Findings
Demonstrate Detection of Atrial Fibrillation in Cryptogenic Stroke
Patients with Medtronic Insertable Cardiac Monitor
DUBLIN and VANCOUVER - APRIL 20,
2016 - Medtronic plc (NSYE: MDT) today announced one-year
results from a real-world study of patients who had a cryptogenic
stroke, or stroke of unknown cause. The study found that the Reveal
LINQ(TM) Insertable
Cardiac Monitor (ICM) detected atrial fibrillation (AF) at a
greater rate than previously reported in a randomized controlled
clinical trial (the CRYSTAL AF Study, published in The New England Journal of Medicine in 2014). The
results from the observational real-world study are being presented
today at the 68th American
Academy of Neurology Annual Meeting in Vancouver, Canada.
The study evaluated 1,247 patients across the U.S. to understand
the incidence and duration of AF episodes in a large, real-world
population of cryptogenic stroke patients with an ICM after one
year of follow up and to compare the AF detection rates among these
patients to those of the CRYSTAL AF Study. At 12 months, 1,737 AF
episodes were detected in 192 patients, resulting in an AF
detection rate of 16.3 percent. This represents a 32 percent
relative increase compared to the rate observed in the CRYSTAL AF
Study at the same time.
The current recommended guidelines for AF
detection are 30-days of monitoring within six months of having a
cryptogenic stroke. However, because AF may occur infrequently, it
may not be detected by conventional monitoring techniques such as
in-hospital monitoring, electrocardiography or traditional
ambulatory cardiac monitors such as a Holter. The real-world study
found that 72 percent of patients diagnosed with AF would have been
undiagnosed if their cardiac monitoring had been limited to 30
days.
"In clinical practice, we continue to see
increased AF detection rates using the insertable cardiac monitor
compared to the rigorously-controlled CRYSTAL AF study," said
co-author John Rogers, M.D., cardiologist at Scripps Clinic in La
Jolla, California. "What's most significant, however, is that the
vast majority of patients had their first AF episode beyond the
range of 30-day conventional monitoring, reinforcing the need to
reevaluate the standard AF monitoring guidelines for cryptogenic
stroke patients."
Each year, approximately 692,000 Americans
experience ischemic strokes (the most common type of stroke);
cryptogenic strokes account for approximately 20 - 40 percent of
ischemic strokes in the majority of modern stroke registries and
databases.1-7 Patients
with AF - a common cardiac condition that occurs when the heart
beats irregularly or rapidly - are five times more likely to have a
stroke.8
The Reveal LINQ ICM System is the smallest
insertable cardiac monitoring device available (~1 cc, or one-third
the size of an AAA battery). Placed just beneath the skin through a
small incision of less than 1 cm in the upper left side of the
chest, the Reveal LINQ ICM is inserted using a minimally invasive
procedure and its presence is often nearly undetectable to the
naked eye once the incision has healed. The device communicates
wirelessly with a patient bedside monitor that uploads device data
to the Medtronic CareLink® network and
is MR-Conditional, allowing patients to undergo magnetic resonance
imaging (MRI), if needed. The Reveal LINQ ICM automatically and
continuously detects and records abnormal heart rhythms for up to
three years.
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,
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 85,000 people worldwide, serving physicians,
hospitals and patients in approximately 160 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.
-end-
1
Sacco RL, Ellenberg JH, Mohr JP, et al. Infarcts of undetermined
cause: the NINCDS Stroke Data Bank. Ann
Neurol. 1989;25:382-390.
2
Petty GW, Brown RD, Jr., Whisnant JP, Sicks JD, O'Fallon WM, et al.
Ischemic stroke subtypes: a population-based study of incidence and
risk factors. Stroke. 1999;30:2513-2516.
3
Kolominsky-Rabas PL, Weber M, Gefeller O, Neundoerfer B, Heuschmann
PU. Epidemiology of ischemic stroke subtypes according to TOAST
criteria: incidence, recurrence and long-term survival in ischemic
stroke subtypes: a population-based study. Stroke. 2001;32:2735-2740.
4
Schulz UG, Rothwell PM. Differences in vascular risk factors
between etiological subtypes of ischemic stroke: importance of
population-based studies. Stroke.
2003;34:2050-2059.
5
Schneider AT, Kissela B, Woo D, et al. Ischemic stroke subtypes: a
population-based study of incidence rates among blacks and whites.
Stroke. 2004;35:1552-1556.
6
Lee BI, Nam HS, Heo JH, Kim DI. Yonsei Stroke Registry. Analysis of
1,000 patients with acute cerebral infarctions. Cerebrovasc Dis. 2001; 12:145-151.
7
Heart Disease and Stroke Statistics 2015 Update Circulation. 2015; 131: e29-e322 Published online
before print December 17, 2014, doi:
10.1161/CIR.0000000000000152.
8
Wolf PA, et al. Stroke. 1991; 22: 983-988.
Contacts:
Ryan Mathre
Public Relations
+1-651-335-2338
Ryan Weispfenning
Investor Relations
+1-763-505-4626
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information contained therein.
Source: Medtronic plc via Globenewswire
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