Tratamiento a distancia de la insuficiencia cardiaca mediante el algoritmo HeartLogic. Registro RE-HEART / Remote heart failure management using the HeartLogic algorithm. RE-HEART registry

Introducción y objetivos 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. Métodos 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). Resultados 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). Conclusiones 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 (AU)

Introduction and objectives 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. Methods 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). Results 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). Conclusions 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 (AU)

Enoxaparin as bridging anticoagulant treatment in cardiac surgery.

OBJECTIVE: To assess enoxaparin as bridging anticoagulant treatment in cardiac surgery. METHODS: Prospective registry of those patients who underwent cardiac surgery in our centre between December 2003 and June 2004 and required long-term anticoagulation. Subcutaneous enoxaparin was used as bridging anticoagulant treatment according to a pre-established protocol. The global thromboembolic risk was carefully assessed in all patients. All patients were followed up for 3 months. RESULTS: Of 140 patients who were included (mean (SD) age 66 (11); 49% female), 51 were already receiving long-term acenocumarol treatment before the index intervention. 50% of the patients were at high or very high risk for thromboembolic events in the postoperative period. The mean (SD) number of days between surgery and the first dose of anticoagulant was 2.01 (7) for acenocumarol and 1 (1.01) for enoxaparin. The mean (SD) daily dose of enoxaparin was 1.1 (0.27) mg/kg. Six thromboembolic events (4.3%; 95% CI 1.6 to 9.1) occurred, but only four of them were plausibly related to enoxaparin (2.9%; 95% CI 0.8 to 7.1). Six major haemorrhagic events (4.3%; 95% CI 1.6 to 9.1) occurred, but only three were plausibly related to enoxaparin (2.1%; 95% CI 0.4 to 6.1). CONCLUSIONS: These findings show a reasonable rate of adverse events using enoxaparin as bridging anticoagulant treatment in cardiac surgery. Randomised studies are necessary to evaluate the real efficacy and safety of enoxaparin as bridging anticoagulant treatment in cardiac surgery.