title: Pulmonary Vein Isolation Using a Second-Generation Cryoballoon in Patients With Paroxysmal Atrial Fibrillation: One-Year Outcome Using a Single Big-Balloon 3-Minute Freeze Technique.
abstract: The second-generation cryoballoon (CB) has been recently introduced into clinical use for pulmonary vein isolation (PVI). Data on the feasibility, long-term outcome, and optimal freeze cycle are still limited. We assessed the 1-year clinical outcome after second-generation CB ablation with single 3-minute freeze techniques, and clinical variables associated with AF recurrence.
  
  
  
  A total of 108 paroxysmal atrial fibrillation (PAF) patients undergoing cryothermal PVI were enrolled. PVI was performed with one 28-mm CB using single 3-minute freeze techniques without bonus applications. Fourteen-day consecutive monitoring was done after discharge to detect early AF recurrences (ERAFs).
  
  
  
  Out of 425 PVs, 409 (96.2%) were isolated using exclusively CBs, and 16 required touch-up ablation. Transient phrenic nerve injury, pericardial tamponade, and 50% PV stenosis occurred in 9, 1, and 1 patients, respectively. No PV stenosis >50% was observed in any patients. The total procedure and fluoroscopic times were 82.9 ± 26.4 and 26.2 ± 14.8 minutes, respectively. ERAFs were detected in 51 (47.2%) patients. At 1-year after single and repeat procedures, 71.6% and 84.3% of the patients were free from recurrent AF off antiarrhythmic drugs (AADs), respectively. Eighteen patients underwent repeat procedures (median 6.0 [4.0-9.3] months post procedure), and 68.6% of PVs were still isolated. Cox's proportional models determined that ERAFs were significantly associated with AF recurrence (HR = 7.236; 95%CI = 2.753-19.016; P < 0.0001). AF-freedom off AADs at 1-year after single procedures was 90.8% and 50.3% in patients without and with ERAFs.
  
  
  
  Second-generation CB ablation using single 3-minute freeze techniques appears feasible in PAF patients. ERAFs were significant factors for predicting clinical outcomes.
authors.affiliation: Cardiology Division, Cardiovascular Center, Tsuchiura Kyodo Hospital, Tsuchiura, Ibaraki, Japan.
authors.forename: Shinsuke
authors.initials: S
authors.lastname: Miyazaki
authors.affiliation: Cardiology Division, Cardiovascular Center, Tsuchiura Kyodo Hospital, Tsuchiura, Ibaraki, Japan.
authors.forename: Hitoshi
authors.initials: H
authors.lastname: Hachiya
authors.affiliation: Cardiology Division, Cardiovascular Center, Tsuchiura Kyodo Hospital, Tsuchiura, Ibaraki, Japan.
authors.forename: Hiroaki
authors.initials: H
authors.lastname: Nakamura
authors.affiliation: Cardiology Division, Cardiovascular Center, Tsuchiura Kyodo Hospital, Tsuchiura, Ibaraki, Japan.
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Taniguchi
authors.affiliation: Cardiology Division, Cardiovascular Center, Tsuchiura Kyodo Hospital, Tsuchiura, Ibaraki, Japan.
authors.forename: Takamitsu
authors.initials: T
authors.lastname: Takagi
authors.affiliation: Heart Rhythm Center, Tokyo Medical and Dental University, Tokyo, Japan.
authors.forename: Kenzo
authors.initials: K
authors.lastname: Hirao
authors.affiliation: Cardiology Division, Cardiovascular Center, Tsuchiura Kyodo Hospital, Tsuchiura, Ibaraki, Japan.
authors.forename: Yoshito
authors.initials: Y
authors.lastname: Iesaka
mesh_terms: D000368:Aged; D000889:Anti-Arrhythmia Agents / Q000627:therapeutic use; D001281:Atrial Fibrillation / Q000175:diagnosis / Q000503:physiopathology / Q000601:surgery*; D003452:Cryosurgery / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods; D018572:Disease-Free Survival; D004867:Equipment Design; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000209:etiology / Q000601:surgery; D016016:Proportional Hazards Models; D011667:Pulmonary Veins / Q000503:physiopathology / Q000601:surgery*; D012008:Recurrence; D012086:Reoperation; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000889:Anti-Arrhythmia Agents
keywords: atrial fibrillation; catheter ablation; cryoballoon; phrenic nerve paralysis; pulmonary vein isolation