title: Stroke incidence in patients with cardiac implantable electronic devices remotely controlled with automatic alerts of atrial fibrillation. A sub-analysis of the HomeGuide study.
abstract: BACKGROUND
  Remote Monitoring (RM) of cardiac implantable electronic devices (CIEDs) is recommended in management of Atrial Fibrillation (AF), which is a recognized risk factor for thromboembolism. We tried to elucidate whether stroke incidence observed in a large, remotely monitored population was consistent with the CHA2DS2VASc risk profile.
  
  
  METHODS
  Data from 1650 patients [76% male, age 72 (63-68), CHA2DS2VASc score 3.0 (2.0-4.0)] enrolled during the HomeGuide study and monitored with a daily-transmission RM system providing automatic alerts for AF, were analysed. Of those, 25% had a pacemaker and 75% an implantable cardioverter defibrillator with or without cardiac resynchronization. Estimations of the expected thromboembolic events were based on the population CHA2DS2VASc score profile used in a computer-simulated Markov model.
  
  
  RESULTS
  Eight thromboembolic events were observed with a 4-year cumulative stroke rate of 0.8% (confidence interval, 0.4%-1.5%). Simulations returned from 18.7 to 17.1 expected events, depending on the AF duration assumed to trigger anticoagulation (one-sample log-rank p<0.03). During the study period, 681 (84%) AF episodes and 129 (16%) atrial tachycardias were detected in 291 patients (18%): 93% of episodes were detected remotely in 269 patients, 66% of whom had no history of AF. Medical interventions were necessary in 305 episodes, 85% of which were detected remotely. Reaction time was 1 (0-6) days for remotely-detected episodes and 33 (14-121) days for episodes detected in clinic (p<0.0001).
  
  
  CONCLUSIONS
  In a large CIED population followed remotely for up to 4years, the incidence of thromboembolic events was less than half the estimations based on the CHA2DS2VASc risk profile.
authors.affiliation: San Filippo Neri Hospital, Rome, Italy. Electronic address: renatopietroricci@tin.it.
authors.forename: Renato Pietro
authors.initials: RP
authors.lastname: Ricci
authors.affiliation: Civil Hospital, Montebelluna, Italy.
authors.forename: Diego
authors.initials: D
authors.lastname: Vaccari
authors.affiliation: San Filippo Neri Hospital, Rome, Italy.
authors.forename: Loredana
authors.initials: L
authors.lastname: Morichelli
authors.affiliation: Mater Salutis Hospital, Legnago, Italy.
authors.forename: Gabriele
authors.initials: G
authors.lastname: Zanotto
authors.affiliation: Casilino Hospital, Rome, Italy.
authors.forename: Leonardo
authors.initials: L
authors.lastname: Calò
authors.affiliation: V. Monaldi Hospital, Naples, Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: D'Onofrio
authors.affiliation: Spedali Civili, Brescia, Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: Curnis
authors.affiliation: Vito Fazzi Hospital, Lecce, Italy.
authors.forename: Ennio C L
authors.initials: EC
authors.lastname: Pisanò
authors.affiliation: Civil Hospital, Portogruaro, Italy.
authors.forename: René
authors.initials: R
authors.lastname: Nangah
authors.affiliation: Santa Maria degli Angeli Hospital, Pordenone, Italy.
authors.forename: Marco
authors.initials: M
authors.lastname: Brieda
authors.affiliation: Cà Foncello Hospital, Treviso, Italy.
authors.forename: Vittorio
authors.initials: V
authors.lastname: Calzolari
authors.affiliation: F. Ferrari Hospital, Casarano, Italy.
authors.forename: Donato
authors.initials: D
authors.lastname: Melissano
authors.affiliation: Clinical Department, BIOTRONIK Italy, Vimodrone, Italy.
authors.forename: Nicola
authors.initials: N
authors.lastname: Rovai
authors.affiliation: Clinical Department, BIOTRONIK Italy, Vimodrone, Italy.
authors.forename: Alessio
authors.initials: A
authors.lastname: Gargaro
mesh_terms: D000368:Aged; D001281:Atrial Fibrillation / Q000175:diagnosis / Q000453:epidemiology* / Q000503:physiopathology; D058409:Cardiac Resynchronization Therapy Devices / Q000639:trends*; D017147:Defibrillators, Implantable / Q000639:trends*; D015716:Electrocardiography, Ambulatory / Q000379:methods / Q000639:trends*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D010138:Pacemaker, Artificial / Q000639:trends; D020521:Stroke / Q000175:diagnosis / Q000453:epidemiology* / Q000503:physiopathology; D017216:Telemedicine / Q000379:methods / Q000639:trends
keywords: Atrial fibrillation; Implantable cardioverter defibrillators; Pacemakers; Remote monitoring; Stroke; Telemedicine