Abstract 10833: Does Prompted Monthly Review of Device Diagnostic Data Including Intrathoracic Impedance Trends Lead to More Prompt Clinical Action than Quarterly Review? Primary Results from the OptiVol Care Pathway Study
Background: Although remote monitoring of intrathoracic impedance trends has been available for the past few years, its clinical utility as part of heart failure disease management has been debated. The OptiVol® Care Pathway study tests the hypothesis that monthly proactive monitoring of such trends can lead to more prompt responses to clinically-relevant heart failure events.
Methods: We prospectively enrolled 1662 patients (51% ICDs, 86% primary prevention, 35% implanted <6 months) with OptiVol®-enabled implanted devices. These subjects were enrolled at 96 sites in the United States, and were randomized by site to remotely monitor their Cardiac Compass device diagnostics data including intrathoracic impedance trends either monthly review (MR, n=840) or quarterly review (QR, n=822) for a period of 12 months. Threshold crossing for OptiVol® fluid index was defined at 60 Ωdays (can be modified). Clinical action is defined as any intervention initiated based on the trend review based on available information and/or telephone contact following threshold crossing.
Results: 462 (56.9%) subjects in MR and 308 (39.7%) subjects in QR had received at least one clinical action by investigators. The time to the first clinical action was earlier in MR compared to that of QR (adjusted Hazard ratio 1.67, 95% confidence interval 1.24-2.24, p=0.0008). There were a total of 1,242 subjects that had at least one OptiVol® threshold crossing within the study period (639 in MR, 603 in QR), and the time to first clinical action prompted by an OptiVol® threshold crossing was also earlier in MR compared to that of QR (adjusted HR 1.50, 95% confidence interval 1.15-1.97, p=0.0036, Figure).
Conclusion: Threshold crossings were common and seen in the majority of the study cohort. Compared to quarterly review, monthly review of device diagnostics data including intrathoracic impedance trends is associated with more prompt clinical actions.
- © 2011 by American Heart Association, Inc.