in the presence of LV dysfunction.
26.	Citerni, Carlotta, et al. (author) Characterization of Atrial and Ventricular Structural Remodeling in a Porcine Model of Atrial Fibrillation Induced by Atrial Tachypacing. 2020 In: Frontiers in veterinary science. - : Frontiers Media SA. - 2297-1769. ; 7:April Journal article (peer-reviewed)abstract Background: Atrial fibrillation (AF) is characterized by electrical and structural remodeling. Irregular and/or fast atrio-ventricular (AV) conduction during AF can result in AV dyssynchrony, tachymyopathy, pressure and volume overload with subsequent dilatation, valve regurgitation, and ventricular dysfunction with progression to heart failure. Objective: To gain further insight into the myocardial pathophysiological changes induced by right atrial tachypacing (A-TP) in a large animal model. Methods: A total of 28 Landrace pigs were randomized as 14 into AF-induced A-TP group and 14 pigs to control group. AF pigs were tachypaced for 43 ± 4 days until in sustained AF. Functional remodeling was investigated by echocardiography (after cardioversion to sinus rhythm). Structural remodeling was quantified by histological preparations with picrosirius red and immunohistochemical stainings. Results: A-TP resulted in decreased left ventricular ejection fraction (LVEF) accompanied by increased end-diastolic and end-systolic left atrium (LA) volume and area. In addition, A-TP was associated with mitral valve (MV) regurgitation, diastolic dysfunction and increased atrial and ventricular fibrotic extracellular matrix (ECM). Conclusions: A-TP induced AF with concomitant LV systolic and diastolic dysfunction, increased LA volume and area, and atrial and ventricular fibrosis.
27.	Claesson, Jan-Eric, et al. (author) Less syncope and milder symptoms in patients treated with pacing for induced cardioinhibitory carotid sinus syndrome: a randomized study 2007 In: EUROPACE. - : Oxford University Press (OUP). - 1099-5129 .- 1532-2092. ; 9:10, s. 932-936 Journal article (peer-reviewed)
28.	Coyne, Karin S, et al. (author) Development and Validation of the AFImpact: An Atrial Fibrillation-Specific Measure of Patient-Reported Health-Related Quality of Life. 2017 In: Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research. - : Elsevier BV. - 1524-4733. ; 20:10, s. 1355-1361 Journal article (peer-reviewed)abstract Improvement in health-related quality of life is a key therapeutic goal of disease management in atrial fibrillation (AF).To describe the development of the AFImpact, an AF-specific health-related quality-of-life patient-reported outcome measure.Development and validation of the AFImpact comprised a qualitative stage, consisting of a literature review and concept elicitation interviews (91 patients with AF), item generation, and cognitive debriefing (30 patients with AF), and a quantitative stage, consisting of evaluation of the instrument's psychometric properties (313 patients with AF). Preliminary responsiveness to change was assessed in 118 patients undergoing cardioversion.On the basis of the literature review and concept elicitation interviews, 75 items were generated. Factor analyses guided a reduction to 18 items. Three domains were confirmed: vitality (7 items), emotional distress (8 items), and sleep (3 items). The 18-item AFImpact demonstrated high item convergent and discriminant validity. Cronbach α coefficients showed high internal consistency reliability. Test-retest reliability of individual items in stable patients (n = 33) was satisfactory, with intraclass correlation coefficients ranging from 0.61 to 0.86. All three AFImpact domain scores differentiated patients who reported different levels of overall health, thereby supporting known-groups validity. Scores for each item improved after cardioversion, with effect sizes ranging from -0.19 to -0.65.Psychometric evaluations support the reliability and validity of the AFImpact as a patient-reported outcome instrument to measure the impact of AF, with preliminary results in patients undergoing cardioversion supporting responsiveness to change.
29.	Diness, J. G., et al. (author) Inhibition of K(Ca)2 Channels Decreased the Risk of Ventricular Arrhythmia in the Guinea Pig Heart During Induced Hypokalemia 2020 In: Frontiers in Pharmacology. - : Frontiers Media SA. - 1663-9812. ; 11 Journal article (peer-reviewed)abstract Background Hypokalemia reduces the cardiac repolarization reserve. This prolongs the QT-interval and increases the risk of ventricular arrhythmia; a risk that is exacerbated by administration of classical class 3 anti-arrhythmic agents. Small conductance Ca2+-activated K+-channels (K(Ca)2) are a promising new atrial selective target for treatment of atrial fibrillation. Under physiological conditions K(Ca)2 plays a minor role in ventricular repolarization. However, this might change under hypokalemia because of concomitant increases in ventriculay -60r intracellur Ca2+. Purpose To study the effects of pharmacological K(Ca)2 channel inhibition by the compounds AP14145, ICA, or AP30663 under hypokalemic conditions as compared to dofetilide and hypokalemia alone time-matched controls (TMC). Methods The current at +10 mV was compared in HEK293 cells stably expressing K(Ca)2.3 perfused first with normo- and then hypokalemic solutions (4 mM K+ and 2.5 mM K+, respectively). Guinea pig hearts were isolated and perfused with normokalemic (4 mM K+) Krebs-Henseleit solution, followed by perfusion with drug or vehicle control. The perfusion was then changed to hypokalemic solution (2.5 mM K+) in presence of drug. 30 animals were randomly assigned to 5 groups: ICA, AP14145, AP30663, dofetilide, or TMC. QT-interval, the interval from the peak to the end of the T wave (Tp-Te), ventricular effective refractory period (VERP), arrhythmia score, and ventricular fibrillation (VF) incidence were recorded. Results Hypokalemia slightly increased K(Ca)2.3 current compared to normokalemia. Application of K(Ca)2 channel inhibitors and dofetilide prolonged the QT interval corrected for heart rate. Dofetilide, but none of the K(Ca)2 channel inhibitors increased Tp-Te during hypokalemia. During hypokalemia 4/6 hearts in the TMC group developed VF (two spontaneously, two by S1S2 stimulation) whereas 5/6 hearts developed VF in the dofetilide group (two spontaneously, three by S1S2 stimulation). In comparison, 0/6, 1/6, and 1/6 hearts developed VF when treated with the K(Ca)2 channel inhibitors AP30663, ICA, or AP14145, respectively. Conclusion Hypokalemia was associated with an increased incidence of VF, an effect that also seen in the presence of dofetilide. In comparison, the structurally and functionally different K(Ca)2 channel inhibitors, ICA, AP14145, and AP30663 protected the heart from hypokalemia induced VF. These results support that K(Ca)2 inhibition may be associated with a better safety and tolerability profile than dofetilide.
30.	Diness, J. G., et al. (author) The KCa2 Channel Inhibitor AP30663 Selectively Increases Atrial Refractoriness, Converts Vernakalant-Resistant Atrial Fibrillation and Prevents Its Reinduction in Conscious Pigs 2020 In: Frontiers in Pharmacology. - : Frontiers Media SA. - 1663-9812. ; 11 Journal article (peer-reviewed)abstract Aims: To describe the effects of the KCa2 channel inhibitor AP30663 in pigs regarding tolerability, cardiac electrophysiology, pharmacokinetics, atrial functional selectivity, effectiveness in cardioversion of tachy-pacing induced vernakalant-resistant atrial fibrillation (AF), and prevention of reinduction of AF. Methods and Results: Six healthy pigs with implanted pacemakers and equipped with a Holter monitor were used to compare the effects of increasing doses (0, 5, 10, 15, 20, and 25 mg/kg) of AP30663 on the right atrial effective refractory period (AERP) and on various ECG parameters, including the QT interval. Ten pigs with implanted neurostimulators were long-term atrially tachypaced (A-TP) until sustained vernakalant-resistant AF was present. 20 mg/kg AP30663 was tested to discover if it could successfully convert vernakalant-resistant AF to sinus rhythm (SR) and protect against reinduction of AF. Seven anesthetized pigs were used for pharmacokinetic experiments. Two pigs received an infusion of 20 mg/kg AP30663 over 60 min while five pigs received 5 mg/kg AP30663 over 30 min. Blood samples were collected before, during, and after infusion on AP30663. AP30663 was well-tolerated and prominently increased the AERP in pigs with little effect on ventricular repolarization. Furthermore, it converted A-TP induced AF that had become unresponsive to vernakalant, and it prevented reinduction of AF in pigs. Both a >30 ms increase of the AERP and conversion of AF occurred in different pigs at a free plasma concentration level of around 1.0–1.4 µM of AP30663, which was achieved at a dose level of 5 mg/kg. Conclusion: AP30663 has shown properties in animals that would be of clinical interest in man. © Copyright © 2020 Diness, Kirchhoff, Speerschneider, Abildgaard, Edvardsson, Sørensen, Grunnet and Bentzen.
31.	Dota, Corina-Dana, et al. (author) PC-Based ECG waveform recognition-validation of novel software against a reference ECG database 2009 In: Ann Noninvasive Electrocardiol. - 1542-474X. ; 14 Suppl 1 Journal article (peer-reviewed)abstract BACKGROUND: PC-based ECG measurements must cope with normal as well as pathological ECGs in a reliable manner. EClysis, a software for ECG measurements was tested against reference values from the Common Standards for Quantitative Electrocardiography (CSE) database. METHODS: Digital ECGs (12 leads, 500 Hz) were recorded by the CSE project. Data Set 3 contains reference values for 125 ECGs (33 normal and 92 pathological). Median values of measurements by 11 computer programs and by five cardiologists, respectively, refer to the earliest P and QRS onsets and to the latest P, QRS, and T offsets in any lead of a selected (index) beat. EClysis automatically measured all ECGs, without user interference. RESULTS: The PQRST points were correctly detected but in two ECGs with AV block II-III. The software was not designed to detect atrial activity in atrial fibrillation (n = 9) and flutter (n = 1). In one case of atrial fibrillation, atrial activity interfered with positioning of QRS and T offsets. Regression coefficients between EClysis and CSE (software-generated and human) were above 0.95 (P < 0.0001). The confidence intervals were 95% for the slope and the intercept of the regression lines. CONCLUSIONS: The PC-based detection and analysis of PQRST points showed a high level of agreement with the CSE database reference values.
32.	E, Sandgren, et al. (author) Role of baseline 12‑lead ECG in predicting syncope caused by arrhythmia in patients investigated using an implantable loop recorder. 2019 In: International journal of cardiology. Heart & vasculature. - : Elsevier BV. - 2352-9067. ; 24 Journal article (peer-reviewed)abstract To evaluate the role of baseline 12‑lead ECG in predicting the syncope mechanism during continuous monitoring using an implantable loop recorder (ILR).Consecutive patients with syncope implanted with an ILR were enrolled. Baseline 12‑lead ECG were related to ECG diagnosis derived from ILR tracings recorded at the time of syncope recurrence.In total 300 patients with a mean age of 66±16years were included, 49% (146/300) received an ILR-guided diagnosis during follow-up. Patients with abnormal baseline ECG more frequently received an ILR-guided diagnosis compared to those with normal baseline ECG 59% vs. 44%, p=0.018. For a diagnosis of arrhythmic syncope, the corresponding frequencies were 45% vs. 26%, p=0.001.Patients with bifascicular block significantly more common received an ILR-guided diagnosis 76% (25/33) compared to those with normal baseline ECG 44% (90/205), p≪0.001. In this subgroup, 96% (24/25) were diagnosed with arrhythmic syncope, 23 of which were due to bradyarrhythmia. Bifascicular block occurred almost exclusively among those ≥60years (31/33). After logistic regression the adjusted OR for arrhythmic syncope was significant for bifascicular block 5.5 (95%CI 2.3-13.2), p≪0.001. PPV for bifascicular block in predicting arrhythmic syncope was 73% and NPV 73%.A baseline 12‑lead ECG with bifascicular block was a strong predictor for syncope during follow-up, most often due to bradyarrhythmia caused by intermittent complete heart block. No other ECG findings were associated with the ILR outcome. We find it reasonable to consider permanent pacing instead of an ILR for patients with bifascicular block and unexplained syncope.
33.	Edvardsson, Berit, et al. (author) The medical and social prognosis of Sick Building Syndrome : a follow-up study focusing on female patients 2005 In: Indoor air 2005. - Beijing : Tsinghua university press. ; , s. 3706-3710 Conference paper (peer-reviewed)abstract A follow-up questionnaire focusing medical and social status, actions taken and personality traits was sent to 239 patients with Sick Building Syndrome (SBS) registered at the University Hospital in Umea, Sweden. The response rate was 79 percent. As females constituted 92 percent of the respondents all statistical analyses were restricted to women. Almost half of the respondents had been exposed to environments with visible water damages. Fatigue, irritated eyes and facial erythema were the most common symptoms. Nearly half of the patients claimed that the symptoms were more or less unchanged after 7 years or more. Twenty-five percent of the patients were on the sick-list and twenty percent drew disability pension due to SBS-symptoms at follow-up. Symptoms were often aggravated in different situations in everyday life. No important deviations concerning personality factors were found. The results support that early and comprehensive measures for rehabilitation are essential for these patients.
34.	Edvardsson, Jenny (author) Guide till att läsa och skriva poesi : Arbeta med poesi i undervisningen 2020 Book (other academic/artistic)abstract Hur kan man arbeta med poesi i undervisningen? Det handlar den här guiden om. Tips och idéer varvas med konkreta uppgifter. Här finns exempel på hur elever kan skriva, läsa och analysera poesi.
35.	Edvardsson, Nils, 1942, et al. (author) Costs of unstructured investigation of unexplained syncope: insights from a micro-costing analysis of the observational PICTURE registry. 2015 In: Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology. - : Oxford University Press (OUP). - 1532-2092. ; 17:7, s. 1141-1148 Journal article (peer-reviewed)abstract The observational PICTURE (Place of Reveal In the Care pathway and Treatment of patients with Unexplained Recurrent Syncope) registry enrolled 570 patients with unexplained syncope, documented their care pathway and the various tests they underwent before the insertion of an implantable loop recorder (ILR). The aims were to describe the extent and cost of diagnostic tests performed before the implant.
36.	Edvardsson, Nils, 1942, et al. (author) Inverse Correlation between the Atrial Fibrillatory Rate and the Ventricular Repolarization Time: Observations at Baseline and after an Intravenous Infusion of a Combined Potassium and Sodium Current Blocker. 2016 In: Annals of noninvasive electrocardiology : the official journal of the International Society for Holter and Noninvasive Electrocardiology, Inc. - : Wiley. - 1542-474X. ; 21:3, s. 236-245 Journal article (peer-reviewed)abstract The atrial fibrillatory rate (AFR) and the ventricular rate and repolarization (QTcF) were studied at baseline and under the influence of the combined potassium and sodium current blocker AZD7009.
37.	Edvardsson, Nils, 1942, et al. (author) Unexplained Syncope: Implications of Age and Gender on Patient Characteristics and Evaluation, the Diagnostic Yield of an Implantable Loop Recorder, and the Subsequent Treatment. 2014 In: Clinical cardiology. - : Wiley. - 1932-8737 .- 0160-9289. ; 37:10, s. 618-625 Journal article (peer-reviewed)abstract Background Syncope is a common clinical problem with a variety of underlying mechanisms, some of which occur more frequently in 1 of the sexes or at a certain age. Hypothesis There may be clinically significant age- and gender-related differences in patients with unexplained syncope. Methods Five hundred seventy patients (54% women) with unexplained syncope received an implantable loop recorder (ILR) and were followed until diagnosis or for at least 1 year. Results Women were older and more prone to severe trauma during syncope (40.8% vs 29.9%, P = 0.007), and hospitalization was more common at ≥65 years (P = 0.003) without gender difference. Muscle spasms or grand mal seizures were more common in men and at <65 years old. Carotid sinus pressure, exercise testing, coronary angiography and magnetic resonance imaging/computed tomography scans were more commonly performed in men, whereas no test was more common in women. Tilt testing, exercise test, electroencephalography, and neurological or psychiatric evaluation were more common at ≥65 years. There were no age- or gender-related differences in the diagnostic yield of the ILR, whereas patients ≥65 years old more often received specific treatment based on ILR data. Conclusions Gender and/or age had relevance for the clinical evaluation, rate of recurrence, and subsequent specific treatment but not for the diagnostic yield of the ILR.
38.	Edvardsson, Nils, 1942, et al. (author) Use of an implantable loop recorder to increase the diagnostic yield in unexplained syncope: results from the PICTURE registry. 2011 In: Europace. - : Oxford University Press (OUP). - 1532-2092 .- 1099-5129. ; 13:2, s. 262-269 Journal article (peer-reviewed)abstract Aims To collect information on the use of the Reveal implantable loop recorder (ILR) in the patient care pathway and to investigate its effectiveness in the diagnosis of unexplained recurrent syncope in everyday clinical practice. Methods and results Prospective, multicentre, observational study conducted in 2006-2009 in 10 European countries and Israel. Eligible patients had recurrent unexplained syncope or pre-syncope. Subjects received a Reveal Plus, DX or XT. Follow up was until the first recurrence of a syncopal event leading to a diagnosis or for ≥1 year. In the course of the study, patients were evaluated by an average of three different specialists for management of their syncope and underwent a median of 13 tests (range 9-20). Significant physical trauma had been experienced in association with a syncopal episode by 36% of patients. Average follow-up time after ILR implant was 10 ± 6 months. Follow-up visit data were available for 570 subjects. The percentages of patients with recurrence of syncope were 19, 26, and 36% after 3, 6, and 12 months, respectively. Of 218 events within the study, ILR-guided diagnosis was obtained in 170 cases (78%), of which 128 (75%) were cardiac. Conclusion A large number of diagnostic tests were undertaken in patients with unexplained syncope without providing conclusive data. In contrast, the ILR revealed or contributed to establishing the mechanism of syncope in the vast majority of patients. The findings support the recommendation in current guidelines that an ILR should be implanted early rather than late in the evaluation of unexplained syncope.
39.	Egstrup, Kenneth, et al. (author) QT Response after a Test Dose and during Maintenance Therapy with AZD1305 in Patients with Atrial Fibrillation: A Double-Blind, Randomized, Placebo-Controlled Trial. 2011 In: American journal of cardiovascular drugs : drugs, devices, and other interventions. - : Springer Science and Business Media LLC. - 1179-187X. ; 11:3, s. 199-208 Journal article (peer-reviewed)abstract Background and Objective: AZD1305 is an investigational antiarrhythmic agent that prolongs refractoriness through combined potassium and sodium channel inhibition. This study aimed to explore the utility of a test dose in predicting QT interval corrected according to Fridericia's formula (QTcF) during subsequent maintenance treatment with AZD1305. Methods: This was a randomized, double-blind, parallel-group, placebo-controlled trial carried out at multiple hospital cardiac facilities in Denmark, Norway, Poland, Slovakia, and Sweden. Patients with documented atrial fibrillation (AF) but currently in stable sinus rhythm for ≥2 hours and ≤90 days were eligible for inclusion. Patients were randomized in a 1:1:1 ratio to receive AZD1305 extended-release or matching placebo tablets as follows: group A - test dose 250mg, evening dose 125mg on day 1, maintenance dose 125mg twice daily; group B - test dose 500mg, placebo evening dose, maintenance dose 125mg twice daily; placebo group - placebo test and maintenance dose. Maintenance dosing was for 9 days. QTcF >550ms at any time during the in-patient phase or >500ms after discharge (day 4) were predefined study drug discontinuation criteria. The main outcome measure was the relationship between QTcF following the test dose and during maintenance treatment. Results: Sixty-five patients were randomized (n=21, 22, and 22 in group A, group B, and the placebo group, respectively). AZD1305 dose-dependently increased QTcF. There was a positive, linear correlation between the change in QTcF during the first 6 hours after the test dose and during the maintenance phase. Three patients, all from group B, discontinued treatment on day 1 due to QTcF >550ms. All other patients completed the study without events related to QT prolongation. There was a trend for reduced AF recurrence with AZD1305 compared with placebo. Conclusion: In this exploratory study a test dose predicted the QT response during maintenance treatment with AZD1305 and may thus be employed in further studies. [ClinicalTrials.gov Identifier: NCT00643448].
40.	Flemme, Inger, et al. (author) Life situation of patients with an implantable cardioverter defibrillator : a descriptive longitudinal study 2001 In: Journal of Clinical Nursing. - : Wiley. - 0962-1067 .- 1365-2702. ; 10:4, s. 563-572 Journal article (peer-reviewed)abstract • The aim of this study was to describe changes in the life situation of patients with an implantable cardioverter defibrillator over a period of 1 year. A sample of 56 consecutive patients took part in the study.• Life situation was measured through uncertainty in illness, satisfaction, and fear of the life situation. Descriptive statistics were used to present results, and analytical statistics were used to map out changes over time.• Overall uncertainty showed a decrease over time. A statistically significant difference was found within the domain uncertainty related to information (P < 0.001).• Satisfaction increased within the domains health-functioning, socio-economic, psychological–spiritual, and family.• The ability to act within the domain health-functioning showed a statistical significance (P < 0.05).• The domain life changes within fear in the life situation decreased and showed a statistical significance (P < 0.05).• The overall life situation showed increased satisfaction as well as lower uncertainty and fear in the life situation.• The research indicates that patients need more information about changes in the life situation after the implantable cardioverter defibrillator-implantation. The study encourages more humanistic, holistic research about patients’ life situations as well as more education in teaching skills for health care personnel.
41.	Flemme, Inger, 1947-, et al. (author) Living with life-saving technology : long-term follow-up of recipients with implantable cardioverter defibrillator 2010 Conference paper (peer-reviewed)abstract The evidence that treatment of life-threatening arrhythmia (LTA) with an Implantable Cardioverter Defibrillator (ICD) can prolong life is convincing. Living with a lifelong heart disease will gradually influence the everyday life and encompasses some or all aspects of life. In order to influence health outcomes, the impact of the ICD must be considered in a broader context including not only the physical, but also the psychological and social functioning of the individual.The general aim of this thesis was to describe everyday life in recipients living with an ICD in a longterm perspective. The aim in Paper I was to describe changes in the life situation of recipients’ with an ICD over a period of 1 year. The aim in Paper II was to describe quality of life (QOL) and uncertainty in recipients who have an ICD and to predict QOL at long-term follow-up. Fifty-six recipients participated (I) and 35 of these recipients, who had survived at least five years, were further included (II). The Quality of Life Index-Cardiac version (I, II), Mishel Uncertainty in Illness Scale-Community version (I, II), Patient ICD Questionnaire (I) and multiple regression analysis (II) were used. Higher scores indicate higher QOL and uncertainty. The questionnaires were completed before implantation, three and twelve months after implantation (I) and also five years after implantation i.e. long-term follow up (II). At the long-term follow up, the average ICD recipient had lived with an ICD for six years and nine months (6.9 years). The results showed the overall QOL and QOL in the health/functioning domain were unchanged over time. QOL in the socio-economic (p= .002) and psychological/spiritual domains (p= .012) decreased in the first year. From baseline to long-term follow up, the QOL in the family domain (p= .011) and overall uncertainty (p= .002) decreased. Uncertainty related to the information decreased at year 1 in relation to baseline (p= .001).The aim in Paper III was to illuminate the main concern of recipients living with an ICD and how they handle this in their daily life. Sixteen recipients who had lived with an ICD between six to twenty-four months were interviewed. Data was collected and analysed in a simultaneous process according to guidelines for classical grounded theory. In the analysis, a substantive theory was generated explaining the main concern of ICD recipients and how they handle this in their daily life. The core category, labelled “Striving to resume command”, illuminates the main concern of ICD recipients. To manage this main concern, the recipients used the following strategies: Economizing resources, Distracting oneself, Submitting to one’s fate and Re-evaluating life.The aim in Paper IV was to explore relationships between OQL, coping strategies, anxiety, depression and perceived control in recipients living with an ICD and to compare those having received an ICD less or more than one year ago and those with a primary or secondary preventive indication. A cross-sectional, correlational, multicenter design was used, and 147 recipients who had lived with an ICD between six to twenty-four months completed Quality of Life Index-Cardiac version, Jalowiec Coping Scale, Hospital Anxiety and Depression Scale and Control Attitude Scale. The results showed that anxiety, depression and perceived control were predictors of QOL. Anxiety was also a predictor of coping with optimistic coping being the most used coping strategy. There was no relationship between QOL and coping. No differences were found in QOL, coping, anxiety, depression and perceived control between recipients implanted either on a primary or secondary preventive indication or having the device less or more than one year.In this thesis, it was concluded that the ICD recipients strived to resume command over their life (III) and the more control the recipients perceived the more satisfied they were with their QOL (IV) and the more symptoms of anxiety, depression and uncertainty they experienced the less satisfied they were with their QOL (II, IV). Coping strategies were used more frequently by ICD recipient perceiving more anxiety (IV). QOL was fairly good 6,9 years after implantation and ICD recipients felt less uncertain once they had passed the first year of their illness.
42.	Flemme, Inger, 1947-, et al. (author) Livskvalitet och upplevda chocker under ICD-behandling : en 5-års uppföljning 2004 Conference paper (peer-reviewed)abstract ICD–behandling ökar överlevnaden hos patienter (pat), som har överlevt en malign ventrikulär tachyarytmi. Pats livskvalitet (QoL) har angivits variera betydande och långtidseffekterna är ännu mindre väl kända. Vi följde ett antal konsekutiva pat under minst 5 år med avseende på livskvaliteten.Metod. Pat undersöktes med MUIS-C (Mishel Uncertainty in Illness Scale – community version) och QLI-CV (Quality of Life Index – cardiac version) och multipel regressionsanalys användes hos 35 patienter. Formulären fylldes i vid tre tillfällen: före implantationen, efter 1 och 5 år. Pats egen uppfattning om antalet upplevda chocker oavsett anledning noterades.Patienter. Ur en grupp pat, som tidigare undersöktes efter 1 år, hade 39 pat överlevt med sin ICD i minst 5 år. Av dessa avböjde tre deltagande i uppföljningen utan orsak och en pga cancer. Alla pat hade fått sin ICD på indikationen sekundär prevention. Resultat. Under det första året rapporterade 13 pat totalt 79 chocker och 22 pat ingen chock. Tio pat hade ingen chock vare sig efter 1 eller 5 år, och deras QoL var likvärdig med dem som hade haft ≤5 chocker. Tre pat rapporterade ≥6 chocker och hade sänkt QoL. Mellan år 1 och 5 rapporterade 20 pat 94 shocker och 15 pat ingen shock. Det var ingen skillnad mellan pat med eller utan chocker i deras QoL år 5 vs. år 1. Pat med chocker blev mindre besvärade med tiden.QoL var generellt sänkt år 1 vs baseline. En försämring i den socio-ekonomiska domänen sågs år 1 men var förbättrad år 5. En försämring i familjedomänen var oförändrad vid 1 och 5 år vs. baseline. En förbättring av otrygghet noterades vid 5 år vs år 1.Konklusioner. Pat med ICD mådde bättre år 5 än år 1 efter implantationen. Livskvaliteten var rimligt god 5 år efter implantationen och pat kände sig mer trygga och upplevde sin ICD som en livräddare. Pat med många chocker under det första året mådde sämre än övriga. Under resten av observationsperioden var chocktätheten lägre, möjligen delvis pga farmakologisk behandling, och pat upplevde mindre besvär av chockerna.
43.	Flemme, Inger, et al. (author) Long-term quality of life and uncertainty in patients living with an implantable cardioverter defibrillator. 2005 In: Heart & lung : the journal of critical care. - St. Louis, MO : Elsevier BV. - 0147-9563 .- 1527-3288. ; 34:6, s. 386-92 Journal article (peer-reviewed)abstract PURPOSE: This study describes the quality of life (QOL) and uncertainty in patients who have an implantable cardioverter defibrillator (ICD) and predicts QOL at long-term follow-up. METHODS: Long-term follow-up was defined as 6.9 years +/- 1 year (range 4.11-8.7 years). QOL was measured with the Quality of Life Index, and uncertainty was measured with the Mishel Uncertainty in Illness Scale. RESULTS: The overall QOL and health/functioning were unchanged over time. QOL in the socioeconomic (P = .002) and psychologic/spiritual domains (P = .012) decreased in the first year. From baseline to long-term follow-up, the QOL in the family domain (P = .011) and uncertainty (P = .002) decreased. Uncertainty was a predictor of low QOL. CONCLUSION: QOL was reasonably good 6.9 years post-ICD implantation. Patients felt less uncertain once they had passed the first year of their illness.
44.	Flemme, Inger, et al. (author) Quality of life in relation to ICD shocks and uncertainty in patients living with an ICD : a 5-year old follow-up Other publication (other academic/artistic)abstract Aim: To describe quality of life (QoL) in relation to ICD (implantable cardioverter defibrillator) shocks and uncertainty in patients living with an ICD and to identify QoL predictors over a 5-year period.Methods: The Mishel Uncertainty in Illness Scale and Quality of Life Index were used for 35 patients. Higher scores indicate higher uncertainty and QoL.Results: From baseline to year 1, QoL overall (p = 0.033) and in the socioeconomic domain (p = 0.006) decreased. From year 1 to 5, QoL in the socioeconomic domain increased (p = 0.027) but decreased in the family domain (p = 0.039) as did uncertainty (p = 0.009). From baseline to year 5, uncertainty (p = 0.009) and QoL in the family domain decreased (p = <0.001). Patients reporting few ICD shocks were less troubled over time, thus uncertainty is a predictor of decreased QoL.Conclusion: ICD-patients felt better at year 5 than year 1. QoL was reasonably good 5 years post-implant, and patients felt more certain and perceived the ICD as a lifesaver.
45.	Flemme, Inger, 1947-, et al. (author) Quality of life related to shocks in ICD-recipients : a 5-year follow-up 2006 In: 6th Annual Spring Meeting of the Working Group on Cardiovascular Nursing of the European Society of Cardiology and the Spring Meeting of the Norwegian National Society of Cardiovascular Nurses Bergen, Norway 5–6 May 2006. - London : Sage Publications. ; , s. S20-S20 Conference paper (peer-reviewed)abstract Purpose: The purpose of this study was to describe QoL in relation to shocks and uncertainty in ICD-recipients and to identify predictors of QoL over a 5-year period. Methods: The design was prospective and longitudinal. Thirty-five patients who had lived with the ICD for at least five years had taken part in the study. All recipients had received their ICD as a form of secondary prevention. The questionnaires Mishel Uncertainty in Illness Scale – community version (MUIS-C), Quality of Life Index – cardiac version (QLI-CV) were completed on three occasions: before implantation, at year 1 and at year 5 after implantation. Self-reported number of shocks between the implantation and year 1 and between year 1 and year 5 were described. Data were analyzed by descriptive as well as analytical statistics. Results: In general, QoL was lower at year 1 than before implantation (p = 0.033). A decrease in the socio-economic domain was observed at year 1 (p = 0.006) but improved again at year 5 (p = 0.027) although it remained below the value before implantation. ICD recipient’s satisfaction with the family domain decreased from the time before ICD implantation (p = < 0.001) and from year 1 (p = 0.039) to year 5 after implantation. A decrease in overall uncertainty was observed at year 5 in relation to year 1 (p = 0.009). The longer the ICD recipient had lived with the device, the greater the risk of receiving a shock. However, ICD recipients who received shocks reported being less troubled by them over time. Uncertainty was identified as a predictor of low QoL. Conclusion: The recipients reported a higher level of QoL at year 5 than at year 1. QoL was reasonably good 5 years after implantation and the ICD recipient felt more secure and perceived their ICD as a lifesaver.
46.	Flemme, Inger, et al. (author) Quality of profile 1 and 5 years after ICD implantation 2004 In: European Journal of Cardiovascular Nursing. - Amsterdam : Elsevier. - 1873-1953. Conference paper (peer-reviewed)abstract Aim: Treatment with implantable cardioverter defibrillators (ICDs) increases survival in patients suffering from ventricular tachyarrhythmias. The physiologic effects of having an ICD implanted are well-known but there is still limited knowledge about quality of life (QoL), especially in a long-term perspective. Therefore, the aim of this prospective, follow-up study was to describe and compare uncertainty and QoL at year 1 and year 5 after implantation in patients living with an ICD.Methods: The Mishel Uncertainty in Illness Scale-community version (MUIS-C) and Quality of Life Index-cardiac version (QLI) was used for 35 patients, living with an ICD in average 6 years 9 months. Higher scores indicate higher uncertainty and QoL.Results: An improvement in uncertainty was found at year 5 compared to year 1 (p=0.009), and at year 5 compared to baseline (p = 0.009). Overall QoL decreased at year 1 compared to baseline (p = 0.033). QoL in the socioeconomic domain decreased at year 1 compared to baseline (p = 0.006), and increased at year 5 compared to year 1 (p=0.027). QoL in the family domain decreased at year 5 compared to year 1 (p=0.039), and at year 5 compared to baseline (p=<0.001).Conclusion: Patients with ICD feel better at year 5 than at year 1. The QoL is reasonable good 5 years after implant once they have passed the first years and adapted to lifestyle changes, and patients are more certain and perceive the ICD as a parachute of life.
47.	Friberg, L., et al. (author) The prognosis of patients with atrial fibrillation is improved when sinus rhythm is restored: report from the Stockholm Cohort of Atrial Fibrillation (SCAF) 2009 In: Heart. - 1468-201X. ; 95:12, s. 1000-5 Journal article (peer-reviewed)abstract BACKGROUND: Clinical trials have indicated that an active rhythm control strategy aiming at restoration of sinus rhythm in patients with atrial fibrillation (AF) is no better than a rate-control strategy in terms of mortality and morbidity. To what extent restoration and maintenance of sinus rhythm per se affect long-term prognosis in AF patients is less clear. AIM: To investigate if there are differences in mortality and morbidity between direct current (DC)-cardioverted AF patients who remain in sinus rhythm after cardioversion and those who relapse early. Method: 361 cardioverted patients from the Stockholm Cohort Study on Atrial Fibrillation were studied by means of medical records and national registers. Patients were followed for a mean of 4.2 years from DC cardioversion regarding all-cause mortality and for a mean of 3.2 years for a composite endpoint of death, ischaemic stroke, myocardial infarction or hospitalisation for heart failure. RESULTS: All-cause mortality tended to be lower in patients who had been successfully cardioverted and had had no known relapse of AF within the first 3 months after cardioversion (hazard ratio (HR) 0.57, 95% CI 0.30 to 1.06, p = 0.076). They also had a significantly lower incidence of the composite endpoint than those who relapsed early (HR 0.51, 95% CI 0.32 to 0.82, p = 0.0058). CONCLUSION: Restoration and 3 months maintenance of sinus rhythm was associated with improved long-term prognosis. The results imply that an active DC cardioversion approach is justified.
48.	Gal, P., et al. (author) First Clinical Study with AP30663-a K(Ca)2 Channel Inhibitor in Development for Conversion of Atrial Fibrillation 2020 In: Cts-Clinical and Translational Science. - : Wiley. - 1752-8054 .- 1752-8062. ; 13:6, s. 1336-1344 Journal article (peer-reviewed)abstract Pharmacological cardioversion of atrial fibrillation (AF) is frequently inefficacious. AP30663, a small conductance Ca(2+)activated K+(K(Ca)2) channel blocker, prolonged the atrial effective refractory period in preclinical studies and subsequently converted AF into normal sinus rhythm. This first-in-human study evaluated the safety and tolerability, and pharmacokinetic (PK) and pharmacodynamic (PD) effects were explored. Forty-seven healthy male volunteers (23.7 +/- 3.0 years) received AP30663 intravenously in ascending doses. Due to infusion site reactions, changes to the formulation and administration were implemented in the latter 24 volunteers. Extractions from a 24-hour continuous electrocardiogram were used to evaluate the PD effect of AP30663. Data were analyzed with a repeated measure analysis of covariance, noncompartmental analysis, and concentration-effect analysis. In total, 33 of 34 adverse events considered related to AP30663 exposure were related to the infusion site, mild in severity, and temporary in nature, although full recovery took up to 110 days. After formulation and administration changes, the local infusion site reaction remained, but the median duration was shorter despite higher dose levels. AP30663 displayed a less than dose proportional increase in peak plasma concentration (C-max) and a terminal half-life of around 5 hours. In healthy volunteers, no effect of AP30663 was observed on electrocardiographic parameters, other than a concentration-dependent effect on the corrected QT Fridericia's formula interval (+18.8 +/- 4.3 ms for the highest dose level compared with time matched placebo). In conclusion, administration of AP30663, a novel K(Ca)2 channel inhibitor, was safe and well-tolerated systemically in humans, supporting further development in patients with AF undergoing cardioversion.
49.	Gold, Michael R, et al. (author) Impact of atrial prevention pacing on atrial fibrillation burden: primary results of the Study of Atrial Fibrillation Reduction (SAFARI) trial. 2009 In: Heart rhythm : the official journal of the Heart Rhythm Society. - : Elsevier BV. - 1556-3871. ; 6:3, s. 295-301 Journal article (peer-reviewed)abstract BACKGROUND: The role of atrial-based pacing algorithms in preventing atrial fibrillation (AF) remains controversial. The inconsistent results noted in previous trials may be due in part to differences in endpoints, pacing algorithms, and study design. SAFARI, a worldwide, prospective, randomized clinical trial, was designed to address these issues and to evaluate the safety and efficacy of a suite of prevention pacing therapies (PPTs) among patients with paroxysmal AF. METHODS AND RESULTS: Patients who met standard pacemaker indications and documented symptomatic AF were implanted with a pacemaker (Vitatron Selection 9000). At 4 months, only patients with documented AF despite dual-chamber pacing were randomized to PPTs ON or PPTs OFF and followed for 6 months. Incidence of permanent AF and change in AF burden were compared between the two groups. Among the 555 patients enrolled, 240 had AF burden at 4 months and were randomized. The risk of developing permanent AF was similar in both groups (0 in the PPTs ON group vs. 3 in the OFF group). However, there was a significant reduction in AF burden between baseline and 10-month follow-up in the ON group compared with the OFF group (median decrease of 0.08 hours/day vs no change, P = .03). CONCLUSION: Among patients with paroxysmal AF and standard bradycardia indications, PPTs are safe and associated with less AF burden compared with conventional pacing.
50.	Gottfridsson, Christer, 1958, et al. (author) Acute evaluation of transthoracic impedance vectors using ICD leads. 2009 In: Pacing and clinical electrophysiology : PACE. - : Wiley. - 1540-8159 .- 0147-8389. ; 32:6, s. 762-71 Journal article (peer-reviewed)abstract BACKGROUND: Minute ventilation (MV) has been proven to be very useful in rate responsive pacing. The aim of this study was to evaluate the feasibility of using implantable cardioverter-defibrillator (ICD) leads as part of the MV detection system. METHODS: At implant in 10 patients, the transthoracic impedance was measured from tripolar ICD, tetrapolar ICD, and atrial lead vectors during normal, deep, and shallow voluntary respiration. MV and respiration rate (RespR) were simultaneously measured through a facemask with a pneumotachometer (Korr), and the correlations with impedance-based measurements were calculated. Air sensitivity was the change in impedance per change in respiratory tidal volume, ohms (Omega)/liter (L), and the signal-to-noise ratio (SNR) was the ratio of the respiratory and cardiac contraction components. RESULTS: The air sensitivity and SNR in tripolar ICD vector were 2.70 +/- 2.73 ohm/L and 2.19 +/- 1.31, respectively, and were not different from tetrapolar. The difference in RespR between tripolar ICD and Korr was 0.2 +/- 1.91 breaths/minute. The regressed correlation coefficient between impedance MV and Korr MV was 0.86 +/- 0.07 in tripolar ICD. CONCLUSIONS: The air sensitivity and SNR in tripolar and tetrapolar ICD lead vectors did not differ significantly and were in the range of the values in pacemaker leads currently used as MV sensors. The good correlations between impedance-based and Korr-based RespR and MV measurements imply that ICD leads may be used in MV sensor systems.

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