TY - JOUR
T1 - Initial rhythm control with cryoballoon ablation vs drug therapy
T2 - Impact on quality of life and symptoms
AU - Cryo-FIRST Investigators
AU - Pavlovic, Nikola
AU - Chierchia, Gian Battista
AU - Velagic, Vedran
AU - Hermida, Jean Sylvain
AU - Healey, Stewart
AU - Arena, Giuseppe
AU - Badenco, Nicolas
AU - Meyer, Christian
AU - Chen, Jian
AU - Iacopino, Saverio
AU - Anselme, Frédéric
AU - Dekker, Lukas
AU - Scazzuso, Fernando
AU - Packer, Douglas L.
AU - de Asmundis, Carlo
AU - Pitschner, Heinz Friedrich
AU - Piazza, Fabio Di
AU - Kaplon, Rachelle E.
AU - Kuniss, Malte
N1 - Publisher Copyright:
© 2021
PY - 2021/12
Y1 - 2021/12
N2 - 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 naïve 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.
AB - 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 naïve 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.
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U2 - 10.1016/j.ahj.2021.08.007
DO - 10.1016/j.ahj.2021.08.007
M3 - Article
C2 - 34508694
AN - SCOPUS:85121477269
SN - 0002-8703
VL - 242
SP - 103
EP - 114
JO - American heart journal
JF - American heart journal
ER -