Aspiration Clinical

Catheter Results’

Roif W. Guenther, Dierk Vorwerk,

for

Percutaneous

Thrombectomy:

MD MD

The clinical application of an aspiration thrombectomy system is presented. The system consists of a 7-F Teflon catheter with a rotating coaxial propeller-tipped wire. Thrombectomy was successful in treating occlusion of two femoropopliteal arteries and one hemodialysis implant but was not completely successful in a draining shunt vein. Preliminary results are encouraging; mechanical thrombectomy may offer an alternative to local lysis

therapy.

Index terms: Arteries, extremities, 92.72 Catheters and catheterization, technology Shunts, arteriovenous, 91.456 #{149} Thrombosis, terial, 92.72, 912.456 #{149} Thrombosis, venous, 916.751 Radiology

#{149}

ar-

Figure

new mechanical thrombectomy catheter was designed for percutaneous thrombectomy as an alternative to lysis therapy and surgical revision of thrombosed vessels. Herein, we present our first clinical results with this new device.

and

Methods

The new thrombectomy catheter (Cook, Europe) consists of an 80-cmlong 7-F thin-walled Teflon catheter with an inner lumen of 1.8 mm, which is combined with a coaxial 0.4-mm propeller-tipped wire (Fig 1). The propel1cr (which has a span of 1.2 mm) is soldered to the distal end of the wire and does not protrude beyond the catheter tip. The wire is adapted to a small, waterproof 25-V DC motor unit and can be rotated at 500-1,000 rpm. Continuous suction is established by means of a conventional roller pump (Fresenius, Bad Homburg, Federal Republic of Germany) and reaches 7.2 kPa of vacuum at 50 rpm (101.5 kPa of air pressure). The roller pump allows continuous transport of clot material; the suction tube is adapted via a side-arm adapter,

I

From

ogy,

the

Department

Technical

strasse,

D-5100

Received

requested

November

print (

28; accepted

requests RSNA,

of Aachen,

Aachen,

Germany. vember

of Diagnostic

University

Federal

September 2; revision

December

to R.W.G. 1990

b. 1.

(a) The 7-F motor (*). Arrow

proof thrombectomy

1990; 175:271-273

Materials

a.

Radiol-

aspiration

thrombectomy

indicates side-arm shows the propeller

catheter

prototype

systems

(1),

a 7-F

catheter

was used in three patients for percutaneous thrombus removal. In all cases, the catheter was inserted via a 7-F conventional angiographic sheath provided with a side port, which allows perfusion of heparinized saline solution and injection of contrast medium to monitor catheter position and progress of thrombus removal. In all cases a prototype system was used, but a commercially available system is being developed. Approval has not yet been applied for from the U.S. Food and Drug Administration. Aspiration thrombectomy was performed as an emergency procedure in two of the patients (in one femoral artery and in one poplitcal artery) and because of an occluded hemodialysis fistula in the third patient.

Republic

of

revision

received

No-

6. Address

re-

Results Case 1.-A 65-year-old man with severe claudication (type Fontaine IIb) was admitted for dilation of a high-

(arrowheads)

adapter for suction. within the lumen.

which has the same inner diameter as the catheter to permit easy passage of aspirated thrombotic fragments to the suction tube. An additional side-arm fitting allows the tube to be flushed with saline. Once the catheter tip is placed within the thrombus, suction and propeller rotation arc simultaneously activated. Thrombus fragments are collected in a bottle, and the quantity of aspirated blood is carefully monitored. After in vitro testing of 7- and 10-F

Pauwels-

7. 1989;

catheter

(b) Detail

linked

to a water-

of the 7-F aspiration

grade stenosis of the right superficial femoral artery. However, antegrade angiography performed before dilation showed that the superficial femoral artery had become totally occluded. Additionally, severe changes of the tibioperoneal trunk were seen, including total occlusion of both the posterior tibial and the proximal peroneal arteries. Collateral flow kept the distal peroneal artery open. Severe atherosclerotic changes of the anterior tibial artery were also seen (Fig 2). The femoral occlusion was passed with a 0.7-mm straight guide wire and dilated with a 5-mm 5-F balloon catheter (Medi-tech, Watertown, Mass). Before dilation, 5,000 IU of heparin was administered intraarterially. The dilation was successful, but subsequent angiography revealed distal embolization of thrombus material, which led to total occlusion of the anterior tibial artery and subtotal occlusion of the poplitcal artery. Since subsequent intraarterial lysis with 150,000 IU of urokinase within 1 hour accomplished only minor reduction of the thrombus, mechanical thrombectomy was performed with the 7-F catheter system. The system was inserted twice into the tibioperoneal trunk, and angiography revealed complete removal of both the popliteal and the tibial thrombi (Fig 2c, 2d). A small thrombus, however, remained within a medially located collateral artery. A total of 100 mL of blood and saline was aspirated, but actual blood loss was less than 50 mL. Postprocedural treatment included in271

a.

b. artery artery,

row),

arrow).

Collateral

superficial

femoral

and

balloon

occlusion

dilation

of the

of a

anterior

short-segment

tibia!

artery

occlusion

(solid of

the

row), which caused an incomplete obstruction. In addition, lus was successfully removed by using the embolectomy tion of the procedure, most of the embolized clot material catheter is still in place (arrowhead).

travenous administration of heparin (1,000 lU/h) for 72 hours. The patient was asymptomatic, and his ipsilateral ankle-arm index was 0.9. He was discharged 3 days after treatment. Clinical follow-up for 6 months revealed no symptoms of restenosis. Case 2.-In a 47-year-old man, dilation of two adjacent stenoses of the right superficial femoral artery was performed with a 5-mm balloon catheter (5-F shaft). Heparin, 4,000 IU, was administered before dilation. Dissection occurred in both lesions after dilation, which led to a subtotal occlusion of the vascular lumen and impaired blood flow. A self-expandable stent (Wallstent, Medinvent, Lausanne, Switzerland; diameter of 6 mm, length of 3.5 cm) was placed on the proximal lesion via a 7-F sheath and resulted in complete restoration of the lumen. A second stcnt delivery system was inserted for placement in the distal lesion, but a small trapped thrombus was seen at the end of the J guide wire in the distal superficial femoral artery. The origin of the thrombus was unknown but presumably was associated with the angiographic sheath. Consequently, local lysis therapy was initiat272

.

Radiology

d.

C.

Figure 2. Case 1. Embolization of popliteal and tibioperoneal seen before embolization: occlusion of the proximal peroneal

after balloon which is kept vessels

dilation. (a) Severe open by collateral

from

artery,

an

the

popliteal

embolus

the tibioperoneal trunk catheter, which was then is removed; only a small

and was cial

was

progressively

advanced,

most of the thrombotic material quickly removed from the superfifemoral artery at the first attempt.

During

the

procedure,

part

of

Only

small embolus al artery, which with

the

Once

could

After heparin

was

completed

reached

intervention

no

lU/h)

patient

Case

3.-A

renal

His

index

was was

72

an

occluded

(PTFE)

hemodialysis

had

occurred

fore

admission.

tency

was

1.0,

and

attempted

all

Occlusion of

begraft

exclusively

means.

a

in

The

implant

was

fashion,

and

sheath

until

chial

artery

easily in

completely

the

not

this

reason,

of

the

a 7-F angiographic anastomosis

at

the

bra-

reached. The thrombus removed in the treated PTFE Via a second access site obwas

an

antegrade

fashion,

catheter into graft

clean

Consequently,

was

catheinto the

segment

via

pa-

by

shunt

retrograde

proximal

PTFE

of

12 hours

Restoration

Thrombectomy

the

with because

fistula.

overnight,

and

hours,

seen

polytetrafluorethylene

advanced

of

occlu-

woman was

implant

loss

An-

6 months or

65-year-old

quently

discharged.

ar-

palpable.

stenosis

insufficiency

remaining for

(b) After

at 3 and

residual

fin-

blood

were

thrombectomy

administration

asymptomatic ankle-arm

stent

seen. (straight

sion.

segment.

100 mL.

intravenous (1,000

showed

on the

was

a second

Approximate

than

follow-up

was

perone-

be

pulses

giographic

tamed

the

lesion.

less

in the not

peripheral

occluded

a

catheter.

by placing

distal

was

remained

embolectomy

successfully,

ished

thrombus.

also

is seen

the activated 7-F thrombectomy ter was advanced continuously

the

ration

residual

are

artery

punctured

occludcatheinto aspi-

the

(arrowhead) popliteal

percutaneous

thrombus migrated distally and ed the tibioperoneal trunk. The ter was then selectively introduced the peroneal artery, thus allowing of

the

trunk are (open ar-

occluded (curved arrow). (c) The popliteal embointo the tibioperoneal trunk. (d) After compleremains within a collateral artery (arrow). The

ed. While lysis therapy with 150,000 IU of urokinase and 1,000 IU of heparin was performed for 1 hour, obstruction due to thrombus formation increased and led to total occlusion of the superficial femoral and popliteal arteries. As a last resort before surgery, aspiration thrombectomy was attempted. The 7-F mechanical thrombectomy catheter

artery

within

is also advanced embolus

changes of the tibioperoneal vessels in the distal portion

was

the subse-

into the distal PTFE the draining vein. was successful in the segment

the

but

adequate

established a Fogarty

did

draining blood

in the balloon

not

vein. flow

shunt.

For was

April

in-

1990

serted draining

through vein,

the and

thrombus

was

pulled

7-F sheath into the remaining through

the

the

puncture hole as soon as the angiographic sheath was removed, thus obviating surgical incision. No additional stenosis of the shunt system was detected, and flow was completely restored. Blood loss was less than 100 mL. Hemodialysis was performed via the PTFE shunt directly after treatment, and heparin therapy (1,000 lU/h) was continued for 24 hours.

Function

ing

has

a follow-up

not

decreased

dur-

of 5 months.

minimal

Discussion Percutaneous treatment of fresh emboli and thrombi still remains problematic. Local lysis therapy with urokinase or streptokinase and simple aspiration have been described as alternatives to surgery. Local lysis therapy has been regarded as the percutaneous method of choice for fresh thrombus formation in

shunts

(2,3)

or

peripheral

arteries,

especially if thrombotic occlusion occurs as a complication of interventional procedures such as angioplasty (4). Starck and co-workers reported good results with simple aspiration without mechanical thrombus fragmentation as an alternative or supplement to lysis therapy

(5).

performed manual

with aspiration,

insertion

of

This

the

technique,

however,

5-9-F catheters and requires repeated catheter

system

and

up

for

clot

transportation

(6).

A sim-

ilar device was designed by Beck et al (7) and utilizes both suction and thrombus fragmentation with a spiral drill at low speeds (50 rpm). Alternatively, Bildsoe and co-workers

presented

experimental

a mechanical

Volume

system

175

#{149} Number

results

for

clot

1

pulveriza-

with

reduction

of the inner tively large tion. Catheter posits

of

the

cross

around

the

wire

the

wall

will

be

damaged

by

the

from

the

arteries

manage postangioplasty such as thrombotic sion

of

the

femoropoplitcal

and

thrombosis save

or both

time.

1.

Guenther

and

RW,

Vorwerk

Radiol 2.

A new

Smith

with

J Intervent

wire.

press).

T, Hunter

DW,

WR,

synthetic

Darcy

Amplatz

angioplasty.

MD,

K.

hemodialysis

Castan-

Thrombosed

access

of combined

fistulas:

thrombectomy

AJR

147:161-163. J, Maroney Thrombosed dialysis

G, Dowd

C, Bookstein

Lang

E, Halasz

N.

grafts: efficacy of intrathrombotic tion of concentrated urokinase,

4.

and

149:

177-181.

Roth

FJ.

Heimig

alisation

peripherer

RW,

tionelle

deposimac-

1987; P. Gruen

Perkutane

gefaesse.

Thelen

B,

rekanIn:

M, eds. New

T,

Interven-

York:

Thieme,

20-44.

Starck

J, Crummy

E, McDermott

nipseed

W,

neous

aspiration

Radiology 6.

AIR

W.

radiologie.

1988;

clot

T. Berliner

B, Krings

Guenther

5.

angioplasty.

Koppers

the and

1986;

Davis

eration

aspira-

catheter rotating

(in

eda-Zuniga

3.

D.

thrombembolectomy

propeller-tipped

Acher

IF,

kins

MC.

my

catheter.

Percuta-

thromboembolectomy.

1985;

Hawkins

A, Tur-

J.

C, Burgess 156:61-66.

Helms

R, Spencer

Mechanical

C, Haw-

spiral

Semin

embolecto-

Intervent

Radiol

1985;

2:414-418. 7.

Beck

A, Nanko

Erste

erfahrungen

N,

Blum

mit

U, Weiss

der

8.

CV

port 1988; 1:120-124. Bildsoe MC, Moradian

Castaneda-Zuniga

9.

10.

chanical

clot

diology

1989;

Kensey

RK,

WR,

Nash

with

flexible

new

JE,

concept.

Abrahams

Ra-

tip

catheter.

165:387-389. Dow R, McDaniel

Cost-effectiveness

C, Zarins

of obstructed

rotating

Arch

Re-

171:231-233.

Recanalization

bolysis.

World

GP, Hunter DW, Amplatz K. Me-

dissolution:

CK.

ogy 1987; Dacey U,

HW.

transfemoralen

aspirationsthrombektomie.

helped

artery.

and

(10)

U

tion

ro-

complications or embolic occlu-

embolization

money

References

may

tating propeller during low suction or that subintimal dissection will occur. Dissection did not occur in any of our cases. Our preliminary clinical results are encouraging. The system enabled quick and effective removal of thrombus material

rial may

success

lumen and allows a relaspace for thrombus aspiraobstruction by fibrin de-

winding

to aspiration and adherence of thrombotic material to the vascular wall may explain incomplete removal. Use of the device seems to be an effective alternative to local lysis therapy in fresh arte-

section

eventually occur after aspiration of larger amounts of clot material (1), but the wire can be easily exchanged. Furthermore, the small propeller keeps the catheter tip flexible, thus allowing insertion of the 7-F system in even smaller vessels such as the tibioperoneal arteries. Unlike the Kenscy catheter (9), the propeller tip does not extend beyond the guiding catheter while rotating, so that mechanical damage to the vascular wall is avoided. Since the nontapered catheter is placed in the long axis of the vessel and does not meet the vascular wall rectangularly, it is unlikely

to 45-cm-long introducer sheaths (6-9 F). Hawkins et al described a device that uses both a rotating and oscillating spiral

tion without aspiration (8). With their system, formed thrombi are disintegrated and allowed to embolize peripherally. Most of these devices are experimental, and, consequently, no sufficient clinical data are available to assess the clinical value of a single system. Mechanical thrombus fragmentation with our system is achieved by means of a catheter with a small propeller at the tip. From our experimental studies (1) we learned that the diameter of the inner channel is important for effective and rapid thrombus aspiration. The tiny propeller-tipped guide used for thrombus fragmentation causes only

MD,

of intra-arterial Surg

1988;

arteries Radio!et al. throm-

123:1218-1223.

Thrombus removal from the PTFE graft was also effective. In the venous systern, however, collapse of the vein due

Radiology

.

273