| | Long-term results of a multicenter randomized study on direct versus crossover bypass for unilateral iliac artery occlusive diseasePresented at the 2007 Vascular Annual Meeting, Baltimore, Md, Jun 6-10, 2007. Received 31 May 2007; accepted 21 August 2007. published online 09 November 2007. ObjectiveTo compare late patency after direct and crossover bypass in good-risk patients with unilateral iliac occlusive disease not amenable to angioplasty. MethodsBetween May 1986 and March 1991, 143 patients with unilateral iliac artery occlusive disease and disabling claudication were randomized into two surgical treatment groups, ie, crossover bypass (n = 74) or direct bypass (n = 69). The size of the patient population was calculated to allow detection of a possible 20% difference in patency in favor of direct bypass with a one-sided alpha risk of 0.05 and a beta risk of 0.10. Patients underwent yearly follow-up examinations using color flow duplex scanning with ankle-brachial systolic pressure index measurement. Digital angiography was performed if hemodynamic abnormalities were noted. Median follow-up was 7.4 years. Primary endpoints were primary patency and assisted primary patency estimated by the Kaplan-Meier method with 95% confidence interval. Secondary endpoints were secondary patency and postoperative mortality and morbidity. ResultsCardiovascular risk factors, preoperative symptoms, iliac lesions TASC class (C in 87 [61%] patients and D in 56 [39%] patients), and superficial femoral artery (SFA) run-off were comparable in the two treatment groups. One patient in the direct bypass group died postoperatively. Primary patency at 5 years was higher in the direct bypass group than in the crossover bypass group (92.7 ± 6.1% vs 73.2 ± 10%, P = .001). Assisted primary patency and secondary patency at 5 years were also higher after direct bypass than crossover bypass (92.7 ± 6.1% vs 84.3 ± 8.5%, P = .04 and 97.0 ± 3.0% vs 89.8 ± 7.1%, P = .03, respectively). Patency at 5 years after crossover bypass was significantly higher in patients presenting no or low-grade SFA stenosis than in patients presenting high-grade (≥50%) stenosis or occlusion of the SFA (74.0 ± 12% vs 62.5 ± 19%, P = .04). In both treatment groups, patency was comparable using polytetrafluoroethylene (PTFE) and polyester grafts. Overall survival was 59.5 ± 12% at 10 years. ConclusionThis study showed that late patency was higher after direct bypass than crossover bypass in good-risk patients with unilateral iliac occlusive disease not amenable to angioplasty. Crossover bypass should be reserved for high-risk patients with unilateral iliac occlusion not amenable to percutaneous recanalization. Crossover femorofemoral bypass described by Freeman and Leeds1 in 1952 was first used as an alternative to direct aortofemoral bypass in high-risk patients with critical ischemia due to unilateral iliac artery occlusive disease.2 Having since gained broad acceptance, crossover bypass is now widely used to treat complex vascular problems associated with failed aortofemoral bypass or unilateral long-segment iliac occlusion graded TASC-C or –D.3 Unilateral iliac artery stenosis graded TASC-A or -B is now treated by angioplasty. Outcome of crossover bypass has varied widely in published series. The most likely explanation for this variability involves patient selection. Some authors use crossover bypass exclusively for high-risk patients with limb threatening ischemia while others extend indications to low-risk patients with claudication. Investigators using extended selection criteria have reported optimal outcomes with 5-year patency rates ranging from 82% to 90%.4, 5, 6 Variation in outcome has led to confusion regarding the utility of crossover bypass in comparison to direct bypass and the impact on late patency of variables such as the donor iliac artery disease,7 femoral artery run-off, and type of graft material.8, 9, 10 To gain more insight into these issues, the French University Surgeons Association (French acronym, AURC) undertook a multicenter randomized trial11 to compare the patency and safety of crossover bypass and direct bypass in good-risk patients with symptomatic unilateral iliac occlusive disease not amenable to endovascular treatment. The purpose of this report is to describe long-term follow-up results of that trial. Patients and methods  This prospective multicenter trial comparing direct and crossover bypasses was conducted from May 1986 to March 1991 at 20 hospitals in France (see list in Appendix, online only). The study design was approved by the ethics committee of the University Hospital of Poitiers, and all patients provided written informed consent. Random assignment of patients to the two treatment groups was done independently of participating centers in a one-to-one ratio. The randomization sequence was generated by a computer program and supplied to centers using sealed opaque envelopes generated in blocks of five. Endpoints Primary endpoints were primary patency and assisted primary patency. Secondary endpoints were secondary patency and postoperative morbidity and mortality. This study used a strict definition for primary patency12 that included persistent patency without repeat intervention not only on the bypass and its anastomoses but also on the donor iliac artery of crossover bypasses. Assisted primary patency was defined as patency achieved with minor reintervention including dilation or anastomotic revision to prevent graft failure. Secondary patency was defined as patency obtained by restoration after occlusion. In this study, choice of prosthetic graft with regard to material, external support, and diameter was not randomized and left to the discretion of the surgeon. Patient selection criteria Patients were eligible for inclusion if they had (1) unilateral disabling intermittent claudication with a walking distance of less than 300 meters and significantly reduced ankle-to-brachial systolic blood pressure index (ABI) ≤0.6 and (2) occlusion or diffuse stenosis involving the common iliac artery, external iliac artery, and/or common femoral artery considered by the surgeon as not amenable to percutaneous angioplasty or recanalization (Table I). An additional criterion for inclusion was demonstration of normal contralateral common and external iliac arteries on anteroposterior and oblique angiographic views with normal duplex scan findings including a peak systolic velocity <1.2 m/s in the common and external iliac arteries. Patients over the age of 75 years, presenting comorbid conditions that impaired short-term survival or requiring hemodialysis were excluded. Patients with general risk factors for laparotomy including resting angina, recent myocardial infarction, severe obesity with a body-mass-index ≥35, or respiratory insufficiency defined as hypoxia <75 mm Hg, hypercapnia >50 mm Hg at rest, and one-second forced expiratory volume less than 50% of the calculated value were also excluded. Finally, patients with a history of aortofemoral or femorofemoral bypass, major abdominal wound hernia, more than two laparotomies, or pelvic radiation therapy were excluded. Immediate postoperative assessment Bypass patency was assessed by color flow duplex scan. Respiratory complications were defined as either occurrence of pulmonary infection or need for respiratory support longer than 24 hours. Ischemic cardiac complications were defined as the presence of electrocardiogram (ECG) abnormalities. Groin incisions were regularly checked to detect healing complications including lymphocele, lymphorrea, and superficial or deep infection. Duration of hospitalization was recorded. Late follow-up assessment Follow-up examinations were carried out at 1 month and yearly thereafter. Outpatient visits included clinical examination with measurement of walking distance and Doppler study with determination of ABI. Angiography was performed if hemodynamic deterioration was found, ie, 15% decrease between two successive ABI measurements or if duplex scanning peak systolic velocity in the graft or in the donor iliac artery was greater than 2.5 m/s. The median duration of follow-up was 7.4 years with 112 (78%), 82 (57%), and 20 (14%) patients being followed up 5, 7, and 10 years, respectively. Statistical analysis A meta-analysis of published crossover bypass series13, 14, 15, 16 was performed to determine the size of the study population necessary to show a possible difference in the 3-year primary patency of 20% with a one-sided alpha of 0.05 and beta risk of 0.10. Findings demonstrated that the mean actuarial 3-year primary patency for crossover bypasses was 67%. Accordingly, it was calculated that the number of patients needed to show a 3-year patency of 87%, in favor of the direct bypass, was 70 per group. Proportions, means and medians were compared using the Fisher exact test or the Wilcoxon nonparametric test as appropriate. Primary and secondary patency rates were calculated using the Kaplan-Meier method with 95% confidence interval (95% CI).17 Groups were compared using the log-rank test with calculation of the hazard ratio with 95% CI. Results Between May 1986 and March 1991, 147 patients presenting unilateral iliac artery stenosis or occlusion were randomized into the two treatment groups (Fig 1). The two study groups (Table I) were comparable with regard to vascular risk factors, preoperative symptoms, iliac artery lesions, and superficial femoral artery (SFA) run-off. Surgical techniques Direct revascularization consisted of unilateral aortofemoral bypass in 36 cases and common iliac to femoral bypass in 33. These procedures were performed through a transperitoneal approach in 26 cases and a retroperitoneal approach in 43. Distal implantation was performed on either the common femoral artery (n = 45) or deep femoral artery (n = 24) depending on the extent of the femoral lesions. Five patients underwent femoropopliteal or femorotibial bypass during the same procedure. Crossover revascularization consisted of femorofemoral bypass in 41 cases including 28 in which the graft was routed subcutaneously and 13 in which the graft was routed through the Retzius space. In the remaining 33 patients, crossover bypass consisted of iliofemoral bypass with exposure of the external iliac artery via a supra-inguinal route and graft placement in the Retzius space. Distal implantation was performed on the common femoral artery in 46 cases and on the deep femoral artery in 28. Nine patients underwent femoropopliteal or femorotibial bypasses during the same procedure. In the direct bypass group, the graft material was polytetrafluoroethylene (PTFE) in 29 cases and polyester in 40. In the crossover bypass group, the graft material was PTFE in 53 cases and polyester in 21. Externally supported grafts were used for crossover bypass in 30 cases. Graft diameter was 8 mm in 102 cases, 7 mm in 35, and 6 mm in 6. Prophylactic antibiotics and intravenous heparin therapy (0.5 mg/kg) were routinely used before clamping in both groups. Postoperative complications As shown in Table II, general complications were more frequent after direct bypass (7.1%) than crossover bypass (2.6%) but the difference was not significant (P = .26, relative risk: 0.54 with 95% CI: 0.16 to 1.76). One patient in the direct bypass group died due to myocardial infarction within the first 30 postoperative days. Healing complications in the groin including one graft infection were more frequent after crossover bypass (13.4%) than direct bypass (4.3%) but this difference was not significant (P = .08 relative risk: 0.32 with 95% CI: 0.09 to 1.12). Duration of hospitalization was significantly shorter in the crossover bypass group than in the direct bypass group. Sexual function was analyzed in 59 patients who underwent direct bypass and in 67 patients who underwent crossover bypass. Preoperative erectile dysfunction was reported by five patients (8.5%) in the direct bypass group and six patients (8.9%) in the crossover bypass group. At 6 months postoperatively, erectile dysfunction was reported by two patients (3.4%) in the direct group and three patients (4.5%) in the crossover bypass group. In addition, four patients (6.8%) in the direct group reported postoperative ejaculatory disorder (Table II). Primary patency Primary patency rates at 5 and 10 years were 71.8% and 55.6%, respectively in the crossover bypass group compared with 92.7% and 82.9%, respectively in the direct bypass group (Fig 2). These differences were significant (P = .001, hazard ratio: 4.1 with 95% CI: 1.8 to 6.7). The 30 primary graft failures in the crossover bypass group were due to occlusion of the crossover bypass in 14 cases, stenosis of the femoral anastomosis in four, and stenosis of the donor iliac artery in 12. The eight primary graft failures in the direct bypass group were due to graft occlusion in six cases and stenosis of the femoral anastomosis in two. In the direct bypass group, 14 patients (20.2%) developed significant stenosis of the contralateral iliac artery requiring angioplasty in six and crossover bypass in two. These procedures did not affect patency of the direct bypass. Assisted primary patency and secondary patency Assisted primary patency rates at five and 10 years were 84.3% and 74.8%, respectively in the crossover bypass group compared with 92.7% and 86.1%, respectively in the direct bypass group (Fig 3). These differences were significant (P = .04, hazard ratio: 2.5 with 95% CI: 1.1 to 5.8). Secondary patency rates at five and 10 years were 89.8% and 82.9%, respectively in the crossover bypass group vs 97.0% and 94.9%, respectively in the direct bypass group (Fig 4). These differences were significant (P = .03, hazard ratio: 3.7 with 95% CI: 1.1 to 9.8). As shown in Fig 5, all primary crossover bypass graft failures (n = 30) required further revascularization. In 30 cases of primary crossover bypass failure, flow was successfully maintained or restored by patch placement on the femoral anastomosis in four of four cases, angioplasty of the donor iliac artery in 10 of 12, and thrombectomy of the crossover graft in six of 14. In five of the eight primary direct bypass failures, patency was successfully restored or maintained by femoral patch angioplasty in two of two and by thrombectomy in three of six. Two patients, one in each group (n = 2), required major lower limb amputation. Impact of femoral artery run-off on bypass patency Patency after crossover and direct bypass was analyzed in function of SFA run-off in the recipient leg. In the crossover bypass group, primary patency rates at five and 10 years were 71.9% and 64.3%, respectively in patients presenting no or low-grade (<50%) stenosis of the SFA compared with 62.5% and 42.3%, respectively in patients presenting high-grade stenosis (≥50) or occlusion of the SFA (Fig 6). This difference was significant (P = .04, hazard ratio: 2.0 with 95% CI: 1.04 to 5.0). In the direct bypass group, primary patency rates were not significantly correlated with SFA run-off with a 10-year patency rate of 95.8% in patients presenting no or low-grade (<50%) stenosis of the SFA compared with 90.4% in patients presenting high-grade stenosis (≥50) or occlusion of the SFA (P = .94, hazard ratio: 0.98 with 95% CI: 0.2 to 5.8). In this analysis, SFA run-off was considered as normal in patients who underwent concomitant infrainguinal revascularization. Impact of technique and prosthetic material In the crossover bypass group, primary patency at 5 years was not significantly different for polyester and PTFE grafts: 76.2% vs 65.6%, respectively (P = .24, hazard ratio: 0.61 with 95% CI: 0.29 to 1.37). Similarly in the direct bypass group, patency at 5 years was comparable for polyester and PTFE grafts: 95.0% vs 89.4% (P = .98, hazard ratio: 0.98 with 95% CI: 0.22 to 4.4). Primary patency was not significantly different between aortofemoral direct bypass and common-iliac-to-femoral direct bypass or between femorofemoral crossover bypass and external iliac-to-femoral crossover bypass. Finally, no significant difference in patency was observed within each group according to the graft diameter and patency was comparable for externally supported grafts and unsupported grafts in the crossover group. Hemodynamic outcome on the symptomatic side after direct and crossover bypass To evaluate hemodynamic outcome, ABI was measured in the symptomatic leg before and after revascularization. As shown in Table III, preoperative and postoperative ABI was comparable in the two treatment groups, thus, suggesting that the hemodynamic outcome of direct and crossover bypass was comparable. Hemodynamic assessment on the donor artery side after crossover bypass To study the possible hemodynamic consequences of crossover bypasses on flow in the donor iliac artery used as the take-off vessel, ABI was measured on the donor side before and after crossover bypass in function of the SFA run-off. As shown in Table IV, no significant difference was found between preoperative and postoperative ABI on the donor side. Survival Patient survival was 94.8% at 5 years and 59.5% at 10 years. Thirty-three patients died during follow-up. The main causes of death were cardiovascular disease (n = 18) and cancer (n = 6). There was no significant difference in survival between the direct and crossover bypass groups (P = .58, hazard ratio: 1.2 with 95% CI: 0.6 to 2.4). Discussion This randomized study shows that primary patency, assisted primary patency, and secondary patency were significantly better after direct bypass than after crossover bypass. Since progression of atherosclerosis in the donor artery is a frequent cause of crossover bypass failure, this study used a strict definition for the end of primary patency12 that included not only development of significant stenosis in the crossover bypass graft itself but also in the contralateral donor iliac artery. The risk of disease progression in the contralateral donor iliac artery was the main criteria used by Piotrowski et al18 to indicate aortofemoral bypass instead of crossover bypass even in young patients. After a median follow-up of 7.4 years in our study in which presence of a normal contralateral iliac donor artery was a condition for inclusion, stenosis in the artery that served or would have served as the donor artery for crossover bypass, was observed in 12 patients (16.2%) randomized for crossover bypass and in 14 patients (20.2%) randomized for direct bypass. The high potential for development of significant atherosclerotic disease in previously healthy iliac arteries underlines the need for surveillance using color flow duplex imaging. In the 12 patients with crossover bypasses, color flow duplex surveillance allowed detection of stenosis and restoration of patency by iliac angioplasty. Determination of the status of the donor iliac artery is thus a key element for successful crossover bypass. However, assessment is difficult. Many authors consider angiography alone as unreliable.19, 20 Archie et al19 stated that direct measurement of femoral artery pressure at rest and after injection of papaverine lacked sufficient sensitivity and specificity for preoperative decision-making. In our study, normal aspect of the potential donor iliac artery on both angiography and duplex scan was a prerequisite for inclusion. Although this criterion is arguably overly restrictive, our intention was to eliminate preoperative status of the donor iliac artery as a confounding factor for comparison of direct and crossover bypass. The requirement for a normal contralateral iliac artery was the main reason that it took 5 years to randomize 143 patients in the 20 surgical centers participating in this study. Indeed many patients with extensive unilateral iliac lesions have some form of contralateral iliac disease. As early as 1973, Porter et al21 acknowledged the frequency of some degree of contralateral iliac disease in patients with extensive unilateral iliac disease and became one of the first groups to recommend use of donor iliac angioplasty in combination with crossover bypass. Not surprisingly use of endovascular techniques that can provide excellent long-term results in selected iliac artery lesions has improved the outcome of crossover bypass in patients with a suboptimal donor iliac artery.22, 23, 24 The experience of several authors25, 26, 27 has supported this view. In nonrandomized studies comparing crossover femoral grafts with or without donor iliac balloon angioplasty, both Schneider et al25 and Perler et al24 concluded that patency of the crossover bypass in patients who underwent preliminary stenting of the iliac artery was comparable to that of patients whose donor iliac artery was normal. These findings clearly support the use of angioplasty with or without stenting before or at the same time as crossover bypass in eligible patients with donor iliac lesions. Recently, AbuRahma et al28 reported that successful crossover bypass after angioplasty was more likely if the dilated iliac lesion was short and located in the common iliac artery. Another reported cause of crossover femorofemoral graft failure is progression of outflow arterial disease in the recipient limb.4, 29, 30 In our study, occlusion or significant stenosis of the SFA in the recipient leg was associated with significantly lower patency after crossover bypass but not after direct bypass. However, the clinical value of this finding is subject to caution because the impact of SFA status on bypass patency was not a primary endpoint of the study, and also because of the small size of these subgroups. Another concern expressed by many investigators about crossover bypass involves the ability of one iliac artery to supply blood flow to both legs and the possibility of hemodynamic steal from the donor limb. Using an experimental model, Ehrenfeld31 was the first to demonstrate that the flow in the donor iliac artery increased after crossover bypass with no reduction in downstream iliac flow. Sumner and Strandness32 showed that crossover bypass had no significant deleterious effect on the donor limb and that the recipient limb was well perfused provided that there was no hemodynamically significant lesion in the donor iliac artery. Our follow-up findings are consistent with these studies since the only significant ABI reduction observed in the donor limb after crossover bypass involved the 12 patients who developed stenosis of the donor iliac artery. Measurement of ABI also enabled us to compare resting hemodynamics after crossover and direct bypass. This comparison indicated that the hemodynamic results of the two procedures were comparable. Literature data on this point have been contradictory. The Veterans Affairs Cooperative Study No 1419 including 340 patients with crossover femorofemoral grafts showed significant improvement in postoperative ABI. Conversely, based on a nonrandomized study comparing direct and crossover bypasses, Schneider et al25 concluded that resting recipient limb pressure in patients with crossover bypass was abnormal even if femoral outflow was strictly normal. Further study using exercise testing will be needed to settle this issue. Our results also provide some insight into the impact of graft material and external support on long-term results of direct and crossover bypass. Polyester and PTFE grafts performed equally well in both treatment groups. Though this finding is subject to bias since choice of type and diameter of the prosthetic graft was left to the discretion of the surgeon, it is consistent with two randomized studies showing no difference in patency outcome using different graft material for femorofemoral crossover bypass.8, 9 Bypass-related complications including graft infection and seroma formation were also comparable for the two materials. Like Johnson et al,9 we could not confirm the findings of one nonrandomized retrospective study33 showing that externally supported grafts provided better results than unsupported grafts for femorofemoral crossover bypass. The use of different techniques of bypass in the two patient groups in this study could have had a confounding effect on the findings of our analysis although it should be noted that comparable patency was achieved using the two crossover bypass techniques, ie, from the external iliac artery or common femoral artery. Similarly no difference in patency was observed between direct bypass from the aorta and from the common iliac artery. Based on these observations, we do not think that the nonhomogeneity of the groups with regard to surgical techniques had a biasing effect in our study. Regarding graft diameter, our results were concordant with those of Schneider et al25 since there was no significant difference in patency using 6-, 7-, and 8-mm-diameter grafts. However, these subgroups were small and, thus, subject to type 2 error. This study also confirmed the low general morbidity of crossover bypass. This finding appears logical since superficial crossover bypass is less invasive than direct aorto- or iliofemoral bypass even when performed by a retroperitoneal approach. The absence of a significant difference in morbidity between the crossover (2.6%) and direct (7.1%) bypass group in our study is undoubtedly due to our selection criteria that excluded high-risk patients and to our relatively small patient population. Local complications were more frequent in patients undergoing crossover bypass. This difference was probably due to the fact that 41 of the 74 crossover bypasses were femorofemoral procedures requiring bilateral access to the common femoral arteries thus doubling the risk of complications in the groin area. The results of crossover bypass in this study were concordant with those reported in the literature. Table V summarizes the results of recent crossover bypass series that presented 5-year follow-up results using the actuarial or Kaplan-Meier method. Our long-term follow-up data were comparable to those reported by Brener et al29 and Criado et al.26 The good results of unilateral aortofemoral or iliofemoral direct bypass in our study are also in line with those reported by Couch et al44 and Kalman et al.45 Objective review of data from our study and the literature indicates that direct iliac revascularization offers the best long-term patency in patients with extensive unilateral iliac artery occlusion, but currently with the development of endovascular technology, this is likely done by interventional techniques. Author contributions Conception and design: JBR Analysis and interpretation: JBR, HP Data collection: JBR, HP Writing the article: JBR, HP Critical revision of the article: JBR Final approval of the article: JBR, HP Statistical analysis: JBR Obtained funding: JBR Overall responsibility: JBR, HP Appendix. Participating centers University Hospital, Poitiers (J.B. Ricco), University Hospital Charles Nicolle, Rouen (J. Testart, J. Watelet), University Hospital Saint-Eloi, Montpellier (H. Mary), Hôpital Saint-Philibert, Lomme (P. Puppinck), University Hospital, Caen (D. Maiza), Hôpital Pasteur, Langon (P. Plagnol), University Hospital Edouard Herriot, Lyon (J.M. Chevalier), University Hospital Sainte-Marguerite, Marseille (P. Piquet), Clinique Poirier, Chambery (B. Habozit), University Hospital Pitié Salpêtrière, Paris (E. Kieffer, F. Koskas), Hôpital Saint-Michel, Paris (P. Lagneau), University Hospital Henri Mondor, Créteil (J.P. Becquemin), University Hospital du Bocage, Dijon (M. David, R. Brenot), American Hospital, Neuilly (F. Bacourt), University Hospital, Besancon (G. Camelot, J. Combe), University Hospital, Nancy (G. Fieve), University Hospital, Rennes (Y. Kerdiles), Clinique Bizet, Paris (J.M. Fichelle), University Hospital Laennec, Nantes (P. Patra), University Hospital de la Timone, Marseille (A. Branchereau). References 1. 1Freeman NE, Leeds FH. Operations on large arteries: application of recent advances. Calif Med. 1952;77:229–233. MEDLINE 2. 2Vetto RM. The femorofemoral shunt: an appraisal. Am J Surg. 1966;112:162–165. MEDLINE |
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a Vascular Surgery Service, University Hospital of Poitiers, Poitiers, France b Thoracic and Vascular Department, University Hospital, CHUV, Lausanne, Switzerland.  Correspondence: Jean-Baptiste Ricco, MD, PhD, Vascular Surgery Service, University Hospital of Poitiers, Avenue Jacques Coeur, 86021, Poitiers, France.
Competition of interest: none. PII: S0741-5214(07)01420-6 doi:10.1016/j.jvs.2007.08.050 © 2008 The Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved. | |
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