Implantable cardiac devices with patent foramen ovale—a risk factor for cardioembolic stroke?

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A quarter of patients with implanted cardiac devices have a patent foramen ovale (PFO). Thrombus is frequently noted on intravascular leads that in the presence of a PFO could result in cerebral vascular embolic events. However, whether this mechanism of stroke occurs is not clearly known. We report three patients with PFO, implanted leads with thrombus, and stroke, including a patient where thrombus partially attached to the lead was seen traversing the PFO.

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Fig. 1
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Patent foramen ovale


Atrial fibrillation


Computed tomography


Transesophageal echocardiogram


Coronary artery disease


Coronary artery bypass graft


Implantable cardioverter defibrillator


Left atrial appendage


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Correspondence to Samuel J. Asirvatham.

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Editorial Commentary

This paper describes three patients with systemic embolic events in the setting of documented thrombus on pacemaker or ICD leads. Although the images showing thrombus in a PFO are impressive, the observation in the absence of a denominator still leaves us not knowing how common this combination is, or what to do about it. Although the potential exists for pulmonary or paradoxical embolization of a lead-related thrombus, causality of embolization is far from certain in the majority of cases. How should the finding of lead-related thrombus and a PFO affect clinical decisions? Should the presence of thrombus prompt intervention with anticoagulation or PFO closure? Indeed, we know from papers referenced by the authors that lead-related thrombus is common.

Limitations of the manuscript include the small sample size and important comorbidities including known cerebrovascular disease in patient 3, recent fractures with attendant prothrombotic states in patients 1 and 2, and atrial fibrillation all make a causal relationship of lead-related thrombosis to stroke in these patients uncertain.

Unfortunately, the impact of the presence of both lead-related thrombus and a PFO in individual patients is unstudied. The negative CLOSURE trial is not helpful for guidance here since exclusion criteria for entry into the trial included “any identified potential cause of ischemic stroke or TIA” which would I suspect include thrombus on a pacemaker or ICD lead. Certainly more needs to be learned, and to develop insulation materials that are less thrombogenic desirable. For now, bedside decisions will have to be made on an individual basis perhaps taking into account the size or presence of right-to-left shunting, the morphology (sessile or pedunculated) and size of the thrombus, comorbidities that may make anticoagulation more risky, and local expertise in PFO closure.

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DeSimone, C.V., DeSimone, D.C., Patel, N.A. et al. Implantable cardiac devices with patent foramen ovale—a risk factor for cardioembolic stroke?. J Interv Card Electrophysiol 35, 159–162 (2012).

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  • Stroke
  • Pacemaker defibrillator
  • Intravascular leads
  • Patent foramen ovale
  • Shunt
  • Thrombus