PFO closure after thromboembolism linked to strong 20-year outcomes

Michael Walter | February 25, 2026 | Cardiovascular Business | Structural Heart Disease

A majority of medical devices involved in Class I recalls were never required by the U.S. Food and Drug Administration (FDA) to undergo premarket or postmarket clinical testing, according to new research published in Annals of Internal Medicine.[1]

Transcatheter patent foramen ovale (PFO) closure in patients who have experienced a PFO-associated embolism is associated with long-term safety and effectiveness, according to new 20-year data published in JAMA Cardiology.[1]

Researchers tracked data from 130 patients who underwent PFO closure at a single facility from 2001 to 2006 due to a PFO-associated stroke, transient ischemic attack (TIA) or peripheral embolism. Long-term follow-up data was gathered using medical records, phone calls and interviews with primary care physicians or cardiologists when necessary. While the mean age at the time of treatment was 46 years old, 51.5% of patients were women. The indication for PFO closure was stroke for 91 patients, a TIA for 45 patients and peripheral embolism for one patient. The mean Risk of Paradoxical Embolism score was 7.

A majority of patients were treated with the Amplatzer PFO occluder from Abbott. Abbott’s Amplatzer ASD closure device and St. Jude Medical’s Premere PFO closure device were used for the remaining cases.

Overall, after a median of 19.4 years, recurrent strokes and TIAs were infrequent. The recurrent stroke rate was 0.04 per 100 patients per year and the recurrent TIA rate was 0.25 per 100 patients per year. The single stroke occurred three years after treatment and was related to a vertebral artery dissection. That same patient also experienced two TIAs.

The authors did note that 13% of patients experienced a bleeding event after treatment, good for a rate of 0.7 per 100 patients per year. They all occurred in patients on antithrombotic therapy, and they were significantly more common among women than men.

“Most bleeding events occurred in women, aligning with prior evidence,” wrote first author Pablo Vidal-Calés, MD, a cardiologist with the Quebec Heart and Lung Institute, and colleagues. “These results highlight the importance of tailoring antithrombotic therapy duration to individual factors, such as age, sex and cardiovascular risk profile, balancing ischemic protection against bleeding risk.”

The group also noted that their research had certain limitations. It was a single-center study, for example, and the patients were relatively young. Even with those things in mind, however, they emphasized the importance of this analysis.

“This study provides, to our knowledge, the longest follow-up to date in patients undergoing transcatheter PFO closure after PFO-associated embolism, confirming its long-term safety and efficacy in reducing recurrent ischemic events,” they wrote.

Click here for the full study.