E. Covelli

G. Magliulo

M. Re.

M.C. Appiani

M.G. Colicchio

M. C. Appiani

M. G. Colicchio

RE, Massimo

IRIS UniversitÃ  Politecnica delle Marche

The LaryngoscopeVC 2012 The American Laryngological,Rhinological and Otological Society, Inc.How I Do ItMalleostapedotomy With a Self-Crimping Superelastic NitinolProsthesisGiuseppe Magliulo, MD; Mario Ciniglio Appiani, MD; Maria Giovanna Colicchio, MD;Edoardo Covelli, MD; Massimo Re, MDKey Words: malleostapedotomy, otosclerosis, revision surgery.Laryngoscope, 123:492–495, 2013INTRODUCTIONOne of the most difficult and time-consuming stepsin malleostapedotomy surgery1,2 is the crimping of theprosthesis onto the malleus handle manually. The adventof the nitinol prosthesis (Gyrus nitinol piston [GNP];Gyrus ENT LLC, Bartlett, TN) significantly reduced thedifficulty of this surgical step, rendering its fixation tothe malleus easy and fast.3–5 However, Kwok et al.6 ana-lyzed the performance of the GNP and observed that thisprosthesis has only three contact points with the malleushandle, with a risk of posterior rotation on the axis of thelonger diameter of the malleus after closure.Recently, a new superelastic nitinol stapes prosthe-sis with a self-recoil property has been introduced forstapes surgery.7,8 This prosthesis consists of a piston inpolytetrafluoroethylene and a self crimping band-shapedloop made of superelastic nitinol (SC-PTFE) (AudioTech-nologies, Gossolengo, Italy). It requires no crimping orthe use of heat or a laser to close the prosthesis.This study presents our experience with a series ofpatients using this prosthesis.MATERIALS AND METHODSBetween 2008 and 2011, 14 patients (six male, eightfemale; mean age, 43.1 years; range, 24–62 years) underwentmalleostapedotomy. Patient data were collected prospectively.The clinical symptoms, otoscopy, and pre- and postoperative au-diometry (250–4,000 Hz) were evaluated in each patient. Thepatients were all informed of the aims of the malleostapedotomyand the possible problems associated with it. The patients werealso given the alternative option of wearing a hearing aid. Onlypatients who agreed to participate in the study were included.As nitinol is composed of nickel, patients with a diagnosedallergy to nickel were excluded.Under local anesthesia, an endaural approach was per-formed using the technique described by Fisch1 and Fischet al.2 After confirming the altered mobility of the incus malleo-lar joint by palpating the malleus handle with a hook, themalleus head and incus were disarticulated and the incus wasremoved. A 0.6 to 0.8-mm diamond burr was used to section themalleus head together with the anterior malleus ligament whenthe mobility of the malleus handle appeared absent or markedlyreduced. This maneuver is essential because the anterior mal-leus ligament is frequently calcified; consequently, it remainswhen the malleus head is sectioned with malleus nippers.9 Thisunavoidably increases the incidence of failure.The chorda tympani was preserved to improve the stabili-zation of the prosthesis. The central portion of the remnants ofthe footplate were perforated using manual perforators. Finally,in all patients, a 0.4-mm SC-PTFE was used (Fig. 1). As Fischet al.2 described, the SC-PTFE connecting piece was bent toadapt the prosthesis to the angle between the malleus handleand footplate and promontory. Then, the modified prosthesis wastrimmed after calculating its length with a measuring rod placedperpendicular to the stapes footplate. Note that 0.5 mm must beadded to consider the protrusion of the piston in the vestibule. Aspecific microforceps was used to insert the prosthesis. The pros-thesis hook opens when it is pressed into the grooves of themicroforceps, and it is easily assembled onto the malleus handleas close as possible to the lateral malleus process and the open-ing of the footplate (Fig. 2). The superelastic properties of thenitinol determined the self-attachment of the prosthesis, whichrequired no further manipulation (Fig. 3). Then, the remainingsteps for a traditional stapedotomy were performed.The patients were given 40 mg of prednisolone, 250 mg ofacyclovir, and 2.2 g of amoxicillin þ clavulanic acid intrave-nously during surgery and then daily for the first 5postoperative days.From the ‘‘Organi di Senso’’ Department (G.M., M.C.A., M.G.C., E.C.),University ‘‘La Sapienza,’’ Rome; and Department of Clinical Sciences(M.R.), Marche Polytechnic University, Ancona, Italy.Editor’s Note: This Manuscript was accepted for publication April2, 2012.The authors have no funding, financial relationships, or conflictsof interest to disclose.Send correspondence to Giuseppe Magliulo, MD, Via Gregorio VIIn. 80, 00165 Rome, Italy. E-mail: giuseppemagliuloorl@yahoo.comDOI: 10.1002/lary.23382Laryngoscope 123: February 2013 Magliulo et al.: Self-Crimping Prosthesis in Malleostapedotomy492All patients were followed (range, 11–34 months; meanduration, 19.3 months) with microscopy of the ear and pure-toneaudiometry (PTA) (frequency range, 250–4000 Hz for the PTAcalculation) 1 and 6 months postoperatively, and then yearly.The significance of the parameters was analyzed statisti-cally using the Bonferroni t test.RESULTSThe ossicular pathologies that can cause preopera-tive hearing loss are listed in Table I. Pathologicalchanges in the incus and malleus were combined withother stapes abnormalities in 78% of patients.The postoperative hearing results are presented inTable II. Based on the American Academy of Otolaryn-gology hearing committee guidelines,10 the postoperativeair-bone gaps at four frequencies (0.5, 1, 2, and 3 kHz )were calculated from the postoperative air conductionPTA minus bone conduction PTA determined at 1 year.The postoperative air-bone gap closure was deemed sat-isfactory (within 20 dB) in 78.6% of cases and within 30dB in 92.9%.Table III presents the influence of malleostapedot-omy on the postoperative bone-conduction threshold.This ratio was calculated from preoperative minusFig. 1. The 0.4-mm polytetrafluoroethylene connecting piece wasbent to adapt the self crimping-polytetrafluoroethylene (SC-PTFE)prosthesis to the angle between the malleus handle and footplateand promontory. Then the modified prosthesis was trimmed toallow the piston to protrude into the vestibule by 0.5 mm andinserted using special microforceps.Fig. 2. The prosthesis hook opens when it is pressed into thegrooves of the microforceps, and it is easily assembled onto themalleus handle as close as possible to the lateral malleolar process.Fig. 3. The self-crimping nature of the SC-PTFE facilitates its de-finitive attachment to the malleus handle.TABLE I.Distribution of the Ossicular Pathologies Causing PreoperativeHearing Loss.Intraoperative Findings No.IncusLong process totally eroded 4Subluxated 2Fixed 4MalleusFixed 1Partial 3Laryngoscope 123: February 2013 Magliulo et al.: Self-Crimping Prosthesis in Malleostapedotomy493postoperative bone-conduction thresholds at 1, 2, and 4kHz measured 6 months after surgery.10 Only onepatient had sensorineural hearing loss >10 dB. No caseof dead ear or persistent vertigo was observed in oursample.The mean operating time was 52.8 6 11.2 minutes.During follow-up, no toxic or allergic reaction was observed.DISCUSSIONFisch et al.2 popularized malleostapedotomy in re-vised otosclerosis surgery and tympanosclerosis. Forsuccessful results, several critical points in the surgicaltechnique must be considered. The first fundamentalsurgical step is the removal of the anterior tympanomal-leolar process and ligament. Because these anatomicalstructures may be calcified, as Fisch et al.2 noted, thiscondition is frequently misdiagnosed due to the subjec-tive evaluation of malleus fixation by direct palpationand to the limited use of laser-Doppler vibrometry,which would overcome this diagnostic dilemma. Thesestructures must be removed to free the malleus handle,otherwise head removal may be insufficient to ensureadequate movement. Another essential procedure is topreserve the integrity of the tendon of the malleus mus-cle and the chorda tympani. This improves the stabilityof the prosthesis during closure of the loop.The choice of prosthesis also influences the finalhearing results. Kwok et al.6 examined the performanceof three well-known prostheses: the GNP, the Storztitanium stapes piston (STSP), and Kurz malleovestibu-lopexy piston (MVP). They evaluated the quality of theattachment at the malleus handle, the position of thepiston with respect to the footplate, and its depth of pen-etration into the vestibule. The loop of the prosthesisand the modality of crimping influenced the ease andquality of prosthesis attachment. Specifically, the GNPwas the easiest to close at the malleus handle because itis self-crimping on using bipolar cautery forceps. How-ever, it formed only three contact points with themalleus handle. The STSP required more time to insertthan the GNP because the loop must be crimped withlarge, smooth, straight alligator forceps. It had circum-ferential contact, resulting in a more stable position onthe lateral malleolar process. Finally, the placement ofthe MVP was more difficult technically, resulting indistortion of the angle when the malleus handle wasparticularly large. Moreover, it tended to be displaced to-ward the umbo. Overall, the STSP made the bestconnection with the malleus handle. Finally, Kwoket al.6 stated that the ideal prosthesis must possess thecapacity of molding itself to the oval surface of the mal-leus handle. Note that the angle the malleus handlemade with the center of the footplate varied by 12 to15. Without adjustment, this variation may result indisplacement of the prosthesis anteriorly or posteriorlyand unpredictable protrusion into the vestibule. In termsof the position of the piston and penetration depth intothe vestibule, Kwok et al.6 found that the STSP wasbest, with highly reproducible vestibular depth and anoptimal position perpendicular to the center of the foot-plate. This was obtained through manual adjustment ofthe prosthesis. The other two prostheses protruded intothe vestibule in a more variable way. They tended torotate anteriorly or posteriorly, losing the correct perpen-dicular orientation with the center of footplate.Our preliminary hearing results with the SC-PTFEwere similar to those reported in the literature. In ourseries, only one patient had sensorineural deteriorationexceeding 20 dB. It should be emphasized that the SC-PTFE is simple to implant, and its self-crimping propertyreduces the operating time. However, Reineke et al.7 andHornung et al.8 reported that a thicker long process of theincus prevented implantation of the SC-PTFE in four sta-pedotomy patients because the loop diameter wasinsufficient, and its superelasticity prevented it from adapt-ing to these anatomic conditions as with other prostheses(STSP or manually crimping (MC)-PTFE). Implantationwas performed in all of our patients. Obviously, this doesnot exclude the possibility that some malleus handles withparticularly large circumferences preclude the ability toperform a malleostapedotomy with the superelastic nitinolprosthesis. Hornung et al.8 observed that the future devel-opment of this prosthesis should include the provision of afull range of diameters to cope with the long process of theincus and the malleus handle.CONCLUSIONThe SC-PTFE self-crimping nature facilitatesattachment to the malleus handle and reduces operatingtime. The SC-PTFE was biocompatible, with no observedTABLE II.Postoperative Hearing Results.Air-Bone Gap, dBPostoperative Air PTA MinusPostoperative Bone PTA at 0.5,1, 2, and 3 kHzNo. %10 5 35.711–20 6 42.921–30 2 14.3>31 1 7.1PTA ¼ pure-tone audiometry.TABLE III.Influence of Malleostapedotomy on the PostoperativeBone-Conduction Threshold.Preoperative Bone MinusPostoperative Bone at 1, 2,and 4 kHzNo. %Overclosure 1 7.1No change 12 85.8Sensorineuralhearing loss1 7.1Dead ear — —Laryngoscope 123: February 2013 Magliulo et al.: Self-Crimping Prosthesis in Malleostapedotomy494allergic or toxic reaction during follow-up. The SC-PTFEled to the recovery of conductive hearing loss in 78.6% ofpatients at high surgical risk.BIBLIOGRAPHY1. Fisch U. Tympanoplasty, Mastoidectomy and Stapes Surgery. Stuttgart,Germany: Georg Thieme Verlag; 1994:212–271.2. Fisch U, Acar GO, Huber AM. Malleostapedotomy in revision surgery forotosclerosis. Otol Neurotol 2001;22:776–785.3. Rajan GP, Atlas MD, Subramaniam K, Eikelboom RH. Eliminating thelimitations of manual crimping in stapes surgery? A preliminary trialwith the shape memory Nitinol stapes piston. Laryngoscope 2005;115:366–369.4. Roosli C, Schmid P, Huber AM. Biocompatibility of Nitinol stapes prosthe-sis. Otol Neurotol 2011;32:265–270.5. Van Rompaey V, Claes G, Potvin J, Wouters K, Van de Heyning P. System-atic review of the literature on nitinol prosthesis in surgery for otoscle-rosis: assessment of the adequacy of statistical power. Otol Neurotol2011;32:357–366.6. Kwok P, Fisch U, Nussbaumer M, Herkenhoff S, Strutz J. Morphology ofthe malleus handle and the comparison of different prostheses for mal-leostapedotomy. Otol Neurotol 2009;30:1175–1185.7. Reineke U, Ebmeyer J, Plett D, et al. Superelastic nitinol stapes prosthe-ses [in German]. Laryngorhinootologie 2010;89:271–275.8. Hornung JA, Brase C, Zenk J, Iro H. Results obtained with a new supere-lastic nitinol stapes prosthesis in stapes surgery. Otol Neurotol 2011;32:1415–1421.9. Huber AM, Koike T, Wada H, Nandapalan V, Fisch U. Fixation of the an-terior mallear ligament: diagnosis and consequences for hearing resultsin stapes surgery. Ann Otol Rhinol Laryngol 2003;112:348–355.10. Committee on Hearing and Equilibrium. Committee on Hearing and Equi-librium guidelines for the evaluation of results of treatment of conduc-tive hearing loss. Otolaryngol Head Neck Surg 1995;113:186–187.Laryngoscope 123: February 2013 Magliulo et al.: Self-Crimping Prosthesis in Malleostapedotomy495

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Malleostapedotomy with a self-crimping superelastic nitinol prosthesis.

Malleostapedotomy with a self-crimping superelastic nitinol prosthesis.

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