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Using bifurcated endoprosthesis after iliac artery recanalization for concomitant abdominal aortic aneurysm and chronic total occlusions of access routes
Using bifurcated endoprosthesis after iliac artery recanalization for concomitant abdominal aortic aneurysm and chronic total occlusions of access routes Yuriko Takeuchi, MD, PhD, Noriyasu Morikage, MD, PhD, Takahiro Mizoguchi, MD, Takashi Nagase, MD, Makoto Samura, MD, PhD, Koshiro Ueda, MD, PhD, Kotaro Suehiro, MD, PhD, and Kimikazu Hamano, MD, PhD, Yamaguchi, Japan
ABSTRACT Objective: Concurrent abdominal aortic aneurysm (AAA) and unilateral iliac occlusion is a challenge in the implantation of bifurcated stent grafts (BFGs). The endovascular approach is less invasive than open surgery; the aortouni-iliac (AUI) graft with crossover femorofemoral bypass (CFFB) has many problems associated with extra-anatomic reconstruction. We attempted endovascular aneurysm repair (EVAR) using BFGs in such cases and evaluated the outcomes. Methods: This was a retrospective study. Between October 2012 and December 2017, there were 649 patients who underwent surgery for AAA, of whom 32 patients underwent open reconstruction and 617 patients underwent endovascular aneurysm repair; 15 patients with unilateral occluded iliac arteries and AAA were included. The analysis included patients with unilateral iliac chronic total occlusion (CTO). The intraoperative, postoperative, and follow-up variables were reviewed. Results: The occluded lesions were the common iliac artery in 5 patients, the common iliac artery-external iliac artery (EIA) in 2 patients, the EIA in 7 patients, and the EIA-common femoral artery in 1 patient. The mean occlusive length was 89.7 6 43.6 mm, and the mean AAA size was 54.6 6 5.6 mm. Technical success was achieved in 13 patients (87%). All patients underwent recanalization through the true lumen and stent placement. The only procedure-related complication was distal embolism, which was treated with intraoperative thrombectomy. Recanalization of CTO lesions was not possible in two patients (13%), who underwent AUI graft placement with CFFB. The 30-day mortality and morbidity rates were 0%. The mean follow-up periods were 12 and 32 months for patients who underwent BFG placement and AUI graft placement with CFFB, respectively. During follow-up, the primary patency rate of successfully recanalized arteries was 100%. Aneurysm size decreased in four patients who underwent BFG placement; no change was seen in the other 11 patients. Freedom from aneurysm-related events was 100%; no patient needed secondary interventions. All patients with claudication pain preoperatively reported improvement in their symptoms during follow-up. In addition, the anklebrachial index improved significantly from 0.51 6 0.25 preoperatively to 0.88 6 0.20 postoperatively (P < .001) in patients who underwent BFG placement. Conclusions: Recanalization of unilateral iliac CTO lesions and placement of BFG in cases with concomitant aneurysmal disease and unilateral iliac occlusive disease demonstrated a significant primary patency rate with improvements in claudication and ankle-brachial index. (J Vasc Surg 2018;-:1-6.) Keywords: EVAR; CTO; bifurcated stent graft; Aortouni-iliac device; Crossover femorofemoral bypass
Endovascular aneurysm repair (EVAR) is gaining popularity in the management of abdominal aortic aneurysms (AAAs).1,2 However, the anatomy in some patients is not ideal for EVAR, and up to 6% to 15.4% of patients may undergo open aneurysm repair because of inadequate size of the access vessel for delivery of a stent graft.3,4
From the Division of Vascular Surgery, Department of Surgery and Clinical Science, Yamaguchi University Graduate School of Medicine. Author conflict of interest: none. Correspondence: Noriyasu Morikage, MD, PhD, Division of Vascular Surgery, Department of Surgery and Clinical Science, Yamaguchi University Graduate School of Medicine, Minami-kogushi 1-1-1, Ube, Yamaguchi 755-8505, Japan (e-mail: [email protected]). 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 Copyright Ó 2018 by the Society for Vascular Surgery. Published by Elsevier Inc. https://doi.org/10.1016/j.jvs.2018.08.191
Simultaneous occurrence of AAA and iliac occlusion is rare and remains a challenge in endograft implantations. As the complications of combined aneurysmal disease and iliac total occlusion are outside the instructions for use, open surgical repair has been the first choice in these cases. However, the endovascular approach is less invasive than open surgery and has improved progressively. Therefore, the aortouni-iliac (AUI) stent graft with adjunctive crossover femorofemoral bypass (CFFB) was developed to overcome the problems of uncommon iliac anatomy. However, this approach has been shown to have unsatisfactory primary and secondary stent graft patency rates in patients with iliac artery occlusive disease,5 and there are some cases in which hypogastric perfusion needs to be sacrificed. Furthermore, femoral grafts pose a higher risk of infection, occlusion, and hemodynamically significant steal of blood flow in the donor leg.6 On the other hand, there are some reports on the use of bifurcated stent graft (BFG) with favorable 1
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outcomes in patients with aortoiliac occlusive disease, such as TransAtlantic Inter-Society Consensus (TASC) classification C and D lesions without aneurysmal disease.7,8 However, little is known about the outcomes of the use of BFGs in patients with concomitant aneurysmal disease and aortoiliac occlusive disease, especially chronic total occlusion (CTO).9 Herein, we report the outcomes of BFG placement in these patients as the standard management.
ARTICLE HIGHLIGHTS d
d
d
METHODS We retrospectively analyzed the data of patients who underwent attempted iliac recanalization of chronic unilateral iliac occlusions and concurrent EVAR of infrarenal AAA at the Yamaguchi University Hospital (Yamaguchi, Japan) between October 2012 and December 2017. All the patients with unilateral iliac occlusion as well as AAA in whom EVAR with BFG placement was attempted were included. The analyses excluded the patients with acute iliac thrombosis and those with severely stenotic (but patent) iliac vessels. For this research, informed consent of each recruited patient was mandatory. Indications for EVAR included patients with infrarenal AAA of $5.0 cm, saccular type of aneurysm, and common iliac artery (CIA) aneurysm of $3.0 cm with favorable endovascular anatomy. On preoperative computed tomography angiography (CTA), diffuse calcification was defined as diffuse high densities along the CTO vessels; focal dissection was identified as intraluminal calcified lesions that were considered to be the endothelium dissociated from the vessel wall. As we attempted to place BFGs in these patients, we initially tried to cross the CTO lesions. To start with, the CTO lesions were approached in a retrograde fashion from the same side as the CTO vessels with a 0.035inch Radifocus M guidewire (Terumo Europe, Leuven, Belgium) or a 0.018-inch Treasure 12 guidewire (Asahi Intec, Nagoya, Japan). If crossing of the lesions was difficult with the ipsilateral approach, the contralateral antegrade approach through the aortic bifurcation was attempted, followed by the pull-through approach, depending on the situation. After wire crossing through the CTO lesions, we confirmed the patency of the true lumen by angiography. Then, EVAR was performed by bilateral groin access, with initial angiography for localization of the renal and hypogastric arteries and definitive sizing of the graft length. The main body was inserted from the contralateral side of the recanalized vessel, and the contralateral leg was inserted from the ipsilateral side of the recanalized vessel through the 12F DrySeal sheath (W. L. Gore & Associates, Flagstaff, Ariz). A final angiogram was obtained to evaluate possible endoleaks and residual stenotic lesions. All type I and type III endoleaks were addressed intraoperatively, whereas type II endoleaks were only observed. Technical success was defined as the completion of EVAR with BFG without
2018
Type of Research: Retrospective cohort study Take Home Message: Endovascular treatment of abdominal aortic aneurysm with recanalization of an occluded iliac artery was technically successful in 13 of 15 patients (87%) and associated with a 100% patency and freedom from aneurysm-related events at a mean of 12 months. Recommendation: This study suggests that recanalization of an occluded iliac artery at the time of endovascular aneurysm repair is technically possible and effective.
residual type I or type III endoleaks as evaluated by completion angiography. In cases with failure of the wire crossing for the CTO lesion, AUI graft placement with adjunctive CFFB was performed. Clinical follow-up examination including palpable common femoral artery (CFA) pulses, presence or absence of claudication, and ankle-brachial index (ABI) was performed at discharge and at 3, 6, 9, and 12 months after operation, followed by every 6 months thereafter. On follow-up, CTA was performed at discharge; at 3, 6, and 12 months; and every 6 months thereafter, depending on renal function. Endoleaks were evaluated by final CTA at the final follow-up point, and shrinkage of aneurysms was defined as a decrease in size by $5 mm. Institutional Review Board approval was not obtained for this study because there is no need to obtain it in our institution. Instead, all study participants provided informed consent. Statistical analyses were performed with Stata/SE 12.1 software (StataCorp LP, College Station, Tex). Data are expressed as mean 6 standard deviation. Continuous variables were compared between two groups using Student t-test. A P value <.05 was considered significant.
RESULTS Between October 2012 and December 2017, a total of 649 patients underwent surgery for AAA; among these, 32 underwent open reconstruction, and we performed EVAR in 617 patients. Of these, we identified 15 patients with 15 occluded iliac arteries and AAAs. The characteristics of the patients and lesions are presented in Table I and Fig 1. The average age of the patients was 76.9 years, and 87% of the patients were men. The primary indication for intervention was almost always the size and shape of the aneurysm, except for disabling claudication in one patient. All patients included in this study had AAAs including small aneurysms, except one patient who had CIA aneurysm. All patients had unilateral iliac occlusions; seven patients (47%) presented with external iliac artery (EIA) occlusions, five (33%) with CIA occlusions, two (13%) with combined CIA and EIA occlusions, and
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Table I. Characteristics of the patients (N ¼ 15) 76.9 6 7.9
Age, years Male
13 (87)
Indication for operation Size of AAA
8 (53)
Size of CIA aneurysm
4 (27)
Saccular AAA
2 (13)
Claudication
1 (7)
Aneurysm size, mm AAAa
54.6 6 5.6
CIA aneurysm
35.4 6 3.6
Intermittent claudication
8 (53) 89.7 6 43.6
Occlusion length, mm Status of CTO lesion Diffuse calcificationb
2 (13)
Focal dissectionc
3 (20)
AAA, Abdominal aortic aneurysm; CIA, common iliac artery; CTO, chronic total occlusion. Categorical variables are presented as number (%). Continuous variables are presented as mean 6 standard deviation. a Except saccular AAA. b Diffuse calcification is defined as diffuse high densities along the CTO vessels on preoperative computed tomography angiography. c Focal dissection is defined as intraluminal calcified lesions considered to be the endothelium that dissociated from the vessel wall on preoperative computed tomography angiography.
CIA
5 (33)
3
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CIA-EIA
2 (13)
EIA
7 (47)
EIA-CFA
1 (7)
Fig 1. Occluded vessel classification in all the included patients. Data are given as number (%). CFA, Common femoral artery; CIA, common iliac artery; EIA, external iliac artery.
one (7%) with combined EIA and CFA occlusion. The average length of the occluded iliac segment was 89.7 mm. The status of the CTO lesion as evaluated by preoperative CTA included diffuse calcification in two patients (13%) and focal dissection in three patients (20%). Technical success was achieved in 13 of 15 patients (87%). All patients had recanalization through the true lumen, and no re-entry devices were used. All cases underwent placement of a bare-metal stent (BMS) or a stent graft leg for the recanalized lesions, and we chose a BMS for dilation of the recanalized EIA in principle. In cases with concomitant CIA aneurysms, embolization of the internal iliac artery (IIA) by plug or coil was performed with EIA landing of the stent graft. In the four cases (31%) in which the occluded EIAs were recanalized and the CIA aneurysms were absent, the CIA was chosen as the distal landing zone of the stent graft for the
preservation of IIA perfusion and an additional BMS was placed for the recanalized EIA. However, covered stents were extended to the EIA with embolization for the IIA, even though the CIA aneurysm was absent in only one case that was suspected of injury to recanalized lesions. The devices that dilated the recanalized lesions are shown in Table II. A total of six patients (46%) underwent the placement of a BMS for recanalized lesions. The BMSs that were used were all self-expandable stents, except for one balloon-expandable stent. In the patient with unilateral EIA-CFA occlusion, we performed stent graft placement to the distal EIA combined with endarterectomy and patch plasty with vein graft for a CFA occlusive lesion. Other intraoperative variables are shown in Table II. Although the insertion of the 12F sheath into the recanalized vessels was not difficult in most cases, there were two cases that required predilation by a balloon for the recanalized lesions before the insertion of the 12F sheaths. Of these cases, distal embolism from the recanalized vessel to the superficial femoral artery occurred in one (Table II). This was resolved by intraoperative thrombectomy. In another case, because it was difficult to insert the 12F sheath through the recanalized lesion, we performed predilation, resulting in no complications. Recanalization of CTO lesions could not be performed in two patients (13%), and they underwent AUI graft placement with CFFB. Both cases received the Endurant (Medtronic, Santa Rosa, Calif) devices as the AUI stent graft, and their distal landing zones were CIA and EIA, respectively. Femorofemoral bypasses were performed using 7- to 8-mm-diameter expanded polytetrafluoroethylene bypass grafts. Of them, one patient had patent CIA and IIA on the side of the occluded EIA, and both CIA and IIA were embolized by plugs to prevent type II endoleaks from these vessels. The average surgical time for these patients was 274 6 35 minutes. There were no intraoperative endoleaks or complications. The mean follow-up period was 12 months in the patients who underwent BFG placement and 32 months in the patients who underwent AUI graft placement with CFFB. During these follow-up periods, there was 100% primary patency of successfully recanalized arteries and stent graft limbs. The aneurysm size decreased in four patients who underwent BFG; no change was seen in the other 11 patients. Type II endoleak from the lumbar artery was observed in one patient who underwent AUI stent graft placement with CFFB (Table III). Freedom from aneurysm-related events was 100%; no patients needed secondary intervention for endoleak or limb occlusion. All patients who complained of claudication preoperatively reported improvements in their symptoms at follow-up. Furthermore, ABI improved significantly from 0.51 6 0.25 preoperatively to 0.88 6 0.20 postoperatively (P < .001; Fig 2). The improvements in ABI were maintained during the follow-up period in all
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P < .001
Table II. Intraoperative variables for endovascular aneurysm repair (EVAR) with bifurcated stent graft (BFG; N ¼ 13) 228 6 64
Operative time, minutes
2018
1.2
0.51 0.25
0.88 0.20
Approach to the CTO lesiona Ipsilateral
9 (69)
Contralateral
4 (31)
1 0.8
Device of the main body Endurant
7 (54)
Excluder
6 (46)
0.6
13 (100)
0.4
CIA
5 (38)
0.2
EIA
8 (62)
Device of the contralateral leg Excluder Landing zone of the contralateral leg
0
Device placed for recanalized CTO lesions Covered stent
7 (54)
Covered stent þ lining BMS
2 (15)
BMS
4 (31)
Additional procedures Embolization of IIA
5 (38)
Embolization of IMA
1 (8)
Endarterectomy of CFA
1 (8)
Endowedge of renal artery
1 (8)
Proximal extension
1 (8)
Type I or type III endoleak
0 (0)
Complications Acute arterial occlusion
1 (8)
BMS, Bare-metal stent; CFA, common femoral artery; CIA, common iliac artery; CTO, chronic total occlusion; EIA, external iliac artery; IIA, internal iliac artery; IMA, inferior mesenteric artery. Categorical variables are presented as number (%). Continuous variables are presented as mean 6 standard deviation. a The side used for successful wire crossing of the CTO lesion. Ipsilateral indicates the side of the CTO vessel.
Table III. Postoperative outcomes BFG (n ¼ 13)
AUI stent graft þ CFFB (n ¼ 2)
Follow-up period, months
12 6 17
32 6 19
Patency
13 (100)
2 (100)
Reintervention
0 (0)
0 (0)
Postoperative endoleak
0 (0)
Shrinkage of aneurysmal sac
4 (31)
1 (50)a 0 (0)
AUI, Aortouni-iliac; BFG, bifurcated stent graft; CFFB, crossover femorofemoral bypass. Categorical variables are presented as number (%). Continuous variables are presented as mean 6 standard deviation. a Postoperative type II endoleak from the lumbar artery without aneurysmal enlargement was observed in one patient who underwent AUI stent graft placement with CFFB.
the cases. There were no amputations or deaths within 30 days of the procedures in these patients. One patient died during follow-up after 59 months of acute type A aortic dissection, and another patient died of malignant disease after 33 months.
Preop
3-month
Fig 2. Fluctuation of the mean ankle-brachial index (ABI) in patients who underwent bifurcated stent graft (BFG) placement, measured preoperatively and at 3 months postoperatively. The data were compared between the preoperative measurements and at 3 months postoperatively by Student t-test. Data are given as mean 6 standard deviation.
DISCUSSION Recanalization of the occluded iliac arteries and BFG placement have the advantages of preservation of hypogastric artery perfusion10,11 and lack of risk of femoral graft infection and occlusion12; in addition, there is only a small risk of hemodynamically significant steal of blood flow in the donor leg in these procedures.6 One of the potential complications is endograft limb occlusion in cases in which the recanalized lesions remain stenotic even if the lesions are dilated by stent graft limb or BMS. Several anatomic risk factors, such as calcification, angulation, presence of thrombus, and narrow diameter, and procedure-related risk factors, such as endograft oversizing and extension to the EIA, are predictors of limb occlusion.13-16 In this study, although there were extensions into the EIA in 8 of 13 patients (62%), limb occlusion was not seen in any of them. Treatment with a covered stent was reported to show no significant improvements in the primary patency rates compared with BMS for aortoiliac occlusive disease.17 Therefore, we did not extend the stent graft limb into the EIA to prevent limb occlusion and generally dilated the recanalized EIA by BMS as long as there was no CIA aneurysm and no possibility of rupture of the EIA. We used Excluder (W. L. Gore & Associates) legs for all EIAs because they are known to prevent kinks and to reduce limb occlusion.18 We believe these strategies led to the favorable outcomes of 100% patency and ABI restoration. The aneurysmal outcomes were also satisfactory with permissible occurrence of endoleaks and shrinkage of the sacs. We believe that the recanalization of CTO
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lesions in the access route with subsequent BFG placement is durable and effective enough to treat the concomitant aneurysmal disease and iliac CTO lesions as was reported by another study.9 Our technical success rate was 87%, and 2 of 15 patients (13%) had technical failure due to disabling of wire crossing of the CTO lesions. These patients had several features that might have contributed to the failure. One patient had occlusion with localized dissection as observed on preoperative CTA. We recognized calcification within the thrombotic occlusive vessel, not around the vessel, as the calcified endothelium that was separated from the vessel walldin other words, occlusion based on the localized dissection. The other patient had severe tortuosity and excessive diffuse calcification along the occlusive vessel. In these cases, we believe that the guidewire may have strayed into the subintimal layer. It is difficult to determine whether these features were the risk factors for the technical failure because recanalization was achieved in some cases even with these features. Therefore, we cannot abandon the endovascular approach on the basis of the findings of preoperative CTA. The field of endovascular surgery is rapidly progressing, and recent improvements in the devices and the increased experience of the interventionists have enabled the use of endovascular therapy for extensive iliac artery occlusive disease.19-21 There is the possibility of complications, such as artery rupture and distal embolism, during the procedure of recanalization.22,23 Although we did not experience obvious iliac artery rupture in this study, we were prepared for this possibility, for which an occlusion balloon is inserted from the contralateral side to occlude the vessel proximal to the rupture site in high-risk cases of rupture. Moreover, distal embolism occurred in one case in our study. We performed predilation for the recanalized CTO lesions before the insertion of 12F sheaths in two cases, and of them, one developed distal embolism in the superficial femoral artery. Although this maneuver is sometimes inevitably required for the insertion of large sheaths, it is better not to perform predilation for the plaque-rich CTO lesion before insertion of the large sheath if possible. Furthermore, recanalization of CTO in the CIA also has the risk of distal thrombus embolization to the IIA, which can cause buttock necrosis; however, we did not encounter it in this study. To prevent this complication, embolic protection filter devices are being developed but are not yet in general use. Further research is required to overcome the problem of distal embolism. Our study has some limitations. The number of patients was small, and there was a short follow-up period. Further investigations are warranted to corroborate our findings. Nevertheless, there are no reports larger than ours in terms of the sample size and short-term outcomes. Furthermore, it is relatively easy to perform additional procedures if the necessity arises for secondary interventions in the future.
CONCLUSIONS Recanalization of iliac CTO lesions and placement of a BFG in cases with concomitant aneurysmal disease and unilateral iliac occlusive disease demonstrated significant primary patency rate along with restoration of claudication and ABI. Therefore, this is a promising treatment option in these patients.
AUTHOR CONTRIBUTIONS Conception and design: NM, KS, KH Analysis and interpretation: YT, NM Data collection: YT, TM, TN, MS, KU Writing the article: YT Critical revision of the article: NM, TM, TN, MS, KU, KS, KH Final approval of the article: YT, NM, TM, TN, MS, KU, KS, KH Statistical analysis: YT Obtained funding: Not applicable Overall responsibility: KH
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12. Donor limb vascular events following femoro-femoral bypass surgery. A Veterans Affairs Cooperative Study. Arch Surg 1991;126:681-5. 13. Taudorf M, Jensen LP, Vogt KC, Gronvall J, Schroeder TV, Lonn L. Endograft limb occlusion in EVAR: iliac tortuosity quantified by three different indices on the basis of preoperative CTA. Eur J Vasc Endovasc Surg 2014;48:527-33. 14. Mantas GK, Antonopoulos CN, Sfyroeras GS, Moulakakis KG, Kakisis JD, Mylonas SN, et al. Factors predisposing to endograft limb occlusion after endovascular aortic repair. Eur J Vasc Endovasc Surg 2015;49:39-44. 15. Cochennec F, Becquemin JP, Desgranges P, Allaire E, Kobeiter H, Roudot-Thoraval F. Limb graft occlusion following EVAR: clinical pattern, outcomes and predictive factors of occurrence. Eur J Vasc Endovasc Surg 2007;34: 59-65. 16. Carroccio A, Faries PL, Morrissey NJ, Teodorescu V, Burks JA, Gravereaux EC, et al. Predicting iliac limb occlusions after bifurcated aortic stent grafting: anatomic and devicerelated causes. J Vasc Surg 2002;36:679-84. 17. Hajibandeh S, Hajibandeh S, Antoniou SA, Torella F, Antoniou GA. Covered vs uncovered stents for aortoiliac and femoropopliteal arterial disease: a systematic review and meta-analysis. J Endovasc Ther 2016;23:442-52.
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18. Bos WT, Tielliu IF, Sondakh AO, Vourliotakis G, Bracale UM, Verhoeven EL. Hybrid endograft solution for complex iliac anatomy: Zenith body and Excluder limbs. Vascular 2010;18: 136-40. 19. Soga Y, Iida O, Kawasaki D, Yamauchi Y, Suzuki K, Hirano K, et al. Contemporary outcomes after endovascular treatment for aorto-iliac artery disease. Circ J 2012;76:2697-704. 20. Leville CD, Kashyap VS, Clair DG, Bena JF, Lyden SP, Greenberg RK, et al. Endovascular management of iliac artery occlusions: extending treatment to TransAtlantic Inter-Society Consensus class C and D patients. J Vasc Surg 2006;43:32-9. 21. 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. 22. Allaire E, Melliere D, Poussier B, Kobeiter H, Desgranges P, Becquemin JP. Iliac artery rupture during balloon dilatation: what treatment? Ann Vasc Surg 2003;17:306-14. 23. Leu AJ, Schneider E, Canova CR, Hoffmann U. Long-term results after recanalisation of chronic iliac artery occlusions by combined catheter therapy without stent placement. Eur J Vasc Endovasc Surg 1999;18:499-505.
Submitted Mar 20, 2018; accepted Aug 29, 2018.
ABSTRACT Objective: Concurrent abdominal aortic aneurysm (AAA) and unilateral iliac occlusion is a challenge in the implantation of bifurcated stent grafts (BFGs). The endovascular approach is less invasive than open surgery; the aortouni-iliac (AUI) graft with crossover femorofemoral bypass (CFFB) has many problems associated with extra-anatomic reconstruction. We attempted endovascular aneurysm repair (EVAR) using BFGs in such cases and evaluated the outcomes. Methods: This was a retrospective study. Between October 2012 and December 2017, there were 649 patients who underwent surgery for AAA, of whom 32 patients underwent open reconstruction and 617 patients underwent endovascular aneurysm repair; 15 patients with unilateral occluded iliac arteries and AAA were included. The analysis included patients with unilateral iliac chronic total occlusion (CTO). The intraoperative, postoperative, and follow-up variables were reviewed. Results: The occluded lesions were the common iliac artery in 5 patients, the common iliac artery-external iliac artery (EIA) in 2 patients, the EIA in 7 patients, and the EIA-common femoral artery in 1 patient. The mean occlusive length was 89.7 6 43.6 mm, and the mean AAA size was 54.6 6 5.6 mm. Technical success was achieved in 13 patients (87%). All patients underwent recanalization through the true lumen and stent placement. The only procedure-related complication was distal embolism, which was treated with intraoperative thrombectomy. Recanalization of CTO lesions was not possible in two patients (13%), who underwent AUI graft placement with CFFB. The 30-day mortality and morbidity rates were 0%. The mean follow-up periods were 12 and 32 months for patients who underwent BFG placement and AUI graft placement with CFFB, respectively. During follow-up, the primary patency rate of successfully recanalized arteries was 100%. Aneurysm size decreased in four patients who underwent BFG placement; no change was seen in the other 11 patients. Freedom from aneurysm-related events was 100%; no patient needed secondary interventions. All patients with claudication pain preoperatively reported improvement in their symptoms during follow-up. In addition, the anklebrachial index improved significantly from 0.51 6 0.25 preoperatively to 0.88 6 0.20 postoperatively (P < .001) in patients who underwent BFG placement. Conclusions: Recanalization of unilateral iliac CTO lesions and placement of BFG in cases with concomitant aneurysmal disease and unilateral iliac occlusive disease demonstrated a significant primary patency rate with improvements in claudication and ankle-brachial index. (J Vasc Surg 2018;-:1-6.) Keywords: EVAR; CTO; bifurcated stent graft; Aortouni-iliac device; Crossover femorofemoral bypass
Endovascular aneurysm repair (EVAR) is gaining popularity in the management of abdominal aortic aneurysms (AAAs).1,2 However, the anatomy in some patients is not ideal for EVAR, and up to 6% to 15.4% of patients may undergo open aneurysm repair because of inadequate size of the access vessel for delivery of a stent graft.3,4
From the Division of Vascular Surgery, Department of Surgery and Clinical Science, Yamaguchi University Graduate School of Medicine. Author conflict of interest: none. Correspondence: Noriyasu Morikage, MD, PhD, Division of Vascular Surgery, Department of Surgery and Clinical Science, Yamaguchi University Graduate School of Medicine, Minami-kogushi 1-1-1, Ube, Yamaguchi 755-8505, Japan (e-mail: [email protected]). 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 Copyright Ó 2018 by the Society for Vascular Surgery. Published by Elsevier Inc. https://doi.org/10.1016/j.jvs.2018.08.191
Simultaneous occurrence of AAA and iliac occlusion is rare and remains a challenge in endograft implantations. As the complications of combined aneurysmal disease and iliac total occlusion are outside the instructions for use, open surgical repair has been the first choice in these cases. However, the endovascular approach is less invasive than open surgery and has improved progressively. Therefore, the aortouni-iliac (AUI) stent graft with adjunctive crossover femorofemoral bypass (CFFB) was developed to overcome the problems of uncommon iliac anatomy. However, this approach has been shown to have unsatisfactory primary and secondary stent graft patency rates in patients with iliac artery occlusive disease,5 and there are some cases in which hypogastric perfusion needs to be sacrificed. Furthermore, femoral grafts pose a higher risk of infection, occlusion, and hemodynamically significant steal of blood flow in the donor leg.6 On the other hand, there are some reports on the use of bifurcated stent graft (BFG) with favorable 1
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outcomes in patients with aortoiliac occlusive disease, such as TransAtlantic Inter-Society Consensus (TASC) classification C and D lesions without aneurysmal disease.7,8 However, little is known about the outcomes of the use of BFGs in patients with concomitant aneurysmal disease and aortoiliac occlusive disease, especially chronic total occlusion (CTO).9 Herein, we report the outcomes of BFG placement in these patients as the standard management.
ARTICLE HIGHLIGHTS d
d
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METHODS We retrospectively analyzed the data of patients who underwent attempted iliac recanalization of chronic unilateral iliac occlusions and concurrent EVAR of infrarenal AAA at the Yamaguchi University Hospital (Yamaguchi, Japan) between October 2012 and December 2017. All the patients with unilateral iliac occlusion as well as AAA in whom EVAR with BFG placement was attempted were included. The analyses excluded the patients with acute iliac thrombosis and those with severely stenotic (but patent) iliac vessels. For this research, informed consent of each recruited patient was mandatory. Indications for EVAR included patients with infrarenal AAA of $5.0 cm, saccular type of aneurysm, and common iliac artery (CIA) aneurysm of $3.0 cm with favorable endovascular anatomy. On preoperative computed tomography angiography (CTA), diffuse calcification was defined as diffuse high densities along the CTO vessels; focal dissection was identified as intraluminal calcified lesions that were considered to be the endothelium dissociated from the vessel wall. As we attempted to place BFGs in these patients, we initially tried to cross the CTO lesions. To start with, the CTO lesions were approached in a retrograde fashion from the same side as the CTO vessels with a 0.035inch Radifocus M guidewire (Terumo Europe, Leuven, Belgium) or a 0.018-inch Treasure 12 guidewire (Asahi Intec, Nagoya, Japan). If crossing of the lesions was difficult with the ipsilateral approach, the contralateral antegrade approach through the aortic bifurcation was attempted, followed by the pull-through approach, depending on the situation. After wire crossing through the CTO lesions, we confirmed the patency of the true lumen by angiography. Then, EVAR was performed by bilateral groin access, with initial angiography for localization of the renal and hypogastric arteries and definitive sizing of the graft length. The main body was inserted from the contralateral side of the recanalized vessel, and the contralateral leg was inserted from the ipsilateral side of the recanalized vessel through the 12F DrySeal sheath (W. L. Gore & Associates, Flagstaff, Ariz). A final angiogram was obtained to evaluate possible endoleaks and residual stenotic lesions. All type I and type III endoleaks were addressed intraoperatively, whereas type II endoleaks were only observed. Technical success was defined as the completion of EVAR with BFG without
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Type of Research: Retrospective cohort study Take Home Message: Endovascular treatment of abdominal aortic aneurysm with recanalization of an occluded iliac artery was technically successful in 13 of 15 patients (87%) and associated with a 100% patency and freedom from aneurysm-related events at a mean of 12 months. Recommendation: This study suggests that recanalization of an occluded iliac artery at the time of endovascular aneurysm repair is technically possible and effective.
residual type I or type III endoleaks as evaluated by completion angiography. In cases with failure of the wire crossing for the CTO lesion, AUI graft placement with adjunctive CFFB was performed. Clinical follow-up examination including palpable common femoral artery (CFA) pulses, presence or absence of claudication, and ankle-brachial index (ABI) was performed at discharge and at 3, 6, 9, and 12 months after operation, followed by every 6 months thereafter. On follow-up, CTA was performed at discharge; at 3, 6, and 12 months; and every 6 months thereafter, depending on renal function. Endoleaks were evaluated by final CTA at the final follow-up point, and shrinkage of aneurysms was defined as a decrease in size by $5 mm. Institutional Review Board approval was not obtained for this study because there is no need to obtain it in our institution. Instead, all study participants provided informed consent. Statistical analyses were performed with Stata/SE 12.1 software (StataCorp LP, College Station, Tex). Data are expressed as mean 6 standard deviation. Continuous variables were compared between two groups using Student t-test. A P value <.05 was considered significant.
RESULTS Between October 2012 and December 2017, a total of 649 patients underwent surgery for AAA; among these, 32 underwent open reconstruction, and we performed EVAR in 617 patients. Of these, we identified 15 patients with 15 occluded iliac arteries and AAAs. The characteristics of the patients and lesions are presented in Table I and Fig 1. The average age of the patients was 76.9 years, and 87% of the patients were men. The primary indication for intervention was almost always the size and shape of the aneurysm, except for disabling claudication in one patient. All patients included in this study had AAAs including small aneurysms, except one patient who had CIA aneurysm. All patients had unilateral iliac occlusions; seven patients (47%) presented with external iliac artery (EIA) occlusions, five (33%) with CIA occlusions, two (13%) with combined CIA and EIA occlusions, and
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Table I. Characteristics of the patients (N ¼ 15) 76.9 6 7.9
Age, years Male
13 (87)
Indication for operation Size of AAA
8 (53)
Size of CIA aneurysm
4 (27)
Saccular AAA
2 (13)
Claudication
1 (7)
Aneurysm size, mm AAAa
54.6 6 5.6
CIA aneurysm
35.4 6 3.6
Intermittent claudication
8 (53) 89.7 6 43.6
Occlusion length, mm Status of CTO lesion Diffuse calcificationb
2 (13)
Focal dissectionc
3 (20)
AAA, Abdominal aortic aneurysm; CIA, common iliac artery; CTO, chronic total occlusion. Categorical variables are presented as number (%). Continuous variables are presented as mean 6 standard deviation. a Except saccular AAA. b Diffuse calcification is defined as diffuse high densities along the CTO vessels on preoperative computed tomography angiography. c Focal dissection is defined as intraluminal calcified lesions considered to be the endothelium that dissociated from the vessel wall on preoperative computed tomography angiography.
CIA
5 (33)
3
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CIA-EIA
2 (13)
EIA
7 (47)
EIA-CFA
1 (7)
Fig 1. Occluded vessel classification in all the included patients. Data are given as number (%). CFA, Common femoral artery; CIA, common iliac artery; EIA, external iliac artery.
one (7%) with combined EIA and CFA occlusion. The average length of the occluded iliac segment was 89.7 mm. The status of the CTO lesion as evaluated by preoperative CTA included diffuse calcification in two patients (13%) and focal dissection in three patients (20%). Technical success was achieved in 13 of 15 patients (87%). All patients had recanalization through the true lumen, and no re-entry devices were used. All cases underwent placement of a bare-metal stent (BMS) or a stent graft leg for the recanalized lesions, and we chose a BMS for dilation of the recanalized EIA in principle. In cases with concomitant CIA aneurysms, embolization of the internal iliac artery (IIA) by plug or coil was performed with EIA landing of the stent graft. In the four cases (31%) in which the occluded EIAs were recanalized and the CIA aneurysms were absent, the CIA was chosen as the distal landing zone of the stent graft for the
preservation of IIA perfusion and an additional BMS was placed for the recanalized EIA. However, covered stents were extended to the EIA with embolization for the IIA, even though the CIA aneurysm was absent in only one case that was suspected of injury to recanalized lesions. The devices that dilated the recanalized lesions are shown in Table II. A total of six patients (46%) underwent the placement of a BMS for recanalized lesions. The BMSs that were used were all self-expandable stents, except for one balloon-expandable stent. In the patient with unilateral EIA-CFA occlusion, we performed stent graft placement to the distal EIA combined with endarterectomy and patch plasty with vein graft for a CFA occlusive lesion. Other intraoperative variables are shown in Table II. Although the insertion of the 12F sheath into the recanalized vessels was not difficult in most cases, there were two cases that required predilation by a balloon for the recanalized lesions before the insertion of the 12F sheaths. Of these cases, distal embolism from the recanalized vessel to the superficial femoral artery occurred in one (Table II). This was resolved by intraoperative thrombectomy. In another case, because it was difficult to insert the 12F sheath through the recanalized lesion, we performed predilation, resulting in no complications. Recanalization of CTO lesions could not be performed in two patients (13%), and they underwent AUI graft placement with CFFB. Both cases received the Endurant (Medtronic, Santa Rosa, Calif) devices as the AUI stent graft, and their distal landing zones were CIA and EIA, respectively. Femorofemoral bypasses were performed using 7- to 8-mm-diameter expanded polytetrafluoroethylene bypass grafts. Of them, one patient had patent CIA and IIA on the side of the occluded EIA, and both CIA and IIA were embolized by plugs to prevent type II endoleaks from these vessels. The average surgical time for these patients was 274 6 35 minutes. There were no intraoperative endoleaks or complications. The mean follow-up period was 12 months in the patients who underwent BFG placement and 32 months in the patients who underwent AUI graft placement with CFFB. During these follow-up periods, there was 100% primary patency of successfully recanalized arteries and stent graft limbs. The aneurysm size decreased in four patients who underwent BFG; no change was seen in the other 11 patients. Type II endoleak from the lumbar artery was observed in one patient who underwent AUI stent graft placement with CFFB (Table III). Freedom from aneurysm-related events was 100%; no patients needed secondary intervention for endoleak or limb occlusion. All patients who complained of claudication preoperatively reported improvements in their symptoms at follow-up. Furthermore, ABI improved significantly from 0.51 6 0.25 preoperatively to 0.88 6 0.20 postoperatively (P < .001; Fig 2). The improvements in ABI were maintained during the follow-up period in all
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P < .001
Table II. Intraoperative variables for endovascular aneurysm repair (EVAR) with bifurcated stent graft (BFG; N ¼ 13) 228 6 64
Operative time, minutes
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1.2
0.51 0.25
0.88 0.20
Approach to the CTO lesiona Ipsilateral
9 (69)
Contralateral
4 (31)
1 0.8
Device of the main body Endurant
7 (54)
Excluder
6 (46)
0.6
13 (100)
0.4
CIA
5 (38)
0.2
EIA
8 (62)
Device of the contralateral leg Excluder Landing zone of the contralateral leg
0
Device placed for recanalized CTO lesions Covered stent
7 (54)
Covered stent þ lining BMS
2 (15)
BMS
4 (31)
Additional procedures Embolization of IIA
5 (38)
Embolization of IMA
1 (8)
Endarterectomy of CFA
1 (8)
Endowedge of renal artery
1 (8)
Proximal extension
1 (8)
Type I or type III endoleak
0 (0)
Complications Acute arterial occlusion
1 (8)
BMS, Bare-metal stent; CFA, common femoral artery; CIA, common iliac artery; CTO, chronic total occlusion; EIA, external iliac artery; IIA, internal iliac artery; IMA, inferior mesenteric artery. Categorical variables are presented as number (%). Continuous variables are presented as mean 6 standard deviation. a The side used for successful wire crossing of the CTO lesion. Ipsilateral indicates the side of the CTO vessel.
Table III. Postoperative outcomes BFG (n ¼ 13)
AUI stent graft þ CFFB (n ¼ 2)
Follow-up period, months
12 6 17
32 6 19
Patency
13 (100)
2 (100)
Reintervention
0 (0)
0 (0)
Postoperative endoleak
0 (0)
Shrinkage of aneurysmal sac
4 (31)
1 (50)a 0 (0)
AUI, Aortouni-iliac; BFG, bifurcated stent graft; CFFB, crossover femorofemoral bypass. Categorical variables are presented as number (%). Continuous variables are presented as mean 6 standard deviation. a Postoperative type II endoleak from the lumbar artery without aneurysmal enlargement was observed in one patient who underwent AUI stent graft placement with CFFB.
the cases. There were no amputations or deaths within 30 days of the procedures in these patients. One patient died during follow-up after 59 months of acute type A aortic dissection, and another patient died of malignant disease after 33 months.
Preop
3-month
Fig 2. Fluctuation of the mean ankle-brachial index (ABI) in patients who underwent bifurcated stent graft (BFG) placement, measured preoperatively and at 3 months postoperatively. The data were compared between the preoperative measurements and at 3 months postoperatively by Student t-test. Data are given as mean 6 standard deviation.
DISCUSSION Recanalization of the occluded iliac arteries and BFG placement have the advantages of preservation of hypogastric artery perfusion10,11 and lack of risk of femoral graft infection and occlusion12; in addition, there is only a small risk of hemodynamically significant steal of blood flow in the donor leg in these procedures.6 One of the potential complications is endograft limb occlusion in cases in which the recanalized lesions remain stenotic even if the lesions are dilated by stent graft limb or BMS. Several anatomic risk factors, such as calcification, angulation, presence of thrombus, and narrow diameter, and procedure-related risk factors, such as endograft oversizing and extension to the EIA, are predictors of limb occlusion.13-16 In this study, although there were extensions into the EIA in 8 of 13 patients (62%), limb occlusion was not seen in any of them. Treatment with a covered stent was reported to show no significant improvements in the primary patency rates compared with BMS for aortoiliac occlusive disease.17 Therefore, we did not extend the stent graft limb into the EIA to prevent limb occlusion and generally dilated the recanalized EIA by BMS as long as there was no CIA aneurysm and no possibility of rupture of the EIA. We used Excluder (W. L. Gore & Associates) legs for all EIAs because they are known to prevent kinks and to reduce limb occlusion.18 We believe these strategies led to the favorable outcomes of 100% patency and ABI restoration. The aneurysmal outcomes were also satisfactory with permissible occurrence of endoleaks and shrinkage of the sacs. We believe that the recanalization of CTO
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lesions in the access route with subsequent BFG placement is durable and effective enough to treat the concomitant aneurysmal disease and iliac CTO lesions as was reported by another study.9 Our technical success rate was 87%, and 2 of 15 patients (13%) had technical failure due to disabling of wire crossing of the CTO lesions. These patients had several features that might have contributed to the failure. One patient had occlusion with localized dissection as observed on preoperative CTA. We recognized calcification within the thrombotic occlusive vessel, not around the vessel, as the calcified endothelium that was separated from the vessel walldin other words, occlusion based on the localized dissection. The other patient had severe tortuosity and excessive diffuse calcification along the occlusive vessel. In these cases, we believe that the guidewire may have strayed into the subintimal layer. It is difficult to determine whether these features were the risk factors for the technical failure because recanalization was achieved in some cases even with these features. Therefore, we cannot abandon the endovascular approach on the basis of the findings of preoperative CTA. The field of endovascular surgery is rapidly progressing, and recent improvements in the devices and the increased experience of the interventionists have enabled the use of endovascular therapy for extensive iliac artery occlusive disease.19-21 There is the possibility of complications, such as artery rupture and distal embolism, during the procedure of recanalization.22,23 Although we did not experience obvious iliac artery rupture in this study, we were prepared for this possibility, for which an occlusion balloon is inserted from the contralateral side to occlude the vessel proximal to the rupture site in high-risk cases of rupture. Moreover, distal embolism occurred in one case in our study. We performed predilation for the recanalized CTO lesions before the insertion of 12F sheaths in two cases, and of them, one developed distal embolism in the superficial femoral artery. Although this maneuver is sometimes inevitably required for the insertion of large sheaths, it is better not to perform predilation for the plaque-rich CTO lesion before insertion of the large sheath if possible. Furthermore, recanalization of CTO in the CIA also has the risk of distal thrombus embolization to the IIA, which can cause buttock necrosis; however, we did not encounter it in this study. To prevent this complication, embolic protection filter devices are being developed but are not yet in general use. Further research is required to overcome the problem of distal embolism. Our study has some limitations. The number of patients was small, and there was a short follow-up period. Further investigations are warranted to corroborate our findings. Nevertheless, there are no reports larger than ours in terms of the sample size and short-term outcomes. Furthermore, it is relatively easy to perform additional procedures if the necessity arises for secondary interventions in the future.
CONCLUSIONS Recanalization of iliac CTO lesions and placement of a BFG in cases with concomitant aneurysmal disease and unilateral iliac occlusive disease demonstrated significant primary patency rate along with restoration of claudication and ABI. Therefore, this is a promising treatment option in these patients.
AUTHOR CONTRIBUTIONS Conception and design: NM, KS, KH Analysis and interpretation: YT, NM Data collection: YT, TM, TN, MS, KU Writing the article: YT Critical revision of the article: NM, TM, TN, MS, KU, KS, KH Final approval of the article: YT, NM, TM, TN, MS, KU, KS, KH Statistical analysis: YT Obtained funding: Not applicable Overall responsibility: KH
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12. Donor limb vascular events following femoro-femoral bypass surgery. A Veterans Affairs Cooperative Study. Arch Surg 1991;126:681-5. 13. Taudorf M, Jensen LP, Vogt KC, Gronvall J, Schroeder TV, Lonn L. Endograft limb occlusion in EVAR: iliac tortuosity quantified by three different indices on the basis of preoperative CTA. Eur J Vasc Endovasc Surg 2014;48:527-33. 14. Mantas GK, Antonopoulos CN, Sfyroeras GS, Moulakakis KG, Kakisis JD, Mylonas SN, et al. Factors predisposing to endograft limb occlusion after endovascular aortic repair. Eur J Vasc Endovasc Surg 2015;49:39-44. 15. Cochennec F, Becquemin JP, Desgranges P, Allaire E, Kobeiter H, Roudot-Thoraval F. Limb graft occlusion following EVAR: clinical pattern, outcomes and predictive factors of occurrence. Eur J Vasc Endovasc Surg 2007;34: 59-65. 16. Carroccio A, Faries PL, Morrissey NJ, Teodorescu V, Burks JA, Gravereaux EC, et al. Predicting iliac limb occlusions after bifurcated aortic stent grafting: anatomic and devicerelated causes. J Vasc Surg 2002;36:679-84. 17. Hajibandeh S, Hajibandeh S, Antoniou SA, Torella F, Antoniou GA. Covered vs uncovered stents for aortoiliac and femoropopliteal arterial disease: a systematic review and meta-analysis. J Endovasc Ther 2016;23:442-52.
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Submitted Mar 20, 2018; accepted Aug 29, 2018.