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Otology-02

Comment on Laryngoscope, 129:222–228, 2019

耳咽管成型手術治療耳咽管開放症的十二個月手術成效

Twelve-Month Outcomes of Eustachian Tube Procedures for Management of Patulous Eustachian Tube Dysfunction

Bryan K. Ward, MD; Wei-Chieh Chao, MD; Godwin Abiola, BA; Kosuke Kawai, ScD; Yehia Ashry, MD; TaliRasooly, BA; Dennis S. Poe, MD, PhD

基隆長庚醫院 趙偉傑醫師

Commentary耳咽管開放症 (PETD) 被認為是耳咽管外前側管壁粘膜凹陷缺失而產生閉鎖不全的狀況，耳咽管外側壁由

彎曲的軟骨、Ostmann’s fat 以及咽帆張肌 (TVP) 形成微突的構造在耳咽管關閉時擋住管徑。病人時常覺得身體

內部的聲音 ( 如語音、呼吸聲 ) 擴大或扭曲了感到不適，症狀為間歇性的，會在運動時或說話多時容易發生，

症狀會因低頭或躺下而得到緩解。診斷上除了症狀上的描述之外，病人用力呼吸時可以觀察到耳膜因呼吸而內

外移動。

耳咽管開放症沒有標準的治療方式，手術治療著重於減少耳膜因呼吸位移產生的不適與呼吸聲如置放通氣

管或是在中耳端耳咽管置放阻塞物，也有在鼻咽端置放組塞物或是局部黏膜下注射或填補來彌補缺口，最後手

段為將耳咽管完全縫合來趕善症狀。多數方法都有短期效益，但沒有長期結果與比較，本文主要將多種經鼻咽

耳咽管成型手術 12 個月的預後加以整理探討。

作者以 PET 的診斷碼搜尋分析 2004 年至 2016 年，波士頓兒童醫院的醫療記錄，得到 340 為診斷為耳咽

管開放症的病人，調閱病歷後得到 96 位接受耳咽管開放症手術的案例並依據手術方式分為四組：耳咽管置入

由骨蠟塞後之靜脈導管 (shim) 組 (115 術次 )、將磷酸鈣骨水泥打入耳咽管管粘膜下 (38 術次 )、其他將耳咽管

管徑縮減的耳咽管成型術 (PETR) (77 術次 )，耳咽管完全縫合阻斷 (11 術次 )，一個人兩側耳咽管可能接受多

次手術，同側兩次手術以上者則定義為前次手術失敗，表一為病人的基本資料與症狀分佈，這是現有文獻最大

人數的統計資料，可作為病人症狀上與性別年齡的參考文獻。

所有的術式平均症狀緩解時間為 5.5 個月，相較於導管置放 (shim) 組，粘膜下注射與黏膜下管徑縮減

(PETR) 兩組的 12 個月內失敗率較高，HR：2.18，HR 1.61，11 個接受耳咽管完全縫合阻斷的耳朵症狀緩解

都超過 12 個月，導管置放組的失敗率為 24.6%，這兩種術式比較能夠提供長期的症狀控制，然而導管置放組

有 52.2%，完全縫合阻斷組有 81.8% 的機會需要裝置中耳通氣管來維持中耳換氣功能。在 12 個月症狀維持正

常 ( 存活率 ) 分析個組比較皆達統計學意義。

有接近 75% 的病耳接受的第一次手術為導管置放，這個方式技術上相對簡單快速，在 12 個月控制症狀的

結果也超過 75% 存活，所以是合理的第一次術式的選擇，但因為管徑選擇上的差異 ( 通常在 16 G 或 14 G 的

靜脈導管做選擇 ) 有 12% 的機會滑脫，其它文獻上，也有使用縫合來預防滑脫，或是從耳膜切開中耳腔放入，

相較於經口內視鏡縫合或縮減管壁的術式而言，技術上簡單得多也因此造成的手術時間與口咽腔懸甕垂的傷害

少得多。每個病耳平均接受的手術次數為 3 次，而且不包含之前接受過的處置，因此可知耳咽管開放症手術上

仍無一個可靠的標準與完美術式，而且以筆者親身經驗而言這些手術畢竟是以較小的不適換取病人原本的較大

問題，在術前需要更完整的溝通。

關鍵字：耳咽管開放症，耳咽管，耳內回音

73

Twelve-Month Outcomes of Eustachian Tube Procedures for

Management of Patulous Eustachian Tube Dysfunction

Bryan K. Ward, MD; Wei-Chieh Chao, MD; Godwin Abiola, BA; Kosuke Kawai, ScD; Yehia Ashry, MD;

Tali Rasooly, BA; Dennis S. Poe, MD, PhD

Objective: To determine the 12-month effectiveness of transnasal–transoral endoscopic surgical procedures for eliminat-ing symptoms of patulous Eustachian tube dysfunction (PETD).

Study Design: Retrospective chart reviewMethods: Patients with medically refractory PETD underwent one of the following procedures: 1) shim (catheter) inser-

tion, 2) calcium hydroxyapatite injection, 3) patulous Eustachian tube (ET) reconstruction, or 4) obliteration of the ET lumen.Time to recurrence of any PETD symptoms was recorded, and success was determined as complete symptom resolution at12 months. The frailty model, an extension of the Cox proportional hazards model, was used for the survival analysis.

Results: A total of 241 procedures were performed in 80 patients. Median duration of symptom relief after surgery was5.0 months (interquartile range [IQR]: 1.1–15.5 months) and varied by procedure type, ranging from 3.0 months (IQR:0.7–7.0 months) for calcium hydroxyapatite injection to 20.6 months (3.4–35.9 months) for obliteration. Compared to shiminsertion, the risk of 12-month failure was significantly higher for calcium hydroxyapatite injection (hazard ratio [HR] = 2.18;95% confidence interval [CI] 1.29, 3.67; P = 0.004) and patulous ET reconstruction (HR = 1.62; 95% CI 1.04, 2.52; P = 0.035).Patients undergoing shim insertion (52.2%) and obliteration (81.8%) were likely to require pressure equalization tubes or tohave had otitis media with effusion.

Conclusion: Although all procedures potentially resulted in symptom resolution, placement of a shim or obliteration ofthe ET lumen was more likely to achieve 12-month resolution of PETD symptoms and more likely to result in otitis media witheffusion than hydroxyapatite injection or patulous ET reconstruction.

Key Words: Patulous Eustachian tube, autophony, Eustachian tube.Level of Evidence: Level 4

Laryngoscope, 129:222–228, 2019

INTRODUCTIONPatulous Eustachian tube dysfunction (PETD) is

thought to result from a longitudinal concave defect in

the mucosal functional valve, usually in the anterolateral

wall of the Eustachian tube (ET). The anterolateral wall

of the functional valve normally has a convex bulge into

the lumen that is comprised of mucosa, submucosa, the

lateral cartilaginous lamina, Ostmann’s fat, and the ten-

sor veli palatini muscle (TVP). Patients report the percep-

tion of their own voices and nasal breathing sounds as

being abnormally loud (autophony) or distorted, and they

may additionally experience aural fullness or pulsatile

tinnitus.1–7 Although these symptoms can be persistent,

they are often intermittent, triggered by activities such

as exercise or prolonged talking,8 and relieved by an

upper respiratory tract infection causing nasal congestion

or when in a recumbent position.

To diagnose PETD, clinicians should observe medial

and lateral excursions of the tympanic membrane coinci-

dent with ipsilateral nasal breathing at a time when the

patient’s autophony is active. This can be seen best with

the patient seated upright because lying supine may

cause venous congestion around the ET, closing the valve.

Movements of the tympanic membrane will not be

observed when the patient is asymptomatic.

There is no standard treatment for PETD. Manage-

ment begins with discontinuing agents that can exacer-

bate symptoms, such as caffeine, decongestants, topical

nasal steroids, and diuretics if medically appropriate.8,9

Increased hydration and nasal saline drops or irrigations

can be helpful. Mucus-thickening agents, topical estrogen

drops, and topical irritants can induce mucosal edema or

thickening and are effective, but they usually provide

From the Department of Otolaryngology–Head and Neck Surgery,Johns Hopkins School of Medicine (B.K.W., G.A.), Baltimore, Maryland;Department of Otolaryngology and Communication Enhancement, BostonChildren’s Hospital and Harvard Medical School (K.K., Y.A., T.R., D.S.P.),Boston, Massachusetts, U.S.A; Department of Otolaryngology, ChangGung Memorial Hospital, Keelong, Chang Gung University (W-C.C.),Taoyuan, Taiwan

Editor’s Note: This Manuscript was accepted for publication onJune 20, 2018.

Bryan K Ward, MD and Wei-Chieh Chao, MD contributed equallyto this work.

Presented at the Triological Society Combined OtolaryngologySpring Meetings (COSM), National Harbor, Maryland, U.S.A., April20, 2018.

Dennis Poe is a paid consultant for Acclarent, Inc., but has noequity interest; he completed a trial for Eustachian tube dilation balloonsand has financial interest in nasal spray for otitis media (not yet in phaseI trials). The authors have no other funding, financial relationships, orconflicts of interest to disclose.

Send correspondence to Bryan K. Ward, MD, Johns Hopkins Outpa-tient Center, 6th floor, Department of Otolaryngology–Head and NeckSurgery, 601 North Caroline Street, Baltimore, MD 21287.E-mail: bward15@jhmi.edu

DOI: 10.1002/lary.27443

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The Laryngoscope© 2018 The American Laryngological,Rhinological and Otological Society, Inc.

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temporary relief. Although weight gain has been sug-

gested as a remedy, it is rarely effective and not recom-

mended unless the patient is medically underweight.7

Surgical management of PETD can include addres-

sing the middle ear by placing a tympanostomy tube,

mass loading of the tympanic membrane,10,11 or placing a

transtympanic plug.12–16 Other approaches address the

nasopharyngeal end of the ET and include inserting an

angiocatheter surrounded by bone wax for occlusion of

the ET lumen,8,9,17 augmentation with calcium hydroxy-

apatite cement,18,19 surgically reconstructing the ET

valve,8,20–24 or permanently obliterating the ET lumen.20

Two recent systematic reviews showed a wide range of

outcomes with heterogeneous study design, limiting the

ability to compare groups.25,26 There is little data on

long-term outcomes of the above nasopharyngeal proce-

dures, and there have been no studies at a single institu-

tion comparing outcomes among them. This study aims to

examine the 12-month effectiveness of these procedures.

MATERIALS AND METHODSAll outpatient clinic visits to the senior author (2004–2016,

D.S.P.) were queried for the assigned International Classification

of Diseases, 9th revision diagnosis code 381.7 Patulous Eusta-

chian tube. Each patient’s medical record was then reviewed

(n = 340). Those patients undergoing surgery for PETD (n = 96,

28.2%) were retrospectively reviewed for demographics, risk fac-

tors, physical examination findings, and the duration of symptom

resolution after surgery. The diagnosis of PETD was made based

on the presence of symptoms consistent with PETD (breath

autophony, aural fullness, and voice distortion), the exclusion of

disorders with overlapping symptoms, and evidence of synchro-

nous movement of the tympanic membrane in response to ipsilat-

eral nasal breathing on otoscopy or acoustic reflex decay mode

testing. Prior to undergoing surgery, all patients underwent a

trial of medical management for at least 6 months, including

increased hydration, topical nasal therapies such as saline or

ascorbic acid drops, and removing decongestants and caffeine.

Four classes of transnasal–transoral endoscopic procedures

were performed to repair PETD. Surgical procedures included 1)

insertion of an intravenous catheter (shim) into the full length of

the ET lumen (off-label use), 2) injection of calcium hydroxyapa-

tite cement (ProLaryn Plus, BioForm Medical, San Mateo, CA;

off-label use) into the submucosa of the ET to provide bulk, 3)

patulous ET reconstruction (PETR) by a variety of methods to

decrease the lumen diameter, or 4) permanent obliteration of the

ET lumen. All procedures were performed as outpatient surgery

under general anesthesia, and transnasal endoscopic assistance

was used to view the lumen of the ET from its nasopharyngeal

orifice. All of the procedures were performed with a 45-degree

nasal endoscope (Karl Storz, Culver City, CA) in the ipsilateral

nasal cavity for viewing, and instruments passed transorally.

Selection of the procedure was determined based on the size and

location of the concave defect within the valve or whether previ-

ous procedures had been performed. A minimally invasive proce-

dure was generally selected as an initial procedure, either by

insertion of a shim or injection with calcium hydroxyapatite. The

most common defects were located in the valve at or adjacent to

the 12:00 position within the lumen, where the mucosa is thin

and tightly bound to the cartilage. Injection would be unfavor-

able in that location because the submucosa would not hold much

of the filler material. Therefore, insertion of a shim was most

commonly used. Small defects that were favorably located near

the center of the lumen’s cross-sectional area may be selected for

injection. PETR was usually performed for failure of the above

two procedures, and obliteration was used for failure of PETR.

Some patients underwent surgery on bilateral ETs, and

some underwent multiple procedures if they had inadequate

symptom control from a prior patulous ET surgery. No patient

underwent obliteration of the ET lumen as a first procedure.

Techniques were classified as shim placement if a foreign

material was inserted into the ET lumen from the nasopharynx

and the material could later be removed, without permanently

altering the ET anatomy. An intravenous angiocatheter (14–18

gauge) was filled with bone wax by aspirating molten wax into

the lumen, allowing it to harden, then trimming the Luer lock

side to a length usually 38 to 40 mm for females and 40 to

42 mm for males. It was loaded into an insertion tool (Karl Storz,

Culver City, CA), passed transorally up to the orifice of the ET,

and then inserted into the full length of the lumen. Mild resis-

tance was noted as it passed through the isthmus, which would

hold the shim in position over time. The shim, being flexible,

would lay into the longitudinal concave defect in an attempt to

restore competency for closure of the functional valve.

A procedure was classified as calcium hydroxyapatite injec-

tion if a permanent filler material was injected deep to the muco-

sal surface of the cartilaginous portion of the ET in order to

increase the bulk within the functional valve. Injection of calcium

hydroxyapatite cement was performed by guiding a needle

transorally or transnasally and injecting submucosally around

the lumen of the ET and longitudinally along the length of the

cartilaginous portion. The senior investigator (D.S.P.) used visual

feedback to determine the amount of calcium hydroxyapatite

injected. Tympanostomy tubes were not routinely placed during

procedures for shim placement or calcium hydroxyapatite

injection.

Procedures were classified as PETR if they involved tech-

niques to narrow the lumen of the ET in order to restore its com-

petency as a valve and without intending to completely occlude

the lumen. The reconstruction techniques varied over time, but

all had the intended goal of narrowing the ET valve by extralum-

inal compression. Techniques included transposition of the

medial cartilaginous lamina or establishing a submucosal pocket

with insertion of different materials such as fat, cartilage, acellu-

lar dermal matrix (Alloderm, LifeCell Corp., Branchburg, NJ),

and silicone to decrease the lumen diameter of the ET (tech-

niques previously reported8). Obliteration of the ET lumen is per-

formed as in PETR, except the mucosa is circumferentially

denuded with the intent of inducing atresia of the

ET. Tympanostomy tube placement or myringotomy was rou-

tinely performed at the time of PETR or obliteration of the

ET. Figure 1 shows sample surgical images of the four procedure

classes.

All patients undergoing surgery during the study period

were included in the analysis if they had follow-up of at least

12 months after surgery; each ET was counted as a separate pro-

cedure. Patient demographics and clinical characteristics were

compared by procedure type using chi-square test for categorical

variables and Kruskal-Wallis and Wilcoxon rank sum tests for

continuous variables. Kaplan-Meier survival curves were con-

structed for each procedure to compare the risk of failure during

the first year, for which failure was defined as the patient-

reported recurrence of any symptoms of PETD in the affected ear.

This was recorded by reviewing the records for any contact with

the patient about symptoms after surgery, and in some cases con-

tacting the patient via telephone. The frailty model, which is an

extension of the Cox proportional hazards model that incorporates

cluster-specific random effects, was employed to account for the

correlation between ears and correlation from repeated surgeries

within an individual. The lognormal distribution was specified for

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223

75

the frailty term. Hazard ratio (HR) and 95% confidence interval

(CI) were estimated. Model diagnostics were performed to evalu-

ate the fit of the model and confirm the proportional hazards

assumption. All analyses were conducted using SAS version 9.4

(SAS Institute Inc., Cary, NC) and R statistical software. This ret-

rospective study was approved by the Boston Children’s Hospital

internal review board, Boston, Massachusetts.

RESULTSDuring the study period, 276 ET procedures were

performed on 96 patients. We excluded 16 patients who

underwent 35 procedures due to the lack of evidence in

the records of definite pressure transmission to the mid-

dle ears (n = 11 patients) or due to the lack of 12-month

follow-up (n = 5 patients, n = 6 procedures). One patient

who underwent bilateral PETR was lost to follow-up, as

well as one patient each who underwent unilateral oblit-

eration, PETR, calcium hydroxyapatite injection, and

shim insertion. We included 241 procedures (176 outpa-

tient surgeries) performed on 80 patients. Patients under-

went a mean of 3.0 ET procedures (range 1–17) or 2.2

outpatient surgeries (range 1–10). Demographics for

included patients are shown in Table I.

Of the procedures included for analysis, the most

common was shim insertion (n = 115, 47.8%), followed by

PETR (n = 77, 31.9%), calcium hydroxyapatite injection

(n = 38, 15.7%), and ET obliteration (n = 11, 4.6%). Data

for the included procedures is shown in Table II.

For all procedures, the median duration of complete

symptom relief was 5.0 months (interquartile range

[IQR]: 1.1–15.5 months) (Table III), and the risk of symp-

tom reappearance within 12 months was 50.6% (122 of

241 procedures). The median duration of symptom relief

varied by procedure class, which ranged from 3.0 months

(IQR: 0.7–7.0 months) for calcium hydroxyapatite injec-

tion to 20.6 months (3.4–35.9 months) for ET obliteration.

All 11 patients who underwent ET obliteration had reso-

lution of PETD symptoms at 12 months. The second low-

est frequency of disease recurrence within 12 months

occurred with shim insertion at 24.6%. Compared to shim

placement, risk of 12-month failure was significantly

higher for calcium hydroxyapatite injection (hazard ratio

[HR] = 2.18; 95% confidence interval [CI] 1.29, 3.67;

Fig. 1. Examples of each of class of surgical approaches used in this series to repair a patulous ET, all right side. The upper panel shows shiminsertion into the lumen of an ET before, during, and after insertion. The second panel shows an injection of calcium hydroxyapatite submuco-sally to decrease the size of the ET lumen. The third shows a patulous ET reconstruction, in which the mucosa of an ET was denuded exceptfor a strip along the inferior border, and the ET was sutured closed. The final series shows a total obliteration of the ET, in which mucosa wascircumferentially denuded and the lumen was sutured closed, resulting in atresia of the ET. ET = Eustachian tube.

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P = 0.004) and PETR (HR = 1.62; 95% CI 1.04, 2.52;

P = 0.035) (Table IV) (Fig. 2). Patients undergoing a pro-

cedure for the first time (n = 109) had a higher risk of

failure in the first 12 months after calcium hydroxyapa-

tite injection (HR = 4.92; 95% CI 2.30, 10.51; P < 0.001)

and PETR (HR = 2.09; 95% CI 1.00, 4.34; P = 0.04) than

after shim insertion (Figure 3). For patients who were

excluded but for whom we had adequate follow-up data,

the rates of symptom resolution at 12 months were simi-

lar to that of all included procedures.

Among patients undergoing PETR, the use of fat as

a filler material was associated with a higher rate of

failure (HR = 2.37; 95% CI 1.09, 5.16; P = 0.03). Among

patients undergoing calcium hydroxyapatite injection, a

greater amount of material injected was associated with

lower likelihood of symptom resolution (HR = 2.15; 95%

CI 1.14, 4.07; P = 0.018) (Table IV). Surgical experience

did not impact outcomes because there were no differ-

ences in likelihood of symptom resolution at 12 months

for any procedure in the first 6 years (2004–2010) com-

pared to the second 6 years (2011–2016; P > 0.05).

ComplicationsThe procedures were well tolerated with a surgical

complication rate of 3.4% (n = 6 out of 176 outpatient sur-

geries). Uvula edema occurred in three patients undergo-

ing PETR and one undergoing bilateral shim placement.

Tongue edema with temporary change in taste occurred

in one patient undergoing PETR. One patient developed

an infratemporal fossa hematoma resulting in lingual

nerve hypesthesia (ipsilateral numbness of tongue, gin-

giva, and lower lip; altered taste) after calcium hydroxy-

apatite injection that improved over months. There were

no carotid artery injuries.

At surgery, 17% (n = 20) of ears undergoing a shim

insertion, 21% (n = 8) undergoing hydroxyapatite injec-

tion, 78% undergoing PETR (n = 60), and 100% (n = 11)

undergoing obliteration had a tympanostomy tube in

place or received a new one. Patients undergoing shim

TABLE I.

Demographics, All Patients (n = 80 patients)

Mean (SD)

Age, years 38.4 (17.6)(range: 11 – 84)

Symptomduration, years

6.8 (8.3)

n (%)

Gender Male 37 (46%)

Female 43 (54%)

Affected side Right 22 (28%)

Left 12 (15%)

Bilateral 46 (58%)

Symptoms Voice distortion 78 (98%)

Breath autophony 76 (95%)

Aural fullness 46 (58%)

Pulsatile tinnitus 21 (27%)

Crackling/rumbling sound 16 (20%)

Comorbidities Environmental allergies 30 (38%)

Weight loss at symptom onset 29 (36%)

Gastroesophageal reflux disease 27 (34%)

Reported stress and anxiety 22 (28%)

Oral contraceptive use 12 (15%)

Rheumatologic conditions 13 (16%)

Temporomandibular disorder 8 (10%)

Currently smoking 7 (9%)

Hormone replacement therapy use 3 (4%)

Pregnant at start of symptoms 3 (4%)

Neuromuscular disease 2 (3%)

None 11 (14%)

Prior treatments

Medical therapy Ascorbic acid (PatulEnd) 40 (50%)

Conjugated estrogens (Premarin) 37 (46%)

Saturated solution ofpotassium iodide

19 (24%)

Hypertonic saline 16 (20%)

Procedural therapy Tympanostomy tube 26 (33%)

Injection of filler 12 (15%)

Patulous Eustachiantube reconstruction

8 (10%)

Shim insertion 3 (4%)

Botox injection 1 (1%)

PatulEnd (The Ear Foundation, Santa Clara, CA), Premarin (Pfizer, NewYork, NY).

SD = standard deviation.

TABLE II.

Included Procedures (n = 241 procedures)

Shim insertion 115 (48%)

Shim length (mm), mean (SD) 38 (2.1)(range: 30–42)

Shim width (gauge), mean (SD) 14.5 (1.0)(range: 14–18)

Hydroxyapatite injection, n (%) 38 (16%)

Amount injected (mL), mean (SD) 1.2 (0.6)(range: 0.2–2.5)

Patulous Eustachian tubereconstruction

77 (32%)

Submucosal pocket, n (%) 36 (46%)

Cartilage transposition, n (%) 18 (23%)

Simultaneous hydroxyapatiteinjection, n (%)

10 (13%)

Reconstruction material

Alloderm, n (%) 22 (25%)

Cartilage, n (%) 28 (36%)

Fat, n (%) 24 (31%)

Fascia, n (%) 2 (3%)

Silicone, n (%) 2 (3%)

None, n (%) 2 (3%)

Obliteration 11 (5%)

Obliteration material

Alloderm, n (%) 4 (36%)

Fat, n (%) 4 (36%)

Fascia, n (%) 3 (27%)

Alloderm, LifeCell Corp, Branchburg, NJ.SD = standard deviation.

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insertion (52.2%) or obliteration (81.8%) were more likely

to require subsequent tympanostomy tubes or to develop

otitis media with effusion than those who received

hydroxyapatite injection (10.5%) or PETR (10.4%). Of those

undergoing shim placement (n = 115), 14 (12%) shims

became dislodged: six had partial displacement presenting

either as pain (n = 2) or return of symptoms (n = 4); and

eight had complete displacement, being expelled either via

spitting up (n = 2), sneezing, or blowing out the nose

(n = 4). In two cases, the patient was assumed to have

swallowed the catheter because they developed symptoms

but were unaware that the catheter was missing. There

were no instances of aspiration of a shim. In four cases,

bone wax from the shim partially extruded into the middle

ear and was removed via myringotomy.

DISCUSSIONHalf of patients experienced resolution of their PETD

symptoms lasting over 1 year, similar to rates of symptom

resolution reported in two recent meta-analysis.25,26 There

were differences, however, among the procedures in the

duration of symptom resolution. Placement of a shim had

lower rates of failure at 12 months compared to injection

of calcium hydroxyapatite cement and to procedures

intending to reconstruct the ET lumen. Approximately

three-quarters of patients undergoing a shim placement as

their first procedure on the ET experienced resolution of

TABLE III.

Surgical Treatment of Patulous Eustachian Tube (241 procedures from 80 patients)

Overall (n = 241)

By Procedure Class

Shim (n = 115) HA Injection (n = 38) PETR (n = 77) Obliteration (n = 11) P Value

Duration of symptom relief, months 0.011

Mean (SD) 13.2 ( ± 21.1) 14.4 ( ± 21.2) 7.7 ( ± 14.6) 12.1 ( ± 21.2) 28.0 ( ± 32.1)

Median (IQR) 5.0 (1.1–15.5) 6.0 (1.9–18.0) 3.0 (0.7–7.0) 4.6 (0.7–15.0) 20.6 (3.4–35.9)

Symptom recurrence within 1 year 122 (50.6%) 45 (39.1%) 26 (68.4%) 51 (66.2%) 0 (0%) < 0.001

Required PET/OME 81 (33.6%) 60 (52.2%) 4 (10.5%) 8 (10.4%) 9 (81.8%) < 0.001

HA = hydroxyapatite; IQR = interquartile range; OME = otitis media with effusion; PET = pressure equalization tube; PETR = patulous Eustachian tubereconstruction; SD = standard deviation.

TABLE IV.

Risk of Symptom Reappearance Within 1 Year After SurgicalTreatment of Patulous Eustachian Tube Dysfunction

% HR (95% CI) P Value

Based on first procedure(n = 109)

Shim insertion 24.6% Reference

Hydroxyapatite injection 63.2% 4.92 (2.30, 10.53) < 0.001

Patulous ET reconstruction 52.0% 2.09 (1.00, 4.34) 0.04

All procedures (n = 241)

Shim insertion 39.1% Reference

Hydroxyapatite injection 68.4% 2.18 (1.29, 3.67) 0.004

Patulous ET reconstruction 66.2% 1.62 (1.04, 2.52) 0.035

Obliteration 0% –

Prior PETR procedure

Yes 62.5% 1.45 (0.98, 2.14) 0.05

No 42.8% Reference

Details of each procedure

Shim placement

Length (range: 30–42 mm) – 0.98 (0.83, 1.16) 0.81

Width (range: 14–18 gauge) – 0.90 (0.65, 1.26) 0.54

Hydroxyapatite injection

Volume injected(range: 0.2–2.5 mL)

– 2.15 (1.14, 4.07) 0.018

Patulous Eustachian tubereconstruction

Presence of cartilagetransposition

55.6% 0.94 (0.47, 1.89) 0.87

Submucosal pocket 61.1% 0.74 (0.42, 1.29) 0.29

Accompanying hydroxyapatiteinjection

80.0% 1.32 (0.62, 2.83) 0.47

Type of materials

Alloderm 55.6% Reference

Cartilage 60.7% 1.17 (0.54, 2.56) 0.70

Fat 81.8% 2.37 (1.09, 5.16) 0.03

Others 66.7% 1.64 (0.59, 4.53) 0.34

Alloderm, LifeCell Corp, Branchburg, NJ.CI = confidence interval; ET = Eustachian tube; HR, hazard ratio;

PETR = patulous Eustachian tube reconstruction.

Fig. 2. Surgical management of patulous Eustachian tube for allprocedure classes (241 procedures; log-rank test P < 0.001). HR =hazard ratio; PETR = patulous Eustachian tube reconstruction.[Color figure can be viewed in the online issue, which is available atwww.laryngoscope.com.]

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symptoms 12 months later. Although the shim can remain

in place for years, it became dislodged in 12% of patients.

In the majority of these cases, this was expelled via a

cough or sneeze. There were no cases of aspiration. Roten-

berg et al. has reported success in suturing the shim to

nasopharyngeal mucosa in a smaller series.17 Others have

reported similar success using a transtympanic approach

to the bony ET via an anterior tympanotomy or myringot-

omy to either occlude its lumen with an angiocatheter13,16

or to place a shim.12,15 In general, the surgeries were well

tolerated, with no carotid artery injuries and a low rate of

perioperative complications, mostly related to palate

retraction during longer procedures such as PETR.

Although placement of a tympanostomy tube has

been reported to reduce symptoms in up to 54% of

patients with PETD,10 it may also exacerbate them.27 In

patients in whom tympanostomy tubes are effective, they

may work by mass loading the tympanic membrane or by

providing a route for pressure equalization, thereby mini-

mizing excursions of the tympanic membrane.28 In this

series, 33% of patients underwent tympanostomy tube

placement prior to pursuing additional treatment, and

20% (n = 5) reported that the tube made their symptoms

worse. Some patients undergoing ET surgery also had a

tympanostomy tube placed during the procedure in order

to address temporary ET dilatory dysfunction caused by

the procedure. Concomitant placement of tympanostomy

tube was uncommon among those undergoing shim inser-

tion or calcium hydroxyapatite injection but common

among those undergoing PETR and obliteration. For

PETR, it was thought that these procedures might more

likely result in temporary effusion because the lumen was

functionally occluded by the combination of surgical

reduction of the lumen and intraoperative swelling of the

tissues. Despite having the lowest rate of simultaneous

tympanostomy tube placement, insertion of a shim had

the highest rate of symptom resolution, indicating the

tympanostomy tube did not meaningfully confound the

results. Nevertheless, patients undergoing shim

placement were likely to require subsequent tympanost-

omy tube placement, suggesting a relationship between

the effectiveness of the procedure for reducing PETD

symptoms and the likelihood of interfering with the nor-

mal dilatory function of the ET.

Total obliteration of the ET lumen successfully

resolves PETD symptoms; however, this results in

chronic middle ear effusions that also produce symptoms

of aural fullness and autophony. The chronic effusions

are often thick and mucoid and frequently occlude tympa-

nostomy tubes.29 Although anecdotally patients are con-

tent to be relieved of their PETD, these chronic mucoid

effusions are difficult to manage. Total ET obliteration

should be carefully considered only as a last resort.

The injection of hydroxyapatite cement and PETR

tended to perform worse than shim placement or total

obliteration. Injecting a larger volume of filler was also

associated with a lower likelihood of enduring symptom

relief. This may be the result of calcium hydroxyapatite

being less successful in larger defects, with the injected

filler tending to diffuse away from the lumen. Although

there is currently no measure of the size of the defect,

variations in the size of the defect in the anterolateral

wall has been observed by the senior author (D.S.P).

Among the four classes of transnasal, transoral

endoscopic ET procedures in this study, PETR had the

greatest variability in technique. The procedures had a

common goal of restoring the normal convexity of the

anterolateral wall of the ET; nevertheless, the group was

heterogeneous. We attempted to account for this by

adjusting for different techniques as variables in our

analysis. The use of Alloderm (LifeCell Corp.) was associ-

ated with a lower chance of failure, and the use of autolo-

gous fat was associated with a higher chance of failure.

This may be due to qualities of the material and the like-

lihood of its becoming dislodged or absorbed. In several

cases in which autologous fat was used as the filler in the

reconstruction, patients reported the fat becoming dis-

lodged. Ongoing work is being done to improve the tech-

niques for PETR in the goal of yielding better long-term

results.

Although this study compares outcomes among

transnasopharyngeal approaches for PETD, it is not

exhaustive. Other nasopharyngeal techniques include

procedures affecting the TVP muscle or tendon.30,31

Whereas in this study calcium hydroxyapatite was used

as a semipermanent filler, others have used materials

such as fat or cartilage,20,24 absorbable gelatin,32 polydi-

methylsiloxane elastomer,27,33 and Teflon paste.34 Polydi-

methylsiloxane elastomer (Vox, Endotherapeutics,

Epping NSW, Austrailia) is currently unavailable in the

United States, and Teflon has been abandoned due to

instances of cerebral embolism and death, possibly from

injection of Teflon into the internal carotid artery.

Improved endoscope technology, knowledge of the loca-

tion of the defect in the valve within the lumen of the ET,

and attention to the surgical anatomy of the relationship

between the ET and the internal carotid artery have

likely improved the accuracy and safety of injections.

Finally, techniques have also been developed to mass load

the tympanic membrane, with the majority of patients

Fig. 3. Surgical management of patulous ET for first procedure per-formed on the ET. ET = Eustachian tube; HR = hazard ratio;PETR = patulous Eustachian tube reconstruction. [Color figure canbe viewed in the online issue, which is available at www.laryngoscope.com.]

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reporting improvements in symptoms28 with minimal

changes in hearing.35

As a retrospective study, there are inherent limita-

tions related to the charting of data and bias introduced

by the time at which patients call with return of symp-

toms. We chose a binary outcome variable of any symp-

toms returning, which therefore counts as failures those

patients whose symptoms improved to a tolerable level.

There are few outcome measures for PETD. A candidate

symptom-based instrument (Eustachian Tube Dysfunc-

tion Questionnaire-7)36 has not been found to discrimi-

nate dilatory from patulous ET dysfunction.37,38 A

previously proposed outcomes measure by the senior

author (D.S.P)8 needs to be prospectively validated and

was unavailable for the majority of patients in this study.

A standardized outcome measure would help compare

more discrete differences in outcomes among the

procedures.39

Approximately one-quarter of all patients evaluated

by the senior author (D.S.P.) and diagnosed with PETD

during the study period were refractory to medical man-

agement and underwent surgery. Many patients choosing

surgery undergo multiple procedures, indicating that

none of the procedures result in a perfect outcome. We

believe most patients with PETD can be treated medi-

cally with a reasonable rate of successful symptom

control.

CONCLUSIONTransnasal, transoral procedures for patulous ET

dysfunction are well tolerated. Patients can experience

symptom resolution, regardless of the technique. Shim

insertion and obliteration have more enduring symptom

resolution yet high prevalence of otitis media with effu-

sion or the need for tympanostomy tubes.

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