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Menieres slides-050518

  1. 1. Treatment Controversies in Meniere’s Disease Shashidhar S. Reddy, MD, MPH Shawn D. Newlands, MD, PhD UTMB Otolaryngology Grand Rounds May 18, 2005
  2. 2. Outline <ul><li>History and Meniere’s </li></ul><ul><li>Definition of Meniere’s </li></ul><ul><li>Physiology, Pathophysiology of Meniere’s </li></ul><ul><li>Medical Management of Meniere’s </li></ul><ul><li>Meniet Device </li></ul><ul><li>Intratympanic Gentamicin </li></ul><ul><li>Endolymphatic Sac Surgery </li></ul><ul><li>Vestibular Nerve Section </li></ul><ul><li>Conclusions </li></ul>
  3. 3. History of Meniere’s <ul><li>1861 – Prosper Meniere describes classic symptoms and attributes to labyrinth </li></ul><ul><li>1871 – Knappin theorizes dilatation of membranous Labyrinth </li></ul><ul><li>1938 – Hallpike and Portman confirm endolymphatic hydrops via temporal bone histology </li></ul><ul><li>1995 – Latest revision of AAOHNS definition </li></ul>
  4. 4. Definition of Meniere’s Disease <ul><li>AAO-HNS Committee on Hearing and Equilibrium revised definition in 1995 </li></ul><ul><ul><li>Possible Meniere's disease </li></ul></ul><ul><ul><ul><li>Episodic vertigo of the Meniere's type without documented hearing loss, or </li></ul></ul></ul><ul><ul><ul><li>Sensorineural hearing loss, fluctuating or fixed, with dysequilibrium but without definitive episodes </li></ul></ul></ul><ul><ul><ul><li>Other causes excluded </li></ul></ul></ul><ul><ul><li>Probable Meniere's disease </li></ul></ul><ul><ul><ul><li>One definitive episode of vertigo </li></ul></ul></ul><ul><ul><ul><li>Audiometrically documented hearing loss on at least one occasion </li></ul></ul></ul><ul><ul><ul><li>Tinnitus or aural fullness in the treated ear </li></ul></ul></ul><ul><ul><ul><li>Other causes excluded  </li></ul></ul></ul><ul><ul><li>Definite Meniere's disease </li></ul></ul><ul><ul><ul><li>Two or more definitive spontaneous episodes of vertigo 20 minutes or longer </li></ul></ul></ul><ul><ul><ul><li>Audiometrically documented hearing loss on at least one occasion </li></ul></ul></ul><ul><ul><ul><li>Tinnitus or aural fullness in the treated ear </li></ul></ul></ul><ul><ul><ul><li>Other cases excluded  </li></ul></ul></ul><ul><ul><li>Certain Meniere's disease </li></ul></ul><ul><ul><ul><li>Definite Meniere's disease, plus histopathologic confirmation </li></ul></ul></ul>Committee on Hearing and Equilibrium Guidelines for Diagnoses and Evaluation of Therapy in Meniere’s Disease, AAOHNS Board of Directors March 1994
  5. 5. Definition of Meniere’s <ul><li>Staging of Hearing Loss in Definite/Certain Meniere’s: </li></ul>Committee on Hearing and Equilibrium Guidelines for Diagnoses and Evaluation of Therapy in Meniere’s Disease, AAOHNS Board of Directors March 1994 >70 4 41-70 3 26-40 2 <=25 1 Four Tone Average dB Stage
  6. 6. Definition of Meniere’s <ul><li>Functional Level Scale </li></ul><ul><ul><li>Regarding my current state of overall function, not just during attacks (check the ONE that best applies): </li></ul></ul><ul><ul><li>1. My dizziness has no effect on my activities at all. </li></ul></ul><ul><ul><li>2. When I am dizzy I have to stop what I am doing for a while, but it soon passes and I can resume activities. I continue to work, drive, and engage in any activity I choose without restriction. I have not changed any plans or activities to accommodate my dizziness. </li></ul></ul><ul><ul><li>3. When I am dizzy, I have to stop what I am doing for a while, but it does pass and I can resume activities. I continue to work, drive, and engage in most activities I choose, but I have had to change some plans and make some allowance for my dizziness. </li></ul></ul><ul><ul><li>4. I am able to work, drive, travel, take care of a family, or engage in most essential activities, but I must exert a great deal of effort to do so. I must constantly make adjustments in my activities and budge my energies. I am barely making it. </li></ul></ul><ul><ul><li>5. I am unable to work, drive, or take care of a family. I am unable to do most of the active things that I used to. Even essential activities must be limited. I am disabled. </li></ul></ul><ul><ul><li>6. I have been disabled for 1 year or longer and/or I receive compensation (money) because of my dizziness or balance problem. </li></ul></ul>Committee on Hearing and Equilibrium Guidelines for Diagnoses and Evaluation of Therapy in Meniere’s Disease, AAOHNS Board of Directors March 1994
  7. 7. Definition of Meniere’s <ul><li>Reporting Results of Treatment: </li></ul><ul><ul><li>Divide frequency of spells 18-24months by number 6months prior to tx and multiplyx100 </li></ul></ul>Committee on Hearing and Equilibrium Guidelines for Diagnoses and Evaluation of Therapy in Meniere’s Disease, AAOHNS Board of Directors March 1994 E >120 F Secondary Treatment D 81-120 C 41 to 80 B 1 to 40 A 0 Class Numerical Value
  8. 8. Physiology <ul><li>Perilymph – Similar in composition to CSF </li></ul><ul><ul><li>High Na+, Low K+ </li></ul></ul><ul><li>Endolymph – Similar in compostion to ICF </li></ul><ul><ul><li>Low Na+ High K+ </li></ul></ul><ul><ul><li>Believed to be produced in Stria Vascularis </li></ul></ul><ul><li>Membranous Labyrinth separates the two </li></ul><ul><ul><li>Difference of 80mV in charge </li></ul></ul><ul><ul><li>No difference in pressure </li></ul></ul>
  9. 9. Physiology <ul><li>Production and flow of Endolymph - Theories </li></ul><ul><ul><li>Longitudinal – produced in membranous labyrinth, flows to endolymphatic sac, then to dural venous sinuses </li></ul></ul><ul><ul><li>Diffuse – produced and absorbed along the membranous labyrinth </li></ul></ul><ul><ul><li>Periodic Flow – endolymph flows only with changes in volume or pressure </li></ul></ul>Andrews, JC, Intralabyrinthine fluid dynamics: Meniere disease 12(5) Oct 2004 pp408-412
  10. 10. Pathophysiology <ul><li>Endolymphatic hydrops leads to distortion of membranous labyrinth </li></ul>
  11. 11. Pathophysiology <ul><li>Build up in pressure may lead to micro-ruptures of membranous labyrinth (Minor et al ) </li></ul><ul><ul><li>Ruptures are confirmed by various histologic studies </li></ul></ul><ul><ul><li>May responsible for episodic nature of attacks </li></ul></ul><ul><ul><li>Healing of ruptures may account for return of hearing </li></ul></ul>Review Article: Minor, Lloyd et al , Meniere’s Disease, Current Opinion in Neurology 17(1) Feb2004
  12. 12. Pathophysiology <ul><li>What causes hydrops? </li></ul><ul><ul><li>Obstruction of endolymphatic duct/sac </li></ul></ul><ul><ul><ul><li>Obstruction of endolymphatic sac in does not cause hydrops in all animals and causes vertigo in few </li></ul></ul></ul><ul><ul><li>Alteration of absorption of endolymph </li></ul></ul><ul><ul><li>Immunologic insult to inner ear </li></ul></ul><ul><ul><ul><li>Elevated levels of IG’s in endolymph </li></ul></ul></ul>
  13. 13. Pathophysiology <ul><li>Hydrops role in causation of Meniere’s is not entirely clear </li></ul><ul><ul><li>Rauche et al 1998 – Study of 19 temporal bone histologies with hydrops- </li></ul></ul><ul><ul><ul><li>13/19 patients with hydrops by histology showed Meniere’s symptoms by chart review </li></ul></ul></ul><ul><ul><ul><li>6/19 showed no Meniere’s symptoms by chart review </li></ul></ul></ul>Rauch SD, et al Meniere’s syndrome and endolymphatic hydrops: double blind temporal bone study. Ann Otol Rhinol Laryngol 1989; 98:873-883
  14. 14. Pathophysiology <ul><li>Silverstein et al found that in pts. who refused surgical tx., there was resolution of vestibular symptoms </li></ul><ul><ul><li>57-60% of patients in 2 years </li></ul></ul><ul><ul><li>71% at eight years. </li></ul></ul><ul><ul><li>Long term PTA in affected ear is 50dB </li></ul></ul><ul><ul><li>Speech discrimination is 53% </li></ul></ul><ul><ul><li>Caloric response reduction is 50% </li></ul></ul>Silverstein H., Smouha E. & Jones R. (1989) Natural history vs surgery for Ménière's disease. Otolaryngol. Head Neck Surg. 100, 6-16
  15. 15. Medical Management <ul><li>Acute Therapy </li></ul><ul><li>Maintenance Therapy </li></ul>
  16. 16. Medical Management <ul><li>Acute Therapy </li></ul><ul><ul><li>Relatively non-controversial </li></ul></ul>Brookes, G.B. The pharmacological treatment of Meniere’s disease. Clinical Otolaryngology 21(1) Feb1996, pp3-11
  17. 17. Medical Management <ul><li>Maintenance Therapy </li></ul><ul><ul><li>No conclusive studies show efficacy of drugs intended to alter disease course of Meniere’s </li></ul></ul>
  18. 18. Medical Management <ul><li>Diuretics and Salt restriction </li></ul><ul><ul><li>? Alter fluid balance in inner ear leading to depletion of endolymph </li></ul></ul><ul><ul><li>Shinkawa/Kimura unable to demonstrate beneficial effect on hydrops in animal model </li></ul></ul>Shinkawa H. & Kimura R.S. (1986) Effect of diuretics on endolymphatic hydrops. Acta. Otolaryngol. (Stockh.)101, 43-52
  19. 19. Medical Management <ul><li>Diuretics and Salt Restriction </li></ul><ul><ul><li>Ruckenstein et al evaluated data from two double blind studies by Klockhoff and Lindblom on HCTZ vs. Placebo and showed no difference in Diuretics vs. placebo </li></ul></ul>Ruckenstein M.J., Rutka J.A. & Hawke M. (1991) The treatment of Meniere's disease: Torok revisited. Laryngoscope101, 211-218
  20. 20. Medical Management <ul><li>Osmotic Diuretics (Urea, Glycerol) </li></ul><ul><ul><li>Have been consistently shown to reduce symptoms in a proportion of patients, but the effects only last for a few hours </li></ul></ul><ul><ul><li>Objective data includes alteration of the SP:AP ratio on Electrocochleography </li></ul></ul><ul><li>Acetazolamide – was actually shown to increase hydrops and hearing loss when given IV and had no benefit p.o. </li></ul>
  21. 21. Medical Management <ul><li>Vasodilators </li></ul><ul><ul><li>Purported to work by decreasing ischemia in the inner ear and allowing better metabolism of endolymph </li></ul></ul><ul><ul><li>Betahistine is a popular choice, with several studies showing decreased vertigo with use </li></ul></ul><ul><ul><ul><li>Cochrane Database Review (2004) – Only one Grade B study and four Grade C studies, none of which produced convincing evidence for use. </li></ul></ul></ul>James, AL, et al . Betahistine for Meniere’s disease or syndrome. Cochrane Database of Systematic Reviews (2) 2005
  22. 22. Medical Management <ul><li>Immunologic Management </li></ul><ul><ul><li>Systemic steroids and intratympanic dexamethasone have been studied and showed no conclusive benefit. </li></ul></ul><ul><ul><li>Double-blinded prospective crossover study by Silverstein et al showed no difference from placebo with intratympanic dexamethasone injections </li></ul></ul>Silverstein, Herbert et al Dexamethasone inner ear perfusion for the treatment of meniere’s disease: a prospective, randomized, double-blind, crossover trial. American Journal of Otology. 1998. 19:196-201
  23. 23. Mechanical Management <ul><li>Transtympanic “Micropressure” Treatment </li></ul><ul><ul><li>Meniett Device (Xomed) – FDA approved in 1999 as a class II device </li></ul></ul><ul><ul><li>Advocates present no strong case for why the device should work </li></ul></ul><ul><ul><li>Portably, low intensity alternating pressure generator </li></ul></ul>
  24. 24. Mechanical Management <ul><li>Gates et al 2004 </li></ul><ul><ul><li>Prospective, randomized, placebo control trial of Meniett device </li></ul></ul>Gates GA. Green JD Jr. Tucci DL. Telian SA. The effects of transtympanic micropressure treatment in people with unilateral Meniere's disease. Archives of Otolaryngology -- Head & Neck Surgery. 130(6):718-25, 2004 Jun. Did not use standardized vertigo assesment Did not comment on severity of vertigo Did not give good data on objective testing
  25. 25. Intratympanic Therapy <ul><li>Goal is to maximize local effects in inner ear while minimizing systemic effects </li></ul><ul><li>Round window is point of diffusion to inner ear </li></ul><ul><li>Intratympanic dexamethasone already discussed </li></ul><ul><li>Aminoglycoside Antibiotics: affect hair cells of crista, ampulla, and cochlea </li></ul>
  26. 26. Intratympanic Therapy <ul><li>Fowler in 1948, and later Schuknecht established role of systemic streptomycin for bilateral disease (2gIVPB qd until vestibular symptoms were noted) </li></ul><ul><li>Hearing loss and oscillopsia were a problem with this therapy, though reducing dosage seemed to help </li></ul>
  27. 27. Intratympanic Gentamicin <ul><li>Preferred because of Gentamicin’s vestibuloselectivity </li></ul><ul><li>Side effects can include temporary imbalance or nystagmus </li></ul><ul><li>Hearing loss </li></ul><ul><li>Many methods of delivery exist </li></ul>
  28. 28. Intratympanic Gentamicin <ul><li>Titration Therapy </li></ul><ul><ul><li>Martin and Perez 2003 (prospective study, n=71) </li></ul></ul><ul><ul><ul><li>Serial daily injections of buffered (pH 6.4) 26.7mg/cc gentamicin solution via 27 gauge needle into middle ear </li></ul></ul></ul><ul><ul><ul><li>Injections repeated until vestibular symptoms developed (spontaneous or evoked nystagmus) </li></ul></ul></ul><ul><ul><ul><li>At 2 years, 69% had Class A vertigo control, 14.1% had Class B </li></ul></ul></ul><ul><ul><ul><li>32.4% had hearing loss </li></ul></ul></ul>Martin E, Perez N: Hearing loss after intratympanic gentamicin therapy for unilateral Meniere’s Disease. Otol Neurotol 2003, 24:800-806
  29. 29. Intratympanic Gentamicin <ul><li>Ablation via Multiple Daily Dosing </li></ul><ul><ul><li>Jackson and Silverstein – Study on 92 patients who underwent myringotomy and wick placement through to round window niche. </li></ul></ul><ul><ul><ul><li>Pts. self-administered gentamicin drops TID until 100% reduction on ENG of vestibular response </li></ul></ul></ul><ul><ul><ul><li>85% relief of vertigo, 67% improvement in aural pressure </li></ul></ul></ul><ul><ul><ul><li>36% hearing loss </li></ul></ul></ul>Jackson, LE; Silverstein, H: Chemical perfusion of the inner ear. Otolaryngol Clin North Am 2002, 35:639-653
  30. 30. Intratympanic Gentamicin <ul><li>Low dose therapy </li></ul><ul><ul><li>Harner et al 2001 – retrospective study of 51 patients who received 1 dose of 40mg/mL injection and were re-evaluated in 1 month and given another if needed </li></ul></ul><ul><ul><li>At 2 years, 86% had vertigo class A or B </li></ul></ul><ul><ul><li>He reported minimal change in PTA but drop in SRT’s </li></ul></ul><ul><ul><li>Claimed better hearing preservation with this </li></ul></ul>Harner, Stephen et al : Long-term follow-up of transtympanic gentamicin for Meniere’s Syndrome. Otology & Neurotol 22:210-214, 2001
  31. 31. Intratympanic Gentamicin <ul><li>Other methods of delivery </li></ul><ul><ul><li>Weekly administration </li></ul></ul><ul><ul><ul><li>Single dose of gentamicin once a week for four treatments </li></ul></ul></ul><ul><ul><li>Continuous administration </li></ul></ul><ul><ul><ul><li>Microcatheter delivery of gentamicin using a continuous perfusion method </li></ul></ul></ul><ul><ul><ul><li>Results in extremely variable amount of gentamicin delivery </li></ul></ul></ul><ul><ul><ul><li>Better perfusion techniques may be needed </li></ul></ul></ul>
  32. 32. Intratympanic Gentamicin <ul><li>Chia et al performed a meta-analysis of different modalities of application in 2004 </li></ul>Chia, Stanley H, et al Intratympanic Gentamicin Therapy for Meniere’s Disease: a Meta-Analysis. Otology&Neurotol 25(4) July 2004 pp 544-552 Class A or B Vertigo Control
  33. 33. Intratympanic Gentamicin <ul><li>Hearing loss was greatest for multiple daily dosing </li></ul><ul><li>Hearing loss was least for titration therapy </li></ul><ul><li>Hearing loss was not lower than average for low-dose therapy </li></ul>
  34. 34. Endolymphatic Sac Surgery <ul><li>Purported to address the site of obstruction causing hydrops </li></ul><ul><ul><li>4 types: </li></ul></ul><ul><ul><ul><li>Decompression – removal of bone around the sac </li></ul></ul></ul><ul><ul><ul><li>Shunting – placement of synthetic shunt to drain endolymph into mastoid </li></ul></ul></ul><ul><ul><ul><li>Drainage – incision of the sac to allow drainage </li></ul></ul></ul><ul><ul><ul><li>Removal of sac – to address the possibility that the sac may actually play a role in endolymph production </li></ul></ul></ul>
  35. 35. Endolymphatic Sac Surgery Coker, Newton J. et al Atlas of Otologic Surgery . W.B. Saunders 2001
  36. 36. Endolymphatic Sac Surgery <ul><li>Jens Thomsen et al 1981 </li></ul><ul><ul><li>Double-blinded placebo-control study with sham surgery (cortical mastoidectomy) vs endolymphatic shunt placement in 30 patients </li></ul></ul><ul><ul><li>No difference in any outcome between sham surgery and endolymphatic sac shunt group </li></ul></ul>Thomsen, Jen et al . Placebo Effect in Surgery for Meniere’s Disease. Arch Otolaryngol – Vol 107, May 1981, pp271-277
  37. 37. Vestibular Nerve Section <ul><li>Can achieve vestibular suppression without any effect on hearing </li></ul><ul><li>Single step procedure </li></ul><ul><li>Can have intraoperative complications of damage to facial nerve, cochlear nerve, or CSF leak (rate of CSF leak is about 13%) </li></ul><ul><li>Approaches: Middle Fossa, Retrolabyrinthine/Retrosigmoid </li></ul>
  38. 38. Vestibular Nerve Section Coker, Newton J. et al Atlas of Otologic Surgery . W.B. Saunders 2001
  39. 39. Vestibular Nerve Section <ul><li>Hillman et al 2004 retrospectively compared v. nerve section to intratymp. Gent. </li></ul><ul><ul><li>Performed via combined mastoidectomy/retrosig approach </li></ul></ul>Hillman, Todd A, et al. Vestibular Nerve Section Versus Intratympanic Gentamicin for Meniere’s Disease. Laryngoscope 114:pp 216-224
  40. 40. Vestibular Nerve Section <ul><li>Hillman et al continued </li></ul>
  41. 41. Vestibular Nerve Section <ul><li>Hillman et al continued </li></ul><ul><ul><li>No incidence of wound infection or meningitis in this group </li></ul></ul><ul><ul><li>12.6% incidence of CSF leak requiring LP and extended hospitalization </li></ul></ul><ul><ul><li>Rates of disequilibrium were similar but persisted longer in the nerve section group </li></ul></ul>
  42. 42. Other Ablative Surgeries <ul><li>Labyrinthectomy </li></ul><ul><ul><li>Useful in patients with no serviceable hearing and those who cannot tolerate intracranial procedure </li></ul></ul><ul><ul><li>Similar in efficacy to vestibular nerve section </li></ul></ul>
  43. 43. Conclusions <ul><li>Therapies that definitely reduce vertigo in Meniere’s Disease: </li></ul><ul><ul><li>Vestibular suppressant medications </li></ul></ul><ul><ul><li>Intratympanic Gentamicin (especially when titrated) </li></ul></ul><ul><ul><li>Vestibular Nerve Section </li></ul></ul><ul><ul><li>Labyrinthectomy </li></ul></ul><ul><li>Other therapies discussed are unproven or controversial </li></ul>