title: Risk of cerebrovascular events in patients with patent foramen ovale and intracardiac devices.
abstract: OBJECTIVE
  This study investigated whether patients with patent foramen ovale (PFO) have an increased risk of stroke due to permanent pacemaker (PPM)/implantable cardioverter-defibrillator (ICD) implantation.
  
  
  BACKGROUND
  Data are lacking on the risk of stroke in patients with PFO and implantable intracardiac devices, either a PPM or an ICD. We investigated whether patients with PFO have increased risk of stroke due to PPM/ICD implantation.
  
  
  METHODS
  Between 2001 and 2008, 2,921 consecutive patients with PFO (67.5 ± 16.4 years of age, 52.2% male) were identified from our echocardiography database. These patients were divided into a device group (patients had PPM/ICD implantation for any reason after receiving a diagnosis of PFO) and a no device group (patients did not have PPM or ICD implantation). Patients who had PFO closure during follow-up were excluded. Both groups were matched for baseline characteristics and medications. The incidence of ischemic stroke was assessed in each group after propensity score matching (case:control ratio of 1:1 yielding 231 pairs). All patients completed at least 4 years of follow-up until May 2012.
  
  
  RESULTS
  There were 2,690 patients in the n device group (67.3 ± 16.4 years of age, 51.6% male) and 231 patients in the device group (75.4 ± 14.6 years of age, 59.3% male). Six patients (2.6%) in the no device group and 6 (2.6%) in the device group had a stroke during the follow-up period. No difference in the rate of stroke, transient ischemic stroke, or stroke/transient ischemic stroke was observed between the 2 groups.
  
  
  CONCLUSIONS
  The risk of stroke in patients with PFO and an implantable intracardiac device is similar to those without an intracardiac device. In patients with PFO, without a history of stroke, device implantation might not be considered a risk factor for future stroke occurrence.
authors.affiliation: Department of Cardiovascular Medicine, Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio.
authors.forename: Kanhaiya L
authors.initials: KL
authors.lastname: Poddar
authors.affiliation: Department of Internal Medicine, Medicine Institute, Cleveland Clinic, Cleveland, Ohio.
authors.forename: Vijaiganesh
authors.initials: V
authors.lastname: Nagarajan
authors.affiliation: Department of Cardiovascular Medicine, Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio.
authors.forename: Amar
authors.initials: A
authors.lastname: Krishnaswamy
authors.affiliation: Department of Internal Medicine, Medicine Institute, Cleveland Clinic, Cleveland, Ohio.
authors.forename: Navkaranbir S
authors.initials: NS
authors.lastname: Bajaj
authors.affiliation: Department of Cardiovascular Medicine, Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio.
authors.forename: Meera
authors.initials: M
authors.lastname: Kumari
authors.affiliation: Department of Cardiovascular Medicine, Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio.
authors.forename: Hazem
authors.initials: H
authors.lastname: Bdair
authors.affiliation: Department of Cardiovascular Medicine, Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio.
authors.forename: Dhruv
authors.initials: D
authors.lastname: Modi
authors.affiliation: Department of Cardiovascular Medicine, Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio.
authors.forename: Shikhar
authors.initials: S
authors.lastname: Agarwal
authors.affiliation: Department of Cardiovascular Medicine, Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio.
authors.forename: Sachin S
authors.initials: SS
authors.lastname: Goel
authors.affiliation: Department of Internal Medicine, Medicine Institute, Cleveland Clinic, Cleveland, Ohio.
authors.forename: Akhil
authors.initials: A
authors.lastname: Parashar
authors.affiliation: Department of Cardiovascular Medicine, Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio.
authors.forename: E Murat
authors.initials: EM
authors.lastname: Tuzcu
authors.affiliation: Department of Cardiovascular Medicine, Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio. Electronic address: kapadis@ccf.org.
authors.forename: Samir R
authors.initials: SR
authors.lastname: Kapadia
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D002545:Brain Ischemia / Q000175:diagnosis / Q000453:epidemiology*; D002304:Cardiac Pacing, Artificial / Q000009:adverse effects*; D015897:Comorbidity; D016208:Databases, Factual; D017147:Defibrillators, Implantable / Q000009:adverse effects*; D004554:Electric Countershock / Q000009:adverse effects* / Q000295:instrumentation; D005260:Female; D054092:Foramen Ovale, Patent / Q000175:diagnosis / Q000453:epidemiology*; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D009820:Ohio / Q000453:epidemiology; D010138:Pacemaker, Artificial / Q000009:adverse effects*; D012189:Retrospective Studies; D018570:Risk Assessment; D012307:Risk Factors; D020521:Stroke / Q000175:diagnosis / Q000453:epidemiology*; D013997:Time Factors
keywords: intracardiac defibrillator; intracardiac device; ischemic stroke; pacemaker; patent foramen ovale; transient ischemic attack/stroke