Awareness of chronic disease technologies and remote monitoring among not only the medical community but the general population has continued to increase dramatically, as evidenced by the recent New York Times article about implantable defibrillators ability to remotely track heart failure patients. News coverage of these devices, which are poised to significantly improve quality of life for the 6 million people in the U.S. who suffer from HF, emphasizes the shift toward patient- and consumer-focused care and highlight's the public's increasing involvement in self-managing their health to a greater extent. In the Pipeline, we've covered numerous different developments in remote monitoring, which can all be found here.
For more information about remote monitoring, continue reading after the jump, or contact me at WynnP@advisory.com to discuss how Tech Insights is tracking these devices and their effect on EP and HF strategy.
New York Times Tracks Implantable CV Monitors
The ACC's Door to Balloon (D2B) initiative helped establish the concept "time is muscle," showing that early intervention for patients suffering a heart attack can significantly improve outcomes. Despite huge improvements in the hospital efficiencies in treating heart attack patients, however, individuals often wait too long to seek medical attention. A new implantable device presented this Wednesday at the 33rd annual scientific sessions for the Society for Cardiovascular Angiography and Interventions (SCAI) could help close the gap between symptom onset and medical attention by providing a clear alert to the patient that he or she is suffering a heart attack.
Angel Medical Systems' AngelMed Guardian is about the size of a pacemaker and is implanted into the chest and connected to a lead that is attached to the heart. The lead provides electrogram measurements that are constantly compared to a stored copy of the patient's normal electrogram. Any potentially dangerous shift in ST segment causes a series of alerts--the device itself buzzes inside the patient's chest, and an external hand-held telemetry device beeps and flashing LEDs.
New Implantable Device Provides Early Detection of MI, Plaque Rupture
The remote monitoring of EP devices has grown considerably in recent years. Today, hundreds of thousands of patients are implanted with cardiac rhythm management (CRM) devices that are capable of being monitored remotely (i.e., outside of a device clinic). The operational advantages of remote monitoring are obvious and easily demonstrated: a remote device-check takes less than half the time as an in-office check and eliminates 50 to 75 percent of clinic visits for routine check-ups. For these reasons, electrophysiologists have been quick to adopt the technology.
With the operational advantages well-understood, physicians are now trying to determine the clinical advantages of the technology. Today in Atlanta, Dr. George Crossley presented findings from the Clinical Evaluation Of Remote Notification to Reduce Time to Clinical Decision (CONNECT) trial. The trial used a wireless remote monitoring and notification system available through Medtronic's Conexus-enabled ICDs and CRT-Ds and compared its use to standard in-person clinic visits. The study showed that remote monitoring with automatic notification cut the time to clinical decision making by nearly two-thirds.
The largest randomized, prospective study designed to quantify the advantages of remote monitoring with automatic notifications, CONNECT followed nearly two thousand ICD and CRT-D patients at 136 sites in the United States. Data from the study showed a sizeable reduction in the time between the onset of an arrhythmic problem and a clinical decision on how to manage it (an average of 29.5 days in the standard-care group vs. 10.5 days in the remote-monitoring group). There was also a reduction in length of stay (LOS) for remote-monitored patients that had to be hospitalized, which Dr. Crossley estimated resulted in hospital savings of approximately one million dollars.
One interesting aspect of the remote-monitoring data was the gap in time between a notification and a clinical decision, which could be as long as 4 to 5 days. Dr. Crossley suggested this may show a 'Laissez-Faire' attitude among physicians to respond to data, but it may also reflect that the data does not carry an imperative for immediate action. We often hear complaints about data overload, a complaint that will only grow as more and more devices start transmitting an endless stream of bits and bytes. Could it be that the speed of data transmission may have out-paced its clinical need?