Medtronic plc 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.
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