Clinical Practice
Guidelines from European Society of Cardiology 2016 Reinforce
Benefits of Cryoballoon Ablation and Long-Term Cardiac
Monitoring
DUBLIN - September 12, 2016
- Two Medtronic plc (NYSE: MDT) innovations were
acknowledged in updated guidelines published by the European
Society of Cardiology (ESC): cryoballoon ablation for patients with
diagnosed atrial fibrillation (AF), and long-term cardiac
monitoring for survivors of stroke who do not have an established
diagnosis of AF.
The Clinical Practice Guidelines on Atrial
Fibrillation were issued by the ESC at its meeting in Rome, and
were developed in collaboration with the European Association for
Cardio-Thoracic Surgery (EACTS). The guidelines also were published
online in the European Heart Journal and the
European Journal of Cardio-Thoracic
Surgery.
Cryoballoon Ablation for Patients
with Atrial Fibrillation
ESC's guidelines now recognize the strong evidence
supporting the use of pulmonary vein isolation as the preferred
ablation intervention for patients with AF. Catheter ablation is
recommended as the first-line treatment in select patients*, with
cryoenergy as effective as radio frequency energy for isolating the
pulmonary veins.
More than 400 peer-reviewed publications on
Cryoballoon ablation, including the landmark FIRE AND ICE Trial
published in The New England Journal of
Medicine and European Heart Journal, and
the STOP AF pivotal trial, have reported on the clinical experience
of the cryoballoon.
The new ESC Guidelines on Ablation for Atrial
Fibrillation Patients state, "Catheter Ablation is recommended as a
first-line treatment in selected patients after research showed it
was not less safe than antiarrhythmic drugs."
More than 220,000 patients have been treated with
Medtronic cryoballoon ablation worldwide.
Long-term Cardiac Monitoring for
Stroke Patients Without a Diagnosis of AF
The new ESC guidelines support screening for AF
with long-term cardiac monitoring in patients who have had an
ischemic stroke, the most common type of stroke (approximately 85
percent of all strokes). Ischemic strokes are caused when an
obstruction in a blood vessel prevents adequate blood flow to the
brain.
The benefits of long-term cardiac monitoring in
stroke are supported by a strong body of clinical evidence. The
CRYSTAL AF Study, which was published in the June 2014 issue of
The New England Journal of Medicine, found
that long-term cardiac monitoring with the Reveal® Insertable
Cardiac Monitor (ICM) detected AF at a rate of more than seven
times higher than standard care (at one year) in patients with an
unknown cause of stroke. Also, recent data presented at the 2016
American Academy of Neurology Annual Meeting showed that in a
real-world population of these stroke patients, 72 percent of AF
patients would have gone undiagnosed if cardiac monitoring had been
limited to only 30 days.
According to the new ESC Clinical Practical
Guidelines on AF, prolonged monitoring "seems reasonable in all
survivors of an ischemic stroke without an established diagnosis of
AF."
"Because AF often has no symptoms and may occur
infrequently, we have advocated for continuous long-term monitoring
as the standard of care for detecting AF in these patients," said
John Camm, professor of clinical cardiology at St. George's
University of London. "We look forward to raising awareness about
this important guideline update so that patients everywhere have
access to the diagnostic tools they need so they can lead healthier
lives."
About Atrial Fibrillation
Atrial fibrillation is a common cardiac condition
in which the heart beats irregularly or rapidly; patients with AF
are five times more likely to have a stroke1 due
to small blood clots that may form in the heart and subsequently
travel to the brain. Worldwide, it is estimated that more
than 33.5 million people suffer from atrial fibrillation2.
"At Medtronic, one of our goals is to develop
industry-leading technologies, validated by clinical evidence, that
improve peoples' lives," said John Liddicoat, M.D., senior vice
president at Medtronic and president of the Cardiac Rhythm and
Heart Failure Division. "Cryoablation therapy and long-term cardiac
monitoring represent the meaningful innovations needed by patients
with diagnosed AF, and by patients who've had a stroke and don't
know if it was caused by AF but need to find out so they can be
treated effectively."
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 88,000 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-
* The Medtronic Arctic Front Advance(TM)
Cryoablation System is approved in the U.S. for the treatment of
drug-refractory, recurrent, symptomatic paroxysmal atrial
fibrillation and in Europe for the treatment of atrial
fibrillation.
1 Wolf PA, et
al. Stroke. 1991; 22: 983-988.
2 Chugh S,
Havmoeller R, Narayanan K, et al. Worldwide epidemiology of atrial
fibrillation: a global burden of disease 2010 study. Circulation.
2014; 129:837-847.
Contacts:
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Public Relations
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Ryan Weispfenning
Investor Relations
+1-763-505-4626
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Source: Medtronic plc via Globenewswire
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