- Email: [email protected]
Optimizing effectiveness of laser tympanic membrane fenestration in chronic otitis media with effusion
International Journal of Pediatric Otorhinolaryngology 58 (2001) 59 – 64 www.elsevier.com/locate/ijporl
Optimizing effectiveness of laser tympanic membrane fenestration in chronic otitis media with effusion Clinical and technical considerations Linda Brodsky a,b,*, Steve Cook c, Ellen Deutsch c, Patrick Brookhouser e, Charles Bower d, Milton Waner d, James Reilly c, David Chait e, Christopher Poje a,b, Steve Shaha f a
Departments of Otolaryngology, State Uni6ersity of New York at Buffalo, School of Medicine and Biomedical Sciences, and The Children’s Hospital of Buffalo/Kaleida Health, 219 Bryant Street, Buffalo, NY 14222, USA b Department of Pediatrics, State Uni6ersity of New York at Buffalo, School of Medicine and Biomedical Sciences, and The Children’s Hospital of Buffalo/Kaleida Health, Buffalo, NY, USA c The Department of Surgery, Di6ision of Otolaryngology, Alfred I. DuPont Hospital for Children, Wilmington, DE, USA d The Department of Otolaryngology, Arkansas Children’s Hospital, Little Rock, AR, USA e The Department of Otolaryngology, Boystown National Research Hospital, Omaha, NE, USA f The Gartner Group, Boston, MA, USA Received 7 June 2000; received in revised form 14 November 2000; accepted 18 November 2000
Abstract Objecti6e: To describe the patient, disease and clinical characteristics that optimize the effectiveness of laser tympanic membrane fenestration (LTMF) to treat chronic otitis media with effusion (OME). Setting: Four pediatric otolaryngology tertiary referral centers. IRB approved; participation by informed consent. Methods: An observational clinical effectiveness trial was conducted in 164 ears (94 children), who had chronic OME. All patients were candidates for insertion of pressure equalization tubes (PETs) but agreed to undergo LTMF instead. Clinical and audiologic follow-up are reported at 90 days after LTMF. Outcome Measures: Clinical effectiveness was defined as an effusion free middle ear at otoscopy with A or C1 tympanogram and normal hearing. Results: At 90 days, 66% of the 95 evaluable ears were effusion free, all with normal hearing. Children younger than 4 years (PB 0.04), who had shorter durations of effusion (PB 0.009), and who experienced longer duration of fenestration patency (FP) (P B 0.009) correlated to improved outcomes. Conclusions: The use of LTMF to create 2 – 3 weeks of middle ear ventilation in patients with chronic OME (middle ear effusion (MEE) for 3 months or greater) is effective in 66% of 95 (58%) of ears evaluable at 90 days follow-up. This study provides basic information needed to optimize the use of LTMF today and enhance research efforts in the future. © 2001 Elsevier Science Ireland Ltd. All rights reserved. Presented at the Research Forum — American Academy of Otolaryngology/Head and Neck Surgery, New Orleans, Louisiana, September, 1999. * Corresponding author. Tel.: + 1-716-8787852; fax: + 1-716-8787585. E-mail address: [email protected] (L. Brodsky).
0165-5876/01/$ - see front matter © 2001 Elsevier Science Ireland Ltd. All rights reserved. PII: S 0 1 6 5 - 5 8 7 6 ( 0 0 ) 0 0 4 6 7 - 5
60
L. Brodsky et al. / Int. J. Pediatr. Otorhinolaryngol. 58 (2001) 59–64
1. Introduction Chronic otitis media with effusion (OME) is defined as the presence of fluid in the middle ear space for 3 months [1]. Symptoms of acute inflammation, such as otalgia and fever, are usually absent, but middle ear effusion (MEE) alone can cause discomfort, ear fullness and hearing loss. The negative impacts of chronic MEE are well known and include; fluctuating conductive hearing loss leading to speech, language, cognitive and behavioral problems [2–5], recurrent acute otitis media [6] and the potential development of chronic otitis media with its sequellae of atelectasis, perforation, cholesteatoma and otomastoiditis [2,7]. Studies of the natural history of chronic OME reveal that even when treated with watchful waiting [6,8,9], additional antibiotics [8,10 – 12] and systemic or intranasal steroids [13], many patients do not resolve after 3 months and eventually require middle ear ventilation to resolve. Middle ear ventilation is most commonly achieved by the use of pressure equalization tube (PET) insertion [14 – 16]. Recently, reports of the use of a less invasive form of middle ear ventilation, laser tympanic membrane fenestration (LTMF), have increased the interest in ventilation as a primary treatment modality for chronic OME. LTMF was first described in human and experimental animals by Goode in 1982 [17]. Further work in animals [18 – 20] and more recently in adults [21,22] and children [23 – 26] has established a promising role for this treatment modality. The purpose of this study is to describe both the patient and disease characteristics and the technical parameters used in creating the laser fenestration that optimize the effectiveness of resolving a single episode of chronic OME.
col driven study that was approved by each site’s institutional review board. Participation was by informed consent. All 94 patients were referred to the investigators for the treatment of chronic OME for at least 3 months despite medical therapy. All were candidates for, and would have been offered, PET insertion but instead were offered office-based LTMF according to the procedure described below. The presence of MEE for greater than 3 months was established by pediatrician records with the use of prior audiograms and tympanograms, and in some cases, by direct observation by the investigator. Exclusion criteria included; cleft palate9 cleft lip, craniofacial anomalies, mental retardation, cerebral palsy, chronic nasal obstruction (from rhinosinusitis/allergic rhinitis or obstructive adenoid hyperplasia), external auditory canal stenosis and chronic disease i.e. diabetes, renal failure, etc. Patient, disease and technical laser characteristics studied are listed in Table 1.
2.2. Study protocol At initial evaluation the ears were evaluated by a pediatric otolaryngologist using pneumatic otoscopy, often with a microscope. Presence of MEE was further established by tympanometry. LTMF was performed as described in Section 2.4. Table 1 Patient, disease and technical factors studied Patient factors Age Gender Environmental factors Smoke Daycare Bottle use Pacifier Disease factors
2. Methods
Duration of effusion Type of effusion Earlier pet insertion
2.1. Patients Technical factors
A multisite, prospective, observational clinical cohort effectiveness trial was conducted in 94 patients (164 ears). Four sites and eleven pediatric otolaryngologists enrolled patients for this proto-
Fenestration size Wattage Quadrant Number of pulses used
L. Brodsky et al. / Int. J. Pediatr. Otorhinolaryngol. 58 (2001) 59–64
Subsequent to LTMF, the ears were re-evaluated by trained otoscopists (a pediatric otolaryngologist or pediatric otolaryngology nurse practitioner) at days 7, 14, 21, 30, 60, and 90. Home visits occurred on days 7 and 21 using a portable pneumatic otoscope and a portable tympanometer. All other ear evaluations were done by the physician at an office visit.
2.3. Outcome measures Resolution of MEE was defined as absence of fluid from the middle ear space as diagnosed on pneumatic otoscopy and tympanomettry (types A and C1) at 90 days follow-up. Hearing must also have returned to normal. Complications and other untoward effects are also described.
2.4. Laser tympanic membrane fenestration This procedure has been described in detail in the earlier work [24 – 26]. Briefly, the external auditory canal is anesthetized with topical 32% pontacaine [27]. The laser (OtoLAM™, ESC Medical, Yokneam, Israel) is set at a fenestration size (FS) (range of choices 0.2 – 3.0 mm) and wattage (0 – 40 watts) chosen by the surgeon; increased wattage was, in general, used for thicker appearing tympanic membranes. The fluid type was recorded. The fluid was not aspirated from the middle ear cleft [28]. Eardrops were placed in the ear at the time of LTMF and for 3 days afterwards, three times daily.
2.5. Statistical analysis Data were entered into an Excel spreadsheet. SPSS statistical package was used for data analysis. Student’s t-test, 2 analysis and correlation coefficients were used as appropriate. Significance level was reported at P B0.05.
3. Results
3.1. Patient factors All patients allowed completion of the LTMF.
61
Table 2 Middle ear status after laser tympanic membrane fenestration at 30, 60 and 90 days Days
Normal Recurred Open fenestration Total
30 n (%)
60 n (%)
90 n (%)
58 48 17 123
68 40 4 112
63 29 3 95
(47) (39) (14) (100)
(61) (36) (4) (100)
(66) (31) (3) (100)
Of the 95 (58%) evaluable ears at 90 days, 63 (66%) tympanic membranes were closed and effusion free at 90 days. Outcomes at 30, 60 and 90 days are listed in Table 2. Although only 47% of ears were resolved at 30 days, many ears were still fenestrated and a fair number of ears in which the effusion recurred at 30 days resolved over the next 2 months without further treatment. Ten ears underwent a second laser fenestration at day 60, 5 (50%) were normal 90 days after the second LTMF and are not included in the 90-day results. In addition, the three persistent perforations closed by 6 months post-LTMF. Transient physician fear was noted in some children, no other complications were recorded.
3.2. Demographics Mean age was 53.5 months (S.D.= 45.0; median= 36.0; range 5–235). Children less than 4 years of age more often resolved their effusion at 90 days (PB 0.04). Male:female ratio was 2:1. Among them 95% were Caucasian, 5% were black. Equal numbers of right and left ears underwent LTMF with no significant outcome difference between ears. Neither gender nor race correlated to outcomes. Insurance coverage was categorized as managed care (i.e. referral necessary) and ‘self’ referred. Both categories contained both government and private sector supported patients. The duration of effusion was significantly greater at presentation in children who were in managed care and required a referral to seek a specialist’s care (P5 0.03).
62
L. Brodsky et al. / Int. J. Pediatr. Otorhinolaryngol. 58 (2001) 59–64
3.3. En6ironmental factors Smoke exposure was found in the home in 19% of families and out of the home in another 21% of families. For children under 4 years of age, 38% had used pacifiers beyond the first 6 months of life, 23% had taken a bottle in the supine position in the last 6 months before LTMF. Breast-feeding was practiced in 70, 40% had breast-fed for greater than 3 months. Also 57% of children were in day care for greater than 20 h per week, almost all of them in a large (\6 children) day care setting. No one environmental factor impacted outcome at 90 days. In order to assess the effect of a combination of environmental factors, each factor was assigned one point in order to create an environmental adversity index (mean= 1.46, S.D. =10.6, median=1.0, range 0 – 4). The environmental adversity index did not correlate to resolution of effusion at 90 days. Season (at LTMF or at 90-day follow-up) did not correlate to outcome.
Earlier tubes had been inserted in 23 children (25%). Their resolution rates did not differ from the group as a whole. However, the eight children who had more than one set of PETs had lower rates of resolution than those who had one or none earlier, PB0.05. Hearing before and 90 days after LTMF are shown in Table 3. Normal or near normal hearing at presentation was correlated to resolution at 90 days (P B 0.01).
3.5. Technical factors The mean FS was 2.5 mm (S.D. = 0.18, median= 2.6, range 2.0 –2.8). Increased FS showed a strong trend to longer duration of fenestration patency (FP) (mean= 2.7 weeks, S.D.= 1.7, median=2.0, range 1–12 weeks) (PB 0.06). Duration of fenestration was correlated positively to outcome at 90 days (PB 0.001). The number of pulses, watts or quadrant of the TM did not correlate to clinical outcome.
3.4. Disease factors Recurrent episodes of acute otitis media (defined by otalgia, fever, irritability and treatment with antibiotics) during the 6 months prior to study enrollment were reported in 82% of children, mean= 2.6 (S.D. = 2.1, median= 2.0, range= 0–10). Earlier history of recurrent acute otitis media did not correlate to outcome. The duration of MEE averaged 5.7 months (S.D.= 4.0, median= 4.0, range= 3 – 24). The duration of effusion was inversely correlated to outcome, PB 0.009. A shorter duration of effusion was more common in children less than 4 years of age, PB 0.002. No fluid was seen in the middle ear in 11%, serous in 42%, mucoid in 39% and mixed in 8%. Fluid consistency did not correlate to outcome. Approximately 30% of ears had a transient recurrence of MEE, usually associated with an upper respiratory tract infection, which was cleared by 90 days. Children with ‘dry’ ear taps (11%) had recurrence of MEE at the same rate the cohort as a whole indicating that fluid may have been present but not visualized at LTMF.
4. Discussion The 2–3 weeks of ventilation provided by LTMF in this study resulted in 64% of ears returning to normal at 90 days. This finding is consistent with the earlier reported clearance fate between 50 and 87% in both adults and children [22 –25]. The effect is at least twice as good as other interventions described except for PET inTable 3 Hearing results at 0 and 90 daysa Pre-LTMF
Normal Mild loss Moderate loss Severe loss a
90 days post-LTMF
n
%
n
44 42 49 1
32 31 36 1
42 12 9 0
% 67 19 14 0
Using pure tone averages of the worse hearing ear or sound field frequency specific responses, normal was defined as 515 dB; mild 20–40 dB; moderate 45–60 dB.
L. Brodsky et al. / Int. J. Pediatr. Otorhinolaryngol. 58 (2001) 59–64
sertion. The lack of need for general anesthesia and the need for long term PET care adds to the usefulness of this procedure. It is apparent from this study that optimizing results requires careful attention to both patient selection and to laser settings. LTMF in younger children, who have a shorter duration of effusion are more likely to result in a favorable outcome. It is possible that these two factors potentiate each other, that is children older than 4 years may have more recalcitrant disease, and therefore, are likely to need prolonged middle ear ventilation. Similarly the correlation of outcome to hearing at onset is another indicator that LTMF works best in less severely affected ears. It is not surprising that the average duration of effusion was 5.7 months with a median of 4 months. Otolaryngologists are frequently confronted with patients who have received multiple, often ineffective courses of antibiotics and anti-inflammatories. The reluctance of parents and pediatricians to submit to PET insertion is likely the underlying reason for delay in referral. Availability of LTMF provides reasonable firstline alternative and might result in earlier referral and possibly increased effectiveness of treatment of chronic OME. The technical factor of increased FS resulted in a longer duration of FP is particularly important in planning further clinical trials. For chronic OME, it is suggested that spot sizes of 2.4 – 2.6 mm should be used to affect cure. The optimal wattage setting to achieve a complete fenestration with one firing is still difficult to assess from clinical examination, however, increased experience will likely resolve this challenge. The 34 ears treated with FS sizes of 2.0 – 2.3 mm may have been cured when a larger spot size was used. One of the limitations of the study design is lack of a control group. However, there is a rich literature on this subject for both LTMF and other treatment modalities for this group of children, who have 3 months of unresolved MEE. Normally they would be treated with PET insertion. Approximately, two of every three ears treated with LTMF did not need to undergo
63
general anesthesia and PET insertion. The effectiveness of LTMF has been addressed in earlier publications [17,22 –25]. Another concern is the lack of follow-up in 42% of ears. Although somewhat detracting, the percentage of resolved ears were consistent through all 3 months and were favorable demonstrating resolution at twice the rate of recurrences. In addition, the stated purposes of this study were to identify those patient, disease and technical factors that enhance the effectiveness of LTMF, not solely the effectiveness. In conclusion, the use of LTMF to create 2–3 weeks of middle ear ventilation in patients with MEE for 3 months or greater is reasonably effective in 66% of ears in this series. Younger children with shorter duration of effusion and mild to no hearing loss are patient and disease characteristics that are associated with better outcomes. FSs of 2.4 –2.6 mm are also important in optimizing outcomes. The need for future study is evident, however, the present study provides a very useful platform of information to optimize clinical care today and enhance research design in the future.
Acknowledgements Funding for this study was provided in part by ESC Medical Systems (Yokneam, Israel). The study design, reporting of results and conclusions are solely those of the authors. The authors acknowledge the donation of Floxin Otic eardrops, which were used by some patients in this study (Bayer Corporation, Pharmaceutical Division, West Haven, Connecticut). Completion of this study was greatly enabled by Lucille Kingston, PNP, Debbie Jacobi, PNP, Laurie Giza, Marilyn Smistek and Joanne Matteliano.
References [1] C.D. Bluestone, Definitions, terminology, and classification, in: R.M. Rosenfeld, C.D. Bluestone (Eds.), Evidence-Based Otitis Media, B.C. Decker, Hamilton, 1999, pp. 85 – 104.
64
L. Brodsky et al. / Int. J. Pediatr. Otorhinolaryngol. 58 (2001) 59–64
[2] L. Dusdieker, G. Smith, B. Booth, J. Woodhead, G. Milavetz, The Long-term outcome of nonsuppurative otitis media with effusion, Clin. Pediatr. 24 (1985) 181–186. [3] M.P. Haggard, S.C. Smith, Impact of otitis media on child quality of life, in: R.M. Rosenfeld, C.D. Bluestone (Eds.), Evidence-Based Otitis Media, B.C. Decker, Hamilton, 1999, pp. 375– 398. [4] J. Madell, Impact of otitis media on auditory function, in: R.M. Rosenfeld, C.D. Bluestone (Eds.), Evidence-Based Otitis Media, B.C. Decker, Hamilton, 1999, pp. 337–352. [5] L. Vernon-Feagans, Impact of otitis media on speech, language, cognition, and behavior, in: R.M. Rosenfeld, C.D. Bluestone (Eds.), Evidence-Based Otitis Media, B.C. Decker, Hamilton, 1999, pp. 353–374. [6] R.M. Rosenfeld, Natural history of untreated otitis media, in: R.M. Rosenfeld, C.D. Bluestone (Eds.), EvidenceBased Otitis Media, B.C. Decker, Hamilton, 1999, pp. 179– 206. [7] W. Doyle, C. Alper, C. Bluestone, et al., Middle ear physiology and pathophysiology, Ann. Otol. Rhinol. Laryngol. 107 (1998) 14–20. [8] R.M. Rosenfeld, Amusing parents while nature cures otitis media with effusion, Int. J. Pediatr. Otorhinolaryngol. 43 (1998) 189– 192. [9] G. Zielhuis, H. Straatman, G. Racht, P. Van Den Broek, Analysis and presentation of data on the natural course of otitis media with effusion in children, Int. J. Epidemiol. 19 (1990) 1037– 1044. [10] R. Rosenfeld, C. Post, Meta-analysis of antibiotics for the treatment of otitis media with effusion, Otolaryngol. Head Neck Surg. 106 (40) (1992) 378–386. [11] R. Rosenfeld, What to expect from medical treatment of otitis media?, Pediatr. Infect. Dis. J. 14 (1995) 731–737. [12] R.I. Williams, T. Chalmers, K.C. Stange, F.T. Chalmers, S.J. Bowlin, Use of antibiotics in preventing recurrent acute otitis media and in treating otitis media with effusion: a meta-analytic attempt to resolve the brouhaha, J. Am. Med. Assoc. 270 (1983) 1344–1351. [13] R. Rosenfeld, E. Mandel, C. Bluestone, Systemic steroids for otitis media with effusion in children, Arch. Otolaryngol. Head Neck Surg. 117 (1991) 984–989. [14] B.W. Armstrong, R.B. Armstrong, Tympanostomy tubes their use, abuse, and cost-benefit ratio, Laryngoscope 89 (1979) 443– 449 Abstract. [15] C.D. Bluestone, D.L. Lee, What to expect from surgical therapy?, in: R.M. Rosenfeld, C.D. Bluestone (Eds.),
[16]
[17] [18]
[19]
[20]
[21]
[22]
[23]
[24] [25]
[26]
[27]
[28]
.
Evidence-Based Otitis Media, B.C. Decker, Hamilton, 1999, pp. 207– 222. C. Le, D. Freeman, B. Fireman, Evaluation of ventilating tubes and myringotomy in the treatment of recurrent or persistent otitis media, Pediatr. Infect. Dis. J. 10 (1991) 2 – 11. R. Goode, CO2 laser myringotomy, Laryngoscope 92 (1982) 420– 423. G.D. Lyons, D. Webster, D.F. Mouney, R. Lousteau, Anatomical consequences of CO2 laser surgery of the guinea pig ear, Laryngoscope, (1978) 1749– 1754. O. Soderberg, S. Hellstrom, L. Stenfors, Myringotomy made by CO2 laser-an alternative to the ventilation tube?, Acta Otolaryngol. (Stockh.) 97 (1984) 335– 341. H. Valtonen, D. Poe, D.F. Perrault, I. Lombardo, M. Pankratov, S. Shapshay, Experimental CO2 laser myringotomy: a preliminary animal study, SPIE 2395 (1998) 277– 284. H. Silverstein, S. Rosenberg, Diagnosis and treatment of perilymph fistula, in: R. Bussy, S. Hunsberger (Eds.), Surgical Techniques of the Temporal Bone and Skull Base, Lea & Febiger, London, 1992, pp. 49 – 53. H. Silverstein, J. Kuhn, D. Choo, Y. Krespi, S. Rosenberg, P. Rowan, Laser-assisted tympanostomy, Laryngoscope 106 (1995) 1067– 1074. D. Cohen, G. Siegel, J. Krespi, Y. Schechter, M. Slatkine, Middle ear laser office ventilation (LOV) with a CO2 laser flashscanner, J. Clin. Laser Med. Surg. 16 (1998) 107– 109. G. Siegel, Description of an office technique for laser ventilation of the ears, ENT J. 79 (3) (2000) 176– 177. G. Siegel, L. Brodsky, M. Waner, S. Shaha, Office based laser assisted tympanic membrane fenestration in adults and children — pilot data to support an alternative to traditional approaches to otitis media, Int. J. Pediatr. Otolaryngol. 53 (2000) 111– 120. L. Brodsky, P. Brookhouser, D. Chait, et al., Office-based insertion of pressure equalization tubes: the role of laserassisted tympanic membrane fenestration, Laryngoscope 109 (1999) 2009– 2014. H. Silverstein, D. Call, Tetracaine base: an effective surface anesthetic for the T tympanic membrane, Arch. Otolaryngol. 90 (1969) 150– 151. E. Egger, Is aspiration necessary before tympanostomy tube insertion?, Laryngoscope 108 (1998) 443– 444.
Optimizing effectiveness of laser tympanic membrane fenestration in chronic otitis media with effusion Clinical and technical considerations Linda Brodsky a,b,*, Steve Cook c, Ellen Deutsch c, Patrick Brookhouser e, Charles Bower d, Milton Waner d, James Reilly c, David Chait e, Christopher Poje a,b, Steve Shaha f a
Departments of Otolaryngology, State Uni6ersity of New York at Buffalo, School of Medicine and Biomedical Sciences, and The Children’s Hospital of Buffalo/Kaleida Health, 219 Bryant Street, Buffalo, NY 14222, USA b Department of Pediatrics, State Uni6ersity of New York at Buffalo, School of Medicine and Biomedical Sciences, and The Children’s Hospital of Buffalo/Kaleida Health, Buffalo, NY, USA c The Department of Surgery, Di6ision of Otolaryngology, Alfred I. DuPont Hospital for Children, Wilmington, DE, USA d The Department of Otolaryngology, Arkansas Children’s Hospital, Little Rock, AR, USA e The Department of Otolaryngology, Boystown National Research Hospital, Omaha, NE, USA f The Gartner Group, Boston, MA, USA Received 7 June 2000; received in revised form 14 November 2000; accepted 18 November 2000
Abstract Objecti6e: To describe the patient, disease and clinical characteristics that optimize the effectiveness of laser tympanic membrane fenestration (LTMF) to treat chronic otitis media with effusion (OME). Setting: Four pediatric otolaryngology tertiary referral centers. IRB approved; participation by informed consent. Methods: An observational clinical effectiveness trial was conducted in 164 ears (94 children), who had chronic OME. All patients were candidates for insertion of pressure equalization tubes (PETs) but agreed to undergo LTMF instead. Clinical and audiologic follow-up are reported at 90 days after LTMF. Outcome Measures: Clinical effectiveness was defined as an effusion free middle ear at otoscopy with A or C1 tympanogram and normal hearing. Results: At 90 days, 66% of the 95 evaluable ears were effusion free, all with normal hearing. Children younger than 4 years (PB 0.04), who had shorter durations of effusion (PB 0.009), and who experienced longer duration of fenestration patency (FP) (P B 0.009) correlated to improved outcomes. Conclusions: The use of LTMF to create 2 – 3 weeks of middle ear ventilation in patients with chronic OME (middle ear effusion (MEE) for 3 months or greater) is effective in 66% of 95 (58%) of ears evaluable at 90 days follow-up. This study provides basic information needed to optimize the use of LTMF today and enhance research efforts in the future. © 2001 Elsevier Science Ireland Ltd. All rights reserved. Presented at the Research Forum — American Academy of Otolaryngology/Head and Neck Surgery, New Orleans, Louisiana, September, 1999. * Corresponding author. Tel.: + 1-716-8787852; fax: + 1-716-8787585. E-mail address: [email protected] (L. Brodsky).
0165-5876/01/$ - see front matter © 2001 Elsevier Science Ireland Ltd. All rights reserved. PII: S 0 1 6 5 - 5 8 7 6 ( 0 0 ) 0 0 4 6 7 - 5
60
L. Brodsky et al. / Int. J. Pediatr. Otorhinolaryngol. 58 (2001) 59–64
1. Introduction Chronic otitis media with effusion (OME) is defined as the presence of fluid in the middle ear space for 3 months [1]. Symptoms of acute inflammation, such as otalgia and fever, are usually absent, but middle ear effusion (MEE) alone can cause discomfort, ear fullness and hearing loss. The negative impacts of chronic MEE are well known and include; fluctuating conductive hearing loss leading to speech, language, cognitive and behavioral problems [2–5], recurrent acute otitis media [6] and the potential development of chronic otitis media with its sequellae of atelectasis, perforation, cholesteatoma and otomastoiditis [2,7]. Studies of the natural history of chronic OME reveal that even when treated with watchful waiting [6,8,9], additional antibiotics [8,10 – 12] and systemic or intranasal steroids [13], many patients do not resolve after 3 months and eventually require middle ear ventilation to resolve. Middle ear ventilation is most commonly achieved by the use of pressure equalization tube (PET) insertion [14 – 16]. Recently, reports of the use of a less invasive form of middle ear ventilation, laser tympanic membrane fenestration (LTMF), have increased the interest in ventilation as a primary treatment modality for chronic OME. LTMF was first described in human and experimental animals by Goode in 1982 [17]. Further work in animals [18 – 20] and more recently in adults [21,22] and children [23 – 26] has established a promising role for this treatment modality. The purpose of this study is to describe both the patient and disease characteristics and the technical parameters used in creating the laser fenestration that optimize the effectiveness of resolving a single episode of chronic OME.
col driven study that was approved by each site’s institutional review board. Participation was by informed consent. All 94 patients were referred to the investigators for the treatment of chronic OME for at least 3 months despite medical therapy. All were candidates for, and would have been offered, PET insertion but instead were offered office-based LTMF according to the procedure described below. The presence of MEE for greater than 3 months was established by pediatrician records with the use of prior audiograms and tympanograms, and in some cases, by direct observation by the investigator. Exclusion criteria included; cleft palate9 cleft lip, craniofacial anomalies, mental retardation, cerebral palsy, chronic nasal obstruction (from rhinosinusitis/allergic rhinitis or obstructive adenoid hyperplasia), external auditory canal stenosis and chronic disease i.e. diabetes, renal failure, etc. Patient, disease and technical laser characteristics studied are listed in Table 1.
2.2. Study protocol At initial evaluation the ears were evaluated by a pediatric otolaryngologist using pneumatic otoscopy, often with a microscope. Presence of MEE was further established by tympanometry. LTMF was performed as described in Section 2.4. Table 1 Patient, disease and technical factors studied Patient factors Age Gender Environmental factors Smoke Daycare Bottle use Pacifier Disease factors
2. Methods
Duration of effusion Type of effusion Earlier pet insertion
2.1. Patients Technical factors
A multisite, prospective, observational clinical cohort effectiveness trial was conducted in 94 patients (164 ears). Four sites and eleven pediatric otolaryngologists enrolled patients for this proto-
Fenestration size Wattage Quadrant Number of pulses used
L. Brodsky et al. / Int. J. Pediatr. Otorhinolaryngol. 58 (2001) 59–64
Subsequent to LTMF, the ears were re-evaluated by trained otoscopists (a pediatric otolaryngologist or pediatric otolaryngology nurse practitioner) at days 7, 14, 21, 30, 60, and 90. Home visits occurred on days 7 and 21 using a portable pneumatic otoscope and a portable tympanometer. All other ear evaluations were done by the physician at an office visit.
2.3. Outcome measures Resolution of MEE was defined as absence of fluid from the middle ear space as diagnosed on pneumatic otoscopy and tympanomettry (types A and C1) at 90 days follow-up. Hearing must also have returned to normal. Complications and other untoward effects are also described.
2.4. Laser tympanic membrane fenestration This procedure has been described in detail in the earlier work [24 – 26]. Briefly, the external auditory canal is anesthetized with topical 32% pontacaine [27]. The laser (OtoLAM™, ESC Medical, Yokneam, Israel) is set at a fenestration size (FS) (range of choices 0.2 – 3.0 mm) and wattage (0 – 40 watts) chosen by the surgeon; increased wattage was, in general, used for thicker appearing tympanic membranes. The fluid type was recorded. The fluid was not aspirated from the middle ear cleft [28]. Eardrops were placed in the ear at the time of LTMF and for 3 days afterwards, three times daily.
2.5. Statistical analysis Data were entered into an Excel spreadsheet. SPSS statistical package was used for data analysis. Student’s t-test, 2 analysis and correlation coefficients were used as appropriate. Significance level was reported at P B0.05.
3. Results
3.1. Patient factors All patients allowed completion of the LTMF.
61
Table 2 Middle ear status after laser tympanic membrane fenestration at 30, 60 and 90 days Days
Normal Recurred Open fenestration Total
30 n (%)
60 n (%)
90 n (%)
58 48 17 123
68 40 4 112
63 29 3 95
(47) (39) (14) (100)
(61) (36) (4) (100)
(66) (31) (3) (100)
Of the 95 (58%) evaluable ears at 90 days, 63 (66%) tympanic membranes were closed and effusion free at 90 days. Outcomes at 30, 60 and 90 days are listed in Table 2. Although only 47% of ears were resolved at 30 days, many ears were still fenestrated and a fair number of ears in which the effusion recurred at 30 days resolved over the next 2 months without further treatment. Ten ears underwent a second laser fenestration at day 60, 5 (50%) were normal 90 days after the second LTMF and are not included in the 90-day results. In addition, the three persistent perforations closed by 6 months post-LTMF. Transient physician fear was noted in some children, no other complications were recorded.
3.2. Demographics Mean age was 53.5 months (S.D.= 45.0; median= 36.0; range 5–235). Children less than 4 years of age more often resolved their effusion at 90 days (PB 0.04). Male:female ratio was 2:1. Among them 95% were Caucasian, 5% were black. Equal numbers of right and left ears underwent LTMF with no significant outcome difference between ears. Neither gender nor race correlated to outcomes. Insurance coverage was categorized as managed care (i.e. referral necessary) and ‘self’ referred. Both categories contained both government and private sector supported patients. The duration of effusion was significantly greater at presentation in children who were in managed care and required a referral to seek a specialist’s care (P5 0.03).
62
L. Brodsky et al. / Int. J. Pediatr. Otorhinolaryngol. 58 (2001) 59–64
3.3. En6ironmental factors Smoke exposure was found in the home in 19% of families and out of the home in another 21% of families. For children under 4 years of age, 38% had used pacifiers beyond the first 6 months of life, 23% had taken a bottle in the supine position in the last 6 months before LTMF. Breast-feeding was practiced in 70, 40% had breast-fed for greater than 3 months. Also 57% of children were in day care for greater than 20 h per week, almost all of them in a large (\6 children) day care setting. No one environmental factor impacted outcome at 90 days. In order to assess the effect of a combination of environmental factors, each factor was assigned one point in order to create an environmental adversity index (mean= 1.46, S.D. =10.6, median=1.0, range 0 – 4). The environmental adversity index did not correlate to resolution of effusion at 90 days. Season (at LTMF or at 90-day follow-up) did not correlate to outcome.
Earlier tubes had been inserted in 23 children (25%). Their resolution rates did not differ from the group as a whole. However, the eight children who had more than one set of PETs had lower rates of resolution than those who had one or none earlier, PB0.05. Hearing before and 90 days after LTMF are shown in Table 3. Normal or near normal hearing at presentation was correlated to resolution at 90 days (P B 0.01).
3.5. Technical factors The mean FS was 2.5 mm (S.D. = 0.18, median= 2.6, range 2.0 –2.8). Increased FS showed a strong trend to longer duration of fenestration patency (FP) (mean= 2.7 weeks, S.D.= 1.7, median=2.0, range 1–12 weeks) (PB 0.06). Duration of fenestration was correlated positively to outcome at 90 days (PB 0.001). The number of pulses, watts or quadrant of the TM did not correlate to clinical outcome.
3.4. Disease factors Recurrent episodes of acute otitis media (defined by otalgia, fever, irritability and treatment with antibiotics) during the 6 months prior to study enrollment were reported in 82% of children, mean= 2.6 (S.D. = 2.1, median= 2.0, range= 0–10). Earlier history of recurrent acute otitis media did not correlate to outcome. The duration of MEE averaged 5.7 months (S.D.= 4.0, median= 4.0, range= 3 – 24). The duration of effusion was inversely correlated to outcome, PB 0.009. A shorter duration of effusion was more common in children less than 4 years of age, PB 0.002. No fluid was seen in the middle ear in 11%, serous in 42%, mucoid in 39% and mixed in 8%. Fluid consistency did not correlate to outcome. Approximately 30% of ears had a transient recurrence of MEE, usually associated with an upper respiratory tract infection, which was cleared by 90 days. Children with ‘dry’ ear taps (11%) had recurrence of MEE at the same rate the cohort as a whole indicating that fluid may have been present but not visualized at LTMF.
4. Discussion The 2–3 weeks of ventilation provided by LTMF in this study resulted in 64% of ears returning to normal at 90 days. This finding is consistent with the earlier reported clearance fate between 50 and 87% in both adults and children [22 –25]. The effect is at least twice as good as other interventions described except for PET inTable 3 Hearing results at 0 and 90 daysa Pre-LTMF
Normal Mild loss Moderate loss Severe loss a
90 days post-LTMF
n
%
n
44 42 49 1
32 31 36 1
42 12 9 0
% 67 19 14 0
Using pure tone averages of the worse hearing ear or sound field frequency specific responses, normal was defined as 515 dB; mild 20–40 dB; moderate 45–60 dB.
L. Brodsky et al. / Int. J. Pediatr. Otorhinolaryngol. 58 (2001) 59–64
sertion. The lack of need for general anesthesia and the need for long term PET care adds to the usefulness of this procedure. It is apparent from this study that optimizing results requires careful attention to both patient selection and to laser settings. LTMF in younger children, who have a shorter duration of effusion are more likely to result in a favorable outcome. It is possible that these two factors potentiate each other, that is children older than 4 years may have more recalcitrant disease, and therefore, are likely to need prolonged middle ear ventilation. Similarly the correlation of outcome to hearing at onset is another indicator that LTMF works best in less severely affected ears. It is not surprising that the average duration of effusion was 5.7 months with a median of 4 months. Otolaryngologists are frequently confronted with patients who have received multiple, often ineffective courses of antibiotics and anti-inflammatories. The reluctance of parents and pediatricians to submit to PET insertion is likely the underlying reason for delay in referral. Availability of LTMF provides reasonable firstline alternative and might result in earlier referral and possibly increased effectiveness of treatment of chronic OME. The technical factor of increased FS resulted in a longer duration of FP is particularly important in planning further clinical trials. For chronic OME, it is suggested that spot sizes of 2.4 – 2.6 mm should be used to affect cure. The optimal wattage setting to achieve a complete fenestration with one firing is still difficult to assess from clinical examination, however, increased experience will likely resolve this challenge. The 34 ears treated with FS sizes of 2.0 – 2.3 mm may have been cured when a larger spot size was used. One of the limitations of the study design is lack of a control group. However, there is a rich literature on this subject for both LTMF and other treatment modalities for this group of children, who have 3 months of unresolved MEE. Normally they would be treated with PET insertion. Approximately, two of every three ears treated with LTMF did not need to undergo
63
general anesthesia and PET insertion. The effectiveness of LTMF has been addressed in earlier publications [17,22 –25]. Another concern is the lack of follow-up in 42% of ears. Although somewhat detracting, the percentage of resolved ears were consistent through all 3 months and were favorable demonstrating resolution at twice the rate of recurrences. In addition, the stated purposes of this study were to identify those patient, disease and technical factors that enhance the effectiveness of LTMF, not solely the effectiveness. In conclusion, the use of LTMF to create 2–3 weeks of middle ear ventilation in patients with MEE for 3 months or greater is reasonably effective in 66% of ears in this series. Younger children with shorter duration of effusion and mild to no hearing loss are patient and disease characteristics that are associated with better outcomes. FSs of 2.4 –2.6 mm are also important in optimizing outcomes. The need for future study is evident, however, the present study provides a very useful platform of information to optimize clinical care today and enhance research design in the future.
Acknowledgements Funding for this study was provided in part by ESC Medical Systems (Yokneam, Israel). The study design, reporting of results and conclusions are solely those of the authors. The authors acknowledge the donation of Floxin Otic eardrops, which were used by some patients in this study (Bayer Corporation, Pharmaceutical Division, West Haven, Connecticut). Completion of this study was greatly enabled by Lucille Kingston, PNP, Debbie Jacobi, PNP, Laurie Giza, Marilyn Smistek and Joanne Matteliano.
References [1] C.D. Bluestone, Definitions, terminology, and classification, in: R.M. Rosenfeld, C.D. Bluestone (Eds.), Evidence-Based Otitis Media, B.C. Decker, Hamilton, 1999, pp. 85 – 104.
64
L. Brodsky et al. / Int. J. Pediatr. Otorhinolaryngol. 58 (2001) 59–64
[2] L. Dusdieker, G. Smith, B. Booth, J. Woodhead, G. Milavetz, The Long-term outcome of nonsuppurative otitis media with effusion, Clin. Pediatr. 24 (1985) 181–186. [3] M.P. Haggard, S.C. Smith, Impact of otitis media on child quality of life, in: R.M. Rosenfeld, C.D. Bluestone (Eds.), Evidence-Based Otitis Media, B.C. Decker, Hamilton, 1999, pp. 375– 398. [4] J. Madell, Impact of otitis media on auditory function, in: R.M. Rosenfeld, C.D. Bluestone (Eds.), Evidence-Based Otitis Media, B.C. Decker, Hamilton, 1999, pp. 337–352. [5] L. Vernon-Feagans, Impact of otitis media on speech, language, cognition, and behavior, in: R.M. Rosenfeld, C.D. Bluestone (Eds.), Evidence-Based Otitis Media, B.C. Decker, Hamilton, 1999, pp. 353–374. [6] R.M. Rosenfeld, Natural history of untreated otitis media, in: R.M. Rosenfeld, C.D. Bluestone (Eds.), EvidenceBased Otitis Media, B.C. Decker, Hamilton, 1999, pp. 179– 206. [7] W. Doyle, C. Alper, C. Bluestone, et al., Middle ear physiology and pathophysiology, Ann. Otol. Rhinol. Laryngol. 107 (1998) 14–20. [8] R.M. Rosenfeld, Amusing parents while nature cures otitis media with effusion, Int. J. Pediatr. Otorhinolaryngol. 43 (1998) 189– 192. [9] G. Zielhuis, H. Straatman, G. Racht, P. Van Den Broek, Analysis and presentation of data on the natural course of otitis media with effusion in children, Int. J. Epidemiol. 19 (1990) 1037– 1044. [10] R. Rosenfeld, C. Post, Meta-analysis of antibiotics for the treatment of otitis media with effusion, Otolaryngol. Head Neck Surg. 106 (40) (1992) 378–386. [11] R. Rosenfeld, What to expect from medical treatment of otitis media?, Pediatr. Infect. Dis. J. 14 (1995) 731–737. [12] R.I. Williams, T. Chalmers, K.C. Stange, F.T. Chalmers, S.J. Bowlin, Use of antibiotics in preventing recurrent acute otitis media and in treating otitis media with effusion: a meta-analytic attempt to resolve the brouhaha, J. Am. Med. Assoc. 270 (1983) 1344–1351. [13] R. Rosenfeld, E. Mandel, C. Bluestone, Systemic steroids for otitis media with effusion in children, Arch. Otolaryngol. Head Neck Surg. 117 (1991) 984–989. [14] B.W. Armstrong, R.B. Armstrong, Tympanostomy tubes their use, abuse, and cost-benefit ratio, Laryngoscope 89 (1979) 443– 449 Abstract. [15] C.D. Bluestone, D.L. Lee, What to expect from surgical therapy?, in: R.M. Rosenfeld, C.D. Bluestone (Eds.),
[16]
[17] [18]
[19]
[20]
[21]
[22]
[23]
[24] [25]
[26]
[27]
[28]
.
Evidence-Based Otitis Media, B.C. Decker, Hamilton, 1999, pp. 207– 222. C. Le, D. Freeman, B. Fireman, Evaluation of ventilating tubes and myringotomy in the treatment of recurrent or persistent otitis media, Pediatr. Infect. Dis. J. 10 (1991) 2 – 11. R. Goode, CO2 laser myringotomy, Laryngoscope 92 (1982) 420– 423. G.D. Lyons, D. Webster, D.F. Mouney, R. Lousteau, Anatomical consequences of CO2 laser surgery of the guinea pig ear, Laryngoscope, (1978) 1749– 1754. O. Soderberg, S. Hellstrom, L. Stenfors, Myringotomy made by CO2 laser-an alternative to the ventilation tube?, Acta Otolaryngol. (Stockh.) 97 (1984) 335– 341. H. Valtonen, D. Poe, D.F. Perrault, I. Lombardo, M. Pankratov, S. Shapshay, Experimental CO2 laser myringotomy: a preliminary animal study, SPIE 2395 (1998) 277– 284. H. Silverstein, S. Rosenberg, Diagnosis and treatment of perilymph fistula, in: R. Bussy, S. Hunsberger (Eds.), Surgical Techniques of the Temporal Bone and Skull Base, Lea & Febiger, London, 1992, pp. 49 – 53. H. Silverstein, J. Kuhn, D. Choo, Y. Krespi, S. Rosenberg, P. Rowan, Laser-assisted tympanostomy, Laryngoscope 106 (1995) 1067– 1074. D. Cohen, G. Siegel, J. Krespi, Y. Schechter, M. Slatkine, Middle ear laser office ventilation (LOV) with a CO2 laser flashscanner, J. Clin. Laser Med. Surg. 16 (1998) 107– 109. G. Siegel, Description of an office technique for laser ventilation of the ears, ENT J. 79 (3) (2000) 176– 177. G. Siegel, L. Brodsky, M. Waner, S. Shaha, Office based laser assisted tympanic membrane fenestration in adults and children — pilot data to support an alternative to traditional approaches to otitis media, Int. J. Pediatr. Otolaryngol. 53 (2000) 111– 120. L. Brodsky, P. Brookhouser, D. Chait, et al., Office-based insertion of pressure equalization tubes: the role of laserassisted tympanic membrane fenestration, Laryngoscope 109 (1999) 2009– 2014. H. Silverstein, D. Call, Tetracaine base: an effective surface anesthetic for the T tympanic membrane, Arch. Otolaryngol. 90 (1969) 150– 151. E. Egger, Is aspiration necessary before tympanostomy tube insertion?, Laryngoscope 108 (1998) 443– 444.