When Should Physicians Consider Referring Elderly Patients with Suspected PFO-Related Stroke for Device Closure?

Area of Science:

• Cardiology
• Neurology
• Clinical Trials

Background:

• Current guidelines recommend PFO closure for secondary stroke prevention in younger adults (18-65).
• Evidence for PFO closure in elderly patients (≥ 60 years) remains limited.
• This study evaluates PFO closure versus medical therapy alone in older adults post-cryptogenic stroke.

Purpose of the Study:

• To assess the efficacy and safety of PFO closure compared to medical therapy alone in elderly patients (≥ 60 years) after cryptogenic stroke.
• To evaluate the methodological quality of existing trials in this population.
• To inform potential guideline recommendations for PFO closure in older adults.

Main Methods:

• A systematic literature search identified four relevant studies (PFOSK, PT, DEFENSE, PFOG).
• Primary analysis focused on study quality: patient selection, allocation, crossover, and adherence.
• Secondary analyses compared outcomes including recurrent ischemic events, mortality, new-onset atrial fibrillation (AF), and disability.

Main Results:

• In 644 elderly patients, PFO closure significantly reduced recurrent cerebral ischemia (45% reduction) and mortality (85% reduction).
• Closure groups showed lower disability scores but a higher incidence of new-onset AF (RR 2.15).
• Study quality was limited by heterogeneity in treatments, crossover, and baseline imbalances (age, shunt size).

Conclusions:

• PFO closure appears to reduce ischemic event recurrence and mortality in patients aged ≥ 60 years, especially those with high-risk PFO features.
• Variability in study designs and low event rates limit the certainty of these findings.
• Large, standardized trials are necessary to establish definitive evidence for guideline recommendations in this demographic.