The CardioSEAL Septal Occlusion System is
authorized by Federal (USA) law as a Humanitarian Use Device for use
in the following indication:
The CardioSEAL Septal Occlusion System
is indicated for the closure of a patent foramen ovale (PFO) in patients
with recurrent cryptogenic stroke due to presumed paradoxical embolism
through a patent foramen ovale and who have failed conventional drug
therapy.
Cryptogenic stroke is defined as a stroke
occurring in the absence of potential known cardiac, pulmonary, vascular
or neurological sources. Conventional drug therapy is defined as a
therapeutic dosage of oral anticoagulants.
Some patients have a small hole in their heart called
a Patent Foramen Ovale (PFO) which is suspected as being the pathway for a small
embolus to travel from the right atrium to the left atrium. This embolus can
result in a blockage of blood flow to an artery, resulting in a paradoxical
embolic event, such as a stroke. You may have had this event multiple times
despite taking blood thinners. An implant can be placed in the heart using a
catheter. This procedure is called Transcatheter Hole Closure. It is an alternative
to open heart surgery. Transcatheter Hole Closure is a procedure that avoids
the need for open heart surgery. As a less invasive procedure, it is believed
to present fewer risks since open heart surgery is avoided.
Transcatheter Hole Closure is performed in the Cardiac Catheterization Laboratory
by a Doctor. The Doctor will gain access to the heart by getting access to a
major vein in the groin or internal jugular vein.
This is done by a needle puncture. Various catheters
will be advanced from the groin or neck into the heart. A test involving moving
pictures of the heart, called an angiogram, will be taken to better visualize
the heart and the hole. The Doctor may use a special ultrasound device, called
TransEsophageal Echocardiography (TEE). This is another way to better see the
heart and the hole. The TEE involves putting a probe into the esophagus, the
tube between the mouth and stomach. These tests are used to determine which
size implant the physician will use to close the hole.
The appropriate size implant is attached and collapsed for placement into a
special catheter. The catheter is then advanced to the site of the hole. The
Doctor re-expands the implant so that part of it sits on each side of the hole.
In effect the hole is gently sandwiched between the two sides of the implant.
The implant is then released from the catheter. The catheter is removed and
the procedure completed.
CardioSEAL is made from two, small diameter wire frameworks. The framework has
a special fabric attached to it. The device looks like two little umbrellas
set edge to edge. Each umbrella framework has special springs. This allows the
umbrellas to spring towards the hole. This very slight tension, along with the
blood in the heart, holds the device in place. Over time, tissue grows into
the fabric and the implant becomes part of the heart.
The risks are similar to those associated with other heart catheterization procedures.
There are additional risks associated with the implant. Examples include:
· dislodgement: The implant might move from its
intended position and migrate to undesired locations. This may result in stroke
or death.
· incomplete sealing of the hole, with incomplete sealing of the hole
and continued risk of stroke
· abnormal heart rhythms: abnormal heart beating with fast or slow heart
rate possibly leading to cardiac arrest.
· bruising at the groin or arm: from the needle entry site. Self limited.
· changes in blood pressure: which would be treated by the physicians
taking care of you
· air embolus: an air bubble that may go in the blood stream and cause
a stroke or death
· hemolysis: breaking of red blood cells that may require you to have
transfusions.
· apnea: a temporary cessation of breathing that may necessitate putting
you on a breathing machine.
· headache/migraine
· infection including endocarditis which is an inflammation of the lining
of the heart valve that may result in damage to the valves, stroke, heart attack
and possible need for surgery
· perforation of vessel or myocardium: a tear in a blood vessel or the
heart that may result in fluid build up aroung the heart necessitating sticking
a needle to remove that fluid or open heart surgery.
· thromboembolus: a blood clot within a blood vessel that may go to the
lungs and cause death or cardiac arrest and that may necessitate taking a blood
thinner for a long time (6 months)
· stroke or TIA: a stroke may result from decreased blood flow to the
brain and a TIA (transient ischemic attack) may result from transient lack of
oxygen to the brain with resultant transient neurological symptoms
· valvular regurgitation: leaking of the heart valve that in extreme
situation may necessitate heart surgery.
· fracture of the implanted device: with unkown consequences, however,
it may stop perfoming its function and may necessitate removal using open heart
surgery
· palpitations: symptoms of rapid or slow heart beats or skipped heart
beats, which may reflect serious heart damage
What is the special care after the procedure?
· bed rest for a period of time (this allows the implant to firmly stabilize)
· restriction from heavy lifting or other physical activities for a period
of time
· take a blood thinning product, such as Aspirin, every day, for a period
of time (perhaps six months or longer)
· take antibiotics to prevent infection for a period of time (perhaps
six months or longer and when going to the dentist or having a minor surgical)
· follow the doctor's instructions precisely
· call the doctor if there are any questions
The same procedure can be used to occlude a ventricular
septal defect
