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Amsterdam, The Netherlands, Sunday 1 September 2013 – Heart failure patients have significant survival benefits when their implanted cardioverter-defibrillators (ICD) or cardiac resynchronization therapy defibrillators (CRT-D) are fitted with telemonitoring technology that alerts medical experts to potential problems, results of the IN-TIME trial reveal.
New technology that allows transmission of diagnostic data from implanted devices to a monitoring physician or clinic, as opposed to patients being followed via in-office visits, allows early detection of atrial or ventricular arrhythmias or specific trends in certain clinical parameters said lead investigator Gerhard Hindricks, MD, from the Heart Center Leipzig, Germany.
"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."
The IN-TIME trial showed that at one-year, significantly more patients randomized to telemonitoring scored better on a composite endpoint that included all-cause mortality and specific cardiac measures.
The prospective, randomized, controlled, multicenter trial analysed 664 patients, mean age 66±9 years, with chronic heart failure lasting for 3 months or more, class II or III New York Heart Association (NYHA) symptoms, and a reduced left ventricular ejection fraction (LVEF) of ≤35%.
Most patients included had ischemic heart disease (69%), mean LVEF was 26±6%, and heart failure medication diuretics (93%), beta-blockers (91%), and ACE inhibitors or angiotensin receptor blockers (89%).
The primary endpoint of IN-TIME was the modified Packer score, a clinical composite score consisting of mortality, overnight hospitalization for worsened heart failure, and NYHA class global self assessment.
A secondary endpoint of the trial was all-cause total mortality.
All patients were fitted with implanted devices that had a telemonitoring function, with 58% receiving a cardiac resynchronization device (CRT-D) and 42% an implantable dual chamber.
Data transmission was initiated by a time trigger (e.g. 3 AM every day) or by a relevant arrhythmic or technical event, and was transmitted from the patient's implanted device to a central monitoring unit at the Heart Centre Leipzig.
A run-in phase of one month was used to optimise patients' heart failure therapy and ensure that the device's transmission system was functioning after which patients were randomized to either telemonitoring (n=333) or standard care (n=331).
This meant that in the standard care group, telemonitoring data was still collected but was not accessible to the central monitoring unit or treating physicians until the end of the study. For these patients all treatment interventions were either patient-initiated or triggered by in-office follow-ups.
In contrast, for telemonitored patients, relevant observations such as frequency of ventricular extrasystoles, or atrial and ventricular tachyarrhythmia episodes were forwarded to the patient's treating physician, which could lead to additional follow-ups, and therapy changes at the physician's discretion.
At 12 months follow-up, significantly more patients in the control group as compared to the home monitoring group worsened according to the modified Packer score (27.5% vs 18.9%; p<0.05).
Moreover, there was a significantly lower rate of all-cause mortality as well as cardiovascular mortality in the telemonitoring arm compared to controls (3.4% vs 8.7%; P<0.01 ; p< 0.012 ).
"The next step is to carefully analyse triggers, events, medical actions and of course the time lines 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,"
"That will be the basis for the clinical application of the study results and of course for future research in the field."
DISCLOSURES: Dr. Hindricks declared he has received study grants, educational grants, and honoraria for lectures from Biotronik.