|Year : 2019 | Volume
| Issue : 4 | Page : 256-261
Early and mid-term results of surgical and endovascular intervention in total occlusion of superficial femoral artery: Which one is better?
Mihriban Yalcin1, Osman Tiryakioglu2
1 Department of Cardiovascular Surgery, Ordu State Hospital, Ordu, Turkey
2 Department of Cardiovascular Surgery, Private Medicalpark Hospital, Bursa, Turkey
|Date of Submission||12-Jun-2019|
|Date of Decision||13-Oct-2019|
|Date of Acceptance||21-Oct-2019|
|Date of Web Publication||20-Dec-2019|
Dr. Mihriban Yalcin
Department of Cardiovascular Surgery, Ordu State Hospital, Ordu
Source of Support: None, Conflict of Interest: None
Objectives: Lower extremity peripheral artery disease is a common and important type of systemic atherosclerosis. The purpose of this study is to compare safety and effectiveness of balloon angioplasty, primary stenting and femoropopliteal bypass to treat total superficial femoral artery (SFA) lesions. Methods: 181 consecutive limbs from 149 patients who underwent endovascularly or surgically infrainguinal interventions between June 2013 and June 2017 were included in this retrospective study. Seventy-four legs (40.2%) underwent femoropopliteal bypass surgery, 58 legs (31.5%) were treated with balloon angioplasty, and nitinol stents were used in 49 (23.9%) legs. Results: A total of 149 patients were treated; surgically 56 patients and endovascularly 45 + 40 patients. The mean follow-up time was 24 months (range 4–56 months). The patency rates were 86.7% in the angioplasty group, 82.5% in the stent group, and 94.6% in the bypass group at the end of 24 months (P = 0.159). The rate of reintervention was three patients in the bypass group, six patients in the angioplasty group, and seven patients in the stent group (P = 0.159). The mean reintervention time in bypass was 52.075 months, 43.467 months in balloon angioplasty, and 44.075 months in stent group. Conclusions: There was no significant difference between groups in terms of reintervention and patency rates.
Keywords: Balloon angioplasty, femoropopliteal bypass, reintervention, stent
|How to cite this article:|
Yalcin M, Tiryakioglu O. Early and mid-term results of surgical and endovascular intervention in total occlusion of superficial femoral artery: Which one is better?. Indian J Vasc Endovasc Surg 2019;6:256-61
|How to cite this URL:|
Yalcin M, Tiryakioglu O. Early and mid-term results of surgical and endovascular intervention in total occlusion of superficial femoral artery: Which one is better?. Indian J Vasc Endovasc Surg [serial online] 2019 [cited 2020 Feb 20];6:256-61. Available from: http://www.indjvascsurg.org/text.asp?2019/6/4/256/273595
| Introduction|| |
After myocardial infarction and stroke, peripheral artery disease (PAD) is the third cause of cardiovascular morbidity and its prevalence increases with age. More than 25% of the adult population over 65 years have PAD. Lower extremity arterial disease often affects the femoropopliteal segment and reduces the quality of life and is the common cause of lower limb amputation so must be treated. People with PAD may be asymptomatic, or have intermittent claudication, chronic critical limb ischemia or acute critical limb ischemia and more than 50% of cases of claudication are caused by chronic total occlusion (CTO) of the superficial femoral artery (SFA). CTO in the peripheral artery often encountered during treatment and evaluation of patients with symptomatic PAD. Total occlusions are longer lesions and three times more common than stenotic lesions. Stenoses or occlusions in the SFA can be treated even stenting or by balloon angioplasty or surgery.
This is a retrospective analysis of consecutive patients who had undergone prosthetic above-the-knee femoropopliteal bypass or percutaneous transluminal angioplasty (PTA) or stenting of total SFA occlusion at a single center between June 2013 and June 2017.
| Methods|| |
We analyzed 184 consecutive limbs in 149 patients who underwent endovascularly or surgically infrainguinal interventions between June 2013 and June 2017 in this retrospective study. Patients were divided into three treatment groups; Group 1 went surgical bypass, Group 2 had balloon angioplasty alone, and Group 3 had balloon angioplasty with stent placement.
24 months results were compared in terms of complications, patency and reintervention rates in both groups. We obtained data for all interventions and hospital stays during follow-up. Demographic features, comorbidities, indications for intervention and revision, operative data and immediate postoperative outcomes were collected retrospectively. Age, gender, diabetes mellitus (DM), hyperlipidemia, hypertension, smoking, coronary artery disease, respiratory disease, cerebrovascular disease, and chronic renal failure are the parameters looked for patients.
Patients evaluated with physical examinations. All symptomatic patients underwent noninvasive arterial Doppler studies. After the clinical examination, the approach was planned with peripheral magnetic resonance angiography in 89 (59.7%) patients and remaining 60 (40.3%) patients with digital subtraction angiography (DSA). According to patients status, symptoms, and angiogram findings the treatment decision gaved by surgeon and patient. The patients with extensive lesions >20 cm were offered bypass surgery. For lesions <20 cm long and for patients who refused bypass surgery, the treatment is PTA. The short and midline SFA lesions were treated with stents (after PTA if residual stenosis is >30% then stents were used).
All patients gave written informed consent before undergoing the procedure. The study was retrospective and did not need approval of the local ethics committee.
- Technical success rate
- Vessel patency rate.
- Complications (groin hematoma, vessel rupture or perforation, vessel wall dissection, distal embolism, renal failure, and cerebrovascular event)
The inclusion criteria were; totally SFA occlusion and informed consent. Acute critical limb ischemia, previous bypass surgery or stenting, and known intolerance to contrast agents are the exclusion criteria. We performed uncommon percutaneous interventions such as atherectomy in 8 patients. These consisted of SFA distal section patients who had previously been treated and failed. And, they were excluded of work.
Femoral to above-knee popliteal artery bypass was performed under spinal anesthesia with autologous vein or if not appropriate synthetic conduits (Dacron or ePTFE). All endovascular procedures were performed under local anesthesia. Antegrade ipsilateral or retrograde contralateral femoral approach in intraluminal or subintimal recanalization of the vessel lumen are used for SFA occlusions. If there is ostial SFA occlusion contralateral puncture was applied. A 6-F sheath was placed and 5000 IU of heparin was administered. An angiogram was made and the length of the target session was measured by using a radiopaque ruler. PTA was performed using 4–6 mm diameter and appropriate length balloons. After PTA if residual stenosis is >30% then stents were used. Stent diameter was determined to oversize the original vessel diameter by approximately 1 mm. In all cases, self-expanding nitinol stents were used. The final angiogram documented normal flow in the stented lesions.
The average follow-up was 24 months (range 4–56 months).
After the procedure, all patients received clopidogrel (75 mg daily) for 3 months and acetylsalicylic acid (100 mg daily) for long life. Cilostazol was advised for patients to improve walking distance.
Bypass thrombosis, restenosis of >50% of the treated arterial segment, intragraft restenosis >50%, are the indicators of graft failure. Restenosis was defined as diameter reduction >50% in the segment and reintervention was performed. Bleeding and hematomas were identified as major if transfusion or surgical treatment required.
Clinical follow-up were performed at 3, 6, and 12 months and then annually (symptoms, inspection of the limb, pulse palpation, ultrasonographic evaluation, and X-ray for stent fracture).
The recorded data were patency of femoropopliteal segment, restenosis degree, and procedural complications (development of renal failure, reaction to contrast, local groin complications) and stent fracture.
The data obtained from the study were analyzed using Statistical Package for the Social Sciences for Windows 22.0 program (SPSS, Chicago, IL, USA). Number, percentage, mean, and standard deviation were used as descriptive statistical methods for the evaluation of the data. One-way ANOVA test was used to compare quantitative continuous data between more than two independent groups. Scheffe's test was used as complementary post hoc analysis to determine the differences after the ANOVA test. The relationship between group variables was tested by Chi-square analysis. Kaplan–Meier survival analysis was used for reintervention times. P <0.05 was considered significant for all analysis.
| Results|| |
One hundred and forty-one patients were included in the study: of these, 38 (27%) were female and 103 (73%) were male. The total number of limbs processed was calculated as 181. Fifty-eight limbs in 45 patients were treated percutaneously with angioplasty alone and 49 limbs in 40 patients with the stent, and 74 limbs in 56 patients were treated surgically with femoral above-knee popliteal artery bypass.
Demographic data, risk factors, and comorbidities are shown in [Table 1]. There was no statistically significant difference between the characteristics of the groups.
The mean age of the balloon angioplasty group (x̄ = 68.2) was also significantly higher than the bypass group (x̄ = 61.2) and the stent group (x̄ = 63.2) (P ≤ 0.001).
Risk factors were similar in both groups. The most common preexisting risk factors were: smoking, 91% (135 patients); DM 84.5% (126 patients); and hyperlipidemia, 64.4% (96 patients). All patients had lifestyle-limiting symptoms. Intermittent claudication in the calf and leg in that extremity was the predominant symptom of people [Table 2]. The mean ankle brachial index in claudicants was 0.64 + 0.12 and 0.46 ± 0.10 in patients with symptom of rest pain.
The length of the occlusion according to the groups showed significant difference (P ≤ 0.001). The mean of the occlusion of the bypass group (x̄ = 24.0) is higher than the balloon angioplasty group (x̄ = 16.2) and the stent group (x̄ = 14.4). And, the balloon angioplasty group has a higher occlusion length (x̄ = 16.2) than the stent group (x̄ = 14.4) [Table 3].
Drug eluting balloon angioplasty was performed in 45 (30.2%) patients and in the 58 (31.5%) limb. These patients were with total occlusion extending to the popliteal artery. 40 (26.8%) patients with total occlusion were treated with stent. None of the patients who underwent balloon angioplasty and stent had a second procedure at the duration of hospital stay. A hematoma that was visible but clinically insignificant on the leg was observed in a patient who underwent balloon angioplasty.
Femoropopliteal bypass was performed in patients with total occlusion and obstruction from the distinction of deep femoral artery to hunter canal exit. The number of patients undergoing bypass was 56 (37.6%) and the number of limbs was 74 (40.2%). Bypass was performed bilaterally in 19 patients under spinal anesthesia in the same session. Femoropopliteal bypass was successfully performed in 100% of limbs in the surgical group. In the bypass group, bleeding revision was performed in four patients and thrombectomy was performed in one patient in the early postoperative period.
There was one access-related complication which was a hematoma around the access site, and no pseudoaneurysm or arteriovenous fistulas and no stent fracture were seen at follow-up. No major amputations were performed on limbs undergoing SFA intervention, only a digital amputation was seen in bypass group. No patients were lost to follow-up.
A total of 14 (7.6%) patients were retreated in the follow-up period. Three of these patients were bypass, 6 were balloon angioplasty, and 7 were stent. Patients, who underwent bypass surgery, underwent thrombectomy due to obstruction. Secondary patency is still ongoing. In six patients who underwent balloon angioplasty and recladiculation, five patients underwent repeat balloon angioplasty and in one patient patency was provided by self-expandable stent. Balloon angioplasty was applied to five of seven patients who presented with stent thrombosis and occlusion, and two patients underwent restent application. There was no significant relationship between the groups with respect to reintervention (χ2 = 3.6; P = 0.159 > 0.05) [Table 3].
Patency rates at the end of 2 years were similar in both groups: (86.7% in the balloon angioplasty group, 82.5% in the stent group, and 94.6% in the bypass group) (P = 0.159). There was no significant difference between groups in terms of patency rates [Figure 1].
The mean reintervention time in bypass was 52.075 months, 43.467 months in balloon angioplasty, and 44.075 months in stent group [Table 4] and [Figure 2].
| Discussion|| |
The treatment of the patient with chronic lower extremity ischemia consist of atherosclerotic risk factor modification and exercise regimens, and specific interventions targeting symptom relief and limb salvage.
The use of antiplatelet agents, exercise regimens, and vasodilators therapy are conservative treatment options. PTA, stent implantation, and surgical procedures such as bypass and endarterectomy are treatment choices. There is not enough evidence to prove the superiority of one method over the other. Exercise therapy and medical therapy are initial therapies for people with claudication, but if rest pain and tissue loss is present, early intervention is recommended.
Less invasive, low procedural morbidity and mortality are the advantages of balloon angioplasty/stenting, late clinical failure due to restenosis or arterial occlusion are the limitations of percutaneous catheter-based interventions., Bypass surgery has demonstrated clinical effect and long-term results, especially as expressed by patency levels in complex femoral popliteal disease.
Endovascular treatment has three basic problems in the treatment of totally occluded lesions: (1) challenges in wire passage, (2) entry into the lumen, and (3) ensuring long-term patency. The technical success rate for PTA for stenotic and occlusive lesions has published over 95%, but late clinical failure remains an important problem. In our study. After 2 years, patency rate decreased to 86.7% in the angioplasty alone group and 82.5% in the stent group. The mean reintervention time was 43.467 months in balloon angioplasty and 44.075 months in stent group.
After PTA for femoropopliteal occlusive disease patency rates are between 56% and 70% at 1 year., We found our patency rates higher at the end of 2 years. It may be because of the low mean length of occlusions in SFA. The mean length of occlusions in the SFA was 20–40 cm. In our study, it was 24 cm for bypass, 16 cm for balloon, and 14 cm for stent.
For management of longer lesions, nitinol stents may be an effective alternative to surgical revascularization because their patency rates are likely to prosthetic bypass grafts and stenting has significantly lower complication rate. Astarcioglu et al. found that the cumulative primary patency and secondary patency rate at 12 months were 63.9% and 82.1%, respectively, which is similar previously reported findings., We found our patency rates in the stent group 82.5% and 94.6% in the bypass group at the end of 2 years. There was no significantly difference (P = 0.159)
Nitinol stent use seems to be an encouraging strategy, but stent fractures and clinical outcomes are accepted increasingly. In the literature, the incidence of stent fracture ranges from 2% to 65%. In our study, we have no stent fractures in the time of 2 years. Instent restenosis (ISR) still remains a significant disadvantage of stents. In our study, there were seven patients with ISR. Five of them went balloon angioplasty and 2 of them restented.
In two randomized controlled trials, results of balloon angioplasty were like primary nitinol stent implantation., In our study, the primary patency was 86.7% in the angioplasty alone group and 82.5% in the stent group. There was no significant difference.
Diabetes, age >80 years, and renal failure are bad predictors for both endovascular and open surgical revascularization. In our study, DM was seen in the 84.5% (126 patients) of patients and renal failure was in the 16.3% (23 patients). The mean age of our patients was 61.2 in the bypass group, 68.2 in the balloon angioplasty group, and 63.2 in the stent group.
Islam and Robbs reported that between three methods (surgical bypass, balloon angioplasty, and stenting), none is superior to the other. Mwipatayi et al. reported that in the femoropopliteal occlusive disease when compared with angioplasty, stent placement does not increase the patency rate and Nguyen et al. found similar results with stenting and balloon angioplasty alone, but Laird et al. reported better results and patency rates with self-expanding nitinol stents. In our study we found similar results too. However, the occlusion length was significantly smaller in stent group; its patency rate was lower than angioplasty group (86.7% vs. 82.5%) and reintervention rates were higher (13.3% vs. 17.5%). However, there is no statistically significant difference.
Malas et al. reported better primary patency for the stent group (67%) compared with bypass group (49%) and higher reintervention rates were in bypass group at 2 years. Our results are opposite to this. Bypass patency rates and reintervention rates are better than stent group. The mean reintervention time in bypass was 52.075 months and 44.075 months in stent group. Although the results seem to favor the bypass, there is no statistically significant difference.
In the surgery era, McQuade et al. reported similar primary patency at 4-year (48 months) follow-up between percutaneous stent grafts and conventional femoral-popliteal artery bypass grafting with synthetic conduit. In our study, at 2 years, bypass patency rates are higher than both angioplasty alone and stent groups. Our study was for 2-years follow-up. The average length of the treated lesions was lower in our study. Hence, these may explain the high patency rates.
The study has several limitations. This was a retrospective study and was performed in only in one center and by a team; hence, the population size was small and has short duration of follow-up.
| Conclusions|| |
Total SFA occlusions have low reintervention rates. There was no significant difference between groups in terms of reintervention and patency rates. To achieve this, it is necessary to determine the SFA lesions and their lengths in the preoperative period and to apply the correct method accordingly. The lesion morphology, location, and patient's symptoms can be thought to decide treatment.
Further randomized controlled studies evaluate surgical results and endovascular treatment is necessary for the treatment of femoropopliteal arterial disease. Current pharmacotherapy and advances in stent and catheter technology will improve outcomes. However, it should be kept in mind that bypass is still a good option.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
| References|| |
Fowkes FG, Rudan D, Rudan I, Aboyans V, Denenberg JO, McDermott MM, et al.
Comparison of global estimates of prevalence and risk factors for peripheral artery disease in 2000 and 2010: A systematic review and analysis. Lancet 2013;382:1329-40.
Zeller T, Saratzis N, Scheinert D, Minar E, Beregi JP, Schillinger M, et al.
Non-randomized, prospective, multi-centre evaluation of the ABSOLUTE.035 peripheral self-expanding stent system for occluded or stenotic superficial femoral or proximal popliteal arteries (ASSESS trial): Acute and 30-day results. J Cardiovasc Surg (Torino) 2007;48:719-26.
Nadal LL, Cynamon J, Lipsitz EC, Bolia A. Subintimal angioplasty for chronic arterial occlusions. Tech Vasc Interv Radiol 2004;7:16-22.
Rogers JH, Laird JR. Overview of new technologies for lower extremity revascularization. Circulation 2007;116:2072-85.
Chopra P. Use of the VIABAHN® Stent Graft for PVD in the Femoropopliteal Arterial Segment. One Center's Experience in 60 Patients. Achieving Success in the SFA. Supplement to Endovascular Today; 2005. p. 4-7.
Gandhi S, Weinberg I, Margey R, Jaff MR. Comprehensive medical management of peripheral arterial disease. Prog Cardiovasc Dis 2011;54:2-13.
National Institute for Health and Clinical Excellence. Lower Limb Peripheral Arterial Disease: Diagnosis and Management. National Clinical Guideline Centre Lower Limb Peripheral Arterial Disease: Diagnosis and Management. London: Royal College of Physicians (UK); 2012. Available from: http://www.nice.org.uk/nicemedia/live/13856/60428/60428.pdf
. [Last accessed on 2014 May 16].
Gandhi S, Sakhuja R, Slovut DP. Recent advances in percutaneous management of iliofemoral and superficial femoral artery disease. Cardiol Clin 2011;29:381-94.
Lin PH, Weakley SM, Kougias P. How to interpret data from the superficial femoral artery stenting trials and registries. Semin Vasc Surg 2010;23:138-47.
Burns P, Gough S, Bradbury AW. Management of peripheral arterial disease in primary care. BMJ 2003;326:584-8.
Duda SH, Bosiers M, Lammer J, Scheinert D, Zeller T, Oliva V, et al.
Drug-eluting and bare nitinol stents for the treatment of atherosclerotic lesions in the superficial femoral artery: Long-term results from the SIROCCO trial. J Endovasc Ther 2006;13:701-10.
Setacci C, Chisci E, de Donato G, Setacci F, Iacoponi F, Galzerano G. Subintimal angioplasty with the aid of a re-entry device for TASC C and D lesions of the SFA. Eur J Vasc Endovasc Surg 2009;38:76-87.
Myers SI, Myers DJ, Ahmend A, Ramakrishnan V. Preliminary results of subintimal angioplasty for limb salvage in lower extremities with severe chronic ischemia and limb-threatening ischemia. J Vasc Surg 2006;44:1239-46.
Lammer J, Zeller T, Hausegger KA, Schaefer PJ, Gschwendtner M, Mueller-Huelsbeck S, et al.
Heparin-bonded covered stents versus bare-metal stents for complex femoropopliteal artery lesions: The randomized VIASTAR trial (Viabahn endoprosthesis with PROPATEN bioactive surface [VIA] versus bare nitinol stent in the treatment of long lesions in superficial femoral artery occlusive disease). J Am Coll Cardiol 2013;62:1320-7.
Astarcioglu MA, Kilit C, Sen T, Durmus HI, Kalcik M, Gursoy MO. One-year results of primary stenting for TASC II D lesions of the superficial femoral and popliteal arteries. Acta Cardiol 2017;72:36-40.
Treiman GS, Treiman R, Whiting J. Results of percutaneous subintimal angioplasty using routine stenting. J Vasc Surg 2006;43:513-9.
Scheinert D, Scheinert S, Sax J, Piorkowski C, Bräunlich S, Ulrich M, et al.
Prevalence and clinical impact of stent fractures after femoropopliteal stenting. J Am Coll Cardiol 2005;45:312-5.
Adlakha S, Sheikh M, Wu J, Burket MW, Pandya U, Colyer W, et al.
Stent fracture in the coronary and peripheral arteries. J Interv Cardiol 2010;23:411-9.
Dake MD, Ansel GM, Jaff MR, Ohki T, Saxon RR, Smouse HB, et al.
Paclitaxel-eluting stents show superiority to balloon angioplasty and bare metal stents in femoropopliteal disease: Twelve-month zilver PTX randomized study results. Circ Cardiovasc Interv 2011;4:495-504.
Laird JR, Katzen BT, Scheinert D, Lammer J, Carpenter J, Buchbinder M, et al.
Nitinol stent implantation versus balloon angioplasty for lesions in the superficial femoral artery and proximal popliteal artery: Twelve-month results from the RESILIENT randomized trial. Circ Cardiovasc Interv 2010;3:267-76.
Vainio E, Salenius JP, Lepäntalo M, Luther M, Ylönen K. Endovascular surgery for chronic limb ischaemia. Factors predicting immediate outcome on the basis of a nationwide vascular registry. Ann Chir Gynaecol 2001;90:86-91.
Islam J, Robbs JV. Comparison between superficial femoral artery stenting and bypass surgery in severe lower-limb ischaemia: A retrospective study. Cardiovasc J Afr 2015;26:34-7.
Mwipatayi BP, Hockings A, Hofmann M, Garbowski M, Sieunarine K. Balloon angioplasty compared with stenting for treatment of femoropopliteal occlusive disease: A meta-analysis. J Vasc Surg 2008;47:461-9.
Nguyen BN, Conrad MF, Guest JM, Hackney L, Patel VI, Kwolek CJ, et al.
Late outcomes of balloon angioplasty and angioplasty with selective stenting for superficial femoral-popliteal disease are equivalent. J Vasc Surg 2011;54:1051-70.
Malas MB, Enwerem N, Qazi U, Brown B, Schneider EB, Reifsnyder T, et al.
Comparison of surgical bypass with angioplasty and stenting of superficial femoral artery disease. J Vasc Surg 2014;59:129-35.
McQuade K, Gable D, Pearl G, Theune B, Black S. Four-year randomized prospective comparison of percutaneous ePTFE/nitinol self-expanding stent graft versus prosthetic femoral-popliteal bypass in the treatment of superficial femoral artery occlusive disease. J Vasc Surg 2010;52:584-90.
[Figure 1], [Figure 2]
[Table 1], [Table 2], [Table 3], [Table 4]