Potential nerve damage following contact with a piezoelectric device.

OBJECTIVES: The aim of the study was to assess the extent of the potential nerve damage following prolonged contact with a piezoelectric device. METHODS: The study was conducted with 30 patients; all of the patients had cervical metastatic lymph nodes at levels II, III, and IV (N2b) and a negative evaluation for metastatic disease (MO). The patients underwent radical neck dissection. After its skeletonization, the spinal nerve was exposed directly to ultrasonic activation with a piezoelectric device for various times (5, 10, and 20 seconds) and with different inserts (OP3 insert and OT7 insert). The axonal damage was graded from 0 to 3 as follows: 0, no damage; 1, minor axonal damage; 2, severe axonal damage but not covering the entirety of the nerve fascicles; 3, severe axonal damage covering the entirety of the nerve fascicles. RESULTS: Histologic examination showed no evidence of damage to the perineurium and axons after 5 and 10 seconds of exposure to ultrasonic activation with each insert. CONCLUSIONS: Our histologic data highlight the selective action of the piezoelectric device, which reduces the risk of accidental nerve damage in otolaryngological bone surgery.

A prognostic multigene classifier for squamous cell carcinomas of the larynx.

Survival after diagnosis of laryngeal cancer has not improved over the last 20 years. Selection of patients for radio- and chemotherapy or surgery or follow-up strategies based on a prognostic classifier could improve survival without unduly extending radical surgery. We performed microarray gene expression analysis and developed a four-gene classifier for laryngeal cancer using Prediction Analysis of Microarray and leave-one-out cross validation. A four-gene classifier containing the non-coding gene H19, the histone HIST1H3F and the two small nucleolar RNAs, SNORA16A and SNORD14C was developed that assigns cases to low and high risk classes. The high risk class has a relative risk of 6.5 (CI=1.817-23.258, Fisher exact test p<0.0001). The maternally imprinted gene H19 is the top classifier gene.

Comparison of postoperative pain: piezoelectric device versus microdrill.

Piezosurgery® is a recently developed system for cutting bone with microvibrations. The objective of this study was to compare the severity of pain over the first 10 postoperative days in a group of 70 patients who underwent intact canal wall mastoidectomy, with the piezoelectric device, and to compare the results with traditional method by means of microdrill (70 patients). The subjective perception of pain was evaluated on a scale from 0 to 10, such that 0 represented no pain and 10 represented maximum pain; the severity was recorded as null when the score was 0; slight, when it was 1-4; moderate, when it was 5-7; or severe, when it was 8-10. Compared with microdrill, the patients that underwent surgery with the piezoelectric device showed a significant (P < 0.05) lower postoperative pain on day 1 (52 vs. 26 patients presented a slight pain, 12 vs. 37 presented a moderate pain, and 6 vs. 7 presented a severe pain) and day 3 (68 vs. 44 patients presented a slight pain, 2 vs. 23 presented a moderate pain, and 0 vs. 3 presented a severe pain). These results highlight as the piezoelectric device is a safe and minimally invasive tool.

Water-soluble coenzyme Q10 formulation in presbycusis: long-term effects.

CONCLUSION: These findings provide the basis for understanding the duration of the effect after the last use of the drug and encourage a larger clinical trial to collect additional evidence on the effect of coenzyme Q10 (CoQ10) in preventing the development of hearing loss in subjects with presbycusis. OBJECTIVES: The aim of this study was to evaluate the long-term effects of a water-soluble formulation of CoQ10 (Q-TER) in subjects with presbycusis. METHODS: Sixty patients with presbycusis were included and divided at random into three numerically equal groups. For 30 days, group A underwent therapy with Q-TER, group B underwent therapy with vitamin E, and group C received placebo. Before, at the end, and 6 months after the end of the treatment, all patients underwent evaluation of pure tone audiometry, transient evoked otoacoustic emissions and otoacoustic products of distortion, auditory brainstem response, and speech audiometry. RESULTS: Compared with group B, at the end of the treatment in group A the pure tone audiometry showed a significant (p < 0.05) improvement of the audiometric thresholds at 1000, 2000, 4000, and 8000 Hz. This improvement was confirmed by the speech audiometry and last check. We found no significant differences in the other parameters and in group C.

Comparative evaluation of user interfaces for robot-assisted laser phonomicrosurgery.

This research investigates the impact of three different control devices and two visualization methods on the precision, safety and ergonomics of a new medical robotic system prototype for assistive laser phonomicrosurgery. This system allows the user to remotely control the surgical laser beam using either a flight simulator type joystick, a joypad, or a pen display system in order to improve the traditional surgical setup composed by a mechanical micromanipulator coupled with a surgical microscope. The experimental setup and protocol followed to obtain quantitative performance data from the control devices tested are fully described here. This includes sets of path following evaluation experiments conducted with ten subjects with different skills, for a total of 700 trials. The data analysis method and experimental results are also presented, demonstrating an average 45% error reduction when using the joypad and up to 60% error reduction when using the pen display system versus the standard phonomicrosurgery setup. These results demonstrate the new system can provide important improvements in terms of surgical precision, ergonomics and safety. In addition, the evaluation method presented here is shown to support an objective selection of control devices for this application.

Next-generation micromanipulator for computer-assisted laser phonomicrosurgery.

This paper describes a new motorized laser micromanipulator created for computer-assisted laser laryngeal microsurgeries. This new device is based on a single tip/tilt fast steering mirror driven by a parallel kinematics mechanism, which is shown to improve previous laser micromanipulator designs by offering highly accurate motorized laser aiming control from a small, simple, and robust system created for real operating settings. The integration of this new device to a previously developed assistive surgical system is also described, including the new calibration model implemented to enable precise laser beam control from the live microscope video displayed on a computer screen. High system accuracy is demonstrated by the results of trajectory following experiments, which reveal an average RMSE of only 0.06 mm over an 8.5 mm diameter circular path. These numbers are also shown to favorably compare to those obtained with a traditional laser micromanipulator, evidencing a 70% error reduction when using the new system. In addition, experiments under higher optical magnification (40× instead of 16×) demonstrate even better accuracy results, proving the new system is highly scalable and indicating it has the potential to greatly improve laser microsurgery quality and safety.

Design and control of a robotic system for assistive laser phonomicrosurgery.

This paper presents the design, implementation and control of a novel robotic system for assistive laser phonomicrosurgeries. The goals here are to improve the precision, the controllability, the safety and the ergonomics of traditional transoral laser laryngeal surgeries. Successful steps achieved by the developed system in those directions are presented here, including the design, control and characterization of a novel laser micromanipulator system. Such system is shown to achieve very fast (181mm/s) and accurate (1µm resolution) laser beam aiming within an 11×11mm target area. The design and implementation of a high-level control system for safe operation of the new laser phonomicrosurgery equipment is also described in this paper. This controller runs on a personal computer, offering a comfortable and safe surgical environment for the surgeon. In addition, it implements safe teleoperation by allowing the definition of safe and exclusion zones for surgical laser aiming. Automation of ablation procedures is also implemented on this high-level controller and described here. This feature adds an extra level of safety for phonomicrosurgeries by allowing the precise execution of surgical plans defined by the surgeon.

Nasal tactile sensitivity in elderly.

CONCLUSION: Although older people varied widely in tactile sensitivity, our results show that tactile thresholds increased with age. OBJECTIVES: The aim of this study was to evaluate the effects of aging on nasal tactile sensitivity. METHODS: A total of 160 healthy patients aged between 50 and 90 years were included. According to their age, patients were divided into groups (A, B, C, D, E, F, G, and H). From the age of 50, each group included subjects with an age range of 5 years (i.e. group A, 50-55 years; group B, 56-60 years, etc.). Each patient's outcome was assessed through the nasal monofilament test: a set of 20 Semmes-Weinstein monofilaments was used to detect nasal sensitivity for both nasal cavities. The sensitivity threshold was recorded as the minimum monofilament size from which patients could detect at least two of three stimuli. RESULTS: In groups D (66-70 years), E (71-75 years), F (76-80 years), G (81-85 years), and H (86-90 years) a significantly (p < 0.05) higher stimulus (171.1 ± 0.34 mg vs 67.7 mg, 167.01 ± 0.31 mg 67.7 mg, 166.54 ± 0.28 mg 67.7 mg, 201.24 ± 0.43 mg 67.7 mg, 165,87 ± 0.27 mg 67.7 mg) was required to trigger a touch response in the monofilament test.

Computerized voice therapy in hypofunctional dysphonia.

OBJECTIVE: The aim of this study was to analyze the efficiency and applicability of the Kay CSL 4500 system with the Sona-Speech II software model 3650 (Kay Pentax, Lincoln Park, NJ) in the voice therapy of patients affected by hypofunctional dysphonia. DESIGN: The study evaluated the effect of visual biofeedback, obtained with the Sona-Speech II software, on dysphonia associated with hypofunction dysphonia. SETTING: The study was conducted with 40 male adults affected by hypofunctional dysphonia in the Otolaryngology Department of the University of Genoa (Italy) between April 2008 and April 2009. METHODS: Before, at the end of, and 3 months after voice therapy, all subjects underwent an otolaryngology visit, videostroboscopy, and voice analysis through the Multi-Dimensional Voice Program (Kay Elemetrics, Lincoln Park, NJ) as an evaluation of nasal resonance and the Voice Handicap Index (VHI). Each cycle of rehabilitation was characterized by 30 daily consecutive sessions, each for 25 minutes. During each session, the patient was asked to perform specific computer exercises. MAIN OUTCOME MEASURES: The following acoustic parameters were estimated: average of fundamental frequency, percentage of jitter, shimmer, noise to harmonics ratio, voice turbulence index, soft phonation index, degree of voicelessness, degree of voice breaks, and peak amplitude variation. RESULTS: Our data showed significant (p < .05) improvements in acoustic and other parameters in the patients submitted to voice therapy. CONCLUSIONS: Our preliminary results suggest the applicability and efficiency of the Kay CSL 4500 system in association with the Sona-Speech II software model 3650 in a voice therapy program.

Piezoelectric stapedotomy: the importance of a micropulse program.

CONCLUSIONS: We can consider the micropulse program as the best level of safety that should be used in all cases of piezoelectric stapedotomy. OBJECTIVES: The aim of this study was to describe the importance of a micropulse program in determining the success of piezoelectric stapedotomy. METHODS: A total of 112 patients (group A) affected by primary otosclerosis underwent piezoelectric stapedotomy for otosclerotic stapes fixation. A specific operative program was created to perforate the stapes footplate: this program makes it possible to perforate the footplate of the stapes with a predetermined and non-modifiable temporization. Before and 1 year after surgery, all the patients underwent the following instrumental examinations: pure-tone audiometry, tympanometry, transient-evoked otoacoustic emissions, distortion product otoacoustic emissions, and auditory brainstem response. Results were compared with those obtained from 30 patients who underwent piezoelectric stapedotomy without the specific operative program (group B). RESULTS: At 1 year after surgery, with regard to the pure-tone audiometry test, all patients had an air-bone gap (ABG) reduction: no worsening of the bone conduction and no postoperative sensorineural hearing loss were found. In group A, there was a closure of the ABG within 10 dB in all patients.

Piezosurgery for removal of symptomatic ear osteoma.

Piezosurgery is an ultrasound instrument (24.7-29.5 kHz) that is able to cut the bone without necrosis and nonmineralized tissue damage. The aim of this work has been to determine the applicability and efficiency of the piezoelectric device in the excision of symptomatic ear osteomas. 10 patients affected by osteoma of the external auditory canal (EAC) (6 right, 4 left) were enrolled. Patients underwent excision of the EAC osteoma through a transcanal approach, with the piezoelectric device. Before and 6 months after surgery, all the patients underwent pure-tone audiometry, tympanometry, transient-evoked otoacoustic emissions, distortion product otoacoustic emissions, auditory brainstem response, and electronystamographic recording. The piezoelectric device provided excellent control without side effects on the adjacent structures of the external, middle and inner ear. The piezoelectric device is a new bony scalpel using the microvibrations at ultrasonic frequency so that soft tissue (nerve, vessel, dura mater, skin, etc.) will not be damaged even on accidental contact with the cutting tip. A feature of the piezoelectric device is its good manageability, which makes it easy for a well-trained otologic surgeon to create a straight osteotomy line: this renders the piezoelectric device suitable for bone surgery and for removal osteomas of the EAC.

Piezosurgery versus microdrill in intact canal wall mastoidectomy.

Piezosurgery is a recently developed system for cutting bone with microvibrations. The objectives of the present study were to report our experience with the piezoelectric device in the intact canal mastoidectomy, and to compare the results with traditional method by means of microdrill. A non-randomized controlled trial was undertaken on 60 intact canal wall mastoidectomy performed using the piezoelectric device (30 patients) or the microdrill (30 patients). Before 1 month and 1 year after surgery, all the patients underwent the following instrumental examinations: otomicroscopic evaluation of the tympanic membrane and external auditory duct, bone conduction threshold audiometry, tympanometry, transient-evoked otoacoustic emissions with linear click emission, distortion product otoacoustic emissions, auditory brainstem response (ABR) by MK 12-ABR screener with natus-ALGO2e (Amplifon, Milan, Italy), and electronystamographic recording. The piezoelectric device is proved to be effective in sclerotic and pneumatic mastoid, with an excellent control and without side effects on the adjacent structures of the middle and inner ear (lateral sinus, facial nerve, and/or dura mater). The operation time has been the same as compared with microdrill, and the average hospital stay was significantly (p < 0.05) shorter. Postoperatively, all patients had uneventful recovery with no evidence of audiovestibular deficit or side effects. Our experience highlights the safety of the piezoelectric device on the anatomic structures of the middle and inner ear, and demonstrates its efficiency in terms of cutting precision and healing process.

Sulphurous thermal water inhalations in the treatment of chronic rhinosinusitis.

INTRODUCTION: The aim of this study was to evaluate the efficiency of sulphurous thermal water in the treatment of chronic rhinosinusitis (CRS). METHODS: Eighty patients with CRS were included and randomly assigned into two groups. Patients underwent a 12-day course of warm vapour inhalations and nasal irrigations with sulphurous thermal water in group A, and a physiological solution in group B. RESULTS: Compared with group B, in group A the results were as follows: serum concentration of IgE was significantly lower (p<0.05) 12 days (76.27+26.3 mg/dl vs. 97.44±45.4) and 3 months after the beginning of the treatment (75.48+26.1 mg/dl vs. 98.37±41.4); IgA titers were not significantly higher 12 days (231.09±120.3 mg/dl vs. 220.44+114.4 mg/dl) and 3 months after the beginning of the treatment (235.44±118.5 mg/dl vs. 214.51±111.8 mg/dl); VAS scores were significantly (p<0.05) improved at 12 days (1.7+0.18 vs. 6.9±0.51) and 3 months after the start (1.8+0.22 vs. 7.1±0.59); NMIT was normal at 12 days (11.54±1.59 min vs. 17.38+1.83 min) and 3 months after the beginning of the treatment (11.46+2.07 min vs. 17.43±2.01 min); total nasal resistances were significantly (p<0.05) decreased at 12 days and 3 months. CONCLUSION: Our results indicate the efficiency and applicability of sulphurous thermal water in the treatment of CRS.

Water-soluble coenzyme Q10 formulation (Q-TER(®)) in the treatment of presbycusis.

CONCLUSION: These preliminary data are encouraging for a larger clinical trial to collect additional evidence on the effect of Q-TER(®) in preventing the development of hearing loss in subjects with presbycusis. OBJECTIVES: The purpose of this study was to evaluate the efficiency and applicability of a water-soluble formulation of CoQ10 (Q-TER(®)) in subjects with presbycusis. METHODS: A total of 60 patients with presbycusis were included and divided into three numerically equal groups. Group A underwent therapy with Q-TER(®), 160 mg, once a day for 30 days; group B underwent therapy with vitamin E (50 mg), once a day for 30 days; group C received placebo, once a day for 30 days. Before and at the end of the treatment, all patients underwent pure tone audiometry, transient evoked otoacoustic emissions, otoacoustic products of distortion, auditory brainstem response, and speech audiometry. RESULTS: Compared with group B, at the end of the treatment in group A the liminar tonal audiometry showed a significant improvement of the air and bone thresholds at the 1000 (14/20 vs 9/20), 2000 (14/20 vs 7/20), 4000 (15/20 vs 6/20), and 8000 Hz (13/20 vs 5/20). We found no significant differences in the other parameters and in group C.

Results of revision mastoidectomy with Piezosurgery(®).

CONCLUSION: For otologic revision surgery, the advantage of the piezoelectric device appears real because it is possible to perform a 'blind' cutting of bone with fewer precautions necessary for soft tissues such as the facial nerve, lateral sinus, and dura mater. OBJECTIVES: The aim of this study was to determine the efficiency of the piezoelectric device in revision surgery for chronic otitis media. METHODS: A total of 30 patients had revision mastoidectomy with previous canal wall up mastoidectomy. The piezoelectric device was used in all intraoperative steps. Before surgery and 1 month and 1 year after surgery, all the patients underwent the following instrumental examinations: pure-tone audiometry, tympanometry, transient-evoked otoacoustic emissions, distortion product otoacoustic emissions, auditory brainstem response, and electronystamographic recording. RESULTS: The piezoelectric device provided effective cutting, with excellent control and without side effects on the adjacent structures of the middle and inner ear (lateral sinus, facial nerve, and/or dura mater). Postoperatively, all patients had an uneventful recovery with no evidence of audiovestibular deficit or side effects. Among 30 cases followed for 1 year, 29 (97%) maintained a dry and safe ear. Intermittent otorrhea with perforation of the tympanic membrane occurred in one patient (3%).

Stapedotomy with and without piezosurgery: 4 years' experience.

OBJECTIVE: The aim of this study was to present our experiences and results of stapedotomy performed with and without the piezoelectric device. DESIGN: The article evaluates and compares the use of the piezoelectric device in performing primary stapedotomy in patients affected by otosclerosis with the traditional method of microdrilling. SETTING: The study was conducted with 100 patients in the Department of Otolaryngology of the University of Genoa (Italy), between January 2007 and January 2008. METHODS: A prospective, randomized, controlled trial was undertaken on 100 stapedotomy patients performed using the piezoelectric device (50 patients) or the microdrill (50 patients). MAIN OUTCOME MEASURES: Before surgery and at 1 and 12 months afterward, all patients underwent the following: otomicroscopic evaluation of the external and middle ear, pure-tone audiometry, tympanometry, transient evoked otoacoustic emissions, distortion product otoacoustic emissions, and auditory brainstem response. RESULTS: All patients treated with the piezoelectric device had an air-bone gap reduction, with a closure of the air-bone gap within 10 dB; 44 (88%) patients who underwent traditional surgery had an air-bone gap reduction, with a closure of the air-bone gap within 10 dB. CONCLUSION: All of our postoperative data confirm the safety of the device on the anatomic structures of the middle and inner ear and demonstrate the efficacy of the piezoelectric device in terms of safety, cutting precision, and protection of anatomic structures and its applicability to stapedotomy.

Binocular flash-induced nystagmus in humans.

OBJECTIVE: The aim of this study was to demonstrate that binocular flash-induced nystagmus (B-FIN) can be evoked in humans. DESIGN: The study evaluated the presence of B-FIN by stimulation with a stroboscopic flash. SETTING: The study was conducted with 12 healthy patients in the Otorhinolaryngology Department of the University of Genoa (Italy), between April 2008 and January 2009. METHODS: Patients underwent binocular flashing light stimulation, in the dark, by stroboscopic flash presented through a photostimulator at frequencies of 4.7 and 7.69 cycles/second for 120 seconds, with their eyes covered by a homogeneous field hollow opal hemisphere. The photostimulator was placed in three different positions with respect to the anterior-posterior axis: 0 degrees, 45 degrees to the right, and 45 degrees to the left. MAIN OUTCOME MEASURES: Eye movements were recorded by electronystagmography (ENG). ENG recording started 30 seconds before the stimulation and stopped 60 seconds after the end of the luminance stimuli to test the presence of flash induced after nystagmus (FIAN). RESULTS: B-FIN was clearly evoked from 10 of the 12 healthy adults, whereas FIAN was evoked from 4 of the 12 subjects. The best stimulation of B-FIN was obtained through an intermittent luminance stimulus presented at a frequency of 4.7 cycles/second and the photostimulator placed at 0 degrees to the optic axis. CONCLUSIONS: Our investigation demonstrates that B-FIN can be evoked in humans and its possible value in the differential diagnosis between central and peripheral vertigo.

Evaluation of an automated auditory brainstem response in a multi-stage infant hearing screening.

An automated auditory brainstem response (AABR) method, the Maico MB-11 with BERAphone, has been developed for hearing screening in newborns. The aim of this study was to test the validity of this automated ABR screening method in a multistage newborn hearing screening (NHS). We applied a "five level" protocol using transient evoked otoacoustic emission (TEOAE), AABR-MB-11 with BERAphone and conventional auditory brainstem response (ABR). TEOAE, AABR, and conventional ABR testing were performed by ENT specialists experienced in neonatal screening techniques. Among the 8,671 newborns tested (males 3,889; females 4,782), only 42 newborns were lost to follow-up and the final false-positive rate was of 0.03%. Our experience highlights that for the neonatal period, conventional auditory brainstem response is the most reliable method for assessing the hearing level and minimizing the false-positive rate. Although AABR (performed by ENT specialists experienced in neonatal screening techniques) is easy to use, fast and with a good compliance, the device is unable to provide accurate and certain diagnosis on the degree of hearing loss to allow a proper treatment.

Learning curve for Piezosurgery in well-trained otological surgeons.

OBJECTIVE: Piezosurgery is an ultrasound instrument (24.7-29.5 kHz) capable of cutting bone without necrosis and nonmineralized tissue damage. The aim of this work has been to determine the time required for a well-trained surgeon to perform otological surgery with the piezoelectric device. STUDY DESIGN: Case series with planned data collection. Sixty-three patients affected by otosclerosis and 63 by chronic otitis media were enrolled. For each disease, patients were divided into three numerically equal groups, with each group assigned to a well-trained otological surgeon. Patients underwent stapedotomy (n = 63) and intact canal wall tympanoplasty (n = 63) with the piezoelectric device. SETTING: ENT Department, University of Genoa (Italy). SUBJECTS AND METHODS: We recorded "skin-to-skin" operation time, surgical success, surgical complication, and hospital stay duration. Before and one year after surgery, all patients underwent pure-tone audiometry, tympanometry, recording of transient-evoked otoacoustic emission, recording of distortion product otoacoustic emission, auditory brainstem response, and electronystamographic recording. RESULTS: In each surgical technique, the piezoelectric device provided excellent control without side effects on the adjacent structures of the middle and inner ear. CONCLUSION: The piezoelectric device is a new bony scalpel that uses microvibrations at ultrasonic frequency so that soft tissue (nerve, vessel, dura mater, etc) will not be damaged even on accidental contact with the cutting tip. A feature of the piezoelectric device is its good manageability, which makes it easy for a well-trained otological surgeon to create a straight osteotomy line without any learning period: this renders the piezoelectric device suitable for bone surgery.

Ribosomal therapy in the treatment of recurrent acute adenoiditis.

The aim of this study was to evaluate the efficacy of an oral ribosomal immunotherapy in the management of children with recurrent acute adenoiditis (RAA). 60 children with RAA were included and randomly assigned into two groups (group A and B). Group A children underwent ribosomal prophylaxis, while group B received a placebo. Before, at the end and 6 months after start of the therapy, children underwent medical history, ENT examination, plasma levels of immunoglobulins class E, A, G, M (IgE, IgA, IgG, IgM), tympanometry, active anterior rhinomanometry and VAS scores by children' parents. After the treatment and at the end of the study, in the group A, the serum concentration of IgE was significantly (P < 0.05) lower than in group B (77.34 +/- 6.23 vs. 95.49 +/- 7.07 mg/dl; 74.82 +/- 6.26 vs. 94.44 +/- 7.44 mg/dl), IgA titers were significantly (P < 0.05) higher than in group B (312.04 +/- 18.41 vs. 213.20 +/- 11.82; 309.07 +/- 18.33 vs. 211.73 +/- 11.54 mg/dl) as well as serum concentration of IgG (1401.12 +/- 118.81 vs. 1101.81 +/- 109.64 mg/dl; 1412.19 +/- 116.43 vs. 1144.06 +/- 103.58 mg/dl). At the end of the study, comparison between the two groups showed, in group A: 77% of children (n = 23), versus 23% (n = 7) of group B, with a type A tympanogram; significant (P < 0.05) nasal flow decrease at the rhinomanometric measures; VAS scores were significantly (P < 0.05) improved (1.8 +/- 0.22 vs. 5.1 +/- 0.59) and frequency, severity and social impact of RAA episodes were significantly (P < 0.05) lower than group B. Our results show the therapeutic effectiveness of this approach in the prophylaxis of recurrent acute adenoiditis.