Stroke or transient ischemic attack in patients with transvenous pacemaker or defibrillator and echocardiographically detected patent foramen ovale

Christopher V. Desimone, Paul A. Friedman, Amit Noheria, Nikhil A. Patel, Daniel C. Desimone, Sami Bdeir, Christopher A. Aakre, Vaibhav R. Vaidya, Joshua P. Slusser, David O. Hodge, Michael J. Ackerman, Alejandro A. Rabinstein, Samuel J. Asirvatham

Research output: Contribution to journalArticlepeer-review

80 Scopus citations


BACKGROUND - : A patent foramen ovale (PFO) may permit arterial embolization of thrombi that accumulate on the leads of cardiac implantable electronic devices 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 end point of stroke/TIA consistent with a cardioembolic etiology and the secondary end point of mortality during postimplantation follow-up were compared in PFO versus non-PFO patients with the use of Cox proportional hazards models. We analyzed 6075 patients (364 with PFO) followed for a mean 4.7±3.1 years. The primary end point of stroke/TIA was met in 30/364 (8.2%) PFO versus 117/5711 (2.0%) non-PFO patients (hazard ratio, 3.49; 95% confidence interval, 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% confidence interval, 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% confidence interval, 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 cardiac implantable electronic devices; if a PFO is detected, PFO closure, anticoagulation, or nonvascular lead placement may be considered.

Original languageEnglish
Pages (from-to)1433-1441
Number of pages9
Issue number13
StatePublished - Sep 24 2013


  • Defibrillators
  • International Classification of Diseases
  • artificial
  • foramen ovale
  • ischemic attack, transient
  • pacemaker
  • patent
  • stroke


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