PDA Occlusion with the “Sideris” Devices
E.B.
Sideris, P.S. Rao, R. Zamora
Athenian
Institute of Pediatric Cardiology.
Athens,
Greece
Address
for Correspondence:
E.B.
Sideris MD,
Athenian
Institute of Pediatric Cardiology,
21
Rizariou st., Halandri, 152 33
Athens,
Greece
Tel:
01-6820834, Fax: 01-6852270, E-mail: terry@hol.gr
ABSTRACT
This is a review of the experience with the “Sideris”
devices for the occlusion of patent ductus arteriosus in the last
decade. The devices used were the regular buttoned device, the infant
buttoned device, the device with the folding plug and the wireless
devices.
The transvenous method was used. Buttoned devices were
introduced through
7-8F long sheaths for PDAs up to 12mm; wireless
devices required 9-11F sheaths for PDAs up to 22mm. All different
shapes of ductus were occluded. The records of 356 patients were
reviewed.
Despite excellent long term full occlusion rates and absence of
significant complications with the regular device, modifications were necessary to improve on the full occlusion rates in 24
hours. The 24 hour rates improved
from 60% with the regular device to 84% with the device with
incorporated folded plug . Most residual shunts disappeared on long
term without significant complications.
Wireless devices were developed for very large
PDAs with excellent occlusion rates.
The buttoned device with the incorporated folding plug and the
wireless devices are the currently used devices. The safery record of
the new devices needs to be established with larger clinical trials.
INTRODUCTION
The Regular
Buttoned Device ( 1, 2 ) was
the first “Sideris” device to be used in the occlusion of patent ductus arteriosus, as early as 1991, by Dr. Rao.
It has been used in more than 400 cases since then; two hundred and eighty
four cases of PDA occlusion with the regular buttoned device have been
entered in the international register (Table).
The Infant
Buttoned Device( 3 ) was introduced in an attempt to be used in younger patients. The
occluder component of the regular buttoned device was replaced with a
single stainless steel wire occluder, covered with a rhomboid shaped
polyurethane foam; in addition to it a folding plug made-up of
polyurethane covering the button loop was also incorporated. During
buttoning the single strand occluder remained in the aorta, the
folding plug in the ductal lumen and the counter-occluder in the
pulmonary artery. Two standard sizes, 15 and 20 mm were manufactured.
Forty-eight cases have been entered the international register
by 7 investigators.
The PDA
Device with an Incorporated Folding Plug ( 4
) is the current
buttoned device used for PDA occlusion. It consists off an occluder
remaining on the aortic end of the ductus, a folding plug over the
adjustable button loop filling the ductal lumen and
a counter-occluder buttoned
with the occluder at the pulmonary artery end of the ductus (Fig 1).
Device sizes vary from 15 to 30mm. The device is currently used in FDA supervised clinical
trials in 10 US centers.
Twenty preliminary cases have entered the
international register.
Wire-less
Devices have been used in the occlusion of larger PDAs. They
include detachable balloons ( 6 )
and transcatheter patches ( 7 ); in both cases the balloon or the
balloon with the sleeve patch are occluding the ductus from the aortic
side occupying the ductal lumen as well and are temporarily supported
by a second balloon from the pulmonary artery end of the ductus (Fig
2). The detachable balloon is released acutely becoming flat in 2
months; the transcatheter patch requires 48 hour support and is then
released.
In a few PDA patients miscelanious devices like
the centering device, the centering on demand device or the
self-adjustable device have been used for specific reasons.
Method
The transvenous approach is used for the PDA
occlusion using most “Sideris” devices. The ductus is crossed from
the pulmonary artery using a multipurpose catheter; a 0.035”
exchange wire is positioned in the descending aorta. A long delivery
sheath (7-8 F) is positioned over the exchange wire in the descending
aorta. The occluder is introduced in the sheath and it is released in
the descending aorta; it is pulled back by the loading wire until it
stops on the aortic end of the ductus. Test aortograms are performed
by a small arterial catheter placed below the device. The occluder can
be re-positioned to optimize the position and the result.
Providing that the result is good, the counter-occluder is
released in the pulmonary artery and is buttoned with the occluder.
The device is subsequently released .
Patient and Device Selection
The PDA device with the folding plug was used for
ducti of all shapes with a minimal diameter between 3-12mm. Device
sizes varied between 15-30mm and the introducing sheath between 7-8F.
We used wireless methods for larger
PDAs ( sizes 12-22 mm). The balloon/patch can be introduced
transvenously through 9-13F sheaths according to size. It needs to
remain in place for 48 hours. The use of the transcatheter patch has
been reserved for older children and adults since it is relatively
bulky.
Results
The goal of the PDA device occlusion is full
occlusion, to eliminate significant shunts as well as the risk of
bacterial endocarditis.
The goal was not immediately achieved with the
regular buttoned device where full occlusion rates at 24 hours were
only 60% (Fig 3). However most PDAs
had hemodynamic improvement and the residual shunts diminished and
disappeared with time.
By the incorporation of the folding plug in the
infant buttoned device, full occlusion rates increased to 80%, within
24 hours from the procedure. The residual shunt was trivial with only
2/48 cases requiring a second device and all the residual shunt
disappearing.
Similar good occlusion rates have been used in
the first 20 cases of the currently used
PDA device with the folding plug. Full occlusion rates were up
to 84% within 24 hours from the procedure
and 94% in one year.
The occlusion results of the wireless devices
was even more impressive in the 4 cases used. The full
occlusion rate was 100% on implantation and on latest follow-up.
Complications
No acute serious complications have been seen
with any of the buttoned
or wireless devices described the last decade.
Six regular buttoned device patients had their
device pulled through the ductus and retrieved. Three of these
patients underwent a larger device implantation and three were sent to
Surgery.
During follow-up seven (2.5%) had re-intervention
to treat residual shunts two of them causing hemolysis.
Re-intervention included surgery (2), coil implantation (2) and a
second device (3).
No endocarditis, thrombus formation or LPA
stenosis has been reported. No late embolization has been seen as
well.
Because of unacceptably low full occlusion rates,
the use of the regular buttoned device has been discontinued for the
occlusion of patent ductus arteriosus.
No complications
have been reported with the infant buttoned device by 6/7
participating in the clinical trials investigators. A single
investigator observed sub clinical aortic perforations ( 5
). Because of that and despite the favorable results of the
other investigators, the use of the infant buttoned device was
suspended until collection and analysis of the data is completed.
No complications with the PDA device with the
folding plug have been reported.
Conclusions- Recommendations
The Button Device has been found effective and
safe in the occlusion of PDAs of all shapes . The recent modification
of the PDA device with the folding plug has been found to have higher
full occlusion rates than the regular buttoned device and is
recommended for PDAs 3-12mm.
The wire-less devices (transcatheter patch) are
highly effective in the occlusion of larger than 12mm
PDAs . Although no complications have been reported, the safety
record needs to be established by larger clinical trials.
References
- Rao
PS, Sideris EB, Haddad J, Rey C, Hausdorf G, Wilson AD, Smith PA,
Chopra PS. Transcatheter occlusion of patent ductus arteriosus
with adjustable buttoned device: initial clinical experience.
Circulation 1993, 88:1119-26
- Rao
PS, Kim SH, Choi J, et al. Follow-up results of transvenous
occlusion of patent ductus arteriosus with the buttoned device. J
Am Coll Cardiol 1999, 33:820-6
- Sideris
EB, Rey C, De Leso JS, Solymar L. Infant buttoned device for the
occlusion of patent ductus arteriosus-early clinical experience
(Abstract). Cardiol Young 1996, 6:56
- Sideris
EB, Rey C, De Leso JS et al . Occlusion of large patent ductus
arteriosus by buttoned devices with incorporated folding plugs.
Proceedings of the second World Congress of Pediatric Cardiology
and Cardiac Surgery 1998, 258
- Wilson
NJ, Occleshaw EJ, O’Donnell, et al. Subclinical aortic
perforation with the infant double-button patent ductus arteriosus
occluder. Cathet Cardiovasc Intervent 1999, 48:296-8
- Sideris
EB, Chiang CW, Zhang JC,
Wang WS. Transcatheter correction of heart defects by detachable
balloon buttoned devices: A feasibility study. JACC 1999;23:526A
- Sideris
E, Sideris S, Poursanov M, Toumanides S, et al. Transcatheter
patch correction of atrial septal defects: experimental validation
and early clinical experience. Cardiology in the Young 2000; 10:13
Table
1
DEVICES AND PATIENTS
Device
Patients
PDA Size
Sheath Size Min. Weight
mm
F Kg
Reg. Buttoned
284 3-15
(4)
7-8
3
Infant
48
3-5 (3.5)
6-7
7
F.Plug
20
3-12(5)
7-8
4
Wire-less
4 12-22
(17)
9-11
40
Figure
Legends
Figure 1.
PDA device with a Folding Plug:
a.
device construction; it consists off the occluder with the
folding plug on the button loop and the counter-occluder
b.
device function;
the occluder obstructs the arterial end of the ductus, the folding
plug is in the ductal lumen , the counter-occluder is buttoned
with the occluder at the pulmonary artery end of the ductus.
Figure 2
Transcatheter “sleeve” patch:
a. device construction; double support
balloon over a wire, radiopaque sleeve patch on the distal balloon
retrieval thread connected to the patch.
- Occlusion
of a 22 mm PDA by a 23
mm double balloon, supporting a transcatheter sleeve patch; full
occlusion was maintained after balloon withdrawal (48 hours).
COC= counter-occluder,
DB= distal balloon , FP=
folding plug, OCC= occluder , PB= proximal
balloon , TP=
transcatheter patch,
WR= wire
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