Saturday, 29 August 2015



Fibrin sealant has been used for many years and has a wide range of clinical applications for suture support, tissue adhesion, and hemostasis. Fibrin sealant imitates the final phase of the blood coagulation process. Fibrinogen is converted to fibrin on a tissue surface by the action of thrombin, which is then cross-linked by factor XIIIa, creating a mechanically stable fibrin network. This fibrin network is thought to reduce the amount of postoperative bleeding by sealing capillary vessels and enabling raw operative surfaces of cartilage graft to adhere. The potential advantages of the use of such substances include prevention of hematoma, reduction in surgical time, reduction in flap edema, and shorter recovery time andexcellent healing. The physiologic mechanism that creates fibrin sealant was first described by Morawitz in 1905.

 We have reviewed the world literature to find out if any study in micro-ear surgery is done but could not find any confirmed study. Ours is the first pilat study to know the efficacy of evicel sealant in reconstructive tympanoplasty. Fibrin glue was originally described in 1970 and is formed by polymerizing fibrinogen with thrombin and calcium.2 It was originally prepared using donor plasma; however, because of the low concentration of fibrinogen in plasma, the stability and quality of the fibrin glue were low.3 Commercially pretreated fibrin sealant products were developed to increase the efficacy of forming a stable clot.These products are heat treated, which greatly reduces the risk of disease transmission. The fibrin sealant and delivery system are easy to store and rapid to construct, and, therefore, have enjoyed some use in  reconstructive tympanoplasty and cosmetic surgery.

Fibrin sealant (human) (Evicel; Johnson & Johnson– Wound Management, Somerville, New Jersey) is a plasma cryoprecipitate-based sealant that consists of 2 components: (1) biological active component–2 (BAC2), also called human clottable protein, which consists predominantly of fibrinogen and (2) thrombin. BAC2, a concentrated solution of clottable plasma proteins, consists mainly of fibrinogen and other proteins. The thrombin solution contains highly purified human thrombin and calcium chloride for activation of clotting of the final combined product. Thrombin is a highly specific protease that transforms the fibrinogen contained in BAC2 into fibrin. Fibrin sealant (human) (Evicel; Johnson & Johnson– Wound Management, Somerville, New Jersey) is a plasma cryoprecipitate-based sealant that consists of 2 components: (1) biological active component–2 (BAC2), also called human clottable protein, which consists predominantly of fibrinogen and (2) thrombin. BAC2, a concentrated solution of clottable plasma proteins, consists mainly of fibrinogen and other proteins. The thrombin solution contains highly purified human thrombin and calcium chloride for activation of clotting of the final combined product. Thrombin is a highly specific protease that transforms the fibrinogen contained in BAC2 into fibrin. It is indicated as supportive treatment in patients undergoing reconstructive tympanoplasty.


u  Thaws within 10 minutes at 37°C (and must not be kept at this temperature for longer than 10 minutes); within 1 hour at 20°C to 25°C (room temperature); or within 1 day at 2°C to 8°C (refrigerator). Once thawed, EVICEL® must not be refrozen. Once at room temperature, EVICEL® must not be refrigerated
u  All-Human formulation – EVICEL® Fibrin Sealant does not contain aprotinin or bovine derivatives and does not expose patients to the risks associated with aprotinin264
u  Multiple, clog-resistant tip options – Standard 6 cm tip or 35 cm Rigid or 45 cm Flexible tip.


u  Do not inject directly into the circulatory system. Intravascular application of EVICEL® may result in life-threatening thromboembolic events.
u  Do not use in individuals known to have anaphylactic or severe systemic reaction to human blood products.
u  Do not use for the treatment of severe or brisk arterial bleeding
            Most common adverse events reported in clinical trials (=5%) are bradycardia,  
            nausea, hypokalemia, insomnia, hypotension, pyrexia, graft infection, vascular  
            graft occlusion, peripheral edema, and constipation.

Evicel is provided as a single-use human surgical sealant kit consisting of 2 packages, the first containing 1 vial each of frozen sterile solutions of BAC2 (Biological Active Componant 2) and thrombin and the second containing the sterile application device. It is the only totally human protein–derived, bovine-free fibrin sealant commercially available in the United States. The unit cost for 2 mL of fibrin sealant plus the applicator is $200(1Rs.12000). The vials are stored in a freezer; when removed and thawed, they are stable for 24 hours. The vials are readily thawed in 5 minutes without the use of a rapid-warming device. After the BAC2 and thrombin solutions are thawed, they are drawn into a unique trilumenal (2 syringe lumens and 1 air lumen for spraying) catheter application device. As the plungers are depressed simultaneously, the solutions are mixed by the applicator and sprayed into the operative site.

The applicator gently sprays the fibrin sealant into the operative wound as a thin layer and, therefore, allows a relatively small volume (1 mL) of sealant to be delivered evenly. The solutions mix as they exit the catheter during administration, are applied topically by dripping and once applied are transparent. The reconstituted preparation mimics the final steps in physiologic coagulation. Fibrinogen is converted to fibrin on the wound surface in presence of calcium ions by the actions of thrombin and factor XIII, all derived from human plasma. A stable cross-linked fibrin clot is formed over the neotympanum.

Recently we have done 50 cases of type one tympanoplasties with inlay composite cartilage graft. After the surgical procedure is over the evicel (1.5 ml) solution is applied over the surface of the graft material by the evicel triluminal applicator and it was kept for over 3 to 5 minutes to form a solid layer over the neotympanum. So far 50 casers being treated with this technique and found to be excellent in graft take up (98%) and without medialization or lateralization . No complications encountered during evicel application. Graft take was 98% post operatively. More study will be required for its efficacy in reconstructive tympanoplasty.We plan to do more cases with varied middle ear pathology like ossiculoplasty, ossiousplasty ( Bony defect reconstruction as attic, defect, PSQ defect and canal wall defect. Its effect on graft fixing is very encouraging which inspired us to take up this study in middle ear reconstruction.


u  The results were evaluated in the form of graft uptake, hearing outcome and complications.
u  Healed neo-tympanic membrane, which moves on seigelization was taken as successful graft take-up, while any residual perforations or retraction of neo-tympanum were taken as failures.
u  Postoperative and preoperative pure-tone audiograms were compared. Hearing gain and mean residual gaps were evaluated in speech frequencies of 500, 1000, and 2000 Hz.


u  Reduction in the graft displacement as a cause of failure
u  Ease of use. Comes with the application device and is easy to set up and ready to use.
u  Works on all types of grafts so your primary surgery does not need any alterations.
u  Application takes just an extra few minutes at the end of the surgery.


u  Need for a longer study with more number of cases to prove its statistical significance
u  Affordability and Availability of the fibrin sealant.


u  A failure rate of around 10 % for a type 1 Tympanoplasty is still high by today’s standards.
u  The pilot study shows promising results.
u  Encourage ENT surgeons to use a fibrin sealant and publish your results and feedback regarding the same.

Tuesday, 21 April 2015

Robotic Surgery Applications in Otolaryngology & HNS An Emerging Wave.

Robotic surgery Applications in Otolaryngology & HNS

An Emerging Wave.


A role of Robotic surgery technology in otolaryngology is beginning to emerge, particularly where precision is required or visualization is limited, and there are a number of pioneering contributions. The first otolaryngologic application of robotics occurred as early as 2002 with several reports from the Terris group at the Medical College of Georgia exploring endoscopic neck procedures.7-10 The first human application was described by McLeod and Melder11 with a case report of excision of a vallecular cyst. Hockstein and colleagues further pursued oral and oropharyngeal applications of robotic technology with a stepwise experimental approach.12,13 Finally, interest in robotic skull base surgery has emerged with the work of Hanna and colleagues.14

Experimental Origins

The first use of robotics for otolaryngologic applications was explored in a porcine model of neck surgery that included parotidectomy, submandibular gland resection, and selective neck dissection.8 This work built on previous promising findings for totally endoscopic neck surgery (also described by Terris and collaborators15,16) and provided proof of principle, in that the safety and efficacy of endorobotic neck surgery was demonstrated, and quickly established that advantages in duration of surgery could be easily achieved with the addition of robotic technology.

Robotic-assisted surgery is poised to become a standard technique for many head and neck surgical procedures, according to experts. Robotics has already been approved for prostate surgery, heart surgery, gastric bypass, and hysterectomy. If preliminary results in early studies of some head and neck surgical procedures are borne out, transoral robotic surgery (TORS) should also be approved by the FDA
The purpose of these studies was to learn how to position the da Vinci arms in a patient's mouth, Dr. weinstein described robotic-assisted procedures as follows: the surgeon sits at a console where the surgical field is displayed in high-quality, three-dimensional video, and small joysticks are used to control the robotic arms. The patient is positioned remotely, approximately 10 feet away.

Figure.Transoral robotic surgery, offering a three-dimensional visual environment, is being studied for use in a number of head and neck procedures.


Several types of head and neck surgical procedures are amenable to robotic-assisted surgery. Robotics can be used to resect benign and malignant tumors of the oral cavity, including the pharynx and larynx, tonsil, tongue base, supraglottis, glottis, pyriform sinus, and the parapharyngeal space.
Transoral robotic surgery is presently ideal for cancers or benign tumors of the oropharynx and supraglottis, and this technique is also useful for tumors in the pyriform sinus, but access is more difficult. It should be used for tumors not lower than the vocal cords and not higher than the lower nasopharynx.
Robotic-assisted surgery has a potential use not only for treating benign and malignant tumors, but also for treating inflammatory conditions such as chronic lingual tonsillitis in the back of the tongue. When a patient complains of chronic tongue base tonsillitis that does not respond to antibiotics, it is a real problem for the patient and the surgeon  as it is difficult to remove the tongue base tonsils using standard techniques. At the University of Pennsylvania, preliminary studies in a few patients suggest that robotic-assisted surgery takes only about 15 minutes to remove the tongue base tonsils, and no further infections have been seen with long-term follow-up.



The benefits of TORS are numerous, according to surgeons interviewed for this article.
Some tonsil- or tongue-based cancers require large, complex, long operative procedures involving tracheostomy, complex skin reconstruction, and splitting the jaw, Dr. Weinstein explained. Blood transfusions are often required for these large open procedures. Only one patient who underwent TORS at the University of Pennsylvania required a blood transfusion, he commented.
We can avoid tracheostomy, complex skin reconstruction, and jaw splitting with robotics, using one three-hour procedure and then a second procedure for another three hours to take out lymph nodes.
Robotics causes less injury to speech and swallowing structures, and less cosmetic damage, because it is less invasive than open surgery. Also, robotics shortens surgical times from six to 18 hours to two hours. Robotics also allows good control of bleeding. With robotics, we can use both hands for surgical procedures, whereas endoscopic-based procedures are typically done with one hand, because the other hand holds the endoscope.
For other lesions, such as lesions in the supraglottis or larynx, the major advantages of robotics over open surgery are better access and faster surgical times.
Robotics offers a three-dimensional visual environment that puts the surgeon right where the surgery is happening. This unique perspective allows the surgeon to operate at the same level as the anatomy of interest. 'Master' control manipulators then allow the surgeon to use precise instruments in situations and in ways that were never before possible. For instance, the surgeon can rotate a given instrument 540 degrees and overcome the limitations of the human wrist.


One limitation of robotic-assisted surgery, with present techniques, is limited access. Some tumors are located too deep in the laryngopharynx to allow access, Dr. Weinstein said. With current technology, it is difficult to have greater access beyond present boundaries (i.e., tumors not lower than the vocal cords and not higher than the lower nasopharynx), Dr. O'Malley commented.
Also, at present there are no robotic instruments for drilling and removing bone. ENTs use a lot of drills, and it is expected that companies will be developing rongeurs and drills along with the software to drive these tools using the robot.
It would also be desirable to have haptic or tactile feedback with robotics, such as is used by the military. At present, we have to rely on the tremendous three-dimensional visualization for feedback. As we take the surgical robot into new frontiers, such as skull-based surgery, it would be advantageous to have a system for tactile feedback,
According to Dr. Holsinger, at present the CO2 laser is used with endoscopy to resect tumors and develop planes, but this has limitations. The ideal technique would combine the precise tissue handling properties of the CO2 laser with robotics. Research efforts are aimed at trying to find an optimal laser to combine with robotics, he said.


The first workshop and formal educational program in robotics for head and neck was taught by Drs. Weinstein and O'Malley at the Intuitive Surgery Training Facility in California. That course included a core group of 12 head and neck surgeons from several institutions, including the Mayo Clinic, M. D. Anderson Cancer Center, and Mount. Sinai Medical Center. These individuals, including Dr. Holsinger, have now gone back to their respective institutions to initiate IRB-approved studies of TORS. Drs. Weinstein and O'Malley are conducting an IRB-approved study at the University of Pennsylvania that is still open. Thus far, 120 patients have entered the trial, and only two of them had anatomy that was inaccessible for a robotic-assisted procedure.
If TORS gains FDA approval based on these studies, the University of Pennsylvania will offer a training course in robotics procedures. The plan is to have a two-day course, with one day in the laboratory and another day of observation. Other institutions will undoubtedly offer courses in robotics as well.
The University of Pennsylvania also plans to erect a special building for research and training in robotics, Dr. O'Malley said. We hope that the people we trained [at the first training session last year] will set up their own programs and spread the seed-establishing more research and developing new procedures and applications, he added.


In the future, it would be ideal to have smaller instruments to allow deeper access beyond presently defined boundaries, Dr. Weinstein said. Smaller instruments will be developed to allow access to the nasal cavity as an alternative to endoscopic surgery.
While the first TORS skull base surgery cases have been reported from the University of Pennsylvania, further miniaturization of instruments and more flexible instruments, tactile feedback, and techniques for skull based procedures will probably be developed.
 Dr. O'Malley saidtransoral approaches through the nose to the skull base are being studied in the cadaver model using robotic-assisted techniques. If skull base procedures can be done with robotics, surgery could carry much less morbidity.
Another pressing need, according to Dr. O'Malley, is two-handed, delicate, fine magnification procedures for the vocal cords or subglottis, which may also be applicable to skull base surgery. The technology is not there yet, but it should be in the next five or 10 years. The team at the University of Pennsylvania is studying robotic-assisted surgery for skull-based procedures. There is a need to refine and hone instruments for these procedures.
We are just at the beginning of discovering uses for robotics in head and neck surgery, similar to when DOS was the only operating system for computers. At present, robotics allows removal of tumor and provides a bird's eye view in areas that heretofore had difficult transoral access. I don't have a crystal ball, but the types of approaches for robotics will continue to increase dramatically,.It is an incredibly exciting time.
There is unlimited potential for the application of robotics in head and neck surgery, said Dr. O'Malley. He predicted that 80% of the range of types of ENT surgeries will be performed with some aspects of robotics within the next 25 years, including head and neck, ear, sinus, certain cosmetic and skull-based procedures.

Thank you,
Emeritus Prof. & Head
KEM Hospital


Thursday, 15 August 2013





Current role of transtympanic gentamicin therapy in the management of unilateral meniere’s disease is discussed in detail with its efficacy in  the management.
Transtympanic low dose gentamicin infusion is an alternative to surgical labyrinthectomy and Vestibular nerve section for the treatment of refractory vertigo associated with Meniere’s Gentamicin, the current drug of choice provides excellent vertigo control and is a less Invasive method to destroy the vestibular labyrinth. The goal of the treatment is to eliminate the abnormal vestibular inputs from the vestibular inputs from the diseased ear without adversely affecting the hearing. It’s salutary effect results from the damage of both the sensory neuroepithelium and the dark cells of the labyrinth. Intratympanic low dose gentamicin may cause sensory neural hearing loss hearing loss in some patients {10–15%}. Despite this S.N.. loss, results are encouraging. 50 cases of unilateral Meniere’s disease were treated at KEM hospital, Pune, during 1996 to 2012 with the follow–up of 2 to 4 yrs. All cases were infused with low dose gentamicin transtympanically for 4 to 6 weeks. This prospective study of gentamicin infusion revealed high success rate of controlling vertigo in about 92% patients. This treatment modality offers a less invasive but effective option for treating refractory vertigo of Meniere’s disease.We strongly recommend this modality of treatment for treating Mniere’s disease.

Low dose -- our preference
The low dose method involves using 1-2 injections of gentamicin, waiting a month between injections. This variant stops vertigo 70-80% of the time, with no significant side effects at all. The low dose variant is relatively new, and there is not nearly as much data concerning outcome as the high-dose variant.
The 2nd injection is given only if there has been a vertigo spell in the 2 weeks prior. In other words, instead of titrating to the onset of damage to vestibular system (as is done for high-dose ITG/TTG), the criterion is a good effect on the disease. This simple idea seems to result in far better results. Occasionally a 3rd dose is given. Usually this results in complete vestibular loss

Key words: Gentamicin, Meniere’s, chemical labyrinthectomy, micro wick

Meniere’s disease is a clinical disorder characterized by acute episodes of vertigo, fluctuating hearing loss, aural fullness & tinnitus2. 80% patients of Meniere’s disease are treated successfully by medical treatment. Remaining 20% who have failed medical treatment need either surgical or chemical ablation of vestibular function. Surgical procedures designed to prevent endolymphatic hydrops such as cochleostomy, endolymphatic sac shunt are falling out of favour due to high incidence of sensorineural hearing loss (20–30%). Vestibular nerve section, although very effective is a difficult surgery with significant morbidity and not uncommon complications

Schucknecht (1957) introduced transtympanic mode of delivery with streptomycin4 & Beck Schmidt (1978) first used gentamicin by the Transtympamnic route5 for treating Meniere’s disease and proved the efficacy of the gentamycin infusion. The success rate was 92–100%2,4,5,6. This prospective study of 50 patients of unilateral Meniere’s disease in KEM hospital, Pune, during 1996–2012 revealed that intratympanic gentamicin therapy has a success rate of controlling vertigo in 92% with S. N. loss in 10% of the cases. This being a safe, less invasive and readily accepted treatment modality was the choice of treatment in controlling refractory vertigo of Meniere’s disease. The intratympanic low dose gentamicin infusion (40mg/ml) buffered with 7.5% sodium bicarbonate solution was used slowly over a 10 minutes period. We have recorded our observations and post infusion results for over sixteen years and found that gentamicin therapy is an ideal option to surgical labyrinthectomy. The ease with which gentamicin can be obtained and apparently lower incidence of its cochleotoxic side–effect has currently made it the preferred aminoglycoside for chemical treatment of Meniere’s disease.

Materials & methods:
50cases of 32 males & 18 females within age group of 30–70 years of proved unilateral Meniere’s disease were treated with repeated transtympanic gentamicin infusion through the grommet for 4–6 weeks on weekly basis. During the study, we have excluded CSOM., acoustic neuroma, acoustic trauma, barotraumas, diabetes, hypertension, cervical spondylosis & anaemia with the relevant investigations. Only unilateral Meniere’s disease cases were included in the study group. Prior to infusion, all patients were subjected to routine investigation such as PT Audiometry, Tone decay, SISI, caloric tests, MRI. brain especially for internal auditory meatus and posterior cranial fossa and all relevant biochemical tests. All 50 cases were given medical treatment for at least 3 months prior to gentamicin infusion therapy. The treatment includes diuretics, vasodilators, labyrinthine sedatives, antiallergics and steroids.

All cases were also informed about the side effects of this treatment such as sensorineural hearing loss in 10%, ataxia lasting for 4–6 weeks and imbalance until central compensatory mechanisms take over and the need for the head and neck Catwhorne Cooksey’s exercises after the treatment end–point. The infusion of low dose gentamicin 40 mg/ml was used with dilution with 7.5% sodium bicarbonate solution. 10mg/ml gentamicin was slowly infused intratympanically by poster inferior quadrant myringotomy through grommet .

The study ear was elevated by 45 degrees and infusion continued slowly over 10 minutes. The patient maintained the supine position with the study ear above for about 45 minutes post–infusion in the recovery room. The infusions were administered on weekly basis for 4–6 wks. Depending on clinical response in controlling vertigo. The end point of the treatment was total relief from vertigo and associated symptoms. The morbidity of unsteadiness/dysequilibrium, S.N. loss and the appearance of spontaneous nystagmus were cardinal signs of the efficacy of the gentamicin infusion.

Table I: Age distribution:
Age group (years) No. of cases
Total 06

Table II – The sex ratio:
Sex No. of cases
Total 32

Table III – Transtympanic infusions required:
No. of Infusions Cases
Total 10

The results (As per guidelines of AAO–HNS, 1985) 7:
Table IV: Vertigo Relief (n=50)
Vertigo control No. of patients Percentage
Complete 36 72
Substantial 10 20
Limited 02 04
Insignificant 02 04
Worse 00 00

Table V: Hearing loss (n=50)
Hearing loss No. of patients Percentage
Worsened 05 10
Unchanged 37 74
Improved 08 16

Table VI : Tinnitus control (n=50)
Tinnitus control No. of patients Percentage
Absent 09 18
Improved 36 72
Unchanged 05 10

Table VII: Aural Fullness Control (n=50)
Aural Fullness Control No. of patients Percentage
Absent 31 62
Improved 19 38
Unchanged 00 00

Table VIII : Post Treatment  Caloric Response

Post Treatment Caloric Response          No. of patients Percentage
No. response                36         72
Poor response                10         20
No. Change                04         08

Table IX: Comparison of Results of various Authors.

          Authors        Vertigo Control       Hearing Loss
Beck & Schmidt (1978)5                95%              15%
Odkivist (1988) 8                95%              22%
Nedzelski (1993) 9               100%              37%
Lorne (1993) 10               100%              41%
Susanne & Pyykko (1995) 11                90%              32%
KEM Hospital Pune, Study (KKD)                92%              15%

It was observed that 4–6 wks period was taken to achieve excellent vertigo control. Post infusion audio vestibular tests were done in all cases to record the observations and results.

Results: (Table–IV, V, VI, VII, VIII)

During study, we have recorded complete control in 36 cases (72%), limited in 2 cases (4%) and insignificant in 2 cases (4%). The hearing loss worsened in 5 cases (10%), improved in 37 cases (74%) & not improved in 6 cases (18%). The tinnitus was absent in 9 cases (18%), improved in 36 cases (72%), and unchanged in 5 cases (10%). The aural fullness was absent in 31 cases (62%), improved in 19 cases (38%) and unchanged in 0 cases (0%).

Discussion: (Table IX)

One of the exciting new developments in inner ear research is the feasibility to place medications directly into the inner ear. Transtympanic low dose gentamicin infusion can be done by several methods such as transtympanic injection13, Micro Wick of Silverstien1, Microcatheter4, myringotomy & grommet, etc. the gentamicin is the current amino glycoside of choice because it is less cochleotoxic than streptomycin3 (John Shea, 1994) 13. Gentamicin has its ototoxic effect on the sensory neuroepithelium and it destroys the endolymph secreting cells (dark cells of utricle, base of ampullae & lateral wall of crus communes) 14.

We have chosen the myringotomy & grommet route for its simplicity and the repeated procedures required during the treatment. Since this is an office procedure, can be repeated on weekly basis, easily accepted by all the patients and is noninvasive and cost effective, this mode of drug delivery appeared to be the best to us.

Review of the literature revealed that results obtained in vertigo control and hearing loss are variable. Beck & Schmidt (1978) 5, had vertigo control was 95% and S. N. hearing loss was 15%. Odkivist (1988)8, had 95% vertigo control and 22% S. N. loss, Nedzelski (1992)9, had 100% vertigo control and 37% S.N. loss. Lorne (1993) 10 also had 100% vertigo control and 47% S. N.Loss. Susanne and Pyykko (1995)11 showed 90% vertigo control and 32% S.N. loss. Our study revealed 92% vertigo control and 15% S.N.loss.

From the study it appears that there are some disadvantages for gentamicin therapy such as 10% risk of hearing loss. Tinnitus and aural fullness may persist, and it is also difficult to regulate the actual degree of diffusion into perilymph bypassing the cohlea. It was also noted that there are various factors altering absorption of gentamicin in the inner ear like the thickness of round window membrane, scarring and adhesions in middle ear, head position and dependency or round window, potency of eustatian tube, rate of turnover of perilymph and endolymph and individual susceptibility to ototoxic gentamicin3.

The concentration of intratympanic gentamicin is most important in predicting the degree of ototoxicity while the duration of therapy appears to be less significant15. The optimal treatment regimen for Meniere’s disease will be such that vestibular hypo activity will be achieved but there will be no hearing loss.

It was also observed during the study that the no response to gentamicin infusion is probably be due to be central lesion e.g. migraine, micro vascular compression or it may be a bilateral Meniere’s disease or it could be due to the round window adhesions (which prevents proper passage of the drug delivery  to the inner ear) or other causes of vertigo. Due respect must be given to the accurate diagnosis of the Meniere’s disease and until one is very very sure about the diagnosis, one should not try this treatment. The other modality of treatment is nonchemical ablation of the vestibular endorgan by ultrasonic and cryosurgery which is not easily available at all the centeres2.

In our study all cases were administered medical treatment for 3 months before the transtympanic infusion. The follow–up was kept on regular basis at 3 months, 6 months, and yearly after the completion of the treatment. It was our observation that six patients (12%) developed irritative nystagmus following transtympanic gentamicin perfusion during the treatment, which recovered in 2 weeks time. This unique new finding may represent a recovery phenomenon resulting from a temporarily reversible ototoxic effect in the treatment ear. Despite small percentage of S. N. loss (10%) the results are encouraging with gentamicin infusion treatment


Author’s Conclusion:

Interest has been growing in the intratympanic application of medicine for the control of Meniere disease and other otologic maladies. Although the use of the aminoglycosides streptomycin and gentamicin has received the most attention, other medications, including dexamethasone and lidocaine, have also been given transtympanically. Despite the growing amount of research, many questions remain un ansered regarding the efficacy, safety, and dosing regimens of these treatments.
Optimal methods of inner ear drug delivery will depend on toxicity, therapeutic dose range, and characteristics of the agent to be delivered. Advanced therapy development will likely require direct intracochlear delivery with detailed understanding of associated pharmacokinetics.
Transtympanic  low dose gentamicin infusion has a consistent vertigo control (92%), is relatively inexpensive, easy to perform under local anesthesia as an office procedure and without significant morbidity. This chemical ablation provides a reasonably safe and effective method for controlling acute, recurrent vertigo in patients of Meniere’s disease who have failed medical therapy.
Intratympanic therapies offer an advantage over endolymphatic sac or destructive surgeries in that injections can be repeated with minimal costs and morbidity, and may be titrated to clinical response.

We strongly recommend this modality of treatment for severe, unilateral, refractory intractable vertigo of Meniere’s disease before destructive surgery is contemplated because long–term success with this procedure is significantly greater than with sac surgery or vestibular neurectomy.

Silverstein H. (1999) : Use of a new device, the Micro Wick (tm) to deliver medication to the inner ear. ENT Journal 79:8.
Scott Brown’s Otolaryngology, 6th Edition (1997): Butterworth & Heinemann Publication, Meniere’s Disease, 3:19:1–3:19:38.
Otolaryngologica Clinics of North America, Hirsh B. E., Kamerer D. B. (Dec. 1997): Role of chemical labyrinthectomy in the treatment of Meniere’s disease, Vol. 30, No. 6, 1039–1049.
Schuknecht H. F. (Dec.1997) : Ablation therapy in the management of Meniere’s disease. Acta Otolaryngology supplement (Stockh), 13:1–41.
Beck C., Schmidt C. L., (1978) : Ten years of experience with intratympanically applied streptomycin (Gentamicin) in the therapy of morbus Meniere, Archives Otolaryngology 221:149–152.
Surgery of the ear, Shambaugh, Glasscock, 4th Edition. W. B. Sounder’s Publication, Surgical treatment of periferal vestibular disorders, 467–500.
Pearson B. W., Brackmann D. E. (Chairman) (1985): Committee on hearing and equilibrium guidelines for repeating treatment results in Meniere’s disease. Otolaryngology Head and Neck Surgery, 13:579–581.
Odkvist L. M. (1988): Middle ear ototoxic treatment for Meniere’s disease. ACT Otolaryngology (Stockh) supplement 457:83–86.
Nedzelski J. M., Bryle G. E., Pfleiderer A. G.(1993): Treatment of Meniere’s disease: Update of an ongoing study. American Journal of Otolaryngology 14:278–282.
Lorne S. Parnes, Duncan Riddel, (1993): Irritative spontaneous nystagmus following intratympanic gentamicin for Meniere’s disease, Laryngoscope 103:745–759.
Susanna K., Pyykko I., Ishizaki H. & Aalto H., (1995): Effect of intratympanically administeree gentamicin on hearing & tinnitus in Meniere’s disease. Acta Otolaryngology (Stockh) supplement, 520:184–185.
Hirsch B. E., Kamerer D. B. (1997): Intratympanic Gentamicin in Meniere’s disease. American Journal of otolaryngology, 18:44–51.
John Shea Jr. & Xianxi G. E. (April 1994): Streptomycin perfusion of the labyrinth through the round window plus intravenous streptomycin, Otolaryngologc clinics of North America 78:542–561.
Kimura R. S. (1979): Distribution structure & function of dark cells in vestibular labyrinth American journal of Otolaryngology 78:542–561.
Mangnuson M., Paloan S. (1991): Delayed onset of ototoxic effects of gentamicin in the treatment of Meniere’s effects of gentamicin in the treatment of Meniere’s disease, Acta otolaryngology (Stockh) 111:671.
Address for correspondence
Dr. K. K. Desarda
Benali, Karve Road, Nal Stop,
Pune 411 004, Maharashtra, India.

Contributed by Dr. K. K. Desarda



Desarda K. K.a Dr. Nilima. Kharade,Dr.Sheetal (ENT Residents)
Professor and head department of ORL, KEM hospital, Pune.
Chief residents department of ORL, KEM hospital.
This paper was read at AOI conference, Cochin, January 2000.

Prof.Emeritus & Head Otolaryngology,
KEM Hospital, Pune


Cartilage has become an alternative to more traditional grafting materials for the tympanic membrane reconstruction.  Vein graft was very popular for many years, but has been replaced by temporalis fascia.  Perichondrium and dura matter have also being used.  Currently temporalis fascia and perichondrium are most commonly materials used. Cartilage has shown itself to be a novel material with high success rate in more challenging cases such as retraction pockets, recurrent perforation, atelectasis, cholesteatoma and ossicular chain reconstruction

To date, temporalis fascia and perichondrium remain the most commonly employed materials for closure of tympanic membrane perforations.  The success rate in TM reconstruction with these materials approaches 90%. In certain situations, such as the atelectatic ear, cholesteatoma, and revision tympanoplasty, the results with these materials have not been as gratifying.  Fascia and perichondrium have been shown to undergo atrophy and subsequent failure in the postoperative period.  This has led to the use of cartilage, which is a less compliant, more rigid material that resists resorption and retraction.  It has also been shown by different studies that it is well tolerated by the middle ear and hearing results have been comparable with those of fascia and perichondrium

The study presents six hundred ear operations of varied middle ear pathology using tragal cartilage and perichondrium as a choice graft. The technical advantages of tragal perichondrium graft in myringoplasty, ossiculoplasty, ossiousplasty, and mastoid cavity obliteration are discussed.

KEM Hospital Pune.

The study was conducted at K.E.M. Hospital, ENT department during 1980 to 2000. we have recorded our observations and results and concluded that tragal perichondrium and cartilage is an ideal graft material for reconstructive tympanoplasty. The objective of study was to assess the efficacy of tragal perichondrium and cartilage, the functional capacity in restoring hearing acuity, it’s mechanical survival, it’s extrusion rate and it’s functional integrity in tympanomastoid reconstruction.

Keywords: Cartilage, Perichondrium, Sialastic.



The technique of ‘Reconstructive Tympanoplasty’ has been improved and refined ever since the introduction of operative microscope. The methods of radical and modified radical mastoid operations have not changed for decades except for minor variations. The innumerable graft materials being used to restore the dry and functioning ear. The autologous, homologous and allograft, synthetic materials lik plastics, ceramics, hydroxyapatite and golds were used but none of these have established their universal acceptability as a proved graft except the autologous grafts (cartilage, ossicles, fascia). The functioning and survival of each graft material varies as each one has certain advantages ad disadvantages and technical problems during and after surgery.
Cartilage has become an alternative to more traditional grafting materials for the tympanic membrane reconstruction.  Vein graft was very popular for many years, but has been replaced by temporalis fascia.  Perichondrium and dura matter have also being used.  Currently temporalis fascia and perichondrium are most commonly materials used. Cartilage has shown itself to be a novel material with high success rate in more challenging cases such as retraction pockets, recurrent perforation, atelectasis, cholesteatoma and ossicular chain reconstruction.

To date, temporalis fascia and perichondrium remain the most commonly employed materials for closure of tympanic membrane perforations.  The success rate in TM reconstruction with these materials approaches 90%. In certain situations, such as the atelectatic ear, cholesteatoma, and revision tympanoplasty, the results with these materials have not been as gratifying.  Fascia and perichondrium have been shown to undergo atrophy and subsequent failure in the postoperative period.  This has led to the use of cartilage, which is a less compliant, more rigid material that resists resorption and retraction.  It has also been shown by different studies that it is well tolerated by the middle ear and hearing results have been comparable with those of fascia and perichondrium

 We present our experince of twenty years (1980–2000) in using ‘Tragal Cartilage and Perichondrium’ in the reconstructive tympanoplasty. This study includes 600 cases of varied middle ear pathologies grouped in to four main divisions such as myringoplasty, ossiculoplasty, ossiousplasty (for defects in attic, posterosuperior quadrant, posterior canal wall and annular defects) and cavity obliterations. This study is not a comparative study to prove the superiority of any particular graft material over another.

Principles of Cartilage Tympanoplasty

This study includes 600 cases of varied middle ear pathologies of both safe and unsafe C.S.O.M. All cases were treated conservatively for prolonged time before being subjected for reconstruction. The special attention was paid to Eustachian tube function. The relevant investigations as routine otomicroscopy, mastoid X–rays, paranasal sinus X–rays, audiometries and blood biochemistry were done.

Study Design: 600 Cases

The study was designed in four groups. Group A – Myringoplasty (n=300), Group B–Ossiculoplasty (n=110), Group C – Ossiculoplasty (n=120), and Group D – Mastoid cavity obliteration (n=70) All cases were subjected for reconstruction after eradicating the middle ear pathology by various surgical approaches. The enomeatal (n=192), endaural (n=312), postaural (n=60) and transtympanic (n=36). The age group was 15 to 55 years and males were predominant. Most of these cases were done under local anaesthesia with sedation (n=480) and smaller group under general anaesthesia (n=120).

During the study it was observed that the middle ear showed different pathologies such as perforations (n=240), adhesive otitis media (n=24), tympanosclerosis (n=36) and cholesteatomas (n=120). Statistical Analysis was done in SPSS 10.0 using chi–square test.


Group A - Myringoplasty (n=300):

Out of 300 cases onlay grafting was done in 172 cases and inlay grafting was done in 128 cases. The tragal perichondrium and catilage was the choice graft used with excellent post of results. The success rate was 96% and failures 4% in this group. The hearing gain with SRT was achieved within 15 dB AB gap closure. The failure of 4% were subjected to revision surgery. The dry and healed middle ear was seen within three months time. The failure cases were attributed to infection, unhygienic conditions,prosthesis displacement, graft rejection and  poor follow–ups. In this group the follow up was 2 to 6 yrs. Audiometric thresholds revealed 15–20 dB A–B gap closure. The follow up was achieved in 50% of cases for 2 to 4 years.

Group B– Ossiculoplasty (n=110) (Fig.1–6):

In this group all cases were subjected for tympanomastoidectomy with ossicular reconstruction by tragal cartilage and perichondrium struts of various types as L–shape, Bow–shape and Boomrang strut. Various combinations of Incudo–stapedial assembly, malleo–stapes strut, malleo–footplate assemblies were done. In all cases sialistic sheet was used so also the anterior canal skin as covering the graft assembly. In this group the success rate was 84% and failure rate was 16%. The failures were due to infection, prosthesis displacements and extrusion of the graft. Audiometric thresholds revealed 15–20 dB A–B gap closure. The follow up was achieved in 50% of cases for 2 to 4 years.

The technique used for cartilage reconstruction with ossiculoplasty depends on the presence or absence of the malleus manubrium. In the malleus present situation, the palisade technique is very effective and also provides good acoustic benefit. The malleus-absent situation represents one of the most challenging situations for cartilage tympanoplasty and ossicular reconstruction. The perichondrium/cartilage island flap is used in these cases to prevent the prosthesis touching the tympanic graft and preventing extrusion. In these cases, the anterior portion of the cartilage is held securely in place while the posterior half is folded out to expose the trailing edge of the anterior piece of cartilage, which acts, in effect, as a neo-malleus. The distance between the stapes footplate or suprastructure and this trailing edge is measured and the prosthesis is cut to the appropriate length. The posterior portion is unfolded.  The nice thing about folding the prosthesis in half is that you can visualize the prosthesis and have precise placement.

  Different ossicular defects and their correction by cartilage struts.

Group C– Osseusplasty (attic, PSQ, PCW, annular defects) (n=70):


Attic,marginal,post.superior quadrants defects(cholesteatoma)

Cholesteatoma represents one of the most controversial but important pathologic conditions in which cartilage is used. The primary purpose of cholesteatoma surgery is to eradicate disease and provide a safe, hearing ear. The magnitude of the controversy regarding optimal surgical care is beyond the scope of this presentation, but cartilage should arguably be involved in each technique. The palisade technique has been very useful in the cholesteatoma setting as it gives the opportunity, if needed, to perform an ossiculoplasty in a precise way. Also, some authors prefer to leave the anterior portion of the TM without cartilage for surveillance and possible tube placement, if necessary, in the postoperative period. However, cartilage placement in the posterior aspect of the TM can certainly delay a recurrence. but, in most series, cholesteatoma will recur in the anterior portion of the TM and it can be suspected in the setting of a recurrence in conductive hearing loss. After my review of literature, I found that the recurrence rate for cholesteatoma after cartilage tympanoplasty is less than 10%.  And if we compare this rate with cholesteatoma recurrence rate overall in children, we can appreciate that is much lower than rates previously reported in the literature which ranges from 10-46%

In this group the various defects of attic, posterosuperior quaderants, posterior canal wall and annular defects were closed by tragal perichondrium and cartilage grafts. The composite graft proved to be the best than nonbiological grafts in takeup and restoring dry ears. The cholesteatoma from the defect was removed and the defect was closed with the grafts. The posterior canal wall defect was reconstructed with the tragal cartilage graft and lined by perichondrum and anterior canal wall skin. This group achieved 75% success rate and 25% were failures which needed revision surgery.

Group D– Mastoid obliterations (n=120):

Mastoid obliterations

All mastoid cavities were preoperatively treated by suction clearance, dry mopping with antifungal and antibiotic drops for about 4–6 weeks. The cavities were fashioned by smooth drilling and removing all debris, pockets of cholesteatomas etc. the tragal cartilage was arranged in the palisade manner with the perichondrium coverage and the pedicled temporalis muscle was swinged to obliterate the mastoid cavities for good healing. Periodical follow up and aural toilet were done. The cavities re–epithelised well and achieved 70% success rate. 30% failures was because of infection and poor post op. follow ups. The modified radical mastoidectomy cavities were transformed into radical cavities to achieve good healing. The problems of mastoid cavities are still unresolved despite the treatment of various modified techniques being weak.

Table I – Age group in the study:
Age group (years) No. of cases Percent
15–25 168 28
25–35 264 44
35–45 120 20
45–55 48 08
Total 600 100

Table II: Sex distribution:
Age group (years) Male (no.) Female (no.) Total
15–25 108 60 168
25–35 120 144 264
35–45 72 42 120
45–55 24 24 48
Total 324 276 600
Percent 54 46 100

Table III – Surgical approaches:
Approaches No. of cases Percent
Endaural 312 52
Endomeatal 192 32
Postaural 60 10
Transtympanic 36 06
Total 600 100

Table IV – Anaesthesia:
Anaesthesia No. of cases Percent
General 120 20
Local + Sedation 480 80
Total 600 100

Table V – Pathological defects:
Type of Pathology No. of Cases %
Performation 240 40
Adhesive Otitis media 24 04
Tympanosclerosis 36 06
Retration pocket 180 30
Cholesteatoma 120 20
Total 600 100


Cartilage has become an alternative to more traditional grafting materials for the tympanic membrane reconstruction.  Vein graft was very popular for many years, but has been replaced by temporalis fascia.  Perichondrium and dura matter have also being used.  Currently temporalis fascia and perichondrium are most commonly materials used. Cartilage has shown itself to be a novel material with high success rate in more challenging cases such as retraction pockets, recurrent perforation, atelectasis, cholesteatoma and ossicular chain reconstruction


For many years the so called conservative methods of radical mastoid operations (Barany, Bondy, Citelli, Heerman, Stacke) were done in the clearance of disease but none of these proved better. At later dates Farrior, House, Lempert, Morrison added some minor variations in the technique of reconstructive tympanoplasty but still could not achieve the good results because the recurrence of the disease was very high. To modify these Victor Goodhill, Heerman and Heerman demonstrated their new techniques which prevented the recurrence of the cholesteatoma and gained the high success rates.

Distinct Advantages of Tragal Cartilage Graft

In this study 600 ear operations were performed with tragal perichondrium and cartilage as a composite graft in various types of middle ear reconstructions such as myringoplasty, ossiculoplsty, osseous reconstructions and mastoid obliterations. This study was done at K.E.M. Hospital E.N.T. department, Pune during 1980–2000. We have presented our observations of this reconstructive study of 20 years and found that the tragal cartilage is an ideal graft for the reconstructive middle ear surgery.

In the simple myringoplasty group the tragal perichondrium and cartilage achieved 96% success rate, the small, large and subtotal central perforations healed well in six weeks time. The inlay and onlay methods were used in the neotympanic reconstruction. In the total perforations and missing annulus the perichondrium angle was appropriate fit in forming the new annulus the perichondrium angle was appropriate fit in forming the new annulus. By this technique the blunting and lateralisation of the graft was prevented from the various cartilage assemblies in ossicular reconstruction achieved excellent stability and contact to bridge the gap in transformer mechanism. The incudostapedial gap was restored by cartilage sturt and maintained assembly. The malleostapedial, malleofootplate assembly proved good in restoring hearing.

Ideal Graft

In TORP. & PORP ossicular graft the interposed tragal cartilage and drum have increased the ossicular stability and improved hearing to 75% (Victor Goodhill). Chronic endotympanic depression is a pathological entity which leads to atelectasis, retraction pockets and cholestestoma formation. The tragal cartilage and perichondrium composite graft intervention has prevented the recurrence of the cholesteatoma pocket adhesions and tympanosclerosis. The postop results were dryhealed middle ears with good hearing.

Results of Cartilage Tympanoplasty

During the study it was observed that middle ear patology of 40% perforaytions of safe and unsafe types, 4% adhesive otitis media, 6% tympaosclerosis, 30% retraction pockets and 20% cholesteatoma sacs. All these pathologies were corrected by radical removal and tragal cartilage reconstruction.

In mastoid obliteration the palisade cartilageplasty proved in gaining dry cavities in 70% of the cases. The Eustachian tubal obstruction was relieved by tunnelplasty and improved the good middle ear aeration. The cartilage bridge over promontory and hypotympanum assures the proper contact with stapes and in the combined approach tymparoplasty procedure the recurrence of cholesteatoma in the sinus tympani and facial recess could be prevented by incorporating the composite tragal cartilage and perichondrium. In open cavities the tympanocartige stapedopexy improved the hearing. It was our observation that biological material like tragal cartilage, perichondrium, facia or ossicles etc. are much better than nonbiological materials in reconstructive surgery.

Poor Results in Cartilageplasty

The survival rate of tgragal graft material is much better than nonbiological materials.

The extrusion rate of cartilage is very minimal as compared to the other graft materials. The review of literature revealed the different extrusion rates of different materials, such as autologous, 1.19%, isografts 3.06% the synthetics 5.04%, human dentine 7.14%, gold prosthesis 8.7%. Overall the tragal cartilage and perichondrium proved to be the best graft materials in reconstructive tympanoplasty which is universally accepted.

Table VIII :Extrusion rates of commonly used graft materials:
Graft material Extrusion rate (%)
Autograft 1.19
Isograft 3.06
Synthetic 5.04
Human Dentine 7.14
Gold prosthesis 8.70

Table IX :Results of cartilage tympanoplasty: P=0.0001 by chi square:
Group Success (%) Failure (%)
Myringoplasty 96 04
Ossiculoplasty 84 16
Osseusplasty 75 25
Mastoid obliteration 70 30

Table X – Poor results in cartilageplasty:
Causes No. of cases
Displacement 12
Fibrosis 10
Absorption 06
Infection 08
Total 36

TABLE V – Pathological Defects:
Type of Pathology No. of Cases Percet
Performation 240 40
Adhesive Otitis media 24 04
Tympanosclerosis 36 06
Retration pocket 180 30
Cholesteatoma 120 20
Total 600 100

Table VI – Ossiculoplasty:
Lesion No. of cases Percent
Attic 55 50
Posterosuperior quadrant 33 30
Posterior canal wall 11 10
Eustachian tube 11 10
Total 110 100

Table VII – Ossicular Status (300 cases): –P=0.0001 by Chi square:
Structure Normal Eroded Destroyed
Maleus 120 72 108
Incus 000 96 204
Stapes 108 00 192


 The use of cartilage is experiencing a renaissance in ear surgery because it appears to offer an extremely reliable method for reconstruction of the tympanic membrane in cases of advanced middle ear pathology and Eustachian tube dysfunction.
Cartilage is particularly useful for the atelectatic ear, cholesteatoma, high risk perforation and for reinforcement of the tympanic membrane in conjunction with ossiculoplasty.
Hearing improvement can be experienced with the use of cartilage regarding the underlying pathology. Excellent clinical and experimental evidence exists to justify the use of cartilage as a grafting material in pediatric tympanoplasty. Cartilage tympanoplasty provides a tympanic membrane repair with greater structural stability and strength than traditional graft materials in many patients with challenging middle ear environments
In view of the above study we strongly recommend the tragal perichondrium and cartilage composite graft in various tympanoplasty reconstructions. The main reason being the cartilage is easily available at the site of operation, nontoxic, less, extrusion, minimum shrinkage, and lateralisation above all it is very cost effective to our patients. The hearing improvement within 15db of bone conduction has become almost a standard criterion for the analysis of surgical success.

Extrusion Rate of Commonly Used Graft Material


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Contributed by Dr. K. K. Desarda