Catheter ablation improved quality of life more than drug therapy at 1 y in symptomatic atrial fibrillation

Background: In patients with heart failure (HF) and atrial fibrillation (AF), several clinical trials have reported improved outcomes, including freedom from AF recurrence, quality of life (QOL), and survival, with catheter ablation. This report describes the treatment-related outcomes of the AF patients with HF enrolled in the Catheter Ablation vs Antiarrhythmic Drug Therapy for Atrial Fibrillation (CABANA) trial. Methods: CABANA randomized 2204 patients with AF who were ≥65 years old or <65 with ≥1 risk factor for stroke at 126 sites to ablation with pulmonary vein isolation or drug therapy including rate/rhythm control drugs. Of these, 778 (35%) had NYHA class ≥ II at baseline and form the subject of this report. The CABANA primary endpoint was a composite of death, disabling stroke, serious bleeding, or cardiac arrest. Results: Of the 778 HF patients enrolled in CABANA, 378 were assigned to ablation and 400 to drug therapy. Ejection fraction (EF) at baseline was available for 571 patients (73%) and 9.3% of these had an EF <40%, while 11.7% had EFs between 40-50%. In the intention-to-treat analysis, the ablation arm had a 36% relative reduction in the primary composite endpoint (hazard ratio [HR] 0.64; 95% confidence interval [CI], 0.41 to 0.99) and a 43% relative reduction in all-cause mortality (HR 0.57; 95% CI, 0.33 to 0.96) compared to drug therapy alone over a median follow-up of 48.5 months. AF recurrence was decreased with ablation (HR 0.56; 95% CI, 0.42 to 0.74). The adjusted mean difference for the AF Effect on QOL (AFEQT) summary score averaged over the entire 60-month follow-up was 5.0 points favoring the ablation arm (95% CI, 2.5 to 7.4 points), and the Mayo AF-specific Symptom Inventory (MAFSI) frequency score difference was -2.0 points favoring ablation (95% CI, -2.9 to -1.2). Conclusions: In patients with atrial fibrillation enrolled in CABANA who had clinically diagnosed stable heart failure at trial entry, catheter ablation produced clinically important improvements in survival, freedom from AF recurrence, and quality of life relative to drug therapy. These results, obtained in a cohort most of whom had preserved left ventricular function, require independent trial verification. Clinical Trial Registration: URL: https://www.clinicaltrials.gov Unique Identifier: NCT00911508

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Quality of life measured in first-line therapy during the Cryo-FIRST study: a comparison between cryoballoon catheter ablation versus antiarrhythmic drug therapy

European Heart Journal ◽

10.1093/ehjci/ehaa946.0436 ◽

2020 ◽

Vol 41 (Supplement_2) ◽

Author(s):

G.B Chierchia ◽

N Pavlovic ◽

V Velagic ◽

J.S Hermida ◽

S Healy ◽

...

Keyword(s):

Quality Of Life ◽

Atrial Fibrillation ◽

Drug Therapy ◽

Catheter Ablation ◽

Funding Source ◽

Cryoballoon Ablation ◽

First Line ◽

Consensus Statements ◽

Treatment Naïve

Abstract Background By consensus statements, catheter ablation is a recommended treatment for patients with symptomatic drug-refractory paroxysmal atrial fibrillation (AF), as patients try to alleviate the burdensome AF symptoms that reduce the Quality of Life (QoL). Yet, first-line treatment of symptomatic patients via catheter ablation prior to initiation of antiarrhythmic drugs (AADs) is only a reasonable alternative (Class IIa). Clearly, more clinical data is necessary that compares catheter ablation to AAD therapy in treatment naïve patients. Purpose The Cryo-FIRST trial was designed to compare AAD treatment against pulmonary vein isolation (PVI) while using a cryoballoon catheter (Arctic Front Advance; Medtronic, Inc.). This current data analysis examines the QoL endpoints when comparing AADs to cryoballoon ablation in patients with symptomatic treatment naïve paroxysmal AF. Methods This randomized multicenter trial enrolled 220 patients from 18 sites in 9 countries (Europe, Australia, and Latin America) in a prospective open-blinded endpoint study design. Patients had not been administered a class I or III AAD for longer than 48 hours for inclusion into the study. Subjects were randomized (1:1) into a cohort that was administered AAD therapy or a cohort that received PVI via cryoablation. The prespecified QoL endpoint at 12 months was measured using the Atrial Fibrillation Effect on Quality of Life (AFEQT) scores, and QoL recordings were taken at baseline, 1, 3, 6, 9, and 12 months following the index treatment. 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 mean AFEQT summary score was more favorable in the catheter ablation group compared to the drug therapy 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<0.0001). Conclusions Cryoballoon ablation resulted in a significant improvement in QoL at 12 months compared to AAD therapy in treatment naïve patients with first-line symptomatic paroxysmal AF. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Medtronic International Trading Sàrl

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