Stroke or transient ischemic attack in patients with transvenous pacemaker or defibrillator and echocardiographically detected patent foramen ovale.
BACKGROUND
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.


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 PFOs in patients who require cardiac implantable electronic devices; if a PFO is detected, PFO closure, anticoagulation, or nonvascular lead placement may be considered.
Department of Internal Medicine, Mayo Clinic, Rochester, MN (C.V.D, D.C.D, C.A.A, V.R.V.); Division of Cardiovascular Diseases, Mayo Clinic, Rochester, MN (C.V.D, P.A.F., M.J.A, S.J.A.); Division of Cardiology, Cedars-Sinai Medical Center, Los Angeles, CA (A.N.); Mayo Medical School, Rochester, MN (N.A.P.); Mayo Graduate School of Medicine Visiting Scholars Program, Mayo Clinic, Rochester, MN (S.B.); Department of Statistics, Mayo Clinic, Rochester, MN (J.P.S., D.O.H.); Department of Pediatrics and Adolescent Medicine Mayo Clinic, Rochester, MN (M.J.A., S.J.A.); and Department of Neurology, Mayo Clinic, Rochester, MN (A.A.R.).
Christopher V
CV
DeSimone
Paul A
PA
Friedman
Amit
A
Noheria
Nikhil A
NA
Patel
Daniel C
DC
DeSimone
Sami
S
Bdeir
Christopher A
CA
Aakre
Vaibhav R
VR
Vaidya
Joshua P
JP
Slusser
David O
DO
Hodge
Michael J
MJ
Ackerman
Alejandro A
AA
Rabinstein
Samuel J
SJ
Asirvatham
D000368:Aged; D000369:Aged, 80 and over; D015331:Cohort Studies; D017147:Defibrillators, Implantable; D017548:Echocardiography, Transesophageal; D005260:Female; D005500:Follow-Up Studies; D054092:Foramen Ovale, Patent / Q000000981:diagnostic imaging* / Q000453:epidemiology* / Q000628:therapy; D006801:Humans; D002546:Ischemic Attack, Transient / Q000000981:diagnostic imaging / Q000453:epidemiology*; D008297:Male; D008875:Middle Aged; D010138:Pacemaker, Artificial; D012189:Retrospective Studies; D020521:Stroke / Q000000981:diagnostic imaging / Q000453:epidemiology*; D015996:Survival Rate / Q000639:trends
International Classification of Diseases; defibrillators; foramen ovale, patent; ischemic attack, transient; pacemaker, artificial; stroke