New method for in-office secondary voice prosthesis insertion under local anesthesia by reverse puncture from esophageal lumen.

OBJECTIVES: We clarify and demonstrate the utility of our new method of voice prosthesis insertion using puncture from the esophageal lumen. METHODS: Our new reverse puncture method using a flexible endoscope can be performed in an outpatient clinic under local anesthesia. We conducted a clinical trial with patients with head and neck cancer between April 2010 and February 2012. Our study focused on the following three points: 1) the percentage of patients for whom the procedure was successful; 2) the duration of the operation; and 3) any adverse effects. RESULTS: The puncture was performed successfully for 21 of 22 patients (95%). The mean duration of the operation, excluding the time for local anesthesia, was only 11.6 minutes. All patients began voice rehabilitation and attained peroral intake immediately after the operation. None of the patients suffered complications from the procedures. CONCLUSIONS: Most patients were treated with our new method with ease and at low risk. The high success rate and the absence of complications demonstrate the benefits of our method. We conclude that our method can be recommended for secondary reverse tracheoesophageal puncture.

Prevention of voice prosthesis biofilms: current scenario and future trends in prolonging prosthesis lifetime.

Voice rehabilitation after a total laryngectomy is an important requisite for patients' rehabilitation. Oesophageal speech using tracheo-oesophageal-valved prostheses is now considered the state-of-art in postlaryngectomy voice rehabilitation. One of the major drawbacks of voice prostheses is their limited device lifetime. This is due to the deterioration of the silicone rubber material by different bacterial and yeast species, which are organised in the form of a biofilm resulting in internal leakage, increased airflow resistance, impeding speech, respiration and swallowing. The use of antimicrobials though easily applicable is associated with development of resistance if used on long-term basis. Other techniques in the form of modification of physicochemical properties of the silicon surface or covalent binding of antimicrobial agents to the silicon surface have been employed. This article reviews the different strategies investigated until now and the future trends in preventing biofilm formation for prolonging the lifetime of the silicon voice prostheses. Data was collected by conducting a computer aided search of the MED-LINE and PUBMED databases, supplemented by hand searches of key journals. Over 35 articles in the last two decades on the topic have been reviewed out of which 27 were found to be of relevant value for this article.

The voice handicap index with post-laryngectomy male voices.

BACKGROUND: Surgical treatment for advanced laryngeal cancer involves complete removal of the larynx ('laryngectomy') and initial total loss of voice. Post-laryngectomy rehabilitation involves implementation of different means of 'voicing' for these patients wherever possible. There is little information about laryngectomees' perception of their changed voice quality and communication status. Surgical voice restoration (SVR) has become the 'gold standard' rehabilitation, but there continue to be patients who use other methods of communication. There is no clear evidence comparing patients' perception of their voice handicap across different types of alaryngeal communication. AIMS: To compare the self-assessed vocal handicap of laryngectomees using SVR with those using non-SVR methods of post-laryngectomy communication. METHODS & PROCEDURES: Potential participants were identified from one Head and Neck cancer centre in South Wales. They included both male and female participants using all methods of post-laryngectomy communication. Each patient's Voice Handicap Index (VHI) score, sub-set scores, and group means were calculated. Two major confounding factors: age and time since surgery, and communication method (SVR/non-SVR), were considered to identify factors, other than method of communication, which may influence rehabilitation outcomes. OUTCOMES & RESULTS: A total of 71 questionnaires were sent out and 62 (82%) were returned from 35 patients who had undergone SVR and 27 patients who used non-SVR methods of communication. Of the non-SVR group, twelve used oesophageal voice, eleven an electrolarynx, two writing and two mouthing for communication. The gender ratio (53:9), age (43-90 years) and time since surgery (1-40 years) were broadly representative of this population, but because of the small number of females, we excluded the women from further analysis. Individual VHI scores ranged from 4 to 106. Both the SVR and non-SVR group mean scores: 44.7 and 50.9, were within the range of moderately severe voice handicap. There was no significant difference between the groups for total VHI scores or two of the three sub-domains, nor any significant effect on voice handicap due to the confounding factors assessed: age or time since surgery. The total VHI score was better by 6.5 ( - 4.9 to 17.9) points in the SVR group (p = 0.3), probably reflecting the literature reporting superior voice in SVR. CONCLUSIONS & IMPLICATIONS: The data suggest that where patient-assessed quality of life is concerned, SVR and non-SVR outcomes are comparable. This is an important consideration when planning and carrying out treatment recommendations. The study has clear clinical implications; understanding the potential of all methods of post-laryngectomy communication is essential for holistic patient management.

Electromyographic control of a hands-free electrolarynx using neck strap muscles.

UNLABELLED: Three individuals with total laryngectomy were studied for their ability to control a hands-free electrolarynx (EL) using neck surface electromyography (EMG) for on/off and pitch modulation. The laryngectomy surgery of participants was modified to preserve neck strap musculature for EMG-based EL control (EMG-EL), with muscles on one side maintaining natural innervation and those on the other side receiving a transferred recurrent laryngeal nerve (RLN). EMG from each side of the neck controlled the EMG-EL across a day of unstructured practice followed by a day of formal training, including EMG biofeedback. Using either control source, participants spoke intelligibly and fluently with the EMG-EL before formal training. This good initial performance did not consistently improve across testing for either control source in terms of voice timing, speech intelligibility, fluency, and intonation of interrogative versus declarative sentences. Neck strap muscles have activation patterns capable of simple alaryngeal voice control without requiring RLN transfer. LEARNING OUTCOMES: The reader will better understand (1) functionality of the hands-free electrolarynx (2) modification of laryngectomy surgery to preserve neck strap musculature and (3) performance of hands-free electrolarynx with different control sources.

Closure of tracheoesophageal fistula with prefabricated revascularized bilaminar radial forearm free flap.

BACKGROUND: Tracheoesophageal fistula (TEF) is a rare but serious complication associated with high mortality rates. Traditional management of TEF includes primary closure with or without interposition of regional tissue flaps but is associated with a significant recurrence risk, especially in case of larger fistulas. Application of microvascular free flap reconstruction is an emerging alternative in the surgical management of large TEFs, but may be limited by issues of flap bulkiness and requirement for neoepithelialization across the large inner flap surface. METHODS AND RESULTS: Here, we report prefabrication of a bilaminar radial forearm free flap to successfully close a large recurrent TEF that occurred years after tracheoesophageal puncture-based voice rehabilitation in a laryngectomized patient. CONCLUSION: The bilaminar radial forearm free flap may prove to be an important adjunct to the closure of large TEFs.

Safe and simple method for secondary tracheoesophageal puncture using curved forceps.

INTRODUCTION: Secondary tracheoesophageal puncture is sometimes difficult and has a higher complication rate. In the irradiated neck, where neck extension is difficult, the traditional tracheoesophageal puncture method of insertion with a rigid endoscope is not possible. We describe a simple, safe and effective alternative method of tracheoesophageal puncture using curved forceps (Kocher's curved intestinal clamp forceps or Mixter forceps). SURGICAL TECHNIQUE: The procedure is performed under local or general anaesthesia with equal ease. Maximum neck extension is achieved. The curved intestinal forceps are passed through the mouth into the oesophageal lumen. The instrument tip can easily be seen or felt at the posterior wall of the tracheostoma. A small incision is made in the mucosa to allow the forceps tip to emerge, and a guide wire is passed through this incision out of the mouth. The prosthesis can be guided over the guide wire, in retrograde fashion, to fit the puncture hole. RESULTS: Secondary tracheoesophageal puncture was performed in five cases with severe neck fibrosis. In all cases, valve insertion was easily achieved after secondary tracheoesophageal puncture, without any peri-operative complications. CONCLUSION: This is a safe, simple and effective method for secondary tracheoesophageal puncture. It can be performed easily in any setting and is not associated with any complications.

A thin tracheal silicone washer to solve periprosthetic leakage in laryngectomies: direct results and long-term clinical effects.

OBJECTIVES: Assessment of the immediate results and long-term clinical effects of a thin silicone washer placed behind the tracheal flange of voice prostheses to treat periprosthetic leakage. PATIENTS AND METHODS: Three year retrospective analysis of 32 laryngectomized patients with 107 periprosthetic leakage events (PLEs). Custom-made silicone washers (outer diameter 18 mm, inner diameter 7.5 mm, thickness 0.5 mm) were placed behind the tracheal flange either in combination with prosthesis replacement or later. RESULTS: There was immediate resolution of periprosthetic leakage in 88 PLEs (median, 38 d; mean, 53 d; range, 8-330 d) and in 6 PLEs with the washer still in situ at the date of analysis (median, 75; mean, 97 d; range, 38-240 d). There was no resolution for periprosthetic leakage in 13 PLEs. Thus, in total, 94 of 107 PLEs (88%) were successfully resolved. In 29 of 32 (91%) patients, the washer resolved the problem at least in one PLE successfully. Twelve of 32 patients, including all 3 with washer failures, also required other interventions to ultimately solve the problem. The vast majority of patients (80%) did not consider placement of the washer to be inconvenient. CONCLUSIONS: In consideration of the high success rate and limited inconvenience for patients, this simple thin silicon washer application provides a good first option for the treatment of periprosthetic leakage.

Secondary shunt procedure for alaryngeal patients in an outpatient clinic.

The shunt procedure used for laryngectomized patients undergoing secondary tracheo-esophageal (T-E) puncture is inconvenient and causes stress to the patient. In order to overcome these problems we developed a novel surgical T-E shunt technique using the Groningen voice prosthesis that does not require esophagoscopy or general anesthesia and can be performed in an outpatient clinic. In this procedure, a shunt is created using a pair of nasal forceps with the patient seated. An endoscope with biopsy forceps is used to insert the Groningen voice prosthesis. The procedure is usually completed within 20 min after inducing local anesthesia. Neither the technique itself nor the time taken to complete the procedure differed for T-E and tracheo-neoesophageal (reconstructed with flap) shunting. We believe that this procedure is suitable for patients who are afraid of esophagoscopy and/or are not considered suitable candidates for esophagoscopy and repeated general anesthesia. The procedure is also beneficial for both patients and surgeons with regard to its duration and the cost-effectiveness of treatment.

Colonization of voice prostheses by albicans and non-albicans Candida species.

OBJECTIVES: The purposes of the study were to assess the colonization of tracheoesophageal voice prostheses by albicans and non-albicans Candida species and to determine their susceptibility for three antimycotics that are frequently used for prophylaxis or treatment of oral candidiasis (i.e., miconazole, fluconazole, and nystatin). STUDY DESIGN: In total, 101 patients, corresponding to 170 voice prostheses, were monitored over a period of 28 months. METHODS: An enzymatic two-step method was used for differentiation and presumptive identification of Candida species colonizing the voice prostheses. The identity of the isolates was confirmed by the germ-tube test, morphological appearance on cornmeal agar with 0.5% Tween 80, sugar assimilation tests, and appearance on CHROMagar Candida (CHROMagar Co., Paris), Albicans ID (BioMérieux Vitek, Hazelwood, MO), and Fluoroplate Candida (Merck, Darmstadt, Germany). Susceptibility testing for miconazole, fluconazole, and nystatin was performed according to the microdilution method of the National Committee for Clinical Laboratory Standards. RESULTS: The predominant species isolated were Candida albicans (41.4%), Candida glabrata (33.1%), Candida krusei (15.9%), and Candida tropicalis (5.3%). A broad range of minimal inhibitory concentrations of the isolates was observed for miconazole and fluconazole. In contrast, minimal inhibitory concentration values for nystatin were narrowly distributed around 4 microg/mL for all isolates, suggesting uniform sensitivity. CONCLUSION: Our data on the prevalence and susceptibility of yeast isolates will contribute to a rational choice of an antimycotic for prophylaxis of the early deterioration and leakage of tracheoesophageal voice prostheses.

Secondary tracheoesophageal puncture with local anesthesia.

OBJECTIVES: To present a new technique for secondary tracheoesophageal puncture (TEP) in laryngectomized patients. The technique is performed on an outpatient basis under local anesthesia. STUDY DESIGN: Laryngectomized patients waiting for secondary TEP procedures were given the choice between the new technique under local anesthesia on an outpatient basis and the traditional technique under general anesthesia requiring hospitalization. METHODS: Using basic implements available in an outpatient clinic, the traditional TEP technique was modified with the oral introduction of an intubation tube with an illuminated, inflatable cuff at the puncture site. The illuminated, inflated cuff serves as a beacon during the procedure and the tube protects the posterior tracheal wall. RESULTS: Nine patients underwent the procedure under local anesthesia. In 8 of them the procedure went smoothly, but in 1 of them the inflatable cuff could not be satisfactorily placed as a result of the local anatomy and the procedure was canceled. All patients were pleased with the technique and said the procedure was painless. CONCLUSIONS: With some modifications, the traditional TEP technique has been rendered suitable for selected outpatient use under local anesthesia, and the necessary hospitalization for secondary TEP can thus be avoided.

Tracheoesophageal puncture in the office setting with local anesthesia.

Tracheoesophageal puncture (TEP) with voice prosthesis placement is currently the method of choice for vocal rehabilitation of patients who have undergone total laryngectomy. Occasionally, secondary TEP needs to be performed. We have used a TEP technique that is performed in the clinic setting with local anesthesia and no sedation. The purpose of this study was to review our technique and experience and to evaluate results, complications, and patients' acceptance of the procedure. We performed a retrospective chart review of the records of 14 patients who had undergone total laryngectomy and secondary TEP placement in the clinic setting. The procedure was well tolerated. The voice results were fair to good in 11 of 12 patients. There was 1 complication, a false passage between the trachea and the esophagus. Voicing was immediate in 12 of the 14 cases. We conclude that TEP can be performed in the office setting with local anesthesia. The voice results are excellent, and the procedure is well tolerated by the patient. Proper patient selection and regular follow-up by a speech-language pathologist are important.

In vitro formation of oropharyngeal biofilms on silicone rubber treated with a palladium/tin salt mixture.

Adhesion of yeasts and bacteria to silicone rubber is one of the first steps in the biodeterioration of indwelling, silicone rubber voice prostheses. In this paper, silicone rubber, so-called "Groningen button," voice prostheses were treated with a colloidal palladium/tin solution to form a thin metal coat intended to discourage biofilm formation. First it was demonstrated that this treatment did not negatively affect the airflow resistance of the prostheses or induce any cytotoxicity. Subsequently, palladium/tin-treated voice prostheses were placed in a modified Robbins device together with untreated control prostheses to evaluate biofilm formation. Biofilms were formed by inoculating the device for 3 days with the total cultivable microflora obtained from an explanted, malfunctioning voice prosthesis supplemented with separately isolated yeasts (Candida albicans and Candida tropicalis). After 3 days the device was perfused three times daily with growth medium and phosphate-buffered saline. The device was allowed to drain between perfusions to better mimic the conditions in the oropharynx (moist but not always fully wetted). After 9 days the total number of bacterial and fungal colony-forming units on the prostheses were determined microbiologically, and scanning electron micrographs were taken of the valve sides. Biofilm formation was significantly less on the heavily treated palladium/tin prostheses than it was on the untreated prostheses although some ingrowing microcolonies also were observed on the treated prostheses. The spread of the biofilms was smaller on the treated prostheses than on the untreated ones.

[Hydromassage of wound surface of surgically reconstructed laryngeal lumen and upper trachea]. / "Gidromassazh" ranevoi poverkhnosti vosstanavlivaemogo khirurgichskim putem prosveta gortani i verkhnei chasti trakhei.

In surgical reconstruction of laryngostenosis and stenosis of the upper trachea after dissection of the scars we place laryngotracheal prosthesis (LTP) in the created lumen for a year and longer. The LTP dilator prevents regrowing the scars into the larynx and trachea until termination of the wound epithelization. The author has designed a device which provides a pulsed change in the pressure of water-filled latex balloon-dilator of the LTP. This pulsed work is realized by 7-8-s sucking out water and filling again of 1/3 of water volume in the dilator. Such procedures lasting for 20-30 min conducted 2 times a day are called hydromassage of the larynx and trachea. In 7 patients subjected to hydromassage for a full time of wearing the LTP, epithelization of the wound surface of the reconstructed part of the airways occurred within 2-2.5 months. If hydromassage was performed for half the time of LTP wearing (12 patients) epithelization occurred within 3-3.5 months.

[Replacement of tracheo-esophageal Provox prosthesis]. / Remplacement de l'implant phonatoire Provox: anesthésie locale ou anesthésie générale?

OBJECTIVES: To compare anesthesic techniques used between 1992 and 1997 at Laënnec Hospital for replacement by tracheo-esophageal Provox prosthesis: local and general anesthesia. Theoretical financial cost for replacement was estimated according to anaesthetic techniques. PATIENTS AND METHODS: Provox in situ lifetime was calculated in 58 patients who underwent 115 and 49 replacements under general and local anaesthesia respectively. Age, sex, surgical and radiotherapy backgrounds, complications and anaesthetic techniques were studied as potential factors correlated with Provox in situ lifetime. Theoretical financial cost for replacement was estimated according to anaesthetic techniques. RESULTS: In 1992, 12% of Provox prosthesis were inserted under local anaesthesia and 54% in 1997. Provox in situ lifetime was either not influenced by anaesthetic techniques or other factors under analysis. The theoretical financial cost was estimated at 14, 341 FFrs and 6,048 FFrs for replacement under general and local anaesthesia respectively. CONCLUSION: Due to increased control of health care costs, we advocated local anaesthesia for Provox prosthesis replacement if control endoscopy is not required.

Multi-institutional assessment of the Provox 2 voice prosthesis.

OBJECTIVES: To verify the initial results of a new anterograde replacement method of the second-generation indwelling Provox voice prosthesis, Provox 2 (Atos Medical AB, Hörby, Sweden), and to determine its device life. DESIGN: Nonrandomized, multi-institutional, controlled clinical trial. SETTING: Four academic hospitals and/or comprehensive cancer centers in The Netherlands. PATIENTS: Two hundred thirty-nine consecutive patients who had undergone laryngectomy and were visiting the outpatient clinic for replacement of their voice prosthesis. INTERVENTION: Anterograde replacement of the Provox 2 voice prosthesis. MAIN OUTCOME MEASURES: Evaluation of ease of use by the medical professional and appreciation by the patients, by means of structured questionnaires; comparison of device life between the original Provox and the new Provox 2 voice prosthesis in a subset of patients. RESULTS: Voice prostheses replaced were Provox (n = 188), Groningen (Medin, Groningen, The Netherlands) (n = 47), and Nijdam (Medin) (n = 4). Anterograde replacement of Provox 2 was always possible. The new anterograde method was preferred by the medical professionals in 97.1% of cases and by 93.7% of the patients, who reported significantly reduced discomfort (P<.001). There was no significant difference in device life between Provox and Provox 2 (median, 125.5 and 104 days, respectively). In 57.5% of patients, the Provox 2 device life was shorter and in 42.5% it was longer (sign test, P = .09). CONCLUSIONS: The results of the initial study concerning ease of use for the medical professionals and decreased discomfort for the patients of the new anterograde replacement procedure of the Provox 2 prosthesis were confirmed. The device life of Provox and that of Provox 2 were comparable, despite the alterations needed to optimize the Provox 2 prosthesis for the anterograde procedure.

Electrocortical and heart rate response during vibroacoustic stimulation in fetal sheep.

OBJECTIVE: Our purpose was to study effects of vibroacoustic stimuli on electrocortical activity and heart rate changes in fetal sheep in utero. STUDY DESIGN: Seven chronically instrumented near-term fetal sheep were repeatedly stimulated by an electronic artificial larynx for 32 seconds during periods of rapid-eye-movement and non-rapid-eye-movement sleep. Responses to vibroacoustic stimulation were obtained by spectral analysis of the electrocorticogram (fast Fourier transform) and by assessment of changes in fetal heart rate and fetal heart rate variability. RESULTS: During non-rapid-eye-movement sleep vibroacoustic stimulation led to electrocorticogram desynchronization that consisted of a marked reduction of delta and theta band power (p < 0.05). A concomitant fetal heart rate decrease and fetal heart rate variability increase were also noted (p < 0.05). During rapid-eye-movement sleep vibroacoustic stimulation induced a significant increase in alpha and beta band power (p < 0.05) and a slight deviation in basal fetal heart rate and fetal heart rate variability (p < 0.05). CONCLUSION: Vibroacoustic stimulation of fetal sheep provokes reproducible changes in fetal electrocortical activity and heart rate patterns. These changes, which are not easily identifiable in gross polygraphic assessments of the fetal behavioral state, are indicative of fetal arousal.

Flexible endoscopic tracheo-oesophageal puncture under local anaesthetic.

Blom-Singer valve prosthesis is an increasingly popular technique for voice rehabilitation in alaryngeal patients. Although primary voice puncture is being practised, the creation of the tracheo-oesophageal fistula is performed in the majority of patients as a secondary procedure. We describe a technique of secondary tracheo-oesophageal puncture using the flexible endoscope which can be performed under local anaesthetic and sedation. The technique overcomes the difficulty of passing a rigid oesophagoscope or forceps to the level of the tracheostome in a scarred and irradiated neck. The new technique also obviates the need for general anaesthesia. We have successfully used the technique in three patients.

Technique of tracheo-oesophageal puncture under local anaesthesia.

Various techniques for performing a secondary tracheo-oesophageal puncture to enable insertion of a speech prosthesis in laryngectomized patients have been described. We describe a modification that allows a safe secondary tracheo-oesophageal puncture under local anaesthesia using standard equipment available in an ENT department.

[Secondary ambulatory voice prosthesis implantation with the argon laser using local anesthesia]. / Sekundäre ambulante Stimmprothesen-Implantation mit Argon Laser in Lokalanästhesie.

An alternative technique for secondary tracheo-esophageal puncture and voice prosthesis implantation in topical anesthesia on an outpatient basis was developed. With argon laser beam passed through a glass fibre in the instrument channel of a flexible endoscope a secondary puncture of the tracheo-esophageal wall is obtained. A voice prosthesis is fitted subsequently, so that the whole operation is performed in one session in about 30 minutes. We generally administer 7.5 mg Midazolam orally for light sedation; antibiotics are not required. This method expands the possibility of voice prosthesis fitting in patients who are not considered or willing to have general anesthesia for various reasons. In 33 cases we did not see any complication. In two cases the tracheal wall was too tight due to radiation therapy, so that an operation had to be performed later on in general anesthesia. In one case technical problems led to an operation in local anesthesia in two steps. In all cases the patients did not complain of any considerable discomfort.