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-

II. Mitteilung.

13.

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

10.

Wierny ductus

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

Patent ductus arteriosus: transcatheter closure with a transvenous technique.

Transvenous closure is described of the patent ductus arteriosus with a conical device that consists of polyurethane foam mounted on a stainless steel...
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