Percutaneous Transluminal Aortic Angioplasty: Techniques and Results

Cardiovasc lntervent Radiol ~1993) 16:37-42

CardioVascular and]nter onal

Radio y

9 Springer-Verlag New York Inc. 1993

Percutaneous Transluminal Aortic Angioplasty: Early and Late Results B e n y a m i n a Morag, ~ A l e x a n d e r G a r n i e k , LA,'ie Bass, 2 J a c o b Schnciderman,-" R a p h a e l W a l d e n , 2 a n d Z a l l m a n J. R u b i n s t e i n ~ Division of Angiography and [nterventional Radiology. Departments of ~Radiology and :Vascular Surgery, The Chaim Sheba Medical Center. TeI-Hashomer and Sackler School of Medicine, TeI-Aviv University, Israel

Abstract. P e r c u t a n e o u s t r a n s l u m i n a l a n g i o p l a s t y of" the i n f r a r e n a l a b d o m i n a l aorta (13 patients) and its bifi.lrcation (15 patients) ,,',as p e r f o r m e d in 28 patients with a total of 32 dilatation p r o c e d u r e s . The g r o u p c o n s i s t e d of 16 female and 12 male patients and initial s u c c e s s f u l dilatation was a c h i e v e d in all. R e c u r r e n c e within 1 m o n t h requiring b y p a s s surgery o c c u r r e d in I patient. T h r e e patients were lost to follow-up. L o n g - t e r m follow-up in the r e m a i n i n g 24 p a t i e n t s ranged from I to 9 years with a m e a n of 4.5 years. D u r i n g the follow-up period, repeat angio p l a s t y of the original s t e n o s i s was p e r f o r m e d in 3 p a t i e n t s a n d a n o t h e r patient u n d e r w e n t dilatation of a n e w lesion which d e v e l o p e d in the aorta. A c c o r d ing to clinical and n o n i n v a s i v e studies, these 4 patients, as well as the o t h e r 20. have m a i n t a i n e d pat e n c y of the treated lesions and arc s y m p t o m free. No i m m e d i a t e c o m p l i c a t i o n s requiring surgery occ u r r e d . We c o n c l u d e that a n g i o p l a s t y is the initial t r e a t m e n t o f choice in focal lesions of the distal abd o m i n a l a o r t a and its b i f u r c a t i o n .

specifically with p e r c u t a n e o u s t r a n s l u m i n a l aortic a n g i o p l a s t y ( P T A A ) are s p o r a d i c and c o n t a i n relatively small n u m b e r s of p a t i e n t s [7-13]. R e c e n t l y . reports of larger series have b e g u n to a p p e a r , with follow-up p e r i o d s a v e r a g i n g fi-om 25 to 33 m o n t h s [14-17]. Most series m e n t i o n that the aortic patholo,,y~ o c c u r s in relatively youn~z~female patients, usually h e a v y s m o k e r s , and in w h o m the aorta is hypoplastic [12, 13, 18-20]. The age and sex d i s t r i b u t i o n in the p r e s e n t series differs s o m e w h a t fl'om those reported by o t h e r authors. O u r initial e x p e r i e n c e with 14 p a t i e n t s was p r e s e n t e d in 1987 [11]. We n o w p r e s e n t the results in 28 treated p a t i e n t s with special e m p h a s i s on the l o n g - t e r m f o l l o w - u p which a v e r a g e s 54 m o n t h s . Inc l u d i n g repeat p r o c e d u r e s , a total of 32 dilatations were p e r f o r m e d .

Key words: A o r t a , t r a n s l u m i n a l a n g i o p l a s t y - - A r t e r ies, s t e n o s i s

Between 1981 and 1990. 28 patients underwent PTAA. The age and sex distributions of the patients are sho',vn in 'l'akqe I. All the 16 female and 6 of the male patients were heavy smokers. Diabetes mellitus was present in I female and 2 mate patients and hypertension 'aas noted in 2 male patients only. All patients had bilateral Iov.,erlimb elaudication, with 1female and 4 males having rest pain. Diagnostic angiography was performed either via axillarv or the translumbar route. In 13 patients the site of stenosis was in the distal abdominal aorta between the level of the renal arteries and the bifurcation IFig. I). and in the other 15 the aortic bifurcation was involved IFig. 2). Isolated proximal iliac artery stenoses were not included in this series. There was no male/female difference regarding the site of stenosis. The size of the uninvolved segment of the aorta ranged from II to 18 mm. Although not statistically proven, the female patients tended to have small aortic diameters. Associated distal disease in the iliac, femoral, or popliteal arteries was present in 7 of the 12 male~, and only 3 of the 16 female patients ~Table 2). For PTAA. the double balloon technique was used in all the

P e r c u t a n e o u s t r a n s l u m i n a l a n g i o p l a s t y (PTA) of peripheral v a s c u l a r d i s e a s e has b e e n e x t e n s i v e l y rep o r t e d , with a large series o f cases r u n n i n g into the h u n d r e d s . In the iliac, femoral, and popliteal areas, l o n g - t e r m follow-up studies have r e p o r t e d satisfactory overall results [1-6]. H o w e v e r , r e p o r t s dealing Address reprint requests to: Benyamina Morag. M.D., Division

of Angiography and Interventional Radiology, Department of Radiology. The Chaim Sheba Medical Center, Tel-Hashomer, Israel 52621

Material and Methods

38

B. blorag et al.: Percutaneous T r a n s l u m i n a l Aortic A n g i o p l a s t y

Fig. 1. A 40-year-old female p a u e n t with severe bilateral claudication at 100 m. A Severe aortic stenosis at the L,4 level imme~ diately proximal to the bifurcation with a sy~,tolic p r e s s u r e gradient of 90 m m Hg. B Double balloon dilatation. C Po,~tdilatation aortogram. No residual pressure gradient. D Second aortic stenotic lesion appearing 3 years htter at t h e L3 levet with a pressure gradient of 70 m m Hg. The original angioplasty site r e m a i n s well patent. E After dilatation of the s e c o n d stenotic lesion. No residual p r e s s u r e gradient. Patient had remained a s y m p t o m a t i c for the 5 years since follow-up angioplasty.

Table 1. Patient statistics Age 30-50 51-60 61-80 Total

Table 2. Incidence oF distal disease Male

Female

2 6 4 12

l0 4 2 1"-6

bifurcation lesions and in 7 of the aortic stenoses ~,Fig. 3~, before the introduction of large balloons [9, 1 I 1. Since then. the remaining 6 patients with aortic lesions have been treated with a single balloon (Fig. I). The balloon size was calculated according to the vessel diameter m e a s u r e d on the diagnostic angiogram, with 12-ram balloons being the largest used in the aorta. In order to avoid overstretching, the chosen balloon diameter was I-2 mm less than the width of the aorta above and below the stenosis.

Age 30-50 51-60 61-80 Total

Male 1 3 :~ 7

Female 1 I I 3

Ba!loon inflation was discontinued w h e n e v e r the patient noted abdominal or back pain. The length of t h e balloons used depended on the length of the stenotic s e g m e n t (Fig. 2). Angioplasty was performed via the transfemoral a p p r o a c h in all patients. Systolic, diastolic, and mean arterial pressures were recorded proximal and dista! to the tesions before and after the dilatations, with post-PTAA angiography being p e r f o r m e d at the end of the procedure. The main parameter in a s s e s s i n g the result of dilata-

B. Morag et al.: Pereutaneous Transluminal Aortic Angioplasty

39

Fig. 2. A 38-year-old female patient with buttock and thigh claudication at 50 m. A Aortic bifurcation stenosis. Pressure gradient was 60 m m Hg bilaterally. B Double balloon dilatation using balloons of the same size. C Postdilatation a o r t o g r a m Pressure gradient had completely db, appeared.

tion was the disappearance of the systolic pressure gradient or its drop to below 10 mm Hg. Heparin 5000 U was administered intraarteriaily dr, ring the procedure. Aspirin 500 mg or dip.vrMamole 75 mg daily were adminislered empirically for an indefinite period after the procedure. Folk>w-up was by clinical examination, ankle-arm indices. and Doppler studies at 3 - 6 month intervals. The state o r t h e femoral pulses was of special importance in assessing the continued patency of the aorto-il[ac segment in patients who had asst;,ciated distal arterial disease. The criteria .suggested by the Society for Vascular Surgery {SVS) were u~,ed in assessing long-term follow-up of the 28 patients [21].

Results

Initial Technical ResMts Technically successful dilatation was achieved initially in 27 of the 28 patients; the remaining patient developed an occlusion of the right common iliac artery at the end of the procedure which cleared completely after 24 h intraarterial streptokinase infusion. Before the procedure, the systolic pressure gradient across the stenosis ranged from 40 to 1 I0 mm Hg, with a mean of 60 mm Hg. After PTAA this gradient dropped to below l0 mm Hg in all except 2 patients. In one of the two it dropped from 50 to 20 mm Hg, but despite this residual gradient, good femoral pulses appeared. The other patient developed c o m m o n iliac artery occlusion at the end of the procedure which was immediately treated by intraarterial thrombolysis. Because of the occlusion,

no pressure could be measured distal to the PFA site. The post-PTAA angiographic picture showed dilatation of the stenosis in all patients. Almost all showed intimal tearing and irregularity.

C~mplk'atiop~s In addition to the already-mentioned patient with iliac artery thrombosis, which was successfully treated by thrombolysis, we encountered one distal embolus that resolved after a course of systemic heparin infusion. There were two instances of small inguinal hematoma formation, which did not require treatment. No other complications occurred in the entire se,-ies.

Long-term Paten('y Rate (Table 3) Three patients were lost to follow-up after their discharge from the hospital and 1 other developed restenosis within a month and underwent bypass surgery. Follow-up of the other 24 patients ranged from 1 to 9 years with a mean of 4.5 years. In 20 patients the treated aortic lesion remained patent without any additional procedure for the following periods of time: 6-9 years in 7 patients, t - 6 years in the other 13. Complete disappearance of claudication occurred in 15; in 3 others, rest pain was relieved and mild claudication (category 1) remained. In the 2 other patients, severe claudication (category 3) was con-

40

B. Morag et al.: Percutaneous Transluminal Aortic Angioplasty

Fig. 3. A 62-year-old male patient with rest pain. A Eccentric distal aortic stenosis with additiona} left common iliac artery stenosis. The pressure gradient v,as 100 mm Hg bilaterally. B Double balloon dilatations with a longer 10-cm balloon w:,s used on the left side. C Postdilatation angiogram. Pressure gradient was reduced to 5 mm Hg alter peripheral vasodilatation.

Discussion

verted to mild (category 1). All 5 patients who retained mild claudication had associated peripheral disease. In the 15 totally a s y m p t o m a t i e patients, ankle-arm indices rose by an average of 0.30 to above 1.00. In the 5 patients with associated distal disease, normal femoral pulses were present in all, but their ankle-arm indices averaged 0.8 as compared with 0.6 before the procedure. Repeat angioplasty was performed in 4 patients during the follow-up period. One developed a second site of stenosis in the aorta 3 years after the initial dilatation and the original treated stenosis remained dilated (Fig. 1). Since the second PTAA 5 years ago the patient has remained s y m p t o m free. Restenosis at the site of the original dilatation occurred in the other 3 patients 2 years after the original angioplasty. These 3 patients had all undergone dilatation of aortic bifurcation lesions and the restenosis occurred on one side of the bifurcation in each of them. They were all redilated and have since remained patent and s y m p t o m free with good femoral pulses for 2, 4, and 6 years, respectively.

Prior to the introduction of percutaneous angioplasty, the only treatment available to patients with abdominal aortic stenoses wets surgical bypass grafting or e n d a r t e r e c t o m y . P T A A now offers a safe and effective alternative to surgery. For angioplasty to be acceptable, its results should be at least as good as surgery and its morbidity and mortality lower. According to m a n y reported series, the initial patency rate after aorto-femoral bypass surgery ranges from 90 to 100% [22-26]. Long-term followup shows patency rates of 8 0 - 9 0 % at 5 years and 65-80% after 10 years [22-26]. The perioperative mortality of surgery ranges f r o m I to 5%, with morbidity reaching 27% in some series [24-26]. Late complications related to these grafts (except occlusion) have been reported in 2.4-6.8% of patients [26-29]. Patients requiring repeat surgery have even higher morbidity and mortality rates [30]. Angioplasty as an alternative or c o m p l e m e n t to surgery is ah'eady a well-established procedure in treating peripheral vascular disease [31]. PTAA of the infrarenal aorta has only recently been reported in significant numbers [13-17]. The fear of aortic rupture has not been substantiated, and initial success rates of about 95% have b e e n reported in most series [7-17, 32]. The morbidity and mortality have been low, with most complications being treatable by conservative means only. Aortic rupture has been

B. Morag et al.: Percutaneous Transluminal Aortic Angioplasty

4t

"Fable 3. Long-term results by life ruble analysis of 32 angioplasty procedures in 28 patients Interval (months}

No. patients

End of follow-up

No. tailed

0-1

32

3

I

1- 12

28

5

1

""~_ 17 13 l0 8 5 3 1

4 2 3 2 3 2 2 I

1 2 -------

1"~_-~.'4 24-36 36-48 48-60 6(I-72 72-84 84-96 96-108

reported in only I patient in whom a calcified plaque causing stenosis was dilated using 2 x 8-ram balloons simultaneously [32]. The present series, which encountered no serious complications requiring surgery, confirms the low complication rate. Only 1 patient needed bypass surgery due to early recurrence and the operation was not compromised by the previous PTAA. Our series differs slightly from many others irt that we had a higher proportion of male patients. The clinical features of the female patients were in keeping with other reported series in that they were young, all were heavy smokers, and their aortic diameters tended to be smaller [12, 13, 16, 18-20]. The male patients were older and more prone to associated distal arterial disease. The results of the aortic dilatation were equally good in both male and female patients, with those who had localized aortic lesions becoming completely asymptomatic. Some of those with peripheral disease became asymptomatic and the others improved significantly. Additional treatment for distal disease was instituted when necessary, but details of these treatments have not been included in this report. In our institution, all patients with suspected aortic or lilac disease have initial diagnostic arteriography performed via the translumbar or occasionally by the axillary route. This allows clear and unimpeded visualization of the aortic bifurcation, and the best approach to the angioplasty procedure is planned on the basis of the angiographic findings. This method did not raise our complication rate and we still prefer translumbar aortography as the initial diagnostic procedure of choice in elective peripheral vascular assessment. All patients with bifurcation lesions were treated by the double balloon technique via bilateral femoral punctures. This allowed for various combinations of balloon sizes, and the simultaneous inflation prevented inadvertent compromise of the contralateral

Interval patency rate

Cumulative patency rate

0.96 I).96 0.95 0.88 1 1 I I I 1

96.88 93.42 89.17 78.68 78.68 78.68 78.68 78.68 78.68 78.68

Standard error (%1 3.08 4,51

5.98 8.74 8.74 8.74 8.74 8.74 8.74 8.74

side, In aortic lesions either a single large balloon or double "kissing" balloons were used. The size of the balloon selected was always 1 or 2 mm less than the aortic diameter above and below the lesion in order to avoid overstretching of the wall. In assessing the efficacy of dilatation during the procedure, we relied mainly on the pressure gradient measurements. Ideally, complete disappearance of" the gradient should be achieved, but a residual gradient of up to 10 mm Hg in the presence of good femoral pulses was regarded as acceptable. The long-term follow-up oF out" series of patients is highly encouraging. Even those patients who returned with restenoses were successfully treated by repeat angioplasty. The high patency rate of the whole group averaging 4.5 years, with the longest of 9 years, suggests that the results of PTAA will equal or surpass those achieved for lilac artery dilatation. Restenosis developing after PTAA can be treated by repeat dilatation without adding to the complication rate such as occurs in repeat surgery. Another advantage of PTAA over surgery in males is the avoidante of neurogenic impotence that may result after surgical dissection in the region of the distal aorta and its bifurcation [33-35]. In conclusion, we believe that because of the good short- and long-term results as well as its safety, availability, and cost-effectiveness, PTAA should be the initial procedure of choice in all instances of distal aortic stenoses. The role ofintravascular stents in these patients is still to be assessed. In view of the good results with PTAA, including repeat procedures, stents may be reserved for selected, complicated procedures. References

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B. Morag et al.: Percutaneous Translumimfl Aortic Angioplasty

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