Long-term cerebrovascular outcomes of patients undergoing percutaneous patent foramen ovale closure in observational studies: a systematic review and meta-analysis.

OBJECTIVES

Patent foramen ovale (PFO) closure is recommended for patients who experience a cryptogenic stroke attributable to PFO. Although few randomized control trials (RCTs) have captured long-term effectiveness of PFO closure, observational data has been abundant. This is the first systematic review of observational studies determining incidence of long-term adverse outcomes in adults who underwent transcatheter PFO closure, with comparisons to findings from RCTs.

METHODS

Medline, Cochrane, and Embase databases were searched from inception to October 2023. Only observational studies with ≥4 years of mean or median follow-up were included. A meta-analysis was conducted to calculate the incidence of recurrent stroke after PFO closure.

RESULTS

After reviewing 2,432 records, 13 prospective and 12 retrospective cohort studies were included. Average follow-up lengths ranged from 4 to 12.3 years, and sample sizes from 75 to 1,533 participants. The average age ranged between 43.5-63.0, and 24.0-72.8% patients had an atrial septal aneurysm. The incidence of stroke was 0.34 per 100 person-years (I2 = 67%). This was similar to rates from four RCTs that were used for comparison (0.35 per 100 person-years, I2= 51%). There was a significant improvement in heterogeneity once the study with one of the largest follow-up was removed.

CONCLUSIONS

Real-world PFO closure studies with long-term follow-up report similar outcomes as RCTs which is important considering the exclusion of several important populations from trials. Future observational studies should include more rigorous reporting of follow-up strategies and explore different long-term adverse outcomes.