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Randomized Controlled Trial
. 2019 Jun;30(6):902-909.
doi: 10.1111/jce.13913. Epub 2019 Mar 29.

Optimizing ablation duration using dormant conduction to reveal incomplete isolation with the second generation cryoballoon: A randomized controlled trial

Fehmi Keçe  1 , Marta de Riva  1 , Yoshihisa Naruse  1 , Reza Alizadeh Dehnavi  1 , Adrianus P Wijnmaalen  1 , Martin J Schalij  1 , Katja Zeppenfeld  1 , Serge A Trines  1
Affiliations
Randomized Controlled Trial

Optimizing ablation duration using dormant conduction to reveal incomplete isolation with the second generation cryoballoon: A randomized controlled trial

Fehmi Keçe et al. J Cardiovasc Electrophysiol. 2019 Jun.

Abstract

Introduction: Efficacy of cryoballoon ablation depends on balloon-tissue contact and ablation duration. Prolonged duration may increase extracardiac complications. The aim of this study is to determine the optimal additional ablation duration after acute pulmonary vein isolation (PVI).

Methods: Consecutive patients with paroxysmal AF were randomized to three groups according to additional ablation duration (90, 120, or 150 seconds) after acute PVI (time-to-isolation). Primary outcome was reconnection/dormant conduction (DC) after a 30 minutes waiting period. If present, additional 240 seconds ablations were performed. Ablations without time-to-isolation <90 seconds, esophageal temperature <18°C or decreased phrenic nerve capture were aborted. Patients were followed with 24-hour Holter monitoring at 3, 6, and 12 months.

Results: Seventy-five study patients (60 ± 11 years, 48 male) were included. Reconnection/DC per vein significantly decreased (22%, 6% and 4%) while aborted ablations remained stable (respectively 4, 5, and 7%) among the 90, 120, and 150 seconds groups. A shorter cryo-application time, longer time-to-isolation, higher balloon temperature and unsuccessful ablations predicted reconnection/DC. Freedom of atrial fibrillation was, respectively, 52, 56, and 72% in 90, 120, and 150 seconds groups ( P = 0.27), while repeated procedures significantly decreased from 36% to 4% ( P = 0.041) in the longer duration group compared to shorter duration group (150 seconds vs 90 seconds group). In multivariate Cox-regression only reconnection/DC predicted recurrence.

Conclusion: Prolonging ablation duration after time-to-isolation significantly decreased reconnection/DC and repeated procedures, while recurrences and complications rates were similar. In a time-to-isolation approach, an additional ablation of 150 seconds ablation is the most appropriate.

Keywords: atrial fibrillation; cryoballoon ablation; dormant conduction; pulmonary vein isolation; time-to-isolation.

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Conflict of interest statement

The Heart Lung Center of the Leiden University Medical Center received unrestricted research grants from Medtronic, Biotronik, Boston Scientific, Lantheus medical imaging, St. Jude Medical, Edwards Life sciences & GE Healthcare and unrestricted educational grants from Medtronic, Edwards Life sciences and St. Jude Medical.

Figures

Figure 1
Figure 1
Study protocol. Seventy‐five patients were enrolled and 1:1:1 randomized into three groups of, respectively, 90, 120, and 150 additional ablation time after reaching isolation of the pulmonary vein. Additional ablations were applied in case of reconnection/dormant conduction. Ablations were aborted if no isolation occurred within 90 seconds, in case of reduced phrenic nerve capture or endoluminal esophageal temperature below 18°C
Figure 2
Figure 2
Safety profile of the different ablation groups. One‐year AF‐free survival off antiarrhythmic drugs, percentage of reconnection(RC)/dormant conduction(DC) (per patient), aborted ablations (per patient), phrenic nerve palsy, and repeated procedures across the different groups. There were no significant difference in single‐procedure success off AAD, aborted ablations and phrenic nerve palsy (PNP), however significant differences were seen in the percentage of reconnection/dormant conduction (P < 0.001) and repeated procedures (P = 0.041). PNP, phrenic nerve palsy; RC/DC, reconnection and dormant conduction; TTI, time‐to‐isolation
See this image and copyright information in PMC

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