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. 2016 Sep 15:219:251-6.
doi: 10.1016/j.ijcard.2016.06.016. Epub 2016 Jun 14.

Stroke incidence in patients with cardiac implantable electronic devices remotely controlled with automatic alerts of atrial fibrillation. A sub-analysis of the HomeGuide study

Renato Pietro Ricci  1 , Diego Vaccari  2 , Loredana Morichelli  3 , Gabriele Zanotto  4 , Leonardo Calò  5 , Antonio D'Onofrio  6 , Antonio Curnis  7 , Ennio C L Pisanò  8 , René Nangah  9 , Marco Brieda  10 , Vittorio Calzolari  11 , Donato Melissano  12 , Nicola Rovai  13 , Alessio Gargaro  13
Affiliations

Stroke incidence in patients with cardiac implantable electronic devices remotely controlled with automatic alerts of atrial fibrillation. A sub-analysis of the HomeGuide study

Renato Pietro Ricci et al. Int J Cardiol. .

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.

Keywords: Atrial fibrillation; Implantable cardioverter defibrillators; Pacemakers; Remote monitoring; Stroke; Telemedicine.

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