Patent Foramen Ovale Closure for Secondary Stroke Prevention in Patients Aged 60 or Older Is Safe
Brandon May1, Vijendra Swarup2, Hursh Naik3, Michael Waters1, Daniel Gonzalez1, Supreet Kaur1, Lynn Ashby1, Patricia Teran4, Tracie Schroeder1, Tiffany Sheehan1, Emily Mawk5, David Wang1
1Barrow Neurological Institute, 2Arizona Heart Rhythm Center, 3St. Joseph's Hospital and Medical Center, 4Privia Health, 5Arizona Cardiovascular Research Center
Objective:
To assess the comparative safety of patent foramen ovale (PFO) closure for secondary stroke prevention in a population of patients aged 60 or older in the United States.
Background:
Paradoxical embolism via PFO is a known etiology of cryptogenic ischemic stroke. RESPECT, DEFENSE-PFO, REDUCE and CLOSE trials showed that closing PFO is superior to medical treatment for stroke prevention in patients younger than 60.
Design/Methods:
This is an IRB approved retrospective review of all patients who underwent PFO closure for secondary stroke prevention by two cardiology services at a comprehensive stroke center. Data reviewed and analyzed included demographics, Spencer grades, TEE and TTE findings, and peri-procedural adverse events. Safety data was compared to the published results of RESPECT and REDUCE trials. Descriptive statistics were applied, and Fisher's Exact Test was used for the comparisons.
Results:
From 1/2021 to 1/2023, data of 24 patients meeting criteria was included in the analysis. They consisted of 9 (38%) male and 4 (17%) Hispanic with average age 69 (range 60-82). Ten (42%) patients had a Spencer Grade 4. The average baseline NIHSS score was 5.7. Atrial fibrillation or flutter was reported in 3 (12.5%) study patients compared to 0.6% in RESPECT (p=0.002) and 6.6% in REDUCE (p=0.224). Other tracked adverse event rates did not significantly differ.
Conclusions:
Our study showed that observed PFO closure adverse event rates in patients age ≥ 60 are statistically indifferent from patients age < 60 except for occurrence of atrial fibrillation. The increased rate of atrial fibrillation may be partly explained by an increased baseline rate of atrial fibrillation and trial variation in arrhythmia monitoring methods. Subsequent prospective RCTs are warranted with post procedural cardiac monitoring for at least 45 days (83% atrial fibrillation or flutter capture in REDUCE) to examine the efficacy and safety of closing PFO in patients > 60.