Clinical Implementation of DIGEST as an Evidence-Based Practice Tool for Videofluoroscopy in Oncology: A Six-Year Single Institution Implementation Evaluation.

Clinical implementation of evidence-based practice (EBP) tools is a healthcare priority. The Dynamic Grade of Swallowing Toxicity (DIGEST) is an EBP tool developed in 2016 for videofluoroscopy in head and neck (H&N) oncology with clinical implementation as a goal. We sought to examine: (1) feasibility of clinical implementation of DIGEST in a national comprehensive cancer center, and (2) fidelity of DIGEST adoption in real-world practice. A retrospective implementation evaluation was conducted in accordance with the STARI framework. Electronic health record (EHR) databases were queried for all consecutive modified barium swallow (MBS) studies conducted at MD Anderson Cancer Center from 2016 to 2021. Implementation outcomes included: feasibility as measured by DIGEST reporting in EHR (as a marker of clinical use) and fidelity as measured by accuracy of DIGEST reporting relative to the decision-tree logic (penetration-aspiration scale [PAS], residue, and Safety [S] and Efficiency [E] grades). Contextual factors examined included year, setting, cancer type, MBS indication, and provider. 13,055 MBS were conducted by 29 providers in 7,842 unique patients across the lifespan in diverse oncology populations (69% M; age 1-96 years; 58% H&N cancer; 10% inpatient, 90% outpatient). DIGEST was reported in 12,137/13,088 exams over the 6-year implementation period representing 93% (95% CI: 93-94%) adoption in all exams and 99% (95% CI: 98-99%) of exams excluding the total laryngectomy population (n = 730). DIGEST reporting varied modestly by year, cancer type, and setting/provider (> 91% in all subgroups, p < 0.001). Accuracy of DIGEST reporting was high for overall DIGEST (incorrect SE profile 1.6%, 200/12,137), DIGEST-safety (incorrect PAS 0.4% 51/12,137) and DIGEST-efficiency (incorrect residue 1.2%, 148/12,137). Clinical implementation of DIGEST was feasible with high fidelity in a busy oncology practice across a large number of providers. Adoption of the tool across the lifespan in diverse cancer diagnoses may motivate validation beyond H&N oncology.

Performance and attitudes toward real-time computer-aided polyp detection during colonoscopy in a large tertiary referral center in the United States.

BACKGROUND AND AIMS: Computer-aided detection (CADe) has been shown to improve polyp detection in clinical trials. Limited data exist on the impact, utilization, and attitudes toward artificial intelligence (AI)-assisted colonoscopy in daily clinical practice. We aimed to evaluate the effectiveness of the first U.S. Food and Drug Administration-approved CADe device for polyp detection in the United States and the attitudes toward its implementation. METHODS: We performed a retrospective analysis of a prospectively maintained database of patients undergoing colonoscopy at a tertiary center in the United States before and after a real-time CADe system was made available. The decision to activate the CADe system was at the discretion of the endoscopist. An anonymous survey was circulated among endoscopy physicians and staff at the beginning and conclusion of the study period regarding their attitudes toward AI-assisted colonoscopy. RESULTS: CADe was activated in 52.1% of cases. Compared with historical control subjects, there was no statistically significant difference in adenomas detected per colonoscopy (1.08 vs 1.04, P = .65), even after excluding diagnostic and therapeutic indications and cases where CADe was not activated (1.27 vs 1.17, P = .45). In addition, there was no statistically significant difference in adenoma detection rate (ADR), median procedure, and withdrawal times. Survey results demonstrated mixed attitudes toward AI-assisted colonoscopy, of which main concerns were high number of false-positive signals (82.4%), high level of distraction (58.8%), and impression it prolonged procedure time (47.1%). CONCLUSIONS: CADe did not improve adenoma detection in daily practice among endoscopists with high baseline ADRs. Despite its availability, AI-assisted colonoscopy was only activated in half of the cases, and multiple concerns were raised by staff and endoscopists. Future studies will help elucidate the patients and endoscopists that would benefit most from AI-assisted colonoscopy.

Education, training, and knowledge of infection control among endoscopy technicians and nurses.

Our survey of 88 endoscopy technicians and nurses to determine their experience, training, and knowledge of infection control found that few personnel (<15%) received formal training in endoscope reprocessing or infection prevention before or after joining an endoscopy unit. While self-reported confidence in endoscope reprocessing was high (9 out of 10), knowledge of best practices in this regard lagged (average assessment score of 62%).

Eat All Through Radiation Therapy (EAT-RT): Structured therapy model to facilitate continued oral intake through head and neck radiotherapy-User acceptance and content validation.

BACKGROUND: To develop and examine user acceptance and content validity of a structured program to facilitate safe but challenging oral intake during radiotherapy (RT) delivered by a speech language pathologist (SLP)-the Eat-All Through Radiation Therapy (EAT-RT) program. METHODS: EAT-RT was developed through expert consensus of SLPs at the Princess Margaret Cancer Centre (Canada) and M D Anderson Cancer Center using a conceptual framework of a diet hierarchy and a mealtime routine. EAT-RT was refined by practicing SLPs, and then disseminated for a 4-week clinical pilot at seven sites who were subsequently invited to participate in an online survey. RESULTS: Twelve SLPs from six sites piloted EAT-RT therapy with a median of eight patients (IQR: 2-15) before and/or during RT. All SLPs reported EAT-RT added value to their practice, harmonized well with exercises, and its content was helpful; 11 (92%) reported EAT-RT facilitated patient understanding and indicated the desire to continue using EAT-RT. CONCLUSION: The EAT-RT program was accepted by North American SLPs. The findings support the content and value of EAT-RT to facilitate oral intake in patients with head and neck cancer throughout RT.

Expiratory muscle strength training for radiation-associated aspiration after head and neck cancer: A case series.

OBJECTIVE/HYPOTHESIS: Expiratory muscle strength training (EMST) is a simple, inexpensive, device-driven exercise therapy. Therapeutic potential of EMST was examined among head and neck cancer survivors with chronic radiation-associated aspiration. STUDY DESIGN: Retrospective case series. METHODS: Maximum expiratory pressures (MEPs) were examined among n = 64 radiation-associated aspirators (per penetration-aspiration scale score ≥ 6 on modified barium swallow). Pre-post EMST outcomes were examined in a nested subgroup of patients (n = 26) who enrolled in 8 weeks of EMST (25 repetitions, 5 days/week, 75% load). Nonparametric analyses examined effects of EMST on the primary endpoint MEPs. Secondary measures included swallowing safety (Dynamic Imaging Grade of Swallowing Toxicity [DIGEST]), perceived dysphagia (M.D. Anderson Dysphagia Inventory [MDADI]), and diet (performance status scale for head and neck cancer patients [PSSHN]). RESULTS: Compared to sex-matched published normative data, MEPs were reduced in 91% (58 of 64) of aspirators (mean ± standard deviation: 89 ± 37). Twenty-six patients enrolled in EMST and three patients withdrew. MEPs improved on average 57% (87 ± 29 to 137 ± 44 cm H2 O, P < 0.001) among 23 who completed EMST. Swallowing safety (per DIGEST) improved significantly (P = 0.03). Composite MDADI scores improved post-EMST (pre-EMST: 59.9 ± 17.1, post-EMST: 62.7 ± 13.9, P = 0.13). PSSHN diet scores did not significantly change. CONCLUSION: MEPs were reduced in chronic radiation-associated aspirators relative to normative data, suggesting that expiratory strengthening could be a novel therapeutic target to improve airway protection in this population. Similar to findings in neurogenic populations, these data also suggest improved expiratory pressure-generating capabilities after EMST and translation to functional improvements in swallowing safety in chronic radiation-associated aspirators. LEVEL OF EVIDENCE: 4. Laryngoscope, 128:1044-1051, 2018.

Cough strength and expiratory force in aspirating and nonaspirating postradiation head and neck cancer survivors.

OBJECTIVE: Expiratory functions that clear aspiration from the airway are compromised in patients with neurogenic dysphagia for whom cough and expiratory force may be impaired by the primary disease process. The relationship between expiratory function, cough, and aspiration is less clear in head and neck cancer (HNC) survivors for whom the disease process does not directly impact the lower respiratory system. Our objective was to compare mechanisms of airway clearance (expiratory force and cough) with aspiration status in postradiated HNC survivors. STUDY DESIGN: Cross-sectional study. METHODS: One hundred and three disease-free HNC survivors ≥ 3-months postradiotherapy referred for modified barium swallow studies were prospectively enrolled regardless of dysphagia status. Maximum expiratory pressures (MEPs) and peak cough flow (PCF) measures were taken at enrollment and examined as a function of aspiration status using generalized linear regression methods. RESULTS: Thirty-four (33%) patients aspirated. Maximum expiratory pressure and PCF demonstrated a moderate positive correlation (Pearson's r = 0.35). Adjusting for sex and age, MEPs were on average 19.2% lower (21.1 cm H2 O, 95% confidence interval [CI] 5.3, 36.8) among aspirators. Peak cough flow was also 14.9% lower (59.6 L/minute, 95% CI 15.8, 103.3) among aspirators after adjusting for age and sex. CONCLUSION: Expiratory functions were depressed in postradiated HNC aspirators relative to nonaspirators, suggesting that airway protection impairments may extend beyond disrupted laryngopharyngeal mechanisms in the local treatment field. Exercises to strengthen subglottic expiratory force-generating capacity may offer an adjunctive therapeutic target to improve airway protection in chronic aspirators after head and neck radiotherapy. LEVEL OF EVIDENCE: 2b. Laryngoscope, 128:1615-1621, 2018.

Dynamic Imaging Grade of Swallowing Toxicity (DIGEST): Scale development and validation.

BACKGROUND: The National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) is the universal framework for toxicity reporting in oncology trials. The objective of this study was to develop a CTCAE-compatible modified barium swallow (MBS) grade for the purpose of grading pharyngeal dysphagia as a toxicity endpoint in cooperative-group organ-preservation trials for head and neck cancer (HNC). It was hypothesized that a 5-point, CTCAE-compatible MBS grade (Dynamic Imaging Grade of Swallowing Toxicity [DIGEST]) based on the interaction of pharyngeal residue and laryngeal penetration/aspiration ratings would be feasible and psychometrically sound. METHODS: A modified Delphi exercise was conducted for content validation, expert consensus, and operationalization of DIGEST criteria. Two blinded raters scored 100 MBSs conducted before or after surgical or nonsurgical organ preservation. Intrarater and interrater reliability was tested with weighted κ values. Criterion validity against oropharyngeal swallow efficiency (OPSE), the Modified Barium Swallow Impairment Profile (MBSImP™©), the MD Anderson Dysphagia Inventory (MDADI), and the Performance Status Scale for Head and Neck Cancer Patients (PSS-HN) was assessed with a 1-way analysis of variance and post hoc pairwise comparisons between DIGEST grades. RESULTS: Intrarater reliability was excellent (weighted κ = 0.82-0.84) with substantial to almost perfect agreement between raters (weighted κ = 0.67-0.81). DIGEST significantly discriminated levels of pharyngeal pathophysiology (MBSImP™©: r = 0.77; P < .0001), swallow efficiency (OPSE: r = -0.56; P < .0001), perceived dysphagia (MDADI: r = -0.41; P < .0001), and oral intake (PSS-HN diet: r = -0.49; P < .0001). CONCLUSIONS: With the development of DIGEST, the MBS rating has been adapted to the CTCAE nomenclature of ordinal toxicity grading used in oncology trials. DIGEST offers a psychometrically sound measure for HNC clinical trials and investigations of toxicity profiles, dose responses, and predictive modeling. Cancer 2017;62-70. © 2016 American Cancer Society.

Influence of timing, radiation, and reconstruction on complications and speech outcomes with tracheoesophageal puncture.

BACKGROUND: We evaluated the impact of radiation, reconstruction, and timing of tracheoesophageal puncture (TEP) on complications and speech outcomes. METHODS: Retrospective review identified 145 patients who underwent TEP between 2003 and 2007. RESULTS: Ninety-nine patients (68%) had primary and 46 (32%) had secondary TEP, with complications occurring in 65% and 61%, respectively (p = .96). Twenty-nine patients (20%) had major complications (18 primary and 11 secondary; p = .42). Ninety-four patients (65%) had pre-TEP radiation, 39 (27%) post-TEP radiation, and 12 (8%) no radiation. With patients grouped by TEP timing and radiation history, there was no difference in complications, fluency, or TEP use. With mean 4.7-year follow-up, 82% primary and 85% secondary used TEP for primary communication (p = .66). Free-flap patients used TEP more commonly for primary communication after secondary versus primary TEP (90% vs 50%; p = .02). CONCLUSION: Primary and secondary tracheoesophageal speakers experience similar high rates of complications. Extent of pharyngeal reconstruction, rather than radiation, may be more important in selection of TEP timing. © 2016 Wiley Periodicals, Inc. Head Neck 38: 1765-1771, 2016.

What is a clinically relevant difference in MDADI scores between groups of head and neck cancer patients?

OBJECTIVE/HYPOTHESIS: To describe clinically relevant between-group differences in MD Anderson Dysphagia Inventory (MDADI) scores among head and neck cancer (HNC) patients. STUDY DESIGN: Retrospective cross-sectional study was conducted in 1,136 HNC patients seen for modified barium swallow (MBS) studies. METHODS: The MDADI was administered by written questionnaire at the MBS appointment. MD Anderson Dysphagia Inventory global, composite, and subscale scores were calculated. Anchor-based methods were employed to determine clinically meaningful between-group differences by feeding tube status, aspiration status (per MBS study), and diet level. RESULTS: Mean MDADI scores for the 1,136 patients were: emotional 65.8 ± 17.3, functional 68.1 ± 19.6, physical 60.1 ± 18.6, global 59.3 ± 28.3, and composite 64.0 ± 17.1. Three hundred seventy-eight patients (33%) were feeding tube-dependent; 395 (34.8%) were aspirators; 122 (11%) were nothing per oral (Performance Status Scale-Head and Neck [PSS-HN] diet = 0); and 249 (22%) ate unrestricted, regular diets (PSS-HN diet = 100). Statistically significant (P < 0.0001) between-group differences (feeding tube vs. no feeding tube, aspirator vs. nonaspirator, oral vs. nonoral diet, PSS-HN diet levels) were observed for all mean MDADI scores (global, composite, and subscales). A mean difference of 10 points in composite MDADI scores differentiated feeding tube-dependent from nontube-dependent patients, aspirators from nonaspirators, and distinct PSS-HN diet levels. CONCLUSIONS: We identify that a 10-point between-group difference in composite MDADI scores was associated with clinically meaningful between-group differences in swallowing function. LEVEL OF EVIDENCE: 4. Laryngoscope, 126:1108-1113, 2016.

Evaluation of ototoxicity in patients treated with hyperthermic intraperitoneal chemotherapy (HIPEC) with cisplatin and sodium thiosulfate.

OBJECTIVES: Ototoxic hearing loss associated with intravenous or intra-arterial administration of cisplatin is well documented. However, there is limited data regarding the ototoxic effect of cisplatin when perfused into the abdominal cavity using hyperthermic intraperitoneal chemotherapy (HIPEC). The purpose of this study is to assess and describe ototoxicity in patients treated with HIPEC with cisplatin and sodium thiosulfate for peritoneal surface malignancies. DESIGN: We performed a retrospective chart review (2007-2012) of patients treated for advanced peritoneal malignancies at a tertiary care center using HIPEC with cisplatin and sodium thiosulfate infusion. Thirteen patients (12 males, 1 female) met study criteria. Audiometric thresholds were compared before and after treatment. A 20 dB loss at any single frequency, 10 dB decrease at any two adjacent frequencies, or loss of response at three consecutive test frequencies defined a significant ototoxic change (). RESULTS: Despite minimal hearing change in six patients, none of the 13 patients in our study exhibited a significant ototoxic change in hearing sensitivity post HIPEC with cisplatin at any test interval in any test frequency. CONCLUSIONS: Our findings represent the first objective assessment of ototoxic effect after HIPEC with cisplatin and sodium thiosulfate infusion. Our results suggest that peritoneal perfusion of cisplatin with intravenous perfusion of sodium thiosulfate is not associated with ototoxic changes in hearing sensitivity. Further investigation of the administration and systemic mechanism of absorption of sodium thiosulfate as a potential protection against cisplatin ototoxicity is needed to confirm these findings.

Long-term functional and survival outcomes after induction chemotherapy and risk-based definitive therapy for locally advanced squamous cell carcinoma of the head and neck.

BACKGROUND: The purpose of this study was to evaluate long-term outcomes after induction chemotherapy followed by "risk-based" local therapy for locally-advanced squamous cell carcinoma of the head and neck (SCCHN). METHODS: Forty-seven patients (stage IV; ≥N2b) were enrolled in a phase II trial. Baseline and 24-month functional measures included modified barium swallow (MBS) studies, oropharyngeal swallow efficiency (OPSE), and the MD Anderson Dysphagia Inventory (MDADI). Functional status was assessed at 5 years. RESULTS: Five-year overall survival (OS) was 89% (95% confidence interval [CI], 81% to 99%). A nonsignificant 13% average reduction in swallowing efficiency (OPSE) was observed at 24 months relative to baseline (p = .191). MDADI scores approximated baseline at 24 months. Among 42 long-term survivors (median, 5.9 years), 3 patients (7.1%) had chronic dysphagia. The rate of final gastrostomy dependence was 4.8% (2 of 42). CONCLUSION: Sequential chemoradiotherapy achieved favorable outcomes among patients with locally advanced SCCHN, mainly of oropharyngeal origin. MBS and MDADI scores found modest swallowing deterioration at 2 years, and chronic aspiration was uncommon in long-term survivors.

Adherence to preventive exercises and self-reported swallowing outcomes in post-radiation head and neck cancer patients.

BACKGROUND: To reduce the risk of long-term swallowing complications after radiation, swallowing exercises may be helpful. Both the rate of adherence to swallowing exercises and its impact on future swallowing function are unknown. METHODS: In all, 109 patients with oropharyngeal cancer beginning radiation were tracked for 2 years to determine adherence to swallowing exercises. Participants completed the MD Anderson Dysphagia Inventory (MDADI) 1-2 years after treatment, to assess self-reported swallowing function. Adherence, demographics, tumor, and treatment variables were multivariably regressed onto the MDADI physical subscale score. RESULTS: In accord with speech pathologist documentation, 13% of the participants were fully adherent and 32% were partially adherent. Adherence was associated with the Physical MDADI Subscale score in the multivariate model (p = .01). CONCLUSIONS: The majority of patients with head and neck cancer are nonadherent to swallowing exercise regimens and may benefit from supportive care strategies to optimize their adherence.

Gastrostomy tube placement in patients with hypopharyngeal cancer treated with radiotherapy or chemoradiotherapy: factors affecting placement and dependence.

BACKGROUND: Placement of gastrostomy tubes (g-tubes) in patients with hypopharyngeal cancers undergoing radiation and chemotherapy is generally empirically determined. We examined our experience to identify predictive factors for g-tube placement and length of dependence. METHODS: We performed a retrospective review of all patients with primary hypopharyngeal cancer treated with nonsurgical modalities at a tertiary care center between 2002 and 2008. Rates of g-tube placement and length of dependence on enteral feedings were analyzed in relationship to multiple risk factors. RESULTS: Forty-three patients with hypopharyngeal primary tumors (77%) who had a complete response at the primary site after treatment were included. Thirteen patients (30%) never required g-tube placement. At 1-year follow-up, 11 patients (28%) maintained a g-tube. No clinical variables were significantly associated with g-tube placement. Duration of g-tube dependence was significantly longer in patients with a posterior hypopharyngeal wall primary tumors (p = .026), current smokers (p = .001), and patients with >40 pack-years (p = .010). The duration of g-tube dependence was significantly shorter in those who maintained oral intake at the end of treatment (p = .05), and those who reported adherence to dysphagia exercise regimens (p = .048). CONCLUSION: Approximately one third of patients with hypopharyngeal tumors treated on organ preservation regimens may be able to avoid g-tube placement, but further research is needed to identify clinical factors that predict g-tube placement in this population. A posterior hypopharyngeal wall primary and smoking history correlated with longer gastrostomy tube dependence. Adherence to aggressive targeted swallowing exercise regimens may help to prevent long-term dependence on feeding tubes.

Gastrostomy tube placement in patients with oropharyngeal carcinoma treated with radiotherapy or chemoradiotherapy: factors affecting placement and dependence.

BACKGROUND: Although many patients require nutritional support during radiotherapy or chemoradiotherapy for oropharyngeal cancer, little is known regarding the risk factors that predispose to gastrostomy tube (g-tube) placement and prolonged dependence, or the therapeutic interventions that may abrogate these effects. METHODS: We performed a retrospective medical chart review of patients who were treated for primary oropharyngeal cancer at a tertiary care center from 2003 to 2008. Patients who had a complete response at the primary site at 1-year posttreatment were included. G-tube placement and dependence ≥6 months were evaluated in relationship to site and stage of primary tumor, baseline characteristics, treatment type, smoking status, and swallowing intervention. RESULTS: We evaluated 474 patients (79%) with oropharyngeal cancer; 215 patients (40%) had concurrent chemotherapy, 73 patients (15%) had induction chemotherapy, and 69 patients (15%) had induction chemotherapy followed by concurrent chemotherapy. Two hundred ninety-three patients (62%) received g-tubes, of which 238 (81%) received the g-tube during radiation. At 1-year follow-up, 41 patients (9%) remained dependent on enteral feedings. Placement of g-tubes and prolonged g-tube dependence were significantly more likely in patients with T3 to 4 tumors (p < .001), baseline self-reported dysphagia (p < .001), odynophagia (p < .001), >10% baseline weight loss (p < .001), and in those treated with concurrent chemoradiotherapy. Patients who reported adherence to exercises had significantly lower rates of g-tube placement (p < .001), and duration of dependence was significantly shorter in those who reported adherence to swallowing exercises (p < .001). CONCLUSION: Almost 40% of patients with oropharyngeal cancer treated with nonsurgical organ preservation modalities may avoid feeding tube placement. Factors that predispose to g-tube placement and prolonged dependence include T3 to T4 tumors, concurrent chemotherapy, current smoking status, and baseline swallowing dysfunction or weight loss. Adherence to an aggressive swallowing regimen may reduce long-term dependence on enteral nutrition and limit the rate of g-tube placement overall.

Functional and oncological outcomes of primary versus salvage transoral laser microsurgery for supraglottic carcinoma.

OBJECTIVES: We evaluated the functional and oncological outcomes of transoral laser microsurgery (TLM) in patients with previously untreated supraglottic carcinoma compared with the outcomes in salvage cases after radiation-based treatment. METHODS: We conducted a retrospective case-control study at a single academic tertiary care institution. The functional outcomes were stratified by prior irradiation and were assessed at baseline, less than 1 week after operation, and at last follow-up. RESULTS: Five patients underwent TLM for previously untreated disease, and 5 previously irradiated patients underwent salvage TLM for local failure. No patient required tracheostomy. There was no local recurrence after TLM as primary therapy, and none of those patients required radiotherapy. One salvage patient developed local recurrence. The duration of feeding tube dependence (p = 0.049) and the rates of chronic aspiration (more than 1 month after operation; p = 0.048) were significantly higher in the salvage TLM cases than in the previously untreated cases. The median scores on the PSS-HN Understandability of Speech were 75 ("usually understandable") in the salvage group and 100 ("always understandable") in the previously untreated group. CONCLUSIONS: Both local control and function were better in the previously untreated patients than in the salvage patients. Our findings provide support for the use of TLM as a primary treatment modality for selected supraglottic carcinomas, but also suggest a potential for functional recovery in both previously untreated and salvage cases.

Customization of the voice prosthesis to prevent leakage from the enlarged tracheoesophageal puncture: results of a prospective trial.

OBJECTIVES/HYPOTHESIS: Customization of the tracheoesophageal (TE) voice prosthesis (VP) is often preferred over surgical closure to prevent aspiration around the VP in laryngectomized patients with an enlarged tracheoesophageal puncture (TEP), but it has not been thoroughly evaluated. STUDY DESIGN: Single-institution prospective trial. METHODS: A prospective trial was conducted to evaluate the effectiveness of a customized VP with the addition of an enlarged tracheal and/or esophageal collar in patients with leakage around an enlarged TEP. Absence of leakage around the VP after placement defined immediate effectiveness. Long-term success was defined by the prevention of adverse events related to leakage during the study period. Events that defined failure included: permanent gastrostomy dependence, aspiration pneumonia, and/or surgical TEP closure. RESULTS: Twenty-one patients with enlarged TEP were enrolled (2003-2006). Insertion of a customized VP was unsuccessful in one patient; 145 customizations were performed in the remaining 20 patients (median, 3.5 customizations) during the trial period. Of the customizations, 77% (112/145) prevented leakage immediately after VP insertion. The most common adverse event was dislodgement of the prosthesis (11%) or the collar alone (7%) in 18% (26/145) of customized VP placements. Six patients who died of disease were not evaluable for long-term outcomes. Long-term success was achieved in 80% (12/15) of evaluable patients who avoided permanent gastrostomy, aspiration pneumonia, and surgical TEP closure. CONCLUSIONS: Prosthetic customization offers an effective method to prevent leakage around the VP in many patients with an enlarged TEP, thereby preserving TE voice while avoiding surgical closure in this high-risk population.

Outcomes of elective total laryngectomy for laryngopharyngeal dysfunction in disease-free head and neck cancer survivors.

OBJECTIVE: Total laryngectomy (TL) can be offered for management of chronic aspiration, radionecrosis, and/or airway compromise after head and neck cancer (HNC) treatment. The objective of this study was to evaluate functional outcomes after TL in disease-free HNC survivors. DESIGN: Retrospective case series with chart review. SETTING: The University of Texas MD Anderson Cancer Center. PATIENTS: Twenty-three disease-free HNC survivors who underwent TL for laryngopharyngeal dysfunction. INTERVENTION: TL ± pharyngectomy. MAIN OUTCOME MEASURES: Post-TL swallowing-related (diet, gastrostomy dependence, and pneumonia rates) and communication outcomes. RESULTS: All patients who underwent TL for dysfunction were previously treated with radiotherapy (12/23, 52%) or chemoradiotherapy (11/23, 48%). Preoperative complications included aspiration (22/23, 96%), pneumonia (16/23, 70%), tracheostomy (9/23, 39%), and stricture (7/23, 30%); 17 patients (74%) required enteral/parenteral nutrition, and 13 of 23 (57%) were nothing per oral (NPO). Rates of pneumonia, NPO status, and feeding tube dependence significantly decreased after TL (P < .001). At last follow-up after TL, all patients tolerated oral intake, but 4 (17%) required supplemental enteral nutrition. Continued smoking after radiotherapy and a preoperative history of recurrent pneumonia were significantly (P < .05) associated with final tube dependence and/or diet level. Sixteen patients (70%) underwent tracheoesophageal (TE) puncture, and 57% (13 of 23) communicated using TE voice after TL. CONCLUSION: Salvage TL may improve health status by significantly decreasing the rate of pneumonia and improve quality of life by restoring oral intake in patients with refractory laryngopharyngeal dysfunction after HNC treatment. TE voice restoration may enhance functional outcomes in select patients treated with elective TL for dysfunction.

Late dysphagia after radiotherapy-based treatment of head and neck cancer.

BACKGROUND: Changing trends in head and neck cancer (HNC) merit an understanding of the late effects of therapy, but few studies examine dysphagia beyond 2 years of treatment. METHODS: A case series was examined to describe the pathophysiology and outcomes in dysphagic HNC survivors referred for modified barium swallow (MBS) studies ≥ 5 years after definitive radiotherapy or chemoradiotherapy (January 2001 through May 2011). Functional measures included the penetration-aspiration scale (PAS), performance status scale-head and neck (PSS-HN), National Institutes of Health Swallowing Safety Scale (NIH-SSS), and MBS impairment profile (MBSImp). RESULTS: Twenty-nine patients previously treated with radiotherapy (38%) or chemoradiotherapy (62%) were included (median years posttreatment, 9; range, 5-19). The majority (86%) had oropharyngeal cancer; 52% were never-smokers. Seventy-five percent had T2 or T3 tumors; 52% were N+. The median age at diagnosis was 55 (range, 38-72). Abnormal late examination findings included: dysarthria/dysphonia (76%), cranial neuropathy (48%), trismus (38%), and radionecrosis (10%). MBS studies confirmed pharyngeal residue and aspiration in all dysphagic cases owing to physiologic impairment (median PAS, 8; median NIH-SSS, 10; median MBSImp, 18), whereas stricture was confirmed endoscopically in 7 (24%). Twenty-five (86%) developed pneumonia, half requiring hospitalization. Swallow postures/strategies helped 69% of cases, but no patient achieved durable improvement across functional measures at last follow-up. Ultimately, 19 (66%) were gastrostomy-dependent. CONCLUSIONS: Although functional organ preservation is commonly achieved, severe dysphagia represents a challenging late effect that may develop or progress years after radiation-based therapy for HNC. These data suggest that novel approaches are needed to minimize and better address this complication that is commonly refractory to many standard dysphagia therapies.

Tracheostomaplasty: A surgical method for improving retention of an intraluminal stoma button for hands-free tracheoesophageal speech.

BACKGROUND: We describe a minimally invasive surgical technique, tracheostomaplasty, to overcome anatomical deformities of the stoma that preclude successful retention of a stoma button for hands free tracheoesophageal (TE) speech. METHODS: We conducted a retrospective analysis of 21 patients who underwent tracheostomaplasty after laryngectomy to accommodate an intraluminal valve attachment for hands-free TE speech. RESULTS: Sixteen men and 5 women (median age, 65 years; median follow-up, 27.7 months) underwent tracheostomaplasty; 6 patients developed a mild cellulitis that required therapy and 5 patients required a minor revision surgery. At last follow-up, 15 (71%) patients successfully achieved hands-free TE speech using an intraluminal stoma button. Three patients only retained the intraluminal device to facilitate digital occlusion. Tracheostomaplasty failed in 3 patients because of granulation tissue formation or stomal stenosis. CONCLUSIONS: Tracheostomaplasty is a successful technique to improve intraluminal retention of a stoma button for hands-free TE speech in laryngectomy patients.

Candidate dosimetric predictors of long-term swallowing dysfunction after oropharyngeal intensity-modulated radiotherapy.

PURPOSE: To investigate long-term swallowing function in oropharyngeal cancer patients treated with intensity-modulated radiotherapy (IMRT), and to identify novel dose-limiting criteria predictive for dysphagia. METHODS AND MATERIALS: Thirty-one patients with Stage IV oropharyngeal squamous carcinoma enrolled on a Phase II trial were prospectively evaluated by modified barium swallow studies at baseline, and 6, 12, and 24 months post-IMRT treatment. Candidate dysphagia-associated organs at risk were retrospectively contoured into original treatment plans. Twenty-one (68%) cases were base of tongue and 10 (32%) were tonsil. Stage distribution was T1 (12 patients), T2 (10), T3 (4), T4 (2), and TX (3), and N2 (24), N3 (5), and NX (2). Median age was 52.8 years (range, 42-78 years). Thirteen patients (42%) received concurrent chemotherapy during IMRT. Thirteen (42%) were former smokers. Mean dose to glottic larynx for the cohort was limited to 18 Gy (range, 6-39 Gy) by matching IMRT to conventional low-neck fields. RESULTS: Dose-volume constraints (V30 < 65% and V35 < 35% for anterior oral cavity and V55 < 80% and V65 < 30% for high superior pharyngeal constrictors) predictive for objective swallowing dysfunction were identified by univariate and multivariate analyses. Aspiration and feeding tube dependence were observed in only 1 patient at 24 months. CONCLUSIONS: In the context of glottic laryngeal shielding, we describe candidate oral cavity and superior pharyngeal constrictor organs at risk and dose-volume constraints associated with preserved long-term swallowing function; these constraints are currently undergoing prospective validation. Strict protection of the glottic larynx via beam-split IMRT techniques promises to make chronic aspiration an uncommon outcome.