title: Results from a single-blind, randomized study comparing the impact of different ablation approaches on long-term procedure outcome in coexistent atrial fibrillation and flutter (APPROVAL).
abstract: BACKGROUND
  This study examined the impact of different ablation strategies on atrial fibrillation (AF) recurrence and quality of life in coexistent AF and atrial flutter (AFL).
  
  
  RESULTS
  Three-hundred sixty enrolled patients with documented AF and AFL were blinded and randomized to group 1, AF±AFL ablation (n=182), or group 2, AFL ablation only (n=178). AF recurrence was evaluated with event recording and 7-day Holter at 3, 6, 9, and 12-month follow-ups. Quality of life was assessed at baseline and at the 12-month follow-up with 4 questionnaires: the Medical Outcome Study Short Form, the Hospital Anxiety and Depression Score, the Beck Depression Inventory, and the State-Trait Anxiety Inventory. Of the 182 patients in group 1, 58 (age, 63±8 years; 78% male; left ventricular ejection fraction, 59±8%) had AF+AFL ablation and 124 (age, 61±11 years; 72% male; left ventricular ejection fraction, 59±7%) had AF ablation only. In group 2 (age, 62±9 years; 76% male; left ventricular ejection fraction, 58±10%), only AFL was ablated by achieving bidirectional isthmus conduction block. Baseline characteristics were not different across groups. At 21±9 months of follow-up, 117 in group 1 (64%) and 34 in group 2 (19%) were arrhythmia free (P<0.001). In group 1, scores on most quality-of-life subscales showed significant improvement at follow-up, whereas group 2 patients derived relatively minor benefit.
  
  
  CONCLUSIONS
  In coexistent AF and AFL, lower recurrence rate and better quality of life are associated with AF ablation only or AF+AFL ablation than with lone AFL ablation. Furthermore, quality of life directly correlates with freedom from arrhythmia, as shown in this study for the first time in patients blinded to the procedure.
  
  
  BACKGROUND
  URL: http://www.clinicaltrial.gov/. Unique identifier: NCT01439386.
authors.affiliation: Texas Cardiac Arrhythmia Institute, St. David's Medical Center, 3000 N I-35, Ste 720, Austin, TX 78705, USA.
authors.forename: Sanghamitra
authors.initials: S
authors.lastname: Mohanty
authors.forename: Prasant
authors.initials: P
authors.lastname: Mohanty
authors.forename: Luigi
authors.initials: L
authors.lastname: Di Biase
authors.forename: Rong
authors.initials: R
authors.lastname: Bai
authors.forename: Pasquale
authors.initials: P
authors.lastname: Santangeli
authors.forename: Michela
authors.initials: M
authors.lastname: Casella
authors.forename: Antonio
authors.initials: A
authors.lastname: Dello Russo
authors.forename: Claudio
authors.initials: C
authors.lastname: Tondo
authors.forename: Sakis
authors.initials: S
authors.lastname: Themistoclakis
authors.forename: Antonio
authors.initials: A
authors.lastname: Raviele
authors.forename: Antonio
authors.initials: A
authors.lastname: Rossillo
authors.forename: Andrea
authors.initials: A
authors.lastname: Corrado
authors.forename: Gemma
authors.initials: G
authors.lastname: Pelargonio
authors.forename: Giovanni
authors.initials: G
authors.lastname: Forleo
authors.forename: Andrea
authors.initials: A
authors.lastname: Natale
mesh_terms: D000368:Aged; D001281:Atrial Fibrillation / Q000175:diagnosis / Q000453:epidemiology* / Q000601:surgery*; D001282:Atrial Flutter / Q000175:diagnosis / Q000453:epidemiology* / Q000601:surgery*; D017115:Catheter Ablation / Q000379:methods* / Q000639:trends*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D016037:Single-Blind Method; D013997:Time Factors; D016896:Treatment Outcome
keywords: ablation techniques; atrial fibrillation; atrial flutter; pulmonary veins; quality of life; recurrence