A randomized study of remote monitoring and fluid monitoring for the management of XXXX with implanted cardiac arrhythmia devices.

@entity1 @entity296 @entity712 @entity1165 @entity1457 @entity737
AIMS: Only limited comparative data exist on the benefits of fluid monitoring (FM) combined with remote monitoring (RM) regarding morbidity and mortality of @entity712 ( @entity712 ) @entity1 . This prospective single-centre randomized pilot study aimed to estimate the influence of RM in combination with FM on @entity712 hospitalizations as well as @entity1165 and mortality. METHODS AND RESULTS: @entity1 with standard indication for @entity737 ( @entity737 ) or cardiac resynchronization therapy and defibrillator were implanted with devices capable of RM and FM, and were followed for 15 months. Subjects were randomly allocated to RM including OptiVol and predefined management of alerts (remote group), or standard in-office visits every 3 months (control group). A total of 176 @entity1 (77% male; 66    12 years; left ventricular ejection fraction (LVEF) 32    11%; @entity296 50%; CRT device 50%; primary prevention 85%) were analysed. Cox proportional hazard analysis on the time to first @entity712 -related hospitalization showed a hazard ratio of 1.23 [0.62-2.44] (P = 0.551) favouring the control group. In the remote group, 13 @entity1 (15%) experienced @entity1457 vs. 10 @entity1 (11%) in the control group (P = 0.512). The average time to first @entity737 shock was 212    173 days in the remote arm and 212    143 days in the control arm (P = 0.994). The Kaplan-Meier estimate of mortality after 1 year was 8.6% (eight deaths) in the remote group vs. 4.6% in the control group (six deaths; P = 0.502). CONCLUSION: In a single-centre randomized pilot study of RM in combination with FM, no significant influence on @entity712 -related hospitalizations, @entity1457 , or mortality was found.
