VOL.

No.

125,

3

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POLYVINYL

By

S. MURTHY

ALCOHOL EMBOLIC

TADAVARTHY,

M.D.,

(IVALON)-A MATERIAL*

JAMES

H.

MOLLER,

MINNEAPOLIS,

NEW

M.D.,

KURT

and

AMPLA’I’Z,

M.D.

MINNESOTA

ABSTRACT:

Successful nonsurgical treatment of gastrointestinal bleeding and arteriovenous malformations by embolization techniques has been previously documented. i) Compressed Ivalon sponge was found to be a suitable embolic material in animals and in four patients. 2) The material has been extensively used in surgery, and its biocompatibility has been proved. 3) Expansion of the compressed sponge to its original size after embolization makes this material extremely effective. Recanalization did not occur in animals and humans. ) For the occlusion of larger arteries, Ivalon can be wrapped around the guidewire. Ivalon sponge absorbs blood and serum, unwraps itself allowing withdrawal of the guidewire. ) Embolization procedures are not without risk since reflux of embolic material may occur. Therefore, these procedures have to be carried out lJnder fluoroscopic control. T is the purpose of this communication to report the experience with a synthetic embolic material which can be introduced through catheters in the management of gastrointestinal bleeders, arteriovenous malformations, hemangiomas, and traumatic rupture of blood vessels. Ivalon sponge, previously used extensively in surgery, has proved to be a good synthetic embolic material.

is dried and becomes hard, it retains its compressed shape. If placed into an aqueous medium as blood, the compressed sponge resumes its original uncompressed shape as seen in Figure I . The compressed sponge

mm

Ivalon, a polyvinyl alcohol, is converted into a sponge-like material by foaming agents and hardened with formaldehyde. It has been used as an ion exchange resin since this foam is a negatively charged colloid and strongly adsorbs cations. Ivalon is also well known to housewives who use it as a cleaning sponge. Polyvinyl alcohol foam has the ability to absorb water; and it is, therefore, used in industry for electroplating and photography. The material is inert and withstands the action of dilute acids, strong alkalis, and common detergents. Ivalon sponge has the unique property of being resilient and readily compressible when wet. If the compressed *

From

the Department of Radiology, University

work

was

supported

in part

by

USPHS

Grant

T12

HE

length

: .

material

after

being

expanded

to

soaked

in

.

1’

FIG. . figure being

of Minnesota i

Ivalon

in

saline. This excellent plastic memory makes this material particularly attractive for embolization procedures where the size of the embolus is always limited by catheter size.

BACKGROUND

This

long

mm

23

Hospitals, 5853

609

and

Compressed Ivalon expanded six times soaked in saline. Minneapolis,

2

Pol HE

06314.

Minnesota.

at the bottom as seen on the

of top

the after

S. M.

6io

J.

Tadavarthy,

H.

Moller

and

K. Amplatz

NOVEMBER,

5975

mensions

can be reduced by a factor of : I. If dried, the compressed material will retain its shape in spite of gas sterilization. If introduced into the blood stream, it will swell and resume its original shape. Ivalon sponge was soaked in heparin and

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10-15

j,-__

FIG.

2.

Ivalon

ethylene

plugs 240

in pre-loaded

tubes

ready

Clay

Adams

poly-

compressed

for gas sterilization.

in

a vice

and

dried.

One

half

to

mm diameter plugs were cut from the dried material with a hole punch similar to a cork borer or the instrument used to cut side holes on angiographic catheters. These I

PREVIOUS

USES

OF

IVALON

Ivalon sponge has been extensively used in experimental animals as a filling material following pneumonectomy. Autopsy examination revealed that Ivalon sponge is inert and readily invaded by fibrous tissue with a minimal amount of inflammatory cells.5 In 1949 it was first introduced for medical use by J. H. Grindlay5 at the Mayo Clinic. When it was used as a skin graft in experimental animals,7 microscopic examination revealed minimal cellular infiltration. In the 1960’s Ivalon was used as a skin substitute in patients with burns. Because of the pores in the foam, it was permeated with serum and adhered to the skin in one or two days. This material appears to serve as a scaffold for ingrowing connective tissue and becomes an integral part ofthe body. The sponge was also advocated for surgical treatment for rectal prolapse.3 Very recently Porstmann et al,9 used this material for nonsurgical closure of patent ductus arteriosus with excellent results. Polyvinyl alcohol sponge was the synthetic material of choice in the early days of cardiac surgery. The first surgical closure of septal defects in this institution was accomplished by this material; it was used for the reconstruction of the mitral valve in cases of mitral insufficiency, as reported by others.’ Although it was used for the repair of aneurysms, increasing rigidity with time made it necessary to replace it by more pliable and long lasting plastics such as dacron and teflon. However, the biocompatibility of Ivalon sponge has been well established.6 The Preparation of Ivalon Emboli. Ivalon plastic foam is highly compressible in the dry or wet stage. If the material is soaked in

heparin

and

compressed

in a vice,

its

di-

plugs

measured

a

few

mm

in

length

(Fig. Ivalon

pre-loaded in small plastic 2). Depending upon the size plugs, either Clay Adams 240

could

be

were

used

as

pre-loaded

tubes

and

tubing of the or

and

260

gas

sterilized. Care must be taken that only gas sterilization and no steam is used. Otherwise, the compressed plugs will cxpand due to absorption of water and will not be suitable for injection through catheters. At the time of embolization, the pre-loaded tubes are connected to the catheter, and the plugs are flushed into the catheter and blood vessel by forceful manual saline injection. It is very important to eliminate all constrictions between the loading tubes and the selective catheter

FIG.

3.

Selective

renal

Ivalon

angiogram

embolization.

of

a

dog

prior

to

VOL.

since rather these Downloaded from www.ajronline.org by 129.97.124.143 on 02/10/15 from IP address 129.97.124.143. Copyright ARRS. For personal use only; all rights reserved

No.

525,

Polyvinyl

3

the compressed rapidly, making emboli difficult. ANIMAL

The renal with Ivalon. 72

hours

Ivalon prompt

(Ivalon)-A

Ivalon

were was

embolized performed

embolization

of the

clots,

611

and

I,.



#{149} 14 ‘

I.

re-

renal

(Fig.

ofrecanalization

autogenous

Material

EXPERIMENTS

obstruction

evidence

Embolic

plugs swell delivery of

artery with 3 ; and ). Aortography performed one week postembolization revealed occlusion of the renal artery at its most proximal portion due to antegrade thrombosis. The dogs were sacrificed at the end of seven days, and the renal artery and kidneys were subjected to histologic examination. The gross specimen of kidney revealed thrombosis of the main renal artery (Fig. ). Histologic cxamination of the canine renal cortex revealed thrombosis of several renal arteries and noncanalization. The renal cortex showed several areas of hemorrhagic necrosis due to thrombosis of the intrarenal arteries. The problem of lysis and fragmentation which is commonly encountered with no

New

VI

arteries ofdogs Angiography

post

vealed

Alcohol

therefore,

does

not

1 .-.,

#{149}

j 5. The gross specimen reveals thrombosis as by arrow.

of the canine

FIG.

pointed

out

in

renal

artery

this

figure

exist.

This drawback has been well documented by several authors,2”#{176} both in humans and

,

‘#{149} Wm#{149}

I

It is very important to and inject the emboli as close to the lesion as possible. Otherwise, the possibility exists that embolic material may enter other arteries resulting in embolic infarctions. Furthermore, it is cxcanine

selectively

experiments. catheterize

tremely

important

that

the

emboli

are

in-

jected through

slowly, particularly after the flow the artery has decreased. If injection is performed rapidly, embolic material may reflux and embolize other arteries. This has been shown in our laboratory where the renal artery was successfully embolized by Ivalon plugs. At the time of post mortem, however, additional emboli were found in the contralateral renal artery. The gross specimen of the target kidney shows extensive hemorrhagic infarction

FIG. 4. Selective embolization renal

artery

renal reveals (arrow).

angiography complete

72

thrombosis

hours

‘‘V,

due

i

ney post-

of the

to embolization. revealed

The several

contralateral kidareas of infarction catheter was well in

(Fig.

6). Since

the

place

at the

of embolization,

that

the

time

embolization

of the

it is likely contralateral

6i

S. M.

2

f

J.

Tadavarthy,

H.

i..

Moller

and

rapidly

in size

sixteen

months.

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open as

K. Amplatz since of

tion

was

the

At

that

tion

of

a

liver

vealed

a huge

few

injected

emboli

age

oi

an

diagnosed treated

by

February,

1974,

transferred

to the for

as soon

Uni-

considera-

as a donor

be-

angiography

and

vascular

which

of the liver.

hepatic foci

stayed for

was

a candidate

supply-

7). Numerous

(Fig. opacified

evidence

re-

artery for

a

arteriovenous

long

shunt-

ing.

This prior

comparatively

was was

Hospitals

spaces

patient

plantation.

renal artery was due to reflux by a too forceful injection. One of the major advantages of this material is expansion to its original size upon exposure to blood. If the sponge is precompressed io: i, the plug will resume its original proportion after it has been embolized. At the time of embolization, therefore, there is a gradual decrease of flow due to complete obstruction of smaller arteries due to the expansion of the injected Ivalon emboli plugs. This gradual expansion of the embolic material results in a very effective and rapid occlusion of the arterial tree, as evidenced in animal experiments where

in

he was

liver

without

time

out

Abdominal

multiple

vascular due to kidney to force-

which

transplant

available.

ing

was totally infarcted selective embolization. In the contralateral ( arrows), certain areas were infarcted due ful injection of embolic material.

liver

Minnesota

came

the

he had

1973,

involvement

time

of

at

1975

However, his abdomen conin size; and a second explora-

diffuse

versity

kidney

noted

He

carried

revealed

FIG.6.Theright

was

January,

hemangioendothelioma.

radiation therapy. tinued to increase

L.

it

In

biopsy

NOVEMBER,

Decrease to

surgery

Ligation

in

thought

was

of the

hepatic

but due to the artery

was

Therefore,

large size not readily

it

was

for

the

liver

trans-

size

of

the

to

be

essential.

artery

was

liver

proposed;

of the liver, the hepatic accessible by surgery.

decided

to

attempt

trans-

resulted

in complete and rapid thrombosis of the superior mesenteric artery. Ten dogs were subjected to embolization of various arteries. Recently, barium impregnated Ivalon plugs have become commercially available, rendering the embolic material visible by roentgenography. At the present time, our experience is limited to non-opaque Ivalon. Another way to make Ivalon plugs radiopaque would be the incorporation of a stainless steel bead. REPORT CASE

male

I.

with

OF

FIG. 7. Selective hepatic artery

CASES

N. 0. is a four and one-half a liver

tumor

which

year has

old

grown

huge

liver

identified

hepatic angiogram and multiple feeding

mass. without

Numerous arteriovenous

vascular

reveals vessels spaces

shunting.

a large to the were

VOL.

catheter patic

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No.

125,

small

peripheral

hepatic

affected. It was,

hepatic

artery

therefore,

strainless

steel

branches,

would

have

decided

umbrella

to

which

613

cutdown

of

hepatic

artery

three

stainless

through

the

as

left

steel

the

catheter.

through

the

small

nylon

bristle

brushes

catheter

using

Ivalon seemed

to

brushes

and the

the

metal

of

flow through as evidenced

the

patient

tion

with

The and

were

placed

small

emboli

umbrellas, were

two

delivered

(Fig.

umbrella.

procedure

there

to showed rise

of

At was

the embolized by angiography.

material t throm

acted bus

the

the

and nylon

embolization to

______J

nidus

units,

funcwhich

ultimately returned to #{231}o units, his bilirubin rose as high as mgm but declined to 2.3 mgm. Shrinkage of the liver by approximately cm above the pubis was noted, but he developed more ascites and his abdominal girth

umbrella

did A

not change. follow-up

angiogram

vealed

complete

occlusion

at

its

origin

to the liver the aorta

(Fig.

9).

at the site

of the flow to branches

The collateral

pooling

of

he was had

a blood

and

received

massive in

to

became

of less

be

right

and

store At

glycogen. autopsy

the

a

tumor

replaced

tumor

was

to hepatic

soft arterial

It

that large

the

and

to

of was

nodular

necrotic embolization.

to

percent

glucose.

his

liver

the

found

was

A

field

felt

of

his

entire

was

lung

because

fact

di-

lethargic

io mgm

upper

metastatic.

hypoglycemic

intake

He

than

infusions

the

dem-

markedly

admission

arrest.

sugar

found

last

directly arteries

to be extremely

a respiratory

have

collateral

previously

was

his

noted

artery

of

in the

re-

1974,

hepatic arising phrenic

spaces

morning

hospital,

April,

branches inferior

vascular

minished. On the

in

of the

demonstration via and

Venous

onstrated

thought

constructed the stainless

with

flow from

nodule

FIG. 8. Guidewire (A) with specially blunt knob that was used to advance umbrella (B) and nylon brush (C).

artery

(arrow).

from

and

C

of hepatic

the liver was maintained via unnamed the aorta and inferior phrenic arteries.

no ar-

procedure, of liver

720

stainless

practically hepatic Obviously

9. Thrombosis

FIG.

comple-

as an excellent formation.

deterioration SGOT

via

8).

emboli were then delivered pile up at the site of the

blood tery

subsequen Subsequent

the

steel

a guidewire

tion

foreign

artery.

catheterized,

Since

pass

ad-

was inserted

umbrellas

could

a be

the catheter, enibolic ma-

brachial

selectively

un-

construct

with the guidewire through serving as a baffle for the injected terial (Fig. 8). The No. 7 French teflon catheter

for

Material

but

been

could

vanced

the

Embolic

was

main

via

New

embolization. Since the hehuge, injection of small emboli not be used in this case. The injection of emboli would have resulted in obstruction

of a few

the

(Ivalon)-A

Alcohol

arterial

artery

could small

Polyvinyl

3

was

that

he

poor

oral

unable

to

reddish-brown

liver.

A

possibly The

portion

of

secondary final

diag-

nosis was hemangiosarcoma of the liver with rnetastases to the lungs. Pathological examination of the common hepatic artery shows the stainless umbrellas, nylon brushes, and the spongy material, namely polyvinyl alcohol (Ivalon) (Fig. io). There was no distal em-

S. M.

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614

J.

Tadavarthy,

H.

Moller

FIG.

and

Selective

I 2.

artery FIG. 10. artery

Postmortem examination of the hepatic reveals thrombosis. The arrows point tothe stainless umbrellas, nylon brushes, and

wards

Ivalon

spongy

bolization

due

stainless

steel

There

was

hepatic

covered

to

bafile

the

umbrellas

created

and

antegrade

thrombosis

ing

a capillary

the and

age of formed the

J. S. was

Patient

II.

the

hemangioma two weeks. a massive

of the

neck

and

of the

right

forehead.

Two

episodes

main

was

very

vascular

and

given,

venous

an

angiogram

with

hemangioma

ear

at

II

tensive to the

I

.

feeders huge

13).

subclavian

of mas-

down

On

a

arterio-

There was congestive heart failure with the liver palpable cm below the right costal margin. The huge heart and pulmonary edema

FIG.

12;

of the

(Fig. II).

shunting

(Fig. right

embolized

to the mass.

output treat

failure.

this in

excluded

It

patient order

by to

additional

Feeders

were embolized

Some

were

as evidenced

branches 23,

feeders

from

the

catheterized

sudden

amputa-

14).

a

1974,

performed,

left

catherized Ivalon plugs

also by

(Fig.

the

and

right

brachial

a No.

cut

French

red

Kifa catheter was introduced selectively into the right thyrocervical trunk which was successfully embolized with Ivalon plugs (Fig. i ; and 16).

Some

of

subclavian

and

the

other

artery

embolized.

feeders

were

The

also

patient’s

from selectively

congestive

the

right

entered

heart

failure did not improve. Because of the potential danger of embolizing the internal cerebral circulation, embolization of the external circulation was carried out by

carotid

from

vascular

angiography reveals cxthe external carotid branches mass.

de-

angi-

from

selectively with

of the

artery

August was

high to

abdomen.

and

1975

supply to the huge mass. 1974, abdominal angiography

trunk

tion

to

(arrors)

embolization

thyrocervical and successfully

and

revealed

little

due

and

the

in

feeders

decided

performed

rapidly

sive external hemorrhage were treated with blood transfusions. A second course of prednisone

be

Ivalon

omas

as hay-

The lesion grew hemangioendothelioma

to

therefore,

was,

was

brushes.

diagnosed

felt

many

crease the vascular On August 19, by

nylon

were

NOVEMBER,

angiogram

reveals

extensive

by fibrin.

artery.

CASE

on

material

K. Amplatz

FIG.

13.

Note disappearance following Ivalon

of major embolization.

feeders

VOL.

125,

No.

Polyvinyl

3

Alcohol

New

Embolic

6i

Material

.

I’ Downloaded from www.ajronline.org by 129.97.124.143 on 02/10/15 from IP address 129.97.124.143. Copyright ARRS. For personal use only; all rights reserved

(Ivalon)-A

“.a

_____

of several feeders which are not named (arrows) from the right subclavian following embolization.

FIG.

14.

obliteration

Note

FIG. 16. Note thyrocervical feeder

surgical artery.

into gram

the

exposure

seen

and

the

and

left

external

vessels

subclavian

occipital

suitable

artery

were

identified

and

At the end of the procedure, to

the

the carotid

mass

left

external

ligated.

The

via

patient

as evidenced by improved alertness.

occipital artery showed

increase

were

(Fig. doses

in food there

thought 17). of

was

The

left

external

from

the

to

selective

right the

be

carotid

left

insignificant

and

catheterization

patient for

not

emboliza-

was

digitalis

ar-

subclavian

discharged

with

congestive

heart

failure.

In spite

intake

or

feeders

for

low

tient

of successful

remained

suggested

the

genital cardiac trocardiographic catherization was corrected

embolization,

in congestive

possibility anomaly and revealed surgically.

heart

the failure

of a complicating

pa-

which

con-

in spite of lacking dccclinical findings. Cardiac a cor

triatriatum

which

A third patient with an arteriovenous malformation of the spinal artery underwent successful Ivalon embolization. This

#{149}

#{149}

#{149} Smany artery

artery

tion

S

FIG. 15. Note thyrocervical

Small

artery, was sur-

no definite decrease in the size of the mass. A follow-up arch aortogram revealed practically no new feeders either from the right

.5

artery

teries.

no flow

improve-

Objectively,

of

cftotid

was selectively introduced carotid artery, and an angioperformed. Large feeding vessels from

was

left

was

ment

the

A catheter the external

embolized.

gically

of

sudden amputation of (arrow) artery and disappearance followi ng embolization.

feeders (arrows) to the huge

from the right vascular mass.

FIG. 17. An arch aortogram tion shows obliteration pare with Fig. II).

after complete embolizaof all major feeders (corn-

S. M.

6i6 case

will

be the

subject

J.

Tadavarthy,

of a separate

H.

report.

Moller

and

sively

used

K. Amplatz in

NOVEMBER,

general

and

1975

cardiac

sur-

9

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DISCUSSION

Angiomatous malformations with arteriovenous shunting are notoriously difficult to correct by surgery. Ligation of the feeding artery results in rapid recurrence due to development of new feeders. In general, only surgical excision of the malformation results in cure which is commonly not possible due to the location of the angiomatous

numerous embolic maclots,’0 silastic emboli, silastic balls, methacrylate,8 stainless steel pellets,4 muscle, etc., have been suggested as embolic material. Ideally the injected emboli should reach the site of the arteriovenous malformation and should not enter into the venous component. With the injection of methacrylate, a liquid polymer, the liquid material may enter the venous side and may become embolized into the pulmonary artery. Barium impregnated silastic balls are attractive. This embolic material is very difficult to handle since it tends to cling to the injection syringe and connecting tubing. Furthermore, since the catheters are very small, such barium balls are minute and difficult to see with the naked eye or roentgenography.

They

may

cause

only

the vessel, whereas in the case oflvalon, the emboli irreversibly result in ultimate complete occlusion. Autogenous clot tends to break up upon injection through small catheters and embolize arteries which are not feeding the

incomplete

occlusion

malformation. of

Tadavarthy, of Radiology of Minnesota

Minneapolis,

Minnesota

We Mary ration

cot

lysis

of

Furthermore, and

major disadvantages Ivalon sponge

recanalization

the

I.

2.

is one

of

Hospitals 5555

wish to give special thanks to Miss Scherman for her help in the prepaof this manuscript.

C. N., and SCHIRE, V. Ivalon baffle for posterior leaflet replacement in treatment of mitral insufficiency: follow-up study. Surgery, 1968, 63, 727-730. BOOKSTEIN, J. J., CHLOSTA, E. M., FOLEY, D., and WALTER, J. F. Transcathether hemostasis of gastrointestinal bleeding using modified autogenous clot. Radiology, 1974, 113, 277-

BARNARD,

285.

3.

C., and

B0UTSIS, operation

for

H. Ivalon-sponge-wrap

ELLIS, rectal

26 patients.

prolapse:

Dis.

Colon

with

experience

&

Rectum,

17,

1974,

2 1-37. 4.

J. L., DiCHIRO,

DOPPMAN,

Obliteration formation Lancet, 5. GRINDLAY,

G., and OMMAYA,

A. arteriovenous malembolization.

of spinalcord by percutaneous Zj’J, 477.

1968,

J. H.,

sponge

and

prosthesis

0.

CLAGETT, for

use

after

T.

Plastic

pneumonec-

preliminary report of experimental Proc. Staff Meet. Mayo Ciin., 1949, 24, I 538-I 539. 6. HAWE, A., and RASTELLI, G. C. Late deterioraration of intracardiac Ivalan sponge patches. 7. Thoracic & Cardiovasc. Surg., 1969, 8, 87tomy:

study.

7.

9’. HOGEMAN,

K. E., GUSTAFSON, surgical sponge

G. Ivalon cover

of

experimental

preliminary 121,

8.

possibility

of this technique. seems to be an ideal

M.D.

REFERENCES

malformation.

In recent years terials as autogenous barium impregnated

by

S. Murthy Department University

report.

Ada

G., and BJORLIN, used as temporary skin chir.

defects scandinav.,

in

rats: 1961,

83-89.

A. J., and SPENCE, W. T. Clinical artificial embolization of cerebral arteries. 7.A.M.A., I 960, 172, I I 53-I I 55. PORSTMANN, W., WIERNY, L., WARNKE, H., GERSTBERGER, G., and ROMANIUK, P. A.

LUESSENHOP,

notes:

the

agent for securing permanent hemostasis and promoti ng thrombosis.” The compressed sponge is readily injected and swells upon contact with blood. Incomplete occlusion of small arteries is, therefore, prevented. Once expanded, it is invaded by fibrocytes and becomes part of the patient tissue. Therefore, the material has been exten-

9.

Catheter

closure

Radiol. 10.

Clin.

J.,

RoscH,

Selective for

control

acute

S. M.,

C.,

SNYDER,

transcatheter III,

and arterial

13-16.

and

gastrointestinal 102,

arteriosus.

9, 203-218. BROWN, M. new method bleeding.

1971,

embolization:

I 972,

TADAvARTHY,

1974,

C. T.,

DOTTER,

of

ductus

America,

arterial

Radiology, II.

of patent

North

J.

303-306.

KNIGHT, AMPLATZ,

L., Ovrrr, T. W., K. Therapeutic

embolization.

Radiology,

Polyvinyl alcohol (Ivalon)--a new embolic material.

Successful nonsurgical treatment of gastrointestinal bleeding and arteriovenous malformations by embolization techniques has been previously documente...
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