Clinical Research
Heart Rhythm Disorder
Circumferential Pulmonary Vein Isolation With the Cryoballoon Technique: Results From a Prospective 3-Center Study

https://doi.org/10.1016/j.jacc.2008.04.021Get rights and content
Under an Elsevier user license
open archive

Objectives

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.

Key Words

ablation
arrhythmia
cryoballoon
catheter ablation
tachyarrhythmias
atrial fibrillation
pulmonary veins

Abbreviations and Acronyms

AF
atrial fibrillation
LA
left atrium/atrial
MRI
magnetic resonance imaging
PAF
paroxysmal atrial fibrillation
PNP
phrenic nerve palsy
PV
pulmonary vein
PVI
pulmonary vein isolation

Cited by (0)

Dr. Vogt has received speakers' honoraria and honoraria for advisory board meetings from Cryocath; Dr. Schumacher has been on the Speakers' Bureau of Cryocath; Dr. Kuniss has received speakers' honoraria from Cryocath; Dr. Heintze has received honoraria for cryo training from Cryocath; and Dr. Pitschner has received honoraria for advisory board meetings from Cryocath.