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Is pulmonary vein isolation more effective than optimized antiarrhythmic drug therapy for improving general health in patients with symptomatic atrial fibrillation?
In this randomized clinical trial that included 155 patients with paroxysmal or persistent symptomatic atrial fibrillation despite use of antiarrhythmic medication, the improvement in quality of life at 12 months for those treated with catheter ablation compared with antiarrhythmic medication was 11.9 vs 3.1 points on the 0- to 100-point 36-Item Short-Form Health Survey questionnaire, a difference that was statistically and clinically significant.
In patients with either paroxysmal or persistent symptomatic atrial fibrillation despite medication, catheter ablation may help improve quality of life.
Quality of life is not a standard primary outcome in ablation trials, even though symptoms drive the indication.
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 β-blocker, with 4-year follow-up. Study dates were July 2008–September 2017. Major exclusions were ejection fraction <35%, left atrial diameter >60 mm, ventricular pacing dependency, and previous ablation.
Pulmonary vein isolation ablation (n = 79) or previously untested antiarrhythmic drugs (n = 76).
Main Outcomes and Measures
Primary outcome was 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.
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.
clinicaltrialsregister.eu Identifier: 2008-001384-11
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Corresponding Author: Carina Blomström-Lundqvist, MD, PhD, Department of Medical Science and Cardiology, Uppsala University, S-751 85 Uppsala, Sweden (firstname.lastname@example.org).
Accepted for Publication: January 13, 2019.
Author Contributions: Dr Blomström-Lundqvist had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Concept and design: Blomström-Lundqvist, Schwieler, Jensen, Bergfeldt.
Acquisition, analysis, or interpretation of data: All authors.
Drafting of the manuscript: Blomström-Lundqvist.
Critical revision of the manuscript for important intellectual content: Blomström-Lundqvist, Gizurarson, Schwieler, Jensen, Bergfeldt, Kennebäck, Rubulis, Malmborg, Raatikainen, Lönnerholm, Mörtsell.
Obtained funding: Blomström-Lundqvist.
Administrative, technical, or material support: Blomström-Lundqvist, Schwieler, Jensen, Bergfeldt, Kennebäck, Rubulis, Malmborg, Raatikainen, Lönnerholm, Höglund, Mörtsell.
Supervision: Blomström-Lundqvist, Schwieler, Jensen, Kennebäck, Raatikainen, Bergfeldt.
Conflict of Interest Disclosures: Dr Blomström-Lundqvist reports receiving grants from Medtronic during the conduct of the study; and personal fees from Bayer, Sanofi, Boston Scientific, and Merck Sharp & Dohme outside the submitted work. Dr Gizurarson reported a patent pending (WO 2015/149153A1). Dr Bergfeldt reports receiving personal fees from Sanofi, Bristol-Myers Squibb, Bayer, and Pfizer outside the submitted work. Dr Raatikainen reports receiving grants from Biosense Webster outside the submitted work. No other disclosures were reported.
Funding/Support: The study received unrestricted grants from the Swedish Heart-Lung Foundation (20150751), the Swedish Research Council (2014-36708-117759-70), and Medtronic AB.
Role of the Funder/Sponsor: No sponsor had any role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Data Sharing Statement: See Supplement 3.
Additional Contributions: Erika Nyberg, data manager, and Patrik Öhagen, statisticians at Uppsala Clinical Research Centre, Uppsala University, provided data management and statistical analysis and received compensation for their work. Stefan Lind, MD, Heart and Vascular Theme, Karolinska University Hospital, Stockholm, Sweden, collected data at follow-up visits, for which he received no compensation.
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