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There is limited data on the optimal revascularization strategy in patients with recurrent in-stent restenosis (R-ISR).To compare the long-term outcomes of patients treated with either a thin-strut drug-eluting stent (thin-DES) or a drug-eluting balloon (DEB) for R-ISR in a drug-eluting stent (DES).A multicenter DEB-DRAGON registry was used to retrospectively identify patients with R-ISR who received either a thin-DES or a DEB. Propensity score matching was applied to adjust for baseline differences. The primary outcome was target lesion revascularization (TLR).Out of 311 patients (mean age, 67 years; 63% male) with R-ISR, 86 (27.7%) were treated with a thin-DES and 225 (72.3%) with a DEB. Median follow-up was 2.6 years. TLR occurred in 18 (20.9%) patients who received thin-DES and 61 (27.1%) patients treated with DEB (hazard ratio [HR], 0.57; 95% confidence interval [CI], 0.33-0.98; log-rank P = 0.04). The difference remained significant in a propensity score-matched cohort of 57 patients treated with thin-DES and 57 patients treated with a DEB (17.5 vs. 33.3%, respectively; HR, 0.38; 95% CI, 0.17-0.86; P = 0.01). The risks of device-oriented adverse cardiac events and all-cause mortality were similar after thin-DES or DEB in both unadjusted and propensity score-matched cohorts. In a multivariable Cox proportional hazard model, the treatment with a thin-DES was an independent predictor of a TLR-free survival (HR, 0.33; 95% CI 0.13-0.84; P = 0.02).In patients with R-ISR implantation of a thin-DES is associated with a lower risk of repeated revascularization compared with angioplasty with a DEB.

Drug-coated balloon (DCB) angioplasty for side branches with main branch stenting is effective for bifurcation lesions and reduces late lumen loss (LLL) in side branches. However, the predictors and clinical implications of LLL after DCB angioplasty are largely unexplored.Among 181 patients undergoing DCB angioplasty for side branches with drug-eluting stent implantation for main branches between 2016 and 2018, we enrolled 138 patients (138 lesions) undergoing follow-up coronary angiography within 1 year. The 1-year cumulative rates of target lesion revascularization (TLR) and major adverse cardiac events (MACE: defined as a composite of all-cause death, myocardial infarction, and TLR) were compared between patients with late lumen gain (LLG) (LLG group) and those with LLL (LLL group).The binary restenosis rate of the side branch was 8.0% (11 lesions), mean LLL was -0.14 ± 0.43 mm, and LLG was observed in 99 lesions (71.7%). The DCB size/reference vessel diameter ratio showed mild discrimination (area under the curve, 0.60; 95% confidence interval, 1.2-65.0; p = 0.03) for predicting the side branch progression. The 1-year cumulative rates of MACE and TLR were not significantly different but numerically lower in the LLG group than in the LLL group (2.0% vs. 7.8%, p = 0.11 and 2.0% vs. 7.7%, p = 0.11, respectively). Lumen regression after DCB angioplasty for side branches are associated with improved clinical outcomes.The DCB size relative to the reference vessel diameter is a predictor of late lumen enlargement in side branches.

Biofilm is a microbiome complex comprising different bacterial colonies that typically adhere to device surfaces in water, which causes serious medical issues such as indwelling infections and outbreaks. Here, we developed a non-nanoparticle, flexible anti-biofilm hygiene coating consisting of lithocholic acid (LCA), zinc pyrithione (Zn), and cinnamaldehyde (Cn) (named as LCA-Zn-Cn) that largely prevents the bacteria adhesion to various water device surfaces such as stainless steel and glass through a synergistic mechanism. The existing chelated groups on LCA and Cn attract plenty of bacteria via hydrophobic interaction. Both the bactericidal reaction by grafting biocidal groups from both LCA and Cn and the bacteriostatic reaction by inhibiting cell division via zinc ions (Zn) lead to a largely improved bacteria/biofilm prevention. The antibacterial performance was assessed by using the JIS Z 2801/ISO 22196 method. The designed LCA-Zn-Cn coating displayed log

Purpose Data on the long-term safety and effectiveness of drug-coated balloons (DCBs) for the treatment of long femoropopliteal atherosclerotic lesions in the real-world setting are rare. This study reports 3 year and 5 year outcomes of the pre-specified 150 mm balloon sub-cohort of the IN.PACT Global Study. Methods The IN.PACT Global Study was a prospective, multicentre, international, single-arm study evaluating the performance of the IN.PACT Admiral DCB in real-world patients with femoropopliteal atherosclerotic disease. This pre-specified 150 mm DCB cohort analysis comprised 107 participants (111 lesions) with all target lesions treated with at least one 150 mm DCB. Results Mean lesion length was 20.3 ± 9.2 cm; 18.0% had in-stent restenosis, 58.6% were totally occluded, and 17.1% were severely calcified. Through 60 months, the Kaplan–Meier estimate of freedom from clinically driven target lesion revascularization (CD-TLR) was 72.7% [95% confidence interval (CI):62.4%–80.5%]. The safety composite endpoint (freedom from device/procedure-related death through 30 days; freedom from target limb major amputation and clinically driven target vessel revascularization through 5 years) was 70.5%. The cumulative incidence of major amputation was 1.0% and all-cause mortality was 18.4% through 60 months. Freedom from CD-TLR rates in the provisional stented and non-stented subgroups through 36 months were 64.0% [95% CI: 46.1%–77.3%] and 81.9% [95% CI: 69.7%–89.6%] (log-rank p = 0.074), respectively. Conclusions The results demonstrate sustained long-term safety of the 150 mm IN.PACT Admiral DCB for long femoropopliteal atherosclerotic lesions in real-world patients. In particular, the results show that DCB angioplasty is an effective revascularization modality in long complex lesions. ClinicalTrials.gov identifier: NCT01609296. Level of Evidence. Level 3, Cohort Study.

Purpose To investigate drug contamination of the working environment with paclitaxel drug-coated balloon (DCB) angioplasty due to loss of paclitaxel containing particles from the coating during DCB preparation, insertion, and inflation. Material and Methods In an experimetal laboratory setting, drug loss during removal of the protective cover and insertion of the DCB through the hemostatic valve of the introducer sheath and after inflation was examined. In seven DCB types of different manufacturers, semi-quantitative image analysis was performed during five standardized tests cycles. Additionally, every DCB type passed one cycle of a wipe test and one cycle of air sampling. Results By removing the protective cover, the paclitaxel-covered balloon surface was significantly reduced in 3 out of 7 products (P = 0.043). Overall, extend of decline ranged from 0.4 to 12%. In 6 of 7 products, powdered paclitaxel clusters dropped down upon removal of the protective cover (0.099 ng/cm2 up to approx. 22 ng/cm2). Contamination of the air was detected in none of the DCB types. When pushed through the vascular sheath, none of the investigated DCB types showed a significant loss of paclitaxel from the coated balloon surface. After balloon inflation, the paclitaxel-coated surface area varied between manufacturers ranging from 25.9 to 97.8%. Conclusion In some DCB types, the removal of the protective cover already leads to a significant loss of paclitaxel and paclitaxel-coated surfaces. As a result, there will be a contamination of the workplace and a reduction in the therapeutic dose. Level of Evidence No level of evidence.

While roughening the surface of neural implants has been shown to significantly improve their performance, the mechanism for this improvement is not understood, preventing systematic optimization of surfaces. Specifically, prior work has shown that the cellular response to a surface can be significantly enhanced by coating the implant surface with inorganic nano-particles and neuroadhesion protein L1, and this improvement occurs even when the surface chemistry is identical between the nanoparticle-coated and uncoated electrodes, suggesting the critical importance of surface topography. Here, we use transmission electron microscopy to characterize the topography of bare and nanoparticle-coated implants across 7 orders of magnitude in size, from the device scale to the atomic scale. The results reveal multiscale roughness, which cannot be adequately described using conventional roughness parameters. Indeed, the topography is nearly identical between the two samples at the smallest scales and also at the largest scales but vastly different in the intermediate scales, especially in the range of 5–100 nm. Using a multiscale topography analysis, we show that the coating causes a 76% increase in the available surface area for contact and an order-of-magnitude increase in local surface curvature at characteristic sizes corresponding to specific biological structures. These are correlated with a 75% increase in bound proteins on the surface and a 134% increase in neurite outgrowth. The present investigation presents a framework for analyzing the scale-dependent topography of medical device-relevant surfaces, and suggests the most critical size scales that determine the biological response to implanted materials.

Aims BoneMaster is a thin electrochemically applied hydroxyapatite (HA) coating for orthopaedic implants that is quickly resorbed during osseointegration. Early stabilization is a surrogacy marker of good survival of femoral stems. The hypothesis of this study was that a BoneMaster coating yields a fast early and lasting fixation of stems. Methods A total of 53 patients were randomized to be treated using Bi-Metric cementless femoral stems with either only a porous titanium plasma-sprayed coating (P group) or a porous titanium plasma-sprayed coating with an additional BoneMaster coating (PBM group). The patients were examined with radiostereometry until five years after surgery. Results At three months, the mean total translation (TT) was 0.95 mm (95% confidence interval (CI) 0.68 to 1.22) in the P group and 0.57 mm (95% CI 0.31 to 0.83) in the PBM group (p = 0.047). From two to five years, the TT increased by a mean of 0.14 mm (95% CI 0.03 to 0.25) more in the P group than in the PBM group (p = 0.021). In osteopenic patients (n = 20), the mean TT after three months was 1.61 mm (95% CI 1.03 to 2.20) in the P group and 0.73 mm (95% CI 0.25 to 1.21) in the PBM group (p = 0.023). After 60 months, the mean TT in osteopenic patients was 1.87 mm (95% CI 1.24 to 2.50) in the P group and 0.82 mm (95% CI 0.30 to 1.33) in the PBM group (p = 0.011). Conclusion There was less early and midterm migration of cementless stems with BoneMaster coating compared with those with only a porous titanium plasma-sprayed coating. Although a BoneMaster coating seems to be important for stem fixation, especially in osteopenic patients, further research is warranted . Cite this article: Bone Joint J 2022;104-B(6):647–656.

In an aging population with a rising incidence of peripheral artery disease, endovascular therapy is a favorable alternative to open surgical bypass. As a minimally invasive approach, endovascular therapy incurs less physiologic stress and periprocedural complications. Balloon angioplasty and stenting have been the predominant tools in peripheral endovascular therapy. The mechanisms of endovascular therapy have evolved beyond pneumatic dilation and forcing plaque against vessel wall with angioplasty and stenting. Technology has broadened to adjunctive local treatments with pharmaceutical agents coating balloons or eluting from stents, atherectomy to remove intimal and medial plaque, and more recently, intravascular lithotripsy to fracture and modify plaque. These technologies have performed well in curated clinical trials and in the real world for short-segment disease. Despite the excellent outcomes of treatment for short-segment occlusive disease, post-procedural patency of endovascular treatment for long-segment, highly calcified lesions remains challenging in the femoropopliteal region. The development of drug-coated balloons and stents brings the hope of improved patency. However, the results are incrementally better at best and are not superior to surgical bypass. In addition, there is controversy regarding the long-term mortality risk. With numerous devices and techniques as well as differing magnitudes of peripheral artery disease, it will be difficult to practically have a study to answer all questions regarding endovascular treatment of the femoropopliteal artery. This review examines current endovascular techniques for de novo and recurrent femoropopliteal arterial occlusive disease, as well as the applicability of intravascular ultrasound and optimal stenting strategies for long-segment disease.

Clinical applications of magnesium (Mg)-based screws have reported gas cavity formation in the surrounding tissue, which sometimes delays the fixation of the bone fracture. The gas cavity formation is considered to depend on the balance between hydrogen generation by Mg corrosion reacting with water in the body fluid and its diffusion into the surrounding tissue by capillary flow. In order to understand the gas cavity formation behavior by Mg-based material implantation, we developed a new in vitro model system to recreate this cavity formation phenomenon: the hydrogen generation by corrosion and its diffusion into the medium. A model tissue is prepared by gelation of the cell culture medium in a sterile condition. The immersion of Mg alloy samples was performed under 5% CO

Restenosis is a common complication after endovascular treatment of peripheral artery disease. Drug-coated balloon (DCB) treatment has been proven safe and effective in reducing the rate of restenosis for simple and short lesions. However, the clinical results of DCBs for long lesions are still very limited. This study aimed to evaluate the efficacy and safety of DCBs in the treatment of long femoropopliteal artery disease. And the results of this study will also complement the existing evidence of DCB treatment of long lesions.Patients with lesion length ≥ 15cm according to computed tomography angiography (CTA) or angiography in the AcoArt I Study were included into this study. Based on the balloon catheter used in treatment, patients were divided into the DCB group and the percutaneous transluminal angioplasty (PTA) group. The demographic, lesion, and procedural characteristics and 24-month follow-up results were compared between the 2 groups. The primary efficacy endpoints were angiographic late lumen loss (LLL) at 6 months or at the time of clinically driven target lesion revascularization (CD-TLR), primary patency (PP), freedom from CD-TLR, and changes in the ankle-brachial index (ABI) and Rutherford class during 24 months of follow-up. The safety endpoint was the occurrence of major adverse events.The total number of patients was 87, including 42 in the DCB group and 45 in the PTA group. There were no significant differences between the 2 groups in demographic, lesion,and procedural characteristics. The 6-month follow-up angiography showed that the LLL was significantly smaller in the DCB group than the PTA group (0.27 ± 0.90 mm vs 1.32 ± 0.91 mm; P0.001). At 24 months, compared with the PTA group, the DCB group had a significantly higher rate of freedom from CD-TLR (81.58% vs 43.18%; P0.001) and a significantly higher PP rate (46.88% vs 15.00%; P = 0.003). The DCB group had a significantly higher ABI than the PTA group at 6, 12, and 24 months (P0.001, P = 0.004 and P = 0.018, respectively). The DCB group had a better Rutherford class than the PTA group at 6 and 12 months (P = 0.033 and P = 0.012, respectively); the Rutherford class did not significantly differ between the 2 groups at 24 months (P = 0.127). The incidence of major adverse events did not significantly differ between the 2 groups.The effectiveness of the DCB is superior to a standard uncoated balloon in treating long lesions during 24 months of follow-up. Furthermore, the safety of the DCB is equivalent to that of PTA.

OBJECTIVES To compare drug-coated balloon (DCB) and bare metal stent (BMS) for primary lesions in femoropopliteal artery disease in Chinese population and to make subgroup analysis between the groups. METHODS Patients with primary lesions who underwent BMS or DCB treatment of a single tertiary vascular center were included and followed up for 24 months. Clinical and anatomic status were reported using the criteria recommended by the Society for Vascular Surgery. The primary endpoint included primary patency, clinically target limb revascularization, composite safety endpoint and all-cause death over 24 months assessed by Kaplan-Meier. Secondary endpoints included technical success rate and stent-related complications. RESULTS 284 patients with 324 limbs were pooled into analysis and most of the baseline characteristics did not show significant difference. 74 in BMS group and 71 in DCB group were claudicants while 83 in BMS group and 56 in DCB group suffered from chronic limb threatening ischemia (CLTI). The mean cumulative lesion length was 18.7±9.8cm in BMS group while 17.2±10.3cm in DCB group. Kaplan-Meier estimates of primary patency were 75.3% and 80.9% for BMS and DCB groups at 12 months while decreased to 63.9% and 70.2% at 24 months (log-rank p=0.167), respectively. Freedom from clinically driven target limb revascularization was 86.8% and 92.7% for BMS and DCB groups at 12 months while dropped to 82.5% and 85.9% at 24 months (log-rank p=0.342). Estimates of primary patency between BMS and DCB group did not show significant difference on lesions with poor runoff (58.8% versus 67.3%, log-rank p=0.127), severe calcification (64.5% versus 69.4%, log-rank p=0.525) and popliteal artery involvement (59.3% versus 60.3%, log-rank p=0.695) at 24 months. The overall survival (92.6% for BMS, 90.3% for DCB, log-rank p=0.391) and freedom from composite safety endpoint (79.3% for BMS, 79.2% for DCB, log-rank p=0.941) showed no significant difference at 24 months. CONCLUSIONS Over the 24-month follow-up, BMS and DCB showed equivalent efficacy and safety outcomes for primary femoropopliteal artery disease, which indicated the reduction of permanent metallic implant insertion might be possible.

Objective To compare the outcomes of heparin bonded expanded polytetrafluoroethylene (HePTFE) and autologous saphenous vein (ASV) in patients undergoing below-knee (BK) femoro-popliteal bypass for critical limb ischemia (CLI). Design Retrospective single-centre matched case–control study. Methods From 2003 to 2019, 275 consecutive BK bypasses for CLI were performed, 109 with the ASV and 166 with a HePTFE graft. All the baseline characteristics that were reliably measured and were potentially relevant in the decision-making process were included as confounders in a logistic regression model and the factors that were significantly different between the two groups then used to perform a propensity matching analysis. Propensity score-based matching was performed in a 1:1 ratio to compare outcomes. Arterial hypertension, hyperlipemia, the need for tibial anastomosis at the distal level and the run-off status were the covariates included in the matching. Follow-up outcomes were estimated by Kaplan–Meier methods and compared with log rank test. Results After propensity matching, 101 HePTFE bypasses were matched with 101 ASV bypasses. The median duration of follow-up was 37 months (range 1–192). The 5-year survival rate was 67.5% (standard error (SE) 0.05) in the HePTFe group and 64.5% (SE 0.06) in the ASV group (p = 0.8, log rank 0.04). Primary patency rates were 38% (SE 0.06) in the HePTFE group and 41% (SE 0.06) in the ASV group (p = 0.7, log rank 0.3). Also assisted primary patency and secondary patency rates did not differ in the two groups. Amputation-free survival was 53% (SE 0.05) in the HePTFE group and 58% (SE 0.06) in the ASF group (p = 0.6, log rank 0.2). Conclusions HePTFE provided 5-year similar results to those obtained with use of the ASV in equivalent patients with CLI undergoing below-knee or tibial bypass.

Endowing metal implants with multifunctional traits to prevent implant-associated infections and improve osseointegration has become a pivotal facet in orthopedics and dental fixation. Herein, we report the synthesis of mesoporous 70S bioactive glass-silk fibroin nanocomposites inspired by the biomimetic organo-apatites of mineralized collagen. The mesoporous, biomimetic nanocomposites enabled loading of antibiotics (gentamicin and doxycycline) and favored their release in a rapid manner while preserving their bioactivity. Ease in modification of the mesoporous nanocomposites enabled tailoring of 3-(aminopropyl)-triethoxysilane to the silanol network of bioactive glass, which improved the loading capacity of the hydrophobic drug (dexamethasone). The modification favored the slow and sustained release of dexamethasone from the modified mesoporous nanocomposites, which is desired for mediating osteogenesis and immunomodulation. Conformal coatings of these drug-loaded nanocomposites were materialized on stainless-steel implants through a facile electrophoretic deposition (EPD) technique, wherein the deposition yield can be controlled by applied parameters. Antibiotic coatings exhibited antibacterial efficacy with bioactivity retained up to 28 days, while dexamethasone-loaded coatings favored mesenchymal stem cell adhesion and osteoinduction. The immunomodulatory roles were also ascertained, wherein M2 macrophage biasness was favored in dexamethasone-loaded coatings. The versatility of these mesoporous biomimetic nanocomposites guarantee the loading of scenario-specific drugs to aid their local delivery through the conformal EPD coatings developed over metal implants toward improving implant patency.

Surface modification with cationic polymer coatings represented an important strategy to address the medical device-related infection issues. However, limited antibacterial activities and high cytotoxicity have hampered their development. Herein, we report a facile method to enhance the surface antibacterial activity by construction of an imidazolium-based polypeptide with fosfomycin counteranions (i.e., S

Major advances have been made in coronary artery stent technology over the last decades. Drug-eluting stents reduced in-stent restenosis and have shown better outcomes compared with bare metal stents, yet some limitations still exist to their use. Because they delay healing of the vessel wall, longer dual antiplatelet therapy is mandatory to mitigate against stent thrombosis and this limitation is most concerning in subjects at high risk for bleeding. The COBRA PzF nanocoated coronary stent has been associated with accelerated endothelialization relative to drug-eluting stents, reduced inflammation and thromboresistance in preclinical studies, suggesting more flexible dual antiplatelet therapy requirement with potential benefits especially in those at high bleeding risk. Here, we discuss the significance of COBRA PzF in light of recent experimental and clinical studies.Coronary artery disease occurs when the inner walls of the coronary arteries thicken due to plaque build-up. As the plaque develops, the inside of the artery narrows, and blood flow to the heart muscle is restricted. Coronary stents act as a miniature circular scaffolding that flexes to fit the shape of the artery. In the COBRA PzF nanocoated coronary stent, Polyzene F nanocoating (PzF) has been applied to the stent’s surface. Experimental studies have shown that PzF nanocoatings promote healing after stent implantation and reduce the attachment of platelets and inflammatory cells. The principal safety and effectiveness for the COBRA PzF stent has been proven by clinical studies, showing that the COBRA PzF stent was as safe and effective as other approved bare metal coronary stents. Here, we summarize the findings of experimental and clinical studies with the COBRA PzF stent and discuss potential future directions of anti-platelet and anti-coagulant medications following COBRA PzF stent implantation.

Objective In this systematic review and meta-analysis, we aimed to compare drug-coated balloon (DCB) to drug-eluting stent (DES) in patients with femoropopliteal lesions in terms of restenosis, target lesion revascularization (TLR), and mortality. Methods A comprehensive literature search was performed through PubMed, Scopus, and Embase databases. The intervention group was patients receiving percutaneous balloon angioplasty using the DCB. The control group was patients receiving percutaneous intervention using the DES. The primary outcome was restenosis, and the secondary outcomes were TLR and mortality. Results There were 4 studies comprising 812 patients (906 lesions) included in this systematic review and meta-analysis. The rate of restenosis was .19 [.13, .26] in DCB and .24 [.20, .28] in DES. There was a trend toward lower rate of restenosis (OR .73 [.52, 1.03], P = .074; I2: 46.3%) for DCB use compared to DES use. The rate of TLR was .11 [.08, .14] in DCB and .17 [.14, .21] in DES. TLR was lower (OR .61 [.41, .92], P = .017; I2: 1.2%) in the DCB group compared to the DES group. There were no significant differences in mortality (OR 1.38 [.78, 2.44], P = .268; I2: 0%) among the two groups. Meta-regression analysis showed that the rate of restenosis in DCB in this pooled analysis was affected by sex (reference: male, coefficient −.004, P = .009), smoking (coefficient: .003, P = .010), and total occlusion (coefficient: .008, P = .004). Conclusion DCB use in patients with femoropopliteal lesion was associated with similar rate of restenosis, lower TLR, and similar mortality rate compared to DES use.

Inside a spacecraft, the temperature and humidity, suitable for the human crew onboard, also creates an ideal breeding environment for the proliferation of bacteria and fungi; this can present a hazard to human health and create issues for the safe running of equipment. To address this issue, wear-resistant antimicrobial thin films prepared by magnetron sputtering were developed, with the aim to coat key internal components within spacecrafts. Silver and copper are among the most studied active bactericidal materials, thus this work investigated the antibacterial properties of amorphous carbon coatings, doped with either silver, silver and copper, or with silver clusters. The longevity of these antimicrobial coatings, which is heavily influenced by metal diffusion within the coating, was also investigated. With a conventional approach, amorphous carbon coatings were prepared by cosputtering, to generate coatings that contained a range of silver and copper concentrations. In addition, coatings containing silver clusters were prepared using a separate cluster source to better control the metal particle size distribution in the amorphous carbon matrix. The particle size distributions were characterized by grazing-incidence small-angle X-ray scattering (GISAXS). Antibacterial tests were performed under both terrestrial gravity and microgravity conditions, to simulate the condition in space. Results show that although silver-doped coatings possess extremely high levels of antimicrobial activity, silver cluster-doped coatings are equally effective, while being more long-lived, despite containing a lower absolute silver concentration.

To compare the efficacy and safety between paclitaxel coated balloon (PCB) angioplasty and conventional balloon (CB) angioplasty in the treatment of dysfunctional arteriovenous fistula (AVF).We searched four major electronic databases (PubMed, EMBASE, Web of Science and the Cochrane Library) for randomized controlled trials (RCTs) published from inception through November 28, 2021. Outcomes of interest included target lesion primary patency (TLPP), technical success and all-cause mortality. The STATA package version 15.1 was utilized to undertake meta-analyses.Fourteen RCTs totaling 1535 patients were analyzed. The available data showed that there were no significant differences of TLPP rates at 3, 6, 9 and 12 months between the PCB group and the CB group (risk ratio (RR) 1.00, 95% confidence interval (CI) 0.93-1.07,PCB angioplasty did not appear to convey any obvious advantage over CB angioplasty in the treatment of dysfunctional AVF. However, further multi-center, large-scale and well-designed RCTs are needed to prove outcomes.

Introduction: Femoropopliteal artery in-stent restenosis (ISR) remains a challenging treatment. We performed a network meta-analysis (NWM) for femoropopliteal artery ISR to explore the safety and efficacy of endovascular therapeutic strategies. Methods: The MEDLINE, Embase, Web of Science, and Cochrane databases were used as data sources. The network meta-analysis (NWM) approach used random-effects models based on the frequentist framework. We compared technical success rate, primary patency, target lesion revascularization (TLR), and major amputation at the 12-month follow-up for femoropopliteal artery ISR. Results: In total, 14 eligible studies (10 prospective and four retrospective; 1348 patients; and eight treatment modalities – standard balloon angioplasty (SBA), drug-coated balloon (DCB), peripheral cutting balloon angioplasty (PCBA), Viabahn endoprosthesis (VBE), directional atherectomy (DA), excimer laser atherectomy (ELA), and combinations – were included. The primary patency rates (at 6 months) were significantly higher for DCB and ELA+DCB than for SBA and ELA+SBA. ELA+DCB had higher primary patency rates (at 12 months) than ELA+SBA and SBA. The technical success rates were significantly lower for DCB and SBA than for VBE. The major amputation rates were significantly lower for ELA+DCB than for DCB. Based on the surface values under the cumulative ranking curve (SUCRA), ELA+DCB was considered the best treatment in terms of primary patency at 6 months (SUCRA = 91.1), primary patency at 12 months (SUCRA = 82.3), and TLR (SUCRA = 83.4). Conclusion: ELA+DCB showed positive encouraging results in primary patency (6, 12 months), TLR, and major amputation in femoropopliteal ISR. The efficacy and safety of ELA+DCB are worthy of further investigation. PROSPERO Registration No.: CRD42021246674

Corrosion resistant and biocompatible AZ31 magnesium alloy surfaces were successfully prepared by ultrasonic cold forging and subsequent micro-arc oxidation. The properties of these ultrasonic cold forging pretreated (UCFT)AZ31 magnesium alloy surfaces containing Sr–Ca–P micro-arc oxide coating (MAO/UCFT/AZ31) were studied. Results showed that surface grain refinement of AZ31 Mg alloy in the depth of 400 μm owing to the ultrasonic cold forging pretreatment was verified, and which provides more discharge channels for subsequent micro-arc oxidation. Comparing with the AZ31 magnesium alloy (AZ31) and ultrasonic cold forging technology treated AZ31 magnesium alloy samples (UCFT/AZ31), the corrosion resistance of MAO/UCFT/AZ31 significantly improved, which is also supported by the immersion experiments and electrochemical tests in simulated body fluid. Meanwhile, the MAO/UCFT/AZ31 samples also had excellent cytocompatibility as well as MAO/AZ31 samples. These results may beneficial to the developing of biodegradable medical materials in future.

Bacterial infection and aseptic loosening caused by bone resorption at the implant interface are major clinical complications during bone defect implantation surgery, and surface modification of the implant to address the aforementioned problems has long been a research focus.In this paper, a chitosan (CTS)-tannic acid (TA) colloid coating with a negative charge and excellent hydrophilicity was prepared on a Ti6Al4V (TC4) surface using a layer-by-layer assembly method. The physical properties, anti-osteoclast activity, and antimicrobial activity of the coatings were investigated.The findings showed that when the pH value was 5 and the ratio of CTS:TA was 0.8, the carrying rate of TA was the best. Furthermore, the CTS-TA coating had no cytotoxicity on the morphology and proliferation of BMSCs cells and effectively inhibited the differentiation of RAW264.7 cells into osteoclasts and the proliferation of Staphylococcus aureus and Escherichia coli. With the increase in the immersion time of TC4 in CTS-TA colloid solution, the inhibitory effects will also enhance.Therefore, the preparation of the CTS-TA coating provides a revolutionary technique for implant surface modification to avoid postoperative bacterial infection and aseptic loosening.

Implant-associated infections (IAI) remains a common and devastating complication in orthopedic surgery. To reduce the incidence of IAI, implants with intrinsic antibacterial activity have been proposed. The surface functionalization and structure optimization of metallic implants can be achieved by surface modification using the phosphate chemical conversion (PCC) technique. Zinc (Zn) has strong antibacterial behavior toward a broad-spectrum of bacteria. Herein, Zn was incorporated into strontium-calcium-phosphate (SrCaP) coatings on titanium (Ti) via PCC method, and the influence of its doping amount on the phase, microstructure, antibacterial activity, and biocompatibility of the composite coating was researched. The results indicated that traces of Zn doping produced grain refinement of SrCaP coating with no significant effect on its phase and surface properties, while a higher Zn content induced its phase and microstructure transformed into zinc-strontium-phosphate (SrZn

Guided bone regeneration (GBR) techniques use barrier membranes to augment the alveolar ridge for the site-specific growth of bone defects. However, current approaches using cast metal substructures exhibit poor adaptation to the surgical site and increased risk of infection. This study aimed to fabricate multi-functional coatings with 3D-printed porous titanium-niobium (Ti-Nb) alloy meshes to maintain space, prevent the ingrowth of fibroblasts and inhibit the colonization of bacteria for GBR.Ti-Nb alloy meshes were prepared by selective laser melting (SLM) and used as substrates for novel surface coatings. Porous chitosan (CS)/ gelatin (G)/ doxycycline (Dox) coatings were formed on the meshes using electrophoretic deposition (EPD) and freeze-drying. The process of EPD was characterized through Fourier transform infrared spectroscopy (FT-IR), zeta potential, and particle size analysis. The cytotoxicity of the coatings was evaluated through the culture of osteoblasts and immunostaining. The antibacterial activity of the coatings was tested using inhibition zone tests against Staphylococcus aureus (S. aureus) and scanning electron microscope (SEM). The inhibition of fibroblasts infiltration and nutrients transfer properties were analyzed using immunostaining and permeability tests.High yield strength (567.5 ± 3.5 MPa) and low elastic modulus (65.5 ± 0.2 GPa) were achieved in Ti-Nb alloy bulk samples. The data of zeta potential, FT-IR and SEM indicated that porous spongy coatings were chemically bonded following EPD. In vitro analysis of CSGDox1 (containing Dox at 1 mg·mLThis study verified that the EPD of CSGDox coatings on the 3D-printed Ti-Nb meshes can maintain space, provide antibiotic release whilst maintaining a barrier against soft-tissue growth, which is essential for the success of GBR treatment.

Drug eluting stent (DES) remain several problems, including stent thrombosis, stent fracture and neoatherosclerosis. Stent-less Percutaneous coronary intervention (PCI) using a drug coated balloon (DCB) is a stent-less strategy, and several trials have supported the efficacy of DCB. However, the optimal preparation before using DCB was uncertain. The aim of this study was to investigate the optimal preparation for plaque oppression/debulking before DCB dilatation for de novo coronary artery lesion.A total 936 patients were treated using DCB from 2014 to 2017 at our institution. Among them, we analyzed 247 patients who underwent PCI using DCB alone for de novo lesion. The primary end point of this study was target lesion failure (TLF).The area under the receiver operating characteristic (ROC) curve (AUC) was used to determine the optimal cutoff value of % plaque area to predict TLF. ROC curve analysis revealed plaque area ≥ 58.5% (AUC, 0.81) were associated with TLF. Eligible 188 patients were divided into 2 groups (plaque area ≥ 58.5% [n = 38] and58.5% [n = 150]) according to IVUS data before using DCB. TLF was significantly higher in plaque area ≥ 58.5% group than in58.5% group (P 0.01). Multivariable analysis selected plaque area ≥ 58.5% as an independent predictor of TLF (hazard ratio 7.59, P 0.01).Lesion preparation achieving plaque area 58.5% was important in stent-less PCI using DCB.

Coatings with bioactive properties play a key role in the success of orthopaedic implants. Recent studies focused on composite coatings incorporating biocompatible elements that can increase the nucleation of hydroxyapatite (HA), the mineral component of bone, and have promising bioactive and biodegradable properties. Here we report a method of fabricating composite collagen, chitosan and copper-doped phosphate glass (PG) coatings for biomedical applications using electrophoretic deposition (EPD). The use of collagen and chitosan (CTS) allows for the co-deposition of PG particles at standard ambient temperature and pressure (1 kPa, 25 °C), and the addition of collagen led to the steric stabilization of PG in solution. The coating composition was varied by altering the collagen/CTS concentrations in the solutions, as well as depositing PG with 0, 5 and 10 mol% CuO dopant. A monolayer of collagen/CTS containing PG was obtained on stainless steel cathodes, showing that deposition of PG in conjunction with a polymer is feasible. The mass of the monolayer varied depending on the polymer (collagen, CTS and collagen/CTS) and combination of polymer + PG (collagen-PG, CTS-PG and collagen/CTS-PG), while the presence of copper led to agglomerates during deposition at higher concentrations. The deposition yield was studied at different time points and showed a profile typical of constant voltage deposition. Increasing the concentration of collagen in the PG solution allows for a higher deposition yield, while pure collagen solutions resulted in hydrogen gas evolution at the cathode. The ability to deposit polymer-PG coatings that can mimic native bone tissue allows for the potential to fabricate orthopaedic implants with tailored biological properties with lower risk of rejection from the host and exhibit increased bioactivity.

This study describes the synthesis, surface analysis, and biological evaluation of bioactive titanium surfaces. The aim was to achieve an improved effect on osteoinduction in dental and orthopedic implants. For this purpose, a chemistry was developed, which allows to bind the bioactive cyclopeptide cRGDfK covalently to biomedically used titanium via polyethylene glycol linkers of different lengths. The chemical process is practicable, robust, and metal-free. The resulting chemically modified titanium plates show improved osteoinductive properties. The modification with cRGDfK targets the integrin α

To study the safety and efficacy of cutting balloon angioplasty (CBA) followed by paclitaxel drug-coated balloon (PCB) angioplasty for recurrent venous lesions in arteriovenous fistulas (AVFs).We conducted a prospective single-arm cohort study of CBA followed by PCB angioplasty for recurrent AVF stenoses between September 2017 and April 2019. In total, 44 participants were recruited. Target lesions were included if they had recurred within 12 months post-angioplasty, were = 0.5 cm upstream from the arteriovenous anastomosis, and did not involve the central veins. Up to two non-target lesions per circuit/participant with the same definition were allowed. Lesions were considered separate when there was an intervening 2-cm segment of normal vessel. Technical success was defined as complete lesion effacement on angioplasty. End-points of target and circuit patency were evaluated clinically at 3, 6, and 12 months post-procedure.Technical success was 96% (42/44): Two participants were excluded from analysis due to the need for high-pressure balloon angioplasty as the target lesions did not efface with CBA. The median follow-up duration was 337.5 days. Mean stenosis pre- and post-angioplasty was 69.0% (51.6-84.8) and 20.8% (0-44.8), respectively. The target lesion primary, primary assisted and circuit patency for the entire study population (n = 42) were 61.6 ± 7.8%, 92.7 ± 4.0%, and 54.7 ± 7.9%, respectively, at 12 months. For participants without non-target lesions (n = 22), the rates were 77.3 ± 8.9%, 90.9 ± 6.1%, and 60.7 ± 11.0%, respectively, at 12 months.CBA followed by PCB angioplasty appears safe and feasible for treatment of recurrent venous lesions in dysfunctional AVFs.

The relative merits of the drug-coated balloon (DCB) versus uncoated balloon (UCB) angioplasty in endovascular intervention for patients with symptomatic lower extremity peripheral arterial disease (PAD) remains controversial.Online databases were queried with various combinations of keywords to identify relevant articles. Net adverse events (NAEs) and its components were compared using a random effect model to calculate unadjusted odds ratios (ORs).A total of 26 studies comprising 26,845 patients (UCB: 17,770 and DCB: 9075) were included. On pooled analysis, DCB was associated with significantly lower odds of NAE (OR: 0.47, 95% confidence interval [CI]: 0.36-0.61), vessel restenosis (OR: 0.46, 95% CI: 0.37-0.57), major amputation (OR: 0.68, 95% CI: 0.47-99), need for repeat target lesion (OR: 0.38, 95% CI: 0.31-0.47) and target vessel revascularization (OR: 0.62, 95% CI: 0.47-0.81) compared with UCB. Similarly, the primary patency rate was significantly higher in patients undergoing DCB angioplasty (OR: 1.44, 95% CI: 1.19-1.75), while the odds for all-cause mortality (OR: 0.96, 95% CI: 0.85-1.09) were not significantly different between the two groups. A subgroup analysis based on follow-up duration (6 months vs. 1 vs. 2 years) followed the findings of the pooled analysis with few exceptions.The use of DCB in lower extremity PAD intervention is associated with higher primary patency, lower restenosis, lower amputation rate, and decreased need for repeat revascularization with similar all-cause mortality as compared to UCB.

Background: Paclitaxel-coated balloons have shown safety and efficacy in the short- to intermediate-term; however, long-term data remain limited. Objectives: To report late safety and efficacy outcomes for a low-dose paclitaxel drug-coated balloon (DCB) compared with percutaneous transluminal angioplasty (PTA) in femoropopliteal lesions from a large randomized controlled trial (RCT). Methods: ILLUMENATE Pivotal is a multicenter, single-blind RCT conducted across 43 US and EU centers to examine the safety and efficacy of the Stellarex DCB for the treatment of femoropopliteal disease. Assessments were recorded for all active patients at 36 and 48 months. Vital status of patients formally exited from the study was also collected. Results: Primary patency through 36 months for patients treated with DCB was significantly higher compared with PTA (p=0.016). The primary safety endpoint through 36 months was 77.4% and 72.4%, respectively (p=0.377). Kaplan-Meier analysis indicated that a higher proportion of DCB subjects were event-free compared with PTA at all study visits. The rate of major adverse event (MAE) through 48 months was 32.9% in the DCB group and 37.9% in the PTA group (p=0.428). No differences in the rate of mortality were evident through 48 months of follow-up with 15.6% in the DCB group and 15.2% in the PTA group (p=0.929). Conclusions: Stellarex DCB was associated with significantly higher patency compared with PTA through 3 years with no mortality difference detected through 4 years. The data from the ILLUMENATE Pivotal RCT support the long-term safety and efficacy of the low-dose Stellarex DCB.

Osteogenesis on the interface between the implant and host bone is a synergistic processing of multiple systems involved in immune response, angiogenesis, osteogenesis, etc. However, regulation of the osteoimmune microenvironment on the implant surface to accelerate the osteogenesis through manipulating the polarization of macrophage phenotype is still beginning to be explored. We here demonstrate that macrophage phenotype is able to be regulated by decoration of mineralized collagen (MC) coating on the titanium implant surface via triggering the integrin-related cascade pathway of macrophages. Furthermore, regulation of the macrophage polarization and construction of the osteoimmune microenvironment by MC coating would subsequently accelerate the osteogenic differentiation of the mesenchymal stem cells. This work therefore emphasizes the importance of the osteoimmune microenvironment on osteogenesis and provides a promising strategy to improve the osteointegration of implants.

The aim of this study was to coat titanium substrate with bioactive glass nanoparticles and characterize the deposited surface coat.Amorphous bioglass nanoparticles20 nm in diameter were prepared using a modified sol-gel technique followed by a ball-milling process. The prepared nanoparticles were used to coat airborne particle-abraded titanium disks. The in vitro bioactivity of the bioglass nanopowder was confirmed using simulated body fluid. Coated surfaces were characterized in terms of microstructure, composition, thickness, phase structure, surface roughness, wettability, and tissue behavior in a rabbit model.Bioglass nanoparticles showed apatite formation under a scanning electron microscope (SEM) after 5 days, confirming that bioactivity was enhanced with increasing degradation rate for up to 2 weeks. An optimized deposition technique and heat-treatment process produced a homogenous coating with a uniform thickness of 32 to 39 μm. Chemical analysis confirmed the presence of silicon and calcium on the coated disks. Amorphous coated surfaces exhibited porous nano/microroughness with microcracks and super-hydrophilicity. The interface of the coated disks with subcutaneous tissue revealed good tissue adhesion, high cellular activity, and rich vascularization, with multinucleated cells in the microenvironment surrounding the coat, as confirmed using histomorphometric analysis.The results of this study show that it is feasible to coat titanium surfaces with bioactive glass nanoparticles with super-hydrophilicity and high biologic activity. These particles may promote the regenerative environment around dental implants.

Durable chitosan-based coating material used as a barrier for slow-release fertilizers in the agricultural soil. This approach decreases the intense usage of fertilizer and works on their accessibility for the plants' necessities. In present paper, the proposed coating material was prepared on the basis of chitosan-kaolinite composite (CS-Gl-K). Fourier transform infrared spectroscopy analysis (FTIR), Scanning Electron Microscopy (SEM), thermogravimetric analysis (ATG), XRD, swelling degree and biodegradability studies were used to analyze the influence of the kaolinite clay incorporation in chitosan film properties. The characterization of the chitosan composites has been thoroughly studied. The NPK mineral fertilizer was coated according to the dip-immersing process of chitosan-kaolinite composites. Slow-release efficiency was evaluated by determining the rate of phosphorus release from the covered granules into water and soil. Moreover, phosphorus release from coated NPK/CS-Gl-K granules was generally delayed contrasted with NPK/uncoated. In addition, the biodegradation investigation of the composite material (CS-Gl-K) in soil was affirmed its durability. The proposed coating material has good slow-release properties, low cost and is environmentally friendly. The FTIR, ATG and XRD spectra revealed a good intercalation between the kaolinite-clay pores and chitosan chains.

In orthopedic surgery, metals are preferred to support or treat damaged bones due to their high mechanical strength. However, the necessity for a second surgery for implant removal after healing creates problems. Therefore, biodegradable metals, especially magnesium (Mg), gained importance, although their extreme susceptibility to galvanic corrosion limits their applications. The focus of this study was to control the corrosion of Mg and enhance its biocompatibility. For this purpose, surfaces of magnesium-calcium (MgCa1) alloys were modified with calcium phosphate (CaP) or CaP doped with zinc (Zn) or gallium (Ga) via MgCa1 microarc oxidation. The effects of surface modifications on physical, chemical, and mechanical properties and corrosion resistance of the alloys were studied using surface profilometry, goniometry, scanning electron microscopy (SEM), energy-dispersive X-ray spectroscopy (EDS), nanoindentation, and electrochemical impedance spectroscopy (EIS). The coating thickness was about 5-8 mu m, with grain sizes of 43.1 nm for CaP coating and 28.2 and 58.1 nm for Zn- and Ga-doped coatings, respectively. According to EIS measurements, the capacitive response (Y-c) decreased from 11.29 to 8.72 and 0.15 Omega(-1) cm(-2) s(n) upon doping with Zn and Ga, respectively. The E-corr value, which was -1933 mV for CaP-coated samples, was found significantly electropositive at -275 mV for Ga-doped ones. All samples were cytocompatible according to indirect tests. In vitro culture with Saos-2 cells led to changes in the surface compositions of the alloys. The numbers of cells attached to the Zn-doped (2.6 x 10(4) cells/cm(2)) and Ga-doped (6.3 x 10(4) cells/cm(2)) coatings were higher than that on the surface of the undoped coating (1.0 x 10(3) cells/cm(2)). Decreased corrosivity and enhanced cell affinity of the modified MgCa alloys (CaP coated and Zn and Ga doped, with Ga-doped ones having the greatest positive effect) make them novel and promising candidates as biodegradable metallic implant materials for the treatment of bone damages and other orthopedic applications.

Introduction: Sirolimus coated balloon (SCB) is a promising treatment option to prevent restenosis for peripheral arterial occlusive disease (PAOD). This is a pilot first-in-human study of MagicTouch percutaneous transluminal angioplasty (PTA) SCB for treatment of PAOD for both femoropopliteal and below the knee arteries (BTK). Material and Methods: Xtreme Touch-Neo [MagicTouch PTA] Sirolimus Coated Balloon (XTOSI) pilot study is a prospective, single-arm, open-label, single-center trial evaluating MagicTouch PTA SCB for symptomatic PAOD. Primary endpoint was defined as primary patency at 6 months (duplex ultrasound peak systolic velocity ratio ≤2.4). Secondary endpoints included clinically driven target lesion revascularization (CD-TLR), amputation free survival (AFS), all-cause mortality, and limb salvage success. Results: Fifty patients were recruited. The mean age was 67 (n=31 [62%] males). SCB was applied to femoropopliteal in 20 patients (40%) and BTK in 30 patients (60%). Majority of treatments (94%) were performed for limb salvage indications (Rutherford scores 5 or 6). This was a high risk cohort, in which 90% had diabetes, 36% had coronary artery disease, 20% had end stage renal failure, and American Society of Anaesthesiologists (ASA) score was 3 or more in 80%. Mean lesion length treated was 227±81 mm, of which 36% were total occlusions. Technical and device success were both 100%. At 30 days, mortality was 2% and major limb amputation was also 2%. Six-month primary patency was 80% (88.2% for femoropopliteal; 74% for BTK). At 12 months, freedom from CD-TLR was 89.7% (94.1% for femoropopliteal; 86.3% for BTK), AFS was 81.6% (90.0% for femoropopliteal; 75.9% for BTK), all-cause mortality was 14.3% (10.0% for femoropopliteal; 17.2% for BTK), and limb salvage success was 92.9% (94.4% for femoropopliteal; 91.7% for BTK). There was a statistically significant increase between baseline and 6-month toe pressures for both femoropopliteal (57.3±23.3 mm Hg vs 82.5±37.8 mm Hg; pConclusions: MagicTouch PTA SCB in the XTOSI study showed promising 6-month primary patency and encouraging 12-month freedom from CD-TLR, AFS, and limb salvage rates. No early safety concerns were raised. Randomized trials are needed to investigate the safety and efficacy of SCB for treatment of PAOD.

Since their introduction Drug Coated Balloons (DCBs) have slowly gained their spot into everyday cath-lab practice, first for treatment of in-stent restenosis (ISR), more recently for small vessels disease; today a growing body of evidence start supporting their use in more complex lesions, from bifurcations, to large vessels, to acute lesions. Although the new generation of DCBs showed a better performance and safety than the older one, the drug of choice has always been the Paclitaxel; last year some concerns were raised on the safety of Paclitaxel devices, in particular the balloons mining their use. Recently Sirolimus ventured in the DCBs world, making its appearance on cath-lab shelves and becoming a good alternative to Paclitaxel (DCB).