To verify whether injection of substances into the endolymphatic sac (ES) diffuses into the endolymphatic compartments of the human inner ear and in particular to the endolymphatic space of the scala media (ESp-SM), as demonstrated in animals, an exploratory investigation with magnetic resonance imaging (MRI) and intraoperative electrocochleographic recordings (ECoG) was conducted in patients with Meniere's disease (MD) treated with ES decompression. A mixture of dexamethasone and gadolinium (GD) in solution was injected into the ES of 4 patients. The results of the ES injection procedure were compared with administration of the same solution intratympanically (IT, 1 patient) and via a platinotomy in 2 patients. The study was conducted retrospectively at a tertiary referral center. Main outcomes measures were pre- and postintervention complete audiological and neuro-otological evaluation; intraoperative ECoG investigation with evaluation of the morphology of acoustically elicited compound action potentials (CAPs) and 1.5 T MRI evaluations at different follow-up times. Distribution of GD from the ES injection procedure was observed first in the ES, after 24 h in the vestibule and semicircular canals, and after 24-48 h in the ESp-SM in all patients. High signal was detected within the inner ear for 1 week or more (mean: 10 days; range: 7-16 days). Changes in morphology and latency of CAPs were observed within 30 min of the dilatory injection into the ES in all patients. Administration of GD into the vestibule and the IT approach did not distribute the contrast in the ES and GD was observed in the perilymphatic space of the vestibule, cochlea and semicircular canals. No side effects relating to administration of GD into the ES, IT or into the vestibule were observed. To the best of our knowledge this is the first demonstration in humans that drugs injected into the endolymphatic structure of the ES diffuse to the cochlea, presumably into the ESp-SM. The possibility of injecting substances into the endolymphatic space might open up new prospects in the treatment of inner ear disorders. Further studies will be needed to define the limitations of this approach.
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