Florian Straube1, Uwe Dorwarth2, Sonia Ammar-Busch3, Timo Peter4, Georg Noelker5, Thomas Massa6, Malte Kuniss7, Niels Christian Ewertsen8, Kyoung Ryul Julian Chun9, Juergen Tebbenjohanns10, Roland Tilz11, Karl Heinz Kuck11, Taoufik Ouarrak12, Jochen Senges12, 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@web.de 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 Electrophysiology, Deutsches Herzzentrum München, Technische Universität München, Munich, Germany. 4. KRH Klinikum Siloah-Oststadt-Heidehaus, Hannover, Germany. 5. Department of Cardiology, Heart and Diabetes Center North Rhine-Westphalia, Ruhr University Bochum, Bad Oeynhausen, Germany. 6. Klinikum Frankfurt Höchst GmbH, Frankfurt Main, Germany. 7. Kerckhoff-Klinik GmbH, Bad Nauheim, Germany. 8. Vivantes Klinikum Am Urban, Berlin, Germany. 9. Cardioangiologisches Centrum Bethanien, CCB, Frankfurt a.M., Germany. 10. Helios Klinikum Hildesheim, Hildesheim, Germany. 11. Asklepios St Georg Hospital, Hamburg, Germany. 12. Stiftung Institut fuer Herzinfarktforschung, IHF Foundation, Ludwigshafen, Germany.
Abstract
AIMS: First-line ablation prior to antiarrhythmic drug (AAD) therapy is an option for symptomatic paroxysmal atrial fibrillation (PAF); however, the optimal ablation technique, radiofrequency (RF), or cryoballoon (CB) has to be determined. METHODS AND RESULTS: The FREEZE Cohort Study compares RF and CB ablation. Treatment-naïve patients were documented in the FREEZEplus Registry. Periprocedural data and outcome were analysed. From 2011 to 2014, a total of 373/4184 (8.9%) patients with PAF naïve to AAD were identified. Pulmonary vein isolation (PVI) was performed with RF (n = 180) or CB (n = 193). In the RF group, patients were older (65 vs. 61 years, P < 0.01) compared with the CB group. The procedure time was significantly shorter and radiation exposure higher in the CB group. Major adverse events occurred in 1.6% (CB) and 3.7% (RF) of patients (P = 0.22). AF/atrial tachycardia (AT) recurrence until discharge was 4.5% (RF) and 8.5% (CB, P = 0.2). Follow-up (FU) ≥12 months was available in 99 (RF) and 107 (CB) patients. After 1.4 years of FU, freedom from AF/atrial tachycardia (AT) was 61% (RF) and 71% (CB, P = 0.11). In the RF group, more patients underwent cardioversion, and a trend for more repeat ablations was observed. Persistent phrenic nerve palsy was observed in one patient treated by CB. CONCLUSION: First-line ablation for PAF is safe and effective with either RF or CB. The procedure was faster with the CB, but the radiation exposure was higher. Although there was a trend for more recurrences and complications in the RF group, a more favourable risk profile in patients undergoing CB ablation might have biased the results. CLINICALTRIALSGOV IDENTIFIER: NCT01360008. Published on behalf of the European Society of Cardiology. All rights reserved.
AIMS: First-line ablation prior to antiarrhythmic drug (AAD) therapy is an option for symptomatic paroxysmal atrial fibrillation (PAF); however, the optimal ablation technique, radiofrequency (RF), or cryoballoon (CB) has to be determined. METHODS AND RESULTS: The FREEZE Cohort Study compares RF and CB ablation. Treatment-naïve patients were documented in the FREEZEplus Registry. Periprocedural data and outcome were analysed. From 2011 to 2014, a total of 373/4184 (8.9%) patients with PAF naïve to AAD were identified. Pulmonary vein isolation (PVI) was performed with RF (n = 180) or CB (n = 193). In the RF group, patients were older (65 vs. 61 years, P < 0.01) compared with the CB group. The procedure time was significantly shorter and radiation exposure higher in the CB group. Major adverse events occurred in 1.6% (CB) and 3.7% (RF) of patients (P = 0.22). AF/atrial tachycardia (AT) recurrence until discharge was 4.5% (RF) and 8.5% (CB, P = 0.2). Follow-up (FU) ≥12 months was available in 99 (RF) and 107 (CB) patients. After 1.4 years of FU, freedom from AF/atrial tachycardia (AT) was 61% (RF) and 71% (CB, P = 0.11). In the RF group, more patients underwent cardioversion, and a trend for more repeat ablations was observed. Persistent phrenic nerve palsy was observed in one patient treated by CB. CONCLUSION: First-line ablation for PAF is safe and effective with either RF or CB. The procedure was faster with the CB, but the radiation exposure was higher. Although there was a trend for more recurrences and complications in the RF group, a more favourable risk profile in patients undergoing CB ablation might have biased the results. CLINICALTRIALSGOV IDENTIFIER: NCT01360008. Published on behalf of the European Society of Cardiology. All rights reserved.
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