Abstract 11586: Patent Foramen Ovale is Associated with Increased Incidence of Stroke/TIA in Patients with Endocardially Implanted Device Leads
Introduction: Pacemakers, defibrillators and resynchronization devices require implanting endocardial leads into the right atrium, right ventricle, or coronary sinus. These leads are known to accumulate thrombus. A patent foramen ovale (PFO) may permit arterial embolization of thrombi. Therefore, we sought to determine whether the presence of a PFO increases the risk of stroke/TIA in patients with endocardial leads.
Methods: The retrospective study cohort included all patients with endocardial leads implanted from Jan 1, 2000 to Oct 25, 2010 at Mayo Clinic, Rochester. PFO found on any echocardiogram in the patient’s records delineated PFO (PFO+) and non-PFO (PFO-) cohorts. The primary endpoint was the occurrence of a stroke/TIA during post-implantation follow-up. Cox proportional-hazards models were used to obtain unadjusted and multivariable-adjusted (using stepwise selection) hazard ratios (HR, 95% CI) of stroke/TIA in PFO+ vs. PFO-.
Results: We followed 6086 patients including 375 with PFO for 4.7±3.1 years. PFO+ and PFO- were similar with respect to age, sex, hypertension, hyperlipidemia, diabetes, CAD, CVD, CHF, atrial fibrillation and CHA2DS2-VASc score (all p>0.05). The primary endpoint of stroke/TIA was met in 41/375 (10.9%) PFO+ vs.117/5711 (2.0%) PFO- (HR 4.72, 3.30-6.76; p<0.0001; Figure). The association of PFO+ with stroke/TIA remained significant after multivariable adjustment for age, sex and history of stroke/TIA (HR 4.47, 3.12-6.41; p<0.0001).
Conclusion: In patients with endocardial leads, the presence of a PFO is associated with a higher risk of stroke/TIA. This suggests a role for screening patients with cardiac devices for PFO, and if present, consideration of closure, anticoagulation, or epicardial lead placement. This study advocates for a prospective trial to establish optimal management of patients with PFO and endocardial leads.
- © 2012 by American Heart Association, Inc.