Release: September 9, 2001
Contact: Kenneth Satterfield (703) 519-1563 [email protected] 303-228-8460 (9/7-9/12)
LASER-ASSISTED MYRINGOTOMY FOUND TO BE EFFECTIVE FOR SHORT-TERM RELIEF OF ACUTE OTITIS MEDIA AND OTITIS MEDIA WITH EFFUSION
Researchers assert that OtoLAM is not as useful as traditional procedures ear infections that are recurrent or chronic.
Denver, CO -- Laser-assisted myringotomy with carbon-dioxide laser system (OtoLAM, ESC Medical Systems, Needham, MA) was introduced to physicians and patients in 1998 after clearance by the Food and Drug Administration two years before.
Essentially, the OtoLAM device creates a precise hole in the ear's tympanic membrane from 1-3 mm in diameter that can be adjusted in 0.1 mm increments. The CO2 laser delivery system, fiberoptic light source, and miniature video otoscope comprise an integrated unit that displays the procedure on a video screen. The procedure itself takes approximately one tenth of a second. The OtoLAM system provides unique visualization and control compared with other laser devices.
Since its introduction, this device has generated controversy regarding financial concerns, the lack of data to support its use, indications, and the uncertain role of short-term middle ear ventilation in treating middle ear disease. Those who support OtoLAM cite the ability to perform the procedure promptly in the office, avoidance of general anesthesia, and ventilation of several weeks duration?longer than myringotomy but much shorter than tympanostomy (the insertion of tubes). . The debate continues regarding the efficacy of OtoLAM. Researchers from several medical facilities in New York set out to evaluate the role of OtoLAM in the treatment of middle ear disease?specifically, acute otitis media (AOM), otitis media with effusion (OME), and eustachian tube dysfunction (ETD)?in the general population.
The authors of the study, "Otolam: the Real Story," are Alexa S. Lessow, MD, and Max M. April, MD, from the Department of Otolaryngology, New York University Medical Center; John P. Bent, MD, Assistant Professor, Department of Otolaryngology, Albert Einstein School of Medicine, New York Otolaryngology Institute; and Robert F. Ward, MD, Associate Professor, Department of Otolaryngology, Cornell University Medical Center, all from New York, NY. Their findings were presented on September 12, 2001, at the American Academy of Otolaryngology--Head and Neck Surgery Foundation Annual Meeting/OTO EXPO, being held September 9-12, 2001, at the Colorado Convention Center, Denver, CO.
Methodology: Ninety-five patients (123 ears) were prospectively enrolled between October 29, 1998 and July 3, 2000. The indications included recurrent acute otitis media (AOM), otitis media with effusion (OME), and eustachian tube dysfunction (ETD), all refractory to medical therapy. Informed consent was obtained, and all patients underwent OtoLAM in one or both ears for the treatment of AOM (45 patients), OME (39 patients), or ETD (11 eleven patients). The patient population age ranged from four months to 84 years. Topical tetracaine was applied to the eardrum prior to the procedure, and 66 patients (69 percent) also received ibuprofen or acetaminophen prior to or following the procedure. Laser energy spanned from eight to 25 watts, based on perceived tympanic membrane thickness, with a fenestration size ranging from 1.4 to 2.6 mm, based on desired length of ventilation. Patients were seen within one week for immediate follow-up, within four weeks for short-term follow-up, and then periodically from five weeks to two years as long-term follow-up.
Results: Of the 121 ears available for immediate follow-up, 59 ears (92 percent) diagnosed with AOM (n=59), 42 ears (98 percent) with OME, and 11 ears (79 percent) with ETD (n=11) had resolved middle ear disease following the procedure. Within one month, 39 or 75 percent of ears with AOM, 25 or 68 percent of ears with OME, and eight or 73 percent with ETD remained free of disease. Of the 95 ears available for long-term follow-up, 20 or 39 percent with AOM, 14 (42 percent) with OME, and five (45 percent) with ETD continued with no evidence of recurrent disease.
Four patients with AOM underwent repeat treatment with OtoLAM and eventually had bilateral myringotomy and tube placement. Two patients with OME had repeat laser myringotomies; one was lost to follow-up, and the second had a third laser treatment. Three patients with ETD had repeat procedures, one proceeding to a third, and two lost to follow-up. Thirty-eight percent of patients with AOM, 21 percent with OME, and 18 percent with ETD ultimately underwent bilateral myringotomy with tube placement in the operating room secondary to recurrent disease and symptoms.
The three cases of conductive hearing loss from large perforations all resolved once the laser myringotomies closed. There were no residual tympanic membrane perforations.
Conclusions: The authors suggest that OtoLAM can be used as an alternative to bilateral myringotomy with tube placement for short-term relief of AOM, OME and ETD but is not as useful for recurrent AOM and chronic OME. They contend the office procedure is ideal for treating children because the surgeon can produce an accurate and consistent laser myringotomy even in a moving patient. Their experience indicated that the test patients experienced brief pain roughly equivalent to that associated with an intramuscular immunization. OtoLAM is bloodless, convenient, and avoids the risks of general anesthesia and the potential complications of having a foreign body in the ear for a prolonged period oˆ
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