Evidence-Based Recommendations in Primary Tracheoesophageal Puncture for Voice Prosthesis Rehabilitation.

Head and neck cancer, the seventh most common cancer worldwide, often affects the larynx, with a higher incidence in men. Total laryngectomy, a common treatment, results in the loss of phonation, and tracheoesophageal voice rehabilitation is the current rehabilitation method of choice. Despite ongoing debates regarding the timing of tracheoesophageal puncture (TEP), a crucial procedure for voice prosthesis placement, the secondary puncture continues to be the preferred choice in the majority of cases. This underscores the persistent controversy and the absence of consensus in this field. The aim of this manuscript was to define evidence-based recommendations regarding the procedure of primary TEP with voice prosthesis placement, establish the conditions and requirements for performing primary TEP, determine the indications and contraindications of primary TEP, as well as to define the complications and management of primary TEP. A total of 19 statements were formulated, with 78.95% of them having a Level of Evidence 4 and a Grade of Recommendation C. There is not sufficient evidence comparing the outcomes of primary TEP versus secondary TEP. Future studies with robust methodologies are needed to clarify the role of primary and secondary TEP in the rehabilitation of patients undergoing total laryngectomy.

Velopharyngeal Incompetence in Musicians: A State-of-the-Art Review.

The velopalatine sphincter is a muscular valve that creates a hermetic seal between the nasopharynx and the oropharynx. It guarantees phonation, swallowing, and breathing (forces expirations). In wind musicians, sphincter closure must be precise during sound generation. Its failure will cause velopharyngeal incompetence (VPI) and the end of professional success. The objective of this article was to conduct a state-of-art review of VPI in wind musicians with a systematic approach based on the PRISMA Statement. The etiology, epidemiology, clinic, diagnosis, and treatment of VPI in wind musicians were evaluated. The research was carried out in different databases (PubMed/MEDLINE, the Cochrane Library, Scielo) and through the Mergullador metasearch engine. A total of 20 publications were selected. VPI is a pathology that affects around one-third of wind musicians according to studies. It causes pharyngeal noises and nasal air emissions during performance. The main etiology seems to be the fatigue of the velopalatine sphincter muscles. The most used diagnostic techniques consist of clinical history, physical examination, and nasofibroscopy. There is no consensus among authors about therapeutic management. Future investigations are necessary to confirm that fatigue of velopalatine sphincter muscles and other factors that increase it are the main causes of VPI in wind musicians.

Cost-Effectiveness Study of Double-Flange Voice Prostheses in the Treatment of Periprosthetic Leakage in Laryngectomized Patients.

BACKGROUND: Tracheoesophageal speech with a voice prosthesis is considered the rehabilitation treatment of choice in laryngectomized patients. The main reasons for prosthesis failure are endoprosthetic leakage and periprosthetic leakage. The Provox XtraSeal® stent incorporates an additional double flange on the esophageal side to prevent periprosthetic leakage. The objective of this study is to compare the duration and costs of the Provox Vega® and Provox XtraSeal® prostheses used in these patients in a tertiary university hospital. MATERIALS AND METHODS: A prospective crossover case study of laryngectomees with Provox Vega® who underwent Provox XtraSeal® placement due to recurrent periprosthetic leaks and decreased theoretical prosthesis life. The duration and possible factors affecting voice prostheses were studied using Kaplan-Meier curves and Cox regression. A cost-effectiveness analysis was carried out from the perspective of the Spanish National Health System with an incremental cost-effectiveness calculation. RESULTS: A total of 38 patients were recruited, 35 men and 3 women, with a mean age of 66.26 ± 9.36 years old. Information was collected from 551 voice prostheses, 484 Provox Vega® and 68 Provox XtraSeal®. The mean duration of Provox Vega® was 119.75 ± 148.8 days and that of Provox XtraSeal® was 181.99 ± 166.07 days (p = 0.002). The most frequent reason for replacement was endoprosthetic leakage in both groups: 283 (60.86%) in the case of Provox Vega® and 29 (48.33%) in that of XtraSeal® (p < 0.000). To obtain no cost differences (ICE ~ 0) between Provox Vega and Provox XtraSeal, the latter should cost EUR 551.63. CONCLUSIONS: The Provox XtraSeal® is a cost-effective option in patients with increased prosthesis replacements due to periprosthetic leakage, reducing the number of replacements, increasing the duration of the prosthesis, and providing savings compared to Provox Vega®.

Tissue augmentation treatment for periprosthetic leakage in patients who have undergone a total laryngectomy: A systematic review.

OBJECTIVES: Tracheoesophageal puncture (TEP) is considered the gold standard for voice rehabilitation after total laryngectomy. One of the main causes of treatment failure, and a potentially serious complication, is the TEP enlargement and/or leakage around the voice prosthesis. The injection of biocompatible material to increase the volume of the puncture surrounding tissue has been studied as a popular option for conservative treatment of enlarged tracheoesophageal fistula. The aim of this paper was to perform a systematic review of the efficacy and safety of such treatment. DESINGN: Search conducted in PubMed/MEDLINE, the Cochrane Library, Google Scholar, Scielo and Web of Science and through the meta-searcher Trip Database based on Preferred Reporting Items for a Systematic Review and Meta-analysis (PRISMA) statement. SETTINGS: Human experiments published in peer-reviewed journals, where investigators assessed the use of peri-fistular tissue augmentation for periprosthetic leakage were evaluated. PARTICIPANTS: Laryngectomized patients with voice prosthesis, presenting periprosthetik leak due to enlarged fistula. MAIN OUTCOMES MEASURES: mean-duration without new leak. RESULTS: A total of 196 peri-fistular tissue augmentation procedures in 97 patients were found in the 15 selected articles. The 58.8% of patients had a time without periprosthetic leak after treatment of >6 months. The 88.7% of tissue augmentation treatments resulted in periprosthetic leakage cessation. The general level of evidence of the studies included in this review was low. CONCLUSIONS: Tissue augmentation treatment is a minimally invasive, biocompatible and safe solution that temporarily resolves periprosthetic leaks in many cases. There is no standard technique or material, and treatment needs to be individualised according to the experience of the practitioner and the characteristics of the patient. Future randomised studies are needed to confirm these results.

Acoustic Characterization of the Voice With a Tracheoesophageal Speech in Laryngectomized Patients. Similarities and Differences With the Laryngeal Voice.

BACKGROUND: Voice with tracheoesophageal speech (TES) is an effective, widely recognized option to restore the ability of oral communication to laryngectomized patients. In this study, we try to characterize the TES, taking account different variables and making an acoustic analysis of voice with TES versus laryngeal voice (LV). METHODS: We compare different acoustic and subjective variables like GRABS or VHI in 34 patients with TES and 31 controls with LV. RESULTS: Patients with TES reach a good quality of voice with F0, F1, F2, F3, Jitter, Shimmer, and Yanahigara test similar to control group. Furthermore, the subjective scales show a good perception of voice for patients and examiners. CONCLUSIONS: Patients with tracheoesophageal voices show acceptable voice results, in many cases reaching to be near to controls with LV.

Prevention of periprosthetic leakage with double flange voice prosthesis: a systematic review and management protocol proposal.

OBJECTIVE: To conduct a systematic review of the use and results of the Provox®VegaTMXtraSealTM in the prevention of periprosthetic leakage and to propose a management protocol for this voice prosthesis. METHODS: Systematic search based on the PRISMA Statement during February 2020. Keywords were double flange, periprosthetic leakage, voice prosthesis, and laryngectomy. RESULTS: Four articles with 315 voice prosthesis (94 XtraSeal and 221 controls) in 55 patients were found. The XtraSeal mean duration was 114.28 ± 73.2 (CI 95%, 98.29-130.26) days compared to 102.98 ± 17.74 (CI 95%, 100.62-105.35) days of the control group. Out of 266 replacements, endoprosthetic leakage was the most frequent cause in both groups (62.41%). Periprosthetic leaks were less frequent in the XtraSeal (9.62%) than in the control group (22.43%). CONCLUSIONS: The XtraSeal could be effective in preventing periprosthetic leakage and lengthening the time between replacements. Studies with a robust methodology are necessary to confirm these results. Managing voice prosthesis is complex and requires a multidisciplinary and systematic approach by experienced professionals to reduce replacements and complications. Incorrect placement of the XtraSeal could cause a foreign body reaction and consequently inflammation, extrusion, or pressure lesions. The Tower of Hercules protocol: (1) Measurement of the tracheoesophageal fistula using the Provox® Measure, (2) Minimization of XtraSeal slack by avoiding the complete visualization of the prosthesis' blue ring, (3) Nasofibroscopic examination of the oesophageal wall confirming both flanges are in correct position; could prevent or minimize complications derived from the use of the XtraSeal.

Long-term outcomes and cost-effectiveness of a magnet-based valve voice prosthesis for endoprosthesis leakage treatment.

PURPOSE: Tracheoesophageal speech is considered the gold standard for rehabilitation following total laryngectomy. The main reason of voice prosthesis failure is the endoprosthesis leakage. Provox ActiValve® incorporates a magnet-based valve system to achieve active closure of the valve to treat these leakages, with the drawback of being significantly more expensive. The aim of the study was to compare the Provox Vega® and Provox ActiValve® duration and costs in patients with replacements increase due to endoprosthetic leakage. METHODS: Prospective case-crossover study in laryngectomized patients with Provox Vega® and endoprosthesis leakage to whom a Provox ActiValve® was placed. Survival and possible factors that affect voice prosthesis were studied using Kaplan-Meier curves and Cox Proportional Hazards Regression. Cost-effectiveness analysis from the perspective of the Spanish Public National Health System with incremental cost-effectiveness calculation was performed. RESULTS: A total of 159 prostheses were evaluated. The most frequent reason for replacement was the endoprosthesis leakage (N = 129; 83.77%) in both models. The mean duration-time of Provox Vega® was 44.77 ± 2.82 days (CI 95%, 39.18-50.35; median 36 days), and 317.34 ± 116.8 days (CI 95% 86.66-548; median 286 days) for the Provox ActiValve® (p < 0.000). For every replacement not made thanks to the Provox ActiValve® there was saving of 133.97€ CONCLUSIONS: The Provox ActiValve® is a cost-effective solution in patients with increased prosthesis replacements due to endoprosthetic leakage, reducing the number of changes and cost compared to Provox Vega®.

Use of double flange voice prosthesis for periprosthetic leakage in laryngectomised patients: A prospective case-crossover study.

INTRODUCTION: Tracheoesophageal speech is considered the gold standard for rehabilitation following total laryngectomy. One of the main problems of voice prosthesis is the periprosthesis leakage. Provox Vega XtraSeal incorporates a double flange on the pharyngeal side of the prosthesis in order to avoid these failures. The aim of the study is to compare the device lifetime between the Provox Vega and Provox Vega XtraSeal and to examine possible related factors that influence their duration. METHODS: Prospective case-crossover study in 20 laryngectomised patients with Provox Vega and periprothesis leakage to whom a Provox Vega XtraSeal was placed. Survival and possible factors that affect voice prosthesis were studied using Kaplan-Meier curves and Cox Proportional Hazards Regression with Schoenfeld residuals to test the possible assumptions. RESULTS: A total of 230 prostheses were evaluated. The most frequent reason for replacement was due to an endoprosthesis leakage (n = 146, 67%) in both models. Mean lifetime of Provox Vega was 104.474 ± 7.29 days (CI 95% 90.19-118.76) and of Provox XtraSeal was 176.76 ± 26.46 days (CI 95% 124.9-228.61) (P = .012). Complementary treatment with radiotherapy demonstrated a higher device survival (P = .007). DISCUSSION: Provox XtraSeal seems to be effective reducing the number of changes due to periprosthetic leakage, thus increasing the survival of voice prosthesis.

Provox 2® and Provox Vega® device life-time: a case-crossover study with multivariate analysis of possible influential factors and duration.

INTRODUCTION: Tracheoesophageal speech is considered the gold standard for rehabilitation following total laryngectomy. Current literature is limited and contradictory about the possible causes of device failure. The aim of the study is to compare the device life-time between the Provox 2 and Provox Vega and to examine possible related factors that influence their duration. METHODS: Retrospective case-crossover study in 34 laryngectomized patients who had undergone tracheoesophageal voice rehabilitation using indwelling Provox 2 and Provox Vega voice prostheses between 2010 and 2016 in a tertiary care centre. RESULTS: A total of 440 prostheses were evaluated. The most frequent reason for replacement was due to an endoprosthesis leakage (n = 221, 64.2%) in both models. Radiotherapy increases the risk of prosthesis replacement (IRR = 1.88, p = 0.007) as well as bilateral neck dissection (IRR = 1.56, p = 0.017) in Provox 2. Age and unilateral neck dissection do not seem to influence the duration of the prosthesis. Mean life-time of Provox 2 was 106.64 days and 124.19 days for Provox Vega (p = 0.261). Complementary treatment with radiotherapy demonstrated a lower device survival (p < 0.001). DISCUSSION: Results confirmed the non-significant differences on device life between Provox Vega and Provox 2, as well as the relevant role of radiotherapy treatment in the increase of replacements and diminution of the device duration.