Medtronic Study Detects Gene Associated with Sudden Cardiac Death
August 31 2015 - 7:04AM
First-of-its-Kind
Discovery Furthers Understanding of Role of Genetics in Sudden
Cardiac Death, May Help Identify Patients at Increased Risk
DUBLIN and LONDON - August 31,
2015 - Medtronic plc (NYSE: MDT) today announced
first-of-its-kind findings from two independent studies that have
identified a gene associated with life-threatening abnormal heart
rhythms. The study results were presented in a hotline session at
the 2015 European Society of Cardiology (ESC) Congress in
London.
The studies evaluated genetic "markers" to
determine which gene abnormalities may be associated with dangerous
heart rhythms that can lead to sudden cardiac death (SCD).
The initial Medtronic DISCOVERY (Diagnostic Data Influence on
Disease Management and Relation of Genetic Polymorphisms to
Ventricular Tachyarrhythmia in ICD Patients) trial identified a
gene associated with SCD in patients with implantable cardioverter
defibrillators (ICDs), and the second study, Oregon Sudden
Unexpected Death Study (Oregon SUDS), confirmed this finding in the
general population.
The DISCOVERY trial used ICDs to monitor patients
for abnormal heart rhythms and then identified the gene associated
with a 50 percent relative risk increase in these life-threatening
heart rhythms. These results were confirmed by the
Oregon-Sudden Unexpected Death Study (Oregon-SUDS), a
community-based study that analyzed causes of SCD.
"This research is vital to helping us better
understand why some patients are at higher risk of sudden cardiac
death, one of the leading causes of death globally," said Sumeet
Chugh, M.D., associate director of the Cedars Sinai Heart Institute
and lead investigator for Oregon SUDS. "These findings put us one
step closer to understanding the complexities of sudden cardiac
death and may, someday, help us identify which patients are at
risk."
Patients with these life-threatening abnormal
heart rhythms experience abrupt loss of heart function that leads
to death if they are not treated immediately. An ICD is a small
implantable device that is placed under the skin to continuously
monitor the heart; if it detects a severe abnormal heart rhythm,
known as ventricular arrhythmia, it delivers therapy to restore a
normal heartbeat.
"This is the first time a gene has been identified
using ICD monitoring and then confirmed to be associated with
sudden cardiac death in the general population," said Professor
Heiner Wieneke, principal investigator of the DISCOVERY trial and
chief physician in the Department of Cardiology, Contilia Heart and
Vessel Centre, St. Marien-Hospital Mülheim, Germany. "These
findings are a first step to learning more about how to determine
better ways to prevent and treat this condition."
The two-part presentation started with the
DISCOVERY trial, a prospective, multicenter study of 1,145 patients
that investigated the association of single nucleotide
polymorphisms (SNPs, a genetic variation) with the occurrence of
ventricular arrhythmias in patients receiving ICDs for primary
prevention of sudden cardiac death. Data showed that the gene GNAS
holds two SNPs (c.2273C>T and c.393C>T) that were associated
with an increased risk for ventricular tachyarrhythmias (VT) as
identified by the ICDs.
In the second part of the analysis, the database
of blood samples collected from 1,335 patients in the Oregon-SUDS
trial was reviewed for the presence of SNPs identified in the
DISCOVERY trial. During the validation phase, c.393C>T was found
to be associated with an increased risk for SCD in a general
population under both additive (odds ratio [OR] =1.2 [1.0-1.4],
p=0.039) and recessive (OR=1.5 [1.1-2.1], p=0.01) genetic models.
The study confirmed that this SNP was associated with a 50
percent increased risk of SCD.
"The results presented today are part of
Medtronic's efforts to better identify people at risk of SCD and to
get them the right life-saving therapy," said Marshall Stanton,
M.D., vice president and general manager of Tachycardia in the
Cardiac Rhythm and Heart Failure Business at Medtronic. "Medtronic
looks forward to partnering with the larger clinical research
community to further our shared understanding of the risk for
sudden cardiac death and how to prevent it."
About the
DISCOVERY Trial: The DISCOVERY Trial investigated if 7 single
nucleotide polymorphisms (SNPs) in 3 genes coding G-protein
subunits were predictive of ventricular tachyarrhythmias (VT) and
SCD. The study was conducted in 91 European centers between April
2007 and June 2011, and is sponsored by Medtronic.
About the Oregon Sudden
Unexpected Death (SUDS) Study: Oregon SUDS is a community-based
SCD study in Portland being conducted by the Arrhythmia Research
Laboratory at the Cedars-Sinai Heart Institute, Los Angeles. For
more than 12 years, the study has collected detailed information on
sudden cardiac arrest (SCA) cases, including blood samples to
investigate genetic and biochemical markers of risk. The study
receives support from the National Heart, Lung and Blood Institute
(NHLBI) and the American Heart Association.
In collaboration with leading clinicians,
researchers and scientists worldwide, Medtronic offers the broadest
range of innovative medical technology for the interventional and
surgical treatment of cardiovascular disease and cardiac
arrhythmias. The company strives to offer products and services
that deliver clinical and economic value to healthcare consumers
and providers around the world.
About Medtronic
Medtronic plc (www.medtronic.com), headquartered in Dublin, is the
global leader in medical technology - alleviating pain, restoring
health and extending life for millions of people around the
world.
Any forward-looking
statements are subject to risks and uncertainties such as those
described in Medtronic's periodic reports on file with the
Securities and Exchange Commission. Actual results may differ
materially from anticipated results.
- end -
Contacts:
Kathleen Janasz
Public Relations
+1-612-743-8995
Ryan Weispfenning
Investor Relations
+1-763-505-4626
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Source: Medtronic plc via Globenewswire
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