The Risk of Heart Failure Progression in Patients With Patent Foramen Ovale: Differential Risk Associated With Device Closure

Background: A patent foramen ovale (PFO) can unload left atrial pressure via an interatrial shunt. We investi-gated whether device closure of PFO is associated with a subsequent risk of heart failure (HF), particularly in patients with structural heart disease or atrial fibrillation (AF).Methods: We enrolled 4,804 consecutive patients who underwent transesophageal echocardiography at ter-tiary medical centers in Korea between 2007 and 2019. The primary outcome was the 4-year risk of HF hos-pitalization. Underlying structural heart disease was determined by echocardiography.Results: A PFO was observed in 981 (20.4%) patients, where 161 underwent device closure. During follow-up (median, 3.5 [1.4-6.4] years), the primary outcome was lower in patients with PFO than in those without (2.6% vs 4.0%; adjusted hazard ratio [aHR], 0.65; 95% CI, 0.45-0.94; P = .021). Among the patients with PFO, the primary outcome was higher in the device closure group than in the no-closure group (5.5% vs 1.2%; aHR, 5.59; 95% CI, 4.26-7.34; P < .001). A consistent result was found in patients with structural heart disease or AF (9.6% vs 3.9%; aHR, 2.55; 95% CI, 1.95-3.33; P < .001), demonstrating an increased risk of the primary outcome proportionate to the number of combined structural abnormalities. However, no significant associ-ation was observed between the primary outcome and PFO closure in those without structural heart disease or AF (1.7% vs 1.5%; aHR, 1.22; 95% CI, 0.99-1.50; P = .054). Conclusion: Patients with underlying structural heart disease or AF may be predisposed to symptomatic HF progression after PFO closure. Therefore, careful medical surveillance with optimal risk management is needed in these patients.