ENDOSCOPIC FAT GRAFT MYRINGOPLASTY
WITH EVICEL(SEALANT) APPLICATIONS
DR.K.K.DESARDA
A prospective study at KEM Hospital Pune
Abstract:
The aim of endoscopic fat
graft myringoplasty (FGM) under local anaesthesia clinical trial was to evaluate the success
rate of our newly developed surgical technique We also aimed to assess the
correlations between the size of perforations and closure rates, as well as the
results of re-gained hearing in successful cases with respect to sizes of
perforations. Fifty consecutive patients with persistent tympanic membrane
perforation were included in this study. All patients underwent endoscopic fat graft myringoplasty with evicel
(Human selant fibrin glue) .application.
Treatment success was defined as an
intact and mobile tympanic membrane (TM) at the 3-month follow-up visit. Bone
conduction (BC) and air conduction (AC) thresholds at the frequencies of 0.5,
1, 2, 3, and 4 kHz were recorded preoperatively and at the 3rd month
postoperatively.
The fat graft tympanoplasty
can be performed under local anesthesia . The harvesting of the graft is very
quick and there is no visible scar and minimum donor site morbidity. It
avoids extensive middle ear manipulation. It is a safe and simple
procedure for the closure of a dry, small central perforation. Its
success rate is as good as tympanoplasty using temporalis fascia or
perichondrium.The success rate is 98 to 100% for small central perforations.A fat graft myringoplasty achieves its highest
success rate in perforations smaller than 30% of the pars tensa.We strongly recommend
the endoscopic fat graft myringoplasty procedures for small central perforations which achieves
98% graft take up with 15 db air bone gap closure.
.
Key Features:
Endoscope,fat graft, evicel sealant glue,.myringoplasty
INTRODUCTION:
A prospective clinical study of endoscopic fat graft myringoplasty for small central tympanic membrane perforations due to:
trauma, infection, post-tympanostomy tube extraction and post myringoplasty
residual perforations was carried out at KEM and Sahyadri speciality Hospital Pune during
2014 to 2015. Fifty cases of fat graft myringoplasties were done using evicel
selant ( J & J co. ltd ) application .The post op results were excellent
about (98%) were analysed.Temporalis
fascia and perichondrium
use to be the most common grafts being used in closure of the tympanic
perforations. However for a dry, small central perforation the adipose
tissue fat is a good alternative.
A
myringoplasty is one of the most common operations performed in Otosurgery, due
to the high incidence of tympanic membrane perforation. The first attempt
to close the tympanic perforation was done by Banzer in 1640 who inserted a
small tube of elkhorn covered with pig’s bladder.1 Berthold in
1878 used a full-thickness free skin graft for tympanic membrane closure.2
Ringenberg used a fat tympanoplasty for the first time for the closure of a
small tympanic perforation.
The fat graft tissue tympanoplasty has certain
advantages as this procedure can be done in an office basis or on an outpatient
basis. The patient goes home on the same day. There is very limited
postoperative care. Fat can be harvested in a very short time and it
avoids invasive extensive surgical manipulation of the middle ear. It
avoids general anesthesia and is very safe for a dry, small, central
perforation. It is a simple and cost effective technique in managing
small tympanic membrane perforation and the success rate of a fat-plug
myringoplasty is comparable with the results of temporalis fascia
tympanoplasty.
Fifty patients aged between 20 to 55 years;
with fat graft myringoplasty were operated endoscopically for closure of
tympanic membrane perforation at KEM and
Sahyadri speciality Hospital Pune during 2014 to 2015 under local anaesthesia
Follow up visits for tympanic membrane evaluation, were in the 1, 3, 6 and 12th
post-operative months. Failure cases were counted at the end of the 1st month
post-operatively. Hearing evaluation was done pre-operatively and in the 4th
postoperative month. Closure of the air bone gap was the parameter of hearing
improvement. The outcome measures were the post-operative state of tympanic
membrane, hearing improvement in closure of the air-bone gap and incidence of
failures and complications.Three groups of the patients were selected for fat
graft myringoplasty procedure The groups included. Were residual
perforation,traumatic perforations and post grommet extrusion perforations.All
perforations were small central type with minimum conductive hearing loss.
The Mean operative time was 30
minutes. No side effects or operative complication occurred during the
procedure.The successful procedures were (98%) from the entire patient group.
Post-operatively, the mean improvement in the air/bone gap was about 15 dB for
the successful cases.
Materials and Methods:
A retrospective study was done in the Department of Otorhinolaryngology,
KEM and Sahyadry Hospital Pune during 2014 to 2015, to evaluate myringoplasty
using only fat (adipose tissue) to close the eardrum perforation.
All the surgeries were done by the first author. A total of 50 cases that
underwent consequent fat-plug myringoplasty were included in the study.
30 adult male and 20 female patients were selected for this procedure under
local anaesthesia.The children age group was excluded from this study because
of their recurrent URTI and Eustachian tube dysfunction.
The perforation was situated in the anterior
inferior quadrant in twenty cases,and posterior inferior quadrant in thirty
cases . The criteria for the small perforation was that the size of the
perforation be approximately 5 by 5 mm or 25 to 30% of the drum's
surface .Free fat grafts
have been known to reduce in size during long-term follow up. This is the
reason why the grafts used were approximately two times larger than the size of
the perforation. In this study subtotal and total perforations were excluded. The subsequent
otoendoscopic evaluation revealed closure of the perforation which was
considered as successful criteria for a fat-graft myringoplasty. The subsequent post.op. audiometric
evaluations were done and compared with pre.op.audiometrtic profie which
revealed closure of AB gap bt 15db.
Surgical
Technique:
Endoscopic
Transcanal transtympanic approach without raising
tympanomeatal
flap:
Graft Harvesting:
The ear
lobe was infiltrated using 2% lidocaine with 1:200,000 adrenaline and a
5 mm incision was made at the medial surface of the tip of the ear lobe
with no. 15 blade. The skin was undermined and an amount of fat as twice as the
size of the perforation was harvested in one piece and was put in a sterile
saline solution. The incision was closed by one or two 5–0 absorbable sutures(Fig.1)
With 4
mm zero degree endoscopic vision, the
edges of perforation were freshened. The middle ear was filled with antibiotic
soaked gelfoam.The fat was trimmed at an approximately twice the size of the
perforation or lesser. It was placed over the perforation and plugged in it as
an hourglass through the perforation using a pick or blunt needle. The lateral
fat bulge should not be too high to help epithelial closure of the perforation.
Oversized fat plug may cause a tear in the tympanic membrane or overstretching
of the perforation margins leading to atrophy or necrosis later on. Undersized fat plug
should be avoided to prevent dehiscence in grafting .The graft was kept
humidified by pieces of gelfoam upon and around the outer portion of the fat
and stabilized by using a thin film of evicel selant (human fibrin glue)
covering the tympanic membrane. The external ear was filled with pieces of
gelfoam soaked with local antibiotic drops
The external ear opening is sealed with a merocel ear pack. No ear
dressing was used. The merocel pack was removed after 48 hrs.
The sequential pictures
of fat graft myringoplasty:
Fig.1
Fat graft harvesting from post.surface of ear lobule.
Fig.2 Endoscopically freshening of edges of perforation of Small CP
Fig.3 Endoscopically
Fat plugging of the perforation
Fig
.4 Gelfoam packing & Evicel glue
application
Geifoam packing
Fig.5. Endoscopic fat graft
pictures pre & post operation
after 8 wks
A)
Pre op central perforation. B) post op fat graft as neotympanum
graft myringoplasty
1. Period of time elapsed from
previous surgery equal to or longer than 6 months.
|
2. Perforation of the pars tensa
no larger than 5 mm.
|
3. Non-marginal localization, i.e.
not involving the annulus or exposing the
malleus handle.
|
4. Absence of calcific plaques or
atrophic areas adjacent to the perforation.
|
5. Normal appearance of mucosa in
the tympanic cavity.
|
6. Absence of any acute
inflammation.
|
7. Absence of middle ear discharge
in last 3 months.
|
8. No evidence of cholesteatoma.
|
9. No planned ossicular
reconstruction.
|
10. Absence of major Eustachian
tube dysfunction.
|
Results
Fifty patients were included in this endoscopic study, fourty two patients had unilateral, while eight patients
had bilateral perforations.who had fat graft myringoplasty. The eight bilateral
perforation cases were all due to post-long term tympanostomy tube extraction
and the selection of which ear to be operated upon was the ear with a larger
air bone gap. If both air bone gaps are equal, the larger perforation was
operated first. The second ear was operated upon after 3 months of
complete healing of the 1st ear.
There was no side effect or complication at the time of the
procedures. The mean operative time for the procedure counted from the beginning
of the marginal refreshing of the perforation to closure of external ear canal
by merocel pack was 30 min.
Fat graft myringoplasty procedure has a
minimal technique failure especially if the selection criteria were applied to
the patients for this surgery. All cases had evicel selant(Fibrin glue )
application for graft take up.The graft take up was 98% in all cases and failure
cases were 4%.The advantages of fat
graft include: It does not need support from the middle ear side to prevent
collapse like underlay grafts especially at the area near the anterior annulus.
Discussion
Ringenberg first described FM, with a success
rate of 87% for small perforations. [Since then, studies have shown success rates ranging
from 85% to 92% in cases of small perforations. Deddens et al. had reported that size of
TM perforation was a crucial factor. Perforations, in their series, were 5-30%
of the drum surface, which was a good prognostic factor for an FM as compared
to larger perforations for fat graft alone as was also observed by us.
The fat graft can be harvested from the abdomen, buttock and ear lobule. The ear lobule fat harvesting is much simpler as it is done from the same sterile area of the surgical field prepared for the fat tympanoplasy and its scar is almost invisible. The fat of ear lobule is denser with big revascularization activity and acts as a good template for mucosal and epithelial growth. There is significant bulging postoperatively on the TM till the end of the 3 rd month and after that it progressively disappears and gets converted into a smooth sclerotic area on the TM at the 5 thmonth . This phenomenon was also observed by us in patients where graft uptake was there. There are two histological theories of fat grafts."The host cell replacement theory" of Neuhof and "The cell survival theory" of Peer. The host cell replacement theory states that all the original cells die and are totally replaced by new wondering adipocytes or by fibroblasts. The cell survival theory states that not all the original adipose cells die. Those fat cells which receive adequate blood supply survive whereas remaining degenerate, thus explaining loss of volume. The transplanted fat cells are not replaced by scar tissue, instead a connective tissue capsule outside the fat graft begins 3 weeks after transplantation, which becomes progressively thinner over the course of a year. Fat tissue provides the basic requirement for the grafting of the TM with its own favorable characteristics.
The fat graft can be harvested from the abdomen, buttock and ear lobule. The ear lobule fat harvesting is much simpler as it is done from the same sterile area of the surgical field prepared for the fat tympanoplasy and its scar is almost invisible. The fat of ear lobule is denser with big revascularization activity and acts as a good template for mucosal and epithelial growth. There is significant bulging postoperatively on the TM till the end of the 3 rd month and after that it progressively disappears and gets converted into a smooth sclerotic area on the TM at the 5 thmonth . This phenomenon was also observed by us in patients where graft uptake was there. There are two histological theories of fat grafts."The host cell replacement theory" of Neuhof and "The cell survival theory" of Peer. The host cell replacement theory states that all the original cells die and are totally replaced by new wondering adipocytes or by fibroblasts. The cell survival theory states that not all the original adipose cells die. Those fat cells which receive adequate blood supply survive whereas remaining degenerate, thus explaining loss of volume. The transplanted fat cells are not replaced by scar tissue, instead a connective tissue capsule outside the fat graft begins 3 weeks after transplantation, which becomes progressively thinner over the course of a year. Fat tissue provides the basic requirement for the grafting of the TM with its own favorable characteristics.
The transcanal approach seems to be safer for the
patient in comparison to the classic myringoplasty techniques since no
manipulations of the middle ear are performed and the related complications are
avoided. Fat is not the only material used when the tympanic membrane is
approached via the external auditory meatus but it is somewhat easy to harvest
and handle. Dursun et compared the
effectiveness of perichondrium and fat in repairs of perforations smaller than
3mm in 30 patients and found no statistically significant differences in the
use of the two techniques. In fat subgroups, 2mm and 3mm perforations had an 90%
success rate and 1mm perforations a 100% success rate again equal to the
perichondrium results
Free
fat grafts have been known to reduce in size during long-term follow up. This
is the reason why the grafts used were approximately two times larger than the
size of the perforation. Nishimura et observed in an experimental study that
apoptotic cells were present 30 days after transplantation.
Although fat graft myringoplasty is a simple, safe and
cost-effective procedure, it has been underused despite its numerous
advantages.7 However, it cannot be always an alternative procedure to
the classic surgical myringoplasty in every tympanic membrane perforation.
Certain clinical criteria should be fulfilled and applied for the perforation
to have the highest possibility of this procedure’s success
The clinical criteria
established by Fiorino and Barbieri for admission to fat graft myringoplasty
were sufficient for the selection of patients eligible for this procedure ..
The first utilization of fat plug myringoplasty was reported by
Ringenberg8 with the success rate of 90%. In the following studies the success
rate was ranging from 80% to 92% in cases of small perforations including
primary procedures. In this study, the success rate of the entire group of
patients was 98%.
.
The failure rate for this study was 4 out of 50 ears (8%) with a
mean air bone gap of 10 dB and the causes were due to infection, detached
fat graft and dehiscence due to undersized grafts. Fiorino and Barbieri
attributed the failure causes to: immediate failures due to technical
difficulties such as anterior perforations, inadequate graft support, poor
vascular supply or infection; and delayed failures due to tympanic membrane
atrophy, infections or Eustachian tube dysfunction. Fat graft myringoplasty
procedure has a minimal technique failure especially if the selection criteria
were applied to the patients for this surgery. All cases had evicel selant(Fibrin
glue ) application for graft take up.
Local anaesthesia was used in most of the literature as the
procedure is easy, simple, fast and minimally invasive.
In this study, the traumatic,
the tubotympanic chronic otitis media, the post tympanostomy tube extraction
perforation groups were operated upon after 3 months of dryness and
failure of closure, while the post myringoplasty residual perforation cases
were operated upon after 6 months of failure of closure.
Technical operative
points during fat grafting (such as graft size in the perforation, degree of
lateral bulge of the fat plug and moistening of the lateral side of the graft
are also considered to be important factors of success in the fat grafting
procedure.
Fat is also an active material containing angiogenic and
survival factors e.g. Monobutyrin, prostaglandins, interleukins 1 and 6,
cytokines and tumour necrosis factor which, stimulate restoration and repair of
the fibrous layer and promote revascularization which are both essential for
survival of the free flap. Fat graft promotes growth factors including
vascular endothelial growth factor, transforming growth factor beta, platelet
derived growth factor and fibroblast growth factor which promote the process of
the tissue repair. Fat contains high population of multipotent cells referred
as adipose-derived stem cells which are similar in activity to those of the
bone marrow derived mesenchymal stem cells in the ability to differentiate into
mesenchymal tissues such as endothelial and fibrous types promoting the healing
process of the tympanic membrane.
Conclusion
Fat graft
myringoplasty is an easy, simple, fast and minimally invasive procedure for the
repair of small tympanic membrane perforations with favourable hearing results.
It can be performed under local . It can be done for small tympanic membrane
perforations due to: trauma, infection, post tympanostomy tube extraction and post
myringoplasty persistent residual perforations with good success rate without
complication
The evicel sealant
(Ethicon J&J co.Ltd) applied as thin film gets absorbed in two weeks
leaving the neo-tympanum intact because of its adhesive properties.We strongly
recommend this endoscopic fat graft
myringoplasty procedures for small
central perforations which achieves 98% graft take up.A fat graft myringoplasty achieves its highest success rate
in perforations smaller than 30% of the pars tensa. Tympanosclerosis should not
be a contraindication for fat grafting.
References
1.Ringenberg JC. Fat graft tympanoplasty. Laryngoscope. 1962;72:188-192
2.Sterkers JM. Ultra-thin adipogenic graft for
tympanoplasty (obtained by crushing subcutaneous adipose tissue under pressure)
[in French]. Ann Otolaryngol Chir Cervicofac. 1964;81:265-270
PubMed
PubMed
3,Terry RM, Bellini MJ, Clayton MI,
Gandhi AG. Fat graft myringoplasty—a prospective trial. Clin Otolaryngol Allied Sci. 1988;13(3):227-229
PubMed | Link to Article
PubMed | Link to Article
4.Gross CW, Bassila M, Lazar RH, Long TE,
Stagner S. Adipose plug myringoplasty: an alternative to formal
myringoplasty techniques in children. Otolaryngol Head Neck
Surg. 1989;101(6):617-620
PubMed
PubMed
5.Landsberg R, Fishman G, DeRowe A, Berco E,
Berger G. Fat graft myringoplasty: results of a long-term
follow-up. J Otolaryngol. 2006;35(1):44-47
PubMed | Link to Article
PubMed | Link to Article
6. Landsberg R, Fishman G, DeRowe A, et al. Fat
graft myringoplasty: results of a long-term follow-up. J. Otola
7.Terry RM, Bellini MJ, Clayton MI, et al. Fat graft myringoplasty
– a prospective trial. Clin. Otolaryngol. Allied Sci. 1988;13:227–229. [PubMedryngol. 2006;35:44–47. [PubMed]
8.Bertoli GA, Barbaro M, Giangande V, Bava G, Seta ED, Filipo R. Fat
graft myringoplasty: An office procedure for the repair of small perfoations of
the tympanic membrane. Mediterr J Otol 2007;3:120-5. 