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Heat generated by knee prostheses.

Temperature sensors were placed in 50 knees in 25 patients who had one or both joints replaced. Temperature recordings were made before walking, after walking, and after cycling. The heat generated in healthy, arthritic, and replaced knees was measured. The knee replacements were done using eight different prostheses. A rotating hinge knee prosthesis generated a temperature increase of 7 degrees C in 20 minutes and 9 degrees C in 40 minutes. An unconstrained ceramic femoral prosthesis articulating with a polyethylene tibial prosthesis generated a temperature increase of 4 degrees C compared with a healthy resting knee. The other designs using a cobalt-chrome alloy and high-density polyethylene had temperature increases of 5 degrees-7 degrees C with exercise. Frictional heat generated in a prosthetic knee is not immediately dissipated and may result in wear, creep, and other degenerative processes in the high-density polyethylene. Extended periods of elevated temperature in joints may inhibit cell growth and perhaps contribute to adverse performance via bone resorption or component loosening. Prosthetic knees generate more heat with activity than healthy or arthritic knees. More-constrained knee prostheses generate more heat than less-constrained prostheses. A knee with a ceramic femoral component generates less heat than a knee with the same design using a cobalt-chromium alloy.

Aged↗

Novel "biomechanical" polymeric valve prostheses with special design for aortic and mitral position: a future option for pediatric patients?

In children, systemic heart valve replacement with bioprostheses is associated with accelerated valve degeneration, and mechanical prostheses require permanent anticoagulation. Novel "biomechanical" polymeric valve prostheses ("bio" = flexible, "mechanical" = synthetic), solely made of polycarbonate urethane (PCU), were tested in vitro and in a growing animal (calf) model with the aim of improved durability without permanent anticoagulation. The trileaflet aortic prosthesis has diminished pressure loss and reduced stress and strain peaks. The asymmetric bileaflet mitral valve mimics natural nonaxial inflow. The valves underwent long-term in vitro testing and in vivo testing in growing calves for 20 weeks [mitral (7), aortic (7)] with comparison to different commercial bioprostheses [mitral (7), aortic (2)]. In vitro durability of PCU valves was proved up to 20 years. Survival of PCU valves versus bioprostheses was 7 versus 2 mitral and 5 versus 0 aortic valves, respectively. Two animals with PCU aortic valves died of pannus overgrowth causing left ventricular outflow tract obstruction. Degeneration and calcification were mild (mitral) and moderate (aortic) in PCU valves but were severe in biological valves. There was no increased thrombogenicity of the PCU valves compared to bioprostheses. The novel polymeric valve prostheses revealed superior durability compared to current bioprostheses in growing animal model without permanent anticoagulation and thus, may be a future option for pediatric patients.

Animals↗

Safety of magnetic resonance imaging of stapes prostheses.

OBJECTIVE: Assess the safety of performing magnetic resonance imaging (MRI) on patients with stapes prostheses. STUDY DESIGN: Survey and animal model. METHODS: A survey regarding implant usage, MRI procedures, and adverse outcomes after MRI in patients previously undergoing stapes procedures. Guinea pigs implanted with ferromagnetic 17 to 4 stainless steel, 316L nonferromagnetic stainless steel, titanium, and fluoroplastic stapes prostheses underwent a MRI in a 4.7 Tesla MR system. RESULTS: : Three adverse outcomes were reported on the clinical survey. One adverse event occurred during an MRI performed on a recalled ferromagnetic prosthesis. The other two adverse events were probably not secondary to MRI exposure. No damage or inflammation was observed in the region of the oval window or vestibule of implanted guinea pigs exposed to a 4.7 Tesla MR system. CONCLUSIONS: The combination of prior studies, the clinical survey, and the absence of histopathologic evidence of damage in the guinea pigs is compelling evidence that MRI for patients with stapes prostheses is safe. Implanting physicians should feel comfortable clearing a patient for a MRI in a 1.5 Tesla or 3.0 Tesla MRI. It is imperative for the physician to qualify the field strength when clearing a patient to undergo a MRI.

Alloys↗

The optimal therapeutic range for oral anticoagulant treatment as suggested by fibrinopeptide A (FpA) levels in patients with heart valve prostheses.

Fibrinopeptide A is a good marker of in vivo thrombin formation. The aim of oral anticoagulants (OA) is to lower in vivo thrombin formation. We therefore assessed FpA levels on several occasions in 38 patients receiving OA for artificial heart valve prostheses and in 20 patients receiving OA for biological heart valve prostheses. The mean FpA level, 1.82 ng ml-1 (SEM 0.14, n = 176), in patients with artificial valves was significantly higher than the mean, 1.02 ng ml-1 (SEM 0.4), obtained in 41 healthy subjects (P = 0.01). FpA mean value for biological valves was 1.41 ng ml-1 (SEM 0.14, n = 76), which was not significantly higher than controls (P = 0.08). A decrease in FpA levels, for both artificial and biological heart valve prostheses, was associated with a parallel increase in the intensity of anticoagulation. When considering FpA values obtained in the optimal therapeutic range for oral anticoagulant treatment, (International Normalized Ratio [INR] between 3 and 4.5), the mean level for artificial valves, 1.87 ng ml-1 (SEM 0.18, n = 102), was significantly higher than the mean value, 1.25 ng ml-1 (SEM 0.16, n = 55), obtained for biological valves. From a biological point of view, this indicates that artificial valves should be kept at a higher intensity of anticoagulation.

Administration, Oral↗

Metal wear in Lillehei-Kaster heart valve prostheses.

Ten Lillehei-Kaster heart valve prostheses, in situ for up to 10 years and recovered at surgery or necropsy, were examined by light and scanning electron microscopy. All showed metal wear on the luminal aspect of their struts. The volume of wear related to the duration a prosthesis had been in situ. The worn metal showed distinct, transverse surface corrugations, which became more obvious with time. Aortic prostheses wore more and faster than mitral ones. One strut usually showed more wear than the other, a change likely due to specific manufacturing methods. It is believed that the pattern of wear is caused by a velocity-controlled stick-slip abrasive wear process, resulting from an interaction between the edge of the moving pyrolytic carbon disc, the struts' titanium surface, and the protein coat covering that surface. None of the patients had prosthesis dysfunction attributable to metal wear. Disc escape seems unlikely considering the degree of wear observed after 10 years. Furthermore, the surface corrugations did not appear to cause disc sticking or other problems. However, clinicians might consider monitoring patients who have borne these prostheses for greater than 10 years.

Aortic Valve↗

Noise level and perception of the closing click after heart valve replacement with St. Jude Medical and Björk Shiley Monostrut prostheses.

The metallic click generated by the closure of mechanical heart valve prostheses may severely bother patients, but generated sound energy and the extent of complaints after implantation are not known. In 62 patients, after valve replacement with St. Jude Medical (SJM) (n = 35) and Björk Shiley Monostrut (BSM) (n = 27) prostheses, sound energy was recorded with a calibrated noise level analyzer at 5, 10, and 100 cm distance from patients and correlated with their complaints. At a distance of 100 cm, the BSM valves produced a significantly higher sound pressure level, 30.5 +/- 5 db(A), compared to the SJM valves, 24.1 +/- 4 db(A) (p = 0.0001). There was no significant difference at shorter distances. After splitting into frequency bands the highest sound pressure levels were observed in the high frequency ranges (8 to 16 kHz) representing the metallic click. BSM valves produced higher sound levels in all frequency ranges at 1 m distance. Seventy-three percent of all patients were aware of the noise generated by the valve; 20% had disturbed sleep; and 26% preferred a less noisy valve type. Twelve of 27 patients with BSM valves wanted less noisy valves, whereas only 4 of 35 patients with SJM valves wished to have a less noisy valve type (Chi-square p = 0.003). In patients who could hear their valve measured, sound level was higher than in patients who could not. In 9 of 27 patients with BSM (33%), versus 3 of 35 with SJM prostheses (9%), the clicking caused sleep disturbances.(ABSTRACT TRUNCATED AT 250 WORDS)

Acoustics↗

Intracellular calcium response and adhesiveness of chick embryonic retinal neurons to photoelectric dye-coupled polyethylene films as prototypes of retinal prostheses.

Photoelectric dyes, which absorb light and convert photon energy to electric potentials, were shown to stimulate retinal neurons in culture. One of these dyes coupled with polyethylene film surface, as a prototype of retinal prostheses, could induce intracellular calcium elevation in chick embryonic retinal tissues. In this study, we used retinal cells from chick embryos in which no photoreceptor outer segments yet developed, and assessed cell adhesiveness and response to the original and modified types of our retinal prostheses. Extruded-blown film of high density polyethylene was used as the original polyethylene film. Polyethylene film surface was modified either by coupling with type 1 collagen or by crystallization from the melt of the original polyethylene film. A photoelectric dye, 2-[2-[4-(dibutylamino)phenyl]ethenyl]-3-carboxymethylbenzothiazolium bromide, was coupled to these different types of polyethylene films through amide linkage. Retinal cells from chick embryos at the 12-day embryonic stage were cultured on the surface of dye-coupled films. The response of retinal cells to the dye-coupled films was observed by calcium imaging. Cell types, either neurons or glial cells, were detected by immunocytochemical staining and also observed by scanning electron microscopy (SEM). Intracellular calcium elevation was observed in cells, including both neurons and glial cells, on the surface of the original dye-coupled film, collagen-coated dye-coupled film, and dye-coupled recrystallized film, in contrast with no response of cells cultured on the dye-uncoupled plain film. Retinal neurons grew upon colonies of glial cells settling on the surface of all different types of the films. The number of retinal neurons on the collagen-coated dye-coupled film and dye-coupled recrystallized film was significantly larger than the number of neurons on the dye-uncoupled plain film (P = 0.0004, analysis of variance; P < 0.05, Tukey-Kramer test). With SEM, Muller cell-like large cells covered the original dye-coupled film and collagen-coated dye-coupled film, while neuron-like small cells settled directly on the dye-coupled recrystallized film and also formed large colonies on Muller-like cells. Retinal neurons and glial cells were cultured directly on the different types of dye-coupled polyethylene films. Photoelectric dye-coupled polyethylene films could be used as prototypes of retinal prostheses.

Aniline Compounds↗

Adding retentive features in the rebonding of cast metal resin-bonded prostheses.

Many methods have been used to improve retention in resin-retained fixed prostheses, such as electrolytic etching of the retainer, the labial wrap design, proximal grooves, cast pin retention, and the use of improved adhesive resins such as Panavia EX (Kuraray Co, Osaka, Japan). Insufficient retentive features often lead to debonding of resin-retained fixed prostheses. Debonded prostheses may occasionally be recemented and successfully retained by the addition of retentive features to the prosthesis and abutment teeth. When recementing a debonded prosthesis with questionable retention, additional retention may be added to the retentive wings of the prosthesis by using a Rochette retentive hole in combination with pin retention or enamel/dentinal slots in the abutment teeth.

Dental Pins↗

Finite element analysis on dental implant-supported prostheses without passive fit.

PURPOSE: The purpose of this study is to use finite element analysis to investigate the effect of misfit prostheses, cantilever prostheses, and various occlusal forces on the stress distribution in the prostheses, implant components, and surrounding bone. MATERIALS AND METHODS: Two 3-dimensional finite element models were constructed: (1) a 2-implant-supported, 2-unit fixed partial denture and (2) a 2-implant-supported, 2-unit fixed partial denture with a distal cantilever. Variations of the standard finite element models were made by placing a 111-microm gap between the gold cylinder on either the mesial or distal implant. The effects of load of 100 N were tested on all models. Subsequently, loads of 50 N, 200 N, and 300 N were evaluated on the cantilever model. RESULTS: When the gap was positioned near to the applied force, the stress in both models increased significantly in the implant components and surrounding bone. The stress increase in each component ranged from 8% to 64% in the non-cantilever models and 43% to 85% in the cantilever models. The greatest stress was found in the distal gold screw. The effect of the gap was clearly shown by the pattern of stress distribution in both models. Additionally, the presence of a cantilever and excessive occlusal force amplified the effect of prosthesis misfit. CONCLUSIONS: Prosthesis misfit influenced the pattern and magnitude of stress distribution in the prosthesis, implant components, and surrounding bone, and the presence of the cantilever or greater occlusal force amplified the effect of misfit.

Bite Force↗

Neuromuscular coordination of masticatory muscles in subjects with two types of implant-supported prostheses.

OBJECTIVES: To compare the electromyographic (EMG) characteristics of masticatory muscles in patients with fixed implant-supported prostheses and implant overdentures. MATERIAL AND METHODS: Nineteen subjects aged 45-79 years were examined. Fourteen were edentulous and had been successfully rehabilitated with (a) maxillary and mandibular implant-supported fixed prostheses (seven patients); (b) mandibular implant overdentures and maxillary complete dentures (seven patients). Five control subjects had natural dentition or single/partial (no more than two teeth) tooth or implant fixed dentures. Surface EMG of the masseter and temporal muscles was performed during unilateral gum chewing and during maximum teeth clenching. To reduce biological and instrumental noise, all values were standardized as percentage of a maximum clenching on cotton rolls. RESULTS: During clenching, temporal muscle symmetry was larger in control subjects and fixed implant-supported prosthesis patients than in overdenture patients (analysis of variance, P=0.005). No differences were found in masseter muscle symmetry or in muscular torque. Muscle activities (integrated areas of the EMG potentials over time) were significantly larger in control subjects than in implant-supported prosthesis patients (P=0.014). In both patient groups, a poor neuromuscular coordination during chewing, with altered muscular patterns, and a smaller left-right symmetry than in control subjects were found (P=0.05). No differences in masticatory frequency were found. CONCLUSION: Surface EMG analysis of clenching and chewing showed that fixed implant-supported prostheses and implant overdentures were functionally equivalent. Neuromuscular coordination during chewing was inferior to that found in subjects with natural dentition.

Adaptation, Physiological↗

Long term results of mechanical prostheses for treatment of active infective endocarditis.

OBJECTIVE: To analyse the long term results of mechanical prostheses for treating active infective endocarditis. DESIGN: Prospective cohort study of a consecutive series of patients diagnosed with infective endocarditis and operated on in the active phase of the infection for insertion of a mechanical prosthesis. SETTING: Tertiary referral centre in a metropolitan area. RESULTS: Between 1975 and 1997, 637 cases of infective endocarditis were diagnosed in the centre. Of these, 436 were left sided (with overall mortality of 20.3%). Surgical treatment in the active phase of the infection was needed in 141 patients (72% native, 28% prosthetic infective endocarditis). Mechanical prostheses were used in 131 patients. Operative mortality was 30.5% (40 patients). Ninety one survivors were followed up prospectively for (mean (SD)) 5.4 (4.5) years. Thirteen patients developed prosthetic valve dysfunction. Nine patients suffered reinfection: four of these (4%) were early and five were late. The median time from surgery for late reinfection was 1.4 years. During follow up, 12 patients died. Excluding operative mortality, actuarial survival was 86.6% at five years and 83.7% at 10 years; actuarial survival free from death, reoperation, and reinfection was 73.1% at five years and 59.8% at 10 years. CONCLUSIONS: In patients surviving acute infective endocarditis and receiving mechanical prostheses, the rate of early reinfection compares well with reported results of homografts. In addition, prosthesis dysfunction rate is low and long term survival is good. These data should prove useful for comparison with long term studies, when available, using other types of valve surgery in active infective endocarditis.

Acute Disease↗

Results after mitral valve replacement with cloth-covered Starr-Edwards prostheses (models 6300, 6310/6320, and 6400).

The actuarial survival and thromboembolic rates for the three types of cloth-covered Starr-Edwards mitral prostheses, models 6300, 6310/6320, and 6400 followed 6, 5, and 2 years, respectively, were not significantly different throughout the years they were followed. The combined cumulative survival and thromboembolic proportion at 5 years for these prostheses were 71 and 66 per cent, respectively. The thromboembolic rates were not different in the following two groups: (a) 238 patients receiving anticoagulants, and (b) 52 patients who had discontinued or who were not receiving anticoagulants. Four patients thrombosed their mitral prostheses. Another 8 per cent had class 3 symptoms after operation, which were attributed to myopathic or restrictive left ventricular dysfunction or other valvular disease.

Adult↗

Haemodynamic performance of aortic pericardial bioprostheses and bileaflet prostheses at rest and during exercise: implications for the surgical management of patients with small aortic roots.

OBJECTIVE: To determine the haemodynamic behaviour, at rest and during exercise, of aortic valve pericardial bioprostheses and different sizes of bileaflet prosthesis. DESIGN: Observational study. SETTING: Tertiary medical centre. PATIENTS AND INTERVENTIONS: 74 patients (33 women, 41 men; mean age 64 years) in whom 40 pericardial bioprostheses and 34 bileaflet prostheses sized 19, 21, or 23 mm had been implanted to replace aortic valves. MAIN OUTCOME MEASURES: Doppler echocardiography at rest and at peak exercise, between 12 and 47 months after surgery. RESULTS: All patients achieved a significant increase in heart rate, systolic blood pressure, and cardiac output with exercise. Transvalvar pressure fall, valve area, and left ventricular systolic and diastolic function indices also underwent significant changes with exercise. Reductions in peak and mean transvalvar pressure, at rest and at peak exercise, were greater in patients with small valves (p < 0.05). Valve areas and effective area index were greater in the patients with larger valves (p < 0.001). There were no significant differences between patients with mechanical and biological prostheses with regard to transvalvar pressure fall and valve areas at rest and at peak exercise. CONCLUSIONS: 19 mm and 21 mm aortic prostheses and bioprostheses continue to create significant obstruction, particularly with exercise.

Aged↗

Orthopedic spinal and hip prostheses: effects of magnetic susceptibility artifacts during MR arteriography and venography of abdomen and pelvis.

PURPOSE: To retrospectively determine if susceptibility artifacts from internal metallic spinal fixation devices and hip prostheses limit the depiction of vascular anatomy and pathologic abnormalities during magnetic resonance (MR) arteriography and venography. MATERIALS AND METHODS: This study was approved by the Committee on Human Research of the Institutional Review Board, which waived the requirement for informed consent and deemed the study to be HIPAA compliant. Forty-two contrast material-enhanced MR angiographic examinations were performed by using a 1.5-T imager in 41 patients (16 men, 25 women; mean age, 57 years; range, 36-79 years); 33 of these examinations included both MR arteriographic and MR venographic components. On the basis of resolution, images for which more than 3 mm of vessels were affected by susceptibility artifacts were considered uninterpretable. The odds of obtaining an uninterpretable image due to metallic artifacts were calculated, and a chi(2) analysis was employed to determine significance. RESULTS: Total hip prostheses and spinal hardware that terminated above the L5 level did not generate any appreciable artifacts at MR arteriography (P < .001) or MR venography (P = .002). In patients with hardware that extended to the sacrum, 88% of MR arteriograms were of diagnostic quality (P = .001), but only 21% of MR venograms were interpretable (P = .004). Artifacts limited the evaluation of the inferior vena cava and common iliac veins near the confluence. CONCLUSION: Diagnostic-quality MR arteriograms and MR venograms can be obtained in patients with artificial hip prostheses and spinal hardware terminating above the L5 level, but there is 79% likelihood of obtaining a nondiagnostic MR venogram in patients with internal spinal fixation devices that extend to the sacrum.

Adult↗

Failed temporomandibular joint prostheses: MR imaging.

Magnetic resonance (MR) imaging with surface coils was performed on 43 temporomandibular joints with disk prostheses in 28 patients who had pain, dysfunction, or both after implantation of the prostheses. Fracture was diagnosed prospectively as a discontinuity of the prosthesis on the MR examination; the sensitivity and specificity of MR imaging for this diagnosis was determined on the basis of these studies. All patients underwent surgery, after which the final diagnosis was made. MR imaging was found to have a sensitivity of 0.81 and a specificity of 0.91. Other MR findings included an abnormal amount of soft tissue surrounding the disk, thinning of the disk, osteophytes, and erosion of the condyle. An as yet unexplained artifact was frequently seen and obscured the prostheses in four of the six false-negative studies. The one false-positive case resulted from the interpretation of a markedly thinned but intact region of the prosthesis as a fracture.

Female↗

Doppler echocardiographic determination of geometric orifice areas in mechanical aortic valve prostheses.

In 63 St. Jude bileaflet and 34 Bjoerk-Shiley tilting disk aortic valve prostheses, Doppler continuity areas were compared to their corresponding geometric areas defined by the opening angle of the occluders. Continuity areas correlated significantly with geometric areas in Bjoerk-Shiley (p = 0.68) and St. Jude prostheses (p = 0.86). Differences between continuity and geometric areas were greater in St. Jude than in Bjoerk-Shiley valves (0.87 +/- 0.45 cm2 vs. 0.06 +/- 0.47 cm2, p < 0.0001). Exclusion of patients with atrial fibrillation, with a postoperative interval of less than 1 year or valve sizes of 19 and 21 mm did not change the results. Thus, underestimation of geometric areas is present in the St. Jude bileaflet aortic valves, while geometric and continuity areas are not significantly different in Bjoerk-Shiley prostheses. These results are attributable to the effect of valve-type-dependent velocity profiles.

Adult↗

Clinical experience with 80 inflatable penile prostheses.

OBJECTIVES: Prosthetic surgery for impotence has been transformed by the use of inflatable prostheses, superseding the old semi-rigid designs. Our objective is to report the functional results and the complications of this type of surgery. METHODS: 80 inflatable prostheses were implanted between October 1987 and October 1994. The mean follow-up was 3 years and assessment of the objective (mechanical functioning of the prosthesis and complications) and subjective results (sexuality of the patients) was made in 68 patients. RESULTS: There were: 54.5% functional disturbances, 7% infections, and 27.5% prosthesis removals. Most of the patients were satisfied, although only 65% returned to regular sexual activity. CONCLUSIONS: The choice between an inflatable and a semi-rigid prosthesis should be carefully discussed because of the frequent mechanical complications that have been reported for the sophisticated designs. Inflatable penile prostheses nevertheless remain the design of choice. Their reliability has been increasing since the manufacture of monobloc designs. Such a device is costly, and should be compared with that of intracavernous injections.

Adult↗

Mid-term comparative follow-up after aortic valve replacement with Carpentier-Edwards and Pericarbon pericardial prostheses.

BACKGROUND: The first generation of pericardial valves had a high rate of premature deterioration. The aim of this study was to compare the outcome after aortic valve replacement with second generation pericardial prostheses (Pericarbon and Carpentier-Edwards). METHODS AND RESULTS: Between 1987 and 1994, 162 patients underwent aortic valve replacement with either a Pericarbon (n=81, 69+/-11 years) or a Carpentier-Edwards (n=81, 70+/-11 years) pericardial prosthesis. Mean follow-up was 4.4+/-2.7 years for Pericarbon and 4.8+/-2.4 years for Carpentier-Edwards valves (P=0. 27), giving a total follow-up of 745 patient-years. Thirty-day mortality and 5-year actuarial survival were, respectively, 6.2% and 63.2+/-5.7% in the Pericarbon group and 6.2% and 63.5+/-5.6% in the Carpentier-Edwards group. At 8 years, freedom from (and linearized rates per patient-year) thromboembolism, structural failure, and all valve-related events were, respectively, 91.8+/-3.6% (1.4%), 76. 9+/-8.7% (2.5%), and 58.4+/-9.3% (5.6%) in the Pericarbon group and 94.4+/-2.7% (1%), 100% (0%, P<0.01), and 88.8+/-3.7% (2%, P<0.05) in the Carpentier-Edwards group. There were 9 (11.1%) Pericarbon structural failures related predominantly to severe calcification and stenosis. The actual reoperation rate was 7.4% (1.6% per patient-year) in the Pericarbon group for fibrocalcific degeneration (n=3), periprosthetic leak (n=1), endocarditis (n=1), and aortic dissection (n=1). There was neither structural valve failure nor valve reoperation in the Carpentier-Edwards group. Echocardiographic review of 70 patients from 85 survivors (82.3%) found 4 additional Pericarbon valves with signs of early structural failure but no Carpentier-Edwards valve with such changes. CONCLUSIONS: Eight years after aortic valve replacement, Pericarbon pericardial prostheses compared unfavorably with Carpentier-Edwards pericardial prostheses, with a high incidence of structural valve failure and reoperation.

Aged↗