Vascular Stents Research Articles

A Predictive Toxicokinetic Model for Nickel Leaching from Vascular Stents.

In vitro testing methods offer valuable insights into the corrosion vulnerability of metal implants and enable prompt comparison between devices. However, they fall short in predicting the extent of leaching and the biodistribution of implant byproducts under in vivo conditions. Physiologically based toxicokinetic (PBTK) models are capable of quantitatively establishing such correlations and therefore provide a powerful tool in advancing nonclinical methods to test medical implants and assess patient exposure to implant debris. In this study, we present a multicompartment PBTK model and a simulation engine for toxicological risk assessment of vascular stents. The mathematical model consists of a detailed set of constitutive equations that describe the transfer of nickel ions from the device to peri-implant tissue and circulation and the nickel mass exchange between blood and the various tissues/organs and excreta. Model parameterization was performed using (1) in-house-produced data from immersion testing to compute the device-specific diffusion parameters and (2) full-scale animal in situ implantation studies to extract the mammalian-specific biokinetic functions that characterize the time-dependent biodistribution of the released ions. The PBTK model was put to the test using a simulation engine to estimate the concentration-time profiles, along with confidence intervals through probabilistic Monte Carlo, of nickel ions leaching from the implanted devices and determine if permissible exposure limits are exceeded. The model-derived output demonstrated prognostic conformity with reported experimental data, indicating that it may provide the basis for the broader use of modeling and simulation tools to guide the optimal design of implantable devices in compliance with exposure limits and other regulatory requirements.

Vascular covered stent and video-assisted thoracoscopic surgery for Aortoesophageal fistula caused by esophageal fishbone: a case report

BackgroundAortoesophageal fistula (AEF) is a rare condition characterized by communication between the aorta and esophagus. AEF caused by an esophageal foreign body is even rare, and there is currently no recommended standard treatment protocol. We report a case of delayed aortic rupture after the endoscopic removal of a fish bone, which was successfully treated with a combined approach of vascular stenting and thoracic surgery.Case presentationA 33-year-old man presented to the hospital after experiencing chest discomfort for 3 days following the accidental ingestion of a fish bone. Under endoscopic guidance, the fish bone was successfully removed, and the patient was subsequently admitted for medical therapy. On the fourth postoperative day, the patient suddenly developed hematemesis, and chest computed tomography angiography revealed the presence of an AEF. This necessitated urgent intervention; hence, thoracic surgery was performed and a vascular-covered stent was placed. Following the surgical procedure, the patient received active medical treatment, recovered well, and was successfully discharged from the hospital.ConclusionsIn patients with esophageal perforation caused by foreign bodies, hospitalization for observation, computed tomography angiography examination, early use of antibiotics, and careful assessment of aortic damage are advised. Thoracic endovascular aortic repair and esophageal rupture repair may have benefits for the treatment of AEF.

Does central venous stenosis affects the brachial artery flow volume and peripheral vascular resistive index in patients on maintenance hemodialysis? A retrospective study.

A well-functioning vascular access (VA) is crucial for the patients on maintenance hemodialysis (HD). Central venous stenosis (CVS) is a common, yet, overlooked complication of VA as its diagnosis is challenging. Moreover, its effect on the flow volume (FV) and the peripheral resistive index (RI) was not well discussed before. Despite the availability of doppler ultrasound (DUS) in most centers, direct visualization of central veins using DUS is quite difficult. This is a retrospective single-center self-controlled cohort study that was conducted in a specialized vascular access management tertiary center in Japan and included all patients with CVS who underwent percutaneous transluminal angiography (PTA) with or without vascular stenting in the period from January 2014 to September 2022. The patients were divided according to their VA type into arteriovenous fistula (AVF), and arteriovenous graft (AVG) groups, then subdivided, according to the type of stenosis, into two subgroups: CVS, and mixed central and peripheral venous stenosis (MVS) groups. The FV and RI of the feeding artery were compared in the same procedure before and after PTA to assess the impact of the procedure itself. Data of 485 percutaneous transluminal angiography procedures (PTA), performed in 95 patients during the period from January 2014 to September 2022, were collected. FV and RI were significantly affected in the patients with MVS than patients with CVS. After PTA, both FV and RI were significantly improved. The improvement rate of FV and RI after PTA were significantly higher in patients with MVS than patients with CVS. However, it was difficult to determine the cut-off value to diagnose or to assess the improvement of CVS. Our findings suggest that FV and RI measurement by DUS are good tools, along with the clinical findings for assessment of CVS in certain situations.

Efficacy and safety of 3D reconstruction and basket multi-electrode renal denervation (RDN) for refractory hypertensive patients with chronic kidney disease.

Renal Artery Sympathetic Denervation (RDN) can lower blood pressure. Different ablation catheters (single electrode, multi-electrode) have different scopes of ablation (renal artery main stem and branches). Few studies have compared the advantages and disadvantages of different ablation catheters and different procedures in terms of antihypertensive efficacy. To compare the efficacy and safety of 3D reconstruction radiofrequency ablation (3DRA) and basket multi-electrode radiofrequency ablation (BMRA) in Renal Artery Sympathetic Denervation. Fifty-three patients with Refractory hypertension (RHT) were divided into BMRA, (n=28) and 3DRA(n=25). BMRA group used a stereobasket multi-electrode ablation catheter with a controlled ablation temperature of 60°C and an ablation time of 120s per site. 3DRA group used a NavStar pressure-monitored perfusion monopolar ablation catheter with a controlled ablation temperature of 40°C, an ablation time of 40s per site, and an ablation energy of 12W. Baseline and RDN parameters and complications were compared in both groups. Home and 24h ambulatory blood pressure, type of anti-hypertensive medication taken, and serum creatinine were followed up at 1, 3, 6, 12, and 24 months after the RDN. There were no differences in baseline characteristics between the two groups. (23.14±2.00)months of follow-up in the BMRA group resulted in a total of (25.86±8.61) loci ablation. (19.28±7.40)months of follow-up in the 3DRA group resulted in a total of (21.04±6.47)loci ablation. Home SBP was significantly lower in both groups at 1 month after RDN treatment compared to baseline(H-SBP/mmHg: BMRA 149.9±10.59vs. baseline 168.36±12.76; 3DRA 152.6±14.91vs. 164.89±12.96, both p<.05). The proportion of people with 24h ambulatory SBP attainment was significantly higher in both groups and was maintained for 24 months. At each follow-up time point, there were no differences in home and 24-h flow SBP, DBP, or Scr between the two groups. There were two cases of severe renal artery complications from implanted vascular stents and one case of femoral artery pseudoaneurysm in the 3DRA group. At follow-up, 1 (1.9%) patient in the 3DRA group died of unexplained death and 1 (1.9%) patient developed heart failure, and 1 (1.9%) patient in the BMRA group died of unexplained death. Basket multi-electrode radiofrequency ablation and 3D reconstruction radiofrequency ablation of the renal artery applied to RDN have comparable efficacy in reducing systolic blood pressure.

Self-Reinforced PTLG Copolymer with Shish Kebab Structures and a Bionic Surface as Bioimplant Materials for Tissue Engineering Applications.

Green and biodegradable materials with great mechanical properties and biocompatibility will offer new opportunities for next-generation high-performance biological materials. Herein, the novel oriented shish kebab crystals of a novel poly(trimethylene carbonate-lactide-glycolide) (PTLG) vascular stent are first reported to be successfully fabricated through a feasible solid-state drawing process to simultaneously enhance the mechanical performance and biocompatibility. The crystal structure of this self-reinforced vascular stent was transformed from spherulites to a shish kebab crystal, which indicates the mechanical interlocking effect and prevents the lamellae from slipping with a significant improvement of mechanical strength to 333 MPa. Meanwhile, it is different from typical biomedical polymers with smooth surface structures, and the as-obtained PTLG vascular stent exhibits a bionic surface morphology with a parallel micro groove and ridge structure. These ridges and grooves were attributed to the reorganization of cytoskeleton fiber bundles following the direction of blood flow shear stress. The structure and parameters of these morphologies were highly similar to the inner surface of blood vessels of the human, which facilitates cell adhesion growth to improve its proliferation, differentiation, and activity on the surface of PTLG.

Vascular stent with immobilized anti-inflammatory chemerin 15 peptides mitigates neointimal hyperplasia and accelerates vascular healing

Endovascular stenting is a safer alternative to open surgery for use in treating cerebral arterial stenosis and significantly reduces the recurrence of ischemic stroke, but the widely used bare-metal stents (BMSs) often result in in-stent restenosis (ISR). Although evidence suggests that drug-eluting stents are superior to BMSs in the short term, their long-term performances remain unknown. Herein, we propose a potential vascular stent modified by immobilizing clickable chemerin 15 (C15) peptides on the stent surface to suppress coagulation and restenosis. Various characterization techniques and an animal model were used to evaluate the surface properties of the modified stents and their effects on endothelial injury, platelet adhesion, and inflammation. The C15-immobilized stent could prevent restenosis by minimizing endothelial injury, promoting physiological healing, restraining the platelet-leukocyte-related inflammatory response, and inhibiting vascular smooth muscle cell proliferation and migration. Furthermore, in vivo studies demonstrated that the C15-immobilized stent mitigated inflammation, suppressed neointimal hyperplasia, and accelerated endothelial restoration. The use of surface-modified, anti-inflammatory, endothelium-friendly stents may be of benefit to patients with arterial stenosis. Statement of significanceEndovascular stenting is increasingly used for cerebral arterial stenosis treatment, aiming to prevent and treat ischemic stroke. But an important accompanying complication is in-stent restenosis (ISR). Persistent inflammation has been established as a hallmark of ISR and anti-inflammation strategies in stent modification proved effective. Chemerin 15, an inflammatory resolution mediator with 15-aa peptide, was active at picomolar through cell surface receptor, no need to permeate cell membrane and involved in resolution of inflammation by inhibiting inflammatory cells adhesion, modulating macrophage polarization into protective phenotype, and reducing inflammatory factors release. The implications of this study are that C15 immobilized stent favors inflammation resolution and rapid re-endothelialization, and exhibits an inhibitory role of restenosis. As such, it helps the decreased incidence of ISR.

Treatment of symptomatic popliteal artery lesions: An obituary of the GORE® TIGRIS® vascular stent.

The popliteal artery is highly exposed to biomechanical stress, which is the primary factor associated with stent failure. However, information on the optimal endovascular treatment for the popliteal artery is lacking. To report the efficacy of the GORE® TIGRIS® Vascular Stent for the endovascular treatment of popliteal artery lesions. Retrospective analysis of all patients with symptoms of peripheral artery occlusive disease (PAD) and popliteal artery lesions who underwent implantation of a GORE® TIGRIS® Vascular Stent between August 2012 and August 2014 at a tertiary vascular centre. Between August 2012 and August 2014, 48 patients (32 men, aged 75±8 years) were treated with a GORE® TIGRIS® Vascular Stent. The technical success rate was 100%. At 12 months, the primary and secondary patency rates were 74% and 85%, respectively. During follow-up, no stent fracture was observed. No major amputations were performed. Our study showed that isolated popliteal artery lesions in patients with symptomatic PAD could easily be treated with the GORE® TIGRIS® Vascular Stent, as good short-term results were achieved at 12 months. Therefore, the discontinuation of this product removed a useful tool with a simple release mechanism from the endovascular armamentarium of vascular specialists.

Pharmacologic targeting of coagulation factors XII and XI by monoclonal antibodies reduces thrombosis in nitinol stents under flow

BackgroundCardiovascular implantable devices, such as vascular stents, are critical for the treatment of cardiovascular diseases. However, their success is dependent on robust and often long-term antithrombotic therapies. Yet, the current standard-of-care therapies often pose significant bleeding risks to patients. Coagulation factor (F)XI and FXII have emerged as potentially safe and efficacious targets to safely reduce pathologic thrombin generation in medical devices. ObjectivesTo study the efficacy of monoclonal antibody–targeting FXII and FXI of the contact pathway in preventing vascular device–related thrombosis. MethodsThe effects of inhibition of FXII and FXI using function-blocking monoclonal antibodies were examined in a nonhuman primate model of nitinol stent–related thrombosis under arterial and venous flow conditions. ResultsWe found that function-blocking antibodies of FXII and FXI reduced markers of stent-induced thrombosis in vitro and ex vivo. However, FXI inhibition resulted in more effective mitigation of thrombosis markers under varied flow conditions. ConclusionThis work provides further support for the translation of contact pathway of coagulation inhibitors for their adjunctive clinical use with cardiovascular devices.

Scaffolds with a Tunable Nonlinear Elastic Region Using a Corrugated Design

Elastin is the main component of arteries and is responsible for their high‐elastic high‐strain capacity. The biomechanics of biological tissues typically display a stress–strain curve characterized by a sigmoidal shape that has an initial region with low stress and high strain. Studies aimed at mimicking such biomechanical behavior focus on improving the synthesis of elastin or replicating elastin behavior, which proves to be a continuous challenge. Alternatively, scaffolds' architecture can potentially mimic the sigmoidal stress–strain curve of tissues. Hence, the aim of this study was to replicate the stress–strain curve of a carotid artery using a tailorable corrugated design. Results showed that the corrugated design unfolded during extension without generating significant stress and displayed a sigmoidal stress–strain curve that could be controlled depending on the corrugation features. Editing the amount of fibers resulted in a different Young's modulus, while the amplitude of the fibers and the amount of repeating units influenced the initial nonlinear region of the stress–strain curve. Scaffolds made of poly(ε‐caprolactone) (PCL) and poly(ethylene oxide terephthalate)/poly(butylene terephthalate (PEOT/PBT) were compared to determine the applicability of the design principles to different biodegradable polymers that normally do not have the same biomechanical behavior of soft tissues like arteries. The optimized designs had a similar stress–strain curve within the physiological range as porcine arteries. The corrugated design can serve as a biomimicry approach for vascular grafts or an alternative to vascular stents.

Effect of trimethylene carbonate segments on the structure and properties of poly(L‐lactide‐glycolide‐trimethylene carbonate) terpolymers for biodegradable vascular stents

AbstractThe total biodegradable vascular stent made of poly(L‐lactide‐glycolide‐trimethylene carbonate) terpolymers with excellent performances has the potential to be used in a new generation of medical implant devices. In this work, the properties and structure of terpolymers were investigated, which were found to be controlled by the composition of the copolymer chain. The amorphous trimethylene carbonate segments not only disturbed the sequence regularity of the L‐lactide segment, but also reduced the crystallization ability of the material. Furthermore, it is the flexible segments in the terpolymer chains that improve the plastic flow capacity, increase the flexibility of chains as well as reduce the apparent activation energy of thermal degradation of materials. Such a chain structured terpolymer exhibited good extrudability and buildability in 3D printing and formed a vascular stent with a cohesion entanglement characteristic microstructure during the process. The crush resistance with radially applied load and crush resistance with parallel plates of stent were 2561.4 mm Hg and 0.24 N/mm, respectively.

Polyvinylpyrrolidone-stabilised gold nanoparticle coatings inhibit blood protein adsorption

Abstract In this work, the ability of polyvinylpyrrolidone (PVP)-stabilised gold nanoparticle (AuNP) coatings to inhibit blood protein adsorption was evaluated by studying time-resolved solid–liquid interactions of the coatings with the model blood protein bovine serum albumin (BSA). Inhibiting unspecific blood protein adsorption is of crucial importance for blood-contacting implant devices, e.g. vascular grafts, stents, artificial joints, and others, as a preventive strategy for bacterial biofilm formation. A quartz crystal microbalance was used in this work to coat the AuNPs on piezoelectric sensors and to follow time-resolved solid–liquid interactions with the proteins. The AuNP coatings were evaluated for their wettability by contact angle measurements, their surface morphology by light- and atomic force microscopy, and their chemical composition by energy-dispersive X-ray spectroscopy. Results revealed a homogeneous distribution of AuNPs on the sensor surface with a dry mass coverage of 3.37 ± 1.46 µg/cm2 and a contact angle of 25.2 ± 1.1°. Solid–liquid interaction studies by quartz crystal microbalance showed a high repellence of BSA from the PVP-stabilised AuNP coatings and the importance of the PVP in the mechanism of repellence. Furthermore, the conformation of the polymer on the coatings as well as its viscoelastic properties were revealed. Finally, the activated partial thrombin time test and fibrinogen adsorption studies revealed that the AuNPs do not accelerate blood coagulation and can partially inhibit the adhesion of fibrinogen, which is a crucial factor in the common blood coagulation cascade. Such AuNPs have the potential to be used in blood-contact medical applications.

A phenomenological model of pulsatile blood pressure-affected degradation of polylactic acid (PLA) vascular stent.

The stent implantation may alter the post-operative patient's blood pressure, and bioresorbable vascular stents (BVS) as a candidate to treat vascular diseases, its degradation is affected by mechanical stress, thus, the altered pressure representing varying stress level will result in different degradation behaviors of the BVS. This paper first proposed a novel stress-regulated PLA degradation model that included swelling factor, and then the degradation evolutions of a PLA BVS within 180days under normal and high blood pressures were simulated by finite element method, and more four degradation indexes were defined to study the effects of the two blood pressures on the degradation of the PLA BVS. The results showed that the high pressure weakly accelerated the degradation of the PLA BVS with respect to the normal pressure by examining the four indexes, e.g., the residual stent volume decreased to 0.72 and 0.69, respectively for the normal and high pressures at day 180. The current finding provided a theoretical understanding of the PLA BVS degradation, and hinted that the PLA BVS may not need to be elaborately selected in clinical practices for treating hypertensive patients.

A Versatile Passivated Protein‐Adsorption Platform for Rapid Healing of Vascular Stents by Modulating the Microenvironment

AbstractBiodegradable stents have paved the way to treat coronary artery disease. However, rapid reendothelialization is required to solve the problems of mismatched degradation rates, localized inflammation, and insufficient biocompatibility. Herein, a novel passivated protein‐adsorption coating is synthesized by coordination chelation, oxidation, cross‐linking, polymerization, and deposition of dopamine, (‐)‐epigallocatechin gallate (EGCG), and copper ions (Cu2+) using two‐electron oxidation. This coating exhibits hierarchical functionality, that is, at the macroscale, its superhydrophilicity conveys antifouling ability; whereas at the microscale, the active groups (quinone‐, amino‐, hydroxyphenyl groups and aromatic ring) facilitate protein adsorption. Antifouling ability prevents acute thrombosis and inflammation and maintains initial microenvironment stability post‐implantation. The active groups facilitate gradual endothelial cells (ECs) adhesion. Meanwhile, the decomposition of nitric oxide (NO) donors to release NO is catalyzed by Cu2+, and EGCG alleviates or prevents oxidative stress damage, inflammatory responses, thrombosis formation, and excessive smooth muscle cells proliferation in the stent microenvironment. This provides favorable conditions for the rapid and healthy growth of ECs. This study proposes a novel strategy for rapid neointima formation comprising healthy ECs on the surfaces of biodegradable stents by depositing a passivated protein‐adsorption coating (polydopamine/EGCG/Cu), opening new possibilities for the efficient treatment of coronary artery disease.

To the issue of the analysis of vascular stents purchase

To the issue of the analysis of vascular stents purchase

Wavelet-based U-shape network for bioabsorbable vascular stents segmentation in IVOCT images.

Coronary artery disease remains a leading cause of mortality among individuals with cardiovascular conditions. The therapeutic use of bioresorbable vascular scaffolds (BVSs) through stent implantation is common, yet the effectiveness of current BVS segmentation techniques from Intravascular Optical Coherence Tomography (IVOCT) images is inadequate. This paper introduces an enhanced segmentation approach using a novel Wavelet-based U-shape network to address these challenges. We developed a Wavelet-based U-shape network that incorporates an Attention Gate (AG) and an Atrous Multi-scale Field Module (AMFM), designed to enhance the segmentation accuracy by improving the differentiation between the stent struts and the surrounding tissue. A unique wavelet fusion module mitigates the semantic gaps between different feature map branches, facilitating more effective feature integration. Extensive experiments demonstrate that our model surpasses existing techniques in key metrics such as Dice coefficient, accuracy, sensitivity, and Intersection over Union (IoU), achieving scores of 85.10%, 99.77%, 86.93%, and 73.81%, respectively. The integration of AG, AMFM, and the fusion module played a crucial role in achieving these outcomes, indicating a significant enhancement in capturing detailed contextual information. The introduction of the Wavelet-based U-shape network marks a substantial improvement in the segmentation of BVSs in IVOCT images, suggesting potential benefits for clinical practices in coronary artery disease treatment. This approach may also be applicable to other intricate medical imaging segmentation tasks, indicating a broad scope for future research.

Mechanical analysis of radial performance in biodegradable polymeric vascular stents manufactured using micro-injection molding

Micro-injection molding (MiM) is a promising technique for manufacturing biodegradable polymeric vascular stents (BPVSs) at scale, in which a trapezoidal strut cross section is needed to ensure high-quality de-molding. However, there is a lack of research on the influence of the strut cross-sectional shape on its mechanical properties, posing a challenge in determining the key geometries of the strut when using MiM to produce BPVSs. Hence, this work has investigated the relationships between the geometry parameters, including the de-molding angle, and the radial support property of BPVSs using the finite element method. The results reveal that the radial stiffness of BPVSs is significantly affected by the de-molding angle, which can be counteracted by adjusting strut height, bending radius, and strut thickness. Stress distribution analysis underscores the crucial role of the curved portion of the support ring during compression, with the inner side of the curved region experiencing stress concentration. A mathematical model has been established to describe the relationships between the geometry parameters and the radial support property of the BPVSs. Notably, the radius of the neutral layer emerges as a key determinant of radial stiffness. This study is expected to serve as a guideline for the development of BPVSs that can be manufactured using MiM.

Construction and biocompatibility evaluation of MOF/S-HA composite coating on the surface of magnesium alloy vascular stent

In recent years, functional molecules such as metal-organic frameworks (MOFs), hyaluronic acid (HA) and heparin have been widely studied in the field of surface modification of cardiovascular and cerebrovascular implant materials. However, magnesium (Mg) alloy scaffolds, which are used as implanted materials, have difficulties such as poor cell compatibility, insufficient endothelialization, and remodeling of the blood–brain barrier. In this study, MOF-Cu formed after chelating organic ligand catechol (HPT) and Cu(II) was coated by Sulfonated hyaluronic acid (S-HA) on the surface of ZE21B Mg alloy to form a composite coating, which not only inherited the excellent anticoagulant and anti-inflammatory properties of S-HA, but also significantly improved the bio-compatibility of the coating by reasonably regulating the concentration of Nitric oxide (NO) catalytic release, promoted the proliferation, migration and expression of specific factors in endothelial cells (ECs), regulated the transformation of smooth muscle cells (SMCs) to contractile phenotypes. And it has important and remarkable performance in promoting the transformation of macrophage (MA) into anti-inflammatory M2 phenotype. These results provide important research strategies for Mg alloy vascular stents materials in remodeling blood–brain barrier, relaxing cerebrovascular vessels, inhibiting inflammatory responses, and maintaining cardiovascular and cerebrovascular elasticity.

Comparison of properties of cardiac vascular stent materials

Cardiovascular disease (CVD) is a serious threat to human health and life, an important public safety issue, and one of the leading causes of death in the world. Typically, the treatment involves implanting stents in the patient's blood vessels to support the vessels and keep the blood flow open so that oxygen and nutrients can be delivered. This paper will discuss and compare the three main categories of vascular stent materials: 1) organic materials; 2) inorganic materials; and 3) composite materials. Existing bio-organic materials are mostly organic materials that exist in large quantities in the human body and are mostly used as bio-coatings applied to metal bodies, in addition to polyester cardiovascular scaffolds, which are a major category for future development. Inorganic materials are currently the main components of cardiovascular scaffolds, mainly metals, and bio-ceramics. Metals, as the earliest basic materials utilized by mankind, also play a major role in cardiovascular scaffolds. To enhance some specific properties of existing cardiovascular scaffolds, composite materials have been developed, and in the field of materials engineering composite materials are regarded as a major project for future development. This paper will discuss the advantages and disadvantages of each material in turn and explore the future direction of materials in this field. The development of cardiac vascular stent materials will make up for the deficiencies in clinical medicine that cannot be solved by drug-based therapies and is an indispensable part of the development of human science and technology.

Risk of spinal surgery among individuals who have been re-vascularized for coronary artery disease

HypothesisRevascularization is a more effective intervention to reduce future postop complications. MethodsPatients undergoing elective spine fusion surgery were isolated in the PearlDiver database. Patients were stratified by having previous history of vascular stenting (Stent), coronary artery bypass graft (CABG), and no previous heart procedure (No-HP). Means comparison tests (chi-squared and independent samples t-tests, as appropriate) compared differences in demographics, diagnoses, and comorbidities. Binary logistic regression assessed the odds of 30-day and 90-day postoperative (postop) complications associated with each heart procedure (Odds Ratio [95 % confidence interval]). Statistical significance was set p < 0.05. Results731,173 elective spine fusion patients included. Overall, 8,401 pts underwent a CABG, 24,037 pts Stent, and 698,735 had No-HP prior to spine fusion surgery. Compared to Stent and No-HP patients, CABG patients had higher rates of morbid obesity, chronic kidney disease, and diabetes (p < 0.001 for all). Meanwhile, stent patients had higher rates of PVD, hypertension, and hyperlipidemia (all p < 0.001). 30-days post-op, CABG patients had significantly higher complication rates including pneumonia, CVA, MI, sepsis, and death compared to No-HP (all p < 0.001). Stent patients vs. No-HF had higher 30-day post-op complication rates including pneumonia, CVA, MI, sepsis, and death. Furthermore, adjusting for age, comorbidities, and sex Stent was significantly predictive of a MI 30-days post-op (OR: 1.90 [1.53–2.34], P < 0.001). Additionally, controlling for levels fused, stent patients compared to CABG patients had 1.99x greater odds of a MI within 30-days (OR: 1.99 [1.26–3.31], p = 0.005) and 2.02x odds within 90-days postop (OR: 2.2 [1.53–2.71, p < 0.001). ConclusionWith regards to spine surgery, coronary artery bypass graft remains the gold standard for risk reduction. Stenting does not appear to minimize risk of experiencing a post-procedure cardiac event as dramatically as CABG.

Dealloyed nano-porous Ti[sbnd]Cu coatings with controlled copper release for cardiovascular devices

TiCu coatings with controlled copper release and nano-porous structures were fabricated as biocompatible, blood-contacting interfaces through a two-step process. Initially, coatings with 58 % Cu were created using HiPIMS/DC magnetron co-sputtering, followed by immersion in a dilute HF solution for varying durations to achieve dealloying. The presence of Ti elements in the as-deposited TiCu coatings facilitated their dissolution upon exposure to the dilute HF solution, resulting in the formation of nanopores and increased nano-roughness. Dealloying treatment time correlated with higher Cu/(Ti + Cu) values, nanopore size, and nano-roughness in the dealloyed samples. The dealloyed TiCu coatings with 87 % Cu exhibited a controlled release of copper ions and displayed nanopores (approximately 80 nm in length and 31.0 nm in width) and nano-roughness (Ra roughness: 82 nm). These coatings demonstrated inhibited platelet adhesion and suppressed smooth muscle cell behavior, while supporting favorable endothelial cell viability and proliferation, attributed to the controlled release of copper ions and the extent of nanostructures. In contrast, the as-deposited TiCu coatings with 85 % Cu showed high copper ion release, leading to decreased viability and proliferation of endothelial cells and smooth muscle cells, as well as suppressed platelet adhesion. The TiCu coatings met medical safety standards, exhibiting hemolysis rates of <5 %. The technology presented here paves the way for the simple, controllable, and cost-effective fabrication of TiCu coatings, opening new possibilities for surface modification of cardiovascular devices such as vascular stents and inferior vena cava filters.