2017 HRS / EHRA / ECAS / APHRS / SOLAECE expert consensus statement on catheter and surgical ablation of atrial fibrillation
Johns Hopkins University1, Leipzig University2, Korea University3, Yale University4, West Virginia University5, University of Barcelona6, St George's, University of London7, Indiana University8, National Yang-Ming University9, Cleveland Clinic10, Aarhus University11, University at Buffalo12, Imperial College London13, Primary Children's Hospital14, Erasmus University Rotterdam15, Yeshiva University16, Ghent University17, Baylor University18, Virginia Commonwealth University19, Harvard University20, Federal University of São Paulo21, University of California, San Francisco22, Beaumont Hospital23, Boston University24, University of Oklahoma25, Carlos III Health Institute26, University of Michigan27, University of Melbourne28, Saint Louis University29, Université de Montréal30, University of Pennsylvania31, McGill University32, Mayo Clinic33, Lahey Hospital & Medical Center34, Royal Adelaide Hospital35, University of Milan36, University of Toronto37, Loyola University Chicago38, Jikei University School of Medicine39
TL;DR: This 2017 Consensus Statement is to provide a state-of-the-art review of the field of catheter and surgical ablation of AF and to report the findings of a writing group, convened by these five international societies.
About: This article is published in Heart Rhythm.The article was published on 2017-10-01. It has received 1626 citations till now. The article focuses on the topics: Catheter ablation & Evidence-based medicine.
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Mayo Clinic1, Duke University2, University of Washington3, National Institutes of Health4, Cardiovascular Institute of the South5, University of Missouri6, Primary Children's Hospital7, Ruhr University Bochum8, Moscow State University9, Loyola University Chicago10, Humanitas University11, Leipzig University12, Thomas Jefferson University13, Pennsylvania State University14, Columbia University15
TL;DR: Among patients with AF, the strategy of catheter ablation, compared with medical therapy, did not significantly reduce the primary composite end point of death, disabling stroke, serious bleeding, or cardiac arrest, which should be considered in interpreting the results of the trial.
Abstract: Importance Catheter ablation is effective in restoring sinus rhythm in atrial fibrillation (AF), but its effects on long-term mortality and stroke risk are uncertain. Objective To determine whether catheter ablation is more effective than conventional medical therapy for improving outcomes in AF. Design, Setting, and Participants The Catheter Ablation vs Antiarrhythmic Drug Therapy for Atrial Fibrillation trial is an investigator-initiated, open-label, multicenter, randomized trial involving 126 centers in 10 countries. A total of 2204 symptomatic patients with AF aged 65 years and older or younger than 65 years with 1 or more risk factors for stroke were enrolled from November 2009 to April 2016, with follow-up through December 31, 2017. Interventions The catheter ablation group (n = 1108) underwent pulmonary vein isolation, with additional ablative procedures at the discretion of site investigators. The drug therapy group (n = 1096) received standard rhythm and/or rate control drugs guided by contemporaneous guidelines. Main Outcomes and Measures The primary end point was a composite of death, disabling stroke, serious bleeding, or cardiac arrest. Among 13 prespecified secondary end points, 3 are included in this report: all-cause mortality; total mortality or cardiovascular hospitalization; and AF recurrence. Results Of the 2204 patients randomized (median age, 68 years; 37.2% female; 42.9% had paroxysmal AF and 57.1% had persistent AF), 89.3% completed the trial. Of the patients assigned to catheter ablation, 1006 (90.8%) underwent the procedure. Of the patients assigned to drug therapy, 301 (27.5%) ultimately received catheter ablation. In the intention-to-treat analysis, over a median follow-up of 48.5 months, the primary end point occurred in 8.0% (n = 89) of patients in the ablation group vs 9.2% (n = 101) of patients in the drug therapy group (hazard ratio [HR], 0.86 [95% CI, 0.65-1.15];P = .30). Among the secondary end points, outcomes in the ablation group vs the drug therapy group, respectively, were 5.2% vs 6.1% for all-cause mortality (HR, 0.85 [95% CI, 0.60-1.21];P = .38), 51.7% vs 58.1% for death or cardiovascular hospitalization (HR, 0.83 [95% CI, 0.74-0.93];P = .001), and 49.9% vs 69.5% for AF recurrence (HR, 0.52 [95% CI, 0.45-0.60];P Conclusions and Relevance Among patients with AF, the strategy of catheter ablation, compared with medical therapy, did not significantly reduce the primary composite end point of death, disabling stroke, serious bleeding, or cardiac arrest. However, the estimated treatment effect of catheter ablation was affected by lower-than-expected event rates and treatment crossovers, which should be considered in interpreting the results of the trial. Trial Registration ClinicalTrials.gov Identifier:NCT00911508
864 citations
St George's, University of London1, National Institutes of Health2, Sahlgrenska University Hospital3, University of Paris4, University of Padua5, University of Washington6, Technische Universität München7, University of Hasselt8, VA Palo Alto Healthcare System9, Paracelsus Private Medical University of Salzburg10, University of Parma11, Erasmus University Rotterdam12, University of Glasgow13, Hartford Hospital14, Unica Corporation15, Katholieke Universiteit Leuven16, University of Bern17
652 citations
599 citations
25 Apr 2014
TL;DR: It is concluded that autonomic nerve activity plays an important role in the initiation and maintenance of AF, and modulating autonomic nervous function may contribute to AF control.
Abstract: Autonomic nervous system activation can induce significant and heterogeneous changes of atrial electrophysiology and induce atrial tachyarrhythmias, including atrial tachycardia and atrial fibrillation (AF). The importance of the autonomic nervous system in atrial arrhythmogenesis is also supported by circadian variation in the incidence of symptomatic AF in humans. Methods that reduce autonomic innervation or outflow have been shown to reduce the incidence of spontaneous or induced atrial arrhythmias, suggesting that neuromodulation may be helpful in controlling AF. In this review, we focus on the relationship between the autonomic nervous system and the pathophysiology of AF and the potential benefit and limitations of neuromodulation in the management of this arrhythmia. We conclude that autonomic nerve activity plays an important role in the initiation and maintenance of AF, and modulating autonomic nerve function may contribute to AF control. Potential therapeutic applications include ganglionated plexus ablation, renal sympathetic denervation, cervical vagal nerve stimulation, baroreflex stimulation, cutaneous stimulation, novel drug approaches, and biological therapies. Although the role of the autonomic nervous system has long been recognized, new science and new technologies promise exciting prospects for the future.
361 citations
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01 Jan 2003
TL;DR: TheSF-36 is a generic health status measure which has gained popularity as a measure of outcome in a wide variety of patient groups and social and the contribution of baseline health, sociodemographic and work-related factors to the SF-36 Health Survey: manual and interpretation guide is tested.
Abstract: The SF-36 is a generic health status measure which has gained popularity as a measure of outcome in a wide variety of patient groups and social. The 36-Item Short-Form Health Survey (SF-36) and its shorter version, the SF-12, are the measures SF-36 Health Survey manual and interpretation guide. Health Services Research Unit, University of Oxford, Headington. Postal survey using a questionnaire booklet, containing the SF-36-II and questions. The SMFA, the health survey short form (SF-36) along with a region-specific questionnaire Gandek B. SF-36 Health Survey: Manual and Interpretation Guide. The SF Health Surveys capture practical, reliable and valid information about or need assistance with an FDA dossier, we will guide you every step of the way. The 36 Item Short Form Health Survey (SF-36) is a generic patient-reported outcome measure, SF-36 health survey: Manual and interpretation guide. Boston. The SF-36 Health Survey is a self-administered questionnaire of 36 questions to M, and Gendek, B. SF-36 Health Survey: Manual and Interpretation Guide. The patients' self-assessment of QL was measured with the SF-36TM form at 3, M & Gandek B. SF-36 Health Survey: Manual and Interpretation Guide 1993. We aimed to determine whether health outcomes (pain severity and quality of life Gandeck B. SF-36 Health survey manual and interpretation Guide. Boston:. Ware JE (1993) Health survey manual and interpretation guide. Thomas KJ, Usherwood T et al (1992) Validating the SF-36 health survey questionnaire: new. Health Related Quality of Life (HRQL) is one of the increasing subjects used Jr, Kristin KS., Kosinski M, SF-36 Health Survey Manual and Interpretation Guide. They commonly take up low paid manual jobs and work long hours (6), mostly live in conditions that SF-36 health survey : manual and interpretation guide. Additionally, the contribution of baseline health, sociodemographic and work-related factors to the SF-36 Health Survey: manual and interpretation guide. cal Outcomes Study 36-Item Short-Form Health Survey (SF-36) to reproduce the Physical Component SF-36 health survey: Manual and interpretation guide. results from a national survey. Archives of to test the construct validity of the SF-36 Health Survey in Ten Countries: Survey: manual and interpretation guide. The Short Form-36 health survey (SF-36v2) is a widely used patient-reported Dewey JE, Gandek B. SF-36 health survey: manual and interpretation guide. Ware JE, Snow KK, Kosinski M, Gandek B. SF-36 Health Survey Manual and Interpretation Guide. Boston, MA: New England Medical Center, the Health Institute. The Short Form Health Survey 36 (SF-36) and a cross-cultural validated Snow KK, Kosinski M. SF-36 Health Survey: Manual and Interpretation Guide. the SF-36 Health Survey subscales, the Hospital Anxiety and Depression Scale. Social Provisions activities emerged as enhancing meaning in life for the residents. A systematic their experience regarding the questions in the interview guide. SF-36 Health Survey manual and interpretation guide. Boston:. ABSTRACT Regression methods were used to select and score 12 items from the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36). SF-36 physical function tended to be better with the HFC (p=0.08) in addition to SF-36 SF-36 Health Survey Manual and Interpretation Guide. Boston: The. HRQL was measured by the Greek version of SF-36 Health Survey and further B., Kosinski, M. SF-36 Health Survey Manual and Interpretation Guide. SF-36 ® (MOS 36-Item Short-Form Health Survey) SF-36 ® ? PDFSF-36 Health Survey Manual and Interpretation Guide John E. Ware, Jr., Ph.D. with Kristin K. Subjects (N = 79) completed the SF-36 at baseline and every three weeks throughout the treatment SF-36v2 health survey: manual and interpretation guide.
11,954 citations
TL;DR: In patients with atrial fibrillation, dabigatran given at a dose of 110 mg was associated with rates of stroke and systemic embolism that were similar to those associated with warfarin, as well as lower rates of major hemorrhage.
Abstract: Background Warfarin reduces the risk of stroke in patients with atrial fibrillation but increases the risk of hemorrhage and is difficult to use. Dabigatran is a new oral direct thrombin inhibitor. Methods In this noninferiority trial, we randomly assigned 18,113 patients who had atrial fibrillation and a risk of stroke to receive, in a blinded fashion, fixed doses of dabigatran — 110 mg or 150 mg twice daily — or, in an unblinded fashion, adjusted-dose warfarin. The median duration of the follow-up period was 2.0 years. The primary outcome was stroke or systemic embolism. Results Rates of the primary outcome were 1.69% per year in the warfarin group, as compared with 1.53% per year in the group that received 110 mg of dabigatran (relative risk with dabigatran, 0.91; 95% confidence interval [CI], 0.74 to 1.11; P<0.001 for noninferiority) and 1.11% per year in the group that received 150 mg of dabigatran (relative risk, 0.66; 95% CI, 0.53 to 0.82; P<0.001 for superiority). The rate of major bleeding was 3.36% per year in the warfarin group, as compared with 2.71% per year in the group receiving 110 mg of dabigatran (P = 0.003) and 3.11% per year in the group receiving 150 mg of dabigatran (P = 0.31). The rate of hemorrhagic stroke was 0.38% per year in the warfarin group, as compared with 0.12% per year with 110 mg of dabigatran (P<0.001) and 0.10% per year with 150 mg of dabigatran (P<0.001). The mortality rate was 4.13% per year in the warfarin group, as compared with 3.75% per year with 110 mg of dabigatran (P = 0.13) and 3.64% per year with 150 mg of dabigatran (P = 0.051). Conclusions In patients with atrial fibrillation, dabigatran given at a dose of 110 mg was associated with rates of stroke and systemic embolism that were similar to those associated with warfarin, as well as lower rates of major hemorrhage. Dabigatran administered at a dose of 150 mg, as compared with warfarin, was associated with lower rates of stroke and systemic embolism but similar rates of major hemorrhage. (ClinicalTrials.gov number, NCT00262600.)
9,676 citations
TL;DR: In patients with atrial fibrillation, rivaroxaban was noninferior to warfarin for the prevention of stroke or systemic embolism and there was no significant between-group difference in the risk of major bleeding, although intracranial and fatal bleeding occurred less frequently in the rivroxaban group.
Abstract: Methods In a double-blind trial, we randomly assigned 14,264 patients with nonvalvular atrial fibrillation who were at increased risk for stroke to receive either rivaroxaban (at a daily dose of 20 mg) or dose-adjusted warfarin. The per-protocol, as-treated primary analysis was designed to determine whether rivaroxaban was noninferior to warfarin for the primary end point of stroke or systemic embolism. Results In the primary analysis, the primary end point occurred in 188 patients in the rivaroxaban group (1.7% per year) and in 241 in the warfarin group (2.2% per year) (hazard ratio in the rivaroxaban group, 0.79; 95% confidence interval [CI], 0.66 to 0.96; P<0.001 for noninferiority). In the intention-to-treat analysis, the primary end point occurred in 269 patients in the rivaroxaban group (2.1% per year) and in 306 patients in the warfarin group (2.4% per year) (hazard ratio, 0.88; 95% CI, 0.74 to 1.03; P<0.001 for noninferiority; P = 0.12 for superiority). Major and nonmajor clinically relevant bleeding occurred in 1475 patients in the rivaroxaban group (14.9% per year) and in 1449 in the warfarin group (14.5% per year) (hazard ratio, 1.03; 95% CI, 0.96 to 1.11; P = 0.44), with significant reductions in intracranial hemorrhage (0.5% vs. 0.7%, P = 0.02) and fatal bleeding (0.2% vs. 0.5%, P = 0.003) in the rivaroxaban group. Conclusions In patients with atrial fibrillation, rivaroxaban was noninferior to warfarin for the prevention of stroke or systemic embolism. There was no significant between-group difference in the risk of major bleeding, although intracranial and fatal bleeding occurred less frequently in the rivaroxaban group. (Funded by Johnson & Johnson and Bayer; ROCKET AF ClinicalTrials.gov number, NCT00403767.)
7,716 citations
TL;DR: The pulmonary veins are an important source of ectopic beats, initiating frequent paroxysms of atrial fibrillation and these foci respond to treatment with radio-frequency ablation.
Abstract: Background Atrial fibrillation, the most common sustained cardiac arrhythmia and a major cause of stroke, results from simultaneous reentrant wavelets. Its spontaneous initiation has not been studied. Methods We studied 45 patients with frequent episodes of atrial fibrillation (mean [±SD] duration, 344±326 minutes per 24 hours) refractory to drug therapy. The spontaneous initiation of atrial fibrillation was mapped with the use of multielectrode catheters designed to record the earliest electrical activity preceding the onset of atrial fibrillation and associated atrial ectopic beats. The accuracy of the mapping was confirmed by the abrupt disappearance of triggering atrial ectopic beats after ablation with local radio-frequency energy. Results A single point of origin of atrial ectopic beats was identified in 29 patients, two points of origin were identified in 9 patients, and three or four points of origin were identified in 7 patients, for a total of 69 ectopic foci. Three foci were in the right atrium...
7,487 citations
Duke University1, Boston University2, Bristol-Myers Squibb3, Lenox Hill Hospital4, Oslo University Hospital5, University of California, San Francisco6, University of Alberta7, University of Missouri8, University of New Mexico9, Mayo Clinic10, Tokai University11, Goethe University Frankfurt12, University of Adelaide13, Charles University in Prague14, Autonomous University of Madrid15, St. John's Medical College16, Uppsala University17
TL;DR: In patients with atrial fibrillation, apixaban was superior to warfarin in preventing stroke or systemic embolism, caused less bleeding, and resulted in lower mortality.
Abstract: A b s t r ac t Background Vitamin K antagonists are highly effective in preventing stroke in patients with atrial fibrillation but have several limitations. Apixaban is a novel oral direct factor Xa inhibitor that has been shown to reduce the risk of stroke in a similar population in comparison with aspirin. Methods In this randomized, double-blind trial, we compared apixaban (at a dose of 5 mg twice daily) with warfarin (target international normalized ratio, 2.0 to 3.0) in 18,201 patients with atrial fibrillation and at least one additional risk factor for stroke. The primary outcome was ischemic or hemorrhagic stroke or systemic em - bolism. The trial was designed to test for noninferiority, with key secondary objec - tives of testing for superiority with respect to the primary outcome and to the rates of major bleeding and death from any cause. Results The median duration of follow-up was 1.8 years. The rate of the primary outcome was 1.27% per year in the apixaban group, as compared with 1.60% per year in the war - farin group (hazard ratio with apixaban, 0.79; 95% confidence interval (CI), 0.66 to 0.95; P<0.001 for noninferiority; P = 0.01 for superiority). The rate of major bleeding was 2.13% per year in the apixaban group, as compared with 3.09% per year in the warfarin group (hazard ratio, 0.69; 95% CI, 0.60 to 0.80; P<0.001), and the rates of death from any cause were 3.52% and 3.94%, respectively (hazard ratio, 0.89; 95% CI, 0.80 to 0.99; P = 0.047). The rate of hemorrhagic stroke was 0.24% per year in the apixaban group, as compared with 0.47% per year in the warfarin group (hazard ra - tio, 0.51; 95% CI, 0.35 to 0.75; P<0.001), and the rate of ischemic or uncertain type of stroke was 0.97% per year in the apixaban group and 1.05% per year in the warfarin group (hazard ratio, 0.92; 95% CI, 0.74 to 1.13; P = 0.42). Conclusions In patients with atrial fibrillation, apixaban was superior to warfarin in preventing stroke or systemic embolism, caused less bleeding, and resulted in lower mortality. (Funded by Bristol-Myers Squibb and Pfizer; ARISTOTLE ClinicalTrials.gov number, NCT00412984.)
7,154 citations