Risk of Cerebrovascular Events in Patients With Patent Foramen Ovale and Intracardiac Devices

Study Questions:

Do patients with patent foramen ovale (PFO) have an increased risk of stroke due to permanent pacemaker (PPM)/implantable cardioverter-defibrillator (ICD) implantation?


A total of 2,921 consecutive patients with PFO were identified from the Cleveland Clinic echocardiography database. These patients were divided into a device group (patients had PPM/ICD implantation for any reason after receiving a diagnosis of PFO) and a no device group (patients did not have PPM or ICD implantation). Patients who had PFO closure during follow-up were excluded. Both groups were matched for baseline characteristics and medications. The incidence of ischemic stroke was assessed in each group after propensity score matching (case:control ratio of 1:1 yielding 231 pairs). All patients completed at least 4 years of follow-up.


There were 2,690 patients in the no device group (67 ± 16 years of age, 52% male) and 231 patients in the device group (75 ± 15 years of age, 59% male). Six patients (2.6%) in the no device group and six (2.6%) in the device group had a stroke during the follow-up period. No difference in the rate of stroke, transient ischemic stroke, or stroke/transient ischemic stroke was observed between the two groups.


The authors concluded that the risk of stroke in patients with PFO and an implantable intracardiac device is similar to those without an intracardiac device.


PFO has been associated with cryptogenic stroke in younger adults. Given the large number of patients (usually much older) undergoing cardiac device implantation, the theoretical risk of thrombus formation leading to paradoxical embolism and stroke could be significant. According to the present study, there does not appear to be an association between implantable intracardiac devices and stroke in patients with PFO. In this study, 19 of the 22 strokes/transient ischemic strokes occurred in patients with atrial fibrillation.

Clinical Topics: Arrhythmias and Clinical EP, Congenital Heart Disease and Pediatric Cardiology, Noninvasive Imaging, Implantable Devices, SCD/Ventricular Arrhythmias, Atrial Fibrillation/Supraventricular Arrhythmias, Congenital Heart Disease, CHD and Pediatrics and Arrhythmias, CHD and Pediatrics and Imaging, CHD and Pediatrics and Quality Improvement, Echocardiography/Ultrasound

Keywords: Stroke, Follow-Up Studies, Propensity Score, Atrial Fibrillation, Foramen Ovale, Patent, Embolism, Paradoxical, Defibrillators, Implantable, Echocardiography

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