Introduction: Patent foramen ovale (PFO) has been recently implicated as a strong predictor of stroke or transient ischemic attack (TIA) in patients with implanted pacemaker or defibrillation leads. Leads in the right heart can form thrombi that embolize to the pulmonary circulation and raise pulmonary pressure. This increases right-to-left shunting through PFO or intrapulmonary shunts and can result in paradoxical embolism. We sought to determine whether certain lead characteristics confer a higher thrombogenic risk resulting in stroke/TIAs in patients either with or without a PFO.
Methods: We retrospectively analyzed 5,646 patients (mean age 67.3 ± 16.3 years, 64 % male) who had endocardial device leads implanted in 2000-2010. We performed univariate and multivariate-adjusted proportional hazards models to determine association of lead characteristics with stroke/TIA during follow-up.
Results: On univariate analysis, passively fixated tined leads were associated with more stroke/TIAs (HR 1.77, 95 % CI 1.27, 2.47; p<0.001), whereas presence of defibrillation coil was associated with fewer stroke/TIAs (HR 0.59, 95 % CI 0.42-0.84; p=0.003). Number of leads per patient, presence of atrial lead, maximum lead size, tip shape, and type of insulating material were not associated with stoke/TIA. On multivariate analyses adjusting for age, sex, diagnosis of PFO, and prior history of stroke/TIA, the presence of tined leads was associated with stroke/TIA (HR 1.41, 95 % CI 1.00-1.97; p=0.049). Defibrillation coils were no longer associated with lower stroke/TIA on multivariate analysis.
Conclusions: Most physical characteristics of contemporary leads do not impact rate of stroke/TIA among patients receiving implantable devices. The presence of a PFO is a major risk factor for stroke/TIA in patients with endovascular leads.