Endovascular Revascularization of Native Arteries After Bypass Graft Failure in Patients With Critical Limb Ischemia

Abstract

The aim of this study was to evaluate the success rate of endovascular revascularization of native infrainguinal arteries following the occlusion of bypass grafts. Materials and Methods: We performed a retrospective review of patients with critical limb ischemia (CLI) who underwent endovascular recanalization of chronic occluded native arteries after failure of femoropopliteal bypass grafts between 2014-2017. Data collected included patient demographics, site of occluded arteries, type and number of bypasses performed, and details of endovascular revascularization. Technical success, freedom from primary amputation, and hospitalization days were recorded. Results: Fourteen male patients with 15 limbs, (mean age 72 years ±6.2), were evaluated. Six limbs presented with Rutherford class 4, 6 with Rutherford class 5, and 3 limbs with Rutherford class 6. All arterial lesions were in the femoropopliteal segment. Thirteen were classified as TASC II class D and two as class C. Eleven limbs had undergone 1 surgical bypass, 3 limbs had 2, and 1 limb had 3 bypasses. The native vessels were occluded for a mean of 91.9 months (±68.7 months). Technical success was achieved in all cases, with stent placement in 14 out of the 15 limbs. Mean follow-up was 14.1 months. One patient underwent amputation of the affected limb. Conclusion: Revascularization of native femoropopliteal arteries after failure of bypass surgery is feasible and should be considered as a treatment option before limb amputation.

VASCULAR DISEASE MANAGEMENT 2020;17(6):E121-E125

Key words: critical limb ischemia, bypass graft, chronic total occlusion

Continuous advances in endovascular techniques and equipment have increased the therapeutic options for patients with critical limb ischemia (CLI). The treatment of such patients is no longer limited by the TASC II guidelines.¹ Endovascular management of femoropopliteal TASC C and D lesions has become feasible.^2,3 There is increasing literature comparing surgical bypasses to endovascular treatment, with similar amputation-free rates.^4-7 

Patients treated with infrainguinal bypasses have shown to have generally good long-term outcomes, though diabetes, young age, and hyperlipidemia are significant predictors of graft failure.⁸ Autologous vein grafts appear to achieve superior patency rates as compared to artificial grafts.^9,10 Graft occlusion is a significant complication. In a 2006 meta-analysis, primary patency of venous grafts decreased from 83.4% in the first year to 69.4% in the fifth year, and over the same time period, primary patency for polytetrafluoroethylene (PTFE) grafts decreased from 76.3% in the first year to 48.3 in the fifth year.¹¹ Another study showed patency of 80% for the saphenous vein and 69% for PTFE after two years.¹²

Not all patients with CLI following bypass graft occlusion are candidates for reoperation due to a lack of conduit, unsuitable target vessels, and high surgical risk.^13,14 Percutaneous interventions in occluded bypass grafts have proven to be feasible and have acceptable success rates.^15,16 However, patients with occluded bypass grafts who require revascularization have a worse outcome, with increased wound infections and amputation rates.¹⁷ In addition, percutaneous intervention in chronically occluded grafts is frequently not an option. In a patient who is unsuitable for additional bypass surgery, limb amputation is likely if percutaneous revascularization of the bypass is unsuccessful.^16,18 There is very little published information regarding recanalization of native arteries following occlusion of lower extremity bypasses.

The purpose of this study is to report technical success and short-term outcome following recanalization of native infrainguinal arteries after bypass graft failure in patients with CLI. 

Material and Methods

This retrospective review was approved by the institutional review board. For this type of study, formal consent is not required, but informed consent was obtained from all individual participants included in the study prior to the procedure.

Patient Selection. A retrospective review of all patients who underwent percutaneous endovascular interventions between the years 2014-2017 was performed. Within this population, we identified all patients who underwent endovascular revascularization of their native arteries after they experienced occlusion of previously performed bypass grafts. The resulting group is the cohort of this study.   

Patient Characteristics. All patients suffered from CLI and all had previously undergone at least one lower extremity arterial bypass, either with autologous or synthetic conduits. None of the patients were suitable candidates for repeat bypass surgery due to medical comorbidities, lack of a conduit, or an absent or unsuitable target vessel. Each case was discussed by a vascular board, comprised of vascular surgeons and interventional radiologists, to determine the best treatment option.

Data collected included patient demographics, comorbidities, Rutherford category and TASC classification, number and type of bypasses, and time from occlusion to recanalization. Reintervention rates and need for major amputation were also recorded.  

Definitions. Technical success was defined as recanalization of the native lesions with residual stenosis less than 30%. Native arterial occlusion time was defined as the time between the first bypass graft surgery to recanalization date. 

Interventional Technique. Computerized tomography angiography (CTA) or conventional angiography was conducted prior to the intervention. After the imaging study was performed, the interventional access site was chosen in consideration of the patient’s body habitus, arterial tree patency, and previous procedures. All procedures were performed in a dedicated angiography suite (Axiom Artis zee, Siemens Healthineers) by an interventional radiologist (BH) with 15 years of experience and a fellow. 

Endovascular recanalization of the native vasculature was conducted from the femoral artery, in either an ipsilateral antegrade or contralateral retrograde approach. Occasionally, additional retrograde recanalization was performed with subintimal arterial flossing with antegrade-retrograde intervention (SAFARI technique).  Following arterial access with a 6 French (Fr) sheath (Terumo), intravenous heparin was administered to achieve activated clotting time (ACT) values between 250-300 seconds. Vasodilation medications were not used. For a contralateral approach, a curved 45 cm Destination sheath (Terumo), a 3 Fr TrailBlazer support catheter (Medtronic), and a 300 cm, 0.018- or 0.014-inch guidewire (Glidewire Advantage [Terumo] or Command [Abbott Vascular]) were used. For an ipsilateral antegrade approach, a short, 10 cm sheath (Radifocus Introducer II Standard kit [Terumo]) was used. When SAFARI technique was required, additional access via the pedal artery was gained using the 3 Fr inner dilator of a micropuncture set (AngioDynamics), the .018- or 0.014-inch 300 cm wire, and a 3 Fr Trailblazer for support. After crossing the occlusion, a 5 mm Amplatz Goose Neck snare kit (Medtronic) was used downstream to engage the guidewire. PowerCross .018-inch (Medtronic), NanoCross .014-inch (Medtronic), or Coyote (Boston Scientific) percutaneous transluminal angioplasty (PTA) balloons were used for popliteal arteries (4 x 100 mm or 4 x 120 mm) and for femoral arteries (5 x 200 mm), at the operators’ discretion. Depending on lesion location and diameter, stent placement was performed with a Supera (Abbott Vascular), Complete SE (Medtronic) or Xpert Pro (Abbott Vascular). The Outback LTD reentry device (Cordis, A Cardinal Health company) was used when deemed necessary, only after conventional and SAFARI techniques failed to gain luminal reentry. Recanalization of tibial arteries was attempted in all cases.

The ExoSeal closure device (Cordis, A Cardinal Health company) was used in all cases for femoral artery hemostasis. Hemostasis was achieved manually in pedal artery access.

Follow-Up. Follow-up was performed in an outpatient vascular surgery clinic at 1, 3, 6, and 12 months, and consisted of clinical exam, ankle-brachial index (ABI) measurements, and ultrasound duplex (USD). Limb salvage outcomes are reported as freedom from major amputation on follow-up out to one year. 

Results

During the study period, a total of 1640 endovascular lower extremity interventions were performed. The study group consisted of 14 patients with 15 limbs who underwent revascularization (0.91%). Patient demographics, comorbidities, and Rutherford class are summarized in Table 1. All patients were male, with a mean age of  72 years (±6.2 years). Six patients presented with Rutherford Class 4, 6 patients with Rutherford Class 5, and 3 patients with Rutherford Class 6. Details regarding lesion location, length, and previous bypass grafts are noted in Table 1. In 13 limbs, the lesions were classified as TASC II class D, and two limbs were class C.

Eleven limbs had undergone 1 bypass graft surgery, 3 limbs had 2 bypass graft surgeries, and 1 limb had 3 bypasses. The occluded grafts were as follows: reversed great saphenous vein (RGSV) in 11 limbs, polytetrafluoroethylene (PTFE) in 3 limbs, and a composite graft in 1 limb. Time of occlusion and bypass graft details are summarized in Table 2. 

In 5 limbs, the distal superficial femoral artery (SFA) and popliteal arteries were occluded. In 4 limbs, the occlusion extended from mid SFA and included the popliteal arteries. In 4 limbs, the SFA was occluded from its origin, and in 2 limbs, only the proximal part of the SFA was occluded. 

Occlusion time ranged between 10 months and 18 years, with a mean of 91.9 months or 7.65 years (±68 months). Occlusion length varied between 150 and 470 mm, with a mean length of 292 mm (±105 mm).

Prior to the procedure, there were 20 patent tibial arteries (3 arteries in 2 limbs, 2 arteries in 4 limbs, 1 artery in 6 limbs, and none in 3 limbs). Post recanalization, the outflow consisted of 32 tibial arteries (3 in 6 limbs, 2 in 5 limbs, and 1 in 4 limbs). Tibial arteries were treated with PTA only. 

Ten patients had a contralateral approach, 4 patients an ipsilateral approach, and 1 patient had a femoral-femoral graft. In 6 procedures, an additional ipsilateral retrograde approach from the pedal arteries (SAFARI technique) was required. The Outback reentry device was used in 3 procedures. Technical success was achieved in all procedures. Periprocedural complications occurred in one patient: an acute in-stent thrombosis that underwent successful resolution following 24-hour thrombolysis. Average hospitalization time following the procedure was 2.4 days (1-13). Mean follow up was 14.4 months (1-36).

Four patients were amputation free at 3 years, 1 patient was amputation free at 1 year, 3 patients were amputation free at 6 months, and 3 patients were amputation free 3 months after the procedure. One patient required an additional reintervention after 4 months because of acute thrombosis. He remains amputation free 6 months after the initial endovascular procedure. 

Four patients expired within a year of the procedure. One had repeat endovascular reintervention due to in-stent stenosis and recurrent leg ulcers 8 months after the native revascularization. Due to lack of resolution of his ischemic ulcers, he underwent below-knee amputation and died 7 days after surgery due to sepsis. Two patients died due to acute coronary syndrome, 4 and 11 months after the procedure. The fourth died due to pneumonia and multiorgan failure 6 months after the endovascular procedure. Their affected limb remained intact.

Discussion 

Patients who develop CLI following failed bypass surgery are a select and challenging group of patients. They frequently have limited or no options for additional bypasses, are not considered candidates for further percutaneous intervention, and are therefore left with amputation as the only treatment option.^14-16

This study showed the high technical success of native infrainguinal vascular revascularization in patients with a long-term CTO and failed bypass grafts who are not candidates for additional bypass procedures. Successful revascularization in these patients results in limb salvage. 

A few authors have recently reported on their experience with native artery recanalization of a longstanding chronic total occlusion (CTO) with the use of advanced endovascular techniques and equipment. Advanced capabilities for recanalization, not only for the femoropopliteal segments, but also for occluded tibial arteries, can also lead to better foot perfusion. Simosa et al described 24 lower extremities with failed bypass grafts treated endovascularly with native artery recanalization.¹⁵ Median time of graft failure was 21.6 months (range of 0.2-92 months). Native arterial occlusion length was not provided in the study. They reported 100% technical success. Limb salvage rate was 81.5% at 12 months. Yin et al reported endovascular treatment for 28 limbs with a failed bypass graft.²⁰ Graft period patency median was 22.5 months (range 3-97 months) with a median CTO length of 240 mm (range 100-370 mm). Technical success rate was 92.9%. Limb salvage rate was 91.6% at 12 months. Wrigley et al treated 19 limbs.²¹ Mean graft patency was 27 months for 15 of 19 patients. Average CTO length was 310 mm (range 140-600 mm). Technical success rate was 95%. Limb salvage rate was 87% at 12 months and 60% at 24 months. Gandini et al described endovascular treatment of 32 limbs, including 4 limbs with acute ischemia and 6 in the suprainguinal segment.²² Mean lesion length was 203 mm (range 120-450 mm). Arterial occlusion time was not provided. Technical success was achieved in 93.7%. Limb salvage was 90% at 30 months. Li et al reported 45 consecutive patients where the native SFA was treated following a failed femoropopliteal bypass.²³ Average CTO length was 298 mm (range 100-600 mm). It was reported that the period of previous graft patency was 32.8 months (range 5-95 months), meaning the native artery was occluded for this length of time. Limb salvage rate at 12 months was 95%.

In our study, the average length of occlusion was 292 mm, similar to other investigators. The median time of CTO presence was 91.8 months (7.5 years) and varied from 10 months to 18 years. The time period of arterial occlusion was longer in our study than in other studies. This time period did not play a role in the decision-making process, since the procedure was first and foremost aimed at limb salvage, but our study demonstrated that even after an extended period of time where a CTO is present, native artery endovascular recanalization can be successful and should be considered in order to save a limb. 

A meticulous and individualized approach was applied to achieve revascularization, using all accepted means for improvement of foot perfusion, including the SAFARI technique, application of a reentry device (Outback), and recanalization of tibial arteries to increase outflow. Technical success was achieved in all procedures. Limb salvage was achieved in all but one case, which resulted in amputation (as reported in the results).

The ability to treat longstanding CTOs and vasculature of the tibial arteries can be facilitated with the combination of an experienced, dedicated operator and recent advances in available endovascular equipment.

This study is limited by its small sample size from a single center and retrospective nature. All procedures were conducted by a single operator. The follow-up was limited to freedom from primary amputation and did not account for other variables such as vascular patency or clinical assessment. This patient population also had different types of arterial occlusion. The treatment approach was designed individually and varied accordingly. 

Conclusion

Revascularization of native vasculature after longstanding occlusion and failed surgical bypass is technically feasible. It should be considered as a treatment option before limb amputation, even in longstanding arterial CTOs.

Disclosure: The authors report no conflicts of interest regarding the content herein. Manuscript submitted July 15, 2019, final version accepted December 12, 2019.

Address for correspondence: Daniel Raskin, MD, Diagnostic Imaging Department, Sheba Medical Center, Tel-Hashomer 52621, Israel. Tel. +97235302530. Fax +97235357315.                        

Email: daniel.raskin@sheba.health.gov.il

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