A single-center study with more than a decade of follow-up supports the long-term efficacy of patent foramen ovale (PFO) closure for the prevention of recurrent ischemic events, showing only 1 percent of patients had an ischemic stroke and 2.9 percent experienced a transient ischemic attack (TIA).
The study enrolled 201 patients who underwent PFO closure at an institution in Quebec City, Canada, following a cryptogenic embolism. Cryptogenic stroke (76 percent) was the most common reason for PFO closure, followed by TIA (32 percent) and systemic embolism (2 percent). Patients were 47 years old on average when they underwent the procedure and 51 percent of participants were women.
Lead author Jérôme Wintzer-Wehekind, MD, with Quebec Heart and Lung Institute, and colleagues noted most randomized studies of PFO closure had average follow-up periods between two and six years.
“Considering the (young) age of the patients undergoing PFO closure nowadays (mean age <50 years in all studies), we may anticipate a long life expectancy following PFO closure in this population,” they wrote in the Journal of the American College of Cardiology. “Limited data exist on long-term outcomes following PFO closure; it would therefore be important to obtain much longer-term follow-up data among PFO closure recipients to determine recurrent ischemic events as well as the occurrence of concomitant events such as atrial fibrillation or venous thrombosis at long-term follow-up.”
There were 13 deaths during the median 12 years of follow-up but all stemmed from noncardiovascular causes. Two patients experienced nondisabling strokes and six more had TIA.
Notably, the rate of major bleeding (2 percent) was higher than the ischemic stroke rate (1 percent), and each of those bleeding events occurred in patients taking antiplatelets in the form of aspirin or clopidogrel plus aspirin. About 20 percent of patients stopped antithrombotic therapy during the follow-up period—usually within the first year—and there was no evidence that this put them at greater risk for ischemic events.
The rate of major bleeding was calculated at 0.2 events per 100 patient years, well below the expected rate of 1.1 events based on the HAS-BLED score. Finding the right time to terminate antithrombotic therapy in these patients is particularly important, Wintzer-Wehekind et al. wrote, because given their relatively young age they could be exposed to higher bleeding risks for a longer duration if they remain on the medications.
The researchers acknowledged their study wasn’t powered to evaluate short- versus long-term antiplatelet therapy following PFO closure, and added that those who stopped treatment earlier tended to be younger and healthier.
“However, these results point out, for the first time, the importance of the bleeding burden among these patients, and suggest that stopping antiplatelet therapy several months after PFO closure (similar to what is usually done following atrial septal defect closure) may be a safe alternative,” they wrote. “Future randomized trials should determine the optimal duration of antiplatelet treatment post-PFO closure.”
Overall, Wintzer-Wehekind and co-authors concluded the short-term benefits observed with PFO closure extend beyond a decade of follow-up, with no late device-related events detected in their patients.
“Guidelines need to be amended, and PFO closure must be put first in the selection of preventive treatment after ischemic events in otherwise healthy people,” Swiss cardiologists Bernhard Meier, MD, and Fabian Nietlispach, MD, PhD, wrote in a related editorial. “PFO closure is the easiest, most effective, and probably most cost-efficient way of stroke prevention. And PFO closure for prevention of stroke recurrence is just the tip of the iceberg.”
The editorialists said PFO occlusion could also be used for primary stroke prevention, to improve migraine symptoms and for patients with hypercoagulability or planned major surgeries. They also agreed it may be time to “rethink” the strategy of permanent antiplatelets following PFO closure.
“For the first time, we learn that continuing even only acetylsalicylic acid confers a bothersome risk for bleeds without protecting against anything, once the prime culprit, the PFO, has been taken care of,” Meier and Nietlispach wrote.