RT Journal Article
T1 Safety and efficiency of a common and simplified protocol for pacemaker and defibrillator surveillance based on remote monitoring only: a long-term randomized trial (RM-ALONE).
A1 García-Fernández, Francisco Javier
A1 Osca Asensi, Joaquín
A1 Romero, Rafael
A1 Fernández Lozano, Ignacio
A1 Larrazabal, José María
A1 Martínez Ferrer, José
A1 Ortiz, Raquel
A1 Pombo, Marta
A1 Tornés, Francisco José
A1 Moradi Kolbolandi, Mehrard
K1 Implantable cardiac defibrillator
K1 Pacemaker
K1 Remote interrogation
K1 Remote monitoring
K1 Telemedicine
AB This trial aimed to evaluate the safety and efficiency of a common and simplified protocol for the surveillance of cardiac implantable electronic devices based on remote monitoring (RM) in patients with pacemakers (PMs) and implantable cardiac defibrillators (ICDs) for at least 24 months. The RM-ALONE is a multicentre prospective trial that randomly assigned 445 patients in two groups, both followed by RM: the home monitoring-only (HMo) based on RM + remote interrogations (RIs) every 6 months and the HM + IO that adds in-office evaluations every 6 months to RM. Four hundred and forty-five patients were enrolled in the study, 294 PMs and 151 ICDs recipients. In the HMo group, 20% of patients experienced ≥1 major adverse cardiac event (MACE) vs. 19.5% in HM + IO group (P = 0.006 for non-inferiority). The proportion of patients with a PM/ICD who experienced ≥1 MACE was 15.2/29.3% in HMo group and 16.1/26.3% in HM + IO group (hazard ratio 0.95/1.15, 95% confidence interval 0.53-1.70/0.62-2.10). There were 789 in-office evaluations (136 in the HMo and 653 in the HM + IO; P  The RM-ALONE protocol common for ICD and PM surveillance, consisting of RM + RI every 6 months has proven safe and efficient in reducing hospital visits and staff workload.
YR 2019
FD 2019
LK http://hdl.handle.net/10668/13607
UL http://hdl.handle.net/10668/13607
LA en
DS RISalud
RD Apr 9, 2025