PFO Closure in Older Patients with Embolic Stroke of Undetermined Source
Dania Mallick1, Ana Torres1, Mohammad Ahmed2, Alan T Davis2, Brandon Vieder3, Asad Ahrar2, Nadeem Khan4, Malgorzata Miller4, Nabil Wees2, Elizabeth Evans2, Muhib Khan5, Jiangyong Min6
1Neurology, Corewell Health, 2Corewell Health, 3MIND institute, 4Spectrum Health, 5mayo clinic, 6Spectrum Health Neuroscience
Objective:
We aim to investigate the benefit of patent foramen ovale (PFO) closure in older patients with embolic stroke of undetermined source (ESUS). Patients were carefully selected after an evaluation by a group of neurologists and cardiologists.
Background:

PFO closure is recommended for patients younger than 60 years with ESUS. However, the role of PFO closure in patients older than 60 years is unclear.

Design/Methods:
This single-center observational study recruited patients older than 60 years with ESUS, who had a PFO closure following presumed PFO-related ischemic stroke. The primary outcome was a composite of recurrent ischemic stroke, transient ischemic attack, or fatal stroke that occurred up to 5 years following PFO closure. The safety outcome was the occurrence of any complications after a PFO closure, including new-onset atrial fibrillation (AF).
Results:

A total of 64 patients were included (mean age 65.4±5.2), 39 of which were male (61.9%). Mean RoPE score was 4. Procedure-related complications, including new onset AF were low (1.6%). After a median follow-up of 2.4 years, patients older than 60 years demonstrated a high incidence of recurrent ischemic stroke (6.3%, 4/64), recurrent transient ischemic attack (3.1%, 2/64), but no recurrent fatal stroke (0%, 0/64) as their younger (age<60) counterparts (1.5% overall recurrent cerebrovascular events from 6 clinical trials). However, there was an overall 98.3% freedom from a recurrent stroke following PFO closure (95% CI: 88.4%, 99.8%) in this older population with ESUS.

Conclusions:

In patients with cryptogenic stroke who are older than 60 years, PFO closure demonstrated similar safety profiles but was associated with a relatively high risk of recurrent ischemic stroke compared to their younger counterparts reported in previous 6 trials (CLOSE, CLOSURE-I, DEFENCE-PFO, REDUCE, RESPECT and PC Trial). Randomized trials compared to same-age patients are warranted in this population.

10.1212/WNL.0000000000205181