Remote monitoring of heart failure patients via implants halves
29 August 2014
BIOTRONIK has announced that a clinical trial of its
implant-based remote monitoring system has lead to significant
clinical benefits for heart failure patients.
The results of the IN-TIME study show the system enables
physicians to detect worsening heart failure at an early stage,
facilitating early intervention and improved clinical outcomes.
Home Monitoring reduced all-cause mortality by over 50% and
clinical status was also significantly improved. Only 18.9% of
patients using Home Monitoring experienced the worsening of heart
failure, compared to 27.2% in the control arm (p=0.013). Patients
implanted with cardioverter defibrillators and cardiac
resynchronization therapy defibrillators (ICDs and CRT-Ds) benefited
equally from Home Monitoring. Patients with a known history of
atrial fibrillation especially benefited from Home Monitoring.
The BIOTRONIK-sponsored, prospective study randomized 664
patients with chronic heart failure, NYHA class II or III symptoms,
ejection fraction ≤35%, and optimal drug therapy in groups with or
without telemonitoring in a 1:1 ratio. Two hundred and seventy-four
patients received an ICD and 390 patients received a CRT-D in
adherence with European guidelines, and were followed for one year.
The primary outcome, worsening heart failure, was based on a
composite score including death, hospitalization, NYHA class and
patient self-assessment. Secondary outcomes included all-cause
mortality and hospitalization.
“Reducing mortality by over 50% is an excellent outcome for any
therapy. IN-TIME showed how important automatic, daily transmissions
of clinical and device data are to patient management and outcomes,”
explained coordinating investigator Dr. Gerhard Hindricks,
University of Leipzig Heart Center, Germany. “Improvements in
patients’ health are likely due to the early detection of the onset
or progression of ventricular and atrial tachyarrhythmias and the
early recognition of therapy settings that may need adjusting.”
Home Monitoring transmissions proved reliable, occurring on 85%
of days per patient year. Medical staff reacted quickly to events.
The median reaction time after remote monitoring alert was one day
to patient contact and two days to follow-up.
“The effects of Home Monitoring depend on physicians’ and medical
staff’s response to the remotely monitored data. By reacting quickly
to notifications, we were able to follow up with patients exactly
when they needed medical attention, and adapt their therapy
accordingly,” said Dr. Peter Sogaard, Aalborg University Hospital,
“We were also able to divide work between a qualified nurse and
myself, the overseeing physician, to improve our clinic’s workflow
and ensure efficient patient management.”
1 Hindricks G, et al. The Lancet. 2014, 384(9943).