Stroke or transient ischemic attack in patients with transvenous pacemaker or defibrillator and echocardiographically...

Area of Science:

• Cardiology
• Neurology
• Medical Devices

Background:

• Patent foramen ovale (PFO) can allow paradoxical embolism of thrombi from right-sided cardiac chambers.
• Thrombi may accumulate on leads of cardiac implantable electronic devices (CIEDs).
• The association between PFO and stroke/TIA in CIED patients is not well-established.

Purpose of the Study:

• To determine if PFO increases the risk of stroke/transient ischemic attack (TIA) in patients with endocardial leads.
• To evaluate the impact of PFO on mortality in this patient population.

Main Methods:

• Retrospective cohort study of patients with endocardial leads implanted between 2000-2010.
• Echocardiography used to identify PFO status.
• Cox proportional hazards models used to compare stroke/TIA and mortality between PFO and non-PFO groups.
• Multivariable adjustment for clinical risk factors.

Main Results:

• 6075 patients analyzed (364 with PFO).
• Higher incidence of stroke/TIA in PFO patients (8.2% vs 2.0%).
• PFO remained a significant independent predictor of stroke/TIA (aHR 3.30).
• No significant difference in all-cause mortality between groups.

Conclusions:

• PFO is associated with a substantially increased risk of embolic stroke/TIA in patients with endocardial leads.
• Screening for PFO in patients requiring CIEDs is suggested.
• Consideration of PFO closure, anticoagulation, or nonvascular leads for PFO-positive patients.