Adolfo Fontenla1, Jose B Martínez-Ferrer2, Javier Alzueta3, Xavier Viñolas4, Arcadi García-Alberola5, Josep Brugada6, Rafael Peinado7, Maria J Sancho-Tello8, Alicia Cano9, Ignacio Fernández-Lozano10. 1. University Hospital 12 de Octubre, Av de Córodoba sn, 28041, Madrid, Spain drfontenla@gmail.com. 2. University Hospital of Araba, Calle Jose itxotegi sn, 01009, Vitoria-Gasteiz, Alava, Spain. 3. University Hospital Virgen de las Victoria, Campus de Teatinos sn, 29010 Malaga, Spain. 4. Hospital de la Santa Creu i Sant Pau, Carrer de Sant Quinti, 89, 08026 Barcelona, Spain. 5. University Hospital Virgen de la Arrixaca, Ronda de Levante, 11, 30008 Murcia, Spain. 6. Hospital Clìnic i Provincial, Carrer Villarroel, 170, 08036 Barcelona, Spain. 7. University Hospital La Paz, Paseo de la Castellana 261, 28046 Madrid, Spain. 8. University Hospital La Fe, Avenida Campanar, 21, 46026 Valencia, Spain. 9. Cardiac and Vascular Group, Medtronic Iberica, Calle Maria de Portugal, 9, 28050 Madrid, Spain. 10. University Hospital Puerta de Hierro-Majadahonda, Calle Manuel de Falla, 1, 28222, Majadahonda, Madrid, Spain.
Abstract
AIMS: The benefit of implantable cardioverter-defibrillators (ICDs) in patients at risk of sudden death has been established in randomized clinical trials (RCTs) using the ICD models available at the time. However, observational large-scale data on the incidence of arrhythmias in up-to-date ICDs implanted according to the current guidelines are scarce. The aim was to assess the incidence of arrhythmias in a large, current ICD population based on a blinded peer review of the detected episodes. METHODS AND RESULTS: UMBRELLA is a multicentre, observational registry of ICD patients followed by remote monitoring. Stored episodes were classified by a blinded committee of experts. Subgroup analyses were based on clinical profiles established by previous pivotal RCTs of ICDs. Of 1514 enrolled patients, 605 (39.9%) patients had 5951 episodes after 26 ± 17 months follow-up, being 3353 of them (56.3%) sustained ventricular arrhythmias (SVA), and 13.2% of SVA were self-terminated. Appropriate and inappropriate shocks occurred in 11.6 and 5% of patients, respectively. The 3 years cumulative incidence of SVA was 25% (95% CI: 21-28%) in primary prevention patients and 41% (95% CI: 36-47%) in secondary prevention patients (P < 0.001). Male gender, secondary prevention, and atrial fibrillation as basal rhythm were significantly related to a higher incidence of SVA. CONCLUSION: This real-world analysis suggests that modern ICD patients have a low rate of appropriate and inappropriate shocks. The risk of SVA in secondary prevention patients is less than what has been reported in RCTs. Published on behalf of the European Society of Cardiology. All rights reserved.
AIMS: The benefit of implantable cardioverter-defibrillators (ICDs) in patients at risk of sudden death has been established in randomized clinical trials (RCTs) using the ICD models available at the time. However, observational large-scale data on the incidence of arrhythmias in up-to-date ICDs implanted according to the current guidelines are scarce. The aim was to assess the incidence of arrhythmias in a large, current ICD population based on a blinded peer review of the detected episodes. METHODS AND RESULTS: UMBRELLA is a multicentre, observational registry of ICDpatients followed by remote monitoring. Stored episodes were classified by a blinded committee of experts. Subgroup analyses were based on clinical profiles established by previous pivotal RCTs of ICDs. Of 1514 enrolled patients, 605 (39.9%) patients had 5951 episodes after 26 ± 17 months follow-up, being 3353 of them (56.3%) sustained ventricular arrhythmias (SVA), and 13.2% of SVA were self-terminated. Appropriate and inappropriate shocks occurred in 11.6 and 5% of patients, respectively. The 3 years cumulative incidence of SVA was 25% (95% CI: 21-28%) in primary prevention patients and 41% (95% CI: 36-47%) in secondary prevention patients (P < 0.001). Male gender, secondary prevention, and atrial fibrillation as basal rhythm were significantly related to a higher incidence of SVA. CONCLUSION: This real-world analysis suggests that modern ICDpatients have a low rate of appropriate and inappropriate shocks. The risk of SVA in secondary prevention patients is less than what has been reported in RCTs. Published on behalf of the European Society of Cardiology. All rights reserved.
Authors: Finn Akerström; Marta Pachón; José B Martínez-Ferrer; Javier Alzueta; Luisa Pérez; Ignacio Fernández Lozano; Anibal Rodríguez; Miguel A Arias Journal: Indian Pacing Electrophysiol J Date: 2020-03-09
Authors: Sem Briongos-Figuero; Arcadio García-Alberola; Jerónimo Rubio; José María Segura; Aníbal Rodríguez; Rafael Peinado; Javier Alzueta; José B Martínez-Ferrer; Xavier Viñolas; Joaquín Fernández de la Concha; Ignasi Anguera; María Martín; Laia Cerdá; Luisa Pérez Journal: J Am Heart Assoc Date: 2020-12-25 Impact factor: 5.501