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Boron doped (5 %, 10%, and 15 wt.%) Hydroxyapatite (B-HA) biocomposites were syntesized and coated on 316L SS and NiTi (Ni-45Ti) metallic substrates by using the electrophoretic deposition process (EPD). The morphological and structural characterization of the coatings was executed using scanning electron microscopy (SEM) and X-ray diffraction devices (XRD). Antibacterial tests were conducted using Escherichia coli ( E. coli, JM103) and Staphylococcus aureus ( S. aureus, ATCC29293) microorganisms. The mitochondrial activity assay (MTT)-[3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide] was used to examine cell viability and cytotoxicity in Saos-2 osteoblast cells. HA and boron peaks, as well as B-TCP and metallic components, were detected in XRD examinations. Porous morphologies were generated on the surface with boron doped B-HA coatings, as revealed by SEM views. Antibacterial activity studies revealed that both metallic coating groups, notably with boron doping, demonstrated antibacterial activity against gram-negative E. coli and gram-positive S. aureus. The antibacterial activity of the 316L group was shown to be better than that of the NiTi group in comparisonal testing. The syntesized boron-doped biocomposite coatings did not have any detrimental effects on living cells, according to cell viability studies. The cell viability rate was found to be greater in NiTi coatings than in 316 SS coatings, and the impact was amplified by the addition of boron.

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.

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.

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.

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.

Purpose: Percutaneous transluminal angioplasty (PTA) with conventional plain old balloon (POBA) and/or drug-coated balloon (DCB) is the primary intervention to treat peripheral artery stenoses. However, acute dissections during the procedure and potential for future target lesion revascularization remain procedural complications. The purpose of this study was to assess the acute and 12-month outcomes in patients who underwent novel vessel preparation with longitudinal, controlled-depth micro-incisions prior to PTA. Materials and Methods: Patients with symptomatic lower extremity peripheral arterial disease with a Rutherford class of 2 to 6 and >70% de novo stenosis of the superficial femoral or popliteal arteries were included in this retrospective study. Patients with thrombotic or embolic lesions, restenosis, or in-stent restenosis were excluded. The FLEX Vessel Prep System (FLEX VP) was used to prepare the vessel prior to PTA by creating micro-incisions at the target lesion. The FLEX VP was followed by POBA or paclitaxel DCB. Results: The study included 65 patients. Lesion characteristics were 90% median stenosis (range = 70%–100%), 75.4% mild-to-severe calcifications, and 33.8% occlusion rate, and median lesion length was 196 (range = 10–480) mm. Following vessel preparation, 82.1% of the patients had low severity dissection or no flow-limiting dissection. The provisional stent rate postprocedure was 16.9%, with a median stent length of 60 mm. The freedom from target lesion revascularization (FFTLR) in 63 evaluable patients at 6 and 12 months was 98.4% and 93.7%, respectively. Freedom from amputation was 100%. Conclusion: In this real-world/all-comers patient population with long, stenotic lesions across the calcification spectrum, vessel preparation with longitudinal micro-incisions prior to PTA was associated with low dissection rate, low dissection severity, low stent implantation, and high FFTLR with the absence of amputation at 12 months relative to published reports in long-lesion cohorts. These results support vessel preparation via micro-incisions.

Titanium implants present 2 major drawbacks—namely, the long time needed for osseointegration and the lack of inherent antimicrobial properties. Surface modifications and coatings to improve biomaterials can lose their integrity and biological potential when exposed to stressful microenvironments. Graphene nanocoating (GN) can be deposited onto actual-size dental and orthopedic implants. It has antiadhesive properties and can enhance bone formation in vivo. However, its ability to maintain structural integrity and quality when challenged by biologically relevant stresses remains largely unknown. GN was produced by chemical vapor deposition and transferred to titanium via a polymer-assisted transfer technique. GN has high inertness and did not increase expression of inflammatory markers by macrophages, even in the presence of lipopolysaccharides. It kept high coverage at the top tercile of tapered dental implant collars after installation and removal from bone substitute and pig maxilla. It also resisted microbiologically influenced corrosion, and it maintained very high coverage area and quality after prolonged exposure to biofilms and their removal by different techniques. Our findings show that GN is unresponsive to harsh and inflammatory environments and that it maintains a promising level of structural integrity on the top tercile of dental implant collars, which is the area highly affected by biofilms during the onset of implant diseases. Our findings open the avenues for the clinical studies required for the use of GN in the development of implants that have higher osteogenic potential and are less prone to implant diseases.

Objectives In this study, perioperative properties and early outcomes of patients who underwent combined Temren rotational atherectomy (RA) and drug-coated balloon (DCB) angioplasty treatment for complex femoropopliteal lesions in a single center were reported. Methods Between June 2019 and February 2020, 40 patients who underwent combined Temren RA and DCB treatment due to critical lower limb ischemia or claudication-limiting daily living activities were retrospectively evaluated. Results The mean age of patients was 73.2 ± 7.8 years and the majority of the patients were male (65%). Of the patients, 17 had critical limb ischemia and 23 had lifestyle-limiting claudication. Pathologies were total occlusion in 33 limbs and critical stenosis in seven limbs. Nine patients previously underwent endovascular intervention or surgery. The mean total occlusion length was 140.9 ± 100.9 (range, 20–360) mm in patients with chronic total occlusion. There was an additional iliac artery pathology in 5 and below the knee pathology in 8 patients. Rotational atherectomy was possible in all cases. Flow-limiting dissection was seen in six patients (15%). Provisional stent was performed to these patients. Following Temren RA, all patients underwent DCB. Adequate vascular lumen (less than 30% stenosis) was provided in all patients and the symptoms regressed. No distal embolization was encountered. Access site complications (17.5%) were small hematoma in four patients, ecchymosis in two patients, and pseudoaneurysm of the femoral artery in one patient. The mean follow-up was 13.55 ± 4.2 (range, 1–18) months. Re-occlusion was seen in three patients (7.5%) ( n = 2 at 2 months and n = 1 at 4 months). Of these patients, two had required open revascularization via femoropopliteal bypass graft with common, superficial femoral, and popliteal artery endarterectomy and one had required femoro-posterior tibial artery bypass. Four minor toe amputations (10%) were performed to reach complete wound healing in the critical limb ischemia patients. A below-knee amputation was performed in a 94-year-old patient with long segment stenosis at the end of a 1-month follow-up period. There was no mortality after follow-ups. The Kaplan–Meier estimator estimated the rate of freedom from target lesion revascularization (TLR) which was 92.3%. The decrease in the Rutherford levels after the procedure was found to be statistically significant in 36 patients ( p < 0.001). The increase in the ankle–brachial index after the procedure was found to be statistically significant in 36 patients ( p < 0.001). Conclusions Combined use of Temren RA with adjunctive DCB is safe and effective method with high rates of primary patency and freedom from TLR and low rates of complication in the treatment of femoropopliteal lesions.

Purpose: Clinical trials have demonstrated sustained benefits of drug-coated balloon (DCB) angioplasty compared with noncoated balloon angioplasty in symptomatic peripheral artery disease (PAD) presenting with femoropopliteal (FP) artery disease. However, there is still controversy whether particulate embolization caused by crystalline paclitaxel, the so-called “downstream effect,” is adversely associated with clinical outcomes after use of FP DCB among chronic limb-threatening ischemia (CLTI) patients. The current RADISH (Roles of Angioplasty with Drug-coated balloon for chronic ISchemia in wound Healing) study investigated wound healing following DCB therapy vs non-DCB therapy for real-world CLTI patients presenting with FP lesions. Materials and Methods: This multicenter, retrospective study analyzed 927 patients with CLTI (mean age, 76±10 years; male, 57.8%; diabetes mellitus, 64.5%; dialysis, 50.7%) presenting with FP lesions and treated endovascularly via DCB (138 patients) vs non-DCB therapy (789 patients) between April 2014 and March 2019. The primary outcome measure was 1-year wound healing, while the secondary outcome measure was 1-year primary patency. Clinically-driven target lesion revascularization (CD-TLR), limb salvage and overall survival were also analyzed by using propensity score matching analysis. Results: The propensity score matching extracted 111 pairs (as many patients in the DCB group and 629 patients in the non-DCB group). The 1-year cumulative incidence of wound healing (95% CI) was 74.4% (62.6% to 82.5%) in the DCB group and 71.9% (60.4% to 80.1%) in the non-DCB group, with no significant intergroup difference (p=0.93). The DCB group had a higher rate of primary patency (p=0.002) and freedom from CD-TLR (p=0.010) than the non-DCB group, whereas there was no significant intergroup difference in limb salvage (p=0.21) or overall survival (p=0.93). Conclusion: The current analysis of data from the RADISH study demonstrated that DCB therapy did not lead to delayed wound healing and reduced restenosis rate in CLTI patients presenting FP lesions. From this results, DCB therapy would be a reasonable treatment option for CLTI patients.

Purpose To assess the efficacy and safety of the Orchid drug-coated balloon (coated with paclitaxel) for the treatment of femoropopliteal artery disease versus percutaneous transluminal angioplasty in Chinese population. Methods This is a prospective, single center, single-blinded, randomized controlled trial that randomized (1:1) 60 patients (38 men; mean age 68.7 ± 8.8) to drug-coated balloon group ( n = 30) or percutaneous transluminal angioplasty group ( n = 30). The primary efficacy endpoint was primary patency of the target lesion and clinically driven target lesion revascularization (CD-TLR) at 12 months. The primary safety end point was freedom from perioperative death at 30 days and freedom from limb-related death and major amputation at 12 months. Results Baseline characteristics were similar between the two groups. Drug-coated balloon group resulted in higher primary patency (82.8% vs. 48.3%, p = 0.005) and lower CD-TLR rates (3.5% vs. 27.6%; p = 0.001) versus percutaneous transluminal angioplasty group at 12 months. The ABI was significantly higher in drug-coated balloon group than percutaneous transluminal angioplasty group (0.86 ± 0.13 vs. 0.72 ± 0.18, p = 0.025). There were no perioperative death at 30 days, no limb-related death and no major amputation at 12 months in either group. Conclusions The randomized controlled trial showed superior treatment effect with drug-coated balloon versus percutaneous transluminal angioplasty, with remarkably higher patency and lower CD-TLR rates. The result is consistent with other study and demonstrates the safety and efficacy of the Orchid drug-coated balloon for the treatment of femoropopliteal artery disease.

We evaluated the safety and efficacy of a resveratrol-paclitaxel-coated peripheral balloon catheter in an all-comer patient cohort undergoing endovascular treatment of above-the-knee and below-the-knee peripheral artery disease. CONSEQUENT ALL COMERS (Clinical Post-Market Clinical Follow-up [PMCF] on Peripheral Arteries treated with SeQuent Please OTW [Over-the Wire]) is a prospective, single-arm, multicenter observational study (ClinicalTrials Identifier: NCT02460042). The primary end point was the 12-month target lesion revascularization (TLR) rate. Secondary end points included vessel patency, target vessel revascularization, and all-cause mortality. A total of 879 lesions in 784 consecutive patients (71.3 ± 10.4 years old, 57.7% male) were analyzed; 53.3% had claudication, whereas the remaining 46.7% exhibited critical limb ischemia (CLI). Substantial comorbidities were present, including diabetes mellitus (41.2%), smoking (66.1%), and coronary artery disease (33.9%). Lesion length (879 lesions) was 12.0 ± 9.3 cm and 31.8% were Transatlantic Inter-Society Consensus II C/D lesions. The overall technical success rate of the 1269 drug-coated balloon (DCB)’s used was 99.6% (1.60 ± 0.79 DCB’s/patient). At 12 months, the TLR rates were 6.3% in patients with CLI and 9.6% in claudicants, with a primary patency rate of 89.9% and 87.1%, respectively. All-cause mortality was 4.3% (28/658). The most important predictors for TLR were female gender, in-stent restenosis at baseline and lesion length.

Both commercial and experimental antibacterial urinary catheters were investigated for their efficacy in preventing planktonic growth and biofilm formation of Escherichia Coli bacteria in a synthetic urine solution. Experimental antibacterial catheters having thin (2O, or Zn/Ag2O in polydimethylsiloxane (PDMS) binder all exhibited significant antimicrobial activity, outperforming traditional commercial antibacterial catheters. All experimental catheters prevented planktonic growth of bacteria and did not exhibit biofilm formation during a six-day test period using a colony forming unit (CFU) measurement method. On the other hand, the best performing commercial catheters demonstrated efficacy for only 3 days in planktonic growth tests and formed multiple bacterial colonies in CFU measurements. The Zn/Ag2O/PDMS experimental catheter was the only catheter observed to produce hydrogen peroxide, a reactive oxygen species known to inhibit biofilm formation; lack of detectable hydrogen peroxide production by the Ag2O/PDMS and Ag/Ag2O/PDMS experimental catheters suggests that bactericidal action most likely arises from release of silver ions present in the PDMS coatings.

Purpose To examine nationwide variations in inpatient use of drug-coated balloons (DCBs) for treating femoropopliteal segment occlusive disease and whether DCBs are associated with reduced early out-of-hospital health care utilization. Materials and Methods The study included 24,022 patients who survived hospitalization for femoropopliteal revascularization using DCB angioplasty (n=7850) or uncoated balloon angioplasty (n=16,172) in the 2016–2017 Nationwide Readmissions Database. Differences in patient, hospitalization, and institutional characteristics were compared between treatment strategies. Adjusted logistic regression models were used to examine differences in 6-month rates of readmission, amputation, and repeat intervention. Results are presented as the odds ratio (OR) and 95% confidence interval (CI). Results Patients treated with DCBs had a higher prevalence of chronic limb-threatening ischemia, diabetes, hypertension, and tobacco use. Revascularization with a DCB was associated with shorter hospitalizations, lower median hospitalization costs, and fewer inpatient lower extremity amputations. Readmissions at 6 months were decreased in patients treated with DCBs compared with uncoated balloon angioplasty (OR 0.90, 95% CI 0.83 to 0.98, p=0.014). The most common reasons for readmission were complications related to procedures (15.4%) and diabetes (15.4%). Compared to patients treated with DCBs, patients treated with uncoated balloon angioplasty were more often readmitted with early procedure-related complications (13.3% vs 17.5%). There were no between-group differences in readmission for sepsis, myocardial infarction, or congestive heart failure. Conclusion DCBs are less often used compared to uncoated balloons during inpatient femoropopliteal procedures. While DCB utilization is associated with more severe comorbidities and advanced peripheral artery disease, readmission rates are decreased through the first 6 months.

Background and objectives: The blood compatibility of indwelling intravascular catheters is facilitated by the use of antithrombogenic materials. Heparin has typically been used for this purpose; however, since heparin-coated catheters are considered combination products, difficulties meeting the relevant Food and Drug Administration safety recommendations have disrupted commercialization. Other issues include coating durability and the occurrence of heparin-induced thrombocytopenia. Polymer coatings are a potential alternative; however, polymer antithrombogenicity in circulating human blood has yet to be demonstrated. The present study aimed to establish the ex vivo antithrombogenicity of a poly-2-methoxyethylacrylate (PMEA) polymer coating applied to a central venous catheter using an artificial human blood circulation system. Methods: The present study used an artificial human blood circulation system to conduct an ex vivo evaluation of the antithrombogenicity of poly-2-methoxyethylacrylate (PMEA)-coated catheters. Human blood samples obtained from volunteer donors were loaded into a circulation system fitted with either a PMEA-coated or uncoated catheter. After 3-h, the catheter was removed and examined using scanning electron microscopy. Protein adsorption on the catheter surface was investigated by shredding the catheter that had contacted the blood inside the circulation system and immersing the pieces in 1 mL of 0.5 N NaOH for 2 days. The amount of protein in the 0.5 N NaOH was determined according to the Lowry method. Results: Adherent fibrin, which forms a sheath on the catheter surface, was observed on uncoated, but not PMEA-coated catheters. Furthermore, the amount of protein adsorption was significantly less with PMEA-coated than uncoated catheters ( p = 0.043). Conclusions: The present findings demonstrated the antithrombogenicity of PMEA-coated catheters in circulating human blood.

ObjectivesThe purpose of this study was to evaluate the results of combining superficial femoral artery endovascular therapy with distal bypass originating from the popliteal artery as a method of lower extremity revascularization in patients with chronic limb-threatening ischemia.MethodsThe records of patients undergoing combined superficial femoral artery endovascular therapy with popliteal-to-distal bypass for chronic limb-threatening ischemia from January 2014 to April 2020 at a single institution were retrospectively reviewed. The patients’ background, operative details, and long-term outcomes were analyzed.ResultsFifty-two popliteal-to-distal bypasses with superficial femoral artery endovascular therapy were performed in 49 patients (33 men; mean age, 76 ± 9 years; diabetes mellitus, 80%; end-stage renal disease with hemodialysis, 47%). The Trans-Atlantic Inter-Society Consensus II classification of superficial femoral artery–popliteal lesion was “A” in 8 (15%) patients, “B” in 14 (27%) patients, “C” in 24 (46%) patients, and “D” in 6 (12%) patients. The intervention for superficial femoral artery lesions was plain old balloon angioplasty in 4 patients, self-expandable nitinol stent in 15 patients, drug-coated balloon in 18 patients, drug-eluting stent in 4 patients, stent graft in 10 patients, and interwoven nitinol stent in 1 patient. Distal bypass originated from the above-knee popliteal artery in 9 (17%) limbs and the below-knee popliteal artery in 43 (83%) limbs. The most common outflow artery was the posterior tibial artery (44%). The mean follow-up period was 17 ± 17 months. The primary and secondary patency of the graft was 44% and 72%, respectively, at 1 year and 39% and 72%, respectively, at 3 years. Primary patency and freedom from clinical-driven target lesion revascularization of superficial femoral artery endovascular therapy lesions were 85% and 90%, respectively, at 1 year and 63% and 75%, respectively, at 3 years. Limb salvage was 97% at 1 year and 92% at 3 years. Wound healing was 67% at 6 months and 83% at 12 months.ConclusionsCombined superficial femoral artery endovascular therapy with popliteal-to-distal bypass may be a promising approach for patients with chronic limb-threatening ischemia because of durable patency, acceptable wound healing, and good limb salvage.

Bacterial infections and lack of osseointegration may negatively affect the success of titanium (Ti) implants. In the present study, a functional coating composed of chitosan (CS) microspheres and nano hydroxyapatite (nHA) was prepared to obtain antimicrobial Ti implants with enhanced bioactivity. First, the chitosan microspheres were fixed to Ti surfaces activated by alkali and heat treatment, then nHA coatings were precipitated onto these surfaces. Ciprofloxacin was loaded into the microspheres using two different procedures; encapsulation and diffusion. Scanning electron microscopy micrographs of the modified Ti surfaces showed that the coating was successfully deposited onto the Ti surfaces and stable for 30 days in PBS. The drug was completely released from free microspheres loaded by encapsulation in 21 days whereas only 89% release was observed after immobilization. The burst release also decreased from ca. 55% to ca. 35%. The release was further reduced following the nHA precipitation. The modified Ti surfaces showed antimicrobial activity based on the bacterial time-kill assay using S. aureus, but the efficiency was affected by both nHA precipitation and drug loading strategy. Highest antimicrobial activity was seen in the samples without nHA layer, and when the drug was loaded by diffusion. Fourier transform infrared spectroscopy and X-ray diffraction analyses revealed that nHA on the surface enhanced HA growth in simulated body fluid for 3 weeks, showing increased osseointegration potential. Therefore, the proposed coating may be used to prevent Ti implant failure originated from bacterial infection and/or low bioactivity.

Purpose To compare the safety and efficacy of drug-coated balloon (DCB) vs uncoated balloon angioplasty in the treatment of de novo and restenotic infrapopliteal lesions in patients with chronic limb-threatening ischemia (CLTI). Materials and Methods The prospective, multicenter, randomized study AcoArt II–BTK study ( ClinicalTrials.gov identifier NCT02137577) enrolled 120 patients who were randomly assigned to angioplasty with either a DCB (n=61; mean age 70.7±7.4 years; 36 men) or a conventional balloon catheter (n=59; mean age 70.8±9.0 years; 36 men). There were no significant differences observed in baseline clinical or target lesion characteristics between the groups. The target lesion length was 169.95±86.35 mm in the DCB group vs 179.93±80.16 mm in the control group, and approximately three-quarters of the lesions were chronic occlusions. Primary patency was assessed by angiography at 6 months, and mortality and clinically-driven target lesion revascularization (CD-TLR) were evaluated at 12 months. Results Primary patency at 6 months was 75.0% in the DCB group and 28.3% in the control group (pConclusion This study demonstrated that the Litos/Tulip DCBs are safe and effective in treating infrapopliteal lesions, with improved angiographic and clinical outcomes vs plain balloon angioplasty. The DCBs demonstrated significantly higher primary patency with fewer CD-TLRs than conventional angioplasty. The safety of the DCBs was noninferior to that of the uncoated balloons after 1 year of follow-up.

Background: Infections remains the most feared complication in total hip arthroplasty (THA). New strategies of PJI prevention includes coating of conventional implants. Defensive Antibacterial Coating (DAC), an antibacterial hydrogel coating made of hyaluronan, poly-D and L-lactide can protect biomaterials as an effective barrier at the time of implantation. In addition, it can be used with topical antibiotics to prevent early colonisation of the implant. Scope: This manuscript describes the detailed function of the DAC in general as well as an analysis of its use in revision THA in a series of 28 patients in a short-term follow-up. Its use in patients undergoing cementless re-implantation after 2-staged procedures in THA is described in detail within the manuscript. Conclusion: DAC found to be effective in terms of infection control and safety in our patient cohort and has been expanded for cementless 1-staged revisions in PJI of the hip in our institution.

Keratin-based biomaterials represent an attractive opportunity in the fields of wound healing and tissue regeneration, not only for their chemical and physical properties, but also for their ability to act as a delivery system for a variety of payloads. Importantly, keratins are the only natural biomaterial that is not targeted by specific tissue turnover-related enzymes, giving it potential stability advantages and greater control over degradation after implantation. However, in-situ polymerization chemistry in some keratin systems are not compatible with cells, and incorporation within constructs such as hydrogels may lead to hypoxia and cell death. To address these challenges, we envisioned a pre-formed keratin microparticle on which cells could be seeded, while other payloads (e.g. drugs, growth factors or other biologic compounds) could be contained within, although studies investigating the potential partitioning between phases during emulsion polymerization would need to be conducted. This study employs well-established water-in-oil emulsion procedures as well as a suspension culture method to load keratin-based microparticles with bone marrow-derived mesenchymal stem cells. Fabricated microparticles were characterized for size, porosity and surface structure and further analyzed to investigate their ability to form gels upon hydration. The suspension culture technique was validated based on the ability for loaded cells to maintain their viability and express actin and vinculin proteins, which are key indicators of cell attachment and growth. Maintenance of expression of markers associated with cell plasticity was also investigated. As a comparative model, a collagen-coated microparticle (Sigma) of similar size was used. Results showed that an oxidized form of keratin (“keratose” or “KOS”) formed unique microparticle structures of various size that appeared to contain a fibrous sub-structure. Cell adhesion and viability was greater on keratin microparticles compared to collagen-coated microparticles, while marker expression was retained on both.

Objective To compare drug (paclitaxel)-coated balloon angioplasty with femoropopliteal bypass surgery in the treatment of femoropopliteal lesions. Methods A retrospective study was performed between January 2015 and January 2019, covering a four-year period. All subjects who underwent femoropopliteal bypass surgery and drug-coated balloon angioplasty over a four-year period were evaluated. The subjects’ demographic characteristics, lesion characteristics, treatment outcomes and disease-free survival were collected. Subjects were divided into the femoropopliteal bypass group (Group A) and the drug-coated balloon angioplasty (Group B) group. Results In total, 220 subjects were enrolled. Both Group A and Group B consisted of 110 subjects. The proportion of patients with a claudication distance between 0 and 50 m was significantly higher in Group A, and the proportion of patients with a claudication distance between 50 and 100 m was significantly higher in Group B ( p = 0.001). In terms of the Rutherford levels, moderate claudication was significantly higher in Group B, and severe claudication was significantly higher in Group A ( p = 0.001). The lesion length for the subjects in Group A was significantly longer than that in Group B (24.61 ± 2.79 mm for Group A and 18.59 ± 3.95 mm for Group B, p = 0.001). The stenosis degree in Group A was also significantly higher than that in Group B (96.82 ± 4.32% for Group A and 94.85 ± 4.55% for Group B, p = 0.001). The duration of the procedure, duration of hospitalization and rate of bleeding in Group A were significantly higher than those in Group B. The incidence of overall morbidity and reintervention rates in Group B were significantly higher than that in Group A. The preoperative ankle brachial index values of the subjects in Group B were statistically significantly higher than those in Group A (0.56 ± 0.08 for Group A and 0.61 ± 0.08 for Group B, p = 0.001). The change in the ankle brachial index measurement of the subjects in Group A with respect to the preprocedure value was significantly greater than that in Group B ( p = 0.001). For primary patency, there was a significant difference between the groups in the distribution of the duplex ultrasound results at the 3rd, 6th, 9th and 12th month control points ( p = 0.001). At all control points, Group A had better primary patency rates, whereas the secondary patency rates did not differ. In total, among the 220 patients, 125 (56.8%) were disease free, and 95 (43.2%) experienced recurrence. The mean disease-free survival times for Group A and Group B were 10.45 ± 0.28 months and 9.11 ± 0.37 months, respectively. The disease-free survival rates were significantly higher in Group A ( p = 0.001, p Conclusion Femoropopliteal bypass resulted in better disease-free survival rates than drug-coated balloon angioplasty and serves as an effective modality for the treatment of femoropopliteal lesions.

We report 8-year experience with vascular access complications (VACs) after percutaneous transfemoral transcatheter aortic valve implantation (TAVI). From January 2010 to January 2018, patients with iliofemoral VAC treated by an intervention following percutaneous transfemoral TAVI were included. Major VAC was defined according to the Valve Academic Research Consortium 2 classification. As first-line strategy, VACs were treated using covered nitinol stents (CS). Among 795 percutaneous transfemoral TAVI, 74 (9.3%) patients (female, 57%; 82 ± 8 years) with VAC treated by CS and/or open repair were included in this study: 59 CS cases and 15 open repair cases. Two CS patients were converted to open repair. Technical success for stent implantation was 97%. The main VAC was a persistent bleeding related to percutaneous closure device failure (72%). Thirty-day mortality in the study cohort was 5.4% (4/74), including 1 VAC-related death. One patient had postoperative lower limb ischemia successfully treated by open repair. No amputation, new-onset claudication or in-stent occlusion was recorded. Endovascular intervention using self-expandable nitinol covered stent is safe and effective as a first-line strategy for the treatment of VAC in percutaneous transfemoral TAVI. However, open repair is needed in case of unfeasibility or failure of endovascular therapy.

Purpose:To evaluate the 3-year safety and effectiveness of the MDT-2113 (IN.PACT Admiral) drug-coated balloon (DCB) vs percutaneous transluminal angioplasty (PTA) in a Japanese population with femoropopliteal occlusive disease.Materials and Methods:The multicenter, prospective, IN.PACT SFA Japan randomized controlled trial ( ClinicalTrials.gov identifier NCT01947478) was an independently adjudicated study evaluating Japanese participants randomized 2:1 to DCB (n=68) or PTA (n=32). The effectiveness endpoint was primary patency through 36 months, defined as freedom from clinically-driven target lesion revascularization (CD-TLR) and freedom from restenosis (by duplex ultrasound). The effectiveness endpoint was evaluated using the Kaplan-Meier method; estimates are presented with the 95% confidence intervals (CIs). The safety composite endpoint was freedom from device- and procedure-related death through 30 days and freedom from major target limb amputation and clinically-driven target vessel revascularization through 36 months.Results:Primary patency by Kaplan-Meier estimate was higher in the DCB group (68.9%, 95% CI 57.5% to 80.2%) vs the PTA group (46.9%, 95% CI 29.6% to 64.2%) at 36 months (log-rank p=0.001). The CD-TLR rates were 14.9% (10/67) for the DCB group and 20.7% (6/29) for PTA (p=0.554). The safety composite endpoint occurred in 83.6% (56/67) of DCB participants and 75.9% (22/29) of PTA participants (p=0.402). All-cause death was similar between groups at 36 months [DCB 6.0% (4/67) vs PTA 6.9% (2/29), p>0.999), with no device- or procedure-related deaths in either group.Conclusion:The final report of the IN.PACT SFA Japan trial showed that the IN.PACT Admiral DCB is safe and had durable outcomes through 3 years in Japanese participants with femoropopliteal occlusive disease.

Background:Deep infection after open reduction internal fixation (ORIF) of ankle fractures represents a challenge to the orthopaedic surgeon, particularly in patients in whom conventional surgical treatments have failed. The aim of this study was to assess the results of a modified technique of tibiotalocalcaneal fusion using a retrograde locked intramedullary nail covered in cement with antibiotics.Methods:Six patients treated using the authors’ technique were analyzed retrospectively. All patients had deep infection after ankle osteosynthesis and several surgical procedures (debridement, external fixation, etc) had failed. Radiographs were analyzed to confirm the healing of the bone. Outcome was measured by maintained construct stability and eradication of infection (no clinical signs of infection and normal values of laboratory markers). The average age of the series was 64.2 (range, 50-75) years, and the average follow-up period was 19.5 (range, 8-41) months.Results:Tibiotalocalcaneal stability and eradication of the infection were achieved in all patients, along with the normalization of clinical and radiologic parameters. In the patient who underwent a talectomy, one of the calcaneal locking screws broke, with no clinical repercussions.Conclusion:Tibiotalocalcaneal fusion with antibiotic cement-coated retrograde nails was useful in providing clinically acceptable results in the control of chronic infection in complex patients after the failure of previous surgeries.Level of Evidence:Level IV, therapeutic study.

Background Edge stenoses are the predominant limitation of self-expanding covered stent treatment of superficial femoral artery (SFA) occlusive disease, necessitating reinterventions. Angioplasty of an edge stenosis is associated with a high recurrence rate. Drug-coated balloon (DCB) treatment of edge stenoses might improve outcomes by decreasing the incidence of restenosis. Purpose The aim of this study was to evaluate the outcomes of using a DCB for the treatment of edge stenoses after self-expanding covered stent placement for SFA occlusive disease. Method We performed a retrospective analysis of patients treated with a DCB for edge stenoses after self-expanding covered stent placement. The primary endpoint was primary patency at one year. The secondary endpoints included procedure-related complications, secondary patency, and freedom from target lesion revascularization (TLR). Results A total of 21 patients with 28 edge stenoses were included. The time from primary treatment to treatment of the edge stenosis was 19 months (interquartile range (IQR) 8; 52 months). Primary patency and assisted primary patency at one year were 66.7% with a secondary patency of 90.9%. Freedom from TLR was 86.1%, and freedom from clinically driven TLR was 89.4%. Four patients presented with a hemodynamically significant restenosis, and three of those patients had an occlusion. Median time to failure was six months (IQR 3.5; 7.0 months), and median time to occlusion was four months (IQR 3.0; 6.0 months). Conclusion The treatment of edge stenoses using a DCB is associated with a safe one-year outcome; however, this has to be confirmed in larger prospective studies. The continuous surveillance of patients is indicated.

Purpose: To report the 36-month outcomes from the prospective, multicenter, single-arm IN.PACT Global Study ( ClinicalTrials.gov identifier NCT01609296) evaluating the performance of the IN.PACT Admiral drug-coated balloon (DCB) in real-world patients with femoropopliteal occlusive disease. Materials and Methods: The IN.PACT Global Study was conducted at 64 international sites and enrolled 1535 patients with complex lesions, which included bilateral disease, multiple lesions, de novo in-stent restenosis, long lesions, and chronic total occlusions. The predefined full clinical cohort included 1406 patients (mean age 68.6 years; 67.8% men) with claudication or rest pain treated with the study DCB. Mean lesion length was 12.09±9.54 cm; 18.0% had in-stent restenosis, 35.5% were totally occluded, and 68.7% were calcified. Freedom from clinically-driven target lesion revascularization (CD-TLR) was evaluated through 36 months. The safety composite endpoint was freedom from device- and procedure-related death through 30 days and freedom from major target limb amputation and clinically-driven target vessel revascularization within 36 months. All safety and revascularization events were reviewed by an independent clinical events committee. Results: The Kaplan-Meier estimate of freedom from CD-TLR through 36 months was 76.9%. The composite safety endpoint was achieved in 75.6% of patients. The 36-month all-cause mortality rate was 11.6%, and the major target limb amputation rate was 1.0%. The Kaplan-Meier estimate of freedom from CD-TLR through 36 months was significantly lower in patients with chronic limb-threatening ischemia (CLTI) compared with claudicants (67.6% vs 78.0%; p=0.003). Lesions affecting both the superficial femoral artery (SFA) and popliteal artery had lower Kaplan-Meier freedom from CD-TLR through 36 months (69.2%) than either isolated SFA (79.7%) or popliteal artery lesions (76.5%; log- rank p

The creation of in vitro functional hepatic tissue simulating micro environmental niche of the native liver is a keen area of research due to its demand in bioartificial liver. However, it is still unclear how to maintain benign cell function while achieving the sufficient cell quantity. In this work, we aim to prepare a novel scaffold for the culture of HepG2 cells, a liver cell line, by modifying polyvinyl alcohol (PVA) scaffold with collagen (COL). PVA is a kind of synthetic biostable polymer with high hydrophilicity in the human body, has been widely used in the biomedical field. However, the use of PVA is limited in cell cultures due to lack of biologically active functional groups. In this study, amino silane (KH-550), glutaraldehyde and native type I collagen were used to modify three-dimensional PVA scaffold to establish a suitable composite scaffold for hepatocyte culture. Three types of composite scaffolds were prepared for different collagen content, named as PVA/COL (0.2%), PVA/COL (0.5%) and PVA/COL (0.8%), respectively. The composite scaffolds were characterized by SEM, XPS, FTIR, MS, porosity estimation and water contact angle measurement. The PVA/COL (0.8%) scaffolds had the highest collagen content of 12.13%. The composite scaffold showed high porosity with interconnected pores. Furthermore, the biocompatibility between HepG2 cells and scaffolds was evaluated by the ability of cell proliferation, albumin secretion, as well as urea synthesis. The coating of collagen on PVA scaffolds promoted hydrophilicity and HepG2 cell adhesion. Additionally, enhanced cell proliferation, increased albumin secretion and urea synthesis were observed in HepG2 cells growing on collagen-coated three-dimensional PVA scaffolds.

Purpose: To investigate the safety and efficacy of drug-coated balloons (DCB) for the treatment of femoropopliteal or infrapopliteal lesions in patients with chronic limb-threatening ischemia (CLTI). Materials and Methods: A systematic literature search was conducted in PubMed, Scopus, and Cochrane Central up to January 2020 to identify randomized trials and observational studies presenting data on the effectiveness and safety of DCBs in the treatment of femoropopliteal or infrapopliteal lesions. A meta-analysis utilizing random effects modeling was conducted to investigate primary patency and all-cause mortality at 12 months; the results are reported as the odds ratios (ORs) and 95% confidence intervals (CIs). Secondary outcomes were procedural success, bailout stenting, target lesion revascularization (TLR), reocclusion, major amputation, wound healing, and major adverse limb events. Results: Twenty-six studies, 12 retrospective and 14 prospective, comprising 2108 CLTI patients treated with DCBs for femoropopliteal (n=1315) or infrapopliteal (n=793) lesions were analyzed. The average lesion lengths were 121±44 and 135±53 mm, respectively. The overall 12-month all-cause mortality and major amputation rates were 9% (95% CI 6% to 13%) and 5% (95% CI 2% to 8%), respectively. Primary patency rates were 82% (95% CI 76% to 87%) and 64% (95% CI 58% to 70%), respectively. A sensitivity analysis of the infrapopliteal lesions demonstrated no difference between DCB and balloon angioplasty in terms of primary patency, TLR, major amputation, or mortality over 12 months. However, patients with infrapopliteal lesions undergoing DCB angioplasty did have a significantly lower risk for reocclusion (10% vs 25%; OR 0.38, 95% CI 0.21 to 0.70, p=0.002). Conclusion: DCB angioplasty of femoropopliteal and infrapopliteal lesions in patients with CLTI results in acceptable 12-month patency rates, although comparative data have not shown a patency benefit for infrapopliteal lesions. The 12-month mortality rate of DCB vs balloon angioplasty was not significantly different, but studies with longer-term outcomes are necessary to determine any association between DCB use and mortality in patients with CLTI.

Orthopaedic metallic implant’s long-term success strongly depends upon the two main factors: osseointegration and antibacterial character. Bioceramic (hydroxyapatite and hopeite) coatings have been proven effective for getting strong osseointegration and antibacterial character. However, deterioration of bioceramic coatings during the implantation period can adversely affect its overall biological performance. To conquer this issue, this research work recommends an innovative process route of laser rapid manufacturing for depositing bioceramic (hydroxyapatite and hopeite) coatings with metallurgical bonding. Microstructure, phase composition, antibacterial efficacy and bioactivity were evaluated using scanning electron microscopy, X-ray diffraction, fluorescence-activated cell sorting technique and simulated body fluid immersion test. The promising results obtained from these characterizations and testing establish the new process route laser rapid manufacturing as an effective alternative to deposit multifunctional bioceramic (hydroxyapatite and hopeite) coatings on metallic prosthetic–orthopaedic implants.