Renato Pietro Ricci1, Diego Vaccari2, Loredana Morichelli3, Gabriele Zanotto4, Leonardo Calò5, Antonio D'Onofrio6, Antonio Curnis7, Ennio C L Pisanò8, René Nangah9, Marco Brieda10, Vittorio Calzolari11, Donato Melissano12, Nicola Rovai13, Alessio Gargaro13. 1. San Filippo Neri Hospital, Rome, Italy. Electronic address: renatopietroricci@tin.it. 2. Civil Hospital, Montebelluna, Italy. 3. San Filippo Neri Hospital, Rome, Italy. 4. Mater Salutis Hospital, Legnago, Italy. 5. Casilino Hospital, Rome, Italy. 6. V. Monaldi Hospital, Naples, Italy. 7. Spedali Civili, Brescia, Italy. 8. Vito Fazzi Hospital, Lecce, Italy. 9. Civil Hospital, Portogruaro, Italy. 10. Santa Maria degli Angeli Hospital, Pordenone, Italy. 11. Cà Foncello Hospital, Treviso, Italy. 12. F. Ferrari Hospital, Casarano, Italy. 13. Clinical Department, BIOTRONIK Italy, Vimodrone, Italy.
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.
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: David Duncker; Roman Michalski; Johanna Müller-Leisse; Christos Zormpas; Thorben König; Christian Veltmann Journal: Herzschrittmacherther Elektrophysiol Date: 2017-08-15
Authors: Jacopo Francesco Imberti; Alberto Tosetti; Davide Antonio Mei; Anna Maisano; Giuseppe Boriani Journal: Curr Cardiol Rep Date: 2021-05-07 Impact factor: 2.931