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Effect of Catheter Ablation vs Antiarrhythmic Medication on Quality of Life in Patients With Atrial Fibrillation: The CAPTAF Randomized Clinical Trial
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology-Arrhythmia.
Univ Gothenburg, Sahlgrenska Acad, Dept Mol & Clin Med Cardiol, Inst Med, Gothenburg, Sweden;Sahlgrens Univ Hosp, Dept Cardiol, Gothenburg, Sweden.
Karolinska Univ Hosp, Heart & Vasc Theme, Stockholm, Sweden.
Umea Univ, Ctr Heart, Umea, Sweden;Umea Univ, Dept Publ Hlth & Clin Med, Umea, Sweden.
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2019 (English)In: 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) Published
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.

Place, publisher, year, edition, pages
2019. Vol. 321, no 11, p. 1059-1068
Keywords [en]
atrial fibrillation, catheter ablation, antiarrhythmic drug, quality of life
National Category
Cardiac and Cardiovascular Systems
Research subject
Cardiology
Identifiers
URN: urn:nbn:se:uu:diva-362212DOI: 10.1001/jama.2019.0335ISI: 000461683500014PubMedID: 30874754OAI: oai:DiVA.org:uu-362212DiVA, id: diva2:1252642
Funder
Swedish Heart Lung Foundation, 20150751Swedish Research Council, 2014-36708-117759-70Medtronic, SwedenAvailable from: 2018-10-02 Created: 2018-10-02 Last updated: 2019-05-06Bibliographically approved
In thesis
1. Outcomes and safety of new techniques for pulmonary vein isolation in patients with paroxysmal and persistent atrial fibrillation: A study based on randomised trials and registries
Open this publication in new window or tab >>Outcomes and safety of new techniques for pulmonary vein isolation in patients with paroxysmal and persistent atrial fibrillation: A study based on randomised trials and registries
2018 (English)Doctoral thesis, comprehensive summary (Other academic)
Abstract [en]

Atrial fibrillation (AF) is a common disease with a high prevalence in the adult population. Treatment of AF encompasses antiarrhythmic drugs and catheter ablation to reduce symptoms. The aim of this thesis was to study how to best alleviate symptoms of AF in a safe and efficient way comparing pharmacological treatment and the two dominating catheter ablation techniques, cryoballoon (CRYO) ablation and point-by-point radiofrequency (RF) ablation.

Quality of life improved more for those AF patients randomised to treatment with catheter ablation compared to those treated with antiarrhythmic medication after 12 months of follow up (n=155).

We evaluated a proposed optimised CRYO ablation protocol and randomised 140 patients to a single cryoballoon application per vein guided by a mapping catheter (Single cryo) or two cryoballoon applications (Routine). Acute pulmonary vein isolation rate did not differ. Procedure time decreased by 19 minutes with a lower complication rate in the Single cryo-arm. Freedom from AF after one procedure at 12 months did not differ; 73.9.0% (Single cryo) versus 71.4% (Routine).

CRYO ablation was also assessed in persistent AF and paroxysmal AF. Freedom from arrhythmia recurrence was lower after a single ablation in persistent AF (64.9%) compared with paroxysmal AF (82.2%) after 12 months. However, the reduction of AF symptoms and quality of life was excellent in both groups and did not differ after 12 months.

Patients undergoing their first AF ablation with CRYO or RF were included in a registry study. After 12 months, freedom from AF was equal irrespective of AF type, but there was a lower re-ablation rate and need for continued antiarrhythmic drug treatment after CRYO ablation. Procedure duration was reduced by 40 minutes with CRYO and complication rates did not differ,

In conclusion, catheter ablation reduces AF symptoms more than antiarrhythmic drugs and cryoballoon ablation can be further optimised with reduced procedure times and improved safety. Cryoballoon ablation is as efficacious as RF ablation as a first-line therapy in both paroxysmal and persistent AF and the lower re-ablation rates and  shorter procedure times may have important clinical implications when choosing AF ablation technique.

Place, publisher, year, edition, pages
Uppsala: Acta Universitatis Upsaliensis, 2018. p. 81
Series
Digital Comprehensive Summaries of Uppsala Dissertations from the Faculty of Medicine, ISSN 1651-6206 ; 1509
Keywords
atrial fibrillation, antiarrhythmic drugs, ablation, cryoballoon, radiofrequency, pulmonary vein isolation, quality of life, arrhythmia monitoring, implantable cardiac monitor, atrial fibrillation burden, health economics
National Category
Cardiac and Cardiovascular Systems
Research subject
Cardiology
Identifiers
urn:nbn:se:uu:diva-363259 (URN)978-91-513-0486-1 (ISBN)
Public defence
2018-12-05, Enghoff-salen, Akademiska sjukhuset, ingång 50, bv, Uppsala, 13:00 (English)
Opponent
Supervisors
Available from: 2018-11-14 Created: 2018-10-16 Last updated: 2018-11-30

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Blomström-Lundqvist, CarinaMalmborg, HelenaLönnerholm, StefanMörtsell, David

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