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Lipid concentration profile across the wall of pseudoatherosclerotic synthetic arterial prostheses using FTIR microspectroscopy.

FTIR microscopy is a versatile technique successfully used to probe the subcellular chemical composition of atherosclerostic arterial walls. To design new vascular substitutes that resist lipid uptake (the major cause of the phenomenon referred to as atherosclerosis-like), identifying and understanding lipid distribution within the pseudoatherosclerosed arterial prostheses is of prime importance. Until now, the amount of lipids present within arterial prostheses that had been explanted from either animals (during in vivo trials) or humans (after the failure of vascular grafts) or had been submitted to in vitro investigations could only be measured through the use of histological techniques or radioactive labeling methods. We present here a novel method to quantitatively measure the lipid concentration profile within the wall of arterial prostheses by means of Fourier transform infrared microspectroscopy. Essentially, prostheses are fixed in a 1% osmium tetraoxide aqueous solution under vacuum and radially cut with a 5-micron thickness with a microtome. The sections are then placed onto BaF2 windows and observed with a microscope attached to a FTIR spectrometer with a 30 microns x 50 microns sampling area. The lipid concentration profile is obtained by scanning the prosthesis wall from the inner to the outer surface and reporting the corresponding integrated absorbance between 2700 and 3100 cm(-1) against a calibration curve. The application of this technique constitutes the first quantitative measurement of the concentration of biological molecules within the wall of artificial arterial substitute.

Blood Vessel Prosthesis↗

An in vivo comparative study of the e-polytetrafluoroethylene vascular prostheses: Vitaflon and Gore-Tex.

A comparative study was performed in order to validate new Russian e-PTFE vascular prostheses Vitaflon (St. Petersburg, Russia). The Gore-Tex prostheses were chosen as a referential model. The prostheses were implanted in the venous and arterial positions in 13 dog experiments. After the implantation time was over a comprehensive histological and histochemical examination of excized specimens was performed. It was demonstrated that there is no difference in healing and functional properties between the two studied prostheses.

Journal Article↗

Three dimensional measurement of the surface topography of ceramic and metallic orthopaedic joint prostheses.

The comprehensive study of surface topography of the orthopaedic joint prostheses has become very important for analysis of the wear mechanism and the performance life of the joint replacement systems. The aim of the study to investigate "best" methods for the three-dimensional (3D) surface metrology of orthopaedic joint prostheses. Characterization techniques for the identification and evaluation of the functional features of the bearing surface topographies has been provided in previous work. This paper concentrates on addressing issues of measurement and application techniques for assessment of the 3D surface topography of the joint replacement systems by using contacting stylus instruments, atomic force microscopes (AFM), and non-contacting measurement supported by focus detection instruments and phase-shifting interferometers. The techniques are discussed according to different analysis requirements of the orthopaedic joint prostheses. This work also discusses the performances of the instruments in terms of the measurement of femoral heads. Finally, recommendations for acceptable measurement techniques and application for analyzing surface topography of orthopaedic joint prostheses are summarized.

Journal Article↗

Wear of surface engineered metal-on-metal hip prostheses.

The wear of existing metal-on-metal (MOM) hip prostheses (1 mm3/million cycles) is much lower than the more widely used polyethylene-on-metal bearings (30-100 mm3/million cycles). However, there remain some potential concerns about the toxicity of metal wear particles and elevated metal ion levels, both locally and systemically in the human body. The aim of this study was to investigate the wear, wear debris and ion release of fully coated surface engineered MOM bearings for hip prostheses. Using a physiological anatomical hip joint simulator, five different bearing systems involving three thick (8-12 microm) coatings, TiN, CrN and CrCN, and one thin (2 microm) coating diamond like carbon (DLC) were evaluated and compared to a clinically used MOM cobalt chrome alloy bearing couple. The overall wear rates of the surface engineered prostheses were at least 18-fold lower than the traditional MOM prostheses after 2 million cycles and 36-fold lower after 5 million cycles. Consequently, the volume of wear debris and the ion levels in the lubricants were substantially lower. These parameters were also much lower than in half coated (femoral heads only) systems that have been reported previously. The extremely low volume of wear debris and concentration of metal ions released by these surface engineered systems, especially with CrN and CrCN coatings, have considerable potential for the clinical application of this technology.

Biomedical Engineering↗

Healing characteristics of small-calibre vascular prostheses coated with plasmin-treated fibrin--an experimental study.

BACKGROUND: The autogenous vein represents the graft material of choice in crural and pedal bypass surgery. Because of the numerous problems concerning the graft harvesting and the quality of autogenous vein material an equally good allogenous graft is urgently needed. Up to the present times no such graft material has been able to achieve the success of vein grafts. METHODS: We investigated the knitted polyester prosthesis Terumo PF-V (Terumo Comp., Japan), diameter 5 mm with outer reinforce, which is characterized by a new coating of plasmin-treated fibrin. Grafts were implanted as bypass into the ligated carotid (n = 10) and femoral arteries (n = 10) of 10 dogs (beagles). As a control 5 mm-ePTFE-prostheses (Impra Carboflo) were implanted simultaneously on the contralateral side. RESULTS: After 6 months, seven of 20 PF-V-grafts and 8 of 20 PTFE-grafts were patent. All prostheses presented with good macroscopic healing characteristics. In the patent grafts, angiography showed no substantial stenoses. The histological examination of the material was performed using light microscopy, transmission polarising microscopy, scanning electron microscopy, and transmission electron microscopy. Both types of prostheses showed the typical pattern of graft healing by migration of mesenchymal cells through the prosthesis, formation of capillaries, and growing of a neointima with endothelium-like cells. All failed bypass grafts presented with an occluding proliferation from the arterial wall into the anastomotic region. CONCLUSIONS: Using clinically or histologically evaluation, neither graft demonstrated superiority over the other. The results indicate that the coating plays only a minor role for graft healing if any. For proper graft function, the arterial wall proliferation at the anastomotic region, which is not dependent on the type of prosthesis, appears to be most important. The overall results concerning both types of prostheses were disappointing.

Animals↗

Ten-year survival rates of fixed prostheses on four or six implants ad modum Brånemark in full edentulism.

A series of 156 consecutive fully edentulous patients were rehabilitated by means of fixed prostheses on either 4 or 6 screw-shaped titanium implants. This retrospective study calculated survival rates for both prostheses and individual implants. Only patients with a 10-year follow-up were considered. The implant lengths were 10 (90%) or 7 mm. They were all inserted after pretapping. In the mandible 13 and 59 prostheses were installed on respectively 4 and 6 implants. In the upper jaw the respective numbers were 14 and 70. Both groups (4 versus 6 implants) were age- and gender-matched. A reduced jaw bone volume was the major reason for limiting the number of implants to 4. Although a tendency existed for an increased failure rate in patients with only 4 implants, the survival rate for both individual implants and prostheses was the same in both groups at the end of the 10-year observation period. The present tendency of some clinicians to install as many implants as possible in full edentulism should be seriously questioned.

Adult↗

A prospective 15-year follow-up study of mandibular fixed prostheses supported by osseointegrated implants. Clinical results and marginal bone loss.

In this prospective study 47 edentulous patients were treated with mandibular fixed prostheses supported by osseointegrated Brånemark implants and followed for 12 to 15 years. Three (1%) of the 273 inserted implants were lost, two before and one six years after placement of the fixed prosthesis. The cumulative success rate (CSR) of the implants was 98.9% both after 10 and 15 years. None of the fixed prostheses was lost and at the last follow-up, all patients had stable fixed prostheses in function (CSR 100%). The marginal bone loss around the implants was small, on average 0.5 mm during the first post surgical year and thereafter about 0.05 mm annually. More bone was lost around the anterior implants than around the most posterior ones. Smoking and poor oral hygiene had significant influence on bone loss, while occlusal loading factors such as maximal bite force, tooth clenching and length of cantilevers were of minor importance. It is concluded that the long-term results of the mandibular implant treatment were extremely successful, regarding both the fixed prostheses and implant stability. Bone resorption around the implants, albeit limited, was influenced by several factors, smoking and oral hygiene appeared to be most important.

Adult↗

Food selection and perceptions of chewing ability following provision of implant and conventional prostheses in complete denture wearers.

The loss of natural teeth compromises chewing efficiency, and edentulous patients often have a diet that is deficient in fibre and vitamins. Prostheses that are retained on implants offer the possibility of overcoming some of the limitations of conventional dentures in terms of chewing efficiency. The aim of this study was to test the hypothesis that improvement in satisfaction with oral prostheses would result in improved food selection in edentulous patients. This prospective study involved three groups, namely (i) subjects who requested and received implants to stabilise a complete fixed or removable prosthesis (IG, n = 26), (ii) edentulous subjects who requested implant prostheses, but received conventional dentures (CDG1, n = 22), and (iii) edentulous subjects who requested and received conventional dentures (CDG2, n = 35). Data were collected using validated questionnaires pre- and postoperatively. Prior to treatment, all subjects were asked whether they ate a variety of hard and soft foods, to indicate the degree of difficulty they experienced when chewing these foods, and to rate their satisfaction with various aspects of their maxillary and mandibular complete dentures. Following the completion of treatment, subjects completed the questionnaires again. Pre- and postoperative data were compared. Subjects who received implant prostheses reported significant improvement in chewing hard and soft foods. CDG2 subjects also reported improvement, but CDG1 subjects reported no change or even deterioration following treatment. Despite reported improvement in satisfaction with comfort and ability to chew food, 30-50% of IG and CDG2 subjects still avoided eating foods such as carrot and apple. This suggests that, in the absence of tailored dietary advice, apparently successful prosthetic rehabilitation does not necessarily result in a satisfactory diet.

Aged↗

Succinylated collagen crosslinked by thermal treatment for coating vascular prostheses.

Vascular prostheses coated with collagen carefully prepared to avoid contamination were tested to see if it could induce endothelial cell lining throughout the graft surface in a natural way. The collagen fibers were succinylated. Hydrogel produced with the succinylated collagen was used for the sealant to reduce the amount of solid substance. To avoid contamination and the side effects of chemical reagents, the collagen thermally crosslinked under sterile conditions. A suspension of the collagen fibers was enmeshed in the interstices of Dacron fibers of fabric prostheses, which were then thermally crosslinked at 130 degrees C for 20 h. The prostheses were porous when the collagen fiber network was dry. Under wet conditions, however, the water permeability of the grafts was reduced to 0.1 ml/min from the 1,250 ml/min of the original prostheses. Three weeks after implantation in the abdominal aortas of dogs, 81.2 +/- 11% of the luminal surface was macroscopically thrombus free, and 56 +/- 14% was endothelialized. More than 95% of the coated collagen had been absorbed. Numerous fibroblasts had migrated into the graft walls, and capillary blood vessels had infiltrated the inside of the graft walls without foreign body reaction. In the controls, thrombus free areas averaged 9.0 +/- 5%, and endothelialized areas averaged 5.2 +/- 4%. Many giant cells, plasma cells, and lymphocytes had migrated into the graft walls, but no fibroblasts. These results suggest that rapid endothelialization is possible when clean collagen is used.

Animals↗

Biomechanical analysis of two ulnar head prostheses.

The biomechanical effectiveness of 2 ulnar head prostheses was evaluated in 5 fresh-frozen cadaver arms. By using electromagnetic sensors, the amount of forearm rotation, diastasis, and dorsal/palmar subluxation of the radius at the level of the sigmoid notch was measured with the forearm in neutral rotation, pronation, and supination with and without dorsal/palmar loading. Testing was done in the intact specimens and after insertion of 2 types of ulnar head prostheses. Dynamic forearm rotation was also achieved by applying loads in the line of action of the appropriate pronator or supinator muscles to obtain a centroidal path of the radius relative to the ulna. Overall after ulnar head replacement forearm rotation lessened in pronation, diastasis decreased in most forearm positions, and subluxation increased in supination compared with the intact specimen. Despite these changes, both prostheses maintained near-normal biomechanics of the distal radioulnar joint when compared with the irregular behavior occurring after distal ulna resection. Therefore these prostheses are suggested for restoration of distal radioulnar joint function.

Biomechanical Phenomena↗

A comparison of ex vivo and in vitro Sutter metacarpophalangeal prostheses.

Forty-one Sutter metacarpophalangeal prostheses were implanted into 11 hands of nine patients. Twelve of these prostheses were revised from three patients after a mean period of 42 months. Of the 12 prostheses, 11 showed fracture at the junction of the distal stem and the central hinge region. Two Sutter metacarpophalangeal prostheses were tested on a single station finger simulator and both failed due to fracture at the junction of the hinge and the distal stem.

Arthritis, Rheumatoid↗

Fit of implant-supported fixed prostheses fabricated on master casts made from a dental stone and a dental plaster.

STATEMENT OF PROBLEM: The impression and cast on which an implant-supported fixed prosthesis is fabricated must accurately reproduce the intraoral relations. PURPOSE: The fit of fixed prostheses fabricated on master casts poured in a conventional die stone and in an ultra-low-expansion plaster was investigated in vitro. MATERIAL AND METHODS: An impression was made of patient replicas with inter-implant abutment distances of 50 and 35 mm. Ten master casts were poured in a conventional die stone (Velmix, Kerr) and 10 in an ultra-low-expansion plaster (Gnathostone, Zeus). A simulated plaster fixed prosthesis was fabricated on each master cast and then returned in a random order to the appropriate patient replica. The fixed prostheses were screwed into place on one abutment with a torque of 10 Ncm. Vertical discrepancies were measured at the other abutment by an operator blinded to the cast on which the fixed prosthesis was fabricated. A 2-way analysis of variance was performed for distance and materials, and significant differences were identified with regression analysis. RESULTS: For the 50-mm inter-abutment distance, die stone master casts produced a mean vertical discrepancy of 80 microm (SD 32.50 microm). Plaster master casts produced a mean vertical discrepancy of 42.8 microm (SD 12.17 microm). The means were significantly different (P=.01). For the 35-mm inter-abutment distance, the mean vertical discrepancy produced from the die stone and plaster master casts was 84.33 microm (SD 49.9 microm) and 0 microm (SD 0), respectively. The means were significantly different (P<.001). A significant difference was found between the mean vertical seating discrepancies of fixed prostheses produced from plaster casts with inter-abutment differences of 50 mm and plaster casts with inter-abutment distances of 35 mm (P=.003). No significant differences were found between mean vertical seating discrepancies for fixed prostheses fabricated on die stone casts. CONCLUSION: In this in vitro study, master casts poured in an ultra-low-expansion plaster limited to a maximum inter-abutment dimension of 35 mm were more accurate than casts with 50-mm inter-abutment spans or those poured in a conventional die stone.

Analysis of Variance↗

Prospective randomized comparison of CarboMedics and St Jude Medical bileaflet mechanical heart valve prostheses: an interim report.

OBJECTIVE: This is a midterm report of a study comparing the clinical performance of CarboMedics and St Jude Medical heart valve prostheses through a projected 10-year period. METHODS: Between 1992 and 1996, a total of 485 patients undergoing mechanical valve replacement were prospectively randomly assigned to receive either CarboMedics (n = 234) or St Jude Medical (n = 251) prostheses for aortic (n = 288), mitral (n = 160), or double (n = 37) valve replacements and were followed up annually. RESULTS: Baseline and operative characteristics were similar between the two groups with respect to major demographic characteristics, preoperative clinical status, and operative data. Mean follow-up was 50 +/- 22 months for the CarboMedics group (97% complete) and 47 +/- 20 months for the St Jude Medical group (96% complete), yielding a total of 1959 patient-years. The 30-day mortality, and 5-year actuarial survival, and linearized survival were 6.0%, 82.4% +/- 2.6%, and 4.3% per patient-year in the CarboMedics group and 4.4%, 79.9% +/- 2.8%, and 4.7% per patient-year in the St Jude Medical group (log-rank P =.7). Freedom at 5 years from valve-related mortality, major thromboembolism, hemorrhage, and other nonstructural valve dysfunction was, respectively, 96.7% +/- 1.4% (0.7% per patient-year), 90.9% +/- 2.1% (2.2% per patient-year), 87.3% +/- 2.5% (3.6% per patient-year), and 96.1% +/- 1.4% (0.7% per patient-year) in the CarboMedics group and 95.9% +/- 1.5% (1.0% per patient-year), 92.5% +/- 1.8% (2.0% per patient-year), 82.6% +/- 2.8% (4.3% per patient-year), and 96.0% +/- 1.3% (0.6% per patient-year) in the St Jude Medical group, with no overall intergroup differences. No statistically significant intergroup differences in international normalized ratio values were detected during the study period. CONCLUSIONS: This study shows no significant differences in the early and midterm clinical outcomes between patients who received CarboMedics valve prostheses and those who received St Jude Medical mechanical prostheses. Choices with respect to valve type can be based on considerations other than patient outcome.

Adolescent↗

Compound polyglactin 910/polypropylene small vessel prostheses.

This study evaluated morphologic and functional characteristics of tissue reactions to compound prostheses of 69% absorbable polyglactin 910 (PG910) and 31% nonabsorbable polypropylene in the rabbit. Forty-two woven PG910/polypropylene prostheses (24 X 4 mm internal diameter) implanted into rabbit infrarenal aortas were harvested after 2 weeks to 12 months. Each explant was photographed and sectioned for light microscopy and transmission and scanning electron microscopy. Randomly selected explants underwent either compliance and bursting strength measurements or assays of production of prostacyclin and thromboxane metabolites by luminal surfaces of both regenerated conduits and normal control aortas in response to administered sodium arachidonate. Results showed 100% patency with no aneurysms and 2% stenoses (1 of 42 prostheses). Confluent endothelial-like cellular luminal surfaces covering oriented smooth muscle-like myofibroblasts comprised the inner capsules whose thicknesses stabilized at 1 to 2 months. Only residual polypropylene remained in the prostheses after 2 months. Compliance studies reflected a 0.65 mm (14%) change over a pressure range of 0 to 160 mm Hg. All regenerated prosthesis-tissue complexes had bursting strengths greater than the proximal perianastomotic native aortas, which burst between 600 and 2000 mm Hg. At 1 month the rate of production of 6-keto-PGF1 alpha per square millimeter of surface area of experimental segments was normal. Production of 6-keto-PGF1 alpha by experimental segments at 3 months had increased fourfold whereas thromboxane B2 (TxB2) production remained unchanged. The 6-keto-PGF1 alpha/TxB2 ratio increased from 1 to 4 months. This study demonstrates clinically efficacious morphologic, mechanical, and biochemical characteristics of PG910/polypropylene-elicited vascular prosthesis-tissue complexes.

6-Ketoprostaglandin F1 alpha↗

Polyglactin 910/polydioxanone bicomponent totally resorbable vascular prostheses.

Previous studies from our laboratory have shown that bioresorbable vascular prostheses woven from lactide-glycolide copolymers and implanted into arteries of several animal models become replaced by cellular tissues; the rate of replacement parallels the kinetics of prosthetic resorption. This study evaluates the efficacy of bicomponent resorbable prostheses as a method of augmenting resistance to dilatation during the resorption period of the more rapidly resorbed component. Bicomponent prostheses (n = 37) were woven from compound yarns containing 74% polyglactin 910 (PG910) and 26% polydioxanone (PDS) and were interposed into adult white New Zealand rabbit infrarenal aortas. Resultant prosthesis-tissue complexes were harvested after 2 weeks to 12 months. Specimens were photographed and sectioned for light, scanning, and transmission electron microscopy. Randomly selected fresh explants at 1 and 3 months and control aortic segments from the same rabbits were simultaneously perfused with culture media (37 degrees C, 100/80 mm Hg, 60 ml/min) and perfusates assayed by means of tritiated radioimmunoassay techniques for the stable prostacyclin metabolite 6-keto-PGF1 alpha before and after the addition of sodium arachidonate (10 micrograms/ml) to the media. Results showed 100% patency, no aneurysms, and stenosis in 1 of 37 prostheses (3%). PG910 was totally resorbed by 2 months and PDS by 6 months. By 1 month inner capsule thickness was 303 +/- 30 microns. In contrast to previous reports this was significantly thicker than that within 100% PDS (230 +/- 40 microns) and significantly less thick than in 100% PG910 (530 +/- 62 microns). Inner capsules in all three groups stabilized at similar thicknesses (417 to 502 microns).(ABSTRACT TRUNCATED AT 250 WORDS)

6-Ketoprostaglandin F1 alpha↗

Comparative in vivo study on the healing qualities of four different presealed vascular prostheses.

PURPOSE: The purpose of this article is to assess the healing qualities of presealed knitted polyester prostheses. METHODS: Thoracic aortic replacement was performed with grafts with four different coating materials-collagen (CP), albumin (AP), and two with gelatin (GP1/GP2)-in four groups of 15 pigs each. Two weeks, 6 weeks, and 6 months after operation, five pigs of each group were killed. Healing quality was assessed by morphometric analysis of the remaining coating, the extent of tissue ingrowth, and the thickness of the inner layer. RESULTS: The sealant was rapidly absorbed in all prostheses except for the AP (remaining coating at 2 weeks: GP1 22.1%, GP2 34.7%, and CP 68.0% vs AP 97.1% [p < 0.05]), remaining coating at 6 weeks: GP1/GP2 0% and CP 2.5% vs AP 76.7% (p < .01). At 6 months, remaining coating was only detectable in AP (21.5%). At 2 weeks the extent of tissue ingrowth ranged from 65.7% in GP1 and 75.3% in CP to 80% in GP2 versus 8.9% in AP (p < 0.05). There was a slow increase of tissue ingrowth until the sixth postoperative week (GP1 74.4%, GP2 85.0%, and CP 91.3% versus AP 19.6% [p < 0.01]). Thickness of the internal layer varied from 0.11 to 0.21 mm at 2 weeks in all grafts studied and from 1.02 mm (AP) and 1.28 mm (GP2) to 1.39 mm (GP1), versus 0.41 mm in the CP (p < 0.01) after 6 months of implantation. CONCLUSIONS: The type of coating significantly influences the healing properties of knitted polyester prostheses. When used for thoracic aortic replacement in pigs, AP coating clearly results in inferior healing compared with GP1/GP2 or CP impregnation, with digestion of the coating material and tissue ingrowth used as parameters. The thinnest internal layer was found in the CP prostheses, reflecting superior healing properties of this coating in the model studied.

Absorption↗

Stemmed femoral knee prostheses: effects of prosthetic design and fixation on bone loss.

Although the revision rates for modern knee prostheses have decreased drastically, the total number of revisions a year is increasing because many more primary knee replacements are being done. At the time of revision, bone loss is common, which compromises prosthetic stability. To improve stability, intramedullary stems are often used. The aim of this study was to estimate the effects of a stem, its diameter and the interface bonding conditions on patterns of the bone remodeling in the distal femur. We created finite element models of the distal half of a femur in which 4 types of knee prostheses were placed. The bone remodeling process was simulated using a strain-adaptive bone remodeling theory. The amount of such remodeling was determined by calculating the changes in bone mineral density in 9 regions of interest from simulated DEXA scans. The computer simulation model showed that revision prostheses tend to cause more bone resorption than primary ones, especially in the most distal regions. Predicted long-term bone loss due to a revision prosthesis with a thin stem equalled that around a prosthesis with an intercondylar box. However, strong regional differences were found--the stemmed prostheses having more bone loss in the most distal areas and some bone gain in the more proximal ones. A prosthesis with a thick stem led to an increase in bone loss. When the prosthesis-cement interface was bonded, more bone loss was predicted than with an unbonded interface. These results suggest that a stem which increases stability initially may reduce stability in the long term. This is due to an increase in stress shielding and bone resorption.

Bone Remodeling↗