15% of patients within 2 weeks of device implantation without heparin prophylaxis, 8 and, at autopsy, pulmonary emboli were present in 21% of patients with CIEDs. 6 A study using intracardiac echocardiography at the time of a planned electrophysiological procedure found mobile thrombi attached to leads in 30% of patients. 9 These thrombi were rarely seen with the use of transthoracic echocardiography (TTE), reflecting their small size. Moreover, the presence of lead-related thrombi was associated with increased pulmonary artery systolic pressure, suggesting subclinical pulmonary embolic events.9 Elevated pulmonary artery pressures may in turn increase the likelihood of right-to-left shunting across a patent foramen ovale (PFO).
Clinical Perspective on p 1441Background-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 Up to 25% of the population may have a PFO detectable on autopsy, with persistence after the birth of a connection between the right and left atria. 10,11 In patients with elevated right-sided pressures, flow through a PFO provides a mechanism of blood flow from the right heart to the left-sided circulation. In patients with a PFO, endovascular leads may pose a unique hazard, because the thrombi that develop on leads may shunt across the PFO to the systemic circulation, resulting in ischemic cerebrovascular events or other systemic thromboembolisms. We have previously published 2 case series on device...