ST. PAUL,
Minn.–(BUSINESS WIRE)–St. Jude Medical, a global medical device company, today announced the publication of
results from the ASSERT cohort study in the New England Journal of Medicine
(NEJM). The ASSERT study, or ASymptomatic AF and Stroke Evaluation in Pacemaker
Patients and the AF Reduction Atrial Pacing Trial, was designed to determine
whether the detection of arrhythmias using pacemaker-based diagnostics predicts
an increased risk of stroke in elderly, hypertensive patients without any
history of atrial fibrillation (AF).

The study results, previously presented at an American Heart
Association Scientific Sessions meeting, found that pacemaker patients who have
no history of atrial tachycardia (AT) or AF, but do have device-detected
arrhythmias, are approximately 2.5 times more likely to have a stroke than
patients who do not have device-detected arrhythmias. The trial was sponsored
by St. Jude Medical and was conducted by the Population Health Research
Institute of McMaster University and Hamilton Health Sciences in Hamilton, Canada.

“Approximately 85 percent of atrial arrhythmias documented
in the study were picked up only by the pacemaker, proving the device plays a
very significant role in identifying patients with a higher risk of stroke,”
said Dr. Jeff S. Healey, principal investigator for the arrhythmias program at
the Population Health Research Institute. “This monitoring technology is a
built-in diagnostic tool and a huge value-add to further assist physicians in
properly treating their patients.”

The study included 2,580 pacemaker and ICD patients over the
age of 65 with hypertension and no history of AF. Subclinical (non-symptomatic)
atrial tachyarrhythmias detected by implanted devices occurred in over 10
percent of patients at three months. The risk of systemic embolism (or stroke) associated
with non-symptomatic atrial tachyarrhythmias was 13 percent. The diagnostic
data and alerts available through St. Jude Medical implantable devices allow
physicians and patients to be notified whenever a patient experiences
significant atrial arrhythmias (abnormal heartbeats) in the heart’s upper
chambers, such as AT or AF.

“The publication of these findings reminds us how important
it is to identify patients with an increased risk of stroke. Diagnostic tools
and remote monitoring capabilities already found in St. Jude Medical pacemakers
and ICDs make it easier for physicians to capture information to manage AT and
AF even when the arrhythmias are not accompanied by symptoms,” said Dr. Mark
Carlson, chief medical officer and senior vice president of research and
clinical affairs for the St. Jude Medical Cardiac Rhythm Management Division.
“St. Jude Medical is committed to providing our customers with clinically
relevant information that allows them to deliver more timely and effective care
to patients around the world.”

About Atrial Fibrillation

Atrial fibrillation (AF) is a chaotic, uncontrolled heart rhythm. It occurs
when the upper chambers of the heart (atria) contract rapidly and irregularly –
from 350 to 600 times per minute compared to a normal heart rhythm of 60 to 100
times per minute. AF is known to be a common risk factor for, and cause of,
stroke. Because the atria contract so rapidly and irregularly during AF, the
heart cannot beat effectively and blood is not pumped completely out of the
atria. Blood that pools in the atria may clot and, if the clot moves to an
artery in the brain, stroke may occur. Studies show that AF increases the risk
of stroke five-fold. The risk for stroke related to AF increases with age, and
AF potentially leads to a range of other debilitating symptoms as well.

About St. Jude Medical

St. Jude Medical develops medical technology and services that focus on putting
more control into the hands of those who treat cardiac, neurological and
chronic pain patients worldwide. The company is dedicated to advancing the
practice of medicine by reducing risk wherever possible and contributing to
successful outcomes for every patient. St. Jude Medical is headquartered in St. Paul, Minn.
and has four major focus areas that include: cardiac rhythm management, atrial
fibrillation, cardiovascular and neuromodulation. For more information, please
visit sjm.com.

Posted by Sean Fenske, Editor-in-Chief, MDT