Postlaryngectomy prosthetic voice rehabilitation outcomes in a consecutive cohort of 232 patients over a 13-year period.

BACKGROUND: With the increasing necessity for total laryngectomy (TL) after prior (chemo)radiotherapy, prosthetic vocal rehabilitation outcomes might have changed. METHODS: Retrospective cohort study including all patients laryngectomized between 2000 and 2012 with a voice prosthesis (VP) in the Netherlands Cancer Institute. RESULTS: Median device lifetimes of the standard Provox2 and Vega VPs are 63 and 66 days, respectively, and for the problem-solving ActiValve Light and Strong VPs 143 and 186 days, respectively. In multivariable analysis, salvage TL and TL for a dysfunctional larynx (compared to primary TL) were associated with a shorter device lifetime. Almost half of the patients (48%) experienced tracheoesophageal puncture tract-related problems, and this concerned 12% of all VP replacements. CONCLUSIONS: Compared to historical cohorts, device lifetimes of regular Provox2 and Vega voice prostheses have decreased. Complications are not occurring more frequently but affect more patients. Nevertheless, the clinical reliability and validity of prosthetic voice rehabilitation is still sound.

Comparative Study Between Peristomal Patches in Patients with Definitive Tracheostomy

Abstract Introduction To prevent or diminish pulmonary problems in laryngectomized patients, continuous use of a heat and moisture exchanger (HME) is recommended. Therefore, automatic speaking valves are also often combined with an HME to enable hands-free speech. In order to keep these devices in place, most commonly, peristomal patches are used. Objective This prospective clinical 2 x 2 crossover study aims at assessing the added value of a new patch for HME application, the Provox StabiliBase OptiDerm (SBO). The device combines the stable and conical base of the Provox StabiliBase with the skinfriendlier hydrocolloid Provox OptiDerm (OD) patch. Methods Thirty-two laryngectomized patients were included in this multicenter study. Participants were asked to compare SBO to OD, and to the patch they normally use. The primary outcome measure was patient preference. Results Overall, 60% of the participants had preference for their normally used patch, 23% preferred the SBO and 17% indicated no preference. When comparing the SBO to the OD, 43% preferred the SBO, 40% the OD and 17% had no preference. Conclusion Most patients preferred their normally used patch and SBO was favored by a subgroup. Provox StabiliBase OptiDerm seems to be a valuable addition to the existing patches and further increases patients' options for HME application.

Comparative Study Between Peristomal Patches in Patients with Definitive Tracheostomy.

Introduction To prevent or diminish pulmonary problems in laryngectomized patients, continuous use of a heat and moisture exchanger (HME) is recommended. Therefore, automatic speaking valves are also often combined with an HME to enable hands-free speech. In order to keep these devices in place, most commonly, peristomal patches are used. Objective This prospective clinical 2 × 2 crossover study aims at assessing the added value of a new patch for HME application, the Provox StabiliBase OptiDerm (SBO). The device combines the stable and conical base of the Provox StabiliBase with the skin-friendlier hydrocolloid Provox OptiDerm (OD) patch. Methods Thirty-two laryngectomized patients were included in this multicenter study. Participants were asked to compare SBO to OD, and to the patch they normally use. The primary outcome measure was patient preference. Results Overall, 60% of the participants had preference for their normally used patch, 23% preferred the SBO and 17% indicated no preference. When comparing the SBO to the OD, 43% preferred the SBO, 40% the OD and 17% had no preference. Conclusion Most patients preferred their normally used patch and SBO was favored by a subgroup. Provox StabiliBase OptiDerm seems to be a valuable addition to the existing patches and further increases patients' options for HME application.

Predictive factors for pharyngocutaneous fistulization after total laryngectomy: a Dutch Head and Neck Society audit.

BACKGROUND: Incidences of pharyngocutaneous fistulization (PCF) after total laryngectomy (TL) reported in the literature vary widely, ranging from 2.6 to 65.5%. Comparison between different centers might identify risk factors, but also might enable improvements in quality of care. To enable this on a national level, an audit in the 8 principle Dutch Head and Neck Centers (DHNC) was initiated. METHODS: A retrospective chart review of all 324 patients undergoing laryngectomy in a 2-year (2012 and 2013) period was performed. Overall PCF%, PCF% per center and factors predictive for PCF were identified. Furthermore, a prognostic model predicting the PCF% per center was developed. To provide additional data, a survey among the head and neck surgeons of the participating centers was carried out. RESULTS: Overall PCF% was 25.9. The multivariable prediction model revealed that previous treatment with (chemo)radiotherapy in combination with a long interval between primary treatment and TL, previous tracheotomy, near total pharyngectomy, neck dissection, and BMI < 18 were the best predictors for PCF. Early oral intake did not influence PCF rate. PCF% varied quite widely between centers, but for a large extend this could be explained with the prediction model. PCF performance rate (difference between the PCF% and the predicted PCF%) per DHNC, though, shows that not all differences are explained by factors established in the prediction model. However, these factors explain enough of the differences that, compensating for these factors, hospital is no longer independently predictive for PCF. CONCLUSIONS: This nationwide audit has provided valid comparative PCF data confirming the known risk factors from the literature which are important for counseling on PCF risks. Data show that variations in PCF% in the DHNCs (in part) are explainable by the variations in these predictive factors. Since elective neck dissection is a major risk factor for PCF, it only should be performed on well funded indication.

Ex vivo humidifying capacity and patient acceptability of stoma cloths in laryngectomized individuals.

BACKGROUND: Heat and moisture exchangers (HMEs) improve respiratory function after laryngectomy, but there is virtually no information on the benefit of traditional stoma cloths or other covers. METHODS: Two sequential studies were performed: (1) an ex vivo test was used to compare the humidifying capacity of stoma cloths to other coverings; and (2) a 4-week randomized trial was then performed to assess patient acceptability of cloths both alone and with an HME (N = 18). RESULTS: The humidifying capacity of the coverings tested varied widely. For stoma cloths, a humidifying capacity of 13.7 mg/L was found to decrease to 8.5 mg/L if air-leaks around the cloth occurred. Patients who used HMEs disliked stoma cloths because they interfered with voicing, they became soiled more easily, and were less effective at reducing coughing and mucus production. CONCLUSION: Although less acceptable to patients who use an HME, stoma cloths do provide significant humidifying capacity and should be encouraged when HMEs are unavailable or inappropriate. © 2017 Wiley Periodicals, Inc. Head Neck 39: 921-931, 2017.

Low level laser therapy/photobiomodulation in the management of side effects of chemoradiation therapy in head and neck cancer: part 1: mechanisms of action, dosimetric, and safety considerations.

PURPOSE: There is a large body of evidence supporting the efficacy of low level laser therapy (LLLT), more recently termed photobiomodulation (PBM), for the management of oral mucositis (OM) in patients undergoing radiotherapy for head and neck cancer (HNC). Recent advances in PBM technology, together with a better understanding of mechanisms involved, may expand the applications for PBM in the management of other complications associated with HNC treatment. This article (part 1) describes PBM mechanisms of action, dosimetry, and safety aspects and, in doing so, provides a basis for a companion paper (part 2) which describes the potential breadth of potential applications of PBM in the management of side-effects of (chemo)radiation therapy in patients being treated for HNC and proposes PBM parameters. METHODS: This study is a narrative non-systematic review. RESULTS: We review PBM mechanisms of action and dosimetric considerations. Virtually, all conditions modulated by PBM (e.g., ulceration, inflammation, lymphedema, pain, fibrosis, neurological and muscular injury) are thought to be involved in the pathogenesis of (chemo)radiation therapy-induced complications in patients treated for HNC. The impact of PBM on tumor behavior and tumor response to treatment has been insufficiently studied. In vitro studies assessing the effect of PBM on tumor cells report conflicting results, perhaps attributable to inconsistencies of PBM power and dose. Nonetheless, the biological bases for the broad clinical activities ascribed to PBM have also been noted to be similar to those activities and pathways associated with negative tumor behaviors and impeded response to treatment. While there are no anecdotal descriptions of poor tumor outcomes in patients treated with PBM, confirming its neutrality with respect to cancer responsiveness is a critical priority. CONCLUSION: Based on its therapeutic effects, PBM may have utility in a broad range of oral, oropharyngeal, facial, and neck complications of HNC treatment. Although evidence suggests that PBM using LLLT is safe in HNC patients, more research is imperative and vigilance remains warranted to detect any potential adverse effects of PBM on cancer treatment outcomes and survival.

Low-level laser therapy/photobiomodulation in the management of side effects of chemoradiation therapy in head and neck cancer: part 2: proposed applications and treatment protocols.

PURPOSE: There is a large body of evidence supporting the efficacy of low-level laser therapy (LLLT), more recently termed photobiomodulation (PBM) for the management of oral mucositis (OM) in patients undergoing radiotherapy for head and neck cancer (HNC). Recent advances in PBM technology, together with a better understanding of mechanisms involved and dosimetric parameters may lead to the management of a broader range of complications associated with HNC treatment. This could enhance patient adherence to cancer therapy, and improve quality of life and treatment outcomes. The mechanisms of action, dosimetric, and safety considerations for PBM have been reviewed in part 1. Part 2 discusses the head and neck treatment side effects for which PBM may prove to be effective. In addition, PBM parameters for each of these complications are suggested and future research directions are discussed. METHODS: Narrative review and presentation of PBM parameters are based on current evidence and expert opinion. RESULTS: PBM may have potential applications in the management of a broad range of side effects of (chemo)radiation therapy (CRT) in patients being treated for HNC. For OM management, optimal PBM parameters identified were as follows: wavelength, typically between 633 and 685 nm or 780-830 nm; energy density, laser or light-emitting diode (LED) output between 10 and 150 mW; dose, 2-3 J (J/cm(2)), and no more than 6 J/cm(2) on the tissue surface treated; treatment schedule, two to three times a week up to daily; emission type, pulsed (<100 Hz); and route of delivery, intraorally and/or transcutaneously. To facilitate further studies, we propose potentially effective PBM parameters for prophylactic and therapeutic use in supportive care for dermatitis, dysphagia, dry mouth, dysgeusia, trismus, necrosis, lymphedema, and voice/speech alterations. CONCLUSION: PBM may have a role in supportive care for a broad range of complications associated with the treatment of HNC with CRT. The suggested PBM irradiation and dosimetric parameters, which are potentially effective for these complications, are intended to provide guidance for well-designed future studies. It is imperative that such studies include elucidating the effects of PBM on oncology treatment outcomes.

Predictive factors for pharyngocutaneous fistulization after total laryngectomy.

OBJECTIVES: Postoperative complications, especially pharyngocutaneous fistulization (PCF), are more frequent after total laryngectomy (TL) performed for salvage after (chemo)radiotherapy than after primary TL. The aim of this study was to identify the incidence of PCF, predictive factors for PCF, and the relationship of PCF to survival. METHODS: We performed a retrospective chart review of 217 consecutive patients treated with TL between 2000 and 2010. Univariate and multivariable analysis with logistic regression was used to identify factors associated with PCF. We used a Kaplan-Meier survival analysis. RESULTS: The overall incidence of PCF was 26.3% (57 of 217 cases). The incidence of PCF after primary TL was 17.1% (12 of 70), that after salvage TL was 25.5% (25 of 98), that after TLE for a second primary was 37.5% (9 of 24), and that after TL for a dysfunctional larynx was 44.0% (11 of 25). The predictive factors for PCF were hypopharynx cancer (odds ratio [OR], 3.67; 95% confidence interval [CI], 1.74 to 7.71; P = .001), an albumin level of less than 40 g/L (OR, 2.20; 95% CI, 1.12 to 4.33; P = .022), previous chemoradiotherapy (OR, 3.38; 95% CI, 1.34 to 8.52; P = .010), more-extended pharyngeal resection (P = .001), and pharynx reconstruction (P = .002). The median duration of survival was 30 months (95% CI, 17.5 to 42.5); the 2-year overall survival rate was 54%. The median duration of survival of patients with PCF was 23 months (95% CI, 9.4 to 36.6), and that of those without PCF was 31 months (95% CI, 15.0 to 47.0; P = .421). The 2-year overall survival rate was 48% in patients with PCF and 57% in those without PCF (P = .290). CONCLUSIONS: Incidence of PCF after TL is significantly higher in patients with hypopharynx cancer, previous chemoradiotherapy, a low albumin level, more-extended pharyngeal resection, or pharynx reconstruction. The occurrence of PCF does not influence the rate of survival.

Early oral intake after total laryngectomy does not increase pharyngocutaneous fistulization.

Timing of oral intake after total laryngectomy (TLE) is mostly delayed until postoperative day 10-12, under the assumption that this limits the incidence of pharyngocutaneous fistulization (PCF). However, early oral intake could be advantageous and could reduce costs, providing that it does not lead to increased PCF. Comparison of PCF incidence in traditional 'late' oral intake protocol (start at postoperative day 10-12; LOI) and in early oral intake protocol (start at postoperative day 2-4; EOI). Retrospective cohort study comparing two different oral intake protocols in 247 consecutive patients laryngectomized between early 2000 until mid 2006 (LOI; N = 140), and mid 2006 until mid 2012 (EOI; N = 107). Both groups were comparable in terms of sex, age, origin of tumor, and TLE indication, except for the American Society of Anesthesiologists score (ASA), which was slightly more favorable in the LOI group (p = 0.047). Compliance with the oral intake protocols during both periods was good: the median day of starting oral intake was day 11 (range 6-103) in the LOI group vs. day 3 (range 2-84) in the EOI group (p = 0.001). The incidence of PCF was not significantly different between the two groups (25% for LOI and 32% for EOI; Fisher's exact: p = 0.255). In addition, no association was observed between the timing of oral intake and PCF (HR = 0.995; CI 0.98-1.01; p = 0.364). This study suggests that early oral intake is safe and does not increase pharyngocutaneous fistulization.