Abstract 196 Quality of life and symptoms during initial rhythm control therapy for Atrial Fibrillation in the Cryo-FIRST study: A comparison between cryoballoon ablation versus antiarrhythmic drug therapy

BACKGROUND

Following clinical guidelines, catheter ablation is a recommended treatment for patients with symptomatic drug-refractory paroxysmal atrial fibrillation (AF), as patients try to alleviate AF symptoms that reduce Quality of Life (QoL). Ablation as a first-line rhythm control strategy is superior to antiarrhythmic drugs (AADs) for preventing atrial fibrillation (AF) recurrence; the impact of first-line ablation on quality of life (QoL) and symptoms has not been well characterized.

PURPOSE

The Cryo-FIRST trial evaluated AAD treatment against pulmonary vein isolation (PVI) with a cryoballoon catheter (Arctic Front Advance; Medtronic, Inc.) as a first-line rhythm control therapy in patients with symptomatic paroxysmal AF. This current data analysis examines the QoL and symptoms endpoints.

METHODS

Patients with symptomatic PAF free of heart disease who had not been administered class I or III AAD therapy for >48 hours were enrolled at18 sites in 9 countries (Europe, Australia, and Latin America). Patients were randomized (1:1) to cryoballoon CA (Arctic Front Advance, Medtronic) or AAD therapy (Class IC or III). Subjects were followed at 1, 3, 6, 9, and 12 months. Palpitations were monitored by a patient diary. QoL was evaluated using the Atrial Fibrillation Effect on Quality of Life (AFEQT) and SF-36 v2 questionnaires. Health domains and component scores from the SF-36 were transformed to norm-based T scores. Mean adjusted differences between arms were compared at each follow-up.

RESULTS

Of the 218 patients randomized (age 52±13 years, 68% male) 86% completed the 12-month follow-up. Crossovers occurred in 9% of subjects (N=20), including: 1 subject in the cryoablation arm and 19 subjects in the AAD arm. At 12 months, 86.5% of the patients in the cryoablation arm and 70.4% of the patients in the AAD arm where without symptoms (EHRA score 1). The incidence rate of symptomatic palpitations was lower in the CA (7.61 days/year) compared to the AAD arm (18.96 days/year; IRR=0.40, 95% CI: 0.24-0.69; P<0.001). There were no group differences in baseline AFEQT or SF-36 scores. The mean AFEQT summary score was more favorable in the CA vs. AAD group at 3, 6, 9 and 12 months. At 12 months,the adjusted mean difference was 9.9 points (95%CI: 5.5-14.2; P < .0001, Figure). All AFEQT domain scores were also more favorable in the cryoballoon group at 12 months (Figure). A significant and meaningful adjusted mean difference favoring CA was observed for the SF-36 physical component score at month 9 (2.0 points, p=0.018). No other significant and meaningful differences were observed in the physical or mental component scores or health domain scores between groups.

CONCLUSIONS

Cryoballoon CA was superior to AAD therapy for improving AF-specific QoL and reducing symptoms in treatment naïve patients with symptomatic PAF.

Clin Res Cardiol (2021) DOI DOI https://doi.org/10.1007/s00392-021-01843-w
Quality of life and symptoms during initial rhythm control therapy for Atrial Fibrillation in the Cryo-FIRST study: A comparison between cryoballoon ablation versus antiarrhythmic drug therapy
M. Kuniss¹, V. Velagic², G.-B. Chierchia³, J. S. Hermida⁴, S. Healey⁵, G. Arena⁶, N. Badenco⁷, C. Meyer⁸, J. Chen⁹, S. Iacopino¹⁰, F. Anselme¹¹, N. Pavlovic¹², für die Studiengruppe: Cryo-FIRST
¹Abteilung für Kardiologie, Kerckhoff Klinik GmbH, Bad Nauheim; ²University Hospital Centre Zagreb, Zagreb, HR; ³Universitair Ziekenhuis Brussel, Brussel, BE; ⁴Centre Hospitalier Universitaire d'Amiens-Picardie, Amiens, FR; ⁵Monash Health, Clayton, AU; ⁶Ospedale Apuane, Massa Carrara, IT; ⁷AP-HP Sorbonne Université, ICAN Institute, Hopital Pitié-Salpétrière, Paris, FR; ⁸University Heart Center, Hamburg; ⁹Haukeland University Hospital, Bergen, NO; ¹⁰Maria Cecilia Hospital, Cotignola, IT; ¹¹CHU de Rouen, Rouen, FR; ¹²Sestre Milosrdnice University Clinical Hospital Centre, Zagreb, HR;
BACKGROUND Following clinical guidelines, catheter ablation is a recommended treatment for patients with symptomatic drug-refractory paroxysmal atrial fibrillation (AF), as patients try to alleviate AF symptoms that reduce Quality of Life (QoL). Ablation as a first-line rhythm control strategy is superior to antiarrhythmic drugs (AADs) for preventing atrial fibrillation (AF) recurrence; the impact of first-line ablation on quality of life (QoL) and symptoms has not been well characterized. PURPOSE The Cryo-FIRST trial evaluated AAD treatment against pulmonary vein isolation (PVI) with a cryoballoon catheter (Arctic Front Advance; Medtronic, Inc.) as a first-line rhythm control therapy in patients with symptomatic paroxysmal AF. This current data analysis examines the QoL and symptoms endpoints. METHODS Patients with symptomatic PAF free of heart disease who had not been administered class I or III AAD therapy for >48 hours were enrolled at18 sites in 9 countries (Europe, Australia, and Latin America). Patients were randomized (1:1) to cryoballoon CA (Arctic Front Advance, Medtronic) or AAD therapy (Class IC or III). Subjects were followed at 1, 3, 6, 9, and 12 months. Palpitations were monitored by a patient diary. QoL was evaluated using the Atrial Fibrillation Effect on Quality of Life (AFEQT) and SF-36 v2 questionnaires. Health domains and component scores from the SF-36 were transformed to norm-based T scores. Mean adjusted differences between arms were compared at each follow-up. RESULTS Of the 218 patients randomized (age 52±13 years, 68% male) 86% completed the 12-month follow-up. Crossovers occurred in 9% of subjects (N=20), including: 1 subject in the cryoablation arm and 19 subjects in the AAD arm. At 12 months, 86.5% of the patients in the cryoablation arm and 70.4% of the patients in the AAD arm where without symptoms (EHRA score 1). The incidence rate of symptomatic palpitations was lower in the CA (7.61 days/year) compared to the AAD arm (18.96 days/year; IRR=0.40, 95% CI: 0.24-0.69; P<0.001). There were no group differences in baseline AFEQT or SF-36 scores. The mean AFEQT summary score was more favorable in the CA vs. AAD group at 3, 6, 9 and 12 months. At 12 months,the adjusted mean difference was 9.9 points (95%CI: 5.5-14.2; P < .0001, Figure). All AFEQT domain scores were also more favorable in the cryoballoon group at 12 months (Figure). A significant and meaningful adjusted mean difference favoring CA was observed for the SF-36 physical component score at month 9 (2.0 points, p=0.018). No other significant and meaningful differences were observed in the physical or mental component scores or health domain scores between groups. CONCLUSIONS Cryoballoon CA was superior to AAD therapy for improving AF-specific QoL and reducing symptoms in treatment naïve patients with symptomatic PAF.
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