Plasti-pore implants in middle ear surgery

Plasti-pore, a high-density polyethylene sponge, was one of the earliest biocompatible materials developed specifically for implantation in the middle ear. It is one of the most nonreactive materials known when tested in simulated biochemical exposure to pseudoextracellular fluid. The two basic prosthetic designs are the total ossicular replacement prosthesis and the partial ossicular replacement prosthesis. Plasti-pore implants have now been used for 20 years and are widely accepted by otologic surgeons. The basic properties of the material, implant design, and surgical techniques involved using these prostheses are reviewed in this article.     

Successful chemotherapy in a patient with recurrent carcinoma of the urachus

OBJECTIVE: Titanium in other parts of the body, well known for its biocompatibility, was examined in an animal model for its use as an ossicular replacement material. STUDY DESIGN: The biocompatibility of titanium was studied in the middle ear of rabbits using light and scanning electron microscopy. Titanium pins were placed as middle ear prostheses or as free implants and were examined after 28, 84, 168, and 336 days. RESULTS: After 28 days, the prostheses were covered by regular mucosa. The free implants took up to 336 days to be totally epithelialized. There were no inflammatory cells observed on the surface of the material nor were unusual amounts of fibrous tissue seen. In addition, the titanium material exhibited an affinity toward bone. CONCLUSIONS: The results of this animal experiment indicate that titanium is a useful material for ossicular replacement prostheses.     

Titanium as a biomaterial for ossicular replacement: results after implantation in the middle ear of the rabbit

The middle ear poses unique challenges when finding suitable materials for ossicular reconstruction, primarily because of its link to the external environment via the eustachian tube and, hence, its greater exposure to infectious agents. In this study, the biocompatability of titanium was examined in the middle ear of rabbits by using light and scanning electron microscopy. Implants were placed as middle ear prostheses or as free implants. These were inspected at 28 days, 84 days, 168 days, 336 days and 504 days following implantation for mucosal coverage, percent epithelization and any sign of foreign-body reaction. After 28 days, the prostheses were covered by regular mucosa. Although a majority of the free implants took up to 336 days for complete epithelialization, some of the free implants were not epithelialized even at day 504. There were no inflammatory cells observed on the surface of the material, nor were unusual amounts of fibrous tissue seen. In addition, the titanium material exhibited an affinity toward bone. The results of this animal experiment indicate that titanium is a favorable material for ossicular replacement prostheses.     

Incus homografts (author's transl)

The problem of reconstruction of the ossicular chain is still partly unsolved. A possible way of solving this problem is with a homograft in cases with total or partial ossicular chain defect. The method of preparing the homografts in our Clinic is described. The formation of an ossicular bank is quite easy, the procedure for preparing adequate implants simple and safe. This is a preliminary report concerning patients under review from 3--24 months, on whom the described method was used.     

Adjusting the geometry of implantable hearing aid components to human temporal bone. II: Microphone

Prerequisite to implantation of a piezoelectrical transducer of an implantable hearing aid is a shape allowing its implantation into human mastoid and middle ear. To approach this problem, a consecutive series of six transducer prototypes was created in an iterative process. Their functional geometry was evaluated in 50 human temporal bones. A shape for a functioning transducer was found which will enable implantation in 78% of the cases examined (confidence interval: 61.5%-89.2%). It will allow simultaneous implantation of the transducer into the mastoid and microphone, which is situated transmastoidal in the posterior wall of the ear canal. Furthermore, the transducer may be coupled to the ossicular chain or the perilymph.     

Decalcified, lyophilized, sterile heterotopic porcine ossicular xenografts. Experimental evaluation in the guinea pig

Using the guinea pig middle ear model, we assessed decalcified, lyophylized, sterile heterotopic porcine ossicular xeno-implants based on a histology (optic and electron scan microscope) and immunologic (immunofluorscence) methods. Implants were placed in the middle ear and others in the dorsal subcutaneous area. Allo-implants were compared as controls. Implants were placed in the middle ear in 54 animals and skin implants in 14. Under the influence of BMP, the implant ossified in all cases in the middle ear. Intense immune recruitment was not observed. Inversely, there was a mononuclear infiltration reaction to the skin implants with formation of a fibrous capsule, immunoglobulin and complement influx and consequently sequestration. The allo-implants were partially reossified. These findings confirm the value of decalcification with hydrochloric acid for BMP induction, independent of species and the failure of attempted immune despecification. Implant outcome is not dependent on its antigen load, which is high compared with its weight, but on the site of implantation. The middle ear appears to be a privileged site of implantation.     

Proplast implants used in otology and in facial reconstructive surgery

Proplast, a self-stabilising alloplastic material, was evaluated in ear surgery and in facial reconstructive surgery. Proplast implants were used on 33 patients to reconstruct the ossicular chain (total or partial ossicular replacement prosthesis), or to rebuild the mastoid cavity. The lack of extrusion over a 24-month period is encouraging. In facial reconstructive surgery 11 patients received Proplast implants to augment and restore facial contours. Contamination with saliva remains a problem, owing to the high porosity of Proplast, which could harbour infection. When Proplast was sterile when implanted, no extrusion appeared over a 12-month period. Although the patients presented here were followed up for a relatively short time, they provide reason for some optimism that the vexed question of alloplastics applied in the field of ear, nose and throat surgery may be solved.     

Hypnotic susceptibility order effects in waking analgesia

OBJECTIVE: To develop a measuring apparatus that has the ability to sweep both frequency and external auditory meatus static pressure and can display measurement results in a three-dimensional expression. To measure the middle ear dynamic characteristics of normal-hearing subjects and of patients with this apparatus. DESIGN: Investigate 275 ears of 153 normal-hearing subjects and 72 ears with middle ear diseases. RESULTS: The measurement results show fairly distinctive patterns depending on the middle ear conditions, i.e., normal, ossicular chain separation, ossicular chain fixation, secretory otitis media, tympanic membrane perforation, and tympanic membrane atelectasis. The evaluation of patients with ossicular diseases revealed that the rate of correct diagnosis of ossicular chain separation is 84% and that of ossicular chain fixation is 74%. These diagnoses were confirmed by surgery. CONCLUSION: Displaying the measurement results in a three-dimensional expression is helpful to make correct diagnosis in clinical practice. It is especially easy to make a distinction between the ossicular chain separation and ossicular chain fixation. Therefore, it is concluded that this apparatus has a high degree of clinical applicability to the diagnosis of these diseases.     

Indications for middle ear obliteration within the scope of cochlear implant management

BACKGROUND: Cochlear implants have gained worldwide acceptance as a reliable method of rehabilitation of profoundly hearing-impaired patients. Due to thorough patient selection major postoperative complications rarely occur and are flap related in most cases. Deafness can develop during chronic suppurative otitis media, either coincidentally or secondary to the medical treatment; normally this condition is regarded as a contraindication for cochlear implantation. In cases with a mastoid cavity after surgical treatment for cholesteatoma, the electrode covered only by the epithelial lining will likely become exposed or extruded. Therefore we suggest the obliteration of the middle ear cleft with abdominal fat and the blindsac closure of the external ear canal before cochlear implantation in these conditions. PATIENTS: The average age of our 12 patients was 48 years, whereas the youngest was 2 1/2 years of age. Due to chronic inflammatory ear disease. 11 patients had a mastoid cavity on both ears. Eight patients had a cholesteatoma, the chronic bone destroying process in the temporal bone of two female patients was considered as a fibroinflammatory pseudotumor. The child had a congenital deafness in both ears with a Mondini dysplasia in CT scan. She had already developed two episodes of pneumococcal meningitis which was caused by a defect in the stapes footplate through which a liquor-filled cystic sac herniated in the middle ear. Because of a massive liquorrhoea after opening of the sac, we decided to obliterate the middle ear cleft after successful insertion of the electrode array. RESULTS: All active electrodes of 10 Nucleus implants (Cochlear) and two Clarion devices (Advanced Bionics Corp.) were successfully inserted in the cochlea of the 12 patients. After an average follow-up of 15 months, a temporary facial palsy in one patient and an insufficient closure of a retroauricular fistula over the mastoid cavity in two cases were observed as postoperative complications. One patient with a fibroinflammatory pseudotumor developed a massive inflammatory reaction in the implanted ear two months after cochlear implantation, which could not be controlled by conservative treatment. The implant had to be removed and local conditions settled after administration of immunosuppressive treatment with cyclophosphamide. The patient received a new implant seven months ago. CONCLUSIONS: Implantation of a foreign body in a potentially infected space which communicates intracranially means a surgical challenge which can be managed by obliteration of the middle ear after subtotal petrosectomy with abdominal wall fat combined with a reliable closure of the external ear canal. In case of massive inflammation we would prefer a two-stage procedure.     

Bladder cancer in a patient on long-term haemodialysis

OBJECTIVE: The results of the first cohort of 60 cavity reconstructions with hydroxyapatite with a minimum follow-up period of 15 years were studied. STUDY DESIGN: The study design was a retrospective study. PATIENTS: A total of 60 patients had a follow-up period of >15 years. In four patients, not all data were available. Therefore, 56 patients were included in the study. They had a combination of cavity problems and hearing loss. INTERVENTION: The ear canal was reconstructed with a canal wall prosthesis of porous hydroxyapatite. The ossicular chain was reconstructed with an incus or incus-stapes prosthesis of dense hydroxyapatite. RESULTS: After 15 years, 42 patients (75%) had an intact reconstructed ear canal. The main problem for failure was the recurrent purulent middle ear infection and not cholesteatoma. The histology of the retrieved canal wall showed a good remodeling in living bone tissue. After 15 years, 34 patients had a normal ear canal and an ossicular chain. Of these patients, 7.05% had an air-bone gap closure within 20 dB. CONCLUSIONS: Long-term results of cavity reconstruction with hydroxyapatite are possible. The main problem is recurrent mucosal disease of the new middle ear-mastoid cleft.     

Tissue reactions to glass ceramics in the middle ear

The bioactive glass ceramic "Ceravital" was used to fashion prostheses for the replacement of various ossicles in the middle ear. They were tested in 70 rabbit ears, where they were accepted in osseous areas without formation of surrounding fibrous tissue. Histological examinations regularly showed an osseous bond with the surrounding bony tissue. Mucous membrane covered these ossicular chain prostheses and showed no evidence of inflammatory reactions. Glass ceramic implants were also used to reconstruct the ossicular chain and the posterior wall of the outer ear canal in 100 patients. The functional results were satisfactory in all cases.     

Immunodiffusion and immunohistochemical investigations on the reactivity of oxide ceramic middle-ear implants

Oxide ceramic materials (partial and total ossicular replacement prostheses) have been implants of preference for the reconstruction of the ossicular chain because of their excellent biocompatibility. The reaction on the surface of the implants takes place at three biodynamic levels according to the model of Stern's bilayer. We investigated the adsorption of proteins, which is determined by the cellular reaction and degradation to the surface using radial immunodiffusion and immunohistochemical methods. First, ceramic implants of aluminum oxide, hydroxyapatite, glass ceramic and zirconium oxide have individual actual (i.e. biological) surfaces. With a perthometer and the contact-free laser Focodyn method we determined each actual (i.e. biological) surface of the various ceramic implants mentioned above. Using radial immunodiffusion, the adsorption of albumin, glycoprotein, plasminogen, fibronectin, IgA, IgG and IgM shows characteristic rates of adsorption to the respective ceramic surfaces in correlating to the actual surface. A cross-check with fluorescent antibodies confirmed the protein adsorption. The individual surface adsorption of the proteins remains characteristic and is the basis for the recording of cellular reactions after implantation.     

Tragus perichondrium-cartilage island transplant in middle ear surgery. Method and results after 5 years

Temporalis fascia remains the most widespread material for reconstructing the tympanic membrane in tympanomastoid surgery. If total or partial ossicular replacement prostheses are needed or pathology of the eustachian tube causes ventilation impairment, a more rigid transplant material is required. Between 1989 and 1994 perichondrium-cartilage composite grafts were used in a series of 597 cases of tympanomastoid surgery performed at the University ENT Clinic of Würzburg. The graft was taken from the tragus and prepared as a cartilage island with perichondrium attached to one side, the perichondrium-cartilage island transplant (PCI). If reconstruction of the ossicular chain was necessary, glass ionomer cement protheses (IONOS) were used. Closure of the tympanic membrane could be achieved in 90% of all cases. In those cases where ossicular chain reconstruction was postponed to a second procedure, closure of the drum was achieved in 96%. The audiological results of the different type III procedures were evaluated. By using the PCI technique a favorable closure of the air-bone gap to 10-25 dB was achieved, even in cases with advanced ear pathology technique and results are presented in detail.     

Active electronic cochlear implants for middle and inner ear hearing loss--a new era in ear surgery. I: Basic principles and recommendations on nomenclature

Hearing aids have fundamental disadvantages: (1) stigmatization of the patient; (2) the sound is often found to be unsatisfactory due to the limited frequency range and undesired distortion; (3) in many patients, the ear canal fitting device generally necessary leads to an occlusion effect; (4) acoustic feedback when amplification is high. Conventional hearing aids transmit sound into the ear canal via a small microphone. Sound has the disadvantage of requiring high output sound pressure levels for its transmission. This along with the necessary miniaturization of the loudspeaker as well as the resonances and reflections in the closed ear canal contribute to the disadvantages mentioned. In contrast, implantable hearing aids do not make sound signals but micromechanical vibrations. An implantable hearing aid has an electromechanical transducer instead of the loudspeaker of a conventional hearing aid. The hearing signal does not leave the transducer as sound but as a mechanical vibration which is directly coupled to the auditory system bypassing the air. This implantable hearing aid is either coupled to the tympanic membrane, the ossicular chain, the perilymph of the inner ear, or the skull. An implantable hearing aid is expected to have: 1 Better sound fidelity than a hearing aid 2 No ear canal fitting device, free ear canal 3 No feedback 4 Invisibility Requirements on electronic hearing implants designed for patients with conductive hearing loss differ from those on implants for sensorineural hearing loss. Conductive hearing loss requires the implant to replace the impedance transformation, thus being an impedance transformation implant (ITI). In various respects, the demands on an ITI are lower than the demands on an electronic hearing aid for patients with sensorineural hearing loss. The latter are mostly patients with a failure of the cochlea amplifier (CA). A damage to the CA is clinically discernible by a positive recruitment and loss of otoacoustic emissions (OAE). Since these patients form the majority of cases with sensorineural hearing loss, an active hearing implant for such patients should partially replace the function of the CA. Therefore, the suggestion is to refer to a CAI (cochlea amplifier implant). The implant expressions ITI (for patients with conductive hearing loss) and CAI (for patients with sensorineural hearing loss) used in this context allow nomenclatural association with the CI (cochlear implant) for complete inner ear failure as well as with the BSI (brainstem implant) in the case of hearing nerve failure.     

Experimental cranioplasty and skeletal augmentation using an alpha-tricalcium phosphate/dicalcium phosphate dibasic/tetracalcium phosphate monoxide cement: a preliminary short-term experiment in rabbits

Calcium phosphate cement consisting of alpha-tricalcium phosphate (alpha-TCP), dicalcium phosphate dibasic (DCPD) and tetracalcium phosphate monoxide (TeCP) was implanted into surgically created full-thickness defects in the cranial bone (bone defect experiment) and directly onto the cranial bone under the periosteum (augmentation experiment). Three months after the implantation, the implants were retrieved with the surrounding tissues and studied histologically and micrographically to evaluate if the cement can be used as a cranioplasty and skeletal augmentation material. In the bone defect experiment, successful reconstruction of the defect was seen in 8 out of 12 specimens. Four specimens, where bleeding control was difficult at the time of implantation, showed partial loss of the cement. Histological and microradiographic studies of the successfully implanted cement revealed that new bone surrounded the implant nearly completely and united directly with the cement surface. In the augmentation experiment, the augmented area maintained the hemispherical shape and was connected tightly with the host bone. Histology and microradiography demonstrated that new bone formation was seen in the gap between the cement and the host bone, and on the outer surface (periosteum side) of the cement at the edge of the implant. From this preliminary short-term study, it could be concluded that the cement is a promising material for cranioplasty and skeletal augmentation with indications that it has good osteoconductivity.     

Autologous tissue in initial type I and type III tympanoplasty operations in chronic suppurative otitis media

We reviewed 192 patients who had been treated for chronic otitis media. All operations were carried out at the Department of Otolaryngology, University of Tübingen. No patient had a previous ear operation and revision operations were excluded. The observation period varied from a minimum of 1 year to a maximum of 4 1/2 years. The ossicular chain was partially destroyed in 43 ears (22.4%). Ossiculoplasty was performed using autologous ossicles. An inens was used in 31 ears and a malleus in 12 cases. The overall failure rate was 20.8%. Most recurrent perforations were found in middle-aged patients. Children had only a 14% incidence of recurrent perforations. Fascia was the material associated with the highest failure rate (28.6%). After using perichondrium 6.8% of the cases had recurrent perforations, whereas the perichondrium-cartilage transplant was not successful in 4.8%. Overall, 62.7% of the patients were found to have an air-bone gap of 10 dB or less at 1.5 kHz 3-6 months after surgery. An air-bone gap of 20 dB or less was found in 91.2% of the patients. The main problem seen in the patients with chronic otitis media was not reconstruction of the ossicular chain but a lasting closure of the tympanic membrane. The perichondrium-cartilage transplant permitted the best results and is now recommended especially for patients with unfavorable middle ear conditions. A long-lasting closure of the tympanic membrane was also found in children (< or = 15 years of age). For this reason we also recommend an early operation in order to allow children to lead a normal life.     

Implantation of electromagnetic ossicular replacement device

Semi-implantable hearing aids consisting of permanent middle ear implanted magnet, either partial ossicular replacement prostheses (PORP's) or total ossicular replacement prostheses (TORP's) driven by an electromagnet placed in the ear canal have been tested on six patients undergoing surgery for chronic otitis. The surgical and audiological problems are described. The audiological results were excellent in all six cases. A functional gain of 40-70 dB can be obtained for entire frequency range of the audiogram.     

Kinetical analysis of tumor cell death-inducing mechanism by polymorphonuclear leukocyte-derived calprotectin: involvement of protein synthesis and generation of reactive oxygen species in target cells

Nasal reconstruction presents a significant challenge to the facial plastic surgeon. Reestablishment of the desired aesthetic nasal contour and restoration of respiratory function are the dual goals of this endeavor. While autologous cartilage or bone is considered optimal grafting material, the supply is often limited and harvesting entails additional morbidity. Many synthetic materials have been introduced for use in nasal reconstruction, but high infection and extrusion rates have left most surgeons dissatisfied with conventional implants. Porous polyethylene (Medpor) implants were used for nasal reconstruction in 187 patients; 66 (35.3%) patients underwent primary rhinoplasty, while revision surgery was performed in 121 (64.7%) patients. Most patients required multiple implants, including columella struts, plumper grafts, dorsal tip implants, and nasal valve battens. Postoperative follow-up ranged from 6 months to 3.5 years. Complications occurred in five (2.6%) patients. Three early and two delayed infections necessitated implant removal in five patients, all of whom had compromised skin-soft tissue envelopes secondary to heavy smoking, cocaine abuse, or prior surgery. One case of an overly augmented nasal dorsum and tip required implant removal, reduction, and reinsertion. All implants were easily removed. No other complications including implant extrusion or skin erosion have been noted. Porous polyethylene (Medpor) implants allow for fibrovascular ingrowth, which lends stability to the implant. Porous polyethylene implants are well tolerated and provide an ideal material for nasal reconstruction.     

Reconstruction of residual alveolar cleft defects with one-stage mandibular bone grafts and osseointegrated implants

PURPOSE: This study evaluates a treatment regimen for reconstruction of residual maxillary alveolar cleft defects consisting of mandibular bone grafting and immediate implant installation. PATIENTS AND METHODS: Sixteen cleft patients (five female and 11 male) had residual cleft defects of the alveolar ridge reconstructed with bone grafts from the mandibular symphyseal region. The bone graft was pretapped at the donor site before fixation in the residual ridge with Br?nemark implants. Twenty implants were installed according to this concept. The period of observation ranged from 36 to 69 months, with a mean of 48 months after implant installation. RESULTS: Five patients developed wound dehiscenses that resulted in total or partial bone graft sequestration. Two implants were lost, one due to sequestration and the other due to mobility at the abutment procedure; 18 implants were still well functioning at the end of the observation period. However, all patients showed significant periimplant bone resorption after this one-stage treatment. CONCLUSION: Because of the observed complication rate, the one-stage procedure may not be optimal for reconstructing residual cleft defects.     

Evaluation of expanded polytetrafluoroethylene as a soft-tissue filling substance: an analysis of design-related implant behavior using the porcine skin model

Soft-tissue augmentation using the synthetic nonfluid biomaterial expanded polytetrafluoroethylene (ePTFE) has been supported by number of recent reports citing the favorable characteristics of biocompatibility, soft and natural feel, ease of use, and permanent augmentation. Concern has been expressed about this application for ePTFE material because of the proximity of the implants to the skin surface and potential problems with infection and extrusion. We evaluated the behavior of a series of specific ePTFE implant designs using a long-term subcutaneous augmentation model. By using a porcine model, 466 implants of ePTFE in the form of strips, rolls, or tubes were placed using a percutaneous insertion device subcutaneously over the dorsum and face. The animals were divided into three study groups by length of implantation (3 weeks, control; 6 months, intermediate term; and 12 months, long-term) and en-bloc tissue specimens, including skin, implants, and underlying soft tissue, were harvested for gross and histologic examination. Implants were removed at the earliest sign of infection, exposure, or extrusion and the difficulty of removal was ascertained and recorded. These data reveal that ePTFE material elicits acceptable levels of tissue activity with low extrusion rates over the short and long term supporting its use for soft-tissue augmentation. The data show a clear difference, however, in the host response and behavior of the implants for this application based on shape or design. A statistically significant difference in the low, but measurable, extrusion rates was observed amongst these implant designs. ePTFE tubes showed greater stability and predictable augmentation over other implant designs for soft-tissue augmentation and seem to represent a substantial improvement for this application.