Abstracts

INTRODUCTION

Peripheral arterial occlusive disease is responsible for thousands of amputations in Brazil every year. In the United States, about 100,000 amputations a year are due to lower extremity atherosclerosis¹1. Hallet JW. Comprehensive vascular and endovascular surgery. 2nd ed. Mosby; 2009..

Chronic ischemia of lower limbs secondary to peripheral atherosclerotic disease may lead to intermittent claudication or critical ischemia, whose symptoms include rest pain and trophic lesion. Incidence increases with population age, as well as with risk factors, such as smoking, diabetes and hypercholesterolemia.

Patients with chronic lower limb ischemia have not only a high risk of limb amputation, but also higher morbidity and mortality rates due to ischemic heart and cerebrovascular diseases. Critical ischemia, which includes rest pain and tissue loss, is associated with an annual mortality rate of about 20%²2. Ouriel K. Peripheral arterial disease. Lancet. 2001;358:12571264. http://dx.doi.org/10.1016/S0140-6736(01)06351-6
http://dx.doi.org/10.1016/S0140-6736(01)... ^{, 3}3. Trans-atlantic Inter-Society Consensus Working Group. Management of pepipheral arterial disease. J Vasc Surg. 2007;45(suppl 5):55-567.. Seldinger, in 1953, Dotter, in 1964, Grutzing, in 1974, and Palmaz, in 1985, were the pioneers of minimally invasive procedures in vascular surgery. Since their time, new devices, such as guide wires, catheters, balloons and stents, have been developed for endovascular interventions every year⁴4. Seldinger S. Catheter placement of the needle in percutaneous arteriography: A New Technique. Acta Radiol. 1953;39:368. http://dx.doi.org/10.3109/00016925309136722
http://dx.doi.org/10.3109/00016925309136...

5. Dotter CT, Judkins M. Transluminal treatment of arteriosclerotic obstruction. Circulation. 1964;30:654-670. http://dx.doi.org/10.1161/01.CIR.30.5.654
http://dx.doi.org/10.1161/01.CIR.30.5.65...

6. Gruntzig A, Hopffh H. Perkutane rekanalisation chronischer arterieller verschlusse mit einem neven dilatationskatheter: modifikation der Dotter-technik. Dtsch Med Wochenschr. 1974;99:2502-2510. http://dx.doi.org/10.1055/s-0028-1108161
http://dx.doi.org/10.1055/s-0028-1108161... ^{- 7}7. Palmaz JC, Richter GM, Noldge G, Kauffmann GW, Wenz W. Intraluminal Palmaz stent implantation. The first clinical case report on balloon-expanded vascular prosthesis. Radiology. 1987;27:560-63..

The development of endovascular techniques to treat peripheral arterial diseases has enabled the use of minimally invasive methods and reduced morbidity and mortality in comparison with the rates obtained with conventional surgery.

In the region of the iliac artery, endovascular treatment has been associated with low morbidity and mortality when compared with open surgery. Procedures are performed under local anesthesia and percutaneously, which results in less surgical trauma to patients with multiple comorbidities. Patient recovery is rapid, and patency rates in the long term are comparable to those of open surgery.

OBJECTIVE

This study described and evaluated the results of a series of patients that underwent iliac artery angioplasty, as well as mid and long term results according to the following factors:

METHOD

From January 2004 to February 2010, 59 patients underwent endovascular interventions in the iliac artery. Data were collected retrospectively using a specific protocol presented to patients at the time of hospitalization. The protocol included data about patient age and sex, clinical severity of arterial disease (claudication, rest pain or tissue lesion), comorbidities and risk factors of atherosclerosis (smoking, diabetes, hypertension, dyslipidemia), laboratory tests and diagnostic procedures and vascular assessment. All patients signed an informed consent term at the time of hospitalization and granted permission for the performance of procedures. The consent term was the one used in the hospital where the patients underwent operation, approved by the Ethics Committee of the institutions where the study was conducted.

The patients underwent operations in two tertiary hospitals: a private hospital with 400 beds and a cardiovascular service; and a public hospital with 500 beds and a Residence Program in Vascular Surgery and a C-arm in the operating room for the performance of vascular interventions.

The procedures were performed under local anesthesia and sedation; the patients were hospitalized after angioplasty and discharged in the next morning. Antiplatelet therapy with 200 mg/day of acetylsalicylic acid (AAS) and 75 mg/day of clopidogrel was initiated three to five days before the intervention. The use of 75 mg/day of clopidogrel was continued for 30 days after the operation, combined with 200 mg/day of AAS. After 30 days, clopidogrel was discontinued, but AAS at 200 mg/day was maintained.

All 59 patients underwent postoperative follow-up, which included clinical examinations, ankle-brachial index measurements and a duplex ultrasound or CT angiogram at 30 days, 3 months, 6 months, 12 months, and every 6 months thereafter. Follow-up was performed by the author in the outpatient service of the public hospital and in his private office in the case of his private patients.

The protocol for data collection is shown in the supplementary annex (^{Annex 1} Annex 1 ).

Description of angioplasty technique

Vascular access

Access to the iliac artery was via retrograde ipsilateral puncture of the common femoral artery. Two techniques can be used for this puncture: puncture of the anterior wall of the artery only, using an arterial puncture needle; or use of a piercing technique and a Jelco 16G catheter.

In patients without a femoral pulse, techniques for puncturing without a pulse were adopted, always using a puncture needle⁸8. Moore WS, Ahn SS. Endovascular surgery. 3rd ed. Philadelphia: WBSaunders Company; 2001.:

Interventions in the aortic bifurcation

This technique was used in cases of bilateral ostial lesions of the common iliac arteries. The technique had the following steps⁹9. Schneider PA. Endovascular skills: guidewire and catheter skills for endovascular surgery. 3nd ed. Informa heathcare USA; 2009.:

Unilateral iliac lesion

In cases of unilateral iliac lesions, several techniques were used, as described below.

When the lesion is less than 2 cm from the aortic bifurcation, a contralateral puncture is also necessary.

Contralateral puncture may also be useful for angiographic control during the procedure.

Brachial access may also be used in case of occlusions, because the lesion may often be recanalized more easily; and, also, in cases of lesions of the external iliac arteries close to the inguinal ligament when there is not enough space to position the introducer. A pigtail catheter positioned via brachial access may also be used for angiographic control during the procedures. In any case, this access is used only in selected cases of iliac artery angioplasty.

Use of stents

Stents were used selectively according to indications:

• inadequate result of balloon angioplasty with extensive dissection or limiting flow, or with a pressure gradient greater than 11 mmHg;

• occlusions;

• ostial lesions; and

• calcified plaques or large ulcerations.

In ostial or calcified lesions, the balloon-expandable stent was used because of its greater radial force and more accurate release. When the lesion reached the common and external iliac arteries, or when the lesions were very long and in tortuous segments, self-expanding nitinol stents were used because of their marked flexibility.

Figures of cases in the series

Case 1

Patient with trophic lesion in fifth toe, stenosis of left common iliac artery and subocclusion of left external iliac artery treated with angioplasty and balloon-expandable stent in left common iliac artery and self-expanding stent in the distal third of the common iliac artery and external iliac artery (Figures 1a-c).

Case 2

Patient with disabling intermittent claudication and bilateral ostial stenosis of the common iliac artery. Treatment with a balloon-expanding kissing stent (Figures 2a-c).

Case 3

Patient had undergone stent angioplasty of left common iliac artery four years before and had in-stent restenosis and stenosis of renal artery. A neobifurcation was prepared with kissing stents and stent angioplasty of renal artery (Figures 3a-e).

Case 4

Patient with trophic lesion of left foot. Aortogram revealed total left common iliac artery occlusion and proximal ulcerated plaque in right common iliac artery. Treatment with balloon-expanding kissing stent (Figures 4a-d).

RESULTS

Mean patient age was 62 years (minimum: 42; maximum: 89); 37 were male patients (62.72%) (Figure 5).

The predominant risk factors were smoking, in 72% of the cases, and diabetes, in 30%.

The main treatment indications were limiting or disabling intermittent claudication in 30 cases (50.84%) and rest pain or trophic lesion (critical ischemia) in 29 cases (49.15%) (Figure 6).

Lesions were classified as TASC A in 39 cases (66.10%), TASC B in 13 (22.03 %), TASC C in two (3.38%) and TASC D in five (8.47%) (Figure 7).

Patients had stenosis in the iliac arteries in 42 cases (71.18% of the cases in the series) and occlusions in 17 cases (28.81% of the cases in the series).

Initial technical success was achieved in 56 cases (94.91%). Three were classified as technical failures: two had bilateral lesions, but recanalization of at least one side was achieved (partial technical failure). In one of the patients, with a TASC D lesion, there was no canalization in either side (treatment failure). He died on the 10th postoperative day due to complications of underlying diseases: chronic obstructive pulmonary disease (COPD), diabetes and sepsis.

The patients underwent postoperative follow-up, which included c ankle-brachial index measurements and a duplex ultrasound scan at 30 days, 3 months, 6 months, 12 months, and every 6 months thereafter. Minimum follow-up was three months, and maximum, 72 months (six years), and mean follow-up was 22 months. There was a small loss to follow-up, and it was not possible to calculate late survival.

During postoperative follow-up, there were:

• two occlusions (3.38%): one patient with occlusion at 12 months after the procedure was asymptomatic and was treated only clinically, without another intervention. Another patient had occlusion 30 days after the procedure and underwent aortobifemoral bypass;

• three restenosis occurred in the first 12 months after angioplasty (5.08%): two underwent another angioplasty, which was successful, and the other, aortobifemoral bypass because there were severe diffuse lesions of the common and external iliac arteries bilaterally; and

• a major amputation (iliac angioplasty followed by posterior distal femoral tibial bypass. Iliac angioplasty was patent, but the bypass occluded in the first week after operation, and the patient underwent amputation of the thigh).

These data show primary patency in 91.37% and secondary patency in 94.82% (Table 1).

A patient had more serious complications: perforation of leg artery in a combined infrapopliteal procedure that required postoperative fasciotomy due to compartment syndrome. The patient had chronic renal failure with hemodialysis and had a coagulation disorder, which contributed to the development of the compartment syndrome and the need to undergo fasciotomy. She recovered satisfactorily.

There were no pseudoaneurysms, retroperitoneal hematoma, arterial occlusions or need of blood transfusion.

There were two deaths in the first 30 days after operation (3.3% mortality) not associated with the angioplasty. A kidney transplant recipient, who was hospitalized with acute pancreatitis and developed acute ischemia of the right lower limb, required fibrinolysis and angioplasty of the common iliac artery and limb perfusion was restored. Ten days after the procedure, she died due to complications of acute pancreatitis (respiratory failure and sepsis). Another patient, with a TASC D lesion in which recanalization was not achieved, already described above, died due to COPD complications, diabetes and sepsis.

DISCUSSION

Although open surgery, particularly aortobifemoral bypass, apparently results in better patency in the long term than endovascular surgery in the aortoiliac region, the risks of open surgery are much higher than those of endovascular treatment, not only in terms of mortality, but also in regard to morbidity and patient return to usual daily activities. A meta-analysis of 25 studies about aortobifemoral bypass found 4.4% deaths and 12.2% complications, in addition to 91% patency at five years for patients with claudication and 87% for those with critical ischemia¹⁰10. Vries SO, Hununk MGM. Results of aortic bifurcation grafts for aortoiliac occlusive disease: a meta-analysis. J Vasc Surg. 1997 Oct;26(4):558-59. http://dx.doi.org/10.1016/S0741-5214(97)70053-3
http://dx.doi.org/10.1016/S0741-5214(97)... .

However, studies about the use of an endovascular approach showed that, in a series of 151 cases of angioplasty of the iliac arteries, there were no deaths and only one minor complication (inguinal hematoma), whereas assisted primary and secondary patency was 98% at seven years. Most lesions treated in this series were stenosis and TASC A or B lesions¹¹11. Kudo T, Chandra FA, Ahn S. Long-term uotcomes and predictors of iliac angioplasty with stenting. J Vasc Surg. 2005 Sep;42(3):466-75. http://dx.doi.org/10.1016/j.jvs.2005.05.002
http://dx.doi.org/10.1016/j.jvs.2005.05.... . Therefore, the approach for each patient should take into consideration general health and type of lesion.

In a retrospective study with 138 patients with iliac occlusions treated with angioplasty and stents, patency rates were 90%, 85%, 80% and 68% at three, five, seven and 10 years. According to the authors, an initial endovascular approach seems to be justifiable for most patients, particularly older patients and those with severe comorbidities, because it is less invasive than surgery¹²12. Gandini R, Fabiano S, Chiocchi M, Chiappa R, Simonetti G. Percutaneous treatment in iliac artery occlusion: long-term results. Cardiovasc Intervent Radiol. 2008 Nov-Dec;31(6):1069-76. http://dx.doi.org/10.1007/s00270-008-9386-5
http://dx.doi.org/10.1007/s00270-008-938... . Another retrospective study with 937 patients found 73% primary patency, 88% assisted primary patency and 90% secondary patency at 10 years, with mortality rates lower than 1%¹³13. Davies MG, Bismuth J, Saad WE, Naoum JJ, Peden EK, Lumsden AB. Outcomes of reintervention for recurrent disease after percutaneous iliac angioplasty and stenting. J Endovasc Ther. 2011 Apr;18(2):169-80. http://dx.doi.org/10.1583/10-3257.1
http://dx.doi.org/10.1583/10-3257.1... . Pedron et al.¹⁴14. Pedron C, Ristow AV, Cury-Filho JM, Martin HS, Peixoto CC, Fonseca LMB. Tratamento endovascular da oclusão das artérias ilíacas. Radiol Bras. 2001;34(5):261-265. http://dx.doi.org/10.1590/S0100-39842001000500004
http://dx.doi.org/10.1590/S0100-39842001... studied a series of 24 cases of iliac occlusion treated with angioplasty and found technical success rates of 91.7% and patency of 71% at 1 year¹⁴14. Pedron C, Ristow AV, Cury-Filho JM, Martin HS, Peixoto CC, Fonseca LMB. Tratamento endovascular da oclusão das artérias ilíacas. Radiol Bras. 2001;34(5):261-265. http://dx.doi.org/10.1590/S0100-39842001000500004
http://dx.doi.org/10.1590/S0100-39842001... . Moreira et al.¹⁵15. Moreira SM, Kambara AM, Ajzen S, Costa Junior JR. Quantificação volumétrica da hiperplasia neointimal em artérias ilíacas após implante de suporte intravascular metálico. Radiol Bras. 2009;42(4):231-234. http://dx.doi.org/10.1590/S0100-39842009000400008
http://dx.doi.org/10.1590/S0100-39842009... evaluated neointimal hyperplasia using intravascular ultrasound 8 months after the procedure in 30 patients that underwent angioplasty of the iliac arteries and stenting, and found that it was self-limited and did not lead to significant restenosis in any of the cases¹⁵15. Moreira SM, Kambara AM, Ajzen S, Costa Junior JR. Quantificação volumétrica da hiperplasia neointimal em artérias ilíacas após implante de suporte intravascular metálico. Radiol Bras. 2009;42(4):231-234. http://dx.doi.org/10.1590/S0100-39842009000400008
http://dx.doi.org/10.1590/S0100-39842009... .

In our study, most patients had TASC A or B lesions (88.13% of the cases) and stenosis (42 patients, or 71.18% of the cases), and primary (91%) and secondary (94%) patency rates were also high, whereas morbidity and mortality rates were low. These findings suggest that the endovascular approach should be the first treatment alternative in case of stenosis and TASC A and B lesions. If the endovascular treatment fails for a patient, there remains the option of undergoing another angioplasty procedure or attempting open surgery. Of the three patients with restenosis in our series, two underwent another angioplasty and one, open surgery, as shown in the results of postoperative follow-up. Of the two that had occlusion during follow-up, one underwent surgery, and the other was treated only clinically.

Initial technical and clinical success of angioplasty in the treatment of stenosis in iliac arteries is greater than 90% in practically all publications in the literature. This rate may reach almost 100% in the case of focal stenosis. In contrast, the success rate in the case of occlusions is about 85% and depends on fibrinolysis. The development of advanced materials and the availability of more advanced techniques have resulted in greater technical success when recanalizing occlusions¹⁶16. Saket RR, Rzavi MK, Padidar A, Kee ST, Sze DY, Dake MD. Novel intravascular ultrasound-guided method to create transluminal arterial communications: initial experience in peripheral occlusive disease and aortic dissection. J Endovasc Ther. 2004;11(3):274-280. http://dx.doi.org/10.1583/03-1133.1
http://dx.doi.org/10.1583/03-1133.1... .

Several recent studies have also confirmed the efficacy and safety of this method. A study with a series of 118 patients with occlusion of the iliac artery treated with primary stenting found a secondary patency of 93% at five years of follow-up¹⁷17. Ozkan U, Oguzkurt L, Tercan F. Technique, complication and long-term outcome for endovascular treatment of iliac artery oclusion. Cardiovasc Intervent Radiol. 2010 Feb;33(1):18-24. http://dx.doi.org/10.1007/s00270-009-9691-7.

However, the indications of interventions, be them open surgery or endovascular approach, have not changed. In the case of patients with claudication, they should be treated first clinically, with the indication of smoking cessation, walking, control of risk factors, use of antiplatelet drug, vasodilating drugs and statins. Invasive treatments are indicated in the following conditions, according to recommendations of the Brazilian Society of Angiology and Vascular Surgery¹⁸18. Sociedade Brasileira de Angiologia e Cirurgia Vascular - SBACV. Diretrizes SBACV. J Vasc Br. 2005;4..

• limiting claudication;

• disabling claudication;

• no improvement with clinical treatment;

• rest pain; and

• trophic lesion.

In the series of patients in this study, these criteria were used to indicate interventions. The decision about invasive treatment for patients with claudication should also be made based on the individual context of each patient. Age, social life, fitness and professional status should be taken into consideration, and the simple application of only a rigid classification system should be avoided. In some specific cases, patients with moderate to severe claudication may become candidates for invasive treatment. Quality of life questionnaires may be used to decide whether or not an invasive procedure should be used and to select patients that will have the greatest benefit from that type of intervention¹⁹19. Aquarius AE, Denolet J, Hamming JF, Breek JC, De Vries J. Impaired heath status and invasive treatment in peripheral arterial disease: a prospective 1-year follow-up study. J Vasc Surg. 2005;41:436-42.. Angioplasty may improve the quality of life of patients with claudication when compared with clinical treatment and physical exercises alone²⁰20. Greenhalgh RM, Belch JJ, Brown LC. The adjuvant benefit of angioplasty in patients with mild to moderate intermitent claudication managed by supervised exercise, smoking cessation advice and best medical therapy: results from two randomised trials for stenotic femoropopliteal and aortoiliac disease. Eur J Vasc Endovasc Surg. 2008 Dec;36(6):680-8. http://dx.doi.org/10.1016/j.ejvs.2008.10.007
http://dx.doi.org/10.1016/j.ejvs.2008.10... .

The decision about a selective or routine use of stenting to treat iliac arteries remains controversial²¹21. Casserly IP, Sachar R, Yadav JS. Manual of peripheral vascular intervention. Lippincott Williams e Wilkins; 2005.. The Dutch Iliac Stent Trial (DIST) conducted a prospective and randomized comparative study of selective and routine stenting of 279 patients with claudication, and found similar results in both groups, without statistically significant differences²²22. Tetteroo E, Van der Graaf Y, Bosch JL. Randomised comparison of primary stent placement versus primary angioplasty followed by selective stent placement in patients with iliac-artery occlusive disease. Dutch Iliac Stent Trial Study Group. Lancet. 1998;351:1153-1159. http://dx.doi.org/10.1016/S0140-6736(97)09508-1
http://dx.doi.org/10.1016/S0140-6736(97)... . However, a meta-analysis comparing six studies with 1,300 patients that underwent angioplasty of the iliac artery without stenting and eight studies with 816 patients that underwent stenting suggested that the use of stents seems to bring immediate success and better long term results²³23. Bosch JL, Hunink MG. Meta-analysis of the results of percutaneous transluminal angioplasty and stent placement for aorto-iliac occlusive disease. Radiology. 1997;204:87-96.. Another study with a series of patients investigated the use of routine stenting in 90 lesions of the external iliac artery in patients with claudication and found that primary and secondary patency rates were 84% and 93% at three years of follow-up²⁴24. Maurel B, Lancelevee J, Jacobi D, Bleuet F, Martinez R, Lermusiaux P. Endovascular treatment of external iliac artery stenoses for claudication with sistematic stenting. Ann Vasc Surg. 2009 Nov-Dec;23(6):722-8. http://dx.doi.org/10.1016/j.avsg.2008.05.019
http://dx.doi.org/10.1016/j.avsg.2008.05... .

In our sample, we chose to use stenting selectively in the cases of unsatisfactory results of angioplasty, ostial or calcified lesions or presence of ulcerated plaque. Stents were also used routinely in cases of occlusion.

CONCLUSIONS

According to studies in the literature, angioplasty in iliac arteries is currently accepted as the method of choice for the treatment of lesions in this anatomic site, particularly because of its low morbidity and mortality rates and its good long term results.

Findings in this study showed that:

• the primary patency rate for angioplasty in the iliac arteries was 91.3%;

• the secondary patency rate for angioplasty in the iliac arteries was 94.82%;

• the rate of mortality in the first 30 days after operation was 3.3%;

• the rates of complications associated with the procedure were low (1 case of arterial perforation); and

• the rate of amputations was low (1 case in the series).

Endovascular treatment is an efficacious, long-lasting and safe option for the treatment of peripheral occlusive arterial disease in iliac arteries, particularly TASC A and B lesions with low complication rates and high patency rates, as demonstrated in this study, in which most lesions that underwent treatment received that classification.

Angioplasty in iliac arteries is a low-risk, low-mortality procedures with patency results that compare with those achieved when conventional surgery is used.

REFERENCES

Annex 1

Publication Dates

History