2013-04-24 23:02:01 -
MINNEAPOLIS - April 24, 2013 - Biventricular (BiV) pacing with Medtronic, Inc.
(NYSE: MDT) cardiac resynchronization therapy (CRT) devices may offer a
significant clinical advantage and improved patient outcomes over conventional
right ventricular (RV) pacing among patients with left ventricular (LV) systolic
dysfunction and atrioventricular (AV) block who are indicated for a pacemaker.
Results from the Medtronic-sponsored BLOCK HF trial show a 26 percent relative
risk reduction in the composite of death, healthcare utilization visits
requiring intravenous (IV) heart failure therapy, and significant increase in
left ventricular end systolic volume index (LVESVi, a measure of cardiac
function) among the patients receiving BiV pacing. The results are published in
the April 25, 2013, edition of The New England Journal of Medicine.
Under current guidelines, patients with AV block and reduced pumping capacity
indicated for a dual or single chamber pacemaker. While RV pacing via a
traditional pacemaker restores heart function in these patients, recent studies
suggest that in patients with both AV block and LV dysfunction, sustained RV
pacing may escalate the progression of heart failure (HF).(1) More than 800,000
Americans have AV block, which occurs when the electrical signals are blocked
between the top and bottom chambers of the heart, reducing the organ's ability
to function normally.
"The BLOCK HF results should lead to a reassessment of the guidelines and the
way we treat these patients," said Anne Curtis, M.D., lead study investigator
and chair of the Department of Medicine at the University at Buffalo School of
Medicine and Biomedical Sciences, Buffalo, NY. "As a result of this trial, we
now know that heart failure hospitalizations and mortality may be reduced for
patients with AV block and heart failure if they receive biventricular pacing."
Heart failure is a major heath issue impacting the U.S. population, with nearly
6 million Americans currently diagnosed and approximately 670,000 new cases
confirmed each year.(2 )This debilitating and often deadly disease has been
estimated to cost the United States between $26 billion and $56 billion per
year(2), which includes the costs of healthcare services, medications and lost
The CRT devices used in the BLOCK HF trial are not approved by the FDA for the
patient population studied at this time.
About BLOCK HF
BLOCK HF (Biventricular versus Right Ventricular Pacing in Patients with Left
Ventricular Dysfunction and Atrioventricular Block) is a prospective, multi-
center, randomized, double-blind, controlled trial that evaluated patients with
AV block and LV dysfunction (ejection fraction less than or equal to 50
percent), New York Heart Association (NYHA) Class I, II or III and who met
standard indications for ventricular pacing. It enrolled 918 patients from 60
centers in the United States and Canada; of these, 691 patients were randomized
to receive either BiV (349) or RV (342) pacing. NYHA class at enrollment
consisted of 16 percent Class I, 57 percent Class II and 27 percent Class III.
Patients were followed for up to 102 months, with a mean follow-up of
approximately 36 months.
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 worldwide.
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.
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
(1 )Kindermann M, et al. Biventricular Versus Conventional Right Ventricular
Stimulation for Patients With Standard Pacing Indication and Left Ventricular
Dysfunction: The Homburg Biventricular Pacing Evaluation (HOBIPACE). J Am Coll
Cardiol. 2006;47(10):1927-1937. Available at
(2) American Heart Association. Heart Disease and Stroke Statistics - 2012
Update. Circulation. Available at
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Source: Medtronic, Inc. via Thomson Reuters ONE