Study
to determine if heart angioplasty is safe in community hospitals
Newswise — Cardiologists at Johns
Hopkins have launched a nationwide study of more than 16,000
patients to see if a potentially life-saving procedure called
angioplasty can be safely performed in smaller, community hospitals,
easing access to the therapy for patients. Researchers expect to
enroll the first study patients in early fall 2005.
Angioplasty is a procedure in
which a tiny balloon is inflated and used to widen a blocked artery
narrowed from the buildup of cholesterol-laden plaque. Most states’
health care regulations limit the availability of angioplasty in
community hospitals to emergency situations, such as during a heart
attack. In all other cases, patients must be transferred to another
hospital that has on-site, specialized heart surgery backup.
This kind of surgical backup has
been required for nonemergency angioplasty because, in rare
instances, the procedure has led to a tear in a vessel or closing of
an artery rather than opening it. The risk that angioplasty patients
will need emergency heart bypass surgery is less than 1 to 2 in
every 1,000 cases. Indeed, medical advances in the last two decades
have provided nonsurgical means of treating many of these
complications, including the use of stents to keep arteries open.
For these reasons, the researchers say, the need for on-site cardiac
surgery backup is questionable. However, they point out, national
guidelines from the American Heart Association and the American
College of Cardiology have for the past 20 years maintained a
requirement for on-site cardiac surgery to back up angioplasty.
“There is a large and growing
number of people who could benefit from angioplasty, and the
procedure is being applied to more types of heart conditions,” says
interventional cardiologist and study senior investigator Thomas
Aversano, M.D., an associate professor at The Johns Hopkins
University School of Medicine and its Heart Institute.
“Many patients with coronary
artery disease admitted to hospitals that do not have angioplasty
available would benefit from transfer to a hospital where they can
have angioplasty performed.
“The ability to perform
angioplasty at hospitals without on-site cardiac surgery will
significantly improve access and outcomes for the more than one-half
of patients who would benefit from such a transfer but in fact are
not transferred and consequently have a higher mortality,” Aversano
says.
According to the American Heart
Association, in 2002 an estimated 650,000 angioplasty procedures
were performed on 640,000 Americans. This amounts to a 324 percent
increase in volume since 1987.
In the Hopkins-led study,
conducted by the Cardiovascular Patient Outcomes Research Team, or
C-PORT, participating patients who require angioplasty will be
randomly assigned to have angioplasty at either the community
hospital without on-site cardiac surgery where they underwent
diagnostic catheterization or at a center with on-site cardiac
surgery for angioplasty, which is the usual treatment. Each
participant’s progress will be followed by the researchers for a
period of six months to determine their health status and whether
they have any subsequent problems related to their heart. At the end
of the study, expected in 2008, the researchers will compare
outcomes, or well-being, of patients treated in the two groups.
About 40 community hospitals are
expected to participate in the study. Special waivers from state
authorities are required for participating community hospitals.
So far, six states have confirmed
waivers for community hospitals to participate in the study: New
Jersey, Georgia, Illinois, Ohio, Pennsylvania and Alabama. Several
other states are considering granting waivers.
In addition to the waiver from
their state government, participating community hospitals must also
have a combined emergency and elective angioplasty volume of at
least 200 cases per year and a staff whose training meets national
standards set by the American Heart Association and American College
of Cardiology.
Aversano has a long track record
of studying best practices in medicine. His previous research,
published in the Journal of the American Medical Association in
2002, showed that heart attack patients who received emergency
angioplasty at hospitals without cardiac surgery as backup did
better than patients initially treated with a clot-busting drug to
open up the artery.
“The aim of our study is to
determine what is best for the patient and what kind of hospitals
should provide angioplasty services and under what conditions,” says
Aversano. “The results will allow physicians and health policymakers
to develop evidenced-based policies about who will have access to
angioplasty services, and the results, we believe, will
significantly influence the overall quality of cardiovascular care
in community hospitals.”
Funding for the study is provided
by participating hospitals.
Additional statistics from the AHA
show that 66 percent of angioplasties are performed on men and half
are performed on people age 65 and older. According to reimbursement
schedules available from Medicare, the federal program that funds
health care for the elderly, the cost of angioplasties ranges from
$11,000 to $18,000.
Study
to determine if heart angioplasty is safe in community hospitals