The Laryngoscope Lippincott Williams & Wilkins, Inc.

, Philadelphia 2000 The American Laryngological, Rhinological and Otological Society, Inc.

MOSER AWARD

Laser-Assisted Endoscopic Stapedectomy: A Prospective Study

Dennis S. Poe, MD

Objective: To improve the techniques required to perform a stapedotomy without prosthesis (stapedioplasty). Study Design: New infrared lasers were evaluated for potential use in otological surgery in guinea pigs. A prospective human trial of 34 primary stapes operations using the Argon ion laser was performed, with 11 stapedioplasties and 23 conventional stapedotomies as controls. Methods: Lasertissue interactions were evaluated for temporal bone and live guinea pig tissues, measuring crater histology and labyrinthine temperature elevations. Patients undergoing stapedioplasty had Argon ion laser cuts with endoscopic assistance made in the anterior crus and footplate to mobilize the posterior segment of the stapes while the anterior portion remained fixed. Results: Diode laser (808-nm) vaporization craters and temperature elevations in the vestibule were suitable for clinical use. Overall, stapedioplasty patients hearing was improved with air-bone gap closure to a mean of 8.3 dB (SD 9.8 dB). Conclusions: Patients with anterior footplate otosclerosis are candidates for stapedioplasty preserving the annular ring and stapes tendon and eliminating prosthesis complications. High-resolution small endoscopes, coupled with Argon ion or diode lasers promise to improve stapes visualization, enhancing the ability to perform minimally invasive surgery on the stapes footplate. Key Words: Stapedectomy, laser, endoscopy. Laryngoscope, 110:137, 2000

INTRODUCTION
Surgery to improve hearing loss attributable to otospongiosis involving the stapes footplate (commonly referred to as otosclerosis) has had an unusual history al-

Presented as a Candidates Thesis to the American Laryngological, Rhinological and Otological Society, Inc. Recipient of the Harold P. Moser Excellence in Clinical Research Award. From the Department of Otolaryngology, Massachusetts Eye and Ear Infirmary; and the Department of Otology and Laryngology, Harvard Medical School, Boston, Massachusetts. This work was supported by a grant from the Deafness Research Foundation. EndoOptiks, Inc. kindly supported the cost of publication of this thesis. Send Correspondence to Dennis S. Poe, MD, Zero Emerson Place, Suite 2C, Boston, MA 02114, U.S.A.

ternating between total excision of the stapes and minimal mobilization procedures. Modern small fenestra stapedotomy procedures using the piston type of prostheses have enjoyed a long-standing record of excellent hearing results and minimal complications. There remain risks of complete deafness and vertigo complications. The most common reason for failure of stapedotomy or stapedectomy is a complication related to the prosthesis as reported by Silverstein,1 who noted that 63% of revision cases in that study demonstrated a prosthesis failure. Mobilization procedures in the past suffered from a high refixation rate, since the stapes was generally mobilized through the otosclerotic focus.2 Attempts were later made to perform stapedotomies fracturing through the normal footplate posterior to the otosclerotic focus in conjunction with a division of the anterior crus.3 These maneuvers were technically difficult to perform reproducibly with the instrumentation of the day, since surgeons of the mobilization era lacked todays improved microscope optics, bright halogen light sources, refined instrumentation, micro drills, and laser technology. There has been recent interest in re-examining the stapes mobilization techniques using modern instrumentation in an effort to reduce the risks associated with current stapedotomy and stapedectomy procedures. There remains the problem that there are many anatomical variations limiting access to the stapes footplate and anterior crus, which cannot be visualized directly in the majority of cases. Current fiberoptic delivered lasers allow the surgeon to deliver energy to portions of the stapes not even visible to the operating microscope simply by palpating the structures, but such blind maneuvers are less than favorable. This project was undertaken to determine whether endoscopic techniques with fiberoptic delivered lasers could be used for direct visualization of the stapes footplate and anterior crus during laser exposures. It was intended to study the problems that may be encountered using endoscopic techniques, to examine the available laser options, and to perform an early clinical trial of laser stapedotomies without prosthesis using endoscopic techniques in part to examine the feasibility of the technique. An assessment was made of the role of endoscopes in facilitating the Poe: Laser-Assisted Endoscopic Stapedectomy

Laryngoscope 110: May 2000

techniques, and various prototypes were studied so that recommendation for future designs could be made.

History of Stapes Surgery

Excision of the tympanic membrane and ossicles. Valsalva4 in 1704 gave the first known description of a fixated stapes and suggested that it was the cause of deafness in a patient. Toynbee in 1853 again reported ankylosis of the stapes and described the disease process of otosclerosis,5 but Wilde,6 in that same year, squelched any thoughts of surgical repair when he stated that the inner ear is never the seat of a surgical operation and cannot be examined during life. In 1876, Kessel7 recognized that the ossicles played a role in hearing and deafness. He removed the columella from pigeons and the stapes from dogs, monitoring their hearing by whistling and making other sounds while they sat quietly or slept. He noted that it required approximately 8 days for a neomembrane to cover their oval windows and restore some hearing. He concluded that removal of the tympanic membrane, malleus, or incus could be a possible treatment for deafness. In 1878, he attended a hearing impaired patient who fell off a wagon and suddenly could hear but unfortunately died of the injury.8,9 The patients temporal bones showed fractures through the horizontal semicircular canal. Kessel subsequently performed horizontal semicircular canal fractures and excision of the stapes, covering the oval window with a tissue graft, but the hearing results were disappointing. The role of the ossicles was poorly understood at the turn of the 19th century, and subsequent attempts at hearing restoration focused on excision of the tympanic membrane and various ossicles as reported by Baracz,10 Lucae,11 and Boucheron.12 Moure13 in 1880 criticized these procedures for their high failure rate and unacceptable rate of complications, but attempts to perfect the techniques continued. Miot14 in 1890 introduced Listers sterile techniques into otology, operating on 200 patients with an excision of the tympanic membrane and mobilization of the stapes. He noted that the best results did occur if the bony ankylosis of the stapes was in an early stage, and the procedure was useless for advanced stages. Blake15 in 1892 introduced the hearing restoration procedures to the United States and was the first to use the term stapedectomy. He performed 21 procedures, including 9 complete stapedectomies, 10 procedures in which only the crura fractured, and 2 procedures in which the stapes was too immobile to attempt a mobilization or removal. Vertigo was present in six of the cases. Jack16 in 1893 presented 60 cases and noted that the results were inconsistent, regardless of whether a mobilization or stapedectomy was performed. Grunert17 observed pathological changes in the round window and was one of the first to recognize that there may be a relationship between the oval and round window and that round window disease may negatively impact the results of even well-performed surgery. Siebenmann18 in 1900 was apparently very influential in abandonment of the stapes operations. He wrote that the procedures were useless and dangerous, causing cases of fatal meningitis, and that most hearing results were only temporary secondary to refixation or Laryngoscope 110: May 2000

closure of any fenestrae. Hillel,19 in a very nice description of the early history, discussed the reasons for the abandonment of stapes surgery at that time. He noted that the light sources were quite primitive and that most surgeons used a Lucae reflector, which appeared to be like a modern head mirror but was held in the surgeons teeth during surgery. There was no standardized audiometry and there were no masking techniques, so many patients probably did not have otosclerosis. There was also a severe lack of understanding of the middle ear transformer mechanism, as noted by the common practice of completely removing the tympanic membrane, malleus, and incus. Fenestration surgery. In 1897, Passow made a window in the promontory, covered it with periosteum, and noticed at least a temporary improvement in hearing.20 Thus was born the fenestration era. Floderus21 in 1899 made what he called a sound fistula in the lateral semicircular canal and noted a temporary improvement in the patients hearing. Jenkins22 in 1913 also created a window in the horizontal canal with a temporary hearing improvement. Holmgren23 in 1923 has been credited with popularizing the concept of lateral semicircular canal fenestration. He was the first to describe performing otological surgery with a 10-power microscope and a rotating burr drill, beginning the era of otological microsurgery. He performed a window initially between the oval and round window and also mobilized the stapes in one patient, achieving very good results. He then performed lateral semicircular canal fenestrations and presented his early series in 1937.24 Sourdille25 in 1924 presented a multistaged operation for creating a window in the horizontal semicircular canal. The first stage was a mastoidectomy, which was followed by a second-stage external auditory canal skin flap. Once this had healed, the third stage was performed: a lateral semicircular canal fistula that was covered by the skin flap. He later reduced this to a twostage operation. His procedure remained the standard approach until Lempert26,27 in 1938 introduced a singlestage endaural fenestration procedure, which he performed using a head lamp, magnifying loops, and a dental drill. He also had problems with bony closure of the window occurring in 35% of the patients during the first 6 months. There was a 2% incidence of complication including labyrinthine injury, infection, meningitis, and facial paralysis. He noticed that removal of the incus often improved his results and that the fenestration worked better when placed over the ampullated end of the lateral semicircular canal. Dr. Howard House8 has written a wonderful history of otosclerosis surgery and described how he studied Lemperts technique and refined it with a double blue line technique. The canal was thinned to create an island of bone overlying the ampullated end that could be flicked off the canal more easily than the eggshell fragments of the previous techniques. Shambaugh8 further refined the technique, introducing constant irrigation during the fenestration drilling. Experienced fenestration surgeons by the early 1950s were reporting 80% to 85% success rates.29 Stapes mobilization. In 1952, Rosen30 startled otologists with a reintroduction of the mobilization concept. He had intended to describe the importance of stapes Poe: Laser-Assisted Endoscopic Stapedectomy

palpation before fenestration procedures because, if mobilized, the results were less successful as a result of perilymph wave cancellation. One patient, before fenestration, had such a palpation, which mobilized his stapes and produced a dramatic intraoperative improvement in hearing and no apparent complications. By this time, the mechanics of the middle ear transformer were far better understood and preservation of the tympanic membrane and ossicular chain were of paramount concern. Rosen proceeded with five additional patients, mobilizing the stapes, and presented his successful results in 1953, receiving heavy criticism.30 He also introduced curettage of the scutum to improve exposure of the stapes before the mobilization procedure. The results seemed promising, and many otologists began using the technique immediately. Rosen first described mobilization by pressing on the stapes neck, indirectly mobilizing the footplate. As experience was gained with the technique, he and other authors reported a success rate of approximately 30% to 35%, with failures being due to disruption of the incudostapedial joint (ISJ) or fractures of the crura.29,31,32 Attention began to be directed further down the stapes, exploring the possibilities of crura manipulation or division and, ultimately, direct manipulation of the stapes footplate. Herrman33,34 pioneered the delicate, precise chisel techniques that could be used on the crura or footplate. Fowler used these techniques and began performing anterior crurotomies in limited anterior otosclerotic foci.35 He noted that with division of the anterior crus, the stapes footplate would typically fracture either through the otosclerotic focus or along a cleavage plain immediately posterior to an anterior focus onto the normally thin footplate. Surgeons using his technique increased their successful mobilization rates from 30% to between 50% and 60%. Fowler also described a partial crurectomy, removing a segment or all of the anterior crus to prevent a problem of refixation of the anterior crus. Holmgren36 also found that a partial anterior crurectomy improved the success rates over crurotomy and was even more effective when combined with intentional footplate fracture not passing through the otosclerotic focus. Goodhill29 also found improved results with anterior crurectomy and footplate fracture with good hearing results in up to 60% of patients using this direct mobilization procedure. Recurrent ankylosis of the mobilized stapes was a recognized problem, and Bellucci and Wolff37 in 1959 reported that refixation occurred in up to 60% of patients. Rosen2 presented 340 cases with a 4-year follow-up after mobilization of thin blue footplates with limited anterior otosclerosis. By 4 years, only 42% of the cases maintained their air-bone gap closure and only 32% maintained closure within 10 dB, indicating the high rate of fixation even with limited disease when fractures were made through the otosclerotic focus. It was clear that footplate fractures through the otosclerotic focus resulted in a high refixation rate. However, if the footplate fracture were made through the normal footplate, the results could be lasting, and no specific studies on that latter group of patients was reported. Goodhill29 stated that more successful long-range results can be obtained if the fracture area does not go directly through the otosclerotic process but through the Laryngoscope 110: May 2000

margin between the otosclerotic lesion and the normal footplate. A sufficient number of excellent results over long-range periods exists in this latter group to justify its retention as a valid technique under [special indications] to be utilized with a high degree of safety in the surgery for stapedial ankylosis. Juers38,39 in 1959 and 1960 presented what he called a stapedioplasty, excision of the anterior crus, anterior footplate, and mobilization of the posterior crus. Goodhill40 has termed this procedure a stapediolysis. Juers later advised separating the posterior crus from the posterior footplate and redirecting the posterior crus strut into the open anterior vestibule, which was either left open or covered with a tissue or gel foam seal. This procedure was termed by Goodhill29 to be a stapedioplasty and became his procedure of choice. At approximately the same time, Hough41 described a similar procedure in 1960, which he called a partial stapedectomy. One hundred fifteen patients had the anterior footplate segment removed, and 14 had the posterior segment removed. Patients having the anterior segment removed, including a portion of the anterior crus, had the defect in the anterior footplate covered with gel foam, allowing the posterior crus and footplate to remain intact but mobilized. Bellucci42 noted that the anterior half of the footplate was the most common site of footplate fixation by otosclerosis. Tweedle43 and Drury44 recognized a sharp line of demarcation between the otosclerotic focus on the anterior footplate and the normal bone of the footplate. Hagens45 found that the footplate bone adjacent to the otosclerotic focus usually appeared particularly rarefied, creating a fracture line or shallow crevice that could make a good cleavage plane for mobilization procedures. Goodhill and Hough have continued to perform stapedioplasty procedures. Goodhill and Harris46 have reported their work with posterior arch stapedioplasty excising the entire footplate and anterior crus but preserving the posterior crus. A tragal perichondrial boat was made to fit the oval window, and the posterior crus fit into the center of the boat. In 80% of their cases, they preserved the stapedius tendon, and they noted that 85% of cases presenting for otosclerosis surgery could have a successful operation with this technique. Hough and Dyer47 have noted that revision stapedectomy surgery is successful in less than 80% of cases and recommended that preservation of the posterior crus is important in reducing complications. They have performed a procedure similar to Goodhill and Harris in placing perichondrium over the oval window with repositioning of the posterior crus. In follow-up with 1,000 patients undergoing the technique, the air-bone gap closed to less than 10 dB in 95.7% and overclosure or complete closure in 80.5%.48 There was a decrease in speech discrimination of 10% to 19% in 0.3% of patients, and none had greater than 20% decrease in discrimination. A 5-year follow-up of that group with 200 patients49 found a 10% refixation of the posterior crus and recurrence of a 10-dB or greater airbone gap. Most of the failures responded well to revision surgery. Hough concluded that the partial stapedectomy technique was not indicated for massive obliterative otosclerosis, which occurred in 2% in his series. He found it Poe: Laser-Assisted Endoscopic Stapedectomy

advantageous to preserve the posterior crus and ISJ joint, reducing the risk of incus erosion and permitting functional and anatomical integration of the posterior crus with the oval window tissue graft, avoiding prosthesis complications. Portmann50 described another partial stapedectomy technique with excision of the entire footplate but preservation of the entire stapes superstructure, laying it on top of a vein graft to cover the window. There are temporal bone studies which suggest that fractures of the stapes footplate may heal with a fibrous union rather than refixate by osseous regeneration. Meyers et al.51 presented a 50-year-old man who underwent a successful mobilization 7 years before his death. His temporal bone showed fibrous union of an otherwise normal footplate without any osteoneogenesis, despite findings of extensive otosclerosis at the fissula ante fenestra and also much of the cochlea. Lindsay et al.52 examined the temporal bone of a patient who underwent a stapes mobilization in which the stapes subluxed into the vestibule. They found that the anterior otosclerotic focus had refixed, but the posterior portion was free of any new bone growth. Stapedectomy. John J. Shea Jr.53 in 1956 performed the first modern stapedectomy, removing the entire stapes and replacing it with an artificial nylon stapes fitted from the incus down to the oval window, which was covered by a vein graft. There ensued numerous refinements of the techniques, methods for covering the oval window, and prosthesis types.54 56 The advent of stapedectomy with a prosthesis made the stapes surgery technically more predictable and with a higher rate of success while maintaining a low complication rate. It immediately became the procedure of choice. Stapedotomy procedures using a small fenestra. Rosen in his original work had noted that occasional patients experienced a fenestration of the oval window without mobilization of the stapes and had dramatic hearing improvements, a phenomenon later studied by Fernandez et al.57 Interest returned to the concept of partial stapes footplate removal. Moon and Hahn58 found that with a partial removal of the footplate there was a slight improvement in the hearing in the 2,000- to 8,000-Hz results versus conventional stapedectomy. However, Robinson59 found no difference between full and partial removal of the footplate using a Robinson prosthesis. Experience mounted with other workers showing a consistent improvement in high-frequency hearing with small fenestra. Fisch60 in 392 patients clearly found that a small fenestra stapedotomy with a 0.4- or 0.6-mm piston gave equally good hearing results as a stapedectomy between 500 and 2,000 Hz, but better hearing results at 4,000 Hz. Persson et al.61 also compared stapedotomy and stapedectomy in 437 patients, finding better short-term results in their series with stapedectomy, but over time, the stapedectomies had a greater threshold deterioration, possibly because of a greater tendency for the prosthesis to migrate. In Sheas summary62 of his 30 years of experience, he found that his best hearing results occurred with removal of half or less of the footplate. Laser stapedotomy. Small fenestra techniques appeared to be more desirable because of the improvement in hearing in the higher frequencies, particularly 4,000 and Laryngoscope 110: May 2000

8,000 Hz, compared with conventional stapedectomy. There was also a noticeable difference in reduction of postoperative vertigo with small fenestra techniques. However, the technique was difficult because the footplate could often fracture unpredictably, and many such cases required conversion to a total stapedectomy. Interest began to emerge in the laser as a possible tool for precise bone cutting with minimal trauma. Lasers in otosclerosis surgery. It has been observed that most sensorineural hearing loss that occurred in stapedectomy or stapedotomy surgery was secondary to intraoperative trauma to the labyrinth, most commonly during footplate manipulation.63 66 A decrease in labyrinthine injury was noted with the advent of a small fenestra stapedotomy, and workers began to investigate the possibility of using lasers in a further effort to reduce labyrinthine injury. In 1965, Stahle and Hoberg67,68 published the first work involving the use of laser irradiation in otology. They employed a ruby laser on the labyrinth of pigeons and demonstrated primary thermal ablation of portions of the labyrinth, but also remote injuries attributable to presumed ultrasonic effects within the labyrinth. Similar effects were noted by Kelemen et al.69,70 in 1966 and 1967 using ruby and Nd:YAG laser in mouse temporal bones, finding internal temporal bone injury with massive cochlear duct hemorrhage and injuries to the organ of Corti and vestibular labyrinth, despite apparently uninjured overlying skin and bone. It was concluded that laser irradiation could have profound effects at depth within tissues and that great caution would need to be exercised in clinical use. Sataloff71 in 1967 used the Nd:YAG in situ on human otosclerotic stapes, but because of the lack of color, he found that there was very poor absorption of the energy. He applied copper sulfate as a blue dye and was able to produce discrete lesions on the otosclerotic bone, but copper sulfate is known to be ototoxic and would not have any clinical application. He noted that there was a risk of injury to the facial nerve through inadvertent exposure of the nerve by laser energy. The risk of this was particularly great with the invisible laser wavelengths. The argon ion laser was studied for potential intralabyrinthine injury by Stahle et al.,72 who performed guinea pig studies with the argon laser and found it was possible to destroy the intralabyrinthine neuroepithelium without damage to overlying otic capsule. Wilpizeski et al.73 in 1972 fenestrated the horizontal and posterior semicircular canals in eight monkeys with the argon ion laser. There was intralabyrinthine local fibrous reaction at the irradiation site, but it was surprising that there was only a limited decrease in the animals vestibular function and no significant reduction in hearing. Wilpizeski and Sataloff74 subsequently followed one of these monkeys over a long term and noted that it maintained normal vestibular and auditory function. When it was ultimately sacrificed, the local pathology report showed the same limited fibrous reaction around the laser site, and they concluded that argon laser lesions could produce discrete lesions in the temporal bone and may be satisfactory for human surgery. Sugar et al.75 in Poe: Laser-Assisted Endoscopic Stapedectomy

1974 exposed the cochleas of 24 guinea pigs to argon ion laser irradiation and again demonstrated that discrete lesions could be produced within the cochleas. The stria vascularis absorbed the energy most readily, and histopathological examination of the stria lesions showed quite discrete necrotic lesions surrounded by areas of lesser damage. Wilpizeski et al.76,77 subsequently evaluated Nd: YAG, argon, and CO2 lasers in squirrel monkeys. They performed myringotomies, partial tympanic membrane lysis, ossicular amputation, stapedial tenotomy, stapes crurotomy, footplate fenestrations, tympanic neurectomy, and labyrinthotomies noting preoperative and postoperative audiograms and vestibular testing. There were only minor postoperative reductions in hearing and balance function of all of these procedures. They noted that the CO2 laser had some potential with neoplasms and cholesteatoma in which the better water absorption of CO2 may prove to be more useful. They subsequently determined the parameters necessary for CO2 laser lesions on 24 human temporal bones and noted that with stapedectomy it was possible to injure the sacculus. They recommended caution in using the CO2 laser for inner ear surgery. Lyons et al.78 in 1978 used a CO2 laser on guinea pig tympanic membranes, ossicles, and cochlear otic capsules with settings of 0.4 to 30 W and a range of 50 to 100 milliseconds with a 1-mm spot size. Histopathological examination demonstrated cochlear lesions even on the lowest settings. Lasers were first used for otological application in humans in 1979 by Escudero et al.79 They had previously worked with the argon laser in dogs and rabbits. Then, using the power settings for their microscope-mounted argon ion laser, they employed it in seven patients undergoing tympanoplasty using the laser to spot-weld the tympanic membrane graft in place and demonstrating the use of the laser without any complications. Also in 1979, Palva80 became the first to employ the argon laser for otosclerosis surgery, using it for small fenestrations of the footplates in 126 otosclerosis patients. He concluded that the hearing results in the laser group were slightly better than patients undergoing mechanical small fenestration of the footplate. Perkins81 in 1980 was the first in the United States to perform small fenestra stapedotomies using an argon laser in 11 cases. He had made previous human temporal bone studies with the argon laser that had a fiberoptic cable to a microscope mounting with a micromanipulator. Using a 50- to 100- m spot size with power settings of 0.4 to 0.7 W at 100 milliseconds, he created a small rosette fenestra. He postulated that sufficient energy could be delivered to make the entire fenestra with a single laser burst but cautioned that direct laser exposure through the open vestibule must be avoided, since water does not absorb the argon wave length at 488 nm. He believed that, since the beam was focused at the footplate, the significant divergence of the beam as it entered the labyrinth would be somewhat protective to the neuroepithelium. He used the same power settings on 11 patients with a focal length of 160 mm on the microscope. The tendon and posterior crus were lysed with the laser, using a suction to Laryngoscope 110: May 2000

remove the vapor plume. Then the footplate was eradicated over a several-minute period to minimize any thermal effects on the labyrinth. He made a circular rosette and picked out the intact central bone. In one case, the bony disk fell into the vestibule but did not create any complications. All of the cases were successful. There was no incidence of sensorineural hearing loss, and there was a near-absence of vertigo other than some mild positional dysequilibrium, in significant contrast to prior experience with conventional mechanical footplate dissections. Limited electronystagmograms (ENGs) were performed on eight of the patients on the second postoperative day and showed no spontaneous nystagmus. Later in 1980, DiBartolomeo and Ellis82 presented a series of patients undergoing argon otological procedures including 7 tympanoplasties, 1 keratoma pearl, hemostasis in the middle ear, 2 cases of lysis of middle ear adhesions, 4 myringotomies with tube placements, 2 excisions of external auditory canal osteoma, 3 ossicular sculptings, and 10 stapedotomies. One of these cases had a stapedial artery that was divided bloodlessly using the laser. Two of the cases had obliterative otosclerosis on the footplate, and the laser was used to drill out the footplate, opening the vestibule without any drill vibration or apparent generation of heat to the labyrinth. Laser impulses were given over 1-second intervals on the footplate, and the patients were all under local anesthesia and reported no vertigo. There was no significant sensorineural hearing loss postoperatively in any case. The authors had performed preliminary temporal bone work in seven temporal bones to determine power settings and used a 250-mm focal-length argon ion laser with a spot size of 90 m and 0.1 to 0.3 W over a 0.1- to 1.0-second duration. They concluded that it was a useful technique and had great promise in facilitating stapes surgery and reducing complications. They noted that the argon laser was particularly good for hemostasis during stapedotomy and would most likely prove useful in hemangioma, telangiectasia, and tattoo removal. The CO2 laser was investigated for otological surgery by Lima and Wilpizeski83 in 1980, who performed tympanic neurectomies in several squirrel monkeys with the CO2 laser. They demonstrated no sensorineural hearing loss either on auditory brainstem evoked response (ABR) testing or with behavioral auditory testing. They concluded that the CO2 could be used without significant cochlear effects. These early works launched tremendous controversies over the optimal type of laser that should be used in otological surgery, and for what purposes. DiBartolomeo84 next compared argon and CO2 lasers for otolaryngological uses. He found the CO2 laser to be useful in neurootological soft tissue, but the argon had significant advantages, since it used a visible beam and had a smaller spot size. He noted that the wavelength of the argon laser allowed passage through the labyrinth and postulated that this could be protective to the labyrinth as opposed to the CO2 laser, which was predicted to risk boiling perilymph on exposure to an open vestibule. Wilpizeski85 disagreed with these concepts and believed the CO2 could be useful and safe in otological surgery. Poe: Laser-Assisted Endoscopic Stapedectomy

Epley86 began using the CO2 laser initially in cadaver specimens on the tympanic membrane and determined appropriate settings of 1 to 2 W on continuous-wave mode with a spot size of 1.5 mm and a 300-mm focal length. He then removed superficial lesions from the tympanic membrane in 10 patients. He described a slow movement in the continuous-beam CO2 laser over the target until char had developed. He manually removed the char and found that there were no instances of tympanic membrane perforations. He concluded that the CO2 laser with very well-controlled techniques could produce excellent hemostasis and ablation of lesions with very controlled depth of thermal injury. Williams et al.87 used the CO2 laser to perform myringotomies and middle ear lesions in four cats. The settings were 8 W over 50 milliseconds. Histopathological examination and scanning electron microscopy did not demonstrate any injury to the cochlea, and the authors concluded that the CO2 laser could, indeed, be safe for middle ear use. The argon laser was used by Glasscock et al.88 in acoustic neuroma surgery using settings of 3 to 3.5 W, 0.1 second, with a 250-mm focal length. He noted significant practical problems using the microscope-mounted micromanipulator delivery system. It increased the working distance of the operating microscope because of the laser attachments and decreased the available light because of the micromanipulator beam splitter. The recommended techniques of bouncing the laser beam off mirrors to reach otherwise inaccessible locations was quite impractical and difficult to perform. One of the surgeons hands had to be removed from the operating field simply to operate the joystick of the manipulator, and there was such relative movement of the patient versus the microspot that under high power, the laser application may require synchronizing with the patients ventilations. The authors concluded that, although the laser was an important advance, there were definite technological obstacles to be overcome. Vollrath and Schriener89 carefully examined the effects of the argon laser on the labyrinths of guinea pigs. They used a 488-nm argon ion laser that was microscope based with a spot size of 150 m in a guinea pig model. Thermocouples were placed into the second coil of the cochlea or into the round window. Reproducible bone perforations in the cochleas required energy settings of approximately 2 W and 0.5 seconds. They found that the water content and color of the tissues greatly influenced the laser absorption. Wet bone did not absorb energy as well, probably because of a cooling effect. Pigmented tissues such as vessels and stria vascularis had increased laser absorption. Laser-irradiated tissue could produce a white ash, which almost completely reflected subsequent laser energy and eliminated its effects. Exposures on the guinea pig cochleas were then performed, and temperature elevations of 8C to 10C were measured. After a perforation was made into the stapes, irradiation into the open vestibule produced an elevation of perilymph temperature by 10C as measured at a 2-mm distance. If the probe were placed immediately beneath the footplate, temperature elevations of 80C to 100C degrees were recorded! It required about 40 seconds between each laser impact for the temperature to return to baseline. Laryngoscope 110: May 2000

The effects of laser irradiation on cochlear microphonics (CM) and cochlear action potentials were next investigated.90,91 The impact of a single argon laser impulse on the stapes footplate produced a decrease or complete loss of compound action potential (CAP) for more than 40 seconds, but the CM was lost for only about 2 seconds. The 40 seconds required to restore the CAP coincided with the time necessary to return the temperature back to baseline. The researchers also noted that there was a transient initial response in the CAP to the laser impact which probably corresponded to the noise of the laser impact. During the course of these measurements, they noted that a direct current extracochlear potential92 was produced from the laser impulses, which they believed to be due to laser heat injury to the cochlea or bony cochlea. They noted that continued exposure of more than 1 second could boil perilymph. As a result of these very well-conducted studies, they concluded that color, the absorption coefficient of stapes bone, and thickness of the stapes all affect laser-induced endocochlear changes through the degree of thermal injury and sound pressure of the laser impact. The laser-induced transients interfered with the inner ear function as noted by the transitory reduction or complete loss of CM and CAP. Therefore there was a significant potential for laser injury causing permanent cochlear damage and sensorineural hearing loss. They measured the sound level of the noise impact at approximately 80 dB sound pressure level (SPL), and they believed that an acoustic shock of this magnitude was insufficient to induce significant acoustic trauma. They recommended avoiding direct laser exposure of the perilymph and allowing sufficient time between laser impulses to avoid summating temperatures within the labyrinth.93 Thoma et al.94 made similar sound level recordings in argon laser exposed temporal bones, noting the sound injury to be approximately 59 dB SPL. Injuries with the argon laser were created by Gantz et al.95 in 1982, who performed eight stapedotomies in seven cats using previously determined argon laser settings for footplate fenestrae of 1.5 W, 0.1 seconds. The authors found that the sacculus was perforated in three of the ears, although the maculae remained intact. The relative absence of pigment in the footplate increased the number of pulses required for perforations, and they concluded that the argon laser still required further investigation because of the potential problem of variable absorption of the energy on the footplate depending on color differences between individuals. The pendulum swung back to CO2 lasers, and Goode96 performed preliminary human temporal bone and cat studies with CO2 using settings of 200- to 400-mm focal length, 1- to 2-mm spot size, 10 to 16 W, at 0.1 seconds. He performed laser myringotomies in 11 patients, all without complications, noting that the high water absorption of the CO2 laser was favorable for this purpose, since middle ear effusions nicely protected the cochlea. Gardner et al.97,98 used the CO2 laser for acoustic neuroma surgery, finding that the tumor mass could be rapidly reduced with minimal manipulation and that defocusing the beam was particularly useful for vaporizing the tumor. They believed that there was better control of Poe: Laser-Assisted Endoscopic Stapedectomy

the thermal effects over argon or Nd:YAG lasers. They also performed human temporal bone studies with the CO2 laser on the stapes superstructure and footplate with settings of 4 to 5 W, 0.05 seconds, and 0.45-mm spot size. Temperature effects in the vestibules were noted, firing into an open footplate. The vestibule full of fluid had an elevation in temperature of 1C, but if the vestibule were dry, the temperature elevation was 11C to 19C. They laser-irradiated the ossicles and footplates of seven cats and found that the histopathological result was limited only to the bone itself, with no effects on the membranous labyrinth. They noted that the facial nerve and footplate could be easily protected during ossicular surgery by simply covering them with saline or wet cotton. Their conclusions were that the CO2 laser probably had fewer risks than the argon laser because of its high water absorption. The CO2 laser was not free of potential complications. Coker et al.99 and Thoma et al.100 performed thermal studies in cats and human temporal bones with the CO2 laser and at higher settings demonstrated thermal injury to the vestibule, reaffirming the need for caution. The pendulum continued to swing, and McGee101 in 1983 presented 100 patients who had small fenestra stapedotomies with an argon laser. He found that the laser had three functions including vaporizing tissue, cutting of tissue, and coagulation of vessels for improved hemostasis. Using the laser, there appeared to be a reduction in surgical trauma with less vertigo postoperatively and a decrease in the length of stay in the hospital. Small fenestra stapedotomy patients normally required a stay of 2 or more days in the hospital versus the laser patients, of whom only 27% remained in the hospital 2 or more days. The hearing results between the two groups were comparable. He concluded that the laser was effective and safe and that some tasks could be performed with the laser with less trauma that conventional techniques. His follow-up study102 in 1989, with 510 cases of primary stapedotomy, bore out these early conclusions, demonstrating no complications at all related to the laser and a change in hospital stay with the vast majority of procedures being performed on an ambulatory basis. He believed that improved hemostasis and reduction in oval window trauma with decreased vertigo were responsible for these improved results. Ricci and Mazzoni103 performed argon laser irradiation on human temporal bones using a microscope-mounted laser with a 165- m spot size, 0.05-second pulse duration, at 0.4 to 0.6 W and noted the increase in temperature within the vestibules to be within 3.5C using single shots. The authors noted that it required about 30 seconds to return the temperatures to baseline, confirming some of the work previously performed by Vollrath. The authors described the 3.5C temperature elevation as modest and unlikely to be of clinical significance. In the mid 1980s, the potassium titanyl phosphate (KTP) laser came into clinical use and was noted to have effects similar to the argon laser because of its very close wavelength.104 Lesinski and Palmer105 decided to confront the swinging pendulum and undertook an in-depth comparative study of argon ion, KTP, and CO2 lasers in otology. They performed temperature measurements in the vestiLaryngoscope 110: May 2000

bule using a paraffin model of the vestibule with human cadaver stapes placed in the models oval window. First, argon 514-nm and KTP 532-nm, both microscope-mounted with a micromanipulator, were compared. Settings of 2 W with a spot size of 50 to 500 m were evaluated with 0.1-second pulse duration. They performed rosettes on the footplates using overlapping laser burns and nonoverlapping laser burns. If there was no overlapping of the burns, the maximum temperature elevations were 0.4C using the 50- m spot size. If the spots were overlapped, the maximum temperature elevation was 4.3C to 6.3C. Then they used a thermocouple that was blackened to ensure energy absorption by stray laser irradiation, and this was placed 2 mm deep to the open footplate in the path of the laser. The KTP laser was fired into the open vestibule with a 100- m spot size producing an elevation of temperature of 21C, and this was raised to 52C if the spot size was reduced to 0.05 mm. Then a fiber-delivered KTP laser was used with a 0.4-mm-diameter fiberoptic probe placed at the opening of the footplate and therefore 2 mm distant from the black thermocouple. Temperature elevation was noted to be 12.9C. It was noted that the fiber was not collimated compared with the collimated beam from the microscope micromanipulator delivery system, and the fiber was more defocused with a greater angle of divergence compared with the microscope. It was noted that these temperature elevations would be insufficient to cause vaporization of the membranous labyrinth, although the amount of thermal injury was not known, given these transient temperature elevations. The micromanipulater argon laser trained into the open vestibule with a 50- m spot size produced a temperature elevation of 175C. Later reports106 showed that if the argon was used with a spot size widened to 200 m, temperature elevations through the open vestibule were only 4C to 6C. The elevations to 175C prompted great concern and predictions of dead ears with further use of argon lasers.107,108 Lesinski and Palmer109 next examined CO2 lasers as an alternative. The CO2 laser (with settings of 0.6-mm spot size, 3.6 W, 0.1-second duration on superpulse setting) irradiating the stapes produced an elevation of 0.2C to 0.3C. When the vestibule was opened, the temperature elevation was only 0.5C. The authors concluded that argon and KTP lasers could be used safely if careful techniques were observed and operation was performed only in primary cases. Revision cases had a greater chance of exposure through an open vestibule, and only CO2 would be recommended for revision surgery. Histopathological temporal bone specimens having undergone stapedectomy have demonstrated adhesions between either the prosthesis or the neomembrane in the oval window and the utricle or saccule.110,111 It was concluded that the increased risk of sensorineural hearing loss in revision stapedectomy could be due to direct manipulation of the neomembrane rupturing the membranous labyrinth. It was hoped that laser techniques could reduce this problem in revision operations. Lesinski and Stein112 presented 59 cases of revision CO2 laser stapedotomy. Two of the 59 patients (3%) had greater than 15 dB sensorineural hearing loss at 4,000 Hz, Poe: Laser-Assisted Endoscopic Stapedectomy

and none of 59 patients had greater than 10 dB sensorineural hearing loss between 500 and 3,000 Hz. It was concluded that use of the CO2 laser was helpful for atraumatic vaporization of adhesions in revision cases without causing any significant caloric effect or injury to the vestibular structures. There was no case of significant sensorineural hearing loss. The same authors presented 153 cases of primary stapedotomies performed with a CO2 laser and reported no significant intraoperative or immediate postoperative vertigo.113 The vertigo symptoms were dramatically reduced compared with standard stapedectomy techniques. Seven of the 153 cases showed a decrease greater than 10 dB at 4,000 Hz, and there were no cases of sensorineural hearing loss greater than 10 decibels between 500 and 3,000 Hz. The controversy over choice of laser was far from concluded. Gherini et al.114 and Causse et al.115 reexamined Lesinskis data to see why the clinical experience with the argon laser did not bear out the early predictions of severe hearing loss attributable to thermal injury from exposure through the open vestibule. The experiments were repeated through a vestibule model using human cadaver stapes and a silver-colored thermocouple that was not blackened. The authors thought that use of a blackened thermocouple caused excessive energy absorption that was not physiological. They used a fiberdelivered argon laser with 514 nm delivered with a fiberoptic probe with a 0.2-mm diameter and with power settings of 2 W and 0.1 seconds, using 10 to 15 seconds duration between pulses. They found no discernible elevation in temperature at all when the vestibule was filled with saline duplicating physiological conditions. If the saline were removed and the fiberoptic laser aimed directly at the thermocouple, temperature elevations as high as 85C were recorded. The temperature of the laser plume reached 80C but did not affect the thermocouple within the vestibule. They calculated the power density settings used in Lesinskis argon laser work to be 101,859 W/cm2 versus 6,366 W/cm2 in their study with the fiberoptic probe. They noted that in clinical practice they normally used between 3,183 and 4,775 W/cm2 with 1- to 1.5-W settings. They pointed out a number of advantages in the fiberoptic delivery system. The fiber, because of its higher divergent beam of 14 degrees, rapidly dissipates the power density and therefore is more safe than a focused microspot. The fiber works best within 1 mm of the target and reduces risks of inadvertent injury to the facial nerve, membranous labyrinth, or other structures. They found that settings of 1 to 1.5 W were sufficient to vaporize the thin bone of the stapes, and with these settings there was no lateral energy dissipated, as could happen from errant reflections off a micromanipulator-delivered beam. The fiber probe cannula could be heated with repeated use, and they recommended waiting between shots to allow heat dissipation. They noted that the argon wavelength absorbed best in the red pigments and that, by holding the fiberoptic probe slightly off capillaries, it could be used for coagulation and to improve hemostasis. They concluded that the fiberoptic system was more clinically useful than CO2 because it delivered the energy more precisely to the exact location for intended use with less Laryngoscope 110: May 2000

risk of harmful errant irradiation. The results seemed to correlate with the authors combined clinical experience in more than 2,200 clinical cases of primary and revision stapedotomies performed with the handheld fiberoptic system without any incidence of significant sensorineural hearing loss or permanent facial nerve injury. Similar experiences were subsequently reported using handheld fiberoptic probes by Gherini et al.116 Silverstein et al.,117 and others.116,118 129 Silverstein did emphasize exercising caution even with argon techniques, noting that one revision stapedectomy had a speech discrimination decrease down to 40% and another developed a granuloma in the tympanic membrane flap that filled the middle ear, spread into the oval window, and created a dead ear. He concluded that the laser technology certainly did not remove the risk of complications in stapes surgery. Vernick sought to compare the performance of visible and IR lasers in a clinical series and performed 100 small fenestra stapedotomies with two different microscopemounted lasers. The KTP laser was used in 52 cases, and the CO2 in 48 cases. He found no difference in the results between the two and concluded that the laser improves the surgeons footplate techniques. He also cautioned that it should not be assumed that there would be a decreased risk for sensorineural hearing loss in occasional or resident surgeons simply because the technique was easier. He cautioned that the choice of laser should be based on ones personal training and laser availability and that the choice of wavelength was a less significant issue. Stapes conservation techniques in otosclerosis surgery. Many authors have written about techniques to preserve portions of the stapes and stapes tendon during stapedotomy surgery, but the benefits of such techniques have not been universally accepted.46,47,130 There has been considerable debate concerning the importance of the stapedius tendon and the loss of function that may occur with its division. Mller131 has demonstrated that acoustic reflexes produce hearing attenuations of 10 dB for stimulus frequencies below 1,000 Hz with little effect at higher frequencies. Based on those early observations, it has been thought that the benefits created by stapes tendon function may be of minimal residual importance. More recent studies, however, have called this concept into question. Colletti et al.132 performed stapedectomies in 362 cases, stapedotomy with lysis of the stapedius tendon in 236, and small fenestra stapedotomy with stapedius tendon preservation in 207. They found that there was no difference in the hearing results from 500 to 2,000 Hz. There were improved hearing results in the stapedotomy patients of both groups at 4,000 and 8,000 Hz compared with stapedectomy. Improvement in hearing at 8,000 Hz occurred only in the stapedotomy groups. The patients in whom the stapedius tendon was preserved demonstrated a better speech discrimination in background noise, and the noise masking effects were even worse in the stapedectomy group compared with the group having stapedotomy without tendon preservation. Complications included dizziness, cochlear loss, slipped prosthesis, incus necrosis, and fixed footplate. The incidence of complications was lower in the stapedotomy group versus the stapedectomy group. Poe: Laser-Assisted Endoscopic Stapedectomy

The exact role of the stapedius muscle and tendon remains uncertain. Von Bksy133 made observations of the stapedius tendon and its effects on movement of the stapes footplate. He noted that the tendon pulled the stapes posteriorly, anchoring the footplate against the posterior annular rim and causing the stapes to tilt around the fixed posterior rim. He postulated that acoustic movement of the stapes might involve similar rotation about the posterior rim. Vlaming and Feenstra,134 with laser doppler analyses of fresh human cadaver stapes, found that the stapes had a more true piston-like movement, rather than tilting about a posterior axis, and raised the question as to the role of the stapes tendon in creating a different axis of stapes motion. Pang and Peake135 analyzed stapes movements in 17 cats with the tensor tendon divided and with acoustic reflex actions blocked by anesthesia. The authors maximally stimulated the stapedius muscle with alternating currents for more than 30 seconds, measured ossicular chain displacements with stimulation levels of 100 to 10,000 Hz at 65 to 85 dB SPL, and measured the cochlear potentials. They found that the stapedius contraction increased the stapes impedance by effectively increased mechanical strain on the annular ligament. They noted that the modest attenuations in sound transmission documented in prior studies eliciting the acoustic reflex may have been limited to submaximal stimulations. Conceivably, the brain could cause much stronger contractions, as seen in their study using direct electrical stimulation. They further noted that contraction of the stapedius tendon produced motion only of the stapes and not of the incus or malleus. Similarly, tensor tympani stimulation produced only movement of the malleus, not of the incus or stapes. Therefore the brain could be capable of independently contracting these muscles for purposes that could modulate sound perception, or they could be contracted together in maximal efforts to produce far greater effects on increasing the impedance of the middle ear transformer than had been previously appreciated. Causse et al.115 have reconstructed the stapedius tendon with a specially designed prosthesis which they used in over 3,400 patients. They found that the hearing results for word discrimination were better in background noise than in patients without tendon reconstruction, and the effects were particularly noticeable in the highfrequency hearing perception. There was also a subjective report of decreased hyperacusis compared with prior patients. Causse et al. noted that the stapes tendon can be observed to contract even when patients speak and is most likely important in modulating sound perception in background noise, which would be consistent with the observations of Pang and Peake. Causse et al. believed that protection against acoustic trauma is primarily the function of the annular ligament. Dr. Loren Bartels suggested that laser techniques could be used to perform an anterior crurotomy and division of the stapes footplate to eliminate a prosthesis in some cases (personal communication, 1994). In 1997, Silverstein1 presented his early clinical experience using laser stapedotomy techniques without use of a prosthesis to maximize stapedial function. All cases had minimal otosclerosis and were performed using the Laryngoscope 110: May 2000

handheld, fiber-delivered argon laser. He described bending the laser tip to a 30-degree angle to vaporize the anterior crus, which often had to be performed blindly underneath the incus. The scutum usually required more curettage than is customary for stapedotomy to manipulate the bent fiber between the crura, to adequately reach the anterior crus. He used a 1.5-mm right-angle pick to palpably confirm that the crus was divided, if it could not be directly visualized. Then the laser was used on thin blue footplates dividing between the anterior and middle one-third of the footplate. Small picks were used to ensure that there was complete transection of the footplate and that the posterior segment of the footplate had been mobilized. There was a separation of approximately 0.5 mm between the two segments, and fat was placed over the separation to prevent fistula. If the cases were not adequately mobilized, they were converted to a stapedotomy, creating a Rosette and inserting a prosthesis in a conventional fashion. The stapes capitulum was preserved whenever possible, leaving its tendon attachment in an attempt to preserve stapedial tendon function. The indications for this procedure were otosclerosis limited to the anterior footplate and a blue stapes footplate. He cautioned that the surgeon must be prepared to perform an ordinary stapedotomy with prosthesis insertion. If the posterior segment was adequately mobilized, results showed an average air-bone gap closure to 2.6 dB that remained at 2.4 dB after 1 year. There was no change in speech discrimination in any patient, and there were no complaints of hyperacusis subjectively in the group. Two patients had inadvertent fracture of the posterior crus during the procedure and had conversion to pistons. He noted that the stapedotomy without prosthesis procedure could be performed successfully in 38% of cases undertaken for otosclerosis surgery. He thought that with better techniques, as many as 45% to 50% of otosclerosis patients could be candidates. He concluded that the advantages of the stapedotomy minus prosthesis procedure were preservation of the tendon with an improvement in hearing, better speech discrimination in background noise, and reduction in hyperacusis. There could be no prosthesis complications; therefore it was providing a minimal operation for minimal disease preserving the majority of the natural stapes function. He believed that possible benefits could include, with increased experience, a reduction in length of procedure, reduction in risk for inner ear injuries, and decreased risks in the face of barotrauma, particularly in scuba divers. It would appear that today the concept of stapes surgery has returned to the original procedures in which the stapes itself could be merely mobilized, but technological advancements have made the procedures easier to perform and with more predictable and reliable satisfactory results, with a dramatic decrease in the incidence of morbidity. These achievements have been gained through better understanding of inner ear and middle ear physiology and with the development of improved techniques, precise laser technology, and the concepts of small fenestration or minimally invasive procedures on the stapes footplate. Today it is known that stapes mobilization alone through the otosclerotic focus has a very high incidence of Poe: Laser-Assisted Endoscopic Stapedectomy

refixation. Theoretically, it was predicted by the stapes mobilization surgeons that division of the stapes footplate posterior to the otosclerotic focus could give indefinite hearing improvement and would not necessarily result in refixation unless the otosclerotic focus were to continue growing. The difficulties encountered in producing the precise cuts necessary for mobilization of the posterior stapes segment are a testament that further refinements in the technology and techniques are needed before such procedures can become available for general use. Longerterm follow-up of patients undergoing surgery without a prosthesis are needed to determine the incidence of refixation. The present study was undertaken to improve on the techniques available to visualize and operate on the stapes footplate. Small-diameter endoscopes were studied for their ability to improve visualization of the stapes footplate and anterior crus.136,137 Alternative laser technologies were also investigated to determine whether they may prove more useful in otosclerosis surgery.

Investigation of New Lasers for Otosclerosis Surgery

Lesinski and Palmer105 noted that the ideal laser for otosclerosis should have the following properties: 1) precise optics for delivery, 2) a predictable lasertissue interaction with both bone and collagen, 3) no penetration of perilymph, and 4) no heating of perilymph. They noted that none of the existing lasers had ideal characteristics. Visible lasers had problems with energy absorption that varied depending on different tissue colors, problems with thermal scatter, and unlimited penetration through clear water. The CO2 laser had near-ideal tissue absorption characteristics but was more difficult to use optically because it could only be delivered with a microscope micromanipulator arrangement. As an invisible laser, it required a coaxial aiming beam that had problems of inadvertent dissociation from the true laser and chromatic aberration between the CO2 and shorter aiming-beam wavelengths, so it was impossible to focus both the CO2 laser and aiming beam on exactly the same spot. Therefore the authors concluded that visual lasers have optimal characteristics for delivery but suboptimal tissue characteristics and that the CO2 laser had optimal tissue characteristics but suboptimal optical characteristics. The search for an ideal otological laser has been directed toward development of a laser with good water absorption characteristics that could be fiberoptic delivered. Such a laser would enjoy the benefits of the best aspects of a CO2 and argon or KTP laser. Water absorption is optimal in the IR frequencies, which are also invisible. A fiberoptic delivery system would be one possible solution for aiming an otherwise invisible laser. To date, CO2 has not been available through a fiberoptic delivery system, with the exception of thin hollow metal tubes called wave guides that are rather rigid and clumsy to manipulate, or silver halide fibers, which are relatively thick in diameter and extremely toxic to tissues, making them unlikely to be useful in surgery. Therefore the search has focused on alternative wavelengths for lasers Laryngoscope 110: May 2000

in the mid-IR range where the water absorption peaks are favorable. Pulsed infrared lasers. The emerging lasers in the mid-IR region have been pulsed lasers to date. Argon and CO2 are continuous-wave (CW) lasers, and KTP is a Q-switched (chopped) laser. The pulsed lasers work by storage of large amounts of energy which is suddenly dissipated in a massive release that generates the laser emission in very short bursts. These high-energy bursts rapidly exceed tissue vaporization levels with efficient tissue ablation that reduces the total energy required for ablation compared with CW lasers. Pulsed lasers lose less energy to adjacent thermal spread, yielding a better quality of perforation with lower lateral thermic effects verses CW lasers. The extremely-high-energy bursts over very brief time produce a transient plasma explosion with nonlinear (out of proportion for the amount of energy) acoustic effects not found in the CW lasers that follow only linear photothermal properties (increased energy yielding increased thermal damage). Many studies have investigated pulsed lasers because of their highly desirable wavelengths and excellent bone-cutting characteristics, but the acoustic shock wave has been found to be a potentially serious barrier for their use within the ear, particularly on the ossicular chain or within the labyrinth. Nonlinear explosive properties of pulsed lasers were studied by Esenaliev et al.138 measuring the acoustic and shock waves generated by a XeCl (excimer) laser. The acoustic wave generated by the pulsed heating of irradiated tissue caused a pressure wave termed a thermooptical acoustic wave. The shorter the pulse, the greater the acoustic effect, particularly when the duration of the pulse was less than the duration of the stress relaxation time as the tissue recoiled from each pressure wave. The pulsed or explosive ejection of tissue ablation products caused a compression and rarefaction recoil pulse that propagated through tissues and could cause significant injury even at remote distances from the laser pulse. The velocity of the pressure wave increased with increased amplitude of the wave, which in turn was affected by increased laser energy or shorter pulse duration. All of the acoustic effects caused tissue stresses and generated energy below levels required for tissue ablation, so no secondary vaporization of tissue would be expected to occur but widespread necrosis could result. Czurko et al.139 measured similar in vivo effects using pulsed holmium (Ho:YAG [2.1- m]) and Nd:YAG (1.06- m) lasers. The Ho:YAG was used with pulses of 1.5 J and 200microsecond durations in rat brains, and the researchers found that there was a microexplosion at the point of laser impact and a secondary pressure wave that penetrated deep through the brain tissue. The result was local and remote compressive tensile, torsional, and sheer forces exerted on the brain that depended on the direction of incident beam and its amplitude, frequency, and pulse duration, as well as damping oscillations of the pressure wave which was tissue and bone dependent. The authors conceded that the rat brain was quite small and that the magnitude of the injuries could not necessarily be extrapolated to large mammal brains. Nevertheless, they recommended that, when pulsed lasers are used clinically, the Poe: Laser-Assisted Endoscopic Stapedectomy

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energy of each pulse should be kept as low as necessary and the pulse length be made as long as possible. The number of laser pulses should be kept as low as possible to minimize injury. There has been growing concern about the effect of the acoustic pressure waves in the ear causing mechanical destruction and auditory impact acoustic injury with potential labyrinthine injury and sensorineural hearing loss. Luz140 determined in rhesus monkeys and humans that temporary and latent threshold shifts can occur with impulse noise of 168 dB SPL or greater. The CW lasers have been previously noted to have impulse noises under 100 dB and lack a significant acoustic shock wave, which would most likely account for the favorable results in otosclerosis surgery. However, these levels have not been adequately studied for the newer pulsed lasers, nor have adequate histopathological studies been made with in vivo experiments using pulsed lasers. Initial interests focused on the Ho:YAG (2.1- m) lasers because of their precise bone-removing properties, reasonable soft tissue coagulation, and fiberoptic transmission, as noted by Shapshay et al.141,142 and Pfalz et al.143 Bone cutting was suboptimal with the Ho:YAG laser with significant bone blackening during penetration and considerable deposits of residual melted bone along crater edges. In contrast, the erbium (Er:YAG or Er:YSGG [2.94or 2.79- m]) laser had the disadvantage of micromanipulator delivery but had much cleaner bone-cutting characteristics compared with Ho:YAG, which caused bone blackening during penetration.141,143 Nuss et al.144 observed favorable linear relationships between the amount of energy delivered and the mass loss above ablation threshold levels in tissue using mid-IR lasers. Erbium laser. The erbium laser has subsequently been investigated more closely for ear surgery because of its clean bone-cutting characteristics and wavelength of 2.9 m lying close to the maximal peak of water absorption (3.00 m) in the visible and IR spectrum. Shah et al.145 examined the Er:YSGG (2.79- m) laser for the possible ossicular surgery using a micromanipulator-delivered, microscopemounted system. Temperature measurements were performed with a thermocouple placed in the vestibule of live rats but not in the direct path of the laser. Ten pulses on the stapes footplate produced a 2.0C elevation in temperature. This was in reasonable comparison to previous work by Li et al.146 demonstrating a 4C elevation with the erbium laser striking rat femurs in a saline bath. It was noted that, since only the first pulse sees virgin bony tissue, the secondary pulses arrived impacting tissues of varying water content and temperature. Water absorption with the erbium laser decreased as temperature increased. Therefore, increased care would be needed when impacting previously exposed sites, since the energy absorption would be decreased. It was noted that the erbium laser was capable of very precise bony ablation and very limited collateral damage with much less char than either CW or superpulsed CO2 lasers. The erbium laser was intensely absorbed by water and collagen and also by the bone minerals calcium phosphate and hydroxylapatite. The excellent absorption of the laser energy meant the majority of energy was consumed by tissue ablation and ejection of debris, leaving minimal residual energy to dissiLaryngoscope 110: May 2000

pate into adjacent tissue causing thermic injuries. The erbium laser was quite effective in division of the stapedius muscle, tendon, temporalis fascia, and muscle. Hemostasis was quite limited, since it principally worked by thermal coagulation of the vessel, not by hemoglobin absorption. It worked best on small vessels where absorption into the vessel walls would allow flattening and coagulation. It was noted that there was a loud pop when the laser impacted the bone, indicating a significant acoustic shock phenomenon. The amplitude of the pop could be reduced if the tissues were wet. The acoustic shock nonlinear effects for the erbium lasers have been further studied using pressure transducers and optical flash photography. The Er:YSGG laser exposed to an aqueous medium produced vapor channel formation to depths of 1.5 mm that collapsed, creating transient bubble formation and a secondary pressure wave.147 The effect summated with multiple pulses.148 The acoustic effects were measured by Pfalz et al.143 using SPL recording equipment to record laser impact noises on bovine stapes. Sound levels for different lasers were as follows: Er:YAG (2.94- m), 133 dB SPL; CO2, 135 dB SPL; and argon, 92 dB SPL. These researchers and others149 thought these were acceptable acoustic levels for clinical use. Another study by Li et al.146 using Er:YAG on a rat femur produced photoacoustic waves between 99 and 121 dB; the authors also thought this was within acceptable clinical limits for human surgery. Sound-level studies of the laser impact have not taken into account the photomechanical effects of the nonlinear acoustic shock wave. The mechanical injury from the shock wave could be expected to add to the potential noise-induced injury in vivo, particularly if the stapes footplate were penetrated and the shock wave were directly propagated into the perilymph. Noise injury from the erbium laser was studied in vivo by Varvares et al.,150 who measured CAP auditory thresholds in guinea pigs subjected to Er:YAG (2.94- m) laser. They performed precise bone cuts on the stapes of 16 guinea pigs while monitoring CAP recordings. Pulses of 10 to 55 mJ with an average of 20 mJ per pulse were used with a power density of 3.9 to 21.6 J/cm2 using a spot size of 570 m with a micromanipulator delivery system. When footplate fenestrations were incomplete, there were no threshold shifts in the CAP readings. Once a fenestration had occurred, there were 10- to 30-dB hearing losses between 1,000 and 10,000 Hz. If only the otic capsule were opened over the cochlear promontory, a hearing loss occurred only above 20,000 Hz. In comparison, the otic capsule over the cochlea was opened with an argon ion laser and showed similar injury above 16,000 Hz. The noise generated by laser impulse stress transients was significantly higher in the perilymph. Bone is 10% to 20% water and perilymph is nearly pure water, with a 5 to 10 times higher absorption of erbium energy per volume creating much greater stress transients because of the rapid water ablation with the pulsed laser effect. These stress transients were probably responsible for organ of Corti injury both by acoustic noise-induced injuries and mechanicalto-electrical transducer injuries of the hair cell mechanisms. Injury to the high frequencies was consistent with Poe: Laser-Assisted Endoscopic Stapedectomy

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this mechanism, since they were the closest to the site of the transients lying at the basal turn of the cochlea. In a contrasting study, Jovanovic et al.151 performed similar experiments with the erbium laser on guinea pig cochleas. They used an Er:YSGG laser with 85 mJ per pulse and 36 J/cm2 in 20 guinea pigs and found no change in the CAP when the laser impacted the intact cochlear promontory bone. After a cochleostomy was made, an additional 25 laser impacts for a total of 2.1 J continued to show no change in the CAP but 50 applications (total of 4.2 J) showed some variable and partially irreversible CAP changes. Seventy-five applications (total of 6.3 J) deafened the ears. The authors concluded that at the lower number of applications, which would normally be used for stapedotomy techniques, the laser should be safe. Unlike the work by Varvares et al., however, these authors did not impact the ossicular chain or penetrate the stapes footplate, which certainly would be expected to have an amplifying effect on the injury as demonstrated in the previous study confirming hearing loss with similar energy levels. Jovanovic et al.152 used pulsed laser systems on cadaver stapes and bovine compact bone platelets to simulate stapes. They tried the excimer laser (308 nm) but found very poor ablation rates. Ho:YAG laser was possibly suitable for stapedectomy, but the Er:YSGG laser had the highest ablation rate of bone and was deemed to be the most potentially effective for surgical use. The tissueablating effects of the pulsed laser systems through photograph ablation permitted precise and controlled stapes footplate perforations using low energies with reproducible ablation rates. The extent of thermic side effects at the footplate was reduced compared with pure thermicacting CW or superpulsed lasers. Temperatures were measured in a cuvette covered with a stapes footplate firing on the footplate. The Er:YSGG laser produced a 3.6C elevation, 2 mm from the footplate, and the CO2 laser, 8.8C. The authors found that, because of variations in the thickness of the stapes footplate, the pulsed lasers could not be used without some penetration into the vestibule. Therefore there was concern that laser-induced shock waves could be introduced into the perilymph, increasing the danger to the inner ear beyond that of CW lasers. The Er:YSGG laser was calculated to require two to four times less total energy deposits versus the CO2 laser for the same laser defect. The erbium laser formed wellshaped, uniform round perforations close to those performed with CO2 superpulsed lasers153 and microprocessorcontrolled rotating mirror systems with CW CO2 lasers.154 Nagel155 proceeded to use the Er:YAG laser in 83 patients undergoing various types of ear operations, 32 of which were small fenestra stapedotomies. To make the fenestra, 3 to 8 pulses of 25 mJ were used to create a 0.4to 0.5-mm perforation. The crura were divided using 5 to 11 pulses of 25 mJ each, and the ligament was lysed with 5 to 10 pulses. The authors presented data including a histogram of a change in hearing loss that showed no specific pattern of loss at 4,000 or 8,000 Hz. A careful analysis of the data, however, showed that 8 of the 32 patients had a loss of hearing greater than 10 dB at 4,000 or 8,000 Hz, therefore meeting the 1995 American AcadLaryngoscope 110: May 2000

emy of OtolaryngologyHead and Neck Surgery (AAOHNS) criteria130 for hearing loss reporting of 33% significant hearing loss. Although the authors concluded that there was no significant incidence of hearing loss from the study, strict application of the reporting of hearing criteria demonstrates a significant high-frequency hearing loss observed in this series, and further studies would be recommended before further clinical trials.156 Thulium laser. Bottrill et al.157 examined a pulsed thulium (Tm:YAG [2.01- m]) laser for potential otological use. It was a flashlamp-pumped, solid-state laser using a chromium-sensitized Cr:YAG crystal doped with thulium ions and delivered through a quartz fiber. Fluences were 64 to 328 J/cm2 with 700-microsecond durations through a 300- m fiber. The Tm:YAG laser had many similar characteristics to the erbium laser but was less precise in cutting bone. It created little charring of bone but more than erbium and less than CO2. Again, the laser produced an audible acoustic shock that was of significant concern. On human cadaver stapes, a dry bone could actually ignite, creating a flame with plume that could have disastrous results intraoperatively, as well as a loud acoustic shock. The flame phenomenon never occurred in moistened bones, and the acoustic shock was somewhat attenuated. Using a vestibule model, temperature measurements were made, and with a closed footplate a rise of 2C was noted. If the footplate were opened, a rise of 11C was obtained. Further work was not pursued because of the loud shock wave and potential for flame. Diode lasers. There has been recent interest in the newer semiconductor diode lasers, which are fiber delivered, inexpensive, and available in CW or pulsed modes. However, the clinically available wavelengths between 800 and 1000 nm fall between hemoglobin and water absorption peaks. To date, they have been useful only for specifically pigmented tissues such as the ciliary body in the eye for glaucoma surgery. Early animal work with 810-nm diode lasers has found them capable of deep, extensive thermal damage similar to Nd:YAG lasers because of poor tissue absorption and therefore unpredictable amounts of reflection or deep absorption with scatter causing widespread thermal injury.158

Endoscopic-Assisted Laser Stapedotomy

Purpose of study. Recent advances in optical engineering have revolutionized the practice of medicine with the concept of minimally invasive diagnostic and surgical procedures. The specialty of otolaryngology head and neck surgery has been particularly enhanced by the incorporation of endoscopic visualization and surgical techniques using micro instrumentation and lasers for precise diagnostic or therapeutic effects. The most rapid developments have been in laryngeal, nasal, and sinus surgery. Endoscopic techniques have lagged far behind in otology because of the small size of the external auditory canal and the limited bony confines of the middle ear and temporal bone necessitating smaller optical devices than those required in other fields. Fiberoptic instruments have been introduced with suitably small diameters, but the resolution has been inadequate for anything other than gross anatomical observations. Rigid endoscopes, alPoe: Laser-Assisted Endoscopic Stapedectomy

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though larger in diameter, have much finer resolution and do yield images of sufficient clarity to make diagnostic and surgical procedures feasible. However, the larger diameter of these instruments has severely limited therapeutic options to date. More recent advances in optical technology have yielded fiberoptic bundles with higher resolution and glass rod endoscopes of smaller diameter, permitting instruments with working channels to be introduced into recesses of the temporal bone. Today endoscopes may be coupled with laser fibers to enjoy the same benefits of precise cutting, vaporization, and coagulation that have been enjoyed in the larynx and nose. New laser technology has produced low-cost, semiconductor diode, mid-IR CW lasers that are delivered through fiberoptics. These lasers promise a greater availability of affordable lasers that may have important roles in the development of minimally invasive otological procedures. Only near-IR wavelengths are currently available with power outputs suitable for clinical use. The purpose of this study was to investigate some of the newer fiberoptic and rigid endoscopic systems, as well as the latest diode laser systems currently available. It was chosen to evaluate these instruments in the context of laser stapedotomy procedures, since stapedotomy is among the most demanding and precise operations in otology. The laser has played a demonstrated role in small fenestra stapedotomy and, most recently, in a reintroduction of stapedotomy without prosthesis techniques. Performing the fine cuts necessary to isolate the anterior footplate in cases of limited anterior otosclerosis is feasible, but the technique is difficult. The use of an endoscope to make these cuts could provide a distinct advantage in improving the ease and precision of the laser burns on the anterior footplate and anterior crus. Improvement in techniques could result in expanding the candidate criteria for the procedure. Hopkins rod, fiberoptic, and gradient-index (GRIN) lens endoscopes were examined in cadaver temporal bones, animal operations, and patient surgery. Several new laser types in the mid-IR region were evaluated for lasertissue interactions. The near-IR, 812-nm diode laser was selected as a forerunner for future diode lasers, to perform stapes burns in guinea pigs. Contact laser probes that have never been tried in stapes surgery were evaluated making stapedotomy cuts in human cadaver temporal bones while recording from thermocouples placed in the vestibule. Histological examination of contact-tip probe burns on ossicles was performed. A clinical series of patients undergoing stapedotomy without prosthesis using the argon laser with endoscopic assistance is presented in this study.

and thulium CW (2.1- m) lasers. Each was evaluated in vitro for its effects on water, soft tissue, bone, and blood, and gross observations of the performance were made. The Ho:YAG (2.1- m) laser (Laser 12-3, Schwartz ElectroOptics, Orlando, FL) was a pulsed, solid-state system delivered through a 300- m-diameter quartz optical fiber. The output ranged from 0.3 to 1.5 J per pulse, pulse duration 250 microseconds, at a repetition rate of 1 to 15 Hz (pulses/second) with fluences up to 21.4 J/cm2. The diode (AlGaAs [808-nm] and InGaAsP [812-nm]) lasers (Endo Optiks, Little Silver, NJ) were CW, solid-state semiconductor devices delivered through quartz fibers 100 m in diameter, numerical aperture (NA) 0.22 or 0.37. They were evaluated with a free-standing fiber and with the fiber intrinsically incorporated into either a fiberoptic or GRIN endoscope bundled with the illumination and visualization fibers. The entire fiber probe was 0.9 mm in outside diameter (OD) including a 100- m laser fiber NA 0.37 bundled with a 10,000 (10k)-pixel optical endoscope 0.5 mm in diameter, as well as illumination fibers. The GRIN probe had an overall OD of 1.2 mm including a 200- m-diameter laser fiber NA 0.37 bundled with a GRIN lens 0.5 mm in diameter and illumination fibers. The probe was fitted with a coaxial aiming diode laser (630 nm) and were operated with outputs up to 0.9 W (measured) over a period of 0.1 to 0.5 seconds, yielding fluences of 11.5 to 57.3 J/cm2 for the free beam fibers. The InGaAsP diode laser was also evaluated with contact probes. The probes were 600- m-diameter fibers terminating with conical tips tapering to 300 or 100 m (Surgimedics, The Woodlands, TX) (Fig. 1) and flat tips with 400- m diameter (CeramOptec, East Longmeadow, MA). Contact laser power settings were the same as the free beam fiber settings. The diode GaAlAs (980-nm) laser (CeramOptec) was a semiconductor CW device equipped with a quartz fiber delivery using a 635-nm diode aiming beam. It was capable of outputs up to 50 W with pulse durations down to 0.1 seconds and was operated between 1 and 20 W on continuous mode. The Tm:YAG (2.1- m) laser (Maxios, Dublin, CA) was a diode-pumped CW device requiring a 208-V power source and water cooling. Outputs ranged up to 7.8 W (measured) using a 600- m-diameter fiber delivery with duration of 0.5 seconds. Fluences ranged from 3.5 to 10.5 J/cm2. Each of the lasers was evaluated for its gross interactions on water, fresh cadaver guinea pig or chicken muscle and bone, and fresh human blood, all at room temperature. Separate burns were made on each tissue type after painting it with indocyanine green

MATERIALS AND METHODS

Animals used in this study were albino guinea pigs of either sex, weighing between 350 and 500 g. Protocols were reviewed and approved by the Animal Care Committee at Massachusetts Eye and Ear Infirmary, and animals were humanely cared for at all times.

Laser Evaluations
The lasers that were evaluated for potential use in this study included holmium (2.1- m), diode (808-, 812-, and 980-nm), Fig. 1. Diode laser contact tips (original magnification 100- m tip; bottom, 300- m tip. 50). Top,

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(ICG) dye (Akorn, Inc., Decatur, IL). Subsequent in vitro and animal in vivo work was performed with the diode 812-nm laser using the free beam fibers and contact probes.

LaserTissue Interactions in Guinea Pig With Diode Contact Tip

Gross observations of tissue cutting and apparent thermal injury were made using the 300- m contact tip on a live guinea pig. It was initially anesthetized with sodium pentobarbital (intraperitoneally [IP], 10 mg/kg) and Innovar-Vet (intramuscularly [IM], 0.33 mL/kg). Tracheotomy was performed, and the head was secured in a rodent head holder with the body prone. The animals body temperature was maintained by thermostatic control of the operating chamber ambient air. A new, clean contact probe was burned into soft tissue several times until reproducible burns occurred, then fixed in position with a clamp, bringing it into contact with the subject tissues under just sufficient tension to slightly indent the tissue or hold it against bone without moving. The laser was then fired at power settings ranging from 0.5 to 0.9 W (measured) for pulse durations varying from 0.1 to 0.5 seconds (0.05 0.45 J) and repeated with the wound submerged in saline 1 cm deep, holding a plastic open-ended cylinder over the tissue to retain the saline. Tissues exposed included temporalis muscle and fascia, skin of the pinna, and calvarial bone. Gross observations are noted in this report. Specimens were harvested, placed in 10% formalin, then processed into thin sections and stained with H&E, and will be the subject of a subsequent report. The 812-nm diode laser was then used on formalinpreserved human ossicles employing the 100- and 300- m contact probes (Fig. 4). Both fibers were burned into soft tissues until reproducible laser burns occurred. Exposures of 1.0 W (power setting) varying from 0.1 to 0.5 seconds (0.1 0.5 J) were made on two stapes, four incudi, and two malleoli. Specimens were placed in 10% formalin, then processed into thin sections and stained with H&E. One stapes was lost in processing. The remaining ossicles were studied under the light microscope for depth and width of vaporization craters and adjacent thermal injury.

Fig. 2. Operative diagram. Segment of stapes anterior crus is lysed by laser exposure.

Endoscopic 812-nm Diode Laser Stapedioplasty With Measurement of Vestibular Thermal Effects in Human Temporal Bones
Stapes footplate fenestrations were made under endoscopic guidance in 10 human cadaver temporal bones using the 812-nm diode laser delivered with 300- and 100- m contact tips while temperature measurements were made within the vestibule. Potential endoscopes to be used in the study were evaluated in the middle ears of a cadaver and live guinea pig and a human formalin-preserved temporal bone. These were inspected with Hopkins rod, 1.9-mm OD, 0- and 30-degree-view-angle endoscopes (Karl Storz, Culver City, CA), then the10k pixel, 0.9 mm OD fiberoptic endoscope (Endo Optiks, Little Silver, NJ) and the GRIN (0.5-mm lens in an overall package of 1.2 mm OD) endoscope (Endo Optiks). The size, ease of use, and optical imaging qualities were compared. Images were presented on a Sony Triniton 13-inch color video monitor (PVM-1353MD, Sony Corp., Tokyo, Japan). The Hopkins rod endoscopes were fitted with a Telecam head-C video camera head and Dx-cam processor (Karl Storz). The fiberoptic scope used an internal camera in the laser endoscope unit (Uram E2, EndoOptiks, Little Silver, NJ). The GRIN lens was fitted with a video camera using an Elmo processor (Elmo Corp., Tokyo, Japan). The GRIN endoscope was used for imaging in the subsequent human cadaver stapedioplasties. Temperatures were recorded with a microprocessor digital thermometer (Omega Engineering, Inc., Stamford, CT) fitted with a 0.2-mm-diameter, fiber-coated, silver-colored type K thermocouple, which was placed into the vestibule through a laby-

rinthotomy drilled through the horizontal semicircular canal or promontory or from a middle fossa approach opening the medial wall of the vestibule. The thermocouple was secured within 2 mm of the stapes footplate and with the tip centered deep to it, as estimated by the silhouette seen through the footplate. The labyrinth was filled with room-temperature normal saline until the saline level could be seen against the footplate and the labyrinth sealed with bone wax. If a loss of saline occurred, the bone wax seal was opened and saline replaced. The saline level was observed before each laser irradiation to ensure that it was stable and would not drop during the exposure. Under an operating microscope, the 300- m contact tip was first used in a temporal bone specimen with the incus and stapes previously removed to determine the optimal power settings and evaluate the thermocouple performance. A thermocouple was placed into the open vestibule through a labyrinthectomy approach, and the vestibule filled with saline as described above. Power settings on the laser were 1.0 W and 0.5 and 0.2 seconds (0.5 and 0.2 J) using a clean, fresh tip. Ten laser exposures spaced

Fig. 3. Operative diagram. Right-angled pick confirming complete separation of the anterior crus.

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2 seconds apart were made along the rim of the oval window to simulate the maximum number of burns that would be expected for most laser fenestrations in a typical stapedotomy, while taking temperature measurements at baseline at the end of the 10 burns and every 5 seconds until temperature returned to baseline. The contact fiber tip was then burned-in, placing it in contact with soft tissue in the specimen and repeatedly firing the laser until a char stuck onto the tip. The laser exposures were repeated, and new temperature measurements made. Once a consistent laser tissue effect was obtained, further trials were made with the now burned-in fiber. Endoscopic stapedotomies were performed using the GRIN lens endoscope held in the left (nondominant) hand and holding the contact tip fiber in the right hand while recording temperature measurements. The 300- m contact tip was first used on 10 consecutive temporal bone specimens with intact stapes, working through the bony ear canal. The entire stapes footplate was inspected endoscopically, and curettage of the scutum was not necessary. The anterior crus was divided using the contact probe with laser settings of 1.0 W and 0.2 seconds. (0.2 J/pulse) performed under direct endoscopic guidance. The thermocouple was secured, and the labyrinth filled with saline as described above. Visualizing the stapes footplate endoscopically, 10 laser burns with settings of 1.0 W and 0.2 seconds spaced 2 seconds apart were made in adjacent straight lines across the junction of the anterior and middle third of each footplate. Overlapping of the burns was minimized. Measurements of temperature were made at baseline, immediately after the 10 laser burns, then at 5-second-intervals until the temperature returned to baseline. The procedure was performed on 10 separate temporal bone specimens. The 100- m contact probe was used on five of the previous temporal bones for similar measurements. The probe was initially adequately burned-in, then under endoscopic guidance the procedures were identically repeated except that a new cut was made into the anterior crus and the footplate was divided across the junction between the posterior and middle thirds.

Clinical Endoscopic-Assisted Argon Laser Stapedotomy Without Prosthesis (Stapedioplasty)

Thirty-four consecutive patients underwent primary surgery by the author for otosclerosis between December 6, 1996, and February 25, 1998, and were studied prospectively. Eleven of these patients (32%) underwent a laser stapedioplasty without prosthesis. Patients were given the option of conventional stapedotomy with prosthesis versus stapedioplasty, and informed consent was obtained. Each patient understood that it was uncertain whether stapedioplasty were possible and that a conventional procedure may be performed. They understood that there were no data available regarding the potential long-term success of the stapedioplasty. All 34 patients planned for primary otosclerosis surgery, and the decision to perform the procedure with or without a prosthesis was made intraoperatively. The 23 patients (68%) who had conventional stapedotomies were followed as a control group.

Surgical Technique
Eight of the patients underwent general anesthesia, and three had local anesthesia with intravenous sedation. Lidocaine 1% with 1:100,000 epinephrine injection was made in all cases into the external auditory meatus and posterior tragus. Tragal perichondrium was first harvested for sealing of the oval window. Under the operating microscope, a tympanomeatal flap was elevated, working through the external auditory canal and using a speculum holder. Standard curettage of the scutum was performed until the entire footplate, pyramidal eminence, and facial nerve were visible, and the chorda tympani nerve was preserved in all cases. The ossicles were palpated to confirm that the stapes was fixed. The oval window was inspected for the degree of otosclerosis. If the otosclerotic focus appeared limited to the anterior third of the footplate, a stapedioplasty was attempted. A prototype argon laser endoscope (Endo Optiks) was designed to specifications of the author and employed for the first four patients. The endoscope was the same as the 10k fiberoptic imaging and laser bundle used in the guinea pig study just described, but fitted with a 200- m diameter argon laser fiber protruding from the endoscopes distal tip a distance of 3 mm. The imaging was performed with an Elmo camera and processor and a Sony 17inch video monitor. The laser fiber was coupled to the argon laser (HGM, Salt Lake City, UT). Fog-Away antifog solution (Technol Medical Products, Inc, Fort Worth, TX) was applied to the endoscope tip. The laser endoscope was introduced into the field, removing the microscope and viewing the field from the monitor. Lysis of a segment of the anterior crus was performed with laser power settings of 2.0 W and 0.2 seconds using the laser in near contact with the bone (Fig. 2). Division of the crus was confirmed visually or by palpation with a right- angled pick (Fig. 3). The laser setting was then reduced to 1.5 W and 0.2 seconds for the stapes footplate. The laser was used to make a row of burns on the footplate, to separate it at the junction between the anterior and middle thirds. Smoke was evacuated during the laser exposures with a 24-gauge suction held in the authors nondominant (left) hand. The burns overlapped sufficiently to create a gap approximately one burn wide (0.2 mm) and required between 6 and 10 exposures (Fig. 4). Once the footplate division appeared complete, the posterior crus was palpated with the protruding laser fiber to ensure that the posterior footplate was mobile. The endoscope was removed, and the microscope returned. Unrestricted mobility of the posterior footplate was confirmed by palpating the posterior crus with a straight pick (Fig. 5); then the footplate was covered with small pieces of perichondrium (Fig. 6), and the flap was closed. Patients with obvious larger plaques of otosclerosis fixing more than the anterior third of the footplate, or who had anatomy

Fig. 4. Operative diagram. Row of laser burns made across stapes footplate to completely separate the anterior one third from the posterior two thirds of the footplate. The cut is made posterior to the otosclerotic focus, not through the otosclerosis.

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compared using the paired Student t test with P value less than .05 used for a level of significance.

RESULTS Observations of LaserTissue Interactions

Holmium laser. The pulsed Ho:YAG (2.1- m) laser was characterized by a loud, explosive impact onto all samples. The acoustic shock was an audible pop that raised concerns about potential hearing injury if used in the ear. The shock was apparent in water, blood, and fresh chicken breast. Impact on bone produced a more dramatic explosion, which could include a transient flame if a dry charred area were hit. Considerable splatter of tissue and fluid debris resulted from the impacts. The magnitude of the acoustic shock and degree of explosive force that resulted from energy levels necessary to cut bone were not compatible with the precise requirements of otological surgery. Diode lasers. The performance of the two diode AlGaAs (808-nm) and InGaAsP (812-nm) lasers was nearly identical, and no differences in tissue interactions were observed between them. There was no difference in the tissue interactions between the free fiber and the endoscope bundled laser fiber. Measured power outputs were identical for both fibers. Using exposures of 0.9 W (measured), 0.1 to 0.5 seconds, no effect was seen on water, fresh human blood, or light-colored muscle in fresh cadaver guinea pigs. Darker muscle did absorb some energy, showing a small area of thermal injury with water vaporization, slight contraction of the impacted area, but no tissue vaporization. Dark dried blood or coagulated blood within vessels absorbed sufficient energy to produce favorable tissue vaporization effects. Light-colored bone had no effect, but dark or bloodstained bone absorbed the energy well and showed favorable punctate vaporizations with minimal surrounding thermal injury zone. If a poorly absorbing tissue underwent repeated laser exposure to produce a small dark char, the char immediately absorbed the energy, produc-

Fig. 5. Operative diagram. Mobility of the stapes posterior segment is tested by palpation with a straight pick.

that prevented safe performance of the stapedioplasty technique, underwent a conventional stapedotomy with an argon laser rosette in the center of the footplate or drill-out if necessary and insertion of a prosthesis. The stapedius tendon and posterior crus were lysed with a standard laser fiber (CeramOptic Endoprobe EP-20, HGM); then additional laser burns were made to create a central rosette generally in continuity with the first row of burns. The char was removed with oval window picks or rasps, and a Schuknecht fluoroplastic piston 0.6 mm in diameter (Smith & Nephew, Inc., Memphis, TN) was placed through the fenestra. Small pieces of perichondrium were placed around the prosthesis and covered the footplate. The flap was closed. Attempted stapedioplasty in patients in whom the footplate could not be adequately mobilized was converted to a conventional stapedotomy using the above techniques. The footplate laser burns were merely expanded to form a central rosette to accommodate the prosthesis. The prototype laser endoscope was not available for the remaining six patients, who had the stapedioplasty performed under the operating microscope with a standard laser fiber. The fiber tip required a slight bend (performed by hand) to pass it inferiorly to the stapes and contact the anterior crus, placed either under direct vision or by palpating the crus with the fiber. A segment of the anterior crus was lysed. Complete separation of the crus was confirmed by passing a right-angled pick through the defect and by visual inspection through a 1.9-mm-OD 30degree Hopkins rod endoscope (Karl Storz) looking through the eyepiece of the endoscope or using an Elmo camera and Sony monitor. Laser lysis of the crus under direct endoscopic visualization was possible but was difficult because of the relatively large endoscope diameter. The footplate burns were made as previously described under the operating microscope, and some of the burns either at the superior or inferior oval window rim were performed without direct visualization because of obscuration by the remaining stapes superstructure. The entire footplate could be visualized endoscopically, but simultaneous laser surgery with the endoscope in place was impractical. The procedure was completed as described above. Hearing results were reported in accordance with the recommendations of the AAO-HNS 1995 Committee on Hearing and Equilibrium.130 The pure-tone averages for air and bone conduction were calculated as the mean of the 500-, 1,000-, 2,000-, and 3000-Hz frequencies. Preoperative and postoperative data were

Fig. 6. Operative diagram. Strips of perichondrium have been placed over the footplate to seal the vestibule.

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ing a favorable vaporization cavity. Similarly, tissues painted with ICG dye to enhance absorption showed good burns with little adjacent thermal injury. The depth of penetration was limited unless some degree of char resulted from the initial burn of the ICG. The ICG did not uniformly coat the tissue, and thinly dyed areas could permit burning off the ICG, causing only superficial thermal injury to the underlying tissue without vaporization or char to aid with subsequent burns. The improved absorption with ICG produced a more vigorous vaporization in tissue resulting in spatter that contaminated the endoscope lens and laser fiber tip. Additional laser use without removal of the debris would damage the fiber tip and reduce power. Continuous-mode laser applications at 0.9 W (measured) on poorly absorbing tissues produced slow, diffuse heating of the water content. When sufficient water had evaporated, wide charring and incandescence developed. In one case the laser was exposed to a guinea pig stapes in situ. There was little appreciable effect for several seconds, then it suddenly and uncontrollably charred the entire superstructure. Using 15-W continuous mode produced an acceleration of the same process with a wider and deeper region of char and burning. It was possible to more quickly induce a char in poorly absorbing tissues, but the depth and width of the burn were difficult to control. Diode InGaAsP (812-nm) laser with contact probes. With the diode InGaAsP (812-nm) laser, contact fibers had good handling characteristics and were easy to use in conjunction with a handheld endoscope if desired. Flat-tipped, 400- m probes produced a wide field of heating that was difficult to control. There was no difference in tissue effects with degree of pigmentation. At settings of 1 to 4 W on continuous mode, both bone and soft tissue had a radially widening field of coagulation followed by central burning and charring. At 5 W, bone cutting could occur but produced a 1-mm-wide thermal injury zone with charring. When the tissue and probes were submerged in water, minimal tissue effects occurred and the probe was seen to slowly heat the water bath. The conical tip (300 m) had much better tissue interactions than the flat tip and was much more controllable and predictable. Burns were very favorable with sharp vaporization margins and minimal adjacent thermal injury. There was a reduction in absorption of energy in nonpigmented tissues that was overcome by burningin the tip with repeated applications in soft tissue or blood or by painting ICG on the tip. Tissue splatter onto the probe was inconsequential, since its optical qualities were insignificant. Bone-cutting of the ossicles was favorable but produced a wider zone of thermal injury than desired. The tissue and probe were submerged in a water bath and tissue vaporization was still possible with a trace of bubbling seen at the tip and no visible adjacent thermal injury at settings of 1.0 W and 0.5 to 1.0 seconds. The 300- m tip was used on temporalis muscle and fascia, cranial bone, and skin of the pinna in a live anesthetized guinea pig. Soft tissues had slightly less pigmentation than the cadaver preps, and there was a more noticeable problem with heating of nonpigmented tissues. Laryngoscope 110: May 2000

A more thorough burn-in was required for reliable functioning of the tip. A matrix of burns was performed varying the exposures from 0.5 to 1.0 W over a period of 0.1 to 0.5 seconds, then repeated with the tissue submerged in a saline-filled cylinder. Burns with exposures of 0.5 W and 0.1 second were minimal, and with exposures of 1.0 W with 0.5 seconds, much larger and deeper with a wider zone of adjacent injury. There was a linear expansion of the crater and adjacent thermal injury radius with increasing power or time of exposure. Saline-submerged tissue burns were markedly reduced in depth and width with a much smaller thermal injury zone. Burns on skin and muscle or fascia were very similar. Bone burns produced more significant charring within the crater and a wider zone of thermal injury than with soft tissue. The 100- m conical tips had more precise burn and cutting properties than the 300- m tips. The tip was even less effective on nonpigmented tissues than the 300- m tip and required a thorough burn-in to work on wet white bone. The bone and tissue vaporization was very precise with tight margins of adjacent thermal injury. Cutting and vaporization on submerged tissues were less effective than with the 300- m tip. The 300- and 100- m tips were used on human formalin-preserved ossicles. The 300- m fiber burns were wider with a larger zone of adjacent thermal injury than the 100- m fiber burns. The stapes footplate cuts with the 100- m fiber were very precise, and adjacent thermal

Fig. 7. Formalin-preserved human stapes with linear burn made across footplate using 100- m contact tip with 812-nm diode laser power setting of 1.0 W for 0.2 seconds (original magnification 30).

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TABLE I. Dimensions of Contact Laser Tip Burns on Human Ossicles.

Duration (secs) Depth ( m) Width ( m) Injury ( m)

100 m (n 0.5

3 ossicles) 320 345 380 205 240 140 125 120 85 3 ossicles) 485 440 420 340 405 245 180 145 300 280 240 165 180 165 280 65 85 160 95 74 83 47 55 62 4 38 9 185 120 245 85 60 120 60 35 30 62 41 40 8 18 7 4 6 1

0.2

0.1

300 m (n 0.5 Fig. 8. Formalin-preserved human malleus manubrium exposed to 300- m contact tip with 812-nm diode laser power settings of 1.0 W for 0.1 seconds (left burn), 0.2 seconds (middle burn), and 0.5 seconds (right burn) (original magnification 50).

0.2

injury appeared minimal. Histopathological appearance is demonstrated in Figures 7 to 9. Results are presented in Table I and in Figures 10 to 12. Diode GaAlAs (980-nm) laser. With the diode GaAlAs (980-nm) laser the tissue interactions were grossly indistinguishable from the 808- and 812-nm lasers. Absorption in water, nonpigmented tissues, and fresh blood was poor and improved with pigmentation added, dried blood, or painting with ICG. Operation at 20 W and continuous mode produced deep water vaporization until charring began, followed by extensive burning with a wide margin of thermal injury. Thulium laser. With the Tm:YAG (2.1- m) continuouswave laser, exposure to water produced rapid boiling at the surface of the water throughout the exposure. Irradiation of fresh human blood produced rapid boiling of the water content superficially followed by charring of the surface, then

0.1

deeper vaporization through the char. On cadaver guinea pig temporalis muscle, settings of 2 W (measured), 0.5 seconds, produced only superficial thermal injury with vaporization only of water. Settings of 4 W (measured) produced a favorable, precise burn with a narrow rim of thermal injury. Settings of 5, 6, and 7.5 W (measured) had increasingly deep, sharp-walled vaporization craters but a wider margin of thermal injury than at 4 W. The effects on bone were similar with the optimal crater and minimal adjacent thermal injury found with the 4-W exposure. Bone burns showed a tight crater formation with central charring that appeared very favorable for ossicular work. There was no significant audible acoustic shock. The prototype laser became disabled and could not be used at that time for further study.

Fig. 9. Formalin-preserved human malleus manubrium exposed to 100- m contact tip with 812-nm diode laser power settings of 1.0 W for 0.1 seconds (left burn), 0.2 seconds (middle burn), and 0.5 seconds (right burn) (original magnification 50).

Fig. 10. Median depths of craters created on human formalinpreserved ossicles with 812-nm contact tip diode laser delivering 1.0 W. Medians are calculated from data in Table I.

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sorption of the energy on the footplate area and a wide range of vestibule temperature elevations, as extreme as 50.7C in one instance. Once the tip was coated with char, it performed very reproducibly. The 300- m probes had a larger excursion of temperatures than the 100- m probes. The quality of the burns with the 100- m probes was very clean with minimal char and tight, round craters. Temperature elevations with 10 serial burns using the 100- m probes yielded an average rise of 3.25C and a maximum rise during the trials of 4.30C, which are considered clinically acceptable. Complete data are presented in Tables II and III and summarized in Figures 13 and 14.
Fig. 11. Median widths of craters created on human formalpreserved ossicles with 812-nm contact tip diode laser delivering 1.0 W. Medians are calculated from data in Table I.

Clinical Endoscopic-Assisted Argon Laser Stapedotomy Without Prosthesis (Stapedioplasty)

Thirty-four patients underwent primary otosclerosis operations in the study period. Eleven patients (32.4%) had a stapedioplasty procedure, and the remaining 23 (67.6%) had a conventional small fenestra stapedotomy. In the stapedioplasty group ages ranged from 32 to 55 years with a mean of 42.5 years. There were seven women and four men, 7 left ears and 4 right. In the stapedotomy group ages ranged from 21 to 79 years with a mean of 45.0 years. There were 14 women and 9 men, 12 left ears and 11 right. Each case was examined to determine whether a stapedioplasty should be attempted. The decision was based on adequate exposure of the footplate to make the cuts and extent of otosclerotic involvement. Stapedioplasty was attempted on 13 patients, but two cases were converted to conventional stapedotomy when the footplate could not be adequately mobilized. The intraoperative findings and the reasons stapedioplasty could not be performed in the 23 stapedotomy patients are summarized in Table IV. Nine of the patients (39%) required a microdrill fenestra because of extensive otosclerosis. Complete audiometric data for patients are presented in Tables V through X. The stapedotomy and stapedioplasty groups contained very similar distributions of hearing losses, with the mean preoperative air-bone gap for stapedioplasty of 26.6 dB (SD 7.30) and for stapedotomy, 27.6 dB (SD 8.84). The postoperative results were statistically similar with mean air-bone gap for

Endoscopic 812-nm Diode Laser Stapedioplasty With Measurement of Vestibule Thermal Effects in Human Temporal Bones
Contact tip probes were used to perform the footplate stapedioplasty cuts while separately hand-holding the GRIN endoscope for visualization. No curettage of the scutum was necessary in any of the 10 human temporal bone specimens, and each procedure was performed through the external canal. The endoscopic view was reasonably wide in field and compared favorably to rigid rod multi-element endoscopes and to a surgical microscopic view. There was slight noticeable loss of resolution and a definite reduction in brightness compared with Hopkins rod scopes. Adequate visualization of both stapes crura and the entire footplate was obtained in each case with the endoscopic view. The laser probe was generally passed from the inferior aspect through the crura. It was often awkward to maneuver the probe up to the superior rim of the footplate through the crura and would have been easier with an angled probe. When possible, the superiormost burns were made passing the laser superior to the superstructure. The contact probes required a thorough burn-in procedure before yielding reproducible burns. Before burn-in, probes used on a practice specimen showed variable ab-

TABLE II. Vestibule Temperatures After 10 Exposures With 300- m Contact Laser Probe.
Time (s) Mean 300 m (degrees C) Median 300 m (degrees C) SD 300 m

Fig. 12. Median zones of thermal injury surrounding craters created on human formalin-preserved ossicles with 812-nm contact tip diode laser delivering 1.0 W. Medians are calculated from data in Table I.

0 5 10 15 20 25 30 35 40

6.82 3.58 2.55 1.90 1.45 1.15 0.93 0.77 0.67

5.65 3.65 2.60 1.90 1.40 1.10 0.85 0.70 0.60

3.47 1.52 1.15 0.87 0.65 0.52 0.41 0.35 0.28

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TABLE III. Vestibule Temperatures After 10 Exposures With 100- m Contact Laser Probe.
Time (s) Mean 100 m (degrees C) Median 100 m (degrees C) SD 100 m

0 5 10 15 20 25 30 35 40

3.24 2.62 2.14 1.74 1.46 1.18 0.98 0.86 0.72

3.60 3.00 2.40 1.90 1.60 1.20 1.00 0.90 0.70

0.94 0.68 0.49 0.38 0.34 0.29 0.29 0.27 0.27

Fig. 13. Time decay curve of thermocouple measurements in vestibules of human temporal bones subjected to laser exposure of the footplate with 10 burns separated by 2 seconds each, using the 300- m 812-nm contact tip diode laser delivering 1.0 W at 0.2 seconds. Graph shows range of temperatures recorded and plots mean values.

stapedioplasty of 8.3 dB (SD 9.8) and for stapedotomy, 4.9 dB (SD 3.77) at 6 weeks after surgery. P values for improvement based on the operation were P .0002 for stapedioplasty and P .0001 for stapedotomy at 6 weeks. The stapedioplasty results more than 6 months after surgery includeda mean air-bone gap of 10.8 dB (SD 9.40), which was not significantly different from the 6-week results (P .59). There was no correlation between severity of air-bone gap and ability to perform stapedioplasty.

There were no predictive factors noted on regression analysis. There was a single patient (patient 2) in the stapedioplasty group who failed to improve postoperatively. This patient had otosclerosis involving more than the anterior one-third of the footplate, and the laser division of the footplate was made closer to the middle of the footplate. It was thought that adequate mobilization of the posterior segment had been achieved. Patient 8 on an early postoperative audiogram failed to adequately close

TABLE IV. Intraoperative Findings During Stapedotomy.

Patient No. Footplate Drillout Attempted Stapedioplasty

Comments

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23

Otosclerosis involving both crura Y Y Y Y Y Y Y Large plaque otosclerosis Narrow oval window & low VII nerve Y Small oval window niche Large plaque otosclerosis Large plaque otosclerosis Large plaque otosclerosis Y Narrow oval window Crura fixed to promontory Large plaque otosclerosis Y Y Stapes footplate not mobilized Large plaque otosclerosis Stapes footplate not mobilized Crura fixed to promontory

Fig. 14. Time decay curve of thermocouple measurements in vestibules of human temporal bones subjected to laser exposure of the footplate with 10 burns separated by 2 seconds each, using the 100- m 812-nm contact tip diode laser delivering 1.0 W at 0.2 seconds. Graph shows range of temperatures recorded and plots mean values.

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TABLE V. Preoperative Audiometric Data for Patients Undergoing Stapedioplasty.

Pure Tones (Air) Patient No. Age (y) Sex Ear 500 1000 2000 3000 4000 8000 PTA* (air) dB 500 1000 Pure Tones (Bone) 2000 3000 4000 PTA* (bone) dB ABG (dB) SDS (%)

1 2 3 4 5 6 7 8 9 10 11

43 41 55 37 39 53 42 43 34 32 48

M M M F F F M F F F F

R L L L R L R L L L R

45 65 55 70 60 70 45 50 50 60 65

50 60 45 60 55 65 45 45 50 50 60

40 45 30 60 40 60 40 35 60 40 50

40 NA 50 50 45 65 50 25 75 35 60

45 40 50 65 40 75 55 30 80 40 55

60 65 75 65 50 90 75 45 95 40 50

43.7 53.1 45 60 50 57.5 45 38.8 58.8 46.3 58.8 Av 50.6 SD 7.04

15 20 10 20 15 30 10 15 20 25 15

20 20 15 15 20 35 15 25 20 15 15

30 25 30 25 30 55 35 20 45 20 25

25 NA 35 20 25 45 35 10 50 15 20

30 20 30 20 15 40 40 15 50 15 20

22.5 23.1 22.5 20 22.5 41.3 23.8 17.5 33.8 18.8 18.8 Av 24.1 SD 6.84

21.2 100 30 96 22.5 100 40 100 27.5 100 16.2 92 21.2 100 21.3 100 25 100 27.5 100 40 98 Av 26.6 Av 98.7 SD 7.30 SD 2.45

*PTA and air-bone gap based on four-tone average of 500, 1000, 2000, and 3000 Hz (or mean of 2k or 4k if NA). NA not available; Av average; ABG air-bone gap; SDS speech discrimination score; PTA pure-tone average.

the air-bone gap, but she had a severe upper respiratory tract infection at the time, and a middle ear effusion. Subsequent testing demonstrated closure of the gap. There was no significant worsening of the stapedioplasty results during 6 months of follow-up. The stapedotomy group had one patient (patient 12) who failed to close the air-bone gap within 10 dB, and the hearing at 8 kHz decreased, but he was tested only 3 weeks after surgery and subsequent audiograms were not available. The two patients who had stapedioplasty attempts converted to stapedotomy had successful outcomes without complications. There were no complications in either the stapedioplasty or stapedotomy group. The chorda tympani was

preserved in all cases. There was no incidence of significant sensorineural hearing loss or significant change in speech discrimination (word recognition) as defined by the 1995 AAO-HNS committee.130

DISCUSSION
New lasers, laser delivery systems, and endoscopic techniques were investigated to determine whether these emerging technologies could facilitate the techniques required for stapedotomy without a prosthesis (stapedioplasty). Preservation of as much of the native stapes as possible is conceptually appealing but may also have substantial benefits for patients. The most common complications occurring after stapedotomy involve the prosthe-

TABLE VI. Six-Week Postoperative Audiometric Data After Stapedioplasty.

Pure Tones (Air) Patient No. Pure Tones (Bone) ABG* (dB) Improvement in ABG (dB) SDS (%)

Surgery Date 500 1000 2000 3000 4000 8000 PTA* (Air) dB 500 1000 2000 3000 4000 PTA* (Bone) dB

1 2 3 4 5 6 7 8 9 10 11

12/6/96 1/15/97 1/29/97 2/19/97 6/6/97 8/1/97 8/6/97 9/8/97 2/11/98 2/25/98 3/2/98

25 60 30 20 30 45 20 55 20 35 40

20 60 15 20 20 45 20 45 15 30 35

20 45 15 20 15 40 25 30 35 10 20

35 40 35 NA NA 45 40 15 40 20 30

25 50 30 15 30 55 50 25 70 10 30

55 60 45 30 40 90 60 45 90 25 40

25 51.2 23.7 19.4 21.9 43.8 26.3 36.3 27.5 23.8 28.8 Av 29.8 SD 9.91

15 20 20 20 15 30 10 10 20 30 20

15 15 15 20 15 35 15 10 20 20 15

20 25 25 15 15 50 20 20 25 10 20

35 20 35 NA NA 45 30 15 45 10 20

25 20 30 15 30 40 40 20 50 5 25

21.2 20 23.7 17.5 16.8 40 18.8 13.8 27.5 17.5 18.8 Av 21.4 SD 7.16

3.8 31.2 0 1.9 5.1 3.8 7.5 22.5 0 6.3 10 Av 8.3 SD 9.8

17.4 1.2 22.5 38.1 22.4 12.4 13.7 1.2 25 21.2 30 Av 18.2 SD 11.9

96 96 100 100 100 96 100 100 100 96 100 Av 98.5 SD 2.02

*PTA and air-bone gap based on four-tone average of 500, 1000, 2000, and 3000 Hz (or mean of 2 k and 4 k if NA).

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TABLE VII. Six-Month or Greater Postoperative Audiometric Data After Stapedioplasty.

Pure Tones (Air) Patient No. Pure Tones (Bone) PTA* (Bone) dB ABG* (dB) Improvement in ABG (dB) SDS (%)

F/U (mo) 500 1000 2000 3000 4000 8000 PTA* (Air) dB 500 1000 2000 3000 4000

1 2 3 4 5 6 7 8

15 17 16 14 12 10 9 8

30 65 25 25 40 35 15 30

25 60 20 25 25 30 15 25

25 45 15 15 20 40 20 15

40 45 30 10 NA NA 25 15

30 55 20 20 20 40 30 10

50 70 40 25 40 65 35 30

30 53.8 22.5 18.7 26.3 36.3 18.8 21.3 Av 28.5 SD 11.87

15 25 15 20 0 20 10 5

15 20 15 20 10 25 15 10

25 25 15 15 20 30 20 15

35 20 30 NA NA NA 25 15

25 25 20 15 15 30 30 10

22.5 22.5 11.8 17.5 11.9 26.3 17.5 11.3 Av 17.7 SD 5.73

7.5 31.3 10.7 1.2 14.4 10 1.3 10 Av 10.8 SD 9.4

13.7 96 1.3 96 11.8 96 38.8 100 13.1 92 11.2 100 19.9 100 11.3 100 Av 14.8 Av 98.0 SD 11.34 SD 2.98

*PTA and air-bone gap based on four-tone average of 500, 1000, 2000, and 3000 Hz (or mean of 2 k and 4 k if NA). F/U follow-up.

sis.159 Eliminating the prosthesis which must protrude into the inner ear makes the procedure less invasive and may reduce risks of granulation, infection, vertigo, and sensorineural hearing loss. Incus necrosis and slipped prosthesis problems would be eliminated. Preservation of

the stapedius tendon may improve word recognition in background noise and reduce hyperacusis,115 and preservation of the annular ring may improve protection from loud noise exposure compared with procedures with a prosthesis. Longer-term studies with larger numbers of

TABLE VIII. Preoperative Audiometric Data for Patients Undergoing Stapedotomy.

Pure Tones (Air) Patient No. Age (y) Sex Ear 500 1000 2000 3000 4000 8000 PTA* (Air) dB 500 1000 Pure Tones (Bone) 2000 3000 4000 PTA* (Bone) dB ABG (dB) SDS (%)

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23

45 61 45 66 30 49 52 40 43 21 50 79 48 37 34 64 39 35 40 41 48 46 23

M F M M M F M F F F M M M F F F F F F F F M F

R R R L L R L R L L R R R R R L L L L L L L R

60 70 55 50 50 55 35 60 65 35 60 80 85 55 55 95 55 55 65 70 60 45 55

55 55 50 55 45 55 40 60 60 30 60 75 80 55 60 80 50 55 60 65 40 40 50

40 70 55 75 40 55 55 50 55 30 50 60 60 65 45 55 45 40 65 50 25 20 40

NA 60 35 75 NA 50 70 50 NA NA 75 80 50 70 NA 50 45 45 NA 45 NA NA 40

25 70 35 80 45 50 70 45 45 10 85 65 65 75 40 75 30 45 105 60 40 25 30

40 75 35 70 35 50 65 60 35 25 90 100 75 80 45 95 60 45 110 70 55 20 40

46.9 63.8 48.8 63.8 44.4 53.8 50 55 57.5 28.8 61.3 73.8 68.8 61.3 50.6 70 48.8 48.8 68.8 57.5 39.4 31.9 46.3 Av 53.9 SD 11.8

25 30 15 15 20 15 25 15 10 10 25 15 35 30 25 40 20 10 25 30 20 10 10

15 20 25 15 10 15 20 15 20 15 25 15 30 20 25 35 20 25 25 25 25 10 5

20 45 45 60 35 35 55 30 15 20 35 20 45 45 35 35 30 20 55 30 25 20 15

NA 35 20 60 NA 30 50 20 NA NA 40 45 35 50 NA 40 30 20 NA 25 NA NA 10

15 45 25 55 30 30 65 15 15 10 40 40 30 50 15 45 25 15 65 30 25 10 10

19.4 32.5 26.3 37.5 24.4 23.8 37.5 20 15 15 31.3 23.8 36.3 36.3 27.5 37.5 25 18.8 41.3 27.5 23.8 13.8 10 Av 26.3 SD 8.82

27.5 100 31.3 92 22.5 100 26.3 100 20 100 30 100 12.5 92 35 96 42.5 100 13.8 100 30 100 50 88 32.5 100 25 100 23.1 100 32.5 96 23.8 96 30 100 27.5 92 30 96 15.6 100 18.1 100 36.3 100 Av 27. Av 97.7 SD 8.84 SD 3.58

*PTA and air-bone gap based on four-tone average of 500, 1000, 2000, and 3000 Hz (or mean of 2 k and 4 k if NA).

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TABLE IX. Six-Week Postoperative Audiometric Data After Stapedotomy.

Pure Tones (Air) Patient No. Surgery Date Pure Tones (Bone) ABG* (dB) Improvement in ABG (dB) SDS (%)

500 1000 2000 3000 4000 8000 PTA* (Air) dB 500 1000 2000 3000 4000 PTA* (Bone) dB

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23

12/30/96 1/15/97 3/3/97 3/12/97 3/26/97 4/28/97 5/5/97 5/7/97 6/9/97 6/9/97 7/21/97 7/28/97 7/28/97 7/30/97 8/6/97 8/8/97 8/18/97 10/1/97 10/17/97 12/3/97 12/5/97 2/20/98 2/20/98

35 30 30 20 25 25 15 25 25 15 20 45 55 30 20 35 20 30 20 25 30 15 25

25 25 30 25 20 20 20 25 30 15 15 25 40 20 15 25 15 25 20 20 10 10 20

25 45 30 35 30 25 35 25 20 10 20 30 30 35 10 5 10 15 35 20 10 15 15

30 45 20 40 35 25 45 20 15 5 35 60 30 35 10 15 NA 10 NA 20 25 NA 15

35 50 30 45 50 30 60 15 30 15 40 75 40 40 15 35 20 20 70 30 45 30 15

50 55 50 55 50 40 90 30 60 35 55 95 60 50 20 65 55 50 90 35 55 35 30

28.8 36.3 27.5 30 27.5 23.8 28.8 23.8 22.5 11.3 22.5 40 38.8 30 13.8 20 15 20 31.9 21.3 18.8 15.6 18.8 Av 24.6 SD 7.79

35 20 15 15 15 15 15 15 15 5 20 30 15 30 20 30 20 15 20 25 15 5 10

20 20 20 20 20 15 15 20 20 10 15 20 30 20 15 25 10 20 15 20 5 10 10

25 30 30 35 30 20 30 20 15 5 20 20 25 25 10 5 10 15 35 20 10 5 15

30 40 20 35 25 20 40 20 15 NA 35 NA 25 35 10 15 NA 10 NA 20 NA NA 15

35 40 25 40 35 35 50 15 25 10 40 60 25 40 15 35 10 15 60 25 30 15 10

27.5 27.5 21.3 26.3 22.5 17.5 25 18.8 16.3 6.9 22.5 27.5 23.8 27.5 13.8 18.8 12.5 15 29.4 21.3 12.5 7.5 12.5

1.3 8.8 6.2 3.7 5 6.3 3.8 5 6.2 4.4 0 12.5 15 2.5 0 1.2 2.5 5 2.5 0 6.3 8.1 6.3 Av 4.90 SD 3.77

26.2 100 22.5 92 16.3 100 22.6 100 15 100 23.7 100 8.7 92 30 100 36.3 100 9.4 100 30 100 37.5 88 17.5 100 22.5 100 23.1 100 31.3 96 21.3 100 25 100 25 92 15.6 100 9.3 100 10 100 30 100 Av 22.1 Av 98.3 SD 8.39 SD 3.58

*PTA and air-bone gap based on four-tone average of 500, 1000, 2000, and 3000 Hz (or mean of 2 k and 4 k if NA).

patients and specific testing in background noise will be required.160 Authors have previously noted difficulties with footplate surgery when the stapes superstructure is preserved and partially obscures the footplate. Early stapes mobilizations failed frequently because of refixation of the fracture made through the anterior otosclerotic focus.2 Division of the footplate posterior to the margin of the otosclerotic focus and wide separation of the anterior crus (to prevent fusion of the crus), when possible, produced a

high rate of lasting success.29,35,161 Histopathological studies examining stapes footplates mobilized years earlier have demonstrated healing with a fibrous union when the fracture did not involve the otosclerotic focus.51,52 These studies suggested that the enchondral bone of the stapes footplate may be resistant to bony healing, which would favor long-term results with a stapedioplasty. It is unknown whether laser burns through the stapes footplate will affect the healing process influencing a fibrous or bony repair. It is also unknown whether laser burns

TABLE X. Six-Month or Greater Postoperative Audiometric Data After Stapedotomy.

Pure Tones (Air) Patient No. Pure Tones (Bone) PTA* (Bone) dB ABG (dB) Improvement in ABG (dB) SDS (%)

F/U (mo) 500 1000 2000 3000 4000 8000 PTA* (Air) dB 500 1000 2000 3000 4000

1 3 4 5

9 11 14 6

30 30 25 25

25 35 20 20

20 40 35 15

NA 30 40 NA

25 45 40 35

55 35 60 25

24.4 33.8 30 21.3 Av 27.4 SD 5.60

25 30 15 10

15 35 20 10

20 35 35 15

NA 25 40 NA

25 35 40 25

20.6 31.3 27.5 13.8 Av 23.3 SD 7.73

3.8 2.5 2.5 7.5 Av 4.1 SD 2.36

23.7 28.8 1.2 12.5 Av 16.6 SD 12.2

100 92 100 100 Av 98.0 SD 4.00

*PTA and air-bone gap based on four-tone average of 500, 1000, 2000, and 3000 Hz (or mean of 2 k and 4 k if NA).

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Fig. 15. Intraoperative view of left stapes with gradient-index lens laser endoscope. Contact laser tip is evident at periphery of image at 11 oclock position.

through an otosclerotic focus could impede regrowth and expand the indications for stapedioplasty beyond cases of limited anterior otosclerosis. Early anterior crurotomy and stapedioplasty techniques were difficult and results somewhat unpredictable without the precise tools of modern microdrills and lasers. Fiberoptic delivered lasers make it possible to direct energy onto areas of the stapes and footplate that may not be visible with the operating microscope. It has been suggested that fiber delivered lasers could be used to revive these stapes preservation techniques, and Silverstein1 has shown favorable early clinical results. Silverstein noted difficulties in performing the technique attributable to problems visualizing the anterior crus and entire footplate. He removed more scutum than is customary, to improve visualization and allow for a bent argon laser fiber to contact the anterior crus. Two patients had inadvertent fractures of the posterior crus, presumably attributable to the difficulties of manipulating the bent laser probe around difficult-to-visualize areas. Some of the stapes could not be mobilized and surgery was converted to a prosthesis technique. Improvements in stapedioplasty technique could be gained by better visualization devices, more optimal laser wavelengths, and angled laser delivery systems. Endoscopes were examined to enhance the visualization of the footplate and anterior crus with an intact stapes superstructure. Previous fiberoptic images had poor resolution, and Hopkins rod rigid lenses are considerably larger and awkward in middle ear surgery. The fiberoptic argon and diode laser endoscopes with 10k imaging pixels that were used in this study demonstrated improved optics over previous fiber instruments, but the resolution was still lacking compared with an operating microscope and was thought to be insufficient. The advantages of the laser probe fitted with the 3-mm protruding laser tip were that the entire instrument could be held in one hand and the tip was visible in the endoscopic field. It Laryngoscope 110: May 2000

was very convenient to use but sometimes required alternating between using the laser, then returning to the microscope, to really appreciate what the laser had accomplished (Figs. 15 and 16). The protruding tip allowed the endoscope to be easily used for palpation, and there were no problems with splatter onto the endoscope lens. The fiber tip protruded straight forward and a frequent problem was encounteredthat a laser target could be easily seen within the 85-degree endoscope view angle but the laser tip could not be angled and brought onto the target. An angled laser tip will be necessary for expanded uses in the future, since the principal use of an endoscope is to visualize around the corners that cannot be negotiated with a microscope. The GRIN endoscopes appeared to be a significant advance in design of small endoscopes. The images were not as bright and resolution was not as sharp as a Hopkins

Fig. 16. Intraoperative view of same ear as in Fig. 15, visualized with operating microscope for comparison.

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rod lens, but at less than half the diameter, the improved facility of use was promising. The GRIN scope that was used was 0.5 mm in diameter but was bundled into a laser package for a total OD of 1.2 mm. The image quality was sufficient to perform surgical procedures without continuously returning to the operating microscope. The size was small enough that it could be maneuvered close to the ossicles and the 0-degree view angle made it easier to operate with a separately handheld laser than if it had been an angulated view. Hopkins scopes so large that they cannot be maneuvered close to the ossicular chain and generally require a 30-degree view angle for middle ear surgery. GRIN endoscopes may be useful in future designs of small endoscopes and endoscopic laser devices. The limitations of CO2, argon, and KTP lasers for otological surgery are well known. Argon and KTP lasers, which are most commonly used for stapes surgery, are actually poorly absorbed by bone and work only because there is usually sufficient hemoglobin exposed in the very thin bone of the stapes. Slightly thicker bone in the footplate or posterior crus produces difficulties in penetration with these visible lasers. It seems clear that technological improvements are still required to improve the techniques for stapes surgery without a prosthesis. It has been anticipated that newer mid-IR lasers will become available that will be absorbed well by water, as with CO2 lasers, and still be fiberoptic delivered, as are argon and KTP lasers. The only mid-IR lasers commercially available to date have been pulsed varieties such as erbium, holmium, and pulsed thulium lasers. Pulsed mid-IR lasers operate around the peak absorption wavelength for water (3.0 m) and were hoped to become the next advance in otological lasers. Their high water absorption would be useful in all tissue types, regardless of pigmentation, and overlying perilymph would be protective of the membranous labyrinth during stapes footplate fenestration. The pulsed quality would be favorable for creating sharp vaporization craters with minimal adjacent thermal injury. However, the pulsed quality produces sufficient acoustic shock that the potential for hearing injury from noise trauma and propagation of the photomechanical impact with concussive and shearing forces on the labyrinthine hair cells are very significant concerns. Hearing injury has been documented in guinea pigs150 and to a limited degree in the first clinical experience using the erbium laser.155 It is possible that prolonging the pulse width in future designs would reduce the acoustic shock sufficiently to minimize the potential for hearing injury while still preserving the lasers favorable bone vaporization characteristics. Continuous-wave lasers with IR outputs and improved water absorption characteristics remain in the prototype category at present. The thulium CW laser appeared to have many of the desired properties and functioned nicely in cadaver tissues. Further studies with these prototype devices will be needed. A promising new category of IR lasers is the diode type, since they are efficient, fiber delivered, and relatively inexpensive. Current commercially available diode lasers with clinically useful outputs from 1 to 10 W operate only in near-IR range, which falls into the trough Laryngoscope 110: May 2000

between hemoglobin and water absorption. They were not useful for free beam photothermal outputs in most tissues evaluated in this study unless the tissue were darkly pigmented or stained with dark blood or the tissue absorption was enhanced with ICG dye. Evaluation of near-IR lasers and the associated delivery systems was performed in the anticipation that mid-IR diode lasers already exist in the milliwatt output range and it is probably just a matter of time before these wavelengths are available in clinically useful outputs up to 10 W. Laser endoscopic stapes surgery with the diode laser using ICG to improve absorption proved useful. We have made CAP measurements of auditory thresholds in guinea pigs and did not find any significant acute hearing changes with CW diode laser exposure. The auditory measurements will be presented in a separate report. Contact laser probes available with the diode laser provided a potentially new surgical tool for otological surgeons. Contact tips have been widely used with the Nd: YAG laser but threw off so much heat that it would have been inconceivable to use them in an ear. Contact fibers heat more slowly than photothermal methods and may occur over a relatively broad tip, producing wide margins of adjacent thermal injury, particularly in bone. The 100- m fiber used in this study focused the heat so well that focal burns closely resembled those of conventional otological lasers. The thermal measurements in the vestibules averaged 3.3C of elevation and did not exceed 4.3C of elevation with the 100- m fibers when making 10 burns on the footplate. Elevations up to 3.5C have been previously described as modest.162 The temperature elevation could easily be reduced by spacing each burn by 5 to 10 seconds. The contact probe behaved much like a fiberoptic (free beam) probe with poor effect on nonpigmented tissue until it was thoroughly burned-in, applying it to soft tissue or blood for multiple burns and creating some char on the tip. Caution must be exercised to be certain that the tip is reproducibly heating tissue before applying it to the stapes. If the probe were used without the burning-in procedure, heating of as much as 26C occurred in the vestibule thermal measurements without any significant superficial burn to warn the surgeon of ongoing underlying injury. The diode laser energy is poorly absorbed by the white footplate and has a penetration distance of about a centimeter in water as a free beam. Fiber manufacturers may be able to improve the contact performance of future tips to reduce the potential for free beam (photothermal or optical) energy transmission without requiring a burn-in procedure. The 100- m contact fiber should be further investigated for potential use in otological surgery. Once the tip is ensured to be functioning in contact mode, it will vaporize or cauterize tissue, regardless of pigmentation, including blood vessels, granulations, cholesteatoma, and bone. The tip does not rely on optical qualities and may be freely used for cold dissection, unlike a free beam fiber tip, which will lose performance when the tip is contaminated with tissue fluid or debris. Contact fibers could be incorporated into endoscopic devices for precision dissection under direct visualization around corners and within recesses not seen with the operating microscope. Poe: Laser-Assisted Endoscopic Stapedectomy

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In the future, otological endoscopes will be designed in two basic types, rigid lenses for high resolution and smaller, steerable fiberoptics. Small ( 1 mm) rigid lens systems that may combine elements of Hopkins rod and GRIN lenses will be fitted with contact or free beam laser fibers for precise surgical procedures requiring highresolution optics comparable to an operating microscope. These instruments will generally be 0-degree forward viewing. Steerable fiberoptics will be available in smallerdiameter packages with increasingly better resolution as technology is able to increase the number of pixels in small fiber bundles. These devices will be used in tighter recesses and for traveling deeper into the temporal bone to access disease. The smaller size and flexibility of the instruments will offset the reduction in resolution. They will be particularly helpful in the eustachian tube, petrous apex, and cerebellopontine angle. Manufacturers will be tasked to produce fiber tip designs that will protrude from the endoscope imaging bundle 3 to 5 mm, as in the prototype evaluated in this study. A laser tip flush with the endoscope tip must be brought into near or actual contact with the tissues for cold dissection and laser treatment. A protruding tip removes the potential for thermal injury or splatter to the imaging fibers and permits free beam tips to be brought into near contact for optimal performance while remaining in clear endoscopic focus. Angulation of the tips will be necessary to take advantage of the wide fields of endoscopic view, particularly in the rigid endoscopes. Mid-IR diode lasers will probably be available in the not too distant future. As with other diode lasers, highefficiency performance will make them small, portable, and relatively inexpensive. The availability of lasers in otological surgery may increase beyond just the major medical centers and possibly into the practitioners offices. It is anticipated that endoscopic coupling with these lasers will increase the ability to do minimally invasive otological surgery such as debridement and definitive cauterization of limited cholesteatomas, myringotomies, vaporization of retraction pockets, spot-welded tympanoplasties, eustachian tube surgery, and other middle ear and mastoid treatments in an outpatient or office setting. Endoscopic laser-welded tympanoplasties are already being routinely performed by the author and will be presented in the future. There is potential for image-guided interstitial placement of these devices into cavities within the skull base and cerebellopontine angle for treatment of lesions such as cholesterol cysts, epidermoid tumors, glomus and tumors. For the present, the currently available diode lasers with the 100- m contact tip should be further studied for possible clinical potential. The early clinical experience with stapedioplasty reported by Silverstein1 and in the present study suggests that the techniques are feasible with short-term results comparable to conventional stapedotomy. The stapedioplasty patients in the present study demonstrated improved hearing results at the 6-week and 6-month follow-up periods comparable to the stapedotomy control group. The postoperative air-bone gap at 6 weeks was 8.3 dB (SD 9.8) for stapedioplasty and 4.9 dB (SD 3.77) for stapedotomy. The gap and SD were slightly higher for the Laryngoscope 110: May 2000

stapedioplasty group because of patient 2, who was not successful in closing the gap, and patient 8, who had an upper respiratory tract infection and effusion at the postoperative visit and subsequently improved the gap to 10 dB. Six-month follow-up was obtained in 8 of the 11 stapedioplasty patients and showed that there was little overall change with the air-bone gap at 10.8 dB (SD 9.4). Patient 5 showed a significant drop in air-bone gap from 5.1 dB at 6 weeks to 14.4 dB at 6 months, but the 6-month bone line was considerably improved while the air line changed little from pure-tone average (PTA) 21.9 dB to PTA 26.3 dB. There were no other significant changes in the air-bone gaps at 6 months, and it would appear that bone refixation with return of a preoperative air-bone gap has not occurred in any patient. It may be concluded that in this preliminary study of stapedioplasty, it is possible to obtain short-term results comparable to conventional stapedotomy without an increase in complication rates. The 6-month follow-up results have not shown refixation of the footplate in any case to date, and further study of the technique is warranted to determine long-term outcomes in larger cohorts. Six of the stapedioplasty patients have been followed up for more than 1 year and have all maintained their air-bone gap closure, demonstrating that continued mobility of the stapes over time is possible. The second patient to undergo the procedure did not have a satisfactory closure of the air-bone gap, which was likely, in retrospect, to be a failure to adequately judge the stapes mobility. It was noted that some flexibility of the posterior crus on palpation may be misinterpreted as footplate mobility. True footplate mobility must be judged by direct visualization of vertical displacement of the posterior footplate relative to the stationary anterior segment during palpation of the posterior crus or footplate itself. There was a large enough gap in the footplate after division that observation for a round window cochlear reflex to stapes movement was unsuccessful. The indication for stapedioplasty in otosclerosis is limited to the anterior third of the footplate. It should be otherwise thin and apparently free of otosclerotic fixation around the annular ligament beyond the margin of the anterior third. Most of the anterior and middle footplate should be visible, despite the intact stapes superstructure. If the footplate is not easily mobilized with footplate division, the procedure may be converted to a standard stapedotomy with piston by separation of the ISJ, lysis of the stapedius tendon, and laser fenestration of the footplate. Thirteen patients (38.2%) appeared to be candidates for stapedioplasty in this study and had an attempt made. Two of the 13 (15.4%) patients were converted to conventional stapedotomy because of inability to adequately mobilize the footplate. Improvements in technique with appropriate instrumentation would be expected to increase the number of successful stapedioplasties. Longer-term studies will be required to determine a rate of refixation, which will ultimately determine whether stapedioplasty would be a worthwhile procedure. There was no statistical significance between the preoperative hearing levels and the intraoperative pattern or extent of otosclerosis. Larger numbers of patients in the future may reveal trends that could help predict the poPoe: Laser-Assisted Endoscopic Stapedectomy

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tential for stapedioplasty preoperatively. For now, patients must be counseled that stapedioplasty may be attempted based on limited otosclerotic involvement, favorable anatomy, and ability to mobilize the footplate once the procedure is attempted. Causse (personal communication, February 1998) has cautioned that blind laser applications to the superior rim of the footplate could risk injury to the sacculus, which becomes more superficial superiorly. It is recommended that the laser be applied only where directly visualized and that an oval window pick or rasp could be used to palpate and divide remaining areas of footplate fixation out of sight. Endoscopes improve the footplate visualization, but currently most are not well suited for this purpose. Fiberoptic endoscopes used in this study had insufficient resolution, and Hopkins rods were too large in diameter to be practical and work the laser fiber around them. Some footplate and anterior crus burns were performed using the rod endoscope and a separately handheld argon laser fiber, but the technique was quite difficult. Lysis of the anterior crus with the laser fiber endoscope prototype was far easier to perform with a single instrument, but the lack of an angled laser tip prevented any useful footplate surgery unless a separately handheld laser fiber were introduced. A GRIN endoscope with superior optics combined with angled laser tips should significantly facilitate the anterior crus and footplate surgery in the future.

CONCLUSION
Stapedotomy without a prosthesis (stapedioplasty) is a less invasive procedure than prosthesis insertion and may be shown in the future to reduce the complications associated with footplate fenestration including sensorineural hearing loss, vertigo, infection, and granuloma formation. Prosthesis problems and incus necrosis should be eliminated. Improved hearing in background noise may occur with preservation of the stapedius tendon, and hyperacusis may be reduced. Performance of the stapedioplasty may be a technically more challenging procedure than conventional stapedotomy because the intact superstructure impedes the view of the entire footplate and division of the anterior crus must often be accomplished without direct visualization. Currently available endoscopes may improve visualization but remain impractical and await modifications designed for the limited spaces of the middle ear. Present fiber delivered lasers are usually satisfactory but have limited vaporization capability on bone and may present risks to the sacculus when operated near the superior rim of the oval window where the sacculus is most superficial, since the wavelengths are not absorbed by perilymph. This study found that endoscopes did improve the views of the anterior crus and stapes footplate, but each system that was evaluated had drawbacks. The fiberoptic laser endoscope was most favorable, providing an adequate field of view and a protruding argon laser tip that worked well on the anterior crus and limited areas of the footplate. An angled tip would be needed to reach into the recess below the superstructure to complete the operation with the laser endoscope alone. The resolution of the fiber Laryngoscope 110: May 2000

endoscope was insufficient for its exclusive use and required frequent use of the operating microscope. Improved fiberoptics with increased pixels may result in future fiber devices of adequate resolution. The GRIN endoscope provided excellent resolution in a small diameter suitable for stapes surgery but lacked an argon laser fiber for clinical use. Separate handheld laser fibers may be used, and intrinsic laser capability with other wavelengths is recommended with a protruding straight and angulated tip. Various laser types were assessed in searching for the following characteristics that would most closely approximate the ideal otological laser: 1. High water absorption. 2. Fiber delivery system. 3. No acoustic shock. 4. Clean vaporization of tissue with minimal adjacent thermal injury. Pulsed lasers currently are not recommended, since they have been shown to have acoustic shock properties that may cause significant injury to the labyrinth. The CW thulium laser showed initial promise as a fiber delivered, mid-IR laser (2.1 m), with favorable soft tissue and bone effects. In its present form it is a large, water-cooled, expensive device that is unlikely to be clinically available in the immediate future and requires further study. The diode lasers in the mid-IR range are fiber delivered but lack the power for clinical use. They are expected to become important in the future as efficient and inexpensive devices that may expand laser capability to many more medical centers and offices. Current diode lasers operating in the near-IR range may be useful in otology with contact probe fibers. This study demonstrated that the bone and soft tissue effects with a 100- m conical tapered tip were very favorable and elevated vestibule temperatures a mean of 3.25C and no more than 4.3C during stapes footplate applications. Further study of the contact probes should be performed to determine the clinical potential of these devices, which are currently available. If results are satisfactory, they could be incorporated into endoscopic devices and advance the ability to perform minimally invasive procedures in otology. Stapedioplasty has been demonstrated to have the capability of acutely closing the air-bone gap as well as with a conventional procedure with a prosthesis. One-year results that fibrous healing and not bony refixation may occur in the majority of cases are encouraging, but longterm follow-up will be essential to determine the true failure rate. Endoscopic visualization and improved laser wavelengths and delivery systems promise to simplify the technical demands of current stapedioplasty and possibly increase the indications.

ACKNOWLEDGMENT
Credit is gratefully given to Mark Sabo for medical illustrations and Kathy Hicks for manuscript preparation.

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