New biodegradable intravascular stent can reduce risk of foreign bodies retained, thus, it is widely concerned and some of the products have been introduced into the clinic. However, the characteristic of biodegradable may lead to more safety concerns associated with thrombosis. To ensure the safety, the thrombus formation experiment needs to be carefully designed and evaluated based on GB/T 16886.4 standard, but current standard do not provide explicit testing and evaluating methods. Establishing animal model with experimental pigs, the study compares biodegradable coronary stents and metal stents by simulating clinical implantation on the thrombus formation in the implanting process, and after the short-term and long-term implantation. The evaluation methods include gross observation, digital subtraction angiography intraoperative analysis, optical coherence tomography analysis, scanning electron microscopy and so on. The results show that combining these methods could comprehensively evaluate the whole process of the thrombus formation from the beginning of implantation to the end of preclinical animal experiments, so that, it may better predict the clinical thrombosis risk, and the selection of the control was very important. The study tries to use the comparison examples of thrombosis on the new medical instrument to provide the clue for thrombosis evaluation on similar instruments and show the methodology on the preclinical evaluation.
Absorbable Implants ; adverse effects ; Animals ; Drug-Eluting Stents ; adverse effects ; Polymers ; Swine ; Thrombosis ; etiology ; Tomography, Optical Coherence ; Treatment Outcome

We conducted studies to confirm the hypothesis that the cellular damage occurring around implanted biphasic bioceramics could be related to a micro-particles release because of an insufficient sintering. An in vitro cytotoxicity study was performed on four biphasic ceramic (BCP) samples. Without the treatment of extraction medium, a cytotoxicity was observed, although after centrifugation this cytotoxicity disappeared in all samples. (2) Micro-particles of HA, beta-TCP and 40%beta-TCP/60%HA mixture were used for a cell inhibition study. A decrease of cell viability was observed with the increase in particles concentration. At 10000 particles/ cell, the viability and proliferation were completely inhibited. (3) HA, beta-TCP and BCP ceramic granules were implanted in rabbit femoral cavities for 12 weeks. No degradation of HA granules was observed. The degradation was higher for beta-TCP (40%) than for BCP (5%). On the other hand, new bone formation was significantly higher for beta-TCP (21%) and HA (18%) than for BCP (12%). Much more micro-particles were formed around BCP granules than around beta-TCP, and were phagocytosed by macrophages. The release of ceramic micro-particles could be related to the sintering process. BCP ceramics have to be sintered at only 1160 degrees C. Consequently, HA microparticles of BCP ceramic are incompletely sintered and easily released after immersion or implantation. The microparticles could be at the origin of local inflammation and cell damage and could perhaps modify osteogenesis. Particular attention must be paid to this problem with regard to BCP ceramics because of the sintering difficulties of this bioceramic.
Biocompatible Materials ; adverse effects ; chemistry ; Calcium Phosphates ; adverse effects ; chemistry ; Cells, Cultured ; Ceramics ; adverse effects ; chemistry ; Fibroblasts ; cytology ; drug effects ; Hydroxyapatites ; adverse effects ; chemistry ; Materials Testing ; Particle Size ; Prostheses and Implants ; adverse effects

Good anticoagulant biomaterials need good surface chemical properties, good mechanics performances and particularly good characteristics of biocompatibility, including tissue compatibility and hemocompatibility. In order to understand with greater clearness the anticoagulant biomaterial, we have to characterize them by different methods. In this paper, the approaches to assessing and displaying the characteristics of anticoagulant biomaterial are reviewed in three aspects, namely the surface chemical properties and structure, the mechanics performances the and the biocompatibility of anticoagulant biomaterial.
Anticoagulants ; Biocompatible Materials ; chemistry ; Blood Coagulation ; drug effects ; Humans ; Materials Testing ; Prostheses and Implants ; adverse effects ; Prosthesis Design ; Surface Properties

OBJECTIVETo evaluate the clinical outcome and the effects of treating peri-implantitis with periocline.

METHODSThirty-two sites in 32 implants with peri-implantitis were treated with periocline. The parameters including plaque index, probing depth (PD) of pocket, sulcular bleeding index (SBI) were measured at baseline, 1, 3, 6 and 12 weeks after treatment and followed up for 6 months.

RESULTSStatistically significant decrease (P < 0.05) in SBI, and PD occurred at all time intervals compared to baseline. The treatment could last for at lest four weeks in peri-implantitis cases without fistula.

CONCLUSIONSPeriocline could be safely and effectively used in treating peri-implantitis in cases without peri-implant fistula. Peri-implantitis with fistula should be treated in combination with surgical methods, and periocline can also be used to control inflammation before surgery.

Adult ; Anti-Bacterial Agents ; therapeutic use ; Dental Implantation, Endosseous ; adverse effects ; Dental Implants ; adverse effects ; Female ; Humans ; Male ; Middle Aged ; Minocycline ; therapeutic use ; Periodontitis ; drug therapy ; etiology

BACKGROUND: There are few data comparing clinical outcomes of complex percutaneous coronary intervention (CPCI) when using biodegradable polymer drug-eluting stents (BP-DES) or second-generation durable polymer drug-eluting stents (DP-DES). The purpose of this study was to investigate the safety and efficacy of BP-DES and compare that with DP-DES in patients with and without CPCI during a 5-year follow-up. METHODS: Patients who exclusively underwent BP-DES or DP-DES implantation in 2013 at Fuwai Hospital were consecutively enrolled and stratified into two categories based on CPCI presence or absence. CPCI included at least one of the following features: unprotected left main lesion, ≥2 lesions treated, ≥2 stents implanted, total stent length >40 mm, moderate-to-severe calcified lesion, chronic total occlusion, or bifurcated target lesion. The primary endpoint was major adverse cardiac events (MACE) including all-cause death, recurrent myocardial infarction, and total coronary revascularization (target lesion revascularization, target vessel revascularization [TVR], and non-TVR) during the 5-year follow-up. The secondary endpoint was total coronary revascularization. RESULTS: Among the 7712 patients included, 4882 (63.3%) underwent CPCI. Compared with non-CPCI patients, CPCI patients had higher 2- and 5-year incidences of MACE and total coronary revascularization. Following multivariable adjustment including stent type, CPCI was an independent predictor of MACE (adjusted hazard ratio [aHR]: 1.151; 95% confidence interval [CI]: 1.017-1.303, P  = 0.026) and total coronary revascularization (aHR: 1.199; 95% CI: 1.037-1.388, P  = 0.014) at 5 years. The results were consistent at the 2-year endpoints. In patients with CPCI, BP-DES use was associated with significantly higher MACE rates at 5 years (aHR: 1.256; 95% CI: 1.078-1.462, P  = 0.003) and total coronary revascularization (aHR: 1.257; 95% CI: 1.052-1.502, P  = 0.012) compared with that of DP-DES, but there was a similar risk at 2 years. However, BP-DES had comparable safety and efficacy profiles including MACE and total coronary revascularization compared with DP-DES in patients with non-CPCI at 2 and 5 years. CONCLUSIONS Patients underwent CPCI remained at a higher risk of mid- to long-term adverse events regardless of the stent type. The effect of BP-DES compared with DP-DES on outcomes was similar in CPCI and non-CPCI patients at 2 years but had inconsistent effects at the 5-year clinical endpoints.
Humans ; Drug-Eluting Stents/adverse effects* ; Myocardial Infarction/complications* ; Polymers/therapeutic use* ; Treatment Outcome ; Coronary Artery Disease/complications* ; Percutaneous Coronary Intervention/adverse effects* ; Absorbable Implants ; Prosthesis Design

BACKGROUNDPretreatment with chemical agents could alter the surface chemistry of the silicone gel, which makes it suitable for epithelial migration onto its surface and thus enhances the cytobiocompatibility. This study aimed to evaluate the biological response of the corneal stroma to porous silicone gel pretreated with different chemical agents in vivo.

METHODSThe porous silicone gels were treated with a mixed acid solution containing 23.2% H2SO4 and 0.8% K2Cr2O7 for 10 or 15 minutes or with 30% H2O2 for 15 minutes. Discs (4 mm in diameter) were inserted into interlamellar stromal pockets of New Zealand white rabbits and followed up for a period of 3 months. Clinical evaluations such as corneal infiltration, edema and neovascularization were performed daily. At 3 months, the fibroplasias and collagen deposition were examined under light and scanning electron microscopy (SEM) and by immunohistochemical analysis.

RESULTSPretreatment of the discs obviously decreased conjunctival congestion, discharge, cornea edema, and the extent of neovascularization. More fibroblasts migrated into the pretreated discs than into the control, and collagen was deposited, indicating that the biocompatibility of the corneal replacements was enhanced by the chemical pretreatments. From immunohistochemical analysis, Type I collagen deposition in the pretreated silicone discs was greater than in the control.

CONCLUSIONSChemical treatment of silicone gel is effective in decreasing rabbit corneal inflammation, encouraging fibroblast in-growth, and enhancing tissue compatibility. Pretreated gels show good biological stability when used as a skirt material in Keratoprosthesis (Kpros).

Animals ; Biocompatible Materials ; adverse effects ; chemistry ; Cornea ; drug effects ; ultrastructure ; Corneal Edema ; etiology ; Corneal Stroma ; drug effects ; Microscopy, Electron, Scanning ; Porosity ; Prostheses and Implants ; Rabbits ; Silicone Gels ; adverse effects ; chemistry

A variety of methods for testosterone replacement therapy (TRT) exist, and the major potential risks of TRT have been well established. The risk of developing polycythemia secondary to exogenous testosterone (T) has been reported to range from 0.4% to 40%. Implantable T pellets have been used since 1972, and secondary polycythemia has been reported to be as low as 0.4% with this administration modality. However, our experience has suggested a higher rate. We conducted an institutional review board-approved, single-institution, retrospective chart review (2009-2013) to determine the rate of secondary polycythemia in 228 men treated with subcutaneously implanted testosterone pellets. Kaplan-Meyer failure curves were used to estimate time until the development of polycythemia (hematocrit >50%). The mean number of pellets administered was 12 (range: 6-16). The mean follow-up was 566 days. The median time to development of polycythemia whereby 50% of patients developed polycythemia was 50 months. The estimated rate of polycythemia at 6 months was 10.4%, 12 months was 17.3%, and 24 months was 30.2%. We concluded that the incidence of secondary polycythemia while on T pellet therapy may be higher than previously established.
Adult ; Aged ; Androgens/adverse effects* ; Drug Implants ; Hematocrit ; Hormone Replacement Therapy/methods* ; Humans ; Hypogonadism/drug therapy* ; Kaplan-Meier Estimate ; Male ; Middle Aged ; Polycythemia/epidemiology* ; Retrospective Studies ; Testosterone/adverse effects*

A 58-year-old man admitted to our opthalmology department with the complaint of branch retinal vein occlusion. He was treated with intravitreal Ozurdex in the right eye. Two days after the injection, the patient presented with ocular pain and the visual acuity was hand movement. A diagnosis of endophthalmitis was made. We performed emergent pars plana vitrectomy (PPV) and the implant was removed from the vitreous cavity using a retinal forceps. A combination of vancomycin 1.0 mg and amikacin 0.4 mg was injected intravitreally. However, because of the blurring in the vitreus one week after the procedure, phacoemulsification and a repeat PPV was performed. Five days after the last procedure the signs and symptoms of endophthalmitis were resolved. Our case demonstrated that endophthalmitis could develop after intravitreal implantation of Ozurdex. Surgical removal of the implant and immediate vitrectomy seems to be a useful treatment option in these cases.
Device Removal/methods ; Dexamethasone/administration & dosage/*adverse effects ; Diagnosis, Differential ; Drug Implants/*adverse effects ; Endophthalmitis/diagnosis/*etiology/surgery ; Eye Infections, Bacterial/diagnosis/*etiology/surgery ; Glucocorticoids/administration & dosage/adverse effects ; Humans ; Intravitreal Injections/adverse effects ; Male ; Middle Aged ; Retinal Vein Occlusion/diagnosis/*drug therapy ; Vitrectomy

BACKGROUNDThe difference in clinical outcome between paclitaxal-eluting stents (PES) and sirolimus-eluting stents with bio-degradable polymer (SES-BDP) for bifurcation lesions remains unclear. The present study aimed to investigate the one-year clinical outcome after DK crush stenting using PES (Taxus(TM)) vs. SES-BDP (Excel(TM)) from our database.

METHODSA total of 275 patients (90 from the DKCRUSH-I and 185 from the DKCRUSH-II study) were studied. The primary endpoint was the occurrence of major adverse cardiac events (MACE) at 12 months; including cardiac death, myocardial infarction (MI), or target vessel revascularization (TVR). The rate of binary restenosis and stent thrombosis served as secondary endpoints.

RESULTSAt follow-up, minimal luminal diameter (MLD) in the Taxus group was (2.11 ± 0.66) mm, with resultant increased target lesion revascularization (TLR) 12.2% and TVR 14.4%, significantly different from the Excel group; (2.47 ± 0.56) mm, P < 0.001, 3.2%, P = 0.006, 4.9%, P = 0.019, respectively. As a result there was a significant difference in MACE between the Taxus (20.0%) and Excel (10.3%, P = 0.038) groups. Overall stent thrombosis was monitored in 11 patients (4.0%), with five in the Excel group (2.7%) and six in the Taxus group (6.7%). All stent thrombosis in the Excel group was classified as early, and all were defined as late in the Taxus group.

CONCLUSIONThe Excel stent had lower rate of stent thrombosis, TLR, TVR, and composite MACE at 12-month after an indexed stenting procedure, compared to the Taxus stent.

Absorbable Implants ; Aged ; Coronary Artery Disease ; therapy ; Drug-Eluting Stents ; adverse effects ; Female ; Humans ; Male ; Middle Aged ; Paclitaxel ; therapeutic use ; Polymers ; Sirolimus ; therapeutic use

OBJECTIVETo observe the curative effect of porous tantalum rod and Gugutou Huaisiyu Capsule (GHC) for steroid-induced osteonecrosis of femoral head (SONFH).

METHODSA total 60 hips of 50 SONFH patients were randomly assigned to the treatment group and the control group according to grouping time, 25 in each group (30 hips). Patients in the control group were implanted with porous tantalum rod, while those in the treatment group additionally took GHC (5 pills each time, three time per day for 2 successive months; and then twice per day for 4 successive months). Then all patients were followed-up to observe Harris hip score. The curative effect and the femoral head survival time were assessed.

RESULTSA total of 49 patients (59 hips) were followed-up. The Harris hip score of the two groups at the final follow-up was significantly improved after treatment, with statistical difference when compared with before treatment (P < 0.01). Besides, it was higher in the treatment group than in the control group. The curative effect and the survival time were superior in the treatment group, with statistical difference when compared with the control group (P < 0.05).

CONCLUSIONSPorous tantalum rod combined GHC got better effect in treating SONFH. It could significantly improve the function of affected hips and prolong the survival time of femoral head.

Capsules ; Drugs, Chinese Herbal ; administration & dosage ; pharmacology ; therapeutic use ; Femur Head Necrosis ; drug therapy ; Humans ; Prostheses and Implants ; Steroids ; adverse effects ; Tantalum