FOR RELEASE: 4 p.m., ET, Monday January 26, 1998
NR 98-4853 (Circ/Farhat)*

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American Heart Association journal report:

Balloon procedure shown to improve quality of life in people with narrowed
mitral heart valves

DALLAS, Jan. 27 -- A relatively non-invasive surgical procedure, similar to
balloon angioplasty, can dramatically improve the quality of life for
patients who suffer from narrowed heart valves resulting from rheumatic
heart disease.

In today's Circulation: A Journal of the American Heart Association,
researchers in Tunisia report that percutaneous balloon mitral
commissurotomy (BMC) -- which uses a balloon-tipped catheter to separate
the narrowed mitral valve leaflets -- not only was safer, but was also more
effective than comparable procedures. Commissurotomy is the term used for
the procedure which separates the narrowed leaflets.

When this condition, known as mitral stenosis, occurs, blood does not flow
completely from one chamber of the heart to another. This condition is
usually the result of an episode of rheumatic fever during childhood.
Rheumatic fever can damage the mitral valve in such a way that it begins to
form scar tissue. As this scar tissue grows, it affects the flexibility of
the valve and the edges actually begin to grow together. As this condition
progresses, less and less blood can pass through the valve.

As a result, blood that remains behind can clot. Blood clots can obstruct
blood vessels, setting the stage for heart attack and strokes. According to
the American Heart Association, many of the 71,000 annual operations on
valves are related to rheumatic heart disease.

The researchers' study involved a total of 90 patients, randomly assigned
to three groups, each with 30 individuals.

A total of 93 percent of those in their study who had BMC did not have to
undergo another procedure to widen the mitral valve in the seven-year
follow-up.

Another 30 patients in the study had open mitral commissurotomy (OMC) --
the traditional treatment used over the past 25 years -- and 90 percent of
them did not need another procedure.

In 30 other patients studied who had closed mitral commissurotomy (CMC) --
a procedure in which the surgeon uses a knife blade on the tip of his or
her finger to separate the narrowing -- half needed another procedure. CMC
is the oldest form of commissurotomy.

OMC involves opening the chest cavity to perform the procedure. In closed
commissurotomy, the surgeon operates by "feel."

"The most striking and unsuspected finding at the beginning of the study
was the excellent long-term results obtained after the balloon procedure
that were, like those of the chest-opening operation, far superior to those
after CMC," says lead author Mohamed Ben Farhat, M.D., of the Fattouma
Bourguiba University Hospital in Tunisia.

In an editorial in today's Circulation: A Journal of the American Heart
Association, Igor Palacios, M.D., an associate professor of medicine at
Harvard Medical School, says that the findings support the concept that
BMC, "should be the procedure of choice for the treatment of patients with
rheumatic mitral stenosis who are optimal candidates" for the procedure.

None of the patients died during the seven-year follow-up.

"Our excellent survival rate is undoubtedly due to the younger age of our
patients, almost all of whom were women and had favorable mitral valve
anatomy," says Ben Farhat.

Of the 90 patients ranging in age from 11 to 50 years old in the study, 77
were women. In the follow-up, it was found that the area within the mitral
valve increased in those patients who had BMC or OMC much more than in
those with CMC. The rate of restenosis - re-narrowing of the valve - was
only 6.6 percent after BMC or OMC compared to 37 percent after CMC.

According to the researchers, the lower-success rates shown in CMC are not
an indictment of the surgeons who perform the procedure. Rather, they
believe that technical problems in the closed techniques are to blame.

Co-authors are Mokdad Ayari, M.D.; Faouzi Maatouk, M.D.; Fethi Betbout,
M.D.; Habib Gamra, M.D.; Mourad Jarrar, M.D.; Mabrouk Tiss, M.D.; Sonia
Hammami, M.D.; Rafik Thaalbi, M.D.; and Faouzi Addad, M.D.

###

Media advisory: Dr. Mohamed Ben Farhat can be reached by phone 011 216 346
0 822 or by fax at 011 216 346 0 737. Dr. Palacios can be reached at (617)
726-8424. (Please do not publish telephone numbers.)

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