News | May 24, 2017

Home Monitoring Reduces All-Cause Mortality in ICD Patients

Newly Published TRUECOIN Meta-Analysis Shows Home Monitoring Saves Lives by Slowing Heart Failure Progression

Biotronik Home Monitoring implanted EP device remote wireless monitoring system

May 23, 2017 – Results now published in the European Heart Journal show Biotronik Home Monitoring reduces the risk of all-cause mortality in ICD patients after one year by 38 percent. The TRUECOIN study also found a 36 percent reduction in the combined risk of all-cause mortality and hospitalization for worsening heart failure.[1]

Cardiovascular disease is the number one cause of death globally.[2] Implantable cardioverter defibrillators (ICDs) control life-threatening arrhythmias, including those that cause sudden cardiac arrest. Some ICD patients also have heart failure, which affects 26 million people worldwide,[3] or two to three percent of the adult population.

The TRUECOIN study pooled 2,405 patients from the TRUST[4], ECOST[5] and IN-TIME[6] trials. The IN-TIME study showed more than a 50 percent risk reduction in all-cause mortality in ICD and CRT-D (cardiac resynchronization therapy defibrillator) patients with symptomatic heart failure. Based on these results, the European Society of Cardiology (ESC) recommends remote monitoring with the IN-TIME approach for this patient group in its latest heart failure guidelines.

The new meta-analysis extends the observed mortality benefit to a broader range of ICD patients with less severe heart failure. Furthermore, TRUECOIN identified the prevention of heart failure exacerbation as the underlying clinical mechanism of the observed benefits. Daily automatic transmission and analysis of a multiparameter data set make it possible to detect changes in heart failure status.

Other clinical studies like REM-HF, presented at ESC 2016, investigated remote monitoring systems and devices from other manufacturers, and have not found clinical benefits with remote monitoring. Dr. Gerhard Hindricks, lead investigator of TRUECOIN and IN-TIME, as well as president of the European Heart Rhythm Association, explained why TRUECOIN and IN-TIME show mortality benefits while other studies have not.

“It matters which technology you use,” said Hindricks, from the Leipzig Heart Center, Germany. “The IN-TIME and TRUECOIN results show that Biotronik Home Monitoring leads to improved clinical outcomes for patients. I believe this is due to differences in manufacturers’ technology, the data collected and clinic workflow.”

Concurrent with the publication of the TRUECOIN results, another study by Varma et al. investigating battery longevity and transmission reliability of Home Monitoring devices was published in Europace. The TRUST post-hoc analysis shows that Home Monitoring conserves battery longevity despite daily data transmissions. Results endorse the Heart Rhythm Society (HRS) Class 1A recommendation that remote monitoring be employed for battery conservation. The study also finds daily Home Monitoring transmissions to be highly reliable.[7]

Biotronik Home Monitoring can be programmed by a physician to transmit data automatically and on a daily basis, thereby rapidly detecting 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, in particular asymptomatic atrial fibrillation, enables the physician to adapt patient therapy at a very early stage.

For more information: www.biotronik.com

 

References:

1. Hindricks G et al. European Heart Journal. 2017, May 10. doi: https://doi.org/10.1093/eurheartj/ehx015
2. WHO Cardiovascular Diseases Fact Sheet, 2016.
3. CDC Heart Failure Fact Sheet, 2016.
4. Varma N et al. Europace. 2011, 13 (3).
5. Guedon-Moreau L et al. European Heart Journal. 2013, 34 (8).
6. Hindricks G et al. Lancet. 2014, 384 (9943).
7. Varma N et al. Europace. 2017, May 10. doi: https://doi.org/10.1093/europace/eux059

Related Content

A new infection risk scoring system has been developed based on data from the large PADIT Trial.[1] The new scoring system was presented as a follow up to that study during a late-breaking session at Heart Rhythm 2019, the Heart Rhythm Society's 40th Annual Scientific Sessions.

Figure 1: The PADIT infection risk score ranging from 0 to 14 points classified patients into three risk groups, low (0-4), intermediate (5-6) and high (≥7). The risk groups had rates of hospitalization for infection of 0.51%, 1.42% and 3.41%, respectively 

News | EP Lab | May 15, 2019
May 15, 2019 — A new infection risk scoring system has been developed based on data from the large PADIT Trial.[1] Th
Studies Find Race and Gender Disparities in Implantable Heart Devices
News | EP Lab | May 15, 2019
May 15, 2019 - Three new studies show that patients who are medically indicated for implantable heart devices, includ
Heart Rhythm 2019 study shows travelers with common cardiac devices can pass through without restrictions or precautions. HRS 2019, #HRS #HRS19

A new study shows travelers with common cardiac devices can pass through airport body scanners without restrictions or precautions.

News | EP Lab | May 14, 2019
May 14, 2019 – Results from new research show that passengers with cardiac implantable electronic devices (CIEDs), su
News | EP Lab | May 13, 2019
May 13, 2019 – Results from a new survey are the first to report a large discrepancy in patient’s knowledge of their
Concerto CRT-D and Virtuoso ICD implantable cardiac devices are among several Medtronic electrophysiology devices included in a safety alert because of their lack of cybersecurity measures to avoid hacking, according to the FDA.

Concerto CRT-D and Virtuoso ICD implantable cardiac devices are among several Medtronic electrophysiology devices included in a safety alert because of their lack of cybersecurity measures to avoid hacking, according to the FDA.

Feature | EP Lab | March 22, 2019
March 22, 2019 — The U.S.
Medtronic Tyrx Envelope Significantly Reduces Major Infections in Cardiac Implantable Device Patients
News | EP Lab | March 20, 2019
Results from the landmark Worldwide Randomized Antibiotic Envelope Infection Prevention Trial (WRAP-IT) demonstrated...
Videos | EP Lab | February 27, 2019
This is a virtual heart with the same electrophysiology characteristics as the real patient being developed to help o
Seth Worley, M.D., senior consultant, section of cardiac electrophysiology, MedStar Heart and Vascular Institute, developed tools and techniques to optimize transvenous left ventricular (LV) lead implantation, including the I-CRT approach. Here he holds the tools that he personally developed for left ventricular lead implantation to treat heart failure. Photo courtesy of MedStar Heart and Vascular Institute at MedStar Washington Hospital Center.

Seth Worley, M.D., senior consultant, section of cardiac electrophysiology, MedStar Heart and Vascular Institute, developed tools and techniques to optimize transvenous left ventricular (LV) lead implantation, including the I-CRT approach. Here he holds the tools that he personally developed for left ventricular lead implantation to treat heart failure. Photo courtesy of MedStar Heart and Vascular Institute at MedStar Washington Hospital Center.

Feature | EP Lab | January 21, 2019 | Matthew S. McKillop, M.D., FACC, FHRS, and Seth J. Worley, M.D.
Interventional...
An implanted ICD showing its three venous leads. These multiple CRT leads can cause issues when they need to be replaced and are abandoned with new leads put over them in the SVC, which may require lead extraction.

An implanted ICD showing its three leads in the venous system. 

Feature | EP Lab | January 13, 2019 | Dave Fornell, Editor
To extract or abandon broken or infected implantable, venous...
Overlay Init