The effect of a Heat and Moisture Exchanger (Provox® HME) on pulmonary protection after total laryngectomy: a randomized controlled study

The goal of this randomized controlled study was to investigate the effect of Heat and Moisture Exchanger use on pulmonary symptoms and quality of life aspects in laryngectomized patients. Eighty laryngectomized patients were included and randomized into an HME and Control group. The effect of the HME was evaluated by means of Tally Sheets and Structured Questionnaires. The results showed a significant decrease in the frequency of coughing, forced expectoration, and stoma cleaning in the HME group. There were trends for the prosthetic speakers to report more fluent speech with the HME and for the HME group to report fewer sleeping problems. In conclusion, this study, performed in Poland, confirms the results of previous studies performed in other countries, showing that pulmonary symptoms decrease significantly with HME use and that related aspects such as speech and sleeping tend to improve, regardless of country or climate

Pretreatment organ function in patients with advanced head and neck cancer: clinical outcome measures and patients' views

<p>Abstract</p> <p>Background</p> <p>Aim of this study is to thoroughly assess pretreatment organ function in advanced head and neck cancer through various clinical outcome measures and patients' views.</p> <p>Methods</p> <p>A comprehensive, multidimensional assessment was used, that included quality of life, swallowing, mouth opening, and weight changes. Fifty-five patients with stage III-IV disease were entered in this study prior to organ preserving (chemoradiation) treatment.</p> <p>Results</p> <p>All patients showed pretreatment abnormalities or problems, identified by one or more of the outcome measures. Most frequent problems concerned swallowing, pain, and weight loss. Interestingly, clinical outcome measures and patients' perception did no always concur. E.g. videofluoroscopy identified aspiration and laryngeal penetration in 18% of the patients, whereas only 7 patients (13%) perceived this as problematic; only 2 out of 7 patients with objective trismus actually perceived trismus.</p> <p>Conclusion</p> <p>The assessment identified several problems already pre-treatment, in this patient population. A thorough assessment of both clinical measures and patients' views appears to be necessary to gain insight in all (perceived) pre-existing functional and quality of life problems.</p

Long-Term Results of Provox ActiValve, Solving the Problem of Frequent Candida- and "Underpressure"-Related Voice Prosthesis Replacements

Objectives: To assess the long-term results of the Provox ActiValve, a prosthesis for voice rehabilitation after total laryngectomy that was designed to lessen the need for frequent replacements caused by Candida and "underpressure." Patients and Methods: Retrospective assessment of device lifetime, indications for replacement, voice quality, and maintenance issues, measured by a structured trial specific questionnaire, in a cohort of 42 laryngectomized patients, experiencing a short Provox2 device lifetime (median, 21 days). Results: The median device lifetime of Provox ActiValve, replaced for leakage through the device and those still in situ at the date of data collection (N = 32), was 337 days (mean 376 days): a statistically significant 16-fold increase compared to the Provox2 prosthesis (P <.001). In 10 patients, replacement was fistula-related (median after 86 days): esophageal pouch (N = 4), fistula granulation (N = 3), extrusion of the device (N = 2), and periprosthetic leakage (N = 1). Eighty-six percent of the patients used a special lubricant to diminish "stickiness" of the valve. Provox ActiValve was preferred by 90% of the patients who completed the trial-specific questionnaire. Conclusions: For patients requiring frequent device-related replacements, Provox ActiValve, also long-term, provides a true solution and thereby is a valuable addition to prosthetic voice rehabilitatio

Quality-of-life assessment after supradose selective intra-arterial cisplatin and concomitant radiation (RADPLAT) for inoperable stage IV head and neck squamous cell carcinoma

OBJECTIVE: To evaluate quality-of-life (QOL) aspects of an organ preservation intra-arterial chemotherapy and concomitant radiation protocol, RADPLAT. DESIGN: Nonrandomized phase 2B feasibility trial. PATIENTS: Fifty consecutive patients with inoperable stage IV head and neck cancer. INTERVENTION: Supradose selective intra-arterial cisplatin and concomitant standard radiation (RADPLAT). MEASURES: Assessment with structured questionnaires before treatment and at 3, 6, and 12 months. RESULTS: Twenty-six patients were available for QOL assessment at 1 year (the "1-year QOL" group), as 16 patients died, 5 needed salvage surgery, and 3 were not available for interview (the "failure" group). Twelve-month results were mainly based on the first group. The functional well-being and head and neck scales showed a statistically significant improvement over time (P <.001). After 12 months, 21 patients (81%) returned to an oral diet, while 5 patients still needed tube feeding. For 23 patients (88%), the quality and strength of the voice was more or less normal. Of the 18 patients who were employed before their treatment, 10 were able to return to their job within 12 months. Xerostomia was reported by 17 patients (65%). Further detailed analysis showed statistically significant differences in pretreatment scores between the 1-year QOL group and the failure group, ie, physical well-being, functional well-being, and the head and neck scales (P <.05). Differences in these groups with respect to sex, age, tumor site, or stage could not be found. CONCLUSION: Given that only patients with locally (anatomic or functional) inoperable stage IV disease were treated, the results are promising, underlining the feasibility of the RADPLAT protoco

Prospective Clinical Phase II Study of Two New Indwelling Voice Prostheses (Provox Vega 22.5 and 20 Fr) and a Novel Anterograde Insertion Device (Provox Smart Inserter)

Objectives/Hypothesis: To assess device life of the new Provox Vega 22.5 and 20 Fr prostheses, to establish whether the optimized airflow characteristics of these devices materialize in better voice characteristics in comparison to Provox2, and to assess the feasibility of voice prosthesis replacement with the new Smart Inserter. Study Design: Prospective clinical phase II study. Methods: Prospective clinical phase II study including two patient cohorts (Provox Vega 22.5 Fr: N = 33; Provox Vega 20 Fr: N = 26). Device-life assessment, subjective data collection with study-specific structured questionnaires, perceptual analysis (Comparative Mean Opinion Score), and objective voice analysis (standard Dutch text, maximum phonation time, and dynamic range). Results: Device life of both prostheses appears comparable to Provox2. Several voice characteristics were better in Vega 22.5, which coincides well with patients' preference. Voicing with Vega 20 appears comparable to Provox2. Use of Smart Inserter showed a short learning curve, and was considered an improvement by the clinicians. Conclusions: The new Provox Vega 22.5 and 20 Fr prostheses have a device life comparable to Provox2, whereas voicing is better than (with the 22.5Fr version) or comparable (with the 20 Fr version) to Provox2. The Smart Inserter, after a short learning curve, turns out to be a further improvement of the anterograde replacement of these indwelling device

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 leakag

A new problem-solving indwelling voice prosthesis, eliminating the need for frequent Candida- and "underpressure"-related replacements: Provox ActiValve

OBJECTIVES: To develop and clinically assess a new prosthesis for voice rehabilitation after total laryngectomy that solves the problem of frequent Candida- and "underpressure"-related replacements. MATERIAL AND METHODS: We designed a voice prosthesis with a new valve mechanism, applying Candida-resistant fluoroplastic (Teflon-like) material for the valve and valve seat and magnets to generate an active closing force, preventing inadvertent opening of the valve during swallowing or deep inhalation. Several prototypes were tested in 13 laryngectomized patients and, subsequently, the final design was assessed in a prospective clinical trial in a cohort of 18 patients with a short device lifetime of their standard indwelling voice prosthesis (mean 30 days). RESULTS: Prototype testing and the long-term clinical trial confirmed that the new valve material remained free of Candida growth and that the use of magnets can prevent inadvertent opening of the valve during swallowing and/or deep inhalation. This resulted in a highly significant increase in device lifetime in the 18 laryngectomized patients in the prospective trial (14-fold increase on average, range 3-39-fold; p < 0.001). Lubrication with special medical-grade fluoridated silicone oil is favorable in patients who experience possible adhesion of the valve to the valve seat. CONCLUSIONS: This new voice prosthesis, the Provox ActiValve, represents a solution for patients who have the problem of requiring very frequent voice prosthesis replacements due to excessive Candida growth and/or inadvertent opening of the valve by swallowing and inhalation-related underpressure in the esophagu