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New Studies Support Medicare Decision to Expand
Defibrillator Coverage - Implants Save Lives
 Nov.
9, 2004 – With Medicare poised to expand coverage for implanted cardiac
defibrillators, two new studies say these devices that can shock a
failing heart back into regular rhythm do an excellent job of keeping
patients alive.
The researchers found that those who received an
ICD were 60 percent less likely to die in the next year, and 48 percent
less likely to die in three years, than those who did not receive an ICD.
Most of this reduction in death risk was due to reduction in
heart-related deaths. ICDs are specifically designed to prevent sudden
cardiac death, in which the heart’s electrical system goes haywire,
causing it to stop beating.
But ICD recipients who had co-existing medical
conditions, especially diabetes or kidney failure, were much more likely
to die within a year of getting the device than other patients. So were
patients who received an ICD, but didn’t get heart-protecting
medications that are part of standard heart-failure therapy.
It’s the first “real world” study of the effect of
ICDs on mortality rates among heart failure patients with ischemic heart
disease treated outside of clinical trials, says lead researcher and U-M
cardiology fellow Paul Chan, M.D.
The research at the University of Michigan also
suggests that doctors may be able to categorize their patients according
to their individual risk factors, to determine who might get the largest
benefit from the expensive devices, called implanted cardiac
defibrillators, or ICDs. The studies also reinforce the importance of
providing good follow-up care to all heart failure patients, whether or
not they receive an implanted device.
With Medicare covering ICDs for many more patients
than ever before, the new results may help doctors decide which patients
might get the greatest benefit from the costly devices. More than half a
million more people may qualify for ICDs, which cost around $20,000,
under Medicare guidelines that will take effect soon.
The data were presented today in two talks at the
Scientific Sessions of the American Heart Association by a U-M
Cardiovascular Center team that analyzed data from 7,000 veterans
treated for heart trouble in Veterans Affairs hospitals between 1995 and
1999. All had congestive heart failure, heart muscle damage caused by
clogged blood vessels, and a heart rhythm irregularity called
ventricular arrhythmia. Of the 7,000 patients, 1,442 had received an
ICD.
“We need to make sure that as this technology is
disseminated out of the carefully controlled environment of clinical
trials and into the broader population, we assess whether the benefit
seen in those trials is sustained,” says Chan.
“And indeed, we see that those who received an ICD
had significantly less mortality,” he continues. “For every five people
with heart failure and ischemic heart disease who received an ICD, one
life was saved over three years. But those with certain pre-existing
conditions were more likely to die within a year, despite the benefits
of ICDs.”
In all, 20 percent of patients who didn’t receive
ICDs died of heart-related causes by the end of the first year after
their hospitalization, compared with 8 percent of those who received
ICDs. By the end of three years, 36 percent of patients who didn’t
receive ICDs died of heart-related causes, as compared with 23 percent
of those who did. Death rates due to non-heart causes were similar
between the two groups.
Chan and his mentor, U-M internal medicine
professor and VA Ann Arbor Healthcare System researcher Rodney Hayward,
note that the finding of major differences in mortality benefit among
different patient groups should help doctors decide which patients are
less likely to die within a year of ICD implantation, and how to manage
them after they’ve received the device.
The veterans in the study who received ICDs were
classified into four groups, depending on the number of points they
scored on a measurement of how many co-existing conditions they had and
how many heart medicines they were on. The higher the score, the higher
the patient’s risk.
The researchers found that 28 percent of those in
the highest-scoring group died before the end of one year, as compared
with only 2.2 percent of those in the lowest-scoring group.
Part of this difference was due to pre-existing
diabetes, kidney failure, high blood pressure and clogged blood vessels
in other parts of the body. For example, the rate of diabetes among ICD
patients who died before a year was 42 percent, compared with 31 percent
who among those who survived. Similarly, kidney failure was more common
among the ICD group that died before the one-year anniversary of their
implantation than among those who lived — 17 percent compared with 5.7
percent.
Moreover, failure to control some of those
pre-existing conditions, such as high blood pressure, with medications
such as beta blockers, ACE inhibitors and angiotensin II receptor
blockers was associated with a higher likelihood of death within a year
of ICD implantation.
“Physicians need to realize that once they implant
an ICD, they can’t relax — the patient isn’t home free,” says Chan. “We
need to ensure that patients receive established cardio-protective
medications that can add to the benefit delivered by the ICD.”
But, he adds, in heart failure patients who don’t
have serious co-existing conditions and who are able and willing to keep
up with their drug regimens, “There’s no excuse for not putting in an
ICD. We already know it’s cost-effective, and now we can see from
real-world evidence that it provides a true reduction in mortality.”
In addition to Chan and Hayward, who directs the VA
Health Sciences Research & Development Center at the Ann Arbor VA
Healthcare System, the research team included data analyst Jenny Davis
and Mark Starling, M.D., who directs the Ann Arbor VA cardiology
division and the U-M cardiology fellowship program.
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