title: Stepwise ablation approach versus pulmonary vein isolation in patients with paroxysmal atrial fibrillation: Randomized controlled trial.
abstract: BACKGROUND
  Pulmonary vein isolation (PVI) is a central procedure for the treatment of paroxysmal atrial fibrillation (PAF). However, in patients with PAF and structural atrial disease, PVI may fail and cause progressive atrial remodeling, often leading to persistent/permanent atrial fibrillation.
  
  
  OBJECTIVE
  We performed a prospective, single-blind, 2-center randomized controlled trial to compare the efficacy of PVI alone with that of PVI plus stepwise ablation in achieving sinus rhythm and nonatrial arrhythmia inducibility in patients with PAF refractory to antiarrhythmic therapy.
  
  
  METHODS
  Patients were randomized to perform a first catheter ablation procedure either through PVI alone or through PVI plus substrate modification in stepwise ablation. Data were recorded at 3, 6, and 12 months after both ablation procedures. Patients who experienced atrial fibrillation/atrial tachycardia (AF/AT) recurrence were encouraged to undergo repeat ablation using the technique of the first ablation procedure.
  
  
  RESULTS
  A total of 150 patients were enrolled (mean age 62.8 ± 8.7 years; 92 (61.3%) men; 104 (69.3%) hypertensive; AF mean duration 10.7 months), with 75 patients in each group. After 12 months of the first procedure, patients who were converted to sinus rhythm using stepwise ablation showed a significantly lower rate of AF/AT recurrence (26.7%) than did those who were treated using PVI alone (46.7%; P < .001). Similar results were observed in the 52 patients who underwent a second catheter ablation procedure. After adjusting for several potential confounders, the hazard ratio of 12-month AF/AT recurrence after the first ablation procedure was 0.53 (95% confidence interval 0.30-0.91) for those treated using stepwise ablation.
  
  
  CONCLUSIONS
  In addition to PVI, stepwise ablation achieving sinus rhythm and nonatrial arrhythmia inducibility has relevantly improved the clinical outcome of the PAF control strategy.
authors.affiliation: Cardiology Department, Private Hospital "L. Pierangeli," Pescara, Italy; Electrophysiology Operating Unit, Cardiovascular Department, "Spirito Santo" Hospital, ASL Pescara, Pescara, Italy.
authors.forename: Massimiliano
authors.initials: M
authors.lastname: Faustino
authors.affiliation: Department of Specialised, Experimental and Diagnostic Medicine, University of Bologna, Bologna, Italy. Electronic address: carmine.pizzi@unibo.it.
authors.forename: Carmine
authors.initials: C
authors.lastname: Pizzi
authors.affiliation: Electrophysiology Operating Unit, Cardiovascular Department, "Spirito Santo" Hospital, ASL Pescara, Pescara, Italy.
authors.forename: Tullio
authors.initials: T
authors.lastname: Agricola
authors.affiliation: Department of Specialised, Experimental and Diagnostic Medicine, University of Bologna, Bologna, Italy.
authors.forename: Borejda
authors.initials: B
authors.lastname: Xhyheri
authors.affiliation: Department of Specialised, Experimental and Diagnostic Medicine, University of Bologna, Bologna, Italy.
authors.forename: Grazia Maria
authors.initials: GM
authors.lastname: Costa
authors.affiliation: Department of Medicine and Aging Sciences, University of Chieti, Chieti, Italy; Local Health Unit of Pescara, Pescara, Italy.
authors.forename: Maria Elena
authors.initials: ME
authors.lastname: Flacco
authors.affiliation: Department of Medicine and Aging Sciences, University of Chieti, Chieti, Italy; EMISAC, CeSi Biotech, Chieti, Italy.
authors.forename: Lorenzo
authors.initials: L
authors.lastname: Capasso
authors.affiliation: Nursing Department, ASL Lanciano-Vasto-Chieti, Chieti, Italy.
authors.forename: Giancarlo
authors.initials: G
authors.lastname: Cicolini
authors.affiliation: Cardiology Department, ASL Lanciano-Vasto-Chieti, Chieti, Italy.
authors.forename: Enrico
authors.initials: E
authors.lastname: Di Girolamo
authors.affiliation: Cardiology Department, ASL Lanciano-Vasto-Chieti, Chieti, Italy.
authors.forename: Luigi
authors.initials: L
authors.lastname: Leonzio
authors.affiliation: Department of Medicine and Aging Sciences, University of Chieti, Chieti, Italy; EMISAC, CeSi Biotech, Chieti, Italy; Regional Healthcare Agency of Abruzzo, Pescara, Italy; Local Health Unit of Pescara, Pescara, Italy.
authors.forename: Lamberto
authors.initials: L
authors.lastname: Manzoli
mesh_terms: D001281:Atrial Fibrillation / Q000503:physiopathology / Q000601:surgery*; D017115:Catheter Ablation / Q000379:methods*; D022062:Electrophysiologic Techniques, Cardiac; D005260:Female; D006325:Heart Atria / Q000503:physiopathology*; D006329:Heart Conduction System / Q000503:physiopathology / Q000601:surgery*; D006339:Heart Rate / Q000502:physiology*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011667:Pulmonary Veins / Q000601:surgery*; D016037:Single-Blind Method; D016896:Treatment Outcome
keywords: Catheter ablation; Paroxysmal atrial fibrillation; Pulmonary vein isolation; Randomized controlled trial; Stepwise ablation