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CLINICAL RESEARCH: HEART RHYTHM DISORDER

Circumferential Pulmonary Vein Isolation With the Cryoballoon Technique

Results 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

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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