Initial rhythm control with cryoballoon ablation vs drug therapy: Impact on quality of life and symptoms
International audience Background Cryoballoon ablation (CBA) as a first-line rhythm control strategy is superior to antiarrhythmic drugs (AADs) for preventing atrial fibrillation (AF) recurrence; the impact of first-line CBA on quality of life (QoL) and symptoms has not been well characterized. Meth...
Published in: | American Heart Journal |
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Main Authors: | , , , , , , , , , , , , , , , , , , |
Other Authors: | , , , , , , , , , , , , , , , , , , , , , , , , |
Format: | Article in Journal/Newspaper |
Language: | English |
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HAL CCSD
2021
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Online Access: | https://u-picardie.hal.science/hal-03572217 https://doi.org/10.1016/j.ahj.2021.08.007 |
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English |
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[SDV]Life Sciences [q-bio] [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology |
spellingShingle |
[SDV]Life Sciences [q-bio] [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology Pavlovic, Nikola Chierchia, Gian-Battista Velagic, Vedran Hermida, Jean Sylvain Healey, Stewart Arena, Giuseppe Badenco, Nicolas Meyer, Christian Chen, Jian Iacopino, Saverio Anselme, Frédéric Dekker, Lukas Scazzuso, Fernando Packer, Douglas L. Asmundis, Carlo, De Pitschner, Heinz-Friedrich Di Piazza, Fabio Kaplon, Rachelle E. Kuniss, Malte Initial rhythm control with cryoballoon ablation vs drug therapy: Impact on quality of life and symptoms |
topic_facet |
[SDV]Life Sciences [q-bio] [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology |
description |
International audience Background Cryoballoon ablation (CBA) as a first-line rhythm control strategy is superior to antiarrhythmic drugs (AADs) for preventing atrial fibrillation (AF) recurrence; the impact of first-line CBA on quality of life (QoL) and symptoms has not been well characterized. Methods Patients aged 18 to 75 with symptomatic paroxysmal AF naive to rhythm control therapy were randomized (1:1) to CBA (Arctic Front Advance, Medtronic) or AAD (Class I or III). Symptoms and QoL were assessed at baseline, 1, 3, 6, 9, and 12 months using the EHRA classification and Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) and SF-36v2 questionnaires. Symptomatic palpitations were evaluated via patient diary. Results Overall, 107 patients were randomized to CBA and 111 to AAD; crossovers occurred in 9%. Larger improvements in the AFEQT summary, subscale and treatment satisfaction scores were observed at 12 months with CBA vs AAD (all P < 0.05). At 12 months, the mean adjusted difference in the AFEQT summary score was 9.9 points higher in the CBA group (95% CI: 5.5 -14.2, P < 0.001). Clinically important improvements in the SF-36 physical and mental component scores were observed at 12 months in both groups, with no significant between group differences at this timepoint. In the CBA vs AAD group, larger improvements in EHRA class were observed at 6, 9 and 12 months ( P < 0.05) and the incidence rate of symptomatic palpitations was lower (4.6 vs 15.2 days/year post-blanking; IRR: 0.30, P < 0.001). Conclusions In patients with symptomatic AF, first-line CBA was superior to AAD for improving AF-specific QoL and symptoms. Trial registration ClinicalTrials.gov number: NCT01803438. |
author2 |
University Hospital Sestre Milosrdnice Vrije Universiteit Brussel Bruxelles (VUB) University Hospital Centre Zagreb Partenaires INRAE CHU Amiens-Picardie Mécanismes physiopathologiques et conséquences des calcifications vasculaires - UR UPJV 7517 (MP3CV) Université de Picardie Jules Verne (UPJV)-CHU Amiens-Picardie Monash Health and Hudson Institute University of Luxembourg Luxembourg Institut de cardiologie CHU Pitié-Salpêtrière CHU Pitié-Salpêtrière AP-HP Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU) Institut Jean-Pierre Bourgin (IJPB) AgroParisTech-Université Paris-Saclay-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE) Ohio State University Columbus (OSU) Maria Cecilia Hospital CHU Rouen Normandie Université (NU) Eindhoven University of Technology Eindhoven (TU/e) Catharina Hospital ECLAEstudios Clínicos Latino América & Instituto Cardiovascular de Rosario), Rosario, Argentina St Marys' Hospital Campus Kerckhoff-Klinik Medtronic Inc Minneapolis, MI, USA Medtronic |
format |
Article in Journal/Newspaper |
author |
Pavlovic, Nikola Chierchia, Gian-Battista Velagic, Vedran Hermida, Jean Sylvain Healey, Stewart Arena, Giuseppe Badenco, Nicolas Meyer, Christian Chen, Jian Iacopino, Saverio Anselme, Frédéric Dekker, Lukas Scazzuso, Fernando Packer, Douglas L. Asmundis, Carlo, De Pitschner, Heinz-Friedrich Di Piazza, Fabio Kaplon, Rachelle E. Kuniss, Malte |
author_facet |
Pavlovic, Nikola Chierchia, Gian-Battista Velagic, Vedran Hermida, Jean Sylvain Healey, Stewart Arena, Giuseppe Badenco, Nicolas Meyer, Christian Chen, Jian Iacopino, Saverio Anselme, Frédéric Dekker, Lukas Scazzuso, Fernando Packer, Douglas L. Asmundis, Carlo, De Pitschner, Heinz-Friedrich Di Piazza, Fabio Kaplon, Rachelle E. Kuniss, Malte |
author_sort |
Pavlovic, Nikola |
title |
Initial rhythm control with cryoballoon ablation vs drug therapy: Impact on quality of life and symptoms |
title_short |
Initial rhythm control with cryoballoon ablation vs drug therapy: Impact on quality of life and symptoms |
title_full |
Initial rhythm control with cryoballoon ablation vs drug therapy: Impact on quality of life and symptoms |
title_fullStr |
Initial rhythm control with cryoballoon ablation vs drug therapy: Impact on quality of life and symptoms |
title_full_unstemmed |
Initial rhythm control with cryoballoon ablation vs drug therapy: Impact on quality of life and symptoms |
title_sort |
initial rhythm control with cryoballoon ablation vs drug therapy: impact on quality of life and symptoms |
publisher |
HAL CCSD |
publishDate |
2021 |
url |
https://u-picardie.hal.science/hal-03572217 https://doi.org/10.1016/j.ahj.2021.08.007 |
geographic |
Arctic |
geographic_facet |
Arctic |
genre |
Arctic Human health |
genre_facet |
Arctic Human health |
op_source |
ISSN: 0002-8703 EISSN: 1097-6744 American Heart Journal https://u-picardie.hal.science/hal-03572217 American Heart Journal, 2021, 242, pp.103-114. ⟨10.1016/j.ahj.2021.08.007⟩ |
op_relation |
info:eu-repo/semantics/altIdentifier/doi/10.1016/j.ahj.2021.08.007 info:eu-repo/semantics/altIdentifier/pmid/34508694 hal-03572217 https://u-picardie.hal.science/hal-03572217 doi:10.1016/j.ahj.2021.08.007 PUBMED: 34508694 WOS: 000706967000002 |
op_rights |
http://creativecommons.org/licenses/by-nc-nd/ |
op_doi |
https://doi.org/10.1016/j.ahj.2021.08.007 |
container_title |
American Heart Journal |
container_volume |
242 |
container_start_page |
103 |
op_container_end_page |
114 |
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1802641617983635456 |
spelling |
ftnormandieuniv:oai:HAL:hal-03572217v1 2024-06-23T07:50:42+00:00 Initial rhythm control with cryoballoon ablation vs drug therapy: Impact on quality of life and symptoms Pavlovic, Nikola Chierchia, Gian-Battista Velagic, Vedran Hermida, Jean Sylvain Healey, Stewart Arena, Giuseppe Badenco, Nicolas Meyer, Christian Chen, Jian Iacopino, Saverio Anselme, Frédéric Dekker, Lukas Scazzuso, Fernando Packer, Douglas L. Asmundis, Carlo, De Pitschner, Heinz-Friedrich Di Piazza, Fabio Kaplon, Rachelle E. Kuniss, Malte University Hospital Sestre Milosrdnice Vrije Universiteit Brussel Bruxelles (VUB) University Hospital Centre Zagreb Partenaires INRAE CHU Amiens-Picardie Mécanismes physiopathologiques et conséquences des calcifications vasculaires - UR UPJV 7517 (MP3CV) Université de Picardie Jules Verne (UPJV)-CHU Amiens-Picardie Monash Health and Hudson Institute University of Luxembourg Luxembourg Institut de cardiologie CHU Pitié-Salpêtrière CHU Pitié-Salpêtrière AP-HP Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU) Institut Jean-Pierre Bourgin (IJPB) AgroParisTech-Université Paris-Saclay-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE) Ohio State University Columbus (OSU) Maria Cecilia Hospital CHU Rouen Normandie Université (NU) Eindhoven University of Technology Eindhoven (TU/e) Catharina Hospital ECLAEstudios Clínicos Latino América & Instituto Cardiovascular de Rosario), Rosario, Argentina St Marys' Hospital Campus Kerckhoff-Klinik Medtronic Inc Minneapolis, MI, USA Medtronic 2021 https://u-picardie.hal.science/hal-03572217 https://doi.org/10.1016/j.ahj.2021.08.007 en eng HAL CCSD Elsevier info:eu-repo/semantics/altIdentifier/doi/10.1016/j.ahj.2021.08.007 info:eu-repo/semantics/altIdentifier/pmid/34508694 hal-03572217 https://u-picardie.hal.science/hal-03572217 doi:10.1016/j.ahj.2021.08.007 PUBMED: 34508694 WOS: 000706967000002 http://creativecommons.org/licenses/by-nc-nd/ ISSN: 0002-8703 EISSN: 1097-6744 American Heart Journal https://u-picardie.hal.science/hal-03572217 American Heart Journal, 2021, 242, pp.103-114. ⟨10.1016/j.ahj.2021.08.007⟩ [SDV]Life Sciences [q-bio] [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology info:eu-repo/semantics/article Journal articles 2021 ftnormandieuniv https://doi.org/10.1016/j.ahj.2021.08.007 2024-06-04T00:03:24Z International audience Background Cryoballoon ablation (CBA) as a first-line rhythm control strategy is superior to antiarrhythmic drugs (AADs) for preventing atrial fibrillation (AF) recurrence; the impact of first-line CBA on quality of life (QoL) and symptoms has not been well characterized. Methods Patients aged 18 to 75 with symptomatic paroxysmal AF naive to rhythm control therapy were randomized (1:1) to CBA (Arctic Front Advance, Medtronic) or AAD (Class I or III). Symptoms and QoL were assessed at baseline, 1, 3, 6, 9, and 12 months using the EHRA classification and Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) and SF-36v2 questionnaires. Symptomatic palpitations were evaluated via patient diary. Results Overall, 107 patients were randomized to CBA and 111 to AAD; crossovers occurred in 9%. Larger improvements in the AFEQT summary, subscale and treatment satisfaction scores were observed at 12 months with CBA vs AAD (all P < 0.05). At 12 months, the mean adjusted difference in the AFEQT summary score was 9.9 points higher in the CBA group (95% CI: 5.5 -14.2, P < 0.001). Clinically important improvements in the SF-36 physical and mental component scores were observed at 12 months in both groups, with no significant between group differences at this timepoint. In the CBA vs AAD group, larger improvements in EHRA class were observed at 6, 9 and 12 months ( P < 0.05) and the incidence rate of symptomatic palpitations was lower (4.6 vs 15.2 days/year post-blanking; IRR: 0.30, P < 0.001). Conclusions In patients with symptomatic AF, first-line CBA was superior to AAD for improving AF-specific QoL and symptoms. Trial registration ClinicalTrials.gov number: NCT01803438. Article in Journal/Newspaper Arctic Human health Normandie Université: HAL Arctic American Heart Journal 242 103 114 |