Cardiac Resynchronization Therapy
Cardiac Resynchronization Therapy
Remote monitoring (RM) has been widely embraced in the USA and Europe. In the USA, there are now over 800 000 patients actively monitored by the RM network. There are many potential benefits of remote patient monitoring beyond the obvious convenience and security of being able to download detailed stored information of an event. Although RM is not limited to CRT, the subject of this review, the growing body of literature regarding RM for all implantable cardiac devices is germane given overlap of devices and overlap of data collected that currently is or could be remotely transmitted.
When RM was introduced, and to some extent this persists, there was concern that patients and caregivers would not be satisfied with RM because they would lose the advantage of a face-to-face visit. Multiple studies have shown that both patients and caregivers are satisfied with RM both in terms of its ease of use and remaining connected to the follow-up center. In some situations, specifically following an advisory or recall, patients have expressed a preference for RM in terms of psychological well-being, feeling as though there is a better chance of diagnosing a problem should it occur.
Advantages of RM for pacemakers, ICDs, and CRT devices have been demonstrated in randomized clinical trials. In the CONNECT trial, resource utilization was shown to be lower with RM with the observed rate of total clinic visits per patient year was 3.92 in the RM group as opposed to 6.27 for the group monitored in-office. Remote monitoring also has the potential to detect clinical abnormalities that would potentially be detected later or missed by less frequent in-office visits in the absence of regular RM data assessment. In the TRUST trial (n = 1333), RM detected ICD system related problems earlier, detected by RM at a median of 1 day vs. 5 days for the control (non-RM) group. Overall, the study detected 20 device-related problems that required surgical revision and 15 of these were detected by RM and only 5 in their control group. In the PREFER trial which assessed pacemakers only, the mean time to the diagnosis of the first clinical event that required clinical action occurred at 5.7 months in the RM arm of the study and at 7.7 months in the control group. Perhaps as a result of earlier detection of clinical problems, resulting hospitalizations may be shorter in patients enrolled in a RM system. In the CONNECT trial which evaluated 1997 patients with ICDs and CRT-D devices, the RM arm of the trial had significantly shorter hospitalization length of stays than those patient's followed in the clinic (P = 0.002). There is trial data to support more rapid clinical decision making as a result of RM. In the CONNECT trial, the time from a clinically significant event to making a clinical decision in the RM arm was significantly shorter than in the 'in-office' arm (P< 0.001), and the median time in the RM arm was 4.6 days vs. 22 days in the in-office arm.
Analyses of large numbers of patients enrolled in RM are providing useful data from large-scale registries offering an insight into real-world outcomes. For example, data from LATITUDE and CARELINK RM networks have demonstrated long-term survival benefits of RM as well as insights into clinical management of patients with implanted cardiac devices. A recent study of 377 patients with CRT-D devices capable of daily transmission of their diagnostic data evaluated an automated algorithm for dynamically predicting cardiovascular events. This algorithm and potentially others that incorporate additional physiological parameters data for which transmitted RM data are sparse have the potential to improve quality of life and reduce morbidity and mortality.
Remote Monitoring and Device-based Disease Management
Remote monitoring (RM) has been widely embraced in the USA and Europe. In the USA, there are now over 800 000 patients actively monitored by the RM network. There are many potential benefits of remote patient monitoring beyond the obvious convenience and security of being able to download detailed stored information of an event. Although RM is not limited to CRT, the subject of this review, the growing body of literature regarding RM for all implantable cardiac devices is germane given overlap of devices and overlap of data collected that currently is or could be remotely transmitted.
When RM was introduced, and to some extent this persists, there was concern that patients and caregivers would not be satisfied with RM because they would lose the advantage of a face-to-face visit. Multiple studies have shown that both patients and caregivers are satisfied with RM both in terms of its ease of use and remaining connected to the follow-up center. In some situations, specifically following an advisory or recall, patients have expressed a preference for RM in terms of psychological well-being, feeling as though there is a better chance of diagnosing a problem should it occur.
Advantages of RM for pacemakers, ICDs, and CRT devices have been demonstrated in randomized clinical trials. In the CONNECT trial, resource utilization was shown to be lower with RM with the observed rate of total clinic visits per patient year was 3.92 in the RM group as opposed to 6.27 for the group monitored in-office. Remote monitoring also has the potential to detect clinical abnormalities that would potentially be detected later or missed by less frequent in-office visits in the absence of regular RM data assessment. In the TRUST trial (n = 1333), RM detected ICD system related problems earlier, detected by RM at a median of 1 day vs. 5 days for the control (non-RM) group. Overall, the study detected 20 device-related problems that required surgical revision and 15 of these were detected by RM and only 5 in their control group. In the PREFER trial which assessed pacemakers only, the mean time to the diagnosis of the first clinical event that required clinical action occurred at 5.7 months in the RM arm of the study and at 7.7 months in the control group. Perhaps as a result of earlier detection of clinical problems, resulting hospitalizations may be shorter in patients enrolled in a RM system. In the CONNECT trial which evaluated 1997 patients with ICDs and CRT-D devices, the RM arm of the trial had significantly shorter hospitalization length of stays than those patient's followed in the clinic (P = 0.002). There is trial data to support more rapid clinical decision making as a result of RM. In the CONNECT trial, the time from a clinically significant event to making a clinical decision in the RM arm was significantly shorter than in the 'in-office' arm (P< 0.001), and the median time in the RM arm was 4.6 days vs. 22 days in the in-office arm.
Analyses of large numbers of patients enrolled in RM are providing useful data from large-scale registries offering an insight into real-world outcomes. For example, data from LATITUDE and CARELINK RM networks have demonstrated long-term survival benefits of RM as well as insights into clinical management of patients with implanted cardiac devices. A recent study of 377 patients with CRT-D devices capable of daily transmission of their diagnostic data evaluated an automated algorithm for dynamically predicting cardiovascular events. This algorithm and potentially others that incorporate additional physiological parameters data for which transmitted RM data are sparse have the potential to improve quality of life and reduce morbidity and mortality.
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