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  • 1. Ahmed, Fozia Z.
    et al.
    Blomström-Lundqvist, Carina
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology-Arrhythmia.
    Bloom, Heather
    Cooper, Christopher
    Ellis, Christopher
    Goette, Andreas
    Greenspon, Arnold J.
    Love, Charles J.
    Johansen, Jens Brock
    Philippon, Francois
    Tarakji, Khaldoun G.
    Holbrook, Reece
    Sherfesee, Lou
    Xia, Ying
    Seshadri, Swathi
    Lexcen, Daniel R.
    Krahn, Andrew D.
    Use of healthcare claims to validate the Prevention of Arrhythmia Device Infection Trial cardiac implantable electronic device infection risk score2021In: Europace, ISSN 1099-5129, E-ISSN 1532-2092, Vol. 23, no 9, p. 1446-1455Article in journal (Refereed)
    Abstract [en]

    AIM: The Prevention of Arrhythmia Device Infection Trial (PADIT) infection risk score, developed based on a large prospectively collected data set, identified five independent predictors of cardiac implantable electronic device (CIED) infection. We performed an independent validation of the risk score in a data set extracted from U.S. healthcare claims.

    METHODS AND RESULTS: Retrospective identification of index CIED procedures among patients aged ≥18 years with at least one record of a CIED procedure between January 2011 and September 2014 in a U.S health claims database. PADIT risk factors and major CIED infections (with system removal, invasive procedure without system removal, or infection-attributable death) were identified through diagnosis and procedure codes. The data set was randomized by PADIT score into Data Set A (60%) and Data Set B (40%). A frailty model allowing multiple procedures per patient was fit using Data Set A, with PADIT score as the only predictor, excluding patients with prior CIED infection. A data set of 54 042 index procedures among 51 623 patients with 574 infections was extracted. Among patients with no history of prior CIED infection, a 1 unit increase in the PADIT score was associated with a relative 28% increase in infection risk. Prior CIED infection was associated with significant incremental predictive value (HR 5.66, P < 0.0001) after adjusting for PADIT score. A Harrell's C-statistic for the PADIT score and history of prior CIED infection was 0.76.

    CONCLUSION: The PADIT risk score predicts increased CIED infection risk, identifying higher risk patients that could potentially benefit from targeted interventions to reduce the risk of CIED infection. Prior CIED infection confers incremental predictive value to the PADIT score.

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  • 2. Aktaa, Suleman
    et al.
    Abdin, Amr
    Arbelo, Elena
    Burri, Haran
    Vernooy, Kevin
    Blomström-Lundqvist, Carina
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology-Arrhythmia.
    Boriani, Giuseppe
    Defaye, Pascal
    Deharo, Jean-Claude
    Drossart, Inga
    Foldager, Dan
    Gold, Michael R
    Johansen, Jens Brock
    Leyva, Francisco
    Linde, Cecilia
    Michowitz, Yoav
    Kronborg, Mads Brix
    Slotwiner, David
    Steen, Torkel
    Tolosana, José Maria
    Tzeis, Stylianos
    Varma, Niraj
    Glikson, Michael
    Nielsen, Jens Cosedis
    Gale, Chris P
    European Society of Cardiology Quality Indicators for the care and outcomes of cardiac pacing: developed by the Working Group for Cardiac Pacing Quality Indicators in collaboration with the European Heart Rhythm Association of the European Society of Cardiology2022In: Europace, ISSN 1099-5129, E-ISSN 1532-2092, Vol. 24, no 1, p. 165-172Article in journal (Refereed)
    Abstract [en]

    AIMS: To develop a suite of quality indicators (QIs) for the evaluation of the care and outcomes for adults undergoing cardiac pacing.

    METHODS AND RESULTS: Under the auspice of the Clinical Practice Guideline Quality Indicator Committee of the European Society of Cardiology (ESC), the Working Group for cardiac pacing QIs was formed. The Group comprised Task Force members of the 2021 ESC Clinical Practice Guidelines on Cardiac Pacing and Cardiac Resynchronization Therapy, members of the European Heart Rhythm Association, international cardiac device experts, and patient representatives. We followed the ESC methodology for QI development, which involved (i) the identification of the key domains of care by constructing a conceptual framework of the management of patients receiving cardiac pacing, (ii) the development of candidate QIs by conducting a systematic review of the literature, (iii) the selection of the final set of QIs using a modified-Delphi method, and (iv) the evaluation of the feasibility of the developed QIs. Four domains of care were identified: (i) structural framework, (ii) patient assessment, (iii) pacing strategy, and (iv) clinical outcomes. In total, seven main and four secondary QIs were selected across these domains and were embedded within the 2021 ESC Guidelines on Cardiac Pacing and Cardiac Resynchronization therapy.

    CONCLUSION: By way of a standardized process, 11 QIs for cardiac pacing were developed. These indicators may be used to quantify adherence to guideline-recommended clinical practice and have the potential to improve the care and outcomes of patients receiving cardiac pacemakers.

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  • 3. Amara, Walid
    et al.
    Larsen, Torben B
    Sciaraffia, Elena
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology-Arrhythmia.
    Hernández Madrid, Antonio
    Chen, Jian
    Estner, Heidi
    Todd, Derick
    Bongiorni, Maria G
    Potpara, Tatjana S
    Dagres, Nikolaos
    Sagnol, Pascal
    Blomstrom-Lundqvist, Carina
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology-Arrhythmia.
    Patients' attitude and knowledge about oral anticoagulation therapy: results of a self-assessment survey in patients with atrial fibrillation conducted by the European Heart Rhythm Association.2016In: Europace, ISSN 1099-5129, E-ISSN 1532-2092, Vol. 18, no 1, p. 151-155Article in journal (Refereed)
    Abstract [en]

    The purpose of this European Heart Rhythm Association survey was to assess the attitude, level of education, and knowledge concerning oral anticoagulants (OACs) among patients with atrial fibrillation (AF) taking vitamin K antagonists (VKAs), non-VKA oral anticoagulants (NOACs) or antiplatelets. A total of 1147 patients with AF [mean age 66 ± 13 years, 529 (45%) women] from 8 selected European countries responded to this survey. The overall use of OACs and antiplatelets was 77 and 15.3%, respectively. Of the patients taking OACs, 67% were on VKAs, 33% on NOACs, and 17.9% on a combination of OACs and antiplatelets. Among patients on VKAs, 91% correctly stated the target international normalized ratio (INR) level. The proportion of patients on VKA medication who were aware that monthly INR monitoring was required for this treatment and the proportion of patients on NOAC who knew that renal function monitoring at least annually was mandatory for NOACs was 76 and 21%, respectively. An indirect estimation of compliance indicated that 14.5% of patients temporarily discontinued the treatment, and 26.5% of patients reported having missed at least one dose. The survey shows that there is room for improvement regarding education and adherence of patients taking OACs, particularly regarding monitoring requirements for NOACs.

  • 4.
    Anselmino, Matteo
    et al.
    Univ Turin, Citta Salute & Sci TorinoHosp, Dept Med Sci, Div Cardiol, Turin, Italy..
    Ballatore, Andrea
    Univ Turin, Citta Salute & Sci TorinoHosp, Dept Med Sci, Div Cardiol, Turin, Italy..
    Saglietto, Andrea
    Univ Turin, Citta Salute & Sci TorinoHosp, Dept Med Sci, Div Cardiol, Turin, Italy..
    Stabile, Giuseppe
    Clin Montevergine, Mercogliano, Italy..
    De Ponti, Roberto
    Casa Cura San Michele, Maddaloni, Italy.;Univ Insubria, Dept Heart & Vessels, Osped Circolo, Varese, Italy..
    Grimaldi, Massimo
    Osped Gen Reg F Muilli, Dept Cardiol, Acquaviva Delle Fonti, Italy..
    Agricola, Pietro M. G.
    Casa Cura Privata Piacenza, Unita Operat Cardiol, Piacenza, Italy..
    Della Bella, Paolo
    Ist Sci San Raffaele, Electrophysiol Lab, Milan, Italy.;Ist Sci San Raffaele, Arrhythmia Unit, Milan, Italy..
    Tritto, Massimo
    Ist Clin Humanitas Mater Domini, Castellanza, Italy..
    Pappone, Carlo
    IRCCS Policlin San Donato, Arrhythmol Dept, Milan, Italy..
    Calo, Leonardo
    Policlin Casilino, Div Cardiol, Rome, Italy..
    Bongiorni, Maria G.
    Univ Hosp Pisa, CardioThorac & Vasc Dept, Div Cardiol & Arrhythmol, Pisa, Italy..
    Blomström-Lundqvist, Carina
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology-Arrhythmia.
    Gaita, Fiorenzo
    Clin Pinna Pintor, Cardiol Dept, I-10129 Turin, Italy..
    De Ferrari, Gaetano M.
    Univ Turin, Citta Salute & Sci TorinoHosp, Dept Med Sci, Div Cardiol, Turin, Italy..
    Atrial fibrillation ablation long-term ESC-EHRA EORP AFA LT registry: in-hospital and 1-year follow-up findings in Italy2020In: Journal of Cardiovascular Medicine, ISSN 1558-2027, E-ISSN 1558-2035, Vol. 21, no 10, p. 740-748Article in journal (Refereed)
    Abstract [en]

    Aim: To report the Italian data deriving from the European Society of Cardiology-EURObservational Research Program atrial fibrillation ablation long-term registry.

    Methods and results: Ten Italian centers enrolled up to 50 consecutive patients undergoing atrial fibrillation ablation. Of the 318 patients included, 5 (1.6%) did not undergo catheter ablation, 1 had ablation partially done and 62 were lost at 1-year follow-up. Women were less represented (23.6%) and the median age was 60.0 years. A total of 195 patients (62.3%) suffered paroxysmal atrial fibrillation, whereas only 9 (2.9%) had long-standing persistent atrial fibrillation. Most Italian patients (92.3%) were symptomatic but suffering fewer symptomatic events than patients enrolled in other countries (median of two events in the month preceding the ablation vs. three, respectively; P<0.0001). The main finding of the study is that the success rate at 1 year, with and without antiarrhythmic drugs, was 76.4%, consistently with other participating countries (73.4%). This result was obtained however, with a significantly lower prevalence of 1-year adverse events (7.3 vs. 16.6%, P<0.0001). Procedure duration and fluoroscopy total time resulted as being shorter in Italy (145 vs. 160, P=0.0005 and 16.9 vs. 20.0 min, P=0.0018, respectively); however, the radiation dose per BSA was greater (37.5 vs. 26.0mGy/cm(2), P=0.0022).

    Conclusion: The demographic characteristics of patients undergoing atrial fibrillation ablation are similar to those reported in other countries. The success rate in Italy is consistent with those in other countries, whereas the complications rate is lower.

  • 5.
    Arvanitis, Panagiotis
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology-Arrhythmia.
    Clinical evaluation and implications of left atrial remodeling in atrial fibrillation: From silent cerebral lesions and atrial stunning to novel electrocardiographic tools for prediction of arrhythmia outcome2023Doctoral thesis, comprehensive summary (Other academic)
    Abstract [en]

    Atrial fibrillation (AF) is the most common cardiac arrhythmia. Left atrial (LA) remodeling and reverse remodeling are associated with cerebral involvement and cognitive function (CF) changes. Risk stratification for AF related outcomes is essential in the management of patients with AF. 

    This thesis aimed to 1) explore the effects of AF in a prospective cohort of anticoagulant-naïve patients, who underwent cardioversion (CV) within 48 hours after debut (Studies I and II) on i) occurrence of new silent thromboembolic events using brain magnetic resonance imaging, CF, cerebral biomarker ii) atrial remodeling and thrombogenicity using echocardiography, and hypercoagulability biomarkers; 2) identify novel electrocardiographic (ECG) predictors of 12-months AF recurrence, (Study III), in patients with non-permanent AF after CV or pulmonary vein isolation and study its effect on reverse atrial electrical remodeling (RAER) and 3) to evaluate traditional and novel ECG- and clinical predictors of new-onset AF (new-o-AF) on hospitalized Covid-19 patients (Study IV)  and explore the impact of AF on clinical outcomes.

    In Papers I and II, acute silent cerebral lesions could not be identified. A higher incidence of white matter hyperintensities was associated with higher CHA2DS2-VASc-score. A transient increase in cerebral damage biomarker was observed. Persistent AF patients had inferior CF test results. LA stunning resolved within ten days. The reverse functional remodeling was incomplete in patients with AF history. Higher levels of hypercoagulability-related biomarkers were observed prior to CV. 

    In Paper III, the novel Peq-time>33ms, from P-wave onset to the peak positive deflection, independently predicted 12-months AF recurrence. The P-leftward-area, from peak positive deflection to the offset of P-wave, showed the largest change during follow-up, describing RAER. Machine-learning predictive model including variables from the novel P-wave partitioning showed the best predictive performance.

    In Paper IV, the novel Peq-time>33ms, PR-interval>190ms and P-wave-duration>115ms were independent predictors of n-o-AF. Admission to the intensive care unit (ICU), need for respiratory support, advanced age, males and increased body mass index (BMI) independently predicted new-o-AF. Logistic regression predictive models including age, sex, BMI, ICU admission and Peq-time or PR-interval had the best balanced accuracy.

    In conclusion, our findings in Studies I and II might suggest an enhanced thrombogenicity, even in patients with low stroke risk, supporting the concept of anticoagulation pericardioversion. We introduced the novel Peq-time, independently predicting AF recurrence in Study III and, along with PR-interval, new-o-AF in Study IV. Predictive models of arrhythmia outcome could be implemented in individually-tailored AF management and surveillance.

    List of papers
    1. Serial Magnetic Resonance Imaging after Electrical Cardioversion of Recent Onset Atrial Fibrillation in Anticoagulant-Naïve Patients –: A Prospective Study Exploring Clinically Silent Cerebral Lesions
    Open this publication in new window or tab >>Serial Magnetic Resonance Imaging after Electrical Cardioversion of Recent Onset Atrial Fibrillation in Anticoagulant-Naïve Patients –: A Prospective Study Exploring Clinically Silent Cerebral Lesions
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    2020 (English)In: Journal of Atrial Fibrillation, ISSN 1941-6911, Vol. 13, no 2Article in journal (Refereed) Published
    Place, publisher, year, edition, pages
    Cardiofront, 2020
    Keywords
    Silent brain lesions, Atrial fibrillation, Cognitive function, Cardioversion.
    National Category
    Cardiac and Cardiovascular Systems
    Research subject
    Medical Science
    Identifiers
    urn:nbn:se:uu:diva-429683 (URN)
    Available from: 2021-01-01 Created: 2021-01-01 Last updated: 2023-04-24Bibliographically approved
    2. Recent-onset atrial fibrillation: a study exploring the elements of Virchow's triad after cardioversion
    Open this publication in new window or tab >>Recent-onset atrial fibrillation: a study exploring the elements of Virchow's triad after cardioversion
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    2022 (English)In: Journal of Interventional Cardiac Electrophysiology, ISSN 1383-875X, E-ISSN 1572-8595, Vol. 64, no 1, p. 49-58Article in journal (Refereed) Published
    Abstract [en]

    Purpose

    Atrial fibrillation (AF) imposes an inherent risk for stroke and silent cerebral emboli, partly related to left atrial (LA) remodeling and activation of inflammatory and coagulation systems. The aim was to explore the effects of cardioversion (CV) and short-lasting AF on left atrial hemodynamics, inflammatory, coagulative and cardiac biomarkers, and the association between LA functional recovery and the presence of a prior history of AF.

    Methods

    Patients referred for CV within 48 h after AF onset were prospectively included. Echocardiography and blood sampling were performed immediately prior, 1–3 h after, and at 7–10 days after CV. The presence of chronic white matter hyperintensities (WMH) on magnetic resonance imaging was related to biomarker levels.

    Results

    Forty-three patients (84% males), aged 55±9.6 years, with median CHA2DS2-VASc score 1 (IQR 0–1) were included. The LA emptying fraction (LAEF), LA peak longitudinal strain during reservoir, conduit, and contractile phases improved significantly after CV. Only LAEF normalized within 10 days. Interleukin-6, high-sensitivity cardiac-troponin-T (hs-cTNT), N-terminal-pro-brain-natriuretic peptide, prothrombin-fragment 1+2 (PTf1+2), and fibrinogen decreased significantly after CV. There was a trend towards higher C-reactive protein, hs-cTNT, and PTf1+2 levels in patients with WMH (n=21) compared to those without (n=22). At 7–10 days, the LAEF was significantly lower in patients with a prior history of AF versus those without.

    Conclusion

    Although LA stunning resolved within 10 days, LAEF remained significantly lower in patients with a prior history of AF versus those without. Inflammatory and coagulative biomarkers were higher before CV, but subsided after 7–10 days, which altogether might suggest an enhanced thrombogenicity, even in these low-risk patients.

    Keywords
    Physiology: medical, Cardiology, Cardiovascular Medicine
    National Category
    Cardiac and Cardiovascular Systems
    Research subject
    Cardiology
    Identifiers
    urn:nbn:se:uu:diva-456899 (URN)10.1007/s10840-021-01078-9 (DOI)000710619700001 ()34689250 (PubMedID)
    Funder
    Swedish Heart Lung FoundationSwedish Research CouncilErik, Karin och Gösta Selanders FoundationUppsala University
    Available from: 2021-10-24 Created: 2021-10-24 Last updated: 2023-04-24Bibliographically approved
    3. Novel P-wave indices and machine learning predict atrial fibrillation recurrence after rhythm control interventions
    Open this publication in new window or tab >>Novel P-wave indices and machine learning predict atrial fibrillation recurrence after rhythm control interventions
    (English)Manuscript (preprint) (Other academic)
    Keywords
    Atrial fibrillation, Atrial fibrillation recurrence, P-wave indices, Pulmonary vein isolation, Cardioversion, Machine learning
    National Category
    Cardiac and Cardiovascular Systems
    Identifiers
    urn:nbn:se:uu:diva-500678 (URN)
    Available from: 2023-04-21 Created: 2023-04-21 Last updated: 2023-05-03
    4. Risk factors and electrocardiographic predictors associated with new-onset atrial fibrillation in hospitalized Covid-19 patients. Evaluation of a novel P-wave index.
    Open this publication in new window or tab >>Risk factors and electrocardiographic predictors associated with new-onset atrial fibrillation in hospitalized Covid-19 patients. Evaluation of a novel P-wave index.
    Show others...
    (English)Manuscript (preprint) (Other academic)
    Keywords
    New-onset atrial fibrillation, Covid-19, Risk factors, Electrocardiographic predictors, P-wave indices, Logistic regression predictive model
    National Category
    Cardiac and Cardiovascular Systems
    Identifiers
    urn:nbn:se:uu:diva-500681 (URN)
    Available from: 2023-04-21 Created: 2023-04-21 Last updated: 2023-05-03
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  • 6.
    Arvanitis, Panagiotis
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology-Arrhythmia.
    Biering-Sørensen, Tor
    Linde, Cecilia
    Malmborg, Helena
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology-Arrhythmia.
    Poole, Jeanne E.
    Sridhar, Arun R.
    Boyle, Patrick M.
    Blomström-Lundqvist, Carina
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology-Arrhythmia. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology.
    Risk factors and electrocardiographic predictors associated with new-onset atrial fibrillation in hospitalized Covid-19 patients. Evaluation of a novel P-wave index.Manuscript (preprint) (Other academic)
  • 7.
    Arvanitis, Panagiotis
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology-Arrhythmia. Uppsala University Hospital.
    Johannson, Anna-Karin
    Frick, Mats
    Malmborg, Helena
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology-Arrhythmia. Uppsala University Hospital.
    Gerovasileiou, Spyridon
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Clinical Physiology. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology. Uppsala University Hospital.
    Larsson, Elna-Marie
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Surgical Sciences, Radiology. Uppsala University Hospital.
    Blomström-Lundqvist, Carina
    Uppsala University Hospital.
    Serial Magnetic Resonance Imaging after Electrical Cardioversion of Recent Onset Atrial Fibrillation in Anticoagulant-Naïve Patients –: A Prospective Study Exploring Clinically Silent Cerebral Lesions2020In: Journal of Atrial Fibrillation, ISSN 1941-6911, Vol. 13, no 2Article in journal (Refereed)
  • 8.
    Arvanitis, Panagiotis
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology-Arrhythmia.
    Johansson, A. K.
    Frick, Mats
    Malmborg, Helena
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology-Arrhythmia.
    Gerovasileiou, Spyridon
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Clinical Physiology. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology.
    Larsson, Elna-Marie
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Surgical Sciences, Radiology.
    Blomström-Lundqvist, Carina
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology-Arrhythmia.
    Timing and degree of left atrial stunning and reverse functional remodeling following electrical cardioversion in patients with recent onset atrial fibrillation2020In: European Heart Journal, Supplement, ISSN 1520-765X, E-ISSN 1554-2815, Vol. 41, no Supplement_2, article id ehaa946.0465Article in journal (Other academic)
    Abstract [en]

    Background

    Atrial fibrillation (AF) results in left atrial electrical, structural and functional remodeling. Restoration of sinus rhythm hallmarks the beginning of reverse remodeling, the extent of which may depend on the type of AF.

    Purpose

    The aim of the study was to assess resumption of left atrial function after electric cardioversion in patients with recent onset AF and to explore the association between reverse remodeling and the type of atrial fibrillation.

    Methods

    Patients with AF duration <48 hours were prospectively included. Trans-thoracic echocardiography was performed prior, immediately after (2–4 hours) and 7–10 days following CV. Left atrial volume index (LAVI), left atrial global longitudinal strain during reservoir (LAGLS-res), conduit (LAGLS-cond) and contractile (LAGLS-contr) phases, left atrial ejection fraction (LAEF) and left ventricular ejection fraction (LVEF) were measured.

    Results

    Forty-three patients (84% males) aged 55±9.6 years, (mean±SD), with median CHA2DS2-VASc score 1 (interquartile range 0–1) were included. Repeated measure analysis of variance revealed a statistically significant overall change for LAGLS-res F(2,78)=55.4, p<0,001, LAGLS-cond F(2,78)=23.3, p<0,001, LAGLS-contr F(2,78)=39.7, p<0,001, LAEF F(2,80)=28.5, p<0.001 and LVEF F(2,80)=8.4, p<0.001. At 7–10 days, LAGLS-contr 12±4%, LAEF 53±9% and LVEF 60±6 (mean±SD) return within normal reference intervals. Notably left atrial recovery seems to precede left ventricular recovery. No statistical significant interaction with the type of atrial fibrillation could be shown.

    Conclusion

    Left atrial functional reverse remodeling occurs within ten days after successful electric cardioversion of patients with recent onset atrial fibrillation.

  • 9.
    Arvanitis, Panagiotis
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology-Arrhythmia.
    Johansson, Anna-Karin
    Frick, Mats
    Malmborg, Helena
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology-Arrhythmia.
    Gerovasileiou, Spyridon
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Clinical Physiology. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology.
    Larsson, Elna-Marie
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Surgical Sciences, Radiology.
    Blomström-Lundqvist, Carina
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology-Arrhythmia.
    Recent-onset atrial fibrillation: a study exploring the elements of Virchow's triad after cardioversion2022In: Journal of Interventional Cardiac Electrophysiology, ISSN 1383-875X, E-ISSN 1572-8595, Vol. 64, no 1, p. 49-58Article in journal (Refereed)
    Abstract [en]

    Purpose

    Atrial fibrillation (AF) imposes an inherent risk for stroke and silent cerebral emboli, partly related to left atrial (LA) remodeling and activation of inflammatory and coagulation systems. The aim was to explore the effects of cardioversion (CV) and short-lasting AF on left atrial hemodynamics, inflammatory, coagulative and cardiac biomarkers, and the association between LA functional recovery and the presence of a prior history of AF.

    Methods

    Patients referred for CV within 48 h after AF onset were prospectively included. Echocardiography and blood sampling were performed immediately prior, 1–3 h after, and at 7–10 days after CV. The presence of chronic white matter hyperintensities (WMH) on magnetic resonance imaging was related to biomarker levels.

    Results

    Forty-three patients (84% males), aged 55±9.6 years, with median CHA2DS2-VASc score 1 (IQR 0–1) were included. The LA emptying fraction (LAEF), LA peak longitudinal strain during reservoir, conduit, and contractile phases improved significantly after CV. Only LAEF normalized within 10 days. Interleukin-6, high-sensitivity cardiac-troponin-T (hs-cTNT), N-terminal-pro-brain-natriuretic peptide, prothrombin-fragment 1+2 (PTf1+2), and fibrinogen decreased significantly after CV. There was a trend towards higher C-reactive protein, hs-cTNT, and PTf1+2 levels in patients with WMH (n=21) compared to those without (n=22). At 7–10 days, the LAEF was significantly lower in patients with a prior history of AF versus those without.

    Conclusion

    Although LA stunning resolved within 10 days, LAEF remained significantly lower in patients with a prior history of AF versus those without. Inflammatory and coagulative biomarkers were higher before CV, but subsided after 7–10 days, which altogether might suggest an enhanced thrombogenicity, even in these low-risk patients.

    Download full text (pdf)
    fulltext
  • 10.
    Arvanitis, Panagiotis
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology-Arrhythmia.
    Mörtsell, David
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology-Arrhythmia.
    Blomström-Lundqvist, Carina
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology-Arrhythmia. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology.
    Novel P-wave indices and machine learning predict atrial fibrillation recurrence after rhythm control interventionsManuscript (preprint) (Other academic)
  • 11.
    Atar, Dan
    et al.
    Oslo Univ Hosp Ullevaal, Dept Cardiol, Kirkeveien 166, N-0450 Oslo, Norway.;Univ Oslo, Inst Clin Med, Kirkeveien 166,Soesterhjemmet, N-0450 Oslo, Norway..
    Auricchio, Angelo
    Inst Cardioctr Ticino, Div Cardiol, Clin Electrophysiol Unit, Lugano, Switzerland..
    Blomström-Lundqvist, Carina
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology-Arrhythmia. Örebro Univ, Fac Med & Hlth, Sch Med Sci, Dept Cardiol, Örebro, Sweden..
    Cardiac device infection: removing barriers to timely and adequate treatment2023In: European Heart Journal, ISSN 0195-668X, E-ISSN 1522-9645, Vol. 44, no 35, p. 3323-3326Article in journal (Other academic)
    Download full text (pdf)
    fulltext
  • 12.
    Auricchio, Angelo
    et al.
    ivision of Cardiology, Fondazione Cardiocentro Ticino, Lugano, Switzerland.
    Gasparini, Maurizio
    Department of Cardiology, Humanitas Research Hospital IRCCS, Rozzano, Italy.
    Linde, Cecilia
    Heart and Vascular Theme, Karolinska University Hospital and Karolinska Institutet, Stockholm, Sweden.
    Dobreanu, Dan
    Institute of Cardiovascular Disease and Transplant, University of Medicine and Pharmacy, Tîrgu Mureș, Romania.
    Cano, Óscar
    Electrophysiology Section, Cardiology Department, Hospital Universitari i Politècnic La Fe, Valencia, Spain.
    Sterlinski, Maciej
    Heart Rhythm Department, Institute of Cardiology, Warsaw, Poland.
    Bogale, Nigussie
    Department of Cardiology, Stavanger University Hospital, Stavanger, Norway.
    Stellbrink, Christoph
    Department of Cardiology, Klinikum Bielefeld, Bielefeld, Germany.
    Refaat, Marwan M
    Division of Cardiology, Department of Internal Medicine, Faculty of Medicine and Medical Center, American University of Beirut, Beirut, Lebanon.
    Blomström-Lundqvist, Carina
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology-Arrhythmia.
    Lober, Christiane
    Department of Statistics, IHF GmbH, Ludwigshafen, Germany.
    Dickstein, Kenneth
    Department of Cardiology, Stavanger University Hospital, Stavanger, Norway; Institute of Internal Medicine, University of Bergen, Bergen, Norway.
    Normand, Camilla
    Department of Cardiology, Stavanger University Hospital, Stavanger, Norway; Institute of Internal Medicine, University of Bergen, Bergen, Norway.
    Sex-Related Procedural Aspects and Complications in CRT Survey II: A Multicenter European Experience in 11,088 Patients2019In: JACC: Clinical Electrophysiology, ISSN 2405-500X, E-ISSN 2405-5018, Vol. 5, no 9, p. 1048-1058Article in journal (Refereed)
    Abstract [en]

    OBJECTIVES: This study sought to compare sex difference for procedural aspects and complications in the European Society of Cardiology CRT Survey II, exploring whether adverse events were related to the type of CRT device implanted.

    BACKGROUND: Sex-related differences in procedural aspects and complications in patients undergoing cardiac resynchronization therapy (CRT) implantation has not been explored in a real-life population.

    METHODS: A post-hoc analysis of procedural data and complications in different sexes and factors associated with events was performed from data collected in the European Society of Cardiology CRT Survey II.

    RESULTS: Of all patients (n = 11,088) included, 24.3% were women. The mean age (70 years of age) of male and female recipients was similar. Female patients more frequently had an idiopathic cardiomyopathy (67.4% vs. 44.1%) and fewer comorbidities, including atrial fibrillation (34.8% vs. 42.8%), diabetes (29.1% vs. 32.1%), chronic obstructive lung disease (10.3% vs. 12.6%), and renal failure (28.7% vs. 31.9%), compared with men. More women compared with men had a pacemaker (56.6% vs. 46.3%) and much less often an implantable cardioverter-defibrillator (CRT-D) (19.0% vs. 34.7%) implant. Periprocedural event rate was the highest in women with CRT with defibrillator (7.1% vs. 4.8% in men), followed by women with a CRT with pacing (5.5% vs. 4.4% in men). The higher periprocedural event rate in CRT-D women was attributable primarily to the occurrence of pneumothorax (1.4%), coronary sinus dissection (2.1%), and pericardial tamponade (0.3%). The rate of in-hospital major adverse events (6.0%) and complications necessitating reoperation (4.0%) was not different among sex and device type.

    CONCLUSIONS: Women are more likely to experience adverse procedure-related events during CRT implantation. Thus, preventive strategies should be employed to minimize complication rate.

  • 13.
    Baensch, Dietmar
    et al.
    Univ Hosp Rostock, Dept Internal Med 1, Div Cardiol, Heart Ctr Rostock, D-18057 Rostock, Germany..
    Bonnemeier, Hendrik
    Univ Hosp Schleswig Holstein, Dept Internal Med Cardiol & Angiol 3, Kiel, Germany..
    Brandt, Johan
    Skane Univ Hosp, Arrhythmia Dept, Lund, Sweden..
    Bode, Frank
    Univ Hosp Schleswig Holstein, Med Clin Cardiol Angiol & Intens Care Med 2, Lubeck, Germany..
    Svendsen, Jesper Hastrup
    Copenhagen Univ Hosp, Rigshosp, Dept Cardiol, Ctr Heart, Copenhagen, Denmark.;Univ Copenhagen, Danish Arrhythmia Res Ctr, Copenhagen, Denmark..
    Taborsky, Milos
    Fac Hosp Olomouc, Dept Internal Med Cardiol 1, Olomouc, Czech Republic..
    Kuster, Stefan
    DRK Hosp Molln Ratzeburg, Dept Internal Med, Cardiol, Ratzeburg, Germany..
    Blomström-Lundqvist, Carina
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology-Arrhythmia.
    Felk, Angelika
    Biotronik, Berlin, Germany..
    Hauser, Tino
    Biotronik, Berlin, Germany..
    Suling, Anna
    Univ Med Ctr Hamburg Eppendorf, Dept Med Biometry & Epidemiol, Hamburg, Germany..
    Wegscheider, Karl
    Univ Med Ctr Hamburg Eppendorf, Dept Med Biometry & Epidemiol, Hamburg, Germany..
    Intra-operative defibrillation testing and clinical shock efficacy in patients with implantable cardioverter-defibrillators: the NORDIC ICD randomized clinical trial2015In: European Heart Journal, ISSN 0195-668X, E-ISSN 1522-9645, Vol. 36, no 37, p. 2500-2507Article in journal (Refereed)
    Abstract [en]

    Aims This trial was designed to test the hypothesis that shock efficacy during follow-up is not impaired in patients implanted without defibrillation (DF) testing during first implantable cardioverter-defibrillator (ICD) implantation. Methods and results Between February 2011 and July 2013, 1077 patients were randomly assigned (1 : 1) to first time ICD implantation with (n = 540) or without (n = 537) DF testing. The intra-operative DF testing was standardized across all participating centres, and all ICD shocks were programmed to 40 J irrespective of DF test results. The primary end point was the average first shock efficacy (FSE) for all true ventricular tachycardia and fibrillation (VT/VF) episodes during follow-up. The secondary end points included procedural data, serious adverse events, and mortality. During a median follow-up of 22.8 months, the model-based FSE was found to be non-inferior in patients with an ICD implanted without a DF test, with a difference in FSE of 3.0% in favour of the no DF test [confidence interval (CI) -3.0 to 9.0%, Pnon-inferiority <0.001 for the pre-defined non-inferiority margin of 210%). A total of 112 procedure-related serious adverse events occurred within 30 days in 94 patients (17.6%) tested compared with 89 events in 74 patients (13.9%) not tested (P = 0.095). Conclusion Defibrillation efficacy during follow-up is not inferior in patients with a 40 J ICD implanted without DF testing. Defibrillation testing during first time ICD implantation should no longer be recommended for routine left-sided ICD implantation.

  • 14.
    Bagge, Louise
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology-Arrhythmia.
    Surgical ablation for the treatment of atrial fibrillation in different patient populations: A study of clinical outcomes including rhythm, quality of life, atrial function and safety2018Doctoral thesis, comprehensive summary (Other academic)
    Abstract [en]

    Patients with atrial fibrillation (AF) have markedly reduced quality of life (QoL) and catheter ablation has become a useful tool in the rhythm control therapy. However, because of the poor outcome for patients with persistent AF, new surgical ablation strategies for rhythm control are emerging.

    The aims of this thesis were to evaluate QoL, the main indication for rhythm control, after three different types of surgical ablation for AF, two stand-alone epicardial AF ablation procedures and one concomitant procedure during mitral valve surgery (MVS), and to perform a long-term follow-up of one of the techniques with regard to rhythm outcome, left atrial function, exercise capacity and safety.

    As the first center in the Nordic countries to adopt the video-assisted epicardial pulmonary vein isolation and ganglionated plexi ablation combined with left atrial appendage excision (LAA), the  freedom from AF at one year follow-up was found to be 71% and associated with improved exercise capacity, QoL and symptoms as well as preserved left atrial function and size. The most common complication was bleeding events (14%). After 10 years, the improved symptoms and QoL remained, reaching comparable levels of the general Swedish population, despite a marked decline in the rate of freedom from AF (36%). 4 strokes appeared during follow-up despite LAA excision in 3 of these patients.

    In order to improve the rhythm outcome for patients with longstanding persistent AF a box-lesion was added to the procedure. At one year follow-up, both symptoms and QoL improved and was indistinguishable from those in the Swedish general population.

    Finally, concomitant AF ablation during MVS did not improve QoL compared to MVS alone in a double blinded randomized controlled trial. Moreover, no difference was seen between patients in AF or sinus rhythm at one year follow-up, irrespective of the allocated therapy, indicating that their preoperative symptoms were mainly related to their valve disease.

    In conclusion, the stand-alone procedures using surgical ablation was found to be effective but at the expense of procedural complications. In contrast, the concomitant surgical AF ablation did not improve QoL, a finding that raises concerns regarding current recommendations for this procedure. 

    List of papers
    1. Epicardial off-pump pulmonary vein isolation and vagal denervation improve long-term outcome and quality of life in patients with atrial fibrillation
    Open this publication in new window or tab >>Epicardial off-pump pulmonary vein isolation and vagal denervation improve long-term outcome and quality of life in patients with atrial fibrillation
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    2009 (English)In: Journal of Thoracic and Cardiovascular Surgery, ISSN 0022-5223, E-ISSN 1097-685X, Vol. 137, no 5, p. 1265-1271Article in journal (Refereed) Published
    Abstract [en]

    OBJECTIVES: The limited information available on thoracoscopic pulmonary vein isolation combined with ganglionated plexi ablation and the lack of studies regarding its effect on quality of life and physical capacity urged us to study its acute and long-term results in patients with atrial fibrillation. METHODS: Forty-three patients (mean age 57.1 years) with symptomatic atrial fibrillation referred for thoracoscopic off-pump epicardial pulmonary vein isolation and ganglionated plexi ablation using radiofrequency energy were included. RESULTS: The physical capacity improved significantly at 6-month follow-up compared with baseline (mean +/- standard deviation, 165.2 +/- 65 Watt versus 155.9 +/- 57 Watt, P = .02). Quality of life (Short Form-36 health survey) significantly improved 12 months after surgery compared with baseline in all subscales except for bodily pain. The symptom severity questionnaire score decreased significantly from mean 15.2 +/- 4.0 points to 10.7 +/- 4.8 points (P = .02). Overall, 25 of 33 patients (76%) followed up for 12 months had no symptomatic atrial fibrillation recurrences or atrial fibrillation episodes on 24-hour Holter recordings. The corresponding figures were 79% (19/24) for patients with paroxysmal atrial fibrillation, 100% (2/2) for persistent atrial fibrillation, and 57% (4/7) for permanent atrial fibrillation. The most common complication was bleeding events (9%) during pulmonary vein dissection. CONCLUSIONS: Epicardial off-pump pulmonary vein isolation combined with ganglionated plexi ablation improved quality of life, symptoms, and exercise capacity and therefore may be considered for patients with atrial fibrillation who fail endocardial pulmonary vein ablation or as a first-line procedure if left atrial appendage exclusion is warranted.

    National Category
    Medical and Health Sciences
    Identifiers
    urn:nbn:se:uu:diva-103119 (URN)10.1016/j.jtcvs.2008.12.017 (DOI)000265299000034 ()19380002 (PubMedID)
    Available from: 2009-05-14 Created: 2009-05-14 Last updated: 2022-01-28Bibliographically approved
    2. Left atrial function after epicardial pulmonary vein isolation in patients with atrial fibrillation
    Open this publication in new window or tab >>Left atrial function after epicardial pulmonary vein isolation in patients with atrial fibrillation
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    2017 (English)In: Journal of Interventional Cardiac Electrophysiology, ISSN 1383-875X, E-ISSN 1572-8595, Vol. 50, no 2, p. 195-201Article in journal (Refereed) Published
    Keywords
    left atrial function; epicardial; atrial fibrillation; left atrial size; minimally invasive; pulmonary vein isolation; vagal denervation; ganglionated plexi
    National Category
    Cardiac and Cardiovascular Systems
    Research subject
    Cardiology
    Identifiers
    urn:nbn:se:uu:diva-338090 (URN)10.1007/s10840-017-0290-2 (DOI)000416448400007 ()29127542 (PubMedID)
    Funder
    Swedish Research Council, 2014-36708-117759-70Swedish Heart Lung Foundation, 20150751
    Available from: 2018-01-07 Created: 2018-01-07 Last updated: 2022-04-29Bibliographically approved
    3. Quality of life is not improved after mitral valve surgery combined with epicardial left atrial cryoablation as compared with mitral valve surgery alone: a substudy of the double blind randomized SWEDish Multicentre Atrial Fibrillation study (SWEDMAF)
    Open this publication in new window or tab >>Quality of life is not improved after mitral valve surgery combined with epicardial left atrial cryoablation as compared with mitral valve surgery alone: a substudy of the double blind randomized SWEDish Multicentre Atrial Fibrillation study (SWEDMAF)
    Show others...
    2018 (English)In: Europace, ISSN 1099-5129, E-ISSN 1532-2092, Vol. 20, no FI_3, p. f343-f350Article in journal (Refereed) Published
    Abstract [en]

    Aims

    Concomitant surgical ablation of atrial fibrillation (AF) in patients undergoing mitral valve surgery (MVS) has almost become routine despite lack of convincing information about improved quality-of-life (QOL) and clinical benefit. Quality-of-life was therefore assessed after MVS with or without epicardial left atrial cryoablation.

    Methods and results

    Sixty-five patients with permanent AF randomized to MVS with or without left atrial cryoablation, in the double-blinded multicentre SWEDMAF trial, replied to the Short Form 36 QOL survey at 6 and 12 months follow-up. The QOL scores at 12 month follow-up did not differ significantly between patients undergoing MVS combined with cryoablation vs. those undergoing MVS alone regarding Physical Component Summary mean 42.8 (95% confidence interval 38.3–47.3) vs. mean 44.0 (40.1–47.7), P = 0.700 or Mental Component Summary mean 53.1 (49.7–56.4) vs. mean 48.4 (44.6–52.2), P = 0.075. All patients, irrespective of allocated procedure, reached the same QOL after surgery as an age-matched Swedish general population. The Physical Component Summary in patients with sinus rhythm did also not differ from those in AF at 12 months; mean 45.4 (42.0–48.7) vs. mean 40.5 (35.5–45.6), P = 0.096) nor was there a difference in Mental Component Summary; mean 51.0 (48.0–54.1) vs. mean 49.6 (44.6–54.5), P = 0.581).

    Conclusion

    Left atrial cryoablation added to MVS does not improve health-related QOL in patients with permanent AF, a finding that raises concerns regarding recommendations made for this combined procedure.

    Keywords
    concomitant surgical ablation; mitral valve surgery; atrial fibrillation; quality of life; ablation;
    National Category
    Cardiac and Cardiovascular Systems
    Research subject
    Cardiology
    Identifiers
    urn:nbn:se:uu:diva-338091 (URN)10.1093/europace/eux253 (DOI)000454047100014 ()29016835 (PubMedID)
    Funder
    Swedish Heart Lung Foundation, 20150751Swedish Research Council, 2014-36708-117759-70
    Available from: 2018-01-07 Created: 2018-01-07 Last updated: 2020-08-11Bibliographically approved
    4. 10 years follow-up of video-assisted epicardial pulmonary vein isolation and vagal denervation in patients with atrial fibrillation
    Open this publication in new window or tab >>10 years follow-up of video-assisted epicardial pulmonary vein isolation and vagal denervation in patients with atrial fibrillation
    (English)In: Article in journal (Other academic) Submitted
    Keywords
    Atrial fibrillation; epicardial; pulmonary vein isolation; qualiy of life; minimally invasive; vagal denervation; ganglionated plexi
    National Category
    Cardiac and Cardiovascular Systems
    Research subject
    Cardiology
    Identifiers
    urn:nbn:se:uu:diva-338092 (URN)
    Available from: 2018-01-07 Created: 2018-01-07 Last updated: 2018-02-14
    5. A Prospective Study of the Effects of Thoracoscopic Epicardial Left Atrial Ablation on Symptoms and Quality of Life: A comparison with the normal Swedish population and other severe disease states
    Open this publication in new window or tab >>A Prospective Study of the Effects of Thoracoscopic Epicardial Left Atrial Ablation on Symptoms and Quality of Life: A comparison with the normal Swedish population and other severe disease states
    Show others...
    (English)Manuscript (preprint) (Other academic)
    Keywords
    Atrial fibrillation; quality of life; thoracoscopic; epicardial; left atrial ablation;
    National Category
    Cardiac and Cardiovascular Systems
    Research subject
    Cardiology
    Identifiers
    urn:nbn:se:uu:diva-338093 (URN)
    Available from: 2018-01-07 Created: 2018-01-07 Last updated: 2020-08-11
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  • 15.
    Bagge, Louise
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology-Arrhythmia.
    Blomström, Per
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology-Arrhythmia.
    Jidéus, Lena
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Surgical Sciences, Thoracic Surgery.
    Lönnerholm, Stefan
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology-Arrhythmia.
    Blomström-Lundqvist, Carina
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology-Arrhythmia.
    Left atrial function after epicardial pulmonary vein isolation in patients with atrial fibrillation2017In: Journal of Interventional Cardiac Electrophysiology, ISSN 1383-875X, E-ISSN 1572-8595, Vol. 50, no 2, p. 195-201Article in journal (Refereed)
    Download full text (pdf)
    fulltext
  • 16.
    Bagge, Louise
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology-Arrhythmia.
    Blomström-Lundqvist, Carina
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology-Arrhythmia.
    Surgical ablation for atrial fibrillation in mitral valve disease: impact of the maze procedure-authors' response2018In: Europace, ISSN 1099-5129, E-ISSN 1532-2092, Vol. 20, no FI_3, p. f458-f459Article in journal (Refereed)
  • 17.
    Bagge, Louise
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology-Arrhythmia.
    Jansson, Victoria
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology-Arrhythmia.
    Blomström, Per
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology-Arrhythmia.
    Blomström-Lundqvist, Carina
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology-Arrhythmia.
    10 years follow-up of video-assisted epicardial pulmonary vein isolation and vagal denervation in patients with atrial fibrillationIn: Article in journal (Other academic)
  • 18.
    Bagge, Louise
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology-Arrhythmia.
    Probst, Johan
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology-Arrhythmia.
    Blomström, Per
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology-Arrhythmia.
    Thelin, Stefan
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Surgical Sciences, Thoracic Surgery.
    Blomström-Lundqvist, Carina
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology-Arrhythmia.
    Quality of Life Is Not Significantly Improved by Adding Epicardial Left Atrial Cryoablation to Mitral Valve Surgery Than if Performed Alone2017In: Cardiovascular Electrophysiology, ISSN 1045-3873, E-ISSN 1540-8167, Vol. 28, no 5, p. 589-590, article id MA19Article in journal (Other academic)
  • 19.
    Bagge, Louise
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology-Arrhythmia.
    Probst, Johan
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology-Arrhythmia.
    Jensen, Steen M
    Faculty of Medicine, Department of Public Health and Clinical Medicine (Heart centre) Umeå University, SE-901 87 Umeå, Sweden.
    Blomström, Per
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology-Arrhythmia.
    Thelin, Stefan
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Surgical Sciences, Thoracic Surgery.
    Holmgren, Anders
    Faculty of Medicine, Department of Public Health and Clinical Medicine, Cardiology, Umeå University, SE-901 87 Umeå, Sweden.
    Blomström-Lundqvist, Carina
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology-Arrhythmia.
    Quality of life is not improved after mitral valve surgery combined with epicardial left atrial cryoablation as compared with mitral valve surgery alone: a substudy of the double blind randomized SWEDish Multicentre Atrial Fibrillation study (SWEDMAF)2018In: Europace, ISSN 1099-5129, E-ISSN 1532-2092, Vol. 20, no FI_3, p. f343-f350Article in journal (Refereed)
    Abstract [en]

    Aims

    Concomitant surgical ablation of atrial fibrillation (AF) in patients undergoing mitral valve surgery (MVS) has almost become routine despite lack of convincing information about improved quality-of-life (QOL) and clinical benefit. Quality-of-life was therefore assessed after MVS with or without epicardial left atrial cryoablation.

    Methods and results

    Sixty-five patients with permanent AF randomized to MVS with or without left atrial cryoablation, in the double-blinded multicentre SWEDMAF trial, replied to the Short Form 36 QOL survey at 6 and 12 months follow-up. The QOL scores at 12 month follow-up did not differ significantly between patients undergoing MVS combined with cryoablation vs. those undergoing MVS alone regarding Physical Component Summary mean 42.8 (95% confidence interval 38.3–47.3) vs. mean 44.0 (40.1–47.7), P = 0.700 or Mental Component Summary mean 53.1 (49.7–56.4) vs. mean 48.4 (44.6–52.2), P = 0.075. All patients, irrespective of allocated procedure, reached the same QOL after surgery as an age-matched Swedish general population. The Physical Component Summary in patients with sinus rhythm did also not differ from those in AF at 12 months; mean 45.4 (42.0–48.7) vs. mean 40.5 (35.5–45.6), P = 0.096) nor was there a difference in Mental Component Summary; mean 51.0 (48.0–54.1) vs. mean 49.6 (44.6–54.5), P = 0.581).

    Conclusion

    Left atrial cryoablation added to MVS does not improve health-related QOL in patients with permanent AF, a finding that raises concerns regarding recommendations made for this combined procedure.

  • 20. Balabanski, Tosho
    et al.
    Brugada, Josep
    Arbelo, Elena
    Laroche, Cécile
    Maggioni, Aldo
    Blomström-Lundqvist, Carina
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology-Arrhythmia. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology.
    Kautzner, Josef
    Tavazzi, Luigi
    Tritto, Massimo
    Kulakowski, Piotr
    Kalejs, Oskars
    Forster, Tamas
    Villalobos, Federico Segura
    Dagres, Nikolaos
    Impact of monitoring on detection of arrhythmia recurrences in the ESC-EHRA EORP atrial fibrillation ablation long-term registry2019In: Europace, ISSN 1099-5129, E-ISSN 1532-2092, Vol. 21, no 12, p. 1802-1808Article in journal (Refereed)
    Abstract [en]

    AIMS: Monitoring of patients after ablation had wide variations in the ESC-EHRA atrial fibrillation ablation long-term (AFA-LT) registry. We aimed to compare four different monitoring strategies after catheter AF ablation.

    METHODS AND RESULTS: The ESC-EHRA AFA-LT registry included 3593 patients who underwent ablation. Arrhythmia monitoring during follow-up was performed by 12-lead electrocardiogram (ECG), Holter ECG, trans-telephonic ECG monitoring (TTMON), or an implanted cardiac monitoring (ICM) system. Patients were selected to a given monitoring group according to the most extensive ECG tool used in each of them. Comparison of the probability of freedom from recurrences was performed by censored log-rank test and presented by Kaplan-Meier curves. The rhythm monitoring methods were used among 2658 patients: ECG (N = 578), Holter ECG (N = 1874), TTMON (N = 101), and ICM (N = 105). A total of 767 of 2658 patients (28.9%) had AF recurrences during follow-up. Censored log-rank test discovered a lower probability of freedom from relapses, which was detected with ICM compared to TTMON, ECG, and Holter ECG (P < 0.001). The rate of freedom from AF recurrences was 50.5% among patients using the ICM while it was 65.4%, 70.6%, and 72.8% using the TTMON, ECG, and Holter ECG, respectively.

    CONCLUSION: Comparing all main electrocardiographic monitoring methods in a large patient sample, our results suggest that post-ablation recurrences of AF are significantly underreported by TTMON, ECG, and Holter ECG. The ICM estimates AF ablation recurrences most reliably and should be a preferred mode of monitoring for trials evaluating novel AF ablation techniques.

  • 21.
    Baron, Tomasz
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Clinical Physiology.
    Berglund, Lars
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Geriatrics.
    Hedin, Eva-Maria
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology-Arrhythmia.
    Flachskampf, Frank
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Clinical Physiology. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology.
    Test-retest reliability of new and conventional echocardiographic parameters of left ventricular systolic function2019In: Clinical Research in Cardiology, ISSN 1861-0684, E-ISSN 1861-0692, Vol. 108, no 4, p. 355-365Article in journal (Refereed)
    Abstract [en]

    Background: Reliability of left ventricular function measurements depends on actual biological conditions, repeated registrations and their analyses.

    Objective: To investigate test–retest reliability of speckle-tracking-derived strain measurements and its determinants compared to the conventional parameters, such as ejection fraction (EF), LV volumes and mitral annular plane systolic excursion (MAPSE).

    Methods: In 30 patients with a wide range of left ventricular function (mean EF 46.4 ± 16.4%, range 14–73%), standard echo views were acquired independently in a blinded fashion by two different echocardiographers in immediate sequence and analyzed off-line by two independent readers, creating 4 data sets per patient. Test–retest reliability of studied parameters was calculated using the smallest detectable change (SDC) and a total, inter-acquisition and inter-reader intra-class correlation coefficient (ICC).

    Results: The smallest detectable change normalized to the mean absolute value of the measured parameter (SDCrel) was lowest for MAPSE (10.7%). SDCrel for EF was similar to GLS (14.2 and 14.7%, respectively), while SDCrel for CS was much higher (35.6%). The intra-class correlation coefficient was excellent (> 0.9) for all measures of the left ventricular function. Intra-patient inter-acquisition reliability (ICCacq) was significantly better than inter-reader reliability (ICCread) (0.984 vs. 0.950, p = 0.03) only for EF, while no significant difference was observed for any other LV function parameter. Mean intra-subject standard deviations were significantly correlated to the mean values for CS and LV volumes, but not for the other studied parameters.

    Conclusions: In a test–retest setting, both with normal and impaired left ventricular function, the smallest relative detectable change of EF, GLS and MAPSE was similar (11–15%), but was much higher for CS (35%). Surprisingly, reliability of GLS was not superior to that of EF. Acquisition and reader to a similar extent influenced the reliability of measurements of all left ventricular function measures except for ejection fraction, where the reliability was more dependent on the reader than on the acquisition.

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  • 22.
    Baron, Tomasz
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology.
    Christersson, Christina
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology.
    Hjorthén, Gustav
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences.
    Hedin, Eva-Maria
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology-Arrhythmia.
    Flachskampf, Frank
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology.
    Changes in global longitudinal strain and left ventricular ejection fraction during the first year after myocardial infarction: results from a large consecutive cohort2018In: European Heart Journal Cardiovascular Imaging, ISSN 2047-2404, E-ISSN 2047-2412, Vol. 19, no 10, p. 1165-1173Article in journal (Refereed)
    Abstract [en]

    Aims: To determine changes of global longitudinal strain (GLS) and their predictors in relation to classical echocardiographic parameters of left ventricular (LV) function, over 1 year, in consecutive patients with myocardial infarction (MI) and initially normal or impaired LV ejection fraction (EF).

    Methods and results: A total of 285 patients with MI prospectively included in the REBUS (RElevance of Biomarkers for future risk of thromb-oembolic events in UnSelected post-myocardial infarction patients) study underwent echocardiography within 72 h from admission and after 1 year. At baseline, 213 (74.7%) of MI patients had a normal EF (≥52% in men or ≥54% in women), but in 70.4% of them, an impaired GLS ( ≥ -18.0%) was observed. During 1-year follow-up, in patients with normal EF at baseline, GLS improved from -15.8% to - 17.4% (10.1% relative change); EF decreased from 62.5% to 59.9% (4.0% relative change); indexed end-diastolic volume, indexed end-systolic volume, and indexed stroke volume increased with 15.6%, 24.8%, and 10.0% of relative change, respectively (P < 0.001 for all the comparisons). In the whole cohort, initial impairment of LV function [by EF, wall motion score index (WMSI), or GLS], male gender, non-smoking, and treatment with beta-blockers were the independent predictors of GLS improvement. In the group with initially impaired EF, over 1 year GLS improved from -11.9% to - 14.8% (24.4% relative change) and EF from 44.6% to 52.6% (18.2% relative change) (P < 0.001 for both). Improvement in GLS significantly correlated with EF increase in the group with impaired EF (r = -0.41, P = 0.001) but not in the patients with normal EF (r = -0.14, P = ns).

    Conclusions: Despite diveregent evolution of GLS compared with EF and ventricular volumes, one year after MI GLS significantly improved in patients with initially both normal and impaired EF. Initial impairment of LV function (by EF, WMSI, or GLS), male gender, non-smoking, and treatment with beta-blockers were independent predictors of GLS improvement. LV remodelling was present even in patients with normal EF at baseline and during follow-up, confirming limited functional assessment by EF alone.

  • 23.
    Baron, Tomasz
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology.
    Flachskampf, Frank A
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology.
    Johansson, Kristina
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences.
    Hedin, Eva-Maria
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology-Arrhythmia.
    Christersson, Christina
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology.
    Usefulness of traditional echocardiographic parameters in assessment of left ventricular function in patients with normal ejection fraction early after acute myocardial infarction: results from a large consecutive cohort2016In: European Heart Journal Cardiovascular Imaging, ISSN 2047-2404, E-ISSN 2047-2412, Vol. 17, no 4, p. 413-420Article in journal (Refereed)
    Abstract [en]

    AIMS: The aim of this study was to assess the frequency of left ventricular (LV) systolic function impairment using classical echocardiographic parameters and their relation to myocardial damage in patients hospitalized for acute myocardial infarction (MI) with normal LV ejection fraction (LVEF ≥52% in males or ≥54% in females).

    METHODS AND RESULTS: All 421 consecutive patients with MI included in the REBUS (RElevance of Biomarkers for future risk of thromboembolic events in UnSelected post-myocardial infarction patients) study underwent two-dimensional and Doppler echocardiography within 72 h after admission. A normal LVEF was present in 262 (73.8%) of the 355 patients ultimately enrolled in the study. Patients with normal LVEF more often presented with non-ST-elevation myocardial infarction and had less comorbidities when compared with those with impaired LVEF. No differences in demographic factors or relevant medications were observed. Higher value of mean annular plane systolic excursion (MAPSE), lower wall motion score index (WMSI), lower LV as well as left atrial volumes characterized patients with normal LVEF. Impaired MAPSE was present in 64.4%, WMSI >1 in 72.1%, and dilated left atrium in 33.6% of those patients. Maximal cardiac troponin concentration reflecting infarct size showed the strongest association with WMSI (β = 0.35), followed by LVEF (β = -0.29), MAPSE (β = -0.25), and indexed LV end-systolic volume (β = 0.19; P < 0.001 for all the models).

    CONCLUSION: In two-third of patients with MI and normal LVEF, at least one of the other markers of systolic function was outside of the normal range. WMSI reflected the size of MI better than global LV function parameters as LVEF or MAPSE.

  • 24.
    Baron, Tomasz
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Clinical Physiology.
    Örndahl, Lovisa Holm
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Clinical Physiology.
    Kero, Tanja
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Surgical Sciences, Radiology.
    Sörensen, Jens
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Surgical Sciences, Radiology.
    Bjerner, Tomas
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Surgical Sciences, Radiology.
    Hedin, Eva-Maria
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology-Arrhythmia. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Clinical Physiology.
    Ståhle, Elisabeth
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Surgical Sciences, Thoracic Surgery.
    Flachskampf, Frank A.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center.
    Comparison of left ventricular volumes and regurgitant volumes by echocardiography and magnetic resonance in patients with severe degenerative mitral regurgitation2016In: European Heart Journal, ISSN 0195-668X, E-ISSN 1522-9645, Vol. 37, p. 1239-1239Article in journal (Refereed)
  • 25. Bertaglia, Emanuele
    et al.
    Blank, Benjamin
    Blomström-Lundqvist, Carina
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology-Arrhythmia.
    Brandes, Axel
    Cabanelas, Nuno
    Dan, G-Andrei
    Dichtl, Wolfgang
    Goette, Andreas
    de Groot, Joris R
    Lubinski, Andrzej
    Marijon, Eloi
    Merkely, Béla
    Mont, Lluis
    Piorkowski, Christopher
    Sarkozy, Andrea
    Sulke, Neil
    Vardas, Panos
    Velchev, Vasil
    Wichterle, Dan
    Kirchhof, Paulus
    Atrial high-rate episodes: prevalence, stroke risk, implications for management, and clinical gaps in evidence2019In: Europace, ISSN 1099-5129, E-ISSN 1532-2092, Vol. 21, no 10, p. 1459-1467Article, review/survey (Refereed)
    Abstract [en]

    Self-terminating atrial arrhythmias are commonly detected on continuous rhythm monitoring, e.g. by pacemakers or defibrillators. It is unclear whether the presence of these arrhythmias has therapeutic consequences. We sought to summarize evidence on the prevalence of atrial high-rate episodes (AHREs) and their impact on risk of stroke. We performed a comprehensive, tabulated review of published literature on the prevalence of AHRE. In patients with AHRE, but without atrial fibrillation (AF), we reviewed the stroke risk and the potential risk/benefit of oral anticoagulation. Atrial high-rate episodes are found in 10-30% of AF-free patients. Presence of AHRE slightly increases stroke risk (0.8% to 1%/year) compared with patients without AHRE. Atrial high-rate episode of longer duration (e.g. those >24 h) could be associated with a higher stroke risk. Oral anticoagulation has the potential to reduce stroke risk in patients with AHRE but is associated with a rate of major bleeding of 2%/year. Oral anticoagulation is not effective in patients with heart failure or survivors of a stroke without AF. It remains unclear whether anticoagulation is effective and safe in patients with AHRE. Atrial high-rate episodes are common and confer a slight increase in stroke risk. There is true equipoise on the best way to reduce stroke risk in patients with AHRE. Two ongoing trials (NOAH-AFNET 6 and ARTESiA) will provide much-needed information on the effectiveness and safety of oral anticoagulation using non-vitamin K antagonist oral anticoagulants in patients with AHRE.

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  • 26. Bianchi, Stefano
    et al.
    Rossi, Pietro
    Schauerte, Patrick
    Elvan, Arif
    Blomström Lundqvist, Carina
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology-Arrhythmia.
    Kornet, Lilian
    Gal, Pim
    Mörtsell, David
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology-Arrhythmia.
    Wouters, Griet
    Gemein, Christopher
    Increase of Ventricular Interval During Atrial Fibrillation by Atrioventricular Node Vagal Stimulation: Chronic Clinical Atrioventricular-Nodal Stimulation Download Study2015In: Circulation: Arrhythmia and Electrophysiology, ISSN 1941-3149, E-ISSN 1941-3084, Vol. 8, no 3, p. 562-568Article in journal (Refereed)
    Abstract [en]

    BACKGROUND: -Patients with a high ventricular rate during atrial fibrillation (AF) are at increased risk of receiving inappropriate implantable cardioverter defibrillator (ICD) shocks. The objective was to demonstrate the feasibility of high frequency atrioventricular-nodal stimulation (AVNS) to reduce the ventricular rate during AF to prevent inappropriate ICD shocks.

    METHODS AND RESULTS: -Patients with a new atrial lead placement as part of a CRT-D implant and a history of paroxysmal or persistent AF were eligible. If proper atrial lead position was confirmed, AVNS software was uploaded to the CRT device, tested and optimized. AVNS was delivered via a right atrial pacing lead positioned in the posterior right atrium. Software allowed initiation of high frequency bursts triggered on rapidly conducted AF. Importantly, the efficacy was evaluated during spontaneous AF episodes between 1 and 6 months after implant. Forty-four patients were enrolled in 4 centers. Successful atrial lead placement occurred in 74%. Median implant time of the AVNS lead was 37 minutes. In 26 (81%) patients, manual AVNS tests increased the ventricular interval by > 25%. Between 1 and 6 months, automatic AVNS activations occurred in 4 patients with rapidly conducted AF, and in 3 patients, AVNS slowed the ventricular rate out of the ICD shock zone. No adverse events were associated with the AVNS software.

    CONCLUSIONS: -The present study demonstrated the feasibility of implementation of AVNS in a CRT-D system. AVNS increased ventricular interval > 25% in 81% of patients. AVNS did not influence the safety profile of the CRT-D system.

  • 27.
    Blomström Lundqvist, Carina
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology-Arrhythmia.
    Auricchio, Angelo
    Brugada, Josep
    Boriani, Giuseppe
    Bremerich, Jens
    Cabrera, Jose Angel
    Frank, Herbert
    Gutberlet, Matthias
    Heidbuchel, Hein
    Kuck, Karl-Heinz
    Lancellotti, Patrizio
    Rademakers, Frank
    Winkels, Gerard
    Wolpert, Christian
    Vardas, Panos E
    The use of imaging for electrophysiological and devices procedures: a report from the first European Heart Rhythm Association Policy Conference, jointly organized with the European Association of Cardiovascular Imaging (EACVI), the Council of Cardiovascular Imaging and the European Society of Cardiac Radiology2013In: Europace, ISSN 1099-5129, E-ISSN 1532-2092, Vol. 15, no 7, p. 927-936Article in journal (Refereed)
    Abstract [en]

    Implantations of cardiac devices therapies and ablation procedures frequently depend on accurate and reliable imaging modalities for pre-procedural assessments, intra-procedural guidance, detection of complications, and the follow-up of patients. An understanding of echocardiography, cardiovascular magnetic resonance imaging, nuclear cardiology, X-ray computed tomography, positron emission tomography, and vascular ultrasound is indispensable for cardiologists, electrophysiologists as well as radiologists, and it is currently recommended that physicians should be trained in several imaging modalities. There are, however, no current guidelines or recommendations by electrophysiologists, cardiac imaging specialists, and radiologists, on the appropriate use of cardiovascular imaging for selected patient indications, which needs to be addressed. A Policy Conference on the use of imaging in electrophysiology and device management, with representatives from different expert areas of radiology and electrophysiology and commercial developers of imaging and device technologies, was therefore jointly organized by European Heart Rhythm Association (EHRA), the Council of Cardiovascular Imaging and the European Society of Cardiac Radiology (ESCR). The objectives were to assess the state of the level of evidence and a first step towards a consensus document for currently employed imaging techniques to guide future clinical use, to elucidate the issue of reimbursement structures and health economy, and finally to define the need for appropriate educational programmes to ensure clinical competence for electrophysiologists, imaging specialists, and radiologists.

  • 28.
    Blomström-Lundqvist, Carina
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology-Arrhythmia.
    Atrial fibrillation: from atrial extrasystoles to atrial cardiomyopathy - what have we learned from basic science and interventional procedures?2016In: Journal of Internal Medicine, ISSN 0954-6820, E-ISSN 1365-2796, Vol. 279, no 5, p. 406-411Article in journal (Other academic)
  • 29.
    Blomström-Lundqvist, Carina
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology-Arrhythmia.
    CABANA Trial, another favourable view2018In: European Heart Journal, ISSN 0195-668X, E-ISSN 1522-9645, Vol. 39, no 30, p. 2771-2772Article in journal (Other academic)
  • 30.
    Blomström-Lundqvist, Carina
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology-Arrhythmia. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology.
    Effects of COVID-19 lockdown strategies on management of atrial fibrillation2020In: European Heart Journal, ISSN 0195-668X, E-ISSN 1522-9645, Vol. 41, no 32, p. 3080-3082Article in journal (Refereed)
  • 31.
    Blomström-Lundqvist, Carina
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology-Arrhythmia.
    Blomström, Per
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology-Arrhythmia.
    Safety and efficacy of pharmacological cardioversion of atrial fibrillation using intravenous vernakalant, a new antiarrhythmic drug with atrial selectivity2012In: Expert Opinion on Drug Safety, ISSN 1474-0338, E-ISSN 1744-764X, Vol. 11, no 4, p. 671-679Article in journal (Refereed)
    Abstract [en]

    Introduction:

    Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia that due to its frequent hospitalizations and increased complication rates imposes a significant health economic burden. Many patients with recurrent AF are admitted to the hospital for cardioversion to restore sinus rhythm. Given this knowledge, it is clearly important to identify a feasible and effective approach for cardioversion of these patients. Cardioversion always requires careful assessment of potential complications, which apart from thromboembolic risks, include proarrhythmias and those related to the deep sedation required for electrical cardioversion. Even though electrical cardioversion is proven to be safe and effective, the need for anesthesia makes alternative strategies more attractive.

    Areas covered:

    The research discussed is the alternative strategies for cardioversion, including electrical cardioversion and the new relatively atrial-selective antiarrhythmic drug, vernakalant. The literature search methodology undertaken included search in PubMed (cardioversion, vernakalant, conversion as key words).

    Expert opinion:

    Vernakalant is shown to have good conversion rates, an apparently safe antiarrhythmic profile and is well tolerated in patients with a history of ischemic heart disease. In most cases of recent-onset AF, pharmacological cardioversion can provide a probably more cost-effective and safer alternative to electrical cardioversion, which can then be used as a second option for those who failed the first attempt of cardioversion.

  • 32.
    Blomström-Lundqvist, Carina
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology-Arrhythmia.
    Gizurarson, Sigfus
    Univ Gothenburg, Sahlgrenska Acad, Dept Mol & Clin Med Cardiol, Inst Med, Gothenburg, Sweden;Sahlgrens Univ Hosp, Dept Cardiol, Gothenburg, Sweden.
    Schwieler, Jonas
    Karolinska Univ Hosp, Heart & Vasc Theme, Stockholm, Sweden.
    Jensen, Steen M
    Umea Univ, Ctr Heart, Umea, Sweden;Umea Univ, Dept Publ Hlth & Clin Med, Umea, Sweden.
    Bergfeldt, Lennart
    Univ Gothenburg, Sahlgrenska Acad, Dept Mol & Clin Med Cardiol, Inst Med, Gothenburg, Sweden;Sahlgrens Univ Hosp, Dept Cardiol, Gothenburg, Sweden.
    Kennebäck, Göran
    Karolinska Univ Hosp, Heart & Vasc Theme, Stockholm, Sweden.
    Rubulis, Aigars
    Univ Gothenburg, Sahlgrenska Acad, Dept Mol & Clin Med Cardiol, Inst Med, Gothenburg, Sweden;Sahlgrens Univ Hosp, Dept Cardiol, Gothenburg, Sweden.
    Malmborg, Helena
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology-Arrhythmia.
    Raatikainen, Pekka
    Tampere Univ Hosp, Dept Cardiol, Ctr Heart, Tampere, Finland.
    Lönnerholm, Stefan
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology-Arrhythmia.
    Höglund, Niklas
    Umea Univ, Ctr Heart, Umea, Sweden;Umea Univ, Dept Publ Hlth & Clin Med, Umea, Sweden.
    Mörtsell, David
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology-Arrhythmia.
    Effect of Catheter Ablation vs Antiarrhythmic Medication on Quality of Life in Patients With Atrial Fibrillation: The CAPTAF Randomized Clinical Trial2019In: JAMIA Journal of the American Medical Informatics Association, ISSN 1067-5027, E-ISSN 1527-974X, Vol. 321, no 11, p. 1059-1068Article in journal (Refereed)
    Abstract [en]

    IMPORTANCE Quality of life is not a standard primary outcome in ablation trials, even though symptoms drive the indication. OBJECTIVE To assess quality of life with catheter ablation vs antiarrhythmic medication at 12 months in patients with atrial fibrillation. DESIGN, SETTING, AND PARTICIPANTS Randomized clinical trial at 4 university hospitals in Sweden and 1 in Finland of 155 patients aged 30-70 years with more than 6 months of atrial fibrillation and treatment failure with 1 antiarrhythmic drug or beta-blocker, with 4-year follow-up. Study dateswere July 2008-September 2017. Major exclusionswere ejection fraction <35%, left atrial diameter > 60 mm, ventricular pacing dependency, and previous ablation. INTERVENTIONS Pulmonary vein isolation ablation (n= 79) or previously untested antiarrhythmic drugs (n= 76). MAIN OUTCOMES AND MEASURES Primary outcomewas the General Health subscale score (Medical Outcomes Study 36-Item Short-Form Health Survey) at baseline and 12 months, assessed unblinded (range, 0 [worst] to 100 [best]). There were 26 secondary outcomes, including atrial fibrillation burden (% of time) from baseline to 12 months, measured by implantable cardiac monitors. The first 3 months were excluded from rhythm analysis. RESULTS Among 155 randomized patients (mean age, 56.1 years; 22.6% women), 97% completed the trial. Of 79 patients randomized to receive ablation, 75 underwent ablation, including 2 who crossed over to medication and 14 who underwent repeated ablation procedures. Of 76 patients randomized to receive antiarrhythmic medication, 74 received it, including 8 who crossed over to ablation and 43 for whom the first drug used failed. General Health score increased from 61.8 to 73.9 points in the ablation group vs 62.7 to 65.4 points in the medication group (between-group difference, 8.9 points; 95% CI, 3.1-14.7; P=.003). Of 26 secondary end points, 5 were analyzed; 2 were null and 2 were statistically significant, including decrease in atrial fibrillation burden (from 24.9% to 5.5% in the ablation group vs 23.3% to 11.5% in the medication group; difference -6.8%[95% CI, -12.9% to -0.7%]; P=.03). Of the Health Survey subscales, 5 of 7 improved significantly. Most common adverse events were urosepsis (5.1%) in the ablation group and atrial tachycardia (3.9%) in the medication group. CONCLUSIONS AND RELEVANCE Among patients with symptomatic atrial fibrillation despite use of antiarrhythmic medication, the improvement in quality of life at 12 months was greater for those treated with catheter ablation compared with antiarrhythmic medication. Although the study was limited by absence of blinding, catheter ablation may offer an advantage for quality of life.

  • 33.
    Blomström-Lundqvist, Carina
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology-Arrhythmia. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology.
    Marrouche, Nassir
    Connolly, Stuart
    Corp Dit Genti, Valérie
    Wieloch, Mattias
    Koren, Andrew
    Hohnloser, Stefan H
    Efficacy and safety of dronedarone by atrial fibrillation history duration: Insights from the ATHENA study.2020In: Clinical Cardiology, ISSN 0160-9289, E-ISSN 1932-8737, Vol. 43, no 12, p. 1469-1477Article in journal (Refereed)
    Abstract [en]

    BACKGROUND: Atrial fibrillation/atrial flutter (AF/AFL) burden increases with increasing duration of AF/AFL history.

    HYPOTHESIS: Outcomes with dronedarone may also be impacted by duration of AF/AFL history.

    METHODS: In this post hoc analysis of ATHENA, efficacy and safety of dronedarone vs placebo were assessed in groups categorized by time from first known AF/AFL episode to randomization (ie, duration of AF/AFL history): <3 months (short), 3 to <24 months (intermediate), and ≥ 24 months (long).

    RESULTS: Of 2859 patients with data on duration of AF/AFL history, 45.3%, 29.6%, and 25.1% had short, intermediate, and long histories, respectively. Patients in the long history group had the highest prevalence of structural heart disease and were more likely to be in AF/AFL at baseline. Placebo-treated patients in the long history group also had the highest incidence of AF/AFL recurrence and cardiovascular (CV) hospitalization during the study. The risk of first CV hospitalization/death from any cause was lower with dronedarone vs placebo in patients with short (hazard ratio, 0.79 [95% confidence interval: 0.65-0.96]) and intermediate (0.72 [0.56-0.92]) histories; a trend favoring dronedarone was also observed in patients with long history (0.84 [0.66-1.07]). A similar pattern was observed for first AF/AFL recurrence. No new drug-related safety issues were identified.

    CONCLUSIONS: Patients with long AF/AFL history had the highest burden of AF/AFL at baseline and during the study. Dronedarone significantly improved efficacy vs placebo in patients with short and intermediate AF/AFL histories. While exploratory, these results support the potential value in initiating rhythm control treatment early in patients with AF/AFL.

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  • 34.
    Blomström-Lundqvist, Carina
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology-Arrhythmia. Örebro Univ, Fac Med & Hlth, Sch Med Sci, Dept Cardiol, SE-70182 Örebro, Sweden..
    Naccarelli, Gerald, V
    Penn State Univ Coll Med, Penn State Hershey Heart & Vasc Inst, 500 Univ Dr, Hershey, PA 17033 USA..
    McKindley, David S.
    Sanofi, 55 Corp Dr, Bridgewater, NJ 08807 USA..
    Bigot, Gregory
    IVIDATA Life Sci, 79 Rue Baudin, F-92300 Paris, Levallois Perre, France..
    Wieloch, Mattias
    Sanofi, Rue Boetie 54-56, F-75008 Paris, France.;Lund Univ, Dept Coagulat Disorders, Jan Waldenstroms Gata 14, S-20502 Lund, Sweden..
    Hohnloser, Stefan H.
    Goethe Univ Frankfurt, Dept Cardiol, Div Clin Electrophysiol, Theodor Stern Kai 7, D-60590 Frankfurt, Germany..
    Effect of dronedarone vs. placebo on atrial fibrillation progression: a post hoc analysis from ATHENA trial2023In: Europace, ISSN 1099-5129, E-ISSN 1532-2092, Vol. 25, no 3, p. 845-854Article in journal (Refereed)
    Abstract [en]

    Aims: This post hoc analysis of the ATHENA trial (NCT00174785) assessed the effect of dronedarone on the estimated burden of atrial fibrillation (AF)/atrial flutter (AFL) progression to presumed permanent AF/AFL, and regression to sinus rhythm (SR), compared with placebo.

    Methods and results: The burden of AF/AFL was estimated by a modified Rosendaal method using available electrocardiograms (ECG). Cumulative incidence of permanent AF/AFL (defined as >= 6 months of AF/AFL until end of study) or permanent SR (defined as >= 6 months of SR until end of study) were calculated using Kaplan-Meier estimates. A log-rank test was used to assess statistical significance. Hazard ratios (HRs) with corresponding 95% confidence intervals (CIs) were estimated using a Cox model, adjusted for treatment group. Of the 4439 patients included in this analysis, 2208 received dronedarone, and 2231 placebo. Baseline and clinical characteristics were well balanced between groups. Overall, 304 (13.8%) dronedarone-treated patients progressed to permanent AF/AFL compared with 455 (20.4%) treated with placebo (P < 0.0001). Compared with those receiving placebo, patients receiving dronedarone had a lower cumulative incidence of permanent AF/AFL (log-rank P < 0.001; HR: 0.65; 95% CI: 0.56-0.75), a higher cumulative incidence of permanent SR (log-rank P < 0.001; HR: 1.19; 95% CI: 1.09-1.29), and a lower estimated AF/AFL burden over time (P < 0.01 from Day 14 to Month 21).

    Conclusion: These results suggest that dronedarone could be a useful antiarrhythmic drug for early rhythm control due to less AF/AFL progression and more regression to SR vs. placebo, potentially reflecting reverse remodeling.

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  • 35.
    Blomström-Lundqvist, Carina
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology-Arrhythmia.
    Ostrowska, Bozena
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology-Arrhythmia.
    Prevention of cardiac implantable electronic device infections: guidelines and conventional prophylaxis2021In: Europace, ISSN 1099-5129, E-ISSN 1532-2092, Vol. 23, no Supplement 4, p. iv11-iv19Article in journal (Refereed)
    Abstract [en]

    Cardiac implantable electronic devices (CIED) are potentially life-saving treatments for several cardiac conditions, but are not without risk. Despite dissemination of recommended strategies for prevention of device infections, such as administration of antibiotics before implantation, infection rates continue to rise resulting in escalating health care costs. New trials conveying important steps for better prevention of device infection and an EHRA consensus paper were recently published. This document will review the role of various preventive measures for CIED infection, emphasizing the importance of adhering to published recommendations. The document aims to provide guidance on how to prevent CIED infections in clinical practice by considering modifiable and non-modifiable risk factors that may be present pre-, peri-, and/or post-procedure.

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  • 36.
    Blomström-Lundqvist, Carina
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology-Arrhythmia. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology.
    Potpara, Tatjana S
    Univ Belgrade, Sch Med, Belgrade, Serbia.
    Malmborg, Helena
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology-Arrhythmia.
    Supraventricular Arrhythmias in Patients with Adult Congenital Heart Disease.2017In: Arrhythmia & electrophysiology review, ISSN 2050-3369, Vol. 6, no 2, p. 42-49Article in journal (Refereed)
    Abstract [en]

    An increasing number of patients with congenital heart disease survive to adulthood; such prolonged survival is related to a rapid evolution of successful surgical repairs and modern diagnostic techniques. Despite these improvements, corrective atrial incisions performed at surgery still lead to subsequent myocardial scarring harbouring a potential substrate for macro-reentrant atrial tachycardia. Macroreentrant atrial tachycardias are the most common (75 %) type of supraventricular tachycardia (SVT) in patients with adult congenital heart disease (ACHD). Patients with ACHD, atrial tachycardias and impaired ventricular function - important risk factors for sudden cardiac death (SCD) - have a 2-9 % SCD risk per decade. Moreover, ACHD imposes certain considerations when choosing antiarrhythmic drugs from a safety aspect and also when considering catheter ablation procedures related to the inherent cardiac anatomical barriers and required expertise. Expert recommendations for physicians managing these patients are therefore mandatory. This review summarises current evidence-based developments in the field, focusing on advances in and general recommendations for the management of ACHD, including the recently published recommendations on management of SVT by the European Heart Rhythm Association.

  • 37.
    Blomström-Lundqvist, Carina
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology-Arrhythmia.
    Pürerfellner, Helmut
    Elisabethinen Hosp, Linz, Austria..
    White, Alex
    Expert Patient, London, England..
    Schilling, Richard
    Barts Hlth NHS Trust, London, England..
    Redefining the Standard for Atrial Fibrillation: A Patient-centric Report2021In: ARRHYTHMIA & ELECTROPHYSIOLOGY REVIEW, ISSN 2050-3369, Vol. 10, no Suppl. 1, p. 1-6Article in journal (Other academic)
    Abstract [en]

    A roundtable discussion with three European clinical experts in AF and one expert patient diagnosed and treated for AF was conducted in London in October 2019. The panel discussed the implications of AF for patients, current patient pathways, what treatment outcomes were relevant for patients and how the recommendations for the management of AF may change in the future, based on the outcomes of recently published and on-going clinical trials. This article summarises the discussion, and draws upon wider sources to detail best practice and optimal patient treatment pathways.

  • 38.
    Blomström-Lundqvist, Carina
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology-Arrhythmia.
    Svedung Wettervik, Victoria
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology-Arrhythmia.
    Reflections on the usefulness of today’s atrial fibrillation ablation procedure endpoints and patient-reported outcomes2022In: Europace, ISSN 1099-5129, E-ISSN 1532-2092, Vol. 24, no Supplement_2, p. ii29-ii43Article in journal (Refereed)
    Abstract [en]

    The improvement of Patient-reported outcomes, such as health-related quality of life, is the main indication for atrial fibrillation ablation. Despite this guideline derived indication for an AF ablation procedure the current standardized primary endpoint in AF ablation trials is still rhythm-related, and primarily a 30-second long AF episode. The review presents reflections on the non-rational arguments of using rhythm related endpoints rather than Patient-reported outcomes in AF ablation procedure trials despite the mismatch between many of the rhythm related variables and symptoms. Arguments for health-related quality of life as the most optimal primary endpoint in clinical trials are presented while atrial fibrillation burden is presented as the most optimal electrical complementary endpoint, apart from being the major variable in mechanistic trials.

  • 39. Bongiorni, Maria G
    et al.
    Burri, Haran
    Deharo, Jean C.
    Starck, Christoph
    Kennergren, Charles
    Saghy, Laszlo
    Rao, Archana
    Tascini, Carlo
    Lever, Nigel
    Kutarski, Andrzej
    Fernandez Lozano, Ignacio
    Strathmore, Neil
    Costa, Roberto
    Epstein, Laurence
    Love, Charles
    Blomström-Lundqvist, Carina
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology-Arrhythmia.
    Fauchier, Laurent
    Defaye, Pascal
    Arnar, David O.
    Klug, Didier
    Boveda, Serge
    Cosedis Nielsen, Jens
    Boriani, Giuseppe
    Zhang, Shu
    Martin, Andrew Paul
    Prutkin, Jordan M.
    de Zuloaga, Claudio
    2018 EHRA expert consensus statement on lead extraction: recommendations on definitions, endpoints, research trial design, and data collection requirements for clinical scientific studies and registries: endorsed by APHRS/HRS/LAHRS2018In: Europace, ISSN 1099-5129, E-ISSN 1532-2092, Vol. 20, no 7, article id 1217Article in journal (Refereed)
    Abstract [en]

    The number of cardiac implantable electronic device (CIED) implantations has increased over recent years as a result of population growth, increasing life expectancy, adoption of guidelines, and better access to healthcare. Transvenous lead extraction (TLE), as a part of an overall lead management strategy, has also been increasing, not only as a consequence of this growth, but also because of increasing rates of infection, lead failure, awareness of indications for lead management, and development of extraction tools. Clinical research is essential for understanding efficacy and risks of TLE, which has important implications regarding decision-making and therapeutic strategies in patients who are candidates for this procedure. Data on TLE have mainly come from retrospective series, with variable reporting of endpoints. Recently, the ELECTRa registry conducted by the European Heart Rhythm Association (EHRA), has reported the largest prospective experience on lead extraction published to date in 3555 patients recruited from 19 European countries. There remain unresolved issues, which is a strong incentive for conducting further specifically-designed clinical trials to answer important questions in this area. In addition to clinical studies, national registries are potentially useful for evaluating epidemiology of TLE as well as for quality control and understanding resource implications. Standardization of definitions and reporting of parameters are paramount in order to analyse, compare, and pool data for scientific purposes. Expert consensus statements on lead extraction have been published by the Heart Rhythm Society (HRS) in 2009 and 2017, and by EHRA in 2012. Experience from the ELECTRa registry has been valuable for identifying challenges faced with conducting scientific studies in this field, and provides a framework for future endeavours.

    This writing group has been commissioned by EHRA to provide recommendations for designing scientific studies, reports and registries relating to lead extraction.

  • 40. Bongiorni, Maria Grazia
    et al.
    Chen, Jian
    Dagres, Nikolaos
    Estner, Heidi
    Hernandez-Madrid, Antonio
    Hocini, Meleze
    Larsen, Torben Bjerregaard
    Pison, Laurent
    Potpara, Tatjana
    Proclemer, Alessandro
    Sciaraffia, Elena
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology-Arrhythmia.
    Todd, Derick
    Blomström-Lundqvist, Carina
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology-Arrhythmia.
    EHRA research network surveys: 6 years of EP wires activity2015In: Europace, ISSN 1099-5129, E-ISSN 1532-2092, Vol. 17, no 11Article in journal (Refereed)
    Abstract [en]

    Clinical practice should follow guidelines and recommendations mainly based on the results of controlled trials, which are often conducted in selected populations and special conditions, whereas clinical practice may be influenced by factors different from controlled scientific studies. Hence, the real-world setting is better assessed by the observational registries enrolling patients for longer periods of time. However, this may be difficult, expensive, and time-consuming. In 2009, the Scientific Initiatives Committee of the European Heart Rhythm Association (EHRA) has instigated a series of surveys covering the controversial issues in clinical electrophysiology (EP). With this in mind, an EHRA EP research network has been created, which included EP centres in Europe among which the surveys on 'hot topic' were circulated. This review summarizes the overall experience conducting EP wires over the past 6 years, categorizing and assessing the topics regarding clinical EP, and evaluating the acceptance and feedback from the responding centres, in order to improve participation in the surveys and better address the research needs and aspirations of the European EP community.

  • 41.
    Bongiorni, Maria Grazia
    et al.
    Univ Hosp Pisa, Dept Cardiol, Via Paradisa 2, I-56124 Pisa, Italy..
    Kennergren, Charles
    Sahlgrens Univ Hosp, Dept Cardiothorac Surg, S-41345 Gothenburg, Sweden..
    Butter, Christian
    Heart Ctr Brandenburg Bernau, Dept Cardiol, Ladeburger Str 17m, D-16321 Bernau, Germany.;Med Sch Brandenburg, Ladeburger Str 17m, D-16321 Bernau, Germany..
    Deharo, Jean Claude
    CHU La Timone, La Timone Univ Hosp, Arrhythmias Unit, Dept Cardiol, 265 Rue St Pierre, F-13005 Marseille, France..
    Kutarski, Andrzej
    Med Univ Lublin, Dept Cardiol, Ul Jaczewskiego 8, PL-20954 Lublin, Poland..
    Rinaldi, Christopher A.
    Guys & St Thomas Hosp, Cardiol Dept, 6th Floor East Wing,Westminster Bridge Rd, London SE1 7EH, England..
    Romano, Simone L.
    Univ Hosp Pisa, Dept Cardiol, Via Paradisa 2, I-56124 Pisa, Italy..
    Maggioni, Aldo P.
    European Soc Cardiol, European Heart House,2035 Route Colles, F-06903 Sophia Antipolis, France.;ANMCO Res Ctr, Via La Marmora 34, I-50121 Florence, Italy..
    Andarala, Maryna
    European Soc Cardiol, European Heart House,2035 Route Colles, F-06903 Sophia Antipolis, France..
    Auricchio, Angelo
    Fdn Cardioctr Ticino, Div Cardiol, Via Tesserete 48, CH-6900 Lugano, Switzerland..
    Kuck, Karl-Heinz
    Asklepios Klin St Georg, Dept Cardiol, Lohmuhlenstr 5, D-20099 Hamburg, Germany..
    Blomström-Lundqvist, Carina
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology-Arrhythmia. Uppsala Univ, Inst Med Sci, Dept Cardiol, S-75185 Uppsala, Sweden..
    The European Lead Extraction ConTRolled (ELECTRa) study: a European Heart Rhythm Association (EHRA) Registry of Transvenous Lead Extraction Outcomes2017In: European Heart Journal, ISSN 0195-668X, E-ISSN 1522-9645, Vol. 38, no 40, p. 2995-3005Article in journal (Refereed)
    Abstract [en]

    Aims The European Lead Extraction ConTRolled Registry (ELECTRa), is a prospective registry of consecutive transvenous lead extraction (TLE) procedures conducted by the European Heart Rhythm Association (EHRA) in order to identify the safety and efficacy of the current practice of TLE Methods and results European centres performing TLE, invited by the organizing committee on behalf of EHRA, prospectively recruited all consecutive patients undergoing TLE at their institution. The primary endpoint was TLE safety defined by pre-discharge major procedure-related complications including death. Secondary endpoints included clinical and radiological success and overall complication rates. Outcomes were compared between Low Volume (LoV) vs. High Volume (HiV) centers (LoV < 30 and HiV >= 30 procedures/year). A total of 3555 consecutive patients (pts) of whom 3510 underwent TLE at 73 centres in 19 European countries were enrolled between November 2012 and May 2014. The primary endpoint of in-hospital procedure-related major complication rate was 1.7% [95% CI 1.3-2.1%] (58/3510 pts) including a mortality of 0.5% [95% CI 0.3-0.8%] (17/3510 pts). Approximately two-thirds (37/58) of these complications occurred during the procedure and one-third (21/58) in the post-operative period. The most common procedure related complications were those requiring pericardiocentesis or chest tube and/or surgical repair (1.4% [95% CI 1.0-1.8%]). Complete clinical and radiological success rates were 96.7% [95% CI 96.1-97.3%] and 95.7% [95% CI 95.2-96.2%], respectively. The all cause in-hospital major complications and deaths were significantly lower in HiV centres vs. LoV centres (2.4% [95% CI 1.9-3.0%] vs. 4.1% [95% CI 2.7-6.0%], P = 0.0146; and 1.2% [95% CI 0.8-1.6%] vs. 2.5% [95% CI 1.5-4.1%] P = 0.0088), although those related to the procedure did not reach statistical significance. Radiological and clinical successes were more frequent in HiV vs. LoV centres. Conclusion The ELECTRa study is the largest prospective registry on TLE and confirmed the safety and efficacy of the current practice of TLE. Lead extraction was associated with a higher success rate with lower all cause complication and mortality rates in high volume compared with low volume centres.

  • 42. Bongiorni, Maria Grazia
    et al.
    Proclemer, Alessandro
    Dobreanu, Dan
    Marinskis, Germanas
    Pison, Laurent
    Blomström-Lundqvist, Carina
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology-Arrhythmia.
    Preferred tools and techniques for implantation of cardiac electronic devices in Europe: results of the European Heart Rhythm Association survey2013In: Europace, ISSN 1099-5129, E-ISSN 1532-2092, Vol. 15, no 11, p. 1664-1668Article in journal (Refereed)
    Abstract [en]

    The aim of this European Heart Rhythm Association (EHRA) survey was to assess clinical practice in relation to the tools and techniques used for cardiac implantable electronic devices procedures in the European countries. Responses to the questionnaire were received from 62 members of the EHRA research network. The survey involved high-, medium-, and low-volume implanting centres, performing, respectively, more than 200, 100199 and under 100 implants per year. The following topics were explored: the side approach for implantation, surgical techniques for pocket incision, first venous access for lead implantation, preference of lead fixation, preferred coil number for implantable cardioverter-defibrillator (ICD) leads, right ventricular pacing site, generator placement site, subcutaneous ICD implantation, specific tools and techniques for cardiac resynchronization therapy (CRT), lead implantation sequence in CRT, coronary sinus cannulation technique, target site for left ventricular lead placement, strategy in left ventricular lead implant failure, mean CRT implantation time, optimization of the atrioventricular (AV) and ventriculo-ventricular intervals, CRT implants in patients with permanent atrial fibrillation, AV node ablation in patients with permanent AF. This panoramic view allows us to find out the operator preferences regarding the techniques and tools for device implantation in Europe. The results showed different practices in all the fields we investigated, nevertheless the survey also outlines a good adherence to the common standards and recommendations.

  • 43. Bongiorni, Maria Grazia
    et al.
    Romano, Simone L
    Kennergren, Charles
    Butter, Christian
    Deharo, Jean Claude
    Kutarsky, Andrzej
    Rinaldi, Christopher Aldo
    Maggioni, Aldo P
    Blomström-Lundqvist, Carina
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology-Arrhythmia.
    Auricchio, Angelo
    ELECTRa (European Lead Extraction ConTRolled) Registry-Shedding light on transvenous lead extraction real-world practice in Europe2013In: Herzschrittmachertherapie & Elektrophysiologie, ISSN 0938-7412, E-ISSN 1435-1544, Vol. 24, no 3, p. 171-175Article in journal (Refereed)
    Abstract [en]

    With the growing recognition of the clinical need and wider indications for cardiovascular implantable electronic devices (CIED), the number of implant procedures has increased considerably. Consequently, the rate of complications related to these devices has also increased. Transvenous lead extraction (TLE) is the gold standard in the treatment of CIED-related infective complications and is often required in the management of lead malfunction. An increasing number of centers currently perform TLE procedures. The ELECTRa (European Lead Extraction ConTRolled) Registry is the first large prospective multicenter registry of consecutive patients undergoing TLE in Europe, conducted by the European Heart Rhythm Association (EHRA) and managed by the European Society of Cardiology (ESC) EURObservational Research Department. The primary objective of the registry is to evaluate the acute and long-term safety of TLE; the secondary objective is to describe the characteristics of the patients, the leads, the indications for TLE, and the tools and techniques currently used for TLE. About 100 centers will be enrolled on a voluntary basis from European countries; they are anonymous and stratified on the basis of their volume of activity into high-volume centers (> 30 patients/year) and low-volume centers: (≤ 30 patients/year). Each participating center will have to enroll and follow up for 1 year consecutively assessed patients undergoing TLE from November 2012 to January 2014. The target is to achieve a sample size of at least 3,500 patients for statistical analysis. Data will be collected using a Web-based system and will be audited at randomly selected centers. The official start was on 6 November. Eighty-nine centers have joined so far, 65 centers are currently active, those who have already obtained the approval of their own ethics committee, and 1,099 patients were enrolled at the end of June 2013. The independence of the registry, the consecutiveness of the patient enrolment, and the monitoring of the study are characteristics of this registry that will contribute to the scientific validity of the objectives to be achieved.

  • 44. Boriani, Giuseppe
    et al.
    Blomström-Lundqvist, Carina
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology-Arrhythmia.
    Hohnloser, Stefan H
    Bergfeldt, Lennart
    Botto, Giovanni L
    Capucci, Alessandro
    Lozano, Ignacio Fernández
    Goette, Andreas
    Israel, Carsten W
    Merino, José L
    Camm, A John
    Safety and efficacy of dronedarone from clinical trials to real-world evidence: implications for its use in atrial fibrillation2019In: Europace, ISSN 1099-5129, E-ISSN 1532-2092, Vol. 21, no 12, p. 1764-1775Article in journal (Refereed)
    Abstract [en]

    Efficacy and safety of dronedarone was shown in the ATHENA trial for paroxysmal or persistent atrial fibrillation (AF) patients. Further trials revealed safety concerns in patients with heart failure and permanent AF. This review summarizes insights from recent real-world studies and meta-analyses, including reports on efficacy, with focus on liver safety, mortality risk in patients with paroxysmal/persistent AF, and interactions of dronedarone with direct oral anticoagulants. Reports of rapidly progressing liver failure in dronedarone-prescribed patients in 2011 led to regulatory cautions about potential liver toxicity. Recent real-world evidence suggests dronedarone liver safety profile is similar to other antiarrhythmics and liver toxicity could be equally common with many Class III antiarrhythmics. Dronedarone safety concerns (increased mortality in patients with permanent AF) were raised based on randomized controlled trials (RCT) (ANDROMEDA and PALLAS), but comedication with digoxin may have increased the mortality rates in PALLAS, considering the dronedarone-digoxin pharmacokinetic (PK) interaction. Real-world data on apixaban-dronedarone interactions and edoxaban RCT observations suggest no significant safety risks for these drug combinations. Median trough plasma concentrations of dabigatran 110 mg during concomitant use with dronedarone are at acceptable levels, while PK data on the rivaroxaban-dronedarone interaction are unavailable. In RCTs and real-world studies, dronedarone significantly reduces AF burden and cardiovascular hospitalizations, and demonstrates a low risk for proarrhythmia in patients with paroxysmal or persistent AF. The concerns on liver safety must be balanced against the significant reduction in hospitalizations in patients with non-permanent AF and low risk for proarrhythmias following dronedarone treatment.

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  • 45. Boriani, Giuseppe
    et al.
    Fauchier, Laurent
    Aguinaga, Luis
    Beattie, James M
    Blomström-Lundqvist, Carina
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology-Arrhythmia. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology.
    Cohen, Ariel
    Dan, Gheorghe-Andrei
    Genovesi, Simonetta
    Israel, Carsten
    Joung, Boyoung
    Kalarus, Zbigniew
    Lampert, Rachel
    Malavasi, Vincenzo L
    Mansourati, Jacques
    Mont, Lluis
    Potpara, Tatjana
    Thornton, Andrew
    Lip, Gregory Y H
    European Heart Rhythm Association (EHRA) consensus document on management of arrhythmias and cardiac electronic devices in the critically ill and post-surgery patient, endorsed by endorsed by Heart Rhythm Society (HRS), Asia Pacific Heart Rhythm Society (APHRS), Cardiac Arrhythmia Society of Southern Africa (CASSA), and Latin American Heart Rhythm Society (LAHRS).2019In: Europace, ISSN 1099-5129, E-ISSN 1532-2092, Vol. 21, no 1, p. 7-8Article in journal (Refereed)
  • 46. Brugada, Josep
    et al.
    Blom, Nico
    Sarquella-Brugada, Georgia
    Blomström-Lundqvist, Carina
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology-Arrhythmia.
    Deanfield, John
    Janousek, Jan
    Abrams, Dominic
    Bauersfeld, Urs
    Brugada, Ramon
    Drago, Fabrizio
    de Groot, Natasja
    Happonen, Juha-Matti
    Hebe, Joachim
    Yen Ho, Siew
    Marijon, Eloi
    Paul, Thomas
    Pfammatter, Jean-Pierre
    Rosenthal, Eric
    Pharmacological and non-pharmacological therapy for arrhythmias in the pediatric population: EHRA and AEPC-Arrhythmia Working Group joint consensus statement2013In: Europace, ISSN 1099-5129, E-ISSN 1532-2092, Vol. 15, no 9, p. 1337-1382Article in journal (Refereed)
    Abstract [en]

    In children with structurally normal hearts, the mechanisms of arrhythmias are usually the same as in the adult patient. Some arrhythmias are particularly associated with young age and very rarely seen in adult patients. Arrhythmias in structural heart disease may be associated either with the underlying abnormality or result from surgical intervention. Chronic haemodynamic stress of congenital heart disease (CHD) might create an electrophysiological and anatomic substrate highly favourable for re-entrant arrhythmias.As a general rule, prescription of antiarrhythmic drugs requires a clear diagnosis with electrocardiographic documentation of a given arrhythmia. Risk-benefit analysis of drug therapy should be considered when facing an arrhythmia in a child. Prophylactic antiarrhythmic drug therapy is given only to protect the child from recurrent supraventricular tachycardia during this time span until the disease will eventually cease spontaneously. In the last decades, radiofrequency catheter ablation is progressively used as curative therapy for tachyarrhythmias in children and patients with or without CHD. Even in young children, procedures can be performed with high success rates and low complication rates as shown by several retrospective and prospective paediatric multi-centre studies. Three-dimensional mapping and non-fluoroscopic navigation techniques and enhanced catheter technology have further improved safety and efficacy even in CHD patients with complex arrhythmias.During last decades, cardiac devices (pacemakers and implantable cardiac defibrillator) have developed rapidly. The pacing generator size has diminished and the pacing leads have become progressively thinner. These developments have made application of cardiac pacing in children easier although no dedicated paediatric pacing systems exist.

  • 47. Brugada, Josep
    et al.
    Katritsis, Demosthenes G
    Arbelo, Elena
    Arribas, Fernando
    Bax, Jeroen J
    Blomström-Lundqvist, Carina
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology-Arrhythmia. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology.
    Calkins, Hugh
    Corrado, Domenico
    Deftereos, Spyridon G
    Diller, Gerhard-Paul
    Gomez-Doblas, Juan J
    Gorenek, Bulent
    Grace, Andrew
    Ho, Siew Yen
    Kaski, Juan-Carlos
    Kuck, Karl-Heinz
    Lambiase, Pier David
    Sacher, Frederic
    Sarquella-Brugada, Georgia
    Suwalski, Piotr
    Zaza, Antonio
    2019 ESC Guidelines for the management of patients with supraventricular tachycardia: The Task Force for the management of patients with supraventricular tachycardia of the European Society of Cardiology (ESC): Developed in collaboration with the Association for European Paediatric and Congenital Cardiology (AEPC)2020In: European Heart Journal, ISSN 0195-668X, E-ISSN 1522-9645, Vol. 41, no 5, p. 655-720Article in journal (Refereed)
  • 48. Calkins, Hugh
    et al.
    Hindricks, Gerhard
    Cappato, Riccardo
    Kim, Young-Hoon
    Saad, Eduardo B
    Aguinaga, Luis
    Akar, Joseph G
    Badhwar, Vinay
    Brugada, Josep
    Camm, John
    Chen, Peng-Sheng
    Chen, Shih-Ann
    Chung, Mina K
    Cosedis Nielsen, Jens
    Curtis, Anne B
    Davies, D Wyn
    Day, John D
    d'Avila, André
    Natasja de Groot, N M S
    Di Biase, Luigi
    Duytschaever, Mattias
    Edgerton, James R
    Ellenbogen, Kenneth A
    Ellinor, Patrick T
    Ernst, Sabine
    Fenelon, Guilherme
    Gerstenfeld, Edward P
    Haines, David E
    Haissaguerre, Michel
    Helm, Robert H
    Hylek, Elaine
    Jackman, Warren M
    Jalife, Jose
    Kalman, Jonathan M
    Kautzner, Josef
    Kottkamp, Hans
    Kuck, Karl Heinz
    Kumagai, Koichiro
    Lee, Richard
    Lewalter, Thorsten
    Lindsay, Bruce D
    Macle, Laurent
    Mansour, Moussa
    Marchlinski, Francis E
    Michaud, Gregory F
    Nakagawa, Hiroshi
    Natale, Andrea
    Nattel, Stanley
    Okumura, Ken
    Packer, Douglas
    Pokushalov, Evgeny
    Reynolds, Matthew R
    Sanders, Prashanthan
    Scanavacca, Mauricio
    Schilling, Richard
    Tondo, Claudio
    Tsao, Hsuan-Ming
    Verma, Atul
    Wilber, David J
    Yamane, Teiichi
    Blomström-Lundqvist, Carina
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology-Arrhythmia.
    2017 HRS/EHRA/ECAS/APHRS/SOLAECE expert consensus statement on catheter and surgical ablation of atrial fibrillation.2018In: Europace, ISSN 1099-5129, E-ISSN 1532-2092, Vol. 20, no 1, p. e1-e160Article in journal (Refereed)
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    fulltext
  • 49.
    Camm, A. J.
    et al.
    St Georges Univ London, Cranmer Terrace, London SW17 0RE, England..
    Savelieva, I.
    St Georges Univ London, Cranmer Terrace, London SW17 0RE, England..
    Potpara, T.
    Univ Belgrade, Cardiol Clin, Sch Med, Clin Ctr Serbia, Belgrade, Serbia..
    Hindriks, G.
    Herzzentrum Leipzig GmbH, Dept Electrophysiol, Leipzig, Germany..
    Pison, L.
    Maastricht Univ, Dept Cardiol, Med Ctr, NL-6200 MD Maastricht, Netherlands.;Univ Limburg, Cardiovasc Res Inst, NL-6200 MD Maastricht, Netherlands..
    Blomström-Lundqvist, Carina
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology-Arrhythmia.
    The changing circumstance of atrial fibrillation: progress towards precision medicine2016In: Journal of Internal Medicine, ISSN 0954-6820, E-ISSN 1365-2796, Vol. 279, no 5, p. 412-427Article, review/survey (Refereed)
    Abstract [en]

    The prevalence of atrial fibrillation (AF) in the general population is between 1% and 2% in the developed world and is higher in men than in women. The arrhythmia occurs much more commonly in the elderly, and the estimated lifetime risk of developing AF is one in four for men and women aged 40 years and above. Projected data from multiple population-based studies in the USA and Europe predict a two- to threefold increase in the number of AF patients by 2060. The high lifetime risk of AF and increased longevity underscore the important public health burden posed by this arrhythmia worldwide. AF has multiple aetiologies and a broad variety of presentations. The primary pathologies underlying or promoting the occurrence of AF vary more than for any other cardiac arrhythmia, ranging from autonomic imbalance to organic heart disease and metabolic disorders, such as diabetes mellitus, metabolic syndrome, hyperthyroidism and kidney disease, and lifestyle factors such as smoking, alcohol consumption and participation in endurance sports. Biomarkers are increasingly being investigated and, together with clinical and genetic factors, will eventually lead to a clinically valuable detailed classification of AF which will also incorporate pathophysiological determinants and mechanisms of the arrhythmia. In turn, this will allow the development and application of precision medicine to this troublesome arrhythmia.

  • 50. Camm, A John
    et al.
    Amarenco, Pierre
    Haas, Sylvia
    Hess, Susanne
    Kirchhof, Paulus
    Kuhls, Silvia
    van Eickels, Martin
    Turpie, Alexander G G
    Blomström Lundqvist, Carina
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology-Arrhythmia.
    XANTUS: a real-world, prospective, observational study of patients treated with rivaroxaban for stroke prevention in atrial fibrillation.2016In: European Heart Journal, ISSN 0195-668X, E-ISSN 1522-9645, Vol. 37, no 14, p. 1145-53Article in journal (Refereed)
    Abstract [en]

    AIMS: Although non-vitamin K antagonist oral anticoagulants are recommended for stroke prevention in patients with non-valvular atrial fibrillation (NVAF) based on clinical trial results, there is a need for safety and efficacy data from unselected patients in everyday clinical practice. XANTUS investigated the safety and efficacy of the Factor Xa inhibitor rivaroxaban in routine clinical use in the NVAF setting.

    METHODS AND RESULTS: Consecutive consenting patients with NVAF newly started on rivaroxaban were eligible and were followed up at ∼3-month intervals for 1 year, or for at least 30 days after permanent discontinuation. All adverse events (AEs) were recorded as AEs or serious AEs; major outcomes (including major bleeding, symptomatic thromboembolic events [stroke, systemic embolism, transient ischaemic attack, and myocardial infarction], and all-cause death) were centrally adjudicated. There were 6784 patients treated with rivaroxaban at 311 centres in Europe, Israel, and Canada. Mean patient age was 71.5 years (range 19-99), 41% were female, and 9.4% had documented severe or moderate renal impairment (creatinine clearance <50 mL/min). The mean CHADS2 and CHA2DS2-VASc scores were 2.0 and 3.4, respectively; 859 (12.7%) patients had a CHA2DS2-VASc score of 0 or 1. The mean treatment duration was 329 days. Treatment-emergent major bleeding occurred in 128 patients (2.1 events per 100 patient-years), 118 (1.9 events per 100 patient-years) died, and 43 (0.7 events per 100 patient-years) suffered a stroke.

    CONCLUSION: XANTUS is the first international, prospective, observational study to describe the use of rivaroxaban in a broad NVAF patient population. Rates of stroke and major bleeding were low in patients receiving rivaroxaban in routine clinical practice.

    TRIAL REGISTRATION NUMBER: Clinicaltrials.gov: NCT01606995.

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