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Tricuspid valve replacement: UK Heart Valve Registry mid-term results comparing mechanical and biological prostheses.

BACKGROUND: Little is known of time-related outcome and comparative performance of biological and mechanical prostheses following tricuspid valve replacement (TVR). METHODS: A retrospective UK Heart Valve Registry study (Jan 1, 1986 to June 30, 1997) identified 425 patients who underwent TVR. Two-hundred twenty-five (52.9%) received biological and 200 (47.1%) received mechanical valves. One-hundred sixty (38%), 158, and 76 had isolated, double, and triple valve replacements, respectively. The follow-up was 96% complete with a total of 1,585 patient-years. RESULTS: Thirty-day mortality for TVR was 17.3% (73 deaths). One-, 5-, and 10-year survival rates were 72.2%, 59.9%, and 42.9%, respectively. Year of operation (p = 0.04), age (p = 0.04), and number of valves implanted (p = 0.0 3) predicted overall mortality. Age (p<0.001) and year of operation (p = 0.002) predicted overall survival. Thirty-day mortality for biological and mechanical prostheses was 18.8% and 15.6%, respectively. One-, 5-, and 10-year survival rates were 70.5%, 61.5%, and 47.7% for biological and 74.0%, 57.9%, and 33.9% for mechanical prostheses, respectively. Freedom from reoperation at 1 and 10 years was 98.7% and 97.4%. Freedom from death or reoperation was 71.2% at 1 year and 41.9% at 10 years. None of the above outcomes was significantly different between the type of valve prostheses. CONCLUSIONS: TVR carries a high 30-day mortality and a poor longer term survival. No superiority could be identified for biological or mechanical prostheses in the tricuspid position for either survival or reoperation.

Bioprosthesis↗

Strength requirements for internal and external prostheses.

Throughout the history of development of joint replacement implants and external prostheses there have been mechanical failures due to a discrepancy between material strength, cross-sectional characteristics and the loads developed in normal or abnormal function by the patient utilising the device. Particularly for internal prostheses attention is being paid at the present time to wear characteristics and the requirements for the articulating surfaces and the volume of wear particles produced during tests simulating the use of the device within the patient. The particular importance of the wear particles is that they seem to be associated with accelerated resorption of bone at areas essential for successful fixation of the implant within it. This article will consider joint replacements at the knee and hip and external prostheses for the leg. If failure due to external trauma is ignored the loads to be considered in testing standards correspond in implants to the muscular and ligamentous forces related to the forces developed between ground and foot and to the bending moments in the structure of leg prostheses. Generally it can be assumed that the treatment of the patient following trauma is more easily accomplished and more likely to be successful if the prosthesis has failed and not the bony structure of the patient. However, the author is unaware that these devices have ever been designed to have lower intrinsic strength than the anatomical structures to which they are connected; indeed in many cases particularly for implants they are much stronger than the bone to which they are connected. The major difficulty in rational design of prosthetic devices has been uncertainty about the importance of occasionally applied loads of a high value relative to those on a frequent basis and also to the frequency of application of these overloads. In this paper consideration is given to methods of determination of load systems relevant to the mechanical performance of implanted joint replacements at the hip and the knee and external prostheses for leg amputees. New data are presented relating to walking, other daily activities and the corresponding frequency of occurrence of these. Loading data on implants obtained by various biomechanical models is compared and related to the loads actually measured by implanted transducers. The philosophy of the standardised test load systems and the performance requirements is reviewed.

Activities of Daily Living↗

An evaluation of facial prostheses.

A survey was conducted to evaluate patient reactions to facial prostheses that were provided to 143 patients in the past 7 years at Roswell Park Memorial Institute. Of the 76 patients who responded, 38 patients were wearing their prostheses and 38 patients were not wearing their prostheses. Reasons cited by the patients for not using their prosthesis included lack of retention, additional surgery, discomfort, and irritation. Most of the prostheses were prepared in silicone rubber with color characterization accomplished by the tattooing method. More than 69% of the prostheses were remade within a year because of rapid changes in the defect, prosthesis material, or prosthesis color. The study revealed the need for improvement in materials, adhesive techniques, and the psychological orientation of the patient. This project was conducted at a teaching and research institute. No fees for the patients were required. Therefore our data might differ from that collected from a private practice or clinic.

Adult↗

Lipid uptake in synthetic vascular prostheses explanted from humans.

Previous in vivo studies in humans and dogs have revealed an atherosclerosis-like phenomenon in which lipid penetration within arterial prosthesis wall was observed. The primary goal of the present study was therefore to investigate the occurrence of this lipid retention in ePTFE prostheses implanted in humans and therefore identify potential risk factors related to this phenomenon. Lipid uptake in 367 ePTFE microporous vascular prostheses explanted from humans was studied using Fourier transform infrared spectroscopy. The assignment of the infrared absorption features clearly revealed the presence of strongly bonded unsaturated fatty acids to the microporous structure of the prostheses. A one-way ANOVA statistical analysis showed that the lipid uptake in the synthetic vascular prostheses depended on the duration of implantation of the prosthesis and on the sex of the patient. A two-way ANOVA showed that a relationship existed between the estimated lipid uptake and the internal diameter of the prosthesis. These results confirm that the lipid uptake phenomenon depends on some clinical factors related either to the patients or to the prostheses' morphological parameters.

Aged↗

The influence of surgical malalignment on the contact pressures of fixed and mobile bearing knee prostheses--a biomechanical study.

OBJECTIVE: To investigate the effect of surgical malalignment on contact pressures of fixed and mobile bearing knee prostheses. DESIGN: An experimental set-up was used to measure contact pressure on the tibial component of fixed and mobile bearing knee prostheses subjected to a compression load and surgical malalignment situations were simulated. BACKGROUND: Mobile bearing knee prostheses were designed to decrease tibiofemoral contact pressure by providing both high congruity and mobility. It was also assumed to accommodate surgical malalignment. However, few studies have reported the effect of malalignment of the tibiofemoral joint on contact pressure of fixed and mobile bearing knee prostheses. METHODS: Surgical malalignment situations were simulated to evaluate contact characteristics of tibial component of fixed and mobile bearing knee prostheses. The simulated malalignment conditions include the medial-lateral translation (0.5 and 1 mm), anterior-posterior translation (2 and 4 mm) and internal-external rotation (1 degrees, 3 degrees, 5 degrees and 10 degrees ) of the femoral component relative to the tibial component. Fuji pressure sensitive film was used to measure the contact pressure. RESULTS: The greatest increase of maximum contact pressure in the anterior-posterior maltranslation was 7.63% and 7.62% relative to the neutral contact situation in the fixed and mobile bearing designs respectively. In the medial-lateral maltranslation, there was 23.3% in the fixed bearing design and was 22.0% in the mobile bearing design. In the internal/external malrotation, the greatest increase of maximum contact pressure in the fixed bearing design was 27.1%, which was much higher than the mobile bearing design (22.4%). CONCLUSIONS: The mobile bearing design can reduce maximum contact pressure more significantly than the fixed bearing design when malalignment conditions of the tibiofemoral joint occurs, especially in the internal/external malrotation. The mobile bearing design offers the advantage of self-adjusting over the fixed bearing design to accommodate surgical malalignment. RELEVANCE: This study revealed that the mobile bearing design has smaller maximum contact pressures than the fixed bearing design in knee prosthesis under malalignment biomechanical tests. This result indicates that there is an advantage for a mobile bearing design over a fixed bearing design to accommodate malalignment conditions caused by surgical technique or soft tissues imbalance in total knee arthroplasty.

Arthroplasty, Replacement, Knee↗

A new approach of designing the tibial baseplate of total knee prostheses.

OBJECTIVE: To improve the design of the knee prosthesis, a new technique to design the tibial baseplate of total knee prostheses was developed. METHODS: One senior surgeon operated on 79 osteoarthrosis patients by using PCA total knee prostheses for total knee replacement. Four dimensions were measured intraoperatively and compared, including the anterioposterior length and the mediolateral width of the resected tibia plateau and implant. The data of anterioposterior length and the mediolateral width of resected surfaces of the tibial plateau of the 79 patients were plotted in a coordinate system. This coordinate system was formed with the mediolateral width as the x-axis and anterioposterior length as the y-axis. A circle, 5 mm in diameter, was used as the maximum coverage criterion. Five contemporary products and a new design product were used to screen the data to see how many patients would fall within the criteria. From the results of the screened data, we calculated the coverage percentage of the patients. RESULTS: The ratio of the anterioposterior length to the mediolateral width of the resected surfaces of the tibial plateau was greater than that of the ratio of the PCA prostheses (P < 0.05). The results showed that no single product on the market had the patients meet over 70% of the criterion. A different ratio of the anterioposterior length to the mediolateral width was designed to achieve 90% coverage of the patients that met the criterion. DISCUSSION: One possible explanation for the discrepancy between resected surfaces and implants is that the osteoarthrosis patients developed knee deformities that changed the surface of the tibial plateau and thus altered the knee dimensions. Since the total knee prostheses were used on osteoarthrosis patients, the dimensions of the resected tibial surfaces of osteoarthrosis patients should be considered in the design of the tibial baseplate of total knee prostheses.

Aged↗

Comparative evaluation of the effect of diameter, length and number of implants supporting three-unit fixed partial prostheses on stress distribution in the bone.

OBJECTIVES: The purpose of this study was to compare the effects of the diameter, the length and the number of implants on stress distribution in the bone around the implants supporting three-unit fixed partial prostheses in the mandibular posterior edentulism. MATERIALS AND METHOD: A mandibular Kennedy II three-dimensional finite element model was constructed. Four fixed partial prostheses with two terminal implant supports of various lengths and diameters, and two fixed partial prostheses with three implant supports of various lengths were designed. In separate load cases, 400 N oblique, 200 N vertical, and 57 N horizontal forces were simulated. The tensile and the compressive stress values in the cortical bone around the collar of the implants and Von Mises stresses in the implants were evaluated. RESULTS: Although the change in the length of implants did not decrease the stress levels, lower tensile and compressive stress values were observed in the bone for wider implant placement configurations. Similar stress distributions and close stress levels were observed for two wider implant supports in comparison with the three-implant-supported fixed partial prostheses. CONCLUSION: With the use of two implants of 4.1-mm diameter and 10-mm length as terminal supports for three-unit fixed prostheses, the magnitude and the distribution of stresses in the cortical bone around the implant collar is within the normal physiological limits.

Bicuspid↗

The role of cinefluoroscopy and intravascular ultrasonography in evaluating the deployment of experimental endovascular prostheses.

PURPOSE: This study compares the utility of cineangiography and real-time intravascular ultrasonography (IVUS) in achieving successful deployment of endovascular prostheses. METHODS: Five types of 5 cm long, 8 mm internal diameter polyester vascular grafts were secured in the infrarenal aorta of mongrel dogs by 18 mm long Palmaz balloon expandable vascular stents sutured to each end of the prostheses. The endovascular prostheses were delivered by crimping the stents at the ends of the grafts onto a 10 mm outside diameter, 8 cm long polyethylene balloon-dilation catheter. Real-time IVUS of the procedure was provided by a 0.035-inch, 20 MHz imaging element passed through the guide wire lumen in the balloon catheter. Two prostheses of each type were implanted, with one removed at 30 days and the other at 60 days for analysis. RESULTS: At implantation, both angiography and IVUS provided information regarding the choice of site for placement of the device and sizing of the aortic lumen. Real-time IVUS enhanced the information obtained by cineangiography by displaying tomographic views of the vessel anatomy, enabling determination of cross-sectional areas, assessing full stent expansion, and providing information regarding surface topography along the length of the prostheses. Several critical observations were apparent only on IVUS, including incomplete initial stent expansion during two procedures evidenced by pulsation of the aortic wall independent of the stent and movement of unstented segments of thin-walled grafts. Some of these observations led to further interventions at the time of deployment. At death, a comparison of cineangiography, IVUS, and ultrafast computed tomography outlined lumenal continuity and areas of irregularity, thrombus, or narrowing, with IVUS being more sensitive than cineangiography or computed tomography for determining most parameters. CONCLUSIONS: We conclude that IVUS is a promising alternative method for precise placement of intravascular grafts.

Animals↗

Joint motion of bipolar femoral prostheses.

From 1982 to 1992, 251 bipolar hip arthroplasties were performed on 213 patients. Among them, 117 bipolar femoral prostheses were randomly selected to examine the behavior of abduction motion under weight-bearing loads. Roentgenographic motion study was performed at an average of 46.5 months after surgery (range, 2-110 months). One hundred one prostheses used in dysplastic osteoarthritic, rheumatoid, and revised failed total hip arthroplasty patients moved 18.2% at the outer bearing and 81.8% at the inner bearing, while 16 prostheses used in femoral neck fracture and osteonecrosis of the femoral head patients moved 49.7% at the inner bearing and 50.3% at the outer bearing. There was a statistical difference in the motion pattern between the two groups. The abduction motion behavior of the bipolar femoral prostheses was not affected by the length of the follow-up period, the diameter of the outer heads, or the position of the prostheses on immediate postoperative roentgenograms.

Arthritis, Rheumatoid↗

Long-term comparison of the Charnley, Muller, and Trapezoidal-28 total hip prostheses. A survival analysis.

Seven hundred ninety-one total hip arthroplasties (242 Charnley prostheses, 146 Muller prostheses, and 403 Trapezoidal-28) performed between 1969 and 1980 by one surgeon were evaluated using survival analysis to predict success and/or failure over time. Only 6.4% of the population was excluded because of failure to return for follow-up evaluation. All other patients were included in the analysis. It is expected that at 10 years after operation, 91% of the Charnley, 88% of the T-28, and 80% of the Muller prostheses will survive (P less than .05). The acetabular cup of the Muller prosthesis showed significant premature loosening, compared with the Charnley and T-28 prostheses (P less than .0001 and P less than .05, respectively). The Muller femoral stem was inferior only to the Charnley (P less than .025). The T-28 femoral stem showed no difference in success compared with the other two prostheses, despite 10 T-28 femoral stem fractures. Multivariate survivorship regression analysis revealed significant factors that may have predisposed the above failures. Women (P less than .0005) and older patients (P less than .0005) had significantly higher success rates. Significant intrinsic factors included radiolucency about the entire acetabular bone-cement interface (P less than .0005), fracture in the acetabular cement (P less than .005), and radiolucency about the entire femoral bone-cement interface (P less than .0005).

Age Factors↗

Regurgitant flow of mitral valve prostheses: an intraoperative transesophageal echocardiographic study.

To assess the regurgitant characteristics of mitral biologic and mechanical prostheses immediately after implantation, intraoperative transesophageal echocardiography was performed in 27 patients, aged 32 to 69 years, undergoing open-heart surgery for rheumatic heart disease (n = 19), mitral valve prolapse (n = 3), malfunctioning prostheses (n = 3), or periprosthetic leaks (n = 2). The prostheses included 13 biologic (Carpentier-Edwards) and 14 mechanical valves (five Starr-Edwards, five Medtronic-Hall, and four Bjork-Shiley). Physiologic transvalvular regurgitant flow was detected in both biologic and mechanical prostheses. The spatial extent of the regurgitant jets was usually greater in the mechanical than in the biologic valves, and systolic jets, characteristic of each type of valve, were visualized consistently. Trivial periprosthetic jets (PPJs) were observed in many implanted valves (14/27). The median maximal jet area was 0.46 cm2 (range 0.1 to 1.5 cm2). Cardiopulmonary bypass was reinstituted in two patients. In one patient a PPJ was judged extensive enough (area 3.6 cm2) to warrant surgical revision of the implant, but no dehiscence was found. In the other patient a turbulent PPJ (area 5.5 cm2) was associated with a 0.5 cm dehiscence at the surgical inspection. In conclusion, (1) all mitral prostheses exhibit physiologic transvalvular regurgitation, (2) trivial mitral PPJ is a common finding in newly implanted mitral valves and does not require the revision of the implant, and (3) further experience based on larger series of patients is required to determine the maximal acceptable size of a mitral PPJ detected by intraoperative transesophageal echocardiography.

Bioprosthesis↗

Predicting the use of prostheses by vascular amputees.

OBJECTIVE: To evaluate our accuracy in predicting the use of prostheses by patients undergoing major lower limb amputation. DESIGN: Prospective study, with multiple assessors, "blind" to the predictions made by each other. MATERIALS: Sixty-one patients (35 male: age 51-91, median 79) having their first major lower limb amputation. METHODS: Five members of the rehabilitation team (surgeon, specialist in prosthetics, nurse, physiotherapist and occupational therapist) each recorded predictions of prosthetic use and mobility before amputation and during the first 2 weeks thereafter. Patients were followed up 6-24 months later. RESULTS: At follow-up 17 patients had died. Of the remaining 44 (25 below-knee and 19 above-knee amputees), 23 of 27 (85%) who had been predicted as using prostheses were doing so, while only 11 of 17 (65%) had been correctly predicted as non-users. Nevertheless, only two of the patients not using prostheses contrary to prediction had ever had prostheses made for them, and both had developed problems with the other leg at a later date. Different members of the rehabilitation team were similar in their ability to predict outcome. CONCLUSIONS: Inappropriate fitting of prostheses can be kept to a minimum by a team approach to rehabilitation, but amputees may defy careful prediction by the development of new medical problems.

Aged↗

Glycosaminoglycans in peri-implant sulcus fluid from implants supporting fixed or removable prostheses.

Previous studies have indicated that examination of glycosaminoglycans (GAG) present in peri-implant sulcus fluid (PISF) may be a useful indicator of metabolic activity of the supporting bone. The GAG content in PISF from osseointegrated implants ad modum Brånemark in the maxilla was quantified and analysed. The study comprised 2 groups with 10 patients in each group. In one group the patients wore removable prostheses; in group 2 the patients wore fixed prostheses. The groups were matched for age, sex and function period of their prosthetic appliances. Clinical data were recorded, and the levels of the GAG hyaluronan (HA) and chondroitin-4-sulphate (C4S) were assessed using cellulose acetate electrophoresis and densitometric scanning of Alcian blue-stained strips against known GAG standards. PISF volumes and levels of C4S as potential bone marker showed no significant difference (both groups median 0.003 microgram). There was a somewhat higher median value for HA (0.015 microgram) in the group of patients with removable prostheses compared with the group with fixed prosthesis (HA = 0.008 micrograms) (NS). HA is known to be present in high amounts in gingival tissue. As both plaque index and gingival bleeding were more frequent in patients with removable prostheses, this may be the reason for the somewhat higher value for HA in this group of patients. The difference in biomechanical properties of fixed and removable prostheses on implants do not appear to be reflected in the bone responses as measured by GAG content in PISF.

Aged↗

Magnitude and distribution of occlusal forces on oral implants supporting fixed prostheses: an in vivo study.

Since loading is increasingly believed to be a determining factor in the treatment outcome with oral implants, there is a need to expand the knowledge related to the biomechanics of oral implants. The aim of this study is to gain insight in the distribution and magnitude of occlusal forces on oral implants carrying fixed prostheses. This is done by in vivo quantification and qualification of these forces, which implies that not only the magnitude of the load but also its type (axial force or bending moment) will be registered. A total of 13 patients with an implant supported fixed full prosthesis were selected. Occlusal forces on the supporting implants were quantified and qualified during controlled load application of 50 N on several positions along the occlusal surface of the prostheses and during maximal biting in maximal occlusion by use of strain gauged abutments. The test was conducted when the prostheses were supported by all (5 or 6) implants and was repeated when the prostheses were supported by 4 and by 3 implants only. Despite considerable inter-individual variation, clear differences in implant loading between these test conditions were seen. Loading of the extension parts of the prostheses caused a hinging effect which induced considerable compressive forces on the implants closest to the place of load application and lower compressive or tensile forces on other implants. On average, higher forces were observed with a decreasing number of supporting implants. Bending moments were highest when 3 implants only were used.

Adult↗

A comparison of hydroxylapatite coated implant retained fixed and removable mandibular prostheses over 4 to 6 years.

In a 6-year prospective clinical study, 181 hydroxylapatite coated endosseous dental implants were placed into the anterior mandible of 48 patients. Twenty-one patients were treated with fixed prostheses and 27 patients with an overdenture. When the implants were exposed all 181 had integrated. To date, there is 100% survival of all implants and they all retain a functioning prostheses. The initial results were very promising, in both groups the interval success was over 95% in the first 4 years of the study. However, by year 6, the interval success rates had fallen to 83% for both the fixed and removable groups. This study also compares the construction and maintenance complications for the two types of restorations. The clinical time taken, after implant exposure, to construct the prostheses was similar whether the fixed (mean of 8 visits) or removable option (mean of 7 visits) was chosen. However, the removable restoration cost less than half the price of the fixed when both technical time and implant component costs were evaluated. Maintenance for both groups was higher than expected, but patients required more appointments in the removable group both in the first year and beyond. Regarding the prostheses itself, the incidence of remakes, relines and general adjustments was higher in the removable group. This study has shown that the overdenture offers an effective and initially a more economical alternative to the fixed prostheses, in the treatment of the edentulous mandible. However, long-term maintenance of such a prosthesis can be significant.

Adult↗

Effects of silicone breast prostheses on the assessment of body composition by dual-energy X-ray absorptiometry.

We examined the influence of silicone breast prostheses on body composition as assessed by dual-energy X-ray absorptiometry (DXA). Eighteen women were measured with and without a pair of silicone breast prostheses placed on the upper part of the trunk simulating endogenous implants. Bone area, bone mineral content (BMC), areal bone mineral density (BMD), lean tissue mass (LTM) and fat tissue mass (FTM) of the total body and of the subregions of the body, i.e. the head, trunk, arms and legs, were measured by a Norland XR-36 DXA scanner. After application of the silicone prostheses, bone area, BMC and BMD of the total body significantly increased by an average of 3.7, 6.6 and 3.4% (P<0.0001), respectively. Total body LTM and FTM were not affected. In the trunk region, changes were more pronounced. Trunk BMC, for example, was overestimated by 17.9% (P<0. 0001). The prostheses also influenced measurements of truncal soft tissue composition, with a small but statistically significant overestimation of both LTM (1.1%) and FTM (2.1%) (P<0.05). No changes in bone mass and soft tissue composition were seen in the head, arms and legs. Activation of a high-density detection software utility provided by the manufacturer had no influence on any of the measurements. We conclude that silicone breast prostheses affect the assessment of body composition by DXA.

Absorptiometry, Photon↗

Rehabilitation of biting abilities in patients with different types of dental prostheses.

This study investigated the masticatory rehabilitation of subjects wearing different types of prostheses. Biting abilities per person (biting force, biting pressure and occlusal contact area) were assessed with a pressure detecting sheet (Prescale(R)). Five hundred and ninety volunteers were divided into four groups according to the type of posterior dentition: complete denture, removable partial denture, fixed partial denture, and full natural dentition groups. The biting forces of the fixed partial, removable partial and complete denture wearers were 80, 35 and 11% respectively, when expressed as a percentage of the subjects with a natural dentition. The complete denture wearers showed the highest biting pressure among the four groups, followed by the removable partial denture wearers. In a clinical intra-individual study, the biting abilities of 85 subjects, without (before insertion of) and with (after insertion of) renewed prostheses, were compared. No significant differences were found between biting before and immediately after insertion of the prostheses. However, the biting force and occlusal contact area increased 2 months after insertion of the prostheses. This study confirmed past clinical studies indicating an impaired masticatory function of denture wearers. The functional adaptation to new prostheses had improved at evaluation 2 months after insertion.

Adaptation, Physiological↗

An in vitro methodology for evaluating the mechanical properties of aortic vascular prostheses.

The main problem in the replacement of pathological segments of the aorta with vascular prostheses consists of matching the fluid admittance of the host artery and the graft. This mismatch results from the different compliance between natural and prosthetic vessels and from the plastic dilatation of the prosthesis diameter that occurs after implantation. An experimental procedure was set up for evaluating the mechanical properties of aortic vascular prostheses. An MTS 858 MiniBionix testing machine was equipped with a purposely designed testing apparatus, which allows loading a ring-shaped prosthesis specimen with forces that can be related easily to the transmural pressure acting on the prostheses in vivo. The reference pressure waveforms are simulated from a lumped parameter model of the cardiovascular system. Preliminary tests on 3 different (woven, warp knitted, and carbon-coated warp knitted fabric) aortic prostheses point out a good reproducibility of the results. The fabric strongly affects the circumferential elasticity and the dimensional stability of the graft. Simulation of hypertension promotes larger diameter dilatation and reduction in compliance. Agreement between in vitro and clinical diameter measurements has been assessed for 8 prosthesis samples and found to be adequate. This method is thus a potentially useful means for preclinical evaluation of compliance of vascular prostheses for the purpose of matching to native vessels.

Aged↗