A new meta-analysis of patients undergoing percutaneous closure of patent foramen ovale (PFO) after cryptogenic shock supports previous studies that indicate PFO closure is associated with an increased risk of atrial fibrillation. However, it also shows that device-related atrial fibrillation occurs early, is transient, and that only 0.1% of patients with new-onset atrial fibrillation will have a stroke related to the atrial fibrillation.
Akram Y Elgendy (Division of Cardiovascular Medicine, Department of Medicine, University of Florida, Gainesville, USA) and others write in EuroIntervention that prior studies show percutaneous PFO closure “increased the risk of atrial fibrillation and atrial flutter”. They add: “Thus, we sought to systematically evaluate the incidence of new-onset atrial fibrillation post procedure PFO closure and to determine the risk of stroke associated with new-onset atrial fibrillation.”
Reviewing data from eight trials, Elgendy et al identified 3,924 patients who had been enrolled in a trial comparing PFO closure with standard therapy (control group). At a mean follow-up of 2.8±1.7 years, the weighted mean incidence of atrial fibrillation in the PFO group was 3.2% vs. 0.47% for the control group (p<0.01). Additionally, the incidence of atrial fibrillation was still higher among patients who underwent PFO closure even after patients who received the STARFlex device were excluded from the analysis—a prior network analysis, the authors note, found that the incidence of new-onset atrial fibrillation was more pronounced with this device vs. Amplatzer PFO Occluder (Abbott) or the HELEX device (Gore). However, they report that the risk of atrial fibrillation was not increased when “limited to trials using the Amplatzer PFO Occluder”.
However, PFO closure was associated with a higher incidence of early-onset atrial fibrillation vs. late-onset atrial fibrillation (2.9% vs. 0.52%; p=0.0001). “Over three-fourths of device-associated atrial fibrillation resolved (spontaneously or with cardioversion) without recurrence. The pooled incidence of stroke presumably caused by device-associated with atrial fibrillation in the PFO closure group was 0.1%,” Elgendy et al write.
They conclude: “PFO closure is associated with an increased risk of new-onset atrial fibrillation. The majority of device-associated atrial fibrillation incidences occurred early, were transient with no documented recurrence (76%) and only 0.1% of patients randomised to a device had stroke presumably caused by device-associated atrial fibrillation.”
Elgendy told Cardiovascular News that the study raises the question of whether or not the risk of new-onset atrial fibrillation is a barrier to using PFO closure.