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Results of endovascular therapy and aortobifemoral grafting for Transatlantic Inter-Society type C and D aortoiliac occlusive disease
Results of endovascular therapy and aortobifemoral grafting for Transatlantic Inter-Society type C and D aortoiliac occlusive disease Sachinder Singh Hans, MD,a,b Debbie DeSantis, APRN, BC,a Rizwan Siddiqui, MD,b and Michael Khoury, MD,a,b Clinton Township, Mich, and Warren, Mich
Objective. The purpose of this study was to compare the outcomes of aortoiliac stenting (AIS) to those of aortobifemoral grafting (ABF) for patients with TransAtlantic Inter-Society Consensus (TASCII) C and D aortoiliac occlusive disease. Methods. From 1998 to 2007, 32 patients underwent ABF and 40 patients underwent AIS. KaplanMeier estimates for patency were used. Results. Patients undergoing AIS were older (66.6 years ABF vs 59.2 years AIS; P=.006). The ABF group had simultaneous profundoplasty (n = 8) and femoral-popliteal graft (n = 1). Six patients had treatment for concomitant infrainguinal disease at the time of AIS. There was no mortality in either group. Average hospital stay in the ABF group was 7 ± 2 days and 1 ± 0.3 days for AIS (P = .0001). Pulmonary complications predominated in the ABF group (13%). Four patients in the AIS group (10%) developed intraprocedural complications. Primary patency at 48 months was 69 ± .12% for AIS and 93 ± .07% for ABF (P = .013). There was a significant increase in ankle-brachial indices after revascularization in both groups. Conclusions. TASC type C and D lesions can be treated with either ABF or AIS with satisfactory results. Compared with ABF, AIS is associated with decreased primary patency, decreased perioperative morbidity, and shorter hospital stay. (Surgery 2008;144:583-90.) From the Henry Ford Macomb Hospital,a Clinton Township; and the St John Macomb Hospital, Section of Vascular Surgery and Vascular Intervention,b Warren, Mich
THE MANAGEMENT OF AORTOILIAC OCCLUSIVE DISEASE has undergone considerable evolution during the past 2 decades, primarily owing to the advent of balloon angioplasty and stent technology.1-15 The publication of the TransAtlantic Inter-Society Consensus (TASC) statement (2000) allows stratification of peripheral artery occlusive disease by lesion morphology.16 Recently, a new Consensus document (2007) with broader international presentation focusing on key aspects of diagnosis and treatment of lower extremity arterial occlusive disease was published.17 According to the TASCII classification of
Presented at the 65th Annual Meeting of the Central Surgical Association, Cincinnati, Ohio, March 6–8, 2008. Accepted for publication June 26, 2008. Reprint requests: Sachinder Singh Hans, MD, St John Macomb Hospital, Department of Surgery, 28411 Hoover, Warren, MI 48093. E-mail: [email protected]. 0039-6060/$ - see front matter Ó 2008 Mosby, Inc. All rights reserved. doi:10.1016/j.surg.2008.06.021
aortoiliac occlusive disease, lesions can be classified into categories A, B, C, or D with type A representing short, segmental stenosis of the common or external iliac artery. The lesions increase in complexity from type B, then to type C, and finally with type D representing long segment occlusions of the common and external iliac artery.17 As per recommendations of the TASC panel, endovascular therapy is the preferred method of treatment for type A lesions. Surgery is preferred for type D lesions.17 Some patients with type B and C lesions can be managed by either surgery or endovascular therapy, depending on the patient’s informed choice, medical comorbidities, and the experience level of the interventionist/surgeon.17 Recent device development to cross chronic total occlusions and rising experience levels among interventionists has increased the utilization of endovascular therapy for complex aortoiliac lesions.15,17 The purpose of this study was to compare the outcomes and durability of aortoiliac stenting (AIS) to those of aortobifemoral bypass grafting (ABF) for TASC types C and D aortoiliac occlusive disease. SURGERY 583
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PATIENTS AND METHODS Between 1998 and December 2007, 312 patients underwent arteriography for symptomatic aortoiliac occlusive disease. Two hundred twenty-eight patients underwent iliac angioplasty for TASC type A and B lesions. Eighty-four patients had treatment for TASC type C and D lesions. Endovascular treatment was attempted in 42 patients and successful in 40 patients. ABF was performed in 32 patients. Three patients underwent axillofemoral grafting, 7 underwent iliofemoral/crossover femoral-femoral grafting, and 2 patients refused intervention. The study was approved by the institutional review boards of both hospitals. The senior author (SSH) performed all ABF graft procedures and the majority of AIS procedures (28 out of 40). Clinical interventional and operative and postoperative data were obtained from the hospital and physicians’ office records. The data were kept in an ongoing vascular registry on a continuous basis. Preoperative demographic data, risk factors for atherosclerosis, and clinical symptoms were studied. Symptoms of lower extremity ischemia were classified into intermittent claudication or critical limb ischemia, later consisting of ischemic rest pain, ischemic ulceration, or gangrene of the toes. Endovascular procedures were performed in either the interventional radiology or cardiac catheterization laboratories using a fixed fluoroscopic unit. Two patients with TASC type C and D lesions underwent iliac stenting with simultaneous femoral endarterectomy as well as a distal bypass in the operating room using a portable OEC9800 unit (General Electric, Fairfield, Conn). All endovascular procedures were performed under systemic heparinization with pre- and postinterventional administration of antiplatelet medication (aspirin and clopidogrel). After undergoing a clinical examination and a noninvasive arterial evaluation, the patients underwent arteriography via femoral artery approach, with the subsequent passage of a hydrophilic wire (in some cases, Magic Torque; Boston Scientific, Natick, Mass). The passage of the wire was intraluminal or subintimal (intraplaque) in some patients with total occlusions. Bilateral femoral puncture was performed in 23 patients, unilateral femoral puncture in 14, and a combined femoral/brachial artery approach in 3. Associated common femoral atherectomy was performed in 1 patient and common femoral balloon angioplasty was performed in 2. One patient underwent a simultaneous common femoral artery endarterectomy, another underwent a common femoral endarterectomy and femoral-infrapopliteal
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(vein) bypass in the operating room, after iliac angioplasty and stent placement. All patients had a prestent angioplasty followed by stent placement and a poststent angioplasty. In general, 8.0- to 10.0-mm balloons were used for common iliac arteries, and 6.0- to 8.0-mm balloons for external iliac arteries for poststent angioplasty. Stents were placed bilaterally in 24 patients (48 limbs), in the right common and external iliac arteries in 6 limbs, and in the left common and external iliac arteries in 10 limbs. A total of 101 stents were deployed including 1 covered stent (FLUENCY; Bard Peripheral Vascular, Tempe, Ariz). Self-expanding Nitinol (SMART stent; Cordis, Johnson & Johnson, Cincinnati, Ohio) and, more recently, Prote´ge´ (EV3; Plymouth, Minn) were used predominantly. Balloon-extendable stents were used for the distal abdominal aorta and at the origin of the common iliac artery. In patients with a chronic total occlusion of the iliac artery, Frontrunner catheter (Cordis, Johnson & Johnson) were used in 4 patients and OUTBACK LTD catheter (Cordis, Johnson & Johnson) was used in 2 patients. A Pioneer intravascular ultrasound catheter (Medtronic, Indianapolis, Ind) was used to traverse chronic occlusion in 1 patient. A GOOSE NECK snare (EV3) was used to retrieve guide wires in 4 patients. In 1 patient, intravascular ultrasound was used to assist in the angioplasty/stent placement. Closure devices were infrequently used in this series. ABF procedures were performed in the operating room under general anesthesia via a transperitoneal approach in all patients. Follow-up was obtained in all patients with the exception of 2 in the ABF group (mean follow-up, 31.9 ± 33.9 months). All patients underwent clinical evaluation and a noninvasive Doppler arterial study (including toe pressures and ankle-brachial indices) at 1 month, 3 months, and 1 year, followed by a biannual or annual follow-up. Patency was assessed by clinical examination and noninvasive Doppler arterial study. Patients developing recurrent ischemic symptoms or positive noninvasive study results underwent conventional digital subtraction arteriography, magnetic resonance angiography, or computed tomographic angiography. Statistical methods. Data were analyzed using SPSS for Windows V15.0 (SPSS, Inc., Chicago, Ill). Kaplan-Meier survival analysis was used to examine primary and secondary patency and limb survival. Paired sample t-tests were used to compare the preand post-ABI values in both groups (endovascular procedures and surgical bypass procedures were grouped separately).
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RESULTS Thirty-two patients (64 limbs) underwent ABF and 40 patients (68 limbs) underwent AIS. In the AIS group, 27 patients had TASC type C lesions and 13 had TASC type D lesions. In the ABF group, 19 patients had TASC C lesions and 13 patients had TASC D lesions. There was no difference between the relative number of TASC C and D lesions in AIS and ABF group (P = NS). Procedures were technically successful in 40 out of 42 patients in the AIS group (95%), and in all patients in the ABF group. Symptoms displayed by patients undergoing AIS (n = 40), included intermittent claudication (n = 32), rest pain (n = 4), and ulceration/ gangrene of the toes (n = 4). Patients undergoing ABF (n = 32) presented with intermittent claudication (n = 25), rest pain (n = 3), and gangrene/ulceration of the toes (n = 4). Patients undergoing ABF had a mean age of 59.2 ± 7.4 years; patients undergoing AIS were older (66.6 ± 11.8 years; P = .006). Other demographic and clinical variables were similar in both groups, excluding incidence of smoking, which was higher in the ABF group (Table). Proximal anastomosis was end-to-end in the majority of patients (30 out of 32), and end-toside in 2 patients. In the majority of patients (n = 22), 16.0 3 8.0 mm knitted Dacron grafts were used; 14.0 3 7.0 mm grafts were used in 8 patients, and 18.0 3 9.0 mm grafts were used in 2. Patients in the ABF group underwent concomitant profundoplasty (n = 8) and femoral-popliteal graft (n = 1). Aorto right lower pole renal artery bypass was performed in 1 patient. The average hospital stay in the ABF group was 7 ± 2 days compared with 1 ± 0.3 days in the AIS group (P = .0001). Complications. There was no perioperative mortality in either group. Aortobifemoral group: Postoperative pulmonary complications in the form of pneumonia and atelectasis developed in 4 of 32 patients (13%). Patients were treated with antibiotics and incentive spirometry. There were 3 cardiac complications (9%) in the ABF group. Two patients developed atrial fibrillation, which responded to antiarrhythmic medication. One patient developed non--Qwave myocardial infarction. One patient developed cholestatic jaundice and 1 patient developed prolonged ileus (>4 days), which responded to nasogastric decompression. Three patients (9%) developed neurologic/psychiatric complications in the form of encephalopathy and depression with complete resolution before discharge. Two patients in the ABF group developed local groin wound complications in the form of superficial
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Fig 1. Abdominal aortogram showing left common, hypogastric and external iliac artery occlusion (TASC D).
wound edge necrosis and cellulitis, which cleared with local debridement and antibiotics. Aortoiliac stent group: Four patients experienced intraprocedural complications (10%). Non--flowlimiting dissection in the distal abdominal aorta occurred in 1 patient, which resolved after a few months, with a follow-up aortoiliac duplex study and arteriography showing resolution of dissection (Figs 1–4). Flow-limiting dissection in the distal abdominal aorta developed in 1 patient and was corrected with placement of bilateral iliac stents extending into the distal aorta. Contrast extravasation occurred in the external iliac artery in 1 patient, which was controlled with prolonged balloon inflation. In 1 patient, small thrombi distal to the stent developed in the distal external iliac artery and was treated with lytic therapy followed by percutaneous transluminal angioplasty and additional stent placement in the distal external iliac artery. Access-related complications occurred in 2 out of 64 sites (3.2%). Femoral pseudoaneurysm in 1 patient was treated with thrombin injection. One patient developed brachial artery occlusion, but had mild ischemic symptoms and is being followed without further intervention. One patient with diabetes mellitus required a below-the-knee amputation 9 months after iliac stenting secondary to infection and progression of infrainguinal disease. Primary patency at 48 months in the AIS group was 69 ± 12%; in the ABF group it was 93 ± .07% (P = .013; Fig 5). Secondary patency in the AIS group
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Fig 2. Reconstitution of left common femoral artery via collaterals.
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Fig 4. Non-flow limiting dissection in distal aorta (marked with arrow) resolved at follow up.
Fig 5. Kaplan-Meier Curve estimates for primary patency in patients treated by ABF and AIS primary patency at 48 months was 69% in AIS and 93% in ABF group (P = .013).
Fig 3. Placement of a long sheath into the origin of left common iliac artery with angioplasty stent placement in left common iliac and external iliac arteries.
was 89.1% and 100% in the ABF group (P > .05). Primary and secondary patency were calculated for 42 patients (intention to treat as procedure was unsuccessful in 2 patients). Comparing patients receiving bilateral stents in the AIS group (n = 24) with the ABF group (n = 32) both primary and secondary patency were better in the ABF group (P = .005 and = .013 respectively). Three patients in the AIS group had a balloon angioplasty
for in-stent stenosis within 1 year of primary interventions. One patient developed bilateral iliac stent thrombosis 9 months after the initial procedure; this was treated with lytic therapy and balloon angioplasty using combined transbrachial and bilateral femoral artery approach with successful outcome. Another patient developed a stent thrombosis secondary to common femoral occlusion in a patient with a known right superficial femoral artery occlusion, for which he had undergone prior right femoral-popliteal grafting. However, it was not functioning at the time of the iliac stenting. An endovascular approach was not attempted in this patient. The patient underwent a cross-over femoral-femoral graft with extended profundoplasty. A postoperative wound infection
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Table. Demographic and clinical data for patients undergoing treatment of TASC C and D lesions Variable
ABF (%) (n = 32)
AIS (%) (n = 40)
P Value
Age, yrs (mean ± SD) Male gender Coronary artery disease Hypertension Diabetes mellitus Chronic obstructive pulmonary disease Nicotine abuse Dyslipidemia Renal failure Infrainguinal disease Critical limb ischemia
59.2 ± 74 18 (56%) 14 (44%) 24 (75%) 5 (16%) 10 (31%)
66.6 ± 17.8 24 (60%) 24 (60%) 30 (75%) 9 (22%) 5 (13%)
.006 NS NS NS NS NS
32 23 1 22 7
(100%) (72%) (3%) (69%) (22%)
occurred in the patient’s groin, which was treated with intravenous antibiotics, debridement, and sartorious myoplasty. One patient in the ABF group developed a late graft limb thrombosis thus requiring thrombectomy of the graft with a satisfactory outcome. In the AIS group, the ankle-brachial index in the left lower extremity increased from .55 ± .22 (preintervention) to .82 ± .21 (P = .01) at last follow-up. In the right lower extremity, the ankle-brachial index increased from .52 ± .22 to .77 ± .25 (P = .01). In the ABF group, the anklebrachial index in the left lower extremity increased from .52 ± .24 to .89 ± .20 (P = .01). In the right lower extremity, the ankle-brachial index increased from .51 ± .22 to .92 ± .20 (P = .01). Follow-up revascularization. One patient in the ABF group had staged bilateral polytetrafluoroethylene (PTFE) patch angioplasty of the femoral anastomosis caused by myointimal hyperplasia. Another patient in the ABF group presented with gangrene of the fifth toe secondary to severe popliteal/ infrapopliteal occlusive disease and underwent a femoral-dorsalis pedis bypass using an autogenous vein with simultaneous amputation. Two patients in the AIS group underwent femoral endarterectomy and femoral-posterior tibial in situ bypass 3 months and 3 years later. One patient who had undergone bilateral external iliac stenting for bilateral external iliac artery occlusion developed severe right common iliac artery stenosis 5 years after the initial procedure and underwent right common iliac artery angioplasty/stent placement with satisfactory outcome. One patient had left superficial femoral artery angioplasty and stent placement for left superficial femoral artery occlusion. DISCUSSION ABF grafting is one of the most effective and durable vascular reconstruction options for
32 20 1 23 8
(78%) (50%) (3%) (58%) (20%)
.002 NS NS NS NS
aortoiliac occlusive disease.18-23 This procedure is associated with modest perioperative mortality (3%–5%).19,21 However, ABF is also associated with significant perioperative morbidity (3.8%– 21.3%) and a local morbidity of 3.5% to 22.0%.18-21 In the present series, the most common complication in the ABF group was pulmonary (13%), followed by neurological, cardiac (9%) and gastrointestinal complications (6%). DeVries and Hunink21 performed a Medline search of medical literature for ABF grafts (1970–1996) and reported a 5-year patency of 87% to 91% and a 10-year patency of 82% to 87%.21 In this report, the primary patency of the ABF group at 48 months was significantly better than the AIS (93% vs 69%; P = .013); however, secondary patency was similar (89% vs 100%; P > .05) in both groups. In addition to postoperative systemic and local complications, there is the added delay in a return to normal activities after open aortic reconstruction. An assessment of patients comorbidities and anatomy of the diseased segment (TASC types A and B vs TASC C and D) and the experience of the interventionist are important considerations in deciding between endovascular therapy and a surgical bypass.14-17 Endovascular procedures are preferred for TASC A and B lesions; surgical reconstruction are preferred for type C and D lesions.16,17 Results of iliac recanalization for iliac artery occlusions in the early series (before 1990) showed poor results with a high incidence of embolic complications.9 Since 1990, the technical success rate of recanalization of long segment iliac occlusion is reported to be 80% to 85% with or without additional thrombolysis.1-11 Recent device developments geared toward treatments of chronic total occlusions coupled with increasing experience level of interventionists, have substantially
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improved the success rates of recanalization in patients with complex aortoiliac lesions.12,14,15 The technical success rate for recanalization in the present series (TASC C and D) was 95%, aided by devices to cross chronic total occlusions. Since 1995, primary patency of 69% to 76% and secondary patency of 85% to 99% at 2 years after stent placement has been reported, which is similar to the results of AIS in this series.4,6,7,10,11 Murphy et al14 reported 74% primary patency 5 years after iliac stenting in 355 patients, but only #20% of their patients had TASC type B, C, or D lesions.14 Recently, Leville et al15 reported 89 patients (TASC B [n = 22], TASC C [n = 30], and TASC D [n = 37]) treated with endovascular therapy with technical success in 95%, primary patency in 73%, and secondary patency in 93% for TASC C lesions and primary patency in 80% and secondary patency in 83% of TASC D lesions at 36 months.15 The majority of the intraprocedural complications (dissection, perforation, and embolization) of AIS can be managed by a percutaneous approach, which is in accordance with our experience. Flow-limiting dissection often requires prolonged balloon angioplasty and additional stent placement. Embolization can be avoided by primary stenting in patients with suspected thrombus. If distal embolization does occur, lytic therapy or surgical thromboembolectomy may be necessary. Perforation of iliac artery—a serious complication—may respond to prolonged low-pressure balloon inflation and additional stenting, but often requires covered stent (stent graft) placement to control bleeding. The incidence of access site complications (3.2% in present report) may be slightly higher in patients with TASC type C and D lesions because of frequent use of a bilateral femoral (or, in some instances, a brachial artery) approach and the longer duration of the procedure. For endovascular therapy, critical limb ischemia as a presenting symptom, longer length of occlusion, multiple stents, external iliac artery occlusion, female gender, and diabetes mellitus are factors associated with decreased primary patency.11,12,14,15 Valentine et al24 and Reed et al25 reported that neither the type of proximal anastomosis (end-to-end or end-to-side) nor the gender affected patency of the aortobifemoral reconstruction, but patients with small aortic diameters had inferior patency. Because of a relatively small sample size, an univariate analysis of risk factors affecting patency was not performed in this series. The incidence of restenosis in the AIS group of 12% (5 out of 40) is similar to the reported incidence of 18% to 28%.10,11,14 Anastomotic stenosis and thrombosis
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of the femoral limb of the ABF graft is an infrequent occurrence.18,21 In the present report, 1 patient developed bilateral stenosis at femoral anastomosis; another patient developed thrombosis of the iliac limb of ABF graft. Both patients underwent open operations for these complications with satisfactory outcomes. Some surgeons prefer crossover femoral-femoral graft reconstruction for unilateral iliac artery occlusion provided there is no evidence of contralateral iliac artery disease. We believe that direct percutaneous intervention is preferable (if feasible). We do not have data to support this approach. For both AIS and ABF, it is important to have adequate outflow. Eight patients in the ABF group underwent simultaneous profundoplasty, and 1 patient underwent a simultaneous femoral-popliteal graft for adequate outflow because the profunda femoral artery was small in caliber. Six patients in the AIS group underwent treatment for concomitant infrainguinal disease. One patient in the AIS group developed stent thrombosis owing to the progression of common femoral artery occlusive disease with a known superficial femoral artery occlusion. Timely intervention for common femoral artery occlusive disease may have prevented stent thrombosis. There was no operative mortality or periprocedural mortality in either group, but this may be due to the small number of patients in ABF group. Primary patency was inferior in the AIS group; however, secondary patency in the AIS group is acceptable and almost equivalent to secondary patency of the ABF group. All patients except 1 with restenosis/occlusion AIS were treated successfully with percutaneous intervention after AIS. The length of stay was significantly longer in the ABF group owing to the extensive nature of the reconstruction and concomitant significant perioperative morbidity. The majority of the patients in the AIS group were discharged after an overnight stay. The primary limitation of this study is its retrospective nature and a relatively small sample size. However, despite this limitation, our results reveal that patients with severe aortoiliac occlusive disease (TASC types C and D) can be treated with AIS or ABF with satisfactory results. Compared with ABF, AIS is associated with decreased perioperative morbidity and primary patency. The repair of concomitant femoral artery occlusive disease to provide adequate outflow is important regardless of open reconstruction or endovascular therapy. Prospective evaluation of these 2 modalities of treatment with a larger number of patients will be required to assess the superiority of ABF over AIS.
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The authors would like to thank Srinivas Koneru, MD, Charles Nino, MD, Luay Sayed, MD, and Hiroshi Yamasaki, MD, for allowing us to include their patients, Simone Leszinsky, PA, for data collection and Gautam Hans for editorial aid.
REFERENCES 1. Bosch JL, van der Graaf Y, Hunink MG. Health-related quality of life after angioplasty and stent placement in patients with iliac artery occlusive disease: results of a randomized, controlled trial. Circulation 1999;99:3155-60. 2. Johnston KW. Iliac arteries: reanalysis of results of balloon angioplasty. Radiology 1993;186:207-12. 3. Blum U, Gabelmann A, Redecker M, Noldge G, Domberg W, Grosser G, et al. Percutaneous recanalization of iliac artery occlusions: results of a prospective study. Radiology 1993; 189:536-40. 4. Dyet JF, Gaines PA, Nicholson AA, Cleveland T, Cook AM, Wilkinson AR, et al. Treatment of chronic iliac artery occlusions by means of percutaneous endovascular stent placement. J Vasc Inter Radiol 1997;8:349-53. 5. Henry M, Amor M, Ethevenot G, Henry I, Mentre B, Tzvetanov K. Percutaneous endoluminal treatment of iliac occlusions: long-term follow-up in 105 patients. J Endovasc Surg 1998;5:228-35. 6. Uher P, Nyman U, Lindh M, Lindblad B, Ivancev K. Longterm results for stenting chronic iliac artery occlusions. J Endovasc Ther 2002;9:67-75. 7. Saket RR, Razavi MK, Padidar A, Kee ST, Sze DY, Dake MD. Novel intravascular ultrasound-guided method to create transintimal arterial communications: initial experience in peripheral occlusive disease and aortic dissection. J Endovasc Ther 2004;11:274-80. 8. Carnevale FC, DeBlas M, Merino S, Egana JM, Caldas JG. Percutaneous endovascular treatment of chronic iliac artery occlusion. Cardiovasc Intervent Radiol 2004;27:447-52. 9. Ring EJ, Freiman DB, McLean GK, Schwarz W. Percutaneous recanalization of common iliac artery occlusions: an unacceptable complication rate? AJR Am J Roentgenol 1982; 139:587-9. 10. Tetteroo E, van deer Graaf Y, Bosch JL, van Engelen AD, Hunink MG, Eikelboom BC, et al. Randomized comparison of primary stent placement versus primary angioplasty followed by selective stent placement in patients with iliac artery occlusive disease. Lancet 1998;351:1153-9. 11. Bosch JL, Hunink MG. Meta-analysis of the results of percutaneous transluminal angioplasty and stent placement for aortoiliac occlusive disease. Radiology 1997;205:87-96. 12. Sullivan TM, Childs MB, Bacharach JM, Gray BH, Piedmonte MR. Percutaneous transluminal angioplasty and primary stenting of the iliac arteries in 288 patients. J Vasc Surg 1997;25:829-39. 13. Nelson PR, Powell RJ, Schermerhorn ML, Fillinger MF, Zwolak RM, Walsh DB, et al. Early results of external iliac artery stenting combined with common femoral artery endarterectomy. J Vasc Surg 2002;35:1107-13. 14. Murphy TP, Ariaratnam NS, Carney WI, Jr. Marcaccio EJ, Slaiby JM, Soares GM, et al. Aortoiliac insufficiency: longterm experience with stent placement treatment. Radiology 2004;231:243-9. 15. LeVille CD, Kashyap VS, Clair DG, Bena JF, Leyden SP, et al. Endovascular management of iliac artery occlusion: extending treatment to TransAtlantic Inter-Society Consensus class C and D patients. J Vasc Surg 2006;43:32-9.
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16. Management of peripheral arterial disease (PAD). TransAltlantic Inter-Society Consensus (TASC). J Vasc Surg 2000; 31(Suppl):1-296. 17. Inter-Society Consensus for the management of peripheral arterial disease (TASC II). J Vasc Surg 2007;45(Suppl): 55A-567. 18. Szilagyi De, Elliott JP Jr, Smith RF, Reddy DJ, McPharlin M. A thirty-year survey of the reconstructive surgical treatment of aortoiliac occlusive disease. J Vasc Surg 1986;3:421-36. 19. Poulias GE, Doundoulakis N, Prombonas E, Haddad H, Papaioannou K, Lymberiades D, et al. Aorto-femoral bypass and determinants of early success or late favorable outcome. Experience with 1000 consecutive cases. J Cardiovasc Surg 1992;33:664-78. 20. Nevelsteen A, Wouters L, Suy R. Aortofemoral reconstruction for aortoiliac occlusive disease: a 25 year survey. Eur J Vasc Surg 19911;5:179-186. 21. DeVries SO, Hunink MG. Results of aortic bifurcation grafts for aortoiliac occlusive disease: a meta-analysis. J Vasc Surg 1997;26:558-69. 22. Rutherford RB, Baker JD, Ernst C, Johnston KW, Porter JM, Ahn S, et al. Recommended standards for report dealing with lower extremity ischemia. Revised version. J Vasc Surg 1997;26:517-38. 23. van den Akker PJ, Van Schilfgaarde R, Braud R, Van Bockel JH, Terpstra JL. Long-term success of aortoiliac operations for arteriosclerotic obstructive disease. Surg Gynecol Obstet 1992;174:485-96. 24. Valentine RJ, Hansen ME, Myers SI, Chevru A, Clagett GP. The influence of sex and aortic size in late patency after aortofemoral revascularization in young adults. J Vasc Surg 1995;21:296-306. 25. Reed AB, Conte MS, Donaldson MC, Mannick JA, Whitttemore AD, Belkin M. The impact of patient age and aortic size on the results of aortobifemoral bypass grafting. J Vasc Surg 2003;37:1219-25.
DISCUSSION Dr G. B. Zelenock (Toledo, Ohio): Dr Hans and his colleagues are to be commended for this scholarly presentation. This manuscript is carefully reported, well illustrated, very thoroughly analyzed, and it addresses a topic of considerable importance to vascular surgeons. The report carefully defines an internationally accepted classification, TASC classification, to describe and categorize the patients undergoing aortoiliac reconstruction, and it seems that the results are comparable regardless of whether they underwent endovascular or open repair except for the primary patency and shorter length of stay, which Dr Hans addressed. I would point out that their results, both open and endovascular, are among the very best reported in any published series to date, with no mortalities and very excellent limb salvage rates. So my questions are: Because this is a nonrandomized study, how did they select which of these C and D patients would actually receive a bypass versus a stenting procedure? And then, given the rapid advances in the endovascular devices and technology, and, importantly, the very much increased level of sophistication among vascular surgeons with endovascular techniques, do you think it is possible that within a few short years we will not be doing any open procedures any longer?
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Dr Sachinder S. Hans (Warren, Mich): I want to thank you for your kind comments, and I also wish to acknowledge your leadership in getting us started with the endovascular aneurysm repairs. I think your leadership provided us an incentive to perform these complex interventions. As for your questions and concerns regarding patient selection, obviously this is a nonrandomized retrospective study. Prior to the year 2000, we performed aortofemoral grafting for complex TASC C & D lesions on these patients with TASC C and D lesions. But as our experience with endovascular approach grew, and as new devices to cross chronic total occlusions became available, we became somewhat more confident, maybe sometimes somewhat foolish, but we decided to handle these complex TASC C and D lesions by endovascular approach. Now, I would say this, that these procedures can take as long as 2 to 3 hours and sometimes more, and you should be prepared to handle these complications as iliac rupture can be fatal. There are some patients that we will absolutely not consider for stenting, such as patients who have severe calcification. These lesions are difficult to dilate, and have high risk of complications, and so we prefer open bypass for long segment calcific lesions. What about the future? I think we are doing a fewer number of open aortoiliac reconstruction—at 1 time in my own years in my practice I used to do 15 or 20 aortoiliac reconstructions for occlusive disease and now I only do 2 or 3. I think the open reconstructions are here to stay for a while but many of these open reconstructions will be taken over by endovascular approach. Dr Scott A. Gruber (Detroit, Mich): I enjoyed your presentation. I have 1 question. Did any of these patients have renal insufficiency or renal failure, or could potentially be a candidate for a kidney transplant? I ask because I am concerned with all these stents being placed in the vessels that we use for transplantation, you are taking away future spots for kidneys, and so I just wanted to get your viewpoint on this. Dr Sachinder S. Hans (Warren, Mich): I think your point is well taken. We will not do this procedure in a patient with markedly elevated creatinine or one who is potentially considered for a renal transplant. The reason for that is we could end up using 200 to 300 cc of contrast in some of these patients. We do prep them with hydration and Mucomyst. Some patients do have high creatinines. But usually they are below 2 mg/dl. Some
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are between 1.5 mg/dl and 2.0 mg/dl, but the majority of these patients have normal creatinines. Dr Jean Starr (Columbus, Ohio): I would like to commend you on your results because, as you know, in this day and age when industry gives us 6-month results and sometimes up to 1-year results and sometimes other specialties not following their patients out so far, we obviously have an advantage to find surgical and endovascular patients. And 4 years is a great period of time to be able to compare these 2. And obviously those results are very, very good. I would like to ask a few technical questions. First of all, do you help decide on whether you are going to approach it endovascularly versus open based on the proximity to the calcifications in the artery and the need to place a sheath in the area or do you automatically decide to go contralateral on those? Second of all, are all of yours done with the subintimal technique where we are not truly in the lumen? I notice you are using a lot of re-entry type devices. And based on that, do you think your results could be maybe improved with using a balloon expandable stent or a covered stent graft as opposed to a self-expanding stent? Dr Sachinder S. Hans (Warren, Mich): My personal feeling is that if the lesion is above the acetabulum— that is, reconstitution of the common femoral artery—it can be handled via endovascular approach. That means you should be able to see 1 branch of the external iliac artery that is either deep epigastric or circumflex iliac. Even if you do not see those branches, the procedure can still be done as some interventionists will approach that either through the brachial artery, or the opposite groin, or with a combined brachial/ femoral approach, so that would be our choice. My limit would be that if the lesion extends beyond the acetabulum I would probably be reluctant to do that endovascularly. As far as your second question is concerned, even if you are subintimal, you should try to maneuver the guidewire back into the true lumen, but do not deploy a stent until you confirm that you are in the true lumen. And your question regarding stent grafts. I have only used stent graft in only 1 patient, although there is a series from Dartmouth where they have exclusively used stent grafts. But my own feeling is that the majority of these patients can be treated with either balloon expandable stents for the lesions at the mouth of the common iliac arteries or self-expanding stents as you go down to the external iliac arteries.
Objective. The purpose of this study was to compare the outcomes of aortoiliac stenting (AIS) to those of aortobifemoral grafting (ABF) for patients with TransAtlantic Inter-Society Consensus (TASCII) C and D aortoiliac occlusive disease. Methods. From 1998 to 2007, 32 patients underwent ABF and 40 patients underwent AIS. KaplanMeier estimates for patency were used. Results. Patients undergoing AIS were older (66.6 years ABF vs 59.2 years AIS; P=.006). The ABF group had simultaneous profundoplasty (n = 8) and femoral-popliteal graft (n = 1). Six patients had treatment for concomitant infrainguinal disease at the time of AIS. There was no mortality in either group. Average hospital stay in the ABF group was 7 ± 2 days and 1 ± 0.3 days for AIS (P = .0001). Pulmonary complications predominated in the ABF group (13%). Four patients in the AIS group (10%) developed intraprocedural complications. Primary patency at 48 months was 69 ± .12% for AIS and 93 ± .07% for ABF (P = .013). There was a significant increase in ankle-brachial indices after revascularization in both groups. Conclusions. TASC type C and D lesions can be treated with either ABF or AIS with satisfactory results. Compared with ABF, AIS is associated with decreased primary patency, decreased perioperative morbidity, and shorter hospital stay. (Surgery 2008;144:583-90.) From the Henry Ford Macomb Hospital,a Clinton Township; and the St John Macomb Hospital, Section of Vascular Surgery and Vascular Intervention,b Warren, Mich
THE MANAGEMENT OF AORTOILIAC OCCLUSIVE DISEASE has undergone considerable evolution during the past 2 decades, primarily owing to the advent of balloon angioplasty and stent technology.1-15 The publication of the TransAtlantic Inter-Society Consensus (TASC) statement (2000) allows stratification of peripheral artery occlusive disease by lesion morphology.16 Recently, a new Consensus document (2007) with broader international presentation focusing on key aspects of diagnosis and treatment of lower extremity arterial occlusive disease was published.17 According to the TASCII classification of
Presented at the 65th Annual Meeting of the Central Surgical Association, Cincinnati, Ohio, March 6–8, 2008. Accepted for publication June 26, 2008. Reprint requests: Sachinder Singh Hans, MD, St John Macomb Hospital, Department of Surgery, 28411 Hoover, Warren, MI 48093. E-mail: [email protected]. 0039-6060/$ - see front matter Ó 2008 Mosby, Inc. All rights reserved. doi:10.1016/j.surg.2008.06.021
aortoiliac occlusive disease, lesions can be classified into categories A, B, C, or D with type A representing short, segmental stenosis of the common or external iliac artery. The lesions increase in complexity from type B, then to type C, and finally with type D representing long segment occlusions of the common and external iliac artery.17 As per recommendations of the TASC panel, endovascular therapy is the preferred method of treatment for type A lesions. Surgery is preferred for type D lesions.17 Some patients with type B and C lesions can be managed by either surgery or endovascular therapy, depending on the patient’s informed choice, medical comorbidities, and the experience level of the interventionist/surgeon.17 Recent device development to cross chronic total occlusions and rising experience levels among interventionists has increased the utilization of endovascular therapy for complex aortoiliac lesions.15,17 The purpose of this study was to compare the outcomes and durability of aortoiliac stenting (AIS) to those of aortobifemoral bypass grafting (ABF) for TASC types C and D aortoiliac occlusive disease. SURGERY 583
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PATIENTS AND METHODS Between 1998 and December 2007, 312 patients underwent arteriography for symptomatic aortoiliac occlusive disease. Two hundred twenty-eight patients underwent iliac angioplasty for TASC type A and B lesions. Eighty-four patients had treatment for TASC type C and D lesions. Endovascular treatment was attempted in 42 patients and successful in 40 patients. ABF was performed in 32 patients. Three patients underwent axillofemoral grafting, 7 underwent iliofemoral/crossover femoral-femoral grafting, and 2 patients refused intervention. The study was approved by the institutional review boards of both hospitals. The senior author (SSH) performed all ABF graft procedures and the majority of AIS procedures (28 out of 40). Clinical interventional and operative and postoperative data were obtained from the hospital and physicians’ office records. The data were kept in an ongoing vascular registry on a continuous basis. Preoperative demographic data, risk factors for atherosclerosis, and clinical symptoms were studied. Symptoms of lower extremity ischemia were classified into intermittent claudication or critical limb ischemia, later consisting of ischemic rest pain, ischemic ulceration, or gangrene of the toes. Endovascular procedures were performed in either the interventional radiology or cardiac catheterization laboratories using a fixed fluoroscopic unit. Two patients with TASC type C and D lesions underwent iliac stenting with simultaneous femoral endarterectomy as well as a distal bypass in the operating room using a portable OEC9800 unit (General Electric, Fairfield, Conn). All endovascular procedures were performed under systemic heparinization with pre- and postinterventional administration of antiplatelet medication (aspirin and clopidogrel). After undergoing a clinical examination and a noninvasive arterial evaluation, the patients underwent arteriography via femoral artery approach, with the subsequent passage of a hydrophilic wire (in some cases, Magic Torque; Boston Scientific, Natick, Mass). The passage of the wire was intraluminal or subintimal (intraplaque) in some patients with total occlusions. Bilateral femoral puncture was performed in 23 patients, unilateral femoral puncture in 14, and a combined femoral/brachial artery approach in 3. Associated common femoral atherectomy was performed in 1 patient and common femoral balloon angioplasty was performed in 2. One patient underwent a simultaneous common femoral artery endarterectomy, another underwent a common femoral endarterectomy and femoral-infrapopliteal
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(vein) bypass in the operating room, after iliac angioplasty and stent placement. All patients had a prestent angioplasty followed by stent placement and a poststent angioplasty. In general, 8.0- to 10.0-mm balloons were used for common iliac arteries, and 6.0- to 8.0-mm balloons for external iliac arteries for poststent angioplasty. Stents were placed bilaterally in 24 patients (48 limbs), in the right common and external iliac arteries in 6 limbs, and in the left common and external iliac arteries in 10 limbs. A total of 101 stents were deployed including 1 covered stent (FLUENCY; Bard Peripheral Vascular, Tempe, Ariz). Self-expanding Nitinol (SMART stent; Cordis, Johnson & Johnson, Cincinnati, Ohio) and, more recently, Prote´ge´ (EV3; Plymouth, Minn) were used predominantly. Balloon-extendable stents were used for the distal abdominal aorta and at the origin of the common iliac artery. In patients with a chronic total occlusion of the iliac artery, Frontrunner catheter (Cordis, Johnson & Johnson) were used in 4 patients and OUTBACK LTD catheter (Cordis, Johnson & Johnson) was used in 2 patients. A Pioneer intravascular ultrasound catheter (Medtronic, Indianapolis, Ind) was used to traverse chronic occlusion in 1 patient. A GOOSE NECK snare (EV3) was used to retrieve guide wires in 4 patients. In 1 patient, intravascular ultrasound was used to assist in the angioplasty/stent placement. Closure devices were infrequently used in this series. ABF procedures were performed in the operating room under general anesthesia via a transperitoneal approach in all patients. Follow-up was obtained in all patients with the exception of 2 in the ABF group (mean follow-up, 31.9 ± 33.9 months). All patients underwent clinical evaluation and a noninvasive Doppler arterial study (including toe pressures and ankle-brachial indices) at 1 month, 3 months, and 1 year, followed by a biannual or annual follow-up. Patency was assessed by clinical examination and noninvasive Doppler arterial study. Patients developing recurrent ischemic symptoms or positive noninvasive study results underwent conventional digital subtraction arteriography, magnetic resonance angiography, or computed tomographic angiography. Statistical methods. Data were analyzed using SPSS for Windows V15.0 (SPSS, Inc., Chicago, Ill). Kaplan-Meier survival analysis was used to examine primary and secondary patency and limb survival. Paired sample t-tests were used to compare the preand post-ABI values in both groups (endovascular procedures and surgical bypass procedures were grouped separately).
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RESULTS Thirty-two patients (64 limbs) underwent ABF and 40 patients (68 limbs) underwent AIS. In the AIS group, 27 patients had TASC type C lesions and 13 had TASC type D lesions. In the ABF group, 19 patients had TASC C lesions and 13 patients had TASC D lesions. There was no difference between the relative number of TASC C and D lesions in AIS and ABF group (P = NS). Procedures were technically successful in 40 out of 42 patients in the AIS group (95%), and in all patients in the ABF group. Symptoms displayed by patients undergoing AIS (n = 40), included intermittent claudication (n = 32), rest pain (n = 4), and ulceration/ gangrene of the toes (n = 4). Patients undergoing ABF (n = 32) presented with intermittent claudication (n = 25), rest pain (n = 3), and gangrene/ulceration of the toes (n = 4). Patients undergoing ABF had a mean age of 59.2 ± 7.4 years; patients undergoing AIS were older (66.6 ± 11.8 years; P = .006). Other demographic and clinical variables were similar in both groups, excluding incidence of smoking, which was higher in the ABF group (Table). Proximal anastomosis was end-to-end in the majority of patients (30 out of 32), and end-toside in 2 patients. In the majority of patients (n = 22), 16.0 3 8.0 mm knitted Dacron grafts were used; 14.0 3 7.0 mm grafts were used in 8 patients, and 18.0 3 9.0 mm grafts were used in 2. Patients in the ABF group underwent concomitant profundoplasty (n = 8) and femoral-popliteal graft (n = 1). Aorto right lower pole renal artery bypass was performed in 1 patient. The average hospital stay in the ABF group was 7 ± 2 days compared with 1 ± 0.3 days in the AIS group (P = .0001). Complications. There was no perioperative mortality in either group. Aortobifemoral group: Postoperative pulmonary complications in the form of pneumonia and atelectasis developed in 4 of 32 patients (13%). Patients were treated with antibiotics and incentive spirometry. There were 3 cardiac complications (9%) in the ABF group. Two patients developed atrial fibrillation, which responded to antiarrhythmic medication. One patient developed non--Qwave myocardial infarction. One patient developed cholestatic jaundice and 1 patient developed prolonged ileus (>4 days), which responded to nasogastric decompression. Three patients (9%) developed neurologic/psychiatric complications in the form of encephalopathy and depression with complete resolution before discharge. Two patients in the ABF group developed local groin wound complications in the form of superficial
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Fig 1. Abdominal aortogram showing left common, hypogastric and external iliac artery occlusion (TASC D).
wound edge necrosis and cellulitis, which cleared with local debridement and antibiotics. Aortoiliac stent group: Four patients experienced intraprocedural complications (10%). Non--flowlimiting dissection in the distal abdominal aorta occurred in 1 patient, which resolved after a few months, with a follow-up aortoiliac duplex study and arteriography showing resolution of dissection (Figs 1–4). Flow-limiting dissection in the distal abdominal aorta developed in 1 patient and was corrected with placement of bilateral iliac stents extending into the distal aorta. Contrast extravasation occurred in the external iliac artery in 1 patient, which was controlled with prolonged balloon inflation. In 1 patient, small thrombi distal to the stent developed in the distal external iliac artery and was treated with lytic therapy followed by percutaneous transluminal angioplasty and additional stent placement in the distal external iliac artery. Access-related complications occurred in 2 out of 64 sites (3.2%). Femoral pseudoaneurysm in 1 patient was treated with thrombin injection. One patient developed brachial artery occlusion, but had mild ischemic symptoms and is being followed without further intervention. One patient with diabetes mellitus required a below-the-knee amputation 9 months after iliac stenting secondary to infection and progression of infrainguinal disease. Primary patency at 48 months in the AIS group was 69 ± 12%; in the ABF group it was 93 ± .07% (P = .013; Fig 5). Secondary patency in the AIS group
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Fig 2. Reconstitution of left common femoral artery via collaterals.
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Fig 4. Non-flow limiting dissection in distal aorta (marked with arrow) resolved at follow up.
Fig 5. Kaplan-Meier Curve estimates for primary patency in patients treated by ABF and AIS primary patency at 48 months was 69% in AIS and 93% in ABF group (P = .013).
Fig 3. Placement of a long sheath into the origin of left common iliac artery with angioplasty stent placement in left common iliac and external iliac arteries.
was 89.1% and 100% in the ABF group (P > .05). Primary and secondary patency were calculated for 42 patients (intention to treat as procedure was unsuccessful in 2 patients). Comparing patients receiving bilateral stents in the AIS group (n = 24) with the ABF group (n = 32) both primary and secondary patency were better in the ABF group (P = .005 and = .013 respectively). Three patients in the AIS group had a balloon angioplasty
for in-stent stenosis within 1 year of primary interventions. One patient developed bilateral iliac stent thrombosis 9 months after the initial procedure; this was treated with lytic therapy and balloon angioplasty using combined transbrachial and bilateral femoral artery approach with successful outcome. Another patient developed a stent thrombosis secondary to common femoral occlusion in a patient with a known right superficial femoral artery occlusion, for which he had undergone prior right femoral-popliteal grafting. However, it was not functioning at the time of the iliac stenting. An endovascular approach was not attempted in this patient. The patient underwent a cross-over femoral-femoral graft with extended profundoplasty. A postoperative wound infection
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Table. Demographic and clinical data for patients undergoing treatment of TASC C and D lesions Variable
ABF (%) (n = 32)
AIS (%) (n = 40)
P Value
Age, yrs (mean ± SD) Male gender Coronary artery disease Hypertension Diabetes mellitus Chronic obstructive pulmonary disease Nicotine abuse Dyslipidemia Renal failure Infrainguinal disease Critical limb ischemia
59.2 ± 74 18 (56%) 14 (44%) 24 (75%) 5 (16%) 10 (31%)
66.6 ± 17.8 24 (60%) 24 (60%) 30 (75%) 9 (22%) 5 (13%)
.006 NS NS NS NS NS
32 23 1 22 7
(100%) (72%) (3%) (69%) (22%)
occurred in the patient’s groin, which was treated with intravenous antibiotics, debridement, and sartorious myoplasty. One patient in the ABF group developed a late graft limb thrombosis thus requiring thrombectomy of the graft with a satisfactory outcome. In the AIS group, the ankle-brachial index in the left lower extremity increased from .55 ± .22 (preintervention) to .82 ± .21 (P = .01) at last follow-up. In the right lower extremity, the ankle-brachial index increased from .52 ± .22 to .77 ± .25 (P = .01). In the ABF group, the anklebrachial index in the left lower extremity increased from .52 ± .24 to .89 ± .20 (P = .01). In the right lower extremity, the ankle-brachial index increased from .51 ± .22 to .92 ± .20 (P = .01). Follow-up revascularization. One patient in the ABF group had staged bilateral polytetrafluoroethylene (PTFE) patch angioplasty of the femoral anastomosis caused by myointimal hyperplasia. Another patient in the ABF group presented with gangrene of the fifth toe secondary to severe popliteal/ infrapopliteal occlusive disease and underwent a femoral-dorsalis pedis bypass using an autogenous vein with simultaneous amputation. Two patients in the AIS group underwent femoral endarterectomy and femoral-posterior tibial in situ bypass 3 months and 3 years later. One patient who had undergone bilateral external iliac stenting for bilateral external iliac artery occlusion developed severe right common iliac artery stenosis 5 years after the initial procedure and underwent right common iliac artery angioplasty/stent placement with satisfactory outcome. One patient had left superficial femoral artery angioplasty and stent placement for left superficial femoral artery occlusion. DISCUSSION ABF grafting is one of the most effective and durable vascular reconstruction options for
32 20 1 23 8
(78%) (50%) (3%) (58%) (20%)
.002 NS NS NS NS
aortoiliac occlusive disease.18-23 This procedure is associated with modest perioperative mortality (3%–5%).19,21 However, ABF is also associated with significant perioperative morbidity (3.8%– 21.3%) and a local morbidity of 3.5% to 22.0%.18-21 In the present series, the most common complication in the ABF group was pulmonary (13%), followed by neurological, cardiac (9%) and gastrointestinal complications (6%). DeVries and Hunink21 performed a Medline search of medical literature for ABF grafts (1970–1996) and reported a 5-year patency of 87% to 91% and a 10-year patency of 82% to 87%.21 In this report, the primary patency of the ABF group at 48 months was significantly better than the AIS (93% vs 69%; P = .013); however, secondary patency was similar (89% vs 100%; P > .05) in both groups. In addition to postoperative systemic and local complications, there is the added delay in a return to normal activities after open aortic reconstruction. An assessment of patients comorbidities and anatomy of the diseased segment (TASC types A and B vs TASC C and D) and the experience of the interventionist are important considerations in deciding between endovascular therapy and a surgical bypass.14-17 Endovascular procedures are preferred for TASC A and B lesions; surgical reconstruction are preferred for type C and D lesions.16,17 Results of iliac recanalization for iliac artery occlusions in the early series (before 1990) showed poor results with a high incidence of embolic complications.9 Since 1990, the technical success rate of recanalization of long segment iliac occlusion is reported to be 80% to 85% with or without additional thrombolysis.1-11 Recent device developments geared toward treatments of chronic total occlusions coupled with increasing experience level of interventionists, have substantially
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improved the success rates of recanalization in patients with complex aortoiliac lesions.12,14,15 The technical success rate for recanalization in the present series (TASC C and D) was 95%, aided by devices to cross chronic total occlusions. Since 1995, primary patency of 69% to 76% and secondary patency of 85% to 99% at 2 years after stent placement has been reported, which is similar to the results of AIS in this series.4,6,7,10,11 Murphy et al14 reported 74% primary patency 5 years after iliac stenting in 355 patients, but only #20% of their patients had TASC type B, C, or D lesions.14 Recently, Leville et al15 reported 89 patients (TASC B [n = 22], TASC C [n = 30], and TASC D [n = 37]) treated with endovascular therapy with technical success in 95%, primary patency in 73%, and secondary patency in 93% for TASC C lesions and primary patency in 80% and secondary patency in 83% of TASC D lesions at 36 months.15 The majority of the intraprocedural complications (dissection, perforation, and embolization) of AIS can be managed by a percutaneous approach, which is in accordance with our experience. Flow-limiting dissection often requires prolonged balloon angioplasty and additional stent placement. Embolization can be avoided by primary stenting in patients with suspected thrombus. If distal embolization does occur, lytic therapy or surgical thromboembolectomy may be necessary. Perforation of iliac artery—a serious complication—may respond to prolonged low-pressure balloon inflation and additional stenting, but often requires covered stent (stent graft) placement to control bleeding. The incidence of access site complications (3.2% in present report) may be slightly higher in patients with TASC type C and D lesions because of frequent use of a bilateral femoral (or, in some instances, a brachial artery) approach and the longer duration of the procedure. For endovascular therapy, critical limb ischemia as a presenting symptom, longer length of occlusion, multiple stents, external iliac artery occlusion, female gender, and diabetes mellitus are factors associated with decreased primary patency.11,12,14,15 Valentine et al24 and Reed et al25 reported that neither the type of proximal anastomosis (end-to-end or end-to-side) nor the gender affected patency of the aortobifemoral reconstruction, but patients with small aortic diameters had inferior patency. Because of a relatively small sample size, an univariate analysis of risk factors affecting patency was not performed in this series. The incidence of restenosis in the AIS group of 12% (5 out of 40) is similar to the reported incidence of 18% to 28%.10,11,14 Anastomotic stenosis and thrombosis
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of the femoral limb of the ABF graft is an infrequent occurrence.18,21 In the present report, 1 patient developed bilateral stenosis at femoral anastomosis; another patient developed thrombosis of the iliac limb of ABF graft. Both patients underwent open operations for these complications with satisfactory outcomes. Some surgeons prefer crossover femoral-femoral graft reconstruction for unilateral iliac artery occlusion provided there is no evidence of contralateral iliac artery disease. We believe that direct percutaneous intervention is preferable (if feasible). We do not have data to support this approach. For both AIS and ABF, it is important to have adequate outflow. Eight patients in the ABF group underwent simultaneous profundoplasty, and 1 patient underwent a simultaneous femoral-popliteal graft for adequate outflow because the profunda femoral artery was small in caliber. Six patients in the AIS group underwent treatment for concomitant infrainguinal disease. One patient in the AIS group developed stent thrombosis owing to the progression of common femoral artery occlusive disease with a known superficial femoral artery occlusion. Timely intervention for common femoral artery occlusive disease may have prevented stent thrombosis. There was no operative mortality or periprocedural mortality in either group, but this may be due to the small number of patients in ABF group. Primary patency was inferior in the AIS group; however, secondary patency in the AIS group is acceptable and almost equivalent to secondary patency of the ABF group. All patients except 1 with restenosis/occlusion AIS were treated successfully with percutaneous intervention after AIS. The length of stay was significantly longer in the ABF group owing to the extensive nature of the reconstruction and concomitant significant perioperative morbidity. The majority of the patients in the AIS group were discharged after an overnight stay. The primary limitation of this study is its retrospective nature and a relatively small sample size. However, despite this limitation, our results reveal that patients with severe aortoiliac occlusive disease (TASC types C and D) can be treated with AIS or ABF with satisfactory results. Compared with ABF, AIS is associated with decreased perioperative morbidity and primary patency. The repair of concomitant femoral artery occlusive disease to provide adequate outflow is important regardless of open reconstruction or endovascular therapy. Prospective evaluation of these 2 modalities of treatment with a larger number of patients will be required to assess the superiority of ABF over AIS.
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The authors would like to thank Srinivas Koneru, MD, Charles Nino, MD, Luay Sayed, MD, and Hiroshi Yamasaki, MD, for allowing us to include their patients, Simone Leszinsky, PA, for data collection and Gautam Hans for editorial aid.
REFERENCES 1. Bosch JL, van der Graaf Y, Hunink MG. Health-related quality of life after angioplasty and stent placement in patients with iliac artery occlusive disease: results of a randomized, controlled trial. Circulation 1999;99:3155-60. 2. Johnston KW. Iliac arteries: reanalysis of results of balloon angioplasty. Radiology 1993;186:207-12. 3. Blum U, Gabelmann A, Redecker M, Noldge G, Domberg W, Grosser G, et al. Percutaneous recanalization of iliac artery occlusions: results of a prospective study. Radiology 1993; 189:536-40. 4. Dyet JF, Gaines PA, Nicholson AA, Cleveland T, Cook AM, Wilkinson AR, et al. Treatment of chronic iliac artery occlusions by means of percutaneous endovascular stent placement. J Vasc Inter Radiol 1997;8:349-53. 5. Henry M, Amor M, Ethevenot G, Henry I, Mentre B, Tzvetanov K. Percutaneous endoluminal treatment of iliac occlusions: long-term follow-up in 105 patients. J Endovasc Surg 1998;5:228-35. 6. Uher P, Nyman U, Lindh M, Lindblad B, Ivancev K. Longterm results for stenting chronic iliac artery occlusions. J Endovasc Ther 2002;9:67-75. 7. Saket RR, Razavi MK, Padidar A, Kee ST, Sze DY, Dake MD. Novel intravascular ultrasound-guided method to create transintimal arterial communications: initial experience in peripheral occlusive disease and aortic dissection. J Endovasc Ther 2004;11:274-80. 8. Carnevale FC, DeBlas M, Merino S, Egana JM, Caldas JG. Percutaneous endovascular treatment of chronic iliac artery occlusion. Cardiovasc Intervent Radiol 2004;27:447-52. 9. Ring EJ, Freiman DB, McLean GK, Schwarz W. Percutaneous recanalization of common iliac artery occlusions: an unacceptable complication rate? AJR Am J Roentgenol 1982; 139:587-9. 10. Tetteroo E, van deer Graaf Y, Bosch JL, van Engelen AD, Hunink MG, Eikelboom BC, et al. Randomized comparison of primary stent placement versus primary angioplasty followed by selective stent placement in patients with iliac artery occlusive disease. Lancet 1998;351:1153-9. 11. Bosch JL, Hunink MG. Meta-analysis of the results of percutaneous transluminal angioplasty and stent placement for aortoiliac occlusive disease. Radiology 1997;205:87-96. 12. Sullivan TM, Childs MB, Bacharach JM, Gray BH, Piedmonte MR. Percutaneous transluminal angioplasty and primary stenting of the iliac arteries in 288 patients. J Vasc Surg 1997;25:829-39. 13. Nelson PR, Powell RJ, Schermerhorn ML, Fillinger MF, Zwolak RM, Walsh DB, et al. Early results of external iliac artery stenting combined with common femoral artery endarterectomy. J Vasc Surg 2002;35:1107-13. 14. Murphy TP, Ariaratnam NS, Carney WI, Jr. Marcaccio EJ, Slaiby JM, Soares GM, et al. Aortoiliac insufficiency: longterm experience with stent placement treatment. Radiology 2004;231:243-9. 15. LeVille CD, Kashyap VS, Clair DG, Bena JF, Leyden SP, et al. Endovascular management of iliac artery occlusion: extending treatment to TransAtlantic Inter-Society Consensus class C and D patients. J Vasc Surg 2006;43:32-9.
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16. Management of peripheral arterial disease (PAD). TransAltlantic Inter-Society Consensus (TASC). J Vasc Surg 2000; 31(Suppl):1-296. 17. Inter-Society Consensus for the management of peripheral arterial disease (TASC II). J Vasc Surg 2007;45(Suppl): 55A-567. 18. Szilagyi De, Elliott JP Jr, Smith RF, Reddy DJ, McPharlin M. A thirty-year survey of the reconstructive surgical treatment of aortoiliac occlusive disease. J Vasc Surg 1986;3:421-36. 19. Poulias GE, Doundoulakis N, Prombonas E, Haddad H, Papaioannou K, Lymberiades D, et al. Aorto-femoral bypass and determinants of early success or late favorable outcome. Experience with 1000 consecutive cases. J Cardiovasc Surg 1992;33:664-78. 20. Nevelsteen A, Wouters L, Suy R. Aortofemoral reconstruction for aortoiliac occlusive disease: a 25 year survey. Eur J Vasc Surg 19911;5:179-186. 21. DeVries SO, Hunink MG. Results of aortic bifurcation grafts for aortoiliac occlusive disease: a meta-analysis. J Vasc Surg 1997;26:558-69. 22. Rutherford RB, Baker JD, Ernst C, Johnston KW, Porter JM, Ahn S, et al. Recommended standards for report dealing with lower extremity ischemia. Revised version. J Vasc Surg 1997;26:517-38. 23. van den Akker PJ, Van Schilfgaarde R, Braud R, Van Bockel JH, Terpstra JL. Long-term success of aortoiliac operations for arteriosclerotic obstructive disease. Surg Gynecol Obstet 1992;174:485-96. 24. Valentine RJ, Hansen ME, Myers SI, Chevru A, Clagett GP. The influence of sex and aortic size in late patency after aortofemoral revascularization in young adults. J Vasc Surg 1995;21:296-306. 25. Reed AB, Conte MS, Donaldson MC, Mannick JA, Whitttemore AD, Belkin M. The impact of patient age and aortic size on the results of aortobifemoral bypass grafting. J Vasc Surg 2003;37:1219-25.
DISCUSSION Dr G. B. Zelenock (Toledo, Ohio): Dr Hans and his colleagues are to be commended for this scholarly presentation. This manuscript is carefully reported, well illustrated, very thoroughly analyzed, and it addresses a topic of considerable importance to vascular surgeons. The report carefully defines an internationally accepted classification, TASC classification, to describe and categorize the patients undergoing aortoiliac reconstruction, and it seems that the results are comparable regardless of whether they underwent endovascular or open repair except for the primary patency and shorter length of stay, which Dr Hans addressed. I would point out that their results, both open and endovascular, are among the very best reported in any published series to date, with no mortalities and very excellent limb salvage rates. So my questions are: Because this is a nonrandomized study, how did they select which of these C and D patients would actually receive a bypass versus a stenting procedure? And then, given the rapid advances in the endovascular devices and technology, and, importantly, the very much increased level of sophistication among vascular surgeons with endovascular techniques, do you think it is possible that within a few short years we will not be doing any open procedures any longer?
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Dr Sachinder S. Hans (Warren, Mich): I want to thank you for your kind comments, and I also wish to acknowledge your leadership in getting us started with the endovascular aneurysm repairs. I think your leadership provided us an incentive to perform these complex interventions. As for your questions and concerns regarding patient selection, obviously this is a nonrandomized retrospective study. Prior to the year 2000, we performed aortofemoral grafting for complex TASC C & D lesions on these patients with TASC C and D lesions. But as our experience with endovascular approach grew, and as new devices to cross chronic total occlusions became available, we became somewhat more confident, maybe sometimes somewhat foolish, but we decided to handle these complex TASC C and D lesions by endovascular approach. Now, I would say this, that these procedures can take as long as 2 to 3 hours and sometimes more, and you should be prepared to handle these complications as iliac rupture can be fatal. There are some patients that we will absolutely not consider for stenting, such as patients who have severe calcification. These lesions are difficult to dilate, and have high risk of complications, and so we prefer open bypass for long segment calcific lesions. What about the future? I think we are doing a fewer number of open aortoiliac reconstruction—at 1 time in my own years in my practice I used to do 15 or 20 aortoiliac reconstructions for occlusive disease and now I only do 2 or 3. I think the open reconstructions are here to stay for a while but many of these open reconstructions will be taken over by endovascular approach. Dr Scott A. Gruber (Detroit, Mich): I enjoyed your presentation. I have 1 question. Did any of these patients have renal insufficiency or renal failure, or could potentially be a candidate for a kidney transplant? I ask because I am concerned with all these stents being placed in the vessels that we use for transplantation, you are taking away future spots for kidneys, and so I just wanted to get your viewpoint on this. Dr Sachinder S. Hans (Warren, Mich): I think your point is well taken. We will not do this procedure in a patient with markedly elevated creatinine or one who is potentially considered for a renal transplant. The reason for that is we could end up using 200 to 300 cc of contrast in some of these patients. We do prep them with hydration and Mucomyst. Some patients do have high creatinines. But usually they are below 2 mg/dl. Some
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are between 1.5 mg/dl and 2.0 mg/dl, but the majority of these patients have normal creatinines. Dr Jean Starr (Columbus, Ohio): I would like to commend you on your results because, as you know, in this day and age when industry gives us 6-month results and sometimes up to 1-year results and sometimes other specialties not following their patients out so far, we obviously have an advantage to find surgical and endovascular patients. And 4 years is a great period of time to be able to compare these 2. And obviously those results are very, very good. I would like to ask a few technical questions. First of all, do you help decide on whether you are going to approach it endovascularly versus open based on the proximity to the calcifications in the artery and the need to place a sheath in the area or do you automatically decide to go contralateral on those? Second of all, are all of yours done with the subintimal technique where we are not truly in the lumen? I notice you are using a lot of re-entry type devices. And based on that, do you think your results could be maybe improved with using a balloon expandable stent or a covered stent graft as opposed to a self-expanding stent? Dr Sachinder S. Hans (Warren, Mich): My personal feeling is that if the lesion is above the acetabulum— that is, reconstitution of the common femoral artery—it can be handled via endovascular approach. That means you should be able to see 1 branch of the external iliac artery that is either deep epigastric or circumflex iliac. Even if you do not see those branches, the procedure can still be done as some interventionists will approach that either through the brachial artery, or the opposite groin, or with a combined brachial/ femoral approach, so that would be our choice. My limit would be that if the lesion extends beyond the acetabulum I would probably be reluctant to do that endovascularly. As far as your second question is concerned, even if you are subintimal, you should try to maneuver the guidewire back into the true lumen, but do not deploy a stent until you confirm that you are in the true lumen. And your question regarding stent grafts. I have only used stent graft in only 1 patient, although there is a series from Dartmouth where they have exclusively used stent grafts. But my own feeling is that the majority of these patients can be treated with either balloon expandable stents for the lesions at the mouth of the common iliac arteries or self-expanding stents as you go down to the external iliac arteries.