Silk-Hyaluronic Acid for Vocal Fold Augmentation: Safety Profile and Long-Term Voice Outcomes.

OBJECTIVES: Silk-hyaluronic acid (silk-HA) is a novel vocal fold augmentation material used in humans since July 2020. We aim to describe indications, voice outcomes, and longevity data for silk-HA injectable when used for vocal fold injection (VFI) augmentation in a large cohort of patients with longer-term follow-up than preliminary clinical studies. METHODS: Retrospective chart review of Silk-HA injections for glottic insufficiency (GI) and follow-up between July 2020 and November 2023. Subject demographics, diagnoses, volume of material injected, VHI-10 data, time from injection, need for reinjection, and complications were collected. Blinded perceptual voice analysis of randomly selected pre- and post-intervention voice samples for unilateral vocal fold paralysis patients was performed by three voice-specialized speech-language pathologists, and changes in VHI-10 determined at various time intervals up to 1year and beyond. RESULTS: A total of 160 silk-HA injection procedures were performed: 59% female, with a mean age of 66± 13 (range 21-90) years. Ninety-four subjects had unilateral paralysis (58.4%); the remainder had scar, atrophy, paresis, or a combination thereof. Mean volume of silk-HA injected was 0.24± 0.14 cc. Major complications were rare, most notable for laryngoscopic evidence of hemilaryngeal edema (n = 6, 3.8%), with a readmission rate to hospital of 1.3% (n = 2). There was a statistically significant decrease in paired ΔVHI-10 and CAPE-V ratings for each of the postoperative follow-up intervals. A total of 24 (27.2%) repeat medialization procedures were recommended following silk-HA injection for unilateral paralysis. CONCLUSIONS: This study demonstrates that silk-HA is a safe product for VFI augmentation, and effective injectable for the treatment of GI due to unilateral vocal fold paralysis. Based on the current data, it is reasonable to counsel patients that they should expect benefit for several months following the injection. If patients reach 1year from their injection with a stable and satisfactory outcome, the majority experience ongoing benefit without need for additional procedures, however, the final duration of clinical effect appears to be years, but it is yet to be determined.

Preliminary Results on the Safety and Efficacy of Silk-Hyaluronic Acid for Treatment of Glottic Insufficiency.

OBJECTIVES: Silk-Hyaluronic Acid (Silk-HA) is a novel vocal fold augmentation material that has been used in humans since July 2020. There is a paucity of published data on Silk-HA and its longevity remains a question. This study aimed to evaluate a single surgeon's initial experience performing Silk-HA injection laryngoplasty for the treatment of glottic insufficiency. METHODS: Retrospective chart review of Silk-HA injections between July 2020 and December 2021. Subject demographics, diagnoses, volume of material injected, VHI-10 data, and complications were collected. A blinded perceptual voice analysis of voice samples was performed by two voice-specialized speech-language pathologists (SLP) for a subset of unilateral vocal fold paralysis patients before and 3-months following silk-HA injection. Univariate assessment of the change in VHI-10 and perceptual voice analyses at 3-month follow up was determined. RESULTS: 58 patients (43.1% female) underwent Silk-HA injection with a mean age of 64 (range 21-88). 38 subjects had unilateral paralysis (65.6%), and the remaining had scar, atrophy, paresis or a combination thereof. 49 injections were unilateral (84.5%). Mean volume of silk injected was 0.26 mL. Complications were rare, most notable though for 2 admissions for dyspnea and laryngoscopic evidence of hemi-laryngeal edema (3.4%). Mean change in CAPE-V overall severity rating was -32.9 (P<0.0001), and VHI-10 was -14.6 ± 10 (P=0.0013). 14 patients underwent a repeat silk-HA injection for ongoing glottic insufficiency (loss of augmentation vs under-augmentation). CONCLUSIONS: Preliminary results for Silk-HA show potential for ongoing improvement of glottic insufficiency at 3 months from date of augmentation. Clinician and patient perception of voice outcomes showed overall improvement at three months, though longevity remains to be determined. While overall well tolerated and without serious complications in 96% of the cohort, patients should be counseled on the potential for airway edema and symptomatic dyspnea requiring steroid management and observation.

Rethinking the laryngopharyngeal reflux treatment algorithm: Evaluating an alternate empiric dosing regimen and considering up-front, pH-impedance, and manometry testing to minimize cost in treating suspect laryngopharyngeal reflux disease.

OBJECTIVES/HYPOTHESIS: Empiric proton pump inhibitor (PPI) trials for laryngopharyngeal reflux (LPR) are common. A majority of the patients respond to acid suppression. This work intends to evaluate once-daily, 40 mg omeprazole and once-nightly, 300 mg ranitidine (QD/QHS) dosing as an alternative regimen, and use this study's cohort to evaluate empiric regimens prescribed for LPR as compared to up-front testing with pH impedance multichannel intraluminal impedance (MII) with dual pH probes and high-resolution manometry (HRM) for potential cost minimization. STUDY DESIGN: Retrospective cohort review and cost minimization study. METHODS: A chart review identified patients diagnosed with LPR. All subjects were treated sequentially and outcomes recorded. Initial QD/QHS dosing increased after 3 months to BID if no improvement and ultimately prescribed MII and HRM if they failed BID dosing. Decision tree diagrams were constructed to determine costs of two empiric regimens and up-front MII and HRM. RESULTS: Ninety-seven subjects met the criteria. Responders and nonresponders to empiric therapy were identified. Seventy-two subjects (74%) responded. Forty-eight (67% of responders and 49% of all) improved with QD/QHS dosing. Forty-nine (51%) subjects escalated to BID dosing. Twenty-four subjects (33% of responders and 25% of all) improved on BID therapy. Twenty-five subjects (26%) did not respond to acid suppression. Average weighted cost was $1,897.00 per patient for up-front testing, $3,033.00 for initial BID, and $3,366.00 for initial QD/QHS. CONCLUSIONS: An alternate QD/QHS regimen improved the majority who presented with presumed LPR. Cost estimates demonstrate that the QD/QHS regimen was more expensive than the initial BID high-dose PPI for 6 months. Overall per-patient cost appears less with up-front MII and HRM. LEVEL OF EVIDENCE: 4. Laryngoscope, 127:S1-S13, 2017.

The Development of Conversation Training Therapy: A Concept Paper.

OBJECTIVES: To introduce the conceptual, theoretical, and practical foundations of a novel approach to voice therapy, called conversation training therapy (CTT), which focuses exclusively on voice awareness and efficient voice production in patient-driven conversational narrative, without the use of a traditional therapeutic hierarchy. CTT is grounded in motor learning theory, focused on training target voice goals in spontaneous, conversational speech in the first session and throughout. CTT was developed by a consensus panel of expert clinical voice-specialized speech-language pathologists (SLPs) and patients with voice problems. STUDY DESIGN: This is a prospective, clinical consensus design. METHODS: A preliminary CTT approach to voice therapy was developed by the first and last authors (J.G-S. and A.I.G.) and incorporated six interchangeable tenets: clear speech, auditory/kinesthetic awareness, rapport building, negative practice, basic training gestures, and prosody. Five expert voice-specialized clinical SLPs (consensus group) were then presented CTT and a discussion ensued. Later, an informal interview by a neutral third party person occurred for further recommendations for CTT. RESULTS: The CTT approach was modified to reflect all the consensus groups' recommendations, which included the need for more detail and rationale in the program, troubleshooting suggestions, and the concern for potential challenges for novice clinicians. CONCLUSIONS: CTT is a new therapy approach based on motor learning theory, which exclusively uses patient-driven conversational narrative as the sole therapeutic stimuli. CTT is conceptually innovative because it represents an approach to voice therapy developed without the use of a traditional therapeutic hierarchy. It is also developed using input from patients with voice disorders and expert clinical providers.

Quantifying component parts of indirect and direct voice therapy related to different voice disorders.

Voice therapy changes how people use and care for their voices. Speech-language pathologists (SLPs) have a multitude of choices from which to modify patient's vocal behaviors. Six SLPs performed 1461 voice therapy sessions and quantified the percentage of time spent in eight component parts of indirect and four component parts of direct voice therapy across five common voice disorders. Voice therapy data collection forms were prospectively completed immediately following each therapy visit. The SLPs were free to choose the component parts of voice therapy best suited for their respective patients. Results showed that direct voice therapy represented more than 75% of the treatment time across all voice therapy sessions. In the components of direct voice therapy, there was no statistical difference between percentages of time spent in resonant voice and flow phonation across all voice disorders. However, a significant difference was found for the time spent addressing transfer to conversational speech for muscle tension dysphonia, lesions, and scar than for vocal immobility and atrophy. Interestingly, while SLPs used a more common approach to direct voice therapy across voice disorders, they tended to vary the use of indirect components of therapy across voice disorders with certain components being addressed in greater length for specific voice disorders. Collectively, these results indicate that although SLPs may individualize their approach to indirect voice therapy, when it comes to direct voice therapy, SLPs have a common approach to voice therapy regardless of voice disorder.

Evidence for primary laryngeal inhalant allergy: a randomized, double-blinded crossover study.

BACKGROUND: Despite anecdotal reports, no controlled studies to date link allergen exposure with a change in vocal function or dysphonia. The aim of this study was to determine whether allergen exposure in susceptible individuals impairs vocal function. METHODS: The study was a prospective, double-blind, placebo-controlled study in which subjects serve as their own controls. The participants were 5 inhalant allergic adults with suspected dysphonia from allergies, without evidence of reactive lower airways based on methacholine challenge. All subjects were exposed to 2 experimental conditions in which they were challenged with (1) orally inhaled diluent placebo on 1 day, and (2) orally inhaled allergen on another day. Conditions were randomly ordered across subjects and separated by at least 48 hours. Phonatory threshold pressure (PTP) at the 80th percentile pitch was measured prior to diluent and allergen challenge, and 15 and 60 minutes postchallenge to assess potential change in vocal function after challenge testing. RESULTS: A repeated measures ANOVA revealed a significant main effect for treatment (allergen vs placebo, p = 0.013) with greater PTP required post-allergen challenge compared to placebo and an effect size of 0.821. CONCLUSION: A primary causal relationship between allergen exposure and impaired vocal function, as assessed by PTP, was observed in adults with documented allergy independent of asthma or nasal exposure. The current design establishes a safe model for laryngeal inhalant allergen challenge.

Vocal allergy: recent advances in understanding the role of allergy in dysphonia.

PURPOSE OF REVIEW: To examine recent advances in our understanding of the laryngeal effects of allergies with particular attention to the impact on vocal production. RECENT FINDINGS: A growing body of literature suggests an association between allergies and dysphonia evidenced by the increased likelihood of singers with vocal complaints to self-identify allergic rhinitis by standardized questionnaire compared with singers without vocal complaints, the severity of vocal symptoms of allergic patients in relationship to nonallergic controls, and the increased vocal complaints of allergic individuals from the nonallergy to allergy seasons. Arguments have also been made for the misdiagnosis of allergic dysphonia as laryngopharyngeal reflux disease. A recent study has demonstrated the first evidence of a causal relationship between allergen exposure and voice changes in the absence of a sinus or lower airway allergic response. SUMMARY: New evidence has highlighted the likelihood that allergies are indeed associated with dysphonia. The existence of a direct allergic response in the larynx has meaningful implications for the diagnosis and treatment of dysphonia. Further research is needed to identify the underlying pathways mediating the laryngeal response to allergy so that improved diagnostic and therapeutic techniques can be developed.