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Updated: Jun 14, 2025
Closure of a Patent Foramen Ovale PFO: An Intervention Sequence
Published on: December 23, 2022
Flecainide to Prevent Atrial Arrhythmia After Patent Foramen Ovale Closure: AFLOAT Study, A Randomized Clinical Trial
Marie Hauguel-Moreau1, Paul Guedeney2, Claire Dauphin3
1ACTION Study Group, CESP, INSERM U1018, Department of Cardiology, Ambroise Paré Hospital (AP-HP), Université de Versailles-Saint Quentin, Boulogne, France (M.H.-M.).
Insights
Flecainide did not prevent atrial arrhythmia (AA) after patent foramen ovale (PFO) closure in a recent trial. Atrial arrhythmia occurred in 28.5% of patients within six months post-procedure, primarily in the first month.
Area of Science:
- Cardiology
- Interventional Cardiology
- Electrophysiology
Background:
- The incidence of atrial arrhythmia (AA) following patent foramen ovale (PFO) closure is not well-established.
- Preventive strategies for post-PFO closure AA require further investigation.
Purpose of the Study:
- To assess the efficacy of flecainide in preventing AA within the first three months after PFO closure.
- To compare the effectiveness of three versus six months of flecainide treatment for AA prevention post-PFO closure.
Main Methods:
- A prospective, multicentre, randomized, open-label superiority trial (AFLOAT) with blinded endpoint evaluation.
- 186 patients were randomized to receive 3 months of flecainide, 6 months of flecainide, or standard of care post-PFO closure.
- The primary endpoint was the percentage of patients with AA (≥30 seconds) detected by an insertable cardiac monitor within 3 months.
Main Results:
- Atrial arrhythmia (≥30 seconds) occurred in 28.5% of patients within six months post-PFO closure, with 86.8% of events in the first month.
- Flecainide treatment (3 or 6 months) did not significantly reduce the incidence of AA compared to standard of care.
- No significant difference was observed between 3-month and 6-month flecainide treatment durations for AA prevention.
Conclusions:
- Atrial arrhythmia is a common complication after PFO closure, predominantly occurring within the first month.
- Flecainide, at the tested dosage and duration, is not effective in preventing atrial arrhythmia after PFO closure.
- Further research is needed to identify effective preventive strategies for AA post-PFO closure.
Background:
The real incidence of atrial arrhythmia (AA) after patent foramen ovale (PFO) closure and whether this complication can be prevented remain unknown. We assessed whether flecainide is effective to prevent AA during the first 3 months after PFO closure, and whether 6 months of treatment with flecainide is more effective than 3 months to prevent AA after PFO closure.
Methods:
AFLOAT (Assessment of Flecainide to Lower the Patent Foramen Ovale Closure Risk of Atrial Fibrillation or Tachycardia Trial) is a prospective, multicentre, randomized, open-label, superiority trial with a blind evaluation of all the end points (PROBE [Prospective Randomized Open, Blinded End Point] design). Patients were randomized in a 1:1:1 ratio after PFO closure to receive flecainide (150 mg once daily in a sustained-release dose) for 3 months, flecainide (150 mg once daily in a sustained-release dose) for 6 months, or no additional treatment (standard of care) for 6 months. The primary end point was the percentage of patients with at least 1 episode of AA (≥30 seconds) recorded within 3 months after PFO closure on long-term monitoring with an insertable cardiac monitor. The secondary end point was the percentage of patients with at least 1 episode of AA (≥30 seconds) recorded with insertable cardiac monitor during the 3- to 6-month period after PFO closure.
Results:
A total of 186 patients were included (mean age, 54 years; 68.8% men) and AA (≥30 seconds) occurred in 53 patients (28.5%) during the 6-month follow-up; 86.8% of these AA events occurred in the first month after PFO closure. The primary outcome occurred in 33 of 123 (26.8%) and 16 of 63 (25.4%) patients receiving flecainide for at least 3 months or standard of care, respectively (risk difference, 1.4% [95% CI, -12.9% to 13.8%]; NS). The secondary end point occurred in 3 of 60 (5.0%), 4 of 63 (6.3%), and 5 of 63 (7.9%) patients receiving flecainide for 6 months, for 3 months, or standard of care, respectively (risk difference, -2.9% [95% CI, -12.7% to 6.9%], and risk difference, -1.6% [95% CI, -11.8% to 8.6%], respectively).
Conclusions:
In the first 6 months after successful PFO closure, AA (≥30 seconds) occurred in 28.5% of cases, mostly in the first month after the procedure. Flecainide did not prevent AA after PFO closure.
Registration:
URL: https://www.clinicaltrials.gov; Unique identifier: NCT05213104.
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