DUBLIN, Oct. 4, 2021 /PRNewswire/ -- Medtronic plc
(NYSE: MDT), the global leader in medical technology, today
announced the publication of a study demonstrating, through the use
of a Medtronic continuous rhythm monitoring device, that atrial
fibrillation (AF) is directly and transiently associated with
ischemic stroke. The findings were published online on September 29 in JAMA Cardiology.
Stroke impacts more than 795,000 people every year. More than
87% of strokes are ischemic strokes, which occur when vessels that
allow blood to flow to the brain are blocked.1 AF is a
major risk factor for ischemic stroke, increasing risk of stroke
5-fold compared with those patients who do not have
AF.2
This retrospective case-crossover study leveraged data from
466,635 patients included in both the Optum deidentified electronic
health record (EHR) and the Medtronic CareLink™ network databases.
Of those, a total of 891 patients with Medtronic cardiovascular
implantable electronic devices (CIEDs) capable of continuous rhythm
monitoring sustained both an ischemic stroke and received 120 days
of continuous monitoring prior to their stroke. A threshold of AF
exposure was defined as AF lasting 5.5 hours or more on any given
day. Patients were evaluated during a case period that included
days 1 to 30 prior to the index stroke and a control period that
included days 91 to 120 prior to the event. It was found that 76.5%
(682/891) subjects had no AF meeting the threshold in either 30-day
period, 16% (143/891) had at least one day with 5.5 hours or more
of AF in both periods, and 7.4% (66/891) had informative,
discordant rhythm patterns (defined as those that had AF exceeding
5.5 hours in only one period). Key findings were as follows:
- Among patients with CIEDs with informative, discordant rhythm
patterns, having AF of 5.5 hours or more raised the 30-day risk of
ischemic stroke more than three-fold.
- Stroke risk was highest within five days of a 5.5 hour or more
episode of AF and diminished rapidly thereafter.
- A temporal association between AF and stroke was not seen in
patients who had been prescribed oral anticoagulants (OACs).
"Overall, these findings significantly underscore traditional
thinking that AF is likely a causal risk factor for ischemic stroke
as opposed to just a risk marker," said Daniel Singer, M.D., professor of medicine at
Harvard Medical School, professor in
the Department of Epidemiology at the Harvard T.H. Chan School of
Public Health, and Division of General Internal Medicine at
Massachusetts General Hospital. "The results indicate that
prolonged episodes of AF increase stroke risk, but this risk
decreases rapidly following the end of the episode. These
findings raise the possibility that time-limited anticoagulation
for infrequent episodes of AF may be an effective stroke prevention
strategy."
In this study, subjects evaluated had Medtronic CIEDs capable of
continuous heart rhythm monitoring via the Medtronic CareLink™
network, including 114 patients with Medtronic insertable cardiac
monitors (ICMs) and 777 with various Medtronic transvenous devices
with atrial leads, including implantable cardioverter
defibrillators (ICDs), cardiac resynchronization therapy (CRT)
devices, and pacemakers.
"As of late, there has been significant discussion surrounding
the temporal relationship of AF episodes to stroke, as well as the
use of continuous cardiac monitoring, specifically with ICMs, to
detect clinically meaningful AF episodes that may lead to a
stroke," said Rob Kowal, M.D.,
Ph.D., chief medical officer of the Cardiovascular Diagnostics and
Services business, which is part of the Cardiovascular Portfolio at
Medtronic. "This evidence highlights that patients are at highest
risk for a stroke within five days of an AF episode that lasts five
and a half hours or more. In addition to supporting the use of OACs
in this patient population, this study also suggests the value of
long-term cardiac monitoring to accurately detect these critical AF
episodes."
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 of the highest
quality that deliver clinical and economic value to healthcare
consumers and providers around the world.
About Medtronic
Medtronic plc (www.medtronic.com),
headquartered in Dublin, Ireland,
is among the world's largest medical technology, services and
solutions companies – alleviating pain, restoring health and
extending life for millions of people around the world. Medtronic
employs more than 90,000 people worldwide, serving physicians,
hospitals and patients in more than 150 countries. The company is
focused on collaborating with stakeholders around the world to take
healthcare Further, Together.
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.
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1
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Virani SS, Alonso A,
Benjamin EJ, Bittencourt MS, Callaway CW, Carson AP, et al. Heart
disease and stroke statistics—2020 update: a report from the
American Heart Associationexternal icon. Circulation.
2020;141(9):e139–e596.
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2
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Wolf PA, Abbott
RD, Kannel WB. Atrial fibrillation as an independent risk factor
for stroke: the Framingham Study. Stroke.
1991;22:983-988.
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