BERLIN–(BUSINESS
WIRE)–BIOTRONIK announced today the publication of “Detection of atrial high-rate events by continuous Home
Monitoring: clinical significance in the heart failure-cardiac
resynchronization therapy population” in Europace by Dr. Nesan Shanmugam et
al.1 This analysis of data, pooled from two randomized, prospective,
international, multicenter studies, showed that short-duration atrial high-rate
events (AHRE) were significantly associated with a higher risk for thromboembolic events such as stroke. BIOTRONIK Home Monitoring®, with its capability of
continuous monitoring-and FDA- and CE-approved early detection of clinically
relevant events, including asymptomatic atrial arrhythmias-can support
physicians with identifying these patients who are at a higher risk.
“We conducted this analysis because uncertainty has existed
over the importance of device-detected, short-duration atrial arrhythmias,”
commented Professor Stefan Sack, Chair and Director, Department of
Cardiology, Pneumonology and Intensive Care Medicine, Academic General Hospital
Munich-Hospital Schwabing, Germany, and senior author of the publication.
“Continuous atrial diagnostics conducted by the BIOTRONIK Home Monitoring®
technology give us an opportunity to assess the frequency and duration of atrial fibrillation (AF) episodes defined as AHRE.”
Data were analyzed from 560 heart failure (HF) patients with implanted cardiac
resynchronization therapy (CRT) devices who were enrolled in two separate
studies. Patients were divided into four groups based on whether or not they
had a prior history of AF at study enrolment and whether or not they developed
AHRE during the study follow-up period. To determine what duration of AHRE is
associated with increased risk, the patients were later divided into three
subsets based on the amount of AHRE (zero, low [below median] or high [above median]).
AHRE burden was defined as the duration of mode switch in a 24-hour period due
to atrial rates of more than 180 beats per minute. The primary endpoint was
incidence of a thromboembolic event (stroke, transient ischemic attack,
peripheral arterial embolism). Secondary endpoints were cardiovascular death
and hospitalization because of AF or worsening HF. The mean study follow-up was
370 days.
“Most significantly,” Sack continued, “this analysis found
that patients with detected AHRE of more than 3.8 hours over 24 hours were at
significantly higher risk, as they were 9 times more likely to develop thromboembolic complications and 4 times more likely to die
from a cardiovascular cause compared to patients without AHRE.”
“This study emphasizes the potential importance of constant
monitoring of patients clinical status by devices with remote connectivity.
Systems that rely on episodic interrogation or without appropriate alerts may
delay recognition of risk situations by months,” commented Dr. Vince Paul, Department
of Cardiology, Royal Perth Hospital,
Australia, and
co-author of the paper.
The study results support a workflow where routine
assessment of AHRE with BIOTRONIK Home Monitoring® should be considered with other
data when determining stroke risk and planning anticoagulation initiation-and
should also prompt the optimization of cardioprotective HF therapy in CRT
patients. BIOTRONIK Home Monitoring® is a uniquely advantageous tool for
enhancing patient care because it is the only remote management system that
continuously monitors clinical and device status.
In order to investigate the clinical benefit of using the
unique early detection capabilities of BIOTRONIK Home Monitoring® to guide
anticoagulation therapy in ICD and CRT patients, BIOTRONIK is further
sponsoring the landmark IMPACT trial2. With planned enrollment of more
than 2,700 patients with an expected follow-up period of 36 months, IMPACT
investigates whether the risk for stroke, systemic embolism and major bleeding
can be reduced through initiation and withdrawal of anticoagulation therapy
based on BIOTRONIK Home Monitoring® information.
“The IMPACT clinical trial may hold the key for improving
patient outcomes with regards to reducing the risk of stroke with the unique
early detection and continuous monitoring capabilities offered by BIOTRONIK
Home Monitoring®,” commented Dr. Werner Braun, Managing Director, BIOTRONIK.
“The results of IMPACT have the potential to significantly change clinical
practice and improve patient outcomes by effectively guiding clinical
decision-making regarding anticoagulation therapy.”
About BIOTRONIK Home Monitoring®
BIOTRONIK Home Monitoring® is the first and only remote patient management
system with FDA and CE approvals for safe reduction of in-office follow-ups and
for early detection of clinically relevant events, leading to earlier
intervention, based on results of the TRUST landmark trial3-4. The system is
unique because it allows continuous automatic wireless remote monitoring of
patient and device status with daily updates, all independent from any patient
interaction. BIOTRONIK Home Monitoring® has pioneered advances in remote
patient management since its first clinical application in the year 2000.
Today, BIOTRONIK Home Monitoring® is extensively used in a growing number of
patients in more than 3,800 clinics and 55 countries worldwide.
About BIOTRONIK SE & Co. KG
As one of the worlds leading manufacturers of cardiovascular medical devices,
with several million devices implanted, BIOTRONIK is represented in over 100
countries by its global workforce of more than 5,600 employees. Known for
having its finger on the pulse of the medical community, BIOTRONIK assesses the
challenges physicians face and provides the best solutions for all phases of
patient care, ranging from diagnosis to treatment to patient management.
Quality, innovation and reliability define BIOTRONIK and its growing
success-and deliver confidence and peace of mind to physicians and their
patients worldwide. More information: www.biotronik.com
References:
1 Shanmugam N et al., Europace 2011. doi:10.1093/europace/eur293.
2 Ip J et al., Am Heart J 2009; 158:364-370
3 Varma N et al., Circulation 2010, 122, 325–332
4 Varma N et al., Circ Arrhythm Electrophysiol 2010, 3:428–436
Posted by Sean Fenske, Editor-in-Chief, MDT
