Quality of life in patients with oropharyngeal carcinoma after primary surgery and postoperative irradiation.

OBJECTIVE: To assess quality of life in patients with oropharyngeal carcinoma after primary surgery and postoperative irradiation. STUDY DESIGN: Retrospective chart review and patient response to the Short Form 36 (SF-36) Health Survey and the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 and QLQ-H&N35 questionnaires. SETTING: A tertiary care university hospital. RESULTS: One hundred sixty-nine patients with oropharyngeal carcinoma underwent primary surgery followed by postoperative irradiation between January 1997 and February 2002. Eighty-eight disease-free survivors were identified in September 2002 and included in this study. The questionnaires were completed by 34 patients (39% completion rate). Median follow-up was 2.3 years (range 0.5-4.9 years). In oropharyngeal carcinoma patients, five scales of the SF-36 showed significantly reduced scores in comparison with the normal German population: physical functioning, role functioning - physical, general health, social functioning, and role functioning - emotional. Posttreatment scores from the literature fell within the 95% confidence interval of our data except one out of fifteen scales of the EORTC QLQ-C30 questionnaire and six out of eighteen scales of the EORTC QLQ H&N35 questionnaire. The comparison of our data with data from the reviewed literature produced similar results. CONCLUSIONS: General quality of life was reduced in our oropharyngeal carcinoma patients. Primary surgery and postoperative irradiation demonstrated similar results in different studies.

Melanoma of the nose: prognostic factors, three-dimensional histology, and surgical strategies.

OBJECTIVES: The prominent position of the nose in the face accounts for its constant exposure to sunlight and thus its high incidence of malignant involvement. The aim of this prospective study was to define prognostic factors for nasal melanomas and to evaluate surgical strategies. METHODS: Forty-five patients with stage I/II melanoma were included. Malignant melanomas of the nose represented 0.8% of stage I/II cutaneous melanoma and 5.3% of head and neck melanoma (1983-2004). The median tumor thickness was 0.75 mm. Twenty-two of 33 Lentigo maligna melanomas (LMM) underwent three-dimensional (3D) histology in paraffin technique (i.e., micrographic surgery). RESULTS: The 5 year disease-specific survival rate was 96%, and the 5 year recurrence-free survival rate was 93%. There were no statistically significant risk factors in the univariate analysis. LMMs that were removed with accompanying 3D histology were thinner than other histologic types (median 0.75 vs. 1.55 mm). Compared with conventional histology, using 3D histology made it possible to reduce the excision margins (median 5 vs. 10 mm). There was one lymph node recurrence after LMM with 3D histology. Of five sentinel lymph node biopsies (SLNB) there was no positive SLNB and no recurrence. CONCLUSION: This is the largest study of nasal melanomas so far. Excision of LMM using 3D histology allowed the reduction of excision margins for better cosmesis and function. Our results do not permit conclusions regarding the prognostic impact of SLNB.

In vitro model for intraoperative adjustments in an implantable hearing aid (MET).

OBJECTIVE: Assessment of the optimal static preloading of Otologics Middle Ear Transducer (MET) Ossicular Stimulator, when coupled to the incus. BACKGROUND: The MET Ossicular Stimulator is a partially implantable electromagnetic middle ear hearing device that transmits vibrations to the ossicular chain. The vibration patterns were measured with laser-Doppler vibrometry. STUDY DESIGN: Experimental. MATERIAL: We used three human cadaveric temporal bones (TB) and one MET ossicular stimulator. METHODS: Laser-Doppler vibrometry was used for the selection of TBs. The cochlea was subsequently extirpated from the posterior side to measure the vibrational patterns (VP) of the footplate. Three TBs with different VP were selected based on data obtained from volunteers with normal hearing (n = 110): one TB with a VP larger than +1 SD, one TB with a VP in the range of +/-1 SD, and 1 TB with a VP smaller than -1 SD. Transfer functions were calculated between VP of the measurement points at the coupling rod, umbo, incus, and footplate. The TBs were subsequently defrosted. The MET was implanted and coupled to the ossicular chain. Different coupling loads were measured at the incus, the umbo, and the footplate. RESULTS: Optimal transfer function between the MET transducer and the oval window was achieved during contact when the coupling rod advanced 0.0625 mm (90 degrees rotation). Additional advances of 0.0625 mm (180 degrees turn = 0.125 mm) resulted in a decreased vibrational amplitude, ranging between 20 and 40 dB below 3 kHz. The lowest linear distortion occurred up to 10 kHz during direct contact without advancing the coupling rod.

Benefit from tonsillectomy in adult patients with chronic tonsillitis.

The objective of this study was to determine the benefits of tonsillectomy in adult patients with chronic tonsillitis with special emphasis on the influence of age and gender. Cross-sectional survey analysis of patients at least 1 year after undergoing adult tonsillectomy at a university department. We used the Glasgow Benefit Inventory and a specifically constructed illness inventory (Specific Benefits from Tonsillectomy Inventory). One hundred and nine patients completed the survey. Significant improvements were demonstrated in three out of four GBI scores ['total score' (+16.9), 'general health' (+12.9), 'physical functioning' (+46.6), all P<0.0001] and in all SBTI scores ['symptom change' (+58.3), 'reduced use of resources' (+70.9), 'general benefit' (+52.1), all P<0.0001]. Gender did not play a significant role in benefit evaluation whereby younger patients evaluated the surgery as more beneficial than older patients. Adult patients with chronic tonsillitis definitely benefit significantly from tonsillectomy. Younger adult patients perceived greater surgical benefits than older adult patients. Patient gender did not significantly influence tonsillectomy benefit evaluation.

Quality of life after unilateral acoustic neuroma surgery via middle cranial fossa approach.

CONCLUSIONS: Patients with acoustic neuroma experienced reduced quality of life (QOL) after surgery. Individual factors did not have a significant effect on QOL. In the future, QOL should be a basic factor in the outcome evaluation of different therapeutic regimens in the treatment of acoustic neuroma. OBJECTIVE: To measure the QOL of patients who underwent unilateral acoustic neuroma surgery via the middle cranial fossa approach. MATERIAL AND METHODS: The Short Form-36 (SF-36) Health Survey and a self-designed disease-specific questionnaire were used during follow-up examinations to assess health-related QOL. The pure-tone average was used to specify hearing ability. Facial nerve function was described using the House-Brackmann grading system. A total of 28 male and 14 female patients who underwent surgery between 1997 and 2001 were included in the study. RESULTS: Patients' QOL scores revealed significant reductions in QOL in comparison to normative German QOL data. Gender, age, tumor size or location and clinical symptoms such as hearing loss and restricted facial nerve function did not have an effect on QOL. The SF-36 scales physical functioning, role functioning-physical, bodily pain, general health, social functioning and role functioning-emotional demonstrated significant QOL reductions.

Surgical-handling properties of the titanium prosthesis in ossiculoplasty.

Despite the wide variety of ossiculoplasty techniques that are available, success rates are limited. Current use indicates that surgeons prefer ceramic, autograft bone, and plastic pore prostheses. During the past decade, titanium prostheses have been used with great promise. Although their use is not widespread, satisfaction rates are high. An earlier study of ossiculoplasty showed that titanium prostheses were effective in reducing conductive hearing loss. To date, the surgical-handling attributes of titanium middle ear prostheses have not been assessed. We report the results of our survey of 32 otologic surgeons who used the open Tübingen titanium prosthesis for primary and revision ossiculoplasty during tympanoplasty in 400 patients at 12 academic and nonacademic otolaryngology clinics, most of them in Germany. Because the audiometric efficacy of titanium prostheses has been previously reported, our primary outcomes measures included ease of use with respect to the amount of time required to prepare the implants for placement and the surgeons' overall impression of the intraoperative handling characteristics of the implants, taking into consideration factors such as positioning, length adjustment, visibility, and the stability of the coupling. Surgeons also compared the properties of the titanium implant with those of gold, ceramic, and autograft implants that they had used in the past. Based on the results of 383 of the 400 ossiculoplasties, our survey revealed that the titanium implant was significantly superior to the others in all measured respects.

Safe and reliable sound threshold measures with direct vibration of the ossicular chain.

OBJECTIVES: The aim of the study was to evaluate the safety and feasibility of piezoelectric malleus vibration audiometer (MVA), which presents micromechanical vibrations to the umbo membranae tympani. STUDY DESIGN: Phase I study performed in a tertiary referral center (University Hospital). METHODS: The coupling rod of the MVA was moved slowly through the outer ear canal toward the eardrum with a micromanipulator. Coupling was completed when the rod tip touched the umbo membranae tympani. Basic audiologic measures of sound threshold obtained with direct stimulation of the malleus are presented. We used MANOVA (multivariate repeated measures ANOVA) to investigate the repeatability of MVA thresholds from one day to the other and when decoupling and retracting the coupling rod 2 mm off the umbo. We also selected the MANOVA to test for unwanted bone-conduction threshold shifts after MVA application. We assessed normality of the data by quantile-quantile plots of the residuals. RESULTS: Twenty-eight male and 10 female subjects with normal hearing, 22.2 to 34.6 years old (median age, 27.2 yr) underwent an examination. Thirty-six subjects underwent MVA, because 2 of the 38 subjects who volunteered for the study have not undergone the procedure due to the external auditory canal anatomy preventing application of the MVA. The results show that it is possible to safely and reliably measure thresholds of direct vibration of the ossicular chain. Using pure tone audiograms, no pure tone bone- and/or air-conduction threshold shifts occurred after the procedure. None of the subjects reported any other ear-related symptoms such as vertigo, tinnitus, or dizziness. Geometric mean vibratory displacements at threshold ranged from 0.55 nm at 250 Hz to 0.03 nm at 6 kHz. MANOVA demonstrated a repeatability of MVA thresholds. CONCLUSION: Malleus vibration audiometry will not allow exact linkage of actual implantable hearing aid. But the present study demonstrates that MVA can provide an audiometric tool for assessing ossicular function and integrity prior to implantation of an electronic hearing amplifier.

Comparison of the implantability of electronic hearing devices in a virtual reality planning environment and in human temporal bones.

OBJECTIVE: To develop a procedure using a virtual reality (VR) environment that permitted us to simulate the preoperative fitting of an electronic implantable hearing device (IHD) and assess its implantability. MATERIAL AND METHODS: This was an experimental, prospective study based on VR simulations involving the pre- and postoperative comparison of the implantability of an IHD. The preoperative possibility of implanting an IHD in a VR environment was compared with the postoperative implantability of the device in the temporal bones of human cadavers and patients. Study groups were analyzed according to the criteria "VR implantation" and "real surgery" using contingency tables. RESULTS: A computer simulation method based on CT images was developed for the preoperative planning of the implantation. The VR simulation proved feasible in all cases (15 temporal bones and 24 patients). There was no significant difference between the process of implanting the IHD in patients or in the VR environment. These results indicate that VR-based test fittings of an IHD allow prediction of the implantability of an IHD prior to actual surgery. CONCLUSION: We have described the development of a novel VR procedure for predicting the implantability of hearing devices in otoneurosurgical applications. The VR procedure can be applied universally and may also be used for other parts of the body.

Phase III results with a totally implantable piezoelectric middle ear implant: speech audiometry, spatial hearing and psychosocial adjustment.

OBJECTIVE: To evaluate the treatment efficacy of an electromechanical middle ear amplifier implant (AI) in patients with chronic moderate-to-severe sensorineural hearing loss (SNHL). The AI is a piezoelectric system with a sound processor and a rechargeable battery within a hermetically sealed titanium canister. Its titanium-sealed microphone is placed in the bony region of the ear canal. The incus-coupled transducer (actuator), which is also inside a titanium casing, is fastened to the adjacent bone. MATERIAL AND METHODS: This was a phase III study comprising 20 intention-to-treat patients. Telemetrical adjustments followed electromechanical amplifier implantations. We used a word recognition test as our primary efficacy measure (Freiburg Speech Recognition Test: DIN 45621). Secondary efficacy measures were the sentence comprehension test (Goettinger Satztest, 1996) for auditory orientation within noisy and quiet environments and a psychosocial adjustment test (Gothenburg Profile Test, 1998). The 6-month follow-up comprised a complete medical examination. Nineteen patients completed the study (per-protocol patients; 100% reference). RESULTS: Seventeen patients (89%) demonstrated improved binaural recognition of phonetically balanced monosyllables. Fourteen postoperative patients (74%) attained a perfect score (100%) on this test, compared to only 3 preoperative patients (16%). Thirteen patients (68%) reached the sentence recognition threshold at a 2:1 dB signal-to-noise ratio during noisy trials. Correct identification of the noise source direction in the horizontal plane occurred in 89% of the trials. The Gothenburg Profile Test scores showed that the subjective evaluation of hearing, orientation, social behavior and self-confidence increased from 48% to 88%. Three patients did not benefit from the implant. CONCLUSION: Treatment of SNHL with a totally implantable hearing system can be an efficient method for those patients unable to wear hearing aids. However, in order to avoid implantation in non-responders, there is a need for more specific audiological indication criteria.

How safe is percutaneous ethanol injection for treatment of thyroid nodule? Report of a case of severe toxic necrosis of the larynx and adjacent skin.

OBJECTIVE: Since 1990, percutaneous ethanol injection therapy (PEIT) has been clinically applied as a treatment for autonomous functioning nodules of the thyroid as well as for cystic lesions. Some additional indications are currently under consideration, e.g. inoperable advanced cancer of the thyroid. Since its inception, PEIT has generally been regarded as an effective, low-risk, inexpensive procedure which can be performed on an ambulatory basis. MATERIAL AND METHODS: We report the first case of severe ethyl toxic necrosis of the larynx combined with necrotic dermatitis in a patient treated with PEIT by a radiologist. RESULTS: The patient was admitted to hospital, where the necrosis and dermatitis were treated conservatively. A cyst which developed in the right false vocal fold was removed by microsurgery 10 months later. Voice was restored almost to normal but a significant reduction in nodular volume was not seen, probably due to the inexperience of the operator. CONCLUSION: PEIT for functional thyroid gland autonomy is an inexpensive method of treating hyperthyroidism with focal autonomy on an ambulatory basis if surgical intervention and radioiodine therapy are not feasible either for medical reasons or because of refusal by the patient. Severe complications must be taken into consideration and discussed with the patient. To avoid complications, substantial experience and a precise ultrasound-guided injection are required. In the case of complications the opinion of a specialist should be sought at anearly stage.

Patient selection for incus body coupling of a totally implantable middle ear implant.

OBJECTIVE: To evaluate audiologic selection criteria for incus body coupling (IBC) of a totally implantable middle ear implant (TI-MEI) for the treatment of sensorineural hearing loss (SNHL). MATERIAL AND METHODS: The protocol is specified in the Investigational Device Exemption of a Food and Drug Administration-approved multicenter clinical trial. The prospective study compared pre- and postoperative hearing levels using each patient as their own control. In addition, an implant on/off comparison was made. All patients had a follow-up interval of at least 6 months. Audiologic assessment tests included speech discrimination in quiet as the primary efficacy variable and pure-tone audiometry (aided thresholds), gain, speech recognition in noise and subject satisfaction using standardized questionnaires and visual analog scales (VASs) as secondary efficacy variables. The study group of patients (n = 13) was divided into 3 subgroups based on their pure-tone and speech discrimination scores: Group A consisted of 6 patients, Group B 9 patients and Group C of all 13 patients. All patients suffered from long-standing bilateral moderate to severe SNHL. Five patients were dissatisfied hearing aid (HA) users and eight subjects could not wear HAs. All patients were implanted with a TI-MEI which was coupled to the incus body. The amplification level of the device was set postoperatively using inductive digital fitting based on "most comfortable loudness" specifications. RESULTS: The implant produced median improvements from 30% (optimally fit bilateral HAs; n = 5) and 50% (HA non-users; n = 8) to 70% word recognition at 60 dB SPL. Average word recognition scores at 60, 80 and 90 dB SPL in Groups A and B showed increases from 42% (interquartile range +27%, -12%) to 93.5% (+3%, -5%) and 92.5% (+3%, -7%), respectively. In the presence of background noise, the sentence recognition threshold ranged from -2 to 1 dB signal-to-noise ratio. Maximum amplification was 50 dB at 3 kHz and 55 dB at 4 kHz. In Groups A and B, VASs revealed improvements in both natural sound impression and clarity from 62-70% of a natural sound impression to maximum scores of 100%. Using the standardized Gothenburg profile, subjective evaluations of hearing, orientation, social behavior and self-confidence reached 96-98%, 92-96% and 84-92% of the maximum score for Groups A-C, respectively. CONCLUSIONS: In selected cases, IBC of the TI-MEI investigated herein may be indicated for the treatment of SNHL, provided the following four conditions are met. First, the patient does not derive sufficient benefit from conventional HAs. Second, the specific indication for IBC is restricted to situations that do not allow the coupling of the MEI to the long incus process (e.g. due to an anatomical variation of facial nerve location). Third, IBC is restricted to patients with a steeply sloped moderate to severe high frequency SNHL, amounting to 90 dB HL from 3 to 8 kHz. Patients with low frequency SNHL should not be operated on with the IBC technique, as maximum low frequency hearing loss at 0.5 kHz must not exceed 30 dB. Fourth, Schueller's X-ray should reveal normal mastoid pneumatization. Being restricted to a 6-month follow-up period, this paper provides early clinical results and no clinical evidence of long-term efficiency of the implant.

A patient database application for Hereditary Deafness Epidemiology and Clinical Research (H.E.A.R.): an effort for standardization in multiple languages.

One of the most challenging and neglected issues in medicine is the effective recording of the data obtained from the patients. The "European Work Group on the Genetics of Hearing Impairment," which has been working since 1996, proposed a few questionnaires to collect data regarding the phenotype, ENT findings, audiological examination findings and other special investigations. In this study, a computerized patient database application named "Izmir H.E.A.R version 1.0," written in Delphi 4.0 for Windows for recording the patients with hearing problems, is presented. The application consists of a modular form, including information about identity, genetic condition, proband query, audiology and vestibular tests, phenotype, pedigree and special examinations, which allows data entry on all these issues. It has been developed by using the guidelines of Hereditary Deafness Epidemiology and Clinical Research (H.E.A.R.) and by the experience gained within the last 10 years by the authors. The target population of the program is the ENT clinicians, audiologists, epidemiologists, geneticists and researchers in the field. The main idea is to create a program serving the needs of both the daily routine work and research purposes and to distribute this program to the above-mentioned specialists, to encourage them to try the first version and to find a standard and/or better way to collect data. For this reason, the program aims to be multilingual, and the currently available languages are English, German, Spanish and Turkish.

Automated registration of partially defective surfaces by local landmark identification.

OBJECTIVE: In computer- and robot-assisted surgery, the term "registration" refers to the definition of the geometrical relationship between the coordinate system of a surgical planning system and that of the patient. Within the context of the development of a navigation and control system for computer- and robot-assisted surgery of the lateral skull base, it was desirable to realize an algorithm for automated registration of partially defective surfaces that is reliable and suitable for use in clinical practice. MATERIALS AND METHODS: A registration algorithm based on the use of local fingerprints for specific points on a surface (so-called "spin images") was developed. Anatomical patient landmarks were identified automatically and assigned to CT data, performing a cross-correlation analysis and an investigation of the geometrical consistency. The algorithm was evaluated within the development of the navigation and robotic control system in a laboratory setting. RESULTS: Under laboratory conditions it could be shown that partially defective surfaces (simulated by, for example, adding white noise, or reducing or smoothing the polygon data) were correctly recognized and thereby registered. In particular, the algorithm proved its excellence in interpreting partially modified topologies. CONCLUSIONS: The proposed procedure can be used to accomplish dynamic intra-operative registration of the skull bone by the generation of point relations to the CT images.