CLINICAL RESEARCH: HEART RHYTHM DISORDER
Circumferential Pulmonary Vein Isolation With the Cryoballoon TechniqueResults From a Prospective 3-Center Study
Thomas Neumann, MD*,*,
Jürgen Vogt, MD ,
Burghard Schumacher, MD ,
Anja Dorszewski, MD ,
Malte Kuniss, MD*,
Hans Neuser, MD ,
Klaus Kurzidim, MD*,
Alexander Berkowitsch, PhD*,
Marcus Koller, MD ,
Johannes Heintze, MD ,
Ursula Scholz, MD ,
Ulrike Wetzel, MD ,
Michael A.E. Schneider, MD ,
Dieter Horstkotte, MD, PhD, FESC, FACC ,
Christian W. Hamm, MD, FESC* and
Heinz-Friedrich Pitschner, MD, FESC*
* Department of Cardiology, Kerckhoff Heart Center, Bad Nauheim, Germany
Department of Cardiology, Heart and Diabetes Center North Rhine-Westphalia, Ruhr University Bochum, Bad Oeynhausen, Germany
Department of Cardiology, Center of Cardiovascular Medicine, Bad Neustadt/Saale, Germany.
Manuscript received January 15, 2008;
revised manuscript received March 12, 2008,
accepted April 3, 2008.
* Reprint requests and correspondence: Dr. Thomas Neumann, Department of Cardiology, Kerckhoff Heart Center, Benekestr. 2-8, 61231 Bad Nauheim, Germany. (Email: t.neumann{at}kerckhoff-klinik.de).
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
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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 |
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