PFO Device Complications: Literature Review and Possible Implications for Echocardiographic Follow‐Up.

Introduction: Transthoracic (TTE) follow up guidelines after PFO device closure are vague. The primary goal of this study was to perform a literature search to characterize the timing of complications that occur after PFO device placement to determine the utility of long‐term routine TTE. Methods: A search was performed in Medline (PubMed) with English language and publication date (2000–2023) filters were applied. Studies were included if they reported on patients who underwent a PFO device closure. Studies were excluded if they only reported on ASD device closure patients, were meta‐analysis or review papers, or did not report any outcomes for the PFO device procedure. Results: A total of 305 articles met the criteria (observational cohort study, n = 196; case study, n = 99; and randomized control study, n = 10). Age at the time of PFO device closure was 47.5 ± 9.3 years. The incidence of complications was 6.9% (3358/48 348). Maximum range of follow‐up was 0–17 years. The plurality of complications was due to arrhythmias (46.3%, 1554/3358), followed by residual shunts (29.7%, 999/3358). The majority of complications occurred ≤6 months post‐device placement (57.8%, 1941/3358). Only 0.8% (27/3358) of complications took place >5 years. All patients with complications >5 years of device placement were presented with clinical symptoms related to their complications. Conclusion: The incidence of patients presenting with PFO‐reported complications beyond 5 years post‐procedure diminished. The utility of routine TTE beyond 5 years post‐PFO after device placement should be further assessed. [ABSTRACT FROM AUTHOR]