Acquired tracheobronchomalacia developed following voice prosthesis implantation.

Acquired tracheobronchomalacia (ATBM) is a condition in which the tracheobronchial wall and cartilage progressively lose their rigidity, resulting in dynamic collapse during exhalation. In this report, we present a case of ATBM that developed following voice prosthesis implantation. To the best of our knowledge, this is the first documented case of such a condition in the medical English literature based on a PubMed search. A 63-year-old man was referred to National Kyushu Cancer Center in Japan with complaints of pharyngeal pain and a laryngeal tumor. The tumor was diagnosed as laryngeal cancer, and the patient underwent laryngectomy. Three months after the surgery, we implanted a voice prosthesis through a tracheoesophageal puncture. Two months after implantation, the patient experienced dyspnea. This condition was subsequently diagnosed as ATBM through computed tomography and bronchofiberscope examinations. After the removal of the voice prosthesis, there has been no progression of ATBM for over five years. While ATBM may not be a common occurrence in the practice of head and neck surgeons, it should be considered as a potential complication when patients report dyspnea following voice prosthesis implantation.

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.

[Indications and complications prevention and management of phaseâ ¡ implantation of Provox Vega voice prosthesis after total laryngectomy].

Objective: To explore the indications and management of common postoperative complications of phase II tracheoesophageal puncture (TEP) for Provox Vega voice prosthesis after total laryngectomy. Methods: The clinical data of 20 patients undergoing phase II TEP for Provox Vega voice prosthesis in our hospital between May 2021 and January 2022 were analyzed. Among them, there were 19 males and 1 female, aged from 37 to 76 years, with an average age of (60.0±8.4)years. The surgical indications and the prevention and treatment of common postoperative complications were summarized. Descriptive analysis was used in this research. Results: The basic surgical indications were as following: after total laryngectomy, there was no stenosis of the stoma and esophagus entrance, no scar constitution, no mouth opening restriction, no stiffness and backward restraint of the neck after radiotherapy, and more than half a year apart surgery or radiotherapy. Among the 20 patients, 18 underwent implantation successfuly, 1 failed in the operation, and for 1 patient, the prosthesis was removed due to bleeding 1 week after implantation. The common postoperative complications included TEP fistula infection (2 cases), the TEP fistula bleeding(1 case), deep neck (prevertebral) abscess (1 case), granulation at the inner side of the TEP fistula (1 case), invagination of the prosthesis (2 cases) and leakage around the prosthesis (2 cases). All patients were cured with different interventions. Conclusions: The Provox Vega voice prosthesis is generally safe for phase Ⅱ implantatione, but implantation indications need to be established. Common postoperative complications can be solved through preventive and remedial interventions.

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.

Does Prophylactic Replacement of Voice Prosthesis Make Sense? A Study to Predict Prosthesis Lifetime.

OBJECTIVE: Voice prosthesis leakage significantly affects the quality of life of patients undergoing laryngectomy, causing insecurity and frequent unplanned hospital visits and costs. In this study, the concept of prophylactic voice prosthesis replacement was explored to prevent leakages. STUDY DESIGN: Retrospective cohort study. SETTING: Tertiary hospital. METHODS: This study included all patients who underwent laryngectomy between 2000 and 2012 in the Netherlands Cancer Institute. Device lifetimes and voice prosthesis replacements of a retrospective cohort were used to calculate the number of needed voice prostheses per patient per year to prevent 70% of the leakages by prophylactic replacement. Various strategies for the timing of prophylactic replacement were considered: adaptive strategies based on the individual patient's history of replacement and fixed strategies based on the results of patients with similar voice prosthesis or treatment characteristics. RESULTS: Patients used a median 3.4 voice prostheses per year (range, 0.1-48.1). We found high inter- and intrapatient variability in device lifetime. When prophylactic replacement is applied, this would become a median 9.4 voice prostheses per year, which means replacement every 38 days, implying >6 additional voice prostheses per patient per year. The individual adaptive model showed that preventing 70% of the leakages was impossible for most patients and only a median 25% can be prevented. Monte-Carlo simulations showed that prophylactic replacement is not feasible due to the high coefficient of variation (SD/mean) in device lifetime. CONCLUSION: Based on our simulations, prophylactic replacement of voice prostheses is not feasible due to high inter- and intrapatient variation in device lifetime.

Indications and complications prevention and management of phaseⅡ implantation of Provox Vega voice prosthesis after total laryngectomy / 中华耳鼻咽喉头颈外科杂志

Objective: To explore the indications and management of common postoperative complications of phase II tracheoesophageal puncture (TEP) for Provox Vega voice prosthesis after total laryngectomy. Methods: The clinical data of 20 patients undergoing phase II TEP for Provox Vega voice prosthesis in our hospital between May 2021 and January 2022 were analyzed. Among them, there were 19 males and 1 female, aged from 37 to 76 years, with an average age of (60.0±8.4)years. The surgical indications and the prevention and treatment of common postoperative complications were summarized. Descriptive analysis was used in this research. Results: The basic surgical indications were as following: after total laryngectomy, there was no stenosis of the stoma and esophagus entrance, no scar constitution, no mouth opening restriction, no stiffness and backward restraint of the neck after radiotherapy, and more than half a year apart surgery or radiotherapy. Among the 20 patients, 18 underwent implantation successfuly, 1 failed in the operation, and for 1 patient, the prosthesis was removed due to bleeding 1 week after implantation. The common postoperative complications included TEP fistula infection (2 cases), the TEP fistula bleeding(1 case), deep neck (prevertebral) abscess (1 case), granulation at the inner side of the TEP fistula (1 case), invagination of the prosthesis (2 cases) and leakage around the prosthesis (2 cases). All patients were cured with different interventions. Conclusions: The Provox Vega voice prosthesis is generally safe for phase Ⅱ implantatione, but implantation indications need to be established. Common postoperative complications can be solved through preventive and remedial interventions.

Voice rehabilitation with voice prosthesis: Long term results, complications and risk factors.

OBJECTIVES: Despite the advances in surgical and non-surgical organ preservation treatments, total laryngectomy (TL) remains the most effective treatment in advanced larynx cancer and as salvage procedure in chemoradiation failure. One of the most devastating sequel after TL is loss of voice. Voice prosthesis (VP) is currently the preferred choice for voice rehabilitation. The purpose of this study is to identify VP complications, its lifespan and factors that influence the longevity of the VP. METHODS: We performed a retrospective study at a Tertiary University Hospital. Medical records of patients that underwent total laryngectomy, between January 1st of 2008 and 31st of December of 2017 were analyzed. RESULTS: Of the 84 patients that underwent laryngectomy, 60 had VP. The average age at the time of surgery 60.2 years old and there was a male preponderance (57:3). The mean lifespan of the prosthesis was 7.53 months. Leakage through the prosthesis was the most common reason for replacement of the prosthesis, followed by leakage around the prosthesis. Follow up time and manual suture were associated with prosthesis replacement. There was no significant relationship between the staging, tumor location or adjuvant radiotherapy and number of prosthesis replacement or its lifespan. CONCLUSIONS: Rehabilitation after TL is of major importance to improve quality of life after surgery. Tracheoesophageal puncture with voice prosthesis is a safe procedure for vocal rehabilitation and was performed in the majority of patients in our study. Follow-up time and type of suture were the main determinants of the lifespan of the prosthesis.

Oncological and psychological evaluation of laryngectomized patients, pre and post implantation of voice prostheses. A single center experience.

BACKGROUND: In our study we evaluated from an oncological and psychological point of view, a group of patients who had previously undergone total laryngectomy and candidates for the placement of a vocal prosthesis, which allows to recover the voice using the air that passes from the trachea to the esophagus, thus vibrating a segment of the cervical esophagus. For the placement of the prosthesis and the oncological follow-up, we used the support of videoendoscopy, to exclude any recurrence or secondary tumors. At the same time, we subjected patients to a psychological evaluation before and after the implantation of the prostheses, to understand the behavioral changes in the two phases, and the possible achievement of the result of total autonomy, social reintegration, and recovery of oral communication, in the post-surgical phase. METHODS: We performed a complete esophagogastroduodenoscopy and psychological evaluation on 42 patients who had previously undergone a total laryngectomy, before proceeding to the creation of a tracheoesophageal fistula and the placement of a phonatory prosthesis. After six months, we re-evaluated the same patients, both from an oncological and psychological point of view. RESULTS: At the preimplantation control of the prosthesis, in endoscopy we detected three neoplastic relapses that did not allow the placement of a prosthesis, and four patients who had grade B esophagitis according to the Los Angeles classification, in the remaining 35 patients there were no complications. At the psychological evaluation, most of the patients had psychosocial disorders, with phenomena of anxiety and depression. At the check-up six months after implantation, none of the patients had relapses, and the voice prosthesis was not fully functional in a single patient. From a psychological point of view, voice recovery has significantly improved relationships both in the family and in the social sphere. CONCLUSIONS: Our experience has confirmed the interesting and advantageous use of videoendoscopy in patients undergoing total laryngectomy and candidates for the placement of a tracheoesophageal vocal prosthesis, in the evaluation of neoplastic relapses and secondary lesions of the esophagus. The role of the psychologist both in the pre and post prosthetic phase is fundamental in assessing the discomfort of these patients by helping them solve some problems such as isolation and anxiety. KEY WORDS: Anxiety, Depression, Total laryngectomy, Voice prosthesis.

Voice Onset Time in Patients Using Speech Prosthesis After Total Laryngectomy.

AIM: Our study was carried out to investigate the presence of known differences in voice and articulation quality after total laryngectomy. Patients provided phonation with tracheoesophageal speech prosthesis. We recorded patients' voice onset time (VOT) values - an important parameter of acoustic analysis. METHODS: The study included 18 patients with total laryngectomy who received valvular speech prosthesis via a primary or secondary tracheoesophageal fistula between 2009 and 2011 at the Istanbul Training and Research Hospital Otorhinolaryngology Clinic. Twenty healthy male volunteers were included as the control group. All subjects produced the /pa/, /ta/, /ka/ syllables three times, and the VOT values were determined by recording the voices on a computer. RESULTS: A total of 38 male patients, 18 of which were patients with total laryngectomy and tracheoesophageal speech prosthesis (aged between 46 and 75 years, mean: 59) and 20 controls (aged between 50 and 70 years, mean: 58), were included in the study. The age distribution of the groups did not differ statistically (P > 0.05). In the total laryngectomy and tracheoesophageal speech prosthesis group, the VOT mean values of the /ka/ syllable were significantly lower than the control group, whereas the /pa/ (P = 0.848) and /ta/ VOT mean values (P = 0.809) were similar between groups. CONCLUSIONS: This study shows that there is no significant difference in the articulation of voiceless plosives, except for the /ka/ sound, between patients using speech prostheses after total laryngectomy and controls. For standardization of these measured values and their use in clinical practice, it may be beneficial to support this study with studies that involve more patients and examine different indicators showing the quality and intelligibility of other voice characteristics.

Tracheoesophageal fistula and pharyngoesophageal stenosis repair by double skin paddle radial forearm flap.

Tracheoesophageal fistula (TEF) constitutes a rare, but serious complication in laryngectomized patients, usually occurring after radiotherapy. TEF may occur spontaneously or may be due to enlargement of the TEF created for placement of a voice prosthesis. Surgical treatment of TEF can be complex, especially in the presence of a concomitant pharyngoesophageal stenosis (PES), and is associated with a high failure rate. In this article, we describe the surgical reconstruction technique for TEF associated with PES using a double skin paddle fasciocutaneous radial forearm free flap. The key points of this technique consist of correct positioning of the 2 skin paddles in order to reconstruct the anterior pharyngoesophageal wall and posterior tracheal wall, as well as de-epidermization of the intermediate part of the flap, which is then placed in the tracheoesophageal space.

Complications following secondary voice prosthesis insertion and impact of previous irradiation on their appearance.

OBJECTIVE: The aim of this study was to analyze the complications following secondary voice prosthesis insertion and impact of previous irradiation on their appearance. METHODS: This study included 106 totally laryngectomized patients who underwent secondary Provox 2 voice prosthesis insertion. Among them, 79 (74.5%) were irradiated. Surgery, prosthesis, fistula, and voice-related complications were analyzed and presented. RESULTS: Complications occurred in 23 (22%) patients. Fifteen of them were previously irradiated. There were no surgery-related complications. In the group of prosthesis-related complications, one patient had increased negative pressure during swallowing with extremely short prosthesis life time. There were 17 complications in the group of fistula related ones; 3 patients had excessive granulation tissue around the fistula and 14 patients experienced prosthesis displacement (7 had closed esophageal end of the fistula, 5 had the prosthesis turned sideways in an open fistula, one patient inhaled and one ingested the prosthesis). Tracheoesophageal voice was not established in 5 patients. Previous irradiation had no statistically significant influence on the complication rate (P = 0,251). CONCLUSIONS: The majority of complications following secondary voice prosthesis insertion are fistula-related ones, among which, displacement of the voice prosthesis is the most common. Previous irradiation does not significantly increase the risk of developing complications.

Autologous platelet-rich fibrin: a novel method for tracheoesophageal puncture site closure: a case report.

Closure of a tracheoesophageal puncture site performed during voice prosthesis implantation may sometimes be required. Besides local techniques, more elaborate procedures, such as closure by means of free microvascular flaps, have been advocated. In this report, we describe a case of local treatment of a hard-to-heal fistula with local application of autologous platelet-rich fibrin matrix in a 77-year-old male patient. At one-week follow-up, the size of the fistula had decreased dramatically but some leakage remained when drinking. After one month, the patient was able to drink and eat normally without any leakage. There was no recurrence of the leakage at two years' follow-up. In summary, local application of platelet-rich fibrin seems to be a simple, safe and effective procedure for tracheoesophageal fistula closure.

Periprosthetic Leakage in Tracheoesophageal Prosthesis: Proposal of a Standardized Therapeutic Algorithm.

OBJECTIVE: Periprosthetic leakage represents the most demanding long-term complication in the voice prosthesis rehabilitation. The aim of this article is to discuss the various causes of periprosthetic leakage and to propose a systematic management algorithm. STUDY DESIGN: Retrospective cohort study. SETTING: Otolaryngology clinic of the University Polyclinic A. Gemelli-IRCCS Foundation. METHODS: The study included 115 patients with voice prosthesis who were treated from December 2014 to December 2019. All patients who experienced periprosthetic leakage were treated with the same step-by-step therapeutic approach until it was successful. Incidence, management, and success rate of every attempt are analyzed and discussed. RESULTS: Periprosthetic leakage was reported 330 times by 82 patients in 1374 clinic accesses. Radiotherapy, timing of tracheoesophageal puncture, and type of total laryngectomy (primary or salvage) did not influence the incidence of periprosthetic leakage. Salvage total laryngectomy increases the risk of more clinically relevant leakages. CONCLUSION: By using a systematic algorithm with a step-by-step standardized approach, periprosthetic leakage management could become a less treacherous issue.

Misplaced tracheoesophageal voice prosthesis: A case of foreign body aspiration.

Foreign body aspiration (FBA) is a rare, but potentially fatal condition frequently seen in the emergency department. Bronchoscopy plays a major role in its diagnosis and treatment. In patients with laryngectomy, the strategies for airway maintenance and foreign body retrieval are limited. We describe management of a patient with laryngectomy presenting with aspiration of a tracheoesophageal voice prosthesis (TEP). The TEP was not initially seen in chest radiography; however, computed tomography showed it within the right lower bronchus. Successful extraction of the TEP was achieved through bronchoscopy with forceps and retrieval basket. Otolaryngology placed a larger TEP and secured it with sutures. TEP migration is rare, but represents a risk for FBA. Initial imaging in the emergency department can be misleading, requiring a high degree of suspicion, as the TEP device may not be seen in standard chest radiography. Flexible bronchoscopy under moderate sedation in conjunction with forceps and retrieval basket may be appropriate for treatment of FBA in patients with laryngectomy and can be performed in the emergency department, preventing hospital admission.

Perceptual Voice and Speech Analysis after Supraglottic Laryngeal Closure for Chronic Aspiration in Head and Neck Cancer.

OBJECTIVES/HYPOTHESIS: To evaluate the voice and speech outcomes after tubed supraglottic laryngeal closure (TSLC) surgery to treat chronic aspiration after radiotherapy for head and neck cancer. STUDY DESIGN: A retrospective case-control study. METHODS: The data of patients who underwent radiotherapy for head and neck cancer and who later required total laryngectomy or TSLC for chronic aspiration between 2004 and 2017 were retrieved from a dysphagia clinic. Preoperative and postoperative voice and speech were assessed by the GRBAS and INFVo rating scales. Control subjects who underwent radiotherapy alone or total laryngectomy with a tracheoesophageal prosthesis for other indications were recruited for comparison. RESULTS: Of 15 patients who underwent a TSLC with a mean age of 57.3 years (45-75 years), 13 were male and 2 female. All patients had a history of nasopharyngeal carcinoma. The success rate of speech production using their own larynx following an intact TSLC was 64%. There was no statistically significant difference in voice and speech ratings between preoperative and TSLC subjects on the GRBAS (P = .32) and INFVo scales (P = .57), although the quality of voice appeared to deteriorate after TSLC. However, the INFVo scale for impression, intelligibility and unsteadiness of the voice after TSLC was statistically significantly better than for laryngectomy with tracheoesophageal speech. CONCLUSIONS: A tubed supraglottic laryngeal closure controls chronic aspiration while preserving the larynx for phonation, and results in a better voice and speech quality than a laryngectomy with a voice prosthesis. LEVEL OF EVIDENCE: 4 Laryngoscope, 131:E1616-E1623, 2021.

Patients With Voice Prosthesis Rehabilitation During the COVID-19 Pandemic: Analyzing the Effectiveness of Remote Triage and Management.

OBJECTIVE: To describe a remote approach used with patients with voice prosthesis after laryngectomy during the COVID-19 pandemic and the resulting clinical outcomes in terms of voice prosthesis complications management, oncological monitoring, and psychophysical well-being. STUDY DESIGN: Prospective cohort study. SETTING: Otolaryngology Clinic of the University Polyclinic A. Gemelli, IRCCS Foundation. SUBJECTS AND METHODS: All patients with voice prosthesis who underwent laryngectomy followed by our institute were offered enrollment. Patients who agreed to participate were interviewed to inquire about the nature of the need and to plan a video call with the appropriate clinician. Before and 1 week after the clinician's call, patients were tested with the Hospital Anxiety and Depression Scale. Degrees of satisfaction were investigated with a visual analog scale. A comparison between those who accepted and refused telematic support was carried out to identify factors that influence patient interest in teleservice. RESULTS: Video call service allowed us to reach 37 (50.68%) of 73 patients. In 23 (62.16%) of 37 cases, the video call was sufficient to manage the problem. In the remaining 14 cases (37.83%), an outpatient visit was necessary. Participants who refused telematic support had a significantly shorter time interval from the last ear, nose, and throat visit than patients who accepted (57.95 vs 96.14 days, P = .03). Video-called patients showed significantly decreased levels of anxiety and depression (mean Hospital Anxiety and Depression Scale total score pre- vs post-video call: 13.97 vs. 10.23, P < .0001) and reported high levels of satisfaction about the service. CONCLUSION: Remote approach may be a viable support in the management of patients with voice prosthesis rehabilitation.

Complications associated with tracheoesophageal voice prostheses from 2010 to 2020: A MAUDE study.

PURPOSE: Tracheoesophageal puncture with voice prosthesis placement remains the gold standard for voice restoration following total laryngectomy, but may cause various complications. This study aims to summarize patient-related and device-related adverse events associated with tracheoesophageal puncture and voice prosthesis placement. MATERIALS AND METHODS: The U.S. Food and Drug Administration's Manufacturer and User Facility Device Experience database was queried for reports of adverse events related to tracheoesophageal puncture with voice prosthesis placement from January 1, 2010, to April 30, 2020. Data were extracted from reports pertaining to tracheoesophageal prostheses. RESULTS: Seventy-seven reports involving tracheoesophageal voice prostheses were identified, from which 111 adverse events were extracted. Of these, 58 (52.3%) were patient-related, while 53 (47.7%) were device-related. The most frequently reported patient-related adverse events were aspirated prosthesis (24 [41.4%]), foreign body during placement (11 [19.0%]), aspiration pneumonia (9 [15.5%]), and aspirated brush tip (8 [13.8%]). The most common device-related adverse events were detached brush tip (15 [28.3%]), leak (14 [26.4%]), and torn esophageal flange (11 [20.8%]). CONCLUSIONS: While tracheoesophageal puncture with voice prosthesis placement has revolutionized voice rehabilitation following total laryngectomy, the procedure may be associated with adverse events both at the time of placement and later. Interventions aimed at improving both physician and patient education may help reduce adverse events attributed to improper use. Further research is needed to clarify optimal approaches to education.

Secondary Tracheoesophageal Puncture After Laryngectomy Increases Complications With Shunt and Voice Prosthesis.

OBJECTIVES/HYPOTHESIS: To evaluate the demographics, clinical features, management, and prognostic indicators of tracheoesophageal puncture complications in patients undergoing placement of voice prosthesis following cancer treatment. STUDY DESIGN: Retrospective analysis. METHODS: A retrospective analysis was conducted of cases from a tertiary referral center diagnosed between 1996 and 2015. Multivariate logistic regression was used to determine factors associated with tracheoesophageal puncture (TEP) and voice prostheses-complication-free survival (TEP/VP-CFS). RESULTS: One hundred fourteen cases were identified. Most patients were males (92.9%) with pT3 (26.8%) or pT4 (58.1%) N+ (53.6%) tumors. All patients received laryngectomy as the primary treatment, with 75% of patients receiving adjuvant radiation therapy or chemoradiotherapy. Complications with TEP were common (65.2%). The most frequent problem was salivary leakage (50.0%), which at the same time was the most common reason for changing the prosthesis. On univariate regression analysis, prosthesis placement time after adjuvant radiotherapy (hazard ratio [HR]: 4.17, 95% confidence interval [CI]: 2-8.69), secondary prosthesis placement after primary surgery (HR: 3.97, 95% CI: 1.99-7.9), and laryngectomy with flap reconstruction (HR: 1.96, 95% CI: 0.99-3.89) were significant prognosticators for complications. Multivariate regression analysis revealed secondary prosthesis placement after adjuvant radiotherapy (HR: 3.66, 95% CI: 1.39-9.68) or after primary surgery (HR: 2.57, 95% CI: 0.92-7.2) to be the strongest predictors of reduced TEP/VP-CFS. CONCLUSIONS: Secondary prosthesis placement after primary surgery, placement after previous irradiation, and laryngectomy with flap reconstruction are predictors of poor TEP/VP-CFS. Planned adjuvant radiotherapy is not a contraindication for TEP with prosthetic placement, but it is very important to place the prosthesis during the primary surgery or at least before scheduled radiotherapy. LEVEL OF EVIDENCE: 4 Laryngoscope, 2020.