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[Macroscopic, histologic and ultrastructural study of 89 prostheses of anterior cruciate ligament excised because of prosthesis failure].

PURPOSE OF THE STUDY: This study concerns the etiology of failed synthetic anterior cruciate ligament (ACL) prostheses, and attempts to identify the primary mechanisms that lead to their premature rupture. MATERIAL AND METHODS: A total of 89 failed and surgically excised ACL prostheses were retrieved from young and active patients (27 +/- 7 years) at various orthopaedic centres in France. Their average duration of implantation was 34 +/- 24 months. They were examined macroscopically, histologically and by scanning electron microscopy (SEM) to determine the model, the manufacturer, the surgical technique used at implantation, the extent of healing, the site of rupture, as well as the morphology of the damage fibers. RESULTS: Seventy two of these explants represented 6 different models. While all 6 were fabricated from polyester fibres, each had a different textile construction, and each were associated with a unique healing and mechanical response in vivo. SEM observations confirmed that abrasion of the textile fibres were a phenomenon common to all models, and were the primary cause of prosthesis failure. Such wear zones were particularly prevalent at the exit of the tibial tunnel and around the femoral condyle. Collagenic infiltration into the synthetic ACL was poorly organized and unpredictable. It did not increase with the duration of implantation. In fact in certain models, it appeared to have caused deterioration and fraying of the textile structure rather than serving as a reinforcing matrix around the prosthesis. DISCUSSION: A synthetic ACL prosthesis is to be preferred for patients who do not have tissue available for autologous ligamentoplasty. Yet none of the synthetic devices examined in the present study were capable of stabilizing the knee over the long term. Among the factors that influenced their failure we found that the three most common mechanisms were flat abrasion against an osseous surface, flexural and rotational fatigue of the fibres, and loss of integrity of the textile structure due to unpredictable tissue infiltration during healing. CONCLUSION: The results of the present study show that none of the current models succeed in replacing the natural ACL. Future improvements may be achieved by developing surgical procedures for implantation combined with a prosthesis made from fibres and textile structures which are more abrasion resistant and promote predictable and controlled tissue infiltration.

Adult↗

[WIll there ever exist the ideal auditive prosthesis for the reconstructive surgery of the middle ear?].

The AA. of the paper review the several materials used for the reconstruction of the middle ear ossicular chain. They inform about each material, including the auto- and homologous grafts of ossicles, cortical bone and cartilage. Palavit, Polyethylene-90, Teflon, metallic implants. Porous plastic materials: Proplast, Plastipore and Polycel. Bioactive ceramic prosthesis (ceramics of aluminium oxyde): Frialit and CORP. Bioactive vitroceramic prosthesis: Macor, Bioglass and Ceravital. Also bioactive of phosphate of calcium: Hydroxyapatite and Apaceram. Prosthesic material of nacre, coal-coal and Polymetacrylate (Ossiculoplast). The most important matter is to get an ear in the best conditions in order to accept the prosthesis, that is to say, a bed completely dry with no inflammatory clues in the tympanic cleft and with a correct functionalism of the Eustachian tube. The healthy ossicular rennants of the chain must be spared. The apatites, bioactive ceramica, are the prosthesis of the future owing to its similitude to the bone. Nevertheless will be difficult to obtain an absolutely inert material inside the middle ear, of the stability of the cleft is not secured.

Ceramics↗

[Influence of the tibial slope on tibial translation and mobility of non-constrained total knee prosthesis].

PURPOSE OF THE STUDY: We determined retrospectively the influence of posterior tibial slope and anterior cruciate ligament (ACL) sparing on anterior tibial translation in 68 Cloutier total knee prosthesis. We also precised the influence of posterior tibial slope on knee functional score and appearance of tibial prosthetic interfaces. MATERIAL: 38 Cloutier total knee prosthesis (62 patients mean aged 62 +/- 10 years (36-76) at surgery) reviewed at systematic follow-up control, after a mean period of 5.5 +/- 3 years (2-15), were included in the study. The ACL was preserved in 38 knees and sacrified in 30 knees, the posterior cruciate ligament was preserved in all cases. The prosthetic design was the same whatever the number of cruciate ligament preserved. Osteoarthritis was the reason for surgery in 54 knees, and rheumatoid arthritis in 14 knees. Mean HSS knee score was 54 +/- 10 (29-80) before surgery and 89 +/- 10 (35-100) at follow-up. The mean range of motion was 103 +/- 24 degrees (30-130) before surgery and 110 +/- 14 degrees at follow-up (40-130). METHODS: Anterior tibial translation was determined on two profil x-rays (non weight bearing and weight bearing) at 20 degrees of flexion by comparing the position of tibial tray with regard to posterior edge of femoral prosthesis. Tibial slope was measured on lateral view with regard to peroneus axis. Appearance of tibial prosthetic interface was studied in 48 knees on AP and lateral x-rays orientated with an image intensifier in order to obtain the x-ray would be parallel to the tibial interface. RESULTS: Posterior tibial slope (mean value 6.2 degrees +/- 4.2 degrees) was the main factor influencing the anterior tibial translation (mean value 3.9 +/- 4.6 mm) (p = 0.0007). A 10 degree increase of posterior tibial slope makes the anterior tibial translation rise by 5.6 mm in weight bearing situation. When ACL was preserved, the anterior tibial translation was lower but the decrease was not significant. Likewise, preservation of ACL or the degree of posterior tibial slope had no influence on: 1) HSS knee functional score, 2) range of motion. Radiolucent lines were observed in 18 out of 48 knees, but their occurrence was not influenced by the degree of posterior tibial slope or preservation of ACL. DISCUSSION: Posterior tibial slope has a higher influence than ACL preservation on anterior tibial translation. The increase of posterior tibial slope in order to improve range of motion and to protect the bone-prosthetic tibial interface appeared unjustified with this non-constrained prosthesis. Moreover, implantation of tibial tray (whatever the preservation of ACL) with an important posterior inclination exposes to high anterior tibial translation in weight bearing situation. This last condition could reduce the survivorship of tibial polyethylene.

Adult↗

Mitral valve replacement: long-term evaluation of prosthesis-related mortality and morbidity.

Over a 12-year period isolated mitral valve replacement (MVR) was performed in 897 patients including 49 Starr-Edwards no. 6000, 519 SE no. 6120, 115 aortic allograft, and 214 porcine xenograft valves. Mortality and morbidity specifically related to the prosthesis was determined for each valve type. Fifty-two of 505 (10%) discharged patients with SE valves, four of 108 (3.7%) with homografts, no patients with heterografts, died of valve-related causes (P less than 0.05). Actuarial analysis shows continued time-related risk with any valve for both thromboemboli and valve failure. Thromboemboli were much more frequent with SE than with either tissue valve (P less than 0.05). Primary valvular incompetence was more common as a cause of valve failure with tissue valves (P less than 0.05), whereas multiple embolic episodes were more often a cause of valve failure with SE (P less than 0.05). Five of 49 (10%) patients with SE no. 6000, 30 of 519 (5.8%) with SE no. 6120, 19 of 115 (16.5%) with allografts, and two of 214 (0.9%) with xenografts needed reoperation for valve failure. For SE, homograft, and heterograft valves, actuarially determined composite, prosthesis-related mortality show 14% (80/568), 7% (8/115), 0% patients dead 6 years after MVR, respectively (P less than 0.05), while 3 years after MVR, 65% (369/568), 37% (42/115), and 85% (181/214) patients were free of prosthesis-related death or complications, respectively (P less than 0.05). Specific prosthesis-related complications differ between valve types significantly affecting survival and morbidity post-MVR.

Adult↗

The 20 mm Medtronic Hall prosthesis in the small aortic root.

BACKGROUND AND AIMS OF THE STUDY: The choice of prosthesis becomes crucial in the narrow aortic annulus. The 20 mm Medtronic Hall valve has a reduced sewing ring that fits in an annulus where only a 19 mm valve would fit. This study assesses the hemodynamic performance of this prosthesis at rest and at exercise, and compares it with two 19 mm mechanical prostheses. MATERIALS AND METHODS: Forty-two patients were studied by Doppler echocardiography, a mean of 34 months following surgery. Twenty-six had a 19 mm prosthesis implanted (12 standard St. Jude Medical and 14 Monostrut valves) and 16 had a 20 mm Medtronic Hall. Parameters studied were peak velocity and transvalvular gradient, both at rest and at exercise, effective orifice area and valve index. RESULTS: No differences were found between the two 19 mm valves, but when compared with the Medtronic Hall valve at rest, this valve showed significantly lower peak velocity and gradient (2.9 vs. 3.3 m/sec, p < 0.01, and 17 vs. 23 mmHg, p < 0.003, respectively) and higher effective orifice area and valve index (1.3 vs. 1.0 cm2, p < 0.01 and 0.81 vs. 0.62 cm2, p < 0.006, respectively). There were also significant differences under exercise. CONCLUSIONS: The 20 mm Medtronic Hall prosthesis shows a significantly better hemodynamic performance, both at rest and under exercise, than other, 19 mm mechanical prostheses and represents a superior choice in valve replacement with a small aortic root.

Aged↗

Endoscopic treatment of oesophagoairway fistula with oesophageal balloon prosthesis.

OBJECTIVE: To describe our experience with a cuffed oesophageal prosthesis in the management of malignant oesophagoairway fistulas. DESIGN: Retrospective study. SETTING: Teaching hospital, Denmark. SUBJECTS: Nine patients treated with a balloon cuffed oesophageal prosthesis during the period 1987-93. MAIN OUTCOME MEASURES: Endoscopic assessment of the fistula compared with the results and complications of treatment. RESULTS: The prosthesis were inserted without complications. Eight patients had total relief of aspiration and were able to eat a semisolid diet. Three patients needed reintervention. Patients with little or no stenosis of the tumour seemed to be at considerable risk of dislodgement of the tube and those with large fistulas developed protrusion of the balloon into the tracheal lumen. CONCLUSION: Intubation with the cuffed oesophageal prosthesis is safe and relatively inexpensive. Other treatments should be considered in patients with minor stenosis of the tumour or a large fistula.

Adult↗

[Early and late results of St. Jude Medical prosthesis in aortic and mitral portion].

January, 1980 to December, 1988, 118 patients underwent aortic (AVR) (45), mitral (MVR) (55), aortic and mitral (DVR) (21) valve replacement with a tilting disc valve prosthesis, the St. Jude Medical. Age ranged from 11 to 69 years (mean 49). There were seven death within thirty days after the surgery (AVR 1, MVR 5, DVR 1). Follow-up is complete and ranges from 1 month to 107 months (total 392, 4 patient-year (pt-yr), AVR 127.7 pt-yr, MVR 182.6 pt-yr, DVR 82.0 pt-yr). In the AVR group, three late deaths have occurred and actuarial survival at 8 years is 89 +/- 5%. Five patients have sustained thromboembolic episodes from linearized rate of 4.7%/patients-year, and the probability of remaining free of thromboembolism at 8 years is 83 +/- 7% in survivors longer than thirty days after the surgery. In the MVR group, one late death has occurred and actuarial survival at 8 years is 87 +/- 5%. Two patients have sustained thromboembolic episodes from linearized rate of 1.1%/patient-years, and the probability of remaining free of thromboembolism at 8 years is 86 +/- 1% in survivors longer than thirty days after the surgery. In the DVR group, four late deaths have occurred and actuarial survival at 8 years is 75 +/- 12%. Two patients have sustained thromboembolic episodes from linearized rate of 2.4%/patients-year, and the probability of remaining free of thromboembolism at 8 years is 85 +/- 5% in survivors longer than thirty days after the surgery. There is no significance of actuarial survival rate among three groups, but the rate of thromboembolism in AVR group is significantly higher than in other MVR and DVR groups in the first 20 months. Reoperation was carried out in one patient because of perivalvular leak. There have been no thromboses of the SJM valve and no mechanical valve failure. Because of this experience, The St. Jude Medical heart valve prosthesis is our prosthesis of choice for any patient undergoing valve replacement with a mechanical prosthesis.

Adolescent↗

Problems in wearing external prosthesis after mastectomy and patient's desire for breast reconstruction.

BACKGROUND AND AIMS: To evaluate the inconvenience caused by an external prosthesis and the desire for breast reconstruction among Finnish breast cancer patients. MATERIAL AND METHODS: A questionnaire was sent to 345 mastectomized women 2-58 months after surgery between 1989 and 1993; 176 questionnaires were eliglible for review. Response rate was 63%. RESULTS: Mean age of the patients was 58 years, and 91% wore an external prosthesis. Of the patients under 65 years old, 46% wished to have reconstruction, but only one patient in the group 65 years old or older was interested in reconstructive surgery. In this study, interest in reconstructive surgery did not decrease with time. Younger patients had more difficulties and inconvenience with the prosthesis in every-day life while working, enjoying leisure time pursuits and wearing clothing. CONCLUSIONS: Breast cancer patients under 65 years have considerable problems with external prosthesis in every-day life. This is the group of patients therefore, that should be considered when evaluating the need for breast reconstruction in the community. Of new breast cancer patients in Finland, 40% per cent are between 45 and 59; about 50-70% of them will have a mastectomy. Our study suggests that breast reconstruction is needed for about half of these patients. Therefore, the annual need for breast reconstruction in Finland involves about 370 women.

Adult↗

[Role of the process of endothelium formation on the wall of the aortic prosthesis in protection against infection. Experimental study in dogs].

An experimental canine model was developed in order to evaluate the role of endothelialization of aortic prostheses for protection against septicemic infection and the utilization of 131I radiolabeled bacteria for vascular experimentation. Two groups of dogs were submitted to insertion of a dacron prosthesis segment in the abdominal aorta with subsequent infusion of inert 131I radiolabeled bacteria. In the first group ("A"), formed by five dogs, the infusion was made 30 minutes after the insertion of the prosthesis and in the second group ("B"), formed by four dogs, in a new surgery performed 12 weeks after. Fragments of the animals' prostheses and aortas were collected after 30 minutes of septicemia and analyzed by scan electron microscopy and submitted to reading of radioactivity uptake by a well-type counter. The microscopy recognized a complete endothelialization of the prostheses of dogs of group "B" 12 weeks after their insertion. Statistical analysis comparing fragments of non-endothelialized prostheses, of endothelialized prostheses and aortas demonstrated that the lower radioactivity uptake of the endothelialized prostheses in relation to non-endothelialized ones was significant (p = 0.0143) and that there was no significant statistical difference in uptake in the aortas and in endothelialized prosthesis (p = 0.3173). It was, therefore, concluded that prosthesis endothelialization fully protected them against septicemic infection; bacteremia contaminated all the non-endothelialized prostheses; there was no bacterial adhesion in the endothelialized prostheses and the use of bacteria labeled with radioisotope 131I is appropriate for the study of infections in vascular prosthetic devices.

Animals↗

[Radiologic changes following cement-free implantation of hip prostheses. 5-year follow-up and clinical experience with the cement-free hip prosthesis Autophor-900-S].

PURPOSE: To evaluate early reliable radiographic signs of loosening in cementless total hip arthroplasty compared to clinical follow-up. METHODS: Within a time interval of 5 years 89 patients with 101 hips underwent total hip arthroplasty using the Autophor 900 S-prosthesis. Clinical and radiographic follow-up were first performed retrospectively followed by a prospective investigation. RESULTS: Radiographic evaluation showed prosthesis fixation in 93%. Loosening of the prosthesis was identified in 4 cases of the acetabular component and in 4 cases of the femoral stem. Pain was associated with radiographically detectable loosening of the cementless arthroplastic components in only two cases. CONCLUSION: Within a follow-up period of up to five years, loosening of cementless total hip arthroplasty occurs in about 7%. The most reliable radiographic signs of loosening are complete radiolucent zones wider than 2 mm at the bone-component interface, progressive subsidence, migration, or tilt of the component. Pain and movement disorders are not specific symptoms and do not necessarily indicate a loosening of the prosthesis.

Adult↗

[Surgical treatment of aortic stenosis: which prosthesis for which patient?].

The long-term evolution following aortic valve replacement depends on the specific clinical context for each patient, but also on the type of prosthesis used. The increased hemorrhagic risk with mechanical prosthesis has to be weighed against the long-term risk of structural failure of bioprostheses. The patient's age will be a key determinant in the choice of the best suited prosthesis. Usually, bioprostheses are preferred after 70 years of age, while mechanical prostheses are chosen in patients under 65.

Age Factors↗

Introduction of a flexible polymeric heart valve prosthesis with special design for aortic position.

OBJECTIVE: Current prosthetic heart valves necessitate permanent anticoagulation or have limited durability and impaired hemodynamic performance compared to natural valves. Recently a polymeric valve prostheses with special design for mitral position demonstrated excellent in vitro and in vivo results with improved durability and no need for permanent anticoagulation. In this study, a respective flexible polymeric aortic valve is presented and in vitro and in vivo results are reported. METHODS: The aortic prosthesis (ADIAM lifescience AG, Erkelenz, Germany) is entirely made of polycarbonaturethane. The tri-leaflet flexible prosthesis mimicks the natural aortic valve and has a diminished pressure loss and reduced stress and strain peaks at the commissures. The valve underwent long-term in vitro testing and in vivo-testing in a growing calve animal model (20 weeks, 7 aortic valves) and was compared to two different commercial bioprostheses. RESULTS: The polymeric aortic heart valve substitute demonstrated excellent in vitro and in vivo hemodynamics. Five/seven animals with aortic PCU-prostheses had an excellent clinical long-term course. The explanted valves showed a variable degree of calcification. Two of the seven animals died at 27 and 77 days due to pannus overgrowth causing severe LVOTO without degeneration of the valve itself. Both animals with commercial bioprostheses had to be sacrificed because of congestive heart failure related to structural degeneration of the bioprosthesis after 10 and 30 days of implantation. There was no increased thrombogenity of the PCU valves compared to bioprostheses. CONCLUSION: The new flexible polymeric aortic valve prosthesis is superior to current bioprostheses in animal testing.

Animals↗

Patient-prosthesis mismatch does not affect survival following aortic valve replacement.

OBJECTIVE: Patient-prosthesis mismatch (PPM) has been reported to increase perioperative mortality and reduce postoperative survival in patients undergoing aortic valve replacement (AVR). We analysed the effect of PPM at values predicting severe mismatch on survival following AVR in our unit. METHODS: Prospectively collected data on 1481 consecutive patients who had undergone AVR with or without coronary artery revascularisation between 1997 and 2005 were analysed. Projected in vitro valve effective orifice area (EOA) and geometric prosthesis internal orifice area (GOA) were evaluated and values were indexed to body surface area (cm(2)m(-2)). PPM was defined as EOAi<0.6 and/or GOAi<1.1. Long-term survival data were obtained from the National Institute of Statistics. RESULTS: One thousand four hundred and eighteen patients were identified. 67/1418 (4.7%) patients had GOAi<1.1; 122/1418 (8.6%) had EOAi<0.6 and 38 (2.6%) patients exhibited both forms of mismatch. One thousand two hundred and sixty-seven patients (89%) demonstrated no mismatch (reference group). There were 75 in-hospital deaths (overall mortality 5.3%) with no significant difference between the mismatch and the reference groups. Survival data were available for up to 8 years (median 36 months, IQR 6-60 months). There were 160 late deaths (13/143 PPM group vs 147/1198 reference group). The 5-year survival estimate was similar for both groups (83% PPM group; 81% reference group; p=0.47). Cox-hazard analysis identified advanced age as the only predictor of reduced survival (age>80, RR 2.13, 95% CI 1.38-4.586, p=0.004). CONCLUSIONS: Severe patient-prosthesis mismatch was predicted in 4-10% of patients undergoing AVR but this did not affect in-hospital mortality or mid-term survival.

Adult↗

Unexpected durability of Smeloff-Cutter aortic ball valve prosthesis.

We report a case in which replacement of a Smeloff-Cutter aortic ball prosthesis was required 28 years after initial implantation. A 57-year-old woman underwent aortic valve replacement with a 21-mm Smeloff-Cutter ball prosthesis and open mitral commissurotomy for aortic stenosis, aortic regurgitation, and mitral stenosis in 1973. Severe aortic regurgitation occurred in April 2001, and aortic valve reoperation combined with mitral valve replacement was successfully performed. The patient's aortic ball valve was nearly intact with perivalvular leakage probably causing the aortic regurgitation. Our experience documents longer durability for the Smeloff-Cutter prosthesis than has been reported to date.

Aortic Valve↗

Hemodynamic performance and incidence of patient-prosthesis mismatch of the complete supraannular perimount magna bioprosthesis in the aortic position.

BACKGROUND: Complete supraannular placement and smaller stent design allow the implantation of a Perimount Magna bioprosthesis with a larger inner diameter than that of a standard Perimount. This study compares the hemodynamic performance and the incidence of patient-prosthesis mismatch (PPM) of both prostheses. METHODS: 128 patients underwent aortic valve replacement, receiving either a Magna (n = 57) or a standard (n = 71) prosthesis. Inner aortic annulus diameter was measured intraoperatively by a hegar dilator to match echocardiographically obtained results to the annulus diameter instead of matching them to labelled valve size. RESULTS: The Magna was significantly superior with respect to mean pressure gradient and effective orifice area in patients with an annulus diameter of 22-23 mm. In patients with an annulus diameter < 22 mm or > 23 mm, there was a non-significant trend towards superior hemodynamics in the Magna group. Severe PPM (effective orifice area index < or = 0.65 cm (2)/m (2)) was present in 11.1% (Magna) vs. 42.1% (Standard) of patients with an annulus diameter < 22 mm; in 0% (Magna) vs. 13.8% (Standard) with an annulus diameter of 22-23 mm; no PPM was seen in patients with annulus diameter > 23 mm in both groups. CONCLUSIONS: The Perimount Magna had a significantly reduced incidence of patient-prosthesis mismatch and superior hemodynamics compared to the standard Perimount.

Age Factors↗

Pericarbon pericardial valve prosthesis: midterm results of the aortic valve replacement.

This clinical study was undertaken to verify the encouraging results of experimental studies regarding a new pericardial bioprosthesis. From May 1989 to November 1993, 204 patients underwent an aortic valve replacement with the Pericarbon (Sorin Biomedica Cardio S.p.A., Saluggia, Italy) prosthesis. A follow-up was 100% complete and extended to 65 months (total 408 patient-years, average 2.0+/-1.4 years). Mean age at the operation was 75.1+/-5.5 years and 96% were in NYHA clinical stage III or IV. There were 86 men and 118 women; 73 patients had an isolated aortic valve disease, 131 had a concomitant cardiosurgical procedure (coronary artery bypass grafting in 106 patients). The operative mortality (30-day mortality) rate was 11.8% (24/204). There were 24 late deaths (5.9+/-1.2% patient-year). The actuarial probability of survival was 68+/-5% at 5 years. Four patients died of valve-related causes (one thromboembolic complication, two endocarditis, one anticoagulant-related hemorrhage). Actuarial rate of freedom from valve-related death was 95+/-3% at 5 years. Valve-related morbidity included seven thromboembolic episodes (1.7% patient-year), four anticoagulant-related complications (0.9% patient-year), three endocarditis (0.7% patient-year) and one reoperation (0.2% patient-year). After 5 years freedom from thromboembolic events was 83+/-7%, from anticoagulant-related hemorrhage 96+/-2%, from endocarditis 97+/-2%, and from reoperation 99+/-1%. Echocardiographic study performed in 30 patients showed a paraprosthetic leak in four patients, a central leak in two, and cusp thickening in another three. The clinical data showed that the Pericarbon prosthesis has valve-related morbidity. The echocardiographic results suggest that the prosthesis can undergo a pathologic process during the first 5 years after implantation. This makes it necessary to continue the follow-up and include the larger number of patients in the echocardiographic investigation.

Actuarial Analysis↗

Erosion of an inflatable penile prosthesis due to autoinflation.

A 59-year-old man presented with erosion of an inflatable penile prosthesis. The cylinders were not deflated and the right one protruded from the urethra. Autoinflation that causes failure of deflation is an annoying and embarrassing mechanical failure. This failure may cause intraurethral erosion of the prosthesis. Urologists should inform their patients who hope for implantation of an inflatable prosthesis of this potential adverse event prior to surgery.

Humans↗

[Mandibular reconstruction using a metallo-acrylic implant prosthesis in oncology. Apropos of 40 cases].

The authors report on 40 cases using acrylic-metal prosthesis after ablative cancer surgery and compare them with the literature. The long-term complications (prosthesis extrusion or infection) are important, but the short-term follow-up (3 months) is more than 80% of success, any material used. The prosthesis keep a physiological position to the mandible, against scar sequelae. The use of soft tissue closure without post-operative radiotherapy increase the success of a simple-used and low-priced device of mandibular reconstruction.

Acrylic Resins↗