Annemieke H. Ackerstaff

Development and Clinical Evaluation of a Second-generation Voice Prosthesis (Provox®2), Designed for Anterograde and Retrograde Insertion

Prosthetic voice restoration has considerably improved the results of vocal rehabilitation after total laryngectomy, and is presently the method of choice for many health-care providers treating laryngectomized patients. The Provox voice prosthesis, developed in the Netherlands Cancer Institute, is an indwelling device that has been applied in recent years with regular success. Its retrograde replacement method, using a disposable guide wire, assures reliable, atraumatic positioning of the prosthesis in the tracheoesophageal fistula. However, the method sometimes may be uncomfortable for the patient; therefore an adapted prosthesis and new replacement equipment were developed, which enable bidirectional insertion, i.e. not only in the traditional retrograde manner through the pharynx, but especially in an anterograde manner through the stoma. This second-generation voice prosthesis (Provox 2) was studied in a prospective clinical trial in 44 patients (33 experienced patients, seven first-time replacements and four primary insertions). The study demonstrated that the anterograde insertion with the Provox 2 system was applicable in all patients, making the voice prosthesis even easier to handle than with the traditional retrograde method. A stenosis of the pharyngoesophageal segment no longer interfered with the replacement. In addition, the patients judged the new method as being favourable, reporting significantly less discomfort during the replacement procedure (paired Students t-test: p < 0.0001). Furthermore, the adapted voice prosthesis could be removed from the tracheoesophageal fistula without excessive force (mean 7.9 N, range 6.0-14.0 N), more easily than the original Provox (mean 20.9 N, range 5.5-25.0 N). It can be concluded that this second-generation indwelling voice prosthesis (Provox 2) seems to be a further improvement in the application of this voice rehabilitation system, not only simplifying the replacement procedure, but also diminishing the discomfort for the patient.

Improvements in respiratory and psychosocial functioning following total laryngectomy by the use of a heat and moisture exchanger.

A prospective clinical study in 61 patients was undertaken to investigate the subjective and objective influence of a heat and moisture exchanger (HME) on the respiratory and psychosocial problems following total laryngectomy. Although statistical comparisons failed to detect significant differences between the experimental and the control groups, there was a clear trend toward improvements in respiratory and psychosocial functioning in the experimental group. Analyses of differences over time within the HME user group showed significant reductions in the incidence of coughing, the mean daily frequency of sputum production, forced expectoration, and stoma cleaning. Significant improvements were also found in shortness of breath, fatigue and malaise, sleep problems, levels of anxiety and depression, and perceived voice quality. Pulmonary function tests showed significant improvements in inspiratory flow and volume values following use of the HME. This objective improvement in inspiratory pulmonary function reflects the decrease in sputum production reported by the patients.

High-dose superselective intra-arterial cisplatin and concomitant radiation (RADPLAT) for advanced head and neck cancer.

The purpose of this study was to study the effect of intensive targeted chemoradiation in a group of patients with head and neck cancer with stage IV inoperable disease.

Development and clinical assessment of a heat and moisture exchanger with a multi-magnet automatic tracheostoma valve (Provox FreeHands HME) for vocal and pulmonary rehabilitation after total laryngectomy

Objective--To develop and test the prototypes of a novel post-laryngectomy rehabilitation tool incorporating an obligatory, disposable heat and moisture exchanger (HME) and a reusable, multi-magnet automatic speaking valve (ASV).Material and methods--The study subjects comprised 20 laryngectomized individuals (15 males, 5 females), 5 of whom were already using an ASV and 15 who were not. Three successive prototypes were tested. Data were collected by means of structured questionnaires, considering for example patient compliance, skin adhesion, voicing and coughing aspects, and voice and speech quality assessments, assessing for example maximum phonation time and dynamic loudness range.Results--Of the 15 non-ASV users, 5 did not comply with the study due to peristomal skin adhesion problems. Of the remaining 15 patients, all 5 ASV users and 6/10 non-users were fully compliant with the new device. The cough-relief valve of the new device functions properly, as does the valve position adjustment for physical exertion. With this new device the maximum phonation time was longer than with a regular ASV (15.2 vs 11.6 s; p=0.006) and the dynamic range was larger (33.0 vs 24.8 dB; p<0.001).Conclusion--The test results obtained with this new device show that its advanced features (obligatory HME and multi-magnet valve systems) offer additional benefits for further improving vocal and pulmonary rehabilitation after total laryngectomy.

FIRST-YEAR QUALITY OF LIFE ASSESSMENT OF AN INTRA-ARTERIAL (RADPLAT) VERSUS INTRAVENOUS CHEMORADIATION PHASE III TRIAL

We report the results of a multicenter randomized phase III study, assessing quality of life (QOL) in intra‐arterial (IA) versus standard intravenous (IV) chemoradiation in advanced head and neck cancer.

Quality of life assessment in laryngectomized individuals: do we need additions to standard questionnaires in specific clinical research projects?

Objectives:  To assess, whether the EORTC questionnaires QLQ‐C30 and QLQ‐H&N35 give enough detailed information to study specific quality of life (QoL) related issues in laryngectomized individuals.

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.

Comprehensive Rehabilitation after Total Laryngectomy Is More than Voice Alone

Comprehensive rehabilitation after total laryngectomy is more than voice alone. The removal of the larynx and the subsequent disconnection of the upper and lower airways not only has consequences for the vocal function but also for the respiratory system, and for the olfactory acuity of the patient. The results of the research program on these three subjects in the Netherlands Cancer Institute over the last 12 years are discussed in detail along with some of the relevant other literature on the topics. The considerable progress in these areas over the last 2 decades has clearly improved the quality of life of laryngectomized patients.

The influence of stoma occlusion on aspects of tracheoesophageal voice

In this study, speech of 21 laryngectomized patients is investigated under 2 different stoma occlusion conditions, i.e. direct digital occlusion of the stoma (by thumb or finger), and digital occlusion (by finger) via a special heat and moisture exchanger with speech valve (Provox Stomafilter). For both conditions, acoustical analyses of voice quality (various pitch, amplitude, tremor and harmonicity measures) were performed on a sustained /a/, the mean maximum phonation time was calculated, and a phonetogram was made. Acoustical analysis was possible in 13 of the 21 voices (for the other voices, the pitch was too low or the voice was too aperiodic), but no statistical significant differences were found for any of the acoustical parameters studied. However, the maximum phonation time was significantly longer, and the dynamic range significantly larger, under the Stomafilter occlusion condition. The maximum phonation time showed a relevant improvement in 57% of the patients, while the dynamic range showed a relevant improvement in 35% of the patients. In total, 75% of the patients experience an improvement in one or both of these speech characteristics when using the Stomafilter occlusion. It can be concluded that optimal stoma occlusion by means of a specialized device has a positive influence on two relevant parameters of prosthetic voice production: maximum phonation time and dynamic loudness range.

Compliance, quality of life and quantitative voice quality aspects of hands-free speech

Conclusions With the use of a new automatic stoma valve (ASV) it appears possible to rehabilitate patients who have previously been unsuccessful in acquiring hands-free speech. As well as making daily ASV use possible for an additional group of patients, this new device was also appreciated by many patients as an additional rehabilitation tool for specific occasions. Despite statistically significant improvements in aspects of voice and breathing using this novel ASV, improvement of peristomal adhesion is probably the main factor needed to further increase success rates. Nevertheless, our results show that it makes sense to keep trying to achieve hands-free speech, even if previous attempts have failed. Objective To make a long-term (6 months) assessment of compliance and aspects of voice, breathing and quality of life using a new ASV: the Provox FreeHands heat and moisture exchanger (HME). Material and methods This was a prospective clinical multicentre trial in 79 laryngectomized patients (8 regular ASV users, 58 previously unsuccessful users and 13 new users). Data were collected at baseline and after 1 and 6 months by means of European Organization for Research and Treatment of Cancer Quality of Life questionnaires and specific structured questionnaires concerning compliance, skin adhesion, voicing and pulmonary aspects. An objective assessment of voice parameters (maximum phonation time, maximum phonation time while counting, dynamic loudness range and number of pauses in a standard read-aloud text) was made for comparison of different stoma occlusion methods (digital occlusion via an HME and two different ASVs). A subjective assessment of overall voice quality was made. Results After 6 months, 19% of patients used the new ASV on a daily basis (mean 5 h/day), while 57% used it on an irregular basis as an additional rehabilitation tool for special occasions. Two-thirds of the study group indicated that they would continue to use the new ASV after the study period. With respect to the objective parameters, statistically significantly better maximum phonation times and dynamic loudness ranges were observed with the new ASV compared to the Blom–Singer ASV. However, the best results for all the objective parameters were obtained with digital occlusion via the Provox HME.