Multilevel Assessment of Stent-Induced Inflammation in the Adjacent Vascular Tissue.

A recent U.S. Food and Drug Administration report presented the currently available scientific information related to biological response to metal implants. In this work, a multilevel approach was employed to assess the implant-induced and biocorrosion-related inflammation in the adjacent vascular tissue using a mouse stent implantation model. The implications of biocorrosion on peri-implant tissue were assessed at the macroscopic level via in vivo imaging and histomorphology. Elevated matrix metalloproteinase activity, colocalized with the site of implantation, and histological staining indicated that stent surface condition and implantation time affect the inflammatory response and subsequent formation and extent of neointima. Hematological measurements also demonstrated that accumulated metal particle contamination in blood samples from corroded-stetted mice causes a stronger immune response. At the cellular level, the stent-induced alterations in the nanostructure, cytoskeleton, and mechanical properties of circulating lymphocytes were investigated. It was found that cells from corroded-stented samples exhibited higher stiffness, in terms of Young's modulus values, compared to noncorroded and sham-stented samples. Nanomechanical modifications were also accompanied by cellular remodeling, through alterations in cell morphology and stress (F-actin) fiber characteristics. Our analysis indicates that surface wear and elevated metal particle contamination, prompted by corroded stents, may contribute to the inflammatory response and the multifactorial process of in-stent restenosis. The results also suggest that circulating lymphocytes could be a novel nanomechanical biomarker for peri-implant tissue inflammation and possibly the early stage of in-stent restenosis. Large-scale studies are warranted to further investigate these findings.

Trunnion Corrosion in Total Hip Arthroplasty-Basic Concepts.

There has been increased interest in the role of corrosion in early implant failures and adverse local tissue reaction in total hip arthroplasty. We review the relationship between the different types of corrosion in orthopaedic surgery including uniform, pitting, crevice, and fretting or mechanically assisted crevice corrosion (MACC). Passive layer dynamics serves a critical role in each of these processes. The femoral head-neck trunnion creates an optimal environment for corrosion to occur because of the limited fluid diffusion, acidic environment, and increased bending moment.

Factors influencing the progression of noncarious cervical lesions: A 5-year prospective clinical evaluation.

STATEMENT OF PROBLEM: The etiology (chemical, friction, abfraction) of noncarious cervical lesion (NCCL) progression is poorly understood. PURPOSE: The purpose of this 5-year prospective clinical trial was to measure the relationship between NCCLs and various etiologic factors. MATERIAL AND METHODS: After review board approval, 29 participants with NCCLs were enrolled. Polyvinyl siloxane impressions were made of each NCCL, and casts were poured at baseline, 1, 2, and 5 years. The casts were scanned with a noncontact profilometer, and 1-, 2-, and 5-year scans were superimposed over baseline scans to measure volumetric change in NCCLs. T-scan and Fujifilm Prescale films were used to record relative and absolute occlusal forces on teeth with NCCLs at the 5-year recall. Participant diet, medical condition, toothbrushing, and adverse oral habit questionnaires were given at the 5-year recall. Occlusal analysis was completed on mounted casts to determine the presence of wear facets and group function. Volumetric lesion progression from 1 to 5 years was correlated to absolute and relative occlusal force using mixed model analysis. The Kruskall-Wallis and Mann-Whitney analyses compared lesion progression with diet, medical condition, toothbrushing, adverse oral habits, wear facets, and group function. RESULTS: The NCCL progression rate over 5 years was 1.50 ±0.92 mm(3)/yr. The rate of progression of NCCLs was related to mean occlusal stress (P=.011) and relative occlusal force (P=.032) in maximum intercuspation position. No difference was seen in NCCL progression between participants with any other factors. CONCLUSION: Heavy occlusal forces play a significant role in the progression of NCCLs.

In vivo monitoring of the inflammatory response in a stented mouse aorta model.

The popularity of vascular stents continues to increase for a variety of applications, including coronary, lower limb, renal, carotid, and neurovascular disorders. However, their clinical effectiveness is hindered by numerous postdeployment complications, which may stimulate inflammatory and fibrotic reactions. The purpose of this study was to evaluate the vessel inflammatory response via in vivo imaging in a mouse stent implantation model. Corroded and noncorroded self-expanding miniature nitinol stents were implanted in mice abdominal aortas, and novel in vivo imaging techniques were used to assess trafficking and accumulation of fluorescent donor monocytes as well as cellular proliferation at the implantation site. Monocytes were quantitatively tracked in vivo and found to rapidly clear from circulation within hours after injection. Differences were found between the test groups with respect to the numbers of recruited monocytes and the intensity of the resulting fluorescent signal. Image analysis also revealed a subtle increase in matrix metalloproteinase activity in corroded compared with the normal stented aortas. In conclusion, this study has been successful in developing a murine stent inflammation model and applying novel in vivo imaging tools and methods to monitor the complex biological processes of the host vascular wall response.

Effect of imaging powder and CAD/CAM stone types on the marginal gap of zirconia crowns.

OBJECTIVE: To compare the marginal gap using different types of die stones and titanium dies with and without powders for imaging. METHODS: A melamine tooth was prepared and scanned using a laboratory 3-shape scanner to mill a polyurethane die, which was duplicated into different stones (Jade, Lean, CEREC) and titanium. Each die was sprayed with imaging powders (NP, IPS, Optispray, Vita) to form 15 groups. Ten of each combination of stone/titanium and imaging powders were used to mill crowns. A light-bodied impression material was injected into the intaglio surface of each crown and placed on the corresponding die. Each crown was removed, and the monophase material was injected to form a monophase die, which was cut into 8 sections. Digital images were captured using a stereomicroscope to measure marginal gap. Scanning electron microscopy was used to determine the particle size and shape of imaging powders and stones. RESULTS: Marginal gaps ranged from mean (standard deviation) 49.32 to 1.20 micrometers (3.97-42.41 µm). There was no statistical difference (P > .05) in the marginal gap by any combination of stone/titanium and imaging powders. All of the imaging powders had a similar size and rounded shape, whereas the surface of the stones showed different structures. CONCLUSIONS: When a laboratory 3-shape scanner is used, all imaging powders performed the same for scanning titanium abutments. However, there was no added value related to the use of imaging powder on die stone. It is recommended that the selection of stone for a master cast be based on the hysical properties. PRACTICAL IMPLICATIONS: When a laboratory 3-shape scanner is used, the imaging powder is not required for scanning die stone. Whenever scanning titanium implant abutments, select the least expensive imaging powder.

Influence of implant angulation on the fracture resistance of zirconia abutments.

PURPOSE: To investigate the effects of abutment design to correct for implant angulation and aging on the fracture resistance of zirconia abutments. Greater understanding of the fracture strength of the zirconia abutments under various clinical conditions may lead to improvement of clinical protocols and possibly limit potential failures of implant prosthetics. MATERIALS AND METHODS: Test specimens consisted of an implant-zirconia abutment-zirconia crown assembly with implant apex positioned at 0°, 20° to the facial (20F), and 20° to the lingual (20L) with respect to a constant crown contour. To keep the abutment design as the only variable, CAD/CAM technology was used to generate monolithic zirconia crowns identical both in external and internal dimensions and marginal contours to precisely fit all the abutments in an identical fashion. The monolithic zirconia abutments were designed to fit the constant crown contours and the internal connection of the implant at the three angulations. The customized abutments for the three implant angulations varied in emergence profile, screw hole location, and material thickness around the screw hole. Half the specimens from each group were subjected to steam autoclaving and thermocycling to simulate aging of the restorations in vivo. To mimic the off-axis loading of the central incisor, the specimens were loaded at the recommended cephalometric interincisal relationship of 135° between the long axis of the crown supported by the implant and the Instron force applicator simulating the mandibular incisor. The force applicator was positioned 2 mm from the incisal edge and loaded at a 1 mm/min crosshead speed. Data were evaluated by 2-way ANOVA (α = 0.05) and Tukey's HSD. RESULTS: The 20F group had the highest fracture values followed by the 0° group, and the 20L group had the lowest fracture values. Aging did not yield any significant difference in fracture force magnitudes. CONCLUSION: Within the limitations of this study, tilting the implant apex to the lingual significantly reduced the fracture strength of angle-corrected zirconia abutments. Accordingly, while the angle between the occlusal force application and the long axis of the implant decreases, the resistance (force) to fracture decreases.

Multi-scale mechanical investigation of stainless steel and cobalt-chromium stents.

In-stent restenosis (ISR) remains a significant limitation despite the considerable previous clinical and investigative emphasis on the problem. Complications arising from the interaction of stent materials with the surrounding vessel wall as well as from the mechanical forces developing after implantation, play an important role in the development of ISR. To investigate the relation between mechanical factors and stent structural integrity, and to identify any structural weakness points on the geometry of commercially available Stainless Steel and Cobalt-Chromium stents, accelerated pulsatile durability tests were carried out in a simulated physiological environment. Potential spatial variations in the mechanical properties on stent struts and their role in the observed premature failures of the stent devices during operation were also examined. Fretting wear and fatigue-induced fractures were found on stent surfaces after exposure to cyclic loading similar to that arising in vivo. Nanoindentation studies performed on various locations along the stent struts have shown that the hardness of specific stent locations significantly increases after mechanical expansion. The increase in hardness was associated with a reduction of the material's ability to dissipate energy in plastic deformations, therefore an increased vulnerability to fracture and fatigue. We conclude that the locations of fatigue fractures in stent struts are controlled not only by the geometrically-driven stress concentrations developing during cyclic loading but also by the local material mechanical changes that are imparted on various parts of the stent during the deployment process.

Stent overlapping and geometric curvature influence the structural integrity and surface characteristics of coronary nitinol stents.

Preliminary studies have revealed that some stents undergo corrosion and fatigue-induced fracture in vivo, with significant release of metallic ions into surrounding tissues. A direct link between corrosion and in-stent restenosis has not been clearly established; nonetheless in vitro studies have shown that relatively high concentrations of heavy metal ions can stimulate both inflammatory and fibrotic reactions, which are the main steps in the process of restenosis. To isolate the mechanical effects from the local biochemical effects, accelerated biomechanical testing was performed on single and overlapping Nickel-Titanium (NiTi) stents subjected to various degrees of curvature. Post testing, stents were evaluated using Scanning Electron Microscopy (SEM) to identify the type of surface alterations. Fretting wear was observed in overlapping cases, in both straight and curved configurations. Stent strut fractures occurred in the presence of geometric curvature. Fretting wear and fatigue fractures observed on stents following mechanical simulation were similar to those from previously reported human stent explants. It has been shown that biomechanical factors such as arterial curvature combined with stent overlapping enhance the incidence and degree of wear and fatigue fracture when compared to single stents in a straight tube configuration.

An extension-distraction injury of the thoracic spine with traumatic partial correction of thoracic kyphosis.

Study Design The study is a case report. Objective The authors aim to report an unusual injury pattern in a patient previously treated for thoracic kyphoscoliosis. Methods A postoperative (computed tomography) CT of a healthy 24-year-old man who underwent posterior instrumentation and fusion for a kyphoscoliosis deformity was compared with a CT performed after a motor vehicle accident (MVA) 1 year later, which resulted in an extension-distraction injury of T8 with no neurologic deficit. Cobb angles of the thoracic sagittal images of both CTs were measured using a digital measuring device and the values were recorded. Results Initial postoperative sagittal CT images demonstrate a 67-degree residual thoracic kyphosis compared with the post-MVA sagittal CT images, which reveal a 54-degree thoracic kyphosis, a 13-degree improvement in sagittal alignment. Conclusion It is unusual for a patient with long posterior instrumentation of the spine to sustain a spinal fracture without breakage of the rods, which were 6-mm nickel-titanium alloy with two crosslinks. Although sustaining plastic deformation, the rods maintained their integrity to the degree that the patient required no subsequent treatment to his spine at 12 months follow-up. It is rare to sustain a vertebral fracture without implant failure, which occurred in this case.

Bone Formation Under the Elevated Sinus Membrane Using Venous Coagulum.

INTRODUCTION: Insufficient bone height is a common obstacle to placing dental implants in the posterior maxilla. Sinus grafts have been shown to be a highly predictable way to increase bone height in the posterior maxilla. This case series illustrates a technique using venous coagulum and simultaneous implant placement under the elevated sinus. Bone formation is demonstrated clinically, radiographically, and histologically. To the best of our knowledge, this is the first report of histomorphometric results and microcomputed tomography (micro-CT) using this technique. CASE SERIES: A total of five sinus elevations with simultaneous placement of two dental implants were performed with venous blood coagulum as the sole filling biomaterial. At the time of uncovering, after 8 to 9 months of healing, biopsies were harvested from the lateral wall of the maxilla. This study illustrates bone formation under five elevated sinuses, with simultaneous placement of dental implants, using venous coagulum as the sole filling material. Results showed significant gains in bone height adjacent to the implant. Micro-CT showed well-structured trabecular bone. Histomorphometry of biopsies showed 38% to 74% vital bone. CONCLUSIONS: This case series illustrates that bone-grafting materials in the subsinus cavity are not required for successful placement of implants. Use of one's own blood as filling material removes any objections to grafting, including religious, ethical, or fear of disease transmission. Venous coagulum is a simple, inexpensive biomaterial, and its systematic use during a sinus lift may be a relevant option, ultimately leading to increased access to implant treatment options for patients.

The failure load of CAD/CAM generated zirconia and glass-ceramic laminate veneers with different preparation designs.

STATEMENT OF PROBLEM: Fracture of feldspathic porcelain laminate veneers represents a significant mode of clinical failure. Therefore, ceramic materials that withstand a higher load to fracture, especially for patients with parafunctional habits, are needed. PURPOSE: The purpose of this study was to examine the correlation of material (zirconia, TZP, glass-ceramic, IEC, and feldspathic porcelain, FP) design (incisal overlapped preparation, IOP, and three-quarter preparation, TQP), and fracture mode to failure load for veneers supported by composite resin abutments. MATERIAL AND METHODS: A typodont tooth prepared with 2 designs (IOP, TQP) and the corresponding 2 definitive dies were used to fabricate the composite resin abutments (30 for IOP and 30 for TQP). Ten veneer specimens for each system (Y-TZP, IEC, and FP), were fabricated for each design. The veneers were cemented, invested, and tested in compression until failure by using a universal testing machine. Significant differences were evaluated by 2-factor ANOVA (α=.05). RESULTS: No statistical mean load difference was noted between the preparation designs for Y-TZP (IOP: 244 ±81 and TQP: 224 ±58 N), IEC (IOP: 306 ±101 and TQP: 263 ±77 N), and FP veneers (IOP: 161 ±93 and TQP: 246 ±45 N). No statistical difference in the mean load was found among the 3 veneer materials for each preparation design except between IEC (306 ±101 N) and FP (161 ±93 N) veneers for TQP. CONCLUSIONS: Preparation design did not influence the failure load of the veneer materials. Zirconia veneers were the least likely to fracture but the most likely to completely debond; feldspathic porcelain veneers exhibited the opposite characteristics.

Evaluation of the optical properties of CAD-CAM generated yttria-stabilized zirconia and glass-ceramic laminate veneers.

STATEMENT OF PROBLEM: When feldspathic porcelain (FP) laminate veneers are used to mask tooth discoloration that extends into the dentin, significant tooth reduction is needed to provide space for the opaque layer and optimize the bonding of the restoration. PURPOSE: The purpose of this study was to investigate the color effect of trial insertion paste (TP), composite resin abutment (CRA), and veneer regions on the optical properties of feldspathic porcelain (FP), yttria-stabilized zirconia (Y-TZP), and IPS e.max CAD HT (IEC) veneers. MATERIAL AND METHODS: A melamine tooth was prepared for a laminate veneer on a model, and a definitive cast was made. The definitive die was scanned by using the TurboDent System (TDS), then 30 CRA were machined and 10 veneers were fabricated for each ceramic material (FP, Y-TZP, IEC). The optical properties of different veneer materials, CRA (A(1), A(2), A(3)) and TP (bleach XL, opaque white, transparent, and yellow) were evaluated in the cervical, body, and incisal regions with a spectrophotometer. Results were analyzed by using 1-way ANOVA (.05). RESULTS: The color difference for all the veneers was affected by TP and CRA colors in different regions. The mean values for the Y-TZP veneer color coordinates (L*: 74 ±0.34, a*: 0.09 ±0.20, and b*: 17.43 ±0.44) were significantly different (P<.001) from those of IEC veneers (L*: 70.15 ±0.23, a*: -0.69 ±0.073, and b*:11.48 ±0.30) and FP veneers (L*: 70.00 ±0.86, a*: - 0.28 ±0.203, and b*: 13.86 ±1.08). There was no difference between IEC for L* and FP. Significant difference was detected (P<.001) in color coordinates among the 3 veneer materials for a* and b*. CONCLUSIONS: The TP color affected the color difference for all veneer materials except the Y-TZP, while there was no effect on the CRA color. The magnitude of color coordinates changed as a function of TP color and veneer material.

Influence of low-temperature environmental exposure on the mechanical properties and structural stability of dental zirconia.

PURPOSE: The effect of dental fabrication procedures of zirconia monolithic restorations and changes in properties during low-temperature exposure in the oral environment is not completely understood. The purpose of this study was to investigate the effect of procedures for fabrication of dental restorations by low-temperature simulation and relative changes of flexural strength, nanoindentation hardness, Young's modulus, surface roughness, and structural stability of yttria-stabilized zirconia. MATERIALS AND METHODS: A total of 64 zirconia specimens were prepared to simulate dental practice. The specimens were divided into the control group and the accelerated aging group. The simulated group followed the same procedure as the control group except for the aging treatment. Atomic force microscopy was used to measure surface roughness. The degree of tetragonal-to-monoclinic transformation was determined using X-ray diffraction. Nanoindentation hardness and modulus measurements were carried out on the surface of the zirconia specimens using a nanoindenter XP/G200 system. The yttria levels for nonaged and aged specimens were measured using energy dispersive spectroscopy. Flexural strength was determined using the piston-on-three-ball test. The t-test was used to determine statistical significance. RESULTS: Means and standard deviations were calculated using all observations for each condition and evaluated using a group t-test (p < 0.05). The LTD treatment resulted in increased surface roughness (from 12.23 nm to 21.56 nm for Ra and 15.06 nm to 27.45 nm for RMS) and monoclinic phase fractions (from 2% to 21%), with a concomitant decrease in hardness (from 16.56 GPa to 15.14 GPa) and modulus (from 275.68 GPa to 256.56 GPa). Yttria content (from 4.43% to 4.46%) and flexural strength (from 586 MPa to 578 MPa) were not significantly altered, supporting longer term in vivo function without biomechanical fracture. CONCLUSION: The LTD treatment induced the tetragonal-to-monoclinic transformation with surface roughening in zirconia prepared using dental procedures.

2011 panel on developing a biomaterials curriculum.

This article provides the transcript for the Panel on Developing a Biomaterials Curriculum held at the 2011 annual meeting of the Society for Biomaterials in Orlando, FL. The panelists were Thomas R. Harris of Vanderbilt University, Jack Lemons of the University of Alabama, Birmingham, Antonios G. Mikos of Rice University, David A. Puleo on the University of Kentucky, Frederick J. Schoen of Harvard Medical School, and Johnna S. Temenoff of Georgia Tech/Emory. The panelists, each an expert in engineering education and textbook author, presented their perspectives on key issues of developing undergraduate and graduate curricula that contain a biomaterials focus. The presentations were followed by a lively and informative discussion with the audience. A redacted portion of this discussion is included.

The role of vascular calcification in inducing fatigue and fracture of coronary stents.

Traditional approaches for in-vitro pulsatile and fatigue testing of endovascular stents do not take into consideration the pathologies of the stented vessel and their associated biomechanical effects. One important pathology is calcification, which may be capable of inducing changes in the vessel wall leading to inhomogeneous distribution of stresses combined with wall motion during the cardiac cycle. These local property changes in the region adjacent to stents could directly influence in-vivo stent performance. Seven cases containing a total of 18 stents were obtained from autopsy. Radiographs were evaluated and vessels were sectioned for histology and stent topographical analysis. Stents were retrieved by chemical removal of surrounding tissue and surfaces were evaluated using 3D digital optical and scanning electron microscopy for biomechanical abrasion and fracture features. Pathologic complications such as restenosis and thrombus formation were assessed from histological sections. Direct evidence of fracture was found in 6 of the 7 cases (in 12 out of 18 stents; 9 drug eluting and 3 bare metal). The degree of stent alterations was variable, where separation of segments due to fracture occurred mostly in drug-eluting stents. All fracture surfaces were representative of a high cycle fatigue mechanism. These fractures occurred in complex lesions involving the presence of diffuse calcification alone, or in combination with vessel angulations and multiple overlapping stents. Morphologic analysis of tissue at or near some fracture sites showed evidence of thrombus formation and/or neointimal tissue growth.

In-vivo corrosion and local release of metallic ions from vascular stents into surrounding tissue.

OBJECTIVES: To evaluate retrieved bare metal vascular stents and surrounding tissue. BACKGROUND: Limited information is available regarding the condition of stent surfaces and their interaction with vascular tissue following implantation. Corrosion of stents presents two main risks: release of metallic ions into tissue and deterioration of the mechanical properties of stents which may contribute to fracture. Release of heavy metal ions could alter the local tissue environment leading to up-regulation of inflammatory mediators and promote in-stent restenosis. METHODS: Nineteen cases were collected from autopsy, heart explants for transplant, and vascular surgery (23 vessels containing 33 bare metal stents). A method was developed for optimal tissue dissolution and separation of the stent/tissue components without inducing stent corrosion. When available, chemical analysis was performed to assess metallic content in both the control and dissolved tissue solutions. Electron microscopy and digital optical microscopy imaging were used to evaluate stents. RESULTS: Twelve of the 33 stents showed varying degrees of corrosion. Metallic levels in the tissue surrounding the corroded stents were significantly higher (0.5-3.0 mcg/cm² stent) than in control solutions (0-0.30 mcg/cm² stent) and in tissue surrounding stents that did not undergo corrosion (0- 0.20 mcg/cm² stent). CONCLUSIONS: Corrosion of some retrieved stents is described which leads to transfer of heavy metal ions into surrounding tissue. The contribution of this metallic ion release to the mechanisms of in-stent restenosis as well as its effect on the mechanical properties of stents is unknown and requires further investigation.

Clinical device-related article surface characterization of explanted endovascular stents: evidence of in vivo corrosion.

Limited information exists regarding the in vivo stability of endovascular stents. Nine excised human vascular segments with implanted stents (n = 16) manufactured from stainless steel, nickel-titanium, tantalum, and cobalt-based alloys were analyzed. The stent/tissue components were separated using an established tissue dissolution protocol and control and explanted stents were evaluated by digital optical and electron microscopy. Metallic content in surrounding tissues was measured by mass spectroscopy. Surface alterations, consistent with corrosion mediated by electrochemical and mechanical factors, were observed in 9 of the 16 explanted stents and were absent from control stents. Tissue dissolved from around corroded stents corresponded with a higher metallic content. The effect of these changes in the microtopography of stents on their mechanical properties (fatigue strength and fracture limit) in addition to the potential for released metallic debris contributing to the biological mechanisms of in-stent restenosis supports the need for further investigations.

Retrieval and analysis of explanted and in situ implants including bone grafts.

This article briefly explains the process of, and provides examples from, dental surgical implant device retrieval and analysis. Study results of three areas where unique and new information has been or is being published within professional journals are summarized. An analysis of past and current activities strongly supports opportunities for more in-depth investigations of explanted and postmortem-type specimens. It seems that these types of protocols will be supportive of more fully investigating the clinical applications for successful and unsuccessful outcomes of evolving tissue-engineered medical products as alternatives to some types of synthetic-origin implant devices.

Reporting and notification of adverse events in orthopaedics.

Surgeons should know how to alert the US FDA when an adverse event occurs with a device that has been approved by the FDA. Documentation of such events is critically important to help identify trends concerning a particular device, thereby helping surgeons and other health care professionals avoid similar events. The FDA created the MedWatch program to aid health care professionals in reporting adverse events. Orthopaedic surgeons can use the program to get up-to-date alerts and help protect their patients.