HeartLogic is a multiparametric algorithm incorporated into implantable cardioverter-defibrillators (ICD). The associated alerts predict impending heart failure (HF) decompensations. Our objective ...was to analyze the association between alerts and clinical events and to describe the implementation of a protocol for remote management in a multicenter registry.
We evaluated study phase 1 (the investigators were blinded to the alert state) and phases 2 and 3 (after HeartLogic activation, managed as per local practice and with a standardized protocol, respectively).
We included 288 patients from 15 centers. In phase 1, the median observation period was 10 months and there were 73 alerts (0.72 alerts/patient-y), with 8 hospitalizations and 2 emergency room admissions for HF (0.10 events/patient-y). There were no HF hospitalizations outside the alert period. In the active phases, the median follow-up was 16 (95%CI, 15-22) months and there were 277 alerts (0.89 alerts/patient-y); 33 were associated with HF hospitalizations or HF death (n=6), 46 with minor decompensations, and 78 with other events. The unexplained alert rate was 0.39 alerts/patient-y. Outside the alert state, there was only 1 HF hospitalization and 1 minor HF decompensation. Most alerts (82% in phase 2 and 81% in phase 3; P=.861) were remotely managed. The median NT-proBNP value was higher within than outside the alert state (7378 vs 1210 pg/mL; P <.001).
The HeartLogic index was frequently associated with HF-related events and other clinically relevant situations, with a low rate of unexplained events. A standardized protocol allowed alerts to be safely and remotely detected and appropriate action to be taken on them.
HeartLogic es un algoritmo multiparamétrico incorporado a desfibriladores automáticos implantables (DAI). La alerta asociada predice descompensaciones de insuficiencia cardiaca (IC). Nuestro objetivo es analizar la asociación entre alertas y eventos clínicos bajo un protocolo de seguimiento común en un registro multicéntrico.
Se evaluaron la fase 1 (investigadores ciegos al estado de la alerta) y las fases 2 y 3 (tras la activación de HeartLogic, según práctica local y un protocolo común respectivamente).
Se incluyó a 288 pacientes en 15 centros. En fase 1, tras una media de observación de 10 meses, hubo 73 alertas (0,72 alertas/paciente-año), con 8 hospitalizaciones y 2 visitas a urgencias por IC (0,10 eventos/año-paciente). No hubo hospitalizaciones fuera del periodo de alerta. Las fases activas tuvieron una media de seguimiento de 16 (IC95%, 15-22) meses, con 277 alertas (0,89 alertas/año-paciente); 33 se asociaron con hospitalizaciones o muerte por IC, 46 con descompensaciones menores y 78 con otros eventos. La tasa de alertas inexplicables fue 0,39/año-paciente. Fuera del estado de alerta solo hubo una hospitalización y una descompensación menor. La mayoría de las alertas (el 82% en fase 2 y el 81% en fase 3; p=0,861) se gestionaron a distancia. La mediana de NT-proBNP fue superior en estado de alerta que fuera de él (7.378 frente a 1.210 pg/ml; p <0,001).
El índice HeartLogic se asoció con descompensaciones de IC y otros eventos relevantes, con baja tasa de alertas inexplicables. Un protocolo estandarizado permitió detectar y actuar a distancia con seguridad sobre las alertas.
The multiparametric implantable cardioverter-defibrillator HeartLogic index has proven to be a sensitive and timely predictor of impending heart failure (HF) decompensation. We evaluated the impact ...of a standardized follow-up protocol implemented by nursing staff and based on remote management of alerts.
The algorithm was activated in HF patients at 19 Spanish centers. Transmitted data were analyzed remotely, and patients were contacted by telephone if alerts were issued. Clinical actions were implemented remotely or through outpatient visits. The primary endpoint consisted of HF hospitalizations or death. Secondary endpoints were HF outpatient visits. We compared the 12-month periods before and after the adoption of the protocol.
We analyzed 392 patients (aged 69±10 years, 76% male, 50% ischemic cardiomyopathy) with implantable cardioverter-defibrillators (20%) or cardiac resynchronization therapy defibrillators (80%). The primary endpoint occurred 151 times in 86 (22%) patients during the 12 months before the adoption of the protocol, and 69 times in 45 (11%) patients (P<.001) during the 12 months after its adoption. The mean number of hospitalizations per patient was 0.39±0.89 pre- and 0.18±0.57 postadoption (P<.001). There were 185 outpatient visits for HF in 96 (24%) patients before adoption and 64 in 48 (12%) patients after adoption (P<.001). The mean number of visits per patient was 0.47±1.11 pre- and 0.16±0.51 postadoption (P<.001).
A standardized follow-up protocol based on remote management of HeartLogic alerts enabled effective remote management of HF patients. After its adoption, we observed a significant reduction in HF hospitalizations and outpatient visits.
