New-onset atrial fibrillation is common after percutaneous PFO closure, occurring in 11.2% of patients over long-term follow-up, with early postprocedural clustering and independent associations with increasing age, larger occluder device size, and valvular regurgitation.
Key Findings
Results
New-onset atrial fibrillation occurred in 11.2% of patients following percutaneous PFO closure over long-term follow-up.
97 out of 867 patients developed new-onset AF during a median follow-up of 11.7 years (IQR 6.3–16.8 years)
The incidence rate was 1.0 per 100 patient-years
The study cohort had a median age of 51 years (IQR 42–58), with 47% female patients
PFO closure was performed for secondary stroke prevention in 86% of patients
Patients were retrospectively included from a single tertiary care centre between 1999 and 2021
Results
AF diagnoses clustered early after PFO closure, with more than a quarter occurring within the first 3 months.
26.8% of all new-onset AF cases occurred within the first 3 months after closure
Time-to-event analysis was performed using cumulative incidence functions
This early postprocedural clustering pattern was a key temporal finding of the study
Results
Higher age at the time of PFO closure was independently associated with new-onset AF.
Hazard ratio of 1.05 per year of age (95% CI 1.03 to 1.07) in multivariable Cox proportional hazards regression
This association was statistically significant and identified as an independent risk factor
Multivariable analysis adjusted for multiple clinical factors simultaneously
Results
Larger occluder device size was independently associated with new-onset AF after PFO closure.
Hazard ratio of 1.09 per mm of device size (95% CI 1.03 to 1.16) in multivariable analysis
This finding suggests a potential mechanical or procedural contribution to AF risk
Device size was analyzed as a continuous variable in millimeters
Results
Any moderate or severe valvular regurgitation was the strongest independent risk factor for new-onset AF after PFO closure.
Hazard ratio of 3.70 (95% CI 1.65 to 8.33) in multivariable analysis
This was the largest effect size among the three independently associated factors identified
The association was statistically significant and independent of age and device size
Methods
The study population was predominantly middle-aged adults undergoing PFO closure primarily for secondary stroke prevention.
867 patients were included, with a median age of 51 years (IQR 42–58)
47% of patients were female
86% of patients underwent PFO closure for secondary stroke prevention (cryptogenic stroke)
Patients aged ≥16 years were eligible for inclusion
New-onset AF was identified through systematic review of electronic health records
What This Means
This research suggests that a significant proportion of patients who undergo a minimally invasive procedure to close a patent foramen ovale (PFO) — a small hole between the upper chambers of the heart present from birth — will develop atrial fibrillation (AF), an irregular heart rhythm, over the long term. Studying 867 patients over nearly 12 years on average, researchers found that about 1 in 9 patients (11.2%) developed new-onset AF after the closure procedure. Importantly, more than one-quarter of these AF cases appeared within just the first three months after the procedure, suggesting the procedure itself may trigger some cases of AF in the short term.
The study also identified three factors that were independently linked to a higher risk of developing AF: being older at the time of the procedure, having a larger closure device implanted, and having moderate or severe leakiness in one or more heart valves (valvular regurgitation). The association with valvular regurgitation was particularly strong, with affected patients having more than 3.5 times the risk of developing AF compared to those without this condition. These findings held up even after accounting for other variables that could influence the results.
This research suggests that patients undergoing PFO closure — most of whom have had a stroke and are trying to prevent another — should be monitored closely for irregular heart rhythms, especially in the months immediately following the procedure. Clinicians may want to pay particular attention to older patients, those requiring larger devices, and those with pre-existing valve problems. Because AF itself can increase stroke risk, identifying and managing it after PFO closure is clinically important.
Rommens O, Blondeel M, Maes M, Goidts M, Garweg C, Troost E, et al.. (2026). Long-term incidence and risk factors of atrial fibrillation after percutaneous patent foramen ovale occlusion: a retrospective cohort study.. Open heart. https://doi.org/10.1136/openhrt-2026-004344