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Table of Contents
REVIEW ARTICLE
Year : 2021  |  Volume : 4  |  Issue : 2  |  Page : 46-53

The current state of endovascular intervention for critical limb ischemia: A systematic review


Department of Vascular Surgery, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China

Date of Submission22-Feb-2021
Date of Decision05-Mar-2021
Date of Acceptance06-Mar-2021
Date of Web Publication04-May-2021

Correspondence Address:
Dr. Chuanqi Cai
Department of Vascular Surgery, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430022
China
Ping Lv
Department of Vascular Surgery, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan-430022
China
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/2589-9686.313805

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  Abstract 


The treatment of critical limb ischemia (CLI) has long been a “hot spot” in medical science. It is widely believed that revascularization is the cornerstone of CLI therapy. However, there is currently no consensus on the best revascularization approach. Traditional open surgery is traumatic and associated with many complications. In recent years, great progress has been witnessed in terms of endovascular technology, gradually replacing open surgery in the treatment of CLI. In this review, the role of endovascular therapies in clinical practice, including conventional percutaneous transluminal angioplasty, bare-metal stent, and innovated drug-coated balloon, drug-eluting stent, bioresorbable vascular scaffold, cutting balloon angioplasty, atherectomy, intravascular lithotripsy, cryoplasty, and percutaneous deep venous arterialization is discussed.

Keywords: Critical limb ischemia, endovascular therapy, review


How to cite this article:
Wu H, Ye P, Chen Y, Li Y, Cai C, Lv P. The current state of endovascular intervention for critical limb ischemia: A systematic review. Vasc Invest Ther 2021;4:46-53

How to cite this URL:
Wu H, Ye P, Chen Y, Li Y, Cai C, Lv P. The current state of endovascular intervention for critical limb ischemia: A systematic review. Vasc Invest Ther [serial online] 2021 [cited 2021 Jul 27];4:46-53. Available from: https://www.vitonline.org/text.asp?2021/4/2/46/313805




  Introduction Top


Critical limb ischemia (CLI) is the most severe form of peripheral arterial disease (PAD) and is often considered the end stage of PAD. Approximately 10% of PAD aggravates to CLI),[1] corresponding to 4–6 in the Rutherford Classification.[2],[3],[4],[5] CLI is characterized by ischemic rest pain and tissue loss of lower limbs, difficulty in walking, significant decline in quality of life, and high amputation and mortality rate, thus, causing a huge economic burden on the patients and society. In the United States, the prevalence of CLI is about 1.3%,[3],[6] and the number of CLI patients is between 2 million and 3.4 million. It is conservatively estimated that by 2030, this figure will increase to between 2.4 and 4.7 million. Because of the extensive damage and increasing morbidity associated with CLI, the treatment of CLI has become a hotspot in vascular surgery. PAD treatment includes conservative management and revascularization by open surgery or endovascular technique. The goal of treatment is to reduce pain, promote wound healing, reduce amputation rate, improve the quality of life, and reduce mortality. Conservative management for CLI treatment is considered to complement physical revascularization, to modify the risk factors of CLI,[7] including antiplatelet therapy, anticoagulant therapy, antihypertensive therapy, lipid-lowering therapy, glycemic control in diabetes, smoking cessation, and regular physical activity,[7],[8],[9] and conservative management including intermittent pneumatic compression is even the only choice for the patients who are not suitable for surgery.[10],[11],[12] Conservative management has a certain effect in delaying atherosclerosis and improving the symptoms, but its effect on the prognosis of CLI is limited. Revascularization remains the main treatment option to improve the perfusion of the affected limb and has also been regarded as the cornerstone of CLI therapy.[3],[6],[13] Previous studies indicate that, if revascularization is not performed in time, amputation occurs in up to 40% of CLI patients, and a high mortality rate of up to 20% after 1 year is reported.[14] Bypass surgery was first performed in 1950[15] and has for a long time been considered as a standard and primary treatment, however, its drawbacks limit its application, such as difficulty in obtaining the appropriate autograft, graft occlusion, and high perioperative risk due to underlying diseases.[5] It has become less popular in recent years due to the development of endovascular treatment.[16] Intravascular therapy offers more options in some patients who are not suitable for open surgery and offers several benefits to patients such as less invasive, faster recovery, reduced perioperative morbidity, and mortality.[1],[3],[6],[17] Over the past 20 years, endovascular therapy has been widely used in patients. There are various types of endovascular treatment, including percutaneous transluminal angioplasty (PTA), bare-metal stents (BMS), improved therapies based on PTA-BMS, such as drug-coated balloons (DCB), drug-eluting stents (DES), cutting balloon angioplasty (CBA); bioresorbable vascular stents (BVS), etc., Besides, there are several cutting-edge technologies such as percutaneous deep venous arterialization (PDVA), and adventitial drug delivery. [Figure 1].
Figure 1: Common therapies for critical limb ischemia

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  Conventional Therapies for Critical Limb Ischemia Top


PTA and BMS are the most widely applied endovascular techniques. PTA, also known as balloon angioplasty, was first applied in clinical practice in the United States in 1964 and has become the most classic endovascular treatment. The principle behind the technique is the expansion of the occlusion or stenosis of the artery using a dilatable balloon catheter, the plaque is compressed, and the lumen expands due to hyperextension to restore the blood flow. PTA treatment also has drawbacks, such as restenosis due to elastic retraction of the vessel, and ruptured plaques may occlude the distal artery blood flow. Besides, due to the passive stretching of the arterial wall, the vessel wall may be injured, and local dissection may occur.[18],[19] BMS attempts to overcome the majority of the shortcomings of PTA. In 1994, Cordis, an American company, for the first time introduced the metal stent applied to coronary arteries. Since then, BMS has been widely applied to visceral, peripheral, and coronary arteries.[20] The materials include tantalum, medical stainless steel, and Nitinol, and can be divided into balloon dilatation and self-expansion based on the expansion properties. Major limitation of bare stents is the increased risk of stent fracture due to the higher mobility of the knee joint; therefore, stent placement in this area should be performed with caution. For patients with occlusion of infrapopliteal artery, stent placement alone is very difficult due to the small size of the vascular lumen and extensive range of lesions. Besides, the low blood pressure, and blood flow in the distal arteries, is likely to form in-stent stenosis.[5]

For many years, the comparison between bypass surgery and PTA has remained controversial. Antoniou et al.[15] assessed the effect of bypass surgery in patients with CLI, and the results showed that, compared with PTA, bypass surgery has more complications and longer hospital stay. Koifman et al.[21] compared different treatment strategies including bypass surgery, PTA, BMS, DES, and DCB, and the results showed no significant difference between the strategies in terms of amputation or survival rates. However, the comparison between bypass and PTA-BMS remains controversial, as there are still many drawbacks associated with PTA-BMS, even though it has greatly promoted the development of intravascular technology, and improved the treatment of peripheral artery disease.


  Improved and Innovate Endovascular Therapies Top


In recent years, based on PTA and BMS, continuous improvement and upgrading of the endovascular technique have revolutionized PAD treatment.[19] Nowadays, there are several endovascular techniques, and each has its advantages. These techniques can either be applied alone and sometimes in combination, to deal with severe cases, thus greatly benefiting more patients.

Drug elution therapy

Drug-coated balloons

DCB were developed to solve the problem of restenosis after PTA and stent implantation. The surface of this special balloon is coated with drugs such as paclitaxel and rapamycin. While dilating the site of stenosis, the drugs continue to act on the intima of the vessel (Animal experiments have shown that paclitaxel activity can last up to 180 days)[22] to inhibit intima proliferation, and improve the vascular patency rate and reduce the incidence of restenosis.[23],[24] This technique is not only used in coronary arteries but also widely used in peripheral artery stenosis, and most recently in femoral and popliteal arteries. Currently, there are only three DCB available in the USA, including IN.PACT, Lutonix, and Stellarex, The main difference among the three is the nature of the coating, drug, and excipient molecules concentration.[23] Early clinical trials, such as THUNDER showed that the use of paclitaxel-coated balloons significantly reduced late arterial lumen loss and target-lesion revascularization (TLR).[25] In the IN. PACT SFA trial in 2015, 331 patients with superficial femoral and popliteal artery ischemia was divided into DCB group and PTA group. After 12 months of follow-up, the primary patency rate of the patients in the DCB group was higher (82.2% vs. 52.4%), while the incidence of TLR was lower (2.4% vs. 20.6%).[26] Similarly, the DCB provides an option for stenosis or occlusion of the below-the-knee (BTK) artery. Clinical data from a previous study showed that out of the 248 patients with infrapopliteal artery disease treated with Lutonix DCB, improvement of at least 1 Rutherford category was seen in 130 (59.1%) limbs after 1 year or at the last follow-up, while 104 (80.0%) of those limbs showed an improvement of ≥2 categories.[27] However, the study by Ipema et al.[28] showed that, for patients with BTK artery disease, no significant difference was found between PTA and DCB in limb salvage, survival, restenosis, and TLR. In addition, the use of DCB seems to increase the risk of embolic events, which may be related to increased paclitaxel dosage, or inconsistencies in the indications for amputation.[23],[29] Therefore, high-level clinical evidence is needed before DCB can be used as a routine treatment for BTK artery disease. Besides, for long-segment lesions, multiple stents are often required, DCB may be advantageous.[24]

Drug-eluting stents

Similar to DCB, DES are designed to reduce restenosis. Drugs such as paclitaxel, sirolimus, and everolimus are released at different rates to inhibit inflammation and intimal hyperplasia. ACHILLES trial randomly divided 200 patients with BTK artery disease into two groups. After 1-year of follow-up, patients with DESs were found to have a higher vascular patency rate (75% vs. 57%) and a lower vascular restenosis rate (22% vs. 42%) compared with PTA patients.[30] A multi-centered randomized trial conducted by Bausback et al.[31] showed that DES and DCB had similar effects in patients with femoral-popliteal artery lesions during 1 year follow-up, while follow up 3years, the advantages of DES showed. Another study of 8602 patients showed that the patency rate of DES was better compared with BMS in infrapopliteal arteries (primary patency: 73% vs. 50% at 1 year).[32]

Bioresorbable vascular scaffolds

Permanent metal stents may prevent vasomotion, affect the late lumen enlargement, impair automatic regulation and adaptive remodeling of vessels, and have a persistent vascular inflammatory response. Besides, metallic stents complicate future endovascular interventions and significantly limit peripheral imaging on computed tomography, and even cause stent fracture or in-stent restenosis.[33],[34],[35] BVS may overcome all the above-mentioned drawbacks. This type of stent not only provides mechanical support against recoil and drug delivery to vessels as a DES but can also be completely resorbed by the body through the inert process of hydrolysis as the blood vessel wall is reshaped [Figure 2]. There are several types of bioabsorbable stents, such as Absorb BVS (Abbott Vascular, California, USA), and DESolve (Elixir Medical, Sunnyvale, CA), which have a PLLA backbone, and Magmaris (BIOTRONIK AG, Buelach, Switzerland) which is made of a refined slower-degradable magnesium alloy.[35],[36] Absorb BVS is one of the most frequently used BVS and uses PLLA as the stent matrix material, amorphous poly-D, L-lactide, (PDLLA) as the coating, and everolimus as the drug coating. PLLA and PDLLA can be degraded into lactic acid, and finally into carbon dioxide and water, while everolimus can effectively inhibit intimal hyperplasia.[33],[35] Varcoe et al.[33] analyzed the clinical data of 33 patients with BTK ischemia in 38 limbs. Clinical improvement was observed in 30 (79%) patients after 12 ± 3.9 months of follow-up, restenosis was found in only 3 stents (6%), the primary patency rates at 12 and 24 months follow-up were 96% and 84.6%, respectively, complete wound healing was reported in 64% of patients with ulcers and the limb-salvage rate was 100%. A study by Dia et al.[34] showed that 49 absorbable stents were implanted in 31 patients with BTK artery disease, primary patency rate was 96.7% at 12 months and 87.1% at 24 months follow-up. These findings indicate the feasibility of BVS, however, there are several challenges associated with BVS development, for example, providing sufficient vessel support against recoil while minimizing the time required for absorption, reducing the storage cost, and formulating the best plan of dual antiplatelet therapy, etc.[36]
Figure 2: Comparison of bioresorbable vascular scaffolds and other types of vascular stents

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Cutting balloon angioplasty

CBA is also improved based on common balloon angioplasty. There are 3–4 sharp microtomes fixed longitudinally on the surface of the balloon. During the expansion process, it produces a longitudinal linear incision to the vessel wall and plaque, reduces circumferential stress, achieves the “pre-cut” effect, reduces the pressure required during balloon expansion, has less vessel wall damage and irritation, and correspondingly reduces the intimal hyperplasia.[37],[38] Therefore, the cutting balloon has a controllable and predictable effect in terms of expansion. This method has unique advantages over conventional balloon angioplasty for highly diseased and heavily calcified vessels. Cotroneo et al.[39] collected clinical data on 84 patients with femoropopliteal occlusions; 40 patients (67 lesions) were treated with conventional PTA and 44 patients (75 lesions) with CBA. Four dissections occurred in 67 lesions in the PTA group and self-expanding stents were subsequently implanted, but not in the CBA group. After 6-, 12-, and 24-month follow-up, the primary and secondary patency rates were found to be higher in the CBA group than in the PTA group. However, there are no other clinical studies on CBA treatment, and the available evidence is not sufficient.

Atherectomy

Unlike endarterectomy under open surgery, atherectomy is a new treatment modality, including directional atherectomy (DA), rotational atherectomy (RA), orbital atherectomy (OA), and laser atherectomy (LA).[40] They are all based on interventional techniques that maximize restoration of blood flow by removing plaque that occludes blood flow, thereby eliminating stenosis in diseased vessels. At present, there are several plaque resection systems in the market, and the principle to arterial plaque elimination of the 4 core devices are not the same. The Food and Drug Administration-approved directional plaque excision system includes SilverHawk, TurboHawk, HawkOne, etc., SilverHawk is one of the most widely used devices. As the device is advanced through the lesion, the plaque is collected and stored in a conical container at the distal end of the catheter, it is easier to remove eccentric lesions with directional control, and can also be used with PTA.[41],[42],[43] However, an embolic protection device is recommended due to the possibility of distal embolism, especially in heavily calcified vessels.[42] The Rotablator system was first used in 1988, with the main part being an elliptical brass burr which is coated with thousands of microscopic diamond crystals [Figure 3], and the hard plaque is removed by the rotating burr, while the normal, soft tissue is protected from being cut and damaged.[42] With decades of development, common RA systems include Phoenix (Philips), Jetstream, RotaLink and Rotarex, Jetstream and Rotarex combine the functions of atherectomy and aspiration to reduce the occurrence of distal embolic events. Janas et al.[41] compared the outcomes of DA with RA, by dividing the patients into the DA (85 patients) and RA (97 patients) groups and the mean follow-up for AD and AR was 282.6 ± 147.4 and 255.7 ± 186.1 days. They found that there was no significant difference in the mortality, amputation, or bailout stenting between the two groups, but the incidence of TLR in the DA group was higher than that in the RA group (29% vs. 15.9%, P = 0.03). OA system includes Diamondback 360°, Predator 360°, Stealth 360°, etc.[44] OA is used for calcified lesions, while LA, to be described later, is used for soft or mixed plaques.[45],[46] Samuel et al.[45] evaluated the safety and effectiveness of infrainguinal artery revascularization between OA with LA, and the results showed that the risk of occlusion was lower in OA. LA ablates the arterial plaque in direct contact with the catheter with controllable high-energy UV light. Due to the short wavelength (300 nm) and shallow absorption depth (0.05 mm), the damage caused to the deep-lying tissue is also small.[47] Besides, LA can be combined with PTA, which is more effective than PTA alone, while combining with DCB may improve the therapeutic effect by increasing drug absorption.[48] Alexandros et al.[47] collected the clinical data from 300 CLI patients, with a total of 461 lesions in 343 limbs. All patients were treated with LA combined with PTA, 33% were implanted with stents. 156 patients (45%) became asymptomatic or achieved significant clinical improvement at a mean follow-up of 28 months; 60 (17%) remained with CLI, 18 (5%) had minor amputations, and 30 (9%) underwent major amputations. The EXCITE ISR trial showed that LA combined with PTA was associated with 52% reduction in TLR compared with PTA alone.[49]
Figure 3: Rotational atherectomy burr

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However, Damianos et al.[50] showed no significant difference in TLR and amputation rates between the two strategies after 1- or 2-year follow-up, however, the data quality in this study was limited. Currently, clinical evidence on LA treatment is not sufficient; however, it provides CLI patients who cannot undergo surgery with an additional treatment opportunity.

Intravascular lithotripsy

For patients with high calcification of the vascular wall, the effect of general vascular interventional therapy is poor, and such patients urgently need to improve blood supply to the lower limbs. Intravascular lithotripsy (IVL) is a technology based on lithotripsy and provides an option for such patients. The principle behind lithotripsy is similar to that of extracorporeal shock wave lithotripsy. It utilizes the mechanical energy generated by sonic pressure waves to selectively fracture the high-density calcifications, improve vascular compliance, increase blood supply, and reduce vascular injury. Besides, it can also provide better conditions for balloon angioplasty. Brodmann et al.[51],[52] recruited 35 patients and 60 patients, respectively, in the DISRUPT PAD I, and DISRUPT PAD II clinical studies. The 35 patients in DISRUPT PADI successfully received IVL, the stenosis decreased from 76.3% to 23.4%, with an acute gain of 2.9 mm, and no major adverse events were reported after 6 months follow-up. Patients in DISRUPT PADII study also showed similar results, with a final 24.2% residual stenosis and an average acute gain of 3.0 mm. After 12 months of follow-up, primary patency was 54.5%, and clinically driven TLR was 20.7%. The Disrupt PAD III study included 118 patients treated with IVL, suggesting that IVL was a safe and effective method for calcified, stenotic iliac disease. A total of 101 patients were treated primarily for claudication or CLI, while 17 patients were treated to optimize the iliac vasculature for large-bore access. The results showed that there was no significant difference in the final mean residual stenosis between the groups.[53] These clinical studies demonstrate the safety and efficacy of IVL to some extent. IVL is also safe and feasible in patients with BTK artery disease. The Disrupt BTK trial which included 20 patients with calcified infrapopliteal stenosis, revealed that IVL was successful in 19 patients, no major adverse events occurred, the diameter stenosis rate was reduced by 46.5%, and all patients achieved residual diameter stenosis ≤50% after 30-day follow-up.[54] It is important to note that, due to the small sample size and short follow-up period, the four clinical studies only confirmed the short-term postoperative effect of IVL. There are no reported clinical studies with large patient samples and long follow-up periods and should be considered in future studies.

Cryoplasty

Cryoplasty therapy is a new technique that combines traditional PTA with local cryotherapy and can supplement CLI treatment. The mechanism is that N2O, as an expansion medium, absorbs heat, changes from the liquid phase to the gas phase, and cools the surface temperature of the balloon to −10°C. The apoptosis of proliferative cells, especially smooth muscle cells is induced by hypothermia. At the same time, the inflated balloon dilates the artery stenosis at a nominal pressure of 8 atm.[55] Therefore, this method is mainly applied to the site of restenosis lesions. The PolarCath™ Peripheral Dilatation System (Boston Scientific, Natick, MA, USA) is commonly used in clinical practice and characterized by a dual balloon. Samson et al.[56] analyzed clinical data of 32 patients who underwent cryoplasty. After 12 months of follow-up, freedom from restenosis for lesions and limbs treated was 82.2% and 84.4%, respectively, which to some extent confirms the feasibility of cryoplasty. However, there were some limitations in this study, such as the small sample size, lack of control, and the short follow-up period. Another study compared the effects of CBA and cryoplasty, and showed that stenosis-free survival was significantly lower in the cyroplasty cohort after 3- or 6-month follow-up.[55] Although cryoplasty remains highly contentious, there is a need for further research in the future. However, cryoplasty provides a new idea for endovascular treatment.


  The Most Up-to-date Technology Top


Percutaneous deep venous arterialization

Various endovascular techniques have led to an increase in the number of patients benefiting from successful revascularization. However, 14%–20% of patients are reported not to be suitable for the approaches mentioned above due to extensive occlusion in BTK arteries.[57] These patients are clinically referred to as “no-option” CLI patients, and they tend to have complications such as diabetes, end-stage kidney disease and thromboangiitis obliterans.[58] PDVA is one of the recent treatments for CLI and provides patients with a treatment option. It creates arteriovenous fistula (AVF) between the artery and the deep vein using interventional techniques, and realizes arterialization of the target vein, thus increasing blood supply at the site of ischemia [Figure 4]. Therefore, the implementation of PDVA requires at least one infrapopliteal artery and one deep vein to remain unobstructed. Limflow is the special device used in PDVA, and consists of an arterial and venous catheter set, a forward-cutting 4F valvulotome with hooks, a polytetrafluoroethylene (PTFE) covered stent and an ultrasound console for localization.[57],[59] The medical procedure is performed as follows: (1) identify the best crossing point where the AVF needs to be created with the help of medical imaging; (2) obtain femoral artery access and tibial vein access, respectively, using the Seldinger technique; (3) position the arterial and venous catheter to the best crossing point, respectively, advance the crossing needle from artery to vein, advance a 0.014-inch guidewire into the vein from the puncture site through the arterial catheter crossing needle; (4) make the valves distal to the crossing point incompetent using valvulotome; (5) implant a covered stent (sometimes multiple stents may be required) through the crossing point, the AVF is created.[57],[59],]60],[61] The study conducted by Schmidt et al.[60] evaluated the midterm results of patients suffering from no-option chronic limb-threatening ischemia. They analyzed the clinical data of 32 patients treated using the Limflow device. Among them, 31 patients (96.9%) successfully underwent PDVA. After 6, 12, and 24 months of follow-up, amputation-free survival was 83.9%, 71.0%, and 67.2%, limb salvage was 86.8%, 79.8%, and 79.8%, complete wound healing was 36.6%, 68.2%, and 72.7%, respectively. Therefore, PDVA may be recommended in the treatment of no-option patients to prevent amputation and promote ulcer healing. Despite the limited sample size, these results are encouraging, and there is enough evidence to believe that PDVA may be an option for CLI treatment in future.
Figure 4: Depiction of percutaneous deep venous arterialization procedure

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Others

In recent years, Micro Medical Solution, an American company, has designed a braided nickel-titanium alloy self-expanding metal stent for the infrapopliteal artery, which can be deployed through anterograde or retrograde approaches. Adventitial drug delivery is a novel approach that minimizes the restenosis by delivering the antiproliferative agents directly to the adventitia to inhibit the migration of fibroblasts from the adventitia toward the intima which is recently well evaluated in basic research and translational research,[62],[63],[64],[65],[66] it may reduce the resistance of atherosclerotic plaque on drug absorption.[67],[68],[69] Percutaneous bypass is a cutting-edge technology for femoral-popliteal bypass via the percutaneous route.[68] In 2020, Zhang Yuguang's team from the Ninth People's Hospital affiliated with Shanghai Jiao Tong University developed a brand-new manufacturing method of the microvascular stent by using the bionic 3D self-shaping method, which has a good prospect of clinical transformation.[70]


  Conclusion Top


There are several endovascular treatments for CLI, most of which are developed from PTA and BMS, and their efficacy is widely accepted. The goal of treatment is to revascularize and improve blood supply. However, the prognosis of CLI remains unsatisfactory, and a large number of patients lack the opportunity of surgery, face amputation, or even die. In future, breakthroughs in endovascular treatment will provide more reliable evidence-based medical data to guide clinical practice, and reach a consensus on the treatment of CLI to benefit more patients.

Financial support and sponsorship

This research was supported by the National Natural Science Foundation of China (NO. 82000729) to C.C.

Conflicts of interest

There are no conflicts of interest.



 
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