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Bianchin G, Russi G, Romano N, Fioravanti P.

Treatment with HELP-Apheresis in Patients Suffering from Sudden Sensorineural Hearing Loss: A Prospective, Randomized, Controlled Study. Bianchin G, Russi G, Romano N, Fioravanti P. Otorhinolaryngology Unit , Santa Maria Nuova Hospital, Reggio Emilia, Italy. Laryngoscope. 2010 Jan 26

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Bianchin G, Russi G, Romano N, Fioravanti P.

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  1. Treatment with HELP-Apheresis in Patients Suffering from Sudden Sensorineural Hearing Loss: A Prospective, Randomized, Controlled Study Bianchin G, Russi G, Romano N, Fioravanti P. Otorhinolaryngology Unit , Santa Maria Nuova Hospital, Reggio Emilia, Italy. Laryngoscope. 2010 Jan 26 Ri 何佾昌/ VS 吳振吉

  2. Objective SSHL withhigh LDL HELP-apheresis Standard treatment Standard treatment

  3. Introduction • Sudden sensorineural hearing loss (SSHL) • Mostly unilateral • NIDCD: idiopathic hearing loss of ≧30dB over ≧3 contiguous test frequencies occurring within 3 days • Etiology: • Viral infection? • Autoimmunologic mechanism? • Rupture of inner ear membrane? • Disturbance of cochlear microcirculation • Blood flow ↓ • Hyperviscosity: hypercholesteroleamia

  4. Introduction • HELP apheresis: heparin induced LDL and fibrinogen precipitation • Improve hemorheology in pt with sudden hearing loss Increased RBC adhesiveness/aggregation owing to fibrinogen elevation in hypercholesterolaemic patients and the rationale of fibrinogen-lowering by LDL apheresis. Eur J Clin Inv 2004;34:378-379 • Circulating adhesion molecules (E-selectin, VCAM-1, VCAM-1) reduced by apheresis Does a reduction of adhesion molecules by LDL-apheresis have a role in the treatment of sudden hearing loss? Ther Apher Dial 2006;10:282-286

  5. Introduction • LDL/fibrinogen apheresis v.s. standard treatment • ST: prednisolone, hydroxyethyl starch, pentixifylline • Outcome: PTA, speech audiometry, tinnitus, side effect • Result: NS but better in apheresis group, esp high LDL Fibrinogen and LDL apheresis in treatment of sudden hearing loss: a randomised multicentrerial. Lancet 2002;360:1811–1817

  6. Method • Pt selection • Hearing symmetry before SSHL • Inclusion: • Acute, one-side SSHL, ≦20 days before treatment • LDL > 120 mg/dL • Exclusion: • Hx of hearing loss, Meniere’s dz, dz of middle ear • Tumor, heart dz, dialyzed, coagulopathy, allergy to heparin, severe liver dz • Superiority study (difference ≧30%)

  7. Method • Standard treatment (ST) • Glycerol 500ml IF QD ×10D • Dexamethasone 8mg IM QD ×10D • HELP-apheresis • 0.55μm plasma filter • Mixed with 0.2M Na acetate buffer (pH 4.85) containing 100 IU/mL heparin • LDL and fibrinogen precipitates at pH 5.12 • 0.4μm polycarbonate filter • Anion exchange absorber (remove at least 300000 IU heparin) • Bicarbonate dialysis + ultrafiltration • 3L in 2hr, once

  8. Method • HELP-apheresis • TC -52%, LDL -56%, VLDL -52%, lipoprotein A -55%, TG -50% • Fibrinogen -56%, thrombin -55%, VWF -56%, FV -57%, FVII -35% • CRP -56%, plasma viscosity -14%, RBC aggregability -60%, thrombocyte aggregability -60% • HDL +14%, peripheral muscle oxygenation +33~50%, coronary flow reserve +14%, cerebral CO2 reactivity +14% Evidence for maximal treatment of atherosclerosis: drastic reduction of cholesterol and fibrinogen restores vascular homeostasis. Ther Apher 2001;5:207-211

  9. Method • Prospective, randomized • No placebo apheresis due to ethical reasons • Pt and investigators were not blinded • Audiologists were blinded

  10. Method • Acoustic measurement • [Pre]: admission day • [Post]: end of treatment • [Last]: 10 days after the end of treatment • Frequencies: 250, 500, 1k, 2k, 4k Hz • Outcome measurement • Recovery percentage (%) • Mean tonal threshold percentage (%) • Decibel recovery (dB)

  11. Results ST HELP-ST

  12. >30%! • More hearing recovery in HELP-ST group • “Subsided pressure sensation of affected ear after apheresis”.

  13. HELP-ST group: significant at both [post] and [last] for all frequencies • 250, 500, 1k Hz > 2k, 4k Hz • NS between [post] and [last].

  14. HELP-ST better than ST • More evident at [post] and 250, 500, 2k Hz.

  15. HELP-ST > ST.

  16. Higher in fibrinogen<320 • Better recovery in fibrinogen <320.

  17. HELP+ST as a choice for SSHL with fibrinogen>320.

  18. HELP-ST better than ST, both period >8 or <8 days.

  19. Discussion • Disturbance of cochlear microcirculation • Viremia → swelling of capillary endothelial cell & mild hypercoagulation • Increased viscosity → microcirculation↓ • Reduction of fibrinogen → viscosity↓ 20% Haemorheology in defined dyslipoproteinemias with elevated serum triglyceride concentrations. Atherosclerosis 1995;125:s117. • HELP: pronounced improvement in pt with high fibrinogen and LDL Fibrinogen and LDL apheresis in treatment of sudden hearing loss: a randomised multicentre trial. Lancet 2002;360:1811–1817.

  20. Discussion • Plasma viscosity • Inversely proportional to blood flow • Hct, serum viscosity, RBC aggregation, RBC deformability • Low shear stress • ↑Plt & macrophage adhesion, ↓NO, ↑plt & endothelial growth factor • Interaction between RBCs • Attraction: van der Waal force • Repulsion: negative charge on RBC membrance • Counteract by LDL (30nm), fibrinogen (47nm) • HDL (10nm): competition with LDL

  21. Discussion • HELP-apheresis: heparin for precipitation of LDL and fibrinogen but totally absorbed later→heparin not affect the outcome • Improvement > 30% • HELP-ST: 75% [post], 76.4% [last] • ST: 41.7% [post], 45% [last] • HELP-ST better than ST: • All frequencies • [post] or [last] • % value or dB value

  22. Discussion • HELP-ST better than ST • No report of adverse reaction or side effect • Nausea/vomiting • Allergy to heparin • Wound infection, bleeding • Pt: “I would receive apheresis again if hearing loss recurred” • No influence of fibrinogen on outcome Improved Treatment of Sudden Hearing Loss by Specific Fibrinogen Apheresis. J Clin Apheresis 2004;19: 71–78. • Good recovery in both <320 or >320 • Better in group of >320

  23. Conclusion • HELP-apheresis is safe and effective treatment for SSHL • Especially high LDL and/or fibrinogen • No complication • Pt’s QoL better (standardized SF36 questionnaire) Rheopheresis for idiopathic sudden hearing loss: results from a large prospective, multicenter, randomized, controlled clinical trial. Eur Arch Otorhinolaryngol 2009;266:943–953. • By studying this dz and its response to new therapeutic approaches, we are able to gain insight into pathophysiology of inner ear

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