title: Radiofrequency ablation as initial therapy in paroxysmal atrial fibrillation: results on health-related quality of life and symptom burden. The MANTRA-PAF trial.
abstract: OBJECTIVE
  The Medical ANtiarrhythmic Treatment or Radiofrequency Ablation in Paroxysmal Atrial Fibrillation (MANTRA-PAF) trial assessed the long-term efficacy of an initial strategy of radiofrequency ablation (RFA) vs. antiarrhythmic drug therapy (AAD) as first-line treatment for patients with PAF. In this substudy, we evaluated the effect of these treatment modalities on the Health-Related Quality of Life (HRQoL) and symptom burden of patients at 12 and 24 months.
  
  
  RESULTS
  During the study period, 294 patients were enrolled in the MANTRA-PAF trial and randomized to receive AAD (N = 148) or RFA (N = 146). Two generic questionnaires were used to assess the HRQoL [Short Form-36 (SF-36) and EuroQol-five dimensions (EQ-5D)], and the Arrhythmia-Specific questionnaire in Tachycardia and Arrhythmia (ASTA) was used to evaluate the symptoms appearing during the trial. All comparisons were made on an intention-to-treat basis. Both randomization groups showed significant improvements in assessments with both SF-36 and EQ-5D, at 24 months. Patients randomized to RFA showed significantly greater improvement in four physically related scales of the SF-36. The three most frequently reported symptoms were breathlessness during activity, pronounced tiredness, and worry/anxiety. In both groups, there was a significant reduction in ASTA symptom index and in the severity of seven of the eight symptoms over time.
  
  
  CONCLUSIONS
  Both AAD and RFA as first-line treatment resulted in substantial improvement of HRQoL and symptom burden in patients with PAF. Patients randomized to RFA showed greater improvement in physical scales (SF-36) and the EQ-visual analogue scale.
  
  
  BACKGROUND
  URL http://www.clinicaltrials.gov. Unique identifier: NCT00133211.
authors.affiliation: Department of Cardiology and Department of Medical and Health Sciences, Linköping University, Linköping, Sweden hakan.walfridsson@lio.se.
authors.forename: H
authors.initials: H
authors.lastname: Walfridsson
authors.affiliation: Division of Nursing Science, Department of Medical and Health Sciences, Linkoping University, Linkoping, Sweden.
authors.forename: U
authors.initials: U
authors.lastname: Walfridsson
authors.affiliation: Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.
authors.forename: J Cosedis
authors.initials: JC
authors.lastname: Nielsen
authors.affiliation: Gentofte University Hospital, Copenhagen, Denmark.
authors.forename: A
authors.initials: A
authors.lastname: Johannessen
authors.affiliation: Heart Center Co. Tampere University Hospital, Tampere, Finland.
authors.forename: P
authors.initials: P
authors.lastname: Raatikainen
authors.affiliation: Department of Cardiology and Department of Medical and Health Sciences, Linköping University, Linköping, Sweden.
authors.forename: M
authors.initials: M
authors.lastname: Janzon
authors.affiliation: Department of Medical and Health Sciences, Linköping University, Linköping, Sweden.
authors.forename: L A
authors.initials: LA
authors.lastname: Levin
authors.affiliation: Department of Medical and Health Sciences, Linköping University, Linköping, Sweden.
authors.forename: M
authors.initials: M
authors.lastname: Aronsson
authors.affiliation: Leipzig University Hospital, Leipzig, Germany.
authors.forename: G
authors.initials: G
authors.lastname: Hindricks
authors.affiliation: Lund University Hospital, Sweden.
authors.forename: O
authors.initials: O
authors.lastname: Kongstad
authors.affiliation: Rigshospitalet, Copenhagen, Denmark.
authors.forename: S
authors.initials: S
authors.lastname: Pehrson
authors.affiliation: University Hospital, Örebro, Sweden.
authors.forename: A
authors.initials: A
authors.lastname: Englund
authors.affiliation: Kuopio University Hospital, Kuopio, Finland.
authors.forename: J
authors.initials: J
authors.lastname: Hartikainen
authors.affiliation: UNI-C, Danish Information Technology Centre for Education and Research, Aarhus, Denmark.
authors.forename: L S
authors.initials: LS
authors.lastname: Mortensen
authors.affiliation: Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.
authors.forename: P S
authors.initials: PS
authors.lastname: Hansen
mesh_terms: D000328:Adult; D000368:Aged; D000889:Anti-Arrhythmia Agents / Q000627:therapeutic use*; D001281:Atrial Fibrillation / Q000628:therapy*; D017115:Catheter Ablation; D017281:Cost of Illness; D005260:Female; D005424:Flecainide / Q000627:therapeutic use; D006304:Health Status; D006801:Humans; D008297:Male; D008875:Middle Aged; D011405:Propafenone / Q000627:therapeutic use; D011788:Quality of Life; D016896:Treatment Outcome
chemical_list: D000889:Anti-Arrhythmia Agents; D011405:Propafenone; D005424:Flecainide
keywords: Antiarrhythmic drug treatment; Atrial fibrillation; Catheter ablation; First-line therapy; Quality of life