title: The increased risk of stroke/transient ischemic attack in women with a cardiac implantable electronic device is not associated with a higher atrial fibrillation burden.
abstract: OBJECTIVE
  To evaluate if the increased thromboembolic risk in female patients may be related to a higher burden of atrial fibrillation (AF).
  
  
  RESULTS
  Data collected in a prospective observational research of patients implanted with a cardiac implantable electrical device (CIED) were analysed. We included 2398 patients: 489 (20.4%) were female and 1909 (79.6%) were male (oral anticoagulants treatment in 23.2%, independent of gender). During the follow-up (mean 42.8, median 37.7 months), 26 thromboembolic events occurred in 22 patients, with an incidence rate ratio of both stroke and stroke/transient ischemic attack (TIA) significantly higher in females compared with males [2.00, 95% confidence interval (CI) 1.53-2.61, P< 0.001 for stroke; 1.77 (95% C1.37-2.31, P< 0.001 for stroke/TIA]. An AF burden ≥5 min was a common finding (44% of patients), with no difference between men and women. The maximum daily AF burden and the time to evolution in permanent AF did not differ according to gender. The results of multivariate Cox regression showed that female gender, as well as history of CABG, were significant independent predictors of stroke and female gender was also an independent predictor of stroke/TIA.
  
  
  CONCLUSIONS
  Among patients implanted with a CIED, an AF burden of at least 5 min is a common finding, (44% of patients). Female patients have a risk of stroke and TIAs that is around two-fold that of male patients, but this increased risk cannot be ascribed to a higher burden of AF or to differences in the evolution to permanent AF.
  
  
  BACKGROUND
  ClinicalTrials.gov Identifier: NCT01007474.
authors.affiliation: Cardiology Division, Department of Diagnostics, Clinical and Public Health Medicine, University of Modena and Reggio Emilia, Policlinico di Modena, Modena, Italy.|Department of Experimental, Diagnostic and Specialty Medicine, Institute of Cardiology, University of Bologna, S. Orsola-Malpighi University Hospital, Bologna, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Boriani
authors.affiliation: University of Birmingham Centre for Cardiovascular Sciences, City Hospital, Birmingham, UK.|Aalborg Thrombosis Research Unit, Department of Clinical Medicine, Aalborg University, Aalborg, Denmark.
authors.forename: Gregory Y H
authors.initials: GYH
authors.lastname: Lip
authors.affiliation: Cardiology Division, San Filippo Neri Hospital, Roma, Italy.
authors.forename: Renato Pietro
authors.initials: RP
authors.lastname: Ricci
authors.affiliation: Cardiology Division, S. Maria della Misericordia Hospital, Udine; Italy.
authors.forename: Alessandro
authors.initials: A
authors.lastname: Proclemer
authors.affiliation: Cardiology Division, Fondazione Policlinico S. Matteo IRCCS, Pavia, Italy.|Cardiology Division, Ospedale Maggiore, Crema (Cremona), Italy.
authors.forename: Maurizio
authors.initials: M
authors.lastname: Landolina
authors.affiliation: Cardiology Division, Niguarda Ca' Granda Hospital, Milano, Italy.
authors.forename: Maurizio
authors.initials: M
authors.lastname: Lunati
authors.affiliation: Cardiology, University of Firenze, Italy.|IRCCS Multimedica, Milano, Italy.
authors.forename: Luigi
authors.initials: L
authors.lastname: Padeletti
authors.affiliation: Mater Salutis Hospital, Legnago (Verona), Italy.
authors.forename: Gabriele
authors.initials: G
authors.lastname: Zanotto
authors.affiliation: Department of Cardiology, Sacro Cuore Hospital, Negrar, Verona, Italy.
authors.forename: Giulio
authors.initials: G
authors.lastname: Molon
authors.affiliation: Department of Experimental, Diagnostic and Specialty Medicine, Institute of Cardiology, University of Bologna, S. Orsola-Malpighi University Hospital, Bologna, Italy.
authors.forename: Mauro
authors.initials: M
authors.lastname: Biffi
authors.affiliation: Cardiology Division, Fondazione Policlinico S. Matteo IRCCS, Pavia, Italy.
authors.forename: Roberto
authors.initials: R
authors.lastname: Rordorf
authors.affiliation: Division of Cardiology, Arcispedale S. Maria Nuova, Reggio Emilia, Italy.
authors.forename: Fabio
authors.initials: F
authors.lastname: Quartieri
authors.affiliation: IRCCS Istituto Clinico Humanitas, Rozzano (Milano), Italy.
authors.forename: Maurizio
authors.initials: M
authors.lastname: Gasparini
mesh_terms: D000284:Administration, Oral; D000368:Aged; D000925:Anticoagulants / Q000008:administration & dosage; D001281:Atrial Fibrillation / Q000175:diagnosis / Q000188:drug therapy / Q000453:epidemiology*; D058406:Cardiac Resynchronization Therapy / Q000009:adverse effects; D058409:Cardiac Resynchronization Therapy Devices / Q000009:adverse effects; D016009:Chi-Square Distribution; D001026:Coronary Artery Bypass / Q000009:adverse effects; D017147:Defibrillators, Implantable / Q000009:adverse effects; D004554:Electric Countershock / Q000009:adverse effects / Q000295:instrumentation*; D005260:Female; D006333:Heart Failure / Q000175:diagnosis / Q000453:epidemiology / Q000628:therapy*; D006801:Humans; D015994:Incidence; D002546:Ischemic Attack, Transient / Q000175:diagnosis / Q000453:epidemiology* / Q000517:prevention & control; D007558:Italy / Q000453:epidemiology; D053208:Kaplan-Meier Estimate; D008875:Middle Aged; D015999:Multivariate Analysis; D016016:Proportional Hazards Models; D011446:Prospective Studies; D018570:Risk Assessment; D012307:Risk Factors; D012720:Severity of Illness Index; D012737:Sex Factors; D020521:Stroke / Q000175:diagnosis / Q000453:epidemiology* / Q000517:prevention & control; D013997:Time Factors
chemical_list: D000925:Anticoagulants
keywords: Anticoagulation; Atrial fibrillation; Implantable defibrillator; Pacemaker; Stroke