Background: The long-term safety of patent foramen ovale (PFO) closure following stroke or transient ischemic attack (TIA) is uncertain. We sought to evaluate the long-term risk of complications following endovascular PFO closure in a large, heterogeneous group of patients with cerebrovascular disease.
Methods: We performed a retrospective cohort study using administrative claims data on all acute care hospitalizations from 2005-2011 in California, 2006-2013 in New York, and 2005-2013 in Florida. Using ICD-9-CM codes, we identified patients without other forms of congenital heart disease who underwent endovascular PFO closure within 1 year of a stroke or TIA. The primary outcome was a serious complication, defined as in prior studies as atrial fibrillation, cardiac tamponade, pneumothorax, hemothorax, a vascular access complication, or death. Kaplan-Meier survival analysis was used to calculate the cumulative rate of complications. In a secondary analysis, we included other serious complications described in previous randomized trials of PFO closure after stroke: venous thromboembolism, ventricular arrhythmia, infective endocarditis, and sepsis.
Results: We identified 1,887 patients who underwent PFO closure after stroke or TIA, among whom the mean age at the time of closure was 54.2 (±14.3) years. By 7 years, the cumulative rate of any complication or death was 18.3% (95% confidence interval [CI], 15.9-21.0%). The mortality rate was 3.4% (95% CI, 2.5-4.6%). Atrial fibrillation was the most common complication, occurring in 8.3% (95% CI, 7.1-9.5%) of patients. The rate of any complication during the index hospitalization for PFO closure was 7% (95% CI, 5.8-8.1%). When venous thromboembolism, ventricular arrhythmia, infective endocarditis, and sepsis were included, the cumulative rate of any complication or death throughout follow-up was 21.4% (95% CI, 19.0-24.0%).
Conclusions: Approximately 1 in 5 patients who undergo PFO closure after stroke or TIA experience a serious complication or death within 7 years.