Data Show Medtronic Quadripolar CRT Technology Optimizes Treatment for Heart Failure Patients
May 18 2015 - 9:00AM
Positive Results
from Two Studies Featured at Heart Rhythm Society 36th Annual
Scientific Sessions
DUBLIN and BOSTON - MAY 18,
2015 -Medtronic plc (NYSE: MDT) today announced study results
demonstrating that its quadripolar cardiac resynchronization
therapy (CRT) system gives physicians more options to optimize CRT
delivery, which may improve heart failure patients' response to the
therapy. During Heart Rhythm 2015, the Heart Rhythm Society's
36th Annual
Scientific Sessions in Boston, data from the Attain® Performa®
Quadripolar Lead Clinical Study revealed the clinical benefits
associated with steroid on all four electrodes. A separate analysis
demonstrated the importance of assessing pacing vectors over time.
VectorExpress(TM) technology, an easy-to-use tool found on
Medtronic Viva® Quad CRT-defibrillators, provides clinically
actionable information to help physicians select and maintain the
optimal pacing configurations - at implant and in follow-up visits
- for each patient, in only two minutes.
"When physicians pair Attain Performa leads with
Viva Quad devices and the AdaptivCRT technology to treat their
heart failure patients, they have more options to optimize therapy
delivery and personalize treatment," said David Steinhaus, M.D.,
vice president and general manager, Heart Failure, and medical
director for the Cardiac Rhythm and Heart Failure business, which
is part of the Cardiac and Vascular Group at Medtronic. "These new
data support the clinical benefits of CRT technology and add to the
body of evidence supporting Medtronic quadripolar leads and CRT
devices as an important therapy option for patients with heart
failure."
Effectiveness of Steroid-Eluting Electrodes on
Quadripolar LV Leads
Results from an analysis of the Attain Performa Quadripolar Lead
Clinical Study showed that the inclusion of steroid on all four
electrodes in these quadripolar left ventricular (LV) leads
stabilized pacing capture thresholds (PCTs) and impedance values
over time. PCT is the level of energy the device must expend in
order to pace the heart. The data, on 960 patients followed at six
months, showed that steroid elution was effective on all vectors
and that the greatest benefit was found at more proximal sites.
These results suggest that the use of steroids may provide greater
opportunities for basal pacing (near the top of the heart),
avoiding phrenic nerve stimulation (PNS) and prolonging generator
longevity.
Steroid on all electrodes led to a statistically
significant reduction in PCTs compared to leads without steroid on
all electrodes (p<0.0001). These lower thresholds give
physicians more usable options to achieve optimal pacing while
improving longevity.
"While we have known that steroid-eluting
electrodes on cardiac leads are important for chronic cardiac lead
performance, this is the first study to demonstrate the benefits of
steroid-elution on all quadripolar electrodes of a left ventricular
lead. The Performa left ventricular lead is unique in having four
steroid eluting electrodes, which enables more choices when
programming the device, may improve CRT delivery, may reduce
complications of left ventricular pacing, and will give peace of
mind over the chronic performance of the Performa lead," said
Albert Lin, M.D., electrophysiologist at Northwestern Memorial
Hospital and associate professor at Northwestern University
Feinberg School of Medicine, Chicago.
Serial Post-Implant LV Vector Selection and Device
Longevity
A separate analysis from the Attain Performa Quadripolar Lead
Clinical Study demonstrated the importance of assessing pacing
vectors over time. VectorExpress technology was used to measure
left ventricular PCTs and impedance in all 16 pacing vectors at
implant, three months, six months and 12 months post-implant, to
determine whether the selected pacing vector remained optimal. Over
the course of 12 months of follow up, approximately 40 percent (of
824) patients' optimum pacing vector changed, demonstrating that
pacing vectors need to be assessed and optimized on a regular
basis.
"We are just beginning to understand the potential
value of advancements in resynchronization therapy like quadripolar
LV leads and automated software tools. For example, the
VectorExpress tool offers robust method of assessing pacing capture
and impedance data from all 16 vectors of a quadripolar lead in
under 3 minutes," said Derek Exner, M.D., Professor, Libin
Cardiovascular Institute of Alberta, Canada. "Using this
VectorExpress data we can substantially enhance battery longevity
and improve patient outcomes."
About the Attain Performa® Quadripolar Lead
Porfolio and Viva CRT-Ds
The Attain Performa LV quadripolar lead portfolio includes three
lead shapes (Dual Cant, S-Shape and Straight) with steroid on all
electrodes and shorter spacing between the two center electrodes.
These features, which are exclusive to the Attain Performa leads,
give physicians more options to treat varying patient anatomies
while also reducing the incidence of PNS, a potential side effect
associated with CRT therapy that results in muscle twitching,
hiccups or shortness of breath.i
All three Attain Performa leads are compatible
with the company's newest portfolio of CRT devices, the Viva Quad
XT and Viva Quad S CRT-D systems. The Viva Quad XT CRT-D also
features the AdaptivCRT® algorithm. Recent data from a study
published in the Journal of the American College
of Cardiology: Heart Failure showed that the AdaptivCRT
algorithm was associated with a significant relative reduction in
both all cause 30-day readmissions (46 percent) and heart failure
30-day readmissions (59 percent), when compared to echo-optimized
CRT.
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 the global leader in medical technology - alleviating
pain, restoring health and extending life for millions of people
around the world.
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 -
i Biffi et
al. Effort of Bipolar Electrode Spacing on Phrenic Nerve
Stimulation and Left Ventricular Pacing Thresholds: An Acute Canine
Study. Circulation Arrhythmia and Electrophysiology. 2012.
Contacts:
Tracy McNulty
Public Relations
+1-763-526-2492
Jeff Warren
Investor Relations
+1-763-505-2696
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Source: Medtronic plc via Globenewswire
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