Effects of cobalt-chromium everolimus eluting stents or bare metal stent on fatal and non-fatal cardiovascular events: patient level meta-analysis

Objectives: To examine the safety and effectiveness of cobalt-chromium everolimus eluting stents compared with bare metal stents. Design: Individual patient data meta-analysis of randomised controlled trials. Cox proportional regression models stratified by trial, containing random effects, were used to assess the impact of stent type on outcomes. Hazard ratios with 95% confidence interval for outcomes were reported. Data sources and study selection: Medline, Embase, the Cochrane Central Register of Controlled Trials. Randomised controlled trials that compared cobalt-chromium everolimus eluting stents with bare metal stents were selected. The principal investigators whose trials met the inclusion criteria provided data for individual patients. Primary outcomes: The primary outcome was cardiac mortality. Secondary endpoints were myocardial infarction, definite stent thrombosis, definite or probable stent thrombosis, target vessel revascularisation, and all cause death. Results: The search yielded five randomised controlled trials, comprising 4896 participants. Compared with patients receiving bare metal stents, participants receiving cobalt-chromium everolimus eluting stents had a significant reduction of cardiac mortality (hazard ratio 0.67, 95% confidence interval 0.49 to 0.91; P=0.01), myocardial infarction (0.71, 0.55 to 0.92; P=0.01), definite stent thrombosis (0.41, 0.22 to 0.76; P=0.005), definite or probable stent thrombosis (0.48, 0.31 to 0.73; P<0.001), and target vessel revascularisation (0.29, 0.20 to 0.41; P<0.001) at a median follow-up of 720 days. There was no significant difference in all cause death between groups (0.83, 0.65 to 1.06; P=0.14). Findings remained unchanged at multivariable regression after adjustment for the acuity of clinical syndrome (for instance, acute coronary syndrome v stable coronary artery disease), diabetes mellitus, female sex, use of glycoprotein IIb/IIIa inhibitors, and up to one year v longer duration treatment with dual antiplatelets. Conclusions: This meta-analysis offers evidence that compared with bare metal stents the use of cobalt-chromium everolimus eluting stents improves global cardiovascular outcomes including cardiac survival, myocardial infarction, and overall stent thrombosis.

Effects of cobalt-chromium everolimus eluting stents or bare metal stent on fatal and non-fatal cardiovascular events: patient level meta-analysis

Objectives: To examine the safety and effectiveness of cobalt-chromium everolimus eluting stents compared with bare metal stents. Design: Individual patient data meta-analysis of randomised controlled trials. Cox proportional regression models stratified by trial, containing random effects, were used to assess the impact of stent type on outcomes. Hazard ratios with 95% confidence interval for outcomes were reported. Data sources and study selection: Medline, Embase, the Cochrane Central Register of Controlled Trials. Randomised controlled trials that compared cobalt-chromium everolimus eluting stents with bare metal stents were selected. The principal investigators whose trials met the inclusion criteria provided data for individual patients. Primary outcomes: The primary outcome was cardiac mortality. Secondary endpoints were myocardial infarction, definite stent thrombosis, definite or probable stent thrombosis, target vessel revascularisation, and all cause death. Results: The search yielded five randomised controlled trials, comprising 4896 participants. Compared with patients receiving bare metal stents, participants receiving cobalt-chromium everolimus eluting stents had a significant reduction of cardiac mortality (hazard ratio 0.67, 95% confidence interval 0.49 to 0.91; P=0.01), myocardial infarction (0.71, 0.55 to 0.92; P=0.01), definite stent thrombosis (0.41, 0.22 to 0.76; P=0.005), definite or probable stent thrombosis (0.48, 0.31 to 0.73; P<0.001), and target vessel revascularisation (0.29, 0.20 to 0.41; P<0.001) at a median follow-up of 720 days. There was no significant difference in all cause death between groups (0.83, 0.65 to 1.06; P=0.14). Findings remained unchanged at multivariable regression after adjustment for the acuity of clinical syndrome (for instance, acute coronary syndrome v stable coronary artery disease), diabetes mellitus, female sex, use of glycoprotein IIb/IIIa inhibitors, and up to one year v longer duration treatment with dual antiplatelets. Conclusions: This meta-analysis offers evidence that compared with bare metal stents the use of cobalt-chromium everolimus eluting stents improves global cardiovascular outcomes including cardiac survival, myocardial infarction, and overall stent thrombosis.

Use of fiber-reinforced composite framework and thermochromic pigment in maxillofacial prostheses

The purpose of this investigation was to evaluate the possibility to enhance certain qualities of facial prostheses. Polymethyl methacrylate is still being used as base mate¬rial or clip carrier material, but it is hard and heavy, and debonding of the silicone from the acrylic base material is a frequent problem. This thesis aims to evaluate the use of fiber-reinforced composite (FRC) as framework material for maxillofacial silicone prostheses. FRC has been used as reinforcement in removable and fixed partial dentures since the 1990s. This material is lightweight and can be fabricated to compress the margins of the prosthesis slightly, to keep it tightly against the skin during jaw movements and facial expressions. Additionally, the use of a thermochromic pigment, colorless in room temperature and red in a cold environment, was studied in order to evaluate the possibility of using this color changing pigment in facial prostheses to mimic the color change of facial skin in cold weather. The tensile bond strength between pre-impregnated, unidirectional FRC and maxillofacial silicone elastomer was studied. Three different bonding agents or primers were compared. Bond strength was improved by one of the primers and by roughening the surface. The effect of a skin compressing glass fiber-reinforced composite framework on facial skin blood flow was studied by using a face mask, constructed with a compression pad corresponding to the outer margin of a glass fiber-reinforced framework beam of a facial prosthesis. The skin blood flow of ten healthy volunteers, aged 23-25 years, was measured during touch, light, and moderate compression of the skin, by using laser Doppler imaging technique. None of the compressions showed any marked effects on local skin blood flow. There were no significant differences between blood flow during compression and at baseline. Maxillofacial silicone elastomer was colored intrinsically with conventional color pigments: a control group containing only conventional pigments was compared to two test groups with 0.2 wt% and 0.6 wt% thermochromic pigment added. The color of the material was measured with a spectrophotometer in room temperature and after storage in a freezer. The color stability of the maxillofacial silicone elastomer colored with thermo¬chromic pigment was evaluated by artificial aging. The color dif¬ference of the L* (lightness) and a* values (redness), comparing color after the samples were stored at room temperature and in a freezer (-19°C), was statistically significant for both 0.2 wt% and 0.6 wt% thermo¬chromic pigment groups. The differences in the b* values (yellowness) were statistically significant for the 0.6 wt% group. Exposure to ultraviolet (UV) radiation led to visually noticeable and statistically signifi¬cant color changes (ΔE) in all color values in both test groups. The specimens containing thermochromic pigment were very sensitive to UV radiation. In conclusion, a framework of fiber-reinforced composite can successfully be bonded to maxillofacial silicone elastomer, and a framework beam, compressing the facial skin, did not remarkably alter the skin blood flow on healthy, young adults. The thermochromic pigment showed color change in maxillofacial silicone elastomer. However, artificial aging showed that it was too sensitive to UV radiation to be used, as such, in maxillofacial prostheses.

Predictors of restenosis after percutaneous coronary intervention using bare-metal stents: a comparison between patients with and without dysglycemia

The objective of this study was to identify intravascular ultrasound (IVUS), angiographic and metabolic parameters related to restenosis in patients with dysglycemia. Seventy consecutive patients (77 lesions) selected according to inclusion and exclusion criteria were evaluated by the oral glucose tolerance test and the determination of insulinemia after a successful percutaneous coronary intervention (PCI) with a bare-metal stent. The degree of insulin resistance was calculated by the homeostasis model assessment of insulin resistance (HOMA-IR). Six-month IVUS and angiogram follow-up were performed. Thirty-nine patients (55.7%) had dysglycemia. The restenosis rate in the dysglycemic group was 37.2 vs 23.5% in the euglycemic group (P = 0.299). The predictors of restenosis using bivariate analysis were reference vessel diameter (RVD): £2.93 mm (RR = 0.54; 95%CI = 0.05-0.78; P = 0.048), stent area (SA): <8.91 mm² (RR = 0.66; 95%CI = 0.24-0.85; P = 0.006), stent volume (SV): <119.75 mm³ (RR = 0.74; 95%CI = 0.38-0.89; P = 0.0005), HOMA-IR: >2.063 (RR = 0.44; 95%CI = 0.14-0.64; P = 0.027), and fasting plasma glucose (FPG): ≤108.8 mg/dL (RR = 0.53; 95%CI = 0.13-0.75; P = 0.046). SV was an independent predictor of restenosis by multivariable analysis. Dysglycemia is a common clinical condition in patients submitted to PCI. The degree of insulin resistance, FPG, RVD, SA, and SV were correlated with restenosis. SV was inversely correlated with an independent predictor of restenosis in patients treated with a bare-metal stent.

A comparison of the Oxford and Manus intelligent hand prostheses

Historically, commercial hand prosthesis have adopted a low level of innovation mainly due to the strict conditions such a system must undergo. The difficult feedback to the prosthesis user has limited the functional range of commercial systems. Nevertheless, the use of advanced sensors in combination with performing hand mechanisms and microcontrollers could lead to more natural and functional prototypes. The Oxford and Manus intelligent hand prostheses are examples of innovative approaches. This paper compares and contrasts the technological solutions implemented in both systems to address the design conditions.

Effect of cantilever length and framework alloy on the stress distribution of mandibular-cantilevered implant-supported prostheses

Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq)

Influence of the Connector and Implant Design on the Implant-Tooth-Connected Prostheses

Purpose:The purpose of this study was to evaluate stress transfer patterns between implant-tooth-connected prostheses comparing rigid and semirigid connectors and internal and external hexagon implants.Materials and Methods:Two models were made of photoelastic resin PL-2, with an internal hexagon implant of 4.00 x 13 mm and another with an external hexagon implant of 4.00 x 13 mm. Three denture designs were fabricated for each implant model, incorporating one type of connection in each one to connect implants and teeth: 1) welded rigid connection; 2) semirigid connection; and 3) rigid connection with occlusal screw. The models were placed in the polariscope, and 100-N axial forces were applied on fixed points on the occlusal surface of the dentures.Results:There was a trend toward less intensity in the stresses on the semirigid connection and solid rigid connection in the model with the external hexagon; among the three types of connections in the model with the internal hexagon implant, the semirigid connection was the most unfavorable one; in the tooth-implant association, it is preferable to use the external hexagon implant.Conclusions:The internal hexagon implant establishes a greater depth of hexagon retention and an increase in the level of denture stability in comparison with the implant with the external hexagon. However, this greater stability of the internal hexagon generated greater stresses in the abutment structures. Therefore, when this association is necessary, it is preferable to use the external hexagon implant.

Photoelastic Stress Analysis of Different Attachment Systems on Implant-Retained and Conventional Palatal Obturator Prostheses

Background: Considering that an increasing number of patients are victims of mutilator surgical resections, these studies are important for treatment success of rehabilitation of patients presenting oronasal communication.Purpose: The aim of this study was to assess the stress distribution through photoelasticity in palatal obturator prostheses with different attachment systems for implants.Methods: Two photoelastic models were obtained from an experimental maxillary model presenting an oronasal communication. One model was fabricated without implant, and the other with 2 implants 10 mm in length inserted in the left crest. Four colorless palatal obturator prostheses were fabricated. One prosthesis presented no attachment system, whereas the remaining prostheses were adapted to 3 attachment systems. The assembly was positioned in a circular polariscope for application of axial load.Results: The results were based on photographic records of stress in the photoelastic model submitted to loading. The records revealed higher stress concentration on the bar-clip system followed by the O'ring/bar-clip and O'ring systems, respectively. A homogeneous stress distribution was observed on the photoelastic model with the mucous-supported prosthesis.Conclusions: The attachment systems generated different characteristics of stress distribution that was concentrated surrounding the implants. The bar-clip system exhibited the highest stress concentration on the alveolar crest.

Three-Dimensional Finite Element Analysis of Vertical and Angular Misfit in Implant-Supported Fixed Prostheses

Purpose: Three-dimensional finite element analysis was used to evaluate the effect of vertical and angular misfit in three-piece implant-supported screw-retained fixed prostheses on the biomechanical response in the peri-implant bone, implants, and prosthetic components. Materials and Methods: Four three-dimensional models were fabricated to represent a right posterior mandibular section with one implant in the region of the second premolar (2PM) and another in the region of the second molar (2M). The implants were splinted by a three-piece implant-supported metal-ceramic prosthesis and differed according to the type of misfit, as represented by four different models: Control = prosthesis with complete fit to the implants; UAM (unilateral angular misfit) = prosthesis presenting unilateral angular misfit of 100 pm in the mesial region of the 2M; UVM (unilateral vertical misfit) = prosthesis presenting unilateral vertical misfit of 100 pm in the mesial region of the 2M; and TVM (total vertical misfit) = prosthesis presenting total vertical misfit of 100 pm in the platform of the framework in the 2M. A vertical load of 400 N was distributed and applied on 12 centric points by the software Ansys, ie, a vertical load of 150 N was applied to each molar in the prosthesis and a vertical load of 100 N was applied at the 2PM. Results: The stress values and distribution in peri-implant bone tissue were similar for all groups. The models with misfit exhibited different distribution patterns and increased stress magnitude in comparison to the control. The highest stress values in group UAM were observed in the implant body and retention screw. The groups UVM and TVM exhibited high stress values in the platform of the framework and the implant hexagon, respectively. Conclusions: The three types of misfit influenced the magnitude and distribution of stresses. The influence of misfit on peri-implant bone tissue was modest. Each type of misfit increased the stress values in different regions of the system. INT J ORAL MAXILLOFAC IMPLANTS 2011;26:788-796

Care and Cleaning of Maxillofacial Prostheses

Both the cleaning and care of the prosthesis are fundamental for maintaining its quality. Therefore, the aim of this study was to show the methods of cleaning and care the patient needs to take as regards the prosthesis and adjacent tissue, starting with correct instruction and training by the professional. It has been verified that among the materials for fabricating maxillofacial prostheses, silicone was considered the major retainer of microorganisms on its surface. Therefore, for cleaning prostheses, the use of water and neutral soap, as well as chlorhexidine, is recommended. As regards care of the adjacent tissues, it is recommended to remove the prosthesis before going to sleep, in addition to washing the prosthesis receptor tissues with water and neutral soap or with a mixture of hydrogen peroxide and water. Whereas for the mucosal surfaces of the ophthalmic cavity, cleaning with filtered and boiled water or physiological solution at least 3 times a day is recommended.

The Effect of Mechanical Cycling and Different Misfit Levels on Vicker's Microhardness of Retention Screws for Single Implant-Supported Prostheses

Purpose: The aim of this study was to evaluate the effect of mechanical cycling and different misfit levels on Vicker's microhardness of retention screws for single implant-supported prostheses.Materials and Methods: Premachined UCLA abutments were cast with cobalt-chromium alloy to obtain 48 crowns divided into four groups (n = 12). The crowns presented no misfit in group A (control group) and unilateral misfits of 50 mu m, 100 mu m, and 200 mu m in groups B, C, and D, respectively. The crowns were screwed to external hexagon implants with titanium retention screws (torque of 30 N/cm), and the sets were submitted to three different periods of mechanical cycling: 2 x 10(4), 5 x 10(4), and 1 x 10(6) cycles. Screw microhardness values were measured before and after each cycling period. Data were evaluated by two-way ANOVA and Tukey's test (p < 0.05).Results: Mechanical cycling statistically reduced microhardness values of retention screws regardless of cycling periods and groups. In groups A, B, and C, initial microhardness values were statistically different from final microhardness values (p < 0.05). There was no statistically significant difference for initial screw microhardness values (p > 0.05) among the groups; however, when the groups were compared after mechanical cycling, a statistically significant difference was observed between groups B and D (p < 0.05).Conclusions: Mechanical cycling reduced the Vicker's microhardness values of the retention screws of all groups. The crowns with the highest misfit level presented the highest Vicker's microhardness values.

Photoelastic Analysis of Biomechanical Behavior of Single and Multiple Fixed Partial Prostheses With Different Prosthetic Connections

Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP)

Methods Used for Assessing Stresses in Buccomaxillary Prostheses: Photoelasticity, Finite Element Technique, and Extensometry

The authors describe a literature revision on assessing stresses in buccomaxillary prostheses photoelasticity, finite element technique, and extensometry. They describe the techniques and the importance for use of each method in buccomaxillary prostheses with implants and the need of accomplishing more studies in this scarce literary area.

Photoelastic Analysis of Implant-Retained and Conventional Obturator Prostheses With Different Attachment Systems and Soft Relining

Complete and partial loss of maxillary bone may jeopardize oral physiology and generate complications as oral-sinus-nasal communication. Palatal obturator prostheses are a treatment alternative for rehabilitation of these patients. The aim of this study was to assess stress distribution, through photoelasticity, on palatal obturator prostheses associated with different attachment systems (o'ring, bar clip, and o'ring/bar clip) of implants and submitted to relining. Two photoelastic models were fabricated according to an experimental maxillary model with oral-sinus-nasal communication. One model did not present implants, whereas the other included 2 implants with 13.0 mm in length in the left ridge. Four colorless maxillary obturator prostheses were fabricated and relined with soft silicone. One of these prostheses presented no attachment system, whereas the remaining prostheses included attachment systems adapted to the implants. The assembly (model/attachment system/prosthesis) was positioned in a circular polariscope during loading with 100 N at 10 mm/s. The results were based on observation during the experiment and photographic records of stress on the photoelastic model. The bar clip system exhibited the highest stress concentration followed by o'ring/bar clip and o'ring systems. The attachment systems presented different stress distribution with greater concentration surrounding the implants and homogenous stress distribution on the photoelastic model without implants. The highest concentration of fringes occurred, in ascending order, with o'ring, o'ring/bar clip, and bar clip systems.