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 in | Circulation (New York, N.Y.) Vol. 142; no. Suppl_3 Suppl 3; p. A13916 |
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Main Authors | , , , , , , , , , , , |
Format | Journal Article |
Language | English |
Published |
by the American College of Cardiology Foundation and the American Heart Association, Inc
17.11.2020
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Online Access | Get full text |
ISSN | 0009-7322 1524-4539 |
DOI | 10.1161/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. |
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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 |
AuthorAffiliation_xml | – name: 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 |
Author_xml | – sequence: 1 givenname: NIkola surname: Pavlovic fullname: Pavlovic, NIkola organization: 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 – sequence: 2 givenname: Malte surname: Kuniss fullname: Kuniss, Malte – sequence: 3 givenname: Vedran surname: Velagic fullname: Velagic, Vedran – sequence: 4 givenname: Jean-Sylvain surname: Hermida fullname: Hermida, Jean-Sylvain – sequence: 5 givenname: Stewart surname: Healey fullname: Healey, Stewart – sequence: 6 givenname: Giuseppe surname: Arena fullname: Arena, Giuseppe – sequence: 7 givenname: Nicolas surname: Badenco fullname: Badenco, Nicolas – sequence: 8 givenname: Christian surname: Meyer fullname: Meyer, Christian – sequence: 9 givenname: Jian surname: Chen fullname: Chen, Jian – sequence: 10 givenname: Saverio surname: Iacopino fullname: Iacopino, Saverio – sequence: 11 givenname: Frederic surname: Anselme fullname: Anselme, Frederic – sequence: 12 givenname: Gian-Battista surname: Chierchia fullname: Chierchia, Gian-Battista |
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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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