- Email: [email protected]
Effect of the combination of balloon Eustachian tuboplasty and tympanic paracentesis on intractable chronic otitis media with effusion
Effect of the Combination of Balloon Eustachian Tuboplasty and Tympanic Paracentesis on Intractable Chronic Otitis Media with Effusion Maojin Liang MD, Hao Xiong PhD, Yuexin Cai, Yuebo Chen MD, Zhigang Zhang MD, Suijun Chen MD, Yaodong Xu MD, Yongkang Ou MD, Haidi Yang PhD, Yiqing Zheng MD PII: DOI: Reference:
S0196-0709(16)30001-1 doi: 10.1016/j.amjoto.2016.03.006 YAJOT 1704
To appear in:
American Journal of Otolaryngology–Head and Neck Medicine and Surgery
Received date:
24 January 2016
Please cite this article as: Liang Maojin, Xiong Hao, Cai Yuexin, Chen Yuebo, Zhang Zhigang, Chen Suijun, Xu Yaodong, Ou Yongkang, Yang Haidi, Zheng Yiqing, Effect of the Combination of Balloon Eustachian Tuboplasty and Tympanic Paracentesis on Intractable Chronic Otitis Media with Effusion, American Journal of Otolaryngology–Head and Neck Medicine and Surgery (2016), doi: 10.1016/j.amjoto.2016.03.006
This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
ACCEPTED MANUSCRIPT Effect of the Combination of Balloon Eustachian Tuboplasty and Tympanic
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Paracentesis on Intractable Chronic Otitis Media with Effusion
Maojin Lianga,b,c, MD, Hao Xionga,b,c, PhD, Yuexin Caia,b,c, Yuebo Chena,b,c, MD,
SC
Zhigang Zhanga,b,c, MD, Suijun Chena,b,c, MD, Yaodong Xua,b,c, MD, Yongkang Oua,b,c, MD, Haidi Yanga,b,c, PhD, Yiqing Zhenga,b,c*, MD
Department of Otolaryngology, Sun Yat-sen Memorial Hospital, Sun Yat-sen
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a
University, China
Institute of Hearing and Speech-Language Science, Sun Yat-sen University, China
c
Department of Hearing and Speech-Language Science, Xinhua College, Sun Yat-sen
ED
b
Address
PT
University, China
for Yiqing Zheng Department of Otolaryngology
CE
Correspondence:
AC
SunYat-Sen Memorial Hospital of Sun Yat-Sen University, No. 107, Yuanjiang West Road, Guangzhou 510120, China
Phone number:
+86 2081332655
Fax number:
+86 2081332655
Email:
[email protected]
ACCEPTED MANUSCRIPT Abstract Objective: To evaluate the effect of the combination of balloon Eustachian tuboplasty
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(BET) and tympanic paracentesis (TP) on intractable chronic otitis media with effusion (COME).
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Methods: Ninety patients with intractable COME were included and randomly assigned to three groups: BET only (30 patients), BET+paracentesis (30 patients), and
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paracentesis only (30 patients). Otic endoscopic findings and tympanograms were recorded before the surgery and at the month 1, month 3, and month 6 follow-up evaluations.
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Results: Both the BET only and BET+paracentesis groups achieved better outcomes
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than the paracentesis group. The BET+paracentesis group exhibited better otic endoscopic scores than the BET only group (p<0.05) at 1 month post-operation.
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However, no significant difference was found at month 3 or month 6 post-operation.
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No significant difference in the tympanograms was observed between these two groups at month 1, month 3, or month 6 post-operation. The otic endoscopic sign scores improved from month 1 to month 6 in the BET only group and from month 1 to month 3 in the BET+paracentesis group. The conversion of type B tympanograms improved from month 1 to month 6 in the BET and BET+paracentesis groups but not in the paracentesis only group. Conclusions: Our results suggested that the combination of BET and TP was effective for intractable COME and can help shorten the recovery period for middle ear effusion.
ACCEPTED MANUSCRIPT Keywords: Balloon Dilation of the Eustachian Tube; Otitis Media with Effusion;
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Eustachian Tube Dysfunction; Tympanic Paracentesis
ACCEPTED MANUSCRIPT Introduction Otitis media with effusion (OME) is a common disorder in ENT clinics and is
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found mostly in children. In adults, OME has a low prevalence (approximately 0.55% to 1%) [1]. Although it does not induce speech disturbances in adults, the symptoms
SC
of aural fullness and hearing loss can significantly affect patient quality of life. Specifically, OME can cause tympanic atelectasis and even adhesive otitis media. It
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has been reported that OME can induce sensorial hearing loss in 14% of patients [1]. In adults, OME is commonly caused by nasopharyngeal obstruction. However, it has also been estimated that 46% of OME cases are caused by Eustachian tube
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dysfunction (ETD) [2]. For patients with OME caused by ETD, traditional treatment
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includes medicine such as antibiotics, nasal steroids, and decongestants, physical training such as a Valsalva maneuver, or a surgical process such as tympanic
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paracentesis (TP) or placement of a grommet [3]. However, traditional treatment has
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limited success in a portion of patients with intractable chronic otitis media with effusion (COME) likely due to ETD [4-6]. Recently, balloon Eustachian tuboplasty (BET) had emerged as a therapeutic option that has shown promising short-term results for ETD. Good outcomes for OME using BET have been reported [5-9]. However, most studies have not reported whether the OME patients enrolled had intractable COME. Some patients might be cured with only traditional treatment and not undergo BET. Regrettably, few studies have reported processes performed in addition to BET. Because reports have shown that middle ear effusion can affect normal ciliary function [10], we assumed that TP
ACCEPTED MANUSCRIPT could help to reduce the burden of the Eustachian tube (ET) and shorten the course of the disease.
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This study was performed to evaluate the effect of the combination of BET and TP on intractable COME.
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Materials and Methods
This study was a randomized, prospective, controlled trial conducted from April
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2013 to April 2015 in Sun Yat-sen Memorial Hospital. The study was approved by the Ethical Review Board of Sun Yat-sen Memorial Hospital, Sun Yat-sen University, China.
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Study population
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The study consisted of 90 adults (age range 20-52 years old) including 58 females and 32 males. All patients were diagnosed with single-side intractable COME that had
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been present for at least 6 months. All patients had been previously sequentially
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treated with traditional management techniques, such as medicine, physical training, TP, and grommet insertion, at least once. Patients were excluded if they had a physiological defect of the ear or nasopharynx, a high-resolution CT scan showed a missing bone between the ET and carotis interna, they had malformation of the ET or carotis interna, they had a tumor or aneurysm, or they could not attend follow-up evaluations. Study design The presence of a completed effusion of the middle ear was confirmed by otic endoscopy with tympanometry showing a type B tympanogram. The patients were
ACCEPTED MANUSCRIPT randomized into one of three groups as described in Table 1. The treatment protocols included BET only (group I), BET+paracentesis group II), and paracentesis only
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(group III). For group II, tympanic paracentesis was performed simultaneously with BET. For group I and group Ⅱ, only BET or tympanic paracentesis was performed
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respectively. Otic endoscopy and tympanometry were repeated at months 1, 3 and 6 in all participants. The otic endoscopy findings were scored as 0=no effusion, 1=air-fluid
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level or air bubbles, and 2=completed effusion. A normal tympanogram (type A) was determined by a normal trace with pressure between ±50. A sharp tracing with negative pressure of -200 indicated a type C tympanogram. Other values were
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determined to be type B tympanograms [11].
BET of the ET
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Table 1. Treatment groups
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The surgical technique of BET has been previously described in detail in other
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reports [6]. All procedures were performed under general anesthesia. A balloon catheter (Spiggle & Theis Medizintechnik GmbH, Diepenbroich, Germany) was inserted into the ET with endoscopic assistance (0 or 30-degree view angle). The balloon was inflated with sterile water to a pressure of 10 bars for 2 minutes. Statistical analysis The results were analyzed using SPSS 16.0. (Chicago, IL, USA). Comparisons between the groups were assessed by a one-way ANOVA for normally distributed data. An LSD test was used for multiple comparisons. A p value less than 0.05 was considered statistically significant.
ACCEPTED MANUSCRIPT Results Ninety subjects were enrolled and assigned to 3 groups (30 subjects in each). The
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demographic characteristics are shown in Table 2. No statistically significant differences were observed between the three treatment groups. All of the ears showed
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complete effusion (score of 2) and a type B tympanogram. Table 2 near here
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Otic endoscopic findings in the three groups
At month 1 post-operation, the otic endoscopic scores of groups I and II were better than those of group III (p<0.001, p<0.001, respectively). The scores of group II
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were better than those of group I (p<0.05). At months 3 and 6 post-operation, the otic
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endoscopic sign scores for groups I and II were also better than those of group III (Table 3). However, no significant difference was observed between group I and
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group II (p=0.094, p=0.492, respectively). Although at month 3, 80.0% (24/30) of the
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ears were free of effusion in group II. However, only 60.0% (18/30) were free of effusion in group I. Table 3 near here
Further analysis showed that in group I, the otic endoscopic scores improved from month 1 to month 6 (p<0.001, p<0.05, p<0.05, respectively). In group II, the otic endoscopic scores improved from month 1 to month 3 (p<0.001, p<0.05, respectively). However, no significant difference was found between month 3 and month 6. In group III, no significant differences were noted between the pre-operation and follow-up scores (Figure 1).
ACCEPTED MANUSCRIPT Figure 1 near here Tympanometry findings for the three groups
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At months 1, 3, and 6 post-operation, a greater proportion of type A tympanograms were found in groups I and II than in group III (Table 4). However,
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significant differences were present between groups I and II at month 1, month 3, or month 6 post-operation (p=0.103, p=0.111, p=0.492, respectively).
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Table 4 near here
A further analysis showed that in groups I and II, the tympanogram improved from month 1 to month 6. However, in group III, no significant differences were
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observed from the pre-operation to the follow-up tympanogram (Figure 2).
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Figure 2 near here
The management of COME has long been a challenge. Medicine and physical
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training usually show low efficacy in the treatment of COME [4], which usually then
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develops into intractable COME. Because COME causes long-term negative pressure, which might cause the fiber layer to become thin or even absent, tympanic membrane atelectasis occurs. Once atelectasis occurs, eardrum grommet insertion is more prone to detachment. This can cause damage to the middle ear and might induce hearing loss or even adhesive otitis media, tympanic atelectasis, and cholesteatoma [12]. Many methods have been used for the treatment of OME, but with little success [4]. For example, the use of an intranasal steroid spray for 6 weeks failed to show any difference vs. a placebo control in a randomized, double-blinded trial. Neither an antimicrobial nor a decongestant treatment showed an advantage compared to a
ACCEPTED MANUSCRIPT placebo [13]. Even TP or grommet insertion showed limited efficacy [4]. COME has long been thought to be related to poor ET function. Traditional methods cannot
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directly improve ET function. Thus, this may be reason for the low efficacy of traditional treatments.
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Recently, it had been reported that BET can be effective in improving ET function. For poor ET function occurring mainly in the cartilaginous portion [14],
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BET can expand the cartilaginous part to approximately 457% without producing any serious complications [15] in a cadaver model. In clinical trials, Poe et al. [8] reported 11 cases of long-term OME with BET (12 atm for 1 min) and found ET function
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improvement in all cases. Patients were able to self-insufflate via a Valsalva maneuver
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post-operation. Entire tympanic atelectasis can be restored. Silvia [7] also reported similar encouraging outcomes in 41 OME patients with follow-up durations of 1.5 to
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4.2 years. In general, the efficacy rate of BET on OME has been reported to be
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approximately 80% to 100% [7-9, 16-18]. Although previous reports have shown encouraging results of BET for OME, the efficacy of BET on intractable OME remains unclear. Moreover, in clinical practice, we noticed that additional paracentesis can help relieve ear discomfort quickly after BET surgery. In our present study, we aimed to evaluate the effectiveness of BET and the necessity of paracentesis. Compared to traditional paracentesis, our study showed that both the BET and BET+paracentesis groups had significantly better improvements in the otic endoscopic findings and tympanograms regarding the treatment of intractable COME.
ACCEPTED MANUSCRIPT The efficacy rate for the BET only group was approximately 80%, which was slightly lower than that in previous reports [7-9, 16-18]. This might have occurred because all
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patients in the present study had intractable COME, which might be affected by other factors, such as worsening ET function.
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Compared with the BET only group, greater improvements in the otic endoscopic sign scores at month 1 post-operation were found in the BET+paracentesis
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group. At months 3 and months 6 post-operation, the BET+paracentesis group showed greater improvement than the BET only group, but no significant difference was found. Although paracentesis only showed low efficacy, our results indicated that
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BET with TP can help to shorten recovery time and might provide a better outcome in
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approximately 86.6% of patients at 6 months post-operation. This may occur because middle ear effusion can inhibit the ciliary function [10]. Although BET can enlarge
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the ET lumen, the ciliary function cannot recover quickly due to micro-trauma
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incurred during the operation. Paracentesis can help to relieve the ciliary burden and be helpful during recovery. Although significant improvements in tympanograms were found in the BET and BET+paracentesis groups compared to the paracentesis only group, no significant differences were observed between the BET and BET+paracentesis groups at months 1, 3 or 6 post-operation. It was confirmed that the tympanogram was closely related to ET function. Our result further confirmed that BET can improve the ET function. However, paracentesis did not contribute to the improvement of ET function. The mechanism by which BET ameliorates intractable COME remains unclear.
ACCEPTED MANUSCRIPT Microfractures of the cartilaginous ET [15] and loosening of the corresponding connective tissues have been noted to be caused by the BET and were regarded as a
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possible explanation [15, 19] because as this would decrease the minimal opening pressure and allow the ET to be more easily opened. This would enable recovery of
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ET function. A recent report [19] indicated that lymphocytes and lymphocytic follicles were effectively crushed by BET and replaced by thinner fibrous scar tissue. Thus, a
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reduction of the inflammatory burden may contribute to the clinical improvement of ET function. Conclusions
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This study demonstrated that the combination of BET and TP was effective for
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the treatment of intractable COME. The results suggest that one possible benefit of BET is improvement of ET function. Additional TP helped reduce the fluid burden of
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the ET and shorten the recovery time, which could lead to a slightly increased
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positive outcome.
ACCEPTED MANUSCRIPT References [1] Harada T, Yamasoba T, Yagi M. Sensorineural hearing loss associated with otitis
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media with effusion. ORL J Otorhinolaryngol Relat Spec 1992;54:61-5. [2] Iwano T, Kinoshita T, Hamada E, Doi T, Ushiro K, Kumazawa T. Otitis media
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with effusion and eustachian tube dysfunction in adults and children. Acta Otolaryngol Suppl 1993;500:66-9.
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[3] Adil E, Poe D. What is the full range of medical and surgical treatments available for patients with Eustachian tube dysfunction? Curr Opin Otolaryngol Head Neck Surg 2014;22:8-15.
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[4] Daniel M, Kamani T, El-Shunnar S, Jaberoo MC, Harrison A, Yalamanchili S, et al.
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National Institute for Clinical Excellence guidelines on the surgical management of otitis media with effusion: are they being followed and have they changed practice?
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Int J Pediatr Otorhinolaryngol 2013;77:54-8.
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[5] Poe D. In reference to balloon dilatation Eustachian tuboplasty: a clinical study. Laryngoscope 2011;121:908. [6] Ockermann T, Reineke U, Upile T, Ebmeyer J, Sudhoff HH. Balloon dilatation eustachian tuboplasty: a clinical study. Laryngoscope 2010;120:1411-6. [7] Silvola J, Kivekas I, Poe DS. Balloon dilation of the cartilaginous portion of the Eustachian tube. Otolaryngol Head Neck Surg 2014;151:125-30. [8] Poe DS, Silvola J, Pyykko I. Balloon dilation of the cartilaginous eustachian tube. Otolaryngol Head Neck Surg 2011;144:563-9. [9] Catalano PJ, Jonnalagadda S, Yu VM. Balloon catheter dilatation of Eustachian
ACCEPTED MANUSCRIPT tube: a preliminary study. Otol Neurotol 2012;33:1549-52. [10] Sade J, Ar A. Middle ear and auditory tube: middle ear clearance, gas exchange,
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and pressure regulation. Otolaryngol Head Neck Surg 1997;116:499-524. [11] Ertugay CK, Cingi C, Yaz A, San T, Ulusoy S, Erdogmus N, et al. Effect of
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combination of montelukast and levocetirizine on otitis media with effusion: a prospective, placebo-controlled trial. Acta Otolaryngol 2013;133:1266-72.
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[12] Sade J, Fuchs C. Secretory otitis media in adults: II. The role of mastoid pneumatization as a prognostic factor. Ann Otol Rhinol Laryngol 1997;106:37-40. [13] Williamson I, Benge S, Barton S, Petrou S, Letley L, Fasey N, et al. A
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double-blind randomised placebo-controlled trial of topical intranasal corticosteroids
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in 4- to 11-year-old children with persistent bilateral otitis media with effusion in primary care. Health Technol Assess 2009;13:1-144.
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[14] Ockermann T, Reineke U, Upile T, Ebmeyer J, Sudhoff HH. Balloon dilation
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eustachian tuboplasty: a feasibility study. Otol Neurotol 2010;31:1100-3. [15] Poe DS, Hanna BM. Balloon dilation of the cartilaginous portion of the eustachian tube: initial safety and feasibility analysis in a cadaver model. Am J Otolaryngol 2011;32:115-23. [16] Gurtler N, Husner A, Flurin H. Balloon dilation of the Eustachian tube: early outcome analysis. Otol Neurotol 2015;36:437-43. [17] Jurkiewicz D, Bien D, Szczygielski K, Kantor I. Clinical evaluation of balloon dilation Eustachian tuboplasty in the Eustachian tube dysfunction. Eur Arch Otorhinolaryngol 2013;270:1157-60.
ACCEPTED MANUSCRIPT [18] McCoul ED, Anand VK. Eustachian tube balloon dilation surgery. Int Forum Allergy Rhinol 2012;2:191-8.
Histopathology
of
balloon-dilation
Eustachian
tuboplasty.
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2015;125:436-41.
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[19] Kivekas I, Chao WC, Faquin W, Hollowell M, Silvola J, Rasooly T, et al. Laryngoscope
ACCEPTED MANUSCRIPT Table 1. Treatment groups treatment
I
BET only
II
BET+ paracentisis
III
paracentisis
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BET: Balloon Eustachian tuboplasty
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Group no.
ACCEPTED MANUSCRIPT Table 2. Demographic characteristics of the patients in three groups Group Group I(n=30)
Group II(n=30)
p
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III(n=30) 10/20
0.536*
36(22-48)
0.523
21(8-34)
0.617
18/12
16/14
0.589*
2(1-5)
2(1-4)
0.342*
13/17
9/21
Age (years)
34(20-52) ∆
38(26-51)
COME Duration(Months)
24(6-41) ∆
26(8-42)
Ears(L/R)
14/16
N. of TP previously
2(1-4) ∆
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Male/female
#TP: Tympanic Paracentisis; ∆: Media(range); COME: chronic otitis media with effusion; *
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:Kruskal-Wallis H test
ACCEPTED MANUSCRIPT Table 3. Otic endoscopic sign scores pre- and post- operantion Group I(n=30)
Group III(n=30)
0
p* 0(0.0 0(0.0 30(10 0(0.0 ) ) 0.0) ) 10(3 12(4 8(26. 18(6 7) 3.3) 0.0) 0.0) 18(6 6(20. 6(20. 24(8 0) 0) 0.0) 0.0) 24(8 2(6.7 4(13. 26(8 ) 3) 0.0) 6.6)
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*: Kruskal-Wallis H tests
1
2
0
1
2
0(0. 0) 6(2 0.0) 4(1 3.3) 2(6. 7)
30(10 0.0) 6(20. 0) 2(6.7 ) 2(6.7 )
0(0 .0) 1(3 .3) 2(6 .7) 2(6 .7)
0(0. 0) 3(1 0.0) 2(6. 7) 2(6. 7)
30(10 0.0) 26(86 .7) 26(86 .6) 26(6. 7)
T
2
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1
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0
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Endoscopy scale pre-operatio n,No.(%) Month 1, No.(%) Month 3, No.(%) Month 6, No.(%)
Group II(n=30)
<0. 001 <0. 001 <0. 001
ACCEPTED MANUSCRIPT Table 4 Tympanometry finding during the follow-up Group II(n=30)
p* A
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*: Kruskal-Wallis H tests
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Tympanogra A C B A C B m pre-operation 0(0.0 0(0. 30(10 0(0.0 0(0. 30(10 ,No.(%) ) 0) 0.0) ) 0) 0.0) Month 1, 7(23. 6(20 17(56 13(4 7(23 10(33 No.(%) .0) .7) .3) .4) 3) 3.3) Month 3, 16(5 5(16 9(30. 22(7 3(10 5(16. No.(%) .7) 0) .0) 7) 3.3) 3.3) Month 6, 24(8 1(3. 5(16. 25(8 2(6. 3(10. No.(%) 3) 7) 7) 0) 0) 3.3)
Group III(n=30) C
B
0(0 .0) 2(6 .7) 2(6 .7) 2(7 )
30(10 0.0) 27(90 .0) 27(90 .0) 26(87 )
T
Group I(n=30)
0(0 .0) 1(3 .3) 1(3 .3) 2(7 )
<0. 001 <0. 001 <0. 001
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ACCEPTED MANUSCRIPT
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ACCEPTED MANUSCRIPT
S0196-0709(16)30001-1 doi: 10.1016/j.amjoto.2016.03.006 YAJOT 1704
To appear in:
American Journal of Otolaryngology–Head and Neck Medicine and Surgery
Received date:
24 January 2016
Please cite this article as: Liang Maojin, Xiong Hao, Cai Yuexin, Chen Yuebo, Zhang Zhigang, Chen Suijun, Xu Yaodong, Ou Yongkang, Yang Haidi, Zheng Yiqing, Effect of the Combination of Balloon Eustachian Tuboplasty and Tympanic Paracentesis on Intractable Chronic Otitis Media with Effusion, American Journal of Otolaryngology–Head and Neck Medicine and Surgery (2016), doi: 10.1016/j.amjoto.2016.03.006
This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
ACCEPTED MANUSCRIPT Effect of the Combination of Balloon Eustachian Tuboplasty and Tympanic
RI P
T
Paracentesis on Intractable Chronic Otitis Media with Effusion
Maojin Lianga,b,c, MD, Hao Xionga,b,c, PhD, Yuexin Caia,b,c, Yuebo Chena,b,c, MD,
SC
Zhigang Zhanga,b,c, MD, Suijun Chena,b,c, MD, Yaodong Xua,b,c, MD, Yongkang Oua,b,c, MD, Haidi Yanga,b,c, PhD, Yiqing Zhenga,b,c*, MD
Department of Otolaryngology, Sun Yat-sen Memorial Hospital, Sun Yat-sen
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a
University, China
Institute of Hearing and Speech-Language Science, Sun Yat-sen University, China
c
Department of Hearing and Speech-Language Science, Xinhua College, Sun Yat-sen
ED
b
Address
PT
University, China
for Yiqing Zheng Department of Otolaryngology
CE
Correspondence:
AC
SunYat-Sen Memorial Hospital of Sun Yat-Sen University, No. 107, Yuanjiang West Road, Guangzhou 510120, China
Phone number:
+86 2081332655
Fax number:
+86 2081332655
Email:
[email protected]
ACCEPTED MANUSCRIPT Abstract Objective: To evaluate the effect of the combination of balloon Eustachian tuboplasty
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T
(BET) and tympanic paracentesis (TP) on intractable chronic otitis media with effusion (COME).
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Methods: Ninety patients with intractable COME were included and randomly assigned to three groups: BET only (30 patients), BET+paracentesis (30 patients), and
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paracentesis only (30 patients). Otic endoscopic findings and tympanograms were recorded before the surgery and at the month 1, month 3, and month 6 follow-up evaluations.
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Results: Both the BET only and BET+paracentesis groups achieved better outcomes
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than the paracentesis group. The BET+paracentesis group exhibited better otic endoscopic scores than the BET only group (p<0.05) at 1 month post-operation.
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However, no significant difference was found at month 3 or month 6 post-operation.
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No significant difference in the tympanograms was observed between these two groups at month 1, month 3, or month 6 post-operation. The otic endoscopic sign scores improved from month 1 to month 6 in the BET only group and from month 1 to month 3 in the BET+paracentesis group. The conversion of type B tympanograms improved from month 1 to month 6 in the BET and BET+paracentesis groups but not in the paracentesis only group. Conclusions: Our results suggested that the combination of BET and TP was effective for intractable COME and can help shorten the recovery period for middle ear effusion.
ACCEPTED MANUSCRIPT Keywords: Balloon Dilation of the Eustachian Tube; Otitis Media with Effusion;
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CE
PT
ED
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Eustachian Tube Dysfunction; Tympanic Paracentesis
ACCEPTED MANUSCRIPT Introduction Otitis media with effusion (OME) is a common disorder in ENT clinics and is
RI P
T
found mostly in children. In adults, OME has a low prevalence (approximately 0.55% to 1%) [1]. Although it does not induce speech disturbances in adults, the symptoms
SC
of aural fullness and hearing loss can significantly affect patient quality of life. Specifically, OME can cause tympanic atelectasis and even adhesive otitis media. It
MA NU
has been reported that OME can induce sensorial hearing loss in 14% of patients [1]. In adults, OME is commonly caused by nasopharyngeal obstruction. However, it has also been estimated that 46% of OME cases are caused by Eustachian tube
ED
dysfunction (ETD) [2]. For patients with OME caused by ETD, traditional treatment
PT
includes medicine such as antibiotics, nasal steroids, and decongestants, physical training such as a Valsalva maneuver, or a surgical process such as tympanic
CE
paracentesis (TP) or placement of a grommet [3]. However, traditional treatment has
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limited success in a portion of patients with intractable chronic otitis media with effusion (COME) likely due to ETD [4-6]. Recently, balloon Eustachian tuboplasty (BET) had emerged as a therapeutic option that has shown promising short-term results for ETD. Good outcomes for OME using BET have been reported [5-9]. However, most studies have not reported whether the OME patients enrolled had intractable COME. Some patients might be cured with only traditional treatment and not undergo BET. Regrettably, few studies have reported processes performed in addition to BET. Because reports have shown that middle ear effusion can affect normal ciliary function [10], we assumed that TP
ACCEPTED MANUSCRIPT could help to reduce the burden of the Eustachian tube (ET) and shorten the course of the disease.
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This study was performed to evaluate the effect of the combination of BET and TP on intractable COME.
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Materials and Methods
This study was a randomized, prospective, controlled trial conducted from April
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2013 to April 2015 in Sun Yat-sen Memorial Hospital. The study was approved by the Ethical Review Board of Sun Yat-sen Memorial Hospital, Sun Yat-sen University, China.
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Study population
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The study consisted of 90 adults (age range 20-52 years old) including 58 females and 32 males. All patients were diagnosed with single-side intractable COME that had
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been present for at least 6 months. All patients had been previously sequentially
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treated with traditional management techniques, such as medicine, physical training, TP, and grommet insertion, at least once. Patients were excluded if they had a physiological defect of the ear or nasopharynx, a high-resolution CT scan showed a missing bone between the ET and carotis interna, they had malformation of the ET or carotis interna, they had a tumor or aneurysm, or they could not attend follow-up evaluations. Study design The presence of a completed effusion of the middle ear was confirmed by otic endoscopy with tympanometry showing a type B tympanogram. The patients were
ACCEPTED MANUSCRIPT randomized into one of three groups as described in Table 1. The treatment protocols included BET only (group I), BET+paracentesis group II), and paracentesis only
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(group III). For group II, tympanic paracentesis was performed simultaneously with BET. For group I and group Ⅱ, only BET or tympanic paracentesis was performed
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respectively. Otic endoscopy and tympanometry were repeated at months 1, 3 and 6 in all participants. The otic endoscopy findings were scored as 0=no effusion, 1=air-fluid
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level or air bubbles, and 2=completed effusion. A normal tympanogram (type A) was determined by a normal trace with pressure between ±50. A sharp tracing with negative pressure of -200 indicated a type C tympanogram. Other values were
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determined to be type B tympanograms [11].
BET of the ET
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Table 1. Treatment groups
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The surgical technique of BET has been previously described in detail in other
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reports [6]. All procedures were performed under general anesthesia. A balloon catheter (Spiggle & Theis Medizintechnik GmbH, Diepenbroich, Germany) was inserted into the ET with endoscopic assistance (0 or 30-degree view angle). The balloon was inflated with sterile water to a pressure of 10 bars for 2 minutes. Statistical analysis The results were analyzed using SPSS 16.0. (Chicago, IL, USA). Comparisons between the groups were assessed by a one-way ANOVA for normally distributed data. An LSD test was used for multiple comparisons. A p value less than 0.05 was considered statistically significant.
ACCEPTED MANUSCRIPT Results Ninety subjects were enrolled and assigned to 3 groups (30 subjects in each). The
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demographic characteristics are shown in Table 2. No statistically significant differences were observed between the three treatment groups. All of the ears showed
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complete effusion (score of 2) and a type B tympanogram. Table 2 near here
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Otic endoscopic findings in the three groups
At month 1 post-operation, the otic endoscopic scores of groups I and II were better than those of group III (p<0.001, p<0.001, respectively). The scores of group II
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were better than those of group I (p<0.05). At months 3 and 6 post-operation, the otic
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endoscopic sign scores for groups I and II were also better than those of group III (Table 3). However, no significant difference was observed between group I and
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group II (p=0.094, p=0.492, respectively). Although at month 3, 80.0% (24/30) of the
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ears were free of effusion in group II. However, only 60.0% (18/30) were free of effusion in group I. Table 3 near here
Further analysis showed that in group I, the otic endoscopic scores improved from month 1 to month 6 (p<0.001, p<0.05, p<0.05, respectively). In group II, the otic endoscopic scores improved from month 1 to month 3 (p<0.001, p<0.05, respectively). However, no significant difference was found between month 3 and month 6. In group III, no significant differences were noted between the pre-operation and follow-up scores (Figure 1).
ACCEPTED MANUSCRIPT Figure 1 near here Tympanometry findings for the three groups
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At months 1, 3, and 6 post-operation, a greater proportion of type A tympanograms were found in groups I and II than in group III (Table 4). However,
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significant differences were present between groups I and II at month 1, month 3, or month 6 post-operation (p=0.103, p=0.111, p=0.492, respectively).
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Table 4 near here
A further analysis showed that in groups I and II, the tympanogram improved from month 1 to month 6. However, in group III, no significant differences were
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observed from the pre-operation to the follow-up tympanogram (Figure 2).
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Figure 2 near here
The management of COME has long been a challenge. Medicine and physical
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training usually show low efficacy in the treatment of COME [4], which usually then
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develops into intractable COME. Because COME causes long-term negative pressure, which might cause the fiber layer to become thin or even absent, tympanic membrane atelectasis occurs. Once atelectasis occurs, eardrum grommet insertion is more prone to detachment. This can cause damage to the middle ear and might induce hearing loss or even adhesive otitis media, tympanic atelectasis, and cholesteatoma [12]. Many methods have been used for the treatment of OME, but with little success [4]. For example, the use of an intranasal steroid spray for 6 weeks failed to show any difference vs. a placebo control in a randomized, double-blinded trial. Neither an antimicrobial nor a decongestant treatment showed an advantage compared to a
ACCEPTED MANUSCRIPT placebo [13]. Even TP or grommet insertion showed limited efficacy [4]. COME has long been thought to be related to poor ET function. Traditional methods cannot
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directly improve ET function. Thus, this may be reason for the low efficacy of traditional treatments.
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Recently, it had been reported that BET can be effective in improving ET function. For poor ET function occurring mainly in the cartilaginous portion [14],
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BET can expand the cartilaginous part to approximately 457% without producing any serious complications [15] in a cadaver model. In clinical trials, Poe et al. [8] reported 11 cases of long-term OME with BET (12 atm for 1 min) and found ET function
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improvement in all cases. Patients were able to self-insufflate via a Valsalva maneuver
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post-operation. Entire tympanic atelectasis can be restored. Silvia [7] also reported similar encouraging outcomes in 41 OME patients with follow-up durations of 1.5 to
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4.2 years. In general, the efficacy rate of BET on OME has been reported to be
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approximately 80% to 100% [7-9, 16-18]. Although previous reports have shown encouraging results of BET for OME, the efficacy of BET on intractable OME remains unclear. Moreover, in clinical practice, we noticed that additional paracentesis can help relieve ear discomfort quickly after BET surgery. In our present study, we aimed to evaluate the effectiveness of BET and the necessity of paracentesis. Compared to traditional paracentesis, our study showed that both the BET and BET+paracentesis groups had significantly better improvements in the otic endoscopic findings and tympanograms regarding the treatment of intractable COME.
ACCEPTED MANUSCRIPT The efficacy rate for the BET only group was approximately 80%, which was slightly lower than that in previous reports [7-9, 16-18]. This might have occurred because all
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patients in the present study had intractable COME, which might be affected by other factors, such as worsening ET function.
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Compared with the BET only group, greater improvements in the otic endoscopic sign scores at month 1 post-operation were found in the BET+paracentesis
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group. At months 3 and months 6 post-operation, the BET+paracentesis group showed greater improvement than the BET only group, but no significant difference was found. Although paracentesis only showed low efficacy, our results indicated that
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BET with TP can help to shorten recovery time and might provide a better outcome in
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approximately 86.6% of patients at 6 months post-operation. This may occur because middle ear effusion can inhibit the ciliary function [10]. Although BET can enlarge
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the ET lumen, the ciliary function cannot recover quickly due to micro-trauma
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incurred during the operation. Paracentesis can help to relieve the ciliary burden and be helpful during recovery. Although significant improvements in tympanograms were found in the BET and BET+paracentesis groups compared to the paracentesis only group, no significant differences were observed between the BET and BET+paracentesis groups at months 1, 3 or 6 post-operation. It was confirmed that the tympanogram was closely related to ET function. Our result further confirmed that BET can improve the ET function. However, paracentesis did not contribute to the improvement of ET function. The mechanism by which BET ameliorates intractable COME remains unclear.
ACCEPTED MANUSCRIPT Microfractures of the cartilaginous ET [15] and loosening of the corresponding connective tissues have been noted to be caused by the BET and were regarded as a
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possible explanation [15, 19] because as this would decrease the minimal opening pressure and allow the ET to be more easily opened. This would enable recovery of
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ET function. A recent report [19] indicated that lymphocytes and lymphocytic follicles were effectively crushed by BET and replaced by thinner fibrous scar tissue. Thus, a
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reduction of the inflammatory burden may contribute to the clinical improvement of ET function. Conclusions
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This study demonstrated that the combination of BET and TP was effective for
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the treatment of intractable COME. The results suggest that one possible benefit of BET is improvement of ET function. Additional TP helped reduce the fluid burden of
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the ET and shorten the recovery time, which could lead to a slightly increased
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positive outcome.
ACCEPTED MANUSCRIPT References [1] Harada T, Yamasoba T, Yagi M. Sensorineural hearing loss associated with otitis
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media with effusion. ORL J Otorhinolaryngol Relat Spec 1992;54:61-5. [2] Iwano T, Kinoshita T, Hamada E, Doi T, Ushiro K, Kumazawa T. Otitis media
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with effusion and eustachian tube dysfunction in adults and children. Acta Otolaryngol Suppl 1993;500:66-9.
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[3] Adil E, Poe D. What is the full range of medical and surgical treatments available for patients with Eustachian tube dysfunction? Curr Opin Otolaryngol Head Neck Surg 2014;22:8-15.
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[4] Daniel M, Kamani T, El-Shunnar S, Jaberoo MC, Harrison A, Yalamanchili S, et al.
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National Institute for Clinical Excellence guidelines on the surgical management of otitis media with effusion: are they being followed and have they changed practice?
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Int J Pediatr Otorhinolaryngol 2013;77:54-8.
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[5] Poe D. In reference to balloon dilatation Eustachian tuboplasty: a clinical study. Laryngoscope 2011;121:908. [6] Ockermann T, Reineke U, Upile T, Ebmeyer J, Sudhoff HH. Balloon dilatation eustachian tuboplasty: a clinical study. Laryngoscope 2010;120:1411-6. [7] Silvola J, Kivekas I, Poe DS. Balloon dilation of the cartilaginous portion of the Eustachian tube. Otolaryngol Head Neck Surg 2014;151:125-30. [8] Poe DS, Silvola J, Pyykko I. Balloon dilation of the cartilaginous eustachian tube. Otolaryngol Head Neck Surg 2011;144:563-9. [9] Catalano PJ, Jonnalagadda S, Yu VM. Balloon catheter dilatation of Eustachian
ACCEPTED MANUSCRIPT tube: a preliminary study. Otol Neurotol 2012;33:1549-52. [10] Sade J, Ar A. Middle ear and auditory tube: middle ear clearance, gas exchange,
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and pressure regulation. Otolaryngol Head Neck Surg 1997;116:499-524. [11] Ertugay CK, Cingi C, Yaz A, San T, Ulusoy S, Erdogmus N, et al. Effect of
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combination of montelukast and levocetirizine on otitis media with effusion: a prospective, placebo-controlled trial. Acta Otolaryngol 2013;133:1266-72.
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[12] Sade J, Fuchs C. Secretory otitis media in adults: II. The role of mastoid pneumatization as a prognostic factor. Ann Otol Rhinol Laryngol 1997;106:37-40. [13] Williamson I, Benge S, Barton S, Petrou S, Letley L, Fasey N, et al. A
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double-blind randomised placebo-controlled trial of topical intranasal corticosteroids
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in 4- to 11-year-old children with persistent bilateral otitis media with effusion in primary care. Health Technol Assess 2009;13:1-144.
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[14] Ockermann T, Reineke U, Upile T, Ebmeyer J, Sudhoff HH. Balloon dilation
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eustachian tuboplasty: a feasibility study. Otol Neurotol 2010;31:1100-3. [15] Poe DS, Hanna BM. Balloon dilation of the cartilaginous portion of the eustachian tube: initial safety and feasibility analysis in a cadaver model. Am J Otolaryngol 2011;32:115-23. [16] Gurtler N, Husner A, Flurin H. Balloon dilation of the Eustachian tube: early outcome analysis. Otol Neurotol 2015;36:437-43. [17] Jurkiewicz D, Bien D, Szczygielski K, Kantor I. Clinical evaluation of balloon dilation Eustachian tuboplasty in the Eustachian tube dysfunction. Eur Arch Otorhinolaryngol 2013;270:1157-60.
ACCEPTED MANUSCRIPT [18] McCoul ED, Anand VK. Eustachian tube balloon dilation surgery. Int Forum Allergy Rhinol 2012;2:191-8.
Histopathology
of
balloon-dilation
Eustachian
tuboplasty.
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2015;125:436-41.
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[19] Kivekas I, Chao WC, Faquin W, Hollowell M, Silvola J, Rasooly T, et al. Laryngoscope
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I
BET only
II
BET+ paracentisis
III
paracentisis
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BET: Balloon Eustachian tuboplasty
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Group no.
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Group II(n=30)
p
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III(n=30) 10/20
0.536*
36(22-48)
0.523
21(8-34)
0.617
18/12
16/14
0.589*
2(1-5)
2(1-4)
0.342*
13/17
9/21
Age (years)
34(20-52) ∆
38(26-51)
COME Duration(Months)
24(6-41) ∆
26(8-42)
Ears(L/R)
14/16
N. of TP previously
2(1-4) ∆
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Male/female
#TP: Tympanic Paracentisis; ∆: Media(range); COME: chronic otitis media with effusion; *
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:Kruskal-Wallis H test
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Group III(n=30)
0
p* 0(0.0 0(0.0 30(10 0(0.0 ) ) 0.0) ) 10(3 12(4 8(26. 18(6 7) 3.3) 0.0) 0.0) 18(6 6(20. 6(20. 24(8 0) 0) 0.0) 0.0) 24(8 2(6.7 4(13. 26(8 ) 3) 0.0) 6.6)
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*: Kruskal-Wallis H tests
1
2
0
1
2
0(0. 0) 6(2 0.0) 4(1 3.3) 2(6. 7)
30(10 0.0) 6(20. 0) 2(6.7 ) 2(6.7 )
0(0 .0) 1(3 .3) 2(6 .7) 2(6 .7)
0(0. 0) 3(1 0.0) 2(6. 7) 2(6. 7)
30(10 0.0) 26(86 .7) 26(86 .6) 26(6. 7)
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2
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Endoscopy scale pre-operatio n,No.(%) Month 1, No.(%) Month 3, No.(%) Month 6, No.(%)
Group II(n=30)
<0. 001 <0. 001 <0. 001
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p* A
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*: Kruskal-Wallis H tests
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Tympanogra A C B A C B m pre-operation 0(0.0 0(0. 30(10 0(0.0 0(0. 30(10 ,No.(%) ) 0) 0.0) ) 0) 0.0) Month 1, 7(23. 6(20 17(56 13(4 7(23 10(33 No.(%) .0) .7) .3) .4) 3) 3.3) Month 3, 16(5 5(16 9(30. 22(7 3(10 5(16. No.(%) .7) 0) .0) 7) 3.3) 3.3) Month 6, 24(8 1(3. 5(16. 25(8 2(6. 3(10. No.(%) 3) 7) 7) 0) 0) 3.3)
Group III(n=30) C
B
0(0 .0) 2(6 .7) 2(6 .7) 2(7 )
30(10 0.0) 27(90 .0) 27(90 .0) 26(87 )
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Group I(n=30)
0(0 .0) 1(3 .3) 1(3 .3) 2(7 )
<0. 001 <0. 001 <0. 001
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