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Heart valve replacement with the Björk-Shiley and St Jude Medical prostheses: a randomized comparison in 178 patients.

In 178 patients, a randomized prospective comparison between the 60 degrees spherical disc Björk-Shiley (BS) and the St Jude Medical (SJM) heart valve prostheses was performed. Four-week perioperative mortality was zero in the BS (n = 84) and 4.3% in the SJM group (n = 94). During a mean (+/- SD) follow-up of 52 +/- 20 months or 778 patient-years, late cardiac mortality per year was 2.4% in the BS and 2.2% in the SJM group. The yearly thromboembolic rates were 1.4% in the BS and 2.0% in the SJM group. There was no mechanical valve failure or haemolytic anaemia. Paravalvular leaks and major bleeding complications occurred at low rates in both groups (1.1% and 2.2% per year in BS; 0.7% and 1.7% per year in SJM). Functional results were similarly good with 96% of patients with BS valves and 95% of patients with SJM prostheses being in NYHA classes I and II, respectively. We conclude that heart valve replacement with mechanical prostheses can be performed with equally good results using either the Björk-Shiley spherical disc valve or the St Jude Medical bileaflet prosthesis.

Aged↗

Changes seen in lymph nodes draining the sites of large joint prostheses.

We report the histological findings seen in the lymph nodes draining the sites of large joint prostheses. Two patients underwent multiple prosthetic joint replacements. In one patient, the regional lymph nodes were enlarged during the revision of a total hip prosthesis, and a representative lymph node was resected. The other patient had undergone a pelvic lymph node dissection as part of a staging procedure for prostatic carcinoma. By light microscopy, the lymph nodes from both patients showed markedly dilated nodal sinuses filled with macrophages containing abundant eosinophilic, PAS-positive, granular material. Polarization microscopy revealed needle-like particles within the cytoplasm of the macrophages. We believe that the histological appearance of the lymph nodes represents a florid foreign body reaction to fragments of polyester or polyethylene derived from the articulating surfaces of the joint prostheses and transported to the regional lymph nodes via the lymphatic circulation. Sinus histiocytosis seen in the lymph nodes draining the sites of joint prostheses may resemble, and must be distinguished from, other conditions invoking a sinus pattern of lymphadenopathy, as well from benign and malignant diseases that involve the lymph nodes in a pattern mimicking sinus histiocytosis.

Adult↗

Analysis of silicon levels in capsules of gel and saline breast implants and of penile prostheses.

Although a potential link between silicone-gel breast implants and autoimmune connective tissue disease has been suggested, none has been proven. The potential role of silicone as an immune adjuvant remains very controversial. Currently available techniques do not allow precise measurements of silicone in tissues. However, all compounds containing silicon (including silicone) can be measured accurately. The present study was designed to measure silicon levels in the fibrous capsules of patients with silicone-gel breast implants, saline breast implants, and silicone inflatable penile prostheses. Baseline control silicon levels were obtained from the breast tissue of patients undergoing breast reduction, who had no exposure to breast implants. All silicon measurements were carried out using atomic absorption spectrometry with a graphite furnace. Silicon was measured in a normal heptane extract of silicone from dried tissue. The mean silicon levels in 16 breast tissue control samples from 8 patients undergoing breast reduction varied from 0.025 to 0.742 micrograms/gm with the median mean being 0.0927. The median silicon level in capsules from six patients with saline implants was 7.7 micrograms/gm (range, 1.9-36.6 micrograms/gm). The median silicon level in capsules from five patients with silicone inflatable penile prostheses was 19.5 micrograms/gm (range, 1.9-34.8 micrograms/gm). Although the levels of silicon in capsules of patients with saline breast prostheses and penile implants were higher than in control samples, they were much lower than those from the capsules of the 58 gel implants (median, 9,979 micrograms/gm; range, 371-152,000 micrograms/gm).(ABSTRACT TRUNCATED AT 250 WORDS)

Breast↗

Seeding arterial prostheses with vascular endothelium. The nature of the lining.

Arterial prostheses seeded with autogenous vascular endothelium demonstrate a well-organized, cellular, inner lining. To determine the nature of the lining cells, six animals underwent replacement of the infrarenal aorta with Dacron prostheses. During the preparation of three such grafts, endothelium was scraped from the saphenous vein with a steel wool pledget, suspended in chilled Sack's solution, and mixed with blood used to preclot the graft. This suspension was omitted from the three control grafts. After six weeks, the grafts were removed, rinsed and examined. Fluorescent Factor VIII related antigen (F VIII-RA) strongly stained the lining cells. Silver nitrate Haütchen and electron microscopy preparations revealed a lining pattern characteristic of vascular endothelium. Endothelial cell-specific Weibel-Palade bodies were identified in the lining cell cytoplasm. Masson's trichrome staining revealed a relatively collagen-poor connective tissue within the seeded fabric. Transmission electron microscopy disclosed vascular smooth muscle cells between the seeded graft fabric and the lining cells. Vasa vasorum, arising from the outer capsule, penetrated the fabric to supply the inner capsules of the seeded grafts. It is concluded that the cells lining seeded canine arterial prostheses are true vascular endothelium supported by vascular smooth muscle cells, that the lining contains minimal connective tissue, and that vasa vasorum develop. Unseeded control grafts lacked these features.

Animals↗

Proprioceptive function, clinical results, and quality of life after unicondylar sledge prostheses.

OBJECTIVE: Evaluation of proprioceptive performance and quality of life after implantation of unicondylar sledge knee prostheses in comparison with normal control subjects. DESIGN: A total of 17 patients were examined after implantation of unicondylar sledge prostheses. Clinical examination was performed, quality of life was assessed, and proprioceptive performance was examined. A total of 11 healthy subjects of comparable age served as a control group. RESULTS: Clinical results of both groups differed significantly in all categories. Quality-of-life assessment differed only in the following items: physical functioning, role limitation caused by physical problems, and bodily pain. Other than angle reproduction at 15 degrees, no significant differences in proprioceptive testing, neither sway measurement nor angle reproduction, were found. Statistical analysis revealed no correlation between clinical scores and proprioceptive results. CONCLUSIONS: In comparison with normal control subjects of comparable age, the implantation of unicondylar sledge prostheses does not result in proprioceptive deficits. Except for physical functioning, role limitations caused by physical problems and bodily pain, most aspects of quality of life do not differ between patients and control subjects, although the patients' clinical results were significantly lower than the controls.

Aged↗

Laxity in posterior cruciate sparing and posterior stabilized total knee prostheses.

Two series of consecutive total knee replacements were compared retrospectively: 118 HLS II posterior stabilized prostheses (Group 1) versus 138 HLS CP posterior cruciate ligament sparing prostheses (Group 2). Both implants were made by the same manufacturer. The prostheses had been inserted between 1989 and 1992. Mean followup was 4 years. The authors looked for evidence of laxity in the coronal and the sagittal planes, the correlation of laxity with other factors, and the effect of laxity on the objective and subjective outcome as measured with the Knee Society score. Group 2 had significantly more clinical and radiologic laxity. There was little difference between the two groups regarding the overall objective and subjective outcome; however, there was a significantly higher rate of excellent results in Group 1. Longer followup will be required to see whether the implants with laxity are at heightened risk for tibial component wear.

Adult↗

A randomized trial of hydroxyapatite coated prostheses in total hip arthroplasty.

In a prospective randomized trial, 62 consecutive primary cementless total hip arthroplasties in 55 patients were performed by one surgeon using either hydroxyapatite coated (35 hips) or nonhydroxyapatite coated femoral prostheses (27 hips). The dual tapered femoral stem had a Ti-6AI-4V plasma sprayed circumferential proximal porous coat applied to the proximal 1/3 of the stem. The middle 1/3 had a roughened blasted textured surface, and the distal 1/3 had a smooth surface. The hydroxyapatite coated femoral stems had an additional hydroxyapatite coating applied to the proximal porous coat with use of an air plasma process. The patients in the two groups were not significantly different regarding age (48.2 +/- 9.0 years hydroxyapatite group, 50.4 +/- 8.7 years control group), gender, Charnley class, or length of followup (4.4 +/- 0.7 years hydroxyapatite group, 4.9 +/- 1.0 years control group). Forty-nine patients (54 hips) were available for clinical followup, and 45 patients (50 hips) had radiographic followup. A minimum 3-year followup was recorded. To date, there have been no femoral prostheses failures. No femoral implant has migrated or subsided. Radiographically, the hydroxyapatite coated stems showed trends toward increased distal stem related cortical hypertrophy, increased cancellous condensation and less endosteal cavitation. Two nonhydroxyapatite coated stems had distal endosteal cavitation, whereas no hydroxyapatite coated stems did. There were two cases of acetabular osteolysis (revision in one) and two cases of acetabular cup migration (nonrevised), all occurring in the control group. The overall revision rate was 4%. There was no difference in Harris hip scores at 6 months (80.6 +/- 13.0 points hydroxyapatite group, 83.8 +/- 12.4 points control group) or at last followup (85.6 +/- 15.4 points hydroxyapatite group, 89.7 +/- 13.4 control group). The Harris hip pain scores also were not significantly different at 6 months or at last followup. Multiple linear regression analysis controlling for age, gender, and length of followup revealed no significant predictors of Harris hip or pain scores. The results of this study at an average of 4.6 years do not indicate a significant clinical advantage to the use of hydroxyapatite coated femoral prostheses in primary cementless total hip arthroplasty when judged by the criteria of Harris hip scores and femoral stem survivorship.

Acetabulum↗

In vivo laxity of low contact stress mobile-bearing prostheses.

A stress arthrometric study was done on 60 knees in 54 patients with total knee arthroplasties using a Telos arthrometer, to determine anteroposterior and abduction and adduction laxity and to evaluate the relationship between laxity and retention of the posterior cruciate ligament using low contact stress mobile-bearing prostheses. Thirty knees had posterior cruciate ligament-retaining and 30 had posterior cruciate ligament-sacrificing prostheses. The selected patients had successful knee arthroplasty 6 months previously. Anteroposterior displacement was measured at 30 degree and 90 degree flexion; there were no statistically significant differences between the posterior cruciate ligament-retaining (10.5 mm at 30 degree, 9.3 mm at 90 degree) and posterior cuciate ligament-sacrificing (9.8 mm at 30 degree, 9.7 mm at 90 degree) groups. Abduction and adduction were between 0 degree and 20 degree flexion, there were no significant differences between the two groups. Because all the patients in this study had good clinical results, approximately 10 mm anteroposterior displacement and 4 degree laxity in the coronal direction are considered favorable in low contact stress mobile-bearing prostheses of both designs.

Aged↗

The role of proximal femoral support in stress development within hip prostheses.

Bone remodeling commonly associated with implant loosening may require revision total hip replacement when there is substantial proximal femoral bone loss. Additionally, the surgical exposure required to remove primary implants may alter the proximal femur's structure. As a result, in many revision hip situations the proximal femur provides compromised support for the revision femoral component. Stress analyses of the proximal femur with extensively porous-coated prosthetic femoral components show that proximomedial femoral bone loss, ununited femoral osteotomy, and periprosthetic fracture can result in significant elevation of stress within revision prosthetic components. The first principal stress within prosthetic components can, in proximal bone loss conditions, be elevated significantly above a revision prostheses' fatigue strength. Loss of proximomedial bone is predicted to increase stress within a revision component by as much as 82%. An unhealed transverse femoral fracture or osteotomy is predicted to more than double the stress within a revision femoral component. In revision total hip replacement, efforts directed toward the restoration of proximal femoral bone and the use of larger prostheses may contribute to avoiding prostheses fatigue fracture. Similarly, protected weightbearing in patients with ununited femoral osteotomies and periprosthetic fractures may be important to preventing prosthetic fracture.

Arthroplasty, Replacement, Hip↗

Acute thrombogenicity of arterial prostheses exposed to reduced blood flow in dogs: effects of heparin, aspirin, and prostacyclin.

Thrombogenesis is considered the principal cause of early failure of arterial grafts. Although antithrombotic drugs are recommended, their efficiency under low blood flow conditions is still being debated. In this study, we evaluated the ability of three drugs to modify the thrombotic properties of blood and, consequently, to influence platelet and fibrin deposition on the luminal surface of polyester arterial prostheses. In dogs receiving saline (control, n = 10), heparin (100 U/kg, n = 5), aspirin (325 mg, n = 5), or prostacyclin (15 ng/kg/min, n = 5), a 30-cm, woven, loop-shaped, DeBakey arterial prosthesis was implanted as a substitute for the infrarenal aorta and exposed to reduced blood flow (50 ml/min) for 4 h. The parameters of the blood measured included activated clotting time (ACT) and platelet aggregation with collagen, determined before and after each treatment. Blood deposits were quantified using 111In labeled platelets and 125I-labeled fibrinogen. The ACT was significantly prolonged only after heparin treatment, and platelet aggregation, which was decreased by 35% (p < 0.05) after heparin treatment, was almost abolished after aspirin and prostacyclin treatments. As compared with the control group, both platelet and fibrin uptake on the luminal surface of the prostheses were reduced significantly by heparin by 87 and 37%, respectively. Despite their inhibition of platelet aggregation in vitro, aspirin and prostacyclin induced no significant change in platelet and fibrin deposition on the luminal surface of the woven polyester arterial prostheses under low blood flow conditions. Under such conditions, however, thrombin generation with subsequent platelet-fibrin deposition was prevented by use of heparin anticoagulant therapy.

Administration, Oral↗

Computer-designed prostheses for orbitocranial reconstruction.

Three-dimensional imaging is an adjunct to preoperative evaluation and surgical management in some patients with complex anatomic defects of various etiologies. Deformities defined by conventional computerized tomography can be viewed as accurate three-dimensional images calculated from the original scan. The images are viewed on a high-resolution video monitor and can be photographed for a permanent record. A computer-controlled milling device can use these data to fabricate prostheses. The prostheses aid reconstructive surgery through use as an alloplastic implant, as a template to fashion autogenous bone grafts, or as a model for tissue removal. We have utilized three-dimensional imaging in combination with computer-assisted prosthesis manufacture in six patients with complex orbitocranial deformities. Four patients have undergone reconstructive surgery with satisfactory results and no complications thus far. The use of computer-designed prostheses adds a new aspect to orbitocranial reconstructive surgery that facilitates increased accuracy in the correction of anatomic defects.

Adolescent↗

Reconstruction of rat femoral veins with microvascular prostheses.

Synthetic conduits have not been suitable for microvascular reconstruction owing primarily to their high thrombogenicity. Vein replacements are the most vulnerable to thrombosis because of their low shear rates and low pressure. Experimental replacement of microvenous segments with prosthetic segments has shown little success. Recent technological advances in biomaterials and control of thrombogenesis provide the potential for success in the development of venous prostheses. The purpose of this study was to assess the use of nonbiodegradable composite polyurethane microvascular prostheses for reconstruction of rat femoral veins. Rat femoral venous defects of 10 mm were reconstructed with autogenous vein (n = 12), unprocessed plain polyurethane (n = 5), and nonbiodegradable composite polyurethane (n = 31). Patency was evaluated by direct observation and proximal venous milking tests. The patency rate of composite grafts was not significantly different from that of isotopic vein (p = 0.5, Fisher's exact test), and both had higher patency than unprocessed polyurethane (p less than 0.01). Composite grafts were examined sequentially using light and scanning electron microscopy. Grafts were fully endothelialized between the first and third months. The neointimal, neomedial, and neoadventitial layers could be seen more distinctly over time. New opportunities in reconstructive microsurgery may be opened by microvascular prostheses that are complaint and thromboresistant.

Animals↗

The coincidence of TRAM flaps and prostheses in the setting of breast reconstruction.

It is well known that transverse rectus abdominis myocutaneous (TRAM) flaps can be used to replace unsatisfactory prosthetic breast reconstructions; however, little has been written about the scope of breast implant use in TRAM flap patients. In this study, to ascertain the range of such therapeutic options, their frequency, and their clinical outcomes, the authors retrospectively reviewed the senior author's breast reconstruction experience from 1989 to 2000 with patients in whom both a TRAM flap and an implant were used for breast reconstruction. The authors examined the surgical indications, body habitus, bra size, chest wall irradiation history, flap type, implant type, complications, and outcomes for those patients with TRAM flap and breast implant combinations.Thirty-two women who had 50 (various) combinations of a TRAM flap and a breast implant were identified. There were more clinical scenarios than patients because many of the women had multiple scenarios. The 50 combination scenarios were then divided into six groups. Group I consisted of 14 patients who had elective prostheses placed beneath simultaneous TRAM flaps; group II consisted of 10 patients who had TRAM flaps with contralateral prosthetic reconstruction (in which two implants were received before the TRAM flaps, five implants were received simultaneously with the TRAM flaps, and three implants were received after the TRAM flaps); group III consisted of eight patients who had contralateral augmentation in addition to their TRAM flaps; group IV consisted of 11 patients who had TRAM flaps that were used to cover or replace previous prosthetic reconstructions; group V consisted of four patients in whom prostheses were used to augment or improve previous TRAM flap reconstructions; and group VI consisted of three patients who required prostheses to either reconstruct or salvage total or near-total TRAM flap failures. A broad range of implant types was used, although anatomic saline implants predominated. Forty-one percent of the patients in the review had undergone irradiation during the course of their treatment for breast cancer. Eight of the 32 patients experienced a total of twelve complications, four of which were related to the implants and eight of which involved the TRAM flaps and abdominal donor sites.Although complex, the wide variety of potential TRAM flap/breast implant combinations can be useful for patients with challenging reconstructive scenarios, particularly those that involve radiation therapy. In the group of patients reviewed by the authors, TRAM flaps were most often used in successful partnership either on the same side as or opposite to an implant reconstruction. A TRAM flap was used to salvage or replace an unsatisfactory implant reconstruction in less than a third of the patients. From a risk point of view, implants used opposite a TRAM flap reconstruction had a lower incidence of complication than did implants used beneath TRAM flaps.

Adult↗

Immediate loading of implant-fixed mandibular prostheses: a prospective 18-month follow-up clinical study--preliminary report.

A prospective study was conducted on 13 consecutive patients who received immediately loaded mandibular fixed-implant prostheses. The exclusion criteria were 1) general: heavy smoking, demonstrated bruxism, or general ill health and 2) local: lesions in the bone area to be implanted or inadequate morphology requiring augmentation techniques. After suturing the surgical wounds, impressions were taken, and transitional prostheses were screwed in within 2 weeks of surgery. A total of 61 implants of four different designs were placed. Thirty-two of the implants were placed at the same time as performing the extractions of the residual dentition. In 13 of the implants, there was a 2-month period between extraction surgery and implantation. The other 16 implants were inserted in alveolar bone that had been edentulous for more than 12 months. Despite these differences, all 61 implants were immediately loaded. Parallel x-rays were taken of the 13 patients at the time of transitional prosthesis placement, at the time of definite prosthesis placement, and 6 months later at the first control. During the 18-month follow-up period, two implants failed, and the remaining 59 implants were found to be clinically immobile, asymptomatic, and free of any radiolucency, giving a survival rate of 96.7%. Analysis of radiographic bone levels gives us a cumulative success rate of 93.4%. These figures are comparable to those obtained in similar studies and are no different than those from implant prostheses loaded in the conventional delayed manner. Based on these preliminary results, we can conclude that the immediate loading of mandibular implants is a viable and efficient approach.

Dental Implantation, Endosseous↗

Vibratory sample magnetometry of middle ear prostheses and manufacturing materials.

OBJECTIVE: To assess the magnetic properties of stapes prostheses and manufacturing materials using a vibratory sample magnetometer (VSM). DATA SOURCES: VSM was performed on 16 samples, including ferromagnetic 420F stainless steel, with an LDJ Model 9600 VSM in accordance with American Society for Testing and Materials standard A894. RESULTS: A VSM measures the magnetic dipole moment of a sample in a magnetic field. The magnetic field is swept over a range of magnetic fields, and the magnetic dipole moment is plotted as a function of field. The prostheses made of 316L stainless steel previously found to be ferromagnetic had the highest specific magnetic moments. The specific magnetic moments ranged from 0.023 electromagnetic units (emu)/g to 156 emu/g. The samples made with 316L stainless steel, which is used in otologic implants, were significantly less magnetic than was the 420F stainless steel. CONCLUSION: VSM demonstrates that prostheses made with 316L stainless steel are relatively nonferromagnetic compared with 420F stainless steel. However, none of the implants are nonmagnetic. The torque and linear force on the prosthesis is a concern. The safety of performing MRI on patients with these implants needs to be further assessed.

Electromagnetic Fields↗

Open Tübingen titanium prostheses for ossiculoplasty: a prospective clinical trial.

OBJECTIVE: The overall purpose of the study was the evaluation of the efficacy of Tübingen titanium prostheses (TTPs) for ossiculoplasty. STUDY DESIGN: A two-part clinical study of 216 patients undergoing ossiculoplasty was performed. The first part was a prospective study using TTPs (n = 114). The second part involved study of historical control patients (n = 102) with gold and ceramic prostheses. INTERVENTIONS: All patients underwent ossiculoplasty. MAIN OUTCOME MEASURES: Measures included median air conduction thresholds and air-bone gaps. RESULTS: All patients were per-protocol patients. When the air-bone gap "gold standard" (i.e., < or =10 dB) was investigated in the main speech spectrum, partial TTPs reached this level at 2 kHz in 44% (n = 22) and at 3 kHz in 38% (n = 19). Gold and ceramics revealed significantly lower values. Similar results were obtained for total prostheses. Differences for TTPs and ceramics were statistically significant (Mann-Whitney U test, alpha = 5%). CONCLUSION: The use of TTPs for ossiculoplasty is an efficient treatment method.

Acoustic Stimulation↗

Stapes surgery: how precisely do different prostheses attach to the long process of the incus with different instruments and different surgeons?

HYPOTHESIS: The goal of this study was to compare the attachment of stapes prostheses with differently shaped loops to the long process of the incus. BACKGROUND: In stapes surgery, the attachment of the prosthesis to the long process of the incus plays an important role concerning the gain in hearing and the development of late complications such as incus erosion and necrosis. Band-shaped and spiral loops have been developed to achieve a broad, firm attachment to the long process of the incus. During stapes surgery, the view at the prosthesis is restricted, making it impossible to evaluate the effects of the differently shaped loops. METHODS: Gold, steel/Teflon, platinum/Teflon, and two different titanium stapes prostheses were inserted in 30 specially prepared temporal bones by three experienced surgeons using the Fisch technique with the McGee and straight alligator forceps for the crimping of the loops. Photographs were taken with 0- and 70-degree rod lens telescopes at defined views. RESULTS: In all prostheses, a sufficiently firm attachment to the long process of the incus was achieved. The attachment of band-shaped loops proved to be better with the straight alligator forceps. The band-shaped loops showed a better contact with the incus than did the wire loops. However, the broad spiral-shaped loops led to a loss of the perpendicular axis of the piston to the long incus process. CONCLUSION: The geometry of the loop affects the final length of the piston in the vestibule and its angle to the long process of the incus.

Equipment Design↗

Limitations of titanium dioxide and aluminum oxide as ossicular replacement materials: an evaluation of the effects of porosity on ceramic prostheses.

BACKGROUND: Because the performance of titanium dioxide (TiO2) has not yet been assessed in the unique environment of the middle ear, its role as an ossicular replacement prototype in the form of a total ossicular replacement prosthesis (TORP) was tested and compared with aluminum oxide (Al2O3), once considered to be a suitable implant material. METHODS: Ossiculoplasty was performed by implanting TORPs into the tympanic cavities of rabbits. After an implantation period of 28, 84, or 300 days, the petrous bones were extracted, whereby the biocompatibility of the prostheses was examined using light microscopy and scanning electron microscopy to determine morphologic changes in situ. Proper implant placement and functionality was tested via manual manipulation. RESULTS: Mucosa was seen covering most of the implants by day 84. Inflammatory cells were not observed in any of the specimens examined. The macroporous TiO2 TORPs were subjected to osseous infiltration, material dissolution, and fragmentation, whereas the microporous TiO2 implants were subjected to an increasing frequency of fissure formations. The Al2O3 prostheses demonstrated signs of material dissolution by producing encapsulated aggregates during the experimental trial period. CONCLUSIONS: Neither the macroporous nor microporous oxide ceramics were able to withstand the oscillatory stress to which they were continually subjected. Although porosity allows for the rapid integration of an implant material into a biological environment, its properties are not suited to fulfill the requirements of strength and long-term stability, which are demanded of middle ear prostheses.

Aluminum Oxide↗