Florian Straube1, Uwe Dorwarth2, Juergen Vogt3, Malte Kuniss4, Karl Heinz Kuck5, Juergen Tebbenjohanns6, Arcadi Garcia Alberola7, Kyoung Ryul Julian Chun8, Joseph J Souza9, Taoufik Ouarrak10, Jochen Senges10, Johannes Brachmann11, Thorsten Lewalter12, Ellen Hoffmann2. 1. Department of Cardiology and Internal Intensive Care Medicine, Heart Center Munich-Bogenhausen, Munich Municipal Hospital Group, Englschalkinger Str. 77, 81925 Munich, Germany florian.straube@klinikum-muenchen.de. 2. Department of Cardiology and Internal Intensive Care Medicine, Heart Center Munich-Bogenhausen, Munich Municipal Hospital Group, Englschalkinger Str. 77, 81925 Munich, Germany. 3. Department of Cardiology, Heart and Diabetes Center North Rhine-Westphalia, Ruhr University Bochum, 32545 Bad Oeynhausen, Germany. 4. Kerckhoff-Klinik GmbH, Department of Cardiology, 61231 Bad Nauheim, Germany. 5. Asklepios St Georg Hospital, Department of Cardiology, 20009 Hamburg, Germany. 6. Klinikum Hildesheim, Department of Cardiology, 31115 Hildesheim, Germany. 7. University Hospital Virgen de la Arrixaca, Department of Cardiology, 30120 El Palmar, Murcia, Spain. 8. Cardioangiologisches Centrum Bethanien, CCB, Department of Cardiology, 60431 Frankfurt a.M., Germany. 9. Mission Hospital, Inc., Department of Cardiology, 28801 Asheville, NC, USA. 10. Institut fuer Herzinfarktforschung, IHF Foundation, 67063 Ludwigshafen, Germany. 11. Klinikum Coburg, Department of Cardiology, 96450 Coburg, Germany. 12. Department of Cardiology, Isar Herz Center Munich, Munich, Germany.
Abstract
AIMS: Cryoballoon (CB) ablation with the second-generation cryoballoon (CBG2) seems to be more effective than its predecessor [first-generation cryoballoon (CBG1)], but phrenic nerve palsies were observed more frequently. The aim of this study was to compare the safety and efficacy of CBG1 and CBG2 in a substudy of the prospective multicentre, multinational FREEZE Cohort Study. METHODS AND RESULTS: Periprocedural data were analysed, and a total of 532 patients with paroxysmal atrial fibrillation (AF) were examined (n = 224 for CBG1 and n = 308 for CBG2). Procedure time decreased significantly from 149 to 130 min when comparing CBG1 with CBG2 (P < 0.0001), and pulmonary vein isolation (PVI) was achieved in 97.8 and 97.6% of PVs with CBG1 and CBG2 (P = 0.77), respectively. The need for dual-balloon usage within a procedure dropped (20.1 vs. 9.0%, P < 0.001), and the fluoroscopy time was reduced when operating the CBG2. Atrial fibrillation recurrence rates until discharge were similar (5.0 vs. 5.8%, P = 0.69). Comparable low rates of major complications were observed with both CBs, and there was a non-significant trend for more phrenic nerve palsies. CONCLUSION: Second-generation cryoballoon demonstrated a high rate of acute PVI in a significant faster procedure, which also utilized less radiation exposure and less dual-balloon usage during an average procedure. The safety profile remains favourable with a non-significant trend for more phrenic nerve palsies. If the enhancements lead to a higher clinical benefit has to be determined. The 1-year outcome data from the ongoing FREEZE Cohort Study comparing radiofrequency and CB ablation will shed some light on that issue. CLINICAL TRIALS GOV IDENTIFIER: NCT01360008. Published on behalf of the European Society of Cardiology. All rights reserved.
AIMS: Cryoballoon (CB) ablation with the second-generation cryoballoon (CBG2) seems to be more effective than its predecessor [first-generation cryoballoon (CBG1)], but phrenic nerve palsies were observed more frequently. The aim of this study was to compare the safety and efficacy of CBG1 and CBG2 in a substudy of the prospective multicentre, multinational FREEZE Cohort Study. METHODS AND RESULTS: Periprocedural data were analysed, and a total of 532 patients with paroxysmal atrial fibrillation (AF) were examined (n = 224 for CBG1 and n = 308 for CBG2). Procedure time decreased significantly from 149 to 130 min when comparing CBG1 with CBG2 (P < 0.0001), and pulmonary vein isolation (PVI) was achieved in 97.8 and 97.6% of PVs with CBG1 and CBG2 (P = 0.77), respectively. The need for dual-balloon usage within a procedure dropped (20.1 vs. 9.0%, P < 0.001), and the fluoroscopy time was reduced when operating the CBG2. Atrial fibrillation recurrence rates until discharge were similar (5.0 vs. 5.8%, P = 0.69). Comparable low rates of major complications were observed with both CBs, and there was a non-significant trend for more phrenic nerve palsies. CONCLUSION: Second-generation cryoballoon demonstrated a high rate of acute PVI in a significant faster procedure, which also utilized less radiation exposure and less dual-balloon usage during an average procedure. The safety profile remains favourable with a non-significant trend for more phrenic nerve palsies. If the enhancements lead to a higher clinical benefit has to be determined. The 1-year outcome data from the ongoing FREEZE Cohort Study comparing radiofrequency and CB ablation will shed some light on that issue. CLINICAL TRIALS GOV IDENTIFIER: NCT01360008. Published on behalf of the European Society of Cardiology. All rights reserved.
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