Endocardial Device Leads in Patients with Patent Foramen Ovale: Echocardiographic Correlates of Stroke/TIA and Mortality

Background: Echocardiographically detected patent foramen ovale (PFO) has been associated with stroke/transient ischemic attack (TIA) in patients with cardiac implantable electronic devices (CIEDs). We sought to evaluate the relationship between echocardiographic characteristics and risk of stroke/TIA and mortality in CIED patients with PFO. Methods: In 6,086 device patients, PFO was detected in 319 patients. A baseline echocardiogram was present in 250 patients, with 186 having a follow-up echocardiogram. Results: Of 250 patients with a baseline echocardiogram, 9.6% (n = 24) had a stroke/TIA during mean follow-up of 5.3 ± 3.1 years; and 42% (n = 105) died over 7.1 ± 3.7 years. Atrial septal aneurysm, prominent Eustachian valve, visible shunting across PFO, baseline or change in estimated right ventricular systolic pressure (RVSP)/tricuspid regurgitation (TR), or maximum RVSP were not associated with postimplant stroke/TIA (P > 0.05). An exploratory multivariate analysis using time-dependent Cox models showed increased hazard of death in patients with increase in TR ≥2 grades (hazard ratio [HR] 1.780, 95% confidence interval [CI] 1.447–2.189, P < 0.0001), or increase in RVSP by >10 mm Hg (HR 2.018, 95% CI 1.593–2.556, P < 0.0001), or maximum RVSP in follow-up (HR 1.432, 95% CI 1.351–1.516, P < 0.0001). A significant increase (P < 0.001) in TR was also noted during follow-up. Conclusions: In patients with CIED and PFO, structural and hemodynamic echocardiographic markers did not predict future stroke/TIA. However, a significantly higher TR or RVSP was associated with higher mortality.