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

Abstract

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.