In this section
You have already been informed that your child has an Atrial
Septal Defect (ASD) which needs to be repaired. In the past the
only way of doing this involved open-heart surgery. This was a
major procedure that necessitated heart lung bypass and required
several days of hospitalisation. The operation involved a
thoracotomy with its attendant pain and subsequent need for wound
healing and left a permanent scar on the chest. In some cases blood
transfusion was needed and full recovery took a few weeks. Surgery,
at the present time, can be accomplished with minimal risk (less
than 1%), but because of the obvious discomfort and relatively long
recovery period, alternative procedures have been developed.
Over the last few years it has become possible to close ASDs
with a catheter technique, which avoids the need for surgery and
requires only a very brief period in hospital. We have carried out
more than two hundred procedures at the Royal Children's Hospital
with such devices and are now offering the option of using a new
device with different features and some important advantages. This
device is called the HELEX device. Your child has been selected as
a possible candidate for this procedure, because there is
considered to be a high likelihood of successful closure with this
The duration of the procedure will be about 1-2 hours. The
catheter will be introduced into a leg vein at the groin and X-ray
pictures (angiograms) performed to show the defect. An appropriate
sized device will be placed in the defect to achieve closure. An
Echo probe will be passed through the mouth and placed in the
oesophagus to visualise the heart during the procedure.
Once satisfactory positioning is confirmed the device would be
released. After recovery from anaesthesia and 2 hours of bed rest,
your child will be able to sit up and walk about. There may be no
need to stay in the hospital overnight (many patients can go home
on the day of the procedure) but on the following day we will need
to repeat an x-ray of the chest and echocardiography to confirm the
position of the device. Some bruising and soreness may persist, in
the region where the catheter was introduced, for approximately one
week. The procedure can be performed under a local anaesthetic, but
in small children (and some older patients), the procedure will
usually be performed under general anaesthesia.
The clinical study requires a follow-up examination at 24 hours,
1 month, 6 months and 1 year. This entails a physical exam,
Echocardiography and X-ray of the chest on all visits to ascertain
satisfactory closure. During the exam at 6 months your child will
also undergo a detailed X-ray (Fluoroscopy) examination of the
device, which would be undertaken in the catheter laboratory
but only takes approximately 15 minutes.
The primary advantage of this procedure is that it is a
non-surgical technique and is an alternative to open heart surgery.
The pain of surgery is avoided and, in comparison to several days
hospitalisation for surgery, your child will probably be in the
hospital for only 1 day. The procedure requires no blood
transfusions, and a scar on the chest will be avoided.
The risks of the procedure are very low and similar to those of
routine cardiac catheterisation. These include allergy to
X-ray dye, accidental introduction of air or blood clot (embolism)
with potential for "stroke", bleeding around introducer sheaths,
disturbance to the heart rhythm during the procedure, infection,
injury to the artery, vein or nerves in the groin, and perforation
of the heart. Each of these problems is very rare and is not likely
to be different than with many other heart catheter procedures.
Moreover similar problems can occur during open-heart surgery.
Probably the main risk, specific to this procedure, is that the
device may dislodge and
not satisfactorily close the defect. If this were to happen an
attempt would be made to retrieve the device, by a catheter
technique, and a further device could then be positioned, if
considered appropriate. If the device cannot be retrieved easily
from the heart, your child will need cardiac surgery for its
removal and at the same time the ASD would be repaired. It is
anticipated that the risks of the procedure would be no greater
than with open-heart surgery.
The fabric used in the device is similar to that used by
surgeons to repair some heart defects. The wire frame is made
of a biocompatible alloy (Nitinol), which has been employed in
different kinds of surgical 'implants' over many years. Structural
failure of the device has not been encountered in experimental
studies. It is not likely to lead to any adverse effect.
Compared with other devices the HELEX device is less 'bulky' and
contains only a very small amount of metal (Nitinol) that is
covered by the fabric material and not in contact with the blood.
It is expected that the device will rapidly become covered by
natural tissue and will 'heal' into the heart very completely.
During the procedure to place the device it is easily retrievable
if its position is not satisfactory and even after it has been
'locked' into position it can still be removed with the catheter if
it is not satisfactorily closing the defect or is thought to be
unsatisfactory for any reason. If this were to be necessary it
might be possible to introduce a different / larger device to close
the defect, thus avoiding the need for an operation.
If, at any time, you have any questions, concerns, or wish to
discuss this further please contact Dr Geoff Lane
on (03) 9345 5712