Medtronic-Sponsored Study Indicates Bi-Ventricular Pacing Superior to Right Ventricular Pacing in Avoiding Cardiac Enlargement

Sun Nov 15, 2009 4:00pm EST
 
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Early Results Show Preserved Heart Size in Pacemaker Patients with Normal Left
Ventricles
MINNEAPOLIS & ORLANDO, Fla.--(Business Wire)--
Pacing the two lower chambers of the heart, or bi-ventricular pacing, prevented
cardiac enlargement as compared to only pacing the right ventricle in pacemaker
patients with normal pumping hearts, according to results presented today from
the Pacing to Avoid Cardiac Enlargement (PACE) trial, a clinical study supported
by Medtronic, Inc. (NYSE: MDT). Bi-ventricular pacing is proven to reduce
symptoms, extend survival and reduce heart size in symptomatic heart failure
patients; however, it is not currently approved for use with pacemaker patients
with normal pumping hearts. PACE data were presented today as a late-breaking
clinical science session at the Scientific Sessions 2009, the annual congress of
the American Heart Association in Orlando, Fla. and published online in the New
England Journal of Medicine. 

Meeting its primary objective, PACE results showed that after one year of
pacing, patients with pacing in both right and left ventricles (bi-ventricular)
had no significant changes in left ventricle size while patients paced only in
the right ventricle developed enlarged left ventricles. Adverse changes in
patients paced only in the right ventricle included:

* A significant increase of 6.3 milliliter on average in the size of the left
ventricle at the end contraction, and 
* A decrease of 6.8 percent in the ejection fraction, or the amount of available
blood pumped from the left ventricle.

"These early results show bi-ventricular pacing may be superior to pacing only
in the right ventricle to preserve the heart`s normal left ventricle size and
pumping ability for these pacemaker patients," said Cheuk-Man Yu, M.D. professor
of medicine at Prince of Wales Hospital, The Chinese University of Hong Kong in
China and PACE lead investigator. "As the first randomized study with this
patient population, these initial results suggested that ensuring synchrony of
the ventricles can help maintain patient health." 

"Clinical evidence shows delivering pacing only when and where patients need it
is important to improving the care of pacemaker patients," said Marshall
Stanton, M.D., vice president of clinical research for the Cardiac Rhythm
Disease Management business at Medtronic. "With the Medtronic-exclusive pacing
mode MVP®, Managed Ventricular Pacing, which is the only technology available
that reduces unnecessary right ventricular pacing by 99 percent, and the ongoing
BLOCK-HF bi-ventricular pacing study, Medtronic is dedicated to offering
physicians the latest tools and clinical evidence to help physicians deliver
appropriate care to their pacemaker patients." 

About PACE
The PACE study is a prospective, randomized, double-blind, parallel study
enrolling 177 patients at four hospitals in Asia. Patients had a Medtronic
Insync III cardiac resynchronization therapy-pacemaker (CRT-P), or
bi-ventricular pacemaker without defibrillation, and had no prior history of
heart failure with normal left ventricle function and ejection fraction greater
than or equal to 45 percent. Patients were evaluated at one, three, six, nine
and 12 months. 

About Cardiac Resynchronization Therapy
Cardiac resynchronization therapy (CRT), also known as bi-ventricular pacing, is
a treatment for heart failure that uses an implantable device to improve the
pumping efficiency of the heart. A cardiac resynchronization therapy-pacemaker
(CRT-P), is a stopwatch-sized device implanted in the upper chest to
resynchronize (without defibrillation) the contractions of the ventricles by
sending tiny electrical pacing impulses to the heart muscle to help the heart
pump blood throughout the body more efficiently and reduce symptoms. Cardiac
resynchronization therapy is intended to complement standard drug treatment, and
dietary and lifestyle modifications. 

About Medtronic
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global
leader in medical technology - alleviating pain, restoring health and extending
life for millions of people around the world. 

Caution: The CRT-P devices used in the PACE trial are investigational for the
patient population studied; their use is limited by federal (or United States)
law to investigational use for this indication.

Any forward-looking statements are subject to risks and uncertainties such as
those described in Medtronic`s Annual Report on Form 10-K for the year ended
April 24, 2009. Actual results may differ materially from anticipated results.

Medtronic, Inc.
Public Relations:
Catherine Peloquin, 763-526-2494
or
Investor Relations:
Jeff Warren, 763-505-2696 



Copyright Business Wire 2009

 

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