Kimihiko Kiyoshi Hajime
Kichikawa, Nishimine, Ohishi, MD
MD MD
#{149} Hideo
Uchida, Yasushi Kubota, #{149} Satoru Iwasaki, MD #{149}
MD MD
Iliac Artery Stenosis Results of Treatment Expandable Metallic Ten patients with atherosclerotic stenosis or occlusion of the iliac artery were treated with Gianturco cxpandable metallic stents. In the five cases of stenosis, only balloon dilation was performed prior to placement of stents. The five patients with occluded arteries were given intraarterial infusions of urokinase before balloon dilation and stent placement. Clinical symptoms improved in all patients, and no technical failures or complications occumred. Doppler ankle-brachial indcx studies were performed in nine cases, and in all nine cases the indexes improved after stent placement During follow-up of 2-18 months (mean, 10.3 months), all anteries remained patent. Follow-up angiograms showed slight intimal thickening and no restenosis. Longterm follow-up and more clinical experience will be necessary to evaluate the efficacy of this stent. However, preliminary results suggest that the Gianturco expandable metallic stent is of value in the treatment of arterial occlusive disease. Index
terms:
Arteries,
98.1299 #{149} Arteries, nosis or obstruction, minal angioplasty, 92.721, 98.721
Radiology
grafts
and prostheses,
iliac, 98.721 #{149} Arteries, ste98.721 #{149} Arteries, translu98.128 #{149} Arteriosclerosis,
1990; 177:799-802
P
Tetsuya
#{149}
#{149} Shoji
Yoshioka, Sakaguchi,
MD MD
and Occlusion: with Gianturco Stents’ ERCUTANEOUS
transluminal
its indications have been expanded by the combined use of intraarterial infusions of urokinase (2,3), laser angioplasty, andlor atherectomy cathe-
terization. However, at present, the long-term patency rate following PTA is not always satisfactory (4). Long-term patency is expected in cases with localized and concentric stenoses, while recurrence is frequent when long, irregular, ulcerated stenoses and occlusions, diabetes mellitus, present
or poor runoff (4). Currently,
vessels are new intravas-
the
clinical
use
of Gianturco
840 Shijo, Kashihara, Nara 634, Japan. Received March 7, 1990; revision requested April 24; revision dress C
received July reprint requests RSNA, 1990
30; accepted to K.K.
August
2. Ad-
PATIENTS
AND
METHODS
The study group consisted of 10 patients-nine men and one woman, ranging in age from 48 to 88 years (mean, 65.6 years)-with
chronic
atherosclerotic
rial stenosis and/or occlusion (Table). patients had symptoms of intermittent
Three
stenoses
and four oc-
clusions
were located in the common iliac artery, and one stenosis was located in the external iliac artery. Two patients had stenosis or occlusion of both the common and external iliac arteries. The length of the occlusions ranged from 3u/2 to 15 cm. The patient (case 3) with the external iliac artery stenosis had an additional 20-cm occlusion of the ipsilateral superficial femoral artery. Restenoses were noted 10 and 12 months after conventional PTA in cases 1 and 3, respectively. Informed consent was obtained from each patient, and
approval of the investigational protocol was obtained from our university before placement of stents. Five patients with
underwent
stenosis
balloon
before
stent
with
occlusion
after
stents for treatment of arterial obstructions, except for our initial meport of results (14). We inserted Giantunco expandable metallic stents into the iliac arteries of 10 patients to prevent restenosis after PTA. (The stents used-which are not commercially available-were made by ourselves, supported by Hirata Sangyo, Osaka, Japan.) The patients were followed up for 2-18 months. In this report, we present our initial and follow-up
MD
Preliminary
placement
cular stents are being developed to improve the immediate results and prognosis after PTA (5-9). Gianturco expandable metallic stents have been used clinically for treatment of obstructive lesions in the vena cava (10), tracheobronchial tree (1 1), and biliary tract (12,13), but, to our knowledge, no other reports have descnibed
Maeda,
claudication.
an-
gioplasty (PTA) has been advocated as a less invasive therapeutic method than surgical revasculanization for arterial occlusive disease (1). In recent years, the initial success rate of PTA has been improved and
results.
1 From the Departments of Radiology (K.K., H.U., T.Y., MM., Y.K., 5.5., 5.1.) and Oncoradiology (K.N., HO.), Nara Medical University,
Munehiro
#{149}
(cases
dilation
1-5)
immediately
placement. was
In three patients 6, 9, and 10), stent performed immediately
(cases
thrombolysis
Balloon
dilation
stainless
steel
and balloon
dilation.
and
stent placement were performed 8 and 13 days after thrombolysis in cases 7 and 8, respectively. Thrombolysis was performed with infusion of urokinase into the occluded lesion. The total dose of urokinase ranged from 300,000 to 1,020,000 IU (mean, 632,000 IU). Balloon dilation was performed with a 7-mm-diameter balloon. Stent placement was performed via the ipsilateral femoral artery. The stents were made of 0.01-inch (0.25-mm)-diameter
wire
bent
in a zigzag
con-
figuration containing six bends at each end. The diameter of the stent at full expansion was chosen to be about 1 .2 times that of the native iliac artery. We used 1.0-cm-diameter stents in nine cases and a 1.2-cm-diameter stent in one case (case 6). The length of the stent was 1 cm, and several stents were connected in tandem by metallic struts cut from the same wire. The stent was inserted so that the dilated segment was totally covered. We used three connected stents in cases 2, 4, 6, and 8 and five connected stents in cases 7 and 9. In cases 1 and 3, three connected stents and four connected stents overlapping by 0.5 cm were inserted. In case 5, four and
five connected
stents
were
inserted.
In
arte-
All
Abbreviation: minal
PTA
=
percutaneous
translu-
angioplasty.
799
Summary
of Cases An kle-Brachial Location of
Case
Age (y)
Sex
Lesion
1
55
M
CIA
2 3 4 5 6 8
48 65 70 59 69 53 71
M M M M M M M
CIA EIA CIA CIA, EIA CIA CIA CIA
9
88
F
10
78
M
7
Note-CIA
case
10, three,
four,
and
was
stents
(Cook,
inserted
were
five
across
No.
of
Before Stent
After Stent
Placement
Placement
At
Follow-up
Stents
Stenosis
NA
4 + 3
0.73
1.05
1.30
13
Stenosis Stenosis Stenosis Stenosis Occlusion Occlusion Occlusion
NA NA NA NA 5 10 3/2
3 4 + 3 3 5 + 4 3 5 3
0.93 0.46
1.17 0.81
1.21 0.79
4
Occlusion EIA
external
15 iliac
artery,
.
. .
Period
0.90 1.11 1.10 0.95
0.80 1.19 1.14 1.13
.
. .
.
Urokinase Dose (IU)
(mo)
14 11 10 4 18 13 10
. .
0.68 0.48 0.51 0.56
Follow-up
1,020,000 600,000 300,000
5
0.40
0.96
0.90
8
540,000
5 + 4 + 3
0.54
0.70
1.07
2
700,000
NA
not applicable.
connected Bloomington,
the
introduced
of
(cm)
Occlusion
EIA
iliac artery,
Length Occlusion
Lesion
CIA CIA,
common
=
stents were inserted. After a 7-F sheath
Ind)
Type of
Index
lesions,
at the
the
optimum
position with the cylinder of the 7-F sheath under fluoroscopic guidance with use of the road-map mode of digital subtraction angiography. The 7-F sheath was gradually removed, and the stents were expanded and fixed to the arterial wall. Immediately before balloon dilation and
stent
placement,
heparin
(50
lU/kg)
was injected during the of urokinase
through the catheter, and subsequent 3 days 120,000 IU was injected intravenously a day. Three patients were treated warfarin potassium (3 mg/d) and di-
twice
with
pyridamole
(300
cilostazol (200 and vasodilating tion
of these
mg/d)
mg/d), drug. drugs
and
Doppler
seven
with
an antithrombotic Oral administra-
was
least 6 months after Follow-up ranged (mean, 10.3 months). tions
and
continued
for
a. Figure nosis serted
are after
b.
c.
d.
1. Case 1. (a) Angiogram obtained 12 months with an ulceration is evident in the left common following balloon dilation in the stenotic lesion. marked with arrows and arrowheads, respectively.
stent
placement
at 5 months.
appeared.
Slight
shows intimal
The internal
good
patency
thickening
iliac
of the lesion.
over
artery-which
the
stents
after
conventional
PTA.
Recurrent
ste-
iliac artery. (b) Stents have been inProximal and distal ends of stunts (c) Angiogram obtained immediately
(d) Follow-up is evident,
is bridged
by the
c. 13 months
after
and stents-is
angiogram the
obtained
ulceration patent.
has
dis-
at
stent placement. from 2 to 18 months Clinical examinaankle-brachial
index
studies were performed every month, except in case 4. A plain radiograph of the pelvis was obtained at several days, 1 month, and 3 months after stent placement. Follow-up angiograms were obtamed in the seven patients who consented to the study.
RESULTS Stent placement was technically successful in all 10 cases, with improvement of clinical symptoms and elevation of the Doppler ankle-brachial indexes (Table). Angiograms obtained immediately after stent placement demonstrated no residual stenosis in all but one lesion (Figs 13). In an 88-year-old woman (case 9), five connected stents were placed in the incompletely dilated lesion after infusion of urokinase and balloon dilation. An angiogram obtained im-
mediately showed buried
800
after
stent
that the stents in the residual
Radiology
#{149}
placement were mural
partially clots,
a. Figure
2. Case
3.
b. (a) Angiogram
obtained
fibrinolysis
d. and
balloon
dilation.
Recurrent stenosis is seen in the right external iliac artery. (b) Three connected stents and four connected stents have been inserted into the lesion. Point of overlap is marked with arrow. (c) Angiogram obtained immediately after stent placement. Good patency is seen in the treated artery. (d) Follow-up angiogram obtained at 5 months. Slight neointimal thickening is evident.
which were continuous kinase (Fig Follow-up
completely lysed low-dose infusion 4). over 2-18 months
with a of urore-
vealed no occlusion or migration of stents, and all patients have been free of symptoms. The follow-up anklebnachial indexes did not change sig-
December
1990
a. Figure
b. 3. Case
c.
(a, b) Pelvic
7.
angiograms.
d.
Complete
e.
f.
occlusion
is evident in the left common iliac kinase infusion and balloon dilation. Recanalization of the common iliac artery has been achieved, portion is evident (arrow). (d) Five connected stents have been inserted. The curvilinear calcification the stents. (e) Proximal common iliac artery with localized irregular stenosis is dilated after insertion gram obtained at 7 months. The stenosis has completely disappeared, and good patency is evident. of the most distal stent.
artery. (c) Angiogram but irregular stenosis of the vessel wall of stents (arrow). Ulcerations (arrows)
patency (8). nent expansile
obtained after uroof the proximal is visualized along (f) Follow-up angioare seen at the level
Furthermore, the force prevents
recoil of the dilated The most important
permaelastic
vessel wall. problem
in
stent placement is early thrombotic occlusion and neointimal proliferation leading to late restenosis or occlusion. In case 9, the stent was
placed in an incompletely dilated tery and was buried in a residual ral thrombus immediately after placement. thrombotic balloon residual
For prevention of early occlusion, we performed dilation for elimination of stenosis and gave intraarteri-
a! fibrinolytic
a. Figure
b. 4. Case
9.
(a) Pelvic
c.
angiogram.
Complete
occlusion
is evident
in the left common
iliac artery. (b) Angiogram obtained after insertion of five connected stents following nase infusion and balloon dilation. Left iliac artery is patent, but luminal narrowing residual thrombus can be seen. (c) Additional urokinase infusion has lysed the mural bus, leading to good patency of the artery.
nificantly
compared
immediately (Table).
after Plain
with
stent
those
seen
placement
radiographs
of the
pel-
vis obtained several days after placement and several months after placement showed no migration of the stents. Follow-up angiograms showed full dilatation of the stents and no restenosis or occlusion. On follow-up angiograms, thin, unopacified layers that suggested neointimal thickening were seen between the stents and the opacified lumina. In case 1, the internal iliac arterywhich was bridged by the stent wire-was patent (Fig 1).
DISCUSSION Since Dotter of coil-shaped
Volume
177
first reported intravascular
Number
#{149}
3
the use stents
urokidue to throm-
various types of stents have been developed (16-22). Recently, clinical reports of the Palmaz stent and Wallstent device for treatment of arterial occlusive disease have been published (5-9). The Gianturco expandable metallic stent is a stainless steel wire bent in a zigzag configuration. This stent has such a high expansion ratio that it can be inserted through a relatively small sheath, as (15),
compared with Palmaz stents, and maintain a large diameter in the yessels. In our study, the stent could be easily inserted through a 7-F sheath for conventional angiography. Intravascular stent placement after balloon dilation reduces the pressure gradient and achieves a smooth sumface, which is one of the most important factors in maintaining long-term
tion stent nase days In timal
vere
ammu-
therapy
for elimina-
of the residual thrombus before placement. In addition, urokiwas injected intravenously for 3 after the procedure. animal experiments (23-25), inhyperplasia
luminal
has
not
narrowing
led
to se-
or occlusion.
However, in clinical reports of other types of stents (7,8), restenosis or reocclusion due to intimal hyperplasia has occurred. To keep intimal hyperplasia to a minimum, we selected a stent diameter that was about 1.2 times the diameter of the native iliac
artery,
based
et al (23).
wire (0.01
used inch
The
on the diameter
results
of Duprat
of the
stent
in this study was smaller [0.25 mm]) than that previ-
ously reported for the experimental use of this stent in arteries (16,23-25). On the basis of our results, we assume that 0.01-inch (0.25-mm)-diameter wire is suitable for maintenance of luminal patency after PTA. In the report of Palmaz et al (26), the amount of fibrin-platelet thrombus material deposited was proportional to the total metal surface of the stent. In this respect, the Gianturco stent has a small metallic surface area, which may reduce thrombogenicity
Radiology
801
#{149}
and the total amount rowing due to intimal experimental studies Gianturco bogenicity
stent even
showed without
of luminal hyperplasia. (16,24,25), low the
theless,
nanIn the
thromadmin-
istration of anticoagulant or antiplatelet drugs. However, the administration of anticoagulant or antiplatelet drugs should be continued for at least 6 months, until the stent is completely covered by neointima. Gunther et al (7) and Rousseau et al (8) describe how stent stenosis due to intimal hyperplasia can be treated with balloon dilation and atherectomy catheterization. This technique for treatment of intimal hyperplasia will expand the indications for stent placement and enhance long-term
ease.
pecially
where
into the peripheral that side branches remained patent, in experimental (7,8)
there
is good
occlusive
dis15.
BT, Dake MD.
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The Gianturco stent has a larger open surface area than other types of stents. When another stenosis of the bridged side branch develops after stent placement, it may be treated with balloon dilation via the side wall of the stent. This technique is probably more difficult in cases treated with other types of stents. In our study, no technical failures and no restenosis or reocclusion occurred. This report is based on experience with a small number of cases with an 18-month follow-up. More clinical experience and long-term follow-up will be required to evaluate the efficacy of this stent. Never-
of arterial
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#{149}
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#{149} Radiology
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1990