Clinical Research Article
Trans-Atlantic Inter-Society Consensus II C and D Iliac Lesions Can Be Treated by Endovascular and Hybrid Approach: A Single-Center Experience
Vascular and Endovascular Surgery 2014, Vol 48(2) 123-128 ª The Author(s) 2013 Reprints and permission: sagepub.com/journalsPermissions.nav DOI: 10.1177/1538574413512381 ves.sagepub.com
Maurizio Taurino, MD1, Francesca Persiani, MD1, Cristiano Fantozzi, MD1, Roberta Ficarelli, MD1, Luigi Rizzo, MD1, and Nazzareno Stella, MD1
Abstract Purpose: To evaluate the long-term results of endovascular and hybrid treatment in patients with Trans-Atlantic Inter-Society Consensus (TASC) II type ‘‘C’’ and ‘‘D’’ aortoiliac lesions and to highlight, in contrast to TASC II guidelines, the importance to analyze individually the lesions of a single iliac axis. Methods: From January 2008 to December 2012, 50 patients with TASC II type C and D aortoiliac lesions underwent endovascular or hybrid treatment. In 38 patients (76%), the lesions were treated by endovascular approach, while in 12 (24%) patients surgical treatment was adopted. All patients underwent a postoperative surveillance program at 1, 3, and 6 months for the first year and every 6 months thereafter. Results: Technical success was achieved in all patients (100%). The postoperative complication rate was 4%. Primary patency rate was 93.3% at 1 year, 90.2% at 2 years, and 86.6% at 3 years. Cumulative secondary patency rate was 97.7% at 1, 2, and 3 years. Survival after 1 and 2 years was 94.8% and after 3 years was 91.1%. Limb salvage was 100% for the entire period of follow-up. Conclusions: In contrast to TASC II guidelines, the endovascular or hybrid treatment should be considered a valid approach for type C and D lesions. The hybrid treatment, in selected cases, is an effective method to improve the runoff, which plays a key role in the success of the treatment of multilevel stenoocclusive lesions. In TASC II C to D iliac lesions, a specific overview of each axis is necessary in order to select the most appropriate treatment. Keywords peripheral occlusive diseases, aortoiliac TASC II type C and D lesions, endovascular treatment, hybrid treatment
Introduction In the past years, endovascular technique gradually became the treatment of choice for the most peripheral atherosclerotic lesions even for aortoiliac lesions, and it also paved the way for the hybrid treatment. Currently, the guidelines on peripheral occlusive diseases are described in the Trans-Atlantic Inter-Society Consensus (TASC) II (Inter-Society Consensus for the Management of Peripheral Arterial Disease), published in 2007.1 This classification provides indications for the best treatment of the aortoiliac district lesions, according to the location and the type of the lesion. Based on the TASC II criteria, for type ‘‘D’’ lesions, the treatment of choice is surgery. While for type ‘‘C’’ lesions, as satisfactory long-term results following surgical revascularization have been obtained, the endovascular treatment should be reserved only for patients at high surgical risk.1 However, additional parameters should be considered in the choice of the best treatment for each patient, such as
comorbidities and the steady development and availability of the new materials. For this reason, it is common behavior to extend the choice of endovascular therapy also for lesions of type ‘‘C’’ and ‘‘D.’’ The aim of our study is to evaluate the mid-long-term outcomes of endovascular and hybrid treatment in patients with aortoiliac TASC II type ‘‘C’’ and ‘‘D’’ occlusive disease. Particularly, same specific parameters, such as immediate technical success, long-distance patency, and limb-salvage rate, have been taken into consideration.
1
Department of Vascular Surgery, Sant’Andrea Hospital, University of Rome– ‘‘La Sapienza’’, Rome, Italy Corresponding Author: Francesca Persiani, Department of Vascular Surgery, Sant’Andrea Hospital, University of Rome–‘‘La Sapienza’’, Rome, Italy. Email: [email protected]
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Table 1. Demographic Characteristics and Risk Factors. Endovascular Group (N ¼ 38)
Median age Male sex Smoking Hypertension Hyperlipidemia Diabetes mellitus Coronary artery disease Kidney dysfunction COPD
Hybrid Group (N ¼ 12)
n
%
n
%
P Value
64 29 26 31 23 11 8 3 12
73.6 68.4 81.6 60.5 28.9 21 7.9 31.6
65 11 10 11 8 4 3 2 7
91.7 83.3 91.7 66.7 33.3 25 16.7 58.3
NS NS NS NS NS NS NS NS
Abbreviations: COPD, chronic obstructive pulmonary disease; NS, not significant.
Table 2. Clinical Classification. Fontaine Stage
Clinical
I IIa IIb
Asymptomatic Mild claudication Moderate–severe claudication
III IV
Ischemic rest pain Ischemic ulcers or gangrene
Rutherford Category 0 1 2 3 4 5 6
Endovascular Group, N ¼ 38 (%)
Clinical Asymptomatic Mild claudication Moderate claudication Severe claudication Ischemic rest pain Minor and major tissue loss
0 4 6 18 4 6
Hybrid Group, N ¼ 12(%)
(0) (10.5) (15.8) (47.4) (10.5) (15.8)
0 1 1 2 4 4
(0) (8.3) (8.3) (16.6) (33.4) (33.4)
P Value NS NS NS NS .017
Abbreviation: NS, not significant.
Methods Patient Population
Table 3. Types of Open and Endovascular Procedures.
Prospectively collected data were retrospectively reviewed on 50 patients who, from January 2008 to December 2012, underwent endovascular procedure for the treatment of aortoiliac occlusive disease, classified as TASC II types C and D lesions. The patient population consisted of 40 men (80%) and 10 women (20%); the average age was 64 (range 40-87). The demographic characteristics and risk factors are shown in Table 1. Patients with acute ischemia, aneurysm, and pseudoaneurysm were excluded from this analysis. According to the Rutherford grading, 18 (36%) patients had critical limb ischemia (8 patients had persisting rest pain and 10 patients had tissue losses); the remaining 64% of patients showed intermittent claudication, and 84.4% of them showed a severe reduction in pain while walking. The clinical features are shown in Table 2. Trans-Atlantic Inter-Society Consensus II classification was type C in 14 (28%) patients and type D in 36 (72%) patients. All patients underwent preoperative peripheral arterial evaluation with color duplex ultrasonography, measurement of ankle– brachial index (ABI), and computed tomography angiography or magnetic resonance angiography. The average follow-up period was 31 months (range 1-59 months).
Endovascular procedure TA/stent CIA TA/stent EIA TA/stent CIA EIA Kissing stent CIA Kissing stent EIA IIA Associated open procedure Femoral bifurcation endarterectomy EIA remote endarterectomy þ Femoral bifurcation endarterectomy
N 4 13 12 7 1 4 6
Abbreviations: TA, transluminal angioplasty; CIA, common iliac artery; EIA, external iliac artery; IIA, internal iliac artery.
Endovascular and Hybrid Treatment Of the 50 patients, 38 (76%) were treated by endovascular approach and the remaining 12 (24%) patients by hybrid treatment. These procedures are shown in Table 3. All the endovascular acts were performed under local anesthesia by means of femoral puncture. The technique for recanalization was either an anterograde or a retrograde approach, through unilateral femoral access or multiple access sites, such as the bilateral femoral or femoral/
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Table 4. Types of Stents Used. Balloon-expandable stents (35.4%) Express (Boston Scientific) Genesis (Cordis) Primus GPS (eV3) Omnilink (Guidant) Astron Pulsar (Biotronik) Self-expandable stents (64.6%) Wallstent (Boston Scientific) Protege` (eV3) Lifestent (Bard)
brachial. A subintimal angioplasty was carried out only in 2 patients. Any hybrid procedure was completely planned preoperatively and was performed under regional anesthesia. The open arterial reconstruction (femoral endarterectomy with or without remote iliac artery endarterectomy by means of Vollmar ring technique) was performed first followed by endovascular recanalization of the ipsilateral iliac axis, through direct puncture of the prosthetic material. In all, 96 stents were used in 50 patients, of which 62 (64.6%) were self-expanding nitinol stents and the remaining 34 (35.4%) stents were balloon expandable. The different types of stents are shown in Table 4. For 6 months after the procedures, all patients received a dual antiplatelet therapy (acetylsalicylic 100 mg and clopidogrel 75 mg), followed by a single-agent therapy. For patients presenting with or critical limb ischemia and or severe impairment of outflow, low-molecular-weight heparin was administrated for about 1 month following the intervention.
Follow-Up Protocol After surgery, all patients underwent a postoperative surveillance program at 1, 3, and 6 months for the first year and every 6 months, thereafter. The follow-up protocol included assessment of symptoms, clinical examination, ABI, and color duplex ultrasonography of abdominal aorta, iliac axes, and lower limbs. For patients with restenosis >50% or de novo lesions identified by color duplex ultrasonography, a computed tomographic angiography or angiography was performed to confirm the lesion. If the lesion or occlusion was confirmed, the reintervention was planned.
Statistical Analysis Long-term patency and survival rates were determined using the Kaplan-Meier analysis, and the patency curves for the endovascular and hybrid groups were compared by using the log-rank test. The Fisher exact test was used to compare the 2 groups. Individual differences were considered to be statistically significant for values of P < .05. All statistical tests were performed using SPSS for Windows version 19 (SPSS; IBM, New York).
Figure 1. Kaplan-Meier curves for primary patency.
Results Initial Results Technical success was achieved in all patients (100%). The mean ABI value increased from 0.28 to 0.74 after the successful treatment. Intraoperative complications occurred in 10 (20%) patients. Flow-limiting dissections occurred in 7 (14%) patients and were simultaneously corrected with stent placement; 3 (6%) patients of distal embolization were successfully treated by Fogarty thromboembolectomy. Of these 10 intraoperative complications, 9 occurred during endovascular procedure and only 1 occurred in patients treated with hybrid approach. Postoperative complications (within 30 days after surgery) included 1 (2%) case of pseudoaneurysm at the access site and 1 (2%) case of suture hole bleeding, secondary to hybrid approach, successfully treated with open surgery. No significant difference in arising of periprocedural complications was registered between the 2 groups (P ¼ .7). No periprocedural deaths were observed. A significant difference was observed in the number of patients that had critical ischemia between the 2 groups (P ¼ .017): 10 patients (26.32%) in the endovascular group and 8 (66.72%) in the hybrid one.
Long-Term Results Primary patency rates observed at 1, 2, and 3 years were 93.3%, 90.2%, and 86.6% in TASC II C/D (Figure 1). Comparing the
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Figure 4. Kaplan-Meier curves for the limb salvage. Figure 2. Kaplan-Meier curves for secondary patency.
Figure 3. Kaplan-Meier curves depicting survival.
2 groups, in the endovascular one, primary patency was 93.6% at 1 year and 89.4% at 2 and 3 years and in hybrid group was 91.7% at 1 and 2 years and 80.2% at 3 years (Figure 2). No significant difference in cumulative primary patency rates was seen between endovascular and hybrid groups (P ¼ .14). Cumulative secondary patency rate was 97.7% at 1, 2, and 3 years (Figure 1). Secondary patency was 96.9% at 1, 2, and 3 years in endovascular group and 100% at 1, 2, and 3 years in hybrid group (Figure 3). Again, no significant difference was identified between the 2 groups (P ¼ 1). During the follow-up period, 3 (6%) patients died of no related vascular disease. Overall survival after 1 and 2 years was 94.8% and after 3 years was 91.1% (Figure 4). Limb salvage was 100% for the entire period of follow-up (Figure 4). One (2%) patient developed a stent thrombosis at 4 months. An endovascular attempt has been tried unsuccessfully and the patient underwent a successful crossover femorofemoral bypass. Two (4%) patients of ‘‘early’’ stent thrombosis at 1 and 7 months have been observed. These patients were, respectively, treated with only locoregional thrombolytic therapy or with thrombolytic therapy and balloon angioplasty with good results. Three patients of ‘‘late’’ stent thrombosis (6%) at 22, 30, and 58 months were successfully treated with balloon angioplasty and stenting.
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Primary assisted patency rate coincided with primary patency.
Discussion It has been widely demonstrated how the endovascular approach may be a valuable choice for the treatment of focal lesions of the aortoiliac district, characterized by concentric fibrous plaque and with a good runoff.2 On the contrary, the initial results reached with recanalization of iliac occlusions were not in favor of this technique, particularly for the high incidence of embolic complications.3 The TASC II1 summarizes these results, showing endovascular approach as the treatment of choice for TASC II A lesions and surgery for TASC II D lesions; for TASC II B and C lesions the best treatment is, respectively, endovascular and surgical. Since the publication of the first TASC, many authors have dedicated their efforts to discuss these guidelines also in international debates. In 2003, Timaran and colleagues4 published an experience, mostly conforming the choice of open treatment for lesions type C and D, in line with the TASC. On the contrary, in the following years, the interest in the endovascular treatment has progressively grown. This change was due to the higher operators experience, the development of endovascular materials and the advantages offered by the endovascular procedure. LeVille and colleagues5 in 2006 published a retrospective study where aortoiliac lesions TASC B, C, and D were examined and treated with the endovascular technique reporting a 95% technical success, 73% and 80% primary patency, 93% and 83% secondary patency, respectively, for type C and D lesions with a 3-year follow-up. In 2008, a study published by Hans and colleagues6 compared the endovascular treatment with the surgical one for the aortoiliac lesions TASC C and D. They obtained good results with both techniques. However, they underlined a lower rate of primary patency (69% vs 93%) in patients submitted to endovascular treatment and a reduction in the postoperative morbidity together with a reduction in hospital stay. In both studies, in order to indicate the best treatment, the importance of the outflow and the preoperative planning was highlighted. The peculiarity of the hybrid treatment lies on its ability to provide the resolution of the stenoocclusive lesions, ensuring a positive runoff in order to obtain a good result in terms of longdistance patency. In their study in 1989, Brewster and colleagues7 have reported good long-term patency in patients treated with angioplasty for iliac axis occlusions, and distal revascularization by means of an open treatment. In their study, they recorded a 5-year primary patency rate of 76% and a primary assisted patency rate of 88%. In 2008, Chang and colleagues8 reported an experience about the hybrid treatment of the iliac axis by means of thromboendarterectomy of the femoral artery associated with stenting of the iliac axis, obtaining at 5 years a primary patency of 60%, a primary-assisted patency of 97%, and a secondary patency of 98%.
More recently, a study by Piazza and colleagues9 compared the hybrid approach, the iliac stenting, and femoral thromboendarterectomy, with the open technique. This article showed that, in TASC II C and D lesions, the primary patency at 3 years is similar in the 2 groups (95% with the hybrid technique and 97% with the open technique). They concluded that it is necessary to take into account the hybrid treatment for all patients with severe obstructive lesions, especially for those with a high surgical risk. Regarding our experience, we achieved a technical success rate of 100%, a cumulative primary patency rates of 93.3% at 1 year, 90.2% at 2 years, and 86.6% at 3 years. The secondary patency was 97.7% at 1, 2, and 3 years. In our series, for lesions with a patent outflow, it is necessary to treat only the iliac lesion by means of the endovascular technique. On the other hand, for more complex lesions characterized by an impairment of the outflow, the mid-long-term patency has been determined by the improvement in runoff having chosen the hybrid approach.
Conclusion On the basis of the results, the endovascular treatment for severe aortoiliac lesions can be considered a procedure with a high rate of technical success, based on midlong-term patency and limb salvage. So, in contrast to TASC II guidelines, the endovascular treatment should be considered a valid approach even for lesions of type C and D. The hybrid treatment, in selected patients, seems to be an effective method in order to treat multilevel stenoocclusive lesions, limiting the surgical cutdown to a single district, reducing the complexity of any surgical intervention, and providing a better runoff than the only endovascular treatment. For choosing the best approach, an adequate and careful preoperative evaluation including the study of the characteristics of each lesion and the condition of the outflow is necessary. Declaration of Conflicting Interests The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Funding The author(s) received no financial support for the research, authorship, and/or publication of this article.
References 1. Norgren L, Hiatt WR, Dormandy JA, Nehler MR, Harris KA, Fowkes FG. Inter–society consensus for the management of peripheral arterial disease (TASC II). J Vasc Surg. 2007;45(suppl S): S5-S67. 2. Bosch JL, Hunink MG. Meta-analysis of the results of percutaneous transluminal angioplasty and stent placement for aortoiliac occlusive disease. Radiology. 1997;204:87-96. 3. Ring EJ, Freiman DB, Mc Lean GK, Svhwarz W. Percutaneus recanalizazion of common iliac artery occlusions: an unacceptable complication rate? AJR Am J Roentgenol. 1982;139(3): 587-589.
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4. Timaran CH, Prault TL, Stevens SL, Freeman MB, Goldman MH. Iliac artery stenting versus surgical reconstruction for TASC (TransAtlantic inter-society consensus) type B and type C iliac lesions. J Vasc Surg. 2003;38(2):272-278. 5. LeVille CD, Kashyap VS, Clair DG, Bena JF, Leyden SP, et al. Endovascular management of iliac artery occlusion: extending treatment to transatlantic inter-society consensus class C and D patients. J Vasc Surg. 2006;43(1):32-39. 6. Hans SS, DeSantis D, Siddiqui R, Khoury M. Results of endovascular therapy and aortobifemoral grafting for Transatlantic Inter-Society type C and D aortoiliac occlusive disease. Surgery. 2008;144(4):583-589.
7. Brewster DC, Cambria RP, Darling RC, et al. Long-term results of combined iliac balloon angioplasty and distal surgical revascularization. Ann Surg. 1989;210(3):324-330. 8. 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(2):362-367. 9. Piazza M, Ricotta JJ II, Bower TC, et al. Iliac artery stenting combined with open femoral endarterectomy is as effective as open surgical reconstruction for severe iliac and common femoral occlusive disease. J Vasc Surg. 2011;54(2):402-411.
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Trans-Atlantic Inter-Society Consensus II C and D Iliac Lesions Can Be Treated by Endovascular and Hybrid Approach: A Single-Center Experience
Vascular and Endovascular Surgery 2014, Vol 48(2) 123-128 ª The Author(s) 2013 Reprints and permission: sagepub.com/journalsPermissions.nav DOI: 10.1177/1538574413512381 ves.sagepub.com
Maurizio Taurino, MD1, Francesca Persiani, MD1, Cristiano Fantozzi, MD1, Roberta Ficarelli, MD1, Luigi Rizzo, MD1, and Nazzareno Stella, MD1
Abstract Purpose: To evaluate the long-term results of endovascular and hybrid treatment in patients with Trans-Atlantic Inter-Society Consensus (TASC) II type ‘‘C’’ and ‘‘D’’ aortoiliac lesions and to highlight, in contrast to TASC II guidelines, the importance to analyze individually the lesions of a single iliac axis. Methods: From January 2008 to December 2012, 50 patients with TASC II type C and D aortoiliac lesions underwent endovascular or hybrid treatment. In 38 patients (76%), the lesions were treated by endovascular approach, while in 12 (24%) patients surgical treatment was adopted. All patients underwent a postoperative surveillance program at 1, 3, and 6 months for the first year and every 6 months thereafter. Results: Technical success was achieved in all patients (100%). The postoperative complication rate was 4%. Primary patency rate was 93.3% at 1 year, 90.2% at 2 years, and 86.6% at 3 years. Cumulative secondary patency rate was 97.7% at 1, 2, and 3 years. Survival after 1 and 2 years was 94.8% and after 3 years was 91.1%. Limb salvage was 100% for the entire period of follow-up. Conclusions: In contrast to TASC II guidelines, the endovascular or hybrid treatment should be considered a valid approach for type C and D lesions. The hybrid treatment, in selected cases, is an effective method to improve the runoff, which plays a key role in the success of the treatment of multilevel stenoocclusive lesions. In TASC II C to D iliac lesions, a specific overview of each axis is necessary in order to select the most appropriate treatment. Keywords peripheral occlusive diseases, aortoiliac TASC II type C and D lesions, endovascular treatment, hybrid treatment
Introduction In the past years, endovascular technique gradually became the treatment of choice for the most peripheral atherosclerotic lesions even for aortoiliac lesions, and it also paved the way for the hybrid treatment. Currently, the guidelines on peripheral occlusive diseases are described in the Trans-Atlantic Inter-Society Consensus (TASC) II (Inter-Society Consensus for the Management of Peripheral Arterial Disease), published in 2007.1 This classification provides indications for the best treatment of the aortoiliac district lesions, according to the location and the type of the lesion. Based on the TASC II criteria, for type ‘‘D’’ lesions, the treatment of choice is surgery. While for type ‘‘C’’ lesions, as satisfactory long-term results following surgical revascularization have been obtained, the endovascular treatment should be reserved only for patients at high surgical risk.1 However, additional parameters should be considered in the choice of the best treatment for each patient, such as
comorbidities and the steady development and availability of the new materials. For this reason, it is common behavior to extend the choice of endovascular therapy also for lesions of type ‘‘C’’ and ‘‘D.’’ The aim of our study is to evaluate the mid-long-term outcomes of endovascular and hybrid treatment in patients with aortoiliac TASC II type ‘‘C’’ and ‘‘D’’ occlusive disease. Particularly, same specific parameters, such as immediate technical success, long-distance patency, and limb-salvage rate, have been taken into consideration.
1
Department of Vascular Surgery, Sant’Andrea Hospital, University of Rome– ‘‘La Sapienza’’, Rome, Italy Corresponding Author: Francesca Persiani, Department of Vascular Surgery, Sant’Andrea Hospital, University of Rome–‘‘La Sapienza’’, Rome, Italy. Email: [email protected]
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Table 1. Demographic Characteristics and Risk Factors. Endovascular Group (N ¼ 38)
Median age Male sex Smoking Hypertension Hyperlipidemia Diabetes mellitus Coronary artery disease Kidney dysfunction COPD
Hybrid Group (N ¼ 12)
n
%
n
%
P Value
64 29 26 31 23 11 8 3 12
73.6 68.4 81.6 60.5 28.9 21 7.9 31.6
65 11 10 11 8 4 3 2 7
91.7 83.3 91.7 66.7 33.3 25 16.7 58.3
NS NS NS NS NS NS NS NS
Abbreviations: COPD, chronic obstructive pulmonary disease; NS, not significant.
Table 2. Clinical Classification. Fontaine Stage
Clinical
I IIa IIb
Asymptomatic Mild claudication Moderate–severe claudication
III IV
Ischemic rest pain Ischemic ulcers or gangrene
Rutherford Category 0 1 2 3 4 5 6
Endovascular Group, N ¼ 38 (%)
Clinical Asymptomatic Mild claudication Moderate claudication Severe claudication Ischemic rest pain Minor and major tissue loss
0 4 6 18 4 6
Hybrid Group, N ¼ 12(%)
(0) (10.5) (15.8) (47.4) (10.5) (15.8)
0 1 1 2 4 4
(0) (8.3) (8.3) (16.6) (33.4) (33.4)
P Value NS NS NS NS .017
Abbreviation: NS, not significant.
Methods Patient Population
Table 3. Types of Open and Endovascular Procedures.
Prospectively collected data were retrospectively reviewed on 50 patients who, from January 2008 to December 2012, underwent endovascular procedure for the treatment of aortoiliac occlusive disease, classified as TASC II types C and D lesions. The patient population consisted of 40 men (80%) and 10 women (20%); the average age was 64 (range 40-87). The demographic characteristics and risk factors are shown in Table 1. Patients with acute ischemia, aneurysm, and pseudoaneurysm were excluded from this analysis. According to the Rutherford grading, 18 (36%) patients had critical limb ischemia (8 patients had persisting rest pain and 10 patients had tissue losses); the remaining 64% of patients showed intermittent claudication, and 84.4% of them showed a severe reduction in pain while walking. The clinical features are shown in Table 2. Trans-Atlantic Inter-Society Consensus II classification was type C in 14 (28%) patients and type D in 36 (72%) patients. All patients underwent preoperative peripheral arterial evaluation with color duplex ultrasonography, measurement of ankle– brachial index (ABI), and computed tomography angiography or magnetic resonance angiography. The average follow-up period was 31 months (range 1-59 months).
Endovascular procedure TA/stent CIA TA/stent EIA TA/stent CIA EIA Kissing stent CIA Kissing stent EIA IIA Associated open procedure Femoral bifurcation endarterectomy EIA remote endarterectomy þ Femoral bifurcation endarterectomy
N 4 13 12 7 1 4 6
Abbreviations: TA, transluminal angioplasty; CIA, common iliac artery; EIA, external iliac artery; IIA, internal iliac artery.
Endovascular and Hybrid Treatment Of the 50 patients, 38 (76%) were treated by endovascular approach and the remaining 12 (24%) patients by hybrid treatment. These procedures are shown in Table 3. All the endovascular acts were performed under local anesthesia by means of femoral puncture. The technique for recanalization was either an anterograde or a retrograde approach, through unilateral femoral access or multiple access sites, such as the bilateral femoral or femoral/
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Table 4. Types of Stents Used. Balloon-expandable stents (35.4%) Express (Boston Scientific) Genesis (Cordis) Primus GPS (eV3) Omnilink (Guidant) Astron Pulsar (Biotronik) Self-expandable stents (64.6%) Wallstent (Boston Scientific) Protege` (eV3) Lifestent (Bard)
brachial. A subintimal angioplasty was carried out only in 2 patients. Any hybrid procedure was completely planned preoperatively and was performed under regional anesthesia. The open arterial reconstruction (femoral endarterectomy with or without remote iliac artery endarterectomy by means of Vollmar ring technique) was performed first followed by endovascular recanalization of the ipsilateral iliac axis, through direct puncture of the prosthetic material. In all, 96 stents were used in 50 patients, of which 62 (64.6%) were self-expanding nitinol stents and the remaining 34 (35.4%) stents were balloon expandable. The different types of stents are shown in Table 4. For 6 months after the procedures, all patients received a dual antiplatelet therapy (acetylsalicylic 100 mg and clopidogrel 75 mg), followed by a single-agent therapy. For patients presenting with or critical limb ischemia and or severe impairment of outflow, low-molecular-weight heparin was administrated for about 1 month following the intervention.
Follow-Up Protocol After surgery, all patients underwent a postoperative surveillance program at 1, 3, and 6 months for the first year and every 6 months, thereafter. The follow-up protocol included assessment of symptoms, clinical examination, ABI, and color duplex ultrasonography of abdominal aorta, iliac axes, and lower limbs. For patients with restenosis >50% or de novo lesions identified by color duplex ultrasonography, a computed tomographic angiography or angiography was performed to confirm the lesion. If the lesion or occlusion was confirmed, the reintervention was planned.
Statistical Analysis Long-term patency and survival rates were determined using the Kaplan-Meier analysis, and the patency curves for the endovascular and hybrid groups were compared by using the log-rank test. The Fisher exact test was used to compare the 2 groups. Individual differences were considered to be statistically significant for values of P < .05. All statistical tests were performed using SPSS for Windows version 19 (SPSS; IBM, New York).
Figure 1. Kaplan-Meier curves for primary patency.
Results Initial Results Technical success was achieved in all patients (100%). The mean ABI value increased from 0.28 to 0.74 after the successful treatment. Intraoperative complications occurred in 10 (20%) patients. Flow-limiting dissections occurred in 7 (14%) patients and were simultaneously corrected with stent placement; 3 (6%) patients of distal embolization were successfully treated by Fogarty thromboembolectomy. Of these 10 intraoperative complications, 9 occurred during endovascular procedure and only 1 occurred in patients treated with hybrid approach. Postoperative complications (within 30 days after surgery) included 1 (2%) case of pseudoaneurysm at the access site and 1 (2%) case of suture hole bleeding, secondary to hybrid approach, successfully treated with open surgery. No significant difference in arising of periprocedural complications was registered between the 2 groups (P ¼ .7). No periprocedural deaths were observed. A significant difference was observed in the number of patients that had critical ischemia between the 2 groups (P ¼ .017): 10 patients (26.32%) in the endovascular group and 8 (66.72%) in the hybrid one.
Long-Term Results Primary patency rates observed at 1, 2, and 3 years were 93.3%, 90.2%, and 86.6% in TASC II C/D (Figure 1). Comparing the
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Figure 4. Kaplan-Meier curves for the limb salvage. Figure 2. Kaplan-Meier curves for secondary patency.
Figure 3. Kaplan-Meier curves depicting survival.
2 groups, in the endovascular one, primary patency was 93.6% at 1 year and 89.4% at 2 and 3 years and in hybrid group was 91.7% at 1 and 2 years and 80.2% at 3 years (Figure 2). No significant difference in cumulative primary patency rates was seen between endovascular and hybrid groups (P ¼ .14). Cumulative secondary patency rate was 97.7% at 1, 2, and 3 years (Figure 1). Secondary patency was 96.9% at 1, 2, and 3 years in endovascular group and 100% at 1, 2, and 3 years in hybrid group (Figure 3). Again, no significant difference was identified between the 2 groups (P ¼ 1). During the follow-up period, 3 (6%) patients died of no related vascular disease. Overall survival after 1 and 2 years was 94.8% and after 3 years was 91.1% (Figure 4). Limb salvage was 100% for the entire period of follow-up (Figure 4). One (2%) patient developed a stent thrombosis at 4 months. An endovascular attempt has been tried unsuccessfully and the patient underwent a successful crossover femorofemoral bypass. Two (4%) patients of ‘‘early’’ stent thrombosis at 1 and 7 months have been observed. These patients were, respectively, treated with only locoregional thrombolytic therapy or with thrombolytic therapy and balloon angioplasty with good results. Three patients of ‘‘late’’ stent thrombosis (6%) at 22, 30, and 58 months were successfully treated with balloon angioplasty and stenting.
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Primary assisted patency rate coincided with primary patency.
Discussion It has been widely demonstrated how the endovascular approach may be a valuable choice for the treatment of focal lesions of the aortoiliac district, characterized by concentric fibrous plaque and with a good runoff.2 On the contrary, the initial results reached with recanalization of iliac occlusions were not in favor of this technique, particularly for the high incidence of embolic complications.3 The TASC II1 summarizes these results, showing endovascular approach as the treatment of choice for TASC II A lesions and surgery for TASC II D lesions; for TASC II B and C lesions the best treatment is, respectively, endovascular and surgical. Since the publication of the first TASC, many authors have dedicated their efforts to discuss these guidelines also in international debates. In 2003, Timaran and colleagues4 published an experience, mostly conforming the choice of open treatment for lesions type C and D, in line with the TASC. On the contrary, in the following years, the interest in the endovascular treatment has progressively grown. This change was due to the higher operators experience, the development of endovascular materials and the advantages offered by the endovascular procedure. LeVille and colleagues5 in 2006 published a retrospective study where aortoiliac lesions TASC B, C, and D were examined and treated with the endovascular technique reporting a 95% technical success, 73% and 80% primary patency, 93% and 83% secondary patency, respectively, for type C and D lesions with a 3-year follow-up. In 2008, a study published by Hans and colleagues6 compared the endovascular treatment with the surgical one for the aortoiliac lesions TASC C and D. They obtained good results with both techniques. However, they underlined a lower rate of primary patency (69% vs 93%) in patients submitted to endovascular treatment and a reduction in the postoperative morbidity together with a reduction in hospital stay. In both studies, in order to indicate the best treatment, the importance of the outflow and the preoperative planning was highlighted. The peculiarity of the hybrid treatment lies on its ability to provide the resolution of the stenoocclusive lesions, ensuring a positive runoff in order to obtain a good result in terms of longdistance patency. In their study in 1989, Brewster and colleagues7 have reported good long-term patency in patients treated with angioplasty for iliac axis occlusions, and distal revascularization by means of an open treatment. In their study, they recorded a 5-year primary patency rate of 76% and a primary assisted patency rate of 88%. In 2008, Chang and colleagues8 reported an experience about the hybrid treatment of the iliac axis by means of thromboendarterectomy of the femoral artery associated with stenting of the iliac axis, obtaining at 5 years a primary patency of 60%, a primary-assisted patency of 97%, and a secondary patency of 98%.
More recently, a study by Piazza and colleagues9 compared the hybrid approach, the iliac stenting, and femoral thromboendarterectomy, with the open technique. This article showed that, in TASC II C and D lesions, the primary patency at 3 years is similar in the 2 groups (95% with the hybrid technique and 97% with the open technique). They concluded that it is necessary to take into account the hybrid treatment for all patients with severe obstructive lesions, especially for those with a high surgical risk. Regarding our experience, we achieved a technical success rate of 100%, a cumulative primary patency rates of 93.3% at 1 year, 90.2% at 2 years, and 86.6% at 3 years. The secondary patency was 97.7% at 1, 2, and 3 years. In our series, for lesions with a patent outflow, it is necessary to treat only the iliac lesion by means of the endovascular technique. On the other hand, for more complex lesions characterized by an impairment of the outflow, the mid-long-term patency has been determined by the improvement in runoff having chosen the hybrid approach.
Conclusion On the basis of the results, the endovascular treatment for severe aortoiliac lesions can be considered a procedure with a high rate of technical success, based on midlong-term patency and limb salvage. So, in contrast to TASC II guidelines, the endovascular treatment should be considered a valid approach even for lesions of type C and D. The hybrid treatment, in selected patients, seems to be an effective method in order to treat multilevel stenoocclusive lesions, limiting the surgical cutdown to a single district, reducing the complexity of any surgical intervention, and providing a better runoff than the only endovascular treatment. For choosing the best approach, an adequate and careful preoperative evaluation including the study of the characteristics of each lesion and the condition of the outflow is necessary. Declaration of Conflicting Interests The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Funding The author(s) received no financial support for the research, authorship, and/or publication of this article.
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7. Brewster DC, Cambria RP, Darling RC, et al. Long-term results of combined iliac balloon angioplasty and distal surgical revascularization. Ann Surg. 1989;210(3):324-330. 8. 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(2):362-367. 9. Piazza M, Ricotta JJ II, Bower TC, et al. Iliac artery stenting combined with open femoral endarterectomy is as effective as open surgical reconstruction for severe iliac and common femoral occlusive disease. J Vasc Surg. 2011;54(2):402-411.
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