AMSTERDAM – An implant-based remote monitoring system in patients with advanced heart failure significantly reduced the worsening of their condition, overnight hospitalization, and total mortality, according to a trial conducted by the device-maker.
The IN-TIME study, a multicenter, prospective, randomized, controlled trial, showed that the mortality at 1 year follow-up was 3.4% in the home monitoring group, compared with 8.7% in patients with standard care. This is the first time a home monitoring trial has shown a significant drop in death rate.
"IN-TIME is really a timely study," said Dr. Angelo Auricchio of Lugano, Switzerland, because the study coincides with the most recent ESC guidelines for CRT and pacemakers, which for the very first time contain recommendation for remote monitoring. Dr. Auricchio was one of the guideline’s authors.
Rehospitalization or death resulting from worsening heart failure are often preceded by clinical events or specific trends in clinical parameters. Use of home monitoring can detect some of these events and trends early, "offering the possibility to intervene and prevent hospitalization for worsening heart failure," said Dr. Gerhard Hindricks, the lead investigator of the trial, who presented the results at the annual congress of the European Society of Cardiology.
Findings from other trials, including TRUST and REFORM have hinted at the benefits of remote monitoring, but they didn’t show the significant results seen with IN-TIME.
Patients received Biotronik’s ICD or CRT-D equipped with home monitoring software. The device detects biological signals, such as heart rate, occurrence of arrhythmias, onset of arrhythmia or shocks, and transmits the signals to a small external patient communicator called Cardio Messenger, which in turn sends the signals to a centralized monitoring unit in Heart Center Leipzig, Germany.
"Trained nursing staff took the incoming data, and then activated a chain of action according to prespecified workflows,\" said Dr. Hindricks of University of Leipzig. In some cases, if the physician was not available, the providers would directly contact the patient to advise a follow-up with a general practitioner or appropriate clinic. The physician would also enter the information about the measure taken into the centralized monitoring system.
Researchers randomized 664 patients – 1:1, with no crossover – to either home monitoring (333) or standard of care (331). All patients were receiving optimal medical therapy.
The only significant difference in the use of ACE inhibitors between home monitoring and control groups (92% v. 86%, respectively), said Dr. Hindricks.
Patients were on average 65 years old and the majority was male. On average, 60% had an implanted CRT-D, and 40%, an ICD. Follow-up was 1 year.
The primary endpoint was the modified Packer Score, and 19% of the patients in the home monitoring group suffered from a worsening of their condition, compared with close to 28% in the group who were receiving the current standard of care only (P less than .05).
The secondary endpoint of all-cause mortality, also showed highly significant reduction in the home monitoring group (10 deaths), compared with the control arm (27 deaths) (P = .004). And, while 80% of all deaths were due to cardiovascular causes, there was a significant reduction in the cardiovascular mortality among the home monitoring group (8 deaths vs. 21 deaths in control; P = .012).
The home monitoring transmission rate was 85%, and there were 1,311 home monitoring observations, 66% of which were related to home monitoring issues; for instance, the patient’s device hadn’t transmitted data for 3 consecutive days, triggering an alert. The rest resulted from clinical events, with atrial fibrillation events being the most common (8.5%).
A total of 696 of patient contacts were made as a result of home monitoring alerts. Preliminary analysis of the data showed that 13% were from drug incompliance and 16% triggered additional visit to physician.
Dr. Hindricks said that one of the keys to the success of the program was minimal patient involvement.
Dr. Auricchio said that IN-TIME was a very important study "but we should have a cautionary note about the fact that the technology used is quite proprietary to one company, so the question is if it applies to other providers." He added that the study was done in a very defined patient population, and it’s yet to be seen whether its findings apply to other heart failure patients.
Dr. Hindricks has received honoraria for lectures and has been an adviser/consultant for Biosense, Biotronik, Stereotaxis, and St. Jude Medical. He has also been an adviser/consultant for CyberHeart. Dr. Auricchio has received payments from Biotronik, St. Jude Medical, Medtronic, Abbott, Philips, and several other companies.