MeSH
| patent arterial duct |
transcatheter closure |
Amplatzer duct occluder |
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Abstract
Following its introduction into clinical practice, the Amplatzer duct
occluder (ADO) has achieved a definite place in the armamentarium of the
interventional cardiologist for the closure of moderate to large sized
PDAs. The device combines ease of use, including retrievability and repositioning
when required, and a high occlusion rate (>99% complete occlusion of PDA
within 6 months of implant, with the majority of occlusions occurring within
24 hours of implant). Possible complications, such as device embolization,
protrusion of the retention disc of the device into the aorta producing
aortic obstruction, or obstruction of a branch pulmonary artery by the
device are also uncommon and can be avoided by choosing the appropriate
sized device (with the pulmonary end of the device being 2mm larger in
diameter than the minimum measured ductal diameter), and paying scrupulous
attention to technique of deployment. The device can be safely deployed
in infants >3.5 kg, and can currently close PDAs of upto 11 to 12mm in
minimum diameter. A brief description of the device, the technique of implantation,
and the clinical results to date are provided.
Introduction
A number of devices are currently available for percutaneous closure
of the patent ductus arteriosus (PDA). For the smaller ducts, the Gianturco
coil and its modifications, including the detachable release coil, have
proven to be efficacious, utilising delivery systems of 4F or 5F diameter,
and allowing implantation from either the arterial or venous approach.1
For ducts with minimum diameters exceeding 3mm however, coil implantation
is associated with higher procedural complexity such as the use of multiple
coils usually via a combined arterial and venous approach to allow simultaneous
deployment with intertwining of coils, and a higher rate of embolization
and residual shunting. The Amplatzer duct occluder (ADO) has proven to
be an elegant device that allows moderate and larger sized ducts (upto
11 mm in minimum diameter) to be successfully occluded by the percutaneous
approach. It combines ease of implantation with a high occlusion rate and
a low rate of procedure – related complications.2-6 The procedure
can be safely carried out in infants >3.5 kg in weight with symptomatic
PDA.
Device description
The Amplatzer Duct Occluder (AGA Medical Corporation, Golden Valley,
MN) is a self-expanding and self-centering device, made from 0.0004 to
0.0005 inch Nitinol wire mesh. It is mushroom-shaped with a low profile
and consists of a flat retention disk and a cylindrical main body, into
which polyester fibers are sewn. Platinium marker bands are laserwelded
to each end and a steel sleeve with a female thread is welded into the
marker band (figure 1). The retention disk is 4 mm larger than the main
body, which itself has a conical structure. The delivery system consists
of a delivery cable, a Mullins-type sheath, loader and a pin vise. The
device comes in different sizes, requiring sheath sizes from 5 to 7 F for
delivery. These details are available from the accompanying graphic charts
supplied by the manufacturer. The size of device chosen is generally such
that the diameter of the pulmonary end of the device is at least 2 mm larger
than the narrowest diameter of the duct. Device sizes are categorised according
to the diameters of the aortic and pulmonary ends of the device. The standard
device sizes are 6/4, 8/6, 10/8, 12/10, 14/12 and 16/14 mm respectively,
where the first number refers to diameter of the the aortic end and the
second number to the pulmonary end of the conical shaped device. The devices
are all 7mm long. The device can be delivered through sheath sizes ranging
from 5F (for devices upto 8/6) to 7F (for all larger devices).
Figure 1: Left - the Amplatzer duct occluder as seen when removed
from its packaging. The device has a tapering conical shape, with the pulmonary
end at the bottom of the picture. The female end of the screw-system for
attachment of the device to the delivery cable is also seen at this end.
At the top of the picture (at the aortic end of the device), the flared
aortic retention disc is seen. Centre - the ADO viewed side-on, as held
between the operator´s fingers. Right - the pulmonary end of the
device is shown, with the screw welded screw-system for device attachment
to the delivery cable.
Implantation technique
The procedure can be performed under conscious sedation in older patients,
or using general anesthesia. A single dose of intravenous antibiotic is
administered (usually a cephalosporin), as is standard practice for all
interventional implantation procedures. The femoral vein and artery are
canulated percutaneously. The size and configuration of the duct are determined
by descending aortic angiography, using a 4F or 5F pigtail catheter (figure
2).
Figure 2: Descending aortogram demonstrating the shape, length
and course of the duct (arrow). AO=aorta; PA=pulmonary trunk.
The arterial catheter is then withdrawn to the femoral
artery to avoid interference with ADO deployment. The minimum diameter,
the diameter of the aortic ampulla and the length of the duct are measured.
An endhole catheter (usually 5F) is passed through the duct from the pulmonary
side into the descending aorta, if necessary with the help of an 0.035"guidewire
(figure 3).
Figure 3: An end-hole 5F multipurpose catheter
has been advanced anterogradely from the femoral vein and through the duct
into the descending aorta.
The endhole catheter is then exchanged for a delivery
sheath, over an 0.035" exchange length (260 cm long for older patients)
guidewire (figure 4).
Figure 4: The endhole catheter has been exchanged
for a 6F delivery sheath, with the tip of the sheath in the descending
aorta.
The appropriate ADO device is chosen, such that
the diameter of the pulmonary end is at least 2 mm larger than the narrowest
diameter of the duct, and immersed into saline solution. The delivery cable
is passed through the loader and the device is screwed on clockwise to
the tip (figure 5).
Figure 5: Top panel - the delivery cable
for the ADO has been passed through the loading sheath. Second panel -
after attachment of the ADO to the delivery cable, the cable is gently
withdrawn to allow the device to pass into the loading sheath. Third panel
- the delivery cable is shown within the loading sheath, with the ADO attached
to its distal end. Bottom panel - The delivery cable has been pulled back
so that the ADO is at the tip of the loading device. Further pullback compresses
the device and allows it to enter the loading sheath.
Thereafter, the whole system is immersed into saline
again (figure 6). The device is now pulled into the loader and the loader
is introduced into the delivery sheath.
Figure 6: Top - the ADO is completely within
the loading sheath, and the entire system is flushed with saline to remove
any air bubbles. Bottom - the hub of the loading sheath (with the device
contained within it) has been advanced through the haemostatic valve at
the proximal end of the delivery catheter. The ADO can now be advanced
into the delivery sheath by pushing the delivery cable distally.
The device is advanced through the delivery sheath
into the descending aorta (figure 7).
Figure 7: The fluoroscopic image demonstrates
the ADO within the delivery sheath, still attached to the delivery cable,
at the level of the pulmonary trunk.
The retention disk is deployed in the descending
aorta, by gently withdrawing the delivery sheath (figure 8). The sheath
and the retention disk are pulled back as a single unit, firmly into the
ampulla of the duct. The rest of the device is then uncovered within the
duct, by holding the delivery cable of the ADO stationary while pulling
back the delivery sheath.
Figure 8: Top - the retention disc of the
device has been extruded beyond the distal end of the delivery sheath,
in the descending aorta. Middle - the sheath and delivery cable are pulled
back as one unit, to allow the retention disc to engage the ampulla of
the duct. Bottom - further pullback of the delivery sheath allows the entire
occluder to be uncovered within the duct. At this point, descending aortography
may be performed to confirm that the device is appropriately positioned.
If such is not the case, the device may be withdrawn into the delivery
sheath by pulling on the delivery cable, and the entire procedure repeated.
An aortogram is performed to confirm correct device
position, taking care in particular to ensure that the retention disc is
sitting entirely on the rim of the ductal ampulla, is not obstructing the
descending aorta, and has not partially prolapsed into the body of the
duct (figure 5). If the device needs to be repositioned or retrieved, it
can be pulled back into the sheath, and the entire procedure repeated,
either with the same device or using a different sized device as deemed
appropriate. If the position is correct, the device is released by rotating
the delivery cable in an anticlockwise direction (as indicated by the arrow
on the vise) with the pin vise (figure 9).
Figure 9: Real-time fluroscopy showing release
of the device. The device is released, and the delivery cable is within
the delivery sheath, at the level of the pulmonary valve.
Following successful detachment of the device the
delivery system is removed. A repeat aortogram may be done 5 to 15 minutes
after the release, to reconfirm device position (figure 10).
Figure 10: Post-release aortogram confirming
ideal device position. The retention disc is appropriately configured to
the ductal ampulla.
The arterial and venous catheters and sheaths may
thereafter be removed, and hemostasis achieved by manual compression of
the groin. At 24 hours post-procedure, an echocardiogram (cross sectional,
spectral and colour flow Doppler studies are performed to demonstrate the
orientation of the device, its relation to the descending aorta and the
branch pulmonary arteries, and to document the presence and degree of residual
shunting) and a chest x ray in the posteroanterior and lateral projections
are obtained, prior to discharging the patient from hospital. Further clinical
follow-up and echocardiography are undertaken at 6 weeks, 3 months, 6 mnoths
and 12 months post-ADO implantation.
Discussion
Follow-up studies following ADO deployment have
confirmed occlusion rates of >99% within 6 months of device deployment,
with minimal complication rates.2-6 The majority of occlusions
can be confirmed within 24 hours, prior to discharge from hospital. Protrusion
of the retention disc into the descending aorta, producing aortic obstruction
is a rare complication, and may necessitate removal of the device.7
To avoid this potential complication, aortography is always recommended
after device deployment, prior to release, and following release of the
device. Even after the device has been released, it can be retrieved if
necessary by transcatheter techniques, and the duct occluded using a new
device. A modification of the ADO has been described to avoid this complication,
in which the aortic retention disc is angulated at approximately 32o
to the body of the device and is concave towards the aorta, and may
be indicated in special instances.8 Device protrusion into the
left pulmonary artery is also infrequently seen when compared with the
Rashkind device or following the use of multiple coils,9,10
as the device has a low profile on the pulmonary side. Late device embolization
into the pulmonary arteries, occurring at upto 24 hours following implant,
was reported in the early series, and was probably due to the use of a
smaller than optimal device.4 This may be avoided by confirming
that no part of the retention disc has prolapsed into the body of the duct,
prior to release.
There has to date been a single procedure-related
death with use of the ADO.11 In that patient the device, which
was probably too small for the duct in question, embolized into the descending
aorta and was not retrieved until 4 hours later, resulting in mesenteric
vascular complications and sepsis. Device embolization into the aorta would
constitute a medical emergency, necessitating immediate transcatheter or
surgical retrieval of the embolized device.
In conclusion, the implantation and clinical follow-up
data available to date confirm that moderate to large PDAs can be safely
occluded using the ADO in patients from 3.5 kg in weight upwards, with
excellent occlusion rates and minimal complications.
References
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Contact information
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N. Sreeram
Department Pediatric Cardiology,
University Hospital of Cologne,
Kerpenerstrasse 62
50937 Cologne, Germany
Phone: 0049 221 478 86301
Fax: 0049 221 478 86302
N.Sreeram@uni-koeln.de
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