Faster Connections: Remote Monitoring Reduces Event-to-Decision Time

Reed Miller

March 15, 2010

March 15, 2010 (Atlanta, Georgia) — Connection to a remote monitoring network reduces the delay between clinical events and clinical decisions and may shorten patients' stay in the hospital, results of the Clinical Evaluation of Remote Notification to Reduce Time to Clinical Decision (CONNECT) trial show.

Dr George Crossley (University of Tennessee College of Medicine, Nashville) presented results of the 1997-patient CONNECT trial during today's late-breaking clinical-trials sessions here at the American College of Cardiology 2010 Scientific Sessions.

"This is the first trial to show that remote follow-up actually creates outcome measures that we can put our arms around and shows we can improve care," he said during a press conference after presenting the data.

The study measured the time from an adverse event--including arrhythmias and device malfunctions--until a clinician made a decision about the problem in 1997 patients at 136 sites. The patients were implanted with Medtronic implantable cardioverter defibrillators (ICDs) equipped with the Conexus telemetry system that can send regular reports and immediate alerts of potential problems to the patient's doctor through Medtronic's CareLink network.

The 1014 patients in the remote-monitoring group visited their doctor one month after their device was implanted and again after 15 months, but in between, they were followed by their doctor only through CareLink. The 983 patients in the control group were not connected to CareLink and had regular doctor's office visits about every three months for 15 months.

The median time from an adverse event to a doctor's decision on how to handle it was significantly shorter in the remote-monitoring group. The average event-to-decision time was 29.5 days in the standard-care group and 10.5 days in the remote-monitoring group. The median time from event to decision was 4.6 days in the remote-monitoring arm and 22 days in the in-office arm (p<0.0001).

The event-to-decision times were shorter for most types of clinical events tracked, although the median time to decision following two ICD shocks in the same episode was zero days in both groups, as was the median time to decision when the ICD's ventricular-fibrillation detection or therapy shut off.

Number of Adverse Events and Time From Event to Clinical Decision

Device event Events (patients), remote group Events (patients), in-office group Median days between event and clinical decision, remote group Median days between event and clinical decision, in-office group
AT/AF burden >12 h 437 (107) 280 (105) 3 24
Ventricle rate >120 bpm during >6 h of AT/AF 41 (26) 47 (37) 4 23
Lead impedances out of range 26 (18) 12 (6) 0 17

Median time to decision following two shocks in the same episode was zero days in both groups; Median time to decision following VF-detection/therapy shutoff was zero in both groups, AT=atrial tachyarrhythmia; AF=atrial fibrillation; VF=ventricular fibrillation

Patients in the remote-monitoring arm had slightly more unscheduled visits to their doctor, 2.24 vs 1.94, but because they had only two scheduled visits, patients in the remote-monitoring group had fewer than four office visits total, on average, during the 15-month follow-up, while the in-office group patients saw their doctor more than six times, on average.

The remotely monitored patients were slightly more likely to visit the hospital, but this difference was statistically insignificant. Remotely monitored patients who were hospitalized had a shorter average length of hospital stay, 3.3 days vs four days, a statistically significant 18% reduction saving of about $1659 per hospitalization per patient and over a million dollars for the entire study.

Crossley said that the reduction in hospitalization was most likely due to the ability of remote monitoring to catch atrial fibrillation, especially people with atrial fibrillation with rapid ventricular response, earlier in the progression of the disease. "The magnitude of the saving over the course of the study was not huge, but for those patients who were hospitalized, it was significant." Previous studies have shown that remote monitoring saves money by reducing doctor's office visits.

Crossley said that the delay to hospitalization for new-onset atrial fibrillation, even in the remote-monitoring group, was his "big disappointment in the study."

Commenting on the delays to decision for atrial-fibrillation patients, Dr John Miller (Indiana University School of Medicine, Indianapolis) pointed out that some of the other device alerts triggered much more rapid responses and suggested that the often-slow response to the onset of atrial fibrillation "is our problem in taking a more laissez-faire attitude to those patients." Crossley said, "That four-day period from the onset of afib to deciding what to do about afib is a problem and gives us a real opportunity for using best practices to move that to where it ought to be."

The CONNECT trial is sponsored by Medtronic. Crossley disclosed that he has significant research and consulting arrangements with Medtronic and a research agreement with St Jude and that he is a speaker for Medtronic and Boston Scientific.

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