Advertisement

Midterm Outcomes of Endovascular Therapy for TASC II D Femoropopliteal Lesions with Critical Limb Ischemia: A Retrospective Analysis

  • Peng Liu
    Affiliations
    Department of Vascular and Endovascular Surgery, Hebei Key Laboratory of Colorectal Cancer Precision Diagnosis and Treatment, the First Hospital of Hebei Medical University, Shijiazhuang, Hebei, PR China
    Search for articles by this author
  • Li-hua Zheng
    Affiliations
    Department of Vascular and Endovascular Surgery, Hebei Key Laboratory of Colorectal Cancer Precision Diagnosis and Treatment, the First Hospital of Hebei Medical University, Shijiazhuang, Hebei, PR China
    Search for articles by this author
  • Xin-qi He
    Affiliations
    Department of Vascular and Endovascular Surgery, Hebei Key Laboratory of Colorectal Cancer Precision Diagnosis and Treatment, the First Hospital of Hebei Medical University, Shijiazhuang, Hebei, PR China
    Search for articles by this author
  • Yan Yang
    Affiliations
    Department of Vascular and Endovascular Surgery, Hebei Key Laboratory of Colorectal Cancer Precision Diagnosis and Treatment, the First Hospital of Hebei Medical University, Shijiazhuang, Hebei, PR China
    Search for articles by this author
  • Li-ke Zhang
    Affiliations
    Department of Vascular and Endovascular Surgery, Hebei Key Laboratory of Colorectal Cancer Precision Diagnosis and Treatment, the First Hospital of Hebei Medical University, Shijiazhuang, Hebei, PR China
    Search for articles by this author
  • Lei Zhang
    Affiliations
    Department of Vascular and Endovascular Surgery, Hebei Key Laboratory of Colorectal Cancer Precision Diagnosis and Treatment, the First Hospital of Hebei Medical University, Shijiazhuang, Hebei, PR China
    Search for articles by this author
  • Feng Zhang
    Correspondence
    Correspondence to: Feng Zhang, Department of Vascular and Endovascular Surgery, Hebei Key Laboratory of Colorectal Cancer Precision Diagnosis and Treatment, the First Hospital of Hebei Medical University, Shijiazhuang, Hebei 050031, PR China
    Affiliations
    Department of Vascular and Endovascular Surgery, Hebei Key Laboratory of Colorectal Cancer Precision Diagnosis and Treatment, the First Hospital of Hebei Medical University, Shijiazhuang, Hebei, PR China
    Search for articles by this author
Open AccessPublished:August 22, 2022DOI:https://doi.org/10.1016/j.avsg.2022.08.004

      Background

      This study evaluated the midterm results of endovascular therapy (EVT) for Trans-Atlantic Inter-Society (TASC) II D femoropopliteal lesions in patients with critical limb ischemia (CLI).

      Methods

      Fifty seven limbs of 54 patients with CLI due to TASC II D femoropopliteal lesions who underwent EVT at the First Hospital of Hebei Medical University were retrospectively analysed in a single-centre, observational study. The patient characteristics, endovascular procedural details, freedom from target lesion revascularization (TLR), patency rates, ulcer healing rate, and limb salvage rate were accessed.

      Results

      The patients’ mean age was 68.2 ± 8.2 years. All patients were treated by EVT. The final technical success rate was 98.2% (56/57). There were 23 cases of pain at rest, 18 cases of ulcer, and 15 cases of gangrene. The median length of the treated segment was 286 ± 42 mm (56/56) and the mean number of stents placed per patient was 2.0 ± 0.8 (49/56). The postoperative ankle-brachial index was significantly higher than that of the preoperative ankle-brachial index (P < 0.05). The perioperative complication rate was 10.7% (6/56). The restenosis or occlusion rate was 44.6% (25/56). The estimated rates of freedom from TLR at 1 year, 2 years, and 3 years were 86.8%, 67.0%, and 62.5%, respectively. A univariate analysis showed that predictors of freedom from TLR were the number of runoff vessels, length of the lesion, and complexity of the lesion, while predictors for restenosis or occlusion were the length and the complexity of the lesion. The ulcer healing rate was 93.8%. The limb salvage rates were 76.4%, 74.4%, and 70.9% at 1, 2, and 3 years after treatment, respectively.

      Conclusions

      The midterm outcomes of EVT for TASC II D femoropopliteal lesions in patients with CLI indicated that this treatment approach is safe and effective and is clinically applicable.

        Type of Research

      • Single-centre retrospective observational study.

        Key Findings

      • EVT of TASC II D femoropopliteal lesions with CLI during EVT using or not stent in 54 patients followed up for 3 years results in 98.2% technical success rate, higher postoperative ABI, in 86.8% 1-year freedom from TLR, 93.8% ulcer healing, and 76.4% 1-year limb salvage.

        Take-Home Message

      • Using EVT to revascularize TASC II D femoropopliteal lesions with CLI is feasible with favorable perioperative outcomes.

      Introduction

      Peripheral artery disease (PAD) comprises different stages from asymptomatic stenosis to ischemic amputation
      • Aronow W.S.
      Peripheral arterial disease of the lower extremities.
      ,
      • Kinlay S.
      Management of critical limb ischemia.
      with a higher incidence rate in older people.
      • Norgren L.
      • Hiatt W.R.
      • Dormandy J.A.
      • et al.
      Inter-society Consensus for the management of peripheral arterial disease (TASC II).
      To facilitate the choice of best method of treatment for symptomatic PAD, the Trans-Atlantic Inter-Society Consensus (TASC) II redefined class D femoropopliteal lesions as long, chronic total occlusion (CTO) suggesting the need for open surgical revascularisation.
      • Stoner M.C.
      • Calligaro K.D.
      • Chaer R.A.
      • et al.
      Society for Vascular Surgery. Reporting standards of the Society for Vascular Surgery for endovascular treatment of chronic lower extremity peripheral artery disease.
      ,
      • Biagioni R.B.
      • Brandão G.D.
      • Biagioni L.C.
      • et al.
      Endovascular treatment of TransAtlantic Inter-Society Consensus II D femoropopliteal lesions in patients with critical limb ischemia.
      However, patients presenting critical limb ischemia (CLI) usually have poor physical fitness and are at high risk for open surgery. Additionally in recent years, with the accumulation of clinicians’ experience and technical and material advances, endovascular therapy (EVT) of complex, longer lesions of the lower limbs has become commonplace,
      • Patel S.D.
      • Biasi L.
      • Paraskevopoulos I.
      • et al.
      Comparison of angioplasty and bypass surgery for critical limb ischaemia in patients with infrapopliteal peripheral artery disease.
      and have achieved good clinical results with TASC II D femoropopliteal lesions.
      • Bracale U.M.
      • Giribono A.M.
      • Spinelli D.
      • et al.
      Long-term results of endovascular treatment of TASC C and D aortoiliac occlusive disease with expanded polytetrafluoroethylene stent graft.
      • Bosiers M.
      • Setacci C.
      • De Donato G.
      • et al.
      ZILVERPASS study: ZILVER PTX stent vs bypass surgery in femoropopliteal lesions.
      • Fowkes F.G.
      • Murray G.D.
      • Butcher I.
      • et al.
      Ankle Brachial Index Collaboration
      Ankle brachial index combined with Framingham Risk Score to predict cardiovascular events and mortality: a meta-analysis.
      The aim of this study was to evaluate the midterm safety and performance outcomes of the EVT, for the treatment of TASC II D femoropopliteal lesions in patients with CLI.

      Patients and Methods

      Patients

      From September 2016 to October 2020, 57 limbs of 54 patients referred for EVT of TASC II D femoropopliteal lesions with CLI were included in this observational, single-arm, single-institution, prospective study. Ankle-brachial index (ABI) measurement, Doppler ultrasound, and angiography-computed tomography (angio-CT) were performed before and after each scheduled endovascular procedure in all patients.
      PAD was clinically determined as per Rutherford stages. The inclusion criteria were as follows: age > 40 years, symptomatic (Rutherford 4, 5, 6), TASC II D lesion (CTO length of common femoral artery [CFA] and superficial femoral artery [SFA] > 20 cm, involving the popliteal artery),
      • Biagioni R.B.
      • Brandão G.D.
      • Biagioni L.C.
      • et al.
      Endovascular treatment of TransAtlantic Inter-Society Consensus II D femoropopliteal lesions in patients with critical limb ischemia.
      at least 1 run-off vessel continuous with the femoropopliteal segment, and informed consent given by the patient. Exclusion criteria were acute ischemia or acute thrombosis, known allergy to antiplatelet and contrast agent, pregnancy, previous endovascular and bypass surgery of target vessels, Buerger disease, and life expectancy < 1 year.
      This research was approved by the Medical Ethics Committee of The First Hospital of Hebei Medical University (20200345). All patients provided informed consent.

      Definitions

      Definitions are listed in Table I. The indication for stent implantation was residual stenosis > 30% or limited dissection. The area method was used to calculate the size of the foot ulcer. Calculation of the healing time was from the operation date to the last follow-up or day by which the foot ulcer had healed.
      • Rutherford R.B.
      • Baker J.D.
      • Ernst C.
      • et al.
      Recommended standards for reports dealing with lower extremity ischemia: revised version.
      The length of the arterial lesion was evaluated by using a radiopaque ruler during digital subtraction angiography.
      Table IDefinitions
      Technical successResidual stenosis < 30% and positive blood flow as assessed by angiography
      Clinical successAttained at least a level of claudication
      Target lesion revascularization (TLR)Revascularization of a treated arterial segment, performed on a patient who returned due to symptomatic recurrence and restenosis or occlusion as determined by duplex ultrasound, following EVT of femoropopliteal PAD
      Coronary artery diseaseHistory of angina, myocardial infarction, or prior coronary artery revascularization
      Cerebrovascular diseaseHistory of ischemic stroke, cerebral hemorrhage, and transient ischemic attack
      Complex lesionsInvolving femoral trifurcation including the CFA, the origin of the profound femoral artery (PFA), or flush occlusion of the SFA
      Major amputationAmputation above the level of the ankle joint
      Minor amputationAmputation at or below the ankle joint
      Primary patencyPersistent patency without any other revascularization in the treated arterial segment
      Assisted-primary patencyPersistent patency through new EVT in stenotic segment
      Secondary patencyDuration of patent revascularization after new intervention for occlusion
      RestenosisStenosis > 50% in the intervened vessel or a peak systolic velocity ratio > 2.4 on duplex ultrasound

      Procedures

      All the affected limbs underwent EVT. Procedures were performed under local or general anaesthesia by the same group of vascular surgeons. Access to the target lesion was determined using a 6 F 45-cm–long sheath (Fortress, Biotronik, Dresden, Germany), crossing over the aortic bifurcation, or using a 6 F 16-cm–long sheath (Radifocus, Terumo Corporation, Hanoi, Vietnam) via an antegrade approach. After sheath placement, unfractionated 100 IU/kg heparin was administered by injection. A 0.035-inch hydrophilic guidewire (150 cm, Radifocus, Terumo Corporation) crossed through the culprit lesions. The target vessel was first opened in the true lumen and a subintimal technique was used if this failed. To reduce damage, a balloon with a diameter 1 mm narrower than the target vessel was chosen. Predilation with small balloon catheter was performed for ≥ 2 min to limit the risk of dissection. Using a stent sizing selected to a 1:1 ratio to the normal artery segment diameter and extending at least 10 mm past the lesion proximally and distally. Adjacent stents were overlapped by 1 cm maximum. A radiopaque ruler was used to measure the length of the stented segment. Four types of nitinol self-expanding stents were implanted: Protégé Everflex (ev3, Plymouth, Minnesota), Aston Pulsar (Biotronik, Berlin, German), Lifestent (Bard peripheral vascular, Tempe, Arizona), and Zilver Flex (COOK, Limerick, Ireland). The routinely postdilated balloon after stenting was performed within the stented segment. In case of a percutaneous approach, groin closure was accomplished by manual compression or by using a vascular closure device (2-mm Perclose Proglide, Abbott Vascular, Diegem, Belgium).

      Drug Administration and Follow-Up

      Aspirin (100 mg/d) and clopidogrel (75 mg/d) were administered in the absence of contraindications at least 3 days before operation, after which only aspirin (100 mg/day) was continued.
      Follow-up visits of outpatient administration were commonly scheduled at 1, 3, 6, and 12 months after the procedure; thereafter, they were evaluated at 6-month intervals. Follow-up included an interview, health education with correction of cardiovascular risk factors, ABI, ultrasound imaging, and clinical examination.

      Statistical Analysis

      Data were analysed using SPSS 26.0 software. Continuous variables are presented as mean ± standard deviation. Categorical variables are presented as counts and percentages. Kaplan‒Meier analysis with log-rank testing was used to analyse primary patency, assisted-primary patency, and secondary patency rates. A univariate Cox regression model was fitted to investigate risk factors for freedom from target lesion revascularization (TLR) and restenosis or occlusion. The estimated effect of each variable was calculated as the hazard ratio with 95% confidence interval. A P value < 0.05 was considered significant.

      Results

      Characteristics of the Patients

      The technical success rate was 98.2% (56/57) (Fig. 1). In 1 patient, the guidewire did not cross the target lesion and surgical revascularization with bypass was required. This limb was excluded from analysis. Thus, 56 limbs of 54 patients were enrolled. The baseline demographic and clinical characteristics are described in Table II. The most common cardiovascular risk factors were hypertension and hypercholesterolemia, which were present in almost 80% of all patients. About half of patients were past or current smokers.
      Figure thumbnail gr1
      Fig. 1(A, B) Angiogram illustrates femoropopliteal occlusion. (C–F) Angiogram shows the patent femoropopliteal segment after the percutaneous transluminal angioplasty and stenting.
      Table IIBaseline patient characteristics
      VariablesValue
      Number of patients, n (limbs)54 (56)
      Male, n (%)41 (75.9)
      Age (years, mean ± SD)68.2 ± 8.2
      Smoking, n (active/previous)14/25
      BMI > 24, n (%)26
      Preoperative course (months, mean ± SD)3.8 ± 1.6
      Length of hospital stay (days, mean ± SD)13.5 ± 5.1
      Coronary heart disease, n (%)13
      Cerebrovascular disease, n (%)6
      Hypertension, n (%)44
      Dyslipidaemia, n (%)45
      Diabetes, n (type I/II)0/15
      Renal insufficiency, n (%)10
      Rutherford Classification, n (4/5/6)23/18/15
      Follow-up time (months, mean ± SD)31.7 ± 12.0

      Outcomes of Perioperative Course

      The average baseline Rutherford class was 4.9 ± 0.8. This decreased to 1.3 ± 1.4 at 12 months (54 limbs, P < 0.001) after the intervention. The baseline ABI was 0.17 ± 0.1 and increased to 0.89 ± 0.1 at 1 month (55 limbs, P < 0.001) and remained at 0.85 ± 0.1 at 12 months (49 limbs). No clinical worsening was found. Of the 56 limbs in this group, 49 (87.5%) required a secondary stenting procedure because of an inadequate percutaneous transluminal angioplasty (PTA) result. Stented lesions were significantly longer (28.7 ± 4.5 cm vs. 23.0 ± 1.7 cm; P = 0.001) than those that underwent PTA only.
      The endovascular procedural details are described in Supplementary Table S1. During the perioperative period, 6 limbs developed procedure-related complications: 2 cases of myocardial infarction with 1 procedure-related death; 1 case of ischemic stroke, 1 case of in-stent acute thrombosis and 1 case of distal embolization, both of which were treated successfully with thrombolytic therapy; 1 case of pseudoaneurysm that required open surgery; and 1 case of local bleeding at the site of vascular access, requiring blood transfusion without surgery. Except for the cases of reoperation and death, other complications were conservatively treated, with good results before discharge. Complete follow-up data were obtained from 94.6% (53/56) patients. The mean time of follow-up was 31.7 ± 12.0 months (range: 1–61 months).

      Vascular Patency and TLR

      As per Kaplan‒Meier analysis, the primary patency rates at 1 year, 2 years, and 3 years were 84.9%, 34.7%, and 20.2%, respectively, with a median time of 19 months. The assisted-primary patency rates at 1 year, 2 years, and 3 years were 88.7%, 44.4%, and 21.8%, respectively, with a median time of 22 months. The secondary patency rates were 98.1%, 55.8%, and 31.5%, respectively, with a median time of 24.5 months (Fig. 2).
      Figure thumbnail gr2
      Fig. 2Kaplan‒Meier curves for primary patency, primary-assisted patency, and secondary patency.
      During the follow-up period, 17 lesions (4 with rest pain, 5 with ulceration, and 8 with gangrene) required TLR. The estimated rates of freedom from TLR at 1 year, 2 years, and 3 years were 86.8%, 67.0%, and 62.5%, respectively. Univariate analysis showed that predictors of freedom from TLR were a greater number of runoff vessels (P = 0.004), shorter length of lesions (P = 0.038), and the absence of complex lesions (P = 0.036) (Supplementary Table S2).

      Risk Factors for Restenosis or Occlusion

      Overall, 8 of 12 (66.7%) symptomatic restenosis and 10 of 13 (76.9%) symptomatic reocclusion cases successfully underwent reintervention by EVT during the follow-up period. However, in 1 limb of a patient with technical failure, surgical bypass was required. Five limbs were treated with rotational atherectomy, covered stents were implanted in 6 limbs, while a paclitaxel-coated balloon was used in 10 limbs at the site of restenosis or occlusion. Univariate analysis revealed that predictors of restenosis or occlusion were the longer lesion (P = 0.049) and the presence of more complex lesions (P = 0.025) (Supplementary Table S3).

      Ulcer Healing

      The ulcer area was determined in 16 patients as 1.0–5.3 cm2, with an average of 2.3 ± 1.3 cm2. The ulcer healing rate was 93.8% (15/16). In 15 cases, wound healing was achieved rapidly after intervention (8–28 days), with an average of 13.4 ± 5.9 days (Supplementary Fig. S1). One patient with ulcer progression, who did not achieve complete healing, required minor amputation due to the gangrene in the toes.

      Limb Salvage Rate

      The limb salvage rates in the 56 limbs were 76.4%, 74.4%, and 70.9% at 1 year, 2 years, and 3 years, respectively. At the end of follow-up, 15 amputations had been performed, including 4.3% (1/23) in the rest pain group, 5.6% (1/18) in the ulceration group, and 86.7% (13/15) in the gangrene group. These included 6 cases of major amputation (Fig. 3) and 9 cases of minor amputation. The other 2 cases of gangrene were successfully salvaged by skin flap transplantation and other techniques (Fig. 4). Complete healing of skin lesions occurred in 14 of 15 limbs, while the remaining patients required reoperation due to the reocclusion of the treated lesion and had not undergone surgery by the time of the last follow-up.
      Figure thumbnail gr3
      Fig. 3Rutherford 6, Gangrene patient; 76-year-old male underwent major amputation because of in-stent reocclusion.
      Figure thumbnail gr4
      Fig. 4Rutherford 6, Gangrene patient; a 78-year-old male underwent surgical debridement, negative pressure wound therapy, and skin grafting after endovascular therapy.

      Discussion

      Surgery remained the primary treatment choice for TASC II D lesions. However, advances in endovascular techniques and products for interventional therapy have been reported to have improved the efficacy of EVT for longer lesions,
      • Katsanos K.
      • Tepe G.
      • Tsetis D.
      • et al.
      Standards of practice for superficial femoral and popliteal artery angioplasty and stenting.
      particularly for older and fragile patients in whom open surgical revascularization under general anaesthesia is contraindicated and for patients undergoing dialysis and those with coronary artery disease and cerebrovascular disease.
      • Veraldi G.F.
      • Mezzetto L.
      • Macrì M.
      • et al.
      Comparison of endovascular versus bypass surgery in femoropopliteal TASC II D lesions: a single-center study.
      ,
      • Meyer A.
      • Lang W.
      • Borowski M.
      • et al.
      CRITISCH collaborators
      In-hospital outcomes in patients with critical limb ischemia and end-stage renal disease after revascularization.
      This study reported the midterm (3-year) outcomes of EVT, with vessel preparation by PTA, with or without the implantation of 1 or several self-expansible bare-metal stents, in TASC II D femoropopliteal lesions with CLI. The overall technical success rate was high (98.2%). Using EVT for TASC II D femoropopliteal lesions yielded acceptable results at 1, 2, and 3 years with satisfactory patency.
      However, our results were somewhat discouraging in that the patency rates detected were lower than those previously reported.
      • Patel S.D.
      • Biasi L.
      • Paraskevopoulos I.
      • et al.
      Comparison of angioplasty and bypass surgery for critical limb ischaemia in patients with infrapopliteal peripheral artery disease.
      ,
      • Guo X.
      • Xue G.
      • Huang X.
      • et al.
      Outcomes of endovascular treatment for patients with TASC II D femoropopliteal occlusive disease: a single center study.
      This outcome can be attributed to the following: first, we analysed only limbs with TASC II D lesions to reduce bias and the treated lesions were longer (mean length: 286 ± 42 mm) than those in other studies;
      • Guo X.
      • Xue G.
      • Huang X.
      • et al.
      Outcomes of endovascular treatment for patients with TASC II D femoropopliteal occlusive disease: a single center study.
      ,
      • Kedora J.
      • Hohmann S.
      • Garrett W.
      • et al.
      Randomized comparison of percutaneous Viabahn stent grafts vs prosthetic femoral-popliteal bypass in the treatment of superficial femoral arterial occlusive disease.
      second, implantation of different types of nitinol self-expandable metal-bare stents played an important role in the low patency rate. Finally, the primary patency rates of patients suffering from claudication appear to be higher than that of patients with CLI,
      • Brouillet J.
      • Deloose K.
      • Goueffic Y.
      • et al.
      Primary stenting for TASC C and D femoropopliteal lesions: one-year results from a multicentric trial on 203 patients.
      and the latter were predominant in our study.
      A previous study demonstrated that using primary stents as the first treatment option in femoropopliteal lesions yielded superior outcomes as compared to PTA alone, because of the elastic recoil, residual stenosis, and dissection that occurs in moderate/long-length lesions.
      • Acin F.
      • de Haro J.
      • Bleda S.
      • et al.
      Primary nitinol stenting in femoropopliteal occlusive disease: a meta-analysis of randomized controlled trials.
      ,
      • Elmahdy M.F.
      • Buonamici P.
      • Trapani M.
      • et al.
      Long-term primary patency rate after nitinol self-expandable stents implantation in long, totally occluded femoropopliteal (TASC II C & D) lesions.
      In our context, which involved only TASC II D femoropopliteal lesions, there was no significant difference in TLR and primary patency between groups who underwent PTA only and those who received stents. This may be related to the shorter-length lesions in the PTA group (23.2 ± 2.6) than in the stent group (28.3 ± 4.3, P = 0.004). In addition, the small sample size (n = 7) in the PTA-only group was insufficient for accurate estimation of clinical outcomes. In the early stages of this study, a PTA-only strategy provided less satisfactory results for long femoropopliteal lesions than did angioplasty and stent implantation.
      The length of the lesion could determine the patency outcomes after revascularization, particularly EVT.
      • Norgren L.
      • Hiatt W.R.
      • Dormandy J.A.
      • et al.
      Inter-society Consensus for the management of peripheral arterial disease (TASC II).
      ,
      • Rocha-Singh K.J.
      • Jaff M.R.
      • Crabtree T.R.
      • et al.
      VIVA Physicians, Inc. Performance goals and endpoint assessments for clinical trials of femoropopliteal bare nitinol stents in patients with symptomatic peripheral arterial disease.
      Primary patency rates appear to be higher in patients suffering from claudication rather than those with CLI and fall substantially with the increase in the mean treated lesion length.
      • Kedora J.
      • Hohmann S.
      • Garrett W.
      • et al.
      Randomized comparison of percutaneous Viabahn stent grafts vs prosthetic femoral-popliteal bypass in the treatment of superficial femoral arterial occlusive disease.
      In our study, longer femoropopliteal lesions had a lower freedom from TLR rate and a higher rate of restenosis or occlusion. Moreover, the freedom from TLR rate was significantly lower in complex femoropopliteal TASC II D lesions involving the CFA, and the incidence of restenosis or occlusion was significantly higher in these lesions.
      • Elmahdy M.F.
      • Buonamici P.
      • Trapani M.
      • et al.
      Long-term primary patency rate after nitinol self-expandable stents implantation in long, totally occluded femoropopliteal (TASC II C & D) lesions.
      The patency rate for lesions involving the CFA may be considered a contraindication to the use of EVT,
      • Hartung O.
      • Otero A.
      • Dubuc M.
      • et al.
      Efficacy of Hemobahn in the treatment of superficial femoral artery lesions in patients with acute or critical ischemia: a comparative study with claudicants.
      as this rate was lower than that in the group of simple femoral popliteal artery lesions. From a technical standpoint, femoral artery bifurcation near the joint involves a large range of motion and complex hemodynamics. Furthermore, PTA and stenting at the SFA origin is likely to damage the ostium of the profound femoral artery. Finally, considering the risk of stent fracture and occlusion, the implantation of a stent at the groin is usually not advisable.
      Several previous studies have defined a hybrid operation as a combination of proximal SFA open surgery with distal EVT and have suggested that this is an effective alternative to EVT only for the treatment of femoropopliteal lesions involving bifurcation of the femoral artery.
      • Murakami A.
      Hybrid operations in patients with peripheral arterial disease.
      ,
      • Kang J.L.
      • Patel V.I.
      • Conrad M.F.
      • et al.
      Common femoral artery occlusive disease: contemporary results following surgical endarterectomy.
      Moreover, these studies have reported that use of an autogenous vein and artificial vessel would likely achieve better clinical outcomes and superior long-term patency but with longer hospital stay and slow recovery. Unfortunately, there have been no specific guidelines for hybrid therapy for PAD, and this will require further investigation.
      The main findings of previous studies were that the number of infrapopliteal arterial runoff vessels is crucial in determining the clinical outcomes after the recanalization of CTO.
      • Park U.J.
      • Kim H.T.
      • Roh Y.N.
      Impact of tibial runoff on outcomes of endovascular treatment for femoropopliteal atherosclerotic lesions.
      ,
      • Davies M.G.
      • Saad W.E.
      • Peden E.K.
      • et al.
      Percutaneous superficial femoral artery interventions for claudication--does runoff matter?.
      Therefore, we attempted to enrol patients with more runoff vessels below the knee, to obtain a good long-term clinical result. We found that interventions in cases with 2 or 3 run-off vessels had a better outcome than in cases with 1 runoff vessel, similar to the findings of previous studies.
      • Guo X.
      • Xue G.
      • Huang X.
      • et al.
      Outcomes of endovascular treatment for patients with TASC II D femoropopliteal occlusive disease: a single center study.
      ,
      • Lazaris A.M.
      • Salas C.
      • Tsiamis A.C.
      • et al.
      Factors affecting patency of subintimal infrainguinal angioplasty in patients with critical lower limb ischemia.
      However, few studies have investigated whether the number of run-off vessels is a risk factor for restenosis or occlusion, and we only included 25 such cases in our study.
      No covered stents were used in the primary EVT in our study, as we consider that these should only be used in patients with in-stent restenosis or occlusion due to myointimal hyperplasia. It has been reported that in-stent restenosis or occlusion was the main drawback after EVT, with an incidence of 40–50%, and that the most common site is in the femoral popliteal artery.
      • Banerjee S.
      • Sarode K.
      • Mohammad A.
      • et al.
      Femoropopliteal artery stent thrombosis: report from the excellence in peripheral artery disease registry.
      In this study, 23.2% (13/56) patients developed in-stent reocclusion. Furthermore, our study confirmed that a longer lesion could increase the occurrent rate of restenosis or occlusion.
      In this study, most of the patients were aged more than 60 years (87.0%, 47/54) with poly-vascular disease and the incidence of cardiovascular and cerebrovascular events during the perioperative period was high (5.6%; 3/54). The ulcer healing rate was 93.8% (15/16) after EVT. CLI was a risk factor for amputation and fatal vascular events. During the follow-up in this study, 15 amputations were performed. The patients included in this study had similar demographics and atherosclerotic risk factors with CLI, while other studies included a significant number of patients suffering from intermittent claudication and rest pain. This difference in the indication for EVT likely had a detrimental effect on the limb salvage rates.
      The amputation rate in patients with gangrene in this study was 86.7% (13/15). Due to the small number of cases in this group, the risk factors affecting the ulcer healing rate and limb salvage rate were not statistically analysed and the relevant literature also did not draw a firm conclusion.

      Study Limitations

      Our study had important limitations. First, this was a retrospective observational study involving a small cohort and the risk of all sorts of bias and confounding is substantial, which limited external validity of any finding or conclusion. Second, we were unable to account for the effectiveness of endovascular or surgical revascularization procedures because there was no comparison with surgical bypass in our study. Future studies are required to establish if the good results achieved by EVT last in the long-term.

      Conclusion

      In this single-centre, retrospective study, the midterm follow-up outcomes of EVT for TASC II D femoropopliteal lesions with CLI were safe and satisfactory. These results strengthened those of other already published studies in confirming that this patient subset would benefit from a minimally invasive EVT. We consider that EVT could be the main treatment for femoropopliteal TASC II D lesions. Our study showed that this approach can result in clinical improvement with abolition of rest pain and wound healing for ulcers and gangrene, with quite impressive results. However, further prospective randomized trials providing a higher level of evidence are needed to determine whether EVT should be considered as first-choice treatment for TASC II D femoropopliteal lesions.

      Supplementary Data

      References

        • Aronow W.S.
        Peripheral arterial disease of the lower extremities.
        Arch Med Sci. 2012; 8: 375-388
        • Kinlay S.
        Management of critical limb ischemia.
        Circ Cardiovasc Interv. 2016; 9: e001946
        • Norgren L.
        • Hiatt W.R.
        • Dormandy J.A.
        • et al.
        Inter-society Consensus for the management of peripheral arterial disease (TASC II).
        Eur J Vasc Endovasc Surg. 2007; 33: S1-S75
        • Stoner M.C.
        • Calligaro K.D.
        • Chaer R.A.
        • et al.
        Society for Vascular Surgery. Reporting standards of the Society for Vascular Surgery for endovascular treatment of chronic lower extremity peripheral artery disease.
        J Vasc Surg. 2016; 64: e1-e21
        • Biagioni R.B.
        • Brandão G.D.
        • Biagioni L.C.
        • et al.
        Endovascular treatment of TransAtlantic Inter-Society Consensus II D femoropopliteal lesions in patients with critical limb ischemia.
        J Vasc Surg. 2019; 69: 1510-1518
        • Patel S.D.
        • Biasi L.
        • Paraskevopoulos I.
        • et al.
        Comparison of angioplasty and bypass surgery for critical limb ischaemia in patients with infrapopliteal peripheral artery disease.
        Br J Surg. 2016; 103: 1815-1822
        • Bracale U.M.
        • Giribono A.M.
        • Spinelli D.
        • et al.
        Long-term results of endovascular treatment of TASC C and D aortoiliac occlusive disease with expanded polytetrafluoroethylene stent graft.
        Ann Vasc Surg. 2019; 56: 254-260
        • Bosiers M.
        • Setacci C.
        • De Donato G.
        • et al.
        ZILVERPASS study: ZILVER PTX stent vs bypass surgery in femoropopliteal lesions.
        J Endovasc Ther. 2020; 27: 287-295
        • Fowkes F.G.
        • Murray G.D.
        • Butcher I.
        • et al.
        • Ankle Brachial Index Collaboration
        Ankle brachial index combined with Framingham Risk Score to predict cardiovascular events and mortality: a meta-analysis.
        JAMA. 2008; 300: 197-208
        • Rutherford R.B.
        • Baker J.D.
        • Ernst C.
        • et al.
        Recommended standards for reports dealing with lower extremity ischemia: revised version.
        J Vasc Surg. 1997; 26: 517-538
        • Katsanos K.
        • Tepe G.
        • Tsetis D.
        • et al.
        Standards of practice for superficial femoral and popliteal artery angioplasty and stenting.
        Cardiovasc Intervent Radiol. 2014; 37: 592-603
        • Veraldi G.F.
        • Mezzetto L.
        • Macrì M.
        • et al.
        Comparison of endovascular versus bypass surgery in femoropopliteal TASC II D lesions: a single-center study.
        Ann Vasc Surg. 2018; 47: 179-187
        • Meyer A.
        • Lang W.
        • Borowski M.
        • et al.
        • CRITISCH collaborators
        In-hospital outcomes in patients with critical limb ischemia and end-stage renal disease after revascularization.
        J Vasc Surg. 2016; 63: 966-973
        • Guo X.
        • Xue G.
        • Huang X.
        • et al.
        Outcomes of endovascular treatment for patients with TASC II D femoropopliteal occlusive disease: a single center study.
        BMC Cardiovasc Disord. 2015; 15: 44
        • Kedora J.
        • Hohmann S.
        • Garrett W.
        • et al.
        Randomized comparison of percutaneous Viabahn stent grafts vs prosthetic femoral-popliteal bypass in the treatment of superficial femoral arterial occlusive disease.
        J Vasc Surg. 2007; 45: 10-16
        • Brouillet J.
        • Deloose K.
        • Goueffic Y.
        • et al.
        Primary stenting for TASC C and D femoropopliteal lesions: one-year results from a multicentric trial on 203 patients.
        J Cardiovasc Surg (Torino). 2018; 59: 392-404
        • Acin F.
        • de Haro J.
        • Bleda S.
        • et al.
        Primary nitinol stenting in femoropopliteal occlusive disease: a meta-analysis of randomized controlled trials.
        J Endovasc Ther. 2012; 19: 585-595
        • Elmahdy M.F.
        • Buonamici P.
        • Trapani M.
        • et al.
        Long-term primary patency rate after nitinol self-expandable stents implantation in long, totally occluded femoropopliteal (TASC II C & D) lesions.
        Heart Lung Circ. 2017; 26: 604-611
        • Rocha-Singh K.J.
        • Jaff M.R.
        • Crabtree T.R.
        • et al.
        VIVA Physicians, Inc. Performance goals and endpoint assessments for clinical trials of femoropopliteal bare nitinol stents in patients with symptomatic peripheral arterial disease.
        Catheter Cardiovasc Interv. 2007; 69: 910-919
        • Hartung O.
        • Otero A.
        • Dubuc M.
        • et al.
        Efficacy of Hemobahn in the treatment of superficial femoral artery lesions in patients with acute or critical ischemia: a comparative study with claudicants.
        Eur J Vasc Endovasc Surg. 2005; 30: 300-306
        • Murakami A.
        Hybrid operations in patients with peripheral arterial disease.
        Ann Vasc Dis. 2018; 11: 57-65
        • Kang J.L.
        • Patel V.I.
        • Conrad M.F.
        • et al.
        Common femoral artery occlusive disease: contemporary results following surgical endarterectomy.
        J Vasc Surg. 2008; 48: 872-877
        • Park U.J.
        • Kim H.T.
        • Roh Y.N.
        Impact of tibial runoff on outcomes of endovascular treatment for femoropopliteal atherosclerotic lesions.
        Vasc Endovascular Surg. 2018; 52: 498-504
        • Davies M.G.
        • Saad W.E.
        • Peden E.K.
        • et al.
        Percutaneous superficial femoral artery interventions for claudication--does runoff matter?.
        Ann Vasc Surg. 2008; 22: 790-798
        • Lazaris A.M.
        • Salas C.
        • Tsiamis A.C.
        • et al.
        Factors affecting patency of subintimal infrainguinal angioplasty in patients with critical lower limb ischemia.
        Eur J Vasc Endovasc Surg. 2006; 32: 668-674
        • Banerjee S.
        • Sarode K.
        • Mohammad A.
        • et al.
        Femoropopliteal artery stent thrombosis: report from the excellence in peripheral artery disease registry.
        Circ Cardiovasc Interv. 2016; 9: e002730