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IN-TIME: Better outcomes, less mortality with home HF monitoring
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AMSTERDAM — Wireless monitoring of implanted devices was associated with a significant reduction in all-cause mortality, according to new data from the IN-TIME study.
The prospective, randomized, controlled, multicenter trial focused on patients with chronic HF lasting for 3 months or longer, class II or III NYHA symptoms and a reduced left ventricular ejection fraction ≤35%.
Gerhard Hindricks, MD, from the Heart Center Leipzig, Germany, presented data on the use of new technology that allows transmission of diagnostic data from implanted devices to a monitoring physician or clinic, as opposed to patient follow-up during in-office visits.
“The rapid transmission of information compared to traditional methods of monitoring patients gives physicians more time to intervene if necessary, thereby preventing serious or even fatal events,” Hindricks stated in a press release.
All patients had implanted devices with a telemonitoring function; 58% had a cardiac resynchronization device (CRT-D) and 42% had an implantable cardioverter defibrillator. Data transmission was initiated by a time trigger or by a relevant arrhythmic or technical event, and data were sent from the device to a central monitoring unit at the Heart Center Leipzig, which could result in further follow-up and therapy changes.
For the purpose of this study, patients were randomly assigned telemonitoring (n=333) or standard care (n=331). In the standard care group, telemonitoring data were collected, but were not accessible to the central monitoring unit or treating physicians until the end of the study; all treatment interventions were patient initiated or triggered by in-office follow-up, according to a press release.
The primary endpoint was modified Packer score, a clinical composite consisting of mortality, overnight hospitalization for worsened HF and NYHA class global self assessment. At 1 year, Packer score was significant different between the two groups, in favor of the telemonitoring group (18.9% vs. 27.5%; P<.05), Hindricks reported at a press conference.
In addition, telemonitoring was associated with significantly lower rates of all-cause mortality (10 vs. 27 deaths; HR=0.356; 95% CI, 0.172-0.735) and CV mortality (8 vs. 21 deaths; HR=0.367; 95% CI, 0.162-0.828).
“As evident from this trial, patients who are supported with an advanced telemedical application who have advanced HF despite optimal medical therapy had significant benefit from home monitoring. This is evident by the reduction in worsening of HF, overnight hospitalization and, most importantly, total mortality,” Hindricks said.
Most patients included in the IN-TIME study had ischemic heart disease (69%), mean LVEF was 26%, and the majority were taking diuretics (93%), beta-blockers (91%), and ACE inhibitors or angiotensin receptor blockers (89%). The mean age of the patients was 66 years.
“The next step is to carefully analyze triggers, events, medical actions and of course the timelines to better understand the mechanism(s) by which modified Packer score was improved and all-cause mortality was so strongly reduced in heart failure patients supported by home monitoring,” Hindricks stated in the release.
Biotronik made all of the devices studied. – by Katie Kalvaitis
For more information:
Hindricks G. Hot Line II: Late breaking trials on intervention and devices. Presented at: the European Society of Cardiology Congress; Aug. 31-Sept. 4, 2013; Amsterdam.
Disclosure: Hindricks reports receiving study grants, educational grants and honoraria for lectures from Biotronik.