|Year : 2021 | Volume
| Issue : 2 | Page : 46-53
The current state of endovascular intervention for critical limb ischemia: A systematic review
Hongxiao Wu, Pin Ye, Yunfei Chen, Yiqing Li, Chuanqi Cai, Ping Lv
Department of Vascular Surgery, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
|Date of Submission||22-Feb-2021|
|Date of Decision||05-Mar-2021|
|Date of Acceptance||06-Mar-2021|
|Date of Web Publication||04-May-2021|
Dr. Chuanqi Cai
Department of Vascular Surgery, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430022
Department of Vascular Surgery, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan-430022
Source of Support: None, Conflict of Interest: None
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|| |
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), corresponding to 4–6 in the Rutherford Classification.,,, 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%,, 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, including antiplatelet therapy, anticoagulant therapy, antihypertensive therapy, lipid-lowering therapy, glycemic control in diabetes, smoking cessation, and regular physical activity,,, and conservative management including intermittent pneumatic compression is even the only choice for the patients who are not suitable for surgery.,, 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.,, 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. Bypass surgery was first performed in 1950 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. It has become less popular in recent years due to the development of endovascular treatment. 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.,,, 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].
| Conventional Therapies for Critical Limb Ischemia|| |
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., 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. 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.
For many years, the comparison between bypass surgery and PTA has remained controversial. Antoniou et al. 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. 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|| |
In recent years, based on PTA and BMS, continuous improvement and upgrading of the endovascular technique have revolutionized PAD treatment. 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
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) to inhibit intima proliferation, and improve the vascular patency rate and reduce the incidence of restenosis., 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. 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). 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%). 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. However, the study by Ipema et al. 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., 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.
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. A multi-centered randomized trial conducted by Bausback et al. 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).
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.,, 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., 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., Varcoe et al. 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. 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.
|Figure 2: Comparison of bioresorbable vascular scaffolds and other types of vascular stents|
Click here to view
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., 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. 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.
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). 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.,, However, an embolic protection device is recommended due to the possibility of distal embolism, especially in heavily calcified vessels. 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. 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. 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. OA is used for calcified lesions, while LA, to be described later, is used for soft or mixed plaques., Samuel et al. 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. 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. Alexandros et al. 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.
However, Damianos et al. 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.
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., 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. 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. 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 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. 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. 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. 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|| |
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. 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. 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., 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.,,]60], The study conducted by Schmidt et al. 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|
Click here to view
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,,,,, it may reduce the resistance of atherosclerotic plaque on drug absorption.,, Percutaneous bypass is a cutting-edge technology for femoral-popliteal bypass via the percutaneous route. 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.
| Conclusion|| |
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.
| References|| |
Farber A, Eberhardt RT. The current state of critical limb ischemia: A systematic review. JAMA Surg 2016;151:1070-7.
Mustapha JA, Diaz-Sandoval LJ, Saab F. Innovations in the endovascular management of critical limb ischemia: Retrograde tibiopedal access and advanced percutaneous techniques. Curr Cardiol Rep 2017;19:68.
Levin SR, Arinze N, Siracuse JJ. Lower extremity critical limb ischemia: A review of clinical features and management. Trends Cardiovasc Med 2020;30:125-30.
Spreen MI, Martens JM, Knippenberg B, van Dijk LC, de Vries JP, Vos JA, et al
. Long-term follow-up of the PADI trial: Percutaneous transluminal angioplasty versus drug-eluting stents for infrapopliteal lesions in critical limb ischemia. J Am Heart Assoc 2017;6:e004877.
Haghighat L, Altin SE, Attaran RR, Mena-Hurtado C, Regan CJ. Review of the latest percutaneous devices in critical limb ischemia. J Clin Med 2018;7:82.
Dua A, Lee CJ. Epidemiology of peripheral arterial disease and critical limb ischemia. Tech Vasc Interv Radiol 2016;19:91-5.
Conte MS, Bradbury AW, Kolh P, White JV, Dick F, Fitridge R, et al
. Global vascular guidelines on the management of chronic limb-threatening ischemia. J Vasc Surg 2019;69:3S-125.e40.
Parvar SL, Fitridge R, Dawson J, Nicholls SJ. Medical and lifestyle management of peripheral arterial disease. J Vasc Surg 2018;68:1595-606.
Gerhard-Herman MD, Gornik HL, Barrett C, Barshes NR, Corriere MA, Drachman DE, et al
. 2016 AHA/ACC Guideline on the Management of Patients with Lower Extremity Peripheral Artery Disease: Executive summary: A report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation 2017;135:e686-725.
Hassanshahi M, Khabbazi S, Peymanfar Y, Hassanshahi A, Hosseini-Khah Z, Su YW, et al. Critical limb ischemia: Current and novel therapeutic strategies. J Cell Physiol 2019; 234: 14445-59.
Louridas G, Saadia R, Spelay J, Abdoh A, Weighell W, Arneja AS, et al
. The ArtAssist Device in chronic lower limb ischemia. A pilot study. Int Angiol 2002;21:28-35.
Sultan S, Hamada N, Soylu E, Fahy A, Hynes N, Tawfick W. Sequential compression biomechanical device in patients with critical limb ischemia and nonreconstructible peripheral vascular disease. J Vasc Surg 2011;54:440-6.
Di Primio M, Angelopoulos G, Lazareth I, Priollet P, Zins M, Emmerich J, et al
. Innovative endovascular approach for limb salvage in critical limb ischemia. J Med Vasc 2020;45:23-7.
Norgren L, Hiatt WR, Dormandy JA, Nehler MR, Harris KA, Fowkes FG, et al
. Inter-society consensus for the management of peripheral arterial disease (TASC II). J Vasc Surg 2007;45 Suppl S: S5-67.
Antoniou GA, Georgiadis GS, Antoniou SA, Makar RR, Smout JD, Torella F. Bypass surgery for chronic lower limb ischaemia. Cochrane Database Syst Rev 2017;4:CD002000.
Naghi J, Yalvac EA, Pourdjabbar A, Ang L, Bahadorani J, Reeves RR, et al
. New developments in the clinical use of drug-coated balloon catheters in peripheral arterial disease. Med Devices (Auckl) 2016;9:161-74.
Kinlay S. Management of critical limb ischemia. Circ Cardiovasc Interv 2016;9:e001946.
Kim TI, Schneider PA. New innovations and devices in the management of chronic limb-threatening ischemia. J Endovasc Ther 2020;27:524-39.
Schnorr B, Albrecht T. Drug-coated balloons and their place in treating peripheral arterial disease. Expert Rev Med Devices 2013;10:105-14.
Karnabatidis D, Katsanos K, Siablis D. Infrapopliteal stents: Overview and unresolved issues. J Endovasc Ther 2009;16 Suppl 1:I153-62.
Koifman E, Lipinski MJ, Buchanan K, Yu Kang W, Escarcega RO, Waksman R, et al
. Comparison of treatment strategies for femoro-popliteal disease: A network meta-analysis. Catheter Cardiovasc Interv 2018;91:1320-8.
Speck U, Cremers B, Kelsch B, Biedermann M, Clever YP, Schaffner S, et al
. Do pharmacokinetics explain persistent restenosis inhibition by a single dose of paclitaxel? Circ Cardiovasc Interv 2012;5:392-400.
Lindquist J, Schramm K. Drug-eluting balloons and drug-eluting stents in the treatment of peripheral vascular disease. Semin Intervent Radiol 2018;35:443-52.
Armstrong EJ, Bishu K, Waldo SW. Endovascular treatment of infrapopliteal peripheral artery disease. Curr Cardiol Rep 2016;18:34.
Tepe G, Zeller T, Albrecht T, Heller S, Schwarzwälder U, Beregi JP, et al
. Local delivery of paclitaxel to inhibit restenosis during angioplasty of the leg. N Engl J Med 2008;358:689-99.
Tepe G, Laird J, Schneider P, Brodmann M, Krishnan P, Micari A, et al
. Drug-coated balloon versus standard percutaneous transluminal angioplasty for the treatment of superficial femoral and popliteal peripheral artery disease: 12-month results from the IN.PACT SFA randomized trial. Circulation 2015;131:495-502.
Steiner S, Schmidt A, Bausback Y, Bräunlich S, Ulrich M, Banning-Eichenseer U, et al
. Single-center experience with lutonix drug-coated balloons in infrapopliteal arteries. J Endovasc Ther 2016;23:417-23.
Ipema J, Huizing E, Schreve MA, de Vries JP, Ünlü Ç. Editor's choice – Drug coated balloon angioplasty vs. standard percutaneous transluminal angioplasty in below the knee peripheral arterial disease: A systematic review and meta-analysis. Eur J Vasc Endovasc Surg 2020;59:265-75.
Zeller T, Baumgartner I, Scheinert D, Brodmann M, Bosiers M, Micari A, et al
. Drug-eluting balloon versus standard balloon angioplasty for infrapopliteal arterial revascularization in critical limb ischemia: 12-month results from the IN.PACT DEEP randomized trial. J Am Coll Cardiol 2014;64:1568-76.
Scheinert D, Katsanos K, Zeller T, Koppensteiner R, Commeau P, Bosiers M, et al
. A prospective randomized multicenter comparison of balloon angioplasty and infrapopliteal stenting with the sirolimus-eluting stent in patients with ischemic peripheral arterial disease: 1-year results from the ACHILLES trial. J Am Coll Cardiol 2012;60:2290-5.
Bausback Y, Wittig T, Schmidt A, Zeller T, Bosiers M, Peeters P, et al
. Drug-eluting stent versus drug-coated balloon revascularization in patients with femoropopliteal arterial disease. J Am Coll Cardiol 2019;73:667-79.
Almasri J, Adusumalli J, Asi N, Lakis S, Alsawas M, Prokop LJ, et al
. A systematic review and meta-analysis of revascularization outcomes of infrainguinal chronic limb-threatening ischemia. J Vasc Surg 2018;68:624-33.
Varcoe RL, Schouten O, Thomas SD, Lennox AF. Experience with the absorb everolimus-eluting bioresorbable vascular scaffold in arteries below the knee: 12-month clinical and imaging outcomes. JACC Cardiovasc Interv 2016;9:1721-8.
Dia A, Venturini JM, Kalathiya RJ, Besser S, Estrada JR, Friant J, et al. Two-year follow-up of bioresorbable vascular scaffolds in severe infra-popliteal arterial disease. Vascular 2020; Sep 14;1708538120954947.
Sotomi Y, Onuma Y, Collet C, Tenekecioglu E, Virmani R, Kleiman NS, et al
. Bioresorbable scaffold: The emerging reality and future directions. Circ Res 2017;120:1341-52.
Regazzoli D, Leone PP, Colombo A, Latib A. New generation bioresorbable scaffold technologies: An update on novel devices and clinical results. J Thorac Dis 2017;9:S979-85.
Davies MG, Anaya-Ayala JE. Endovascular techniques in limb salvage: Cutting, cryo, brachy, and drug-eluting balloons. Methodist Debakey Cardiovasc J 2013;9:69-72.
Cejna M. Cutting balloon: Review on principles and background of use in peripheral arteries. Cardiovasc Intervent Radiol 2005;28:400-8.
Cotroneo AR, Pascali D, Iezzi R. Cutting balloon versus conventional balloon angioplasty in short femoropopliteal arterial stenoses. J Endovasc Ther 2008;15:283-91.
Franzone A, Ferrone M, Carotenuto G, Carbone A, Scudiero L, Serino F, et al
. The role of atherectomy in the treatment of lower extremity peripheral artery disease. BMC Surg 2012;12 Suppl 1:S13.
Janas A, Milewski K, Buszman P, Kolarczyk-Haczyk A, Trendel W, Pruski M, et al
. Comparison of long-term outcomes after directional versus rotational atherectomy in peripheral artery disease. Postepy Kardiol Interwencyjnej 2020;16:76-81.
Akkus NI, Abdulbaki A, Jimenez E, Tandon N. Atherectomy devices: Technology update. Med Devices (Auckl) 2015;8:1-0.
Garcia LA, Lyden SP. Atherectomy for infrainguinal peripheral artery disease. J Endovasc Ther 2009;16 2 Suppl 2:Ii105-15.
Lee MS, Mustapha J, Beasley R, Chopra P, Das T, Adams GL. Impact of lesion location on procedural and acute angiographic outcomes in patients with critical limb ischemia treated for peripheral artery disease with orbital atherectomy: A CONFIRM registries subanalysis. Catheter Cardiovasc Interv 2016;87:440-5.
Lai SH, Roush BB, Fenlon J, Munn J, Rummel M, Johnston D, et al
. Outcomes of atherectomy for lower extremity ischemia in an office endovascular center. J Vasc Surg 2020;71:1276-85.
Shlofmitz E, Shlofmitz R, Lee MS. Orbital atherectomy: A comprehensive review. Interv Cardiol Clin 2019;8:161-71.
Mallios A, Blebea J, Buster B, Messiner R, Taubman K, Ma H. Laser atherectomy for the treatment of peripheral arterial disease. Ann Vasc Surg 2017;44:269-76.
Kokkinidis DG, Behan S, Jawaid O, Hossain P, Giannopoulos S, Singh GD, et al
. Laser atherectomy and drug-coated balloons for the treatment of femoropopliteal in-stent restenosis: 2-Year outcomes. Catheter Cardiovasc Interv 2020;95:439-46.
Dippel EJ, Makam P, Kovach R, George JC, Patlola R, Metzger DC, et al
. Randomized controlled study of excimer laser atherectomy for treatment of femoropopliteal in-stent restenosis: Initial results from the EXCITE ISR trial (EXCImer Laser Randomized Controlled Study for Treatment of FemoropopliTEal In-Stent Restenosis). JACC Cardiovasc Interv 2015;8:92-101.
Kokkinidis DG, Giannopoulos S, Jawaid O, Cantu D, Singh GD, Armstrong EJ. Laser atherectomy for infrapopliteal lesions in patients with critical limb ischemia. Cardiovasc Revasc Med 2021;23:79-83.
Brodmann M, Werner M, Holden A, Tepe G, Scheinert D, Schwindt A, et al
. Primary outcomes and mechanism of action of intravascular lithotripsy in calcified, femoropopliteal lesions: Results of Disrupt PAD II. Catheter Cardiovasc Interv 2019;93:335-42.
Brodmann M, Werner M, Brinton TJ, Illindala U, Lansky A, Jaff MR, et al
. Safety and performance of lithoplasty for treatment of calcified peripheral artery lesions. J Am Coll Cardiol 2017;70:908-10.
Armstrong EJ, Soukas PA, Shammas N, Chamberlain J, Pop A, Adams G, et al
. Intravascular lithotripsy for treatment of calcified, stenotic iliac arteries: A cohort analysis from the disrupt PAD III study. Cardiovasc Revasc Med 2020;21:1262-8.
Brodmann M, Holden A, Zeller T. Safety and feasibility of intravascular lithotripsy for treatment of below-the-knee arterial stenoses. J Endovasc Ther 2018;25:499-503.
Shin SH, Baril DT, Chaer RA, Makaroun MS, Marone LK. Cryoplasty offers no advantage over standard balloon angioplasty for the treatment of in-stent stenosis. Vascular 2013;21:349-54.
Samson RH, Showalter DP, Lepore MR Jr., Ames S. CryoPlasty therapy of the superficial femoral and popliteal arteries: A single center experience. Vasc Endovascular Surg 2006;40:446-50.
Del Giudice C, Van Den Heuvel D, Wille J, Mirault T, Messas E, Ferraresi R, et al
. Percutaneous deep venous arterialization for severe critical limb ischemia in patients with no option of revascularization: Early experience from two European centers. Cardiovasc Intervent Radiol 2018;41:1474-80.
Ho VT, Gologorsky R, Kibrik P, Chandra V, Prent A, Lee J, et al
. Open, percutaneous, and hybrid deep venous arterialization technique for no-option foot salvage. J Vasc Surg 2020;71:2152-60.
Schreve MA, Lichtenberg M, Ünlü Ç, Branzan D, Schmidt A, van den Heuvel DA, et al
. PROMISE international; a clinical post marketing trial investigating the percutaneous deep vein arterialization (LimFlow) in the treatment of no-option chronic limb ischemia patient. CVIR Endovasc 2019;2:26.
Schmidt A, Schreve MA, Huizing E, Del Giudice C, Branzan D, Ünlü Ç, et al
. Midterm outcomes of percutaneous deep venous arterialization with a dedicated system for patients with no-option chronic limb-threatening ischemia: The ALPS multicenter study. J Endovasc Ther 2020;27:658-65.
Ichihashi S, Shimohara Y, Bolstad F, Iwakoshi S, Kichikawa K. Simplified endovascular deep venous arterialization for non-option CLI patients by percutaneous direct needle puncture of tibial artery and vein under ultrasound guidance (AV Spear Technique). Cardiovasc Intervent Radiol 2020;43:339-43.
Cai C, Kilari S, Zhao C, Simeon ML, Misra A, Li Y, et al
. Therapeutic effect of adipose derived mesenchymal stem cell transplantation in reducing restenosis in a murine angioplasty model. J Am Soc Nephrol 2020;31:1781-95.
Cai C, Kilari S, Zhao C, Singh AK, Simeon ML, Misra A, et al
. Adventitial delivery of nanoparticles encapsulated with 1α, 25-dihydroxyvitamin D (3) attenuates restenosis in a murine angioplasty model. Sci Rep 2021;11:4772.
Cai C, Zhao C, Kilari S, Sharma A, Singh AK, Simeon ML, et al
. Experimental murine arteriovenous fistula model to study restenosis after transluminal angioplasty. Lab Anim (NY) 2020;49:320-34.
Singh AK, Cai C, Kilari S, Zhao C, Simeon ML, Takahashi E, et al. 1α,25-dihydroxyvitamin D (3) encapsulated in nanoparticles prevents venous neointimal hyperplasia and stenosis in porcine arteriovenous fistulas. J Am Soc Nephrol 2021; in press.
Karanian JW, Peregoy JA, Chiesa OA, Murray TL, Ahn C, Pritchard WF. Efficiency of drug delivery to the coronary arteries in swine is dependent on the route of administration: Assessment of luminal, intimal, and adventitial coronary artery and venous delivery methods. J Vasc Interv Radiol 2010;21:1555-64.
Razavi MK, Donohoe D, D'Agostino RB Jr., Jaff MR, Adams G; DANCE Investigators. Adventitial drug delivery of dexamethasone to improve primary patency in the treatment of superficial femoral and popliteal artery disease: 12-month results from the DANCE clinical trial. JACC Cardiovasc Interv 2018;11:921-31.
Kokkinidis DG, Armstrong EJ. Current developments in endovascular therapy of peripheral vascular disease. J Thorac Dis 2020;12:1681-94.
Kokkinidis DG, Armstrong EJ. Emerging and future therapeutic options for femoropopliteal and infrapopliteal endovascular intervention. Interv Cardiol Clin 2017;6:279-95.
Zhang L, Xiang Y, Zhang H, Cheng L, Mao X, An N, et al
. A biomimetic 3D-self-forming approach for microvascular scaffolds. Adv Sci (Weinh) 2020;7:1903553.
[Figure 1], [Figure 2], [Figure 3], [Figure 4]