title: Circumferential pulmonary vein isolation with the cryoballoon technique results from a prospective 3-center study.
abstract: OBJECTIVE
  The purpose of this study was to investigate the efficacy safety of the novel cryoballoon device (Arctic Front, Cryocath, Quebec, Canada).
  
  
  BACKGROUND
  Antral pulmonary vein (PV) ablation with radiofrequency energy is widely used as a strategy for catheter ablation of paroxysmal atrial fibrillation (PAF). A novel double lumen cryoballoon catheter was designed for circumferential pulmonary vein isolation (PVI) with the cryoablation technique.
  
  
  METHODS
  We consecutively enrolled 346 patients with symptomatic, drug refractory paroxysmal (n = 293) or persistent (n = 53) atrial fibrillation (AF). In all patients, PVI of all targeted PVs was the therapeutic aim. The primary end points of this nonrandomized study were: 1) acute isolation rate of targeted PV; and 2) first electrocardiogram-documented recurrence of AF. The secondary end point was occurrence of PV stenosis or atrio-esophageal fistula.
  
  
  RESULTS
  The 1,360 of 1,403 PVs (97%) were targeted with balloons or balloons in combination with the use of Freezor Max (Cryocath). We found that ablation with the cryoballoon resulted in maintenance of sinus rhythm in 74% of patients with PAF and 42% of patients with persistent AF. No PV narrowing occurred. The most frequent complication was right phrenic nerve palsy observed during cryoballoon ablation at the right superior PV.
  
  
  CONCLUSIONS
  Pulmonary vein isolation with a new cryoballoon technique is feasible. Sinus rhythm can be maintained in the majority of patients with PAF by circumferential PVI using a cryoballoon ablation system. Cryoablation was less effective in patients with persistent AF than in patients with PAF.
authors.affiliation: Department of Cardiology, Kerckhoff Heart Center, Bad Nauheim, Germany. t.neumann@kerckhoff-klinik.de
authors.forename: Thomas
authors.initials: T
authors.lastname: Neumann
authors.forename: Jürgen
authors.initials: J
authors.lastname: Vogt
authors.forename: Burghard
authors.initials: B
authors.lastname: Schumacher
authors.forename: Anja
authors.initials: A
authors.lastname: Dorszewski
authors.forename: Malte
authors.initials: M
authors.lastname: Kuniss
authors.forename: Hans
authors.initials: H
authors.lastname: Neuser
authors.forename: Klaus
authors.initials: K
authors.lastname: Kurzidim
authors.forename: Alexander
authors.initials: A
authors.lastname: Berkowitsch
authors.forename: Marcus
authors.initials: M
authors.lastname: Koller
authors.forename: Johannes
authors.initials: J
authors.lastname: Heintze
authors.forename: Ursula
authors.initials: U
authors.lastname: Scholz
authors.forename: Ulrike
authors.initials: U
authors.lastname: Wetzel
authors.forename: Michael A E
authors.initials: MA
authors.lastname: Schneider
authors.forename: Dieter
authors.initials: D
authors.lastname: Horstkotte
authors.forename: Christian W
authors.initials: CW
authors.lastname: Hamm
authors.forename: Heinz-Friedrich
authors.initials: HF
authors.lastname: Pitschner
mesh_terms: D000368:Aged; D000800:Angioplasty, Balloon / Q000295:instrumentation / Q000379:methods*; D001281:Atrial Fibrillation / Q000503:physiopathology / Q000628:therapy*; D017679:Cryotherapy; D022062:Electrophysiologic Techniques, Cardiac; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011667:Pulmonary Veins; D013997:Time Factors; D016896:Treatment Outcome