------------------------------------------------------------------------------ TITLE: OSSICULAR CHAIN RECONSTRUCTION SOURCE: Dept. of Otolaryngology, UTMB, Grand Rounds DATE: JANUARY 26, 1994 RESIDENT PHYSICIAN: KATHLEEN McDONALD, M.D. FACULTY: JEFF VRABEC, M.D. DATABASE ADMINISTRATOR: Melinda McCracken, M.S. ------------------------------------------------------------------------------ "This material was prepared by resident physicians in partial fulfillment of educational requirements established for the Postgraduate Training Program of the UTMB Department of Otolaryngology/Head and Neck Surgery and was not intended for clinical use in its present form. It was prepared for the purpose of stimulating group discussion in a conference setting. No warranties, either express or implied, are made with respect to its accuracy, completeness, or timeliness. The material does not necessarily reflect the current or past opinions of members of the UTMB faculty and should not be used for purposes of diagnosis or treatment without consulting appropriate literature sources and informed professional opinion." INTRODUCTION: Ossicular chain reconstruction is the rebuilding of the middle ear ossicular chain which has been disrupted or destroyed through the use of some interpositioned device. This is to regain the original mechanics of the ossicular chain and convert this mechanical energy into the electrical impulse produced by the cochlea. There are three main categories of ossicular defects that prevent the transmission of sound pressure across the middle ear: 1. loss of ossicular continuity as with traumatic dislocation, surgical or middle ear pathology such as cholesteatoma; 2. fixation of the ossicles as with otosclerosis or myringostapediopexy; 3. a combination of the two. This paper will go over the different types of prosthesis used, surgical technique and outcome. HISTORY: 1964 -1987 the main reconstructive material was homograft ossicles. At first, the incus body was mearly repositioned on the head of the stapes or stapedial footplate. Over the years the sculpturing of the incus evolved. Two principle types of sculpturing were the notched incus with short process, which was used on an intact stapes, and the notched incus with long process, which was used not only to replace the incus but the stapedial superstructure as well. MECHANICS: The normal incudo-stapedial joint is subject to high stress. This stress is usually easily coped with in the normal ear with its synovial joints and supporting ligaments, but reconstruction introduces new geometry and interfaces. The study by Lesser found that the stress levels at the implant-stapedial joint increases as the prosthesis is gradually moved down the malleus. On the other hand, there is some evidence that there is an increase in sound transmission as the implant is moved down the malleus. Achievement of the piston-like movement of the stapes footplate proved to be the most effective in producing displacement of the vestibular fluids. Ossicular reconstructions which produce tilting of the stapes induce markedly less movement of vestibular fluids. Transmission of lower frequency stimuli is more efficient than for the higher frequencies. In the malleus-stapes assembly reconstructions the position of the prosthesis is critical- the smaller the angle between the resolved components of the applied forces the greater the efficiency of transmission. With the columellar systems the site of contact on the footplate is less critical to the magnitude of transmission, than the tension of the prosthesis. This is seen in the ear where the malleus lies very anteriorly thus unavoidably angulating the prosthesis. It also provides the explanation for the observation that a prosthesis place between the stapes head and the tympanic membrane (providing direct transmission from the TM to the stapes footplate) often produces better results. SYNTHETIC PROSTHESIS: Increased concern about the use of human donor tissue for biological implant led to the search for totally synthetic prosthesis for middle ear reconstruction. This has been the result of increased awareness regarding the use of human banked tissue and the possibility of transmitting acquired immune deficiency syndrome or other infectious diseases. In 1989, a survey of the American Otological Society showed that autograft bone and cartilage, homograft bone and cartilage, and Plasti-Pore PORPs and TORPs (which require a cartilage interface) were the most common types of implants used. Of these nine prosthesis, six required the use of human tissue. Despite no documented case of AIDS virus being transmitted through the use of homograft bone or cartilage the search for totally synthetic prosthesis was undertaken. The synthetic prosthesis should ideally exhibit four basic characteristics. It should be biocompatible, readily available, technically easy to use, and give the most advantageous hearing results possible. Plasti-Pore prosthesis by Smith + Nephew Richards was developed The Plasti-Pore is porous polyethylene which is biocompatible material in the middle ear, except when it touches the tympanic membrane directly. It was commonly used synthetic prosthesis but required homograft or autograft cartilage interface to prevent extrusion. Therefore, in 1986, the Richards Medical Company developed the hydroxylapatite prosthesis. Prior the advent of hydroxyapatite, Plasti-Pore was the most frequently used synthetic material for hearing reconstruction. The hydroxyapatite has characteristics of its bony counterparts and was used in the same fashion with an "incus interposition prosthesis" and "incus-stapes prosthesis." Hydroxylapatite belongs to a family of materials know as calcium phosphate ceramics. These are among the most biocompatible materials available today. Their elemental constituents closely resemble those of the mineral matrix of human bone. Hydroxyapatite displays the same crystal structure as human bone. These two previously mentioned characteristics account for its biocompatibility. Living bone has been found to form a chemical bond to the surface of hydroxyapatite. It is also seen that there is little- to-no biodegradation insitu. Hydroxyapatite can be used directly against the tympanic membrane or tympanic membrane graft without the need for any cartilage or other tissue as an interface, unlike the previous material Plasti-pore which requires cartilage interface. Grote was the first to report the clinical use of hydroxyapatite in middle ear reconstruction, and has reported excellent long-term hearing results. Multiple prosthesis have been developed by Wehrs, Black Applebaum, and Goldenberg to name a few, most of which have found good long term hearing results. Hydroxyapatite has many of the ideal characteristics required to be a good prosthesis. It is extremely biocompatible and exhibits a very low extrusion rate. In a study by Goldenberg with 157 consecutive cases he found a very low extrusion rate for hydroxyapatite 2.6% when compared to Plasti-Pore at 6.5% and the homograft at 0%. With the hydroxyapatite most where seen in revision surgery for cholesteatoma where retraction and atelectatic tympanic membranes were present and still resulted in low extrusion. It is readily available as a biomaterial and may be shaped and molded by the manufacture into appropriate configurations. It exhibits no problem with antigenicity or transmittal of disease. Hearing results are comparable to other prosthesis (68-90% depending on the prosthesis type.) Using the criteria of Brackmann, an audiological successful result was defined as a postoperative air bone gap (residual conductive deficit) of 15 dB or less when a PORP or incus prosthesis was placed or a 25 dB or less closure using a TORP or incus-stapes prosthesis. However, hydroxyapatite is technically difficult to use intraoperatively because it is brittle and shatters easily when drilled or trimmed with a sharp instrument. To get around this Plasti-Pore has been used as the shaft to fit onto the capitulum or footplate and the hydroxyapatite head which comes in contact with the tympanic membrane. Plasti-Pore is easy to trim to desired configuration intraoperatively. Goldenberg initially developed this modification. OUTCOME: Elimination of residual or recurrent disease is the primary prerequisite for ossicular reconstruction. A frequent reason for reconstruction is the destruction of the ossicles from chronic infection and cholesteatoma. This must be eradicated if the reconstruction is to be a success. The surgeon must start by identifying the anatomical, pathological and functional situations involved with the patients ear which will be necessary to pick the proper prosthesis and timing of the surgery. The anatomical factors to consider are the relation of the drum to ossicular remnant, the stapes profile and the angle between stapes and malleus handle. Pathological factors with the type of ossicular defect, the lining of middle ear and function of the eustachian tube all need to be considered. Otologist have lacked a detailed ability to assess the preoperatively the fate of an ossiculoplasty. A study by Black looked into significant adverse clinical features to more accurately evaluate "risk content." It was found that five types of influences may complicate an ossiculoplasty: surgical, prosthetic, infection, tissue, and eustachian (the SPITE factors.) Previously the Otologist had limited methods of comparing the pathologic basis of ossiculoplasty. Those included the Bellucci classification and Austin's ossicular classification. The Bellucci system described the state of infection: 1. never infected; 2. intermittent discharge; 3. unremitting discharge, and 4. cleft palate and nasopharyngeal deformities. The other classification is Austin's ossicular classification which is simple but an effective description of the status of the chain but, does not address the problem of the suitability of the malleus to receive a malleus-to-stapes assembly, or the problem of the fixed footplate. Austin defines four types of ossicular defects depending on the presence or absence of malleus handle and stapedial arch. In SPITE the first area to look at is the surgical skill of the surgeon and the complexity of the case. This spills over into the type of defect present, therefore, the type of prosthesis needed for the different situations can affect hearing outcome. The third area that is looked at by the SPITE criteria is infection such as unremitting otorrhea and it appears to have the highest adverse effect on outcome. Tissue factors influence success. It has been separated into vitality - general health condition of the patient, and dynamics - preoperative mucosal quality. Eustachian tube dysfunction with effusion and atelectatic membranes point towards poor results. The data attained from this will help in the assessment of patients and their likely outcome, but will also allow for comparisons between studies. Results can be improved by awareness of the possibilities for reconstruction and making best use of available prosthesis. The principles applied to improving tympanoplasties can contribute to ossiculoplasty success by preventing atelectasis or lateralization; these include graft placement, grommet insertion, silastic sheeting and staging. One stage procedures should only be attempted in cases with intact tympanic membranes or intact and mobile stapes with a stable malleus and tympanic membrane remnants with no mucosal disease. A study by Seife from Egypt, showed extensive incudal losses which was reconstructed with an interposition graft initially showed encouraging results with satisfactory closure (air bone Gap to 10- 20 dB) in 80.4% However, this deteriorated with time. The problem with this technique is that the incus is not securely placed and may abutt against facial canal or promontory. There is also a tendency for the graft to pull away from the incus or to separate it from the stapes. Obstruction to aeration caused by the bulk of the incus may contribute to continued infection. The malleus stapes assembly circumvents the incus interposition problems and gave satisfactory results in 85.7%. The problem with this assembly is that it does not allow for efficient sound transmission as the angle between the malleus and the stapes gets bigger. In such situation the notched incus prosthesis or a PORP yields better results. The malleus footplate assembly a satisfactory result was obtained in 80% of cases with 60% excellent results (< 10 dB AB Gap). Failures are due to inadequate length or to encroachment by the margins of the oval window. Absence of the malleus handle poses a special problem as there is nothing to stabilize the graft tympanic membrane, which tends to pull away from the repositioned ossicle. Staging is desirable in this situation and this author found that the Schuring ossicle cup prosthesis is suitable yet results are not perfect. Total loss of the ossicular chain poses a very difficult problem with reconstruction. Cartilage seems to provide the best results offering the ability to get the desired length, low frequency to extrude or to ankylose to the oval window niche. TORPS initially showed encouraging results of 84.6% satisfactory hearing which deteriorated with time to 51%. HEARING EVALUATION: The danger of too early evaluation of hearing results in terms of air-bone gap closure can not be over emphasized. There is continued hearing loss over time irrespective of the type of reconstruction employed. Most reports on the success or failure of reconstruction of the ossicular chain employ air bone gap closure. This is useful information when comparing the performance of one material to another, but it may be inappropriate from the point of view of the patient. Improvement of the patient's overall auditory performance is the aim of ossiculoplasty and this is what reduces the patients auditory disability not the closure of an air bone gap. In general the degree of disability is determined by the status of the better ear. The ideal of bilateral normal hearing is often unattainable, and so in advising patients regarding surgery for hearing gain it is important not to forget the contribution of the other ear. In most cases the proposed surgery the worst ear is selected, but unless the this can restore symmetrical or nearly symmetrical hearing, or convert the operated ear into the better ear, the patient is unlikely to experience a reduction in disability. The requirements for patient benefits to be achieved the postoperative air conduction average over the speech frequencies (0.5, 1, 2, and 4 KHz) must be <30 dB or the interaural difference reduced to < 15 dB. 15dB corresponds to the cross-attenuation effect of the skull. SURGICAL TECHNIQUE: INCUS REPLACEMENT PROSTHESIS: Incus replacement prosthesis is used in defects in the ossicular chain due to incus pathology. In replacement of the incus the stapes must be prepared. If the lenticular process of the incus is attached it must be removed or left inplace if the stapes is extremely mobile to prevent trauma to the inner ear. It is important to remove all squamous epithelium, scar tissue, and mucous membrane. The distance between the head of the stapes and malleus is evaluated. A single notched incus replacement is used unless the malleus is directly over the stapes or extremely far forward. 80% of the cases the height is 2-3mm. The prosthesis is introduced lying on its side on the promontory with the notch just off the tip of the malleus and the hole in the base near the stapes head. With a right angled pick, the manubrium of the malleus is elevated and the body of the prosthesis is engaged with a gently curved pick the notch is slid up along the undersurface of the malleus. The hole in the prosthesis should then engage the stapedial head. the prosthesis is adjusted until it is vertical to the stapes and appears stable. Is should be slightly loose, if wedged to tightly it will have insufficient movement and not produce good hearing results. INCUS-STAPES PROSTHESIS: Incus-stapes prosthesis is used to reconstruct the ossicles when the stapes superstructure is absent. The stapes footplate should be evaluated to determine mobility and any scar or mucosa should be removed. The height between the malleus and the footplate determines the length of the prosthesis and the distance from the center of the stapes to the malleus determines the position of the notch. 80% of the prosthesis are single notched. The prosthesis is place on the promontory with the shaft on the implant on the stapedial footplate and the notch off the tip of the malleus. With the right angle pick, the manubrium of the malleus is elevated, and a gentle curved pick is placed under the implant. The notch is slid up on the malleus. The surgeon should be extremely careful not to exert undue pressure on the stapedial footplate or wedge the prosthesis tightly in place. Again it should be loose, yet not fall over without support. The long process should be centered on the stapedial footplate by advancing it toward the anterior crus. This maneuver will secure a prosthesis that appears slightly to loose. A prosthesis that is a little too long, tends to tip forward and the long process will be on the posterior part of the footplate. This prosthesis should be removed and no attempt at forcing the prosthesis in place because it will fracture or dislocate the footplate. MALLEAR DEFECTS: The malleus head may be fixed in the epitympanum which will decrease the mobility of the ossicular chain. Management consist of first separating the incudostapedial joint to prevent inner ear injury. Next, the mobility of the stapes is ascertained to be sure it is not fixed. The incudomallear joint is engaged with a right angle pick, and the incus is mobilized and remove. After exposing the head of the malleus its short process is removed with a malleus nipper. The ossicular chain is then rebuilt with the incus replacement prosthesis. Another mallear defect is erosion and shortening of the manubrium of the malleus. Often the incus is normal and mobile. In this situation it is recommended that the incus be removed as well as the head of the malleus and the neck. Reconstruction is carried out with homograft malleus and incus prosthesis. A two stage operation is recommended since the tensor tympani tendon is no longer present to stabilize and the malleus will not be secure. COMBINED DEFECTS OF MALLEUS AND OSSICLES: Erosion of the incus and loss of the stapes superstructure constitute the most common multiple defect of the ossicular chain. This requires the incus-stapes prosthesis. Another is a completely fixed ossicular chain. First the incudostapedial joint must be separated. If the stapes is fixed this requires a stapedotomy. When the stapes is mobile, the incus should be removed and the mobility of the malleus is ascertained. If mobile the incus prosthesis will due it not it must be removed. The most severe is the loss of all ossicles except the footplate which occurs with cholesteatoma. These can be rebuilt with homograft malleus and tympanic membrane and IS prosthesis. PORPS can are frequently used in this situation. COMPLICATION: Intraoperative immediate complication consist of using a prosthesis with too much height or forcing it into place. With the incus prosthesis it could result in fracture of the stapes superstructure, dislocation of the stapes, tear of the annular ligament with a perilymphatic fistula, severe or total SNHL. With the incus-stapes prosthesis complication could consist of stapedial footplate fracture or pushing the footplate into the vestibule. To prevent these complications the prosthesis must be handled gently and sudden undue pressure avoided. If a resulting tear in the annular ligament or crack in the footplate occurs, a tissue seal of fat or fascia should be place as a seal. The ossicular reconstruction must be aborted at that time with a second stage done at later date. Immediate post operative complication might be vertigo which is related to unrecognized oval window trauma. If the reconstruction was difficult, the possibility of perilymph fistula is possible. Exploration may be necessary if conservative therapy fails to resolve symptoms. Potential delayed postoperative complications might be erosion or extrusion of the prosthesis. The cause may be recurrent middle ear cholesteatoma, poor skin or tympanic membrane. If this occurs and the hearing remains good, the surgeon may elevate the tympanomeatal flap and carry the elevation over the prosthesis leaving a perforation that can be fixed by conventional means. If hearing is poor the prosthesis should be removed and replaced. STAPES REPLACEMENT: INTRODUCTION: Otosclerosis is an abnormal resorption and deposition of bone in the labyrinthine capsule and the middle ear. It is noted in 1% of the white population and is primarily transmitted autosomal dominant with incomplete penetrance. Carhart's notch is a 10-30 dB loss in bone conduction at 2000Hz is presumed to be secondary to stapedial fixation. This disease is the most common cause of stapes fixation. HISTORY: Shea in the late 50's replaced the stapes with a polyethylene prosthesis and a vein graft for coverage of the oval window. Schuknecht modified this procedure to combined fat or connective tissue and wire prosthesis. House, in 1962, started using gelatin sponge to rest the wire prosthesis which has not been used due to the increased risk of granuloma formation. Hough, describe the anterior crurotomy technique. SURGICAL TECHNIQUE: A standard tympanomeatal flap is elevated. Usually the scutum area of bone must be removed with a curet to expose the oval window and stapes superstructure. The surgeon assess the mobility of the ossicular chain, and the stapes footplate region is then inspected to confirm footplate fixation from the otosclerotic lesion. Various techniques are preformed to mobilize the stapes. Anterior crurotomy with partial stapedectomy involves the removal of the anterior footplate and the anterior crus. This is good for patients with isolated anterior fixation. The footplate is fractured in the midportion and only the anterior half is removed. A connective tissue graft is then placed over the exposed area. The incudostapedial joint is left intact and stapedial tendon is left undivided. In many patients more extensive disease is present and complete stapedectomy or stapedotomy is needed. Then the stapedial tendon with a sharp instrument is severed and a control hole in the footplate is made prior to separation of the incudostapedial joint. The superstructure of the stapes is fractured and extracted. The entire footplate is then removed in a piece meal fashion using small hooks. The oval window is sealed with a graft and the prosthesis is place. In obliterative otosclerosis removal of the footplate is not feasible due to severe fixation. A fine microstapes drill is used to place a 0.8 to 1 mm opening which allows a prosthesis to be place over a connective tissue graft. Stapedotomy is now used on less severe cases with good surgical results. The surgical technique is to created a fenestra in the midportion of the stapes using a drill, pick or laser. A piston prosthesis is then positioned and connective tissue is placed to prevent fistula. This technique has show less frequency of postoperative cochlear deafness and improved AB gap closure at 2000 Hz. PROSTHESIS: A variety of prosthesis have been developed. Earlier prosthesis with a sharp or beveled end have been found to cause postoperative fistulas and are not used. House gelatin sponge wire prosthesis is not use due to the increased risk for reparative granulomas. The design that has proven itself is the wire prosthesis and connective tissue graft. The prosthesis design includes a wire crimped tightly around the incus, a wire teflon piston, and a Robinson-type bucket handle. POSTOPERATIVE RESULTS: Postoperative hearing result reveal closure of the AB gap to within 10 dB or the preoperative bone conduction level in about 90% of the patients. Ten percent of the patients experience no improvement in hearing and some postoperative cochlear loss (3 percent persistent profound SNHL). Postoperative follow up suggest a progressive high-frequency SNHL in some post stapedectomy patients. It still remains unclear whether this is due to cochlear otosclerosis or long- term postsurgical effect. COMPLICATING FACTORS: Anatomical variations such as aberrant jugular bulb and stapedial artery causing bleeding. Profuse perilymph gusher found in patients with cochlear aqueduct seen with congenital footplate fixation. Fracture of the long process of the incus can occur. A floating footplate which requires a control hole to be placed and the use of a small hook to remove the footplate. If it becomes severely depressed into the vestibule and surgical attempts at removal should be avoided due to the high incidence of cochlear deafness. Revision stapedectomy is needed with prosthesis failure due to displacement or incus tip erosion. Other failures are footplate refixation, perilymph fistula, otosclerotic regrowth, and lateralization of the oval window membrane. This procedure improves the patient in less than 65% of the cases and postoperative cochlear deafness is 7x more prevalent. COMPLICATIONS: The primary risk of stapedectomy is postoperative cochlear deafness (1-3%) Postoperative balance disorders are usually transitory but occasionally can be persistent. Also altered taste, tympanic perforation, facial nerve injury. Tinnitus following stapedectomy is somewhat unpredictable and is not necessarily related to the success of the procedure. CONCLUSION: There are many different prosthesis and techniques to use to reconstruct the middle ear ossicles. It is also changing with the development of new synthetic materials and alterations of old techniques. The ossicular chain reconstruction is a good procedure which is very beneficial to many patients. --------------------------------------------------------------------------- BIBLIOGRAPHY Applebaum, EL. "An Hydroxyapatite Prosthesis for Defects of the Incus Long Process." LARYNGOSCOPE, 103; March 1993: 330-332. Bailey BJ. Head and Neck Surgery - Otolaryngology, Vol II: J.B. Lippincott. 1993: 1667-1675. Black B. "Ossiculoplasty Prognosis: The SPITE Method of Assessment." THE AMERICAN JOUNRNAL OF OTOLOGY, 13(6); November 1992: 544-551. Goldenberg, RA. "Hydroxylapatite Ossicular Replacement Prosthesis: Results in 157 Consecutive Cases." LARNYGOSCOPE, 102; October 1992: 1091- 1096. Goldenberg, RA. "Hydroxylapatite ossicular Replacement Prosthesis: A Four-year Experience." OTOLARYNGOLOGY- HEAD AND NECK SURGERY, 106; March 1992: 261-269. House JW. "Stapedectomy Technique." OTOLARYNGOLOGY CLIN NORTH AMERICA, 26(3); June 1993: 389-93. Lesser TH. "Mechanics and Materials in Middle Ear Reconstuction." CLIN OTOLARYGOL, 16; 1991: 29-32. Nikolaou A. "Ossiculoplasty with the use of autografts and synthetic prosthetic materials: A comparison of results in 165 cases." THE JOURNAL OF LARYNGOLOGY AND OTOLOGY, 22; April 1992: 692- 694. Seifi EL. "Options in Ossiculoplasy." EAR NOSE AND THROAT JOURNAL, 70(11); November 1991: 750-757. Toner JC. "Realities in Ossiculoplasy." JOURNAL OF LARYNGOLOGY AND OTOLOGY, 105(7); July 1991: 529- 533. --------------------------------END---------------------------------------