Covered stents: A review

doi:10.1016/j.ijcard.2008.04.083

International Journal of Cardiology

Volume 130, Issue 3, 28 November 2008, Pages 310-318

https://doi.org/10.1016/j.ijcard.2008.04.083 Get rights and content

Abstract

Stents are the most important advance for percutaneous coronary revascularization. After introduction of drug eluting stents, in-stent restenosis ist not more a major problem of coronary intervention. However, restenosis by bare metal stents, peripheral embolism following stent implationtan in old vein grafts, and conditions in which there is a discontinuity of the coronary lumen (rupture or perforation, aneurysm, and fistula) remain a problem in interventional therapy. Stent grafts with integration of a membrane into a coronary stent represent an interesting concept to possibly prevent intraluminal proliferation, to seal degenerated vein grafts, and to cover coronary artery perforations, symptomatic aneurysms, and fistula with high success and acceptable rates of acute complications. We presents case reports and a review article.

Introduction

Stents are the most important advance for percutaneous coronary revascularization. After introduction of drug eluting stents, in-stent restenosis is not more a major problem of coronary intervention. However, restenosis by bare metal stents, peripheral embolism following stent implantation in old vein grafts, and conditions in which there is a discontinuity of the coronary lumen (rupture or perforation, aneurysm, and fistula) remain a problem in interventional therapy. Stent grafts with integration of a membrane into a coronary stent represent an interesting concept to possibly prevent intraluminal proliferation, to seal degenerated vein grafts, and to cover coronary artery perforations, symptomatic aneurysms, and fistula with high success and acceptable rates of acute complications [1].

Section snippets

History of development

The advent of coronary stents led to a dramatic reduction in procedure-related complications (e.g., acute closure) and markedly improved long-term outcome. Nonetheless, percutaneous interventions with bare metal stents are still limited by the persistent problem of restenosis. Depending on stent geometry, tissue prolapse through the metal mesh may contribute to restenosis, yet the predominant mechanism of in-stent restenosis is neointimal proliferation. The wall injury inherent to any coronary

Coronary perforation

Coronary artery perforation is an infrequent but well-recognized complication of percutaneous transluminal interventions, reported to occur in 0.1%–3.0% of endovascular interventions. Oversized balloons, high inflation pressures, stiff guide wires, and debulking devices are likely to be causal factors resulting in potential life-threatening complications such as hemopericardium, cardiac tamponade, and myocardial infarction [7].

Other risk factors are calcified, tortuous and non-compliant

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Cited by (54)

Inflammation-directed nanozyme-eluting hydrogel coating promotes vascular tissue repair by restoring reactive oxygen species homeostasis
2023, Chemical Engineering Journal
Thrombosis and stenosis remain two of the most prevalent complications of vascular implants. The most effective strategy in clinics to inhibit stenosis is based on the eluting of anti-hyperplasia drugs such as sirolimus and everolimus while it also has been known to hinder vascular healing and regeneration. Selectively inhibiting intimal hyperplasia and promoting endothelialization remains a highly challenging target for vascular implants. Due to auto-regenerative antioxidant activity nanoceria as a nanozyme has been widely used to regulate oxidative stress in the treatment of inflammation-related diseases. Yet the application of nanozyme in vascular implants has not hitherto been reported. In this study we constructed a reactive oxygen species (ROS)-targeted nanoceria-eluting degradable zwitterion hydrogel coating on membrane-covered stents with favorable anti-coagulation pro-endothelialization and immunomodulation properties. The hydrogel coating exhibited excellent hemocompatibility and simultaneously promoted the growth of endothelial cells. Nanoceria embedded in hydrogel could be released in response to matrix metalloproteinase (MMP) and effectively scavenge artificial and intracellular ROS via mimicking the activity of natural superoxide dismutase (SOD) and catalase (CAT). In addition the incorporation of nanoceria increased the expression levels of anti-inflammation cytokines and growth factors and reduced the expression levels of pro-inflammation cytokines in macrophages inducing a switch of macrophage phenotype from M1 to M2. The membrane-covered stent based on nanozyme-integrated hydrogel-coated PLLA membrane exhibited a high patency rate and slight intima hyperplasia degree upon implantation into rabbits' iliac arteries/abdominal aortas. This advanced hydrogel coating may provide a new low-cost and drug-free strategy for effectively inhibiting vascular stenosis and promoting vascular repair.
From the Aortic Bifurcation to the Groin: Long-term Outcomes of Covered Kissing Stent Placement in Combination with Iliofemoral Reconstruction for Extensive Iliofemoral Occlusive Disease
2020, Annals of Vascular Surgery
The aim of this study was to evaluate outcomes of extensive iliofemoral reconstruction combining both iliac covered kissing stents (ICKS) with stenting of the external iliac artery (SEIA) and/or surgical femoral endarterectomy (SFE).
From November 2010 to November 2017, patients with extensive iliofemoral occlusive disease—classified as Trans-Atlantic Inter-Society Consensus class D—treated by ICKS in combination with SEIA and/or SFE were included. Patients received ICKS + SEIA, ICKS + SFE, or ICKS + SEIA + SFE. Demographics, procedure details, and postoperative outcomes were recorded. Primary end points were primary patency (PP), primary assisted patency (PAP), and secondary patency (SP). Long-term patency was assessed by annual clinical and ultrasonographic examination.
Among 156 consecutive ICKS procedures performed during the study period, 59 patients were included (81% men; median age, 65 years). In all, 32 patients (54%) underwent ICKS + SEIA, 17 (29%) patients underwent ICKS + SFE, and 10 (17%) patients underwent ICKS + SEIA + SFE. Operative indication was either disabling claudication (n = 46, 78%) or critical limb-threatening ischemia (n = 13, 22%). A total of 92 limbs were revascularized, including 121 covered balloon-expandable stents and 65 self-expanding nitinol stents, with 100% technical success. Thirty-day mortality was 3% (2/59) and 5 (8%) patients suffered from local complications, with no early reintervention. Long-term patency rates were as follows: at 2 years, overall PP, PAP, and SP were 82%, 86%, and 96%, respectively; at 5 years, overall PP, PAP, and SP were 73%, 79%, and 95%, respectively. After a mean follow-up of 34 ± 29 months, 25% (15/59) patients underwent late reinterventions for either de novo iliac or femoral stenosis (n = 9), iliac occlusion (n = 4), or external iliac in-stent restenosis (n = 2).
Treatment of extensive iliofemoral occlusive disease involving ICKS in combination with SEIA and/or SFE is safe and effective, providing satisfactory long-term secondary patency, at the price of a significant reintervention rate.
Layer-by-layer biofabrication of coronary covered stents with clickable elastin-like recombinamers
2019, European Polymer Journal
Coronary artery disease is the leading cause of death around the world. Endovascular stenting is the preferred treatment option to restore blood flow in the coronary arteries due to the lower perioperative morbidity when compared with more invasive treatment options. However, stent failure is still a major clinical problem, and further technological solutions are required to improve the performance of current stents. Here, we developed coronary stents covered with elastin-like recombinamers (ELRs) by exploiting a layer-by-layer technique combined with catalyst-free click chemistry. The resulting ELR-covered stents were intact after an in vitro simulated implantation procedure by balloon dilatation, which evidenced the elastic performance of the membrane. Additionally, the stents were mechanically stable under high flow conditions, which is in agreement with the covalent and stable nature of the click chemistry crosslinking strategy exploited during the ELR-membrane manufacturing and the successful embedding of the stent. Minimal platelet adhesion was detected after blood exposure in a Chandler loop as shown by scanning electron microscopy. The seeding of human endothelial progenitor cells (EPCs) on the ELR-membranes resulted in a confluent endothelial layer. These results prove the potential of this strategy to develop an advanced generation of coronary stents, with a stable and bioactive elastin-like membrane to exclude the atherosclerotic plaque from the blood stream or to seal coronary perforations and aneurysms, while providing a luminal surface with minimal platelet adhesion and favouring endothelialization.
Coronary bypass graft perforation during percutaneous intervention
2016, Cardiovascular Revascularization Medicine
Coronary artery bypass grafts are prone to accelerated atherosclerosis and as such graft stenosis is frequently encountered in clinical practice. Complications specific to graft- PCI include no-reflow, distal embolization, stent restenosis and thrombosis. Graft perforation during PCI is a rare coomplication of the procedure. Published literature on the predictors of perforation and management strategy remains limited to anecdotal cases.
In this review we collected data on all cases of graft perforations reported in PubMed/Medline from 1987 to 2015.
37 cases of graft perforation were reported. High risk grafts for perforations included, old grafts (14 ± 7.8 years) with more than 80% luminal stenosis. Perforations were noted after use of different cardiac devices and included stent placement (30%, N=11), balloon angioplasty (36%, N=14), post-dilation with non complaint balloon (16%, N=6), guide wire perforation (1 case), post IVUS imaging (1 case) and one case after use of thrombus extraction device. Average stent diameter of 3.7 ± 0.7 mm, average balloon pressure of 15.5 ± 5 atm and 3 or more balloon inflations commonly resulted in graft perforation.
78% of cases reported class III perforation. Covered stent implantation was strongly associated with controlling acute bleed after graft perforation than prolonged balloon inflation (p = 0.0001). Majority of cases reported using covered stents (81%). Average stent diameter of 3.9 ± 0.7 mm, average stent length of 18.5 ± 6 mm and the average deployment pressure of 14 ± 2 atm were reported to be effective in controlling the bleed.
95% of the patients did well post procedure and with prolonged hospitalization (8 ± 4 days). 24% of cases reported cardiac tamponade causing hemodynamic compromise including 2 peri-procedural deaths.
Graft perforation can be effectively treated with covered stent grafts with good immediate results, short term outcome and acceptable peri-procedural risks.
Next generation covered stents made from nanocomposite materials: A complete assessment of uniformity, integrity and biomechanical properties
2016, Nanomedicine: Nanotechnology, Biology, and Medicine
Covered stents are stents wrapped with a thin polymeric membrane, and are typically used to treat vessel aneurysms and seal perforated arteries. Current covered stents suffer from restenosis due to limitations in material and fabrication methods which leaves metallic struts directly exposed to blood. We have developed a biocompatible and haemocompatible nanocomposite polymer, polyhedral oligomeric silsesquioxane poly(carbonate-urea) urethane (POSS-PCU). We devised a novel combination of ultrasonic spray atomisation system and dip-coating process to produce small calibre covered stents with metal struts fully embedded within the membrane, which also yields greater coating uniformity. Stent-polymer bonding was enhanced via silanisation and coating of reactive pre-polymer. Platelet studies supported the non-thrombogenicity of POSS-PCU. Biomechanical performances including diametrical compliance, bending strength, radial strength and recoil were evaluated and optimised. This proof-of-principle manufacturing technique could lead to the development of next-generation small calibre adult and paediatric covered stents. These stents are currently undergoing preclinical trial.
The use of stents to treat vascular diseases is now the standard of care in the clinical setting. Nonetheless, a major problem of the current stents is the risk of restenosis and thrombosis. The authors developed a nanocomposite material using polyhedral oligomeric silsesquioxane and poly(carbonate-urea) urethane (POSS-PCU) and incorporated into metallic stents. Preliminary data have already shown promising results. It is envisaged that this would further lead to better stent technology in the future.
Preventing in-stent restenosis using lipoprotein (a), lipid and cholesterol adsorbent materials
2015, Medical Hypotheses
Citation Excerpt :
The covered stents are still undergoing under development in design as well as materials used. A covered stent is a stent which is covered by a thin sleeve membrane such as PTFE [5], PET [6], PU [7], POSS-PCU [8], PVA [9] and chitosan [5], that can have positive effects like reduce incidence of ISR; and it also could be a carrier for drugs. In-stent restenosis is a major drawback of stent implantation.
Atherosclerosis is one of the major cause of mortality in developed countries. The characteristic lesion of atherosclerosis is the atheroma or plaque that forms through thickening of the inner layer of the vessel wall (called the intima). The development of stent in 1980s revolutionised treatment of cardiovascular diseases, including atherosclerosis. However the advent of stenting was hindered by the new problem of in-stent restenosis. It was demonstrated that in-stent restenosis was the result of a new pathology in the form of neointimal hyperplasia, which was a maladaptive healing response to bare-metal stent implantation. Recent evidence suggests that although drug-eluting stent (DES) have reduced restenosis rates, important concerns have been raised regarding increased late stent thrombosis, myocardial infarction and death. With advances in nanotechnology and smart materials, covered stents has been proposed to overcome this problem. This is due to in-stent late restenosis and thromboses are mainly caused by smooth muscle cells (SMC) proliferation. Studies showed that there is a relation between high low-density lipoprotein (LDL) and lipoprotein (a) [Lp(a)] level in blood stream and chance of in-stent restenosis, moreover studies show that Lp(a) could stimulate SMC proliferation. We hypothesis development of covered stent with novel design and use of smart materials which could adsorb cholesterol and prevent contact between Lp(a) and vessel wall to overcome problem indicated in DES. In addition cost of stents will significantly reduce by elimination of drugs as well as complex manufacturing of the drug incorporation.

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ReviewCovered stents: A review

Abstract

Introduction

Section snippets

History of development

Coronary perforation

Am J Cardiol

JVIR

Inter J Cardiol

Am J Cardiol

Am J Cardiol

Int J Cardiol

J Vasc Interv Radiol

CHEST

Cardiovasc Surg

J Urol

J Vasc Surg

J Vasc Interv Radiol

Am Heart J

J Surg Res.

J Am Coll Cardiol

Polytetrafluoroethylene-covered stents: indications, advantages, and limitations

J Interv Cardiol

Stents wrapped in autologous vein: an experimental study

J Am Coll Cardiol

autologous vein graft-coated stents for the treatment of thrombus-containing coronary artery lesions

Cath Cardiovasc Diagn

Total reconstruction of a diseased saphenous vein graft by means of conventional and autologous tissue-coated stents

Cath Cardiovasc Diagn

Results of the Jostent coronary stent graft implantation in various clinical settings: procedural and follow-up results

Cath Cardiovasc Inter

Emergency polytetrafluoroethylene-covered stent implantation to treat coronary ruptures

Circulation

Left internal mammary artery graft perforation repair using polytetrafluoroethylene-covered stents

Catheter Cardiovasc Interv

Repair of coronary artery perforation after rotastenting by implantation of the Jostent covered stent

Catheter Cardiovasc Diagn

Early clinical experience with the implantation of a novel synthetic coronary stent graft

Catheter Cardiovasc Diagn

Successful closure of a coronary vessel rupture with a vein graft stent: case report

Catheter Cardiovasc Diagn

Iatrogenic fistula between the left anterior descending coronary artery and anterior interventricular vein following stenting

J Invasive Cardiol

Review
Covered stents: A review