NEWS
RELEASE
FOR IMMEDIATE RELEASE
Contact: Bobbie Boyd, Director of Public Relations
& Community Outreach
Advanced Cardiac Specialists
Cell Phone: (602) 570-7069 E-mail:
bobbie.boyd@acs-im.com
FDA-APPROVED DEVICE TO CLOSE HOLE IN THE
HEART
Reduced
Likelihood of Stroke with Closure Versus
Anti-blood
Clotting Therapy
Phoenix (September 17, 2005) - Findings released at the recent European Society of Cardiology meeting held in Stockholm, Sweden September, 2005 indicate patients who have experienced a “mini stroke” are less likely to suffer from a full stroke when the hole in the heart (PFO) is mechanically closed versus applying anticoagulation treatment therapy.
Patent foramen ovale (PFO) is, by far, the most common birth defect involving the heart that is seen in the normal adult population. It is estimated that 10-15% of adults have PFO.
While
in the mother’s womb, the fetus receives oxygenated blood from its mother. Because the fetus’ lungs are not expanded
and not involved in the process of oxygenation, it does not need as much blood
flowing through its lungs. So the blood
can be used more efficiently, it "takes a shortcut" through a small
hole (communication) between the left and right upper chambers of the heart
(atria), bypassing the lungs. This
communication is called the foramen ovale.
The foramen ovale normally closes at
birth and is sealed within the first year of life. In some people, the foramen fails to close. “Pure” (left heart) and
“impure” (right heart) blood
remain in communication and blood can “shunt” in either direction. This condition is called Patent Foramen
Ovale (PFO). The PFO represents a
potential path for blood clot from the venous circulation, usually the legs
(right heart) to access the systemic circulation (left heart), including the
cerebral circulation. Therefore, PFO
may be a potential risk factor for recurrent strokes or “mini” strokes.
Cerebral strokes occur in approximately
700,000 patients per year in the US.
The cause of stroke remains undefined (“cryptogenic”) in approximately
40% of them. Transesophageal
echocardiography (a semi-invasive cardiac ultrasound procedure) has
demonstrated an extremely high incidence of PFOs in patients with cryptogenic
stroke (56% versus 10% in the general population, in one study). More than 30 million Americans have PFOs
and 1 in 1,000 will have a stroke, with recurrent strokes in 3-11%.
Until recently, the only definitive
treatment for PFOs was closure of the defect by open-heart surgery. However, due to the risks and expense of
surgery, patients are usually treated with “blood thinners”. The safety and efficacy of blood thinners,
like warfarin, in the prevention of recurrent strokes is unpredictable at
best. Now there is a nonsurgical alternative
for definitive PFO closure using a “percutaneous” closure device.
The Food and Drug
Administration (FDA) has approved a device that is used to close (occlude) PFOs
– a PFO Occluder Device. The device can
be inserted through a small tube (catheter) inserted in the patient's arm or
leg vein. The doctor navigates it
through some of the patient's largest veins until it reaches their heart. The device is then placed at the site of the
PFO and closes it. The procedure takes
about an hour. The procedure is less
invasive than open-heart surgery.
Patients are usually discharged after an overnight stay in the hospital.
The
procedure is performed at select centers in the country, under a Humanitarian
Device Exemption approved by the FDA.
Robert M. Siegel, M.D., Medical Director of Advanced Cardiac Specialists
is among the select Interventional Cardiologists in the state who are certified
to implant PFO Occluder devices. Dr.
Siegel has performed this procedure successfully in a series of patients,
making Advanced Cardiac Specialists a leader in this technology in the Phoenix,
Mesa, Casa Grande, Prescott, Goodyear, Payson, Apache Junction, Gilbert, and
Gold Canyon areas. The procedures are
performed at Mesa General Hospital in the East Valley and at the Phoenix St.
Luke’s Medical Center in downtown Phoenix.
Additional information is available by calling (480) 926-6990.