Artificial intelligence-enabled electrocardiogram (AI-ECG) does not predict atrial fibrillation following patent foramen ovale closure

Background: Atrial fibrillation (AF) is a known complication following patent foramen ovale (PFO) closure. AI-enabled ECG (AI-ECG) acquired during normal sinus rhythm has been shown to identify individuals with AF by noting high-risk ECG features invisible to the human eye. We sought to characterize the value of AI-ECG in predicting AF development following PFO closure and investigate key clinical and procedural characteristics possibly associated with post-procedural AF. Methods: We performed a retrospective analysis of patients who underwent PFO closure at our hospital from January 2011 to December 2022. We recorded the probability (%) of AF using the Mayo Clinic AI-ECG dashboard from pre- and post-procedure ECGs. The cut-off point of ≥ 11 %, which was found to optimally balance sensitivity and specificity in the original derivation paper (the Youden index) was used to label an AI-ECG “positive” for AF. Pre-procedural transesophageal echocardiography (TEE) and pre- and post-procedure transcranial doppler (TCD) data was also recorded. Results: Out of 93 patients, 49 (53 %) were male, mean age was 55 ± 15 years with mean post-procedure follow up of 29 ± 3 months. Indication for PFO closure in 69 (74 %) patients was for secondary prevention of transient ischemic attack (TIA) and/or stroke. Twenty patients (22 %) developed paroxysmal AF post-procedure, with the majority within the first month post-procedure (15 patients, 75 %). Patients who developed AF were not significantly more likely to have a positive post-procedure AI-ECG than those who did not develop AF (30 % AF vs 27 % no AF, p = 0.8). Based on the PFO-Associated Stroke Causal Likelihood (PASCAL) classification, patients who had PFO closure for secondary prevention of TIA and/or stroke in the “possible” group were significantly more likely to develop AF than patients in “probable” and “unlikely” groups (p = 0.034). AF-developing patients were more likely to have post-procedure implantable loop recorder (ILR) (55 % vs 9.6 %, p < 0.001), and longer duration of ILR monitoring (121 vs 92.5 weeks, p = 0.035). There were no significant differences in TCD and TEE characteristics, device type, or device size between those who developed AF vs those who did not. Conclusions: In this small, retrospective study, AI-ECG did not accurately distinguish patients who developed AF post-PFO closure from those who did not. Although AI-ECG has emerged as a valuable tool for risk prediction of AF, extrapolation of its performance to procedural settings such as PFO closure requires further investigation.