Hypothesis: To evaluate the risk of stroke in patients with known patent foramen ovale (PFO) undergoing implantation of intracardiac devices
Background: The risk of stroke in patients with known PFO undergoing implantation of intracardiac devices like permanent pacemaker (PPM) or implantable cardioverter-defibrillator (ICD) is not known
Methods: We retrospectively identified all consecutive patients (n= 7893) with PFO within a large health care network of hospitals with common electronic medical records. Patients who underwent intracardiac device (PPM/ICD) implantation were included in the device group (n= 367) and rest in no-device group (n=7526). Patients were followed for up to 10 years.
Results: In unadjusted analysis, 1636 (21.7%) patients in no-device group and 163 (44.4%) patients in device group had a stroke in follow up (HR 2.70, 95% CI 2.26- 3.23, p<0.001; Figure 1). In adjusted multivariate analysis, the risk of having a stroke was similar for both groups (HR 0.93, 95%CI 0.72- 1.12; p= 0.55, after adjusting for baseline characteristics including age, gender, diabetes, congestive heart failure, prior stroke and hypertension).
Conclusion: Patients with known patent foramen ovale who undergo an intracardiac device (PPM/ICD) implantation have a similar risk of stroke compared to those without the intracardiac device.