Title : When should Physicians Consider Referring Older Patients with Suspected PFO-Related Stroke for Device Closure?
Abstract:
Background: Guidelines recommend patent foramen ovale (PFO) closure for secondary prevention after cryptogenic stroke in patients aged 18-65 years, but there is limited evidence to guide management of older adults. This research aims to assess the efficacy, safety and methodological quality of trials comparing secondary prevention PFO closure with medial therapy alone (MTA) in patients aged ≥60 years.
Methods: A PubMed search identified four studies comparing PFO closure with MTA in older patients – PFOSK (South Korea), PT (Taiwan), DEFENSE (South Korea) and PFOG (Germany). Primary analyses evaluated study quality – patient selection, allocation, crossover and adherence. Secondary analyses compared recurrent cerebral ischaemia, mortality, new-onset atrial fibrillation (AF) and disability.
Results: In 644 patients ≥60 years old, PFO closure was associated with a 45% (95% CI 0.35-0.86, p=0.0091) reduction in recurrent cerebral ischaemia and an 85% (95% CI 0.05-0.49, p=0.0016) reduction in mortality. Lower disability scores and increased incidence of new-onset AF (RR 2.15, 95% CI 1.07-4.32, p=0.0306) was observed in closure groups. Study quality was limited by heterogeneity in medical regimens and closure protocols, crossover between treatment arms and imbalances in baseline characteristics, with closure groups generally younger and possessing larger shunt sizes.
Conclusions: In patients aged ≥60 years, PFO closure appears to reduce the risk of recurrence ischaemic events and mortality, particularly in those with ‘high-risk’ PFO features. However, variability in study designs and low event rates limit certainty. Large, standardised trials are warranted to provide evidence for guideline recommendations in this population.
