Extra-anatomic bypass procedures for severe aortoiliac occlusive disease

Abstract

Objectives

Extra-anatomic bypass (ExAB) grafting has been questioned due its inferior durability compared to anatomic bypass for aortoiliac occlusive disease (AIOD). This study aims to present early and late outcomes of patients treated with ExAB as well as to evaluate potential prognostic factors.

Methods

This is a retrospective cohort study presenting a series of patients treated with ExAB for AIOD. All patients were treated between 2005 and 2022 within the Vascular Surgery Unit of a University Surgery Clinic. Both early (30-day) and late outcomes were evaluated. Univariate and multivariate analyses were conducted for potential predictors. Kaplan–Meier curve was produced for long-term patency.

Results

A total of 41 patients were treated (85.3% males; mean age: 76.3 ± 4.2 years). Indication for treatment included severe claudication or critical limb ischemia (Rutherford stages III–VI). The following procedures were recorded: Femorofemoral bypass (FFB; n = 21) and axillofemoral bypass (AxFB; n = 20). All procedures were conducted using synthetic grafts with external rings. Early outcomes included no death, no myocardial infarction, no major bleeding, no graft infection, and no major amputation. Regarding late outcomes, 14.6% patients were lost after the first month. For the rest of patients (n = 35), five-year primary patency was 88.6%, primary-assisted patency was 94.3%, and secondary patency was also 94.3%. Limb salvage was 100% within follow-up. Endarterectomy at the distal anastomosis was the only independent predictor associated with worse patency in the long-term (OR = 5.356; 95% CI (1.012–185.562); p = .041).

Conclusions

FFB and AxFB is a safe and durable strategy for treating patients with severe AIOD where no other option is feasible. Regarding predictors, only endarterectomy at the distal anastomosis site was associated with an increased risk for graft failure.

Keywords

Peripheral artery disease extra-anatomic bypass aortoiliac occlusive disease

Introduction

Extra-anatomic bypass (ExAB) grafting has been utilized for over 50 years to treat patients with aortoiliac occlusive disease (AIOD) and chronic limb ischemia (CLI). Traditionally, this strategy has been selected as an alternative when an endovascular or anatomic open procedure is not feasible. The most frequent indications include the existence of severe comorbidities that preclude a high-risk procedure or the presence of a hostile abdomen that precludes a laparotomy.¹ They can be used also as a bailout technique when endovascular repair fails.² The most common extra-anatomic procedures include the axillo-femoral (AxFB) and femorofemoral (FFB) bypass grafting.³ These procedures could also be offered in combination with endovascular techniques to perform hybrid procedures for more complex or bilateral occlusive disease.¹

According to the literature, ExAB procedures offer inferior long-term outcomes, included patency, in comparison to anatomic open procedures.^4,5 Therefore, many have questioned this type of procedures and have abandoned them in a large degree. Additionally, many authors have tried to evaluate potential predicting factors that could affect the durability of ExAB. The aim of the present study is to report early and late outcomes of patients treated with ExaB performed in a tertiary university hospital and to evaluate any risk factors for long-term failure of these grafts.

Methods

This is a retrospective study from a single institution evaluating early and late outcomes among patients treated with ExAB grafting for significant lower extremity ischemia. All cases were treated during the period 2005–2022 within the Vascular Surgery Unit of a University Surgery Clinic. All patients were treated according to the Declaration of Helsinki. No special approval was required by the Institutional Review Board of our institution.

Indication for ExAB in our institution included either severe intermittent claudication (Rutherford stage III) or critical limb ischemia (Rutherford stages IV–VI) due to extended AIOD. All patients were not eligible for other first-line treatments such as anatomic open surgery or endovascular repair. Patients undergoing an ExAB as an adjunct to aorto-uni-iliac endograft placement for aortic aneurysm were excluded. Patients undergoing an emergency bypass procedure, for example, due to acute thrombosis or trauma were also excluded.

The following data were reported: gender, mean age, comorbidities, indication for ExAB, type of ExAB (location of proximal and distal anastomosis), technical characteristics of the procedure (type of material, external support), and antithrombotic treatment. Coral reef aortic/iliac wall was defined as extensive, rock-hard calcifications covering the aortic/iliac wall.

Early (30-day) and late outcomes were analyzed. Early outcomes included mortality, stroke, myocardial infarction, graft thrombosis, major bleeding, graft infection, wound complications, and major/minor amputation. Major amputation was defined as amputation at the level of the femur or at the level of the tibia. Minor amputation was defined as amputation at the level of the toes or the metatarsals. Wound complications included hematoma, lymphorrhea, skin infection, and healing delay. Major bleeding was defined as bleeding necessitating revision or blood transfusion with more than two units. Late outcomes included total survival, graft-related mortality, graft occlusion, major/minor amputations, primary patency, primary-assisted patency, and secondary patency.

The standard follow-up in our department includes a patient’s visit, clinical and ultrasonographic examination after 1, 3, and 6 months, and every year thereafter.

Statistical analysis was conducted using the StatsDirect Statistical software (Version 2.8.0, StatsDirect Ltd, Cambridge, UK). Univariate and multivariate analyses were conducted to assess potential prognostic factors. Odds ratios (ORs) were used to determine effect size, along with 95% confidence intervals (CIs). Kaplan–Meier curves were produced for survival from graft failure.

Results

From 2005 to 2022, a total of 41 patients with severe lower limb ischemia were treated with an ExAB in our institution. In total, 85.3% were of male gender, and the mean age of all patients was 76.3 ± 4.2 years. Table 1 shows all comorbidities and characteristics of patients.

Table 1.

Patients’ characteristics.

Patients characteristics (Total n = 41)
Male gender (n, %)	35 (85.3%)
Mean age (years ± SD)	76.3 ± 4.2
Age >75 (n, %)	30 (73.2%)
Comorbidities
Arterial hypertension (n, %)	36 (87.8%)
Dyslipidemia (n, %)	37 (90.2%)
Diabetes mellitus (n, %)	22 (53.6%)
DM insulin-dependent (n, %)	15 (36.6%)
Smoking history	35 (85.3%)
Renal insufficiency (n, %)	10 (24.4%)
COPD (n, %)	12 (29.2%)
Coronary disease (n, %)	26 (63.4%)
Active cancer (n, %)	8 (19.5%)
Preoperative anticoagulants (n, %)	5 (12.2%)
Indication for extra-anatomic bypass
High surgical risk (n, %)	25 (61.0%)
Hostile abdomen (n, %)	5 (12.2%)
Coral reef aortic/iliac wall (n, %)	11 (26.8%)
Stage of ischemia
Rutherford stage III (n, %)	6 (14.6%)
Rutherford stage IV (n, %)	15 (36.6%)
Rutherford stages V–VI (n, %)	20 (48.8%)
Technical characteristics
7 mm graft (n, %)	11 (26.8%)
8 mm graft (n, %)	30 (73.2%)
PTFE graft (n, %)	41 (100%)
External support (n, %)	41 (100%)
Femoro-CFA graft (n, %)	13 (31.7%)
Femoro-DFA graft (n, %)	8 (19.5%)
Axillo-CFA graft (n, %)	6 (14.6%)
Axillo-DFA graft (n, %)	4 (9.8%)
Axillo-bi-CFA graft (n, %)	7 (17.1%)
Axillo-bi-DFA graft (n, %)	3 (7.3%)
SFA occlusion (n, %)	15 (36.6%)
Preoperative proximal angioplasty (n,%)	0
Endarterectomy at the distal anastomosis (n, %)	2 (4.9%)
Postoperative single ATP (n, %)	15 (36.6%)
Postoperative dual ATP (n, %)	15 (36.6%)
Postoperative ATP plus ATC (n, %)	11 (26.8%)

DM: diabetes mellitus; COPD: chronic obstructive pulmonary disease; PTFE: Polytetrafluoroethylene; CFA: common femoral artery; DFA: deep femoral artery; SFA: superficial femoral artery.

Regarding clinical presentation, six patients were treated for severe claudication (<50 m; Rutherford stage III), 15 patients for rest pain (Rutherford stage IV), and 20 patients for ischemic ulcer or gangrene (Rutherford stages V and VI).

The following procedures were recorded: Femoro-common femoral artery bypass (FCFB; n = 13), Femoro-deep femoral artery bypass (FDFB; n = 8), Axillo-common femoral artery bypass (AxCFB; n = 6), Axillo-deep femoral artery bypass (AxDFB; n = 4), Axillo-bi-common femoral artery bypass (Ax-bi-CFB; n = 7), and Axillo-bi-deep femoral artery bypass (Ax-bi-DFB; n = 3). All procedures were conducted using synthetic grafts (Polytetrafluoroethylene (PTFE) in all patients with external rings) (Figures 1 and 2). Regarding postoperative antithrombotic treatment, 15 patients received single antiplatelet therapy, 15 patients received dual antiplatelet therapy, and 11 patients received combined antiplatelet and anticoagulant therapy.

Figure 1.

(a) Left iliac artery occlusion; (b) first infected ischemic ulcer in the left heel region; (c) second infected ischemic ulcer in the left Achilles region; (d) femoro-femoral bypass grafting with synthetic graft.

Figure 2.

(a) Coral reef aorta; (b) aorto-iliac occlusion with extensive calcification; (c) right femoral artery bifurcation with extensive calcification; (d) left femoral artery bifurcation with extensive calcification; (e) axillo-femoral synthetic graft with right distal anastomosis at the deep femoral artery; (f) left distal anastomosis at the deep femoral artery.

Indications for an extra-anatomic procedure included the following: coral reef aortic/iliac wall (n = 11), high surgical risk (n = 25), and hostile abdomen (n = 5).

Regarding 30-day outcomes, there was no death, no myocardial infarction, no major bleeding, no graft infection, and no major amputation. In 12 patients, the primary procedure was followed by a minor amputation due to gangrene (toes). All minor amputations were scheduled. There were eight patients presenting with local wound complications that were treated conservatively with success (Table 2).

Table 2.

Early and late outcomes.

Early outcomes (within 1 month; n = 41)
Mortality (n, %)	0
Stroke (n, %)	0
Myocardial infarction (n, %)	0
Major bleeding (n, %)	0
Graft infection (n, %)	0
Wound complications (n, %)	8 (19.5%)
Major amputation (n, %)	0
Minor amputation (n, %)	12 (29.2%)
Late outcomes (>1 month; n = 35)
Mean follow-up (years ± SD)	6.5 ± 1.2
Total survival (n, %)	31/35 (88.6%)
Graft-related mortality (n, %)	0
Graft occlusion (n, %)	2/35 (5.7%)
Failing grafts (n, %)	2/35 (5.7%)
Major amputation (n, %)	0
Minor amputation (n, %)	0
Five-year primary patency (%)	88.6%
Five-year primary-assisted patency (%)	94.3%
Five-year secondary patency (%)	94.3%

Regarding follow-up, six patients (14.6%) were lost after the first month. For the remaining 35 patients, the mean follow-up was 6.5 ± 1.2 years. There were two late graft occlusions (one FDFB and one Ax-bi-DFB) leading to claudication without having to proceed with an additional procedure. Five-year primary patency was 88.6%, primary-assisted patency was 94.3% as an additional iliac stenting was needed for two failing FCFB grafts, and secondary patency was also 94.3% as no secondary procedure was needed for the two occlusions (Figure 3). Limb salvage was also 100% as no major amputation was recorded within follow-up. No minor amputation was recorded within follow-up either. Within follow-up, four out of thirty-five patients died due to cancer (n = 2) or due to cardiac causes (n = 2). Therefore, five-year all-cause survival was estimated to be 88.6%.

Figure 3.

Kaplan–Meier curves for primary, primary-assisted, and secondary patencies.

Multivariate analysis showed that only endarterectomy at the distal anastomosis was associated independently with worse patency in the long-term (OR = 5.356; 95% CI (1.012–185.562); p = .041) (Table 3).

Table 3.

Univariate and multivariate analyses for long-term patency.

Factors	OR, CI 95%	p-Value
Univariate analysis
Male gender	1.061 (0.041–27.302)	0.972
Age >75	0.357 (0.018–6.851)	0.495
Arterial hypertension	1.061 (0.041–27.302)	0.972
Dyslipidemia	1.061 (0.041–27.302)	0.972
Diabetes mellitus	0.900 (0.049–16.595)	0.943
DM insulin-dependent	0.197 (0.021–1.895)	0.159
Renal insufficiency	0.527 (0.021–12.821)	0.694
COPD	0.527 (0.021–12.821)	0.694
Smoking history	1.061 (0.041–27.302)	0.972
Coronary disease	0.461 (0.024–8.693)	0.606
Active cancer	3.750 (0.189–74.068)	0.385
Anticoagulant	1.400 (0.051–38.454)	0.842
Rutherford stages IV–VI	1.061 (0.041–27.302)	0.972
Occlusion of recipient SFA	10.384 (0.433–249.050)	0.148
7 mm graft	2.800 (0.146–53.709)	0.494
Inflow intervention	-	-
Endarterectomy at the distal anastomosis	57.000 (1.562–2080.742)	0.027
Femoro-DFA graft	5.333 (0.256–110.803)	0.279
Axillo-bi-DFA graft	5.333 (0.256–110.803)	0.279
Multivariate analysis
Endarterectomy at the distal anastomosis	5.356 (1.012–185.562)	0.041

DM: diabetes mellitus; COPD: chronic obstructive pulmonary disease; DFA: deep femoral artery; SFA: superficial femoral artery.

Discussion

In this series, we showed that ExAB grafting for severe AIOD is a safe and durable treatment taken into consideration that there were some patients lost to follow-up. We also found that endarterectomy at the distal anastomosis site was the only independent factor for worse patency during the follow-up.

Regarding AIOD, first-line treatment includes endovascular repair for less extensive lesions and anatomic bypass for low-risk patients with extensive occlusions.⁶ However, the aforementioned techniques have their limits, especially in the case of extensive occlusions or patients of higher surgical risk, respectively. In our series, the main indications for applying ExAB included coral aortic wall, severe comorbidities, and a hostile abdomen. This concurs with other studies where reasons for performing AxFB or FFB rather than orthotopic bypass were mainly a hostile aorta, high surgical risk, prior failed reconstruction, advanced age, infection, a and hostile abdomen.^7,8 Additionally, FFB may also be used as an adjunct procedure for endovascular aortic/iliac aneurysm repair when there is a unilateral iliofemoral occlusion.⁸

Coral reef aorta is a rare but potentially lethal disease, where more than 70% of the aortic circumference is severely calcified.⁹ It is also associated with a high morbidity including renovascular hypertension, intermittent claudication, abdominal angina, congestive heart failure, and renal insufficiency.¹⁰ In a previous series, we have also underlined the difficulties of aortic cross-clamping in cases with coral reef aorta.¹¹ Although novel techniques have been described for completing the proximal anastomosis during an orthotopic bypass in such cases, there is always a risk for aortic wall injury and complications.^12,13 Therefore, most of authors suggest percutaneous techniques for less complex lesions and orthotopic bypass for good-risk patients with extensive occlusions, leaving the ExAB for high-risk patients with extensive lesions.¹⁴ Finally, ExAB is indicated mostly for CLI, although there are authors that have applied such procedures both for severe claudication and CLI concurring with our strategy.¹⁴

FFB remains the treatment of choice for patients with unilateral iliac occlusion who are not suitable for endovascular and orthotopic bypass procedures.¹⁵ Regarding major outcomes, a recent systematic review reveals a very low mortality ranging from 0% to 8%, concurring with our results.⁸ The most frequently reported complications include hematoma/bleeding, wound healing problems, wound infections, graft infections, graft thrombosis/occlusion, and false aneurysm formation.⁸ Reported primary patency rates vary between 71% and 94% at 1 year, 49% and 89% at 5 years, and 48% and 84% at 10 years, while secondary patency rates are between 79% and 98% at 1 year, 68% and 93% at 5 years, and 63% and 83% at 10 years.⁸ Major amputation is also reported in 1.4% to 3.5% of cases.⁸ Our five-year patency and limb-salvage rates concur with these results. Secondary graft patency is usually not much higher than primary patency like in our study because these patients often present late, and without severe recurrence of ischemia, and only few grafts are revised or salvaged.¹⁶ Although this procedure has an inferior long-term durability compared to orthotopic bypass, this is overshadowed by its low early mortality and morbidity.^5.8 Due to the optimal early outcomes, this type of repair has been used for patients with disabling claudication as well, yielding satisfactory patencies.¹⁷ In a multicenter randomized trial, the patency rates were significantly higher after direct bypass although rates for extra-anatomic surgery were quite satisfactory.¹⁵ Determination of the status of the donor iliac artery is a key factor for successful crossover bypass. Recently, by adding transluminal angioplasty or endarterectomy at the donor site, more patients have become suitable candidates for FFB.¹⁸

AxFB has been applied in the literature for challenging cases with severe comorbidities and without an indication for aortofemoral bypass. AxFB shows a lower mortality rate, shorter operative time, and intraoperative blood loss, although the postoperative thrombosis rate is higher.¹⁹ Early mortality, hospital stay duration, and complication rates are even comparable to endovascular treatment.⁷ Other postoperative complications include skin infection, early graft occlusion, and graft infection. Although no late revision was observed in our series, Appleton et al. report thrombectomy in 10.3% of cases, further surgery in 9.2%, and removal of graft in 6.9%, leading to a major amputation in 12.6% of cases.³ Other authors have also reported graft-related complications in more than 50% of patients.¹ Despite the inferior patency of AxFB grafts compared to aortofemoral grafts, limb salvage rates remain high, allowing patients to return to an acceptable level of activity and more independent lifestyle.^20,21 Therefore, these two strategies should be viewed as complimentary according to many authors.^21,22 Igari et al. report a 92.9% five-year limb salvage although five-year primary patency was only 53.6%.¹⁹ Unilateral and bilateral AxFB grafts show no difference regarding primary patency as well.²³ Due to more comorbidities, these patients have shown a lower overall survival rate in the long-term than those who undergo aortofemoral bypass.²⁴ Deaths during follow-up refer mainly to cardiac causes and respiratory disease. Other causes include vascular complications, cancer, stroke, and sepsis, concurring with our findings.³

Regarding the optimal graft type, synthetic grafts are preferred in general. Autologous grafts are not preferred in contrast to infrainguinal bypasses, for the following reasons: first, the graft should be quite long, especially in case of AxFB, and second, the pressures applied on a venous graft could lead to early graft thrombosis. There is no conclusive data on the best material, with Dacron and PTFE grafts showing similar long-term patency.¹⁷ In two randomized trials comparing different materials for extra-anatomic grafts, no difference in patency was observed.^25,26 However, an externally supported graft seems to show superior results.²⁷ Nowadays, PTFE grafts are the most commonly used. Some authors support the use of Dacron as a porous graft may be optimal to prevent neointimal disruption. For bilateral AxFB grafts, some authors also support to perform the femorofemoral portion off the femoral artery and not off the graft to ensure maximum flow.¹ The proximal anastomosis should be performed from the most proximal part of the artery to avoid any stress from shoulder movement. Finally, a better categorization of all the above variables is needed to report the real effect and avoid any bias.

Regarding potential predictors of outcome, several factors have been found to affect the longevity of FFB grafts including urgency of operation, donor iliac intervention, diameter of graft, and location of distal anastomosis.²⁸ However, we found that only the endarterectomy of distal anastomosis site had a negative effect on late patency. Donor iliac artery as well as the distal arterial tree has been found to play a significant role for durability as well.²⁸ Therefore, it is common that FFB is combined with angioplasty and stenting of the proximal donor iliac axis either primarily or secondary if the bypass is threatened. There are, however, controversial data regarding the benefit of combined repairs.^16,29 Aburhama et al. have concluded that a concomitant iliac angioplasty has favorable results only when the iliac stenosis is shorter than 5 cm in length.²⁹ Additionally, other authors have found that hypertension, dyslipidemia, single patent tibial runoff, and operations performed after previous graft failures significantly affected the long-term patency of FFB.^2,27,30 Harrington et al. have found that distal endarterectomy has been associated with adverse outcomes concurring with our results.³¹ CLI has been associated with inferior outcomes compared to claudication in the literature although we found no such association.^16,29,30 Several other factors have been associated with improved outcomes such as better anesthesia, new antiplatelet agents, better training of surgeons, and improvements in ultrasound for graft surveillance.⁷ Finally, there are some authors that have found no major prognostic factors for long-term outcomes.³²

Considering the proper perioperative medical coverage, guidelines recommend an antiplatelet for all patients treated with a revascularization procedure for lower limb ischemia.³³ While the role of antiplatelets in secondary prevention of coronary and cerebrovascular occlusive disease is undisputable, their benefit in peripheral occlusive disease is controversially discussed in primary prevention. Recently, the initiation of anticoagulants has also been evaluated for patients with peripheral artery disease. The VOYAGER trial has underlined the benefit of adding a low-dose of novel anticoagulants to standard antiplatelet treatment on patients undergoing vascular surgery procedures although the majority of patients in this trial were treated for infrainguinal disease.³⁴ ExAB raises certain challenges due to the higher risk for thrombosis and late failure. Therefore, several combinations of antiplatelet and anticoagulant regimens have been prescribed by physicians in order to improve long-term outcomes. In a large study with more than 2700 extra-anatomic procedures, only 19% received anticoagulation and 22% dual antiplatelet treatment (DAPT) in the long-term. There was no difference between the two regimens with regard to graft patency.³⁵ The authors report that anticoagulants used to be prescribed for grafts of higher risk and DAPT for patients with coronary artery disease in that study.³⁵ Mohan et al. have also compared antiplatelets and anticoagulants for the coverage of AxFB grafts without finding any difference.³⁶ This concurs with our findings, where the use of anticoagulants did not have an effect on graft durability. Therefore, there is no specific recommendation for such grafts.

There are many limitations in this study. First, the majority of patients were of male gender, and a high number of patients were lost during follow-up. This was mainly attributed to the lower social/financial status and the behavior of the patients presenting with CLI. However, we have conducted analysis on the total of remaining patients in order to minimize any bias or false interpretation. Second, the total number of patients is low to evaluate potential predictors. Therefore, univariate analysis found only one factor affecting outcomes. One should underline that the number of adverse events is very low, while the number of patients lost during the follow-up is very high. Additionally, as this study is a retrospective study conducted in a single institution, it may contain bias considering the selection of patients, the type of graft and repair selected by the physicians, as well as the medical treatment of such patients.

In conclusion, FFB and AxFB is a safe and durable strategy for treating patients with severe AIOD where no other option is feasible. Regarding predictors, only endarterectomy at the distal anastomosis site has been associated with an increased risk for lower patency.

Footnotes

Author contributions

G.G. and G.C. conceived the study and were involved in protocol development. G.G., A.T., V.M., N.I., and D.K. were involved in literature research, patient recruitment, and data analysis. G.G., G.C., and A.C. wrote the first draft of the manuscript. K.Z. and F.S. conducted a critical review of the draft. K.F. had the overall responsibility. All authors reviewed and edited the manuscript and approved the final version of the manuscript.

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.

Ethics statement

Guarantor

KF.

ORCID iD

George Galyfos

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Extra-anatomic bypass procedures for severe aortoiliac occlusive disease—A cohort study

Abstract

Objectives

Methods

Results

Conclusions

Keywords

Introduction

Methods

Results

Discussion

Footnotes

Author contributions

Declaration of conflicting interests

Funding

Ethics statement

Guarantor

ORCID iD

References