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Clinical Trial
. 2008 Nov;10(11):1271-6.
doi: 10.1093/europace/eun218.

One year follow-up after cryoballoon isolation of the pulmonary veins in patients with paroxysmal atrial fibrillation

Yves Van Belle  1 , Petter Janse, Dominic Theuns, Tamas Szili-Torok, Luc Jordaens
Affiliations
Clinical Trial

One year follow-up after cryoballoon isolation of the pulmonary veins in patients with paroxysmal atrial fibrillation

Yves Van Belle et al. Europace. 2008 Nov.

Abstract

Aims: Pulmonary vein isolation (PVI) with cryoenergy delivered through a balloon is a new approach in the treatment of atrial fibrillation (AF), but long-term follow-up is lacking. The aim of this study was to provide insight in the success rate and the incidence of recurrences.

Methods and results: Patients with symptomatic AF despite anti-arrhythmic drugs (AADs) were treated with cryoballoon PVI. Daily transtelephonic ECG monitoring, 24 h Holter-ECG, and an arrhythmia-focused questionnaire were used to document AF. One hundred and forty-one patients completed a follow-up of 457 +/- 252 days. Before ablation, Holter-ECG showed AF in 45%, including 16% continuous AF throughout the recording. Event recording revealed a median AF burden of 26%. The questionnaire showed a median of weekly AF complaints lasting for hours. All but one patient had successful PVI with a single procedure. After ablation, AF (defined as lasting for more than 30 s) was seen in 11% of Holter-ECGs, with 1% continuous AF. The event recording showed an AF burden of 9%. The median patient reported no more AF-related symptoms. Recurrence during the first 3 months was predictive for later recurrence. A second procedure was performed in 24 patients. The freedom of AF was 59% without AADs after 1,2 procedures. Four right phrenic nerve paralyses occurred, all resolving within 6 months. No PV stenoses were observed.

Conclusion: Pulmonary vein isolation with a cryothermal balloon is an effective treatment for paroxysmal AF, resulting in a clinical success rate comparable to studies involving radiofrequency ablation. Temporary right phrenic nerve paralysis is the most important complication.

Keywords: Ablation; Atrial fibrillation; Cryoablation; Cryoballoon; Follow-up.

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Figures

Figure 1
Figure 1
Atrial fibrillation (AF) burden as calculated from transtelephonic ECG recordings sorted ascendingly by the burden before pulmonary vein isolation (before) and burden sorted ascendingly after isolation (after). The area between both curves represents the reduction in AF burden for the entire group.
Figure 2
Figure 2
Event-free survival curve for atrial fibrillation (AF) after a single ablation procedure. The two curves represent the same patient population. The upper curve (AF only after 3 months) represents the event-free survival after a 3-month blanking period; the second curve (All AF) represents the event-free survival without the 3-month blanking period. The patient numbers of both groups are represented at the bottom.
Figure 3
Figure 3
Event-free survival curve for atrial fibrillation (AF) after a single ablation procedure, employing 3-month blanking period. The upper curve (no early recurrence) is the patient population that did not have recurrence of AF during the blanking period. The lower curve (with early recurrence) represents the group that experienced recurrence of AF during the 3-month blanking period. Patient numbers of both groups are represented at the bottom.
Figure 4
Figure 4
Graphical representation of the overall 1-year clinical outcome after a mean of 1,2 procedures, presented as patient numbers. AF, recurrence of atrial fibrillation; AAD, anti-arrhythmic drugs.
See this image and copyright information in PMC

Comment in

References

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