Innovative regenerative Innovative regenerative treatment treatment for for the tympanic membrane the tympanic membrane perforation perforation New York University, May 5 New York University, May 5 2011, New York, USA 2011, New York, USA Shin-ichi Kanemaru, M.D., Ph.D. 1) Hiroo Umeda, M.D. 2) , Yoshiharu Kitani, M.D. 2) , Satoshi Ohno, M.D. 2) , Tsuyoshi Kojima, M.D. 2) , Tatsuo Nakamura, M.D., Ph.D. 3) , Shigeru Hirano, M.D., Ph.D. 2) , Juichi Ito, M.D., Ph.D. 2) 1) Department of Otolaryngology–Head and Neck Surgery, Medical Research Institute, Kitano Hospital, Osaka, Japan 2) Department of Otolaryngology–Head and Neck Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan 3)Department of Bioartificial Organs, Institute for Frontier Medical Sciences, Kyoto University, Kyoto, Japan Medical Research Institute Kitano Hospital
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Innovative regenerative treatment for the tympanic membrane perforation New York University, May 5 2011, New York, USA Shin-ichi Kanemaru, M.D., Ph.D.
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1) Department of Otolaryngology–Head and Neck Surgery, Medical Research Institute, Kitano Hospital, Osaka, Japan2) Department of Otolaryngology–Head and Neck Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan3)Department of Bioartificial Organs, Institute for Frontier Medical Sciences, Kyoto University, Kyoto, Japan
Medical Research InstituteKitano Hospital
Disadvantages of TM perforation?Disadvantages of TM perforation?
Background
Hearing loss, Decline of Hearing loss, Decline of speech speech articulationarticulation
Easy and recurrent infection Easy and recurrent infection
Tinnitus, aural fullness and etc. Tinnitus, aural fullness and etc.
Restrictions of daily life activities Restrictions of daily life activities
Cancellation effectCancellation effect
Collision of sounds in the cochlea
Collision of sounds in the cochlea
Rapid attenuation of energy
Greatest disadvantage of TM
perforation
Greatest disadvantage of TM
perforation
Large TMP often causes over 50dBHLLarge TMP often causes over 50dBHL
Hearing aid amplifies the "cancellation effect" Hearing aid amplifies the "cancellation effect"
conversation : 40-60dB50dBHL Hearing Aid
What are the present treatments of TM perforation ??
What are the present treatments of TM perforation ??
Necessity of skin incision and harvest of auto-tissue
After 3 weeks After 3 weeks Disruption of the perforation edgeDisruption of the perforation edge
Patients who are susceptible Patients who are susceptible to this treatmentto this treatment
Dry TM and tympanic cavity without active inflammation during the previous 3 yearsProper aeration and no regions of soft tissue density in the mastoid and tympanic cavities based on Temporal bone CTs Intact ossicular chains
No cholesteatoma and no invasion of epithelia into tympanic cavity
Patients Patients
Patients/ears: n=140/158 (M/F:59/81), Age: 10-91
Causes of b-FGF group Control group TM perforation n=148 n=10
Subtotal perforationSubtotal perforationDisruption of the perforation edgeDisruption of the perforation edgeGelatin Sponge with b-FGFGelatin Sponge with b-FGF
Case 1. Case 1. 65y.o. male OMC for 65y.o. male OMC for 30years30years
After 3 weeksAfter 3 weeks After 4 months After 4
months After 4 monthsAfter 4 months
Hearing LevelBefore: 61dB After: 33dB
0.125 0.250 0.5 1 2 4 8 kHz
3 months after
Before treatment
dB0
10
20
30
40
50
60
70
80
90
100
Conversation range
Case 2. 39-y.o. female
After 1 month
Total perforation after TM tube insertion
After 3 months
Hearing Level Before: 50dB After: 10dB
3 months after
Before treatment
dB0
10
20
30
40
50
60
70
80
90
1000.125 0.250 0.5 1 2 4 8 kHz
Overall Results of b-FGF group
Grade I : PS<1/3, Grade II:PS 1/3 ~ 2/3, Grade III : PS>2/3 NA: Average hearing level of 0.5, 1 and 2 kHz
LA: Average hearing level of 0.125, 0.25 and 0.5 kHz *TO: Temporary otorrhea **RTM: Retraction of tympanic membrane
***Chole: Cholesteatoma
Classification by Grade I Grade II Grade III perforation size (n=37) (n=64) (n=47) Number of times 1-3 1-4 1-4 for treatment ( Ave. ) (1.31) (1.31) (1.95) Closure rates 94.6 % 85.9 % 83.0% (35/37) (55/64) (39/47) Improvement NA:14.1dB 20.6dB 24.5dB of the ave. HL LA :28.7dB 31.1dB 35.3dB
No skin incision and no harvest of autologous tissues Wide application for various kinds/sizes of the TM perforation including total perforations
Only 10 minutes simple/easy treatments for outpatients
Ideal hearing up and tinnitus reduction immediately after the treatment No restrictions of the patient’s daily life No severe sequelae and no disadvantages
Cost-effective and alleviation of mental and physical burdens of the patients
No skin incision and no harvest of autologous tissues Wide application for various kinds/sizes of the TM perforation including total perforations
Only 10 minutes simple/easy treatments for outpatients
Ideal hearing up and tinnitus reduction immediately after the treatment No restrictions of the patient’s daily life No severe sequelae and no disadvantages
Cost-effective and alleviation of mental and physical burdens of the patients
Remarkable advantages
Summary
This study demonstrated that the combination of a gelatin sponge, b-FGF and fibrin glue was effective for regeneration of the TM perforation.
This is the innovative regenerative therapy: easy, simple, cost-effective and minimum-invasive treatment for outpatients.
Our dream coming true!
Medical Research Institute Kitano Hospital, Osaka, Japan
Hybrid Tympanoplasty
Tympanoplasty TM regeneration
safety sequelae
Hearing improvement
cost-effective
adaptation
Background
What is the Hybrid Tympanoplasty?
After mastoidectomy and posterior tympanotomy,cleaning of the tympanic cavity through mastoid cavity
No need to harvest of temporal fascia for No need to harvest of temporal fascia for reconstruction of TMreconstruction of TM
No need to exfoliate soft tissue of EAM and TM No need to exfoliate soft tissue of EAM and TM
To perform regeneration of the TM though external auditory meatus
I II
MastoidectomyPosterior tympanotpmy
III
Regeneration of MACs
IV
Regeneration of TM
Procedures of Hybrid Tympanoplasty
Merits of the Hybrid Tympanoplasty
Day or short stay surgery.
Minimum sequelae are associated with this procedure because of no
Restrictions are not placed on the patient’s daily life.
There are low risks of damage to chorda tympani nerve.
It is possible to fully regenerate normal TM morphology and to improve hearing up to maximum level.
Wide renge of applications.
Adaptation of Hybrid Tympanoplasty
Chronic otitis media
No adaptation for cholesteatoma, adhesive otitis media