Stroke or Transient Ischemic Attack in Patients with Transvenous Pacemaker or Defibrillator and Echocardiographically Detected Patent Foramen Ovale
Background—A patent foramen ovale (PFO) may permit arterial embolization of thrombi that accumulate on leads of cardiac implantable electronic devices (CIED) in the right-sided cardiac chambers. We sought to determine whether a PFO increases the risk of stroke/transient ischemic attack (TIA) in patients with endocardial leads.
Methods and Results—We retrospectively evaluated all patients who had endocardial leads implanted between January 1, 2000, and October 25, 2010, at Mayo Clinic Rochester. Echocardiography was used to establish definite PFO and non-PFO cohorts. The primary endpoint of stroke/TIA consistent with a cardioembolic etiology, and the secondary endpoint of mortality during post-implantation followup were compared in PFO vs. non-PFO patients using Cox proportional hazards models. We analyzed 6075 patients (364 with PFO) followed for mean 4.7 ± 3.1 years. The primary endpoint of stroke/TIA was met in 30/364 (8.2%) PFO vs. 117/5711 (2.0%) non-PFO patients (hazard ratio: 3.49, 95% CI 2.33-5.25, p<0.0001). The association of PFO with stroke/TIA remained significant after multivariable adjustment for age, sex, history of stroke/TIA, atrial fibrillation, and baseline aspirin/warfarin use (hazard ratio: 3.30, 95% CI 2.19-4.96, p<0.0001). There was no significant difference in all-cause mortality between PFO and non-PFO patients (hazard ratio: 0.91, 95% CI 0.77-1.07, p=0.25).
Conclusions—In patients with endocardial leads, the presence of a PFO on routine echocardiography is associated with a substantially increased risk of embolic stroke/TIA. This finding suggests a role of screening for PFOs in patients who require CIEDs, if detected, PFO closure, anticoagulation, or non-vascular lead placement may be considered.
- Received May 8, 2013.
- Revision received July 18, 2013.
- Accepted August 5, 2013.