New Guidelines Support Use of Cardiac Monitoring for Patients with Unexplained Fainting
25 March 2017 - 12:00AM
American College
of Cardiology, American Heart Association and Heart Rhythm Society
Jointly Issue First-Ever Syncope Guidelines that Reinforce Benefits
of Continuous Cardiac Monitoring
DUBLIN - March 24, 2017 -
Newly published guidelines from the American College of Cardiology
(ACC), the American Heart Association (AHA), and the Heart Rhythm
Society (HRS) recommend the use of cardiac monitors for evaluating
patients with unexplained fainting, called syncope. The "2017
ACC/AHA/HRS Guideline for the Evaluation and Management of Patients
with Syncope," was recently published online in the Journal of the American College of Cardiology, Circulation and HeartRhythm.1
Syncope is a sudden loss of consciousness that
occurs when blood pressure drops and not enough oxygen reaches the
brain, affecting 1.5 million people worldwide each year. Some
causes of unexplained fainting are harmless; however, heart-related
causes, including abnormal heart rhythms, are common and among the
most serious causes of syncope. Left untreated, cardiac syncope
doubles the risk of death and carries a six-month mortality rate of
greater than 10 percent.2
Medtronic offers cardiac monitors for patients
based on the frequency of symptoms or the nature of the syncope
events. The Medtronic SEEQ(TM) MCT System is a wireless,
continuous, external heart monitor that can be worn for up to 30
days to detect any irregular heartbeats. The Reveal LINQ(TM) ICM
with TruRhythm(TM) Detection allows physicians to continuously and
wirelessly monitor a patient's heartbeat for up to three years;
one-third the size of an AAA battery (~1 cc), it is placed just
beneath the skin through a small incision of less than 1 cm in the
upper left side of the chest using a minimally invasive procedure.
For the evaluation of syncope patients, the device offers exclusive
algorithms that result in a 95 percent reduction in false
bradycardia (slow heartbeat) episodes and a 47 percent reduction in
false pauses (brief absence of cardiac activity) episodes when
compared with its predecessor, the Reveal LINQ(TM)ICM.3
"The causes of syncope can be difficult to
diagnose as episodes are usually infrequent and unpredictable,"
said David Benditt, M.D., professor of medicine and co-director of
the Cardiac Arrhythmia Center at the University of Minnesota.
"Detection with short-term monitoring techniques is often
unsuccessful and, as a result, patients may see several different
specialists and undergo multiple tests without receiving a
conclusive diagnosis. When the cause of syncope is unclear,
continuous long-term cardiac monitoring has become the standard of
care, particularly in early stages of evaluation."
The new guidelines, intended to drive better
informed clinical decisions and improved patient outcomes, support
the use of cardiac monitoring in patients with unexplained syncope
with the strongest endorsement, stating: "The choice of a specific
cardiac monitor should be determined on the basis of the frequency
and nature of the syncope events." Both external and implantable
cardiac monitors are recommended based on symptom frequency in the
new guidelines. Implantable cardiac monitors have a stronger
recommendation as a result of the strong evidence and randomized
controlled trials that support the use of ICMs in unexplained
syncope patients.
The benefits of long-term cardiac monitoring with a Reveal® ICM in
syncope patients are supported by clinical evidence that
demonstrates superiority compared to conventional tests. As
evidenced by the PICTURE (Place of Reveal In the Care Pathway And
Treatment of patients with Unexplained Recurrent SyncopE) study,
long-term cardiac monitoring with Reveal ICMs led to diagnosis and
specific treatment for 78 percent (170 of 218) of patients who
experienced recurrent syncope. Of those diagnosed, 75 percent of
patients were shown to have had a cardiac cause of their syncopal
event. In addition, the study found that patients were evaluated by
an average of three different specialists for managing their
syncope and underwent a median of 13 inconclusive tests before a
Reveal ICM was implanted.
4 The Reveal
LINQ ICM may help reduce costs associated with these inconclusive
diagnostic tests while providing effective diagnoses for these
patients.
5
"Medtronic is committed to bringing meaningful
innovations that help patients lead healthier lives, while
providing clinicians with the best tools so that they can
efficiently and effectively diagnose and treat their patients,"
said Nina Goodheart, vice president and general manager of the
Patient Monitoring & Diagnostics business at Medtronic.
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-
1.
http://www.onlinejacc.org/content/early/2017/03/10/j.jacc.2017.03.002
2. Soteriades ES, et al. N Engl J
Med. 2002;347:878-885.
3. TruRhythm Detection Algorithms. Medtronic data
on file. 2017.
4. Edvardsson N, Frykman V, van Mechelin R, et al.
Use of an implantable loop recorder to increase the diagnostic
yield in unexplained syncope: results from the PICTURE registry.
Europace. February 2011;13(2):262-269.
5. Edvardsson N, Wolff C, Tsintzos S, Rieger G,
Linker NJ. Costs of unstructured investigation of unexplained
syncope: Insights from a micro-costing analysis of the
observational PICTURE registry. Europace. July
2015;17(7):1141-1148.
Contacts:
Ryan Mathre
Public Relations
+1-763-514-9625
Ryan Weispfenning
Investor Relations
+1-763-505-4626
This
announcement is distributed by Nasdaq Corporate Solutions on behalf
of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely
responsible for the content, accuracy and originality of the
information contained therein.
Source: Medtronic plc via Globenewswire
Medtronic (NYSE:MDT)
Historical Stock Chart
From Apr 2024 to May 2024
Medtronic (NYSE:MDT)
Historical Stock Chart
From May 2023 to May 2024