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Original Study

Transtympanic Tripod-shaped Angiocatheter Insertion for Patients


With Intractable Patulous Eustachian Tube
yJung Mee Park, yJae Sang Han, zSo Young Park, and yShi Nae Park
Department of Otorhinolaryngology-Head and Neck Surgery, Gangneung Asan Hospital, College of Medicine University of Ulsan,
Gangneung; yDepartment of Otolaryngology-Head and Neck Surgery, Seoul St. Mary’s Hospital; and zDepartment of
Otolaryngology-Head and Neck Surgery, Yeouido St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul,
Republic of Korea
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Objective: Despite the efforts to treat patients with patulous (59.4% vs. 40.6%). Both ears were operated in six patients,
Eustachian tube (PET), intractable symptoms of PET may simultaneously in three. All patients successfully received
require surgical intervention. In this study, we introduce our the insertion of TTA, with no immediate complication.
surgical technique of ‘‘transtympanic tripod-shaped angio- Eleven cases were re-inserted after the first insertion due to
catheter’’ (TTA) insertion and evaluate the safety and the recurrence of symptoms or spontaneous extrusion of
efficacy of the procedure in patients with intractable PET. TTA. No major complications were observed during the
Study design: Retrospective chart review. follow-up period of 1 to 115 months (mean 37.7 mo). The
Setting: Tertiary referral center. average Visual Analogue Scale score of PET symptoms was
Patients: Thirty-two cases (26 patients) diagnosed with significantly decreased ( p < 0.05), along with 92% of
intractable PET between the years 2011 and 2019 were patients with relief from autophony symptoms.
included in this study. Conclusions: TTA insertion is a relatively simple procedure
Intervention: All cases were surgically treated with TTA that can be performed in a short period under local
insertion. anesthesia. Surgical intervention of TTA insertion for
Main outcome measures: The clinical characteristics, surgi- patients with intractable PET symptoms seems promising
cal results, complication rates, and the level of satisfaction with a high success rate. Key Words: Intervention—
by questionnaires were analyzed for evaluation. Patulous eustachian tube—Transtympanic.
Results: The mean age of enrolled patients was
40.9  19.5 years, with slight male gender predominance Otol Neurotol 42:e1273–e1278, 2021.

INTRODUCTION the superior aspect of the anterolateral wall due to loss or


atrophy of adipose tissue surrounding ET (2). Such
The Eustachian tube (ET) is an anatomic osseocarti- conditions may be related to environmental allergy,
laginous structure surrounded by muscles and fat, weight loss, laryngopharyngeal reflux, neurological dis-
ascribed by Antonio Valsalva in 1704 (1). One of the order, pregnancy, and hormone replacement therapy (3).
main functions of the ET is the regulation of pressure in Patients with PET experience troublesome symptoms
the middle ear cavity via dynamic tubal opening and such as autophony, ear fullness, humming tinnitus, and
closing. The patulous Eustachian tube (PET) is defined as hearing one’s breathing sounds known as tympanophonia
abnormal patency of the tube and is thought to be caused that is synchronous with respiration (2,3). The continuous
by a longitudinal concave defect in the mucosal valve at symptoms of PET may lead to anxiety, depression, and
social isolation. Conservative treatments that include
lifestyle changes, as well as some medications, were
Address correspondence and reprint requests to Shi Nae Park, M.D., reported to be somewhat effective in controlling the
Ph.D., Department of Otolaryngology-Head and Neck Surgery, Seoul symptoms, and various surgical procedures that manipu-
St. Mary’s Hospital, College of Medicine, The Catholic University of late the tympanic membrane or occludes the lumen of the
Korea, 222 Banpo-daero, Seocho-gu, Seoul, 06591, Republic of Korea;
E-mail: snparkmd@catholic.ac.kr ET by several materials have been introduced in the
The design of this retrospective study was reviewed and approved by literature for severe cases (4,5). Despite the efforts, there
the institutional review board of the associated institution (IRB No. is no consensus on the management of intractable PET
KC16RISI0544 of Seoul St. Mary’s Hospital, the Catholic University of since published literature depends on small case series
Korea).
The authors disclose no conflicts of interest.
studies with various intervention techniques (5).
Supplemental digital content is available in the text. In this study, we introduce ‘‘transtympanic tripod-
DOI: 10.1097/MAO.0000000000003254 shaped angiocatheter’’ (TTA) insertion for intractable

ß 2021, Otology & Neurotology, Inc.

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e1274 J. M. PARK ET AL.

PET patients in a long-term follow-up study by analyzing final surgery. Clinical characteristics of the enrolled patients
its safety and efficacy, as well as complications following and clinical courses after TTA insertion were evaluated retro-
this procedure. spectively.

MATERIALS AND METHODS Design of TTA and Surgical Technique


Angiocatheters of 16, 18, and 20 gauges were aseptically
Enrolled Subjects and Assessments prepared previous to surgery. The inner space of each angio-
A total of 32 PET cases from 26 patients who received TTA catheter was filled with liquified bone wax through a syringe.
insertion between the years 2011 and 2019 at a tertiary hospital After bone wax was solidified, the catheter was tapered accord-
were enrolled for a retrospective analysis after obtaining ing to the approximated length of the patient’s ET determined
approval from the institutional review board. The CARE Case by the preoperative CT. To prevent spontaneous extrusion of
Report Guidelines (https://www.equator-network.org/repor- angiocatheter into the nasopharynx, the tapered, lateral end of
tingguidelines/care/) were followed for this study. the catheter was cut into a tripod shape to work as an anchor.
Patients were diagnosed with definite PET if they satisfied Therefore, the final length of the catheter was the distance from
all of the following inclusion criteria: 1) observation of syn- the isthmus to the bony orifice of the ET, with 2.5 mm added for
chronous to and fro movement of the tympanic membrane the tripod shape (Fig. 2). This specially designed catheter was
during ipsilateral forced nasal breathing under oto-endoscopic named ‘‘TTA,’’ as described in our previous case report in the
examination (Appendix 1 [the to and fro movement of the year 2014 (7). The surgery was performed under local anesthe-
tympanic membrane during forced nasal breathing of PET sia. After making a small linear incision on an anterosuperior
patient demonstrated under oto-endoscopic examination], portion of the tympanic membrane, the inner diameter of the ET
http://links.lww.com/MAO/B292); 2) perturbation of imped- was approximated by inserting three different sizes of blunt-
ance tympanogram during breathing (Fig. 1A); 3) ringing of ended lacrimal probes into the tympanic orifice of ET that
‘‘m’’ and ‘‘n’’ vocal sounds auscultated through the Toynbee matched 16, 18, and 20 gauge angiocatheters. The most tightly
tube by the examiner. Preoperative CT scans and audiometry fitting gauge was chosen for the patient. The selected gauge
were also performed to evaluate any abnormalities in the middle TTA was then slightly bent for the natural curvature of ET and
ear and the Eustachian tube, as well as for the superior semi- was slowly inserted into the tympanic orifice. Finally, the
circular canal dehiscence which can present with similar symp- myringotomy site was covered using a paper patch.
toms (Fig. 1B). All enrolled patients were definite and
‘‘intractable’’ PET patients, who were nonresponders to con-
Ethical Considerations
servative treatments that included behavior therapy such as
All enrolled patients were fully informed of the surgical
drinking sufficient water and inducing weight gain, use of
techniques and provided written informed consent at the time of
anticholinergic nasal spray, and minor surgical intervention
surgery. The design of this retrospective study was reviewed
that included paper patching or myringotomy with/without
and approved by the institutional review board of the associated
ventilation tube insertion for at least 3 months. Outcomes of
institution.
TTA insertion were assessed by Poe’s autophony scoring
system (Appendix 2, http://links.lww.com/MAO/B326) (2)
and 5-item questionnaires with Visual Analogue Scale Data Availability Statement
(VAS) (Appendix 3, http://links.lww.com/MAO/B326) modi- An anonymized data that support the findings of this study
fied from the Cambridge ETD Assessment (6) 2 weeks after the are available from the corresponding author upon request.

FIG. 1. (A) Impedance tympanogram assessed during respiration in a PET patient. Severe sawtooth-like perturbations are shown. (B)
Preoperative temporal bone CT scan showing a relatively wide bony portion of the Eustachian tube. (Red box) Anatomical variations of air
cells adjacent to the Eustachian tube may interfere with the smooth insertion of TTA and should be checked preoperatively. PET, patulous
Eustachian tube. TTA, transtympanic tripod-shaped angiocatheter.

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TRANSTYMPANIC ANGIOCATHETER INSERTION FOR PATULOUS EUSTACHIAN TUBE e1275

The size of the inserted angiocatheter ranged from 16 to


20 gauges. Out of 32 cases, 20 cases were inserted with
16 gauge angiocatheter, 10 cases were inserted with 18
gauge angiocatheter, and two cases were inserted with 20
gauge angiocatheter at the time of their final surgery. The
length of angiocatheter determined by the preoperative
CT varied from 20 to 28 mm. There was no statistically
significant correlation between the size of the selected
TTA and the diameter of the bony ET estimated from the
temporal bone CT ( p ¼ 0.542). The size of TTA did not
correlate with the gender of the patients either
( p ¼ 0.467). However, male patients were tended to be
inserted with the thicker TTA, as 68.4% of male patients
were inserted with the thickest, 16-gauge, angiocatheter
compared to 58.3% in females. The size and length of the
FIG. 2. (A) A schematic illustration of inserted TTA in a Eustachian TTA did not affect the patient’s final satisfaction score
tube. (B) A picture of an actual 18-gauge angiocatheter filled with ( p ¼ 0.119 and p ¼ 0.152, respectively).
bone wax. The tip is cut into a shape of a tripod for firm anchoring.
(C) An inserted TTA in a Eustachian tube is demonstrated in the The symptoms of PET were resolved entirely with a
axial view of the temporal bone CT scan postoperatively (white single insertion of TTA in 21 cases out of 32 operated
arrows). TTA, transtympanic tripod-shaped angiocatheter. cases (66%), whereas 11 cases were re-operated due to
recurrence of symptoms (nine cases) and spontaneous
RESULTS extrusion of TTA into the nasopharynx (two cases). The
recurrent PET symptoms of the re-operated patients
The mean age of 26 enrolled patients was 43.2 years occurred as short as within 3 days, up to 18 months
(range, 20–75 yrs). The age distribution showed that postoperatively. Although the majority of enrolled
53.8% of the patients were in their 20s to 30s, with the patients were inserted with TTA once or two times
remaining patients (46.2%) in their 50s or older (Fig. 3). (90.6%), three cases were re-inserted with TTA up to
The male to female ratio was 17 to 9 (59.4% vs. 40.6%), four times with a larger size angiocatheter than previous
and the right to left ear ratio was 12 to 20. Six patients were surgery. The replacement was proceeded with the same
operated bilaterally, simultaneously in three patients. All surgical technique as the first insertion, as the previously
patients complained of aural fullness and autophony, as inserted TTA could be easily removed with microforceps
92.3% of the patients experienced tympanophonia, fol- through the myringotomy site. One patient who continu-
lowed by pulsatile ‘‘crackling’’ tinnitus in 76.9%. Possible ously complained PET symptoms was re-inserted with
etiologies of PET included weight loss (53.8%), allergy TTA for the 4th time with the thickest, 16 gauge,
(23.1%), laryngopharyngeal reflux (11.5%), and autoim- angiocatheter wrapped up with a tragal perichondrium
mune disease (3.8%). Three patients (11.5%) developed to nearly close the ET passage. The final diameter of
PET symptoms with unknown etiology. The mean conser- angiocatheter wrapped up with a tragal perichondrium
vative treatment period before TTA surgery, which was approximately 2 mm. The patient showed no signs of
included lifestyle modification, medication, and minor recurrence or complication during the 8-year follow-up
surgical intervention, was 7.2  13.2 months (range, 3– period after the final surgery.
72 mo). Enrolled patients were followed up for 37.7  The most common complication after TTA insertion
36.2 months on average (range, 1–115 mo). was otitis media with effusion (OME) (n ¼ 10, 31.3%),
followed by tympanic membrane (TM) perforation (n ¼ 3,
9.4%), and TM retraction (n ¼ 1, 3.1%). Seven patients out
of 10 patients who developed OME during the follow-up
period were resolved of their symptoms spontaneously
within 3 months; the remaining three patients eventually
underwent ventilation tube insertion. All three patients
with TM perforation received a paper patch at the perfo-
ration site as soon as it was confirmed. All TM perforation
cases were resolved within 6 months. One patient com-
plained of severe foreign body sensation after severe acute
sinusitis and showed recurrent otitis media with intermit-
tent otorrhea. The patient’s TTA was removed 3 years after
the insertion. No patient showed major complications
intra-operatively or postoperatively, such as foreign body
FIG. 3. The age distribution of enrolled patients shows 2 clusters; reaction. The incidence of complications was not statisti-
the first cluster in the 20s to 30s, the second cluster in the 50s and cally related to the gender of the patients ( p ¼ 0.474) nor
above. the gauge of inserted TTA ( p ¼ 0.417).

Otology & Neurotology, Vol. 42, No. 9, 2021

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e1276 J. M. PARK ET AL.

PET symptoms due to the anatomical changes in the


structure or function of the Eustachian tube secondary to
rapid growth and development.
An interesting clinical feature of this study is that more
than half of the enrolled patients were in their 20s to early
30s. The possible etiology of PET in most of these young
patients was weight loss. It is well known that elderly
patients can develop PET symptoms after progressive
weight loss and soft tissue sagging due to chronic dis-
eases or the aging process. The weight loss in these
younger patients was mostly self-induced with a strict
diet and vigorous exercise routine for better body shape.
Various therapeutic methods have been suggested for
FIG. 4. The autophony scores after TTA shows improvement in
92% of the enrolled patients. TTA, transtympanic tripod-shaped
patients with PET. Conservative methods include reassur-
angiocatheter. ance, lifestyle guidance such as Valsalva’s maneuver with/
without weight gain, and discontinuation of decongestant
and/or nasal steroid sprays. Several medications such as
At their final follow-up visit, 92% of the 27 cases topical estrogen, saline, or anticholinergic nasal sprays,
followed up for more than 6 months showed relief from and insufflation with boric or salicylic acid have been
autophony after TTA insertion, according to Poe’s reported to alleviate symptoms of PET (8–10). As for the
autophony scoring system (Fig. 4). Mean PET distress intractable PET cases that do not respond to either conserva-
scores assessed by 5-item questionnaires decreased sig- tive treatment of medication, simple procedures such as
nificantly from 28.84  10.02 points preoperatively to placing a paper patch on the tympanic membrane to prevent
10.95  8.22 points postoperatively ( p ¼ 0.004) in 19 tympanophonia due to vibration (11,12), or inserting venti-
patients who completed the questionnaires (Fig. 5A). lation tube insertion to suppress the sense of pressure (13)
The individual trend lines of the average PET distress may be effective to control troublesome symptoms.
scores of each patient are illustrated in Figure 5B. More invasive procedures include tensor veli palatini
muscle modulation and the ET occlusion using various
DISCUSSION methods or materials. Irreversible modifications of the
ET by the transposition of the tensor veli palatini muscle,
The PET was first described by Schwartze in 1864, and surgical ligation of the tubal orifice, and cauterization of
the incidence has been known to be about 6% of the the tubal orifice using 20% silver nitrate or diathermy
population (2,8,9). The possible etiologies of PET are were reported to be effective but are no longer recom-
atrophy of peritubal fat tissue, loss of the pterygoid mended due to the possibility of complications (4).
venous plexus, and peritubal musculature dysfunction Several injection materials to narrow the lumen of the
associated with aging, chronic inflammation, weight loss, ET have been introduced to substitute such invasive
and pregnancy. Strenuous exercise is an important factor procedures, such as fat, collagen, Teflon (polytetra-
for the worsening of the symptoms, and resting in the fluoroethylene), calcium hydroxyapatite, etc. (14–16).
supine position may improve PET symptoms. Children Although injection techniques were assumed to be more
and teenagers may show spontaneous improvement of accessible and safer than more invasive surgical techni-
ques, complications due to foreign body reactions
occurred with nonabsorbable materials, and the effects
were temporary with absorbable materials (4).
As for the insertion technique to occlude the ET,
Ogawa et al. infused gelatin sponge into the ET through
a transnasal approach and showed 73% symptom resolu-
tion in 16 patients with PET back in 1976 (17). More
recently, Poe reported the use of autologous cartilage
grafts via endoscopic transnasal or transoral approach
with a 93% success rate in 11 intractable PET patients
(2). The first transtympanic approach to restore tubal
competency was reported by Bluestone and Cantekin in
which the ET was occluded with a catheter-like plug
known as a ‘‘shim’’ (18). Kobayashi et al. designed a new
FIG. 5. (A) Mean PET distress scores assessed by the 5-item silicone plug, a ‘‘Kobayashi plug’’ for its transtympanic
questionnaires decreased significantly from 28.84  10.02 points
preoperatively to 10.95  8.22 points postoperatively. (B) The insertion to the bony orifice of the ET, and reported an
individual trend lines of the average PET distress scores show 83% success rate in a large cases series of 252 patients
the alleviation of PET symptoms in most of the patients. PET, (19). In order to substitute commercially unavailable
patulous Eustachian tube. Kobayashi plug, we have designed our bone wax filled

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TRANSTYMPANIC ANGIOCATHETER INSERTION FOR PATULOUS EUSTACHIAN TUBE e1277

angiocatheter and reported it previously as a case study in to the rarity of the disease. Moreover, although the
2014 (7). Kong et al. have also reported a success rate of longest follow-up was up to 115 months, 5 of the 32
83% using similarly formed ‘‘Y-shaped’’ or ‘‘folded tip’’ enrolled cases were followed up under 6 months after the
angiocatheters with relatively few complications (8). TTA insertion. Lastly, the 5-item questionnaire PET
Our specially shaped TTA has several advantages: 1) distress instrument that was used to assess the changes
The main material of TTA is a typical plastic angiocath- in PET symptoms was not officially validated. Future
eter, which is readily available in medical institutions studies are in progress to validate the PET questionnaire
where the commercially made Kobayashi plugs are used in this study.
unavailable. It is also cost-friendly and biocompatible.
The modern angiocatheter consists of synthetic polymers CONCLUSION
such as polytetrafluoroethylene or fluorinated ethylene
propylene, which are the main property of permanent TTA insertion is a relatively simple procedure that can
stents and implants that are used in various parts of the be performed in a short period under local anesthesia.
body, particularly for vessel reconstruction. Also, bone Surgical intervention of TTA insertion for patients with
wax used to fill the lumen of the angiocatheter is strongly intractable PET symptoms seems promising, with a high
hydrophobic and minimally resorbable (20). Therefore, success rate and a low rate of complications even in a
the inserted TTA can be considered semi-permanent and long-term follow-up period.
does not need to be removed or replaced unless there is a
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