A novel kind of pacemaker can substantially
boost the pumping power of victims of congestive heart failure,
offering an entirely new way of treating perhaps 1 million
Americans with bad hearts.
Doctors tested the device on people with especially
severe heart failure, all of whom were already receiving standard
heart medicines. Two-thirds improved significantly.
"The data are clear and impressive, but
what impresses me most is the experiences of individual patients,
who have improved to a degree we never would have expected,"
said Dr. William Abraham of the University of Kentucky, who
presented the results Tuesday at a medical conference in Orlando.
Earlier research has suggested that this approach,
called cardiac resynchronization therapy, can energize sluggish
hearts, but the new work is the first study to test it in
a rigorous, scientific way.
Heart failure is the only form of heart disease
that is actually on the increase in the United States. This
is because it is largely a disease of the elderly, and many
of those who once would have died of heart attacks now survive
long enough to have this disorder.
Heart failure is not, as its name implies,
the sudden failure of the heart to stop beating. Instead,
it is an inability of the heart to pump powerfully enough
to circulate the blood adequately. Symptoms include shortness
of breath, fatigue and fluid accumulation.
Between 2 million and 3 million Americans have
heart failure, and 400,000 new cases are diagnosed each year.
It causes 39,000 deaths annually and contributes to 225,000
more.
Pacemakers are widely used to speed up hearts
that beat too slowly. But using them to make weak hearts beat
more powerfully is a new development. At least three companies
are testing them in the United States.
In one-quarter to one-half of all heart failure
victims, the heart fails to beat in a uniform way. The walls
of their left and right ventricles _ the main pumping chambers
_ do not squeeze at precisely the same moment. This sloppy
motion robs the heart of its pumping power.
The new pacemakers deliver an electrical impulse
that synchronizes the ventricles so their walls pump in unison.
Abraham and colleagues tested a device called
InSync, developed by Medtronic Inc. of Minneapolis, which
paid for the study. Doctors implanted the quarter-size devices
in 266 patients. However, they left the devices switched off
in half of the patients and followed their progress for six
months.
Overall, 63 percent of the patients getting
working pacemakers improved substantially, as did 38 percent
in the comparison group. (At the end of the study, doctors
turned on those patients' pacemakers, too.)
Abraham estimated that between 750,000 and
1.25 million U.S. heart failure patients might be good candidates
for the devices. He said the devices are likely to cost $10,000
to $12,000 apiece, about the same as a high-end standard pacemaker.
Dr. Barry Massie of the University of California
at San Francisco said it is still unclear whether the devices
will help those with less severe heart failure or change the
long-term course of the disease.
Nevertheless, he said, "The results are
pretty exciting. It can only add to what drugs do. The two
together could be remarkable."
Most of the patients studied were taking diuretics,
ACE inhibitors and beta blockers, the standard medicines.
Doctors classify heart failure on a scale of 1 to 4, and all
of the patients were in the worst two categories.
After six months on the pacemaker, two-thirds
of the patients had improved by at least one category. They
also scored substantially higher on a scale that measured
quality of life, and they were able to walk an average of
128 feet farther in six minutes.
The first patient in the study was a former
World War II fighter pilot from the Cincinnati area. His heart
was so weak that he had been given six months to live when
he received his pacemaker in 1998. Now, at age 82, he can
climb stairs, walk several blocks without getting winded and
recently took a trip to New York City to see Broadway shows.