Pooled Analysis of Three Clinical Trials Finds 38 Percent Reduced Risk of All-Cause Mortality in ICD Patients Using BIOTRONIK Home Monitoring, by Slowing Heart Failure’s Progression
BERLIN, Germany and ROME, Italy, August 30, 2016 — During a scientific talk at the 2016 European Society of Cardiology (ESC) Congress, Dr. Gerhard Hindricks, Leipzig Heart Center, Germany, presented results of a meta-study showing that BIOTRONIK Home Monitoring® is associated with a 38 percent reduced risk for all-cause mortality after one year in all ICD patients. These results were observed in comparison with conventional office follow-up alone and also found a 36 percent reduction in the combined risk of all-cause mortality or hospitalization for worsening heart failure.
The TRUECOIN study pools 2,405 patients from the TRUST1, ECOST2 and IN-TIME3 trials. The IN-TIME study alone had already shown a more than 50 percent risk reduction for all-cause mortality in heart failure patients specifically. The meta-analysis now extends the mortality benefit to the full range of ICD patients. "It must be pointed out that the clinical benefits have only been demonstrated for BIOTRONIK Home Monitoring. Other studies examining remote monitoring systems could not show this effect," said lead investigator Dr. Hindricks.
Features Unique to BIOTRONIK Home Monitoring Make the Difference
The pooled study also suggests a link between using BIOTRONIK Home Monitoring specifically and the demonstrated clinical benefits. "The results suggest BIOTRONIK Home Monitoring is effective in helping to reduce mortality in patients with a wide variety of ICD indications, and to slow the progression of heart failure," commented Dr. Hindricks. "We observed these benefits by analysing studies that only used Home Monitoring, rather than combining data from patients followed using systems that have differing operational features. Hence, analyzing individual remote monitoring systems may be preferable to global analyses."
BIOTRONIK Home Monitoring is the only remote monitoring system on the market that uses daily transmission verification. "The meta-analysis clearly shows that it does matter which remote monitoring system is used. The daily transmissions, along with multi-parameter analysis and an established clinical workflow, provide physicians with the most robust set of information possible," stated Manuel Ortega, Senior Vice President, BIOTRONIK. "That wealth of information helps enable intervention earlier, making an appreciable difference in patient care, which this data now confirms."
1 Varma N, et al. Eur Heart J. 2014, 35 (20).
2 Guedon-Moreau L, et al. Europace. 2014, 16(8).
3 Hindricks G, et al. Lancet. 2014, 384 (9943).
About BIOTRONIK Home Monitoring
BIOTRONIK Home Monitoring can be programmed by a physician to transmit data automatically and on a daily basis, thereby rapidly detecting any deterioration in a patient’s clinical status. The occurrence of atrial or ventricular arrhythmias or specific trends in certain clinical parameters can often be the first sign of worsening heart failure leading to hospitalization or death. Early detection of these clinically relevant events enables the physician to adapt patient therapy at a very early stage.
A global leader in cardio- and endovascular medical technology, BIOTRONIK is headquartered in Berlin, Germany, and represented in over 100 countries. Several million patients have received BIOTRONIK implants designed to save and improve the quality of their lives, or have been treated with BIOTRONIK coronary and peripheral vascular intervention products. Since its development of the first German pacemaker in 1963, BIOTRONIK has engineered many innovations, including Magmaris, the first clinically-proven resorbable magnesium scaffold; BIOTRONIK Home Monitoring; Pulsar, the world’s first 4 F compatible stent for treating long lesions; Orsiro, the industry’s first hybrid drug-eluting stent; and the world’s first implantable cardioverter defibrillators and heart failure therapy devices with ProMRI® technology.