Cardiovascular Victor Sergey
S. Saveliev, V. Saveliev,
Patent Closure Transvenous the patent conical
MD MD
Vladimir
#{149} Vitali
Ductus with
that
consists
E. Verin,
of a
of poly-
urethane foam mounted on a stainless steel frame. Since 1981, the procedure has been performed in 273 patients in Russia. Permanent complete ductus closure was achieved in 258 (95%) patients. In eight cases (3%), the occlusion was incomplete. Complications occurred in 10 patients (4%), seven of whom required emergency surgery. The new technique combines certain advantages of both alternative methods. The conical shape of the occlusion device is well suited for the anatomic structure of the ductus. The possibility of selecting the size of the device permits reduction in the rate of incomplete closure while still taking advantage of transvenous delivery to avoid entrysite problems. In the initial 10 years of experience, the described technique proved effective, safe, and applicable in the vast majority of patients older than 2 years. Index
term:
Radiology
Ductus 1992;
arteriosus,
MD
Stepan
I
ductus
arteriosus
(FDA)
without
a novel method of FDA closure with transvenous occluder devise was de-
veloped (9) and Our experience
put into practice (10,11). is reported herein.
AND Device
device
Delivery
for ocdusion
SovECs,
Moscow)
of polyurethane
steel
foam
frame
is compressed
BN-1;
is a conical
the latter,
assuming
with
metallic of Surgery
(V.5.5.)
and
the
Center oflnterventional Radiology (V.P., 5K., S.S., V.V.), the Second Moscow Medical Instibite, First Moscow Hospital, Moscow. From the 1991
RSNA scientific assembly. Received De6, 1991; revision requested January 2, 1992; revision received February 28; accepted March 16. Address reprint requests to V.E.V., Cardiology Center, University Hospital, 1211 Geneva 4, Switzerland. #{176}RSNA, 1992
cember
oc-
conical
into the extruded
springs shape.
open, The
frame features a crown of fixing (six in smaller devices or eight in
hooks larger devices). end, the frame
catheter
mounted
the help of a
the occiuder
its original
plug
(Fig 1). The
loading device for introduction introducer sheath. When being
from
size
thrust
cath-
opposite end and unscrewing
of the stylet for screwing the connection between
the stylet and the ocduder; and nel-shaped loader to compress cluder so that it can be inserted guiding catheter. The introducer sheath comes sizes:
10,
and
12, 14,
and
in four diameter
13.5 F in correspond-
Procedure
Transcatheter PDA closure and a therapeutic
consists of a stage. Clo-
diagnostic
sure is performed local anesthesia
dren
the
diameter.
inner
Occlusion
a
into
16 F in outer
7.5, 9.0, 10.5, and
ing
(d) a funthe oc-
and with
sia in young
percutaneously in adults and
general
older
ketamine
with chil-
anesthe-
children.
the hemodynamic
the right
atrium,
right
parame-
ventricle,
and
catheter (Fig 3) or with the catheter the FDA from the venous side (Fig 4). For closure of the FDA with the device,
of the patent
(Botallooccluder
arteriosus
cluder
same
the pulmonary artery are catheterized via the right femoral or left subclavian vein. Angiography of the FDA is performed in the lateral projection with a retrograde
METHODS
and
(the
aortic across
on a stainless
Faculty
the device
To evaluate
consisting
the
onto
eter is used with the four sizes of the device); (c) a torquer-damp to be put on the
ters,
The
From
tho-
racotomy (1). This technique proved efficacious in terms of complete ductus closure (2-4). However, the technical complexity, restriction to a mainly adult population, and important rate of arterial entry-site complications hampered its popularity. In 1979, Rashkind and Cuaso, in the United States, presented a single-disk FDA occiuder suitable for use in small children and infants (5). Two years later, the multicenter clinical trial with the double-disk Rashkind FDA occluder (USC!, Billerica, Mass) was opened (6-8). In 1981, at the First Moscow Hospital,
ductus NTK
I
which includes a thin-walled Teflon outer catheter (introducer sheath) and an inner end-hole, conical-tipped catheter; (b) a thrust catheter with a 95-cm-long solid stainless steel stylet inside it to be screwed
1967, Porstmann et al, in the former German Democratic Republic, reported a method of transfemoral occlusion of the patent N
Occlusion System
184:341-344
MD
Transcatheter Technique’
MATERIALS
51.146
M. Kolody,
#{149}
MD
Arteriosus: a Transvenous
closure is described ductus arteriosus with
device
I. Prokubovski,
#{149}
Radiology
At its thinner can be affixed
of the delivery
(pulmonary) to the thrust
system
with
a sim-
ple screw-type (bolt-and-nut) attach-release mechanism. The device is currently available in the four sizes of 8, 10, 12, and 14 mm in diameter at its wider (aortic)
the ductus is passed from the pulmonary artery with the coaxial system (Fig 5, A) with lateral fluoroscopic guidance. The inner catheter is withdrawn, leaving the introducer sheath with its distal end in the descending aorta. If this manipulation leads to disappearance of the characteristic continuous flow murmur, the occluder is introduced;
otherwise, This tactic,
is substituted.
ence
shows,
serves
a larger catheter as our expen-
as a good
safeguard
that permits us to choose the adequate occluder size for each particular FDA.
Then stylet been
the device of the
is screwed
thrust
moistened
catheter,
with
contrast
onto which
the has
medium
for
end. The
delivery
(a) a coaxial
system
radiopaque
(Fig 2) consists
catheter
set,
of
Abbreviation: sus.
PDA
=
patent
ductus
arterio-
341
ab Figure 1. (a) Schematic presentation of Botalloocciuder: the polyurethane foam (a); the fixing hooks (b), the proximal ends of which are put in a metallic holder in the form of a cartridge; and the holder (c), which is provided with an external thread with which to attach the device to the thrust catheter. (b) Various sizes of Botallooccluders (8, 12, 10, and 14 mm, from left to right). Note the crown of hooks for attachment in the ductus.
better fluoroscopic manually pushed
the loader,
visualization, into the loader.
the device
Figure 2. Delivery set cludes Botallooccluder loader (B), thrust catheter clamp on the opposite and inner catheter (D), ducer sheath) (E).
for the system in(A), funnel-shaped with a torquer-
end
(C),
of the stylet
outer
catheter
(intro-
and is Through
is introduced
into
the introducer sheath with its larger end first and is advanced to the end of the sheath (Fig 5, B). The sheath is then pulled back jointly with the device to a point as close as possible to the aortic origin of the
PDA. Then
the sheath
drawn
further
truded
into the aortic
occluder
while
assumes
the entire
is carefully the device
lumen
(Fig 5, C). The
its original
delivery
system
ter, thrust catheter, slowly withdrawn the Botallooccluder D). At this moment,
withis ex-
shape,
and
(guiding
cathe-
and Botallooccluder) is into the ductus until is firmly stuck (Fig 5, the occiuder obturates
the lumen; the fixing hooks penetrate into the walls of the PDA and prevent dislocation
of the
artery thrust (Fig
device
by action catheter
toward
5, E, F), leaving
ductus
(Figs
the
It is important
occluder
to note insertion
this
a.
pulmonary
in
the
b.
Figure 3. (a) Aortogram in the lateral projection about 5 mm in diameter in a 26-year-old woman. after insertion of the Botallooccluder demonstrates
demonstrates (b) Repeated complete
that route
only
canalization closure.
tium
of the
two
patients
and
of the ductus after and sex distribution
Age
shown
in the
were
Table.
being
treated
for transluminal
as (a) severe with balanced
pulmonary hypertenor tight-to-left shunting,
PDA of more
(b)
than
in its narrowest
part,
PDA (window FDA.
type),
the Botallooccluder and
permanent
in these particular these contraindications than 15% of patients Transcatheter tempted
2-43
342
in a total years, including
Radiology
#{149}
There were no entry-site tions in this series. Immediate
ductus
occlusion
situations. However, occurred in fewer FDA
with PDA. closure was
of 273 patients 13 patients
ataged with
In three
do-
complicaemboli-
to position
vice
the
occluder
bifurcation
four cal
of the
patients retrieval
taneous patients, termine leased
correctly
embolized
device
in the
into
abdominal
underwent of the
the
aorta.
urgent with
All
surgisimul-
ligation of the PDA. In three following the failure to dethe precise location of the the
in one
in
of the
patient.
device was prematurely after it was attached to the
patients,
because
of under-
estimation of the size of the ductus, the device could not be fixed properly in the FDA; therefore, the occluder embolized into the pulmonary artery. In all three of these patients, the FDA was
PDA, re-
FDA
zation of the device occurred in seven patients. In four cases, due to failure device
aorta
wall
FDA.
Among the 273 patients with deemed suitable for transcatheter treatment, successful permanent sure was achieved in 258 (95%).
the
artery
to the
patients required surgical for removal of the misoccluder and for ligation of the
placed
RESULTS
subclavian
and
three
intervention
FDA, b-d reflect that use of cannot ensure reliable
Contraindications fixation
10 mm in diameter (c) short cylindrical or (ii) aneurysm of
left
descending
These
FDA occlusion. Informed consent was obtamed from all adult patients and from the parents of children. Thirty-four patients (11%) were excluded for contraindications such sion
surgical are
Indications
Between December 1981 and November 1991, cardiac catheterization was performed in 307 patients older than 2 years
who
that is 10 minutes
the
is possible
device.
Patients
a PDA (arrowheads) aortogram obtained closure of the FDA.
3, 4).
transvenous
with
the
of the aortic pressure. The is screwed off the occluder
reos-
larger
closed
after
device, was
left
insertion
while in the
of a second
the
migrated
pulmonary
deartery
bed (it is not usually feasible to retrieve an embolized occluder from the pulmonary artery branch because the occluder is easily stuck there). Two of these patients developed the clinical signs and symptoms of localized pneumonia,
days, enced
which
while the third no sequelae.
resolved
patient
within
6
experi-
August
1992
the
failures
curred
and
complications
during
curve
for
the
the
early
oc-
learning
procedure.
In the
most only
recent 100 consecutive patients, one device embolized into the and only two incomplete FDA sures
aorta clo-
occurred.
DISCUSSION Existing techniques ter FDA closure have comings. The efficacy Porstmann (12-14),
in the lateral projection with the that is about 3 mm in diameter initial angiogram in a was obtained
catheter across in a 4-year-old demonstrates
the ductus demongirl. (b) Follow-up complete closure of
the PDA.
I Figure
5.
Schematic of PDA do-
diagram
sure with loocciuder.
the Botal(A) PDA is
passed monary
from the pulartery with the
coaxial
system.
vice is introduced the introducer
(B)
De-
into sheath
with the larger end first and is advanced the
A
is high (93%-95%) of entry-site corn-
plications is important (8%) (12). With the initial Rashkind device, successful FDA closure was achieved in 66% of
b. Figure 4. (a) Angiogram strates a PDA (arrowheads) aortogram 3 years after
method the rate
but
for transcathespecific shortof the original
end
of the
(C) The sheath fully
withdrawn
the device
cases
(8).
tions
were
device, FDA
possible
with
is carewhile
is extruded
the
the Porstmann the
plug
ductus
are
and
enabling wedged
made
ductus pletely
not
C
of
in of
aortic
neck,
fixation by being narrowest part of the fixed, the plug cornaorticopulmonary
can be achieved
lat-
a wide
pulmonary
reliable into the (3). Once interrupts
or
the pulmonary To this end, the
with
a small
does
the
in
fit snugly
dislocation
the plug into either artery or the aorta.
PDA
leaving
device
must
to prevent
screwed
ter in the ductus.
sys-
technique, has been
Rashkind
shunting
cluder,
delivery
and the occlusion
into the aortic lumen. (D) The delivery system is slowly withdrawn into the ductus until the device is firmly stuck. (E, F) The thrust catheter is
off the oc-
modifica-
in the
80%-85% of cases (15,16). A FDA is usually funnel shaped conical (3,17,18). The polyvinyl-alcohol (Ivalon; San Diego, Calif) foam
plugs
sheath.
after
made
tern, the complete
base to
However,
through
the
ductus.
In contrast, the Rashkind occluder is composed of two spring assemblies that resemble two opposing umbrellas (8). Stable fixation of the device in the
of the
more
guarantee
ductus.
easily
complete
Residual
but
closure
transductal
shunting occurs in 15%-20% of patients (16,19). On the other hand, there are virtually no entry-site problems because of the transvenous approach and of the small caliber of the delivery
system.
The Botallooccluder seems to cornbine certain advantages of both alternative methods. It is conical in shape and
E
thus
the ductus the size of tion in the while still transvenous avoids the problems.
F
We
Left-to-right eight patients
shunting persisted despite successful
plantation of the occluder. these patients underwent
Volume
184
#{149} Number
2
Four elective
in imof sur-
gical ligation. In the remaining four patients, the residual ductal leak was judged to be insignificant. There was no mortality, and most of
fits
the
anatomic
structure
of
well. The ability to select the device permits reducrate of incomplete closure taking advantage of the delivery route, which possibility of entry-site
observed
incomplete
closure
in
3% of cases mostly at the beginning of our experience. This problem can be avoided by careful selection of the size
of the
shunting
Botallooccluder.
with
the
Residual
Rashkind
occluder
Radiology
343
#{149}
seems
to be independent
of the
oper-
ator’s skill; obviously, it is a problem of use of an insufficient amount of foam in large PDAs (15). Embolic complications occur in 2%-5%
of cases
that
make
use
of the
Porstmann technique (12) and the current Rashkind occluder (15,20). The Botallooccluder embolized in 3% of cases during or just after implantation, while misplacement of the device in the left subclavian ostium or against the aortic wall occurred in an additional 1 % of cases. The rate of embolic complications appears to decrease with all methods as more experience is achieved (12,15). The outer diameter of the thinnest introducer sheath used in the First Moscow Hospital is 10 F. Thus, the Botallooccluder could possibly be used in patients under the age of 2 years. Yet, there is little risk in postponing occlusion of a PDA until the patient is 4-6 years old (3), when 1014-F catheters can easily be inserted into the femoral vein. In the first 10 years of experience, the Botallooccluder has proved to be a valid instrument for closure of FDAs. The device seems to combine simplicity with high efficiency and acceptable safety. It can be employed in any catheterization laboratory by radiologists or cardiologists experienced in interventional
dures.
cardiologic
3.
4.
5.
6.
7.
8.
344
Radiology
#{149}
H. arteno9:203-218.
CC.
ductus
14.
Transcatheter
arteriosus:
suc-
catheterization
disease. Rashkind
in congenital
15.
hon 9.
Saveliev
Rashkind
PDA
occluder
VS. Prokubovski
VI, Kolody
12.
18.
SM,
Saveliev SV. Indications and contraindications to transluminal closure of patent ductus artenosus. Grud Khirurgiia 1987;
catheter
Plug by Chest 1977;
method.
1989; 79:1153-1159.
Saveliev giographic arteriosus.
SV, Kolody
SM, Verin
anatomy Vestn
Krichenko
yE.
of the patent
Roentgenol
A, Benson
An-
ductus
Radiol
1988;
P. MOes Angiographic classification of the isolated, persistently patent ductus arteriosus and implications for percutaneous catheter occlusion. Am J Cardiol 1989; 63:877-880. DyckJD, Benson LN, Smallhorn JF,
CAF, McLaughlin
system.
117. Prokubovski VI, Kolody SM, Saveliev SV, et al. Transluminal closure of the patent ductus arteriosus with transvenous approach: alternative to the surgery. Grud Khirurgiia 1988; 1:42-47.
K, Naito Y, et at. ductus arteriosus
4:5-8.
1987; 75:583-592.
et al. Interventional radiology: new direclion in prophylaxis and treatment of surgical disease. Khirurgiia (Mosk) 1984; 8:113-
S, Sato of patent
70:631-635. Takamiya M. Experience of consecutive 135 cases treated by Porstmann’s method (plug closure of PDA) and present status of his method in Japan. Radiol Diagn 1987; 28:463-464. Hellenbrand WE, Mullins CE. Catheter closure of congenital cardiac defects. Cardiol Clin 1989; 7:351-368. Mullins CE. Pediatric and congenital therapeutic cardiac catheterization. Circu-
lation 17.
Cardiovasc Clvi 1985; 15:303-316. WJ, Mullins CE, Hellenbrand
of the
Circulation
16.
heart
WE, Tait MA. Nonsurgical closure of patent ductus artenosus: clinical applica-
11.
2.
of patent
Kitamura closure
transfemoral
ROFO
use in a 3.5-kg infant. Pediatr Cardiol 1979; 1:3-7. Rashkind WJ. Transcatheter treatment of congenital heart disease. Circulation 1983; 67:711-716. Rashkind WJ, Tait MA. Interventional
cardiac
References H. Der persistens Thorax-
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cessful
proce-
L, Warnke arteriosus I. Mitteilung. 15:199-203. Wierny L, Warnke Catheter closure of patent ductus sus. Radiol Clin North Am 1971;
thorakotomie.
1968; 109:146-148. Rashkind WJ, Cuaso
closure
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Porstmann verschluss
ohne
U
Porstmann W, verschluss des ohne thorakotomie. chirurgie 1967; Porstmann W,
W, Wierny L. Percutaneous closure of the patent ductus an alternative to surgery. Semin 1981; 16:95-102. W, Wierny L, Warnke H. Der des ductus arteriosus persistens
Roentgenol
Acknowledgments: We are indebted to Bernhard Meier, MD, Alain Batawi, MD, and Abhay K. Pande, MD, for their help in preparation of the manuscript.
1.
Porstmann transfemoral arteriosus:
19.
LN,
Burrows
P. Freedom
RM.
McLaughlin PR, Freedom RM, Rowe RD. Catheter occlusion of the persistently patent ductus arteriosus. Am J Cardiol 20.
1988; 62:1089-1092. All Khan MA, Mullins
Percutaneous tus arteriosus adults.
CE, Nihil
MR,
et at.
catheter closure of the ducin children and young
Am J Cardiol
1989;
64:218-221.
6:30-33. Wierny L, Plass R, Porstmann W. Transluminal closure of patent ductus arteriosus: long-term results of 208 cases treated without thoracotomy. Cardiovasc lntervent Radiol 1986; 9:279-285.
August
1992