Initial rhythm control with cryoballoon ablation vs drug therapy: Impact on quality of life and symptoms

• Published in: American Heart Journal
• Main Authors: 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
• Other Authors: 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
• Language: English
• Published: HAL CCSD 2021
• Subjects: [SDV]Life Sciences [q-bio]; [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology; Arctic; Human health
• Online Access: https://u-picardie.hal.science/hal-03572217; https://doi.org/10.1016/j.ahj.2021.08.007

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.