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 Table of Contents  
ORIGINAL ARTICLE
Year : 2020  |  Volume : 33  |  Issue : 2  |  Page : 706-712

Factors affecting the outcome of superficial femoral artery stenting


1 Departments of Surgery, Faculty of Medicine, Menoufia University, Menoufia, Egypt
2 Departments of Vascular Surgery, Faculty of Medicine, Menoufia University, Menoufia, Egypt

Date of Submission14-Dec-2019
Date of Decision05-Feb-2020
Date of Acceptance08-Feb-2020
Date of Web Publication27-Jun-2020

Correspondence Address:
Mohammed S. Ahmed Abd Allah
Department of Vascular Surgery, Faculty of Medicine, Menoufia University, Menoufia
Egypt
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/mmj.mmj_376_19

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  Abstract 


Objectives
The aim of this study was to assess the durability of superficial femoral artery stents and factors that affect stent patency.
Patients and methods
This prospective study was carried out on 30 patients who were complaining of critical limb ischemia (CLI). CLI was recorded in 22 right lower limbs and in 11 left lower limbs.
Results
There was a significant correlation between the occurrenace of CLI and diabetes mellitus (P = 0.001), hypertension (P = 0.011), ischemic heart disease (P = 0.028), chronic renal failure (P = 0.001), and cerebrovascular disease (P = 0.001). In all, 59% of lesions treated were chronic total occlusions and the remaining 41% were for stenotic lesions. Trans-Atlantic Inter-Society Consensus (TASC) II A group lesions were found in 11 (33.3%) limbs; TASC II B group lesions were found in 13 (39.4%) limbs; TASC II C group lesions were found in five (15.2%) limbs; and TASC II C or D group lesions were found in four (12.1%) limbs. There was a significant (P = 0.001) decrease of primary and secondary patency in smokers and in diabetic patients.
Conclusion
Diabetes mellitus, hypertension, ischemic heart disease, chronic renal failure, and cerebrovascular diseases are risk factors for the occurrence of CLI.

Keywords: atherosclerosis, outcomes, patency, risk factors, stenting, superficial femoral artery


How to cite this article:
Abd Allah MS, Abu Grida HS, Mohammed AmF, Al Khateep YM. Factors affecting the outcome of superficial femoral artery stenting. Menoufia Med J 2020;33:706-12

How to cite this URL:
Abd Allah MS, Abu Grida HS, Mohammed AmF, Al Khateep YM. Factors affecting the outcome of superficial femoral artery stenting. Menoufia Med J [serial online] 2020 [cited 2020 Oct 26];33:706-12. Available from: http://www.mmj.eg.net/text.asp?2020/33/2/706/287790




  Introduction Top


Peripheral arterial disease (PAD) is a nearly pandemic condition that has the potential to cause loss of limb or even loss of life. PAD manifests as insufficient tissue perfusion initiated by existing atherosclerosis acutely compounded by either emboli or thrombi. Many people live daily with significant degrees of PAD; however, in settings such as acute limb ischemia, this latent disease can suddenly become life threatening and can necessitate emergency intervention to minimize morbidity and mortality[1].

PAD of the superficial femoral artery (SFA) is the most common cause of intermittent claudication (IC). Atherosclerotic disease of the SFA is localized to the region of Hunter's canal. An isolated occlusion or stenosis of the SFA often results in decreased perfusion of the leg, resulting in demand-related, reversible, ischemic pain localized to the calf. Ischemic rest pain and tissue loss, also known as critical limb ischemia (CLI), are uncommon manifestations of isolated SFA disease. CLI is more commonly observed when occlusive disease of the SFA is combined with occlusive disease involving the below-the-knee popliteal artery or tibial arteries[2].

Atherosclerosis is a systemic disease of the large-sized and medium-sized arteries causing luminal narrowing (focal or diffuse) as a result of the accumulation of lipid and fibrous material between the intimal and medial layers of the vessel. Atherosclerosis of the noncardiac vessels is defined as the PAD. An ankle–brachial index (ABI) less than or equal to 0.90 is sensitive and specific for arterial stenosis/occlusion and diagnostic for PAD[3].

An epidemiologic model based on a systematic review of the prevalence of PAD (defined as an ABI ≤0.90) around the world was used to compare predicted PAD prevalence in three high-income and five low-income/middle-income WHO regions[4]. Smoking, diabetes, hypertension, and hypercholesterolemia were important risk factors in high-income and low/middle-income regions. Sex-specific prevalence increased with the age for both sexes[4].

Clinical manifestations of PAD (claudication, rest pain, ulceration, and gangrene) are predominantly due to progressive luminal narrowing (stenosis/occlusion), although thrombosis or embolism of unstable atherosclerotic plaque or thrombotic material can also occur[5]. The natural history of those who present with mild-to-moderate claudication is generally benign, which contrasts with the more aggressive presentation seen in those who present with ischemic rest pain or ulceration. Exertional pain in patients with lower extremity PAD is termed 'claudication,' which is derived from the Latin word 'claudico' (to limp). Claudication is a reproducible discomfort of a defined group of muscles that is induced by exercise and relieved with rest. Claudication can present unilaterally or bilaterally, as pain in the buttocks and hip, thigh, calf, or the foot, singly or in combination. Severity of symptoms depends on the number and degree of arterial narrowing, collateral circulation, and the vigor of extremity use[5].

Limb-threatening ischemia presents as ischemic pain, tissue loss, or both. The nature of these manifestations depends on the time course over which arterial narrowing or occlusion occurs; this in turn affects the extent to which collateral circulation can develop. Acute reductions in limb perfusion, which may be due to atheroembolism, cholesterol embolism, or thrombotic occlusion of a stenotic vessel, cause diffuse limb pain[6]. Chronic severe reductions in limb perfusion present as ischemic rest pain, typically localized to the forefoot and toes, or as tissue loss (nonhealing ulcer, gangrene). The aim of this study was to assess the durability of SFA stents and factors that affect stent patency.


  Patients and Methods Top


Ethical approval and consent was taken. This study was carried out in the Department of Surgery – Vascular Surgery, Faculty of Medicine, Menoufia University, Menoufia, Egypt.

Patients

This prospective study was carried out in the Vascular Surgery Department, Menoufia University Hospitals during the period from January 2016 to December 2018, on 30 patients complained of CLI. The procedure, possible complications, benefits, risks, and other alternative interventions were all explained to the patients and an informed consent was obtained. The inclusion criteria were patients presented with CLI having SFA lesions treated with placement of single stent or multiple stents. However, the exclusion criteria were incomplete follow-up data, other causes for SFA lesions like aneurysmal disease, and vasculitis.

Investigations

Routine laboratory test results were collected from the files including the complete blood picture, kidney and liver function tests, coagulation profile and blood glucose level and the lipid profile. CTA and duplex scans for anatomical site of the lesion, occlusion or stenosis (single or multiple), proximal lesions to the affected segment like aortoiliac lesions, and runoff status distal to the affected segment were considered.

Technique of superficial femoral artery angioplasty and stenting

The policy of our institute is that all patients were admitted 1 day before or on the day of the procedure. A loading dose of clopidogrel 300 mg (Plavix 300 mg film-coated tablets; Sanofi, Reading, Berkshire, UK) and aspirin 150 mg (Aspirin 150 mg; Bayer AG 51368, Leverkusen, Germany) were given the night of the procedure. Both groins were prepared using an antiseptic solution; povidone–iodine (Betadine 10% antiseptic solution; El-Nile Company, EL Obour Industrial City, Egypt). The patient was in supine position and local anesthesia is infiltrated using xylocaine 2% (Xylocaine 2%; AstraZeneca, New Cairo city, Cairo, Egypt).

The ipsilateral antegrade access was the first choice and had been done in 26 cases. Contralateral approach was used in the case of a hostile ipsilateral groin, obesity, or high SFA origin and has been done in five cases. The retrograde transpopliteal or transpedal access in addition to antegrade access were used when antegrade crossing failed which had occurred in two cases. Anatomic and fluoroscopic localization of the common femoral artery was done for all patients. Intra-arterial injection of 5000 IU of heparin (Cal-Heparin 5000 IU; Amoun, EL Obour Industrial City, Egypt) was carried out immediately after insertion of the sheat. On table preintervention angiogram, lesion anatomy can be assessed using digital subtraction angiography. The TASC lesion classification for femoro-popliteal disease is as follows: crossing the lesion; lesions were crossed in an intraluminal manner (in 29 cases) where possible for stenotic lesions and short occlusions. Subintimal passage (in four cases) was used for longer occlusions or where intraluminal passage had failed. Balloon angioplasty and stenting (Balloon-Expandable Peripheral Stent System Ev3, Visi-pro 6 mm × 57 mm, Parkmore Business Park West, Ballybrit, Galway merit, Ireland); the indications were for SFA lesions with TASC II A, B, or C lesions and TASC II D lesions. Our indications for SFA stenting among SFA lesions were patients with residual stenosis covering more than 30% of the lumen after PTA, intimal flap, dissection, ulcerative plaque, and subintimal angioplasty. The majority of stents used in the SFA were self-expanding Nitinol devices; balloon-expandable stents were used rarely and only in heavily calcified bulky focal lesions.

Procedural features

Strict asepsis and sterile draping of both groins were mandatory. The choice between antegrade and contralateral retrograde access was dependent on a patient's body habitus and the presence of concomitant inflow iliac disease. The ipsilateral approach offered superior purchase, pushability, and trackability of devices for femoro-popliteal interventions. The ipsilateral retrograde transpopliteal access was used in case of a failed antegrade approach or a flush SFA occlusion. Combined antegrade and retrograde approaches were required for challenging long-segment femoro-popliteal occlusions or flush occlusions. Ideally, common femoral artery access is gained under ultrasound guidance to ensure fast and safe access with a single anterior wall puncture of a relatively disease-free vessel segment. Typically, a 5–6 Fr introducer sheath (the Prelude sheath introducer 6 F; Merit, Pittsburg city, USA) was placed. Long and/or curved up-and-over sheaths were used across the aortic bifurcation to allow for uncomplicated advancement of devices and regular angiographic control. A variety of standard or hydrophilic guidewires (AqWire; Hydrophilic Guidewire, Marlborough, Massachusetts, United States) were used for lesion crossing, used with variable diameters (0.014–0.035 inch) and lengths (180–300 cm) depending on the point of access, 0.035-inch compatible sufficed for most of the procedures. Stiff straight or angled hydrophilic guidewires were generally reserved for chronic total occlusion (CTO). Soft or stiff (half-stiff version) angled guidewires were recommended for subintimal recanalization. Over-the-wire and RX balloon catheter (ADMIRAL xtreme PTA Balloon Catheter, Calle Varsovia 36, Ciudad de México, Mexico) were recommended for balloon angioplasty of the femoro-popliteal artery. The size and length of the balloon were chosen on the basis of quantitative vessel analysis or usually by visual estimate in relation to a radiopaque ruler aligned in parallel with the target limb. The use of an inflation device was recommended for correct inflation to the nominal balloon pressure. Inflation times were highly variable and were up to 1 min moderate vessel wall calcifications and TASC D lesions have been found to be positive predictors for increased need of provisional femoro-popliteal stenting; overlap of nitinol stents must be minimized, because it relates to the increased risk of fracture and site-specific restenosis. Nitinol stent expansion may be suboptimal in case of heavily calcified eccentric or ring-like concentric plaques. Adequate predilation or even postdilation with a high pressure balloon is advisable to improve acute angiographic outcomes.

Distal runoff management

After procedure completion, angiography was performed for assessment of distal runoff. Simultaneous patellar tendon advancement (PTA) was performed below the knee. A 0.014- or 0.018-inch steerable guidewire was used as if in the coronary system. The guidewire was steered to and beyond the stenosis or through the occlusion; contrast injection from either the sheath/dilatation catheter helped localize anatomy. The dilatation catheter was positioned across the lesion. A balloon of 2.5 mm or 3.0 mm in size was inflated until loss of balloon wasting occurred and full inflation was achieved. The dilatation catheter remained inflated for 60 s, was deflated, and withdrawn, leaving the guidewire across the lesion. Contrast injection through the sheath allowed excellent visualization and assessment of the dilated area. In case of stent thrombosis, reintervention occurred to keep stent patency. So, secondary patency is defined as the durability after the successful second intervention occurs. In our study, secondary intervention was made by catheter-directed thrombolysis using Alteplase (Actilyse 50 mg; Boehringer Ingelheim, Ingelheim am Rhein city, Germany).

Statistical analysis

Data analysis was performed using the statistical software program (SPSS for Windows, version 21; SPSS Inc., Chicago, Illinois, USA). Normal distribution of variables was tested with the Shapiro–Wilk test. The results were expressed as number (percentages) for categorical variables and mean ± SD for numerical variables. Meanwhile, c2 test was done to assess the relationship between different categorical variables. The descriptive data for characteristics of lesion were expressed as mean ± SD, median (range), and confidence interval 95%. To assess the effect of smoking and diabetes mellitus on primary and secondary patency, independent sample t test was performed. For all statistical examinations, the results were considered significant at a P value less than or equal to 0.05.


  Results Top


This study was conducted on 30 patients with 33 critical lower limb ischemia (as three patients have bilateral affection). Males was 70% with mean ± SD age of 60.29 ± 9.49. Female was 30% with a mean ± SD age of 63.56 ± 9.34. There was a significant (P < 0.05) correlation between sex and lower limb ischemia.

CLI was recorded in 22 right lower limbs and in 11 left lower limbs. A total of 33 limbs underwent SFA stent insertion. There was a significant correlation between the occurrence of CLI and diabetes mellitus (P = 0.001), hypertension (P = 0.011), ischemic heart disease (P = 0.028), chronic renal failure (P = 0.001), and cerebrovascular disease (P = 0.001) [Table 1].
Table 1: Risk factors of peripheral arterial disease

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In all, 59% of lesions treated were chronic total occlusions and the remaining 41% were for stenotic lesions. The TASC II A group lesions were found in 11 (33.3%) limbs; TASC II B group lesions were found in 13 (39.4%) limbs; TASC II C group lesions were found in five (15.2%) limbs; and the TASC II C or D group lesions were found in four (12.1%) limbs. The mean lesion length was 6.79 ± 2.63 cm (range, 2–11 cm). The mean number of tibial arteries per patient was as follows: one vessel in 15 (45.5%) patients, two vessels in 11 (33.3%) patients, and three vessels in seven (21.2%) patients. The mean number of stents used was as follows: one stent in eight (24.2%) patients, two stents in 11 (33.3%) patients, and three stents in 14 (42.4%) patients. Self-expanding stents (90%) were more commonly deployed than balloon-expanding stents (10%). In all, 29 (87.9%) stents were deployed in an intraluminal manner compared with four (12.1%) via a subintimal route [Table 2].
Table 2: Characteristics of lesion and procedure in patients with peripheral arterial disease

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Stent surveillance was evaluated post-intervention and then at 6-month intervals by clinical examination (distal pulses and existence or absence of claudication or rest pain) and by vascular laboratory tools (ABI and arterial duplex ultrasound). Loss of patency by duplex is determined as the existence of an occlusion or a restenosis accompanied with a velocity ratio of greater than 4: 1 (relative to the segment proximal to the treated lesion), while PTA failure was defined as absence of patency by anatomic or hemodynamic measures with no efficient revascularization. Patency of arteries is believed to be lost once occlusion or restenosis was detected in any of managed lesions. The primary patency (%) rates at 12 months were 80.42 ± 5.17 for lesion length less than 5 cm, 78.38 ± 4.58 for lesion length = 5–10 cm, and 74.40 ± 11.22 for lesion length more than 10 cm. The primary patency (%) rates at 24 months were 68.47 ± 3.75 for lesion length less than 5 cm, 62.44 ± 6.39 for lesion length = 5–10 cm, and 0.00 ± 0.00 for lesion length more than 10 cm. The secondary patency (%) rates at 12 months were 83.79 ± 7.35 for lesion length less than 5 cm, 81.22 ± 3.07 for lesion length = 5–10 cm, and 75.60 ± 5.59 for lesion length more than 10 cm. The secondary patency (%) rates at 24 months were 78.58 ± 6.41 for lesion length less than 5 cm, 73.56 ± 1.67 for lesion length = 5–10 cm, and 32 ± 0.71 for lesion length more than 10 cm. Overall, the primary patency (%) rates at 12 months were 79.61 ± 6.53, and at 24 months were 56.45 ± 24.74. Meanwhile, the secondary patency (%) rates at 12 months were 81.85 ± 6.72, and at 24 months were 70.15 ± 17.23 [Table 3].
Table 3: Primary and secondary patency in patients with peripheral arterial disease

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Regarding the effect of smoke [Table 4] and diabetes [Table 5] on primary and secondary patency, there was a significant (P = 0.001) decrease of primary and secondary patency in smokers and in diabetic patients. The recorded complications were 11 (33.3%) patients occluded their stents during the study period. Of these patients, two (18.2%) underwent major amputation of which one patient had a bypass procedure that subsequently failed; three (27.2%) patients suffered from arterial access complications; one (9%) patient suffered from groin hematoma; one (9%) patient suffered from groin infection; two (18.2%) patients suffered from pseudoaneurysm, and two (18.2%) patients suffered from acute thrombosis/dissection.
Table 4: Effect of smoking on primary and secondary patency after 12 months in patients with peripheral arterial disease

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Table 5: Effect of diabetes mellitus on primary and secondary patency after 12 months in patients with peripheral arterial disease

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Concerning the status of distal runoff, the mean number of tibial arteries per patient was as follows: one vessel in 15 (45.5%) patients with 53% patency, two vessels in 11 (33.3%) patients with 66% patency, and three vessels in seven (21.2%) patients with 84% patency [Table 6].
Table 6: Status of distal runoff in patients with peripheral arterial disease

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  Discussion Top


The femoro-popliteal arteries are very common sites of involvement in patients with atherosclerotic PAD. A minority of those will require treatment for IC or CLI. PAD often is multilevel, and femoro-popliteal lesions may be combined either with more proximal aortoiliac disease or with distal infra-popliteal lesions, particularly in patients presenting with limb-threatening CLI. The effectiveness of peripheral bypass grafts and percutaneous transluminal angioplasty in accomplishing limb salvage has been known[7].

The recent technological advances in endovascular therapy have extended the applicability of minimally invasive treatment for challenging SFA lesions that were previously deemed inappropriate for endovascular therapy. Current infrainguinal endovascular options include balloon angioplasty, subintimal angioplasty, angioplasty with selective stenting, and primary stenting. Several trials have been published; however, the debate continues about which endovascular treatment is preferable[8],[9].

This study demonstrated that femoro-popliteal disease can be managed effectively with the use of a stent and can be used in higher-risk patient to forego the morbidity of a bypass procedure. Patency results may vary depending on lesion length, treatment of stenosis versus occlusions, baseline symptoms (IC versus CLI), number and status of runoff vessels, associated comorbidities (diabetes), and patient compliance to smoking cessation and antiplatelet therapy. Stent patency is significantly poorer in oral therapy-treated diabetic patients in comparison with those patients without diabetes[10]. Kay et al.[11] stated that patency affected badly with oral therapy than insulin therapy on diabetic patients, and there was no difference between nondiabetic and diabetic patients controlled with insulin therapy.

The nature of the lesion affects both the success rate and the long-term patency; more distal and longer lesions are more technically challenging and are less likely to stay open, and the presence of calcification is associated with a lower success rate; longer lesions need more than one stent. Increasing number of stents increases the rate of stent fracture and occlusion or stenosis. Kay et al.[11] reported a significant association between femoral artery patency and length of stented lesion. Schlager et al.[12] showed that intermediate-term in-stent restenosis remains a major problem even with current nitinol stent technology and complications increase proportional to stent numbers and lesion length.

Balloon-expandable metal stents are no longer used in the femoro-popliteal segment because of the risk of external compression and longitudinal axis deformation, but they are deployed predominately into heavily calcified lesions without significant effect on stent failure. Several recent randomized controlled trials of primary nitinol stent placement versus standard balloon angioplasty (absolute, fast, resilient, and astron trials) have shown significantly reduced risk of vessel restenosis at 12 months that was translated to numerically less events of repeat procedures (target lesion revascularization). However, this difference did not reach statistical significance, and therefore, primary nitinol stent placement in the femoro-popliteal arteries remains controversial[13],[14],[15].

Stent diameter is slightly oversized (maximum 1 mm) compared with reference vessel size, like that reported by Shammas[16]. The practice of spot stenting to deal with residual disease or dissections is proposed, whereas in case of primary stenting the stent length is chosen to achieve full lesion coverage of the baseline target vessel segment. Moderate vessel wall calcifications and TASC D lesions have been found to be positive predictors for increased need of provisional femoro-popliteal stenting. Many authors as Kay et al.[11], Watanabe et al.[17], and Lee and Katz[18] believed that the number of patent tibial arteries influence the patency of SFA and popliteal artery positively.

All patients in this study were on dual therapy of antiplatelet poststent deployment from the start. Svoboda et al.[19] stated that dual antiplatelet therapy with aspirin and clopidogrel shows no benefit in terms of increased 1-year patency rates after SFA stenting. Randomized trials are needed to better understand the absolute benefits and risks of dual antiplatelet therapy compared with aspirin alone for patients undergoing SFA stenting.

Kay et al.[11] believed that the number of patent tibial arteries influenced the patency of SFA and popliteal artery positively. In this study, the number of runoff vessels was also significantly different; the number of runoff vessels was lower in patients with CLI; and 1-year stent patency was reduced by almost half with one-vessel runoff compared with three-vessel runoff. Unlike other studies, Lee and Katz[18] reported that the number of patent tibial vessels did not influence the primary patency after nitinol stenting of the femoral and popliteal arteries.


  Conclusion Top


Diabetes mellitus, hypertension, ischemic heart disease, chronic renal failure, and cerebrovascular diseases are risk factors for the occurrence of CLI.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
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    Tables

  [Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6]



 

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