TRUST trial: Follow-up surveillance
of implantable defibrillators is improved by home monitoring compared to hospital
visits
Patients receiving implantable cardioverter defibrillators
(ICDs) can be monitored safely through remote monitoring with only one annual
follow-up visit according to results form the TRUST (Lumos-T Safely Reduces Routine
Office Device Follow Up) trial presented at the 2009 ESC Congress.
The number of patients receiving life saving implantable
cardioverter defibrillators (ICDs) is increasing and affects millions worldwide.
These devices collect important system and patient data and monitoring their function
is very important but is practiced inconsistently. Routine conventional follow-up
visits every 3 to 6 months are recommended but, for some patients, this is sometimes
difficult to adhere to. The problem with conventional follow-up visits is that
no surveillance occurs in between visits. A means of intensive device monitoring
without overburdening device clinics is desirable and this role is fulfilled by
Home Monitoring.
Automatic transmission, independent of patient or physician
interaction, has the ability to maintain surveillance and rapidly bring to attention
significant data, enabling clinically appropriate intervention. This form of technology
was tested in the TRUST (Lumos-T Safely Reduces Routine Office Device Follow Up)
trial. TRUST is the first and largest study (enrolling 1,443 patients) prospectively
assessing follow up both conventionally and with remote monitoring.
This current report shows that patients could be monitored
safely with only one annual scheduled hospital visit and three monthly checks
performed via remote monitoring. Remote monitoring cut out unnecessary hospital
visits by almost a half. The use of remote monitoring secured greater follow-up
adherence to the three monthly calendar based checks. The TRUST trial showed patient
data may be monitored remotely anytime and from anywhere, as opposed to in the
conventional care which relies on patients to present themselves physically in
their physician's office. However, calendar based checks overall, whether conventionally
or remotely, picked up few important events. These were more likely to occur in
between scheduled checks, and when they occurred were detected much faster by
remote monitoring (median <3 days) of cardiac and/or device problems compared
to >30 days with conventional care.
The TRUST trial proves that remote monitoring provides
physicians with an important tool for managing patients with implantable device
therapy efficiently. It performs daily surveillance, helps to maintain continuity
of follow up, and identifies the exceptional group of patients requiring in-clinic
attention. Patient convenience is improved since unnecessary follow-up visits
are avoided and necessary in-office evaluation is facilitated.
Niraj Varma, M.D., TRUST principal investigator, stated
at the ESC Congress that: "The data demonstrates yet another benefit that Home
Monitoring brings to patients, as well as physicians." Dr. Varma continued, "Based
on the results TRUST, a large-scale clinical trial, I believe that remote monitoring
may improve physician's ability to care for patients with implanted cardiac devices
and enhance patient safety."
The technology tested was Biotronik Home Monitoring,
an automatic, wireless system that performs daily telemetric surveillance of the
patient and the technical status of the implanted device, without requiring patient
activation.
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