The use of self-administered blood
thinners in patients undergoing treatment for atrial fibrillation is as
safe as administering anticoagulants intravenously and may result in better
outcomes, including shorter hospital stays and improved heart rhythm five
weeks after treatment. These are the findings of a Cleveland Clinic-led
study that will be published in the Nov. 28th issue of the European Heart
Journal.
The Assessment of Cardioversion Using Transesophageal Echocardiography
(ACUTE II), a randomized, multicenter pilot study, compared the safety and
effectiveness of subcutaneous enoxaparin (a low molecular weight version of
the blood thinner heparin) with intravenous unfractionated heparin in 155
patients scheduled to receive transesophageal echocardiography (TEE)-guided
cardioversion for atrial fibrillation, a condition characterized by an
abnormal heart rhythm.
"Our study strongly suggests that use of enoxaparin may be a safe and
effective alternative treatment in patients undergoing TEE-guided
cardioversion for atrial fibrillation," said the study's lead author, Allan
Klein, M.D., a cardiologist and Director of Cardiovascular Imaging Research
at Cleveland Clinic. "The ability to use enoxaparin could reduce the number
of patients who require hospitalization prior to cardioversion or reduce
the number of days in hospital, lowering health care costs and giving
physicians an alternative to intravenous heparin for lessening the risk of
clot development and stroke," he said.
TEE-guided cardioversion uses high-resolution ultrasound to verify if
patients with atrial fibrillation have blood clots in the heart that would
put them at risk of stroke during cardioversion, the application of
electrical shocks to restore normal heart rhythm. Cardioversion is known to
restore normal heart rhythm, decrease symptoms, as well as improve heart
function and a patient's quality of life; however, it has been associated
with an increased risk of stroke.
In the ACUTE II study, 76 patients were randomly assigned to receive
enoxaparin and 79 patients were randomly assigned to receive unfractionated
heparin prior to undergoing a TEE-guided cardioversion. Safety and efficacy
outcomes were measured in all patients five weeks after the procedure.
The researchers found that with the use of enoxaparin, which is self-
administered by patients subcutaneously and does not require any or
prolonged hospitalization, compared to the use of unfractionated heparin,
which is delivered intravenously and often requires a prolonged hospital
stay due to overlap with an oral anticoagulant (warfarin), there was no
difference in the incidence of stroke, bleeding or death between the two
groups. However, they did note shorter hospital stays and a more normal
heart rhythm five weeks after cardioversion among patients treated with
enoxaparin.
The ACUTE II study builds upon groundbreaking research that Dr. Klein
completed in 2001 which showed that TEE-guided cardioversion is a
clinically effective strategy for patients treated for atrial fibrillation.
That research appeared in the May 10, 2001 issue of the New England Journal
of Medicine.
Atrial fibrillation is a growing public health concern, affecting
approximately 2.3 million Americans. The condition is most commonly
diagnosed in the elderly and is characterized by an abnormal heart rhythm
that results in shortness of breath and fatigue. Atrial fibrillation and
can lead to congestive heart failure, stroke and death. It is projected
that nearly 5.6 million Americans will suffer from this condition by 2050.
Cleveland Clinic Heart & Vascular Institute is the recognized world
leader in the diagnosis and treatment of cardiovascular disease. Cleveland
Clinic has been ranked No. 1 in the nation for cardiac care by U.S. News &
World Report every year since 1995. It has also been ranked among America's
Ten Best Hospitals every year since 1990 by U.S. News & World Report.
Cleveland Clinic, located in Cleveland, Ohio, is a not-for-profit
multispecialty academic medical center that integrates clinical and
hospital care with research and education. Cleveland Clinic was founded in
1921 by four renowned physicians with a vision of providing outstanding
patient care based upon the principles of cooperation, compassion and
innovation. U.S. News & World Report consistently names the Cleveland
Clinic as one of the nation's best hospitals in its annual "America's Best
Hospitals" survey. Approximately 1,500 full-time salaried physicians at
Cleveland Clinic and Cleveland Clinic Florida represent more than 100
medical specialties and subspecialties. In 2005, there were 2.9 million
outpatient visits to the Cleveland Clinic. Patients came for treatment from
every state and from more than 80 countries. There were nearly 54,000
hospital admissions to the Cleveland Clinic in 2005. For more information,
visit clevelandclinic.
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