|Year : 2021 | Volume
| Issue : 4 | Page : 310-316
Extra- Anatomical bypass applications still as an alternative in progressive aortoiliac occlusive disease manegement
Ferhat Borulu, Eyup Serhat Calik, Umit Arslan, Yasin Kilic, Izatullah Jalalzai, Bilgehan Erkut, Yahya Unlu
Department of Cardiovascular Surgery, Faculty of Medicine, Ataturk University, Erzurum, Turkey
|Date of Submission||13-Jun-2021|
|Date of Decision||02-Aug-2021|
|Date of Acceptance||16-Aug-2021|
|Date of Web Publication||9-Dec-2021|
Eyup Serhat Calik
Department of Cardiovascular Surgery, Faculty of Medicine, Ataturk University, Erzurum
Source of Support: None, Conflict of Interest: None
Aims: Extra-anatomical bypass (EAB) is still an important alternative treatment method in patients with aortoiliac occlusive disease (AIOD). Settings and Design: In this study, we assessed the results of EAB procedures, over a 22-year period, based on 30-day morbidity and mortality, 1st month, 1st, 3rd, and 5th year patient survival, primary patency, and limb salvage rates. Subjects and Methods: A retrospective review and analyze was performed on a single-center database of consecutive 46 patients who underwent femorofemoral or axillofemoral bypass grafting procedures from 1998 to 2020. All patients were called to followed up and were performed clinical examination and color duplex ultrasound (CDUS) evaluation for determination of graft patency. The surviving patients were followed-up for 5 years. Statistical Analysis Used: Five-year survival, graft patency, and limb salvage rates were calculated by the Kaplan–Meier method. Results: The 46 subjects included 25 (54.3%) femoral and 21 (45.7%) axillary bypass applications. The mean age was 64.2 ± 12.8 years (28–82) and 36 were male (78.3%). Critical limb ischemia was the most accounted indication for EAB surgery (25/54.4%). The cumulative mortality rate was 34.8% at 5 years' period. The graft patency and limb salvage rates for femoral and axillary applications were 59.2% versus 57.4% and 86.4% versus 80% at 5 years, respectively. Conclusions: Femorofemoral and axillofemoral bypasses are suitable for patients with AIOD requiring revascularization for relief of symptoms or limb salvage, who are not candidates for endovascular therapy or who are at high risk for direct anatomical revascularization.
Keywords: Axillofemoral graft, femorofemoral graft, long-term graft patency, long-term limb salvage, long-term survival
|How to cite this article:|
Borulu F, Calik ES, Arslan U, Kilic Y, Jalalzai I, Erkut B, Unlu Y. Extra- Anatomical bypass applications still as an alternative in progressive aortoiliac occlusive disease manegement. Indian J Vasc Endovasc Surg 2021;8:310-6
|How to cite this URL:|
Borulu F, Calik ES, Arslan U, Kilic Y, Jalalzai I, Erkut B, Unlu Y. Extra- Anatomical bypass applications still as an alternative in progressive aortoiliac occlusive disease manegement. Indian J Vasc Endovasc Surg [serial online] 2021 [cited 2022 Sep 24];8:310-6. Available from: https://www.indjvascsurg.org/text.asp?2021/8/4/310/332053
| Introduction|| |
Extra-anatomical bypass (EAB) refers to applications outside the natural anatomical pathway which are well-recognized method of lower extremity revascularization in patients with aortoiliac occlusive disease (AIOD). These procedures have been applied since Freeman and Leeds first described the femorofemoral crossover bypass (FeFCB) in 1952. Blaisdell, Hall, and Louw described axillofemoral bypass in 1963.,
Today, percutaneous angioplasty and stenting are performed at increasing rates for lower limb ischemia due to stenotic arterial disease. However, these interventions are often unsuitable in patients with long chronic occlusions of the aortoiliac segments or sometimes the interventions may result in failure. Therefore, surgical approaches still play an important role, especially for the treatment of AIOD.
The indications of EAB procedures are generally the same with current conventional surgical revascularization: Critical limb ischemia and intermittent claudication which conservative therapy is in failure. However, patients who are scheduled for revascularization due to aortic occlusive disease but are considered to be at high risk for the classical procedure, such as high risk of anesthesia, low cardiac, or respiratory reserve who cannot tolerate the trans-abdominal approach are candidates for EAB. In addition, some patients have local difficulties to perform aortofemoral revascularization related to previous femoral anastomoses or due to the presence of infection in the inguinal region of the previous aortofemoral graft.,,
In this study, we assessed the results of extra-anatomical bypass procedures over a 22-year period based on 30-day morbidity and mortality rates and 1 month, 1, 3-, and 5-year primary patency rates, patient survival, and limb salvage rates.
| Subjects and Methods|| |
A retrospective review and analysis was performed on a single-center database of consecutive patients who underwent femoro-femoral or axillofemoral bypass grafting procedures from 1998 to 2020 at the our institution. The informed consent was obtained from the patients for the surgical applications. However, patient consent and Institutional Ethics Committee Approval for this study were not necessary because of included a retrospective analysis of the recorded hospital data and did not disclose patient identities.
The patients demographic features, presenting symptoms, comorbidities, the surgical procedures, and their postoperative complications data were collected and recorded. Patients who had regular follow-ups were evaluated with clinical, ankle-brachial index (ABI), and color duplex ultrasound (CDUS) examinations, as well as graft patency, inflow and outflow arteries evaluation were done on follow-up visits. The surviving patients were followed up for 5 years or until death.
The patients were assessed in two categories as “femoral application” (FeFCB) or “axillary application” (AxFB) (axillo-unifemoral [AxUFB] or axillo-bifemoral bypass [AxBFB]).
All operations were performed at supine position and under general anesthesia. All patients received a ring reinforced, 8-mm expanded polytetrafluoroethylene (ePTFE) graft.
Bilateral common, superficial, and profunda femoral arteries were explored and suspended. Both ends of the 8 mm PTFE graft, which was passed through the tunnel created in the suprapubic region before heparinization (5000 IU), were end-to-side anastomoted to the appropriate areas on the common femoral arteries by the continuous suturing technique using 5.0 or 6.0 polypropylene sutures.
Infraclavicular incision was made and the axillary artery was explored. The pectoralis muscle was exposed, and fibers were split superiorly and inferiorly. Longitudinal or oblique groin incisions were made, and the common, superficial, and profunda femoral arteries were exposed and controlled. Subcutaneous tunneling which extending from the axillary incision to the femoral incision, lateral to the pectoralis major muscle, on the midaxillary line and above the abdominal fascia, was performed prior to heparinization. If required, a femoral-to-femoral tunnel was formed in the suprapubic region for a bifemoral reconstruction. After intravenous heparinization (5000 IU), a proximal axillary end-to-side anastomosis and femoral distal end-to-side anastomosis were made by continuous suture technique with 8 mm PTFE graft, using 5.0 or 6.0 polypropylene sutures. Femorofemoral bypass was then performed for axillobifemoral procedures. We have been using preconstructed T-shaped axillobifemoral grafts after 2010.
In the early period of postoperative care, continuous or intermittent heparin was given routinely to all patients for the first 2 days. Afterward, low molecular weight heparin was continued until discharge. All patients were started on aspirin 100 mg/day. In recent years, clopidogrel 75 mg/day has been added to the treatment. Warfarin sodium was additionally given as an anticoagulant in patients with poor run-off. Patients were called for follow-up visits at 1st month after discharge and every 6 months thereafter for the evaluation of clinical status, graft patency, and flow of inflow and outflow arteries.
The extremity amputation (transtibial or transfemoral) was accepted as the major result of initial pathology and surgery. Deaths within 30 days after surgery were accepted as operative mortality.
The statistical analyses were performed using the SPSS version 18.0 package software (SPSS, Chicago, IL, USA). Survival, graft patency, and limb salvage rates were calculated by the Kaplan–Meier method. The differences were tested by Mann-Whitney U-test for ordinal variates without normal distribution. Other data were analyzed using Fisher's exact test or Pearson's Chi-squared test. Statistical significance level was adjusted to P < 0.05.
| Results|| |
In the study period, a total of 46 subjects underwent EAB surgery which included 25 (54.3%) FeFCBs and 21 (45.7%) AxFBs for AIOD. The mean age was 64.2 ± 12.8 years (range 28–82) and 36 of patients were male (78.3%). Patients demographic and clinical characteristics were summarized in [Table 1]. The most common risk factors associated with initial disease were hypertension (78.3%), smoking (63%), and coronary artery disease (63%). Most of the patients had two or more comorbidities.
Critical limb ischemia in 25 (54.4%) patients, severe incapacitating claudication in 14 (30.4%), infection at the operative wound of a previous abdominal surgery in 4 (8.7%), and graft occlusion of a previous aortobifemoral bypass due to progression of the disease in 3 (6.5%) were the indications for EAB surgery. Twenty patients (43.5%) underwent urgent EAB surgery in the same session or the following day. These patients underwent urgent thrombectomy due to critical limb ischemia, and angiography was performed during the procedure. The other patients (56.5%) were operated electively. Infrainguinal bypass for lower limb revascularization was performed in 10 patients (21.7%). Most of them were axillary group (6/4). Angioplasty was performed in 6 patients in the femoral group and 4 patients in the axillary group during EAB surgery.
Postoperative morbidity and mortality
Postoperative complications are shown in [Table 2]. A total of 17 (37%) infections, 9 (19.6%) were local wound site infections, and 8 (17.4%) were graft infections. The infected grafts were removed immediately, and revascularization was achieved with another graft by passing intact tissues. Early graft occlusion was observed in 8 (17.4%) patients in total. Thrombectomy was performed in all of eight patients and was successful in seven (4 femoral, 3 axillary). The other one in the axillary group gone to amputation at the same hospitalization. Revision surgery was performed in 4 (8.7%) patients for bleeding or hematoma.
|Table 2: Complications and additional interventions after extra-anatomical bypass surgery|
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Five (10.9%) patients died within 30 days of their operation (3 axillary, 2 femoral). Causes of death were cardiac in 3 patients and septicemia in two. None of the patients died intraoperatively.
Survival, graft patency, and limb salvage
The mean follow-up time was 24.6 months (maximum 88 months). The 5-year survival rate was 48.6% by the Kaplan–Meier survival curves for each application [Figure 1]. The follow-ups were lost for 5 patients in the femoral group and for 5 in the axillary group at the end of the 5-year. The survival rates were found to be significantly less in the axillary group (<0.001). The cumulative mortality rate was 34.8% at 5-year period. The reasons of mortality at 5 years are shown in [Table 3].
|Figure 1: Kaplan-Meier analysis of survival for femoral and axillary applications for 5 years during the study period|
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The graft patency rates for femoral and axillary groups were 100% versus 95.2%, 84.2% versus 80%, 68.4% versus 66.7% and 59.2% versus 57.4% at 1st month, 1st, 3rd, and 5th year, respectively [Figure 2]. The limb salvage rates for femoral and axillary groups were 100% versus 95.2%, 94.7% versus 93.3%, 89.5% versus 86.7% and 86.4% versus 80% at 1st month, 1st, 3rd, and 5th years, respectively [Figure 3]. There was no statistically significant difference between the two applications in terms of graft patency and limb salvage (P = 0.089 vs. P = 0.076). Totally, 7 (15.2%) patients required limb amputations (4 axillary and 3 femoral). Three of them were above-knee amputations and four below-knee.
|Figure 2: Kaplan-Meier analysis of primary patency rate for femoral and axillary applications for 5 years|
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|Figure 3: Kaplan-Meier analysis of limb salvage rate for femoral and axillary applications for 5 years|
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| Discussion|| |
Since femorofemoral crossover and axillofemoral graft bypass were first described as extra-anatomical bypass procedures in 1950s, these operations have been a well-recognized method of lower limb revascularization in patients with AIOD.,, Nowadays, endovascular interventional (EVI) technologies have shown great improvement, and the application of angioplastic methods in the treatment of AIOD is increasing. Parallel to this, the use of EAB techniques has decreased gradually, especially after the mid-1980s.,,, However, these interventional techniques are not suitable for many patients. Particularly, patients with Leriche syndrome, long chronic total occlusions, tortuous, and severe calcified vessels pose great challenges for EVI. In parallel, complications that may occur in this type of difficult interventions and failure of the procedure may frequently experience.
The main purpose of EABs is to simplify a major surgical procedure such a classical anatomical aortofemoral bypass (AoFB), allowing more patients to be revascularized. It requires deliberate avoidance of the natural anatomical route., The most common examples are AxFB and FeFCB and their combination AxBFB. In these procedures, intentional abdominal entry is avoided, the two main reasons for doing this are: (1) avoiding intra-abdominal pathological features such as abdominal infection, problems related to previous abdominal surgery, (2) to avoid the high risk of transabdominal reconstruction in patients with severe comorbidities due to cardiovascular, pulmonary, or other local and systemic comorbidities.,,,, Considering mortality, primary and secondary patency rates, these EAB procedures provide a significant reduction in operative mortality and a good increase in long-term graft patency compared to open abdominal surgery in patient groups that should be deliberately avoided by the natural anatomical pathway.,
Although classical AoFB has high long-term patency rates, it is less preferred in high-risk patients due to its morbidity, mortality, and relatively long hospital stay.,,,, In the past years, graft patency rates of EAB procedures had not been satisfactory; nevertheless, EAB procedures were a well-established alternative to AoFB, especially in patients with graft infection, infected aortic aneurysm, and aortoenteric fistula.,,, The promising results that have recently emerged with EAB procedures should be considered evidence of its success in AIOD therapy.,, Passman et al. compared AoFB and AxFB in the treatment of AIOD and reported 5-year patency rates as 80% for AoFB and 74% for AxFB in their study which is one of the first prospective studies on this subject. They demonstrated that the patency and limb salvage outcomes of AxFB to be equivalent to AoFB when reserved for high-risk patients with limited life expectancy. Similar results were reported by Onohara et al. in a multivariate analysis of long-term results of AxFB and AoFB. In a recently published comparative study by Igari et al. reported that limb salvage rates equivalent, although AxFB patency rates inferior than those with AoFB. Therefore, they recommend that AxFB as an alternative treatment method for AIOD, especially when limb salvage is a goal.
Five-year primary and secondary FeFCB patency rates in EAB procedures were generally higher than AxBFB or AxUFB procedures in past studies., Sir Blaisdell in a “Hıstorıcal Vignette” article published in 2011, reported that the 5-year long-term patency rate for femorofemoral grafts was excellent with an average of 75%. In a literature review conducted in 1995; in the experience of 27 authors from 1971 to 1994, the 5-year patency rate for AxBFB grafts ranged from 30% to 85%., In our study, 5-year patency rates in femoral applications were similar to axillary applications (59.2% vs. 57.4%). Limb salvage rates were better in femoral applications (89.5% vs. 80%), but there was no significant difference. Ricco et al. in their a multicenter randomized study comparing FeFCB with direct anatomical bypass in patients with isolated unilateral iliac occlusive disease, not amenable to angioplasty, showed that; late patency was higher after direct bypass than crossover bypass in good-risk patients (92.7% vs. 73.2% P = .001). They recommended that crossover bypass should be reserved for high-risk patients with unilateral iliac occlusion not amenable to percutaneous revascularization.
Samson et al. evaluated their series of 161 patients with AIOD which were administered AxFB (85 AxBFB, 76 AxUFB) between 1991 and 2016 and they reported that their series had one of the highest 5-year primary patency rates (83.7%) ever reported for this procedure. In the study, 5-year patency rates after AxUFB and AxBFB were reported as high as 85.5% and 81.8%, respectively. They suggested that AxFB can be done successfully with lower morbidity and mortality rates using modern protocols and technology. That is why, AxFB may be offered as primary intervention for patients who have higher risk for direct aortic procedures. In a recent multicenter study, suprainguinal bypass procedures were compared by Saadeddin et al. They reported that FeFCB can be performed with comparable patency rates to AFB and had low mortality and morbidity rates. In the same study, AxFB was associated with the worst outcomes. They suggested that FeFCB may serve as the EAB operation of choice in high-risk patients with extensive disease, who cannot undergo AFB, provided that anatomy permits. AFB should be performed preferentially in low-risk patients with appropriate anatomy. Owing to its higher complications rates, the study suggests that AxFB should be limited to patients with no other option for revascularization. The successful results and improved patency rates in recent years have been a guarantee that the important role of these EABs will continue in today's endovascular era.,,,,,,,,,
On the other hand, in the treatment of AIOD, improved results have been reported with endovascular methods in recent years.,,,,,,,,,,,,, These improved results are parallel to the use of new techniques for EVI and advances in stent-graft technology. With the development of techniques such as Chimney Graft, unibody bifurcated endograft, covered endovascular reconstruction of the aortic bifurcation and kissing stent, endovascular methods have become comparable to AFB in AIOD treatment.,,,, Groot Jebbink et al. presented a systematic review which analyzed 1390 patients with AIOD from 21 studies. TASC (TransAtlantic Inter-Society Consensus) C or D class lesions were found in 48% of these patients who had kissing stenting. The technical success rate was 98.7%, and the complication rate was 10.8%. The primary patency rate at 12, 24, and 60 months was 89.3%, 78.6%, and 69.0%, respectively. In the meta-analysis published by Groot Jebbink et al. based on individual participant data from 5 studies, they presented the data of 605 patients who were endovascular treatment for AIOD between 1995 and 2014. 47% of lesions were in TASC C or D classes. The ABI measurements improved from baseline median 0.73 to median 0.99 at discharge, and the 30-day complication rate was 8.2%. The overall primary patency rate estimate was 81% at 2 years. In a current meta-analysis published by Premaratne et al., the comparison of direct surgical (DS) and EVI was analyzed. Out of 11 observational studies, 4030 patients, 1679 of them underwent DS and 2351 EVI/hybrid revascularization for AIOD from 2000 to 2018. TASC C and D lesion averages were similar between the groups, but the mean age was significantly lower in the DS group. The mean length of hospitalization was significantly higher for DS patients. Change in ABI, 30-day mortality, and 30-day graft/stent thrombosis was similar for the groups. Overall, primary patency for a median follow-up of 50 months favored the DS group. Similarly, a recent study published by Mayor et al. comparing EVI and DS in AIOD had primary patency rates in favor of DS. However, several recent studies reported similar patency rates between DS and EVI.,, Quan et al. reported higher patency rates in favor of EVI. On the other hand, EVIs provide low complication rates and short hospital stay, but they require more additional interventions.,,,,
Although the trend of the endovascular approach is gradually increasing, it has some disadvantages. Stent placement in a highly calcified or highly tortuous artery may be difficult or impossible. It is sometimes impossible to pass a chronic total occluded lesion.,,,, In such difficult cases, interventional complications such as arterial perforation, dissection, or perioperative stent thrombosis can often occur., In such cases, EABs are also an alternative to EVI methods in patients with high risk for open surgery.,
We think that vascular surgeons should increase their EVI skills as much as possible without losing their open surgical abilities. The success of long-term results of AFB in patients with low surgical risk still makes this method attractive. EVIs may be favorite treatment methods in patients with advanced age, high surgical risk or low life expectancy due to their low complication rates, short hospital stay, and less invasive nature. On the other hand, EABs are continue to be up-to-date as an alternative to both methods.,,
Modifiable risk factors for atherosclerotic vascular diseases have been generally well defined and include smoking, DM, hypertension, hypercholesterolemia, and air pollution. Risk factors for peripheral arterial disease (PAD) that we identified in our small cohort were hypertension, smoking, hypercholesterolemia, and DM. In addition, we identified a high rate of chronic obstructive pulmonary disease (COPD). Although COPD is not considered a direct risk factor for PAD, we think that it can be considered as an indirect risk factor because it is related to smoking, air pollution, and many harmful inhaledchemicals.
Many factors affect graft patency. Such as progression of disease in inflow and outflow arteries, type of graft materials, configuration or quality, developments in antiplatelet, statin and vasodilator drugs, patient compliance, regulation of living conditions or reduction of risk factors, improvements in imaging methods. As well as increase in surgeon's skill and experience, and improvements in anesthesia management.,,,,, Its reported that there was no significant difference between grafts produced from Dacron or PTFE in studies, examining the effects of graft features on graft patency in EABs.,, However, externally supported grafts such as ring-reinforced ePTFE grafts have been found to have higher patency rates than unsupported grafts.,,, We used ring-reinforced ePTFE grafts in our EAB procedures.
Our study has several limitations. The retrospective design of the study, the small size of the subjects cohort, and follow-up loss of 10 patients are major limitations. Due to the nature of the retrospective study, we did not have data that we could obtain with prospective planning. Thereby, the patient data that we could obtain mostly from the hospital registry system and the National database had an inadequate or error potential. Although we used ePTFE grafts, we did not have a standard graft protocol in this regard, and the fact that the product of the same company was not used in the whole study period made it difficult for us to determine the effect of graft properties on graft patency. In addition, we did not have enough data to evaluate the effects of inflow and outflow arteries on the graft patency for all of subject.
| Conclusions|| |
Femorofemoral and axillofemoral bypasses are suitable for patients with AIOD requiring revascularization for relief of symptoms or for limb salvage, who are not candidates for endovascular therapy and are at high risk for direct anatomical revascularization. Patients with high risk for AFB whom would be considered poor candidates for EVI due to the TASC II type C or D lesions or had failed prior EVIs should be served EAB surgery. As a conclusion, EAB surgery for AIOD keeps on to be an important alternative treatment method for both AFB and EVI.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2], [Figure 3]
[Table 1], [Table 2], [Table 3]