Assessment of Flecainide to Lower the patent foramen Ovale closure risk of Atrial fibrillation or Tachycardia - AFLOAT

Nov 11, 2024
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Author/Summarized by Author:
Dharam J. Kumbhani, MD, SM, FACC
Summary Reviewer:
Kim A. Eagle, MD, MACC
Trial Sponsor:
ACTION Group Foundation
Date Published:
09/02/2024
Original Posted Date:
11/11/2024
References

Contribution To Literature:

The AFLOAT trial showed that atrial arrhythmias were commonly noted post-PFO closure on systematic intracardiac monitoring, but flecainide did not reduce the incidence of these atrial arrhythmias.

Description:

The goal of the trial was to compare the efficacy of flecainide compared with standard of care in preventing atrial fibrillation (AF) post-patent foramen ovale (PFO) closure.

Study Design

All patients underwent successful PFO closure and then received an insertable cardiac monitor (ICM). After successful implantation of both devices, patients were randomized in a 1:1:1 ratio to flecainide (150 mg per day in a single sustained-release [SR] dose) for 6 months (n = 60), flecainide (150 mg per day in a single SR dose) for 3 months (n = 63), or no additional treatment (standard of care) for 6 months (n = 63).

  • Total number of enrollees: 186
  • Duration of follow-up: 6 months
  • Mean patient age: 54 years
  • Percentage female: 31%

Inclusion criteria:

  • ≥18 years of age
  • Candidates for a procedure of PFO closure (secondary prevention of stroke, platypnea, decompression illness); the indication must have been confirmed by a multidisciplinary team

Exclusion criteria:

  • History of atrial arrhythmia (paroxysmal, persistent, or permanent)
  • Electrocardiography of ventricular pre-excitation or bundle-branch block (QRS >120 ms)
  • Ischemic heart disease
  • Dilated or hypertrophic cardiomyopathy
  • History of heart failure, severe valvular heart disease, left ventricular dysfunction (ejection fraction <50%)
  • Long QT interval or Brugada syndrome
  • The bradycardia-tachycardia syndrome (resting heart rate, ≤50 bpm, or repetitive sinoatrial blocks during waking hours)
  • Documentation of previous episodes of second- or third-degree atrioventricular block
  • High heart rate at baseline >100 bpm
  • Renal insufficiency (glomerular filtration rate estimated by the Cockroft and Gault formula <30 mL/min/m2)
  • Previous hypokalemia (potassium level <3 mmol/L)

Other salient features/characteristics:

  • Body mass index: 25.9 kg/m2
  • Migraine history: 16.1%
  • Indication for PFO closure for ischemic stroke/transient ischemic attack (TIA): 94.6%
  • RoPE score 6, PASCAL unlikely: 23.8%
  • Medications at discharge: aspirin and clopidogrel, 87.1%; oral anticoagulant, 8%
  • Devices used: Abbott Amplatzer, 55%; Gore Cardioform, 5%; Occlutech Figulla Flex II, 40%

Principal Findings:

The primary endpoint (proportion of patients with ≥1 episode of symptomatic or asymptomatic atrial arrhythmia ≥30 seconds recorded on long-term monitoring with ICM during the 3-month period following PFO closure) for flecainide vs. standard of care, was: 26.8% vs. 25.4% (p = 0.83).

Secondary outcomes:

  • Proportion of patients with ≥1episode of symptomatic or asymptomatic atrial arrhythmia (≥30 seconds) recorded on long-term monitoring with ICM between 3 and 6 months post-PFO closure for flecainide 150 mg for 3 months vs. 6 months vs. standard of care: 6.3% vs. 5.0% vs. 7.9% (p = 1.0)
  • Percentage of patients with symptomatic or asymptomatic AA episode (≥6 minutes) during the 3-month period after PFO closure for flecainide vs. standard of care: 22.0% vs. 17.5% (p > 0.05)
  • Recurrent stroke/TIA/death = 0

Interpretation:

The results of this trial indicate that atrial arrhythmias were noted in nearly one out of every four patients undergoing PFO closure on systematic intracardiac monitoring. The majority occurred within the first month and >75% lasted ≥6 minutes. Flecainide 150 mg did not reduce the incidence of these atrial arrhythmias. No differences in clinical outcomes were noted.

This is an interesting trial with a few caveats. Symptomatic atrial arrhythmias have been typically reported in 3-5% of patients undergoing PFO closure. The incidence rate noted in this trial is significantly higher and is likely related to systematic intracardiac monitoring in all patients. Physicians were unblinded to these findings and could change from antiplatelet therapy to anticoagulation if needed. Also, although the majority of PFO closures were performed for stroke/TIA indication, routine intracardiac monitoring was not utilized prior to PFO closure. It is possible that some of these patients may have had pre-existing atrial arrhythmias given that the mean age was 54 years. From an arrhythmia management standpoint, flecainide did not appear to be beneficial. It is unclear if other antiarrhythmics would be helpful for this indication.

References:

Hauguel-Moreau M, Guedeney P, Dauphin C, et al., for the ACTION Study Group. Flecainide to Prevent Atrial Arrhythmia After Patent Foramen Ovale Closure, the AFLOAT Study: A Randomized Clinical Trial. Circulation 2024;Sep 2:[Epub ahead of print].

Clinical Topics: Arrhythmias and Clinical EP, Congenital Heart Disease and Pediatric Cardiology, Atrial Fibrillation/Supraventricular Arrhythmias, Congenital Heart Disease, CHD and Pediatrics and Arrhythmias

Keywords: Atrial Fibrillation, Flecainide, Foramen Ovale, Patent, Heart Defects, Congenital


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