Abstract 13916: Quality of Life Measured in First-line Therapy for Paroxysmal Atrial Fibrillation: A Comparison Between Cryoballoon Catheter Ablation versus Antiarrhythmic Drug Therapy

IntroductionThe Cryo-FIRST study (NCT01803438) demonstrated that pulmonary vein isolation (PVI) with cryoballoon catheter ablation (CA) is superior to antiarrhythmic drug (AAD) therapy as a first line treatment for the prevention of atrial arrhythmia recurrence in patients with paroxysmal atrial fib...

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Published inCirculation (New York, N.Y.) Vol. 142; no. Suppl_3 Suppl 3; p. A13916
Main Authors Pavlovic, NIkola, Kuniss, Malte, Velagic, Vedran, Hermida, Jean-Sylvain, Healey, Stewart, Arena, Giuseppe, Badenco, Nicolas, Meyer, Christian, Chen, Jian, Iacopino, Saverio, Anselme, Frederic, Chierchia, Gian-Battista
Format Journal Article
LanguageEnglish
Published by the American College of Cardiology Foundation and the American Heart Association, Inc 17.11.2020
Online AccessGet full text
ISSN0009-7322
1524-4539
DOI10.1161/circ.142.suppl_3.13916

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Abstract IntroductionThe Cryo-FIRST study (NCT01803438) demonstrated that pulmonary vein isolation (PVI) with cryoballoon catheter ablation (CA) is superior to antiarrhythmic drug (AAD) therapy as a first line treatment for the prevention of atrial arrhythmia recurrence in patients with paroxysmal atrial fibrillation (PAF). Earlier CA may also be beneficial for improving quality of life (QoL). HypothesisWe hypothesized that PVI with cyroballoon CA is superior to AAD therapy for improving QoL in treatment naïve patients with PAF. MethodsPatients with symptomatic PAF free of heart disease who had not been administered AAD therapy for >48 hours were enrolled at 18 sites in 9 countries. 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. 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. ResultsOf 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, CA-to-AADN=1, AAD-to-CAN=19). 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 12 months (88.9 vs. 78.1 points, respectively). The adjusted difference was 9.9 points (95%CI5.5-14.2; P < .0001, Figure). A significant adjusted mean difference favoring CA was observed for the SF-36 physical component score at months 3 (1.8 points, p=0.031) and 9 (2.0 points, p=0.018). No other differences were observed in the physical or mental component scores between groups. ConclusionsCryoballoon CA was superior to AAD therapy for improving AF-specific QoL in treatment naïve patients with symptomatic PAF.
AbstractList IntroductionThe Cryo-FIRST study (NCT01803438) demonstrated that pulmonary vein isolation (PVI) with cryoballoon catheter ablation (CA) is superior to antiarrhythmic drug (AAD) therapy as a first line treatment for the prevention of atrial arrhythmia recurrence in patients with paroxysmal atrial fibrillation (PAF). Earlier CA may also be beneficial for improving quality of life (QoL). HypothesisWe hypothesized that PVI with cyroballoon CA is superior to AAD therapy for improving QoL in treatment naïve patients with PAF. MethodsPatients with symptomatic PAF free of heart disease who had not been administered AAD therapy for >48 hours were enrolled at 18 sites in 9 countries. 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. 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. ResultsOf 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, CA-to-AADN=1, AAD-to-CAN=19). 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 12 months (88.9 vs. 78.1 points, respectively). The adjusted difference was 9.9 points (95%CI5.5-14.2; P < .0001, Figure). A significant adjusted mean difference favoring CA was observed for the SF-36 physical component score at months 3 (1.8 points, p=0.031) and 9 (2.0 points, p=0.018). No other differences were observed in the physical or mental component scores between groups. ConclusionsCryoballoon CA was superior to AAD therapy for improving AF-specific QoL in treatment naïve patients with symptomatic PAF.
Abstract only Introduction: The Cryo-FIRST study (NCT01803438) demonstrated that pulmonary vein isolation (PVI) with cryoballoon catheter ablation (CA) is superior to antiarrhythmic drug (AAD) therapy as a first line treatment for the prevention of atrial arrhythmia recurrence in patients with paroxysmal atrial fibrillation (PAF). Earlier CA may also be beneficial for improving quality of life (QoL). Hypothesis: We hypothesized that PVI with cyroballoon CA is superior to AAD therapy for improving QoL in treatment naïve patients with PAF. Methods: Patients with symptomatic PAF free of heart disease who had not been administered AAD therapy for >48 hours were enrolled at 18 sites in 9 countries. 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. 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, CA-to-AAD: N=1, AAD-to-CA: N=19). 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 12 months (88.9 vs. 78.1 points, respectively). The adjusted difference was 9.9 points (95%CI: 5.5-14.2; P < .0001, Figure). A significant adjusted mean difference favoring CA was observed for the SF-36 physical component score at months 3 (1.8 points, p=0.031) and 9 (2.0 points, p=0.018). No other differences were observed in the physical or mental component scores between groups. Conclusions: Cryoballoon CA was superior to AAD therapy for improving AF-specific QoL in treatment naïve patients with symptomatic PAF.
Author Hermida, Jean-Sylvain
Iacopino, Saverio
Kuniss, Malte
Healey, Stewart
Meyer, Christian
Arena, Giuseppe
Velagic, Vedran
Badenco, Nicolas
Chen, Jian
Pavlovic, NIkola
Chierchia, Gian-Battista
Anselme, Frederic
AuthorAffiliation Sestre Milosrdnice Univ Hosp Cntr, Zagreb, Croatia Kerckhoff Heart Cntr, Bad Nauheim Univ Hosp Cntr Zagreb, Zagreb, Croatia Cntr Hosp Univ d'Amiens-Picardie, Amiens, France Monash Health, Clayton, Australia Ospedale Apuane, Massa Carrara, Italy AP-HP Sorbonne Université, ICAN Institute, Hopital Pitié-Salpétrière, Paris, France Univ Heart Cntr, Hamburg, Germany Haukeland Univ Hosp, Bergen, Norway Maria Cecilia Hosp, Cotignola, Italy CHU de Rouen, Rouen, Rouen, France Heart Rhythm Management Cntr, Univ Ziekenhuis Brussel, Jette, Belgium
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Title Abstract 13916: Quality of Life Measured in First-line Therapy for Paroxysmal Atrial Fibrillation: A Comparison Between Cryoballoon Catheter Ablation versus Antiarrhythmic Drug Therapy
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