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Medtronic, Inc.
today released study findings that show heart failure patients who have
limited options for implanted device therapy may benefit from a novel implant
technique for cardiac resynchronization therapy (CRT) devices. Data from the
ALSYNC (Alternate Site Cardiac Resynchronization) study show that pacing from
inside the heart's left ventricle - an alternate site compared to traditional
implants - was successful in 89 percent of implant attempts. The data were
presented during a Late-Breaking Clinical Trials Session at Heart Rhythm 2014,
the Heart Rhythm Society's 35th Annual Scientific Sessions, by Prof. John
Morgan, M.D., Southampton University Hospitals Trust, Southampton, U.K. The
system evaluated in the ALSYNC study is not available for investigational or
commercial use in the United States.
Some heart failure patients are not suitable for, or do not respond to,
traditional CRT because of limitations associated with implanting a lead, or
thin wire, in veins on the outside of the left ventricle; these limitations
may include unique patient anatomy or suboptimal lead placement. As a
potential alternative for these patients, the system evaluated in the study
implants a lead placed inside the left ventricle by crossing the atrial
septum, the wall that divides the two top chambers of the heart.
"There is a significant need for a new way to pace the left ventricle in
patients unable to receive the clinical benefits of standard CRT therapy, and
this study suggests left ventricular endocardial pacing is a feasible option,"
said Prof. Morgan, lead investigator of the ALSYNC study. "These findings will
elevate this new approach from something that is investigational to one that
is closer to the mainstream."
The ALSYNC study, the first of its kind to evaluate the safety and performance
of a new delivery system and left ventricular endocardial (LVE) pacing lead
for CRT implantation, included 138 patients at 18 centers in Europe and
Canada, all of whom were indicated for CRT but were unable to receive a
conventional system or did not respond to the therapy at least six months
post-implant. LVE pacing was successful in 118 out of 133 (89 percent) implant
attempts.
The ALSYNC study assessed the safety and performance of the system and implant
procedure. The primary objective was to demonstrate that the complication
rates were less than 30 percent at six months in patients with an implant
attempt. The objective was met with an observed rate of 17.7 percent (upper
confidence bound 24.2 percent), which is comparable to the complication rates
of conventional CRT implants^1.
"As the leader in CRT, we are committed to continued innovations in heart
failure treatment and bringing renewed hope to the many patients who have
previously had limited options," said David Steinhaus, M.D., vice president
and general manager, heart failure, and medical director for the Cardiac
Rhythm Disease Management 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 that deliver clinical and economic value to healthcare consumers and
providers around the world.
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