Wireless Way to Reduce Time to Clinical Decision

15th March 2010

Medtronic has announced results from the CONNECT trial showing the median time to clinical decision was significantly reduced for cardiac resynchronization therapy-defibrillator (CRT-D) and implantable cardioverter-defibrillator (ICD) patients monitored remotely with the Medtronic CareLink Network, compared to standard in-office follow-up. The trial showed the time from a patient's clinical event (arrhythmias, cardiovascular disease progression, and device issues) to the physician's clinical decision was 22 days for those monitored in-office, versus 4.6 days for patients in the remote monitoring group (p<0.001).

The CONNECT (Clinical Evaluation of Remote Notification to Reduce Time to Clinical Decision) data also showed a statistically significant decrease in mean length of cardiovascular hospital stays from four days in the in-office arm to 3.3 days in the remote monitoring arm (p=0.002). Due to the shorter length of stay, cardiovascular hospitalization costs were reduced by an estimated $1,659 per hospitalization. Furthermore, the data showed replacement of routine in-clinic visits with remote monitoring did not significantly increase other health care utilization, such as emergency room visits, cardiovascular hospitalizations, and unscheduled clinic visits.

"The CONNECT data showed remote monitoring with the CareLink Network not only significantly reduced the time to clinical decision, but also may reduce the need for standard in-clinic visits, which may not always be necessary for the patient, and often place added burden on the physician's clinic," said George H. Crossley, M.D., F.A.C.C., Saint Thomas Research Institute and Saint Thomas Heart at Baptist Hospital in Nashville. "At the same time, these data lead us to believe there may be other potential benefits of remote monitoring, including a reduction in mean length of stay for cardiovascular hospitalizations, which may have an economic impact on the patient and the healthcare system."

The prospective CONNECT trial randomized 1,997 patients implanted with an ICD with or without CRT capabilities, from 136 sites in the United States to remote monitoring versus standard in-office care. The study evaluated the time from clinical event to clinical decision in response to the event, as well as the associated impact on health care utilization, such as hospitalizations and visits to the emergency department. All patients were followed for 15 months post-implant.

The 1,104 patients monitored remotely were given Medtronic's wireless remote management system, consisting of the Medtronic CareLink Network and Monitor, Concerto CRT-D and Virtuoso ICD with Conexus Wireless Telemetry, and CareAlert Monitoring, for transmitting device information to the physician's office. These devices used wireless telemetry, allowing the automatic transmission of diagnostics to the physician without the need for patient intervention. The 983 patients receiving in-office care were followed at a fixed standard-of-care schedule, without remote monitoring.