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Senior Citizen Health & Medicine
New Expensive Treatment for Atrial Fibrillation May
Pay Off for Many
Left Atrial Catheter Ablation (LACA) getting attention as new option
June 20, 2006 - A new procedure that stops the most
common form of irregular heartbeat is expensive, but it may pay off in
the long run for many patients, new research suggests. That means it’s
important for doctors to choose carefully who receives it, and to
perform further research on its long-term benefit, the authors say.
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Being Tall Joins Being Old as Risk Factor for Atrial
Fibrillation
Study
is first to show height as a potent risk of this heart problem
April 14, 2006 – Most senior citizens are aware
that the risk of atrial fibrillation increases with age but now there is
a new risk and it cannot be controlled either – being tall. A new
analysis of data from a registry of patients with left ventricular
dysfunction indicates that height is an independent risk factor for an
arrhythmia of the upper chambers of the heart, according to a new study
in the April 18, 2006, issue of the Journal of the American College of
Cardiology. Read
more...
Read more
on
Health & Medicine |
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The study looks at a treatment called left atrial
catheter ablation or LACA, which in the last few years has attracted
tremendous attention as a new option for the 2.3 million Americans who
have a heart-rhythm condition called atrial fibrillation.
LACA delivers tiny “zaps” of radiofrequency energy
directly to the heart muscle to stop the electrical circuits that cause
irregular heartbeats. The treatment is seen as an exciting option for
atrial fibrillation, which interferes with daily life and greatly
increases the risk of stroke. But like any new therapy, LACA carries
costs and risks as well as benefits — and until now, no one has assessed
the economics of this treatment, or compared its costs and benefits with
those of drug-based treatment.
The new research, published in the Journal of the
American College of Cardiology by a team from the University of Michigan
Cardiovascular Center and the VA Ann Arbor Healthcare System, takes a
hard look at the dollars and cents of the issue.
Using sophisticated computer modeling, the
researchers tallied the cost and benefits of LACA and drugs for people
of different ages and health statuses. They ran calculations based on a
range of assumptions about LACA’s ability to reduce stroke risk, since
the procedure is still new enough that its stroke-preventing power isn’t
clear.
In general, the researchers found, it’s far more
cost-effective to provide LACA to atrial fibrillation patients who are
relatively younger (around 55 years of age), and who have one or more
risk factors for stroke besides atrial fibrillation, compared with
keeping them on traditional drug therapy to control heart rate. The
advantage isn’t so clear in older patients, nor in those who don’t have
other risk factors such as high blood pressure, diabetes, heart failure
or prior strokes.
“Before LACA is more generally adopted as a
treatment option, it’s important to ask from a societal perspective if
it’s cost effective, and under what conditions,” says first author Paul
Chan, M.D., M.Sc., a fellow in cardiovascular medicine at the U-M
Medical School and member of the VA Health Services Research &
Development Center. “This analysis provides a conservative model that
could be used to assess LACA’s cost-effectiveness as more is learned
about the impact of LACA on stroke risk.”
Adds senior author and cardiovascular medicine
associate professor Hakan Oral, M.D., who is a member of a U-M team that
has performed LACA on more than 2,000 atrial fibrillation patients and
published extensive research on the procedure, “Through rigorous
modeling with conservative estimates, this study provides the groundwork
for the cost-effectiveness of catheter ablation in treatment of atrial
fibrillation.”
He continues, “It appears that the longevity of the
patient population and the ability of catheter ablation to maintain
sinus rhythm and prevent future complications — primarily stroke — will
be the key factors in determining cost-effectiveness of catheter
ablation. However, besides cost issues, the value of improvement in the
quality of life of individual patients should also be carefully
considered.”
Chan, Oral and their colleagues performed the study
using a computer model that took into account life expectancy at age 55
or 65, the cost of the LACA procedure, the annual cost of drugs to
control heart rate or heart rhythm for the rest of a patient’s life, the
potential cost of LACA complications, the potential cost of caring for a
patient who had a stroke or cerebral hemorrhage, and knowledge from
previous research about the stroke risk faced by atrial fibrillation
patients based on age and health.
They also factored in results from research on the
efficacy of rate-control and rhythm-control drugs, using atenolol and
digoxin for rate control and amiodarone for rhythm control. They assumed
that all patients would take blood-thinning drugs (aspirin or warfarin)
to reduce the risk that blood clots would form and cause a stroke, and
included the cost of monitoring for patients on warfarin or digoxin.
Most of the assumptions made in building the model,
and the parameters for the different variables, were conservative,
meaning they were set to give drug therapy a cost-effectiveness
advantage over LACA. The model assumed that 80 percent of patients who
had the LACA procedure would experience a complete return to normal
heart rhythm after the first year, taking into account that some of
these patients may need to receive repeat procedures in that time. The
model also accounted for the fact that patients who were initially cured
with LACA may re-develop atrial fibrillation over time. The researchers
ran the computer simulation ten thousand times to more precisely define
how much stroke-risk reduction LACA would have to provide in order to be
cost-effective compared with drugs.
In the end, LACA’s cost-effectiveness prevailed
over either kind of drug therapy — and rate-control drug therapy was
more cost-effective than rhythm control by drug therapy in all cases.
In patients who had no other stroke risk factors
besides atrial fibrillation, the model showed LACA would not be cost
effective, costing an extra $98,900 per quality-adjusted life year
(QALY), or year of life adjusted for quality of life during that year.
The standard threshold for considering a therapy cost-effective is
$50,000 per QALY. In 55-year-old patients with one or two risk factors
besides atrial fibrillation, LACA’s added cost per QALY was $28,700,
meaning it would be cost-effective. In 65-year-old patients with one or
two more risk factors, the figure was $51,800 — not quite
cost-effective.
Since the stroke-preventing power of LACA isn’t
known, the researchers calculated what percentage risk reduction LACA
would have to achieve in order to make it a cost-effective option for
patients in different situations. For example, if LACA has an initial
“cure” rate of 80 percent for patients with atrial fibrillation, it
would have to result in a 42 percent reduction in annual stroke risk to
be cost-effective for 65-year-olds with a moderate stroke risk — but
only an 11 percent reduction in stroke risk for 55-year-olds. “This
means that LACA doesn’t have to have as big an impact on stroke risk to
be cost-effective for younger patients, because the benefits appreciate
over their lifetime,” says Chan.
The researchers also repeated their analysis using
less conservative assumptions that were not biased in favor of medical
therapy. For example, when they assumed that rate-control drugs would
restore only 20 percent of patients to regular rhythm at first, rather
than 38 percent, LACA didn’t need to achieve as powerful a
stroke-reducing effect in order to be more cost-effective than drugs.
(Recent research has suggested that rate-control drugs only help about
10 to 20 percent of patients return to regular rhythm.) Similarly, when
they changed the assumption about how much rate-control drugs would cost
per year, from $400 to $800, LACA was more likely to be cost-effective.
In the end, says Chan, more research is needed on
LACA’s long-term effect on stroke risk, quality of life and maintenance
of normal heart rhythm. But as more data emerge, he hopes the U-M/VA
model can be used to revisit LACA’s cost-effectiveness and guide
decisions about reimbursement.
In addition to Chan and Oral, the study’s authors
include VA/U-M assistant professor Sandeep Vijan, M.D., M.Sc., and Fred
Morady, M.D., the McKay Professor of Cardiovascular Diseases and
director of the U-M Clinical Electrophysiology Laboratory.
Dr. Chan is supported by an NIH Cardiovascular
Multidisciplinary Research Training Grant and by the Ruth L. Kirchstein
Research Service Award. Oral and Morady are founders and stockholders of
Ablation Frontiers, Inc, and have consulted to Biosense-Webster and
Ablation Frontiers. There was no grant or financial support from any
party and no party had any involvement in the design, collection,
management, or analysis of the study or in manuscript preparation.
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