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Endovascular treatment of TransAtlantic Inter-Society Consensus D aortoiliac occlusive disease using unibody bifurcated endografts
Endovascular treatment of TransAtlantic Inter-Society Consensus D aortoiliac occlusive disease using unibody bifurcated endografts Robert M. Van Haren, MD, MSPH, Lee J. Goldstein, MD, Omaida C. Velazquez, MD, Jagajan Karmacharya, MD, and Arash Bornak, MD, Miami, Fla
ABSTRACT Objective: Aortobifemoral bypass has been the gold standard treatment for extensive aortoiliac occlusive disease. Endovascular therapy and stenting of aortic and iliac occlusive lesions has proven to be efficacious, especially when dealing with short segment lesions. Endovascular treatment of TransAtlantic Inter-Society Consensus II (TASC) D aortoiliac occlusive lesions remains a challenge, but a valuable treatment option in poor surgical candidates. We present our operative technique and midterm results in treating TASC D aortoiliac occlusive disease using unibody bifurcated endografts. Methods: We performed a retrospective review of patients with TASC D aortoiliac occlusive disease who underwent transfemoral endovascular revascularization with the Endologix Powerlink unibody bifurcated endograft (Endologix, Irvine, Calif). Demographic data, operative details, and outcomes were collected. Paired t-tests were performed to compare preoperative and postoperative ankle brachial indexes. Results: Between March 2009 and July 2011, 10 high-risk patients (8 male and 2 female) for a traditional aortobifemoral bypass were treated using this endovascular technique. The mean age was 59 6 6 years (range, 50-69 years). All patients presented with rest pain, and four with tissue loss. Technical success was 100%, with two patients requiring brachial access and eight patients requiring additional stent placement. Postoperatively, all patients reported clinical improvement with resolution of ischemic symptoms. Mean improvement ankle brachial index was 0.50 6 0.08 (P ¼ .028) and 0.50 6 0.01 (P ¼ .034) in the left and right legs, respectively. Mean follow-up time was 40 6 24 months (range, 4-81 months). The primary and secondary patency rates were 80% and 100%, respectively. Complications requiring early reintervention occurred in two patients and included one expanding hematoma from the percutaneous access site and one acute iliac artery thrombosis. Additionally, one patient underwent repeat angioplasty/stenting for threatened endograft limbs at 4 months. One patient expired during follow-up from an unrelated cardiac cause 19 weeks postoperatively. Conclusions: This series demonstrates that endovascular repair using a unibody bifurcated endograft for TASC D aortoiliac occlusive disease is feasible, effective, and has excellent midterm patency. It should be considered an effective treatment option when the disease process involves the aorta, in particular if the patient is surgically unfit for a traditional aortobifemoral bypass. The unibody configuration preserves the anatomic aortic bifurcation, which is particularly important in patients with peripheral occlusive disease who are deemed to undergo subsequent endovascular interventions. (J Vasc Surg 2016;-:1-8.)
Aortoiliac occlusive disease and associated Leriche syndrome classically present with a triad of symptoms, claudication, decreased femoral pulses, and impotence. It occurs in men and women generally between the ages of 40 and 60 years, and is usually the result of chronic atherosclerotic occlusive disease.1 The TransAtlantic Inter-Society Consensus for the From the Vascular and Endovascular Surgery, University of Miami Miller School of Medicine. Author conflict of interest: L.J.G. has been paid a consulting fee by Endologix. Correspondence: Arash Bornak, MD, Vascular and Endovascular Surgery, University of Miami Miller School of Medicine, 1295 NW 14th St, University of Miami Hospital, South Building, Ste J, Miami, FL 33125 (e-mail: abornak@ med.miami.edu). The editors and reviewers of this article have no relevant financial relationships to disclose per the JVS policy that requires reviewers to decline review of any manuscript for which they may have a conflict of interest. 0741-5214 Published by Elsevier Inc. on behalf of the Society for Vascular Surgery. http://dx.doi.org/10.1016/j.jvs.2016.08.084
Management of Peripheral Artery Disease (TASC II) classifies combined aortic and iliac occlusive pattern as type D lesions.2 TASC II favors open surgery for these extensive lesions, stating that endovascular treatment does not produce satisfactory results. Aortobifemoral bypass is considered the gold standard of repair with patency of 90% at 5 years and 75% at 10 years.3 Aortobifemoral bypass has a 3% to 8% mortality and 10% morbidity with complications such as graft failure (3%) and graft infection (1%).4 Another surgical option is extra-anatomic (ie, axillobifemoral) bypass grafting. Endovascular therapy has expanded into the treatment of aortoiliac occlusive disease, and may be well-suited for high-risk surgery patients who would not tolerate an open aortic procedure.5-7 The “kissing stents” technique for aortoiliac lesions is well described with a midterm primary patency rate of 84% to 92% using covered stents.8-10 Primary patency rates are slightly lower than open surgery, but reintervention can be achieved 1
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percutaneously and result in secondary patency rates similar to open surgery.11 These data suggest acceptable results for endovascular treatment of aortoiliac occlusive disease. Endovascular stent graft technology, originally designed for the treatment of aortic aneurysm disease, has been previously applied to aortoiliac occlusive disease with acceptable outcomes. This report reviews long-term outcomes using a bifurcated unibody endograft, the Powerlink endograft (Endologix, Irvine, Calif), in type D aortoiliac occlusive lesions.
METHODS A retrospective review was performed on 10 patients with symptomatic aortoiliac TASC D occlusive lesions who underwent endovascular treatment with unibody bifurcated endografts between March 2009 and July 2011. In comparison, during the study period, 24 patients underwent aortobifemoral bypass and 15 patients underwent endovascular kissing iliac stents. This was an offlabel use of the device, and all subjects gave informed consent for the procedure. Institutional review board approval was obtained for this retrospective review. Patient information including demographic data, medical history, imaging results, operative details, complications, and patency were collected from the medical records and compiled into a database for analysis. All patients underwent a preoperative computed tomography angiography (CTA) as part of the operative planning. They were followed postoperatively with CTA and/or color duplex ultrasound imaging with ankle-brachial index (ABI) measurement. Follow-up CTA was obtained when aneurysm was present. Technical success was defined as effectively reestablishing uninterrupted flow from the aorta to both external iliac arteries. A complication was defined as any event after the procedure requiring reoperation, as well as significant morbidity, or mortality. An improvement in Rutherford classification was considered a clinical improvement. Improvement in ABI was defined as an increase of >0.2 from preoperative measurement. Variables are presented as mean values 6 standard deviation. A paired two-sided t-test was performed to compare mean preoperative ABI to mean postoperative ABI in both limbs. Patients without both preoperative and postoperative ABIs were excluded from the paired t-test ABI analysis. However, they were still included in the manuscript and included in all other outcome analyses. P < .05 was considered significant. Endovascular procedure. All procedures were performed under general anesthesia. Bilateral common femoral artery access was obtained either percutaneously with ultrasound guidance (five cases) or through an open femoral surgical approach (five cases). In two cases, brachial artery access was obtained because the
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Table I. Operative techniques Characteristics General anesthesia
Mean 6 SD or No. 10
Percutaneous
5
Brachial access
2
Blood loss, mL
490 6 480
Operative time, minutes
290 6 110
Proximal cuff Additional distal stents
7 2.0 6 2.5
SD, Standard deviation.
aortic occlusion could not be crossed by a retrograde approach (Table I; Fig 1, a and b). In the remainder of cases the occlusion was crossed by a bilateral retrograde approach. After crossing bilateral iliac arteries, the contralateral limb wire was snared and brought over the aortic bifurcation. Under fluoroscopic guidance, the unibody endograft was placed into the aorta and brought down to rest at the aortic bifurcation. Before endograft insertion, to create sufficient lumen for at least partial endograft deployment, iliac and aortic occlusions were either predilated using an endograft sheath and dilator, and/or using high-pressure balloons 7 to 16 mm (Fig 2, a-c), this was confirmed by angiography. Alternatively, when common iliac arteries (CIAs) were extremely calcified and responding poorly to angioplasty, iCast balloon-mounted stents (Atrium, Hudson, NH) were initially deployed in the CIAs creating a landing zone, then the endograft was advanced, positioned, and deployed (Fig 3). After deployment, the endograft was postdilated with a Coda balloon (Cook, Bloomingdale, Ind) or with high-pressure balloons (Fig 4, a-c). If the occlusive lesion extended beyond the unibody bifurcated graft, extension cuffs were placed proximally (Fig 5, a-c) and distally as needed. Typically distal extensions utilized iCast stents (Atrium) (Fig 6, a and b) in the distal CIAs and self-expandable bare metal or covered stents in the external iliac arteries. Completion angiography (Fig 7) was performed to document successful revascularization and to detect any procedural complications, such as distal embolization, vessel dissection, or vessel rupture.
RESULTS The average age of patients treated was 59 6 6 years (range, 50-69 years). These patients were not considered good candidates for open aortic surgery owing to their medical comorbidities and/or previous abdominal surgery. Table II displays the patients’ demographic data. The indication for surgery was the presence of ischemic rest pain, Rutherford category 4 in six patients. The remaining four patients presented with tissue loss (Rutherford category 5).
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Fig 1. a and b, Angiography demonstrating complete aortoiliac occlusion. Bilateral external and internal iliac arteries are patent.
Fig 2. Delivery of the endograft after predilation of the aortoiliac occlusion with sheath and dilator (a and b) and/or high-pressure balloons (c).
All patients had TASC D aortoiliac occlusive lesions with aortic involvement (occlusive or aneurysmal/ectatic). Four patients had complete aortic occlusion. This included one juxtarenal ectatic aortic occlusion, which required additional protective renal artery stenting. Two
patients had severe aortic stenosis, both with a unilateral iliac artery occlusion and contralateral iliac artery stenosis. Five patients had coexisting abdominal aortic aneurysm or ectasia with complete occlusion of CIAs, out of which four were unilateral occlusions and one was bilateral.
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Fig 3. iCast (icast) stent deployment in the left CIA to create a landing zone for the endograft (E).
The mean aortic diameter for all patients was 3.3 6 1.4 cm (range, 2.0-6.4 cm). The indication for treatment was occlusive disease; all patients had rest pain or tissue loss. Two patients also had additional indication for repair based on aortic aneurysm diameter. Technical success was achieved in all cases by re-establishing uninterrupted flow from the aorta to both external iliac arteries. The average operative time was 290 6 110 minutes (range, 205-569 minutes). Proximal cuff was used in seven patients (six infrarenal, one suprarenal), including all treated aneurysms. The average additional number of stents required distally was 2.0 6 2.5. Five patients required external iliac artery stent placement for residual stenosis or occlusion extending from the CIA to the external iliac artery: one had a bare metal self-expandable stent for residual stenosis and the remaining four had covered self-expandable stents (Viabahn; W. L. Gore & Associates, Flagstaff, Ariz) for occlusion. One patient had juxtarenal aortic occlusion and required protective renal artery stent placement. One patient had placement of a Palmaz stent inside the endograft trunk for maximal aortic luminal gain. The estimated blood loss was 490 6 480 mL (range, 100-1500 mL). The average hospital length of stay was 6.5 6 6 nights (range, 1-18 nights). During the entire follow-up period, primary and secondary patency rates were 80% and 100%, respectively.
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This included one patient with an early iliac artery thrombosis requiring reintervention and a second patient with threatened iliac endograft limbs during follow-up (described elsewhere in this article). There was no distal embolization, major or minor amputation, or graft infection. There was one case of expanding hematoma at a percutaneous access site. On postoperative day 1, the patient had an expanding hematoma at the percutaneous access site. He returned to the operating room and was found to have failure of the common femoral percutaneous closure. The common femoral artery was repaired with a saphenous vein patch. In the second complicated case, shortly after surgery, the patient developed acute left leg ischemia. The patient was taken back to the operating room and was found to have acute thrombosis of the left external iliac, common femoral, and superficial femoral arteries. Balloon thrombectomy and endarterectomy were performed, followed by closure with a bovine patch angioplasty. The occlusion was felt to be secondary to poor femoral outflow. Both of these patients had prolonged hospital courses, 18 and 12 nights, respectively, but did not suffer other complications. One patient required reintervention 4 months postoperatively after reporting worsening claudication after initial improvement. CTA demonstrated patent endograft and stenosis near the end of endograft limbs in the mid-CIA bilaterally. Additionally, there was stenosis of the mid common femoral artery access site. Bilateral iliac angioplasty and stenting (iCast; Atrium) was performed, as well as left common femoral endarterectomy and patch plasty. One death was reported 135 days postoperatively, and was unrelated to the surgical procedure. The patient experienced an exacerbation of congestive heart failure. The average follow up time was 40 6 24 months (range, 4-81 months). One patient was lost to follow-up after 4 months. At the most recent clinic visit, all patients demonstrated sustained clinical improvement of ischemic symptoms with complete resolution of their ischemic rest pain. Five patients had both pre and postoperative ABI testing. The mean preoperative ABI was 0.42 6 0.22 and 0.41 6 0.08 in the left and right legs, respectively. The mean postoperative ABI was 0.95 6 0.25 and 1.00 6 0.12 in the left and right legs, respectively. The mean improvement of ABIs was 0.50 6 0.15 and 0.59 6 0.15 in the left and right legs, respectively. All patients had a bilateral improvement in the ABI of >0.2, except for one patient where the ABI improved by 0.16 (preoperative 0.67 to postoperative 0.83). Paired twosided t-tests demonstrated statistical significance in the left leg (P ¼ .012) and right leg (P ¼ .002).
DISCUSSION Endovascular treatment of TASC D aortoiliac lesions has expanded rapidly in recent years. Our experience with
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Fig 4. a, The endograft is first deployed (de), then (b) postdeployment dilatation with the (c) Coda balloon (C), which allows full endograft expansion.
Fig 5. a, Proximal aortic stenosis (ps) is still present. b and c, Proximal endograft (pe) extension for the treatment of residual aortic stenosis.
endovascular unibody bifurcated endografts demonstrates excellent technical success, long-term patency, and limited complications. We believe the complication rate will decrease with increased technical experience and improved patient selection. Several papers have reported satisfactory results with endovascular treatment of aortoiliac lesions.12 Krankenberg et al13 reported a series of 11 patients with
complete occlusion of the aortoiliac bifurcation. Endovascular revascularization was achieved with transfemoral balloon angioplasty and selective stent placement in the distal aorta. The iliac arteries were treated with ninitol stents, and postdilated with kissing balloons through a bilateral femoral artery approach. Successful bilateral endovascular stent placement was performed in eight patients (73%) and the remaining three patients underwent
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Fig 6. a and b, Distal extension beyond the left endograft limb (limb) with an iCast (iCast) stent for the treatment of the distal CIA stenosis.
Fig 7. Completion angiography.
successful unilateral stent placement (27%).13 There was one case of acute thrombosis intraoperatively managed by thrombolysis. One patient had unilateral endovascular success and required femorofemoral crossover bypass grafting. At 14 months, there was significant improvement in the ABI and claudication. A similar technique was used in another series of 49 patients with infrarenal aortic occlusion. Again, predilation angioplasty of the aortic lesion was followed by stent placement, and iliac lesions were managed with stents and kissing balloons. Technical success was achieved in 40 patients (81.6%) and there were complications in 8 patients (16.3%). At 1 year, the primary patency rate was 88.4%; at 3 years it was 80.1%. During the study period, five patients required repeat endovascular intervention and two patients required bypass surgery (total of seven patients [17.5%]).14 Sharafuddin et al15 performed a retrospective review of 66 patients who underwent kissing stent reconstruction for aortoiliac occlusive disease (TASC A, B, C, and D lesions). Variables associated with restenosis were radial mismatch (dead space in the aortic lumen around a protruding segment of the stent), female gender, prior occlusion, and residual stenosis.15 Failure of endovascular treatment is a concern, especially if it complicates a secondary open operation. However, Danczyk et al16 demonstrated that failed endovascular therapy for
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Table II. Patient demographic information Characteristics Age, years
Mean 6 SD or No. 59 6 6
Gender, M/F
8/2
Hypertension
10
Hyperlipidemia
7
Smoking history
10
Chronic obstructive pulmonary disease
8
Previous myocardial infarction
1
Congestive heart failure
2
Ejection fraction
50 6 16
Rutherford category 4
6
Rutherford category 5
4
SD, Standard deviation.
aortoiliac occlusive disease will not result in a worse outcome if secondary open surgery is required. Similar to our technique, the use of bifurcated aortic grafts has been reported in a series of 14 patients with TASC C and TASC D aortoiliac lesions. The alternate technique involved a two-step procedure. First, the occlusive lesion was crossed and a 24-hour catheterdirected intra-arterial fibrinolysis was performed with an open-ended perfusion wire (Medtronic Vascular, Danvers, Mass). Next, a balloon angioplasty of the lesions was performed followed by placement of an Excluder endograft (W. L. Gore & Associates). Technical success was achieved in all patients (100%). Two patients (14%) developed unilateral occlusions that were treated with intra-arterial fibrinolysis. At 62 months, the primary patency rate was 85.7%.17 Endografts are used in the treatment of aneurysmal disease; however, their off-label use in the treatment of aortoiliac occlusive disease has only recently been reported.17 The use of covered stents is hypothesized to decrease restenosis by providing a barrier to the ingrowth of neointimal hyperplasia.18 Sabri et al8 compared patency rates between covered and bare metal stents in a retrospective review of 54 patients with aortoiliac occlusive disease. The primary patency rate for covered stents was 92% as compared with 62% for balloon-expandable bare metal stents (follow-up of 29.5 months). Mwipatayi et al10 also demonstrated superior patency rates with covered stents compared with bare metal stents for treatment of aortoiliac occlusive disease. The advantage of covered stents was most evident in patients with TASC D aortoiliac occlusive disease. Our experience supports the endovascular management of TASC D aortoiliac lesions with unibody bifurcated endografts. This unique configuration preserves the aortic bifurcation for subsequent peripheral interventions and is ideal for the treatment of extensive aortic and aortic bifurcation occlusive disease. The covered
nature of these grafts decreases the risk of bleeding if arteries rupture, and provides improved patency compared with bare metal stents.10,19 We initially started using this technique for patients with iliac occlusion and ectatic/aneurysmal aorta. Given our initial technical success, we began using it for only occlusive disease in select patients. We continue to perform the procedure in high-risk patients with occlusive disease involving the aorta in particular. The manufacturer’s Instructions for Use states, “vessels that are significantly calcified, occlusive, tortuous or thrombus-lined may preclude placement of the endovascular graft and/or may increase the risk of embolization.” In off-label use, patient selection is of paramount importance for technical success. The low radial force of the unibody endograft does not preclude its deployment, the graft responds well to postdilation, and if necessary the addition of a balloon-expandable stent such as a Palmaz stent can reinforce inside the endograft for maximal luminal gain in the aorta. However, based on our experience, we believe that patients with very tortuous occluded iliac arteries, and extensive occlusive calcifications of aortoiliac arteries combined with small aortoiliac diameter are not good candidates for this approach. Placement of the device requires that it be advanced into the aorta via a femoral approach, the wire to the contralateral limb is snared, and then the device is pulled down to the aortic bifurcation, with each limb being moved distally in the iliac artery. Bulky occluded aorta with extensive calcification may not respond to a minimum predilation, preventing this maneuver and partial endograft deployment. The graft may become trapped with no “bailout.” Postdilation angiography assesses that minimal luminal gain necessary for endograft positioning and full or partial deployment. Presence of an ectatic or aneurysmal abdominal aorta in TASC D aortoiliac occlusion actually simplifies graft deployment. Occlusion in the iliac arteries not responding to predilation should be stented with balloon-expandable stents to secure a good landing zone for the endograft. Tortuous calcified iliac artery occlusion makes recanalization technically difficult and may also result in endograft iliac limb kinking. Crossing iliac artery occlusions subintimally may be a limiting factor: If the iliac artery does not respond to predilation and/or stenting before endograft deployment, the endograft limb can occlude. This was not a problem in our patients. Another concern with a subintimal plane is iliac rupture, which would be visible on postdilation angiography. Again, we did not encounter this problem but the endograft fabric limits the risk of hemorrhage in case of rupture. We typically used a small diameter (22 mm) endograft. The endograft has an endoskeleton, and infolding is not a major concern. Despite its poor radial force, the endograft adapts well to even a small diameter aorta after balloon angioplasty.
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The endograft is costly and should be used selectively. In many cases a kissing stent technique is significantly more cost effective. Based on our experience, we favor now the use of unibody bifurcated endografts when (1) preservation of the aortic bifurcation is important, for example, in patients with infrainguinal occlusive disease who may need future extremity revascularization, and/or (2) in TASC D lesions with significant aortic involvement (occlusive or aneurysmal). The endgraft allows full coverage of the stenotic/occlusive aorta with maximum luminal gain. Endologix manufactures now an endograft with a short main body trunk of 40 mm with a 22-mm diameter, very helpful in aortic bifurcation and distal aortic occlusions. Optimizing the iliofemoral outflow is a key component of long-term success and every effort should be made to avoid and/or identify potential iliac or femoral artery stenosis during intervention and follow-up and prevent iliac limb thrombosis. Patients should be warned of early symptoms of recurrent claudication and appropriate noninvasive imaging should be obtained. There are several limitations to our study. It is a single institution retrospective review, and included a small sample size owing to the novelty of the technique.
3. 4.
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8.
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CONCLUSIONS This paper demonstrates that unibody bifurcated endografts used in the treatment of TASC D aortoiliac occlusive disease are safe, effective, and in our opinion most beneficial when aortic involvement is present. The unibody configuration preserves the anatomic aortic bifurcation, which is particularly important in patients with peripheral occlusive disease who are deemed to undergo subsequent endovascular interventions. The technical success has been good and midterm patency rates promising. We believe that procedural complications can gradually be reduced with adequate preoperative planning, increased experience with the technique, and improved patient selection.
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AUTHOR CONTRIBUTIONS Conception and design: RV, LG, OV, JK, AB Analysis and interpretation: RV, LG, AB Data collection: RV, LG, OV, JK, AB Writing the article: RV, LG, AB Critical revision of the article: LG, AB Final approval of the article: RV, LG, OV, JK, AB Statistical analysis: RV Obtained funding: Not applicable Overall responsibility: AB
REFERENCES 1. Erskine JM, Gerbode FL, French SW, Hood RM. Surgical treatment of thrombotic occlusion of aorta and iliac arteries; the Leriche syndrome. AMA Arch Surg 1959;79:85-93. 2. Norgren L, Hiatt WR, Dromandy JA, Nehler MR, Harris KA, Fowkes FG, et al. Inter-Society Consensus for the
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Management of Peripheral Arterial Disease (TASC II). J Vasc Surg 2007;45:S5-67. Rutherford RB. Aortobifemoral bypass, the gold standard: technical considerations. Semin Vasc Surg 1994;7:11-6. Szilagyi DE, Elliot JP, 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. Moise MA, Kashyap VS. Treatment of aortoiliac occlusive disease: medical versus endovascular versus surgical therapy. Curr Treat Options Cardiovasc Med 2011;13:114-28. Schmalstieg J, Zeller T, Tubler T, et al. Long term data of endovascularly treated patients with severe and complex aortoiliac occlusive disease. J Cardiovasc Surg (Torino) 2012;53:291-300. Indes JE, Tuggle CT, Mandawat A, Muhs BE, Sosa JA. Effect of physician and hospital experience on patient outcomes for endovascular treatment of aortoiliac occlusive disease. Arch Surg 2011;146:966-71. Sabri SS, Choudhri A, Orgera G, Arslan B, Turba UC, Harthun NL, et al. Outcomes of covered kissing stent placement compared with bare metal stent placement in the treatment of atherosclerotic occlusive disease at the aortic bifurcation. J Vasc Interv Radiol 2010;21:995-1003. Moise MA, Alvarez-Tostado JA, Clair DG, Greenberg RK, Lyden SP, Srivastava SD, et al. Endovascular management of chronic infrarenal aortic occlusion. J Endovasc Ther 2009;16: 84-92. Mwipatayi BP, Thomas S, Wong J, Temple SE, Vijayan V, Jackson M, et al. A comparison of covered vs bare expandable stents for the treatment of aortoiliac occlusive disease. J Vasc Surg 2011;54:1561-70. Jongkind V, Akkersdijk GJ, Yeung KK, Wisselink W. A systematic review of endovascular treatment of extensive aortoiliac occlusive disease. J Vasc Surg 2010;52:1376-83. Kashyap VS, Pavkov ML, Bena JF, Sarac TP, O’Hara PJ, Lyden SP, et al. The management of severe aortoiliac occlusive disease: endovascular therapy rivals open reconstruction. J Vasc Surg 2008;48:1451-7. Krankenberg H, Schluter M, Schwencke C, Walter D, Pascotto A, Sandstede J, et al. Endovascular reconstruction of the aortic bifurcation in patients with Leriche syndrome. Clin Res Cardiol 2009;98:657-64. Kim TH, Ko YG, Kim U, Kim JS, Choi D, Hong MK, et al. Outcomes of endovascular treatment of chronic total occlusion of the infrarenal aorta. J Vasc Surg 2011;53:1542-9. Sharafuddin MJ, Hoballah JJ, Kresowik TF, et al. Long-term outcome following stent reconstruction of the aortic bifurcation and the role of geometric determinants. Ann Vasc Surg 2008;22:346-57. Danczyk RC, Mitchell EL, Petersen BD, Sharp WJ, Golzarian J, Sun S, et al. Outcomes of open operation for aortoiliac occlusive disease after failed endovascular therapy. Arch Surg 2012;147:841-5. Zander T, Blasco O, Rabellino M, Baldi S, Sanabria E, Llorens R, et al. Bifurcated endograft in aortoiliac type C and D lesions: long-term results. J Vasc Interv Radiol 2011;22:1124-30. Gilbertson JJ, Pettengill OS, Cronenwett JL. Antiproliferative effect of heparin on human smooth muscle cells cultured from intimal hyperplastic lesions of vein grafts. Ann Vasc Surg 1992;6:265-71. Chang RW, Goodney PP, Baek JH, Nolan BW, Rzucidlo EM, Powell RJ. Long-term results of combined common femoral endarterectomy and iliac stenting/stent grafting for occlusive disease. J Vasc Surg 2008;48:362-7.
Submitted Apr 21, 2016; accepted Aug 3, 2016.
ABSTRACT Objective: Aortobifemoral bypass has been the gold standard treatment for extensive aortoiliac occlusive disease. Endovascular therapy and stenting of aortic and iliac occlusive lesions has proven to be efficacious, especially when dealing with short segment lesions. Endovascular treatment of TransAtlantic Inter-Society Consensus II (TASC) D aortoiliac occlusive lesions remains a challenge, but a valuable treatment option in poor surgical candidates. We present our operative technique and midterm results in treating TASC D aortoiliac occlusive disease using unibody bifurcated endografts. Methods: We performed a retrospective review of patients with TASC D aortoiliac occlusive disease who underwent transfemoral endovascular revascularization with the Endologix Powerlink unibody bifurcated endograft (Endologix, Irvine, Calif). Demographic data, operative details, and outcomes were collected. Paired t-tests were performed to compare preoperative and postoperative ankle brachial indexes. Results: Between March 2009 and July 2011, 10 high-risk patients (8 male and 2 female) for a traditional aortobifemoral bypass were treated using this endovascular technique. The mean age was 59 6 6 years (range, 50-69 years). All patients presented with rest pain, and four with tissue loss. Technical success was 100%, with two patients requiring brachial access and eight patients requiring additional stent placement. Postoperatively, all patients reported clinical improvement with resolution of ischemic symptoms. Mean improvement ankle brachial index was 0.50 6 0.08 (P ¼ .028) and 0.50 6 0.01 (P ¼ .034) in the left and right legs, respectively. Mean follow-up time was 40 6 24 months (range, 4-81 months). The primary and secondary patency rates were 80% and 100%, respectively. Complications requiring early reintervention occurred in two patients and included one expanding hematoma from the percutaneous access site and one acute iliac artery thrombosis. Additionally, one patient underwent repeat angioplasty/stenting for threatened endograft limbs at 4 months. One patient expired during follow-up from an unrelated cardiac cause 19 weeks postoperatively. Conclusions: This series demonstrates that endovascular repair using a unibody bifurcated endograft for TASC D aortoiliac occlusive disease is feasible, effective, and has excellent midterm patency. It should be considered an effective treatment option when the disease process involves the aorta, in particular if the patient is surgically unfit for a traditional aortobifemoral bypass. The unibody configuration preserves the anatomic aortic bifurcation, which is particularly important in patients with peripheral occlusive disease who are deemed to undergo subsequent endovascular interventions. (J Vasc Surg 2016;-:1-8.)
Aortoiliac occlusive disease and associated Leriche syndrome classically present with a triad of symptoms, claudication, decreased femoral pulses, and impotence. It occurs in men and women generally between the ages of 40 and 60 years, and is usually the result of chronic atherosclerotic occlusive disease.1 The TransAtlantic Inter-Society Consensus for the From the Vascular and Endovascular Surgery, University of Miami Miller School of Medicine. Author conflict of interest: L.J.G. has been paid a consulting fee by Endologix. Correspondence: Arash Bornak, MD, Vascular and Endovascular Surgery, University of Miami Miller School of Medicine, 1295 NW 14th St, University of Miami Hospital, South Building, Ste J, Miami, FL 33125 (e-mail: abornak@ med.miami.edu). The editors and reviewers of this article have no relevant financial relationships to disclose per the JVS policy that requires reviewers to decline review of any manuscript for which they may have a conflict of interest. 0741-5214 Published by Elsevier Inc. on behalf of the Society for Vascular Surgery. http://dx.doi.org/10.1016/j.jvs.2016.08.084
Management of Peripheral Artery Disease (TASC II) classifies combined aortic and iliac occlusive pattern as type D lesions.2 TASC II favors open surgery for these extensive lesions, stating that endovascular treatment does not produce satisfactory results. Aortobifemoral bypass is considered the gold standard of repair with patency of 90% at 5 years and 75% at 10 years.3 Aortobifemoral bypass has a 3% to 8% mortality and 10% morbidity with complications such as graft failure (3%) and graft infection (1%).4 Another surgical option is extra-anatomic (ie, axillobifemoral) bypass grafting. Endovascular therapy has expanded into the treatment of aortoiliac occlusive disease, and may be well-suited for high-risk surgery patients who would not tolerate an open aortic procedure.5-7 The “kissing stents” technique for aortoiliac lesions is well described with a midterm primary patency rate of 84% to 92% using covered stents.8-10 Primary patency rates are slightly lower than open surgery, but reintervention can be achieved 1
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percutaneously and result in secondary patency rates similar to open surgery.11 These data suggest acceptable results for endovascular treatment of aortoiliac occlusive disease. Endovascular stent graft technology, originally designed for the treatment of aortic aneurysm disease, has been previously applied to aortoiliac occlusive disease with acceptable outcomes. This report reviews long-term outcomes using a bifurcated unibody endograft, the Powerlink endograft (Endologix, Irvine, Calif), in type D aortoiliac occlusive lesions.
METHODS A retrospective review was performed on 10 patients with symptomatic aortoiliac TASC D occlusive lesions who underwent endovascular treatment with unibody bifurcated endografts between March 2009 and July 2011. In comparison, during the study period, 24 patients underwent aortobifemoral bypass and 15 patients underwent endovascular kissing iliac stents. This was an offlabel use of the device, and all subjects gave informed consent for the procedure. Institutional review board approval was obtained for this retrospective review. Patient information including demographic data, medical history, imaging results, operative details, complications, and patency were collected from the medical records and compiled into a database for analysis. All patients underwent a preoperative computed tomography angiography (CTA) as part of the operative planning. They were followed postoperatively with CTA and/or color duplex ultrasound imaging with ankle-brachial index (ABI) measurement. Follow-up CTA was obtained when aneurysm was present. Technical success was defined as effectively reestablishing uninterrupted flow from the aorta to both external iliac arteries. A complication was defined as any event after the procedure requiring reoperation, as well as significant morbidity, or mortality. An improvement in Rutherford classification was considered a clinical improvement. Improvement in ABI was defined as an increase of >0.2 from preoperative measurement. Variables are presented as mean values 6 standard deviation. A paired two-sided t-test was performed to compare mean preoperative ABI to mean postoperative ABI in both limbs. Patients without both preoperative and postoperative ABIs were excluded from the paired t-test ABI analysis. However, they were still included in the manuscript and included in all other outcome analyses. P < .05 was considered significant. Endovascular procedure. All procedures were performed under general anesthesia. Bilateral common femoral artery access was obtained either percutaneously with ultrasound guidance (five cases) or through an open femoral surgical approach (five cases). In two cases, brachial artery access was obtained because the
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Table I. Operative techniques Characteristics General anesthesia
Mean 6 SD or No. 10
Percutaneous
5
Brachial access
2
Blood loss, mL
490 6 480
Operative time, minutes
290 6 110
Proximal cuff Additional distal stents
7 2.0 6 2.5
SD, Standard deviation.
aortic occlusion could not be crossed by a retrograde approach (Table I; Fig 1, a and b). In the remainder of cases the occlusion was crossed by a bilateral retrograde approach. After crossing bilateral iliac arteries, the contralateral limb wire was snared and brought over the aortic bifurcation. Under fluoroscopic guidance, the unibody endograft was placed into the aorta and brought down to rest at the aortic bifurcation. Before endograft insertion, to create sufficient lumen for at least partial endograft deployment, iliac and aortic occlusions were either predilated using an endograft sheath and dilator, and/or using high-pressure balloons 7 to 16 mm (Fig 2, a-c), this was confirmed by angiography. Alternatively, when common iliac arteries (CIAs) were extremely calcified and responding poorly to angioplasty, iCast balloon-mounted stents (Atrium, Hudson, NH) were initially deployed in the CIAs creating a landing zone, then the endograft was advanced, positioned, and deployed (Fig 3). After deployment, the endograft was postdilated with a Coda balloon (Cook, Bloomingdale, Ind) or with high-pressure balloons (Fig 4, a-c). If the occlusive lesion extended beyond the unibody bifurcated graft, extension cuffs were placed proximally (Fig 5, a-c) and distally as needed. Typically distal extensions utilized iCast stents (Atrium) (Fig 6, a and b) in the distal CIAs and self-expandable bare metal or covered stents in the external iliac arteries. Completion angiography (Fig 7) was performed to document successful revascularization and to detect any procedural complications, such as distal embolization, vessel dissection, or vessel rupture.
RESULTS The average age of patients treated was 59 6 6 years (range, 50-69 years). These patients were not considered good candidates for open aortic surgery owing to their medical comorbidities and/or previous abdominal surgery. Table II displays the patients’ demographic data. The indication for surgery was the presence of ischemic rest pain, Rutherford category 4 in six patients. The remaining four patients presented with tissue loss (Rutherford category 5).
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Fig 1. a and b, Angiography demonstrating complete aortoiliac occlusion. Bilateral external and internal iliac arteries are patent.
Fig 2. Delivery of the endograft after predilation of the aortoiliac occlusion with sheath and dilator (a and b) and/or high-pressure balloons (c).
All patients had TASC D aortoiliac occlusive lesions with aortic involvement (occlusive or aneurysmal/ectatic). Four patients had complete aortic occlusion. This included one juxtarenal ectatic aortic occlusion, which required additional protective renal artery stenting. Two
patients had severe aortic stenosis, both with a unilateral iliac artery occlusion and contralateral iliac artery stenosis. Five patients had coexisting abdominal aortic aneurysm or ectasia with complete occlusion of CIAs, out of which four were unilateral occlusions and one was bilateral.
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Fig 3. iCast (icast) stent deployment in the left CIA to create a landing zone for the endograft (E).
The mean aortic diameter for all patients was 3.3 6 1.4 cm (range, 2.0-6.4 cm). The indication for treatment was occlusive disease; all patients had rest pain or tissue loss. Two patients also had additional indication for repair based on aortic aneurysm diameter. Technical success was achieved in all cases by re-establishing uninterrupted flow from the aorta to both external iliac arteries. The average operative time was 290 6 110 minutes (range, 205-569 minutes). Proximal cuff was used in seven patients (six infrarenal, one suprarenal), including all treated aneurysms. The average additional number of stents required distally was 2.0 6 2.5. Five patients required external iliac artery stent placement for residual stenosis or occlusion extending from the CIA to the external iliac artery: one had a bare metal self-expandable stent for residual stenosis and the remaining four had covered self-expandable stents (Viabahn; W. L. Gore & Associates, Flagstaff, Ariz) for occlusion. One patient had juxtarenal aortic occlusion and required protective renal artery stent placement. One patient had placement of a Palmaz stent inside the endograft trunk for maximal aortic luminal gain. The estimated blood loss was 490 6 480 mL (range, 100-1500 mL). The average hospital length of stay was 6.5 6 6 nights (range, 1-18 nights). During the entire follow-up period, primary and secondary patency rates were 80% and 100%, respectively.
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This included one patient with an early iliac artery thrombosis requiring reintervention and a second patient with threatened iliac endograft limbs during follow-up (described elsewhere in this article). There was no distal embolization, major or minor amputation, or graft infection. There was one case of expanding hematoma at a percutaneous access site. On postoperative day 1, the patient had an expanding hematoma at the percutaneous access site. He returned to the operating room and was found to have failure of the common femoral percutaneous closure. The common femoral artery was repaired with a saphenous vein patch. In the second complicated case, shortly after surgery, the patient developed acute left leg ischemia. The patient was taken back to the operating room and was found to have acute thrombosis of the left external iliac, common femoral, and superficial femoral arteries. Balloon thrombectomy and endarterectomy were performed, followed by closure with a bovine patch angioplasty. The occlusion was felt to be secondary to poor femoral outflow. Both of these patients had prolonged hospital courses, 18 and 12 nights, respectively, but did not suffer other complications. One patient required reintervention 4 months postoperatively after reporting worsening claudication after initial improvement. CTA demonstrated patent endograft and stenosis near the end of endograft limbs in the mid-CIA bilaterally. Additionally, there was stenosis of the mid common femoral artery access site. Bilateral iliac angioplasty and stenting (iCast; Atrium) was performed, as well as left common femoral endarterectomy and patch plasty. One death was reported 135 days postoperatively, and was unrelated to the surgical procedure. The patient experienced an exacerbation of congestive heart failure. The average follow up time was 40 6 24 months (range, 4-81 months). One patient was lost to follow-up after 4 months. At the most recent clinic visit, all patients demonstrated sustained clinical improvement of ischemic symptoms with complete resolution of their ischemic rest pain. Five patients had both pre and postoperative ABI testing. The mean preoperative ABI was 0.42 6 0.22 and 0.41 6 0.08 in the left and right legs, respectively. The mean postoperative ABI was 0.95 6 0.25 and 1.00 6 0.12 in the left and right legs, respectively. The mean improvement of ABIs was 0.50 6 0.15 and 0.59 6 0.15 in the left and right legs, respectively. All patients had a bilateral improvement in the ABI of >0.2, except for one patient where the ABI improved by 0.16 (preoperative 0.67 to postoperative 0.83). Paired twosided t-tests demonstrated statistical significance in the left leg (P ¼ .012) and right leg (P ¼ .002).
DISCUSSION Endovascular treatment of TASC D aortoiliac lesions has expanded rapidly in recent years. Our experience with
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Fig 4. a, The endograft is first deployed (de), then (b) postdeployment dilatation with the (c) Coda balloon (C), which allows full endograft expansion.
Fig 5. a, Proximal aortic stenosis (ps) is still present. b and c, Proximal endograft (pe) extension for the treatment of residual aortic stenosis.
endovascular unibody bifurcated endografts demonstrates excellent technical success, long-term patency, and limited complications. We believe the complication rate will decrease with increased technical experience and improved patient selection. Several papers have reported satisfactory results with endovascular treatment of aortoiliac lesions.12 Krankenberg et al13 reported a series of 11 patients with
complete occlusion of the aortoiliac bifurcation. Endovascular revascularization was achieved with transfemoral balloon angioplasty and selective stent placement in the distal aorta. The iliac arteries were treated with ninitol stents, and postdilated with kissing balloons through a bilateral femoral artery approach. Successful bilateral endovascular stent placement was performed in eight patients (73%) and the remaining three patients underwent
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Fig 6. a and b, Distal extension beyond the left endograft limb (limb) with an iCast (iCast) stent for the treatment of the distal CIA stenosis.
Fig 7. Completion angiography.
successful unilateral stent placement (27%).13 There was one case of acute thrombosis intraoperatively managed by thrombolysis. One patient had unilateral endovascular success and required femorofemoral crossover bypass grafting. At 14 months, there was significant improvement in the ABI and claudication. A similar technique was used in another series of 49 patients with infrarenal aortic occlusion. Again, predilation angioplasty of the aortic lesion was followed by stent placement, and iliac lesions were managed with stents and kissing balloons. Technical success was achieved in 40 patients (81.6%) and there were complications in 8 patients (16.3%). At 1 year, the primary patency rate was 88.4%; at 3 years it was 80.1%. During the study period, five patients required repeat endovascular intervention and two patients required bypass surgery (total of seven patients [17.5%]).14 Sharafuddin et al15 performed a retrospective review of 66 patients who underwent kissing stent reconstruction for aortoiliac occlusive disease (TASC A, B, C, and D lesions). Variables associated with restenosis were radial mismatch (dead space in the aortic lumen around a protruding segment of the stent), female gender, prior occlusion, and residual stenosis.15 Failure of endovascular treatment is a concern, especially if it complicates a secondary open operation. However, Danczyk et al16 demonstrated that failed endovascular therapy for
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Table II. Patient demographic information Characteristics Age, years
Mean 6 SD or No. 59 6 6
Gender, M/F
8/2
Hypertension
10
Hyperlipidemia
7
Smoking history
10
Chronic obstructive pulmonary disease
8
Previous myocardial infarction
1
Congestive heart failure
2
Ejection fraction
50 6 16
Rutherford category 4
6
Rutherford category 5
4
SD, Standard deviation.
aortoiliac occlusive disease will not result in a worse outcome if secondary open surgery is required. Similar to our technique, the use of bifurcated aortic grafts has been reported in a series of 14 patients with TASC C and TASC D aortoiliac lesions. The alternate technique involved a two-step procedure. First, the occlusive lesion was crossed and a 24-hour catheterdirected intra-arterial fibrinolysis was performed with an open-ended perfusion wire (Medtronic Vascular, Danvers, Mass). Next, a balloon angioplasty of the lesions was performed followed by placement of an Excluder endograft (W. L. Gore & Associates). Technical success was achieved in all patients (100%). Two patients (14%) developed unilateral occlusions that were treated with intra-arterial fibrinolysis. At 62 months, the primary patency rate was 85.7%.17 Endografts are used in the treatment of aneurysmal disease; however, their off-label use in the treatment of aortoiliac occlusive disease has only recently been reported.17 The use of covered stents is hypothesized to decrease restenosis by providing a barrier to the ingrowth of neointimal hyperplasia.18 Sabri et al8 compared patency rates between covered and bare metal stents in a retrospective review of 54 patients with aortoiliac occlusive disease. The primary patency rate for covered stents was 92% as compared with 62% for balloon-expandable bare metal stents (follow-up of 29.5 months). Mwipatayi et al10 also demonstrated superior patency rates with covered stents compared with bare metal stents for treatment of aortoiliac occlusive disease. The advantage of covered stents was most evident in patients with TASC D aortoiliac occlusive disease. Our experience supports the endovascular management of TASC D aortoiliac lesions with unibody bifurcated endografts. This unique configuration preserves the aortic bifurcation for subsequent peripheral interventions and is ideal for the treatment of extensive aortic and aortic bifurcation occlusive disease. The covered
nature of these grafts decreases the risk of bleeding if arteries rupture, and provides improved patency compared with bare metal stents.10,19 We initially started using this technique for patients with iliac occlusion and ectatic/aneurysmal aorta. Given our initial technical success, we began using it for only occlusive disease in select patients. We continue to perform the procedure in high-risk patients with occlusive disease involving the aorta in particular. The manufacturer’s Instructions for Use states, “vessels that are significantly calcified, occlusive, tortuous or thrombus-lined may preclude placement of the endovascular graft and/or may increase the risk of embolization.” In off-label use, patient selection is of paramount importance for technical success. The low radial force of the unibody endograft does not preclude its deployment, the graft responds well to postdilation, and if necessary the addition of a balloon-expandable stent such as a Palmaz stent can reinforce inside the endograft for maximal luminal gain in the aorta. However, based on our experience, we believe that patients with very tortuous occluded iliac arteries, and extensive occlusive calcifications of aortoiliac arteries combined with small aortoiliac diameter are not good candidates for this approach. Placement of the device requires that it be advanced into the aorta via a femoral approach, the wire to the contralateral limb is snared, and then the device is pulled down to the aortic bifurcation, with each limb being moved distally in the iliac artery. Bulky occluded aorta with extensive calcification may not respond to a minimum predilation, preventing this maneuver and partial endograft deployment. The graft may become trapped with no “bailout.” Postdilation angiography assesses that minimal luminal gain necessary for endograft positioning and full or partial deployment. Presence of an ectatic or aneurysmal abdominal aorta in TASC D aortoiliac occlusion actually simplifies graft deployment. Occlusion in the iliac arteries not responding to predilation should be stented with balloon-expandable stents to secure a good landing zone for the endograft. Tortuous calcified iliac artery occlusion makes recanalization technically difficult and may also result in endograft iliac limb kinking. Crossing iliac artery occlusions subintimally may be a limiting factor: If the iliac artery does not respond to predilation and/or stenting before endograft deployment, the endograft limb can occlude. This was not a problem in our patients. Another concern with a subintimal plane is iliac rupture, which would be visible on postdilation angiography. Again, we did not encounter this problem but the endograft fabric limits the risk of hemorrhage in case of rupture. We typically used a small diameter (22 mm) endograft. The endograft has an endoskeleton, and infolding is not a major concern. Despite its poor radial force, the endograft adapts well to even a small diameter aorta after balloon angioplasty.
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The endograft is costly and should be used selectively. In many cases a kissing stent technique is significantly more cost effective. Based on our experience, we favor now the use of unibody bifurcated endografts when (1) preservation of the aortic bifurcation is important, for example, in patients with infrainguinal occlusive disease who may need future extremity revascularization, and/or (2) in TASC D lesions with significant aortic involvement (occlusive or aneurysmal). The endgraft allows full coverage of the stenotic/occlusive aorta with maximum luminal gain. Endologix manufactures now an endograft with a short main body trunk of 40 mm with a 22-mm diameter, very helpful in aortic bifurcation and distal aortic occlusions. Optimizing the iliofemoral outflow is a key component of long-term success and every effort should be made to avoid and/or identify potential iliac or femoral artery stenosis during intervention and follow-up and prevent iliac limb thrombosis. Patients should be warned of early symptoms of recurrent claudication and appropriate noninvasive imaging should be obtained. There are several limitations to our study. It is a single institution retrospective review, and included a small sample size owing to the novelty of the technique.
3. 4.
5.
6.
7.
8.
9.
10.
CONCLUSIONS This paper demonstrates that unibody bifurcated endografts used in the treatment of TASC D aortoiliac occlusive disease are safe, effective, and in our opinion most beneficial when aortic involvement is present. The unibody configuration preserves the anatomic aortic bifurcation, which is particularly important in patients with peripheral occlusive disease who are deemed to undergo subsequent endovascular interventions. The technical success has been good and midterm patency rates promising. We believe that procedural complications can gradually be reduced with adequate preoperative planning, increased experience with the technique, and improved patient selection.
11.
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14.
15.
AUTHOR CONTRIBUTIONS Conception and design: RV, LG, OV, JK, AB Analysis and interpretation: RV, LG, AB Data collection: RV, LG, OV, JK, AB Writing the article: RV, LG, AB Critical revision of the article: LG, AB Final approval of the article: RV, LG, OV, JK, AB Statistical analysis: RV Obtained funding: Not applicable Overall responsibility: AB
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Submitted Apr 21, 2016; accepted Aug 3, 2016.