Myringoplasty in Simple Chronic Otitis Media: Critical Analysis of Long-Term Results in a 1,000-Adult Patient Series

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1 Otology & Neurotology 33:48Y53 Ó 2011, Otology & Neurotology, Inc. Myringoplasty in Simple Chronic Otitis Media: Critical Analysis of Long-Term Results in a 1,000-Adult Patient Series *Massimiliano Nardone, Ryan Sommerville, James Bowman, and *Giovanni Danesi *ENT Department and Microsurgery of the Skull Base, Ospedali Riuniti, Bergamo, Italy; and ÞDepartment of ENT, Head and Neck Surgery, Logan Hospital, Brisbane, Australia Objectives: Investigate the recurrence of chronic otitis media after primary and revision myringoplasty, compare long-term anatomic and audiologic results of underlay and overlay myringoplasty, and examine the prognostic factors. Study Design: Retrospective study. Patients: Approximately 1,040 adult patients with chronic simple otitis media undergoing a myringoplasty (overlay and underlay) by different surgeons at a single institution (ENT Department of Bergamo Ospedali Riuniti) between May 1999 and March Methods: The cumulative recurrence rate of chronic otitis media during 10-year follow-up period was calculated using a Kaplan-Meier survival analysis. A multivariate analysis was used to evaluate different prognostic factors based on long-term outcome in myringoplasty. Results: The overall 10-year graft success rate was 78% in 1,040 patients. The 10-year recurrence rate of chronic otitis media was 15% in overlay myringoplasty and 26% using the underlay technique ( p G 0.05). In revision myringoplasty, the overlay technique showed a better success rate than underlay ( p G 0.05). Significant recovery was observed in the air conduction thresholds and air-bone gaps in both groups with no statistical difference between techniques ( p = 0.1). Multivariate analysis demonstrated that the underlay myringoplasty technique, a pathologic contralateral ear and an anterior or subtotal perforation, using a perichondrial graft or age of surgery younger than 40 years were statistically significant ( p G 0.01) factors that negatively influenced the myringoplasty outcomes. Conclusion: More successful outcomes in primary and revision surgery for chronic otitis media occurred using overlay myringoplasty, although there were more minor postoperative complications. Both clinical and technical variables affected the success rate of myringoplasty. Key Words: Chronic otitis mediav MyringoplastyVPrognostic factorsvsurvival analysis. Otol Neurotol 33:48Y53, The goals of a successful myringoplasty are to eradicate the existing pathology, to create a sound-conducting mechanism in a well-aerated middle ear cleft, and to maintain these achievements over time (1). The surgical procedure is performed for the restoration of the tympanic membrane either in uncomplicated chronic otitis media (COM) or in some cases of adhesive otitis media with a retraction pocket (2). Several different techniques have been developed for myringoplasty, but the 2 principal methods currently utilized are the overlay and the underlay, in which the graft is placed over and under the tympanic remnants respectively (3). Despite the presence of many papers on myringoplasty, there are few studies Address correspondence and reprint requests to Massimiliano Nardone, M.D., ENT Department and Microsurgery of the Skull, Base, Ospedali Riuniti, Bergamo Largo Barozzi 1, 24100, Bergamo, Italy; mnardone@ospedaliriuniti.bergamo.it The authors disclose no conflicts of interest. in the literature that have made a comparative analysis of these 2 techniques in a large series of patients (4). Furthermore, multiple prognostic factors have been identified as influential in myringoplasty success such as patient age, the perforation size, the contralateral Eustachian tube function, and the surgical approach (5Y12). Therefore, the aims of this study were to evaluate the outcomes of myringoplasty in simple COM, comparing the overlay versus underlay technique in anatomic and functional outcomes, respectively. Additionally, identifiable clinical and technical prognostic factors were examined using multivariate analysis. MATERIALS AND METHODS Patients Approximately 1,102 adult patients (ages ranged from 19 to 87 yr) underwent myringoplasty performed by different 48

2 MYRINGOPLASTY: A 1,000-PATIENT SERIES 49 TABLE 1. General group characteristics Underlay MPL Overlay MPL No. of patients No. of patients lost at follow-up Average age 41.6 yr 42.5 yr Anesthetic (%) General Local General Local Cause of perforation (%) Infection Trauma Unknown Infection Trauma Unknown Sex (%) Male Female Male Female MPL indicates myringoplasty. surgeons (4 senior and 3 junior) from May 1999 to March 2009 at the same institution. Senior surgeons performed 72% of the overlay and 68% of the underlay myringoplasties. The design of the study was retrospective, with a complete review possible in 94.4% (1,040 patients) of the overall sample because of 62 patients being lost to follow-up. These patients came from other institutions for revision surgery, with most being managed with overlay myringoplasty. They were subsequently followed up by the original hospitals and were not included as successful cases (Table 1). Myringoplasty was performed on 922 patients as primary cases, and 85 patients as revision surgery. There were an additional 33 patients with a previous tympanoplasty for cholesteatoma. There were 787 (75.7%) operations performed as an underlay myringoplasty and 253 (24.3%) procedures using the overlay technique. The preoperative site of perforation and the ossicular chain status are shown in Table 2. All patients underwent a clinical otologic examination and a pure tone audiogram from 250 Hz to 8 khz in the preoperative and postoperative period. The hearing outcomes were evaluated using the criteria stated by the Committee on Hearing and Equilibrium Guidelines (13), and the air-bone gap was considered closed when it was within 10 db. No preoperative computed tomographic imaging was requested. The average clinical follow-up was 48 months, with a range of 12 to 130 months. The subsequent clinical progress was recorded onto a database with a successful myringoplasty defined as full take of the graft with closure of the perforation and a minimum follow-up of 3 months after the operation. The first postoperative otomicroscopy was performed at 1 month, and the hearing outcome assessed 2 months later. The presence of perforation or atelectasis was defined as a surgical failure. Surgical Technique Most operations were performed under local anesthesia. The retroauricular approach was used in 86.3%, reserving the Shambaugh endaural (13.5%) or transmeatal (1.2%) approach for inferior or posterior perforations not larger than 2 or 3 mm. The graft consisted of autologous temporalis fascia in most operations as shown in Figure 1. The fat plug from auricular lobe was only used for very small perforations (1Y2 mm).cartilage was harvested from the concha or tragus in some cases of subtotal or total perforations or revision surgery, whereas perichondrium was harvested from the tragus in patients with small and inferoposterior perforations approached by endaural or transmeatal means. The location of the preoperative perforation is demonstrated in Figure 2. The overlay myringoplasty was utilized essentially in subtotal and anterior perforations (Table 2) mainly by senior surgeons. We performed both myringoplasty and ossiculoplasty in a few cases with hearing results that were less comparable because of low case numbers. Furthermore, we preferred to perform ossiculoplasty as secondstage surgery because a successful ossiculoplasty requires an intact eardrum with a well-aerated middle ear cleft. In the underlay technique, the margins of the perforation were freshened, and the mucosal surface made raw for about 2 mm circumferentially. At the 6 o clock and 12 o clock positions, a curvilinear incision was made over the posterior canal to elevate a tympanomeatal flap in a standard fashion. The condition of the middle ear ossicles and labyrinthine windows was checked, TABLE 2. Perforation site preoperatively Ossicular chain status Anatomic condition of the middle ear Underlay MPL (%) Overlay MPL (%) Anterior 31.3 Anterior 10.6 Subtotal 10.8 Subtotal 84.8 Total 0 Total 3.6 Posterior 26.8 Posterior 0 Inferior 26.1 Inferior 1 Central 5 Central 0 M-I erosion 0.4 M-I erosion 0.4 I-S erosion 0.4 I-S erosion 0.6 I-S absent 0.4 I-S absent 0.2 M erosion 3 M erosion 2 I erosion 7.4 I erosion 9.2 M-I absent 0 M-I absent 2 I absent 2 I absent 2.8 C intact + fixed 4.2 C intact + fixed 3 C intact + mobile 84.2 C intact + mobile 77.8 C absent 0 C absent 2 C indicates ossicular chain; I, incus; M, malleus; S, stapes. FIG. 1. Material used for the graft.

3 50 M. NARDONE ET AL. FIG. 2. Perforation site preoperatively. and the chorda tympani nerve was spared. The graft was placed under the malleus and tympanic membrane remnants and supported by Gelfoam in the middle ear space. In the overlay technique, care was taken to separate the squamous epithelium from the annulus, malleus, and tympanic remnants and to elevate a meatal skin flap from the anterior annulus in a bucket-handle fashion. Occasionally, an anterior canalplasty was performed to check the anterior tympanomeatal angle. The graft was placed between the fibrous layer and the elevated squamous epithelium with the anterior edge of the graft not beyond the anterior annulus to avoid blunting. A small hole in the superior portion of the graft was made to slip the malleus through this hole and allow the graft to be supported by the malleus and prevent lateralization. The elevated meatal skin flap and squamous epithelium were then repositioned. FIG. 4. Cumulative proportion of adult patients with an intact drum at 120 months after surgery, overlay versus underlay technique. Analysis The cumulative recurrence rate of COM was calculated using a Kaplan-Meier survival analysis with an average follow-up of 48 months. This analysis allowed examination of the distribution times between surgery and recurrence of any perforation, estimating the successful rate of myringoplasty at each point in time. It was applied to all cases and compared between the surgical techniques in the first operation and revision surgery. A p value less than 0.05 was regarded as significant. Yates correction was considered for the comparison of samples with a large difference in case numbers. Hearing outcome was evaluated by the application of a T-test. Various prognostic factors were considered, that is, age in the 2 groups according to the median values shown in Table 1 (18Y40 yr old, over 40 yr old), sex, preoperative anatomic condition, surgical technique and approach, the status of the ossicular chain, the location and size of the perforation, preoperative otorrhea, status of the opposite ear, experience of the surgeon, previous and related surgery, and the different grafts used. We determined the risk of recurrent COM by using the application of forward stepwise multivariate analysis, with the p value set to The statistical analysis was carried out by means of the SPSS statistical package (version 11.0; SPSS, Chicago, IL, USA). RESULTS Complete healing of the tympanic perforation was obtained in 852 cases (82.1%), whereas 149 subjects (14.3%) presented with reperforation. In the remaining cases, we observed 1 iatrogenic cholesteatoma (0.1%), 1 graft lateralization (0.1%), 8 episodes of blunting (0.8%), FIG. 3. Cumulative proportion of adult patients with an intact drum at 120 months after surgery (Kaplan-Meier test). FIG. 5. Cumulative proportion of adult patients with an intact drum after revision surgery, overlay versus underlay technique.

4 MYRINGOPLASTY: A 1,000-PATIENT SERIES 51 TABLE 3. Hearing results MPL technique PTA threshold (db) p Preoperative result Air-bone gap Underlay 25.4 T Overlay 28.5 T 12.5 High-tone bone Underlay 17.4 T Conduction level Overlay 18.3 T 6.6 Postoperative result Air-bone gap Underlay 10.4 T Overlay 14.2 T 11.5 High-tone bone Underlay 17.9 T Conduction level Overlay 18.7 T 6.3 PTA indicates pure tone average. 17 cases of atelectasis (1.6%), 6 retraction pockets (0.6%), and 4 cases of tympanic sclerosis (0.4%). In the underlay myringoplasty, the graft take-up rate was 77.3%, whereas in the overlay technique, it was 86.9%. The overall recurrence rate (Kaplan-Meier survival analysis) in a 10-year follow-up showed the graft uptake to be 85% 1 year after the operation, 81% after 2 years, 80% after 4 years, and 78% after 10 years (Fig. 3). In the comparison of the 2 surgical techniques, the overlay myringoplasty showed a better graft rate (Log rank test with Yates correction; p G 0.05) than underlay myringoplasty both in the short term (92% versus 82% in the first year) and the long term (85% versus 74% after 10 yr) (Fig. 4). Sixty underlay and 35 overlay procedures were performed in revision surgery with a shorter follow-up (24 mo). The recurrence rate in the overlay technique was significantly less (Log rank test with Yates correction; p G 0.05) than with the underlay (Fig. 5). The air-bone gap was closed in 559 patients (68.5%) in the first postoperative year, 435 cases in the underlay group (55.3%), and 124 in the overlay group (49.0%). The postoperative hearing outcome between the 2 techniques did not show a significant difference (Table 3). The hearing gain was significant in both groups from the preoperative to the postoperative status, p = 0.04 in overlay and p = 0.02 in underlay. We did not observe any overclosure or significant operative damage of high-frequency bone conduction (Table 3). In the 224 cases with a fixed or interrupted ossicular chain, ossiculoplasty during myringoplasty was performed only in 16 cases (7%) with a good hearing gain in 4 patients. The final cumulative R was 0.74 in the multivariate analysis and accounted for an acceptable variance that did not reduce considerably the predictive power of the variables entered. The factors that seemed to influence a less successful outcome using the multivariate analysis were as follows: the underlay technique, the status of the opposite ear, an anterior or subtotal perforation, the use of perichondrium, and age younger than 40 years. Preoperative otorrhea was a borderline factor in the outcome of myringoplasty as well as surgeon experience. The use of a cartilage graft and the overlay technique seemed to be a positive factor for a successful myringoplasty. The surgical approach and the remaining factors did not influence the outcome (Table 4). DISCUSSION Our finding that the overlay technique showed a significantly higher success rate than the underlay method in both primary and revision surgery is interesting. Although the overlay technique was performed in fewer cases, it showed better success in both the early postoperative period (92% versus 82% in the first year) and the long term (85% versus 74% after 10 yr). Perhaps this can be explained by better exposure of the anterior sulcus (via an anterior canalplasty), the preservation of the fibrous annulus, and a 2-fold vascularization. In the underlay technique, the visualization of the anterior sulcus can be more difficult, with resultant graft failure because of misplacement and the decreased vascularization of the anterior sulcus. A reduction of the middle air space also may increase risk of adhesions (14,15). When we examined other published data comparing the 2 myringoplasty techniques, 3 studies found no significant difference between the techniques with a success rate of about 90% (16Y18). In the prospective study of Singh et al. (17), the author suggested that the underlay technique was better than the overlay because of its technical ease, shorter postoperative healing time, and fewer complications (6.6% versus 33%, respectively). However, Albera et al. (12) observed a significant difference between the 2 techniques with a 93% success rate in overlay myringoplasty ( annular wedge technique ) and 76% in the underlay arm, with the technique chosen depending on the size and site of perforation. In the literature, some authors (6,19) stated that the experience of the surgeon was a significant factor influencing the surgical success rate. In our large series, this factor impacted on the myringoplasty outcome positively but did not reach a statistically significant result as predictor of successful myringoplasty. Senior surgeons performed the TABLE 4. Multivariate analysis of prognostic factors R + Impact on MPL outcome p Underlay MPL 0.78 N a Quadrant of perforation 0.76 P a (I-Po-C) Contralateral ear pathology 0.74 N a Quadrant of perforation 0.72 N a (subtotal) Cartilage 0.69 P a Quadrant of perforation 0.69 N a (anterior) Perichondrium graft 0.68 N a Age (G40 yr) 0.66 N a Preoperative otorrhea 0.65 NS 0.01 Surgeon experience 0.64 NS 0.05 Overlay MPL 0.64 NS 0.06 Age (940 yr) 0.60 NS 0.1 Temporal fascia 0.51 NS 0.3 Ossicular chain integrity 0.44 NS 0.6 Retroauricular approach 0.44 NS 0.6 C indicates central; N, negative; NS, not significant; p, p value; P, positive; Po, posterior; R +, cumulative determining coefficient (R). a Significant (p G 0.01).

5 52 M. NARDONE ET AL. majority of all myringoplasties and achieved a considerable success rate by the overlay myringoplasty. However, we would recognize that this technique does require greater surgical skill, is usually a longer procedure time, and potentially causes more complications such as anterior blunting or lateralization (18,20). We observed different degrees of success with the utilization of either cartilage or perichondrium as a graft. Cartilage was consistently reliable especially in subtotal perforations or revision surgery, although it was used only in a few cases. It contributes minimally to an inflammatory tissue reaction, provides firm support to retraction preventing adhesions to promontory and resistance to infection during the healing period (21). Interestingly, perichondrium did not show the same benefit. It was used only in few cases with small and inferoposterior perforations via endaural or transmeatal approach. It is difficult to interpret this result as the case selection was different. Perhaps this finding is due to the positioning and case selection rather than to its physical characteristics. We agree with Albera et al. (12) that the exposure of the surgical field is important in the success of myringoplasty. As shown in the Kaplan-Meier graphs (Figs. 3 and 4), most of the unsuccessful cases were observed in the early post operative period. The short term post operative failures resulting in reperforation were most often due to infection with graft necrosis or failure of the anterior adaptation of the graft. Long-term causes included atrophy or subsequent episodes of acute otitis media with perforation (7). We found that the presence of preoperative otorrhea was not a restrictive factor in performing myringoplasty, and perhaps as suggested in the literature, it is the closure of the middle ear cavity that favors middle ear normalization (22Y24). However, other authors have demonstrated otorrhea to be a significant factor in graft healing (6,19,25,26). The success of the graft uptake was poorer in patients whose opposite ears were atelectatic or perforated with secretive effusion. Many authors viewed the status of the contralateral ear as an important measure of Eustachian-tube function. Merenda et al. (27) suggested that disease of the contralateral ear seemed to be a negative prognostic indicator and should be considered when planning myringoplasty. Mastoidectomy was not necessary for successful repair of tympanic perforations, although it impacted the clinical course by reducing future procedures and disease progression as shown in the study by McGrew and Jackson (28): an aerated mastoid cavity acts as a buffering system to reduce the impact of pressure changes experienced by the middle ear and generated by periods of poor Eustachiantube function. In the present study of adult myringoplasty, we found the age younger than 40 years as a prognostic indicator in myringoplasty failure. Poor Eustachian-tube function has been offered as an explanation by some authors as to why younger age may be correlated with lower tympanoplasty success rates (19,25,27). The cumulative R of 0.74 validated acceptably the prediction power of the variables entered, but further studies need to investigate other factors that enhance this prediction. In our series, the air-bone gap was closed in 68.5% of cases with ossicular chain integrity (816 patients), with no hearing gain difference between the 2 techniques. Singh et al. (17) observed differently that 92.8% of patients undergoing underlay myringoplasty had a gain in hearing after surgery as compared with 57.1% receiving the overlay technique. Packer et al. (16) also had better functional results in the underlay technique than overlay (54% versus 36%). However, good hearing outcomes were obtained using the overlay technique in the series of Sheehey and Anderson (80%) (18) and Seifi (84.6%) (20). It is difficult to ascribe a specific cause for the residual conductive hearing loss after a successful graft without any ossicular chain discontinuity. One of the reasons could be that the neotympanic membrane is not as mobile as the original one, thereby increasing the impedance of the middle ear. CONCLUSION We believe that the results of our study show that the overlay myringoplasty offers the best results in regard to short- and long-term follow-up and also in both the primary operation as well as revision surgery. However, the overlay myringoplasty requires a higher level of surgical skill, as evidenced by mostly senior surgeons in our department performing this technique. It often is associated with a longer operative time and can have a greater number of postoperative problems. Clinical factors related to the patient affected the myringoplasty outcome either in the short or in the long postoperative period. Acknowledgments: No financial or other support was received for this work. REFERENCES 1. Albu S, Babighian G, Trabalzini F. Prognostic factors in tympanoplasty. Am J Otol 1998;19:136Y Babighian G. Il trattamento delle tasche di retrazione. In: il colesteatoma: attuali orientamenti diagnostici e terapeutici. Atti del XXIV Convegno AOOI; Ziino Ed Glasscock ME III. Tympanic membrane grafting with fascia: overlay vs undersurface technique. Laryngoscope 1973;83:754Y Mangal S, Ashutosh R, Sarmishtha B. Comparative study of the underlay and overlay techniques of myringoplasty in large and subtotal perforations of the tympanic membrane. J Laryngol Otol 2003; 117:444Y8. 5. Bhat NA. Retrospective analysis of surgical outcome, symptom changes and hearing improvement following myringoplasty. J Otolaryngol 2000;29:229Y Vartiainen E, Nuutinen J. 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