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

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

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

Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
NIkola Pavlovic ◽  
Malte Kuniss ◽  
Vedran Velagic ◽  
Jean-Sylvain Hermida ◽  
Stewart Healey ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Atrial Fibrillation ◽  
Catheter Ablation ◽  
Paroxysmal Atrial Fibrillation ◽  
First Line ◽  
Sf 36 ◽  
Treatment Naïve ◽  
Component Scores

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.

scholarly journals Impact of initial rhythm control with cryoballoon ablation versus drug therapy on atrial fibrillation recurrence and quality of life: results from the Cryo-FIRST study

EP Europace ◽  
2021 ◽  
Vol 23 (Supplement_3) ◽  
Author(s):  
N Pavlovic ◽  
M Kuniss ◽  
V Velagic ◽  
JS Hermida ◽  
S Healey ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Atrial Fibrillation ◽  
Summary Score ◽  
Group Differences ◽  
Cryoballoon Ablation ◽  
First Line ◽  
Significant Group ◽  
Sf 36 ◽  
Af Recurrence

Abstract Funding Acknowledgements Type of funding sources: Private company. Main funding source(s): Medtronic OnBehalf The Cryo-FIRST Investigators Background Cryoballoon ablation (CBA) as a first-line rhythm control strategy is superior to antiarrhythmic drugs (AADs) for preventing atrial arrhythmia recurrence; however, the impact of first-line CBA specifically on atrial fibrillation (AF) recurrence and quality of life (QoL) has not been well characterized. Purpose To compare AF recurrence and QoL following first-line CBA vs. AAD therapy in patients with paroxysmal AF within the CryoFIRST trial (NCT01803438). Methods Patients with recurrent symptomatic paroxysmal AF who had not been administered class I or III AAD therapy for &gt;48 hours were enrolled at 18 sites in 9 countries. Patients were randomized (1:1) to CBA or AAD treatment (Class I or III). Subjects were followed by 7-day Holter at 1, 3, 6, 9, and 12 months. Time-to-first AF recurrence outside of a 90-day blanking period was estimated by Kaplan-Meier analysis.  QoL was evaluated using the Atrial Fibrillation Effect on Quality of Life (AFEQT) and 36-Item Short Form Health Survey (SF-36) v2 questionnaires. Results Of the 218 randomized subjects, 187 (86%) completed the 12-month follow-up. By intention-to-treat (ITT) analysis, freedom from AF after blanking was achieved in 86.6% in the CBA and 74.5% in the AAD group (p = 0.023).  There was no difference in the time-to-first serious adverse event between groups. In total, 84.3% of patients in the CBA vs. 75.0% of patients in the AAD arm had a clinically important improvement (≥5 points) in the AFEQT summary score.  The adjusted mean difference in the AFEQT summary score at 12 months was 9.9 points higher in the CBA group (95% CI: 5.5-14.2; P &lt; 0.001).  All AFEQT subscale scores were more favorable in the CBA vs. AAD group at 12 months.  There were no significant group differences in any of the SF-36 health domain scores at 12 months in the ITT analysis.  In the per-protocol analysis, clinically important and significant group differences in favor of CBA were observed at 12 months for 3 of 8 SF-36 health domain scores (physical functioning, general health and social functioning). Conclusion CBA is superior to AAD for preventing AF recurrence and improving AF-specific QoL in patients with paroxysmal AF. AFEQT Scores at Baseline and 12 MonthsAFEQT Score, Mean ± Standard DeviationCBAAADAdjusted Mean Difference at 12 Months (CBA vs. AAD)p-valueBaseline12 MonthsBaseline12 MonthsDaily Activities65.3 ± 25.887.8 ± 17.161.0 ± 27.976.6 ± 25.48.9 (3.2-14.6)0.002Symptoms59.9 ± 24.888.8 ± 15.658.4 ± 25.280.9 ± 22.27.1 (1.5-12.7)0.014Treatment Concern59.9 ± 23.189.8 ± 14.060.4 ± 24.577.7 ± 22.212.7 (7.9-17.5)&lt;0.001AFEQT, Atrial Fibrillation Effect on Quality of Life questionnaire. CBA, cryoballoon ablation. AAD antiarrhythmic drug.Abstract Figure. Freedom From Atrial Fibrillation

Five year follow-up of symptoms and health-related quality of life in patients with atrial fibrillation treated with catheter ablation

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
U Walfridsson ◽  
A Hassel Jonsson ◽  
L.O Karlsson ◽  
H Almroth ◽  
I Liuba ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Atrial Fibrillation ◽  
Catheter Ablation ◽  
Funding Source ◽  
Health Related Quality ◽  
Female Sex ◽  
Related Quality ◽  
Health Related

Abstract Background In accordance with current guidelines the primary indication for catheter ablation (CA) of atrial fibrillation (AF) is to reduce symptoms and thereby improve health-related quality of life (HRQoL). Even though, there are data showing patients' symptom situation before treatment, long-term follow up data are sparse. Purpose To assess symptoms and HRQoL five years after CA with the validated arrhythmia-specific questionnaire ASTA, in a large cohort of patients treated with catheter ablation due to AF. Methods 1323 consecutive patients who underwent CA of AF at one university hospital in Sweden filled out the ASTA questionnaire before the procedure, mostly electronically, and 418 patients at five years follow-up. If not responded within 1 month the patient got a reminder. Results Five years after CA and after 1.6 procedures/patient, half of the patients (50%) reported freedom of symptoms, 18% had a major reduction of symptoms (&gt;50% symptom reduction compared to baseline assessments) and 14% had a minor reduction of symptoms (between 10% – 50% reduction) while only 9% of the patients reported no effect on symptoms after the CA and 9% experienced a worsening of their symptoms after the treatment. Factors predicting presence of symptoms at the five-year follow-up were female sex (HR: 1.8; 1.2–2.8), Body Mass Index &gt;35 (HR: 3.9; 1.6–9.8) and having ischemic heart disease (IHD) (HR: 2.6; 1.2–5.9). At the five years follow-up the symptoms breathlessness during activity, weakness/fatigue and tiredness were still the most commonly reported as well as regarding HRQoL it was impaired physical ability and deteriorated life situation. Conclusions Catheter ablation has a long-lasting effect and change the natural course of AF, as more than 50% of patients did not experience any symptoms and 32% were improved, while 18% had no treatment effect or worsening of symptoms. Factors predicting remaining symptoms five years after CA were female sex, presence of IHD and obesity, a reminder to encourage life style managements. ASTA symptom scale Funding Acknowledgement Type of funding source: Foundation. Main funding source(s): The Carldavid Jönsson Research Foundation and the County Council of Östergötland (FORSS).

scholarly journals Ablation Versus Drug Therapy for Atrial Fibrillation in Heart Failure: Results from the CABANA Trial

Circulation ◽  
2021 ◽  
Author(s):  
Douglas L. Packer ◽  
Jonathan P Piccini ◽  
Kristi H Monahan ◽  
Hussein R Al-Khalidi ◽  
Adam P Silverstein ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Heart Failure ◽  
Atrial Fibrillation ◽  
Drug Therapy ◽  
Catheter Ablation ◽  
Left Ventricular ◽  
Relative Reduction ◽  
Af Recurrence

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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